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 Matone, Senior Director of Investor Relations. Please go ahead.
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 Kies, Chief Financial Officer, Dr. Jackie Shea, Chief Operating Officer, Dr. Laurent Humeau, Chief Scientific Officer, Mark Twyman, Chief Commercial Officer, Dr. Jeffrey Skolnik, 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 plan 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 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.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. Joseph Kim.
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, an ongoing challenge to improve access to both primary vaccines and boosters across the global community. Testament 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 INO-4800 vaccinated individuals. The preservation of T-cell responses continues to remain a consistent observation for INO-4800 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 INO-4800 across all VOCs to date, we plan to seek regulatory approval to amend the primary endpoint for our phase III INNOVATE trial from prevention of all symptomatic disease to prevention of severe disease. We believe INO-4800'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 INO-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 its 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 ex-U.S. heterologous boost trial for INO-4800 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 Advaccine. 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 their 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, INO-4800'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 its 200-participant homologous and 267-participant heterologous boost phase I/II clinical trials.
The trials are designed to evaluate the safety, tolerability, and immunogenicity of INO-4800 as a homologous boost, where INO-4800 was administered as the primary vaccine and as heterologous boost, where inactivated vaccines were administered as the primary vaccine. We look forward to sharing additional updates as the vaccine progresses with the trial. As we shared last quarter, the World Health Organization, or WHO, selected INO-4800 to be tested in a large international randomized control phase III clinical trial, the Solidarity Trial Vaccines, which is ongoing and being funded, sponsored, and conducted by the WHO. We are truly proud that INO-4800 is the only DNA vaccine selected for this trial. We believe INOVIO 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 INO-4800 and the Omicron variant, as well as our continued progress across our other infectious disease programs. Kate?
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 INO-4800 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 INO-4800 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 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 II trial to evaluate the safety, tolerability, and immunogenicity of our DNA vaccine candidate, INO-4700, 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 I-B trial for INO-4500, 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 I-B clinical trial evaluating the safety, tolerability, and immunogenicity of INO-4201, our DNA vaccine candidate for Ebola. The trial dosed its first participant in November and will assess whether INO-4201 can be used as a booster in healthy participants previously vaccinated with the rVSV-ZEBOV.
With that, I'll turn it back to you, Joseph. Thank you.
Thank you, Kate. 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. 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. As it relates to our INOVIO HPV-Associated Disease Programs, we completed enrollment in REVEAL 2, our second global phase III clinical trial of VGX-3100 for cervical high-risk squamous intraepithelial lesions, or HSIL. 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 VGX-3100 remained well-tolerated through week 88. Additionally, participants treated with VGX-3100 who met the primary endpoint at week 36 remained clear of HPV-16 and/or HPV-18 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 QIAGEN. This diagnostic may serve to guide clinical decision-making for the use of VGX-3100 in cervical HSIL.
This biomarker, if validated, may have the potential to identify those women who are more likely to have a favorable treatment outcome with VGX-3100, specifically the regression of cervical HSIL and clearance of HPV virus. We expect to have additional information on our biomarker development process later this year. Now to update on INO-3107, 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 obstruction. 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.
As you know, our phase I/II trial is assessing safety, tolerability, immunogenicity, and efficacy of INO-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 Reardon, a key opinion leader in brain tumors and our coordinating PI for our GBM-001 trial, presented updated data from our phase II trial for INO-5401, our DNA medicine for patients with newly diagnosed glioblastoma, or GBM, at the SITC Pre-Conference Workshop last November. This trial showed that INO-5401, combined with INO-9012, cemiplimab, 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 seven 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. Now I'll turn the call back over to Joseph.
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 Colombia'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 INOVIO 's DNA medicines platform, as well as related products and technologies. Now, I will turn the call over to Peter Kies, our CFO, for our fourth quarter and year-end financial summary. Peter?
Thanks, Joseph, and good afternoon, everyone. We ended the fourth quarter with $401.3 million in cash equivalents, and short-term investments, compared to $411.6 million as of December 31st, 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 thousand and $1.8 million for the quarter and year ended December 31st, 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 31st, 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 scaleup and production costs related to plasmid and device manufacturing related to INO-4800.
Our net loss for the quarter and year ended December 31st, 2021 was $106.9 million or $0.50 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 31st, 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 INO-4800, expenses related to the acquisition and installation of manufacturing equipment related to INO-4800, higher engineering services, expensed equipment and inventory related to our CELLECTRA 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. With that, I'll turn it back to you, Joseph.
Thank you, Peter. Before we take analyst questions, I want to express my true appreciation for the entire INOVIO 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 full 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?
We will now begin the question- and- answer session. To ask a question, you may press star then one 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 . At this time, we will pause momentarily to assemble our roster. Our first question will come from Geoff Meacham of Bank of America. Please go ahead.
Hi, this is Alex on for Geoff Meacham. Thank you for taking our question. On VGX-3100, will you utilize the biomarker data generated in combo with QIAGEN to bucket patients for the phase III REVEAL 2 trial? And have you discussed the path forward for submission with the FDA? Thank you.
Yeah. Thank you, Alex, for VGX-3100 question. I will turn it over to our program lead, Dr. Jeffrey Skolnik. Jeffrey?
Sure. Thanks, Joseph and Alex. Thanks for the question. 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. 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 VGX-3100. 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. 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. As you know, REVEAL 1 has shown us that we can, without the biomarker, show in the evaluable population a statistically significant difference between VGX-3100 women clearing and resolving cervical HSIL secondary to 16, 18 in those treated with placebo. We look forward very much to really understanding how best to utilize the biomarker and to have that conversation with our regulatory colleagues.
Thank you for the color.
Yep, thank you.
The next question comes from Hartaj Singh of Oppenheimer. Please go ahead.
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, Sanofi and GSK reported a vaccine efficacy of 58%, right? They ended their trial before Omicron really hit.
They're looking for approval. Their severe disease endpoint looked pretty good. Moderna's already talking about, you know, bivalent vaccine against 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 successful phase III? I just got a quick follow-up.
Yeah. Hi, Hartaj. 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 INO-4800, 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. 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 INO-4800 is gonna persist and be maintained. 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. That's the label that we would look for and all of the other attributes and target profile that we had mentioned earlier. We believe our INO-4800 has a strong position once we get the phase III data and once we get the emergency and full licensure to demonstrate this benefits as a vaccine against SARS-CoV-2.
Yeah. Great. Great, Joe. I mean, your in vitro data, you know, matches up pretty well against, you know, some of the commercial and approved vaccines. Just 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? Thanks for the question.
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 currently undergoing. 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 far everything is moving as they had stated in the fall.
Great. Thank you, Joe.
Yeah. Thanks, Hartaj.
The next question comes from Gregory Renza of RBC Capital Markets. Please go ahead.
Hi, this is Ying Wang for Greg. Thank you for taking our question. Maybe first a question on INO-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. Also, do you expect a change in trial size due to the change of primary endpoint? Thank you.
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. We expect that to occur in the next, you know, as expediently as possible across these regulatory bodies and their local ethics committees. We think we have a strong position 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, you know, 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. Of course, we are evaluating all of those real-time information that is fed into our INNOVATE trial execution.
Great. Thank you. Appreciate that. Maybe another question on VGX-3100.
Yeah.
Just wondering, when should we expect to learn more granularity on the timeline for REVEAL 2 trial readout? Just wanted to clarify if there were any design adjustments of the trial. Thank you.
Yeah. I'm gonna take it, and if there's a follow-up question, I will let our expert, Dr. Skolnik address it. 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. Our projection is we would have preliminary data, safety, immunogenicity, and efficacy in the fourth quarter of 2022. 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.
Great. Thank you very much.
Yeah, thank you.
The next question comes from Stephen Willey of Stifel. Please go ahead.
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 INOVATE at the time of the pause?
Yeah, no. It's our policy not to provide 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. Maybe just to follow up on the last question, right? When you look across the phase III vaccine trials, I guess whether it's Novavax or Pfizer, 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 4,000- 5,000 participants. I guess in the context of having, you know, 7,000- 8,000-patient 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? 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?
Yeah, that's a great question. We're still powering our sample size to 90% power. While it is true that the severity of Omicron infection has been reduced by, I believe, 50%-75% of Delta, we believe the higher instances of infections will equalize out. Your point about the severe disease incidences being a major driver of us hitting the endpoint, I think that's a fair one. We have evaluated those impacts, and we expect the sample size to be around 7,000-10,000, as we had projected initially with our INNOVATE trial. As I mentioned, we will be continually monitoring those severe disease rates across these territories.
I think we feel fairly good that we should be able to achieve our objectives going forward.
Okay. Then maybe just a question for Peter. You know, how should we think about just kind of where OpEx trends through the year 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 pause? And if there's any.
No. We have ongoing efforts in a lot of areas going on with this, so I think you're gonna see it remain fairly consistent with the other quarters, running in the $65 million burn range about per quarter.
Okay. Thank you for taking the questions.
Yep.
Yeah. Thank you, Steve.
The next question comes from Roger Song of Jefferies. Please go ahead.
Great. Thank you for taking our question. One question is related to the booster. Joseph, can you just comment, what is the timing will 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, regimen?
Yeah. 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. It's of course being run and executed by our partner in China, Advaccine. 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 execution ability of a heterologous boost trial again outside the U.S., where we can compare with two of the most prolifically utilized primary vaccine for COVID in viral vector and inactivated vaccine. We're in the planning and feasibility stage.
If this is a go, we think we can execute this all through 2022.
Got it. That's very helpful. Thank you.
Yeah.
We know you have your own pan-coronavirus vaccine, INO-4802. Just any kind of a update regarding the progress?
Yeah, absolutely. Maybe I'll turn to Dr. Broderick to address that. Kate?
Yes. Thanks very much. A great question. Really, you know, pan-COVID vaccines are very pertinent in the discussion at the moment, and that's something that, you know, the whole field is very interested in. We certainly are very excited about what, our pan-coronavirus vaccine, INO-4802, has shown pre-clinically, and we continue to develop it. Really what's particularly striking about our COVID vaccines across the board, including, INO-4800, is this pan-COVID T-cell response that we're able to generate thus far. Even in the face of the, you know, the wrench in the works that was Omicron, we're still maintaining those all-important T-cell responses. We're very excited and very encouraged about what our vaccines are able to generate.
Got it. Okay. Thanks for taking our questions.
Yeah, thank you.
The next question comes from Yi Chen of H.C. Wainwright. Please go ahead.
Oh, 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 VGX-3100, you will need to conduct an additional clinical trial using the biomarker?
Hi, Yi. That's a very good question for VGX-3100. Again, I'll turn over to Dr. Skolnik with this question.
Yeah. Thanks, Yi. It's a great question. You know, as we mentioned before, remember that both REVEAL 1 and REVEAL 2 always anticipated examining, looking at this potentially predictive biomarker. 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. Ultimately, to answer your question clearly, we're gonna explore all of the opportunities that we have with respect to these two studies with our regulatory colleagues. Certainly moving forward, you know, we'll continue to have that conversation with them. Again, it's always been our intention to examine and potentially to utilize this biomarker.
Got it. My next question is, with respect to INO-5401 in GBM, what is the next step and what are the expected catalysts for this program this year?
Well, we're continually following.
Thanks.
We're continually following these patients. You know, Jeffrey Skolnik shared with you our OS24 data, which is very encouraging compared to the standard of care in this very hard to treat cancer types in GBM. We'll continue to follow them. We're evaluating our next steps with our collaborator, Regeneron. 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.
Got it. My last question is, when do you expect to report results from the phase II trial of INO-4700, the MERS vaccine?
Yeah. I'm gonna turn that over to Kate. Kate?
I'm so sorry. Could you repeat the question for me? The line went bad for a minute.
When do you expect to report results from the phase II trial of the MERS vaccine?
Yeah. Oh, great question. We're currently still enrolling. At the moment, we're about halfway through now, so probably by Q3 of this year.
Okay. Thank you.
You're welcome.
Yeah, absolutely.
This concludes our question and answer session. I would like to turn the conference back over to Joseph Kim for any closing remarks.
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 2022 with all of these programs, and we look forward to sharing them with you in the coming months. Thank you very much.
The conference is now concluded. Thank you for attending today's presentation, and you may now disconnect.