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: November 6, 2019 | By: | /s/ Richard A. Fair | ||||
Richard A. Fair | ||||||
President and Chief Executive Officer | ||||||
• | Bellicum anticipates presenting new translational data from cohort 5B in the BPX-601 Phase 1/2 trial in early 2020. These data are expected to provide additional evidence on the proposed mechanisms of action of iMC activation in BPX-601, including cell expansion and persistence, cytokine production, tumor infiltration, and CAR-T activity in the tumor microenvironment. Bellicum is currently enrolling cohort 5C. Data from this cohort will be used to evaluate the safety of repeat rimiducid dosing to re-activate iMC over time, which is intended to deepen and extend the treatment effect. Patient enrollment has proceeded more slowly than anticipated primarily as the result of the amended protocol limiting enrollment to second line patients. Initial results from Cohort 5C are expected to be presented in the second half of 2020. |
• | In response to Bellicum’s IND application for BPX-603, the FDA has responded with a request for additional preclinical data to better characterize the potential risk of off-tumor / on-target toxicity before IND clearance. Bellicum is engaged in discussions with the FDA to align on a plan to address the request. |
• | An abstract for a preclinical investigation from Bellicum’s natural killer cell GoCAR program has been accepted for poster presentation at the Society for Immunotherapy of Cancer (SITC) Annual Meeting on November 8, 2019. |
• | Bellicum is actively pursuing a strategic partner for rivo-cel to lead future development and commercialization for this product candidate. Bellicum has reduced and expects to continue to reduce its rivo-cel related activities. |
• | In August, Bellicum announced receipt of aggregate gross proceeds of $69.6 million, including gross proceeds of $57.5 million from an underwritten public offering and a $12.1 million private placement option fee related to its private placement of up to $70 million in additional potential gross proceeds. |
• | Bellicum is actively pursuing a partner to purchase its manufacturing facility and establish a preferred supply agreement with the goal of reducing operating costs while maintaining viral vector and cell therapy development capabilities and dedicated manufacturing capacity for its programs. |
BELLICUM PHARMACEUTICALS, INC. | ||||||||||||||||
Unaudited Condensed Consolidated Balance Sheets | ||||||||||||||||
(in thousands) | ||||||||||||||||
September 30, | December 31, | |||||||||||||||
2019 | 2018 | |||||||||||||||
Current Assets: | ||||||||||||||||
Cash and cash equivalents | $ | 99,151 | $ | 43,695 | ||||||||||||
Investment securities, available-for-sale, short-term | 4,152 | 49,304 | ||||||||||||||
Receivables and other current assets | 1,562 | 2,296 | ||||||||||||||
Non-Current Assets: | ||||||||||||||||
Property and equipment, net | 16,204 | 20,878 | ||||||||||||||
Right-of-use assets | 6,234 | — | ||||||||||||||
Restricted cash | 3,603 | 4,973 | ||||||||||||||
Other assets, net | 3,026 | 355 | ||||||||||||||
Total assets | $ | 133,932 | $ | 121,501 | ||||||||||||
Current Liabilities: | ||||||||||||||||
Accounts payable and other accrued liabilities | 15,663 | 12,363 | ||||||||||||||
Warrant Liability | 37,842 | — | ||||||||||||||
Private Placement option liability | 12,094 | — | ||||||||||||||
Current maturities of long-term debt | 8,000 | — | ||||||||||||||
Other current liabilities | 2,839 | 3,441 | ||||||||||||||
Long-Term Liabilities: | ||||||||||||||||
Long-term debt | 28,494 | 35,832 | ||||||||||||||
Other liabilities, net of current portion | 6,163 | 1,387 | ||||||||||||||
Preferred Stock | 21,608 | — | ||||||||||||||
Total Stockholders' Equity | 1,229 | 68,478 | ||||||||||||||
Total liabilities and stockholders' equity | $ | 133,932 | $ | 121,501 | ||||||||||||
BELLICUM PHARMACEUTICALS, INC. | ||||||||||||||||
Unaudited Condensed Consolidated Statements of Operations | ||||||||||||||||
(in thousands, except share and per share amounts) | ||||||||||||||||
Three Months Ended | Nine Months Ended | |||||||||||||||
September 30, | September 30, | |||||||||||||||
2019 | 2018 | 2019 | 2018 | |||||||||||||
Grant Revenues | $ | 103 | $ | 292 | $ | 2,010 | $ | 808 | ||||||||
Operating Expenses: | ||||||||||||||||
Research and development | 14,331 | 16,413 | 51,008 | 51,361 | ||||||||||||
License fees | — | 139 | 203 | 319 | ||||||||||||
General and administrative | 9,209 | 6,968 | 24,263 | 18,027 | ||||||||||||
Total operating expenses | 23,540 | 23,520 | 75,474 | 69,707 | ||||||||||||
Operating loss | (23,437 | ) | (23,228 | ) | (73,464 | ) | (68,899 | ) | ||||||||
Change in fair value of warrant liability | (4,850 | ) | — | (4,850 | ) | — | ||||||||||
Interest expense, net of interest income | (756 | ) | (573 | ) | (2,193 | ) | (1,917 | ) | ||||||||
Other expense | $ | (2,989 | ) | — | (2,989 | ) | — | |||||||||
Net loss attributable to common shareholders | $ | (32,032 | ) | (23,801 | ) | (83,496 | ) | (70,816 | ) | |||||||
Net loss per share attributable to common shareholders, basic and diluted | $ | (0.68 | ) | $ | (0.55 | ) | $ | (1.82 | ) | $ | (1.81 | ) | ||||
Weighted-average common shares outstanding, basic and diluted | 47,208,958 | 43,334,727 | 45,845,928 | 39,168,559 |
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