Bellicum Pharmaceuticals Reports Third Quarter 2019 Financial Results and Provides Operational Update
Raised gross proceeds of
Narrowed strategic focus to core GoCAR-T® cell therapy programs
Cost saving initiatives underway to extend runway to meaningful GoCAR data readouts
“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
PROGRAM HIGHLIGHTS AND CURRENT UPDATES
- 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.
- In response to Bellicum’s IND application for BPX-603, the
FDAhas 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 FDAto align on a plan to address the request.
- 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) Annual Meeting on November 8, 2019.
- 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.
- In August, Bellicum announced receipt of aggregate gross proceeds of
$69.6 million, including gross proceeds of $57.5 millionfrom an underwritten public offering and a $12.1 millionprivate placement option fee related to its private placement of up to $70 millionin 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
G&A Expenses: General and administrative (G&A) expenses were
Net Loss: Bellicum reported a net loss of
Shares Outstanding: At
Cash Position and Guidance: Bellicum reported cash, restricted cash and investments totaling
Conference Call and Webcast
Bellicum’s management will host a webcast and conference call today at
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.
Bellicum is a clinical stage biopharmaceutical company striving to deliver cures through controllable cell therapies. The company’s next-generation product candidates are differentiated by powerful cell signaling technologies designed to produce more effective CAR-T and allogeneic cell therapies. Bellicum’s lead GoCAR-T® candidate, BPX-601, is designed to be a more efficacious CAR-T cell product capable of overriding key immune inhibitory mechanisms. More information can be found at www.bellicum.com.
This 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 relating to rivo-cel, BPX-601, BPX-603, and our other cell therapy programs; the timing and success of our current and planned clinical trials, including the timing of receipt of data from such clinical trials and the timing of our reports of such data; the impact of recent initiatives and business developments on our positioning to provide meaningful clinical data on our ongoing GoCAR programs and advance a third GoCAR program to the clinic; our expectations regarding additional reductions in BPX-501-related activities; our plans regarding interactions with the
|BELLICUM PHARMACEUTICALS, INC.|
|Unaudited Condensed Consolidated Balance Sheets|
|September 30,||December 31,|
|Cash and cash equivalents||$||99,151||$||43,695|
|Investment securities, available-for-sale, short-term||4,152||49,304|
|Receivables and other current assets||1,562||2,296|
|Property and equipment, net||16,204||20,878|
|Accounts payable and other accrued liabilities||15,663||12,363|
|Private placement option liability||12,094||-|
|Current maturities of long-term debt||8,000||-|
|Other current liabilities||2,839||3,441|
|Other liabilities, net of current portion||6,163||1,387|
|Total Stockholders' Equity||1,229||68,478|
|Total liabilities and stockholders' equity||$||133,932||$||121,501|
|BELLICUM PHARMACEUTICALS, INC.|
|Unaudited Condensed Consolidated Statements of Operations|
|(in thousands, except share and per share amounts)|
|Three Months Ended||Nine Months Ended|
|September 30,||September 30,|
|Research and development||14,331||16,413||51,008||51,361|
|General and administrative||9,209||6,968||24,263||18,027|
|Total operating expenses||23,540||23,520||75,474||69,707|
|Change in fair value of warrant liability||(4,850||)||-||-||(4,850||)||-|
|Interest expense, net of interest income||(756||)||(573||)||(2,193||)||(1,917||)|
|Net loss attributable to common shareholders||$||(32,032||)||$||(23,801||)||$||(83,496||)||$||(70,816||)|
|Net loss per share attributable to common shareholders, basic and diluted||$||(0.68||)||$||(0.55||)||$||(1.82||)||$||(1.81||)|
|Weighted-average common shares outstanding, basic and diluted||47,208,958||43,334,727||45,845,928||39,168,559|
Senior Vice President
Source: Bellicum Pharmaceuticals, Inc.