Finch Therapeutics Group, Inc. (“Finch” or “Finch Therapeutics”) (Nasdaq: FNCH), a clinical-stage microbiome therapeutics company leveraging its Human-First Discovery® platform to develop a novel class of orally administered biological drugs, today provided a corporate update and reported financial results for the first quarter ended March 31, 2022.
“Finch made several important strides this quarter, including the resolution of the FDA clinical hold previously placed on our IND for CP101. We are pleased to have addressed the FDA’s questions related to our SARS-CoV-2 screening procedures and look forward to completing the additional activities that we believe will enable us to proceed with enrollment in PRISM4, our Phase 3 trial of CP101 in recurrent C. difficile infection,” said Mark Smith, PhD, Chief Executive Officer of Finch Therapeutics. “We are also preparing to advance FIN-211 into the clinic, which is our investigational microbiome therapeutic in development for children with autism and significant GI symptoms. We recently made several modifications to the design of AUSPIRE, our Phase 1b trial of FIN-211, such as the addition of a placebo arm which we believe will enable us to draw more meaningful insights into the potential impact of FIN-211 on behavioral and GI symptoms.”
Dr. Smith continued, “With our recent decision to prioritize our C. difficile and autism programs, in addition to our Takeda-partnered work in inflammatory bowel disease, and the recent debt financing with Hercules Capital, we believe that we are well positioned to execute upon our mission and strategic priorities, with expected cash runway through key clinical milestones, including topline data from PRISM4 and initial safety data from AUSPIRE.”
Recent Program Highlights
CP101 for the Prevention of Recurrent C. difficile Infection (CDI):
FIN-211 for Autism Spectrum Disorder (ASD) with Significant Gastrointestinal (GI) Symptoms:
Recent Corporate Updates
Corporate Update Conference Call and Webcast
Finch management will host a conference call and live webcast on Monday, May 16, 2022, at 8:00 am ET to discuss updates to its development programs and other business highlights. The conference call can be accessed by dialing (833) 649-1186 (domestic) or (270) 823-1080 (international) and entering conference ID 8451806. The live webcast can be accessed by visiting the “Investors & News” section of the Finch website and selecting “Events & Presentations.” The webcast will be archived on the website for approximately 30 days following the event.
First Quarter 2022 Financial Results
About Finch Therapeutics
Finch Therapeutics is a clinical-stage microbiome therapeutics company leveraging its Human-First Discovery® platform to develop a novel class of orally administered biological drugs. With the capabilities to develop both complete and targeted microbiome therapeutics, Finch is advancing a rich pipeline of candidates designed to address a wide range of unmet medical needs. Finch’s lead candidate, CP101, is in late-stage clinical development for the prevention of recurrent C. difficile infection and has received Breakthrough Therapy and Fast Track designations from the U.S. Food and Drug Administration. Finch is also developing FIN-211 for children with autism spectrum disorder and significant gastrointestinal symptoms. Finch has a partnership with Takeda focused on the development of targeted microbiome therapeutics for inflammatory bowel disease. We routinely post information that may be important to our investors on our website at www.finchtherapeutics.com. The Company encourages investors to consult the “Investors & News” section of its website regularly.
Human-First Discovery® is a registered trademark of Finch Therapeutics Group, Inc.
Forward-Looking Statements
This press release includes “forward-looking statements.” Words such as “will,” "anticipates," "believes," "expects," "intends," “plans,” “potential,” "projects,” “would” and "future" or similar expressions are intended to identify forward-looking statements. These forward-looking statements include, but are not limited to, statements regarding: Finch’s ability to execute upon its mission and strategic priorities; Finch’s ability to complete additional activities that it believes will enable it to proceed with enrollment in PRISM4 and the anticipated timeline for results from the trial; the design of Finch’s AUSPIRE trial, Finch’s plans to advance FIN-211 into the clinic and the anticipated timeline for submitting an IND for FIN-211; the potential for the modifications to the AUSPIRE trial design to enable the company to draw more meaningful insights into the potential impact of FIN-211 on behavioral and GI symptoms; the workforce reduction and Finch’s ability to focus its financial resources on its existing development programs; Finch’s ability to build its platform and plan for its future development of commercial supply needs; and Finch's anticipated runway, including accessing additional sources of capital. Because such statements are subject to risks and uncertainties, actual results may differ materially from those expressed or implied by such forward-looking statements. These risks and uncertainties include, among others: the risk that correspondence from the FDA may require Finch to collect additional data or information beyond what it currently expects, as well as unexpected regulatory actions or delays, including requests for additional safety and/or efficacy data or analysis of data, or government regulation generally; uncertainties relating to regulatory applications and related filing and approval timelines; Finch’s limited operating history and historical losses; Finch’s ability to raise additional funding to complete the development and any commercialization of its product candidates; Finch’s dependence on the success of its lead product candidate, CP101; the possibility that Finch may be delayed in initiating, enrolling or completing any clinical trials; results of clinical trials may not be indicative of final or future results from later stage or larger clinical trials (or in broader patient populations once the product is approved for use by regulatory agencies) or may not be favorable or may not support further development; Finch’s product candidates, including CP101 and FIN-211 may not generate the benefits to patients that are anticipated; results of clinical trials may not be sufficient to satisfy regulatory authorities to approve Finch’s product candidates in their targeted or other indications (or such authorities may request additional trials or additional information); Finch’s ability to comply with regulatory requirements; ongoing regulatory obligations and continued regulatory review may result in significant additional expense to Finch and Finch may be subject to penalties for failure to comply; competition from third parties that are developing products for similar uses; Finch’s ability to maintain patent and other intellectual property protection and the possibility that Finch’s intellectual property rights may be infringed, invalid or unenforceable or will be threatened by third parties; Finch’s ability to qualify and scale its manufacturing capabilities in anticipation of commencement of multiple global clinical trials; Finch’s lack of experience in selling, marketing and distributing its product candidates; Finch’s dependence on third parties in connection with manufacturing, clinical trials and preclinical studies; and risks relating to the impact and duration of the COVID-19 pandemic on Finch’s business. These and other risks are described more fully in Finch’s filings with the Securities and Exchange Commission (“SEC”), including the section titled “Risk Factors” in Finch’s Annual Report on Form 10-K for the year ended December 31, 2021 filed with the SEC on March 31, 2022, as well as discussions of potential risks, uncertainties, and other important factors in Finch’s other filings with the SEC. All forward-looking statements contained in this press release speak only as of the date on which they were made. Except to the extent required by law, Finch undertakes no obligation to update such statements to reflect events that occur or circumstances that exist after the date on which they were made.
Investor Contact:
Stephen Jasper
Gilmartin Group
(858) 525-2047
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Media Contact:
Jenna Urban
Berry & Company Public Relations
(212) 253-8881
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Finch Therapeutics Group, Inc.
Condensed Consolidated Statements of Operations (Unaudited)
(in thousands, except share and per share data)
FOR THE THREE MONTHS ENDED MARCH 31, | ||||||||
2022 | 2021 | |||||||
Revenue: | ||||||||
Collaboration revenue | $ | 354 | $ | 3,553 | ||||
Total revenue | 354 | 3,553 | ||||||
Operating expenses: | ||||||||
Research and development | 15,530 | 12,975 | ||||||
General and administrative | 9,404 | 4,552 | ||||||
Total operating expenses | 24,934 | 17,527 | ||||||
Loss from operations | (24,580 | ) | (13,974 | ) | ||||
Other income (expense) | 13 | (7 | ) | |||||
Net loss | $ | (24,567 | ) | $ | (13,981 | ) | ||
Net loss per share attributable to common stockholders—basic and diluted | $ | (0.52 | ) | $ | (1.00 | ) | ||
Weighted-average common stock outstanding—basic and diluted | 47,528,948 | 14,033,273 |
Finch Therapeutics Group, Inc.
Condensed Consolidated Balance Sheet Data (Unaudited)
(in thousands)
MARCH 31, 2022 | DECEMBER 31, 2021 | |||||||
Assets: | ||||||||
Cash and cash equivalents | $ | 106,931 | $ | 133,481 | ||||
Other assets | 97,702 | 91,888 | ||||||
Total assets | $ | 204,633 | $ | 225,369 | ||||
Liabilities, redeemable convertible preferred stock and stockholders' equity | ||||||||
Liabilities | 24,842 | 23,145 | ||||||
Stockholders' equity | 179,791 | 202,224 | ||||||
Total liabilities, redeemable convertible preferred stock and stockholders' equity | $ | 204,633 | $ | 225,369 |
Last Trade: | US$11.69 |
Daily Change: | 9.89 549.44 |
Daily Volume: | 5,850 |
Market Cap: | US$18.820M |
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