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):
- Update on PRISM4 Phase 3
Trial of CP101 in Recurrent CDI: Today, Finch announced
that it has submitted a complete response to the previously
announced clinical hold related to the investigational new drug
(IND) application for CP101 and requests from the FDA regarding
Finch’s SARS-CoV-2 donor screening protocols and associated
informed consent language. Subsequent to the recent clinical hold
letter, Finch has received additional correspondence from the FDA
requesting changes to the testing algorithm used to diagnose
suspected CDI recurrences in PRISM4, as well as additional
information about the proposed statistical analysis plan for PRISM4
and the validation package for one of Finch’s release tests.
Enrollment in PRISM4 will remain paused until Finch is able to
resolve the clinical hold, address the most recent FDA feedback and
conduct additional manufacturing activities to satisfy requests
related to SARS-CoV-2 donor screening. Finch is evaluating the
extent of the expected delay to the timing for resuming enrollment
in PRISM4 and, based on manufacturing timelines, expects at least a
one quarter delay.
- Clinical Data from PRISM-EXT
and PRISM3 Phase 2 Trials Accepted for Presentation at Digestive
Disease Week (DDW) 2022: Today, Finch announced that data
from its PRISM-EXT Phase 2 open-label trial and its PRISM3 Phase 2
placebo-controlled trial will be presented in May at DDW 2022.
- Reported Positive Topline
Results from PRISM-EXT Phase 2 Open-Label Trial of CP101 in
Recurrent CDI: In November 2021, Finch reported topline
data from PRISM-EXT in which 80.3% and 78.8% of participants who
received CP101 following standard-of-care (SOC) antibiotics were
without CDI recurrence through 8 weeks and 24 weeks post-treatment,
respectively (n=132). There were no treatment-related serious
adverse events (SAEs) reported and CP101 exhibited an overall
safety profile consistent with the profile observed in PRISM3.
- Presented 24-Week Efficacy
and Safety Data from PRISM3 Phase 2 Placebo-Controlled Trial of
CP101 in Recurrent CDI at American College of Gastroenterology
(ACG) Annual Meeting: In October 2021, Finch presented
data from its PRISM3 Phase 2 trial in which 73.5% of participants
who received CP101 following SOC antibiotics (n=102) were without
CDI recurrence through 24 weeks post-treatment, versus 59.4% who
received placebo following SOC antibiotics (n=96) (p=0.0347). There
were no treatment-related SAEs reported in the CP101 arm of the
trial and the rates of adverse events and treatment-related adverse
events were similar in the CP101 and placebo arms through 24 weeks
post-treatment.
Autism Spectrum Disorder (ASD) with Significant
Gastrointestinal (GI) Symptoms:
- Update on AUSPIRE Phase 1b
Trial of FIN-211 in Children with ASD and Significant GI
Symptoms: Finch has determined that the AUSPIRE Phase 1b
trial of FIN-211, a product candidate that includes donor-derived
components, will be delayed in connection with the clinical hold
related to the IND for CP101. To address the FDA’s requests related
to SARS-CoV-2 donor screening protocols, Finch will need to
complete additional manufacturing activities for components of
FIN-211. Finch is evaluating the extent of the expected delay to
the timing of AUSPIRE and, based on manufacturing timelines,
expects at least a one quarter delay.
- Strengthened Patent
Portfolio with Two New U.S. Patents Granted for FIN-211:
In January 2022, Finch announced the issuance of two new U.S.
patents covering its FIN-211 enriched consortia microbiome product
candidate. Finch’s patent portfolio now includes more than 55
issued U.S. and foreign patents with more than 140 patent
applications pending.
Chronic Hepatitis B Virus (HBV) Infection:
- Paused Development of CP101
for Chronic HBV, Focusing Resources on Wholly-Owned CDI and ASD
Programs: Today, Finch announced that it has paused
development of CP101 for the treatment of chronic HBV following a
strategic review of the Company’s pipeline. The Company believes
this decision will allow it to maximize its working capital
available for investment in its wholly-owned recurrent CDI and ASD
programs.
Inflammatory Bowel Disease (IBD):
- Transitioned TAK-524
Ulcerative Colitis Development Program to Takeda for Clinical
Development: In August 2021, Finch announced that Takeda
elected to accelerate the transition of development responsibility
for the TAK-524 ulcerative colitis development program, previously
known as FIN-524, with Takeda to lead further development of the
program. TAK-524, which contains select spore-forming and
non-spore-forming bacterial strains, is the first targeted
consortia product candidate developed with Finch’s machine
learning-based platform.
- Finch and Takeda Continue
FIN-525 Discovery Work Targeting Crohn’s Disease: In
collaboration with Takeda, Finch continues to advance FIN-525
discovery work. FIN-525 is a discovery-stage program aimed at the
development of a targeted consortia product candidate for the
treatment of Crohn’s disease.
Recent Corporate Highlights:
- Retirement
of Chief Financial Officer: Today, Finch announced that
Greg Perry will retire from his position as Chief Financial
Officer, effective April 30, 2022. Following his retirement, Mr.
Perry plans to continue to provide strategic advice to the Company
through the end of 2022 as a consultant. Marc Blaustein, who joined
Finch in September 2021 as Chief Operating Officer (COO), will
serve as the Company's Principal Financial Officer and Principal
Accounting Officer in addition to his role as COO, upon Mr. Perry's
retirement. Mr. Blaustein has more than 20 years of leadership
experience in the biotechnology industry, including significant
experience leading corporate finance initiatives.
- Strengthened
Senior Leadership Team: In February 2022, Finch announced
the appointment of Bryan Gillis, MBA, as its Chief Technology
Officer, Alka Batycky, PhD, as its Chief Development Officer, and
Howard Franklin, MD, MBA, as its Senior Vice President, Late-Stage
Development and GI Therapeutic Area Lead. Additionally, in December
2021, Finch announced the promotion of Joseph Vittiglio, JD, to
Chief Business and Legal Officer.
- Completed Construction of
New Manufacturing Facility: In November 2021, Finch
announced the completion of construction of its new manufacturing
facility designed to support the manufacture of its microbiome
product candidates for clinical trials and to support potential
commercialization needs. Commissioning and qualification activities
are underway for the newly constructed facility.
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 JasperGilmartin
Group(858) 525-2047stephen@gilmartinir.com
Media Contact:Jenna UrbanBerry & Company
Public Relations(212) 253-8881jurban@berrypr.com
Finch Therapeutics Group,
Inc.Condensed Consolidated Statements of
Operations(in thousands, except share and per
share data)
|
|
FOR THE THREE MONTHSENDED
DECEMBER 31, |
|
|
FOR THE YEARENDED
DECEMBER 31, |
|
|
|
2021 |
|
|
2020 |
|
|
2021 |
|
|
2020 |
|
Revenue: |
|
|
|
|
|
|
|
|
|
|
|
|
Collaboration revenue |
|
$ |
806 |
|
|
$ |
1,794 |
|
|
$ |
18,532 |
|
|
$ |
7,376 |
|
Royalty revenue from related
party |
|
|
- |
|
|
|
13 |
|
|
|
- |
|
|
|
343 |
|
Total
revenue |
|
|
806 |
|
|
|
1,807 |
|
|
|
18,532 |
|
|
|
7,719 |
|
Operating
expenses: |
|
|
|
|
|
|
|
|
|
|
|
|
Research and development |
|
|
14,803 |
|
|
|
8,567 |
|
|
|
57,279 |
|
|
|
33,144 |
|
General and administrative |
|
|
5,065 |
|
|
|
6,372 |
|
|
|
21,238 |
|
|
|
14,011 |
|
Total operating
expenses |
|
|
19,868 |
|
|
|
14,939 |
|
|
|
78,517 |
|
|
|
47,155 |
|
Loss from operations |
|
|
(19,062 |
) |
|
|
(13,132 |
) |
|
|
(59,985 |
) |
|
|
(39,436 |
) |
Other income |
|
|
7 |
|
|
|
41 |
|
|
|
1,825 |
|
|
|
95 |
|
Net loss |
|
$ |
(19,055 |
) |
|
$ |
(13,091 |
) |
|
$ |
(58,160 |
) |
|
$ |
(39,341 |
) |
Net loss per share attributable
to common stockholders—basic and diluted |
|
$ |
(0.40 |
) |
|
$ |
(1.56 |
) |
|
$ |
(1.48 |
) |
|
$ |
(4.83 |
) |
Weighted-average common stock
outstanding—basic and diluted |
|
|
47,491,731 |
|
|
|
8,380,808 |
|
|
|
39,202,086 |
|
|
|
8,144,855 |
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
Finch Therapeutics Group,
Inc.Condensed Consolidated Balance Sheet
Data(in thousands)
|
|
DECEMBER 31,2021 |
|
|
DECEMBER 31,2020 |
|
Assets: |
|
|
|
|
|
|
Cash and cash equivalents |
|
$ |
133,481 |
|
|
$ |
99,710 |
|
Other assets |
|
|
91,888 |
|
|
|
65,628 |
|
Total assets |
|
$ |
225,369 |
|
|
$ |
165,338 |
|
Liabilities, redeemable
convertible preferred stock and stockholders' equity
(deficit) |
|
|
|
|
|
|
Liabilities |
|
|
23,145 |
|
|
|
28,002 |
|
Redeemable convertible preferred stock |
|
|
— |
|
|
|
233,054 |
|
Stockholders' equity (deficit) |
|
|
202,224 |
|
|
|
(95,718 |
) |
Total liabilities, redeemable convertible preferred stock and
stockholders' equity (deficit) |
|
$ |
225,369 |
|
|
$ |
165,338 |
|
|
|
|
|
|
|
|
|
|
Finch Therapeutics (NASDAQ:FNCH)
Historical Stock Chart
From Jun 2024 to Jul 2024
Finch Therapeutics (NASDAQ:FNCH)
Historical Stock Chart
From Jul 2023 to Jul 2024