On May 17, 2021 Bellicum Pharmaceuticals, Inc. (Nasdaq: BLCM), a leader in developing novel, controllable cellular immunotherapies for cancers, reported financial results for the first quarter 2021 and provided an operational update (Press release, Bellicum Pharmaceuticals, MAY 17, 2021, View Source [SID1234580112]).
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"In the first quarter, Bellicum maintained focus on the clinical studies of our next generation CAR-T cell therapies," said Rick Fair, President and Chief Executive Officer. "Our trials of BPX-601 in prostate cancer and BPX-603 in HER2+ solid tumors are well underway, and we look forward to providing future updates on our clinical progress for both programs."
Program Highlights and Current Updates
BPX-601 GoCAR-T
Patient enrollment is ongoing in the Phase 1/2 dose-escalation clinical trial evaluating BPX-601 and rimiducid in patients with previously treated metastatic pancreatic or prostate cancer.
Bellicum plans to present a Phase 1 data update on BPX-601 and rimiducid in patients with metastatic castration-resistant prostate cancer in the first quarter of 2022.
BPX-603 GoCAR-T
Bellicum is conducting its Phase 1/2 clinical trial for BPX-603 in patients with solid tumors that express human epidermal growth factor 2 (HER2), including breast, endometrial, ovarian, gastric, and colorectal cancers. BPX-603 is the company’s first dual-switch GoCAR-T product candidate, which incorporates Bellicum’s iMC activation and CaspaCIDe safety switch technologies. The company expects to present initial Phase 1 data from this trial in the fourth quarter of 2021.
CaspaCIDe
As announced in February, the first reported use of the CaspaCIDe safety switch to mitigate CAR-T cell toxicity was published as an ahead-of-print publication in the digital edition of Blood, a journal published by The American Society of Hematology (ASH) (Free ASH Whitepaper). The report described a case from an investigator-sponsored trial at the University of North Carolina Lineberger Comprehensive Cancer Center of autologous CAR-T cells expressing CD19 and CaspaCIDe. In this patient, grade 3-4 immune effector cell-associated neurotoxicity syndrome (ICANS) refractory to standard therapies was treated with rimiducid to activate CaspaCIDe. Within 12 hours of rimiducid administration, ICANS grade improved from 3 to 1 and was fully resolved after four days.
First Quarter 2021 Financial Results
R&D Expenses: Research and development expenses were $6.5 million for the first quarter of 2021 compared to $10.4 million during the first quarter of 2020. The reduction in expenses in the first quarter 2021 resulted primarily from reduced rivo-cel activities and the corporate restructuring implemented during the fourth quarter of 2020, partially offset by an increase in expenses related to the GoCAR programs.
G&A Expenses: General and administrative expenses were $2.0 million in the first quarter of 2021 compared to $4.2 million in the period a year ago. The reduction in expenses during the first quarter 2021 relative to the comparable period in 2020 was primarily due to the effects of the corporate restructuring that reduced employee-related charges.
Loss from Operations: Bellicum reported a loss from operations of $8.9 million for the first quarter of 2021 compared to a loss from operations of $14.6 million for the comparable period in 2020.
Net Income/Loss: Bellicum reported a net loss of $11.3 million for the first quarter of 2021 compared to net income of $17.6 million for the comparable period in 2020. The results included a non-cash loss of $2.3 million related to the change in fair value of the warrant and private placement option liability for the first quarter of 2021.
Shares Outstanding: As of May 10, 2021, Bellicum had 8,397,803 shares of common stock and 452,000 shares of preferred stock outstanding. Each share of preferred stock is convertible into 10 shares of common stock.
Cash Position and Guidance: Bellicum reported cash and cash equivalents and restricted cash totaling $29.6 million as of March 31, 2021, compared to $37.0 million as of December 31, 2020. Based on current operating plans, Bellicum expects that current cash resources will be sufficient to meet operating requirements into the second quarter of 2022.