Delaware | 001-36783 | 20-1450200 | ||
(State or other jurisdiction of incorporation) | (Commission File Number) | (IRS Employer Identification No.) | ||
2130 W. Holcombe Blvd., Ste. 800 Houston, TX | 77030 | |||
(Address of principal executive offices) | (Zip Code) |
¨ | Written communications pursuant to Rule 425 under the Securities Act (17 CFR 230.425) |
¨ | Soliciting material pursuant to Rule 14a-12 under the Exchange Act (17 CFR 240.14a-12) |
¨ | Pre-commencement communications pursuant to Rule 14d-2(b) under the Exchange Act (17 CFR 240.14d-2(b)) |
¨ | Pre-commencement communications pursuant to Rule 13e-4(c) under the Exchange Act (17 CFR 240.13e-4(c)) |
Exhibit No. | Description | |
99.1 | Press Release dated August 8, 2016. |
Bellicum Pharmaceuticals, Inc. | ||||||
Dated: August 8, 2016 | By: | /s/ Alan A. Musso | ||||
Alan A. Musso | ||||||
Chief Financial Officer and Treasurer | ||||||
Principal Financial and Accounting Officer |
Exhibit No. | Description | |
99.1 | Press Release dated August 8, 2016. |
• | Received US and EU orphan drug designations for BPX-501 and rimiducid, and announced strategy to pursue EMA approval under exceptional circumstances based on expanded BP-004 trial. Bellicum has met with regulatory authorities in Europe to discuss the potential approval pathway for BPX-501 and for rimiducid for the treatment of immunodeficiency and GvHD following a haploidentical HSCT in pediatric patients with leukemias, lymphomas and rare inherited blood diseases who do not have a matched donor. Based on these regulatory discussions, Bellicum believes that data from the European arm of its BP-004 trial, with a six-month follow-up time and expanded to enroll additional patients, could form the basis of Marketing Authorization Applications for BPX-501 and rimiducid. In place of a randomized trial, the Company intends to collect data from a concurrent observational study of allogeneic HSCT outcomes in the pediatric setting. Details will be further refined in a formal protocol assistance process. |
• | Reported new interim data from BP-004 trial in an oral presentation at the 42nd Annual Meeting of the European Society for Blood and Marrow Transplantation in April. Results demonstrated disease-free outcomes, reduced treatment-related mortality, reduced infection rates, faster immune reconstitution, and significant reductions in time-to-hospital discharge and re-hospitalizations, compared to historical controls. The Company expects to provide updated data by the end of 2016. |
• | Initiated BP-008, a Phase 1 study of BPX-501 to treat post-transplant relapse in adults and children with blood cancers. The safety study, which includes matched as well as haploidentical transplant recipients, will also evaluate the potential for a titrated dose of rimiducid to resolve uncontrolled GvHD while preserving a greater proportion of BPX-501 cells. |
• | Following allowance by the FDA of its Investigational New Drug (IND) application, Bellicum is completing preparations for the start of BP-012, a Phase 1 BPX-601 GoCAR-T™ trial in an initial indication of non-resectable pancreatic cancer. GoCAR-T contains Bellicum’s proprietary iMC activation switch and is designed to treat solid tumors expressing prostate stem cell antigen. The clinical trial (NCT02744287), which is expected to enroll up to 30 patients in a 3+3 dose escalation/de-escalation design, will be conducted at Baylor Sammons Cancer Center in Dallas, Texas. |
• | With its BPX-701 IND allowed by the FDA, the Company is preparing for initiation of BP-011, a Phase 1 clinical trial with its high-affinity T cell receptor (TCR) product candidate. BPX-701 incorporates the CaspaCIDe safety switch and is designed to target malignant cells expressing the preferentially-expressed antigen in melanoma, or PRAME. Initial planned indications include Refractory or Relapsed Acute Myeloid Leukemia and Myelodysplastic Syndromes, with an additional study planned for metastatic uveal melanoma. BP-011 (NCT02743611), which is expected to enroll up to 36 AML/MDS patients in a 3+3 dose escalation/de-escalation design, will be conducted at Oregon Health and Science University and Leiden University Medical Center (LUMC). |
• | In July 2016, the Company decided to support CD19 programs designed to establish clinical proof of concept for CaspaCIDe in the CD19 setting being advanced by two of our academic collaborators, in place of advancing BPX-401. The Company believes that this strategy allows a cost-effective and differentiated approach to the highly competitive landscape of CD19-targeted therapies in development. |
• | Expanded research collaboration with Leiden University Medical Center for discovery of natural high-affinity TCRs for several cancers. Bellicum will provide financial support to LUMC over a three-year term in exchange for the right to exclusively license any high-affinity TCRs discovered under the new agreement. |
• | U.S. patent issued that strengthens the IP around Bellicum’s CaspaCIDe cell therapy safety platform. U.S. patent 9,393,292 was issued to Baylor College of Medicine for a method of cell therapy that enables the selective elimination of administered cells that have been modified to express an inducible caspase-9 protein (iCasp9). Bellicum holds exclusive worldwide rights to the invention. |
BELLICUM PHARMACEUTICALS, INC. | ||||||||||||||||
Unaudited Condensed Balance Sheets | ||||||||||||||||
(in thousands) | ||||||||||||||||
June 30, 2016 | December 31, 2015 | |||||||||||||||
Current Assets: | ||||||||||||||||
Cash and cash equivalents | $ | 49,549 | $ | 70,241 | ||||||||||||
Investment securities, available-for-sale - short-term | 56,025 | 23,820 | ||||||||||||||
Receivables and other current assets | 2,605 | 2,829 | ||||||||||||||
Non-Current Assets: | ||||||||||||||||
Investment securities, available-for-sale, long-term | 30,999 | 56,304 | ||||||||||||||
Property and equipment, net | 10,512 | 6,882 | ||||||||||||||
Other assets, net | 240 | 330 | ||||||||||||||
Total assets | $ | 149,930 | $ | 160,406 | ||||||||||||
Current Liabilities: | ||||||||||||||||
Accounts payable and other accrued liabilities | 6,347 | 7,186 | ||||||||||||||
Other current liabilities | 264 | 259 | ||||||||||||||
Long-Term Liabilities: | ||||||||||||||||
Long-term debt | 14,951 | — | ||||||||||||||
Other liabilities, net of current portion | 881 | 944 | ||||||||||||||
Total Stockholders' Equity | 127,487 | 152,017 | ||||||||||||||
Total liabilities and stockholders' equity | $ | 149,930 | $ | 160,406 | ||||||||||||
BELLICUM PHARMACEUTICALS, INC. | ||||||||||||||||
Unaudited Condensed Statements of Operations | ||||||||||||||||
(in thousands, except share and per share amounts) | ||||||||||||||||
Three Months Ended | Six Months Ended | |||||||||||||||
June 30, | June 30, | |||||||||||||||
2016 | 2015 | 2016 | 2015 | |||||||||||||
Grant Revenues | $ | 101 | $ | 84 | $ | 193 | $ | 191 | ||||||||
Operating Expenses: | ||||||||||||||||
Research and development | 12,181 | 8,012 | 23,169 | 13,730 | ||||||||||||
General and administrative | 4,179 | 2,777 | 8,463 | 4,974 | ||||||||||||
Total operating expenses | 16,360 | 10,789 | 31,632 | 18,704 | ||||||||||||
Operating loss | (16,259 | ) | (10,705 | ) | (31,439 | ) | (18,513 | ) | ||||||||
Interest income (expense), net | (250 | ) | 171 | (145 | ) | 221 | ||||||||||
Net Loss | $ | (16,509 | ) | $ | (10,534 | ) | $ | (31,584 | ) | $ | (18,292 | ) | ||||
Net loss attributable to common shareholders | $ | (16,509 | ) | $ | (10,534 | ) | $ | (31,584 | ) | $ | (18,292 | ) | ||||
Net loss per share attributable to common shareholders, basic and diluted | $ | (0.61 | ) | $ | (0.40 | ) | $ | (1.17 | ) | $ | (0.70 | ) | ||||
Weighted-average common shares outstanding, basic and diluted | 26,910,284 | 26,268,610 | 26,896,405 | 26,264,025 | ||||||||||||
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