Full Press Release Details
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 with
cash, 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
Second Quarter Financial Results
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
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.
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:
Nuvation Bio Media Contact:
NUVATION BIO INC. and Subsidiaries
Condensed Balance Sheets
(In thousands, except share and
| September 30, 2021 | December 31, 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 | ) |