8-K
Nuvation Bio Inc. (NUVB)
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): November 10, 2021
Nuvation Bio Inc.
(Exact name of registrant as specified in its charter)
| Delaware | 001-39351 | 85-0862255 |
|---|---|---|
| (State or other jurisdiction<br> <br>of incorporation) | (Commission<br> <br>File Number) | (I.R.S. Employer<br> <br>Identification No.) |
1500 Broadway, Suite 1401
New York, NY 10036
(Address of principal executive offices)
(332) 208-6102
(Registrant’s telephone number, including area code)
Check the appropriate box below if the Form 8-K filing is intended to simultaneously satisfy the filing obligation 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 Exchange Act (17 CFR 240.13e-4(c)) |
| --- | --- |
Securities registered pursuant to Section 12(b) of the Act:
| Title of each class registered | Trading<br> <br>Symbol(s) | Name of each exchange<br> <br>on which |
|---|---|---|
| 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 November 10, 2021, Nuvation Bio Inc. issued a press release announcing its financial results for the quarter ended September 30, 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 |
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(d) Exhibits.
| Exhibit<br>Number | Description |
|---|---|
| 99.1 | Press Release of Nuvation Bio Inc. dated November 10, 2021. |
| 104 | Cover Page Interactive Data File (embedded within XBRL document) |
2
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.
| Dated: November 10, 2021 | NUVATION BIO INC. | |
|---|---|---|
| By: | /s/ Jennifer Fox | |
| Name: | Jennifer Fox | |
| Title: | Chief Financial Officer |
3
EX-99.1
Exhibit 99.1
Nuvation Bio Reports Third Quarter 2021 Financial Results and Provides Business Update
Enrollment ongoing in phase 1/2 study of NUV-422 for the treatment of multiple difficult-to-treat cancers
Strong balance sheet withcash, cash equivalents and marketable securities of $791.8 million as of September 30, 2021
New York, Nov. 10, 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 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 ofNUV-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<br>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<br>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)
| December 31,2020 | |||||
|---|---|---|---|---|---|
| Assets | |||||
| Current assets: | |||||
| Cash and cash equivalents | 344,631 | $ | 29,755 | ||
| Prepaid expenses | 3,014 | 914 | |||
| Marketable securities<br>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<br>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<br>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<br>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 |
All values are in US Dollars.
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 | ) |