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HOUSTON, March 12, 2019 (GLOBE NEWSWIRE) -- Bellicum Pharmaceuticals, Inc. (NASDAQ:BLCM), a leader in developing novel, controllable cellular immunotherapies for cancers and orphan inherited blood disorders, today reported financial results for the fourth quarter and full year ended December 31, 2018.
“We believe that Bellicum is well-positioned for an exciting and eventful 2019 as a result of our investments to strengthen our clinical development and executive teams over the past 24 months,” said Bellicum’s President & CEO Rick Fair. “Based on promising preclinical and initial clinical data on BPX-601, we have prioritized GoCAR-T® candidates incorporating our iMC activation switch in our clinical development strategy. In addition to progressing our Phase 1/2 trial of BPX-601, we intend to submit IND applications for two novel, dual-switch GoCAR-T clinical programs in 2019. For rivo-cel™, we anticipate topline Phase 2 results in pediatric patients in the second quarter of 2019, which will form the basis for European Marketing Authorisation Application (MAA) submissions planned for late 2019.”
PROGRAM HIGHLIGHTS AND CURRENT UPDATES
Bellicum Advances and Expands Clinical Program for GoCAR-T Platform
Controllable Dual-Switch Candidates
Company Prepares for Rivo-cel Registration in E.U. for Pediatric Patients and Initiates Global Trial for Adult and Adolescent Patients
Company Makes Key Additions to Management Team and Board of Directors; Forms Scientific and Clinical Advisory Board
Fourth Quarter and Full Year 2018 Financial Results
Cash Position and Guidance: Bellicum reported cash, restricted cash and investments totaling $98.0 million as of December 31, 2018, compared to $106.5 million at December 31, 2017. Based on current operating plans, Bellicum expects that current cash resources will be sufficient to meet operating requirements through the end of 2019.
R&D Expenses: Research and development expenses were $19.8 million and $71.2 million for the fourth quarter and year ended December 31, 2018, respectively, compared to $14.3 million and $65.7 million during the comparable periods in 2017. The higher expenses in the fourth quarter and full year 2018 compared to respective periods in 2017 were primarily due to an increase in costs related to Bellicum's GoCAR-T product platform and general research and development expenses, partially offset by a decrease in expenditures related to rivo-cel.
G&A Expenses: General and administrative expenses were $7.0 million and $25.0 million for the fourth quarter and year ended December 31, 2018, respectively, compared to $5.1 million and $21.0 million during the comparable periods in 2017. The higher expenses in the fourth quarter and full year 2018 compared to respective periods in 2017 were primarily due to increased personnel related costs due to hiring additional employees.
Net Loss: Bellicum reported a net loss of $27.2 million for the fourth quarter of 2018 and $98.0 million for the year ended December 31, 2018, compared to a net loss of $21.9 million and $91.8 million for the comparable periods in 2017. The results included non-cash, share-based compensation charges of $3.0 million and $13.8 million for the fourth quarter and year ended December 31, 2018, respectively, and $3.4 million and $13.6 million for the comparable periods in 2017.
At December 31, 2018, Bellicum had 43,564,596 shares of common stock outstanding.
Upcoming Near-term Potential Milestones
Conference Call and Webcast
Bellicum management will host a webcast and conference call at 5:00 p.m. Eastern today to discuss the financial results. To access the call, participants should dial 877-407-3103 (U.S. domestic) and 201-493-6791 (international) at least 10 minutes prior to the start of the call. The event will be webcast live and can also be accessed in the Investors & Media section of bellicum.com. An archived version of the webcast will also be available for replay in the Investors & Media section of the Bellicum website following the call.
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.
About Rivo-cel (BPX-501)
Rivo-cel™ (rivogenlecleucel) is an allogeneic polyclonal T-cell product designed to accelerate immune recovery after HSCT and to reduce relapse of leukemia following a stem cell transplant. The cell treatment contains a diverse repertoire of T cells which may contribute to a robust graft vs. leukemia effect. Rivo-cel’s anti-infective benefits may also reduce morbidity and mortality, as patients are highly susceptible to infection following a transplant. The product’s CaspaCIDe® safety switch enables this approach by allowing physicians to reduce the number of alloreactive cells in the event of uncontrolled GvHD. Rivo-cel addresses a major unmet need in adult and pediatric leukemia, lymphoma and inherited blood disease patients following a haploidentical stem cell transplant.
About Bellicum Pharmaceuticals
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 T 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. Bellicum’s rivo-cel product candidate is an allogeneic polyclonal T cell therapy that has shown promising clinical trial results in reducing leukemia relapse after a stem cell transplant. 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, rimiducid, BPX-601, BPX-603, BPX-802, and other cell therapy programs; our pipeline candidates’ effectiveness, possible ranges of application and potential safety and curative effects in the treatment of diseases, including as compared to other treatment options and competitive therapies; 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 expansion of or changes to our ongoing clinical trials to new indications and diseases; the timing and success of regulatory filings for rivo-cel and rimiducid including our planned European Marketing Authorisation Applications (MAA); the speed and effectiveness of our preparations for potential commercialization in Europe if the MAAs are approved; the impact of our efforts to strengthen our clinical development and executive teams; and our cash uses and 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 Securities and Exchange Commission, including without limitation our annual report on Form 10-K the year ended December 31, 2018. Any forward-looking statements that Bellicum makes in this press release speak only as of the date of this press release. Bellicum assumes no obligation to update our forward-looking statements whether as a result of new information, future events or otherwise, after the date of this press release.
|BELLICUM PHARMACEUTICALS, INC.|
|Audited Consolidated Condensed Balance Sheets|
|December 31,||December 31,|
|Cash and cash equivalents||$||43,695||$||38,839|
|Investment securities, available-for-sale, short-term||49,304||60,057|
|Receivables and other current assets||2,296||2,754|
|Investment securities, available-for-sale, long-term||-||1,368|
|Property and equipment, net||20,878||25,942|
|Other assets, net||355||378|
|Accounts payable and other accrued liabilities||$||12,363||$||9,679|
|Other current liabilities||3,441||2,477|
|Other liabilities, net of current portion||37,219||38,724|
|Total Stockholders' Equity||68,478||84,648|
|Total Liabilities and Stockholders' Equity||$||121,501||$||135,528|
|BELLICUM PHARMACEUTICALS, INC.|
|Audited Consolidated Condensed Statements of Operations|
|(in thousands, except share and per share amounts)|
|Three Months Ended||Year Ended|
|December 31,||December 31,|
|Research and development||19,791||14,308||71,152||65,663|
|General and administrative||6,971||5,053||24,998||21,045|
|Total operating expenses||26,879||19,376||96,586||87,572|
|Interest and other income (expense), net||(653||)||(687||)||(2,570||)||(2,606||)|
|Loss on extinguishment of debt||-||(1,786||)||-||(1,786||)|
|Net loss attributable to common shareholders||$||(27,220||)||$||(21,918||)||$||(98,036||)||$||(91,779||)|
|Net loss per share attributable to common|
|shareholders, basic and diluted||$||(0.63||)||$||(0.66||)||$||(2.44||)||$||(2.89||)|
|Weighted average common shares outstanding, basic and diluted||43,382,010||33,226,475||40,230,580||31,714,164|
Source: Bellicum Pharmaceuticals
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