Full Press Release Details
PDS Biotech Provides Clinical Programs Update and Reports Third Quarter 2024 Financial Results
Conference call and webcast today at 8:30 a.m. Eastern Time
PRINCETON, N.J., November 14, 2024 -- 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 provided a business update and reported financial results for the third quarter of 2024.
"Since our last update in August, we have been actively engaged with investors and clinicians to discuss our strategy and funding requirements for our
VERSATILE-003 Phase 3 trial of Versamune HPV + pembrolizumab compared to pembrolizumab as a potential treatment for first-line recurrent/metastatic HPV16-positive head and neck squamous cell cancer (HNSCC)," said Frank Bedu-Addo, PhD,
President and Chief Executive Officer of PDS Biotech. Dr. Bedu-Addo further noted that "based on investor feedback, discussions with key opinion leaders involved with the study and other experts, we have made minor modifications to the
VERSATILE-003 trial design to reduce the overall cost and time required to achieve an interim data readout and trial completion."
With submission of the updated Investigational New Drug (IND) application to the U.S. Food and Drug Administration (FDA) this week, the Company expects
the FDA clearance decision by mid-December, allowing the Company to initiate site activation in the first quarter of 2025.
"Elsewhere in our pipeline, we were pleased with the data from the IMMUNOCERV Phase 2 clinical trial evaluating Versamune HPV with
chemoradiation to treat locally advanced cervical cancer presented at the American Society for Radiation Oncology (ASTRO) annual meeting. The presented data demonstrated promising clinical activity and a compelling safety profile. Based on
continued research in various HPV-positive cancers conducted by PDS Biotech and independent researchers who recognize its potential, Versamune HPV appears to work in combination with a variety of therapeutic agents to generate
clinical responses and promote improved survival in patients with favorable toxicity. We are exploring the next steps in the development of Versamune HPV for cervical cancer," concluded Dr. Bedu-Addo.
Third Quarter 2024 Financial Results
Reported net loss was approximately $10.7 million, or $0.29 per basic share and diluted share, for the three months ended September 30, 2024, compared to a
net loss of $10.8 million, or $0.35 per basic share and diluted share, for the three months ended September 30, 2023. The decrease was primarily due to lower operating expenses.
Research and development expenses increased to approximately $6.8 million for the three months ended September 30, 2024, from $6.4 million for the three
months ended September 30, 2023. The increase of $0.4 million was primarily attributable to higher manufacturing expenses, partially offset by lower clinical costs and personnel expenses.
General and administrative expenses decreased to approximately $3.4 million for the three months ended September 30, 2024, from approximately $4.1 million
for the three months ended September 30, 2023. The decrease of $0.7 million was primarily attributable to lower personnel costs and professional fees.
Total operating expenses decreased to approximately $10.2 million for the three months ended September 30, 2024, from $10.5 million for the three months
ended September 30, 2023.
Net interest expenses increased to approximately $0.5 million for the three months ended September 30, 2024, from $0.3 million for the three months ended
Cash and cash equivalents as of September 30, 2024 totaled approximately $49.8 million.
Date: November 14, 2024
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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 to advance its lead program in advanced HPV16-positive head and neck
squamous cell cancers. PDS Biotech's lead investigational targeted immunotherapy Versamune
HPV is being developed in combination with a standard-of-care immune checkpoint inhibitor, and also in a triple combination including PDS01ADC, an IL-12 fused antibody drug conjugate (ADC), and a standard-of-care immune checkpoint inhibitor.
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 Versamune HPV, PDS01ADC 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 Versamune HPV, PDS01ADC
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.
Xtandi is a registered trademark of Astellas Pharma Inc.
Phone +1 (617) 308-4306
Email: mmoyer@lifesciadvisors.com
Phone +1 (646) 528-4034
Email: jmccargo@6degreespr.com
PDS BIOTECHNOLOGY CORPORATION AND SUBSIDIARY
Condensed Consolidated Statements of Operations and Comprehensive Loss
| Three Months Ended Sep 30, | Nine Months Ended Sep 30, | |||||||||||||||
| 2024 | 2023 | 2024 | 2023 | |||||||||||||
| Operating expenses: | ||||||||||||||||
| Research and development expenses | $ | 6,803,900 | $ | 6,448,528 | $ | 18,035,762 | $ | 20,297,066 | ||||||||
| General and administrative expenses | $ | 3,374,794 | $ | 4,071,158 | $ | 10,924,863 | $ | 12,341,207 | ||||||||
| Total operating expenses | $ | 10,178,694 | $ | 10,519,686 | $ | 28,960,625 | $ | 32,638,273 | ||||||||
| Loss from operations | $ | (10,178,694 | ) | $ | (10,519,686 | ) | $ | (28,960,625 | ) | $ | (32,638,273 | ) | ||||
| Interest income (expense), net | ||||||||||||||||
| Interest income | $ | 666,770 | $ | 739,404 | $ | 2,010,874 | $ | 2,219,399 | ||||||||
| Interest expense | $ | (1,214,734 | ) | $ | (1,068,887 | ) | $ | (3,577,450 | ) | $ | (3,031,129 | ) | ||||
| Interest income (expense), net | $ | (547,964 | ) | $ | (329,483 | ) | $ | (1,566,576 | ) | $ | (811,730 | ) | ||||
| Loss before income taxes | $ | (10,726,658 | ) | $ | (10,849,169 | ) | $ | (30,527,201 | ) | $ | (33,450,003 | ) | ||||
| Benefit for income taxes | $ | 869,169 | $ | 1,406,021 | ||||||||||||
| Net loss and comprehensive loss | $ | (10,726,658 | ) | $ | (10,849,169 | ) | $ | (29,658,032 | ) | $ | (32,043,982 | ) | ||||
| Per share information: | ||||||||||||||||
| Net loss per share, basic and diluted | $ | (0.29 | ) | $ | (0.35 | ) | $ | (0.82 | ) | $ | (1.04 | ) | ||||
| Weighted average common shares outstanding basic and diluted | 36,806,592 | 30,910,520 | 36,107,900 | 30,715,458 |
PDS BIOTECHNOLOGY CORPORATION AND SUBSIDIARY
Unaudited Selected Balance Sheet Data
| Sep 30, | December 31, | |||||||
| 2024 | 2023 | |||||||
| Cash and cash equivalents | $ | 49,751,252 | $ | 56,560,517 | ||||
| Working capital | $ | 33,791,108 | $ | 45,425,098 | ||||
| Total assets | $ | 52,450,653 | $ | 59,390,080 | ||||
| Long term debt | $ | 12,031,986 | $ | 19,506,183 | ||||
| Accumulated deficit | $ | (174,158,647 | ) | $ | (144,500,615 | ) | ||
| Total stockholders' equity | $ | 22,000,805 | $ | 26,130,947 |