On May 7, 2020 Bellicum Pharmaceuticals, Inc. (NASDAQ:BLCM), a leader in developing novel, controllable cellular immunotherapies for cancers, reported financial results for the first quarter 2020 and provided an operational update (Press release, Bellicum Pharmaceuticals, MAY 7, 2020, View Source [SID1234557295]).
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"Bellicum entered the year with a renewed strategic focus on our novel GoCAR programs and we are pleased with the progress of our three development assets in the face of the COVID-19 pandemic," said Rick Fair, President and Chief Executive Officer of Bellicum. "Despite the public health challenges, we continued enrollment in our BPX-601 clinical trial, advanced our non-clinical research, and completed the strategically important sale of our facility to MD Anderson. Most importantly, we remain committed to the health and safety of our employees, our clinical collaborators, and patients involved in our clinical trials, and are closely monitoring and responding to public health guidance as we continue our important work."
PROGRAM HIGHLIGHTS AND CURRENT UPDATES
BPX-601 GoCAR-T
•Bellicum is currently enrolling patients in cohort 5C of the BPX-601 clinical trial in relapsed pancreatic cancer to evaluate the safety of repeat rimiducid dosing to re-activate BPX-601 cells over time. This is the first-in-human experience using the GoCAR platform as intended. Initial results from Cohort 5C are expected to be presented at a medical meeting by the end of 2020. Bellicum presented new Phase 1 translational data for BPX-601 at the American Society of Clinical Oncology (ASCO) (Free ASCO Whitepaper) Gastrointestinal Cancers Symposium (ASCO GI) in San Francisco in January 2020. Primary observations included tumor infiltration, GoCAR-T mediated immunomodulation, survival and persistence of cells for up to nine months, and changes in the tumor microenvironment gene expression consistent with a productive CAR-T cell immune response.
BPX-603 GoCAR-T
•Bellicum continues to conduct its investigational work in preparation of its response to the FDA’s request to further characterize this product candidate and support potential IND clearance. Management expects to provide an update on its progress for this program in the third quarter of 2020.
BCMA GoCAR-NK Program
•Preclinical development activities are continuing for Bellicum’s GoCAR-NK program targeting B-cell maturation antigen, or BCMA, for the treatment of multiple myeloma. Allogeneic GoCAR-NK cells may improve the durability of clinical responses while offering the anticipated advantages that an off-the-shelf product may provide, including faster and more certain time to treatment, greater scalability and convenience, and potentially lower cost. Management expects to present additional preclinical data for this program by the end of 2020.
Exhibit 99.1
Corporate Highlights
•In April 2020, Bellicum closed a transaction in which The University of Texas MD Anderson Cancer Center acquired Bellicum’s approximately 60,000-square-foot Houston facility, including manufacturing, office and laboratory space, for $15.0 million. In conjunction with the asset purchase agreement, Bellicum entered into a master services agreement with MD Anderson under which MD Anderson will manufacture Bellicum’s cellular therapy candidates, in addition to using the facility for its own internal programs. Concurrent with this transaction, Bellicum partially repaid approximately $7.0 million of its Oxford Finance debt obligations.
Potential for COVID-19 Impact
•Due to the COVID-19 pandemic, MD Anderson has temporarily closed its cell therapy manufacturing facilities. Bellicum does not currently expect the facility closure to significantly impact the company’s clinical trial progression and the timing of results, but such delays are possible depending on the duration of closure. The exact timing of potential delays and the overall impact of the COVID-19 pandemic on Bellicum’s business, its ability to obtain clinical material, and to conduct preclinical research and clinical trials in a timely manner is currently unknown. So far, the pandemic has not had a material impact on Bellicum’s ability to conduct its business activities, but that could change, and management is monitoring and responding to the crisis as it continues to evolve.
First Quarter 2020 Financial Results
R&D Expenses: Research and development (R&D) expenses were $10.4 million for the first quarter of 2020, compared to $16.8 million for the first quarter of 2019. The reduction in expenses in the first quarter of 2020 resulted primarily from reduced expenses related to rivo-cel and the reduction in force that was implemented during the second half of 2019, partially offset by an increase in expenses related to our GoCAR programs.
G&A Expenses: General and administrative (G&A) expenses were $4.2 million for the first quarter of 2020 compared to $7.5 million during the comparable period in 2019. The reduction in expenses in the first quarter 2020 relative to the comparable period in 2019 were primarily due to the reduction in rivo-cel related commercialization activities as well as the effects of the reduction in force that reduced employee-related charges.
Loss from Operations: Bellicum reported a loss from operations of $14.6 million for the first quarter of 2020 compared to a loss from operations of $23.9 million for the first quarter of 2019. Cash used in operating activities was $16.3 million for the first quarter of 2020, compared to cash used in operating activities of $24.6 million.
Net Income/Loss: Bellicum reported net income of $17.6 million for the first quarter of 2020 compared to a net loss of $24.5 million for the first quarter of 2019. The results included a non-cash gain of $32.8 million related to the change in fair value of warrant and private placement option liability in the first quarter of 2020.
Shares Outstanding: As of March 31, 2020, Bellicum had 5,049,892 shares of common stock outstanding and 534,000 shares of preferred stock outstanding. Each share of preferred stock can be converted into 10 shares of common stock.
Cash Position and Guidance: Bellicum reported cash and cash equivalents and restricted cash totaling $75.5 million as of March 31, 2020, compared to $93.8 million as of December 31, 2019. Based on current operating plans, Bellicum expects that current cash resources will be sufficient to meet operating requirements into the second half of 2021. Management expects cash utilization of $55 to $65 million in 2020.