Nuvation Bio Reports Fourth Quarter and Full Year 2023 Financial Results and Provides Business Update
- Completion of Phase 1 monotherapy study of NUV-868 and determination of MTD.
- Ongoing Phase 1b studies of NUV-868 with olaparib and enzalutamide.
- FDA clearance for NUV-1511 IND application for advanced solid tumors.
- Appointment of Dr. Robert Mashal to the Board of Directors.
- Strong financial position with $611.2 million in cash, cash equivalents, and marketable securities.
- Reduction in research and development expenses for the year ended December 31, 2023.
- Decrease in general and administrative expenses for the year ended December 31, 2023.
- Reduction in net loss for the three months and year ended December 31, 2023 compared to the same periods in 2022.
- None.
Insights
The determination of the maximum tolerated dose (MTD) for NUV-868 is a critical milestone in oncology drug development. This parameter helps to establish a safe dosage range for subsequent studies and is particularly relevant for patients with advanced solid tumors. The ability to combine NUV-868 with other agents like olaparib and enzalutamide could potentially enhance therapeutic efficacy, especially in cancers like ovarian and pancreatic, which are notorious for limited treatment options. The ongoing Phase 1b studies will provide valuable data on the safety and preliminary efficacy of these combinations.
From a financial perspective, Nuvation Bio's strong balance sheet with over $600 million in cash and securities is significant. This financial stability provides the company with a buffer to fund ongoing research and development (R&D) activities without the immediate need for external financing. The reported decrease in R&D expenses, primarily due to the termination of the NUV-422 program, suggests a strategic reallocation of resources towards more promising candidates. This could potentially improve the company's operational efficiency and focus on its most viable assets.
Analyzing the market implications, the FDA clearance of the IND application for NUV-1511 signifies the industry's interest in novel platforms like the drug-drug conjugate (DDC) platform. As the first clinical candidate from this platform, NUV-1511's progression into Phase 1/2 studies could position Nuvation Bio at the forefront of innovation in oncology treatment. The market often responds positively to such advancements, potentially increasing investor confidence in the company's pipeline.
Determined maximum tolerated dose (MTD) in Phase 1 monotherapy study of NUV-868; Phase 1b studies of NUV-868 in combination with olaparib or enzalutamide remain ongoing
Received
Strong balance sheet with cash, cash equivalents and marketable securities of
“We are pleased to announce completion of a Phase 1 monotherapy study of NUV-868 and determination of a MTD that will help inform our ongoing Phase 1b combination studies. As we announced in January, we received FDA clearance of our IND application for NUV-1511 and look forward to initiating a Phase 1/2 study for the first clinical candidate from our DDC platform in the first half of this year,” said David Hung, M.D., Founder, President, and Chief Executive Officer of Nuvation Bio. “Nuvation strongly executed across our pipeline of cancer therapies in 2023 and we plan to build on this progress in 2024 as we remain committed to bringing novel and differentiated therapies to patients with the most difficult-to-treat cancers.”
Recent Business Updates
NUV-868, BD2-selective BETi: Advanced solid tumors
- Phase 1 monotherapy study is complete. Nuvation Bio has completed the Phase 1 monotherapy study in advanced solid tumors and determined the MTD in patients.
- Phase 1b combination studies remain ongoing. Nuvation Bio continues to conduct the Phase 1b studies of NUV-868 in combination with olaparib in 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 in patients with mCRPC.
NUV-1511, Drug-Drug Conjugate Platform: Advanced solid tumors
- IND cleared for first clinical candidate, NUV-1511. Nuvation Bio received IND clearance from the FDA for the treatment of patients with various advanced solid tumors and remains on track to dose the first patient in a Phase 1/2 study of NUV-1511 in the first half of 2024.
Corporate Update:
- Appointed Dr. Robert Mashal to Board of Directors. Dr. Mashal’s experience as a seasoned pharmaceutical executive and medical oncologist will provide valuable insights.
Fourth Quarter and Full Year 2023 Financial Results
As of December 31, 2023, Nuvation Bio had cash, cash equivalents and marketable securities of
For the three months ended December 31, 2023, research and development expenses were
For the three months ended December 31, 2023, general and administrative expenses were
For the three months ended December 31, 2023, Nuvation Bio reported a net loss of
About Nuvation Bio
Nuvation Bio is a biopharmaceutical company tackling some of the greatest unmet needs in oncology by developing differentiated and novel therapeutic candidates. Nuvation Bio’s proprietary portfolio includes mechanistically distinct oncology therapeutic product candidates, each targeting some of the most difficult-to-treat types of cancer. 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, statements regarding the potential therapeutic benefit of Nuvation Bio’s product candidates and the expected initiation of a Phase 1/2 study for NUV-1511 in the first half of 2024. 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 trials 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 to be filed with the SEC on February 29, 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 | |||||||
Consolidated Balance Sheets
|
|||||||
| December 31, | |||||||
2023 |
2022 |
||||||
| Assets | |||||||
| Current assets: | |||||||
| Cash and cash equivalents | $ |
42,649 |
|
$ |
101,099 |
|
|
| Prepaid expenses |
|
1,519 |
|
|
3,819 |
|
|
| Marketable securities available-for-sale, at fair value |
|
568,564 |
|
|
559,915 |
|
|
| Interest receivable on marketable securities |
|
3,702 |
|
|
2,485 |
|
|
| Total current assets |
|
616,434 |
|
|
667,318 |
|
|
| Property and equipment, net |
|
717 |
|
|
894 |
|
|
| Lease security deposit |
|
141 |
|
|
138 |
|
|
| Operating lease right-of-use assets |
|
3,605 |
|
|
3,791 |
|
|
| Other non-current assets |
|
587 |
|
|
— |
|
|
| Total assets | $ |
621,484 |
|
$ |
672,141 |
|
|
| Liabilities and stockholders' equity | |||||||
| Current liabilities: | |||||||
| Accounts payable | $ |
2,209 |
|
$ |
2,139 |
|
|
| Current operating lease liabilities |
|
1,972 |
|
|
1,206 |
|
|
| Accrued expenses |
|
9,793 |
|
|
9,816 |
|
|
| Total current liabilities |
|
13,974 |
|
|
13,161 |
|
|
| Warrant liability |
|
353 |
|
|
850 |
|
|
| Non-current operating lease liabilities |
|
2,035 |
|
|
3,054 |
|
|
| Total liabilities |
|
16,362 |
|
|
17,065 |
|
|
| Stockholders' equity | |||||||
| Class A and Class B common stock and additional paid in capital, |
|||||||
| 1,060,000,000 (Class A 1,000,000,000, Class B 60,000,000) shares authorized as of December 31, 2023 | |||||||
| and December 31, 2022, respectively; 219,046,219 (Class A 218,046,219, Class B 1,000,000) and | |||||||
| 218,632,699 (Class A 217,632,699, Class B 1,000,000) issued and outstanding as of December 31, 2023 | |||||||
| and 2022, respectively |
|
947,745 |
|
|
927,604 |
|
|
| Accumulated deficit |
|
(342,804 |
) |
|
(267,002 |
) |
|
| Accumulated other comprehensive income (loss) |
|
181 |
|
|
(5,526 |
) |
|
| Total stockholders' equity |
|
605,122 |
|
|
655,076 |
|
|
| Total liabilities and stockholders' equity | $ |
621,484 |
|
$ |
672,141 |
|
|
| NUVATION BIO INC. and Subsidiaries | |||||||||||||||
Consolidated Statements of Operations and Comprehensive Loss
|
|||||||||||||||
| Three Months Ended December 31, | Years Ended December 31, | ||||||||||||||
2023 |
2022 |
2023 |
2022 |
||||||||||||
| Operating expenses: | |||||||||||||||
| Research and development | $ |
15,351 |
|
$ |
16,871 |
|
$ |
71,289 |
|
$ |
87,815 |
|
|||
| General and administrative |
|
5,480 |
|
|
7,464 |
|
|
28,533 |
|
|
31,919 |
|
|||
| Total operating expenses |
|
20,831 |
|
|
24,335 |
|
|
99,822 |
|
|
119,734 |
|
|||
| Loss from operations |
|
(20,831 |
) |
|
(24,335 |
) |
|
(99,822 |
) |
|
(119,734 |
) |
|||
| Other income (expense): | |||||||||||||||
| Interest income |
|
7,023 |
|
|
3,523 |
|
|
24,611 |
|
|
7,448 |
|
|||
| Investment advisory fees |
|
(260 |
) |
|
(225 |
) |
|
(949 |
) |
|
(872 |
) |
|||
| Change in fair value of warrant liability |
|
237 |
|
|
321 |
|
|
497 |
|
|
10,187 |
|
|||
| Realized gain (loss) on marketable securities |
|
44 |
|
|
(129 |
) |
|
(139 |
) |
|
(1,228 |
) |
|||
| Total other income (expense), net |
|
7,044 |
|
|
3,490 |
|
|
24,020 |
|
|
15,535 |
|
|||
| Loss before income taxes |
|
(13,787 |
) |
|
(20,845 |
) |
|
(75,802 |
) |
|
(104,199 |
) |
|||
| Provision for income taxes |
|
— |
|
|
— |
|
|
— |
|
|
— |
|
|||
| Net loss | $ |
(13,787 |
) |
$ |
(20,845 |
) |
$ |
(75,802 |
) |
$ |
(104,199 |
) |
|||
| Net loss per share attributable to common stockholders, basic and diluted | $ |
(0.06 |
) |
$ |
(0.10 |
) |
$ |
(0.35 |
) |
$ |
(0.48 |
) |
|||
| Weighted average common shares outstanding, basic and diluted |
|
218,993 |
|
|
218,497 |
|
|
218,880 |
|
|
216,721 |
|
|||
| Comprehensive loss: | |||||||||||||||
| Net loss | $ |
(13,787 |
) |
$ |
(20,845 |
) |
$ |
(75,802 |
) |
$ |
(104,199 |
) |
|||
| Other comprehensive loss, net of taxes: | |||||||||||||||
| Change in unrealized gain (loss) on available-for-sale securities, net |
|
3,479 |
|
|
2,591 |
|
|
5,707 |
|
|
(4,341 |
) |
|||
| Comprehensive loss | $ |
(10,308 |
) |
$ |
(18,254 |
) |
$ |
(70,095 |
) |
$ |
(108,540 |
) |
|||
View source version on businesswire.com: https://www.businesswire.com/news/home/20240229647917/en/
Nuvation Bio Investor Contact:
ir@nuvationbio.com
Nuvation Bio Media Contact:
nuvation@argotpartners.com
Source: Nuvation Bio Inc.
FAQ
What is the status of Phase 1 monotherapy study of NUV-868?
What are the Phase 1b studies of NUV-868 focusing on?
What clearance did Nuvation Bio receive from the FDA?
Who was appointed to the Board of Directors?
What is the financial position of Nuvation Bio as of December 31, 2023?
How did research and development expenses change in 2023 compared to 2022?
What was the net loss reported for the three months ended December 31, 2023?
