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Celcuity Inc. - $CELC STOCK NEWS

Welcome to our dedicated page for Celcuity news (Ticker: $CELC), a resource for investors and traders seeking the latest updates and insights on Celcuity stock.

Celcuity Inc. (Nasdaq: CELC) is a cutting-edge biotechnology company committed to developing targeted therapies for oncology. The company's proprietary functional cellular analysis platform offers a unique approach to personalized medicine by assessing the functionality of disease-related signaling pathways directly from a patient's diseased cells ex vivo. This innovative technology provides specific insights into how effectively a drug therapy impacts a patient's tumor cells, thereby transforming the treatment paradigm.

Celcuity's lead therapeutic candidate is gedatolisib, a potent, reversible dual inhibitor that targets all Class I PI3K isoforms and mTOR. Gedatolisib exhibits a highly differentiated mechanism of action and pharmacokinetic properties compared to other approved and investigational therapies that focus on PI3K or mTOR pathways individually or together. The company is actively pursuing multiple clinical trials to explore the efficacy of gedatolisib in various oncology indications.

Currently, Celcuity is enrolling patients for its Phase 3 VIKTORIA-1 clinical trial, which evaluates gedatolisib in combination with fulvestrant with or without palbociclib in patients with HR+/HER2- advanced breast cancer. The Phase 1b/2 clinical trial (CELC-G-201) is assessing gedatolisib in combination with darolutamide for treating metastatic castration-resistant prostate cancer (mCRPC).

In recent preclinical studies, gedatolisib has been shown to be more effective than single node PAM inhibitors in controlling crucial cellular functions necessary for cancer cell survival and proliferation. These promising results underline the potential of gedatolisib as a transformative treatment option for multiple solid tumor indications.

Celcuity has also announced the initiation of the Phase 3 VIKTORIA-2 clinical trial, which will evaluate gedatolisib plus a CDK4/6 inhibitor and fulvestrant as a first-line treatment for HR+/HER2- advanced breast cancer in patients who are endocrine therapy resistant. The trial is expected to start enrolling patients in the second quarter of 2025 and aims to add significant value to existing treatment protocols.

Celcuity's financial health is robust, supported by recent equity placements and a substantial debt facility agreement, which provides adequate capital to fund their operational activities into 2026. Further information about Celcuity, its pipeline, and ongoing clinical trials can be found on their official website.

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Celcuity (Nasdaq: CELC), a clinical-stage biotechnology firm focused on oncology therapies, announced its participation in the Jefferies Global Healthcare Conference from June 4-6, 2024, in New York.

Brian Sullivan, CEO and Co-founder, will engage in a fireside chat at 10:00 a.m. ET on June 6, 2024.

The event will be webcast live at this link: https://wsw.com/webcast/jeff302/celc/1809904, and accessible via the Investors section on Celcuity's website, with a replay available soon after.

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Celcuity (NASDAQ: CELC), a clinical-stage biotechnology company, announced the pricing of an underwritten offering of 3,871,000 shares of common stock at $15.50 per share, aiming to raise $60 million. Notable investors include BVF Partners L.P., Vivo Capital, and Eventide Asset Management. The offering is expected to close by May 31, 2024, pending customary conditions.

Proceeds are earmarked for working capital, corporate purposes, and a Phase 3 trial for advanced breast cancer treatment. Combined with existing cash and investments, these funds should cover expenses through late 2026. Leerink Partners, TD Cowen, and Stifel are joint bookrunning managers. The offering is registered under a previous SEC filing.

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Celcuity announced plans to initiate a Phase 3 trial for gedatolisib as first-line treatment for HR+/HER2- advanced breast cancer. The trial will assess gedatolisib combined with a CDK4/6 inhibitor and fulvestrant, targeting patients resistant to endocrine therapy. Initial trial results show promising efficacy, with a median progression-free survival of 48.6 months and an overall response rate of 79% in Phase 1b. Additionally, Celcuity secured $62 million in debt financing to support this initiative, amending its agreement with Innovatus Capital Partners and adding Oxford Finance as a new lender, increasing the total debt facility to $180 million. The Phase 3 trial, named VIKTORIA-2, will involve approximately 638 subjects across 200 global sites, with enrollment beginning in Q2 2025.

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Celcuity Inc. (Nasdaq: CELC) reported its first-quarter financial results and provided a corporate update. The Phase 3 VIKTORIA-1 trial remains on track, with topline data expected in the second half of 2024. The company also initiated a Phase 1b/2 trial for gedatolisib in prostate cancer, and dosed its first patient in February 2024. Financial highlights include a net loss of $21.6 million ($0.64 per share) for Q1 2024, compared to $11.9 million ($0.55 per share) in Q1 2023. Operating expenses rose to $22.5 million from $12.6 million year-over-year. Cash reserves stand at $177.7 million, expected to fund operations into early 2026.

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Celcuity Inc. (Nasdaq: CELC) will release its first quarter 2024 financial results on May 15, 2024, with a webcast/conference call hosted by management to discuss the results and provide a corporate update. The company is a clinical-stage biotechnology firm developing targeted oncology therapies.

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Celcuity Inc. announces CEO Brian Sullivan will present at investor conferences to discuss targeted therapies for oncology. The presentations will be at the Needham Virtual Healthcare Conference and Stifel Virtual Targeted Oncology Forum.
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Celcuity Inc. announced dosing the first patient in a Phase 1b/2 trial for metastatic castration resistant prostate cancer. They raised $65 million and expect funds to last until the first half of 2026. The company presented nonclinical data showing the superior effects of gedatolisib at a recent symposium. Financially, expenses increased, leading to a net loss, but they secured significant funding for future development.
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Celcuity Inc. (CELC) to release financial results for Q4 and full year 2023. Webcast scheduled for March 27, 2024, to discuss results and corporate update.
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Celcuity Inc. (CELC) to participate in Leerink Partners Global Biopharma Conference 2024. CEO Brian Sullivan to present on March 13, 2024. Live webcast details provided.
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Celcuity Inc. (CELC) to participate in Cowen’s 44th Annual Health Care Conference with CEO Brian Sullivan scheduled for a fireside chat. Live webcast details provided.
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FAQ

What does Celcuity Inc. specialize in?

Celcuity Inc. specializes in developing state-of-the-art cell-based assays to assess the functionality of disease-related signaling pathways and provide valuable insights into personalized medicine.

What is Celcuity's lead therapeutic candidate?

Celcuity's lead therapeutic candidate is gedatolisib, a potent dual inhibitor targeting all Class I PI3K isoforms and mTOR.

What clinical trials are currently underway at Celcuity?

Celcuity is currently enrolling patients for the Phase 3 VIKTORIA-1 trial and the Phase 1b/2 CELC-G-201 trial, evaluating gedatolisib in combination with other therapies for advanced breast cancer and metastatic castration-resistant prostate cancer, respectively.

What makes gedatolisib different from other cancer therapies?

Gedatolisib's mechanism of action and pharmacokinetic properties are highly differentiated, targeting all Class I PI3K isoforms and mTOR, which helps limit potential drug resistance.

What recent achievements has Celcuity accomplished?

Recent achievements include promising preclinical results for gedatolisib, initiation of new clinical trials, and securing financial stability through equity placements and debt agreements.

What is the VIKTORIA-2 clinical trial?

The VIKTORIA-2 clinical trial is an upcoming Phase 3 study that will evaluate gedatolisib combined with a CDK4/6 inhibitor and fulvestrant as first-line treatment for HR+/HER2- advanced breast cancer.

How does Celcuity's functional cellular analysis platform work?

Celcuity's platform directly assesses the functionality of disease-related signaling pathways from a patient's diseased cells ex vivo, offering unique insights into how drug therapies impact those cells.

What financial condition is Celcuity in?

Celcuity is in a strong financial position with significant cash reserves, supported by recent equity placements and an expanded debt facility agreement.

Where can I find more information about Celcuity?

More detailed information about Celcuity can be found on their official website, www.celcuity.com.

What is the purpose of the CELsignia companion diagnostic platform?

The CELsignia platform analyzes live patient tumor cells to identify cancer patients likely to benefit from already approved targeted therapies.

Celcuity Inc.

Nasdaq:CELC

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About CELC

celcuity is a biotech company developing state-of-the-art cell-based assays using our proprietary functional cellular analysis platform. we directly assess the functionality of the disease-related signaling pathways of a patient's diseased cells ex vivo to determine whether a drug therapy has the intended effect on those cells. the patient specific cellular data we provide offers clinicians and pharmaceutical companies unique insight into a patient's response to a drug therapy, and it will change the paradigm of personalized medicine.