PDS Biotechnology Corporation (Nasdaq: PDSB), a clinical-stage
immunotherapy company developing novel cancer therapies based on
the Company’s proprietary Versamune® T-cell activating technology,
will discuss its financial results for the quarter ended June 30,
2021 and provide a business update on its conference call today.
Recent Business Highlights:
- Presented interim
Phase 2 clinical data for lead product PDS0101, in an oral
presentation at the American Society for Clinical Oncology (ASCO)
2021 Annual Meeting. In the National Cancer Institute-led study,
tumor reduction was observed in 83% (5 of 6) of advanced
HPV16-positive cancer patients who had relapsed or failed treatment
with chemotherapy and radiation but had not been treated with
checkpoint inhibitor therapy. Tumor reduction was reported in 58%
(7 of 12) of HPV16-positive patients who in addition had also
failed checkpoint inhibitor therapy.
- Completed
approximately $52 Million public offering that will support next
phase of company growth through advancement of PDS0102 and PDS0103
into human clinical trials.
- Received $4.5
Million from the sale of Net Operating Loss tax benefits through
the New Jersey Economic Development Program.
- Appointed
immuno-oncology experts Dr. Olivera Finn and Dr. Mark Frohlich to
Scientific Advisory Board.
- Expanded
VERSATILE-002 study of PDS0101 and KEYTRUDA® in advanced head and
neck cancer to include patients who have failed prior treatment
with checkpoint inhibitors.
- Added to Russell
Microcap® Index as part of the 2021 annual reconstitution based on
market-capitalization rankings and style attributes.
“The second quarter has been quite significant for PDS Biotech
in providing the first demonstration of the clinical potential of
the Versamune®-based products in treating advanced,
treatment-resistant cancers. We believe the unprecedented objective
responses and tumor reduction observed in our most advanced PDS0101
phase 2 clinical trial demonstrate the potential of the Versamune®
platform to overcome one of the most significant limitations
preventing broadly effective cancer immunotherapy. Versamune® has
the potential to induce high levels of potent tumor-specific killer
T-cells that may attack and eliminate the cancer,” commented Dr.
Frank Bedu-Addo, President and Chief Executive Officer of PDS
Biotech. “Our capital raise of approximately $52M in June, further
strengthens our balance sheet and provides us with the capital
necessary to continue advancing our promising immuno-oncology
pipeline. Renowned experts in fields of prostate and MUC1
associated cancers joined our Scientific Advisory Board to
facilitate development of our pipeline products. The Company is
well positioned and now has the momentum to move quickly to the
next phase of growth by accelerating advancement of PDS0102 and
PDS0103 into clinical trials.”
Interim Study Results
in NCI-Led Phase 2 Clinical Study of
PDS0101 Highlight Potential of
Versamune®
In June, the Company reported interim Phase 2 clinical trial
data from one of three ongoing PDS0101 Phase 2 trials at the
American Society for Clinical Oncology (ASCO) 2021 Annual Meeting.
This Phase 2 trial is studying PDS0101 (Versamune®-HPV16) in
combination with two investigational immune-modulating agents:
Bintrafusp alfa (M7824), a bifunctional “trap” fusion protein
targeting TGF-β and PD-L1, and NHS-IL12 (M9241), a tumor-targeting
immunocytokine. PDS0101 is an investigational
immunotherapy designed to treat cancers caused by infection with
HPV16 (HPV16-positive cancers) by training and activating the
immune system to produce large numbers of in vivo CD8+ (killer)
T-cells to target and kill tumors that are
HPV16-positive.
Analysis of the interim clinical data showed that of the initial
six HPV16-positive patients who had not been treated with
checkpoint inhibitors, 83% (5 of 6) of the patients demonstrated an
objective response (tumor reduction >30%). One patient had
achieved a complete response. The reported objective response rate
with current standard of care checkpoint inhibitor treatment is
12-24%. It was also reported that 100% (6/6) of the patients were
still alive (median 8 months). The historical average (median)
survival or life span for this patient population is 7-11
months.
Of the twelve HPV16-positive patients who had also failed
treatment with checkpoint inhibitors after failing chemotherapy and
radiation treatment, tumor reduction was observed in 58% (7/12). An
objective response rate of 42% (5/12) and one complete response had
already been achieved at the time of reporting in June. The
objective response rate reported with the standard of care in this
population is 5-12%. It was also reported that 83% (10/12) were
still alive (median 8 months). The historical median survival or
life span for this patient population is only 3-4 months.
Second Quarter 2021 Financial Results
PDS Biotech reported a net loss of approximately $0.6 million,
or ($.03) per basic share and diluted share, for the three months
ended June 30, 2021 compared to a net loss of approximately $2.9
million, or ($0.19) per basic share and diluted share, for the
three months ended June 30, 2020. The lower net loss
reported for the three months ended June 2021 is primarily due to
$4.5 million received from the sale of our NJ tax benefits pursuant
to the New Jersey Technology Business Tax Certificate Transfer Net
Operating Loss program.
Research and development (R&D) expenses
increased 95% to approximately $2.8 million for the three months
ended June 30, 2021 from approximately $1.4 million for the three
months ended June 30, 2020. A significant portion of the increase
is attributable to clinical expenses related to VERSATILE-002 which
is enrolling and progressing according to schedule. Preliminary
data on the trial is expected as previously projected in Q4 2021 or
Q1 2022.
The increase of $1.3 million in 2021 was
primarily attributable to an increase of $0.2 million in personnel
costs, $1.0 in clinical studies and $0.1 million in
manufacturing.
General and administrative expenses increased to
$2.3 million for the three months ended June 30, 2021 from $1.5
million for the three months ended June 30, 2020. The increase of
$0.8 million is primarily attributable to an increase in personnel
costs of $0.6 million and an increase in professional services of
$0.2 million..
Total operating expenses increased 74% to approximately $5.1
million for the three months ended June 30, 2021 from approximately
$2.9 million for the three months ended June 30, 2020.
PDS Biotech’s cash balance as of June 30, 2021 was approximately
$74.7 million.
Conference Call and Webcast
The conference call is scheduled to begin at 8:00 am ET on
Thursday, August 12, 2021. Participants should dial 877-407-3088
(United States) or 201-389-0927 (International) and mention PDS
Biotechnology. A live webcast of the conference call will also be
available on the investor relations page of the Company's corporate
website at www.pdsbiotech.com.
After the live webcast, the event will be archived on 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 13721612.
About PDS Biotechnology
PDS Biotech is a clinical-stage immunotherapy company developing
a growing pipeline of cancer immunotherapies based on the Company’s
proprietary Versamune® T-cell activating technology platform. Our
Versamune®-based products have demonstrated the potential to
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. The company’s pipeline products
address various cancers including breast, colon, lung, prostate and
ovarian cancers. 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 & Co., PDS Biotech is
evaluating a combination of PDS0101 and KEYTRUDA® in a Phase 2
study in first-line treatment of recurrent or metastatic head and
neck cancer. PDS Biotech is also conducting two additional Phase 2
studies in advanced HPV-associated cancers and advanced localized
cervical cancer with the National Cancer Institute (NCI) and The
University of Texas MD Anderson Cancer Center, respectively.
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® 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; 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; 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
Rich CockrellCG CapitalPhone: +1 (404) 736-3838 Email:
rich@cg.capital
PDS BIOTECHNOLOGY CORPORATION AND
SUBSIDIARIESCondensed Consolidated Balance Sheets
|
|
June 30, 2021 |
|
December 31, 2020 |
ASSETS |
|
(unaudited) |
|
Current assets: |
|
|
|
Cash and cash equivalents |
|
$ |
74,749,201 |
|
$ |
28,839,565 |
Prepaid expenses and other |
|
2,185,189 |
|
1,497,665 |
Total current assets |
|
76,934,390 |
|
30,337,230 |
|
|
|
|
Property and equipment, net |
|
2,310 |
|
5,443 |
Operating lease right-to-use asset |
|
454,026 |
|
547,706 |
|
|
|
|
Total assets |
|
$ |
77,390,726 |
|
$ |
30,890,379 |
|
|
|
|
LIABILITIES AND STOCKHOLDERS' EQUITY |
|
|
|
Current liabilities: |
|
|
|
Accounts payable |
|
$ |
2,375,363 |
|
$ |
1,415,224 |
Accrued expenses |
|
1,469,792 |
|
1,735,322 |
Operating lease obligation - short term |
|
157,663 |
|
119,904 |
Total current liabilities |
|
4,002,818 |
|
3,270,450 |
|
|
|
|
Noncurrent liability: |
|
|
|
Operating lease obligation - long term |
|
395,314 |
|
490,353 |
|
|
|
|
Total liabilities |
|
$ |
4,398,132 |
|
$ |
3,760,803 |
|
|
|
|
STOCKHOLDERS' EQUITY |
|
|
|
Common stock, $0.00033 par value, 75,000,000 shares authorized at
June 30, 2021 and December 31, 2020, 28,417,909 shares and
22,261,619 shares issued and outstanding at June 30, 2021 and
December 31, 2020, respectively |
|
9,377 |
|
7,346 |
Additional paid-in capital |
|
120,405,851 |
|
70,907,315 |
Accumulated deficit |
|
(47,422,634) |
|
(43,785,085) |
Total stockholders' equity |
|
72,992,594 |
|
27,129,576 |
|
|
|
|
Total liabilities and stockholders' equity |
|
$ |
77,390,726 |
|
$ |
30,890,379 |
PDS BIOTECHNOLOGY CORPORATION AND
SUBSIDIARIESCondensed Consolidated Statements of
Operations and Comprehensive
Loss(Unaudited)
|
|
Three Months Ended June 30, |
|
Six Months Ended June 30, |
|
|
2021 |
|
2020 |
|
2021 |
|
2020 |
Operating expenses: |
|
|
|
|
|
|
|
|
Research and development expenses |
|
$ |
2,764,195 |
|
$ |
1,414,225 |
|
$ |
4,177,252 |
|
$ |
3,385,904 |
General and administrative expenses |
|
2,341,828 |
|
1,521,736 |
|
3,978,044 |
|
3,581,884 |
Total operating expenses |
|
5,106,023 |
|
2,935,961 |
|
8,155,296 |
|
6,967,788 |
|
|
|
|
|
|
|
|
|
Loss from operations |
|
(5,106,023) |
|
(2,935,961) |
|
(8,155,296) |
|
(6,967,788) |
|
|
|
|
|
|
|
|
|
Interest income |
|
604 |
|
6,617 |
|
1,259 |
|
53,036 |
|
|
|
|
|
|
|
|
|
Loss before income taxes |
|
(5,105,419) |
|
(2,929,344) |
|
(8,154,037) |
|
(6,914,752) |
Benefit for Income Taxes |
|
4,516,488 |
|
- |
|
4,516,488 |
|
- |
Net loss and comprehensive
loss |
|
(588,931) |
|
(2,929,344) |
|
(3,637,549) |
|
(6,914,752) |
|
|
|
|
|
|
|
|
|
Per share information: |
|
|
|
|
|
|
|
|
Net loss per share , basic and diluted |
|
$ |
(0.03) |
|
$ |
(0.19) |
|
$ |
(0.16) |
|
$ |
(0.54) |
|
|
|
|
|
|
|
|
|
Weighted average common shares outstanding, basic and diluted |
|
23,160,371 |
|
15,357,199 |
|
22,714,581 |
|
12,835,980 |
|
|
|
|
|
|
|
|
|
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