Regulatory News:
- As of December 31, 2022, cash and cash equivalents were €35.2
million (prior to the capital raise in February 2023) and turnover
was €1.4 million
- Significant milestones on clinical programs in 2022:
- MaaT013:
- Initiation in March 2022 of Phase 3 open label, single arm
clinical trial in Europe for the treatment of acute
Graft-versus-Host Disease (hemato-oncology)
- Initiation in April 2022 of Phase 2a proof-of-concept trial,
sponsored by AP-HP, to improve patients’ responses to
immunotherapies in metastatic melanoma (immuno-oncology)
- MaaT033:
- Completion of Phase 1b in January 2022 and topline results
published in June 2022 for patients with acute myeloid leukemia
following allogeneic hematopoietic stem-cell transplantation
(allo-HSCT) and presentation of positive data at the 2022 ASH
conference
- Preparation ongoing for a Phase 2b trial to evaluate MaaT033 in
improving overall survival and preventing complications in patients
with blood cancers receiving allo-HSCT
- Successful capital raise in February 2023 of approximately
€12.7 million with the support of current shareholders
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 reported the
full-year 2022 annual results and provided a business overview.
Hervé Affagard, CEO and co-founder of MaaT Pharma states,
“in 2022, we have successfully executed on key clinical and
manufacturing objectives despite a difficult economic environment.
With our lead asset, MaaT013, currently in a Phase 3 clinical trial
in hemato-oncology, it is our ambition to make it quickly
accessible to all patients fighting acute Graft-versus-Host Disease
in need of a safe and effective therapeutic option. Our clinical
development pipeline continues to progress with positive Phase 1b
data for MaaT033 announced in 2022, the commencement of a Phase 2b
trial in the first half of 2023 as well was the ongoing Early
Access Program in Europe for MaaT013. With the construction of our
manufacturing facility to be completed by mid-2023 and the roadmap
we shared at the beginning of the year, we are excited with the
progress we have made to advance our microbiome therapies that we
believe could become a new pillar in treating cancer."
Key Financial Results
The key audited financial results for the 2022 full year are as
follows:
Income Statement
In thousands of euros
31 December 2022
31 December 2021
Revenue
1 430
972
Cost of Goods Sold
(339)
(166)
Gross Margin
1 091
806
Other Income
4 122
2 390
Sales and distribution costs
(347)
(217)
General and administrative costs
(4 111)
(2 727)
Research and development costs
(14 311)
(9 145)
Operating income (expense)
(13 557)
(8 893)
Financial Income
45
0
Financial Expense
(201)
(126)
Net financial income (expense)
(156)
(126)
Income (loss) before income tax
(13 713)
(9 019)
Income tax expense
-
-
Net Income (loss) for the
period
(13 713)
(9 019)
Prepared in accordance with international standards, IFRS.
Revenues totaled €1.4 million for the year ended December 31,
2022, 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 2022. The gross
margin generated by the compassionate access program amounts to
€1.1 million.
Operating expense amounted to €13.6 million compared with €8.9
million for 2021, an increase of €4.7 million. This increase
reflects the growth of research and development costs which have
risen from €9.1 million in 2021 to €14.3 million in 2022,
representing an overall increase of €5.2 million and consistent
with the advancement of clinical and operational activities as
detailed in the 2022 key achievements’ section below.
Other income of €4.1 million includes the R&D tax credit of
€3.2 million, an increase of €1.2 million compared with prior year,
which amounted to €2.0 million and in line with the growth of
research and development activities.
General and administrative expenses amounted to €4.1 million
compared with €2.7 million in 2021 reflecting the recurring costs
and structuring of the Company to meet the needs of its listing on
Euronext Paris regulated market and to support the different
clinical and development programs.
The net loss amounts to €13.7 million for the year ended 31
December 2022 compared with €9.0 million for the year ended 31
December 2021.
Average annual employees evolved from 33 in 2021 to 43 in 2022
following the strengthening of the clinical and scientific teams,
along with the R&D, technical and regulatory departments.
Cash Position
As of December 31, 2022, total cash and cash equivalents were
€35.2 million, as compared to €38.4 million as of June 30, 2022,
and €43.3 million as of December 31, 2021.
In thousands of euros
31 December 2022
31 December 2021
Net cash used in operating activities
(12 605 )
(7 929 )
Net cash used in investing activities
(815 )
(238 )
Net cash used in financing activities
5 364
31 558
Net change in cash and cash
equivalents
(8 057 )
23 391
The net decrease in cash position of €8.1 million between
December 31, 2021, and December 31, 2022, is due to the financing
of operations for a total of €12.6 million, offset by cash inflows
from financing of €5.4 million. Cash inflows from financing
reflects new financial debt, offset by debt repayments over 2022
€1.9 million. Total financial debt (including lease liabilities)
totaled €11.4 million as of December 31, 2022, of which €0.9
million relates to state-backed loans (“PGE”).
Based on the development plans, corresponding cash needs and
following the capital increase in February 2023, the Company
believes it has sufficient cash to finance operations into the
second quarter of 2024.
2022 Key achievements
Pipeline highlights
MaaT013
- In March 2022, the Company announced the initiation of its
Phase 3 open label, single arm, pivotal trial, called ARES,
evaluating MaaT013 in treating patients with acute
Graft-versus-Host Disease (aGvHD). The trial is ongoing in six
European countries including France, Austria, Spain, Belgium,
Germany, and Italy. In the US, interactions with the FDA remain
active regarding MaaT013, for which US development is currently on
clinical hold following an FDA communication received in August
2022. In February 2023, the Company announced new discussions with
the FDA which have been detailed in the section below “First half
of 2023”.
- In April 2022, the Company announced the initiation of a
randomized, placebo-controlled Phase 2a, proof of concept, clinical
trial in France sponsored by AP-HP, evaluating MaaT013’s impact on
the efficacy of immune checkpoints inhibitors (ICI) treatments in
patients with metastatic melanoma.
- In 2022, the Company continued the Early Access Program in
Europe allowing patients to benefit from early access to the
MaaT013 drug candidate, mainly for the treatment of aGvHD. As of
today, the Company has safely treated over 160 patients with
MaaT013 in Europe.
- In December 2022, the Company presented compelling consolidated
data from 81 patients in the Early Access Program in France at the
American Society of Hematology Annual Meeting in December
2022.
MaaT033
- In the first half of 2022, the Company announced positive
topline results for its Phase 1b open-label, dose-ranging clinical
trial, called CIMON, investigating the maximum tolerated dose of
MaaT033 in patients with acute myeloid leukemia or high-risk
myelodysplastic syndrome who have undergone intensive chemotherapy
and confirming clinical potential of MaaT Pharma’s oral drug
candidate. These promising results support the launch of the Phase
2b clinical trial, called PHOEBUS, to improve overall survival and
to prevent complications in patients with blood cancers receiving
allo-HSCT.
- In December 2022, the Company presented the Phase 1b clinical
data in a poster format at the American Society of Hematology
Annual Meeting.
MaaT03X
- In 2022, the Company has been consolidating in vivo and in
vitro data with MaaT03X and continuing its product development
characterization.
Financial highlight
- In February 2022, the Company announced the construction of its
cGMP manufacturing facility in France, dedicated to ecosystem
microbiome-based therapeutics, in partnership with Skyepharma. A
total down payment of €1.1 million has been made in 2022 for a
total of €1.4 million cumulatively. The facility is expected to be
operational by mid-2023.
First half of 2023
- In January 2023, the Company announced the expansion of its
scientific research to neurodegenerative diseases with a first
trial in Amyotrophic Lateral Sclerosis (ALS). The Company is now
preparing to launch a Phase 1b pilot study to evaluate MaaT033 in
ALS, following ANSM regulatory authorizations received in March
2023 - the inclusion of the first patient is expected in H1
2023.
- In February 2023, the Company completed a successful capital
increase of approximately €12.7 million with the support of current
shareholders.
- The ongoing international multicenter open-label, single arm
pivotal Phase 3 trial (ARES) evaluating MaaT013 in aGvHD is ongoing
in Europe – the Data and Safety Monitoring Board (DSMB) review is
expected to take place at the end of the first half of 2023, if
half of the patients have been recruited.
- In February 2023, the Company announced the receipt of a letter
from the FDA indicating that the Agency agreed to a defined list of
conditions that could enable clinical evaluation of MaaT013 in the
U.S. These measures have since been included by the Company and
submitted to the FDA. The communication from the FDA therefore
provides a path forward regarding MaaT Pharma’s pooling technology
for this trial.
- The Phase 2a proof-of-concept clinical trial evaluating MaaT033
in association with ICI in metastatic melanoma, sponsored by AP-HP,
in France is ongoing - biological biomarker data are expected in H1
2023 after half of the patients have been enrolled and achieved
their evaluation 9 weeks after randomization.
- The preparations are ongoing to initiate the randomized
placebo-controlled Phase 2b trial (PHOEBUS) evaluating MaaT033 in
improving overall survival and to prevent complications in
allo-HSCT patients and the Company has received French and German
regulatory authorizations in March 2023– study is expected to start
in Q2 2023.
The Company’s universal registration document, which includes
the annual financial report, will be available on MaaT Pharma’s
website: www.maatpharma.com
Upcoming financial communication*
- May 9, 2023 – Revenues and Cash Position Quarter 1
- June 19, 2023 – Annual General Meeting
- July 27, 2023 – Revenues and Cash Position Quarter 2
- September 26, 2023 – Half-year Results 2023
- November 9, 2023 - Revenues and Cash Position Quarter 3
*Indicative calendar that may be subject to change.
Upcoming investor conferences participation
- April 4, 2023 – Investor Access Conference, Paris
- April 26, 2023 – Kempen Life Sciences Conference,
Amsterdam
Upcoming scientific conference participation
- April 23-26, 2023 – 49th Annual meeting of the European Bone
Marrow Transplant, Paris
- June 28-30, 2023 – 8th Microbiome Movement – Drug Development
Summit, Boston
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®, supports the development and expansion of its
pipeline by determining novel disease targets, evaluating drug
candidates, and identifying 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.
View source
version on businesswire.com: https://www.businesswire.com/news/home/20230330005581/en/
MaaT Pharma – Investor Relations Hervé AFFAGARD,
Co-founder and CEO Siân CROUZET, COO / CFO +33 4 28 29 14 00
invest@maat-pharma.com
MaaT Pharma – Media Relations Pauline RICHAUD, Senior PR
& Corporate Communications Manager +33 6 14 06 45 92
prichaud@maat-pharma.com
Trophic Communications Corporate and Medical
Communications Jacob VERGHESE or Gretchen SCHWEITZER, +49 151
7441 6179 maat@trophic.eu
Maat Pharma (EU:MAAT)
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