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
Announced formation of oncology-focused
Scientific Advisory Board
Strong balance sheet with cash, cash
equivalents and marketable securities of $630.9 million as of June
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 second quarter ended June 30, 2023, and
provided a business update.
"We continue to enroll patients in the Phase 1 and Phase 1b
studies of NUV-868 where dose escalation is ongoing. We also look
forward to expanding our pipeline as we progress our first
nominated DDC clinical candidate toward an IND filing, which we
expect by the end of 2023,” said David Hung, M.D., Founder,
President, and Chief Executive Officer of Nuvation Bio. "Lastly, we
announced the formation of our Scientific Advisory Board, composed
of leading experts in oncology drug and clinical development. We
are excited to work alongside them to bring innovative new
therapies to cancer patients.”
Recent Business Updates
NUV-868, BD2-Selective BETi: Advanced solid tumors
- Dosing underway in both regimens of the Phase 1b combination
study. Nuvation Bio 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.
Nuvation Bio 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.
Corporate Updates
- Announced formation of oncology-focused Scientific Advisory
Board. The Scientific Advisory Board will work alongside the
Nuvation Bio management team to advance its pipeline of therapeutic
candidates for some of the most difficult-to-treat cancers.
Second Quarter 2023 Financial Results
As of June 30, 2023, Nuvation Bio had cash, cash equivalents and
marketable securities of $630.9 million. For the three months ended
June 30, 2023, research and development expenses were $18.6
million, compared to $28.9 million for the three months ended June
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 $9.6 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 June 30, 2023, general and
administrative expenses were $7.5 million, compared to $8.9 million
for the three months ended June 30, 2022. The decrease was
primarily due to a $0.6 million decrease in insurance, a $0.6
million decrease in recruiting and computer expenses, a $0.6
million decrease in legal fees and a $0.2 million decrease in other
professional fees offset by a $0.6 million increase in
personnel-related costs driven by stock-based compensation and
other benefits.
For the three months ended June 30, 2023, Nuvation Bio reported
a net loss of $20.6 million, or $(0.09) per share. This compares to
a net loss of $34.9 million, or $(0.16) 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 August 3, 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)
June 30,
December 31,
2023
2022
Assets Current assets: Cash and cash equivalents
$
50,065
$
101,099
Prepaid expenses and other current assets
3,531
3,819
Marketable securities
580,835
559,915
Interest receivable on marketable securities
2,795
2,485
Total current assets
637,226
667,318
Property and equipment, net
804
894
Operating lease right-of-use assets
3,242
3,791
Lease security deposit
138
138
Total assets
$
641,410
$
672,141
Liabilities and stockholders' equity Current
liabilities: Accounts payable
$
2,577
$
2,139
Current operating lease liabilities
1,283
1,206
Accrued expenses
9,553
9,816
Total current liabilities
13,413
13,161
Warrant liability
972
850
Non-current operating lease liabilities
2,393
3,054
Total liabilities
16,778
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 June 30, 2023 and December 31, 2022, 218,899,462
(Class A 217,899,462, 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
June 30, 2023 and December 31, 2022, respectively
938,395
927,604
Accumulated deficit
(309,368
)
(267,002
)
Accumulated other comprehensive income
(4,395
)
(5,526
)
Total stockholders' equity
624,632
655,076
Total liabilities and stockholders' equity
$
641,410
$
672,141
NUVATION BIO INC. and Subsidiaries Consolidated
Statements of Operations and Comprehensive Loss (In
thousands, except per share data)
Three Months Ended June
30,
Six Months Ended June
30,
2023
2022
2023
2022
Operating expenses: Research and development
$
18,590
$
28,922
$
37,377
$
49,650
General and administrative
7,541
8,948
15,275
16,411
Total operating expenses
26,131
37,870
52,652
66,061
Loss from operations
(26,131
)
(37,870
)
(52,652
)
(66,061
)
Other income (expense): Interest income
6,086
841
11,065
1,798
Investment advisory fees
(231
)
(215
)
(461
)
(384
)
Change in fair value of warrant liability
(265
)
3,080
(123
)
9,404
Realized loss on marketable securities
(99
)
(694
)
(195
)
(908
)
Total other income (expense), net
5,491
3,012
10,286
9,910
Loss before income taxes
(20,640
)
(34,858
)
(42,366
)
(56,151
)
Provision for income taxes
-
-
-
-
Net loss
$
(20,640
)
$
(34,858
)
$
(42,366
)
$
(56,151
)
Net loss attributable to common stockholders Net loss per
share attributable to common stockholders, basic and diluted
$
(0.09
)
$
(0.16
)
$
(0.19
)
$
(0.26
)
Weighted average common shares outstanding, basic and diluted
218,848
216,603
218,795
215,016
Comprehensive loss: Net loss
$
(20,640
)
$
(34,858
)
$
(42,366
)
$
(56,151
)
Other comprehensive loss, net of taxes: Unrealized (loss) gain on
available-for-sale securities
(1,457
)
(761
)
1,131
(5,793
)
Comprehensive loss
$
(22,097
)
$
(35,619
)
$
(41,235
)
$
(61,944
)
View source
version on businesswire.com: https://www.businesswire.com/news/home/20230803704262/en/
Nuvation Bio Investors: ir@nuvationbio.com
Nuvation Bio Media: nuvation@argotpartners.com
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