Q2 2024 Eyenovia Inc Earnings Call

August 12, 2024

Speaker Change: and John Rowe. Thank you. Thank you. Thank you. Thank you.

unknown: John Gandolfo, John Gandolfo, John Gandolfo

Operator: Greetings. Welcome to Eyenovia's second quarter 2024 earnings call. At this time, all participants are in a listen-only mode. A question and answer session will follow the formal presentation. If anyone should require operator assistance during the conference, please press star zero on your telephone keypad. Please note this conference is being recorded. I would now like to turn the conference over to Eric Ribner, Investor Relations. Thank you. You may begin.

Operator: Greetings, and welcome to Eyenovia's second quarter 2024 earnings call. At this time, all participants are in a listen only mode.

Operator: A question and answer session will follow the formal presentation. If anyone should require operator assistance during the conference, please press star zero on your telephone keypad. Please note this conference is being recorded. I would now like to turn the conference over to Eric Ribner, Investor Relations. Thank you. You may begin.

Speaker Change: and Mark Ruffalo. Thank you. Thank you. Thank you. Thank you.

Speaker Change: Greetings. Welcome to Inovia's second quarter 2024 earnings call.

Speaker Change: At this time, all participants are in a listen-only mode. A question and answer session will follow the formal presentation. If anyone should require operator assistance during the conference, please press star zero on your telephone keypad.

Speaker Change: Please note this conference is being recorded. I would now like to turn the conference over to Eric Ribner, Investor Relations. Thank you. You may begin.

Eric Ribner: Good afternoon, and welcome to Eyenovia's second quarter 2024 earnings conference call and audio webcast. With me today are Eyenovia's Chief Executive Officer, Michael Rowe, Chief Financial Officer, John Gandolfo, and Chief Operating Officer, Bren Kern. This afternoon, we issued a press release announcing financial results for the three months ended June 30th, 2024. We encourage everyone to read today's press release as well as Eyenovia's quarterly report on Form 10-Q for the quarter ended June 30th, 2024, which was just filed with the SEC.

Eric Ribner: Good afternoon and welcome to Inovia's second quarter 2024 earnings conference call and audio webcast.

Speaker Change: With me today are Inovia's Chief Executive Officer Michael Rowe, Chief Financial Officer John Gandolfo, and Chief Operating Officer Bren Kern.

Eric Ribner: This afternoon, we issued a press release announcing financial results for the three months ended June 30, 2024. We encourage everyone to read today's press release as well as Eyenovia's quarterly report on Form 10-Q for the quarter ended June 30, 2024, which was just filed with the SEC. The company's press release and annual report are also available on our website at www.eyenovia.com. In addition, this conference call is being webcast on the company's website and will be archived and available for replay for future reference. Please note that on today's call, we will be discussing products, product concepts, and candidates, some of which have yet to receive FDA approval.

Speaker Change: This afternoon, we issued a press release announcing financial results for the three months ended June 30th, 2024. We encourage everyone to read today's press release as well as Inovia's quarterly report on Form 10-Q for the quarter ended June 30th, 2024.

Eric Ribner: The company's press release and annual report are also available on our website at www.eyenovia.com. In addition, this conference call is being webcast on the company's website and will be archived and available for replay for future reference. Please note that on today's call, we will be discussing products, product concepts, and candidates, some of which have yet to receive FDA approval. Please also note that certain information discussed on today's call is covered under the safe harbor provisions of the Private Securities Litigation Reform Act.

Speaker Change: which was just filed with the SEC.

Speaker Change: The company's press release and annual report are also available on our website at www.inovia.com. In addition, this conference call is being webcast on the company's website and will be archived and available for replay for future reference.

Speaker Change: Please note that on today's call, we will be discussing products, product concepts, and candidates, some of which have yet to receive FDA approval. Please also note that certain information discussed on the call today is covered under the safe harbor provisions of the Private Securities Litigation Reform Act.

Eric Ribner: Please also note that certain information discussed on the call today is covered under the safe harbor provisions of the Private Securities Litigation Reform Act. We caution listeners that during the call, Eyenovia's management will be making forward-looking statements. However, actual results could differ materially from those stated or implied by these forward-looking statements due to risks and uncertainties associated with the company's business.

Eric Ribner: We caution listeners that during the call, Eyenovia's management will be making forward-looking statements. However, actual results could differ materially from those stated or implied by these forward-looking statements due to risks and uncertainties associated with the company's business.

Speaker Change: We caution listeners that during the call, Inovia's management will be making forward-looking statements. Actual results could differ materially from those stated or implied by these forward-looking statements due to risks and uncertainties associated with the company's business.

Eric Ribner: These forward-looking statements are subject to a number of risks, which are described in more detail in our quarterly Form 10-Q, as well as in our annual reports on Form 10-K. This conference call contains time-sensitive information that is accurate only as of the date of this live broadcast, August 12, 2024. With that said, Eyenovia undertakes no obligation to revise or update any forward-looking statements to reflect events or circumstances after the date of this conference call, except as may be required by the applicable securities law. Michael?

Speaker Change: These forward-looking statements are subject to a number of risks, which are described in more detail in our quarterly Form 10-Q as well as our annual reports on Form 10-K.

Speaker Change: This conference call contains time-sensitive information that is accurate only as of the date of this live broadcast, August 12, 2024.

Speaker Change: Inovia undertakes no obligation to revise or update any forward-looking statements to reflect events or circumstances after the date of this conference call except as may be required by the applicable securities law.

Speaker Change: With that said, I'd like to turn the call over to Michael Rowe, Inovia's Chief Executive Officer. Michael?

Michael Rowe: Thank you, Eric, and welcome to our second quarter 2024 financial results conference call. During the second quarter, we advanced several initiatives that we discussed previously that are designed to strengthen the inherent value of Eyenovia. These include our novel OptiJet dispensing technology, which we recently bought into three dry eye collaboration agreements with significant Mid-Term Potential Value, two FDA-approved products, midcombi and clovetazole, and micro... Micropine is the only drug-device combination therapy in late phase 3 development for use in pediatric progressive myopia and is rapidly approaching a pivotal data readout.

Michael Rowe: Thank you, Eric, and welcome to our second quarter 2024 financial results conference call. During the second quarter, we advanced several initiatives that we discussed previously that are designed to strengthen the inherent value of Eyenovia. These include our novel OptiJet dispensing technology, which we recently bought into three dry eye collaboration agreements of Significant Midterm Potential Value, two FDA-approved products, midcombi and cobetasol, and microparticles. Micropine is the only drug-device combination therapy in late Phase III development for use in pediatric progressive myopia, and is rapidly approaching a pivotal data readout.

Michael Rowe: These include our novel OptiJet dispensing technology, which we recently bought into three dry eye collaboration agreements of significant mid-term potential value.

Speaker Change: Two FDA-approved products, midcombi and cobetasol, and micropine. Micropine is the only drug-device combination therapy in late Phase III development for use in pediatric progressive myopia, and is rapidly approaching a pivotal data readout.

Michael Rowe: At Eyenovia, our vision is to enhance yours by making topical ophthalmic therapies easier to use and easier to live with. By addressing a broad range of patient and eye care practitioner needs with novel technologies and products that are designed to be user-friendly, we believe we are building a strong foundation for accelerating value creation in 2025 and beyond. I would like to begin this afternoon with an update on my... Our drug-device combination of low-dose adrenaline administered with our proprietary OptiJet dispenser.

Speaker Change: At Inovia, our vision is to enhance yours by making topical ophthalmic therapies easier to use and easier to live with by addressing a broad range of patient and eye care practitioner needs.

Speaker Change: With novel technologies and products that are designed to be user-friendly, we believe we are building a strong foundation for accelerating value creation in 2025 and beyond.

Michael Rowe: I would like to begin this afternoon with an update on my... Our drug-device combination of low-dose ad, administered with our proprietary OptiJet dispenser. This regimen is being developed as a potential treatment for progressive myopia in children. Recall that micropine is currently being evaluated in the ongoing late phase three chaperone study. Pediatric progressive myopia is increasingly recognized as an epidemic in both the United States and China. Pediatric myopia is a condition in which the eye abnormally elongates, putting children at risk of losing functional vision and can potentially result in severe retinal complications.

Speaker Change: I would like to begin this afternoon with an update on MicroPy.

Speaker Change: Our drug-device combination of low-dose atropine administered with our proprietary OptiJet dispenser.

Michael Rowe: This regimen is being developed as a potential treatment for progressive myopia in children. Recall that micropine is currently being evaluated in the ongoing late phase 3 chaperone study. Pediatric progressive myopia is increasingly recognized as an epidemic in both the United States and China. Pediatric myopia is a condition in which the eye abnormally elongates, putting children at risk of losing functional vision and can potentially result in severe retinal complications.

Speaker Change: This regimen is being developed as a potential treatment for progressive myopia in children. Recall that mycopine is currently being evaluated in the ongoing Late Phase III chaperone study.

Michael Rowe: In the U.S. alone, of the nearly 20 million children with myopia, approximately 5 million are considered at risk of losing functional vision due to this disease. Additionally, the rights to micropine have been licensed to Arctic Vision, our partner in China, who is conducting a clinical trial for submission to the Chinese authorities. While glasses and contact lenses are the current standard of care for children diagnosed with myopia, they only slow the disease progression but do not cure the disease.

Speaker Change: Pediatric progressive myopia is increasingly recognized as an epidemic in both the United States and China.

Speaker Change: Pediatric myopia is a condition in which the eye abnormally elongates, putting children at risk of losing functional vision and can potentially result in severe retinal complications.

Speaker Change: In the U.S. alone, of the nearly 20 million children with myopia, approximately 5 million are considered at risk of losing functional vision due to this disease.

Speaker Change: Additionally, the rights to micropine have been licensed to Arctic Vision, our partner in China, who is conducting a clinical trial for submission to the Chinese authority.

Speaker Change: While glasses and contact lenses are the current standard of care for children diagnosed with myopia, they only slow disease progression, but do not cure the disease.

Michael Rowe: Current treatments are often not well-tolerated or appropriate for the youngest, most vulnerable patients, who frequently struggle with discomfort and cityscape. Atropine has been shown in prior studies such as LAMP and ADAM to slow myopia progression by as much as 60%. And our proprietary atropine formulation, administered with the OptiJet, may offer benefits far beyond what could be obtained with a traditional eye drop. Using the OptiJet technology, children in the Chaperone study as young as 6 years old are dosing themselves nightly with minimal parental supervision.

Michael Rowe: Current treatments are often not well-tolerated or appropriate for the youngest, most vulnerable patients, who frequently struggle with discomfort and cityscape. Atropine has been shown in prior studies such as LAMP and ADAM to slow myopia progression by as much as 60 percent. And our proprietary atropine formulation, administered with the OptiJet, may offer benefits far beyond what could be obtained with a traditional eye drop. Using the OptiJet technology, children in the Chaperone study as young as 6 years old are dosing themselves nightly with minimal parental supervision.

Speaker Change: Current treatments are often not well tolerated or appropriate for the youngest, most vulnerable patients who frequently struggle with discomfort and fit issues.

Speaker Change: Atropine has been shown in prior studies such as LAMP and ADAM to slow myopia progression by as much as 60% and our proprietary atropine formulation administered with the OptiJet may offer benefits far beyond what could be obtained with a traditional eye drop.

Michael Rowe: They can self-administer the dose because the OptiJet doesn't require any head tilting or manipulation of an eyedropper bottle, making aiming with a built-in mirror and medication administration achievable. The children can see exactly where they are spraying the medication and become familiar and comfortable with the dosing process quickly, which can reduce dosing anxiety and minimize the myriad of struggles parents face with dosing children with conventional eye drops. The side effects of atropine dosed with the optogen were notably mild and transient in the chaperone study.

Speaker Change: With the OptiJet technology, children in a chaperone study as young as six years old are dosing themselves nightly with minimal parental supervision.

Michael Rowe: They can self-administer the dose because the OptiJet doesn't require any head tilting or manipulation of an eyedropper bottle, aiming with a built-in mirror, and medication administration is achievable. The children can see exactly where they are spraying the medication and become familiar and comfortable with the dosing process quickly, which can reduce dosing anxiety and minimize the myriad of struggles parents face with dosing children with conventional eye drops.

Speaker Change: They can self-administer the dose because the OptiJet doesn't require any head tilting or manipulation of an eyedropper bottle.

Speaker Change: making Aiming with a Built-in Mirror.

Speaker Change: and Medication Administration Achievable.

Speaker Change: The children can see exactly where they are spraying medication and become familiar and comfortable with the dosing process quickly, which can reduce dosing anxiety and minimizes the myriad of struggles parents face with dosing children with conventional eye drops.

Michael Rowe: The side effects of atropine dosed with the optogif have been notably mild and transient in the chaperone study. These results are consistent with what we have come to expect with our advanced drug device dosing system. Throughout the trial, we have been measuring the performance of the OptiJet with embedded firmware that allows study doctors to better understand how and when the device has been used. Each time the dosing button is pressed to administer medication, the device records the event and stores the information.

Speaker Change: The side effects of atropine dosed with the OptiJet have been notably mild and transient in the chaperone study. These results are consistent with what we have come to expect with our advanced drug device dosing system.

Michael Rowe: These results are consistent with what we have come to expect with our advanced drug device dosing system. Throughout the trial, we have been measuring the performance of the OptiJet with embedded firmware that allows study doctors to better understand how and when the device has been used. Each time the dosing button is pressed to administer medication, the device records the event and stores the information.

Speaker Change: Throughout the trial, we have been measuring the performance of the OptiJet with embedded firmware that allows study doctors to better understand how and when the device has been used. Each time the dosing button is pressed to administer medication, the device records the event and stores the information.

Michael Rowe: This information can be accessed and reviewed by the clinic staff during visits for the study. For the commercial product, we anticipate Micropine will be equipped with our OptiCare system, which can notify patients and their parents when to administer their spray dose as well as communicate important compliance and adherence information to the treating physician. Our engineers are working today on plans to validate the system for FDA approval. We are continuing to advance the Phase III chaperone study and are planning for an efficacy analysis in the fourth quarter of this year once a statistically sufficient number of patients have reached the study efficacy endpoint.

Michael Rowe: This information can be accessed and reviewed by the clinic staff during visits for the study. For the commercial product, we anticipate Micropine will be equipped with our OptiCare system, which can notify patients and their parents when to administer their spray dose, as well as communicate important compliance and adherence information to the treating physician. Our engineers are working today on plans to validate the system for FDA approval. We are continuing to advance the Phase III chaperone study and are planning for an efficacy analysis in the fourth quarter of this year once a statistically sufficient number of patients have reached the study efficacy endpoint.

Speaker Change: This information can be accessed and reviewed by the clinic staff during visits for the study.

Speaker Change: For the commercial product, we anticipate Micropine will be equipped with our OptiCare system.

Speaker Change: which can notify patients and their parents when to administer their spray dose as well as communicate important compliance and adherence information to the treating physician. Our engineers are working today on plans to validate the system for FDA approval.

Speaker Change: We are continuing to advance the Phase III chaperone study and are planning for an efficacy analysis in the fourth quarter of this year, once a statistically sufficient number of patients have reached the study efficacy end point.

Michael Rowe: If the results are positive, this would significantly de-risk the program and potentially enable an NDA submission as soon as late 2025 or early 2026. Recall that the FDA has agreed that a properly conducted single phase 3 study could be sufficient for an NDA filing and approval. As we have mentioned before, we believe this program would then present a very attractive opportunity for commercialization, either by us or a larger partner. Turning now to dry ice, since our last quarterly update, we have executed three collaboration agreements that leverage our Opti-Jet dispenser for dry ice.

Speaker Change: If the results are positive, this would significantly de-risk the program and potentially enable an NDA submission as soon as late 2025 or early 2026.

Speaker Change: Recall that the FDA has agreed that a properly conducted single phase 3 study could be sufficient for an NDA filing and approval.

Michael Rowe: As we have mentioned before, we believe this program would then present a very attractive opportunity for commercialization, either by us or a larger partner. Turning now to dry eye, since our last quarterly update, we have executed three collaboration agreements that leverage our OptiJet dispenser for dry eye. Symptoms of dry eye can significantly interfere with daily life, leaving many patients unsatisfied with currently available therapy.

Speaker Change: As we have mentioned before, we believe this program would then present a very attractive opportunity for commercialization either by us or a larger partner.

Michael Rowe: According to a recent survey, while 48% of patients reported carefully following their treatment plans, only 13% experienced lasting relief. Nearly 16 million Americans suffer from dry eye, with treatment expenditures totaling over $3 billion in the U.S. and $5 billion globally. Beginning with Formosa, we recently announced that we signed an agreement to develop a formulation of clobetazole in the OptiJet as a potential treatment for acute dry eye. This development program, which would require two 15-day clinical trials, would be free of any upfront fees from Eyenovia or development milestones from Formosa until the product is FDA approved. This is an ideal extension of our existing relationship with Hermosa and demonstrates how we can extend the use of the NITROP formulation through incorporation of the OPTI.

Speaker Change: Turning now to dry eye, since our last quarterly update, we have executed three collaboration agreements that leverage our OptiJet dispenser for dry eye.

Michael Rowe: Symptoms of dry eye can significantly interfere with daily life, leaving many patients unsatisfied with currently available therapy. In a recent survey, while 48% of patients reported carefully following their treatment plans, only 13% experienced lasting relief.

Speaker Change: Symptoms of dry eye can significantly interfere with daily life, leaving many patients unsatisfied with currently available therapies.

Speaker Change: According to a recent survey, while 48% of patients reported carefully following their treatment plans,

Michael Rowe: Nearly 16 million Americans suffer from dry eye, with treatment expenditures totaling over $3 billion in the U.S. and $5 billion globally. Beginning with Formosa, we recently announced that we have signed an agreement to develop a formulation of clobetazole in the OptiJet as a potential treatment for acute dry eye. This development program, which would require two 15-day clinical trials, would be free of any upfront fees from Eyenovia or development milestones to Formosa until the product is FDA approved. This is an ideal extension of our existing relationship with Hermosa and demonstrates how we can extend the use of an eye drop formulation through incorporation of the OptiChem.

Speaker Change: Only 13% experienced lasting relief.

Speaker Change: Nearly 16 million Americans suffer from dry eye, with treatment expenditures totaling over $3 billion in the U.S. and $5 billion globally.

Speaker Change: Beginning with Formosa, we recently signed an agreement to develop a formulation of clobetazole in the OptiJet.

Speaker Change: That's a potential treatment for acute dry eye.

Speaker Change: This development program, which would require two 15-day clinical trials, would be free of any upfront fees from Inovia or development milestones to Formosa until the product is FDA approved.

Speaker Change: This is an ideal extension of our existing relationship with HERMOSA and demonstrates how we can extend the use of an eye drop formulation through incorporation of the OptiJet.

Michael Rowe: We also recently signed a collaboration agreement with Senju Pharmaceutical to develop a new adjunctive treatment for chronic dry eye disease. Under the terms of that agreement, we will jointly work to develop Senju's Epithelial Wound Healing Cavitate, SJP 35, for use with our OptiJet dispenser. This potential drug device combination is unique because it would be designed for use alongside other dry eye medication. In other words, it complements existing products rather than competing with them.

Michael Rowe: We also recently signed a collaboration agreement with Senju Pharmaceutical to develop a new adjunctive treatment for chronic dry eye disease. Under the terms of that agreement, we will jointly work to develop Senju's Epithelial Wound Healing Cabinet, SJP 35, for use with our OptiJet dispenser. This potential drug device combination is unique because it would be designed for use alongside other dry eye medication. In other words, it complements existing products rather than competing with them.

Speaker Change: We also recently signed a collaboration agreement with Senju Pharmaceutical to develop a new adjunctive treatment for chronic dry eye disease. For the terms of that agreement, we will jointly work to develop Senju's epithelial wound healing candidate, SJP35, for use with our OptiJet dispenser.

Speaker Change: This potential drug-device combination is unique because it would be designed for use alongside other dry eye medications.

Speaker Change: In other words, it complements existing products rather than competing with them.

Michael Rowe: We are working towards a meeting with the FDA later this year, followed by completion of a Phase IIb study in 2025. If successful, the companies will expand this collaboration to initiate two phase three studies by 2026. SJP 35 has been shown to be well tolerated in prior phase 1 and phase 2 studies as a standard eyedrop, tested at multiple doses in over 250 subjects. And continuing on with the topic of dry eyes, in late February, we entered into a collaboration agreement with SGN Nanopharma, an innovation-led, clinical-stage, nanopharmaceutical company focused on creating impactful, best-in-class nanotherapeutics targeting large, unmet medical STN's proprietary mycellular nanoparticle platform allows for the distribution of an active pharmaceutical ingredient into three or more phases, thereby improving its bioavailability, biodistribution, and pharmacokinetics.

Speaker Change: We are working towards a meeting with the FDA later this year, followed by completion of a Phase 2B study in 2025. If successful, the companies will expand this collaboration to initiate two Phase 3 studies by 2026.

Speaker Change: SJP 35 has been shown to be well tolerated at prior phase 1 and phase 2 studies as a standard eyedrop tested at multiple doses in over 250 subjects.

Speaker Change: And continuing on with the topic of dry eye, in late February, we entered into a collaboration agreement with SGN Nanopharma, an innovation-led, clinical stage, nanopharmaceutical company focused on creating impactful, best-in-class nanotherapeutics targeting large unmet medical needs.

Speaker Change: SGN's proprietary mycellular nanoparticle platform allows for the distribution of an active pharmaceutical ingredient into three or more phases, thereby improving its bioavailability, biodistribution, and pharmacokinetics.

Michael Rowe: Per the terms of the agreement, Eyenovia has been conducting feasibility and process manufacturing testing with SGN's Phase 3 ready ophthalmic cyclosporine formulation, SGN 101, in combination with our Gen 2 OptiJet device as a potential treatment for chronic dry eyes. A combination of a faster-working cyclosporine than the OptiJet could be a powerful new treatment option for this large and underserved market. With the SGN collaboration, we may have this phase three ready asset next year for chronic dry eye.

Speaker Change: Per the terms of the agreement, Inovia has been conducting feasibility and process manufacturing testing with SGN Phase 3 ready ophthalmic cyclosporine formulation, SGN 101, in combination with our Gen 2 OptiJet device.

Speaker Change: as a potential treatment for chronic dry eye.

Speaker Change: A combination of a faster-working cyclosporine than the Opti-Jet could be a powerful new treatment option for this large and underserved market. With the SGN collaboration, we may have this Phase III-ready asset next year in chronic dry eye.

Michael Rowe: With these three agreements, we can potentially cover the entire dry eye market, which is a $3 billion annual addressable market in the United States with a multi-million patient population and significant unmet needs. We anticipate achieving this through an acute product for flare-ups with Promosa, an adjunctive chronic medication with Sendu, and a chronic medication with SGM. Now I'd like to discuss Clobetazole. The FDA approved Clobetazole on March 4th, and shortly after, the new drug application or NDA for this product was transferred to us from Formosa.

Michael Rowe: With these three agreements, we can potentially cover the entire dry eye market, which is a $3 billion annual addressable market in the United States with a multi-million patient population and significant unmet needs. We anticipate achieving this through an acute product for flare-ups with promosa, an adjunctive chronic medication with Sendu, and a chronic medication with SGM. Now I'd like to discuss Clovetazole.

Speaker Change: With these three agreements, we can potentially cover the entire dry eye market, which is a $3 billion annual addressable market in the United States with a multi-million patient population and significant unmet needs.

Speaker Change: We anticipate achieving this through an acute product for flare-ups with PROMOSA, an adjunctive chronic medication with SENDU, and a chronic medication with SGN.

Michael Rowe: The FDA approved Clovetazole on March 4th, and shortly after, the new drug application or NDA for this product was transferred to us from Formosa. Thus, Betasol is the first new ophthalmic steroid approved in the U.S. in over 15 years. Well, that addresses many unmet needs in ophthalmic steroids with its highly differentiated clinical and pharmacologic profile. It offers twice daily dosing, and from a safety perspective, fewer than 1% of patients experience sudden eye pressure increases, which may be more common with other steroids. Intraocular inflammation and eye pressure spikes are the primary safety concerns for eye surgeons, as they can lead to serious clinical consequences, complications, and non-reimbursable costs for providers.

Speaker Change: Now I'd like to discuss Clovetazole. The FDA approved Clovetazole on March 4th, and shortly after, the New Drug Application, or NDA, for this product was transferred to us from Formosa.

Michael Rowe: So Betasol is the first new ophthalmic steroid approved in the U.S. in over 15 years. It addresses many unmet needs in ophthalmic steroids with its highly differentiated clinical and pharmacologic profile. It offers twice-daily dosing, and from a safety perspective, fewer than 1% of patients experience sudden eye pressure increases, which may be more common with other steroids. Intraocular inflammation and eye pressure spikes are the primary safety concerns for eye surgeons, as they can lead to serious clinical consequences, complications, and non-reimbursable costs for providers.

Speaker Change: Obedazole is the first new ophthalmic steroid approved in the U.S. in over 15 years. Obedazole addresses many unmet needs in ophthalmic steroids with its highly differentiated clinical and pharmacologic profile.

Speaker Change: It offers twice daily dosing and from a safety perspective, fewer than 1% of patients experience sudden eye pressure increases, which may be more common with other steroids.

Speaker Change: Intraocular inflammation and eye pressure spikes are the primary safety concerns for eye surgeons.

Speaker Change: as they can lead to serious clinical consequences, complications, and non-reimbursable costs for providers. We believe that clobetazole has the potential to become the leading option in the post-surgical space.

Michael Rowe: We believe that Clobetazole has the potential to become the leading option in the post-surgical space. This unique steroid is the first product developed using PROMOSA's proprietary APNT nanoparticle formulation platform. Patients do not have to shake the product prior to use, and that is just one of the unique elements of our approved label.

Michael Rowe: We believe that Clometasol has the potential to become the leading option in the post-surgical space. This unique steroid is the first product developed using PROMOSA's proprietary APNT nanoparticle formulation platform. Patients do not have to shake the product prior to use, and that is just one of the unique elements of our approved label.

Speaker Change: This unique steroid is the first product developed using Pirmosa's proprietary APNT nanoparticle formulation platform.

Speaker Change: Patients do not have to shake the product prior to use and that is just one of the unique elements of our approved label. While that may seem minor it highlights a key difference between fobetasol and other ophthalmic steroids.

Michael Rowe: While that may seem minor, it highlights the key difference between fobetasol and other ophthalmic steroids. Flabetasol's efficacy and its previously discussed safety profile further set it apart. In clinical results, nearly 9 out of 10 patients experienced complete relief from post-surgical pain, and 60% had total resolution of inflammation within 15 days after ocular surgery, with all side effects occurring in less than 2% of cases. Moreover, twice daily dosing, without the need for titration, is a clear advantage, especially compared to treatments requiring up to four doses a day.

Michael Rowe: While that may seem minor, it highlights a key difference between Fobidazole and other ophthalmic steroids. LaBedisole's efficacy and its previously discussed safety profile further set it apart. In clinical results, nearly 9 out of 10 patients experienced complete relief from post-surgical pain, and 60% had total resolution of inflammation within 15 days after ocular surgery with all side effects occurring in less than 2% of cases. Moreover, twice daily dosing without the need for titration is a clear advantage, especially compared to treatments requiring up to four doses a day.

Speaker Change: Labedisol's efficacy and its previously discussed safety profile further set it apart.

Speaker Change: In clinical results, nearly 9 out of 10 patients experienced complete relief from post-surgical pain and 60% had total resolution of inflammation within 15 days after ocular surgery, with all side effects occurring in less than 2% of cases.

Speaker Change: Moreover, twice daily dosing without the need for titration is a clear advantage, especially compared to treatments requiring up to four doses a day.

Michael Rowe: This simplicity is particularly valuable for eye surgery patients who often use multiple medications during recovery. Both eye doctors and patients will appreciate this advancement, which may simplify the treatment regimen. It is estimated that more than 7 million ocular surgeries are performed annually in the U.S., with topical ocular steroids and steroid combinations currently generating $1.3 billion in sales.

Speaker Change: This simplicity is particularly valuable for eye surgery patients who often use multiple medications during recovery. Both eye doctors and patients will appreciate this advancement which may simplify the treatment regimen.

Speaker Change: It is estimated that more than 7 million ocular surgeries are performed annually in the U.S. with topical ocular steroids.

Michael Rowe: This represents a significant market opportunity. We believe we can capture a mid-single-digit market share over the next three or four years, as previously mentioned. Our 10 sales representatives, who we began hiring over the last few months and completed their training just two weeks ago, are today pre-qualifying eye surgery offices for their interest in clovetazole. Each representative or key account manager aims to secure 50 offices in preparation for the product launch in the United States.

Speaker Change: and Steroid Combinations, currently generating $1.3 billion in sales. This represents a significant market opportunity. We believe we can capture a mid-single-digit market share over the next three or four years, as previously mentioned.

Speaker Change: Our 10 sales representatives who we began hiring over the last few months

Speaker Change: and completed their training just two weeks ago are today pre-qualifying eye surgery offices for their interest in clovetazole. Each representative or key account manager aims to secure 50 offices in preparation for the product launch in the United States.

Michael Rowe: This approach will allow us to hit the ground running and build upon early success. We had previously communicated that we were planning a commercial launch this summer, which would be supplemented by our co-promotion agreement with Nova Bay Pharmaceuticals. This is still our intent as we await the product arriving here from Formosa. In the meantime, we have expanded our promotional arrangement with Novavag to include additional products already used by our core customers, enabling our sales force to operate efficiently while they set the stage for what we believe will be a game-changer in ocular steroid treatment. Now, I'll provide an update on MidCombi.

Michael Rowe: This approach will allow us to hit the ground running and build upon early success. We had previously communicated that we were planning a commercial launch this summer, which would be supplemented by our co-promotion agreement with Novavax Pharmaceuticals. This is still our intent as we await the product arriving here from Formosa. In the meantime, we have expanded our promotional arrangement with Novavag to include additional products already used by our core customers, enabling our sales force to operate efficiently while they set the stage for what we believe will be a game-changer in ocular steroid treatment.

Speaker Change: This approach will allow us to hit the ground running and build upon early success.

Speaker Change: We had previously communicated that we were planning on a commercial launch this summer, which would be supplemented by our co-promotion agreement with Nova Bay Pharmaceuticals.

Speaker Change: This is still our intent as we await the product arriving here from Formosa. In the meantime, we have expanded our promotional arrangement with NovaVeg to include additional products already used by our core customers.

Speaker Change: enabling our sales force to operate efficiently while they set the stage for what we believe will be a game-changer in the ocular steroid treatment.

Michael Rowe: Now I'll provide an update on MidCombi. It is the first and only FDA-approved fixed combination of two well-known pupil dilation drugs, picamide and phenolephrine, and the first approved ophthalmic spray using the OptiJet platform. Now that the hiring and training of our sales force is complete, and we have satisfied licensing requirements in states covering over two-thirds of the U.S. population, we are promoting Vidconbi in earnest. As of June 30th, we had trained and converted 63 offices.

Michael Rowe: It is the first and only FDA-approved fixed combination of two well-known pupil dilation drugs, tropicamide and phenolephrine, and the first approved ophthalmic spray using the OptiJet platform. Now that the hiring and training of our sales force is complete, and we have satisfied licensing requirements in states covering over two-thirds of the U.S. population, we are promoting VidConvi in earnest. As of June 30th, we had trained and converted 63 offices.

Speaker Change: Now I'll provide an update on MidCombi. It is the first and only FDA-approved fixed combination of two well-known pupil dilation drugs for picamide and phenylephrine, and the first approved ophthalmic spray using the OptiJet platform.

Michael Rowe: This was up from approximately eight offices three months earlier. Many of those customers you'll see on our social media channels sharing their positive experiences with the product. We are pleased with this initial trajectory and on track to onboard more than 260 new offloaders by the end of the third quarter. Additionally, we are partnering with these offices on a waiting room promotional campaign to educate patients about the economy. We're also gathering market research information from these offices to help them bolster their practice satisfaction scores and provide better care for their patients.

Speaker Change: Now that the hiring and training of our sales force is complete, and we have satisfied licensing requirements in states covering over two-thirds of the U.S. population, we are promoting MidCombie in earnest.

Michael Rowe: This was up from approximately eight offices three months earlier. Many of those customers will see on our social media channels sharing their positive experiences with the product. We are pleased with this initial trajectory and on track to onboard more than 260 new offices by the end of the third quarter. Additionally, we are partnering with these offices on a waiting room promotional campaign to educate patients about the economy. We're also gathering market research information from these offices to help them bolster their practice satisfaction scores and provide better care for their patients.

Speaker Change: As of June 30th, we had trained and converted 63 offices.

Speaker Change: This was up from approximately eight offices three months earlier. Many of those customers you'll see in our social media channels sharing their positive experiences with the product.

Speaker Change: We are pleased with this initial trajectory and on track to onboard more than 260 new offices.

Speaker Change: by the end of the third quarter. Additionally, we are partnering with these offices on a waiting room promotional campaign to afford patients about PICOMBI. We're also gathering market research information from these offices to help them bolster their practice satisfaction scores and better care for their patients.

Michael Rowe: Offices and institutions, including the University of California and premier buying groups like VisionSource, have selected MidCombie for several compelling reasons. Unlike traditional eye drops, Minkambi's spray delivers a precise amount of medication, making the dilation process cleaner and more efficient. Clinical studies have reported virtually no stinging, ensuring a comfortable experience for patients. Additionally, its hygienic design eliminates protruding tips, reducing the risk of cross

Michael Rowe: Offices and institutions, including the University of California and premier buying groups like Vision Source, have selected MidCombie for several compelling reasons. Unlike traditional eye drops, Minkambi's spray delivers a precise amount of medication, making the dilation process cleaner and more efficient. Clinical studies have reported virtually no stinging, ensuring a comfortable experience for patients.

Speaker Change: Offices and institutions, including the University of California and premier buying groups like VisionSource, have selected MidCombie for several compelling reasons.

Speaker Change: Unlike traditional eye drops, Mincombe's spray delivers precise amounts of medication, making the dilation process cleaner and more efficient.

Speaker Change: Clinical studies have reported virtually no stinging, ensuring a comfortable experience for patients. Its hygienic design eliminates protruding tips, reducing the risk of cross-contamination between patients.

Bren Kern: Moreover, MidCombie works reliably and quickly, setting it apart from other options. At this point, I'd like to turn the call over to our Chief Operations Officer, Bren Kern, for our manufacturing update.

Bren Kern: Its hygienic design eliminates protruding tips, reducing the risk of cross-contamination between patients. Moreover, MidCombie works reliably and quickly, setting it apart from other options. At this point, I'd like to turn the call over to our Chief Operating Officer, Bren Kern, for our manufacturing update.

Speaker Change: Moreover, MidCombie works reliably and quickly, setting it apart from other options.

Speaker Change: At this point, I'd like to turn the call over to our Chief Operating Officer, Bren Kern, for our manufacturing update. Bren?

Bren Kern: Thanks, Michael. Our engineering, manufacturing, quality, and regulatory teams have been focusing on bringing our Advanced Gen 2 OptiJet device to the market. As a reminder, our Gen 2 platform offers the same performance as our first-generation platform but simplifies the user experience by utilizing motor control actuation and a sleeker profile. This design has also been assessed for scalability, offering fewer production steps, thus bringing us closer to our cost of goods target. Additionally, the Gen 2 device is being designed for future enhancements, such as our digital monitoring program, OptiQ. Billing and finish operations for the Gen 2 platform are performed at our Redwood City Facility.

Bren Kern: Thanks, Michael. Our engineering, manufacturing, quality, and regulatory teams have been focusing on bringing our Advanced Gen 2 OptiJet device to the market. As a reminder, our Gen 2 platform offers the same performance as our first-generation platform but simplifies the user experience by utilizing motor control actuation and a sleeker profile. This design has also been assessed for scalability, offering fewer production steps, thus bringing us closer to our cost of goods target. Additionally, the Gen 2 device is being designed for future enhancements, such as our digital monitoring program, Opti-K. Fill and finish operations for the Gen2 platform are performed at a Redwood City facility.

Bren Kern: Thanks, Michael. Our engineering, manufacturing, quality, and regulatory teams have been focusing on bringing our Advanced Gen 2 OptiJet device to the market.

Bren Kern: As a reminder, our Gen 2 platform offers the same performance as our first-generation platform, but simplifies the user experience by utilizing motor control actuation and a sleeker profile.

Bren Kern: This design has also been assessed for scalability, offering fewer production steps, thus bringing us closer to our cost of goods targets.

Unknown Executive: Greetings. Welcome to Eyenovia's second quarter, 2024 earnings call. At this time, all participants aren't illicit only mode.

Bren Kern: Additionally, the Gen 2 device is being designed for future enhancements, such as our digital monitoring program, OptiCare.

Unknown Executive: A question and answer session will follow the formal presentation. If anyone's require operator assistance during the conference, please press star zero on your telephone keypad. Please note this conference is being recorded.

Bren Kern: Build and finish operations for the Gen 2 platform are performed at our Redwood City facility.

Bren Kern: Recently, the production team completed our fourth media fill with passing results, verifying the aseptic process and readying our systems to produce registration batches of MidCombi. The MidCombi bulk drug is scheduled to ship this week, where three manufacturing lots will subsequently be filled into the GEN2 device and evaluated in a 12-month stability study. The units that comprise the study are commonly referred to as registration batches as the results of these studies are used to prove the drug product remains stable within the container over an extended duration.

Bren Kern: Recently, the production team completed our fourth media fill with passing results, verifying the aseptic process and readying our systems to produce registration batches of MidCombi. The McCombie Bulk Drug is scheduled to ship this week, where three manufacturing lots will subsequently be filled into the Gen 2 device and evaluated in a 12-month stability study. The units that comprise the study are commonly referred to as registration batches as the results of these studies are used to prove the drug product remains stable within the container over an extended duration.

Bren Kern: Recently, the production team completed our fourth media fill with passing results.

Bren Kern: verifying the aseptic process and readying our systems to produce registration batches of MidCombi. The MidCombi bulk drug is scheduled to ship this week where three manufacturing lots will subsequently be filled into the Gen 2 device and evaluated in a 12-month stability study.

Eric Ribner: I would now like to turn the conference over to Eric Ribner, investor relations. Thank you, maybe in.

Eric Ribner: Good afternoon and welcome to Eyenovia's second quarter, 2024 earnings conference call and audio webcast. With me today, our Eyenovia's Chief Executive Officer, Michael Rowe, Chief Financial Officer, John Gandolfo, and Chief Operating Officer, Bren Kern. This afternoon, we issued a press release announcing financial results for the three months and the June 30th, 2024. We encourage everyone to read today's press release as well as I know via this quarterly report on form 10Q for the quarter ended June 30th, 2024, which was just filed with the SEC.

Unknown Executive: Good afternoon and welcome to Eyenovia's second quarter, 2024 earnings conference call and audio webcast.

Unknown Executive: With me today, our Eyenovia's Chief Executive Officer, Michael Rowe, Chief Financial Officer, John Gandolfo, and Chief Operating Officer, Bren Kern. This afternoon, we issued a press release announcing financial results for the three months and the June 30th, 2024. We encourage everyone to read today's press release as well as I know via this quarterly report on form 10Q for the quarter ended June 30th, 2024, which was just filed with the SEC. The company's press release and annual report are also available on our website at www.inovia.com.

Bren Kern: The units that comprise the study are commonly referred to as registration batches as the results of these studies are used to prove the drug product remains stable within the container over an extended duration. We anticipate the completion of manufacturing for the registration batches at the end of this year.

Bren Kern: We anticipate the completion of manufacturing for the registration batches at the end of this year. The data collected over the subsequent 12 months will then be submitted to the FDA for its review. Similarly, the Gen 2 device also needs to undergo functional testing to obtain FDA approval. On July 23rd of this year, we received feedback from the FDA regarding our Type C meeting request to discuss the qualification of the Gen 2 platform.

Bren Kern: The data collected over the subsequent 12 months will then be submitted to the FDA for its review.

Bren Kern: Similarly, the Gen 2 device also needs to undergo functional testing to obtain FDA approval. On July 23rd of this year, we received feedback from the FDA regarding our Type C meeting request to discuss the qualification of the Gen 2 platform.

Eric Ribner: The company's press release and annual report are also available on our website at www.inovia.com. In addition, this conference call is being webcasts on the company's website and will be archived and available for replay for future reference.

Bren Kern: The content of the Type C meeting included an extensive overview of the Gen 2 device qualification plans, covering each aspect of testing we intend to perform. The feedback from the FDA was largely in agreement with our plans, providing high confidence that when complete, the requirements of the FDA will be fully satisfied. Our engineering team is now detailing the associated protocols and scheduling applicable tests. We are targeting the completion of our first round of testing in early 2025.

Unknown Executive: In addition, this conference call is being webcasts on the company's website and will be archived and available for replay for future reference. Please note that on today's call, we will be discussing products, product concepts, and candidates, some of which have yet to receive FDA approval. Please also note that certain information discussed on the call today is covered under the Safe Harbor provisions of the Private Security's litigation reform act. We caution listeners that during the call, I know these management will be making forward-looking statements.

Bren Kern: Content of the Type C meeting included an extensive overview of the Gen 2 device qualification plans, covering each aspect of testing we intend to perform. The feedback from the FDA was largely in agreement with our plans, providing high confidence that when complete, the requirements of the FDA will be fully satisfied.

Bren Kern: The feedback from the FDA was largely in agreement with our plans, providing high confidence that when complete, the FDA requirements will be fully satisfied. Our engineering team is now detailing the associated protocols and scheduling applicable tests. We are targeting the completion of our first round of testing in early 2025. This provides ample time to complete the associated reports and FDA submission package on or before receiving the results of the aforementioned stability studies.

Eric Ribner: Please note that on today's call, we will be discussing products, product concepts, and candidates, some of which have yet to receive FDA approval. Please also note that certain information discussed on the call today is covered under the Safe Harbor provisions of the Private Security's litigation reform act. We caution listeners that during the call, I know these management will be making forward-looking statements. Actual results could differ materially from those dated or implied by these forward-looking statements due to risks and uncertainties associated with the company's business. These forward-looking statements are subject to a number of risks which are described in more detail in our quarterly form 10Q as well as our annual reports on form 10K.

Bren Kern: Our engineering team is now detailing the associated protocols and scheduling applicable tests.

Unknown Executive: Actual results could differ materially from those dated or implied by these forward-looking statements due to risks and uncertainties associated with the company's business. These forward-looking statements are subject to a number of risks which are described in more detail in our quarterly form 10Q as well as our annual reports on form 10K.

Bren Kern: This provides ample time to complete the associated reports and FDA submission package on or before receiving the results of the aforementioned stability studies. The work we are doing to qualify the Gen 2 McCombie platform provides us with a model that we're able to apply to other drugs. For instance, upon receiving FDA approval for the Gen 2 MidCombi, subsequent device testing will likely be limited to verifying key performance characteristics for the new drugs and or any new features we wish to incorporate. These tests comprise a minority of device testing, offering expediency for future platform qualifications. For example, the Gen 2 platform for Bicombi will incorporate features only necessary for office use.

Bren Kern: We are targeting the completion of our first round of testing in early 2025. This provides ample time to complete the associated reports and FDA submission package on or before receiving the results of the aforementioned stability studies.

Bren Kern: The work we are doing to qualify the Gen 2 McCombie platform provides us with a model that we're able to apply to other drug platforms. For instance, upon receiving FDA approval for the Gen 2 MidCombi, subsequent device testing will likely be limited to verifying key performance characteristics for the new drugs and or any new features we wish to incorporate. These tests comprise a minority of device testing, offering expediency for future platform qualifications. For example, the Gen 2 platform for Big Combi will incorporate features only necessary for office use.

Bren Kern: The work we are doing to qualify the Gen 2 Mekombi platform provides us with a model that we are able to apply to other drug platforms.

Eric Ribner: This conference call contains time-sensitive information that is accurate only as of the date of this live broadcast August 12th, 2024. I know via undertakes no obligation to revise or update any forward-looking statements to reflect events or circumstances after the date of this conference call, except as may be required by the applicable securities law.

Unknown Executive: This conference call contains time-sensitive information that is accurate only as of the date of this live broadcast August 12th, 2024. I know via undertakes no obligation to revise or update any forward-looking statements to reflect events or circumstances after the date of this conference call, except as may be required by the applicable securities law.

Bren Kern: For instance, upon receiving FDA approval for the Gen 2 MidCombi, subsequent device testing will likely be limited to verifying key performance characteristics for the new drugs and or any new features we wish to incorporate.

Bren Kern: These tests comprise a minority of device testing, offering expediency for future platform qualifications.

Bren Kern: For example, the Gen 2 platform for Big Combi will incorporate features only necessary for office use.

Michael Rowe: With that said, I'd like to turn the call over to Michael Row, our Novius Chief Executive Officer. Michael. Thank you, Eric.

Bren Kern: But for Micropime, we will add additional features such as the OptiCare digital compliance system and child safety lockout feature, enabling a more desirable home use platform. The engineering team need only to focus on these new features as the Macombie design has already provided a base platform from which to build upon. Additionally, this system enables us to best support potential licensing partners in nutrient applications such as dry ice. As mentioned by Michael, our manufacturing team performed still-in-fission activities for SGN's Phase III-ready ophthalmic cyclosporine formulation, SG-101, at the end of July.

Bren Kern: But for Micropine, we will add additional features such as the OptiCare digital compliance system and child safety lockout feature, enabling a more desirable home use platform. The engineering team need only to focus on these new features as the Macombie design has already provided a base platform from which to build upon. Additionally, this system enables us to best support potential licensing partners in new treatment applications such as dry eye. As mentioned by Michael, our manufacturing team performed still-in-fishing activities for SGN's Phase III-ready ophthalmic cyclosporine formulation, SG-101, at the end of July.

Bren Kern: But for Micropyme, we will add additional features such as the OptiCare digital compliance system and child safety lockout feature, enabling a more desirable home use platform.

Michael Rowe: We welcome you to our second quarter of 2024 financial results conference call. During the second quarter, we advanced several initiatives that we discussed previously that are designed to strengthen the inherent value of binovia. These include our novel opt-ajet dispensing technology which we recently bought into three dry collaboration agreements of significant midterm potential value. Two FDA approved products, mid-combian COVID-as-all, and Micropind. Micropind is the only drug-device combination therapy in late phase three development for use in pediatric progressive myopia and is rapidly approaching a pivotal data readout.

Bren Kern: The engineering team need only to focus on these new features, as the McCombie design has already provided base platforms from which to build upon.

Bren Kern: Additionally, this system enables us to best support potential licensing partners in new treatment applications such as dry eye.

Michael Rowe: As mentioned by Michael, our manufacturing team performs still-in-fishing activities for SGN's Phase III-ready ophthalmic cyclosporine formulation, SG-101, at the end of July.

Bren Kern: Eyenovia and SDN will now collaborate to discuss the next steps, which may include a preliminary stability evaluation or additional device-related testing. Our model for evaluating new drugs begins with a small sprayability study utilizing our first generation device to assess delivery volume. This preliminary assessment is short in duration, typically less than a month, and provides Eyenovia and any potential partner with confidence about drug delivery performance in the OptiJet platform. With this hurdle cleared, we can then begin discussing manufacturing the product and conducting appropriate engineering tests.

Speaker Change: Inovia and SDN will now collaborate to discuss on the next steps which may include a preliminary stability evaluation or additional device related testing.

Michael Rowe: At I know via, our vision is to enhance yours by making topical ophthalmic therapies easier to use and easier to live with by addressing a broad range of patient and I care practitioner needs with novel technologies and products that are designed to be user friendly.

Speaker Change: Our model for evaluating new drugs begins with a small sprayability study utilizing our first-generation device to assess delivery volume.

Bren Kern: This preliminary assessment is short in duration, typically less than a month, and provides Eyenovia and any potential partner with confidence about drug delivery performance in the OptiJet platform. With this hurdle cleared, we can then begin discussing manufacturing the product and conducting appropriate engineering tests. In the case of SGM, this included fill-and-finish operations for cyclosporine in the second-generation platform. The collaborative and progressive nature of testing ensures critical aspects associated with introducing a new drug into the OptiJet platform are properly developed before engaging in a full platform. These types of details are covered in the development agreements we establish with each potential licensing partner.

Speaker Change: This preliminary assessment is short in duration, typically less than a month, and provides Inovia and any potential partner with confidence about drug delivery performance in the OptiJet platform. With this hurdle cleared, we then begin discussing manufacturing the product and conducting appropriate engineering tests. For more information on OptiJet, please visit www.optijet.com or call 1-877-433-6483.

Michael Rowe: We believe we are building a strong foundation for accelerating value creation in 2025 and beyond.

Bren Kern: In the case of SGM, this included fill-and-finish operations for cyclosporine in the second-generation platform. The collaborative and progressive nature of testing ensures critical aspects associated with introducing a new drug into the OptiJet platform are properly developed before engaging in a full platform. These types of details are covered in the development agreements we establish with each potential licensing partner.

Michael Rowe: I would like to begin this afternoon with an update on MicroPine, our drug device combination of Lodos Atradyn, administered with our proprietary optogen dispenser. This regimen is being developed as a potential treatment for progressive myopia in children. Recall that MicroPine is currently being evaluated in the ongoing late-says 3-shaperone study. Pediatric progressive myopia is increasingly recognized as an epidemic in both the United States and China. Pediatric myopia is a condition in which the eye abnormally elongates, putting children at risk of losing functional vision and can potentially result in severe retinal complications.

Speaker Change: In the case of SGM, this included fill and finish operations for cyclosporine in the second generation platform.

Speaker Change: The collaborative and progressive nature of testing ensures critical aspects associated with introducing a new drug into the OptiJet platform are properly developed before engaging in a full platform.

Speaker Change: These types of details are covered in the development agreements we establish with each potential licensing partner.

Bren Kern: While all of this is going on, we are also still just beginning to commercialize our first oxygen-based product, MidCombi. Production continues to progress as planned, and as a reminder, earlier this year, our Redwood City facility was approved by the FDA to conduct final assembly, labeling, and packaging of midcombing in our Gen 1 platform. This addition, coupled with the capabilities of our CMO and our RENA facility, provides synergies in manufacturing by allowing it to occur in relatively close proximity and within the same time zone.

Bren Kern: While all of this is going on, we are also still just beginning to commercialize our first oxygen-based product, MidCombi. Production continues to progress as planned, and as a reminder, earlier this year, our Redwood City facility was approved by the FDA to conduct final assembly, labeling, and packaging of MCOMBI in our Gen 1 platform. This addition, coupled with the capabilities of our CMO and our RENA facility, provides synergies in manufacturing by allowing it to occur in relatively close proximity and within the same time zone.

Speaker Change: While all of this is going on, we are also still just beginning to commercialize our first oxygen-based product, MidCombi.

Speaker Change: Production continues to progress as planned and as a reminder earlier this year our Redwood City facility was approved by the FDA to conduct final assembly, labeling, and packaging of McCombie in our Gen 1 platform.

Michael Rowe: In the US alone of nearly 20 million children with myopia, approximately 5 million are considered at risk of losing functional vision due to this disease. Additionally, the rights to MicroPine have been licensed to arctic vision, our partner in China, who is conducting a clinical trial for submission to the Chinese authority. While glasses and contact lenses are the current standard of care for children diagnosed with myopia, they only slow disease progression, but do not cure the disease.

Speaker Change: This addition, coupled with the capabilities of our CMO and our RENO facility, provides synergies in manufacturing by allowing them to occur in relative close proximity and within the same time zone.

Bren Kern: This provides Eyenovia with greater control and scheduling flexibility, which we are leveraging to our advantage. Moving to Coletazole, our distribution systems have largely been established, and as a reminder, our Redwood City facility will serve as the distribution center. These preparations should enable the Eyenovia sales team, as well as our co-promotion partner NovaBay, to immediately begin selling upon receiving the Coletazole product. My enthusiasm for the activities, plans, and, most importantly, our future, has never been higher.

Bren Kern: This provides Eyenovia with greater control and scheduling flexibility, which we are leveraging to our advantage. Moving to Colectazole, our distribution systems have largely been established, and as a reminder, our Redwood City facility will serve as the distribution center. These preparations should enable the Eyenovia sales team, as well as our co-promotion partner, NovaBay, to immediately begin selling upon receiving the gluconazole products. My enthusiasm for the activities, plans, and, most importantly, our future, has never been higher.

Speaker Change: This provides Idenovia with greater control and scheduling flexibility, which we are leveraging to our advantage.

Speaker Change: Moving to Colette is all our distribution systems have largely been established and as a reminder our Redwood City facility will serve as the distribution center.

Michael Rowe: Current treatments are often not well-tolerated or appropriate for the youngest, most vulnerable patients who frequently struggle with discomfort and severe issues. Atropine has been shown in prior studies such as Lamp and Adam, the slow myopia progression by as much as 60%. And now with proprietary atropine formulation, administered with the octaget, may offer benefits far beyond what could be obtained with a traditional eye drop. With the octaget technology, children in the shaperone study, as young as 6 years old, are dosing themselves nightly with minimal parental supervision.

Speaker Change: These preparations should enable the Inovia sales team, as well as our co-promotion partner NovaBay, to immediately begin selling upon receiving Gluconazole products.

Speaker Change: My enthusiasm for the activities, plans, and most importantly, our future, has never been higher. We have an amazing delivery platform, incredible team, and have engaged with potential partners that can leverage the OptiJet platform in treatments to benefit those afflicted by debilitating eye disease.

Bren Kern: We have an amazing delivery platform, an incredible team, and have engaged with potential partners that can leverage the OptiJet platform in treatments to benefit those afflicted by debilitating eye disease. I would now like to turn the call over to our Chief Financial Officer, John Gandolfo.

John Gandolfo: We have an amazing delivery platform, an incredible team, and have engaged with potential partners that can leverage the OptiJet platform in treatments to benefit those afflicted by debilitating eye disease. I would now like to turn the call over to our Chief Financial Officer, John Gandolfo.

John Gandolfo: For the second quarter of 2024, we reported a net loss of approximately $11.1 million, or $0.21 per share on approximately 53.1 million weighted average shares outstanding. This includes a $0.05 loss related to the $2.9 million of costs for bringing micropime back to Eyenovia and a $0.02 gain included in other income from a change in fair value of equity consideration payable. This compares to a net loss of $6.2 million, or $0.16 per share, and approximately 38.1 million weighted average shares outstanding for the second quarter of 2023.

Speaker Change: I would now like to turn the call over to our Chief Financial Officer, John Gandolfo. John?

John Gandolfo: Thank you, Brian. For the second quarter of 2024, we reported a net loss of approximately $11.1 million, or $0.21 per share, on approximately 53.1 million weighted average shares outstanding. This includes a $0.05 loss related to the $2.9 million of costs for bringing micropime back to Eyenovia and a $0.02 gain included in other income from a change in fair value of equity consideration payable. This compares to a net loss of $6.2 million, or $0.16 per share, and approximately 38.1 million weighted average shares outstanding for the second quarter of 2023.

John Gandolfo: Research and development expenses totaled approximately $4.6 million for the second quarter of 2024, and this compares to $2.8 million for the first quarter of 2023, an increase of 64%. This increase is largely the result of expensing previously deferred clinical supplies, which was related to the reacquisition of the license rights from Bausch and Lowe. In addition, the company had increased internal engineering expenses related to the development of the Gen 2 OptiJet system. For the second quarter of 2024, G&A expenses were approximately $3.8 million as compared to $3.1 million for the second quarter of 2023, an increase of 19%.

John: Thank you, Bren.

Michael Rowe: They can self-administer the dose because the octaget doesn't require any health-head-telting or manipulation of an eye drop or bottle, making aiming with a built-in mirror and medication administration achievable. The children can see exactly where they are spraying medication and become familiar and comfortable with the dosing process quickly, which can reduce dosing anxiety and minimizes the number of struggles parents face with dosing children with conventional eye drops. The side effects of atropine dose with the octaget have been notably mild and transient from the shaperone study.

John Gandolfo: For the second quarter of 2024, we reported a net loss of approximately $11.1 million or $0.21 per share on approximately 53.1 million weighted average shares outstanding.

John Gandolfo: This includes a $0.05 loss related to the $2.9 million of costs for bringing microfine back to Inovia and a $0.02 gain included in other income from a change in fair value of equity consideration payable.

John Gandolfo: This compares to a net loss of $6.2 million, or $0.16 per share, and approximately 38.1 million weighted average shares outstanding for the second quarter of 2023.

Michael Rowe: These results are consistent with what we have come to expect with our advanced drug-device dosing system. Throughout the trial, we have been measuring the performance of the octaget with an embedded firmware that allows study doctors to better understand how and when the device has been used. Each time the dosing button is pressed to administer medication, the device records the event and stores the information. This information can be accessed and reviewed by the clinic staff during visits from the study.

John Gandolfo: This increase is largely the result of expensing previously deferred clinical supplies, and this was related to the reacquisition of the license rights from Bausch & Lomb.

Michael Rowe: For the commercial product, we anticipate micro-pine will be equipped with our optical care system, which can notify patients and their parents when to administer their sprayed dose, as well as communicate important compliance of the hearing's information to the treatment position. Our engineers are working today on plans to validate the system for FDA approval. We are continuing to advance the phase three shaperone study and are planning for an efficacy analysis in the fourth quarter of this year.

John Gandolfo: In addition, the company had increased internal engineering expenses related to the development of the Gen 2 Opti-Jet system.

John Gandolfo: For the second quarter of 2024, G&A expenses were approximately $3.8 million as compared to $3.1 million for the second quarter of 2023, an increase of 19%. This increase was comprised of a $374,000 increase in salaries and benefits, primarily related to the hiring of our internal sales force for the start of the company's commercialization efforts, as well as $255,000 related to non-recovering FDA funding. Total operating expenses for the second quarter of 2024 were approximately $11.2 million, including the previously mentioned $2.9 million in repatriation costs for bringing Microbead back to Eyenovia, and this compares to $6 million for the same period of 2023. This represents an increase of approximately 88%.

John Gandolfo: For the second quarter of 2024, G&A expenses were approximately $3.8 million as compared to $3.1 million for the second quarter of 2023, an increase of 19 percent.

John Gandolfo: This increase was comprised of a $374,000 increase in salaries and benefits.

John Gandolfo: primarily related to the hiring of our internal sales force for the start of the company's commercialization efforts, as well as $255,000 related to a non-recurring FDA fee.

Michael Rowe: One states statistically sufficient number of patients have reached the study efficacy end point. If the results are positive, this would significantly de-risk the program and potentially enable an NDA submission as soon as late 2025 or early 2026. Recall that the FDA has agreed that a properly conducted single phase three study could be sufficient for an NDA filing and approval. As we have mentioned before, we believe this program would then present a very attractive opportunity for commercialization either by us or a large reporter.

John Gandolfo: This increase was comprised of a $374,000 increase in salaries and benefits, primarily related to the hiring of our internal sales force for the start of the company's commercialization efforts, as well as $255,000 related to a non-recurring FDA inspection. Total operating expenses for the second quarter of 2024 were approximately $11.2 million, including the previously mentioned $2.9 million in repatriation costs for bringing Microbead back to Eyenovia, and this This represents an increase of approximately 88%. Our second quarter 2024 operating expense figure included approximately $3.8 million of non-cash expenses.

John Gandolfo: Our second quarter 2024 operating expense figure included approximately $3.8 million of non-cash expenses. At June 30, 2024, we reported unrestricted cash of approximately $2.3 million. This excludes approximately $5.8 million of capital that was raised after June 30, 2024.

John Gandolfo: This represents an increase of approximately 88%. Our second quarter 2024 operating expense figure included approximately $3.8 million of non-cash expenses.

Michael Rowe: Turning now to dry eyes since our last quarterly update, we have executed three collaboration agreements that leverage our op-to-jet dispenser for dry eye. Symptoms of dry eye can significantly interfere with daily life, leaving many patients unsatisfied with currently available therapies. According to our recent survey, while 48% of patients reported carefully following their treatment plans, only 13% experienced lasting relief.

John Gandolfo: At June 30, 2024, we reported unrestricted cash of approximately $2.3 million. This excludes approximately $5.8 million of capital that was raised after June 30, 2024. In addition to the current resources that we have available, the company is currently evaluating a wide range of capital raising structures and initiatives in order to fund our ongoing strategy. In addition, we will continue to look at ways to improve our operating efficiencies and potentially reduce operating expenses going forward.

John Gandolfo: At June 30, 2024, we reported unrestricted cash of approximately $2.3 million. This excludes approximately $5.8 million of capital that was raised after June 30, 2024.

John Gandolfo: In addition to the current resources that we have available, the company is currently evaluating a wide range of capital raising structures and initiatives in order to fund our ongoing strategy. In addition, we will continue to look at ways to improve our operating efficiencies and potentially reduce operating expenses going forward. I'll now provide an update on our existing licensing programs with Arctic Vision, which covers all three of our products in China and South Korea, Micropine, Microline, as well as McCombie, and provides us with sales royalties in addition to development milestones. Micropine, in particular, is a significant opportunity in China for pediatric myopia.

Michael Rowe: Nearly 16 million of our staff suffer from dry eye with treatment expenditures totaling over $3 billion in the U.S, and $5 billion globally. Beginning with Formosa, we recently announced that we signed an agreement to develop a formulation of flowbeds all in the op-to-jet as a potential treatment for acute dry eye. This development program, which would require two 15-day clinical trials, would be free of any upfront fees from I knowviya or development milestones to Formosa until the product is FDA approved. This is an ideal extension of our existing relationship with Formosa and demonstrates how we can extend the use of an eye drop formulation through incorporation of the op-to-jet.

John Gandolfo: In addition, we will continue to look at ways to improve our operating efficiencies and potentially reduce operating expenses going forward.

John Gandolfo: I'll now provide an update on our existing licensing programs with Arctic Vision, which covers all three of our products in China and South Korea, Micropine, Microlign, as well as Maccabi, and provides us sales royalties in addition to development milestones. Micropine in particular is a significant opportunity in China for pediatric myopia.

John Gandolfo: I'll now provide an update on our existing licensing programs with Arctic Vision, which covers all three of our products in China and South Korea.

John Gandolfo: Micropine, Microlign, as well as Maccabi, and provides us sales royalties in addition to development milestones.

Speaker Change: Micropine in particular is a significant opportunity in China for pediatric myopia. If approved, Micropine could be a potentially meaningful source of non-diluted funding for our company over the long term.

John Gandolfo: If approved, Micropine could be a potentially meaningful source of non-dilutive funding for our company over the long term. To date, our license agreements have generated approximately $16 million in license fees, and we have the potential to earn an additional $25 million in net license and development milestones from Arctic Vision over the next three to four years. Included in this amount is approximately $1.5 million to $2 million expected to be received over the next six to nine months.

Michael Rowe: We also recently signed the collaboration agreement with Senju Pharmaceutical to develop a new and chumped treatment for chronic dry eye disease. For the terms of that agreement, we will jointly work to develop Senju's epithelial woof healing candidate, SJP35, for use with our op-to-jet dispenser. This potential drug device combination is unique because it would be designed for use alongside other dry eye medications. In other words, it complements existing products rather than competing with them.

Speaker Change: To date, our license agreements have generated approximately $16 million in license fees, and we have the potential to earn an additional $25 million in net license and development milestones from Arctic Vision over the next three to four years.

Speaker Change: Included in this amount is approximately 1.5 million to 2 million dollars expected to be received over the next six to nine months.

John Gandolfo: As I said previously, if our products are approved, upon commercialization, Eyenovia is also eligible to earn significant sales royalties. We are continuing to assess potential pipeline expansion opportunities similar to our Formosa, Senju, and SGN agreements, and we will continue to leverage the OptiJet technology to address unmet needs and additional large optimic indications, beginning with dry ice. As Michael indicated earlier, we believe the steps we have taken to date create a solid foundation for which to drive meaningful sales growth in 2025 and beyond.

John Gandolfo: As I said previously, if our products are approved, upon commercialization, Eyenovia is also eligible to earn significant sales royalties. We are continuing to assess potential pipeline expansion opportunities similar to our FRMOSA, CENGIEW, and SGN agreements, and we will continue to leverage the OptiJet technology to address unmet needs and additional large ophthalmic indications, beginning with dry eye. As Michael indicated earlier, we believe the steps we have taken to date create a solid foundation for which to drive meaningful sales growth in 2025 and beyond.

Speaker Change: As I said previously, if our products are approved, upon commercialization Inovia is also eligible to earn significant sales royalties.

Michael Rowe: We are working towards a meeting with the FDA Labor this year, followed by completion of a Phase II B study in 2025. If successful, the companies will expand this collaboration to initiate two Phase III studies by 2026. SJP35 has been shown to be well-tolerated in prior Phase II and Phase II studies as a standard eye drop tested at multiple doses in over 250 subjects.

Speaker Change: We are continuing to assess potential pipeline expansion opportunities similar to our PROMOSA, CENGIEW, and SGN agreements, and we will continue to leverage the OptiJet technology to address unmet needs and additional large ophthalmic indications, beginning with dry eye.

Speaker Change: As Michael indicated earlier, we believe the steps we have taken to date create a solid foundation for which to drive meaningful sales growth in 2025 and beyond.

Michael Rowe: And continuing on with the topic of dry eye in late February, we enter into a collaboration agreement with SGN Nanoharma, an innovation-led clinical stage nanoharmaceutical company focused on creating compactal, best-in-class nanotherapeutics targeting large, unmet medical needs. SGN's proprietary micellular nanoparticle platform allows for the distribution of an active pharmaceutical ingredient into three or more phases, thereby improving its bioavailability, bio-distribution and pharmacokinetics. For the term of the agreement, I know via has been conducting feasibility at process manufacturing testing with SGN Phase III ready to sound like this foreign formulation, SGN 101, in combination with our Gen-2 out-to-get device as a potential treatment for product dry eye.

John Gandolfo: In conclusion, we are very pleased with our performance in the second quarter of 2024 and summarize our key highlights today. We are preparing for a full analysis of data from our ongoing Phase III chaperone trial of micropine and pediatric progressive myelopia, which, if positive, would allow us to significantly advance its remaining development timeline. We entered into development and collaborations with Formosa, Senju, and SGN to develop novel therapeutic formulations for the OptiJet that would potentially address unmet needs in acute and chronic dry eyes.

John Gandolfo: In conclusion, we are very pleased with our performance in the second quarter of 2024 and summarize our key highlights today. We are preparing for a full analysis of data from our ongoing Phase III chaperone trial of micropine and pediatric progressive myelopia, which, if positive, would allow us to significantly advance its remaining development timeline. We entered into development and collaboration agreements with Formosa, Senju, and SGN to develop novel therapeutic formulations for the OptiJet that would potentially address unmet needs in acute and chronic dry eyes. Additionally, we entered into a co-promotion agreement with Novavay Pharmaceuticals, whereby Novavay will market clabetasol through its U.S.

Michael Rowe: In conclusion, we are very pleased with our performance in the second quarter of 2024.

Michael Rowe: and summarize our key highlights today.

Speaker Change: We are preparing for a full analysis of data from our ongoing Phase 3 chaperone trial of micropine and pediatric progressive myelopia, which, if positive, would allow us to significantly advance its remaining development timelines.

Speaker Change: We entered into development and collaborations with Formosa, Senju, and SGN to develop novel therapeutic formulations for the OptiJet that would potentially address unmet needs in acute chronic dry eye disease.

John Gandolfo: Physician Dispense Channel, and the agreement also gives us access to their prescription Avanova antimicrobial lead-enlash solution, which complements our commercial product. Our commercial launch of McCombie continues to track well, with the product now in use at over 63 ophthalmology offices around the country and tracking to more than 260 by the end of the third quarter. And finally, our license agreement with Arctic Vision is progressing well and remains a promising avenue for significant development and regulatory milestones, as well as the potential for sales royalties. That concludes our prepared remarks; we would now like to open the call to questions. Operator.

John Gandolfo: We entered into a co-promotion agreement with Novavay Pharmaceuticals, whereby Novavay will market Clabetasol through its U.S. Physician Dispense Channel, and the agreement also gives us access to their prescription abinova antimicrobial lead and lash solution, which complements our commercial product. Our commercial launch of McCombie continues to track well, with the product now in use at over 63 ophthalmology offices around the country and tracking to more than 260 by the end of the third quarter.

Speaker Change: We entered into a co-promotion agreement with Novavay Pharmaceuticals, whereby Novavay will market glabetosol through its U.S. physician dispense channel.

Michael Rowe: A combination of a faster working cyclist's foreign than the OptiJet could be a powerful new treatment option for this large and undeserved, underserved market. With the SGN collaboration, we may have this face-free ready asset next year in chronic dry-eye. With these three agreements, we can potentially cover the entire dry-eye market, which is a $3 billion annual addressable market in the United States with a multi-million patient population and significant unmet needs. We anticipate achieving this through an acute product for flare-ups with Formosa, an adjunctive chronic medication with Sendu, and a chronic medication with SGN.

Speaker Change: And the agreement also gives us access to their prescription Abinova antimicrobial lid and lash solution, which complements our commercial products.

Speaker Change: Our commercial launch of McCombie continues to track well, with the product now in use at over 63 ophthalmology offices around the country, and tracking to more than 260 by the end of the third quarter.

John Gandolfo: And finally, our license agreement with Arctic Vision is progressing well and remains a promising avenue for significant development and regulatory milestones, as well as the potential for sales royalties. That concludes our prepared remarks. We would now like to open the call to questions.

Speaker Change: And finally, our license agreement with Arctic Vision is progressing well and remains a promising avenue for significant development and regulatory milestones, as well as the potential for sales royalties.

Michael Rowe: Now I'd like to discuss COVID-asol. The FDA approved COVID-asol on March 4th and shortly after the new drug application or NDA for this product was transferred to us from Formosa. COVID-asol is the first new ophthalmic steroid approved in the U.S, over 15 years. Well, that has all addresses many unmet needs in ophthalmic steroids with its highly differentiated clinical and pharmacologic profile. It offers twice daily dosing, then from a safety perspective, fewer than 1% of patients experience sudden eye pressure increases, which may be more common with other steroids. Intra-ocular inflammation and eye pressure spikes for the primary safety concerns for eye surgeons.

Michael Rowe: Now I'd like to discuss COVID-asol. The FDA approved COVID-asol on March 4th and shortly after the new drug application or NDA for this product was transferred to us from Formosa.

Speaker Change: That concludes our prepared remarks. We would now like to open the call to questions.

Operator: Thank you. If you would like to ask a question, please press star one on your telephone keypad. A confirmation tone will indicate your line is in the question queue. You may press star two if you would like to remove your question from the queue. For participants using speaker equipment, it may be necessary to pick up your handset before pressing the star keys.

Operator: And for participants using speaker equipment, it may be necessary to pick up your handset before pressing the star keys. One moment while we poll for questions. Our first question is from Matt Kaplan with Lattinburg-Foundland. Please proceed.

Speaker Change: Operator

Speaker Change: Thank you. If you would like to ask a question, please press star 1 on your telephone keypad. A confirmation tone will indicate your line is in the question queue.

Michael Rowe: COVID-asol is the first new ophthalmic steroid approved in the U.S, over 15 years. Well, that has all addresses many unmet needs in ophthalmic steroids with its highly differentiated clinical and pharmacologic profile. It offers twice daily dosing, then from a safety perspective, fewer than 1% of patients experience sudden eye pressure increases, which may be more common with other steroids. Intra-ocular inflammation and eye pressure spikes for the primary safety concerns for eye surgeons. As they can lead to serious clinical consequences, complications, and non-reimbursable costs for providers, we believe that COVID-asol has the potential to become the leading option in the post-surgical space.

Speaker Change: You may press star 2 if you would like to remove your question from the queue. And for participants using speaker equipment, it may be necessary to pick up your handset before pressing the star keys. One moment while we poll for questions.

Operator: One moment while we poll for questions. Our first question is from Matt Kaplan with Lattinburg-Foundland. Please proceed.

Speaker Change: Our first question is from Matt Kaplan with Lattinburg-Foundland. Please proceed.

Matthew Kaplan: Hey guys, thanks for taking my question. Just can you give us a little bit more detail in terms of the path to the regulatory filing for micropine, assuming a positive outcome of the chaperone analysis expected in the near term in the fourth quarter, and then also kind of in that vein, talk about the evolving competitive landscape for micropine and micropine and how it can be, how it can differentiate, and when it comes.

Matthew Kaplan: Hey, guys, thanks for taking my question. Just can you give us a little bit more detail in terms of the path to the regulatory filing for micropine, assuming a positive outcome of the chaperone analysis expected in the near term in the fourth quarter? And then also, kind of in that vein, talk about the evolving competitive landscape for micropine and micropene and how it can be, how it can differentiate, and when it comes. Thank you, Matt.

Matt Kaplan: Hey guys, thanks for taking my question.

Michael Rowe: As they can lead to serious clinical consequences, complications, and non-reimbursable costs for providers, we believe that COVID-asol has the potential to become the leading option in the post-surgical space. This unique steroid is the first product developed using Promosis proprietary APNT nanoparticle formulation platform. Patients do not have to shake the product prior to use, and that is just one of the unique elements of our pre-level. While that may seem minor, it highlights the key difference between obevisol and other ophthalmic steroids.

Speaker Change: Can you give us a little bit more detail in terms of the...

Speaker Change: pass to the regulatory filing for Micropyme.

Speaker Change: Assuming a positive outcome of the chaperone analysis expected in the near term in the fourth quarter.

Michael Rowe: This unique steroid is the first product developed using Promosis proprietary APNT nanoparticle formulation platform. Patients do not have to shake the product prior to use, and that is just one of the unique elements of our pre-level. While that may seem minor, it highlights the key difference between obevisol and other ophthalmic steroids. Obevisol's efficacy and its previously discussed safety profile further set of the part. In clinical results, nearly 9 out of 10 patients experience complete relief from post-surgical pain, and 60% had total resolution of inflammation within 15 days after ocular surgery, with all side effects occurring in less than 2% of cases.

Speaker Change: and then also kind of in that, in that vein.

Speaker Change: Talk about the, also talk about the evolving competitive landscape.

Speaker Change: for micropine and micropene and how.

Speaker Change: It can be how it can differentiate.

Michael Rowe: Thank you, Matt. The regulatory pathway would be after looking at the efficacy data, we would request a meeting with the FDA. The earliest we would probably get that meeting is the beginning of 2025, 75 days after we asked for it. The FDA would review the efficacy data. Assuming that goes well, there's also a commitment for one year of additional safety. That would be up in about September or October of 2025.

Speaker Change: and, and, and, and,

Michael Rowe: The regulatory pathway would be after looking at the efficacy data, we would request a meeting with the FDA. The earliest we would probably get that meeting is the beginning of 2025, 75 days after we asked for it. The FDA would review the efficacy data. Assuming that goes well, there's also a commitment for one year of additional safety. That would be up in about September or October of 2025.

Speaker Change: when it comes to market.

Michael Rowe: Obevisol's efficacy and its previously discussed safety profile further set of the part. In clinical results, nearly 9 out of 10 patients experience complete relief from post-surgical pain, and 60% had total resolution of inflammation within 15 days after ocular surgery, with all side effects occurring in less than 2% of cases. Moreover, twice daily dosing, without the need for titration, is a clear advantage, especially compared to treatments requiring up to four doses a day.

Matt Kaplan: Thank you, Matt.

Matt Kaplan: The regulatory pathway would be after looking at the efficacy data, we would request a meeting with the FDA.

Speaker Change: The earliest we would probably get that meeting is the beginning of 2025, 75 days after we asked for it.

Speaker Change: for the FDA to review the efficacy data. Assuming that goes well, there's also a commitment for one year of additional safety. That would be up in about September, October of 2025.

Michael Rowe: Moreover, twice daily dosing, without the need for titration, is a clear advantage, especially compared to treatments requiring up to four doses a day. This simplicity is particularly valuable for eye surgery patients who often use multiple medications during recovery. Both eye doctors and patients will appreciate this advancement, which may simplify the treatment of regimen.

Michael Rowe: So when that is done, we will be able to submit the full efficacy and safety information. At the same time, we plan to make registration batches of Micropine beginning the end of this year so that by the end of 2025, we would have the efficacy, the safety, and the stability data ready for that NDA submission, and that's why we're saying the end of 2025 and early 2026, and then there would be a 10-month review, which would take you to the middle back half of 2026 for approval. In terms of the competitive landscape, there's only one other product that we are aware of that's in late-stage development for this, and that product is similarly a low-dose atropine, but it's an eye drop.

Michael Rowe: So when that is done, we will be able to submit the full efficacy and safety information. At the same time, we plan to make registration batches of micropine beginning the end of this year so that by the end of 2025, we will have the efficacy, the safety, and the stability data ready for that NDA submission. And that's why we're saying the end of 2025 and early 2026. And then there would be a 10-month review, which would take you to the middle back half of 2026 for approval. In terms of the competitive landscape, there's only one other product that we are aware of that's in late-stage development for this, and that product is similarly a low-dose atropine, but it's an eyedrop.

Michael Rowe: This simplicity is particularly valuable for eye surgery patients who often use multiple medications during recovery. Both eye doctors and patients will appreciate this advancement, which may simplify the treatment of regimen. It is estimated that more than 7 million off-year surgeries were performed annually in the U.S, with cocktail ocular steroids, and steroid combinations currently generating 1.3 billion in sales. This represents a significant market opportunity. We believe we can capture a mid-single-digit market share over the next three or four years as previously mentioned.

Speaker Change: So when that is done, we would be able to submit the full efficacy and safety information.

Speaker Change: At the same time, we plan to make registration batches of micropine.

Michael Rowe: It is estimated that more than 7 million off-year surgeries were performed annually in the U.S, with cocktail ocular steroids, and steroid combinations currently generating 1.3 billion in sales. This represents a significant market opportunity. We believe we can capture a mid-single-digit market share over the next three or four years as previously mentioned. Our 10 sales representatives, who we began hiring over the last few months, and completed their training just two weeks ago, are today pre-qualifying eye surgery offices for their interest in Kuwaitazol.

Speaker Change: beginning the end of this year so that by the end of 2025 we would have the efficacy, the safety, and the stability data are ready for that NDA submission and that's why we're saying the end of 2025, early 2026.

Speaker Change: and then would be a 10-month review, which would take you to the middle back half of 2026 for an approval.

Michael Rowe: Our 10 sales representatives, who we began hiring over the last few months, and completed their training just two weeks ago, are today pre-qualifying eye surgery offices for their interest in Kuwaitazol. Each representative or T-account manager aims to set your 50 offices of preparation for the product launch in the United States. This approach will allow us to hit the ground running and build a positive early success. We had previously communicated that we were planning on a commercial launch this summer, which would be supplemented by our co-promotion agreement with Nova Bay Pharmaceuticals.

Speaker Change: In terms of the competitive landscape, there's only one other product that we are aware of.

Speaker Change: that's in late-stage development for this and that product is similarly a low-dose atropine but it's an eye drop and we think there's a tremendous difference between using an eye drop in pediatrics and being able to use the OptiJet.

Michael Rowe: And we think there's a tremendous difference between using an eyedrop in pediatrics and being able to use the OptiJet. With the OptiJet, as I mentioned, the kids are doing this themselves, and they have to do it every night. They brush their teeth, they spray their eyes, and go to bed, but they have to do it for three years at least to get the full benefit of the product. So this is something that, as a parent myself, I have difficulty imagining having to do that every night with my children and knowing how much they would enjoy having eyedrops put in their eyes.

Michael Rowe: And we think there's a tremendous difference between using an eye drop in pediatrics and being able to use the OptiJet. With the OptiJet, as I mentioned, the kids are doing this themselves, and they have to do it every night. They brush their teeth, they spray their eyes, and go to bed, but they have to do it for three years, at least, to get the full benefit of the product. So this is something that, as a parent myself, I have difficulty imagining having to do that every night with my children and knowing how much they would enjoy having eye drops put in their eyes.

Michael Rowe: Each representative or T-account manager aims to set your 50 offices of preparation for the product launch in the United States. This approach will allow us to hit the ground running and build a positive early success. We had previously communicated that we were planning on a commercial launch this summer, which would be supplemented by our co-promotion agreement with Nova Bay Pharmaceuticals. This is still our intent as we await the product arriving here from Formosa.

Speaker Change: With the OptiJet, as I mentioned, the kids are doing this themselves, and they have to do it every night. They brush their teeth, they spray their eyes.

Speaker Change: and go to bed, but they have to do it for three years.

Speaker Change: at least to get the full benefit of the product. So this is something that I just, as a parent myself, I have difficulty imagining me having to do that every night.

Michael Rowe: This is still our intent as we await the product arriving here from Formosa. In the meantime, we have expanded our promotional arrangement with Nova Bay to include additional products already used by our core customers, enabling our Salesforce to upgrade efficiently while they set the stage for what we believe will be a game-changer and an ocular steroid treatment.

Michael Rowe: In the meantime, we have expanded our promotional arrangement with Nova Bay to include additional products already used by our core customers, enabling our Salesforce to upgrade efficiently while they set the stage for what we believe will be a game-changer and an ocular steroid treatment.

Michael Rowe: Also, our product, at least from what we're seeing in the mask data, is very well-tolerated, which is not a surprise, given the OptiJet uses a lower volume of medication. And inherent with that lower volume of medication, you're also getting less systemic exposure to the active ingredient, which when you're talking about pediatrics, you have small people using a drug over many years, and you wanna minimize that as much And then lastly, you have all the benefits of the electronic optic care system, which means that parents and kids and their doctors can see what's going on because if you don't use the medication, you don't get the benefit.

Speaker Change: with my children and knowing how much they would enjoy having eyedrops put in their eyes.

Michael Rowe: Also, our product, at least from what we're seeing in the mask data, is very well tolerated, which is not a surprise given the OptiJet uses a lower volume of medication. And inherent in that lower volume of medication, you're also getting less systemic exposure to the active ingredient, which when you're talking about pediatrics, you have small people using a drug over many years, and you want to minimize that as much as possible.

Speaker Change: Also, our product, at least from what we're seeing in the mask data, is very well tolerated, which is not a surprise given the OptiJet uses a lower volume.

Michael Rowe: Now, we'll provide enough data on mid-convy.

Speaker Change: of Medication. And inherent with that lower volume of medication, you're also getting less systemic exposure to the active ingredient, which when you're talking about pediatrics, you have small people using a drug over many years, and you wanna minimize that as much as possible.

Michael Rowe: It is the first and only FDA-approved fixed combination of two well-known pupil dilation drugs to pick amythininelephrine, and the first approved of phalmic spray using the OptiGeth platform. Now that the hiring and training of our Salesforce is complete, and we have satisfied licensing requirements in states covering over two-thirds of the U.S, population. We are promoting mid-convy in earnest. As of June 30th, we had trained and included 63 offices. This was up approximately from approximately eight offices three months earlier.

Michael Rowe: And then lastly, you have all the benefits of the electronic optic care system, which means that parents and kids and their doctors can see what's going on. Because if you don't use the medication, you don't get the benefit. And we want to make sure that everybody gets that benefit, and we have seen from the initial compliance data that kids are using it more often and more regularly than one would expect from an eye drop. So I think, you know, competitively, competitively, we'll be in a very good place because of the marriage between the drug and the OptiJet system. Okay, that's really helpful.

Speaker Change: And then lastly, you have all the benefits of the electronic optic care system, which means that parents and the kids and their doctors

Michael Rowe: And we want to make sure that everybody gets that benefit, and we have seen from the initial compliance data that kids are using it more often and more regularly than one would expect from an eye drop. So I think, you know, competitively, we'll be in a very good place because of the marriage between the drug and the OptiJet system.

Speaker Change: and see what's going on, because if you don't use the medication, you don't get the benefit.

Speaker Change: And we want to make sure that everybody gets that benefit. And we have seen from the initial compliance data that the kids are using it more often and more regularly than one would expect from an eye drop. So I think, you know, competitively, competitively we'll be in a very good place.

Michael Rowe: Many of those customers will see in our social media channel sharing their positive experiences with the product. We are pleased with this initial trajectory and on track to onboard more than 260 new offices by the end of the third order. Additionally, we are partnering with these offices on a waiting room commercial campaign to afford patients about mid-convy. We are also gathering market research information from these offices to help them bolster their practice satisfaction scores and better care for their patients.

Matthew Kaplan: Okay, that's really helpful. Thank you, Michael.

Speaker Change: because of the marriage between the drug and the OptiJet system.

Michael Rowe: And then, if I may, a couple more questions in terms of clobetazole. When do you think you'll be able to launch that? It seems like you've been delayed a little bit this summer. And when do you think you will be able to have that?

Speaker Change: Okay, that's really helpful. Thank you, Michael. And then, if I may, a couple more questions. In terms of clobetazole, when do you think you'll be able to launch that? It seems like you've been delayed a little bit this summer, and when do you think to be able to have that on the market?

Matthew Kaplan: And then, if I may, a couple more questions. In terms of clobetazole, when do you think you'll be able to launch that? It seems like you've been delayed a little bit this summer, and when do you think you'll be able to have that?

Michael Rowe: So Bren's actually talking with them to figure out the transportation and other logistics, but we're not going to wait for it to show up on the dock. We have our sales reps out there today pre-qualifying those offices. So far, the reaction has been very positive. They like the clinical profile. What they like even more is how easy we're making it for them so that they're not going to get callbacks and changes at the pharmacies and other things because we have priced the product at the same price as a branded co-pay.

Michael Rowe: So Bren's actually talking with them to figure out the transportation and other logistics, but we're not gonna wait for it to show up on the dock. We have our sales reps out there today, pre-qualifying those offices. So far, the reaction has been very positive. They like the clinical profile. What they like even more is how easy we're making it for them so that they're not going to get callbacks and changes at the pharmacies and other things because we have priced the product at the same price as a branded co-pay. So we've removed that whole problem of people not wanting to pay and switching from the equation.

Michael Rowe: Offices and institutions, including the University of California and Premier Buying Groups like Vision Source, have selected mid-convy for several compelling reasons. Unlike traditional eyedrops, mid-convy spray delivers precise amount of medication, making the dilation process cleaner and more efficient, but clinical studies had reported virtually no singing, ensuring a comfortable experience for patients. Its hygienic design eliminates protruding tips, reducing the risk of cross contamination between patients. Moreover, mid-convy works reliably and quickly, studying it apart from other options.

Speaker Change: So Bren's actually talking with them to to figure out the transportation and other logistics

Speaker Change: But we're not going to wait for it to show up on the dock. We have our sales reps out there today.

Speaker Change: Eric Ribner, John Gandolfo, Michael Rowe, Eric Ribner, Bren Kern, John Gandolfo, Michael

Speaker Change: changes at the pharmacies and other things because we have priced the product at the same price as a branded co-pay. So we've removed that whole problem of people not wanting to pay and switches from the equation.

Michael Rowe: So we've removed that whole problem of people not wanting to pay and switching from the equation, and we can do that because we're being extremely efficient with the way that we're distributing it through ourselves and through one e-pharmacy partner who's well known in ophthalmology and to the optical offices as well. So I'm hoping that that happens within, you know, by the end of the summer, sometime in September, but in any case, it's not like we're sitting here doing nothing.

Michael Rowe: And we can do that because we're being extremely efficient with the way that we're distributing it through ourselves and through one e-pharmacy partner who's well known in ophthalmology and to the optical offices as well. So I'm hoping that that happens by the end of the summer, sometime in September. But in any case, it's not like we're sitting here doing nothing.

Bren Kern: At this point, I'd like to turn the call over to our chief operating officer, Bren Kern, for our manufacturing update. Bren? Thanks, Michael. Our engineering, manufacturing, and quality and regulatory teams have been focusing on bringing our advanced Gen2 off-digit device to the market. As a reminder, our Gen2 platform offers the same performance as our first generation platform, but simplifies the user experience by utilizing motor control actuation and a sleeper profile. This design has also been assessed for scalability, offering fewer production steps, thus bringing us closer to our cost-of-biz targets.

Speaker Change: And we can do that because we're being extremely efficient with the way that we're distributing through ourselves and through one e-pharmacy partner who's well-known in ophthalmology and to the optical offices as well.

Speaker Change: So, I'm hoping that that happens within, by the end of the summer, sometime in September. But in any case, it's not like we're sitting here doing nothing. We're out there pre-qualifying these offices, and that's the job of the sales force, to make sure those people are ready so that when it becomes available, they can turn the switch on and start using it immediately.

Michael Rowe: We're out there pre-qualifying these offices, and that's the job of the sales force to make sure those people are ready so that when it becomes available, they can turn the switch on and start using it immediately. Okay, that makes sense. And then last question, you've signed, I guess, three dry eye collaborations in the last, very recently. Can you talk a little bit about the strategy with these collaborations for dry eye? I guess you have one for flare-ups, one's adjunctive, and one's for chronic therapy, and how to think about those.

Matthew Kaplan: Okay, that makes sense. And then last question, you've signed, I guess, three dry eye collaborations in the last, very recently. Can you talk a little bit about the strategy with these collaborations for dry eye? I guess you have one for flare-ups, one's adjunctive, and one's for chronic therapy, and how to think about those. Yeah, thank you.

Speaker Change: Okay, that makes sense. And then last question, you've signed, I guess, three dry eye collaborations in the last, very recently. Can you talk a little bit about the strategy with these collaborations for dry eye? I guess you have one for flare-ups, one's adjunctive, and one's for chronic therapy, and how to think about those.

Bren Kern: Additionally, the Gen2 device is being designed for future enhancements, such as our Digital Monitoring Program, OptiCare. Villain finish operations for the Gen2 platform are performed at a Redwood City facility. Recently, the production team completed our fourth media field with passing results, verifying the aseptic process and readying our systems to produce registration batches of mid-county. The mid-county bulk drug is scheduled to ship this week, where three manufacturing lots will subsequently be filled into the Gen2 device and are evaluated in a 12-month stability study.

Michael Rowe: Yeah, thank you. The first thing is that what's nice about this is that the three are not competitive with each other. You have the SGN product, which is a more rapidly acting cyclosporine. So they say that they work, I believe, in four weeks, and typically cyclosporine will take 12, so people will get faster relief. So this is a way to take their product, which could be a foundation product, the first one you go in with dry eye, and put it into the oxygen system to make it easier to use, and also to differentiate their cyclosporine from other products that are out there.

Michael Rowe: Yeah, thank you. The first thing is that what's nice about this is that the three are not competitive with each other. You have the SGN product, which is a more rapidly acting cyclosporine. So they say that they work, I believe, in four weeks, and typically, it will take 12. So people will get faster relief. So this is a way to take their product, which could be a foundation product. The first one you go in with dry eye and put it into the oxygen system to make it easier to use and also to differentiate their cyclosporine from other products that are out there.

Speaker Change: Yeah, thank you

Speaker Change: So the first thing is that what's nice about this is that the three are not competitive with each other.

Speaker Change: You have the SGN product, which is a more rapidly acting

Speaker Change: Cyclosporine, so they say that they work I believe in four weeks and typically cyclosporine will take 12, so people get faster relief

Bren Kern: The UNICEF comprises study are commonly referred to as registration batches, as the results of these studies are used to prove the drug product remains stable within the container over an extended duration. We anticipate the completion of manufacturing for the registration batches at the end of this year. The data collected over the subsequent 12 months will then be submitted to the FDA for its review. Similarly, the Gen2 device also needs to undergo functional testing to obtain FDA approval.

Speaker Change: So this is a way to take their product, which could be a foundation product, the first one you go in with dry eye, and put it into the OptiJet system to make it easier to use and also to differentiate their cyclosporine from other products that are out there. Then you have the SendU product, which works with a completely different mechanism.

Michael Rowe: Then you have the SendU product, which works with a completely different mechanism but may need to be paired with something like cyclosporine or lifidigrass so that you get the benefit. Think of it as almost like the glaucoma model where half of the patients are on two different glaucoma meds. This could be a dry eye where half of the patients are on two different dry eye products.

Michael Rowe: Then you have the SendU product, which works with a completely different mechanism but may need to be paired with something like cyclosporine or lifidigrass so that you get the benefit. Think of it as almost like the glaucoma model where half of the patients are on two different glaucoma meds. This could be in dry eye, where half the patients are on two different dry eye products. So it could be an adjunct to almost anything.

Speaker Change: but may need to be paired with something like a cyclosporine or a lifidigrass so that you get the benefit. Think of it as almost like the glaucoma model where half of the patients are on two different glaucoma meds. This could be a dry eye where half the patients are on two different

Bren Kern: On July 23rd of this year, we received feedback from the FDA regarding our Type-C meeting requests to discuss the qualification of the Gen2 platform. Content of the Type-C meeting included an extensive overview of the Gen2 device qualification plans covering each aspect of testing we intend to perform. The feedback from the FDA was largely in agreement with our plans, providing high confidence that when complete, the requirements of the FDA will be fully satisfied.

Michael Rowe: So it could be an adjunct to almost anything. So it's non-competitive, and it's really a unique way of looking at the marketplace. And then you have clovetazole, which would be used for acute dry eye flare-ups, which typically happen four or five times to people that have dry eyes where they get a flare-up, and they need something to knock down the inflammation.

Michael Rowe: So it's non-competitive, and it's a really unique way of looking at the marketplace. And then you have clovetazole, which would be used for acute dry eye flare-ups, which typically happen four or five times to people that have dry eyes where they get a flare-up, and they need something to knock down the inflammation. So it's a way of getting that also out in the market and differentiating it from the post-surgical steroid. So we looked at the three as almost like a good way to load up the bases and have a product at each stage, and hopefully, we'll be able to come to the plate and knock all of those home. Thank you.

Speaker Change: Dry Eye Products. So it could be an adjunct to almost anything. So it's non-competitive and it's a really a unique way.

Speaker Change: of looking at the marketplace.

Speaker Change: And then you have clovezol, which would be used for acute dry eye flare-ups, which typically happen four or five times to people that have dry eye where they get a flare-up and they need something to knock down the inflammation.

Michael Rowe: So it's a way of getting that also out in the market and differentiating it from the post-surgical steroid. So we looked at the three as a way to load up the bases and have a product at each stage, and hopefully, we'll be able to come to the plate and knock all of those home. Thank you. Thank you. Thanks, Michael. Thanks, Matt.

Bren Kern: Our engineering team is now detailing the associated protocols and scheduling applicable tests. We are targeting the completion of our first round of testing in early 2025. This provides ample time to complete the associated reports and FDA submission package on or before receiving the results of the aforementioned stability studies. The work we are doing to qualify the Gen2 Macombie platform provides us with a model that we're able to apply to other drug platforms.

Speaker Change: So it's a way of getting that also out in the market and differentiating it from the post-surgical steroid. So we looked at the three as a, almost like a good way to load up the bases and have a product at each phase and hopefully we'll be able to come to the plate and knock all of those home. Thank you.

Operator: Our next question is from Kemp Dolliver with Brookline Capital Markets. Please proceed.

Operator: Our next question is from Kemp Dolliver with Brookline Capital Markets. Please proceed. Great. Thank you. And good evening.

Speaker Change: Thanks. Thanks, Michael.

Bren Kern: For instance, upon receiving FDA approval for the Gen2 Macombie subsequent device testing will likely be limited to verifying key performance characteristics for the new drugs and or any new features we wish to incorporate. These tests comprise a minority of device testing offering expediency for future platform qualifications. For example, the Gen2 platform for Macombie will incorporate features only necessary for office use. But for microphone, we will add additional features such as the OptiCare digital compliance system and child safety lockout feature enabling a more desirable home use platform.

Bren Kern: The work we are doing to qualify the Gen2 Macombie platform provides us with a model that we're able to apply to other drug platforms. For instance, upon receiving FDA approval for the Gen2 Macombie subsequent device testing will likely be limited to verifying key performance characteristics for the new drugs and or any new features we wish to incorporate. These tests comprise a minority of device testing offering expediency for future platform qualifications. For example, the Gen2 platform for Macombie will incorporate features only necessary for office use.

Speaker Change: Thanks a lot.

Speaker Change: Our next question is from Kemp Deliver with Brookline Capital Markets. Please proceed.

Kemp Dolliver: Great. Thank you. And good evening. The first question is, you know, the revenue numbers that you are booking right now and how can we think about them in the context of you seeding the market for mid combi, and then presumably, as we get later in the year, we should see some clobetisol revenue.

Kemp Dolliver: The first question is, you know, the revenue numbers that you are booking right now and, you know, how can we think about them in the context of the year you're seeding the market for mid combi, and then presumably, as we get later in the year, we should see some Clobetisol revenue. Yeah, I think that so we haven't given guidance yet. We will give guidance, obviously, once we launch the product. But I think that ultimately, the goal is to capture a three to 5% market share over a 12 to 15 month period for Clabetasol.

Kemp Deliver: Great. Thank you and good evening. First question is, you know, the revenue numbers that you are booking right now and, you know, how can we think about them in the context of

Speaker Change: You're seeding the market for mid-combi, and then presumably as we get later in the year, we should see some clabetosol revenue.

Bren Kern: But for microphone, we will add additional features such as the OptiCare digital compliance system and child safety lockout feature enabling a more desirable home use platform. The engineering team need only to focus on these new features as the Macombie design has already provided base platforms from which to build upon. Additionally, the system enable us to best support potential licensing partners in nutrient applications such as dry eye. As mentioned by Michael, our manufacturing team performed still and efficient activities for SCN's phase three ready, ophthalmic cyclist form formulation SG 101 at the end of July.

Kemp Dolliver: Yeah, I think that we haven't given guidance yet. We will give guidance, obviously, once we launch a product, but I think that

Speaker Change: Yeah, I think that, so we haven't given guidance yet, we will give guidance obviously once we launch the product, but I think that ultimately the goal is to capture a

Bren Kern: The engineering team need only to focus on these new features as the Macombie design has already provided base platforms from which to build upon. Additionally, the system enable us to best support potential licensing partners in nutrient applications such as dry eye. As mentioned by Michael, our manufacturing team performed still and efficient activities for SCN's phase three ready, ophthalmic cyclist form formulation SG 101 at the end of July. I know via an SCN will not collaborate to discuss on the next steps, which may include a preliminary stability evaluation or additional device related testing.

Speaker Change: 3-5% market share over a 12-15 month period for Clemetisol.

Kemp Dolliver: And Kev, in terms of timing, you're right, right now is when we don't, we're conditioning the market. Yeah.

Kemp Dolliver: And Kev, in terms of timing, you're right, right now we don't have any numbers for MidCombi and Clobetazole. I think that you'll be seeing numbers in the fourth quarter for that, because the reps are out there now, again, with the goal that they're going to hit 200 additional new offices for MidCombi between now and the end of September. And then they're responsible for getting to 500 Clobetazole offices once the product is here. So that would probably be September or October.

Kepp: and Kepp in terms of timing.

Kemp Dolliver: For MidCombi and Clobetazole, I think that you'll be seeing numbers in the fourth quarter for that because the reps are out there now, again, with the goal that they're going to hit 200 additional new offices for MidCombi between now and the end of September. And then they're responsible for getting to 500 Clobetazole offices once the product is here. So that would probably be September or October. So when you're going to actually see those revenues, it will be in the fourth quarter, I would presume.

Speaker Change: You're right, right now is...

Kepp: We're conditioning the market for Midcombia and Pobetazol. I think that you'll be seeing numbers in the fourth quarter.

Bren Kern: I know via an SCN will not collaborate to discuss on the next steps, which may include a preliminary stability evaluation or additional device related testing. Our model for evaluating new drugs begins with a small spray ability study utilizing our first generation device to assess delivery volume. This preliminary session is short duration, typically less than a month, and provides idea in any potential partner with confidence about drug delivery performance in the OptiCare platform.

Kepp: for that, because the reps are out there now, again, with the goal that they're going to hit 200 additional new offices.

John Gandolfo: So when you're going to actually see those revenues would be in the fourth quarter, I would presume. Right, just to dig into this a little bit more, because it's an atypical situation, which you've explained clearly, last quarter, you had, you know, minimal revenue, but cost of goods at the same level. This quarter, you had a negative gross margin. You know, what accounts for that difference? Yeah, so. That's actually included in that cost of revenue is the one-time write-down of inventory to a net realizable value of about $450,000.

Kepp: for MidCombie between now and the end of September. And then they're responsible to getting to 500 Clevetha's Hall offices once the product is here. So that would probably be September, October. So when you're going to actually see those revenues would be with the fourth quarter, I would presume.

Bren Kern: Our model for evaluating new drugs begins with a small spray ability study utilizing our first generation device to assess delivery volume. This preliminary session is short duration, typically less than a month, and provides idea in any potential partner with confidence about drug delivery performance in the OptiCare platform. With this heard clear, we then begin discussing manufacturing the product and conducting appropriate engineering tests. In the case of SCN has included film finish operations for cyclist foreign in the second generation platform.

Kemp Dolliver: All right, just to dig into this a little bit more, because it's an atypical situation, which you've explained clearly, last quarter, you had minimal revenue, but cost of goods at the same level. This quarter, you had a negative gross margin. What accounts for that difference?

John Gandolfo: So, if you take out that, and that's a non-recurring expense, so if you take that out, you would have seen the revenue and the cost of revenue basically be equal to each other as they had been in prior quarters. But we did take one charge associated with that, which is included in that $490,000 number. Great, thank you, and moving on to other things that are probably a little more interesting. You know, looking at the dry eye program.

Speaker Change: Just to dig into this a little bit more, because it's an atypical situation, which you've explained clearly, last quarter you had

Bren Kern: With this heard clear, we then begin discussing manufacturing the product and conducting appropriate engineering tests. In the case of SCN has included film finish operations for cyclist foreign in the second generation platform. The collaborative and progressive nature of testing ensures critical aspects associated with introducing a new drug into the OptiCare platform are properly developed before engaging in a full platform. These types of details are covered in the development agreements we established with each potential licensing partner.

Speaker Change: Minimal revenue but cost of goods at the same level. This quarter you had negative gross margin. What accounts for that difference?

The collaborative and progressive nature of testing ensures critical aspects associated with introducing a new drug into the OptiCare platform are properly developed before engaging in a full platform. These types of details are covered in the development agreements we established with each potential licensing partner.

Kemp Dolliver: Yeah, so that's actually included in that cost of revenue, the one-time write-down of inventory to a net realizable value of about $450,000. So if you take out that, and that's a non-recurring expense, so if you take that out, you would have seen the revenue and the cost of revenue basically be equal to each other as they had been in prior quarters. But we did take one charge associated with that, which is included in that $490,000 number.

Speaker Change: Yeah, so that's actually included in that cost of revenue.

Speaker Change: is the one-time write-down of inventory to net realizable value of about four hundred and fifty thousand dollars.

Bren Kern: While all of this is going on, we are also still be just beginning to commercialize our first off-digit-based product, mid-convy. Production continues to progress as planned, and as a reminder, earlier this year, our Redwood City Facility was approved by the FDA to conduct final assembly, labeling, and packaging of mid-convy in our general platform. This addition, coupled with the capabilities of our CMO and Arena Facility, provides synergies and manufacturing by allowing them to occur in relative close proximity and within the same time zone.

Speaker Change: So if you take out that, and that's a non-recurring expense, so if you take that out you would have seen the revenue and the cost of revenue basically be equal to each other as it happened in prior quarters.

Speaker Change: but we did take one time charge associated with that which is included in that $490,000 number.

Kemp Dolliver: Great, thank you, and moving on to other things that are probably a little more interesting. Looking at the dry eye program. And admittedly, this may be too early to speak about, but are we looking at the same endpoints in registrational trials, or will there be some variation?

Bren Kern: This provides Imovia with greater control and scheduling flexibility, which we are leveraging to our advantage. Moving to Coledisol, our distribution systems have largely been established, and as a reminder, our Redwood City Facility will serve as the distribution center. These preparations should enable the Imovia sales team, as well as our co-promotion partner Nova Bay, to immediately begin selling upon receiving the Venezuel product.

Speaker Change: Great. Thank you. And ...

Speaker Change: Moving on to other things that are probably a little more interesting. Looking at the dry eye programs,

John Gandolfo: And admittedly, this may be too early to speak to, but are we looking at the same endpoints in registrational trials, or will there be some variation? Oh, great question, Kev. Actually, they're all different from each other, so it's a perfect question.

Speaker Change: And admittedly this may be too early to speak to, but are we looking at the same endpoints and registrational trials or will there be some variations?

Kemp Dolliver: Oh, great question, Kev. Actually, they're all different from each other, so it's a perfect question.

Bren Kern: My enthusiasm for the activities plans, most importantly, our future, has never been higher. We have an amazing delivery platform, incredible team, and have engaged with potential partners that can leverage the Optige Up platform in treatments to benefit those afflicted by debilitating eye disease.

Michael Rowe: So, if we look at clobetazole, since that's an acute dry eye, you're talking about two 15-day trials. Those who would be the shore this, If you look at SGN cyclosporine, because the safety profile of cyclosporine is well understood, you're probably looking at a 16-week trial in chronic dry. And again, I'm saying all of this; it has to be verified with the FDA, but this is my understanding. And if you look at Senju's product with ours, that potentially could be the longest one with the actual one year plus a 16-week treatment because they would have to establish, or we would have to establish, long-term safety.

Speaker Change: Oh, great question, Kev. Actually, they're all different from each other, so it's a perfect question. So if we look at clomethazole, since that's acute dry eye, you're talking about two 15-day trials.

Kemp Dolliver: So if we look at clobetazole, since that's an acute dry eye, you're talking about two 15-day trials. Those who would be the shore this, If you look at SGN cyclosporine, because the safety profile of cyclosporine is well understood, you're probably looking at a 16-week trial in chronic dry. And again, I'm saying all of this; it has to be verified with the FDA, but this is my understanding. And if you look at Senju's product with ours, that potentially could be the longest one with the actual one year plus a 16-week treatment because they would have to establish, or we would have to establish, long-term safety. So, you know, in summary, again, clobetazole 15 weeks, SGN probably 15 days, SGN probably 16 weeks, and Senju would likely be one year unless that data already exists somewhere, and I'm not familiar with that.

Speaker Change: That would be the shore of the swamp.

John Gandolfo: I would now like to turn the call over to our Chief Financial Officer, John Gendolson. John? Thank you, Brent. For the second quarter of 2024, we reported net loss of approximately $11.1 million or $21 cents per share on approximately 53.1 million weight-labor shares have standing. This includes a five-cent loss related to the $2.9 million of costs for bringing a micro-peam back to Imovia, and a two-cent gain included another income from a changing fair value of equity consideration pay-ball.

Speaker Change: If you look at SGN cyclosporine, because the safety profile of cyclosporine is well understood, you're looking probably at a 16-week trial in chronic dry. And again, I'm saying all of this, it has to be verified with the FDA, but this is my understanding.

John Gandolfo: This compares to a net loss of $6.2 million or $16 cents per share, and approximately $38.1 million weight-labor shares have standing for the second quarter of 2023. Research and development expenses totaled approximately $4.6 million for the second quarter of 2024, and it's compared to $2.8 million for the first quarter of 2023, an increase of 64 percent. This increases largely the results of expensing previously deferred clinical supplies, and this was related to the reacquisition of the license rate from Bowshenlo.

Speaker Change: And if you look at...

Speaker Change: Benju's product with ours.

Speaker Change: that potentially could be the longest one with the actual one year plus a 16 week because they would have to establish or we would have to establish long-term safety. So you know in summary again, clobetazole 15 weeks, SGN probably 15 days.

Michael Rowe: So, you know, in summary, again, clobetazole 15 weeks, SGN probably six, 15 days, SGN probably 16 weeks, and Senju would likely be one year unless that data already exists somewhere and I'm not familiar with it. That's very helpful, thanks. This is John.

Speaker Change: SGN probably 16 weeks and CENGIEW would likely be one year unless that data already exists somewhere and I'm not familiar with it.

Kemp Dolliver: That's very helpful. Thanks.

Speaker Change: That's very helpful, thanks.

John Gandolfo: This is John. Let me just make one more point because you had raised something about the cost of revenues. That was a very good point. But the other thing I want to point out is this quarter includes a lot of expenses that are non-recurring relating to us buying back the rights from Bausch and Lohm. So when you look at it, we reported a total operating expenses of $11.2 million, but when you strip away the reacquisition of the rights as well as all of the non-cash charges and expenses related to the Ba'al Shalo

John Gandolfo: Let me just make one more point because you had raised something about the cost of revenues. That was a very good point. But the other thing I want to point out is this quarter includes a lot of expenses that are non-recurring relating to us buying back the rights from Bausch & Lohm. So when you look at it, we reported a total operating expense of $11.2 million, but when you strip away the reacquisition of the rights as well as all of the non-cash charges and expenses related to the Ba'al Shalom transaction.

Speaker Change: This is John. Let me just make one more point, because you had raised something with the cost of revenues. That was a very good point.

Speaker Change: But the other thing I want to point out is this quarter includes a lot of expenses that are non-recovering relating to us buying back the the rights from Bausch and Lomb.

John Gandolfo: In addition, the company had increased internal engineering expenses related to development of the Gen2 OptiJet system. For the second quarter of 2024, GNA expenses were approximately $3.8 million as compared to $3.1 million for the second quarter of 2023, an increase of 19 percent. This increase was comprised of a $374,000 increase in salaries and benefits primarily related to the hiring of our internal sales force for the start of the company's commercialization and efforts, as well as $255,000 related to a non-mercuring FDA fee.

Speaker Change: So when you look at it, we reported a total operating expenses of $11.2 million. But when you strip away

Speaker Change: The reacquisition of the rights, as well as all of the non-cash charges and expenses related to the Ba'al Shalom transaction.

John Gandolfo: We expect going forward that our R&D and G&A will be a total of $6 to $6.1 million going forward. And I just want to make everybody who's on the call aware that, you know, if you look at it at face value, it looks like we're increasing our expenses dramatically, but that's not the case at all. It's really tied to that Bausch & Lomb transaction. Thanks, John.

Speaker Change: We expect going forward that our R&D and G&A will be a total of, you know, $6 to $6.1 million going forward. And I just want to make everybody who's on the call aware of that.

Speaker Change: you know, if you look at it at face value, it looks like we're increasing our expenses dramatically, but that's not the case at all. It's really tied to that voucher loan transaction.

John Gandolfo: Total operating expenses for the second quarter of 2024 were approximately $11.2 million, including the previously mentioned $2.9 million in repatriation costs for bringing micro-peaned back to winovia, and this compares to $6 million for the same period of 2023. This represents an increase of approximately 88 percent. Our second quarter took 2024 operating expense figure, included approximately $3.8 million of non-cash expense, at June 30th, 2024, we reported unrestricted cash of approximately $2.3 million, and this excludes approximately $5.8 million of capital that was raised after June 30th, 2024.

John Gandolfo: Thanks for that, John. Next, two more questions. The first one is the timeline for the Gen 2 filing that you outlined in the press release and the discussion.

Kemp Dolliver: Next, two more questions. The first one is the timeline for the Gen 2 filing that you outlined in the press release and the discussion, that's unchanged, correct? That we're probably looking at approval in 2026.

John: Thanks for that, John.

John: Next, two more questions. The first one is the timeline for the Gen 2 filing.

John Gandolfo: Now, that's unchanged, correct? That we're probably looking at approval in 2026? Yeah, we're actually manufacturing, Bren, you can correct me. We're manufacturing in the fourth quarter, correct?

Speaker Change: that you outlined in the press release and the discussion. Now, that's unchanged, correct? That we're probably looking at an approval in 2026?

Kemp Dolliver: Yeah, we're actually manufacturing, Bren, you can correct me. We're manufacturing in the fourth quarter, correct?

Speaker Change: Yeah, we're actually manufacturing, Bren, you can correct me, we're manufacturing in the fourth quarter, correct?

Bren Kern: Yes, we are producing registration batches in the fourth quarter of this year to put that skill building program in place to support the filing with the FDA. So your timeline is correct.

Bren Kern: Yes, we are producing registration batches in the fourth quarter of this year to put on that skill building program to support the filing with the FDA. So your timeline is correct. Yeah, so that would be 12 months from there we can file the NDA and SNDA. Great, thanks. And the last question relates to the cash runway. Are we still looking at a runway into the end of this year?

Bren Kern: Yes, we are producing registration batches in the fourth quarter of this year to put on that skill building program to support the filing with the FDA. So your timeline is correct.

Kemp Dolliver: Yes, so that would be 12 months from now. We can file the NDA or SNDA then.

John Gandolfo: In addition to the currently resources that we have available, the company is currently evaluating a wide range of capital raising structures and initiatives in order to fund our ongoing strategy. In addition, we will continue to look at ways to improve our operating efficiencies and potentially reduce operating expenses going forward.

Speaker Change: Yes, so that would be 12 months from there we can file the NDA, SNDA.

Kemp Dolliver: And the last question pertains to the cash runway. Are we still looking at a runway into the end of this year?

Speaker Change: Great, thanks. And the last question pertains to the cash runway. Are we still looking at a runway into the end of this year? Are we...

Kemp Dolliver: Are we? Thank you. Thank you. Thank you.

John Gandolfo: Are we, Is that any different now? Now, I think that in terms of our expenses, we're still looking at them towards the end of this year. We do have access to capital today if we want it, as well as, as I mentioned in my remarks, we are looking at a lot of different structures, whether it be subordinated debt or convertible debt, that might add capital as well.

Kemp Dolliver: Now I think that in terms of our expenses, we're still looking at them towards the end of this year. We do have access to capital today if we want it, as well, or, as I mentioned in my remarks, we are looking at a lot of different structures, whether it be subordinated debt or convertible debt, that might add capital as well. But I think that that's still accurate.

Speaker Change: Is that any different now?

John Gandolfo: I'll now provide an update on our existing licensing programs with Arctic Vision, which covers all three of our products in China and South Korea. Micropine, microline, as well as McCobby, and provides a sales royalties in addition to development milestones. Micropine, in particular, is a significant opportunity in China for pediatric myopia. If approved, Micropine could be potentially meaningful source of non-deluded funding for our company over the long term. The data license agreements have generated approximately $16 million in license fees, and we have the potential to earn an additional $25 million in net license and development milestones for Arctic Vision over the next three to four years.

Speaker Change: No, I think that in terms of our expenses, we're still looking at it towards the end of this year.

Speaker Change: We do have access to capital today if we wanted it, as well as, as I mentioned in my remarks, we are looking at a lot of different structures, whether it be subordinated debt, convertible debt, that might add capital as well. But I think that that's still accurate at this point.

John Gandolfo: But I think that that's still accurate at this point. Great, thanks so much. Thank you, Cam. Our next question is from Tim Lugo with William Blair. Please proceed. Hey guys, this is Lachlan on for Tim.

Kemp Dolliver: Great, thanks so much.

Operator: Our next question is from Tim Lugo with William Blair. Please proceed.

Speaker Change: Great, thanks so much.

Cam: Thank you, Cam.

Speaker Change: Our next question is from Tim Lugo with William Blair. Please proceed.

Timothy Lugo: Hey guys, this is Lachlan on for Tim. Thanks for taking the questions. On the mid-combi adoption, I was just wondering if you could provide more color on sort of the cadence of that throughout the second quarter because that obviously sounds like it grew decently and is growing perhaps even quicker in Q3, so maybe it's the pace through Q2 and now we should expect that to track into Q3, and then is Q3 going to be a sort of steady state or will it keep growing from there?

Timothy Lugo: Thanks for taking the questions. On mid-combi adoption, I was just wondering if you could provide more color on sort of the cadence of that throughout the second quarter because that obviously sounds like it grew decently and is growing perhaps even quicker in Q3, so maybe it's the pace through Q2 and now we should expect that to track into Q3, and then is Q3 going to be a sort of steady state or will it keep growing from there? And related to that, the centers that haven't adopted yet, maybe the ones that you've approached but haven't adopted it, can you talk about why they haven't adopted it?

Lachlan: Hey guys, this is Lachlan on for Tim. Thanks for taking the questions. On the mid-combi adoption, I was just wondering if you can provide more color on sort of the cadence of that throughout the second quarter, because that obviously sounds like it grew decently and is growing perhaps even quicker in Q3, so maybe it's the cadence through Q2 and now we should expect that to track.

John Gandolfo: Included in this amount is approximately $1.5 million to $2 million expected to be received over the next six to nine months. As I said previously, if our products are approved, upon commercialization, I know VIA is also eligible to earn significant sales royalties. We are continuing to assess potential pipeline expansion opportunities similar to our Formosa, Senju, and SGN agreements, and we will continue to leverage the updated technology to address unmet needs and additional large economic indications, beginning with dry eye. As Michael indicated earlier, we believe the steps we have taken today create a solid foundation for which to drive meaningful sales growth in 2025 and beyond.

Timothy Lugo: And related to that, on the centers that haven't adopted yet, maybe the ones that you've approached but haven't adopted it, can you talk about why they haven't adopted it? And then, one other follow-up on the dry eye collaborations. As you noted, you sort of have three covering all three areas of treatment. Should we think of that as sort of... Maybe no more dry eye deals in the near term, or are you still open, and perhaps more importantly, a partner is still open to you developing or partnering for multiple products in the same space?

Lachlan: Q3, and then is Q3 going to be a sort of steady state, or will it keep growing from there?

Speaker Change: and related to that on the sentence that...

Speaker Change #100: haven't adopted yet. Maybe the ones that you've approached but haven't adopted it.

Michael Rowe: And then one other follow-up on the dry eye collaborations. As you noted, you sort of have three, covering all three areas of treatment. Should we think of that as sort of... Maybe no more dry eye deals in the near term, or are you still open, and perhaps more importantly, a partner is still open to you developing or partnering for multiple products in the same space? Well, let me take the second one first, and thank you, Tim.

Speaker Change #101: Can you talk about why they haven't adopted it? And then one other follow-up on the dry eye collaborations. As you noted, you sort of have three, covering all three areas of treatment. Should we think of that as sort of...

Speaker Change #102: maybe no more dry eye deals in the near term or are you still open to and perhaps more importantly a partner is still open to you developing or partnering for multiple products in the same space.

John Gandolfo: In conclusion, we are very pleased with our performance in the second quarter of 2024, and summarize our key highlights today. We are preparing for a full analysis of data from our ongoing phase three chapter on trial of Micropine, pediatric progressive myopia, which if positive would allow us to significantly advance it for remaining development timelines. We entered into development collaborations with Formosa, Senju, and SGN to develop novel therapeutic formulation for the opti-jet that would potentially address unmet needs and acutement chronic dry eye disease.

Michael Rowe: Well, let me take the second one first, and thank you, Tim. The Dry Eye Collaboration... It's funny that you're asking this because I just came back personally from an office that we trained about a week ago because I wanted to see what was going on out there. And I think that the reason our cycle is picking up is that our sales force is in place, and they are figuring out how to do this. The general interest and acceptance of MidCombi is high. What happens, though, is that people are used to using eyedrops. They've been around for 150 years.

Michael Rowe: The Dry Eye Collaboration... Unknown Speaker at this moment is non-exclusive. So if something that makes more sense for us as a company, we would certainly consider that. So we haven't shut any doors. And what I'm hoping that people will see and potential partners will see is that interest in our technology is picking up as a great way to extend the runway for things that might have a short patent life or to be more competitive in this market.

Speaker Change #103: Well, let me take the second one first, and thank you, Tim. The giant eye collaboration.

Speaker Change #103: as of this moment are non-exclusive.

Speaker Change #104: So if, you know, it's something

Speaker Change #104: All of that makes more sense for us as a company.

Speaker Change #104: We would certainly consider that. So we haven't shut any doors.

Tim Lugo: Thank you.

Speaker Change #106: and what I'm hoping...

Speaker Change #106: that people will see and potential partners will see is that interest in our technology is picking up as a great way to extend the runway for things that might have a short patent life or to be more competitive in this market.

John Gandolfo: We entered into a co-promotion agreement with Nova Bay Pharmaceuticals, whereby Nova Bay will market the better soil for which U.S, physician dispense channel. And the agreement also gives us access to their prescription, Avanova, antimicrobial, lidon-lash solution, which complement our commercial products. Our commercial launch in Macombie continues to track well with the product now in use at over 63 ophthalmology offices around the country and tracking the more than 260 buddy ended their quarter. And finally, our licensed agreement with Arctic Vision is progressing well and remains a promising avenue for significant development and regulatory milestones, as well as the potential for sales royals.

Michael Rowe: For your first question on MidCombi, it's funny that you asked this because I just came back personally from an office that we trained about a week ago because I wanted to see what was going out there. And I think that the reason our pace is picking up is that our sales force is in place, and they are figuring out how to do this. The general interest and acceptance of MidCombi is high. What happens, though, is that people are used to using eyedrops. They've been around for 150 years.

Speaker Change #107: For your first question on MidCombie, it's funny that you're asking this because I just came back personally from an office that we train.

Speaker Change #107: about a week ago because I wanted to see what was going out there and I think that the reason our cave-ins is picking up

Speaker Change #107: is that our sales force is in place and they are figuring out how to do this. The general interest and acceptance of MidCombie is high. What happens though is that people are used to using eye drops. They've been around for 150 years.

Michael Rowe: So the way it works is you bring MidCombi into the office, you find a champion, a tech, for example, who really likes the product and wants to use it first. And he or she is the one that introduces it into the practice. And soon, everybody else gets used to it as well and finds all the reasons that it's superior to the way that they're doing things now.

Michael Rowe: So the way it works is you bring MidCombi into the office, you find a champion, a tech, for example, who really likes the product and wants to use it first. And he or she is the one that introduces it into the practice, and soon everybody else gets used to it as well and finds all the reasons that it's superior to the way that they're doing things now. The issue is that that takes time.

Speaker Change #108: So, the way it works is you bring Vidconvia to the office, you find a champion, a tech for example, who really likes the product and wants to use it first, and he or she is the one that introduces it within the practice and soon everybody else.

Unknown Executive: That concludes our prepared remarks.

Unknown Executive: We would now like to open the call to questions. Operator? Thank you. If you would like to ask a question, please press star one on your telephone keypad. A confirmation to indicate your line is in the question queue. You may press star two if you would like to remove your question from the queue. And for participants using speaker equipment and maybe necessary to pick up your handset before pressing the star keys. One moment, we'll pull for questions.

Speaker Change #108: gets used to it as well and finds all the reasons that it's superior to the way that they're doing things now.

Michael Rowe: The issue is that that takes time. So the way the sales process works is our sales representatives need to get into the office. Once they're there, they have to do a quick training session with everybody to introduce it because it is completely different from anything they've seen before.

Michael Rowe: So the way the sales process works is our sales representatives need to get into the office. Once they're there, they have to do a quick training session with everybody to introduce it because it is completely different from anything they've seen before. They will stick around for a while to make sure everybody is using it correctly and doesn't have any questions. And then, over the next couple of weeks, they check back in to see how everything is.

Speaker Change #108: The issue is that that takes time.

Speaker Change #108: So the way the sales process works is our sales representatives need to get into the office.

Michael Rowe: They will stick around for a while to make sure everybody is using it correctly and doesn't have any questions. And then, over the next couple of weeks, they check back in to see how everything is. And I've seen this time and time again that you get that one person or two people in there who really like it, and all of a sudden, you have a half dozen in all of the tech who like it soon after that. So what we've learned is we have to have patience, and we have to do it right. And then once we do, that's how we get the reorders.

Speaker Change #108: Once they're there, they have to do a quick training of everybody to introduce it because it is completely different from anything they've seen before. They will stick around for a while to make sure everybody is using it correctly and doesn't have any questions.

Michael Rowe: Our first question is from Matt Kaplan with Ladden Bergthalman. Please proceed. Hey, guys, thanks for taking the question. Just do you give us a little bit more detail in terms of the path to the regulatory filing for Micropine, assuming a positive outcome of the the chaperone analysis expected in the near term in the fourth quarter. And then also kind of in that in that main talk about the also talk about the evolving competitive landscape for Micropine and Micropine and how it can be how it can differentiate.

Michael Rowe: And I've seen this time and time again that you get that one person or two people in there who really like it, and all of a sudden, you have a half dozen and all of the techs who like it soon after that. So what we've learned is we have to have patience, and we have to do it right. And then once we do, that's how we get the reorders.

Speaker Change #108: And then over the next couple of weeks, they check back in to see how everything is. And I've seen this time and time again, that you get that one person or two people in there who really like it, and all of a sudden you have a half dozen in all of the texts.

Speaker Change #108: who like it soon after that. So what we've learned is we have to have patience and we have to do it right. And then once we do, that's how we get the reorders.

Michael Rowe: The people that we found that you don't go to are you don't go into offices where they are entirely driven by, "I just want to get these patients in and out, in and out, in and out like a machine." And that's not who we are targeting. Our customer is one that cares about the patient experience and also cares about the other benefits of the product. For example, when I was in that office, they had a number of elderly patients.

Speaker Change #108: The people that we found that you don't go to is you don't go into offices where they are entirely driven by, I just want to get these patients in and out, in and out, in and out, like a machine.

Speaker Change #108: and that's not our customer. Our customer is the one that cares about the patient experience.

Michael Rowe: And when it comes to market. Thank you, Matt. The regulatory pathway would be after looking at the efficacy data, we would request a meeting with the FDA. The earliest we would probably get that meeting is the beginning. Of 2025 75 days after we ask for it for the FDA to review the efficacy data, assuming that goes well, there's also a commitment for one year of additional safety. That would be up in about September, October of 2025.

Michael Rowe: It was a glaucoma practice, and elderly patients can't tilt their heads back to have these drops put in their eyes. So it was especially helpful to use MidCombi with them because they could look straight ahead for the dilation process, and that was something that I did not even consider until I actually saw it. So I'm very encouraged by what we've seen, and I think this is the right way to do this. It reminds me of the old "try it, they'll like it" commercials because I'm confident they'll try it, and they'll like it.

Speaker Change #108: and also cares about the other benefits of the product. For example, when I was in that office,

Speaker Change #108: They had a number of elderly patients, it was a glaucoma practice, and the elderly patients can't tilt their heads back.

Speaker Change #109: to have these drops put in their eyes. So it was especially helpful to use MidCombi with them because they could look straight ahead for the dilation process. And that was something that I did not even consider until I actually saw it.

Michael Rowe: So I'm very encouraged by what we've seen, and I think this is the right way to do this. It reminds me of the old "Try it, they'll like it" commercials, because I'm confident they'll try it, and they'll like it.

Speaker Change #110: So, I'm very encouraged by what we've seen and I think this is the right way to do this. It reminds me of the old try it, they'll like it commercials because I'm confident they'll try it and they'll like it.

Michael Rowe: So when that is done, we would be able to submit the full data, full efficacy and safety information. At the same time, we plan to make registration batches of Micropine beginning the end of this year. So that by the end of 2025, we would have the efficacy, the safety and the stability data are ready for that NDA submission. And that's why we're saying the end of 2025. We're going to talk about early 2026 and then would be a 10 month review, which would take you to the middle back half of 2026 for approval.

Michael Rowe: Got it, thanks. And on the timing of the Clopidazole launch, are there any actual updates that you've had on that? Or is that, are you just delaying that because you previously said maybe August and you sort of haven't heard anything?

Bren Kern: Thanks. And on the timing of the clobetazole launch, are there actual updates that you've had on that? Or are you just delaying that because you previously said maybe August and you sort of haven't heard anything? No. Bren and I are talking...

Michael Rowe: No, Bren and I are talking with them weekly. This is all logistics and paperwork that we're combing through. It's not anything I'm terribly concerned about. It is something I'm not dancing about because I would have liked it as soon as possible.

Speaker Change #111: With them weekly, this is all logistics and paperwork that we're combing through. Not anything I'm terribly concerned about. It is something I'm not dancing about because I would have liked it as soon as possible, but I am convinced that everybody is working as quickly as they can to get the product here.

Michael Rowe: But I am convinced that everybody is working as quickly as they can to get the product here. Okay, so does Formosa have their export license then? No, they don't yet, and that's what we're working on. Okay, thanks. As a reminder, it is star one on your telephone keypad if you would like to ask a question. Our next question is from Matthew Caulfield with HC Wainwright.

Michael Rowe: In terms of the competitive landscape, there's only one other product that we are aware of that's in late stage development for this. And that product is similarly a low dose atropine, but it's an eyedrop. And we think there's a tremendous difference between using an eyedrop in pediatrics and being able to use the optogen. With the optogen, as I mentioned, the kids are doing this themselves and they have to do it every night, they brush their teeth, they spray their eyes and go to bed, but they have to do it for three years, at least to get the full benefit of the product.

Speaker Change #112: Okay, so does Formosa have their export license then?

Speaker Change #113: No, they don't yet, and that's what we're working on.

Speaker Change #114: Okay, thanks.

Speaker Change #114: Thank you.

Speaker Change #115: As a reminder, it is star one on your telephone keypad if you would like to ask a question. Our next question is from Matthew Caulfield with H.C. Wainwright. Please proceed.

Matthew Caulfield: Please proceed. Great, thank you. Hi Michael and team.

Michael Rowe: So, my question was about dry eye and kind of thinking about comparisons to standard of care. How common is it to segment those dry eye patients currently? In other words, is there any risk prescribers would ultimately be more familiar with just the overall dry eye indication itself versus breaking out inflammation patients from those that need faster relief, for example? My understanding, at least, is that they're kind of all in one bigger bucket currently. Just wanted to kind of hear your perspective on that.

Michael Rowe: So this is something that I just as a parent myself, I have difficulty imagining me having to do that every night with my children and knowing how much they would enjoy having eyedrops put in their eyes. Also our product, at least from what we're seeing in the mask data, is very well tolerated, which is not a surprise given the optogen uses a lower volume of medication. And inherent with that lower volume of medication, you're also getting less systemic exposure to the active ingredient, which when you're talking about pediatrics, you have small people using a drug over many years and you want to minimize that as much as possible.

Matthew Caulfield: Great. Thank you. Hi, Michael and team.

Matthew Caulfield: So, my question was on dry eye and kind of thinking about comparisons to standard of care.

Matthew Caulfield: How common is it to segment those dry eye patients currently?

Speaker Change #117: In other words, is there any risk prescribers would ultimately be more familiar with just the overall dry eye indication itself?

Matthew Caulfield: versus breaking out inflammation patients from those that need fast relief, for example.

Matthew Caulfield: My understanding, at least, is that they're kind of all in one bigger bucket currently.

Michael Rowe: Thanks, Matthew. Great to hear from you. I think if you spoke to a doctor who treats dry eye patients, he or she will honestly tell you that they are among the most difficult patients, Unknown Executive, Brian Dolliver, Leonard Yaffe, Eyenovia Inc., Unknown Executive, Brian Dolliver, Unknown Executive, Brian Dolliver, Unknown Executive, Brian Dolliver, Unknown Executive, Brian Dolliver, Unknown Executive, Brian Dolliver, Unknown Executive, Brian Dolliver, And then for clovetazole, I think the prescribers are very familiar with flare-ups.

Matthew Caulfield: Just wanted to kind of hear your perspective there.

Speaker Change #118: Thanks Matthew, great to hear from you. I think if you spoke to a doctor who treats dry eye patients, he or she will honestly tell you that they are among the most difficult patients.

Michael Rowe: And then lastly, you have all the benefits of the electronic optocare system, which means that parents and the kids and their doctors can see what's going on because if you don't use some medication, you don't get the benefit. And we want to make sure that everybody gets that benefit and then we have seen from the initial compliance data that the kids are using it more often and more regularly than one would expect from an eye drop.

Speaker Change #119: to treat because they are in a lot of discomfort and not, you know, there's nothing that works for everybody.

Speaker Change #120: And, in fact, I think I saw some research that even with Restasis,

Speaker Change #120: Fewer than half of the patients actually are satisfied with the relief that they get. So what happens now is they might try one drug or they might try the other and when it doesn't work, they'll switch to another drug.

Michael Rowe: So I think, you know, competitively, competitively will be in a very good place because of the marriage between the drug and the optogen. Professor. Okay, that's, that's really helpful. Thank you, Michael. And then, and then if I make a couple more questions, um, in, in terms of club, that is all, when do you think you'll be able to, to launch that, it seems like you've been delayed a little bit, the summer and when do you think to be able to have that on the market.

Speaker Change #121: So, what I like about the SGN Faster Working Restasis is that you'll get an answer as to whether this is going to work or not much faster than you would with the existing products out there. Plus, it's easier to use with the OptiJet.

Speaker Change #122: What I like about the Senju product is that because it works differently, you can add it on.

Michael Rowe: So brands actually talking with them to, to figure out the transportation and other logistics, but we're not going to wait for it to show up on the dock. We have our sales reps out there today, pre-qualifying those offices. So far, the reaction has been very positive. They like the clinical profile. What they like even more is how easy we're making it for them so that they're not going to get callbacks and changes that the pharmacies and other things because we have priced the product at the same price as a branded copay.

Speaker Change #122: to anything. So instead of switching, you can go to an add-on therapy. Okay, the cyclosporine or whatever I'm using is not enough. Let's add this additional thing and think of this does the trick. And the reason it works differently is that it's basically a wound healing drug.

Speaker Change #122: instead of an inflammation drug so it's treating a different aspect of what's causing the dry eye.

Michael Rowe: They usually happen around the seasons and other things, and so this will, again, just be a different way of using a steroid, hopefully one that has a very low incidence of intraocular pressure spikes. If it's only 1% in the bottle, when you're using the oxygen, you're getting even less medication rolling around the eye.

Speaker Change #123: And then for clovetazole, I think the prescribers are very familiar with flare-ups. They usually happen around the seasons.

Michael Rowe: So we've removed that whole problem of people not wanting to pay and switches from the equation. And we can do that because we're being extremely efficient with the way that we're distributing. Through ourselves and through one e-farmacy partner who's well known in ophthalmology and to the optical offices as well. So I'm hoping that that happens within by the, you know, by the end of the summer, some time in September. But in any case, it's not like we're sitting here doing nothing.

Speaker Change #123: and other things. And so this will, again, just be a different way of using a steroid, hopefully one that has a very low incidence of intraocular pressure spikes.

Speaker Change #124: If it's only 1% in the bottle, when you're using the OptiJet, you're getting even less medication rolling around the eye. Maybe it's even better there, so it could offer some clinical benefit there too. Thanks.

Michael Rowe: Maybe it's even better there, so it could offer some clinical benefit there, too. Thanks. Yeah, very helpful. Thank you. We have reached the end of our question and answer session. I would like to turn the conference back over to Michael Rowe for closing comments.

Timothy Lugo: Got it. Thanks.

Speaker Change #125: Yeah, very helpful. Thank you.

Timothy Lugo: And on the timing of the Clubbedazole launch, are there any actual updates that you've had on that? Or is that you just delaying that because you previously said maybe August and you sort of haven't heard anything? No, Bren and I are talking with them weekly. This is all logistics and paperwork that we're going through. Not anything I'm terribly concerned about. It is something I'm not, I'm not dancing about because I would have liked it as soon as possible. But I am convinced that everybody is working as quickly as they can to get the product here. Okay, so does Formosa have their export license then?

Michael Rowe: We're out there pre-qualifying these offices. And that's the job of sales force to make sure those people are ready so that when it becomes available, they can turn the switch on and start using it immediately. Okay, that makes sense.

Timothy Lugo: No, they don't yet, and that's what we're working on. Okay, bye.

Speaker Change #125: We have reached the end of our question and answer session. I would like to turn the conference back over to Michael Rowe for closing comments.

Michael Rowe: Thank you, Sharon. And thanks to everyone on the call today for taking the time to be with us. You know, this is an exciting time to be with Eyenovia. Our advanced Gen 2 device is getting ready for production, while our chaperone study for pediatric progressive myopia is intended to be read out later this year. Upon a positive result, we look forward to moving micropine forward with the FDA. We have two FDA-approved products, one being actively promoted, and the other one we look forward to very, very soon. Both are very differentiated and well-positioned in the eye care space.

Michael Rowe: I encourage everyone to keep up to date with our progress on Eyenovia.com or through our social media links. And this concludes our call, and we look forward to talking with you again in November. Thank you. You may disconnect your lines at this time, and thank you for your participation.

Speaker Change #126: Unknown Executive, John Gandolfo, Michael Rowe,

Michael Rowe: Thank you, Sharon.

Michael Rowe: And then last question, you find, I guess, three dry eye collaborations in the last very recently. Can you talk a little bit about this strategy with these collaborations for dry eye? I guess you have one for flare ups, one's ajunctive and one's for chronic therapy. And had to think about those. Yes. Yeah. Thank you. So the first thing is that what's nice about this is that the three are not competitive with each other.

Timothy Lugo: Okay, thanks.

Michael Rowe: And thanks to everyone on the call today for taking the time to be with us.

Operator: As a reminder, it is star one on your telephone keypad if you would like to ask a question. Our next question is from Matthew Caulfield with H.C. Wainwright. Please proceed.

Matthew Caulfield: Great, thank you. Hi Michael and team.

Matthew Caulfield: So, my question was about dry eye and kind of thinking about comparisons to standard of care. How common is it to segment those dry eye patients currently? In other words, is there any risk prescribers would ultimately be more familiar with just the overall dry eye indication itself versus breaking out inflammation patients from those that need faster relief, for example? My understanding, at least, is that they're kind of all in one bigger bucket currently. Just wanted to kind of hear your perspective on that.

Speaker Change #127: You know, this is an exciting time to be with Inovia. Our advanced Gen 2 device is getting ready for production, while our chaperone study for pediatric progressive inovia is intended to read out later this year.

Michael Rowe: Thanks, Matthew. It's great to hear from you. I think if you spoke to a doctor who treats dry eye patients, he or she would honestly tell you that they are among the most difficult patients. Unknown Executive, Brian Dolliver, Leonard Yaffe, Eyenovia Inc., Unknown Executive, Brian Dolliver So, what I like about the SGN faster-working Restasis is that you'll get an answer as to whether this is going to work or not much faster than you would with the existing products out there, plus it's easier to use with the Opti-Jet.

Michael Rowe: What I like about the SendU product is that because it works differently, you can add it to anything. So, instead of switching, you can go to an add-on therapy. Okay, the cyclosporine or whatever I'm using is not enough; let's add this additional thing and think of this does the trick. And the reason it works differently is that it's basically a wound healing drug instead of an inflammation drug, so it's treating a different aspect of what's causing the dry eye. And then for clometazole, I think the prescribers are very familiar with flare-ups. They usually happen around the seasons and other things.

Michael Rowe: And so this will, again, just be a different way of using a steroid, hopefully one that has a very low incidence of intraocular pressure spikes. If it's only 1% in the bottle, when you're using the OptiJet, you're getting even less medication rolling around the eye. Maybe it's even better there, too. Thanks.

Matthew Caulfield: Yeah, very helpful. Thank you.

Michael Rowe: We have reached the end of our question and answer session. I would like to turn the conference back over to Michael Rowe for closing comments.

Speaker Change #127: Upon a positive result, we look forward to moving Micropyme forward with the FDA. We have two FDA-approved products, one being actively promoted, and the other one we look to very, very soon. Both are very differentiated and well positioned in the eye care space.

Michael Rowe: And thanks to everyone on the call today for taking the time to be with us. You know, this is an exciting time to be with Eyenovia. Our advanced Gen 2 device is getting ready for production, while our chaperone study for pediatric progressive Eyenovia is intended to read out later this year. Upon a positive result, we look forward to moving Micropine forward with the FDA. We have two FDA-approved products, one being actively promoted, and the other one we look forward to very, very soon.

Michael Rowe: Both are very differentiated and well positioned in the eye care space. I encourage everyone to keep up to date with our progress on Eyenovia.com or through our social media links. And this concludes our call, and we look forward to talking with you again in November.

Michael Rowe: You have the SGN product, which is a more rapidly acting cyclosporin. So they say that they work, I believe in four weeks and typically cyclosporin will take 12. So people get faster relief. So this is a way to take their product, which could be a foundation product. The first one you go in with dry eye and put it into the out to just system to make it easier to use. And also to differentiate their cyclosporin from other products that are out there.

Speaker Change #127: I encourage everyone to keep up-to-date with our progress on Ninovia.com or through our social media links.

Speaker Change #127: And this concludes our call, and we look forward to talking with you again in November.

Operator: Thank you. You may disconnect your lines at this time, and thank you for your participation.

Speaker Change #128: Thank you. You may disconnect your lines at this time, and thank you for your participation.

Michael Rowe: Then you have to send your product, which works with a completely different mechanism. But may need to be paired with something like a cyclosporin or a little photographs so that you get the benefit. Think of it as almost like the glaucoma model where half of the patients are on two different glaucoma meds. This could be in dry eye where half the patients are on two different dry eye products. So it could be an adjunct to almost anything.

Michael Rowe: So it's not competitive. And it's a really a unique way of looking at the marketplace. And then you have clovevethazole, which would be used for acute dry eye flare ups, which typically happen four or five times people that have dry eye where they get a flare up and they need something to knock down the inflammation. So it's a way of getting that also out in the market and differentiating it from the post surgical steroid.

Michael Rowe: So we looked at the three as almost like a good way to load up the basis and have a product at each face. And hopefully we'll be able to come to the plate and knock all of this home. Thank you. Thanks. Thanks, Michael. Thanks, Matt.

Camp Dolliver: Our next question is from Camp Dolliver with Brookline Capital Markets. Please proceed. Great.

John Gandolfo: Thank you and good evening. First question is the revenue numbers that you are booking right now. And how can we think about them in the context of the you're you're you're seeding the market for mid-Combie. And then presumably as we get later in the year, we should see a club at us all revenue. Yeah, I think that so we haven't given guidance yet. We will give guidance, obviously, once we launched a product.

John Gandolfo: But I think that ultimately the goal is to capture a 3 to 5% market share over a 12 to 15 month period for Climbettasaw. And Cap, in terms of timing, right right now is we don't we're traditionally in the market. Yeah, for mid-Combie, Climbettasaw, I think that you'll be seeing numbers in the fourth quarter for that because the reps are out there now again with the goal of they're going to hit 200 additional new offices for mid-Combie between now and the end of September.

John Gandolfo: And then they're responsible to getting to 500 Climbettasaw offices. Once the product is here so that would probably be September, October. So when you're going to actually see those revenues would be with the fourth quarter I would pursue. Right. Just to begin to this a little bit more because it's in a typical situation which you've explained clearly. Last quarter you had minimal revenue but cost of goods at the same level. This quarter you had negative gross margin.

John Gandolfo: What accounts for that difference? Yeah, so that's actually included in that cost of revenue is the one time right down of inventory to net realizable value of about $450,000. So if you take out that and that's a non-retiring expense. So if you take that out you would have seen the revenue and the cost of revenue basically be equal to each other as it happened in prior quarters. But we did take one charge associated with that which is included in that $490,000 number.

John Gandolfo: Great, thank you. And moving on to other things are probably a little more interesting. Looking at the dry-eye programs and admittedly this may be too early to speak to but are we looking at the same endpoints and registration trials or will they and there be some variations? Oh great question. You can actually they're all different from each other so it's a perfect question. So if we look at club edisol, that's a cute dry-eye, you're talking about two 15-day trials.

John Gandolfo: Those would be the shortest one. If you look at SGN cyclosporin because the safety profile of cyclosporin is well understood, you're looking probably at a 16-week trial in chronic dry. And again, I'm saying all of this, it has to be verified with the FDA, but this is my understanding. And if you look at Tenju's product with ours, that potentially could be the longest one with the actual one year plus a 16-week because they would have to establish, or we would have to establish long-term safety.

John Gandolfo: So, you know, in summary, again, Clobet is all 15 weeks, SGN probably six, 15 days, SGN probably 16 weeks, and Senju would likely be one year unless that data already exists somewhere and I'm not familiar with it.

John Gandolfo: That's very helpful. Thanks. And then, this is John. Let me just make a more point because you had raised something with the cost of revenues. That was a very good point. But the other thing I want to point out is this quarter includes a lot of expenses that are non-recurring relating to us by and back the rights from Bouchan Lone. So, when you look at it, we reported total operating expenses of $11.2 million.

John Gandolfo: But when you strip away the reacquisition of the rights as well as all of the non-cash charges and expenses related to the Bouchan Lone transaction, we expect going forward that our R&D and G&A will be a total of, you know, $6 to $6.1 million going forward. And I just want to make everybody's on the call aware of that. You know, if you look at it, that face value looks like we're increasing our expenses dramatically, but that's not the case at all.

John Gandolfo: It's really tied to that Bouchan Lone transaction. Thanks for that, John. Next, two more questions. The first one is the timeline for the Gen2 filing that you outlined in the press release and the discussion. That's unchanged, correct? That we're probably looking at an approval in 2026. Yeah, we're actually manufacturing. Bren, you can correct me. We're manufacturing in the fourth quarter, correct? Yes, we are producing registration batches in the fourth quarter of this year to put on that stability program to support the filing with the FDA. So your timeline is correct. Yeah, so that would be 12 months from there, we can file the NDA. That's NDA.

John Gandolfo: Great, thanks. And the last question pertains to the cash runway. Are we still looking at the runway into the end of this year, or is there any different now? No, I think that in terms of our expenses, that we're still looking at it towards the end of this year. We do have access to capital today if we wanted it, as well as I mentioned in my own remarks, we are looking at a lot of different structures, whether it be coordinated, that's convertible, that might add capital as well. But I think that's still accurate.

Unknown Executive: Thanks so much.

Tim Lugo: Our next question is from Tim Lugo with William Blair, please proceed. There you go, it says lock on on for Tim. Thanks for taking the questions. On the mid-compete adoption, I was just wondering if you can provide more color on the sort of the cadence of that throughout the second quarter because that obviously sounds like it grew decently and is growing it perhaps even quicker in Q3. So maybe it's the cadence through Q2 and now we should expect that to track into Q3 and that is Q3 going to be a steady state or will it keep growing from there?

Tim Lugo: And related to that on the centers that haven't adopted yet, maybe the ones that you've approached would have an adopted it. Can you talk about why if they haven't adopted it? And then one other follow up on the dry eye collaborations. As you noted, you sort of have three covering or three areas of treatment. Should we think of that as sort of maybe no more dry ideals in the near term or are you still open to and that's more importantly, a partner is still open to developing or partnering from multiple products in the same space?

Michael Rowe: Well, let me take a second one first and thank you Tim. The dry eye collaboration has that this problem is for a non-exclusive. So if you know with some on that make sense for us as a company, we would certainly consider that. So we haven't shut any doors. And what I'm hoping that people will see and potential partners will see is that interest in our technology is picking up as a great way to extend the runway for things that might have a short patent life or to be more competitive in this market.

Michael Rowe: For your first question on mid-convy, it's funny that you're asking this because I just came back personally from an office that we trained about a week ago because I wanted to see what was going out there and I think that the reason our cadence is picking up is that our sales force is in place and they are figuring out how to do this. The general interest and acceptance of mid-convy is high.

Michael Rowe: What happens though is that people are used to using eyedrops. They've been around for 150 years. So the way it works is you bring mid-convy into the office. You find a champion, a tech, for example, who really likes the product and wants to use it first. And he or she is the one that introduces it within the practice and soon everybody else gets used to it as well and finds all the reasons that it's superior to the way that they're doing things now.

Michael Rowe: The issue is that that takes time. So the way the sales process works is ourselves representatives need to get into the office. Once they're there, they have to do a quick training of everybody to introduce it because it is completely different from anything they've seen before. They will stick around for a while to make sure everybody is using it correctly and doesn't have any questions. And then over the next couple of weeks, they check back in to see how everything is.

Michael Rowe: And I've seen this time and time again that you get that one person or two people in there who really like it and all of a sudden you have a half dozen and all of the techs who like it soon after that. So what we've learned is we have to have patience and we have to do it right. And then once we do, that's how we get the re-orders. The people that we found that you don't go to is you don't go into offices where they are entirely driven by, I just want to get these patients in and out, in and out, like a machine.

Michael Rowe: And that's not our customer. Our customer is the one that cares about the patient experience and also cares about the other benefits of the product. For example, when I was in that office, they had a number of elderly patients. It was a glaucoma practice. And the elderly patients can't tilt their heads back to have these drops put in their eyes. So it was especially helpful to use mid-convy with them because they could look straight ahead for the dilation process. And that was something that I did not even consider until I actually saw it. So I'm very encouraged by what we've seen. And I think this is the right way to do this.

Michael Rowe: It reminds me of the old triad, no like it commercials. I'm because I'm confident I'll try it, and they'll like it, on the timing of the club bed as I'll launch. Are there like actual updates that you've had on that or is that you just delaying that because you've previously said maybe August and you sort of haven't heard anything? We know Bren and I are talking with them weekly. This is all logistics and paperwork that we're combing through.

Michael Rowe: Not anything I'm fairly concerned about. It is something I'm not I'm not dancing about because I would have liked it as soon as possible, but I am convinced that everybody is working as quickly as I can to get the product here. Okay, so it does almost have the export license then. No, they don't yet. That's what we're working on. Okay, thanks.

Unknown Executive: Thank you.

Matthew Caufield: As a reminder to star one on your telephone keypad if you would like to ask a question, our next question is from Matthew Caufield with HC Wayne, right? Please proceed. Great. Thank you. Hi, Michael and team. So my question was on dry eye and kind of thinking about comparisons to standard of care. How common is it to segment those dry eye patients currently? In other words, is there any risk for scribers would ultimately be more familiar with just the overall dry eye indication itself versus breaking out inflammation patients from those that need faster relief, for example. My understanding at least is that they're kind of all in one bigger bucket currently just wanted to kind of hear your perspective there. Thanks, Matthew. Great to hear from you.

Michael Rowe: I think if you spoke to a doctor who treats dry eye patients, he or she will honestly tell you that they are among the most difficult patients to treat because they are in a lot of discomfort and not, you know, there's nothing that works for everybody. And in fact, I think I saw some research that even with recesses fewer than half of the patients actually are satisfied with the relief that they get.

Michael Rowe: So what happens now is they might try one drug or they might try the other and when it doesn't work, they'll switch to another drug. So what I like about the SGN faster working recesses is that you'll get an answer as to whether this is going to work or not much faster than you would with the existing products out there plus it's easier to use with the object. What I like about the send you product is that because it works differently, you can add it on to anything.

Michael Rowe: So instead of switching, you can go to an ad on therapy, okay, the cyclosporin, or whatever I'm using is not enough. Let's add this additional thing and think of this does the trick. And the reason it works differently is that it's a basically a wood healing drug instead of an inflammation drug. So it's treating a different aspect of what's causing the dry eye. And then for cloveathers all I think the prescribers are very familiar with flare ups.

Michael Rowe: They usually happen around the seasons and other things. And so this will again just be a different way of using a steroid, hopefully one that has a very low incidence of intraocular pressure spikes. If it's only 1% in the bottle, when then when you're using the oxygen you're getting even less medication rolling around the eye. Maybe it's even better there so it could offer some clinical benefit there too. Thanks. We have reached the end of our question and answer session.

Michael Rowe: I would like to turn the conference back over to Michael Rowe for closing comments. Thank you, Sharon. And thanks to everyone on the call today for taking the time to be with us. You know, this is an exciting time to be with I know of you. Our advanced jet into the vice is getting ready for production. While our shaperone study for pediatric progressive is intended to read out later this year. Upon a positive result, we look forward to moving Mike for pie forward with the FDA.

Michael Rowe: We have two FDA approved products, one being actively promoted and the other one we look to very, very soon. Both are very differentiated and well-positioned in the eye care space. I encourage everyone to keep up to date with our progress on I know via dot com or through our social media links.

Unknown Executive: And this concludes our call and we look forward to talking to you again in November. Thank you. You made disconnect your lines of this time and thank you for your participation. Thank you.

Q2 2024 Eyenovia Inc Earnings Call

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