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PDS Biotechnology Corporation (PDSB)

Q2 2020 Earnings Call· Thu, Aug 13, 2020

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Transcript

Operator

Operator

Greetings, and welcome to PDS Biotechnology's Second Quarter 2020 Financial Results. At this time all, participants are in a listen-only mode. [Operator Instructions] As a reminder, this conference is being recorded. I would now like to turn the conference over to your host, Deanne Randolph, Investor Relations.

Deanne Randolph

Analyst

Good morning, and welcome to PDS Biotechnology's second quarter 2020 earnings conference call and audio webcast. With me today are Dr. Frank Bedu-Addo, Chief Executive Officer; Dr. Lauren Wood, Chief Medical Officer; and Michael King, Interim Chief Financial Officer. Earlier this morning, PDS Biotech issued a press release announcing financial results for the three months ended June 30, 2020. We encourage everyone to read today's press release, as well as PDS Biotech's quarterly report on Form 10-Q, which will be filed with the SEC this afternoon. The Company's press release is available on PDS Biotech's website at pdsbiotech.com, and the quarterly report will be posted later today. In addition, this conference call is being webcast through the Company's website and will be archived there for future reference. Before we begin, I would like to caution listeners that comments made by management during the conference call will include forward-looking statements within the meaning of federal securities laws, including the Safe Harbor provisions of the Private Securities Litigation Reform Act of 1995. These forward-looking statements involve material risks and uncertainties, and the Company's actual results may differ materially. For a discussion of this factors, including among others, the risks related to COVID-19, the impact such a pandemic may have on the Company's business operations, financial operations, and results of operations, and the Company's ability to respond to the related challenges, including those noted in this morning's press release, please refer to PDS Biotech's SEC filings. Investors. potential investors, and other listeners are urged to consider these factors carefully in evaluating the forward-looking statements, and are cautioned not to place undue reliance on such forward-looking statements. In addition, the content of this conference call contains time-sensitive information that is accurate only as of the date of the live broadcast, August 13, 2020. Except it's required by law, the Company undertakes no obligation to revise or update any statement to reflect events or circumstances that take place after the date of this call. Please be advised that since we are in the middle of a previously announced public offering, we will not be taking questions at the conclusion of the call today. Please refer to the prospectus for further information. With that, I would now like to turn the call over to Dr. Frank Bedu-Addo. Frank?

Frank Bedu-Addo

Analyst

Thank you, Deanne, and welcome, everyone, to PDS Biotech's second quarter 2020 earnings conference call. This past quarter, we made significant progress across both our immuno-oncology and infectious disease programs, despite the challenging environment for clinical trial operations, due to the global COVID-19 pandemic. On last quarter's earnings call, we reported that we were planning and looking forward to initiating Phase 2 clinical development of our lead program, PDS0101. We also announced our intention to broaden our infectious disease programs to include the development of vaccines for both COVID-19 and universal influenza. Let me quickly summarize the progress that has been made since our last report. The first of the three planned Phase 2 trial of PDS0101 was initiated in June in advanced HPV-associated cancers, and it's recruiting according to schedule. We announced a clinical collaboration to perform a second Phase 2 study of PDS0101 in advanced localized cervical cancer at the MD Anderson Cancer Center. This trial is due to be initiated in the next few weeks. An award from the NIAID has been granted to fund pre-clinical development of diverse immune-based universal flu vaccines. Promising pre-clinical data from our COVID-19 vaccine has been generated, and discussions with the FDA regarding our data package and clinical strategy have also been initiated. A second COVID-19 vaccine is being developed in partnership with the Brazilian company, Farmacore, with pre-clinical funding received from Brazil's Ministry of Science, Technology, Innovation and Communication. I will now provide you with some detail on our various programs. I'll start with our ongoing oncology activities. In our oncology portfolio, as I mentioned, we were pleased to initiate the first of three currently planned Phase 2 clinical studies of our lead product, PDS0101, focused on the treatment of various advanced HPV-associated cancers. Some of you may be aware…

Lauren Wood

Analyst

Thank you, Frank, and once again, welcome, everyone, to this morning's conference call. As Frank mentioned in his opening remarks, we have made significant progress over the past few months in both our immuno-oncology and infectious disease pipelines. The recent initiation of our Phase 2 clinical study with the National Cancer Institute for our lead candidate, PDS0101, as well as our continued pre-clinical work in COVID-19 and influenza, continue to demonstrate our commitment to building a strong repository of clinical and scientific data on our Versamune platform, while progressing the products through clinical development to successful commercialization. Before I review our recent clinical advancements, I'd like to provide a quick overview of how the Versamune technology platform works. Our product pipeline is based on combining our proprietary Versamune T-cell activating technology with tumor or virus associated proteins to enhance the recognition by the human immune system. Versamune effectively delivers these disease-specific proteins called antigens to the immune system for effective uptake and processing, while simultaneously activating the critical Type 1 interferon immunologic pathway. These two important activities result in a generation of potent disease-specific killer T-cells, as well as neutralizing antibodies. Activated disease-specific T-cells are of critical importance in both immuno-oncology and infectious disease, as these activated T-cells have the ability to identify and kill both cancer cells, as well as virus infected cells, and to provide long-term immune memory. We believe that Versamune overcomes many of the key limitations of current therapeutic and prophylactic approaches in generating these powerful disease attacking killer T-cells. Likewise, Versamune's demonstrated ability to activate the preventative or defensive arm of our immune system by rapidly generating neutralizing antibodies also provides for near-term protection from infectious pathogens. The ability to rapidly generate these broad and potent immune responses that include both killer T-cells and antibodies…

Michael King

Analyst

Thank you, Lauren. I would like to review our financial results for the three months ended June 30, 2020. For the second quarter of 2020, net loss was approximately $2.9 million, or $0.19 per basic and diluted share, compared to a net loss of approximately $3.9 million, or $0.75 per basic and diluted share for the second quarter of 2019. Research and development expenses totaled approximately $1.4 million in the second quarter of 2020, compared to approximately $1.9 million in the same period in 2019, a decrease of 26%. For the second quarter of 2020, G&A expenses were approximately $1.5 million, compared with approximately $2.4 million for the second quarter of 2019, a decrease of 38%. Total operating expenses for the second quarter were approximately $2.9 million, compared to total operating expenses of approximately $4.3 million for the same period in 2019, a decrease of 33%. As of June 30, the Company's cash balance was approximately $16.9 million. In addition, on Tuesday this week, we announced pricing of a previously announced underwritten public offering, consisting of six million shares of common stock at a public offering price of $2.75 per share. The gross proceeds from this offering are expected to be $16.5 million before deducting underwriting discounts, commissions, and other offering expenses. In addition, we've granted the underwriter, Oppenheimer and Co., a 30-day option to purchase up to 900,000 additional shares of common stock at the public offering price, less the underwriting discounts and commissions. This offering is closing today, subject to customary closing conditions. Because Biotech intends to use the proceeds from this offering to fund working capital and general corporate expenses, as Frank mentioned earlier, we expected this will provide us with the necessary financial resources to advance all three currently planned PDS0101 Phase 2 clinical trials through initial human clinical data. This concludes our financial statements. I would like to hand the call back to Frank for final remarks. Frank?

Frank Bedu-Addo

Analyst

Thank you, Michael. Before we end the call, I would like to thank our dedicated team and clinical partners for all their work over the past quarter. The initiation of a Phase 2 trial, in partnership with the National Cancer Institute, and the upcoming Phase 2 clinical trial at MD Anderson Cancer Center continue to validate our novel Versamune platform in the field of immuno-oncology. In addition, the recent grant from the NIAID for the development of a universal influenza vaccine and the financial support our partner, Farmacore, has received for the pre-clinical development of the COVID-19 vaccine will help us to advance those programs rapidly towards human clinical trials. Over the coming months, we look forward to reinitiating our Phase 2 combination trial of PDS0101 and Keytruda, addressing first line treatment of recurrent or metastatic HPV positive head and neck cancer. We also look forward to advancing our COVID-19 vaccine programs into clinical trials. The recent fund raise provides us with the financial resources to progress the development of our PDS0101 programs through initial Phase 2 data. Over the next six to 18 months, we also aim to progress at least one of our infectious disease pipeline products into human clinical trial. We aim to work diligently to deliver on multiple clinical milestones, and thank our shareholders for their continued support. That concludes our prepared remarks. Thank you very much for joining us today. End of Q&A: This concludes today's conference. You may disconnect your lines at this time. Thank you for your participation.