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Celcuity to Present at Upcoming Guggenheim Emerging Outlook: Biotech Summit 2026

MWN-AI** Summary

Celcuity Inc. (Nasdaq: CELC), a clinical-stage biotechnology company focused on developing targeted therapies for cancer, will participate in the upcoming Guggenheim Emerging Outlook: Biotech Summit 2026 in New York on February 11-12, 2026. Brian Sullivan, the company’s CEO and co-founder, is slated to engage in a fireside chat on February 11 at 9:30 a.m. ET. Those interested can watch the live webcast through a designated link or via the Investors section of Celcuity’s official website, where a replay will also be made available shortly after.

Celcuity is advancing its lead therapeutic candidate, gedatolisib, a potent inhibitor targeting the PI3K/AKT/mTOR pathway—key in various solid tumors. This innovative therapy sets itself apart by blocking the pathway comprehensively, unlike other therapies that focus on single targets. Currently, Celcuity's clinical pipeline includes several significant trials. The Phase 3 VIKTORIA-1 trial is exploring gedatolisib in combination with fulvestrant, with enrollment completed for PIK3CA wild-type patients, while also enrolling the PIK3CA mutant cohort. Additionally, the Phase 3 VIKTORIA-2 trial is investigating gedatolisib combined with a CDK4/6 inhibitor and fulvestrant for patients with HR+/HER2- advanced breast cancer, which is actively enrolling participants. The Phase 1/2 trial CELC-G-201 is also underway, focusing on patients with metastatic castration-resistant prostate cancer.

Celcuity is headquartered in Minneapolis, and further details about its ongoing clinical trials can be accessed on ClinicalTrials.gov. For more information about the company and its innovative therapies, visit Celcuity's website or connect on LinkedIn and X.

MWN-AI** Analysis

As Celcuity Inc. (Nasdaq: CELC) prepares to present at the Guggenheim Emerging Outlook: Biotech Summit 2026, there are several key factors for investors to consider regarding the company’s strategic direction and market potential.

Celcuity's proprietary lead candidate, gedatolisib, is a pan-PI3K and mTORC1/2 inhibitor, addressing the critical PI3K/AKT/mTOR pathway implicated in various cancers. The uniqueness of gedatolisib lies in its ability to simultaneously target multiple pathways, potentially offering differentiated efficacy compared to other therapies limited to targeting PI3K or mTOR alone. This mechanism positions Celcuity favorably in the intense oncology market.

As of early 2026, the company has completed enrollment in its Phase 3 VIKTORIA-1 clinical trial, which evaluates gedatolisib in patients with hormone receptor-positive, HER2-negative advanced breast cancer (HR+/HER2- ABC). Investors should closely monitor upcoming results from this trial, as positive outcomes could significantly bolster the stock's valuation. The ongoing VIKTORIA-2 trial further demonstrates Celcuity's commitment to expanding its clinical footprint, with the inclusion of a CDK4/6 inhibitor combining with gedatolisib, highlighting the potential for enhanced treatment options in first-line therapy scenarios.

Celcuity's presence at the Guggenheim summit provides a vital platform for management to articulate the company’s future direction and engage with potential investors. Market reactions may hinge on the clarity and enthusiasm of the messaging around upcoming trial data. Consequently, investors should watch for updates post-event, particularly with regard to trial timelines and potential partnerships, as these could greatly influence the company’s trajectory.

Given the highly speculative nature of biotech investments, stakeholders should approach Celcuity with a balanced view—recognizing both the high potential rewards from successful trial outcomes and the inherent risks involved in clinical-stage developments.

**MWN-AI Summary and Analysis is based on asking OpenAI to summarize and analyze this news release.

Source: GlobeNewswire

MINNEAPOLIS, Feb. 04, 2026 (GLOBE NEWSWIRE) -- Celcuity Inc. (Nasdaq: CELC), a clinical-stage biotechnology company pursuing development of targeted therapies for oncology, today announced its participation in the Guggenheim Emerging Outlook: Biotech Summit 2026 to be held in New York, New York on February 11-12, 2026.

Brian Sullivan, Chief Executive Officer and Co-founder of Celcuity, is scheduled for a fireside chat at 9:30 a.m. ET on Wednesday, February 11, 2026. A live webcast of the event will be available using this weblink https://event.summitcast.com/view/kbtj9ZAiVkB78KPZiu5dZ9/2Q8oLmGM98qWAwr5LXWSr8. Alternatively, the live webcast will be accessible from the Investors section of the company's website at https://ir.celcuity.com/events-presentations/ with a replay available shortly after.

About Celcuity

Celcuity is a clinical-stage biotechnology company pursuing the development of targeted therapies for the treatment of multiple solid tumor indications. The company's lead therapeutic candidate is gedatolisib, a potent, pan-PI3K and mTORC1/2 inhibitor that comprehensively blockades the PI3K/AKT/mTOR (“PAM”) pathway. Its mechanism of action and pharmacokinetic properties are differentiated from other currently approved and investigational therapies that target PI3K?, AKT, or mTORC1 alone or together. A Phase 3 clinical trial, VIKTORIA-1, evaluating gedatolisib in combination with fulvestrant with or without palbociclib in patients with HR+/HER2- ABC, has completed enrollment and the company has reported detailed results for the PIK3CA wild-type cohort and has completed enrollment of patients for the PIK3CA mutant cohort.  A Phase 3 clinical trial, VIKTORIA-2, evaluating gedatolisib plus a CDK4/6 inhibitor and fulvestrant as first-line treatment for patients with HR+/HER2- ABC, is currently enrolling patients. A Phase 1/2 clinical trial, CELC-G-201, evaluating gedatolisib in combination with darolutamide in patients with metastatic castration resistant prostate cancer, is ongoing. More detailed information about Celcuity’s active clinical trials can be found at ClinicalTrials.gov. Celcuity is headquartered in Minneapolis. Further information about Celcuity can be found at www.celcuity.com. Follow us on LinkedIn and X.

Contacts: 

Celcuity Inc. 
Brian Sullivan, bsullivan@celcuity.com 
Vicky Hahne, vhahne@celcuity.com 
(763) 392-0123
Jodi Sievers, jsievers@celcuity.com
(415) 494-9924


FAQ**

How is Celcuity Inc. (CELC) positioned in the competitive landscape of oncology therapies, especially with its lead candidate gedatolisib targeting the PI3K/AKT/mTOR pathway?

Celcuity Inc. (CELC) strategically positions itself in the oncology landscape with gedatolisib, its lead candidate targeting the PI3K/AKT/mTOR pathway, by focusing on precision medicine and exploiting biomarkers to address unmet needs in cancer treatment.

What are the key milestones and expected timelines for the Phase 3 clinical trials VIKTORIA-1 and VIKTORIA-2 that involve Celcuity Inc. (CELC) and its therapeutic strategies?

As of October 2023, key milestones for Celcuity Inc.'s Phase 3 trials VIKTORIA-1 and VIKTORIA-2 include the anticipated completion of patient enrollment and data analysis by late 2024, with potential results expected in early 2025, focusing on their therapeutic strategies.

How does Celcuity Inc. (CELC) plan to differentiate gedatolisib from other therapies in development, particularly in its mechanism of action and pharmacokinetics?

Celcuity Inc. (CELC) aims to differentiate gedatolisib by focusing on its unique mechanism of action that targets specific cancer pathways and its favorable pharmacokinetic profile that enhances bioavailability and efficacy compared to other therapies in development.

What insights can investors expect from Brian Sullivan during the fireside chat at the Guggenheim Emerging Outlook: Biotech Summit 2026 regarding the future of Celcuity Inc. (CELC) and its therapeutic pipeline?

Investors can anticipate Brian Sullivan sharing strategic perspectives on Celcuity Inc.'s innovative therapeutic pipeline and its potential market impact, along with insights on industry trends influencing the biotech sector's future during the Guggenheim summit.

**MWN-AI FAQ is based on asking OpenAI questions about Celcuity Inc. (NASDAQ: CELC).

Celcuity Inc.

NASDAQ: CELC

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CELC Stock Data

$4,814,524,499
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68
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Biotechnology & Life Sciences
Healthcare
US
Minneapolis

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