MaaT Pharma Publishes its Half Year 2024 Results and Provides a Business Update
-- Positive efficacy and safety data of MaaT013 in aGvHD in the Early Access
Program presented at the EBMT 2024 annual meeting with 63% GI-ORR at D28,
a 49% one year and 42% 18 months Overall Survival (OS) in patients
similar to those included in the ongoing Phase 3 ARES trial.
-- Completion of patients' recruitment for the Phase 2b PICASSO trial
sponsored by AP-HP evaluating MaaT013 in combination with immune
checkpoint inhibitors $(ICI.AU)$ in metastatic melanoma.
-- MaaT013 batches manufactured and ready to be distributed for clinical
supply in the US and in Europe and advancement of the readiness phase for
the initiation of clinical activities.
-- Positive review by an independent Data Safety and Monitoring Board (DSMB)
of the Phase 2b PHOEBUS trial evaluating MaaT033 for patients with blood
cancers undergoing allo-HSCT, which recommended that the trial proceeds
as planned without modification.
-- Successful raise of EUR17.3 million in net proceeds upon completing an
offering in May 2024.
-- As of June 30, 2024, cash and cash equivalents were EUR31.2 million,
anticipated cash runway extended into Q2 2025 after prioritization of
resources around the delivery of Phase 3 topline results for MaaT013 in
Europe.
-- Revenues of EUR1.7 million in H1 2024, compared to EUR1.4 million in H1
2023, linked to a continuous increase in demand for MaaT013 in the Early
Access Program.
LYON, France--(BUSINESS WIRE)--September 19, 2024--
Regulatory News:
MaaT Pharma (EURONEXT: MAAT -- the "Company"), a clinical-stage biotechnology company and a leader in the development of Microbiome Ecosystem Therapies$(TM)$ $(MET)$ dedicated to enhancing survival for patients with cancer through immune modulation, today announced its half year financial results for the six-month period ended June 30, 2024, and provided a business overview.
"Building on the positive data for MaaT013 in April 2024 presented at the EBMT Congress, and the success of our recent fundraising, we have dedicated the first half of 2024 to pursuing recruitment and preparing for the topline results of our ongoing Phase 3 clinical trial for MaaT013. This trial is designed to address the urgent unmet medical need of patients with acute graft-versus-host disease not responding to current treatments. Currently, patients requiring third-line treatment options face an 85% mortality rate within one year. Furthermore, by extending our cash runway by an additional quarter, we are well-positioned to deliver on our short-term milestones," stated Siân Crouzet, Chief Financial Officer of MaaT Pharma.
Pipeline Highlights
MET-N platform
MaaT013
-- In hemato-oncology:
-- In March 2024, the Company announced the launch of a retrospective
multicenter trial called CHRONOS in Europe. Its primary objective
is to provide the Company efficacy data for 3rd-line therapies for
aGvHD patients not receiving MaaT013 or any microbiome
intervention. This retrospective study does not impact cash
projections as funding is already secured.
-- In April 2024, at the 50th Annual Meeting of the European Society
for Blood and Marrow Transplantation $(EBMT)$, the Company presented
promising extended survival data from the Early Access Program in
Europe, involving 140 patients with steroid-refractory $(SR)$ or
steroid-dependent $(SD)$ acute graft-versus-host disease with
gastrointestinal involvement (GI-aGvHD) treated with MaaT013. Data
highlighted a high response rate (Complete Response and Very Good
Partial Response) to MaaT013, demonstrating a clear reduction in
disease burden and improved Overall Survival (OS) at 18 months
compared to published data.
-- In immuno-oncology:
-- In March 2024, the Company informed on the completion of patient
recruitment for the Phase 2a randomized clinical trial
(NCT04988841) (PICASSO) sponsored by AP-HP and in collaboration
with INRAE and Institut Gustave Roussy, evaluating MaaT013 in
combination with immune checkpoint inhibitors (ICI), ipilimumab
(Yervoy$(R)$) and nivolumab (Opdivo(R)), in metastatic melanoma
patients. A total of 70 patients have been enrolled since April
2022. The Company provided its MaaT013 drug candidate and placebo
and will contribute to the microbiome profiling of patients using
its proprietary gutPrint(R) AI research engine. As previously
announced, data readout is expected in Q4 2024/Q1 2025.
MaaT033
-- In hemato-oncology:
-- In May 2024, the Company announced its participation in the
IMMUNOLIFE RHU program, a consortium including academic partners,
such as Institut Gustave Roussy $(IGR)$, a world-renowned center in
the field of cancer treatment, and biotech companies. MaaT033, an
oral, pooled fecal microbiotherapy, developed by MaaT Pharma will
be tested as a concomitant treatment to cemiplimab (Regeneron), an
anti-PD1 therapy, to assess the potential increase in response
rate in patients having received antibiotics. This randomized
multicenter Phase 2 clinical trial will include advanced non-small
cell lung cancer (NSCLC) patients. The related costs for MaaT
Pharma are limited to clinical product supply in line with
previous cash projections. The trial is expected to start in H1
2025.
-- As a post-period event, in July 2024, the Company announced first
DSMB positive review of the Phase 2b trial PHOEBUS and recommended
continuation of the trial without modification. The DSMB concluded
that the safety profile was acceptable and the treatment
well-tolerated. The trial is an international, multi-center,
randomized, double-blind, testing MaaT033, in patient receiving
HSCT, an oral freeze-dried formulation against placebo, set to be
conducted in up to 56 clinical investigation sites and is expected
to enroll 387 patients (NCT05762211).
-- Recruitment for PHOEBUS trial is ongoing in France, Germany, Spain,
and Belgium, with the trial already approved in the Netherlands
and the United Kingdom. Upcoming milestones include a second
safety assessment by the DSMB expected in early Q1 2025. The
interim analysis following the recruitment of 60 patients, is
expected in H1 2025, instead of H2 2024. This slight delay is due
to the strategic option taken by the Company's management in early
2024 to prioritize resources for the Phase 3 ARES trial and open
new trial sites in countries outside France and Germany in a more
sedate manner than originally planned.
-- In neurodegenerative diseases:
-- In February 2024, the Company announced a positive review by the
DSMB on the Phase 1 clinical trial (IASO) evaluating MaaT033 in
Amyotrophic Lateral Sclerosis (ALS) for the first 8 patients. The
DSMB recommended that the trial proceed without modification.
-- In May 2024, the Company announced the completion of patient
recruitment for IASO.
MET-C platform
MaaT034
-- In combination with immune checkpoint inhibitors in solid tumors
-- In April 2024, the Company presented new in vitro data
characterizing the metabolites produced by MaaT034 and their
impact on immune modulation at the American Association for Cancer
Research (AACR) Annual Meeting 2024 in San Diego, California.
MaaT034, the first product from MaaT Pharma's MET-C platform, is a
ground-breaking full ecosystem synthetic microbiota product being
developed for patients with solid tumors to improve responses to
immunotherapy in combination with an ICI treatment, which
represents a potentially large market. In today's challenging
economic environment, the Company has prioritized resources to
focus on MaaT013, specifically preparing marketing authorization
activities in Europe and the upcoming Phase 3 topline results in
Europe. This approach aimed at optimizing both short-term
validation and clinical validation, has resulted in a deferral of
activities related to MaaT034. Thus, clinical activities for
MaaT034 are now expected to begin in 2026 and not 2025, as
previously announced.
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