Finch Therapeutics Provides Corporate Update and Reports First Quarter 2022 Financial Results
16 Maggio 2022 - 1:00PM
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 provided a
corporate update and reported financial results for the first
quarter ended March 31, 2022.
“Finch made several important strides this quarter, including
the resolution of the FDA clinical hold previously placed on our
IND for CP101. We are pleased to have addressed the FDA’s questions
related to our SARS-CoV-2 screening procedures and look forward to
completing the additional activities that we believe will enable us
to proceed with enrollment in PRISM4, our Phase 3 trial of CP101 in
recurrent C. difficile infection,” said Mark Smith, PhD, Chief
Executive Officer of Finch Therapeutics. “We are also preparing to
advance FIN-211 into the clinic, which is our investigational
microbiome therapeutic in development for children with autism and
significant GI symptoms. We recently made several modifications to
the design of AUSPIRE, our Phase 1b trial of FIN-211, such as the
addition of a placebo arm which we believe will enable us to draw
more meaningful insights into the potential impact of FIN-211 on
behavioral and GI symptoms.”
Dr. Smith continued, “With our recent decision to prioritize our
C. difficile and autism programs, in addition to our
Takeda-partnered work in inflammatory bowel disease, and the recent
debt financing with Hercules Capital, we believe that we are well
positioned to execute upon our mission and strategic priorities,
with expected cash runway through key clinical milestones,
including topline data from PRISM4 and initial safety data from
AUSPIRE.”
Recent Program Highlights
CP101 for the Prevention of Recurrent C. difficile
Infection (CDI):
- FDA Removed Clinical Hold on CP101 IND: In
April 2022, Finch announced that the U.S. Food and Drug
Administration (FDA) removed the clinical hold on its
investigational new drug (IND) application for CP101 following a
review of information Finch provided related to its SARS-CoV-2
screening procedures and associated informed consent language. As
previously announced, Finch expects to proceed with enrollment in
PRISM4 after the Company completes certain manufacturing activities
and quality system updates related to the recently resolved
clinical hold, and submits for the FDA’s review and agreement the
validation package for one of its release tests and a PRISM4
protocol amendment. The protocol amendment will implement changes
to the algorithm used to diagnose suspected CDI recurrences and
revisions to the planned statistical analysis.
- Updated Timeline for PRISM4 Phase 3 Trial of CP101 in
Recurrent CDI: Finch expects to proceed with enrollment in
PRISM4 in H2 2022 and plans to provide further guidance on the
expected timing of a topline PRISM4 data readout in the
future.
- Clinical Data from PRISM-EXT and PRISM3 Phase 2 Trials
Accepted for Presentation at Digestive Disease Week (DDW)
2022: In March 2022, 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. The
topline data presented at DDW will be available in the
“Publications” section of the Finch website after the meeting.
FIN-211 for Autism Spectrum Disorder (ASD) with
Significant Gastrointestinal (GI) Symptoms:
- Update on FIN-211 Development Timeline: Finch
anticipates submitting the IND for FIN-211 in Q4 2022. The IND
submission is expected to reflect recent enhancements to the design
of the AUSPIRE Phase 1b trial of FIN-211 and manufacturing updates
related to the recently resolved clinical hold on the IND for
CP101. Finch plans to provide guidance in the future on the
expected timing of a topline AUSPIRE data readout.
- Enhanced AUSPIRE Phase 1b Trial Design, Including the
Addition of a Placebo Arm: In the new AUSPIRE trial
design, Finch plans to randomize approximately 36 participants to
receive FIN-211 or placebo daily for 8 weeks, with the addition of
a placebo arm expected to provide greater insights into the
therapeutic potential of FIN-211. The primary endpoint of the trial
will be safety and tolerability, with secondary endpoints including
behavioral and GI symptom assessment. Exploratory endpoints will
include additional behavioral and GI endpoints, as well as
pharmacokinetic and pharmacodynamic assessments.
Recent Corporate Updates
- Secured $55 Million Term Debt Facility from Hercules
Capital, Inc. (NYSE: HTGC): Under the terms of the debt
facility with Hercules Capital, $15 million was drawn at closing,
two tranches of $10 million are each available at Finch’s
discretion, and an additional $20 million is available upon
achievement of a milestone linked to topline data from
PRISM4.
- Appointed Susan E. Graf as Chair of Board of Directors
(Board): In April 2022, Finch announced that Susan E.
Graf, who joined Finch’s Board in April 2021, will serve as Chair
of its Board of Directors. Ms. Graf brings more than 25 years of
leadership experience in the life sciences industry, including
previously serving as the Chief Executive Officer of Akamara
Therapeutics, Inc. and the Chief Business Officer and Principal
Financial Officer at Epizyme, Inc.
- Appointed Howard Franklin, MD, as Interim Chief Medical
Officer (CMO): Finch has appointed Howard Franklin, MD, as
Interim CMO. Dr. Franklin, who served as CMO at Salix
Pharmaceuticals, Inc. prior to joining Finch, has more than 20
years of experience as a general surgeon and biopharmaceutical
executive, with deep expertise spanning clinical development,
regulatory strategy, medical affairs, and product
commercialization.
- Restructured Workforce to Focus Resources on Key
Development Programs: In April 2022, Finch announced plans
to reduce its workforce by approximately 20%. This workforce
reduction is intended to allow the company to focus its financial
resources on its recurrent CDI and ASD development programs, two
wholly-owned programs that Finch is prioritizing, along with its
Takeda-partnered work in inflammatory bowel disease (IBD).
Corporate Update Conference Call and
Webcast
Finch management will host a conference call and live webcast on
Monday, May 16, 2022, at 8:00 am ET to discuss updates to its
development programs and other business highlights. The conference
call can be accessed by dialing (833) 649-1186 (domestic) or (270)
823-1080 (international) and entering conference ID 8451806. The
live webcast can be accessed by visiting the “Investors & News”
section of the Finch website and selecting “Events &
Presentations.” The webcast will be archived on the website for
approximately 30 days following the event.
First Quarter 2022 Financial Results
- Finch reported a net loss of $24.6 million for the first
quarter of 2022, compared to a net loss of $14.0 million for the
same period in 2021. The net loss was driven by an increase in
operating expenses of $7.4 million compared to the first quarter of
2021, in addition to a decrease in revenue of $3.2 million,
primarily due to the November 2021 amendment to the agreement with
Takeda, pursuant to which we transitioned primary responsibilities
for TAK-524 to Takeda in the third quarter of 2021, resulting in a
decrease in collaboration revenue in the current quarter.
- Research and development expenses were $15.5 million for the
first quarter of 2022, compared to $13.0 million for the same
period in 2021. The increase was 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. The increase
was partially offset by a decrease in IBD program expenses due to
the transition of primary responsibilities for TAK-524 from Finch
to Takeda in the third quarter of 2021.
- General and administrative expenses were $9.4 million for the
first quarter of 2022, compared to $4.6 million for the same period
in 2021. The increase was primarily due to an increase in personnel
costs including stock-based compensation, an increase in directors
and officers insurance expense, and an increase in legal and
professional costs, including costs associated with being a public
company.
- Finch’s cash and cash equivalents as of March 31, 2022 was
$106.9 million, compared to $133.5 million as of December 31, 2021.
Finch believes its cash and cash equivalents on hand as of March
31, 2022, together with anticipated, non-dilutive sources of
additional cash, will fund its operations into Q2 2024. These
anticipated sources of cash include $15 million of funding that has
now been drawn under the recent debt facility with Hercules
Capital, a $10 million tranche of funding that is available at
Finch’s discretion under this debt facility, expected near term
milestones from the Takeda partnership, and the expected subletting
of one of Finch’s office and lab facilities.
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 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. We routinely post information that may
be important to our investors on our website at
www.finchtherapeutics.com. The Company encourages investors to
consult the “Investors & News” section of its website
regularly.
Human-First Discovery® is a registered trademark of Finch
Therapeutics Group, Inc.
Forward-Looking Statements
This press release includes “forward-looking statements.” Words
such as “will,” "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: Finch’s ability to execute upon its mission
and strategic priorities; Finch’s ability to complete additional
activities that it believes will enable it to proceed with
enrollment in PRISM4 and the anticipated timeline for results from
the trial; the design of Finch’s AUSPIRE trial, Finch’s plans to
advance FIN-211 into the clinic and the anticipated timeline for
submitting an IND for FIN-211; the potential for the modifications
to the AUSPIRE trial design to enable the company to draw more
meaningful insights into the potential impact of FIN-211 on
behavioral and GI symptoms; the workforce reduction and Finch’s
ability to focus its financial resources on its existing
development programs; Finch’s ability to build its platform and
plan for its future development of commercial supply needs; and
Finch's anticipated runway, including accessing additional sources
of capital. 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
correspondence from the FDA may require Finch to collect additional
data or information beyond what it currently expects, as well as
unexpected regulatory actions or delays, including requests for
additional safety and/or efficacy data or analysis of data, or
government regulation generally; uncertainties relating to
regulatory applications and related filing and approval timelines;
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 Annual Report on Form 10-K for the year ended
December 31, 2021 filed with the SEC on March 31, 2022, 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 (Unaudited)(in thousands, except share
and per share data)
|
|
FOR THE THREE MONTHS ENDED MARCH 31, |
|
|
|
2022 |
|
|
2021 |
|
Revenue: |
|
|
|
|
|
|
Collaboration revenue |
|
$ |
354 |
|
|
$ |
3,553 |
|
Total
revenue |
|
|
354 |
|
|
|
3,553 |
|
Operating
expenses: |
|
|
|
|
|
|
Research and development |
|
|
15,530 |
|
|
|
12,975 |
|
General and administrative |
|
|
9,404 |
|
|
|
4,552 |
|
Total operating
expenses |
|
|
24,934 |
|
|
|
17,527 |
|
Loss from operations |
|
|
(24,580 |
) |
|
|
(13,974 |
) |
Other income (expense) |
|
|
13 |
|
|
|
(7 |
) |
Net loss |
|
$ |
(24,567 |
) |
|
$ |
(13,981 |
) |
Net loss per share attributable
to common stockholders—basic and diluted |
|
$ |
(0.52 |
) |
|
$ |
(1.00 |
) |
Weighted-average common stock
outstanding—basic and diluted |
|
|
47,528,948 |
|
|
|
14,033,273 |
|
Finch Therapeutics Group,
Inc.Condensed Consolidated Balance Sheet Data
(Unaudited)(in thousands)
|
|
MARCH 31, 2022 |
|
|
DECEMBER 31, 2021 |
|
Assets: |
|
|
|
|
|
|
Cash and cash equivalents |
|
$ |
106,931 |
|
|
$ |
133,481 |
|
Other assets |
|
|
97,702 |
|
|
|
91,888 |
|
Total assets |
|
$ |
204,633 |
|
|
$ |
225,369 |
|
Liabilities, redeemable
convertible preferred stock and stockholders' equity |
|
|
|
|
|
|
Liabilities |
|
|
24,842 |
|
|
|
23,145 |
|
Stockholders' equity |
|
|
179,791 |
|
|
|
202,224 |
|
Total liabilities, redeemable convertible preferred stock and
stockholders' equity |
|
$ |
204,633 |
|
|
$ |
225,369 |
|
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