Phase 1 monotherapy study of NUV-868 and Phase
1b study of NUV-868 in combination with olaparib or enzalutamide
are ongoing
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 $619.3 million as of
September 30, 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 third quarter ended September 30, 2023,
and provided a business update.
“We remain focused on strong clinical execution of our NUV-868
program for advanced solid tumors,” said David Hung, M.D., Founder,
President, and Chief Executive Officer of Nuvation Bio. “We look
forward to expanding our clinical pipeline with an IND submission
for our first DDC clinical candidate expected before the end of the
year, building upon our unwavering commitment to bringing
transformative cancer therapies to patients who need them
most.”
Recent Business Updates
NUV-868, BD2-Selective BETi: Advanced solid tumors
- Dosing underway in the Phase 1 monotherapy study and both
regimens of the Phase 1b combination study. Nuvation Bio
continues to treat patients in the Phase 1 monotherapy study of
NUV-868 in advanced solid tumors, 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
the Phase 1b study of NUV-868 in combination with enzalutamide in
patients with mCRPC.
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.
Third Quarter 2023 Financial Results
As of September 30, 2023, Nuvation Bio had cash, cash
equivalents and marketable securities of $619.3 million. For the
three months ended September 30, 2023, research and development
expenses were $18.6 million, compared to $21.3 million for the
three months ended September 30, 2022. The decrease was primarily
due to a $0.7 million decrease in personnel-related costs driven by
a headcount reduction as well as a $2.0 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 September 30, 2023, general and
administrative expenses were $7.8 million, compared to $8.1 million
for the three months ended September 30, 2022. The decrease was
primarily due to a $0.6 million decrease in insurance and a $0.1
million decrease in recruiting and computer expenses offset by a
$0.4 million increase in personnel-related costs driven by
stock-based compensation and other benefits.
For the three months ended September 30, 2023, Nuvation Bio
reported a net loss of $19.6 million, or $(0.09) per share. This
compares to a net loss of $27.2 million, or $(0.12) 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 November 2, 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 Unaudited (In thousands, except share and per
share data)
September 30, December 31,
2023
2022
Assets Current assets: Cash and cash equivalents
$
24,395
$
101,099
Prepaid expenses and other current assets
2,976
3,819
Marketable securities
594,944
559,915
Interest receivable on marketable securities
3,033
2,485
Total current assets
625,348
667,318
Property and equipment, net
764
894
Operating lease right-of-use assets
4,033
3,791
Lease security deposit
138
138
Other non-current assets
587
—
Total assets
$
630,870
$
672,141
Liabilities and stockholders' equity Current
liabilities: Accounts payable
$
2,373
$
2,139
Current operating lease liabilities
1,915
1,206
Accrued expenses
11,855
9,816
Total current liabilities
16,143
13,161
Warrant liability
590
850
Non-current operating lease liabilities
2,549
3,054
Total liabilities
19,282
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 September 30, 2023 and December 31, 2022,
218,944,053 (Class A 217,944,053, 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 September 30, 2023 and December 31, 2022,
respectively
943,903
927,604
Accumulated deficit
(329,017
)
(267,002
)
Accumulated other comprehensive income
(3,298
)
(5,526
)
Total stockholders' equity
611,588
655,076
Total liabilities and stockholders' equity
$
630,870
$
672,141
NUVATION BIO INC. and Subsidiaries
Consolidated Statements of Operations and Comprehensive Loss
(In thousands, except per share data)
Three Months Ended
September 30, Nine Months Ended September 30,
2023
2022
2023
2022
Operating expenses: Research and development
$
18,561
$
21,294
$
55,938
$
70,944
General and administrative
7,778
8,044
23,053
24,455
Total operating expenses
26,339
29,338
78,991
95,399
Loss from operations
(26,339
)
(29,338
)
(78,991
)
(95,399
)
Other income (expense): Interest income
6,523
2,127
17,588
3,925
Investment advisory fees
(228
)
(263
)
(689
)
(647
)
Change in fair value of warrant liability
383
462
260
9,866
Realized gain (loss) on marketable securities
12
(191
)
(183
)
(1,099
)
Total other income (expense), net
6,690
2,135
16,976
12,045
Loss before income taxes
(19,649
)
(27,203
)
(62,015
)
(83,354
)
Provision for income taxes
—
—
—
—
Net loss
$
(19,649
)
$
(27,203
)
$
(62,015
)
$
(83,354
)
Net loss attributable to common stockholders Net loss per
share attributable to common stockholders, basic and diluted
$
(0.09
)
$
(0.12
)
$
(0.28
)
$
(0.39
)
Weighted average common shares outstanding, basic and diluted
218,935
218,300
218,842
216,123
Comprehensive loss: Net loss
$
(19,649
)
$
(27,203
)
$
(62,015
)
$
(83,354
)
Other comprehensive loss, net of taxes: Unrealized gain (loss) on
available-for-sale securities
1,097
(1,139
)
2,228
(6,932
)
Comprehensive loss
$
(18,552
)
$
(28,342
)
$
(59,787
)
$
(90,286
)
View source
version on businesswire.com: https://www.businesswire.com/news/home/20231102715352/en/
Nuvation Bio Investor Contact: ir@nuvationbio.com
Nuvation Bio Media Contact:
nuvation@argotpartners.com
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