10-Q: Celcuity Reports Strong Phase 3 Data, Boosts Capital

Celcuity Inc. announced positive topline Phase 3 VIKTORIA-1 data for gedatolisib in breast cancer and secured over $286 million in new capital to extend its operational runway through 2027.

Summary

• Celcuity reported a net loss of $45.3 million for the three months ended June 30, 2025, compared to $23.7 million for the same period in 2024, and $82.3 million for the six months ended June 30, 2025, compared to $45.3 million in 2024.
• Research and development expenses increased by 79% to $40.2 million for the three months ended June 30, 2025, and by 68% to $72.4 million for the six months ended June 30, 2025, primarily due to increased clinical trial activities and a $5.0 million anticipated milestone payment to Pfizer.
• General and administrative expenses rose by 112% to $3.8 million for the three months and $7.7 million for the six months ended June 30, 2025.
• Cash and cash equivalents stood at $46.4 million, and investments at $122.0 million as of June 30, 2025.
• Topline data from the PIK3CA wild-type cohort of the Phase 3 VIKTORIA-1 clinical trial showed gedatolisib triplet reduced disease progression or death risk by 76% (HR 0.24) and the doublet by 67% (HR 0.33) compared to fulvestrant alone.
• Median progression-free survival (PFS) for the gedatolisib triplet was 9.3 months versus 2.0 months for fulvestrant, an incremental improvement of 7.3 months.
• Median PFS for the gedatolisib doublet was 7.4 months versus 2.0 months for fulvestrant, an incremental improvement of 5.4 months.
• The company expects to submit a New Drug Application (NDA) for gedatolisib to the FDA in the fourth quarter of 2025.
• A Phase 3 clinical trial, VIKTORIA-2, for first-line treatment of endocrine treatment resistant HR+/HER2advanced breast cancer, began enrolling patients in July 2025.
• Topline data from the Phase 1b portion of the CELC-G-201 trial in mCRPC showed a six-month radiographic PFS of 66%, with no discontinuations due to treatment-related adverse events or dose reductions.
• Successfully completed an Equity Offering and a Convertible Notes Offering in July/August 2025, raising approximately $91.6 million and $194.9 million in net proceeds, respectively.
• Exercised warrants generated an additional $10.4 million in July 2025 and $1.6 million in August 2025.
• Achieved the Term D Milestone under the A&R Loan Agreement, making the company eligible to draw an additional $30.0 million in late August 2025.
• A new U.S. patent (No. 12,350,276) was issued on July 8, 2025, extending gedatolisib's patent exclusivity in the U.S. into August 2042.

Sentiment

Score: 9

Explanation: The filing presents exceptionally strong positive clinical trial results for its lead candidate, gedatolisib, in a significant Phase 3 breast cancer cohort, which is a major de-risking event for a clinical-stage biotech. This is coupled with highly successful capital raises that significantly extend the company's financial runway. While losses increased, this is expected for a company advancing multiple late-stage clinical programs. The overall outlook is very positive due to clinical validation and strengthened financial position.

Positives

• Gedatolisib triplet demonstrated a statistically significant and clinically meaningful improvement in PFS in the VIKTORIA-1 PIK3CA WT cohort, reducing disease progression or death risk by 76% (HR 0.24) compared to fulvestrant.
• The gedatolisib doublet also showed significant PFS improvement, reducing risk by 67% (HR 0.33) compared to fulvestrant.
• The 7.3-month and 5.4-month incremental PFS improvements for the triplet and doublet, respectively, are higher than any previously reported Phase 3 trial for HR+/HER2advanced breast cancer patients receiving at least second-line therapy.
• Gedatolisib is the first PI3K/AKT/mTOR pathway inhibitor to demonstrate positive Phase 3 results in HR+/HER2-/PIK3CA wild-type advanced breast cancer patients whose disease progressed on or after CDK 4/6 inhibitor treatment.
• Both gedatolisib regimens in VIKTORIA-1 showed lower rates of hyperglycemia and stomatitis, and lower discontinuation rates due to treatment-related adverse events compared to a prior Phase 1b study.
• Successful completion of a July 2025 Equity Offering, raising approximately $91.6 million in net proceeds.
• Successful completion of a July 2025 Convertible Notes Offering, raising approximately $194.9 million in net proceeds.
• Exercise of warrants in March, July, and August 2025 generated significant cash proceeds of $5.6 million, $10.4 million, and $1.6 million, respectively.
• Achievement of the Term D Milestone under the A&R Loan Agreement makes the company eligible for an additional $30.0 million draw.
• New U.S. Patent No. 12,350,276 extends gedatolisib's patent exclusivity in the U.S. into August 2042, strengthening intellectual property.
• The Phase 1b portion of the CELC-G-201 trial in mCRPC showed a promising 66% six-month radiographic PFS, with good tolerability (no discontinuations due to treatment-related AE, no Grade 3 hyperglycemia).

Negatives

• Net loss significantly increased to $45.3 million for Q2 2025 from $23.7 million for Q2 2024, and to $82.3 million for H1 2025 from $45.3 million for H1 2024.
• Research and development expenses increased substantially due to ongoing clinical trials and a $5.0 million milestone payment, contributing to higher losses.
• General and administrative expenses more than doubled, reflecting expanding infrastructure and public company costs.
• Interest income decreased due to lower market interest rates and lower average cash balances in the current period.

Risks

• The company has a limited operating history and has not generated any revenue to date, incurring significant losses since inception.
• Potential inability to develop, validate, obtain regulatory approval for, and commercialize gedatolisib on a timely basis or at all.
• Uncertainties and costs associated with clinical studies and with developing and commercializing biopharmaceuticals.
• Complexity and difficulty of demonstrating the safety and sufficient magnitude of benefit to support regulatory approval of gedatolisib.
• Challenges in developing and maintaining relationships with pharmaceutical company partners.
• Uncertainty regarding market acceptance by physicians, patients, third-party payors, and others in the medical community.
• Difficulties in managing growth, including hiring and retaining a qualified sales force and key personnel.
• Changes in government regulations, including tax laws and regulations, and those affecting operations and laboratories.
• Tightening credit markets and limitations on access to capital, or stock market volatility affecting ability to access capital on favorable terms.
• Indebtedness and liabilities could limit cash flow available for operations, expose the company to risks, and impair ability to satisfy debt obligations.
• Inability to raise necessary funds to repurchase convertible notes following a fundamental change or to pay cash amounts due upon maturity.
• Provisions in the Indenture for convertible notes could delay or prevent an otherwise beneficial takeover.

Future Outlook

The company plans to increase research and development expenses as it continues to develop gedatolisib, including ongoing Phase 3 VIKTORIA-1 and VIKTORIA-2 clinical trials, and the Phase 1b/2 CELC-G-201 clinical trial. An NDA for gedatolisib is expected to be submitted to the FDA in the fourth quarter of 2025. General and administrative expenses are also anticipated to increase in future periods due to potential commercialization efforts, expanding infrastructure, and public company compliance costs. The company believes its current cash, cash equivalents, and short-term investments, including proceeds from recent financings and available borrowings, will provide sufficient cash to fund operations through 2027. Additional capital may be sought to finance future expenditures and business expansion.

Management Comments

• We expect to submit an NDA to the FDA in the fourth quarter of 2025 seeking approval for gedatolisib in combination with fulvestrant and with or without palbociclib for the treatment of adults with endocrine therapy resistant HR+/HER2advanced breast cancer following progression on or after treatment with a CDK 4/6 inhibitor in combination with endocrine therapy.
• We intend to use the net proceeds from the Equity Offering and Note Offering for working capital and general corporate purposes, which may include capital expenditures, research and development expenditures, clinical trial expenditures, commercial launch expenditures, expansion of business development activities and other general corporate purposes.
• Based on our current business plan, we believe that our current cash, cash equivalents and short-term investments, including amounts received upon the closing of the Equity Offering and Note Offering, together with available borrowings under the A&R Loan Agreement, will provide sufficient cash to finance our operations through 2027.

Industry Context

Celcuity's gedatolisib, a pan-Class I PI3K and mTORC1/2 inhibitor, aims to overcome limitations of single-isoform or single-node inhibitors in the PI3K/AKT/mTOR pathway, which often face compensatory resistance. Its intravenous administration and favorable safety profile, particularly lower rates of hyperglycemia and stomatitis compared to oral PI3K/mTOR drugs, position it as a potentially differentiated therapy in the competitive oncology landscape. The positive Phase 3 results in a specific breast cancer patient population (HR+/HER2-/PIK3CA WT post-CDK 4/6 inhibitor) are significant, as gedatolisib is noted as the first inhibitor targeting this pathway to achieve such results in this subgroup, potentially addressing an unmet need where other therapies have struggled with efficacy or tolerability.

Comparison to Industry Standards

• In the B2151009 Phase 1b trial, gedatolisib combined with palbociclib and endocrine therapy achieved an Objective Overall Response Rate (ORR) of 85% in treatment-naive patients (Arm A), which compares favorably to the 55% ORR from the PALOMA-2 study (palbociclib plus letrozole).
• For patients who received prior hormonal therapy alone or with a CDK 4/6 inhibitor (Arms B, C, and D), gedatolisib combinations showed ORRs ranging from 36% to 77%, exceeding the 25% ORR from the PALOMA-3 study (palbociclib plus fulvestrant).
• Median Progression-Free Survival (PFS) for all treatment-naive patients in Expansion Arm A and Escalation Arm A (N=41) was 48.6 months, with an ORR of 79%, which the company states compares favorably to published data for current first-line standard-of-care treatments for HR+/HER2advanced breast cancer.
• In the VIKTORIA-1 PIK3CA WT cohort, the hazard ratios for the gedatolisib triplet (0.24) and doublet (0.33) are stated to be more favorable than any ever reported by any Phase 3 trial for patients with HR+/HER2advanced breast cancer.
• The 7.3-month and 5.4-month incremental improvements in median PFS for the gedatolisib triplet and doublet over fulvestrant, respectively, are highlighted as higher than any ever reported by any Phase 3 trial for patients with HR+/HER2advanced breast cancer receiving at least their second line of therapy.
• Gedatolisib's safety profile in the Phase 1b trial showed only 7% of patients experienced Grade 3 or 4 hyperglycemia and less than 9% discontinued treatment, contrasting with PIQRAY (an FDA approved oral p110-specific inhibitor) which induced Grade 3 or 4 hyperglycemia in 39% of patients and led to 26% discontinuing due to treatment-related AEs in its Phase 3 pivotal trial.

Corporate Governance

Legal Proceedings

• Not currently a party to any legal proceedings that could reasonably be expected to have a material adverse effect on business, financial condition, and results of operations.

Related Party Transactions

• Innovatus Life Sciences Lending Fund I, LP, as a lender under the A&R Loan Agreement, has the right to convert up to 20% of the outstanding principal of the Term A Loan into common stock at $10.00 per share, extended to May 9, 2026.
• Innovatus also holds a warrant to purchase 26,042 shares of common stock at $14.40 per share through April 8, 2031.
• Brightstone, where David Dalvey is a General Partner, adopted a 10b5-1 plan on June 13, 2025, for the sale of up to 229,335 shares of Celcuity Inc. common stock from December 15, 2025, through December 15, 2026.

Stakeholder Impact

• **Shareholders:** Significant dilution from recent equity and convertible notes offerings (issuance of 1,836,842 shares, 400,000 pre-funded warrants, and potential conversion of $201.25 million in notes), but potential for substantial value creation from positive Phase 3 clinical trial results and extended cash runway.
• **Employees:** Continued stock-based compensation and employee stock purchase plan, providing incentives and opportunities for ownership.
• **Patients:** Positive clinical trial results for gedatolisib offer hope for new, potentially more effective and better-tolerated treatment options for advanced breast cancer and prostate cancer.
• **Creditors (Innovatus, Oxford):** Loan agreements provide security over company assets and include financial covenants, with Innovatus having conversion rights and warrants, ensuring their interests are protected.
• **Pfizer:** Entitled to milestone payments (including a $5.0 million payment upon NDA filing) and tiered royalties on future sales of gedatolisib, benefiting from the drug's development and potential commercialization.

Next Steps

• Continue enrollment of Cohort 2 (PIK3CA mutant-type) in the VIKTORIA-1 Phase 3 clinical trial.
• Expect topline data for the VIKTORIA-1 PIK3CA MT cohort in the fourth quarter of 2025.
• Continue enrolling patients in the VIKTORIA-2 Phase 3 clinical trial.
• Determine the Recommended Phase 2 Dose (RP2D) for gedatolisib in the CELC-G-201 Phase 1b/2 trial and enroll an additional 12 participants in the Phase 2 portion.
• Present additional preliminary results for the CELC-G-201 Phase 1b portion at a medical conference later this year.
• Present full data from the PIK3CA wild-type cohort of the VIKTORIA-1 clinical trial at an upcoming medical conference later this year.
• Submit a New Drug Application (NDA) for gedatolisib to the FDA in the fourth quarter of 2025.
• Draw down the additional $30.0 million from the Term D Loan in late August 2025.
• Potentially draw on a fifth tranche of $50 million (Term E Loan) upon achievement of certain clinical trial milestones and satisfaction of financial covenants.
• Potentially draw on additional term loans of $45 million (Term F Loan) at the Lenders' sole discretion upon company request.

Key Dates

Recommendation

The filing contains exceptionally strong positive Phase 3 clinical trial data for gedatolisib in a significant and challenging patient population (HR+/HER2-/PIK3CA WT advanced breast cancer post-CDK 4/6 inhibitor), demonstrating superior efficacy metrics (HR and incremental PFS) compared to historical benchmarks. This de-risks the lead asset significantly and positions the company for an NDA submission in Q4 2025. Furthermore, the successful completion of substantial equity and convertible notes offerings, raising over $286 million in net proceeds, coupled with additional warrant exercises and loan draws, provides a robust financial runway through 2027. This strong clinical validation combined with a significantly improved liquidity position makes Celcuity a compelling 'strong buy' for investors seeking exposure to a de-risked clinical-stage biotechnology company with a clear path to market.

Keywords

Biotechnology, Clinical-stage, Gedatolisib, Breast Cancer, Prostate Cancer, PI3K/AKT/mTOR inhibitor, Phase 3 Clinical Trial, VIKTORIA-1, VIKTORIA-2, CELC-G-201, Oncology, Targeted Therapy, SEC Filing, 10-Q, Capital Raise, Convertible Notes, Equity Offering, Patent, FDA NDA