On May 12, 2016 Adaptimmune Therapeutics plc (Nasdaq:ADAP) ("Adaptimmune" or the "Company"), a leader in T-cell therapy to treat cancer, reported financial results for the first quarter ended March 31, 2016 (Press release, Adaptimmune, MAY 12, 2016, View Source;p=RssLanding&cat=news&id=2167834 [SID:1234512303]).
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As of March 31, 2016, Adaptimmune had a total liquidity position1 of $226.1 million. The Company is reiterating its cash burn guidance and expects its total liquidity position at December 31, 2016, including cash, cash equivalents and short term deposits, to be at least $150 million.
"As we described at our Investor and Analyst meeting in April, we have made substantial progress toward our goal of delivering the first affinity optimized T-cell therapy to market," commented James Noble, Adaptimmune’s Chief Executive Officer. "The first quarter of 2016 was marked by strong momentum as we continued development of our comprehensive pipeline of SPEAR T-cell therapies covering solid and hematologic cancers. In addition to our ongoing clinical activities, we received orphan drug designation and breakthrough therapy designation for our NY-ESO SPEAR T-cell therapy. We also opened our IND for our therapeutic candidate targeting AFP in liver cancer and announced MAGE-A4 as our next target with the goal of achieving IND acceptance in 2017."
Recent Corporate and Clinical Highlights:
Hosted inaugural Investor and Analyst Day on April 22, 2016;
Received orphan drug designation from U.S. Food and Drug Administration ("FDA") for NY-ESO SPEAR T-cell therapy in soft tissue sarcoma;
Received breakthrough therapy designation from FDA for NY-ESO SPEAR T-cell therapy in synovial sarcoma;
Received FDA acceptance of investigational new drug ("IND") application for AFP SPEAR T-cell therapy in liver cancer;
Announced that the Company’s next IND would be for its MAGE-A4 SPEAR T-cell therapy, with the goal of achieving IND acceptance in 2017;
Announced update on NY-ESO SPEAR T-cell data in patients with multiple myeloma, including a 90 percent response rate in conjunction with autologous stem cell transplant and median overall survival of approximately three years (as of January 2016);
Filed patents on over 60 targets expressed on multiple cancers;
Presented overview of commercial-ready manufacturing process, including progress toward opening of manufacturing facility in 2017;
Expanded terms of strategic collaboration agreement with GSK in February 2016 to accelerate Adaptimmune’s lead clinical cancer program, a SPEAR T-cell therapy targeting NY-ESO, with goal of initiating pivotal trials in 4Q16/1Q17;
Established Scientific Advisory Board of leading immunotherapy experts; and
Adopted brand of SPEAR (Specific Peptide Enhanced Affinity Receptor) T-cells to describe proprietary technology that uniquely delivers correctly identified targets and enhanced affinity T-cell receptors with potency to attack tumors, but optimum specificity to minimize risks of cross-reactivity.
Financial Results for the three-month period ended March 31, 2016
Cash / liquidity position: As of March 31, 2016, Adaptimmune had a total liquidity position of $226.1 million, consisting of $163.8 million of cash and cash equivalents and $62.3 million of short-term deposits. As of December 31, 2015, Adaptimmune had a total liquidity position of $248.9 million, consisting of $194.3 million of cash and cash equivalents and $54.6 million of short-term deposits.
Cash burn: The net decrease in the total liquidity position was $22.8 million for the three months ended March 31, 2016, consisting of a $30.5 million decrease in cash and cash equivalents and a $7.7 million increase in short-term deposits.
Revenue: For the three months ended March 31, 2016, revenue was $2.9 million compared to $2.7 million for the three months ended March 31, 2015. This increase was primarily due to revenue relating to development milestones related to the GSK Collaboration and License Agreement achieved in August and December 2015, which is being recognized over the period in which we are delivering services.
Research and development ("R&D") expenses: R&D expenses increased to $13.9 million for the three months ended March 31, 2016 from $6.0 million for the three months ended March 31, 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 personnel expenses for an increased number of employees engaged in R&D.
General and administrative ("G&A") expenses: G&A expenses were $5.9 million for the three months ended March 31, 2016 compared to $2.4 million for the three months ended March 31, 2015. The increase was primarily due to increased personnel costs, increased share-based payment expenses, increased property costs and other costs associated with being a public company.
Net loss: Net loss attributable to holders of the Company’s ordinary shares was $15.6 million for the three months ended March 31, 2016. This equates to $(0.04) per ordinary share or $(0.22) per American Depositary Share.
The Company will not hold a conference call to discuss these results having provided a full update during its 2016 Investor and Analyst Day held on April 22, 2016. A replay of the webcast from the event will be available on the Company’s website for 30 days following the event at ir.adaptimmune.com
Financial Guidance
Adaptimmune is reiterating its cash burn guidance. For the full year 2016, the Company expects its cash burn 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 any cash burn associated with potential new business development activities.
As previously announced, in order to align more closely with many of its peer group of biotechnology companies, the Company has changed its fiscal year to a calendar year and is reporting its financial results in U.S. dollars under U.S. GAAP, effective from January 2016. Further information on these changes is set forth below under ‘Initial Adoption of U.S. GAAP’. The Company’s next fiscal year end will be December 31, 2016.