PDS Biotechnology Corporation (Nasdaq: PDSB) (PDS Biotech or the
Company), a clinical-stage immunotherapy company developing a
growing pipeline of targeted cancer immunotherapies and infectious
disease vaccines based on the Company’s proprietary T cell
activating platforms, will discuss its financial results for the
quarter ended June 30, 2023 and provide a business update on its
conference call today.
Recent Business
Highlights:PDS0101 Lead Drug
Candidate
- VERSATILE-003:
Submitted the final Phase 3 clinical protocol and supporting
Chemistry, Manufacturing and Controls (CMC) information to the U.S.
Food and Drug Administration (FDA) to enable initiation of the
VERSATILE-003 randomized, controlled multicenter study of PDS0101
in combination with Merck’s anti-PD-1 therapy, KEYTRUDA®
(pembrolizumab) in patients with human papillomavirus (HPV)
16-positive recurrent and/or metastatic head and neck cancer in the
fourth quarter 2023
- VERSATILE-002:
Phase 2 open-label, multicenter study of PDS0101 in combination
with KEYTRUDA® in patients with human papillomavirus (HPV)
16-positive recurrent and/or metastatic head and neck cancer
- Announced clinical immune response data to be presented at
upcoming European Society for Medical Oncology (ESMO) Congress 2023
- Biomarker data highlighting HPV16-specific killer and helper T
cell responses will be presented
- Presented interim data at the 2023 American Society of Clinical
Oncology (ASCO) annual meeting, demonstrating a 12-month overall
survival rate of 87%, with only 8% of patients experiencing Grade 3
treatment-related adverse events, and no reports of more severe
Grade 4 or 5 adverse events
- Achieved the efficacy threshold in Stage 2 of this clinical
trial for the naïve patient arm
- 14 patients in the immune checkpoint inhibitor (ICI) naïve arm
experienced either a complete response or partial response on two
consecutive scans 9-12 weeks apart, constituting a confirmed
objective response. This result suggests that PDS0101 has a
statistically significant additive effect over published results of
ICI monotherapy
- Completed enrollment in the ICI naïve arm and expect final data
readout in mid-2024
PDS0301 Antibody-Conjugated Interleukin
12 (IL-12)
- PDS0301 +
docetaxel: Phase 2, open label, single-arm trial of
PDS0301 in combination with docetaxel in metastatic castration
sensitive and castration resistant prostate cancer, led by the
National Cancer Institute (NCI)
- Announced selection of abstract for
oral presentation by the NCI at the upcoming Cytokines 2023 Annual
Meeting on October 15-18, 2023
- The Phase 2 clinical trial is
investigating the safety, immune responses, and clinical activity
of the combination in metastatic prostate cancer patients
- First clinical trial of an
immunocytokine with docetaxel in prostate cancer patients
Business Highlights
- PDS Biotech was added to the broad-market Russell 2000® and
Russell 3000® Indexes in June 2023
“We continue to make significant strides with
our lead candidate, PDS0101, specifically with the regulatory and
clinical activities necessary to initiate the VERSATILE-003 trial,
as well as with progression of the Phase 2 VERSATILE-002 clinical
trial,” stated Dr. Frank Bedu-Addo, CEO of PDS Biotech. “In the
second quarter, at ASCO 2023, we presented interim data from
VERSATILE-002 which revealed an impressive estimated 12-month
overall survival rate of 87% and a progression-free survival of
10.4 months, while maintaining a favorable safety profile when
PDS0101 is combined with KEYTRUDA®. The reported 12-month overall
survival rate for immune checkpoint inhibitors is 30-50%. These
encouraging findings fuel our enthusiasm as we prepare to initiate
the Phase 3 VERSATILE-003 clinical trial in which patient overall
survival will be the primary trial outcome in the fourth quarter of
2023.”
Dr. Bedu-Addo further commented, “In addition to
our enthusiasm for PDS0101, we are thrilled about the prospects of
PDS0301 which we believe may potentially overcome some of the key
safety and efficacy limitations of current cytokines. We are
excited about the NCI’s abstract acceptance at the upcoming
Cytokines 2023 annual meeting. We anticipate these results have the
potential to offer valuable insights into the use of PDS0301 in
conjunction with chemotherapy for various solid tumors, presenting
a promising avenue for future development and commercialization
possibilities.”
Second Quarter 2023 Financial
Results
Net loss for the three months ended June 30,
2023 was approximately $11.5 million, or ($0.37) per basic share
and diluted share, compared to a net loss of approximately $5.8
million, or ($0.20) per basic share and diluted share, for the
three months ended June 30, 2022. The higher net loss this quarter
was primarily due to costs incurred in connection with our research
and development programs.
Research and development expenses increased to
$8.0 million for the three months ended June 30, 2023 from $3.8
million for the three months ended June 30, 2022. The increase of
$4.2 million is primarily attributable to an increase of $1.4
million in clinical trials, $0.5 million in personnel costs,
including $0.2 million in non-cash stock-based compensation, and
$2.3 million in manufacturing expenses.
General and administrative expenses increased to
$4.7 million for the three months ended June 30, 2023 from $3.3
million for the three months ended June 30, 2022. The increase of
$1.4 million is primarily attributable to an increase of $0.5
million in personnel costs, including $0.4 million in non-cash
stock-based compensation and $0.9 million in professional fees.
Cash and cash equivalents as of June 30, 2023,
totaled approximately $60.6 million. Based on the company’s cash
resources, PDS Biotech believes this amount is sufficient to fund
operations and research and development programs for 12 months
following the filing of the Company’s June 2023 Quarterly Report on
Form 10-Q which will be filed as of the date of this press
release.
Conference Call and Webcast
The conference call is scheduled to begin at
8:00 AM EDT today, August 14, 2023. Participants should dial
877-407-3088 (United States) or 201-389-0927 (International) and
reference conference ID 13731437. To access the webcast, please use
the following link. The event will be archived in the investor
relations section of PDS Biotech’s website for six months.
About PDS Biotechnology PDS
Biotech is a clinical-stage immunotherapy company developing a
growing pipeline of targeted cancer and infectious disease
immunotherapies based on our proprietary Versamune®, Versamune®
plus PDS0301, and Infectimune® T cell-activating platforms. We
believe our targeted immunotherapies have the potential to overcome
the limitations of current immunotherapy approaches through the
activation of the right type, quantity and potency of T cells. To
date, our lead Versamune® clinical candidate, PDS0101, has
demonstrated the ability to reduce and shrink tumors and stabilize
disease in combination with approved and investigational
therapeutics in patients with a broad range of HPV16-associated
cancers in multiple Phase 2 clinical trials and will be advancing
into a Phase 3 clinical trial in combination with KEYTRUDA® for the
treatment of recurrent/metastatic HPV16-positive head and neck
cancer in 2023. Our Infectimune® based vaccines have also
demonstrated the potential to induce not only robust and durable
neutralizing antibody responses, but also powerful T cell
responses, including long-lasting memory T cell responses in
pre-clinical studies to date. To learn more, please visit
www.pdsbiotech.com or follow us on Twitter at @PDSBiotech.
About
Versamune®Versamune® is a novel
investigational T cell activating platform which effectively
stimulates a precise immune system response to a cancer-specific
protein. Versamune® based investigational immunotherapies promote a
potent targeted T cell attack against cancers expressing the
protein. They are given by subcutaneous injection and can be
combined with standard of care treatments. Clinical data suggest
that Versamune® based investigational immunotherapies, such as
PDS0101, demonstrate meaningful disease control by reducing and
shrinking tumors, delaying disease progression and/or prolonging
survival. Versamune® based immunotherapies have demonstrated
minimal toxicity to date that may allow them to be safely combined
with other treatments. We believe Versamune® based investigational
immunotherapies represent a transformative treatment approach for
cancer patients to provide improved efficacy, safety and
tolerability.
About PDS0101PDS0101, PDS
Biotech’s lead candidate, is a novel investigational human
papillomavirus (HPV)-targeted immunotherapy that stimulates a
potent targeted T cell attack against HPV-positive cancers. PDS0101
is given by subcutaneous injection alone or in combination with
other immunotherapies and cancer treatments. In a Phase 1 study of
PDS0101 in monotherapy, the treatment demonstrated the ability to
generate multifunctional HPV16 targeted CD8 and CD4 T cells with
minimal toxicity. Interim data suggests PDS0101 generates
clinically effective immune responses and the combination of
PDS0101 with other treatments can demonstrate significant disease
control by reducing or shrinking tumors, delaying disease
progression, and/or prolonging survival. The combination of PDS0101
with other treatments does not appear to compound the toxicity of
other agents.
About PDS0301PDS0301 is a novel
investigational tumor-targeting antibody-conjugated Interleukin 12
(IL-12) that enhances the proliferation, potency and longevity of T
cells in the tumor microenvironment. PDS0301 is given by a
subcutaneous injection. PDS0301 is designed to improve the safety
profile of IL-12 and to enhance the anti-tumor response.
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® and Infectimune® based product candidates; 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® and Infectimune® based product candidates 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 the Company’s ability to fully fund its disclosed
clinical trials, which assumes no material changes to the Company’s
currently projected expenses), futility analyses, presentations at
conferences and data reported in an abstract, and receipt of
interim or preliminary results (including, without limitation, any
preclinical results or data), 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; 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
other risks, uncertainties, and other factors described under “Risk
Factors,” “Management’s Discussion and Analysis of Financial
Condition and Results of Operations” and elsewhere in the documents
we file with the U.S. Securities and Exchange Commission. 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.
Versamune® and Infectimune® are registered
trademarks of PDS Biotechnology Corporation.
KEYTRUDA® is a registered trademark of Merck
Sharp and Dohme LLC, a subsidiary of Merck & Co., Inc., Rahway,
N.J., USA.
Investor Contacts: Deanne Randolph PDS Biotech
Phone: +1 (908) 517-3613 drandolph@pdsbiotech.com
Rich Cockrell CG Capital Phone: +1 (404) 736-3838
pdsb@cg.capital
Media Contacts: Tiberend Strategic Advisors,
Inc.Dave Schemelia Phone: +1 (609) 468-9325
dschemelia@tiberend.com
Eric ReissPhone: +1 (802) 249-1136ereiss@tiberend.com
PDS BIOTECHNOLOGY CORPORATION AND SUBSIDIARY |
Condensed Consolidated Balance Sheets |
|
|
June 30, 2023 |
|
December 31, 2022 |
ASSETS |
(unaudited) |
|
|
Current assets: |
|
|
|
Cash and cash equivalents |
$ |
60,624,991 |
|
|
$ |
73,820,160 |
|
Prepaid expenses and other assets |
|
2,725,958 |
|
|
|
2,660,230 |
|
Total current assets |
|
63,350,949 |
|
|
|
76,480,390 |
|
|
|
|
|
|
|
Property and equipment, net |
|
143,600 |
|
|
|
- |
|
Financing lease right-to-use assets |
|
220,213 |
|
|
|
374,888 |
|
Operating lease right-to-use asset |
|
39,488 |
|
|
|
152,645 |
|
|
|
|
|
|
|
Total assets |
$ |
63,754,250 |
|
|
$ |
77,007,923 |
|
|
|
|
|
|
|
LIABILITIES AND STOCKHOLDERS'
EQUITY |
|
|
|
|
|
Current liabilities: |
|
|
|
|
|
Accounts payable |
$ |
4,414,905 |
|
|
$ |
1,219,287 |
|
Accrued expenses |
|
3,376,325 |
|
|
|
8,313,708 |
|
Financing lease obligation-short term |
|
53,309 |
|
|
|
56,612 |
|
Operating lease obligation-short term |
|
59,650 |
|
|
|
231,429 |
|
Total current liabilities |
|
7,904,189 |
|
|
|
9,821,036 |
|
|
|
|
|
|
|
Noncurrent liabilities: |
|
|
|
|
|
Note payable, net of debt discount |
|
23,254,367 |
|
|
|
23,020,844 |
|
Financing lease obligation-long term |
|
151,505 |
|
|
|
164,013 |
|
Total liabilities: |
$ |
31,310,061 |
|
|
$ |
33,005,893 |
|
|
|
|
|
|
|
|
|
|
|
|
|
STOCKHOLDERS' EQUITY |
|
|
|
|
|
Common stock, $0.00033 par value, 75,000,000 shares authorized at
June 30, 2023and December 31, 2022, 30,868,188 shares and
30,170,317 shares issued andoutstanding at June 30, 2023 and
December 31, 2022, respectively |
|
10,188 |
|
|
|
9,956 |
|
Additional paid-in capital |
|
155,187,231 |
|
|
|
145,550,491 |
|
Accumulated deficit |
|
(122,753,230 |
) |
|
|
(101,558,417 |
) |
Total stockholders' equity |
|
32,444,189 |
|
|
|
44,002,030 |
|
|
|
|
|
|
|
Total liabilities and stockholders' equity |
$ |
63,754,250 |
|
|
$ |
77,007,923 |
|
|
PDS BIOTECHNOLOGY CORPORATION AND SUBSIDIARY |
Condensed Consolidated Statements of Operations and
Comprehensive Loss |
(Unaudited) |
|
|
Three Months Ended June 30, |
|
Six Months Ended June 30, |
|
|
2023 |
|
|
|
2022 |
|
|
|
2023 |
|
|
|
2022 |
|
Operating expenses: |
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
Research and development expenses |
$ |
8,004,852 |
|
|
$ |
3,761,646 |
|
|
$ |
13,848,538 |
|
|
$ |
8,922,961 |
|
General and administrative expenses |
|
4,691,321 |
|
|
|
3,331,006 |
|
|
|
8,270,049 |
|
|
|
6,648,913 |
|
Total operating expenses |
|
12,696,173 |
|
|
|
7,092,652 |
|
|
|
22,118,587 |
|
|
|
15,571,874 |
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
Loss from operations |
|
(12,696,173 |
) |
|
|
(7,092,652 |
) |
|
|
(22,118,587 |
) |
|
|
(15,571,874 |
) |
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
Interest income (expenses),
net |
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
Interest income |
|
750,654 |
|
|
|
74,547 |
|
|
|
1,479,995 |
|
|
|
80,247 |
|
Interest expense |
|
(995,397 |
) |
|
|
- |
|
|
|
(1,962,242 |
) |
|
|
- |
|
Interest income (expenses), net |
|
(244,743 |
) |
|
|
74,547 |
|
|
|
(482,247 |
) |
|
|
80,247 |
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
Loss before income taxes |
|
(12,940,916 |
) |
|
|
(7,018,105 |
) |
|
|
(22,600,834 |
) |
|
|
(15,491,627 |
) |
Benefit for income taxes |
|
1,406,021 |
|
|
|
1,198,905 |
|
|
|
1,406,021 |
|
|
|
1,198,905 |
|
Net loss and comprehensive
loss |
|
(11,534,895 |
) |
|
|
(5,819,200 |
) |
|
|
(21,194,813 |
) |
|
|
(14,292,722 |
) |
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
Per share information: |
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
Net loss per share, basic and
diluted |
$ |
(0.37 |
) |
|
$ |
(0.20 |
) |
|
$ |
(0.69 |
) |
|
$ |
(0.50 |
) |
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
Weighted average common shares
outstanding, basic,and diluted |
|
30,802,498 |
|
|
|
28,451,579 |
|
|
|
30,616,310 |
|
|
|
28,450,104 |
|
PDS Biotechnology (NASDAQ:PDSB)
過去 株価チャート
から 8 2024 まで 9 2024
PDS Biotechnology (NASDAQ:PDSB)
過去 株価チャート
から 9 2023 まで 9 2024