UNITED STATES
SECURITIES AND EXCHANGE COMMISSION
Washington, D.C. 20549
FORM 8-K
CURRENT REPORT
Pursuant to Section 13 or 15(d)
of the Securities Exchange Act of 1934
May 27, 2016
Date of Report (Date of earliest event reported)
Bellicum Pharmaceuticals, Inc.
(Exact name of registrant as specified in its charter)
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) | |
Registrant’s telephone number, including area code: (832) 384-1100
Check the appropriate box below if the Form 8-K filing is intended to simultaneously satisfy the filing obligations of the registrant under any of the following provisions:
Check the appropriate box below if the Form 8-K filing is intended to simultaneously satisfy the filing obligations of the registrant under any of the following provisions:
o | Written communications pursuant to Rule 425 under the Securities Act (17 CFR 230.425) |
o | Soliciting material pursuant to Rule 14a-12 under the Exchange Act (17 CFR 240.14a-12) |
o | Pre-commencement communications pursuant to Rule 14d-2(b) under the Exchange Act (17 CFR 240.14d-2(b)) |
o | Pre-commencement communications pursuant to Rule 13e-4(c) under the Exchange Act (17 CFR 240.13e-4(c)) |
Item 1.01 Entry into a Material Definitive Agreement
On May 27, 2016, Bellicum Pharmaceuticals, Inc. (the “Company”) and Academisch Ziekenhuis Leiden, also acting under the name Leiden University Medical Centre (“Leiden”), entered into a research collaboration agreement (the “Agreement”) pursuant to which the Company will provide Leiden with financial support for research to discover and validate high-affinity T cell receptor (“TCR”) product candidates targeting several cancer-associated antigens (the “Research”).
As consideration for Leiden’s performance of the Research, the Company agreed to pay Leiden an aggregate of EUR 2,547,415 in quarterly installments during the three-year term of the Research. With respect to any inventions arising from the Research that are relevant to or useful for any high affinity TCR that is studied in the Research, Leiden granted the Company an exclusive option to obtain an exclusive, worldwide license to practice and exploit such inventions. The parties agreed to negotiate in good faith the commercially reasonable terms of each such license agreement entered into between the parties, based on terms similar to those set forth in the previously executed license agreement between the parties and those specified in the Agreement.
The Research will be conducted during a three year term, after which the Agreement will expire. The Company and Leiden have agreed to negotiate in good faith a potential extension of such term, dependent on Leiden’s progress in the performance of the Research. Either party may terminate the Agreement upon a material breach by the other party that remains uncured following 30 days after the date of written notice of such breach. Leiden may terminate the Agreement in the event of a failure by the Company to pay any amounts due under the Agreement that remains uncured on the date that is 30 days after written notice of such failure.
On June 2, 2016, the Company issued a press release announcing the Agreement. A copy of this press release is attached hereto as Exhibit 99.1.
Item 9.01 Financial Statements and Exhibits.
(d) Exhibits
Exhibit No. | Description | |
99.1 | Press Release dated June 2, 2016. | |
SIGNATURES
Pursuant to the requirements of the Securities Exchange Act of 1934, the Registrant has duly caused this report to be signed on its behalf by the undersigned hereunto duly authorized.
Bellicum Pharmaceuticals, Inc. | ||||||
Dated: June 2, 2016 | By: | /s/ Ken Moseley | ||||
Senior Vice President and General Counsel | ||||||
Item 9.01 Financial Statements and Exhibits.
(d) Exhibits
Exhibit No. | Description | |
99.1 | Press Release dated June 2, 2016. | |
Exhibit 99.1
Bellicum Pharmaceuticals Enters into Research Collaboration with Leiden University Medical Center to Discover Natural High-Affinity TCRs
New collaboration builds on current license and research agreement for TCR candidates, including BPX-701
HOUSTON, TX – June 2, 2016 – Bellicum Pharmaceuticals, Inc. (Nasdaq: BLCM), a clinical stage biopharmaceutical company focused on discovering and developing novel cellular immunotherapies for cancers and orphan inherited blood disorders, today announced it has entered into a research agreement with Leiden University Medical Center (LUMC), Netherlands, to discover and validate natural high-affinity TCR (T cell receptor) product candidates targeting several cancers. The new collaboration builds on an earlier agreement with LUMC that gave Bellicum worldwide rights to TCR product candidates targeting solid tumors that express PRAME (preferentially-expressed antigen in melanoma) and other antigens.
“We are enthusiastic about the potential of TCRs that incorporate our switch technology to produce a targeted, potent and controlled attack on certain cancers,” said Tom Farrell, President and Chief Executive Officer of Bellicum Pharmaceuticals. “Dr. Mirjam Heemskerk and her group from the Department of Hematology of the LUMC, have made significant breakthroughs in the development of natural high-affinity TCRs, and we look forward to their continued discoveries as we prepare to launch clinical studies this year of our first TCR, BPX-701, under our current license from Leiden.”
Under terms of the new collaboration, 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 agreement.
TCRs are engineered T cells that become activated in the presence of cancer cells containing a target antigen. Bellicum’s first TCR product candidate, BPX-701 targeting PRAME, is expected to enter Phase 1/2 clinical trials in mid-2016 to treat refractory acute myeloid leukemia (AML) and myelodysplastic syndromes (MDS). BPX-701 was licensed from Leiden in 2015 and incorporates Bellicum’s proprietary safety mechanism, CaspaCIDe®, for improved control over the cells.
About Bellicum Pharmaceuticals
Bellicum is a clinical stage biopharmaceutical company focused on discovering and developing cellular immunotherapies for cancers and orphan inherited blood disorders. Bellicum is using its proprietary Chemical Induction of Dimerization (CID) technology platform to engineer and control components of the immune system. Bellicum is developing next-generation product
candidates in some of the most important areas of cellular immunotherapy, including hematopoietic stem cell transplantation (HSCT), and CAR T and TCR cell therapies. More information can be found at www.bellicum.com.
About Leiden University Medical Center
As a center of medical innovations, the Leiden University Medical Center (LUMC) strives towards an internationally recognized leading role in the improvement of quality of health care. The core businesses of LUMC are patient care, research, education and training. Research of Dr. Mirjam Heemskerk and her group from the department of Hematology of the LUMC, has led to the discovery of TCRs with high specificity for tumor cells that now can be explored in clinical studies. The research of the Department of Hematology aims to translate basic research achievements into clinical applications in the field of hematopoietic stem cell transplantation and immune therapy of cancer. The establishment of the license agreement has been facilitated by knowledge exchange office Luris, on behalf of LUMC.
Forward-Looking Statement
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 TCRs and to CaspaCIDe; the success of our collaboration with LUMC; the effectiveness of BPX-701, its possible range of application and potential curative effects and safety in the treatment of diseases including as compared to other treatment options and competitive therapies; the timing and success of our clinical trials; the timing of regulatory filings for BPX-701; our research and development activities relating to BPX-701; and the potential applications of our product candidate BPX-701. 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 for the year ended December 31, 2015. 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.
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Investors:
Alan Musso, CFO
Bellicum Pharmaceuticals
832-384-1116
amusso@bellicum.com
amusso@bellicum.com
Media:
Brad Miles
BMC Communications
646-513-3125
bmiles@bmccommunications.com
For contact with the Leiden University Medical Center, contact the press officer at directorate Communication, telephone +31 71 526 8005, e-mail: cummunicatie@lumc.nl.
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