On May 10, 2021 Celcuity Inc. (NASDAQ:CELC), a clinical-stage biotechnology company pursuing an integrated companion diagnostic (CDx) and therapeutic strategy for treating patients with cancer, reported financial results for the first quarter ended March 31, 2021 and summarized recent business progress (Press release, Celcuity, MAY 10, 2021, View Source [SID1234580661]).

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"Celcuity took a transformational strategic step in April when we entered into a global licensing agreement with Pfizer to obtain exclusive rights to develop and commercialize gedatolisib, a pan-PI3K/mTOR inhibitor, in clinical development to treat patients with ER+/HER2-negative advanced or metastatic breast cancer," said Brian Sullivan, CEO and co-founder of Celcuity. "Celcuity is planning to initiate, subject to feedback from the FDA, a Phase 2/3 clinical trial evaluating gedatolisib in combination with palbociclib and an endocrine therapy in the first half of 2022. We have a highly experienced drug development team and the financial resources in place to advance the gedatolisib program and are excited by the opportunity to utilize our CELsignia cellular analysis platform to support the development of a potential first-in-class targeted cancer therapy like gedatolisib."

First Quarter 2021 Business Highlights and Other Recent Developments

In January, Celcuity entered a collaboration with Sarah Cannon Research Institute and Pfizer Inc. to conduct an open-label Phase 2 clinical trial. This trial will evaluate the efficacy and safety of two Pfizer targeted therapies, VIZIMPRO, a pan-HER inhibitor, and XALKORI, a c-Met inhibitor, in patients with previously treated metastatic HER2-negative breast cancer selected with Celcuity’s CELsignia Multi-Pathway Activity Test. Celcuity believes there is significant clinical interest in finding new diagnostic tests and targeted therapies for patients with metastatic HER2-negative breast cancer whose disease progressed on prior therapies. Patient enrollment is expected to begin in the second or third quarter of 2021 with interim results in the second half of 2022.
Celcuity raised approximately $43.0 million of gross proceeds from financings in the first quarter of 2021 and April 2021.
In late February, Celcuity completed a successful follow-on public offering that raised gross proceeds of approximately $27.6 million.
In early April, Celcuity entered into a debt financing agreement with Innovatus Life Sciences Lending Fund I, LP to provide up to $25.0 million in term loans with the first tranche of $15.0 million funded at closing. Celcuity will be able to draw on two additional tranches of $5.0 million each upon the achievement of certain clinical trial and financing milestones.
In March, Celcuity entered into a clinical trial collaboration with MD Anderson, Novartis, and Puma Biotechnology to evaluate the efficacy and safety of Novartis’ targeted therapy TABRECTA and Puma’s NERLYNX in patients with metastatic HER2-negative breast cancer selected by Celcuity’s CELsignia Multi-Pathway Activity Test. This is Celcuity’s second clinical trial to treat patients diagnosed with hyperactive HER2 and c-Met signaling breast cancers with matching targeted therapies and Celcuity now has five clinical trial collaborations in place.
In April, Celcuity entered a worldwide licensing agreement with Pfizer for the exclusive right to develop and commercialize gedatolisib. Gedatolisib is in Phase 1b clinical development for the treatment of patients with ER+/HER2-negative advanced or metastatic breast cancer. Celcuity announced preliminary data for the 103 patients enrolled in the expansion portion of the ongoing Phase 1b clinical trial evaluating gedatolisib, plus Ibrance and endocrine therapy. As of the January 11, 2021 data cut-off, 53 of the 88 evaluable patients (60%) had an objective response. Gedatolisib was also generally well tolerated, with the majority of treatment-related adverse events (TRAE) being Grade 1 or 2. The most common Grade 3 or 4 TRAEs related to gedatolisib were stomatitis and rash. Celcuity plans to meet with the FDA later this year to discuss its clinical development plans for gedatolisib.
In April, Celcuity presented results of studies evaluating gedatolisib, inavolisib (a PI3K-α inhibitor), and navitoclax (a BCL inhibitor) in breast and ovarian patient tumors in two posters at the American Association for Cancer Research (AACR) (Free AACR Whitepaper) Annual Meeting. The results showed that gedatolisib inhibited nine times more signaling test activity in tumors with hyperactive RAS network signaling, on average, than inavolisib, when evaluated at equal concentrations with the CELsignia test. Gedatolisib at one-fifth the concentration of inavolisib (30 nM vs. 150 nM), inhibited five times more signaling activity as quantified by the CELsignia test. Data also showed that synergistic cooperation between PI3K/mTOR and BCL signaling was detected, suggesting potential patient benefit of combining gedatolisib with a BCL inhibitor.
First Quarter 2021 Financial Results
Unless otherwise stated, all comparisons are for the first quarter ended March 31, 2021, compared to the first quarter ended March 31, 2020.

Total operating expenses were $2.79 million for the first quarter of 2021, compared to $2.31 million for the first quarter of 2020.

Research and development (R&D) expenses were $2.24 million for the first quarter of 2021, compared to $1.85 million for the first quarter of 2020. The approximately $0.39 million increase during the first three months of fiscal year 2021, compared to the first three months of fiscal year 2020, resulted from a $0.06 million increase in compensation related expenses, which included a decrease of approximately $0.04 million of non-cash stock-based compensation expense. In addition, other research and development expenses increased $0.33 million due to clinical validation and laboratory studies, and operational and business development activities.

General and administrative (G&A) expenses were $0.56 million for the first quarter of 2021, compared to $0.46 million for the first quarter of 2020. The approximately $0.09 million increase during the first three months of fiscal year 2021, compared to the first three months of fiscal year 2020, resulted primarily from a $0.08 million increase in professional fees associated with being a public company and director and officer insurance.

Net loss for the first quarter of 2021 was $2.79 million, or $0.25 per share, compared to a net loss of $2.25 million, or $0.22 per share, for the first quarter of 2020. Non-GAAP adjusted net loss for the first quarter of 2021 was $2.34 million, or $0.21 per share, compared to non-GAAP adjusted net loss of $1.78 million, or $0.17 per share, for the first quarter of 2020. Non-GAAP adjusted net loss excludes stock-based compensation expense. Because this item has 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.

Net cash used in operating activities for the first quarter of 2021 was $2.52 million, compared to $1.83 million for the first quarter of 2020.

At March 31, 2021, Celcuity had cash and cash equivalents of $34.9 million, compared to cash and cash equivalents of $11.6 million at December 31, 2020. On April 8, 2021, Celcuity paid an upfront license fee of $5.0 million in conjunction with the Pfizer gedatolisib license agreement and received $14.5 million of net proceeds from a debt financing agreement. Taking into account these two events subsequent to the end of the first quarter, Celcuity has approximately $44.0 million of cash-on-hand.

Anticipated Milestones
Celcuity expects to do the following over the next twelve months:

Announce additional clinical trial collaborations in the first half of 2021 utilizing the CELsignia platform.
Initiate Phase 2/3 clinical trial for gedatolisib in breast cancer in the first half of 2022 pending discussions with the FDA regarding the clinical development pathway.
Provide interim results from the FACT-1 and FACT-2 trials in late 2021 or early 2022.
Webcast and Conference Call Information
The Celcuity management team will host a webcast/conference call at 4:30 p.m. ET today to discuss the first quarter financial results and provide a corporate update. To participate in the teleconference, domestic callers should dial 1-877-407-8035 and international callers should dial 201-689-8035. A live webcast presentation can also be accessed using this weblink: View Source A replay of the webcast will be available on the Celcuity website following the live event.