Q2 2020 PDS Biotechnology Corp Earnings Call

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Quite expressing T cells.

Under this expense expanded collaboration agreement the National Cancer Institute will initially evaluate Pds I want to read in combination with other immunotherapeutic agents in preclinical studies.

With potential progression into human clinical trial under the collaboration agreement.

Our comprehensive strategy of Parker with some of the leading experts in the field of cancer immunotherapy.

Provided us with the opportunity to efficiently expand and progress our Brazilian base oncology pipeline. So it's proved to us efficacy proof of concept in several cancer indications.

As I mentioned earlier.

In addition to the progress made with our immune oncology pipeline. We've also made significant progress with our infectious disease portfolio.

We are taken a very similar partnered approach with expert institutions to efficiently develop a robust pipeline averse immune based preventive vaccines for tuberculosis influenza and cobot 19.

As you may recall.

In February of this year, we announced an amended research and development collaboration between Pts biotech and the Brazilian company Pharmacore.

To develop adverse immune based vaccine for tuberculosis.

Initial vaccine testing has demonstrated promising preclinical results.

Formulation development continues at Tds biotech with further preclinical animal testing to be conducted by pharma coal.

In April we announced that tedious biotech would be expanding our infectious disease pipeline beyond the TD vaccine.

Over the last four months, we have added three vaccines to our infectious disease pipeline of which two out of the three our partner.

Of note is the fact that we are applying our versus new technology platform to the development of what we refer to as a next generation T cell inducing Cobiz 19 vaccine.

Despite the current focus on the development of antibody inducing vaccines.

Recently emerging data on this global pandemic has highlighted the important role of T cells in cobot 19 immunity.

And the importance of developing cobot 19 vaccines capable of generating high level of active.

Virus specific T cells. In addition to neutralizing antibodies in order to potentially achieved more durable protection against covert 19 infection.

We recently reported preliminary preclinical results from our Cobot 19 vaccine candidate Pds owed to all three.

Which demonstrated rapid induction of both killer CDH T cells and helper Cdfour T cells, and addition to neutralizing antibodies.

These strong immune responses occurred within just 14 days of vaccination.

Dr. Lauren World will review the preclinical data for Pds, all two or three in more detail momentarily.

The promising preclinical data or Pds O'toole, three allowed us to initiate discussions with regulatory agencies and receipt free feedback regarding the clinical development plan.

We continue to be engaged in discussions with other government and non government organizations regarding our strategy of applying versus Q2, the development of a simple.

Safe and effective corporate 19 T cell inducing vaccine.

In June we announced the expansion of our development collaboration with Pharmacore to advance Pds owed to open for a second T cell activating next generation Cobot 19 vaccine candidate.

Combining our pursuing platform.

Pharmacore develop novel recombinant source code the two protein.

Under the newly expanded agreement Pearson Pharmacore are working to rapidly accelerate development towards phase one clinical testing in Brazil.

With initial preclinical funding support provided by Brazil's Ministry of Science technology innovation and communication.

We believe this collaboration will allow us to quickly assess the frequency of pds owed to our core to reduce the continuing spread of cobot 19 infections.

I will now switch from Covis to flu.

In June we announced that professor Gerald Woodward collaborator at the University of Kentucky School of Medicine was recently awarded the grant by the National Institutes of allergy and infectious diseases and I think I'd.

Accelerate development of Pds owed to all too.

Averse immune based universal influenza vaccine.

That induces both antibody and T cell responses against multiple strains of the flu virus.

This award provides further validation of the promise of diversity and platform to provide a durable.

Broadly protective and potentially longer lasting vaccine against multiple strains of influenza.

We look forward to continuing our discussions with an I'd as preclinical development work at Pds biotech and the University of Kentucky advance toward three sworn human clinical trials.

We believe that these recent collaborations and government grants provide us with the financial resources to continue with the development of our infectious disease portfolio.

And also enhances our scientific partnerships.

We look forward to strategically advancing both our oncology and infectious disease pipelines through clinical development and towards future commercialization.

Moving onto our financial position.

Most of you may know that the company just completed 16.5 million dollar financing.

Our strategy of partnering with experts has provided us with the unique opportunity to build a robust pipeline of cancer therapies, and infectious disease vaccines with financial efficiency and the ability to limit the use of the Companys financial resources.

It is extremely important for the company to have the financial resources to optimize the value of our portfolio.

And to advance some of these products to clinical data generation and proof of concept.

This raise is quite important, especially considering the market volatility and uncertainty is created by corporate 19, and other factors by providing the company with the necessary financial runway.

Barring any unforeseen or unusual events.

This allows the company to focus on our product development and provides us with the resources to advance all three currently planned pds or one or one phase two clinical trials through initial data generation.

Michael King Pds Biotechnologies interim CFO will provide additional information on the Companys financial position.

I would now like to hand, the call over to Dr. Loring Ward, our Chief Medical officer to discuss recent clinical updates in our oncology and infectious disease pipelines.

Sure. Thank you Frank.

Thank you Frank and once again welcome everyone to this morning's conference call.

As Frank mentioned in his opening remarks, we've made significant progress over the past few months in built our immuno oncology and infectious disease pipelines. The recent initiation of our stage two clinical study with the National Cancer Institute for our lead candidate Pds, one or one as well as our continued.

We will work included 19 and influenza continue to demonstrate our commitment to building a strong repository of clinical and scientific data on our virtual platform, while progressing the products through clinical development two successful commercialization.

Before I review, our recent clinical advancements I'd like to provide a quick overview of how is the first immune technology platform works.

I try to type line is based on combining our proprietary version huge T cell activating technology with tumor for virus associated proteins to enhance the recognition I'd human immune system.

As you mean effectively deliveries these disease specific proteins called antigens to the immune system for a static uptake and processing, while simultaneously activating the critical type one interferon immunologic pathway.

These two important activities result in the generation of potent disease specific killer T cells as well as neutralizing antibodies.

Activated disease specific T cells are a critical importance in both immuno oncology and infectious disease. As these activated T cells have the ability to identify and killed both cancer cells as well as virus infected cells.

And to provide long term any in memory.

We believe that first immuno overcomes many of the key limitations of current therapeutic and prophylactic approaches in generating these powerful disease attacking chiller tradeshows.

Likewise, firstly means demonstrated ability to activate the preventative or just answered 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 prudent immune responses that include both killer T cells and antibodies present, an important opportunity to develop new vaccines and treatments to improve disease outcomes.

I'll now turn to the multiple recent study initiation for lead oncology candidate Pds or one or one as you may remember Pds a 101 is a combination of various simeon with a proprietary mix of short proteins from human Papilloma virus 16, the most derailment.

Hi, rich type of HPV associated with the development of cancer.

In June we were very pleased to announce that the national Cancer Institute had dosed. The first patient in a stage two clinical study and Pds I want to one in combination with two immune modulating agents the novel by functional checkpoint inhibitor and 70 824 and.

An antibody conjugated cytokine called NHS IL 12.

This study will enroll approximately 30 patients with advanced HPV associated cancer.

And its primary endpoint is to evaluate the objective response rate of this novel Triple combination in head and neck cervical Aon and other HPV related cancers.

The first eight patients will be evaluated for safety and objective response before the trial expands to full enrollment.

We believe this clinical study based on the published preclinical data of the Triple combination represents a critical next step invalidating brixey means ability to induce high levels of tumor specific CD eight killer T cells and that this combination has the potential to significantly improve clinical.

Outcomes for patients with recurrent metastatic HPV associated cancers.

We look forward to providing updates as this trial progresses.

As Frank mentioned earlier, Pds biotech and MD Anderson cancer Center are preparing to initiated trial to evaluate pds or one or one in combination with standard of care chemo radiation chemo Reighty radio therapy for treatment of advanced localized cervical cancer.

The second combination trial to be conducted in approximately 35 patients will investigate the safety and preliminary anti tumor activity of the Pds, a 101 chemo radiation therapy combinations and its correlation with various important biomarkers of the new research.

But.

We believe that PDL, one on ones demonstrated ability to activate the immune system to induce tumor targeting killer T cells provide strong potential to improve treatments to patients with cervical cancer.

Finally, we had been in frequent communication with our clinical sites regarding our versatile zero zero to study Pds a 101 in combination with Keytruda that was paused any early months I've covered 19.

Sites have implemented institution specific measures to ensure a distinct if patient and staff as well as the conduct of clinical research studies, despite the ongoing pandemic.

On the study patients will receive a total of five cycles of combination therapy in the context of standard of care Keytruda therapy administered every three weeks until disease progression.

Although many oncology clinical studies were paused patients' needs for novel cancer treatment options for recurrent or metastatic disease did not.

We anticipate being able to reactivate the study by year end and remain optimistic about the studies contribution to confirming each pds Oh, one on ones ability to enhance standard of care treatments for patients with advanced cancers.

Now I would like to summarize our work in the development of a next generation covered 19 vaccine.

We recently announced preclinical data for Pds OTO, three which pairs are breast immune platform with a recombinant protein derived from Sars co lead to the virus that causes coke at 19.

The stars could be two protein includes sections that induce an antibody response as well sections that are recognized by CD eight and fee for T cells.

Recent research has highlighted the important role that our T cells may play in providing protection against covert 19.

This emerging knowledge highlights the importance of developing vaccines capable of generating high levels of virus specific CD eight and Cdfour T cells. In addition to neutralizing antibodies to potentially achieve more durable protection against curve at night.

Teen infection.

In preclinical studies Pds O'toole three demonstrated rapid induction of highly potent virus specific CD eight killer and CD for helper T cells as well as neutralizing antibodies.

Importantly, these preclinical studies also in depth demonstrated induction of long lasting virus specific memory T cells, which are essential for long term protection.

Specifically Tds OTI will treat demonstrated a 30 to 45 fold increase in coated 19 specific T cells by day 14, when compared to the Sars koby to protein without first immune.

These preclinical studies also confirms that the induction of strong anti Sars koby to neutralizing antibodies within 14 days of vaccination.

20 to 20 fivefold increase over the vaccine without first union.

Importantly, the levels of these neutralizing antibodies a day 14 were comparable to those observed in hospitalized covert 19 patients.

Lastly, these preclinical studies showed a further substantial increase in neutralizing antibody levels up to 30 days.

After vaccination.

These preclinical data demonstrate pds altshuler threes ability to rapidly induce high levels of both protective antibodies and long lasting virus specific T cells against covered 19.

We're hopeful that these results demonstrated in the preclinical studies will translate well to humans.

Our goal is to develop a next generation vaccine that provides the breadth and level of immune responses necessary for a safe and effective vaccine with durable protection against Cobot 19.

We are optimistic that Pds auteur three has the potential to clearly differentiate itself from other coated 19 vaccines in development.

Hi, providing a high level of virus specific killer immune responses and potential long term protection against the virus.

We remain committed to investigating the potential by quickly advancing Pds o'toole three into phase one trials to confirm its ability to rapidly induce both killer T cell and neutralizing antibody responses.

We recently received feedback from the FDA on our preclinical and clinical development plan for Pds or two or three and are currently working to incorporate their recommendations into our clinical trial design and additional preclinical studies.

The ability averse Simeon to induce a broad range of anti viral immune responses is also being applied to the development of a universal flu vaccine Pds oetwo too.

Upcoming Pds, Oh, two or two preclinical studies are being funded by a grant from the NIH I'd, we hope to complete these developments studies in 2021, and then rapidly progressive program into human clinical trials.

I would now like to hand, the call over to our interim CFO Michael King.

Michael.

Thank you Lauren.

I would like to review our financial results for the three months ended June Thirtyth 2020.

For the second quarter 2020, net loss was approximately 2.9 million or 19 cents per basic and diluted share compared to a net loss of approximately 3.9 million for 75 cents per basic and diluted share for the second quarter of 29 team.

Research and development expenses totaled approximately one point fourmillion for the second quarter 2020, compared to approximately 1.9 million. The same period in 2019, a decrease of 26%.

For the second quarter 2020.

Phoenix expenses were approximately 1.5 million.

Compared with approximately 2.4 million for the second quarter of 29 pain.

The decrease of 38%.

Total operating expenses for the second quarter or approximately 2.9 million compared to total operating expenses of approximately 4.3 million for the same period in 2019.

The decrease of 33%.

As of June Thirtyth, the company's cash balance was approximately 16.9 million.

In addition.

On Tuesday of this week.

We announced pricing of the previously announced underwritten public offering.

Consisting of 6 million shares.

Common stock at a public offering price of two point.

To 75 per share.

The gross proceeds from this offering are expected to be 16.5 million.

Before deducting underwriting discounts and commissions and other operating expenses.

In addition, we granted the underwriter Oppenheimer Enco.

A 30 day option to purchase up to 900000 additional shares of common stock.

The public offering price.

Let's see underwriting discounts and commissions.

This offering is closing today subject to customary closing conditions.

Pds biotech intends to use the proceeds from this offering to fund working capital and general corporate expenses.

As Greg mentioned earlier.

Expected this will provide us with the necessary financial resources.

To answer all three currently planned Pds Ono, one phase two 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.

Thank you Michael.

Before we end the call I would like to thank our dedicated team and clinical partners, who all their work over the past quarter.

The initiation of phase two trial in partnership with the National Cancer Institute and the upcoming Phase two clinical trial at MD Anderson Cancer Center.

Continue to validate our novel burst mean platform in the field of immuno oncology.

In addition, the recent grants from an I.D., both the development of a universal influenza vaccine.

And the financial support our offer Pharmacore has received for the preclinical development of the Cobot 19 vaccine.

Will help us to advance those programs rapidly towards human clinical trials.

Over the coming months, we look forward to re initiating our phase two combination trial, a PDF or want to one anchor through their aggressing first line treatment are recurrent or metastatic HPV positive head and neck cancer.

We also look forward to advancing our cobot 19 vaccine programs into clinical trial.

The recent fund raise provides us with the financial resources to progress the development of our Pds a one off one programs through initial phase two 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.

Thank you very much for joining us today.

This concludes todays conference you may disconnect your lines at this time. Thank you for your participation.

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