On August 6, 2020 Bellicum Pharmaceuticals, Inc. (NASDAQ: BLCM), a leader in developing novel, controllable cellular immunotherapies for cancers, reported financial results for the second quarter 2020 and provided an operational update (Press release, Bellicum Pharmaceuticals, AUG 6, 2020, View Source [SID1234563091]).

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"Bellicum continued to make significant progress in the second quarter, highlighted by FDA clearance of our IND for BPX-603, our first dual-switch Go-CAR-T product candidate to enter clinical development," said Rick Fair, President and Chief Executive Officer of Bellicum. "We expect to be entering a period of accelerated news flow for our company with multiple data readouts planned in the next 24 months, starting in the fourth quarter with our initial presentation of the BPX-601 Phase 1 cohort 5C with repeat rimiducid."
Program Highlights and Current Updates

BPX-601 GoCAR-T
•Bellicum continues to enroll patients in cohort 5C of the BPX-601 clinical trial in second-line metastatic pancreatic cancer to evaluate the safety of repeat rimiducid dosing to re-activate BPX-601 cells over time. Bellicum plans to present interim results for this cohort at a medical meeting by the end of the year. The study has experienced modest enrollment delays and data collection issues related to the COVID-19 pandemic which may impact the number of patients, duration of follow-up and data to be presented.

•In addition, Bellicum has submitted an amendment to the FDA to modify the BPX-601 trial by: (1) expanding eligibility to third-line pancreatic cancer patients; (2) extending dose escalation of BPX-601 cells to 1×107 cells/kg; and (3) opening a cohort in relapsed metastatic castration-resistant prostate cancer. The company expects to begin enrolling under this amended protocol later this year.

BPX-603 GoCAR-T
•In June 2020, Bellicum received clearance from the U.S. Food and Drug Administration (FDA) of its investigational new drug application (IND) for BPX-603. BPX-603 is a GoCAR-T product candidate targeting solid tumors that express human epidermal growth factor receptor 2 (HER2). BPX-603 is the company’s first dual-switch GoCAR-T product candidate, which incorporates both the company’s iMC activation and CaspaCIDe safety switch technologies and the company plans to initiate a Phase 1/2 basket trial in solid tumors that express HER2 later this year.

BCMA GoCAR-NK Program
•In May 2020, preclinical data from Bellicum’s GoCAR-NK cell program was published in the digital edition of Blood Advances, a journal published by The American Society of Hematology (ASH) (Free ASH Whitepaper), illustrating that the incorporation of iMC into CAR-NK cells was found to improve cell proliferation and persistence, stimulate cytokine production, and enhance innate cytotoxicity against tumor cells in multiple models. Preclinical development activities are continuing for Bellicum’s GoCAR-NK program targeting B-cell maturation antigen, or BCMA, for the treatment of multiple myeloma. Management expects to present additional preclinical data for this program by the end of 2020.

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. Concurrent with this transaction, Bellicum partially repaid approximately $7.0 million of its Oxford Finance debt obligations.

Second Quarter 2020 Financial Results
R&D Expenses: Research and development (R&D) expenses were $11.8 million and $22.2 million for the three and six months ended June 30, 2020, respectively, compared to $20.0 million and $36.9 million for the three and six months ended June 30, 2019, respectively. The reduction in expenses in the second quarter and first half of 2020 resulted primarily from reduced expenses related to reduced rivo-cel related activities, reduced expenses resulting from the manufacturing facility sale and the reduction in force implemented during the second half of 2019, partially offset by an increase in expenses related to the GoCARTM programs.

G&A Expenses: General and administrative (G&A) expenses were $3.8 million and $7.9 million for the three and six months ended June 30, 2020, respectively, compared to $7.5 million and $15.1 million for the three and six months ended June 30, 2019, respectively. The reduction in expenses during the second quarter and first half of 2020 relative to the comparable period in 2019 was 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 $11.8 million and $26.4 million for the three and six months ended June 30, 2020, respectively, compared to a loss from operations of $26.2 million and $50.0 million for the three and six months ended June 30, 2019, respectively. The results for the three and six months ended June 30, 2020 included a net gain on dispositions of $3.8 million due to the manufacturing facility sale. Cash used in operating activities was $30.5 million for the six months ended June 30, 2020, compared to cash used in operating activities of $46.0 million for the six months ended June 30, 2019.

Net Loss: Bellicum reported net loss of $43.2 million and $25.6 million for the three and six months ended June 30, 2020, respectively, compared to a net loss of $26.9 million and $51.5 million for the three and six months ended June 30, 2019, respectively. The results included a non-cash loss of $30.7 million and non-cash gain of $2.1 million related to the change in fair value of warrant and private placement option liability for the three and six months ended June 30, 2020, respectively.
Shares Outstanding: As of June 30, 2020, Bellicum had 5,059,779 shares of common stock 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 $68.0 million as of June 30, 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.

Potential Milestones

Below is a summary of notable anticipated milestones for our ongoing programs:

BPX-601
•Initial Phase 1 cohort 5C data (repeat rimiducid) – pancreatic cancer: Q4’20
•Phase 1/2 data update – pancreatic cancer: 2H’21
•Initial Phase 1/2 data – prostate cancer: 2022

BPX-603
•Initiate Phase 1/2 trial: 2H’20
•Initial Phase 1 data: 2H’21
•Phase 1 data update: 2022

BCMA GoCAR-NK
•Preclinical data update: Q4’20
•Preclinical data update: 2H’21
•IND clearance: 2022

Conference Call and Webcast

Bellicum’s management will host a webcast and conference call today at 5 p.m. ET / 2 p.m. PT, August 6, 2020, to discuss the financial results for the second quarter 2020 and provide a corporate update. The live call may be accessed by dialing (800) 920-0677 for domestic callers and (212) 231-2908 for international callers. A live webcast of the call will be available from the Investors and Media section of the company’s website at www.bellicum.com and a replay will be available shortly after the live event.