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spk03: Good afternoon and welcome to the Inovio Pharmaceuticals fourth quarter 2021 financial results conference call. All participants will be in listen-only mode. Should you need assistance, please signal a conference specialist 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.
spk06: Thank you, operator. Good afternoon and thank you for joining the Inovio fourth quarter 2021 financial results conference call. Joining me on today's call are Dr. Joseph Kim, President and CEO, Mr. Peter Keyes, Chief Financial Officer, Dr. Jackie Shea, Chief Operating Officer, Dr. Lermont Hemo, Chief Scientific Officer, Mark Twyman, Chief Commercial Officer, Dr. Jeffrey Skolnick, Senior Vice President of Clinical Development, and Dr. Kate Broderick, Senior Vice President of Research and Development. For today's call, we will review our corporate and financial information for the fourth quarter and full year ended December 31st, 2021, as well as provide an update on our efforts across our DNA medicines platform. We will address the status of Inovio's COVID-19 efforts, as well as enrollment and dosing milestones achieved across our other infectious disease and HPV-associated programs. 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 Medicine, 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. 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.innovio.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. Joseph Kim.
spk04: Thank you, Ben, and good afternoon. I appreciate everyone taking the time to join us today. The impact of the highly transmissible Omicron variant of SARS-CoV-2 over the past few months highlights the enduring threat of COVID-19, particularly the unpredictability of current and future variants of concern. The ongoing impact of COVID-19 reaffirms and underscores the continued public health need and ongoing challenge to improve access to both primary vaccines and boosters across the global community. Assessment to this challenge is the fact that while over 63% of the global population has received at least one vaccine dose, and a growing number have received boosters, in certain countries, first dose vaccination rates are still below 12%. There is clearly more work to be done. Since the emergence of Omicron as the predominant COVID-19 variant circulating in the globe in November, the expectation for vaccination has changed. The highly infectious nature of Omicron has meant that while vaccines currently available in the market may not directly prevent infections, they can significantly protect the vaccinated from severe disease, hospitalization, and ultimately death. In this regard, many experts believe that virus targeting T cell responses are thought to play an important role in protection against severe disease and death, and may be central to the durability of vaccine protection. Inovio observed full maintenance of T cell responses against the Omicron variant in clinical samples from INO4800 vaccinated individuals. The preservation of T cell responses continues to remain a consistent observation for INO4800 against the ancestral COVID-19 virus and across all variants of concerns tested to date, including Omicron. In response to the dominance of Omicron variant globally, and the persistence of cross-reactive T cell responses generated by INO4800 across all VOCs to date, we plan to seek regulatory approval to amend the primary endpoint for our Phase III INOVAID trial from prevention of all symptomatic disease to prevention of severe disease. We believe INO4800's ability to generate T cell responses could be critical in meeting the proposed amended primary endpoint. In addition, due to the emergence of Omicron, the Data Safety Monitoring Board of our annual 4800 program recommended that we pause the enrollment of new participants to update the informed consent form and investigator brochure to reflect the potential impact of Omicron on the trial. The DSMB stated that safety issues were not a factor in this recommendation, and dosing may continue for those participants who have already received their first dose. As a result of the DSMB recommendation, as well as our plan to seek approval to amend the trial's primary endpoint, we have paused enrollment of new participants for Innovate. Interim efficacy data from Innovate will therefore not be available in the first half of 2022 as previously expected. In addition, we're also evaluating the feasibility of an additional XUS heterologous boost trial for IN04800 as a booster in a non-inferiority clinical trial compared to previously approved viral vector and inactivated COVID-19 vaccines. This will complement the ongoing booster trials that are being conducted in China by our partner at Vaccine. Viral vector and inactivated COVID-19 vaccines have been the most widely administered vaccine types globally, particularly in low to middle income countries, accounting for more than half of all doses delivered worldwide. Currently, approved and authorized vaccines may not meet the global demand for boosters to address the waning protection, a need which some regulatory agencies are considering with respect to evaluating a clinical pathway for heterologous boost candidates in clinical trials. In addition to early data from independent studies that suggest a mix and match booster strategy of heterologous boosting may confer advantages over the homologous boosting approach, IN04800's key advantages as a DNA vaccine correspond well with desired features of a heterologous boost vaccine. These advantages include its observed T-cell immunity for disease protection, tolerability for re-administration, favorable thermal stability profile for global transport, storage, and distribution, and ease of construct design, allowing for timely scaling and manufacturing. We are also pleased to share that a vaccine has completed enrollment of his 200 participant homologous and 267 participant heterologous boost phase 1 slash 2 clinical trials. The trials are designed to evaluate the safety, tolerability, and immunogenicity of INO4800 as a homologous boost, where INO4800 was administered as the primary vaccine, and as heterologous boosts where inactivated vaccines were administered as the primary vaccine. We look forward to sharing additional updates as a vaccine progresses with the trial. And as we shared last quarter, the World Health Organization, or WHO, selected INO4800 to be tested in a large international randomized control phase three clinical trial the solidarity trial vaccines, which is ongoing and being funded, sponsored, and conducted by the WHO. We are truly proud that INO4800 is the only DNA vaccine selected for this trial. We believe INOVO can most effectively support the global community as COVID-19 shifts from pandemic stage to endemic stage, while leveraging the strength of our DNA medicines platform and deep experience combating infectious diseases. With that, I'll turn it over to Dr. Kate Broderick, our Senior Vice President of R&D and Co-Program Lead for COVID Program, who will provide further details regarding INO4800 and the Omicron variant as well as our continued progress across our other infectious disease programs. Kate?
spk01: Thank you, Joseph, and hello, everyone. It's very nice to be with you today. Inovio's in vitro assessment of the cross-reactivity of INO4800 vaccine-induced immune responses against Omicron variant of SARS-CoV-2 demonstrated full maintenance of T cell responses. including the all-important CD8 killer T responses. However, as was seen with the vaccines of other developers, it also showed significantly decreased levels of both neutralizing and binding antibodies against the Omicron variant. The maintenance and the preservation of T cell responses remains a consistent observation for INO4800 against the ancestral COVID-19 virus. Omicron and all the other variants of concern tested to date. We, along with many in the scientific community, believe that T cell responses play an important role in protecting against severe disease and death and may be central to the durability of vaccine protection. As Joseph noted, we've also advanced our other infectious disease programs. Progress that we're particularly proud of given the continued global pandemic and the hard work of both our Inovio colleagues and our partners. I'm pleased to share that we have completed full enrollment of 192 participants for the dose finding stage of our phase two trial to value the safety, tolerability, and immunogenicity of our DNA vaccine candidate INO4700 against MERS. The randomized, double-blinded, placebo-controlled trial will enroll approximately 500 healthy adults in total. Sponsored by Inovio and fully funded by CEPI, the trial is being conducted at sites in Jordan, Lebanon, and Kenya. Inovio also completed full enrollment of our Phase 1b trial for INO4500, our DNA vaccine candidate for Lassa fever. Also funded by CEPI, This trial includes 220 participants and is ongoing at the Noguchi Memorial Institute for Medical Research in Accra, Ghana. Notably, it is the first vaccine clinical trial for Lassa fever conducted in West Africa, where the viral illness is endemic. There is currently no approved vaccine for Lassa fever, which impacts an estimated 300,000 people in the region annually. The WHO classifies this viral illness as one of the pathogens with epidemic potential, making the development of a safe and effective vaccine a global health priority. Finally, in another example of Inovio's experience leveraging our DNA medicines technology in a boosting capacity, we completed enrollment of 46 healthy participants as part of a randomized placebo-controlled Phase 1B clinical trial evaluating the safety, tolerability, and immunogenicity of INO4201, our DNA vaccine candidate for Ebola. The trial dosed its first participant in November and will assess whether INO4201 can be used as a booster in healthy participants previously vaccinated with our VBOL. With that, I'll turn it back to you, Joseph. Thank you. Thank you, Kate.
spk04: Our efforts in infectious diseases underscore the differentiating attributes of our DNA medicines platform. The tolerability of our DNA medicines and the ability to remain stable at room temperature for more than a year at 37 degrees Celsius for more than a month and have a five-year projected shelf life at normal refrigeration temperature without needing to be frozen ever during transport or storage allows us to support public health measures in tropical environments and all other areas where ultra-cold and cold storage may not be widely available. And now, Dr. Jeffrey Skolnik, our SVP of Clinical Development, will provide an update on our other important clinical programs. Jeffrey? Thank you very much, Joseph.
spk08: As it relates to our Novio HPV-associated disease programs, we completed enrollment in Reveal 2, our second global Phase III clinical trial of VGX3100 for cervical high-risk squamous intraepithelial lesions, or H-CIL. And we expect to have top-line efficacy and safety data available in the fourth quarter. We've also completed the 52-week safety follow-up of Reveal 1 participants, which showed that VGX3100 remained well-tolerated through week 88. Additionally, participants treated with VGX3100 who met the primary endpoint at week 36 remained clear of HPV16 and or HPV18 at week 88. We continue to progress our efforts on the co-development of a liquid biopsy-based diagnostic built on next-generation sequencing technology with Kyogen. This diagnostic may serve to guide clinical decision-making for the use of VGX3100 in cervical H-cell. And this biomarker is validated may have the potential to identify those women who are more likely to have a favorable treatment outcome with VGX3100, specifically the regression of cervical H-cell and clearance of HPV virus. We expect to have additional information on our biomarker development process later this year. Now to update on INO3107. our DNA immunotherapy candidate to treat HPV 6 and 11-associated recurrent respiratory papillomatosis. By year-end, Inovio had completed enrollment of 32 participants with HPV 6 and or HPV 11-associated RRP in our open-label multicenter Phase I-II clinical trial. RRP is a rare disease characterized by the growth of tumors in the respiratory tract caused by HPV, which can lead to life-threatening airway obstructions. RRP is incurable and often requires repeated surgeries due to its recurrence. INO 3107 received orphan drug designation from the FDA in July of 2020. And as you know, our Phase I-II trial is assessing safety, tolerability, immunogenicity, and efficacy of 3107. And we expect these preliminary efficacy data from a portion of participants in the second half of this year. Moving on next to Inovio's immuno-oncology efforts, Dr. David Reuben, a key opinion leader in brain tumors and our coordinating PI for our GBM001 trial, presented updated data from our Phase II trial for INO5401. our DNA medicine for patients with newly diagnosed glioblastoma, or GBM, at the CITSE pre-conference workshop last November. This trial showed that INO5401 combined with INO9012, simiplimab, and radiation and temozolomide chemotherapy have an acceptable safety profile, are immunogenic, and may improve survival in newly diagnosed GBM. Overall survival at 24 months was 22%, or 7 out of 32, in the MGMT promoter unmethylated cohort, and 55%, or 11 out of 20, for the MGMT promoter methylated cohort. We continue to follow participants in the trial, and we plan to provide additional updates in the future. And now, I'll turn the call back over to Joseph.
spk04: Thank you, Jeffrey, for clear updates. Before moving to our quarterly and full-year financials, I want to briefly discuss our non-binding Memorandum of Understanding signed in October with Columbia's Ministry of Health and Social Protection. This MOU creates a framework for collaboration by which Inovio and the Colombian government can explore knowledge sharing, technology licensing, and capacity building that supports developing and producing vaccines and other biopharmaceuticals in Colombia. The potential results of these efforts include developing local manufacturing capabilities across Innovio's DNA medicines platform, as well as related products and technologies. Now, I will turn the call over to Peter Keyes, our CFO, for our fourth quarter and year-end financial summary. Peter?
spk00: Thanks, Joseph, and good afternoon, everyone. We ended the fourth quarter with $401.3 million in cash, cash equivalents, and short-term investments, compared to $411.6 million as of December 31, 2020. As of December 31st, 2021, Inovio had 217.4 million common shares outstanding and 234 million common shares outstanding on a fully diluted basis. Total revenue was $839,000 and $1.8 million for the quarter and year ended December 31, 2021, respectively, compared to $5.6 million and $7.4 million for the same periods in 2020. Total operating expenses were $106.3 million and $303 million for the quarter and year ended December 31, 2021, compared to $34.9 million and $131.5 million for the same periods in 2020. The increase in total operating expenses in 2021 was primarily due to scale-up and production costs related to plasmid and device manufacturing related to INO4800. Our net loss for the quarter and year ended December 31st, 2021 was $106.9 million or 50 cents per share, basic and dilutive, and $303.7 million or $1.45 per share, basic and dilutive, compared to a net loss of $24.3 million, or $0.14 per share, basic and dilutive, and $166.4 million, or $1.07 per share, basic and dilutive, for the same period in 2020. Inovio's research and development expenses for the quarter and year-ended December 31, 2021, were $92.3 million and $249.2 million, compared to $26.3 million and $94.2 million for the same periods in 2020. The year-over-year increase in R&D expenses was primarily related to higher drug manufacturing, outside services and clinical trial expenses related to INO4800, expenses related to the acquisition and installation of manufacturing equipment related to INO4800, higher engineering services, expensed equipment and inventory related to our Selectra 3PSP device array automation project, and higher employee and contractor compensation, among other variances. General and administrative expenses were $14 million and $53.8 million, respectively, for the quarter ended and year ended December 31st, 2021, versus $8.6 million and $37.2 million, respectively, for the same periods in 2020. The year-over-year increase in G&A expenses was primarily related to increase in employee compensation including non-cash stock-based compensation due to an increase in employee headcount among other variances. As a reminder, you can find our full financial statements in this afternoon's press release, as well as in the company's Form 10-K filed with the SEC. And with that, I'll turn it back to you, Joseph.
spk04: Thank you, Peter. Before we take analyst questions, I want to express my true appreciation for the entire Innovio team, as well as our trial participants, collaborators, funders, and partners across all of our clinical programs. Without their contributions, we would not be able to advance our efforts to help address critical unmet global health needs. I am thankful for their continued support and proud of our collective efforts to date. In closing, we are committed to fulfilling the potential of our DNA medicines platform and are encouraged by our progress across our portfolio. This past quarter, we completed four enrollment in four trials across four indications. We believe in the advantages of DNA medicines and vaccines platform in combating infectious diseases, cancer, and HPV-associated diseases due to their ability to generate functional T cell and antibody responses, tolerability, and strong thermal stability profile. We look forward to sharing our continued progress as we advance these efforts. With that, let's open the call for questions. Operator?
spk03: 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 are using a speakerphone, please pick up your handset before pressing the keys. To withdraw your question, please press star then 2. At this time, we will pause momentarily to assemble our roster. And our first question will come from Jeff Meacham of Bank of America. Please go ahead.
spk02: Hi, this is Alex Hammond on for Jeff Meacham. Thank you for taking our question. So on VGX3100, will you utilize the biomarker data generated in combo with QIAGEN to bucket patients for the Phase 3 Reveal 2 trial? And have you discussed the path forward for submission with the FDA? Thank you.
spk04: Yeah, thank you, Alex, for VGX 3100 question. I will turn it over to our program lead, Jeffrey, Dr. Jeffrey Skolnick. Jeffrey?
spk08: Sure. Thanks, Joseph. And Alex, thanks for the question. So, you know, as we said during the call, Inovio and QIAGEN are continuing to advance the biomarker development essentially by identifying candidate biomarker signatures for VGX 3100. And to identify those signatures that ideally will be able to, as it were, prognosticate or predict those women that are most likely to respond to VGX3100. That's the vision for the biomarker, and we are very encouraged by our progress so far. The biomarker, if validated, may have the potential to identify those women. And we are continuing to move that opportunity forward. As you know, both Reveal 1 and Reveal 2 are studies that were designed with the potential for the biomarker in mind. And so we've always considered the biomarker to be an extremely important part of this program. To answer your second question, We are now looking to potentially engage with our regulatory colleagues to best understand the path forward for this biomarker. And as you know, Reveal 1 has shown us that we can, without the biomarker, show in the valuable population a statistically significant difference between VGX3100 women clearing and resolving cervical H cell secondary at 16, 18, and those treated with placebo. So we look forward very much to really understanding how best to utilize the biomarker and to have that conversation with our regulatory colleagues.
spk02: Thank you for the color.
spk04: Thank you.
spk03: The next question comes from Hartaj Singh of Oppenheimer. Please go ahead.
spk09: Hey, everybody. Thank you for the question and good and steady progress there. You know, on just your trial, the innovate trial, Joseph and team, you know, Santa Fe GSK reported a vaccine efficacy of 58%, right? So they ended their trial before Omicron really hit. They're looking for approval. Their severe disease endpoint looked pretty good. Moderna is already talking about, you know, bivalent vaccines, Omicron. It seems you're getting, you know, proactive in trying to get ahead of what Omicron can do to current vaccines in development or approvals. You know, how are you thinking if you were to get that protocol amendment, you know, would you essentially market the vaccine, you know, on that disease severity endpoint, hospitalization endpoint, plus the risk-benefit profile, the actual product profile of the vaccine? Is that how you're thinking about it, assuming you get the product profile and a success in phase three? And I just got a quick follow-up.
spk04: Yeah. Higher, Taj. Absolutely. That's the view that we have. Obviously, the Omicron has thrown a curveball to all vaccine developers with reduction in antibody responses from the original ancestral strain targeted vaccine, which, you know, all of the approved vaccines and some of the ones in testing, including INO4800, is. What's great about our Omicron data, as described by Kate and myself earlier, is that our T cell responses, including CD8 killer T cells, were fully maintained against Omicron. So that really leads us to believe that whether we're targeting the original variants, alpha, beta, gamma, delta, or even Omicron, or even what's next, right, the stealth Omicron or the next variant, we have full faith that our CD8 T cell responses and our overall T cell responses generated from INO4800 is going to persist and be maintained. So with that in mind, we are taking a proactive step, knowing that our probability of success in demonstrating prevention of severe disease with our vaccine against COVID-19 virus is high. And that's the label that we would look for and all of the other attributes and target profile that we have mentioned earlier. We believe our INO4800 has a strong position once we get the phase three data. and once we get the emergency and full licensure to demonstrate this benefits as a vaccine against SARS-CoV-2.
spk09: Yeah, great, great, Joe. I mean, your in vitro data, you know, matches up pretty well against, you know, some of the commercial and vaccines and approval. Just a quick question on WHO trial. Are they planning on doing any protocol amendments there, you know, to... Also, kind of, you know, for the Omicron or maybe future variants, just any updates there? And thanks for the question.
spk04: Yeah, you know, as a process, you know, WHO only speaks for WHO, so we're not privy to speaking for them. But what I can tell you is Omicron has equally impacted all vaccines being developed and trials in Europe. and currently undergoing. So, as you know, Solidarity Trial Vaccines is run and sponsored by the WHO and they have the full control and, you know, we have full confidence that they will be able to execute the trial as they see most appropriately. So, so far everything is moving as they had stated in the fall.
spk09: Great. Thank you, Joe.
spk04: Yeah. Thanks, Satosh.
spk03: Our next question comes from Gregory Renza of RBC Capital Markets. Please go ahead.
spk11: Hi. This is Ying-Wang for Greg. Thank you for taking our question. Maybe first, a question on 4800. I was just wondering if you could, you know, provide some more color on your expectations around the steps to seek regulatory approval to amend the primary endpoint and the timeline for that. And also, do you expect a change in trial size due to the change of primary endpoint? Thank you.
spk04: Yeah. Thanks for that great question. The steps to getting the primary endpoint amended is modifying and amending the protocol and getting them approved through various regulators who are overseeing the innovate trial in their respective countries. So we expect that to occur in the next year or so. you know, as expediently as possible across these regulatory bodies and their local ethics committees. We think we have a strong position in, because of our T cell maintenance against Omicron, as well as other variants of concern, I think we have a very strong case in that regard. In terms of the sizing, That is based on the severe case rates, including hospitalization, death, and such across various territories that Innovate is being tested. We don't expect to significantly change the sample size at this time, but of course, we are evaluating all of those real-time information that gets fed into our Innovate trial execution.
spk11: Great. Thank you. Appreciate that. And maybe another question on 3100. Just wondering when should we expect to learn more granularity on the timeline for Reveal 2 trial readout? And I just wanted to clarify if there were any design adjustments of the trial. Thank you.
spk04: Yeah. I'm going to take it, and if there's a follow-up question, I will let our expert, Dr. Skolnik, address it. But we fully enrolled about 200 participants in Reveal 2 in the fourth quarter. It's the last patient in 40 weeks of trial follow-up. So our projection is we would have preliminary results data, safety, immunogenicity, and efficacy in the fourth quarter of 2022. And no, we haven't had any changes to Reveal 2 protocol. It's identical to Reveal 1, except the safety follow-up is one month instead of one year.
spk11: Great. Thank you very much.
spk04: Yeah, thank you.
spk03: The next question comes from Steven Wiley of CIFL. Please go ahead.
spk05: Yeah, good afternoon. Thanks for taking the questions. Hi, Steve. Hey, how's it going, Joseph? Are you able to say how many patients were enrolled into Innovate at the time of the pause?
spk04: Yeah, no, we, it's our policy not to provide the, the up-to-date information. But we have a significant number of volunteers who have been dosed, and they will continue to receive the second dose and follow during the pause period. It's just the new enrollment that's paused. Okay.
spk05: And then maybe just to follow up on the last question, right? When you look across the phase three vaccine trials, I guess whether it's Novavax or Pfizer or Moderna, you know, the incidence rate of severe disease that is seen across those studies is anywhere between like one in 1,000 participants and one to four to 5,000 participants. So I guess in the context of having, you know, 7,000 to 8,000 patients study in a setting where omicron is presumably generating lower rates of severe disease i mean is there a chance that you see you know a low single digit number of severe events and i guess how do you how do you contemplate that from just the statistical power perspective when you think about you know not meaningfully changing the size of the study
spk04: Yeah, that's a great question. We're still powering our sample size to 90% power. So while it is true that the severity of Omicron infection has been reduced by, I believe, 50 to 75% of Delta, we believe the higher instances of infections will equalize out. But so your point about the severe disease incidences being a major driver of us getting the endpoint, I think that's a fair one. We are and we have evaluated those impacts and We expect the sample size to be around 7,000 to 10,000 as we had projected initially with our Innovate trial. And as I mentioned, we will be continually monitoring those severe disease rates across these territories. But I think we feel fairly good that we should be able to achieve our objectives going forward.
spk05: Okay. And then maybe just a question for Peter. You know, how should we think about just kind of where are the trends to near during the first half of the year? I know that there's some uncertainty, obviously, with innovate being paused, but should we anticipate a fairly significant step down in the pace of R&D spend in conjunction with the pausing?
spk00: No, we have ongoing efforts in a lot of areas going on with this, so I think you're going to see it remain fairly consistent with the other quarters, running in the 65 million burn range about per quarter.
spk05: Okay. Thank you for taking the questions.
spk04: Thank you, Steve.
spk03: The next question comes from Roger Song of Jefferies. Please go ahead.
spk07: Great. Thank you for taking our question. So one question is related to the booster. So Joseph, can you just comment what is the timing would look like for those Phase I-II data for the booster, heterologous or the homologous? And also, what will be the next step for the booster kind of a regimen?
spk04: Yeah, so thank you, Roger. The vaccine homologous and heterologous boost trials that's fully enrolled, they expect to have the data in the second quarter of this year. So it's, of course, being run and executed by our partner in China, a vaccine. So we expect the data from that trial sometime in the next quarter. In terms of additional heterologous boost, you know, we're deeply investigating the feasibility and executionability of a heterologous boost trial, again, outside the U.S., where we can compare with two of the most prolifically utilized primary vaccines for COVID, in viral vector and inactivated vaccines. So we're in the planning and feasibility stage. But if this is a go, we think we can execute this all through 2022. Got it.
spk07: That's very helpful. Thank you. And also, we know you have your own pan-coronavirus vaccine 4802, just any kind of an update regarding the progress?
spk04: Yeah, absolutely. Maybe I'll turn to Dr. Broderick to address that. Kate?
spk01: Yes, thanks very much. It's a great question. Really, you know, pan-COVID vaccines are very pertinent in the discussion at the moment, and that's something that the whole field is very interested in. We certainly are very excited about what our pan-coronavirus vaccine, INO4802, has shown pre-clinically, and we continue to develop it. But really what's particularly striking about our COVID vaccines across the board, including INO4800, is this pan-COVID T cell response that we're able to generate thus far. So even in the face of the wrench in the works that was Omicron, we're still maintaining those all-important T cell responses. So we're very excited and very encouraged about what our vaccines are able to generate.
spk07: Got it. Okay. Thanks for taking all the questions. Yeah. Thank you.
spk03: The next question comes from Yi Chen of HC Wainwright. Please go ahead.
spk10: Thank you for taking my question. My first question is, do you think it is possible that once you have the biomarker fully developed for the VJX3100, you will need to conduct an additional clinical trial using the biomarker?
spk04: Hi. That's a very good question for VJX3100. Again, I'll turn over to Dr. Skolnick with this question.
spk08: Yeah, thanks, Hugh. That's a great question. And, you know, as we mentioned before, remember that both Reveal 1 and Reveal 2 always anticipated examining, looking at this potentially predictive biomarker. So it has always been our intention to ask a biomarker question on both Reveal 1 and Reveal 2 And ultimately, those opportunities are, in truth, already in the protocols. So ultimately, to answer your question, clearly, we're going to explore all of the opportunities that we have with respect to these two studies with our regulatory colleagues. And certainly moving forward, we'll continue to have that conversation with them. But again, it's always been our intention to examine and potentially to utilize this biomarker.
spk10: Got it. And the next question is, with respect to 5401 in GBN, what is the next step and what are the expected catalysts for this program this year?
spk04: Well, we're continually following these patients, you know, Jeffrey Skolnick shared with you our OS24 beta, which is very encouraging compared to the standard of care in this very hard-to-treat cancer types in GBM. So we'll continue to follow them. We're evaluating our next steps with our collaborator, Regeneron. So, you know, I think the overall survival as well as the following of these surviving participants will give us additional insights into the path forward for this program.
spk10: Got it. And my last question is, when do you expect to report results from a Phase II trial of 4700? the MERS vaccine.
spk04: Yeah, so I'm going to turn that over to Kate. Kate?
spk01: I'm so sorry. Could you repeat the question for me? The line went bad for a minute.
spk10: When do you expect to report results from the Phase II trial of the MERS vaccine?
spk01: And yeah oh great question so we're currently still enrolling and at the moment we're about halfway through now so probably by Q3 of of this year.
spk10: Okay, thank you. Absolutely.
spk03: This concludes our question and answer session. I would like to turn the conference back over to Joseph Kim for any closing remarks.
spk04: Thank you very much for listening to our fourth quarter and full year 2021 conference call. We have an exciting year ahead of us in 22 with all of these programs, and we look forward to sharing them with you in the coming months. Thank you very much.
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