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PDSB - PDS Biotechnology News Story

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Market Cap £120.0m
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PDS Biotech Provides Business Update and Reports Third Quarter 2021 Financial Results

Wed 10th November, 2021 12:00pm
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FLORHAM PARK, N.J., Nov. 10, 2021 (GLOBE NEWSWIRE) -- 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, will
discuss its financial results for the quarter ended September 30, 2021 and
provide a business update on its conference call today.

Recent Business Highlights:
* Achieved several milestones in the VERSATILE-002 Phase 2 Combination Trial
of PDS0101-KEYTRUDA(®) for recurrent and/or metastatic human papillomavirus
(HPV)16-associated head and neck cancer. These milestones include:  *
Achievement of the preliminary safety benchmark for the first 12 patients
* Completion of enrollment for the first stage of the checkpoint inhibitor
naïve arm (1st line treatment of recurrent or metastatic head and neck
* Initiated enrollment of the second arm of the study addressing checkpoint
inhibitor refractory patients (2nd line treatment of recurrent or metastatic
head and neck cancer)
* Completed a licensing agreement with the National Cancer Institute (NCI) for
intellectual property related to the NCI’s proprietary T-cell receptor gamma
alternate reading frame protein (TARP) tumor antigen for use in PDS0102. *
PDS0102 is being developed to treat prostate cancer, breast cancer and acute
myeloid leukemia or AML.
* PDS0102 has demonstrated powerful induction of TARP-specific killer T-cells
in preclinical studies.
* Entered agreement to license COBRA (Computationally Optimized Broadly
Reactive Antigen) antigens from the University of Georgia for use in the
development of PDS0202, a novel Versamune(®)-based universal flu vaccine.
* Announced temporary administrative suspension of enrollment into the NCI-led
study of the PDS0101 triple combination. PDS Biotech continues to be in
contact with the NCI. Treatment of already enrolled patients has continued
without interruption.
* Announced the hiring of Matthew Hill as Chief Financial Officer, who has
more than 25 years of experience in finance and operational leadership roles
for life sciences companies.
“PDS Biotech has continued to build on its momentum from the interim data of
the last quarter in 2nd and 3rd line treatment of HPV16-positive anal,
cervical, head and neck, vaginal and vulvar cancers,” commented Dr. Frank
Bedu-Addo, President and Chief Executive Officer of PDS Biotech. “We have
achieved numerous clinical milestones, and formalized agreements with
development partners to continue to progress both our Versamune(®)-based
oncology pipeline and our Versamune(®)-based infectious diseases pipeline. We
also welcomed Matthew Hill as our new Chief Financial Officer. Matt has
decades of experience as a financial leader in publicly traded life sciences
companies and will be a key player in our next phase of growth. The groundwork
has been laid for the execution of multiple pipeline development milestones in
2022 and into 2023.”

Third Quarter 2021 Financial Results

PDS Biotech reported a net loss of approximately $7.0 million, or $(0.24) per
basic and diluted share, for the three months ended September 30, 2021,
compared to a net loss of approximately $3.9 million, or $(0.21) per basic and
diluted share, for the three months ended September 30, 2020.

Research and development expenses increased to approximately $3.7 million for
the three months ended September 30, 2021 from approximately $2.1 million for
the three months ended September 30, 2020. The increase of $1.6 million was
primarily attributable to an increase of $0.7 million in personnel costs of
which $0.5 million was stock compensation costs, and $0.9 million in costs
related to clinical studies.

General and administrative expenses increased to approximately $3.2 million
for the three months ended September 30, 2021 from approximately $1.8 million
for the three months ended September 30, 2020. The increase of $1.4 million is
primarily attributable to an increase in personnel costs of $1.6 million, of
which $1.0 million was stock compensation costs and $0.4 million was
severance, partially offset by a decrease in professional fees of $0.2

 PDS Biotech’s cash and cash equivalents as of September 30, 2021, were
approximately $69.7 million.

Conference Call and Webcast

The conference call is scheduled to begin at 8:00 am ET on Wednesday, November
10, 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 13722558.

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, and also in second line
treatment of recurrent or metastatic head and neck cancer in patients who have
failed prior checkpoint inhibitor therapy. PDS Biotech is also conducting a
Phase 2 clinical study in both second- and third-line treatment of multiple
advanced HPV-associated cancers with the National Cancer Institute (NCI). A
third phase 2 clinical trial in first line treatment of locally advanced
cervical cancer is being performed with The University of Texas, MD Anderson
Cancer Center.

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 or monitoring committees’
or other third parties’ 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, significance of
milestones, 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 Randolph
PDS Biotech
Phone: +1 (908) 517-3613
Email: drandolph@pdsbiotech.com

Rich Cockrell
CG Capital
Phone: +1 (404) 736-3838
Email: pdsb@cg.capital

Condensed Consolidated Balance Sheets

                                                                                                                                                                                                                                       September 30, 2021               December 31, 2020            
 ASSETS                                                                                                                                                                                                                                (unaudited)                                                   
 Current assets:                                                                                                                                                                                                                                                                                     
 Cash and cash equivalents                                                                                                                                                                                                             $        69,744,004              $       28,839,565           
 Prepaid expenses and other                                                                                                                                                                                                                     1,596,810                       1,497,665            
 Total current assets                                                                                                                                                                                                                           71,340,814                      30,337,230           
 Property and equipment, net                                                                                                                                                                                                                    1,037                           5,443                
 Operating lease right-to-use asset                                                                                                                                                                                                             406,171                         547,706              
 Total assets                                                                                                                                                                                                                          $        71,748,022              $       30,890,379           
 LIABILITIES AND STOCKHOLDERS’ EQUITY                                                                                                                                                                                                                                                                
 Current liabilities:                                                                                                                                                                                                                                                                                
 Accounts payable                                                                                                                                                                                                                      $        1,445,585               $       1,415,224            
 Accrued expenses                                                                                                                                                                                                                               1,923,846                       1,735,322            
 Operating lease obligation-short term                                                                                                                                                                                                          207,717                         119,904              
 Total current liabilities                                                                                                                                                                                                                      3,577,148                       3,270,450            
 Noncurrent liability:                                                                                                                                                                                                                                                                               
 Operating lease obligation-long term                                                                                                                                                                                                           313,976                         490,353              
 Total Liabilities                                                                                                                                                                                                                     $        3,891,124               $       3,760,803            
 STOCKHOLDERS’ EQUITY                                                                                                                                                                                                                                                                                
 Common stock, $0.00033 par value, 75,000,000 shares authorized at September 30, 2021 and December 31, 2020, 28,435,067 shares and 22,261,619 shares issued and outstanding at September 30, 2021 and December 31, 2020, respectively           9,383                           7,346                
 Additional paid-in capital                                                                                                                                                                                                                     122,231,115                     70,907,315           
 Accumulated deficit                                                                                                                                                                                                                            (54,383,600  )                  (43,785,085  )       
 Total stockholders’ equity                                                                                                                                                                                                                     67,856,898                      27,129,576           
 Total liabilities and stockholders’ equity                                                                                                                                                                                            $        71,748,022              $       30,890,379           

Condensed Consolidated Statements of Operations and Comprehensive Loss

                                                                Three Months Ended September 30,                             Nine Months Ended September 30,                              
                                                                2021                             2020                        2021                              2020                       
 Operating expenses:                                                                                                                                                                      
 Research and development expenses                              $      3,687,999                 $      2,060,815            $      7,865,249                  $      5,446,718           
 General and administrative expenses                                   3,274,325                        1,846,214                   7,252,371                         5,428,098           
 Total operating expenses                                              6,962,324                        3,907,029                   15,117,620                        10,874,816          
 Loss from operations                                                  (6,962,324  )                    (3,907,029  )               (15,117,620  )                    (10,874,816  )      
 Other income:                                                                                                                                                                            
 Interest income                                                       1,358                            1,207                       2,617                             54,242              
 Loss before income taxes                                              (6,960,966  )                    (3,905,822  )               (15,115,003  )                    (10,820,574  )      
 Benefit from income taxes                                             –                                –                           4,516,488                         –                   
 Net loss and comprehensive loss                                       (6,960,966  )                    (3,905,822  )               (10,598,515  )                    (10,820,574  )      
 Per share information:                                                                                                                                                                   
 Net loss per share, basic and diluted                          $      (0.24       )             $      (0.21       )        $      (0.43        )             $      (0.73        )      
 Weighted average common shares outstanding, basic and diluted         28,425,850                       18,961,619                  24,639,299                        14,892,764          


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