Nuvation Bio Reports Third Quarter 2021 Financial Results and Provides Business Update

Rhea-AI Summary

Nuvation Bio Inc. (NYSE: NUVB) reported Q3 financial results, showing a net loss of $22.0 million, or $(0.11) per share, compared to a net loss of $11.0 million, or $(0.12) per share in Q3 2020. R&D expenses surged to $17.1 million from $8.6 million due to increased research services and personnel costs. G&A expenses also rose to $5.7 million from $2.9 million. As of September 30, 2021, the company had $791.8 million in cash and marketable securities. Nuvation is advancing its CDK inhibitor program NUV-422, with top-line data expected in 2022.

Positive

• Well-capitalized with $791.8 million in cash and marketable securities.
• Advancing the NUV-422 program with ongoing Phase 1/2 study.
• Top-line data from the Phase 1 study expected in 2022.

Negative

• Increased net loss of $22.0 million compared to $11.0 million in Q3 2020.
• R&D expenses increased by 99% year-over-year.

NEW YORK, Nov. 10, 2021 /PRNewswire/ -- 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 third quarter ended September 30, 2021, and provided a business update.

"In the third quarter, Nuvation Bio continued to advance our lead cyclin-dependent kinase (CDK) 2/4/6 inhibitor program, with enrollment progressing in the ongoing Phase 1/2 study of NUV-422 for the treatment of adult patients with recurrent glioblastoma, malignant gliomas, hormone receptor-positive breast cancer and metastatic castration-resistant prostate cancer. We remain on track to report top-line data from the Phase 1 portion of the study in 2022," said David Hung, M.D., founder and chief executive officer of Nuvation Bio. "Additionally, we remain well capitalized to advance our full pipeline of novel oncology therapeutic candidates for difficult-to-treat cancers and look forward to providing clinical development updates."

Recent Business Highlights

• Enrollment ongoing in Phase 1/2 multiple expansion cohort study of NUV-422. During the third quarter of 2021, Nuvation Bio continued to enroll patients in the Phase 1/2 study of NUV-422, a CDK 2/4/6 inhibitor. The Company submitted a protocol amendment to the U.S. Food and Drug Administration (FDA) in the second quarter, expanding the study to include additional cohorts for patients with recurrent glioblastoma, hormone receptor-positive metastatic breast cancer (with and without brain metastases) and metastatic castration-resistant prostate cancer. Enrollment is ongoing and data from the Phase 1 portion of the study is expected in 2022.

Second Quarter Financial Results

As of September 30, 2021, Nuvation Bio had cash, cash equivalents and marketable securities of $791.8 million.

For the three months ended September 30, 2021, research and development expenses were $17.1 million, compared to $8.6 million for the three months ended September 30, 2020. The increase was primarily due to a $5.3 million increase in third-party costs related to research services and manufacturing to advance our current preclinical programs and Phase 1/2 clinical trial, as well as a $3.2 million increase in personnel-related costs driven by an increase in headcount and stock-based compensation.

For the three months ended September 30, 2021, general and administrative expenses were $5.7 million, compared to $2.9 million for the three months ended September 30, 2020. 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 $1.1 million increase in insurance, a $0.3 million increase in other miscellaneous expenses offset by a $0.4 million decrease in professional fees and a $0.1 million decrease in legal fees.

For the three months ended September 30, 2021, Nuvation Bio reported a net loss of $22.0 million, or $(0.11) per share. This compares to a net loss of $11.0 million, or $(0.12) per share, for the comparable period in 2020.

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 six novel and 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 data. 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 provided for illustrative purposes only and are not intended to serve as, and must not be relied on as, a guarantee, an assurance, a prediction or a definitive statement of fact or probability. Actual events and circumstances are difficult or impossible to predict and will differ from assumptions. Many actual events and circumstances are beyond the control of Nuvation Bio. These forward-looking statements are subject to a number of risks and uncertainties, including those factors discussed in the Quarterly Report on Form 10-Q expected to be filed with the SEC on or about November 11, 2021, under the heading "Risk Factors," and other documents that Nuvation Bio has filed or will file with the SEC. If any of these risks materialize or Nuvation Bio's assumptions prove incorrect, actual results could differ materially from the results implied by these forward-looking statements. There may be additional risks that Nuvation Bio does not presently know, or that Nuvation Bio currently believes are immaterial, that could also cause actual results to differ from those contained in the forward-looking statements. In addition, forward-looking statements reflect Nuvation Bio's expectations, plans or forecasts of future events and views as of the date of this press release. Nuvation Bio anticipates that subsequent events and developments will cause Nuvation Bio's assessments to change. However, while Nuvation Bio may elect to update these forward-looking statements at some point in the future, Nuvation Bio specifically disclaims any obligation to do so. These forward-looking statements should not be relied upon as representing Nuvation Bio's assessments of any date subsequent to the date of this press release. Accordingly, undue reliance should not be placed upon the forward-looking statements.

Nuvation Bio Investor Contact:
ir@nuvationbio.com

Nuvation Bio Media Contact:
Argot Partners
Leo Vartorella
leo@argotpartners.com 

 

NUVATION BIO INC. and Subsidiaries
Condensed Balance Sheets
(In thousands, except share and per share data)	September 30,		December 31,
	2021		2020
Assets
Current assets:
Cash and cash equivalents	$      344,631		$        29,755
Prepaid expenses	3,014		914
Marketable securities available-for-sale, at fair value	447,153		185,997
Interest receivable on marketable securities	1,814		1,092
Deferred financing costs	-		2,925
Total current assets	796,612		220,683
Property and equipment, net	758		688
Other assets:
Lease security deposit	421		421
Total assets	$      797,791		$      221,792
Liabilities and stockholders' equity
Current liabilities:
Accounts payable	$          5,163		$          2,171
Accrued expenses	8,145		4,380
Total current liabilities	13,308		6,551
Warrant liability	14,936		-
Deferred rent - non current	181		157
Total liabilities	28,425		6,708
Commitments and contingencies (Note 11)
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 June 30, 2021 (Class A 1,000,000,000, Class B 60,000,000)
and 1,174,094,678 shares authorized as of December 31, 2020 (Class A 880,000,000, Class B 294,094,678);
217,776,232 (Class A 216,776,232, Class B 1,000,000) and 149,042,155 (Class A 91,397,142,
Class B 57,645,013) issued and outstanding as of September 30, 2021 and December 31, 2020, respectively	906,647		289,482
Accumulated deficit	(137,669)		(75,955)
Accumulated other comprehensive income	388		1,557
Total stockholders' equity	769,366		215,084
Total liabilities and stockholders' equity	$      797,791		$      221,792

 

 

NUVATION BIO INC. and Subsidiaries
Condensed Statements of Operations and Comprehensive Loss
(In thousands, except per share data)
	Three Months Ended September 30,				Nine Months Ended September 30,
	2021		2020		2021		2020
Operating expenses:
Research and development	$            17,122		$              8,627		$            47,035		$            23,267
General and administrative	5,669		2,919		16,674		6,516
Total operating expenses	22,791		11,546		63,709		29,783
Loss from operations	(22,791)		(11,546)		(63,709)		(29,783)
Other income (expense):
Interest income	847		445		2,061		1,486
Investment advisory fees	(170)		(52)		(454)		(168)
Change in fair value of warrant liability	125		-		332		-
Realized gain (loss) on marketable securities	10		119		56		86
Total other (expense) income	812		512		1,995		1,404
Loss before income taxes	(21,979)		(11,034)		(61,714)		(28,379)
Provision for income taxes	-		-		-		-
Net loss	$           (21,979)		$           (11,034)		$           (61,714)		$           (28,379)
Net loss attributable to common stockholders
Net loss per share attributable to common stockholders, basic and diluted	$               (0.11)		$               (0.12)		$               (0.32)		$               (0.32)
Weighted average common shares outstanding, basic and diluted	207,101		91,771		193,730		88,755
Comprehensive loss:
Net loss	$           (21,979)		$           (11,034)		$           (61,714)		$           (28,379)
Other comprehensive income, net of taxes:
Change in unrealized (loss) gain on available-for-sale securities	(369)		(350)		(1,169)		1,400
Comprehensive loss	$           (22,348)		$           (11,384)		$           (62,883)		$           (26,979)

 

 

 

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SOURCE Nuvation Bio, Inc.

FAQ

What were Nuvation Bio's Q3 earnings results for 2021?

Nuvation Bio reported a net loss of $22.0 million, or $(0.11) per share for Q3 2021.

What is NUV-422 and its significance for Nuvation Bio?

NUV-422 is a CDK 2/4/6 inhibitor being studied for various cancers, with top-line data expected in 2022.

How much cash did Nuvation Bio have as of September 30, 2021?

Nuvation Bio had $791.8 million in cash, cash equivalents, and marketable securities as of September 30, 2021.