PDS Biotechnology Corporation (Nasdaq: PDSB), a clinical-stage
immunotherapy company developing novel cancer therapies and
infectious disease vaccines based on the Company’s proprietary
Versamune® T-cell activating technology, will discuss its financial
results for the quarter ended September 30, 2021 and provide a
business update on its conference call today.
Recent Business Highlights:
- Achieved several milestones in the
VERSATILE-002 Phase 2 Combination Trial of PDS0101-KEYTRUDA® for
recurrent and/or metastatic human papillomavirus (HPV)16-associated
head and neck cancer. These milestones include:
- Achievement of the preliminary safety benchmark for the first
12 patients
- Completion of enrollment for the first stage of the checkpoint
inhibitor naïve arm (1st line treatment of recurrent or metastatic
head and neck cancer).
- Initiated enrollment of the second arm of the study addressing
checkpoint inhibitor refractory patients (2nd line treatment of
recurrent or metastatic head and neck cancer)
- Completed a licensing agreement
with the National Cancer Institute (NCI) for intellectual property
related to the NCI’s proprietary T-cell receptor gamma alternate
reading frame protein (TARP) tumor antigen for use in PDS0102.
- PDS0102 is being developed to treat prostate cancer, breast
cancer and acute myeloid leukemia or AML.
- PDS0102 has demonstrated powerful induction of TARP-specific
killer T-cells in preclinical studies.
- Entered agreement to license COBRA
(Computationally Optimized Broadly Reactive Antigen) antigens from
the University of Georgia for use in the development of PDS0202, a
novel Versamune®-based universal flu vaccine.
- Announced temporary administrative
suspension of enrollment into the NCI-led study of the PDS0101
triple combination. PDS Biotech continues to be in contact with the
NCI. Treatment of already enrolled patients has continued without
interruption.
- Announced the hiring of Matthew
Hill as Chief Financial Officer, who has more than 25 years of
experience in finance and operational leadership roles for life
sciences companies.
“PDS Biotech has continued to build on its
momentum from the interim data of the last quarter in 2nd and 3rd
line treatment of HPV16-positive anal, cervical, head and neck,
vaginal and vulvar cancers,” commented Dr. Frank Bedu-Addo,
President and Chief Executive Officer of PDS Biotech. “We have
achieved numerous clinical milestones, and formalized agreements
with development partners to continue to progress both our
Versamune®-based oncology pipeline and our Versamune®-based
infectious diseases pipeline. We also welcomed Matthew Hill as our
new Chief Financial Officer. Matt has decades of experience as a
financial leader in publicly traded life sciences companies and
will be a key player in our next phase of growth. The groundwork
has been laid for the execution of multiple pipeline development
milestones in 2022 and into 2023.”
Third Quarter 2021 Financial
Results
PDS Biotech reported a net loss of approximately
$7.0 million, or $(0.24) per basic and diluted share, for the three
months ended September 30, 2021, compared to a net loss of
approximately $3.9 million, or $(0.21) per basic and diluted share,
for the three months ended September 30, 2020.
Research and development expenses increased to
approximately $3.7 million for the three months ended September 30,
2021 from approximately $2.1 million for the three months ended
September 30, 2020. The increase of $1.6 million was primarily
attributable to an increase of $0.7 million in personnel costs of
which $0.5 million was stock compensation costs, and $0.9 million
in costs related to clinical studies.
General and administrative expenses increased to
approximately $3.2 million for the three months ended September 30,
2021 from approximately $1.8 million for the three months ended
September 30, 2020. The increase of $1.4 million is primarily
attributable to an increase in personnel costs of $1.6 million, of
which $1.0 million was stock compensation costs and $0.4 million
was severance, partially offset by a decrease in professional fees
of $0.2 million.
PDS Biotech’s cash and cash equivalents as
of September 30, 2021, were approximately $69.7 million.
Conference Call and Webcast
The conference call is scheduled to begin at
8:00 am ET on Wednesday, November 10, 2021. Participants should
dial 877-407-3088 (United States) or 201-389-0927 (International)
and mention PDS Biotechnology. A live webcast of the conference
call will also be available on the investor relations page of the
Company's corporate website at www.pdsbiotech.com.
After the live webcast, the event will be
archived on PDS Biotech’s website for 6 months. In addition, a
telephonic replay of the call will be available for 6 months. The
replay can be accessed by dialing 877-660-6853 (United States) or
201-612-7415 (International) with confirmation code 13722558.
About PDS Biotechnology
PDS Biotech is a clinical-stage immunotherapy
company developing a growing pipeline of cancer immunotherapies
based on the Company’s proprietary Versamune® T-cell activating
technology platform. Our Versamune®-based products have
demonstrated the potential to overcome the limitations of current
immunotherapy by inducing in vivo, large quantities of
high-quality, highly potent polyfunctional tumor specific CD4+
helper and CD8+ killer T-cells. PDS Biotech has developed multiple
therapies, based on combinations of Versamune® and disease-specific
antigens, designed to train the immune system to better recognize
diseased cells and effectively attack and destroy them. The
company’s pipeline products address various cancers including
breast, colon, lung, prostate and ovarian cancers. To learn more,
please visit www.pdsbiotech.com or follow us on Twitter at
@PDSBiotech.
About PDS0101
PDS Biotech’s lead candidate, PDS0101, combines
the utility of the Versamune® platform with targeted antigens in
HPV-expressing cancers. In partnership with Merck & Co., PDS
Biotech is evaluating a combination of PDS0101 and KEYTRUDA® in a
Phase 2 study in first-line treatment of recurrent or metastatic
head and neck cancer, and also in second line treatment of
recurrent or metastatic head and neck cancer in patients who have
failed prior checkpoint inhibitor therapy. PDS Biotech is also
conducting a Phase 2 clinical study in both second- and third-line
treatment of multiple advanced HPV-associated cancers with the
National Cancer Institute (NCI). A third phase 2 clinical trial in
first line treatment of locally advanced cervical cancer is being
performed with The University of Texas, MD Anderson Cancer
Center.
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 PDS0101, PDS0203 and other Versamune® based
products; the future success of such trials; the successful
implementation of the Company’s research and development programs
and collaborations, including any collaboration studies concerning
PDS0101, PDS0203 and other Versamune® based products and the
Company’s or monitoring committees’ or other third parties’
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, significance of milestones, and
completion of the trials (including our ability to fully fund our
disclosed clinical trials, which assumes no material changes to our
currently projected expenses), futility analyses, presentations at
conferences and data reported in an abstract, and receipt of
interim results, 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 acceptance by the market of the
Company’s product candidates, if approved; the timing of and the
Company’s ability to obtain and maintain U.S. Food and Drug
Administration or other regulatory authority approval of, or other
action with respect to, the Company’s product candidates; and other
factors, including legislative, regulatory, political and economic
developments not within the Company’s control, including unforeseen
circumstances or other disruptions to normal business operations
arising from or related to COVID-19. 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 risk factors included in the Company’s
annual and periodic reports filed with the SEC. 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.
Media & Investor Relations
Contact:
Deanne RandolphPDS BiotechPhone: +1 (908)
517-3613Email: drandolph@pdsbiotech.com
Rich CockrellCG CapitalPhone: +1 (404)
736-3838Email: pdsb@cg.capital
PDS BIOTECHNOLOGY CORPORATION AND
SUBSIDIARIESCondensed Consolidated
Balance Sheets
|
September 30,2021 |
|
December 31,2020 |
ASSETS |
(unaudited) |
|
|
Current assets: |
|
|
|
Cash and cash equivalents |
$ |
69,744,004 |
|
|
$ |
28,839,565 |
|
Prepaid expenses and other |
|
1,596,810 |
|
|
|
1,497,665 |
|
Total current assets |
|
71,340,814 |
|
|
|
30,337,230 |
|
|
|
|
|
|
|
Property and equipment, net |
|
1,037 |
|
|
|
5,443 |
|
Operating lease right-to-use asset |
|
406,171 |
|
|
|
547,706 |
|
|
|
|
|
|
|
Total assets |
$ |
71,748,022 |
|
|
$ |
30,890,379 |
|
|
|
|
|
|
|
LIABILITIES AND STOCKHOLDERS’
EQUITY |
|
|
|
|
|
LIABILITIES |
|
|
|
|
|
Current liabilities: |
|
|
|
|
|
Accounts payable |
$ |
1,445,585 |
|
|
$ |
1,415,224 |
|
Accrued expenses |
|
1,923,846 |
|
|
|
1,735,322 |
|
Operating lease obligation-short term |
|
207,717 |
|
|
|
119,904 |
|
Total current liabilities |
|
3,577,148 |
|
|
|
3,270,450 |
|
|
|
|
|
|
|
Noncurrent liability: |
|
|
|
|
|
Operating lease obligation-long term |
|
313,976 |
|
|
|
490,353 |
|
|
|
|
|
|
|
Total Liabilities |
$ |
3,891,124 |
|
|
$ |
3,760,803 |
|
|
|
|
|
|
|
STOCKHOLDERS’ EQUITY |
|
|
|
|
|
Common stock, $0.00033 par value, 75,000,000 shares authorized at
September 30, 2021 and December 31, 2020, 28,435,067 shares and
22,261,619 shares issued and outstanding at September 30, 2021 and
December 31, 2020, respectively |
|
9,383 |
|
|
|
7,346 |
|
Additional paid-in capital |
|
122,231,115 |
|
|
|
70,907,315 |
|
Accumulated deficit |
|
(54,383,600 |
) |
|
|
(43,785,085 |
) |
Total stockholders’ equity |
|
67,856,898 |
|
|
|
27,129,576 |
|
|
|
|
|
|
|
Total liabilities and stockholders’ equity |
$ |
71,748,022 |
|
|
$ |
30,890,379 |
|
PDS BIOTECHNOLOGY CORPORATION AND
SUBSIDIARIESCondensed Consolidated Statements of
Operations and Comprehensive
Loss(Unaudited)
|
Three Months EndedSeptember 30, |
|
Nine Months EndedSeptember 30, |
|
2021 |
|
2020 |
|
2021 |
|
2020 |
Operating expenses: |
|
|
|
|
|
|
|
Research and development expenses |
$ |
3,687,999 |
|
|
$ |
2,060,815 |
|
|
$ |
7,865,249 |
|
|
$ |
5,446,718 |
|
General and administrative expenses |
|
3,274,325 |
|
|
|
1,846,214 |
|
|
|
7,252,371 |
|
|
|
5,428,098 |
|
Total operating expenses |
|
6,962,324 |
|
|
|
3,907,029 |
|
|
|
15,117,620 |
|
|
|
10,874,816 |
|
|
|
|
|
|
|
|
|
|
|
|
|
Loss from operations |
|
(6,962,324 |
) |
|
|
(3,907,029 |
) |
|
|
(15,117,620 |
) |
|
|
(10,874,816 |
) |
|
|
|
|
|
|
|
|
|
|
|
|
Other income: |
|
|
|
|
|
|
|
|
|
|
|
Interest income |
|
1,358 |
|
|
|
1,207 |
|
|
|
2,617 |
|
|
|
54,242 |
|
|
|
|
|
|
|
|
|
|
|
|
|
Loss before income taxes |
|
(6,960,966 |
) |
|
|
(3,905,822 |
) |
|
|
(15,115,003 |
) |
|
|
(10,820,574 |
) |
Benefit from income taxes |
|
– |
|
|
|
– |
|
|
|
4,516,488 |
|
|
|
– |
|
Net loss and comprehensive
loss |
|
(6,960,966 |
) |
|
|
(3,905,822 |
) |
|
|
(10,598,515 |
) |
|
|
(10,820,574 |
) |
|
|
|
|
|
|
|
|
|
|
|
|
Per share information: |
|
|
|
|
|
|
|
|
|
|
|
Net loss per share, basic and
diluted |
$ |
(0.24 |
) |
|
$ |
(0.21 |
) |
|
$ |
(0.43 |
) |
|
$ |
(0.73 |
) |
|
|
|
|
|
|
|
|
|
|
|
|
Weighted average common shares
outstanding, basic and diluted |
|
28,425,850 |
|
|
|
18,961,619 |
|
|
|
24,639,299 |
|
|
|
14,892,764 |
|
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