UNITED STATES
SECURITIES AND EXCHANGE COMMISSION
Washington, D.C. 20549
FORM 8-K
CURRENT REPORT
Pursuant to Section 13 or 15(d)
of the Securities Exchange Act of 1934
Date of Report (Date of earliest event reported): August 3, 2021
SIERRA ONCOLOGY, INC.
(Exact name of registrant as specified in its charter)
Delaware | 001- 37490 | 20-0138994 | ||
(State or other jurisdiction of incorporation) |
(Commission File Number) |
(IRS Employer Identification No.) |
1820 Gateway Drive, San Mateo, California |
94404 | |
(Address of principal executive offices) | (Zip Code) |
(650) 376-8679
(Registrants telephone number, including area code)
N/A
(Former name or former address, if changed since last report)
Check the appropriate box below if the Form 8-K filing is intended to simultaneously satisfy the filing obligation of the registrant under any of the following provisions (see General Instruction A.2. below):
☐ Written communications pursuant to Rule 425 under the Securities Act (17 CFR 230.425)
☐ Soliciting material pursuant to Rule 14a-12 under the Exchange Act (17 CFR 240.14a-12)
☐ Pre-commencement communications pursuant to Rule 14d-2(b) under the Exchange Act (17 CFR 240.14d-2(b))
☐ Pre-commencement communications pursuant to Rule 13e-4(c) under the Exchange Act (17 CFR 240.13e-4(c))
Securities registered pursuant to Section 12(b) of the Act:
Title of each class |
Trading Symbol(s) |
Name of each exchange on which registered | ||
Common Stock, $0.001 par value | SRRA | The Nasdaq Global Market |
Indicate by check mark whether the registrant is an emerging growth company as defined in Rule 405 of the Securities Act of 1933 (§230.405 of this chapter) or Rule 12b-2 of the Securities Exchange Act of 1934 (§240.12b-2 of this chapter).
Emerging growth company ☐
If an emerging growth company, indicate by check mark if the registrant has elected not to use the extended transition period for complying with any new or revised financial accounting standards provided pursuant to Section 13(a) of the Exchange Act. ☐
ITEM 1.01. | ENTRY INTO A MATERIAL DEFINITIVE AGREEMENT. |
On August 3, 2021, Sierra Oncology (the Company) entered into a License Agreement (the License Agreement) with AstraZeneca AB (AstraZeneca). Under the License Agreement, AstraZeneca provides the Company with a worldwide license for AZD5153 and related compounds, which selectively inhibit bromodomain-containing protein 4 (BRD4). Under the License Agreement, the Company will have an exclusive license to develop, manufacture and commercialize AZD5153. The License Agreement provides that the Company will make a one-time, non-refundable upfront cash payment of $8 million to AstraZeneca. In addition, the Company has agreed to pay AstraZeneca up to $208.0 million upon the achievement of certain development, regulatory and commercial milestones, and a tiered royalty on worldwide net sales ranging from high single-digits to low double-digits.
The foregoing is a summary of the terms of the License Agreement and is qualified in its entirety by reference to the License Agreement, a copy of which will be filed as an exhibit to an exhibit to the Companys Quarterly Report on Form 10-Q for the period ended September 30, 2021.
ITEM 8.01. | OTHER EVENTS. |
On August 5, 2021, the Company issued a press release announcing the License Agreement with AstraZeneca. A copy of the Companys press release is attached hereto as exhibit 99.1.
Item 9.01 | FINANCIAL STATEMENTS AND EXHIBITS. |
(d) Exhibits.
Exhibit No. | Description | |
99.1 | Press Release, dated August 5, 2021. |
SIGNATURES
Pursuant to the requirements of the Securities Exchange Act of 1934, the registrant has duly caused this report to be signed on its behalf by the undersigned hereunto duly authorized.
SIERRA ONCOLOGY, INC. | ||
By: | /s/ Christina Thomson | |
Christina Thomson | ||
General Counsel and Corporate Secretary |
Date: August 5, 2021
Exhibit 99.1
Sierra Oncology Signs Exclusive Global In-Licensing Agreement with AstraZeneca for
Novel BET Inhibitor to Expand Myelofibrosis Pipeline
Combination study to build upon momelotinibs differentiated potential as a cornerstone myelofibrosis therapy-
SAN MATEO, CA, August 5, 2021 - Sierra Oncology, Inc. (NASDAQ: SRRA), a late-stage biopharmaceutical company on a mission to deliver targeted therapies that treat rare forms of cancer, today announced it has acquired an exclusive global license from AstraZeneca (LSE/STO/NASDAQ: AZN) for AZD5153, a potent and selective BRD4 BET inhibitor with a novel bivalent binding mode. Sierra plans to initiate a Phase 2 study examining momelotinib in combination with AZD5153 in myelofibrosis patients in the first half of 2022.
This global in-licensing deal is of two-fold importance to Sierras long-term strategy. First, it brings another novel compound into the Sierra development pipeline, expanding our opportunity to deliver transformative therapies for patients with rare cancers. Second, it may allow us to enhance and extend our ability to treat myelofibrosis patients, building on momelotinibs potential as a cornerstone therapy, said Stephen Dilly, MBBS, PhD, President and Chief Executive Officer at Sierra Oncology.
Inhibitors of the Bromodomain and Extra-terminal Domain (BET protein family consisting of BRD2, BRD3, BRD4 and BRDT) can modify a range of pathological cellular processes, including the initiation and continuation of transcription and cell cycle control. BET inhibition can lead to decreased inflammatory cytokine release, anti-fibrotic activity and reduced mutant cell proliferation, all of which are indicative of disease-modifying effects. Several BET inhibitors are under clinical investigation in multiple solid tumor and hematologic indications, including myelofibrosis.
AZD5153 is a selective BRD4 inhibitor with a novel bivalent binding mode that inhibits both protein bromodomains, resulting in improved potency. Unlike currently available JAK inhibitors, momelotinib is not myelosuppressive, therefore the combination of momelotinib and AZD5153 may provide an efficacy and safety advantage over other JAK inhibitor plus BET inhibitor combinations and allow for prolonged dose intensity and treatment duration. This trial will be designed to provide preliminary proof of concept for a future confirmatory study and support potential additional studies of momelotinib with other novel agents in development for myelofibrosis. Trial initiation is anticipated to begin in the first half of 2022.
Mark Kowalski, MD, PhD, Chief, Research and Early Development at Sierra added, The combination of JAK inhibition and BET inhibition has been identified as a promising emergent approach for the treatment of myelofibrosis. However, currently available JAK inhibitors are myelosuppressive, leaving a critical unmet need for patients with anemia or those at risk of developing treatment-emergent anemia. Given momelotinibs unique mechanism as an inhibitor of ACVR1 / ALK2 in addition to JAK1 and JAK2, we are excited by the potential for improved outcomes for myelofibrosis patients with this promising combination.
Deal Terms
Under the terms of the agreement, Sierra will pay AstraZeneca an upfront payment, as well as certain pre-determined development, regulatory and commercial milestones. In addition, Sierra will provide tiered royalty payments based on future commercial success. Sierra will be responsible for the initial Phase 2 trial execution and all future global development and commercialization activities. Additional deal terms will be included on a Form 8-K filed with the SEC.
Conference Call & Webcast
In connection with this announcement, Sierra will host a conference call and webcast on Thursday, August 5, 2021, at 5:00 pm ET. The call may be accessed by calling (844) 200-6205 (Toll-free in North America) or +44 208 0682 558 (International Dial-in) and entering the Conference ID number: 956684. The call will be webcast live and will be accessible through the Investor section of the Companys website at www.SierraOncology.com. An archived replay of the webcast will be made available at the same location.
About Momelotinib
Momelotinib is a selective and orally bioavailable JAK1, JAK2 and ACVR1 / ALK2 inhibitor for the potential treatment of myelofibrosis. Myelofibrosis results from dysregulated JAK-STAT signaling and is characterized by constitutional symptoms, splenomegaly (enlarged spleen) and progressive anemia.
Momelotinib is currently under investigation in the MOMENTUM clinical trial, a global, randomized, double-blind Phase 3 study for symptomatic and anemic myelofibrosis patients. Top-line data are anticipated in Q1 2022. The U.S. Food & Drug Administration has granted Fast Track designation for momelotinib.
About Sierra Oncology
Sierra Oncology is a late-stage biopharmaceutical company on a mission to deliver targeted therapies that treat rare forms of cancer. We harness our deep scientific expertise to identify compounds that target the root cause of disease to advance targeted therapies with assets on the leading edge of cancer biology. Our team takes an evidence-based approach to understand the limitations of current treatments and explore new ways to change the cancer treatment paradigm. Together we are transforming promise into patient impact.
For more information, 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 Oncologys expectations regarding the commercialization and future success of momelotinib and future expansion of its pipeline, the potential of AZD5153 including its impact on Sierra Oncologys ability to treat myelofibrosis patients and its potential safety and efficacy advantages when combined with momelotinib, the timing of Sierra Oncologys initiation of a Phase 2 study examining momelotinib in connection with AZD5153, including the timing of enrollment and the expected timing for top-line data in the MOMENTUM clinical trial. All statements other than statements of historical fact are statements that could be deemed forward-looking statements. These statements are based on managements 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 may not be able to successfully develop, obtain regulatory approval for and commercialize momelotinib or experience significant delays in doing so, Sierra Oncology may not be able to demonstrate acceptable safety and efficacy of momelotinib and momelotinib in combination with AZD5153, the risk that disruptions and impacts of COVID-19 will be significant and lengthy, Sierra Oncologys cash resources may be insufficient to fund its current operating plans and it may be unable to raise additional capital when needed, Sierra Oncology may be unable to acquire additional assets to build a pipeline of additional product candidates, Sierra Oncologys 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 Oncologys 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.
For Further Information:
Investor Contact
DeDe Sheel
415.732.9828
dsheel@sierraoncology.com
Media Contact
Lauren Musto
615.351.7777
lmusto@sierraoncology.com
SOURCE: Sierra Oncology