PDS Biotechnology at Life Sciences Virtual Investor Conference: Strategic Advances in Cancer Treatment

On Thursday, 13 March 2025, PDS Biotechnology Corp (NASDAQ: PDSB) presented at the Life Sciences Virtual Investor Conference, detailing its strategic focus on advancing its lead clinical candidate, Versimmune HPV, for HPV16-positive head and neck cancer. The company highlighted promising clinical results and outlined financial challenges, emphasizing a need for further funding to complete ongoing trials.

Key Takeaways

• PDS Biotechnology is targeting the unmet need in HPV16-positive head and neck cancer, with its lead candidate, Versimmune HPV.
• The Versatile-2 study showed a median overall survival of 30 months, significantly surpassing current therapies.
• The company has initiated a Phase 3 trial, Versatile-3, comparing Versimmune HPV plus Keytruda to Keytruda alone.
• PDS Biotechnology secured $11 million in recent financing but requires additional funding to complete trials.
• Partnerships with the National Cancer Institute and academic institutions are being pursued to support pipeline development.

Financial Results

• Recent Financing: Raised $11 million, sufficient to commence the Phase 3 trial.
• Future Funding Needs: Plans to raise additional capital incrementally as the trial progresses.
• Partnership Strategy: Collaborating with the National Cancer Institute and academic institutions to advance their pipeline without diverting resources from the Versatile-3 trial.

Operational Updates

• Versimmune HPV Trials:

- Versatile-2: Completed Phase 2 study showing a median overall survival of 30 months.

- Versatile-3: Ongoing Phase 3 trial with a primary endpoint of overall survival.

- Neo Adjuvant Study: Preliminary results are expected soon for the study involving Versimmune HPV and Keytruda in early-stage oral cancer.

- National Cancer Institute Trials: Ongoing trials with PDS01ADC in colorectal and gallbladder cancer, and a controlled study of PDS101 plus Astellas Xtendi versus Xtendi alone in prostate cancer.

- Recruitment: Engaging most Phase 2 sites and adding new ones.

Future Outlook

• Milestones:

- Late Q2 or Early Q3 This Year: Final results from the Versatile-2 study.

- First Half of 2026: Readouts from ongoing studies at the National Cancer Institute with PDS01ADC.

• Strategic Focus: Prioritizing the Versatile-3 registrational trial to secure market leadership in HPV16-positive cancer treatment.

Q&A Highlights

• Merck Partnership: While engaged with Merck, a drug supply deal is not anticipated due to Keytruda’s upcoming patent expiration.
• Interim Data Readout: Dependent on recruitment rates; updates will be provided as the trial progresses.
• Pipeline Development: Focused on gaining approval for the dual combination of Versimmune HPV and Keytruda, with support from academic collaborations.

Readers are encouraged to refer to the full transcript for a detailed understanding of PDS Biotechnology’s strategic initiatives and clinical advancements.

Full transcript - Life Sciences Virtual Investor Conference:

John, Host, Life Science Investor Forum / Zach Smallcap Research: Hello, and welcome to the Virtual Investor Conference Series. On behalf of the Life Science Investor Forum, as well as our co host, Zach Smallcap Research, we’re very pleased you joined us for our next presentation from PDS Biotechnology. Please note you can submit questions for the presenter in the box to the left of the slides. You can also view a company’s availability for one on one meetings through the Book Meeting tab found on the top toolbar. At this point, I’m very pleased to welcome our next presenter, Frank Badu Adeau.

He’s the President and Chief Executive Officer of PDS Biotechnology Corporation, which trades on NASDAQ under the symbol PDSB. Welcome, Frank.

Frank Badu Adeau, President and CEO, PDS Biotechnology Corporation: John, thank you very much for the introduction and also for the opportunity to present here today at the Zacks SCR Life Sciences Investor Forum. Next slide, please. To everyone, please be aware of the risk factors associated with PDS Biotechnology and as filed with the SEC. Next slide, please. PDS biotechnology is a late clinical stage immuno oncology company developing targeted immunotherapies for cancer.

Our lead clinical candidate Versimmune HPV is a proprietary HPV sixteen targeted immunotherapy. The lead indication is recurrent and or metastatic HPV sixteen positive head and neck cancer. This constitutes a 2 to $3,000,000,000 opportunity in The United States and a 4 to $5,000,000,000 opportunity in The United States and Europe combined. Now, HPV HPV16 positive head and neck cancer is on a significant rise and today sixty to seventy percent of oral cancers are reported to be HPV sixteen positive. There are currently no FDA approved drugs for the growing population of HPV sixteen positive head and neck cancer and therefore the treatments are the same across board whether or not the patients are HPV sixteen positive or negative.

Now our Head and Neck Cancer Program has been awarded fast track designation by the FDA based upon the phase two clinical results, which we’ll talk about today. And the recently initiated phase three trial is the first ever registrational trial to be performed in HPV sixteen positive recurrent and or metastatic head and neck cancer. FDA fast track designation coupled with the ongoing registrational trial presents strong potential to be first to market resulting in an opportunity for market leadership. Next slide. Now here we look at the dramatic rise projected in head and neck cancer incidence over the next twenty or so years.

The increase in incidences of head and neck cancer has been described as a silent epidemic. And here I show a plot from a 2022 article published in the highly respected Lancet journal. Now this article projects a significant increase in head and neck cancer cases as I mentioned over the next twenty years or so. But what is quite significant is the fact that the projected increase is almost exclusively driven by HPV sixteen. Now these incidences take into consideration the current preventive HPV vaccination rates.

And as I just mentioned, the market potential for Versimmune HPV specifically in recurrent and or metastatic HPV sixteen positive head and neck cancer is about $2 to $3,000,000,000 in The United States alone. Next slide please. So now let’s move on to the limitations of current therapy. Head and neck cancer is one of the most debilitating cancers with suicide rates of over three times that of The US general population. Now this slide highlights the problem that we seeking to address, specifically the safety and the survival limitations of the current therapies for current and or metastatic head and neck cancer.

Now as shown here with any of the three most frequently administered FDA approved therapies, the median overall survival for these patients is only about twelve months. Now this means that if a patient is diagnosed with recurrent and or metastatic head and neck cancer today, on the current therapies they have a fiftyfifty chance of living twelve months. So that’s something to remember as we go to go along in the presentation. Twelve months median overall survival today with the current therapies. Now it’s also notable as you can see on the slide on the third column that even though the EGFR inhibitor plus chemotherapy has a significantly better objective response rate than Keytruda, this did not translate to improved survival.

And these patients actually had worse survival than the patients on Keytruda. And so in this population, the objective response rate does not appear to translate to survival. It’s also important to note here in the middle column that the addition of chemotherapy to Keytruda provided about one month of additional survival but more than fourfold increase in severe adverse events. So a significant price to pay for an additional month in survival. So this is the state of the art for current therapeutic options in recurrent metastatic head and neck cancer.

Next slide. So now moving on to our study. In our study, we administer a combination of Versimmune HPV and Keytruda. Versimmune HPV activates and trains the immune system to recognize, target, and kill cancer cells that are positive for HPV sixteen. In this trial, the patient receives Keytruda by IV every three weeks until toxicity or death or for up to two years.

The patient also receives a total of five subcutaneous injections of Versumine HPV in the upper arm once every three weeks for the first four cycles. The fifth and final dose is received on the twelfth cycle. Patients had to be at least 18 years of age and they had to meet the approved requirements for Keytruda with PD L1 composite positive score or CPS of greater than or equal to one. This study was performed at 31 sites in The United States and Europe. Next slide please.

Now this slide shows the demographics of the patients in our study. The majority of the patients over ninety percent were white males with median age of 64. This is the typical population for recurrent and or metastatic head and neck cancer. In these patients, Keytruda is shown to perform much better in patients who have a higher PD L1 expression with the highest CPS status of 20 and above. So do note that in our study, as you can see highlighted, forty percent of the patients fall into this category and sixty percent of the patients are actually in the lower responding group.

Also eighty percent of the patients had failed or progressed after prior treatment on other therapies. So it is important to note that the patients on our trial are skewed towards the typically lower responders to Keytruda. Next slide, please. So now moving on to the results of our study, the Versatile two study. Now there are three clinical response characteristics that the next generation of cancer therapies should exhibit.

The first is tumor shrinkage. Most chemotherapeutic and cytotoxic drugs as well as the EGFR antibodies do this quite well. Versimmune HPV plus Keytruda, as we can see, also achieves impressive tumor shrinkage with over twenty percent of patients experiencing complete or near complete tumor shrinkage and almost eighty percent of patients having tumor shrinkage and or disease stabilization, which is extremely encouraging. Now the big limitation facing today’s therapies for metastatic cancer is disease recurrence or continued spread after treatment. A disease recurrence is very common once therapy is stopped.

Keytruda, for example, as I mentioned, has to be given every three weeks for up to two years. However, the hurdle to administering these drugs with such required frequency is toxicity. That brings us to characteristic number two, which is durability of the response. Once tumor shrinkage or stable disease is achieved, how durable is that response or how long can that clinical response be maintained? Your ideal cancer therapy should be able to maintain these responses long term and that’s exactly what we see in our trial when we administer adverse immune HPV to Keytruda.

Next slide, please. And so you can see here on the slide that if we look at the patients in green, the complete responders, partial response to tumor shrinkage in blue or stable disease in yellow, that the majority of these patients, whatever their clinical response is, appear to have durable responses with time. Therefore, they maintain that clinical response status over an extended duration of time. And this occurs even with just the four to five doses of Versimmune HPV. Now this is partly due to the induction of what we call a memory immune response which enables the immune system to continue to combat the disease long term without the need for continuous treatment.

And this brings us to characteristic number three which is patient survival. Next slide, please. And so here, if you recall, I mentioned at the start that with the standard of care, the median overall survival today is twelve months. In the versatile two study, we report as seen on the slide a median overall survival of thirty months. So if you were patient on this trial, you had a fiftyfifty chance of living for thirty months or two and a half years.

Next slide, please. The combination was well tolerated with only nine percent of patients having a grade three or grade three toxicity and only one patient having a grade four toxicity which occurred one year after completion of Versimmune HPV therapy while the patient was still on Keytruda therapy. So Versimmune HPV appears to be unique in that by administering it in combination with standard of care such as Keytruda, it does not appear to compound toxicity. Keytruda, as we saw earlier, is reported to have a seventeen percent grade three and higher serious adverse event rate when administered alone. So the Versatile two clinical trial has demonstrated an encouraging combination of safety and clinical response.

Next slide please. Come and go to the next slide. Thank you. So this slide shows the phase three trial design. This is a controlled study of Versumine HPV plus Keytruda versus Keytruda alone in a two to one randomization.

Meaning that for every two patients who get onto the combination one will receive Keytruda standard of care alone. And this was highly recommended by the key opinion leaders to maximize the number of patients who actually get the combination. The patient size three fifty one patients and the trial has an 85% statistical power to detect a ten month difference in survival between the two arms. The trial’s primary endpoint is designed based upon death events to be for median overall survival as guided by the FDA. And secondary endpoints include objective response rate, disease control rate, duration of response and progression free survival.

So what I’m going to do is on the next few slides, I’ll briefly discuss corroborating biomarker and clinical results from our Phase II ImmunoServe trial and the National Cancer Institute led trial that supports the encouraging results seen with Versimmune HPV. So on this slide, we see a study that was independently run by MD Anderson Cancer Center, the ImmunoServe study. Here, the investigator studied two critical parameters. First, quantification of the tumor accumulating HPV sixteen specific killer T cells. Now the inability to effectively achieve the induction of adequate numbers of tumor accumulating killer T cells has been a major deficiency of immunotherapy.

Here in this study, we see highly effective accumulation which are the green bars of active HPV sixteen specific killer CD8 T cells in the tumors over a twenty four week period. Now secondly, it’s well established that what kills the patients isn’t usually the primary tumor but rather the micro metastatic cancer cells that remain and grow aggressively. Now these tumor cells can be quantified using a technique to measure the DNA of the circulating tumor cells in the blood. What we call the circulating tumor DNA. So here, if you look at the green line here, the study shows that as this T cells accumulate in the tumors, the circulating tumor DNA falls to zero.

Now in the February 2025 issue of Clinical Cancer Research, the MD Anderson investigators report that in the study of Versimmune HPV plus standard of care chemo radiotherapy or CRT in the next slide. Next slide please. So this was a study of verzimin HPV plus chemo radiotherapy versus chemo radiotherapy standard of care alone. What they report in this publication is that in the HPV sixteen positive cancer patients at three to four months, circulating tumor DNA was not detectable in one hundred percent of the tested HPV sixteen positive cancer patients. However, on standard of care CRT alone, ctDNA was detectable in fifty percent of the patients.

Now importantly, ctDNA was also shown in the study to be a predictive biomarker. And so what they reported here see look in the second table below was that in the patients who had no detectable ctDNA their two year recurrence free survival was ninety three percent. However, in patients who had detectable ctDNA, recurrence free survival drops significantly down to thirty percent. So the ability of Versumine HPV to clear this HPV sixteen positive circulating tumor DNA appears to be largely responsible for the strong clinical responses and patient survival that we’re seeing in these phase two clinical trials. Next slide please.

Now a third study was also published in the highly respected JAMA Oncology Journal in February of this year by the National Cancer Institute. Now in the study, they enrolled thirty seven HPV sixteen positive recurrent and or metastatic cancer patients. They also enrolled seventeen patients whose tumors were HPV sixteen negative. Now the difference in clinical responses between the two groups of patients was quite dramatic. So as we see here on the slide, when we look at the objective response rate, the HPV sixteen positive patients had a seventy five percent response rate versus zero percent in the patients whose cancer were not HPV sixteen positive.

Now, the progression free survival in the HPV sixteen positive cancer patients was eleven point three months. In the combined group of HPV sixteen positive and HPV sixteen negative patients, the PFS was only two point nine months. So this study appears to confirm that Versamine HPV may be a highly effective HPV sixteen targeted immunotherapy as it was designed to be. So with these corroborating results, we are highly optimistic about the registrational trial in HPV sixteen positive recurrent and or metastatic head and neck cancer and we look forward to reporting the results in the future. Next slide please.

Meanwhile, as we run the Phase three study, there are a number of milestones and catalysts that we anticipate over the next three to eighteen months. In late Q2 or early Q3 of this year, we anticipate announcing the final results from the versatile two study in recurrent and or metastatic HPV sixteen positive head and neck cancer. The exact same patient population that we are studying in our registrational trial. We also expect preliminary results from the Neo adjuvant study of Versimmune HPV and Keytruda in early stage oral cancer. In the first half of twenty twenty six, we expect readouts from two exciting ongoing studies at the National Cancer Institute with our PDS01ADC investigational immunocytokine in colorectal cancer in gallbladder cancer as well as the second trial in biochemically recurrent prostate cancer.

The latter is a controlled study of PDS one hundred and one plus Astellasys Xtendi versus Xtendi alone. So as I mentioned, the next twelve to eighteen months could be quite exciting for the company. Next slide, please. So to conclude, I will reiterate the fact that our primary focus today is our Versatile three registrational trial in HPV sixteen positive recurrent and or metastatic head and neck cancer. The first registrational trial in this rapidly growing population.

The data to date strongly supports Versimmune HPV as an effective HPV sixteen targeted immunotherapy And with the FDA Fast Track designation, we are in strong position for potential market leadership. Thank you very much for your attention and I will be pleased to answer any questions at this time. Thank you very much.

Lars, Questioner: Thank you very much, Frank. It seems like we have a couple of questions, from the audience, submitted here, to to us. So I’ll just go through a couple of them, Frank. The first question says, your results for Versatile three are very encouraging. Are you talking to Merck about partnering for Versatile three in receiving drug?

Frank Badu Adeau, President and CEO, PDS Biotechnology Corporation: Thank you, Lars, for the questions. So to answer the question you just asked, Merck was part of our joint development committee for the Versedel two phase two trial. So we do remain engaged with Merck. However, as has been widely reported, KEYTRUDA does come off patent in a couple of years. And as many of you may be aware, Merck has not really been anxious to do phase three KEYTRUDA supply deals.

So for now, we do not anticipate a drug supply deal and we are proceeding accordingly.

Lars, Questioner: Thanks, Frank. The next question is, you recently raised $11,000,000 and potentially $22,000,000 What is your cash burn with the Phase three being started? And how are you funding the trial?

Frank Badu Adeau, President and CEO, PDS Biotechnology Corporation: Thanks a lot for the question this question. Well, that is correct. We raised $11,000,000 recently. And this has provided us with enough capital to get the trial started. We are pleased with the financing in a very challenging environment for biotech companies like PDS.

But what we raised is not going to take us through completion of the trial. And we plan to raise the necessary capital in a stepwise manner as we make progress with the versatile three trial.

Lars, Questioner: Thanks, Frank. There’s another question here. Since you’ve started the trial, how long will it take you to get to your interim data readout?

Frank Badu Adeau, President and CEO, PDS Biotechnology Corporation: So the day interim data readout timeline is, as some of you may be aware, dependent on the recruitment rates, which also depend on recruitment by the sites and the total number of sites that we have on the trial. So we have most of the phase two sites participating. They know our therapy quite well. But there are also several new sites coming online. So it will take us a few months to better understand what to expect from the recruitment rates and the timing of events, and we will update the markets as that becomes clearer.

Lars, Questioner: Thanks, Frank. I think we have time for one more question here. The question is, what are you doing with your triple combination? The data is very impressive. And it goes on to ask, you have a reasonably deep pipeline and you just raised 11,000,000 to fund your phase three.

How do you plan to develop your pipeline?

Frank Badu Adeau, President and CEO, PDS Biotechnology Corporation: Okay. So just to make sure I’m clear on it, so what are we doing with the triple combination and how do we develop, how do we plan to develop the timeline?

Lars, Questioner: Yeah. The pipeline.

Frank Badu Adeau, President and CEO, PDS Biotechnology Corporation: The pipeline. Okay. Our current so our current plan with a triple combination is to follow the simplest regulatory strategy, which will also feed into our product life cycle management strategy. So the the goal is to get Versedean HPV plus Contruder, what what we’re running in our Versedal zero zero three program, get that combination approved and then add PDS o one ADC to the approved combination to develop the second generation product that may address both checkpoint inhibitor naive as well as checkpoint inhibitor resistant patients. However, today our focus is on Versatile three and getting that dual combination approved.

And that is what the capital that’s been that’s what our capital is being applied to. Now we have been successful in partnering with the National Cancer Institute and top tier academic institutions who have been willing to independently progress these trials with our first mean HPV as well as PDS one ADC. And that allows us to utilize our funds for our lead program, which again is the Versimmune HPV and recurrent metastatic head and neck cancer as we have discussed today. Now you are correct. It is unlikely that we will be able to develop our full pipeline without any partnerships.

So getting studies through phase two via academic collaborations and ready for registrational trials provides us with significant non dilutive benefit and value. And so that’s really the big picture in terms of working with our partners and non academic institutions get through phase two and prepare some of these programs for phase three where we may be able to bring in some some partnerships in the future to get these to the finish line.

Lars, Questioner: Thanks, Frank. I believe that’s all we have time for today in terms of of questions.

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