Nuvation Bio Reports First Quarter 2024 Financial Results and Provides Business Update
Nuvation Bio (NYSE: NUVB) reported its Q1 2024 financial results, highlighted by the acquisition of AnHeart Therapeutics, transforming it into a late-stage oncology company. Updated data from the Phase 2 TRUST-I study of taletrectinib, a ROS1 inhibitor, will be presented at the 2024 ASCO Annual Meeting. The company also initiated a Phase 1/2 study of NUV-1511, a drug-drug conjugate for advanced solid tumors.
As of March 31, 2024, Nuvation Bio had $597.0 million in cash and securities. Q1 research and development expenses were $12.8 million, down from $18.8 million in Q1 2023, while general and administrative costs were $7.3 million, slightly down from $7.7 million. The net loss was $14.8 million, or $(0.07) per share, compared to $21.7 million, or $(0.10) per share, in Q1 2023.
- Acquisition of AnHeart Therapeutics expands Nuvation Bio into a late-stage, global oncology company.
- Updated data on taletrectinib (ROS1 inhibitor) to be presented at 2024 ASCO Annual Meeting.
- Initiation of Phase 1/2 study for NUV-1511, a new drug-drug conjugate for advanced solid tumors.
- Strong cash position with $597.0 million in cash, equivalents, and marketable securities as of March 31, 2024.
- Decrease in net loss to $14.8 million for Q1 2024, compared to $21.7 million in Q1 2023.
- Research and development expenses decreased from $18.8 million to $12.8 million year-over-year, indicating a potential reduction in ongoing research activities.
- Net loss of $14.8 million, although lower than the previous year, still represents a significant financial deficit.
- General administrative expenses remained relatively high at $7.3 million, reflecting ongoing operational costs.
Insights
The acquisition of AnHeart Therapeutics significantly bolsters Nuvation Bio’s portfolio, transforming it into a more mature oncology company. This acquisition could potentially position the company to become a commercial organization by the end of 2025. This transition is crucial, as it may open up new revenue streams and make the company more attractive to investors.
A strong balance sheet with cash and equivalents of
The stock-based compensation and other benefits driving personnel-related costs slightly up could dilute shareholder value in the short term. It’s essential to monitor how effectively Nuvation Bio integrates AnHeart Therapeutics and scales its operations.
The presentation of updated data from the pivotal Phase 2 TRUST-I clinical study of taletrectinib is noteworthy. Taletrectinib, a ROS1 inhibitor, holds promise for treating advanced ROS1-positive non-small cell lung cancer (NSCLC), which is notoriously difficult to treat. Positive data from these studies could enhance the company's credibility in the oncology field and drive significant interest from both the medical community and investors.
Additionally, the first patient treated in the Phase 1/2 study of NUV-1511, a drug-drug conjugate, represents a step forward in developing treatments for advanced solid tumors. This aligns with the current trend in oncology to create more targeted, effective therapies with potentially fewer side effects.
Continued progress in these clinical trials will be important for Nuvation Bio’s transition to a commercial entity and its long-term success. However, the risks associated with clinical trials, including the potential for adverse events and the need for FDA approval, should not be underestimated.
Nuvation Bio’s strategic move to appoint a Chief Commercial Officer and integrate new hires from AnHeart Therapeutics highlights its preparation for commercialization. This is essential for the successful launch and marketing of new therapies. Ms. Sjogren’s role will be pivotal in navigating the competitive landscape of oncology therapeutics, ensuring market access and adoption.
The company’s efforts to diversify its pipeline with multiple candidates at various stages of development further mitigate risks associated with drug development. By advancing drugs targeting different mechanisms (e.g., ROS1 inhibitors, mIDH1 inhibitors, BET inhibitors), Nuvation Bio is positioning itself as a versatile player in the oncology market.
Investors should watch for market responses to the clinical trial data presentations and any subsequent regulatory milestones. These will be key indicators of the company’s potential to capture market share and drive growth.
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
“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
For the three months ended March 31, 2024, research and development expenses were
For the three months ended March 31, 2024, general and administrative expenses were
For the three months ended March 31, 2024, Nuvation Bio reported a net loss of
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
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 INC. and Subsidiaries | |||||||
| Condensed Balance Sheets | |||||||
| Unaudited | |||||||
| (In thousands, except share and per share data) | March 31, | December 31, | |||||
|
2024 |
|
|
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, |
|||||||
| (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 |
) |
|
View source version on businesswire.com: https://www.businesswire.com/news/home/20240514169439/en/
Nuvation Bio Investor Contact:
ir@nuvationbio.com
Nuvation Bio Media Contact:
nuvation@argotpartners.com
Source: Nuvation Bio Inc.
FAQ
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