SRRA Sierra Oncology Inc.

11.4
-0.55  -5%
Previous Close 11.95
Open 11.57
52 Week Low 8.545
52 Week High 22
Market Cap $118,511,345
Shares 10,395,732
Float 3,184,411
Enterprise Value $1,441,997
Volume 17,322
Av. Daily Volume 24,310
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Upcoming Catalysts

Drug Stage Catalyst Date
Momelotinib - MOMENTUM
Myelofibrosis
Phase 3
Phase 3
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Drug Pipeline

Drug Stage Notes
SRA737 + Low-Dose Gemcitabine
Solid Tumors
Phase 1/2
Phase 1/2
Phase 1/2 preliminary data of ORR 30% at ASCO June 1, 2019. 8am.
SRA737
Advanced Solid Tumors or Non-Hodgkin's Lymphoma (NHL)
Phase 1/2
Phase 1/2
Phase 1/2 preliminary data ASCO June 1, 2019 noted stable disease rate of 32%.
PNT2258
Richter's Transformation
Phase 2
Phase 2
Development suspended - June 2016
PNT2258
Relapsed or refractory diffuse large B-cell lymphoma (DLBCL) - cancer
Phase 2
Phase 2
Discontinued following poor efficacy - June 2016

Latest News

  1. VANCOUVER, BC, Sept. 14, 2020 /PRNewswire/ - Sierra Oncology, Inc. (SRRA), a late-stage drug development company focused on the registration and commercialization of momelotinib, a JAK1, JAK2 & ACVR1 inhibitor for the treatment of myelofibrosis, today announced that Dr. Stephen Dilly, President and CEO, will present an overview of the company at two investor conferences in September: the H.C. Wainwright 22nd Annual Global Investment Conference and the Oppenheimer Fall Healthcare Life Sciences & MedTech Summit.

    H.C. Wainwright Annual Global Investment Conference

    Date:

    Wednesday, Sept 16

    Time:

    11:00 am ET

    Webcast link:

    https://wsw.com/webcast/hcw7/srra/1618264

     

    Oppenheimer Fall Healthcare Life Sciences & MedTech Summit

    Date:

    Monday, September

    VANCOUVER, BC, Sept. 14, 2020 /PRNewswire/ - Sierra Oncology, Inc. (SRRA), a late-stage drug development company focused on the registration and commercialization of momelotinib, a JAK1, JAK2 & ACVR1 inhibitor for the treatment of myelofibrosis, today announced that Dr. Stephen Dilly, President and CEO, will present an overview of the company at two investor conferences in September: the H.C. Wainwright 22nd Annual Global Investment Conference and the Oppenheimer Fall Healthcare Life Sciences & MedTech Summit.

    H.C. Wainwright Annual Global Investment Conference

    Date:

    Wednesday, Sept 16

    Time:

    11:00 am ET

    Webcast link:

    https://wsw.com/webcast/hcw7/srra/1618264

     

    Oppenheimer Fall Healthcare Life Sciences & MedTech Summit

    Date:

    Monday, September 21

    Time:

    11:40 am ET

    Webcast Link:

    https://wsw.com/webcast/oppenheimer5/srra/2734488 

    Replays of these presentations will be available on the Investors section of Sierra's corporate website in the Events & Webcast tab.

    About Sierra Oncology

    Sierra Oncology is a late stage drug development company focused on achieving the successful registration and commercialization of momelotinib, a potent, selective and orally-bioavailable JAK1, JAK2 & ACVR1 inhibitor with a differentiated mechanism of action that enables it to potentially address all three key drivers of myelofibrosis: anemia, constitutional symptoms and enlarged spleen. More than 1,200 subjects have received momelotinib since clinical studies began in 2009, including more than 820 patients treated for myelofibrosis.

    Sierra has launched MOMENTUM, a randomized double-blind Phase 3 clinical trial designed to enroll 180 myelofibrosis patients who are symptomatic and anemic, and who have been treated previously with a JAK inhibitor. The U.S. Food and Drug Administration has granted Fast Track designation to momelotinib. Momelotinib is protected by patents anticipated to provide potential exclusivity to 2040 in the United States and Europe (inclusive of potential Patent Term Extension or Supplementary Protection Certificate).

    For more information, please visit www.sierraoncology.com.

    Cautionary Note on Forward-Looking Statements

    This press release contains forward-looking statements within the meaning of the "safe harbor" provisions of the Private Securities Litigation Reform Act of 1995, including, but not limited to, statements regarding Sierra Oncology's expectations from current data, anticipated clinical development activities, expected timing and success of enrollment of MOMENTUM and potential benefits of momelotinib. All statements other than statements of historical fact are statements that could be deemed forward-looking statements. These statements are based on management's current expectations and beliefs and are subject to a number of risks, uncertainties and assumptions that could cause actual results to differ materially from those described in the forward-looking statements. Such forward-looking statements are subject to risks and uncertainties, including, among others, the risk that Sierra Oncology's cash resources may be insufficient to fund its current operating plans and it may be unable to raise additional capital when needed, the risk that disruptions and impacts of COVID-19 will be significant and lengthy, Sierra Oncology may be unable to successfully develop and commercialize momelotinib, momelotinib may not demonstrate safety and efficacy or otherwise produce positive results, Sierra Oncology may experience delays in the clinical development of momelotinib, Sierra Oncology may be unable to acquire additional assets to build a pipeline of additional product candidates, Sierra Oncology's third-party manufacturers may cause its supply of materials to become limited or interrupted or fail to be of satisfactory quantity or quality, Sierra Oncology may be unable to obtain and enforce intellectual property protection for its technologies and momelotinib and the other factors described under the heading "Risk Factors" set forth in Sierra Oncology's filings with the Securities and Exchange Commission from time to time. Sierra Oncology undertakes no obligation to update the forward-looking statements contained herein or to reflect events or circumstances occurring after the date hereof, other than as may be required by applicable law.

    Cision View original content:http://www.prnewswire.com/news-releases/sierra-to-present-at-september-investor-conferences-301128608.html

    SOURCE Sierra Oncology

    View Full Article Hide Full Article
  2. - MOMENTUM Phase 3 clinical trial enrollment on track; top-line data anticipated in H1 2022 -
    - Updated analyses comparing symptomatic benefits of momelotinib to ruxolitinib from the SIMPLIFY-1 Phase 3 trial anticipated in late 2020 -

    VANCOUVER, BC, Aug. 6, 2020 /PRNewswire/ - Sierra Oncology, Inc. (SRRA), a late-stage drug development company focused on the registration and commercialization of momelotinib, a JAK1, JAK2 & ACVR1 inhibitor with a potentially differentiated therapeutic profile for the treatment of myelofibrosis, today reported its financial and operational results for the second quarter ended June 30, 2020.

    "We believe momelotinib, if approved, may provide an important treatment option for underserved myelofibrosis patients…

    - MOMENTUM Phase 3 clinical trial enrollment on track; top-line data anticipated in H1 2022 -

    - Updated analyses comparing symptomatic benefits of momelotinib to ruxolitinib from the SIMPLIFY-1 Phase 3 trial anticipated in late 2020 -

    VANCOUVER, BC, Aug. 6, 2020 /PRNewswire/ - Sierra Oncology, Inc. (SRRA), a late-stage drug development company focused on the registration and commercialization of momelotinib, a JAK1, JAK2 & ACVR1 inhibitor with a potentially differentiated therapeutic profile for the treatment of myelofibrosis, today reported its financial and operational results for the second quarter ended June 30, 2020.

    "We believe momelotinib, if approved, may provide an important treatment option for underserved myelofibrosis patients, in particular those with anemia and thrombocytopenia, and as such is well-positioned to generate significant value," said Dr. Stephen Dilly, President and CEO of Sierra Oncology. "During the second quarter, we continued to advance the MOMENTUM Phase 3 trial and are on track to deliver top-line results in the first half of 2022. In anticipation of these pivotal data, we are preparing for the regulatory submission process and the potential commercialization of momelotinib, and subsequent to the end of the quarter, we substantially strengthened our senior management team to support these activities."

    "We made significant progress during the first half of 2020 operationalizing the global MOMENTUM Phase 3 trial and, while the potential impact of the COVID-19 pandemic continues to be uncertain, we are pleased with the current pace of enrollment," said Dr. Barbara Klencke, Chief Development Officer, Sierra Oncology. "During the EHA virtual conference, two world-leading physicians in the treatment of myelofibrosis reported long-term data that continue to reinforce momelotinib's differentiated durability, safety and efficacy profile. We plan to report updated analyses in late 2020 comparing the symptomatic benefits of momelotinib to ruxolitinib from the SIMPLIFY-1 Phase 3 trial that will further emphasize momelotinib's differentiated and competitive profile."

    "As the MOMENTUM trial ramps up, we've managed our resources prudently and continue to anticipate our current cash runway will extend beyond top-line data and into the second half of 2022, subject to the potential impact of COVID-19," said Mr. Sukhi Jagpal, Chief Financial Officer of Sierra Oncology. "In addition, our Series B warrants will expire on the 75th day following the announcement of top-line data and may only be exercised by paying the exercise price in cash, which would amount to approximately $34.0 million in proceeds to the Company if fully exercised.  We are also starting to explore non-dilutive options that could provide additional capital to support our North American commercialization strategy."

    Second Quarter Highlights:

    • Hosted an Analyst & Investor Call featuring a presentation by renowned myelofibrosis expert Dr. Ruben Mesa, Director of the Mays Cancer Center, home to UT Health San Antonio MD Anderson Cancer Center, who discussed momelotinib's ability to address anemia and transfusion dependency, two critical unmet medical needs in treating patients with myelofibrosis.
    • Reported favorable Long-Term Safety and Dose Intensity data for momelotinib from more than 550 patients across the two previously conducted SIMPLIFY Phase 3 studies and their subsequent ongoing extended treatment periods, at the 25th EHA Virtual Congress.
      • Professor Claire Harrison, Guy's and St. Thomas' NHS Foundation Trust, London, United Kingdom presented a poster on the long-term safety profile of momelotinib, which demonstrated a lack of emergent or cumulative toxicity with extended daily administration. More than 90 SIMPLIFY-1 and SIMPLIFY-2 patients continued to receive momelotinib for 3.5 years or longer. Patients treated with momelotinib experienced rapid and sustained increases in hemoglobin, in contrast to the significant decrease in hemoglobin for patients receiving ruxolitinib. Patients treated with momelotinib also experienced significantly higher mean platelet counts compared to those receiving ruxolitinib. Importantly, patients who switched from ruxolitinib to momelotinib also achieved a sustained improvement in hemoglobin in both studies, and platelets in SIMPLIFY-1.
      • Dr. Vikas Gupta, Princess Margaret Cancer Centre, Toronto, Canada, presented a poster highlighting the sustained dose intensity and prolonged clinical activity of momelotinib across the continuum of JAK inhibitor naïve and previously JAK inhibitor treated myelofibrosis patients. While the starting doses for ruxolitinib were often attenuated due to low platelets, further reductions in dose intensity were also commonly required for ruxolitinib. In contrast, momelotinib was initiated at full dose for all patients enrolled to the SIMPLIFY studies and high dose intensity was maintained in the majority over extended dosing durations. Patients who switched from ruxolitinib to momelotinib saw an immediate and sustained improvement in dose intensity.
      • The data from the two interrelated presentations suggest that the favorable effect on hemoglobin and platelets allows momelotinib to be initiated at high dose intensity and maintained at high dose intensity over extended durations while retaining a favorable long-term safety profile. Notably, some patients continue to receive momelotinib 10 years after enrolling in the initial momelotinib Phase 2 trials, while 90 Phase 3 SIMPLIFY patients who enrolled into those trials 4 to 6 years ago continue to receive momelotinib, suggesting that the dosing and safety profile contributes to momelotinib's potential ability to provide sustained benefits over extended durations.

    Second Quarter 2020 Financial Results (all amounts reported in U.S. currency)

    Research and development expenses were $10.2 million for the three months ended June 30, 2020 compared to $11.7 million for the three months ended June 30, 2019. The decrease was primarily due to a $2.1 million decrease in clinical trial, third-party manufacturing, research and preclinical costs for SRA737, a $1.1 million decrease in personnel-related and allocated overhead costs, and a $0.9 million decrease in third-party manufacturing costs for momelotinib. These decreases were partially offset by a $2.6 million increase in clinical trial and development costs for momelotinib. Research and development expenses included non-cash stock-based compensation of $0.9 million and $1.2 million for the three months ended June 30, 2020 and 2019, respectively.

    Research and development expenses were $21.8 million for the six months ended June 30, 2020, compared with $21.9 million for the six months ended June 30, 2019. The decrease was primarily due to a $5.2 million decrease in clinical trial, third-party manufacturing, research and preclinical costs for SRA737, a $2.1 million decrease in personnel-related and allocated overhead costs, and a $0.6 million decrease in third-party manufacturing costs for momelotinib. These decreases were offset by a $6.3 million increase in clinical trial and development costs for momelotinib, and a non-cash charge of $1.5 million pertaining to the change in fair value of an obligation to issue common stock and a warrant to Gilead Sciences, Inc. (Gilead), which were issued during the first quarter of 2020. Research and development expenses included non-cash stock-based compensation of $1.5 million and $2.4 million for the six months ended June 30, 2020 and 2019, respectively.

    General and administrative expenses were $6.3 million for the three months ended June 30, 2020, compared to $3.5 million for the three months ended June 30, 2019. The increase was primarily due to a non-cash $2.2 million stock-based compensation charge and a $0.6 million severance charge pertaining to an executive resignation. General and administrative expenses included non-cash stock-based compensation of $2.7 million and $0.5 million for the three months ended June 30, 2020 and 2019, respectively.

    General and administrative expenses were $10.8 million for the six months ended June 30, 2020, compared to $6.8 million for the six months ended June 30, 2019. The increase was primarily due to a $3.0 million increase in personnel-related and allocated overhead costs, including a non-cash $2.2 million stock-based compensation charge noted above and $1.0 million of severance charges, offset by a decrease of $0.2 million in other personnel-related and allocated overhead costs. There was also an increase of $1.0 million in professional fees, including pre-commercial planning costs for momelotinib. General and administrative expenses included non-cash stock-based compensation of $3.1 million and $1.0 million for the six months ended June 30, 2020 and 2019, respectively.

    Other income (expense), net was $24,000 of other expense, net for the three months ended June 30, 2020, compared to $0.3 million of other income, net for the three months ended June 30, 2019. The difference was primarily attributable to a decrease in interest income due to lower interest rates. Other income (expense), net was $15.7 million of other expense, net for the six months ended June 30, 2020, compared to $0.7 million of other income, net for the six months ended June 30, 2019. The difference was primarily attributable to a non-cash charge of $16.2 million related to the change in fair value of warrant liabilities which were reclassified to equity in January 2020.

    For the three months ended June 30, 2020, Sierra incurred a GAAP net loss of $16.5 million compared to a GAAP net loss of $14.9 million for the months ended June 30, 2019. For the six months ended June 30, 2020, Sierra incurred a GAAP net loss of $48.4 million compared to a GAAP net loss of $27.9 million for the six months ended June 30, 2019. The GAAP net loss for the six months ended June 30, 2020 includes a non-cash charge of $16.2 million related to the change in fair value of warrant liabilities included in other income (expense), net and a $1.5 million non-cash charge pertaining to the obligation to issue securities to Gilead included in research and development expenses as mentioned above.

    Non-GAAP adjusted net loss was $12.8 million for the three months ended June 30, 2020, compared with a non-GAAP adjusted net loss of $13.1 million for the three months ended June 30, 2019. Non-GAAP adjusted net loss for the three months ended June 30, 2020 and 2019 excludes expenses related to stock-based compensation. For the six months ended June 30, 2020, Sierra incurred a non-GAAP adjusted net loss of $26.1 million compared to a non-GAAP adjusted net loss of $24.5 million for the six months ended June 30, 2019. Non-GAAP adjusted net loss for the six months ended June 30, 2020 excludes expenses related to the change in fair value of warrant liabilities, the change in fair value of the securities issuance obligation, and stock-based compensation. Non-GAAP adjusted net loss for the six months ended June 30, 2019 excludes expenses related to stock-based compensation. See "Non-GAAP Financial Measures" and "Reconciliation of GAAP to Non-GAAP Financial Measures" below for a reconciliation of this GAAP and non-GAAP financial measure.

    Cash and cash equivalents totaled $123.2 million as of June 30, 2020, compared to $147.5 million as of December 31, 2019.

    As of June 30, 2020, there were 10,395,732 total shares of common stock outstanding and warrants to purchase 11,102,251 shares of common stock, with an exercise price equal to $13.20 per share. There were 2,351,055 shares issuable upon exercise of stock options and an additional warrant to purchase 1,839 shares.

    About Sierra Oncology

    Sierra Oncology is a late stage drug development company focused on achieving the successful registration and commercialization of momelotinib, a potent, selective and orally-bioavailable JAK1, JAK2 & ACVR1 inhibitor with a differentiated mechanism of action that enables it to potentially address all three key drivers of myelofibrosis: anemia, constitutional symptoms and enlarged spleen. Momelotinib's therapeutic profile targets the underserved myelofibrosis patient population, in particular those with anemia and thrombocytopenia. More than 1,200 subjects have received momelotinib since clinical studies began in 2009, including more than 820 patients treated for myelofibrosis.

    Sierra has launched MOMENTUM, a randomized double-blind Phase 3 clinical trial designed to enroll 180 myelofibrosis patients who are symptomatic and anemic, and who have been treated previously with a JAK inhibitor. The U.S. Food and Drug Administration has granted Fast Track designation to momelotinib. Momelotinib is protected by patents anticipated to provide potential exclusivity to 2040 in the United States and Europe (inclusive of potential Patent Term Extension or Supplementary Protection Certificate).

    For more information, please visit www.sierraoncology.com.

    Cautionary Note on Forward-Looking Statements

    This press release contains forward-looking statements within the meaning of the "safe harbor" provisions of the Private Securities Litigation Reform Act of 1995, including, but not limited to, statements regarding Sierra Oncology's expectations from current data, anticipated clinical development activities, impact of the COVID-19 pandemic on clinical trial plans, including enrollment and site initiations, expected timing of release of further momelotinib analysis, expected timing and success of enrollment of MOMENTUM, potential benefits of momelotinib, and Sierra Oncology's capitalization and sufficiency of its capital resources. All statements other than statements of historical fact are statements that could be deemed forward-looking statements. These statements are based on management's current expectations and beliefs and are subject to a number of risks, uncertainties and assumptions that could cause actual results to differ materially from those described in the forward-looking statements. Such forward-looking statements are subject to risks and uncertainties, including, among others, the risk that Sierra Oncology's cash resources may be insufficient to fund its current operating plans and it may be unable to raise additional capital when needed, the risk that disruptions and impacts of COVID-19 will be significant and lengthy, Sierra Oncology may be unable to successfully develop and commercialize momelotinib, momelotinib may not demonstrate safety and efficacy or otherwise produce positive results, Sierra Oncology may experience delays in the clinical development of momelotinib, Sierra Oncology may be unable to acquire additional assets to build a pipeline of additional product candidates, Sierra Oncology's third-party manufacturers may cause its supply of materials to become limited or interrupted or fail to be of satisfactory quantity or quality, Sierra Oncology may be unable to obtain and enforce intellectual property protection for its technologies and momelotinib and the other factors described under the heading "Risk Factors" set forth in Sierra Oncology's filings with the Securities and Exchange Commission from time to time. Sierra Oncology undertakes no obligation to update the forward-looking statements contained herein or to reflect events or circumstances occurring after the date hereof, other than as may be required by applicable law. 

    SIERRA ONCOLOGY, INC.

    Condensed Consolidated Balance Sheets

    (unaudited)

    (in thousands)





    June 30,

    2020





    December 31,

    2019

    ASSETS











    CURRENT ASSETS:











    Cash and cash equivalents

    $

    123,233



    $

    147,528

    Prepaid expenses and other current assets



    1,392





    2,369

    Total current assets



    124,625





    149,897

    Property and equipment, net



    97





    113

    Operating lease right-of-use asset



    504





    589

    Other assets



    667





    729

    TOTAL ASSETS

    $

    125,893



    $

    151,328













    LIABILITIES AND STOCKHOLDERS' EQUITY











    CURRENT LIABILITIES:











    Accrued and other liabilities

    $

    6,698



    $

    7,170

    Accounts payable



    1,983





    1,019

    Deferred revenue



    300





    -

    Warrant liabilities



    -





    45,935

    Securities issuance obligation



    -





    10,485

    Total current liabilities



    8,981





    64,609

    Operating lease liability



    261





    374

    TOTAL LIABILITIES



    9,242





    64,983













    STOCKHOLDERS' EQUITY:























    Preferred stock



    -





    1

    Common stock



    10





    74

    Additional paid-in capital



    930,702





    851,957

    Accumulated deficit



    (814,061)





    (765,687 )

    TOTAL STOCKHOLDERS' EQUITY



    116,651





    86,345













    TOTAL LIABILITIES AND STOCKHOLDERS' EQUITY

    $

    125,893



    $

    151,328

     

    SIERRA ONCOLOGY, INC.

    Condensed Consolidated Statements of Operations

    (unaudited)

    (in thousands, except share and per share data)





    Three Months Ended

    June 30,





    Six Months Ended

    June 30,



    2020



    2019



    2020



    2019

























    Operating expenses:























    Research and development

    $

    10,189



    $

    11,728



    $

    21,780



    $

    21,865

    General and administrative



    6,260





    3,479





    10,804





    6,844

    Total operating expenses



    16,449





    15,207





    32,584





    28,709

    Loss from operations



    (16,449)





    (15,207)





    (32,584)





    (28,709)

    Other income (expense), net























    Changes in fair value of warrant liabilities



    -





    -





    (16,240)





    -

    Other income (expense), net



    (24)





    348





    517





    673

    Total other income (expense), net



    (24)





    348





    (15,723)





    673

    Loss before provision for (benefit from) income taxes, net



    (16,473)





    (14,859)





    (48,307)





    (28,036)

    Provision for (benefit from) income taxes, net



    (11)





    19





    67





    (126)

    Net loss

    $

    (16,462)



    $

    (14,878)



    $

    (48,374)



    $

    (27,910)

    Net loss per common share, basic and diluted

    $

    (1.58)



    $

    (7.97)



    $

    (4.71)



    $

    (14.97)

    Weighted-average shares used in computing net loss per common

    share, basic and diluted



    10,395,732





    1,867,207





    10,276,180





    1,864,684

    Non-GAAP Financial Measures

    In addition to operating results as calculated in accordance with GAAP, Sierra Oncology uses certain non-GAAP financial measures when evaluating operational performance. The following table presents the company's net loss and net loss per common share calculated in accordance with GAAP and as adjusted to remove the impact of certain non-cash charges. Sierra Oncology's management believes that these non-GAAP financial measures are useful to enhance understanding of the company's financial performance, and are more indicative of its operational performance and facilitate a better comparison among fiscal periods.

    These non-GAAP financial measures are not, and should not be viewed as, substitutes for GAAP reporting measures. These non-GAAP financial measures are not based on any comprehensive set of accounting rules or principles, differ from GAAP measures with the same names, and may differ from non-GAAP financial measures with the same or similar names that are used by other companies. Sierra Oncology believes that non-GAAP financial measures should only be used to evaluate its results of operations in conjunction with the corresponding GAAP financial measures. Sierra Oncology encourages investors to carefully consider its results under GAAP, as well as the reconciliations between these presentations, to more fully understand our business.

    Non-GAAP adjusted net loss and non-GAAP adjusted net loss per share exclude changes in fair value for warrant liabilities, changes in fair value for a securities issuance obligation and stock-based compensation. Sierra Oncology excludes changes in fair value of warrant liabilities because it is a non-cash expense and has no direct correlation to the operation of its business. Sierra Oncology excludes a non-cash charge pertaining to the changes in fair value of an obligation to issue common stock and a warrant to Gilead because it is a non-cash expense. Sierra Oncology excludes non-cash stock-based compensation expense from its non-GAAP financial measures because it believes that excluding this item provides meaningful supplemental information regarding operational performance. In particular, companies calculate stock-based compensation expense using a variety of valuation methodologies and subjective assumptions.

    SIERRA ONCOLOGY, INC.

    Reconciliation of GAAP to Non-GAAP Financial Measures

    (unaudited)

    (in thousands, except share and per share data)

    A reconciliation between GAAP net loss to non-GAAP adjusted net loss and GAAP net loss per common share to non-GAAP adjusted net loss per common share:



    Three Months Ended

    June 30,



    Six Months Ended

    June 30,



    2020



    2019



    2020



    2019

















    GAAP net loss

    $

    (16,462)



    $

    (14,878)



    $

    (48,374)



    $

    (27,910)

    Adjustments:























    Changes in fair value of warrant liabilities (1)

    -





    -





    16,240





    -

    Changes in fair value to securities issuance obligation (2)



    -





    -





    1,485





    -

    Stock-based compensation (3)



    3,617





    1,758





    4,535





    3,457

    Non-GAAP adjusted net loss

    $

    (12,845)



    $

    (13,120)



    $

    (26,114)



    $

    (24,453)

























    GAAP net loss per common share, basic and diluted

    $

    (1.58)



    $

    (7.97)



    $

    (4.71)



    $

    (14.97)

    Adjustment to net loss per common share



    0.34





    0.94





    2.17





    1.86

    Non-GAAP adjusted net loss per common share, basic and diluted

    $

    (1.24)



    $

    (7.03)



    $

    (2.54)



    $

    (13.11)

    Weighted-average shares used in computing net loss per common

    share, basic and diluted



    10,395,732





    1,867,207





    10,276,180





    1,864,684

























    (1)

    To reflect a non-cash charge to other income (expense), net for the changes in fair value of warrant liabilities.

    (2)

    To reflect a non-cash charge to research and development expense for the changes in fair value pertaining to the obligation to issue common stock and a warrant to Gilead.

    (3)

    To reflect a non-cash stock-based compensation charge to research and development expense and general and administrative expense.

     

    Cision View original content:http://www.prnewswire.com/news-releases/sierra-oncology-reports-second-quarter-2020-results-301107154.html

    SOURCE Sierra Oncology

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  3. REDWOOD CITY, Calif., June 16, 2020 (GLOBE NEWSWIRE) -- Codexis, Inc. (NASDAQ:CDXS), a leading protein engineering company and developer of high-performance enzymes, announces the election of new independent directors, Alison Moore, Ph.D. and Stephen Dilly, MBBS, Ph.D. at the company's 2020 Annual Meeting of Stockholders held earlier today.

    "We are delighted to welcome these two highly qualified professionals to our board, both of whom bring exceptional experience in biotherapeutics development and commercialization at a time when we are increasing our focus on this business segment," said Bernard J. Kelley, Codexis Chairman.

    Dr. Moore brings to Codexis significant experience as a biotechnology and pharmaceutical executive, including an…

    REDWOOD CITY, Calif., June 16, 2020 (GLOBE NEWSWIRE) -- Codexis, Inc. (NASDAQ:CDXS), a leading protein engineering company and developer of high-performance enzymes, announces the election of new independent directors, Alison Moore, Ph.D. and Stephen Dilly, MBBS, Ph.D. at the company's 2020 Annual Meeting of Stockholders held earlier today.

    "We are delighted to welcome these two highly qualified professionals to our board, both of whom bring exceptional experience in biotherapeutics development and commercialization at a time when we are increasing our focus on this business segment," said Bernard J. Kelley, Codexis Chairman.

    Dr. Moore brings to Codexis significant experience as a biotechnology and pharmaceutical executive, including an extensive background in biomanufacturing. She is Chief Technical Officer of Allogene Therapeutics, a pioneering clinical-stage company advancing CAR-T therapies. Prior to Allogene she spent a total of 20 years at Amgen, most recently as Senior Vice President, Process Development, and including roles in Supply Chain and Manufacturing. Dr. Moore also has experience at Genentech as a Director in Chemistry, Manufacturing and Controls, and Regulatory Affairs. Dr. Moore holds a bachelor's degree in Pharmacology with Honors and a Ph.D. in Cell Biology from Manchester University, England.

    Dr. Dilly brings to Codexis three decades of executive management experience overseeing the development and commercialization of a range of novel therapeutics addressing multiple human disease conditions within both smaller and larger biotechnology companies. In May 2020 he was appointed CEO and director of the drug development company Sierra Oncology, Inc. (NASDAQ:SRRA). He previously served as CEO and director of Aimmune Therapeutics from 2014 to 2018 where he led the company through its successful IPO in 2015, and its landmark Phase 3 study for its lead product, Palforzia™, in early 2018.  Dr Dilly's earlier experiences include several tenures as CEO and director of private companies, as well as executive roles at Chiron, Genentech, SmithKline Beecham, and Pfizer. Dr. Dilly received an MBBS and a Ph.D. in cardiac physiology from the University of London.

    In addition to the election of Drs. Moore and Dilly, Codexis stockholders also re-elected Dr. Patrick Yang earlier today to continue to serve on the board.

    About Codexis, Inc.

    Codexis is a leading protein engineering company that applies its proprietary CodeEvolver® technology to discover, develop and commercialize proteins for a variety of applications, including as biocatalysts for the commercial manufacture of pharmaceuticals and fine chemicals, industrial enzymes, enzymes for use in molecular biology, diagnostics and other life science applications, and enzymes and other proteins as biotherapeutics. Codexis' proven technology platform delivers value by enabling highly targeted and application-relevant improvements in protein performance. For more information, see www.codexis.com.

    Forward-Looking Statements

    To the extent that statements contained in this press release are not descriptions of historical facts regarding Codexis, they are forward-looking statements reflecting the current beliefs and expectations of management made pursuant to the safe harbor provisions of the Private Securities Litigation Reform Act of 1995. You should not place undue reliance on these forward-looking statements because they involve known and unknown risks, uncertainties and other factors that are, in some cases, beyond Codexis' control and that could materially affect actual results. Factors that could materially affect actual results include, among others: Codexis' dependence on its licensees and collaborators; Codexis' dependence on a limited number of products and customers; and potential adverse effects to Codexis' business if its products are not received well in the markets. Additional information about factors that could materially affect actual results can be found in Codexis' Annual Report on Form 10-K filed with the Securities and Exchange Commission ("SEC") on February 28, 2020 and Form 10-Q filed with the SEC on May 8, 2020, including under the caption "Risk Factors" and in Codexis' other periodic reports filed with the SEC. Codexis expressly disclaims any intent or obligation to update these forward-looking statements, except as required by law.

    Contact:

    LHA Investor Relations

    Jody Cain

    310-691-7100

    Photos accompanying this announcement are available at

    https://www.globenewswire.com/NewsRoom/AttachmentNg/18fa030d-90cc-4d54-9f1a-3e620d6ec3c6

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  4. - Data presented at the 25th European Hematology Association (EHA) Virtual Congress further demonstrate the potential anemia benefits and favorable hematological safety profile of momelotinib -
    - Long-term tolerability facilitates sustained dose intensity and prolonged clinical activity; longest ongoing treatment now extends to 10 years -

    VANCOUVER, BC, June 12, 2020 /PRNewswire/ - Sierra Oncology, Inc. (NASDAQ:SRRA), a late-stage drug development company focused on the registration and commercialization of momelotinib, a JAK1, JAK2 & ACVR1 inhibitor with a potentially differentiated therapeutic profile for the treatment of myelofibrosis, announced that Long-Term Safety and Dose Intensity data for momelotinib are being presented today in two…

    - Data presented at the 25th European Hematology Association (EHA) Virtual Congress further demonstrate the potential anemia benefits and favorable hematological safety profile of momelotinib -

    - Long-term tolerability facilitates sustained dose intensity and prolonged clinical activity; longest ongoing treatment now extends to 10 years -

    VANCOUVER, BC, June 12, 2020 /PRNewswire/ - Sierra Oncology, Inc. (NASDAQ:SRRA), a late-stage drug development company focused on the registration and commercialization of momelotinib, a JAK1, JAK2 & ACVR1 inhibitor with a potentially differentiated therapeutic profile for the treatment of myelofibrosis, announced that Long-Term Safety and Dose Intensity data for momelotinib are being presented today in two posters at the 25th European Hematology Association (EHA) Virtual Congress.

    More than 820 patients with myelofibrosis have received momelotinib during its development, including a number of patients who remain on treatment since the start of the original Phase 2 studies initiated a decade ago. One of these patients will reach a major milestone this week, having received momelotinib therapy for 10 years, highlighting the relevance of the long-term dosing and safety data for momelotinib being presented this week at EHA. The data presented at EHA draw from more than 550 patients across the two previously conducted SIMPLIFY Phase 3 studies and their subsequent ongoing extended treatment periods. More than 90 SIMPLIFY-1 and SIMPLIFY-2 patients continued to receive momelotinib for 3.5 years or longer.

    "Consistent with prior data, and reflecting momelotinib's differentiated pharmacological profile, our new long-term safety analyses continue to show a rapid and sustained increase in hemoglobin levels during momelotinib therapy, in contrast to the significant decrease in hemoglobin for patients receiving ruxolitinib. Patients treated with momelotinib also experienced significantly higher mean platelet counts compared to those receiving ruxolitinib. Importantly, patients who switched from ruxolitinib to momelotinib also achieved a sustained improvement in both hemoglobin and platelets," said Prof. Claire Harrison, Guy's and St. Thomas' NHS Foundation Trust, London, United Kingdom. "In addition to an absence of significant rates of high-grade hematological toxicities, long-term tolerability was favorable with no new safety signals or evidence of cumulative toxicity. Notably, this was achieved with most patients receiving full-dose momelotinib."

    "Momelotinib's safety profile and durable anemia benefits facilitated sustained dose intensity across the continuum of JAK inhibitor naïve and previously JAK inhibitor treated myelofibrosis patients. While the starting doses for ruxolitinib were often attenuated due to low platelets, further reductions in dose intensity were also commonly required for ruxolitinib. In contrast, momelotinib was initiated at full dose for all subjects enrolled to the SIMPLIFY studies and high dose intensity was maintained in the majority over extended durations," said Dr. Vikas Gupta, Princess Margaret Cancer Centre, Toronto, Canada. "The ability to safely dose momelotinib sustainably at high dose intensity likely facilitates its ability to durably control the cardinal features of myelofibrosis, namely anemia, constitutional symptoms, and splenomegaly. Furthermore, patients who switch from ruxolitinib to momelotinib saw an immediate and sustained improvement in dose intensity, suggesting a link to the corresponding improvements in hemoglobin and platelets noted by Prof. Harrison. These data suggest that momelotinib may be an optimal therapy in myelofibrosis patients, in particular those experiencing hematological toxicity and disease-related myelosuppression, which are significant unmet needs in this disease."

    The SIMPLIFY-1 trial was conducted in JAKi-naïve myelofibrosis patients (n=432) randomized 1:1 to momelotinib or ruxolitinib for 24 weeks. The SIMPLIFY-2 trial was conducted in prior ruxolitinib-treated myelofibrosis patients with hematological toxicity (n=156) randomized 2:1 to momelotinib or best available therapy (consisting of ruxolitinib in 88% of patients) for 24 weeks. All patients were then subsequently allowed to receive momelotinib for an extended treatment period including those who did not receive momelotinib initially, as they were eligible to cross-over to momelotinib at the end of the 24-week randomized treatment period in both studies.

    About the Posters:

    Please visit www.sierraoncology.com to view Prof. Harrison and Dr. Gupta present the momelotinib Long-Term Safety and Dose Intensity posters. Both e-posters are available through the on-demand EHA Virtual Congress platform at https://ehaweb.org/

    Title: Long term Safety of Momelotinib in JAKi Naïve and Previously JAKi Treated Intermediate/High Risk Myelofibrosis Patients

    Lead Author: Prof. Claire Harrison, Guy's and St. Thomas' NHS Foundation Trust, London, United Kingdom

    Session Title: Myeloproliferative neoplasms - Clinical

    Poster No.: EP1113

    Title: Momelotinib Dose-Intensity is Maintained in JAKi Naïve and Previously JAKi Treated Intermediate/High Risk Myelofibrosis Patients

    Lead Author: Dr. Vikas Gupta, Princess Margaret Cancer Centre, Toronto, ON, Canada

    Session Title: Myeloproliferative neoplasms - Clinical

    Poster No.: EP1103

    About Sierra Oncology

    Sierra Oncology is a late stage drug development company focused on achieving the successful registration and commercialization of momelotinib, a potent, selective and orally-bioavailable JAK1, JAK2 & ACVR1 inhibitor with a targeted mechanism of action that enables it to address all three key drivers of myelofibrosis. Momelotinib's differentiated therapeutic profile encompasses robust constitutional symptom improvements, a range of meaningful anemia benefits, including eliminating or reducing the need for frequent blood transfusions, and comparable spleen control to ruxolitinib. More than 1,200 subjects have received momelotinib since clinical studies began in 2009, including more than 820 patients treated for myelofibrosis.

    Sierra has launched MOMENTUM, a randomized double-blind Phase 3 clinical trial designed to enroll 180 myelofibrosis patients who are symptomatic and anemic, and who have been treated previously with a JAK inhibitor. The U.S. Food and Drug Administration has granted Fast Track designation to momelotinib. Momelotinib is protected by patents anticipated to provide potential exclusivity to 2040 in the United States and Europe (inclusive of potential Patent Term Extension or Supplementary Protection Certificate).

    For more information, please visit www.sierraoncology.com.

    Cautionary Note on Forward-Looking Statements

    This press release contains forward-looking statements within the meaning of the "safe harbor" provisions of the Private Securities Litigation Reform Act of 1995, including, but not limited to, statements regarding Sierra Oncology's expectations from current data, anticipated clinical development activities, and potential benefits of momelotinib. All statements other than statements of historical fact are statements that could be deemed forward-looking statements. These statements are based on management's current expectations and beliefs and are subject to a number of risks, uncertainties and assumptions that could cause actual results to differ materially from those described in the forward-looking statements. Such forward-looking statements are subject to risks and uncertainties, including, among others, the risk that Sierra Oncology's cash resources may be insufficient to fund its current operating plans and it may be unable to raise additional capital when needed, the risk that disruptions and impacts of COVID-19 will be significant and lengthy, Sierra Oncology may be unable to successfully develop and commercialize momelotinib, momelotinib may not demonstrate safety and efficacy or otherwise produce positive results, Sierra Oncology may experience delays in the clinical development of momelotinib, Sierra Oncology may be unable to acquire additional assets to build a pipeline of additional product candidates, Sierra Oncology's third-party manufacturers may cause its supply of materials to become limited or interrupted or fail to be of satisfactory quantity or quality, Sierra Oncology may be unable to obtain and enforce intellectual property protection for its technologies and momelotinib and the other factors described under the heading "Risk Factors" set forth in Sierra Oncology's filings with the Securities and Exchange Commission from time to time. Sierra Oncology undertakes no obligation to update the forward-looking statements contained herein or to reflect events or circumstances occurring after the date hereof, other than as may be required by applicable law.

    Cision View original content:http://www.prnewswire.com/news-releases/sierra-oncology-reports-favorable-long-term-safety-and-dose-intensity-data-for-momelotinib-301074915.html

    SOURCE Sierra Oncology

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  5. - Mr. Craig Collard appointed to the Board of Directors -

    VANCOUVER, May 26, 2020 /PRNewswire/ - Sierra Oncology, Inc. (SRRA), a late-stage drug development company focused on the registration and commercialization of momelotinib, a JAK1, JAK2 & ACVR1 inhibitor with a potentially differentiated therapeutic profile for the treatment of myelofibrosis, today announced the appointment of Dr. Stephen Dilly as President and Chief Executive Officer, effective June 1, 2020. In addition, Dr. Dilly and Mr. Craig Collard have been appointed to the company's Board of Directors.

    "We are delighted to welcome Dr. Dilly to Sierra and look forward to his leadership as we continue to advance momelotinib and start to prepare for its potential commercialization…

    - Mr. Craig Collard appointed to the Board of Directors -

    VANCOUVER, May 26, 2020 /PRNewswire/ - Sierra Oncology, Inc. (SRRA), a late-stage drug development company focused on the registration and commercialization of momelotinib, a JAK1, JAK2 & ACVR1 inhibitor with a potentially differentiated therapeutic profile for the treatment of myelofibrosis, today announced the appointment of Dr. Stephen Dilly as President and Chief Executive Officer, effective June 1, 2020. In addition, Dr. Dilly and Mr. Craig Collard have been appointed to the company's Board of Directors.

    "We are delighted to welcome Dr. Dilly to Sierra and look forward to his leadership as we continue to advance momelotinib and start to prepare for its potential commercialization. Stephen is a proven industry veteran with a track record of success, well-suited to shepherd the company through this evolution. We also welcome Craig Collard, who adds further commercial experience to our Board at this critical stage," said Mr. Robert Pelzer, Chairman of Sierra Oncology. "On behalf of the Board of Directors, I would like to sincerely thank Dr. Nick Glover for his commitment and dedication to Sierra and for guiding the renewed development of momelotinib to this late stage."

    "I am excited to lead Sierra, which has already clearly defined the regulatory path for momelotinib, launched the MOMENTUM Phase 3 trial, and positioned this unique asset as a differentiated treatment that may address unmet needs in myelofibrosis, representing a substantial market opportunity," said Dr. Dilly. "I look forward to working with the Sierra team and Board of Directors to drive this promising investigational therapy forward through its anticipated final phase of clinical development and begin the company's transition into a commercially focused entity."

    Dr. Stephen Dilly brings three decades of executive management experience in the biopharmaceutical industry. Most recently, Dr. Dilly served as CEO and Board Member of Aimmune Therapeutics. Dr. Dilly has served in executive roles at Genentech, Chiron and SmithKline Beecham and has been associated with the development and launch of several marketed drugs. Dr. Dilly also currently serves on the Board of Directors of one public biotechnology company and several private companies. He holds an M.B.B.S. from the University of London and a Ph.D. in Cardiac Physiology from University of London.

    Mr. Craig Collard is currently the CEO of Veloxis Pharmaceutics, Inc., a transplant focused pharmaceutical company, now a subsidiary of Asahi Kasei after its acquisition of Veloxis for $1.3 billion in 2020. Prior to this, he served as the CEO and Chairman of Cornerstone Therapeutics, Inc., a pharmaceutical company he founded in 2004, until February 2014 when the company was purchased by Chiesi Pharmaceuticals, Inc. Before founding Cornerstone, Mr. Collard served as President and CEO of Carolina Pharmaceuticals, Inc., a pharmaceutical company he founded in May 2003. From 1998 to 2003, Mr. Collard served in various commercial roles at Verum Pharmaceuticals, Inc., and DJ Pharma, Inc. Mr. Collard is a member of the Board of Directors of Veloxis, Opiant Pharmaceutics, Inc. and TerrAscend Corporation. Mr. Collard holds a B.S. in Engineering from the Southern College of Technology (now Southern Polytechnic State University) in Marietta, Georgia.

    About Sierra Oncology
    Sierra Oncology is a late stage drug development company focused on achieving the successful registration and commercialization of momelotinib, a potent, selective and orally-bioavailable JAK1, JAK2 & ACVR1 inhibitor with a targeted mechanism of action that enables it to address all three key drivers of myelofibrosis. Momelotinib's differentiated therapeutic profile encompasses robust constitutional symptom improvements, a range of meaningful anemia benefits, including eliminating or reducing the need for frequent blood transfusions, and comparable spleen control to ruxolitinib. More than 1,200 subjects have received momelotinib since clinical studies began in 2009, including more than 820 patients treated for myelofibrosis.

    Sierra has launched MOMENTUM, a randomized double-blind Phase 3 clinical trial designed to enroll 180 myelofibrosis patients who are symptomatic and anemic, and who have been treated previously with a JAK inhibitor. The U.S. Food and Drug Administration has granted Fast Track designation to momelotinib. Momelotinib is protected by patents anticipated to provide potential exclusivity to 2040 in the United States and Europe (inclusive of potential Patent Term Extension or Supplementary Protection Certificate).

    For more information, please visit www.sierraoncology.com.

    Cautionary Note on Forward-Looking Statements
    This press release contains forward-looking statements within the meaning of the "safe harbor" provisions of the Private Securities Litigation Reform Act of 1995, including, but not limited to, statements regarding Sierra Oncology's expectations from current data, anticipated clinical development activities, and potential benefits of momelotinib. All statements other than statements of historical fact are statements that could be deemed forward-looking statements. These statements are based on management's current expectations and beliefs and are subject to a number of risks, uncertainties and assumptions that could cause actual results to differ materially from those described in the forward-looking statements. Such forward-looking statements are subject to risks and uncertainties, including, among others, the risk that Sierra Oncology's cash resources may be insufficient to fund its current operating plans and it may be unable to raise additional capital when needed, the risk that disruptions and impacts of COVID-19 will be significant and lengthy, Sierra Oncology may be unable to successfully develop and commercialize momelotinib, momelotinib may not demonstrate safety and efficacy or otherwise produce positive results, Sierra Oncology may experience delays in the clinical development of momelotinib, Sierra Oncology may be unable to acquire additional assets to build a pipeline of additional product candidates, Sierra Oncology's third-party manufacturers may cause its supply of materials to become limited or interrupted or fail to be of satisfactory quantity or quality, Sierra Oncology may be unable to obtain and enforce intellectual property protection for its technologies and momelotinib and the other factors described under the heading "Risk Factors" set forth in Sierra Oncology's filings with the Securities and Exchange Commission from time to time. Sierra Oncology undertakes no obligation to update the forward-looking statements contained herein or to reflect events or circumstances occurring after the date hereof, other than as may be required by applicable law.

    Cision View original content:http://www.prnewswire.com/news-releases/sierra-oncology-appoints-dr-stephen-dilly-as-president-and-chief-executive-officer-301064895.html

    SOURCE Sierra Oncology

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