Finch Therapeutics Reports Third Quarter 2021 Financial Results and Provides Business Updates
November 10 2021 - 7:05AM
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
- Reported Positive Topline Results from PRISM-EXT Phase
2 Trial of CP101 in Recurrent CDI: In November 2021, Finch
reported positive topline results from PRISM-EXT, a Phase 2
open-label trial evaluating CP101 for the prevention of recurrent
CDI. Of the 132 participants who received CP101 following
standard-of-care antibiotics, 80.3% and 78.8% of participants
achieved sustained clinical cure through 8 weeks and 24 weeks
post-treatment, respectively. There were no treatment-related
serious adverse events reported and CP101 exhibited an overall
safety profile consistent with the profile observed in PRISM3. The
PRISM-EXT results are consistent with and build on the previously
reported PRISM3 Phase 2 trial results, which showed that CP101 met
its primary efficacy endpoint with a statistically significant
improvement in the prevention of recurrent CDI compared to placebo
through 8 weeks post-treatment. Across PRISM-EXT and PRISM3, 234
doses of CP101 have been administered to 214 participants, which we
believe is the largest clinical dataset reported to date for an
orally administered investigational microbiome therapeutic.
- Initiated Enrollment in PRISM4 Phase 3 Trial of CP101
in Recurrent CDI: In November 2021, Finch announced the
start of enrollment in PRISM4, a Phase 3 randomized,
placebo-controlled trial that is expected to enroll approximately
300 participants with recurrent CDI. PRISM4 is designed to serve as
the second pivotal trial of CP101 for the prevention of recurrent
CDI.
- Presented Additional Positive Data from PRISM3 Phase 2
Placebo-Controlled Trial of CP101 in Recurrent CDI at American
College of Gastroenterology (ACG) Annual Meeting: Data
presented at ACG in October 2021 from the PRISM3 Phase 2 trial
showed that CP101 demonstrated statistically significant
improvement in the prevention of recurrent CDI compared to placebo
and a safety profile similar to placebo through 24 weeks
post-treatment.
- Completed Construction of New Manufacturing
Facility: Finch recently completed the construction of its
new manufacturing facility designed to support the manufacture of
its microbiome product candidates for clinical trials and potential
commercialization. Commissioning and qualification activities are
underway for the newly constructed facility.
- AUSPIRE Phase 1b Trial of FIN-211 in Children with
Autism Spectrum Disorder (ASD) and Gastrointestinal Symptoms
Expanded to Include a Second Cohort: The AUSPIRE Phase 1b
trial of FIN-211 in children with ASD and gastrointestinal (GI)
symptoms will include a dose escalation portion (Part A) and a
recently added expansion cohort (Part B). In Part A, two weeks of a
low and high dose of FIN-211 will be evaluated in trial
participants. In Part B, eight weeks of the highest tolerated
FIN-211 dose from Part A will be evaluated in two groups, one that
will receive vancomycin pre-treatment and one without vancomycin
pre-treatment.
- Takeda Accelerated Leadership Role in TAK-524 (formerly
FIN-524) Ulcerative Colitis (UC) Development Program: In
August 2021, Finch announced that Takeda elected to accelerate the
transition of development responsibility for TAK-524, a targeted
consortia microbiome product candidate developed by Finch and
Takeda for the treatment of UC. The transition will enable Takeda
to leverage its expertise in inflammatory bowel disease throughout
the clinical development of TAK-524.
Leadership Updates:
- Transition of Chief Medical Officer (CMO): In
November 2021, Finch announced that Zain Kassam, MD, MPH elected to
step down as CMO in order to return to Canada to attend to a family
health matter. Dr. Kassam will continue to support Finch as a
special advisor. Debra Silberg, MD, PhD, an accomplished
gastroenterologist and pharmaceutical executive with 18 years of
experience in clinical development, will serve as Finch’s interim
CMO and support the company through the transition and search for a
new CMO.
- Expanded Board of Directors: In October 2021,
Finch appointed Samuel Allen (Al) Hamood to its Board of Directors.
Mr. Hamood is an accomplished executive with over 30 years of
experience in finance, business development, corporate strategy,
and M&A across several global industry sectors.
- Strengthened Executive Leadership Team: In
September 2021, Finch appointed Marc Blaustein as Chief Operating
Officer. Mr. Blaustein is a seasoned biopharmaceutical executive
with more than 20 years of experience building and leading
companies and critical business functions including operations,
business development, program management, and manufacturing.
Key Anticipated Milestones
- Initiation of AUSPIRE Phase 1b trial of FIN-211 in children
with ASD and GI symptoms anticipated in the first half of 2022,
with an interim readout expected from the dose escalation portion
of the trial in the second half of 2022 and topline data from the
expansion cohort expected in 2023.
- Initiation of RECLAIM Phase 1b trial of CP101 in chronic HBV
infection anticipated in early 2022, with topline data from an
initial cohort expected in the second half of 2022.
- Topline data readout from PRISM4 Phase 3 trial of CP101 in
recurrent CDI expected in the first half of 2023.
Third Quarter 2021 Financial
Results
- Finch reported a net loss of $10.0 million for the third
quarter of 2021 as compared to a net loss of $10.1 million for the
same period in 2020. The net loss was driven by an increase in
research and development expenses, as well as increased costs
related to the infrastructure needed to support Finch’s growth,
which was offset by collaboration revenue earned through our
agreement with Takeda.
- Research and development expenses for the third quarter of 2021
were $15.5 million compared with $9.0 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
Finch’s chronic HBV and ASD programs.
- General and administrative expenses for the third quarter of
2021 were $5.7 million, as compared with $2.8 million for the same
period in 2020. The increase was primarily due to increased
headcount to support Finch’s operational growth, an increase in
business insurance costs and an increase in professional fees to
support Finch’s transition to a public company.
- Finch’s cash and cash equivalents as of September 30, 2021 was
$149.2 million compared to $99.7 million as of December 31, 2020.
Finch expects that the cash and cash equivalents it had on hand at
September 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 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 laurence@gilmartinir.com
or
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
(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 |
|
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