 Received FDA IND clearance to initiate Phase 12 clinical trial for BPX-603 for HER2 solid tumors Initial data for BPX-601 cohort 5C to be presented at a medical meeting by the end of 2020Management to host conference call and webcast today at 5 p.m. ET 2 p.m. PTHOUSTON, Aug. 06, 2020 GLOBE NEWSWIRE -- Bellicum Pharmaceuticals, Inc. NASDAQ: BLCM, a leader in developing novel, controllable cellular immunotherapies for cancers, today reported financial results for the second quarter 2020 and provided an operational update.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 UpdatesBPX-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 1x107 cellskg; 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 companys first dual-switch GoCAR-T product candidate, which incorporates both the companys iMC activation and CaspaCIDe safety switch technologies and the company plans to initiate a Phase 12 basket trial in solid tumors that express HER2 later this year.BCMA GoCAR-NKTM Program In May 2020, preclinical data from Bellicums GoCAR-NK cell program was published in the digital edition of Blood Advances, a journal published by The American Society of Hematology, 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 Bellicums 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 Bellicums 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 ResultsRD Expenses: Research and development RD 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.GA Expenses: General and administrative GA 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 MilestonesBelow is a summary of notable anticipated milestones for our ongoing programs: BPX-601 Initial Phase 1 cohort 5C data repeat rimiducid pancreatic cancer: Q420 Phase 12 data update pancreatic cancer: 2H21 Initial Phase 12 data prostate cancer: 2022 BPX-603 Initiate Phase 12 trial: 2H20 Initial Phase 1 data: 2H21 Phase 1 data update: 2022 BCMA GoCAR-NK Preclinical data update: Q420 Preclinical data update: 2H21 IND clearance: 2022Conference Call and WebcastBellicums 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 companys website at and a replay will be available shortly after the live event.About Bellicum PharmaceuticalsBellicum is a clinical stage biopharmaceutical company striving to deliver cures through controllable cell therapies. The companys next-generation product candidates are differentiated by powerful cell signaling technologies designed to produce more effective CAR-T and CAR-NK cell therapies. Bellicums GoCAR-T product candidates, BPX-601 and BPX-603, are designed to be more efficacious CAR-T cell products capable of overriding key immune inhibitory mechanisms. More information about Bellicum can be found at StatementsThis press release contains forward-looking statements for purposes of the safe harbor provisions of the Private Securities Litigation Reform Act of 1995. Bellicum may, in some cases, use terms such as predicts, believes, potential, proposed, continue, designed, estimates, anticipates, expects, plans, intends, may, could, might, will, should or other words that convey uncertainty of future events or outcomes to identify these forward-looking statements. Forward-looking statements include statements regarding our intentions, beliefs, projections, outlook, analyses or current expectations concerning, among other things: our research and development activities and expectations regarding presenting data for our BPX-601, BPX-603, GoCAR-NK and other cell therapy programs, our ability to enroll patients and generate meaningful clinical data in our ongoing GoCAR clinical programs; whether we will be able to amend the ongoing BPX-601 protocol to treat additional patient populations including patients with prostate cancer; our ability to initiate a clinical trial in BPX-603, including site selection and start-up; our ability to make additional progress on the nonclinical development of the BCMA-GoCAR-NK candidate; the potential impact of the COVID-19 on enrollment in clinical trials and other aspects of our business; our expected cash runway; and the anticipated milestones identified above. 