Initiated both dosing regimens of the Phase 1b
study of NUV-868 in combination with olaparib or enzalutamide
Dosing ongoing for Phase 1 monotherapy study of
NUV-868
Nominated undisclosed Drug-Drug Conjugate (DDC)
as first clinical candidate; expect to submit an IND by year end
2023
Strong balance sheet with cash, cash
equivalents and marketable securities of $661.0 million as of
December 31, 2022
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, 2022, and provided a business update.
“In the fourth quarter, we dosed the first patient in both
dosing regimens of our Phase 1b study of NUV-868 in combination
with olaparib or enzalutamide. This milestone sustains the
program’s strong momentum, which we expect to continue in 2023. As
we advance the Phase 1 monotherapy and combination studies of
NUV-868, we look forward to more deeply understanding how this
therapy may be able to improve the lives of patients with advanced
solid tumors,” said David Hung, M.D., Founder, President, and Chief
Executive Officer of Nuvation Bio. “We also expect to submit an IND
for the first clinical candidate from our DDC platform by the end
of the year.”
Recent Business Updates
NUV-868, BD2-Selective BETi: Advanced solid tumors
- Dosed the first patient in both dosing regimens of the Phase
1b combination study. In December 2022, Nuvation Bio initiated
a 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 expects
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.
Fourth Quarter and Full Year 2022 Financial Results
As of December 31, 2022, Nuvation Bio had cash, cash equivalents
and marketable securities of $661.0 million.
For the three months ended December 31, 2022, research and
development expenses were $16.9 million, compared to $22.0 million
for the three months ended December 31, 2021. The decrease was
primarily due to a $3.7 million decrease in third-party costs
related to research services and manufacturing, as well as a $1.5
million decrease in personnel-related costs driven by the
termination of the NUV-422 program offset by a $0.1 million
increase in miscellaneous expenses. Research and development
expenses for the year ended December 31, 2022 were $87.8 million
compared to $69.0 million for the year ended December 31, 2021.
For the three months ended December 31, 2022, general and
administrative expenses were $7.4 million, compared to $7.6 million
for the three months ended December 31, 2021. The decrease was
primarily due to a $0.4 million decrease in legal fees, a $0.2
million decrease in professional fees, and a $0.2 million decrease
in miscellaneous expenses offset by a $0.5 million increase in
personnel-related costs driven by an increase in headcount and
stock-based compensation and a $0.1 million increase in taxes.
General and administrative expenses for the year ended December 31,
2022 were $31.9 million compared to $24.3 million for the year
ended December 31, 2021.
For the three months ended December 31, 2022, Nuvation Bio
reported a net loss of $20.8 million, or $(0.10) per share. This
compares to a net loss of $25.1 million, or $(0.12) per share, for
the comparable period in 2021. Net loss for the year ended December
31, 2022 was $104.2 million compared to $86.8 million for the year
ended December 31, 2021.
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 nominated 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
Annual Report on Form 10-K filed on March 15, 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 Consolidated
Balance Sheets (In thousands, except share and per share data)
December 31,
2022
2021
Assets Current assets: Cash and cash equivalents
$
101,099
$
132,423
Prepaid expenses
3,819
3,642
Marketable securities available-for-sale, at fair value
559,915
632,969
Interest receivable on marketable securities
2,485
3,039
Total current assets
667,318
772,073
Property and equipment, net
894
786
Lease security deposit
138
421
Operating lease right-of-use assets
3,791
2,871
Total assets
$
672,141
$
776,151
Liabilities and stockholders' equity Current
liabilities: Accounts payable
$
2,139
$
3,925
Current operating lease liabilities
1,206
863
Accrued expenses
9,816
12,137
Total current liabilities
13,161
16,925
Warrant liability
850
11,037
Non-current operating lease liabilities
3,054
2,192
Total liabilities
17,065
30,154
Stockholders' equity Class A and Class B common stock and
additional paid in capital, $0.0001 par value per share;
1,060,000,000 shares authorized as of December 31, 2022 (Class A
1,000,000,000, Class B 60,000,000) and December 31, 2021,
respectively; 218,632,699 (Class A 217,632,699, Class B 1,000,000)
and 149,042,155 (Class A 91,397,142, 217,948,568 (Class A
216,948,568, Class B 1,000,000) issued and outstanding as of
December 31, 2022 and 2021, respectively
927,604
909,985
Accumulated deficit
(267,002)
(162,803)
Accumulated other comprehensive income
(5,526)
(1,185)
Total stockholders' equity
655,076
745,997
Total liabilities and stockholders' equity
$
672,141
$
776,151
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,
2022
2021
2022
2021
Operating expenses: Research and development
$
16,871
$
22,002
$
87,815
$
69,037
General and administrative
7,464
7,607
31,919
24,281
Total operating expenses
24,335
29,609
119,734
93,318
Loss from operations
(24,335)
(29,609)
(119,734)
(93,318)
Other income (expense): Interest income
3,523
902
7,448
2,963
Investment advisory fees
(225)
(190)
(872)
(644)
Change in fair value of warrant liability
321
3,899
10,187
4,231
Net loss on marketable securities
(129)
(136)
(1,228)
(80)
Total other income (expense), net
3,490
4,475
15,535
6,470
Loss before income taxes
(20,845)
(25,134)
(104,199)
(86,848)
Provision for income taxes
—
—
—
—
Net loss
$
(20,845)
$
(25,134)
$
(104,199)
$
(86,848)
Net loss per share attributable to common stockholders,
basic and diluted
$
(0.10)
$
(0.12)
$
(0.48)
$
(0.44)
Weighted average common shares outstanding, basic and diluted
218,497
210,224
216,721
197,887
Comprehensive loss: Net loss
$
(20,845)
$
(25,134)
$
(104,199)
$
(86,848)
Other comprehensive income (loss), net of taxes: Unrealized gain
(loss) on available-for-sale securities, net
2,591
(1,573)
(4,341)
(2,742)
Comprehensive loss
$
(18,254)
$
(26,707)
$
(108,540)
$
(89,590)
View source
version on businesswire.com: https://www.businesswire.com/news/home/20230315005621/en/
Nuvation Bio Investor Contact: ir@nuvationbio.com
Nuvation Bio Media Contact:
nuvation@argotpartners.com
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