Q4 2019 Earnings Call

Operator: Welcome to the Inovio Fourth Quarter 2019 Financial Results Conference Call. All participants will be in listen-only mode.

Okay and welcome to the you know Innovo fourth quarter 2019 financial results Conference call. All participants will be in listen only mode should you need assistance. Please signal conference specialist by pressing the star key followed by zero. After today's presentation, there will be an opportunity to ask questions to ask a question you May Press Star then one.

Operator: Should you need assistance, please signal a conference specialist by pressing the star key followed by zero. After today's presentation, there will be an opportunity to ask questions. To ask a question, you may press star, then one on your touchtone phone. To withdraw your question, please press star, then two.

On on your Touchtone phone to withdraw your question. Please press Star then too.

Operator: Please note this event is being recorded. I would now like to turn the conference over to Ben Matone, Senior Director of Investor Relations. Please go ahead.

Please note. This event is being recorded I would now like to turn the conference over to Ben Midtown Senior Director of Investor Relations. Please go ahead.

Ben Matone: Thank you, operator. Good afternoon, and thank you for joining the Inovio Pharmaceuticals fourth quarter and year-end 2019 investor conference call. With me today are Inovio's President and CEO, Dr. Jay Joseph Kim, our Chief Financial Officer, Mr. Peter Kies, and Senior VP of Research and Development, Dr. Kate Brodwick, who will provide an overview of Inovio's continued efforts regarding the company's DNA vaccine which is targeting the current COVID-19 outbreak. Today's call is being webcast live on our website, ir.inovio.com, Following a general business update, we will conduct a question and answer segment, which will be reserved for equity research analysts. During this call, we will be making forward-looking statements that relate to our business, which include our plans to develop Inovio's integrated platform of DNA medicines, as well as clinical and regulatory developments and timing of clinical data readouts, along with our capital resources.

Thank you operator good afternoon. Thank you for joining the Inovio pharmaceuticals fourth quarter and year end 2019, Investor Conference call with me today, our Inovios, President and CEO dR.J., Joseph Kim Our Chief Financial Officer, Mr., Peter Keith and senior VP of research and development Dr. Cape Broadway.

And an overview on Inovios continued efforts regarding the company's DNA vaccine, which is targeting the current coded 19 outbreak.

Today's call is being webcast live on our website IR dot inovio dot com and a replay of todays call will be made available.

Following a general business update we will conduct a question and answer segment, which will be reserve for equity research analysts.

During this call we will be making forward looking statements that relate to our business, which include our plans to develop inovios integrated platform of DNA medicines, as well as clinical and regulatory developments and timing of clinical data readouts, along with our capital resources.

Ben Matone: All these statements are based on the beliefs and expectations of management as of today. These statements involve certain assumptions, risk, and uncertainties, and could cause actual results to differ materially. We assume no obligation to revise or update forward-looking statements, whether as a result of new information, future events, or otherwise. Investors should read carefully the risks and uncertainties described in today's press release as well as the risk factors included in today's 10k filing with the SEC. I would now like to turn the call over to Inovio's President and CEO, Dr. J. Joseph Kim.

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

These statements involve certain assumptions risks and uncertainties and could cause actual results to differ materially.

We assume no obligation to revise or update forward looking statements, whether as a result of new information future events or otherwise.

Investors should read carefully the risks and uncertainties described in today's press release as well as the risk factors included in today's 10-K filing with the SEC.

I'd now like to turn the call over to Inovios, President and CEO dR.J. Joseph Kim.

Dr. J. Joseph Kim: Thank you, Ben, and good afternoon, everyone. It seems much longer than two months ago when we provided our clinical program update announcement in January. We have accomplished much in the last two months, even in the midst of all that has emerged and continues to evolve with the coronavirus. Back in January, we remarked that this year was setting up to be a transformational period for Inovio. And wow, investor attention over the last couple of months has been on our COVID-19 vaccine development. This call is timely, as I think it allows us to reconnect investors to our core fundamentals and Pipeline Programs, an exciting upcoming beta catalyst. But before the update on our core pipeline programs and our upcoming catalysts, I would like to address the emerging novel coronavirus pandemic and give an overview of our COVID-19 vaccine development. I'd like to introduce our Senior VP of R&D and our COVID-19 team lead, Dr. Kate Broderick. Kate?

Thank you Ben and good afternoon, everyone.

It seems much longer than two months ago. When we provided our clinical program update announcement in January.

We have accomplish much in the last few months even in the midst of all of that has in March and continues to evolve with the Corona virus.

Back in January we remark that this year is setting up could be a transformed transformational period for inovio.

And while investor attention over the last couple of months has been on our Covidien 19 vaccine development.

This call as timely as I think it allows us to reconnect investors to our core fundamentals and pipeline programs and exciting upcoming data catalyst.

Before the update on our core pipeline programs and our upcoming catalysts.

I would like to address the emerging novel Corona virus epidemic.

An overview of our Covance 19 vaccine development.

I'd like to introduce our senior VP of R&D, and our Cobot 19 team lead Dr. Kate Broderick Kate.

Dr. Kate Broderick: Thank you, Joseph, and good afternoon, everybody. Yesterday, March 11th, according to the WHO, approximately 118,000 cases of COVID-19 were reported globally, with more than 4,292 deaths. The CDC has reported a total of 938 cases in the U.S., with 29 total deaths. This alarming situation is rapidly evolving and requires a swift, collective response from biotech and pharma companies around the world. During our time together today, I'd like to cover three main points.

Okay.

Thank you Jill Seth and good afternoon everybody.

Yesterday March 11, according to the W. equal approximately 118000 cases of coal with 19 has been reported globally with more than 4292 day.

The CDC as reported a total of 938 cases in the U.S. with 29 total day.

This alarming situation is rapidly evolving and requires a swift collective response from biotech and pharma companies around the world.

During our time together today I'd like to cover three main points.

Dr. Kate Broderick: Number one, why Inovio may have one of the best platforms to respond to emerging infectious diseases. Number two, Inovio's progress to date in developing INO4800, our vaccine against COVID-19. And lastly, point number three, our next steps and anticipated milestones. So far.

Number one.

Why Inovio may have one of the best platforms to respond to emerging infectious diseases.

Number two I know vehicles progress to date developing I know for.

4100, our vaccine against Coolfit 19.

Lastly point number three our next steps unanticipated milestones.

So far.

Dr. Kate Broderick: Why is Inovio optimally suited to rapidly respond to emerging infectious diseases like COVID-19? Well, we have consistently demonstrated potent CD8 killer T-cell and antibody responses in all of our previous immunotherapy and vaccine clinical trials. In fact, Inovio has extensive experience working with coronaviruses, specifically with MERS, or Middle Eastern Respiratory Syndrome.

Why isn't it will view all optimally assisted to rapidly respond to emerging infectious diseases like Qubec 19.

Well, we have consistently demonstrated potent cdeight killer T cell an antibody responses from all of our previous immunotherapy and vaccine clinical trials.

In fact, Inovio has extensive experience working with could ONIVYDE assessed.

Specifically with my first our middle Eastern responded very central.

In fact, Inovio is the only company with a vaccine candidate against Mars in a phase two a clinical trial.

Dr. Kate Broderick: In fact, Inovio is the only company with a vaccine candidate against MERS in a Phase 2a clinical trial. We are leveraging our experience with the MERS coronavirus and applying it here to COVID-19 with support from the same organization, CEPI, who is funding our larger phase two MERS trial in the Middle East. In addition, Inovio's DNA medicines are stable at room temperature for over a year and at 2 to 8 degrees for more than three years. When you contrast that to other vaccine approaches, like recombinant proteins, viral vectors, and messenger RNA after the LNP formulation step, these must be kept at minus 80 degrees.

We are leveraging our experience with Mars Corona Vitesse on applying it here to covert 19 with support from the same organization Sappy, who is funding our larger phase two bars trial in the middle East.

In addition, Inovios DNA medicines are stable at room temperature foot over the year.

That 2008 degrees for more than three years.

When you contrast that to other vaccine approaches like recombinant proteins vital vectors on messenger out a knee after the LMP formulation step these must be kept at minus 80 degrees.

Perhaps most importantly, our de any medicines have demonstrated an acceptable safety profile and over 2000 patients.

So let's move on to Inovios, Coolfit 19 vaccine development progress to date.

On December 31st to size 19, Inovio scientists learned about a novel Corona Vitesse named far Cooley too, which caused an outbreak of responded to the disease and will have on China.

Dr. Kate Broderick: Perhaps more importantly, our DNA medicines have demonstrated an acceptable safety profile in over 2,000 patients. So let's move on to Inovio's progress with the COVID-19 vaccine development to date. On December 31st, 2019, Inovio scientists learned about a novel coronavirus named SARS-CoV-2, which caused an outbreak of respiratory disease in Wuhan, China. Shortly thereafter, on January 10th, 2020, Chinese researchers shared the genetic sequence of the novel coronavirus. Using this information, we designed a DNA vaccine, INO4800, in three hours. So how were we able to do this so quickly? While DNA vaccines do not require the possession of the virus to make a vaccine, we just need the viral gene sequence, and then we employ our proprietary algorithm to design a DNA vaccine.

Shortly thereafter on John Eudy, 10, Twentytwenty Chinese researcher shared the genetic sequence of the novel Corona Vitesse.

Using this information we designed to DNA vaccine I know 40 103 hours.

So how are we able to do the so quickly.

While DNA vaccines do not require the possession of the virus to make a vaccine we just need the vital gene sequence on them, we employ our proprietary algorithm to design a DNA vaccine.

In addition, our deep understanding an expertise and couldn't have itis vaccine development from our previous an ongoing work with at least at Corona Vitesse that causes Lars allowed us to be able to move very quickly.

And the second half of John Eudy on into February we began small scale manufacturing of the vaccine.

And completed the first phase of preclinical testing.

Im pleased to see that we saw the expected type of immune responses in these studies.

Robust preclinical data has been shared with our public and private partners on is currently in consideration for publication in the peer reviewed scientific journal.

Dr. Kate Broderick: In addition, our deep understanding and expertise in coronavirus vaccine development from our previous and ongoing work with the related coronavirus that causes MERS allowed us to be able to move very quickly. In the second half of January and into February, we began small-scale manufacturing of the vaccine and completed the first phase of preclinical testing. I'm pleased to say that we saw the expected type of immune responses in these studies.

And I can assure you the our dedicated research team on our global collaborators are generating even more preclinical data as we speak.

In addition, I know 4100 is the 16th problem.

Is the 16th product to enter the clinic using our DNA medicines platform.

We are able to leverage this extensive clinical and regulate to the experience and expertise to rapidly advance. This vaccine entered the clinic.

My first one final point is related to future Stetson milestones.

Our goal is to begin human clinical trials and the U.S. and April.

Dr. Kate Broderick: Robust preclinical data has been shared with our public and private partners and is currently under consideration for publication in a peer-reviewed scientific journal, and I can assure you that our dedicated research team and our global collaborators are generating even more preclinical data as we speak. In addition, INO4800 is the 16th product to enter the clinic using our DNAmedicines platform. My third and final point is related to future steps and milestones.

We're also planning to begin human clinical trial soon thereafter, with our clinical partner on vaccine in China on potentially in South Korea with additional collaborators in funders.

Contingent upon partner positive data on public urgency and funding we are capable of delivering 1 million doses of iron ore 4800 by year end based on our existing resources on capacity.

As Josef mentioned during his quite highs meeting with the U.S. could Luna virus task force, we will need additional resources to scale up and make enough doses to help protect the American public from Coolfit 19, as wells to contribute to the collective global efforts to curtail this bias.

And we'll be able with committed to leading the fight against this global pandemic and we look forward to updating you on our progress in the near future.

Dr. Kate Broderick: Our goal is to begin human clinical trials in the U.S. in April. We are also planning to begin human clinical trials soon thereafter with our clinical partner AbVaccine in China and potentially in South Korea with additional collaborators and funders. Contingent upon positive data and public urgency and funding, we are capable of delivering one million doses of INO4800 by year end, based on our existing resources and capacity. However, as Joseph mentioned during his White House meeting with the U.S. Coronavirus Task Force, we will need additional resources to scale up and make enough doses to help protect the American public from COVID-19, as well as to contribute to the collective global efforts to curtail this

Lastly, as you've probably seen and are released this morning, we announced a new $5 million dropped from the Bill and Melinda Gates Foundation to accelerate the testing and scale up of the Selectra Threepi SP proprietary smart device for the intradermal delivery of.

Hi annual 4100.

Our initial development of Selectra three PSP was started in 2019 with an 8.1 million dollar funding support from the medical arm of the US Defense Brett consortium.

Collectively these grants will support continued development of our intradermal delivery smart devices, which are essential for our vaccine disease.

Platform.

This latest crap comes in addition to the funding that we received from Seppi earlier in the year of $9 million, which clearly funds the development of iron ore.

Dr. Kate Broderick: Inovio is committed to leading the fight against this global pandemic, and we look forward to updating you on our progress in the near future. Lastly, as you may have probably seen in our release this morning, we announced a new $5 million grant from the Bill & Melinda Gates Foundation to accelerate the testing and scale up of the Selectra 3PSP proprietary smart device for the intradermal delivery of INO4800. Initial development of Selectra 3 PSP was started in 2019 with $8.1 million in funding support from the medical arm of the U.S. Defense Threat Consortium. Collectively, these grants will support continued development of our intradermal delivery smart devices, which are essential for our vaccine disease platform. This latest grant comes in addition to the funding that we received from CEPI earlier in the year for $9 million, which fully funds the development of I&O 4800 through U.S.

4800 through U.S. phase one clinical testing.

Altogether. These grants convey the continued confidence on support and Adobe technology and platforms with the ability to address both are just pandemics, such as cool that 19, as well as potential future ones.

We sincerely appreciate our partner support on these endeavors and we look forward to shading more with you in the coming months.

With that I'd like to turn it back to usual Sir Thank you.

Thank you Kate.

We really appreciate all the work that you and your team are doing I can tell you from my recent interactions with President Trump.

And the Corona virus test for US there are looking to inovio as one of the leaders to address this ongoing public health threat and cooperate with other companies on organizations on this important effort as a part of the covered 19 vaccine community.

Given our Inovio team continues to be a vital part of this development working around the clock tours getting a vaccine into humans as quickly and safely as possible.

Dr. J. Joseph Kim: Phase I clinical testing. Altogether, these grants convey the continued confidence and support in Inovio's technology and platforms, with the ability to address both urgent pandemics, such as COVID-19, as well as potential future ones. We sincerely appreciate our partner support on these endeavors, and we look forward to sharing more with you in the coming months.

We can thank everyone enough and inovio.

This has truly been a team effort.

With that let's continue on our core pipeline program updates.

First our new product candidate I know 31 off seven.

In February of this share we received I and the acceptance for a phase one slash two trial to evaluate iron ore 30 107.

Our DNA immunotherapy for treating recurrent.

Respiratory papilloma ptosis or RFP.

Dr. J. Joseph Kim: Thank you, Kate. We really appreciate all the work that you and your team are doing. I can tell you from my recent interactions with President Trump and the Coronavirus Task Force, they are looking to Inovio as one of the leaders to address this ongoing public health threat and cooperate with other companies and organizations on this important effort as a part of the COVID-19 vaccine community. You and our Inovio team continue to be a vital part of this development, working around the clock toward getting a vaccine into humans as quickly and safely as possible. We can't thank everyone enough at Inovio. This has truly been a team effort.

RP is a rare disease caused by HPV type six and 11 infections.

This conditioning causes noncancerous tumor gross.

Leading to life, threatening airway obstructions and occasionally can progress to cancer.

Currently the diseases in curable and is mostly should about invasive surgery.

Which temporarily reduced restores the airway.

However, the tumor almost always recurs.

And the surgery must be repeated often multiple times a year.

You can imagine how RFP severely impacts the quality of life for those living with the disease.

And 31, a seven is designed to this drawing clear tumors caused by HPV, six and 11 infections.

It has the potential to provide people living with RP, a long term improvement in their disease.

Dr. J. Joseph Kim: With that, let's continue with our core pipeline program update. First, our new product candidate, INO3107. In February of this year, we received IND acceptance for a Phase 1-2 trial to evaluate INO3107, or DNA immunotherapy, for treating recurrent respiratory papillomatosis, or RRP. RRP is a rare disease caused by HPV type 6 and 11 infections. This condition causes non-cancerous tumor growth, leading to life-threatening airway obstructions and occasionally can progress to cancer. Currently, the disease is incurable and is mostly treated by invasive surgery, which temporarily restores the airway. However, the tumor almost always recurs, and the surgery must be repeated, often multiple times a year. You can imagine how RRP severely impacts the quality of life for those living with the disease.

Especially as an alternative to often frequent and the ability ratings surgeries that do not addressed the underlying disease, causing virus.

We first saw annual 30, 31 or sevens potential.

And results from a pilot study of two RFP patients with HPV six infection.

Which were published in the peer reviewed scientific journal vaccines recently.

For injections of immunotherapy allowed to two RP patients to delay the need for surgery to have robust degree.

Both had previously required to surgeries per year. So.

To manage this disease, but after dosing with our immunotherapy, one patient was able to delay surgery for over a year and a half and the second.

Has remained surgery free for almost three years.

The multi center phase one flush through trial.

Well evaluate the efficacy safety Tolerability and Immunogenicity of Iron ore 31 of seven and approximately 63 adult patients with HPV, six and or 11 associated RFP, who have require at least to serve.

Nicole interventions per year for the past three years.

Dr. J. Joseph Kim: IONO 3107 is designed to destroy and clear tumors caused by HPV6N11 infections. It has the potential to provide people living with RP a long-term improvement in their disease, especially as an alternative to often frequent and debilitating surgeries that do not address the underlying disease-causing virus. We first saw IONO 3107's potential and results from a pilot study of two RRP patients with HPV6 infection, which were published in the peer-reviewed scientific journal Vaccines recently. Poor injections of immunotherapy allowed 2 out of 2 RP patients to delay the need for surgery to a robust degree. Both had previously required two surgeries per year to manage this disease, but after dosing with our immunotherapy, one patient was able to delay surgery for over a year and a half. And the second patient has remained surgery-free for almost three years.

The subjects well first undergo surgical removal of their papilloma and then received four doses of iron ore 30, Onest seven one every three weeks.

The primary efficacy endpoint.

We'll be a doubling or more in the time between surgical interventions. Following the first dose of iron ore 31, or seven relative to the frequency prior to study therapy.

In addition to initiating this efficacy trial.

Inovio also plans to apply for orphan disease designation with the FDA office of orphan products development.

This very exciting opportunity for Inovio adds to the growing body of evidence that Inovios DNA medicines drive clinical efficacy in multiple HPV related diseases.

We have already demonstrated clinical efficacy in three separate clinical indications.

First in cervical pre cancers with Midrex 3100.

Also in head and neck cancer with many zero for fast seven.

And now in a challenging respiratory tumor was iron ore 31 off seven.

Our goal remains to be the go to immunotherapy provider to effectively treat all major HPV related pre cancers and cancers and I think we are on our way there.

Dr. J. Joseph Kim: The Multi-Center Phase 1-2 trial will evaluate the efficacy, safety, tolerability, and immunogenicity of INO3107 in approximately 63 adult patients with HPV-6 and or 11 associated RRP who have required at least two surgical interventions per year for the past three years. The subjects will first undergo surgical removal of their papillomas and then receive four doses of INO3107, one every three weeks. The Primary Efficacy Endpoint will be a doubling or more in the time between surgical interventions following the first dose of INO3107 relative to the frequency prior to study therapy. In addition to initiating this efficacy trial, Inovio also plans to apply for Orphan Disease Designation with the FDA's Office of Orphan Products Development.

Now so our phase three program and lead asset Pgx 3100.

Our phase three reveal to trial for cervical eight so continues to enroll patients and that as a total of 43 sites open globally for recruitment.

Including new sites open in Brazil, and South Africa, along with four new use space sites.

Also topline efficacy data from reveal one phase three trial is on track to be reported in the fourth quarter of Twentytwenty.

We're also evaluating VGX 30, 102 separate phase two trials for the treatment of evolve our eight so.

On April eight so.

Preliminary efficacy and safety data our plan to be provider later this month at the American Society for composites copy and cervical puts us well Gee core EPS CCP 2020, scientific meeting on annual general and HPV related diseases.

Now turning to immuno oncology and our exciting progress on I know 54, one for treating glioblastoma.

Dr. J. Joseph Kim: This very exciting opportunity for Inovio adds to the growing body of evidence that Inovio's DNA medicines drive clinical efficacy in multiple HPV-related diseases. We have already demonstrated clinical efficacy in three separate clinical indications. First in cervical precancers with VGX 3100, also in head and neck cancer with MEDI 0457, and now in a challenging respiratory tumor with INO3107. Our goal remains to be the go-to immunotherapy provider to effectively treat all major HPV-related pre-cancers and cancers, and I think we are on our way there. Now, to our Phase 3 program and lead asset, PGX 3100.

In November of last year.

Inovio reported positive interim data on our phase two trial evaluating iron ore 54, one for terrific treating newly diagnosed GBM at S&P see 2019 annual meeting.

I don't know 54, one is a t. so activating DNA immunotherapy in quoting for three tumor specific antigens h. turret WT, one and PSN may.

And combines iron ore 90 to one of.

Our immune activator encoding interleukin 12.

We're also evaluating these combinations with lips tayo.

A PD one blocking antibody produced by Regeneron pharmaceuticals in collaboration with Sanofi.

Key early interim data from the 52 patient trial showed that 80% of MGMT gene promoter methylated patients and 75% of MGMT unmethylated patients or progression free at.

Six months.

Measure from the time of their first dose.

This substantially exceeded historical standard of care data of up approximately 60% for MGMT promoter methylated patients and about 40% for Unmethylated patients again, just to reiterate that was 80% versus 60 per.

Dr. J. Joseph Kim: Our Phase 3 Reveal 2 trial for cervical H-cell continues to enroll patients and now has a total of 43 sites open globally for recruitment, including new sites opened in Brazil and South Africa along with four new U.S. based sites. Also, top-line efficacy data from the REVEAL1 Phase 3 trial is on track to be reported in the fourth quarter of 2020. We're also evaluating VGX3100 in two separate Phase II trials for the treatment of vulvar H cell and anal H cell. Preliminary efficacy and safety data are planned to be provided later this month at the American Society for Coposcopy and Cervical Pathology, or ASCCP, 2020 Scientific Meeting on Anal General and HPV-Related Diseases.

And control historical control for MGMT, methylated patients and 75% versus 40% for MGMT unmethylated patients.

Inovios hope that our data continues to be positive.

With respect to historical controls.

Median overall survival for patients newly diagnosed with GBM.

Is approximately 12 months for MGMT, unmethylated patient population and slightly better in MGMT methylated population.

Just to give us a gauge historically about 60 66 zero percent of all patients, including both Unmethylated Unmethylated patients are alive at one year.

Dr. J. Joseph Kim: Now turning to immuno-oncology and our exciting progress on INO5401 for treating glioblastoma. In November of last year... Inovio reported positive interim data on our Phase 2 trial evaluating INO5401 for treating newly diagnosed GBM at the SITC 2019 Annual Meeting. INO5401 is a T-cell-activating DNA immunotherapy encoding for three tumor-specific antigens, H-TERC, WT1, and PSMA, and combined with INO9012, our immune activator that includes Interleukin-12.

We expect to report 12 months overall survival from our trial in June of this year in 2020.

Followed by 18 months overall survival in the fourth quarter.

With that I'll now ask our CFO, Peter keys to provide a financial update Peter.

Thanks, Joe So.

Inovio enters 2020 with a very strong balance sheet and cash position to continue finally research and development and the programs the Josef just talked about.

As we reported in our 10-K filed today cash cash equivalents in short term investments were 89.5 million as of December 30, Onest 29 team.

Dr. J. Joseph Kim: We're also evaluating these combinations with Lipteo, a PD-1 blocking antibody produced by Regeneron Pharmaceuticals in collaboration with Sanofi. Key early interim data from the 52-patient trial show that 80% of MGMT gene promoter methylated patients and 75% of MGMT unmethylated patients were progression-free at six months measured from the time of their first dose. This substantially exceeded historical standard of care data of approximately 60% for MGMT promoter methylated patients and about 40% for un-methylated patients. Again, just to reiterate, that was 80% versus 60% control, historical control, for MGMT methylated patients and 75% versus 40% for MGMT unmethylated patients. Inovio hopes that our data continues to be positive with respect to historical controls. The median overall survival for patients newly diagnosed with GBM is approximately 12 months for the MGMT-unmethylated patient population and slightly better in the MGMT-methylated population.

This compares to 93.8 million on our last reported quarterly earnings. In addition in the first quarter of this year from January one through March 11, 2020 the company.

Brought in net proceeds.

Of 208.2 million by selling common stock under its ATM agreement.

Based on the programs in development as of today.

Our yearend cash position plus whatever we've raised since year end provides inovio, where the strong multi year cash runway.

For the quarter and year ended December 30, Onest 2019 research and development expenses were 22 million, an 88 million respectively. This compares to 26.4 million and 95.3 million for the same periods in 2018.

The year or the year over year decrease in R&D expenses was primarily due to a decrease in employee compensation expense.

And drug manufacturing expenses related to our partnership.

Dr. J. Joseph Kim: Just to give us a gauge, historically, about 60% of all patients, including both unmethylated and methylated patients, are alive at one year. We expect to report 12 months overall survival from our trial in June of this year, in 2020, followed by 18 months overall survival in the fourth quarter. With that, I will now ask our CFO Peter Kies to provide a financial update.

With Astra Zeneca.

Among other small variances this decrease.

These decreases were offset.

By an increase in expenses related to clinical trials and a one time personnel related restructuring charge incurred during the third quarter of 29.

Total operating expenses decreased by roughly 8% this year.

Where we reported a 115.2 million for the full year in 2019, which compares to 124.6 million in 2018.

Peter D. Kies: Thanks, Joseph. Inovio enters 2020 with a very strong balance sheet and cash position to continue funding research and development and the programs that Joseph just talked about. As we reported in our 10-K filed today, cash, cash equivalents, and short-term investments were $89.5 million as of December 31, 2019. This compares to $93.8 million in our last reported quarterly earnings. In addition, in the first quarter of this year, from January 1 through March 11, 2020, the company brought in net proceeds of $208.2 million by selling common stock under its ATM agreement, based on the programs in development as of today.

Lastly, revenues for the fourth quarter and year and were 270000.

279000.

And 4.1 million respectively. This compares to 2.5 million and 30.5 million for the same periods in 2018.

This year over year decrease in revenue under collaborative research and development arrangements.

Was primarily due to the recognition of a one time upfront payment of 23 million from Apollo bile during the second quarter of 2018.

As a reminder, you can find our complete financial statements for the fourth quarter 2019 in today's press release and also in our 10-K filed with the FCC.

Todays 10-K can all be also be accessed on our website.

Under Investor Relations financial reports with that I'll turn it back to you Joseph.

Peter D. Kies: Our Urine Cast Physician, Plus, whatever we've raised since year-end provides Inovio with a strong multi-year cash runway. For the quarter and year ended December 31st, 2019, research and development expenses were $22 million and $88 million, respectively. This compares to $26.4 million and $95.3 million for the same periods in 2018. The year-over-year decrease in R&D expenses was primarily due to a decrease in employee compensation expenses and drug manufacturing expenses related to our partnership with AstraZeneca, among other small variances. This decrease... These decreases were offset by an increase in expenses related to clinical trials and a one-time personnel-related restructuring charge incurred during the third quarter of 2019. Total operating expenses decreased by roughly 8% this year, where we reported $115.2 million for the full year in 2019, which compares to $134.6 million in 2018. Lastly, revenues for the fourth quarter and year end were $270,000. $279,000, and $4.1 million, respectively. This compares to $2.5 million and $30.5 million for the same periods in 2018. This year-over-year decrease in revenue under collaborative research and development arrangements was primarily due to the recognition of a one-time up-front payment.

Thanks Peter.

Before we begin the QNX session I.

I want to recognize and thank all inovio employees for their countless hours of war that you have completed in response to the covered 19 outbreak while still executing your work on our core pipeline programs.

Inovios DNA medicines platform.

Is well suited to respond to disease outbreaks like this.

And it is our responsibility is it is our responsibility to play our part in serving public health interest.

Inovios dedicated capable and flexible to rise up and provide a solution for covered 19, and we'll look forward to sharing progress updates and results in the near future.

Please also stay tune regarding are very important phase two and phase three data catalyst for VGX 3100 for HPV related diseases, and I know 54, one for GBM.

20 Twond.

Will truly be a transformational year for inovio.

I look forward to taking your questions now operator, please open the line for the analysts.

We will now begin to question answer session to ask a question. You May proceed more than one on your Touchtone phone, if you're using a speakerphone. Please pick up your handset before pressing the keys to withdraw your question. Please press Star then too.

First question comes from Charles Duncan from Cantor Fitzgerald. Please go ahead.

Good afternoon chill in team.

Appreciate all the commentary on cold at 19 earlier in the call and.

Should you live in interesting times ahead question about that program and then a couple of your core pipeline programs.

A question on coded 19, Im just kind of wondering about the variability in the spike protein as you could provide us some sense of that.

Peter D. Kies: $23 million from Apollo Bio during the second quarter of 2018. As a reminder, you can find our complete financial statements for the fourth quarter of 2019 and today's press release and also in our 10-K filed with the SEC. Today's 10-K can also be accessed on our website under Investor Relations, Financial Reports.

Looking at co bid 19 versus other Corona gear day deal extent.

Not only activity for coal that 19, but also cross reactivity and potentially protection against other Corona viruses that could come out in the future.

Yeah, thank and chest.

So the Corona viruses as a family are not.

Dr. J. Joseph Kim: With that, I'll turn it back to you, Joseph.

As varian and some of the other our M&A or DNA viruses, like HIV or flu or or such.

Dr. J. Joseph Kim: Thanks, Peter. Before we begin the Q&A session, I want to recognize and thank all Inovio employees for the countless hours of work that you have completed in response to the COVID-19 outbreak while still executing your work on our core pipeline program. Inovio's DNA medicines platform is well suited to respond to disease outbreaks like this, and it is our responsibility to play our part in serving public health interests.

[music].

So we haven't really seen so much mutation.

Today, but we're still early and there's been various reports of variance and diversity, but I think those.

Those are still being determined and still controversial, but I can't tell you is.

Our overall DNA medicines platform.

Our approach with DNA vaccines using full length.

Energenic proteins.

But also being able to generate.

Operator: Inovio is dedicated, capable, and flexible enough to rise to and provide a solution for COVID-19, and we look forward to sharing progress, updates, and results in the near future. Please also stay tuned regarding our very important Phase 2 and Phase 3 data catalysts for VGX3100 for HPV-related diseases and INO5401 for GBM. 2020 will truly be a transformational year for Inovio. I look forward to taking your questions now. Operator, please open the lines for the analysts.

We'll see the a killer T cell responses.

Well as our antibody responses, we should be able to address any sort of minor dress.

Much better than other vaccine modalities, such as proteins are viral vector deliver programs. So while we will be continually surveying the potential of the changes in the coven 19 virus.

Or Saar scobey too.

We were quite confident in our approach using iron ore 4800.

Okay. That's very helpful in show and moving on to the core pipeline programs, considering the cervical dysplasia or 3100 program for reveal one and two I know reveal one is fully enrolled.

Operator: We will now begin the question and answer session. To ask a question, you may press star, then 1 on your touch-tone phone. If you are using a speakerphone, please pick up your handset before pressing the keys.

But in terms of two do you see any timing impact on enrollment due to any of the quarantine effects that you saw in Asia or social distancing that you are seeing in the states or or maybe we will see in the states going forward.

Charles Duncan: To withdraw your question, please press star, then 2. The first question comes from Charles Duncan from Cantor Fitzgerald. Please go ahead. Good afternoon, Joe and team. Appreciate all the commentary on COVID-19 earlier in the call and should you live in interesting times, I had a question about that program and then a couple of your core pipeline programs. My question on COVID-19, I'm just kind of wondering about the variability in the spike protein, if you could provide us some sense of that. You know, looking at COVID-19 versus other coronaviruses, do you expect not only activity for COVID-19 but also cross reactivity and potentially protection against other coronaviruses that could come out in the future?

Yeah.

Fantastic question, then and I think is just not for.

Our program, which we addressed in the risks additional risk factors in the 10-K.

I believe this endemic.

Corn of ours pandemic test the potential to disrupt many of.

The clinical trials and in drug development efforts, not just for inovio, but across the whole sector and across the globe.

That being said I don't expect major impact.

Of this pandemic on our ongoing trials not just for video on and too.

But also for our GBM and RFP now that not to say that there won't be future impact, but so far there hasn't been any significant impact on our timelines and execution.

Dr. J. Joseph Kim: Yeah, thank you, Chaz. So the coronaviruses, as a family, are not as variant as some of the other RNA or DNA viruses like HIV or flu or such. So we haven't really seen so much mutation to date, but we're still early. And there's been various reports of variance and diversity, but I think those are still being determined and still controversial. What I can tell you is that with our overall DNA medicines platform, our approach to DNA vaccines using full-length antigenic proteins, but also being able to generate both CD8 killer T cell responses, as well as our antibody responses, we should be able to address any sort of minor address. Much better than other vaccine modalities such as proteins or viral vector delivery programs. So while we will be continually surveying the potential of the changes in the COVID-19 virus, for SARS-CoV-2, we are quite confident in our approach using INO4800.

Okay, and then one last one for you and then one click loan for Peter in terms of you're seeing clinical meetings being canceled and I know you've got some results from phase two results coming up as well.

Eventually does to phase three results with reveal one but at least for the phase two results, if the clinical meetings or cancel or postpone that you're planning on present thing those results in which you would you just pre press release, some results or would you actually hold them and deadline.

For later on the year for presentation in a peer reviewed form.

Yeah, Great question.

No. This pandemic has been a unprecedented unprecedented event for many ways.

While I believe some of the banking conference's can be postponed in a science moves so I think having.

Delayed conferences may not make a great sense for some of the scientific and medical conferences. So we're going to be evaluating and reacting to some of these opportunities where some of these conferences are going to be holiday.

Dr. J. Joseph Kim: Okay, that's very helpful, Joe. And moving on to the core pipeline programs, considering the cervical dysplasia or 3100 program, for Reveal 1 and 2, I know Reveal 1 is fully enrolled, but in terms of 2, do you see any timing impact on enrollment due to any of the quarantine effects that you saw in Asia or social distancing that you are seeing in the States, or maybe we will see in the States going forward?

In a.

Virtually.

Abstracts will be published and maybe even posters and oil prices presentations can be made in a virtual fashion.

That's not the most ideal situation, obviously, we would like conferences.

SCR or ASCO to be where you're on barreling.

Dr. J. Joseph Kim: Yeah, fantastic question, and I think it's just enough for... Our program, which we addressed in the additional risk factors in the 10-K. I believe this pandemic, the coronavirus pandemic, has the potential to disrupt many of the clinical trials and drug development efforts, not just for Inovio, but across the whole sector and across the globe. That being said, I don't expect a major impact of this pandemic on our ongoing trials, not just for Revio 1 and 2, but also for RGBM and RRP. Now, that's not to say that there won't be a future impact, but so far, there hasn't been any significant impact on our timelines and execution.

Important data, but I think we have to react.

Logical and wisely to the outbreak situations so.

We're going to be evaluating this then and very quickly because we have a conference coming up.

Originally by end of this month for our than in a phase two data. So most likely will publish a press release and also when appropriate be able to talk about abstract then the poster presentation.

Okay sounds great one quick one for Peter Congrats on the use of the ATM bolstering the balance sheet.

You've had a lot of trading volume and that that helps but im wondering is it.

I'm not all that enamored with ATM is just because it's not always clear where that demand is coming from but do you sense that there is.

Dr. J. Joseph Kim: Okay, and then one last one for you, and then one quick one for Peter. In terms of, you're seeing clinical meetings being canceled, and I know you've got some results, some phase two results coming up as well, you know, eventually the phase three results with reveal one, but at least for the phase two results, if the clinical meetings are canceled or postponed that you're planning on presenting those results in, would you just press release the results, or would you actually hold them and delay that for later on in the year for a presentation in a peer-reviewed form?

Institutional investor demand that is that is part of that on them, but has that then the feedback.

Indefinitely, there's clearly some said there is.

A combination of retail and definitely institutional investors are mixed into that.

Okay. Thanks for the added thanks for taking more.

I expect to be updated filing gas.

Okay both times.

But yeah. When you have 100 million plus average in the last few days per day shares.

Dr. J. Joseph Kim: Yeah, a great question. You know, this pandemic has been unprecedented in many ways. While I believe some of the banking conferences can be postponed, you know science moves, so I think having delayed conferences may not make a great sense for some of these scientific and medical conferences, so we're going to be evaluating and reacting to some of these opportunities, where some of these conferences are going to be held virtually, abstracts will be published, and maybe even posters and oral presentations can be made in a virtual fashion. That's not the most ideal situation.

Aspect, we expect it's got to be a mix of both retail and institutions.

Yes, Thanks, Joe and Peter.

Thanks, Jeff.

The next question comes from Chris Raymond from Piper Sandler. Please go ahead.

Good afternoon to answer the Alstom wrap on for Chris Thanks for taking the questions. So.

Another on that on the Cronto Myrisk, obviously acknowledging that cover 19 fluid situation, but I guess I'm, hoping.

You can help us understand or expectations for the regulatory path forward for ion All party 800, I think maybe be helpful. If you could discuss your your takeaways from discussions with regulators and maybe just talk about what you see the most likely cap from from now to a million doses in hand by year end two widespread use 2021 and talk about.

Dr. J. Joseph Kim: Obviously, we would like conferences like AACR or ASCO to be where you're unbaffling important data, but I think we have to react logically and wisely to these outbreak situations. So we're going to be evaluating this and very quickly, because we have a conference coming up originally by the end of this month for our VIN and AIM Phase II data. So, most likely, we will publish a press release and also, when appropriate, be able to talk about the abstract and the poster presentation.

What kind of milestones, we should be looking for in the coming month.

Yeah. Thanks Sally.

Great question.

I was pretty face this by saying.

There are still a lot of uncertainties and things are moving.

I used this forward before unprecedented NVCA cancelling and other major sports canceling there.

The spending their seasons, and then CA tournaments, canceling so and our Kids School district has suspended for two weeks.

So I expect this type of.

Interruptions and disruptions to occur.

Charles Duncan: That sounds great. Just one quick one for Peter.

In the homeland and certainly we saw this type of.

Peter D. Kies: Congratulations on the use of the ATM, bolstering the balance sheet. You've had a lot of trading volume, and that helps. But I'm wondering, is it... I'm not all that enamored with ATMs just because it's not always clear where that demand is coming from. But do you sense that there is... institutional investor demand that is part of that? I mean, what has that been the feedback?

Dire situations in China, and Italy, and South Korea and elsewhere.

That being said.

What we know today is we have our laser focus our teams razor focused on getting iron ore 4800.

Into a first in man phase one clinical trial in the us.

Everything is really executing well.

Our ducs are lined up in order.

And I believe.

Our team is working very hard to live up to what our target was in starting our phase one trial in the U.S. in April.

Peter D. Kies: Yeah.

Charles Duncan: Definitely, there is a sense that there is a combination of retail and, definitely, institutional investors are mixed into that.

Peter D. Kies: Okay, thanks for the color. Thanks for

That being said we are we're also looking for two additional opportunities not just looking at the phase one objective of safety and Immunogenicity and the dosing levels of.

Peter D. Kies: What's more, I expect there will be updated filings at an appropriate time. But, yeah, when you have 100 million plus average in the last few days per day, shares, I expect, we expect it's going to be a mix of both retail and institutions.

30 4800.

We're looking at.

Potential to see early signals of efficacy.

And we're looking at and three.

Geographical areas.

Chris Raymond: Thanks, Joe and Peter. The next question comes from Chris Raymond on behalf of Piper Sandler. Please go ahead. Good afternoon. This is Alison Bradshawn on behalf of Chris.

The first is China would have a partnership with Beijing as vaccine.

To answer that territory with iron ore 4800, again with phase, one and add but we're looking to accelerate into an efficacy.

Alison Bradshawn: Thanks for taking the time to answer the question. So, another case of the coronavirus. Obviously, acknowledging that COVID-19 is a fluid situation, but I guess I'm hoping you can help us understand your expectations for the regulatory path forward for INL 4800. I think maybe it'd be helpful if you could discuss your takeaways from discussions with regulators and maybe just talk about what you see as the most likely path forward from now to a million doses in hand by year end and widespread use in 2021 and kind of talk about what kind of milestones we should be looking for in the coming months.

Setting as soon as were able to.

Second similar opportunistic trial opening in South Korea.

And thirdly as President Trump impressed upon to me during our conversation at the White House Task Force meeting. He said why don't you go to Seattle.

So, but unfortunately these could be in Philadelphia, where we are or San Diego or Los Angeles, or New York City. So.

So I believe we will be able to.

Act nimbly.

And Opportunistically.

After getting our early early safety and Immunogenicity of our vaccine.

And just putting on a crystal ball.

You know as situations calls for it.

Dr. J. Joseph Kim: Yeah, thanks, Ali. A great question.

And as the from the outbreak and as our funding partners than others support.

Dr. J. Joseph Kim: I would preface this by saying, There are still a lot of uncertainties, and things are moving. I used this word before, unprecedented, you know, NBA cancelling and other major sports cancelling there, suspending their seasons and NCAA tournaments cancelling, and our kids' school district has been closed for two weeks. So I expect this type of interruptions and disruptions to occur in the homeland. And certainly, we saw this type of dire situation in China, and Italy, and South Korea, and elsewhere. That being said, what we know today is that we have our razor focus. Our team's major focus is on getting INO4800 into a first-in-man, Phase I clinical trial in the U.S. Everything is... really executing well. Our ducks are lined up in order, and I believe our team is working very hard to live up to what our target was for starting our phase one trial in the U.S. in April.

We can provide up to 1 million doses of iron ore 4800 by the end of this year now I just want to be clear this could be use the million doses could be used for further testing in phase two or phase three setting number one number two.

If the regulatory and government agencies need then they could make arrangements to have than utilized in an emergency situation, but again.

Our goal is to make million doses, which is our current capacity using our existing and our network of contract manufacturers and our own met manufacturing capacity to deliver about a million doses by the year end.

And we have our focus on delivering on that.

Assuming the continuous need.

From the outbreak and the support of our very strong team of funders that we expect from globally and from the United States.

Thanks, and maybe a as a follow up to that.

Yeah on that device. So I, we saw you got to more funding to advance Cellectra three P.S.P. device.

Dr. J. Joseph Kim: That being said, we are also looking forward to additional opportunities, not just looking at the Phase I objectives of safety and immunogenicity and the dosing levels of the INO4800. We're looking at the potential to seek early signals of efficacy, and we're looking at it in three geographical areas. The first is China; we have a partnership with Beijing to enter that territory with INO4800, again in phase one, but we're looking to accelerate into an efficacy setting as soon as we are able to. Second, a similar opportunistic trial opening in South Korea. And thirdly, as President Trump stressed to me during our conversation at the White House Task Force meeting, he said, "Why don't you go to Seattle?"

Can you talk about additional testing work that needs to be done with a threepl PGR overall, just confidence level and the ability to scale up manufacturing capacity for that.

And just clarify I think VTX 3100 head to head of brings trial hold for an issue that was related to to that delivery device. That's five PSP. So just want to understand if that could be a gating factor. Thanks, Alright Ali let me just clarify very quickly last things first.

So electrify PSP currently.

Yes, being test the without any delay in reveal one and reveal two trials.

And and.

Prior to starting those phase three trials.

The FDA fast for additional testing.

So prior to the star we had slight delay of about six months.

Dr. J. Joseph Kim: So, but unfortunately, these could be in Philadelphia, where we are, or San Diego, or Los Angeles, or New York City, so I believe we will be able to..., at Nimbley, and opportunistically, after getting our early safety and immunogenicity of our vaccine. Just putting on a crystal ball, you know, as situations call for it, and from the outbreak and as our funding partners and others support. We can provide up to 1 million doses of INO4800 by the end of this year. Now, I just want to be clear, this could be used, the million doses, could be used for further testing in Phase 2 or Phase 3 settings, number one. Number two, if regulatory and government agencies need them, they could make arrangements to have them utilized in an emergency situation.

That selectra five PSP is currently operating extremely well in the field in the trials.

Which is a complete different.

Device.

And our nearly engineer than and scaling.

Commercial level.

Seen delivery device, we called that Selectra three PSP.

And I'm sure everyone has seen the announcement this morning that Bill and Melinda Gates Foundation has generally debt generously supported.

And they have been very strong supporter of Inovio for many of our R&D programs in the past.

For accelerating the scaling up and finalizing the testing for select trust three PSP.

You know this funding is going to go a long way in making that happen. We also had $8.1 million funding just for this device.

About a year ago.

And that had us start that development.

This additional funding is going to help us accelerate the completion of the testing as well as setting up the automated manufacturing lines in anticipation of delivering multimillion doses of VGX 40.

Dr. J. Joseph Kim: But again, our goal is to make a million doses, which is our current capacity using our existing and our network of contract manufacturers and our own manufacturing capacity to deliver about a million doses by the year end, and we have our focus on delivering on that, assuming the continuous need from the outbreak and the support of our very strong team of funders that we expect from globally and from the United States.

Sorry, I another 4800.

In the coming year.

In the coming years.

1 million doses can be deliver.

Utilizing our current pilots device.

Are there for planning for 50 million doses for 500 million doses as some of the public health experts are forecasting that will require a massively.

Alison Bradshawn: Thanks, and maybe as a follow-up to that on the device. We saw you got some more funding to advance the Selectra 3PSP device. Can you talk about additional testing work that needs to be done with the 3PSP and your overall confidence level and the ability to scale up manufacturing and capacity for that? And just to clarify, I think VTX3100 had a brief trial hold for an issue that was related to that delivery device, the 5PSP. So I just want to understand if that could be a gating factor.

Manufacturable device, what so with which Selectra three PSP represents.

And the cost effective a race the disposables that we have engineered and two selectra three PSP.

So we're quite.

Happy and grateful for the Gates Foundation funding, but also we are taxed we're happy to tackle this challenge of scaling up.

And we.

No I believe you should be.

Hearing more about.

These type of efforts that were putting in with a lot of directed external funding from various sources, we're very happy and grateful to seppi and the Gates Foundation.

Dr. J. Joseph Kim: Thanks.

Dr. J. Joseph Kim: All right, Ali, let me just clarify very quickly last things first. Phylectra 5-PSP currently is being tested without any delay in Reveal 1 and Reveal 2 trials. And prior to starting those phase 3 trials, the FDA asked for additional testing, so prior to the start, we had a slight delay of about 6 months. The Selectriot 5-PSP is currently operating extremely well in the field, in trials, which is a completely different device. Then our newly engineered and scalable commercial level vaccine delivery device; we call it Selectra 3PSP. And I'm sure everyone has seen the announcement this morning.

We expect this coalition of funders.

We'll continue to grow in the coming weeks and months.

Okay. Thanks for that clarification, thanks, Hi.

Thank you.

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

Yeah. Good afternoon. Thanks for taking my questions. A couple from me I guess first just regarding the.

3100 update and.

The other Enogen little HPV types can you just scheme.

Frame up I guess, what we should be expecting in terms of just the magnitude of patient data that we'll be seeing from from each so grouping.

Dr. J. Joseph Kim: that Bill and Melinda Gates Foundation has generally generously supported, and they have been a very strong supporter of Inovio for many of our R&D programs in the past, for accelerating the scaling up and finalizing the testing for Celectra 3PSP. You know, this funding is going to go a long way in making that happen. We also had $8.1 million funding just for this device about a year ago, and that got us started on that development. This additional funding is going to help us accelerate the completion of the testing as well as set up the automated manufacturing lines in anticipation of delivering multimillion doses of VGX-40, sorry, INO4800 in the coming year and years. You know, one million doses can be delivered using our current pilot device. But if we're planning for 50 million doses or 500 million doses, as some public health experts are forecasting, that will require a massively manufacturable device, which Selectra 3PSP represents, and cost-effective arrays, the disposables, that we have engineered into Selectra 3PSP. So, we're quite...

Maybe just give us a little bit of a framework for.

Some of the historical outcomes data that you.

You would expect seamless setting.

Yeah, so volpara in anyway so.

Our our orphan disease, so the number prevalence and incidence or.

Not as high as the cervical pre cancer, there were addressing with VGX 3100 in a phase three reveal one and two testing.

You know as you know we have.

We are conducting two small phase two trials.

For each other indications anal involve our a so while the indications have similar name.

These two diseases are very distinct and.

We have enrolled 24 eight so patients in this very targeted trial.

As well as enrolling 33 beauvoir eight so patients in a separate trial.

At the at the conference end of this.

One.

You know maybe in a electronic virtual form.

We plan to present at least 50%.

Dr. J. Joseph Kim: We are happy and grateful for the Gates Foundation funding. But also, you know, we're happy to tackle this challenge of scaling up. And I believe you should be hearing more about these types of efforts that we're putting in with a lot of directed external funding from various sources. We're very happy and grateful to CEPI and the Gates Foundation, but we expect this coalition of funders will continue to grow in the coming weeks and months.

Of these population.

What we're looking for our the regression of.

All of our Android so.

Down to low grade or are full clearance as well as the impact on HPV 16, or 18 borrowing infection. So.

In that regard the settings are and the approach.

Our similar.

Through our cervical age so phase two in phase three study.

We're very hopeful.

Alison Bradshawn: Okay, thanks for that clarification. Thanks, guys. Yep, thanks you. The next question comes from Stephen Wiley from Stiefel. Please go ahead.

To see the.

And present.

Positive response, and progressing HPV 16, or 18 specific eight so and evolve our and anal setting.

Stephen Wiley: Yeah, good afternoon. Thanks for taking the questions. A couple for me, I guess, first, just regarding the 3100 update and the other anogenital HPV types. Can you just frame up, I guess, what we should be expecting in terms of just the magnitude of patient data that we'll be seeing from each subgroup? And maybe just give us a little bit of a framework for some of the historical outcomes data that you would expect to see in this setting.

Okay. That's helpful and then I guess one on covered.

So I think the Mers vaccine that you guys haven't phase two is currently on.

Three dose schedule, which I think requires patient visits.

I think it's zero for 12 weeks.

Just kind of curious if you know now I guess based on some of your preclinical data whether or not you would expect a similar dosing schedule with coated.

Dr. J. Joseph Kim: Yeah, so Volvar and ANOH are orphan diseases. So the number of prevalence and incidents is not as high as the cervical pre-cancer they were addressing with VGX 3100 in a phase 3 review 1 and 2 testing. As you know, we are conducting two small Phase II trials for each of the indications, anal and vulvar H cell. While the indications have similar names, these two diseases are very distinct.

And I guess, maybe if you can just talk a little bit about how you how you envision kind of a protracted three dose regimen comment.

Turning out from.

Mass deployment.

Perspective.

Yeah, Steve Great question and the.

[music].

Yeah, we've learned that learned a lot.

So as we stated Caden I stated at the.

You know during our prepared remarks, we learned that from our immerse phase two ways study as well as.

Dr. J. Joseph Kim: We have enrolled 24 anal H cell patients in this very targeted trial, as well as enrolled 33 vulvar H cell patients in a separate trial. At the conference end of this, a month, you know, maybe in an electronic virtual form, we plan to present at least 50 percent of these patients. What we're looking for is the regression of vulvar or anoid cell down to low grade or full clearance, as well as the impact on So in that regard, the settings, and the approach, are similar to our cervical H cell phase 2 and phase 3 studies. We're very hopeful to see and present a positive response to regressing HPV 16 or 18 specific H cells in a vulvar and anal setting.

Earlier studies in the Bull HIV, and Zika and others.

We know.

100%.

Three doses three shots are better than two.

And who are better than one that's an absolute fat.

But we've also learned.

That.

Two injections or administrations in many times are sufficient.

And sometimes and the Merce vaccines case, we were able to completely protect or or have a very high protection and non human primates.

With just a single dose.

So I can tell you.

Stephen Wiley: Okay, that's helpful. And then I guess one on COVID. So I think the MERS vaccine that you guys have in Phase 2 is currently on a three-dose schedule, which I think requires patient visits at 0, 4, and 12 weeks. Just kind of curious if you know now, I guess, based on some of your preclinical data, whether or not you would expect a similar dosing schedule with COVID. And I guess maybe you could just talk a little bit about how you imagine, you know, kind of a protracted three-dose regimen kind of playing out from, you know, a mass deployment type of perspective.

Well I, rather not say, that's not public, but I'm pretty sure we're not going to be able to deploy a three dose regimen.

Or three visits for dosing in a pandemic setting maybe in Philadelphia or L.A., but not across the globe. So were looking for what the debate show and others have looked at an essay target product profile in a successful vaccine for.

Or coven 19.

Yes, the level that we will be.

Testing so.

I'm trying to dance around without providing any nonpublic information, but guess, what you're going to be able to see that very quickly in the net another month.

So I think you should stay tuned but.

Dr. J. Joseph Kim: Yeah, Steve, great question, and as we stated, Kate and I stated at the... You know, during our prepared remarks, we learned a lot from our MERS Phase 2a study, as well as our earlier studies in Ebola, HIV, and Zika, and others. We know 100% that three doses, three shots, are better than two, two are better than one. That's an absolute fact.

I can tell various not pandemic responses is not going to be optimally done was three dose regimen.

And is there a maximum amount of of vaccine I guess from milligram per dose perspective that can be administered via the previous be device.

Yes. It you know it's about 100.

Microliter volume.

So.

So thus intradermal route Wow.

Dr. J. Joseph Kim: But we've also learned that... Two injections or administrations many times are sufficient, and sometimes, in the MERS vaccine's case, we were able to completely protect or have very high protection in non-human primates with just a single dose. So I can tell you, well, I'd rather not say that's not public, but I'm pretty sure we're not going to be able to deploy a three-dose regimen or three visits for dosing in a pandemic setting, maybe in Philadelphia or LA, but not across the globe. So we're looking for what the WHO and others have looked at as a target product profile for a successful vaccine for COVID-19 That's the level that we'll be... testing. So, you know, I'm trying to dance around without providing any non-public information, but guess what? You're going to be able to see that very quickly in another month. So, you know, I think you should stay tuned, but I can tell you it's not, you know, the pandemic response is not gonna be optimally done with a three-dose regimen.

And our both enamored with that delivery route for our vaccine.

One limitation this the volume.

To deliver.

So you know where we are able to.

In preclinical models and some of which we have submitted to the nature communications and.

Available for anyone to look.

We're able to generate robust immune responses in those animal models.

Even with a single dose.

At the level that we're looking at.

For clinical studies so I.

I don't believe our vaccine delivery is gonna be volume dependent so much.

I believe we will be able to generate the relevant immune responses.

Using our vaccine dose that we are aiming to test the in the phase one studies.

Okay. So maybe just asked another way I guess the top dose that was explored and the most trial was.

<unk> 0.6, Migs should we assume that that's the highest dose of vaccine that you can provide for coated or is there.

Stephen Wiley: And is there a maximal amount of...

Stephen Wiley: of vaccine, I guess, from a milligram per dose perspective that can be administered via the 3PSP device.

No in terms of demand our offerings.

Yeah, not at all in our Ebola vaccine study.

Dr. J. Joseph Kim: Yeah, you know, it's about a hundred microliter volume. So, you know, it's an intradermal route while... You and I are both enamored with that delivery route for a vaccine. One limitation is the volume to deliver. So, you know, we are able to, in preclinical models, some of which we have submitted to Nature Communications, and it's available for anyone to look at, generate robust immune responses in those animal models, even with a single dose at the level that we're looking at for clinical studies. So, I don't believe our vaccine delivery is going to be volume-dependent so much. You know, I believe we will be able to generate the relevant immune responses using our vaccine dose that we are aiming to test in phase one studies.

With the similar type of setting.

Our higher dose was at two milligrams.

You know the merger study was testing a different part of hypothesis.

Where we were coming from a phase one study in the U.S. for immerse up to six milligram dosage using a intramuscular delivery. So we wanted to have a full spectrum of of dosing capability.

And.

We were able to learn a lot from that so obviously less you have to dose.

In the vaccine whether milligrams or volume.

More you can dose there in the pandemic setting so we'll be looking at.

Excluding doses in the levels.

Stephen Wiley: Okay, so maybe just ask another way. I guess the top dose that was explored in the MERS trial was 0.6 mg. Should we assume that that's the highest dose of vaccine that you can provide for COVID, or is there more room in terms of being able to concentrate that?

In these early phase one trials, but we'll have a pretty good idea based on our.

Long expertise and experience in these.

Vaccine studies, including Mers, and Ebola and HIV and others.

Where where we're age appropriate dose of.

Iron ore 4800 might be.

Stephen Wiley: No, not at all.

Dr. J. Joseph Kim: Not at all. In our Ebola vaccine studies, with a similar type of setting, our higher dose was at 2 mg.

You know Thats, why we do clinical studies to to optimize.

Those conditions.

Okay. Thanks, taking my questions.

Stephen Wiley: You know, the MERS study was testing a different part of a hypothesis, where we were coming from a Phase I study in the U.S. for MERS up to 6 mg dosage using an intramuscular delivery. So we wanted to have a full spectrum of dosing capability, and we were able to learn a lot from that. So, obviously, less you have to dose in the vaccine, whether in milligrams or volumes, the more you can spare in a pandemic setting. So now we will be looking at escalating doses at the levels in these early phase 1 trials, but we have a pretty good idea, based on our long expertise and experience in these vaccine studies, including MERS and Ebola and HIV and others, where an appropriate dose of INO4 But, you know, that's why we do clinical studies to optimize those conditions.

Thanks.

The next question comes from Gregory Renzo from RBC capital markets. Please go ahead.

Hey, guys. Thanks for taking my questions and thank you for the update today.

Just I just wanted to follow up on your commentary on the fluctuates device I think.

As you are advancing with the with the coded efforts increasing interest and demand on on hearing you basically just frame up the.

The user experience with the with the device the patient experience given that there are scores in terms of datasets available from your historical studies and just remind us on.

The pros and cons SBS electric demonstration experience. Thank you.

Stephen Wiley: Okay, thanks for taking the questions.

Gregory Renza: Thanks, Steve.

Gregory Renza: The next question comes from Gregory Renza from RBC Capital Markets. Please go ahead. Hey guys.

Yes. Thanks, Thanks, Greg the are so that's right threepi delivery intradermal really and we have published on this.

Dr. J. Joseph Kim: Thanks for taking my questions, and thank you for the update today. I just wanted to follow up on your commentary on this lecture device. I think as you are advancing with the COVID effort, with increasing interest and demand for hearing you basically frame up the user experience with the device, the patient experience, given that there are scores of datasets available from your historical studies, and just remind us of what that is, both the pros and the cons of the selector demonstration experience. Thank you.

The level of Palo Verde Tolerability.

Indexing studies has been very good.

In a zero to 10 bass score.

The patients reported pain score is around too.

Which is within the magnitude of what you may expect from conventional flu vaccine.

That one could expect from a from seasonal flu vaccination.

So.

Dr. J. Joseph Kim: Thanks, Greg. The Selectra 3P delivery intradermally, and we have published on this, the level of tolerability in vaccine studies has been very good. In a 0-10 VASC score, the patient reported pain score was around 2, which is within the magnitude of what you may expect from a conventional flu vaccine that one could expect from a seasonal flu vaccination. So, we're quite happy with the intradermal delivery using Selectra 3P. Obviously, from a user standpoint, the healthcare professional standpoint, 3PSP is a slick and well-designed, easy-to-use, and easy-to-manufacture device that's quite well-suited for mass production for pandemic-prepared efforts and preparing for large delivery of these vaccines. So, we're quite excited about the progress that we're looking to make in this arena, and accelerating the 3PSP device was a very important component of our overall COVID-19 vaccine scale-up strategy. Again, I can't be any more grateful, and we couldn't be any more grateful to the Bill and Melinda Gates Foundation for their continuing support.

We're quite.

Happy with.

The intradermal delivery using Selectra threepi.

Obviously from a user standpoint, the the healthcare professional standpoint.

Three PSP is a sleek.

Rick and well design.

Easy to use.

And easy to manufacture device, that's quite well suited for.

Mass production for.

That make prepare.

Efforts and preparing for.

Large delivery of these vaccines so.

We're quite excited about.

The progress that we're looking to.

To to make in this arena.

And accelerating the three PSP device.

So very important.

Component of our overall coven 19 vaccine scale up strategy and again I can't the anymore grateful and we can be anymore grateful to the bill and Melinda Gates Foundation for their continuing support.

Great. Thank you Joseph and then another follow up that as you have.

Gregory Renza: Great. Thank you, Joseph. And then another follow-up, as you have guided to the trials beginning for the COVID-19 asset in April, I just want to clarify that the 30 healthy volunteers is what you have shared. Are there efforts also with respect to positive cases after hearing your earlier commentary on Seattle and other regions? Just trying to get a sense of the patient population that you're identifying for the next step and what we can expect.

Got it to trials beginning or.

For the for the 19 assets in in April just want to clarify.

That the 30 healthy volunteers is what you have shared our there efforts also with respect to positive cases.

Sure in your commentary on Seattle, and other reason just trying to get a sense of.

The the patient population that you're identifying through the next up what we can expect.

Yeah, Greg.

Gregory Renza: Yeah, great. Thanks.

Thanks, The phase one study is going to target.

Dr. J. Joseph Kim: The Phase I study is going to target... healthy volunteers. And then we'll screen for questions, patients or volunteers to make sure they're not already infected with coronavirus. The probability is low, even today, with a little over a thousand persons. It's a growing number, but with 300 million-plus people in the U.S., I think we can find 30 or 40 healthy volunteers. But, you know, that's an opportunity post-phase one where, you know, there will be more potential volunteers that we can test the early signals of efficacy appropriately even in the U.S. So, wow, it is a growing concern for those of us who live in the U.S. But, you know, it's an opportunity to test our vaccine closer to home over time.

Healthy volunteers.

And then were full screen for.

You know patients or volunteers to make sure there.

They're not already infected with current of our so.

Oh, probably slow.

Even today.

With about dow's, let over thousand persons.

It's a growing number but with 300 million plus people in the U.S.

I think we can find 30 or 40, a healthy volunteers.

But you know that's that's a that's an opportunity post phase one where.

There will be increasing potential volunteer so it can test.

Early signals of efficacy.

Appropriately.

Even in the U.S. so.

While it is.

Growing concern for four for those of US who live in the U.S.

You know, it's a it's a opportunity to test our vaccine closer to home.

Dr. J. Joseph Kim: Got it.

Over time.

Got it thank you very much for taking the questions.

Gregory Renza: [inaudible]

Yeah. Thanks.

The next question comes from Jonathan Aschoff from Roth Capital Partners. Please go ahead.

Jonathan Ashoff: The next question comes from Jonathan Ashoff from Roth Capital Partners. Please go ahead. Thank you. I was wondering, are you guys going to use a coronavirus degenerative sequence, such that perhaps maybe the fourth time around, you have something already there to use for a broadly useful vaccine?

Thank you.

I was wondering you guys going to use a a a cooler blindly determinative sequinned such that perhaps into the fourth time around something already there to use.

No sorry broadly useful vaccine.

Oh Im sorry can you said it again Jonathan.

Jonathan Ashoff: I'm sorry. Can you say that again, Jonathan?

Jonathan Ashoff: You know, are you going to use a degenerative sequence to generate perhaps a coronavirus vaccine that could be useful against, you know, potentially all the coronaviruses that we might encounter such that there is one that you have in hand tested already the next time there is one of these outbreaks?

No our even use a degenerative sequence to generate perhaps the corona virus vaccine that could be useful against.

Potentially older Corona viruses that we might encounter such that there is one that you had been hand to test. It already the next time there is one of these on outbreaks.

Yeah, So very very good question.

Dr. J. Joseph Kim: Yeah, that's a very, very good question. You know, there are divergences among these different viruses in the coronavirus family. So

You know, there's there are divergence Andy.

From viruses and current of our family.

Dr. J. Joseph Kim: The quick answer is we don't have that yet. Our focus is on dealing with this COVID-19 pandemic. But we have research programs where, you know, extensive work has been done in researching and developing in the early stages of universal or very broadly protective flu vaccines. And we can certainly rely on some of those approaches. So a quick answer is no. You know, they're in the early stages of the outbreak. There were a lot of questions, and they were very valid questions.

So.

Quick answer is we don't have that yet.

Our focus is on dealing with this coven 19 pandemic.

But we have research programs where.

We have extensive work that was done in researching and developing in early stages of universal or very broadly protective flu vaccines and.

And we can certainly rely on some of those approaches so.

Okay quick answer is no.

You know there in the early stages of the outbreak.

There were a lot of questions a very valid questions.

Dr. J. Joseph Kim: Either, could we use our MERS vaccine that's been produced and already been tested to be safe and immunogenic in people? Could we use that? But, what we found out later, it probably wouldn't have a positive outcome.

Either.

Can we use our mers vaccine that's been produced an already been tested to be safe and Im Energenic and people can we use that you know the well we found out later, most likely wouldnt have a positive outcome.

Dr. J. Joseph Kim: You know, could you use the SARS vaccine? I think there are some researchers trying to address that, you know. From our understanding of vaccinology and immunology, those are good attempts and good questions. I think... [inaudible] the global organization that's really at the forefront of combating the future and current epidemic. That's what their thesis was, that we should at least make vaccines against known crazy pathogens, you know, really scary pathogens. And that's how they were able to fund our MERS and Lassa fever vaccine development. And having them in the 2020 outbreak with COVID-19, I believe, made a huge difference compared to when we didn't have CEPI just three years ago. So, you know, I believe organizations like CEPI and other rapidly responding companies like Inovio, and Moderna, and Novavax, and others, you know, we are the frontline fighters against this true enemy in this battle, which is the SARS-CoV-2 or COVI While we may have friendly competition in creating the best vaccine, the safest and most effective for COVID-19, we, Inovio, at least, have our eyes focused on who our real targets are and who our true enemy is in this SARS-CoV-2 virus.

Could you Sars vaccine there I think there are some researchers track to the draft that you know.

From our understanding index analogy and immunology.

Those are good tries and good questions I think.

It's not going to end up in a very positive outcome.

You are up you're thinking of creating preset vaccines for future outbreaks.

As almost similar to.

The agenda what started seppi.

The global organization Thats really at the forefront of combating these.

Feature and current epidemics.

That's what they're thesis was that we should at least make vaccines against known crazy pathogen really scary pathogens and and that's how they were able to fund our mers and last a fever vaccine development.

And having them.

In 2020 outbreak with Cowen 19.

I believe made a huge difference compared to when we then have seppi.

Just three years ago. So.

No I believe.

Organizations like Seppi, and other rapidly responding even companies like Inovio, and Madonna and Novavax and others.

We.

We are the frontline fighters against this.

This true enemy and this battle, which is the Sars koby, two or recorded 19, causing virus. So.

While we may have a friendly competition.

In creating divest vaccine most safe and effective for covered 19.

We inovio at least we have our eyes focused on who are real targets are and who are true enemy is in this first cohort two virus.

Jonathan Ashoff: Joe, how long do you think someone has to wait after receiving the first dose to have useful immunity?

Joe how long do you think someone has to wait after receiving the first dose to have you know a useful immunity.

Dr. J. Joseph Kim: Great question, you know, we wouldn't really be able to answer that definitively in patients until we have opportunities to do an efficacy-setting trial in animal models. Again, we have various challenge models that we're working with, collaborators across the globe. You know, animal challenge studies will help us address that question more definitively, but in MERS and Zika or other pathogenic challenge models in non-human primates, sometimes, you know, as early as two weeks, three weeks after the vaccination, you have built a sufficient level of immune responses and, you know, more different arms of the immune responses that you can generate. I believe could be additive, so, you know, one of the... Advantages I see that Inovio's DNA Medicine platform is the hallmark of the immune responses for our vaccines or immunotherapies has been

Great question.

You know, we wouldn't really be able to answer that the soon anyway.

And in in patients until.

We have opportunities to do an efficacy setting trial.

In animal models.

Again in and we have various challenge models that were working.

With.

Collaborators across the globe.

You know animal Challenge studies will help us address that question more definitively, but in mergers and zika or other.

Pathogenic challenge models.

Non human primates, sometimes.

You know as early as two weeks three weeks after the vaccination.

You have built sufficient level of.

Immune responses.

And you know more.

Different arms of the immune responses that you can generate.

I believe could be additive so one of the.

Advantages I see that Inovios DNA medicines platform has asked a hallmark of the immune responses.

For vaccines are Immunotherapies has been.

Dr. J. Joseph Kim: Our ability to generate very strong antigen-specific CD8 killer T cell responses, along with antibody responses directed to the target antigen. So I think the higher the level, the better, and multiple arms that you can access through vaccination should be helpful.

Our ability to generate very strong antigen specific CB eight killer T cell responses.

Along with antibody responses directed to the target antigens. So.

No I think hired to level, the better and multiple arms that you can access.

Vaccination should be helpful.

Jonathan Ashoff: Okay, and then lastly, when you said multi-year for a cash runway, it looks on my model to be about three years. Is that in the ballpark?

Okay, and then lastly, when you said multi year for a cash runway. It looks on my model to be about three years is that in the ballpark.

Peter D. Kies: Yes, that's in the ballpark. Thank you.

Yes, that's in the ballpark.

Jonathan Ashoff: Thank you very much. The next question comes from Ram Silvaraju from HC Wainwright. Please go ahead. Thanks so much for taking my question. Hi, thanks. So just a few that are non-COVID-19 and then a couple on COVID-19. Firstly, can you comment on when we might see the first clinical data from the 4700 program, please?

Thank you very much.

The next question comes from Ram Selvaraju from H.C. Wainwright. Please go ahead.

Thanks for taking my question Hi, Thanks.

So just a few that are non covert 19, but a couple on kogan Nike Firstly, Kevin can you comment on when we might see the first clinical data from the 4700 program. Please.

Our immerse vaccine and face once last two way.

Ram Silvaraju: or MERS vaccine in phase 1 slash 2A. Yeah. I believe this shows that the study is finishing up now, and we should be able to see, I mean, we have some of that data that's driving a lot of our planning for 4800, and we should be able to present and publish this study from Phase 1 plus 2A this year, in 2020.

I believe this year.

Study is finishing up.

Now and we should be able to see we should I mean, we have some of that data.

Thats driving.

Out of our.

Planning of 4800, and we should be able to present and publish.

The study from.

Phase once less to a study this year in 2020.

Okay, and then Oh this question without pertaining to the reveal.

Dr. J. Joseph Kim: Okay, and then I know this question was asked pertaining to the second Reveal study that has not yet reached full enrollment, but are you seeing any...

So the second reveal study that has not yet reached full enrollment but are you seeing any kogan 19 related potential perturbation of enrollment in any of the other ongoing non corona virus vaccine program studies.

Ram Silvaraju: Any COVID-19 related potential perturbation of enrollment in any of the other ongoing non-coronavirus vaccine program studies?

Dr. J. Joseph Kim: No, not yet. Well, it's always a possibility and has been a concern. However, it has not impacted any of our trials or other clinical studies.

No not yet.

Well, it's always a possibility and has been a consent.

It has not impacted any of our reveal or other clinical studies.

Dr. J. Joseph Kim: Um, it could, as the outbreak and, you know, it's just been declared a pandemic, and... If the virus spread even more widely, it could be more pervasive, and it could be a problem. But it's not just Inovio specific; I think it will be a society or..., or the whole sector specific potential threats.

It could.

As the outbreak and.

That's been declared pandemic again.

Yes stay at the virus spread even more widely it couldn't be more pervasive and and and it could be a problem.

But it's not just inovio specific I think it'll be a society or.

Or the whole sector specific.

Potential threats.

Ram Silvaraju: [inaudible] Okay, so that's specific to the COVID-19 program. Just a couple of questions here. When do you project your partner, Beijing Vaccine, would be able to kick off clinical testing in China?

Yeah, but so far no specific.

Okay. So that's specific to the cobot 19 program or just a couple of questions here.

When do you project your partner Beijing, I'd vaccine would be able to kick off a the clinical testing in China.

Yeah, we can't really provide an exact date at this time, our projected day, we know.

Dr. J. Joseph Kim: Yeah, we can't really provide an exact date at this time, but we will know as soon as possible, and it's going to be after April.

As soon as possible and and and it's gonna be after April.

Dr. J. Joseph Kim: Okay, are there any plans to test 4800 in South Korea?

Okay.

Are there any plans to test 4800 in South Korea.

Yes, we're also planning for that with additional collaborators and Sanders.

Dr. J. Joseph Kim: Yes, we're also planning for that with additional collaborators and funders.

Okay, and then just with respect to the seppi grants or.

Dr. J. Joseph Kim: Okay, and then just with respect to the CEPI grants, can you give us a sense of what specific activities relating to 4800 development that amount of grant funding would cover? And does that indeed cover all of the expenses associated with the Phase I study?

Can you give us a sense of what specific activities relating to 48 under development that.

Amount of grant funding would cover.

And does that indeed cover all of the expenses associated with the phase one study.

Yeah.

Dr. J. Joseph Kim: Yeah, so... There are, and as I said, we've had a two-year working relationship with CEPI, MERS, and Lassa. This $9 million, up to $9 million grant is supporting all of the preclinical efforts, including Clinical Product Manufacturing and also the conduct of Phase I clinical studies in the U.S. So, really, what, uh... You know, what you would expect from the completion of Phase I studies in the U.S. Okay, great.

So.

They are and as I said, we've had a two year working relationship with Seppinni on worse than last this 9 million up to 9 million dollar glass.

Is supporting all of the preclinical efforts, including clinical product manufacturing.

And also the conduct of phase one clinical studies in the U.S.

So really what are what.

Yeah, what you would expect from the completion of phase one studies.

In the U.S.

Okay, great. Thank you very much.

Ram Silvaraju: Okay, great. Thank you very much.

Ram Silvaraju: Yep, thanks, Tom.

Yes. Thanks.

Dr. J. Joseph Kim: There are no more questions in the queue. This concludes our question and answer session. I would like to turn the conference back over to Joseph Kim for any closing remarks.

There are no more questions in the Q.

This concludes our question and answer session I'd like to turn the conference Becker richness of Kim for any closing remarks.

Dr. J. Joseph Kim: Thank you everyone for joining us today. We look forward to speaking with you again soon. Have a great evening.

Thank you everyone for joining us today.

We look forward to speaking with you again soon have a great evening.

Operator: The conference has now concluded. Thank you for attending today's presentation. You may now disconnect.

The conference has now concluded. Thank you for attending today's presentation you may now disconnect.

[music].