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

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

Strong financial position provides cash runway through 2028; cash, cash equivalents and marketable securities of $703.8 million as of June 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 second quarter ended June 30, 2022, and provided a business update.

“We are committed to advancing innovative therapies as quickly and safely as possible for people with cancers that do not currently have adequate treatment options. As previously announced, this commitment has led us to re-prioritize our pipeline and focus on our BET inhibitor, NUV-868, which is progressing in an ongoing Phase 1 study, and our novel small molecule DDC platform,” said David Hung, M.D., Founder, President and Chief Executive Officer of Nuvation Bio. “With $703.8 million in cash, cash equivalents and marketable securities as of June 30, 2022, and our experienced team — including our new Chief Medical Officer, David Liu, M.D., Ph.D., and our new Chief Regulatory Officer, Kerry Wentworth — we are well positioned to advance our programs for the benefit of patients and our stakeholders.”

Recent Business Updates

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

  • Dosing underway in the Phase 1 monotherapy study of NUV-868. The recently initiated Phase 1 study in advanced solid tumors, including ovarian, pancreatic, metastatic castration-resistant prostate and triple negative breast cancers, is designed to determine the safety and dose of NUV-868 to be used as a monotherapy and in combination with olaparib or enzalutamide for the Phase 2 and Phase 2b portions of the study.

Corporate Updates

  • Strengthened executive management team. The Company appointed David Liu, M.D., Ph.D., as Chief Medical Officer in July 2022, and Kerry Wentworth as Chief Regulatory Officer in May 2022. Both leaders are also part of the Executive Committee.

Second Quarter 2022 Financial Results

As of June 30, 2022, Nuvation Bio had cash, cash equivalents and marketable securities of $703.8 million.

For the three months ended June 30, 2022, research and development expenses were $28.9 million, compared to $14.0 million for the three months ended June 30, 2021. The increase was primarily due to a $12.3 million increase in third-party costs related to research services and manufacturing to advance our current preclinical programs and Phase 1/2 clinical trial, as well as a $2.5 million increase in personnel-related costs driven by an increase in headcount and stock-based compensation.

For the three months ended June 30, 2022, general and administrative expenses were $8.9 million, compared to $6.4 million for the three months ended June 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 $0.4 million increase in other miscellaneous expenses, a $0.1 million increase in legal fees, a $0.1 million increase in taxes, a $0.1 million increase in occupancy expenses, and a $0.1 million increase in insurance, offset by a $0.2 million decrease in professional fees.

For the three months ended June 30, 2022, Nuvation Bio reported a net loss of $34.9 million, or $0.16 per share. This compares to a net loss of $19.3 million, or $0.09 per share, for the comparable period in 2021.

On August 1, 2022, Nuvation Bio announced a restructuring, including a 35% workforce reduction, to reduce operating costs and align its organization with its re-prioritized development programs.

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 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 August 4, 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) June 30,   December 31,
 

2022

 

2021

       
Assets      
Current assets:      
 Cash and cash equivalents 

 $

          102,321

 

 

 $

          132,423

 

 Prepaid expenses and other current assets 

 

                 7,799

 

 

 

                 3,642

 

 Marketable securities  

 

             601,476

 

 

 

             632,969

 

 Interest receivable on marketable securities 

 

                 2,668

 

 

 

                 3,039

 

 Total current assets 

 

             714,264

 

 

 

             772,073

 

Property and equipment, net 

 

                    894

 

 

 

                    786

 

Operating lease right-of-use assets

 

                 4,442

 

 

 

                 2,871

 

Lease security deposit

 

                    138

 

 

 

                    421

 

 Total assets 

 $

          719,738

 

 

 $

          776,151

 

       
Liabilities and stockholders' equity      
Current liabilities:      
 Accounts payable 

 $

            12,728

 

 

 $

              3,925

 

 Current operating lease liabilities 

 

                    941

 

 

 

                    863

 

 Accrued expenses 

 

                 7,605

 

 

 

               12,137

 

 Total current liabilities 

 

               21,274

 

 

 

               16,925

 

Warrant liability

 

                 1,633

 

 

 

               11,037

 

Non-current operating lease liabilities

 

                 3,752

 

 

 

                 2,192

 

 Total liabilities 

 

               26,659

 

 

 

               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 June 30, 2022 and December 31, 2021,       
 218,244,300 (Class A 217,244,300, 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 June 30, 2022 and December 31, 2021, respectively 

 

             919,011

 

 

 

             909,985

 

 Accumulated deficit 

 

            (218,954

)

 

 

            (162,803

)

 Accumulated other comprehensive income 

 

                (6,978

)

 

 

                (1,185

)

 Total stockholders' equity 

 

             693,079

 

 

 

             745,997

 

 Total liabilities and stockholders' equity 

 $

          719,738

 

 

 $

          776,151

 

       
 
NUVATION BIO INC. and Subsidiaries              
               
Consolidated Statements of Operations and Comprehensive Loss              
(In thousands, except per share data)              
  Three Months Ended June 30,   Six Months Ended June 30,

2022

 

2021

 

2022

 

2021

               
               
Operating expenses:              
Research and development 

 $

           28,922

 

 

 $

           14,034

 

 

 $

           49,650

 

 

 $

           29,913

 

General and administrative

 

8,948

 

 

 

6,400

 

 

 

16,411

 

 

 

11,005

 

Total operating expenses

 

              37,870

 

 

 

              20,434

 

 

 

              66,061

 

 

 

              40,918

 

  ��            
Loss from operations

 

             (37,870

)

 

 

             (20,434

)

 

 

             (66,061

)

 

 

             (40,918

)

               
Other income (expense):              
Interest income

 

841

 

 

 

776

 

 

 

1,798

 

 

 

1,214

 

Investment advisory fees

 

                 (215

)

 

 

                 (176

)

 

 

                 (384

)

 

 

                 (284

)

Change in fair value of warrant liability

 

                3,080

 

 

 

                   500

 

 

 

                9,404

 

 

 

                   207

 

Realized (loss) gain on marketable securities

 

                 (694

)

 

 

                      1

 

 

 

                 (908

)

 

 

                     46

 

Total other (expense) income, net

 

                3,012

 

 

 

                1,101

 

 

 

                9,910

 

 

 

                1,183

 

               
Loss before income taxes

 

             (34,858

)

 

 

             (19,333

)

 

 

             (56,151

)

 

 

             (39,735

)

               
Provision for income taxes

 

                       -

 

 

 

                       -

 

 

 

                       -

 

 

 

                       -

 

               
Net loss

 $

          (34,858

)

 

 $

          (19,333

)

 

 $

          (56,151

)

 

 $

          (39,735

)

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

 $

              (0.16

)

 

 $

              (0.09

)

 

 $

              (0.26

)

 

 $

              (0.21

)

Weighted average common shares outstanding, basic and diluted

 

            216,603

 

 

 

            204,017

 

 

 

            215,016

 

 

 

            186,933

 

               
Comprehensive loss:              
Net loss

 $

          (34,858

)

 

 $

          (19,333

)

 

 $

          (56,151

)

 

 $

          (39,735

)

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

 

                 (761

)

 

 

                 (224

)

 

 

               (5,793

)

 

 

                 (800

)

               
Comprehensive loss

 $

          (35,619

)

 

 $

          (19,557

)

 

 $

          (61,944

)

 

 $

          (40,535

)

               

 

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