UNITED STATES
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FORM
CURRENT REPORT
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| Item 5.02 | Departure of Directors or Certain Officers; Election of Directors; Appointment of Certain Officers; Compensatory Arrangements of Certain Officers. |
Departure of Chief Medical Officer
On September 12, 2024, Mark Bach, M.D., Ph.D. entered into a separation and consulting agreement (the “Bach Separation and Consulting Agreement”) with Structure Therapeutics Inc. (the “Company”) in connection with his departure as Chief Medical Officer (“CMO”) as part of a planned succession, effective as of September 18, 2024 (the “Effective Date”). Following the Effective Date, Dr. Bach will remain as an employee of the Company until September 23, 2024 (the “Separation Date”). To ensure an orderly transition, Dr. Bach has agreed to serve in an advisory capacity to the Company through December 31, 2024, which period may be further extended with the mutual written agreement of Dr. Bach and the Company (the “Advisory Period”).
Pursuant to the Bach Separation and Consulting Agreement, Dr. Bach will be entitled to receive, subject to Dr. Bach’s timely execution of a customary release of claims in favor of the Company and compliance with his obligations under the Bach Separation and Consulting Agreement: (a) a lump sum amount equal to nine months of his then-current annual base salary; (b) COBRA group health insurance continuation ending nine months after the Separation Date; and (c) acceleration of vesting of unvested time-based equity awards as if he had provided an additional six months of continued services following the Separation Date. As compensation for advisory services performed under the Bach Separation and Consulting Agreement, Dr. Bach will be eligible to receive (i) advisory fees at a rate of $16,000 per month provided he spends up to thirty-two hours per month providing advisory services during the Advisory Period; and (ii) a lump sum amount to be determined by the Company at the end of the Advisory Period, based upon the Company’s achievement of certain corporate goals during fiscal year 2024.
The foregoing description of the Bach Separation and Consulting Agreement is not complete and is subject to and qualified in its entirety by reference to the complete text of the Bach Separation and Consulting Agreement, a copy of which the Company intends to file with the Securities and Exchange Commission as an exhibit to the Company’s Quarterly Report on Form 10-Q for the quarterly period ending September 30, 2024.
| Item 7.01 | Regulation FD Disclosure. |
On September 17, 2024, the Company issued a press release announcing Dr. Bach’s departure and Dr. Coll’s and Ms. Hall’s appointments. The press release is furnished as Exhibit 99.1 to this Current Report on Form 8-K and incorporated herein by reference.
The information set forth in this Item 7.01 and in the press release attached hereto as Exhibit 99.1, is deemed to be “furnished” and shall not be deemed to be “filed” for purposes of Section 18 of the Securities Exchange Act of 1934, as amended (the “Exchange Act”), or otherwise subject to the liabilities of that Section. The information set forth in this Item 7.01, including Exhibit 99.1, shall not be deemed incorporated by reference into any filing under the Exchange Act or the Securities Act of 1933, as amended, except to the extent that the Company specifically incorporates it by reference.
| Item 8.01 | Other Events. |
Appointment of Chief Medical Officer
On September 17, 2024, the Company announced the appointment of Blai Coll, M.D., Ph.D., as the Company’s CMO as part of the planned succession replacing Dr. Bach, effective as of the Effective Date.
Dr. Coll, 51, most recently served as the Company’s Vice President of Endocrine and Metabolism Clinical Development beginning in May 2022. Prior to joining the Company, Dr. Coll served in various roles at Amgen Inc. (“Amgen”) from August 2016 to May 2022, including as Cardiovascular and Metabolic Platform Lead, Medical Affairs from June 2020 to May 2022, and Medical Lead for Repatha® from November 2018 to June 2020, leading lifecyle management of Repatha including late-stage clinical studies and extension studies in more than 6,000 patients. Before joining Amgen, Dr. Coll served as Medical Director at AbbVie Inc., leading the late-stage atrasentan clinical program for chronic kidney disease, including a Phase 3 multinational outcomes study. Dr. Coll earned his medical degree from Universitat Autonoma de Barcelona School of Medicine and a Ph.D. from Universitat Rovira i Virgili.
Appointment of Chief Development Officer
On September 17, 2024, the Company announced the appointment of Ashley Hall, J.D., as the Company’s Chief Development Officer, effective as of the Effective Date.
Ms. Hall, 52, most recently served as Chief Development Officer of Reneo Pharmaceuticals beginning in October 2021. Prior to joining Reneo Pharmaceuticals, Ms. Hall was the Chief Development Officer of Esperion Therapeutics, Inc., a public pharmaceutical company, from August 2019 to August 2021. Prior to that, she served as Esperion’s Senior Vice President of Global Regulatory Affairs and Policy from January 2018 to August 2019 and as its Vice President of Global Regulatory Affairs and Policy from August 2015 to January 2018. In those roles, she was responsible for the conduct of five pivotal low density lipoprotein cholesterol (LDL-C) lowering trials in over 4,000 patients and a large cardiovascular outcomes trial (CVOT). Ms. Hall was previously at Amgen, where she led the global regulatory strategy and marketing applications for Repatha in 11 countries and regions, including the United States, Japan and the European Union. Prior to Amgen, Ms. Hall served as the Vice President of Regulatory Affairs at Micromet, Inc. (acquired by Amgen), and held prior leadership roles at RevoGenex Inc., MedImmune, LLC (acquired by AstraZeneca), and Abraxis BioScience. Ms. Hall earned a Juris Doctorate at the University of San Diego, School of Law and a Bachelor of Science in Biochemistry and Cell Biology at the University of California San Diego.
| Item 9.01 | Financial Statements and Exhibits. |
(d) Exhibits.
| Exhibit | ||
| No. | Description | |
| 99.1 | Press Release dated September 17, 2024 | |
| 104 | Cover Page Interactive Data File (embedded within the Inline XBRL document) |
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.
| Structure Therapeutics Inc. | ||
| Date: September 17, 2024 | By: | /s/ Raymond Stevens |
| Raymond Stevens, Ph.D. | ||
| Chief Executive Officer | ||
Exhibit 99.1
Structure Therapeutics Strengthens Executive Team with
Promotion of Blai Coll, M.D., Ph.D. to Chief Medical Officer and Appointment of Ashley Hall, J.D. as Chief Development Officer
SAN FRANCISCO – September 17, 2024 – Structure Therapeutics Inc. (NASDAQ: GPCR), a clinical-stage global biopharmaceutical company developing novel oral small molecule therapeutics for metabolic and cardiopulmonary diseases, today announced key leadership appointments to drive its next phase of development and operational success. Blai Coll, M.D., Ph.D., has been promoted to Chief Medical Officer, replacing Mark Bach, M.D., Ph.D. as part of a planned succession, effective September 18. Dr. Coll has served as Vice President of Clinical Development at Structure since 2022, leading the GSBR-1290 program, Structure’s oral small molecule GLP-1 agonist that is planned to enter Phase 2b clinical development for obesity in the fourth quarter of 2024. In addition, Ashley Hall, J.D., has been appointed to the newly created position of Chief Development Officer, and will be responsible for clinical development operations, project management, regulatory affairs and quality assurance.
“Our expanded clinical leadership team strengthens our position to efficiently execute as we move into Phase 2b development of GSBR-1290 in the fourth quarter. In addition, we are building our organization to advance our promising oral amylin compound into the clinic as soon as possible,” said Raymond Stevens, Ph.D., Founder and CEO of Structure Therapeutics. “Ms. Hall’s unique background in regulatory strategy and clinical development operations will help enable us to rapidly develop our oral small molecules for patients with cardiometabolic diseases. Dr. Coll has a deep understanding of the cardiometabolic clinical space and in his time at Structure, he has led the rapid advancement of GSBR-1290. I would like to thank Dr. Bach for his contributions over the last few years in establishing the foundation for our clinical organization and working closely with Dr. Coll as part of this planned transition.”
About Blai Coll, M.D., Ph.D.
Dr. Coll is a physician-scientist with 15 years of experience in clinical development. Prior to being promoted to Chief Medical Officer, Dr. Coll was Vice President of Endocrine and Metabolism Clinical Development at Structure Therapeutics, where he led the company’s clinical development activities for GSBR-1290. Before joining Structure, Dr. Coll was at Amgen where he held different leadership positions in the cardiovascular group, including management of lifecycle studies for Repatha® (open label extension studies with more than 6,000 patients) and early development projects in the cardiovascular space. Before joining Amgen, Dr. Coll served as Medical Director at AbbVie, leading the late-stage atrasentan clinical program for chronic kidney disease, including a Phase 3 multinational outcomes study.
About Ashley Hall, J.D.
Ms. Hall has extensive experience in global clinical development operations and regulatory affairs at several companies, particularly in the development of Repatha®, Nexletol®, and Nexlizet®, three therapies approved for the management of hyperlipidemia and cardiovascular risk reduction. Over the last 23 years, Ms. Hall has collaborated closely with global regulatory authorities to navigate complex development and operational processes for multiple successful large-scale, multi-national Phase 3 clinical trials. Prior to joining Structure Therapeutics, Ms. Hall served as Chief Development Officer of Reneo Pharmaceuticals. Prior to Reneo, Ms. Hall was the Chief Development Officer and Head of Global Regulatory Affairs at Esperion Therapeutics, where she was responsible for the conduct of five pivotal trials in low density lipoprotein cholesterol (LDL-C) lowering in over 4,000 patients and a large cardiovascular outcomes trial (CVOT). Ms. Hall was previously at Amgen, where she led the global regulatory strategy and marketing applications for Repatha® in 11 countries and regions, including the United States, Japan and the European Union.
About Structure Therapeutics
Structure Therapeutics is a science-driven clinical-stage biopharmaceutical company focused on discovering and developing innovative oral small molecule treatments for chronic metabolic and cardiopulmonary conditions with significant unmet medical needs. Utilizing its next generation structure-based drug discovery platform, the Company has established a robust GPCR-targeted pipeline, featuring multiple wholly-owned proprietary clinical-stage small molecule compounds designed to surpass the scalability limitations of traditional biologic and peptide therapies and be accessible to more patients around the world. For additional information, please visit www.structuretx.com.
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. All statements other than statements of historical fact are statements that could be deemed forward-looking statements, including, without limitation, statements concerning: the Company’s future plans and prospects; and the timing of the Company’s clinical development programs. In addition, when or if used in this press release, the words and phrases “expect,” “plan,” “potential,” “promising,” “to be,” and similar expressions and their variants, as they relate to the Company may identify forward-looking statements. Forward-looking statements are neither historical facts nor assurances of future performance. Although the Company believes the expectations reflected in such forward-looking statements are reasonable, the Company can give no assurance that such expectations will prove to be correct. Readers are cautioned that actual results, levels of activity, safety, performance or events and circumstances could differ materially from those expressed or implied in the Company’s forward-looking statements due to a variety of risks and uncertainties, which include, without limitation, risks and uncertainties related to the Company’s ability to advance GSBR-1290, LTSE-2578, ANPA-0073 and its other therapeutic candidates, obtain regulatory approval of and ultimately commercialize the Company’s therapeutic candidates, competitive products or approaches limiting the commercial value of the Company’s product candidates, the timing and results of preclinical and clinical trials, the Company’s ability to fund development activities and achieve development goals, the impact of any global pandemics, inflation, supply chain issues, rising interest rates and future bank failures on the Company’s business, its ability to protect its intellectual property and other risks and uncertainties described in the Company’s filings with the Securities and Exchange Commission (SEC), including the Company’s Annual Report on Form 10-K for the year ended December 31, 2023, as filed with the SEC on March 8, 2024, the Quarterly Report on Form 10-Q filed with the SEC on August 8, 2024, and future reports the Company may file with the SEC from time to time. All forward-looking statements contained in this press release speak only as of the date on which they were made and are based on management’s assumptions and estimates as of such date. The Company undertakes no obligation to update such statements to reflect events that occur or circumstances that exist after the date on which they were made, except as required by law.
Investors:
Danielle Keatley
Structure Therapeutics Inc.
ir@structuretx.com
Media:
Dan Budwick
1AB
Dan@1abmedia.com