On May 15, 2023 Celcuity Inc. (Nasdaq: CELC), a clinical-stage biotechnology company focused on development of targeted therapies for oncology, reported financial results for the first quarter ended March 31, 2023 and provided other recent corporate updates (Press release, Celcuity, MAY 15, 2023, View Source [SID1234631705]).

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"I am very pleased with the execution to date of our VIKTORIA-1 Phase 3 clinical trial enrollment activities at our trial sites. Our team is relentlessly focused and keeping us on track to deliver initial data in the second half of 2024," said Brian Sullivan, CEO and Co-Founder of Celcuity.

"The updated median progression free survival (mPFS) data for treatment-naïve HR+/HER2- advanced breast cancer patients we presented last week at the ESMO (Free ESMO Whitepaper) Breast Cancer Congress is very encouraging. The reported mPFS of 48.6 months compares very favorably to published data for available standards of care in this setting. In addition, the findings from the various nonclinical studies we presented at ASCO (Free ASCO Whitepaper)-GU and AACR (Free AACR Whitepaper) further highlight the benefit of inhibiting all Class I PI3K isoforms and MTOR1/MTORC2 and provide important input as we prioritize our clinical development plans."

First Quarter 2023 Business Highlights and Other Recent Developments

● Site activation and patient enrollment activities for the VIKTORIA-1 Phase 3 clinical trial remained on track to enable primary analysis of the PIK3CA WT sub-group in the second half of 2024. VIKTORIA-1 is evaluating gedatolisib in combination with fulvestrant, an endocrine therapy, with and without palbociclib, a CDK4/6 inhibitor, in adults with HR+/HER2- advanced breast cancer.

● In February 2023, the Company presented data from nonclinical studies evaluating gedatolisib and various PI3K, AKT, and mTOR inhibitors in prostate cancer cell lines at the American Society of Clinical Oncology (ASCO) (Free ASCO Whitepaper) Genitourinary Cancers Symposium. The studies demonstrated gedatolisib’s superior potency and efficacy relative to the various PI3K, AKT, and mTOR inhibitors, regardless of the cell lines’ PTEN or PI3K status.

● In April 2023, Celcuity presented a poster at the American Association for Cancer Research (AACR) (Free AACR Whitepaper) Annual Meeting reporting results from nonclinical studies evaluating gedatolisib and various PI3K, AKT, mTOR inhibitors in endometrial, ovarian and cervical cancer cell lines. The studies demonstrated gedatolisib’s superior therapeutic activity relative to the various PI3K, AKT, and mTOR inhibitors, regardless of the cell lines’ PTEN, PI3K, or AKT mutational status.

● In May 2023, updated results from a Phase 1b trial evaluating gedatolisib, in combination with palbociclib and the aromatase inhibitor, letrozole, were presented at the 2023 European Society for Medical Oncology (ESMO) (Free ESMO Whitepaper) Breast Cancer Annual Congress. The presentation reported efficacy and safety data in treatment-naïve patients with HR+/HER2- advanced breast cancer enrolled in Escalation Arm A and Expansion Arm A. Median progression-free survival (mPFS) and median duration of response (mDOR) data was updated as of March 16, 2023. For treatment-naïve patients in Escalation Arm A (n=11) and Expansion Arm A (n=30), median PFS was 45.8 months and 48.6 months, respectively. When treatment-naïve patients from both arms were combined (n=41), mPFS was 48.6 months and mDOR was 46.9 months. Median PFS in Expansion Arm A had not yet been reached when this data was reported at the San Antonio Breast Cancer Symposium last December.

● Enrollment is ongoing in the FACT-1 and FACT-2 trials for CELsignia selected patients who have early-stage HR+/HER2- breast cancer with interim results expected in the first half of 2024.

First Quarter 2023 Financial Results

Unless otherwise stated, all comparisons are for the first quarter ended March 31, 2023, compared to the first quarter ended March 31, 2022.

Total operating expenses were $12.5 million for the first quarter of 2023, compared to $7.5 million for the first quarter of 2022. Net cash used in operating activities for the first quarter of 2023 was $12.9 million, compared to $5.9 million for the first quarter of 2022.

Research and development (R&D) expenses were $11.3 million for the first quarter of 2023, compared to $6.7 million for the first quarter of 2022. The approximately $4.6 million increase was primarily the result of activities supporting the VIKTORIA-1 pivotal trial.

General and administrative (G&A) expenses were $1.3 million for the first quarter of 2023, compared to $0.8 million for the first quarter of 2022. The approximately $0.5 million increase was the result of non-cash based compensation and fees associated with being a public company.

Net loss for the first quarter of 2023 was $11.9 million, or $0.55 loss per share, compared to a net loss of $7.9 million, or $0.53 loss per share, for the first quarter of 2022. Non-GAAP adjusted net loss for the first quarter of 2023 was $10.2 million, or $0.47 loss per share, compared to non-GAAP adjusted net loss for the first quarter of 2022 of $7.0 million, or $0.47 per share. Non-GAAP adjusted net loss excludes stock-based compensation expense and non-cash interest expense. Because these items have no impact on Celcuity’s cash position, management believes non-GAAP adjusted net loss better enables Celcuity to focus on cash used in operations. For a reconciliation of financial measures calculated in accordance with generally accepted accounting principles in the United States (GAAP) to non-GAAP financial measures, please see the financial tables at the end of this press release.

At March 31, 2023, Celcuity had cash, cash equivalents and short-term investments of $157.5 million.