UNITED STATES
SECURITIES AND EXCHANGE COMMISSION
WASHINGTON, D.C. 20549
FORM
CURRENT REPORT
Pursuant to Section 13 or 15(d) of the Securities Exchange Act of 1934
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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:
Securities registered pursuant to Section 12(b) of the Act:
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Trading |
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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.
On March 31, 2022, Finch Therapeutics Group, Inc. (the “Company”) issued a press release announcing its recent business highlights and financial results for the quarter and year ended December 31, 2021. A copy of the press release is furnished as Exhibit 99.1 to this Current Report on Form 8-K and is incorporated herein by reference.
The information contained in Item 2.02 of this Current Report on Form 8-K, including Exhibit 99.1 attached hereto, is being furnished and shall not be deemed “filed” for purposes of Section 18 of the Securities and Exchange Act of 1934, as amended (the “Exchange Act”), and shall not be deemed incorporated by reference in any filing under the Securities Act of 1933, as amended, or the Exchange Act, except as expressly set forth by specific reference in such filing.
Item 9.01 Financial Statements and Exhibits.
(d) Exhibits
Exhibit Number |
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Description |
99.1 |
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104 |
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Cover Page Interactive Data File (embedded within the Inline XBRL document) |
SIGNATURES
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 thereunto duly authorized.
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FINCH THERAPEUTICS GROUP, INC. |
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Date: |
March 31, 2022 |
By: |
/s/ Mark Smith |
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Mark Smith, Ph.D. |
Exhibit 99.1
Finch Therapeutics Reports Fourth Quarter and Full Year 2021 Financial Results and Provides Business Updates
SOMERVILLE, Mass., March 31, 2022 (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 fourth quarter and full year 2021 financial results and provided business updates.
“Finch achieved many significant milestones in 2021, including new clinical data readouts that support our lead product candidate, CP101, for the prevention of recurrent C. difficile infection and the advancement of our TAK-524 ulcerative colitis development program to Takeda for further development. Following a strategic review of our pipeline, we have decided to focus on our C. difficile and autism programs, in addition to our partnership with Takeda focused on inflammatory bowel disease, and we have paused development of CP101 for the treatment of chronic hepatitis B infection, preserving capital for our prioritized programs,” said Mark Smith, PhD, Chief Executive Officer of Finch Therapeutics. “With regards to PRISM4, our Phase 3 trial of CP101 in recurrent C. difficile, we have been in communication with the FDA and recently submitted a complete response to the clinical hold related to our IND for CP101 and our SARS-CoV-2 donor screening protocols and we look forward to working closely with the FDA to address their recent requests.”
“Today, we are also announcing the upcoming retirement of Greg Perry, our Chief Financial Officer, who has been an incredible partner to Finch over the past several years and played an instrumental role in our growth from an early-stage private company to a public company with multiple development programs,” added Dr. Smith. “On behalf of our entire team, I want to thank Greg for his many contributions and wish him the best as he heads into his retirement. Greg’s team will be in good hands, with Marc Blaustein, our current Chief Operating Officer, expanding his responsibilities to include leadership of our finance organization.”
Recent Program Highlights
Recurrent C. difficile Infection (CDI):
Autism Spectrum Disorder (ASD) with Significant Gastrointestinal (GI) Symptoms:
Chronic Hepatitis B Virus (HBV) Infection:
Inflammatory Bowel Disease (IBD):
Recent Corporate Highlights:
Financial Results:
Finch reported a net loss of $19.1 million for the fourth quarter of 2021, compared to a net loss of $13.1 million for the same period in 2020. Finch reported a net loss of $58.2 million for the full year of 2021, compared to a net loss of $39.3 million for the prior year.
Research and development (R&D) expenses were $14.8 million for the fourth quarter of 2021, compared to $8.6 million for the same period in 2020. R&D expenses were $57.3 million for fiscal year 2021, compared to $33.1 million for the prior year. The increases were primarily due to an increase in personnel costs, manufacturing related expenses and platform related costs, as Finch continues to build its platform and prepare for the future development of commercial supply needs.
General and administrative (G&A) expenses were $5.1 million for the fourth quarter of 2021, compared to $6.4 million for the same period in 2020. The decrease in G&A expense quarter-over-quarter was primarily due to a decrease in stock-based compensation expense resulting from the sale of common stock in the fourth quarter of 2020 by certain executives. No similar expense was recorded in 2021. This decrease was offset by an increase in salaries and related personnel costs in the fourth quarter of 2021 to support Finch’s operational growth. G&A expenses were $21.2 million for fiscal year 2021, compared to $14.0 million for the prior year. The year-over-year increase is primarily related to an increase in headcount to support Finch’s operational growth, directors and officers insurance expense and costs associated with Finch’s transition to a public company in March 2021.
Finch’s cash and cash equivalents as of December 31, 2021 was $133.5 million, compared to $99.7 million as of December 31, 2020. Finch expects that the cash and cash equivalents it had on hand as of
December 31, 2021 will be sufficient to fund its operating expenses and capital expenditures into mid-2023.
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. 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.
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 timing and the resolution of the FDA clinical hold related to Finch’s SARS-CoV-2 donor screening protocols and informed consent process and the impact of the clinical hold on Finch’s clinical and pre-clinical programs; the structure, timing and planned milestones of Finch’s clinical trials, including specifically PRISM4, Finch’s Phase 3 clinical trial in CDI, and AUSPIRE, Finch’s Phase 1 trial in ASD; Finch’s ability to advance the development of a novel class of therapeutics; increased efficiencies as a result of Finch's strategic refocus; and Finch's anticipated 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: the risk that Finch may not be able to address the FDA’s concerns regarding SARS-CoV-2 testing protocols and informed consent quickly or at all; uncertainties relating to regulatory applications and related filing and approval timelines, including the risk that FDA may not remove the clinical hold; 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 Quarterly Report on Form 10-Q filed with the SEC on November 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:
Stephen Jasper
Gilmartin Group
(858) 525-2047
stephen@gilmartinir.com
Media Contact:
Jenna Urban
Berry & Company Public Relations
(212) 253-8881
jurban@berrypr.com
Finch Therapeutics Group, Inc.
Condensed Consolidated Statements of Operations
(in thousands, except share and per share data)
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FOR THE THREE MONTHS |
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FOR THE YEAR |
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2021 |
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2020 |
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2021 |
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2020 |
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Revenue: |
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Collaboration revenue |
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$ |
806 |
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$ |
1,794 |
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$ |
18,532 |
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$ |
7,376 |
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Royalty revenue from related party |
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- |
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13 |
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- |
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343 |
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Total revenue |
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806 |
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1,807 |
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18,532 |
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7,719 |
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Operating expenses: |
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Research and development |
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14,803 |
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8,567 |
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57,279 |
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33,144 |
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General and administrative |
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5,065 |
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6,372 |
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21,238 |
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14,011 |
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Total operating expenses |
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19,868 |
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14,939 |
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78,517 |
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47,155 |
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Loss from operations |
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(19,062 |
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(13,132 |
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(59,985 |
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(39,436 |
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Other income |
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7 |
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41 |
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1,825 |
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95 |
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Net loss |
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$ |
(19,055 |
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$ |
(13,091 |
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$ |
(58,160 |
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$ |
(39,341 |
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Net loss per share attributable to common stockholders—basic and diluted |
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$ |
(0.40 |
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$ |
(1.56 |
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$ |
(1.48 |
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$ |
(4.83 |
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Weighted-average common stock outstanding—basic and diluted |
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47,491,731 |
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8,380,808 |
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39,202,086 |
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8,144,855 |
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Finch Therapeutics Group, Inc.
Condensed Consolidated Balance Sheet Data
(in thousands)
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DECEMBER 31, |
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DECEMBER 31, |
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Assets: |
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Cash and cash equivalents |
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$ |
133,481 |
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$ |
99,710 |
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Other assets |
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91,888 |
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65,628 |
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Total assets |
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$ |
225,369 |
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$ |
165,338 |
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Liabilities, redeemable convertible preferred stock and stockholders' equity (deficit) |
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Liabilities |
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23,145 |
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28,002 |
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Redeemable convertible preferred stock |
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— |
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233,054 |
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Stockholders' equity (deficit) |
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202,224 |
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(95,718 |
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Total liabilities, redeemable convertible preferred stock and stockholders' equity (deficit) |
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$ |
225,369 |
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$ |
165,338 |
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