Full Press Release Details
Nuvation Bio Reports Second Quarter 2021 Financial Results and Provides Business Update
Ongoing enrollment in Phase 1/2 study of lead investigational compound NUV-422 for the treatment of
adult patients with malignant gliomas; protocol amendment submitted to expand into additional cancers
Strong balance sheet with
cash, cash equivalents and marketable securities of $806.6 million as of June 30, 2021
NEW YORK, August 12, 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 second
quarter ended June 30, 2021, and provided a business update.
The second quarter of 2021 marked multiple achievements for Nuvation Bio. With
the appointment of David C. Hanley, Ph.D., as Chief Technical Operations Officer, we are advancing our supply chain, product development and manufacturing efforts. For our pipeline, we continue to enroll and dose patients in our ongoing Phase 1/2
study of NUV-422 and have recently expanded the study to include additional cohorts for patients with recurrent glioblastoma, hormone receptor-positive breast cancer and metastatic castration-resistant
prostate cancer, further reinforcing the potential of NUV-422, said David Hung, M.D., founder and chief executive officer of Nuvation Bio. We look forward to advancing our ongoing study of NUV-422, and the entirety of our pipeline of therapies for difficult-to-treat cancers, towards clinical development.
Recent Business Highlights
Second Quarter Financial Results
As of June 30, 2021, Nuvation Bio had cash, cash equivalents and marketable securities of $806.6 million.
For the three months ended June 30, 2021, research and development expenses were $14.0 million, compared to $7.3 million for the three months
ended June 30, 2020. The increase of $6.7 million was primarily due to a $4.7 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 $2.0 million increase in personnel-related costs driven by an increase in headcount and stock-based compensation.
months ended June 30, 2021, general and administrative expenses were $6.4 million, compared to $1.7 million for the three months ended June 30, 2020. The increase of $4.7 million was due to an increase in personnel-related
costs driven by an increase in headcount and stock-based compensation, as well as increases in insurance, professional fees, other miscellaneous expenses and legal fees.
For the three months ended June 30, 2021, Nuvation Bio reported a net loss of $19.3 million, or $(0.09) per share. This compares to a net loss of
$8.6 million, or $(0.10) 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 potential therapeutic benefit of Nuvation
Bio s product candidates and 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 filed with the SEC on August 12, 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
| June 30, 2021 | December 31, 2020 | |||||||
| Assets | ||||||||
| Current assets: | ||||||||
| Cash and cash equivalents | $ | 449,533 | $ | 29,755 | ||||
| Prepaid expenses | 4,472 | 914 | ||||||
| Marketable securities available-for-sale, at fair value | 357,074 | 185,997 | ||||||
| Interest receivable on marketable securities | 1,997 | 1,092 | ||||||
| Deferred financing costs | 2,925 | |||||||
| Total current assets | 813,076 | 220,683 | ||||||
| Property and equipment, net | 766 | 688 | ||||||
| Other assets: | ||||||||
| Lease security deposit | 421 | 421 | ||||||
| Total assets | $ | 814,263 | $ | 221,792 | ||||
| Liabilities and stockholders equity | ||||||||
| Current liabilities: | ||||||||
| Accounts payable | $ | 4,497 | $ | 2,171 | ||||
| Accrued expenses | 5,593 | 4,380 | ||||||
| Total current liabilities | 10,090 | 6,551 | ||||||
| Warrant liability | 15,061 | |||||||
| Deferred rent - non current | 177 | 157 | ||||||
| Total liabilities | 25,328 | 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); 217,759,082 (Class A 216,759,082, Class B 1,000,000) and 149,042,155 (Class A 91,397,142, Class B 57,645,013) issued and outstanding as of June 30, 2021 and December 31, 2020, respectively | 903,868 | 289,482 | ||||||
| Accumulated deficit | (115,690 | ) | (75,955 | ) | ||||
| Accumulated other comprehensive income | 757 | 1,557 | ||||||
| Total stockholders equity | 788,935 | 215,084 | ||||||
| Total liabilities and stockholders equity | $ | 814,263 | $ | 221,792 |
NUVATION BIO INC. and Subsidiaries
Condensed Statements of Operations and Comprehensive Loss
(In thousands, except per share data)
| Three Months Ended June 30, | Six Months Ended June 30, | |||||||||||||||
| 2021 | 2020 | 2021 | 2020 | |||||||||||||
| Operating expenses: | ||||||||||||||||
| Research and development | $ | 14,034 | $ | 7,345 | $ | 29,913 | $ | 14,640 | ||||||||
| General and administrative | 6,400 | 1,672 | 11,005 | 3,597 | ||||||||||||
| Total operating expenses | 20,434 | 9,017 | 40,918 | 18,237 | ||||||||||||
| Loss from operations | (20,434 | ) | (9,017 | ) | (40,918 | ) | (18,237 | ) | ||||||||
| Other income (expense): | ||||||||||||||||
| Interest income | 776 | 522 | 1,214 | 1,041 | ||||||||||||
| Investment advisory fees | (176 | ) | (56 | ) | (284 | ) | (116 | ) | ||||||||
| Change in fair value of warrant liability | 500 | 207 | ||||||||||||||
| Realized gain (loss) on marketable securities | 1 | (48 | ) | 46 | (33 | ) | ||||||||||
| Total other (expense) income | 1,101 | 418 | 1,183 | 892 | ||||||||||||
| Loss before income taxes | (19,333 | ) | (8,599 | ) | (39,735 | ) | (17,345 | ) | ||||||||
| Provision for income taxes | ||||||||||||||||
| Net loss | $ | (19,333 | ) | $ | (8,599 | ) | $ | (39,735 | ) | $ | (17,345 | ) | ||||
| Net loss attributable to common stockholders | ||||||||||||||||
| Net loss per share attributable to common stockholders, basic and diluted | $ | (0.09 | ) | $ | (0.10 | ) | $ | (0.21 | ) | $ | (0.20 | ) | ||||
| Weighted average common shares outstanding, basic and diluted | 204,017 | 88,745 | 186,933 | 87,230 | ||||||||||||
| Comprehensive loss: | ||||||||||||||||
| Net loss | $ | (19,333 | ) | $ | (8,599 | ) | $ | (39,735 | ) | $ | (17,345 | ) | ||||
| Other comprehensive income, net of taxes: | ||||||||||||||||
| Change in unrealized (loss) gain on available-for-sale securities | (224 | ) | 931 | (800 | ) | 1,750 | ||||||||||
| Comprehensive loss | $ | (19,557 | ) | $ | (7,668 | ) | $ | (40,535 | ) | $ | (15,595 | ) |