PDS Biotechnology Corporation (“PDS Biotechnology”) (Nasdaq: PDSB),
a clinical-stage immuno-oncology company developing multiple
therapies based on T-cell activating technology called Versamune®
today announced its financial results for the full year ended
December 31, 2019 and provided a business update.
Fourth Quarter 2019 and Recent Business
Highlights
- Reported promising Phase 1 clinical
outcome data of PDS0101 in patients with cervical intraepithelial
neoplasia (CIN) infected with multiple high-risk, cancer-causing
types of human papillomavirus (HPV). Study demonstrated robust
treatment-induced HPV16-specific killer T-cell (CD8+) responses as
well as clearance of the disease and regression of lesions in the
majority of evaluable patients;
- Announced clinical collaboration
with Merck to evaluate PDS0101 in combination with KEYTRUDA®
(pembrolizumab) in first line treatment of metastatic head and neck
cancer;
- Selected Dr. Jared Weiss as
Principal Investigator for Phase 2 Clinical Collaboration with
Merck and formed an Independent Data Monitoring Committee;
- Completed manufacturing of clinical
batches of HPV mix component of PDS0101 for upcoming Phase 2
combination trials with Merck and National Cancer Institute;
- Announced pre-clinical
collaboration with Farmacore Biotechnology for tuberculosis;
- Granted U.S. and European Patents
for Versamune® - GM-CSF Combination to Overcome Tumor Immune
Suppression and US composition of matter patent for Versamune;
- Appointed Kamil Ali-Jackson, Esq.
to the Board of Directors; and
- Successfully completed an
underwritten public offering of its common stock with net proceeds
of approximately $11.9 million after deducting underwriting
discounts and commissions, not including other offering expenses in
February 2020.
“We have made significant progress over the last
year as we transitioned to a public company, strengthened our
partnerships with leaders in immuno-oncology, such as Merck and
National Cancer Institute and reported encouraging human data from
our lead program, PDS0101,” commented Dr. Frank Bedu-Addo,
President and Chief Executive Officer of PDS Biotechnology. “As we
forge ahead in 2020, we look forward to leveraging the highly
encouraging Phase I human clinical outcome data, which demonstrated
complete lesion regression in 60% of evaluable patients with
cervical intraepithelial neoplasia (CIN) and human papillomavirus
(HPV) within 1-3 months of treatment. These results support our
combination approach in our upcoming clinical trials and provide
evidence that PDS0101 could be essential in expanding the clinical
efficacy of checkpoint inhibitors and improving clinical outcomes
for patients.”
“With a strengthened balance sheet, we look
forward to initiating three studies, including; a Phase 2
combination study to evaluate PDS0101 in combination with KEYTRUDA®
in the first line treatment of metastatic head and neck cancer, a
Phase 2 study to evaluate PDS0101 in combination with two promising
immune-modulating agents in advanced HPV-associated cancers with
the NCI and a Phase 2a study to evaluate the combination of PDS0101
and chemoradiation in patients with locally advanced cervical
cancer. We remain committed to developing our novel Versamune
platform in collaboration with our partners and would like to thank
our shareholders for their continued support,” concluded Dr.
Bedu-Addo.
Full Year 2019 Financial
Review
For the year ended December 31, 2019, the net
loss was approximately $6.9 million, or $1.44 per basic and diluted
share. This compares to a net loss of approximately $3.8 million,
or $1.15 per basic and diluted share for the year ended December
31, 2018.
For the year ended December 31, 2019, research
and development expenses increased approximately 634% to
approximately $6.1 million compared to approximately $0.8 million
in the prior year. The increase is primarily attributable to an
increase in external expenses for clinical studies, internal
R&D personnel costs, non-cash stock-based compensation and
departmental costs.
For the year ended December 31, 2019, general
and administrative expenses increased approximately 294% to
approximately $11.0 million compared to approximately $2.8 million
in the prior year. The increase was due to increases in
personnel costs, non-cash stock-based compensation, facilities
costs, D&O insurance costs, legal fees, professional fees and
other operating expenses.
For the year ended December 31, 2019, total
operating expenses increased approximately 477% to approximately
$21.0 million compared to approximately $3.6 million in the prior
year.
As of December 31, 2019, the Company’s cash
balance was approximately $12.2 million. This amount does not
include 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 full exercise of the underwriters’
overallotment option, which closed in February.
About PDS Biotechnology
PDS Biotech is a clinical-stage immuno-oncology
company developing multiple therapies based on the Company’s
proprietary Versamune® T-cell activating technology platform. The
Versamune® platform effectively delivers tumor-specific antigens
for in vivo uptake and processing, while also activating a critical
immunological pathway, the type 1 interferon pathway, thus
resulting in the production of potent tumor-specific killer
T-cells. Using Versamune®, PDS Biotech is engineering therapies
designed to better recognize cancer cells and break down their
defense systems to effectively attack and destroy tumors. PDS
Biotech’s pipeline combines the Versamune® technology with
tumor-specific antigens across several cancer types. 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, PDS Biotech is
advancing a combination of PDS0101 and KEYTRUDA® to a Phase 2 study
in first line treatment of recurrent or metastatic head and neck
cancer. In partnership with the National Cancer Institute (NCI),
PDS Biotech is also advancing a combination of PDS0101 and two
clinical stage immunotherapies to a Phase 2 study in advanced
HPV-associated cancers. A third phase 2 study is to be performed in
advanced localized cervical cancer combining PDS0101 with the
chemoradiotherapy, which is the standard of care.
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,” 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; potential adverse
reactions or changes to business relationships resulting from the
resignation of the Company’s Chief Financial Officer or the
Company’s ability to find a replacement Chief Financial Officer;
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 and PDS0102; 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 and
Subsidiaries
Consolidated Balance Sheets
|
December 31, 2019 |
|
December 31, 2018 |
ASSETS |
|
|
|
Current assets: |
|
|
|
Cash and cash equivalents |
$ |
12,161,739 |
|
|
$ |
103,695 |
|
Prepaid expenses and other |
|
2,308,462 |
|
|
|
18,428 |
|
Total current assets |
|
14,470,201 |
|
|
|
122,123 |
|
|
|
|
|
|
|
Property and equipment, net |
|
21,051 |
|
|
|
29,508 |
|
Other assets |
|
– |
|
|
|
12,800 |
|
|
|
|
|
|
|
Total assets |
$ |
14,491,252 |
|
|
$ |
164,431 |
|
|
|
|
|
|
|
LIABILITIES AND STOCKHOLDERS'
EQUITY |
|
|
|
|
|
LIABILITIES |
|
|
|
|
|
Current liabilities: |
|
|
|
|
|
Accounts payable |
$ |
1,197,720 |
|
|
$ |
1,307,529 |
|
Accrued expenses |
|
1,097,640 |
|
|
|
601,889 |
|
Restructuring reserve |
|
498,185 |
|
|
|
– |
|
Total current liabilities |
|
2,793,545 |
|
|
|
1,909,418 |
|
|
|
|
|
|
|
Noncurrent liability: |
|
|
|
|
|
Warranty liability |
|
– |
|
|
|
291,225 |
|
Convertible promissory notes payable |
|
– |
|
|
|
30,000 |
|
Total liabilities |
|
2,793,545 |
|
|
|
2,230,643 |
|
|
|
|
|
|
|
STOCKHOLDERS' EQUITY |
|
|
|
|
|
Common stock, $0.00033 par value, 75,000,000 shares authorized at
December 31, 2019 and December 31, 2018, 5,281,237
shares and 3,417,187 shares issued and outstanding at
December 31, 2019 and December 31, 2018,
respectively |
|
1,742 |
|
|
|
1,128 |
|
Additional paid-in capital |
|
40,633,670 |
|
|
|
19,871,759 |
|
Accumulated deficit |
|
(28,937,705 |
) |
|
|
(21,939,099 |
) |
Total stockholders' equity (deficit) |
|
11,697,707 |
|
|
|
(2,066,212 |
) |
|
|
|
|
|
|
Total liabilities and stockholders' equity (deficit) |
$ |
14,491,252 |
|
|
$ |
164,431 |
|
|
|
|
|
|
|
|
|
PDS BIOTECHNOLOGY CORPORATION and
Subsidiaries
Consolidated Statements of Operations and
Comprehensive Loss
|
Year Ended December 31, |
|
2019 |
|
2018 |
Operating expenses: |
|
|
|
Research and development expenses |
$ |
6,099,580 |
|
|
$ |
830,744 |
|
General and administrative expenses |
|
10,981,765 |
|
|
|
2,788,016 |
|
Impairment expense-IPRD |
|
2,974,000 |
|
|
|
– |
|
Lease termination costs |
|
979,273 |
|
|
|
– |
|
Depreciation and amortization |
|
– |
|
|
|
27,426 |
|
|
|
|
|
|
|
Total operating expenses |
|
21,034,618 |
|
|
|
3,646,186 |
|
|
|
|
|
|
|
Loss from operations |
|
(21,034,618 |
) |
|
|
(3,646,186 |
) |
|
|
|
|
|
|
Other income (expense): |
|
|
|
|
|
Gain on bargain purchase upon merger |
|
13,334,568 |
|
|
|
– |
|
Interest income |
|
353,490 |
|
|
|
– |
|
Interest expense |
|
(33,559 |
) |
|
|
(3,595 |
) |
Other |
|
– |
|
|
|
(900 |
) |
Loss on extinguishment of debt |
|
– |
|
|
|
(185,800 |
) |
|
|
|
|
|
|
Loss before income taxes |
|
(7,380,119 |
) |
|
|
(3,836,481 |
) |
Income taxes
(benefit) |
|
(381,513 |
) |
|
|
– |
|
Net loss and comprehensive
loss |
$ |
(6,998,606 |
) |
|
$ |
(3,836,481 |
) |
|
|
|
|
|
|
Net loss per share, basic and
diluted |
$ |
1.44 |
|
|
$ |
1.15 |
|
|
|
|
|
|
|
Weighted average common shares
outstanding basic and diluted |
|
4,868,079 |
|
|
|
3,337,351 |
|
|
|
|
|
|
|
|
|
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