- For the first half of 2022 turnover was €0.5 million and cash
and cash equivalents were €38.4 million as of June 30, 2022
- Significant milestones achieved in clinical and cGMP
manufacturing programs over first half of 2022:
- Initiation of pivotal open-label, single-arm, Phase 3 trial of
MaaT013 in acute Graft-vs-host-Disease in Europe in Q1 2022
- Initiation of a Phase 2a trial, sponsored by AP-HP, of MaaT013
in combination with immunotherapies in patients with metastatic
melanoma in Q2 2022
- Completion and publication of positive topline results of Phase
1b dose-finding clinical trial of MaaT033 in hemato-oncology
- Partnership with Skyepharma to establish cGMP manufacturing
facility, entirely dedicated to microbiome drug candidates
Regulatory News:
MaaT Pharma (EURONEXT:
MAAT – the “Company”), a French clinical-stage biotech and a
pioneer in the development of Microbiome Ecosystem
Therapies™ (MET) dedicated to improving survival
outcomes for patients with cancer, today announced its half
year financial results for the six-month period ended June 30, 2022
and provided a business overview.
Hervé Affagard, CEO and co-founder of MaaT Pharma stated,
“We are proud of the progress of our clinical and manufacturing
programs as we have delivered on the objectives we had set
ourselves at the time of our IPO on Euronext in 2021, even if the
current capital markets remain challenging for several companies in
our industry. Notably, the first half of 2022 has been marked by an
important milestone for MaaT Pharma as we started our pivotal
single-arm, open-label Phase 3 trial. We are satisfied with the
ongoing patient enrollment for this trial, despite the public
health context in the first half of the year. We are looking
forward to initiating a Phase 2b for our second drug candidate,
MaaT033, by the end of this year. Additionally, the construction of
our new cGMP manufacturing facility is taking shape, which will be
key to prepare for the entry of the first of our MaaT03X candidates
into clinical study by the end of 2023. MaaT03X, a new generation
of co-cultured drug candidates, is a donor-independent, highly
scalable, and indication-specific product design, which has the
potential to be a game-changer in improving patient responses to
immunotherapies. We have watched closely the positive vote from an
Advisory Committee convened by the FDA1 for the first marketing
authorization application for a microbiome drug product to treat
infectious diseases, that uses technology similar to our native
technology. In this context, we hope to soon see the first approval
of such a candidate, which would represent a major regulatory
milestone for the whole industry.”
Key Financial Results
The key unaudited financial results for the first half of 2022
are as follows:
Income Statement
In thousands of euros
06/30/2022
06/30/2021
Revenue
494
385
Cost of Goods Sold
(72)
(27)
Gross Margin
422
357
Other Income
1 793
1 189
Sales and distribution costs
(140)
(87)
General and administrative costs
(2 115)
(1 058)
Research and development costs
(7 328)
(4 384)
Operating income (expense)
(7 368)
(3 983)
Financial Income
0
0
Financial Expense
(50)
(64)
Net financial income (expense)
(49)
(64)
Income (loss) before income tax
(7 417)
(4 047)
Income tax expense
-
-
Net Income (loss) for the
period
(7 417)
(4 047)
Prepared in accordance with international
standards, IFRS
Revenues totaled €0.5 million for the half year ended June 30,
2022, which include compensation invoiced from the compassionate
access program generating a gross margin of €0.4 million.
Operating loss amounted to €7.4 million compared with €4.0
million in the first half of 2021, an increase of €3.4 million.
This increase reflects the growth of research and development costs
which have risen from €4.4 million in the first half of 2021 to
€7.3 million in 2022, representing an overall increase of €2.9
million and fully consistent with the advancement of activities,
offset in part the R&D tax credit of €1.8 million included in
“Other Income”:
- MaaT013:
- Phase 3 clinical trial, ARES, was initiated with the first
patient dosed in March 2022. Regulatory authorization was obtained
by the Company, to date, in six European countries – France,
Germany, Spain, Austria, Belgium, and Italy.
- MaaT Pharma continues to pursue the Early Access Program in
France as in 2021, allowing patients to benefit from early access
to the MaaT013 therapy, mainly for the treatment of acute
Graft-vs-host-Disease. As of today, the Company has safely treated
over 140 patients with MaaT013 in Europe.
- The proof-of-concept Phase 2a trial, PICASSO, was initiated in
April 2022 to evaluate MaaT013’s impact on the efficacy of Immune
Checkpoint Inhibitors (ICI) treatment in patients with metastatic
melanoma. The trial is sponsored by AP-HP with MaaT Pharma
supplying drug candidates and performing the microbiome profiling
of patients using its proprietary gutPrint® platform.
- MaaT033: Phase 1b clinical trial, CIMON, has been
completed with confirmation of principal positive results in June
2022 enabling the Company to define the dosing regimen for the next
development phase.
- MaaT03x: Pre-clinical trials proceed as planned.
- Partnership with Skyepharma to establish cGMP
manufacturing facility dedicated to ecosystem microbiome-based
therapeutics which is expected to be operational in 2023. A second
down payment was made to Skyepharma by the Company in the first
half of 2022.
General and administrative expenses amounted to €2.1 million for
the first half of 2022 compared with €1.1 million in 2021
reflecting the structuring of the Company to meet the needs of
being listed on the Euronext exchange and in support of the
clinical and development programs and the associated infrastructure
required.
The net loss amounts to €7.4 million as of June 30, 2022,
compared with €4.0 million as of June 30, 2021, reflecting the
growth of the Company and in particular the investment in
R&D.
Average employees evolved from 32 in the first half of 2021 to
43 in 2022 following the strengthening of clinical operations,
clinical development, manufacturing, quality assurance, and
administrative teams.
Cash Position
As of June 30, 2022, total cash and cash equivalents were €38.4
million, as compared to €43.3 million as of December 31, 2021.
The net decrease in cash position of €4.9 million between
December 31, 2021, and June 30, 2022, is primarily due to cash used
to finance operations for €7.1 million, cash used for investing of
€0.2 million, offset by net cash inflows related to financing
activities of €2.4 million essentially from the receipt of funds of
€2.7 million in bank loans from BNP Paribas and Caisse d’Epargne
Rhone Alpes (CERA). Total financial debt (including lease
liabilities) totaled €8.3 million as of June 30, 2022, of which
€1.0 million relates to state-backed loans (“PGE”). Additional
draws down, up to €4.4 million, are expected to be made in the
second half of 2022 from existing facilities signed with CIC and
Bpifrance.
Based on the development plans and corresponding cash needs, the
Company believes it has sufficient cash to finance its activities
up until the end of the third quarter of 2023.
Major milestones achieved in the first half of 2022
Clinical and operational development
In Europe, MaaT013, the Company’s lead asset, is currently being
evaluated in two clinical trials launched in Q1 2022:
- Ongoing pivotal open-label, single-arm Phase 3 trial in Europe
evaluating the safety and efficacy of MaaT013 in acute
Graft-versus-Host-Disease.
- Ongoing randomized, placebo-controlled Phase 2a
proof-of-concept clinical trial, sponsored by AP-HP, evaluating
MaaT013 in combination with Immune Checkpoint Inhibitors (ICI) for
patients with metastatic melanoma.
- In the U.S., interactions are ongoing with the Food & Drug
Administration (FDA) to extend MaaT013 clinical trial in the U.S.,
which remains on clinical hold following an FDA communication
received in August 2022 requiring additional information on the
safety and efficacy of the Company’s “pooling” approach.
In June 2022, the Company confirmed positive topline results for
its Phase 1b trial evaluating MaaT033, the Company’s oral-form drug
candidate, for patients with blood cancer. Having demonstrated
promising preliminary and interim engraftment data, the study was
completed early in January 2022.
In February 2022, the Company announced its partnership with
Skyepharma to build the largest cGMP facility in France entirely
dedicated to microbiome-based drug candidates, expected to be
operational in 2023. The investment is shared by MaaT Pharma and
Skyepharma totaling €8.1 million.
Next key milestones expected
End of second half of
2022
In Q4 2022, the Company expects to initiate a pivotal Phase 2b
trial evaluating MaaT033, the first oral drug candidate, to prevent
complication of allo-HSCT2. This randomized, double-blind,
placebo-controlled study will include 341 patients and evaluate
safety and efficacy of MaaT033 in improving overall survival and
preventing allo-HSCT complications for patients with blood
cancers.
First half of 2023
Regarding the ongoing Phase 3 trial with MaaT013, a first data
review is expected after enrollment of half the patients in the
study.
Regarding the ongoing proof-of-concept Phase 2a trial evaluating
MaaT013 in association with ICI for patients with metastatic
melanoma, a first internal data review focusing on safety and some
biomarker data is expected.
Upcoming financial communication*
- November 8, 2022 – Revenues and Cash Position Quarter 3
*Indicative calendar that may be subject to change.
Upcoming investor conference participation
- October 4, 2022 – Biotech Health Seminar – Portzamparc BNP
Paribas
- October 6-7, 2022 – Investor Access Event
- October 13-14, 2022–HealthTech Innovation Days #4 (HTID)
- November 29, 2022 – Investir Day
Upcoming scientific conference participation
- November 8-10, 2022 – 9th International Human Microbiome
Consortium (IHMC) Congress
- November 9-11, 2022 – 21st Société Francophone de Greffe de
Moelle et de Thérapie Cellulaire (SFGM-TC) Congress
- December 10-13, 2022 - 64th American Society of Hematology
(ASH) Annual Meeting
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, a Phase 3 clinical trial for 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.
1https://www.ferring.com/ferring-receives-positive-vote-from-u-s-fda-advisory-committee-for-rbx2660/
2Allo-HSCT = allogeneic hematopoietic stem cell transplantation.
More than 20,000 patients receive allo-HSCT each year (Global Data
2020).
View source
version on businesswire.com: https://www.businesswire.com/news/home/20220929005715/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 07 55 25 36
prichaud@maat-pharma.com
Trophic Communications - Corporate and medical
Communications Jacob VERGHESE or Gretchen SCHWEITZER +49 89 23
88 77 31 maat@trophic.eu
Maat Pharma (EU:MAAT)
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