Full Press Release Details
Nuvation Bio Reports First Quarter 2024 Financial Results and Provides Business Update
Acquisition of AnHeart Therapeutics transformed Nuvation Bio into a late-stage, global oncology company with potential to become a
commercial organization by the end of 2025
Updated data from the pivotal Phase 2 TRUST-I
clinical study of taletrectinib, a ROS1 inhibitor, to be presented at the 2024 American Society of Clinical Oncology (ASCO) Annual Meeting
First patient treated in a Phase 1/2 study of NUV-1511, the company s first drug-drug conjugate
(DDC) to enter the clinic, for the treatment of various advanced solid tumors
Strong balance sheet with cash, cash equivalents, and
marketable securities of $597.0 million as of March 31, 2024
New York, May 14, 2024 Nuvation Bio Inc.
(NYSE: NUVB), a late-stage, global biopharmaceutical company tackling some of the greatest unmet needs in oncology by developing differentiated and novel therapeutic candidates, today reported financial results for the first quarter ended
March 31, 2024, and provided a business update.
The first quarter of 2024 included multiple significant events for Nuvation Bio. We announced
and subsequently completed the acquisition of AnHeart Therapeutics, which transformed Nuvation Bio into a late-stage, global company developing multiple clinical programs for some of the most difficult-to-treat cancers. We also treated the first patient in a Phase 1/2 study of NUV-1511, our first DDC to enter the clinic, said David Hung, M.D., Founder,
President, and Chief Executive Officer of Nuvation Bio. With our robust cash balance and the recent appointment of Colleen Sjogren as our Chief Commercial Officer, along with some new key hires and the integration of new colleagues from
AnHeart, we are thoughtfully scaling our organization to execute on our goal of potentially becoming a commercial organization by the end of 2025, while continuing to advance multiple internal programs in various stages of preclinical and clinical
Recent Pipeline Updates:
Taletrectinib, ROS1 inhibitor: Advanced ROS1-positive non-small cell lung cancer (NSCLC)
mIDH1 inhibitor: Grades 2 and 3 IDH1-mutant glioma
NUV-868, BD2-selective
BET inhibitor: Advanced solid tumors
NUV-1511, DDC: Advanced solid tumors
First Quarter 2024 Financial Results
As of March 31, 2024, Nuvation Bio had cash, cash equivalents and marketable securities of $597.0 million.
For the three months ended March 31, 2024, research and development expenses were $12.8 million, compared to $18.8 million for the three months
ended March 31, 2023. The decrease was primarily due to a $6.7 million decrease in third-party research services and drug manufacturing costs as a result of completing the Phase 1 monotherapy study of
NUV-868, offset by a $0.7 million increase in personnel-related costs driven by stock-based compensation and other benefits.
For the three months ended March 31, 2024, general and administrative expenses were $7.3 million, compared to $7.7 million for the three months
ended March 31, 2023. The decrease was due to a $0.5 million decrease in professional fees, $0.4 million decrease in insurance, and a $0.2 million decrease in personnel-related costs, offset by a $0.4 million increase in
legal fees, a $0.2 million increase in occupancy expense, and a $0.1 million increase in miscellaneous expense.
For the three months ended
March 31, 2024, Nuvation Bio reported a net loss of $14.8 million, or $(0.07) per share. This compares to a net loss of $21.7 million, or $(0.10) per share, for the comparable period in 2023.
Nuvation Bio is a late-stage, global
biopharmaceutical company tackling some of the greatest unmet needs in oncology by developing differentiated and novel therapeutic candidates. Nuvation Bio s portfolio of development candidates includes taletrectinib (ROS1), safusidenib
(mIDH1), NUV-868 (BET), and NUV-1511 (DDC). 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, San Francisco, and Shanghai. For more information, please visit www.nuvationbio.com and
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, the expected timing of becoming a commercial organization, the
potential therapeutic benefit of Nuvation Bio s product candidates, the potential of the DDC platform, the advancement of our preclinical and clinical programs, and the strength of Nuvation Bio s balance sheet. 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
studies 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; and competitive developments. Risks and uncertainties facing Nuvation Bio are described more fully in its Form
10-Q filed with the SEC on May 14, 2024 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 Investor Contact:
Nuvation Bio Media Contact:
NUVATION BIO INC. and Subsidiaries
Condensed Balance Sheets
| (In thousands, except share and per share data) | March 31, 2024 | December 31, 2023 | ||||||
| Assets | ||||||||
| Current assets: | ||||||||
| Cash and cash equivalents | $ | 34,510 | $ | 42,649 | ||||
| Prepaid expenses and other current assets | 6,796 | 1,519 | ||||||
| Marketable securities | 562,466 | 568,564 | ||||||
| Interest receivable on marketable securities | 4,283 | 3,702 | ||||||
| Total current assets | 608,055 | 616,434 | ||||||
| Property and equipment, net | 686 | 717 | ||||||
| Lease security deposit | 141 | 141 | ||||||
| Operating lease right-of-use assets | 3,168 | 3,605 | ||||||
| Other non-current assets | 1,075 | 587 | ||||||
| Total assets | $ | 613,125 | $ | 621,484 | ||||
| Liabilities and stockholders equity | ||||||||
| Current liabilities: | ||||||||
| Accounts payable | $ | 2,436 | $ | 2,209 | ||||
| Current operating lease liabilities | 2,023 | 1,972 | ||||||
| Accrued expenses | 11,303 | 9,793 | ||||||
| Total current liabilities | 15,762 | 13,974 | ||||||
| Warrant liability | 1,812 | 353 | ||||||
| Non-current operating lease liabilities | 1,509 | 2,035 | ||||||
| Total liabilities | 19,083 | 16,362 | ||||||
| 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 March 31, 2024 and December 31, 2023, 219,083,219 (Class A 218,083,219, Class B 1,000,000) and 219,046,219 (Class A 218,046,219, Class B 1,000,000) shares issued and outstanding as of March 31, 2023 and December 31, 2022, respectively | 952,807 | 947,745 | ||||||
| Accumulated deficit | (357,596 | ) | (342,804 | ) | ||||
| Accumulated other comprehensive (loss) income | (1,169 | ) | 181 | |||||
| Total stockholders equity | 594,042 | 605,122 | ||||||
| Total liabilities and stockholders equity | $ | 613,125 | $ | 621,484 |
NUVATION BIO INC. and Subsidiaries
Condensed Statements of Operations and Comprehensive Loss
(In thousands, except per share data)
| For The Three Months Ended March 31, | 2024 | 2023 | ||||||
| Operating expenses: | ||||||||
| Research and development | $ | 12,842 | $ | 18,787 | ||||
| General and administrative | 7,357 | 7,734 | ||||||
| Total operating expenses | 20,199 | 26,521 | ||||||
| Loss from operations | (20,199 | ) | (26,521 | ) | ||||
| Other income (expense): | ||||||||
| Interest income | 7,130 | 4,979 | ||||||
| Investment advisory fees | (265 | ) | (230 | ) | ||||
| Change in fair value of warrant liability | (1,459 | ) | 142 | |||||
| Net gain (loss) on marketable securities | 1 | (96 | ) | |||||
| Total other income (expense), net | 5,407 | 4,795 | ||||||
| Loss before income taxes | (14,792 | ) | (21,726 | ) | ||||
| Provision for income taxes | ||||||||
| Net loss | $ | (14,792 | ) | $ | (21,726 | ) | ||
| Net loss per share attributable to common stockholders, basic and diluted | $ | (0.07 | ) | $ | (0.10 | ) | ||
| Weighted average common shares outstanding, basic and diluted | 219,048 | 218,741 | ||||||
| Comprehensive loss: | ||||||||
| Net loss | $ | (14,792 | ) | $ | (21,726 | ) | ||
| Other comprehensive loss, net of taxes: | ||||||||
| Change in unrealized (loss) gain on available-for-sale securities, net | (1,350 | ) | 2,588 | |||||
| Comprehensive loss | $ | (16,142 | ) | $ | (19,138 | ) |