false
0001472091
0001472091
2024-05-15
2024-05-15
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UNITED STATES
SECURITIES AND EXCHANGE COMMISSION
WASHINGTON, DC 20549
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FORM
8-K
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CURRENT REPORT
Pursuant to Section 13 or 15(d) of the
Securities Exchange Act of 1934
Date of Report (Date of earliest event reported):
May 15, 2024
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PDS BIOTECHNOLOGY CORPORATION
(Exact Name of Registrant as Specified in Charter)
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Delaware 001-37568 26-4231384
(State or Other Jurisdiction of Incorporation) (Commission File Number) (I.R.S. Employer Identification No.)
303A College Road East
,
Princeton
,
NJ
08540
(Address of Principal Executive Offices, and Zip Code)
(
800
)
208-3343
Registrant's Telephone Number, Including Area Code
(Former Name or Former Address, if Changed Since Last Report)
Check the appropriate box below if the Form 8-K filing is intended to
simultaneously satisfy the filing obligation of the registrant under any of
the following provisions (
see
General Instruction A.2. below):
Written communication pursuant to Rule 425 under the Securities Act (17 CFR 230.425)
Soliciting material pursuant to Rule 14a-12 under the Exchange Act (17 CFR 240.14a-12)
Pre-commencement communication pursuant to Rule 14d-2(b) under the Exchange Act (17 CFR 240.14d-2(b))
Pre-commencement communication pursuant to Rule 13e-4(c) under the Exchange Act (17 CFR 240.13e-4(c))
Securities registered pursuant to Section 12(b) of the Act:
Title of each class Trading Symbol(s) Name of each exchange on which
registered
Common Stock, par value $0.00033 per share PDSB The Nasdaq Stock Market LLC
Indicate by check mark whether the registrant is an emerging growth company as
defined in Rule 405 of the Securities Act of 1933 (17 CFR (s)230.405 of this
chapter) or Rule 12b-2 of the Securities Exchange Act of 1934 (17 CFR
(s)240.12b-2 of this chapter).
Emerging growth company
If an emerging growth company, indicate by check mark if the registrant has
elected not to use the extended transition period for complying with any new
or revised financial accounting standards provided pursuant to Section 13(a)
of the Exchange Act. Yes No
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Item 2.02 Results of Operation and Financial Condition.
On May 15, 2024, PDS Biotechnology Corporation (the "Company") issued a press
release announcing a business update and its financial results for the quarter
ended March 31, 2024. The Company is furnishing a copy of the press release,
which is attached hereto as Exhibit 99.1.
In accordance with General Instruction B.2 of Form 8-K, the information set
forth in this Current Report on Form 8-K (including Exhibit 99.1) is deemed to
be "furnished" and shall not be deemed to be "filed" for purposes of Section
18 of the Securities and Exchange Act of 1934, as amended (the "Exchange
Act"), or otherwise subject to the liabilities of the section, nor shall it be
deemed incorporated by reference into any filing made by the Company under the
Exchange Act or Securities Act of 1933, as amended, except as shall be
expressly set forth by specific reference in such a filing.
Item 9.01 Financial Statements and Exhibits.
(d) Exhibits.
Exhibit Description
Number
99.1 Press Release dated May 15, 2024.
104 Cover Page Interactive Data File (embedded within the Inline XBRL document).
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Signature
Pursuant to the requirements of the Securities Exchange Act of 1934, the
registrant has duly caused this report to be signed on its behalf by the
undersigned hereunto duly authorized.
PDS BIOTECHNOLOGY CORPORATION
Date: May 15, 2024 By:
/s/ Frank Bedu-Addo, Ph.D.
Name: Frank Bedu-Addo, Ph.D.
Title: President and Chief Executive Officer
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Exhibit 99.1
PDS Biotech Provides Business Update and Reports First Quarter 2024 Financial
Results
Provided Positive, Updated Data from Phase 2 VERSATILE-002 Clinical Trial with
Versamune(R) HPV in Combination with KEYTRUDA(R) in Recurrent or Metastatic
Head and Neck Cancer
Expanded Global Intellectual Property Surrounding Versamune(R) Platform
PRINCETON, N.J., May 15, 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 first quarter of 2024. The press
release will be available in the Investor Relations section of the Company's
website at www.pdsbiotech.com.
Recent Developments
. Hosted a Key Opinion Leader event on May 8, 2024 during which prominent
experts in head and neck squamous cell cancer ("HNSCC") discussed
positive, updated VERSATILE-002 data and the unmet need in
HPV16-positive HNSCC. A replay of the event can be found
here
.
. Announced updated results from the VERSATILE-002 Phase 2 trial evaluating first line
treatment of patients with HPV16-positive recurrent or metastatic HNSCC using Versamune
(R)
HPV + KEYTRUDA
(R)
(pembrolizumab) (n=53).
o Median overall survival is 30 months; Published results for immune checkpoint inhibitors are 7-18 months.
o The cohort met its primary endpoint of best overall response (BOR).
o BOR by investigator assessment is 34% (Combined Positive Score (CPS) e1;
n=18/53); 48% (CPSe20; n=10/21); Published results for ICIs are <20% (CPS
>
1) and <25% (CPSe20).
CPS is used to assess PD-L1 expression
o Progression free survival is 6.3 months (CPSe1); 14.1 months (CPSe20);
Published results for immune checkpoint inhibitors 2-3 months.
o VERSATILE-002 data to date indicate a durable response in first line recurrent or metastatic HNSCC patients with CPSe1.
o The combination of Versamune
(R)
HPV + pembrolizumab was well tolerated.
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. Announced an updated clinical strategy with a two-part registrational trial focused on the triple combination of Versamune
(R)
HPV + PDS01ADC + pembrolizumab as a first line treatment in HPV16-positive recurrent or metastatic HNSCC.
o PDS01ADC is the Company's novel, investigational tumor-targeting IL-12-fused
antibody-drug conjugate (ADC), which has shown promise in a clinical trial of Versamune
(R)
HPV + PDS01ADC + an investigational ICI
conducted by the National Cancer Institute.
o Part one of the clinical trial will focus on dose optimization with a data readout based on safety and objective response rate.
o The randomized second part of the trial will include an interim data readout with overall survival as its primary endpoint.
. Further strengthened management with the addition of Stephan Toutain, M.S., MBA, as Chief Operating
Officer. Mr. Toutain brings extensive operational and commercial experience to PDS Biotech.
Versamune(R) Platform Intellectual Property
. Company received patents granted by the Israel Patent Office and IP Australia that will extend protections for the
Company's novel investigational T cell activating Versamune(R) platform through Dec. 2038 and Nov. 2036, respectively.
o The Israel Patent Office granted patent No. 275154 titled, "Methods and compositions comprising
cationic lipids for stimulating type I interferon genes," extending protections for compositions using
the Versamune(R) platform and comprising of cationic lipid for activating type I interferons. This
patent covers all formulations and compositions that include Versamune to activate a T cell response.
o IP Australia granted patent No. 2016354590 titled, "Lipids as synthetic vectors to enhance antigen
processing and presentation ex-vivo in dendritic cell therapy." This patent covers the use
of Versamune(R) compositions that reduce the populations of immune suppressive cells in the tumor
and its application for the development of dendritic cell-based approaches to immunotherapy.
First Quarter 2024 Financial Results
Reported net loss was approximately $10.6 million, or $0.30 per basic share
and diluted share, for the three months ended March 31, 2024, compared to a
net loss of $9.7 million, or $0.32 per basic share and diluted share, for the
three months ended March 31, 2023. The increase was due to higher operating
and net interest expenses.
Research and development expenses increased to approximately $6.7 million for
the three months ended March 31, 2024, from $5.8 million for the three months
ended March 31, 2023. The increase of $0.9 million was primarily attributable
to an increase of $1.2 million in clinical studies and medical affairs offset
by a decrease of $0.1 million in personnel costs, $0.1 million in professional
fees and $0.1 million in manufacturing expenses.
General and administrative expenses decreased to approximately $3.4 million
for the three months ended March 31, 2024, from approximately $3.6 million for
the three months ended March 31, 2023. The decrease of $0.2 million was
primarily attributable to an increase of $0.3 million in professional fees
offset by a decrease of $0.5 million in personnel costs.
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Total operating expenses increased to approximately $10.1 million for the
three months ended March 31, 2024 from $9.4 million for the three months ended
March 31, 2023.
Net interest expenses increased to approximately $0.5 million for the three
months ended March 31, 2024 from $0.2 million for the three months ended March
31, 2023.
Cash and cash equivalents as of March 31, 2024, totaled approximately $66.6
million.
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 IL-12 fused antibody drug conjugate
(ADC) PDS01ADC and T-cell activator Versamune
(R)
HPV in regimen with a standard-of-care immune checkpoint inhibitor. We believe
that proof-of-concept long-term data have shown positive survival results and
tumor shrinkage with this combination and indicate favorable tolerability.
We believe that with a novel investigational "inside-outside" mechanism, the
PDS01ADC and Versamune
(R)
HPV 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. We believe that data from
more than 350 patients, as well as ongoing clinical trials across multiple
tumor types and standard treatment regimens, have validated the potential for
both platforms and point to potential broad utility.
Our Infectimune
(R)
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
.
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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
(R)
and Infectimune
(R)
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
(R)
and Infectimune
(R)
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
(R)
and Infectimune
(R)
are registered trademarks of PDS Biotechnology Corporation.
Keytruda
(R)
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
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PDS BIOTECHNOLOGY CORPORATION AND SUBSIDIARY
Unaudited Consolidated Statements of Operations and Comprehensive Loss
Three Months Ended March 31,
2024 2023
Operating expenses:
Research and development expenses $ 6,704,164 $ 5,843,686
General and administrative expenses $ 3,393,463 $ 3,578,728
Total operating expenses $ 10,097,627 $ 9,422,414
Loss from operations $ (10,097,627 ) $ (9,422,414 )
Interest income (expense), net
Interest income $ 668,895 $ 729,341
Interest expense $ (1,174,745 ) $ (966,845 )
Interest income (expense), net $ (505,850 ) $ (237,504 )
Net loss and comprehensive loss $ (10,603,477 ) $ (9,659,918 )
Per share information:
Net loss per share, basic and diluted $ (0.30 ) $ (0.32 )
Weighted average common shares outstanding basic and diluted 34,815,870 30,428,053
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PDS BIOTECHNOLOGY CORPORATION AND SUBSIDIARY
Unaudited selected Balance Sheet Data
March 31, December 31,
2024 2023
Cash and cash equivalents $ 66,634,417.00 $ 56,560,517.00
Working Capital $ 53,622,075.00 $ 45,425,100.00
Total assets $ 69,006,366.00 $ 59,390,082.00
Long term Debt $ 16,651,420.00 $ 19,506,183.00
Accumulated Deficit $ (155,104,092.00 ) $ (144,500,613.00 )
Total stockholders' equity $ 37,183,045.00 $ 26,130,949.00
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