Enrollment ongoing in the Phase 1b study of
NUV-868 in combination with olaparib or enzalutamide
Enrollment ongoing in the Phase 1 monotherapy
study of NUV-868
Expect to submit an IND for first Drug-Drug
Conjugate (DDC) clinical candidate by year end 2023
Strong balance sheet with cash, cash
equivalents and marketable securities of $646.6 million as of March
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 its
financial results for the first quarter ended March 31, 2023, and
provided a business update.
“We saw strong clinical execution in the first quarter as we
continued to enroll patients in the Phase 1 monotherapy and Phase
1b combination studies of NUV-868,” said David Hung, M.D., Founder,
President, and Chief Executive Officer of Nuvation Bio. “We look
forward to submitting an IND for our first DDC clinical candidate
by the end of this year, demonstrating our ongoing effort to tackle
some of the greatest unmet needs in oncology.”
Recent Business Updates
NUV-868, BD2-Selective BETi: Advanced solid tumors
- Dosing underway in both regimens of the Phase 1b combination
study. The Company continues to enroll the Phase 1b study 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.
- Dosing underway in the Phase 1 monotherapy study. The
Company continues to enroll the Phase 1 monotherapy study in
advanced solid tumors.
Drug-Drug Conjugate Platform: Solid tumors
- Nominated first clinical candidate. Nuvation Bio remains
on track to submit an Investigational New Drug (IND) application
for an undisclosed DDC candidate with the U.S. Food and Drug
Administration by year end 2023.
First Quarter 2023 Financial Results
As of March 31, 2023, Nuvation Bio had cash, cash equivalents
and marketable securities of $646.6 million. For the three months
ended March 31, 2023, research and development expenses were $18.8
million, compared to $20.7 million for the three months ended March
31, 2022. The decrease was primarily due to a $1.3 million decrease
in personnel-related costs driven by a headcount reduction as well
as a $0.6 million decrease in third-party costs related to research
services and manufacturing primarily due to the termination of the
NUV-422 program.
For the three months ended March 31, 2023, general and
administrative expenses were $7.7 million, compared to $7.5 million
for the three months ended March 31, 2022. The increase was
primarily due to a $1.1 million increase in personnel-related costs
driven by stock-based compensation and other benefits offset by a
$0.3 million decrease in insurance, a $0.3 million decrease in
legal fees and a $0.3 million decrease in other professional
fees.
For the three months ended March 31, 2023, Nuvation Bio reported
a net loss of $21.7 million, or $(0.10) per share. This compares to
a net loss of $21.3 million, or $(0.10) per share, for the
comparable period in 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, the expected continued momentum of
Nuvation Bio’s clinical trials and the expected timing of an IND
filing for Nuvation Bio’s first DDC clinical candidate. 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-Q to be filed with the SEC on May 4, 2023, 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 Condensed Balance
Sheets Unaudited (In thousands, except share and per share
data)
March 31,
December 31,
2023
2022
Assets Current assets: Cash and cash equivalents
$
30,071
$
101,099
Prepaid expenses and other current assets
3,682
3,819
Marketable securities
616,538
559,915
Interest receivable on marketable securities
2,273
2,485
Total current assets
652,564
667,318
Property and equipment, net
838
894
Lease security deposit
138
138
Operating lease right-of-use assets
3,519
3,791
Total assets
$
657,059
$
672,141
Liabilities and stockholders' equity Current
liabilities: Accounts payable
$
2,945
$
2,139
Current operating lease liabilities
1,244
1,206
Accrued expenses
8,362
9,816
Total current liabilities
12,551
13,161
Warrant liability
708
850
Non-current operating lease liabilities
2,727
3,054
Total liabilities
15,986
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 March 31, 2023 and December 31, 2022, 218,803,722
(Class A 217,803,722, Class B 1,000,000) and 218,632,699 (Class A
217,632,699, Class B 1,000,000) shares issued and outstanding as of
March 31, 2023 and December 31, 2022, respectively
932,739
927,604
Accumulated deficit
(288,728
)
(267,002
)
Accumulated other comprehensive income
(2,938
)
(5,526
)
Total stockholders' equity
641,073
655,076
Total liabilities and stockholders' equity
$
657,059
$
672,141
NUVATION BIO INC. and Subsidiaries
Condensed Statements of Operations and Comprehensive
Loss
(In thousands, except per share data)
For The Three Months Ended March
31,
2023
2022
Operating expenses: Research and development
$
18,787
$
20,729
General and administrative
7,734
7,463
Total operating expenses
26,521
28,192
Loss from operations
(26,521
)
(28,192
)
Other income (expense): Interest income
4,979
958
Investment advisory fees
(230
)
(169
)
Change in fair value of warrant liability
142
6,324
Net loss on marketable securities
(96
)
(214
)
Total other income (expense), net
4,795
6,899
Loss before income taxes
(21,726
)
(21,293
)
Provision for income taxes
—
—
Net loss
$
(21,726
)
$
(21,293
)
Net loss per share attributable to common stockholders,
basic and diluted
$
(0.10
)
$
(0.10
)
Weighted average common shares outstanding, basic and diluted
218,741
213,411
Comprehensive loss: Net loss
$
(21,726
)
$
(21,293
)
Other comprehensive loss, net of taxes: Unrealized gain (loss) on
available-for-sale securities, net
2,588
(5,032
)
Comprehensive loss
$
(19,138
)
$
(26,325
)
View source
version on businesswire.com: https://www.businesswire.com/news/home/20230504005070/en/
Nuvation Bio Investor Contact: ir@nuvationbio.com
Nuvation Bio Media Contact:
nuvation@argotpartners.com
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