8-K
Nuvation Bio Inc. (NUVB)
UNITED STATES
SECURITIES AND EXCHANGE COMMISSION
Washington, D.C. 20549
FORM 8-K
CURRENT REPORT
Pursuant to Section 13 or 15(d)
of the Securities Exchange Act of 1934
Date of Report (Date of earliest event reported): May 14, 2024
Nuvation Bio Inc.
(Exact name of registrant as specified in its charter)
| Delaware | 001-39351 | 85-0862255 |
|---|---|---|
| (State or other jurisdiction<br> <br>of incorporation) | (Commission<br> <br>File Number) | (I.R.S. Employer<br> <br>Identification No.) |
| 1500 Broadway, Suite 1401<br> <br>New York, NY 10036 | ||
| --- | ||
| (Address of principal executive offices) |
(332) 208-6102
(Registrant’s telephone number, including area code)
Check the appropriate box below if the Form 8-K filing is intended to simultaneously satisfy the filing obligation of the registrant under any of the following provisions:
| ☐ | Written communications pursuant to Rule 425 under the Securities Act (17 CFR 230.425) |
|---|---|
| ☐ | Soliciting material pursuant to Rule 14a-12 under the Exchange Act (17 CFR 240.14a-12) |
| --- | --- |
| ☐ | Pre-commencement communications pursuant to Rule 14d-2(b) under the Exchange Act (17 CFR 240.14d-2(b)) |
| --- | --- |
| ☐ | Pre-commencement communications pursuant to Rule 13e-4(c) under Exchange Act (17 CFR 240.13e-4(c)) |
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Securities registered pursuant to Section 12(b) of the Act:
| Title of each class | Trading<br> <br>Symbol(s) | Name of each exchange<br> <br>on which registered |
|---|---|---|
| Class A Common Stock, $0.0001 par value per share | NUVB | The New York Stock Exchange |
| Redeemable Warrants, each whole warrant exercisable for one share of Common Stock at an exercise price of $11.50 per share | NUVB.WS | The New York Stock Exchange |
Indicate by check mark whether the registrant is an emerging growth company as defined in Rule 405 of the Securities Act of 1933(§230.405 of this chapter) or Rule 12b-2 of the Securities Exchange Act of 1934 (§240.12b-2 of this chapter).
Emerging growth company ☐
If an emerging growth company, indicate by check mark if the registrant has elected not to use the extended transition period for complying with any new or revised financial accounting standards provided pursuant to Section 13(a) of the Exchange Act. ☐
| ITEM 2.02. | RESULTS OF OPERATIONS AND FINANCIAL CONDITION |
|---|
On May 14, 2024, Nuvation Bio Inc. issued a press release announcing its financial results for the quarter ended March 31, 2024. A copy of the press release is furnished as Exhibit 99.1 to this Form 8-K.
The information contained in this Form 8-K, including in the accompanying Exhibit 99.1, shall not be deemed filed for purposes of Section 18 of the Securities Exchange Act of 1934, as amended, or incorporated by reference in any filing under the Exchange Act or the Securities Act of 1933, as amended, except as shall be expressly set forth by specific reference in such filing.
| ITEM 9.01 | FINANCIAL STATEMENTS AND EXHIBITS |
|---|---|
| (d) | Exhibits. |
| --- | --- |
| Exhibit<br> <br>Number | Description |
| --- | --- |
| 99.1 | Press Release of Nuvation Bio Inc. dated May 14, 2024. |
| 104 | Cover Page Interactive Data File (embedded within XBRL document) |
2
SIGNATURES
Pursuant to the requirements of the Securities Exchange Act of 1934, as amended, the registrant has duly caused this report to be signed on its behalf by the undersigned hereunto duly authorized.
| Dated: May 14, 2024 | NUVATION BIO INC. | |
|---|---|---|
| By: | /s/ Moses Makunje | |
| Name: | Moses Makunje | |
| Title: | VP, Finance, Principal Financial and Accounting Officer |
3
EX-99.1
Exhibit 99.1
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 acommercial organization by the end of 2025
Updated data from the pivotal Phase 2 TRUST-Iclinical 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, andmarketable 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 development.”
Recent Pipeline Updates:
Taletrectinib, ROS1 inhibitor: Advanced 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 in China, and TRUST-II, a global study. |
|---|---|
| • | Updated data from the Phase 2 TRUST-I clinical study (NCT04395677)<br>evaluating taletrectinib in patients in China with advanced ROS1-positive NSCLC will be reported in an oral presentation (abstract #8520) at the 2024 ASCO Annual Meeting on Saturday, June 1, 2024, at<br>4:30-6:30 p.m. CT/5:30-7:30 p.m. ET. |
| --- | --- |
Safusidenib,mIDH1 inhibitor: Grades 2 and 3 IDH1-mutant glioma
| • | Safusidenib is being evaluated in a global Phase 2 study for the treatment of patients with grades 2 and 3<br>IDH1-mutant glioma. |
|---|
NUV-868, BD2-selectiveBET inhibitor: Advanced solid tumors
| • | NUV-868 is being evaluated in a Phase 1b dose escalation study in<br>combination with olaparib for the treatment of patients with ovarian cancer, pancreatic cancer, metastatic castration-resistant prostate cancer (mCRPC), triple negative breast cancer, and other solid tumors, and in combination with enzalutamide for<br>the treatment of patients with mCRPC. |
|---|
NUV-1511, DDC: Advanced solid tumors
| • | NUV-1511, the Company’s first clinical-stage DDC, is being evaluated<br>in a Phase 1/2 study for the treatment of patients with advanced solid tumors who previously received and progressed on or after treatment with Enhertu^®^ and/or Trodelvy^®^ per approved U.S. Food and Drug Administration (FDA) labeling, human epidermal growth factor receptor 2-negative (HER2-) metastatic breast cancer, mCRPC,<br>advanced pancreatic cancer, and platinum-resistant ovarian cancer (PROC). |
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Corporate Updates:
| • | Announced entry into a definitive agreement to acquire AnHeart Therapeutics in March 2024 and completed the<br>acquisition in April 2024. |
|---|---|
| • | Appointed Colleen Sjogren as Chief Commercial Officer. Ms. Sjogren will lead Nuvation Bio’s commercial<br>strategy and operations, including marketing, sales, and market access. |
| --- | --- |
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.
About Nuvation Bio
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 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, 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:
ir@nuvationbio.com
Nuvation Bio Media Contact:
nuvation@argotpartners.com
NUVATION BIO INC. and Subsidiaries
Condensed Balance Sheets
Unaudited
| (In thousands, except share and per share data) | 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<br>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<br>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,<br>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 |
All values are in US Dollars.
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 | ) |