Q1 2022 Inovio Pharmaceuticals Inc Earnings Call
Jacqueline Shea: While we have many challenges to face, I believe strongly in the potential of our DNA medicine technology and its ability to significantly and positively affect human health. We are committed to fulfilling the potential of our DNA medicines platform, where we seek to make the greatest impact on health globally. This has served as the foundation for all our efforts to date, and it continues to guide and underpin our work going forward.
We have many challenges to face I believe strongly in the potential of our DNA medicine technology.
And its ability to significantly and positively affect human health.
We are committed to fulfilling the potential of our DNA medicines platform, where we seek to make the greatest impact on health globally.
This has served as the foundation for all our efforts to date and it continues to guys and underpin our work going forward.
Jacqueline Shea: I would also like to thank Dr. Joseph Kim for his many contributions to Inovio as its co-founder. Joseph is a true entrepreneur and has been a pioneer in the field of immunotherapies and vaccines. Now, turning to today's financial and program update, let's begin with our COVID-19 vaccine. As the COVID-19 pandemic evolves towards the endemic phase, the need for booster vaccines to protect against severe illness and death represents a growing and strategic opportunity.
I would also like to thank talk to Joseph Kim for his many contributions to <unk> co founder.
Joseph at the true entrepreneur and has been a pioneer in the field of immunotherapy and vaccine.
Jacqueline Shea: In light of this, we now believe that Inovio can have the greatest impact and serve the most pressing public health needs by focusing our COVID vaccine on our heterologous booster strategy, where a different vaccine is used to boost a primary vaccination. Toward that goal, we are advancing our efforts to evaluate Zyno4800 as a booster and a non-inferiority clinical trial compared to currently authorized COVID-19 vaccines. Inovio is continuing discussions with regulators in African countries regarding potential regulatory pathways for licensure.
Now turning to todays financial and program update let's begin with our COVID-19 vaccine.
As the COVID-19 pandemic both towards the endemic phase the need for a boost the vaccine to protect against severe illness and death represents that growing and strategic opportunity.
In light of this we now believe that an IPO can have the greatest impact and some of the most pressing public health needs by focusing our carpet vaccine on our heterologous booster strategy.
And this is where a different vaccine if used to boost our primary vaccination.
Towards that goal, we are advancing our efforts to evaluate Sino 4800, as a booster of non inferiority clinical trials compared to currently authorized COVID-19 vaccine.
<unk> is continuing discussions with regulators select countries regarding potential regulatory policy rates the license yet.
Jacqueline Shea: Importantly, these efforts are in addition to the heterologous boost trial conducted by our partner Advaxine, the preliminary data for which we will review in a moment. As we shift to prioritize our heterologous boost strategy, we will discontinue our global phase 3 Innovate trial. This decision reflects emerging global data that indicate a lower incidence of severe COVID-19 cases caused by the Omicron variant and its progeny, which would necessitate a subsequent increase in trial size and costs for Inovate to obtain an efficacy readout against severe disease.
Importantly, these efforts are in addition to the heterologous spruce trial conducted by our partner <unk>.
Preliminary data for which we will review in a moment.
As we shift to prioritize our heterologous brief strategy, we will discontinue global phase III innovate trial.
This decision reflects the emerging global data that indicates a lower incidence of severe COVID-19 cases caused by the <unk> borrowings on its separate images.
Which would.
Which would necessitate a subsequent increase in trial size and cost.
The innovate to obtain an efficacy readouts against severe disease.
Jacqueline Shea: We believe the shift places Inovio's COVID-19 vaccine in a stronger strategic position to contribute to public health initiatives for COVID-19 going forward. It also allows us more flexibility in continuing to develop our DNA medicine platform. We will also provide an update today about a recent meeting that we had with the FDA regarding BGX 3100, our HPV vaccine against HPV 16 and 18 associated cervical high-grade squamous intraepithelial lesions (or HSIL). As you know, we are close to completing the Reveal 2 Phase 3 study with this therapy and have been evaluating the use of a biomarker to identify those women who will be most likely The FDA has indicated that we will need at least one, if not two, additional trials to obtain a marketing authorization for the product candidate.
We believe this shift places <unk> COVID-19 vaccine in the strongest strategic position to contribute to the public health initiatives to COVID-19 going forward.
It also allows us more flexibility and continuing to develop <unk> DNA medicines platform.
We will also provide an update today about a recent meeting that we had with the FDA regarding the <unk> 3100, our HPV vaccine against HPV 16, and 18 associated cervical high grade squamous intra <unk> lesions or H sale.
As you know we are close to completing the reveal two phase III study with this therapy and have been evaluating the use of a biomarker to identify those women who will be most likely to benefit from <unk> 3100.
The FDA has indicated that we will need at least one if not two additional trials to obtain a marketing authorization for the product candidate.
Jacqueline Shea: My colleague Jeffrey Skolnik will be describing this development in more detail later in our call today, but first, I'm pleased to introduce Dr. David Leibovitz, Inovio's SVP of Clinical Development for Infectious Diseases and our COVID-19 clinical lead, to provide additional commentary on our COVID-19 program. Thank you very much, Jackie. And greetings, everyone.
My colleague Jefferies Goldman will be describing this development in more detail later in our call today.
But first I'm pleased to introduce Dr. David Leibowitz, and <unk> SVP of clinical development for infectious diseases on our COVID-19 clinical needs to provide additional commentary on our COVID-19 program.
Dave.
Thank you very much Jackie.
And greetings everyone.
Jacqueline Shea: We believe the increased global awareness about the significance of vaccine-induced T cell responses and Durability of Protection for Effective Booster Vaccines works to the advantage of one of INO4800's key strengths, its ability to generate CD8 positive T cell responses. We're pleased to share encouraging preliminary data from our partner Advaxine's 267-participant heterologous boost trial, which we believe supports our decision to pursue the heterolog Add vaccines, heterologous boosts, and clinical trial assessment of immune responses from a two-dose primary series of an inactivated COVID-19 vaccine, followed by a boost with INO4800 after three or six months.
We believe the increased global awareness about the significance of vaccine induced T cell responses and durability of protection for effective booster vaccines works to the advantage of one of INR 48, hundreds key strengths is.
This ability to generate CDA positive T cell responses.
We are pleased to share encouraging preliminary data from our partner AD vaccines 267 participants enrolling as Bruce trial, which we believe supports our decision to pursue the heterologous boost pathway.
And vaccines heterologous clinics.
Clinical trial assessment of immune responses from a two dose primary series of an inactivated COVID-19 vaccine.
Followed by a boost with INR 4800, after three or six months.
Jacqueline Shea: Interim immunogenicity data showed that using INO4800 as a booster after 6 months resulted in a 6.3-fold increase in T cell immune response. In a separate ad vaccine study where three doses of an inactivated COVID-19 vaccine were assessed, the cellular response increased by 1.7%. Further, the highest booster effect of INO4800 was observed with a 2 milligram dose of INO4800 delivered six months after a primary series with an inactivated vaccine. Following INO4800 vaccination, the preservation of cross-reactive T cell responses remains a consistent observation against multiple SARS coronavirus 2 variants of concern, including Omicron, without a significant loss in the response magnitude. T cells that can recognize SARS-coronavirus-2 may play a role in reducing disease severity.
In terms of Immunogenicity data showed that using INR 4800, as a booster after six months resulted in a 6.3 fold increase in T cell immune response.
And a separate AD vaccine study, where three doses of an inactivated COVID-19 vaccine were assessed to cellular response increased by 1.7 fold.
Further the highest booster effective INR 4800 was observed with the two milligram dose of INO 4800 delivered six months after a primary series within an activated vaccine.
Following INR 4800 vaccination.
Reservation of cross reactive T cell responses remains a consistent observation against multiple Sars coronavirus, two variants of concern, including AUM across without a significant loss in the response magnitude.
T cells that can recognize Sars coronavirus, two may play a role in reducing disease severity.
Jacqueline Shea: Therefore, INO4800 has the potential to play an important role in reducing incidents of severe COVID-19 cases, which could reduce hospitalizations as the virus continues to mutate and new variants arise. This heterologous boost study further supports the advantages of our DNA medicines platform, including our ability to elicit T cell responses, potential for re-administration, temperature stability, and favorable safety profile.
Therefore, INR 4800 has the potential to play an important role in reducing incidence of severe COVID-19 cases, which could reduce hospitalizations as the virus continues to mutate and new variants arise.
This heterologous boost study further supports the advantages of our DNA medicines platform, including our ability to elicit T cell responses.
Potential for re administration temperature stability and favorable safety profile.
Jacqueline Shea: Building on our productive collaboration for the clinical development of INO4800 over the past year and a half, we're planning to expand our partnership with Advaxine with an expanded focus on heterologous boosting and new constructs covering future variants. This arrangement will enable Inovio and Advaxine to leverage Advaxine's multiple manufacturing sites in China and access opportunities globally. I'll now turn the call over to Inovio's SVP of clinical development, Dr. Jeffrey Skolnick, for an update on our HPV and oncology programs.
<unk> on our productive collaboration for the clinical development of INR 4800 over the past year and a half.
We're planning to expand our partnership with add back seen with an expanded focus on heterologous boosting and new construct covering future variants. This arrangement will enable an OBO and add vaccine to leverage and vaccines multiple manufacturing sites in China and access.
Yes opportunities globally.
I'll now turn the call over to <unk> SVP of clinical development, Dr. Jeffrey Skolnik for an update on our HPV and oncology programs Jeffrey.
Thank you Dave.
Jacqueline Shea: Thank you, Dave. We'll now talk about Inovio's HPV-associated disease program. We recently met with representatives from the U.S. FDA regarding our late-stage clinical trials for VGX3100 against HPV16 and 18-associated cervical high-grade squamous intraepithelial lesions, or HCLs. And during this meeting, the FDA advised us that our regulatory strategy to use REVEAL-2, which is the second of two Phase III trials for VGX3100, to evaluate efficacy in a biomarker-selected population would not provide sufficient evidence to support approval of a potential marketing application for VGX3100 in that biomarker population.
We will now talk about <unk> HPV associated disease programs. We recently met with representatives from the U S. FDA regarding our late stage clinical trials for <unk> 3100 against HPV 16, and 18 associated cervical high grade squamous intraepithelial lesion.
Jacqueline Shea: The FDA recommended using REVEAL-2 as an exploratory study to evaluate a biomarker-selected population and then conduct one or two additional prospective, well-controlled trials in the biomarker-selected population to be more likely to provide sufficient evidence to support approval of a marketing application. To better assess potential efficacy in that biomarker-selected population, we plan to amend the fully enrolled Reveal-2 to revise the primary analysis population Both the biomarker-positive population and the all-commerce population will be analyzed with respect to efficacy.
<unk> or <unk>.
And during this meeting the FDA advised us that our regulatory strategy to use reveal two which is the second of two phase III trials for <unk> 3100 to evaluate efficacy in a biomarker selected population would not provide sufficient evidence to support approval.
Of a potential marketing application for <unk> 3100 in that biomarker population.
The FDA recommended that using reveal two is an exploratory study to evaluate a biomarker selected population and then to conduct one or two additional prospective well controlled trials in the biomarker selected population would be more likely to provide sufficient evidence to support it.
Approval of a marketing application.
To better assess potential efficacy in that biomarker selected population, we plan to amend the fully enroll reveal two to revise the primary analysis population from the all comers to the biomarker positive population.
The biomarker positive population and the all comers population will be analyzed with respect to efficacy.
Jacqueline Shea: We will continue our Reveal II trial to completion and will assess the path forward for the VGX3100 program following analysis of the Reveal II results. Given the likelihood of at least one additional trial, we no longer expect to submit a BLA for VGX3100 in 2023. We maintain full conviction in our DNA medicines and in our development programs for HPV diseases. Even our prior evidence of our DNA medicines platform, specifically VGX3100, to both regress lesions caused by HPV16 and HPV18 and to clear the HPV16 and HPV18 virus from those lesions.
We will continue our reveal two trial to completion and will assess the path forward for the <unk> 3100 program.
Following analysis of the reveal two results given the likelihood of at least one additional trial, we no longer expect to submit a BLA in 2023 for <unk> thousand 100.
We maintain full conviction in our DNA medicines.
And in our development programs and HPV diseases, given our prior evidence of our DNA medicines platform, specifically <unk> 102, both regress lesions caused by HPV 16, and 18 and to clear HPV 16, 18 virus from those lesions.
Jacqueline Shea: With respect to INO3107, our DNA immunotherapy candidate to treat recurrent respiratory papillomatosis, or RRP, a rare and orphan disease, we've completed enrollment in our open-label, multi-center, phase 1-2 clinical trial of 32 participants with HPV 6 or 11 associated RRP. This yet incurable disease is characterized by the growth of small tumors or papillomas in the respiratory tract caused by HPV and can lead to life-threatening airway obstruction.
With respect to INR 30, 107, our DNA immunotherapy candidate to treat recurrent respiratory papillomatosis or <unk>.
Our RP.
Rare and orphan disease, we've completed enrollment in our open label Multicenter Phase <unk> clinical trial of 32 participants with HBV six or 11 associated RP.
Yet incurable disease is characterized by the growth of small tumors, where papilloma is in the respiratory tract caused by HPV and can lead to life threatening airway obstructions.
Peter Kies: These papillomas often recur, requiring repeat intervention. Our trial includes adults with HPV6 or 11 RRP who have required at least two interventions in the past year to remove the disease. Trial participants will first undergo removal of their papillomas and will then receive up to four doses of INO3107 once every three weeks. The efficacy endpoint will be a reduction in the frequency of cervical interventions following the first dose of INO3107, relative to the frequency prior to clinical study therapy.
These papilloma is often recur requiring repeat interventions.
Our trial includes adults with HPV, six or 11, RP, who have required at least two interventions in the past year to remove disease trial participants will first undergo removal of their papilloma has and will then receive up to four doses of IL 30, 107%. Once every three weeks.
The efficacy endpoint will be a reduction in the frequency of surgical interventions. Following the first dose of IL 30 107.
Relative to the frequency prior to clinical study therapy.
Peter Kies: We expect preliminary efficacy, safety, and immunogenicity data from a portion of trial participants in the second half of this year, and based on these results, we will then determine next steps for clinical development. Regarding Inovio's immuno-oncology programs, we are very excited that our novel trial of DNA Medicine's INO5401 and INO9012, in combination with Regeneron's PD-1 inhibitor, Libtio, for the treatment of newly diagnosed glioblastoma or GBM was selected for an oral presentation at next month's ASCO annual meeting.
We expect preliminary efficacy safety and Immunogenicity data from a portion of trial participants in the second half of this year and based on these results. We will then determine next steps for clinical development.
Regarding <unk> immuno oncology programs, we are very excited that our novel trial of DNA medicines, INR 50, 401, and INR 90, 12 in combination with Regeneron PD one inhibitor live tayo.
For the treatment of newly diagnosed glioblastoma or GBM was selected for an oral presentation at next month's <unk> annual meeting.
Peter Kies: The full text of the abstract providing overall survival, Safety, and Immunogenicity Data will be available on the ASCO meeting website beginning May 26th. And now I'd like to turn the call over to Peter Kies, our Chief Financial Officer, for our first quarter financial summary.
The full text of the abstract providing overall survival.
Safety and Immunogenicity data will be available on the ESCO meeting website, beginning may 26th.
And now I'd like to turn the call over to Peter Keith <unk>, Our Chief Financial Officer for our first quarter financial summary, Peter.
Peter Kies: Thank you, Jeffrey. And good afternoon, everyone. We finished the first quarter with 360.4 million in cash, cash equivalents, and short-term investments, compared to 401.3 million as of December 31, 2021. As of March 31, 2022, Inovio had 226.5 million common shares outstanding and 247.8 million common shares outstanding on a fully diluted basis.
Thank you Jeffrey and good afternoon, everyone.
We finished the first quarter with $364 million in cash cash equivalents and short term investments compared to $401 3 million as of December 31, 2021.
As of March 31, 2022, and nobody will have $226 5 million common shares outstanding.
And $247 8 million.
Common shares outstanding on a fully diluted basis.
Peter Kies: Total revenue was $199,000 for the first three months ended March 31, 2022 compared to $371,000 for the same period in 2021. Total operating expenses were $71.9 million for the first quarter of 2022 versus $52.9 million for the first quarter of 2021. Our net loss for the quarter was $79.1 million, or $0.36 per share.
Total revenue was 199000 for.
For the first three months.
And at March 31, 2022 compared to <unk>.
371000 for.
For the same period in 2021.
Total operating expenses were 70, $171 9 million for the first quarter in 2022 versus $52 9 million for the first quarter in 2021 hour.
Our net loss for the quarter was $79 1 million or <unk> 36 cents per share.
Peter Kies: Basic and dilutive. That compares to a net loss of $54.4 million or $0.27 per share basic and dilutive for the same period in 2021. Inovio's research and development expenses were $56 million for the first three months of this year, compared to $39 million for the same period in 2021. The year-over-year increase in R&D expenses was primarily related to higher drug manufacturing and clinical trial expenses related to INO4800 and higher employee compensation.
Basic and dilutive.
That compares to a net loss of $54 4 million or <unk> 27 per share basic and dilutive for the same period in 2021.
<unk> research and development expenses were $56 million for the first three months of this year compared to 39.
For the same period in 2021.
The year over year increase in R&D expenses was primarily related.
Two a higher drug manufacturing and clinical trial expenses related to iron ore 4800, and higher employee compensation.
This increase reflects a $6 3 million dollar Contra R&D expense recorded from grant agreements.
These increases were offset by lower engineering service services and expense equipment related to our select euro three PSP device array automation project among other variances Jenna.
Peter Kies: This increase reflects a $6.3 million contra R&D expense recorded from grant agreements. However, these increases were offset by lower engineering services and equipment related to our Selectra 3PSP device array automation project, among other variants. General and administrative expenses were $16 million for the quarter, compared to $13.9 million for the same period in 2021. The year-over-year increase in G&A expenses was mainly related to an increase in employee compensation and insurance expenses, among other variances.
General and administrative expenses were $16 million for the quarter compared to $13 9 million for the same period in 2021.
The year over year increase in G&A expenses was mainly related to an increase in employee compensation and insurance expenses among other variances.
Jacqueline Shea: As a reminder, you can find our financial statements in this afternoon's press release as well as in the company's Form 10 Tech. Form 10Q filed with the SEC. And with that, I'll turn it back over to Jackie. Thank you. Thank you, Peter. Going forward, our commitment is to efficiently allocate our resources to our key programs in our pipeline to put Inovio in the best position to benefit patients, global health, and our stakeholders. For COVID-19, we are prioritizing our resources on a heterologous booster vaccine strategy, where our DNA vaccine platform, we believe, has advantages that can really make a difference.
As a reminder, you can find our financial statements in this afternoon's press release as well as in the company's Form 10-K Form 10-Q filed with the SEC.
And with that I'll turn it back over to MS. Jackie Thank you.
<unk>.
Thank you Peter.
Going forward, our commitment to efficiently allocate our resources to our key programs in our pipeline to put some <unk> in the best position to benefit patients clinical health and all stakeholders.
The COVID-19.
<unk> our resources on the Heterologous booster vaccines, Scott Jean <unk> DNA vaccine platform. We believe has advantages that can really make a difference.
Jacqueline Shea: For HPV, we are committed to delivering immunotherapies to address HPV diseases with an alternative to surgery by focusing on the biomarker-positive population in Reveal 2. Beyond the programs we've discussed on this call, we're also very excited about the upcoming milestones and data we have coming out later this year in our vaccine pipeline, including INO 45,000 for Lassa fever, INO 4700 for MERS, and INO 4201 We look forward to providing you with further updates on our pipeline in the coming months as our efforts continue.
The HPV, we are committed to delivering immunotherapies to address HPV diseases with an alternative to surgery.
Focusing on the biomarker positive population and reveal two.
Beyond the programs discussed on this call. We're also very excited about the upcoming milestones and dates that we have coming out later this year and our vaccines pipeline, including INR 45000, less the paper.
700.
Your line is now <unk> wanted the booster against Ebola.
We look forward to providing you with further updates on our pipeline in the coming months.
Quick right.
Jacqueline Shea: 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 and then one on your telephone keypad. If you're using a speakerphone, please pick up your handset before pressing the key.
With that let's open the call for questions operator.
Operator: To withdraw your question, please press star then 2, then first question comes up. From Jeff Meacham of Bank of America. Please go ahead. Good afternoon. This is Hao calling in for Jeff Mee-Chen.
We will now begin the question and answer session to ask a question you May Press Star then one on your telephone keypad.
If youre using a speakerphone please pick up your handset before pressing the keys.
To ensure your question. Please press Star then two.
The first question comes.
From Geoff Meacham of Bank of America. Please go ahead.
Jacqueline Shea: Thanks for taking my questions. So my first one is about the BGX3100. Given the change in primary endpoint, how is the trial powered, given that change, and if you have any idea yet about how many patients are actually in the biomarker-selected population versus the overall population?
Good afternoon. This is how can inflict estimation. Thanks for taking my questions. So my first one is about the bts extremely one hungry given the change of primary endpoint how is the trial powered.
Given that chance.
If you have any color about how.
How many patients have.
Actually the biomarker select population that's the overall population and then just a second one.
CEO transition could you provide any additional color about making the plans for CEO transition. Thank you.
Jacqueline Shea: And then just the second one is, you know, CEO transition. Could you provide any additional color about maybe the plan for CEO transition? Thank you. Thank you very much for the questions. I think for the first question, I'll hand over to my colleague Geoffrey Skolnick to answer that one, and then I'll take the question about the CEO transition. Geoffrey?
Okay. Thank you very much for the questions I think for the first question I'll hand over to my colleague Jeffrey Skolnik swamps that one and then I'll take the question about the CEO transition Jefferies. Thank you Jami. Thanks for the question so.
Jacqueline Shea: Thank you, Jackie. Thanks for the questions. With respect to your first question regarding the power of the biomarker, you know, again, our focus is really on identifying the population in whom VGX 3100 has the greatest potential to demonstrate efficacy. And as we've shared previously, we continue to move forward with the development of that biomarker. As it relates to the population within the study, while we haven't yet shared the percentage of patients that would be biomarker positive, what we can say is that we fully anticipate that the study is appropriately powered given the efficacy that we expect to see in the biomarker positive population. Again, that's specifically why we're really interrogating that particular question in the biomarker positive population for VGX3100 for cervical.
With respect to your first question regarding the power of the biomarker.
Our focus is really on identifying the population in whom VEGF 3100 has the greatest potential to demonstrate efficacy and as we've shared previously we continue to move forward with the development of that biomarker.
As it relates to the population within the study while we haven't yet shared the percentage of patients that would be biomarker positive.
What we can say is that we fully anticipate that the study is appropriately powered given the efficacy that we expect to see in the biomarker positive population again Thats, specifically why we're really interrogating that particular question in the biomarker positive population for Vijay.
<unk> thousand 100 for cervical disease. So the short answer is yes. The study is powered appropriately.
Okay.
Thank you Geoffrey.
Jacqueline Shea: So the short answer is yes, this study is powered appropriately. Thank you, Geoffrey. So with regard to the CEO transition, first of all, I'd like to say that I'm really honored to be entrusted by the board to lead Inovio into its next chapter. And I would also like to thank Dr. Joseph Kim, our co-founder, for his many contributions to Inovio over the years to date.
So with regards to the CEO transition first of all I would like to say that I'm really Amit spin trusted by the board to lead <unk> into its next chapter.
I would also like to thank Joseph Kim cofounder.
His many contributions to an IPO.
Year to date.
<unk> patients grow and evolve continually.
Jacqueline Shea: Here at Inovio, we remain focused on the road ahead as we seek to improve the lives of patients globally and support global public health. Our talented and dedicated teams continue to advance our efforts forward. Thank you. Thank you very much. The next question comes from Hartaj Singh from Oppenheimer. Please go ahead.
Parents of Nokia, We remained focused on the road ahead as we seek to improve the lives of patients globally and support global public health.
Our talented and dedicated team continue to advance our efforts forward.
Thank you.
Thank you very much.
The next question comes from <unk>.
<unk> from Oppenheimer. Please go ahead.
Operator: Great, thank you for a couple of questions. Just wanted to say, you know, my regards to Joseph in my interactions with him. I think he always tried his best; sometimes things didn't work out, but really wishing him the best and his team.
Great. Thank you couple of questions.
Just wanted to say my regards to Joseph.
And my interaction will not keep you always tried as best.
Things don't work out, but really wishing him the basketball and the team.
Jacqueline Shea: And Jacqueline, congratulations to you. You know, one quick question I would just have is, What is the possible future for the heterologous booster market? That market is sort of broadening and deepening as more people get their vaccine. What would be a potential pathway forward? I mean, would you just need to run a booster trial? And that would be it? Would you need a safety database? How long would you have to run it?
And Jeff Congratulations to you.
One quick question I would just have us.
<unk>.
Jacqueline Shea: Just any color there. And then I just got a couple of quick follows, Sure, Hartaj. And it's very nice to talk with you. So with regard to the questions around the heterologous booster pathway, this is a regulatory pathway that's been evolving rapidly over the past few months. And Inovio is in discussions with a number of regulatory authorities about the path forward. So I'll pass this over to Dave to see if he can add any further color there. But I would say this is an evolving landscape at the moment, and things are moving quickly. Dave?
What is.
Thanks to the heavy largest booster market that market sort of broadening and deepening as more people get their vaccine.
What would be a potential path going forward I mean would you just need to run a booster that will be it.
Would you need a safety database prolonged you have to run it just any color there and then I've just got a couple of quick follow ups.
Yes, sure Hi Tech and its pretty nice to talk with you.
So with regards to the questions around the heterologous booster caused by this is the regulatory pathway that has been evolving rapidly over the past few months and <unk> been in discussion with a number of regulatory authorities about the path forward.
So I'll pass it over to Dave to see if he can add any further color that I would say the system evolving landscape at the moment and things are moving quickly.
<unk>.
Jacqueline Shea: Yeah, thank you, Jackie, and thank you for your question. Yeah, as Jackie said, we are continuing discussions with regulators in our target countries on regulatory pathways for licensure. But we obviously can't comment on behalf of the regulators.
Yes, Thank you Jackie and thank you for your question.
As Jackie said, we are continuing discussions with regulators in our target countries on regulatory pathways for licensure.
We obviously can't comment on behalf of the regulators, but we are seeing more and more.
Jacqueline Shea: But we are seeing more and more arguments for heterologous boost. We do understand that we will need a safety database, and as part of those discussions with the regulators, we're determining the size of that database that will be required. Great. Thank you. Thank you for the answers.
Arguments for heterologous boosting.
We do.
We do understand that we will need a safety database and as part of those discussions with the regulators. We're determining the size of that database that will be required.
Jacqueline Shea: Just a few quick questions. What's the status of your manufacturing relations with Thermo Fisher? I believe that they have dedicated or are thinking about dedicating an entire facility in California to the manufacturing of DNA positive. And then secondly, if you can just kind of give us an indication, what are the parameters for the burn?
Great. Thank you. Thank you for the answers I just a quick two quick questions. What's the status of your manufacturing relationship with Thermo Fisher I believe that they have dedicated or thinking about dedicated an entire facility in California.
Not a question of being a positive.
Then secondly.
If you can just kind of give.
Give us an indication what are the parameters.
The burn how far could you go out with some of the projects you're undertaking some of the projects are shifting around and thanks for the question.
Yes.
Jacqueline Shea: How far could you go with some of the projects you're undertaking, some of the projects you're moving around? And thanks for the question. Thank you, I'll take the Thermo Fisher question and then Peter, maybe, could handle the runway question. With regard to Thermo Fisher, they are a key partner for us in our manufacturing consortium, and we continue to work very closely with them to scale up our manufacturing processes, and they're going to remain key to our plans going forward. Peter, do you want to talk about the cash flow issues here? Yes, thanks. Hi Hartaj, this is Peter.
Okay. Thank you I'll take the Perm official question and then Peter maybe could handle the run my question.
Yeah with regard some efficiency that thermo Fisher, a key partner for us in our manufacturing consortium and we continue to work very closely with them to scale up our manufacturing processes and they're going to remain key to our plans going forward.
Peter do you want to talk about the cash yes.
Hi, Charles this is Peter.
Peter Kies: So, you know, Hartaj, we definitely anticipate a reduction in our monthly burn. Right now, we're evaluating the impact of just continuing to innovate, and we're also reprioritizing our resources across our pipeline programs. So, we will provide updates when we have more information to disclose, and that should be a little bit later this summer.
So we do anticipate definitely a reduction in our monthly burn.
Right now were evaluating the impact of just continuing to innovate.
And we're also re prioritizing our resources across our pipeline program. So we will provide updates when we have more information to disclose.
And that should be a little bit later.
This summer.
Peter Kies: Yep, understood, Peter. Thank you, Jacqueline. Thank you, Peter. Thank you. Thank you. As a reminder, if you have a question, please press star 1. The next question comes from Roger Song from Jeffreys. Please go ahead.
Yep understood Peter Thank you Jack and thank you Peter and regarding here.
Thank you. Thank you.
As a reminder, if you have a question please press star one.
The next question comes from Roger song from Jefferies. Please go ahead.
Operator: Great, thank you for taking the question. Maybe just as a follow-on for Heather Loger's COVID program, since you have pretty good this kind of cellular response after the inactivated vaccine as a booster, just curious, do you have any humoral data, response data there? And I think, you know, also I understand you're having discussions with the different regulators, but is it possible that this cellular response will be the primary endpoint for Heather Loger's study, or like other vaccines so far, do they need to be approved based on the humoral response data? Thank you. Okay, thank you.
Great. Thank you for taking the question, maybe just as a follow up for the had a longer Covia program.
You have pretty good at this.
Just to kind of accelerate.
Yes.
Sure.
We activated a vaccine booster just curious do you have any humeral data that's bulk data there.
And I think also I understand you are having discussion with <unk>.
Regulators.
Possible.
While overall response will be the primary endpoint for that how the logos that <unk> or.
Like others.
Vaccines, so far data should be approved based on <unk>.
Thank you Laurel response data thank you.
Jacqueline Shea: So with regard to the heterologous boost strategy, I think I'm going to ask Dave to comment on the endpoints, but what I would say is, you know, we see a real advantage of our DNA medicines program and our DNA platform generally in the heterologous boost space. We think we're generating, you know, really unique T cell responses, which can be incredibly useful.
Okay. Thank you.
So with regards to the heterologous strategy.
I'm going to ask Dave to comment here on the endpoints, but what I would say, we see a real advantage.
DNA medicines program.
DNA platform generally in the heterologous space. We think we are generating really unique T cell responses, which can be incredibly useful.
Jacqueline Shea: With regard to the antibody data from the ad vaccine studies, we hope to make that available later on over the summer, and we'll be publishing that data. And I'll pass it over to Dave to comment on the endpoint piece. Thank you, Jackie, and thank you for the question. Yes, so it's a very good question. We do know that the scientific community is becoming increasingly aware of the critical role that T cells play in the prevention of severe COVID, and over time, we believe that this will be a key consideration in regulatory decision-making. But you are correct. Right now, the pathway forward for heterologous boosts appears to be non-inferiority of the humeral immune response.
With regards to the antibody data from the AD vaccine studies, we hope to make that available later on over the summer and we'll be publishing that data and I'll pass it over to Dave to comment on the <unk> piece.
Thank you Jackie and.
And thank you for the question.
Yes, so and so it's a very good question.
I do know that the scientific community is becoming increasingly aware of the critical role that T cells play in the prevention of severe COVID-19.
And over time, we believe that this will be a key consideration in regulatory decision making.
But you are correct.
Right now.
The pathway forward for heterologous boost.
Here's to be non inferiority of the humoral immune response and.
Jacqueline Shea: And as I said, we're in discussions with regulators, which will include a discussion about NPR. Got it, yeah, so thanks for the comment. And then just a very quick one about 5401, the GBM program.
As I said, we're in discussions with regulators, which will include a discussion around endpoints.
Got it yes, so thanks for the comment.
And then just a very quick one for.
Because we will along with GBM program.
Jacqueline Shea: What will be the next step for this program, and when will we do it? Thank you. Thank you, Roger. So I'm going to hand that question over to my colleague, Jeffrey.
What will be the next step for this program and when will be.
Can see some additional clinical data on that program. Thank you.
Thank you Roger.
I'm going to hand that question over to my colleague Geoffrey.
Jacqueline Shea: I would just say we're very excited to be having that presentation at ASCO, so I think that'll be the next opportunity to talk about that data for Jeffrey. Yeah, thanks, Roger, for the question. Thank you, Jackie.
I'd just say we are very excited to be having that presentation of our scope.
So I think that'll be the next opportunity to talk about that say to us that Jeffrey yes.
Jacqueline Shea: I would just echo what Jackie's just shared, which is that we're extremely pleased to have the opportunity to present an oral presentation this year at ASCO regarding the newly diagnosed GBM data. And, you know, essentially following that presentation, we are going to continue to take a look at the totality of the GBM space and 5401 and really think about what our next step should be within the GBM landscape. So I would say just to stay tuned.
Yes, Thanks Raj for the question. Thank you Jackie I would just echo what Jack has just shared which is that certainly we are extremely pleased to have the opportunity to present, an oral presentation. This year at <unk> regarding the newly diagnosed GBM data and essentially following that presentation.
Operator: All right, great. Thanks. That's it for us.
We're going to continue to take a look at the totality of the GBM space and 50, 401, and really think about what our next steps should be and within within the GBM within the GBM landscape. So I would say just stay tuned.
Alright, great. Thanks.
Thank you.
Thank you Roger.
Operator: Thank you. Thank you, Roger. The next question comes from Yi Chen from H.C. Wainwright.
The next question comes from <unk> Chen from H C. Wainwright. Please go ahead.
Operator: Please go ahead. Thank you for taking my questions. My first question is, could you please give us more insights on the basis, I mean the reason, the basis based on which the FDA provided their recent opinion regarding the Review 2 trial? Was it the Review 1 data, or was there something else?
Okay. Thank you for taking my questions.
First question is could you please give us more insights.
Basis.
The basis based on which the FDA.
Provided a recent opinion regarding to review two trial.
To review, one data or was there something else.
Jacqueline Shea: Thank you, Lee. That's it. That's a great question. So this really came from an interaction with the FDA, an interaction that we requested. So Geoffrey, can you provide some further context?
Thank you Lee.
That's a great question.
So this really came from an interaction with the FDA and interaction that we requested.
Can you provide some further context sure so.
Jacqueline Shea: Sure. Thank you for the question. Certainly, with respect to the opportunity to speak with FDA, as Jackie just suggested, this was a meeting that we essentially wanted to hold with FDA, specifically, again, as we talked about before, to really find a pathway forward for VGX3100 in those women with cervical dysplasia for whom VGX3100 had the greatest potential in terms of epidemiology. And so, in terms of the path forward, while, again, we certainly would not speak for regulatory agencies, what they shared with us was essentially consistent with the pathway forward in a biomarker-selected population.
Thank you for the question certainly with respect to the opportunity to speak with FDA.
Jackie just suggested.
This was a meaning that we essentially wanted to hold with the FDA, specifically again as we talked about before to really find a pathway forward for <unk> thousand 100, and those women with cervical dysplasia for whom.
<unk> 100 had the greatest potential for efficacy.
So in terms of the path forward, while again, we certainly would not speak for regulatory agencies, what they shared with US was essentially consistent with the pathway forward in a biomarker selected population.
Jacqueline Shea: So, you know, ultimately, what we're really aiming to do is to identify that population of women for whom 3100 is most likely to be efficacious. And that's really where our conversations with FDA have been. And could you tell us which countries you're going to pursue this? COVID-19 Heterologous Post-Test Strategy.
Ultimately, what we're really aiming to do is to identify that population in women for whom 3100 is most likely to be efficacious and thats really where our conversations with FDA have centered.
Got it.
Okay.
Thomas.
What are the countries in which youre going to pursue.
Koby.
That's where logos to strategy.
Okay.
Jacqueline Shea: So, what I can say here is that we're currently in discussions with regulators in a number of countries and we hope to be making announcements about which countries will be pursuing our heterologous boost approaches in the coming months, but I think it's a little early to comment on that yet. Thank you. And my last question is, will Inovio consider adding additional candidates to the pipeline? That's a great question.
But what I can say here.
We're currently in discussions with regulators in a number of countries.
<unk>.
Making announcements about which countries will be pursuing a heterologous based approaches in the coming months, but I think it's a little early to comment on that yet. Thank you.
Got it.
Question as well.
Would you consider adding additional candidates into the pipeline.
Jacqueline Shea: So, we are really confident in our DNA medicine technology. We can do a lot of different things. We have a strong pipeline for HPV, we have our I.O. candidates, and we have our I.D.
That's a great question. So we are really competent DNA medicine technology, we can do a lot of different things we can.
We have a strong pipeline in HBV, we have our Io candidates and we have.
Vaccine candidates. We also have some early stage products and team ops.
Bite specifics, however, I think what's really important to us is moving our key programs forward and really focusing our efforts and resources on moving those programs forward.
Jacqueline Shea: vaccine candidates. We also have some early stage products in DMAPs and bispecifics. However, I think what's really important to us is moving our key programs forward and really focusing our efforts and resources on moving those programs forward. We have a number of key data points coming up over the coming year and early into next year, and we're going to really be looking at the data and focusing on what we think is the best path forward and the best way to bring our DNA medicines to the patients who need them. So, I would say it's a question of looking at the data and really focusing on the best opportunities for patients and for our stakeholders.
A number of key data points coming out.
The coming year and early into next year, and we're going to really be looking at the data and focusing on what we think is the best path forward and the best way to bring our DNA medicines to the patients who need them. So.
So I would say, it's a question looking at the data and mainly focusing on the best opportunities.
Patients and prostate holders.
Thank you.
Okay.
Jacqueline Shea: Thank you. This concludes our question and answer session. I would like to turn the conference back over to Dr. Jackie Shea, President and CEO, for closing remarks. Thank you very much. And thank you all for the questions and to those who joined us today. As I stated, Inovio remains focused on DNA medicines technology and our innovative pipeline to save lives and improve global health. We have several catalysts later this year and early next year with important data readouts for Rivial 2, RRP, MERS, Lassa, and Ebola.
This concludes our question and answer session I would now like to turn the conference back over to Dr. Jackie Shea President and CEO for closing remarks.
Jacqueline Shea: I look forward to updating you on our program development and speaking with you again on the company's next earnings call in August. Have a good evening, everyone. Goodbye. The conference is now concluded. Thank you for attending today's presentation. You may now disconnect.
Thank you very much.
Thank you all put the questions and to those who joined us today.
As I stated <unk> remained focused on DNA medicine technology, and innovative pipeline to save lives and improve global health.
We have several catalysts slated this year and early next year with important data readouts for reveal two <unk>.
P Myers LASA and bipolar.
I look forward to updating you on our program development and speaking with you again on the company's next earnings call in August .
Have a good evening everyone.
Goodbye.
The conference has now concluded. Thank you for attending today's presentation you may now disconnect.