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Inovio Pharmaceuticals (NASDAQ: INO)
Q3 2024 Earnings Call
Nov 14, 2024, 4:30 p.m. ET
Inovio Pharmaceuticals Reports Q3 2024 Earnings: Progress on Key Products and Future Outlook
Content Summary
- Prepared Remarks
- Questions and Answers
- Call Participants
Prepared Remarks:
Operator
Good afternoon, ladies and gentlemen, and welcome to the Inovio third quarter 2024 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. [Operator instructions] This call is being recorded on Thursday, November 14th, 2024.
I would now like to turn the conference over to Thomas Hong, manager of investor relations. Please go ahead.
Thomas Hong — Manager, Investor Relations
Good afternoon and thank you for joining the Inovio third quarter 2024 financial results conference call. Joining me on today’s call are Dr. Jackie Shea, president and chief executive officer; Dr. Mike Sumner, chief medical officer; Peter Kies, chief financial officer; Steve Egge, chief commercial officer; and Dr. Matthew Morrow, VP of translational sciences. Today, we will review our corporate and financial information for the quarter ended September 30th, 2024, and provide a general business update. Following prepared remarks, we will conduct a question-and-answer segment. During the call, we will share forward-looking statements regarding future events and the company’s performance.
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We remind all listeners that the statements made today relate to our plans for Inovio’s DNA medicines platform, covering clinical developments, regulatory submissions, and other strategic matters. Actual results may differ from those expressed today. For more details, please refer to our SEC filings, particularly the risk factors section.
This call is being webcast live, and a link is available on our website, ir.inovio.com. A replay will be available shortly after this call concludes. I will now hand it over to Inovio’s President and CEO, Dr. Jackie Shea.
Jackie Shea — President and Chief Executive Officer
Good afternoon, and thank you for joining today’s call. This quarter, we continued to make progress on key objectives aimed at enhancing shareholder value and fulfilling the promise of DNA medicine for patients. Our focus areas this year include advancing our lead product candidate, INO-3107, toward commercialization, enhancing our pipeline, and strengthening our overall business.
Recently, we announced significant new immunology data that supports the mechanism of action for INO-3107 and its potential to reduce surgeries for patients with recurrent respiratory papillomatosis (RRP). This data emphasizes the drug’s ability to stimulate T-cell responses, which correspond to clinical benefits observed in our phase 1/2 trial. We presented this information at notable scientific conferences, including the International Papillomavirus Conference earlier this week.
We also shared comprehensive safety and efficacy data demonstrating that INO-3107 is well-tolerated and beneficial in our trials. This robust data strengthens our belief that 3107 could become the preferred treatment option for many RRP patients if approved. My colleagues Mike and Steve will delve deeper into this shortly.
Regarding regulatory progress, we had a constructive pre-BLA meeting with the FDA in August. We are diligently preparing to submit our Biologics License Application (BLA), targeted for mid-2025. We anticipate concluding all non-device-related modules by the year-end. You may recall from our last call that we identified a manufacturing issue related to a single-use component of our device during testing for the BLA submission. We have since identified a solution and are effectively implementing it.
In summary, we remain optimistic about bringing INO-3107 to the market as a vital treatment option for patients suffering from this challenging condition. While we concentrate on 3107, we also recognize the potential in our broader pipeline and have made notable progress on other candidates. For INO-3112, we’ve engaged with European regulators concerning the design of a proposed phase 3 trial for treating advanced HPV16 and 18 positive oropharyngeal squamous cell carcinoma, also referred to as throat cancer. We expect to conduct this trial in North America and Europe, with earlier discussions with the FDA indicating alignment on the trial’s design.
Continuing in oncology for INO-5401, we are actively dosing patients in the GBM-001 trial for newly diagnosed glioblastoma, which combines 5401 with Regeneron’s PD-1 checkpoint inhibitor, Libtayo. Both companies have discussed the next steps for this trial, and we view this collaboration as critical.
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Inovio Pharmaceuticals Explores Innovative Treatments and Reports Positive Trial Results
The company continues to make strides in developing treatments for rare diseases while maintaining fiscal responsibility.
Inovio Pharmaceuticals is currently conducting a separate trial for their drug 5401, aimed at patients with the BRCA mutation. This important research is being carried out at the Basser Center at the University of Pennsylvania. In addition, the company is preparing for an upcoming meeting with the FDA later this quarter to discuss the design of a Phase 2 trial for INO-4201, which will serve as an additional booster alongside the FDA-licensed Ebola vaccine, Ervebo. From earlier-stage candidates, Inovio anticipates clinical data from a Phase 1 study focused on DNA-encoded monoclonal antibodies will be submitted for peer-reviewed publication by the end of the year. This submission will mark a significant milestone as it represents the first clinical data for this innovative approach.
Inovio is committed to maintaining financial discipline while enhancing its business strategies. As of the end of the third quarter, the company reported $84.4 million in cash, cash equivalents, and short-term investments, all without any outstanding debt. I’ll now hand it over to Mike for further insights on the promising data regarding INO-3107.
Mike Sumner — Chief Medical Officer and RRP Program Lead
Thank you, Jackie. Before discussing the latest data presented at various scientific conferences recently, I want to underscore our dedication to treating patients with Recurrent Respiratory Papillomatosis (RRP). This rare disease, caused by the human papillomavirus (HPV), leads to the development of wart-like growths known as papillomas in the respiratory tract. Unfortunately, patients with RRP do not mount a sufficient immune response, allowing the papillomas to proliferate unchecked.
Consequently, patients may face challenges such as difficulty speaking, swallowing, and in severe cases, breathing issues. Currently, the primary treatment is surgical removal of these growths, but this approach does not address the underlying HPV infection, resulting in a continual cycle of surgeries. Each surgery carries risks, including potential vocal cord damage. Patients have expressed that even reducing surgeries by one could significantly improve their quality of life.
Our development efforts for INO-3107 focus on addressing this critical need. We believe that 3107 has the potential to transform the standard treatment for RRP. Designed to generate specific cytotoxic CD8 T cells targeting HPV-6 and HPV-11, this treatment offers a novel, non-surgical approach for patients. In our Phase 1/2 trial, we witnessed a remarkable combination of clinical benefits and tolerability across various severity levels of the disease, alongside a robust immune response that correlates with a reduction or elimination of surgical needs.
Our findings support the potential of 3107 to become the preferred treatment option for a majority of RRP patients. At conferences this October, we presented comprehensive safety and efficacy data, which underscores these points. In our trial, 81%—or 26 out of 32—of participants experienced a reduction in surgeries following 3107 administration compared to the previous year, including 28% who required no surgical intervention during or after treatment.
Furthermore, 44% of patients showed a partial response, defined as a decrease of at least 50% in surgical needs. Overall, we achieved a combined response rate of 72%, indicating meaningful benefits for patients. Every surgery’s significance has been carefully accounted for in our trial design, emphasizing our commitment to patient outcomes.
We also compiled safety data showing that 3107 was well tolerated, with the most frequent adverse effects reported as injection site pain in less than one-third of patients. The electroporation device, CELLECTRA, used for administering the treatment, was easily manageable for healthcare providers and well accepted by patients. Fatigue was noted in just three cases, and importantly, no serious treatment-related adverse events beyond grade 2 severity were reported.
One distinguishing feature of our DNA medicine platform is its capability to foster an effective T-cell response, critical in treating chronic viral diseases. The proposed operation mechanism for 3107 involves inducing HPV-specific T-cell responses that travel to and infiltrate papilloma and airway tissues, aiming to eradicate HPV-infected cells and ultimately reduce the necessity for surgeries. I’ll now share insights from our recent immunology data presented at the International Papilloma Virus Conference.
To better understand immune responses to 3107, we analyzed blood and tissue samples from participants in our Phase 1/2 trial. Our aim was to dissect the individual immune processes at play during treatment. We conducted extensive assessments to confirm the induction, activation, and growth of cytotoxic T-cells targeting HPV-6 and HPV-11 and to evaluate changes in these immune responses.
Our discoveries were highly encouraging, showing that 3107 effectively induces the desired HPV-specific T-cell responses that migrate to the papilloma and airway tissues. These specialized T-cells are crucial for eliminating HPV-infected cells and reducing the need for surgical intervention. Here are the key takeaways from our study:
First, INO-3107 generates suitable immune responses for most RRP patients. Our research revealed HPV-6 and HPV-11 antigen-specific cytotoxic T-cells with durable responses lasting up to 52 weeks, indicating lasting immunity crucial for managing chronic diseases like RRP. Second, these newly generated T-cells reach their target sites effectively. Our data confirmed that they move from the blood into the papilloma and surrounding tissues, instigating the desired inflammatory and antiviral responses.
Third, the immune response observed was specific to INO-3107 treatment, marked by the emergence of new T-cell clones in blood samples that were absent prior to treatment, correlating with the clinical improvements noted in trial participants. Fourth, we could differentiate immune responses between treatment responders and non-responders, demonstrating notable variations in the size and timing of the response. This comprehensive data reinforces the therapeutic potential of INO-3107 and aims to offer a new lease on life for RRP patients.
Inovio Pharmaceuticals Reveals Promising Data for INO-3107, Targeting HPV-Related RRP
New Insights on RRP Treatment Offer Hope
Inovio Pharmaceuticals has shared exciting updates regarding INO-3107, a treatment aimed at recurrent respiratory papillomatosis (RRP) caused by HPV strains 6 and 11. Recent immunology data suggests the treatment effectively activates T-cells to combat the HPV virus, potentially reducing the need for frequent surgeries.
The ongoing evaluations of the papilloma microenvironment have not shown limiting factors to the effectiveness of INO-3107. Currently, the immunology data is under review for publication in a peer-reviewed journal. This information will be critical for the upcoming Biologics License Application (BLA) for INO-3107.
Key Findings on INO-3107’s Efficacy
Data supports that INO-3107 effectively targets the HPV-6 and HPV-11 strains, considerably connected to RRP. The findings also suggest that the treatment can provide benefits across various levels of disease severity. Physicians have noted that every surgery counts for patients, reinforcing the importance of treatments that could potentially lessen surgical frequency.
Ultimately, Inovio believes that, if approved, INO-3107 could significantly change the treatment landscape for RRP, drastically minimizing the surgical interventions needed by patients. Additionally, Inovio recently wrapped up a retrospective study assessing the long-term response to previous treatments from their phase 1/2 study, with results expected by year-end.
Commercial Strategy for Upcoming Launch
Steve Egge, Inovio’s Chief Commercial Officer, highlighted the ongoing preparations for the rollout of INO-3107, contingent on FDA approval. The commercial strategy is centered on understanding the needs of healthcare providers, payers, and patients through comprehensive market research.
Feedback from patients emphasizes that even a slight reduction in surgery frequency can significantly improve their quality of life. Inovio aims to set pricing consistent with current rare disease standards, confirmed acceptable by major U.S. payers. Strategic decisions around distribution and product positioning are being made to ensure competitive advantage and a positive customer experience.
The FDA has indicated that Inovio’s proposed brand name for INO-3107 is acceptable, although it will be finalized during the BLA process. Inovio anticipates full readiness for the launch by the end of 2025, planning for an efficient commercial operation.
Financial Overview for Q3 2024
Peter Kies, the Chief Financial Officer, provided an update on Inovio’s financial position. For the third quarter ending September 30, 2024, operating expenses have decreased by 24%, from $35.9 million in Q3 2023 to $27.3 million in Q3 2024. The net loss for this quarter also improved, landing at $25.2 million, or $0.89 per share, down from a net loss of $33.9 million, or $1.52 per share one year earlier.
By the end of Q3 2024, Inovio had $84.8 million in cash and short-term investments, a decline from $145.3 million as of December 31, 2023. The company estimates a cash runway extending into Q3 2025, projecting a operational net cash burn of approximately $24 million for Q4 2024.
Further financial details are accessible in the press release and the Form 10-Q filed with the SEC.
Q&A Session
Operator
Thank you, ladies and gentlemen. We’re now starting the question-and-answer portion of the call. [Operator instructions]. Your first question comes from Jay Olson at Oppenheimer.
Jay Olson — Analyst
Congratulations on the progress with your BLA filing for 3107 in the U.S. What updates do you have regarding regulatory efforts outside of the U.S., particularly in the EU and U.K., as well as Japan and China?
Jackie Shea — President and CEO
Hi, Jay. Nice to connect. Mike, could you share the status of our international regulatory filings?
Mike Sumner — Chief Medical Officer and RRP Program Lead
Sure. We had discussions with the U.K. regulators, who echoed similar concerns as their EU counterparts, stating that compelling placebo-controlled data will be vital for approvals in those regions. Hence, the ongoing placebo-controlled study not only aims for U.S. approvals but will also be applicable in these other markets. Completion of this study will be essential before we submit any applications.
Jay Olson — Analyst
As discussions around potential expansions into Europe continue, we still haven’t engaged with Japan and China. However, both regions show an interest in RRP. We’ve communicated with key opinion leaders in these areas, which remain priorities for our growth.
Jackie Shea — President and Chief Executive Officer
Thank you, Jay. It’s an exciting time for us following our recent presentations at AACR and IPVC. The feedback from physicians has been overwhelmingly positive regarding the new immunology data. Mike, would you like to provide more insights?
Mike Sumner — Chief Medical Officer and RRP Program Lead
Absolutely. The data highlights the effective mechanism of action of 3107, and it’s resonating well with both clinicians and scientists. They appreciate how our data connects immunological concepts with practical clinical outcomes. This connection is crucial as we prepare for our Biologics License Application (BLA), aligning clinical data with Immunological findings.
Jackie Shea — President and Chief Executive Officer
Additionally, we have noted significant interest from key specialists in the field, evidenced by Professor Steinberg’s remarks in our recent press release. There is a strong consensus that our product could be a breakthrough for treating RRP.
Jay Olson — Analyst
That’s great to hear. Thank you for your insights, and congratulations on the ongoing progress.
Jackie Shea — President and Chief Executive Officer
Thank you, Jay.
Operator
Your next question comes from Roy Buchanan from Citizens JMP. Your line is now open.
Roy Buchanan — Analyst
Thanks for taking my questions. To start, can you elaborate on the steps you’re taking to resolve the manufacturing issues with 3107?
Jackie Shea — President and Chief Executive Officer
Hi, Roy. It’s nice to connect. We’ve encountered manufacturing issues related to a single-use component earlier this summer, just before our previous meeting. We’ve been working diligently to identify and implement appropriate solutions, and significant progress is being made.
Roy Buchanan — Analyst
Understood. I believe the start of the phase 3 trial for 3112 is also contingent on resolving this manufacturing issue. Given that the device is approved in Europe, is there a chance you could initiate the phase 3 trial there first? When might that occur?
Jackie Shea — President and Chief Executive Officer
Great question, Roy. Indeed, the initiation of the phase 3 trial for 3112 hinges on resolving the device issue. Mike, could you give more context on our regulatory discussions in Europe?
Mike Sumner — Chief Medical Officer and RRP Program Lead
Sure, we have reached alignment with the FDA regarding our study design. Ongoing discussions with the EMA are expected to yield feedback soon. Given the global prevalence of HPV-related diseases and the rising incidence of throat cancer in high-income regions, running the study in both areas is crucial, and we hope to provide updates in our next call.
Roy Buchanan — Analyst
Thank you. I will jump back into the queue for now.
Operator
Your next question comes from Sudan Loganathan from Stephens. Your line is now open.
Sudan Loganathan — Analyst
Thank you for your time. Can you discuss how your product 3107 compares to Precigen’s 2012 in terms of competition?
Jackie Shea — President and Chief Executive Officer
Absolutely. We’re confident in the product profile of 3107 and believe it will position us favorably against competitors. Our regimen’s focus on delivering clinical benefits across different disease severities and types is a key differentiator. In contrast, Precigen’s approach employs a gorilla adenovirus vector, which fundamentally alters its delivery method.
Mike Sumner — Chief Medical Officer and RRP Program Lead
Indeed, the treatment pathways differ significantly. While both products have four doses, Precigen’s protocol includes proactive procedures that can impact overall surgery counts. We’ve made a different commitment to count every relevant surgery post-treatment.
Sudan Loganathan — Analyst
Thank you for the clarification. Regarding the manufacturing issue, are you considering changing your current manufacturer for the plastic molding component?
Jackie Shea — President and Chief Executive Officer
We are currently focused on resolving the existing issues with our current manufacturer instead of pursuing a change. We’ve identified the problem related to the single-use component and are working closely with them to implement solutions.
Sudan Loganathan — Analyst
Thank you. I appreciate your detailed responses.
Insights on 3107 and Regulatory Progress from Company Executives
Operator
Your next question comes from Liang Cheng from Jefferies. Your line is now open.
Liang Cheng — Jefferies — Analyst
Thank you for the opportunity to ask questions. This is Liang Cheng for Roger at Jefferies. My first question is about 3107. Can you provide an update on the confirmatory trial? Are you sticking with the original design, or do you plan to incorporate redosing? Additionally, regarding the immunology study, have you analyzed the differences between responders and non-responders? Any observations there would be appreciated. Thanks.
Jackie Shea — President and Chief Executive Officer
Thank you for your question. We’ve shared our thoughts on the confirmatory trial design. Mike, could you elaborate on this and why we chose this approach?
Mike Sumner — Chief Medical Officer and RRP Program Lead
Of course. Our discussions with regulatory agencies highlighted the need for a placebo-controlled study if we aim for an indication similar to what we measured in our phase 1/2 trial, specifically involving two surgeries in the previous year. This has led us to opt for a randomized study, which we feel confident in based on our clinical findings.
We are planning a relatively small trial with about 100 patients, applying a two-to-one randomization. Currently, we do not intend to include redosing, as previous patients treated with an HPV-6-only plasmid have shown efficacy lasting 500 to over 800 days.
In discussions with the agency, they indicated a preference for a longer follow-up period than we had during the phase 1/2 study. This motivated us to conduct a retrospective study, which we expect to report on by the end of the year. We believe it’s crucial to analyze the benefits of 3107 over a longer period, justifying our study design choice.
Jackie Shea — President and Chief Executive Officer
Thanks, Mike. I’ll briefly address the immunology findings before inviting Matthew to provide more details. Yes, we have examined the differences between responders and non-responders. We collected two sample types: peripheral blood samples throughout the trial, and paired tissue samples from the airways, taken before treatment and after 52 weeks. We noticed differing immune responses in responders versus non-responders, which seem to correlate with clinical outcomes.
Matthew Morrow — Vice President, Translational Sciences
Good afternoon. Building on what Jackie said, we’ve observed that the tissue responses in responders display noticeable differences compared to non-responders. These variations include differences in the infiltration of T-cells, their functionality, and overall inflammatory responses, particularly around interferon alpha and interferon-gamma levels. We plan to provide further details in an upcoming publication.
Liang Cheng — Jefferies — Analyst
Thank you, that’s very informative. Now, regarding 3112, what feedback have you received from EU regulators about the next steps before cloud initiation?
Jackie Shea — President and Chief Executive Officer
Mike, would you like to address that?
Mike Sumner — Chief Medical Officer and RRP Program Lead
Absolutely. Our discussions aim to align on the strategic design of 3112. We have included insights from global Key Opinion Leaders in the study design, which gives us confidence in their inclusivity. We are optimistic about reaching alignment with the regulatory bodies.
Practically, we will need to submit a clinical trial application to the EMA before recruiting participants.
Liang Cheng — Jefferies — Analyst
Understood. Thank you, Mike. That’s all from me for now.
Operator
Your next question comes from Yi Chen from H.C. Wainwright. Your line is now open.
Unknown speaker — — Analyst
Hello, this is Eduardo stepping in for Yi. Thank you for taking my question. Could you clarify the timeline for starting the confirmatory trial for 3107 and how it aligns with the BLA submission you’ve mentioned?
Jackie Shea — President and Chief Executive Officer
This is an excellent question, Eduardo. We aim to submit our Biologics License Application (BLA) around mid-2025. The FDA has laid out that we must begin our confirmatory trial before moving forward with the BLA submission. We plan to request rolling submission priority review as part of that process.
So, to reiterate, we are looking at mid-2025 for the BLA submission.
Unknown speaker — — Analyst
Great. Thank you.
Mike Sumner — Chief Medical Officer and RRP Program Lead
To add more context, the FDA emphasized the need for us to initiate this study soon. They’ve noted that many sponsors struggle to provide their confirmatory studies in a timely manner. In contrast, we are nearly ready, having identified almost all our sites and already submitted applications for institutional review boards.
Jackie Shea — President and Chief Executive Officer
Exactly, Mike. Our prior experience with the phase 1/2 study in the U.S. involved collaborations with eight top clinical trial centers specializing in RRP treatment. This experience should facilitate our work across varied sites in the upcoming study.
Unknown speaker — — Analyst
Thanks for the clarification.
Operator
Your next question comes from Gregory Renza from RBC Capital Markets. Your line is now open.
Anish Nikhanj — Analyst
Hi team, Anish here for Greg. Thank you for taking my questions. Regarding 3107 and the selector device, can you remind us of the duration of adverse events like injection site pain and fatigue? How quickly do these resolve, and what does this mean for patient and physician expectations when using the selector device? Considering that Precigen is also potentially launching in 2025, how are you planning your commercial strategy to compete effectively in a market that may already have a competitor? Thank you.
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Company 3107’s Promising Profile and Future Potential Unveiled in Earnings Call
Jackie Shea — President and Chief Executive Officer
Thank you, Anish, for the insightful questions. Mike, let’s delve deeper into our findings regarding 3107’s safety data.
Mike Sumner — Chief Medical Officer and RRP Program Lead
Of course. In our trial, only 41% of patients experienced treatment-related side effects. Notably, 10 out of 32 patients reported injection site pain, and just one of these instances reached a severity level of grade 2. The majority were assessed as grade 1. Previous studies involving electroporation indicated that most injection site pain subsides within 5 to 10 minutes. As we launch this device, we’ll prioritize educating both patients and physicians to set realistic expectations, which is critical given that this is a new procedure.
Jackie Shea — President and Chief Executive Officer
It’s essential to emphasize, Mike, that these side effects are quick to resolve. Feedback from patients suggests that the treatment is manageable. Healthcare providers also report that our device is user-friendly. Given how severely RRP affects patients, the rapid alleviation of side effects is crucial. Anish, does this clarify your questions regarding the 3107 profile? We can move on after this to discuss our 2025 launch strategy.
Anish Nikhanj — Analyst
Yes, that would be great, thank you.
Jackie Shea — President and Chief Executive Officer
As I mentioned earlier, we believe that 3107 boasts an appealing product profile, positioning it as the preferred option for many patients and doctors. I’ll let Steve provide further details. However, available data from Precigen remains limited at this point, and we await the full data set from the second patient cohort. The distinction between our treatment methods will be intriguing. Additionally, the durability data we plan to announce later this year will also be significant.
Steve Egge — Chief Commercial Officer
At this stage, we cannot confirm whether Precigen will enter the market ahead of us. Regardless, we intend to deploy medical science liaisons (MSLs) and national account managers to engage health plans prior to our approval. We are confident in our product’s strong differentiation based on current data. There’s marked demand in the market due to the significant burden associated with surgical interventions. Therefore, as soon as we receive approval, we will be ready to advocate for 3107.
Anish Nikhanj — Analyst
Perfect, thank you.
Operator
The next question comes from Roy Buchanan at Citizens JMP.
Roy Buchanan — Analyst
Thanks for letting me follow up. I believe you mentioned running a separate trial for redosing with 3107. Is that expected to happen alongside the confirmatory trial, or will it take place afterward?
Jackie Shea — President and Chief Executive Officer
Mike, could you elaborate on the redosing strategy?
Mike Sumner — Chief Medical Officer and RRP Program Lead
Absolutely. Our approach involves commencing redosing studies with commercial patients as soon as we launch. We believe that complete responders may benefit from continued dosing. Recent discussions at IPVC focused on whether it’s possible to eliminate all HPV-infected cells, a scientific question that could be explored through ongoing treatment. However, this work will take time, commencing post-launch.
Roy Buchanan — Analyst
Thank you.
Operator
There are no further questions at this time. I’ll turn the call back over to Jackie Shea for closing remarks. Please proceed.
Jackie Shea — President and Chief Executive Officer
Thank you for your attention. Today’s immunology data adds to a growing body of evidence showcasing the potential of 3107 to transform treatment for patients affected by RRP. We are committed to moving quickly to achieve crucial milestones, including publishing new immunology data, sharing updated durability insights, submitting our Biologics License Application (BLA), and preparing for a potential launch in late 2025, provided we receive the necessary approvals. Simultaneously, we are evaluating other key candidates and ways to strengthen our financial position as we move forward.
As we wrap up this year, I am proud of our significant progress over the past 12 months, and we aim to maintain this momentum into the next year. Thank you, everyone, and have a good evening.
Operator
[Operator signoff]
Duration: 0 minutes
Call Participants:
Thomas Hong — Manager, Investor Relations
Jackie Shea — President and Chief Executive Officer
Mike Sumner — Chief Medical Officer and RRP Program Lead
Steve Egge — Chief Commercial Officer
Peter D. Kies — Chief Financial Officer
Jay Olson — Analyst
Roy Buchanan — Analyst
Sudan Loganathan — Analyst
Liang Cheng — Jefferies — Analyst
Matthew Morrow — Vice President, Translational Sciences
Unknown Speaker — — Analyst
Anish Nikhanj — Analyst
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