false 0001811063 0001811063 2024-05-14 2024-05-14 0001811063 us-gaap:CommonStockMember 2024-05-14 2024-05-14 0001811063 us-gaap:WarrantMember 2024-05-14 2024-05-14

 

 

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): May 14, 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 May 14, 2024, Nuvation Bio Inc. issued a press release announcing its financial results for the quarter ended March 31, 2024. 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 May 14, 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: May 14, 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 First Quarter 2024 Financial Results and Provides Business Update

Acquisition of AnHeart Therapeutics transformed Nuvation Bio into a late-stage, global oncology company with potential to become a commercial organization by the end of 2025

Updated data from the pivotal Phase 2 TRUST-I clinical study of taletrectinib, a ROS1 inhibitor, to be presented at the 2024 American Society of Clinical Oncology (ASCO) Annual Meeting

First patient treated in a Phase 1/2 study of NUV-1511, the company’s first drug-drug conjugate (DDC) to enter the clinic, for the treatment of various advanced solid tumors

Strong balance sheet with cash, cash equivalents, and marketable securities of $597.0 million as of March 31, 2024

New York, May 14, 2024 – Nuvation Bio Inc. (NYSE: NUVB), a late-stage, global biopharmaceutical company tackling some of the greatest unmet needs in oncology by developing differentiated and novel therapeutic candidates, today reported financial results for the first quarter ended March 31, 2024, and provided a business update.

“The first quarter of 2024 included multiple significant events for Nuvation Bio. We announced and subsequently completed the acquisition of AnHeart Therapeutics, which transformed Nuvation Bio into a late-stage, global company developing multiple clinical programs for some of the most difficult-to-treat cancers. We also treated the first patient in a Phase 1/2 study of NUV-1511, our first DDC to enter the clinic,” said David Hung, M.D., Founder, President, and Chief Executive Officer of Nuvation Bio. “With our robust cash balance and the recent appointment of Colleen Sjogren as our Chief Commercial Officer, along with some new key hires and the integration of new colleagues from AnHeart, we are thoughtfully scaling our organization to execute on our goal of potentially becoming a commercial organization by the end of 2025, while continuing to advance multiple internal programs in various stages of preclinical and clinical development.”

Recent Pipeline Updates:

Taletrectinib, ROS1 inhibitor: Advanced ROS1-positive non-small cell lung cancer (NSCLC)

 

   

Taletrectinib is being evaluated for the treatment of patients with advanced ROS1-positive NSCLC in two Phase 2 single-arm pivotal studies: TRUST-I in China, and TRUST-II, a global study.

 

   

Updated data from the Phase 2 TRUST-I clinical study (NCT04395677) evaluating taletrectinib in patients in China with advanced ROS1-positive NSCLC will be reported in an oral presentation (abstract #8520) at the 2024 ASCO Annual Meeting on Saturday, June 1, 2024, at 4:30-6:30 p.m. CT/5:30-7:30 p.m. ET.

Safusidenib, mIDH1 inhibitor: Grades 2 and 3 IDH1-mutant glioma

 

   

Safusidenib is being evaluated in a global Phase 2 study for the treatment of patients with grades 2 and 3 IDH1-mutant glioma.


NUV-868, BD2-selective BET inhibitor: Advanced solid tumors

 

   

NUV-868 is being evaluated in a Phase 1b dose escalation study in combination with olaparib for the treatment of 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 for the treatment of patients with mCRPC.

NUV-1511, DDC: Advanced solid tumors

 

   

NUV-1511, the Company’s first clinical-stage DDC, is being evaluated in a Phase 1/2 study for the treatment of patients with advanced solid tumors who previously received and progressed on or after treatment with Enhertu® and/or Trodelvy® per approved U.S. Food and Drug Administration (FDA) labeling, human epidermal growth factor receptor 2-negative (HER2-) metastatic breast cancer, mCRPC, advanced pancreatic cancer, and platinum-resistant ovarian cancer (PROC).

Corporate Updates:

 

   

Announced entry into a definitive agreement to acquire AnHeart Therapeutics in March 2024 and completed the acquisition in April 2024.

 

   

Appointed Colleen Sjogren as Chief Commercial Officer. Ms. Sjogren will lead Nuvation Bio’s commercial strategy and operations, including marketing, sales, and market access.

First Quarter 2024 Financial Results

As of March 31, 2024, Nuvation Bio had cash, cash equivalents and marketable securities of $597.0 million.

For the three months ended March 31, 2024, research and development expenses were $12.8 million, compared to $18.8 million for the three months ended March 31, 2023. The decrease was primarily due to a $6.7 million decrease in third-party research services and drug manufacturing costs as a result of completing the Phase 1 monotherapy study of NUV-868, offset by a $0.7 million increase in personnel-related costs driven by stock-based compensation and other benefits.

For the three months ended March 31, 2024, general and administrative expenses were $7.3 million, compared to $7.7 million for the three months ended March 31, 2023. The decrease was due to a $0.5 million decrease in professional fees, $0.4 million decrease in insurance, and a $0.2 million decrease in personnel-related costs, offset by a $0.4 million increase in legal fees, a $0.2 million increase in occupancy expense, and a $0.1 million increase in miscellaneous expense.

For the three months ended March 31, 2024, Nuvation Bio reported a net loss of $14.8 million, or $(0.07) per share. This compares to a net loss of $21.7 million, or $(0.10) per share, for the comparable period in 2023.

About Nuvation Bio

Nuvation Bio is a late-stage, global biopharmaceutical company tackling some of the greatest unmet needs in oncology by developing differentiated and novel therapeutic candidates. Nuvation Bio’s portfolio of development candidates includes taletrectinib (ROS1), safusidenib (mIDH1), NUV-868 (BET), and NUV-1511 (DDC). 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, San Francisco, and Shanghai. For more information, please visit www.nuvationbio.com and https://www.linkedin.com/company/nuvationbio/.


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, the expected timing of becoming a commercial organization, the potential therapeutic benefit of Nuvation Bio’s product candidates, the potential of the DDC platform, the advancement of our preclinical and clinical programs, and the strength of Nuvation Bio’s balance sheet. 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 studies 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-Q filed with the SEC on May 14, 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

Condensed Balance Sheets

Unaudited

 

(In thousands, except share and per share data)

   March 31,
2024
    December 31,
2023
 

Assets

    

Current assets:

    

Cash and cash equivalents

   $ 34,510     $ 42,649  

Prepaid expenses and other current assets

     6,796       1,519  

Marketable securities

     562,466       568,564  

Interest receivable on marketable securities

     4,283       3,702  
  

 

 

   

 

 

 

Total current assets

     608,055       616,434  

Property and equipment, net

     686       717  

Lease security deposit

     141       141  

Operating lease right-of-use assets

     3,168       3,605  

Other non-current assets

     1,075       587  
  

 

 

   

 

 

 

Total assets

   $ 613,125     $ 621,484  
  

 

 

   

 

 

 

Liabilities and stockholders’ equity

    

Current liabilities:

    

Accounts payable

   $ 2,436     $ 2,209  

Current operating lease liabilities

     2,023       1,972  

Accrued expenses

     11,303       9,793  
  

 

 

   

 

 

 

Total current liabilities

     15,762       13,974  

Warrant liability

     1,812       353  

Non-current operating lease liabilities

     1,509       2,035  
  

 

 

   

 

 

 

Total liabilities

     19,083       16,362  
  

 

 

   

 

 

 

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 March 31, 2024 and December 31, 2023, 219,083,219 (Class A 218,083,219, Class B 1,000,000) and 219,046,219 (Class A 218,046,219, Class B 1,000,000) shares issued and outstanding as of March 31, 2023 and December 31, 2022, respectively

     952,807       947,745  

Accumulated deficit

     (357,596     (342,804

Accumulated other comprehensive (loss) income

     (1,169     181  
  

 

 

   

 

 

 

Total stockholders’ equity

     594,042       605,122  
  

 

 

   

 

 

 

Total liabilities and stockholders’ equity

   $ 613,125     $ 621,484  
  

 

 

   

 

 

 


NUVATION BIO INC. and Subsidiaries

Condensed Statements of Operations and Comprehensive Loss

(In thousands, except per share data)

 

For The Three Months Ended March 31,

   2024     2023  

Operating expenses:

    

Research and development

   $ 12,842     $ 18,787  

General and administrative

     7,357       7,734  
  

 

 

   

 

 

 

Total operating expenses

     20,199       26,521  
  

 

 

   

 

 

 

Loss from operations

     (20,199     (26,521
  

 

 

   

 

 

 

Other income (expense):

    

Interest income

     7,130       4,979  

Investment advisory fees

     (265     (230

Change in fair value of warrant liability

     (1,459     142  

Net gain (loss) on marketable securities

     1       (96
  

 

 

   

 

 

 

Total other income (expense), net

     5,407       4,795  
  

 

 

   

 

 

 

Loss before income taxes

     (14,792     (21,726

Provision for income taxes

     —        —   
  

 

 

   

 

 

 

Net loss

   $ (14,792   $ (21,726
  

 

 

   

 

 

 

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

   $ (0.07   $ (0.10
  

 

 

   

 

 

 

Weighted average common shares outstanding, basic and diluted

     219,048       218,741  
  

 

 

   

 

 

 

Comprehensive loss:

    

Net loss

   $ (14,792   $ (21,726

Other comprehensive loss, net of taxes:

    

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

     (1,350     2,588  
  

 

 

   

 

 

 

Comprehensive loss

   $ (16,142   $ (19,138
  

 

 

   

 

 

 
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May 14, 2024
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Entity Central Index Key 0001811063
Document Type 8-K
Document Period End Date May 14, 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
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Trading Symbol NUVB
Security Exchange Name NYSE
Warrant [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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