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 March 31, 2021 and provide a business
update on its conference call today.
Recent Business Highlights:
- National
Cancer Institute to present interim efficacy and safety data of
PDS0101 Phase 2 clinical trial in an oral presentation at the
American Society of Clinical Oncology (ASCO) 2021 Annual Meeting on
June 7, 2021. This trial is evaluating PDS0101 with two clinical
stage immunotherapies from EMD Serono, a first in class
bifunctional checkpoint inhibitor Bintrafusp Alfa (M7824) and an
antibody conjugated cytokine M9241 (NHS-IL12), in patients with all
types of advanced HPV-associated cancers, whose cancer has returned
or spread after treatment.
- COVID-19 consortium received a
commitment from the Secretary for Research and Scientific Training
of The Ministry of Science, Technology and Innovation of Brazil
(MCTI) to fund up to approximately US$60 million to support the
clinical development and commercialization of a Versamune®-based
COVID-19 vaccine by Farmacore in Brazil.
“We look forward to the presentation of
preliminary efficacy and safety data from the National Cancer
Institute (NCI)-led Phase 2 combination study of PDS0101 at the
ASCO conference in early June. ASCO provides an important
opportunity to present the potential of PDS0101 and the Versamune®
platform in oncology to the research and medical community,”
commented Dr. Frank Bedu-Addo, President and Chief Executive
Officer of PDS Biotech, “The presentation of the human clinical
efficacy data at ASCO is an important milestone both for PDS0101
and our entire Versamune®-based oncology pipeline.”
First Quarter 2021 Financial
ResultsPDS Biotech reported a net loss of approximately
$3.0 million, or $0.14 per basic share and diluted share, for the
three months ended March 31, 2021 compared to a net loss of
approximately $4.0 million, or $0.39 per basic share and diluted
share, for the three months ended March 31, 2020.
Research and development (R&D) expenses
decreased 28% to approximately $1.4 million for the three months
ended March 31, 2021 from approximately $2.0 million for the three
months ended March 31, 2020. The decrease of approximately $0.6
million in 2021 was primarily attributable to a decrease of $0.3
million in professional services and $0.3 million in clinical
studies.
General and administrative expenses decreased
21% to approximately $1.6 million for the three months ended March
31, 2021 from approximately $2.1 million for the three months ended
March 31, 2020. The decrease of approximately $0.5 million is
primarily attributable to a decrease in professional services of
approximately $0.7 million which includes legal fees of
approximately $0.2 million, offset by an increase of approximately
$0.2 million in personnel costs.
Total operating expenses decreased 24% to
approximately $3.0 million for the three months ended March 31,
2021 from approximately $4.0 million for the three months ended
March 31, 2020.
PDS Biotech’s cash balance as of March 31, 2021
was approximately $25.0 million.
Conference Call and WebcastThe
conference call is scheduled to begin at 8:00 am ET on Thursday,
May 13, 2021. Participants should dial 877-407-3088 (United States)
or 201-389-0927 (International) and mention PDS Biotech.
Participants can also access the conference call via webcast on the
investor relations page of the Company’s corporate website
(link).
The event will be archived in the investor
relations section of 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
13716518.
About PDS Biotech
PDS Biotech is a clinical-stage immunotherapy
company developing a growing pipeline of cancer immunotherapies and
infectious disease vaccines based on the Company’s proprietary
Versamune® T-cell activating technology platform. Our
Versamune®-based products 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. Our immuno-oncology product candidates are initially being
studied in combination therapy to potentially enhance efficacy
without compounding toxicity across a range of cancer types. The
Company’s lead investigational cancer immunotherapy product PDS0101
is currently in Phase 2 clinical studies in HPV-associated cancers.
To learn more, please visit www.pdsbiotech.com or follow us on
Twitter at @PDSBiotech.
Forward Looking StatementsThis
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 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 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; 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 BiotechnologyPhone: +1 (908) 517-3613Email:
drandolph@pdsbiotech.com
Rich CockrellCG CapitalPhone: +1 (404) 736-3838 Email:
pdsb@cg.capital
PDS BIOTECHNOLOGY CORPORATION AND
SUBSIDIARIES
Condensed Consolidated
Balance Sheets
|
March 31, 2021 |
|
December 31, 2020 |
ASSETS |
(unaudited) |
|
|
Current assets: |
|
|
|
Cash and cash equivalents |
$ |
25,037,374 |
|
|
$ |
28,839,565 |
|
Prepaid expenses and other |
|
2,219,514 |
|
|
|
1,497,665 |
|
Total current assets |
|
27,256,888 |
|
|
|
30,337,230 |
|
|
|
|
|
|
|
Property and equipment, net |
|
3,583 |
|
|
|
5,443 |
|
Operating lease right-to-use asset |
|
501,194 |
|
|
|
547,706 |
|
|
|
|
|
|
|
Total assets |
$ |
27,761,665 |
|
|
$ |
30,890,379 |
|
|
|
|
|
|
|
LIABILITIES AND STOCKHOLDERS' EQUITY |
|
|
|
|
|
LIABILITIES |
|
|
|
|
|
Current liabilities: |
|
|
|
|
|
Accounts payable |
$ |
950,598 |
|
|
$ |
1,415,224 |
|
Accrued expenses |
|
1,854,795 |
|
|
|
1,735,322 |
|
Operating lease obligation-short term |
|
123,654 |
|
|
|
119,904 |
|
Total current liabilities |
|
2,929,047 |
|
|
|
3,270,450 |
|
|
|
|
|
|
|
Noncurrent liability: |
|
|
|
|
|
Operating lease obligation-long term |
|
458,291 |
|
|
|
490,353 |
|
|
|
|
|
|
|
Total Liabilities: |
$ |
3,387,338 |
|
|
$ |
3,760,803 |
|
|
|
|
|
|
|
|
|
|
|
|
|
STOCKHOLDERS' EQUITY |
|
|
|
|
|
Common stock, $0.00033 par value, 75,000,000 shares authorized at
March 31, 2021 and December 31, 2020, 22,278,261 shares and
22,261,619 shares issued and outstanding at March 31, 2021 and
December 31, 2020, respectively |
|
7,346 |
|
|
|
7,346 |
|
Additional paid-in capital |
|
71,200,684 |
|
|
|
70,907,315 |
|
Accumulated deficit |
|
(46,833,703 |
) |
|
|
(43,785,085 |
) |
Total stockholders' equity |
|
24,374,327 |
|
|
|
27,129,576 |
|
|
|
|
|
|
|
Total liabilities and stockholders' equity |
$ |
27,761,665 |
|
|
$ |
30,890,379 |
|
|
|
PDS BIOTECHNOLOGY CORPORATION AND
SUBSIDIARIES
Condensed Consolidated Statements of
Operations and Comprehensive Loss
(Unaudited)
|
Three Months Ended March 31, |
|
2021 |
|
2020 |
Operating expenses: |
|
|
|
|
|
Research and development expenses |
$ |
1,413,057 |
|
|
$ |
1,971,679 |
|
General and administrative expenses |
|
1,636,216 |
|
|
|
2,060,148 |
|
|
|
|
|
|
|
Total operating expenses |
|
3,049,273 |
|
|
|
4,031,827 |
|
|
|
|
|
|
|
Loss from operations |
|
(3,049,273 |
) |
|
|
(4,031,827 |
) |
|
|
|
|
|
|
Other income |
|
|
|
|
|
Interest income |
|
655 |
|
|
|
46,419 |
|
|
|
|
|
|
|
Net loss and comprehensive loss |
$ |
(3,048,618 |
) |
|
$ |
(3,985,408 |
) |
|
|
|
|
|
|
Per share information: |
|
|
|
|
|
Net loss per share, basic |
$ |
(0.14 |
) |
|
$ |
(0.39 |
) |
Net loss per share, diluted |
$ |
(0.14 |
) |
|
$ |
(0.39 |
) |
|
|
|
|
|
|
Weighted average common shares
outstanding, basic |
|
22,263,838 |
|
|
|
10,314,761 |
|
Weighted average common shares
outstanding, diluted |
|
22,263,838 |
|
|
|
10,314,761 |
|
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