Form 8-K Nuvation Bio Inc. For: May 17

 

 

UNITED STATES

SECURITIES AND EXCHANGE COMMISSION

Washington, D.C. 20549

 

 

FORM 8-K

 

 

CURRENT REPORT

Pursuant to Section 13 or 15(d)

of the Securities Exchange Act of 1934

Date of Report (Date of earliest event reported): May 17, 2021

 

 

Nuvation Bio Inc.

(Exact name of registrant as specified in its charter)

 

 

 

Delaware		001-39351		85-0862255
(State or other jurisdiction of incorporation)		(Commission File Number)		(IRS Employer Identification No.)

 

1500 Broadway, Suite 1401 New York, NY		10036
(Address of principal executive offices)		(Zip Code)

Registrant’s telephone number, including area code: (332) 208-6102

 

 

Check the appropriate box below if the Form 8-K filing is intended to simultaneously satisfy the filing obligations of the registrant under any of the following provisions:

 

☐	Written communications pursuant to Rule 425 under the Securities Act (17 CFR 230.425)

 

☐	Soliciting material pursuant to Rule 14a-12 under the Exchange Act (17 CFR 240.14a-12)

 

☐	Pre-commencement communications pursuant to Rule 14d-2(b) under the Exchange Act (17 CFR 240.14d-2(b))

 

☐	Pre-commencement communications pursuant to Rule 13e-4(c) under the Exchange Act (17 CFR 240.13e-4(c))

Securities registered pursuant to Section 12(b) of the Act:

 

Title of each class		Trading Symbol(s)		Name of each exchange on which registered
Class A Common Stock, $0.0001 par value per share		NUVB		The New York Stock Exchange
Redeemable Warrants, each whole warrant exercisable for one share of Common Stock at an exercise price of $11.50 per share		NUVB.WS		The New York Stock Exchange

Indicate by check mark whether the registrant is an emerging growth company as defined in Rule 405 of the Securities Act of 1933 (§230.405 of this chapter) or Rule 12b-2 of the Securities Exchange Act of 1934 (§240.12b-2 of this chapter).

Emerging growth company  ☒

If an emerging growth company, indicate by check mark if the registrant has elected not to use the extended transition period for complying with any new or revised financial accounting standards provided pursuant to Section 13(a) of the Exchange Act.  ☐

 

 

 

Item 2.02.

Results of Operations and Financial Condition.

On May 17, 2021, Nuvation Bio Inc. issued a press release announcing its financial results for the quarter ended March 31, 2021. A copy of the press release is furnished as Exhibit 99.1 to this Form 8-K.

The information contained in this Form 8-K, including in the accompanying Exhibit 99.1, shall not be deemed filed for purposes of Section 18 of the Securities Exchange Act of 1934, as amended, or incorporated by reference in any filing under the Exchange Act or the Securities Act of 1933, as amended, except as shall be expressly set forth by specific reference in such filing.

 

Item 9.01.

Financial Statements and Exhibits.

(d) Exhibits.

 

Exhibit No.		Description
99.1		Press Release of Nuvation Bio Inc. dated May 17, 2021.

SIGNATURES

Pursuant to the requirements of the Securities Exchange Act of 1934, as amended, the registrant has duly caused this report to be signed on its behalf by the undersigned hereunto duly authorized.

 

				NUVATION BIO INC.
Date: May 17, 2021				By:		/s/ Jennifer Fox
						Name: Jennifer Fox
						Title: Chief Financial Officer

Exhibit 99.1

 

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

Ongoing enrollment in Phase 1/2 study of NUV-422 in high-grade gliomas

Strong balance sheet with cash, cash equivalents and marketable securities of

$824.7million as of March 31, 2021

Previously issued 2020 financial statements of Panacea Acquisition Corp. being

restated based on recent SEC guidance

NEW YORK – May 17, 2021 – 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 first quarter ended March 31, 2021, and provided a business update.

“Nuvation Bio continues to make meaningful progress on advancing our deep pipeline of therapies for difficult-to-treat cancers and remains on track to submit five additional Investigational New Drug (IND) applications by 2026,” said David Hung, M.D., founder and chief executive officer of Nuvation Bio. “We also continue to enroll and dose patients in our Phase 1/2 study of NUV-422, our lead cyclin-dependent kinase (CDK) 2/4/6 inhibitor, in high-grade gliomas and expect top-line data from the Phase 1 portion of this study in 2022. Our strong cash, cash equivalents and marketable securities of $824.7 million at the end of the first quarter provides us sufficient resources to continue to execute on our robust clinical development plan and grow our pipeline of novel and mechanistically distinct cancer treatments.”

Recent Business Highlights

 

•

Enrollment ongoing in Phase 1/2 study of NUV-422. Nuvation Bio continues to enroll and dose patients in the Phase 1/2 study of its lead investigational compound, NUV-422, a CDK 2/4/6 inhibitor, in adult patients with recurrent or refractory high-grade gliomas, including glioblastoma multiforme (GBM). The Phase 1 dose escalation portion of the study is designed to evaluate safety and tolerability, as well as to determine a recommended Phase 2 dose based on the tolerability profile and pharmacokinetic properties of NUV-422. The Phase 2 dose expansion portion of the study is expected to initially focus on patients with high-grade gliomas and is designed to evaluate overall response rate, duration of response and survival. Data from the Phase 1 portion of this study is expected in 2022.

First Quarter 2021 Financial Results

As of March 31, 2021, Nuvation Bio had cash, cash equivalents, and marketable securities of $824.7 million.

For the three months ended March 31, 2021, research and development expenses were $15.9 million, compared to $7.3 million for the three months ended March 31, 2020. The increase of $8.6 million was due to an increase in third-party costs related to research services and manufacturing to advance our current preclinical programs and Phase 1/2 clinical trial. Also, the current period includes approximately $3.7 million related to the issuance of common stock as consideration for the purchase of in-process research and development.

For the three months ended March 31, 2021, general and administrative expenses were $4.6 million, compared to $1.9 million for the three months ended March 31, 2020. The increase of $2.7 million was due to increased personnel-related costs driven by an increase in headcount, as well as increases in professional fees, insurance costs and tax expense.

For the three months ended March 31, 2021, Nuvation Bio reported a net loss of $20.4 million, or $(0.12) per share. This compares to a net loss of $8.7 million, or $(0.10) per share, for the comparable period in 2020.

Restatement of Panacea Financial Statements

Nuvation Bio also announced that, as reported in a Current Report on Form 8-K filed with the SEC on May 14, 2021, as a result of guidance provided by the SEC on April 12, 2021 regarding the accounting for warrants issued by special purpose acquisition companies (SPACs), it is restating the previously issued 2020 consolidated financial statements of Panacea Acquisition Corp. (Panacea). Panacea combined with Nuvation Bio Inc. (Legacy Nuvation Bio) and changed its name to Nuvation Bio Inc. on February 10, 2021 (the Merger).

The restatement pertains to the accounting treatment for Panacea’s public and private placement warrants that were outstanding on December 31, 2020, as well as the forward purchase agreement (the “FPA”) with certain anchor investors, which provided for the potential future issuance of securities, including additional warrants. Consistent with market practice among SPACs, Panacea had been accounting for the warrants and the FPA as equity under a fixed accounting model. However, in light of the recent SEC guidance, we are restating Panacea’s historical financial statements for the year ended December 31, 2020 such that the warrants and the FPA are accounted for as liabilities and marked-to-market each reporting period. In general, under the mark-to-market accounting model, we measure the fair value of the liability-classified warrants and the FPA at the end of each reporting period and recognize any changes in their fair value in our operating results. As of December 31, 2020, Panacea had 4,954,167 warrants outstanding and subject to reclassification. Upon completion of the Merger, an additional 833,333 warrants were issued pursuant to the FPA.

The change in accounting treatment does not impact the historical financial statements of Legacy Nuvation Bio, which became the historical financial statements of the combined company upon completion of the Merger. In addition, Nuvation Bio currently expects that the reclassification of the warrants will have no impact on the liquidity or cash or cash equivalents in the historical financial statements of Panacea.

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 potential therapeutic benefit of Nuvation Bio’s product candidates, expected future IND filings, the expected timing of clinical trial data and the expected impact of the restatement of Panacea’s 2020 financial statements. 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. Forward-looking statements are subject to a number of risks and uncertainties, including those factors discussed in the Quarterly Report on Form 10-Q filed with the SEC on or about May 17, 2021, in the section titled “Item 1A. 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:

[email protected]

Nuvation Bio Media Contact:

Argot Partners

Leo Vartorella

[email protected]

NUVATION BIO INC. and Subsidiaries

Condensed Balance Sheets

(In thousands, except share and per share data)

 

		March 31, 2021				December 31, 2020
Assets
Current assets:
Cash and cash equivalents		$	638,904			$	29,755
Prepaid expenses			5,138				914
Marketable securities available-for-sale, at fair value			185,809				185,997
Interest receivable on marketable securities			1,015				1,092
Deferred financing costs			—				2,925
Total current assets			830,866				220,683
Property and equipment, net			772				688
Other assets:
Lease security deposit			421				421
Total assets		$	832,059			$	221,792
Liabilities and stockholders’ equity
Current liabilities:
Accounts payable		$	6,003			$	2,171
Accrued expenses			3,984				4,380
Total current liabilities			9,987				6,551
Warrant liability			15,561				—
Deferred rent - non current			167				157
Total liabilities			25,715				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 March 31, 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); 217,650,055 (Class A 216,650,055, Class B 1,000,000) and 149,042,155 (Class A 91,397,142, Class B 57,645,013) issued and outstanding as of March 31, 2021 and December 31, 2020, respectively			901,720				289,482
Accumulated deficit			(96,357	)			(75,955	)
Accumulated other comprehensive income			981				1,557
Total stockholders’ equity			806,344				215,084
Total liabilities and stockholders’ equity		$	832,059			$	221,792

NUVATION BIO INC. and Subsidiaries

Condensed Statements of Operations and Comprehensive Loss

(In thousands, except share and per share data)

 

For The Three Months Ended March 31,		2021				2020
Operating expenses:
Research and development		$	15,879			$	7,295
General and administrative			4,605				1,925
Total operating expenses			20,484				9,220
Loss from operations			(20,484	)			(9,220	)
Other income (expense):
Interest income			438				519
Investment advisory fees			(108	)			(60	)
Change in fair value of warrant liability			(293	)			—
Realized gain on marketable securities			45				15
Total other income (expense)			82				474
Loss before income taxes			(20,402	)			(8,746	)
Provision for income taxes			—				—
Net loss		$	(20,402	)		$	(8,746	)
Net loss attributable to common stockholders
Net loss per share attributable to common stockholders, basic and diluted		$	(0.12	)		$	(0.10	)
Weighted average common shares outstanding, basic and diluted			169,659,037				85,714,375
Comprehensive loss:
Net loss		$	(20,402	)		$	(8,746	)
Other comprehensive income, net of taxes:
Change in unrealized (loss) gain on available-for-sale securities			(576	)			819
Comprehensive loss		$	(20,978	)		$	(7,927	)