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Name | Symbol | Market | Type |
---|---|---|---|
Summit Therapeutics Inc | NASDAQ:SMMT | NASDAQ | Depository Receipt |
Price Change | % Change | Price | Bid Price | Offer Price | High Price | Low Price | Open Price | Traded | Last Trade | |
---|---|---|---|---|---|---|---|---|---|---|
-0.03 | -0.27% | 11.22 | 11.22 | 11.23 | 11.57 | 10.98 | 11.57 | 900,622 | 20:56:45 |
Enrollment Initiated in Second Phase III Clinical Study for Ivonescimab, HARMONi-3
Continuing Enrollment of HARMONi Phase III Study, with Enrollment Completion Expected in Second Half of 2024
Manmeet S. Soni Joined Summit as COO, Invested $5 Million in the Company
Dave Gancarz, Dr. Urte Gayko, Dr. Fong Clow, & Dr. Allen S. Yang Elevated to Leadership Positions
Dr. Jack West & Dr. Laura Chow Bolster Summit's Clinical Development Team with Combined 45+ Years of Lung Cancer, Immunotherapy, & Anti-Angiogenic Treatment Experience
Summit Therapeutics Inc. (NASDAQ: SMMT) ("Summit," "we," or the "Company") today reports its financial results and provides an update on operational progress for the third quarter and nine months ended September 30, 2023.
Operational & Corporate Updates
Financial Highlights
Third Quarter 2023 Earnings Call
Summit will host an earnings call this morning, Tuesday, November 7, 2023, at 9:00am ET. The conference call will be accessible by dialing (888) 210-3702 (toll-free domestic) or (646) 960-0191 (international) using conference code 5785899. A live webcast and instructions for joining the call are accessible through Summit’s website www.smmttx.com. An archived edition of the webcast will be available on our website after the call.
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 Ivonescimab
Ivonescimab, known as SMT112 in the United States, Canada, Europe, and Japan (Summit’s license territories), and as AK112 in China and Australia, is a novel, potential first-in-class investigational bispecific antibody combining the effects of immunotherapy via a blockade of PD-1 with the anti-angiogenesis effects associated with blocking VEGF into a single molecule. Ivonescimab was discovered by Akeso Inc. (HKEX Code: 9926.HK) and is currently engaged in multiple Phase III clinical trials. Summit has begun its clinical development of ivonescimab in NSCLC, commencing enrolling in its license territory in 2023 in two Phase III clinical trials. Over 950 patients have been treated with ivonescimab in clinical studies in China and Australia, with enrollment beginning recently in Summit's license territories.
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.
For more information, please visit https://www.smmttx.com and follow us on X (formerly Twitter) @summitplc.
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, 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 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, 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
(Unaudited)
In thousands, except per share data
Three Months Ended September 30,
Nine Months Ended September 30,
2023
2022
2023
2022
Revenue
$
—
$
220
$
—
$
705
Operating expenses:
Research and development
15,323
17,049
34,657
46,613
In-process research and development
—
—
520,915
—
General and administrative
5,434
5,573
18,690
19,165
Total operating expenses
20,757
22,622
574,262
65,778
Other operating income, net
265
5,462
822
13,283
Operating loss
(20,492
)
(16,940
)
(573,440
)
(51,790
)
Other (expense) income, net
(776
)
(4,445
)
(4,921
)
(7,763
)
Net loss
$
(21,268
)
$
(21,385
)
$
(578,361
)
$
(59,553
)
Basic and diluted loss per share
$
(0.03
)
$
(0.10
)
$
(0.98
)
$
(0.37
)
Comprehensive loss:
Net loss
$
(21,268
)
$
(21,385
)
$
(578,361
)
$
(59,553
)
Other comprehensive (loss) income:
Foreign currency translation adjustments
108
(49
)
(20
)
(1,020
)
Reclassification of cumulative currency translation gain to other (expense) income, net
—
—
(419
)
—
Net changes related to short-term investments
6
—
9
—
Comprehensive loss
$
(21,154
)
$
(21,434
)
$
(578,791
)
$
(60,573
)
CONDENSED CONSOLIDATED BALANCE SHEET INFORMATION
(Unaudited)
In thousands
September 30, 2023
December 31, 2022
Cash, Restricted Cash, Short-term Investments
$
198,945
$
648,607
Total assets
$
218,476
$
664,168
Total liabilities
$
119,097
$
537,514
Total stockholders' equity
$
99,379
$
126,654
CONDENSED CONSOLIDATED STATEMENTS OF CASH FLOWS INFORMATION
(Unaudited)
In thousands
Nine Months Ended September 30,
2023
2022
Net cash used in operating activities
$
(57,301
)
$
(46,773
)
Net cash used in investing activities
(648,342
)
(634
)
Net cash provided by financing activities
80,261
100,184
Effect of exchange rate changes on cash
567
(2,597
)
(Decrease) increase in cash and cash equivalents
$
(624,815
)
$
50,180
View source version on businesswire.com: https://www.businesswire.com/news/home/20231107407341/en/
Contact Summit Investor Relations: Dave Gancarz Chief Business & Strategy Officer investors@smmttx.com
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