Q3 2021 Inovio Pharmaceuticals Inc Earnings Call

Good day and welcome to the no.

<unk> third quarter 2021 financial results conference call.

All participants we unless the only man should any assistance. Please signal conference specialist by pressing the star followed by zero.

After today's presentation there'll be an opportunity to ask questions.

Last few questions 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 turn the conference over to <unk> Senior director of Investor Relations. Please go ahead.

Thank you operator.

Afternoon, and thank you for joining the <unk> third quarter 2021 earnings conference call.

Joining me on today's call are Dr. Joseph Kim President and CEO, Mr. Peter Keyes, Chief Financial Officer Dr.

Dr. Jackie Shea Chief operating officer Dr.

Dr <unk> <unk>, Chief Scientific Officer Dr.

Dr. Jeffrey Skolnik senior Vice President of clinical development Dr.

Dr. Anza Mammen senior Vice President of clinical development and Dr. Kate Brodrick Senior Vice President of research and development.

For today's call, we will review, our corporate financial information for the third quarter ending September 32021.

We will also discuss our COVID-19 vaccine development efforts that address both current and future variants of concern as well as our efforts around both homologous ahead or log is boosting. Additionally.

Additionally, we will review other recent developments associated with the <unk>, various therapeutic and vaccine programs across our DNA medicines platform.

Among our recent updates will address the progress from our company's global Phase III innovate trial, which involves our COVID-19, DNA vaccine candidate INO 400, with our partner and vaccine as well as our announcement. This morning that the U S food and drug administration has lifted the partial clinical hold of the phase III segment of innovate in the U S.

Following prepared remarks, we will be conducting 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.

He used to be Brent events relate to our business plans to develop <unk> integrated platform DNA medicine, which include clinical and regulatory developments and timing of clinical data readouts, along with capital resources and strategic matters.

All of these statements are based on the beliefs and expectations of management as of today.

Actual events or results could differ materially.

We refer you to the documents we file from time to time with the SEC, which under the heading risk factors identify important factors that could cause actual results to differ materially from those expressed by the company verbally as well as statements made within this afternoon's press release.

This call is being webcast live on our website IR dot <unk> dot com.

And a replay will be made available shortly after this call's concluded now I'd like to turn the call over to <unk>, President and CEO Dr. Joseph Kim.

Thank you Ben and good afternoon, everyone.

I appreciate I appreciate your taking time to join US This afternoon.

Let me begin by stating how pleased I am with the progress that we've made over the last few months.

And I am grateful for the opportunity to share some additional context and discuss our efforts during this call.

The global community continues to deal with the impact of the COVID-19 pandemic.

And evolving variants of concern.

Global vaccination rates are approximately 50%, but rates are still below 5% in certain areas of the world.

Too many people are still without access a COVID-19 vaccine.

<unk> recognizes the important role we can play in supporting the global response to this public health crisis, and we remain focused on the continued need for safe and effective vaccines for both S primary vaccination series now.

And that's a booster vaccination.

We're excited that dosing for our innovate trial is underway.

And enrolment continues globally.

So at that point and just to recap we have received regulatory authorization to proceed and a total of seven countries to date, which includes Mexico, Brazil, The Philippines, Columbia, India, the United States, and Thailand with additional countries.

<unk> projected to follow.

Together, we are aiming to have the interim phase III efficacy data from this trial in the first half of 2022.

Pending clinical efficacy data.

Any plans to apply for emergency use authorization in respective countries.

Very quickly and just to further expand on Colombia.

In addition to receiving regulatory authorization to conduct a phase III trial in <unk>.

We also signed a non binding memorandum of understanding with Colombia's Ministry of health and social protection.

Reflecting our mutual intent to advance efforts to combat the continued threat posed by COVID-19, as well as to better prepare for future public health emergencies in Colombia.

The agreement creates a framework for collaboration under which <unk> and Columbia government can explore knowledge sharing.

Technology licensing and capacity building towards developing and producing vaccines, along with other biopharmaceutical and Columbia.

This morning, as you probably have read.

<unk> announced that the U S. FDA provided authorization to proceed for innovate phase III segment of our COVID-19 vaccine candidate INO 4800 in the U S.

<unk> now has the opportunity for the U S participants.

<unk> contribute.

Two enrollment in our innovate phase III segment.

The FDA has lifted the partial clinical hold following its review.

Of additional non clinical clinical and device information provided by <unk>.

As I stated in this morning's release.

I would like to recognize and express my appreciation to all of my colleagues for their hard work throughout this process.

Separate from our innovate phase III trial, the World Health organization shared on October 26 that INR 4800, that's one of the two vaccines two vaccine candidates to be initially included in the solidarity trial vaccines, which is.

As an international randomized controlled phase III efficacy trial sponsor funded and conducted by the <unk> show.

Further delineate show solidarity trial vaccines is designed to rapidly evaluate the efficacy and safety of promising new that new candidate vaccines selective by an independent vaccine.

Utilization Advisory group.

<unk> of leading scientists and experts.

They also shared that the trial has the additional potential to uncover second general second.

Generation vaccines with greater efficacy conferring greater protection against variants of concern.

Offering longer duration of protection and or using needle free routes of administration.

With uncertainty about future outbreaks and much of the global community still requiring greater access to vaccines.

We believe certain positive attributes of a DNA medicines platform like ours, and specifically iron ore for the 800.

<unk> public health measures against infectious diseases like COVID-19.

INR 4800 is well positioned to combat this global pandemic, having shown to be well tolerated to generate a balanced immune response that includes both cellular and tomorrow immune responses and.

And to offer a favorable thermal stability profile.

<unk> global distribution.

Additionally, <unk> partner a vaccine is sponsoring a booster study in China.

INR 4800 is given as a booster after primary vaccination with then inactivate COVID-19 vaccine.

Collectively these trials are a testament to the attributes of INR 4800, and this potential contribution globally.

A primary vaccine series and booster Queen.

<unk> for those who have received the primary series with other COVID-19 vaccines.

Given the impending endemic nature of the virus transmission that underlies this global health crisis.

And the need for boosters to ensure sustained protection.

DNA medicines may offer advantages compared to other approaches.

This quarter.

<unk> shared a positive data on homologous boosting from our phase one clinical trial as a pre print and met archive.

The paper, which Dr Anza mammen.

Will describe in further detail later in the call found that iron ore 4800 produced broad based immune responses and was well tolerated as both a two dose series.

And as a homologous booster.

Adults of all ages.

Separately from our COVID-19 program.

<unk> recently completed enrollment in our lassa fever vaccine trial, which is funded by <unk>.

Or the coalition for epidemic preparedness innovations.

These milestones collectively demonstrate the significant progress that <unk> continues to make.

Across our DNA medicines platform against infectious diseases.

With that I'd like to turn the call now to Dr. Anza Mammen, our SVP of clinical development for COVID-19 vaccine program Anza.

Thank you Joseph.

As Josef shared in his opening remarks, <unk> COVID-19 vaccine candidate INO 4800 is one of two vaccines. Currently included in the solidarity trial vaccine in phase.

Phase III trials sponsored and being conducted by the World Health organization.

Recruitment for the trial is already underway more.

More than 40 clinical sites have been identified to implement the trial in Colombia, Molly and the Philippines.

W drilled solidarity phase III efficacy trial is being conducted separately from <unk> global phase III efficacy segment of innovate.

As for innovate phase III.

We have now received regulatory authorization and a total of seven countries across the Americas and Asia Pacific.

Most recently the FDA has lifted the partial clinical hold on innovate great.

I'm, especially pleased to report that we recently received regulatory authorization to proceed in India.

This is a notable addition to the regulatory authorizations with feed from Brazil, Mexico, Colombia, Philippines and Thailand.

The impact of the pandemic on the Indian population and the persistent need for safe and effective vaccine.

We continue discussions with countries in Africa to provide us the greatest flexibility to enroll according to the ongoing medical need to change the epidemiology of Sars Colby <unk>.

The availability of vaccines in these countries.

As a reminder, innovate phase three is designed to evaluate the efficacy and safety of INR 4800, and a two dose regimen using the two milligram dose administered one month apart.

In a two to one randomization ratio of between <unk> 4800 and placebo.

Healthy men in Nonpregnant women at least 18 years of age are being enrolled with the primary endpoint of biologically confirmed COVID-19.

As Josef noted earlier and Novo recently shared phase one clinical data on homologous boosting of INO 4800 is a preprint in met archive.

The paper titled Sorry, Colby to DNA vaccine INO four to 800 induces durable immune responses capable of being boosted phase one open label trial.

Found that among the full phase one cohort of 120 participants.

<unk> 99, or 82, 5% of participants opted to receive a booster or third dose of INO 4800 in.

In the setting of available vaccine under emergency use authorization.

<unk> the tolerability of the vaccine.

The booster dose produce broad based immune responses and was well tolerated as both a two dose theory and thats a homologous booster dose in adults of all ages.

Notably we observed durable antibody response six months following the second dose and significantly increased antibody and T cell responses.

A homologous booster dose administered six to $10 five months following the second dose.

I don't know 4800 was well tolerated with no treatment related serious adverse events reported.

Most adverse events were local reactions that were mild in severity and did not an increase in frequency with age and subsequent dosing.

With that I will turn it back over to you Joe.

Thank you Anza.

As I mentioned during my opening remarks, we continue to be focused on advancing INR 4800.

Global innovate phase III trial with the goal to demonstrate I don't know 48 under its ability to prevent COVID-19, when given a primary two dose vaccination series.

I'll now ask <unk> senior Vice President of R&D, Dr. Kate Brodrick speak about little data efforts and our broader war and infectious diseases.

Thank you so much Joseph and Hello to everyone, who has joined US on the call today, it's a real pleasure to be here.

In parallel to our efforts advancing INO 400.

<unk> is also developing <unk>, which is our next generation Pan Covid vaccine candidate.

To combat content <unk>.

And potentially also serve as a boost for individuals previously immunized with wild type match vaccines.

We presented preclinical results on iron ore <unk> hundred and INR 42. During this year's week 2021 conference.

And our latest demonstrated consistency with.

<unk> platform wide safety and Tolerability profile. In addition to the ability to January Cte and CD four T cells as well as binding and neutralizing antibodies against Sars Covid two <unk>.

Data is available and people on Biotics under the title design and Immunogenicity of our pod.

Sars <unk> synthetic DNA vaccine.

Our COVID-19 program encompassing both our late stage advancement with iron ore <unk> hundred and our preclinical work with a INR 42.

Also in our deep experience and expertise in combating infectious diseases, and our dedication to supporting global public health.

And another update since the end of the third quarter, we announced full enrollment of our phase <unk> clinical trial for iron ore 4500, our DNA vaccine candidate for Lassa fever.

Our randomized blinded placebo control dose ranging study.

<unk> is being conducted at <unk>.

Morial Institute for medical research in Accra, Ghana.

<unk> is the first vaccine clinical trial for lassa fever ever to be conducted on the African continent.

The vital illnesses and dynamic.

There is currently no approved vaccine for the vital illness, which imparts an estimated 300000 people in the region annually and is responsible for 10% to 16% of hospital admissions and some parts of like beta Sierra Leone.

The W. H Shaw classifies lassa fever, I was one of the pathogen with epidemic potential to be Argentina addressed.

Thereby making the development of <unk> and <unk>.

The vaccine a global health priority.

We are extremely proud to reach this important milestone with many thanks to our partners for completing enrollment in this first ever clinical trial for our lassa fever on the African continent over the course of eight months during a global pandemic and with all the related travel restrictions.

The funding for this trial comes from Sappy, whose grant supporting the development of INR 4500 against lots of feedback as well as INR 4700, our DNA vaccine candidate from Mars.

And now I'll turn the call back to you Joseph Thank you.

Thank you Kay and now Dr. Jeffrey Skolnik.

Our senior Vice President of clinical development.

We will provide an update on our other important clinical programs Jeffrey.

Thank you very much Joseph.

As it relates to our HPV associated disease programs, we've completed follow up of our subjects reveal one the.

The first of two phase III pivotal studies evaluating <unk> 3100 for the treatment of cervical high grade squamous intra epithelia lesions caused by HPV 16, <unk> HPV 18 for <unk>.

Safety and durability of virological clearance for 18 months. Following the last administration, we expect to report our findings from reveal one later this year.

In addition, we're continuing our partnership with Qiagen to co develop a diagnostic tool to guide clinical decision, making for the use of <unk> 3100 in cervical <unk> and we look forward to sharing an update on our progress in the coming months.

Reveal two study is on track to complete enrollment of approximately 198 adult women with histologically confirmed cervical H still before the year end.

Regarding our immuno oncology efforts and Nokia on our partners continue to evaluate findings from our phase one two novel combination study of the DNA medicines, INR 50, 401, and INR 90, 12 in combination with the PD one checkpoint inhibitor <unk>.

Which is being jointly developed by Regeneron and Sanofi.

In treating newly diagnosed glioblastoma or GBM.

We look forward to sharing two year overall survival data, including correlative immunology and tissue data at a pre conference workshop of the society for immunotherapy of cancer or <unk>.

The 36th annual meeting and pre conference programs later this week with Dr. David <unk> will be presenting and discussing the study's latest findings. These will include overall survival at 24 months in both our MGMT promoter methylated and unmet related subject cohorts as.

Well as correlative immunology and tissue data and with that I'll turn the call back over to Joseph Thank you very much.

Yep. Thank you Geoffrey.

We continue to address difficult to treat cancers, such as GBM.

I want to reiterate my appreciation to our team.

Focused on immuno oncology and extend our thanks to regeneron for Terror continued collaboration.

We look forward to sharing further information that tsetse later this week.

I will turn the call over to Peter Keith our CFO for our third quarter financial summary theater.

Operator: our CFO for our third quarter financial summary. Peter.

Peter D. Kies: And good afternoon, everyone. We ended the third quarter with $394.9 million in cash, cash equivalents, and short-term investments. Our revenue for the third quarter of 2021 was $292,000, which compares to $236,000 for the same period in 2020. Our total operating expenses were $60.2 million, compared to $36.6 million for the same period in 2020. Inovio's net loss for the third quarter of 2021 was $60.2 million, or $0.29 per share, basic and dilutive, which compares to a net income of $19.2 million, or $0.12 per share basic and $0.11 per share dilutive, for the quarter ended September 30, 2020.

Thanks Joseph.

And good afternoon, everyone. We ended the third quarter with $394 9 million in cash cash equivalents and short term investments.

Our revenue for the third quarter of 2021 was 292000, which compares to 236000 for the same period in 2020.

Total operating expenses were $60 2 million compared to $36 6 million for the same period in 2020.

<unk> net loss for the third quarter of 2021 was $60 2 million or <unk> 29 per share basic and dilutive, which compares to a net income of.

Of $19 2 million or <unk> 12 per share basic and <unk> 11 per share dilutive for the quarter ended September 32020.

Peter D. Kies: Just as a reminder, net income for 2020, for the 2020 quarter was primarily due to a $35.3 million change in fair value of the derivative, Liability, related to the embedded conversion feature in our August 2019 convertible bond. The company also recorded a gain on investment in affiliate entities of $27 million.

Just as a reminder, net income for 2020.

For the 2020 quarter was primarily due to a $35 3 million change in fair value of the deliberate derivative lie.

Liability related to the embedded conversion feature in our August 2019 convertible bonds. The company also recorded a gain.

On investment and affiliated entities of $27 million. This was primarily related to the sale of its equity investment in <unk>.

Peter D. Kies: This was primarily related to the sale of its equity investment in GeneOne. Our R&D expenses were $47.1 million for the third quarter of 2021, which compares to $26.5 million for the same period in 2020. The increase in R&D expenses was primarily related to higher drug manufacturing, outside services, and clinical study expenses related to INO4800 and INO4802, and also employee and contractor compensation. This increase was also due to a decrease in the contra revenue and development expenses recorded from grant agreements of $2.4 million, among other variances.

Our R&D expenses were $47 1 million for the third quarter of 2021, which compares to $26 5 million for the same period in 2020.

The increase in R&D expenses was primarily related to higher drug manufacturing outside services and clinical study expenses related to INR 4800, and INR 42.

And also higher employee and contractor compensation.

This increase was also due to a decrease in the Contra revenue and development expenses recorded from grant agreements of $2 4 million among other variances.

Peter D. Kies: Lastly, G&A expenses were $13.2 million for the third quarter of 2021 versus $10.1 million for the same period in 2020. The increase in G&A expenses was primarily related to an increase in general and administrative expenses, which included non-cash stock-based compensation. This was partially offset by lower expenses from work performed related to corporate marketing and communications, among other variables.

Lastly, G&A expenses were $13 2 million for the third quarter of 2021 versus $10 1 million for the same period in 2020.

The increase in G&A expenses was primarily related to an increase in employee compensation, which included noncash stock based compensation.

This partial law. This partial this was partially offset by lower expenses.

From work performed related to corporate marketing and communications among other variances.

Peter D. Kies: And with that, I'll turn it back over to you, Joseph.

And with that I'll turn it back over to you Joseph.

Thank you Peter.

Joseph Kim: Before we take analyst questions, I want to take a moment to thank and recognize our trial participants, collaborators, and partners across our clinical program. Without their commitment, nothing would move forward. I also want to recognize and express my appreciation to the entire Inovio team for their unwavering efforts. Our organization's success results supporting the global response to COVID-19, as well as critical public health measures worldwide, reflect the continued urgency of this pandemic as well as the potential of Inovio's DNA medicines platform in combating other infectious diseases, cancers, and HPV-associated diseases.

Before we take analyst questions.

To take a moment to thank and recognize our trial participants collaborators and partners across our clinical programs.

Without their commitment and moving nothing moves for.

I also want to recognize and express my appreciation to the entire <unk> team for their unwavering efforts.

Our organization's steadfast resolve supporting the global response to COVID-19.

As far as critical public health measures worldwide.

Reflects the continued urgency of this pandemic as well as the potential of <unk> DNA medicines platform and combating other infectious diseases cancers and HPV associated diseases.

Joseph Kim: While we have achieved progress, we understand and accept that there is still much work to do. We remain focused, committed, and vigilant in our efforts. In closing, we are focused on delivering on the benefits of our DNA medicines platform. With four distinct global phase 3 trials for INO4800 and VGX3100, respectively, now underway, the Inovio team is committed and working tirelessly to fulfill the promise of DNA medicine. Our portfolio, as well as our efforts to expand the portfolio of available COVID-19 vaccines and become part of the global solution against COVID-19, underscore this commitment.

While we have achieved progress.

We understand and accept that there is still much work to do.

We remain focused committed and vigilant in our efforts.

In closing.

We are focused on delivering on the benefits of our DNA medicines platform.

With four distinct global phase III trials for INR, 4800, and <unk> 3100, respectively now underway.

<unk> team is committed and working tirelessly to fulfill the promise of DNA medicines.

Our portfolio as well as our efforts to expand the portfolio available COVID-19 vaccines.

And become part of global solution against COVID-19, underscores this commitment.

Operator: With that, let's open the call for questions. Operator? At this time, we will begin the question and answer session. To ask a question, you may press star, then 1 on your telephone keypad. If you are using a speakerphone, please take off your handset before pressing the keys. To withdraw your question, please press the star, then two. At this time, we will pause momentarily to assemble our office. Our first question comes from Jeff Meacham, Bank of America. Please go ahead.

With that let's open the call for questions operator.

Alex: Hi, thank you for taking our question. This is Alex on behalf of Jeff.

Alex: So, firstly, maybe to talk about how the lifting of the partial clinical hold for the Phase 3 study plays into your Phase 3 development plans, given that you were previously running that study primarily outside the United States. And then, secondly, what additional data do you provide to the FDA for review? You mentioned nonclinical, clinical, and device information. Thank you very much.

Joseph Kim: Yeah, thank you, Alex. So.

Joseph Kim: We really are not changing our strategy that much. You know, we have focused on a global strategy to go take our Innovate Phase 3 trial where there is a huge unmet need, the need for safe and effective vaccines in those countries, and the number of cases that exist in those countries. So that's why we're so excited to have received authorizations in countries like India, Thailand, Brazil, Colombia, Mexico, and the Philippines, as well as the U.S. What the clinical hold list and an actual Phase 3 authorization to proceed from the FDA mean is we can now add U.S. participants to this global trial.

It's a strategy that much you know we have focused on global strategy to to go take our interface phase three trial, where there is a huge unmet knee.

The need for safe and effective vaccines in those countries.

And the number of cases that exist in these country. So that's why we're so excited to have received authorizations in countries like India.

Island, Brazil, Colombia, Mexico, and the Philippines.

As well as the U S. What the what the clinical whole left then and an actual phase three authorization to proceed from the F. B. A means is we can now add the U S participants into this global trial and we look for.

Joseph Kim: And we look forward to adding U.S. participants based on feasibility and availability of those participants. The second part of your question: yes, we have provided all of the necessary clinical, preclinical, and device-related information that fully satisfied the FDA's reasons for the clinical hold. So we're very excited and pleased about that.

Four two adding U S participants based on feasibility and availability of those participants.

Second part of your question, Yes, we have provided all of the necessary clinical preclinical and device related information that's fully satisfied bsba's reasons for the clinical hole. So we're very excited and pleased about.

That.

Alright, thank you so much.

Alex: Great! Thank you so much.

Thanks.

Our next question comes from Hartong, very often harmer and comforted. Please <unk>.

Hartaj Singh: Our next question comes from Hartaj Singh of Oppenheimer & Company. Please go ahead.

Hartaj Singh: Great, thank you, and thanks for your time. One is just the data you presented with the patients and homologous boost data, you know, assuming you have a positive phase 3 and you go ahead with EUAs in various countries, Joseph, what will you need to file an additional EUA for a booster strategy also, you know, after your phase 3 for the initial vaccinations? And then number two, you know, your agreement with Columbia, you know, for example, companies like Vertex have used certain agreements as a framework to have, make other agreements with other countries all over the world. You know, is that the strategy that you're adopting with Columbia as sort of being a test case and then, you know, broadening that strategy to other countries? Thanks for the question.

Oh, great. Thank you and thanks for I got a couple of questions. One is just the the the data you presented with the patient August.

Used data you know assuming you have a positive phase three and go ahead with new ways of various countries. Joseph what did you need to file an additional EUA for a booster strategy also.

If you're a phase three for the for the initial vaccinations and then number two.

Your agreement you agreement with Colombia.

For example companies like vertex have used certain agreements.

As a framework to have make other agreements with other countries all over the world.

Is that the strategy that you adopted with Columbia sort of being a test case, and then broadening that strategy to other countries.

Thanks for the questions.

Yeah. Thank you <unk> I'm Gonna answer the second question first and then we will ask a doctor on some moment to address the first question.

Joseph Kim: Yeah, thank you, Hartaj. I'm going to answer the second question first, and I will ask Dr. Anza-Maman to address the first question for us.

For us, but yeah, Colombia is the first of I I believe many countries.

Joseph Kim: But yeah, Colombia is the first of, I believe, many countries that Inovio looks forward to doing either advanced market commitment contracts or other collaborative arrangements where we can share our technology or manufacturing capabilities and capacity. So, we really felt that Colombia's government had a positive and constructive outreach to us, and we reciprocated properly. So, I do think our relationship with Colombia can be an example to other countries. So, I agree 100% with your sentiments. Anza, would you like to address the first part of Hartaj's question?

<unk> it looks for two doing either advance market commitment contracts or other collaborative arrangements, where we can share our technology or manufacturing capabilities and capacity. So we really felt that.

Columbia Government had a positive and constructive outreach to US then we reciprocated properly. So I do think our relationship with Columbia can be an example, two other countries. So I I I do agree 100% on your sentiments.

And would you like to address the first part of Heartaches question.

Anza-Maman: Sure, absolutely. Thank you for the question. So just to summarize, in the phase one trial, we did evaluate a two-dose regimen of INO4800, followed by a homologous booster dose that was an optional booster, anywhere between six and ten and a half months after the second dose. And as I mentioned earlier, the safety and tolerability profile was quite favorable, and we were able to induce a broad-based immune response with the booster dose.

Sure absolutely. Thank you for the question. So just to summarize so in the phase one trial, we did evaluated two dose regimen Obrien O 4800, followed by homologous booster that was an optional booster.

Anywhere between six and 10 and a half months after the second dose and as I mentioned earlier, the safety and Tolerability profile was was quite favorable and we were able to induce a broad based immune response.

With with the booster dose now innovate phase three that will be evaluating I know 4800, and a two dose regimens. So subjects will be receiving two doses goodbye and Oh 4800, each administered one month apart.

Anza-Maman: Now, with Innovate Phase 3, we will be evaluating INO4800 in a two-dose regimen. So subjects will be receiving two doses of INO4800, each administered one month apart. However, once we are able to establish efficacy in that trial, then we may follow the subjects for a longer period of time, following their immune responses over time to further understand what the optimal timing for a booster might be. So that would be a homologous booster setting.

And.

Once we are able to establish epithets in that trial. Then we we may follow the subjects for a longer period of time uhm following they're immune responses overtime to to further understand what the optimal timing for a booster might be so that would be a.

Homologous booster setting now I should mention that AD vaccine our partners in China are concurrently evaluating I know 4800 has the potential heterologous boost and so they are uhm initiating a trial in the coming weeks that will evaluate subjects.

Anza-Maman: Now, I should mention that Advaxine, our partners in China, are concurrently evaluating INO4800 as a potential heterologous booster. And so they are initiating a trial in the coming weeks that will evaluate subjects who have received two doses of an inactivated vaccine followed by a boost with INO4800. So with these multiple clinical trials, we hope to further establish INO4800 as a viable booster, not only in a homologous setting but also as a heterologous setting following the primary vaccination series with other COVID-19.

Who have received two doses oven inactivated vaccine and followed by a boost with I know 4800. So so with these multiple clinical trials. We hope to further establish I know 4800 has a viable booster not only in a homologous setting.

But also as a heterologous city following the primary vaccination series with other COVID-19 vaccines.

Yep. Thank hopefully that covers your question.

Anza-Maman: Hopefully, that covers your question.

So.

I can add a little bit or touch two n's us a really good answer.

Joseph Kim: So if I can add a little bit, Hartaj, to Anja's really good answer. From a strategic point of view, we have realized for a while now that INO4800 could be a great vaccine with safety and hope to demonstrate efficacy in phase 3 or solidarity phase 3, or both. It's a great vaccine as a DNA vaccine, and we'll, it would provide attributes that are different than other approved vaccines there as a primary series.

From a strategic point of view, we realize or for awhile now I N O 4800 could be a great vaccine for S O.

With the safety and hope to demonstrate the efficacy and innovate phase three or solidarity phase three.

Or both.

Yeah.

<unk>.

It's a great vaccine as a DNA vaccine and what.

Would provide uhm attributes that are different than other approved vaccines there.

S. A primary series, but we also realized the changing landscape of the the need for for vaccines for booster is increasing and maybe even.

Joseph Kim: But we also realize the changing landscape of the need for vaccines for boosters is increasing, and maybe even the greater need, medical need, and market need. So we are looking at heterologous boost as an expansion of the utility of INO4800 against this global pandemic, but also looking forward to an endemic stage.

B grade or need medical need and and market knee.

So we are looking at heterologous boost that's expansion of the utility vinyl 4800 against this global pandemic, but also looking forward in a in that mix daych and as I touched on in my prepared remarks.

Joseph Kim: stage. And as I

Joseph Kim: And as I touched on in my prepared remarks, we think there's a huge advantage for INO4800 due to its safety and tolerability. And hopefully, we can demonstrate that in a heterologous boost setting, not just from the vaccine inactivated vaccine boosting setting, but for other future studies where we can demonstrate the boostability of INO4800. So, please stay tuned for more.

So you know we we think there's there there's a huge advantage for I N O 4800, due to safety and Tolerability.

And and hopefully we can demonstrate that in a heterologous blue setting not just from the vaccine in activate a vaccine boosting setting but for other future studies, where we can demonstrate the bush stability of I N O 4800. So please stay tuned for later.

Great. Thank you Joseph Joseph <unk>, I'm, sorry, one housekeeping matter D. I P issue seems to be flaring up again with vaccine manufacturers in the U S. Government. There is article to the New York Times I believe regarding Donna Uhm do you have any I P.

Hartaj Singh: Great. Thank you, Joseph. And Joseph, just one housekeeping matter, you know, the IP issue seems to be flaring up again with vaccine manufacturers in the US government. There's an article today in the New York Times, I believe, regarding Moderna. Do you have any IP, you know, that overlaps with the US government or any government entity?

That overlaps with the U S government or any government entity and again, thank you for all the questions.

Yeah. Thank you we have received T O. The funding on some of our device three P. S. B development, but IP belongs to <unk>. So we don't believe there is any overlap, but that's the thing that we as we were.

Joseph Kim: And again, thank you for all the Yeses. Thank you.

Joseph Kim: Yeah, thank you. We have received DOD funding for some of our 3PSP device development, but the IP belongs to Inovio, so we don't believe there is any overlap, but that's the thing that we, as we work with various governments, including the U.S. government, we want to be very careful with.

Work with the various governments, including the U S government, we want to be very careful with.

Great. Thank you.

Gregory Renza: Great, thank you. Our next question comes from Gregory Renza of RBC Capital. Please go ahead.

Oh sure I can come from Gregory around five or V. C capital Please get.

Yes, good afternoon, Joseph and team congrats on clinical hold lift in progress and thanks for taking my questions.

Gregory Renza: Yes, good afternoon, Joseph and team. Congratulations on the clinical lift in progress, and thanks for taking my questions. Thank you. Joseph, as you've guided towards potential interim efficacy data in the first half of 2022 for Innovate, I just wanted to ask you if you could provide some color on what the parameters would be there as far as biologically confirmed cases, the enrollment pace, or at least remind us of some of that as we think about when that could occur. And related to that, what needs to break, right within the environment, for you to reach your targets across enrollment countries?

Thank you Joseph as you've guided towards potential interim efficacy data in the first half of 2022 for it for him.

Innovative just wanted to ask you if you could provide some color on what the parameters would would be there as far as biological confirmed cases, the the enrollment.

Pace or at least remind us of some of that as we think about when that that could occur and related to that and what needs to break right just within the environment for you to to reach your targets across enrollment countries Ah certainly sounded like the the clinical whole lift.

Gregory Renza: I certainly sound like the clinical hold lift has been helpful. And then, just a second, perhaps related question. With the clinical hold lifted, I'm just curious if you could comment on how you think about the device needing to evolve in order to meet the evolving needs of the international market opportunity for you to deliver doses and 4,800 alongside the device to those patients that you talk about in need. Thank you very much. Yes,

Has been has been helpful. And then just a second perhaps related related question with the clinical hold to lift I'm. Just curious if you could comment on how you think about the device and needing to evolve in order to meet the evolving needs of of the Internet national market opportunity for you to deliver.

Doses and 4800 alongside the device to them to those patients that you talk about a need thank you very much.

Yeah. Thanks, Craig.

Joseph Kim: Yeah, thanks, Craig. A lot of really good questions.

I had a really good question, so I'll I'll try addressing it and if you need deeper answers I have folks anza, and Jackie and others that can help them yet I would just say the the devices are really important and obviously the partial hold was just in the.

Joseph Kim: So I'll try addressing it. And if you need deeper answers, I have folks like Anza and Jackie and others that can help me out. I would just say the devices are really important. And obviously, the partial hold was just in the U.S. So we really didn't have a material impact on opening countries and sites outside the U.S., as we've shown six other country openings for a trial in the last several weeks. But it really was the clinical hold lift and authorization for phase three in the U.S.

So we really didn't have a material impact in opening countries and sites outside the U S. S. We've shown six other country openings for a trial in the last several weeks, so but it really the the <unk>.

Cynical hold lift an authorization for phase three in the U S. It provides us additional validation and it it shows that we have met all of the the concerns of the U S. F D a satisfactorily.

Joseph Kim: It provides us additional validation, and it shows that we have met all of the concerns of the U.S. FDA satisfactorily. That being said, we're really pleased to say that the dosing for the innovate phase three trial has already begun and is underway. And interim efficacy, it's a case-driven study. So the magic number is around hundred and fifty lab confirmed cases. And, and, of course, interim will be in fifty percent of those cases.

That being said, we're we're really pleased that to say that the dosing for innovate phase three trial has already begun and is underway and interim efficacy. It's the case German studies. So magic number is around 150.

Lab confirmed cases in and of course interim will be at the 50% of those cases, so you know faster enroll N N and the the the the percent of attack right in those countries or deep those regions.

Joseph Kim: So, you know, faster enrollment and, and, and the percent of attack rate in those countries or those regions will really impact when exactly where we will meet that fifty percent efficacy. Read these are all blinded until we hit about seventy five cases. So that's why we left that as a broadly first half twenty, twenty two.

Really impact when exactly.

Where we will meet that 50% efficacy read these are all blinded until we hit about 75 cases. So that's why we left that as a broadly first half of 2022.

Joseph Kim: So that's what we're looking for. And it's always been the same design since when we started the Innovate Phase 3 trial. So our team is working really hard to open these sites, get approvals in the country's open sites and in rural subjects.

So.

So that's what we're looking for and it's always been the same design from when we started the the interface phase three trial. So no. Our team is working really hard to to open these sites.

Get approval and the countries open sites and enroll subjects separately. The solidarity trial is is upgrading independently.

Joseph Kim: Separately, the Solidarity trial is operating independently, and we're really grateful that the WHO has selected, or their independent panel has selected INO4800 as one of the initial vaccines, and I think there are two more being added in the future. But out of 20 or so candidates for second wave COVID-19 vaccines out there, we're highly grateful for that selection. Obviously, we think we are the leader of the second wave of COVID-19 vaccines, and we have the opportunity to demonstrate it.

And we're really grateful that the W. H O has selected.

Or they're independent panel has selected I N O 4800 S. One of two initial vaccines and I think there's two more being added in the future, but out of 20 or so candidates of second wave COVID-19, Xerxes out there. So we're <unk>.

Highly grateful for that selection. Obviously, we think we are the leader of the second wage COVID-19 vaccines.

And we have the opportunity to demonstrate or efficacy and safety I have no qualms about our safety, but we still have to get to that efficacy data and we have two shots on the goal with our innovate face do trial that we're conducting.

Joseph Kim: Our efficacy and safety, you know; I have no qualms about our safety, but we still have to get to that efficacy data. And we have two shots at the goal with our Innovate Phase II trial that we're conducting with our partner vaccine, as well as WHO's Solidarity trial. So, we couldn't be any happier or excited about our opportunities here, and our team is working really hard to achieve that. That's helpful, Joseph. Thank you again. Yes, Thank you, Greg. Our next question comes from Charles Duncan of Canter Fitzgerald. Excuse me, but please go ahead.

With our partner a vaccine as well as W. H OS solidarity trial, so what we couldn't be any happier or or excited in our opportunity Sir and our team is working really hard to achieve that.

That's helpful. Joseph Thank you again.

Yep. Thank you Greg.

Our next question comes in Charles Duncan or Cantor Fitzgerald excuse me. Please go.

Hi, Joseph this is not a piece of the rock was on for Charles.

Pete Stavropoulos: Hi Joseph, this is Pete Stavropoulos on behalf of Charles. Congratulations on all the progress made this quarter. One question is, you know, several months ago, India granted an emergency use authorization for a DNA-based COVID-19 vaccine. Can you tell us what you believe are the differentiating factors for ENO4800 when compared to Zycov-D and what advantages ENO4800 could provide?

Hey P. Congrats.

Congratulations on the all the progress made this quarter.

One one question is.

Several months ago, India granted an emergency use authorization for a DNA.

<unk> COVID-19 vaccine.

Can you tell us what you believe we're differentiating factors for you know 40, 801 compared to a cycle and what advantages could 4800 provide.

Yeah, you know you know I think India being a pioneering uhm regulatory.

Joseph Kim: Yeah, you know, I think India, being a pioneering regulatory agency, having the experience, having the know-how to measure and test and grant approval, emergency approval, for the Zytus DNA vaccine, I think it's a tremendous advantage for us to have the INO4800 INNOVATE trial conducted in India. And as Anza mentioned, there are many other reasons, you know, they have a huge population with a need for additional safe The difference between Zytus' DNA and Inovio's is delivery. We use in vivo electroporation, the Selectra system that we feel has been demonstrated to optimize the delivery of DNA plasmids. We've tested this in tens of thousands of administrations.

Regulatory agency.

Having the experience having the know how to measure and and tests, then and grant approval emergency approval for for the Zaidis is TNA vaccine I think it's a a tremendous advantage for us.

To have I N O 4800, and have a trial conducting in India, and that's and as I mentioned there are many other reasons you know they have a huge population with a need for additional safe and effective vaccine.

The difference between <unk> and you know <unk> delivery.

We use in the Evo electric operations Elektra system that we feel has been demonstrated to to optimize the delivery of DNA plasmas with tested this and tens of thousands of administrations. We've we've done a lot of.

Joseph Kim: We've done a lot of clinical and preclinical studies around that, so we think our intradermal delivery of INO4800 would give us a huge potential differentiating factor against Zytus' DNA, but it's also perhaps more advantageous to be the second in their regulatory process through India. So they have, you know, Indian sites have a familiarity with working with DNA vaccines, and I think there are other advantages for India. So we are very, very fortunate to have authorization in India, and we look forward to, you know, really having participants and data come out of India, as well as other parts of the world in Mexico, Colombia, the U.S., as well as Brazil and other places. But I think India, the reason why we highlighted India by ANZA is because of their experience with the previous DNA vaccine.

Nicole in preclinical studies around the so we thank our <unk> intradermal delivery of I N O 4800.

Would give us a huge potential differentiating factor two zaidis this DNA.

But it's it's also.

Perhaps more advantageous to be the second and their regulatory process through India. So they have.

India sites have familiarity of working with DNA vaccines, and and and I think there are other many of vantages for India. So we were very very fortunate to have authorization in India and we look forward.

Two two you know really having a participant send data come out of India S. Well, if other parts of the world in Mexico, Colombia U S as well as Brazil, and and other places so, but I I think India.

The reason why we highlighted India by onto is is their experience with the previous BNA vaccine.

[noise]. Thank you one more question could you provide an update on not you may 30 107 for Abby.

Pete Stavropoulos: Thank you, thank you. One more question: can you provide an update on ENO 3107 for RRP? Yes.

Yes.

Joseph Kim: Yes. Yeah, we have Jeffrey Skolnick here. I'm going to give a broad sort of update on our RFP immunotherapy currently being undergoing phase 1 slash 2 trials. Enrollment is continuing, and we hope to have both immune responses and early clinical benefit data potentially in the first half of 2022.

Yeah, we have Jeffery skolnick here, but I'm gonna give a broad sort.

Sort of update our our our P. Immunotherapy currently is undergoing <unk> one slash two.

Trial enrollment is continuing in.

And we hope to have both immune responses and early clinical benefit data potentially in the first half of 2022.

Pete Stavropoulos: Yep. Thank you. Congratulations again.

Aiden Horsonow: Our next question comes from Aiden Horsonow of Benchmark. Please go ahead.

Thank you.

Yep. Thank congratulations again.

Yeah. Thank you Pete.

Our next question comes from Aden Horsnell French Mark. Please go ahead.

Aiden Horsonow: Hi Joseph and the team for taking my questions. Hi Joseph, and congratulations on the progress this quarter, especially the announcement this morning about the ADA clearance.

[noise], Hi, Joseph and the team Hi, My question, Hi, Joseph and congratulations on the call. This this quarter, especially.

Aiden Horsonow: I have a couple of questions, but first I want to ask you about the WHO Solidarity Trial. So could you share with us the estimates of when we think we'll see the results from the Solidarity Trial? Will it be before the Innovate Readout or after the Innovate Readout? And also, could you give us some ideas about how the design of the trial is different from Innovate and how much of the overlap is in terms of the countries being enrolled in the trial?

The announcement this morning with the idea of Cleveland.

A couple of questions. So of course I wanted to ask you about the double which also without any trial. So.

If you could share without the U estimates of when do you think we will see the results from solar dollar the trial will it be before in a way three dolls or after three.

$3 and also if you could give us some ideas about how the design of the child is different for me no way then how much of the overlap he's in terms of the conscious being enrolled in the trial.

Yeah in terms of speaking around that there'll be a show trial you know, we we have to defer to their communications.

Joseph Kim: Yeah, in terms of speaking around the WHO trial, you know, we have to defer to their communication. But what I can tell you, and then I'll again turn to Anja, are the differences in the trial design. Um, but, uh, The overlaps, there are two countries that overlap within Innovate and Solidarity, and those are Colombia and the Philippines, but the actual sites do not overlap. So, you know, I think there's some synergies in that, but we don't expect there to be any conflict. Anza, would you like to touch on the differences in the overall design of the trial? Yes, sure, Joseph.

But what I can tell you in in again turn to answer.

But the differences in the trial design.

But the.

The the overlaps there's two countries that overlaps that within the innovate and solidarity and and those are Columbia in Philippines, but the actual sites do not overlap so.

There are some synergies and and and that but we.

We don't expect there to be any conflict and would you like to touch on the the differences in overall design of the trial.

Yes sure Joseph Thank you. Thank you for the question. So so all in all I would say that the designs are very similar between these phase three trial.

Anza: So, all in all, I would say that the designs are very similar between these phase three trials. INO4800 will be administered in a two-dose regimen with a two milligram dose, and each dose will be administered one month apart, and the surveillance period will begin 14 days after the second dose. In a very similar way, both trials will be collecting cases that are virologically confirmed.

I N O 4800 will be administered.

Two dose regimen.

Two milligram dose and each dose will be administered one month apart and the surveillance period will begin.

14 days after the second dose so in a very similar way both trials will be collecting cases that are biologically confirmed.

Anza: And I think in terms of the timing of getting the interim results, that's largely going to be dictated by the force of infection, as well as the rate at which each of these trials enrolls. So it's really, I think, probably not, I don't think we can really project at this point which trial will provide the interim efficacy data first. But we're really trying, hoping that both of these trials will be successful.

And I think in terms of the timing of getting the results uhm, that's largely going to be dictated by the force of infection as well as the rate in which.

Each of these trials will enroll.

So it's really I think probably not.

I don't think we can really projected this point, which trial will provide the interim efficacy data first, but where where hope we're really try and hoping that both of these trials will be able to enroll.

Anza: [inaudible]

Enroll efficiently.

Anza: We have, I think, both selected countries where there remains an unmet medical need, the vaccination rates are still relatively low, and the force of infection remains quite impressive. And so, I think both trials are well positioned to accrue cases. But again, the rate at which we are able to accrue the cases remains to be seen. So, I think at this point, you know, it's our projection, or our target, that we'll be able to do our interim analysis within the first half of next year. I'm not really able to comment on the timing with regard to the WHO trial. I'd rather defer that you ask those questions to WHO. Yeah, thank you.

We have I do both.

Selected countries, where in there remains an unmet medical need that the vaccination rates are still relatively low and the force of infection remains quite impressive and so I think both trials or or what.

Oh position to accrue uhm, the cases, but again the rate with which we are able to accrue. The cases I think remains to be see uhm. So I think at this point in our projections that or or target that we'll be able to do our interim analysis uhm what's.

In the first half of next year I'm.

I'm not really able to comment on the timing with regards to the WTO solitaire I'd rather prefer that you.

Those questions, we posed to Tokyo Joe.

Yeah. Thank you on over and you know I wouldn't say isn't that.

Joseph Kim: And, and, you know, I would say that our team is focused on enrolling Innovate as rapidly as possible and also providing support to WHO for their solidarity. But they're driving that trial, and I'm sure the efficiency and productivity are very good with the WHO. So we look forward to having both sets of data as soon as they become available.

It's.

Our team is focused on.

On enrolling in Nevada as rapidly as possible.

And also providing the support and two there'll be a chore for for that our solidarity, but they're driving that trial and I'm sure. The efficiency and productivity is is very good with the the bho. So we look forward to so having both sets of.

Data you know as soon as they become available.

Okay. Thank you.

Aiden Horsonow: Okay, thank you. This is very helpful.

So cool and another question I have is duration of protection. So right now with all the vaccines on the market. It seems that we need to have boosters every six to 12 months after the second dose.

Aiden Horsonow: And another question I have is on duration of protection. So right now, with all the vaccines on the market, it seems that we need to have boosters every six to 12 months after the second dose. I think you mentioned the longer duration of protection for INR 4800. So I wanted to ask how much longer do you think this protection is expected to be and whether this is based on presumed cellular immunity involvement? Thank you. Yeah.

You mentioned the longer duration of protection for I know all 40 content. So I wanted to ask how much longer do you think this protection is expected to be and whether this is based on presumed settled him immunity enrollment. Thank you.

Yeah, I'll I'll I'll take that yes, you know the benefits of having peace so responses along with the antibody responses.

Joseph Kim: Yeah, I'll take that. Yes, you know, the benefits of having T cell responses along with the antibody responses with INO4800 should provide longer potential protection, but, of course, we have to demonstrate that in clinical trial settings. So we look forward to gathering those data in the phase three trials. And, of course, from our preprint in MedArchive, we have seen antibodies persist through the six months period, and then we're boostable with our homologous boost.

Within Oh 4800.

We believe should provide a longer potential protection, but of course, we have to demonstrate that in clinical trial setting. So we'll look forward to gathering those data in the phase three trials and.

Of course from our Preprint Inmet archive.

We have seen antibodies persist.

Through the six months period.

And then <unk> boost of all with our homologous so strictly speaking of the clinical data. We think the so we're very excited about the potential of push stability vinyl 4800.

Joseph Kim: So, strictly speaking of the clinical data, we think that we're very excited about the potential of boostability of INO4800. But, you know, we'll, we'll, we'll follow the immune responses to determine the durability of the immune responses and also gather data for durability of protection in the future readout.

But we'll we'll we'll follow the immune responses.

Determined the durability of the immune response and also gathered the data for for a dual ability of protection in the in the future Rita.

Alright, Thanks, so very helpful and Joseph Congratulations with the progress underscore thank you.

Aiden Horsonow: All right. Thank you. Very helpful, Joseph. Congratulations on the progress made this quarter. Thank you.

Alright, Flushing come from your Chin, that's H C Wainwright pretty Scott.

Yi Chen: The next question comes from Yi Chen of HC Wainwright. Please go ahead. Thank you for taking my questions. Hi Joseph.

[noise]. Thank you for taking my questions.

Hi, Joseph hang up.

Yi Chen: Could you talk about your expectations for the...

Could you talk about your expectations for the 18 months date of read for the review one trial versus the I'll tell you. The previously reported for 36 weeks.

Yi Chen: for the 18-month data readout for the Review 1 trial versus the data previously reported for 36 weeks.

Yeah, well I like to ask a doctor Jeffrey Skolnick suggests that the broadly of these question.

Joseph Kim: Yeah. Well, I'd like to ask Dr. Jeffrey Skolnick to address that broadly among these questions.

Jeffrey Skolnick: Sure. Thanks, Joseph, and thanks, Yi, for the question. So, you know, as you know, we shared earlier this year that in our first of the phase three pivotal studies, the REVEAL-1 study, we were able to show a statistically significant difference between women with cervical H-cell who had received VGX3100 versus those who had received placebo with respect to both histological clearance and viral clearance at that week 36 time point, and again, as you know, that's the primary endpoint of So, we met that.

Sure. Thanks, Joseph actually for the question. So as you know we.

We shared earlier this year that from our first of the phase three pivotal studying to reveal one study we were able to show a statistically significant difference between women with cervical H. So who had received vegf's 3100 versus those who had received placebo with respect to both.

Trickle clearance and a firewall clearance as well at that week 36 time points and again as you know and that's the primary endpoint of this study. So we met that we also met many of the secondary objectives and you know again had previously shared this really the.

Jeffrey Skolnick: We also met many of the secondary objectives and, you know, again, we had previously shared this. Really, the week 88 data was meant to give us confidence around the durability of the immune response and potentially to demonstrate whether or not there's still a virus. I will note that we've previously demonstrated that we have shown durability in our phase 2B study. So, you may be aware that we previously published on those data demonstrating up to 18-month durability in both regression clearance and, importantly, again, absence of virus in the cervix at that 88 time point. So we don't anticipate essentially any surprises. We really expect to see what we have already shown in a randomized study. And again, that would be related to the durability of the response and also immunogenesis.

Week 88 data is meant to give us confidence around the durability of the immune response Patel.

Potentially to demonstrate whether or not they're still virus I will note that we previously demonstrated that we have shown durability and our faith to be study. So you may be aware that we previously published on those data.

<unk> up to 18 months durability in both the regression clearance.

And importantly, again, an absence of virus in the cervix at that 88 times.

So we don't anticipate essentially any surprises really expect to see what we have already shown in a randomized study and again that would be related to the durability of spots and also immunogenicity.

Got it thank you.

Yi Chen: Thank you. And regarding the Phase 1-2 trial of 5401 for newly diagnosed GBM, the 24-month data is coming out soon.

And regarding the first one to 12 O 2414, you wanted that sounds <unk>.

24 months data is coming out soon so can talk about what are the potential next steps after that.

Yi Chen: Okay, talk about what the potential next steps after that are.

Sure just would you like me to yeah happy to answer that so.

Yeah, happy to answer that. So, you know, we're very pleased that, as you say, we'll be able to present our data later this week at the pre-conference symposium at the CITSEA meeting, where Dave Reardon and

We're very pleased to as you say it being able to present our data later this week at the the pre conference symposium at the <unk> meeting, where Dave Reardon and.