Celcuity(CELC)

Search documents
Celcuity Inc. (CELC)’s FDA NDA for Gedatolisib Accepted Under RTOR, Accelerating Review
Yahoo Finance· 2025-09-30 16:47
We recently compiled a list of the 12 Best Performing Healthcare Stocks to Buy Right Now. Celcuity Inc. is one of them. Celcuity Inc. (NASDAQ:CELC) is a clinical-stage biotechnology company developing targeted oncology therapies, with a focus on solid tumors such as advanced breast cancer. Its lead drug candidate, gedatolisib, targets the PI3K and mTOR pathways, key drivers of tumor growth and resistance, aiming to improve outcomes for patients with hormone receptor-positive (HR+), HER2-negative advanced ...
12 Best Performing Healthcare Stocks to Buy Right Now
Insider Monkey· 2025-09-29 00:18
In this article, we will be taking a look at the 12 Best Performing Healthcare Stocks to Buy Right Now.Spending on healthcare in the US is predicted to hit $5.3 trillion this year, making it one of the largest in the world. Although it is frequently thought of as a defensive industry that fared better in unpredictable times, that has not been the case. Despite the general equities market’s 12% gain so far this year and its rise to record highs, the sector is down roughly 1% for the year.Over the last three ...
Celcuity to Present Results from the Pivotal Phase 3 VIKTORIA-1 Trial at the 2025 European Society for Medical Oncology (ESMO) Congress
Globenewswire· 2025-09-22 13:15
Core Insights - Celcuity Inc. announced that clinical data from the Phase 3 VIKTORIA-1 trial will be presented at the ESMO Congress, highlighting the efficacy and safety of gedatolisib in treating advanced breast cancer [1][2] Company Overview - Celcuity is a clinical-stage biotechnology company focused on developing targeted therapies for various solid tumors, with its lead candidate being gedatolisib, a pan-PI3K and mTORC1/2 inhibitor [3] - The VIKTORIA-1 trial evaluates gedatolisib in combination with fulvestrant, with or without palbociclib, specifically for patients with HR+/HER2- advanced breast cancer [3] - The company is also conducting other clinical trials, including VIKTORIA-2 and CELC-G-201, targeting different cancer indications [3]
Celcuity Announces Upsized Senior Secured Term Loan Facility of $500 Million with Innovatus Capital Partners and Oxford Finance
Globenewswire· 2025-09-09 20:01
Core Viewpoint - Celcuity Inc. has amended its senior secured credit facility, increasing the total term loan facility size to $500 million, which enhances its financial flexibility and supports its strategic initiatives in oncology [1][2]. Group 1: Credit Facility Details - The amended credit facility includes $350 million in committed capital and up to $150 million available at the mutual discretion of Celcuity and its lenders [1]. - The initial funding under the amended credit facility was $30 million, bringing the total term loan outstanding to $130 million [1]. - The facility adds $170 million in new committed capital, including $100 million available upon FDA approval of gedatolisib for specific patient groups and $120 million upon achieving certain commercial revenue milestones [6]. Group 2: Strategic Implications - The amendment enhances Celcuity's ability to manage its capital structure efficiently and provides additional funding for the rolling submission of its New Drug Application (NDA) to the FDA, as well as preparations for the commercial launch of gedatolisib [2]. - The interest-only period has been extended by 14 months, with an additional seven-month extension available upon FDA approval [6]. Group 3: 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 pan-PI3K and mTORC1/2 inhibitor [4]. - The VIKTORIA-1 Phase 3 clinical trial has completed enrollment and reported topline data for the PIK3CA wild-type cohort, while currently enrolling patients for the PIK3CA mutant cohort [4].
Celcuity to Initiate NDA Submission of Gedatolisib in PIK3CA Wild-Type Cohort in HR+/HER2- Advanced Breast Cancer Under FDA’s Real-Time Oncology Review Program
Globenewswire· 2025-08-27 20:05
Core Viewpoint - Celcuity Inc. announced that the FDA accepted its New Drug Application for gedatolisib in HR+/HER2- advanced breast cancer for review under the Real-Time Oncology Review program, facilitating an earlier evaluation process [1][2] Group 1: FDA Review and Application - The FDA's acceptance of the NDA for gedatolisib is part of the RTOR program, which allows for earlier submission of topline efficacy and safety results [1][3] - Celcuity plans to initiate a rolling submission of its NDA in September 2025, targeting completion by Q4 2025 [1][2] Group 2: Clinical Trial Results - The NDA submission is based on positive topline results from the PIK3CA wild-type cohort of the Phase 3 VIKTORIA-1 trial [2] - The gedatolisib-triplet (gedatolisib, fulvestrant, and palbociclib) 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 for fulvestrant, an improvement of 7.3 months [2] - The gedatolisib-doublet (gedatolisib and fulvestrant) reduced the risk of disease progression or death by 67%, with a median PFS of 7.4 months compared to 2.0 months for fulvestrant, an improvement of 5.4 months [2] Group 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 [4] - Gedatolisib is a potent pan-PI3K and mTORC1/2 inhibitor, differentiating its mechanism of action from other therapies targeting PI3Kα, AKT, or mTORC1 [4] - The company is conducting multiple clinical trials, including the ongoing Phase 1/2 trial for metastatic castration-resistant prostate cancer and the Phase 3 VIKTORIA-2 trial for first-line treatment in HR+/HER2- ABC [4]
Celcuity(CELC) - 2025 Q2 - Earnings Call Transcript
2025-08-14 21:30
Financial Data and Key Metrics Changes - The company reported a net loss of $45.3 million or $1.04 per share for Q2 2025, compared to a net loss of $23.7 million or $0.62 per share for Q2 2024, indicating a significant increase in losses [26] - Non-GAAP adjusted net loss was $40.5 million or $0.93 per share for Q2 2025, compared to a non-GAAP adjusted net loss of $22.2 million or $0.58 per share for Q2 2024 [26] - Research and development expenses increased to $40.2 million for Q2 2025 from $22.5 million in Q2 2024, driven by increased employee and consulting expenses and costs related to ongoing clinical trials [26][27] - General and administrative expenses rose to $3.8 million for Q2 2025 from $1.8 million in Q2 2024, primarily due to increased employee and consulting expenses [27] - The company ended the quarter with approximately $168.4 million in cash, cash equivalents, and short-term investments, which is expected to increase to approximately $455 million after accounting for recent financing activities [28] Business Line Data and Key Metrics Changes - The company achieved significant milestones in its clinical trials, including positive top-line data from the VICTORIA-one trial for patients with HR positive HER2 negative advanced breast cancer, demonstrating unprecedented improvements in progression-free survival (PFS) [6][10] - The median PFS for the gadatholitinib triplet was reported at 9.3 months compared to 2 months for fulvestrant, with a hazard ratio of 0.24, indicating a 4.2 times higher likelihood of survival without disease progression [10][11] - The company also dosed the first patient in the VICTORIA-two trial, which evaluates gadatholitinib in combination with a CDK4/6 inhibitor and fulvestrant as first-line treatment [8][18] Market Data and Key Metrics Changes - The addressable market potential for a standard of care second-line therapy for the targeted patient population is estimated at approximately $5 billion [18] - There are approximately 34,000 patients moving to second-line treatment after progressing on a CDK4/6 inhibitor, with around 60% being PIK3CA wild type, indicating a large opportunity for the company's therapies [14] Company Strategy and Development Direction - The company aims to establish gadatholitinib as a new standard of care therapy for patients with HR positive HER2 negative advanced breast cancer, focusing on both PIK3CA wild type and mutated populations [6][10] - The company plans to submit a new drug application to the FDA in 2025 based on data from the PIK3CA wild type cohort [13] - The company is preparing for a potential launch of gadatholitinib, having built a commercial team and infrastructure to support the launch [48][52] Management's Comments on Operating Environment and Future Outlook - Management expressed optimism about the market landscape for gadatholitinib, highlighting the significant unmet need for more efficacious therapies in the second-line treatment space [14][15] - The company believes that the favorable safety profile and efficacy of gadatholitinib will position it well against currently available therapies [12][15] - Management is confident in the robustness of the data and the preparations for the NDA submission, indicating a strong belief in the potential approval and market entry [70] Other Important Information - The company raised approximately $287 million through public offerings of convertible notes, common stock, and pre-funded warrants, providing necessary funding for its operations and clinical trials [10][24] - A new patent was issued extending the exclusivity of gadatholitinib into 2042, allowing the company to optimize its development strategy [23][24] Q&A Session Summary Question: What to expect from the upcoming full data presentation for the PIK3CA wild type portion of the Phase III study? - The company will focus on primary analyses and endpoints, with additional subgroup analyses expected at subsequent meetings [30][31] Question: What benchmarks for success are considered for the PIK3CA mutant population? - A statistically significant result would be clinically meaningful if it shows an improvement of less than three months compared to historical data [32] Question: Can more safety data be provided ahead of the full presentation? - Detailed safety data will be provided at the upcoming conference, with a general summary available at this stage [37] Question: Will PFS analysis based on investigator assessment be presented later this year? - The selection of BICR for the study was to eliminate investigator bias, and the investigator data will be used for exploratory analysis [40][42] Question: How is the company preparing for launch readiness? - The company has been building its team and infrastructure since last year, focusing on key positions to support the launch [48][52] Question: What are the practical ramifications for physicians with both doublet and triplet options? - Having both regimens allows physicians to optimize treatment based on patient needs, providing flexibility in managing disease progression [55][56] Question: Is there a consideration for a commercial partnering strategy for the launch? - The company plans to launch itself, believing it has the necessary infrastructure and capital to do so effectively [58][59] Question: What are the competitive landscape thoughts regarding the mutant population? - The company believes that positive data will position it well against competitors, particularly in the context of PIK3CA mutations [65][66]
Celcuity(CELC) - 2025 Q2 - Quarterly Report
2025-08-14 21:01
[PART I. FINANCIAL INFORMATION](index=3&type=section&id=PART%20I.%20FINANCIAL%20INFORMATION) [ITEM 1. Financial Statements (unaudited)](index=3&type=section&id=ITEM%201.%20Financial%20Statements%20(unaudited)) This section presents the company's unaudited condensed financial statements for the periods ended June 30, 2025, and December 31, 2024 [Condensed Balance Sheets](index=4&type=section&id=Condensed%20Balance%20Sheets%20as%20of%20June%2030%2C%202025%20and%20December%2031%2C%202024) Condensed Balance Sheets | Metric (in thousands) | June 30, 2025 | December 31, 2024 | Change ($) | Change (%) | | :-------------------- | :------------ | :---------------- | :--------- | :--------- | | Cash and cash equivalents | $46,354 | $22,515 | $23,839 | 105.9% | | Investments | $122,032 | $212,589 | $(90,557) | -42.6% | | Total current assets | $183,104 | $244,571 | $(61,467) | -25.1% | | Total Assets | $183,592 | $245,123 | $(61,531) | -25.1% | | Total current liabilities | $39,941 | $31,723 | $8,218 | 25.9% | | Total Liabilities | $139,217 | $129,504 | $9,713 | 7.5% | | Total Stockholders' Equity | $44,375 | $115,619 | $(71,244) | -61.6% | [Condensed Statements of Operations](index=5&type=section&id=Condensed%20Statements%20of%20Operations%20for%20the%20three%20months%20and%20six%20months%20ended%20June%2030%2C%202025%20and%202024) For the Three Months Ended June 30 | Metric (in thousands) | 3 Months Ended June 30, 2025 | 3 Months Ended June 30, 2024 | Change ($) | Change (%) | | :-------------------- | :--------------------------- | :--------------------------- | :--------- | :--------- | | Research and development | $40,222 | $22,498 | $17,724 | 78.8% | | General and administrative | $3,787 | $1,786 | $2,001 | 112.0% | | Total operating expenses | $44,009 | $24,284 | $19,725 | 81.2% | | Loss from operations | $(44,009) | $(24,284) | $(19,725) | 81.2% | | Interest expense | $(3,204) | $(2,260) | $(944) | 41.8% | | Interest income | $1,945 | $2,822 | $(877) | -31.1% | | Net loss | $(45,268) | $(23,722) | $(21,546) | 90.8% | | Net loss per share, basic and diluted | $(1.04) | $(0.62) | $(0.42) | 67.7% | For the Six Months Ended June 30 | Metric (in thousands) | 6 Months Ended June 30, 2025 | 6 Months Ended June 30, 2024 | Change ($) | Change (%) | | :-------------------- | :--------------------------- | :--------------------------- | :--------- | :--------- | | Research and development | $72,449 | $43,145 | $29,304 | 67.9% | | General and administrative | $7,693 | $3,632 | $4,061 | 111.8% | | Total operating expenses | $80,142 | $46,777 | $33,365 | 71.3% | | Loss from operations | $(80,142) | $(46,777) | $(33,365) | 71.3% | | Interest expense | $(6,387) | $(3,661) | $(2,726) | 74.5% | | Interest income | $4,264 | $5,104 | $(840) | -16.5% | | Net loss | $(82,265) | $(45,334) | $(36,931) | 81.5% | | Net loss per share, basic and diluted | $(1.90) | $(1.26) | $(0.64) | 50.8% | [Condensed Statements of Stockholders' Equity (2025)](index=6&type=section&id=Condensed%20Statements%20of%20Stockholders'%20Equity%20for%20the%20three%20months%20and%20six%20months%20ended%20June%2030%2C%202025) - Total Stockholders' Equity **decreased from $115,619 thousand to $44,375 thousand** at June 30, 2025, primarily due to a **net loss of $82,265 thousand**[16](index=16&type=chunk) Changes in Stockholders' Equity (Six Months Ended June 30, 2025) | Activity (in thousands) | Six Months Ended June 30, 2025 | | :---------------------- | :----------------------------- | | Balance at Dec 31, 2024 | $115,619 | | Stock-based compensation | $5,148 | | Exercise of common stock warrants | $5,600 | | Exercise of common stock options | $20 | | Employee stock purchases | $253 | | Conversion of preferred stock to common stock | $0 | | Net loss | $(82,265) | | Balance at June 30, 2025 | $44,375 | [Condensed Statements of Stockholders' Equity (2024)](index=7&type=section&id=Condensed%20Statements%20of%20Stockholders'%20Equity%20for%20the%20three%20months%20and%20six%20months%20ended%20June%2030%2C%202024) - Total Stockholders' Equity **increased to $176,685 thousand** at June 30, 2024, driven by proceeds from common stock offerings and warrant exercises, despite a net loss[19](index=19&type=chunk) Changes in Stockholders' Equity (Six Months Ended June 30, 2024) | Activity (in thousands) | Six Months Ended June 30, 2024 | | :---------------------- | :----------------------------- | | Balance at Dec 31, 2023 | $139,770 | | Stock-based compensation | $2,742 | | Exercise of common stock warrants | $14,182 | | Exercise of common stock options | $335 | | Employee stock purchases | $131 | | Conversion of preferred to common stock | $0 | | Issuance of common stock in an ATM offering | $7,642 | | Issuance of common stock upon closing of follow-on offering | $56,252 | | Issuance of common stock warrants, note payable | $1,229 | | Net loss | $(45,334) | | Balance at June 30, 2024 | $176,685 | [Condensed Statements of Cash Flows](index=8&type=section&id=Condensed%20Statements%20of%20Cash%20Flows%20for%20the%20six%20months%20ended%20June%2030%2C%202025%20and%202024) Cash Flow Summary | Cash Flow Activity (in thousands) | Six Months Ended June 30, 2025 | Six Months Ended June 30, 2024 | Change ($) | Change (%) | | :-------------------------------- | :----------------------------- | :----------------------------- | :--------- | :--------- | | Net cash used in operating activities | $(72,065) | $(35,135) | $(36,930) | 105.1% | | Net cash provided by (used in) investing activities | $90,118 | $(102,531) | $192,649 | -187.9% | | Net cash provided by financing activities | $5,786 | $137,462 | $(131,676) | -95.8% | | Net change in cash and cash equivalents | $23,839 | $(204) | $24,043 | -11785.8% | [Notes to Unaudited Condensed Financial Statements](index=9&type=section&id=Notes%20to%20Unaudited%20Condensed%20Financial%20Statements) [1. Organization](index=9&type=section&id=1.%20Organization) - Celcuity Inc is a clinical-stage biotechnology company focused on developing targeted therapies for solid tumors, with **gedatolisib** as its lead therapeutic candidate[24](index=24&type=chunk) - Gedatolisib is a kinase inhibitor targeting the **PI3K/AKT/mTOR (PAM) pathway**, designed for comprehensive inhibition of all Class I PI3K isoforms and mTORC1/2[24](index=24&type=chunk) - Key clinical trials include Phase 3 **VIKTORIA-1**, Phase 3 **VIKTORIA-2**, and Phase 1b/2 **CELC-G-201**[24](index=24&type=chunk) [2. Basis of Presentation, Summary of Significant Accounting Policies and Recent Accounting Pronouncements](index=9&type=section&id=2.%20Basis%20of%20Presentation%2C%20Summary%20of%20Significant%20Accounting%20Policies%20and%20Recent%20Accounting%20Pronouncements) - The unaudited condensed financial statements are prepared in accordance with SEC regulations and U.S GAAP, relying on management estimates[25](index=25&type=chunk)[26](index=26&type=chunk) - The company faces risks common to development-stage biotech companies, including clinical success, regulatory approval, and the need for additional financing[27](index=27&type=chunk) - Clinical trial costs are estimated based on third-party progress reports, with potential for material changes in estimates affecting financial results[29](index=29&type=chunk) [3. Net Loss Per Common Share](index=10&type=section&id=3.%20Net%20Loss%20Per%20Common%20Share) - Basic and diluted net loss per common share are identical because potential common shares were **anti-dilutive** for all periods presented[30](index=30&type=chunk) Anti-Dilutive Securities | Potential Common Shares (in thousands) | June 30, 2025 | June 30, 2024 | | :------------------------------------- | :------------ | :------------ | | Preferred stock (as-if-converted) | 2,131,510 | 3,175,770 | | Options to purchase common stock | 5,075,566 | 3,266,969 | | Warrants to purchase common stock | 4,825,502 | 5,600,234 | | Restricted common stock | 1,029 | 1,079 | | Total anti-dilutive shares | 12,033,607 | 12,044,052 | [4. Investments](index=10&type=section&id=4.%20Investments) - The Company's investments are classified as **held-to-maturity debt securities**, primarily U.S Treasury Bills, reported at amortized cost[32](index=32&type=chunk)[34](index=34&type=chunk) - **No credit losses are expected** on these securities, as they are guaranteed by the U.S government[32](index=32&type=chunk) Investment Portfolio | Investment (in thousands) | Amortized Cost (June 30, 2025) | Estimated Fair Value (June 30, 2025) | Amortized Cost (Dec 31, 2024) | Estimated Fair Value (Dec 31, 2024) | | :------------------------ | :----------------------------- | :----------------------------------- | :---------------------------- | :---------------------------------- | | U.S. Treasury Bills | $122,032 | $122,021 | $212,589 | $212,671 | [5. Commitments](index=11&type=section&id=5.%20Commitments) - The Company leases its corporate space through April 2026, with rent expense recorded on a straight-line basis[35](index=35&type=chunk) - Clinical research study contracts are generally cancelable with notice, and obligations are based on services performed[36](index=36&type=chunk) - As of June 30, 2025, the Company had approximately **$3.6 million in material non-cancelable contractual commitments**[36](index=36&type=chunk) [6. Stockholders' Equity](index=11&type=section&id=6.%20Stockholders'%20Equity) - As of June 30, 2025, the Company had **38,914,208 shares of common stock** and **213,151 shares of preferred stock** outstanding[40](index=40&type=chunk) - In March 2025, an investor exercised 695,650 warrants, generating approximately **$5.6 million in cash**[38](index=38&type=chunk) - In June 2025, 104,426 shares of preferred stock were converted into **1,044,260 shares of common stock**[40](index=40&type=chunk) [7. Stock-Based Compensation](index=13&type=section&id=7.%20Stock-Based%20Compensation) - The 2017 Stock Incentive Plan's reserved shares automatically increased by 371,432 on January 1, 2025, and stockholders approved an additional **3,000,000 share increase** in May 2025[42](index=42&type=chunk)[43](index=43&type=chunk) - Total unrecognized compensation cost related to stock options and RSAs is estimated at **$22.491 million** as of June 30, 2025, to be recognized through 2029[52](index=52&type=chunk) Stock-Based Compensation Expense | Expense Category (in thousands) | 3 Months Ended June 30, 2025 | 3 Months Ended June 30, 2024 | 6 Months Ended June 30, 2025 | 6 Months Ended June 30, 2024 | | :------------------------------ | :--------------------------- | :--------------------------- | :--------------------------- | :--------------------------- | | Research and development | $1,722 | $978 | $3,227 | $1,810 | | General and administrative | $982 | $433 | $1,921 | $932 | | Total Stock-based compensation | $2,704 | $1,411 | $5,148 | $2,742 | [8. Debt](index=15&type=section&id=8.%20Debt) - On May 30, 2024, the Company entered into an Amended and Restated Loan and Security Agreement for up to **$180 million in Term Loans**, with **$100 million initially funded**[54](index=54&type=chunk)[55](index=55&type=chunk) - The Term Loans mature on May 1, 2029, bear interest at Prime Rate plus 2.85%, and are secured by all Company assets[56](index=56&type=chunk) - The A&R Loan Agreement includes a **$4.5 million Final Fee**, contingent non-utilization fees, and warrants issued to lenders[58](index=58&type=chunk)[59](index=59&type=chunk) Long-term Debt Summary | Long-term Debt (in thousands) | June 30, 2025 | December 31, 2024 | | :---------------------------- | :------------ | :---------------- | | Note payable | $100,000 | $100,000 | | Add: Final fee | $4,500 | $4,500 | | Add: PIK interest | $1,093 | $593 | | Less: unamortized debt issuance costs | $(1,202) | $(1,614) | | Less: unamortized debt discount | $(5,115) | $(5,752) | | Total long-term debt | $99,276 | $97,727 | [9. License Agreement](index=17&type=section&id=9.%20License%20Agreement) - On April 8, 2021, the Company licensed exclusive global rights for gedatolisib from Pfizer, involving an upfront fee of **$5.0 million** and **$5.0 million in common stock**[64](index=64&type=chunk) - The agreement includes potential milestone payments up to **$335.0 million**, with a **$5.0 million payment now probable** upon FDA New Drug Application filing[65](index=65&type=chunk) - Tiered royalties on gedatolisib sales, ranging from **low to mid-teens**, are also payable to Pfizer[65](index=65&type=chunk) [10. Subsequent Events](index=17&type=section&id=10.%20Subsequent%20Events) - On July 28, 2025, the A&R Loan Agreement was amended to permit convertible notes issuance and capped call transactions[67](index=67&type=chunk) - The Company achieved the Term D Milestone and plans to draw an additional **$30.0 million** under the Term D Loan in late August 2025[69](index=69&type=chunk) - In July 2025, the Company completed an Equity Offering and a Convertible Notes Offering, raising approximately **$91.6 million** and **$194.9 million** net, respectively[71](index=71&type=chunk)[73](index=73&type=chunk) - In July and August 2025, investors exercised warrants, generating approximately **$10.4 million** and **$1.6 million** in cash, respectively[80](index=80&type=chunk) [ITEM 2. Management's Discussion and Analysis of Financial Condition and Results of Operations](index=20&type=section&id=ITEM%202.%20Management's%20Discussion%20and%20Analysis%20of%20Financial%20Condition%20and%20Results%20of%20Operations) Management discusses financial condition, operational results, clinical developments, and liquidity for the recent period [Overview](index=20&type=section&id=Overview) - Celcuity is a clinical-stage biotechnology company developing targeted therapies for solid tumors, with **gedatolisib** as its lead candidate[82](index=82&type=chunk)[84](index=84&type=chunk) - Gedatolisib's intravenous administration offers a **better-tolerated safety profile** compared to oral PI3K and mTOR drugs[85](index=85&type=chunk)[86](index=86&type=chunk) - The company is conducting multiple clinical trials: Phase 3 **VIKTORIA-1**, Phase 3 **VIKTORIA-2**, and Phase 1b/2 **CELC-G-201**[82](index=82&type=chunk)[92](index=92&type=chunk)[94](index=94&type=chunk)[99](index=99&type=chunk) - The B2151009 Phase 1b trial showed high **objective overall response rates (ORR) of 63%** and a median **progression-free survival (PFS) of 48.6 months** for treatment-naïve patients[89](index=89&type=chunk)[90](index=90&type=chunk)[91](index=91&type=chunk) [Recent Developments](index=23&type=section&id=Recent%20Developments) - A new U.S patent was issued on July 8, 2025, covering gedatolisib's clinical dosing regimen, extending exclusivity into **August 2042**[102](index=102&type=chunk) - Topline data from the VIKTORIA-1 trial showed **statistically significant and clinically meaningful improvements in PFS** for both gedatolisib regimens[104](index=104&type=chunk) - Both gedatolisib regimens in VIKTORIA-1 demonstrated **lower rates of hyperglycemia and stomatitis** and lower discontinuation rates[105](index=105&type=chunk) - The Company expects to submit a **New Drug Application (NDA)** for gedatolisib to the FDA in the **fourth quarter of 2025**[106](index=106&type=chunk) - In July 2025, the Company completed an Equity Offering and a Convertible Notes Offering, raising approximately **$91.6 million** and **$194.9 million** net, respectively[108](index=108&type=chunk)[109](index=109&type=chunk) [Results of Operations](index=24&type=section&id=Results%20of%20Operations) - The Company has not generated any revenue and incurred a **net loss of $82.3 million** for the six months ended June 30, 2025, with an accumulated deficit of **$354.1 million**[110](index=110&type=chunk) - The increase in R&D expenses was driven by increased employee/consulting expenses, clinical trial activities, and a **$5.0 million anticipated milestone payment** to Pfizer[121](index=121&type=chunk)[122](index=122&type=chunk) - Interest expense increased by **74%** for the six months ended June 30, 2025, due to incremental funding of Term Loan C in May 2024[126](index=126&type=chunk)[127](index=127&type=chunk) - Interest income decreased by **16%** for the six months ended June 30, 2025, due to lower market interest rates and reduced average cash balances[128](index=128&type=chunk)[129](index=129&type=chunk) Operating Expenses (Three Months) | Operating Expense (in thousands) | 3 Months Ended June 30, 2025 | 3 Months Ended June 30, 2024 | Change ($) | Change (%) | | :------------------------------- | :--------------------------- | :--------------------------- | :--------- | :--------- | | Research and development | $40,222 | $22,498 | $17,724 | 79% | | General and administrative | $3,787 | $1,786 | $2,001 | 112% | | Total operating expenses | $44,009 | $24,284 | $19,725 | 81% | Operating Expenses (Six Months) | Operating Expense (in thousands) | 6 Months Ended June 30, 2025 | 6 Months Ended June 30, 2024 | Change ($) | Change (%) | | :------------------------------- | :--------------------------- | :--------------------------- | :--------- | :--------- | | Research and development | $72,449 | $43,145 | $29,304 | 68% | | General and administrative | $7,693 | $3,632 | $4,061 | 112% | | Total operating expenses | $80,142 | $46,777 | $33,365 | 71% | [Liquidity and Capital Resources](index=28&type=section&id=Liquidity%20and%20Capital%20Resources) - As of June 30, 2025, the Company had **$46.4 million in cash** and cash equivalents and **$122.0 million in short-term investments**[130](index=130&type=chunk) - Since inception, the Company has raised approximately **$478.7 million from equity sales**, **$194.9 million from convertible notes**, and **$100.0 million from loan agreements**[131](index=131&type=chunk) - Recent financing activities include a July 2025 Equity Offering (**$91.6 million net**) and a July 2025 Convertible Notes Offering (**$194.9 million net**)[133](index=133&type=chunk)[135](index=135&type=chunk) - The A&R Loan Agreement provides for up to **$180 million in Term Loans**, with eligibility to draw an additional **$30 million** (Term D) and **$50 million** (Term E)[145](index=145&type=chunk)[146](index=146&type=chunk) - Management believes current cash, investments, and available borrowings will **fund operations through 2027**[154](index=154&type=chunk)[155](index=155&type=chunk) [Cash Flows](index=33&type=section&id=Cash%20Flows) - **Operating cash outflow increased significantly** in 2025 due to higher net loss[157](index=157&type=chunk) - Investing activities shifted from net cash used in 2024 to **net cash provided in 2025** from maturities of investments[158](index=158&type=chunk)[159](index=159&type=chunk) - **Financing cash inflow decreased substantially** in 2025 compared to 2024, which included significant proceeds from an equity offering and debt financing[160](index=160&type=chunk)[161](index=161&type=chunk) Cash Flow Summary (Six Months) | Cash Flow Activity (in thousands) | Six Months Ended June 30, 2025 | Six Months Ended June 30, 2024 | | :-------------------------------- | :----------------------------- | :----------------------------- | | Net cash used in operating activities | $(72,065) | $(35,135) | | Net cash provided by (used in) investing activities | $90,118 | $(102,531) | | Net cash provided by financing activities | $5,786 | $137,462 | | Net increase (decrease) in cash and cash equivalents | $23,839 | $(204) | [Recent Accounting Pronouncements](index=33&type=section&id=Recent%20Accounting%20Pronouncements) - The Company believes that recently issued accounting standards not yet effective will **not have a material impact** on its financial position or results of operations[162](index=162&type=chunk) [Critical Accounting Policies and Use of Estimates](index=34&type=section&id=Critical%20Accounting%20Policies%20and%20Use%20of%20Estimates) - The preparation of financial statements requires management to make estimates and assumptions that affect reported amounts, with actual results potentially differing materially[163](index=163&type=chunk) [Private Securities Litigation Reform Act](index=34&type=section&id=Private%20Securities%20Litigation%20Reform%20Act) - This section serves as a 'safe harbor' for forward-looking statements, which involve risks and uncertainties that may cause actual results to differ materially[165](index=165&type=chunk)[167](index=167&type=chunk) - Forward-looking statements are identified by words like 'anticipate,' 'believe,' 'expect,' and 'plan,' and are based on management's beliefs and assumptions[166](index=166&type=chunk) - Key risks include limited operating history, regulatory approval, clinical study uncertainties, market acceptance, and intellectual property protection[167](index=167&type=chunk) [ITEM 3. Quantitative and Qualitative Disclosures About Market Risk](index=35&type=section&id=ITEM%203.%20Quantitative%20and%20Qualitative%20Disclosures%20About%20Market%20Risk) The company is exempt from market risk disclosures as a smaller reporting company - The Company is exempt from providing quantitative and qualitative disclosures about market risk due to its status as a **smaller reporting company**[169](index=169&type=chunk) [ITEM 4. Controls and Procedures](index=35&type=section&id=ITEM%204.%20Controls%20and%20Procedures) Management confirms the effectiveness of disclosure controls and procedures as of the period end - The Certifying Officers concluded that the Company's disclosure controls and procedures were **effective as of June 30, 2025**[170](index=170&type=chunk) - There were **no material changes** in the Company's internal control over financial reporting during the three months ended June 30, 2025[171](index=171&type=chunk) [PART II. OTHER INFORMATION](index=36&type=section&id=PART%20II.%20OTHER%20INFORMATION) [ITEM 1. Legal Proceedings](index=36&type=section&id=ITEM%201.%20Legal%20Proceedings) The company reports no material legal proceedings - The Company is not a party to any legal proceedings that could reasonably be expected to have a **material adverse effect** on its business[172](index=172&type=chunk) [ITEM 1A. Risk Factors](index=36&type=section&id=ITEM%201A.%20Risk%20Factors) Updates on material risks including trade policy, regulatory disruptions, and company indebtedness - Changes in U.S or international **trade policies** could materially and adversely affect the Company's business and financial condition[174](index=174&type=chunk)[175](index=175&type=chunk)[176](index=176&type=chunk) - **Disruptions at the FDA** and other government agencies could hinder the Company's ability to obtain timely approval for product candidates[177](index=177&type=chunk)[178](index=178&type=chunk)[179](index=179&type=chunk)[180](index=180&type=chunk) - The Company's **indebtedness**, including **$100.0 million in Term Loans** and **$201.25 million in Convertible Senior Notes**, could limit cash flow and expose it to adverse risks[181](index=181&type=chunk)[183](index=183&type=chunk) - The Company may be **unable to raise sufficient funds** to repurchase the Notes following a fundamental change or to pay cash amounts due upon maturity[184](index=184&type=chunk) [ITEM 2. Unregistered Sales of Equity Securities and Use of Proceeds](index=38&type=section&id=ITEM%202.%20Unregistered%20Sales%20of%20Equity%20Securities%20and%20Use%20of%20Proceeds) The company reports no unregistered sales or issuer purchases of equity securities during the period - There were **no unregistered sales** of equity securities during the period[186](index=186&type=chunk) - There were **no issuer purchases** of equity securities during the period[187](index=187&type=chunk) [ITEM 3. Defaults Upon Senior Securities](index=38&type=section&id=ITEM%203.%20Defaults%20Upon%20Senior%20Securities) The company reports no defaults upon senior securities - There were **no defaults** upon senior securities during the period[188](index=188&type=chunk) [ITEM 4. Mine Safety Disclosures](index=38&type=section&id=ITEM%204.%20Mine%20Safety%20Disclosures) The company has no mine safety disclosures to report - There are **no mine safety disclosures** to report[189](index=189&type=chunk) [ITEM 5. Other Information](index=38&type=section&id=ITEM%205.%20Other%20Information) Discloses a 10b5-1 trading plan adopted by Brightstone for the sale of up to 229,335 shares of company common stock - On June 13, 2025, Brightstone adopted a **10b5-1 plan** to sell up to **229,335 shares** of Celcuity Inc common stock[190](index=190&type=chunk) - No other directors or officers adopted or terminated Rule 10b5-1 or non-Rule 10b5-1 trading arrangements during the quarter[191](index=191&type=chunk) [ITEM 6. Exhibits](index=39&type=section&id=ITEM%206.%20Exhibits) This section lists all exhibits filed with the Quarterly Report on Form 10-Q - Exhibits include the Certificate of Incorporation, Bylaws, Loan Agreements, Stock Incentive Plan, Certifications, and Inline XBRL data[193](index=193&type=chunk) [Signatures](index=40&type=section&id=Signatures) - The report is duly signed on August 14, 2025, by Brian F Sullivan, Chairman and Chief Executive Officer, and Vicky Hahne, Chief Financial Officer[197](index=197&type=chunk)[198](index=198&type=chunk)
Celcuity(CELC) - 2025 Q2 - Quarterly Results
2025-08-14 20:07
[Celcuity Inc. Q2 2025 Earnings Release](index=1&type=section&id=Celcuity%20Inc.%20Q2%202025%20Earnings%20Release) [Corporate Update and Business Highlights](index=1&type=section&id=Corporate%20Update%20and%20Business%20Highlights) Celcuity reported positive Phase 3 VIKTORIA-1 data for gedatolisib, plans Q4 2025 NDA, and secured **$286.5 million** in financing - Announced **positive topline data** from the PIK3CA wild-type cohort of the Phase 3 VIKTORIA-1 trial, showing **unprecedented reduction** in risk of disease progression or death[3](index=3&type=chunk)[4](index=4&type=chunk) - Plans to submit a **New Drug Application (NDA)** for gedatolisib to the FDA in the **fourth quarter of 2025**, based on data from the PIK3CA wild-type cohort[3](index=3&type=chunk)[4](index=4&type=chunk)[7](index=7&type=chunk) - Completed concurrent offerings of convertible notes, common stock, and warrants, raising net proceeds of **$286.5 million**[4](index=4&type=chunk)[7](index=7&type=chunk) - A new patent was issued for gedatolisib's dosing regimen, extending U.S. **patent exclusivity into 2042**[4](index=4&type=chunk)[7](index=7&type=chunk) [Clinical Trial Updates (Gedatolisib)](index=1&type=section&id=Clinical%20Trial%20Updates%20(Gedatolisib)) Gedatolisib showed significant risk reduction in VIKTORIA-1's PIK3CA wild-type cohort, with other trials progressing VIKTORIA-1 PIK3CA Wild-Type Cohort Efficacy | Regimen | Hazard Ratio (HR) vs Fulvestrant | Risk Reduction | Median PFS (months) | Incremental PFS Improvement (months) | | :--- | :--- | :--- | :--- | :--- | | Gedatolisib Triplet | 0.24 | 76% | 9.3 | 7.3 | | Gedatolisib Doublet | 0.33 | 67% | 7.4 | 5.4 | - Enrollment is ongoing in the PIK3CA mutant cohort of the VIKTORIA-1 trial, with **topline data anticipated by the end of 2025**[4](index=4&type=chunk)[7](index=7&type=chunk) - The **first patient was dosed** in the **Phase 3 VIKTORIA-2 trial**, evaluating gedatolisib as a first-line treatment for HR+/HER2- ABC[4](index=4&type=chunk)[7](index=7&type=chunk) - **Positive topline data** from the Phase 1b CELC-G-201 study in metastatic castration resistant prostate cancer (mCRPC) showed a **six-month radiographic progression-free survival rate of 66%**[7](index=7&type=chunk) [Corporate and Financial Strength](index=1&type=section&id=Corporate%20and%20Financial%20Strength) Celcuity significantly strengthened its financial position, raising **$286.5 million** and securing **$455 million** proforma cash - Completed concurrent offerings of convertible notes, common stock, and pre-funded warrants with net proceeds of **$286.5 million**[4](index=4&type=chunk)[7](index=7&type=chunk) - Proforma cash, cash equivalents, and short-term investments totaled **$455 million** as of June 30, 2025, which is expected to **fund operations through 2027**[4](index=4&type=chunk)[13](index=13&type=chunk) [Q2 2025 Financial Results](index=2&type=section&id=Q2%202025%20Financial%20Results) Celcuity's Q2 2025 operating expenses increased to **$44.0 million**, leading to a **$45.3 million** GAAP net loss due to higher R&D Q2 2025 Financial Summary (vs. Q2 2024) | Metric | Q2 2025 | Q2 2024 | | :--- | :--- | :--- | | Total Operating Expenses | $44.0 million | $24.3 million | | R&D Expenses | $40.2 million | $22.5 million | | G&A Expenses | $3.8 million | $1.8 million | | GAAP Net Loss | $45.3 million | $23.7 million | | GAAP Net Loss Per Share | $1.04 | $0.62 | | Non-GAAP Adjusted Net Loss | $40.5 million | $22.2 million | | Non-GAAP Adj. Net Loss/Share | $0.93 | $0.58 | [Statement of Operations Analysis](index=3&type=section&id=Statement%20of%20Operations%20Analysis) Q2 2025 R&D expenses increased by **$17.7 million** due to employee, clinical trial, and milestone costs, while G&A rose by **$2.0 million** - R&D expenses increased by **$17.7 million**, primarily due to a **$5.0 million** anticipated development milestone payment, **$6.6 million** in employee/consulting expenses, and **$6.1 million** in costs for ongoing clinical trials[9](index=9&type=chunk) - G&A expenses increased by approximately **$2.0 million**, with **$1.6 million** related to higher employee and consulting costs[10](index=10&type=chunk) [Balance Sheet and Cash Flow](index=3&type=section&id=Balance%20Sheet%20and%20Cash%20Flow) Celcuity reported **$168.4 million** in cash and equivalents as of June 30, 2025, with net cash used in operations at **$36.2 million** for Q2 - Cash, cash equivalents, and short-term investments stood at **$168.4 million** as of June 30, 2025[13](index=13&type=chunk) - Net cash used in operating activities for Q2 2025 was **$36.2 million**, compared to **$18.1 million** for Q2 2024[12](index=12&type=chunk) [Financial Statements](index=5&type=section&id=Financial%20Statements) This section presents Celcuity's unaudited Q2 2025 financial statements, including balance sheet, statement of operations, and GAAP to non-GAAP reconciliation [Condensed Balance Sheets](index=5&type=section&id=Condensed%20Balance%20Sheets) The condensed balance sheet shows total assets of **$183.6 million** and total liabilities of **$139.2 million** as of June 30, 2025 Condensed Balance Sheet Data (in thousands) | Account | June 30, 2025 (unaudited) | December 31, 2024 | | :--- | :--- | :--- | | Cash and cash equivalents | $46,354 | $22,515 | | Investments | $122,032 | $212,589 | | **Total Current Assets** | **$183,104** | **$244,571** | | **Total Assets** | **$183,592** | **$245,123** | | Total Current Liabilities | $39,941 | $31,723 | | **Total Liabilities** | **$139,217** | **$129,504** | | **Total Stockholders' Equity** | **$44,375** | **$115,619** | [Condensed Statements of Operations](index=6&type=section&id=Condensed%20Statements%20of%20Operations) For Q2 2025, Celcuity reported total operating expenses of **$44.0 million** and a net loss of **$45.3 million** Condensed Statement of Operations (in thousands, except per share data) | Metric | Three Months Ended June 30, 2025 | Three Months Ended June 30, 2024 | | :--- | :--- | :--- | | Research and development | $40,222 | $22,498 | | General and administrative | $3,787 | $1,786 | | **Total operating expenses** | **$44,009** | **$24,284** | | Loss from operations | $(44,009) | $(24,284) | | **Net loss** | **$(45,268)** | **$(23,722)** | | Net loss per share | $(1.04) | $(0.62) | [Reconciliation of GAAP to Non-GAAP Measures](index=7&type=section&id=Reconciliation%20of%20GAAP%20to%20Non-GAAP%20Measures) This section reconciles GAAP net loss to non-GAAP adjusted net loss, with Q2 2025 GAAP net loss of **$45.3 million** adjusted to **$40.5 million** non-GAAP - Management uses **non-GAAP measures** to exclude items like stock-based compensation and non-cash interest, believing it better enables a focus on **cash used in operations**[23](index=23&type=chunk) GAAP to Non-GAAP Reconciliation for Q2 2025 (in thousands) | Description | Amount | | :--- | :--- | | **GAAP net loss** | **$(45,268)** | | Stock-based compensation (R&D) | $1,722 | | Stock-based compensation (G&A) | $982 | | Non-cash interest expense | $789 | | Non-cash interest income | $1,286 | | **Non-GAAP adjusted net loss** | **$(40,489)** |
Celcuity Inc. Reports Second Quarter 2025 Financial Results and Provides Corporate Update
GlobeNewswire News Room· 2025-08-14 20:01
Core Insights - Celcuity Inc. reported significant advancements in its clinical trials, particularly the Phase 3 VIKTORIA-1 trial, which demonstrated a substantial reduction in disease progression risk for patients with HR+/HER2- advanced breast cancer [2][4][5] - The company plans to submit a New Drug Application (NDA) for its lead candidate, gedatolisib, to the FDA in the fourth quarter of 2025, based on promising data from the PIK3CA wild-type cohort [2][4][5] - Financial results for Q2 2025 showed a net loss of $45.3 million, an increase from $23.7 million in Q2 2024, with total operating expenses rising to $44.0 million [6][9][19] Business Developments - Positive topline data from the PIK3CA wild-type cohort indicated a 76% reduction in the risk of disease progression or death with the gedatolisib triplet therapy compared to fulvestrant [5] - The company has initiated enrollment in the PIK3CA mutant cohort of the VIKTORIA-1 trial, with topline data expected by the end of 2025 [4][5] - A new patent for gedatolisib's dosing regimen was issued, extending exclusivity until 2042 [12] Financial Performance - Total operating expenses for Q2 2025 were $44.0 million, up from $24.3 million in Q2 2024, with R&D expenses accounting for $40.2 million [6][7][19] - The net cash used in operating activities increased to $36.2 million in Q2 2025 from $18.1 million in Q2 2024 [10] - As of June 30, 2025, the company reported cash, cash equivalents, and short-term investments totaling $168.4 million, which, after recent financing, is projected to support operations through 2027 [11][12]
Celcuity Inc. Schedules Release of Second Quarter 2025 Financial Results and Webcast/Conference Call
Globenewswire· 2025-08-07 11:05
Company Overview - Celcuity Inc. is a clinical-stage biotechnology company focused on developing targeted therapies for oncology, specifically for multiple solid tumor indications [3] - The company's lead therapeutic candidate is gedatolisib, a potent pan-PI3K and mTORC1/2 inhibitor that blocks the PAM pathway comprehensively [3] - Celcuity is headquartered in Minneapolis and provides further information on its website [3] Clinical Trials - A Phase 3 clinical trial, VIKTORIA-1, is currently enrolling patients to evaluate gedatolisib in combination with fulvestrant with or without palbociclib for HR+/HER2- advanced breast cancer [3] - A Phase 1/2 clinical trial, CELC-G-201, is ongoing to assess gedatolisib in combination with darolutamide for metastatic castration-resistant prostate cancer [3] - Another Phase 3 clinical trial, VIKTORIA-2, is enrolling patients to evaluate gedatolisib plus a CDK4/6 inhibitor and fulvestrant as first-line treatment for HR+/HER2- advanced breast cancer [3] Upcoming Financial Results - Celcuity will release its financial results for the second quarter of 2025 after the market closes on August 14, 2025 [1] - Management will host a webcast/teleconference on the same day at 4:30 p.m. Eastern Time to discuss the results and provide a corporate update [1]