Finance

Nuvation Bio Reports Full Year 2020 Financial Results and Provides Business Update

Nuvation Bio Reports Full Year 2020 Financial Results and Provides Business Update

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 its financial results for the year ended December 31, 2020 and provided a business update.

Nuvation Bio began a new chapter as a public company following the successful completion of our business combination with Panacea in February. With a strong cash position of approximately $830 million after transaction fees, as well as a recently expanded leadership team and employees dedicated to meaningfully improving the survival and quality of life for people with cancer, we are confident in our ability to advance our deep pipeline,” said David Hung, M.D., founder and chief executive officer of Nuvation Bio. “Looking ahead, patient recruitment and dosing is ongoing in our Phase 1/2 study of NUV-422 in high-grade gliomas. As we recently announced, NUV-422has received the FDA’s Orphan Drug Designation for the treatment of malignant gliomas. We are also continuing to progress the rest of our portfolio of novel and mechanistically distinct therapies for solid and hematologic cancers. We expect to submit up to five additional Investigational New Drug applications with the U.S. Food and Drug Administration by 2026.”

Recent Business Highlights

  • Debuted as publicly traded oncology company following the closing of a business combination with Panacea Acquisition Corp. In February 2021, Nuvation Bio announced the closing of its business combination with Panacea Acquisition Corp., a SPAC sponsored by EcoR1 Capital, and the commencement of trading shares of the combined company on the New York Stock Exchange (NYSE) under the ticker symbol “NUVB.” Nuvation Bio’s total cash position at closing was approximately $830 million after transaction costs, including approximately $646 million held in Panacea’s trust account and received in concurrent private financings led by EcoR1 Capital, as well as 683 Capital, Ally Bridge Group, Avidity Partners, Deerfield Management Company, Irving Investors, Monashee Investment Management LLC, OrbiMed, Wellington Management and other existing Nuvation Bio shareholders including The Baupost Group, Boxer Capital of the Tavistock Group, Fidelity Management & Research Company, LLC, Omega Funds, Perceptive Advisors, Redmile Group and Surveyor Capital (a Citadel Company).



  • Initiated a Phase 1/2 study of NUV-422, the first of Nuvation’s six compounds to enter the clinic. In December 2020, Nuvation Bio commenced patient enrollment and dosing in the Phase 1/2 study of its lead investigational compound, NUV-422, a cyclin-dependent kinase (CDK) 2/4/6 inhibitor, in adult patients with recurrent or refractory high-grade gliomas, including glioblastoma multiforme (GBM). The Phase 1 dose escalation part of the study is designed to evaluate safety and tolerability, as well as to determine a recommended Phase 2 dose based on the tolerability profile and pharmacokinetic properties of NUV-422. The Phase 2 dose expansion part of the study is expected to initially focus on patients with high-grade gliomas and is designed to evaluate overall response rate, duration of response and survival. Data from the Phase 1 portion of this study is expected in 2022. The U.S. Food and Drug Administration (FDA) in March granted Orphan Drug Designation to NUV-422 for the treatment of malignant gliomas.



  • Expanded executive team with key appointments. In January 2021, Nuvation Bio appointed Lisa DeLuca as senior vice president, regulatory affairs. Ms. DeLuca brings more than 25 years of regulatory experience to Nuvation Bio and most recently led the regulatory team at Radius Health. In October 2020, Nuvation Bio appointed Jennifer Fox as chief financial officer to lead corporate strategy, business development, investor relations and corporate communications. Ms. Fox joined Nuvation Bio from Citigroup, where she most recently served as a managing director and co-head of the Healthcare Corporate and Investment Banking Group.

Full Year 2020 Financial Results

The following financial results for the year ended December 31, 2020 represent Nuvation Bio Inc. (now known as Nuvation Bio Operating Company Inc.) as a standalone private company, as its business combination with Panacea Acquisition Corp. closed on February 10, 2021. The financial results of Panacea Acquisition Corp. for the year ended December 31, 2020 will be reported in the Annual Report on Form 10-K to be filed by Nuvation Bio in March 2021. Nuvation Bio’s financial statements for the first quarter of 2021, to be reported in May 2021, and for subsequent periods will reflect the financial results of the combined public company.

Research and development expense for the year ended December 31, 2020 was $32.6 million compared to $25.1 million for the year ended December 31, 2019. General and administrative expense for 2020 was $10.9 million, compared to $7.0 million for 2019.

Net loss for 2020 was $41.7 million compared to $33.6 million for 2019.

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 potential therapeutic benefit of Nuvation Bio’s product candidates and 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 proxy statement/prospectus filed with the SEC on January 20, 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 INC. and Subsidiaries

 

Consolidated Balance Sheets

(In thousands, except share and per share data)

 
  

December 31,

2020

 

2019

 

Assets

   
    

Current assets:

   

      Cash and cash equivalents

$ 29,755

 

$ 3,469

      Prepaid expenses

914

 

187

      Marketable securities available-for-sale, at fair value

185,997

 

112,893

      Investments to be held to maturity, at cost

 

2,508

      Interest receivable on marketable securities

1,092

 

828

        Deferred financing costs

2,925

 

    

Total current assets

220,683

 

119,885

Property and equipment, net 

688

 

646

Other assets:

   

      Lease security deposit

421

 

421

 

Total assets 

$221,792

 

$120,952

    

Liabilities, redeemable convertible preferred stock, and stockholders’ deficit

   

Current liabilities:

   

      Accounts payable 

$ 2,171

 

$ 2,030

      Accrued expenses

4,380

 

1,163

      Deferred rent

 

11

Total current liabilities

6,551

 

3,204

      Deferred rent – non current 

157

 

Total liabilities

6,708

 

3,204

    

Redeemable Series A convertible preferred stock, $0.0001 par value per share;

   

 

360,500,000 shares authorized; 347,423,117 and 184,501,999 shares issued and outstanding as of December 31, 2020 and December 31, 2019, respectively (liquidation preference of $268 million as of December 31, 2020) 

267,521

 

141,864

    

Stockholders’ deficit

   

Class A and Class B common stock and additional paid in capital, $0.0001 par value per share; 1,174,094,678 shares authorized as of December 31, 2020 (Class A 880,000,000, Class B 294,094,678) and 880,000,000 authorized shares of common stock as of December 31, 2019; 412,963,780 (Class A 118,869,102, Class B 294,094,678) and 400,000,000 shares issued and outstanding as of December 31, 2020 and 2019, respectively

21,961

9,759

    Accumulated deficit 

(75,955)

(34,296)

    Accumulated other comprehensive income

1,557

421

Total stockholders’ deficit 

(52,437)

(24,116)

 

Total liabilities, redeemable convertible preferred stock, and stockholders’ deficit

$221,792

$120,952

NUVATION BIO INC. and Subsidiaries

Consolidated Statements of Operations and Comprehensive Loss

(In thousands, except share and per share data)

    

  For the Years Ended December 31,

2020

 

2019

    
    

Operating expenses:

   

Research and development 

$       32,603

 

$       25,106

General and administrative

10,948

 

6,993

Total operating expenses

43,551

 

32,099

    

Loss from operations

(43,551)

 

(32,099)

    

Other income (expense):

   

Interest income

1,945

 

1,287

Investment advisory fees

(271)

 

(135)

Realized gain on marketable securities

218

 

53

Interest expense

 

(2,658)

Total other income (expense)

1,892

 

(1,453)

    

Loss before income taxes

(41,659)

 

(33,552)

    

Provision for income taxes

 

    

Net loss

$     (41,659)

 

$     (33,552)

Deemed dividend related to beneficial conversion feature and accretion

   

 of discount on Redeemable Series A Convertible Preferred Stock

$     (22,622)

 

Net loss attributable to common stockholders

$     (64,281)

 

$     (33,552)

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

$        (0.23)

 

$        (0.16)

Weighted average common shares outstanding, basic and diluted

277,529,317

 

206,672,024

    

Comprehensive loss:

   

Net loss

$     (41,659)

 

$     (33,552)

Other comprehensive income, net of taxes:

   

Change in unrealized gain on available-for-sale securities

1,136

 

421

    

Comprehensive loss

$     (40,523)

 

$     (33,131)

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