Nuvation Bio Reports Fourth Quarter and Full Year 2024 Financial Results and Provides Business Update

U.S. Food and Drug Administration (FDA) accepted and granted Priority Review to the New Drug Application (NDA) for taletrectinib for advanced ROS1-positive (ROS1+) non-small cell lung cancer (NSCLC); Prescription Drug User Fee Act (PDUFA) goal date of June 23, 2025

Innovent Biologics' commercialization of taletrectinib underway in China after recent line agnostic approval for advanced ROS1+ NSCLC; Nippon Kayaku completed submission of a Marketing Authorization Application $(MAA)$ for taletrectinib in Japan for the same indication

Launched an Expanded Access Program (EAP) in the U.S. for taletrectinib for advanced ROS1+ NSCLC in February 2025

Strong balance sheet with cash, cash equivalents, and marketable securities of $502.7 million as of December 31, 2024

Secured up to $250 million in non-dilutive financings from Sagard Healthcare Partners in March 2025

NEW YORK--(BUSINESS WIRE)--March 06, 2025-- 

Nuvation Bio Inc. $(NUVB)$, a global biopharmaceutical company tackling some of the greatest unmet needs in oncology, today reported financial results for the fourth quarter and full year ended December 31, 2024, and provided a business update.

"Nuvation Bio had a transformative year in 2024, marked by significant milestones. We acquired AnHeart Therapeutics, reported positive pivotal data for taletrectinib, and submitted the NDA for taletrectinib, which was accepted by the U.S. FDA for Priority Review. This sets the stage for a potential U.S. commercial launch following our PDUFA goal date of June 23. We are also proud to now offer an Expanded Access Program in the U.S. for taletrectinib, addressing the urgent needs of patients with advanced ROS1-positive NSCLC," said David Hung, M.D., Founder, President, and Chief Executive Officer of Nuvation Bio. "Beyond taletrectinib, we anticipate further updates in 2025 from our additional pipeline programs, including safusidenib and NUV-1511. With an exceptionally talented team and the closing of our recent non-dilutive financings of up to $250 million, we are well-positioned to continue toward our goal of improving the lives of people with cancer."

Recent Pipeline Updates:

Taletrectinib, ROS1 inhibitor: Advanced ROS1+ NSCLC

   -- In December 2024, the U.S FDA accepted and granted Priority Review to the 
      Company's NDA for taletrectinib for advanced ROS1+ NSCLC (line agnostic, 
      full approval). The PDUFA goal date of June 23, 2025, positions Nuvation 
      Bio to commercialize taletrectinib in the U.S., if approved, in mid-2025. 
 
   -- In January 2025, China's National Medical Products Administration (NMPA) 
      approved taletrectinib for adult patients with locally advanced or 
      metastatic ROS1+ NSCLC. As part of an exclusive license agreement, 
      Innovent Biologics is commercializing taletrectinib in Greater China. 
 
   -- In February 2025, Nuvation Bio launched an EAP in the U.S., enabling 
      eligible patients with advanced ROS1+ NSCLC to access taletrectinib 
      outside of the ongoing pivotal TRUST-II study. 
 
   -- In March 2025, Nippon Kayaku completed submission of a MAA for 
      taletrectinib for advanced ROS1+ NSCLC to Japan's Pharmaceuticals and 
      Medical Devices Agency (PMDA). As part of an exclusive license agreement, 
      Nippon Kayaku will commercialize taletrectinib in Japan. 

Safusidenib, mIDH1 inhibitor: Diffuse IDH1-mutant glioma

   -- Safusidenib is a potentially best-in-class, novel, oral, brain penetrant 
      inhibitor of mutant IDH1. 
 
   -- Phase 2 study in patients with diffuse IDH1-mutant glioma is ongoing. 

NUV-1511, drug-drug conjugate $(DDC)$: Advanced solid tumors

   -- NUV-1511, the Company's first clinical-stage DDC, fuses a targeting agent 
      to a widely used chemotherapy agent. 
 
   -- Phase 1/2 dose escalation study in patients with advanced solid tumors is 
      ongoing. 

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

   -- As previously announced, the Company is evaluating next steps for the 
      NUV-868 program, including external partnership opportunities or further 
      development in combination with approved products for indications in 
      which BD2-selective BET inhibitors may improve outcomes for patients. 

Corporate Update:

   -- In March 2025, Nuvation Bio secured up to $250 million in non-dilutive 
      financings from Sagard Healthcare Partners. The Company will receive $150 
      million in royalty interest financing and $50 million in debt upon U.S. 
      FDA approval of taletrectinib by September 30, 2025, with access to an 
      additional $50 million in debt at the Company's option after first 
      commercial sale. The royalty interest financing is expected to fully fund 
      the U.S. commercial launch of taletrectinib. The Company's pro forma cash 
      balance is expected to fully fund development of the Company's 
      clinical-stage pipeline and create a path to potential profitability 
      without a need for additional fundraising. 

Fourth Quarter and Full Year 2024 Financial Results

As of December 31, 2024, Nuvation Bio had cash, cash equivalents, and marketable securities of $502.7 million.

For the three months ended December 31, 2024, research and development expenses were $29.3 million, compared to $15.4 million for the three months ended December 31, 2023. The increase was due to a $11.7 million increase in personnel-related costs driven by the acquisition of AnHeart Therapeutics, stock-based compensation and other benefits, a $2.1 million increase in third-party costs related to research services and drug manufacturing as a result of clinical trial expense for taletrectinib, and a $0.1 million increase in amortization of assembled workforce.

For the three months ended December 31, 2024, selling, general, and administrative expenses were $26.1 million, compared to $5.5 million for the three months ended December 31, 2023. The increase was due to a $9.5 million increase in personnel-related costs as a result of the acquisition of AnHeart Therapeutics, a $7.8 million increase in sales and marketing expenses, a $1.3 million increase in professional fees, a $1.2 million increase in other expenses as a result of the integration of AnHeart Therapeutics, a $0.7 million increase in foreign currency impact, and a $0.2 million increase in legal fees, offset by a $0.1 million decrease in insurance expense.

For the three months ended December 31, 2024, Nuvation Bio reported a net loss of $49.4 million, or $(0.15) per share. This compares to a net loss of $13.8 million, or $(0.06) per share, for the comparable period in 2023.

About Taletrectinib

Taletrectinib is an oral, potent, central nervous system-active, selective, next-generation ROS1 inhibitor specifically designed for the treatment of patients with advanced ROS1+ NSCLC. Taletrectinib is being evaluated for the treatment of patients with advanced ROS1+ NSCLC in two Phase 2 single-arm pivotal studies: TRUST-I (NCT04395677) in China, and TRUST-II (NCT04919811), a global study.

Based on pooled results of the TRUST-I and TRUST-II clinical studies, the U.S. FDA has accepted and granted Priority Review to Nuvation Bio's NDA for taletrectinib for advanced ROS1+ NSCLC (line agnostic, full approval) and assigned a PDUFA goal date of June 23, 2025. The U.S. FDA previously granted taletrectinib Breakthrough Therapy Designation for the treatment of patients with locally advanced or metastatic ROS1+ NSCLC who either have or have not previously been treated with ROS1 TKIs, and Orphan Drug Designation for the treatment of patients with ROS1+ NSCLC and other NSCLC indications. In January 2025, China's NMPA approved taletrectinib for the treatment of adult patients with locally advanced or metastatic ROS1+ NSCLC.

About Nuvation Bio

Nuvation Bio is a global biopharmaceutical company tackling some of the greatest unmet needs in oncology by developing differentiated and novel product candidates. Nuvation Bio's programs include taletrectinib (ROS1), safusidenib (mIDH1), NUV-1511 (DDC), and NUV-868 $(BET.AU)$. 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, Boston, and Shanghai. For more information, please visit www.nuvationbio.com or follow the Company on LinkedIn and X (@nuvationbioinc).

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, our expectations regarding U.S. FDA approval and commercial launch of taletrectinib, and the timing thereof, receipt and use of proceeds from the Sagard Healthcare Partners financings to fully fund U.S. commercial launch of taletrectinib and development of Nuvation Bio's current clinical-stage pipeline, the path to potential profitability without need to raise additional capital, the potential therapeutic benefit of Nuvation Bio's product candidates, the advancement of our 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-K filed with the SEC on March 6, 2025 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 INC. and Subsidiaries 
 
 Consolidated Balance Sheets 
(In thousands, except share and per share 
data)                                              December 31, 
                                             ------------------------- 
                                                2024         2023 
                                              ---------    -------- 
 
Assets 
Current assets: 
   Cash and cash equivalents                 $   35,723   $  42,649 
   Accounts receivable, net of allowance 
    for credit loss of $nil                      12,722           - 
   Prepaid expenses                               7,271       1,519 
   Marketable securities                        466,969     568,564 
   Interest receivable on marketable 
    securities                                    3,570       3,702 
                                              ---------    -------- 
      Total current assets                      526,255     616,434 
Property and equipment, net of accumulated 
 depreciation of $874 and $666, 
 respectively                                       586         717 
Intangible assets, net of accumulated 
 amortization of $448                             4,622           - 
Lease security deposit                              145         141 
Operating lease right-of-use assets               2,402       3,605 
Other non-current assets                          6,616         587 
                                              ---------    -------- 
      Total assets                           $  540,626   $ 621,484 
                                              =========    ======== 
 
Liabilities and stockholders' equity 
Current liabilities: 
   Accounts payable                          $    6,348   $   2,209 
   Current operating lease liabilities            1,663       1,972 
   Contract liabilities, current portion         11,117           - 
   Short-term borrowings                          6,283           - 
   Accrued expenses                              32,833       9,793 
                                              ---------    -------- 
      Total current liabilities                  58,244      13,974 
Warrant liability                                 2,053         353 
Contract liabilities, net of current 
 portion                                         15,572           - 
Non-current operating lease liabilities             969       2,035 
                                              ---------    -------- 
      Total liabilities                          76,838      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 December 31, 
    2024 and December 31, 2023, 
    respectively; 337,837,872 (Class A 
    336,837,872, Class B 1,000,000) and 
    219,046,219 (Class A 218,046,219, Class 
    B 1,000,000) issued and outstanding as 
    of December 31, 2024 and 2023, 
    respectively                              1,373,958     947,745 
   Accumulated deficit                         (910,743)   (342,804) 
   Accumulated other comprehensive income           573         181 
                                              ---------    -------- 
      Total stockholders' equity                463,788     605,122 
                                              ---------    -------- 
      Total liabilities and stockholders' 
       equity                                $  540,626   $ 621,484 
                                              =========    ======== 
 
 
NUVATION BIO INC. and Subsidiaries 
 
 Consolidated Statements of Operations and Comprehensive Loss 
 (In thousands, except per share data) 
                         Three Months Ended    Years Ended December 
                            December 31,                31, 
                        --------------------  ----------------------- 
                          2024       2023        2024       2023 
                         -------    -------    --------    ------- 
 
Revenue                 $  5,711   $      -   $   7,873   $      - 
Cost of revenue            4,216          -       7,078          - 
                         -------    -------    --------    ------- 
      Gross profit         1,495          -         795          - 
Operating expenses: 
   Research and 
    development           29,299     15,351      99,119     71,289 
   Acquired in-process 
    research and 
    development                -          -     425,070          - 
   Selling, general 
    and 
    administrative        26,138      5,480      69,233     28,533 
                         -------    -------    --------    ------- 
Total operating 
 expenses                 55,437     20,831     593,422     99,822 
                         -------    -------    --------    ------- 
 
Loss from operations     (53,942)   (20,831)   (592,627)   (99,822) 
                         -------    -------    --------    ------- 
 
Other income 
 (expense): 
   Interest income         6,062      7,023      27,062     24,611 
   Interest expense          (89)         -        (341)         - 
   Investment advisory 
    fees                    (227)      (260)       (976)      (949) 
   Change in fair 
    value of warrant 
    liability             (1,145)       237        (936)       497 
   Realized (loss) 
    gain on marketable 
    securities               (12)        44         (12)      (139) 
   Other expense             (92)         -        (109)         - 
                         -------    -------    --------    ------- 
Total other income 
 (expense), net            4,497      7,044      24,688     24,020 
                         -------    -------    --------    ------- 
 
Loss before income 
 taxes                   (49,445)   (13,787)   (567,939)   (75,802) 
 
Provision for income 
taxes                          -          -           -          - 
                         -------    -------    --------    ------- 
 
Net loss                $(49,445)  $(13,787)  $(567,939)  $(75,802) 
                         =======    =======    ========    ======= 
Net loss attributable 
 to common 
 stockholders 
Net loss per share 
 attributable to 
 common stockholders, 
 basic and diluted      $  (0.15)  $  (0.06)  $   (2.11)  $  (0.35) 
                         =======    =======    ========    ======= 
Weighted average 
 common shares 
 outstanding, basic 
 and diluted             336,934    218,993     268,772    218,880 
                         =======    =======    ========    ======= 
 
Comprehensive loss: 
Net loss                $(49,445)  $(13,787)  $(567,939)  $(75,802) 
Other comprehensive 
 loss, net of taxes: 
   Currency 
    translation 
    adjustment             1,131          -         537          - 
   Unrealized (loss) 
    gain on 
    available-for-sale 
    securities            (1,939)     3,479        (145)     5,707 
                         -------    -------    --------    ------- 
 
Comprehensive loss      $(50,253)  $(10,308)  $(567,547)  $(70,095) 
                         =======    =======    ========    ======= 
 

View source version on businesswire.com: https://www.businesswire.com/news/home/20250306003184/en/

 
    CONTACT:    Nuvation Bio Investor Contact: 

ir@nuvationbio.com

Nuvation Bio Media Contact:

media@nuvationbio.com

(END) Dow Jones Newswires

March 06, 2025 16:30 ET (21:30 GMT)