Nuvation Bio Reports Third Quarter 2022 Financial Results and Provides Business Update

Nuvation Bio Reports Third Quarter 2022 Financial Results and Provides Business Update

 

  Dosing underway for Phase 1 monotherapy study of NUV-868 in advanced solid tumors  

 

  Expect to initiate Phase 1b combination study of NUV-868 by the end of 2022  

 

  On track to nominate first clinical candidate from Drug-Drug Conjugate (DDC) platform by the end of 2022  

 

  Strong financial position provides cash runway through 2028; cash, cash equivalents and marketable securities of $673.9 million as of September 30, 2022  

 

 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, 2022, and provided a business update.

 

"We are encouraged by the continued clinical progress of NUV-868 and look forward to the initiation of Phase 1b combination cohorts later this year, which we anticipate will provide better understanding of the potential benefit this therapy can offer a wide range of patients with advanced solid tumors," said David Hung, M.D., Founder, President and Chief Executive Officer of Nuvation Bio. "We also expect to nominate the first clinical candidate from our DDC platform by the end of 2022, underscoring the growth-driving capabilities of this platform as we work to tackle some of the greatest unmet needs in oncology."

 

  Recent Business Updates  

 

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

 
  •   Dosing ongoing in the Phase 1 monotherapy study of NUV-868. Nuvation Bio continues to enroll the Phase 1 monotherapy study in advanced solid tumors. The Company expects to initiate the Phase 1b study of NUV-868 in combination with olaparib in ovarian, pancreatic, metastatic castration-resistant prostate and triple negative breast cancers, or in combination with enzalutamide in metastatic castration-resistant prostate cancer, by the end of 2022.
  •  

  Drug-Drug Conjugate Platform:   Solid tumors  

 
  •   Nomination of first clinical candidate from the DDC platform is expected by the end of 2022.
  •  

  Third Quarter 2022 Financial Results  

 

As of September 30, 2022, Nuvation Bio had cash, cash equivalents and marketable securities of $673.9 million.

 

For the three months ended September 30, 2022, research and development expenses were $21.3 million, compared to $17.1 million for the three months ended September 30, 2021. The increase was primarily due to restructuring costs of $1.6 million related to severance and benefit costs and $5.7 million related to contract termination costs offset by $2.8 million decrease in third-party costs related to research services and manufacturing, as well as a $0.3 million decrease in personnel-related costs driven by the termination of the NUV-422 program.

 

For the three months ended September 30, 2022, general and administrative expenses were $8.0 million, compared to $5.7 million for the three months ended September 30, 2021. The increase was primarily due to a $1.9 million increase in personnel-related costs driven by an increase in headcount and stock-based compensation, a $0.2 million increase in occupancy expenses, a $0.1 million increase in professional fees, and a $0.1 million of restructuring costs related to severance and benefit costs.

 

For the three months ended September 30, 2022, Nuvation Bio reported a net loss of $27.2 million, or $(0.12) per share. This compares to a net loss of $22.0 million, or $(0.11) per share, for the comparable period in 2021.

 

  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 expected timing of clinical trial initiation, the expected timing of clinical candidate nomination from the DDC platform, Nuvation Bio's cash runway and the potential therapeutic benefit of its product candidates. 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; risks related to cost reduction efforts; 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 or about November 3, 2022, 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,  
    

  2022  

 
 

  2021  

 
     
  Assets    
Current assets:   
Cash and cash equivalents  

$

 
 

138,690

 
 

 

 
 

$

 
 

132,423

 
 

 

 
Prepaid expenses and other current assets  

 

 
 

5,094

 
 

 

 
 

 

 
 

3,642

 
 

 

 
Marketable securities  

 

 
 

535,255

 
 

 

 
 

 

 
 

632,969

 
 

 

 
Interest receivable on marketable securities  

 

 
 

2,350

 
 

 

 
 

 

 
 

3,039

 
 

 

 
Total current assets  

 

 
 

681,389

 
 

 

 
 

 

 
 

772,073

 
 

 

 
Property and equipment, net  

 

 
 

902

 
 

 

 
 

 

 
 

786

 
 

 

 
Operating lease right-of-use assets  

 

 
 

4,060

 
 

 

 
 

 

 
 

2,871

 
 

 

 
Lease security deposit  

 

 
 

138

 
 

 

 
 

 

 
 

421

 
 

 

 
Total assets  

$

 
 

686,489

 
 

 

 
 

$

 
 

776,151

 
 

 

 
   
  Liabilities and stockholders' equity      
Current liabilities:   
Accounts payable  

$

 
 

2,995

 
 

 

 
 

$

 
 

3,925

 
 

 

 
Current operating lease liabilities  

 

 
 

1,100

 
 

 

 
 

 

 
 

863

 
 

 

 
Accrued expenses  

 

 
 

9,916

 
 

 

 
 

 

 
 

12,137

 
 

 

 
Total current liabilities  

 

 
 

14,011

 
 

 

 
 

 

 
 

16,925

 
 

 

 
Warrant liability  

 

 
 

1,171

 
 

 

 
 

 

 
 

11,037

 
 

 

 
Non-current operating lease liabilities  

 

 
 

3,372

 
 

 

 
 

 

 
 

2,192

 
 

 

 
Total liabilities  

 

 
 

18,554

 
 

 

 
 

 

 
 

30,154

 
 

 

 
     
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, 2022 and December 31, 2021,   
218,392,607 (Class A 217,392,607, Class B 1,000,000) and 217,948,568 (Class A 216,948,568, Class B 1,000,000)   
shares issued and outstanding as of September 30, 2022 and December 31, 2021, respectively  

 

 
 

922,209

 
 

 

 
 

 

 
 

909,985

 
 

 

 
Accumulated deficit  

 

 
 

(246,157

 
 

)

 
 

 

 
 

(162,803

 
 

)

 
Accumulated other comprehensive income  

 

 
 

(8,117

 
 

)

 
 

 

 
 

(1,185

 
 

)

 
Total stockholders' equity  

 

 
 

667,935

 
 

 

 
 

 

 
 

745,997

 
 

 

 
Total liabilities and stockholders' equity  

$

 
 

686,489

 
 

 

 
 

$

 
 

776,151

 
 

 

 
 
                                                                                                                                                                                                                                                                                                                               
  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,  
  

  2022  

 
 

  2021  

 
 

  2022  

 
 

  2021  

 
     
     
  Operating expenses:      
Research and development  

$

 
 

21,294

 
 

 

 
 

$

 
 

17,122

 
 

 

 
 

$

 
 

70,944

 
 

 

 
 

$

 
 

47,035

 
 

 

 
General and administrative  

 

 
 

8,044

 
 

 

 
 

 

 
 

5,669

 
 

 

 
 

 

 
 

24,455

 
 

 

 
 

 

 
 

16,674

 
 

 

 
  Total operating expenses   

 

 
 

29,338

 
 

 

 
 

 

 
 

22,791

 
 

 

 
 

 

 
 

95,399

 
 

 

 
 

 

 
 

63,709

 
 

 

 
     
  Loss from operations   

 

 
 

(29,338

 
 

)

 
 

 

 
 

(22,791

 
 

)

 
 

 

 
 

(95,399

 
 

)

 
 

 

 
 

(63,709

 
 

)

 
     
  Other income (expense):      
Interest income  

 

 
 

2,127

 
 

 

 
 

 

 
 

847

 
 

 

 
 

 

 
 

3,925

 
 

 

 
 

 

 
 

2,061

 
 

 

 
Investment advisory fees  

 

 
 

(263

 
 

)

 
 

 

 
 

(170

 
 

)

 
 

 

 
 

(647

 
 

)

 
 

 

 
 

(454

 
 

)

 
Change in fair value of warrant liability  

 

 
 

462

 
 

 

 
 

 

 
 

125

 
 

 

 
 

 

 
 

9,866

 
 

 

 
 

 

 
 

332

 
 

 

 
Realized (loss) gain on marketable securities  

 

 
 

(191

 
 

)

 
 

 

 
 

10

 
 

 

 
 

 

 
 

(1,099

 
 

)

 
 

 

 
 

56

 
 

 

 
  Total other (expense) income, net   

 

 
 

2,135

 
 

 

 
 

 

 
 

812

 
 

 

 
 

 

 
 

12,045

 
 

 

 
 

 

 
 

1,995

 
 

 

 
     
  Loss before income taxes   

 

 
 

(27,203

 
 

)

 
 

 

 
 

(21,979

 
 

)

 
 

 

 
 

(83,354

 
 

)

 
 

 

 
 

(61,714

 
 

)

 
     
Provision for income taxes  

 

 
 

-

 
 

 

 
 

 

 
 

-

 
 

 

 
 

 

 
 

-

 
 

 

 
 

 

 
 

-

 
 

 

 
     
  Net loss   

$

 
 

(27,203

 
 

)

 
 

$

 
 

(21,979

 
 

)

 
 

$

 
 

(83,354

 
 

)

 
 

$

 
 

(61,714

 
 

)

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

$

 
 

(0.12

 
 

)

 
 

$

 
 

(0.11

 
 

)

 
 

$

 
 

(0.39

 
 

)

 
 

$

 
 

(0.32

 
 

)

 
Weighted average common shares outstanding, basic and diluted  

 

 
 

218,300

 
 

 

 
 

 

 
 

207,101

 
 

 

 
 

 

 
 

216,123

 
 

 

 
 

 

 
 

193,730

 
 

 

 
     
  Comprehensive loss:      
Net loss  

$

 
 

(27,203

 
 

)

 
 

$

 
 

(21,979

 
 

)

 
 

$

 
 

(83,354

 
 

)

 
 

$

 
 

(61,714

 
 

)

 
Other comprehensive income, net of taxes:     
Unrealized loss on available-for-sale securities  

 

 
 

(1,139

 
 

)

 
 

 

 
 

(369

 
 

)

 
 

 

 
 

(6,932

 
 

)

 
 

 

 
 

(1,169

 
 

)

 
     
  Comprehensive loss   

$

 
 

(28,342

 
 

)

 
 

$

 
 

(22,348

 
 

)

 
 

$

 
 

(90,286

 
 

)

 
 

$

 
 

(62,883

 
 

)

 
 

 

 

  

  

  Nuvation Bio Investor Contact:
  ir@nuvationbio.com  

 

  Nuvation Bio Media Contact:
Argot Partners
Leo Vartorella
leo@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 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  

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
Sona Nanotech

Sona Nanotech Grants Options

Sona Nanotech Inc. (CSE: SONA) (OTCQB: SNANF) (the "Company" or "Sona") is pleased to announce that it has granted 25,000 incentive stock options under the Company's Stock Option Plan ("Option Plan") to a consultant. Each option is exercisable into one common share at a price of $0.30 per share and will vest at the rate of 25% every six months. The options will expire five years from the date of grant. All other terms and conditions of the options are in accordance with the terms of the Company's Option Plan.

Contact:
David Regan, CEO
+1-902-536-1932
david@sonanano.com

Keep reading...Show less
Sona Nanotech

Sona Nanotech


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

Latest Press Releases

Related News

×