Celcuity Inc. Announces Plan to Initiate a Phase 3 Clinical Trial for Gedatolisib as First-Line Treatment for HR+/HER2- Advanced Breast Cancer and Secures Approximately $62 Million Debt Financing

Rhea-AI Summary

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.

Positive

• Initiation of a Phase 3 trial for gedatolisib targeting HR+/HER2- advanced breast cancer.
• Phase 1b results show median progression-free survival of 48.6 months and an ORR of 79%.
• Secured $62 million in additional debt financing to support the trial.
• Total debt facility increased to $180 million.
• FDA support for trial design.
• Global trial across 200 sites, enhancing research validity and reach.
• Flexible choice of CDK4/6 inhibitors (ribociclib or palbociclib) based on investigator’s discretion.

Negative

• Ongoing safety concerns as the combination of gedatolisib and ribociclib hasn't been clinically tested.
• Increased debt load, reaching $100 million immediately with potential for up to $180 million, impacting financial stability.
• Long timeline for trial completion and patient enrollment starting only in Q2 2025, delaying potential market entry.
• Dependency on achieving clinical and regulatory milestones to access additional debt tranches.

Insights

Medical Research Analyst

The initiation of a Phase 3 clinical trial for gedatolisib, in combination with a CDK4/6 inhibitor and fulvestrant, represents a significant advancement in the treatment landscape for HR+/HER2- advanced breast cancer patients who are endocrine therapy-resistant. The preliminary data from the Phase 1b trial is promising, with a median progression-free survival (PFS) of 48.6 months and an objective response rate (ORR) of 79%. This indicates a strong potential for gedatolisib to improve clinical outcomes for this patient population. However, it's important to monitor the results of the upcoming Phase 3 trial, particularly since the combination with ribociclib has not been previously tested. The trial's design, including the choice of CDK4/6 inhibitor and stratification by PIK3CA mutation status, should help in identifying patient subsets most likely to benefit from the treatment. If successful, this could provide a new viable first-line therapy option, potentially transforming standard care protocols and expanding treatment options for patients.

Financial Analyst

From a financial perspective, Celcuity's securing of an additional $62 million in debt financing is a strategic move to support their ambitious clinical trial plans. The amended agreement, which allows Celcuity to access up to $180 million in term loans, provides a significant capital influx necessary for the extensive Phase 3 trial. However, carrying a total debt of $100 million post-closing raises questions about the company's leverage and long-term financial health. The debt structure includes a 36-month interest-only period, extendable to 48 months and a five-year maturity, which provides some financial flexibility. Investors should weigh the potential high returns from a successfully commercialized drug against the risks associated with increased debt and the uncertainties of clinical trial outcomes. Continued monitoring of the company's financial performance and trial progress will be essential.

• The Phase 3 clinical trial will evaluate gedatolisib plus a CDK4/6 inhibitor and fulvestrant as first-line treatment for patients with HR+/HER2- advanced breast cancer who are endocrine therapy resistant
• Received an additional term loan of approximately $62 million in conjunction with an amendment to an existing debt facility agreement

MINNEAPOLIS, May 30, 2024 (GLOBE NEWSWIRE) -- Celcuity Inc. (Nasdaq: CELC), a clinical-stage biotechnology company pursuing development of targeted therapies for oncology, today announced that it plans to initiate a Phase 3 clinical trial to evaluate gedatolisib plus a CDK4/6 inhibitor and fulvestrant as first-line treatment for patients with HR+/HER2- advanced breast cancer (“ABC”) who are endocrine therapy resistant. In conjunction with its plan to conduct this study, Celcuity today entered into an amendment to an existing debt facility agreement and received an additional term loan of approximately $62 million.

“There is an urgent need for better first-line treatment options for HR+/HER2- advanced breast cancer patients whose disease progressed while on or within 12 months of completing adjuvant endocrine for early breast cancer,” said Igor Gorbatchevsky, MD, Chief Medical Officer of Celcuity. “We are very encouraged by the preliminary clinical data for gedatolisib as first-line treatment in patients with advanced breast cancer. In our Phase 1b trial that evaluated gedatolisib in combination with palbociclib and letrozole, median progression free survival was 48.6 months, and the ORR was 79%. These results highlighted the potential benefit of inhibiting the PI3K/AKT/mTOR pathway in treatment naïve patients.”

Phase 3 VIKTORIA-2 Clinical Trial
The Phase 3 VIKTORIA-2 clinical trial will be an open-label, randomized study to evaluate the efficacy and safety of gedatolisib combined with fulvestrant plus a CDK4/6 inhibitor in comparison to fulvestrant plus a CDK4/6 inhibitor as first-line treatment for patients with HR+/HER2- ABC who are endocrine therapy resistant. For the CDK4/6 inhibitor, investigators may choose either ribociclib or palbociclib. The safety profile of gedatolisib combined with fulvestrant and palbociclib is well described, but the investigational combination of gedatolisib with ribociclib has not yet been clinically tested. Therefore, a safety run-in of approximately 12-36 subjects will evaluate the safety profile of gedatolisib combined with ribociclib and fulvestrant. The safety run-in will be completed, and gedatolisib’s Phase 3 dose confirmed, before enrolling patients in the Phase 3 portion of the study.

For the Phase 3 study, approximately 638 subjects who meet the eligibility criteria will be assigned to a cohort based on their PIK3CA mutation status. After the investigator selects the CDK4/6 inhibitor for a subject, the subject will then be randomly assigned on a 1:1 basis to either Arm A (gedatolisib, fulvestrant, and Investigator’s choice of ribociclib or palbociclib) or Arm B (fulvestrant and Investigator’s choice of ribociclib or palbociclib).

The clinical trial primary endpoints are progression free survival ("PFS"), per RECIST 1.1 criteria, as assessed by blinded independent central review. The primary PFS endpoints will be evaluated separately in subjects who are PI3KCA wild type and PI3KCA mutant.

The study’s design was reviewed and discussed with the U.S. Food and Drug Administration ("FDA") during a Type C meeting.

This global trial is expected to enroll subjects at up to 200 clinical sites across North America, Europe, Latin America, and Asia. Celcuity expects to enroll the first patient in the second quarter of 2025.

“We are excited to have secured the additional capital so we could accelerate initiation of our second Phase 3 study,” said Brian Sullivan, CEO and co-founder of Celcuity. “Allowing investigators to choose between ribociclib or palbociclib as the CDK4/6 inhibitor for their patients, and separately randomizing patients according to their PIK3CA status, are important elements of the trial design. We are pleased that the FDA concurred with our approach.”

Amended debt financing agreement with Innovatus Capital Partners, LLC and Oxford Finance LLC
Today, Celcuity also amended its existing debt financing agreement with an affiliate of Innovatus Capital Partners, LLC (“Innovatus”) and added Oxford Finance LLC (“Oxford”) as a new lender to provide Celcuity with up to $180 million in term loans, a $105 million increase from the current debt financing agreement. At the closing of this amendment to the debt financing agreement, Celcuity will receive $61.7 million and will have $100 million of total debt outstanding. Celcuity will be able to draw an additional tranche of $30 million and an additional tranche of $50 million upon achievement of certain clinical trial and regulatory milestones. The amended debt facility has a 36-month interest only period, which can be extended to a 48-month period if certain conditions are met. The loans will mature on the fifth anniversary of the amended agreement date. The loan agreement includes customary warrant coverage and is secured by all of Celcuity’s assets. Armentum Partners LLC acted as sole advisor to Celcuity on this transaction.

About Celcuity
Celcuity is a clinical-stage biotechnology company focused on development of targeted therapies for treatment of multiple solid tumor indications. The company's lead therapeutic candidate is gedatolisib, a potent, pan-PI3K and mTOR inhibitor. Its mechanism of action and pharmacokinetic properties are highly differentiated from other currently approved and investigational therapies that target PI3K or mTOR 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- advanced breast cancer is currently enrolling patients. More detailed information about the VIKTORIA-1 study can be found at ClinicalTrials.gov. A Phase 1b/2 clinical trial, CELC-G-201, evaluating gedatolisib in combination with darolutamide in patients with metastatic castration resistant prostate cancer, is enrolling patients. 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- advanced breast cancer is expected to begin enrolling patients in the second quarter of 2025. The company’s CELsignia companion diagnostic platform is uniquely able to analyze live patient tumor cells to identify new groups of cancer patients likely to benefit from already approved targeted therapies. Celcuity is headquartered in Minneapolis. Further information about Celcuity can be found at www.celcuity.com. Follow us on LinkedIn and Twitter.

About Innovatus Capital Partners, LLC
Innovatus Capital Partners, LLC, is an independent adviser and portfolio management firm with approximately $1.7B in assets under management. Innovatus adheres to an investment strategy that identifies disruptive and growth opportunities across multiple asset categories with a unifying theme of capital preservation, income generation, and upside optionality. The firm has a dedicated team of life sciences investment professionals with deep experience in healthcare, including life sciences. Innovatus and its principals have significant experience providing debt financing to medical device, diagnostics, and biotechnology companies that address unmet medical needs, improve patient outcomes, and reduce overall healthcare expenditures.

About Oxford Finance
Oxford Finance LLC is a specialty finance firm providing senior secured loans to public and private life sciences and healthcare services companies worldwide. For over 20 years, Oxford has delivered flexible financing solutions to over 700 companies, allowing borrowers to maximize their equity by leveraging their assets. Since 2002, Oxford has originated more than $11 billion in loans. Oxford is headquartered in Alexandria, Virginia, with additional offices serving the greater San Diego, San Francisco, Boston and New York City metropolitan areas.

Cautionary Note Regarding Forward-Looking Statements
This press release contains statements that constitute “forward-looking statements” including, but not limited to, the design of our clinical trials; the timing of initiating and enrolling patients in, and receiving results and data from, our clinical trials; the costs and expected results from any ongoing or planned clinical trials; the market opportunity for gedatolisib; other expectations with respect to gedatolisib and our CELsignia platform; the expected use of proceeds from our recent financing activities; and the strength of our balance sheet. In some cases, you can identify forward-looking statements by terminology such as “may,” “should,” “expects,” “plans,” “anticipates,” “believes,” “estimates,” “predicts,” “potential,” “intends” or “continue,” and other similar expressions that are predictions of or indicate future events and future trends, or the negative of these terms or other comparable terminology. Forward-looking statements are subject to numerous risks, uncertainties, and conditions, many of which are beyond the control of Celcuity. These include, but are not limited to, unforeseen delays in our clinical trials, our ability to obtain and maintain regulatory approvals to commercialize our products, and the market acceptance of such products, the development of therapies and tools competitive with our products, and those risks set forth in the Risk Factors section in Celcuity’s Annual Report on Form 10-K for the year ended December 31, 2023 filed with the Securities and Exchange Commission on March 27, 2024. Readers are cautioned not to place undue reliance on these forward-looking statements, which speak only as of the date hereof. Celcuity undertakes no obligation to update these statements for revisions or changes after the date of this press release, except as required by law.

View source version of release on GlobeNewswire.com

Contacts:

Celcuity Inc.
Brian Sullivan, bsullivan@celcuity.com
Vicky Hahne, vhahne@celcuity.com
763-392-0123

ICR Westwicke
Maria Yonkoski, maria.yonkoski@westwicke.com
(619) 228-5886

SOURCE: Celcuity Inc.

FAQ

What is Celcuity's Phase 3 trial for?

The Phase 3 trial will evaluate gedatolisib plus a CDK4/6 inhibitor and fulvestrant as first-line treatment for HR+/HER2- advanced breast cancer.

When will Celcuity begin enrolling patients for the Phase 3 trial?

Celcuity expects to enroll the first patient in the second quarter of 2025.

How much financing did Celcuity secure for the Phase 3 trial?

Celcuity secured approximately $62 million in additional debt financing.

What is the primary endpoint of the Phase 3 VIKTORIA-2 trial?

The primary endpoint is progression-free survival (PFS) as assessed by blinded independent central review.

How many subjects will be enrolled in the Phase 3 VIKTORIA-2 trial?

Approximately 638 subjects will be enrolled.

What is the significance of the amendment to Celcuity's debt facility?

The amendment increases the total debt facility to $180 million, with $100 million outstanding and additional tranches available upon milestones.

Where will the Phase 3 VIKTORIA-2 trial be conducted?

The trial will be conducted at up to 200 clinical sites across North America, Europe, Latin America, and Asia.

What are the preliminary results of the Phase 1b trial for gedatolisib?

The Phase 1b trial showed a median progression-free survival of 48.6 months and an overall response rate of 79%.