– U.S. Food and Drug Administration (FDA) lifted partial clinical hold of myxoid/round cell liposarcoma (MRCLS) study of NY-ESO SPEAR™ T-cell therapy; initiation of screening expected in 4Q 2016 –
– Initiated first site for triple tumor study with wholly-owned MAGE-A10 SPEAR T-cells –
– Initiated new patient cohort in synovial sarcoma NY-ESO program –
– Started recruitment of additional patients under amended protocol in ovarian NY-ESO program –
– Executed key agreements with Merck, PCT, and The MD Anderson Cancer Center –
– Adaptimmune reaffirms financial guidance –
– Conference call to be held today at 8:00 a.m. EST (1:00 p.m. GMT) –
PHILADELPHIA and OXFORD, United Kingdom, Nov. 10, 2016 (GLOBE NEWSWIRE) -- Adaptimmune Therapeutics plc (Nasdaq:ADAP), a leader in T-cell therapy to treat cancer, today reported financial results for the third quarter ended September 30, 2016.
“Adaptimmune has delivered strong momentum since our last update,” said James Noble, Adaptimmune’s Chief Executive Officer. “We have initiated the first site for a triple tumor study with our wholly-owned MAGE-A10 SPEAR T-cells under our new partnership with MD Anderson, and initiated Cohort 4 in our NY-ESO synovial sarcoma study, as well as commenced recruitment of new patients in our NY-ESO ovarian cancer study under an amended protocol. In addition, we have executed a number of strategic agreements to accelerate our ability to develop, evaluate, and manufacture our affinity enhanced T-cell therapies for patients suffering from a wide array of solid tumor cancers. We are well placed for continued execution and to generate data from studies in multiple cancers with our SPEAR T-cell therapies in 2017.”
Mr. Noble continued, “As we recently announced, the FDA has lifted the partial clinical hold on the planned NY-ESO MRCLS study, and we expect to start screening patients shortly. Our goal remains to be the first company to file for approval with a TCR therapy.”
Recent Corporate and R&D Highlights:
- Partial clinical hold lifted by FDA of NY-ESO SPEAR T-cell therapy study in MRCLS;
- Initiation of screening in up to 15 MRCLS patients expected in 4Q 2016 with results from this revised study informing a potential future registration trial;
- Established collaboration and supply agreement for combination study of Merck’s PD-1 inhibitor and the Company’s NY-ESO SPEAR T-cell therapy in multiple myeloma; initiation expected in 1H 2017;
- Secured strategic agreement with PCT for dedicated manufacturing capacity;
- Entered strategic alliance with MD Anderson to expedite T-cell therapy development;
- Initiated MD Anderson as the first site for MAGE-A10 SPEAR T-cell therapy triple tumor study in urothelial cancer, melanoma, or squamous cell carcinoma of the head and neck;
- Presented data demonstrating response to NY-ESO SPEAR T-cell therapy in synovial sarcoma patients with low NY-ESO expression (Cohort 2) (ESMO 2016);
- Presented data indicating that fludarabine is required in preconditioning (Cohort 3) (ESMO 2016);
- Commenced enrollment in NY-ESO synovial sarcoma Cohort 4 with a modified preconditioning regimen including fludarabine;
- Started recruitment of additional ovarian cancer patients under an amended protocol using NY-ESO SPEAR T-cell therapy with a modified preconditioning regimen including fludarabine;
- Completed preclinical evaluation of MAGE-A4 SPEAR T-cells, with data demonstrating that MAGE-A4 is an attractive target with widespread expression in multiple tumor types; IND planned to be filed in 2017 (data to be presented at SITC 2016); and
- Completed initial evaluation of a second generation NY-ESO SPEAR-T cell expressing a dominant negative TGF-Beta receptor, with data indicating that these SPEAR T-cells may overcome TGF-Beta tumor-mediated immunosuppression (to be presented at SITC 2016).
Financial Results for the Three-Month Period ended September 30, 2016
- Cash / liquidity position: As of September 30, 2016, Adaptimmune had $140.4 million of cash and cash equivalents and $47.1 million of short-term deposits representing a total liquidity position1 of $187.5 million. For the three months ended September 30, 2016, the decrease in cash and cash equivalents was $10.5 million and the decrease in short-term deposits was $7.9 million, representing a decrease in total liquidity position of $18.4 million.
- Revenue: For the three months ended September 30, 2016, revenue was $2.4 million compared to $4.9 million for the three months ended September 30, 2015. This decrease was primarily due to the impact of development milestones achieved in the three months ended in September 30, 2015 under the GSK Collaboration and License Agreement.
- Research and development (“R&D”) expenses: R&D expenses increased to $15.6 million for the three months ended September 30, 2016 from $8.9 million for the three months ended September 30, 2015, primarily due to increased period-over-period costs associated with ongoing clinical trials of the Company’s NY-ESO and MAGE-A10 SPEAR T-cell therapies; preparation for a study with the Company’s SPEAR T-cell therapy targeting AFP; and increased personnel expenses.
- General and administrative (“G&A”) expenses: G&A expenses were $5.4 million for the three months ended September 30, 2016 compared to $4.4 million for the three months ended September 30, 2015. The increase was primarily due to increased personnel costs.
- Net loss: Net loss attributable to holders of the Company’s ordinary shares was $18.5 million for the three months ended September 30, 2016. This equates to $(0.04) per ordinary share or $(0.26) per American Depositary Share.
1 Total liquidity position is a non GAAP financial measure, which is explained and reconciled to the most directly comparable financial measures prepared in accordance with GAAP below.
Adaptimmune is reiterating its guidance. For the full year 2016, the Company expects its decrease in total liquidity position to be between $80 and $100 million and expects its total liquidity position at December 31, 2016, including cash, cash equivalents and short term deposits, to be at least $150 million. This guidance excludes the effect of any potential new business development activities.