Nuvation Bio Reports Third Quarter 2023 Financial Results and Provides Business Update

Nuvation Bio Reports Third Quarter 2023 Financial Results and Provides Business Update

Phase 1 monotherapy study of NUV-868 and Phase 1b study of NUV-868 in combination with olaparib or enzalutamide are ongoing

Expect to submit an IND for first Drug-Drug Conjugate (DDC) clinical candidate by year end 2023

Strong balance sheet with cash, cash equivalents, and marketable securities of $619.3 million as of September 30, 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 its financial results for the third quarter ended September 30, 2023, and provided a business update.

"We remain focused on strong clinical execution of our NUV-868 program for advanced solid tumors," said David Hung, M.D., Founder, President, and Chief Executive Officer of Nuvation Bio. "We look forward to expanding our clinical pipeline with an IND submission for our first DDC clinical candidate expected before the end of the year, building upon our unwavering commitment to bringing transformative cancer therapies to patients who need them most."

Recent Business Updates

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

  • Dosing underway in the Phase 1 monotherapy study and both regimens of the Phase 1b combination study. Nuvation Bio continues to treat patients in the Phase 1 monotherapy study of NUV-868 in advanced solid tumors, the Phase 1b study 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 the Phase 1b study of NUV-868 in combination with enzalutamide in patients with mCRPC.

Drug-Drug Conjugate Platform: Solid tumors

  • Nominated first clinical candidate. Nuvation Bio remains on track to submit an Investigational New Drug (IND) application for an undisclosed DDC candidate with the U.S. Food and Drug Administration by year end 2023.

Third Quarter 2023 Financial Results

As of September 30, 2023, Nuvation Bio had cash, cash equivalents and marketable securities of $619.3 million. For the three months ended September 30, 2023, research and development expenses were $18.6 million, compared to $21.3 million for the three months ended September 30, 2022. The decrease was primarily due to a $0.7 million decrease in personnel-related costs driven by a headcount reduction as well as a $2.0 million decrease in third-party costs related to research services and manufacturing primarily due to the termination of the NUV-422 program.

For the three months ended September 30, 2023, general and administrative expenses were $7.8 million, compared to $8.1 million for the three months ended September 30, 2022. The decrease was primarily due to a $0.6 million decrease in insurance and a $0.1 million decrease in recruiting and computer expenses offset by a $0.4 million increase in personnel-related costs driven by stock-based compensation and other benefits.

For the three months ended September 30, 2023, Nuvation Bio reported a net loss of $19.6 million, or $(0.09) per share. This compares to a net loss of $27.2 million, or $(0.12) per share, for the comparable period in 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, the expected continued momentum of Nuvation Bio's clinical trials and the expected timing of an IND filing for Nuvation Bio's first DDC clinical candidate. 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-Q to be filed with the SEC on November 2, 2023, 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
Unaudited
(In thousands, except share and per share data) September 30, December 31,

2023

2022

Assets
Current assets:
Cash and cash equivalents

$

24,395

$

101,099

Prepaid expenses and other current assets

2,976

3,819

Marketable securities

594,944

559,915

Interest receivable on marketable securities

3,033

2,485

Total current assets

625,348

667,318

Property and equipment, net

764

894

Operating lease right-of-use assets

4,033

3,791

Lease security deposit

138

138

Other non-current assets

587

Total assets

$

630,870

$

672,141

Liabilities and stockholders' equity
Current liabilities:
Accounts payable

$

2,373

$

2,139

Current operating lease liabilities

1,915

1,206

Accrued expenses

11,855

9,816

Total current liabilities

16,143

13,161

Warrant liability

590

850

Non-current operating lease liabilities

2,549

3,054

Total liabilities

19,282

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 September 30, 2023 and December 31, 2022,
218,944,053 (Class A 217,944,053, Class B 1,000,000) and 218,632,699 (Class A 217,632,699, Class B 1,000,000)
shares issued and outstanding as of September 30, 2023 and December 31, 2022, respectively

943,903

927,604

Accumulated deficit

(329,017

)

(267,002

)

Accumulated other comprehensive income

(3,298

)

(5,526

)

Total stockholders' equity

611,588

655,076

Total liabilities and stockholders' equity

$

630,870

$

672,141

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,

2023

2022

2023

2022

Operating expenses:
Research and development

$

18,561

$

21,294

$

55,938

$

70,944

General and administrative

7,778

8,044

23,053

24,455

Total operating expenses

26,339

29,338

78,991

95,399

Loss from operations

(26,339

)

(29,338

)

(78,991

)

(95,399

)

Other income (expense):
Interest income

6,523

2,127

17,588

3,925

Investment advisory fees

(228

)

(263

)

(689

)

(647

)

Change in fair value of warrant liability

383

462

260

9,866

Realized gain (loss) on marketable securities

12

(191

)

(183

)

(1,099

)

Total other income (expense), net

6,690

2,135

16,976

12,045

Loss before income taxes

(19,649

)

(27,203

)

(62,015

)

(83,354

)

Provision for income taxes

Net loss

$

(19,649

)

$

(27,203

)

$

(62,015

)

$

(83,354

)

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

$

(0.09

)

$

(0.12

)

$

(0.28

)

$

(0.39

)

Weighted average common shares outstanding, basic and diluted

218,935

218,300

218,842

216,123

Comprehensive loss:
Net loss

$

(19,649

)

$

(27,203

)

$

(62,015

)

$

(83,354

)

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

1,097

(1,139

)

2,228

(6,932

)

Comprehensive loss

$

(18,552

)

$

(28,342

)

$

(59,787

)

$

(90,286

)

Nuvation Bio Investor Contact:
ir@nuvationbio.com

Nuvation Bio Media Contact:
nuvation@argotpartners.com

News Provided by Business Wire via QuoteMedia

NUVB
The Conversation (0)
Nuvation Bio Announces Appointment of Dr. Robert Mashal to its Board of Directors

Nuvation Bio Announces Appointment of Dr. Robert Mashal to its Board of Directors

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 announced the appointment of Robert Mashal, M.D. to its Board of Directors.

"We are delighted to have Dr. Mashal join our Board of Directors," said David Hung, M.D., Founder, President, and Chief Executive Officer of Nuvation Bio. "Robert is a seasoned biotech industry veteran and his experience as an investor, operator, and medical oncologist will provide us with valuable insights. We look forward to working with Robert to advance Nuvation's pipeline."

News Provided by Business Wire via QuoteMedia

Keep reading...Show less
Nuvation Bio Announces FDA Clearance of Investigational New Drug Application for NUV-1511 for the Treatment of Advanced Solid Tumors

Nuvation Bio Announces FDA Clearance of Investigational New Drug Application for NUV-1511 for the Treatment of Advanced Solid Tumors

NUV-1511 is the first clinical candidate from the company's novel drug-drug conjugate platform

Company anticipates initiating a Phase 1/2 clinical study of NUV-1511 in 1H 2024

News Provided by Business Wire via QuoteMedia

Keep reading...Show less
Nuvation Bio Reports Second Quarter 2023 Financial Results and Provides Business Update

Nuvation Bio Reports Second Quarter 2023 Financial Results and Provides Business Update

Enrollment ongoing in the Phase 1b study of NUV-868 in combination with olaparib or enzalutamide

Enrollment ongoing in the Phase 1 monotherapy study of NUV-868

News Provided by Business Wire via QuoteMedia

Keep reading...Show less
Nuvation Bio Announces Formation of Oncology-Focused Scientific Advisory Board

Nuvation Bio Announces Formation of Oncology-Focused Scientific Advisory Board

Scientific Advisory Board members bring significant global expertise in oncology drug and clinical development

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 announced the formation of a Scientific Advisory Board. The Scientific Advisory Board will work alongside the Nuvation Bio management team to advance its pipeline of therapeutic candidates for some of the most difficult-to-treat cancers.

News Provided by Business Wire via QuoteMedia

Keep reading...Show less
Nuvation Bio Reports First Quarter 2023 Financial Results and Provides Business Update

Nuvation Bio Reports First Quarter 2023 Financial Results and Provides Business Update

Enrollment ongoing in the Phase 1b study of NUV-868 in combination with olaparib or enzalutamide

Enrollment ongoing in the Phase 1 monotherapy study of NUV-868

News Provided by Business Wire via QuoteMedia

Keep reading...Show less
Longeveron to Present at the Emerging Growth Virtual Conference on June 12, 2024

Longeveron to Present at the Emerging Growth Virtual Conference on June 12, 2024

Longeveron Inc. (NASDAQ: LGVN), a clinical stage biotechnology company developing regenerative medicines, today announced that it will participate in the Emerging Growth Virtual Conference taking place June 12-13, 2024.

Details for the Company's presentation:

News Provided by GlobeNewswire via QuoteMedia

Keep reading...Show less
Veru to Present at the American Diabetes Association's 84th Scientific Sessions

Veru to Present at the American Diabetes Association's 84th Scientific Sessions

Veru Inc. (NASDAQ: VERU), a late clinical stage biopharmaceutical company focused on developing innovative medicines for preserving muscle for high quality weight loss, oncology, and viral induced acute respiratory distress syndrome, today announced that the Company will present two presentations at the American Diabetes Association's 84 th Scientific Sessions, taking place June 21-24, 2024, in Orlando, Florida.

The presentations are:

News Provided by GlobeNewswire via QuoteMedia

Keep reading...Show less
Dr. Giovanni Selvaggi, Who Has Brought Several Oncology Drugs to Market, Joins CEL-SCI as Clinical Advisor

Dr. Giovanni Selvaggi, Who Has Brought Several Oncology Drugs to Market, Joins CEL-SCI as Clinical Advisor

  • Dr. Selvaggi was instrumental in the development and approval of lung cancer drugs Zykadia for Novartis and Opdivo for Bristol Myers Squibb
  • CEL-SCI's Multikine immunotherapy improves the 5-year survival of head and neck cancer patients to 73% compared to 45% in controls and cuts the 5-year risk of death by 50%
  • FDA has given CEL-SCI the go-ahead to commence a confirmatory Registration Study for Multikine for the target population in head and neck cancer
  • Dr. Selvaggi will be supporting CEL-SCI to bring Multikine to patients through a confirmatory registrational path that has been agreed with regulatory authorities and that has a potential for cure

CEL-SCI Corporation (NYSE American: CVM) today announced Dr. Giovanni Selvaggi, an oncology key opinion leader instrumental in successfully bringing several drugs to market has joined CEL-SCI as a Clinical Advisor. Dr. Selvaggi joins CEL-SCI as the Company recently received its go-ahead from the U.S. Food and Drug Administration (FDA) for its confirmatory Registration Study of Multikine* in the treatment of head and neck cancer.

This press release features multimedia. View the full release here: https://www.businesswire.com/news/home/20240606671425/en/

News Provided by Business Wire via QuoteMedia

Keep reading...Show less

Ventyx Biosciences Announces Positive Preclinical Data for CNS-Penetrant NLRP3 Inhibitor VTX3232 Demonstrating Reversal of Obesity and Improvements in Cardiometabolic and Inflammatory Markers

VTX3232 demonstrated improvements in body weight, systemic inflammatory biomarkers and cardiometabolic parameters in diet-induced obesity (DIO) mice

Additive effects were observed for VTX3232 in combination with the GLP-1 receptor agonist semaglutide across key endpoints compared to semaglutide or VTX3232 alone

News Provided by GlobeNewswire via QuoteMedia

Keep reading...Show less
Longeveron® Announces Contract Development and Manufacturing Business and First Contract

Longeveron® Announces Contract Development and Manufacturing Business and First Contract

  • Contract manufacturing services as a new business line has the potential to generate approximately $4-5 million in annual revenues
  • First manufacturing services contract signed with Secretome Therapeutics

Longeveron Inc. (NASDAQ: LGVN), a clinical stage regenerative medicine biotechnology company developing cellular therapies for life-threatening and chronic aging-related conditions, today announced the launch of its contract development and manufacturing business at the Company's 15,000 square feet state-of-the-art Good Manufacturing Practice (GMP) facility. This facility contains 3,000 square feet of cleanroom space, including eight ISO 7 cleanrooms and ancillary areas, as well as 1,150 square feet of process development, quality control and warehousing space. The Company also announced the initiation of work under its first manufacturing services contract with Secretome Therapeutics a biotechnology company developing first-in-class therapeutics from neonatal mesenchymal stem cells (nMSC).

News Provided by GlobeNewswire via QuoteMedia

Keep reading...Show less
Caribou Biosciences Presents Encouraging Clinical Data from CB-010 ANTLER Phase 1 Trial in Second-line LBCL Patients at the 2024 American Society of Clinical Oncology  Annual Meeting

Caribou Biosciences Presents Encouraging Clinical Data from CB-010 ANTLER Phase 1 Trial in Second-line LBCL Patients at the 2024 American Society of Clinical Oncology Annual Meeting

-- CB-010 allogeneic CAR-T cell therapy w ith partial HLA matching has potential to rival efficacy and safety profile of approved autologous CAR-T cell therapies --

-

News Provided by GlobeNewswire via QuoteMedia

Keep reading...Show less

Latest Press Releases

Related News

×