Group 1 - The article does not provide any relevant content regarding company or industry insights [1]

Core Insights - Celcuity Inc. has appointed Charles (Chip) R. Romp to its Board of Directors, bringing over 25 years of experience in the pharmaceutical industry, particularly in oncology [1][2] - Mr. Romp's expertise in commercializing significant oncology drugs is expected to provide valuable insights as Celcuity advances its programs and prepares for the potential approval and launch of gedatolisib later this year [2][3] Company Overview - Celcuity is a clinical-stage biotechnology company focused on developing targeted therapies for multiple solid tumor indications [3] - The lead therapeutic candidate, gedatolisib, is a potent pan-PI3K and mTORC1/2 inhibitor that blocks the PI3K/AKT/mTOR pathway comprehensively [3] - Celcuity is conducting several clinical trials, including a Phase 3 trial (VIKTORIA-1) for gedatolisib in combination with fulvestrant for HR+/HER2- advanced breast cancer, which has completed enrollment [3] - Another Phase 3 trial (VIKTORIA-2) is currently enrolling patients, evaluating gedatolisib plus a CDK4/6 inhibitor and fulvestrant as first-line treatment for HR+/HER2- advanced breast cancer [3] Leadership Experience - Mr. Romp is currently the CEO of Secura Bio and previously served as Executive Vice President, Commercial U.S., at Seagen, Inc., overseeing the entire commercial organization [2] - He has a history of managing the growth of key oncology products such as ADCETRIS, PADCEV, TUKYSA, and TIVDAK at Seagen [2] - Prior to Seagen, Mr. Romp held senior sales leadership positions at Genentech, responsible for oncology and immunology products [2]

Summary of Celcuity Conference Call Company Overview - **Company**: Celcuity - **Product**: Gedatolisib - **Industry**: Healthcare, specifically oncology Key Points Product Development and Approval Timeline - Celcuity has received positive phase 3 data for gedatolisib in breast cancer and has an NDA accepted with a PDUFA date set for July 17, 2024, indicating a potential launch soon after approval [3][4] - Data for the mutant cohort of the VIKTORIA-1 study is expected to be available later this quarter or in Q2 2024 [4] Commercial Infrastructure - The Chief Commercial Officer was appointed in Q1 2024, with plans to prepare for a mid-2026 launch [7] - The commercial organization is being built out, with hiring in marketing, commercial operations, and medical affairs largely completed, leaving only field sales representatives to be hired [7][8] Clinical Data and Efficacy - Gedatolisib has shown a hazard ratio of 0.24, translating to a 76% reduction in the risk of progression or death compared to endocrine therapy, which is unprecedented [12] - The drug's efficacy is expected to be superior to existing options, with a nearly 5-fold improvement in progression-free survival (PFS) [12] Patient Experience and Side Effects - Stomatitis is a common side effect but tends to resolve within two weeks, with patients reporting a good sense of well-being while on the drug [16][17] - Gedatolisib's pharmacokinetics allow for dosing three times a month, maintaining effective drug levels while minimizing adverse effects [18][19] Market Opportunity - The overall market for gedatolisib is estimated to exceed $6 billion, with a potential of over $2 billion in the second-line indication alone at a 30% market penetration [35][36] - The drug could become a multi-billion dollar product, especially if successful in first-line settings [37] Ongoing Trials and Future Prospects - The ongoing trial for the treatment-naive population is focused on women who are endocrine resistant, with a safety run-in phase expected to conclude soon [40][41] - The company is optimistic about the results from the VIKTORIA-1 study, which showed significant benefits even in patients with prior CDK treatment [43][44] Financial Position - Celcuity reported $450 million in cash at the end of Q3 and has access to an additional $500 million through a term loan facility, providing flexibility for future operations [48] Additional Insights - The company is confident in its ability to execute the commercial launch of gedatolisib and is focused on building the necessary infrastructure [23][24] - The competitive landscape includes drugs like Truqap, which has a median PFS of 5.5 months, suggesting that gedatolisib could offer significant advantages in terms of efficacy [32][35]

Core Insights - Celcuity Inc. is a clinical-stage biotechnology company focused on developing targeted therapies for oncology, specifically for multiple solid tumor indications [3] - The company will participate in the Guggenheim Emerging Outlook: Biotech Summit 2026 in New York on February 11-12, 2026 [1] - Brian Sullivan, CEO and Co-founder of Celcuity, is scheduled for a fireside chat on February 11, 2026, at 9:30 a.m. ET, with a live webcast available [2] Company Overview - Celcuity's lead therapeutic candidate is gedatolisib, a potent pan-PI3K and mTORC1/2 inhibitor that targets the PI3K/AKT/mTOR pathway [3] - The company has completed enrollment for the Phase 3 clinical trial VIKTORIA-1, which evaluates gedatolisib in combination with fulvestrant in patients with HR+/HER2- ABC, and has reported results for the PIK3CA wild-type cohort [3] - The ongoing Phase 3 clinical trial VIKTORIA-2 is assessing gedatolisib plus a CDK4/6 inhibitor and fulvestrant as first-line treatment for HR+/HER2- ABC patients [3] - A Phase 1/2 clinical trial, CELC-G-201, is evaluating gedatolisib in combination with darolutamide for metastatic castration-resistant prostate cancer [3]

Performance Summary - Apis Flagship Fund achieved a net return of 10.0% in Q4 2025 and a total gain of 55.1% for the year, outperforming the MSCI ACWI benchmark by approximately 7.0% in Q4 and 33.0% for the year [1] - Long positions contributed 11.9% gross to the fund's performance, while short positions added 0.8% gross, with a net long position of around 68% as of December [1] - The performance was broad-based, with Technology and Healthcare sectors leading returns, and basic materials also contributing positively [1] Stock Focus: Celcuity Inc - Celcuity Inc (NASDAQ:CELC) is a clinical-stage biotechnology company focused on precision oncology therapies, utilizing the CELsignia platform to identify suitable cancer patients for targeted treatments [2] - The stock of Celcuity Inc had a one-month return of 5.41%, trading between $7.58 and $120.32 over the past 52 weeks, and closed at approximately $109.42 per share on January 30, 2026, with a market capitalization of about $5.06 billion [2] - Celcuity Inc was the top contributor to the fund's performance in Q4, adding 3.8% during the quarter and 4.4% for the full year [3] Investment Strategy - The firm emphasized a continued focus on bottom-up stock selection and structural exposures to niche opportunities in healthcare, semiconductors, and industrials as key drivers for future returns [1] - The attractiveness of non-U.S. markets is highlighted as a significant factor for potential future gains [1]

Investment Rating - The report maintains a strong rating for the pharmaceutical sector, indicating it is expected to outperform the market [6]. Core Insights - The targeted PAM pathway represents a potential market of approximately $10 billion, with significant implications for breast and prostate cancer treatments [4][16]. - Celcuity's Gedatolisib is highlighted as a promising PAM inhibitor, showing comparable efficacy to existing therapies and is under FDA priority review with a PDUFA date set for July 17, 2026 [4][37]. - The report emphasizes the importance of innovation and international expansion in the pharmaceutical industry, suggesting that companies focusing on these areas will likely thrive [4]. Summary by Sections Targeted PAM Pathway - The PAM pathway is identified as one of the most underdeveloped targets in solid tumors, with mutations occurring in 38% of cancer patients [4][16]. - Gedatolisib is noted for its effectiveness across various PI3K subtypes and its potential to establish new treatment standards in HR+/HER2- advanced breast cancer [25][37]. - HMPL-A251, developed by Hutchison China MediTech, is a HER2-targeted PAM inhibitor that has shown strong anti-tumor activity in both HER2-positive and low-expressing tumors [41][50]. Market Review and Trends - The report reviews the performance of the pharmaceutical sector from January 26 to January 30, 2026, noting a decline of 3.3% in the CITIC Pharmaceutical Index, which underperformed the CSI 300 Index by 3.4 percentage points [3][60]. - The report highlights the best-performing stocks during this period, including Cap Bio (+26.5%) and Hualan Biological (+12.8%) [3][74]. - The overall valuation of the pharmaceutical sector as of January 30, 2026, is reported at 29.09, reflecting a slight decrease of 0.87% [69].

Core Insights - Celcuity Inc. has rapidly reached a mature valuation of just over $5 billion in market capitalization, indicating significant growth in a short period [1] Company Overview - The company operates in the biotech sector, focusing on analyzing clinical trials and developing innovative solutions [1]

Core Viewpoint - The FDA has accepted Celcuity Inc.'s New Drug Application for gedatolisib, granting it Priority Review with a PDUFA goal date of July 17, 2026, for the treatment of HR+/HER2- advanced breast cancer [1][2][3]. Group 1: FDA Review and Application - The New Drug Application (NDA) for gedatolisib was submitted under the FDA's Real-Time Oncology Review (RTOR) program, aimed at expediting regulatory review periods [2]. - Gedatolisib has previously received Breakthrough Therapy and Fast Track designations due to promising preliminary clinical data [2]. - The NDA submission is based on clinical data from the PIK3CA wild-type cohort of the Phase 3 VIKTORIA-1 clinical trial [2]. Group 2: Product Details - Gedatolisib is a multi-target PI3K/AKT/mTOR inhibitor that targets all four Class I PI3K isoforms, mTORC1, and mTORC2, providing comprehensive blockade of the PAM pathway [4]. - The mechanism of action of gedatolisib is differentiated from currently approved single-target inhibitors, allowing for full suppression of the PAM pathway [4]. - Nonclinical studies and early clinical data indicate that gedatolisib demonstrates comparable potency and cytotoxicity in both PIK3CA-mutant and wild-type breast tumor cells [4]. Group 3: Company Overview - Celcuity is a clinical-stage biotechnology company focused on developing targeted therapies for various solid tumor indications, with gedatolisib as its lead candidate [5]. - The company has completed enrollment for the PIK3CA wild-type cohort in the VIKTORIA-1 trial and is currently enrolling patients for the PIK3CA mutant cohort [5]. - A Phase 3 clinical trial, VIKTORIA-2, is ongoing, evaluating gedatolisib in combination with a CDK4/6 inhibitor and fulvestrant as first-line treatment for HR+/HER2- advanced breast cancer [5].

Core Insights - Artificial intelligence (AI) is identified as the greatest investment opportunity of the current era, with a strong emphasis on the urgent need for energy to support its growth [1][2][3] Group 1: AI and Energy Demand - AI technologies, particularly large language models like ChatGPT, are extremely energy-intensive, with data centers consuming as much energy as small cities [2] - The increasing demand for AI is straining global power grids, leading to rising electricity prices and a need for utilities to expand capacity [2] - Industry leaders, including Sam Altman and Elon Musk, have highlighted the critical link between AI development and energy availability, warning of potential shortages [2] Group 2: Investment Opportunity - A specific company, largely overlooked by AI investors, is positioned to capitalize on the anticipated surge in energy demand from AI data centers [3][6] - This company owns essential energy infrastructure assets and is involved in the engineering, procurement, and construction (EPC) of large-scale projects across various energy sectors [7] - It is uniquely positioned to benefit from the U.S. LNG export market, which is expected to grow under the current administration's energy policies [7] Group 3: Financial Strength and Market Position - The company is debt-free and has significant cash reserves, amounting to nearly one-third of its market capitalization, providing it with a strong financial foundation [8] - It also holds a substantial equity stake in another AI-related company, offering investors indirect exposure to multiple growth opportunities without high premiums [9] - The stock is currently trading at less than 7 times earnings, making it an attractive investment compared to other firms in the sector [10] Group 4: Future Trends and Talent Pool - The ongoing influx of talent into the AI sector is expected to drive continuous innovation and advancements, reinforcing the importance of investing in AI [12] - The convergence of AI, energy infrastructure, and onshoring trends presents a unique investment landscape that savvy investors are beginning to recognize [6][14]

Core Insights - Celcuity (CELC) has made significant clinical and regulatory progress, submitting a new drug application (NDA) for gedatolisib to the FDA for HR+, HER2- advanced breast cancer, with a decision expected in 2026 [1][8] - Gedatolisib is a multi-target PAM inhibitor that blocks the PAM pathway, distinguishing it from existing single-target inhibitors [2] - The NDA is based on positive data from the phase III VIKTORIA-1 study, showing significant improvements in median progression-free survival (PFS) for gedatolisib compared to fulvestrant [3] Clinical Data - The VIKTORIA-1 study demonstrated that gedatolisib achieved 7.3 months and 5.4 months of incremental PFS improvements over fulvestrant for the triplet and doublet therapies, respectively [3] - These PFS improvements are the highest reported in phase III studies for HR+, HER2- advanced breast cancer patients receiving second-line endocrine therapy [3] Market Potential - There is a significant unmet need for more effective therapies for HR+, HER2- advanced breast cancer patients previously treated with a CDK4/6 inhibitor [4] - Celcuity's efficacy results have led to a stock price increase of 677.4% over six months, significantly outperforming the industry average increase of 21.5% [4] Ongoing Research - Enrollment is complete in the PIK3CA mutant cohort of the VIKTORIA-1 study, with top-line data expected in the first half of 2026 [6] - Additional studies on gedatolisib combinations in breast cancer and prostate cancer are ongoing [6]