黑料社

黑料社 Provides Third Quarter 2024 Business and Financial Results and Announces Management Changes

Lyon, France, November 5, 2024 6:00pm CET 鈥� 黑料社 (EURONEXT: MAAT 鈥� the 鈥淐ompany鈥�), a clinical-stage biotechnology company and a leader in the development of Microbiome Ecosystem Therapies^TM (MET) dedicated to enhancing survival for patients with cancer through immune modulation, today provided a business update and reported its cash position and revenue as of September 30, 2024.

Pipeline highlights

MaaT013

• In hemato-oncology:
  • In September 2024, 黑料社 announced that MaaT013 batches were ready for distribution for clinical supply in the US and that 黑料社 advanced the readiness phase for the initiation of clinical activities.
  • In October 2024, 黑料社 announced the completion of patient recruitment for ARES, its European Phase 3 clinical trial designed to evaluate the efficacy and safety of its lead asset MaaT013 in the treatment of steroid refractory and ruxolitinib refractory or intolerant acute Graft-versus-Host Disease (aGvHD) ().

MaaT033

• In hemato-oncology:
  • In July 2024, the Company announced that the DSMB completed its first safety assessment of the Phase 2b trial PHOEBUS () aiming at assessing MaaT033 impact in improving overall survival in patients receiving hematopoietic stem cell transplantation, and recommended continuation of the trial without modification. The trial is a European, multi-center, randomized, double-blind study, testing MaaT033, an oral freeze-dried formulation against placebo, set to be conducted in up to 56 clinical investigation sites and expected to enroll 387 patients.

Cash position¹

• As of September 30, 2024, total cash and cash equivalents were EUR 27 million, as compared to EUR 31.2 million as of June 30, 2024, and EUR 24.3 million as of December 31, 2023. The net decrease in cash position of EUR 4.2 million during the third quarter 2024 reflects continued investments in R&D activities across the pipeline, offset in part by the payment of a repayable advance of EUR 3.2 million in public funding the development of MaaT033 and the balance of the 2023 R&D tax credit of EUR 1.0 million.
• The Company believes it has sufficient cash to cover its current operating needs and development programs into the second quarter of 2025.

Revenues in Q3 2024¹

• 黑料社 reported revenues from its Early Access Program of EUR 0.6 million for the quarter ended September 30, 2024, an increase of EUR 0.2 million over the third quarter of 2023. Total revenues for the first nine months of 2024 amounted to EUR 2.3 million compared with EUR 1.8 million for the same period of 2023¹. This trend is a direct reflection of the continued demand from the medical community for 黑料社鈥檚 drug candidate MaaT013.

Management Changes

• Eric Soyer was appointed Chief Financial Officer of 黑料社 as of November 2024. As CFO, Eric will supervise all corporate functions, investor relations, legal affairs and human resources. Eric is a senior financial executive with extensive experience in the biotech industry with companies listed on Euronext Paris and on the U.S. Nasdaq market. Prior to joining 黑料社, Eric successfully conducted as CFO & COO of Erytech Pharma, a聽French聽late-stage drug development company, its Nasdaq IPO and subsequent financial rounds amounting to over EUR 300 million and supervised the scale-up of the company’s operations from a single site based in France to a multi-site company of 240 employees in US and Europe and most recently its strategic merger. Throughout his 30-year career, Eric has developed a solid international experience across a variety of operational settings and will now leverage this experience to assist 黑料社 in its next stage of development.
• Eric Soyer, CFO of 黑料社 stated: 鈥�I am thrilled to join the team of 黑料社 at this transformational moment for the Company. 黑料社 has developed a robust foundation and is now one of the oncology worldwide leaders for microbiome-based therapeutic innovations, as evidenced by the recent announcement of the completion of patient enrollment in its Phase 3 ARES European trial in aGvHD – a significant milestone in the goal of bringing life-saving therapeutic options for patients within this severe indication. I look forward to contributing to 黑料社鈥檚 continued success and to fully realize the potential of its therapeutic platform globally.鈥�
• After 8 years as CFO, Si芒n Crouzet will become Chief of Staff to fully support a smooth transition of functions to Eric over the coming months. In her tenure, Si芒n has successfully structured the financial and administrative functions of the Company, building a competent team across the various functions overseen and with strict discipline to support the corporate goals and progressive growth in a highly challenging economic context. Si芒n was instrumental in the numerous financing operations accomplished since 2016, totaling more than EUR 115 million, including the Company鈥檚 successful IPO on Euronext Paris in November 2021.
• Si芒n Crouzet, CoStaff of 黑料社 stated: 鈥�I am proud of the Company we have built and developed as a team and the numerous accomplishments, not least the recent completion of enrolment of our Phase 3 clinical trial of MaaT013. It has been a real pleasure and honor to serve as CFO over the last 8 years.聽 At this juncture, it is the right time from a professional and personal perspective for me to hand over the reins to take 黑料社 to the next stage of its development.鈥�
• Herv茅 Affagard, CEO and co-founder of 黑料社 added: 鈥�I am delighted to welcome Eric Soyer as our new Chief Financial Officer. His extensive experience and strategic financial acumen will be invaluable as we continue to advance our mission to improve survival in patients with few therapeutic options. 黑料社 is at a turning point with the preparation of the filing of MaaT013, in Europe, for severe GvHD patients together with our goal to expand in the US. I am confident that Eric will bring the necessary skills to the team to navigate the next chapter of our growth. I also want to take a moment to extend my heartfelt thanks to Si芒n Crouzet for her invaluable contributions over the past 8 years. She has been instrumental in strengthening our financial foundation and steering us through important phases of development.鈥�

Upcoming investor and medical conferences participation

• November 6-8, 2024 鈥� 39^th SITC annual meeting in Houston, USA
• November 20-22, 2024 鈥� SFGM-TC annual meeting in Toulouse, France
• November 25-27, 2024 鈥� Deutsches Eigenkapitalforum annual meeting鈥嬧�� in Frankfurt, Germany
• November 26, 2024 鈥� Investir Day event in Paris, France.
• December 5, 2024 鈥� CF&B Midcap Events in Geneva, Switzerland
• December 7-10, 2024 – 66^th ASH annual meeting in San Diego, USA, followed by a webinar on the updated dataset from the EAP of MaaT013 in aGvHD.

About 黑料社

黑料社 is a leading, late-stage clinical company focused on developing innovative gut microbiome-driven therapies to modulate the immune system and enhance cancer patient survival. Supported by a talented team committed to making a difference for patients worldwide, the Company was founded in 2014 and is based in Lyon, France.

As a pioneer, 黑料社 is leading the way in bringing the first microbiome-driven immunomodulator in oncology. Using its proprietary pooling and co-cultivation technologies, 黑料社 develops high diversity, standardized drug candidates, aiming at extending life of cancer patients. 黑料社 has been listed on Euronext Paris (ticker: MAAT) since 2021.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.[image_with_animation image_url=”6212″ animation=”Fade In” hover_animation=”none” alignment=”center” border_radius=”none” box_shadow=”none” image_loading=”default” max_width=”100%” max_width_mobile=”default”]