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 U.S. Food and Drug Administration
(FDA) clearance of Investigational New Drug (IND) application for
NUV-1511, the first clinical candidate from our novel drug-drug
conjugate (DDC) platform
Strong balance sheet with cash, cash
equivalents and marketable securities of $611.2 million as of
December 31, 2023
Nuvation Bio Inc. (NYSE: NUVB), a biopharmaceutical company
tackling some of the greatest unmet needs in oncology by developing
differentiated and novel therapeutic candidates, today reported
financial results for the fourth quarter and full year ended
December 31, 2023, and provided a business update.
“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 $611.2 million.
For the three months ended December 31, 2023, research and
development expenses were $15.4 million, compared to $16.9 million
for the three months ended December 31, 2022. The decrease was
primarily due to a $1.7 million decrease in third-party costs
related to research services and manufacturing driven by the
termination of the NUV-422 program offset by a $0.2 million
increase in personnel-related costs. Research and development
expenses for the year ended December 31, 2023 were $71.3 million
compared to $87.8 million for the year ended December 31, 2022.
For the three months ended December 31, 2023, general and
administrative expenses were $5.5 million, compared to $7.4 million
for the three months ended December 31, 2022. The decrease was
primarily due to a $1.3 million decrease in personnel-related
costs, $0.6 million decrease in insurance, a $0.2 million decrease
in professional fees, a $0.1 million decrease in taxes and a $0.1
million decrease in miscellaneous expenses offset by $0.2 million
increase in legal fees, and a $0.2 million increase in occupancy.
General and administrative expenses for the year ended December 31,
2023 were $28.5 million compared to $31.9 million for the year
ended December 31, 2022.
For the three months ended December 31, 2023, Nuvation Bio
reported a net loss of $13.8 million, or $(0.06) per share. This
compares to a net loss of $20.8 million, or $(0.10) per share, for
the comparable period in 2022. Net loss for the year ended December
31, 2023 was $75.8 million compared to $104.2 million for the year
ended December 31, 2022.
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 New
York and San Francisco. For more information, please visit
www.nuvationbio.com.
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 (In thousands, except share
and per share data)
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, $0.0001 par value per
share; 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 (In thousands, except per share data)
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
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