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PDS Biotech Announces Clinical Strategy Update and Reports Full Year 2023 Financial Results

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PDS Biotechnology announces successful clinical trials with a 3-year survival rate of 75% in advanced head and neck cancer, leading to a focus on a triple combination treatment. The company reports strong safety profiles of its drugs and plans to start a pivotal randomized trial. Financially, PDS Biotech saw a net loss increase due to higher operating costs and interest expenses, despite a decrease in research and development expenses.
Positive
  • Successful Phase 2 trials show a 3-year survival rate of 75% with the triple combination treatment for head and neck cancer.
  • Company to prioritize a triple combination treatment involving PDS01ADC, Versamune® HPV, and KEYTRUDA® for advanced head and neck cancer.
  • Positive safety profile of PDS01ADC and promising results in clinical trials lead to a strategic shift in clinical development strategy.
  • FDA provides clear guidance on trial design and regulatory pathway for pivotal randomized trial of triple combination treatment.
  • Key opinion leaders in head and neck cancer support the use of the triple combination treatment for HPV+ HNSCC due to significant unmet medical needs.
  • Net loss for the year ended December 31, 2023, was approximately $42.9 million, primarily due to increased operating loss and interest expenses.
  • Research and development expenses decreased in 2023, while general and administrative expenses increased compared to the previous year.
  • Total operating expenses for 2023 increased by approximately 3.3% compared to 2022, with a cash balance of $56.6 million as of December 31, 2023.
Negative
  • None.

The recent clinical trial results indicating a 75% 3-year survival rate and a 75% overall response rate in advanced head and neck cancer patients treated with the triple combination of PDS01ADC, PDS0101 (Versamune® HPV) and KEYTRUDA® represent a significant development in the field of oncology. Advanced head and neck cancers, particularly those that are HPV-positive, have historically been challenging to treat, with limited options for patients who have become resistant to first-line treatments like immune checkpoint inhibitors (ICIs).

The observed efficacy of this triple combination could potentially fill a substantial treatment gap and offer hope for improved patient outcomes. However, while the data is promising, it is important to note that the results must be viewed in the context of the broader oncology landscape. The next steps would involve a pivotal randomized trial to confirm these findings in a larger patient population and to compare them directly against the current standard of care. The strong safety profile of PDS01ADC, as demonstrated in over 300 cancer patients, is also a critical factor, as treatment tolerability is a key concern in cancer therapies.

From a research perspective, it would be essential to closely monitor the upcoming trial's design, as guided by the FDA, to ensure that it will adequately capture the efficacy and safety data needed for potential approval. This trial's outcome will have significant implications for the company's valuation and future revenue streams.

The strategic shift by PDS Biotechnology Corporation to prioritize the triple combination treatment for advanced head and neck cancer is a calculated move that aligns with the current market demand for innovative and effective oncology treatments. The company's engagement with the FDA and key opinion leaders in the field underscores the importance of collaborative efforts in advancing clinical development.

From a market perspective, the high survival rates and response rates reported are likely to generate significant interest among healthcare providers and patients. This interest could translate into a competitive advantage for PDS Biotech if the triple combination is approved. Moreover, the potential to treat multiple HPV-positive cancers could expand the market opportunity for the company significantly.

Investors would be keen on the progress of the pivotal trial, as its success could lead to a surge in the company's stock value. However, they should also be aware of the risks associated with clinical trials, including the possibility of not meeting endpoints or encountering regulatory hurdles. The financial results indicate an increased net loss, but this is not uncommon for biotech companies in the clinical development stage. The company's cash balance and recent capital raise suggest it has sufficient runway to fund its operations and clinical trials in the near term.

Reviewing PDS Biotechnology Corporation's financial results alongside their clinical strategy update provides a comprehensive picture of the company's current position and future prospects. The increase in net loss year-over-year is attributed to an increased operating loss and net interest expense. While such increases are not unusual for a late-stage biotech company investing heavily in research and development, it is important for potential investors to consider the company's burn rate and the timeline for potential revenue generation from the triple combination therapy.

Given the compelling clinical data presented, the company's decision to focus on the triple combination therapy could be seen as a strategic investment in its most promising asset. The successful completion of the upcoming pivotal trial could potentially lead to FDA approval and commercialization, which would significantly alter the company's financial trajectory. However, until such milestones are reached, the company will likely continue to incur substantial R&D expenses without immediate revenue to offset them.

The raised capital of approximately $10.5 million in net proceeds from 'at-the-market' sales agreements suggests that PDS Biotech has been proactive in securing the funds necessary to support its clinical development strategy. The cash balance of $56.6 million as of December 31, 2023, will be a key figure for investors to monitor, as it indicates the company's financial health and its ability to sustain operations through critical upcoming clinical milestones.

Unique mechanism of action of the combination of PDS01ADC and Versamune® results in 3-year survival of 75% and 75% overall response rate in advanced head and neck cancer trial

As a result, Company to focus late-stage clinical strategy on triple combination of PDS01ADC, PDS0101 (Versamune® HPV) and KEYTRUDA® in advanced head and neck cancer

Strong safety profile of IL-12 fused antibody drug conjugate (PDS01ADC) demonstrated to date with data generated in >300 cancer patients; Versamune® HPV tested in >110 HNSCC patients

Successful recent meeting with FDA provided clear guidance on trial design and regulatory pathway for pivotal randomized trial of triple combination in recurrent metastatic HPV-positive HNSCC

Company to host conference call and webcast today at 8:00 AM ET

PRINCETON, N.J., March 27, 2024 (GLOBE NEWSWIRE) -- PDS Biotechnology Corporation (Nasdaq: PDSB) (PDS Biotech or the Company), a late-stage immunotherapy company focused on transforming how the immune system targets and kills cancers and the development of infectious disease vaccines, today announced an update to its clinical development strategy and reported its financial results for the year ended December 31, 2023.

“We have obtained compelling data from several Phase 2 trials in the fourth quarter of 2023, including long-term survival data from the National Cancer Institute (NCI)-led triple combination trial of PDS01ADC in combination with Versamune® HPV (PDS0101) and an investigational immune checkpoint inhibitor (ICI), as well as our VERSATILE-002 study,” said Frank Bedu-Addo, PhD, President and Chief Executive Officer of PDS Biotech. “We now have a better understanding of how our drug platform technology works in advanced cancer, and we have therefore made the strategic, data-driven decision to add our novel, investigational IL-12 fused antibody drug conjugate, PDS01ADC, to the promising combination of Versamune® HPV and KEYTRUDA® to advance the triple combination as our top clinical development priority.”

“By initially addressing the rapidly growing unmet medical need in recurrent metastatic HPV+ head and neck squamous cell cancer (HNSCC), we strongly believe this approach may rapidly establish our proprietary combination of PDS01ADC and Versamune® HPV as a transformative oncology treatment. The data suggest that the triple combination may result in a significant improvement in overall survival rates for patients who currently lack an effective treatment option. It may also significantly increase the rates of durable tumor shrinkage or overall responses,” said Dr. Bedu-Addo. “We are grateful to the patients and physicians who participated in the clinical trials which have helped inform our understanding of how the drug therapies may be used most effectively to safely address advanced cancer, and our decision to prioritize the triple combination.”

With the recent long-term survival Phase 2 data from the NCI-led triple combination trial, together with favorable safety and extended survival results seen in both ICI naïve and resistant patients in our VERSATILE-002 trial, PDS Biotech has decided to prioritize the triple combination in place of the VERSATILE-003 trial. This decision enables PDS Biotech to focus its resources on the drug regimen it believes has the highest potential to benefit patients with HNSCC and to drive shareholder value.

“We have had several discussions with key opinion leaders in HNSCC regarding the use of the triple combination in HNSCC. A clear unmet need is seen in HPV+ HNSCC with few agents being studied in this population due to the difficulty in treating advanced HNSCC,” said Kirk V. Shepard, M.D., Chief Medical Officer of PDS Biotech. “These discussions with expert HNSCC oncologists have guided our decision to prioritize the triple combination in our efforts to address the growing incidence of advanced HPV+ HNSCC.”

“Despite good outcomes in many patients with HPV-related HNSCC, approximately 20% of patients will develop recurrent, incurable disease, often in young individuals in the prime of their lives. HPV-related HNSCC that progresses after standard first-line chemotherapy is a devastating, hard-to-treat cancer with no HPV-related treatment currently approved. The NCI clinical trial data show significant promise in the use of PDS01ADC in combination with Versamune® HPV,” said Katharine A. Price, M.D., Associate Professor of Oncology, Head and Neck Disease Group, Mayo Clinic Comprehensive Cancer Center and Principal Investigator of PDS Biotech’s upcoming triple combination trial. “A controlled randomized clinical trial that builds upon the current data is warranted, and I am intrigued by the potential of this unique combination to treat HNSCC.”

Clinical Strategy Update

Triple Combination Clinical Trial (PDS01ADC, Versamune® HPV and KEYTRUDA®)

  • Company in discussions with the U.S. Food and Drug Administration (FDA) on the design of potentially pivotal clinical trial to treat HPV+ HNSCC, with the trial expected to start in 2024.
  • Previously announced data from Phase 2 NCI-led triple combination clinical trial for the treatment of recurrent/metastatic ICI naïve and ICI resistant HPV16-positive cancers including head and neck, anal, cervical, vaginal and vulvar cancers support rationale:
    • ICI naïve group: 75% of patients remain alive at 36 months. The median overall survival (OS) was not reached. Published results show a 36-month survival rate of approximately 20% with ICIs. An overall response rate (ORR) of 75% and complete response of 38% were seen in patients treated with the triple combination. Published ORR of <40% seen with immunotherapeutic agents.
    • ICI resistant group: 12-month OS rate of 72%, and 63% ORR in patients with optimal dose of PDS01ADC. Median OS approximately 20 months; published 12-month OS rate in HPV-positive ICI-resistant cancer is ~30%; published median OS in HPV-positive ICI-resistant cancer is 3.4 months.
    • Responses were seen in all HPV-positive tumor types.

Leadership Appointments

  • In January 2024, announced the appointment of Dr. Shepard as Chief Medical Officer.
  • In November 2023, announced the appointment of Lars Boesgaard as Chief Financial Officer.

Full Year 2023 Financial Results

Net loss for the year ended December 31, 2023, was approximately $42.9 million, or $1.39 per basic and diluted share, compared to a net loss of $40.9 million, or $1.43 per basic share and diluted share, for the year ended December 31, 2022. The higher net loss was primarily the result of increased operating loss and increased net interest expense.

Research and development expenses for the year ended December 31, 2023, decreased to $27.8 million, compared to $29.4 million for the year ended December 31, 2022. The decrease of $1.7 million was primarily attributable to the $10 million purchase of the rights to PDS01ADC in 2022, partially offset by an increase in clinical costs of $6.1 million and an increase in personnel costs of $2.1 million.

General and administrative expenses for the year ended December 31, 2023, increased to $15.3 million compared to $12.2 million for the year ended December 31, 2022. The $3.1 million increase was primarily attributable to an increase in personnel costs of $1.5 million and an increase in professional fees of $1.6 million.

Total operating expenses for the year ended December 31, 2023, were $43.0 million, an increase of approximately 3.3% compared to $41.7 million total operating expenses for the year ended December 31, 2022.

Net interest expense increased to $1.3 million for the year ended December 31, 2023, compared to $0.4 million for the year ended December 31, 2022. The change was due to higher interest expense related to the Company’s notes payable, partially offset by higher interest income on bank deposits.

During the fourth quarter of 2023, the Company raised approximately $10.5 million in net proceeds from its “at-the-market” sales agreement.

The Company’s cash balance as of December 31, 2023, was $56.6 million.

Conference Call and Webcast
The conference call is scheduled to begin at 8:00 AM ET today, March 27, 2024. Participants should dial 877-704-4453 (United States) or 201-389-0920 (International) and reference conference ID 13745320. To access the webcast, please use the following link. The event will be archived on the Investor Relations section of PDS Biotech’s website for six months.

About PDS Biotechnology
PDS Biotechnology is a late-stage immunotherapy company focused on transforming how the immune system targets and kills cancers and the development of infectious disease vaccines. The Company plans to initiate a pivotal clinical trial in 2024 to advance its lead program in advanced head and neck squamous cell cancers (HNSCC). PDS Biotech’s lead program is a proprietary dual-acting combination of antibody drug conjugate (ADC) PDS01ADC and T-cell activator Versamune® HPV in regimen with a standard-of-care immune checkpoint inhibitor. Proof-of-concept long-term data have shown positive survival results and tumor shrinkage with this combination and indicate favorable tolerability.

With a novel investigational “inside-out” mechanism, the dual immunotherapy has shown compelling results with potential to successfully disrupt a tumor’s inside defenses, while also generating potent, targeted killer T-cells to attack the tumor from the outside. Robust data from more than 350 patients, as well as ongoing clinical trials across multiple tumor types and standard treatment regimens, have validated the platforms and point to potential broad utility.

Our Infectimune® based vaccines have demonstrated the potential to induce not only robust and durable neutralizing antibody responses, but also powerful T-cell responses, including long-lasting memory T-cell responses in pre-clinical studies to date. For more information, please visit www.pdsbiotech.com.

Forward Looking Statements
This communication contains forward-looking statements (including within the meaning of Section 21E of the United States Securities Exchange Act of 1934, as amended, and Section 27A of the United States Securities Act of 1933, as amended) concerning PDS Biotechnology Corporation (the “Company”) and other matters. These statements may discuss goals, intentions and expectations as to future plans, trends, events, results of operations or financial condition, or otherwise, based on current beliefs of the Company’s management, as well as assumptions made by, and information currently available to, management. Forward-looking statements generally include statements that are predictive in nature and depend upon or refer to future events or conditions, and include words such as “may,” “will,” “should,” “would,” “expect,” “anticipate,” “plan,” “likely,” “believe,” “estimate,” “project,” “intend,” “forecast,” “guidance”, “outlook” and other similar expressions among others. Forward-looking statements are based on current beliefs and assumptions that are subject to risks and uncertainties and are not guarantees of future performance. Actual results could differ materially from those contained in any forward-looking statement as a result of various factors, including, without limitation: the Company’s ability to protect its intellectual property rights; the Company’s anticipated capital requirements, including the Company’s anticipated cash runway and the Company’s current expectations regarding its plans for future equity financings; the Company’s dependence on additional financing to fund its operations and complete the development and commercialization of its product candidates, and the risks that raising such additional capital may restrict the Company’s operations or require the Company to relinquish rights to the Company’s technologies or product candidates; the Company’s limited operating history in the Company’s current line of business, which makes it difficult to evaluate the Company’s prospects, the Company’s business plan or the likelihood of the Company’s successful implementation of such business plan; the timing for the Company or its partners to initiate the planned clinical trials for PDS01ADC, PDS0101, PDS0203 and other Versamune® and Infectimune® based product candidates; the future success of such trials; the successful implementation of the Company’s research and development programs and collaborations, including any collaboration studies concerning PDS01ADC, PDS0101, PDS0203 and other Versamune® and Infectimune® based product candidates and the Company’s interpretation of the results and findings of such programs and collaborations and whether such results are sufficient to support the future success of the Company’s product candidates; the success, timing and cost of the Company’s ongoing clinical trials and anticipated clinical trials for the Company’s current product candidates, including statements regarding the timing of initiation, pace of enrollment and completion of the trials (including the Company’s ability to fully fund its disclosed clinical trials, which assumes no material changes to the Company’s currently projected expenses), futility analyses, presentations at conferences and data reported in an abstract, and receipt of interim or preliminary results (including, without limitation, any preclinical results or data), which are not necessarily indicative of the final results of the Company’s ongoing clinical trials; any Company statements about its understanding of product candidates mechanisms of action and interpretation of preclinical and early clinical results from its clinical development programs and any collaboration studies; the Company’s ability to continue as a going concern; and other factors, including legislative, regulatory, political and economic developments not within the Company’s control. The foregoing review of important factors that could cause actual events to differ from expectations should not be construed as exhaustive and should be read in conjunction with statements that are included herein and elsewhere, including the other risks, uncertainties, and other factors described under “Risk Factors,” “Management’s Discussion and Analysis of Financial Condition and Results of Operations” and elsewhere in the documents we file with the U.S. Securities and Exchange Commission. The forward-looking statements are made only as of the date of this press release and, except as required by applicable law, the Company undertakes no obligation to revise or update any forward-looking statement, or to make any other forward-looking statements, whether as a result of new information, future events or otherwise.  

Versamune® and Infectimune® are registered trademarks of PDS Biotechnology Corporation.

KEYTRUDA® is a registered trademark of Merck Sharp and Dohme LLC, a subsidiary of Merck & Co., Inc., Rahway, N.J., USA.

Investor Contact:
Mike Moyer
LifeSci Advisors
Phone +1 (617) 308-4306
Email: mmoyer@lifesciadvisors.com

Media Contact:
Gina Mangiaracina
6 Degrees
Phone +1 (917) 797-7904
Email: gmangiaracina@6degreespr.com

 
PDS BIOTECHNOLOGY CORPORATION AND SUBSIDIARY
Unaudited Consolidated Statements of Operations and Comprehensive Loss
    
 Year Ending December 31,
 2023 2022
Operating expenses:   
Research and development expenses$27,762,784  $29,431,027 
General and administrative expenses$15,282,450  $12,241,394 
Total operating expenses$43,045,234  $41,672,421 
    
Loss from operations$(43,045,234) $(41,672,421)
    
Interest income (expense), net   
Interest income$2,902,939  $935,180 
Interest expense$(4,205,922) $(1,316,519)
Interest income (expense), net$(1,302,983) $(381,339)
    
Loss before income taxes$(44,348,217) $(42,053,760)
Benefit from income taxes$1,406,021  $1,198,905 
Net loss and comprehensive loss$(42,942,196) $(40,854,855)
    
Per share information:   
Net loss per share, basic and diluted$(1.39) $(1.43)
Weighted average common shares outstanding basic and diluted 30,952,060   28,599,221 
    


PDS BIOTECHNOLOGY CORPORATION AND SUBSIDIARY
unaudited selected Balance Sheet Data
 
 December 31,
 December 31,
 2023
 2022
Cash and cash equivalents$56,560,517  $73,820,160 
Working Capital $45,425,100  $66,659,354 
Total assets$59,390,082  $77,007,923 
Long term Debt$19,506,183  $23,020,844 
Accumulated Deficit$(144,500,613) $(101,558,417)
Total stockholders’ equity$26,130,949  $44,002,030 
      

FAQ

What is the 3-year survival rate in the advanced head and neck cancer trial involving PDS01ADC and Versamune®?

The 3-year survival rate in the trial was 75%.

What is the focus of the company's late-stage clinical strategy?

The company plans to focus on a triple combination of PDS01ADC, Versamune® HPV, and KEYTRUDA® for advanced head and neck cancer.

What is the safety profile of PDS01ADC?

PDS01ADC has demonstrated a strong safety profile in over 300 cancer patients.

What guidance did the FDA provide to the company?

The FDA provided clear guidance on trial design and regulatory pathway for a pivotal randomized trial of the triple combination.

What was the net loss for the year ended December 31, 2023?

The net loss for the year was approximately $42.9 million.

How did research and development expenses change in 2023 compared to 2022?

Research and development expenses decreased in 2023.

What was the cash balance of the company as of December 31, 2023?

The cash balance was $56.6 million as of December 31, 2023.

PDS Biotechnology Corporation

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About PDSB

pds biotechnology is a clinical stage biopharmaceutical company developing the next-generation of simpler, safer and more effective immunotherapies for cancer and infectious diseases. pds biotechnology’s proprietary versamune® platform vector is based on synthetic and biodegradable lipids which possess a very specific structure and positive charge. the lipids form nanoparticles which activate and are taken up very efficiently by the immune system. the therapeutic product consists of versamune® formulated with a harmless form of the protein or disease-causing agent associated with the particular disease (the antigen) which our immune systems can recognize and respond to. this antigen could be a unique protein expressed only in the cancer cells and not in healthy cells, or it could be a specific viral protein(s) from an infectious virus for example. pds is in the process of completing its first phase 1 human clinical trial in 2015 for pds0101, and has initiated design and preparati