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)) |
Title of each class | Trading Symbol(s) | Name of each exchange on which registered |
Common Stock, par value $0.01 per share | BLCM | The Nasdaq Global Market |
Exhibit No. | Description | |
99.1 |
Bellicum Pharmaceuticals, Inc. | ||||||
Dated: March 12, 2020 | By: | /s/ Richard A. Fair | ||||
Richard A. Fair | ||||||
President and Chief Executive Officer | ||||||
• | Bellicum presented new Phase 1 translational data for BPX-601 at the American Society of Clinical Oncology Gastrointestinal Cancers Symposium (ASCO GI) in San Francisco in 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. |
• | 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. |
• | 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 2019 that 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. |
• | In January 2020, Bellicum entered into an asset purchase agreement under which The University of Texas MD Anderson Cancer Center will acquire Bellicum’s approximately 60,000-square-foot Houston facility, 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 Anderson will operate the Houston facility 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. |
• | In December 2019, Bellicum licensed its CaspaCIDe® safety switch to MD Anderson for use in its CD19 CAR-NK program. Under terms of the original license agreement, MD Anderson exercised 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 million and undisclosed future milestone payments and royalties on sales. |
BELLICUM PHARMACEUTICALS, INC. | ||||||||||||||||
Consolidated Balance Sheets | ||||||||||||||||
(unaudited; in thousands) | ||||||||||||||||
December 31, | December 31, | |||||||||||||||
2019 | 2018 | |||||||||||||||
Current Assets: | ||||||||||||||||
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 | — | ||||||||||||||
Non-Current Assets: | ||||||||||||||||
Operating lease right-of-use assets | 1,042 | — | ||||||||||||||
Property and equipment, net | 2,529 | 20,878 | ||||||||||||||
Restricted cash, noncurrent | — | 4,973 | ||||||||||||||
Other assets | 825 | 355 | ||||||||||||||
Total assets | $ | 116,250 | $ | 121,501 | ||||||||||||
Current Liabilities: | ||||||||||||||||
Accounts payable | $ | 2,643 | $ | 3,774 | ||||||||||||
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 Liabilities: | ||||||||||||||||
Long-term debt, net of deferred issuance costs | 25,717 | 35,832 | ||||||||||||||
Long-term lease liabilities | 864 | 91 | ||||||||||||||
Deferred rent | — | 1,296 | ||||||||||||||
Preferred stock | 21,468 | — | ||||||||||||||
Total stockholders' (deficit) equity | (26,217 | ) | 68,478 | |||||||||||||
Total liabilities, preferred stock and stockholders' (deficit) equity | $ | 116,250 | $ | 121,501 | ||||||||||||
BELLICUM PHARMACEUTICALS, INC. | ||||||||||||||||
Consolidated Statements of Operations | ||||||||||||||||
(unaudited; in thousands, except share and per share amounts) | ||||||||||||||||
Three Months Ended | Year Ended | |||||||||||||||
December 31, | December 31, | |||||||||||||||
2019 | 2018 | 2019 | 2018 | |||||||||||||
Revenues | ||||||||||||||||
Grants | $ | 133 | $ | 312 | $ | 2,143 | $ | 1,120 | ||||||||
License fee revenue | 5,000 | — | 5,000 | — | ||||||||||||
Total revenues | 5,133 | 312 | 7,143 | 1,120 | ||||||||||||
Operating Expenses: | ||||||||||||||||
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 | ||||||||||||
Operating loss | (13,900 | ) | (26,567 | ) | (87,364 | ) | (95,466 | ) | ||||||||
Interest expense, net of interest income | (736 | ) | (643 | ) | (2,929 | ) | (2,560 | ) | ||||||||
Change in fair value of warrant liability | (14,342 | ) | — | (19,192 | ) | — | ||||||||||
Other expense | (3 | ) | (10 | ) | (2,992 | ) | (10 | ) | ||||||||
Net loss | $ | (28,981 | ) | $ | (27,220 | ) | $ | (112,477 | ) | $ | (98,036 | ) | ||||
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 | ||||||||||||
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