Good afternoon and welcome to the Inovio Pharmaceuticals Fourth Quarter 2021 Financial Results Conference Call. All participants will be in listen-only mode. [Operator Instructions] After today’s presentation, there will be an opportunity to ask questions. [Operator Instructions] 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 31, 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 medicines, 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 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 healthy need and ongoing challenge to improve access to both, primary vaccines and boosters across the global community. Testament meant 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…

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 responses. However, as was seen with the vaccines of other developers, they also showed significantly decreased levels of both neutralizing and binding antibodies against the Omicron variants. The maintenance and the preservation of T cell responses remain 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 from 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 2 trial to evaluate 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 1b 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 new 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, another example of Inovio’s experience leveraging our DNA medicines technology and 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 INO-4201, our DNA vaccine candidate for Ebola. The trial dosed its first participant its first participant in November and will assess whether INO-4201 can be used as a booster in healthy participants previously vaccinated with our Ervebo. With that, I’ll turn it back to you, Joseph. Thank you.

Thank you, Kate. Our efforts in infectious diseases underscored 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. As it relates to our Inovio HPV-associated disease programs, we completed enrollment in REVEAL2, our second global Phase 3 clinical trial of VGX-3100 for cervical, high-risk squamous intraepithelial lesions, or HSIL. 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 REVEAL1 participants which show 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 and week 88. We continue to progress her 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. And this biomarker is 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 completed enrollment of 32 participants with HPV 6 and/or HPV 11-associated RRP in our open label multicenter Phase 1/2 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 1/2 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 Reardon, a key opinion leader in brain tumors and our coordinating PI for our GBM-001 trial, presented updated data from our Phase 2 trial for INO-5401, our DNA medicine for patients with newly diagnosed glioblastoma or GBF at the SITC preconference 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 GBF. Overall survival at 24 months was 22% or 7 out 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.

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 development and -- 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 yearend financial summary. Peter?

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 31, 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 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 INO-4800. Our net loss for the quarter and year ended December 31, 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 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 trials 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 31, 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-tax 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.

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 thermostability profile. We look forward to sharing our continued progress as we advance these efforts. With that, let’s open the call for questions. Operator?

[Operator Instructions] Our first question will come from Geoff Meacham of Bank of America. Please go ahead.

Hi. This is Alex Hammond [ph] on for Geoff Meacham. Thank you for taking our question. So, on VGX-3100, will you utilize a biomarker data generated in combo with QIAGEN to bucket patients for the Phase 3 REVEAL2 trials? And have you discussed the path forward for submission with the FDA? Thank you.

Yes. Thank you, Alex for VGX-3100 question. I will turn it over to our program lead, Jeffrey -- Dr. Jeffrey Skolnik. Jeffrey?

Sure. Thanks, Joseph. And thanks for the question. So, 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 basically prognosticate or predict and 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 validated they have the potential to identify those women. And we are continuing to move that opportunity forward. As you know, both REVEAL1 and REVEAL2 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 regulatory colleagues and to best understand the path forward for this biomarker. And as you know, REVEAL1 has shown us that we can without the biomarker show in the valuable population, a statistically significant difference between VGX-3100 women clearing and resolving cervical HSIL secondary 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.

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. On just your trial, the INNOVATE trial, Joseph and team, Sanofi and GSK reported a vaccine efficacy of 58%, right? And 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 bivalent vaccines against Omicron. So, it seems you’re getting proactive in trying to get ahead of what Omicron can do to current vaccines in development or approvals. How are you thinking if you were to get that protocol amendment? Would you essentially market the vaccine 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 3, and I just got a quick follow-up.

Yes. 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, 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. 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 INO-4800 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 INO-4800 has a strong position once we get the Phase 3 data, and once we get the emergency and full licensure to demonstrate this -- benefits as a vaccine against SARS-CoV-2.

Yes, great. Joe, I mean, you’re in vitro data matches up pretty well against some of the commercial and vaccines in approval. Just quick question on WHO trial, are they planning on doing any protocol amendments there to also kind of for the Omicron and maybe future variants, just any updates there? Thanks for the questions.

Yes. As a process, 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. So, as you know, Solidarity Trial Vaccines is run and sponsored by the WHO and. And they have the full control. And 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.

Next question comes from Gregory Renza of RBC Capital Markets.

This is Yinglu [ph] for Greg. Thank you for taking our questions. Maybe first question on 4800, I was just wondering if you could provide some more color on your expectations around the steps to seek regulatory approval to meet 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.

So, 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 as expediently as possible across these regulatory bodies and their local ethics committees. We think, we have a strong position, and 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. And 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 is fed into our INNOVATE trial execution.

And maybe another question on 3100. Just wondering when should we expect to learn more granularity on the timeline for REVEAL2 trial readout. And I just wanted to clarify if there were any design adjustments of the trial. Thank you.

Yes. I’m going to take it and if there’s a follow-up question I will let our expert, Dr. Skolnik address that. But we fully enrolled about 200 participants in REVEAL2 in the fourth quarter as the last patient in 40 weeks of trial follow-up. So, our projection is we would have preliminary data safety and immunogenicity and efficacy in the fourth quarter of 2022. And no, we haven’t had any changes to REVEAL2 protocol. It’s identical to REVEAL1 except the follow-up, safety follow-up is one month instead of one year.

The next question comes from Stephen Willey of Stifel. Please go ahead.

Are you able to say how many patients were enrolled into INNOVATE at the time of the pause?

Yes. No, we -- it’s our policy not to provide up to date information. But we were -- we have 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. And then, maybe just to follow-up on the last question, right? So, when you look across the Phase 3 vaccine trials, I guess, whether it’s, Novavax or Pfizer, Moderna, the incidence rate of severe disease that is seen across those studies is anywhere between like 1 and 1,000 participants, 1 to 4,000 to 5,000 participants. So, I guess, in the context of how they 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 a low single digit number of severe events? And I guess, how do you contemplate that from a statistical power perspective, when you think about not meaningfully changing the size of the study?

Yes. 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 incidences 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.

Okay. And then, maybe just a question for Peter. How should we think about just kind of where OpEx trends here 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 going to see it remain fairly consistent with the other quarters, running in the $65 million burn range about, per quarter.

The next question comes from Roger Song of Jefferies. Please go ahead.

Great. Thank you for taking our question. So, one question that’s related to the booster. So, Joseph, can you just comment what the timing will look like for those Phase 1/2 data for the booster, heterologous or the homologous? And also, what will be the next step for the booster regimen?

Yes. 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, Advaccine. So, we expect the data from that trial sometime in the next quarter. In terms of additional heterologous boost, 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 other most prolifically utilized primary vaccine 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. That’s very helpful. Thank you. And also, we know you have your own pan-coronavirus vaccine 4802, just any kind of update regarding the progress?

Yes, absolutely. Maybe I’ll turn to Dr. Broderick, to address that. Kate?

Yes. Thanks very much. It’s great question. Really, 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 INO-4802 has shown pre-clinically and we continue to develop it. But 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. 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.

Got it. Okay. Thanks for taking our questions.

Yes. Thank you.

The next question comes from Yi Chen of H.C. Wainwright. Please go ahead.

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.

As we mentioned before, remember that both, REVEAL1 and REVEAL2 always anticipated examining, looking at this potentially predictive biomarker. So, it has always been our attention to ask a biomarker question both REVEAL1 and REVEAL2. 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 then, 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.

And the next question is, with respect to 5401 in GBM, what is the next step and what are the expected catalysts for this program this year?

Well, we’re continually following these patients. Jeffrey Skolnik share 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. So, we’ll continue to follow them, we’re evaluating our next steps with our collaborator Regeneron. So, I think overall survival, as well as the following of these surviving participants will give us additional insights into the path forward for this program.

And my last question is, when do you expect to report results from Phase 2 trial of 4700 to MERS vaccine?

Yes. So, I’m going to turn that over to Kate. Kate?

I’m so sorry. Could you repeat the question for me? The line went bad for a minute part.

When do you expect to report results from the Phase 2 trial of the MERS vaccine?

Yes. Great question. So, we’re currently still enrolling, and at the moment, we’re about halfway through now. So, probably by Q3 of this year.

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 ‘22 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.