- The ARES study on MaaT013 reached the required patient
threshold for DSMB1 planning in early Q4.23
- The European Medicines Agency (EMA) has granted MaaT033 orphan
drug designation aiming to improve overall survival in patients
undergoing HSCT2
- First patient was dosed in the IASO Phase 1b pilot study in
Amyotrophic Lateral Sclerosis (ALS) with MaaT033
- Completion within 12 months of the manufacturing facility in
partnership with Skyepharma and transfer of MaaT Pharma’s
Production and Development capabilities to the new 17,200 sq ft
site
- As of June 30, 2023, cash and cash equivalents were €35.1
million, anticipated cash runway into Q2 2024
- Revenues of €1.4 million in H1 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 announced
its half year financial results for the six-month period ended June
30, 2023 and provided a business overview.
“Over the first half of 2023, we laid a solid foundation for
clinical development and manufacturing scale-up. Regarding MaaT013,
our onco-hematology lead product, the lifting of the FDA hold and
the upcoming DSMB review for our Phase 3 trial represent pivotal
moments in our development. In addition, our second asset, MaaT033,
has received orphan drug designation from the EMA, highlighting the
pressing medical need for improved treatments in HSCT. Achieving
these significant milestones reflects MaaT Pharma's unwavering
commitment to progress and innovation.” stated Siân Crouzet,
Chief Financial Officer of MaaT Pharma. "These achievements
also contribute to the overall positive trends in the global
microbiome landscape, as demonstrated by the industry’s latest
positive clinical data and the recent approval of the third
microbiome drug by regulatory agencies.”
Pipeline Highlights
MET-N platform
MaaT013
- In onco-hematology:
- In April 2023, MaaT013 clinical results in its early access
program for 81 patients, previously communicated during the 64th
annual meeting of the American Society of Hematology (ASH), were
presented during the 49th Annual Meeting of the European Society
for Blood and Marrow Transplantation (EBMT 2023).
- 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 aGvHD3. 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).
- 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.
- As a post period event, the Company announces that the ARES
study has recruited the required number of patients and that the
DSMB is planned for early Q4.23.
- In immuno-oncology:
- The PICASSO study, sponsored by APHP, is largely on track for
data readout now expected by end of 2024/early 2025. 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 biomarker
data from its partner.
MaaT033
- In onco-hematology:
- In April 2023, MaaT033 data of Phase 1b study CIMON, previously
communicated during the 64th annual ASH meeting, were also
presented at the EBMT 2023.
- As a post period event, in September 2023, the Company
announced that the European Medicines Agency (EMA) had granted
MaaT033 orphan drug designation aiming to improve overall survival
in patients undergoing HSCT and had recognized the significant
benefit that MaaT033 could therefore bring to this patient’s
population. The status offers key benefits including market
exclusivity, clinical protocol assistance, waivers or reductions in
regulatory fees.
- In neurodegenerative diseases:
- As a post period event, the Company announces 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 US and Charcot's
disease in French-speaking countries). The Company has developed
the clinical trial in partnership with the French patients’
association Tous en Selles contre la SLA.
MET-C platform
MaaT034
- In combination with immune checkpoint inhibitors in solid
tumors
- MaaT034 is the first member of the MaaT03X co-culture family
from the MET-C platform. First in human is scheduled for 2025, with
the manufacture of the first clinical batch in 2024.
- As a post period event, the Company announces that two posters
have been accepted for the 38th Annual Meeting of Society for
Immunotherapy of Cancer (SITC), Nov 1-5, 2023 in San Diego, CA
USA.
Corporate update
- In February 2023, the Company announced the successful
completion of a capital increase of approximately €12.7 million
supported by its existing shareholders including Seventure
Partners, PSIM Fund represented by Bpifrance Investissement,
Biocodex, Invus, Céleste Management, Skyviews Life Sciences and
Tocqueville.
- 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.
- Philippe Moyen as Chief Operating Officer.
- In June 2023, MaaT Pharma also announced the appointment of
Guilhaume Debroas as Head of Investor Relations.
- As a post period event, in July 2023, MaaT Pharma announced
joining the Microbiome Therapeutics Innovation Group (MTIG).
- As a post period event, 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.
- As a post period event and with deep sorrow, MaaT Pharma
announces the sudden passing of Professor Gervais Tougas, who
served as our part time acting Chief Medical Officer. The Company
has initiated a search for a full-time replacement.
Key Financial Results
The key unaudited financial results for the first half of 2023
are as follows:
Income Statement
In thousands of euros
2023.06
2022.06
Revenue
1 378
494
Cost of Goods Sold
(284 )
(72 )
Gross Margin
1 095
422
Other Income
2 659
1 793
Sales and distribution costs
(541 )
(140 )
General and administrative costs
(2 097 )
(2 115 )
Research and development costs
(9 650 )
(7 328 )
Operating Income (loss)
(8 534 )
(7 368 )
Financial Income
258
-
Financial Expense
(159 )
(50 )
Net financial income (expense)
99
(49 )
Income (loss) before income tax
(8 435 )
(7 417 )
Income tax expense
-
-
Net Income (loss) for the
period
(8 435 )
(7 417 )
Prepared in accordance with international standards, IFRS
Revenues totaled €1.4 million for the half year ended June 30,
2023, compared with €0.5 million in the half year ended June 30,
2022, reflecting the increase in demand from healthcare
professionals and the treatment of an increased number of
patients.
Operating loss amounted to €8.5 million in the first half of
2023 compared with €7.4 million in the first half of 2022, an
increase of €1.2 million. This increase reflects the growth of
research and development costs which have risen from €7.3 million
in the first half of 2022 to €9.7 million in 2023, representing an
overall increase of €2.3 million and fully consistent with the
advancement of the Company’s research programs, offset in part by
the R&D tax credit of €2.7 million included in “Other
Income”.
The net loss amounts to €8.4 million as of June 30, 2023,
compared with €7.4 million as of June 30, 2022, reflecting the
growth of the Company and in particular the investment in
R&D.
The average number of employees has increased from 39 over the
first half of 2022 to 47 for the same period of 2023. As of June
30, 2023, there were 51 employees, of which 39 were dedicated to
research and development.
Cash Position
As of June 30, 2023, total cash and cash equivalents were €35.1
million, as compared to €35.2 million as of December 31, 2022.
Over the first half of 2023, the net decrease in cash position
amounted to €0.2 million compared with €4.9 million in the first
half of 2022. Nonetheless, cash used to finance operations
increased by €5.9 million for compared with the first half of 2022
due to the increased in operating expenses, particularly associated
with research and development. Cash inflows related to financing
activities amounted to €13.2 million as a result of the capital
increase of approximately €12.7 million supported by its existing
shareholders in February 2023, in addition to financing of the 2022
R&D tax credit for a total of €3.1 million offset by loan
repayments totaling €1.5 million.
Total financial debt (including lease liabilities) totaled €13.0
million as of June 30, 2023, of which €0.6 million relates to
state-backed loans (“PGE”).
Based on the development plans and corresponding cash needs, the
Company believes it has sufficient cash to finance its activities
into the second quarter of 2024.
The Company has updated its corporate presentation, which can be
downloaded here: https://www.maatpharma.com/investors/
Upcoming financial communication*
- November 9, 2023 – Q3 2023 Results
*Indicative calendar that may be subject to change.
Upcoming investor and scientific conferences
participation
- 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
- November 1-5, 2023 – 38th Annual Meeting of the Society for
Immunotherapy of Cancer (SITC)
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 Data Safety Monitoring Board 2 Hematopoietic Stem Cell
Transplant 3 acute Graft Versus Host disease
View source
version on businesswire.com: https://www.businesswire.com/news/home/20230926723892/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
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