Nuvation Bio Reports Second Quarter 2024 Financial Results and Provides Business Update
Efficacy and safety data from the pivotal Phase 2 TRUST-I clinical study of taletrectinib, a ROS1 inhibitor, published in the
Company to present pooled data from the pivotal Phase 2 TRUST-I and TRUST-II studies at the
Company to present data from the global, pivotal Phase 2 TRUST-II study at the 2024
Taletrectinib Granted Orphan Drug Designation by the
Strong balance sheet with cash, cash equivalents, and marketable securities of
“In the second quarter, we were pleased to share data at ASCO from TRUST-I, the pivotal study of taletrectinib in
Recent Pipeline Updates:
Taletrectinib, ROS1 inhibitor: Advanced ROS1-positive NSCLC
-
Latest data from the Phase 2 TRUST-I clinical study evaluating taletrectinib in patients in
China with advanced ROS1-positive NSCLC was published in theJournal of Clinical Oncology and presented at the 2024 ASCO Annual Meeting. -
Latest pooled data from the pivotal Phase 2 TRUST-I and TRUST-II studies to be presented at the
ESMO Congress 2024 in September, which will support the Company’s planned NDA in theU.S. - Latest data from the global, pivotal Phase 2 TRUST-II study to be presented at the WCLC in September.
-
Granted Orphan Drug Designation by the
U.S. FDA for the treatment of ROS1-positive NSCLC and other NSCLC indications.
Safusidenib, mIDH1 inhibitor: Diffuse IDH1-mutant glioma
- Global phase 2 study of safusidenib for treatment of patients with diffuse IDH1-mutant glioma remains ongoing.
NUV-1511, drug-drug conjugate (DDC): Advanced solid tumors
- Phase 1/2 dose escalation study of NUV-1511 for the treatment of patients with various advanced solid tumors remains ongoing.
NUV-868, BD2-selective
- Concluded the Phase 1b dose escalation study of NUV-868 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.
-
Completed an internal analysis of efficacy and safety data collected from the Phase 1 monotherapy and Phase 1b combination studies of NUV-868. Following this analysis,
Nuvation Bio decided not to initiate a Phase 2 study of NUV-868 as a monotherapy or in combination with olaparib or enzalutamide in the advanced solid tumor indications that were part of the Phase 1 and Phase 1b study designs. The Company is evaluating next steps for the NUV-868 program, including further development in combination with approved products for indications in which BD2-selectiveBET inhibitors may improve outcomes for patients.
Second Quarter 2024 Financial Results
As of
For the three months ended
On
For the three months ended
For the three months ended
About Taletrectinib
Taletrectinib is an oral, potent, central nervous system-active, selective, next-generation ROS1 inhibitor specifically designed for the treatment of patients with 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 (NCT04395677) in
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, our expectations regarding a
|
|||||||
Consolidated Balance Sheets | |||||||
Unaudited | |||||||
(In thousands, except share and per share data) |
|
|
|||||
2024 |
2023 |
||||||
Assets | |||||||
Current assets: | |||||||
Cash and cash equivalents |
$ |
34,285 |
|
$ |
42,649 |
|
|
Accounts receivable, net of allowance for credit loss of $nil |
|
117 |
|
|
- |
|
|
Prepaid expenses and other current assets |
|
5,991 |
|
|
1,519 |
|
|
Marketable securities |
|
542,884 |
|
|
568,564 |
|
|
Interest receivable on marketable securities |
|
3,895 |
|
|
3,702 |
|
|
Total current assets |
|
587,172 |
|
|
616,434 |
|
|
Property and equipment, net of accumulated depreciation of |
|
751 |
|
|
717 |
|
|
Intangible assets, net of amortization of |
|
2,932 |
|
|
- |
|
|
Operating lease right-of-use assets |
|
2,723 |
|
|
3,605 |
|
|
Lease security deposit |
|
143 |
|
|
141 |
|
|
Other non-current assets |
|
1,075 |
|
|
587 |
|
|
Total assets |
$ |
594,796 |
|
$ |
621,484 |
|
|
Liabilities, mezzanine equity and stockholders' equity | |||||||
Current liabilities: | |||||||
Accounts payable |
$ |
5,211 |
|
$ |
2,209 |
|
|
Current operating lease liabilities |
|
2,076 |
|
|
1,972 |
|
|
Contract liabilities, current portion |
|
12,200 |
|
|
- |
|
|
Short-term borrowings |
|
11,634 |
|
|
- |
|
|
Accrued expenses |
|
19,974 |
|
|
9,793 |
|
|
Total current liabilities |
|
51,095 |
|
|
13,974 |
|
|
Warrant liability |
|
1,441 |
|
|
353 |
|
|
Contract liabilities, net of current portion |
|
9,157 |
|
|
- |
|
|
Non-current operating lease liabilities |
|
972 |
|
|
2,035 |
|
|
Total liabilities |
|
62,665 |
|
|
16,362 |
|
|
Mezzanine equity; | |||||||
Class A convertible preferred stock, |
|
274,938 |
|
|
- |
|
|
Total mezzanine equity |
|
274,938 |
|
|
- |
|
|
Stockholders' equity | |||||||
Class A and Class B common stock and additional paid in capital, |
|
1,078,547 |
|
|
947,745 |
|
|
Accumulated deficit |
|
(820,088 |
) |
|
(342,804 |
) |
|
Accumulated other comprehensive income |
|
(1,266 |
) |
|
181 |
|
|
Total stockholders' equity |
|
257,193 |
|
|
605,122 |
|
|
Total liabilities, mezzanine equity and stockholders' equity |
$ |
594,796 |
|
$ |
621,484 |
|
|
|
|||||||||||||||
Consolidated Statements of Operations and Comprehensive Loss | |||||||||||||||
(In thousands, except per share data) | |||||||||||||||
Three Months Ended |
Six Months Ended |
||||||||||||||
2024 |
2023 |
2024 |
2023 |
||||||||||||
Revenue |
$ |
1,435 |
|
$ |
- |
|
$ |
1,435 |
|
$ |
- |
|
|||
Cost of revenue |
|
1,347 |
|
|
- |
|
|
1,347 |
|
|
- |
|
|||
Gross profit |
|
88 |
|
|
- |
|
|
88 |
|
|
- |
|
|||
Operating expenses: | |||||||||||||||
Research and development |
|
29,247 |
|
|
18,590 |
|
|
42,089 |
|
|
37,377 |
|
|||
Acquired in-process research and development |
|
425,070 |
|
|
- |
|
|
425,070 |
|
|
- |
|
|||
General and administrative |
|
16,156 |
|
|
7,541 |
|
|
23,513 |
|
|
15,275 |
|
|||
Total operating expenses |
|
470,473 |
|
|
26,131 |
|
|
490,672 |
|
|
52,652 |
|
|||
Loss from operations |
|
(470,385 |
) |
|
(26,131 |
) |
|
(490,584 |
) |
|
(52,652 |
) |
|||
Other income (expense): | |||||||||||||||
Interest income |
|
7,144 |
|
|
6,086 |
|
|
14,274 |
|
|
11,065 |
|
|||
Interest expense |
|
(132 |
) |
|
- |
|
|
(132 |
) |
|
- |
|
|||
Investment advisory fees |
|
(247 |
) |
|
(231 |
) |
|
(512 |
) |
|
(461 |
) |
|||
Change in fair value of warrant liability |
|
1,135 |
|
|
(265 |
) |
|
(324 |
) |
|
(123 |
) |
|||
Realized loss on marketable securities |
|
(7 |
) |
|
(99 |
) |
|
(6 |
) |
|
(195 |
) |
|||
Total other income (expense), net |
|
7,893 |
|
|
5,491 |
|
|
13,300 |
|
|
10,286 |
|
|||
Loss before income taxes |
|
(462,492 |
) |
|
(20,640 |
) |
|
(477,284 |
) |
|
(42,366 |
) |
|||
Provision for income taxes |
|
- |
|
|
- |
|
|
- |
|
|
- |
|
|||
Net loss |
$ |
(462,492 |
) |
$ |
(20,640 |
) |
$ |
(477,284 |
) |
$ |
(42,366 |
) |
|||
Net loss attributable to common stockholders | |||||||||||||||
Net loss per share attributable to common stockholders, basic and diluted |
$ |
(1.89 |
) |
$ |
(0.09 |
) |
$ |
(2.06 |
) |
$ |
(0.19 |
) |
|||
Weighted average common shares outstanding, basic and diluted |
|
244,738 |
|
|
218,848 |
|
|
231,893 |
|
|
218,795 |
|
|||
Comprehensive loss: | |||||||||||||||
Net loss |
$ |
(462,492 |
) |
$ |
(20,640 |
) |
$ |
(477,284 |
) |
$ |
(42,366 |
) |
|||
Other comprehensive loss, net of taxes: | |||||||||||||||
Currency translation adjustment |
|
148 |
|
|
- |
|
|
148 |
|
|
- |
|
|||
Unrealized (loss) gain on available-for-sale securities |
|
(245 |
) |
|
(1,457 |
) |
|
(1,595 |
) |
|
1,131 |
|
|||
Comprehensive loss |
$ |
(462,589 |
) |
$ |
(22,097 |
) |
$ |
(478,731 |
) |
$ |
(41,235 |
) |
View source version on businesswire.com: https://www.businesswire.com/news/home/20240805155584/en/
Nuvation Bio Investor Contact:
ir@nuvationbio.com
Nuvation Bio Media Contact:
nuvation@argotpartners.com
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