MaaT Pharma Provides Third Quarter 2023 Business Update and Reports Financial Results
November 09 2023 - 12:30PM
Business Wire
- Independent Data Safety Monitoring Board (DSMB) reviewing the
Phase 3 ARES trial evaluating MaaT013 in aGvHD concluded on a
positive benefit/risk ratio based on a good safety profile and
positive preliminary efficacy results with an Overall Response Rate
higher than pre-defined protocol assumptions
- Results from the Company’s Early Access Program of MaaT013 in
111 patients with aGvHD to be presented at the 65th ASH Annual
Meeting
- First patient dosed in the PHOEBUS Phase 2b randomized
placebo-controlled trial evaluating MaaT033 in patients receiving
allo-HSCT
- Preclinical data of MaaT034 presented at the 38th SITC Annual
Meeting
- As of September 30, 2023, cash and cash equivalents were EUR
31.7 million1
- Revenues of EUR 0.4 million in Q3 2023
Regulatory News:
MaaT Pharma (EURONEXT: MAAT – the “Company”), a
clinical-stage biotechnology company and a leader in the
development of Microbiome Ecosystem TherapiesTM (MET) dedicated to
enhancing survival for patients with cancer, today provided a
business update and reported its cash position as of September 30,
2023.
“The positive DSMB review of MaaT013 in its Phase 3 trial and
the commencement of the MaaT033 Phase 2b trial underscores our
leadership position in oncology-focused microbiome therapeutics. It
also demonstrates our ability to execute our clinical plan and
prepare for commercialization through expanded production
capacities that were completed in Q3. We are proud to achieve these
milestones and we will continue to work on generating value for our
shareholders,” stated Siân Crouzet, CFO of MaaT Pharma. “Our
progress and achievements put us in good stead as we look towards
the months ahead and the completion of patient recruitment in the
Phase 3 clinical study in 2024.”
Pipeline highlights
MET-N
MaaT013
- In hemato-oncology:
- In July 2023, the Company announced that clinical data on
MaaT013 as a treatment for aGvHD was published in
eClinicalMedicine, one of the Lancet Discovery Science suite of
journals.
- As a post period event, in October 2023, the Company announced
that the DSMB unanimously recommended that the open-label, single
arm pivotal Phase 3 clinical trial evaluating MaaT013 in acute
Graft-versus-Host Disease (aGvHD), named ARES, can continue without
modification. The Overall Response Rate (ORR) was superior to
pre-defined protocol assumptions. Therefore, the DSMB concluded
that the benefit/risk ratio with “high efficacy and low toxicity”
was favorable in this patient population.
- As a post period event, in November 2023, the Company announced
that extended results from its Early Access Program of MaaT013 in
111 patients (additional 30 patients included in the Program
compared to last year) with aGvHD have been selected for poster
presentations at the 65th American Society of Hematology (ASH)
Annual Meeting.
- In immuno-oncology:
- The Phase 2a PICASSO trial, evaluating MaaT013 in combination
with immune checkpoint inhibitors in metastatic melanoma, is on
schedule, and results should be available in late 2024 or early
2025.
MaaT033
- In hemato-oncology:
- In September 2023, the Company announced that the European
Medicines Agency (EMA) had granted MaaT033 an orphan drug
designation. MaaT033 aims to improve overall survival in patients
undergoing hematopoietic stem cell transplantation (HSCT) and the
EMA had recognized the significant benefit that MaaT033 could
therefore bring to this patient population. The status offers key
benefits including market exclusivity, clinical protocol
assistance, waivers or reductions in regulatory fees.
- As a post period event, in November 2023, the Company announced
that the first patient has been treated as part of its Phase 2b
trial (PHOEBUS) investigating the efficacy of MaaT033 in improving
overall survival at 12 months for patients with blood cancer
receiving allo-HSCT. The international, multi-center, randomized,
double-blind, placebo-control study (NCT05762211), will be
conducted in up to 56 clinical investigation sites and is expected
to enroll 387 patients. It is, to date, the largest randomized
controlled trial assessing a microbiome therapy in oncology.
- As a post period event, in November 2023, the Company announced
that the design of its Phase 2b study evaluating MaaT033 has been
selected for a poster presentation at the 65th American Society of
Hematology (ASH) Annual Meeting.
- In neurodegenerative diseases:
- In September 2023, the Company announced that the first patient
was dosed in the IASO Phase 1b pilot study (NCT05889572) in ALS
(also known as Lou Gehrig's disease in the U.S. and Charcot's
disease in French-speaking countries).
MET-C
MaaT034
- In immuno-oncology:
- As a post period event, in November 2023, the Company had two
presentations at the 38th Society for Immunotherapy of Cancer
(SITC) Annual Meeting including in vitro results for its new
Artificial Intelligence (AI)-generated lead product, MaaT034,
designed to improve responses to immunotherapy for patients with
solid tumors. MaaT034 is the first member of the MET-C platform.
Data presented at SITC 2023 shows that MaaT034 replicates, at large
industrial scale, the richness and diversity of healthy
native-based microbiome ecosystems, restores the integrity of a
damaged gut barrier, activates AhR pathway involved in gut
homeostasis, and stimulates both myeloid and lymphoid immune cells
and improves immune cell response to immune checkpoint inhibitor
(ICI) therapy. The first clinical batches are expected to be
produced in 2024 and the first-in-human testing is planned for
2025.
Corporate update
- In July 2023, MaaT Pharma joined the Microbiome Therapeutics
Innovation Group (MTIG).
- In September 2023, the Company and Skyepharma announced
completion of the cGMP manufacturing facility and the transfer of
MaaT Pharma’s Production and Development teams to the new
site.
Cash position1
- As of September 30, 2023, total cash and cash equivalents were
EUR 31.7 million, as compared to EUR 35.1 million as of June 30,
2023, and EUR 35.2 million as of December 31, 2022. The net
decrease in cash of EUR 3.4 million during the third quarter 2023
reflects continued investment in R&D activities across the
pipeline, offset in part by partial reimbursement of the 2022
R&D tax credit of EUR 0.5 million. The Company believes it has
sufficient cash to cover needs of the development programs into the
second quarter of 2024.
Revenues in Q3 2023
- MaaT Pharma reported revenues from its compassionate access
program of EUR 0.4 million for the quarter ended September 30, 2023
comparable with the third quarter of 2022. Total revenues for the
first three quarters of 2023 amount to EUR 1.8 million compared
with EUR 0.9 million for the first three quarters of 20222. This
trend is a direct reflection of the continued demand from the
medical community for MaaT Pharma’s drug candidate MaaT013.
Upcoming investor and medical conference
participation
- November 14-17, 2023 – London, UK Investor Meetings
- November 14-16, 2023 – Boston, MA – USA, Microbiome
Connect
- November 15-17, 2023 – Lille, France, 22nd Société Francophone
de Greffe de Moelle et de Thérapie Cellulaire (SFGM-TC) Congress -
Booth #12
- December 9-12, 2023 – San Diego, CA – USA, 65th American
Society of Hematology (ASH) Annual Meeting – Posters
presentation
- January 8-12, 2024 – San Francisco, CA – USA, Investor
Meetings
1 Unaudited data
2 The Company would like to correct a clerical error that was
present in its Q2 results press release of July 27, 2023. The
revenue from H1 2022 was EUR 0.5 million, and not EUR 0.9 million
as reported in the press release. The EUR 0.9 million figure was
the difference in revenue between H1 2023 and H1 2022 (EUR 1.4
million vs. EUR 0.5 million).
About MaaT Pharma MaaT Pharma, a clinical-stage
biotechnology company, has established a complete approach to
restoring patient-microbiome symbiosis in oncology. Committed to
treating cancer and graft-versus-host disease (GvHD), a serious
complication of allogeneic stem cell transplantation, MaaT Pharma
has launched, in March 2022, an open-label, single-arm Phase 3
clinical trial in patients with acute GvHD, following the
achievement of its proof of concept in a Phase 2 trial. Its
powerful discovery and analysis platform, gutPrint®, enables the
identification of novel disease targets, evaluation of drug
candidates, and identification of biomarkers for microbiome-related
conditions. The company’s Microbiome Ecosystem Therapies are
produced through a standardized cGMP manufacturing and quality
control process to safely deliver the full diversity of the
microbiome in liquid and oral formulations. MaaT Pharma benefits
from the commitment of world-leading scientists and established
relationships with regulators to support the integration of the use
of microbiome therapies in clinical practice. MaaT Pharma is listed
on Euronext Paris (ticker: MAAT).
Forward-looking Statements All statements other than
statements of historical fact included in this press release about
future events are subject to (i) change without notice and (ii)
factors beyond the Company’s control. These statements may include,
without limitation, any statements preceded by, followed by or
including words such as “target,” “believe,” “expect,” “aim,”
“intend,” “may,” “anticipate,” “estimate,” “plan,” “project,”
“will,” “can have,” “likely,” “should,” “would,” “could” and other
words and terms of similar meaning or the negative thereof.
Forward-looking statements are subject to inherent risks and
uncertainties beyond the Company’s control that could cause the
Company’s actual results or performance to be materially different
from the expected results or performance expressed or implied by
such forward-looking statements.
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version on businesswire.com: https://www.businesswire.com/news/home/20231109022080/en/
MaaT Pharma – Investor Relations Guilhaume DEBROAS, Ph.D. Head
of Investor Relations +33 6 16 48 92 50 invest@maat-pharma.com
MaaT Pharma – Media Relations Pauline RICHAUD Senior PR
& Corporate Communications Manager +33 6 14 06 45 92
media@maat-pharma.com Trophic Communications Jacob VERGHESE or
Priscillia PERRIN +49 151 7441 6179 maat@trophic.eu
Maat Pharma (EU:MAAT)
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