Full Press Release Details
Nuvation Bio Reports First Quarter 2025 Financial Results and Provides Business Update
New Drug Application (NDA) for taletrectinib for advanced ROS1-positive (ROS1+) non-small cell lung
cancer (NSCLC) under U.S. Food and Drug Administration (FDA) Priority Review; Prescription Drug User Fee Act (PDUFA) goal date of June 23, 2025
Published pooled results from pivotal Phase 2 TRUST-I and
TRUST-II studies of taletrectinib in Journal of Clinical Oncology demonstrating high response rates, durable responses, and a favorable safety profile
Strong balance sheet with cash, cash equivalents, and marketable securities of $461.7 million as of March 31, 2025
Company to host a conference call today at 4:30 p.m. ET
New York, May 7, 2025 Nuvation Bio Inc. (NYSE: NUVB), a global oncology company tackling some of the toughest challenges in
cancer treatment, today reported financial results for the first quarter ended March 31, 2025, and provided a business update.
continued to execute with focus in the first quarter as we prepare for the potential U.S. approval and launch of taletrectinib for advanced ROS1-positive non-small cell lung cancer, said David Hung,
M.D., Founder, President, and Chief Executive Officer of Nuvation Bio. Data recently published in the Journal of Clinical Oncology and presented at the European Lung Cancer Congress and the American Association for Cancer Research
Annual Meeting further reinforce taletrectinib s potential to deliver a differentiated profile with strong efficacy, high central nervous system activity, and favorable tolerability. We also continue to advance our broader pipeline, including
safusidenib and NUV-1511, for which we plan to provide program updates later this year. With a team that has successfully brought numerous oncology therapies to market and a strong balance sheet, we are
well-positioned to enter our next chapter as a commercial-stage company.
Recent Pipeline Updates:
Taletrectinib, ROS1 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
First Quarter 2025 Financial Results
March 31, 2025, Nuvation Bio had cash, cash equivalents, and marketable securities of $461.7 million.
For the three months ended March 31,
2025, research and development expenses were $24.6 million, compared to $12.8 million for the three months ended March 31, 2024. The increase was primarily due to a $6.2 million increase in personnel-related costs driven by the
acquisition of AnHeart as well as stock-based compensation and other benefits and $0.2 million increase in amortization of assembled workforce and $5.4 million increase in third-party costs related to clinical trial expense for
For the three months ended March 31, 2025, selling, general, and administrative expenses were
$35.4 million, compared to $7.4 million for the three months ended March 31, 2024. The increase was due to a $10.7 million increase in personnel-related costs as a result of the acquisition of AnHeart, $12.2 million increase
in sales and marketing expenses, $1.4 million increase in professional fees, $0.5 million increase in occupancy expenses, $1.1 million increase in legal fees, $0.2 million increase in foreign currency impact and $2.0 million
increase in other expenses as a result of the integration of AnHeart offset by $0.1 million decrease in taxes.
For the three months ended
March 31, 2025, Nuvation Bio reported a net loss of $53.2 million, or $(0.16) per share. This compares to a net loss of $14.8 million, or $(0.07) per share, for the comparable period in 2024.
Conference Call and Webcast
Nuvation Bio will host a
conference call on Wednesday, May 7, 2025, at 4:30 p.m. ET, during which company executives will provide an overview of its programs, summarize the commercial strategy for taletrectinib, and review financial results for the first quarter of
Investors and the general public are invited to listen to the live webcast and can register on the Nuvation Bio website at
https://investors.nuvationbio.com. Those unable to register can access the live conference call by dialing +1 833-470-1428 (U.S. toll-free) and entering access
A replay of the webcast will be available on the Company s website shortly after the conference call concludes.
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 oncology
company focused on tackling some of the toughest challenges in cancer treatment by developing therapies that create a profound, positive impact on patients lives. Our diverse pipeline includes taletrectinib, a next-generation ROS1 inhibitor;
safusidenib, a brain-penetrant IDH1 inhibitor; NUV-1511, an innovative drug-drug conjugate (DDC) designed for targeted cancer treatment; and NUV-868, a BD2-selective BET inhibitor.
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, 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-Q filed with the SEC on May 7, 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
| March 31, 2025 | December 31, 2024 | |||||||
| (unaudited) | ||||||||
| Assets | ||||||||
| Current assets: | ||||||||
| Cash and cash equivalents | $ | 47,977 | $ | 35,723 | ||||
| Accounts receivable, net of allowance for credit loss of $nil | 409 | 12,722 | ||||||
| Inventory | 14 | |||||||
| Prepaid expenses and other current assets | 8,415 | 7,271 | ||||||
| Marketable securities | 413,699 | 466,969 | ||||||
| Interest receivable on marketable securities | 5,053 | 3,570 | ||||||
| Total current assets | 475,567 | 526,255 | ||||||
| Property and equipment, net of accumulated depreciation of $971 and $874, respectively | 562 | 586 | ||||||
| Intangible assets, net of accumulated amortization of $660 and $448, respectively | 4,410 | 4,622 | ||||||
| Operating lease right-of-use assets | 5,334 | 2,402 | ||||||
| Other non-current assets | 6,616 | 6,761 | ||||||
| Total assets | $ | 492,489 | $ | 540,626 | ||||
| Liabilities and stockholders equity | ||||||||
| Current liabilities: | ||||||||
| Accounts payable | $ | 10,537 | $ | 6,348 | ||||
| Current operating lease liabilities | 1,889 | 1,663 | ||||||
| Contract liabilities, current portion | 10,769 | 11,117 | ||||||
| Short-term borrowings | 5,685 | 6,283 | ||||||
| Accrued expenses | 23,892 | 32,833 | ||||||
| Total current liabilities | 52,772 | 58,244 | ||||||
| Warrant liability | 2,804 | 2,053 | ||||||
| Contract liabilities, net of current portion | 13,614 | 15,572 | ||||||
| Non-current operating lease liabilities | 3,839 | 969 | ||||||
| Total liabilities | 73,029 | 76,838 | ||||||
| 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, 2025 and December 31, 2024, respectively; 339,840,425 (Class A 338,840,425, Class B 1,000,000) and 337,837,872 (Class A 336,837,872, Class B 1,000,000) issued and outstanding as of December 31, 2024 and 2023, respectively | 1,382,894 | 1,373,958 | ||||||
| Accumulated deficit | (963,979 | ) | (910,743 | ) | ||||
| Accumulated other comprehensive income | 545 | 573 | ||||||
| Total stockholders equity | 419,460 | 463,788 | ||||||
| Total liabilities and stockholders equity | $ | 492,489 | $ | 540,626 |
NUVATION BIO INC. and Subsidiaries
Consolidated Statements of Operations and Comprehensive Loss
(Unaudited, in thousands, except per share data)
| Three Months Ended March 31, | ||||||||
| 2025 | 2024 | |||||||
| Revenue | $ | 3,084 | $ | |||||
| Cost of revenue | 2,094 | |||||||
| Gross profit | 990 | |||||||
| Operating expenses: | ||||||||
| Research and development | 24,601 | 12,842 | ||||||
| Selling, general and administrative | 35,393 | 7,357 | ||||||
| Total operating expenses | 59,994 | 20,199 | ||||||
| Loss from operations | (59,004 | ) | (20,199 | ) | ||||
| Other income (expense): | ||||||||
| Interest income | 5,321 | 7,130 | ||||||
| Interest expense | (54 | ) | ||||||
| Investment advisory fees | (203 | ) | (265 | ) | ||||
| Change in fair value of warrant liability | (751 | ) | (1,459 | ) | ||||
| Realized gain on marketable securities | 3 | 1 | ||||||
| Other income | 1,452 | |||||||
| Total other income (expense), net | 5,768 | 5,407 | ||||||
| Loss before income taxes | (53,236 | ) | (14,792 | ) | ||||
| Provision for income taxes | ||||||||
| Net loss | $ | (53,236 | ) | $ | (14,792 | ) | ||
| Net loss attributable to common stockholders | ||||||||
| Net loss per share attributable to common stockholders, basic and diluted | $ | (0.16 | ) | $ | (0.07 | ) | ||
| Weighted average common shares outstanding, basic and diluted | 338,612 | 219,048 | ||||||
| Comprehensive loss: | ||||||||
| Net loss | $ | (53,236 | ) | $ | (14,792 | ) | ||
| Other comprehensive loss, net of taxes: | ||||||||
| Currency translation adjustment | 465 | |||||||
| Unrealized (loss) gain on available-for-sale securities | (493 | ) | (1,350 | ) | ||||
| Comprehensive loss | $ | (53,264 | ) | $ | (16,142 | ) |