NUVB Nuvation Bio Inc. Class A

8.17
+0.42  (+5%)
Previous Close 7.75
Open 7.75
52 Week Low 7.3
52 Week High 15.23
Market Cap $1,779,324,953
Shares 217,787,632
Float 85,095,142
Enterprise Value $1,695,680,769
Volume 1,117,526
Av. Daily Volume 720,466
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NUV-422
High-grade gliomas
Phase 1
Phase 1
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Latest News

  1. NEW YORK, Nov. 10, 2021 /PRNewswire/ -- 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 third quarter ended September 30, 2021, and provided a business update.

    "In the third quarter, Nuvation Bio continued to advance our lead cyclin-dependent kinase (CDK) 2/4/6 inhibitor program, with enrollment progressing in the ongoing Phase 1/2 study of NUV-422 for the treatment of adult patients with recurrent glioblastoma, malignant gliomas, hormone receptor-positive breast cancer and metastatic castration-resistant prostate cancer. We remain on track to report top-line data from the Phase 1 portion of the study in 2022," said David Hung, M.D., founder and chief executive officer of Nuvation Bio. "Additionally, we remain well capitalized to advance our full pipeline of novel oncology therapeutic candidates for difficult-to-treat cancers and look forward to providing clinical development updates."

    Recent Business Highlights

    • Enrollment ongoing in Phase 1/2 multiple expansion cohort study of NUV-422. During the third quarter of 2021, Nuvation Bio continued to enroll patients in the Phase 1/2 study of NUV-422, a CDK 2/4/6 inhibitor. The Company submitted a protocol amendment to the U.S. Food and Drug Administration (FDA) in the second quarter, expanding the study to include additional cohorts for patients with recurrent glioblastoma, hormone receptor-positive metastatic breast cancer (with and without brain metastases) and metastatic castration-resistant prostate cancer. Enrollment is ongoing and data from the Phase 1 portion of the study is expected in 2022.

    Second Quarter Financial Results

    As of September 30, 2021, Nuvation Bio had cash, cash equivalents and marketable securities of $791.8 million.

    For the three months ended September 30, 2021, research and development expenses were $17.1 million, compared to $8.6 million for the three months ended September 30, 2020. The increase was primarily due to a $5.3 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 $3.2 million increase in personnel-related costs driven by an increase in headcount and stock-based compensation.

    For the three months ended September 30, 2021, general and administrative expenses were $5.7 million, compared to $2.9 million for the three months ended September 30, 2020. 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 $1.1 million increase in insurance, a $0.3 million increase in other miscellaneous expenses offset by a $0.4 million decrease in professional fees and a $0.1 million decrease in legal fees.

    For the three months ended September 30, 2021, Nuvation Bio reported a net loss of $22.0 million, or $(0.11) per share. This compares to a net loss of $11.0 million, or $(0.12) per share, for the comparable period in 2020.

    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 six novel and 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 data. 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 provided for illustrative purposes only and are not intended to serve as, and must not be relied on as, a guarantee, an assurance, a prediction or a definitive statement of fact or probability. Actual events and circumstances are difficult or impossible to predict and will differ from assumptions. Many actual events and circumstances are beyond the control of Nuvation Bio. These forward-looking statements are subject to a number of risks and uncertainties, including those factors discussed in the Quarterly Report on Form 10-Q expected to be filed with the SEC on or about November 11, 2021, under the heading "Risk Factors," and other documents that Nuvation Bio has filed or will file with the SEC. If any of these risks materialize or Nuvation Bio's assumptions prove incorrect, actual results could differ materially from the results implied by these forward-looking statements. There may be additional risks that Nuvation Bio does not presently know, or that Nuvation Bio currently believes are immaterial, that could also cause actual results to differ from those contained in the forward-looking statements. In addition, forward-looking statements reflect Nuvation Bio's expectations, plans or forecasts of future events and views as of the date of this press release. Nuvation Bio anticipates that subsequent events and developments will cause Nuvation Bio's assessments to change. However, while Nuvation Bio may elect to update these forward-looking statements at some point in the future, Nuvation Bio specifically disclaims any obligation to do so. These forward-looking statements should not be relied upon as representing Nuvation Bio's assessments of any date subsequent to the date of this press release. Accordingly, undue reliance should not be placed upon the forward-looking statements.

    Nuvation Bio Investor Contact:

    Nuvation Bio Media Contact:

    Argot Partners

    Leo Vartorella

     

     

    NUVATION BIO INC. and Subsidiaries















    Condensed Balance Sheets







    (In thousands, except share and per share data)

    September 30,



    December 31,



    2021



    2020









    Assets















    Current assets:







     Cash and cash equivalents 

    $      344,631



    $        29,755

     Prepaid expenses 

    3,014



    914

     Marketable securities available-for-sale, at fair value 

    447,153



    185,997

     Interest receivable on marketable securities 

    1,814



    1,092

     Deferred financing costs 

    -



    2,925

     Total current assets 

    796,612



    220,683









     Property and equipment, net  

    758



    688









     Other assets: 







     Lease security deposit 

    421



    421









     Total assets 

    $      797,791



    $      221,792









     Liabilities and stockholders' equity 













     Current liabilities: 







     Accounts payable 

    $          5,163



    $          2,171

     Accrued expenses 

    8,145



    4,380

     Total current liabilities 

    13,308



    6,551

     Warrant liability 

    14,936



    -

     Deferred rent - non current 

    181



    157

     Total liabilities 

    28,425



    6,708









     Commitments and contingencies (Note 11) 















     Stockholders' equity 







     Class A and Class B common stock and additional paid in capital, $0.0001 par value per share; 







     1,060,000,000 shares authorized as of June 30, 2021 (Class A 1,000,000,000, Class B 60,000,000) 







     and 1,174,094,678 shares authorized as of December 31, 2020 (Class A 880,000,000, Class B 294,094,678); 







     217,776,232 (Class A 216,776,232, Class B 1,000,000) and 149,042,155 (Class A 91,397,142,  







     Class B 57,645,013) issued and outstanding as of September 30, 2021 and December 31, 2020, respectively 

    906,647



    289,482

     Accumulated deficit 

    (137,669)



    (75,955)

     Accumulated other comprehensive income 

    388



    1,557

     Total stockholders' equity 

    769,366



    215,084









     Total liabilities and stockholders' equity 

    $      797,791



    $      221,792

     

     

    NUVATION BIO INC. and Subsidiaries































    Condensed Statements of Operations and Comprehensive Loss 















    (In thousands, except per share data)

















    Three Months Ended September 30,



    Nine Months Ended September 30,



    2021



    2020



    2021



    2020

































    Operating expenses:















    Research and development 

    $            17,122



    $              8,627



    $            47,035



    $            23,267

    General and administrative

    5,669



    2,919



    16,674



    6,516

    Total operating expenses

    22,791



    11,546



    63,709



    29,783

















    Loss from operations

    (22,791)



    (11,546)



    (63,709)



    (29,783)

















    Other income (expense):















    Interest income

    847



    445



    2,061



    1,486

    Investment advisory fees

    (170)



    (52)



    (454)



    (168)

    Change in fair value of warrant liability

    125



    -



    332



    -

    Realized gain (loss) on marketable securities

    10



    119



    56



    86

    Total other (expense) income

    812



    512



    1,995



    1,404

















    Loss before income taxes

    (21,979)



    (11,034)



    (61,714)



    (28,379)

















    Provision for income taxes

    -



    -



    -



    -

















    Net loss

    $           (21,979)



    $           (11,034)



    $           (61,714)



    $           (28,379)

    Net loss attributable to common stockholders















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

    $               (0.11)



    $               (0.12)



    $               (0.32)



    $               (0.32)

    Weighted average common shares outstanding, basic and diluted

    207,101



    91,771



    193,730



    88,755

















    Comprehensive loss:















    Net loss

    $           (21,979)



    $           (11,034)



    $           (61,714)



    $           (28,379)

    Other comprehensive income, net of taxes:















    Change in unrealized (loss) gain on available-for-sale securities

    (369)



    (350)



    (1,169)



    1,400

















    Comprehensive loss

    $           (22,348)



    $           (11,384)



    $           (62,883)



    $           (26,979)

     

     

     

    Cision View original content to download multimedia:https://www.prnewswire.com/news-releases/nuvation-bio-reports-third-quarter-2021-financial-results-and-provides-business-update-301420403.html

    SOURCE Nuvation Bio, Inc.

    View Full Article Hide Full Article
  2. NEW YORK, Aug. 12, 2021 /PRNewswire/ -- 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 second quarter ended June 30, 2021, and provided a business update.  

    "The second quarter of 2021 marked multiple achievements for Nuvation Bio. With the appointment of David C. Hanley, Ph.D., as Chief Technical Operations Officer, we are advancing our supply chain, product development and manufacturing efforts. For our pipeline, we continue to enroll and dose patients in our ongoing Phase 1/2 study of NUV-422 and have recently expanded the study to include additional cohorts for patients with recurrent glioblastoma, hormone receptor-positive breast cancer and metastatic castration-resistant prostate cancer, further reinforcing the potential of NUV-422," said David Hung, M.D., founder and chief executive officer of Nuvation Bio. "We look forward to advancing our ongoing study of NUV-422, and the entirety of our pipeline of therapies for difficult-to-treat cancers, towards clinical development."

    Recent Business Highlights

    • Enrollment ongoing in Phase 1/2 multiple expansion cohort study of NUV-422. During the second quarter of 2021, Nuvation Bio submitted a protocol amendment to the U.S. Food and Drug Administration (FDA) to expand the population of its Phase 1/2 study of lead investigational compound, NUV-422, a cyclin-dependent kinase (CDK) 2/4/6 inhibitor. The expanded population will allow for enrollment of patients with recurrent glioblastoma, hormone receptor-positive metastatic breast cancer (with and without brain metastases) and metastatic castration-resistant prostate cancer. Enrollment is ongoing and data from the Phase 1 portion of the study is expected in 2022.



    • Appointment of David C. Hanley, Ph.D., as Chief Technical Operations Officer. In June 2021, Nuvation Bio announced the appointment of David C. Hanley, Ph.D., as Chief Technical Operations Officer, joining the Company's executive management team. In this capacity, Dr. Hanley will oversee all early- and late-stage pharmaceutical development and operations, including supply chain, product development and manufacturing efforts, and work closely on commercial planning with Quality, Regulatory Affairs, Clinical Development and Clinical Operations teams.

    Second Quarter Financial Results

    As of June 30, 2021, Nuvation Bio had cash, cash equivalents and marketable securities of $806.6 million.

    For the three months ended June 30, 2021, research and development expenses were $14.0 million, compared to $7.3 million for the three months ended June 30, 2020. The increase of $6.7 million was primarily due to a $4.7 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 $2.0 million increase in personnel-related costs driven by an increase in headcount and stock-based compensation.

    For the three months ended June 30, 2021, general and administrative expenses were $6.4 million, compared to $1.7 million for the three months ended June 30, 2020. The increase of $4.7 million was due to an increase in personnel-related costs driven by an increase in headcount and stock-based compensation, as well as increases in insurance, professional fees, other miscellaneous expenses and legal fees.

    For the three months ended June 30, 2021, Nuvation Bio reported a net loss of $19.3 million, or $(0.09) per share. This compares to a net loss of $8.6 million, or $(0.10) per share, for the comparable period in 2020.

    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 six novel and 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 timing of clinical trial data. 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 provided for illustrative purposes only and are not intended to serve as, and must not be relied on as, a guarantee, an assurance, a prediction or a definitive statement of fact or probability. Actual events and circumstances are difficult or impossible to predict and will differ from assumptions. Many actual events and circumstances are beyond the control of Nuvation Bio. These forward-looking statements are subject to a number of risks and uncertainties, including those factors discussed in the Quarterly Report on Form 10-Q filed with the SEC on August 12, 2021, under the heading "Risk Factors," and other documents that Nuvation Bio has filed or will file, with the SEC. If any of these risks materialize or Nuvation Bio's assumptions prove incorrect, actual results could differ materially from the results implied by these forward-looking statements. There may be additional risks that Nuvation Bio does not presently know, or that Nuvation Bio currently believes are immaterial, that could also cause actual results to differ from those contained in the forward-looking statements. In addition, forward-looking statements reflect Nuvation Bio's expectations, plans or forecasts of future events and views as of the date of this press release. Nuvation Bio anticipates that subsequent events and developments will cause Nuvation Bio's assessments to change. However, while Nuvation Bio may elect to update these forward-looking statements at some point in the future, Nuvation Bio specifically disclaims any obligation to do so. These forward-looking statements should not be relied upon as representing Nuvation Bio's assessments of any date subsequent to the date of this press release. Accordingly, undue reliance should not be placed upon the forward-looking statements.

    Nuvation Bio Investor Contact:

    Nuvation Bio Media Contact:

    Argot Partners

    Leo Vartorella

     

     

    NUVATION BIO INC. and Subsidiaries















    Condensed Balance Sheets







    (In thousands, except share and per share data)

    June 30,



    December 31,



    2021



    2020









    Assets















    Current assets:







     Cash and cash equivalents 

    $     449,533



    $       29,755

     Prepaid expenses 

    4,472



    914

     Marketable securities available-for-sale, at fair value 

    357,074



    185,997

     Interest receivable on marketable securities 

    1,997



    1,092

     Deferred financing costs 

    -



    2,925

     Total current assets 

    813,076



    220,683









     Property and equipment, net  

    766



    688









     Other assets: 







     Lease security deposit 

    421



    421









     Total assets 

    $     814,263



    $     221,792









     Liabilities and stockholders' equity 













     Current liabilities: 







     Accounts payable 

    $         4,497



    $         2,171

     Accrued expenses 

    5,593



    4,380

     Total current liabilities 

    10,090



    6,551

     Warrant liability 

    15,061



    -

     Deferred rent - non current 

    177



    157

     Total liabilities 

    25,328



    6,708









     Commitments and contingencies (Note 11) 















     Stockholders' equity 







     Class A and Class B common stock and additional paid in capital, $0.0001 par value per share; 







     1,060,000,000 shares authorized as of June 30, 2021 (Class A 1,000,000,000, Class B 60,000,000) 







     and 1,174,094,678 shares authorized as of December 31, 2020 (Class A 880,000,000, Class B 294,094,678); 







     217,759,082 (Class A 216,759,082, Class B 1,000,000) and 149,042,155 (Class A 91,397,142,  







     Class B 57,645,013) issued and outstanding as of June 30, 2021 and December 31, 2020, respectively 

    903,868



    289,482

     Accumulated deficit 

    (115,690)



    (75,955)

     Accumulated other comprehensive income 

    757



    1,557

     Total stockholders' equity 

    788,935



    215,084









     Total liabilities and stockholders' equity 

    $     814,263



    $     221,792

     

    NUVATION BIO INC. and Subsidiaries































    Condensed Statements of Operations and Comprehensive Loss















    (In thousands, except per share data)

















    Three Months Ended June 30,



    Six Months Ended June 30,



    2021



    2020



    2021



    2020

































    Operating expenses:















    Research and development 

    $           14,034



    $            7,345



    $           29,913



    $           14,640

    General and administrative

    6,400



    1,672



    11,005



    3,597

    Total operating expenses

    20,434



    9,017



    40,918



    18,237

















    Loss from operations

    (20,434)



    (9,017)



    (40,918)



    (18,237)

















    Other income (expense):















    Interest income

    776



    522



    1,214



    1,041

    Investment advisory fees

    (176)



    (56)



    (284)



    (116)

    Change in fair value of warrant liability

    500



    -



    207



    -

    Realized gain (loss) on marketable securities

    1



    (48)



    46



    (33)

    Total other (expense) income

    1,101



    418



    1,183



    892

















    Loss before income taxes

    (19,333)



    (8,599)



    (39,735)



    (17,345)

















    Provision for income taxes

    -



    -



    -



    -

















    Net loss

    $         (19,333)



    $           (8,599)



    $         (39,735)



    $         (17,345)

    Net loss attributable to common stockholders















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

    $            (0.09)



    $            (0.10)



    $            (0.21)



    $            (0.20)

    Weighted average common shares outstanding, basic and diluted

    204,017



    88,745



    186,933



    87,230

















    Comprehensive loss:















    Net loss

    $         (19,333)



    $           (8,599)



    $         (39,735)



    $         (17,345)

    Other comprehensive income, net of taxes:















    Change in unrealized (loss) gain on available-for-sale securities

    (224)



    931



    (800)



    1,750

















    Comprehensive loss

    $         (19,557)



    $           (7,668)



    $         (40,535)



    $         (15,595)

     

    Cision View original content to download multimedia:https://www.prnewswire.com/news-releases/nuvation-bio-reports-second-quarter-2021-financial-results-and-provides-business-update-301354696.html

    SOURCE Nuvation Bio, Inc.

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