Q3 2019 Earnings Call

Good afternoon, everyone and welcome to Inovios third quarter 2019 financial results Conference call.

Operator: Good afternoon, everyone, and welcome to Inovio's third quarter 2019 financial results conference call. All participants will be in a listen-only mode. Should you need assistance, please say no to 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 and then 1. To withdraw yourself from the question queue, you may press star and two. Please note, today's event is also being recorded. At this time, I'd like to turn the conference call over to Mr. Ben Matone, Senior Director of Investor Relations. Sir, please go ahead.

All participants will be in listen only mode should you need assistance, placing all conference specialist by pressing the Starkey followed by zero.

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

Ask a question you May press Star then one to withdraw yourself from the question Q, You May press Star and Sue.

Please note today's event is also being recorded.

At this time I like to turn the conference call over to Mr., Ben Midtown Senior Director Investor Relations. Sir. Please go ahead.

Ben Matone: Thank you, operator. Good afternoon, and thank you for joining the Inovio Pharmaceuticals third quarter 2019 earnings conference call. On the call today are Inovio's President and CEO, Dr. Jay Joseph Kim, our Chief Financial Officer, Peter Kies, and Dr. Jeffrey Skolnick, Vice President of Clinical Oncology Development. Today's call is being webcast live on our website, ir.inovio.com, and a replay of today's call will be made available shortly after the call is concluded.

Thank you operator, good afternoon, and thank you for joined the Inovio Pharmaceuticals third quarter 2019 earnings conference call on the call today, our Inovios, President and CEO dR.J., Joseph Kim Our Chief Financial Officer, Peter Keith and Dr., Jeffrey Skolnick, Vice President of clinical oncology development today.

This call is being webcast live on our website IR Inovio dot com and a replay of today's call will be made available shortly after the call is concluded.

Ben Matone: Following a general business update, we will conduct a question and answer segment, which will be reserved for equity research analysts. On 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 synthetic DNA immunotherapies in combination with our proprietary delivery devices, as well as clinical and regulatory developments and timing of clinical data readouts along with our capital resources. All of 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-Q filing with the SEC. With that said, I would now like to turn the call over to Inovio's President and CEO, Dr. J. Joseph Kim.

Following a general business update we will conduct a question and answer segment, which would be reserved for equity research analysts on this call we will be making forward looking statements that relate to our business, which include our plans to develop inovios integrated platform synthetic DNA immunotherapies in combination with our proprietary delivery devices as.

Well, its clinical and regulatory developments and timing of clinic gold data read outs, along with our capital resources.

All of 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 could 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, including today's 10.

Q filing with the SEC with that I would now like to turn the call over to Inovios, President and CEO dR.J. Joseph Kim.

Dr. J. Joseph Kim: Thank you, Ben, and thank you everyone for joining the call and webcast. As we near the close of the year, I do want to spend some time reflecting on our 2019 accomplishments, but also focus more on 2020 as a transformative period for Inovio. Let me take us on a time machine to November 2020. By this time next year, we will have shown you.

Thank you Ben and thank you everyone for joining on the call and webcast.

As we near the close or the air.

I do want to spend some time, reflecting on our 2019 accomplishments, but also focus more on 2020 and say transform into Korea for Inovio.

Let me take us on a time machine to November 2020.

Hi, This time next year, we will all have shown in.

Dr. J. Joseph Kim: JVM overall survival data at 12 and 18 months for INO5401. Reveal 1 top-line efficacy data for our Phase 3 cervical dysplasia product, VGX3100. PGX 3100 Phase 2 results for both vulvar and anal dysplasia, and RP Study Up and Running via Orphan Designation. Our last vaccine will be in a Phase 1b trial in Africa, and our MERS vaccine in Phase 2 studies in the Middle East, all with full funding from Step. Our Chinese partner, Apollo Bio, will be in Phase 3 in China with VGX 3100, and we expect AstraZeneca Oof, what an incredible set of value drivers in one year. But, let me turn off my time machine and focus on the present.

GBM overall survival data at 12, and 18 months for I know 54 one.

Reveal one topline efficacy data for our phase three cervical dysplasia product VGX 3100.

Pgx 3100 phase two results for both Volvo car and annual dysplasia.

And our peak study up and running via orphan designation.

Our last the vaccine will be in a phase one be trial in Africa.

And our Mers vaccine in phase two study in the Middle East.

All with full funding from Seppi.

Our China part cleaner Apollo bio will be in phase three in China with VGX 3100.

Then we would expect Astra Zeneca report on phase two head and neck cancer efficacy results with Mehdi 057 combine with their checkpoint inhibitor.

Well what was incredible set of value driver in one year.

Let me turn off my time machine and focus on the present.

Last week, we reported positive interim data from our ongoing phase two trial of our newly diagnosed glioblastoma multiforme or GBM, which combines inovios I know 54, or one of T cell activating immunotherapy encoding for three tumor specific.

Dr. J. Joseph Kim: Last week, we reported positive interim data from our ongoing Phase II trial of our newly diagnosed glioblastoma multiforme, or GBM, which combines Inovio's INO5401, a T-cell activating immunotherapy encoding for three tumor-specific antigens, H-TURK, WT1, and PSMA, as well as INO9012, an immune activator encoding for interleukin-12, In summary, the key interim data from the 52 patient clinical trials showed that 80% of MGMT gene promoter methylated patients and 75% of unmethylated patients were disease progression-free at six months, measured from the time of their first dose. These results substantially exceed historical standard of care data. That data was presented at the Society for Immunotherapy of Cancer annual meeting last week. Next year, Inovio will report 12- and 18-month overall survival data. Before we go into the other cancer combination program updates, we'll have Dr. Jeffrey Skolnick, who heads up Inovio's immuno-oncology development and who last week presented this data at CIDSE, to provide some more granularity on this data and how it compares to the historical standard of care. Jeffrey?

Began engines.

Mr. WT, one NPS umang.

That's wireless I know 90, 12, and immune activator, including four interleukin 12 in combination with live Tayo Regenerons PD one inhibitor.

In summary, the key interim data from the 52 patient clinical trial showed that 80% of MGMT gene promoter methylated patients and 75% of Unmethylated patients where disease progression free at six months.

Measure from the time of their first dose.

These results substantially exceed historical standard of care data.

That data was presented at the society for immunotherapy of cancer annual meeting last week.

Coming next year Inovio will report well, then 18 months overall survival data.

Before we go into the other cancer combination program update we'll have Dr., Jeffrey Skolnick, who heads up Inovios immuno oncology oncology development, who last week presented this data sets. The can provide some more granularity on this data and how it compares to historical standard of care.

Jeffrey Thank you Jess.

Dr. J. Joseph Kim: Thank you, Jez. As Joseph mentioned in his opening remarks, last week was very positive for our GBM program, and we're very excited to share this new clinical data with both the clinical and investment community. The excitement over these data was obvious to me as our late-breaking CITSE poster presentation garnered significant attention from meeting attendees. We want to emphasize that glioblastoma is a disease that is extremely challenging to treat, and most patients die of their brain cancer within one to two years of their diagnosis. In our latest interim data, we demonstrated that 75% of our MGMT promoter unmethylated patients and 80% of our MGMT promoter methylated patients were progression-free at six months. This is very favorable when we compare them to historical controls; we would expect only about 40% of unmethylated patients and about 60% of methylated patients to be progression-free at six months. We were also very excited that almost all patients tested so far generated antigen-specific T cells to the tumor-associated antigens created by our therapy. And we look forward to our data next year, as you've indicated, Joseph, to potentially confirm an overall survival benefit. Thank you, Jeff.

As Josef mentioned in his opening remarks last week was very positive for our GBM program and we're very excited to share this new clinical data with both the clinical and investment community you.

The excitement over these data was obvious to me is our late breaking Sisi poster presentation garnered significant attention from meeting attendees.

We want to underscore the Glioblastoma is a disease that is extremely challenging to treat.

That most patients die of their brain cancer within one to two years of their diagnosis.

Our latest interim data reveal we demonstrated that 75% of our MGMT promoter unmethylated patients and 80% of our MGMT promoter methylated patients were progression free at six months. This is very favorable when we compare them to historic.

Controls, we would expect only about 40% of unmethylated patients and about 60% of methylated patients to be progression free at six months.

We were also very excited that almost all patients tested so far generated antigen specific T cells to the tumor associated antigens created by our therapy and we look forward to our data next year as you've indicated Joseph to potentially confirm in overall survival benefit.

Dr. J. Joseph Kim: Thank you, Jeffrey. While we certainly can appreciate that this is a very difficult to treat cancer, we should all feel encouraged by this new data and what it really means for the future of Inovio's capabilities in immuno-oncology and for patients suffering with GBM, who have not witnessed any new effective treatments for years. Furthermore, I want to stress here that GBM data provides two additional far-reaching implications. First, because the tumor-associated antigens comprising INO5401, namely HTIRT, WT1, and PSMA, are also overly expressed in dozens of other cancers, we can potentially use INO5401 to treat many of these cancers. These are pancreatic, renal, ACC, lung, gastric, and other cancers.

Thank you Jeffrey.

While we certainly can appreciate that this is a very difficult to treat cancer. We should all feel encouraged by this new data and what it really means for the future of inovios capabilities, and immuno oncology and for patients suffering with GBM.

Who have not witness any new effective treatments for years.

Furthermore, I want to stress here. The GBM data provides two additional far reaching implications first because the tumor associated antigens, comprising I know 54, one, namely H. turret WT one NPS. A me are also overly expressed in doesn't.

End of other cancers, we can potentially use it to treat many of these cancers.

As our pancreatic Reno HCC long gastric and other cancers, we plan to comprehensively and methodically address these opportunities, perhaps with a global partner.

Dr. J. Joseph Kim: We plan to comprehensively and methodically address these opportunities, perhaps with a global partnership. Second, our GBM data also validates our overall Syncon platform for utilizing other important tumor-associated antigens we have developed as additional cancer products. Thus, while our INO5401 GBM program is certainly very important for the patients suffering from GBM and represents a great commercial opportunity for Inovio, we are just beginning to witness only the very tip of this peak, with even a greater mountain of opportunities below it. I begin our call today by referencing 2020 as a transformative year for Inovio, and we have been working for a while to make this possible. We have been preparing it with strategic portfolio management, workforce adjustments, and funding support. When we look at where Inovio is today, I see a more sharpened resolve than where we were just two years ago.

Second our GBM data also validates our overall finchem platform for utilizing other important tumor associated antigens. We have developed this additional cancer products.

Yes, well, our I know 54 ones you'd be in program is certainly very important for the patients suffering from GBM and represents a great put that commercial opportunity for you know view. We are just beginning to witness only the very Pippa. This peak with even a greater mountain of opportune.

That is below it.

I began our call today referencing 2020, as a transformative year for Inovio.

And we have been working for a while to make this possible we haven't preparing it with strategic portfolio management workforce adjustments and funding support.

When we look at where Inovio is today.

I see a more sharpen resolved than where we were just two years ago.

Dr. J. Joseph Kim: Our core focus continues to be on advancing our versatile HPV treatment capabilities that target HPV-related diseases, which lack therapeutic alternatives to surgery. And we add to that our strategies to develop fast-to-market products like RRP and GBN. First, let me address our most advanced asset, VGX 3100. Beginning with our phase three trial for treating women with high-grade cervical dysplasia, we completed enrollment of 198 patients in the second quarter for REVEAL-1, and we remain on target to provide top-line efficacy data from the REVEAL-1 trial by the fourth quarter of 2020. We are looking forward to seeing if we can achieve the efficacy and safety data in Reveal 1, which we have already demonstrated in a 167-patient Phase 2B study. Remember, cervical cancer is still one of the leading causes of death in women globally, and HPV 16 and 18 subtypes addressable by VGX 3100 are still responsible for about 70% of cervical cancer.

Our core focus continues to be on the van thing, our versatile HPV treatment capabilities that yet.

PV related diseases, which lack therapeutic alternatives to surgery.

And we add to that our strategies to develop fast to market products like RFP and GBM.

First let me address our most advanced asset VGX 3100, beginning with our phase three for treating women with high grade cervical dysplasia, we completed enrollment of 198 patients in the second quarter for reveal one and we remain on target to provide.

Topline efficacy data from reveal one trial by the fourth quarter of 2020.

We are looking forward to sing it for can achieve the efficacy and safety data and reveal one which we had already demonstrated in a 167 patient phase Twob studies.

Remember cervical cancer is still one of the leading cancer costs of death, and women globally, and HPV 16, and 18 sub types addressable by VGX 3100 are still responsible for about 70% of cervical cancer.

Dr. J. Joseph Kim: Thus, all the more reason why we believe our immunotherapy for pre-cancers as an effective and proactive alternative to surgery will be graciously accepted among the patient community. Meanwhile, we continue to be both vigilant, diligent, and cost-effective in opening clinical sites for Revio2 within the U.S. and globally. As of the end of October, we have 31 sites actively recruiting and enrolling patients globally, having recently opened new sites in Argentina, Lithuania, and Spain. Overall, enrollment for VO2 remains on track.

Does all the more reason on why we believe our immuno therapy to pre cancers as an effective and proactive alternative to surgery will be graciously accepted among the patient community.

Meanwhile, we continue to be both vigilant diligent and cost effective on opening clinical sites for reveal too within the U.S. and globally.

As of the end of October we have 31 sites actively recruiting enrolling patients globally, having recently opened new sites in Argentina, Lithuania, and Spain overall enrollment for real soon remains on course.

Dr. J. Joseph Kim: As a reminder, while both revealed trials will be required to file a BLA, keep in mind that these two trials are identical, with one exception being safety follow-up timing. Reveal 1 being an 88-week long trial, which includes a one-year safety follow-up, versus a 40-week long trial for Reveal 2, which includes a one-month safety follow-up. Coupled with our upcoming clinical data and improving the commercial profile for VGX 3100 will be the pre-treatment biomarker and diagnostics kit we are co-developing with our collaborator QIAGEN. Again, the purpose of this kit is to identify patients most likely to respond to VGX 3100. So while the most significant update for VGX 3100 will occur later next year, that being phase 3 reveal one top-line data, we do anticipate data readouts from our ongoing phase 2 VIN and AIM programs over the next few months.

As a reminder, while both reveal trials will be required to file I'd be a delay.

Keep in mind that these two trials are identical with one exception of being safety follow up timing.

Reveal one being an 88 week long trial, which includes a one year safety follow up versus a 40 week long trial for reveal too which includes a one month safety follow up.

Coupled with our upcoming clinical data and improving the commercial profile for VGX 3100 will be the pretreatment biomarker and diagnostics kit, we are co developing with our collaborator equation.

Again, the purpose of this kid identify patients most likely to respond to VGX 3100.

So while the most significant update for VGX 3100 will occur later next year that being phase three reveal one topline data, we do anticipate data readouts from our ongoing phase two Vin and 18 programs over the next few months.

Dr. J. Joseph Kim: Following the completion of enrollment of 33 patients in our Phase 2 trial of VGX3100 for HPV-related high-grade vulvar dysplasia, as well as the completed enrollment in our 24-patient Phase 2 trial in patients with HPV-related high-grade anal dysplasia, we plan to report interim data from both the VIN and AIM studies at a medical conference in the first quarter of next year. While we can't provide specifics on the conference at this time, we feel that this will be the most appropriate venue to share VIN and AIM interim efficacy and safety data, garnering the most attention and appreciation for these disease targets. Lastly, as it relates to new significant HPV target opportunities, we continue to have discussions with the FDA and are confident that we will be in a position to initiate a pivotal clinical trial of INO3107 for HPV-related RRP, which we expect to move forward as a rare orphan product within the first half of 2020. RRP, or Recurrent Respiratory Papillomatosis, is a disease where the patients literally have to schedule their lives around planning, undergoing, and recovering from surgery, having surgery sometimes as much as three to ten times a year and spending annually as much as $500,000, as many of them have multiple overnight stays in the hospital and require multiple post-surgery medications.

Following the completion of enrollment of 33 patients.

In our phase two trial.

Your next 30, 104, HPV related high grade Valbart dysplasia as well as the completing enrollment in our 24 patients phase two trial.

In patients with HPV related high grade annual dysplasia, we plan to report interim data from both the van and named study at a medical conference in the first quarter of next year.

Well, we can provide specifics on the conference at this time, we feel that this will be the most appropriate venue to share Vin and 18 interim efficacy and safety data garnering the most attention and an appreciation for the disease targets.

Lastly, as it relates to new significant HPV target opportunities. We continue to have discussions with the FDA and are confident they we will be in a position to initiate a pivotal clinical trial Bayano 31 of seven for HPV related RFP.

Which should we expect to move forward as a rare orphan products within the first half of 2020.

RFP or recurrent respiratory papilloma ptosis is a disease, where the patients literally have to schedule their lives around planning.

Undergoing and recovering from surgery, having surgery, sometimes as many as much as three to 10 times, a year and spending annually as much as $500000 as many of them have multiple overnight stays in the hospital and require multiple post surgery Medicaid.

Patients.

Dr. J. Joseph Kim: So I know all of you share our eagerness to get the study off the ground and share our excitement about the tremendous market opportunity that this program has, and, most importantly, the clinical benefit it offers to patients who are constantly reminded of this terrible disease. I should also mention that in addition to INO5401 presented as a late-breaker poster at CITSE, INO5151, which is a combined formulation of INO 5150 and INO 9012, is being incorporated in one arm of this exploratory cohort platform study, three-cohort platform study, being conducted by the Parker Institute for Cancer Immunotherapy and Cancer Research Institute as part of the company's previously established clinical collaboration agreement.

So I know all of you share our eagerness to get the study off the ground and share our excitement about the tremendous market opportunity that this program has.

And most importantly, the clinical benefit it offers to patients that are constantly reminded of this terrible disease.

I should also mentioned that in addition to identify 54, one presented as a late breaker poster at city. I know 51 51 was also featured in a try and trial in progress poster at the same conference.

I know 51, 51, which is a combination comp combined formulation of iron ore 51, 50, and iron ore 90, 12 is being incorporated in worn one arm of this exploratory cohort platform study three core platform study.

Being conducted by the Parker Institute for cancer immunotherapy.

And cancer Research Institute as part of the company's previously established clinical collaboration agreement.

Dr. J. Joseph Kim: In this particular cohort, INO5151 is being combined with Bristol-Myers' PD-1 inhibitor, nivolumab, and CellsX Therapeutics' FLT3 ligand, CDX301. Let me again emphasize that in our cancer combination portfolio, you can expect overall survival data from our INO5401 cancer combination trial with Regeneron for GVM, building upon the promising PFS6 data that was recently presented. Moreover, the fully enrolled head and neck cancer phase 2 trial sponsored by our partner AstraZeneca combining Medi-0457 with AZ checkpoint inhibitor will be completed by the third quarter next year.

In this particular cohort I know 51, 51 is being combined with Bristol Myers is PD, one inhibitor nivolumab and sell sex therapeutics slit three lag and Cdx 301.

Let me again emphasize here that our cancer combination portfolio you can expect overall survival data from our iron ore 54, one cancer combination trial with Regeneron for GBM building upon the promising PFS six data that was recently presented.

Moreover, the fully enrolled head and neck cancer phase two trial sponsor by our partner Astra Zeneca, combining Mehdi 0457 with AG checkpoint inhibitor will be completed by the third quarter next year.

Collectively these anticipated efficacy data readouts in 2020, all point to create process for Inovios product pipeline and further solidify inovio as the leader in in synthetic DNA immunotherapy.

Dr. J. Joseph Kim: These anticipated efficacy data readouts in 2020 all point to great promise for Inovio's product pipeline and further solidify Inovio as the leader in synthetic DNA immunotherapy. Before I turn it over to Peter for a financial update, well, we're certainly excited about the continued development being done within cancer and HPV. I'd be remiss not to mention the latest progress within our infectious disease business, recognizing that this is an area which I believe is often underappreciated by investors. As we stated back in July, while we narrowed our resources and focus within infectious diseases, our previously established global partnerships were not affected by this realignment.

Before I turn it over to Peter for a financial update.

While we are certainly excited about the continued development.

Being done within cancer in HPV.

I'd be remiss not to mention the latest progress within our infectious disease business.

Recognizing that this is an area, which I believe is often underappreciated by investors.

As we stated back in July while we narrowed our resources and focus within infectious diseases. Our previously established global partnerships were not affected with this realignment, we continue to utilize and embrace our ongoing partnerships for the development of both vaccines female.

Dr. J. Joseph Kim: We continue to utilize and embrace our ongoing partnerships for the development of both vaccines, DMABS, and delivery devices, which support the development and investigation of multiple pandemic and infectious disease targets. In fact, I have an update for you on our Lassa and MERS vaccines. Vaccines, funded by our infectious disease partner CEPI, or the Coalition for Epidemic Preparedness Innovation. For LASA, we completed enrollment in the first ever human vaccine study where we began enrollment in May of this year. Looking ahead, and based upon the performance of the Phase 1 trial with INO4500, our partner CEPI will continue to fund the next Phase 1b trial for Lassa in West Africa, where the Lassa infection is endemic. This trial is expected to begin enrollment early next year.

ABS and delivery devices, which support the development investigation of multiple pandemic and infectious disease targets.

In fact, I have an update for you from our last sudden mers vaccine vaccines funded by infectious disease partners Seppi or the coalition for epidemic preparedness innovations.

For Alaska, we completed enrollment of the first ever human vaccine study, where we began enrollment in may of this year.

Looking ahead and based upon the performance of the phase one trial with iron ore 4500, our partner Seppi will continue to fund the next phase one be trough or less.

In West Africa, where last infection is endemic.

This trial is expected to begin enrollment early next year.

Dr. J. Joseph Kim: Additionally, in moving to our vaccine for MERS, Inovio again will lead all other organizations and begin the first ever Phase II study in the Middle East and Africa, where outbreaks have been observed. We're also waiting for our partners to finish analyses for our Zika vaccine in Puerto Rico, as well as our HIV vaccine study. Moreover, we're making advancements in our DMAB and DBAI technologies, and you will certainly hear more about them in the future.

Additionally, and moving to our vaccine for Mers.

Inovio again will lead all other organizations and begin the first ever phase two study in the Middle Eastern Africa.

Outbreaks had been observed.

We're also waiting for our partners to finish analyses for Zika vaccine in Puerto Rico.

As well as our HIV vaccines studies.

Moreover, we're making advancements in our team and the by technologies and knew you will certainly hear more about them in the future.

Dr. J. Joseph Kim: Using direct local delivery into the body by the Selectra platform, the synthetic genetic codes provided by the DMAP instruct the body's cells to become a customized, patient-specific factory that manufactures their own therapeutic monoclonal antibody product, enabling a major leap in antibody technology. Traditional monoclonal antibodies represent the largest segment of pharmaceutical markets today, accounting for more than $100 billion in pharmaceutical sales last year, with treatments spanning cancer, infection, inflammation, With its synthetic design and inpatient production, DMAP products represent a disruptive and innovative entrant to this important class of pharmaceuticals. Collectively, DMAB and DBITE offer the opportunity to provide superior and cost-effective therapeutic options across cancer and infectious diseases. Inovio has already received over $60 million in external funding to support the advancement of this technology.

Using direct local delivery into the body by Selectra platform.

Synthetic genetic codes provided by the demands.

Instruct the body cells to become a customized patient specific factory, which manufactures their own therapeutic monoclonal antibody products.

Enabling a major lead antibody technology.

Traditional monoclonal antibodies represent the largest segment of pharmaceutical markets today accounting for more than $100 billion in pharmaceutical sales last year.

Treatments spanning cancer infection inflammation and cardiovascular disease.

With his synthetic design and inpatient production.

Mmm products represent a destructive and innovative entrant to this important class of pharmaceuticals.

Collectively demand and the by offer the opportunity to provide superior and cost effective therapeutic options across cancer and infectious diseases.

Inovio has already received over $60 million in external funding to support the advancement of this technology.

Dr. J. Joseph Kim: Most recently, Inovio and its collaborator, the Wistar Institute, received a $4.6 million grant from the National Institutes of Health in support of continued development of Inovio's DMAP, an innovative application of this technology to develop antimicrobial resistance products. Inovio's overall goal is to create a paradigm shift in monoclonal antibody technology that results in a pipeline of high-impact DMAP products for cancer and infection, which can be developed with corporate partnerships, external funding, and collaboration. As an example, earlier this year, Inovio advanced its first ever DMAP candidate, INO-A002, to a Phase I Dose Escalation Trial to assess safety and tolerability and expression of DMAP-produced antibodies with full funding from the Bill and Melinda Gates Foundation. Stay tuned for the data to be reported in 2020. With that in mind, I will ask our CFO, Peter Kies, to provide a financial update. Peter?

Most recently Inovio and this collaborator the with Star Institute received a 4.6 million dollar grant from the National Institutes of health in support of continued development of Inovio steam apps.

And innovative application of this to develop and time microbial resistance products.

Inovios overall goal is to create a paradigm shift approach to monoclonal antibody technology that results in a pipeline of high impact team at products for cancer infection, which can be developed with corporate partnerships external funding and collaboration.

As an example earlier this year Inovio offenses first ever DMR candidate I know a double to.

Two phase one dose escalation trial to assess safety and Tolerability and expression of the map produce antibodies with full funding from the Bill and Melinda Gates Foundation.

Stay tuned for the data to be reported in 2020 with that I will ask our CFO Peter keys to provide a financial update Peter.

Peter D. Kies: Thanks, Joseph, and good afternoon, everyone. I'll begin with a general overview of the third quarter financial results and then also touch on the recent realignment that we announced in July. Total revenue for the third quarter was $867,000 compared to $2 million for the same period in 2018. Total operating expenses were $24.8 million for the three months ended September 30, 2019, compared to $28.6 million for the same period last year. The year-over-year decrease in revenue under collaborative research and development arrangements was primarily due to a decrease in reimbursed Drug Manufacturing Activity related to our partnership with AstraZeneca.

Thanks, Joe So and good afternoon, everyone.

I'll begin with the general overview of the third quarter financial results and then also touch.

On the recent realignment that we announced in July .

Total revenue for the third quarter was.

867000, compared to 2 million for the same period in 2018.

Total operating expenses were 24.8 million for the three months ended September Thirtyth 29 team compared to 28.6 million for the same period last year.

The year over year decrease in revenue under collaborative research and development arrangement was primarily due to a decrease in reimbursed drug manufacturing activities related to our partnership with Astra Zeneca.

Peter D. Kies: Inovio's net loss for the quarter was $23.1 million, or $0.23 per share, basic, and 25 cents per share, fully diluted, which compares to $25 million, or $0.27 per share, basic and dilutive, for the same period last year. As of September 30th, 2019.

Inovios net loss for the quarter was 23.1 million.

Or 23 cents per share basic and 25 cents per share.

Fully diluted.

Which compares to 25 million or 27 cents per share basic and diluted for the same period last year.

As of September Thirtyth, 2019, cash and cash equivalents and short term investments were 93.8 million compared to 81.2 million as of December 30, Onest 2018.

Peter D. Kies: Cash and Cash Equivalents and Short-Term Investments were $93.8 million, compared to $81.2 million as of December 31, 2018. In August, Inovio closed a private placement of 1% convertible debt due 2024 with an aggregate principal amount of 18 billion Korean won, or approximately 15 million U.S. dollars, issued to a group of institutional investors led by Korea Investment Partners. These bonds are convertible into Korean Depository Receipts, or KDRs, and, assuming Inovio has completed a secondary listing of its security, on the COSDAQ mark of the Korean Stock Market Exchange, in the form of KDRs or otherwise shares of common stock if KDRs are not listed at the time of conversion. Net proceeds from the offering were approximately $14.5 million after deducting offering expenses payable by Inovio.

In August Inovio closed the private placement of 1% convertible debt do 2024 with an aggregate principal amount of 18 billion Korean won or approximately 15 million us dollars.

Issued to a group of is institutional investors led by Korea investment partners. These bonds are convertible into Korea.

Into Korean depository receipts or Kt ours.

Assuming inovio has completed a secondary listing of it security.

On the Kodak market.

Of the Korean stock market exchange.

In the form of Kt ours, or otherwise shares of common stock. If kt ours are not listed at the time or conversion net proceeds from the offering are offering were approximately 14.5 million after deducting.

Operating expenses payable by Inovio.

Peter D. Kies: In July, the company implemented a strategic cost reduction plan, including a 28% staff reduction and the succession of several R&D and clinical programs, which resulted in an approximate 25% reduced annual burn rate. The reallocation of resources focuses the company's commercialization efforts for its lead asset, 3100, while also developing high-value fast-to-market HPV product candidates, such as INO-3107 to treat RRP and INO-5401 to treat As a reminder, you can read the details of our 10-Q at EDGAR on the SEC website. Also, our financial statements for the third quarter of 2019 can be found in today's press release and in our Form 10-Q filed with the SEC. This can also be accessed on our webpage under Investor Relations, financial reports. With that, I'll turn it back to you, Joseph. Thanks, Peter.

In July the company implementing strategic cost reduction plan, including a 28% staff reduction.

And secession of several R&D and clinical programs, which resulted in an approximate 25% readout reduced annual burn.

The reallocation of resources focuses the company's commercialization efforts.

For its lead asset 3100, while also developing high value fast to market HBV product candidates, such as iron, though 31, no seven to three RP and I know 54, one to treat GBM.

As a reminder, you read the details of our 10-Q.

The Edgar on the FCC website also our financial statements.

The third quarter of 2019 can be found in today's press release and in our Form 10-Q filed with the FCC. This can also be accessed on our web page under Investor Relations.

Financial reports with that I'll turn it back to you Joseph.

Thanks Peter.

Dr. J. Joseph Kim: Before we take your questions... I think it's really important to reiterate that next year stands as a transformative period for Inovio. This time next year, we could have multiple clinical and business development milestones across many therapeutic areas. Within the next 12 months, we're about to unveil significant game-changing data on VGX 3100, INO5401, and MEDI-0457, while working vigorously to see if we can potentially have INO3107 leapfrog them all to the market. We have been working very diligently to get to this moment. I would especially want to thank our dedicated employees, our collaborators, and our long-term shareholders for their faith and conviction. Now, I look forward to taking your questions. Operator, please open the line for the analysts.

Before we take your questions I think it's really important to reiterate that next year stands at a transformative period for Inovio.

This time next year, we could have multiple clinical and business development milestones across many therapeutic areas.

Within the next 12 months, we're about to unveil significant game changing data on VGX 3100, iron ore 54, one and Mehdi 0457.

While working vigorously to see if we can potentially have iron ore 31 off seven leap frog them all to the market.

We have been working very diligently to get to this moment.

I would specialty want to thank our dedicated employees and our collaborators and our long term shareholders for their faith and conviction.

Now I look forward to taking your questions. Operator, please open the line for the analysts.

Ladies and gentlemen at this time will begin the question area and answer session to ask a question you can press Star then one using touched on telephone if you are using a speaker phone. When you ask that you. Please pick up your handset before pressing the keys to ensure the best sound quality.

Operator: Ladies and gentlemen, at this time, we'll begin the questionnaire and answer session. To ask a question, you can press star and then one on a touch-tone telephone. If you are using a speakerphone, we do ask that you please pick up your handset before pressing the keys to ensure the best sound quality.

Operator: To withdraw your questions, you may press star and two. Again, that is star and then one to ask a question. We will pause momentarily to assemble the roster. Our first question comes from Charles Duncan from Cancer Fitzgerald. Please go ahead with your question. Hi, this is Pete Stobopoulosan from Cancer Fitzgerald. Congratulations on the quarter. How are you? Congratulations on the quarter and...

To withdraw your questions you May press star and too.

And that is star and then one to ask a question.

We'll pause momentarily to assemble the roster.

Our first question comes from Charles Duncan from Cantor Fitzgerald. Please go ahead with your question.

Hi, This is our pizza Buffalo some for Charles.

Congratulations order how are you.

Okay got you listed on the quarter and.

Operator: This is based on the GBM data that you presented last week.

Solutions on the GBM data that you presented last week.

Dr. J. Joseph Kim: I know that you mentioned Apollo's bio in your prepared remarks, but I'm not sure if I missed something. So last quarter, you mentioned that they filed an IND with the Chinese FDA. So has there been a response from the Chinese FDA? And have they started to explore opening clinical sites in China? I'll go up with the recruitment and reveal, too.

I know that.

Mentioned the Apollo.

Remarks, but I'm not sure or something.

So last.

What are you mentioned that the fall denying b.

China FDA so.

Has there been response from the terms of FDA and have decided to explore opening clinical sites in China.

With of the recruitment revealed so.

Yeah, So China, Sta, or MP and May have.

Dr. J. Joseph Kim: Yeah, so the Chinese FDA or MPMA has accepted the IND from Apollo Bio. We're taking many steps with Apollo Bio to open the trial for VGX 3100 in China. The details we can't really discuss at this moment, but you can be assured that the China plan will be executed fully in 2020 by Apollo Bio for VGX 3100. All right, thank you. And one question about the biopsy of these companion diagnostics for VGX 3100. Just so that I sort of get a better understanding, is this completely in QIAGES' hands beyond you providing the reveal samples? And will Inovio or QIAGEN OPAC work better?

Accepted the idea of bio.

We're taking many steps with Apollo to open the trial.

For VGX 3100, and China the detail so we can't really.

Discuss at this moment, but you can be assured that.

China plan, all will be executing full in 2020 by Apollo bio for VGX 3100.

Thank you and the one question about the other biopsy companion diagnostic grew up 3100.

Just so that sort of get a better understanding is completely in cardiac and beyond you providing reveal samples and though we will inovio origin rights and we'll be sharing revenues.

Dr. J. Joseph Kim: All right.

Dr. J. Joseph Kim: and Willoughby's Share of the Revenues.

Yes, so it's a co development.

Dr. J. Joseph Kim: Yeah, so it's a co-development collaboration field. A lot of the early development work has been done, and then QIAGEN brings their commercialization and execution excellence. This is what they do; they develop and sell diagnostic kits. So our goal is to have this complementary kit available as a pre-treatment biomarker-based kit that can help us guide and the doctors and the patients guide the usage of VGX3100, where the patients who can benefit the most will use VGX 3100, and that has huge implications for us. Charge more, we can have patients have better overall efficacy, so it has multiple positive effects It would improve overall health care dollars as well because we can have this targeted usage of 3,100 in patients who value them the most. So I think the key is to really utilize Inovio's expertise and QIAGEN's expertise and make this combination possible. We'll provide more information as we advance this further in 2020, and we're making great progress right now.

Collaboration steel.

Lot of the early development work has been done and then quite Jim brings their commercialization and execution excellence.

Yes. They this is what they do they develop and so diagnostic kits. So our goal is to have this complementary kit.

Available as a pre treatment biomarker based kit that can help us guide and the doctors and patients guide the usage of VGX 3100.

Where the patients who can benefit the most.

Well use VGX 3100, and that is huge implications for us for Ken.

Charge more we can have patients have better overall efficacy. So it has multiple positive effects.

It would improve overall to the health care dollars as well because we can have this targeted usage of 3100 in patients who value. The most so I think the key is two to really utilize inovios expertise and quadrants expertise.

And really making this combination possible will provide more information as we advance this further and 2020.

And.

We're making great progress right now.

Alright, Thank you very much in my congrats on the quarter.

Dr. J. Joseph Kim: All right. Thank you very much. And congratulations on the quarter again. Thank you, Pete.

Thanks Pete.

Operator: Our next question comes from Joel Beatty from Citi. Please go ahead with your question. Hi guys, this is Sean Egan, owner of Juul. Thanks for taking my question.

Our next question comes from Joel Beatty from Citi. Please go ahead with your question.

Hi, guys. This is Sean Egan on for Joel Thanks for taking my question.

Operator: Hi Sean. Hi.

Perfect.

Dr. J. Joseph Kim: Hi Joseph. A few for me today. The first one on 5401, your Global West OMO Program. Maybe if you could just talk at a high level about the next steps, like do you plan on waiting until the full OS data matures kind of prior to making any decisions on a path forward, or maybe any high-level thoughts on what a pivotal design could look like? And then I have a follow-up appointment as well.

A few for me today. The first one on 54 Ahwahnee Rogrio Westell more program, maybe just talk I got a high level. What next steps are like do you plan on waiting till the full OS data matures.

Prior to making any decisions on a path forward or maybe on a high level thoughts on what a pivotal line could look like and then I've a follow up as well.

Dr. J. Joseph Kim: Yeah, so I'm going to turn it over to Jeffrey for a detailed answer, but the really big picture is that we're very excited about the early data, and we're beginning to imagine and draw out what a pivotal trial could be. Obviously, as we see the later survival data, we would be even more ecstatic. So I'm going to turn it over to Jeffrey for any additional insights.

Yeah, So I'm going to turn it over to Jeff free for Ditto answer, but top really picked picture is we're very excited about the early data and we're beginning to imagine and draw out what a pivotal trial could be obviously.

So we see the later.

Survival data, we will be even more exciting so I'm going to turn over to Jeffrey for any additional sites insights.

Dr. J. Joseph Kim: Thanks, Joseph. And thanks, Sean, for the question. Exactly.

Thanks, Joseph and thank shown for the question exactly so.

Dr. J. Joseph Kim: So we'll be looking, as Joseph has said, to the middle of next year and then into the third and fourth quarters of next year for our overall survival data. And that, together with what we continue to learn from the current study, will help us inform the design of our next trial. But obviously, as you can imagine, we've certainly already put time and effort into thinking where we'd like to move this opportunity and potentially what that design would look like. So we look forward to the overall survival data for next year, which we're extremely excited to see. Thanks, Jeff. And then, also, in regards to the diagnostic from QIAGEN, are there any learnings that you could leverage that could be broadly applicable across your platform, or are those really tailored to VGX 3100?

And we'll be looking it's just of the said to the middle of next year, and then into the third and fourth quarter next year for our overall survival data.

And that together with what we continue to learn from the current study will help us inform the design of our next trial, but obviously as you'd imagine we've certainly already put time and effort into thinking where we'd like to move this opportunity and potentially what that design would look like so we look forward to the overall survive.

Well data into next year, which were extremely excited to see.

Thanks, Jeff and then a follow up often regard for diagnostic from college and are there any learnings that you could leverage to you know that could be broadly applicable across your platform or are those really tailored to.

The VGX 3100.

Dr. J. Joseph Kim: Um, yeah. But the details have to be studied further, but we think there are lessons. There could be, certainly across the HPV space, and certainly impact our I.O. programs as well. So, you know, the biomarkers and focus. Targeted therapies for I.O. This really is the next generation of improvements in this field. So we're going to apply everything we learned from all aspects, but especially from the biomarker work, to make our programs better.

Yes.

So, but the details have to be study further, but we think there our learnings there could be certainly across HPV space.

And certainly impact into our I O programs as well.

So the Biomarkers and focus.

Targeted therapies for Io really is the next generation improvements in this field so.

We're going to apply everything we've learned from all aspects for especially in the biomarker work.

To make our programs better.

Thanks, Joe if I can I just have one last question I noticed on clinical trials dot Gov that.

Dr. J. Joseph Kim: Thanks, Joseph. And I just have one last question. I noticed on clinicaltrials.gov that the Daratumumab Medi-0457 study decreased enrollment down to 35 from 50. Can you comment on any rationale for that or whether that is in AstraZeneca's hands?

There are two of 'em, Mehdi or four or five seven study.

Decrease enrollment down to 35 from 50 can you comment any rationale for that or.

With that and after that.

Yeah, well, it's really an Astra zeneca his hands, but we see the positives that.

Dr. J. Joseph Kim: Yeah, well, it's really in AstraZeneca's hands, but we see that as a positive, that they have enough patients to look at what they want. And based on what's publicly stated on ClintonTrials.gov, they're looking to fully close out the study by the third quarter next year. And we're expecting, we're sort of estimating, because they have the full say on when and where to present the head and neck cancer data. But we're thinking sometime mid-year next year, give or take a couple months, is where they would likely present it. So I think that sets up the additional arsenal in our 2020 expectations in terms of meaningful phase two and phase three data in 2020.

They have enough patients.

Look at what they want.

And.

Based on what's publicly stated and club trolls lack of they're looking to fully close out the study by third quarter next year, and we're expecting or sort of estimating because they have the full say and.

When and where to present, the head and neck cancer data. So we're thinking sometime mid year next year.

Give or take couple of months is where.

They would likely present, so I think that sets up the additional arsenal and our 2020 expectations answer in terms of meaningful phase two in phase three data in 2020.

Great. Thanks, so much like color appreciate it.

Dr. J. Joseph Kim: Great. Thank you so much for the call. I appreciate it. Thanks. Our next question comes from Stephen Wiley from Stiefel. Please go ahead with your question. Hi, this is actually Ellen on behalf of Steve.

Thanks.

Our next question comes from Stephen Willey from Stifel. Please go ahead with your question.

Hi, This is actually Allen on for Steve. Thanks for taking our questions. So I think first one just about VGX 3100, I believe the guidance may have changed from here in 19 first quarter 20, and correct me if I am on there and I was just wondering if that is the result, I'm just wanting to present at a specific medical conference in first quarter 20.

Operator: Thanks for taking our questions. So I think the first one is just about VGX 3100; I believe the guidance may have changed from year 19 to first quarter 20. Correct me if I'm wrong there. So I was just wondering if that was a result of just wanting to present at a specific medical conference in first quarter 20, or if it had to do with enrollment dynamics at all. And then also related to that, just wondering what kind of data points we'd be able to expect from this interim update in first quarter 20. Thanks.

Or if it had to do with enrollment dynamics at all and then also unrelated to that just wondering what kind of data points that we'd be able to expect from this interim update enforce kind of 20. Thanks, Yeah, I think you're referring to our phase two been and then Ayn studies for VGX 3100, yes.

Dr. J. Joseph Kim: Yeah, I think you're referring to our Phase 2 VIN and AIM studies for VGX 3100. Yes, you know, the enrollment dynamics were on point and on track. We completed 33 patients in the VIN study and 24 patients in the AIM study. We feel, as you stated,

You know the enrollment dynamics a war on point, then and on track.

We completed the 33 patients and then study and 24 patients and then study a we feel as you stated.

Dr. J. Joseph Kim: to have a meaningful place to present our data. So, there's really not a lot of data presentation opportunities in the late fourth quarter. So, we're going to be doing it at a medical conference in the first quarter next year.

To have a meaningful place to present our data so.

Theres really not a lot of data presenting opportunities in the late fourth quarter. So we're going to be doing it.

Medical conference in the first quarter next year.

Okay, Great and then can you talk about any commercial plans or any specifics you have outside of the diagnostic tool for VGX three 100.

Dr. J. Joseph Kim: Okay, great. And then, can you talk about any commercial plans or any specifics you have outside of the diagnostic tool for VGX 3100 for Reveal 1 and 2, as that kind of gets closer to reading out?

For reveal one and two as that kind of gets closer it out.

Dr. J. Joseph Kim: Yeah, I mean we were very excited about the Reveal 1 data and really that's the next major milestone. We've all been waiting for this for the last couple years, and then Reveal 2 comes after that, and certainly, we have internal preparations for commercialization, launch readiness, and so on. We're talking to multiple interested potential partners who may work with us and all these things we're looking into the future, but we're very excited about what BGX 3100 can do for patients who are suffering with cervical pre-cancer today, where the only treatment option is lofting off the tops of the full top layers of their cervix, negatively impacting their ability to have future children. So, you know, we think we have an immunotherapy So we're quite excited and we think the market will embrace VGX 3100 as an immunotherapy option for cervical dysplasia and certainly for other indications such as bulbar and anal dysplasia as well.

Yeah. When we were very excited about the reveal one data and really that's the next near term.

Data major milestones, we've all been waiting for this for the last couple of years.

And then reveal to comes after that and concern me, we have internal preparations for commercialization.

Launch readiness and so on a we're talking to multiple interested potential partners.

Who may work with us and all these things were looking into the future but.

We're very excited about what Pgx 3100 can do for patients who are suffering with cervical pre cancer today.

Were currently only treatment option. This lofting off the top of full pop layers of their service negatively impacting their ability to to have future baby. So yeah. We can we can we think we have an immunotherapy solutions that can treat the disease clear the.

Caused that the disease and HPV 16, and 18 viruses.

And spare the service from surgery so.

We're quite excited and we think the market will embrace.

Yes 3100.

They immunotherapy option for cervical dysplasia, and certainly to other indications both of our annual dysplasia as well.

Okay, Great and then one last one from me just related to the GBM study and can you just remind us what the bar will be.

Dr. J. Joseph Kim: Okay, great. And then one last question for me just related to the GBM study. Can you just remind us what the bar will be OS-wise to move forward once we see those readouts? Then, additionally, do you think we'll get additional patient baseline data along with those 12- and 18-month OS readouts next year? Thank you.

Slide to move forward I once we see those read outs. Then Additionally, do you think will will get additional patient baseline data along with those 12 and each month last read outs next year. Thank you.

Jefferies.

Thanks for the question Alan So yes, you know in general we would expect to be using standard of care numbers, obviously around Oh, yes, 12 to know as a team and similarly to use median overall survival data based upon the current standards of care.

Dr. J. Joseph Kim: So yeah, you know, in general, we would expect to be using standard of care numbers, obviously, around OS-12 and OS-18, and similarly, to use median overall survival data based upon the current standards of care. And there, again, are several published numbers. We would anticipate that about 60% or so, 50% to 60% of patients will be alive at 12 months with glioblastoma if you look at all comers. And then, obviously, fewer will be alive at 18 months. That could drop to about 40% or 50%.

And there again or several published numbers I would anticipate that about.

60% or so 50% to 60% of patients.

We'll be alive at 12 months with Glioblastoma. If you look at all comers and then obviously fewer to be alive in 18 months that could drop to about 40%, 50%. So we'll continue to follow our data through 12 in 18 months, taking a look at what the standards are.

Dr. J. Joseph Kim: So we'll continue to follow our data through 12 and 18 months, taking a look at what the standards are. Great. And then the patient baseline, do you think there'll be any more information on that? Or will it be limited to what we saw at CITSE?

Great and then the patient baseline.

Any more information on that or a little eliminates what we thought city.

So when you say patient baseline tell me little bit more about what you mean.

Dr. J. Joseph Kim: So when you say patient baseline, tell me a little bit more about what you mean. Yeah, so specifically if patients had a full surgical resection or partial. Sure. So, yeah, we would anticipate that as we continue to publish our data and we have our full data set, you'll get even more information about the baseline for these patients. Again, as you know, all patients, obviously, in the study are newly diagnosed, and all of our data, very importantly, are being calculated from day zero, the first day of our therapeutic intervention.

Yes, it just specifically if patients had a full surgical resection or partial.

Sure. So yes, we would anticipate that as we continue to publish our data and we have our full dataset.

You'll get even more information about the baseline for these patients again as you know all patients obviously in this study our newly diagnosed and all of our data very importantly are being calculated from day zero. The first day of our therapeutic intervention.

Okay, great. Thank you.

Dr. J. Joseph Kim: Okay, great. Thank you. Yep, thank you. Our next question comes from Gregory Renza from RBC Capital Markets. Please go ahead with your question. Hey guys, thanks for taking my question.

Yep. Thank you.

Our next question comes from Gregory Renzo from RBC capital markets. Please your with your question.

Hi, guys. Thanks for taking my question.

Hi, Greg.

Operator: I agree.

Operator: And just to follow up on 5401 and the GBM study, Joseph, in your prepared remarks and subsequent, you mentioned just the concept of working with or finding a global park given the expansion potential. I'm just wondering if you could perhaps just remind us of the agreement and the arrangement you've got with Regeneron on this, and any detail there about future engagement would be helpful. And then I think, similarly, just maybe broadly as well, what you see as sort of the optimal point of engagement for my partner as this program matures and moves forward. Thanks.

Just to follow up on slide 401, and the GBM study Joseph in your prepared remarks, and subsequent you've mentioned just the concept of of working with are finding a global park given the expansion potential just wondering if.

You could perhaps just remind us of the for the agreement and the arrangement you've got with Regeneron.

On this in any detail there about future engagement.

What would be up would be helpful. And then I think similarly, just maybe broadly as well what you see as sort of the optimal points of engagement from from a partner as this program matures into toward thanks.

Yes, you know regeneron has been a great.

Dr. J. Joseph Kim: Regeneron has been a great collaborator in this regard. I say collaborator because it's not a full-blown licensed partnership like the one we have with AstraZeneca for Medi-0457. So, INO5401 has not been licensed to anyone. Now, Regeneron is providing their important PD-1 Lipteo inhibitor, Lipteo, to this study. They also get the benefit of looking at the data, perhaps before everyone else. For that advantage, I think they have some timing, knowledge, and information advantage over other potential partners.

Great collaborator in this regard I'd say collaborator because it's not a full blown license partnership like the one relationship we have with Astrazeneca for many 057. So I know 54, one has not been license to anyone.

No regeneron is providing they're important PD, one lift tail inhibitor, Italy payable to the study.

They also get the benefit of looking at the data, perhaps before everyone else.

For that advantage I think they have some timing and knowledge and information advantage over other potential partners. So, but we have not spoken for a annual 50 412 regeneron.

Dr. J. Joseph Kim: But we have not spoken to Regeneron about INO5401 for GBM or other fields. But obviously, a perfect partner would look a lot like Regeneron and perhaps other big pharmas with their own PD-1 or PD-L1 inhibitors. As we have shown that our immunotherapies are almost equally effective when combined with these PD-1 or PD-L1 inhibitors. Just a reminder, we have PD-L1 inhibitor combination with AstraZeneca in their development for 4-5-7, PD-1 with Regeneron, and our prostate cancer, 51-51, is just entering a combination study with Nivolumab from Bristol-Myers. So I believe our therapies can be effective combined with any of these checkpoint molecules, inhibitor molecules. Someone like Regeneron with a global reach, the goal of applying 54-01 to make the checkpoint inhibitors perform even better compared to the competitors in their space. Without adding any additional toxicity, increasing efficacy is something that we think someone like Regeneron or other big pharmas in this competitive space would be very interested in. And just to take...

For GBM or for other fields, but obviously a perfect partner.

Well look a lot like regeneron and perhaps other big pharma us with their own PD, one or PD L. One inhibitors as we have shown that our immuno therapies are almost equally effective and combining with these PD one or PD. One inhibitors. Just a reminder, we have.

PD, one inhibitor combination with astrazeneca with their development for four or five seven PD one with.

Regeneron and our prostate cancer 51, 51 has just entering a combination study with Nivolumab from Bristol Myers. So I believe our therapies can be effective combine with a new these checkpoint molecules in a bit or molecules.

But you know someone like regeneron with the global reach.

The goal of applying 54 one.

Make the checkpoint inhibitors perform even better.

Perfect, who the competitors in their space.

Without adding any additional toxicity, increasing efficacy is something that we think someone like regeneron or other big pharma.

This competitive space would be very much interested in and just to take share.

Dr. J. Joseph Kim: I mean, I stated in this prepared remark part, but 5401 success in GBM has been a result of, It's great for JVM and for the patients and for Inovio. And that's a great opportunity on its own. But the way we designed this product is it's a multi-cancer targeting product, much like the similarity to NECTAR's program where they can combine and address multiple different cancers. We can do that utilizing very prolific tumor-specific antigens or associated antigens in WT1, HTER, and PSMA. And then we have dozens, dozens more of these novel antigens in our toolbox, which could be utilized to create even more potent cancer immunotherapies to combine with checkpoint inhibitors. So I think we are very excited about the GVM trial on its own, but we have other broader plans, and because our resources are certainly limited as a small biotech, bringing in a global partner that can fully utilize this versatility and potential broad range of efficacy, we think it will be a great partnering opportunity going forward.

Sure Mom and further I mean I stated at this prepared remark part, but 54 one success.

In GBM.

Yes, it's great for GBM and for the patients then for Inovio.

And that's a great opportunity on the sound, but the way we design. This product is say mcpike cancer targeting product much like the similarity to Nexstars program, where they can combine and address multiple different cancers, we can do that utilizing very prolific.

Tumor specific antigen or associated antigens and WT one.

H. turn PS Umang.

And then we have dozens.

Dozens more of these novel antigens in our tool box, which could be utilized to create even more.

Potent cancer Immunotherapies to combine with checkpoint inhibitors, so I think.

We are very excited about the GBM trial on the song, but we have other broader plans and because our resources are certainly limited as a small biotech bringing in a global partner that can fully utilized.

This versatility and and potential broad range of efficacy.

We think a is who would be great partnering opportunities going forward.

Dr. J. Joseph Kim: Great, thank you. And just one more for me on 3100, and as far as the timing, I appreciate you putting a finer point on what we potentially can expect next year. I'm just curious if you can comment a bit on some of the thinking about, you know, having the top-line efficacy data, certainly you've spoken in the past about landing, reveal, one and two planes, if you will, around the same time, but just curious about that cadence by fourth quarter. Would we expect to see some reduction in safety there as well, or would we wait for the full, wait for that following the Thank you.

Great. Thank you and I just one one more for me on 3100.

And on and that's where the timing and I appreciate you, putting a finer point on what we potentially can expect.

Next year I'm, just curious if you comment a bit on some of the thinking about that you know having the topline efficacy data certainly have spoken in the past about landing reveal wanting to claims if you go around the around the same time, but just curious about that that cadence by fourth quarter would we expect to see some kind of safety.

Hi, there as well or we wait for the full wait for that.

Following the full 88 week for Bill one.

Later point thank you.

Dr. J. Joseph Kim: Yeah, great. Thanks for that question.

Yeah, Greg Thanks for that question. So the top line is focused on a group level efficacy results.

Dr. J. Joseph Kim: So the top line is focused on group level efficacy results, and full safety will be after the full 88 weeks for Reveal 1 and full 40 weeks for Reveal 2. Now, these are 198 patients studied.

Both safety will be after the full 88 weeks for reveal one and full 40 weeks for four reveal too now. These are 198 patients study, we did already demonstrate strong safety at a week 36.

Dr. J. Joseph Kim: We did already demonstrate strong safety at week 36 and Week 88 using our 167-patient Phase 2B study, which really is pretty much identical to our Reveal 1 and Reveal 2 studies. And we haven't seen any signals of safety throughout any of our DSMB meetings. So we're quite confident, as we always are with our platform programs across our pipeline. So safety is not a real concern or overly concern for us.

And weak 88, using our 167 patients phase Twob study.

She really has pretty much identical to our reveal one and revealed to study so and we haven't seen any signals of safety throughout.

Any of our the SMB a meeting so we're quite confident as we always are with with with our platform programs across our pipeline. So safety is not a a real concern.

Over overly concerned for us.

Great and then I'm, just perhaps I'm just comment on your level of confidence to adhere to your previously stated.

Dr. J. Joseph Kim: Great, and then perhaps just comment on your level of confidence to adhere to your previously stated prospect of having a BLA filing for 2021. Thank you very much.

Prospect of having it be only filing for 2021, thank you very much.

Dr. J. Joseph Kim: You really, um... It depends on the execution of Reveal 2, because Reveal 01's timeline will support potentially 2021. So we should have more guidance in the future.

Well.

It really.

It depends on the execution of where we feel too.

As reveal one time in line with support.

Potentially 2021, so we should have more guidance in the future.

Thanks, guys appreciate it.

Dr. J. Joseph Kim: Thanks, Joseph. I appreciate it.

Operator: Thanks, Scott. Our next question comes from Chris Raymond from Piper Jaffray. Please go ahead with your question. Good afternoon. This is Nicole Gabreski on behalf of Chris.

Thanks, Greg.

Our next question comes from Chris Raymond from Piper Jaffray. Please go with your question.

Good afternoon, Hi, This is no called the Brzeski on for Chris. So I just had a few questions to the first was on that RP program. So like initiation of the pivotal clinical trial for I know 31 is settling in first half of 20. So if it sounds like you guys. It had discussions with <unk>. So just wondering what stone.

Operator: So, just had a few questions. So, with the initiation of a pivotal clinical trial for INO3107 in the first half of 20, it sounds like you guys have had discussions with FDA. So, just wondering what still needs to be worked out with regulators and if you have any color at this point on endpoints for the trial.

Needs to be worked out with regulators and if you have any color at this point and points for the trial.

So we're still discussing that this that's the orphan.

Dr. J. Joseph Kim: So we're still discussing this as an orphan indication, and we want to be as aggressive in timing and sizing of the studies as well. So we're not yet ready to unveil the overall design and the endpoint shed.

Indication, we want to be us.

Aggressive in timing and and sizing of the studies as well.

So we're not yet ready to unveil the the overall design and the endpoint said, but our overall objective is to use similar to what we had shown in our pilot study.

Dr. J. Joseph Kim: But our overall objective is to use similar to what we've shown in our pilot study, in RRP. By the way, we expect to have a clinical publication in the next few months coming out of this RRP study. But, you know, just using it as an immunotherapy to avoid or delay surgery would be a meaningful clinical endpoint. And while this discussion is still going on with the FDA, I don't want to overstep that, but I can confidently say that we will be starting our RRP trial in the first half of 2020. We've been working to manufacture the clinical product, getting all of our clinical potential PIs motivated and Marshall. So everything is getting prepared behind the scenes. We look forward to sharing more information and more detail in the future.

In our PC.

By the way, we expect to have the clinical publication in the next few months to come out of this RFP study.

But you know just using as an immunotherapy.

To avoid or delay.

Surgery would be in a we think is a meaningful clinical endpoint.

And while this discussion is still going on with the FDA I don't want to over step that but our I can confidently say that we won't be starting.

Our RFP trial in the first half of 2020, we've been working to manufacture the clinical product getting all of our.

Clinical potential P is motivated and Anderson.

And.

Marshall then so everything is getting prepared behind the scene.

We look forward to sharing more information more detail in the future.

Thanks, that's helpful and and then maybe second question you know just after that sees TBM update we went back to the literature I notice that there just seems to be some debate around weather PFS 16, TBM translates to overall survival. So.

Dr. J. Joseph Kim: Thanks, that's helpful. And then maybe a second question. You know, just after the phase two GBM update, we went back through the literature and noticed that there just seems to be some debate around whether PFS6 and GBM translate to overall survival. So just kind of wanted to get your thoughts on this and just what your confidence level is moving forward to the first OS readout next year.

Just kind of wanted to get your thoughts on that and just what your confidence level is moving forward to that first last read out next year.

Well.

Dr. J. Joseph Kim: Well, I can just say the field is split on the predictability of BFS6 for future overall survival. But actually, that's not the point.

I can just say the the field this split on the predictability of PFS six.

To future overall survival, but actually that's not the point I think a the point as.

Dr. J. Joseph Kim: I think the point is, and Jeffrey can add to this, but we're excited about the data we have at six months for progression-free survival. We're not projecting that we're going to be successful in OS, but we are waiting with bated breath. In less than six months from now, we will have OS 12, and less than a year from now, we will have OS 18. So while the previous studies were not able to correlate the success of PFS6 to OS12 and 18, that's not the question we're trying to address. We think we have an immune-activating approach that, combined with a checkpoint inhibitor, brings a better level of efficacy. And if our hypothesis is right, and so far the PFS6 is supporting that, we think we're very confident and highly optimistic about the OS numbers. But by no means are we saying we can correlate and predict success. Jeffrey, would you add any more granularity?

And Jeffrey can add add to this but we're excited about the data we have at six months so for progression free survival.

We're not projecting we're going to be successful in Alaska, but we are waiting with bated breath or.

And in less than six months from now we will have less 12 and less than a year from now we will have all with a team.

So while the previous studies were not able to correlate the success of PFS six to last 12 in 18.

That's not the question we're trying to address so we think we'll have a immune activating approach that combines with checkpoint inhibitor brings better level of efficacy and if our hypothesis right and so far the PFS six is supporting that.

We think we're very confident and and highly optimistic for the whole s. numbers, but by no means are we saying, we can correlate and predict success.

Jeffrey would you add any more blender granularity.

Dr. J. Joseph Kim: Thanks, Nicole, for the question. I completely agree with you, Joseph. I think what we've demonstrated is that we have immune responses to our T-cell enabling therapy and that we have efficacy. And those two things give us the confidence to move on to an overall survival endpoint. And exactly as you said, Joe, I would not prognosticate, but we are very excited to see what our overall survival data look like.

Or.

Thanks to call for the question I completely agree with you Joseph I think what what we've demonstrated is that we have immune responses to our T cell, enabling therapy and that we have an efficacy signal and those two things give us the confidence to move onto an overall survival endpoint.

And exactly as you said Joseph.

I would not prognosticate, but we are very excited to see what our overall survival data looks like.

Dr. J. Joseph Kim: I would say I like their channel.

I would say I like our chances.

Dr. J. Joseph Kim: Great! That's really helpful.

Great that's really helpful. Thank you.

Operator: Thank you. And our final question today comes from Jason McCarthy from Maxim Group. Please go ahead with your question. Hi, good afternoon. This is actually Noreen. I'm on behalf of Jason.

Thanks.

In our final question today comes from Jason Mccarthy from Maxim Group. Please go with your question.

Hi, Good afternoon. This is actually know you don't Ferguson.

Operator: Hi Noreen. How are you?

Hi, how are you.

Dr. J. Joseph Kim: So, congratulations on the GBM data, and actually, I'd like to follow up on a number of those questions. I was just wondering, with regard to the trial design for the GBM study, if we could drill down a little bit there. You know, in clinicaltrials.gov, it says some of the patients received TMZN radiation if it was clinically indicated. But then, when I look back at the poster at CITSE, it suggests that the entire cohort, the methylated cohort, may have received additional TMZ for up to six additional cycles. So, I was wondering if you could provide a bit of clarity on this, if there was a subgroup within cohort B that received additional chemo, or if it was the entire cohort.

Congrats on that GBM data and actually had I'd like to follow up on a number of that was questioned I was just wondering with regards to the trial design for the GBM study, if we could drill down a little bit there you know in the clinical trials Dot Gov. It says some of the patients with Cpms and radiation if it was clinically indicated.

But then when I look back at the poster I did see it suggests that the entire cohort.

The methylated Court mean received additional kimzey up to six additional cycles. So I was wondering if he could provide a better clarity on there since there was a subgroup within the cohort b. They received additional chemo or is it was the anti cohort and if it's not the anti cohort will there be a break down on the data as well and the feature.

Dr. J. Joseph Kim: And if it's not the entire cohort, will there be a breakdown on the data as well in the future? Thanks, Doreen, for the question. So, exactly as you've indicated, all patients on the study, whether they were MGMT-methylated or MGMT-promoter-unmethylated, received three weeks of radiation and three weeks of temozolomide concurrently, and then, exactly as you've suggested, all patients on Cohort B, the methylated, MGMT promoter-methylated patients, went on to receive adjuvant temozolomide for six And then those that were methylated received additional temozolomide for up to six cycles. So this is.

Sure. Thanks during for the question so.

Exactly as you've indicated all patients on the study whether they were MGMT methylated MGMT promoter Unmethylated received.

Three weeks of radiation in three weeks of team has all of my concurrently and then exactly as you suggested all patients on cohort b. The methylated MGMT promoter methylated patients went on to receive Andrew Obin Temozolomide up to six cycles. So again, all patients received radiation and team has all of my.

For three weeks and then those that were methylated received additional temozolomide up to six cycles.

Dr. J. Joseph Kim: This is the standard of care for these populations, so we followed the directions from the FDA and our KOLs, who helped us design the trial and helped us to conduct the trial.

This is the standard of care for these populations. So yeah, we follow the directions from the FDA and our.

Okay wells or who helped US design the trial and helped us to execute the the conduct of the trial.

Yeah that makes sense. Thank you and you know I was just wondering I actually brought this up in the past you know you normally would check points or at least in the past not you know all of them have failed in the past and people have said or.

Dr. J. Joseph Kim: Yeah, that makes sense. Thank you.

Dr. J. Joseph Kim: And, you know, I was just wondering, I actually brought this up in the past, with checkpoints, or at least in the past, not all of them have failed in the past. And people have said or suggested that it's because, you know, there's a need for steroids, and steroids actually decrease the efficacy of a checkpoint. But, you know, in your study, you have these compelling results. So I was wondering, were steroids actually used in the whole population? You know, what percentage of the population, the patient population? And, you know, what are your thoughts on that?

Suggested that it's because you know there's a need for steroids and steroids actually decreased the efficacy of a checkpoint, but you know in your study.

You know you have these compelling results. So I was wondering where steroids actually used and all the population you know what percentage of the population patient population and you know I'm. What are your thoughts on that you know if you know gets platform is actually able to counteract <unk> inhibitory effects of standpoint.

Dr. J. Joseph Kim: You know, if Inovio's platform is actually able to counteract the inhibitory effects of steroid on a checkpoint to promote its activity? Yeah, I was just wondering, you know, as to whether there was steroid use and if you have any thoughts on that. Great question, Jeffrey. Yeah, Noreen, that's a great question.

On a checkpoint to promote its activity yeah. I was just wondering you know as to whether there was never use and if you have any thoughts on that.

Great question, Jeffrey and I mean, that's a great question. So as Josef mentioned when we designed the protocol we worked very closely with our key opinion leaders in the field.

Dr. J. Joseph Kim: So, as Joseph mentioned, when we designed the protocol, we worked very closely with our key opinion leaders in the field, many of whom were and are part of the single-agent checkpoint studies, as you've mentioned, and they themselves have been very disappointed at the data that have come from those single-agent checkpoint studies. We, of course, feel that by combining with a T-cell-enabling therapy like INO5401 plus INO9012, we really give, as Joseph has said before, a one-two punch to the tumor, increasing the opportunity for epigenetics. But to your point, steroids certainly can be.

Many of whom were and are part of the single agent checkpoints studies as you've mentioned and they themselves have been very disappointed at the data that have come from those single agent checkpoint studies, we of course feel that combining with the T cell, enabling therapy like Dyno 54, one plus.

Yes, I know 90, 12, we really give as just have a said before one two punch to the tumor increasing the opportunity for efficacy.

But to your point steroid certainly can be suppressive in generating an immune response and so we did pay attention to the amount of steroids that was used and our study does control for and collect that information and those data show.

Dr. J. Joseph Kim: It's impressive in generating an immune response, and so we did pay attention to the amount of steroid that was used, and our study does control for and collect that information. And those data should be forthcoming in an upcoming scientific presentation when we bring all those data together. That's great to hear. And just one more follow-up, you know, again on the GBM study: there's been some suggestion that checkpoints may actually work better in the neoadjuvant setting. So I know it's thinking far ahead, but, you know, have you also considered a potential similar study with INO5401 in such a setting? That's an outstanding question.

Would be forthcoming in an upcoming scientific presentation, when we bring all those data together.

Okay, that's great to hear and just one more follow up yeah. It again on the GBM study you know there's been some suggestion that checkpoints me actually work better in the Neoadjuvant setting. So I know its thinking far ahead, but you know have you also considered a potential similar study with I know 54, one in such a set.

Yes, that's an outstanding questions. The short answer is.

Dr. J. Joseph Kim: The short answer is, of course, we are paying attention very closely to the literature. And, as you are aware, there have been recent several publications looking at neoadjuvant checkpoints in GBM. And fortunately, the authors of one or more of those papers are KOLs that we have the opportunity to interview.

Of course, we are paying attention very closely to the literature and.

I see as you are aware there have been recently several publications looking at Neoadjuvant checkpoint in GBM and thankfully the authors of one or more of those papers R.K. wells that we have the opportunity to interface with so we're excited to see the data from this trial and we keep all opportunities open based.

Dr. J. Joseph Kim: So, you know, we're excited to see the data from this trial, and we keep all opportunities open based upon the emerging literature and the science. Great, and thank you for answering my questions, and congratulations on the progress. Thank you so much. Thank you. And ladies and gentlemen, with that, we'll conclude today's question and answer session. And at this time, I'd like to turn the conference call back over to Joseph Kim for any closing remarks.

Upon the emerging literature and the science.

Great and add it. Thank you for answering my questions and congrats on the progress.

Thank you so much thank you.

And ladies and gentlemen, without will conclude today's question and answer session and at this time I'd like to turn the conference call back over to Joseph Kim for any closing remarks.

Dr. J. Joseph Kim: Thank you very much. 2020 is going to be awesome. Stay tuned.

Thank you very much 2020 is gonna be awesome.

Stay tuned thank you.

Ladies and gentleman that will conclude today's conference call you. Thanks for attending today's presentation. You may now disconnect your lines.

Operator: Ladies and gentlemen, that will conclude today's conference call. We do thank you for attending today's presentation. You may now disconnect your lines.

Hi.