Core Viewpoint - CoinShares has withdrawn registration filings for its XRP, Solana-staking, and Litecoin ETFs, coinciding with preparations for a Nasdaq listing [1] Group 1 - The withdrawal of the ETF registrations indicates a strategic shift by CoinShares as it approaches a significant market event [1] - The decision to pull these altcoin products may reflect regulatory challenges or market conditions affecting the cryptocurrency sector [1] - CoinShares is positioning itself for a Nasdaq listing, which could enhance its visibility and credibility in the financial markets [1]

Core Insights - The article discusses Celcuity (CELC) and its stock price, which is perceived to be fundamentally discounting its risk/reward ratio, indicating skepticism around the toxicities associated with oral PI3K inhibitors [1] Group 1: Company Analysis - Celcuity is characterized as a speculative play, reflecting deep skepticism regarding its product's safety profile [1] - The company is positioned in a high-growth sector, with potential for exponential expansion due to its focus on disruptive technologies [1] Group 2: Investment Approach - The investment strategy emphasizes a combination of fundamental analysis and future trend prediction, highlighting the belief in innovation as a driver for substantial returns [1]

Core Insights - The article discusses Celcuity (CELC) and its stock price, which is perceived to be fundamentally discounting its risk/reward ratio, indicating skepticism around the toxicities associated with oral PI3K inhibitors [1] Group 1: Company Analysis - Celcuity is characterized as a speculative play, reflecting deep skepticism regarding its product's safety profile [1] - The focus is on high-growth companies, particularly in sectors expected to experience exponential expansion, highlighting the importance of innovation in generating substantial returns [1] Group 2: Investment Approach - The investment strategy combines fundamental analysis with future trend predictions, emphasizing the potential of disruptive technologies and forward-thinking enterprises [1]

Core Insights - Apis Capital Advisors has initiated a new position in Celcuity Inc., acquiring 776,000 shares valued at $38.33 million as of September 30, representing 8.5% of the fund's total U.S. equity assets of $452.7 million [2][7] - Celcuity's stock has surged 669% over the past year, significantly outperforming the S&P 500's 13% gain during the same period [3] - The company specializes in precision oncology solutions, focusing on personalized treatment for advanced or metastatic breast and ovarian cancer [5] Company Overview - Celcuity Inc. has a market capitalization of $4.6 billion and a share price of $100.35 as of the latest market close [4] - The company reported no revenue and a net income loss of $162.7 million for the trailing twelve months [4] - Celcuity's lead candidate, Gedatolisib, and the CELsignia diagnostic platform are central to its strategy of targeting abnormal cellular signaling in cancer [5] Recent Developments - Following positive phase 3 results for Gedatolisib, Celcuity submitted a new drug application to the FDA on November 17 [8] - The company's momentum is attributed to rapid clinical and platform progress, aiming to address complex cancer treatment challenges [8] - Investors view Celcuity as one of the most promising stories in precision oncology for the year, reflecting growing confidence in its scientific approach [6]

Core Insights - Celcuity Inc. announced the acceptance of an abstract for an oral presentation at the 2025 San Antonio Breast Cancer Symposium (SABCS), highlighting its ongoing research in targeted therapies for oncology [1][2]. Company Overview - Celcuity is a clinical-stage biotechnology company focused on developing targeted therapies for multiple solid tumor indications, with its lead candidate being gedatolisib, a potent pan-PI3K and mTORC1/2 inhibitor [3]. - Gedatolisib targets the PI3K/AKT/mTOR pathway, differentiating its mechanism of action and pharmacokinetic properties from other therapies that target PI3Kα, AKT, or mTORC1 alone or in combination [3]. Clinical Trials - The VIKTORIA-1 trial, a Phase 3 clinical study, has completed enrollment and is evaluating gedatolisib in combination with fulvestrant with or without palbociclib for patients with HR+/HER2- advanced breast cancer [3]. - The company has reported detailed results for the PIK3CA wild-type cohort and has also completed enrollment for the PIK3CA mutant cohort [3]. - A second Phase 3 trial, VIKTORIA-2, is currently enrolling patients to evaluate gedatolisib plus a CDK4/6 inhibitor and fulvestrant as a first-line treatment for HR+/HER2- advanced breast cancer [3]. - Additionally, a Phase 1/2 trial, CELC-G-201, is ongoing to assess gedatolisib in combination with darolutamide for metastatic castration-resistant prostate cancer [3].

Core Insights - Celcuity Inc. is participating in the 8th Annual Evercore Healthcare Conference from December 2-4, 2025, in Miami, Florida [1] - CEO Brian Sullivan will have a fireside chat on December 3, 2025, at 7:30 a.m. ET, with a live webcast available [2] 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 [3] - Ongoing clinical trials include VIKTORIA-1, which has completed enrollment for both PIK3CA wild-type and mutant cohorts, and VIKTORIA-2, which is currently enrolling patients [3] - A Phase 1/2 trial, CELC-G-201, is evaluating gedatolisib in combination with darolutamide for metastatic castration-resistant prostate cancer [3]

Company Overview - Celcuity Inc. is a biotechnology company focused on developing diagnostic tests for cancer patients, aiming to identify effective therapies tailored to individual needs [1] Financial Performance - Celcuity's Return on Invested Capital (ROIC) is -36.46%, significantly lower than its Weighted Average Cost of Capital (WACC) of 4.88%, indicating negative returns on invested capital [2] - The ROIC to WACC ratio for Celcuity is -7.47, showing that returns are well below the cost of capital [2] Peer Comparison - Crinetics Pharmaceuticals has a ROIC of -42.35% and a WACC of 4.55%, resulting in a ROIC to WACC ratio of -9.30, which is less negative than Celcuity's, suggesting it is closer to covering its cost of capital [3] - Evelo Biosciences has a ROIC of -201.37% and a WACC of 9.04%, leading to a ROIC to WACC ratio of -22.28, indicating a more severe situation than Celcuity [4] - Scholar Rock Holding Corporation and Cue Biopharma report negative ROICs of -101.98% and -151.57%, respectively, with ROIC to WACC ratios of -15.01 and -15.31, reflecting a common trend among clinical-stage biotech companies facing negative returns due to high R&D investments and limited revenue generation [5]

Core Insights - Celcuity Inc. (NASDAQ:CELC) is gaining attention as a leading SMID-cap stock in 2025, with Wolfe Research initiating coverage on November 17, giving it an Outperform rating and a price target of $110 [1][2]. Clinical Progress - The company has shown strong momentum following the successful Phase 3 trial of gedatolisib for second-line PIK3CA-WT breast cancer, which is expected to be a key catalyst with the upcoming PIK3CA-mt readout in 2026 [2]. - Celcuity submitted its New Drug Application (NDA) for gedatolisib to the U.S. FDA on the same day as the coverage initiation [3]. Trial Results - Detailed results from the Phase 3 VIKTORIA-1 clinical trial presented at the ESMO Congress indicated a significant efficacy of gedatolisib, showing up to a 76% reduction in the risk of disease progression or death in the PIK3CA WT cohort [4]. Strategic Positioning - The continued clinical advancements have enhanced Celcuity's strategic value, making it an attractive acquisition target for larger pharmaceutical companies [2].

Core Insights - Celcuity Inc. has submitted a New Drug Application (NDA) for gedatolisib to the FDA for the treatment of hormone receptor positive, HER2-negative advanced breast cancer, under the Real-Time Oncology Review program, aiming for expedited regulatory review [1][2] - The NDA submission is based on positive clinical results from the Phase 3 VIKTORIA-1 trial, showing significant efficacy improvements with gedatolisib compared to standard treatments [2][3] Company Overview - Celcuity is a clinical-stage biotechnology company focused on developing targeted therapies for various solid tumors, with gedatolisib as its lead candidate [5][6] - Gedatolisib is a multi-target PI3K/AKT/mTOR inhibitor that comprehensively blocks the PAM pathway, differentiating it from single-target inhibitors [3][5] Clinical Trial Results - The gedatolisib-triplet therapy reduced the risk of disease progression or death by 76% compared to fulvestrant, with a median progression-free survival (PFS) of 9.3 months versus 2.0 months, an improvement of 7.3 months [2] - The gedatolisib-doublet therapy reduced the risk of disease progression or death by 67%, with a median PFS of 7.4 months compared to 2.0 months with fulvestrant, an improvement of 5.4 months [2] Regulatory Context - The FDA's Real-Time Oncology Review program aims to streamline the review process for oncology drugs, ensuring timely access to safe and effective treatments [4]

Drug Development and Clinical Trials - Gedatolisib is a pan-class I isoform PI3K inhibitor with low nanomolar potency for p110α, p110β, p110γ, and p110δ isoforms, and mTORC1 and mTORC2 complexes, providing comprehensive inhibition of the PAM pathway[93]. - In the Phase 1b clinical trial, the overall response rate (ORR) for treatment-naïve patients with advanced breast cancer was 85%, while the ORR for patients who received prior hormonal therapy ranged from 36% to 77%[99]. - The median progression-free survival (PFS) for treatment-naïve patients receiving gedatolisib combined with palbociclib plus letrozole was 48.6 months[100]. - As of September 30, 2025, 492 patients with solid tumors have received gedatolisib across eight completed clinical trials[97]. - The VIKTORIA-1 Phase 3 trial has completed enrollment of 351 subjects for the PIK3CA wild-type cohort, with primary completion achieved in May 2025[108]. - The Phase 3 trial VIKTORIA-2 is currently enrolling patients, evaluating gedatolisib in combination with a CDK 4/6 inhibitor and fulvestrant for advanced breast cancer[91]. - The median PFS for patients with PIK3CA mutant tumors was 14.6 months, with an ORR of 48%[104]. - Topline data for the PIK3CA mutant cohort of the VIKTORIA-1 trial is expected to be available in late Q1 2026 or Q2 2026[108]. - The gedatolisib triplet demonstrated a median progression-free survival (PFS) of 9.3 months, an improvement of 7.3 months over fulvestrant, with a hazard ratio (HR) of 0.24, indicating a 76% reduction in the risk of disease progression or death[109]. - The gedatolisib doublet showed a median PFS of 7.4 months, an improvement of 5.4 months over fulvestrant, with a HR of 0.33, indicating a 67% reduction in the risk of disease progression or death[109]. - The overall response rate (ORR) for the gedatolisib triplet was 31.5%, with a median duration of response (DOR) of 17.5 months, while the ORR for the gedatolisib doublet was 28.3% with a median DOR of 12.0 months[109]. - The CELC-G-201 Phase 1b trial reported a six-month radiographic progression-free survival (rPFS) rate of 67% and a median rPFS of 9.1 months across both treatment arms[118]. Financial Performance and Expenses - The company reported a net loss of approximately $43.8 million for the three months ended September 30, 2025, compared to a net loss of $29.8 million for the same period in 2024[128]. - As of September 30, 2025, the company had an accumulated deficit of approximately $397.9 million and cash and cash equivalents of approximately $455.0 million[128]. - Research and development expenses for Q3 2025 were approximately $34.9 million, an increase of 27% compared to Q3 2024[140]. - General and administrative expenses for Q3 2025 were approximately $7.9 million, reflecting a significant increase of 221% compared to Q3 2024[143]. - Total operating expenses for Q3 2025 reached $42.8 million, a 43% increase from $30.1 million in Q3 2024[137]. - Research and development expenses for the nine months ended September 30, 2025, were approximately $107.4 million, a 52% increase from $70.7 million in the same period of 2024[141]. - Total operating expenses for the nine months ended September 30, 2025, were $123.0 million, a 60% increase compared to $76.8 million in the same period of 2024[139]. - Interest expense for Q3 2025 was $4.6 million, a 37% increase compared to $3.3 million in Q3 2024[146]. Capital and Funding Activities - The company completed an equity offering of 1,836,842 shares at $38.00 per share, raising approximately $69.7 million[123]. - The company raised approximately $481.7 million through equity securities and $194.9 million through the issuance of convertible notes since inception[150]. - The company completed an equity offering in July 2025, generating approximately $91.6 million in net proceeds for working capital and general corporate purposes[152]. - The company received net proceeds of approximately $27.8 million from the disbursement of the $30.0 million Term D Loan[166]. - The company achieved the Term D Milestone, allowing for the draw of an additional $30.0 million of indebtedness under the Term D Loan[171]. - The company is entitled to make interest-only payments for up to 48 months under the A&R Loan Agreement, with interest rates starting at 7.75% plus 2.85%[175]. - The company recognized a Final Fee of $4.5 million as additional debt principal, which will be amortized over the life of the loan[176]. Future Outlook and Risks - The company expects research and development expenses to increase as it continues to develop gedatolisib and conduct multiple clinical trials[179]. - The company believes its current cash and available borrowings will be sufficient to finance operations through 2027[180]. - The company may seek to raise additional capital through equity or convertible debt securities, which could result in dilution to stockholders[181]. - The company is facing known and unknown risks that may cause actual results to differ materially from forward-looking statements[196]. - There are uncertainties and costs associated with the development and commercialization of gedatolisib, which may impact timely regulatory approval[196]. - The company may encounter challenges in maintaining relationships with pharmaceutical partners and suppliers[196]. - Market acceptance by physicians, patients, and payors remains uncertain, affecting potential market opportunities[196]. - The company is subject to risks related to hiring and retaining qualified personnel, which could impact growth management[196]. - Changes in government regulations and tightening credit markets may affect capital access[196]. - The company has no obligation to update forward-looking statements unless required by law[197]. - As a smaller reporting company, the company is not required to provide specific market risk disclosures[198].