Celcuity Inc. (CELC) is a clinical-stage biotechnology company focused on the development of targeted therapies for oncology. The company's lead therapeutic candidate is gedatolisib, a potent pan-PI3K/mTOR inhibitor with a highly differentiated mechanism of action and pharmacokinetic properties compared to other currently approved and investigational therapies targeting these pathways.

Business Overview

Celcuity's strong pipeline and innovative approach have positioned the company as a promising player in the oncology space. The company's flagship program, the Phase 3 VIKTORIA-1 trial evaluating gedatolisib in patients with HR+/HER2- advanced breast cancer, remains on track to report top-line data in the second half of 2024. Additionally, Celcuity recently initiated a Phase 1b/2 study (CELC-G-201) to evaluate gedatolisib in combination with darolutamide for the treatment of metastatic castration-resistant prostate cancer (mCRPC).

Financials

In the first quarter of 2024, Celcuity reported a net loss of $21.6 million, compared to a net loss of $11.9 million in the same period of 2023. The company's annual net income for the fiscal year 2023 was -$63,779,116, with no revenue generated. Operating cash flow for the year was -$53,814,969, and free cash flow was -$53,912,613.

The increase in net loss for the first quarter of 2024 was primarily driven by a $9.4 million, or 83%, increase in research and development expenses, which were $20.7 million, compared to $11.3 million in the same period of 2023. This increase was mainly related to costs supporting the VIKTORIA-1 Phase 3 trial and the initiation of the CELC-G-201 prostate cancer study. General and administrative expenses also increased by $0.5 million, or 45%, to $1.8 million in the first quarter of 2024, compared to $1.3 million in the same period of 2023.

Liquidity

Celcuity's cash, cash equivalents, and short-term investments totaled approximately $177.7 million as of March 31, 2024, providing the company with a strong financial position to advance its pipeline and support its operations. The company's balance sheet was bolstered by a $14 million cash inflow from the exercise of common stock warrants during the first quarter of 2024.

Lead Therapeutic Candidate: Gedatolisib

Gedatolisib, Celcuity's lead therapeutic candidate, is a potent, well-tolerated, small molecule reversible dual inhibitor that selectively targets all Class I isoforms of PI3K and mammalian target of rapamycin (mTOR). In April 2021, Celcuity obtained exclusive global development and commercialization rights to gedatolisib under a license agreement with Pfizer, Inc.

Celcuity believes gedatolisib's unique mechanism of action, differentiated chemical structure, favorable pharmacokinetic properties, and intravenous formulation offer distinct advantages over currently approved and investigational therapies that target PI3K or mTOR alone or together. The company's VIKTORIA-1 Phase 3 trial is evaluating the efficacy and safety of two regimens in adults with HR+/HER2- advanced breast cancer whose disease has progressed after prior CDK4/6 therapy in combination with an aromatase inhibitor: 1) gedatolisib in combination with palbociclib and fulvestrant; and 2) gedatolisib in combination with fulvestrant.

In addition to the breast cancer program, Celcuity is excited about the opportunity to develop gedatolisib for patients with metastatic castration-resistant prostate cancer (mCRPC). The company initiated a Phase 1b/2 study (CELC-G-201) in the first quarter of 2024 to evaluate gedatolisib in combination with darolutamide, an androgen receptor inhibitor, in mCRPC patients previously treated with an AR inhibitor.

CELsignia Diagnostic Platform

Celcuity's proprietary CELsignia diagnostic platform is the only commercially ready technology the company is aware of that uses a patient's living tumor cells to identify the specific abnormal cellular process driving a patient's cancer and the targeted therapy that best treats it. This enables Celcuity to identify patients whose tumors may respond to a targeted therapy, even though they lack a previously associated molecular mutation.

The company is supporting the advancement of new potential indications for three different targeted therapies, controlled by other pharmaceutical companies, that would rely on a CELsignia companion diagnostic to select patients. Three Phase 2 trials are underway to evaluate the efficacy and safety of these therapies in CELsignia-selected patients.

Celcuity's strategy of combining companion diagnostics designed to enable proprietary new drug indications with targeted therapies that treat signaling dysregulation its CDx identifies positions the company uniquely to improve the standard of care for many early and late-stage cancer patients. By leveraging the proprietary insights CELsignia provides into live patient tumor cell function, using a CELsignia CDx to identify new patients likely to respond to the paired targeted therapy, and developing new targeted therapeutic options, Celcuity aims to play a key role in the multiple treatment approaches required to treat cancer patients at various stages of their disease.

Recent Developments

Celcuity's recent developments include the dosing of the first patient in the CELC-G-201 Phase 1b/2 study evaluating gedatolisib in combination with darolutamide for the treatment of mCRPC. The company remains on track to report top-line data from the VIKTORIA-1 Phase 3 trial in the second half of 2024.

Outlook

Despite the company's net losses and negative cash flows, Celcuity's strong financial position, with approximately $177.7 million in cash, cash equivalents, and short-term investments as of March 31, 2024, provides the resources necessary to advance its pipeline and support its operations. The company's focus on developing innovative targeted therapies and companion diagnostics positions it well to capitalize on the growing demand for personalized cancer treatments and potentially transform the standard of care for various cancer indications.

Conclusion

As Celcuity continues to execute on its strategic priorities, investors will closely monitor the progress of the VIKTORIA-1 and CELC-G-201 trials, as well as the company's ability to further expand its pipeline and forge strategic partnerships to drive long-term growth and value creation.