MaaT-013

Alan Bash is joining Legend Biotech as its president of Carvykti , an unconventional, newly-created role to oversee the commercial future of the biotech’s sole marketed cell therapy, among other aspects. Legend is developing Carvykti in partnership with Johnson & Johnson , which reported $286 million in sales in the third quarter. The BCMA-targeted cell therapy is expected to grow into a blockbuster multiple myeloma treatment — in large part as a result of a label expansion to earlier-line patients in April. Legend said in its press release that Bash’s new role will be to oversee Carvykti’s “commercial, technical operations, and quality functions.” Despite impressive results reported from the drug’s clinical studies, Legend and J&J have struggled to meet the commercial demand for the cell therapy. Carvykti has pulled ahead in a field that includes Bristol Myers Squibb ’s Abecma . But it faces an up-and-coming challenger in Gilead and Arcellx : The two companies announced on Tuesday that they had dosed the first patient in a Phase 3 trial of their experimental cell therapy anito-cel , which they say does not come with certain neurotoxicities reported with Carvykti. Bash had joined targeted therapeutics biotech ZielBio as CEO in early 2023. Before that, he was briefly head of Checkmate Pharmaceuticals as the immuno-oncology biotech sold to Regeneron for $250 million in cash. — Lei Lei Wu → Novo Nordisk said in its Q3 report that North America head Doug Langa will step aside at the end of the year “in order to focus on personal priorities and take up a role as senior advisor to Novo Nordisk’s executive management.” Novo has installed corporate development chief Dave Moore as the head of US commercial operations, while CFO Karsten Munk Knudsen will orchestrate the Danish pharma’s corporate strategy. Two days after the FDA declared that Ozempic and Wegovy were available in all doses, Novo’s semaglutide was on the march again, generating positive results in patients with metabolic dysfunction-associated steatohepatitis (MASH) and setting up a possible showdown with Madrigal Pharmaceuticals in an indication also referred to as NASH. → Moderna CEO Stéphane Bancel had been in charge of commercial operations since last December, when the company parted ways with chief commercial officer Arpa Garay . Bancel is now handing over those duties to president Stephen Hoge at Moderna, which made several other changes to its leadership team. Rose Loughlin , the SVP of research and early development, has been elevated to EVP of research. She came to Moderna from Biogen in 2016 as director of business development. Elsewhere, longtime GSK vet Jacqueline Miller has been promoted to CMO at the Covid vaccine titan after she had been SVP and therapeutic area head for infectious diseases. Finally, HR chief Tracey Franklin has expanded the scope of her responsibilities, becoming chief people and digital technology officer. She was chief HR talent and strategy officer at the end of her 14-year career at Merck . Moderna’s late entry into the RSV race produced only $10 million in third-quarter sales for the vaccine, miles behind the market leaders GSK and Pfizer , who haven’t exactly been scorching the nets themselves. But Moderna did turn in a profit as its shares $MRNA received a momentary boost before falling 3% on Thursday. → Axel Sven Malkomes will be the next CFO of German mRNA vaccine maker CureVac on Nov. 11. He succeeds Pierre Kemula , who just started his new CFO gig at Agomab . Malkomes is the ex-finance chief at two other German companies: Cardior Pharmaceuticals , the heart disease biotech that Novo Nordisk bought in March for $1.1 billion; and BioNTech ’s TCR partner Medigene . He’s also a board member at Cellectis . In July, CureVac said it would lay off 30% of its employees as GSK shelled out $429 million upfront for full control of the pair’s flu and Covid vaccine candidates. “It’s never nice to have this kind of news, but I do believe we need to do it now out of a position of financial strength,” CureVac CEO Alexander Zehnder told Endpoints News when the job cuts were announced. → Another notable CFO hire comes from Seaport Therapeutics , the Endpoints 11 winner that followed up its $100 million launch round with a $225 million Series B haul a few weeks ago. Lauren White had held this role for nine months at Elahere developer ImmunoGen , which was purchased by AbbVie for $10.1 billion . She landed her first CFO job at C4 Therapeutics in June 2021 after nine years at the Novartis Institutes for BioMedical Research . Are IPO plans not far behind? Time will tell. “I’m enjoying my brief hiatus as a private CEO right now,” Seaport chief Daphne Zohar said in an interview with Endpoints. → Swedish rare disease specialist Sobi has nominated David Meek as chairman of the board. Not long after Meek’s departure as CEO of Mirati , Bristol Myers swooped in to buy the company and its KRAS drug Krazati to compete with Amgen ’s Lumakras in the space. Meek has also held the top spot at Ipsen and FerGene , and has board seats at uniQure and Cullinan Therapeutics . → Mene Pangalos is the newest board member at Quotient Therapeutics , a Flagship joint that debuted last year and teamed up with Pfizer in August. Since his retirement from AstraZeneca , Pangalos has picked up a board seat at Absci and will join the board of directors at Biogen in January. He’s also on the scientific advisory board at Demis Hassabis ’ Isomorphic Labs. (By the way, check out this week’s Q&A with Hassabis and Andrew Dunn from the Financial Times ’ Global Pharma and Biotech Summit.) → After losing its former CEO Raj Kannan back in July, I-Mab has now locked Sean Fu into the position. Fu has been serving in the interim since Kannan’s exit. Prior to I-Mab, Fu was operating partner of ABio-X and CEO of RVAC Medicines and GeneLeap . Earlier in his career, Fu was with Merck, where he helped lead the integration work of the company following its $42 billion merger with Schering-Plough . It’s been quite a year for I-Mab: Back in April, the company officially spun out its China operations into a new company, I-Mab Biopharma (Hangzhou) , in a bid to win over investors. → Verrica Pharmaceuticals CEO Ted White is out after data for its basal cell carcinoma candidate VP-315 failed to move the needle with investors and job cuts affected 47 staffers. Verrica also drastically reduced its sales presence for its molluscum contagiosum drug Ycanth , from 80 sales territories to 35. In walks Jayson Rieger as president and CEO, and John Kirby as interim finance chief to lead a “leaner and more efficient operating structure,” as chairman Paul Manning put it . Rieger has spent more than a decade with PBM Capital , while Kirby is the former CFO of Aceragen and Idera Pharmaceuticals . → London-based protein degradation biotech Kesmalea Therapeutics has recruited Robert Johnson to steer the Syncona -backed company as CEO. Johnson’s résumé includes stints as CEO of Adrestia Therapeutics (acquired by Insmed ) and co-founder and CBO of Boston-based gene therapy company Affinia Therapeutics . → ElevateBio ’s gene editing sub Life Edit has welcomed Amy Pooler as SVP of R&D. Pooler was VP of neuroscience and head of research in her tenure with Sangamo Therapeutics . While ElevateBio has made eye-popping financing rounds routine, Life Edit formed separate partnerships with Moderna and Novo Nordisk in quick succession last year. → Acumen Pharmaceuticals ’ regulatory affairs leader Janice Hitchcock will retire “at the end of the year,” and Amy Schacterle has been named chief regulatory officer & head of quality at the Alzheimer’s biotech. Schacterle and Acumen president/chief development officer Jim Doherty were colleagues at Sage Therapeutics — Schacterle recently left Sage as part of the latest wave of job cuts after the company said it would no longer develop zuranolone for major depressive disorder. Acumen is testing its monoclonal antibody sabirnetug in patients with early Alzheimer’s. → The latest hires at Dublin-headquartered SynOx Therapeutics are based in the US: Medical chief Elyse Seltzer held multiple roles at GSK and is the former chief development officer at UroGen Pharma , while chief commercial officer Robert Francomano was appointed to the same position at Stemline Therapeutics and Sellas Life Sciences . “We are thrilled to welcome Elyse and Robert to the SynOx leadership team as we continue to work to strategically build out our presence within the key US market,” CEO Ray Barlow said in a statement . SynOx’s $92 million Series B includes a $17 million extension from Gilde Healthcare . → MaaT Pharma has recruited Eric Soyer to succeed Siân Crouzet as finance chief. Crouzet spent the last eight years as CFO and will now be MaaT Pharma’s chief of staff. Soyer had been CFO and COO at another French biotech, Erytech Pharma . His new company’s lead program MaaT013 is in a Phase 3 study for acute graft-versus-host disease. → Frits van Alphen has replaced Gerald Parzmair as chief development officer of Memo Therapeutics , a Swiss biotech that pulled together a total of $49 million for its Series C. After eight years at Novartis , van Alphen would go on to be CMO of Vifor Pharma from 2008-13 and Swiss-based Inositec , the undercard in Vifor’s M&A spree that included Sanifit in late 2021. He also worked for Roche as global head of product development excellence in between these two CMO gigs. → Synthetic lethality player Tessellate BIO has selected Lara Boyd as CBO. Boyd had a six-year run with Takeda partner F-star Therapeutics and was elevated to VP, head of business development & corporate strategy in May 2023. Former F-star boss Eliot Forster chairs the board at Tessellate BIO, which raised $8 million in seed funding from BioGeneration Ventures and Forbion . → La Jolla, CA-based I&I biotech CalciMedica has tapped Stephen Bardin as CFO, replacing interim finance chief Daniel Geffken . Earlier this year, Peer Review covered Bardin’s departure as CFO of atai Life Sciences , a position now held by Anne Johnson . He’s also worked for Myovant Sciences as director of corporate development and BridgeBio as SVP of finance and operations. → Joe Truluck has turned in his resignation as CFO of Adial Pharmaceuticals , and Vinay Shah will replace him on Nov. 16. We told you about Shah’s last CFO appointment at Virpax Pharmaceuticals in June 2023 and he’s had the same title at Aravive . Truluck will stay with Adial as a consultant until March 31. → Claudia Lopez has joined Seattle-based breast cancer biotech Atossa Therapeutics as VP, clinical product development. Lopez led the clinical development team at another AbbVie M&A pickup , Landos Biopharma , and the 16-year Takeda vet also spent two years with Arena Pharmaceuticals . → Tony Gibney has been named chairman of the board at Clearside Biomedical , which unspooled positive Phase 2b data last month for its suprachoroidal injection of axitinib called CLS-AX in patients with wet AMD. Gibney tackled the role of chief business & strategy officer at Iveric Bio until it was sold to Astellas last year for $5.9 billion. → Radiotherapy specialist Actinium Pharmaceuticals has elected June Almenoff to the board of directors. Almenoff, a GSK alum and the ex-president/CMO at Furiex Pharmaceuticals , is also on the boards of Avalo Therapeutics and Tenax Therapeutics . → Heron Therapeutics has reserved a seat on its board of directors for Liquidia CFO and COO Michael Kaseta . Before his gig with Liquidia, Kaseta was CFO at Aerami Therapeutics and Aralez Pharmaceuticals , as well as North American CFO, global services over a decade with Sanofi .

LYON, France--( BUSINESS WIRE )--Regulatory News: MaaT Pharma (EURONEXT: MAAT – the “Company”), 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 , MaaT Pharma announced that MaaT013 batches were ready for distribution for clinical supply in the US and that MaaT Pharma advanced the readiness phase for the initiation of clinical activities. In October 2024 , MaaT Pharma 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) ( NCT04769895 ). MaaT033 In hemato-oncology: In July 2024 , the Company announced that the DSMB completed its first safety assessment of the Phase 2b trial PHOEBUS ( NCT05762211 ), 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 position 1 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 2024 1 MaaT Pharma 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 2023 1 . This trend is a direct reflection of the continued demand from the medical community for MaaT Pharma’s drug candidate MaaT013. Management Changes Eric Soyer was appointed Chief Financial Officer of MaaT Pharma 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 MaaT Pharma, Eric successfully conducted as CFO & COO of Erytech Pharma, a French 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 MaaT Pharma in its next stage of development. Eric Soyer, CFO of MaaT Pharma stated: “ I am thrilled to join the team of MaaT Pharma at this transformational moment for the Company. MaaT Pharma 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 MaaT Pharma’s continued success and to fully realize the potential of its therapeutic platform globally.” After 8 years as CFO, Siân Crouzet will become Chief of Staff to fully support a smooth transition of functions to Eric over the coming months. In her tenure, Siân 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. Siân was instrumental in the numerous financing operations accomplished since 2016, totaling more than EUR 115 million, including the Company’s successful IPO on Euronext Paris in November 2021. Siân Crouzet, CoStaff of MaaT Pharma stated: “ 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. At this juncture, it is the right time from a professional and personal perspective for me to hand over the reins to take MaaT Pharma to the next stage of its development.” Hervé Affagard, CEO and co-founder of MaaT Pharma added: “ 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. MaaT Pharma 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 Siân 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.” Upcoming investor and medical conferences participation November 6-8, 2024 – 39 th SITC annual meeting in Houston, USA November 20-22, 2024 – SFGM-TC annual meeting in Toulouse, France November 25-27, 2024 – Deutsches Eigenkapitalforum annual meeting​​ in Frankfurt, Germany November 26, 2024 – Investir Day event in Paris, France. December 5, 2024 – 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 MaaT Pharma MaaT Pharma 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, MaaT Pharma is leading the way in bringing the first microbiome-driven immunomodulator in oncology. Using its proprietary pooling and co-cultivation technologies, MaaT Pharma develops high diversity, standardized drug candidates, aiming at extending life of cancer patients. MaaT Pharma 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’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 Unaudited data