Dosing underway for Phase 1 monotherapy study
of NUV-868 in advanced solid tumors
Expect to initiate Phase 1b combination study
of NUV-868 by the end of 2022
On track to nominate first clinical candidate
from Drug-Drug Conjugate (DDC) platform by the end of 2022
Strong financial position provides cash runway
through 2028; cash, cash equivalents and marketable securities of
$673.9 million as of September 30, 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 its
financial results for the third quarter ended September 30, 2022,
and provided a business update.
“We are encouraged by the continued clinical progress of NUV-868
and look forward to the initiation of Phase 1b combination cohorts
later this year, which we anticipate will provide better
understanding of the potential benefit this therapy can offer a
wide range of patients with advanced solid tumors,” said David
Hung, M.D., Founder, President and Chief Executive Officer of
Nuvation Bio. “We also expect to nominate the first clinical
candidate from our DDC platform by the end of 2022, underscoring
the growth-driving capabilities of this platform as we work to
tackle some of the greatest unmet needs in oncology.”
Recent Business Updates
NUV-868, BD2-Selective BETi: Advanced solid
tumors
- Dosing ongoing in the Phase 1 monotherapy study of
NUV-868. Nuvation Bio continues to enroll the Phase 1
monotherapy study in advanced solid tumors. The Company expects to
initiate the Phase 1b study of NUV-868 in combination with olaparib
in ovarian, pancreatic, metastatic castration-resistant prostate
and triple negative breast cancers, or in combination with
enzalutamide in metastatic castration-resistant prostate cancer, by
the end of 2022.
Drug-Drug Conjugate Platform: Solid tumors
- Nomination of first clinical candidate from the DDC
platform is expected by the end of 2022.
Third Quarter 2022 Financial Results
As of September 30, 2022, Nuvation Bio had cash, cash
equivalents and marketable securities of $673.9 million.
For the three months ended September 30, 2022, research and
development expenses were $21.3 million, compared to $17.1 million
for the three months ended September 30, 2021. The increase was
primarily due to restructuring costs of $1.6 million related to
severance and benefit costs and $5.7 million related to contract
termination costs offset by $2.8 million decrease in third-party
costs related to research services and manufacturing, as well as a
$0.3 million decrease in personnel-related costs driven by the
termination of the NUV-422 program.
For the three months ended September 30, 2022, general and
administrative expenses were $8.0 million, compared to $5.7 million
for the three months ended September 30, 2021. The increase was
primarily due to a $1.9 million increase in personnel-related costs
driven by an increase in headcount and stock-based compensation, a
$0.2 million increase in occupancy expenses, a $0.1 million
increase in professional fees, and a $0.1 million of restructuring
costs related to severance and benefit costs.
For the three months ended September 30, 2022, Nuvation Bio
reported a net loss of $27.2 million, or $(0.12) per share. This
compares to a net loss of $22.0 million, or $(0.11) per share, for
the comparable period in 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 expected timing of clinical trial
initiation, the expected timing of clinical candidate nomination
from the DDC platform, Nuvation Bio’s cash runway and the potential
therapeutic benefit of its product candidates. 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;
risks related to cost reduction efforts; 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
or about November 3, 2022, 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,
2022
2021
Assets Current
assets: Cash and cash equivalents
$
138,690
$
132,423
Prepaid expenses and other current assets
5,094
3,642
Marketable securities
535,255
632,969
Interest receivable on marketable securities
2,350
3,039
Total current assets
681,389
772,073
Property and equipment, net
902
786
Operating lease right-of-use assets
4,060
2,871
Lease security deposit
138
421
Total assets
$
686,489
$
776,151
Liabilities and stockholders' equity
Current liabilities: Accounts
payable
$
2,995
$
3,925
Current operating lease liabilities
1,100
863
Accrued expenses
9,916
12,137
Total current liabilities
14,011
16,925
Warrant liability
1,171
11,037
Non-current operating lease liabilities
3,372
2,192
Total liabilities
18,554
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
(Class A 1,000,000,000, Class B 60,000,000) shares authorized as of
September 30, 2022 and December 31, 2021,
218,392,607 (Class A 217,392,607, Class B 1,000,000) and
217,948,568 (Class A 216,948,568, Class B 1,000,000)
shares issued and outstanding as of September 30, 2022 and
December 31, 2021, respectively
922,209
909,985
Accumulated deficit
(246,157
)
(162,803
)
Accumulated other comprehensive income
(8,117
)
(1,185
)
Total stockholders' equity
667,935
745,997
Total liabilities and stockholders' equity
$
686,489
$
776,151
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,
2022
2021
2022
2021
Operating expenses: Research and
development
$
21,294
$
17,122
$
70,944
$
47,035
General and administrative
8,044
5,669
24,455
16,674
Total operating expenses
29,338
22,791
95,399
63,709
Loss from operations
(29,338
)
(22,791
)
(95,399
)
(63,709
)
Other income (expense): Interest income
2,127
847
3,925
2,061
Investment advisory fees
(263
)
(170
)
(647
)
(454
)
Change in fair value of warrant liability
462
125
9,866
332
Realized (loss) gain on marketable securities
(191
)
10
(1,099
)
56
Total other (expense) income, net
2,135
812
12,045
1,995
Loss before income taxes
(27,203
)
(21,979
)
(83,354
)
(61,714
)
Provision for income taxes
-
-
-
-
Net loss
$
(27,203
)
$
(21,979
)
$
(83,354
)
$
(61,714
)
Net loss attributable to common stockholders
Net loss per share attributable to common
stockholders, basic and diluted
$
(0.12
)
$
(0.11
)
$
(0.39
)
$
(0.32
)
Weighted average common shares outstanding, basic and diluted
218,300
207,101
216,123
193,730
Comprehensive loss: Net loss
$
(27,203
)
$
(21,979
)
$
(83,354
)
$
(61,714
)
Other comprehensive income, net of taxes: Unrealized loss on
available-for-sale securities
(1,139
)
(369
)
(6,932
)
(1,169
)
Comprehensive loss
$
(28,342
)
$
(22,348
)
$
(90,286
)
$
(62,883
)
View source
version on businesswire.com: https://www.businesswire.com/news/home/20221103005132/en/
Nuvation Bio Investor Contact: ir@nuvationbio.com
Nuvation Bio Media Contact: Argot Partners Leo Vartorella
leo@argotpartners.com
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