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InMed Pharmaceuticals (INM) Earnings Call Presentation
2025-07-04 07:54
Alzheimer's Disease Burden and Current Treatments - Alzheimer's accounts for 60-80% of dementia cases[6] - It affects 6.9 million Americans[6] - Alzheimer's is the 5th leading cause of death for those aged 65+[6] - The U.S annual financial impact of Alzheimer's and other dementias is $360 billion[6] - Current treatments primarily target amyloid-beta plaques but have limitations, including limited therapeutic effects and side effects[14, 15] INM-901: A Multifactorial Approach - INM-901 is an orally available small molecule drug candidate that can cross the blood-brain barrier[8, 21, 48] - It acts as a preferential signaling agonist for CB1/CB2 receptors and impacts the PPAR signaling pathway[8, 18, 21] - In vitro studies show INM-901 demonstrates neuroprotective effects and increased neurite outgrowth, signifying enhanced neuronal function[8, 27, 28, 29, 32] - Preclinical in vivo studies suggest INM-901 improves behavior and cognitive function, reduces neuroinflammation, and enhances neuronal function[8, 39, 42, 44] - Molecular data indicates INM-901 reduces pro-inflammatory genes and elevates neuronal function genes[42]
Fresenius Medical Care Collaborates with Coordination of National Institutes of Health and Specialty Hospital to Extend Access to Innovative Dialysis Therapy in Mexico
Prnewswire· 2025-07-03 12:00
High-Volume Hemodiafiltration is used for the first time in seven out of 10 CCINSHAE centers in Mexico In Mexico, 240 CCINSHAE patients are now being treated; more than 410 regular patients also treated Fresenius Medical Care is committed to expanding HighVolumeHDF therapy to all markets where it is not already present, including the United StatesBAD HOMBURG, Germany, July 3, 2025 /PRNewswire/ -- Fresenius Medical Care (FME), the world's leading provider of products and services for individuals with renal ...
NewAmsterdam Pharma Company (NAMS) Earnings Call Presentation
2025-07-03 10:51
Clinical Program and Trial Results - NewAmsterdam Pharma completed enrollment for BROOKLYN, BROADWAY and PREVAIL Phase 3 studies[5] - The BROOKLYN Phase 3 trial, involving 354 participants with HeFH and LDL-C ≥70 mg/dL, has primary endpoint of LDL-C reduction at 12 weeks[46, 49] - The BROADWAY Phase 3 trial, involving 2,532 participants with ASCVD or HeFH and LDL-C ≥55 mg/dL, also has primary endpoint of LDL-C reduction at 12 weeks[46, 53] - The PREVAIL CVOT, involving 9,541 participants with ASCVD and LDL-C ≥55 mg/dL, has primary endpoint of 4-Point MACE+ with a minimum 30-month follow-up[46, 61] - Initial data from an Alzheimer's Disease sub-study showed that obicetrapib 10mg decreased 24s- & 27s-hydroxycholesterol in both plasma and cerebrospinal fluid in a phase 2a study (n=13)[55] Obicetrapib's Potential Benefits - Obicetrapib observed to lower small LDL-P by 90%+ and total particles by over 70% in combination with ezetimibe[24] - Obicetrapib 10 mg on top of high-intensity statins significantly lowered Lp(a) by 57% vs placebo, in ROSE[80] - Obicetrapib monotherapy observed a 43% mean LDL-C lowering[30] - Obicetrapib in combination with ezetimibe observed a 59% mean LDL-C lowering on top of high-intensity statins[31] Commercial Opportunity - Approximately 30 million+ patients in the US are not achieving LDL-C lowering goals despite standard-of-care[30] - The lipid-lowering therapy market has over 250 million prescriptions annually[164] - The market is growing at over 4% over the last 2 years, with the non-statin market growing at high double digits[164] Financial Position - NewAmsterdam Pharma had $481 million in cash as of 1Q24[225]
HUTCHMED to Announce 2025 Half-Year Financial Results
Globenewswire· 2025-07-03 08:30
Core Points - HUTCHMED will announce its interim results for the six months ended June 30, 2025, on August 7, 2025, at 7:00 am EDT [1] - The company will host two webcast presentations for analysts and investors to discuss the interim results, with the English session at 8:00 am EDT and the Chinese session at 8:30 am HKT on August 8, 2025 [2] - Both webcasts will be available live on the company website, with a replay accessible shortly after the events [3] Company Overview - HUTCHMED is an innovative, commercial-stage biopharmaceutical company focused on the discovery, global development, and commercialization of targeted therapies and immunotherapies for cancer and immunological diseases [4] - The company has successfully marketed its first three medicines in China, with the first also approved globally, including in the US, Europe, and Japan [4]
Eton Pharmaceuticals (ETON) Earnings Call Presentation
2025-07-03 06:58
This document contains forward-looking statements concerning Eton Pharmaceuticals, Inc. ("Eton", the "Company," "we," "us," and "our"). The words "believe," "may," "will," "potentially," "estimate," "continue," "anticipate," "intend," "could," "would," "project," "plan," "expect" and similar expressions that convey uncertainty of future events or outcomes are intended to identify forward-looking statements. These forward-looking statements include, but are not limited to, statements concerning the following ...
X @The Economist
The Economist· 2025-07-03 05:45
They could treat diseases, test drugs and boost crop yields https://t.co/4W4J9iQsWq ...
Outlook Therapeutics Appoints Biopharmaceutical Industry and Commercial Leader Bob Jahr as Chief Executive Officer
Globenewswire· 2025-07-01 12:05
Company Overview - Outlook Therapeutics, Inc. is a biopharmaceutical company focused on enhancing the standard of care for bevacizumab in the treatment of retina diseases [9] - The company has launched LYTENAVA™ (bevacizumab-vikg; bevacizumab gamma) in Europe, specifically in Germany and the UK, for the treatment of wet age-related macular degeneration (AMD) [9] Leadership Appointment - Bob Jahr has been appointed as the Chief Executive Officer (CEO) of Outlook Therapeutics and will also join the Board of Directors [1][2] - Lawrence A. Kenyon will continue in his role as Chief Financial Officer (CFO) and remain a member of the Board of Directors [1] Executive Experience - Mr. Jahr brings over 20 years of experience in the biopharmaceutical industry, having led commercial teams across various therapeutic areas including rare disease, oncology, and hematology [3] - He has a proven track record of managing multiple billion-dollar assets and franchises [3] Strategic Importance - The appointment of Mr. Jahr is seen as timely due to the ongoing commercial launch in Europe and the potential for U.S. FDA approval in the coming months [2] - Mr. Jahr expressed excitement about joining the company at a pivotal time, emphasizing the potential of LYTENAVA™ to transform the global retina market [4] Inducement Grant - The Board of Directors approved an option for Mr. Jahr to purchase 800,000 shares of common stock as an inducement for his employment [6] - The option will be issued on July 1, 2025, with an exercise price equivalent to the closing price of the stock on that date, vesting over four years [7]
Apellis to Receive up to $300 Million from Royalty Purchase Agreement with Sobi for Ex-U.S. Royalties of Aspaveli® (systemic pegcetacoplan)
GlobeNewswire News Room· 2025-07-01 11:00
Core Viewpoint - Apellis Pharmaceuticals has entered into a capped royalty purchase agreement with Sobi, allowing Apellis to receive up to $300 million in exchange for 90% of its future ex-U.S. royalties for Aspaveli, which is a treatment for rare diseases [1][2][3] Transaction Details - Apellis will receive $275 million upfront and may earn up to $25 million in milestone payments upon EMA approval for Aspaveli in treating C3G and IC-MPGN [3][7] - The agreement includes defined caps tied to Aspaveli's performance, after which 100% of ex-U.S. royalties will revert to Apellis [4] Product Information - Aspaveli (systemic pegcetacoplan) is approved in the EU and the U.S. for treating paroxysmal nocturnal hemoglobinuria (PNH) and is under review for C3 glomerulopathy (C3G) and primary immune complex membranoproliferative glomerulonephritis (IC-MPGN) [2][5] - Approximately 50% of patients with C3G and IC-MPGN may experience kidney failure within five to ten years of diagnosis, highlighting the urgency for effective treatments [6] Strategic Implications - The transaction is seen as a non-dilutive funding method that strengthens Apellis' balance sheet and provides operational flexibility as the company approaches sustainable profitability [2][7] - Sobi's expertise in rare diseases and its commercial footprint are expected to enhance the reach of Aspaveli globally following regulatory approvals [3]
Crinetics to Showcase the Next Generation of Endocrinology Innovation at ENDO 2025 with Eight Presentations From its Deep Pipeline
Globenewswire· 2025-06-30 20:05
Core Insights - Crinetics Pharmaceuticals is set to present long-term efficacy and safety data for its investigational drug PALSONIFY (paltusotine) in acromegaly, demonstrating both biochemical and symptom control with a well-tolerated safety profile [1][2] - The company will also showcase Phase 2 trial results for atumelnant in congenital adrenal hyperplasia (CAH) and data from early-stage development programs in Graves' hyperthyroidism and orbitopathy at the Endocrine Society's Annual Meeting, ENDO 2025 [1][3] PALSONIFY Presentations - Four abstracts will report results from the PALSONIFY development program, including an oral presentation on long-term efficacy, safety, and symptom control in acromegaly patients switching from injectable somatostatin receptor ligands to once-daily oral PALSONIFY [2][4] - Three poster presentations will cover symptom stability in acromegaly, patient-reported outcomes from PATHFNDR-1 and PATHFNDR-2, and open-label extension data from PATHFNDR-2 [2] Atumelnant Presentations - Three abstracts will focus on atumelnant, including an oral presentation of Phase 2 trial results in CAH, highlighting reductions in adrenal volume and significant decreases in potent 11-oxygenated androgens [3][7] Early-Stage Pipeline - Crinetics will present new data from its early-stage pipeline, including findings related to CRN12755 for Graves' hyperthyroidism and orbitopathy [4][8] Company Overview - Crinetics Pharmaceuticals is a clinical-stage pharmaceutical company focused on developing novel therapeutics for endocrine diseases and related tumors, with PALSONIFY and atumelnant as its lead candidates [11]
Alzheimer's Setback Hits INmune Bio Stock, But FDA Hopes Remain
Benzinga· 2025-06-30 15:52
INmune Bio Inc. INMB stock is trading lower on Monday, with a session volume of 23.2 million, compared to the average volume of 1.45 million, as per data from Benzinga Pro. The company announced results from its Phase 2 MINDFuL trial evaluating XPro, a selective soluble TNF inhibitor, in early Alzheimer's Disease with biomarkers of inflammation. Also Read: Europe Approves Eisai-Biogen's Alzheimer's Drug 'Under Strict Conditions' After Initial Negative Opinion Despite showing no effects in the modified inten ...