Inovio Pharmaceuticals, Inc. (INO) Presents at H.C. Wainwright 24th Annual Global Investment Conference (Transcript)

Inovio Pharmaceuticals, Inc. (NASDAQ:INO) H.C. Wainwright 24th Annual Global Investment Conference September 12, 2022 7:00 AM ET

Company Participants

Jacqueline Shea – President and CEO

Conference Call Participants

Brooke Katsof – H.C. Wainwright

Brooke Katsof

Good morning, everyone and thank you for joining the H.C. Wainwright 24th Annual Global Investment Hybrid Conference from September 12 to the 14, 2022. My name is Brooke Katsof and I’m an H.C. Wainwright analyst. While we are hybrid this year, we’re confident we are going to be able to provide value to you with over 550 companies presenting at this conference and multiple sector tracks devoted to Life Sciences cryptocurrency, blockchain and fintech technology, media and telecommunications, clean tech metals and mining and growth.

H.C. Wainwright is a full service investment bank dedicated to providing corporate finance strategic advisory and related services to public and private companies across multiple sectors and regions. We have a total of 26 publishing senior analysts and over 643 companies covered across all sectors. Please visit each hcw.co.com for more information. Please join us for one-on-one meetings, corporate presentations and panels that will be available live and streaming on September 12 to the 14.

With that said, have a productive and enjoyable day and I’d like to introduce our first presenter. I’d like to welcome Jacquie Shea, who’s the President and CEO of the Inovio Pharmaceuticals.

Jacqueline Shea

Thank you, Brooke. Good morning and thank you for joining in Inovio’s corporate presentation at the H.C. Wainwright Global Investment Conference. Today’s presentation is being recorded on [September 7], 2022. I will be making forward-looking statements regarding future events and the Company’s future performance. These statements are based on beliefs and expectations of today and actual events or results could differ materially.

Inovio is a DNA medicines company. All of our product candidates are based on our DNA medicines platform technology. At the end of the second quarter on June 30, we reported cash and short-term investments of 348 million and minimal debt of 16.5 million. We believe this will support the Company’s operations into the third quarter of 2024, primarily helping fund the strategic development of our key late-stage product candidates, but also helping to advance our earliest stage pipeline as well.

We believe we have a number of key strengths including a versatile technology platform that has solid patent protection, a diversified pipeline of product candidates that are targeting important diseases with high unmet needs, and an experienced management team who is focused on delivering the promise of DNA medicines to the market. The Inovio team has been hard at work delivering on our mission to bring DNA medicines to the market.

In 2022, our efforts to advance this goal have included building our executive team and R&D leadership, with the addition of Dr. Michael Sumner as our Chief Medical Officer, and more recently adding to Mike’s team a new VP of Clinical Development. So far this year, we’ve also shifted gears in response to the ever changing COVID-19 pandemic marketplace by advancing a heterologous booster strategy. We also presented encouraging data from our Phase 1/2 trial evaluating the safety and efficacy of INO-5401 plus INO-9112 in combination with Regeneron Libtayo, when treating patients with glioblastoma at the ASCO annual meeting.

With respect to human papillomavirus or HPV franchise, we have amended the trial design of REVEAL 2 a Phase 3 trial for our DNA medicine VGX-3100 in patients with cervical high grade squamous intraepithelial lesions or HSIL caused by HPV 16 and/or 18 types to revise the primary analysis population from all-comers to a biomarker positive population. We are expecting data from REVEAL 2 either late this year or early next year. We also expect data from Phase 1/2 trial with our product candidate INO-3107 and patients with recurrent respiratory papillomatosis or RRP caused by HPV type 6 and/or 11 in the second half of this year.

Now, I’d like to highlight for years some of the key features of our DNA medicines platform. Our product candidates are optimized DNA plasmids to deliver through our investigational proprietary smart devices called CELLECTRA. The CELLECTRA family includes CELLECTRA 5PSP, CELLECTRA 2000 and CELLECTRA 3PSP. The 3PSP is our next generation intradermal device that will replace CELLECTRA 2000 and is designed for mass administration.

In clinical trials to-date, our DNA technology has elicited balanced antibody and T-cell responses to a wide-range of targeted antigens. An antigen is a fragment of a pathogen or a cancer cell that induces an immune response within the body. Our particular importance is the ability of our DNA medicines platform to drive T-cell responses in a variety of clinical scenarios. T-cells are a part of the immune system that destroy infected or cancerous cells. T-cells may also play an important role in the prevention of severe disease caused by pathogens as well as inducing cell death of cancer cells.

Specifically, Inovio’s product candidates make antigen specific activated CD4+ and CD8+ T-cells including cytotoxic CD8 T-cells, as well as antigen specific antibodies across programs directed against a wide range of cancers and infectious diseases. A single DNA medicine can target multiple antigenic sequences by combining different optimized plasmids within a single dose vial. This approach may widen our market potential and may provide protection against antigenic drift in both viruses and cancer cells.

In various clinical trials, we have administered over 15,000 doses of DNA medicines to more than 5,000 individuals. To date, our DNA medicines have been shown to be well tolerated. DNA medicines do not induce an anti-vector response, giving us the ability to re administer and boost repeatedly and service boosts for other modalities.

DNA medicines also do not use chemical or other adjuvants, they are comprised only of plasmids, water and the low concentration of salts. Our DNA medicines in development at temperature stable, and do not require ultra cold chain transport or storage. They can also be stored at room temperature for at least six months. Like other nucleic acid based medicines, DNA medicines can be rapidly designed and manufactured.

Inovio’s DNA technology can target nearly any disease or condition by encoding to the appropriate antigen leading to the production of antibodies and T-cells. Our DNA medicines platform is comprised of two components, plasmid design optimization, and our proprietary delivery technology.

Our platform consists of six steps. We identify diverse strains or variants of a target pathogenal cancer. We then assess the gene sequence of the selected antigen from chosen strains or variants of the pathogenal cancer. We design an optimal consensus sequence for the selected antigen, using our proprietary algorithm. We insert the optimized sequence for each selected antigen into our plasmid backbone to construct a precisely designed plasmid.

We then manufacture the DNA medicines and deliver them into muscle or skin cells using our investigation on proprietary smart device CELLECTRA. Cells within the body then become antigen producing factories, which are intended to generate a balanced immune response including CD8 T cells as well as antibodies. So let’s spend a little bit more time on how our proprietary CELLECTRA device works to potentially improve immune responses.

Firstly, it’s important to point out that, all DNA medicines are large molecules that require a delivery mechanism in order to be transported into the cell sufficiently. Our solution to this delivery challenge is electroporation. Our investigational proprietary smart device generates brief electrical pulses that open up the cells to allow the DNA medicine to enter and then be processed within the cells to generate the desired immune response.

We have conducted studies that have shown that electroporation can improve the cellular uptake of DNA medicines. On the right side of this slide, you’ll see a study, where we deliver green fluorescent protein into rapid muscle with and without electroporation. The ability of our CELLECTRA device to increase cellular uptake of the DNA plasmids including green fluorescent protein can clearly be seen. Likewise, we believe our CELLECTRA delivery device can effectively deliver our precisely designed plasmids, into cells within the human body to elicit immune responses.

As I mentioned earlier, we have a diversified portfolio of product candidates that targets a number of diseases with high unmet needs that span medical research areas and range from very early stage development to later stages of product development. Our product candidates tend to focus on infectious diseases or cancer because we believe DNA medicines can harness one’s natural immune system to fight these types of illnesses. In the following slides, I’ll highlight a few of our key programs that demonstrate how DNA medicines can work to fight disease.

Earlier this year, we’ve revised our focus for our COVID-19 vaccine candidate INO-4800 to pursue the development of the heterologous booster strategy in responses to changes in the global COVID marketplace, and a waning demand for primary serious vaccine regimens. Heterologous boosting is where a different vaccine is used for a booster dose following the primary regimen. As compared to homologous boosting where the same vaccine is used for booster dose as the primary regimen.

Recent multiple publications indicate that heterologous boosting generates more robust immune responses than the homologous boosting and might enhance protection. Having multiple types of vaccines, including a DNA vaccine like INO-4800, available to the medical community could be a benefit to health globally. The key features of DNA medicines platform mentioned earlier in the presentation provide a strong rationale as to why INO-4800 makes a viable booster candidate for COVID-19. These features include cross reactive T cell responses to provide protection against variants.

The ability to be re administered with a favorable tolerability profile and temperature stability for transport, storage, and distribution. We await the final data analysis from a heterologous boost trial with INO-4800 being conducted by our partner Advaccine in China. This non-inferiority trial is evaluating INO-4800 as a booster by measuring immune responses in participants, who have received an inactivated COVID-19 vaccine and comparing them with the immune responses generated by a homologous boost within an inactivated vaccine.

We expect to share the unblinded antibody data from the trial later this year. In addition, INO-4800 was selected to be evaluated as a primary vaccination regimen in the WHO Solidarity trial vaccines, which is designed to evaluate the efficacy and safety of new cancer vaccines for COVID-19. As you will have seen in our pipeline slide, we have an entire category dedicated to HPV associated disease. HPV is an infectious disease that can progress to cancers as well as other debilitating and life-threatening conditions.

For a number of years, Inovio has been investigating the ability of DNA medicines to prevent and/or treat a number of HPV conditions. One of these product candidates is VGX-3100, which targets HPV 16 and 18 types and is designed to treat cervical HSIL. VGX-3100 is currently being investigated in a Phase 3 trial called REVEAL 2. Last quarter, we amended the trial to revise the primary analysis population from all-comers to a biomarker positive population.

The last patient visit for REVEAL 2 is slated for this month, and we expect to report efficacy and safety follow-up data through week 40 later this year or early next year. Earlier this year, the FDA recommended that we use REVEAL 2 as an exploratory study to evaluate the biomarker selective population and then conduct one or two additional well-controlled trials in the biomarker positive population to support our marketing application.

Analyzing the data from REVEAL 2 will be critical when determining the next steps especially given this feedback from the FDA. Another HPV area of focus for our DNA medicines technology is recurrent respiratory papillomatosis or RRP, a debilitating and rare disease caused primarily by HPV type 6 and/or 11. There are currently an estimated 3,000 new cases a year in the U.S. in adults and children.

RRP is characterized by the development of small wart-like growths or papillomas and the respiratory tract. Papillomas can develop anywhere along the respiratory tract, but most often involve the larynx and the vocal cords. In general, papillomas non-cancerous but in extremely rare cases they can become cancerous. However, even non-cancerous papillomas can cause severe life-threatening airway obstruction and respiratory complications. In RRP, the papillomas have a tendency to grow back after they have been removed surgically, which is the current standard of care.

There is no drug therapy currently approved for patients with RRP. Our interest in RRP began with a small pilot study conducted in two patients, where our DNA medicine product candidate showed the potential to provide a clinical benefit and an alternative to surgery. This works that the development for INO-3107. INO-3107 is our DNA medicines candidate to treat our RRP.

It received orphan drug designation from the FDA in 2020 and is currently undergoing evaluation within a 32 participant Phase 1/2 open label multicenter clinical trial to assess its safety and immunogenicity as well as its ability to reduce the number of surgical interventions, and RRP patient might need to control the advancement of their disease. Enrollment in the trial was completed in the fourth quarter of 2021, and we expect to be able to share data from the trial before the end of the year.

Now let’s move to oncology and a combination trial in newly diagnosed glioblastoma or GBM. INO-5401 is the DNA medicine composed of three different plasmids that encode for tumor associated antigens, hTERT, WT1 and PSMA. INO-9012 is a DNA plasmid that encodes for human interleukin 12, which we believe can further increase the immune response of INO-5401 alone.

In a novel combination Phase 1/2 trial, we evaluated the safety tolerability and immunogenicity of INO-5401 and INO-9012 in combination with Libtayo, Regeneron’s PD-1 checkpoint inhibitor, plus radiation and temozolomide. We recently announced additional survival results from the combination trial at the 2022 ASCO Annual Meeting. 52 patients with newly diagnosed GBM were involved in the trial.

Median overall survival from methylated patients Cohort A were 17.9 months, while median overall survival data in MGMT methylated patients or Cohort B was 32.5 months. The survival data for Cohort A and Cohort B compared favorably to historical survival results are 14.6 to 16 months and 23.2 to 25 months respectively.

Overall, INO-5401 and INO-9012 were observed in the trial to have favorable tolerability and immunogenicity when administered with Libtayo and radiation and temozolomide to newly diagnosed GBM patients. As concluded in the abstract, INO-5401 plus INO-9012 elicited robust immune responses that may correlate with a potentially enhanced survival when administered with Libtayo and radiation and TMC to newly diagnosed GBM patients.

We remain encouraged with the progress to date from this novel combination therapy trial. And our goal is to build upon INO-5401’s ability to elicit antigen specific T-cells that can infiltrate tumors and potentially improve patient survival within a combination regimen. We also have several other infectious disease vaccine candidates and development, all of which are externally funded. Patient enrollment is complete for three different studies.

Our Phase 1b trial for Lassa fever, our Phase 2 trial for MERS and our Phase 1 trial with our Ebola vaccine booster candidate, we expect data from all of these studies later this year. And finally, I’d like to discuss the latest advancement of our DNA medicines platform, DNA encoded monoclonal antibodies or dMAb use DNA plasmids that encode for a specific antibody to leverage the human body’s own cellular machinery to produce the target antibody to potentially prevent and treat infection

dMAb represents a potentially transformative approach for the prevention and treatment of infectious diseases and cancer. We are pleased to be working with the Westar Institute, AstraZeneca, The University of Pennsylvania and Indiana University to develop an anti-SARS-CoV-2 specific dMAb. This product candidate could offer versatile capabilities to function as both a therapeutic and preventative treatment for COVID-19. This Phase 1 open label 24 participant trial is funded by the U.S. Defense Advanced Research Projects Agency Joint Program Executive Office.

I would like to close my remarks today by restating that Inovio is working hard to deliver on its mission to bring DNA medicines to market. With an extended cash runway and an experienced management team, we are developing a promising pipeline of DNA medicines with several important upcoming milestones, including data from the INO-4800 heterologous boost trial conducted by our partner Advaccine. The REVEAL 2 data for VGX-3100, which is expected neither the fourth quarter of this year or first quarter of next year, our RRP 1/2 data, which we expect by the end of this year and data from our IT programs for Lassa, Ebola or MERS all of which we expect to read out later this year.

With that, I would like to thank you for your attention and welcome you to follow the Inovio story as we work to deliver on the promise of DNA medicines. Thank you.

Question-and-Answer Session

Brooke Katsof

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