Grünenthal GmbH

AACHEN, Germany I October 22, 2024 I Today, Grünenthal announced that the first participants have been enrolled in a first-in-human Phase I clinical trial for a nociceptin (NOP) receptor agonist. The trial will include 90 healthy volunteers and aims to demonstrate a favourable safety and tolerability profile and to confirm the pharmacokinetic characteristics of the compound after single and multiple ascending doses. The results of the trial are expected in Q3 2025. “Grünenthal pioneered the research into NOP receptor agonists to deliver a unique and transformative first-in-class therapy option to millions of patients suffering from chronic pain,” says Gillian Burgess, Head of Research, Grünenthal. “With a unique mechanism of action for treating chronic pain, these molecules have the potential to deliver robust pain relief combined with an improved safety profile compared to the available standard of care.” Pre-clinical data show that NOP receptor agonists have the potential to act as potent analgesics without abuse liability. 1 Leveraging the clinical data Grünenthal obtained during the development of its NOP receptor programme, Grünenthal now brings forward a candidate that shows best-in-class potency and selectivity for the NOP receptor. These properties are predicted to provide robust pain relief in a broad range of chronic pain indications without the serious central nervous system related side effects associated with available opioids. Grünenthal’s R&D pipeline includes multiple programmes across different stages, targets, modalities, and mechanisms of action to deliver innovative treatment options for patients suffering from pain and related diseases. Recently, a Phase I clinical trial with a Glucocorticoid Receptor Modulator (GRM) has been completed. The compound is developed to provide patients with a therapy option for chronic inflammatory diseases. In addition, Grünenthal is running a Phase III clinical trial with Qutenza ® (capsaicin) 8% topical system in post-surgical neuropathic pain, aiming to expand its label in the United States. A global Phase III programme investigating the efficacy, safety and tolerability of Resiniferatoxin in patients with painful osteoarthritis of the knee is currently ongoing. About the NOP Receptor The nociceptin (NOP) receptor is a G protein-coupled receptor whose natural ligand is the 17 amino acid neuropeptide known as nociceptin (N/OFQ). 2 NOP Receptor agonists have been shown to act as potent analgesics without abuse liability in pre-clinical models. 1 Although the NOP Receptor shares some sequence identity (~60%) with the opioid receptors μ-OP (MOP), κ-OP (KOP), and δ-OP (DOP), they possess little or no affinity for opioid peptides or morphine-like compounds. Likewise, opioid receptors possess little affinity towards NOP’s endogenous ligand nociceptin. 3 About Grünenthal Grünenthal is a global leader in pain management and related diseases. As a science-based, fully integrated pharmaceutical company, we have a long track record of bringing innovative treatments and state-of-the-art technologies to patients worldwide. Our purpose is to change lives for the better – and innovation is our passion. We are focusing all our activities and efforts on working towards our vision of a World Free of Pain. Grünenthal is headquartered in Aachen, Germany, and has affiliates in 27 countries across Europe, Latin America, and the U.S. Our products are available in approx. 100 countries. In 2023, Grünenthal employed around 4,400 people and achieved revenues of €1.8 billion. More information: https://www.grunenthal.com Follow us on: LinkedIn: Grunenthal Group Instagram: grunenthal 1 Lin AP, Ko MC. The therapeutic potential of nociceptin/orphanin FQ receptor agonists as analgesics without abuse liability. ACS Chem Neurosci. 2013 Feb 20;4(2):214-24. doi: 10.1021/cn300124f. Epub 2012 Nov 6. PMID: 23421672; PMCID: PMC3582300. 2 Henderson G, McKnight AT (August 1997). “The orphan opioid receptor and its endogenous ligand– nociceptin/orphanin FQ”. Trends in Pharmacological Sciences. 18 (8): 293–300. doi:10.1016/S0165- 6147(97)90645-3. PMID 9277133. 3 Butour JL, Moisand C, Mazarguil H, Mollereau C, Meunier JC (February 1997). “Recognition and activation of the opioid receptor-like ORL 1 receptor by nociceptin, nociceptin analogs and opioids”. European Journal of Pharmacology. 321 (1): 97–103. doi:10.1016/S0014-2999(96)00919-3. PMID 9083791. SOURCE: Grünenthal Group

The weather is getting cooler, but biotech’s recovery is heating up. After a years-long wait-and-see game exhausted many industry insiders, recent signals indicate a mostly promising direction for drug developers. The third quarter, which ended Monday, was up and down, with the Yen carry trade fiasco and the typical August lull. But then came a long-awaited interest rate cut, and a mini IPO revival began. Two more rate cuts are expected by the end of the year, and more are anticipated in 2025. Nine months into the year, biotech is on track to surpass the total amount of private financing from 2023, according to a new quarterly analysis from investment bank William Blair. There have been at least 10 crossover rounds each quarter for three consecutive quarters, the first stretch of its kind since the heydays of 2021. And the proportion of extension rounds dropped in the third quarter, which “potentially” means “we have passed the peak of the financing overhang in the private markets,” according to the William Blair bankers. There were five IPOs in the third quarter, and three more are now in line, including Septerna, a Phase 1 biotech that filed Wednesday . The number of follow-on offerings and private investments in public equity slowed last quarter, but they picked up after Labor Day. The first nine months of 2024 already surpassed 2023’s totals by 34%. Biopharmas have done 189 secondary offerings, raising $33.9 billion in total proceeds year-to-date, according to William Blair. Last year’s count was 186 offerings and $25.3 billion raised. Private megarounds held steady throughout the year, as well, with 23 such financings in the first quarter, 27 in the second and 23 in the third, according to an Endpoints News tally. “Combined with improving sentiment, lower rates, and better financing window (record levels of follow-ons) — Q3’s event scoreboard was supportive for XBI and biotech funds,” Jefferies analyst Michael Yee wrote in an Oct. 1 note. For the firms funding new drugs and the next generation of startups, the money was flowing, too. In recent weeks, multiple venture capital funds announced some of the biggest biotech VC hauls ever. Bain Capital Life Sciences raised $3 billion, as did ARCH Venture Partners . Flagship Pioneering kicked off the third quarter with its own $3.6 billion pool of capital. Others included TPG ‘s $580 million, venBio’s $528 million, DCVC Bio’s $400 million and Asabys’ $200 million. One sore spot was European pharma stocks , with dips in share price at Roche (down about 6.5%), Novo Nordisk (down about 1.5%) and AstraZeneca (down about 1.5%). “Obesity remains an important theme for the sector considering the outsized moves in large caps,” the Jefferies analysts wrote Tuesday evening, citing updates from Roche’s GLP-1 pill and GLP-1/GIP injectable , and Novo’s Phase 2a CB1 program . “We think excitement and enthusiasm remain high, but performance could be more data-driven with more winners and losers as the landscape continues to evolve and mature over the coming months.” Another pain point was M&A and partnerships, which William Blair bankers characterized as “anemic” in the third quarter. Eli Lilly’s $3.2 billion purchase of Morphic Therapeutic in July was the only public company buyout of more than $1 billion during that period. There were a few other deals that could eclipse $1 billion in total value, but those are contingent on the acquirees — Jnana , Nerio and Dermavant — reaching certain milestones. Also driving M&A activity were first-generation AI biotechs and multiple commercial-stage drugmakers, including Valinor Pharma, Ironshore Therapeutics , G1 Therapeutics , Revance and Dermavant. Most of the deals have not yet closed. “We expect some pause into the election,” Yee wrote Tuesday, “but lower rates and [continued] financing (funds putting money to work) support a higher XBI as we seek to hopefully break the key $100 level.” The XBI closed on Monday, Sept. 30, at $98.80, though it had crossed the $100.00 threshold in mid-July and a few times since.

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 .