NUVB Panacea Acquisition Corp

Determined maximum tolerated dose (MTD) in Phase 1 monotherapy study of NUV-868; Phase 1b studies of NUV-868 in combination with olaparib or enzalutamide remain ongoing

Received U.S. Food and Drug Administration (FDA) clearance of Investigational New Drug (IND) application for NUV-1511, the first clinical candidate from our novel drug-drug conjugate (DDC) platform

Strong balance sheet with cash, cash equivalents and marketable securities of $611.2 million as of December 31, 2023

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 fourth quarter and full year ended December 31, 2023, and provided a business update.

“We are pleased to announce completion of a Phase 1 monotherapy study of NUV-868 and determination of a MTD that will help inform our ongoing Phase 1b combination studies. As we announced in January, we received FDA clearance of our IND application for NUV-1511 and look forward to initiating a Phase 1/2 study for the first clinical candidate from our DDC platform in the first half of this year,” said David Hung, M.D., Founder, President, and Chief Executive Officer of Nuvation Bio. “Nuvation strongly executed across our pipeline of cancer therapies in 2023 and we plan to build on this progress in 2024 as we remain committed to bringing novel and differentiated therapies to patients with the most difficult-to-treat cancers.”

Recent Business Updates

NUV-868, BD2-selective BETi: Advanced solid tumors

• Phase 1 monotherapy study is complete. Nuvation Bio has completed the Phase 1 monotherapy study in advanced solid tumors and determined the MTD in patients.
• Phase 1b combination studies remain ongoing. Nuvation Bio continues to conduct the Phase 1b studies of NUV-868 in combination with olaparib in 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 in patients with mCRPC.

NUV-1511, Drug-Drug Conjugate Platform: Advanced solid tumors

• IND cleared for first clinical candidate, NUV-1511. Nuvation Bio received IND clearance from the FDA for the treatment of patients with various advanced solid tumors and remains on track to dose the first patient in a Phase 1/2 study of NUV-1511 in the first half of 2024.

Corporate Update:

• Appointed Dr. Robert Mashal to Board of Directors. Dr. Mashal’s experience as a seasoned pharmaceutical executive and medical oncologist will provide valuable insights.

Fourth Quarter and Full Year 2023 Financial Results

As of December 31, 2023, Nuvation Bio had cash, cash equivalents and marketable securities of $611.2 million.

For the three months ended December 31, 2023, research and development expenses were $15.4 million, compared to $16.9 million for the three months ended December 31, 2022. The decrease was primarily due to a $1.7 million decrease in third-party costs related to research services and manufacturing driven by the termination of the NUV-422 program offset by a $0.2 million increase in personnel-related costs. Research and development expenses for the year ended December 31, 2023 were $71.3 million compared to $87.8 million for the year ended December 31, 2022.

For the three months ended December 31, 2023, general and administrative expenses were $5.5 million, compared to $7.4 million for the three months ended December 31, 2022. The decrease was primarily due to a $1.3 million decrease in personnel-related costs, $0.6 million decrease in insurance, a $0.2 million decrease in professional fees, a $0.1 million decrease in taxes and a $0.1 million decrease in miscellaneous expenses offset by $0.2 million increase in legal fees, and a $0.2 million increase in occupancy. General and administrative expenses for the year ended December 31, 2023 were $28.5 million compared to $31.9 million for the year ended December 31, 2022.

For the three months ended December 31, 2023, Nuvation Bio reported a net loss of $13.8 million, or $(0.06) per share. This compares to a net loss of $20.8 million, or $(0.10) per share, for the comparable period in 2022. Net loss for the year ended December 31, 2023 was $75.8 million compared to $104.2 million for the year ended December 31, 2022.

About Nuvation Bio

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 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 initiation of a Phase 1/2 study for NUV-1511 in the first half of 2024. 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 trials 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-K to be filed with the SEC on February 29, 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 INC. and Subsidiaries    

Consolidated Balance Sheets (In thousands, except share and per share data)

December 31,

2023

 

2022

    Assets   Current assets:   Cash and cash equivalents

$

42,649

 

 

$

101,099

 

Prepaid expenses

 

1,519

 

 

 

3,819

 

Marketable securities available-for-sale, at fair value

 

568,564

 

 

 

559,915

 

Interest receivable on marketable securities

 

3,702

 

 

 

2,485

 

Total current assets

 

616,434

 

 

 

667,318

 

Property and equipment, net

 

717

 

 

 

894

 

Lease security deposit

 

141

 

 

 

138

 

Operating lease right-of-use assets

 

3,605

 

 

 

3,791

 

Other non-current assets

 

587

 

 

 

—

 

Total assets

$

621,484

 

 

$

672,141

 

    Liabilities and stockholders' equity   Current liabilities:   Accounts payable

$

2,209

 

 

$

2,139

 

Current operating lease liabilities

 

1,972

 

 

 

1,206

 

Accrued expenses

 

9,793

 

 

 

9,816

 

Total current liabilities

 

13,974

 

 

 

13,161

 

Warrant liability

 

353

 

 

 

850

 

Non-current operating lease liabilities

 

2,035

 

 

 

3,054

 

Total liabilities

 

16,362

 

 

 

17,065

 

    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 December 31, 2023   and December 31, 2022, respectively; 219,046,219 (Class A 218,046,219, Class B 1,000,000) and   218,632,699 (Class A 217,632,699, Class B 1,000,000) issued and outstanding as of December 31, 2023   and 2022, respectively

 

947,745

 

 

 

927,604

 

Accumulated deficit

 

(342,804

)

 

 

(267,002

)

Accumulated other comprehensive income (loss)

 

181

 

 

 

(5,526

)

Total stockholders' equity

 

605,122

 

 

 

655,076

 

Total liabilities and stockholders' equity

$

621,484

 

 

$

672,141

 

NUVATION BIO INC. and Subsidiaries  

Consolidated Statements of Operations and Comprehensive Loss (In thousands, except per share data)

  Three Months Ended December 31, Years Ended December 31,

2023

2022

2023

2022

Operating expenses: Research and development

$

15,351

 

$

16,871

 

$

71,289

 

$

87,815

 

General and administrative

 

5,480

 

 

7,464

 

 

28,533

 

 

31,919

 

Total operating expenses

 

20,831

 

 

24,335

 

 

99,822

 

 

119,734

 

  Loss from operations

 

(20,831

)

 

(24,335

)

 

(99,822

)

 

(119,734

)

Other income (expense): Interest income

 

7,023

 

 

3,523

 

 

24,611

 

 

7,448

 

Investment advisory fees

 

(260

)

 

(225

)

 

(949

)

 

(872

)

Change in fair value of warrant liability

 

237

 

 

321

 

 

497

 

 

10,187

 

Realized gain (loss) on marketable securities

 

44

 

 

(129

)

 

(139

)

 

(1,228

)

Total other income (expense), net

 

7,044

 

 

3,490

 

 

24,020

 

 

15,535

 

  Loss before income taxes

 

(13,787

)

 

(20,845

)

 

(75,802

)

 

(104,199

)

Provision for income taxes

 

—

 

 

—

 

 

—

 

 

—

 

Net loss

$

(13,787

)

$

(20,845

)

$

(75,802

)

$

(104,199

)

  Net loss per share attributable to common stockholders, basic and diluted

$

(0.06

)

$

(0.10

)

$

(0.35

)

$

(0.48

)

Weighted average common shares outstanding, basic and diluted

 

218,993

 

 

218,497

 

 

218,880

 

 

216,721

 

  Comprehensive loss: Net loss

$

(13,787

)

$

(20,845

)

$

(75,802

)

$

(104,199

)

Other comprehensive loss, net of taxes: Change in unrealized gain (loss) on available-for-sale securities, net

 

3,479

 

 

2,591

 

 

5,707

 

 

(4,341

)

Comprehensive loss

$

(10,308

)

$

(18,254

)

$

(70,095

)

$

(108,540

)

 

View source version on businesswire.com: https://www.businesswire.com/news/home/20240229647917/en/

Nuvation Bio Investor Contact: ir@nuvationbio.com

Nuvation Bio Media Contact: nuvation@argotpartners.com