Celldex Therapeutics, Inc. (NASDAQ:CLDX) reported an EPS of -$1.22, missing estimates and indicating financial challenges. The company's revenue fell significantly short of expectations, with actual revenue at $121,000 versus an estimated $1.39 million. Despite financial hurdles, Celldex is advancing in clinical trials, with Phase 3 studies for chronic spontaneous urticaria fully enrolled and more studies underway. Celldex Therapeutics, Inc. (NASDAQ:CLDX) is a biotechnology company focused on developing tre ...

Prothena Fourth Quarter and Year-End 2025 Financial Results 4Q and FY25 Earnings Call Agenda | Welcome | Mark Johnson Vice President, Head of Investor Relations | | --- | --- | | Opening Remarks | Gene Kinney, Ph.D. President and CEO | | Clinical Programs | Chad Swanson, Ph.D. Chief Development Officer | | Preclinical Programs | Philip Dolan, Ph.D. Vice President, Head of Discovery Research | | Financial Results | Tran Nguyen Chief Strategy Officer and Chief Financial Officer | | Closing Remarks | Gene Kinn ...

Core Viewpoint - Immunic, Inc. has announced an oversubscribed private placement of up to USD 400 million to facilitate its transition into a commercial-stage company, focusing on the development of novel oral therapies for neurologic diseases, particularly multiple sclerosis [1][2]. Financing Details - The private placement will provide upfront proceeds of USD 200 million, with the potential for an additional USD 200 million through warrants [1][2]. - The financing was led by existing investor BVF Partners L.P. and included participation from various institutional investors [1][2]. - The company plans to use the net proceeds to fund clinical trials, operations, and general corporate purposes, with expectations to support activities through late 2027 [2]. Clinical Development Plans - Immunic aims to initiate a Phase 3 clinical program for primary progressive multiple sclerosis (PPMS) later this year, which is expected to take approximately 3.5 to 4 years to complete [1]. - The ongoing Phase 3 ENSURE trials for vidofludimus calcium in relapsing multiple sclerosis (RMS) are expected to yield top-line data by the end of 2026, with a New Drug Application (NDA) submission planned for mid-2027 [1][2]. Product Mechanism and Potential - Vidofludimus calcium is designed to provide neuroprotective effects and reduce inflammatory damage, addressing key biological drivers of disability progression in multiple sclerosis [1]. - The drug's mechanism involves enhancing neuronal survival through nuclear receptor-related 1 (Nurr1) activation and selective inhibition of dihydroorotate dehydrogenase (DHODH) [1]. Leadership Changes - Dr. Daniel Vitt, the co-founder and CEO, will transition to a new role focused on scientific strategy, while the search for a new CEO with commercial expertise in the MS space is underway [1][2]. - Simona Skerjanec has been appointed as the interim Chairperson of the Board of Directors, bringing significant experience from her previous role at Roche [1][2].

Financial Data and Key Metrics Changes - For the full year of 2025, total adjusted constant currency revenue growth was 13% and adjusted EBITDA growth was 26% year-over-year, resulting in positive free cash flow while investing significantly in future growth [5][15] - Total adjusted revenues for Q4 of 2025 were $118.3 million, up 18.5% compared to Q4 of 2024, with adjusted EBITDA increasing approximately 29% from $17.6 million to $22.7 million [15][16] - Adjusted EBITDA margin was 19.2% in Q4 of 2025, an improvement of approximately 110 basis points over the prior year [16] Business Line Data and Key Metrics Changes - Stent graft revenues grew 36% on a constant currency basis in Q4 compared to the same period last year, driven by AMDS in the U.S. and strong international growth [6][19] - On-X revenues increased 24% year-over-year on a constant currency basis, supported by global market share gains and new U.S. market opportunities [7][8] - Tissue processing revenue increased 6% year-over-year on a constant currency basis, while BioGlue revenues were flat compared to the same period last year [8][19] Market Data and Key Metrics Changes - Revenues in Asia Pacific increased 32%, North America increased 18%, EMEA increased 17%, and Latin America increased 9% compared to Q4 of 2024 [20] - Q4 gross margins were 63% in both 2025 and 2024, with the 2024 gross margin negatively impacted by an idle plant charge due to a cybersecurity incident [20] Company Strategy and Development Direction - The company plans to replicate its proven strategy by introducing additional stent graft products already generating revenue in Europe to the U.S. and Japan, aiming to expand the total addressable market [7] - Future growth is expected to be driven by AMDS commercialization in the U.S., On-X heart valve data, NEXUS PMA, and the ARTISAN IDE trial [32][33] Management's Comments on Operating Environment and Future Outlook - Management expressed confidence in delivering sustainable double-digit revenue growth and driving EBITDA margin expansion, with expectations for constant currency growth between 10%-14% for 2026 [23][26] - The company anticipates challenges in the second and third quarters of 2026 due to tougher comparisons and recovery of the tissue backlog [25] Other Important Information - The company recorded a $2.3 million adjustment to revenue for estimated payback obligations due to Italian government legislation, which has been excluded from adjusted revenue [17][18] - Free cash flow for the full year was approximately $1 million, despite significant investments in the business [22] Q&A Session Summary Question: Impact of Italian clawback on growth - The Italian clawback was specific to the EMEA line and did not impact major product lines, thus not skewing growth rates [36][38] Question: Commentary on AMDS sell-in versus sell-through - Management does not typically break out details on AMDS revenue but noted that implantations are continuing to grow positively [40][41] Question: Progress on AMDS target accounts - The company is in the early stages of AMDS rollout, with significant opportunities to open new accounts and increase implants in existing accounts in 2026 [44][45] Question: Market opportunity for NEXUS - The NEXUS device is positioned in a nascent market with a $150 million U.S. opportunity, and the company believes it is well-positioned against competitors [46][48] Question: Pricing for AMDS and NEXUS - The company sees strong demand for AMDS and NEXUS at their current price points, supported by favorable reimbursement dynamics [54] Question: CapEx plans for 2026 - CapEx is expected to be approximately $50 million in 2026, primarily for capacity expansion and IT system improvements [71][72]

Core Insights - The company demonstrated strong fourth-quarter performance in 2025, with a growth portfolio that increased by 15% year-over-year, contributing significantly to overall revenue [1][15] - The company is focused on executing a multiyear plan aimed at long-term growth, entering 2026 with positive momentum [1][12] - The company anticipates 2026 revenue between $46 billion and $47.5 billion, driven by strong performance from its growth portfolio despite a projected decline in its legacy portfolio [12][13] Financial Performance - Total revenue for Q4 2025 was approximately $12.5 billion, with the growth portfolio accounting for nearly 60% of total revenue [15] - Key brands such as Reblozyl, Breyanzi, and Camzyos showed significant growth, with Breyanzi's revenue up 47% and Camzyos growing 57% [18][19] - The company achieved approximately $1 billion in cost savings in 2025, with plans to realize an additional $1 billion in 2026 and 2027 [20][49] Product Development and Pipeline - Breyanzi received FDA approval for additional cancer types, enhancing its market position [6] - The company has multiple pivotal studies planned for 2026, with expectations for significant data readouts that could enhance the growth profile of its portfolio [10][30] - The company is focusing on expanding its product offerings in oncology, immunology, and neuroscience, with several new medicines expected to launch by 2030 [8][11] Market Dynamics - Eliquis is projected to grow by 10% to 15% in 2026, driven by increased global demand and a recent price reduction that enhances patient access [13][40] - The company anticipates a revenue decline of $1.5 billion to $2 billion for Eliquis in 2027 due to generic competition, which is expected to impact its overall revenue [25][82] - The company is strategically focused on business development opportunities that align with its existing therapeutic areas, while also considering new market expansions [39][44]

Core Viewpoint - Mereo BioPharma is updating its cash runway guidance and providing insights into its ongoing clinical programs, particularly focusing on setrusumab for osteogenesis imperfecta and alvelestat for alpha-1 antitrypsin deficiency-associated lung disease [1][2][3]. Group 1: Setrusumab Program - The Phase 3 Orbit and Cosmic studies of setrusumab did not achieve statistical significance for the primary endpoints related to fracture reduction compared to placebo or bisphosphonates, but showed significant improvement in bone mineral density as a key secondary endpoint [4]. - The safety profile of setrusumab remains consistent with previous studies, and further analyses are ongoing to determine the next steps, including potential regulatory interactions [5][4]. - There is a high unmet medical need for treatments in osteogenesis imperfecta, with no FDA or EMA approved therapies available, highlighting the importance of setrusumab in addressing this condition [6][7]. Group 2: Alvelestat Program - Mereo is advancing preparations for a global Phase 3 pivotal study of alvelestat, which is expected to enroll approximately 220 patients over an 18-month treatment period [8]. - The primary efficacy endpoint for U.S. approval will be the St. George's Respiratory Questionnaire Total Score, while lung density measured by CT scan will serve as the primary endpoint for potential European regulatory approval [9]. - The company is actively engaging in discussions with potential partners for the development and commercialization of alvelestat [9]. Group 3: Financial Position - As of December 31, 2025, Mereo reported a cash balance of approximately $41 million, which is expected to fund operations until mid-2027 [1][2].

Core Viewpoint - Athira Pharma, Inc. has rebranded as LeonaBio, Inc. to reflect its strategic focus on developing lasofoxifene for metastatic breast cancer treatment, currently in Phase 3 trials [1][2] Company Overview - LeonaBio is a clinical-stage biopharmaceutical company focused on innovative therapeutics for diseases with high unmet medical needs, including metastatic breast cancer and amyotrophic lateral sclerosis (ALS) [10] - The company aims to advance a pipeline of late-stage assets to maximize clinical and commercial impact [2] Name and Ticker Change - The name change to LeonaBio symbolizes strength and resilience, aligning with the company's mission to support patients facing serious diseases [2] - The new ticker symbol "LONA" will be effective on January 12, 2026, on The Nasdaq Capital Market [1] Lead Drug Candidates - Lasofoxifene and ATH-1105 are the lead drug candidates, targeting treatment-resistant metastatic breast cancer and ALS, respectively [3][10] - Lasofoxifene is in a Phase 3 trial (ELAINE-3) with over 50% enrollment, and data is expected in mid-2027 [3][6] Licensing and Financing - LeonaBio secured an exclusive global license for lasofoxifene from Sermonix Pharmaceuticals, excluding Asia and certain Middle Eastern countries [4] - The company raised $90 million through a private placement, with potential additional funding of up to $146 million from warrants, to support lasofoxifene's development [4] Drug Candidate Details - Lasofoxifene is a selective estrogen receptor modulator (SERM) designed to target both wild-type and mutant estrogen receptors, addressing a critical unmet need in metastatic breast cancer [5] - ATH-1105 is a next-generation small molecule aimed at treating neurodegenerative diseases, currently in Phase 1 trials with plans for a Phase 2 trial in ALS patients in early 2026 [7][8]

Summary of Athira Pharma Conference Call - December 18, 2025 Company Overview - **Company**: Athira Pharma (NasdaqGS:ATHA) - **Focus**: Development of innovative therapies for diseases with unmet medical needs, specifically in oncology and neurology Key Points Discussed Transformative Acquisition - Athira announced the acquisition of rights to develop and commercialize **lasofoxifene**, a potential treatment for metastatic breast cancer, which diversifies its pipeline with a late-stage program [5][15][16] - The acquisition is expected to enhance Athira's mission to deliver transformative therapies for patients [5][14] Lasofoxifene Overview - Lasofoxifene is currently in a pivotal phase III clinical trial targeting **ER-positive HER2-negative metastatic breast cancer**, which represents about 70% of all breast cancer cases [15][16] - The global market for metastatic ER-positive HER2-negative breast cancer is projected to grow from **$10.9 billion in 2025 to over $15.9 billion by 2029** [15] - Lasofoxifene has shown promising clinical activity, achieving **13 months of progression-free survival (PFS)** in combination therapy during phase II trials [20][26] Clinical Data and Mechanism - Lasofoxifene demonstrated an **83% reduction in new-onset primary wild-type estrogen receptor-positive breast cancer** in previous studies [19] - It modulates the estrogen receptor rather than degrading it, providing tissue selectivity and sparing healthy estrogen receptors in critical tissues [19][21] - The drug has shown **significant efficacy against ESR1 mutations**, which occur in over 40% of patients and are a major mechanism of resistance in breast cancer treatments [20][21] ATH-1105 for ALS - Athira is also advancing **ATH-1105**, a potential treatment for **Amyotrophic Lateral Sclerosis (ALS)**, which affects approximately **33,000 patients in the U.S.** [37] - ATH-1105 modulates the hepatocyte growth factor (HGF) system, which is critical for neuronal health [38] - Preclinical studies have shown that ATH-1105 preserves motor function and reduces neurodegeneration in ALS models [39][40] Financial and Strategic Positioning - Athira raised **$90 million** to support its development programs, with the potential for an additional **$146 million** through warrants [46] - The financing positions the company to reach critical data readouts across both programs by the end of **2027** [46] - Athira aims to achieve peak annual U.S. sales for lasofoxifene approaching **$1 billion** if approved [35] Market Opportunity - The global breast cancer market is approximately **$55 billion**, with the second-line breast cancer segment in the U.S. exceeding **$5-$6 billion annually** [34] - Lasofoxifene's favorable tolerability profile and unique attributes position it as a potential leading therapy in this market [35][36] Conclusion - Athira is committed to advancing its promising development programs for lasofoxifene and ATH-1105, addressing significant unmet needs in metastatic breast cancer and ALS [45] - The company is optimistic about its future and the potential impact of its therapies on patient outcomes [47]

Core Insights - Insmed Incorporated announced that the Phase 2b BiRCh study of brensocatib in chronic rhinosinusitis without nasal polyps (CRSsNP) did not meet its primary or secondary efficacy endpoints, leading to the discontinuation of the development program for this indication [1][2][4] - The company has acquired INS1148, a Phase 2 ready monoclonal antibody aimed at treating respiratory and immunological diseases, which is expected to advance into clinical development [3][4] Study Results - The Phase 2b BiRCh study involved 288 patients randomized to receive either brensocatib 10 mg, 40 mg, or placebo for 24 weeks, with the primary endpoint being the change in the 28-day average of daily Sinus Total Symptom Score (sTSS) at Week 24 [4][5] - Topline results showed that the placebo group had a least squares mean change of -2.44, while the brensocatib 10 mg and 40 mg groups had changes of -2.21 and -2.33, respectively, indicating no significant improvement [2][4] - Treatment-emergent adverse events (TEAEs) were reported as follows: 63.6% for 10 mg, 69.9% for 40 mg, and 65.3% for placebo, with serious TEAEs being 2.0%, 3.2%, and 2.1% respectively [2] Acquisition Details - INS1148 is an investigational monoclonal antibody with a novel mechanism targeting a specific isoform of Stem Cell Factor SCF248, which may address significant unmet needs in respiratory and inflammatory diseases [3][4] - The company plans to initiate Phase 2 development programs for INS1148 in interstitial lung disease and moderate-to-severe asthma [3][4] Company Overview - Insmed is a biopharmaceutical company focused on delivering innovative therapies for serious diseases, with a diverse portfolio that includes both approved and investigational medicines [6][7] - The company has been recognized as a top employer in the biopharmaceutical industry, emphasizing its commitment to patient care and innovative drug development [7]

Core Insights - Veru Inc. is a late clinical stage biopharmaceutical company focused on developing innovative medicines for cardiometabolic and inflammatory diseases [3] - The company will host a conference call on December 17, 2025, to discuss its fiscal year 2025 financial results and provide a business update [1] Company Overview - Veru's drug development program includes two late-stage novel small molecules: enobosarm and sabizabulin [3] - Enobosarm is a selective androgen receptor modulator (SARM) aimed at enhancing weight reduction by making GLP-1 RA drugs more tissue-selective for fat loss while preserving lean mass [3] - Sabizabulin is being developed for treating inflammation in atherosclerotic cardiovascular disease [3] Clinical Studies - The Phase 2b QUALITY clinical study demonstrated that enobosarm combined with semaglutide led to greater fat loss and preservation of lean mass in older patients [4] - The upcoming Phase 2b PLATEAU clinical study will evaluate enobosarm's effect on total body weight and physical function in approximately 200 patients with obesity [5] - The primary efficacy endpoint of the PLATEAU study is the percent change in total body weight at 72 weeks, with an interim analysis at 36 weeks [5]