false 0001811063 0001811063 2024-02-29 2024-02-29 0001811063 us-gaap:CommonStockMember 2024-02-29 2024-02-29 0001811063 nuvb:RedeemableWarrantsEachWholeWarrantExercisableForOneShareOfCommonStockAtAnExercisePriceOf11.50PerShareMember 2024-02-29 2024-02-29

 

 

UNITED STATES

SECURITIES AND EXCHANGE COMMISSION

Washington, D.C. 20549

 

 

FORM 8-K

 

 

CURRENT REPORT

Pursuant to Section 13 or 15(d)

of the Securities Exchange Act of 1934

Date of Report (Date of earliest event reported): February 29, 2024

 

 

Nuvation Bio Inc.

(Exact name of registrant as specified in its charter)

 

 

 

Delaware   001-39351   85-0862255

(State or other jurisdiction

of incorporation)

 

(Commission

File Number)

 

(I.R.S. Employer

Identification No.)

1500 Broadway, Suite 1401

New York, NY 10036

(Address of principal executive offices)

(332) 208-6102

(Registrant’s telephone number, including area code)

 

 

Check the appropriate box below if the Form 8-K filing is intended to simultaneously satisfy the filing obligation of the registrant under any of the following provisions:

 

Written communications pursuant to Rule 425 under the Securities Act (17 CFR 230.425)

 

Soliciting material pursuant to Rule 14a-12 under the Exchange Act (17 CFR 240.14a-12)

 

Pre-commencement communications pursuant to Rule 14d-2(b) under the Exchange Act (17 CFR 240.14d-2(b))

 

Pre-commencement communications pursuant to Rule 13e-4(c) under Exchange Act (17 CFR 240.13e-4(c))

Securities registered pursuant to Section 12(b) of the Act:

 

Title of each class

 

Trading

Symbol(s)

 

Name of each exchange

on which registered

Class A Common Stock, $0.0001 par value per share   NUVB   The New York Stock Exchange
Redeemable Warrants, each whole warrant exercisable for one share of Common Stock at an exercise price of $11.50 per share   NUVB.WS   The New York Stock Exchange

Indicate by check mark whether the registrant is an emerging growth company as defined in Rule 405 of the Securities Act of 1933(§230.405 of this chapter) or Rule 12b-2 of the Securities Exchange Act of 1934 (§240.12b-2 of this chapter).

Emerging growth company 

If an emerging growth company, indicate by check mark if the registrant has elected not to use the extended transition period for complying with any new or revised financial accounting standards provided pursuant to Section 13(a) of the Exchange Act. ☐

 

 

 


ITEM 2.02.

RESULTS OF OPERATIONS AND FINANCIAL CONDITION

On February 29, 2024, Nuvation Bio Inc. issued a press release announcing its financial results for the quarter ended December 31, 2023. A copy of the press release is furnished as Exhibit 99.1 to this Form 8-K.

The information contained in this Form 8-K, including in the accompanying Exhibit 99.1, shall not be deemed filed for purposes of Section 18 of the Securities Exchange Act of 1934, as amended, or incorporated by reference in any filing under the Exchange Act or the Securities Act of 1933, as amended, except as shall be expressly set forth by specific reference in such filing.

 

ITEM 9.01

FINANCIAL STATEMENTS AND EXHIBITS

(d) Exhibits.

 

Exhibit
Number
  

Description

99.1    Press Release of Nuvation Bio Inc. dated February 29, 2024.
104    Cover Page Interactive Data File (embedded within XBRL document)

 

2


SIGNATURES

Pursuant to the requirements of the Securities Exchange Act of 1934, as amended, the registrant has duly caused this report to be signed on its behalf by the undersigned hereunto duly authorized.

 

Dated: February 29, 2024

 

NUVATION BIO INC.

 

By:

 

/s/ Moses Makunje

  Name:   Moses Makunje
  Title:   VP, Finance, Principal Financial and Accounting Officer

 

3

Exhibit 99.1

LOGO

Nuvation Bio Reports Fourth Quarter and Full Year 2023 Financial Results and Provides Business Update

Determined maximum tolerated dose (MTD) in Phase 1 monotherapy study of NUV-868; Phase 1b

studies of NUV-868 in combination with olaparib or enzalutamide remain ongoing

Received U.S. Food and Drug Administration (FDA) clearance of Investigational New Drug (IND)

application for NUV-1511, the first clinical candidate from our novel drug-drug conjugate (DDC) platform

Strong balance sheet with cash, cash equivalents and marketable securities of $611.2 million as of December 31, 2023

New York, February 29, 2024 – 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 fourth quarter and full year ended December 31, 2023, and provided a business update.

“We are pleased to announce completion of a Phase 1 monotherapy study of NUV-868 and determination of a MTD that will help inform our ongoing Phase 1b combination studies. As we announced in January, we received FDA clearance of our IND application for NUV-1511 and look forward to initiating a Phase 1/2 study for the first clinical candidate from our DDC platform in the first half of this year,” said David Hung, M.D., Founder, President, and Chief Executive Officer of Nuvation Bio. “Nuvation strongly executed across our pipeline of cancer therapies in 2023 and we plan to build on this progress in 2024 as we remain committed to bringing novel and differentiated therapies to patients with the most difficult-to-treat cancers.”

Recent Business Updates

NUV-868, BD2-Selective BETi: Advanced solid tumors

 

   

Phase 1 monotherapy study is complete. Nuvation Bio has completed the Phase 1 monotherapy study in advanced solid tumors and determined the MTD in patients.

 

   

Phase 1b combination studies remain ongoing. Nuvation Bio continues to conduct the Phase 1b studies of NUV-868 in combination with olaparib in patients with ovarian cancer, pancreatic cancer, metastatic castration-resistant prostate cancer (mCRPC), triple negative breast cancer and other solid tumors, and in combination with enzalutamide in patients with mCRPC.

NUV-1511, Drug-Drug Conjugate Platform: Advanced solid tumors

 

   

IND cleared for first clinical candidate, NUV-1511. Nuvation Bio received IND clearance from the FDA for the treatment of patients with various advanced solid tumors and remains on track to dose the first patient in a Phase 1/2 study of NUV-1511 in the first half of 2024.


Corporate Update:

 

   

Appointed Dr. Robert Mashal to Board of Directors. Dr. Mashal’s experience as a seasoned pharmaceutical executive and medical oncologist will provide valuable insights.

Fourth Quarter and Full Year 2023 Financial Results

As of December 31, 2023, Nuvation Bio had cash, cash equivalents and marketable securities of $611.2 million.

For the three months ended December 31, 2023, research and development expenses were $15.4 million, compared to $16.9 million for the three months ended December 31, 2022. The decrease was primarily due to a $1.7 million decrease in third-party costs related to research services and manufacturing driven by the termination of the NUV-422 program offset by a $0.2 million increase in personnel-related costs. Research and development expenses for the year ended December 31, 2023 were $71.3 million compared to $87.8 million for the year ended December 31, 2022.

For the three months ended December 31, 2023, general and administrative expenses were $5.5 million, compared to $7.4 million for the three months ended December 31, 2022. The decrease was primarily due to a $1.3 million decrease in personnel-related costs, $0.6 million decrease in insurance, a $0.2 million decrease in professional fees, a $0.1 million decrease in taxes and a $0.1 million decrease in miscellaneous expenses offset by $0.2 million increase in legal fees, and a $0.2 million increase in occupancy. General and administrative expenses for the year ended December 31, 2023 were $28.5 million compared to $31.9 million for the year ended December 31, 2022.

For the three months ended December 31, 2023, Nuvation Bio reported a net loss of $13.8 million, or $(0.06) per share. This compares to a net loss of $20.8 million, or $(0.10) per share, for the comparable period in 2022. Net loss for the year ended December 31, 2023 was $75.8 million compared to $104.2 million for the year ended December 31, 2022.

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 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 initiation of a Phase 1/2 study for NUV-1511 in the first half of 2024. 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 subject to a number of risks and uncertainties that may cause actual results to differ from those anticipated by the forward-looking statements, including but not limited to the challenges associated with conducting drug discovery and initiating or conducting clinical trials due to, among other things, difficulties or delays in the regulatory process, enrolling subjects or manufacturing or acquiring necessary products; the emergence or worsening of adverse events or other undesirable side effects; risks associated with preliminary and interim data, which may not be representative of more mature data; and competitive developments. Risks and uncertainties facing Nuvation Bio are described more fully in its Form 10-K to be filed with the SEC on February 29, 2024, under the heading “Risk Factors,” and other documents that Nuvation Bio has filed or will file with the SEC. You are cautioned not to place undue reliance on the forward-looking statements, which speak only as of the date of this press release. Nuvation Bio disclaims any obligation or undertaking to update, supplement or revise any forward-looking statements contained in this press release.

Nuvation Bio Investor Contact:

ir@nuvationbio.com

Nuvation Bio Media Contact:

nuvation@argotpartners.com


NUVATION BIO INC. and Subsidiaries

Consolidated Balance Sheets

(In thousands, except share and per share data)

 

     December 31,  
     2023     2022  

Assets

    

Current assets:

    

Cash and cash equivalents

   $ 42,649     $ 101,099  

Prepaid expenses

     1,519       3,819  

Marketable securities available-for-sale, at fair value

     568,564       559,915  

Interest receivable on marketable securities

     3,702       2,485  
  

 

 

   

 

 

 

Total current assets

     616,434       667,318  

Property and equipment, net

     717       894  

Lease security deposit

     141       138  

Operating lease right-of-use assets

     3,605       3,791  

Other non-current assets

     587       —   
  

 

 

   

 

 

 

Total assets

   $ 621,484     $ 672,141  
  

 

 

   

 

 

 

Liabilities and stockholders’ equity

    

Current liabilities:

    

Accounts payable

   $ 2,209     $ 2,139  

Current operating lease liabilities

     1,972       1,206  

Accrued expenses

     9,793       9,816  
  

 

 

   

 

 

 

Total current liabilities

     13,974       13,161  

Warrant liability

     353       850  

Non-current operating lease liabilities

     2,035       3,054  
  

 

 

   

 

 

 

Total liabilities

     16,362       17,065  
  

 

 

   

 

 

 

Stockholders’ equity

    

Class A and Class B common stock and additional paid in capital, $0.0001 par value per share; 1,060,000,000 (Class A 1,000,000,000, Class B 60,000,000) shares authorized as of December 31, 2023 and December 31, 2022, respectively; 219,046,219 (Class A 218,046,219, Class B 1,000,000) and 218,632,699 (Class A 217,632,699, Class B 1,000,000) issued and outstanding as of December 31, 2023 and 2022, respectively

     947,745       927,604  

Accumulated deficit

     (342,804     (267,002

Accumulated other comprehensive income (loss)

     181       (5,526
  

 

 

   

 

 

 

Total stockholders’ equity

     605,122       655,076  
  

 

 

   

 

 

 

Total liabilities and stockholders’ equity

   $ 621,484     $ 672,141  
  

 

 

   

 

 

 


NUVATION BIO INC. and Subsidiaries

Consolidated Statements of Operations and Comprehensive Loss

(In thousands, except per share data)

 

     Three Months Ended December 31,     Years Ended December 31,  
     2023     2022     2023     2022  

Operating expenses:

        

Research and development

   $ 15,351     $ 16,871     $ 71,289     $ 87,815  

General and administrative

     5,480       7,464       28,533       31,919  
  

 

 

   

 

 

   

 

 

   

 

 

 

Total operating expenses

     20,831       24,335       99,822       119,734  
  

 

 

   

 

 

   

 

 

   

 

 

 

Loss from operations

     (20,831     (24,335     (99,822     (119,734
  

 

 

   

 

 

   

 

 

   

 

 

 

Other income (expense):

        

Interest income

     7,023       3,523       24,611       7,448  

Investment advisory fees

     (260     (225     (949     (872

Change in fair value of warrant liability

     237       321       497       10,187  

Realized gain (loss) on marketable securities

     44       (129     (139     (1,228
  

 

 

   

 

 

   

 

 

   

 

 

 

Total other income (expense), net

     7,044       3,490       24,020       15,535  
  

 

 

   

 

 

   

 

 

   

 

 

 

Loss before income taxes

     (13,787     (20,845     (75,802     (104,199

Provision for income taxes

     —        —        —        —   
  

 

 

   

 

 

   

 

 

   

 

 

 

Net loss

   $ (13,787   $ (20,845   $ (75,802   $ (104,199
  

 

 

   

 

 

   

 

 

   

 

 

 

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

   $ (0.06   $ (0.10   $ (0.35   $ (0.48
  

 

 

   

 

 

   

 

 

   

 

 

 

Weighted average common shares outstanding, basic and diluted

     218,993       218,497       218,880       216,721  
  

 

 

   

 

 

   

 

 

   

 

 

 

Comprehensive loss:

        

Net loss

   $ (13,787   $ (20,845   $ (75,802   $ (104,199

Other comprehensive loss, net of taxes:

        

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

     3,479       2,591       5,707       (4,341
  

 

 

   

 

 

   

 

 

   

 

 

 

Comprehensive loss

   $ (10,308   $ (18,254   $ (70,095   $ (108,540
  

 

 

   

 

 

   

 

 

   

 

 

 
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Document and Entity Information
Feb. 29, 2024
Document And Entity Information [Line Items]  
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Entity Central Index Key 0001811063
Document Type 8-K
Document Period End Date Feb. 29, 2024
Entity Registrant Name Nuvation Bio Inc.
Entity Incorporation State Country Code DE
Entity File Number 001-39351
Entity Tax Identification Number 85-0862255
Entity Address, Address Line One 1500 Broadway
Entity Address, Address Line Two Suite 1401
Entity Address, City or Town New York
Entity Address, State or Province NY
Entity Address, Postal Zip Code 10036
City Area Code (332)
Local Phone Number 208-6102
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Pre Commencement Tender Offer false
Pre Commencement Issuer Tender Offer false
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Common Stock [Member]  
Document And Entity Information [Line Items]  
Security 12b Title Class A Common Stock, $0.0001 par value per share
Trading Symbol NUVB
Security Exchange Name NYSE
Redeemable Warrants Each Whole Warrant Exercisable For One Share Of Common Stock At An Exercise Price Of 11.50 Per Share [Member]  
Document And Entity Information [Line Items]  
Security 12b Title Redeemable Warrants, each whole warrant exercisable for one share of Common Stock at an exercise price of $11.50 per share
Trading Symbol NUVB.WS
Security Exchange Name NYSE

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