PDS Biotechnology Appoints Immuno-Oncology Experts Dr. Olivera Finn and Dr. Mark Frohlich to Scientific Advisory Board

 


PDS Biotechnology Appoints Immuno-Oncology Experts Dr. Olivera Finn and Dr. Mark Frohlich to Scientific Advisory Board

 

Preeminent translational cancer immunotherapy researcher and renowned clinical/commercial cancer immunotherapy expert join the advisory board

FLORHAM PARK, N.J., May 18, 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, today announced the appointment of Dr. Olivera Finn and Dr. Mark Frohlich to its Scientific Advisory Board.

Dr. Olivera Finn is a Distinguished Professor of Immunology at the University of Pittsburgh, School of Medicine. Dr. Finn brings over three decades of expertise in translational research in immunology and oncology, including the discovery of the first tumor-associated protein (antigen) recognized by T-cells, called MUC-1. In 2016, she received the National Cancer Institute’s Outstanding Investigator Award for her pioneering and extensive ground-breaking research in cancer immunotherapy. Previously, Dr. Finn served as the Director of the Cancer Immunology Program at the University of Pittsburgh Cancer Institute and is a Distinguished Fellow of the American Association of Immunologists. Dr. Finn obtained a Ph.D. in Immunology, and subsequently completed her postdoctoral fellowship at Stanford University.

Dr. Mark Frohlich is a renowned medical oncologist and biopharma executive who brings over 20 years of experience in developing immunotherapies for cancer. Dr. Frohlich has extensive clinical drug development and translational research expertise. As the Chief Medical Officer and Executive VP of R&D at Dendreon Corporation, he led the clinical team responsible for the development and approval of Provenge® for the treatment of advanced prostate cancer. Provenge® was the first therapeutic cancer vaccine to gain FDA approval. He subsequently served as Executive VP of Portfolio Strategy at Juno Therapeutics. Dr. Frohlich received his Doctor of Medicine degree from Harvard Medical School and completed his internal medicine residency and oncology fellowship at University of California San Francisco.

“We are excited to add Dr. Olivera Finn, Ph.D. and Dr. Mark Frohlich, M.D., two world-renowned immunotherapy experts, to our Scientific Advisory Board,” commented Dr. Lauren V. Wood, M.D., Chief Medical Officer of PDS Biotech. “These appointments further strengthen our translational research expertise in immuno-oncology as we prepare to progress clinical development of PDS0102 and PDS0103 for prostate and MUC-1 associated cancers respectively, and continue to advance our lead cancer immunotherapy PDS0101 through Phase 2 clinical testing. We very much look forward to adding their experience and guidance to our team of accomplished advisors.”

About PDS Biotechnology

PDS Biotech is a clinical-stage immunotherapy company developing a growing pipeline of cancer immunotherapies and infectious disease vaccines based on the Company’s proprietary Versamune® T-cell activating technology platform. Our Versamune®-based products 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. Our immuno-oncology product candidates are initially being studied in combination therapy to potentially enhance efficacy without compounding toxicity across a range of cancer types. The company’s lead investigational cancer immunotherapy product PDS0101 is currently in Phase 2 clinical studies in HPV-associated cancers. PDS Biotech is also collaborating with the National Cancer Institute to develop PDS0102 for prostate and breast cancers and to develop PDS0103, a MUC-1 targeting immunotherapy for breast, colon, lung and ovarian cancers. 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. 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 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; 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: rich@cg.capital

Onconova Therapeutics Reports First Quarter 2021 Financial Results And Provides Business Update


Onconova Therapeutics Reports First Quarter 2021 Financial Results And Provides Business Update

 

NEWTOWN, Pa., May 17, 2021 (GLOBE NEWSWIRE) — Onconova Therapeutics, Inc. (NASDAQ: ONTX) (“Onconova”), a clinical-stage biopharmaceutical company focused on discovering and developing novel products for patients with cancer, today announced financial results for the three months ended March 31, 2021 and provided a business update.

Highlights for the first quarter of 2021 and subsequent weeks include:

  • The Phase 1 solid tumor study with ON 123300 in China is ongoing with no dose-limiting toxicities observed in the first two cohorts. Enrollment to the third cohort (120 mg) will now proceed.
  • The Phase 1 study with ON 123300 in the United States is open for enrollment, and actively screening patients.
  • The first patient has been dosed in an investigator-initiated Phase 2 study designed to assess the efficacy and safety of rigosertib in patients with recessive dystrophic epidermolysis bullosa (RDEB)-associated locally advanced/metastatic squamous cell carcinoma (SCC).
  • The investigator-initiated Phase 1/2 study evaluating rigosertib in combination with the checkpoint inhibitor nivolumab in KRAS mutated non-small cell lung cancer has progressed nicely and has reached the maximum dose of oral rigosertib per the current protocol.
  • The Company strengthened its balance sheet with net proceeds of $35.2 million from two equity offerings; cash and cash equivalents as of March 31, 2021 were $48.0 million. The Company believes it has more than 18 months of cash runway.

Management Commentary

“We are off to a strong start in 2021 and remain focused on advancing our clinical programs, in particular with our lead product candidate ON 123300, a multi-kinase inhibitor that potently targets CDK 4 and 6, which are overexpressed in a number of cancers, including HR+ HER 2- metastatic breast cancer, a potential blockbuster commercial opportunity,” said Steven M. Fruchtman, M.D., President and Chief Executive Officer of Onconova. “We are delighted that our partner in China, HanX Biopharmaceuticals, is expected to begin the third cohort of their Phase 1 study at 120 mg per dose and that ON 123300 appears to be well tolerated with no dose-limiting toxicities observed to date. Notably, the HanX study is dosing patients on days 1 to 21 of 28-day cycles, while the U.S. Phase 1 study will be investigating a continuous daily dosing regimen. Collectively, we expect these complementary studies to generate important safety data that will inform the design of subsequent trials and potentially provide preliminary signals of efficacy in patients with advanced cancer.”

Dr. Fruchtman continued, “Alongside the progress made with our lead product candidate, we have also seen advancements in several investigator-initiated trials evaluating rigosertib. The first patient was recently dosed in a Phase 2 trial evaluating rigosertib monotherapy in advanced squamous cell carcinoma associated with recessive dystrophic epidermolysis bullosa, a disease with a critical unmet medical need. Additionally, the Phase 1/2 study evaluating rigosertib in combination with the checkpoint inhibitor nivolumab in KRAS mutated non-small cell lung cancer continues to progress and has reached the highest dose per the current protocol. We expect to continue leveraging our relationships with leading cancer centers and industry collaborators to advance these trials and commence additional investigator initiated studies in RAS-driven cancers in combination with checkpoint inhibitors. We expect such an approach to facilitate our near- and long-term growth by allowing us to preserve our primary focus and resources on ON 123300 while simultaneously pursuing opportunities to develop rigosertib in high unmet need indications.”

First Quarter Financial Results

Cash and cash equivalents as of March 31, 2021 were $48.0 million, compared with $19.0 million as of December 31, 2020. The Company believes that its cash and cash equivalents will be sufficient to fund ongoing clinical trials and business operations for more than 18 months.

Research and development expenses were $1.9 million for the first quarter of 2021, compared with $3.4 million for the first quarter of 2020. The decrease was primarily related to lower expenses for the oral rigosertib combination program and the completed Phase 3 INSPIRE study in the 2021 period.

General and administrative expenses were $2.2 million for the first quarter of 2021, compared with $1.8 million for the first quarter of 2020. The increase was primarily related to higher special stockholder meeting by proxy expenses and insurance costs in the 2021 period.

Net loss for the first quarter of 2021 was $4.7 million, or $0.02 per share on 219.2 million weighted average shares outstanding, compared with a net loss for the first quarter of 2020 of $5.1 million, or $0.03 per share on 160.3 million weighted average shares outstanding.

Conference Call and Webcast

A live webcast of the conference call will be available in the Investors & Media section of the Company’s website at www.onconova.com. A replay of the webcast will be available on the Onconova website for 90 days following the call.

About Onconova Therapeutics, Inc.
Onconova Therapeutics is a clinical-stage biopharmaceutical company focused on discovering and developing novel products for patients with cancer. The Company has proprietary targeted anti-cancer agents designed to disrupt specific cellular pathways that are important for cancer cell proliferation.

Onconova’s novel, proprietary multi-kinase inhibitor ON 123300 is planned to begin a dose-escalation and expansion Phase 1 trial in the U.S. in 2Q21, and a dose-escalation and expansion Phase 1 trial is currently underway in China.

Onconova’s product candidate rigosertib is being studied in an investigator-initiated study program, including in a dose-escalation and expansion Phase 1 investigator-initiated study targeting patients with KRAS+ non-small cell lung cancer with oral rigosertib in combination with nivolumab. In addition, Onconova continues to conduct preclinical work investigating rigosertib in COVID-19.

For more information, please visit www.onconova.com.

Forward-Looking Statements
Some of the statements in this release are forward-looking statements within the meaning of Section 27A of the Securities Act of 1933, as amended, Section 21E of the Securities Exchange Act of 1934, as amended, and the Private Securities Litigation Reform Act of 1995, and involve risks and uncertainties. These statements relate to Onconova’s expectations regarding the registered direct offering, its patents and clinical development plans including patient enrollment timelines and indications for its product candidates. Onconova has attempted to identify forward-looking statements by terminology including “believes,” “estimates,” “anticipates,” “expects,” “plans,” “intends,” “may,” “could,” “might,” “will,” “should,” “approximately” or other words that convey uncertainty of future events or outcomes. Although Onconova believes that the expectations reflected in such forward-looking statements are reasonable as of the date made, expectations may prove to have been materially different from the results expressed or implied by such forward-looking statements. These statements are only predictions and involve known and unknown risks, uncertainties, and other factors, including the success and timing of Onconova’s clinical trials and regulatory agency and institutional review board approvals of protocols, Onconova’s ability to continue as a going concern, the need for additional financing, Onconova’s collaborations, market conditions and those discussed under the heading “Risk Factors” in Onconova’s most recent Annual Report on Form 10-K and quarterly reports on Form 10-Q. Any forward-looking statements contained in this release speak only as of its date. Onconova undertakes no obligation to update any forward-looking statements contained in this release to reflect events or circumstances occurring after its date or to reflect the occurrence of unanticipated events.

Company Contact:
Avi Oler
Onconova Therapeutics, Inc.
267-759-3680
ir@onconova.us
https://www.onconova.com/contact/

Investor Contact:
Bruce Mackle
LifeSci Advisors, LLC
(929) 469-3859
bmackle@lifesciadvisors.com

(Tables to follow)

    
ONCONOVA THERAPEUTICS, INC.   
Condensed Consolidated Balance Sheets   
(in thousands)   
       
  March 31,   December 31,
   2021    2020
Assets (unaudited)    
Current assets:      
Cash and cash equivalents $ 48,005     $ 19,025  
Receivables   38       37  
Prepaid expenses and other current assets   607       722  
Total current assets   48,650       19,784  
Property and equipment, net   49       52  
Other non-current assets   150       150  
Total assets $ 48,849     $ 19,986  
       
Liabilities and stockholders’ equity      
Current liabilities:      
Accounts payable $ 3,988     $ 4,833  
Accrued expenses and other current liabilities   3,112       4,962  
Deferred revenue   226       226  
Total current liabilities   7,326       10,021  
Warrant liability   957       321  
Deferred revenue, non-current   3,413       3,469  
Total liabilities   11,696       13,811  
       
Stockholders’ equity:      
Preferred stock          
Common stock   2,367       1,859  
Additional paid in capital   468,059       432,858  
Accumulated other comprehensive (loss) income   (2 )     14  
Accumulated deficit   (433,271 )     (428,556 )
Total stockholders’ equity   37,153       6,175  
Total liabilities and stockholders’ equity $ 48,849     $ 19,986  
       


    
ONCONOVA THERAPEUTICS, INC.
Condensed Consolidated Statements of Operations (unaudited)
(in thousands, except share and per share amounts)
       
  Three months ended March 31,
   2021    2020
       
Revenue $ 56     $ 52  
Operating expenses:      
General and administrative   2,217       1,807  
Research and development   1,937       3,370  
Total operating expenses   4,154       5,177  
Loss from operations   (4,098 )     (5,125 )
       
Change in fair value of warrant liability   (636 )     (63 )
Other income, net   19       96  
Net loss   (4,715 )     (5,092 )
       
Net loss per share of common stock, basic and diluted $ (0.02 )   $ (0.03 )
Basic and diluted weighted average shares outstanding   219,242,077       160,346,087  
       

Helius Medical Technologies (HSDT)(HSM:CA) – First Quarter Results; Moving Forward with U.S. Commercialization

Tuesday, May 18, 2021

Helius Medical Technologies (HSDT)(HSM:CA)
First Quarter Results; Moving Forward with U.S. Commercialization

Helius Medical Technologies is a neurotech company focused on neurological wellness. The Company’s purpose is to develop, license and acquire unique and non-invasive platform technologies that amplify the brain’s ability to heal itself. The Company’s first commercial product is the Portable Neuromodulation Stimulator (PoNSTM). For more information, visit www.heliusmedical.com.

Joe Gomes, Senior Research Analyst, Noble Capital Markets, Inc.

Refer to the full report for the price target, fundamental analysis, and rating.

    1Q21 Results. Helius reported first quarter 2021 revenue of $84,000, down from $207,000 in the same period last year. Net loss for the quarter was $3.4 million, or $1.65 per share, compared to a net loss of $4.8 million, or $5.38 per share in the first quarter last year. We had forecast revenue of $87,000 and a net loss of $2.8 million, or $1.22 per share.

    U.S.  Commercialization. Following FDA approval in March, Helius is developing a plan for U.S. commercialization of the PoNS Treatment. The Company is well on it way of obtaining state approvals, currently approved in 24 states. A team is being assembled to develop and implement a “go to market strategy.” Helius will initially focus on early adopters in the neurologist community and …



This Company Sponsored Research is provided by Noble Capital Markets, Inc., a FINRA and S.E.C. registered broker-dealer (B/D).

*Analyst certification and important disclosures included in the full report. NOTE: investment decisions should not be based upon the content of this research summary.  Proper due diligence is required before making any investment decision. 

Helius Medical Technologies (HSDT)(HSM:CA) – First Quarter Results Moving Forward with U.S. Commercialization

Tuesday, May 18, 2021

Helius Medical Technologies (HSDT)(HSM:CA)
First Quarter Results; Moving Forward with U.S. Commercialization

Helius Medical Technologies is a neurotech company focused on neurological wellness. The Company’s purpose is to develop, license and acquire unique and non-invasive platform technologies that amplify the brain’s ability to heal itself. The Company’s first commercial product is the Portable Neuromodulation Stimulator (PoNSTM). For more information, visit www.heliusmedical.com.

Joe Gomes, Senior Research Analyst, Noble Capital Markets, Inc.

Refer to the full report for the price target, fundamental analysis, and rating.

    1Q21 Results. Helius reported first quarter 2021 revenue of $84,000, down from $207,000 in the same period last year. Net loss for the quarter was $3.4 million, or $1.65 per share, compared to a net loss of $4.8 million, or $5.38 per share in the first quarter last year. We had forecast revenue of $87,000 and a net loss of $2.8 million, or $1.22 per share.

    U.S.  Commercialization. Following FDA approval in March, Helius is developing a plan for U.S. commercialization of the PoNS Treatment. The Company is well on it way of obtaining state approvals, currently approved in 24 states. A team is being assembled to develop and implement a “go to market strategy.” Helius will initially focus on early adopters in the neurologist community and …



This Company Sponsored Research is provided by Noble Capital Markets, Inc., a FINRA and S.E.C. registered broker-dealer (B/D).

*Analyst certification and important disclosures included in the full report. NOTE: investment decisions should not be based upon the content of this research summary.  Proper due diligence is required before making any investment decision. 

Release – Onconova Therapeutics Reports First Quarter 2021 Financial Results And Provides Business Update


Onconova Therapeutics Reports First Quarter 2021 Financial Results And Provides Business Update

 

NEWTOWN, Pa., May 17, 2021 (GLOBE NEWSWIRE) — Onconova Therapeutics, Inc. (NASDAQ: ONTX) (“Onconova”), a clinical-stage biopharmaceutical company focused on discovering and developing novel products for patients with cancer, today announced financial results for the three months ended March 31, 2021 and provided a business update.

Highlights for the first quarter of 2021 and subsequent weeks include:

  • The Phase 1 solid tumor study with ON 123300 in China is ongoing with no dose-limiting toxicities observed in the first two cohorts. Enrollment to the third cohort (120 mg) will now proceed.
  • The Phase 1 study with ON 123300 in the United States is open for enrollment, and actively screening patients.
  • The first patient has been dosed in an investigator-initiated Phase 2 study designed to assess the efficacy and safety of rigosertib in patients with recessive dystrophic epidermolysis bullosa (RDEB)-associated locally advanced/metastatic squamous cell carcinoma (SCC).
  • The investigator-initiated Phase 1/2 study evaluating rigosertib in combination with the checkpoint inhibitor nivolumab in KRAS mutated non-small cell lung cancer has progressed nicely and has reached the maximum dose of oral rigosertib per the current protocol.
  • The Company strengthened its balance sheet with net proceeds of $35.2 million from two equity offerings; cash and cash equivalents as of March 31, 2021 were $48.0 million. The Company believes it has more than 18 months of cash runway.

Management Commentary

“We are off to a strong start in 2021 and remain focused on advancing our clinical programs, in particular with our lead product candidate ON 123300, a multi-kinase inhibitor that potently targets CDK 4 and 6, which are overexpressed in a number of cancers, including HR+ HER 2- metastatic breast cancer, a potential blockbuster commercial opportunity,” said Steven M. Fruchtman, M.D., President and Chief Executive Officer of Onconova. “We are delighted that our partner in China, HanX Biopharmaceuticals, is expected to begin the third cohort of their Phase 1 study at 120 mg per dose and that ON 123300 appears to be well tolerated with no dose-limiting toxicities observed to date. Notably, the HanX study is dosing patients on days 1 to 21 of 28-day cycles, while the U.S. Phase 1 study will be investigating a continuous daily dosing regimen. Collectively, we expect these complementary studies to generate important safety data that will inform the design of subsequent trials and potentially provide preliminary signals of efficacy in patients with advanced cancer.”

Dr. Fruchtman continued, “Alongside the progress made with our lead product candidate, we have also seen advancements in several investigator-initiated trials evaluating rigosertib. The first patient was recently dosed in a Phase 2 trial evaluating rigosertib monotherapy in advanced squamous cell carcinoma associated with recessive dystrophic epidermolysis bullosa, a disease with a critical unmet medical need. Additionally, the Phase 1/2 study evaluating rigosertib in combination with the checkpoint inhibitor nivolumab in KRAS mutated non-small cell lung cancer continues to progress and has reached the highest dose per the current protocol. We expect to continue leveraging our relationships with leading cancer centers and industry collaborators to advance these trials and commence additional investigator initiated studies in RAS-driven cancers in combination with checkpoint inhibitors. We expect such an approach to facilitate our near- and long-term growth by allowing us to preserve our primary focus and resources on ON 123300 while simultaneously pursuing opportunities to develop rigosertib in high unmet need indications.”

First Quarter Financial Results

Cash and cash equivalents as of March 31, 2021 were $48.0 million, compared with $19.0 million as of December 31, 2020. The Company believes that its cash and cash equivalents will be sufficient to fund ongoing clinical trials and business operations for more than 18 months.

Research and development expenses were $1.9 million for the first quarter of 2021, compared with $3.4 million for the first quarter of 2020. The decrease was primarily related to lower expenses for the oral rigosertib combination program and the completed Phase 3 INSPIRE study in the 2021 period.

General and administrative expenses were $2.2 million for the first quarter of 2021, compared with $1.8 million for the first quarter of 2020. The increase was primarily related to higher special stockholder meeting by proxy expenses and insurance costs in the 2021 period.

Net loss for the first quarter of 2021 was $4.7 million, or $0.02 per share on 219.2 million weighted average shares outstanding, compared with a net loss for the first quarter of 2020 of $5.1 million, or $0.03 per share on 160.3 million weighted average shares outstanding.

Conference Call and Webcast

A live webcast of the conference call will be available in the Investors & Media section of the Company’s website at www.onconova.com. A replay of the webcast will be available on the Onconova website for 90 days following the call.

About Onconova Therapeutics, Inc.
Onconova Therapeutics is a clinical-stage biopharmaceutical company focused on discovering and developing novel products for patients with cancer. The Company has proprietary targeted anti-cancer agents designed to disrupt specific cellular pathways that are important for cancer cell proliferation.

Onconova’s novel, proprietary multi-kinase inhibitor ON 123300 is planned to begin a dose-escalation and expansion Phase 1 trial in the U.S. in 2Q21, and a dose-escalation and expansion Phase 1 trial is currently underway in China.

Onconova’s product candidate rigosertib is being studied in an investigator-initiated study program, including in a dose-escalation and expansion Phase 1 investigator-initiated study targeting patients with KRAS+ non-small cell lung cancer with oral rigosertib in combination with nivolumab. In addition, Onconova continues to conduct preclinical work investigating rigosertib in COVID-19.

For more information, please visit www.onconova.com.

Forward-Looking Statements
Some of the statements in this release are forward-looking statements within the meaning of Section 27A of the Securities Act of 1933, as amended, Section 21E of the Securities Exchange Act of 1934, as amended, and the Private Securities Litigation Reform Act of 1995, and involve risks and uncertainties. These statements relate to Onconova’s expectations regarding the registered direct offering, its patents and clinical development plans including patient enrollment timelines and indications for its product candidates. Onconova has attempted to identify forward-looking statements by terminology including “believes,” “estimates,” “anticipates,” “expects,” “plans,” “intends,” “may,” “could,” “might,” “will,” “should,” “approximately” or other words that convey uncertainty of future events or outcomes. Although Onconova believes that the expectations reflected in such forward-looking statements are reasonable as of the date made, expectations may prove to have been materially different from the results expressed or implied by such forward-looking statements. These statements are only predictions and involve known and unknown risks, uncertainties, and other factors, including the success and timing of Onconova’s clinical trials and regulatory agency and institutional review board approvals of protocols, Onconova’s ability to continue as a going concern, the need for additional financing, Onconova’s collaborations, market conditions and those discussed under the heading “Risk Factors” in Onconova’s most recent Annual Report on Form 10-K and quarterly reports on Form 10-Q. Any forward-looking statements contained in this release speak only as of its date. Onconova undertakes no obligation to update any forward-looking statements contained in this release to reflect events or circumstances occurring after its date or to reflect the occurrence of unanticipated events.

Company Contact:
Avi Oler
Onconova Therapeutics, Inc.
267-759-3680
ir@onconova.us
https://www.onconova.com/contact/

Investor Contact:
Bruce Mackle
LifeSci Advisors, LLC
(929) 469-3859
bmackle@lifesciadvisors.com

(Tables to follow)

    
ONCONOVA THERAPEUTICS, INC.   
Condensed Consolidated Balance Sheets   
(in thousands)   
       
  March 31,   December 31,
   2021    2020
Assets (unaudited)    
Current assets:      
Cash and cash equivalents $ 48,005     $ 19,025  
Receivables   38       37  
Prepaid expenses and other current assets   607       722  
Total current assets   48,650       19,784  
Property and equipment, net   49       52  
Other non-current assets   150       150  
Total assets $ 48,849     $ 19,986  
       
Liabilities and stockholders’ equity      
Current liabilities:      
Accounts payable $ 3,988     $ 4,833  
Accrued expenses and other current liabilities   3,112       4,962  
Deferred revenue   226       226  
Total current liabilities   7,326       10,021  
Warrant liability   957       321  
Deferred revenue, non-current   3,413       3,469  
Total liabilities   11,696       13,811  
       
Stockholders’ equity:      
Preferred stock          
Common stock   2,367       1,859  
Additional paid in capital   468,059       432,858  
Accumulated other comprehensive (loss) income   (2 )     14  
Accumulated deficit   (433,271 )     (428,556 )
Total stockholders’ equity   37,153       6,175  
Total liabilities and stockholders’ equity $ 48,849     $ 19,986  
       


    
ONCONOVA THERAPEUTICS, INC.
Condensed Consolidated Statements of Operations (unaudited)
(in thousands, except share and per share amounts)
       
  Three months ended March 31,
   2021    2020
       
Revenue $ 56     $ 52  
Operating expenses:      
General and administrative   2,217       1,807  
Research and development   1,937       3,370  
Total operating expenses   4,154       5,177  
Loss from operations   (4,098 )     (5,125 )
       
Change in fair value of warrant liability   (636 )     (63 )
Other income, net   19       96  
Net loss   (4,715 )     (5,092 )
       
Net loss per share of common stock, basic and diluted $ (0.02 )   $ (0.03 )
Basic and diluted weighted average shares outstanding   219,242,077       160,346,087  
       

Release – PDS Biotechnology Appoints Immuno-Oncology Experts Dr. Olivera Finn and Dr. Mark Frohlich to Scientific Advisory Board

 


PDS Biotechnology Appoints Immuno-Oncology Experts Dr. Olivera Finn and Dr. Mark Frohlich to Scientific Advisory Board

 

Preeminent translational cancer immunotherapy researcher and renowned clinical/commercial cancer immunotherapy expert join the advisory board

FLORHAM PARK, N.J., May 18, 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, today announced the appointment of Dr. Olivera Finn and Dr. Mark Frohlich to its Scientific Advisory Board.

Dr. Olivera Finn is a Distinguished Professor of Immunology at the University of Pittsburgh, School of Medicine. Dr. Finn brings over three decades of expertise in translational research in immunology and oncology, including the discovery of the first tumor-associated protein (antigen) recognized by T-cells, called MUC-1. In 2016, she received the National Cancer Institute’s Outstanding Investigator Award for her pioneering and extensive ground-breaking research in cancer immunotherapy. Previously, Dr. Finn served as the Director of the Cancer Immunology Program at the University of Pittsburgh Cancer Institute and is a Distinguished Fellow of the American Association of Immunologists. Dr. Finn obtained a Ph.D. in Immunology, and subsequently completed her postdoctoral fellowship at Stanford University.

Dr. Mark Frohlich is a renowned medical oncologist and biopharma executive who brings over 20 years of experience in developing immunotherapies for cancer. Dr. Frohlich has extensive clinical drug development and translational research expertise. As the Chief Medical Officer and Executive VP of R&D at Dendreon Corporation, he led the clinical team responsible for the development and approval of Provenge® for the treatment of advanced prostate cancer. Provenge® was the first therapeutic cancer vaccine to gain FDA approval. He subsequently served as Executive VP of Portfolio Strategy at Juno Therapeutics. Dr. Frohlich received his Doctor of Medicine degree from Harvard Medical School and completed his internal medicine residency and oncology fellowship at University of California San Francisco.

“We are excited to add Dr. Olivera Finn, Ph.D. and Dr. Mark Frohlich, M.D., two world-renowned immunotherapy experts, to our Scientific Advisory Board,” commented Dr. Lauren V. Wood, M.D., Chief Medical Officer of PDS Biotech. “These appointments further strengthen our translational research expertise in immuno-oncology as we prepare to progress clinical development of PDS0102 and PDS0103 for prostate and MUC-1 associated cancers respectively, and continue to advance our lead cancer immunotherapy PDS0101 through Phase 2 clinical testing. We very much look forward to adding their experience and guidance to our team of accomplished advisors.”

About PDS Biotechnology

PDS Biotech is a clinical-stage immunotherapy company developing a growing pipeline of cancer immunotherapies and infectious disease vaccines based on the Company’s proprietary Versamune® T-cell activating technology platform. Our Versamune®-based products 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. Our immuno-oncology product candidates are initially being studied in combination therapy to potentially enhance efficacy without compounding toxicity across a range of cancer types. The company’s lead investigational cancer immunotherapy product PDS0101 is currently in Phase 2 clinical studies in HPV-associated cancers. PDS Biotech is also collaborating with the National Cancer Institute to develop PDS0102 for prostate and breast cancers and to develop PDS0103, a MUC-1 targeting immunotherapy for breast, colon, lung and ovarian cancers. 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. 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 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; 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: rich@cg.capital

Release – ProMIS Neurosciences Announces First Quarter 2021 Results


ProMIS Neurosciences Announces First Quarter 2021 Results

 

TORONTO, Ontario and CAMBRIDGE, Massachusetts – May 14, 2021 – ProMIS Neurosciences, Inc. (TSX: PMN) (OTCQB: ARFXF) (“ProMIS or the Company”), a biotechnology company focused on the discovery and development of antibody therapeutics targeting toxic oligomers implicated in the development of neurodegenerative diseases, today announced its operational and financial results for the three months ended March 31, 2021.

In the first quarter of 2021, ProMIS, like much of society, started to emerge from “pandemic lockdown”.   Our most important milestone was securing a US $7MM round of financing from a prestigious group of Boston based investors, whose support will allow us to advance our core programs targeting neurodegenerative diseases.    

In addition, in collaboration with Dr. David Wishart of the University of Alberta, we have enhanced and extended our unique technology platform. ProMIS Neurosciences has a unique antibody design capability, which not even the largest pharmaceutical companies have to the best of our knowledge based on ongoing discussions with them. We are able rapidly and cost effectively to design and create antibodies or therapeutic vaccines that only target toxic, mis-folded versions of proteins that otherwise play a normal healthy role. This capability has given ProMIS a growing portfolio of potential “best in class” monoclonal antibodies (or corresponding therapeutic vaccines), including our lead program PMN310, targeting toxic oligomers of amyloid in Alzheimer’s. In the Alzheimer’s field, positive results or regulatory steps were announced by Lilly, Cassava, and Biogen, all of which support the science suggesting PMN310 may be “best in class”.   

Corporate Highlights

  • In January 2021, we announced an outline of our strategic priorities and action plan for 2021. The priorities for 2021 fall into four key areas: near term focus on rare neurodegenerative diseases, especially ALS; use of our proprietary platform to support portfolio expansion; advancement of our PMN310 antibody lead program for Alzheimer’s disease (AD); COVID-19, further progress on serological assays.
  • In February 2021, we announced our perspectives on recent progress in the AD field.
  • Two important events occurred in January 2021, both of which we consider very positive for the AD field, for the updated amyloid hypothesis and for the Company. The Food & Drug Administration extended the Prescription Drug User Fee Act date for review of Biogen’s aducanumab from March 7 to June 7, 2021.  Eli Lilly & Co. announced positive clinical results for their antibody, donanemab, on January 11, 2021, making it the third antibody with positive clinical results in AD, likely due to its targeting of aggregated amyloid-beta (not amyloid monomer). Both these events have positive implications for PMN310.
  • In March 2021, we completed a US$7.0 million (CDN$8.75 million) private placement of unsecured convertible debentures (Debentures). The Debentures are convertible into common shares at the option of the holder at a conversion price of US$0.10 per share and accrue interest at 1% per annum.

People

  • Johannes Minho Roth resigned from the ProMIS Board of Directors in February, taking on a senior executive position at UBS Group AG, a Swiss multinational investment bank and financial services company. We thank Johannes for his excellent contributions to the Board and in support of the Company’s progress. 
  • Michael Grundman, MD, MPH, joins the ProMIS team as senior consultant medical advisor. Dr. Grundman is President and CEO of Global R&D Partners, LLC, a consulting firm that works closely with pharmaceutical and biotechnology companies to develop novel agents for the diagnosis and treatment of serious and life-threatening diseases. Dr. Grundman is Professor of Neurosciences at the University of California San Diego (UCSD). Prior to joining industry, Dr. Grundman was Associate Director of the Alzheimer’s Disease Cooperative Study (ADCS) at the University of California, San Diego (UCSD). He received his BA from New York University magna cum laude with Honors in Biochemistry. He obtained his MD and Neurology training at the Albert Einstein College of Medicine and a Master of Public Health degree from Columbia University.
  • Neil K. Warma, MBA, was appointed to the Board of Directors in May 2021.  Neil Warma has been a successful healthcare entrepreneur for over 25 years having founded, managed and advised numerous biotech and pharmaceutical companies across the globe. Currently, Mr. Warma is the CEO/General Manager of I-Mab Biopharma U.S., (Nasdaq:IMAB) a publicly traded global biopharmaceutical company with offices and research labs in China (Shanghai, Beijing) and the U.S. (San Diego, Gaithersburg) that focuses on developing and commercializing novel immuno oncology drugs. Previously, as President and CEO of Opexa Therapeutics (Nasdaq:OPXA), a publicly traded biopharmaceutical company, Mr. Warma led the turnaround and rebuilding of the company’s cell therapy platform and oversaw its advance through clinical development in autoimmune and orphan diseases, expansion into China and its eventual merger with Acer Therapeutics (Nasdaq:ACER). Prior to Opexa, he was CEO of Viron Therapeutics, a private biotechnology company developing novel protein-based therapeutics for cardiovascular disease and transplantation.

Financial Results

Results of Operations – Three months ended March 31, 2021 and 2020

Net loss for the three months ended March 31, 2021 was $7,599,417, compared to a net loss of $1,761,919 in the three months ended March 31, 2020.  Included in the net loss for the three months ended March 31, 2021 were non-cash expenses of 7,054,543, representing the change in the fair value of an embedded derivative associated with the Debenture financing, reversal of share-based compensation due to the forfeiture of unvested share options, foreign exchange loss, amortization of property and equipment and amortization of an intangible asset, compared to $213,737 for the three months ended March 31, 2020.  

Operating loss before non-cash expenses for the three months ended March 31, 2021 was $582,331, as compared to $1,761,919 in the three months ended March 31, 2020. The decrease in the operating loss for the three months ended March 31, 2021 reflects decreased costs associated with external contract research organizations for internal programs, patent costs, share-based compensation due to the forfeiture of unvested share options, contracted salaries and associated costs and general corporate expenditures offset by an increase in professional fees.   

Research and development expenses for the three months ended March 31, 2021 were $193,923, as compared to $973,586 in the three months ended March 31, 2020. The decrease in research and development expense for the three months ended March 31, 2021, compared to the same period ended March 31, 2020 reflects the conservation of cash resources and decreased costs associated with external contract research organizations for internal programs, reduced patent expense, share-based compensation due to the forfeiture of unvested share options, contracted research salaries and associated costs and external consulting expense.

General and administrative expenses for the three months ended March 31, 2021 were $388,408, as compared to $788,346 in the three months ended March 31, 2019.  The decrease for the three months ended March 31, 2021, compared to the same period in 2020, is primarily attributable to a reduction in contracted corporate salaries and associated costs, share-based compensation and a decrease in foreign exchange losses expense offset by consulting and professional fees. 

Outlook

Going forward ProMIS will focus on accelerating or re-initiating programs in our core business area, best in class therapeutics for neurodegenerative diseases.  In addition, we will continue to expand the application of our unique discovery platform, with which we can “rationally design” antibodies or vaccines to be selective for only mis-folded, pathogenic proteins involved in disease.    

In Alzheimer’s we will restart IND enabling work for PMN310, our antibody highly selective for toxic oligomers of amyloid. That selectivity may prove to give PMN310 significant competitive advantages in safety and efficacy over products from Biogen, Lilly, and Eisai that appear to provide benefit slowing the progression of Alzheimer’s disease. In addition, starting with the same proprietary technology that creates selective antibodies (“passive” immunotherapy), we are moving forward our program to create therapeutic vaccines (“active” immunotherapy) targeting toxic oligomers of amyloid. Therapeutic vaccines may be a preferred therapy for Alzheimer’s prevention; the ultimate goal in Alzheimer’s treatment is to detect disease in the ~20 year window before symptoms arise and treat to prevent symptoms of cognitive decline.

In ALS we will advance our program targeting toxic TDP-43 with further in vitro and in vivo validation, and we will build on the significant scientific advances we have made targeting RACK1 (Receptor for A Activated C Kinase 1). We will also further advance our alpha-synuclein program with further in vivo and in vitro validation, targeting diseases like Parkinson’s disease and Multiple System Atrophy.

About ProMIS Neurosciences, Inc.

ProMIS Neurosciences, Inc. is a development-stage biotechnology company focused on discovering and developing antibody therapeutics selectively targeting toxic oligomers implicated in the development and progression of neurodegenerative diseases, in particular Alzheimer’s disease (AD), amyotrophic lateral sclerosis (ALS) and Parkinson’s disease (PD). The Company’s proprietary target discovery engine is based on the use of two complementary techniques. The Company applies its thermodynamic, computational discovery platform -ProMIS and Collective Coordinates – to predict novel targets known as Disease Specific Epitopes on the molecular surface of misfolded proteins. Using this unique approach, the Company is developing novel antibody therapeutics for AD, ALS and PD.  ProMIS is headquartered in Toronto, Ontario, with offices in Cambridge, Massachusetts. ProMIS is listed on the Toronto Stock Exchange under the symbol PMN, and on the OTCQB Venture Market under the symbol ARFXF.

Visit us at www.promisneurosciences.com, follow us on Twitter and LinkedIn

For Investor Relations please contact:

Alpine Equity Advisors
Nicholas Rigopulos, President
nick@alpineequityadv.com
Tel. 617 901-0785

The TSX has not reviewed and does not accept responsibility for the adequacy or accuracy of this release. This information release contains certain forward-looking information. Such information involves known and unknown risks, uncertainties and other factors that may cause actual results, performance or achievements to be materially different from those implied by statements herein, and therefore these statements should not be read as guarantees of future performance or results. All forward-looking statements are based on the Company’s current beliefs as well as assumptions made by and information currently available to it as well as other factors. Readers are cautioned not to place undue reliance on these forward-looking statements, which speak only as of the date of this press release. Due to risks and uncertainties, including the risks and uncertainties identified by the Company in its public securities filings, actual events may differ materially from current expectations. The Company disclaims any intention or obligation to update or revise any forward-looking statements, whether as a result of new information, future events or otherwise.

PDS Biotech (PDSB) – PDS Biotech Receives $4.5M After Selling Its Net Operating Loss Tax Benefits

 


PDS Biotech Receives $4.5M After Selling Its Net Operating Loss Tax Benefits Through The New Jersey Economic Development Program

 

FLORHAM PARK, N.J., May 17, 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, today announced the receipt of $4.5 million from the net sale of tax benefits to an unrelated, profitable New Jersey corporation pursuant to the Company’s participation in the New Jersey Technology Business Tax Certificate Transfer Net Operating Loss (NOL) program for State Fiscal Year 2020.

“We are pleased to receive an allocation from the New Jersey NOL program,” said Frank Bedu-Addo, Chief Executive Officer of PDS Biotech. “The funding will be beneficial to us as we continue to efficiently utilize our resources to advance our immuno-oncology pipeline through development.”

The NOL program enables qualified, unprofitable NJ-based technology or biotechnology companies with fewer than 225 U.S. employees (including parent company and all subsidiaries) to sell a percentage of net operating losses and research and development (R&D) tax credits to unrelated profitable corporations. This allows qualifying technology and biotechnology companies with NOLs to turn their tax losses and credits into cash proceeds to fund growth and operations, including research and development or other allowable expenditures. PDS Biotech is one of 49 early-stage companies to share in approximately $54.5 million of tax credit transfers approved by NJEDA for the 2020 period.

About PDS Biotechnology

PDS Biotech is a clinical-stage immunotherapy company developing a growing pipeline of cancer immunotherapies and infectious disease vaccines based on the Company’s proprietary Versamune® T-cell activating technology platform. Our Versamune®-based products 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. Our immuno-oncology product candidates are initially being studied in combination therapy to potentially enhance efficacy without compounding toxicity across a range of cancer types. The company’s lead investigational cancer immunotherapy product PDS0101 is currently in Phase 2 clinical studies in HPV-associated cancers. 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 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; 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: rich@cg.capital

Cocrystal Pharma (COCP) – Reports First Quarter 2021 Financial Results and Provides Business Update


Cocrystal Pharma Reports First Quarter 2021 Financial Results and Provides Business Update

 

BOTHELL, Wash., May 17, 2021 (GLOBE NEWSWIRE) — Cocrystal Pharma, Inc. (Nasdaq: COCP) (“Cocrystal” or the “Company”), a clinical-stage biotechnology company discovering and developing novel antiviral therapeutics that target the replication machinery of influenza viruses, the SARS-CoV-2 virus, hepatitis C viruses and noroviruses, reports financial results for the three months ended March 31, 2021 and provides updates on its antiviral pipeline and business activities.  

“We believe Cocrystal is well-positioned to advance the discovery and development of novel antiviral compounds to address major global medical concerns and create significant market opportunities for our company,” said Gary Wilcox, Ph.D., Chairman and Chief Executive Officer of Cocrystal. “Following the successful financing completed earlier this month, we believe we have sufficient capital to fund our currently planned operations and product development programs through 2024.”

“We remain on track to achieve key milestones this year with our coronavirus, norovirus and influenza A antiviral programs,” said Sam Lee, Ph.D., President of Cocrystal. “As discussed in our coronavirus update release earlier this month, we continue developing novel SARS-CoV-2 oral protease inhibitors and are rapidly advancing lead compounds. We recently demonstrated strong in vitro synergistic effect between remdesivir and our protease inhibitor CDI-45205 and are currently examining in vitro activity of our SARS-CoV-2 3CL protease inhibitors against emerging SARS-CoV-2 variants.

“We also expect to report initial proof-of-concept mouse-model read-out with our norovirus protease inhibitors next month,” added Dr. Lee. “We believe that by targeting viral protease we may develop an effective treatment for norovirus gastroenteritis. This is a significant opportunity for Cocrystal given the lack of any effective antiviral treatment or vaccine for norovirus gastroenteritis, and the limited ability to curtail outbreaks of this highly contagious virus that causes symptoms of acute gastroenteritis.

“With our program for the treatment of seasonal and pandemic influenza, we are completing the remaining IND-enabling studies with CC-42344 with preparations underway to initiate a Phase 1 study in the third quarter of this year. We look forward to providing additional details about this program including announcing our clinical strategy,” Dr. Lee concluded.

Antiviral Development Pipeline Milestones and Updates

COVID-19 Programs

  • In December 2020 we announced the selection of CDI-45205 as the lead compound for further development against coronaviruses including SARS-CoV-2, that causes COVID-19. CDI-45205 was one of the broad-spectrum protease inhibitors that were obtained from Kansas State University Research Foundation (“KSURF”) under an exclusive license agreement announced in April 2020. That agreement provides Cocrystal with an exclusive, royalty-bearing license to develop and commercialize therapeutic, diagnostic and prophylactic products against coronaviruses, caliciviruses and picornaviruses based on antivirals discovered by KSURF. The Company believes the 3CL protease has the ability to convert the inactive SARS-CoV-2 replication enzymes into the active form. CDI-45205 showed good bioavailability in mouse and rat pharmacokinetic studies via intraperitoneal injection, and also no cytotoxicity against a variety of human cell lines.

The Company recently demonstrated a strong in vitro synergistic effect with the FDA-approved COVID-19 medicine remdesivir. Additionally, a proof-of-concept animal study demonstrated that daily injection of CDI-45205 exhibited favorable in vivo efficacy in MERS-CoV-2 infected mice. The Company has initiated scale-up synthesis and process chemistry development and is working toward pre-IND status with CDI-45205.

  • Cocrystal has leveraged its antiviral development expertise by using its proprietary technology and drug discovery platform to launch two additional COVID-19 programs, novel SARS-CoV-2 3CL protease inhibitors and replication inhibitors. The Company anticipates identifying another SARS-CoV-2 preclinical 3CL lead for oral administration this year.

By targeting the viral replication enzymes and proteases, Cocrystal believes it is possible to develop effective treatments for all coronaviruses that cause COVID-19, Severe Acute Respiratory Syndrome (SARS) and Middle East Respiratory Syndrome (MERS).

Influenza A Program

  • Completing IND-enabling activities with CC-42344 with planned Phase 1 study initiation during the third quarter of 2021. CC-42344 showed excellent antiviral activity against influenza A strains, including avian pandemic strains and Tamiflu-resistant strains, and has a favorable pharmacokinetic profile.

Influenza remains a major global concern. The World Health Organization (WHO) estimates approximately 1 billion cases of influenza annually worldwide, resulting in 3 million to 5 million cases of severe illness and 250,000 to 500,000 deaths. Approved influenza therapies have major limitations due to drug resistance and viral mutation. Cocrystal is designing influenza drug candidates to be active against drug-resistant strains, effective against future mutations and available through multiple routes of administration including oral, inhalation and injection.

Hepatitis C Program

  • We have been seeking a partner to advance the development of CC-31244 since completing Phase 2a trials. This compound showed favorable safety and preliminary efficacy in a triple regimen Phase 2a study in combination with Epclusa (sofosbuvir/velpatasvir) for the ultra-short treatment of individuals infected with the hepatitis C virus (HCV). To date, no other company has developed a short-duration HCV treatment of 4 weeks or less with a high (>95%) sustained virologic response (SVR) at week 12.

HCV is a viral infection of the liver that causes both acute and chronic infection. According to the WHO, in 2017 HCV chronically affected an estimated 71 million people worldwide, including 3.5 million in the U.S. Approximately 399,000 people die each year from hepatitis C infection, mostly from cirrhosis and hepatocellular carcinoma.

Norovirus Program

  • Completion of a proof-of-concept animal study is expected in the second quarter of 2021 with a broad-spectrum norovirus protease polymerase inhibitor. Cocrystal is further developing certain proprietary broad-spectrum antiviral compounds to treat norovirus infections under its license agreement with KSURF.

Norovirus is a public health problem responsible for nearly 90% of epidemic, non-bacterial outbreaks of gastroenteritis around the world. Norovirus is a very common and highly contagious virus that causes symptoms of acute gastroenteritis including nausea, vomiting, stomach pain and diarrhea. 

First Quarter 2021 and Recent Highlights

Licensing and Collaboration Agreements

  • Completed all research obligations under the Merck exclusive worldwide license and collaboration agreement for influenza A/B antiviral compounds. As of mid-January 2021, Merck assumed all responsibility for further program development.
  • Extended a drug discovery collaboration with HitGen and InterX, combining three independent platforms to discover and optimize molecules that may lead to novel antiviral drug candidates.

Research and Development

  • Continued IND-enabling studies with influenza PB2 inhibitor CC-42344 in preparation for initiating a Phase 1 clinical study in the third quarter of 2021.
  • Developed scale-up synthesis of SARS-CoV-2 3CL protease inhibitor CDI-45205.
  • Initiated SARS-CoV-2 3CL oral protease inhibitor program.
  • Initiated SARS-CoV-2 replication inhibitor program.
  • Continued proof-of-concept mouse norovirus model study with expected initial read-out in June 2021.

Scientific Presentation

  • Presented an overview of Cocrystal’s drug discovery platform technology, including its unique ability to develop broad-spectrum antiviral therapeutics and its advantages compared with the traditional drug discovery and development process, at the “reimagine Health Research Symposium” in January 2021.

Financial Developments

  • In May 2021, completed raise of $36.4 million in net proceeds from a public offering of common stock.

First Quarter Financial Results

Throughout 2020 Cocrystal reported quarterly revenues under an influenza A/B collaboration with Merck consisting of research and development (R&D) services performed by Cocrystal and reimbursed by Merck. In mid-January 2021 Merck assumed all activities and expenses associated with the continued development of the influenza A/B compounds discovered under this collaboration. As anticipated, Cocrystal reported no revenues for the first quarter of 2021 compared with $461,000 in revenues for the first quarter of 2020. Under the terms of the Merck collaboration, Cocrystal is eligible to receive up to $156 million in future payments related to designated development, regulatory and sales milestones, as well as royalties on product sales.

R&D expenses for the first quarter of 2021 were $1.6 million compared with $1.3 million for the first quarter of 2020, with the increase primarily related to increased spending on our COVID-19 and influenza programs. General and administrative expenses for the first quarter of 2021 were $1.2 million versus $1.1 million for the prior-year quarter, with the increase primarily due to insurance and professional fees.

The net loss for the first quarter of 2021 was $2.7 million, or $0.04 per share, compared with a net loss for the first quarter of 2020 of $2.0 million, or $0.05 per share.

The Company reported cash and cash equivalents of $33.3 million as of March 31, 2021, compared with $33.0 million as of December 31, 2020. The Company reported working capital of $32.2 million as of March 31, 2021.

In May 2021, Cocrystal closed an underwritten public offering of 26,000,000 shares of common stock at a price to the public of $1.54 per share, and received net proceeds of approximately $36.4 million less underwriting discounts and commissions.

About Cocrystal Pharma, Inc.
Cocrystal Pharma, Inc. is a clinical-stage biotechnology company discovering and developing novel antiviral therapeutics that target the replication process of influenza viruses, coronaviruses (including SARS-CoV-2), hepatitis C viruses and noroviruses. Cocrystal employs unique structure-based technologies and Nobel Prize-winning expertise to create first- and best-in-class antiviral drugs. For further information about Cocrystal, please visit www.cocrystalpharma.com.

Cautionary Note Regarding Forward-Looking Statements
This press release contains forward-looking statements within the meaning of the Private Securities Litigation Reform Act of 1995, including statements regarding the expected future success of our discovery and development activities in addressing major global medical concerns, the expected achievement of key milestones in our antiviral programs and the anticipated timing of achieving such milestones, including reporting proof-of-concept mouse-model read-out with our norovirus protease inhibitors in June 2021, the planned initiation of the influenza A Phase 1 study during the third quarter of 2021, identifying another SARS-CoV-2 preclinical 3CL lead for oral administration in 2021, and our plans regarding the expected completion of a norovirus proof-of-concept animal study in the second quarter of 2021; our expectations and estimates regarding the future applications and effectiveness of, and the market opportunities for, our product candidates; the expected results of Cocrystal’s extended collaboration with HitGen and InterX; and future liquidity. The words “believe,” “may,” “estimate,” “continue,” “anticipate,” “intend,” “should,” “plan,” “could,” “target,” “potential,” “is likely,” “will,” “expect” and similar expressions, as they relate to us, are intended to identify forward-looking statements. We have based these forward-looking statements largely on our current expectations and projections about future events. Some or all of the events anticipated by these forward-looking statements may not occur. Important factors that could cause actual results to differ from those in the forward-looking statements include, but are not limited to, the risks arising from the impact of the COVID-19 pandemic on the national and global economy, on our collaboration partners and on our Company, including supply chain disruptions and our continued ability to proceed with our programs, our reliance on Merck for further development in the influenza A/B program under the license and collaboration agreement, HitGen’s DNA Encoded Library technology and InterX’s software performing as expected, the results of future preclinical and clinical studies, general risks arising from clinical trials, receipt of regulatory approvals, regulatory changes, and development of effective treatments and/or vaccines by competitors, including as part of the programs financed by the U.S. government. Further information on our risk factors is contained in our filings with the SEC, including our Annual Report on Form 10-K for the year ended December 31, 2020. Any forward-looking statement made by us herein speaks only as of the date on which it is made. Factors or events that could cause our actual results to differ may emerge from time to time, and it is not possible for us to predict all of them. We undertake no obligation to publicly update any forward-looking statement, whether as a result of new information, future developments or otherwise, except as may be required by law.

Investor Contact:
LHA Investor Relations
Jody Cain
310-691-7100
jcain@lhai.com

COCRYSTAL PHARMA, INC. 
CONSOLIDATED BALANCE SHEETS
(in thousands)

    March 31, 2021     December 31, 2020  
      (unaudited)          
Assets                
Current assets:                
Cash   $ 33,278     $ 33,010  
Restricted cash     50       50  
Accounts receivable           556  
Prepaid expenses and other current assets     363       399  
Total current assets     33,691       34,015  
Property and equipment, net     571       591  
Deposits     46       46  
Operating lease right-of-use assets, net (including $25 and $39 to related party)     451       498  
Goodwill     19,092       19,092  
Total assets   $ 53,851     $ 54,242  
Liabilities and stockholders’ equity                
Current liabilities:                
Accounts payable and accrued expenses   $ 1,194     $ 1,080  
Current maturities of finance lease liabilities     36       39  
Current maturities of operating lease liabilities (including $25 and $39 to related party)     167       178  
Derivative liabilities     60       61  
Total current liabilities     1,457       1,358  
Long-term liabilities:                
Finance lease liabilities     28       34  
Operating lease liabilities     308       345  
Total long-term liabilities     336       379  
Total liabilities     1,793       1,737  
Commitments and contingencies                
Stockholders’ equity:                
Common stock, $0.001 par value; 100,000 shares authorized as of March 31, 2021 and December 31, 2020; 71,469,000 and 70,439 shares issued and outstanding as of March 31, 2021 and December 31, 2020, respectively     72       71  
Additional paid-in capital     299,632       297,342  
Accumulated deficit     (247,646 )     (244,908 )
Total stockholders’ equity     52,058       52,505  
Total liabilities and stockholders’ equity   $ 53,851     $ 54,242  

COCRYSTAL PHARMA, INC. 
CONSOLIDATED STATEMENTS OF OPERATIONS
(in thousands, except per share data)

    Three months ended
March 31,
 
    2021     2020  
Revenues:                
Collaboration revenue   $     $ 461  
Operating expenses:                
Research and development     1,577       1,283  
General and administrative     1,161       1,139  
Total operating expenses     2,738       2,422  
                 
Loss from operations     (2,738 )     (1,961 )
Other (expense) income:                
Interest expense, net     (1 )     (2 )
Change in fair value of derivative liabilities     1       (27 )
Total other expense, net           (29 )
Net loss   $ (2,738 )   $ (1,990 )
Net loss per common share, basic and diluted   $ (0.04 )   $ (0.05 )
Weighted average number of common shares outstanding, basic and diluted     71,248       41,662  

Source: Cocrystal Pharma, Inc.

Release – Cocrystal Pharma (COCP) – Reports First Quarter 2021 Financial Results and Provides Business Update


Cocrystal Pharma Reports First Quarter 2021 Financial Results and Provides Business Update

 

BOTHELL, Wash., May 17, 2021 (GLOBE NEWSWIRE) — Cocrystal Pharma, Inc. (Nasdaq: COCP) (“Cocrystal” or the “Company”), a clinical-stage biotechnology company discovering and developing novel antiviral therapeutics that target the replication machinery of influenza viruses, the SARS-CoV-2 virus, hepatitis C viruses and noroviruses, reports financial results for the three months ended March 31, 2021 and provides updates on its antiviral pipeline and business activities.  

“We believe Cocrystal is well-positioned to advance the discovery and development of novel antiviral compounds to address major global medical concerns and create significant market opportunities for our company,” said Gary Wilcox, Ph.D., Chairman and Chief Executive Officer of Cocrystal. “Following the successful financing completed earlier this month, we believe we have sufficient capital to fund our currently planned operations and product development programs through 2024.”

“We remain on track to achieve key milestones this year with our coronavirus, norovirus and influenza A antiviral programs,” said Sam Lee, Ph.D., President of Cocrystal. “As discussed in our coronavirus update release earlier this month, we continue developing novel SARS-CoV-2 oral protease inhibitors and are rapidly advancing lead compounds. We recently demonstrated strong in vitro synergistic effect between remdesivir and our protease inhibitor CDI-45205 and are currently examining in vitro activity of our SARS-CoV-2 3CL protease inhibitors against emerging SARS-CoV-2 variants.

“We also expect to report initial proof-of-concept mouse-model read-out with our norovirus protease inhibitors next month,” added Dr. Lee. “We believe that by targeting viral protease we may develop an effective treatment for norovirus gastroenteritis. This is a significant opportunity for Cocrystal given the lack of any effective antiviral treatment or vaccine for norovirus gastroenteritis, and the limited ability to curtail outbreaks of this highly contagious virus that causes symptoms of acute gastroenteritis.

“With our program for the treatment of seasonal and pandemic influenza, we are completing the remaining IND-enabling studies with CC-42344 with preparations underway to initiate a Phase 1 study in the third quarter of this year. We look forward to providing additional details about this program including announcing our clinical strategy,” Dr. Lee concluded.

Antiviral Development Pipeline Milestones and Updates

COVID-19 Programs

  • In December 2020 we announced the selection of CDI-45205 as the lead compound for further development against coronaviruses including SARS-CoV-2, that causes COVID-19. CDI-45205 was one of the broad-spectrum protease inhibitors that were obtained from Kansas State University Research Foundation (“KSURF”) under an exclusive license agreement announced in April 2020. That agreement provides Cocrystal with an exclusive, royalty-bearing license to develop and commercialize therapeutic, diagnostic and prophylactic products against coronaviruses, caliciviruses and picornaviruses based on antivirals discovered by KSURF. The Company believes the 3CL protease has the ability to convert the inactive SARS-CoV-2 replication enzymes into the active form. CDI-45205 showed good bioavailability in mouse and rat pharmacokinetic studies via intraperitoneal injection, and also no cytotoxicity against a variety of human cell lines.

The Company recently demonstrated a strong in vitro synergistic effect with the FDA-approved COVID-19 medicine remdesivir. Additionally, a proof-of-concept animal study demonstrated that daily injection of CDI-45205 exhibited favorable in vivo efficacy in MERS-CoV-2 infected mice. The Company has initiated scale-up synthesis and process chemistry development and is working toward pre-IND status with CDI-45205.

  • Cocrystal has leveraged its antiviral development expertise by using its proprietary technology and drug discovery platform to launch two additional COVID-19 programs, novel SARS-CoV-2 3CL protease inhibitors and replication inhibitors. The Company anticipates identifying another SARS-CoV-2 preclinical 3CL lead for oral administration this year.

By targeting the viral replication enzymes and proteases, Cocrystal believes it is possible to develop effective treatments for all coronaviruses that cause COVID-19, Severe Acute Respiratory Syndrome (SARS) and Middle East Respiratory Syndrome (MERS).

Influenza A Program

  • Completing IND-enabling activities with CC-42344 with planned Phase 1 study initiation during the third quarter of 2021. CC-42344 showed excellent antiviral activity against influenza A strains, including avian pandemic strains and Tamiflu-resistant strains, and has a favorable pharmacokinetic profile.

Influenza remains a major global concern. The World Health Organization (WHO) estimates approximately 1 billion cases of influenza annually worldwide, resulting in 3 million to 5 million cases of severe illness and 250,000 to 500,000 deaths. Approved influenza therapies have major limitations due to drug resistance and viral mutation. Cocrystal is designing influenza drug candidates to be active against drug-resistant strains, effective against future mutations and available through multiple routes of administration including oral, inhalation and injection.

Hepatitis C Program

  • We have been seeking a partner to advance the development of CC-31244 since completing Phase 2a trials. This compound showed favorable safety and preliminary efficacy in a triple regimen Phase 2a study in combination with Epclusa (sofosbuvir/velpatasvir) for the ultra-short treatment of individuals infected with the hepatitis C virus (HCV). To date, no other company has developed a short-duration HCV treatment of 4 weeks or less with a high (>95%) sustained virologic response (SVR) at week 12.

HCV is a viral infection of the liver that causes both acute and chronic infection. According to the WHO, in 2017 HCV chronically affected an estimated 71 million people worldwide, including 3.5 million in the U.S. Approximately 399,000 people die each year from hepatitis C infection, mostly from cirrhosis and hepatocellular carcinoma.

Norovirus Program

  • Completion of a proof-of-concept animal study is expected in the second quarter of 2021 with a broad-spectrum norovirus protease polymerase inhibitor. Cocrystal is further developing certain proprietary broad-spectrum antiviral compounds to treat norovirus infections under its license agreement with KSURF.

Norovirus is a public health problem responsible for nearly 90% of epidemic, non-bacterial outbreaks of gastroenteritis around the world. Norovirus is a very common and highly contagious virus that causes symptoms of acute gastroenteritis including nausea, vomiting, stomach pain and diarrhea. 

First Quarter 2021 and Recent Highlights

Licensing and Collaboration Agreements

  • Completed all research obligations under the Merck exclusive worldwide license and collaboration agreement for influenza A/B antiviral compounds. As of mid-January 2021, Merck assumed all responsibility for further program development.
  • Extended a drug discovery collaboration with HitGen and InterX, combining three independent platforms to discover and optimize molecules that may lead to novel antiviral drug candidates.

Research and Development

  • Continued IND-enabling studies with influenza PB2 inhibitor CC-42344 in preparation for initiating a Phase 1 clinical study in the third quarter of 2021.
  • Developed scale-up synthesis of SARS-CoV-2 3CL protease inhibitor CDI-45205.
  • Initiated SARS-CoV-2 3CL oral protease inhibitor program.
  • Initiated SARS-CoV-2 replication inhibitor program.
  • Continued proof-of-concept mouse norovirus model study with expected initial read-out in June 2021.

Scientific Presentation

  • Presented an overview of Cocrystal’s drug discovery platform technology, including its unique ability to develop broad-spectrum antiviral therapeutics and its advantages compared with the traditional drug discovery and development process, at the “reimagine Health Research Symposium” in January 2021.

Financial Developments

  • In May 2021, completed raise of $36.4 million in net proceeds from a public offering of common stock.

First Quarter Financial Results

Throughout 2020 Cocrystal reported quarterly revenues under an influenza A/B collaboration with Merck consisting of research and development (R&D) services performed by Cocrystal and reimbursed by Merck. In mid-January 2021 Merck assumed all activities and expenses associated with the continued development of the influenza A/B compounds discovered under this collaboration. As anticipated, Cocrystal reported no revenues for the first quarter of 2021 compared with $461,000 in revenues for the first quarter of 2020. Under the terms of the Merck collaboration, Cocrystal is eligible to receive up to $156 million in future payments related to designated development, regulatory and sales milestones, as well as royalties on product sales.

R&D expenses for the first quarter of 2021 were $1.6 million compared with $1.3 million for the first quarter of 2020, with the increase primarily related to increased spending on our COVID-19 and influenza programs. General and administrative expenses for the first quarter of 2021 were $1.2 million versus $1.1 million for the prior-year quarter, with the increase primarily due to insurance and professional fees.

The net loss for the first quarter of 2021 was $2.7 million, or $0.04 per share, compared with a net loss for the first quarter of 2020 of $2.0 million, or $0.05 per share.

The Company reported cash and cash equivalents of $33.3 million as of March 31, 2021, compared with $33.0 million as of December 31, 2020. The Company reported working capital of $32.2 million as of March 31, 2021.

In May 2021, Cocrystal closed an underwritten public offering of 26,000,000 shares of common stock at a price to the public of $1.54 per share, and received net proceeds of approximately $36.4 million less underwriting discounts and commissions.

About Cocrystal Pharma, Inc.
Cocrystal Pharma, Inc. is a clinical-stage biotechnology company discovering and developing novel antiviral therapeutics that target the replication process of influenza viruses, coronaviruses (including SARS-CoV-2), hepatitis C viruses and noroviruses. Cocrystal employs unique structure-based technologies and Nobel Prize-winning expertise to create first- and best-in-class antiviral drugs. For further information about Cocrystal, please visit www.cocrystalpharma.com.

Cautionary Note Regarding Forward-Looking Statements
This press release contains forward-looking statements within the meaning of the Private Securities Litigation Reform Act of 1995, including statements regarding the expected future success of our discovery and development activities in addressing major global medical concerns, the expected achievement of key milestones in our antiviral programs and the anticipated timing of achieving such milestones, including reporting proof-of-concept mouse-model read-out with our norovirus protease inhibitors in June 2021, the planned initiation of the influenza A Phase 1 study during the third quarter of 2021, identifying another SARS-CoV-2 preclinical 3CL lead for oral administration in 2021, and our plans regarding the expected completion of a norovirus proof-of-concept animal study in the second quarter of 2021; our expectations and estimates regarding the future applications and effectiveness of, and the market opportunities for, our product candidates; the expected results of Cocrystal’s extended collaboration with HitGen and InterX; and future liquidity. The words “believe,” “may,” “estimate,” “continue,” “anticipate,” “intend,” “should,” “plan,” “could,” “target,” “potential,” “is likely,” “will,” “expect” and similar expressions, as they relate to us, are intended to identify forward-looking statements. We have based these forward-looking statements largely on our current expectations and projections about future events. Some or all of the events anticipated by these forward-looking statements may not occur. Important factors that could cause actual results to differ from those in the forward-looking statements include, but are not limited to, the risks arising from the impact of the COVID-19 pandemic on the national and global economy, on our collaboration partners and on our Company, including supply chain disruptions and our continued ability to proceed with our programs, our reliance on Merck for further development in the influenza A/B program under the license and collaboration agreement, HitGen’s DNA Encoded Library technology and InterX’s software performing as expected, the results of future preclinical and clinical studies, general risks arising from clinical trials, receipt of regulatory approvals, regulatory changes, and development of effective treatments and/or vaccines by competitors, including as part of the programs financed by the U.S. government. Further information on our risk factors is contained in our filings with the SEC, including our Annual Report on Form 10-K for the year ended December 31, 2020. Any forward-looking statement made by us herein speaks only as of the date on which it is made. Factors or events that could cause our actual results to differ may emerge from time to time, and it is not possible for us to predict all of them. We undertake no obligation to publicly update any forward-looking statement, whether as a result of new information, future developments or otherwise, except as may be required by law.

Investor Contact:
LHA Investor Relations
Jody Cain
310-691-7100
jcain@lhai.com

COCRYSTAL PHARMA, INC. 
CONSOLIDATED BALANCE SHEETS
(in thousands)

    March 31, 2021     December 31, 2020  
      (unaudited)          
Assets                
Current assets:                
Cash   $ 33,278     $ 33,010  
Restricted cash     50       50  
Accounts receivable           556  
Prepaid expenses and other current assets     363       399  
Total current assets     33,691       34,015  
Property and equipment, net     571       591  
Deposits     46       46  
Operating lease right-of-use assets, net (including $25 and $39 to related party)     451       498  
Goodwill     19,092       19,092  
Total assets   $ 53,851     $ 54,242  
Liabilities and stockholders’ equity                
Current liabilities:                
Accounts payable and accrued expenses   $ 1,194     $ 1,080  
Current maturities of finance lease liabilities     36       39  
Current maturities of operating lease liabilities (including $25 and $39 to related party)     167       178  
Derivative liabilities     60       61  
Total current liabilities     1,457       1,358  
Long-term liabilities:                
Finance lease liabilities     28       34  
Operating lease liabilities     308       345  
Total long-term liabilities     336       379  
Total liabilities     1,793       1,737  
Commitments and contingencies                
Stockholders’ equity:                
Common stock, $0.001 par value; 100,000 shares authorized as of March 31, 2021 and December 31, 2020; 71,469,000 and 70,439 shares issued and outstanding as of March 31, 2021 and December 31, 2020, respectively     72       71  
Additional paid-in capital     299,632       297,342  
Accumulated deficit     (247,646 )     (244,908 )
Total stockholders’ equity     52,058       52,505  
Total liabilities and stockholders’ equity   $ 53,851     $ 54,242  

COCRYSTAL PHARMA, INC. 
CONSOLIDATED STATEMENTS OF OPERATIONS
(in thousands, except per share data)

    Three months ended
March 31,
 
    2021     2020  
Revenues:                
Collaboration revenue   $     $ 461  
Operating expenses:                
Research and development     1,577       1,283  
General and administrative     1,161       1,139  
Total operating expenses     2,738       2,422  
                 
Loss from operations     (2,738 )     (1,961 )
Other (expense) income:                
Interest expense, net     (1 )     (2 )
Change in fair value of derivative liabilities     1       (27 )
Total other expense, net           (29 )
Net loss   $ (2,738 )   $ (1,990 )
Net loss per common share, basic and diluted   $ (0.04 )   $ (0.05 )
Weighted average number of common shares outstanding, basic and diluted     71,248       41,662  

Source: Cocrystal Pharma, Inc.

Release – PDS Biotech (PDSB) – PDS Biotech Receives $4.5M After Selling Its Net Operating Loss Tax Benefits

 


PDS Biotech Receives $4.5M After Selling Its Net Operating Loss Tax Benefits Through The New Jersey Economic Development Program

 

FLORHAM PARK, N.J., May 17, 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, today announced the receipt of $4.5 million from the net sale of tax benefits to an unrelated, profitable New Jersey corporation pursuant to the Company’s participation in the New Jersey Technology Business Tax Certificate Transfer Net Operating Loss (NOL) program for State Fiscal Year 2020.

“We are pleased to receive an allocation from the New Jersey NOL program,” said Frank Bedu-Addo, Chief Executive Officer of PDS Biotech. “The funding will be beneficial to us as we continue to efficiently utilize our resources to advance our immuno-oncology pipeline through development.”

The NOL program enables qualified, unprofitable NJ-based technology or biotechnology companies with fewer than 225 U.S. employees (including parent company and all subsidiaries) to sell a percentage of net operating losses and research and development (R&D) tax credits to unrelated profitable corporations. This allows qualifying technology and biotechnology companies with NOLs to turn their tax losses and credits into cash proceeds to fund growth and operations, including research and development or other allowable expenditures. PDS Biotech is one of 49 early-stage companies to share in approximately $54.5 million of tax credit transfers approved by NJEDA for the 2020 period.

About PDS Biotechnology

PDS Biotech is a clinical-stage immunotherapy company developing a growing pipeline of cancer immunotherapies and infectious disease vaccines based on the Company’s proprietary Versamune® T-cell activating technology platform. Our Versamune®-based products 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. Our immuno-oncology product candidates are initially being studied in combination therapy to potentially enhance efficacy without compounding toxicity across a range of cancer types. The company’s lead investigational cancer immunotherapy product PDS0101 is currently in Phase 2 clinical studies in HPV-associated cancers. 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 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; 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: rich@cg.capital

Ayala Pharmaceuticals (AYLA) – Reports First Quarter 2021 Financial Results and Provides Business Update


Ayala Pharmaceuticals Reports First Quarter 2021 Financial Results and Provides Business Update

 

        – First Patient Dosed in Phase 1 AL102 Combination Trial with Novartis’ Anti-BCMA Agent for the Treatment of Multiple Myeloma –

– On Track to Initiate AL102 Phase 2/3 Pivotal Trial for the Treatment of Desmoid Tumors in 1H21-

– Multiple Near-Term Milestones Expected Across Clinical-Stage Pipeline –

REHOVOT, Israel and WILMINGTON, Del., May 14, 2021 (GLOBE NEWSWIRE) — Ayala Pharmaceuticals, Inc. (Nasdaq: AYLA), a clinical-stage oncology company focused on developing and commercializing small molecule therapeutics for patients suffering from rare and aggressive cancers, primarily in genetically defined patient populations, today reported financial results for the first quarter ended March 31, 2021 and highlighted recent progress and upcoming milestones for its pipeline programs.

“Continuing on the strong momentum set in 2020, we are pleased with our progress through the first quarter of 2021. With a strengthened balance sheet and extended cash runway into 2023, we are well positioned to further progress our innovative pipeline of assets targeting the inhibition of gamma secretase through key pathways implicated in rare and aggressive cancers, including adenoid cystic carcinoma, multiple myeloma, triple negative breast cancer and desmoid tumors,” said Roni Mamluk, Ph.D., Chief Executive Officer of Ayala. “We have made great strides to advance our pipeline programs in 2021 with the first patients dosed in both the Phase 2 TENACITY trial in triple negative breast cancer and the Phase 1 combination trial with Novartis in multiple myeloma. We also remain on track to report additional data from the 6mg cohort of our Phase 2 ACCURACY trial of AL101 for the treatment of adenoid cystic carcinoma in the second half of this year.”

Recent Business Highlights and Upcoming Milestones:

  • First Patient was dosed in Phase 1 Clinical Trial of AL102 in Combination with Novartis’ BCMA Targeting Agent, WVT087 for the Treatment of Relapsed/Refractory Multiple Myeloma: In April 2021, Ayala announced that the first patient was dosed in its Phase 1 combination trial of AL102 with Novartis’ investigational anti-B-cell maturation antigen (BCMA) agent, WVT078, for the treatment of relapsed and/or refractory multiple myeloma (MM).

  • Completed $25 million Strategic Financing: In February 2021, Ayala announced a $25 million strategic financing with investors including Redmile Group and SIO Capital Management, extending its cash runway into 2023.

  • Phase 2 TENACITY Clinical Trial Continues to Progress: In January 2021, Ayala announced the dosing of the first patient in the Phase 2 TENACITY clinical trial of its potent, selective small molecule, AL101, for the treatment of patients with Notch-activated recurrent or metastatic (R/M) triple negative breast cancer (TNBC). Ayala expects to report preliminary data from this ongoing trial by the end of 2021.

  • Accelerated Development of AL102 for the Treatment of Desmoid Tumors with Pivotal Trial; First site opened in the US for the Phase 2/3 RINGSIDE Trial: In January 2021, Ayala announced that based on its end-of-Phase 1 meeting with the U.S. Food and Drug Administration (FDA) on AL102 for the treatment of desmoid tumors, and data from AL101 and AL102 Phase 1 studies including durable responses observed in patients with desmoid tumors, the FDA agreed to advance the program into a Phase 2/3 pivotal trial. Ayala expects to initiate the pivotal RINGSIDE clinical trial of AL102 in adult and adolescent patients with desmoid tumors in the first half of 2021. Ayala expects an initial interim data read-out from part A of the study and dose selection by mid-2022 with part B of the study commencing immediately thereafter.
  • On Track to Report Additional ACCURACY Phase 2 Data; Patient Enrollment in 6mg Cohort of Phase 2 ACCURACY Study Ongoing: Ayala continues to enroll patients in the 6mg cohort of the Phase 2 ACCURACY study of AL101 for the treatment of recurrent/metastatic adenoid cystic carcinoma (R/M ACC), which will include up to 42 subjects. Further trial progress updates, including additional data, are expected in the second half of 2021.

First Quarter 2021 Financial Results

  • Cash Position: Cash and cash equivalents totaled $56.0 million as of March 31, 2021.
  • Collaboration Revenue: Collaboration revenue was $1.0 million for the first quarter of 2021 and 2020.
  • R&D Expenses: Research and development expenses were $6.9 million for the first quarter of 2021, compared to $5.1 million for the same period in 2020. The increase was primarily driven by additional costs in connection with the advancement of the Desmoids, TNBC and ACC clinical trials.
  • G&A Expenses: General and administrative expenses were $2.3 million for the first quarter of 2021, compared to $1.3 million for the same period in 2020. This increase was primarily due to higher expenses in connection with becoming a public company, including director and officers insurance and stock-based compensation.
  • Net Loss: Net loss was $9.6 million for the first quarter of 2021, resulting in a basic and diluted net loss per share of $0.74. Net loss was $6.6 million for the same period in 2020, resulting in a basic and diluted net loss per share of $1.32.

Financial Guidance

Ayala expects its existing cash balance to fund operating expenses and capital expenditure requirements through multiple potential key clinical and development milestones into 2023.

About Ayala Pharmaceuticals

Ayala Pharmaceuticals, Inc. is a clinical-stage oncology company focused on developing and commercializing small molecule therapeutics for patients suffering from rare and aggressive cancers, primarily in genetically defined patient populations. Ayala’s approach is focused on predicating, identifying and addressing tumorigenic drivers of cancer through a combination of its bioinformatics platform and next-generation sequencing to deliver targeted therapies to underserved patient populations. The company has two product candidates under development, AL101 and AL102, targeting the aberrant activation of the Notch pathway with gamma secretase inhibitors to treat a variety of tumors including Adenoid Cystic Carcinoma, Triple Negative Breast Cancer (TNBC), T-cell Acute Lymphoblastic Leukemia (T-ALL), Desmoid Tumors and Multiple Myeloma (MM) (in collaboration with Novartis). AL101, has received Fast Track Designation and Orphan Drug Designation from the U.S. FDA and is currently in a Phase 2 clinical trial for patients with ACC (ACCURACY) bearing Notch activating mutations and in a Phase 2 clinical trial for patients with TNBC (TENACITY) bearing Notch activating mutations and other gene rearrangements. AL102 is currently being advanced to a Phase 2/3 clinical trials for patients with desmoid tumors (RINGSIDE) and is being evaluated in a Phase 1 clinical trial in combination with Novartis’ BMCA targeting agent, WVT078, in Patients with relapsed/refractory Multiple Myeloma. For more information, visit www.ayalapharma.com.

Contacts:

Investors:
Julie Seidel
Stern Investor Relations, Inc.
+1-212-362-1200
Julie.seidel@sternir.com

Ayala Pharmaceuticals:
+1-857-444-0553
info@ayalapharma.com

Forward-Looking Statements

This press release contains forward-looking statements within the meaning of the Private Securities Litigation Reform Act of 1995. All statements contained in this press release that do not relate to matters of historical fact should be considered forward-looking statements, including statements relating to our development of AL101 and AL102, the promise and potential impact of our preclinical or clinical trial data, the timing of and plans to initiate additional clinical trials of AL101 and AL102, upcoming milestones, including without limitation the timing and results of any clinical trials or readouts, patient enrollment and the sufficiency of cash to fund operations. These forward-looking statements are based on management’s current expectations. The words “may,” “will,” “should,” “expect,” “plan,” “anticipate,” “could,” “intend,” “target,” “project,” “estimate,” “believe,” “predict,” “potential” or “continue” or the negative of these terms or other similar expressions are intended to identify forward-looking statements, although not all forward-looking statements contain these identifying words. These statements are neither promises nor guarantees, but involve known and unknown risks, uncertainties and other important factors that may cause our actual results, performance or achievements to be materially different from any future results, performance or achievements expressed or implied by the forward-looking statements, including, but not limited to, the following: the impact of the COVID-19 pandemic on our operations, including our preclinical studies and clinical trials, and the continuity of our business; we have incurred significant losses, are not currently profitable and may never become profitable; our need for additional funding; our cash runway; our limited operating history and the prospects for our future viability; the lengthy, expensive, and uncertain process of clinical drug development, including potential delays in regulatory approval; our requirement to pay significant payments under product candidate licenses; the approach we are taking to discover and develop product candidates and whether it will lead to marketable products; the expense, time-consuming nature and uncertainty of clinical trials; enrollment and retention of patients; potential side effects of our product candidates; our ability to develop or to collaborate with others to develop appropriate diagnostic tests; protection of our proprietary technology and the confidentiality of our trade secrets; potential lawsuits for, or claims of, infringement of third-party intellectual property or challenges to the ownership of our intellectual property; risks associated with international operations; our ability to retain key personnel and to manage our growth; the potential volatility of our common stock; costs and resources of operating as a public company; unfavorable or no analyst research or reports; and securities class action litigation against us. These and other important factors discussed under the caption “Risk Factors” in our Annual Report on Form 10-K for the year ended December 31, 2020 filed with the U.S. Securities and Exchange Commission (SEC) on March 24, 2021 and our other filings with the SEC could cause actual results to differ materially from those indicated by the forward-looking statements made in this press release. Any such forward-looking statements represent management’s estimates as of the date of this press release. New risk factors and uncertainties may emerge from time to time, and it is not possible to predict all risk factors and uncertainties. While we may elect to update such forward-looking statements at some point in the future, except as required by law, we disclaim any obligation to do so, even if subsequent events cause our views to change. Although we believe the expectations reflected in such forward-looking statements are reasonable, we can give no assurance that such expectations will prove to be correct. These forward-looking statements should not be relied upon as representing our views as of any date subsequent to the date of this press release.

 
AYALA PHARMACEUTICALS, INC.
CONDENSED CONSOLIDATED BALANCE SHEETS
(In thousands, except share and per share amounts)
 
  March 31,
  December 31
   2021    2020  
  (Unaudited)        
CURRENT ASSETS:            
Cash and Cash Equivalents $ 56,030   $ 42,025  
Short-term Restricted Bank Deposits   117     90  
Trade Receivables   169     681  
Prepaid Expenses and other Current Assets   1,534     1,444  
Total Current Assets   57,850     44,240  
LONG-TERM ASSETS:            
Other Assets $ 264   $ 305  
Property and Equipment, Net   1,119     1,283  
Total Long-Term Assets   1,383     1,588  
Total Assets $ 59,233   $ 45,828  
LIABILITIES, CONVERTIBLE PREFERRED STOCK, AND STOCKHOLDERS’ EQUITY:            
CURRENT LIABILITIES:            
Trade Payables $ 3,004   $ 3,726  
Other Accounts Payables   2,690     3,151  
Total Current Liabilities   5,694     6,877  
LONG TERM LIABILITIES:            
Long-term Rent Liability   505     553  
Total Long-Term Liabilities $ 505   $ 553  
STOCKHOLDERS’ DEFICIT:            
Common Stock of $0.01 par value per share; 200,000,000 shares authorized at March 31, 2021 and December 31,            
2020; 13,240,961 and 12,824,463 shares issued at March 31, 2021 and, respectively December 31, 2020;            
13,072,213 and 12,728,446 shares outstanding at March 31, 2021 and December 31, 2020, respectively $ 131   $ 128  
Additional Paid-in Capital   133,358     109,157  
Accumulated Deficit   (80,455 )   (70,887 )
Total Stockholders’ Equity   53,034     38,398  
Total Liabilities, Convertible Preferred Stock, and Stockholders’ Equity $ 59,233   $ 45,828  


 
AYALA PHARMACEUTICALS, INC.
CONDENSED CONSOLIDATED STATEMENTS OF OPERATIONS
(Unaudited)
(In thousands, except share & per share amounts)
 
    For the Three Months Ended
    March 31,
    2021       2020  
Revenues from licensing agreement $ 974     $ 1,001  
Cost of Revenues   (974 )     (1,001 )
Gross profit          
Operating expenses:              
Research and development   6,925       5,128  
General and administrative   2,303       1,311  
Operating loss   (9,228 )     (6,439 )
Financial loss, net   (92 )     (38 )
Loss before income tax   (9,320 )     (6,477 )
Taxes on income   (248 )     (121 )
Net loss attributable to common stockholders   (9,568 )     (6,598 )
Net Loss per share attributable to common stockholders, basic and diluted $ (0.74 )   $ (1.32 )
Weighted average common shares outstanding, basic and diluted   12,888,340       4,999,563  
           

Release – Ayala Pharmaceuticals (AYLA) – Reports First Quarter 2021 Financial Results and Provides Business Update


Ayala Pharmaceuticals Reports First Quarter 2021 Financial Results and Provides Business Update

 

        – First Patient Dosed in Phase 1 AL102 Combination Trial with Novartis’ Anti-BCMA Agent for the Treatment of Multiple Myeloma –

– On Track to Initiate AL102 Phase 2/3 Pivotal Trial for the Treatment of Desmoid Tumors in 1H21-

– Multiple Near-Term Milestones Expected Across Clinical-Stage Pipeline –

REHOVOT, Israel and WILMINGTON, Del., May 14, 2021 (GLOBE NEWSWIRE) — Ayala Pharmaceuticals, Inc. (Nasdaq: AYLA), a clinical-stage oncology company focused on developing and commercializing small molecule therapeutics for patients suffering from rare and aggressive cancers, primarily in genetically defined patient populations, today reported financial results for the first quarter ended March 31, 2021 and highlighted recent progress and upcoming milestones for its pipeline programs.

“Continuing on the strong momentum set in 2020, we are pleased with our progress through the first quarter of 2021. With a strengthened balance sheet and extended cash runway into 2023, we are well positioned to further progress our innovative pipeline of assets targeting the inhibition of gamma secretase through key pathways implicated in rare and aggressive cancers, including adenoid cystic carcinoma, multiple myeloma, triple negative breast cancer and desmoid tumors,” said Roni Mamluk, Ph.D., Chief Executive Officer of Ayala. “We have made great strides to advance our pipeline programs in 2021 with the first patients dosed in both the Phase 2 TENACITY trial in triple negative breast cancer and the Phase 1 combination trial with Novartis in multiple myeloma. We also remain on track to report additional data from the 6mg cohort of our Phase 2 ACCURACY trial of AL101 for the treatment of adenoid cystic carcinoma in the second half of this year.”

Recent Business Highlights and Upcoming Milestones:

  • First Patient was dosed in Phase 1 Clinical Trial of AL102 in Combination with Novartis’ BCMA Targeting Agent, WVT087 for the Treatment of Relapsed/Refractory Multiple Myeloma: In April 2021, Ayala announced that the first patient was dosed in its Phase 1 combination trial of AL102 with Novartis’ investigational anti-B-cell maturation antigen (BCMA) agent, WVT078, for the treatment of relapsed and/or refractory multiple myeloma (MM).

  • Completed $25 million Strategic Financing: In February 2021, Ayala announced a $25 million strategic financing with investors including Redmile Group and SIO Capital Management, extending its cash runway into 2023.

  • Phase 2 TENACITY Clinical Trial Continues to Progress: In January 2021, Ayala announced the dosing of the first patient in the Phase 2 TENACITY clinical trial of its potent, selective small molecule, AL101, for the treatment of patients with Notch-activated recurrent or metastatic (R/M) triple negative breast cancer (TNBC). Ayala expects to report preliminary data from this ongoing trial by the end of 2021.

  • Accelerated Development of AL102 for the Treatment of Desmoid Tumors with Pivotal Trial; First site opened in the US for the Phase 2/3 RINGSIDE Trial: In January 2021, Ayala announced that based on its end-of-Phase 1 meeting with the U.S. Food and Drug Administration (FDA) on AL102 for the treatment of desmoid tumors, and data from AL101 and AL102 Phase 1 studies including durable responses observed in patients with desmoid tumors, the FDA agreed to advance the program into a Phase 2/3 pivotal trial. Ayala expects to initiate the pivotal RINGSIDE clinical trial of AL102 in adult and adolescent patients with desmoid tumors in the first half of 2021. Ayala expects an initial interim data read-out from part A of the study and dose selection by mid-2022 with part B of the study commencing immediately thereafter.
  • On Track to Report Additional ACCURACY Phase 2 Data; Patient Enrollment in 6mg Cohort of Phase 2 ACCURACY Study Ongoing: Ayala continues to enroll patients in the 6mg cohort of the Phase 2 ACCURACY study of AL101 for the treatment of recurrent/metastatic adenoid cystic carcinoma (R/M ACC), which will include up to 42 subjects. Further trial progress updates, including additional data, are expected in the second half of 2021.

First Quarter 2021 Financial Results

  • Cash Position: Cash and cash equivalents totaled $56.0 million as of March 31, 2021.
  • Collaboration Revenue: Collaboration revenue was $1.0 million for the first quarter of 2021 and 2020.
  • R&D Expenses: Research and development expenses were $6.9 million for the first quarter of 2021, compared to $5.1 million for the same period in 2020. The increase was primarily driven by additional costs in connection with the advancement of the Desmoids, TNBC and ACC clinical trials.
  • G&A Expenses: General and administrative expenses were $2.3 million for the first quarter of 2021, compared to $1.3 million for the same period in 2020. This increase was primarily due to higher expenses in connection with becoming a public company, including director and officers insurance and stock-based compensation.
  • Net Loss: Net loss was $9.6 million for the first quarter of 2021, resulting in a basic and diluted net loss per share of $0.74. Net loss was $6.6 million for the same period in 2020, resulting in a basic and diluted net loss per share of $1.32.

Financial Guidance

Ayala expects its existing cash balance to fund operating expenses and capital expenditure requirements through multiple potential key clinical and development milestones into 2023.

About Ayala Pharmaceuticals

Ayala Pharmaceuticals, Inc. is a clinical-stage oncology company focused on developing and commercializing small molecule therapeutics for patients suffering from rare and aggressive cancers, primarily in genetically defined patient populations. Ayala’s approach is focused on predicating, identifying and addressing tumorigenic drivers of cancer through a combination of its bioinformatics platform and next-generation sequencing to deliver targeted therapies to underserved patient populations. The company has two product candidates under development, AL101 and AL102, targeting the aberrant activation of the Notch pathway with gamma secretase inhibitors to treat a variety of tumors including Adenoid Cystic Carcinoma, Triple Negative Breast Cancer (TNBC), T-cell Acute Lymphoblastic Leukemia (T-ALL), Desmoid Tumors and Multiple Myeloma (MM) (in collaboration with Novartis). AL101, has received Fast Track Designation and Orphan Drug Designation from the U.S. FDA and is currently in a Phase 2 clinical trial for patients with ACC (ACCURACY) bearing Notch activating mutations and in a Phase 2 clinical trial for patients with TNBC (TENACITY) bearing Notch activating mutations and other gene rearrangements. AL102 is currently being advanced to a Phase 2/3 clinical trials for patients with desmoid tumors (RINGSIDE) and is being evaluated in a Phase 1 clinical trial in combination with Novartis’ BMCA targeting agent, WVT078, in Patients with relapsed/refractory Multiple Myeloma. For more information, visit www.ayalapharma.com.

Contacts:

Investors:
Julie Seidel
Stern Investor Relations, Inc.
+1-212-362-1200
Julie.seidel@sternir.com

Ayala Pharmaceuticals:
+1-857-444-0553
info@ayalapharma.com

Forward-Looking Statements

This press release contains forward-looking statements within the meaning of the Private Securities Litigation Reform Act of 1995. All statements contained in this press release that do not relate to matters of historical fact should be considered forward-looking statements, including statements relating to our development of AL101 and AL102, the promise and potential impact of our preclinical or clinical trial data, the timing of and plans to initiate additional clinical trials of AL101 and AL102, upcoming milestones, including without limitation the timing and results of any clinical trials or readouts, patient enrollment and the sufficiency of cash to fund operations. These forward-looking statements are based on management’s current expectations. The words “may,” “will,” “should,” “expect,” “plan,” “anticipate,” “could,” “intend,” “target,” “project,” “estimate,” “believe,” “predict,” “potential” or “continue” or the negative of these terms or other similar expressions are intended to identify forward-looking statements, although not all forward-looking statements contain these identifying words. These statements are neither promises nor guarantees, but involve known and unknown risks, uncertainties and other important factors that may cause our actual results, performance or achievements to be materially different from any future results, performance or achievements expressed or implied by the forward-looking statements, including, but not limited to, the following: the impact of the COVID-19 pandemic on our operations, including our preclinical studies and clinical trials, and the continuity of our business; we have incurred significant losses, are not currently profitable and may never become profitable; our need for additional funding; our cash runway; our limited operating history and the prospects for our future viability; the lengthy, expensive, and uncertain process of clinical drug development, including potential delays in regulatory approval; our requirement to pay significant payments under product candidate licenses; the approach we are taking to discover and develop product candidates and whether it will lead to marketable products; the expense, time-consuming nature and uncertainty of clinical trials; enrollment and retention of patients; potential side effects of our product candidates; our ability to develop or to collaborate with others to develop appropriate diagnostic tests; protection of our proprietary technology and the confidentiality of our trade secrets; potential lawsuits for, or claims of, infringement of third-party intellectual property or challenges to the ownership of our intellectual property; risks associated with international operations; our ability to retain key personnel and to manage our growth; the potential volatility of our common stock; costs and resources of operating as a public company; unfavorable or no analyst research or reports; and securities class action litigation against us. These and other important factors discussed under the caption “Risk Factors” in our Annual Report on Form 10-K for the year ended December 31, 2020 filed with the U.S. Securities and Exchange Commission (SEC) on March 24, 2021 and our other filings with the SEC could cause actual results to differ materially from those indicated by the forward-looking statements made in this press release. Any such forward-looking statements represent management’s estimates as of the date of this press release. New risk factors and uncertainties may emerge from time to time, and it is not possible to predict all risk factors and uncertainties. While we may elect to update such forward-looking statements at some point in the future, except as required by law, we disclaim any obligation to do so, even if subsequent events cause our views to change. Although we believe the expectations reflected in such forward-looking statements are reasonable, we can give no assurance that such expectations will prove to be correct. These forward-looking statements should not be relied upon as representing our views as of any date subsequent to the date of this press release.

 
AYALA PHARMACEUTICALS, INC.
CONDENSED CONSOLIDATED BALANCE SHEETS
(In thousands, except share and per share amounts)
 
  March 31,
  December 31
   2021    2020  
  (Unaudited)        
CURRENT ASSETS:            
Cash and Cash Equivalents $ 56,030   $ 42,025  
Short-term Restricted Bank Deposits   117     90  
Trade Receivables   169     681  
Prepaid Expenses and other Current Assets   1,534     1,444  
Total Current Assets   57,850     44,240  
LONG-TERM ASSETS:            
Other Assets $ 264   $ 305  
Property and Equipment, Net   1,119     1,283  
Total Long-Term Assets   1,383     1,588  
Total Assets $ 59,233   $ 45,828  
LIABILITIES, CONVERTIBLE PREFERRED STOCK, AND STOCKHOLDERS’ EQUITY:            
CURRENT LIABILITIES:            
Trade Payables $ 3,004   $ 3,726  
Other Accounts Payables   2,690     3,151  
Total Current Liabilities   5,694     6,877  
LONG TERM LIABILITIES:            
Long-term Rent Liability   505     553  
Total Long-Term Liabilities $ 505   $ 553  
STOCKHOLDERS’ DEFICIT:            
Common Stock of $0.01 par value per share; 200,000,000 shares authorized at March 31, 2021 and December 31,            
2020; 13,240,961 and 12,824,463 shares issued at March 31, 2021 and, respectively December 31, 2020;            
13,072,213 and 12,728,446 shares outstanding at March 31, 2021 and December 31, 2020, respectively $ 131   $ 128  
Additional Paid-in Capital   133,358     109,157  
Accumulated Deficit   (80,455 )   (70,887 )
Total Stockholders’ Equity   53,034     38,398  
Total Liabilities, Convertible Preferred Stock, and Stockholders’ Equity $ 59,233   $ 45,828  


 
AYALA PHARMACEUTICALS, INC.
CONDENSED CONSOLIDATED STATEMENTS OF OPERATIONS
(Unaudited)
(In thousands, except share & per share amounts)
 
    For the Three Months Ended
    March 31,
    2021       2020  
Revenues from licensing agreement $ 974     $ 1,001  
Cost of Revenues   (974 )     (1,001 )
Gross profit          
Operating expenses:              
Research and development   6,925       5,128  
General and administrative   2,303       1,311  
Operating loss   (9,228 )     (6,439 )
Financial loss, net   (92 )     (38 )
Loss before income tax   (9,320 )     (6,477 )
Taxes on income   (248 )     (121 )
Net loss attributable to common stockholders   (9,568 )     (6,598 )
Net Loss per share attributable to common stockholders, basic and diluted $ (0.74 )   $ (1.32 )
Weighted average common shares outstanding, basic and diluted   12,888,340       4,999,563