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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): January 6, 2023
 
Summit Therapeutics Inc.
(Exact Name of Registrant as Specified in Its Charter)
   
Delaware001-3686637-1979717
(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 ClassTrading Symbol(s)Name of Each Exchange on Which Registered
Common stock, $0.01 par value per shareSMMTThe 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.

As of December 31, 2022, the Company’s preliminary unaudited balance of cash, cash equivalents and amounts included in escrow was no less than $648 million (which includes the $300 million upfront payment to Akeso, Inc. (“Akeso”), to be paid by the Company pursuant to the Collaboration and License Agreement (the “License Agreement”) which the Company entered into with Akeso on December 5, 2022, and which amount was transferred by the Company into an escrow account, to be released to Akeso (less certain deductions) at such time as all applicable waiting periods under the Hart-Scott-Rodino Antitrust Improvements Act of 1976 and any comparable extension periods with respect to the transactions contemplated by the License Agreement have expired or been terminated). This $648 million amount is preliminary and is subject to completion of financial closing procedures. As a result, this amount may differ materially from the amount that will be reflected in the Company’s consolidated financial statements for the year ended December 31, 2022.

The information in Item 2.02 of this Current Report on Form 8-K 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 (the “Securities Act”), or the Exchange Act, except as expressly set forth by specific reference in such filing.


Item 5.07
Submission of Matters to a Vote of Security Holders.

On January 6, 2023, Summit Therapeutics Inc. (the “Company”) held a Special Meeting of Stockholders (the “Special Meeting”). The following matters were submitted to a vote of the Company’s stockholders at the Special Meeting: (i) an amendment to the Company’s Restated Certificate of Incorporation, dated September 18, 2020, as amended on July 27, 2022 (the “Restated Certificate”), to increase the number of authorized shares of common stock by 650,000,000 (from 350,000,000 to 1,000,000,000); and (ii) an amendment to the Restated Certificate to effect a reverse stock split of all of the outstanding shares of the Company’s common stock at a ratio in the range of 1-for-5 to 1-for-10.

Each of the matters submitted to a vote of the Company’s stockholders at the Special Meeting was approved by the requisite vote of the Company’s stockholders in accordance with the recommendation of the Company’s Board of Directors. The final decision of whether to proceed with the amendments shall be determined by our board of directors, in its discretion, at any time prior to January 6, 2024. Set forth below is the number of votes cast for, against or withheld as to each such matter (no broker non-votes were received):

Proposal 1ForAgainstAbstainBroker
Amendment No. 2 to Restated Certificate of Incorporation to increase the number of authorizes shares of common stock188,470,0281,585,907165,798—

Proposal 2ForAgainstAbstainBroker
Amendment No. 2 to Restated Certificate of Incorporation to effect a reverse stock split of the outstanding common stock186,585,8213,607,72128,191—






Item 7.01
Regulation FD Disclosure.

Summit Therapeutics Inc. (the “Company”) will participate in and present at the 41st Annual J.P Morgan Healthcare Conference on Monday, January 9, 2023, at 3:45 p.m. (PST). Robert W. Duggan, Chairman and Chief Executive Officer, and Dr. Maky Zanganeh, Co-Chief Executive Officer and President, will provide details regarding the Company following the announcement of the agreement to in-license the breakthrough innovative bispecific antibody, ivonescimab (SMT112).
A live audio link of the Company’s presentation (the “Presentation”) will be available from the Company’s website at www.summittxinc.com.

Pursuant to Regulation FD, the Company hereby furnishes the presentation slides from the Presentation.

The information furnished by the Company pursuant to this item, including Exhibit 99.1 and any information provided at the Presentation, 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 liability of that section, and shall not be deemed to be incorporated by reference into any Company filing under the Securities Act of 1933, as amended, or the Exchange Act, regardless of any general incorporation language in such filing.


Item 9.01
Financial Statements and Exhibits.

(d) Exhibits

Exhibit Number
Description
104Cover Page Interactive Data File (embedded within 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, hereunto duly authorized.
 SUMMIT THERAPEUTICS INC.
  
  
Date: January 9, 2023By:/s/ Ankur Dhingra
  Chief Financial Officer
  (Principal Financial Officer)
J.P. Morgan 41st Annual Healthcare Conference 2023 Bob Duggan Dr. Maky Zanganeh Chairman & CEO Co-CEO, President & Board Member

 
2 Disclaimer and Forward-Looking Statement Any statements in this presentation 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, entry into and actions related to the Company’s partnership with Akeso Inc., 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 6 the development and commercialization activities for SMT112, 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 SMT112. Accordingly, the audience 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 presentation 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 presentation. J.P. Morgan 41st Annual Healthcare Conference, January 2023 Summit Proprietary Information - Do Not Copy, Photograph or Distribute

 
Summit Therapeutics, Inc. Overview NASDAQ LISTED COMPANY SMMT Menlo Park, CA Oxford & Cambridge, UK OFFICES 2020 Became a US Entity Listed on NASDAQ Assembled a World-Class Team 2021 Signed Licensing Agreement Between Summit and Akeso for Ivonescimab (Novel Bispecific Antibody for Development in Oncology) 2022 3 J.P. Morgan 41st Annual Healthcare Conference, January 2023 Summit Proprietary Information - Do Not Copy, Photograph or Distribute Ivonescimab is an investigational therapy that is not approved by any regulatory authority: It is currently being investigated in Phase III clinical studies.

 
WHERE WE ARE GOING Building a Company with IMPACT Focused on novel innovations ꟷ Developing ivonescimab across multiple oncology indications ꟷ In-house discovery and research on oncology molecules WHO WE ARE Leadership with Game-Changing Experience Leaders with global oncology experience Proven track record in all aspects of drug development, regulatory approval and commercialization High-speed execution Summit Therapeutics 4 J.P. Morgan 41st Annual Healthcare Conference, January 2023 Summit Proprietary Information - Do Not Copy, Photograph or Distribute Ivonescimab is an investigational therapy that is not approved by any regulatory authority: It is currently being investigated in Phase III clinical studies.

 
Partnership with Akeso

 
Strategic Partnership with an Aligned Mission Bringing Ivonescimab to Patients in Need Summit Therapeutics SMT112 United States, Canada, Europe & Japan (Summit License Territories) Akeso AK112 China & Non-Summit Territories 6 J.P. Morgan 41st Annual Healthcare Conference, January 2023 Summit Proprietary Information - Do Not Copy, Photograph or Distribute Ivonescimab is an investigational therapy that is not approved by any regulatory authority: It is currently being investigated in Phase III clinical studies. Subject to Hart-Scott-Rodino (HSR) Act

 
Akeso: A Pioneer in Developing Innovative Antibodies 7 J.P. Morgan 41st Annual Healthcare Conference, January 2023 Summit Proprietary Information - Do Not Copy, Photograph or Distribute Focus on innovative therapeutic antibodies Founded in 2012 Headquartered in Zhongshan (near Hong Kong) China Listed on the Hong Kong Exchange $4.9B valuation (January 6, 2023) 2,300 employees Complete in-house functions from discovery and target validation to clinical development and sales 31,500L production capacity More than 92,000L of additional manufacturing capacity under construction ACE Platform TETRABODY Technology Akeso has one of the richest and most diversified antibody drug pipeline in China Over 30 internally developed candidates including 6 bispecific antibodies More than 80 clinical trials for 17 drug candidates 15 pivotal/phase III trials Akeso, Inc | Pipelines (akesobio.com) MICHELLE XIA, PH.D. Co-Founder, Chairwoman, President, and CEO Akeso, Inc. Being nominated to the Summit Therapeutics Board of Directors Subject to Hart-Scott-Rodino (HSR) Act

 
Ivonescimab (SMT112) PD-1/VEGF Bispecific Antibody Overview

 
Ivonescimab (SMT112) PD-1/VEGF Bispecific Antibody Anti-VEGF Anti-PD-1 Ivonescimab is a novel potential first-in-class bispecific antibody combining the effects of immunotherapy via a blockade of PD-1 with the anti-angiogenesis effects associated with blocking of VEGF into a single molecule 9 J.P. Morgan 41st Annual Healthcare Conference, January 2023 Summit Proprietary Information - Do Not Copy, Photograph or Distribute Ivonescimab is an investigational therapy that is not approved by any regulatory authority: It is currently being investigated in Phase III clinical studies.

 
SMT112 Simultaneous blockage of PD-1 & VEGF provides enhanced anti- tumor activities Tighter binding and higher specificity enhances T cell activation Tumor Microenvironment Without PD-1 or VEGF Antibodies With Ivonescimab (SMT112) PD-1/VEGF Bispecific Antibody 2. VEGF induces angiogenesis which give nutrients and oxygen to the tumor 1. PD-1 acts as a checkpoint which slows down the killing of the tumor 1. SMT112 blocks PD-1, which stimulates the immune system to fight the tumor 2. SMT112 also blocks VEGF diminishing angiogenesis thereby starving the tumor 10 J.P. Morgan 41st Annual Healthcare Conference, January 2023 Summit Proprietary Information - Do Not Copy, Photograph or Distribute Ivonescimab is an investigational therapy that is not approved by any regulatory authority: It is currently being investigated in Phase III clinical studies.

 
• The most advanced PD-1/VEGF bispecific antibody in clinical development • Received breakthrough therapy designation status in China for three indications1 • Combined with chemotherapy for NSCLC patients who have failed a previous EGFR-TKI • Combined with chemotherapy for NSCLC patients who have failed to respond to a prior PD-(L)1 therapy • Monotherapy as first-line treatment for locally advanced or metastatic NSCLC patients with positive PD-L1 expression • Currently being investigated in Phase III clinical trials in China Ivonescimab (SMT112) PD-1/VEGF Bispecific Antibody 11 J.P. Morgan 41st Annual Healthcare Conference, January 2023 Summit Proprietary Information - Do Not Copy, Photograph or Distribute Ivonescimab is an investigational therapy that is not approved by any regulatory authority: It is currently being investigated in Phase III clinical studies. NSCLC = Non-Small-Cell Lung Cancer 1. Akeso. November 13, 2022. Akeso’s Ivonescimab (PD-1/VEGF Bispecific Antibody, AK112) Granted Breakthrough Therapy Designation for I-O Resistance NSCLC Patients in China. [Press Release]. https://www.akesobio.com/en/media/akeso-news/20221113.

 
Ivonescimab Clinical Overview

 
13 J.P. Morgan 41st Annual Healthcare Conference, January 2023 Summit Proprietary Information - Do Not Copy, Photograph or Distribute Ivonescimab is an investigational therapy that is not approved by any regulatory authority: It is currently being investigated in Phase III clinical studies. Zhao Y, et al. ASCO 2022 poster #9040 (NCT04900363) Clinical Overview Phase Ib/II Study IVONESCIMAB, Monotherapy for Non-Small Cell Lung Cancer (NSCLC) NCT04900363 – Study Design

 
Study Results 14 J.P. Morgan 41st Annual Healthcare Conference, January 2023 Summit Proprietary Information - Do Not Copy, Photograph or Distribute Ivonescimab is an investigational therapy that is not approved by any regulatory authority: It is currently being investigated in Phase III clinical studies. Ivonescimab Monotherapy Phase Ib/II Presented at ASCO 2022 Advanced or Metastatic NSCLC Patients (N=96) ORR = 50% (TPS 1-49%; N=22) ORR = 76.9% (TPS ≥50%; N=13) TPS = PD-L1 tumor proportion score NCT04900363 First-line treatment ≥20 mg/kg Zhou C, et al. ASCO 2022 poster #9040 • Ivonescimab monotherapy was generally well tolerated • Grade 3-4 treatment-related adverse events occurred in 13.5% • No treatment-related adverse events lead to permanent treatment discontinuation SafetyBest percentage change in tumor size from baseline

 
15 J.P. Morgan 41st Annual Healthcare Conference, January 2023 Summit Proprietary Information - Do Not Copy, Photograph or Distribute Ivonescimab is an investigational therapy that is not approved by any regulatory authority: It is currently being investigated in Phase III clinical studies. Zhao Y, et al. ASCO 2022 poster #9019 (NCT04736823) Clinical Overview Phase II IVONESCIMAB (PD-1/VEGF Bispecific Antibody) + Chemo in Non-Small Cell Lung Cancer (NSCLC) NCT04736823 – Study Design

 
Study Results 16 J.P. Morgan 41st Annual Healthcare Conference, January 2023 Summit Proprietary Information - Do Not Copy, Photograph or Distribute Ivonescimab is an investigational therapy that is not approved by any regulatory authority: It is currently being investigated in Phase III clinical studies. Ivonescimab Combination Therapy Phase II Presented at ASCO 2022 1L NSCLC Locally Advanced or Metastatic Patients Squamous (N=18) ORR=77.8% 95% CI (52.4 – 93.6) NCT04736823 † As of Mar 20, 2022, median duration of follow up was 9.2 months (range: 7.7 – 9.7) for Cohort 1 Best percentage change in tumor size from baseline Non-Squamous (N=25) ORR=52% 95% CI (31.3 – 72.2) Zhao Y, et al. ASCO 2022 poster #9019 +20% -30% Cohort 1 Squamous cell carcinoma Cohort 1 Non-squamous cell carcinoma

 
Study Results 17 J.P. Morgan 41st Annual Healthcare Conference, January 2023 Summit Proprietary Information - Do Not Copy, Photograph or Distribute Ivonescimab is an investigational therapy that is not approved by any regulatory authority: It is currently being investigated in Phase III clinical studies. Ivonescimab Combination Therapy Phase II Presented at ASCO 2022 2L+ NSCLC Locally Advanced or Metastatic Patients who Progressed on EGFR-TKI NCT04736823 †As of Mar 20, 2022, median duration of follow up was 7.0 months (range: 5.6 - 7.1) for Cohort 2 Zhao Y, et al. ASCO 2022 poster #9019 N=19 ORR = 68.4% 95% CI (43.4 – 87.4) Cohort 2 Best percentage change in tumor size from baseline

 
Study Results 18 J.P. Morgan 41st Annual Healthcare Conference, January 2023 Summit Proprietary Information - Do Not Copy, Photograph or Distribute Ivonescimab is an investigational therapy that is not approved by any regulatory authority: It is currently being investigated in Phase III clinical studies. ‡As of Mar 20, 2022, median duration of follow up was 5.9 months (range: 4.4 – 6.9) for Cohort 3 NCT04736823 Ivonescimab Combination Therapy Phase II Presented at ASCO 2022 2L+ NSCLC Locally Advanced or Metastatic Patients who Progressed on PD-(L)1 Zhao Y, et al. ASCO 2022 poster #9019 N=20 ORR = 40.0% 95% CI (19.1 – 63.9) Best percentage change in tumor size from baseline Cohort 3

 
19 J.P. Morgan 41st Annual Healthcare Conference, January 2023 Summit Proprietary Information - Do Not Copy, Photograph or Distribute Ivonescimab is an investigational therapy that is not approved by any regulatory authority: It is currently being investigated in Phase III clinical studies. • Ivonescimab in combination with various chemotherapies was generally well tolerated in 82 patients • Serious treatment related adverse events occurred in 18% • Treatment related adverse events leading to permanent treatment discontinuation occurred in 4% • There was no clinical difference in the incidence of treatment related safety events of any grade between squamous (80%) and non-squamous histologies (88%) or serious events (28% vs. 21%), respectively NCT04736823 Safety Ivonescimab Phase II Safety Results Presented at ASCO 2022 Combination with Chemotherapy Across 3 Cohorts Zhou C, et al. ASCO 2022 poster #9019

 
Lead Indications: NSCLC Ivonescimab (SMT112) PD-1/VEGF Bispecific Antibody

 
1. Lung Cancer Fact Sheet | American Lung Association 2. Lung Cancer Facts: 29 Statistics and Facts | LCFA (lcfamerica.org) 3. What Is Lung Cancer? | Types of Lung Cancer Lung Cancer Leading cause of death in cancer patients in the U.S.1 Every 4 minutes someone in the U.S. dies of lung cancer 2 236,740 130,180 $24B Estimated 236,740 people in the U.S. were diagnosed in 20222 Estimated 130,180 deaths occurred in the U.S. in 20222 Estimated $24 billion approximate U.S. costs spent on lung cancer care in 20202 Non-Small Cell Lung Cancer (NSCLC) is 80%+ of all lung cancer3 21 J.P. Morgan 41st Annual Healthcare Conference, January 2023 Summit Proprietary Information - Do Not Copy, Photograph or Distribute

 
Summit Therapeutics Oncology Pipeline 22 J.P. Morgan 41st Annual Healthcare Conference, January 2023 Summit Proprietary Information - Do Not Copy, Photograph or Distribute Subject to Hart-Scott-Rodino (HSR) Act Ivonescimab is an investigational therapy that is not approved by any regulatory authority: It is currently being investigated in Phase III clinical studies. *Phase I and II has been completed by our partner Akeso, Phase III clinical studies are planned to be initiated either independently or jointly with our partner Akeso in 2023/24

 
Licensing Agreement with Akeso & Financial Details

 
In-Licensing and Financial Update 24 J.P. Morgan 41st Annual Healthcare Conference, January 2023 Summit Proprietary Information - Do Not Copy, Photograph or Distribute Subject to Hart-Scott-Rodino (HSR) Act • Upfront payment: $500 million ꟷ $25 million to be paid via 10 million shares; the remainder to be paid in cash • Milestones: • Regulatory milestones of up to $1.05 billion • Commercial milestones of up to $3.45 billion • Low double-digit royalties on net sales THE DEAL FINANCIAL POSITION • Cash position: $649 million as of December 31, 2022 ꟷ $174 million for continuing operations after upfront payments ꟷ Cash runway into mid 2024 • $500 million rights offering upcoming: ꟷ $420 million to repay a portion of the debt ꟷ $80 million to add to our cash balance

 
J.P. Morgan 41st Annual Healthcare Conference 2023 Q&A Bob Duggan Dr. Maky Zanganeh Chairman & CEO Co-CEO, President & Board Member