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 reported financial results for the third quarter ended September 30, 2021 and provided business updates.
“We are pleased to have recently shared additional positive clinical data supporting our lead candidate CP101 for the prevention of recurrent C. difficile infection, including new topline data from our PRISM-EXT Phase 2 open label trial, as well as additional data from our PRISM3 Phase 2 trial that were presented at this year’s ACG meeting. These data highlight the growing evidence and momentum supporting our lead candidate, and more broadly, provide a firm foundation for the development of the next wave of candidates in our growing pipeline,” said Mark Smith, PhD, Chief Executive Officer of Finch Therapeutics. “As we look ahead, Finch is poised to enter a transformational period, with a Phase 3 trial underway for CP101 and our development programs targeting autism and chronic hepatitis B infection scheduled to enter the clinic in 2022. We believe that readouts from these next programs will further demonstrate the potential for microbiome therapeutics to become the next new modality that transforms patient care across multiple therapeutic areas.”
Recent Highlights
Leadership Updates:
Key Anticipated Milestones
Third Quarter 2021 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 (CDI), and has received Breakthrough Therapy and Fast Track designations from the U.S. Food and Drug Administration. In June 2020, Finch announced that CP101 met its primary efficacy endpoint in PRISM3, the first of two pivotal trials to support the development of CP101 for the prevention of recurrent CDI. PRISM4, a Phase 3 trial, is designed to serve as the second pivotal trial of CP101 for recurrent CDI. Finch is also developing CP101 for the treatment of chronic hepatitis B virus infection, and FIN-211 for the treatment of the gastrointestinal and behavioral symptoms of autism spectrum disorder. Finch has a partnership with Takeda focused on the development of targeted microbiome therapeutics for inflammatory bowel disease.
Human-First Discovery® is a registered trademark of Finch Therapeutics Group, Inc.
Forward-Looking Statements
Statements contained in this press release regarding matters that are not historical facts are “forward-looking statements” within the meaning of the Private Securities Litigation Reform Act of 1995, as amended. Words such as "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: the structure and timing of Finch’s clinical trials and the period during which the results of trials will be available, including specifically the total enrollment of PRISM4, Finch’s Phase 3 clinical trial in CDI and the initiation of Phase 1 trials in ASD and chronic HBV, and the release of topline data from each of those trials; Finch’s ability to advance the development of a novel class of therapeutics, including through the manufacture of its product candidates at its newly completed manufacturing facility; and the therapeutic value, development, and commercial potential of microbiome therapeutics. 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: 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 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); 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; anticipated regulatory approvals may be delayed or refused; 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 Quarterly Report on Form 10-Q filed with the SEC on August 10, 2021, 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:
Laurence Watts
Gilmartin Group
(619) 916-7620
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or
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 SEPTEMBER 30, | FOR THE NINE MONTHS ENDED SEPTEMBER 30, | |||||||||||||||
2021 | 2020 | 2021 | 2020 | |||||||||||||
Revenue: | ||||||||||||||||
Collaboration revenue | $ | 11,343 | $ | 1,733 | $ | 17,726 | $ | 5,582 | ||||||||
Royalty revenue from related party | — | 38 | — | 330 | ||||||||||||
Total revenue | 11,343 | 1,771 | 17,726 | 5,912 | ||||||||||||
Operating expenses: | ||||||||||||||||
Research and development | 15,537 | 9,045 | 42,476 | 24,577 | ||||||||||||
General and administrative | 5,739 | 2,807 | 16,173 | 7,639 | ||||||||||||
Total operating expenses | 21,276 | 11,852 | 58,649 | 32,216 | ||||||||||||
Loss from operations | (9,933 | ) | (10,081 | ) | (40,923 | ) | (26,304 | ) | ||||||||
Other (expense) income | (22 | ) | (9 | ) | 1,818 | 54 | ||||||||||
Net loss | $ | (9,955 | ) | $ | (10,090 | ) | $ | (39,105 | ) | $ | (26,250 | ) | ||||
Net loss per share attributable to common stockholders—basic and diluted | $ | (0.21 | ) | $ | (1.22 | ) | $ | (1.07 | ) | $ | (3.25 | ) | ||||
Weighted-average common stock outstanding—basic and diluted | 47,445,195 | 8,258,537 | 36,408,506 | 8,065,730 | ||||||||||||
Finch Therapeutics Group, Inc.
Condensed Consolidated Balance Sheet Data (Unaudited)
(in thousands)
SEPTEMBER 30, 2021 | DECEMBER 31, 2020 | |||||||
Assets: | ||||||||
Cash and cash equivalents | $ | 149,200 | $ | 99,710 | ||||
Other assets | 83,779 | 65,628 | ||||||
Total assets | $ | 232,979 | $ | 165,338 | ||||
Liabilities, redeemable convertible preferred stock and stockholders' equity (deficit) | ||||||||
Liabilities | 13,178 | 28,002 | ||||||
Redeemable convertible preferred stock | — | 233,054 | ||||||
Stockholders' equity (deficit) | 219,801 | (95,718 | ) | |||||
Total liabilities, redeemable convertible preferred stock and stockholders' equity (deficit) | $ | 232,979 | $ | 165,338 |
Last Trade: | US$11.69 |
Daily Change: | 9.89 549.44 |
Daily Volume: | 5,850 |
Market Cap: | US$18.820M |
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