Celcuity Inc. (CELC) stock has gained 28.09%, as of this writing in the Friday, April 9, 2021, pre-market session.
Let’s try to figure out the reasons behind its surging.
Announcement of preliminary data from Phase 1b clinical trial
On April 8, 2021, Celcuity Inc. reported preliminary data of an ongoing Phase 1b clinical trial evaluating gedatolisib, a first-in-class PI3K/mTOR inhibitor, plus Ibrance and endocrine therapy, in ER+/HER2- advanced or metastatic breast cancer patients.
53 patients 60%) had an objective response. Gedatolisib provided good results and common Grade 3 or 4 TRAEs related to gedatolisib were stomatitis and rash.
The license agreement with Pfizer
On April 8, 2021, Celcuity also announced the global licensing agreement with Pfizer Inc. Pfizer will providedCelcuity with a worldwide license to develop and commercialize gedatolisib.
The deal is done for5 million of cash and $5 million of Celcuity’s common stock as upfront payment.
Collaboration with three major companies
On March 17, 2021, Celcuity announced a collaboration with the MD Anderson Cancer Center, Novartis AG, and Puma Biotechnology, Inc, to conduct a breast cancer Phase II clinical trial.
Phase II clinical trial will be carried out to evaluate the efficacy and safety of two targeted therapies, TABRECTA and NERLYNX.
Bora Lim MD and Rachel Layman MD will serve as the co-principal investigators of this study while MD Anderson will be a sponsor. Puma will supply NERLYNX and Novartis will supply TABRECTA.
Both therapies currently approved by the U.S. Food and Drug Administration to treat non-small cell lung cancer and HER2-positive breast cancer, respectively.
Recent financial results
On February 16, 2021, Celcuity announced financial results for the fourth quarter and the year ended December 31, 2020.
Q4 2020 Financial highlights
- For the fourth quarter of 2020, Total operating expenses were $2.55 million, compared to $1.90 million for the fourth quarter of 2019.
- Research and development expenses were $2.11 million for the reported quarter of 2020, compared to $1.50 million for the fourth quarter of 2019.
- For the fourth quarter of 2020, general and administrative expenses were $0.44 million, compared to $0.40 million for the fourth quarter of 2019.
- CLC suffered a net loss of $2.55 million or $0.25 per share for the fourth quarter of 2020, compared to a net loss of $1.81 million, or $0.18 per share, for the fourth quarter of 2019.
- Non-GAAP adjusted net loss for the fourth quarter of 2020 was $2.12 million, or $0.21 per share, compared to a non-GAAP adjusted net loss of $1.45 million, or $0.14 per share, for the fourth quarter of 2019.
- CELC used $2.11 million net cash in operating activities for the fourth quarter of 2020, compared to $1.70 million for the fourth quarter of 2019.
FY 2020 highlights
- For FY 2020, CELC spent $9.56 million in operating expenses compared to $7.81 million for the fiscal year 2019.
- R&D expenses for the year 2020 were $7.68 million, compared to $6.27 million for the prior year.
- G&A expenses were $1.87 million for 2020, compared to $1.53 million for the fiscal year 2019.
- Celcuity suffered a net loss of $9.47 million or $0.92 per share for the fiscal year 2020, compared to $7.36 million, or $0.72 per share, for the fiscal year 2019.
- Non-GAAP adjusted net loss for the fiscal year 2020 was $7.71 million, or $0.75 per share, compared to a non-GAAP adjusted net loss of $6.32 million, or $0.62 per share, for the fiscal year 2019.
- Celcuity had cash and cash equivalents of $11.6 million on December 31, 2020, compared to cash and cash equivalents of $18.7 million on December 31, 2019.
The recent clinical trial data announcement and partnership with Pfizer is the reason behind its Friday pre-market surging. Both news came after the market closure on Thursday so now its stock is rising.