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Approximately 10% of women of reproductive age worldwide are affected by endometriosis, equating to about 190 million individuals. This substantial patient population necessitates effective treatments, propelling market demand this increasing disease prevalence is driving the market for endometriosis. LAS VEGAS, Jan. 29, 2025 /PRNewswire/ -- DelveInsight's ' Endometriosis Pipeline Insight 202 5 ' report provides comprehensive global coverage of pipeline endometriosis therapies in various stages of clinical development, major pharmaceutical companies are working to advance the pipeline space and future growth potential of the endometriosis pipeline domain. Key Takeaways from the Endometriosis Pipeline Report DelveInsight's endometriosis pipeline report depicts a robust space with 15+ active players working to develop 20+ pipeline therapies for endometriosis treatment. Key endometriosis companies such as Kissei Pharmaceutical, Mithra Pharmaceuticals, Gesynta Pharma, Jiangsu Hengrui Medicine Co., Ferring Pharmaceuticals, Hope Medicine (Nanjing) Co., Ltd, VaRi Bioscience, SWK Holdings, Ananda Developments, TiumBio, Ironwood Pharmaceuticals, Chugai Pharmaceutical, Viramal, Organon, Mitsubishi Tanabe Pharma, Antev, Foraviset, ValiRx, EpicentRx, Temple Therapeutics, Celmatix, BCI Pharma, Gynica, PrecisionLife, Flightpath Biosciences, and others are evaluating new endometriosis drugs to improve the treatment landscape. Promising endometriosis pipeline therapies such as Linzagolix, Estelle, Vipoglanstat, SHR7280, Quinagolide, HMI-115, VR103, Ovarest, MRX1, TU2670, IW-3300, AMY-109, VML 0501, OG-6219, Teverelix trifluoroacetate, Raviset, VAL301, Nibrozetone, TTX334e, IntraVagS302, IntraVagS301, FP-300, and others are under different phases of endometriosis clinical trials. In October 2024, Lisata Therapeutics, Inc. announced that it has entered into a sponsored research agreement with the University of Cincinnati to investigate Lisata's novel cyclic peptide product candidate, certepetide, in combination with bevacizumab (a VEGF inhibitor) in a preclinical animal model for the treatment of endometriosis. In October 2024, Hope Medicine Inc. announced positive results from an interim analysis of a global Phase II study, " A Randomized, Multicenter, Double-Blind, Placebo -Controlled Phase 2 Study to Evaluate the Safety and Efficacy of HMI-115 in Women with Moderate to Severe Endometriosis Associated Pain Over a 12-Week Treatment Period". HMI-115 is a monoclonal antibody that blocks the prolactin receptor. It is a first-in-class treatment for endometriosis. Notably, HMI-115 has been granted Breakthrough Therapy Designation by the National Medical Products Administration ("NMPA") in China. In May 2024, Neurocrine Biosciences, Inc. announced the initiation of its Phase I first-in-human clinical study to evaluate the safety, tolerability, pharmacokinetics, and pharmacodynamics of investigational compound NBI-1117567 in healthy adult participants. NBI-1117567 is an investigational, oral, M1/M4 (M1 preferring) selective muscarinic agonist for the potential treatment of neurological and neuropsychiatric conditions. In May 2024, TiumBio Co., Ltd. focused on discovering and developing innovative therapeutics for patients with rare and incurable diseases, announced positive topline results from its Phase 2a clinical trial of Merigolix, an oral gonadotropin-releasing hormone (GnRH) receptor antagonist, in patients with moderate to severe endometriosis-associated pain. Request a sample and discover the recent advances in endometriosis treatment drugs @ Endometriosis Pipeline Report The endometriosis pipeline report provides detailed profiles of pipeline assets, a comparative analysis of clinical and non-clinical stage endometriosis drugs, inactive and dormant assets, a comprehensive assessment of driving and restraining factors, and an assessment of opportunities and risks in the endometriosis clinical trial landscape. Endometriosis Overview Endometriosis is a condition where tissue similar to the endometrium, which lines the uterus, grows outside of it. This often occurs in the lower abdomen or pelvic region but can occasionally be found elsewhere in the body. It commonly causes pelvic pain and may lead to infertility. The condition can begin with a person's first menstrual cycle and persist until menopause. The exact cause of endometriosis remains unknown, and there is currently no way to prevent it. While there is no cure, symptoms can be managed through medications or, in some cases, surgery. Not all individuals with endometriosis experience symptoms, but common ones include pelvic pain, painful periods, discomfort during sexual intercourse, and challenges with conception. Approximately 10% of women of reproductive age are affected, though the true prevalence is difficult to determine as diagnosis often requires laparoscopic surgery to confirm the presence of lesions. Endometriosis is a complex and widespread condition affecting women worldwide, regardless of ethnicity or social status. It is believed to result from multiple factors, including retrograde menstruation and cellular metaplasia, where cells outside the uterus transform into endometrial-like tissue. The condition is also heavily influenced by estrogen, which promotes inflammation, growth, and pain associated with the disease. Diagnosing endometriosis typically involves assessing a patient's menstrual and pelvic pain history. Although various diagnostic tools have been proposed, none are fully validated to identify individuals with certainty. Symptoms can mimic other conditions, leading to diagnostic delays. Imaging techniques like ultrasonography or MRI may be used to detect ovarian endometriomas, adhesions, or deep nodular lesions. Histologic confirmation, often following laparoscopic visualization, helps confirm the diagnosis but should not delay the initiation of empirical medical treatment. Treatment options range from conservative approaches, such as non-steroidal anti-inflammatory drugs (e.g., ibuprofen) to manage pain, to hormone-based medications that help control symptoms. Surgical intervention can both diagnose and treat endometriosis, with procedures to remove or destroy lesions and scar tissue, potentially alleviating pain and restoring normal pelvic anatomy. Find out more about endometriosis treatment drugs @ Drugs for Endometriosis Treatment A snapshot of the Endometriosis Pipeline Drugs mentioned in the report: Learn more about the emerging endometriosis pipeline therapies @ Endometriosis Clinical Trials Endometriosis Therapeutics Assessment The endometriosis pipeline report proffers an integral view of the endometriosis emerging novel therapies segmented by stage, product type, molecule type, mechanism of action, and route of administration. Scope of the Endometriosis Pipeline Report Coverage: Global Therapeutic Assessment By Product Type: Mono, Combination, Mono/Combination Therapeutic Assessment By Clinical Stages: Discovery, Pre-clinical, Phase I, Phase II, Phase III Therapeutics Assessment By Route of Administration: Oral, Intravenous, Subcutaneous, Parenteral, Topical Therapeutics Assessment By Molecule Type: Monoclonal antibody, Peptides, Polymer, Small molecule, Gene therapy Therapeutics Assessment By Mechanism of Action: LHRH receptor antagonists, Estrogen receptor agonists, Hormone replacements, Mineralocorticoid receptor antagonists, Progesterone receptor agonists, Testosterone congener inhibitors, Prostaglandin-E synthase inhibitors, Gonadotropin-releasing hormone inhibitors, Dopamine D2 receptor agonists, Prolactin receptor antagonists, Key Endometriosis Companies: Kissei Pharmaceutical, Mithra Pharmaceuticals, Gesynta Pharma, Jiangsu Hengrui Medicine Co., Ferring Pharmaceuticals, Hope Medicine (Nanjing) Co., Ltd, VaRi Bioscience, SWK Holdings, Ananda Developments, TiumBio, Ironwood Pharmaceuticals, Chugai Pharmaceutical, Viramal, Organon, Mitsubishi Tanabe Pharma, Antev, Foraviset, ValiRx, EpicentRx, Temple Therapeutics, Celmatix, BCI Pharma, Gynica, PrecisionLife, Flightpath Biosciences, and others. Key Endometriosis Pipeline Therapies: Linzagolix, Estelle, Vipoglanstat, SHR7280, Quinagolide, HMI-115, VR103, Ovarest, MRX1, TU2670, IW-3300, AMY-109, VML 0501, OG-6219, Teverelix trifluoroacetate, Raviset, VAL301, Nibrozetone, TTX334e, IntraVagS302, IntraVagS301, FP-300 and others. Dive deep into rich insights for new drugs for endometriosis treatment, visit @ Endometriosis Drugs Table of Contents For further information on the endometriosis pipeline therapeutics, reach out @ Endometriosis Treatment Drugs Related Reports Endometriosis Market Endometriosis Market Insights, Epidemiology, and Market Forecast – 2034 report deliver an in-depth understanding of the disease, historical and forecasted epidemiology, market share of the individual therapies, and key endometriosis companies including AbbVie, Neurocrine Biosciences, ObsEva, Kissei Pharmaceuticals, SWK, Enteris BioPharma, Bayer, Hope Medicine, Tiumbio, Organon, among others. Endometriosis Epidemiology Forecast Endometriosis Epidemiology Forecast – 2034 report delivers an in-depth understanding of the disease, historical and forecasted endometriosis epidemiology in the 7MM, i.e., the United States, EU5 (Germany, Spain, Italy, France, and the United Kingdom), and Japan. Endometriosis Pain Market Endometriosis Pain Market Insights, Epidemiology, and Market Forecast – 2034 report delivers an in-depth understanding of the disease, historical and forecasted epidemiology, as well as the market trends, market drivers, market barriers, and key endometriosis pain companies, including Ferring Pharmaceuticals, ObsEva SA, Myovant Sciences, Hope Medicine (Nanjing) Co., Ltd, among others. Endometriosis Pain Pipeline Endometriosis Pain Pipeline Insight – 2025 report provides comprehensive insights about the pipeline landscape, pipeline drug profiles, including clinical and non-clinical stage products, and the key endometriosis pain companies, including Ferring Pharmaceuticals, ObsEva SA, Myovant Sciences, Hope Medicine (Nanjing) Co., Ltd, among others. About DelveInsight DelveInsight is a leading Business Consultant and Market Research firm focused exclusively on life sciences. It supports pharma companies by providing comprehensive end-to-end solutions to improve their performance. Get hassle-free access to all the healthcare and pharma market research reports through our subscription-based platform PharmDelve . Contact Us Shruti Thakur [email protected] +14699457679 Logo: SOURCE DelveInsight Business Research, LLP WANT YOUR COMPANY'S NEWS FEATURED ON PRNEWSWIRE.COM? 440k+ Newsrooms & Influencers 9k+ Digital Media Outlets 270k+ Journalists Opted In GET STARTED

Uppsala, Sweden – January 20, 2025 – Orexo AB (publ.), (STO:ORX) (OTCQX:ORXOY), today announces that rights to future transaction proceeds and royalty on future net revenues for the drug candidate vipoglanstat (OX-MPI), have been converted to shares in Gesynta Pharma AB (“Gesynta”). The transaction took place in connection with Gesynta's recent capital raise and Orexo’s shares are valued at SEK 19.2 million. The value generated will be recognized under other operating income in Orexo’s Q4, 2024 results. In 2017, Orexo and Gesynta entered into a purchase agreement under which Gesynta acquired all assets related to OX-MPI, with the intention of developing the drug candidate. In return, Orexo was entitled to receive share of future transaction proceeds and royalty on future net revenues generated from the program. With successful fundraising, Gesynta will now proceed with development of vipoglanstat in a phase II clinical trial. The drug candidate has the potential to revolutionize the treatment of the inflammatory disease endometriosis, which affects 190 million women worldwide. Nikolaj Sørensen, CEO and President of Orexo AB said: “We are pleased to see the support from investors to Gesynta and the continued development of vipoglanstat. The early data from vipoglanstat is impressive and the drug candidate has the potential to help millions of women worldwide living with the chronic disease endometriosis. Orexo looks forward to continue as a shareholder in Gesynta and this transaction is fully in line with our objective of strengthening the Orexo financial results and equity position.” For further information contact: Orexo AB (publ.) Nikolaj Sørensen, President and CEOLena Wange, IR & Communications DirectorTel: +46 18 780 88 00E-mail: ir@orexo.com About Orexo Orexo is a Swedish pharmaceutical company with 30 years of experience developing improved pharmaceuticals based on proprietary formulation technologies that meet large medical needs. On the US market, Orexo provides innovative treatment solutions for patients suffering from opioid use disorder and adjacent diseases. Products targeting other therapeutic areas are developed and commercialized worldwide with leading partners. Total net sales in 2023 amounted to SEK 639 million, and the number of employees to 116. Orexo is listed on Nasdaq Stockholm's main list and is available as an ADR on OTCQX (ORXOY) in the US. For more information about Orexo please visit www.orexo.com. You can also follow Orexo on X, LinkedIn, and YouTube. About Gexynta Pharma Gesynta Pharma is a clinical-stage pharmaceutical company developing innovative treatments by targeting mPGES-1, a key enzyme in inflammatory processes. Gesynta Pharma's research originated at Karolinska Institutet in Sweden. The lead compound, vipoglanstat, is being developed for the treatment of endometriosis – a painful chronic inflammatory disease that affects about 10 percent of women of reproductive age. Endometriosis often leads to a severely reduced quality of life and current drug treatments are inadequate for many patients, partly due to troublesome side effects. Vipoglanstat is a non-hormonal, non-opioid, disease-modifying drug candidate that selectively inhibits mPGES-1; it has demonstrated a favorable safety profile and potent inhibition of mPGES-1 in Phase I and II clinical trials. A preclinical proof-of-concept study in an advanced disease model of endometriosis shows that vipoglanstat significantly reduces endometrial lesions and positively impacts pain-related parameters and well-being. A Phase II clinical trial in patients with endometriosis is expected to start in 2025. A second drug candidate in the Gesynta Pharma portfolio, GS-073, is ready to enter clinical Phase I for the treatment of chronic inflammatory pain. The company's shareholders include Hadean Ventures, Industrifonden, Innovestor Life Science, and other internationally renowned specialist investors. For more information, please visit www.gesynta.se. The information was submitted for publication, through the agency of the contact persons set out above, at 8.45 CEST on January 20, 2025.

Khondrion receives FDA clearance of IND application for pivotal Phase 3 clinical trial of sonlicromanol for the treatment of primary mitochondrial disease 52-week Phase 3 trial to investigate potential of novel, brain-penetrant redox-modulator with anti-inflammatory properties, in adult patients with most common genetic defect causing primary mitochondrial disease, m.3243A>GPrimary endpoints focused on most burdensome and frequently occurring effects of disease – chronic fatigue and muscle weakness – supported by significant and clinically relevant patient benefits achieved by sonlicromanol in its integrated Phase 2b program NIJMEGEN, the Netherlands – 14 November 2024: Khondrion, a clinical stage biopharmaceutical company discovering and developing therapies targeting primary mitochondrial disease (PMD), today announced that it has received clearance from the U.S. Food and Drug Administration (FDA) for its Investigational New Drug (IND) application for sonlicromanol. The IND supports the initiation of a pivotal Phase 3 trial in adult patients with PMD due to the m.3243A>G mutation, the most common genetic defect causing PMD. The company expects to initiate the trial in 2025. Sonlicromanol, Khondrion’s lead proprietary drug candidate, is a potentially disease-modifying first-in-class, brain-penetrant redox-modulator with anti-inflammatory properties, that targets key metabolic and inflammatory pathways underlying PMD. The Company’s multicenter Phase 2b program, recently published in the scientific journal Brain, highlighted strong patient benefits from sonlicromanol in multiple outcome measures. That program’s 52-week extension study, which continued to treat some patients out to 78 weeks, demonstrated durable improvements among patients receiving sonlicromanol in several relevant domains, including chronic fatigue and muscle weakness, two of the most burdensome symptoms of PMD as described by patients. The drug candidate’s potential to treat these aspects of disease will be further investigated in the upcoming Phase 3 trial. The 52-week double-blind, randomized, placebo-controlled, multi-center, parallel-group Phase 3 trial is expected to enroll 150 adult patients with a genetically confirmed mitochondrial DNA tRNALeu(UUR) m.3243A>G variant. For this study, Khondrion has selected the Neuro-QoL Fatigue short form questionnaire and the Five Times Sit-to-Stand test as its two independent primary endpoints. These outcome measures, assessing patients’ most burdensome and frequent effects of disease (chronic fatigue and muscle weakness), have encouragingly shown clinically meaningful and statistically significant (p-value of 0.004 and 0.0161, respectively) results in the 52-week open-label extension part of the Phase 2b program. Further details of the Phase 3 trial’s design can be found on ClinicalTrials.gov here. Prof. Dr. Jan Smeitink, Chief Executive Officer at Khondrion, said: “The FDA’s clearance of our IND application for a pivotal Phase 3 trial marks another important milestone for Khondrion’s development of sonlicromanol, a disease-modifying therapy for primary mitochondrial disease that is so desperately needed by PMD patients. We look forward to sharing progress of our clinical program including its expected initiation next year.” Sonlicromanol: one of the most advanced drug candidates in development for PMDSonlicromanol has been investigated in four clinical trials, three in adult PMD patients with m.3243A>G, as well as in the first wave of a six-month Phase 2 study in children with genetically confirmed PMD suffering from motor symptoms. Encouragingly, seven patients in the Netherlands, who elected to participate in a named patient program following completion of the Phase 2b open label extension study out to 78 weeks, have been receiving sonlicromanol for more than two and a half years, thus confirming the drug’s favorable safety profile. Khondrion is initially focusing the development of sonlicromanol on PMD patients with the m.3243A>G variant, which is the most common genetic defect causing multi-systemic PMD and has an estimated prevalence of 4.4:100,000. There are currently no approved therapies for PMD associated with the m.3243A>G variant. The Company’s longer-term objective is to make sonlicromanol widely available for the broader PMD patient community. PMDs are the most prevalent inherited neurometabolic disorders, estimated to affect at least 1 in 4,300 which translates into approximately 65,000 people in the US alone. Khondrion’s wholly-owned, proprietary drug candidate has received orphan drug designation in the US and Europe and has also been granted a rare pediatric disease designation. – ENDS – Notes to editors About KhondrionKhondrion is a clinical stage biopharmaceutical company developing therapies for patients with primary mitochondrial disease (PMD). The company’s lead asset, sonlicromanol, is a potentially first-in-class, brain-penetrant redox-modulator with anti-inflammatory properties, that targets key metabolic and inflammatory pathways underlying PMD. One of the most advanced, disease-modifying drug candidates for mitochondrial disease in development, sonlicromanol has been tested in three clinical trials in patients with m.3243A>G PMD, as well as in the first wave of a 6-month Phase 2 study in children with genetically confirmed PMD and who suffer from motor symptoms. Sonlicromanol has been granted orphan drug designations for the treatment of MELAS syndrome (mitochondrial encephalopathy, lactic acidosis, and stroke-like episodes), Leigh disease and patients with maternally inherited diabetes and deafness (MIDD) in Europe, and for all inherited mitochondrial respiratory chain disorders in the U.S. It has also been granted a rare pediatric disease designation in the US for the treatment of MELAS. Sonlicromanol and other compounds from Khondrion’s proprietary library have the potential to be developed for a wide range of diseases and conditions with the aim of benefiting patients whose daily lives are severely impacted by mitochondrial impairment. For more information visit www.khondrion.com. About Primary Mitochondrial DiseaseMitochondrial disease occurs when mitochondria, found within all cells of the human body except erythrocytes, and responsible for producing the energy necessary for cells to function, are defective. This can result in a wide range of serious and debilitating illnesses occurring shortly after birth or later in life. Signs and symptoms of these can include cognitive problems, learning disabilities, blindness, deafness, heart failure, diabetes, fatigue, intolerance to exercise, muscle weakness and gait problems, and stunted growth. Originally referred to as MELAS syndrome (mitochondrial encephalopathy, lactic acidosis, and stroke-like episodes), primary mitochondrial disease associated with the m.3243A>G variant in the mitochondrial genome is now considered to include a spectrum of phenotypes including classic MELAS, MIDD syndrome (maternally inherited diabetes mellitus and deafness), MP (mixed phenotypes) and CPEO (chronic progressive external ophthalmoplegia). Learn more. Forward-looking statementsThis press release may contain certain forward-looking statements regarding, among other things, the results, conduct, progress and timing of the company’s clinical trials and presentation of data from clinical trials for sonlicromanol. Although the company believes its expectations are based on reasonable assumptions, 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,” “goal,” “intend,” “may,” “anticipate,” “foreseen,” “estimate,” “plan,” “project,” “will,” “can have,” “likely,” “potential,” “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, performance or achievements to be materially different from the expected results, performance or achievements expressed or implied by such forward-looking statements. Except as required by law, the company assumes no obligation to update these forward-looking statements publicly, or to update the reasons actual results could differ materially from those anticipated in the forward-looking statements, even if new information becomes available in the future. Contacts: Khondrion BVProf. Dr. Jan Smeitink, CEOE-mail: info@khondrion.comTel: +31-24-7635000www.khondrion.com ICR Healthcare David Daley, Kris LamEmail: khondrion@icrhealthcare.com 1 Excluding data from two subjects whose baseline duration in the 5xSST test was below the envisaged threshold criteria to be used for analysis of the 5xSST test endpoint in the Phase 3 trial