PDS Biotechnology logo

PDSB - PDS Biotechnology News Story

$5.69 -0.0  -0.4%

Last Trade - 9:00pm

Sector
Healthcare
Size
Small Cap
Market Cap £119.8m
Enterprise Value £68.3m
Revenue £n/a
Position in Universe 4961st / 7405

PDS Biotechnology Reports Financial Results for the Third Quarter 2020 and Provides Business Update

Wed 11th November, 2020 9:05pm
For best results when printing this announcement, please click on link below:
http://newsfile.refinitiv.com/getnewsfile/v1/story?guid=urn:newsml:reuters.com:20201111:nGNX6ZqYPw


FLORHAM PARK, N.J., Nov. 11, 2020 (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, today
announced its financial results for the third quarter ended September 30, 2020
and provided a business update.

Third Quarter 2020 and Recent Business Highlights
* Successfully raised approximately $19 million via a public offering of
common stock.
* Initiated VERSATILE-002, a Phase 2 trial of PDS0101, our investigational
drug candidate,  in combination with standard of care KEYTRUDA(®) for
first-line treatment of patients with metastatic or recurrent HPV-positive
head and neck cancer.
* Initiated a Phase 2 study of PDS0101 in combination with standard of care
chemoradiotherapy at the MD Anderson Cancer Center for treatment of locally
advanced cervical cancer.
* Continued development of PDS0103 in partnership with the National Cancer
Institute.
* Advanced co-development program with Farmacore with plans to move the
PDS0203 COVID-19 vaccine into clinical development with the support of the
Brazilian government.
* Expanded Board of Directors with appointment of preeminent oncologist, Otis
Brawley, M.D.
“As a result of our team’s dedicated efforts during the third quarter and
our clinical partnerships with leading institutions in immuno-oncology, today
PDS0101 is being evaluated in three phase 2 clinical trials for multiple
HPV-associated cancers,” commented Dr. Frank Bedu-Addo, President and Chief
Executive Officer of PDS Biotechnology. “Furthermore, the successful equity
raise we completed in August strengthened our balance sheet, ensuring we can
continue to progress the clinical development of our oncology programs as well
as expand both our oncology and infectious disease programs despite the
challenges posed by the COVID-19 pandemic.”

Third Quarter 2020 Financial Review

For the third quarter of 2020, net loss was approximately $3.9 million, or
$0.23 per basic share and diluted share, compared to a net loss of
approximately $5.8 million, or $1.10 per basic share and diluted share for the
third quarter of 2019.

Research and development expenses totaled approximately $2.1 million for the
third quarter of 2020, compared to approximately $1.8 million for the same
period in 2019, an increase of 12%. The increase was primarily attributable to
an increase of $0.1 million in technical operations (manufacturing) and $0.3
million in clinical studies, offset by a decrease of $0.1 million in
professional fees and $0.1 million in regulatory expenses.

For the third quarter of 2020, general and administrative expenses were
approximately $1.8 million compared with approximately $3.0 million during the
third quarter of 2019, a decrease of 40%. The decrease was primarily
attributable to a decrease of $0.2 million in salary and benefits, $0.1
million in facilities and office expense, $0.3 million in insurance expense,
$0.6 million in professional fees, and $0.1 million in legal fees offset by an
increase of $0.1 million in licenses, taxes and fees.

Total operating expenses for the third quarter of 2020 were approximately $3.9
million, compared to total operating expenses of approximately $5.8 million
during the same period of 2019, a decrease of 33%.

As of September 30, 2020, the Company’s cash balance was approximately $33.5
million.

Conference Call and Webcast

The conference call is scheduled to begin at 8:00 am ET on Thursday, November
12, 2020. 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 13712632.

About PDS Biotechnology

PDS Biotech is a clinical-stage immunotherapy company with a growing pipeline
of cancer immunotherapies and infectious disease vaccines based on the
Company’s proprietary Versamune(®) T-cell activating technology platform.
Versamune(®) effectively delivers disease-specific antigens for in
vivo uptake and processing, while also activating the critical type 1
interferon immunological pathway, resulting in production of potent
disease-specific killer T-cells as well as neutralizing antibodies. PDS
Biotech has engineered multiple therapies, based on combinations of
Versamune(®) and disease-specific antigens, designed to train the immune
system to better recognize disease cells and effectively attack and destroy
them. To learn more, please visit www.pdsbiotech.com or follow us on Twitter
at @PDSBiotech.

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 its lead asset PDS0101 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 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 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 Biotechnology
Phone: +1 (908) 517-3613
Email: drandolph@pdsbiotech.com

Jacob Goldberger
CG Capital
Phone: +1 (404) 736-3841
Email: jacob@cg.capital



PDS BIOTECHNOLOGY CORPORATION AND SUBSIDIARIES

Condensed Consolidated Balance Sheets

                                                                                                                                                                                                                                      September 30, 2020               December 31, 2019            
 ASSETS                                                                                                                                                                                                                               (unaudited)                                                   
 Current assets:                                                                                                                                                                                                                                                                                    
 Cash and cash equivalents                                                                                                                                                                                                            $        33,468,935              $       12,161,739           
 Prepaid expenses and other                                                                                                                                                                                                                    373,395                         2,308,462            
 Total current assets                                                                                                                                                                                                                          33,842,330                      14,470,201           
                                                                                                                                                                                                                                                                                                    
 Property and equipment, net                                                                                                                                                                                                                   9,345                           21,051               
 Operating lease right-to-use asset                                                                                                                                                                                                            593,580                         –                    
                                                                                                                                                                                                                                                                                                    
 Total assets                                                                                                                                                                                                                         $        34,445,255              $       14,491,252           
                                                                                                                                                                                                                                                                                                    
 LIABILITIES AND STOCKHOLDERS' EQUITY                                                                                                                                                                                                                                                               
 LIABILITIES                                                                                                                                                                                                                                                                                        
 Current liabilities:                                                                                                                                                                                                                                                                               
 Accounts payable                                                                                                                                                                                                                     $        1,559,591               $       1,197,720            
 Accrued expenses                                                                                                                                                                                                                              1,222,773                       1,097,640            
 Restructuring reserve                                                                                                                                                                                                                         –                               498,185              
 Operating lease obligation - short term                                                                                                                                                                                                       116,240                         –                    
 Total current liabilities                                                                                                                                                                                                                     2,898,604                       2,793,545            
                                                                                                                                                                                                                                                                                                    
 Noncurrent liability:                                                                                                                                                                                                                                                                              
 Operating lease obligation - long term                                                                                                                                                                                                        521,692                         –                    
                                                                                                                                                                                                                                                                                                    
 STOCKHOLDERS' EQUITY                                                                                                                                                                                                                                                                               
 Common stock, $0.00033 par value, 75,000,000 shares authorized at September 30, 2020 and December 31, 2019, 22,261,619 shares and 5,281,237 shares issued and outstanding at September 30, 2020 and December 31, 2019, respectively           7,346                           1,742                
 Additional paid-in capital                                                                                                                                                                                                                    70,775,892                      40,633,670           
 Accumulated deficit                                                                                                                                                                                                                           (39,758,279  )                  (28,937,705  )       
 Total stockholders' equity                                                                                                                                                                                                                    31,024,959                      11,697,707           
                                                                                                                                                                                                                                                                                                    
 Total liabilities and stockholders' equity                                                                                                                                                                                           $        34,445,255              $       14,491,252           
                                                                                                                                                                                                                                                                                                    

PDS BIOTECHNOLOGY CORPORATION AND SUBSIDIARIES

Condensed Consolidated Statements of Operations and Comprehensive Loss

(Unaudited)

                                                                Three Months Ended September 30,                             Nine Months Ended September 30,                              
                                                                2020                             2019                        2020                              2019                       
 Operating expenses:                                                                                                                                                                      
 Research and development expenses                              $      2,060,815                 $      1,834,371            $      5,446,718                  $      4,751,308           
 General and administrative expenses                                   1,846,214                        3,068,581                   5,428,098                         9,358,429           
 Lease termination costs                                               –                                944,445                     –                                 944,445             
                                                                                                                                                                                          
 Total operating expenses                                              3,907,029                        5,847,397                   10,874,816                        15,054,182          
                                                                                                                                                                                          
 Loss from operations                                                  (3,907,029  )                    (5,847,397  )               (10,874,816  )                    (15,054,182  )      
                                                                                                                                                                                          
 Other income (expense):                                                                                                                                                                  
 Gain on bargain purchase upon merger                                  –                                –                           –                                 11,939,331          
 Interest income                                                       1,207                            95,787                      54,242                            294,694             
 Interest expense                                                      –                                –                           –                                 (606         )      
                                                                                                                                                                                          
 Net loss and comprehensive loss                                       (3,905,822  )                    (5,751,610  )               (10,820,574  )                    (2,820,763   )      
 Per share information:                                                                                                                                                                   
 Net loss per share, basic and diluted                          $      (0.23       )             $      (1.10       )        $      (0.73        )             $      (0.60        )      
                                                                                                                                                                                          
 Weighted average common shares outstanding, basic and diluted  $      17,169,257                $      5,246,829            $      14,892,764                 $      4,729,153           

(https://www.globenewswire.com/NewsRoom/AttachmentNg/e2e7d124-dbd4-4140-9cc5-449d3488a902)



GlobeNewswire, Inc. 2020
© Stockopedia 2022, Refinitiv, Share Data Services.
This site cannot substitute for professional investment advice or independent factual verification. To use it, you must accept our Terms of Use, Privacy and Disclaimer policies.