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spk23: Good afternoon and welcome to the Inovio Pharmaceuticals first quarter 2022 financial results conference call. All participants will be in a listen-only mode. Should you need assistance, please signal conference specialists by pressing the star key followed by zero. After today's presentation, there will be an opportunity to ask questions. To ask a question, you may press star then one on your telephone keypad. To withdraw your question, please press star then two. Please note this event is being recorded. I would now like to turn the conference over to Ben Mattone, Senior Director of Investor Relations. Please go ahead.
spk10: Thank you, Operator. Good afternoon, and thank you for joining the Inovio First Quarter 2022 Earnings Conference Call. Joining me on today's call are Dr. Jackie Shea, President and CEO, Mr. Peter Keyes, Chief Financial Officer, Dr. Laurent Hemot, Chief Scientific Officer, Mark Twyman, Chief Commercial Officer, Dr. David Leibowitz, Senior Vice President of Clinical Development for Infectious Diseases, and Dr. Jeffrey Skolnick, Senior Vice President of Clinical Development for Oncology and HPV Therapeutics.
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spk13: How are you doing with your recent work? Well, lately I've been collaborating with developers and engineers, and they work in entirely different ways than me, so I've really been learning a lot. That's right.
spk14: That's why I think the Killian's Game project is interesting. It's like we're all creating together with our knowledge and imagination.
spk01: When we were asked to shoot Killian's game, we were brought on to create an environment where new technologies could be used on set and there would be a direct dialogue to the technology side.
spk04: The engineers don't always have access to the actual creative process. So they're creating things in a vacuum, if you will. We have the Xperia capturing BTS, so they're able to see their technologies and their products getting used on set. It really is like a film school for engineers.
spk01: Our intention was to set up an air of mystery, leading the viewer to understand that we're driving towards a little bit of danger. The Airpeak was able to create that motion for us and follow the car at a speed that was exactly what we needed.
spk15: Something I learned through this project was that international collaboration is truly possible. We predominantly shot Killian's game here in LA, but the final shot of the film was captured in Japan in a virtual production stage
spk00: One of the things I enjoyed about creative prototyping is to kind of conquering the unknown errors that no one has ever solved before. I think if we do that, it's solving the problems for the future.
spk16: Working remotely definitely created certain sets of challenges. Getting the opportunity to film with the Venice 2 and then working within an amazing virtual wall over in Japan, that really changes the game for a lot of production. People from different places can work together and create really unique perspectives.
spk04: It was great to see Matt and Colin actually give active feedback on the feed to the second unit in Japan, and it was kind of like we were there almost.
spk15: We were able to tell a great story while testing technology, but at the root of it, the story is what will get people really excited and leave the audience wanting more.
spk13: It is so inspiring to see how much everyone grew from that experience, even though they are all working from different locations.
spk14: Absolutely.
spk10: For today's call, we will review our corporate and financial information for the quarter ended March 31st, 2022, as well as provide an update on our efforts across our DNA medicines platform. Following prepared remarks, we will conduct a question and answer segment reserved for equity research analysts. During the call, we will be making forward-looking statements regarding future events and the future performance of the company. These events relate to our business plans to develop Inovio's integrated platform DNA medicines, which include clinical and regulatory developments and timing of clinical data readouts, along with capital resources 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. 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 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. Jackie Shea.
spk02: Thank you, Ben, and good afternoon, everyone. Thank you to everyone joining the call today. I'd like to begin today's call by expressing my gratitude to the board for entrusting me to lead Inovio into its next chapter. While we have many challenges to face, I believe strongly in the potential of our DNA medicine technology and its ability to significantly and positively affect human health. We are committed to fulfilling the potential of our DNA medicines platform where we seek to make the greatest impact on health globally. This has served as the foundation for all our efforts to date and it continues to guide and underpin our work going forward. I would also like to thank Dr. Joseph Kim for his many contributions to Inovio as its co-founder. Joseph is a true entrepreneur and has been a pioneer in the field of immunotherapists and vaccines. Now, turning to today's financial and program update, let's begin with our COVID-19 vaccine. As the COVID-19 pandemic evolves towards the endemic phase, the need for booster vaccines to protect against severe illness and death represents a growing and strategic opportunity. In light of this, We now believe that an OVO can have the greatest impact and serve the most pressing public health needs by focusing our COVID vaccine on our heterologous booster strategy. And this is where a different vaccine is used to boost a primary vaccination. Towards that goal, we are advancing our efforts to evaluate INO4800 as a booster in non-inferiority clinical trials compared to currently authorized COVID-19 vaccines. Anovio is continuing discussions with regulators in select countries regarding potential regulatory pathways for licensure. Importantly, these efforts are in addition to the heterologous boost trial conducted by our partner, Advaxine, the preliminary data for which we will review in a moment.
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spk02: As we shift to prioritize our heterologous-boost strategy, we will discontinue our global phase three INOVAIT trial. This decision reflects emerging global data that indicate a lower incidence of severe COVID-19 cases caused by the Omicron variant and its sublineages, which would necessitate a subsequent increase in trial size and costs for INOVAIT to obtain an efficacy readout against severe disease. We believe this shift places Anovia's COVID-19 vaccine in a stronger strategic position to contribute to public health initiatives for COVID-19 going forward. It also allows us more flexibility in continuing to develop our DNA medicines platform. We will also provide an update today about a recent meeting that we had with the FDA regarding BGX3100, our HPV vaccine against HPV 16 and 18 associated cervical high-grade squamous intraepithelial lesions, or H-CIL. As you know, we are close to completing the Reveal 2, Phase 3 study with this therapy and have been evaluating the use of a biomarker to identify those women who will be most likely to benefit from VGX3100. The FDA has indicated that we will need at least one if not two, additional trials to obtain a marketing authorization for the product candidate. My colleague, Jeffrey Skolnik, will be describing this development in more detail later in our call today. But first, I'm pleased to introduce Dr. David Lieberwitz, an OVO's SVP of Clinical Development of Infectious Diseases and our COVID-19 clinical lead, to provide additional commentary on our COVID-19 program.
spk09: Thank you very much, Jackie. And greetings, everyone. We believe the increased global awareness about the significance of vaccine-induced T cell responses and durability of protection for effective booster vaccines works to the advantage of one of INO4800's key strengths, its ability to generate CD8-positive T cell responses. We are pleased to share encouraging preliminary data from our partner, Advaxine's 267 participant heterologous boost trial, which we believe supports our decision to pursue the heterologous boost pathway. Advaxine's heterologous boost clinical trial assessment of immune responses from a two-dose primary series of an inactivated COVID-19 vaccine followed by a boost with INO4800 after three or six months. Interim immunogenicity data showed that using INO4800 as a booster after six months resulted in a 6.3-fold increase in T cell immune response. In a separate ad vaccine study where three doses of an inactivated COVID-19 vaccine were assessed, the cellular response increased by 1.7 fold. Further, the highest booster effect of INO4800 was observed with a 2 milligram dose of INO4800 delivered six months after a primary series with an inactivated vaccine. Following INO4800 vaccination, the preservation of cross-reactive T cell responses remains a consistent observation against multiple SARS coronavirus 2 variants of concern, including Omicron, without a significant loss in the response magnitude. T cells that can recognize SARS coronavirus 2 may play a role in reducing disease severity. Therefore, INO4800 has the potential to play an important role in reducing incidence of severe COVID-19 cases which could reduce hospitalizations as the virus continues to mutate and new variants arise. This heterologous boost study further supports the advantages of our DNA medicines platform, including our ability to elicit T cell responses, potential for readministration, temperature stability, and favorable safety profile. Building on our productive collaboration for the clinical development of INO4800 over the past year and a half, we're planning to expand our partnership with Advaxine with an expanded focus on heterologous boosting and new constructs covering future variants. This arrangement will enable Inovio and Advaxine to leverage Advaxine's multiple manufacturing sites in China and access opportunities globally. I'll now turn the call over to Inovio's SVP of Clinical Development, Dr. Jeffrey Skolnick, for an update on our HPV and oncology programs. Jeffrey?
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spk05: Thank you, Dave. We'll now talk about Inouyeo's HPV-associated disease programs. We recently met with representatives from the U.S. FDA regarding our late-stage clinical trials for VGX3100 against HPV16 and 18-associated cervical high-grade squamous intraepithelial lesions, or H-CIL. During this meeting, the FDA advised us that our regulatory strategy to use Reveal-2 which is the second of two Phase III trials for VGX3100, to evaluate efficacy in biomarker-selected population would not provide sufficient evidence to support approval of a potential marketing application for VGX3100 in that biomarker population. The FDA recommended that using REVEAL-2 as an exploratory study to evaluate a biomarker-selected population and then to conduct one or two additional prospective well-controlled trials in the biomarker-selected population to be more likely to provide sufficient evidence to support approval of a marketing application. To better assess potential efficacy in that biomarker-selected population, we plan to amend the fully enrolled Reveal-2 to revise the primary analysis population from the all-comers to the biomarker-positive population. Both the biomarker-positive population and the all-commerce population will be analyzed with respect to efficacy. We will continue our Reveal 2 trial to completion and will assess the path forward for the VGX3100 program following analysis of the Reveal 2 results. Given the likelihood of at least one additional trial, we no longer expect to submit a BLA in 2023 for VGX3100. We maintain full conviction in our DNA medicines and in our development programs in HPV diseases, given our prior evidence of our DNA medicines platform, specifically VGX3100, to both regress lesions caused by HPV16 and 18 and to clear HPV16-18 virus from those lesions. With respect to INO3107, our DNA immunotherapy candidate to treat recurrent respiratory papillomatosis, or RRP, a rare and orphan disease, we've completed enrollment in our open-label, multi-center, phase 1-2 clinical trial of 32 participants with HPV 6 or 11 associated RRP. This yet incurable disease is characterized by the growth of small tumors, or papillomas, in the respiratory tract caused by HPV and can lead to life-threatening airway obstructions. These papillomas often recur, requiring repeat interventions. Our trial includes adults with HPV 6 or 11 RRP who have required at least two interventions in the past year to remove disease. Trial participants will first undergo removal of their papillomas and will then receive up to four doses of INO3107 once every three weeks. The efficacy endpoint will be a reduction in the frequency of cervical interventions following the first dose of INO3107 relative to the frequency prior to clinical study therapy. We expect preliminary efficacy, safety, and immunogenicity data from a portion of trial participants in the second half of this year. for clinical development. Regarding Inovio's immuno-oncology programs, we are very excited that our novel trial of DNA medicines INO5401 and INO9012 in combination with Regeneron's PD-1 inhibitor Libtyo, the treatment of newly diagnosed glioblastoma, or GBM, was selected for an oral presentation at next month's ASCO annual meeting. The full text of the abstract providing overall survival, safety, and immunogenicity data will be available on the ASCO meeting website beginning May 26th. And now I'd like to turn the call over to Peter Keeves, our Chief Financial Officer, for our first quarter financial summary. Peter?
spk11: Thank you, Jeffrey, and good afternoon, everyone. We finished the first quarter with $360.4 million in cash, cash equivalents, and short-term investments, compared to $401.3 million as of December 31, 2021. As of March 31, 2022, Anobio had $226.5 million common shares outstanding and $247.8 million common shares outstanding on a fully diluted basis. Total revenue was 199,000 for the first three months ended March 31st, 2022, compared to 371,000 for the same period in 2021. Total operating expenses were 71.9 million for the first quarter in 2022, versus 52.9 million for the first quarter in 2021. Our net loss for the quarter was 79.1 million or 36 cents per share basic and dilutive. That compares to a net loss of 54.4 million or 27 cents per share basic and dilutive for the same period in 2021.
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spk11: Anovio's research and development expenses were $56 million for the first three months of this year, compared to $39 million for the same period in 2021. The year-over-year increase in R&D expenses was primarily related to to a higher drug manufacturing and clinical trial expenses related to INO4800 and higher employee compensation. This increase reflects a $6.3 million contra R&D expense recorded from grant agreements. These increases were offset by lower engineering services and expense equipment related to our Selectra 3PSP device array automation project. among other variances. General and administrative expenses were $16 million for the quarter, compared to $13.9 million for the same period in 2021. The year-over-year increase in G&A expenses was mainly related to an increase in employee compensation and insurance expenses, among other variances. As a reminder, you can find our financial statements in this afternoon's press release as well as in the company's Form 10Q filed with the SEC. And with that, I'll turn it back over to Jackie. Thank you.
spk02: Thank you, Peter. Going forward, our commitment is to efficiently allocate our resources to our key programs in our pipeline to put Inovio in the best position to benefit patients, global health, and our stakeholders. For COVID-19, we are prioritizing our resources on a heterologous booster vaccine strategy, where our DNA vaccine platform, we believe, has advantages that can really make a difference. For HPV, we are committed to delivering immunotherapists to address HPV diseases with an alternative to surgery by focusing on the biomarker positive population in Reveal 2. Beyond the programs we've discussed on this call, We're also very excited about the upcoming milestones and data we have coming out later this year in our vaccines pipeline, including INO 45,000 for Lassa fever, INO 4700 for MERS, and INO 4201 as a booster against Ebola. We look forward to providing you with further updates on our pipeline in the coming months as our efforts progress. With that, let's open the call for questions.
spk23: Operator? We will now begin the question and answer session. To ask a question, you may press star then 1 on your telephone keypad. If you're using a speakerphone, please pick up your handset before pressing the keys. To withdraw your question, please press star then 2. The first question comes from Jeff Meacham of Bank of America. Please go ahead.
spk07: Good afternoon. This is Hao calling in for Jeff Meacham. Thanks for taking my question. So my first one is about the BGX3100. Given the change of primary endpoint, how is the trial powered given that change? And if you have already any color about how many patients are actually the biomark select population versus overall population. And then just second one is, you know, CEO transition. Could you provide any additional color about maybe the plan for CEO transition? Thank you.
spk02: Thank you very much for the questions. I think for the first question, I'll hand over to my colleague, Jeffrey Skolnick, who wants that one, and then I'll take the question about the CEO transition. Jeffrey?
spk05: Thank you, Jackie. Thanks, Hal, for the question. So with respect to your first question regarding the power of the biomarker, again, our focus is really on identifying the population in whom VGX3100 has the greatest potential to demonstrate efficacy. And as we've shared previously, we continue to move forward with the development of that biomarker. As it relates to the population within the study, while we haven't yet shared the percentage of patients that would be biomarker positive, what we can say is that we fully anticipate that the study is appropriately powered given the efficacy that we expect to see in the biomarker positive population. Again, that's specifically why we're really interrogating that particular question in the biomarker positive population for VGX3100 for cervical disease. So the short answer is yes, the study is powered appropriately.
spk06: Jackie?
spk02: Thank you, Jeffrey. So with regards to the CEO transition, first of all, I'd like to say that I'm really honored to be entrusted by the board to lead Inovio into its next chapter. And I would also like to thank Dr. Joseph Kim, our co-founder, for his many contributions to Inovio over the years to date. Organizations grow and evolve continually. Here at Inovio, we remain focused on the road ahead as we seek to improve the lives of patients globally and support global public health. Our talented and dedicated team continue to advance our efforts forward. Thank you.
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spk21: Thank you very much.
spk22: The next question comes from Hartaj Singh from Oppenheimer. Please go ahead.
spk06: Great. Thank you for a couple of questions. Just want to say my regards to Joseph in my interaction with him. I think he always tried his best. Sometimes things don't work out, but really wishing him the best and the team. And Jack, congratulations to you. You know, one quick question I would just have is, what is, you know, for the possible for the head of August booster market, you know, that market is sort of broadening and deepening as more people get their vaccine. What would be a potential pathway forward? I mean, would you just need to run a booster trial and that would be it? Would you need a safety database? How long would you have to run it? Just any color there, and then I just got a couple of quick follow-ups.
spk02: Sure, Hartog, and it's very nice to talk with you. So with regards to the questions around the heterologous booster pathway, this is a regulatory pathway that's been evolving rapidly over the past few months, and OVO is in discussion with a number of regulatory authorities about the path forward. So I'll pass it over to Dave to see if he can add any further color there. But I would say this is an evolving landscape at the moment, and things are moving quickly. Dave?
spk09: Yeah, thank you, Jackie, and thank you for your question. Yeah, as Jackie said, we are continuing discussions with regulators in our target countries on regulatory pathways for licensure. We obviously can't comment on behalf of the regulators But we are seeing more and more arguments for heterologous boosting. We do understand that we will need a safety database. And as part of those discussions with the regulators, we're determining the size of that database that will be required.
spk06: Great. Thank you for the answers. Just two quick questions. What's the status of your manufacturing relations with Thermo Fisher? I believe that they had dedicated or were thinking about dedicating an entire facility in California to manufacturing of DNA Cosmets. And then secondly, if you can just kind of give us an indication, what are the parameters for the burn? How far could you go out with some of the projects you're undertaking, some of the projects you're shifting around? And thanks for the question.
spk02: Okay, thank you. So I'll take the Thermo Fisher question, and then Peter maybe could handle the runway question. So with regard to Thermo Fisher, so Thermo Fisher are a key partner for us in our manufacturing consortium, and we continue to work very closely with them to scale up our manufacturing processes. And they're going to remain key to our plans going forward. Peter, do you want to talk about the cash transition?
spk11: Yes, thanks. Hi, Hercoges. This is Peter. So, you know, Hercoges, we do anticipate definitely a reduction in our monthly burn. Right now we're evaluating the impact of just continuing to innovate, and we're also reprioritizing our resources across our pipeline programs. So we will provide updates when we have more information to disclose. And that should be a little bit later this summer.
spk06: Yep, understood, Peter. Thank you, Jacqueline. Thank you, Peter. Thank you.
spk11: Thank you.
spk23: Thank you. As a reminder, if you have a question, please press star 1. The next question comes from Roger Song from Jefferies. Please go ahead.
spk08: Great. Thank you for taking the question. Maybe just as a follow-up for the Heather Logers COVID program. Since you have pretty good this kind of cellular response after the inactivated vaccine as a booster, just curious, do you have any humoral data, response data there? And I think, you know, so I understand you're having discussion with the different regulators, but is that possible this cellular response will be the primary endpoint for the heterologous study or like other studies? vaccine so far, they need to be approved based on the humoral response data. Thank you.
spk02: Okay, thank you. So with regards to the heterologous boost strategy, I think I'm going to ask Dave to comment here on the endpoints. But what I would say is, you know, we see a real advantage of our DNA medicines program and our DNA platform generally in the heterologous boost space. We think we are generating, you know, really unique T cell responses, which can be incredibly useful. With regard to the antibody data from the ad vaccine studies, we hope to make that available later on over the summer, and we'll be publishing that data. And I'll pass it over to Dave to comment on the endpoint piece.
spk09: Thank you, Jackie. And thank you for the question. Yes, so it's a very good question. We do know that the scientific community is becoming increasingly aware of the critical role that T cells play in the prevention of severe COVID. And over time, we believe that this will be a key consideration in regulatory decision-making. But you are correct. Right now, the pathway forward for heterologous boosts appears to be non-inferiority of the humoral immune response. And as I said, we're in discussions with regulators, which will include a discussion around endpoints.
spk21: Got it. Yeah.
spk08: So thanks for the comment. And then just a very quick one for 5401, the DDM program. What will be the next step for this program and when will we can see some additional clinical data on that program? Thank you.
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spk02: Thank you, Roger. So I'm going to hand that question over to my colleague, Jeffrey. I would just say we're very excited to be having that presentation at ASCO. So I think that'll be the next opportunity to talk about that data for Jeffrey.
spk05: Yeah, thanks, Roger, for the question. Thank you, Jackie. I would just echo what Jackie's just shared, which is that certainly we're extremely pleased to have the opportunity to present an oral presentation this year at ASCO regarding the newly diagnosed GBM data. And, you know, essentially following that presentation, we are going to continue to take a look at the totality of the GBM space and 5401 and really think about what our next step should be within the GBM landscape. So I would say just stay tuned.
spk21: All right. Great. Thanks. That's it for now. Thank you. Thank you, Roger.
spk23: The next question comes from Yi Chen from H.C. Wainwright. Please go.
spk03: Thank you for taking my questions. First question is, could you please give us more insights on the basis, I mean the reason, the basis based on which the FDA provided their recent opinion regarding the review to trial? Was it the review one data or was there something else?
spk02: Thank you, Lee. That's a great question. So this really came from an interaction with the FDA, an interaction that we requested. So Jeffrey, can you provide some further context?
spk05: Sure. So thank you for the question. Certainly with respect to the opportunity to speak with FDA, as Jackie just suggested, this was a meeting that we essentially wanted to hold with FDA specifically, again, as we talked about before, to really find a pathway forward for BGX3100 in those women with cervical dysplasia for whom BGX3100 had the greatest potential for efficacy. And so in terms of the path forward, while, again, we certainly would not speak for regulatory agencies what they shared with us was essentially consistent with the pathway forward in a biomarker-selected population. So, you know, ultimately, what we're really aiming to do is to identify that population in women for whom 3100 is most likely to be efficacious, and that's really where our conversations with FDA have centered.
spk03: And could you tell us what are the countries in which you're going to pursue the COVID heterologous booster strategy?
spk02: So what I can say here is that we're currently in discussions with regulators in a number of countries, and we hope to be making announcements about which countries will be pursuing our heterologous boost approaches. in the coming months. But I think it's a little early to comment on that yet. Thank you.
spk03: Got it. And my last question is, will Inovio consider adding additional candidates into the pipeline?
spk02: That's a great question. So we are really competent in our DNA medicine technology. We can do a lot of different things. We can We have a strong pipeline in HPV. We have our IO candidates and we have our ID vaccine candidates. We also have some early stage products in DMAPs and by specifics. However, I think what's really important to us is moving our key programs forward and really focusing our efforts and resources on moving those programs forward. We have a number of key data points coming up over the coming year and early into next year. And we're going to really be looking at the data and focusing on what we think is the best path forward and the best way to bring our DNA medicines to the patients who need them. So I would say it's a question of looking at the data and really focusing on the best opportunities for patients and for our stakeholders.
spk21: Thank you.
spk23: This concludes our question and answer session. I would like to turn the conference back over to Dr. Jackie Shea, President and CEO, for closing remarks. Thank you very much.
spk02: And thank you all for the questions and to those who joined us today. As I stated, Inovio remains focused on DNA medicines technology and our innovative pipeline to save lives and improve global health. We have several catalysts later this year and early next year with important data readouts for Rubio 2, RRP, MERS, Lassa, and Ebola. I look forward to updating you on our program development and speaking with you again on the company's next earnings call in August.
spk22: Have a good evening, everyone. Goodbye. The conference is now concluded. Thank you for attending today's presentation. You may now disconnect.
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