Nuvation Bio Reports Third Quarter 2022 Financial Results and Provides Business Update

Rhea-AI Summary

Nuvation Bio Inc. (NYSE: NUVB) announced that dosing is underway in a Phase 1 study of NUV-868 for advanced solid tumors, with a Phase 1b combination study expected to begin by the end of 2022. The company anticipates nominating its first clinical candidate from its Drug-Drug Conjugate platform by year-end. As of September 30, 2022, Nuvation Bio reported a strong financial position with $673.9 million in cash and equivalents. However, the company faced a net loss of $27.2 million for Q3 2022, compared to a net loss of $22 million for Q3 2021.

Positive

• Initiation of Phase 1b combination study of NUV-868 expected by end of 2022.
• Strong cash position of $673.9 million, providing runway through 2028.
• Expected nomination of first clinical candidate from Drug-Drug Conjugate platform by end of 2022.

Negative

• Net loss of $27.2 million for Q3 2022, higher than $22 million in Q3 2021.
• Increased research and development expenses of $21.3 million, up from $17.1 million year-over-year.

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

NEW YORK--(BUSINESS WIRE)-- 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

Source: Nuvation Bio Inc.

FAQ

What are the latest developments for Nuvation Bio's NUV-868?

Nuvation Bio is currently dosing patients in a Phase 1 study of NUV-868 and plans to initiate a Phase 1b combination study by the end of 2022.

What is Nuvation Bio's financial position as of September 30, 2022?

Nuvation Bio reported $673.9 million in cash, cash equivalents, and marketable securities, sufficient to sustain operations through 2028.

What were Nuvation Bio's Q3 2022 financial results?

Nuvation Bio reported a net loss of $27.2 million, or $(0.12) per share, compared to a $22 million net loss in Q3 2021.

When can we expect the nomination of a new clinical candidate from Nuvation Bio?

Nuvation Bio expects to nominate its first clinical candidate from its Drug-Drug Conjugate platform by the end of 2022.