0001193805-21-001525.txt : 20211103 0001193805-21-001525.hdr.sgml : 20211103 20211103160132 ACCESSION NUMBER: 0001193805-21-001525 CONFORMED SUBMISSION TYPE: 8-K PUBLIC DOCUMENT COUNT: 14 CONFORMED PERIOD OF REPORT: 20211103 ITEM INFORMATION: Departure of Directors or Certain Officers; Election of Directors; Appointment of Certain Officers: Compensatory Arrangements of Certain Officers ITEM INFORMATION: Other Events ITEM INFORMATION: Financial Statements and Exhibits FILED AS OF DATE: 20211103 DATE AS OF CHANGE: 20211103 FILER: COMPANY DATA: COMPANY CONFORMED NAME: Summit Therapeutics Inc. CENTRAL INDEX KEY: 0001599298 STANDARD INDUSTRIAL CLASSIFICATION: PHARMACEUTICAL PREPARATIONS [2834] IRS NUMBER: 000000000 STATE OF INCORPORATION: DE FISCAL YEAR END: 1231 FILING VALUES: FORM TYPE: 8-K SEC ACT: 1934 Act SEC FILE NUMBER: 001-36866 FILM NUMBER: 211375238 BUSINESS ADDRESS: STREET 1: ONE BROADWAY STREET 2: 14TH FLOOR CITY: CAMBRIDGE STATE: MA ZIP: 02142 BUSINESS PHONE: 617-514-7149 MAIL ADDRESS: STREET 1: ONE BROADWAY STREET 2: 14TH FLOOR CITY: CAMBRIDGE STATE: MA ZIP: 02142 FORMER COMPANY: FORMER CONFORMED NAME: Summit Therapeutics plc DATE OF NAME CHANGE: 20150219 FORMER COMPANY: FORMER CONFORMED NAME: Summit Corp plc DATE OF NAME CHANGE: 20140205 8-K 1 e621052_8k-summit.htm

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): November 3, 2021

Summit Therapeutics Inc.
(Exact Name of Registrant as Specified in Its Charter)

Delaware	001-36866	37-1979717
(State or Other Jurisdiction of Incorporation)	(Commission File Number)	(IRS Employer Identification No.)

One Broadway, 14th Floor, Cambridge, MA		02142
(Address of Principal Executive Offices)		(Zip Code)

Registrant’s Telephone Number, Including Area Code: 617-514-7149

Not Applicable

(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, $0.01 par value per share	SMMT	The Nasdaq Stock Market LLC

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 5.02

Departure of Directors or Certain Officers; Election of Directors; Appointment of Certain Officers; Compensatory Arrangements of Certain Officers.

Effective on November 3, 2021, the board of directors (the “Board”) of Summit Therapeutics Inc. (the “Company”) unanimously approved (i) the election of Urte Gayko as a director of the Company, to occupy a newly created seat on the Board and (ii) the appointment of Dr. Gayko to serve on the Nominating and Corporate Governance Committee. Upon her appointment as a director, Dr. Gayko received a grant of certain options to purchase shares of the Company’s common stock in accordance with the Company’s existing non-employee director compensation policies. In addition, in accordance with such policies, Dr. Gayko will be entitled to an annual grant of options, a retainer and fees for committee service. The Company and Dr. Gayko have also entered into the Company’s standard form of indemnification agreement for the Company’s directors and officers.

Dr. Gayko is the Senior Vice President of Drug Development and Regulatory Affairs at Nektar Therapeutics. Prior to joining Nektar in 2020, Dr. Gayko was at Pharmacyclics, Inc. from 2012 to 2020, where she served in multiple leadership roles, including Global Head of Regulatory Affairs and Pharmacovigilance. She has also previously held roles at Nodality Inc. from 2008 to 2012, a biotech start-up and at Amgen from 1999 to 2008 where she worked in regulatory and clinical development on several oncology therapeutics and supportive care products. Dr. Gayko performed her Ph.D. research in Molecular and Cellular Biology at Harvard University. The Board has determined that Dr. Gayko qualifies as an independent director under applicable Nasdaq listing rules.

Item 8.01

Other Events.

On November 3, 2021, the Company issued a press release announcing the election of Dr. Gayko to the Board. A copy of the press release is attached as Exhibit 99.1 to this Current Report on Form 8-K and is incorporated by reference herein.

Item 9.01

Financial Statements and Exhibits.

(d) Exhibits

Exhibit Number	Description

99.1	Press Release, dated November 3, 2021.
104	Cover Page Interactive Data File (formatted as Inline XBRL and contained in the Inline XBRL document)

SIGNATURE

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, thereunto duly authorized.

	SUMMIT THERAPEUTICS INC.


Date: November 3, 2021	By:	/s/ Robert W. Duggan
		Robert W. Duggan
		Chairman and Chief Executive Officer

EX-99.1 2 e621052_ex99-1.htm

Summit Therapeutics Bolsters Its Board of Directors with

Seasoned Regulatory & Clinical Research Executive Dr. Urte Gayko

Cambridge, Massachusetts – Summit Therapeutics Inc. (NASDAQ: SMMT) today announced that Dr. Urte Gayko, PhD, has been appointed to our Board of Directors, effective immediately. Dr. Gayko is currently the Senior Vice President of Drug Development & Regulatory Affairs at Nektar Therapeutics.

Dr. Gayko previously served as the Global Head of Regulatory Affairs and Pharmacovigilance at Pharmacyclics, Inc., and has over 20 years of experience in areas encompassing regulatory and clinical development ranging from pre-commercial entities to large biopharmaceutical companies, including Amgen and AbbVie. Dr. Gayko performed her PhD research in molecular and cellular biology at Harvard University.

“As we continue to mature and build a viable, long-lasting organization poised to fulfill our mission, Urte’s regulatory and clinical savvy and experience will provide key counsel to Team Summit and our world-class executives,” said Robert W. Duggan, Chairman and Chief Executive Officer of Summit. “As we continue to develop our pipeline molecules, contemplate adding new drugs to our pipeline, and look towards commercializing these important medicinal therapies, adding Urte strengthens our already impressive Board as we take the next step in our journey to make a meaningful impact on the health and lives of patients facing serious unmet medical needs.”

“Having worked with Urte previously and benefiting from her incredible expertise in navigating regulatory approvals across the largest agencies in the world, Bob and I are honored to add Urte as a member of our Board,” added Dr. Maky Zanganeh, Chief Operating Officer and a member of Summit’s Board of Directors. “We continue to progress ridinilazole’s clinical development, and we are seeking to expand our pipeline product portfolio into additional therapeutic areas that target the cause or effect of the disease, while sparing the rest of the human body, and minimizing the trauma experienced by patients. Urte’s level-handed experience in working through the complex process of successfully developing a drug and coordinating with regulatory agencies, ultimately seeking their approval for commercialization, will provide incredible value in our journey.”

“Summit emphasizes taking full responsibility for its mission to design, develop, gain approval and commercialize its medicinal therapies in order to meaningfully improve the quality and potential duration of patients’ lives. This mindset and focus across the full drug development process, I believe, are critical to breaking through and making a meaningful impact on the health care ecosystem,” stated Dr. Gayko. “Few things are more rewarding in life than seeing beneficial impacts of the work of bringing a drug through the clinical development and regulatory approval process in such a manner that changes the lives of the patients who needed the medicinal therapy most. I am excited to get the opportunity to work alongside Bob and Maky again and help Team Summit build the organization into a leader in improving the lives of patients with serious unmet medical needs.”

About Summit Therapeutics

The overriding objective of Summit Therapeutics is to create value for patients, hospital caregivers, and community-based healthcare providers, as well as healthcare payers around the world. We seek to create value by developing drugs with high therapeutic efficacy - curing the cause of the patient's condition with minimal or zero disease recurrence or antimicrobial resistance, for the longest extent possible - and minimizing the trauma caused to the patient and healthcare ecosystem by minimizing serious side effects, disease recurrence, and inaccessibility to our treatments as a result of financial or other barriers. Summit Therapeutics, empowered by its Discuva Platform, the Company’s innovative antibiotic discovery engine, and supported by BARDA and CARB-X funding, intends to be the leader in patient-friendly and paradigm-shifting treatments for infectious diseases and other significant unmet medical needs while being an ally to physicians. Our new mechanism pipeline product candidates are designed with the goal to become the patient-friendly, new-era standard of care, by working in harmony with the human microbiome to treat prospective patients suffering from infectious diseases, initially focusing on Clostridioides difficile infection (CDI). Currently, Summit’s lead product candidate, ridinilazole, is a novel, first-in-class drug engaged in a global Phase III trial program versus vancomycin, for use as first-line therapy for the treatment of initial and recurrent Clostridioides difficile infection, and to show superiority in sustained clinical response. Commercialization of ridinilazole is subject to regulatory approvals. SMT-738, the second candidate within Summit’s portfolio, is currently in the IND-enabling phase for the treatment of multidrug resistant infections, specifically those caused by carbapenem-resistant Enterobacteriaceae (CRE).

For more information, please visit https://www.summittxinc.com and follow us on Twitter @summitplc. For more information on the Company’s Discuva Platform, please visit https://www.summittxinc.com/our-science/discuva-platform.

Contact Summit Investor Relations

Dave Gancarz

Head of Investor Relations & Corporate Strategy

david.gancarz@summitplc.com

General Inquiries:

investors@summitplc.com

Summit Forward-looking Statements

Any statements in this press release about the Company’s future expectations, plans and prospects, including but not limited to, statements about the clinical and preclinical development of the Company’s product candidates, the therapeutic potential of the Company’s product candidates, the potential commercialization of the Company’s product candidates, the timing of initiation, completion and availability of data from clinical trials, the potential submission of applications for marketing approvals, the impact of the COVID-19 pandemic on the Company’s operations and clinical trials and other statements containing the words "anticipate," "believe," "continue," "could," "estimate," "expect," "intend," "may," "plan," "potential," "predict," "project," "should," "target," "would," and similar expressions, constitute forward-looking statements within the meaning of The Private Securities Litigation Reform Act of 1995. Actual results may differ materially from those indicated by such forward-looking statements as a result of various important factors, including: the uncertainties inherent in the initiation of future clinical trials, availability and timing of data from ongoing and future clinical trials and the results of such trials, global public health crises, including the coronavirus COVID-19 outbreak, that may affect timing and status of our clinical trials and operations, whether preliminary results from a clinical trial will be predictive of the final results of that trial or whether results of early clinical trials or preclinical studies will be indicative of the results of later clinical trials, expectations for regulatory approvals, laws and regulations affecting government contracts and funding awards, availability of funding sufficient for the Company’s foreseeable and unforeseeable operating expenses and capital expenditure requirements and other factors discussed in the "Risk Factors" section of filings that the Company makes with the Securities and Exchange Commission. Any change to our ongoing trials could cause delays, affect our future expenses, and add uncertainty to our commercialization efforts, as well as to affect the likelihood of the successful completion of clinical development of ridinilazole. Accordingly, readers should not place undue reliance on forward-looking statements or information. In addition, any forward-looking statements included in this press release represent the Company’s views only as of the date of this release and should not be relied upon as representing the Company’s views as of any subsequent date. The Company specifically disclaims any obligation to update any forward-looking statements included in this press release.

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DE 001-36866 37-1979717 One Broadway, 14th Floor Cambridge MA 02142 617 514-7149 Not Applicable false false false false Common stock, $0.01 par value per share SMMT NASDAQ false XML 8 R1.htm IDEA: XBRL DOCUMENT

Cover	Nov. 03, 2021
Cover [Abstract]
Document Type	8-K
Amendment Flag	false
Document Period End Date	Nov. 03, 2021
Entity File Number	001-36866
Entity Registrant Name	Summit Therapeutics Inc.
Entity Central Index Key	0001599298
Entity Tax Identification Number	37-1979717
Entity Incorporation, State or Country Code	DE
Entity Address, Address Line One	One Broadway, 14th Floor
Entity Address, City or Town	Cambridge
Entity Address, State or Province	MA
Entity Address, Postal Zip Code	02142
City Area Code	617
Local Phone Number	514-7149
Written Communications	false
Soliciting Material	false
Pre-commencement Tender Offer	false
Pre-commencement Issuer Tender Offer	false
Title of 12(b) Security	Common stock, $0.01 par value per share
Trading Symbol	SMMT
Security Exchange Name	NASDAQ
Entity Emerging Growth Company	false
Entity Information, Former Legal or Registered Name	Not Applicable

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