Nuvation Bio Reports First Quarter 2024 Financial Results and Provides Business Update
Acquisition of AnHeart Therapeutics transformed
Updated data from the pivotal Phase 2 TRUST-I clinical study of taletrectinib, a ROS1 inhibitor, to be presented at the 2024
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
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 onSaturday, June 1, 2024 , at4:30-6:30 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
- 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,
-
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 approvedU.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 inApril 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
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, the expected timing of becoming a commercial organization, the potential therapeutic benefit of Nuvation Bio’s product candidates, the potential of the
|
|||||||
Condensed Balance Sheets | |||||||
Unaudited | |||||||
(In thousands, except share and per share data) |
|
|
|||||
|
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 |
|||||||
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 |
|
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 |
|
|
|
|||||||
Condensed Statements of Operations and Comprehensive Loss | |||||||
(In thousands, except per share data) | |||||||
For The Three Months Ended |
|
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: