Full Press Release Details
Nuvation Bio Reports Third Quarter 2024 Financial Results and Provides Business Update
Submitted New Drug Application (NDA) for taletrectinib to the U.S. Food and Drug Administration (FDA) in October for the treatment of
patients with advanced ROS1-positive (ROS1+) non-small cell lung cancer (NSCLC), positioning Company to commercialize taletrectinib, if approved, as early as mid-2025
Presented positive pooled data from the pivotal Phase 2 TRUST-I and TRUST-II studies of taletrectinib in patients with advanced ROS1+ NSCLC at the 2024 European Society of Medical Oncology (ESMO) Congress
Appointed industry veteran Philippe Sauvage as the company s Chief Financial Officer (CFO) in October
Strong balance sheet with cash, cash equivalents, and marketable securities of $549.1 million as of September 30, 2024
New York, November 6, 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 third quarter ended September 30, 2024, and provided a business update.
David Hung, M.D., Founder, President, and Chief Executive Officer of Nuvation Bio, reflected on the quarter and stated: In the third quarter, we
continued to execute on our goal of bringing taletrectinib to people living with ROS1-positive NSCLC as quickly as possible, which has been our focus since we closed the acquisition of AnHeart Therapeutics earlier this year. In October, we completed
the rolling submission of our NDA for line agnostic full approval of taletrectinib in advanced ROS1-positive NSCLC, which was supported by the pooled data from the pivotal Phase 2 TRUST-I and TRUST-II studies that we presented at ESMO. We believe that these data a confirmed objective response rate of 89% and median duration of response approaching four years in the TKI-na ve setting are the strongest data seen to date in the ROS1 space and increase taletrectinib s potential to become a
best-in-class treatment option. Additionally, we are excited about the momentum of our overall pipeline, including safusidenib, our mutant IDH1 inhibitor for both low- and high-grade diffuse IDH1-mutant glioma, where we plan to make meaningful clinical progress next year, and NUV-1511, our first drug-drug conjugate, which we continue to
dose escalate in the clinic.
Recent Pipeline Updates:
Taletrectinib, ROS1 inhibitor: Advanced ROS1+ NSCLC
Safusidenib, mIDH1 inhibitor: Diffuse
NUV-1511, drug-drug conjugate (DDC): Advanced solid tumors
BD2-selective BET inhibitor: Advanced solid tumors
Third Quarter 2024 Financial
As of September 30, 2024, Nuvation Bio had cash, cash equivalents and marketable securities of $549.1 million.
For the three months ended September 30, 2024, research and development expenses were $27.7 million, compared to $18.5 million for the three
months ended September 30, 2023. The increase was primarily due to a $6.7 million increase in personnel-related costs driven by the acquisition of AnHeart, stock-based compensation and other benefits, $2.4 million increase in
third-party costs related to research services and drug manufacturing as a result of clinical trial expense for taletrectinib and $0.1 million increase in amortization of assembled workforce.
For the three months ended September 30, 2024, general and administrative expenses were $19.6 million, compared to $7.8 million for the three
months ended September 30, 2023. The increase was due to a $5.3 million increase in personnel-related costs as a result of the acquisition of AnHeart, $4.2 million increase in sales and marketing expense, $1.8 million increase in
professional fees, $0.7 million increase in legal fees, and $0.4 million increase in occupancy expense offset by $0.4 million increase in foreign currency impact and $0.2 million decrease in insurance expense.
For the three months ended September 30, 2024, Nuvation Bio reported a net loss of $41.2 million, or $(0.15) per share. This compares to a net loss
of $19.6 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 advanced ROS1+ NSCLC. Taletrectinib is being evaluated for the treatment of patients with advanced ROS1+ 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+ NSCLC and other NSCLC indications, and Breakthrough Therapy Designations by both the U.S. FDA and China s National Medical Products Administration (NMPA) for the treatment of
patients with locally advanced or metastatic ROS1+ NSCLC. Based on pooled results of the TRUST-I and TRUST-II clinical studies, Nuvation Bio submitted an NDA for taletrectinib to the U.S. FDA for the treatment of patients with advanced ROS1+ NSCLC
(line agnostic, full approval). 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+ NSCLC who either have or have not previously been treated with ROS1 TKIs.
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
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 FDA
acceptance, the length of the review period, and full approval of a U.S. NDA for taletrectinib, the timing of FDA approval and commercial launch, our expectations of establishing a commercial organization, taletrectinib s best-in-class therapeutic potential in advanced ROS1+ NSCLC, 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 November 6, 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)
| September 30, 2024 | December 31, 2023 | |||||||
| Assets | ||||||||
| Current assets: | ||||||||
| Cash and cash equivalents | $ | 30,036 | $ | 42,649 | ||||
| Accounts receivable, net of allowance for credit loss of $nil | 112 | |||||||
| Prepaid expenses and other current assets | 11,598 | 1,519 | ||||||
| Marketable securities | 519,099 | 568,564 | ||||||
| Interest receivable on marketable securities | 4,140 | 3,702 | ||||||
| Total current assets | 564,985 | 616,434 | ||||||
| Property and equipment, net of accumulated depreciation of $839 and $666, respectively | 719 | 717 | ||||||
| Intangible assets, net of accumulated amortization of $291 | 2,779 | |||||||
| Operating lease right-of-use assets | 2,472 | 3,605 | ||||||
| Lease security deposit | 144 | 141 | ||||||
| Other non-current assets | 480 | 587 | ||||||
| Total assets | $ | 571,579 | $ | 621,484 | ||||
| Liabilities and stockholders equity | ||||||||
| Current liabilities: | ||||||||
| Accounts payable | $ | 12,380 | $ | 2,209 | ||||
| Current operating lease liabilities | 1,781 | 1,972 | ||||||
| Contract liabilities, current portion | 12,942 | |||||||
| Short-term borrowings | 8,426 | |||||||
| Accrued expenses | 23,506 | 9,793 | ||||||
| Total current liabilities | 59,035 | 13,974 | ||||||
| Warrant liability | 908 | 353 | ||||||
| Contract liabilities, net of current portion | 7,937 | |||||||
| Non-current operating lease liabilities | 985 | 2,035 | ||||||
| Total liabilities | 68,865 | 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 September 30, 2024 and December 31, 2023, 336,248,642 (Class A 335,248,642, 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 September 30, 2024 and December 31, 2023, respectively | 1,362,631 | 947,745 | ||||||
| Accumulated deficit | (861,298 | ) | (342,804 | ) | ||||
| Accumulated other comprehensive income | 1,381 | 181 | ||||||
| Total stockholders equity | 502,714 | 605,122 | ||||||
| Total liabilities and stockholders equity | $ | 571,579 | $ | 621,484 |
NUVATION BIO INC. and Subsidiaries
Consolidated Statements of Operations and Comprehensive Loss
(In thousands, except per share data)
| Three Months Ended September 30, | Nine Months Ended September 30, | |||||||||||||||
| 2024 | 2023 | 2024 | 2023 | |||||||||||||
| Revenue | $ | 727 | $ | $ | 2,162 | $ | ||||||||||
| Cost of revenue | 1,515 | 2,862 | ||||||||||||||
| Gross deficit | (788 | ) | (700 | ) | ||||||||||||
| Operating expenses: | ||||||||||||||||
| Research and development | 27,731 | 18,561 | 69,820 | 55,938 | ||||||||||||
| Acquired in-process research and development | 425,070 | |||||||||||||||
| General and administrative | 19,582 | 7,778 | 43,095 | 23,053 | ||||||||||||
| Total operating expenses | 47,313 | 26,339 | 537,985 | 78,991 | ||||||||||||
| Loss from operations | (48,101 | ) | (26,339 | ) | (538,685 | ) | (78,991 | ) | ||||||||
| Other income (expense): | ||||||||||||||||
| Interest income | 6,726 | 6,523 | 21,000 | 17,588 | ||||||||||||
| Interest expense | (120 | ) | (252 | ) | ||||||||||||
| Investment advisory fees | (237 | ) | (228 | ) | (749 | ) | (689 | ) | ||||||||
| Change in fair value of warrant liability | 533 | 383 | 209 | 260 | ||||||||||||
| Realized (loss) gain on marketable securities | (11 | ) | 12 | (17 | ) | (183 | ) | |||||||||
| Total other income (expense), net | 6,891 | 6,690 | 20,191 | 16,976 | ||||||||||||
| Loss before income taxes | (41,210 | ) | (19,649 | ) | (518,494 | ) | (62,015 | ) | ||||||||
| Provision for income taxes | ||||||||||||||||
| Net loss | $ | (41,210 | ) | $ | (19,649 | ) | $ | (518,494 | ) | $ | (62,015 | ) | ||||
| Net loss attributable to common stockholders | ||||||||||||||||
| Net loss per share attributable to common stockholders, basic and diluted | $ | (0.15) | $ | (0.09) | $ | (2.11) | $ | (0.28) | ||||||||
| Weighted average common shares outstanding, basic and diluted | 273,565 | 218,935 | 245,885 | 218,842 | ||||||||||||
| Comprehensive loss: | ||||||||||||||||
| Net loss | $ | (41,210 | ) | $ | (19,649 | ) | $ | (518,494 | ) | $ | (62,015 | ) | ||||
| Other comprehensive loss, net of taxes: | ||||||||||||||||
| Currency translation adjustment | (742 | ) | (594 | ) | ||||||||||||
| Unrealized gain on available-for-sale securities | 3,389 | 1,097 | 1,794 | 2,228 | ||||||||||||
| Comprehensive loss | $ | (38,563 | ) | $ | (18,552 | ) | $ | (517,294 | ) | $ | (59,787 | ) |