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 May 9, 2016. |
Bellicum Pharmaceuticals, Inc. | ||||||
Dated: May 9, 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 May 9, 2016. |
• | Reported new interim data from BP-004 trial, showing disease-free outcomes in pediatric patients, including those with blood cancers who had undergone T-depleted, haploidentical hematopoietic stem cell transplantation (HSCT) followed by BPX-501 donor T-cell replacement. At the 42nd Annual Meeting of the European Society for Blood and Marrow Transplantation (EBMT), preliminary outcomes of 17 pediatric leukemia patients were reviewed in an oral presentation, showing that BPX-501 cells expand in vivo and persist over time, contributing to adaptive immunity. Additionally, the relapse rate compared favorably with that of historical controls, with 16 of 17 patients in the trial showing disease-free outcomes. The median follow-up period for these patients was approximately seven months. Initial outcomes for nonmalignant patients at the same site were also reviewed, which showed that all 24 children treated remain disease-free (median follow-up period of approximately seven months), consistent with earlier results presented at the 57th Annual Meeting of the American Society of Hematology (ASH) in |
• | Received orphan drug designation from FDA for the combination of BPX-501 genetically modified T cells and activator agent rimiducid as “replacement T-cell therapy for the treatment of immunodeficiency and Graft versus Host Disease after allogeneic hematopoietic stem cell transplant.” |
• | Preparing to meet with the European Medicines Agency and U.S. FDA, with the goal of defining the path to regulatory filing and approval. |
BELLICUM PHARMACEUTICALS, INC. | ||||||||
Condensed Balance Sheets | ||||||||
(in thousands) | ||||||||
March 31, 2016 | December 31, 2015 | |||||||
Current Assets: | ||||||||
Cash and cash equivalents | $ | 61,790 | $ | 70,241 | ||||
Investment securities, available-for-sale - short-term | 46,482 | 23,820 | ||||||
Receivables and other current assets | 2,629 | 2,829 | ||||||
Non-Current Assets: | ||||||||
Investment securities, available-for-sale, long-term | 43,536 | 56,304 | ||||||
Property and equipment, net | 8,731 | 6,882 | ||||||
Other assets, net | 346 | 330 | ||||||
Total assets | $ | 163,514 | $ | 160,406 | ||||
Current Liabilities: | ||||||||
Accounts payable and other accrued liabilities | 7,143 | 7,186 | ||||||
Other current liabilities | 261 | 259 | ||||||
Long-Term Liabilities: | ||||||||
Long-term debt | 14,829 | — | ||||||
Other liabilities, net of current portion | 915 | 944 | ||||||
Total Stockholders' Equity | 140,366 | 152,017 | ||||||
Total liabilities and stockholders' equity | $ | 163,514 | $ | 160,406 | ||||
BELLICUM PHARMACEUTICALS, INC. | ||||||||
Condensed Statements of Operations | ||||||||
(in thousands, except share and per share amounts) | ||||||||
Three Months Ended | ||||||||
March 31, | ||||||||
2016 | 2015 | |||||||
Grant Revenues | $ | 92 | $ | 107 | ||||
Operating Expenses: | ||||||||
Research and development | 10,988 | 5,718 | ||||||
General and administrative | 4,284 | 2,197 | ||||||
Total operating expenses | 15,272 | 7,915 | ||||||
Operating loss | (15,180 | ) | (7,808 | ) | ||||
Interest income, net | 105 | 50 | ||||||
NET LOSS | $ | (15,075 | ) | $ | (7,758 | ) | ||
Net loss attributable to common shareholders | $ | (15,075 | ) | $ | (7,758 | ) | ||
Net loss per share attributable to common shareholders, basic and diluted | $ | (0.56 | ) | $ | (0.30 | ) | ||
Weighted-average common shares outstanding, basic and diluted | 26,882,526 | 26,259,392 | ||||||
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