Nuvation Bio Reports Fourth Quarter and Full Year 2023 Financial Results and Provides Business Update
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
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
Recent Business Updates
NUV-868, BD2-selective BETi: Advanced solid tumors
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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
For the three months ended
For the three months ended
For the three months ended
About
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
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Consolidated Balance Sheets
|
|||||||
|
|||||||
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 |
|||||||
and |
|||||||
218,632,699 (Class A 217,632,699, Class B 1,000,000) issued and outstanding as of |
|||||||
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 |
|
|
|||||||||||||||
Consolidated Statements of Operations and Comprehensive Loss
|
|||||||||||||||
Three Months Ended |
Years Ended |
||||||||||||||
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: