Full Press Release Details
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
New York, March 6, 2025 Nuvation Bio Inc. (NYSE: 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:
inhibitor: Advanced ROS1+ NSCLC
Safusidenib, mIDH1 inhibitor: Diffuse IDH1-mutant glioma
NUV-1511, drug-drug conjugate (DDC): Advanced solid tumors
NUV-868, BD2-selective BET inhibitor: Advanced solid tumors
Fourth Quarter and Full Year 2024 Financial Results
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, $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.
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.
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.
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). 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 Investor Contact:
Nuvation Bio Media Contact:
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 December 31, | Years Ended December 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 | ) |