GlobeNewswire Inc | Aug 10, 2021 07:05AM EDT

August 10, 2021

-- Takeda to accelerate leadership role in advancing FIN-524/TAK-524 ulcerative colitis development program -- Topline safety and efficacy data from more than 130 recurrent CDI patients treated with CP101 in open label PRISM-EXT trial expected in H2 2021 -- Continued progress advancing development programs, withclinical data across multiple programs anticipated in 2022

SOMERVILLE, Mass., Aug. 10, 2021 (GLOBE NEWSWIRE) -- 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 second quarter ended June 30, 2021 and provided a business update.

The Finch team has made tremendous progress executing on our clinical development plans and positioning Finch for important data readouts next year from trials evaluating FIN-211 in children with autism and GI symptoms and CP101 in adults with chronic hepatitis B infection, said Mark Smith, PhD, Chief Executive Officer of Finch Therapeutics. We believe these readouts, as well as the upcoming readout from our open-label trial of CP101 in recurrent C. difficile, will build on the clinical results we have demonstrated thus far with our lead candidate CP101 and highlight the broad potential of the differentiated platform we have built to translate insights from compelling clinical data into novel product candidates. In addition to our current portfolio, we continue to make progress across multiple discovery-stage programs that offer exciting new opportunities to leverage our Human-First Discovery platform.

Recent Highlights

-- Takeda to Accelerate Leadership Role in FIN-524/TAK-524 Ulcerative Colitis Development Program: In August 2021, Finch announced that Takeda elected to accelerate the transition of development responsibility for FIN-524/TAK-524, a targeted consortia product candidate developed by Finch and Takeda for the treatment of ulcerative colitis. The transition will enable Takeda to leverage its expertise in inflammatory bowel disease (IBD) throughout the clinical development of FIN-524/TAK-524. -- Continued Progress Advancing Development of CP101 Programs:CP101 for Recurrent CDI: Finch has completed several key trial start-up activities, including the receipt of central IRB approval, for the PRISM4 Phase 3 trial which is designed to serve as the second pivotal trial of CP101 for recurrent C. difficile infection (CDI).CP101 for Chronic HBV: Building on KOL feedback and existing third-party clinical data, Finch has decided to expand RECLAIM, a planned Phase 1b trial of CP101 in chronic hepatitis B (HBV), from two cohorts to four cohorts. RECLAIM will now evaluate CP101 in four HBV subpopulations including two cohorts of HBeAg positive patients with low and high viral DNA levels respectively and two cohorts of HBeAg negative patients, one on oral antivirals and a second that is treatment nave. These changes to the trial design are designed to enhance the ability to detect a signal among key exploratory endpoints, including levels of surface antigen, e-antigen, viral DNA, and immunological biomarkers. With these refinements to the trial design and our allocation of available drug supply across our portfolio, RECLAIM is anticipated to initiate in early 2022, with an initial safety readout in the first half of 2022 and topline data from multiple cohorts available in the second half of 2022.

-- Expanded Leadership Team and Board of Directors: Finch appointed Stephen Klincewicz, DO, MPH, JD to Vice President of Drug Safety and Pharmacovigilance in June 2021. Additionally, Finch announced in April 2021 the appointment of Susan E. Graf to its Board of Directors.

Key Anticipated Upcoming Milestones

-- Topline 8-week and 6-month data from PRISM-EXT, an open-label trial evaluating the safety and efficacy of CP101 for recurrent CDI in over 130 patients, is anticipated in the second half of 2021 and topline data from the PRISM4 Phase 3 trial of CP101 in recurrent CDI is anticipated in the first half of 2023. -- Topline data from a Phase 1b trial of FIN-211 in children with autism spectrum disorder (ASD) and gastrointestinal symptoms and a Phase 1b trial of CP101 in chronic HBV are anticipated in the second half of 2022.

Second Quarter 2021 Financial Results

-- Finch reported a net loss of $15.2 million for the second quarter of 2021 as compared to a net loss of $8.3 million for the same period in 2020. The increase was largely due to increased research and development expenses, as well as increased costs related to the infrastructure needed to support Finchs growth. -- Research and development expenses for the second quarter of 2021 were $14.0 million, compared with $8.1 million for the same period in 2020. The increase was primarily due to an increase in personnel costs, manufacturing related expenses and early asset discovery work. Increases were also due to expansion and development of Finchs chronic HBV and ASD programs. -- General and administrative expenses for the second quarter of 2021 were $5.9 million, as compared with $2.6 million for the same period in 2020. The increase was primarily due to increased headcount to support Finchs operational growth, an increase in business insurance costs and an increase in professional fees to support Finchs transition to a public company. -- Finchs cash and cash equivalents as of June 30, 2021 was $168.1 million compared to $99.7 million as of December 31, 2020. Finch expects that the cash and cash equivalents it had on hand at June 30, 2021 will be sufficient to fund operating expenses and capital expenditures into mid-2023.

About Finch Therapeutics

Finch Therapeutics is a clinical-stage microbiome therapeutics company leveraging itsHuman-First Discoveryplatform 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. Finchs lead candidate, CP101, is in late-stage clinical development for the prevention of recurrentC. difficileinfection (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, 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.

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 initiation and timing of Finchs clinical trials and the period during which the results of trials will be available, including specifically the data readouts from a Phase 3 trial in recurrent C. difficile and Phase 1 trials in autism and chronic hepatitis B; Finchs ability to advance the development of a novel class of therapeutics; Finchs ability to demonstrate the breadth and potential of its microbiome therapeutics platform; the therapeutic value, development, and commercial potential of microbiome therapeutics; and Finchs expected cash runway. 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: Finchs limited operating history and historical losses; Finchs ability to raise additional funding to complete the development and any commercialization of its product candidates; Finchs 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 Finchs 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; Finchs product candidates, including CP101, 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; Finchs ability to maintain patent and other intellectual property protection and the possibility that Finchs intellectual property rights may be infringed, invalid or unenforceable or will be threatened by third parties; Finchs ability to qualify and scale its manufacturing capabilities in anticipation of commencement of multiple global clinical trials; Finchs lack of experience in selling, marketing and distributing its product candidates; Finchs 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 Finchs business. These and other risks are described more fully in Finchs filings with the Securities and Exchange Commission (SEC), including the section titled Risk Factors in Finchs Quarterly Report on Form 10-Q filed with the SEC on May 13, 2021, as well as discussions of potential risks, uncertainties, and other important factors in Finchs 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.

Human-First Discovery is a registered trademark of Finch Therapeutics Group, Inc.

Investor Contact:

Laurence WattsGilmartin Group(619) 916-7620laurence@gilmartinir.com

or

Stephen JasperGilmartin Group(858) 525 2047stephen@gilmartinir.com

Media Contact:

Jenna UrbanBerry & Company Public Relationsjurban@berrypr.com212-253-8881

Finch Therapeutics Group, Inc.Condensed Consolidated Statements of Operations (Unaudited)(in thousands, except share and per share data)

FOR THE THREE MONTHS FOR THE SIX MONTHS ENDED JUNE30, ENDED JUNE30, 2021 2020 2021 2020 Revenue: Collaboration $ 2,830 $ 2,237 $ 6,383 $ 3,849 revenueOther revenue ? 112 ? 292 Total revenue 2,830 2,349 6,383 4,141 Operating expenses:Research and 13,964 8,135 26,939 15,532 developmentGeneral and 5,882 2,574 10,433 4,832 administrativeTotal operating 19,846 10,709 37,372 20,364 expensesLoss from (17,016 ) (8,360 ) (30,989 ) (16,223 )operationsOther income 1,847 101 1,839 63 Net loss $ (15,169 ) $ (8,259 ) $ (29,150 ) $ (16,160 )Net loss per shareattributable tocommon $ (0.32 ) $ (1.02 ) $ (0.95 ) $ (2.03 )stockholders?basicand dilutedWeighted-averagecommon stock 47,379,887 8,069,304 30,798,698 7,968,267 outstanding?basicand diluted

Finch Therapeutics Group, Inc.Condensed Consolidated Balance Sheet Data (Unaudited)(in thousands)

JUNE30, DECEMBER31, 2021 2020Assets: Cash and cash equivalents $ 168,136 $ 99,710 Other assets 82,192 65,628 Total assets $ 250,328 $ 165,338 Liabilities, redeemable convertible preferred stock and stockholders' equity (deficit)Liabilities 22,135 28,002 Redeemable convertible preferred stock ? 233,054 Stockholders' equity (deficit) 228,193 (95,718 )Total liabilities, redeemable convertiblepreferred stock and stockholders' equity $ 250,328 $ 165,338 (deficit)