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, today announced its
financial results for the first quarter ended March 31, 2020 and
provided a business update.
First Quarter 2020 and Recent Business
Highlights
- Initiated novel vaccine development
programs for COVID-19 and universal influenza;
- Announced pre-clinical
collaboration with Farmacore Biotechnology for tuberculosis;
- Delayed initiation of Phase 2
VERSATILE-002 trial for PDS0101 in recurrent/metastatic head and
neck cancer due to the global COVID-19 pandemic;
- Secured the U.S. composition of
matter patent for the Versamune® platform;
- Expanded the previously disclosed
Cooperative Research and Development Agreement with the National
Cancer Institute to include preclinical and clinical development of
PDS0103;
- Appointed Kamil Ali-Jackson, Esq.
and Dr. Ilian Iliev to the Board of Directors; and
- Successfully completed an
underwritten public offering of our common stock in February 2020
with net proceeds of approximately $11.9 million after deducting
underwriting discounts and commissions, not including other
offering expenses.
“We have continued to leverage the versatility
and potency of our Versamune® platform, as we expand our
development program to include vaccines to protect against
infectious diseases such as COVID-19 and influenza. We believe that
Versamune’s® ability to induce a superior range of protective
immune responses - including neutralizing antibodies, killer
T-cells and memory T-cells - uniquely positions PDS to develop more
effective vaccines to provide long-term protection against the
spread of agents with pandemic potential. We have recently
initiated pre-clinical testing for our COVID-19 vaccine candidates
and are in active discussions with both government agencies and
NGOs to determine the most expeditious path forward,” commented Dr.
Frank Bedu-Addo, President and Chief Executive Officer of PDS
Biotech.
“We remain committed to our immuno-oncology
programs, including two upcoming Phase 2 studies for PDS0101 with
our partners at the National Cancer Institute. We also look forward
to initiating our third Phase 2 program evaluating the combination
of PDS0101 and Merck’s KEYTRUDA® in HPV16-associated head and neck
cancer for first line treatment of recurrent/metastatic disease
when conditions to conduct the study improve,” Dr. Bedu-Addo
concluded.
First Quarter 2020 Financial
Review
For the first quarter of 2020, net loss was
approximately $4.0 million, or $0.39 per basic share and $0.39 per
diluted share, compared to a net income of approximately $6.8
million, or $1.82 per basic share and $1.47 per diluted share for
the first quarter of 2019 related to the reverse merger transaction
with Edge Therapeutics.
Research and development expenses totaled
approximately $1.9 million for the first quarter of 2020, compared
to approximately $1.0 million for the same period in 2019, an
increase of 91%.
For the first quarter of 2020, general and
administrative expenses were approximately $2.1 million compared
with approximately $3.9 million for the first quarter of 2019, a
decrease of 47%.
Total operating expenses for the first quarter
of 2020 were approximately $4.0 million, compared to total
operating expenses of approximately $4.9 million for the same
period in 2019, a decrease of 18%.
As of March 31, 2020, the Company’s cash balance
was approximately $21.0 million. This amount includes the
approximately $11.9 million in net proceeds after deducting
underwriting discounts and commissions, not including other
offering expenses from PDS Biotech’s underwritten public offering
including the exercise of the underwriters’ overallotment option,
which closed on February 14, 2020.
About PDS Biotechnology
PDS Biotech is a clinical-stage immunotherapy
company with a growing pipeline of cancer immunotherapies and
infectious disease vaccines based on the Company’s proprietary
Versamune® T-cell activating technology platform. Versamune®
effectively delivers disease-specific antigens for in vivo uptake
and processing, while also activating the critical type 1
interferon immunological pathway, resulting in production of potent
disease-specific killer T-cells as well as neutralizing antibodies.
PDS Biotech has engineered multiple therapies, based on
combinations of Versamune® and disease-specific antigens, designed
to train the immune system to better recognize disease cells and
effectively attack and destroy them. To learn more, please visit
www.pdsbiotech.com or follow us on Twitter at @PDSBiotech.
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,” and
other similar expressions among others. Statements that are not
historical facts are forward-looking statements. 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 timing for the Company or its
partners to initiate the planned clinical trials for its lead
assets, PDS0101; the Company’s interpretation of the results of its
Phase 1 trial for PDS0101 and whether such results are sufficient
to support additional trials or 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 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
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
Tram Bui / Alexander LoboThe Ruth GroupPhone: +1
(646) 536-7035 / +1 (646) 536-7037Email: tbui@theruthgroup.com /
alobo@theruthgroup.com
(Financial Statements to Follow)
PDS BIOTECHNOLOGY CORPORATION
Consolidated Balance Sheets
Balance Sheets |
|
|
|
|
March 31,
2020 |
December 31,
2019 |
|
ASSETS |
|
|
|
Current assets: |
|
|
|
Cash and cash equivalents |
21,037,806 |
|
12,161,739 |
|
|
Prepaid expenses and other current assets |
2,879,378 |
|
2,308,462 |
|
|
Total current assets |
23,917,184 |
|
14,470,201 |
|
|
|
|
|
|
Property and equipment, net |
17,149 |
|
21,051 |
|
|
|
|
|
|
Total
assets |
23,934,333 |
|
14,491,252 |
|
|
|
|
|
|
LIABILITIES AND STOCKHOLDERS' EQUITY |
|
|
|
LIABILITIES |
|
|
|
Current liabilities: |
|
|
|
Accounts payable |
2,556,703 |
|
1,197,720 |
|
|
Accrued expenses |
1,220,191 |
|
1,097,640 |
|
|
Restructuring reserve |
269,887 |
|
498,185 |
|
|
Total current liabilities |
4,046,781 |
|
2,793,545 |
|
|
|
|
|
|
Total liabilities: |
4,046,781 |
|
2,793,545 |
|
|
|
|
|
|
STOCKHOLDERS' EQUITY |
|
|
|
Common stock, $0.00033 par value, 75,000,000 shares authorized at
March 31, 2020 and December 31, 2019, 15,350,445 shares and
5,281,237 shares issued and outstanding at March 31, 2020 and
December 31, 2019, respectively |
5,064 |
|
1,742 |
|
|
Additional paid-in capital |
52,805,601 |
|
40,633,670 |
|
|
Accumulated deficit |
(32,923,113 |
) |
(28,937,705 |
) |
|
Total stockholders' equity |
19,887,552 |
|
11,697,707 |
|
|
|
|
|
|
Total liabilities and stockholders' equity |
23,934,333 |
|
14,491,252 |
|
|
|
|
|
|
PDS BIOTECHNOLOGY CORPORATION
Consolidated Statements of Operations and Comprehensive
Loss
(Unaudited)
|
|
|
|
|
Three Months
Ended |
Three Months
Ended |
|
|
March 31,
2020 |
March 31,
2019 |
|
Operating
expenses: |
|
|
|
Research and development expenses |
1,971,679 |
|
1,030,003 |
|
|
General and administrative expenses |
2,060,148 |
|
3,905,877 |
|
|
|
|
|
|
Total
operating expenses |
4,031,827 |
|
4,935,880 |
|
|
|
|
|
|
Loss from
operations |
(4,031,827 |
) |
(4,935,880 |
) |
|
|
|
|
|
Other income
(expense): |
|
|
|
Gain on bargain purchase |
- |
|
11,729,882 |
|
|
Interest income |
46,419 |
|
23,302 |
|
|
Interest expense |
- |
|
(606 |
) |
|
|
|
|
|
Net (loss)
and comprehensive gain |
(3,985,408 |
) |
6,816,698 |
|
|
|
|
|
|
Per share
information: |
|
|
|
Net income
(loss) per share, basic and diluted |
(0.39 |
) |
1.82 |
|
|
Net income
(loss) per share, diluted |
(0.39 |
) |
1.47 |
|
|
|
|
|
|
Weighted
average common shares outstanding, basic and diluted |
10,314,761 |
|
3,748,325 |
|
|
Weighted
average common shares outstanding, diluted |
10,314,761 |
|
4,625,295 |
|
|
|
|
|
|
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