MaaT Pharma Provides Second Quarter 2023 Business Update and Reports Financial Results
2023年7月28日 - 1:00AM
ビジネスワイヤ(英語)
- Data presented at 49th Annual Meeting of EBMT 2023 confirms
clinical benefit of MaaT013 in Acute Graft-versus-Host Disease
(aGvHD) in the early access program
- Clearing of the IND for MaaT013 by the FDA in patients with
aGvHD
- PHOEBUS, a Phase 2b randomized placebo-controlled trial
assessing MaaT033's impact on overall survival in allo-HSCT
patients is now anticipated to start in H2 2023
- As of June 30, 2023, cash and cash equivalents were EUR 35.1
million1
- Revenues of EUR 0.7 million1 in Q2 2023
Regulatory News:
MaaT Pharma (EURONEXT: MAAT – the “Company”), a French
clinical-stage biotech and a pioneer in the development of
Microbiome Ecosystem TherapiesTM (MET) dedicated to improving
survival outcomes for patients with cancer, today provided a
business update and reported its cash position as of June 30, 2023
and its revenues for the second quarter of 2023.
"As a leading microbiome company in oncology, we are proud of
the progress made in the second quarter of 2023. We are
particularly pleased with positive interactions with international
regulatory agencies, such as the FDA's clearance of the IND
application, which paves the way for bringing MaaT013 to patients.
We remain aligned with our strategy to pursue the development of
MaaT013 towards its registration in the treatment of aGvHD.
Additionally, we are on the brink of launching the largest, to our
knowledge, randomized study in hemato-oncology with a microbiome
therapy, as we finalize preparation for the Phase 2 trial of
MaaT033,” commented Hervé Affagard, CEO and co-founder of MaaT
Pharma. “In the upcoming months, we will continue to deliver on the
plans presented during our IPO to investors, patients, and the
global community.”
Pipeline highlights
MaaT013
- In April 2023, MaaT013 clinical results in its early access
program for 81 patients, previously announced at American Society
of Hematology (ASH), were presented during the 49th Annual Meeting
of the European Society for Blood and Marrow Transplantation (EBMT
2023). Clinical results showed a GI-Overall Response Rate (GI-ORR)
of 56% with a 12-month overall survival (OS) of 59% in patients
responding to MaaT013 treatment. A 65% ORR was observed in 31
patients being a similar population to those treated in MaaT
Pharma’s ongoing pivotal Phase 3 ARES clinical trial (3rd-line
therapy after failure to 2nd-line ruxolitinib treatment); 12-month
OS in this group responding to MaaT013 treatment was 74%. As a
reminder, overall survival in ruxolitinib-resistant patients at 2
months is 22% (REACH1 study).
- In April 2023, the U.S. Food and Drug Administration (FDA)
lifted the clinical hold and cleared the Investigational New Drug
(IND) application for MaaT013 in patients with aGvHD. MaaT Pharma
intends to consult with the FDA on the next steps of the regulatory
process to bring MaaT013 to US patients in the most expeditious way
possible while the Company continues the late-stage clinical
development of MaaT013 in Europe with the ongoing international
multicenter, open-label, single arm, pivotal Phase 3 trial
(ARES).
- The Company announces that the independent data safety and
monitoring board (DSMB) meeting, after enrollment of half of the
patients in the ARES study evaluating MaaT013 in aGvHD, is expected
in H2 2023, as opposed to H1 2023, while the ORR is expected
mid-2024.
- In parallel to the ARES trial, the European Early Access
Program (EAP) continues to gather significant interest from
healthcare professionals with the number of patients treated in
H1.2023, significantly higher than that of H1.2022.
- As a post-period event, 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’s journals. The data includes results from 24 patients in a
Phase 2 clinical trial and 52 patients enrolled in the EAP in
France. The article can be accessed here.
- The PICASSO study, sponsored by APHP, is on track for data
readout expected in H2 2024. This is the only double-blind
randomized clinical trial in the field evaluating a microbiome
approach (MaaT013) to enhance the efficacy of immune checkpoints
inhibitors (ICI) treatments in patients with metastatic
melanoma.
- With more than half of the patients now having completed their
week 9 visit, the Company is in a position to receive biological
biomarker data from its partner.
MaaT033
- In April 2023, MaaT033 data of Phase 1b study CIMON, previously
presented at ASH 2022 annual meeting, were also shared at the EBMT
2023. The Company’s second drug candidate was shown to be safe and
tolerable in 21 patients. This is an important milestone prior to
embarking on subsequent clinical development of MaaT033 and for
establishing the dose determination for the Phase 2b PHOEBUS.
- During the period, and following the positive feedback received
from the FDA in April 2023 clearing the IND for MaaT013, the
Company incorporated learnings related to its proprietary pooling
technology into its clinical development plan envisaged for its
second clinical-stage product MaaT033. In parallel, the clinical
protocol of the Phase 2b randomized placebo-controlled PHOEBUS
trial was reviewed in a Scientific Advice with EMA, with a positive
outcome and no consequences on the authorizations already received
in France and Germany in March 2023. Consequently, the start of the
PHOEBUS trial, initially planned to start in Q2 2023 is now
expected in H2 2023. This trial will assess MaaT033's impact on
overall survival in allo-HSCT patients.
- In neurodegenerative diseases:
- The IASO Phase 1b pilot study (NCT05889572) in ALS (also known
as Lou Gehrig's disease in the US and Charcot's disease in
French-speaking country) is active and ready for the first patient
to be dosed.
Corporate update
- On June 19, 2023, all resolutions presented during the AGM were
adopted in line with Board recommendations. For further
information, please visit:
https://www.maatpharma.com/investors/#GM
- In June 2023, MaaT Pharma announced new appointments to the
Board of Directors and Executive team, to align with the Company’s
long-term vision and goals:
- Karim Dabbagh as Chairman and Nadia Kamal as Director, both
independent.
- Pr. Gervais Tougas, acting Chief Medical Officer and Philippe
Moyen, Chief Operating Officer.
- In June 2023, MaaT Pharma announced the appointment of
Guilhaume Debroas as Head of Investor Relations.
- As a post period event, in July 2023, MaaT Pharma announced
having joined the Microbiome Therapeutics Innovation Group (MTIG).
MTIG is a coalition of companies leading the research and
development of FDA-approved microbiome therapeutic drugs and
microbiome-based products to address unmet medical needs, improve
clinical outcomes, and reduce health care costs.
Cash position1
- As of June 30, 2023, total cash and cash equivalents were EUR
35.1 million, as compared to EUR 40.7 million as of March 31, 2023,
and EUR 35.2 million as of December 31, 2022. The net decrease in
cash of EUR 5.6 million during the second quarter 2023 reflecting
the continued investment in R&D activities across the pipeline
and includes partial reimbursement of the 2022 R&D tax credit
for EUR 2.3 million. The Company believes it has sufficient cash to
cover needs of the development programs into the second quarter of
2024.
Revenues in Q2 20231
- MaaT Pharma reported revenues2 from its compassionate access
program of EUR 0.7 million for the quarter ended June 30, 2023,
comparable with EUR 0.7 million for the first quarter of 2023.
Total revenues for the first half of 2023 amount to EUR 1.4 million
compared with EUR 0.9 million for the first half of 2022. This
trend is a direct reflection of the continued demand from the
medical community for drug candidate MaaT013.
Upcoming financial communication and investor conference
participation
- September 26, 2023 – Half-year Results 2023*
- September 27, 2023 – 6th edition - Forum LPB Valeurs
Régionales
- October 4, 2023 – KBC Securities Life Sciences Conference
- October 4-5, 2023 – Portzamparc Seminar Biotech &
Health
- October 9-10, 2023 – Investor Access Event
*Indicative calendar that may be subject to change.
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.
1 Unaudited data
2 Revenues correspond to compensation invoiced in relation to
the compassionate access program, as approved by the French
National Drug Safety Agency (Agence Nationale de Sécurité du
Médicament or ANSM).
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version on businesswire.com: https://www.businesswire.com/news/home/20230727188477/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 – Corporate Communications
Charlotte SPITZ or Stephanie MAY +49 171 351 2733
maat@trophic.eu
Maat Pharma (EU:MAAT)
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Maat Pharma (EU:MAAT)
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から 6 2023 まで 6 2024