On November 6, 2019 Bellicum Pharmaceuticals, Inc. (NASDAQ:BLCM), a leader in developing novel, controllable cellular immunotherapies for cancers, reported financial results for the third quarter 2019 and provided an operational update (Press release, Bellicum Pharmaceuticals, NOV 6, 2019, View Source [SID1234550444]).

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"Bellicum made significant strides in the third quarter repositioning the company to focus exclusively on our GoCAR programs, as we seek to clinically demonstrate how our technology may extend the impact of CAR-T therapies to more patients," said Rick Fair, President and Chief Executive Officer of Bellicum Pharmaceuticals. "By streamlining the organization and other cost-saving initiatives and executing a financing in August, we believe we have positioned the company to generate meaningful clinical data on our ongoing GoCAR programs and to advance a third GoCAR program toward the clinic."

PROGRAM HIGHLIGHTS AND CURRENT UPDATES

BPX-601 GoCAR-T

Bellicum anticipates presenting new translational data from cohort 5B in the BPX-601 Phase 1/2 trial in early 2020. These data are expected to provide additional evidence on the proposed mechanisms of action of iMC activation in BPX-601, including cell expansion and persistence, cytokine production, tumor infiltration, and CAR-T activity in the tumor microenvironment. Bellicum is currently enrolling cohort 5C. Data from this cohort will be used to evaluate the safety of repeat rimiducid dosing to re-activate iMC over time, which is intended to deepen and extend the treatment effect. Patient enrollment has proceeded more slowly than anticipated primarily as the result of the amended protocol limiting enrollment to second line patients. Initial results from Cohort 5C are expected to be presented in the second half of 2020.
BPX-603 GoCAR-T

In response to Bellicum’s IND application for BPX-603, the FDA has responded with a request for additional preclinical data to better characterize the potential risk of off-tumor / on-target toxicity before IND clearance. Bellicum is engaged in discussions with the FDA to align on a plan to address the request.
Research Programs

An abstract for a preclinical investigation from Bellicum’s natural killer cell GoCAR program has been accepted for poster presentation at the Society for Immunotherapy of Cancer (SITC) (Free SITC Whitepaper) Annual Meeting on November 8, 2019.
Rivo-cel

Bellicum is actively pursuing a strategic partner for rivo-cel to lead future development and commercialization for this product candidate. Bellicum has reduced and expects to continue to reduce its rivo-cel related activities.
Corporate Highlights

In August, Bellicum announced receipt of aggregate gross proceeds of $69.6 million, including gross proceeds of $57.5 million from an underwritten public offering and a $12.1 million private placement option fee related to its private placement of up to $70 million in additional potential gross proceeds.
Bellicum is actively pursuing a partner to purchase its manufacturing facility and establish a preferred supply agreement with the goal of reducing operating costs while maintaining viral vector and cell therapy development capabilities and dedicated manufacturing capacity for its programs.
Third Quarter 2019 Financial Results and Outlook

R&D Expenses: Research and development (R&D) expenses were $14.3 million for the third quarter of 2019, compared to $16.4 million for the third quarter of 2018. The reduction in expenses in the third quarter of 2019 resulted primarily from reduced expenses related to rivo-cel and reduced general R&D expenses, partially offset by higher expenditures related to the GoCAR-T platform. R&D expenses for the nine months ended September 30, 2019 were $51.0 million compared to $51.4 million for the comparable period in the prior year.

G&A Expenses: General and administrative (G&A) expenses were $9.2 million for the third quarter of 2019 compared to $7.0 million during the comparable period in 2018. The higher expenses in the third quarter 2019 relative to the comparable period in 2018 were primarily due to an accrual of severance costs arising from reductions in rivo-cel related activities. G&A expenses for the nine months ended September 30, 2019 were $24.3 million compared to $18.0 million for the first nine months of 2018.

Net Loss: Bellicum reported a net loss of $32.0 million for the third quarter of 2019 compared to a net loss of $23.8 million for the third quarter of 2018. The results included non-cash, share-based compensation charges of $1.6 million and $3.7 million for the third quarter of 2019 and 2018, respectively. Net loss for the nine months ended September 30, 2019 was $83.5 million compared to a loss of $70.8 million for the nine months ended September 30, 2018.

Shares Outstanding: At October 31, 2019, Bellicum had 49,616,316 shares of common stock outstanding and 541,500 shares of preferred stock outstanding. Each preferred share can be converted into 100 shares of common stock.

Cash Position and Guidance: Bellicum reported cash, restricted cash and investments totaling $106.9 million as of September 30, 2019, compared to $98.0 million at December 31, 2018. Based on current operating plans, Bellicum expects that current cash resources will be sufficient to meet operating requirements into 2021.

Conference Call and Webcast

Bellicum’s management will host a webcast and conference call today at 5 p.m. ET / 2 p.m. PT, November 6, 2019, to discuss the financial results for the third quarter 2019 and provide a corporate update. The live call may be accessed by dialing (877) 407-3103 for domestic callers and (201) 493-6791 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.

About BPX-601

BPX-601, the company’s first GoCAR-T product candidate, incorporates iMC, Bellicum’s inducible co-activation domain. iMC (inducible MyD88/CD40) is designed to provide a powerful boost to T cell proliferation and persistence and enable the CAR-T to override key immune inhibitory mechanisms, including PD-1 and TGF-beta. BPX-601 is being evaluated as a treatment for solid tumors expressing prostate stem cell antigen (PSCA), including pancreatic, gastric, and prostate cancers.