Bellicum Reports Fourth Quarter and Full Year 2019 Financial Results and Provides Operational Update
Presented new Phase 1 translational results for BPX-601 at ASCO GI
Initiated new GoCAR-NK™ program targeting BCMA
Entered into asset purchase agreement and licensed technology to MD
“Bellicum is at an exciting inflection point as we continue to validate the GoCAR™ platform and explore its utility more broadly,” said
PROGRAM HIGHLIGHTS AND CURRENT UPDATES
- Bellicum presented new Phase 1 translational data for BPX-601 at the
American Society of Clinical Oncology Gastrointestinal Cancers Symposium(ASCO GI) in San Franciscoin 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.
Bellicum is currently enrolling cohort 5C of this trial to collect data to evaluate the safety of repeat rimiducid dosing to re-activate GoCAR-T cells over time, 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.
- In response to Bellicum’s IND application for BPX-603, the FDA requested additional nonclinical data to further characterize this product candidate. Non-clinical experiments to generate the data are underway. Management expects to provide an update on its progress for this program in the third quarter of 2020.
BCMA GoCAR-NK Program
- Bellicum recently initiated formal preclinical development activities for its GoCAR-NK program targeting B-cell maturation antigen, or BCMA, for the treatment of multiple myeloma. Bellicum presented a poster at the
Society for Immunotherapy of Cancer(SITC) Annual Meeting in November 2019that included preclinical data that suggest the GoCAR platform may enhance NK cell proliferation, persistence, and cytotoxicity, potentially improving their utility as an off-the-shelf cancer therapy. Specifically, Bellicum believes that GoCAR-NK may improve the durability of clinical responses while offering the anticipated advantages that an allogeneic, 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.
January 2020, Bellicum entered into an asset purchase agreement under which The University of Texas MD Anderson Cancer Centerwill acquire Bellicum’s approximately 60,000-square-foot Houstonfacility, including manufacturing, office and laboratory space, for $15.0 million. As part of the transaction, Bellicum will also enter into a master services agreement with MD Anderson. Following completion of the transaction, MD Andersonwill operate the Houstonfacility for its own internal programs as well as to manufacture Bellicum’s GoCAR™ and other cellular therapy programs for clinical trials and potentially early commercial supply.
December 2019, Bellicum licensed its CaspaCIDe® safety switch to MD Andersonfor use in its CD19 CAR-NK program. Under terms of the original license agreement, MD Andersonexercised its option to non-exclusively license the technology for this construct and subsequently sublicensed it to a third party for future development. These actions entitled Bellicum to receive an upfront payment of $5 millionand undisclosed future milestone payments and royalties on sales.
Fourth Quarter and Full Year 2019 Financial Results and Outlook
Revenue: Bellicum reported revenue of
R&D Expenses: Research and development expenses were
G&A Expenses: General and administrative expenses were
Loss from Operations: Bellicum reported a loss from operations of
Cash used in operating activities was
Net Loss: Bellicum reported a net loss of
Shares Outstanding: In February, Bellicum effected a reverse stock split of its issued and outstanding common stock, at a ratio of 1-for-10. As of
Cash Position and Guidance: 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
Conference Call and Webcast
Bellicum’s management will host a webcast and conference call today at
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 CAR-NK 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 about Bellicum 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: statements regarding 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 program and advance additional GoCAR programs to the clinic; the ability and timing of generating the nonclinical data necessary to secure FDA clearance of the IND submitted for BPX-603; and our expected cash runway. Various factors may cause differences between Bellicum’s expectations and actual results as discussed in greater detail under the heading “Risk Factors” in Bellicum’s filings with the
|Consolidated Balance Sheets|
|(unaudited; in thousands)|
|Cash and cash equivalents||$||91,028||$||43,695|
|Restricted cash, current||2,788||—|
|Investment securities, available-for-sale||—||49,304|
|Accounts receivable, interest and other receivables||303||909|
|Prepaid expenses and other current assets||884||1,387|
|Assets held for sale||16,851||—|
|Operating lease right-of-use assets||1,042||—|
|Property and equipment, net||2,529||20,878|
|Restricted cash, noncurrent||—||4,973|
|Accrued expenses and other current liabilities||9,770||8,589|
|Warrant derivative liability||52,184||—|
|Private placement option liability||12,094||—|
|Current portion of long-term debt||11,000||—|
|Current portion of lease liabilities||454||40|
|Current portion of deferred revenue||—||2,983|
|Current portion of deferred rent||—||418|
|Liabilities held for sale||6,273||—|
|Long-term debt, net of deferred issuance costs||25,717||35,832|
|Long-term lease liabilities||864||91|
|Total stockholders' (deficit) equity||(26,217||)||68,478|
|Total liabilities, preferred stock and stockholders' (deficit) equity||$||116,250||$||121,501|
|Consolidated Statements of Operations|
|(unaudited; in thousands, except share and per share amounts)|
|Three Months Ended||Year Ended|
|License fee revenue||5,000||—||5,000||—|
|Research and development||13,324||19,908||64,535||71,588|
|General and administrative||5,709||6,971||29,972||24,998|
|Total operating expenses||19,033||26,879||94,507||96,586|
|Interest expense, net of interest income||(736||)||(643||)||(2,929||)||(2,560||)|
|Change in fair value of warrant liability||(14,342||)||—||(19,192||)||—|
|Net loss per share attributable to common shareholders, basic and diluted||$||(5.82||)||$||(6.27||)||$||(24.01||)||$||(24.37||)|
|Weighted-average shares outstanding, basic and diluted||4,981,803||4,338,201||4,684,711||4,023,058|
Senior Vice President
Source: Bellicum Pharmaceuticals, Inc.