- The DSMB, based on Phase 3 trial ARES preliminary data,
concluded that MaaT013 has a favorable benefit/risk ratio with
“high efficacy and low toxicity” in 3rd line aGvHD1. This
evaluation confirms previous ones in a similar patient population
from the EAP2. Primary endpoint ORR now expected in mid Q4
2024.
- Good safety profile and positive efficacy results with 47%
overall survival (OS) at 12 months for all patients with aGvHD
(n=111) and 52% for patient subgroup within the EAP with a similar
profile to those in the ARES trial presented at ASH 2023. Long term
follow-up data at EBMT conference 2024.
- Ongoing recruitment for Phase 2b trial PHOEBUS investigating
MaaT033’s impact on OS in allo-HSCT patients.
- Completion of recruitment in March 2024 for Phase 2a trial
PICASSO sponsored by AP-HP3, evaluating MaaT013 in combination with
ICI in metastatic melanoma. Results expected end of 2024 or Q1
2025.
- First positive preclinical data for MaaT034, an AI-generated
co-cultured product aimed at improving responses to ICI, presented
at SITC conference 2023. New preclinical data at AACR conference
2024.
- Completion of the largest European cGMP manufacturing facility
for Microbiome Ecosystem Therapies with first batches
produced.
- FDA lifted the clinical hold and cleared the IND application
for MaaT013 in patients with aGvHD; EMA granted ODD to MaaT033 to
improve OS in patients undergoing allo-HSCT.
- As of December 31, 2023, cash and cash equivalents were €24.3
million, anticipated cash runway now set for end of Q3 2024.
Revenues of €2.2 million for 2023, the highest revenues generated
from the EAP so far.
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 of patients with cancer, today reported the
full-year 2023 annual results and provided a business overview.
“As we reflect on the achievements of 2023, I am proud to
announce that we have successfully delivered on milestones across
our entire pipeline, while being cash conscious. This past year has
been pivotal, laying the foundations for the next phase of
development for our lead asset MaaT013 with completion of the Phase
3 and readiness for commercialization. We look forward to reaching
new milestones in 2024 and anticipate a major inflection point with
the publication of the primary endpoint of our Phase 3. By relying
on our team and our network of physicians, and continuing to work
closely with regulators, we anticipate continuing to create value
for our shareholders and make significant progress in bringing new
therapeutic options for patients with cancer,” states Hervé
Affagard, CEO and co-founder of MaaT Pharma.
Pipeline highlights
MET-N
MaaT013
In hemato-oncology:
- 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 aGvHD4. The Company
has engaged active discussions with prominent US clinicians in the
field of stem cell transplantation to explore the most efficient
path forward to introduce MaaT013 to patients in the United
States.
- In July 2023, the Company announced that clinical data from its
Phase 2 study assessing MaaT013 as a treatment for aGvHD was
published in eClinicalMedicine, one of the Lancet Discovery Science
suite of journals.
- In October 2023, the Company announced that the DSMB5
unanimously recommended that the open-label, single arm pivotal
Phase 3 ARES clinical trial (NCT04769895), evaluating MaaT013 in
aGvHD, 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. Primary
endpoint, gastrointestinal overall response rate (GI-ORR), is now
expected mid Q4 2024.
- In December 2023, the Company presented positive results from
the Early Access Program (EAP) in Europe involving 111 patients
with aGvHD treated with MaaT013, at the 2023 American Society of
Hematology (ASH) Annual Meeting. The GI-ORR was 54% at day 28,
positively and significantly impacting overall survival (OS) with
47% OS at 12 months for all patients with aGvHD and 52% for a
patient subgroup from the EAP with a similar profile to those in
the ARES trial with GI-ORR of 61% and 58% of complete responses
observed at day 28.
- As a post period event, in March 2024, the Company announced
that it will present for the first time extended results that
include OS data after 12 months in more aGvHD patients from its EAP
that were treated with MaaT013. The data will be shared during an
oral presentation at the 50th Annual Meeting of the European
Society for Blood and Marrow Transplantation held in Glasgow, UK,
from April 14-17, 2024.
- As a post period event, the Company announces the launch of a
retrospective multicenter trial called CHRONOS in Europe. Its
objective is to provide the Company efficacy data for 3rd-line
therapies for patients not receiving MaaT013 or any Microbiome
intervention. This retrospective study does not impact cash
projections as funding is already secured.
In immuno-oncology:
- As a post period event, in March 2024, the Company informed on
the completion of patient recruitment for the Phase 2a clinical
trial (NCT04988841) sponsored by AP-HP and in collaboration with
INRAe6 and Institut Gustave Roussy7, evaluating MaaT013, the
Company’s lead product candidate, in combination with immune
checkpoint inhibitors (ICI), ipilimumab (Yervoy®) and nivolumab
(Opdivo®) in ICI naïve patients with metastatic melanoma. Having
reached this key recruitment milestone, the first publication will
be submitted at the end of 2024 or in the first quarter of
2025.
MaaT033
In hemato-oncology:
- In April 2023, data from the Phase 1b study (CIMON) with
MaaT033, previously communicated during the 64th annual ASH
meeting, were also presented at the EBMT 2023 conference.
- In September 2023, the Company announced that the European
Medicines Agency (EMA) had granted orphan drug designation (ODD) to
MaaT033, which is aimed at improving overall survival in patients
undergoing allo-HSCT8. The EMA 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.
- In November 2023, the Company announced that the first patient
was treated in the Phase 2b trial (PHOEBUS) investigating the
efficacy of MaaT033 in improving OS at 12 months in patients with
blood cancer that are 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.
- In November 2023, the Company announced that its ongoing Phase
2b trial, PHOEBUS has been selected for funding of 7.4 million EUR
as part of the France 2030 Health Innovation plan, in response to
the ‘Innovation in Biotherapy and Bioproduction’ call for projects
from the ‘Biotherapies and Bioproduction of Innovative Therapies’
acceleration strategy, operated by Bpifrance (project code:
METALLO). Post period the first tranche of 1.8 million EUR was
received.
In neurodegenerative diseases:
- In September 2023, the Company announced that the first patient
was dosed in the IASO Phase 1b pilot study (NCT05889572) in
Amyotrophic Lateral Sclerosis (ALS), also known as Lou Gehrig's
disease in the U.S. and Charcot's disease in French-speaking
countries. As a post period event, in February 2024, the Company
announced that the DSMB reviewed safety data in the IASO trial in
the first 8 patients with ALS treated with MaaT033. The DSMB
recommended that the trial continue without modifications.
MET-C
MaaT034
In immuno-oncology:
- In November 2023, the Company had two presentations at the 38th
Society for Immunotherapy of Cancer (SITC) Annual Meeting
highlighting 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. The first clinical batches are expected to be produced
in 2024 and the first-in-human study is planned for 2025.
- As a post period event, in March 2024, the Company announced
that it will present new in vitro data at the American Association
for Cancer Research (AACR) Annual Meeting 2024, taking place on
April 5-10 in San Diego, California.
Corporate update
- In February 2023, the Company completed a successful capital
increase of approximately €12.7 million with the support of current
shareholders.
- In July 2023, MaaT Pharma joined the Microbiome Therapeutics
Innovation Group (MTIG). MTIG is a coalition of companies focused
on developing FDA-approved microbiome therapeutics and products to
improve medical care, outcomes, and cost-effectiveness.
- 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.
- During 2023 and Q1 2024, MaaT Pharma reinforced its board of
directors, executive team, and key functions:
- Karim Dabbagh as Chairman and Nadia Kamal as Director, both
independent.
- Jonathan Chriqui, as Chief Business Officer and member of the
executive management team.
- Guilhaume Debroas, as Head of Investor Relations.
Financial highlights
The key financial results for the 2023 full year are as
follows:
Income Statement
In thousands of euros
31 December 2023
31 December 2022
Revenue
2 228
1 430
Cost of Goods Sold
(573)
(339)
Gross Margin
1 655
1 091
Other Income
4 667
4 122
Sales and distribution costs
(449)
(347)
General and administrative costs
(4 965)
(4 111)
Research and development costs
(20 851)
(14 311)
Operating income (expense)
(19 943)
(13 557)
Financial Income
639
45
Financial Expense
(413)
(201)
Net financial income (expense)
226
(156)
Income (loss) before income tax
(19 717)
(13 713)
Income tax expense
-
-
Net Income (loss) for the
period
(19 717)
(13 713)
Prepared in accordance with international
standards, IFRS.
Revenues totaled €2.2 million for the year ended December 31,
2023, the highest revenues generated thus far by the Company, which
includes compensation invoiced from the Early Access Program in
France and for which data was presented at the American Society of
Hematology Annual Meeting in December 2023. The gross margin
generated by the compassionate access program amounts to €1.7
million.
Operating expense amounted to €19.9 million compared with €13.6
million for 2022, an increase of €6.3 million. This increase
reflects the growth of research and development costs which have
risen from €14.3 million in 2022 to €21.2 million in 2023,
representing an overall increase of €6.9 million and consistent
with the advancement of clinical and operational activities as
detailed in the pipeline highlights’ section above.
Other income of €4.7 million includes the R&D tax credit of
€3.6 million, an increase of €0.4 million compared with prior year,
which amounted to €3.2 million and in line with the growth of
research and development activities and eligible expenses.
General and administrative expenses amounted to €5.0 million
compared with €4.1 million in 2022 reflecting the increase in
regulatory advisory costs and expenses to support the early access
program.
The net loss amounts to €19.7 million for the year ended
December 31, 2023, compared with €13.7 million for the year ended
December 31, 2022.
Average annual employees evolved from 43 in 2022 to 53 in 2023
following the strengthening of the clinical and production and
supply chain and to a lesser extent administrative teams.
Cash Position
As of December 31, 2023, total cash and cash equivalents were
€24.3 million, as compared to €31.7 million as of September 30,
2023, and €35.2 million as of December 31, 2022.
The net decrease in cash position of €11.0 million between
December 31, 2022, and December 31, 2023, is due to the financing
of operations for a total of €18.7 million, offset by cash inflows
from financing of €8.1 million. Cash inflows from financing
reflects the share capital increase in February 2023 of
approximately €12.7 million, offset by debt repayments over 2023
€4.2 million. Total financial debt totaled €14.1 million as of
December 31, 2023, of which €0.4 million relates to state-backed
loans (“PGE”) and €6.1 million of lease liabilities, which includes
future contractual payments due to Skyepharma for the use of the
manufacturing facility completed in 2023.
Based on the development plans and corresponding cash needs, the
Company believes it has sufficient cash to finance operations to
the end of Q3.2024 extending the cash runway by three months
compared to prior communications as a result of a voluntary
slowdown in headcount growth, optimization of its manufacturing
plan and prioritizing expenses to support on the roll out of the
Phase 2b trial PHOEBUS in France and Germany (approved countries)
and finalizing recruitment into the Phase 3 ARES trial in Europe.
The Company has active discussions ongoing to finance operations
beyond the end of Q3.2024 and remains confident in extending its
cash runway.
Note: This press release contains financial data approved by the
Board of Directors on March 27, 2024, based on the financial
statements for the year ended December 31, 2023. The audit is in
progress at the date of this communication.
Upcoming financial communication*
- May 14, 2024: Publication of revenues for Q1 2024
- May 28, 2024: Annual General Shareholders Meeting
- September 19, 2024: Publication of half year financial results
H1
- November 5, 2024: Publication of revenues for Q3 2024
*Indicative calendar that may be subject to change.
Upcoming investor conferences participation
- April 15-17, 2024 – Kempen Life Sciences Conference,
Amsterdam
- June 11-12, 2024 – Portzamparc Mid & Small Caps 2024
Conference
- June 25-27, 2024 – Stifel European Healthcare Summit Lyon
Upcoming scientific conference participation
- April 5-10, 2024 - American Association for Cancer Research
(AACR) Annual Meeting 2024, San Diego
- April 14-17, 2024 – 50th Annual meeting of the European Bone
Marrow Transplant (EBMT), Glasgow
The Company’s universal registration document, which includes
the annual financial report, will be available on MaaT Pharma’s
website on 02/04/2024: www.maatpharma.com
---
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 acute Graft versus Host Disease
2 Early Access Program
3 Assistance Publique - Hôpitaux de Paris is the leading
university hospital center in Europe
4 acute Graft Versus Host disease
5 DSMB = Data Safety Monitoring Board
6 National Research Institute for Agriculture, Food and the
Environment
7 Leading Cancer Centre in Europe
8 Allo-HSCT : Allogeneic hematopoietic stem cell
transplantation
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version on businesswire.com: https://www.businesswire.com/news/home/20240328293825/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 Jacob
VERGHESE or Priscilla PERRIN +49 151 7441 6179 maat@trophic.eu
Maat Pharma (EU:MAAT)
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