Full Press Release Details
Nuvation Bio Reports Second Quarter 2024 Financial Results and Provides Business Update
Efficacy and safety data from the pivotal Phase 2 TRUST-I clinical study of taletrectinib, a ROS1
inhibitor, published in the Journal of Clinical Oncology and presented at the 2024 American Society of Clinical Oncology (ASCO) Annual Meeting
Company to present pooled data from the pivotal Phase 2 TRUST-I and
TRUST-II studies at the European Society of Medical Oncology (ESMO) Congress 2024, which will support Nuvation Bio s planned New Drug Application (NDA) in the United States
Company to present data from the global, pivotal Phase 2 TRUST-II study at the 2024 World Conference
on Lung Cancer (WCLC)
Taletrectinib Granted Orphan Drug Designation by the U.S. Food and Drug Administration (FDA) for the
treatment of ROS1-positive non-small cell lung cancer (NSCLC) and other NSCLC indications
Strong balance sheet with cash, cash equivalents, and marketable securities of $577.2 million as of June 30, 2024
New York, August 5, 2024 Nuvation Bio Inc. (NYSE: NUVB), a late clinical-stage, global biopharmaceutical company tackling
some of the greatest unmet needs in oncology, today reported financial results for the second quarter ended June 30, 2024, and provided a business update.
In the second quarter, we were pleased to share data at ASCO from TRUST-I, the pivotal study of taletrectinib in
China, which although immature due to an early data cutoff, demonstrated taletrectinib s efficacy, durability, and safety profiles. At WCLC, we will be presenting data from TRUST-II, the global, pivotal
Phase 2 study of taletrectinib, while at ESMO we will present more mature and comprehensive taletrectinib data, including pooled efficacy and safety data from both pivotal TRUST-I and TRUST-II studies. The ESMO data set will be used to support our planned NDA filing in the U.S. and, assuming regulatory approval, will position us to commercialize taletrectinib in 2025, said David Hung, M.D.,
Founder, President, and Chief Executive Officer of Nuvation Bio. We are also progressing the global Phase 2 study of safusidenib and continuing to dose escalate in a Phase 1/2 study of our first clinical-stage drug-drug conjugate, NUV-1511. As we focus on our late-stage pipeline and prepare to potentially bring taletrectinib to patients in the U.S. in 2025, we have decided not to initiate a Phase 2 study of
NUV-868 in the solid tumor indications studied to date. This decision comes after careful review of the data generated in the Phase 1 monotherapy study and Phase 1b study of
NUV-868 in combination with olaparib or enzalutamide. We are exploring next steps for NUV-868 in new indications and will share updates as available. We are proud of
Nuvation Bio s transformational momentum in the first half of this year and look forward to building upon it as we tackle some of the greatest unmet needs in oncology.
Recent Pipeline Updates:
Taletrectinib, ROS1 inhibitor: Advanced ROS1-positive NSCLC
Safusidenib, mIDH1 inhibitor: Diffuse IDH1-mutant glioma
NUV-1511, drug-drug conjugate (DDC): Advanced solid tumors
BD2-selective BET inhibitor: Advanced solid tumors
Second Quarter 2024 Financial Results
June 30, 2024, Nuvation Bio had cash, cash equivalents and marketable securities of $577.2 million.
For the three months ended June 30,
2024, research and development expenses were $29.2 million, compared to $18.6 million for the three months ended June 30, 2023. The increase was primarily due to a $5.9 million increase in personnel-related costs driven by the
acquisition of AnHeart Therapeutics, Ltd. (AnHeart), stock-based compensation and other benefits and a $4.7 million increase in third-party costs related to research services and drug manufacturing as a result of clinical study expense for
On April 9, 2024, as a result of the acquisition of AnHeart, Nuvation Bio recorded a $425.1 million charge representing an
acquired in-process research and development asset with no alternative future use in acquired in-process research and development expenses.
For the three months ended June 30, 2024, general and administrative expenses were $16.1 million,
compared to $7.5 million for the three months ended June 30, 2023. The increase was due to a $3.9 million increase in personnel-related costs as a result of the acquisition of AnHeart, a $1.1 million increase in professional
fees, a $1.2 million increase in marketing expense, a $0.8 million increase in legal fees, a $0.2 million increase in occupancy expense, a $0.2 million increase in foreign currency impact, and a $1.4 million increase in
miscellaneous expense offset by a $0.2 million decrease in insurance expense.
For the three months ended June 30, 2024, Nuvation Bio reported a
net loss of $462.5 million, or $(1.89) per share. This compares to a net loss of $20.6 million, or $(0.09) per share, for the comparable period in 2023.
Taletrectinib is an oral, potent,
central nervous system-active, selective, next-generation ROS1 inhibitor specifically designed for the treatment of patients with ROS1-positive non-small cell lung cancer (NSCLC). Taletrectinib is being
evaluated for the treatment of patients with advanced ROS1-positive NSCLC in two Phase 2 single-arm pivotal studies: TRUST-I (NCT04395677) in China, and TRUST-II (NCT04919811), a global study. Taletrectinib has been granted Orphan Drug Designation by the U.S. FDA for the treatment of patients with ROS1-positive NSCLC and Breakthrough Therapy Designations by both the
U.S. FDA and China s National Medical Products Administration (NMPA) for the treatment of patients with advanced or metastatic ROS1-positive NSCLC. Based on results of the TRUST-I clinical study,
China s NMPA has accepted and granted Priority Review Designations to New Drug Applications for taletrectinib for the treatment of adult patients with locally advanced or metastatic ROS1-positive NSCLC who either have or have not previously
been treated with ROS1 tyrosine kinase inhibitors.
Nuvation Bio is a late clinical-stage, global biopharmaceutical company tackling some of the greatest unmet needs in oncology by developing differentiated and
novel product candidates. Nuvation Bio s portfolio of development candidates includes taletrectinib (ROS1), safusidenib (mIDH1), NUV-1511 (DDC), and NUV-868 (BET).
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 https://www.linkedin.com/company/nuvationbio/.
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, our expectations regarding a U.S. NDA, the expected timing of becoming a commercial organization, the potential therapeutic benefit of Nuvation Bio s product candidates, the
advancement of our 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 August 5, 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
Consolidated Balance Sheets
(In thousands, except share and per share data)
| June 30, | December 31, | |||||||
| 2024 | 2023 | |||||||
| Assets | ||||||||
| Current assets: | ||||||||
| Cash and cash equivalents | $ | 34,285 | $ | 42,649 | ||||
| Accounts receivable, net of allowance for credit loss of $nil | 117 | |||||||
| Prepaid expenses and other current assets | 5,991 | 1,519 | ||||||
| Marketable securities | 542,884 | 568,564 | ||||||
| Interest receivable on marketable securities | 3,895 | 3,702 | ||||||
| Total current assets | 587,172 | 616,434 | ||||||
| Property and equipment, net of accumulated depreciation of $782 and $666, respectively | 751 | 717 | ||||||
| Intangible assets, net of amortization of $138 | 2,932 | |||||||
| Operating lease right-of-use assets | 2,723 | 3,605 | ||||||
| Lease security deposit | 143 | 141 | ||||||
| Other non-current assets | 1,075 | 587 | ||||||
| Total assets | $ | 594,796 | $ | 621,484 | ||||
| Liabilities, mezzanine equity and stockholders equity | ||||||||
| Current liabilities: | ||||||||
| Accounts payable | $ | 5,211 | $ | 2,209 | ||||
| Current operating lease liabilities | 2,076 | 1,972 | ||||||
| Contract liabilities, current portion | 12,200 | |||||||
| Short-term borrowings | 11,634 | |||||||
| Accrued expenses | 19,974 | 9,793 | ||||||
| Total current liabilities | 51,095 | 13,974 | ||||||
| Warrant liability | 1,441 | 353 | ||||||
| Contract liabilities, net of current portion | 9,157 | |||||||
| Non-current operating lease liabilities | 972 | 2,035 | ||||||
| Total liabilities | 62,665 | 16,362 | ||||||
| Mezzanine equity; | ||||||||
| Class A convertible preferred stock, $.0001 par value per share; 851,202 shares outstanding as of June 30, 2024. | 274,938 | |||||||
| Total mezzanine equity | 274,938 | |||||||
| 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 June 30, 2024 and December 31, 2023, 248,624,729 (Class A 247,624,729, 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 June 30, 2024 and December 31, 2023, respectively | 1,078,547 | 947,745 | ||||||
| Accumulated deficit | (820,088 | ) | (342,804 | ) | ||||
| Accumulated other comprehensive income | (1,266 | ) | 181 | |||||
| Total stockholders equity | 257,193 | 605,122 | ||||||
| Total liabilities, mezzanine equity and stockholders equity | $ | 594,796 | $ | 621,484 |
NUVATION BIO INC. and Subsidiaries
Consolidated Statements of Operations and Comprehensive Loss
(In thousands, except per share data)
| Three Months Ended June 30, | Six Months Ended June 30, | |||||||||||||||
| 2024 | 2023 | 2024 | 2023 | |||||||||||||
| Revenue | $ | 1,435 | $ | $ | 1,435 | $ | ||||||||||
| Cost of revenue | 1,347 | 1,347 | ||||||||||||||
| Gross profit | 88 | 88 | ||||||||||||||
| Operating expenses: | ||||||||||||||||
| Research and development | 29,247 | 18,590 | 42,089 | 37,377 | ||||||||||||
| Acquired in-process research and development | 425,070 | 425,070 | ||||||||||||||
| General and administrative | 16,156 | 7,541 | 23,513 | 15,275 | ||||||||||||
| Total operating expenses | 470,473 | 26,131 | 490,672 | 52,652 | ||||||||||||
| Loss from operations | (470,385 | ) | (26,131 | ) | (490,584 | ) | (52,652 | ) | ||||||||
| Other income (expense): | ||||||||||||||||
| Interest income | 7,144 | 6,086 | 14,274 | 11,065 | ||||||||||||
| Interest expense | (132 | ) | (132 | ) | ||||||||||||
| Investment advisory fees | (247 | ) | (231 | ) | (512 | ) | (461 | ) | ||||||||
| Change in fair value of warrant liability | 1,135 | (265 | ) | (324 | ) | (123 | ) | |||||||||
| Realized loss on marketable securities | (7 | ) | (99 | ) | (6 | ) | (195 | ) | ||||||||
| Total other income (expense), net | 7,893 | 5,491 | 13,300 | 10,286 | ||||||||||||
| Loss before income taxes | (462,492 | ) | (20,640 | ) | (477,284 | ) | (42,366 | ) | ||||||||
| Provision for income taxes | ||||||||||||||||
| Net loss | $ | (462,492 | ) | $ | (20,640 | ) | $ | (477,284 | ) | $ | (42,366 | ) | ||||
| Net loss attributable to common stockholders | ||||||||||||||||
| Net loss per share attributable to common stockholders, basic and diluted | $ | (1.89 | ) | $ | (0.09 | ) | $ | (2.06 | ) | $ | (0.19 | ) | ||||
| Weighted average common shares outstanding, basic and diluted | 244,738 | 218,848 | 231,893 | 218,795 | ||||||||||||
| Comprehensive loss: | ||||||||||||||||
| Net loss | $ | (462,492 | ) | $ | (20,640 | ) | $ | (477,284 | ) | $ | (42,366 | ) | ||||
| Other comprehensive loss, net of taxes: | ||||||||||||||||
| Currency translation adjustment | 148 | 148 | ||||||||||||||
| Unrealized (loss) gain on available-for-sale securities | (245 | ) | (1,457 | ) | (1,595 | ) | 1,131 | |||||||||
| Comprehensive loss | $ | (462,589 | ) | $ | (22,097 | ) | $ | (478,731 | ) | $ | (41,235 | ) |