EX-99.1 2 d439428dex991.htm EX-99.1 EX-99.1

Exhibit 99.1

 

LOGO

Nuvation Bio Reports Third Quarter 2021 Financial Results and Provides Business Update

Enrollment ongoing in phase 1/2 study of NUV-422 for the treatment of multiple difficult-to-treat cancers

Strong balance sheet with cash, cash equivalents and marketable securities of $791.8 million as of September 30, 2021

New York, Nov. 10, 2021 – Nuvation Bio Inc. (NYSE: NUVB), a biopharmaceutical company tackling some of the greatest unmet needs in oncology by developing differentiated and novel therapeutic candidates, today reported financial results for the third quarter ended September 30, 2021, and provided a business update.

“In the third quarter, Nuvation Bio continued to advance our lead cyclin-dependent kinase (CDK) 2/4/6 inhibitor program, with enrollment progressing in the ongoing Phase 1/2 study of NUV-422 for the treatment of adult patients with recurrent glioblastoma, malignant gliomas, hormone receptor-positive breast cancer and metastatic castration-resistant prostate cancer. We remain on track to report top-line data from the Phase 1 portion of the study in 2022,” said David Hung, M.D., founder and chief executive officer of Nuvation Bio. “Additionally, we remain well capitalized to advance our full pipeline of novel oncology therapeutic candidates for difficult-to-treat cancers and look forward to providing clinical development updates.”

Recent Business Highlights

 

   

Enrollment ongoing in Phase 1/2 multiple expansion cohort study of NUV-422. During the third quarter of 2021, Nuvation Bio continued to enroll patients in the Phase 1/2 study of NUV-422, a CDK 2/4/6 inhibitor. The Company submitted a protocol amendment to the U.S. Food and Drug Administration (FDA) in the second quarter, expanding the study to include additional cohorts for patients with recurrent glioblastoma, hormone receptor-positive metastatic breast cancer (with and without brain metastases) and metastatic castration-resistant prostate cancer. Enrollment is ongoing and data from the Phase 1 portion of the study is expected in 2022.

Second Quarter Financial Results

As of September 30, 2021, Nuvation Bio had cash, cash equivalents and marketable securities of $791.8 million.

For the three months ended September 30, 2021, research and development expenses were $17.1 million, compared to $8.6 million for the three months ended September 30, 2020. The increase was primarily due to a $5.3 million increase in third-party costs related to research services and manufacturing to advance our current preclinical programs and Phase 1/2 clinical trial, as well as a $3.2 million increase in personnel-related costs driven by an increase in headcount and stock-based compensation.

For the three months ended September 30, 2021, general and administrative expenses were $5.7 million, compared to $2.9 million for the three months ended September 30, 2020. The increase was primarily due to a $1.9 million increase in personnel-related costs driven by an increase in headcount and stock-based compensation, a $1.1 million increase in insurance, a $0.3 million increase in other miscellaneous expenses offset by a $0.4 million decrease in professional fees and a $0.1 million decrease in legal fees.


For the three months ended September 30, 2021, Nuvation Bio reported a net loss of $22.0 million, or $(0.11) per share. This compares to a net loss of $11.0 million, or $(0.12) per share, for the comparable period in 2020.

About Nuvation Bio

Nuvation Bio is a biopharmaceutical company tackling some of the greatest unmet needs in oncology by developing differentiated and novel therapeutic candidates. Nuvation Bio’s proprietary portfolio includes six novel and mechanistically distinct oncology therapeutic product candidates, each targeting some of the most difficult-to-treat types of cancer. Nuvation Bio was founded in 2018 by biopharma industry veteran David Hung, M.D., who previously founded Medivation, Inc., which brought to patients one of the world’s leading prostate cancer medicines. Nuvation Bio has offices in New York and San Francisco. For more information, please visit www.nuvationbio.com.

Forward Looking Statements

Certain statements included in this press release that are not historical facts are forward-looking statements for purposes of the safe harbor provisions under the United States Private Securities Litigation Reform Act of 1995. Forward-looking statements are sometimes accompanied by words such as “believe,” “may,” “will,” “estimate,” “continue,” “anticipate,” “intend,” “expect,” “should,” “would,” “plan,” “predict,” “potential,” “seem,” “seek,” “future,” “outlook” and similar expressions that predict or indicate future events or trends or that are not statements of historical matters. These forward-looking statements include, but are not limited to, statements regarding the expected timing of clinical trial data. These statements are based on various assumptions, whether or not identified in this press release, and on the current expectations of the management team of Nuvation Bio and are not predictions of actual performance. These forward-looking statements are provided for illustrative purposes only and are not intended to serve as, and must not be relied on as, a guarantee, an assurance, a prediction or a definitive statement of fact or probability. Actual events and circumstances are difficult or impossible to predict and will differ from assumptions. Many actual events and circumstances are beyond the control of Nuvation Bio. These forward-looking statements are subject to a number of risks and uncertainties, including those factors discussed in the Quarterly Report on Form 10-Q expected to be filed with the SEC on or about November 11, 2021, under the heading “Risk Factors,” and other documents that Nuvation Bio has filed or will file with the SEC. If any of these risks materialize or Nuvation Bio’s assumptions prove incorrect, actual results could differ materially from the results implied by these forward-looking statements. There may be additional risks that Nuvation Bio does not presently know, or that Nuvation Bio currently believes are immaterial, that could also cause actual results to differ from those contained in the forward-looking statements. In addition, forward-looking statements reflect Nuvation Bio’s expectations, plans or forecasts of future events and views as of the date of this press release. Nuvation Bio anticipates that subsequent events and developments will cause Nuvation Bio’s assessments to change. However, while Nuvation Bio may elect to update these forward-looking statements at some point in the future, Nuvation Bio specifically disclaims any obligation to do so. These forward-looking statements should not be relied upon as representing Nuvation Bio’s assessments of any date subsequent to the date of this press release. Accordingly, undue reliance should not be placed upon the forward-looking statements.


Nuvation Bio Investor Contact:

ir@nuvationbio.com

Nuvation Bio Media Contact:

Argot Partners

Leo Vartorella

leo@argotpartners.com


NUVATION BIO INC. and Subsidiaries

Condensed Balance Sheets

(In thousands, except share and per share data)

 

     September 30,
2021
    December 31,
2020
 

Assets

    

Current assets:

    

Cash and cash equivalents

   $ 344,631     $ 29,755  

Prepaid expenses

     3,014       914  

Marketable securities available-for-sale, at fair value

     447,153       185,997  

Interest receivable on marketable securities

     1,814       1,092  

Deferred financing costs

     —         2,925  
  

 

 

   

 

 

 

Total current assets

     796,612       220,683  

Property and equipment, net

     758       688  

Other assets:

    

Lease security deposit

     421       421  
  

 

 

   

 

 

 

Total assets

   $ 797,791     $  221,792  
  

 

 

   

 

 

 

Liabilities and stockholders’ equity

 

 

Current liabilities:

    

Accounts payable

   $ 5,163     $ 2,171  

Accrued expenses

     8,145       4,380  
  

 

 

   

 

 

 

Total current liabilities

     13,308       6,551  

Warrant liability

     14,936       —    

Deferred rent - non current

     181       157  
  

 

 

   

 

 

 

Total liabilities

     28,425       6,708  
  

 

 

   

 

 

 

Commitments and contingencies (Note 11)

    

Stockholders’ equity

    

Class A and Class B common stock and additional paid in capital, $0.0001 par value per share; 1,060,000,000 shares authorized as of June 30, 2021 (Class A 1,000,000,000, Class B 60,000,000) and 1,174,094,678 shares authorized as of December 31, 2020 (Class A 880,000,000, Class B 294,094,678); 217,776,232 (Class A 216,776,232, Class B 1,000,000) and 149,042,155 (Class A 91,397,142,

    

Class B 57,645,013) issued and outstanding as of September 30, 2021 and December 31, 2020, respectively

     906,647       289,482  

Accumulated deficit

     (137,669     (75,955

Accumulated other comprehensive income

     388       1,557  
  

 

 

   

 

 

 

Total stockholders’ equity

     769,366       215,084  
  

 

 

   

 

 

 

Total liabilities and stockholders’ equity

   $ 797,791     $ 221,792  
  

 

 

   

 

 

 


NUVATION BIO INC. and Subsidiaries

Condensed Statements of Operations and Comprehensive Loss

(In thousands, except per share data)

 

     Three Months Ended September 30,     Nine Months Ended September 30,  
     2021     2020     2021     2020  

Operating expenses:

        

Research and development

   $ 17,122     $ 8,627     $ 47,035     $ 23,267  

General and administrative

     5,669       2,919       16,674       6,516  
  

 

 

   

 

 

   

 

 

   

 

 

 

Total operating expenses

     22,791       11,546       63,709       29,783  
  

 

 

   

 

 

   

 

 

   

 

 

 

Loss from operations

     (22,791     (11,546     (63,709     (29,783
  

 

 

   

 

 

   

 

 

   

 

 

 

Other income (expense):

        

Interest income

     847       445       2,061       1,486  

Investment advisory fees

     (170     (52     (454     (168

Change in fair value of warrant liability

     125       —         332       —    

Realized gain (loss) on marketable securities

     10       119       56       86  
  

 

 

   

 

 

   

 

 

   

 

 

 

Total other (expense) income

     812       512       1,995       1,404  
  

 

 

   

 

 

   

 

 

   

 

 

 

Loss before income taxes

     (21,979     (11,034     (61,714     (28,379

Provision for income taxes

     —         —         —         —    
  

 

 

   

 

 

   

 

 

   

 

 

 

Net loss

   $  (21,979   $  (11,034   $  (61,714   $  (28,379
  

 

 

   

 

 

   

 

 

   

 

 

 

Net loss attributable to common stockholders

        

Net loss per share attributable to common stockholders, basic and diluted

   $ (0.11   $ (0.12   $ (0.32   $ (0.32
  

 

 

   

 

 

   

 

 

   

 

 

 

Weighted average common shares outstanding, basic and diluted

     207,101       91,771       193,730       88,755  
  

 

 

   

 

 

   

 

 

   

 

 

 

Comprehensive loss:

        

Net loss

   $  (21,979   $  (11,034   $  (61,714   $  (28,379

Other comprehensive income, net of taxes:

        

Change in unrealized (loss) gain on available-for-sale securities

     (369     (350     (1,169     1,400  
  

 

 

   

 

 

   

 

 

   

 

 

 

Comprehensive loss

   $  (22,348   $  (11,384   $  (62,883   $  (26,979