smmt-20220811

SECURITIES AND EXCHANGE COMMISSION

Washington, D.C. 20549

Pursuant to Section 13 or 15(d) of The Securities Exchange Act of 1934

Date of Report (Date of Earliest Event Reported): August 11, 2022


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.)

2882 Sand Hill Road, Suite 106, Menlo Park, CA		94025
(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 2.02			Results of Operations and Financial Condition.

On August 11, 2022, Summit Therapeutics Inc. (the "Company") announced its financial results and operational progress for the second quarter ended June 30, 2022. A copy of the press release is being furnished as Exhibit 99.1 to this Current Report on Form 8-K and is incorporated herein by reference.

The information in this Item 2.02 of this Current Report on Form 8-K and Exhibit 99.1 attached hereto is intended to be furnished and shall not be deemed “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, nor shall it be deemed incorporated by reference in any filing under the Securities Act of 1933, as amended, or the Exchange Act, except as expressly set forth by specific reference in such filing.


Item 9.01			Financial Statements and Exhibits.


Exhibit Number			Description
99.1			Press release, dated August 11 , 2022
104			Cover Page Interactive Data File (embedded within the Inline XBRL document)

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.


	SUMMIT THERAPEUTICS INC.


Date: August 11, 2022	By:	/s/ Ankur Dhingra
		Chief Financial Officer
		(Principal Financial Officer)

Summit Therapeutics Inc Reports Financial Results and Operational Progress

for the Second Quarter Ended June 30, 2022

Menlo Park, California, August 11, 2022 - Summit Therapeutics Inc. (NASDAQ: SMMT) ("Summit," "we," or the "Company") today reports its financial results and provides an update on operational progress for the second quarter ended June 30, 2022.

Financial Highlights

•Aggregate cash, accounts receivable, and tax credits receivable on June 30, 2022 totaled $74.0 million as compared to $89.0 million on December 31, 2021. Our cash balance on June 30, 2022 was $57.3 million as compared to $71.8 million on December 31, 2021. Accounts receivable and research and development tax credits receivable on June 30, 2022 were $16.7 million as compared to $17.2 million on December 31, 2021.

•Net loss for the three months ended June 30, 2022 and 2021 was $16.8 million and $24.4 million, respectively. Net loss for the six months ended June 30, 2022 and 2021 was $38.2 million and $41.9 million, respectively.

•Operating cash outflow for the six months ended June 30, 2022 and 2021 was $38.2 million and $39.8 million, respectively.

•On June 22, 2022, the Company announced a Rights Offering for its existing shareholders to participate in the purchase of additional shares of its common stock. The Rights Offering commenced on July 18, 2022, and the associated subscription rights expired on August 8, 2022. Through the fully subscribed Rights Offering, the Company raised $100.0 million in gross proceeds through the issuance and sale of approximately 103 million shares of its common stock at a price per share of $0.97. Issuance costs associated with the Rights Offering were approximately $0.1 million, resulting in net proceeds of approximately $99.9 million.

◦In connection with the closing of the rights offering, a $25.0 million note payable with the Company's Chairman and CEO, Robert W. Duggan, matured and became due, and the Company repaid all principal and accrued interest via a portion of the proceeds from this Rights Offering.

•During the three months ended June 30, 2022, the Company received non-dilutive funding of $0.1 million from the Biomedical Advanced Research and Development Authority ("BARDA"), part of the Office of the Assistant Secretary for Preparedness and Response at the U.S. Department of Health and Human Services, in support of the Company's Ri-CoDIFy clinical trials and clinical development of ridinilazole. As of June 30, 2022, an aggregate of $58.0 million out of a potential award of $72.5 million has been received from BARDA under contract number HHSO100201700014C. The contract with BARDA was set to expire on April 30, 2022. The contract was extended through December 2022 as a no cost contract, solely to close out open activities. Remaining potential funding from BARDA has not been included in aggregate cash and receivables balances, above.

•During the three months ended June 30, 2022, the Company received non-dilutive funding of $0.3 million from the Trustees of Boston University under the Combating Antibiotic Resistant Bacteria Biopharmaceutical Accelerator ("CARB-X") program, in support of IND-enabling activities for SMT-738.

As of June 30, 2022, an aggregate of $1.2 million out of a potential of up to $7.8 million of funding has been received from CARB-X. Remaining potential funding from CARB-X has not been included in aggregate cash and receivables balances, above.

Operational & Corporate Updates

•Our intention is to expand our pipeline product portfolio in the therapeutic area of oncology and/or product offerings that are designed to work in harmony with the human gut microbiome. We intend to enact this through business development activities, including possible acquisitions and/or collaborations in addition to internal research and discovery efforts.

•In July 2022, we held a Type C meeting with the US Food & Drug Administration (the “FDA”) during which we discussed certain data from the Ri-CoDIFy Phase III clinical trial with the agency. The FDA and Summit discussed a possible pathway in which to advance ridinilazole forward with the goal of achieving marketing authorization. This pathway would involve at least one additional clinical trial. We plan to explore this possibility.

•During the second quarter of 2022, we continued to expand and bolster our leadership team to fit the expansive vision of our Company going forward. In doing so, we have appointed two individuals to positions of senior leadership, continuing to enhance the strong existing core leadership team and positioning the Company well for our strategic goals in the coming years.

◦In May, Ankur Dhingra joined Summit as our Chief Financial Officer. Mr. Dhingra was most recently the CFO of CareDx; previously, he spent over 15 years at Agilent Technologies, holding positions of increasing responsibility across its finance organization, including serving in multiple business unit CFO roles. Mr. Dhingra has over 20 years of progressive financial leadership experience in the fields of healthcare, medical devices, and technology and has assumed responsibility for Summit's human resources and information technology functions in addition to his finance responsibilities.

◦In April, Urte Gayko, PhD, was appointed as our Head of Regulatory, Safety, and Quality. Dr. Gayko, who is also a member of our Board of Directors, was most recently the Senior Vice President of Drug Development & Regulatory Affairs at Nektar Therapeutics; she was previously the Global Head of Regulatory Affairs and Pharmacovigilance at Pharmacyclics, Inc. Dr. Gayko has over 20 years of experience in regulatory affairs and clinical development ranging from pre-commercial entities to large biopharmaceutical companies, including Amgen and AbbVie.

•We are continuing to perform IND-enabling activities for our second drug candidate, SMT-738.

Summit Therapeutics’ Mission Statement

To build a viable, long-lasting health care organization that assumes full responsibility for designing, developing, trial execution and enrollment, regulatory submission and approval, and successful commercialization of patient, physician, caregiver, and societal-friendly medicinal therapy intended to: improve quality of life, increase potential duration of life, and resolve serious medical healthcare needs. To identify and control promising product candidates based on exceptional scientific development and administrational expertise, develop our products in a rapid, cost-efficient manner, and to engage commercialization and/or development partners when appropriate.

We accomplish this by building a team of world class professional scientists and business administrators that apply their experience and knowledge to this mission. Team Summit exists to pose, strategize, and execute a path forward in medicinal therapeutic health care that places Summit in a well-deserved, top market share,

leadership position. Team Summit assumes full responsibility for stimulating continuous expansion of knowledge, ability, capability, and well-being for all involved stakeholders and highly-valued shareholders.

About Summit Therapeutics

Summit was founded in 2003 and our shares are listed on the Nasdaq Global Market (symbol ‘SMMT’). We are headquartered in Menlo Park, California, and we have additional offices in Oxford, UK and Cambridge, UK.

For more information, please visit https://www.summittxinc.com and follow us on Twitter @summitplc.

Contact Summit Investor Relations:

Head of Stakeholder Relations & Corporate Strategy

david.gancarz@summitplc.com

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, potential acquisitions 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 results of our evaluation of the underlying data in connection with the topline results of our Phase III Ri-CoDIFy study evaluating ridinilazole, the outcome of discussions with regulatory authorities, including the Food and Drug Administration, the uncertainties inherent in the initiation of future clinical trials, availability and timing of data from ongoing and future clinical trials, the results of such trials, and their success, and 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, whether business development opportunities to expand the Company’s pipeline of drug candidates, including without limitation, through potential acquisitions of, and/or collaborations with, other entities occur, 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.

SUMMIT THERAPEUTICS, INC.

CONDENSED CONSOLIDATED STATEMENTS OF OPERATIONS AND COMPREHENSIVE LOSS

In thousands, except per share data


	Three Months Ended June 30,				Six Months Ended June 30,
	2022		2021		2022		2021
Revenue	$	235	$	57	$	485	$	249

Operating expenses:
Research and development	9,008		23,923		29,564		42,302
General and administrative	6,933		5,984		13,592		10,169
Total operating expenses	15,941		29,907		43,156		52,471
Other operating income	3,014		6,120		7,821		11,569
Operating loss	(12,692)		(23,730)		(34,850)		(40,653)
Other expense, net	(4,079)		(686)		(3,318)		(1,251)


Net loss	$	(16,771)	$	(24,416)	$	(38,168)	$	(41,904)

Basic and diluted loss per share	$	(0.17)	$	(0.27)	$	(0.38)	$	(0.48)

Comprehensive loss:
Net loss	$	(16,771)	$	(24,416)	$	(38,168)	$	(41,904)
Other comprehensive (loss) income:
Foreign currency translation adjustments	789		540		(971)		1,215
Comprehensive loss	$	(15,982)	$	(23,876)	$	(39,139)	$	(40,689)

CONDENSED CONSOLIDATED BALANCE SHEET INFORMATION


	June 30, 2022		December 31, 2021

Cash	$	57,335	$	71,791
Total assets	$	95,718	$	113,374
Total liabilities	$	44,401	$	30,090
Total stockholders' equity	$	51,317	$	83,284

CONDENSED CONSOLIDATED STATEMENTS OF CASH FLOWS INFORMATION


	Six Months Ended June 30,
	2022		2021

Net cash used in operating activities	$	(38,218)	$	(39,843)
Net cash used in investing activities	(654)		(190)
Net cash provided by financing activities	25,187		75,979
Effect of exchange rate changes on cash	(771)		1,023

(Decrease) Increase in cash	$	(14,456)	$	36,969