First Clinic Targeted to Open Q4, 2025 in the U.S. VANCOUVER, British Columbia, May 13, 2025 (GLOBE NEWSWIRE) -- Algernon Pharmaceuticals Inc. (the "Company" or "Algernon") (CSE: AGN) (FRANKFURT: AGW0) (OTCQB: AGNPF), a Canadian healthcare and clinical stage drug development company, is pleased to announce it has entered into share exchange agreements to acquire 100% of the issued and outstanding shares of NoBrainer Imaging Centers, Inc. ("NIC") (the "Transaction"). The Transaction moves Algernon into the A ...

Summary of AN2 Therapeutics (ANTX) Conference Call Company Overview - **Company**: AN2 Therapeutics (ANTX) - **Focus**: Development of novel therapeutics for infectious diseases and oncology Key Points Novel Drug Development - AN2 Therapeutics is developing two novel compounds targeting previously unaddressed areas in human medicine: one antibacterial and one antiparasitic [1] - The company is leveraging boron chemistry to expedite drug development, which has favorable pharmacokinetic properties and operates in a less crowded intellectual property space [1][2] Chagas Disease Treatment - The oral candidate AN2502998 is in phase one trials, targeting Chagas disease, which affects approximately seven million people globally, with significant cardiac complications in about 30% of patients [6][8] - The drug is expected to provide a cure for chronic Chagas disease, with a potential market opportunity estimated at over one billion dollars [15] - The company plans to implement a "test and treat" strategy to increase awareness and diagnosis of Chagas disease in the U.S. [17] Regulatory Path and Clinical Trials - AN2 Therapeutics anticipates a streamlined regulatory path due to the high unmet need for Chagas disease treatment, planning a Phase II and pivotal Phase III trial [19][21] - The company has a contract with the NIH for $18 million to support a phase two proof of concept study for melioidosis, a serious infectious disease with high mortality rates [25][26] Oncology Programs - AN2 is entering the oncology space with two targets utilizing boron chemistry, focusing on ENPP1, which is involved in cancer metastasis, and PI3 kinase alpha, which has significant competition [40][41] - The company believes it can develop best-in-class compounds with unique binding properties and a strong intellectual property position [46][48] Market Potential and Competitive Landscape - The market for abscessus, a type of NTM infection, is estimated to be a multibillion-dollar opportunity, with a significant patient population in the U.S. and Japan [34] - AN2 aims to differentiate its oncology drugs through unique chemistry and a strong IP position, avoiding crowded spaces with overlapping structures [47][48] Financial Position - The company has sufficient cash reserves to fund operations and development through 2028, allowing for multiple avenues of growth despite recent setbacks in NTM drug development [48] Additional Insights - The company emphasizes the importance of addressing neglected tropical diseases and the potential for significant patient impact alongside commercial opportunities [9][29] - AN2 is committed to advancing its drug candidates quickly, with plans for rapid clinical trials and a focus on patient outcomes [14][20][37]

Core Viewpoint - Biogen reported first-quarter 2025 adjusted earnings per share (EPS) of $3.02, missing the Zacks Consensus Estimate of $3.32, with an 18% year-over-year decline in earnings due to a $165 million upfront payment to Stoke Therapeutics for a collaboration agreement [1][2][19] Financial Performance - Total revenues for Q1 2025 were $2.43 billion, reflecting a 6% year-over-year increase on a reported basis and an 8% increase on a constant-currency basis, surpassing the Zacks Consensus Estimate of $2.23 billion [2] - Total product sales reached $1.73 billion, up 1% year over year on a reported basis and 3% on a constant-currency basis [4] - Contract manufacturing and royalty revenues surged 61% year over year to $293 million, while Alzheimer's collaboration revenues increased to $33 million from $3 million in the prior year [5][6] Product Sales Breakdown - Multiple sclerosis (MS) revenues totaled $953 million, down 11% on a reported basis due to generic competition for Tecfidera [9] - Sales of Spinraza rose 24.2% to $423.9 million, exceeding the Zacks Consensus Estimate of $365 million [12] - New drug Qalsody for ALS recorded sales of $15.5 million, while Zurzuvae for postpartum depression generated $28 million in sales, reflecting a 21.7% sequential increase [13][14] Cost and Guidance - Adjusted R&D expenses decreased 3% year over year to $427 million, while adjusted SG&A expenses rose 1% to $572 million [16] - The company reaffirmed its total revenue guidance for 2025, expecting a mid-single-digit percentage decline in constant currency terms compared to 2024, and lowered its adjusted EPS guidance to a range of $14.50 to $15.50 [18][19] Market Performance - Year to date, Biogen's shares have declined 20.9%, compared to a 3.3% decrease in the industry [3]

Investment Rating - The report provides a short-term investment focus on specific companies across various sectors, highlighting preferred and risk names based on tariff impacts [7][30]. Core Insights - The report analyzes the implications of the Trump administration's tariffs on nine major sectors, emphasizing the direct and indirect impacts on individual companies and their stock performance [6][30]. - The automotive sector is expected to face significant price increases due to tariffs, with an estimated 11.5% rise in US auto prices, translating to approximately $5,100 per vehicle [9][17]. - The report identifies key companies within each sector that are likely to be affected by tariffs, providing a detailed analysis of their potential performance [4][30]. Sector Summaries Autos and Auto Parts - Tariffs on automobiles could lead to a gross impact on operating profit ranging from 30% to over 100% for various automakers, with Toyota and Honda facing a manageable impact while Nissan and Mazda are at higher risk [4][9]. - Focus is placed on Toyota Motor for its resilience and ability to raise prices, while Bridgestone is noted for its high local production ratio [30][31]. Banks - The impact of tariffs on banks remains uncertain, but concerns over worst-case scenarios have eased, with a potential downside risk of slightly over 10% to sector earnings forecasts in a bearish scenario [4][33]. - Japan Post Bank is highlighted as a relatively stable option amidst tariff uncertainties [4][33]. Pharmaceuticals and Medical Devices - Major pharmaceutical companies like Takeda and Astellas are expected to be heavily impacted by tariffs, while companies with lower US sales ratios may benefit from tariff avoidance [4][30]. - The report emphasizes the potential for increased costs of goods sold (CoGS) affecting operating profits for medical device companies [4]. Technology - The technology sector's tariff impact is complex, with companies like NEC and Fujitsu expected to perform well due to limited exposure to tariffs [5][30]. - Sony Group is under close observation for potential price hikes on its products, particularly the PlayStation 5 [5][30]. Chemicals and Steel - In the chemicals sector, companies like Nippon Paint are expected to benefit from lower raw material prices, while the steel sector is anticipated to experience limited direct tariff impacts [5][30]. - Kobe Steel is noted for its resilience due to a significant earnings contribution from its machinery business [5][30]. Retail - The retail sector is advised to focus on drugstores and discount retailers, with companies like Asics and Fast Retailing facing risks from declining sales due to high tariff exposure [5][30]. - Seven & i Holdings is highlighted as particularly vulnerable due to its significant exposure to the US market [5][30].

Core Insights - Merck reported Q1 2025 adjusted EPS of $2.22, exceeding the Zacks Consensus Estimate of $2.15, with a year-over-year earnings increase of 7% on a reported basis and 12% excluding foreign exchange impacts [1][2] - Revenues declined 2% year-over-year to $15.53 billion, but still surpassed the Zacks Consensus Estimate of $15.39 billion [2] Sales Performance - Keytruda, Merck's flagship product, generated sales of $7.21 billion, a 6% increase, but missed the Zacks Consensus Estimate of $7.55 billion due to timing issues in wholesaler purchases [3] - Alliance revenues from Lynparza and Lenvima contributed positively, with Lynparza sales increasing 8% to $312 million and Lenvima revenues totaling $258 million, up 2% [4] - Welireg sales surged 63% to $137 million, driven by higher demand in the U.S. [5] Vaccine Sales - Sales of HPV vaccines Gardasil and Gardasil 9 fell 40% to $1.33 billion, primarily due to lower demand in China [6] - Combined sales of Proquad, M-M-R II, and Varivax vaccines decreased 5% to $539 million, while sales of the pneumococcal 15-valent conjugate vaccine Vaxneuvance rose 7% to $230 million [7][8] Diabetes and Other Products - Sales of the Januvia/Janumet franchise rose 21% year-over-year to $796 million, benefiting from higher net pricing in the U.S. [9] - New PAH drug Winrevair generated $280 million in sales, up from $200 million in the previous quarter [9] Animal Health Segment - The Animal Health segment generated revenues of $1.59 billion, up 5% year-over-year, driven by higher demand for livestock products [11] Cost and Margin Analysis - Adjusted gross margin was 82.2%, up 100 basis points year-over-year, while adjusted selling, general and administrative expenses rose 3% to $2.53 billion [12] - Adjusted R&D spending decreased 9% to $3.61 billion, attributed to lower business development charges [13] 2025 Guidance - Merck maintained its sales guidance for 2025, expecting revenues between $64.1 billion and $65.6 billion, with a revised negative impact from foreign exchange of around 1% [14] - Adjusted EPS guidance was revised to a range of $8.82 to $8.97, accounting for a one-time charge related to a licensing agreement [16] Market Reaction and Future Outlook - Shares of Merck traded higher in pre-market following the earnings report, despite a 21% year-to-date decline compared to a 3% fall in the industry [19] - The company is aware of its reliance on Keytruda and is taking steps to diversify its portfolio, with a late-stage pipeline that has nearly tripled over the past three years [21]

Core Viewpoint - Biogen is expected to report first-quarter 2025 results on May 1, with sales and earnings estimates at $2.24 billion and $3.34 per share, respectively. The company faces challenges from declining sales of multiple sclerosis (MS) drugs, which may be offset by revenues from new drugs [1][2][5]. Sales Performance of MS Drugs - Sales of Biogen's MS drugs, including Tecfidera and Tysabri, are anticipated to decline due to increased competition and the introduction of generic versions in various markets [2][5]. - The Zacks Consensus Estimate for Tecfidera sales is $199.0 million, while the internal estimate is $185.7 million. For Tysabri, the estimates are $363.0 million and $348.6 million, respectively [3][4]. - Vumerity's sales rose in the fourth quarter due to higher demand, with estimates for the first quarter at $141.0 million (Zacks) and $139.8 million (internal) [4]. Impact of Biosimilars and Generics - The decline in MS revenues is expected to be more pronounced in 2025 due to the anticipated entry of biosimilars for Tysabri and generics for Tecfidera in certain European markets [5]. Other Drug Sales - Spinraza's sales improved in the fourth quarter, but demand may have decreased in the first quarter, with estimates at $364.0 million (Zacks) and $338.1 million (internal) [6]. - Sales of Skyclarys for Friedreich's ataxia are expected to rise year-over-year, with estimates at $110.0 million (Zacks) and $111.4 million (internal) [7]. - Zurzuvae's launch has exceeded expectations, with strong patient demand likely contributing to improved sales in the first quarter [8][9]. Alzheimer's Collaboration and Revenues - Revenues from contract manufacturing, royalties, and Alzheimer's collaboration are expected to rise, particularly from the drug Leqembi, which has shown strong sales growth in recent quarters [10][11]. - Leqembi's sales have improved sequentially, with strong growth noted in China and Japan, and it was recently approved in the European Union [11][12]. Overall Revenue Expectations - Overall revenues for the first quarter of 2025 are expected to be negatively impacted by seasonality, higher discounts, and channel dynamics in the U.S., along with foreign exchange headwinds [13]. Key Events - Biogen announced a collaboration with Stoke Therapeutics to develop zorevunersen for Dravet syndrome, with a pivotal study expected to begin in the first quarter of 2025 [14]. Earnings Surprise History - Biogen has consistently beaten earnings estimates in the past four quarters, with an average earnings surprise of 11.8%. However, the current model does not predict a beat for the upcoming quarter, with an Earnings ESP of -15.8% [15][16][17].

Core Viewpoint - The European Commission has granted marketing authorization for Leqembi (lecanemab) to treat early Alzheimer's disease, marking a significant regulatory milestone for Biogen and Eisai [1][4][7]. Company Developments - Biogen's partner, Eisai, is responsible for the clinical development and regulatory submissions for Leqembi, although both companies co-commercialize the drug [2]. - Biogen's stock has decreased by 23.5% year-to-date, contrasting with a 6.5% decline in the industry [3]. Regulatory Approval Process - The approval for Leqembi followed a series of delays, including a negative opinion from the European Medicines Agency's Committee for Medicinal Products for Human Use (CHMP) in July 2024 [4][5]. - The CHMP initially raised concerns about the drug's safety, particularly regarding amyloid-related imaging abnormalities (ARIA) [6]. - After reassessing new safety data, the CHMP reaffirmed its positive opinion for Leqembi in February 2025 [9]. Market Performance - Leqembi has been approved in multiple countries, including the United States, China, Japan, and Great Britain [10]. - Sales of Leqembi showed a sequential improvement, with Eisai reporting nearly $87 million in global revenues in Q4 2024, reflecting a 30% increase [11]. Future Prospects - A less frequent maintenance intravenous dosing version of Leqembi was approved by the FDA in January 2025, with a subcutaneous autoinjector under review [12]. - Both companies believe Leqembi has the potential to achieve blockbuster sales due to the significant unmet medical need for Alzheimer's treatments [12]. Competitive Landscape - Leqembi and Eli Lilly's Kisunla are currently the only two FDA-approved drugs for early symptomatic Alzheimer's disease [13]. - Both drugs target the reduction of amyloid beta (Aβ) plaque in the brain, which is associated with cognitive decline in Alzheimer's patients [14].

Core Viewpoint - Biogen's investigational Alzheimer's disease drug, BIIB080, has received fast track designation from the FDA, which may expedite its development and review process [1][2]. Group 1: Fast Track Designation Benefits - Fast track designation aims to facilitate the development and expedite the review of drugs addressing serious conditions and unmet medical needs [2]. - The designation allows for rolling review, enabling Biogen to submit completed sections of its regulatory filing for BIIB080 as they become available, potentially speeding up the review process [2]. Group 2: BIIB080 Overview - BIIB080 is an investigational antisense oligonucleotide therapy targeting tau protein, which is linked to neurodegeneration and cognitive decline in Alzheimer's disease [5][6]. - The drug is currently being evaluated in the phase II CELIA study for early-stage Alzheimer's, with patient enrollment recently completed and data expected next year [5][6]. - Previous phase Ib study data indicated that BIIB080 treatment resulted in dose-dependent reductions in tau protein levels in cerebrospinal fluid and decreased tau buildup in the brain, along with positive trends in cognitive and functional measures [6]. Group 3: Partnership and Market Context - BIIB080 is developed in partnership with Ionis Pharmaceuticals, from which Biogen licensed exclusive global rights in December 2019, with Ionis eligible for royalties on potential sales [7]. - In the Alzheimer's drug market, two FDA-approved drugs, Leqembi and Kisunla, are currently available, both targeting amyloid beta plaque accumulation, a primary cause of cognitive decline [8][9].

Company Overview - Cassava Sciences (SAVA) recently faced a significant setback as its phase III study REFOCUS-ALZ for simufilam in mild-to-moderate Alzheimer's disease failed to meet the prespecified co-primary endpoints [1][4] - The study enrolled 1,125 Alzheimer's disease patients who received either simufilam or placebo for 76 weeks, but the drug did not show a significant reduction in cognitive and functional decline compared to placebo [2][3] Study Results - Treatment with simufilam did not achieve significant results on the ADAS-COG12 and ADCS-ADL scales over the 76-week period, nor did it meet any secondary or exploratory biomarker endpoints [2] - Despite the lack of efficacy, simufilam maintained an acceptable safety profile throughout the study [3][4] Program Termination - Following the failure of the REFOCUS-ALZ study, Cassava decided to discontinue the study and will phase out the development of simufilam for Alzheimer's disease by the end of the second quarter [4] - With the termination of this program, Cassava no longer has any late-stage candidates in its pipeline [4] Financial Position - As of December 2024, Cassava reported having $128.6 million in cash and equivalents, raising concerns about its ability to fund future operations [5] Industry Context - The Alzheimer's disease market is characterized by significant challenges in drug development, with many pharmaceutical and biotech companies experiencing setbacks [6] - Currently, there are two FDA-approved drugs for Alzheimer's disease: Leqembi and Kisunla, which target the reduction of amyloid beta plaques in the brain [7][8]

Core Viewpoint - Cassava Sciences' lead drug candidate simufilam has failed to meet primary endpoints in two late-stage studies for Alzheimer's disease, leading to a significant drop in the company's stock price by 32.1% [1][2]. Company Summary - The phase III REFOCUS-ALZ study, which involved 1,125 patients with mild-to-moderate Alzheimer's disease, did not show a significant reduction in cognitive and functional decline compared to placebo over 76 weeks [2][3]. - The study also failed to meet any pre-specified secondary and exploratory biomarker endpoints, and the drug demonstrated an acceptable safety profile [2][3]. - Following the disappointing results, Cassava has decided to discontinue the REFOCUS-ALZ study and the open-label extension study [6]. Future Steps - Cassava plans to phase out its Alzheimer's disease program by the end of Q2 2025 and has initiated preclinical studies to explore simufilam's potential for treating tuberous sclerosis complex-related epilepsy [7]. - The company is also reducing its workforce by 33% in Q1 2025 as part of cost management efforts, which will incur a one-time cost of approximately $0.4 million [8]. Industry Context - Currently, there are two FDA-approved drugs for Alzheimer's disease: Leqembi and Kisunla, both targeting early symptomatic stages of the disease [9]. - These drugs work by reducing the accumulation of amyloid beta plaque in the brain, which is associated with cognitive decline in Alzheimer's patients [10].