Q4 2023 Protagenic Therapeutics Inc Earnings Call

Okay.

Operator: Greetings. Welcome to the Protagenic Therapeutics Q4 and Fiscal Year 2023 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 will now turn the conference over to your host, Alexander Arrow. You may begin.

None: Greetings and welcome to the Proto Genic Therapeutics fourth quarter and fiscal year 2023 earnings call. At this time, all participants are in a listen only mode.

None: <unk> and answer session will follow the formal presentation.

None: One should require operator assistance during the conference. Please press Star zero on your telephone keypad. Please note. This conference is being recorded.

I will now turn the conference over to your host Alex Arrow you may begin.

Alexander Arrow: Thank you very much. Good afternoon, everyone. I'd like to welcome you to Protagenic Therapeutics earnings call to review our Q4 and fiscal year 2023 year-end operating results. Participating on the call today with me is our Executive Chairman, Dr. Garo Armen, our Chief Operating Officer, Dr. Andrew Slee, and our Chief Medical Officer, Dr. Robert Stein. I'd like to thank them and each one of you for your time and commitment to Protagenic Therapeutics. I'm the company's Chief Financial Officer, Alexander Arrow. 2023 was a pivotal year in the history of our company. During 2023, we began our first-ever clinical trial of our lead product, known as PT00114, a drug candidate that has the potential to benefit millions of patients suffering from depression, chronic anxiety, PTSD, or drug addiction.

Alex Arrow: Thank you very much good afternoon, everyone I'd like to welcome you to project Therapeutics earnings call to review, our fourth quarter and fiscal year 2023 year end operating results participating on the call today with me is our executive Chairman Dr. Garo Armen, our Chief operating officer, Dr. Andrew Suite, and our Chief Medical Officer, Dr. Bob Stein I'd like to thank them and each one of you for your time and.

Alex Arrow: Commitments project Therapeutics, I'm, the company's Chief Financial Officer, Alexander Trop.

Alex Arrow: 2023 was a pivotal year in the history of our company during 2023 we began our first ever clinical trial of our lead products known as pizza users grow and look for a drug candidate that has the potential to benefit millions of patients suffering from depression chronic anxiety PTSD for drug addiction.

Alexander Arrow: On today's call, we'll be providing a detailed discussion about the significance of this clinical trial and an outlook for what to expect specifically in 2024. Before we begin those remarks, I'd like to note that the following commentary will include some forward-looking statements that are subject to risks and uncertainties that may cause actual results to differ materially from those that we forecast. Forward-looking statements include statements regarding the field of neuroactive peptides and the potential for therapies that have a quantifiable effect on anxiety, depression, PTSD, or addiction. The expectation that TCAPs will become accepted treatment regimens for neurologic disease conditions and potentially replace less effective antidepressant, anti-anxiety, or anti-addiction therapies as the standard of care. The development, regulatory, and commercialization efforts and the timeliness of the company's PT00114 drug candidate or any licensees or partners.

Alex Arrow: On today's call, we'll be providing a detailed discussion about the significance of this clinical trial and an outlook for what to expect specifically in 2024.

Alex Arrow: Before we before.

Alex Arrow: Before we begin those remarks I'd like to note that the following commentary will include some forward looking statements that are subject to risks and uncertainties that may cause actual results to differ materially from those forecast forward. Looking statements include statements regarding the field of neuropathy peptides and the potential for therapies that have a quantifiable effect that anxiety depression, and PTSD or addiction.

Alex Arrow: Expectation that T caps will become accepted treatment regimens for neurologic disease conditions, and potentially replace less effective antidepressants anti anxiety or anti addiction therapies as the standard of care.

Alex Arrow: The development regulatory and commercialization efforts and the timeliness of the Companys pizza users or one of them for drug candidate or any licensees or partners.

Alexander Arrow: The potential for our single neuropeptide drug candidate to reduce the severity of disorders it is being targeted to treat. The potential for the company to bring in funding, either by monetizing some of its potential future royalty streams or executing a new strategic collaboration or by selling stock at a price per share that is higher than current levels, and other forecasts of future events. These risks and uncertainties include, but are not limited to, those identified under the heading Risk Factors in our annual report on Form 10-K for the year ended 31 December 2023, which is being filed today with the SEC. Now I'd like to introduce you to Dr. Garo Armen, the company's Executive Chairman, to make opening remarks and frame today's discussion.

Alex Arrow: The potential for our single neural peptide drug candidate to reduce the severity of disorders that are being targeted to treat.

Alex Arrow: The potential for the company to bring in funding either by monetizing some of its potential future royalty streams or excuse me, a new strategic collaboration or the selling stock at a price per share that was higher than current levels and other forecast of forecast of future events.

Alex Arrow: These risks and uncertainties include but are not limited to those identified under the heading risk factors in our annual report on Form 10-K for the year ended December 31, 2023, which is filed with being filed today with the SEC.

Speaker Change: And now I'd like to introduce you to Dr. Garo Armen, the Companys executive chairman to make opening remarks and frame today's discussion.

Alexander Arrow: After the discussion of our clinical progress and outlook, I will come back and review our financial performance in Q4 and fiscal year 2023. Garo will open the call up to your questions. Garo?

Garo Armen: After the discussion of our clinical progress and outlook I will come back and review our financial performance in Q4 and fiscal year 'twenty three and then we'll open the call up to your questions Daryl.

Garo Armen: Daryl.

Garo Armen: Thank you very much, Alex. I'm excited to share with you the progress that we've made with Protagenic Therapeutics in 2023, as we transform the company into a clinical stage company with the initiation of our first in-human trial of PT00114. This drug candidate, which is an analog of the naturally occurring neuropeptide, teneurin C-terminal associated peptide, otherwise known as TCAP, works through a novel mechanism of action distinct from currently available treatments for neuropsychiatric disorders. PT00114 precisely targets specific neuronal peptides or pathways involved in the stress response and emotional processing, with the potential to restore healthy brain function and provide relief to patients suffering from anxiety, possibly depression, PTSD, and addiction. By working in harmony with the brain's innate regulatory systems, PT00114 may deliver meaningful improvements in symptoms and quality of life with fewer side effects compared to existing medications.

Garo Armen: Thank you very much Alex I'm excited to share with you the progress that we've made with Protogenic therapeutics in 2023.

Daryl: As we transform the company into a clinical stage company with the initiation of our first in human trial of P. T 0014.

Daryl: This drug candidate, which is an analog of the naturally occurring neuropeptide 10 Union when she terminal associated peptide otherwise known as T cap.

Daryl: Works through a novel mechanism of action distinct from currently available treatments for neuro psychiatric disorders.

Daryl: P. T 0011 for precisely target specific neuron old path peptides or pathways involved in the stress response and emotional processing.

Daryl: With the potential to restore heavily brain taxes, a healthy brain function and provide relief to patients suffering from anxiety.

Possibly depression, PTSD and addiction.

Daryl: By working in harmony with the brain's innate regulatory systems P. T 00114 may deliver meaningful improvements in symptoms and quality of life with fewer side effects.

Daryl: <unk> to existing medications.

Garo Armen: Of course, the field knows a lot of the limitations of existing medications. As you will hear in more detail from Dr. Stein and Dr. Slee, our extensive preclinical research provides a robust foundation for the clinical development of our agent. We believe this groundbreaking therapy could transform the treatment landscape and bring new hope to millions of people, as Alex alluded to, living with the burden of undertreated and debilitating mental health conditions. I'd now like to introduce Dr. Robert Stein, the company's Chief Medical Officer, to share with you more details. Bob?

Daryl: And and of course, the field knows a lot of the limitations of existing medications.

Daryl: As you will hear in more details from Dr Stein and back to sleep.

Daryl: Our extensive preclinical research provides a robust foundation for the clinical development of our agent.

Daryl: We believe this groundbreaking therapy could transform the treatment of landscape and bring new hope to millions of people of as Alex alluded to.

Daryl: Living with the burden of Undertreated and debilitating mental health conditions.

Speaker Change: Now like to introduce Dr. Bob Stein, the company's Chief Medical Officer.

Bob Stein: To share with you more details Bob.

Bob Stein: Yeah.

Robert Stein: Hello, everyone. In the quest to address the complexities of neuropsychiatric disorders, our focus at Protagenic Therapeutics has been to delve deeply into the mechanisms that underpin our responses to stress and its profound impact on mental health. Central to our efforts is PT00114, a synthesized analog of teneurin C-terminal associated peptide, or TCAP, discovered through the pioneering work of our Scientific Founder, Dr. David Lovejoy. This groundbreaking therapy acts broadly in the brain with notable effects in the amygdala, the critical brain region involved in emotional processing and stress response, marking a significant advance over alternative therapies. Our journey has been guided by rigorous scientific inquiry, revealing that the stress-induced maladaptations in brain function extend beyond mere symptoms to the very core of neuropsychiatric conditions. The preclinical data on PT00114 offer compelling evidence of its capacity to directly modulate brain responses to stress, including modulating limbic and amygdala activity.

Bob Stein: Hello, everyone.

In the quest to address the complexities of neuropsychiatric disorders are focused at photogenic therapeutics has been to delve deeply into the mechanisms that underpin our responses distress and its profound impact on mental health.

Bob Stein: Central to our efforts is P. T 00114, synthesize analog up 10 yards terminals associated peptide or T. Kat.

Bob Stein: Discovery through the pioneering work of our scientific founder Dr. David Lovejoy.

Bob Stein: This groundbreaking therapy ask broadly in the brain with notable effects in the amygdala. The critical brain regions involved an emotional processing and stress response, marking a significant advance over all partnerships therapies.

Bob Stein: Our journey has been guided by a rigorous scientific inquiry, revealing that the stress induced maladaptive missions in brain function extend beyond mere symptoms to the very core of neuropsychiatric conditions.

Bob Stein: The preclinical data on P. T 00114 offer compelling evidence of its capacity to directly modulate brain responses distress, including modulating limbic an enabler activity.

Robert Stein: This targeted approach not only promises to mitigate the symptoms of anxiety, depression, PTSD, and addiction, but also aims to address the underlying causes of these conditions by restoring neuronal and behavioral balance. Unlike broad-spectrum therapies that affect the brain in a more generalized manner, PT00114's precise action on specific neural pathways represents a refined strategy. It holds the potential to improve therapeutic outcomes by engaging with the brain's natural mechanisms for managing stress responses and emotion. This specificity suggests greater efficacy with fewer side effects, aligning closely with the evolving needs of patient care and mental health. Now that we have advanced PT00114 into clinical development, the exciting path forward presents a wide range of opportunities. Our preclinical data support the potential of PT00114 to treat anxiety, depression, post-traumatic stress disorder, drug addiction, and even conditions such as neurodegeneration.

This targeted approach not only promises to mitigate the symptoms of anxiety depression, PTSD and addiction, but also aims to address the underlying causes of these conditions by restoring neuronal behavioral balanced.

Bob Stein: Unlike broad spectrum therapies that affect the brain in a more generalized manner G. T 00114 as precise action on specific neural pathways represents a refined strategy.

Bob Stein: It holds the potential to improve therapeutic outcomes.

Bob Stein: Engaging with the brain's natural mechanisms for managing stress responses and emotion.

Bob Stein: This specificity suggest greater efficacy with fewer side effects aligning closely with the evolving needs of patient care and mental health.

Bob Stein: Now that we have advanced P. P 00114 into clinical development exciting path forward presents a wide range of opportunities.

Bob Stein: Our preclinical data support the potential of P. P 00114 to treat anxiety depression post traumatic stress disorder.

Doug addiction, and even conditions such as nerds generation.

Robert Stein: Our challenge has been to focus and prioritize the indications we explore. The depth of our preclinical insights, underscored by a nuanced understanding of TCAP's role in stress regulation, sets a solid foundation for our clinical trials. Collaborating with experts like Dr. Maurizio Fava, Harvard University's Psychiatrist-in-Chief, and leveraging robust pharmacological and safety profiles, we have initiated clinical trials that are poised to explore PT00114's potential in selected neuropsychiatric disorders. The implications of our work extend beyond the immediate horizon of drug development. They invite a reevaluation of how we understand and treat neuropsychiatric disorders, emphasizing the need for interventions that tap into and amplify the body's own regulatory systems. In closing, our commitment to uncovering the therapeutic potential of PT00114 is unwavering. This venture is not just about advancing a promising drug candidate.

Bob Stein: Our challenge has been to focus and prioritize the indications we explore.

Bob Stein: The depth of our preclinical insights.

Bob Stein: Underscored by a nuanced understanding of <unk> role in stress regulation sets, a solid foundation for our clinical trials collaborating with experts like Doctor merits Youll Saba, Harvard University's psychiatrist in chief and leveraging a robust pharmacological and safety profiles, we have initiated.

Bob Stein: Clinical trials that are poised to explore a P. T 001 month four's potential and selected neuro psychiatric disorders.

Bob Stein: The implications of our work extends beyond the immediate horizon of drug development.

Bob Stein: Invite a reevaluation of how we understand and treat neuropsychiatric disorders, emphasizing the need for interventions that tap into and amplify the body's own regulatory systems.

In closing our commitment on covering the therapeutic potential of P. T 001 month for his unwavering.

Bob Stein: This center is not just about advancing a promising drugs.

Robert Stein: It's about fostering a deeper understanding of mental health and offering hope to the many people afflicted by stress-related conditions. Thank you for your attention. I will be happy to take any questions you might have about our work at the end of the formal session. Now I'd like to introduce you to my colleague, Dr. Andy Slee, Protagenic's Chief Operating Officer. Andy?

Bob Stein: It's about fostering a deeper understanding of mental health and offering pulp to the many people afflicted by stress related conditions.

Thank you for your attention.

None: I will be happy to take any questions you might have about our work.

None: At the end of the formal session.

Now I'd like to introduce you to my colleague Dr. Andy sleeves.

Dr. Andy: Photogenic, She was chief operating officer, Andy Thank.

Andrew Slee: Thank you very much, Bob. I'm here today as part of a team deeply committed to transforming the way we approach mental health treatment. Our work with PT00114 provides an unprecedented opportunity to bring best-in-class treatment to people suffering from a broad range of mental disorders. We have demonstrated preclinically that TCAP is both potent and safe, and that it has beneficial effects to combat the negative effects of stress. It also has, unlike other CNS acting agents, a very rapid onset, and also has a long duration, even after a single dose. We have shown that TCAP is effective after injection, either subcutaneously or intravenously. That it can be used after placement under the tongue or delivery intranasally. Unlike benzodiazepines such as Valium, it doesn't cause sedation. Furthermore, it does not seem to impact weight gain or impact libido.

Andy: Thank you very much Bob.

Andy: I'm here today as part of a team deeply committed to transforming the way we approach mental health treatment.

Andy: I worked with P. T shares here one month for provides unprecedented opportunity to bring best in class treatment to people suffering from a broad range of mental disorders.

We have demonstrated pre clinically that <unk> is.

Andy: Both potent and safe and that it has beneficial effects to combat the negative effects of stress.

Andy: It also has unlike other CNS acting agents.

Andy: Rapid onset and also has a long duration, even after a single dose.

Andy: We have shown that Chi campus effective after injection, either subcutaneously or intravenously.

Andy: And that it can be used.

The placement under the tongue or delivery inter nasally.

Andy: Unlike benzodiazepine such as valium, it doesn't cool sedation. Furthermore, it does not seem to impact weight gain or impacts libido.

Andrew Slee: We have demonstrated with other classic agents that it does not have the addictive potential of fentanyl or other type agents, and that was carried out by an independent CRO. In unstressed animals, it can be delivered by a whole variety of routes, as I said, and this gives us an opportunity to ensure that we have compliance with patients. Our synthetic analog, PT00114, actually represents a convergence of nature's wisdom and, along with, we'll take some credit, a little bit of scientific innovation. This peptide is actually conserved across a vast evolutionary landscape, spanning from nematodes to humans. This suggests it plays an integral role in the CNS function, potentially without eliciting toxicities as seen with other agents that are commonly given for mental disorders.

Andy: And we have demonstrated.

Andy: With other classic agents that he does not have the addictive potential.

Andy: Fentanyl or other type agents and that was carried out by an independent CRM.

Andy: In unstressed animals.

Andy: Can be delivered by a whole variety of blue chip, but he said and this gives us an opportunity.

Andy: To ensure that we have compliance with patients.

Andy: Synthetic analog P. T 001 month for actually represents a convergence of nature wisdom and along with it takes them a little bit of scientific innovation.

Andy: Peptide is actually conserved across a best evolutionary landscape spanning from NEMA, Joe just to humans and this suggests it's an integral it.

Andy: An integral role in CNS function potentially without eliciting toxicities.

Seen with other agents that are commonly given for many disorders.

Andrew Slee: Our approach has been grounded in an extensive GLP toxicological study, as well as preclinical studies, and we have used both rodents and non-human primates, and we have found that we have a very broad therapeutic window. This provides us a solid foundation for moving our application into humans. As we prepare to test this agent in patients, we are focused on understanding its pharmacology, particularly with focus on developing useful transitional approaches to facilitate its movement from bench to bedside. We have evaluated the effects required for an efficacious dose given by various routes and different dosing schedules so that we can optimize our clinical development path. The operational challenge and our solution has been to navigate the complex transitional landscape from bench to bedside. The administration routes are meticulously selected, as I said, to enhance compliance and accessibility, ensuring that the therapeutic potential of TCAP is fully realized.

Andy: Our approach has been grounded in an extensive G. L. P. Toxicological studies as well as preclinical studies and we've used both rodents and nonhuman primates and we have found that we have a very broad therapeutic window. This provides us a solid foundation for a.

Andy: Moving our application into humans.

Andy: As we prepare to test this agent in patients we have focused on understanding its pharmacology, particularly with focus on developing useful translational approaches to visit.

Andy: This movement from bench to bedside.

We've evaluated these effects required for an efficacious dose given by various fruits.

Andy: And different dosing schedules, so that we can optimize our clinical development path.

Racial challenge and our solution has been to navigate the complex transitional landscape from bench to bedside.

Andy: The administration route to meticulously execute and as I said to enhance compliance and accessibility ensuring that the therapeutic potential of <unk> is fully realized.

Andrew Slee: We're excited to explore the effects of PT-00114 in patients, anticipating that we will be able to recapitulate the very promising activities we have seen in our preclinical models. In the realm of clinical development, we are currently under evaluation in SAD, which is single ascending dose, and MAD, multiple ascending dose studies involving normal, healthy volunteers. These studies are crucial as they help us delineate the efficacious dosing regimen that will be required in humans. Unlike many current drugs that treat mental illness, the dose response of PT-00114 is actually well-defined, and the drug is very safe. Therefore, the challenges in navigating the delicate balance between efficacy and safety, as seen with other treatments, appears not to be that problematic with PT-00114. The progress in these clinical trials is not just measured by its potential, but a testament to our rigorous approach and a patient-centric development.

Andy: We're excited to explore the effects of P. T zero zero them on foreign patients anticipating that we will be able to recapitulate very promising activities, we have seen in our preclinical models.

Andy: In the realm of clinical development. We are currently under evaluation and sat which is a single ascending dose and mad multiple ascending dose studies involving normal healthy volunteers. These studies are crucial as they help us delineate the efficacious dose regimen that will be required in humans.

Andy: Unlike many current drugs that treat mental illness, the dosage bonds or P. T zero as you are well known for its actually will define and the judges very safe. Therefore, the challenges navigating the delicate balance between efficacy and safety seen with other treatment appears not to be that problematic P. T zero zero.

Andy: A month for the.

Andy: The progress in these clinical trials not just measured by its potential, but it's a testament to our rigorous approach and a patient centric development.

Andrew Slee: Our insights into the molecule's performance in both acute and chronic models of stress underscore a significant leap over traditional small molecule CRF antagonists. Unlike these antagonists with CRF, standing for corticotropin-releasing factor, PT-00114 maintains its activity across a range of stress-induced conditions that are relevant in animal models. Whereas the small molecule CRF antagonists do not perform in chronic models, PT-00114 does. We found that both PT-00114 and direct CRF blockers work in animal models, as I said, but the distinction is that we work in a chronic distress model. In patients, it's the chronic stress conditions, not necessarily the acute stress condition, that drives the disorders of mental health, like anxiety and depression. This important difference that we have discovered in the efficacy of PT-00114 compared with direct CRF blocking has reassured us that we're bringing forward a very important new medicine.

Andy: Insights into the molecules performance in both acute and chronic muddled distress underscore a significantly over traditional small.

Andy: Molecule CRF antagonist.

Unlike these antagonist with tariffs Sunday for Corticotropin, releasing factor P. T. Z was there 114 maintained its activity across a range of stress induced conditions that are relevant in animal models and whereas the normal the small molecule CRF antagonist to nonperforming.

Andy: Form.

Andy: Chronic models P. T 001 month four does.

Andy: Yeah.

It blocks.

Andy: Yeah, Dan we found that those picci's theres, there along with foreign direct CRF blockers work in animal models as I said, but the distinction is that we worked in a chronic distress model and in patients. It's a chronic stress conditions not necessarily the acute stress to meet a condition that.

Andy: Drives the disorders of mental health like anxiety and depression.

Andy: This important difference that we have discovered in the efficacy of P. T 00114, compared with direct CRF blocking us reassurance that we're bringing forward a very important new medicine as.

Andrew Slee: As we continue on this path, the strides we make in clinical characterization of the effects of this agent in selected mental disorders are pivotal. They represent our commitment to reshaping the landscape of the treatment of anxiety, depression, PTSD, as well as addiction. We thank you for your support and our belief in our mission. Together, we are stepping into a new era of mental health treatment marked by innovation, compassion, and an unwavering commitment to improving patients' lives. With that, I thank you and turn it over to Alex Arrow.

Andy: As we continue on this path the strides we are making technical characterization of effectiveness agents selected mental disorders are pivotal they represent our commitment to reshaping the landscape for the treatment of anxiety depression, PTSD as well as addiction. We thank you for your support.

Andy: And our belief in our mission and together, we are stepping into a new era of mental health treatment, Mark by innovation compassion and unwavering commitment to improving patients' lives.

Andy: Thank you and turn it over to Alex Arrow.

Alexander Arrow: Thank you very much, Andy. As you can see from our clinical trial status, the company made operational progress towards its primary objective of developing and commercializing PT00114 during fiscal year 2023, particularly during the Q4. Our financial results reflect an increase in R&D spending to pursue that goal. In the Q4 of 2023, we spent $1.0 million on R&D, which is an increase of 301% over the $258,000 R&D that we spent in the Q4 of 2022.

Thank you very much Andy as you can see from our clinical trial status. The company made operational progress towards its primary objective of developing and commercializing P. T.

Alex Arrow: Going forward during fiscal year, 2023 particularly during the fourth quarter.

Alex Arrow: Our financial results reflect an increase in R&D spending to pursue that goal.

Alex Arrow: In the fourth quarter of 2023, we spent 1.1 million on R&D, which is an increase of 301% over the 258000 R&D that we spent in the fourth quarter of 2022.

Alexander Arrow: This significant increase in R&D expenditures was entirely due to the clinical trial that is now in progress, which commenced just as Q4 was starting. Our general and administrative spend for Q4 of 2023 was just $201,000, which is down 50% from our R&D spend the comparable quarter a year ago, primarily because we issued no stock options during the quarter, and we had no non-cash compensation or minimal non-cash compensation expense during this quarter, as we previously had in Q4 of 2022. As for sales and marketing, we spent none in either Q4 of 2023, nor Q4 of 2022, as we're not on the market yet. Overall, our net loss for Q4 was $1.2 million, compared to a net loss of $656,000 in the year ago quarter.

Alex Arrow: This significant increase in R&D expenditures was entirely due to the clinical trial that is now in progress, which commenced justice Q4, it was starting.

Alex Arrow: Our general and administrative spend for the fourth quarter 'twenty trades, where it was just 201000, which is down down 50% from our R&D spend the comparable quarter a year ago.

Alex Arrow: Primarily because we issued no stock options during the quarter and we had no noncash compensation or minimal noncash compensation expense during the quarter as we previously had in the fourth quarter of 2022.

Alex Arrow: As for sales and marketing we spend on in either the fourth quarter of 'twenty, three or nor the fourth quarter of 'twenty. Two is we're out in the market overall.

Alex Arrow: Overall, our net loss for Q4 was $1 2 million compared to a net loss of 656000 in the year ago quarter.

Alexander Arrow: For the full year of 2023, we spent $3.3 million in R&D, which is a bit more than double, up 109% from the $1.6 million we spent on R&D in the full year of 2022. Our full year G&A of $1.2 million was similar to the quarter, down almost 40% from the amount we spent in the year ago period, again, primarily because we had only minimal stock-based compensation expense as nearly all of the issued stock options were fully vested at that point. For the full year net income, we lost $4.5 million, which is 27% more than we had lost in 2022, driven primarily by our higher R&D spend because of our clinical trial activities. As for our cash, we ended the year with $4.1 million in cash and cash equivalents, which is down from the $8.0 million we had as of 31 December 2022.

Alex Arrow: For the full year of 'twenty, three we spent $3 3 million in R&D, which is a bit more than double up 109% from the $1 6 million, we spent on R&D and our full year 2022 are.

Alex Arrow: Full year G&A of $1 2 million was similar to the quarter.

Alex Arrow: Down almost 40% from the amount we spent in the year ago period again, primarily because we had only minimal stock based compensation expense as.

Alex Arrow: Nearly all of the issued stock options were fully vested at that point for the full year net income, we lost $4 $5 million, which is 27% more than we had lost in 2022, driven primarily by a higher and higher R&D spend because of our clinical trial activities.

Alex Arrow: As for our cash we ended the year with $4 1 million in cash and cash equivalents, which is down from the 8.1 billion that we had and as of December 31, 22, we believe that our current cash reserves are sufficient to fund all of our phase one clinical trial.

Alexander Arrow: We believe that our current cash reserves are sufficient to fund all of our phase I clinical trial. With that, I would like to turn the call back over to Garo.

Alex Arrow: With that I would like to turn the call back over to Daryl.

Garo Armen: Thank you very much, Bob, Andy, and Alex. In closing, I want to underscore the importance of having transitioned Protagenic into a clinical stage biotech company. The novel mechanism of action of PT00114, which Bob and Andy described very nicely, coupled with the promising pharmacological and safety profile seen in preclinical studies, gives us a great deal of confidence in its potential therapeutic activity. As we look ahead to 2024, our focus will be on efficiently executing the phase I program and preparing for proof of concept efficacy studies in anxiety, depression, and other stress related conditions. As you heard from Bob and Andy, we are committed to bringing this potential breakthrough treatment to patients as expeditiously as possible. This is an exciting time for our company as well as for patients.

Daryl: Thank you very much Bob Andy and Alex in closing I want to underscore the importance of having transitioned.

Daryl: Part of organic into a clinical stage biotech company.

Daryl: The novel mechanism of action or P. T 00114, which Bob and Andy described very nicely, coupled with the promising pharmacological and safety profile seen in preclinical studies.

It gives us a great deal of confidence in its potential therapeutic activity.

Daryl: As we look ahead to 2024.

Daryl: Our focus will be on efficiently executing the phase one program.

Daryl: In preparing for proof of concept efficacy studies and anxiety there.

Daryl: And I just transfer related conditions.

Daryl: As you heard from Bob and Andy we are committed to bringing this potential breakthrough treatment to patients as expeditiously as possible.

Daryl: This is an exciting time for our company as well as for patients.

Garo Armen: Of course, the mental health tragedy has been exacerbated with the onset of COVID and other conditions globally. On behalf of the entire leadership team, I want to thank all of you for your ongoing support of our mission. Together, I believe we can make a profound difference for patients and families affected by neuropsychiatric disorders. We look forward to further updates as we progress our programs. Our agent is progressing in the clinic as planned, and our plans for advancing this promising drug candidate remain absolutely unwavering, as you heard. Thanks again for your time and your participation in today's call, and I think now we are ready for any questions that you may have.

Daryl: And of course, the mental health tragedy has been exacerbated with the onset of Covid and other conditions globally.

None: On behalf of the entire leadership team I want to thank all of you for your ongoing support of our mission.

None: I believe we can make a profound difference for patients and families affected by neuro psychiatric disorders.

None: We look forward to it.

None: Further updates as we progress our programs.

None: Our agent.

None: He is progressing in the clinic as planned and our plans for advancing this promising drug candidate.

None: Main.

Absolutely unwavering as you've heard.

None: Thanks again for your time and your participation in today's call and I think now we are ready for any questions. They may have.

Operator: Thank you. At this time, we will be conducting a question and answer session. 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'd 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. One moment, please, while we poll for questions. Once again, please press star one if you have a question or a comment. Our first question comes from William Wood with B. Riley Securities. Please proceed.

None: Thank you at this time, we will be conducting a question and answer session. 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'd like to remove your question from the queue for participants using speaker equipment, it may be necessary to pick up here.

None: A handset before pressing the star keys, one moment. Please while we poll for questions. Once again. Please press star one if you have a question or comment.

None: Our first question comes from William Wood with B Riley Securities. Please proceed.

William Wood: Thank you so much for taking our questions and congratulations on a very nice quarter and year. We're just curious about, two from us, curious about the timeline for the readout of your SAD and MAD studies, if we should be expecting those together, combined or apart. Then what are the next regulatory steps that you have for moving forward into your phase II studies?

Thank you so much for taking our questions and congratulations on the very nice quarter and year.

William Wood: Just curious about it too from us I'm curious about the timeline for the readout of your sad and Mad studies, if we shouldn't be expecting those two.

William Wood: Together, our combined or apart and then what are you what are the next regulatory steps that you have for moving forward into your phase III studies.

Garo Armen: I'll ask Alex to address the first question, and Andy, perhaps you or Bob can address the second.

So I'll ask Alex to address the first question.

N D: And N D, perhaps you or Bob can address the second.

Alexander Arrow: Sure. William, good to hear from you. Your first question is the timeline for the readout of our SAD and MAD studies. The SAD or single ascending dose study is in progress now. We plan to have enrollment in that study complete by the end of April. As described in our last press release, we're planning to have a data readout on that within a couple of weeks of the completion of that, so it should be by mid-May. As for MAD, we intend to start enrolling essentially immediately as soon as SAD is complete and should have a data readout on that in early Q3. We had previously targeted July for that for the readout for MAD. Did I address all of your first question?

Alex Arrow: Sure. So William good to hear from you. So your first question is the timeline for the readout of our sad and Mad studies. So the sat or single ascending dose study is in progress now we plan to have enrollment in that study complete by the end of April.

Alex Arrow: As described in our last press release, where we're planning to have a data readout on that.

None: And within a couple of weeks with the completion of that so it shouldn't be by by mid May.

None: As for Mad, we intend to start enrolling.

None: Essentially immediately as soon as this.

None: It's a sad is complete.

None: And should have a data readout on that in early Q3, we had previously targeted July for that for the readout for for Matt.

None: So I think that was your third did I did I.

Address all of your first question.

William Wood: Yeah. Thank you.

None: Yeah, Yeah. Thank you yeah okay.

Alexander Arrow: Yep. Okay.

Garo Armen: Who would like to handle the second one on the additional steps we need on the regulatory front?

None: And who would like to handle the second one.

Additional steps, we need on the regulatory front.

None: Yeah.

None: Okay.

Alexander Arrow: You're saying the additional steps to start the phase II, William? Is that the nature of your question?

None: You're seeing the additional steps to start the phase II William is that the nature of your call I think the second question was what are the additional milestones on the regulatory program as we advance <unk> 00114, I think Bob perhaps something.

Garo Armen: I think the second question was, what are the additional milestones on the regulatory program as we advance PT00114? I think, Bob, perhaps you can.

None: Yeah.

Robert Stein: I can address that. We're in the process of finalizing our phase II protocol, and we'll have to submit that to the agency for approval. We're confident that we will have that because the compound is very safe and we've seen no safety signals so far. I think we'll have been able to address an appropriate dose for those studies from some of the biomarker work that we are planning to conduct. The format is very similar to studies that Dr. Fava has conducted with many other compounds in development for the treatment of anxiety and depression. He's really one of the world's leaders in the design of such studies.

Bob Stein: I can address that.

Bob Stein: We're in the process of finalizing our phase II protocol and both have to submit that to the agency for approval. We're confident that we will have that.

Bob Stein: Because this compound as various states and you see no safety signals. So far I think we will.

Bob Stein: I haven't been able to address an appropriate dose for those studies.

Bob Stein: From some of the biomarker work that we are.

Bob Stein: Planning to conduct.

Bob Stein: And the format.

Bob Stein: Very similar to our studies that Dr. Fava has conducted with many other.

Bob Stein: Compounds in development for the treatment of anxiety and depression is really good.

Bob Stein: One of the world's leaders in majors item such studies.

Andrew Slee: You may want to say this is called a basket trial and has great acceptance with regulatory agencies.

Bob Stein: You may want to say it is called a basket trial and has great acceptance with regulatory agencies.

Alexander Arrow: Yeah, that's a good point, Andy, because we do believe that the compound will have activity across a variety of neuropsychiatric disorders, and the plan is to enroll patients with examples of each of those and then track along the signals that we see for efficacy to enrich for those indications where we see the strongest signals, at least initially.

None: Yes, it's a good point, Andy because we do believe that the compound will have activity across a variety of neuropsychiatric disorders and the plan is to enroll patients.

None: Examples of each of those and then track along some of the signals that you see for efficacy to enrich for those indications, where we see the strongest signals at least initially.

William Wood: Got it. I appreciate that. Building on that, just one last question. You are evaluating the healthy individuals in your ongoing SAD and then going into your MAD. Should we be expecting any biomarker data from these initial trials, maybe highlighting the neuroprotective effects, understanding that they are primarily safety, but just curious what additional data, possibly biomarker, we may be able to expect.

Andy: Got it I appreciate that and then kind of building on that just one last question.

None: We're evaluating the healthy individuals in your in your ongoing sad and then going into your Mad.

None: Should we be expecting any biomarker data from these initial.

None: Initial trials, maybe highlighting the neuroprotective effects.

None: Understanding that there, they're primarily safety, but just curious what are what what additional data.

None: Biomarker, we may be able to expect.

Andrew Slee: We are collecting-

None: We are allocating biomarker data, but one of the things one really needs to understand is when you're dealing with healthy volunteers in the way, we actually treat healthy volunteers, we make sure that everything is calm and so that.

Robert Stein: Based on our animal-

Robert Stein: Biomarker data. One of the things one really needs to understand is when you're dealing with healthy volunteers and the way we actually treat healthy volunteers, we make sure that everything is calm and so that there's no sort of setting up a stress or anxiety condition amongst those. There are people who will come in and may be a little stressed, and we are making sure that we collect a sufficient amount of material so we can actually gauge a responsive biomarker.

None: There's no sort of setting up a stress or anxiety condition amongst those but there are people who will come in and maybe a little stressed and we are making sure that we can collect sufficient.

None: Sufficient amount of material. So we can actually engage a responsive biomarker.

Alexander Arrow: As a biomarker that we plan to announce, William, we do plan to announce cortisol levels when we announce both the SAD and the MAD results. In each case, we have measured cortisol levels and plan to include those in the disclosed results.

None: But as a biomarker that we plan to announce when we do plan to announce cortisol levels. When we announce the both the sad and Mad results in each case, we have we will have measured cortisol levels and plan to include those into disclose the results.

William Wood: Understood, and thank you. Thank you for taking our questions. I appreciate it, and congratulations again on a very nice quarter and year.

None: Understood and thank you all day every day on our questions I appreciate it and congratulations again on a very nice quarter and year.

Alexander Arrow: Thanks, William.

None: Excellent. Thank you.

Andrew Slee: Thank you.

Operator: If there are any remaining questions, please indicate so by pressing star one on your touchtone phone. Once again, please press star one if you have a question or a comment. Okay, looks like we have no further questions in queue. I'd like to turn the call back over to management for closing remarks.

If there are any remaining questions. Please indicate so by pressing star one on your Touchtone phone. Once again. Please press star one if you have a question or comment.

Okay. It looks like we have no further questions in queue I'd like to turn the call back over to management for closing remarks.

Garo Armen: Thank you very much, everybody, and thank you very much for your patience and participation through this journey. If you have additional questions, you can always feel free to call Alex and get to one of us. We welcome your engagement on a continuing basis. Thanks again.

Thank you very much everybody and thank you very much for your patience and participation through this journey.

None: If you have additional questions you can always feel free to call, Alex and get to one of us.

None: Welcome your engagement on a continuing basis. Thanks again.

Okay.

Operator: This concludes today's conference, and you may disconnect your lines at this time. Thank you for your participation.

None: This concludes today's conference and you may disconnect. Your lines at this time. Thank you for your participation.