Flamel Technologies SA

GHENT, Belgium--( BUSINESS WIRE )-- MRM Health NV, a clinical-stage biopharmaceutical company developing innovative therapeutics for inflammatory, CNS and metabolic diseases, today announced the appointment of Grégoire Franoux, M.B.A., to the newly created role of Chief Business Officer. Concurrently, the company has strengthened its Board of Directors with the appointment of industry veteran Ron Robison, M.D. “ We are excited to have Grégoire join our executive team at this pivotal moment for MRM Health, on the cusp of late-stage clinical development for our lead candidate MH002 in ulcerative colitis and pouchitis, from our proprietary CORAL platform designed to harness the full power of the gut microbiome to develop effective and safe therapeutics,” said Sam Possemiers, Ph.D., Chief Executive Officer of MRM Health. “Grégoire’s extensive expertise in corporate development, combined with his strategic acumen, will be crucial as we continue to advance our pipeline and expand our reach. ” Mr. Franoux will lead the company’s business development and corporate strategy, focusing on forging strategic partnerships and driving growth. He brings 20 years of experience in strategic planning, licensing, business development and corporate finance within the biotechnology sector. He joins MRM Health from Belfius Bank, where he was spearheading Corporate Finance and Capital Markets activities in the Life Sciences sector. Prior to joining Belfius, Gregoire held senior business development positions at Oxurion, Gruenenthal GmbH and Flamel Technologies. He holds an M.S. in Biotechnology from ESIEE Paris, an M.S. in International Finance from IAE Aix-Marseille, and an Executive M.B.A. from INSEAD. “ It is an exciting time to join the MRM Health team as the company makes important progress advancing next-generation LBPs for inflammatory, CNS and metabolic diseases. I look forward to optimizing the value of MRM’s potentially life-altering therapies and delivering them to patients in need ,” commented Grégoire Franoux. In addition, MRM Health welcomes Ron Robison, M.D., to its Board of Directors. Ron, who previously served as Vice President at AbbVie, brings over three decades of experience in drug development and commercialization. Ron also served in global senior pharmaceutical R&D leadership roles at several organizations, including Mallinckrodt Medical, Sanofi/Sterling Winthrop, Nycomed, Amersham Health, Abbott and Head of R&D and Chief Medical Officer at Solvay Pharmaceuticals. Ron has overseen the approval of more than 20 new molecular entities worldwide with over ten innovative clinical indications obtained under FDA breakthrough therapy designation. Dr. Robison holds an M.D. from the Oregon Health Sciences University, an M.S. in Medical Informatics/Biomedical Engineering from the University of Utah, and a B.S. from Oregon State University. MRM Health Chairman Werner Cautreels added, “ We are thrilled to have Ron join our Board. His deep industry knowledge and experience progressing assets through clinical and global regulatory development will be invaluable as we continue to grow and develop potentially transformative therapies. ” -Ends- About MRM Health MRM Health is a clinical-stage biotech developing innovative therapeutics for inflammatory, CNS and metabolic diseases. The Company’s most advanced program MH002 is in preparation for pivotal clinical development in Ulcerative Colitis and/or in the orphan disease indication Pouchitis. MRM Health leverages its proprietary disruptive CORAL ® technology platform to design microbiome-based biotherapeutics, based on disease-focused specific combinations of 5 to 10 live gut bacteria, and to optimize them for faster onset-of-action and increased potency and robustness. A significant differentiator is the ability to manufacture these consortia as single drug substance in a single standardized, scalable and highly cost-effective process. In addition to the program in Inflammatory Bowel Diseases, MRM Health has ongoing preclinical programs in Parkinson’s Disease and Spondyloarthritis, and partnered programs with IFF in Type 2 Diabetes and NAFLD. For more information, please visit the website at www.mrmhealth.com .

Completed a technology transfer, submitted a new manufacturing file to the United States ("U.S.") Food and Drug Administration ("FDA"), and released new drug produced with processes designed to support commercial-stage manufacturing of a Phase 3 investigational drug On track to report data from ongoing Phase 2 clinical trial of NRX-101 in patients with bipolar depression with sub-acute suicidal ideation and behavior (SSIB) in 1Q 2023 Company has received numerous partnering inquiries for NRX-101 Plan to initiate registrational Phase 3 clinical trial of NRX-101 in patients with bipolar depression with acute suicidal ideation and behavior (ASIB) by year-end; data readout expected in 3Q 2023 Commenced Phase 2 clinical trial planning of NRX-101 for post-traumatic stress disorder ("PTSD") Ended quarter with $18.2 million in cash and cash equivalents and announced completion of a subsequent unsecured debt financing on November 7, 2022, providing net proceeds of $10.0 million to support the NRx Pharmaceuticals' pipeline of life-saving therapeutics RADNOR, Pa., Nov. 14, 2022 /PRNewswire/ -- NRx Pharmaceuticals, Inc. (Nasdaq: NRXP) ("NRx Pharmaceuticals", the "Company"), a clinical-stage biopharmaceutical company, today announced its financial results for the third quarter of 2022 and provided a business and clinical update. Continue Reading "In recent months, NRx Pharmaceuticals has made substantial progress advancing our clinical development plans for our lead investigational compound, NRX-101, in multiple psychiatric indications," said Stephen Willard, J.D., Chief Executive Officer and Director of NRx Pharmaceuticals. "Today, someone in the U.S. someone attempts suicide every 27 seconds, and someone dies of suicide every 11 minutes and there is no approved medication for suicidal bipolar depression or PTSD. The only FDA-approved treatment for suicidal bipolar depression remains electroshock therapy. The FDA has granted NRX-101 a Breakthrough Therapy Designation with an accompanying Special Protocol Agreement for treatment of patients with bipolar depression and acute suicidality. If approved, we aim to offer this potentially transformative medicine to patients in 2024. During this exciting time at NRx Pharmaceuticals, we remain committed to our mission of meeting the needs of underserved patients with life-threatening central nervous system ("CNS") disorders." NRx Pharmaceuticals Reports Third Quarter 2022 Financial Results and Provides Business Update Tweet this NRx Pharmaceuticals plans to advance NRX-101 to approval with multiple near-term catalysts on track for the fourth quarter, including the initiation of a Phase 2b/3 SPA trial (a registrational Phase 3 clinical trial) for NRX-101 in patients with bipolar depression with acute suicidality and a Phase 2 trial for NRX-101 in PTSD, a secondary indication recently announced in September. Additionally, the Company expects to report top-line clinical data for the Phase 2 trial of NRX-101 in patients with bipolar depression with sub-acute suicidality in the first quarter of 2023. Third Quarter Clinical and Regulatory Highlights In March 2022, NRx Pharmaceuticals announced a primary focus on its psychiatry franchise and the late-stage development of NRX-101 for the treatment of bipolar depression in patients with suicidality. NRX-101 is a fixed dose combination of D-cycloserine, an NMDA antagonist, and lurasidone, a 5-HT2A atypical antipsychotic and antidepressant, for the maintenance of remission from severe bipolar depression following initial stabilization with ketamine. The previously undiscovered synergy between these two drug classes in the treatment of CNS disorders, combined with the efficacy of D-cycloserine in the treatment of depression and PTSD, is the subject of 47 issued patents and more than 43 pending patents owned by or licensed to NRx Pharmaceuticals. NRX-101 Lead Indication – Severe Bipolar Depression in Patients with Acute Suicidal Ideation and Behavior (ASIB) After Initial Stabilization with ketamine In 2017, NRX-101 received an investigational new drug (IND) clearance by the U.S. Food and Drug Administration (FDA) and a Phase 2b/3 clinical trial commenced for bipolar depression with ASIB. Later that year, the FDA granted NRX-101 a Fast Track designation for the same indication. In 2018, the FDA provided a Letter of Support to the Company encouraging the development of Glutamine+Glutamate (Glx) as a pharmacodynamic biomarker for depression. The letter referenced published and unpublished data demonstrating a significant association between clinical symptoms of depression and levels of brain Glx. In the STABIL-B Phase 2 trial, the Phase 2 portion of the Phase 2b/3 trial, patients with bipolar depression and ASIB received either NRX-101 or lurasidone after an intravenous infusion of NRX-100 (ketamine). The proof-of-concept data presented at the American Congress of Neuropsychopharmacology in 2018 demonstrated with statistical significance that NRX-101 treated patients experienced lower depression scores and did not relapse. Based on STABIL-B findings, the FDA granted NRX-101 Breakthrough Therapy Designation and a Special Protocol Agreement ("SPA") for bipolar depression in patients with ASIB, which affects ~150K-180K patients per year in the U.S. The Breakthrough Therapy Designation allows for an expedited rolling submission of a new drug application ("NDA") for investigational drugs that have demonstrated substantial improvement over existing approved therapies, and the SPA allows for a single registrational trial of NRX-101 in severe bipolar depression in patients with ASIB after stabilization with ketamine, using a protocol similar to the STABIL-B trial with a patient population of less than 100. NRx Pharmaceuticals plans to initiate the registrational Phase 3 portion of the Phase 2b/3 clinical trial of bipolar depression in patients with ASIB in 4Q 2022. The trial is designed as a double-blind, adaptive trial with a 2:1 randomization of NRX-101 vs. lurasidone alone in 72 patients. The study is expected to find that following initial stabilization with a single infusion of ketamine (NRX-100), treatment with NRX-101 is superior to lurasidone alone in maintaining remission from symptoms of depression and suicidality as measured by the MADRS-10 depression scale and the CGI suicidality scale. NRx Pharmaceuticals announced that it has transferred Phase 3 commercial drug manufacturing processes to the U.S. and released Phase 3 drug manufactured via the expected commercial-stage processes. NRx Pharmaceuticals has submitted its manufacturing file to the FDA. This investigational drug manufactured according to these new processes will be used in the upcoming Phase 3 trial. A data readout from the registrational Phase 3 clinical trial is expected in 3Q 2023. Assuming that efficacy endpoints and safety are met, NRx Pharmaceuticals plans to initiate submission of a NDA to the FDA by year-end 2023, as allowed under Breakthrough Therapy Designation. Company has received numerous partnering inquiries for NRX-101 NRX-101 Indication – Bipolar Depression in Patients with Sub-acute Suicidal Ideation and Behavior (SSIB) A Phase 2 double-blind study completed in 2018 demonstrated the ability of NRX-101 to improve depression and suicidality over 6 weeks when taken twice daily over lurasidone alone after an initial stabilization with ketamine. The current study involving patients with bipolar depression and sub-acute suicidality (not requiring hospitalization) does not include the use of ketamine; all patients are being treated in an outpatient setting. Insights from this study will guide NRx Pharmaceuticals in the potential expansion of the indication for NRX-101 to bipolar depression with SSIB, which represents a significantly 2-3x larger patient population than those with bipolar depression and ASIB. A data readout of this study is expected by 1H 2023. NRX-101 Indication – Post Traumatic Stress Disorder In September 2022, NRx announced plans to investigate PTSD as an additional indication. The Company expects to commence Phase 2 clinical trial planning of NRX-101 in PTSD in 4Q 2022. Depression in PTSD may be driven by pathways that are similar to those that drive depression in other conditions (NMDA and 5-HT2A). Additionally, approximately 10% of patients with PTSD may experience suicidality, especially those with severe PTSD. In a preclinical PTSD study, D-cycloserine, a component of NRX-101, demonstrated the ability to extinguish recurring images of traumatic events, also known as fear memory, in a validated WKY model of PTSD. Corporate Updates In August 2022, the Company appointed Mr. Willard as Chief Executive Officer and as a member of the Board of Directors. Mr. Willard brings a wealth of experience in the management of publicly traded biotechnology companies, together with his background in law and finance. Most recently, Mr. Willard previously served as CEO of Cellphire Therapeutics, where he grew the company and shepherded their revolutionary human platelet platform through key clinical trials, growing the company and enhancing shareholder value. For eight years prior to that he served as CEO of NASDAQ traded Flamel Technologies. Completed agreement with Relief Therapeutics Holding SA regarding pending litigation. Further information was contained in a joint press release issued on November 13, 2022, and will be included in the form 8-K to be filed with the Securities and Exchange Commission upon settlement. Third Quarter 2022 Financial Results Financial Results for the Third Quarter ended September 30, 2022 Research and development (R&D) expenses for the third quarter totaled $4.1 million compared to $6.3 million for the comparable quarter in 2021. The decrease in R&D expenses related primarily to a decrease clinical trials and development expenses related to ZYESAMI®. General and administrative (G&A) expenses for the third quarter totaled $5.0 million compared to $13.8 million for the comparable quarter in 2021. The decrease in G&A expenses was primarily related to a decrease in stock-based compensation and consultant fees. Other income for the third quarter totaled $0.06 million compared to $17.0 million for the comparable quarter in 2021. The decrease in other income was primarily related to a decrease in the fair value of certain Substitute Warrants and the Placement Warrants assumed pursuant to the Merger Agreement because of lower stock price levels. Net loss for the third quarter was $9.1 million compared with a net loss of $37.0 million for the comparable quarter in 2021. Financial Results for Nine Months ended September 30, 2022 R&D expenses for the nine months ended September 30, 2022, totaled $12.6 million compared to $13.8 million for the nine months ended September 30, 2021. The decrease in R&D expenses related primarily to a decrease in regulatory and process development expenses related to ZYESAMI® and the BriLife vaccine. G&A expenses for the nine months ended September 30, 2022, totaled $21.9 million compared to $28.4 million for the nine months ended September 30, 2021. The decrease in G&A expenses was primarily related to a decrease in consultant fees and stock-based compensation. Settlement expenses for the nine months ended September 30, 2022, totaled $0.0 million compared to $21.4 million for the nine months ended September 30, 2021, related to the GEM Warrant reflecting the incremental value through the date of issuance. Other income for the nine months ended September 30, 2022, totaled $4.9 million compared to $0.2 million for the nine months ended September 30, 2021. The increase in other income was primarily related to a decrease in the fair value of the Earnout Cash liability compared to the nine months ended September 30, 2021. Net loss for the nine months ended September 30, 2022, was $29.5 million compared with a net loss of $62.7 million for the nine months ended September 30, 2021. As of September 30, 2022, cash was $18.2 million compared to $27.6 million as of December 31, 2021. NRx Pharmaceuticals announced completion of a subsequent unsecured debt financing on November 7, 2022, with net proceeds of $10.0 million. The Company intends to use the net proceeds to support its NRX-101 development programs for the treatment of suicidal bipolar depression and PTSD. The Company believes that it has sufficient funds to support our ongoing clinical development plans for at least the next 12 months, and if necessary, the ability to reduce non-core G&A operating expenses. Conference Call and Webcast Details A live webcast of the conference call will be available on the Company's website at NRx Pharmaceuticals Third Quarter Earnings Webcast/Call. An archive of the webcast will be available on the Company's website. Participants that are unable to join the webcast can access the conference call via telephone by dialing domestically +1 (833) 630-1956 or internationally +1 (412) 317-1837. About NRX-101 Up to 50% of individuals with bipolar disorder attempt suicide over their lifetime, and estimates indicate that up to 20% may succumb to suicide. The only FDA-approved treatment for patients with bipolar depression and acute suicidal ideation & behavior (ASIB) remains electroconvulsive therapy (ECT). Conventional antidepressants can increase the risk of suicide in certain patients; hence their labels contain a warning to that effect. NRX-101 is a patented, oral, fixed dose combination of D-cycloserine and lurasidone, neither of which has shown addiction potential. Based on the results of a Phase 2 proof-of-concept study, NRX-101 received Breakthrough Therapy Designation from the FDA for the treatment of severe bipolar depression in patients with ASIB after initial stabilization with ketamine or other effective therapy. NRX-101 is one of the first oral antidepressants currently in late-stage clinical studies targeting the NMDA-receptor in the brain, which represents potentially a key new mechanism to treat depression with and without suicidality, as well as PTSD and other indications. To date, NRX-101 is the only oral NMDA investigational medicine focused on bipolar depression in patients with acute and sub-acute suicidality. NRx Pharmaceuticals expects to begin its registration trial for NRX-101 under a SPA in 4Q 2022 or early Q1 2023. About NRx Pharmaceuticals NRx Pharmaceuticals is a clinical-stage biopharmaceutical company developing therapeutics for the treatment of central nervous system disorders, specifically suicidal depression and post-traumatic stress disorder (PTSD). The company's lead program NRX-101, an oral, fixed-dose combination of D-cycloserine and lurasidone, targets the brain's NMDA receptor and is being investigated in a Phase 3 trial under a Food and Drug Administration ("FDA") Special Protocol Agreement and Breakthrough Therapy Designation in patients with bipolar depression and acute suicidal ideation, an indication for which the only approved treatment is electroshock therapy. NRx Pharmaceuticals has also initiated a Phase 2b clinical trial in patients with Sub-Acute Suicidality, potentially a substantially broader indication. The Breakthrough Therapy Designation and Special Protocol Agreement were awarded by the FDA based on the Company's prior STABIL-B trial that demonstrated substantial improvement over available therapy in reducing depression and suicidality compared to placebo when patients were treated with NRX-101 after a single dose of ketamine. Cautionary Note Regarding Forward-Looking Statements This announcement of NRx Pharmaceuticals, Inc. includes "forward-looking statements" within the meaning of the "safe harbor" provisions of the U.S. Private Securities Litigation Reform Act of 1995, which may include, but are not limited to, statements regarding our financial outlook, product development, business prospects, and market and industry trends and conditions, as well as the Company's strategies, plans, objectives, and goals. These forward-looking statements are based on current beliefs, expectations, estimates, forecasts, and projections of, as well as assumptions made by, and information currently available to, the Company's management. The Company assumes no obligation to revise any forward-looking statement, whether as a result of new information, future events or otherwise. Accordingly, you should not place reliance on any forward-looking statement, and all forward-looking statements are herein qualified by reference to the cautionary statements set forth above. CORPORATE CONTACT Molly Cogan Sr. Director, Global Communications [email protected] INVESTOR RELATIONS Suzanne Messere Investor Relations [email protected] The accompanying notes are an integral part of these unaudited condensed consolidated financial statements. The accompanying notes are an integral part of these unaudited condensed consolidated financial statements. SOURCE NRx Pharmaceuticals, Inc.

→ Dave Greenwald ’s days as acting CEO of Apertura Gene Therapy are over as Joseph La Barge steps in to lead the biotech, which just launched in April. Peer Review had been wondering about La Barge’s next landing spot since he left Spark at the end of 2021. In his eight-year stretch with the gene therapy pioneer, he began as chief legal officer and was later promoted to CBO in 2019, when Spark was sold to Roche for $4.3 billion. Deerfield , where Greenwald is VP of business development, put up all the financing for Apertura’s $67 million Series A. → Big Pharma vet Martin Munte has been named CEO of Swiss biotech Vaccentis , the maker of such therapies as Reniale for non-metastatic renal cell carcinomas. After two years at Roche, Munte spent seven years in marketing at AstraZeneca , then moved to Amgen in 2009, where he stayed for the next 12 years. He held general manager positions in Slovakia and Turkey before becoming Amgen’s external access engagement lead, Europe in 2019. Munte’s appointment follows the arrival of three board members in May: Marcel Frei , Subhasis Roy and new chairman Matthias Oertle . → London infectious disease biotech Centauri Therapeutics , which pulled together a $24 million Series A with the help of Boehringer Ingelheim and Evotec , has selected Jennifer Schneider as CEO and Helen Bright as VP of R&D. Schneider is the former executive officer for the Global Antibiotic R&D Partnership (GARDP) North America, while Bright — an ex-senior principal scientist at Pfizer and an AstraZeneca vet in virology and vaccines discovery — spent the last year as head of infection biology at Medicines Discovery Catapult . → We filled you in on Gil Labrucherie ’s departure from a tumbling Nektar , and he’s turned up as CFO of Los Angeles-based Acelyrin , Shao-Lee Lin ’s biotech that hit the jackpot with a $250 million Series B led by the folks at Westlake Village BioPartners . Labrucherie, who gets started July 18, joined Nektar in 2005 as SVP and general counsel, and was promoted to COO and CFO in May 2016. If you haven’t read them already, Endpoints News ‘ Kyle LaHucik profiled Lin along with 14 other LGBTQ biopharma leaders last month. → With Chris Morabito out as CMO of Fulcrum Therapeutics , R&D chief and ex-Roche global clinical development lead Judith Dunn will mind the store until a successor is named. Morabito came to Fulcrum last year after serving in the same capacity at Cardurion Therapeutics . Fulcrum has pushed the onetime GSK drug losmapimod into Phase III for facioscapulohumeral muscular dystrophy after a Phase II bust in August 2020, and shares spiked a year later when early data for its sickle cell program achieved statistical significance. → Hal Barron over at Altos Labs is plucking up Herbert “ Skip ” Virgin as CMO of the company’s Altos Institute of Medicine. Virgin is skipping out on his CSO post at Vir Biotechnology to join Rick Klausner’s new anti-aging outfit and is teaming up with the likes of CRISPR pioneer Jennifer Doudna . Prior to Vir, Virgin spent most of his career in academia, serving on the faculty of Washington University School of Medicine from 1990 to early 2019. → SpyBiotech co-founder, president, CEO and CSO Sumi Biswas has relinquished one of her titles, setting the stage for Mark Leuchtenberger to take over as chief executive. Leuchtenberger has led the charge at several companies, including CEO stints at Chiasma , Rib-X Pharmaceuticals (now Melinta ) and Brooklyn ImmunoTherapeutics . Under Biswas’ guidance, SpyBiotech teamed up with the Serum Institute of India on a Covid-19 vaccine trial and netted a $32.5 million Series A five months later. → The hits just keep on coming at CytomX as the biotech grapples with a Phase II dud from one of its lead drugs, praluzatamab ravtansine , in breast cancer. Sean McCarthy ’s crew is shrinking by 40% and the C-suite hasn’t been spared: President and COO Amy Peterson , CFO Carlos Campoy and CMO Alison Hannah have all been shown the door. With the reduced headcount, the South San Francisco biotech hopes to have enough cash on hand to last until 2025. → Jackie Fouse will pass the baton to Brian Goff at Agios on Aug. 8, ending a three-year run as chief executive that saw the company turn away from oncology and reinvent itself as a rare disease outfit. Fouse rejected the notion of being a CEO again in an interview with Endpoints News , but she’ll stay on as chair, while her predecessor and GV general partner David Schenkein will keep his seat on the board after two years as chairman. Goff has plenty of Big Pharma credentials with 21 combined years of service at Novartis and J&J , and he’s also been chief commercial and global operations officer at Alexion from 2017-21. → After company shares took a nosedive in May following news that its Covid-19 treatment had more deaths in the treatment group than placebo cohort in its NIH study and the resignations of its CFO and chief corporate officer, NRx Pharmaceuticals is trying to restore some semblance of balance to the company with the appointment of Stephen Willard as CEO. Willard assumes the reins from interim CEO Robert Besthof , who will return to his duties as head of operations and CCO. No stranger to the CEO hat, Willard has served as chief executive at Cellphire Therapeutics and Flamel Technologies (now Avadel Pharmaceuticals ). Earlier in his career, Willard was an associate director at the FDIC. → To say it’s been a bumpy ride for CytoDyn would be an understatement. After being slapped with two clinical holds in March following an RTF and some stern warnings, the company has now appointed Cyrus Arman as president — who will eventually transition to CEO in the next six months — in hopes of righting the ship. Arman takes over from interim president Antonio Migliarese , who will resume his duties as CFO. Arman comes aboard from Nimble Therapeutics , where he served as CBO. Prior to that stint, Arman was with Neuvogen (VP of corporate development and strategy) and Amgen . → In January, we shared that OSE Immunotherapeutics chair Dominique Costantini was pinch-hitting as CEO after Alexis Peyroles ’ departure, and this week Alexis Vandier has stepped up to the plate as OSE’s permanent chief exec. Vandier climbed through the ranks during his 12 years at Ipsen , getting elevated to VP – global asset lead, oncology in early 2021. In Vandier’s string of posts at Ipsen, the new buyer of Epizyme for $247 million , the 11-year Sanofi vet was general manager of Ipsen France and SVP, global consumer healthcare strategy. → Frank Glavin has succeeded co-founder Marty Moore as CEO of Redwood City, CA’s Meissa Vaccines , while Moore becomes the company’s CSO. Galvin was previously the chief executive of Orphan Technologies , which was sold to Martin Shkreli ’s old company Travere Therapeutics for $90 million upfront when it was still Retrophin in October 2020. Meissa is in a Phase Ic trial for its intranasal RSV vaccine candidate MV-012-968 and also has an intranasal Covid-19 vaccine hopeful in Phase I. → Staring at an FDA delay for tislelizumab with no hint of a reschedule, BeiGene has made several moves. Batting leadoff, Chan Lee ’s first day as general counsel of BeiGene will be Monday as he takes over for Scott Samuels , who had been with the biotech for five years. Lee bids farewell to Sanofi after his stint as North America general counsel, and from 2008-2016 he held multiple legal posts at Pfizer, including SVP and chief counsel for the drug giant’s Innovative Health global business. Additionally, BeiGene has promoted Shreya Jani to SVP, corporate affairs (ex-Greater China) and tapped Michael Schoen to lead US government affairs & public policy. Jani came on board as VP last June, and to round out 14 years at Pfizer in 2017, she was the Big Pharma’s VP, corporate affairs, vaccines, oncology and consumer healthcare. Schoen will continue to be CEO John Oyler ’s chief of staff along with his duties as SVP of business operations. → At Israeli oncology player Purple Biotech , there’s a new but familiar face at the top. Gil Efron , the president and CFO for the last year and a Purple Biotech exec since 2018, has succeeded Isaac Israel , who cited personal reasons for his exit. Purple Biotech is testing its monoclonal antibody CM24 as a combo therapy with Bristol Myers Squibb ’s Opdivo . → Staying in London, Karen Miller has signed on as CSO of Ixaka , a cell and gene therapy player tackling chronic limb-threatening ischemia in Phase III. Miller comes to Ixaka after three years as SVP, pipeline research with Adaptimmune , and she was previously the head of the immunology innovation fund at GSK. The company once known as Rexgenero lined up a $54 million (£40 million) haul in January 2021. → Shortly after bringing in Marshelle Smith Warren as CMO, cell therapy outfit SQZ Biotechnologies has bumped up Morgan Stanley alum Micah Zajic to CFO. Zajic, the CBO at SQZ since October 2020, served as senior director, corporate strategy with Alexion before jumping to MeiraGTx as VP of corporate development from 2017-20. During a flurry of similar appointments at the dawn of 2022, ex- Alnylam chief John Maraganore teamed up with SQZ as a strategic advisor. → One year to the day after Brii Bio ’s $320 million IPO on the Hong Kong exchange, the biotech with HBV and HIV candidates in the pipeline has appointed Susannah Cantrell as CBO. Cantrell’s background includes stops at such major players as GSK, Genentech and Gilead , where she was head of global commercial strategy and marketing oncology. Since November 2020, she had filled the roles of CBO and later COO at Second Genome . → Good as Gold: Part of Merck ’s increasing interest in AI with a deal worth up to $610 million plus royalties, Absci has enlisted Denise Dettore as chief people officer and Jack Gold as chief marketing officer. Following her time at Genentech and Jazz Pharmaceuticals , Dettore recently took on the roles of VP, human resources for North America, Europe and new markets and co-global head of human resources at BeiGene. Gold had a long run in marketing at Nike from 1997-2018, and then became chief marketing officer of Zymergen before leaving in January. → Now that we have AI on our minds, GSK partner PathAI has recruited Brandon Eldredge as CFO. He jumps to the AI pathology upstart from Mass General Brigham, where he was chief clinical business officer, and before it rebranded to Syneos Health , Eldredge served as SVP of corporate strategy and development at inVentiv Health . Although financial specifics were scant, PathAI and GSK are going after oncology and NASH in a new pact that was announced in April. → With new CEO Stephen Yoo in place , Anjarium Biosciences has fleshed out its C-suite with Samantha Vieira as COO and Nate Massari as CBO. Vieira moves on to Anjarium from Biogen , where she was global product development and commercial lead, retinal gene therapy after the ill-fated alliance with Nightstar . Massari co-founded Rumpus Therapeutics and was EVP of rare disease operations at Aytu BioPharma before the Swiss gene therapy biotech came calling. Anjarium assembled big-name investors like Abingworth and Pfizer for its $61 million Series A in September 2021. → Lynette Herscha has reunited with CEO Amanda Wagner as COO of I/O biotech Immunitas Therapeutics , which is targeting CD161 with IMT-009 . The pair worked at Concert Pharmaceuticals — Herscha as associate general counsel, Wagner as VP, business development & product strategy — when the biotech inked a $250 million CF deal with Vertex in 2017. Since her days at Concert, Herscha served as chief legal officer and corporate secretary with Solid Bio and Senda Biosciences . → After a 17-year stint as general counsel of Gilead, Brett Pletcher is retiring , and Deborah Telman , who hops aboard from women’s health pharma and Merck spinout Organon , is taking over. Telman served as general counsel of Organon and has previously held roles at Sorrento Therapeutics , Johnson Controls and Abbott , among others. → Taking an AI approach to developing cancer drugs, Houston’s Kiromic BioPharma has elevated Leonardo Mirandola to CSO. Mirandola has been part of the Kiromic crew since 2016, when he was executive director of R&D. He then rose to head of clinical translation in 2020 and VP of R&D and clinical translation a year later. Kiromic’s stock has lost 96% of its value since joining Nasdaq during the golden age of IPOs in 2020. → South San Francisco-based Amgen spinout Kezar Life Sciences has locked in Nick Mordwinkin as CBO. Leaving Gilead after nearly a year as head of corporate development, inflammation and fibrosis, Mordwinkin once held the role of senior director, head of corporate strategy at Ultragenyx . Kezar’s lead drug, zetomipzomib , fell flat in a Phase II study for patients with dermatomyositis and polymyositis in May. → Swiss-based Anaveon , which raked in $119 million in the hunt for a better next-gen IL-2, has plucked up Gary Phillips as CBO. Phillips most recently served as president and CEO of Orphomed . Phillips has also served as EVP, chief strategy officer, and president, autoimmune & rare diseases at Mallinckrodt Pharmaceuticals and had stints at Reckitt Benckiser Pharmaceuticals , Bausch & Lomb , Merck Serono , Novartis and Wyeth . → jCyte is making the rounds again in Peer Review. This time bringing in Stewart Craig as chief technology officer. Craig joins the Newport Beach, CA-based company from Erytech Pharma , where he served as chief technical officer. Prior to that, Craig had gigs at Orchard Therapeutics (chief manufacturing officer), Sangamo (SVP, technical operations), PT Cell Therapy Services and Xcyte Therapies (COO). → Suzanne Foster is joining the ranks of Beckman Coulter Life Sciences as president, succeeding Greg Milosevich who is moving on to greener pastures at Danaher Corporation . Foster previously served as president of healthcare at Stanley Black & Decker and had a 10-year stint at Medtronic as general manager of their advanced energy business. → Palo Alto, CA-based Immune-Onc Therapeutics has brought in Christopher Whitmore as CFO. Whitmore hails from Notable Labs , where he served in the same role. Before that, Whitmore was VP of finance and administration for Harpoon Therapeutics . Whitmore also has experience under his belt from stints at Immune Design , AcelRx Pharmaceuticals , Sangamo Therapeutics and KPMG LLP . → InVivo Therapeutics — which last made headlines in 2017 after reporting a third patient being treated with its spinal cord implant had died — has promoted Heather Hamel to chief legal officer and general counsel. Hamel previously served as the company’s VP of legal affairs and business development. Prior to joining InVivo, Hamel was with Ecolab and PLR IP . → New York-based gamma delta T cell shop IN8bio has installed Big Pharma alum Kenneth LaMontagne as SVP, business development. LaMontagne had a nine-year run at Novartis that concluded as global head of business insights, cell & gene therapies unit, and in Bristol Myers’ business development leadership, he led the search & evaluation team for the pharma giant’s cell therapy franchise. In April, LaMontagne left his post as VP, business development with Artisan Bio . → Robert Glassman has been named EVP, search & evaluation of Enavate Sciences , a biotech investment group from Patient Square Capital that kicked things off with $300 million in early May. The ex-vice chairman of global health care investment banking for Credit Suisse , Glassman had made a return engagement to OrbiMed , spending the last year and a half as a venture partner in public equity. → Never too late, we suppose: Swedish kidney disease biotech Calliditas ended 2021 with a flourish by gaining accelerated approval for Tarpeyo , a drug that cuts down proteinuria in patients with primary IgA nephropathy. Calliditas has also announced a pair of moves that were curiously made a while ago. Sandra Frithiof has been head of human resources since departing from Ramberg Advokater in May 2020, and ex- Goodwin Procter partner Jonathan Schur joined as group general counsel in October of that same year. → News from the land down under: Sydney-based antibiotics biotech Recce Pharmaceuticals has appointed Philip Sutton as VP of translational sciences. Sutton has worked with Recce before on its clinical advisory committee and as head of the H. pylori development program, and for the last decade, Sutton led the mucosal immunology group at Murdoch Children’s Research Institute in Melbourne. → CRISPR startup Spotlight Therapeutics is looking to shine brighter by electing Enhertu luminary Antoine Yver to the board of directors. Yver, the current chairman of development at Centessa , is a new board member at Sanofi — underscoring the Big Pharma’s oncology ambitions — and was Daiichi Sankyo ’s global head of R&D from 2016-21. → Industry vet Susanne Schaffert — who was cut out of a job at Novartis along with her colleague John Tsai as part of a major reorganization effort at the pharma giant — has hopped onto the board of directors of Rubius Therapeutics right as Anne Prener is making her exit from the board. Schaffert spent the last 27 years at Novartis Oncology, culminating in her role as president. Earlier in her career, Schaffert held a number of roles with Novartis, including region head, Novartis Oncology Europe; head of investor relations and global franchise head for immunology and transplantation. → David Chang ’s crew at Allogene has brought Xencor co-founder Stephen Mayo into the fold, opening up space for him on the board of directors. Mayo holds board seats at Merck and Sarepta , and has taught at Caltech for the last 30 years. → Third Rock venture partner Lorence Kim has claimed a spot on the board of directors at one of the VC’s startups, Revolution Medicines . Kim was with Goldman Sach s for 14 years before heading to Moderna as CFO from 2014-20, and he’s a board member at Cowen , Flare Therapeutics and Abata Therapeutics . → Nello Mainolfi ’s protein degradation shop Kymera Therapeutics has pulled up a chair for ex-Gates Foundation COO Leigh Morgan on the board of directors. Morgan, the chief strategy and operating officer for Nia Tero , is the former global head of human resources for product development at Genentech. → We told you about Pam Stetkiewicz joining Arbor Biotechnologies last summer as COO, and she’s just picked up a board seat at ImmuneID , an antibody upstart from Longwood and Harvard’s Stephen Elledge . Stetkiewicz, a 13-year NIBR veteran and former Editas Medicine exec, left for Arbor after a year as SVP, global program leader at Flagship . → Struck down unanimously by an FDA adcomm and handed a CRL a couple months later for its Allport syndrome drug bardoxolone methyl , Reata has named 21-year Pfizer vet Steven Ryder as a member of the board of directors. The one-time Alexion chief development officer has been CMO of Rallybio for three years. → Georges Gemayel , the interim CEO of Gemini after Jason Meyenburg hit the eject button in late February , has been appointed chairman of GlycoEra ’s board of directors. Luciole Medical CEO Philippe Dro and 5AM Ventures managing partner Kush Parmar have also earned seats on the board. → James Cullem ascended to interim CEO at Allarity Therapeutics a couple weeks ago, and now he’s taken a seat on the board of directors with co-founder Thomas Jensen , who shifted to the role of SVP of investor relations. Syros Pharmaceuticals CMO David Roth has also joined Allarity’s board. → San Diego-based Plexium , which has inked deals with heavyweight players such as AbbVie and Amgen , has recruited Brian Wong to its board of directors. Wong is the president and CEO of RAPT Therapeutics . Prior to his current role, Wong was with Five Prime (SVP, research and head of immuno-oncology), Roche (director in the inflammation disease biology area), and Rigel Pharmaceuticals . → Ex-Merck US oncology president Jill DeSimone has been added to the board of directors at Affini-T Therapeutics , which racked up a $175 million financing round in March. DeSimone joined the board at Praxis Precision Medicines a couple months ago. → Pfizer and Teva -partnered Alvotech is adding four new members to its board of directors with the appointments of Lisa Graver (CEO of Alvogen ); Arni Hardarson (partner at Aztiq and former deputy CEO of Alvogen); Linda McGoldrick (chairman and CEO of 2EnableHeallth ); and Ann Merchant (VP for MorphoSys ). → At the same time as securing a seed financing round to pursue the development of an ex-Sanofi molecule, Mosanna Therapeutics has elected Ben Machielse as chairman of the board. Machielse is the former CEO of Vtessse and ex-COO of Omthera Pharmaceuticals . → Mitochrondria-driven CohBar is tapping Effie Tozzo as independent director of its board. Currently, Tozzo serves as CSO of Avilar Therapeutics . Tozzo’s résumé also includes stints at Cellarity (SVP, drug development), Mitobridge (head of R&D and SVP, translational sciences), Merck, Roche, BMS, Millennium, Chiron and ErgoScience . → KAHR Medical , focused on the development of bi-functional fusion proteins, has named Jennifer Minai-Azary a member of its board of directors. Minai-Azary is the CFO of Context Therapeutics and has previously served in the same role at Millendo Therapeutics . Prior to those stints, Minai-Azary was with Parexel and Ernst & Young . → Antimicrobial proteins-focused company Lysando is pulling in Sang Jung Kim to its board of directors. Kim joins Lysando with experience from his current role as director of sales & marketing at Amicogen . Prior to Amicogen, Kim was with Novozymes . → Lyon, France-based Nosopharm is bringing in new faces to its supervisory board with the appointment of Jacques Biton (CSO of Arrakis ) as chairman and new independent members: Laurent Fraisse (former Sanofi and Evotec alum), replacing Marie-Paule Richard ; Sandra Dubos (principal at Kreaxi and former engineer at Sanofi-Aventis), replacing Gwenael Hamon ; and Martin Lauriot Prevost (co-founder of Ozyme ).