PDS Biotechnology Corporation (“PDS Biotechnology”) (Nasdaq: PDSB),
a clinical-stage immuno-oncology company pioneering the development
of novel multifunctional immunotherapeutic products, today
announced its financial results for the first quarter ended March
31, 2019.
Q1 2019 and Recent Business
Highlights
- Successfully completed merger with Edge Therapeutics and listed
on the Nasdaq Capital Market;
- Strengthened Board of Directors with the appointment of
industry veteran Stephen Glover.
“The first quarter of 2019 was an exciting
period for PDS, as we successfully completed our merger with Edge
Therapeutics and became a public company. Simultaneously, we
strengthened both our management team and Board of Directors with
industry veterans who we believe will help guide our strategic
direction moving forward,” commented Dr. Frank Bedu-Addo, President
and Chief Executive Officer of PDS Biotechnology. “As we look
ahead, we are preparing to initiate three clinical studies of
PDS0101 in the fourth quarter of this year, which includes; a
planned phase 2 combination study to evaluate PDS0101 in
combination with Keytruda® in the treatment of head and neck
cancer, a phase 2 study to evaluate PDS0101 in advanced
HPV-associated cancers, and an anticipated registration trial to
evaluate PDS0101 monotherapy in the treatment of high-grade
cervical dysplasia.”
First Quarter 2019 Financial
Review
For the first quarter of 2019, net income was
approximately $6.8 million, or $1.82 per basic share and $1.47 per
diluted share, compared to a net loss of approximately $(0.7)
million, or $(0.24) per basic and diluted share for the first
quarter of 2018.
Research and development expenses totaled
approximately $1.0 million for the first quarter of 2019, compared
to approximately $0.2 million for the same period in 2018, an
increase of 412%. These expenses include employee-related expenses,
licensing fees to use certain technology in PDS’ research and
development projects, costs of acquiring, developing and
manufacturing clinical trial materials, as well as fees paid to
consultants and various entities that perform certain research and
testing on PDS’ behalf.
For the first quarter of 2019, general and
administrative expenses were approximately $3.9 million compared
with approximately $0.5 million for the first quarter of 2018, an
increase of 629%. The increase is primarily attributable to an
increase in non-cash stock compensation expense of $2.3 million and
bonuses of $0.4 million. In addition, there was an increase in
D&O insurance of $0.1 million, professional consulting fees of
$0.1 million, as well as legal fees of $0.4 million.
Total operating expenses for the first quarter
of 2019 were approximately $4.9 million, compared to total
operating expenses of approximately $0.7 million for the same
period in 2018, an increase of 570%.
The Company recognized a gain on bargain
purchase of approximately $11.7 million in connection with the
merger with Edge. The gain represents the difference between the
book value of Edge assets compared to the cash value of stock
granted to legacy Edge shareholders.
As of March 31, 2019, the Company’s cash balance
was approximately $26.6 million.
About PDS BiotechnologyPDS
Biotechnology is a clinical stage immuno-oncology company with a
growing pipeline of clinical-stage immunotherapies to treat various
early-stage and late-stage cancers, including head and neck cancer,
cervical, anal, prostate, breast and other cancers.
PDS Biotechnology’s lead product candidate,
PDS0101 (Versamune®-HPV) is a proprietary clinical stage
immunotherapeutic administered by subcutaneous injection being
developed to treat HPV-associated cancers such as head and neck
cancers and anal cancers, both of which are widely reported to be
increasing in frequency over the last decade, as well as cervical,
penile, vaginal and vulvar cancers and their pre-cancerous
conditions. In a human Phase 1/2a clinical study, PDS0101
monotherapy demonstrated potent in-vivo induction of the critical
phenotype of tumor-attacking killer (CD8) T-cells, and induction of
memory T-cells. No dose-limiting toxicities were observed in this
study, suggesting potential for a rare combination of potency and
safety among immune-oncology therapeutics.
For additional information about PDS, 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,” 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 ability of the Company
to integrate Edge and PDS Biotechnology following the merger; the
Company’s ability to protect its intellectual property rights;
competitive responses to the completion of the merger; potential
adverse reactions or changes to business relationships resulting
from the completion of the merger; the Company’s ability to access
capital markets, the timing for the Company to initiate two
clinical trials for its lead asset, PDS0101; the successful
implementation of the Company’s research and development programs
and collaborations; the acceptance by the market of the Company’s
product candidates, if approved; 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 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: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
Condensed Consolidated Balance
Sheets
|
March 31, 2019 |
|
December 31, 2018 |
ASSETS |
(unaudited) |
|
|
Current assets: |
|
|
|
Cash and cash equivalents |
$ |
26,592,845 |
|
|
$ |
103,695 |
|
Prepaid expenses and other current assets |
|
1,313,931 |
|
|
|
156,628 |
|
Total current assets |
|
27,906,776 |
|
|
|
260,323 |
|
|
|
|
|
|
|
Property and equipment, net |
|
412,735 |
|
|
|
29,508 |
|
Intangible assets, net |
|
1,223,000 |
|
|
|
41,692 |
|
Right-to-use assets |
|
1,347,557 |
|
|
|
- |
|
Other assets |
|
155,670 |
|
|
|
12,800 |
|
|
|
|
|
|
|
Total assets |
$ |
31,045,738 |
|
|
$ |
344,323 |
|
|
|
|
|
|
|
LIABILITIES AND STOCKHOLDERS'
EQUITY |
|
|
|
|
|
LIABILITIES |
|
|
|
|
|
Current liabilities: |
|
|
|
|
|
Accounts payable |
$ |
2,665,266 |
|
|
$ |
1,412,951 |
|
Accrued expenses |
|
446,962 |
|
|
|
601,889 |
|
Restructuring reserve |
|
1,948,596 |
|
|
|
- |
|
Operating lease liability- short term |
|
477,300 |
|
|
|
- |
|
Total current liabilities |
|
5,538,124 |
|
|
|
2,014,840 |
|
|
|
|
|
|
|
Noncurrent liability: |
|
|
|
|
|
Deferred tax liability |
|
157,000 |
|
|
|
- |
|
Operating lease liability- long term |
|
902,972 |
|
|
|
- |
|
Convertible promissory notes payable |
|
- |
|
|
|
30,000 |
|
|
|
|
|
|
|
STOCKHOLDERS' EQUITY |
|
|
|
|
|
Preferred stock, 5,000,000 shares authorized at March 31, 2019 and
December 31, 2018, 0 outstanding |
|
- |
|
|
|
- |
|
Common stock, $0.00033 par value, 75,000,000 shares authorized at
March 31, 2019 and December 31, 2018, 5,172,938 shares and
3,417,187 shares issued and outstanding at March 31, 2019 and
December 31, 2018, respectively |
|
1,707 |
|
|
|
1,128 |
|
Additional paid-in capital |
|
38,642,411 |
|
|
|
19,311,529 |
|
Accumulated deficit |
|
(14,196,476 |
) |
|
|
(21,013,174 |
) |
Total stockholders' equity |
|
24,447,642 |
|
|
|
(1,700,517 |
) |
|
|
|
|
|
|
Total liabilities and stockholders' equity |
$ |
31,045,738 |
|
|
$ |
344,323 |
|
PDS BIOTECHNOLOGY CORPORATION |
Condensed Consolidated Statements of Operations and
Comprehensive Income (Loss) |
(Unaudited) |
|
Three Months Ended March 31, |
|
2019 |
|
2018 |
Operating expenses: |
|
|
|
Research and development expenses |
$ |
1,030,003 |
|
|
$ |
201,138 |
|
General and administrative expenses |
|
3,905,877 |
|
|
|
535,801 |
|
|
|
|
|
|
|
|
|
Total operating expenses |
|
4,935,880 |
|
|
|
736,939 |
|
|
|
|
|
|
|
|
|
Loss from operations |
|
(4,935,880 |
) |
|
|
(736,939 |
) |
|
|
|
|
|
|
|
|
Other income (expense): |
|
|
|
|
|
|
|
Gain on bargain purchase |
|
11,729,882 |
|
|
|
- |
|
Interest income |
|
23,302 |
|
|
|
6 |
|
Interest expense |
|
(606 |
) |
|
|
(959 |
) |
|
|
|
|
|
|
|
|
Comprehensive income
(loss) |
$ |
6,816,698 |
|
|
$ |
(737,892 |
) |
|
|
|
|
|
|
|
|
Per share information: |
|
|
|
|
|
|
|
Net income (loss) per share,
basic |
$ |
1.82 |
|
|
$ |
(0.24 |
) |
Net income (loss) per share,
diluted |
$ |
1.47 |
|
|
$ |
(0.24 |
) |
Weighted average common shares
outstanding, basic |
|
3,748,325 |
|
|
|
3,099,311 |
|
Weighted average common shares
outstanding, diluted |
|
4,625,295 |
|
|
|
3,099,311 |
|
|
|
|
|
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