Q4 2025 Inovio Pharmaceuticals Inc Earnings Call

March 12, 2026

Speaker #1: Good afternoon, ladies and gentlemen, and welcome to the INOVIO Fourth Quarter and Full Year 2025 Financial Results Conference Call. At this time, all lines are in a listen-only mode.

Operator: Good afternoon, ladies and gentlemen, and welcome to the Inovio Q4 and Full Year 2025 Financial Results Conference Call. At this time, all lines are in a listen-only mode. Following the presentation, we will conduct a question and answer session. If at any time during this call you require immediate assistance, please press star zero for the operator. This call is being recorded on Thursday, 12 March 2026. I would now like to turn the call over to Jennie Willson. Please go ahead.

Speaker #1: Following the presentation, we will conduct a question-and-answer session. If at any time during this call you require immediate assistance, please press *0 for the operator.

Speaker #1: This call is being recorded on Thursday, March 12, 2026. I would now like to turn the call over to Jennie Willson. Please go ahead.

Speaker #2: Good afternoon and thank you for joining the INOVIO Fourth Quarter and Full Year 2025 Financial Results Conference Call. Joining me on today's call are Dr. Jacqueline Shea, President and Chief Executive Officer; Dr. Mike Sumner, Chief Medical Officer; Steve Egge, Chief Commercial Officer; and Peter Kiese, Chief Financial Officer.

Jennie Willson: Good afternoon, and thank you for joining the Inovio Q4 and full year 2025 financial results conference call. Joining me on today's call are Dr. Jacqueline Shea, President and Chief Executive Officer, Dr. Michael Sumner, Chief Medical Officer, Steven Egge, Chief Commercial Officer, and Peter Kies, Chief Financial Officer. Today's call will review our corporate and financial information for the quarter and year ended December 31, 2025, as well as provide a general business update. Following prepared remarks, we will conduct a question and answer segment. During the call, we will be making forward-looking statements regarding future events and the future performance of the company.

Speaker #2: Today's call will review our corporate and financial information for the quarter and year ended December 31, 2025, as well as provide a general business update.

Speaker #2: Following prepared remarks, we will conduct a question-and-answer segment. During the call, we will be making forward-looking statements regarding future events and the future performance of the company.

Speaker #2: These events relate to our business plans to develop INOVIO's DNA Medicines platform, which includes clinical and regulatory developments and timing of clinical data readouts and planned regulatory submissions, our interactions with the FDA regarding our BLA for INO3107, including our yet-to-be-scheduled meeting with the FDA to discuss eligibility for the accelerated approval program.

Jennie Willson: These events relate to our business plans to develop Inovio's DNA medicines platform, which include clinical and regulatory developments and timing of clinical data readouts and planned regulatory submissions, our interactions with the FDA regarding our BLA for INO-3107, including our yet to be scheduled meeting with the FDA to discuss eligibility for the Accelerated Approval Program, the potential benefits of INO-3107 along with capital resources, including the sufficiency of our cash resources, our expectations regarding competition, the size and growth of the potential markets for INO-3107, if approved, and our ability to serve those markets, the rate and degree of market acceptance of INO-3107 and strategic matters. All of these statements are based on the beliefs and expectations of management as of today. Actual events or results could differ materially.

Speaker #2: The potential benefits of INO-3107, along with capital resources—including the sufficiency of our cash resources—our expectations regarding competition, the size and growth of the potential markets for INO-3107 if approved, and our ability to serve those markets.

Speaker #2: The rate and degree of market acceptance of INO3107, and strategic matters. All of these statements are based on the beliefs and expectations of management as of today.

Speaker #2: Actual events or results could differ materially. We refer you to the documents we file from time to time with the SEC, which, under the heading 'Risk Factors,' identify important factors that could cause actual results to differ materially from those expressed by the company verbally, as well as statements made within this afternoon's press release.

Jennie Willson: We refer you to the documents we file from time to time with the SEC, which, under the heading Risk Factors, identify important factors that could cause actual results to differ materially from those expressed by the company verbally, as well as statements made within this afternoon's press release. This call is being webcast live, and a link can be found on our website ir.inovio.com, and a replay will be made available shortly after this call is concluded. I will now turn the call over to Inovio's President and CEO, Dr. Jacqueline Shea.

Speaker #2: This call is being webcast live, and a link can be found on our website, ir.inovio.com. A replay will be made available shortly after this call is concluded.

Speaker #2: I will now turn the call over to INOVIO's President and CEO, Dr. Jacqueline Shea.

Speaker #3: Good afternoon, and thank you to everyone for joining today's call. These are very exciting times for INOVIO, with our first BLA for INO-3107 as a potential treatment for adults with recurrent respiratory papillomatosis, or RRP.

Jacqueline Shea: Good afternoon, and thank you to everyone for joining today's call. These are very exciting times for Inovio with our first BLA for INO-3107 as a potential treatment for adults with recurrent respiratory papillomatosis, or RRP, currently being reviewed by the FDA. In late December last year, we were pleased to announce that the FDA accepted our BLA for review under the Accelerated Approval Program. The FDA granted a standard 10-month review with a Prescription Drug User Fee Act, or PDUFA, target date set for October 30 of this year. While the BLA was accepted under the Accelerated Approval Program, in the BLA acceptance letter, the FDA noted as a potential review issue its preliminary conclusion that the company had not provided adequate information to justify eligibility for the Accelerated Approval Program.

Jackie Shea: Good afternoon, and thank you to everyone for joining today's call. These are very exciting times for Inovio with our first BLA for INO-3107 as a potential treatment for adults with recurrent respiratory papillomatosis, or RRP, currently being reviewed by the FDA. In late December last year, we were pleased to announce that the FDA accepted our BLA for review under the Accelerated Approval Program. The FDA granted a standard 10-month review with a Prescription Drug User Fee Act, or PDUFA, target date set for October 30 of this year. While the BLA was accepted under the Accelerated Approval Program, in the BLA acceptance letter, the FDA noted as a potential review issue its preliminary conclusion that the company had not provided adequate information to justify eligibility for the Accelerated Approval Program.

Speaker #3: Currently being reviewed by the FDA. In late December last year, we were pleased to announce that the FDA accepted our BLA for review under the accelerated approval program.

Speaker #3: The FDA granted a standard 10-month review with a Prescription Drug User Fee Act, or PDUFA, target date set for October 30 of this year.

Speaker #3: While the BLA was accepted under the accelerated approval program, in the file acceptance letter, the FDA noted as a potential review issue its preliminary conclusion that the company had not provided adequate information to justify eligibility for the accelerated approval program.

Speaker #3: This preliminary conclusion was made during the initial 60-day filing review period, and was the first time a potential issue with respect to eligibility had been raised.

Jacqueline Shea: This preliminary conclusion was made during the initial 60-day filing review period and was the first time a potential issue with respect to eligibility had been raised. As Mike will explain later in the presentation, we strongly believe that INO-3107 does fulfill the criteria for review under the Accelerated Approval Program by meeting an unmet medical need and providing a meaningful therapeutic benefit over existing treatment. The FDA has agreed to meet with us. We have provided additional documentation, and we're waiting for them to provide a meeting date. In the meantime, we are continuing to advance our commercial preparations, focusing on optimizing and extending our resources towards our October PDUFA date. To achieve this, Inovio has taken steps to further conserve its financial resources, rescoping projects and activities, and eliminating roles that don't directly support our primary goal of advancing INO-3107 towards US approval.

Jackie Shea: This preliminary conclusion was made during the initial 60-day filing review period and was the first time a potential issue with respect to eligibility had been raised. As Mike will explain later in the presentation, we strongly believe that INO-3107 does fulfill the criteria for review under the Accelerated Approval Program by meeting an unmet medical need and providing a meaningful therapeutic benefit over existing treatment. The FDA has agreed to meet with us. We have provided additional documentation, and we're waiting for them to provide a meeting date. In the meantime, we are continuing to advance our commercial preparations, focusing on optimizing and extending our resources towards our October PDUFA date. To achieve this, Inovio has taken steps to further conserve its financial resources, rescoping projects and activities, and eliminating roles that don't directly support our primary goal of advancing INO-3107 towards US approval.

Speaker #3: As Mike will explain later in the presentation, we strongly believe that INO-3107 does fulfill the criteria for review under the accelerated approval program, by meeting an unmet medical need and providing a meaningful therapeutic benefit over existing treatments.

Speaker #3: The FDA has agreed to meet with us. We have provided additional documentation, and we're waiting for them to provide a meeting date. In the meantime, we are continuing to advance our commercial preparations, focusing on optimizing and extending our resources towards our October PDUFA date.

Speaker #3: To achieve this, INOVIO has taken steps to further conserve its financial resources. Rescoping projects and activities and eliminating roles that don't directly support our primary goal of advancing INO3107 towards U.S.

Speaker #3: Approval. These efforts have enabled the extension of our estimated cash runway into the fourth quarter of this year. While the majority of our resources are directed to advancing our lead candidate towards approval, we are continuing to leverage the power of partnerships to advance other promising candidates in our pipeline.

Jacqueline Shea: These efforts have enabled the extension of our estimated cash runway into Q4 of this year. While the majority of our resources are directed to advancing our lead candidate towards approval, we are continuing to leverage the power of partnerships to advance other promising candidates in our pipeline. We have recently announced an exciting opportunity to build on our research in glioblastoma through an innovative Phase 2 adaptive platform trial sponsored by the Dana-Farber Cancer Institute, where we'll collaborate with Akeso to evaluate INO-5412 in combination with their novel PD-1/CTLA-4 bispecific antibody checkpoint inhibitor. Like our lead program, INO-3107, this program utilizes the antigen-specific cytotoxic T-cell generating ability of our DNA medicines platform. In this instance, to target cancer cells. We have also continued to advance some of our earlier stage next generation DNA medicine candidates, which I'll touch on later in this presentation.

Jackie Shea: These efforts have enabled the extension of our estimated cash runway into Q4 of this year. While the majority of our resources are directed to advancing our lead candidate towards approval, we are continuing to leverage the power of partnerships to advance other promising candidates in our pipeline. We have recently announced an exciting opportunity to build on our research in glioblastoma through an innovative Phase 2 adaptive platform trial sponsored by the Dana-Farber Cancer Institute, where we'll collaborate with Akeso to evaluate INO-5412 in combination with their novel PD-1/CTLA-4 bispecific antibody checkpoint inhibitor. Like our lead program, INO-3107, this program utilizes the antigen-specific cytotoxic T-cell generating ability of our DNA medicines platform. In this instance, to target cancer cells. We have also continued to advance some of our earlier stage next generation DNA medicine candidates, which I'll touch on later in this presentation.

Speaker #3: We have recently announced an exciting opportunity to build on our research in glioblastoma, through an innovative Phase II adaptive platform trial sponsored by the Dana-Farber Cancer Institute.

Speaker #3: Where we'll collaborate with a key zone, we'll evaluate INO5412 in combination with their novel PD1 CTLA4 bispecific antibody checkpoint inhibitor. Like our lead program, INO3107, this program utilizes the antigen-specific cytotoxic T-cell generating ability of our DNA Medicines platform.

Speaker #3: But in this instance, the target cancer cell. We have also continued to advance some of our earlier-stage, next-generation DNA medicine candidates, which I'll touch on later in this presentation.

Speaker #3: I look forward to advancing these programs in tandem with our top priority for 2026. Achieving FDA approval of our first product and bringing INO3107 to patients.

Jacqueline Shea: I look forward to advancing these programs in tandem with our top priority for 2026, achieving FDA approval of our first product and bringing INO-3107 to patients. Now, I'll turn it over to Mike for some additional insights on our regulatory progress with INO-3107. Mike.

Jackie Shea: I look forward to advancing these programs in tandem with our top priority for 2026, achieving FDA approval of our first product and bringing INO-3107 to patients. Now, I'll turn it over to Mike for some additional insights on our regulatory progress with INO-3107. Mike.

Speaker #3: Now I'll turn it over to Mike for some additional insights on our regulatory progress for 3107. Mike?

Speaker #2: Thanks, Jacqueline. As Jacqueline outlined, we have made significant progress with our BLA, as outlined on this slide, including the acceptance of our file for review under the accelerated approval program, with a PDUFA date of October 30, 2026.

Michael Sumner: Thanks, Jackie. As Jackie outlined, we have made significant progress with our BLA, as outlined on this slide, including the acceptance of our file for review under the Accelerated Approval Program with a PDUFA date of October 30, 2026. We believe our BLA makes a strong argument outlining how INO-3107 meets an unmet medical need and provides a meaningful therapeutic benefit over existing treatments, thus fulfilling the Accelerated Approval Program criteria. Our next step is to discuss this with the FDA. In preparation for this meeting, they had requested that we complete an assessment aid, which we submitted in February. In this document, we reiterate and expand on our rationale for accelerated approval review. It is important to note that while we wait to meet with the FDA, the BLA is under active review, and we have been responding to routine requests for information.

Mike Sumner: Thanks, Jackie. As Jackie outlined, we have made significant progress with our BLA, as outlined on this slide, including the acceptance of our file for review under the Accelerated Approval Program with a PDUFA date of October 30, 2026. We believe our BLA makes a strong argument outlining how INO-3107 meets an unmet medical need and provides a meaningful therapeutic benefit over existing treatments, thus fulfilling the Accelerated Approval Program criteria. Our next step is to discuss this with the FDA. In preparation for this meeting, they had requested that we complete an assessment aid, which we submitted in February. In this document, we reiterate and expand on our rationale for accelerated approval review. It is important to note that while we wait to meet with the FDA, the BLA is under active review, and we have been responding to routine requests for information.

Speaker #2: We believe our BLA makes a strong argument outlining how INO-3107 meets an unmet medical need and provides a meaningful therapeutic benefit over existing treatments.

Speaker #2: Thus fulfilling the accelerated approval program criteria. Our next step is to discuss this with the FDA. In preparation for this meeting, they had requested that we complete an assessment aid, which we submitted in February.

Speaker #2: In this document, we reiterate and expand on our rationale for accelerated approval review. It is important to note that, while we wait to meet with the FDA, the BLA is under active review.

Speaker #2: And we have been responding to routine requests for information. In addition, we submitted an updated protocol for our confirmatory trial to the IND, and are waiting for feedback from the agency regarding finalizing the study design.

Michael Sumner: In addition, we submitted an updated protocol for our confirmatory trial to the IND and are awaiting feedback from the agency regarding finalizing the study design. I'd like to take a moment to focus on why we believe INO-3107 meets the accelerated approval criteria. Following the unexpected full approval of PAPZIMOS in August last year, the regulatory landscape changed with respect to the requirements for eligibility. Based on published FDA guidance, when there's an already approved product, eligibility for accelerated approval depends on a candidate's ability to provide a meaningful therapeutic benefit over existing treatments and its ability to meet a remaining critical unmet need among patients.

Mike Sumner: In addition, we submitted an updated protocol for our confirmatory trial to the IND and are awaiting feedback from the agency regarding finalizing the study design. I'd like to take a moment to focus on why we believe INO-3107 meets the accelerated approval criteria. Following the unexpected full approval of PAPZIMOS in August last year, the regulatory landscape changed with respect to the requirements for eligibility. Based on published FDA guidance, when there's an already approved product, eligibility for accelerated approval depends on a candidate's ability to provide a meaningful therapeutic benefit over existing treatments and its ability to meet a remaining critical unmet need among patients.

Speaker #2: I'd like to take a moment to focus on why we believe 3107 meets the accelerated approval criteria. Following the unexpected full approval of Pap smears in August last year, the regulatory landscape changed with respect to the requirements for eligibility.

Speaker #2: Based on published FDA guidance, when there's an already approved product, eligibility for accelerated approval depends on a candidate's ability to provide a meaningful therapeutic benefit over existing treatments and its ability to meet a remaining critical unmet need among patients.

Speaker #2: We believe that 3107 meets both of those criteria, based on demonstrated efficacy and an improved safety profile that does not include required surgery during the dosing window, and a differentiated mechanism of action that provides the ability to treat patients who are not able to be served by existing therapy.

Michael Sumner: We believe that INO-3107 meets both of those criteria based on demonstrated efficacy, an improved safety profile that does not include required surgery during the dosing window, and a differentiated mechanism of action that provides the ability to treat patients who are not able to be served by existing therapy. Getting into more detail, in our trial, the majority of patients experienced fewer surgeries after treatment with INO-3107, with most experiencing a 50 to 100% reduction compared to the year before treatment. That clinical benefit continued to improve in the second 12-month period post-treatment, with half of the patients requiring 0 surgeries during that time. Efficacy was achieved without the vast majority of patients requiring surgery during the dosing window, a key differentiating advantage of the INO-3107 safety profile.

Mike Sumner: We believe that INO-3107 meets both of those criteria based on demonstrated efficacy, an improved safety profile that does not include required surgery during the dosing window, and a differentiated mechanism of action that provides the ability to treat patients who are not able to be served by existing therapy. Getting into more detail, in our trial, the majority of patients experienced fewer surgeries after treatment with INO-3107, with most experiencing a 50 to 100% reduction compared to the year before treatment. That clinical benefit continued to improve in the second 12-month period post-treatment, with half of the patients requiring 0 surgeries during that time. Efficacy was achieved without the vast majority of patients requiring surgery during the dosing window, a key differentiating advantage of the INO-3107 safety profile.

Speaker #2: Getting into more detail, in our trial, the majority of patients experienced fewer surgeries after treatment with 3107. With most experiencing a 50% to 100% reduction compared to the year before treatment.

Speaker #2: That clinical benefit continued to improve in the second 12-month period post-treatment, with half of the patients requiring zero surgeries during that time. Efficacy was achieved without the vast majority of patients requiring surgery during the dosing window.

Speaker #2: A key differentiating advantage of the 3107 safety profile: remember, in our Phase I/II trial, our protocol counted every surgery conducted after day zero. In contrast, surgeries conducted during the 12-week treatment window in the Pap smears trial were not counted against the efficacy endpoint, and 72% of the reported complete responders in the single-site Phase I/II trial had at least one surgery during the 12-week dosing window.

Michael Sumner: Remember, in our phase 1/2 trial, our protocol counted every surgery conducted after day 0. In contrast, surgeries conducted during the 12-week treatment window in the Papzimeos trial were not counted against the efficacy endpoint, and 72% of the reported complete responders in the single-site phase 1/2 trial had at least one surgery during the 12-week dosing window to maintain what is referred to as minimal residual disease or MRD, a protocol that is required for the efficacy of that product and is included in the label. Additionally, INO-3107 offers a differentiated mechanism of action, which provides the ability to treat patients who are not served by existing therapy, and thus address an unmet need in the RRP treatment landscape.

Mike Sumner: Remember, in our phase 1/2 trial, our protocol counted every surgery conducted after day 0. In contrast, surgeries conducted during the 12-week treatment window in the Papzimeos trial were not counted against the efficacy endpoint, and 72% of the reported complete responders in the single-site phase 1/2 trial had at least one surgery during the 12-week dosing window to maintain what is referred to as minimal residual disease or MRD, a protocol that is required for the efficacy of that product and is included in the label. Additionally, INO-3107 offers a differentiated mechanism of action, which provides the ability to treat patients who are not served by existing therapy, and thus address an unmet need in the RRP treatment landscape.

Speaker #2: To maintain what is referred to as minimal residual disease, or MRD. A protocol that is required for the efficacy of that product and is included in the label.

Speaker #2: Additionally, 3107 offers a differentiated mechanism of action which provides the ability to treat patients who are not served by existing therapy and thus address an unmet need in the RRP treatment landscape.

Speaker #2: Pap smears utilizes a Gorilla adenoviral vector, and it is well established in the scientific literature that efficacy of adenoviral vectors may be impacted by pre-existing neutralizing antibodies, as they have been shown to limit the immune response that patients with these antibodies can generate.

Michael Sumner: Papzimeos utilizes a gorilla adenoviral vector, and it is well established in the scientific literature that efficacy of adenoviral vectors may be impacted by preexisting neutralizing antibodies, as they have been shown to limit the immune response that patients with these antibodies can generate. In addition, several immune factors relating to the papilloma microenvironment were identified by the investigators as being linked to the lack of efficacy for Papzimeos. In contrast, our data published in Nature Communications shows that efficacy of INO-3107 is not impacted by the papilloma microenvironment. We look forward to discussing our rationale for review under accelerated approval with the FDA, and with that, I will now turn over to Steve for a brief commercial update. Steve.

Mike Sumner: Papzimeos utilizes a gorilla adenoviral vector, and it is well established in the scientific literature that efficacy of adenoviral vectors may be impacted by preexisting neutralizing antibodies, as they have been shown to limit the immune response that patients with these antibodies can generate. In addition, several immune factors relating to the papilloma microenvironment were identified by the investigators as being linked to the lack of efficacy for Papzimeos. In contrast, our data published in Nature Communications shows that efficacy of INO-3107 is not impacted by the papilloma microenvironment. We look forward to discussing our rationale for review under accelerated approval with the FDA, and with that, I will now turn over to Steve for a brief commercial update. Steve.

Speaker #2: In addition, several immune factors relating to the papilloma microenvironment were identified by the investigators, as being linked to the lack of efficacy for Pap smears.

Speaker #2: In contrast, our data published in Nature Communications shows that the efficacy of INO-3107 is not impacted by the papilloma microenvironment. We look forward to discussing our rationale for review under accelerated approval with the FDA. And with that, I will now turn it over to Steve for a brief commercial update.

Speaker #2: Steve?

Speaker #3: Thanks, Mike. The burden of RRP on patients is significant, and there's an urgent need for treatment options that reduce the need for repeated surgery.

Steven Egge: Thanks, Mike. The burden of RRP on patients is significant, and there's an urgent need for treatment options that reduce the need for repeated surgery. RRP is characterized by chronic wart-like growths called papilloma that grow in the respiratory tract and can cause difficulty speaking, swallowing, and breathing. Surgery is still the standard of care, and patients have numerous surgeries, sometimes hundreds of surgeries in the most severe cases, throughout their lifetime. Every surgery matters to patients because the risk is well-established. Every surgery carries the risk of permanent damage to the vocal cords and airways. The cost of surgery can have a significant impact as well. Traveling hundreds of miles for specialized RRP care, missing work and social functions while preparing for or recovering from surgery. The anxiety and frustration of impaired voice quality, making it difficult to communicate, and the psychological trauma of undergoing repeated surgeries.

Steve Egge: Thanks, Mike. The burden of RRP on patients is significant, and there's an urgent need for treatment options that reduce the need for repeated surgery. RRP is characterized by chronic wart-like growths called papilloma that grow in the respiratory tract and can cause difficulty speaking, swallowing, and breathing. Surgery is still the standard of care, and patients have numerous surgeries, sometimes hundreds of surgeries in the most severe cases, throughout their lifetime. Every surgery matters to patients because the risk is well-established. Every surgery carries the risk of permanent damage to the vocal cords and airways. The cost of surgery can have a significant impact as well. Traveling hundreds of miles for specialized RRP care, missing work and social functions while preparing for or recovering from surgery. The anxiety and frustration of impaired voice quality, making it difficult to communicate, and the psychological trauma of undergoing repeated surgeries.

Speaker #3: RRP is characterized by chronic work-like growth called papilloma to grow in the respiratory tract and can cause difficulty speaking, swallowing, and breathing. Surgery is still the standard of care, and patients have numerous surgeries, sometimes hundreds of surgeries in the most severe cases, throughout their lifetime.

Speaker #3: Every surgery matters to patients because the risk is well established. Every surgery carries the risk of permanent damage to the vocal cords and airways.

Speaker #3: And the cost of surgery can have a significant impact as well. Traveling hundreds of miles for specialized RRP care missing work and social functions while preparing for or recovering from surgery the anxiety and frustration of impaired voice quality making it difficult to communicate, and the psychological trauma of undergoing repeated surgeries.

Speaker #3: This is why we're committed to delivering on the potential of 3107 for RRP patients. And that potential has been validated in market research, which supports our belief that this product is poised to become the preferred treatment based on its efficacy, tolerability, and simple treatment regimen.

Steven Egge: This is why we're committed to delivering on the potential of INO-3107 for RRP patients, and that potential has been validated in market research, which supports our belief that this product is approved to become the preferred treatment based on its efficacy, tolerability, and simple treatment regimen. I shared these insights previously, but I think they bear repeating. Physicians we engaged in market research were most interested in the fact that the vast majority of patients saw a 50 to 100% reduction in surgery from INO-3107, and for many of them, that clinical benefit continued to improve over time. Physicians were similarly impressed with the tolerability data, which shows that INO-3107 was generally well-tolerated, limiting the impact on patients' return to daily life. This is important considering the treatment protocol includes 4 doses over a relatively short period of time.

Steve Egge: This is why we're committed to delivering on the potential of INO-3107 for RRP patients, and that potential has been validated in market research, which supports our belief that this product is approved to become the preferred treatment based on its efficacy, tolerability, and simple treatment regimen. I shared these insights previously, but I think they bear repeating. Physicians we engaged in market research were most interested in the fact that the vast majority of patients saw a 50 to 100% reduction in surgery from INO-3107, and for many of them, that clinical benefit continued to improve over time. Physicians were similarly impressed with the tolerability data, which shows that INO-3107 was generally well-tolerated, limiting the impact on patients' return to daily life. This is important considering the treatment protocol includes 4 doses over a relatively short period of time.

Speaker #3: I've shared these insights previously, but I think they bear repeating. Physicians we engaged in market research were most interested in the fact that the vast majority of patients die—50% to 100% reduction in surgery from 3107—and for many of them, that clinical benefit continued to improve over time.

Speaker #3: Physicians were similarly impressed with the tolerability data, which shows that 3107 was generally well tolerated, limiting the impact on patients' return to daily life.

Speaker #3: This is important, considering the treatment protocol includes four doses over a relatively short period of time. And in terms of the treatment regimen itself, 3107 takes into account concerns of both physicians and RRP patients.

Steven Egge: In terms of the treatment regimen itself, INO-3107 takes into account concern of both physicians and RRP patients. It can be administered in the physician's office without an ultra-cold chain requirement. The device is simple to use, and importantly, there's no requirement for surgeries to maintain minimum residual disease during the treatment window. This is a key area of differentiation from Precigen's gorilla adenoviral-based therapy, which, as Mike noted, requires scoping and surgery during the treatment window to maintain minimum residual disease. Precigen's data publication indicates that these surgeries are required to mitigate the effect of the immunosuppressive papilloma microenvironment to maximize the chance of clinical benefit from the product. We believe this key difference makes INO-3107 a more patient-centric approach to treating RRP.

Steve Egge: In terms of the treatment regimen itself, INO-3107 takes into account concern of both physicians and RRP patients. It can be administered in the physician's office without an ultra-cold chain requirement. The device is simple to use, and importantly, there's no requirement for surgeries to maintain minimum residual disease during the treatment window. This is a key area of differentiation from Precigen's gorilla adenoviral-based therapy, which, as Mike noted, requires scoping and surgery during the treatment window to maintain minimum residual disease. Precigen's data publication indicates that these surgeries are required to mitigate the effect of the immunosuppressive papilloma microenvironment to maximize the chance of clinical benefit from the product. We believe this key difference makes INO-3107 a more patient-centric approach to treating RRP.

Speaker #3: It can be administered in the physician's office, without an ultra-cold chain requirement. The device is simple to use, and importantly, there's no requirement for surgeries to maintain minimum residual disease during the treatment window.

Speaker #3: This is a key area of differentiation from precedents. Gorilla adenoviral-based therapy, which as Mike noted, requires scoping and surgery during the treatment window to maintain minimum residual disease.

Speaker #3: Precedent data publication indicates that these surgeries are required to mitigate the effect of the immunosuppressive papilloma microenvironment to maximize the chance of clinical benefit from the product.

Speaker #3: We believe this key difference makes 3107 a more patient-centric approach to treating RRP. I will also mention that the recently published RRP Foundation Physician Statement on the management of adults with RRP now recommends immunotherapy as first-line treatment for RRP and notes that 3107, if approved, would also be included as a first-line treatment option.

Steven Egge: I will also mention that the recently published RRP Foundation position statement on the management of adults with RRP now recommends immunotherapy as first-line treatment for RRP and notes that INO-3107, if approved, would also be included as a first-line treatment option. I would also like to share just a few updates on our ongoing commercial launch preparations. Over the past year, we've executed critical market research, which informs strategic choices on launch preparations for INO-3107. We completed targeting segmentation and product positioning work and developed our pricing strategy. On the operational front, we've selected key commercial partners, including our third-party logistics provider, specialty distributor, specialty pharmacy, patient services hub, and our agency of record. We are also finalizing our go-to-market model and planning the build-out of our commercial organization. I look forward to providing further updates on our progress next quarter.

Steve Egge: I will also mention that the recently published RRP Foundation position statement on the management of adults with RRP now recommends immunotherapy as first-line treatment for RRP and notes that INO-3107, if approved, would also be included as a first-line treatment option. I would also like to share just a few updates on our ongoing commercial launch preparations. Over the past year, we've executed critical market research, which informs strategic choices on launch preparations for INO-3107. We completed targeting segmentation and product positioning work and developed our pricing strategy. On the operational front, we've selected key commercial partners, including our third-party logistics provider, specialty distributor, specialty pharmacy, patient services hub, and our agency of record. We are also finalizing our go-to-market model and planning the build-out of our commercial organization. I look forward to providing further updates on our progress next quarter.

Speaker #3: I would also like to share just a few updates on our ongoing commercial launch preparations. Over the past year, we've executed critical market research, which informs strategic choices on launch preparations for 3107.

Speaker #3: We completed targeting segmentation of product positioning work and developed our pricing strategy. On the operational front, we've selected key commercial partners, including our third-party logistics provider, specialty distributor, specialty pharmacy, patient services hub, and our agency of record.

Speaker #3: We were also finalizing our go-to-market model and planning to build out of our commercial organization. I look forward to providing further updates on our progress next quarter.

Speaker #3: I'll now turn it back over to Jackie for a pipeline update.

Steven Egge: I'll now turn it back over to Jackie for a pipeline update.

Steve Egge: I'll now turn it back over to Jackie for a pipeline update.

Speaker #2: Thanks, Steve. While we remain steadfastly focused on INO-3107, in the past few quarters we've also provided some important updates on how we're continuing to advance our DNA medicine platform.

Jacqueline Shea: Thanks, Steve. While we remain steadfastly focused on INO-3107, in the past few quarters, we've also provided some important updates on how we're continuing to advance our DNA medicine platform. That includes promising phase I proof of concept dMAb data published in Nature Medicine in October of last year, which demonstrated the technology's ability to durably and tolerably produce monoclonal antibodies, a complex protein, within the human body for up to 72 weeks without generating anti-drug antibodies. Additional data presented this year has now demonstrated consistent production of dMAbs out to 96 weeks. Our dPROT technology builds on this research, aiming to enable additional types of complex proteins to be made within the body.

Jackie Shea: Thanks, Steve. While we remain steadfastly focused on INO-3107, in the past few quarters, we've also provided some important updates on how we're continuing to advance our DNA medicine platform. That includes promising phase I proof of concept dMAb data published in Nature Medicine in October of last year, which demonstrated the technology's ability to durably and tolerably produce monoclonal antibodies, a complex protein, within the human body for up to 72 weeks without generating anti-drug antibodies. Additional data presented this year has now demonstrated consistent production of dMAbs out to 96 weeks. Our dPROT technology builds on this research, aiming to enable additional types of complex proteins to be made within the body.

Speaker #2: That includes promising Phase 1, proof-of-concept DMAP data published in Nature Medicine in October of last year, which demonstrated the technology's ability to durably and tolerably produce monoclonal antibodies.

Speaker #2: A complex protein within the human body for up to 72 weeks, without generating anti-drug antibodies. Additional data presented this year has now demonstrated consistent production of DMAPs out to 96 weeks.

Speaker #2: Our DPROC technology built on this research. Aiming to enable additional types of complex proteins to be made within the body. Pre-clinical work evaluating the potential to expand into in vivo production of other types of therapeutic proteins.

Jacqueline Shea: Pre-clinical work evaluating the potential to expand into in vivo production of other types of therapeutic proteins was presented at the World Federation of Hemophilia Global Forum last November, including our first data on factor VIII production. We see great potential for this DPROC technology to treat multiple diseases and are actively seeking partnerships to advance additional rare disease targets into clinical evaluation. We also announced an exciting opportunity to build on our research in glioblastoma, or GBM, the most common and deadly brain cancer, through an innovative phase 2 adaptive platform trial sponsored by the Dana-Farber Cancer Institute. In this trial, we will partner with Akeso to evaluate INO-5412 in combination with cadonilimab, their first-in-class PD-1/CTLA-4 bispecific antibody checkpoint inhibitor. The trial is planned to initiate in the second half of this year.

Jackie Shea: Pre-clinical work evaluating the potential to expand into in vivo production of other types of therapeutic proteins was presented at the World Federation of Hemophilia Global Forum last November, including our first data on factor VIII production. We see great potential for this DPROC technology to treat multiple diseases and are actively seeking partnerships to advance additional rare disease targets into clinical evaluation. We also announced an exciting opportunity to build on our research in glioblastoma, or GBM, the most common and deadly brain cancer, through an innovative phase 2 adaptive platform trial sponsored by the Dana-Farber Cancer Institute. In this trial, we will partner with Akeso to evaluate INO-5412 in combination with cadonilimab, their first-in-class PD-1/CTLA-4 bispecific antibody checkpoint inhibitor. The trial is planned to initiate in the second half of this year.

Speaker #2: Was presented at the World Federation of Hemophilia Global Forum last November. Including our first data on factor VIII production. We see great potential for this DPROC technology to treat multiple diseases and are actively seeking partnerships to advance additional rare disease targets into clinical evaluation.

Speaker #2: We also announced an exciting opportunity to build on our research in glioblastoma or GBM. The most common and deadly brain cancer. Show an innovative phase two adaptive platform trial sponsored by the Dana-Farber Cancer Institute.

Speaker #2: In this trial, we will partner with Akizo to evaluate INO-5412 in combination with Ketanillamab, their first-in-class PD-1/CTLA-4 bispecific antibody checkpoint inhibitor. The trial is planned to initiate in the second half of this year.

Speaker #2: INO5412 is composed of INO5401. Which encodes the three tumor-associated antigens. And INO9012, which encodes the IL-12 and immune stimulants. When combined with a checkpoint blockade, this targeted DNA immunotherapy has the potential to overcome the limitations for immune checkpoint therapy alone.

Jacqueline Shea: INO-5412 is composed of INO-5401, which encodes for three tumor-associated antigens, and INO-9012, which encodes for IL-12, an immune stimulant. When combined with a checkpoint blockade, this targeted DNA immunotherapy has the potential to overcome the limitations for immune checkpoint therapy alone by stimulating a T-cell based immune response against the tumor antigen and driving T-cell infiltration into the GBM tumor microenvironment. Combining 5412 with Akeso's novel checkpoint modality represents an important evolution of our research in GBM. Building on our previous data showing the potential to improve patient outcomes, and highlights our ongoing commitment to advancing innovative treatments for rare diseases with significant unmet need. We are looking forward to collaborating with these two trailblazing partners and leveraging a unique opportunity to efficiently advance another promising late-stage candidate. Now I'll turn it over to our CFO, Peter Kies, for a financial update. Peter?

Jackie Shea: INO-5412 is composed of INO-5401, which encodes for three tumor-associated antigens, and INO-9012, which encodes for IL-12, an immune stimulant. When combined with a checkpoint blockade, this targeted DNA immunotherapy has the potential to overcome the limitations for immune checkpoint therapy alone by stimulating a T-cell based immune response against the tumor antigen and driving T-cell infiltration into the GBM tumor microenvironment. Combining 5412 with Akeso's novel checkpoint modality represents an important evolution of our research in GBM. Building on our previous data showing the potential to improve patient outcomes, and highlights our ongoing commitment to advancing innovative treatments for rare diseases with significant unmet need. We are looking forward to collaborating with these two trailblazing partners and leveraging a unique opportunity to efficiently advance another promising late-stage candidate. Now I'll turn it over to our CFO, Peter Kies, for a financial update. Peter?

Speaker #2: By stimulating a T-cell-based immune response against the tumor antigen. And driving T-cell infiltration into the GBM tumor microenvironment. Combining 5412 with Akizo's novel checkpoint modality represents an important evolution of our research in GBM.

Speaker #2: Building on our previous data showing the potential to improve patient outcomes. And highlights our ongoing commitment to advancing innovative treatments for rare diseases with significant unmet need.

Speaker #2: We are looking forward to collaborating with these two trailblazing partners and leveraging a unique opportunity to efficiently advance another promising late-stage candidate. Now I'll turn it over to our CFO, Peter Keyes, for a financial update.

Speaker #2: Peter.

Speaker #3: Thanks, Jackie. Today I'd like to provide an overview of INOVIO's financial results for the fourth quarter and full year of 2025. As Jackie noted, our primary goal is to advance INO-3107 towards approval.

Peter Kies: Thanks, Jackie. Today, I'd like to provide an overview of Inovio's financial results for the Q4 and full year of 2025. As Jackie noted, our primary goal is to advance INO-3107 towards approval, and we remain focused on directing resources and extending our cash runway towards a potential launch date in 2026. With the October PDUFA date in mind, we have further prioritized programs and resources, including recently reducing headcount by approximately 15% and have focused on continuing to reduce spending to extend our cash runway. We now estimate our cash runway to take us into Q4 2026. This projection includes an operational net cash burn estimate of approximately $22 million for the Q1 of 2026. Historically, our first quarter operational net cash burn runs higher than other quarters. These cash runway projections do not include any further capital raising activities that we may undertake.

Speaker #3: And we remain focused on directing resources and extending our cash runway toward a potential launch date in 2026. With the October PDUFA date in mind, we have further prioritized programs and resources, including recently reducing headcount by approximately 15%.

Speaker #3: And have focused on continuing to reduce spending to extend our cash runway. We now estimate our cash runway to take us into the fourth quarter of 2026.

Speaker #3: This projection includes an operational net cash burn estimate of approximately $22 million for the first quarter of 2026. Historically, our first-quarter operational net cash burn runs higher than other quarters.

Speaker #3: These cash runway projections do not include any further capital raising activities that we may undertake. We finished the fourth quarter of 2025 with $58.5 million in cash, cash equivalents, and short-term investments.

Peter Kies: We finished Q4 2025 with $58.5 million in cash equivalents, and short-term investments, compared to $94.1 million as of December 31, 2024. Turning to our results for 2025. Our total operating expenses dropped from $20.5 million in Q4 2024 to $17.5 million in Q4 2025. Our full-year operational expenses decreased 23% from $112.6 million in 2024 to $86.9 million in 2025. Inovio reported a net income for Q4 2025 of $3.8 million or $0.06 per share, and a dilutive net loss per share of $0.26. Our total net loss for the full year of 2025 was $84.9 million or $1.81 per share, basic and dilutive.

Speaker #3: Compared to $94.1 million as of December 31, 2024. Turning to our results for 2025, our total operating expenses dropped from $20.5 million in the fourth quarter of 2024 to $17.5 million in the fourth quarter of 2025.

Speaker #3: Our full-year operating expenses decreased 23%, from $112.6 million in 2024 to $86.9 million in 2025. INOVIO reported net income for the fourth quarter of 2025 of $3.8 million, or 6 cents per share, and a diluted net loss per share of 26 cents.

Speaker #3: Our total net loss for the full year of 2025 was $84.9 million or $1.81 per share basic and dilute. The net income for the fourth quarter 2025 was primarily driven by a $21.2 million non-cash gain on fair value adjustment related to our warrant liability.

Peter Kies: The net income for Q4 2025 was primarily driven by a $21.2 million non-cash gain on fair value adjustment related to our warrant liability. As the fair value of the warrants fluctuates with our share price and other market inputs, the adjustment can result in significant variability in our reported net income or loss. As a reminder, you can find our full financial statements in this afternoon's press release, as well as in our annual report Form 10-K filed with the SEC today. With that, I'll turn it back over to Jackie.

Speaker #3: As the fair value of the warrants fluctuates with our share price and other market inputs, the adjustment can result in significant variability in our reported net income or loss.

Speaker #3: As a reminder, you can find our full financial statements in this afternoon's press release as well as in our annual report form 10-K filed with the SEC today.

Speaker #3: And with that, I'll turn it back over to Jackie.

Speaker #2: Thanks, Peter. I'd now like to pause and open up the call to answer any questions you might have. Operator?

Jacqueline Shea: Thanks, Peter. I'd now like to pause and open up the call to answer any questions you might have. Operator?

Jackie Shea: Thanks, Peter. I'd now like to pause and open up the call to answer any questions you might have. Operator?

Speaker #4: And thank you. Ladies and gentlemen, we will now begin our question and answer session. Should you have a question, please press the star followed by the one on your touchtone phone.

Operator: Thank you. Ladies and gentlemen, we will now begin our question and answer session. Should you have a question, please press the star followed by the one on your touch tone phone. You will hear a prompt that your hand has been raised. Should you wish to decline from the polling process, please press the star followed by the two. If you're using a speakerphone, please lift up the handset first before pressing any keys. We have our first question from Ted Tenthoff with Piper Sandler. Please go ahead.

Speaker #4: You will hear a prompt that your hand has been raised. Should you wish to decline from the polling process, please press the star followed by the two, and if you're using a speakerphone, please lift up the handset first before pressing any keys.

Speaker #4: And we have our first question from Ted Tentoff with Piper Sandler. Please go ahead.

Speaker #5: Great. Thank you very much. I wanted to first start just with respect to the conversations with the FDA upcoming regarding accelerated approval. Are there any additional data that you would need to submit or what other factors would go into that conversation for potentially transitioning the review to accelerated approval?

Ted Tenthoff: Great. Thank you very much. I wanted to first start just with respect to the conversations with the FDA upcoming regarding accelerated approval. Are there any additional data that you would need to submit, or what other factors will go into that conversation for potentially transitioning the review to accelerated approval? Thank you.

Speaker #5: Thank you.

Speaker #2: Thanks, Ted. Great question. So, there's no new clinical data; however, we have already submitted new documentation to the FDA in the form of an assessment aid, which we submitted in February.

Jacqueline Shea: Thanks, Ted. Great question. There's no new clinical data. However, we have already submitted new documentation to the FDA in the form of an assessment aid, which we submitted in February. We're now waiting for the FDA to get back to us regarding the date of the meeting. Mike, anything you want to add to that?

Jackie Shea: Thanks, Ted. Great question. There's no new clinical data. However, we have already submitted new documentation to the FDA in the form of an assessment aid, which we submitted in February. We're now waiting for the FDA to get back to us regarding the date of the meeting. Mike, anything you want to add to that?

Speaker #2: So, we're now waiting for the FDA to get back to us regarding the date of the meeting. Mike, anything you want to add to that?

Speaker #5: Yeah, I mean, the only thing I'd add, Ted, is we utilize that document to sort of reiterate what we put in our original BLA submission and really expand on our rationale for accelerated approval review.

Michael Sumner: Yeah, the only thing I'd add, Ted, is we utilize that document to sort of reiterate what we put in our original BLA submission and really expand on our rationale for accelerated approval review. We're, as I mentioned, looking forward to having those discussions with the agency.

Mike Sumner: Yeah, the only thing I'd add, Ted, is we utilize that document to sort of reiterate what we put in our original BLA submission and really expand on our rationale for accelerated approval review. We're, as I mentioned, looking forward to having those discussions with the agency.

Speaker #5: So we're, as I mentioned, we're looking forward to having those discussions with the agency.

Speaker #6: Great. Thank you very much.

Ted Tenthoff: Great. Thank you very much.

Speaker #4: And thank you. We have our next question from Jay Olson with Oppenheimer.

Operator: Thank you. We have our next question from Jay Olson with Oppenheimer.

Speaker #7: Oh, hey, thanks for providing this update and taking our questions. We had a couple of questions. I guess maybe to start with, if you do eventually gain alignment with the FDA on a priority review, how would a six-month priority review timeline impact your ability to launch and any launch preparations that you have underway?

Jay Olson: Oh, hey, thanks for providing this update and taking our questions. We had a couple questions. I guess maybe to start with, if you do eventually gain alignment with the FDA on a priority review, how would a six-month priority review timeline impact your ability to launch and any launch preparations you have underway? If you could just talk about that'd be great. We have one follow-up, please.

Speaker #7: If you could just talk about that, that would be great. And then we have one follow-up, please.

Speaker #2: Thanks, Jay. Nice to hear from you. So, our focus at the moment is really on ensuring we have alignment with the FDA for review under the accelerated program.

Jacqueline Shea: Thanks, Jay. Nice to hear from you. Our focus at the moment is really on ensuring we have alignment with FDA for review under the accelerated program. We're not really focused on priority review at this stage. However, having said that, we are well advanced in our commercial preparation, and I'll ask Steve to make any comments here.

Jackie Shea: Thanks, Jay. Nice to hear from you. Our focus at the moment is really on ensuring we have alignment with FDA for review under the accelerated program. We're not really focused on priority review at this stage. However, having said that, we are well advanced in our commercial preparation, and I'll ask Steve to make any comments here.

Speaker #2: We're not really focused on priority review at this stage. However, having said that, we are well advanced in our commercial preparations. And I'll ask Steve to make any comments here.

Speaker #8: Yeah, so as I mentioned in the prepared remarks, I mean, we've done a lot of market research with physicians, with patients, with payers. So we feel like we know the market opportunity quite well.

Steven Egge: Yeah. As I mentioned in the prepared remarks, I mean, we've done a lot of market research with physicians, with patients, you know, with payers. We feel like we know the market opportunity quite well. We've built our strategies around that. We've got our commercial partners kind of on board or selected and we will be prepared to get out of the gate really quickly, you know, should we get approved. I think we're doing everything that we need to to be prepared and to move very quickly, you know, once the FDA makes a decision.

Steve Egge: Yeah. As I mentioned in the prepared remarks, I mean, we've done a lot of market research with physicians, with patients, you know, with payers. We feel like we know the market opportunity quite well. We've built our strategies around that. We've got our commercial partners kind of on board or selected and we will be prepared to get out of the gate really quickly, you know, should we get approved. I think we're doing everything that we need to to be prepared and to move very quickly, you know, once the FDA makes a decision.

Speaker #8: We've built kind of our strategies around that. We've got our commercial partners kind of on board or selected. And we would be prepared to get out of the gate really, really quickly.

Speaker #8: Should we get approved? So, I think we're doing everything that we need to do to be prepared and to move very quickly once the FDA makes a decision.

Speaker #7: Okay. Great. Thank you for that. And then if we could follow up on the publication in Nature Communications and the Loringoscope, can you just talk about any feedback that you got from KOLs and patients and how you might anticipate that feedback to translate into the uptake trajectory on upon approval?

Jay Olson: Okay, great. Thank you for that. If we could follow up on the publication in Nature Communications and the Laryngoscope. Can you just talk about any feedback that you got from KOLs and patients and how you might anticipate that feedback to translate into the uptake trajectory upon approval?

Speaker #2: Yeah, great question, Jay. So, as we mentioned on the call, we do believe that we have the preferred product profile in the space, and that's based across efficacy, tolerability, and a very patient-centric treatment regimen.

Jacqueline Shea: Yeah. Great question, Jay. As we mentioned on the call, we do believe that we have the preferred product profile in this space, and that's based across efficacy, tolerability, and a very patient-centric treatment regimen. When we've conducted research, and this was research conducted by a third-party provider, both patients and physicians really appreciated and preferred the product profile for INO-3107. What was really interesting to them was the fact that the majority of patients see a significant reduction in the numbers of surgeries. 72% of patients see a 50 to 100% reduction in the first year following treatments, and that improves up to 86% in the second year, with 50% of patients in the second year requiring no surgeries at all. A very strong efficacy profile.

Jackie Shea: Yeah. Great question, Jay. As we mentioned on the call, we do believe that we have the preferred product profile in this space, and that's based across efficacy, tolerability, and a very patient-centric treatment regimen. When we've conducted research, and this was research conducted by a third-party provider, both patients and physicians really appreciated and preferred the product profile for INO-3107. What was really interesting to them was the fact that the majority of patients see a significant reduction in the numbers of surgeries. 72% of patients see a 50 to 100% reduction in the first year following treatments, and that improves up to 86% in the second year, with 50% of patients in the second year requiring no surgeries at all. A very strong efficacy profile.

Speaker #2: And when we've conducted research—and this research was conducted by a third-party provider—both patients and physicians really appreciated and preferred the product profile for 3107.

Speaker #2: And what was really interesting to them was the fact that the majority of patients see a significant reduction in the numbers of surgeries. So 72% of patients see a 50% to to 100% reduction in the first year following treatments.

Speaker #2: And that improves up to 86% in the second year, with 50% of patients in the second year requiring no surgeries at all. So, a very strong efficacy profile.

Speaker #2: With regards to tolerability, the fact that we don't require these minimal residual disease surgeries during the treatment window is very well received. And for the competitor product, over 70% of their patients required surgery during their treatment window.

Jacqueline Shea: With regards to tolerability, the fact that we don't require these minimal residual disease surgeries during the treatment window is very well received. For the competitor product, over 70% of their patients required surgery during their treatment window, requiring one or more surgeries during that treatment window. That number was actually 83%, and it was 72% of their complete responders. As you can see, the competitor product patients receiving the competitor product in their trial actually required a lot of surgery during the dosing window. The fact that INO-3107 doesn't require these surgeries to maintain minimal residual disease is very attractive.

Jackie Shea: With regards to tolerability, the fact that we don't require these minimal residual disease surgeries during the treatment window is very well received. For the competitor product, over 70% of their patients required surgery during their treatment window, requiring one or more surgeries during that treatment window. That number was actually 83%, and it was 72% of their complete responders. As you can see, the competitor product patients receiving the competitor product in their trial actually required a lot of surgery during the dosing window. The fact that INO-3107 doesn't require these surgeries to maintain minimal residual disease is very attractive.

Speaker #2: Requiring one or more surgeries during that treatment window. Actually, sorry, that number was actually 83%, and it was 72% of their complete responders. So, as you can see, the competitor product patients receiving the competitor product in their trial actually required a lot of surgery during the dosing window.

Speaker #2: And the fact that INO-3107 doesn't require these surgeries and maintains minimal residual disease is very attractive. And then, as I think Steve mentioned, it's our ability to administer 3107 in the doctor's office, and the simple, patient-centric treatment regimen again is very attractive to patients.

Jacqueline Shea: As I think Steve mentioned, it's, you know, our ability to administer INO-3107 in the doctor's office and the simple patient-centric treatment regimen is again very attractive to patients. Steve, anything else you want to add to that?

Jackie Shea: As I think Steve mentioned, it's, you know, our ability to administer INO-3107 in the doctor's office and the simple patient-centric treatment regimen is again very attractive to patients. Steve, anything else you want to add to that?

Speaker #2: Steve, is there anything else you want to add to that?

Speaker #8: No, I think you covered it. I mean, the research has shown really, repeatedly, a lot of evidence that we have the potential to be the preferred product in this space.

Steven Egge: No, I think you covered it. I mean, you know, the research has shown really repeatedly a lot of evidence that, you know, we have the potential to be the preferred product in this space.

Steve Egge: No, I think you covered it. I mean, you know, the research has shown really repeatedly a lot of evidence that, you know, we have the potential to be the preferred product in this space.

Speaker #6: Great. Super helpful. Thanks again for taking the questions.

Jay Olson: Great. Super helpful. Thanks again for taking the questions.

Speaker #4: And thank you. We have our next question from Sudan Loganathan with Stevens.

Operator: Thank you. We have our next question from Sudhan Loganathan with Stephens.

Keith Avon: Thank you for taking my question. This is Keith Avon for Sudhan, and congrats on wrapping up the quarter. Just a quick one. As you engage with the third-party logistics and commercial partners ahead of launch, how are you specifically using those partners to incorporate learnings from the Papzimeos rollout to inform your distribution strategy, site activation plannings, reimbursement approach, and overall launch execution for INO-3107? Thank you.

Speaker #7: Hey. Thank you for taking my question. This is Keith Avon for Sudan and congrats on wrapping up the quarter. Just a quick one. So as you engage with the third-party logistics and commercial partners ahead of launch, how are you specifically using those partners to incorporate learnings from the PAPs/IMEOs rollout to inform your distribution strategy site activation plannings, reimbursement approach, and overall launch execution for 3107?

Keith Abell: Thank you for taking my question. This is Keith Avon for Sudhan, and congrats on wrapping up the quarter. Just a quick one. As you engage with the third-party logistics and commercial partners ahead of launch, how are you specifically using those partners to incorporate learnings from the Papzimeos rollout to inform your distribution strategy, site activation plannings, reimbursement approach, and overall launch execution for INO-3107? Thank you.

Speaker #7: Thank you.

Speaker #2: Steve, sure. So yeah, I mean, obviously, we would we're watching carefully what our competitor is doing and learning from that. I don't know that they're necessarily the same commercial partners for us that you're using.

Steven Egge: Sure. Yeah, I mean, obviously we would, you know, we're watching, you know, carefully what our competitor is doing and learning from that. I don't know that they're necessarily the same, you know, commercial partners that Precigen is using. They have, you know, very deep, broad experience in the rare disease space. We're learning from that as well. I would say the more general rare disease experience, but also Precigen's experience as well, to do everything that we can to ensure that we're kind of very well prepared, from a launch standpoint.

Steve Egge: Sure. Yeah, I mean, obviously we would, you know, we're watching, you know, carefully what our competitor is doing and learning from that. I don't know that they're necessarily the same, you know, commercial partners that Precigen is using. They have, you know, very deep, broad experience in the rare disease space. We're learning from that as well. I would say the more general rare disease experience, but also Precigen's experience as well, to do everything that we can to ensure that we're kind of very well prepared, from a launch standpoint.

Speaker #2: But they have very deep, broad experience in the rare disease space, so we're learning from that as well. So I would say the more general rare disease experience, but also Precedence experience as well.

Speaker #2: To do everything that we can to ensure that we're kind of very well prepared from a launch standpoint.

Speaker #9: And if I can add, there were some key differences with 3107 to PAPs/IMEOs. We don't require any ultracold chain, so we don't have those logistical issues setting up an ultracold chain.

Jacqueline Shea: If I can add, you know, there are some key differences with INO-3107 to Papzimeos. We don't require any ultra cold chain. Also, we don't have those logistical issues setting up an ultra cold chain. Also, as we don't require these minimal residual disease surgeries during the treatment window, physicians don't have to plan for scoping and possibly doing surgery as well, which obviously makes the treatment regimen very attractive to physicians and to patients.

Jackie Shea: If I can add, you know, there are some key differences with INO-3107 to Papzimeos. We don't require any ultra cold chain. Also, we don't have those logistical issues setting up an ultra cold chain. Also, as we don't require these minimal residual disease surgeries during the treatment window, physicians don't have to plan for scoping and possibly doing surgery as well, which obviously makes the treatment regimen very attractive to physicians and to patients.

Speaker #9: And also, as we don't require these minimal residual disease surgeries during the treatment window, physicians don't have to plan for scoping and possibly doing surgery as well, which obviously makes the treatment regimen very attractive to physicians and to patients.

Keith Avon: Okay. Thank you.

Keith Abell: Okay. Thank you.

Speaker #7: you.

Speaker #4: And thank you. Our next question is from Roger Song with Jefferies.

Operator: Thank you. Our next question is from Roger Song with Jefferies.

Speaker #10: Hey, good afternoon, team. Thanks for taking that question. This is Nabil on for Roger. I had a question on the Keyso partnership. If you could just kind of walk us through that biological rationale of the dual PD1 TCLA4 blockade.

Nabil Nassar: Hey, good afternoon, team. Thanks for taking my question. This is Nabil on for Roger. Had a question on the Akeso partnership. If you could just kinda walk us through that biological rationale of the dual PD-1 CTLA-4 blockade. How does that sort of add on top of the T-cell priming that you've shown before with INO-5412 in GBM?

Speaker #10: How does that sort of add on top of the T-cell priming that you've shown before with 5412 and GBM?

Speaker #2: Yeah. Great question. So in the previous study, we combined 5401 plus IL-12 plus a PD1 inhibitor from Regeneron called Lipteo. And what we saw in that study was encouraging data where we saw beneficial patient outcomes linked to the immune responses against the antigens that were encoded within 5401.

Jacqueline Shea: Yes, great question. In the previous study, we combined INO-5401 plus IL-12 plus a PD-1 inhibitor from Regeneron called Libtayo. What we saw in that study was encouraging data where we saw beneficial patient outcomes linked to the immune responses against the antigens that were encoded within INO-5401. By partnering with Akeso in this innovative trial, what we're hoping is that the CTLA-4 element, in addition to the PD-1 inhibition, by providing an additional pathway for checkpoint inhibition, will allow those immune responses against the tumor-associated antigens to provide additional benefit. We're excited to be partnering with Akeso and excited to get this study underway. Mike, anything else you would like to add?

Jackie Shea: Yes, great question. In the previous study, we combined INO-5401 plus IL-12 plus a PD-1 inhibitor from Regeneron called Libtayo. What we saw in that study was encouraging data where we saw beneficial patient outcomes linked to the immune responses against the antigens that were encoded within INO-5401. By partnering with Akeso in this innovative trial, what we're hoping is that the CTLA-4 element, in addition to the PD-1 inhibition, by providing an additional pathway for checkpoint inhibition, will allow those immune responses against the tumor-associated antigens to provide additional benefit. We're excited to be partnering with Akeso and excited to get this study underway. Mike, anything else you would like to add?

Speaker #2: So by partnering with a Keyso in this innovative trial, what we're hoping is that the CTL4 element, in addition to the PD1 inhibition, by providing an additional pathway for checkpoint inhibition, will allow those immune responses against the tumor-associated antigens to provide additional benefit.

Speaker #2: So we're excited to be partnering with a Keyso and excited to get this study underway. Mike, anything else you would like to add?

Speaker #6: No, I think the only point, I mean, it's well established that there is significant synergism between CTLA4 and PD1. So as Jacqui said, we think it will be a very nice combination to 5412.

Michael Sumner: No, I think that's the only point. I mean, it's well established that there is significant synergism between CTLA-4 and PD-1. As Jackie said, we think it'll be a very nice combination to INO-5412.

Mike Sumner: No, I think that's the only point. I mean, it's well established that there is significant synergism between CTLA-4 and PD-1. As Jackie said, we think it'll be a very nice combination to INO-5412.

Speaker #10: Yeah, that's exciting. A follow-up on that, I think Insight historically, you guys emphasized the 06-methylguanine methyltransferase unmethylated group. Any idea this is early, but in terms of subgroups, does methylation status influence any expectations for the immunotherapy responsiveness?

Nabil Nassar: Yeah, that's exciting. A follow-up on that. I think INSIGhT, historically, you guys emphasized the O6-methylguanine methyltransferase unmethylated group. Any idea, this is like early, but in terms of subgroups, like does the methylation status influence any expectations for like the immunotherapy responsiveness? Thank you.

Speaker #10: Thank you.

Speaker #2: Yeah. So in the prior trial, we saw benefits in both methylated and unmethylated groups. So we were very encouraged by that data. Sorry, Mike, you wanted to say something?

Jacqueline Shea: Yes. In the prior trial, we saw benefits in both methylated and unmethylated groups. We were very encouraged by that data. Sorry, Mike, you wanted to say something?

Jackie Shea: Yes. In the prior trial, we saw benefits in both methylated and unmethylated groups. We were very encouraged by that data. Sorry, Mike, you wanted to say something?

Michael Sumner: No, I was gonna say exactly the same. The INSIGhT trial is actually in the unmethylated population. You know, while it's very sad for the patients, that will lead to a quicker readout as they have a poorer prognosis.

Mike Sumner: No, I was gonna say exactly the same. The INSIGhT trial is actually in the unmethylated population. You know, while it's very sad for the patients, that will lead to a quicker readout as they have a poorer prognosis.

Speaker #7: I was going to say exactly the same. But the Insight trial is actually in the unmethylated population. So, while it's very sad for the patients, that will lead to a quicker readout as they have a poorer prognosis.

Speaker #10: Thank you for the follow-up. Appreciate it.

Nabil Nassar: Thank you for the color. Appreciate it.

Speaker #4: And thank you. We have our next question from Yichen with HG Wainwright.

Operator: Thank you. We have our next question from Yi Chen with H.C. Wainwright.

Speaker #9: Hi. This is Katie on for Yi. Taking a look at your pipeline, if 3107 is approved, what are your plans to move forward with 3112?

[Analyst] (H.C. Wainwright): Hi, this is Katie on for Yi Chen. Taking a look at your pipeline, if INO-3107 is approved, what are your plans to move forward with INO-3112? Are you guys planning to reinvest internally or seek partnership for that type of program?

Katie Xu: Hi, this is Katie on for Yi Chen. Taking a look at your pipeline, if INO-3107 is approved, what are your plans to move forward with INO-3112? Are you guys planning to reinvest internally or seek partnership for that type of program?

Speaker #9: Are you guys planning to reinvest internally, or seek partnership for that type of program?

Speaker #2: Yeah, great question. So for those of you who are not familiar, 3112 is our program in HP16 and 18-positive head and neck cancer or pharyngeal squamous cell carcinoma.

Jacqueline Shea: Yeah, great question. For those of you who are not familiar, INO-3112 is our program in HPV 16 and 18 positive head and neck cancer, oropharyngeal squamous cell carcinoma. We announced a partnership with Coherus for their PD-1 inhibitor LOQTORZI, which is approved in nasopharyngeal carcinoma. We're looking to start a phase 3 trial. However, at the moment, the vast majority of our resources are going towards moving INO-3107 forward. Should INO-3107 be approved later on this year and we have sufficient financial resources available, then we'll be looking to move forward the other candidates in our pipeline. We're very excited by our later-stage candidates, which are predominantly focused on T-cell mechanisms.

Jackie Shea: Yeah, great question. For those of you who are not familiar, INO-3112 is our program in HPV 16 and 18 positive head and neck cancer, oropharyngeal squamous cell carcinoma. We announced a partnership with Coherus for their PD-1 inhibitor LOQTORZI, which is approved in nasopharyngeal carcinoma. We're looking to start a phase 3 trial. However, at the moment, the vast majority of our resources are going towards moving INO-3107 forward. Should INO-3107 be approved later on this year and we have sufficient financial resources available, then we'll be looking to move forward the other candidates in our pipeline. We're very excited by our later-stage candidates, which are predominantly focused on T-cell mechanisms.

Speaker #2: And there, we announced a partnership with Kahera for their PD1 inhibitor LOCTORZI, which is approved in nasopharyngeal carcinoma. We're looking to start a phase three trial; however, at the moment, the vast majority of our resources are going towards moving 3107 forward.

Speaker #2: So should 3107 be approved later on this year, and we have sufficient financial resources available, then we'll be looking to move forward the other candidates in our pipeline.

Speaker #2: But we're very excited by our latest-stage candidates, which are predominantly focused on T-cell mechanisms. So 3107, 5401, 3112, all focused on driving T-cell responses.

Jacqueline Shea: INO-3107, INO-5401, INO-3112, all focused on driving T-cell responses either against viral antigens or against cancer antigens. We also have our earlier stage pipeline around our dPROT and our dMAb candidates, where we're looking to move those candidates into the clinic through partnerships. Partnerships are gonna be very important to us in terms of how we see our pipeline developing going forward.

Jackie Shea: INO-3107, INO-5401, INO-3112, all focused on driving T-cell responses either against viral antigens or against cancer antigens. We also have our earlier stage pipeline around our dPROT and our dMAb candidates, where we're looking to move those candidates into the clinic through partnerships. Partnerships are gonna be very important to us in terms of how we see our pipeline developing going forward.

Speaker #2: Either against viral antigens or against cancer antigens. And then we also have our earliest-stage pipeline, around our DPROT and our DMAP candidates, where we're looking to move those candidates into the clinic through partnerships.

Speaker #2: So, partnerships are going to be very important to us in terms of how we see our pipeline developing going forward.

Speaker #9: Great. Thank you so much.

[Analyst] (H.C. Wainwright): Great. Thank you so much.

Katie Xu: Great. Thank you so much.

Speaker #2: Thank you.

Jacqueline Shea: Thank you.

Jackie Shea: Thank you.

Speaker #4: Thank you. We have no further questions. I will now turn the call over to Jacqui Shea for closing remarks.

Operator: Thank you. We have no further questions. I will now turn the call over to Jacqueline Shea for closing remarks.

Speaker #2: Thank you. As we've outlined here today, our strategic focus for the months ahead is clear. Advancing the BLA review for 3107 and optimizing our resources to extend our cash runway towards our October 30th PDUPA date.

Jacqueline Shea: Thank you. As we've outlined here today, our strategic focus for the months ahead is clear. Advancing the BLA review for INO-3107 and optimizing our resources to extend our cash runway towards our 30 October PDUFA date. At the same time, we'll continue driving progress across our pipeline where possible, leveraging partnership opportunities and the potential of our platform in GBM, hemophilia, and other rare diseases. As I close today, I'd like to reiterate our belief that INO-3107 can address the unmet needs of RRP patients who have faced the risks and burdens of their disease for far too long. We're moving forward, committed to making sure that every patient can find the relief from repeated surgery that they deserve. Thank you for your attention and good evening, everyone.

Jackie Shea: Thank you. As we've outlined here today, our strategic focus for the months ahead is clear. Advancing the BLA review for INO-3107 and optimizing our resources to extend our cash runway towards our 30 October PDUFA date. At the same time, we'll continue driving progress across our pipeline where possible, leveraging partnership opportunities and the potential of our platform in GBM, hemophilia, and other rare diseases. As I close today, I'd like to reiterate our belief that INO-3107 can address the unmet needs of RRP patients who have faced the risks and burdens of their disease for far too long. We're moving forward, committed to making sure that every patient can find the relief from repeated surgery that they deserve. Thank you for your attention and good evening, everyone.

Speaker #2: At the same time, we'll continue driving progress across our pipeline where possible, leveraging partnership opportunities and the potential of our platform in GBM, haemophilia, and other rare diseases.

Speaker #2: As I close today, I'd like to reiterate our belief that 3107 can address the unmet needs of our RP patients—patients who have faced the risks and burdens of their disease for far too long.

Speaker #2: We're moving forward, committed to making sure that every patient can find the relief from repeated surgery that they deserve. Thank you for your attention.

Speaker #2: And good evening, everyone.

Operator: Thank you, ladies and gentlemen. This concludes our conference call. We thank you for your participation. You may now disconnect.

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