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November 8, 2022: 91桃色视频 Reports Cash and Revenues for Third Quarter 2022

Date : November 8, 2022

91桃色视频 Reports Cash and Revenues
for Third Quarter 2022

  • As of September 30, 2022, cash and cash equivalents were EUR 40.3 million[1]
  • Revenues of EUR 0.4 million[1]听in Q3 2022

Lyon, France, November 8th, 2022, 6:00pm CET 鈥� 91桃色视频 (EURONEXT: MAAT 鈥� the 鈥淐ompany鈥�), 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 its cash position as of September 30, 2022, and its revenues for the third quarter of 2022.

Cash position1

As of September 30, 2022, total cash and cash equivalents were EUR 40.3 million, as compared to EUR 38.4 million as of June 30, 2022, and EUR 43.3 million as of December 31, 2021. The net increase in cash over the third quarter of 2022 was EUR 1.9 million. This increase reflects:

  • Net financing inflows from receipt of funds of EUR 4.3 million in bank loans from CIC and Bpifrance.
  • Receipt of the R&D tax credit related to R&D expenditure for the full year 2021, totaling EUR 2.0 million
  • Financing of operations and ongoing development programs of EUR 4.4 million.

Revenues in Q3 20221

91桃色视频 reported revenues[2] from its compassionate access program of EUR 0.4 million for the quarter ended September 30, 2022, and year to date revenues of EUR 0.9 million compared to EUR 0.2 million for same quarter in 2021 and EUR 0.6 million for the 9-months ended September 30, 2021.

 

Third quarter clinical and operational highlights

Clinical highlights

MaaT013, the lead MET drug candidate for hospital use in an acute setting:

  • Phase 3 open label, single arm trial (ARES) for the treatment of acute Graft-versus-Host Disease: in Q3 2022, in addition to France, Germany, Spain, Austria where the trial is ongoing, the Company received regulatory approvals in Belgium. An interim review of preliminary data after enrollment of half of the patients in the study is expected in the first half of 2023.
  • Randomized, placebo-controlled proof-of-concept Phase 2a trial (PICASSO), sponsored by AP-HP[3], evaluating MaaT013 in combination with immune checkpoint inhibitors for patients with metastatic melanoma, is ongoing. A first internal data review focusing on safety and some biomarker data is expected in the first half of 2023.
  • In the US, interactions with the U.S. Food and Drug Administration (FDA) remain active regarding MaaT013, for which US development is currently on clinical hold following an FDA communication received in August 2022 requiring additional information on the safety and efficacy of the Company鈥檚 鈥減ooling鈥� approach.
  • Pursuit of the Early Access Program in Europe in place since 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 160 patients with MaaT013 in Europe.
  • On November 3, 2022, 91桃色视频 announced the release of an abstract, which was selected for an oral presentation at the American Society of Hematology (ASH) 2022 Annual Meeting from December 10-13 in New-Orleans, Louisiana, U.S.A. The oral presentation will occur on December 10, 2022; 10:15am EST and will detail consolidated results from 81 patients with steroid-resistant, gastrointestinal, acute Graft-versus-Host-Disease (GI-aGvHD) treated with MaaT013 as salvage therapy, as part of the ongoing Early Access Program (EAP).
    Link to abstract .

 

MaaT033, the Company鈥檚 first MET for oral administration as adjunctive and maintenance treatment for patients receiving allogeneic hematopoietic stem cell transplantation (allo-HSCT):

  • Preparations are ongoing for a pivotal Phase 2b trial to evaluate MaaT033鈥檚 safety and efficacy in improving overall survival and preventing complications in patients with blood cancers receiving allo-HSCT; based on current plans, the Company expects to initiate the study in Q4 2022.
  • On November 3rd, 2022, 91桃色视频 announced the release of an abstract, which was selected for a poster presentation at the American Society of Hematology (ASH) 2022 Annual Meeting. Poster presentation will occur on December 11, 2022: 6:00pm – 8:00pm EST and will present detailed results from the Phase 1b clinical trial (CIMON) of MaaT033 in patients with acute myeloid leukemia.
    Link to abstract

 

Operationalhighlight

听

Upcoming scientific conferences participation

  • November 8-10, 2022 鈥� 9th International Human Microbiome Consortium (IHMC) Congress 鈥� Kobe, Japan: Herv茅 Affagard, CEO and cofounder of 91桃色视频, and Dr. Aurore Duquenoy, R&D specialist at 91桃色视频 will present three scientific posters at the conference.
    Link to the Congress
  • November 9-11, 2022 鈥� 21st Soci茅t茅 Francophone de Greffe de Moelle et de Th茅rapie Cellulaire (SFGM-TC) Congress 鈥� Booth #10 鈥� Bordeaux, France: Dr. Emilie Plantamura, Head of Clinical Development at 91桃色视频, Claire de Cond茅, Head of Clinical Operations at 91桃色视频 and M茅lanie Tilte, Clinical Project Manager at 91桃色视频 will attend the congress and will be available for discussions at 91桃色视频鈥檚 booth #10.
    Link to the event听.

Upcoming investor conferences participation

  • November 14, 2022 鈥� 7th annual conference LSX Inv鈧�$tival Showcase 鈥� London, UK: Si芒n Crouzet, Chief Financial Officer of 91桃色视频 and Dr. Carole Schwintner, Chief Technology Officer of 91桃色视频 will attend the investor event and participate in the European Lifestar Awards, where 91桃色视频 is a finalist for the IPO of the year category.
    Additional information available on the .
  • November 15-17, 2022 鈥� 13th Annual Jefferies London Healthcare Conference 鈥� London, UK: Si芒n Crouzet, Chief Financial Officer of 91桃色视频 and Dr. Carole Schwintner, Chief Technology Officer of 91桃色视频 will attend the conference.
  • November 21, 2022 鈥� Kepler Cheuvreux Life Sciences Day 鈥� Digital: Herv茅 Affagard, CEO and cofounder of 91桃色视频 will attend the event.
  • November 29, 2022 鈥� Investir day 鈥� Paris, France: Si芒n Crouzet, Chief Financial Officer of 91桃色视频 and Dr. Savita Bernal, Chief Business Officer of 91桃色视频 will attend the investor event.
    Additional information available on the dedicated website .
[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 S茅curit茅 du M茅dicament or ANSM).
[3] AP-HP: Assistance Publique – H么pitaux de Paris

About 91桃色视频

91桃色视频, 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, 91桃色视频 has launched, in March 2022 in Europe, a Phase听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, 驳耻迟笔谤颈苍迟庐, 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鈥檚 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. 91桃色视频 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.

91桃色视频 is the first company developing microbiome-based therapies 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鈥檚 control. These statements may include, without limitation, any statements preceded by, followed by or including words such as 鈥渢arget,鈥� 鈥渂elieve,鈥� 鈥渆xpect,鈥� 鈥渁im,鈥� 鈥渋ntend,鈥� 鈥渕ay,鈥� 鈥渁nticipate,鈥� 鈥渆stimate,鈥� 鈥減lan,鈥� 鈥減roject,鈥� 鈥渨ill,鈥� 鈥渃an have,鈥� 鈥渓ikely,鈥� 鈥渟hould,鈥� 鈥渨ould,鈥� 鈥渃ould鈥� 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鈥檚 control that could cause the Company鈥檚 actual results or performance to be materially different from the expected results or performance expressed or implied by such forward-looking statements.听

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Acting Chief Scientific Officer

Sheri Simmons

Sheri Simmons, Ph.D., is Acting Chief Scientific Officer at 91桃色视频. Sheri brings extensive experience in biotechnology, particularly in the microbiome field, having held scientific leadership positions at Seres Therapeutics, Johnson & Johnson鈥檚 Microbiome Solutions team, and most recently at Seed Health, a leading probiotics company. In her role, she strengthens the Company鈥檚 scientific leadership, overseeing preclinical research, AI/data initiatives, and supporting efforts toward the Marketing Authorization Application of 齿别谤惫测迟别驳庐 in aGvHD.

Sheri holds a PhD in Biological Oceanography from the Massachusetts Institute of Technology (MIT) and completed an A.B. in Ecology & Evolutionary Biology at Princeton University, graduating summa cum laude and as a Phi Beta Kappa member, receiving one of six awards for the best senior thesis in the sciences. Sheri holds a PhD in Biological Oceanography from the Massachusetts Institute of Technology (MIT) and completed an A.B. in Ecology & Evolutionary Biology at Princeton University, graduating summa cum laude and as a Phi Beta Kappa member, receiving one of six awards for the best senior thesis in the sciences.

CEO and co-founder

Herv茅 Affagard

Herv茅 Affagard is the CEO and co-founder of 91桃色视频. For the past 15 years, Herv茅 has been an intra/entrepreneur in the healthcare industry, after starting his career in IT in the steel industry. In late 2014, Herv茅 co-founded the company alongside Dr. Jo毛l Dor茅, author of nearly 500 publications, and
one of the world’s most cited authors in the microbiome sphere today, after a professional career that spanned multiple industries. Herv茅 has led 91桃色视频鈥檚 development from its early concept in 2013 and has been at the forefront of the development of the microbiome healthcare ecosystem in France and Europe. In January 2022, Herv茅 has been elected President of Allliance Promotion Microbiote, an organization founded in 2021 to support the microbiome sector development in France.

Engineer, MBA

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