- Dosing patients in MAGE-A10 lung cancer study at one billion target cell dose -
- Updated MRCLS response data will be presented in an oral presentation at ASCO -
- Guidance confirmed, funded through to early 2020 -
- Conference call to be held today at 8:00 a.m. EDT (1:00 p.m. BST) -
PHILADELPHIA and OXFORD, United Kingdom, May 09, 2018 (GLOBE NEWSWIRE) -- Adaptimmune Therapeutics plc (Nasdaq:ADAP), a leader in T-cell therapy to treat cancer, today reported financial results for the first quarter ended March 31, 2018, as well as provided a business update.
“2018 is off to an outstanding start, and the remainder of the year promises to be even more exciting for Adaptimmune as we look forward to response data from our wholly owned assets in a variety of solid tumors,” commented James Noble, Adaptimmune’s Chief Executive Officer. “The transition of the NY-ESO program to GSK is progressing, our manufacturing capabilities are strengthening, and we have a robust pipeline delivering novel therapeutic approaches to cancer patients. We look forward to presenting further progress in the coming months as we move towards our ambition to be the first to market with an approved TCR T-cell therapy.”
Clinical momentum
Adaptimmune continues to make good progress across all trial cohorts. Clinical data highlights include:
Initial safety data from the MAGE-A4 “basket study” (required to support dose escalation to one billion cells) is on track for the second quarter of 2018. MAGE-A4 response data and initial AFP safety data are anticipated throughout the second half of this year.
Manufacturing progress
In another important step towards its ambition to become a fully integrated cell therapy company, Adaptimmune has now received regulatory approval to produce SPEAR T-cells for all of its wholly owned programs (MAGE‑A10, MAGE-A4, and AFP) at its Philadelphia Navy Yard facility. The Company is routinely manufacturing SPEAR T-cells at the Navy Yard, and achieving cell volumes in the range of the therapeutic doses seen with NY‑ESO in synovial sarcoma.
In addition, Adaptimmune announced in January 2018 (https://bit.ly/2D8A52t ) that it had executed an agreement with Cell and Gene Therapy (CGT) Catapult for its own dedicated manufacturing space to secure vector supply for the medium term for ongoing studies with all three wholly owned SPEAR T-cell therapies. The Catapult space is now officially open.
Highlights
Wholly owned programs
Continued momentum towards safety and response readouts from SPEAR T-cells targeting MAGE-A10 and MAGE-A4 in multiple solid tumors throughout the second half of 2018, and initial safety data from AFP in hepatocellular carcinoma anticipated in late 2018
NY-ESO program (partnered with GSK)
Compelling clinical data supports the potential of Adaptimmune’s TCR T-cell therapies to treat solid tumors
Manufacturing
Adaptimmune is building a fully integrated cell therapy company
Other corporate news
Adaptimmune is in a strong financial position to deliver success with SPEAR T-cell therapies
Financial Results for the three-month period ended March 31, 2018
Financial guidance
The Company believes that its existing cash, cash equivalents, marketable securities and income from GSK upon transition of the NY-ESO program will fund the Company’s current operating plan through to early 2020.
_________________________________________
1 Total liquidity is a non-GAAP financial measure, which is explained and reconciled to the most directly comparable financial measures prepared in accordance with GAAP below.
2 ASC 606, Revenue from Contracts with Customers.
Conference call information
The Company will host a live teleconference and webcast to provide additional details at 8:00 a.m. EDT (1:00 p.m. BST) today, May 9, 2018. The live webcast of the conference call will be available via the events page of Adaptimmune’s corporate website at www.adaptimmune.com. An archive will be available after the call at the same address. To participate in the live conference call, if preferred, please dial 1-833-652-5917 (U.S.) or 1-430-775-1624 (International). After placing the call, please ask to be joined into the Adaptimmune conference call and provide the confirmation code (2967789).
About Adaptimmune
Adaptimmune is a clinical-stage biopharmaceutical company focused on the development of novel cancer immunotherapy products. The Company’s unique SPEAR (Specific Peptide Enhanced Affinity Receptor) T‑cell platform enables the engineering of T-cells to target and destroy cancer, including solid tumors. Adaptimmune is currently conducting clinical trials with SPEAR T-cells targeting MAGE-A4, -A10, and AFP across several solid tumor indications. GlaxoSmithKline plc (LSE:GSK) (NYSE:GSK) exercised its option to exclusively license the right to research, develop, and commercialize Adaptimmune’s NY-ESO SPEAR T-cell therapy program in September 2017. Transition of this program to GSK is ongoing. The Company is located in Philadelphia, USA and Oxfordshire, U.K. For more information, please visit http://www.adaptimmune.com
Forward-looking statements
This release contains “forward-looking statements” within the meaning of the Private Securities Litigation Reform Act of 1995 (PSLRA). These forward-looking statements involve certain risks and uncertainties. Such risks and uncertainties could cause our actual results to differ materially from those indicated by such forward-looking statements, and include, without limitation: the success, cost and timing of our product development activities and clinical trials and our ability to successfully advance our TCR therapeutic candidates through the regulatory and commercialization processes. For a further description of the risks and uncertainties that could cause our actual results to differ materially from those expressed in these forward-looking statements, as well as risks relating to our business in general, we refer you to our Annual Report on Form 10-K filed with the Securities and Exchange Commission (SEC) on March 15, 2018, and our other SEC filings. The forward-looking statements contained in this press release speak only as of the date the statements were made and we do not undertake any obligation to update such forward‑looking statements to reflect subsequent events or circumstances.
Total liquidity (a non-GAAP financial measure)
Total Liquidity is the total of cash and cash equivalents, and marketable securities. Each of these components appears in the Consolidated Balance Sheet. The U.S. GAAP financial measure most directly comparable to Total Liquidity is cash and cash equivalents as reported in the Consolidated Financial Statements, which reconciles to Total Liquidity as follows:
(in thousands) (unaudited) | March 31, 2018 | December 31, 2017 | ||||
Cash and cash equivalents | $ | 53,375 | $ | 84,043 | ||
Marketable securities | 108,459 | 124,218 | ||||
Total Liquidity | $ | 161,834 | $ | 208,261 | ||
The Company believes that the presentation of Total Liquidity provides useful information to investors because management reviews Total Liquidity as part of its management of overall liquidity, financial flexibility, capital structure and leverage.
Condensed Consolidated Statement of Operations
(unaudited, in thousands, except per share data)
Three months ended March 31, | |||||||||
2018 | 2017 | ||||||||
Revenue | $ | 8,196 | $ | 2,857 | |||||
Operating expenses | |||||||||
Research and development | (25,732 | ) | (18,615 | ) | |||||
General and administrative | (11,204 | ) | (6,463 | ) | |||||
Total operating expenses | (36,936 | ) | (25,078 | ) | |||||
Operating loss | (28,740 | ) | (22,221 | ) | |||||
Interest income | 659 | 240 | |||||||
Other income, net | 7,130 | 430 | |||||||
Loss before income taxes | (20,951 | ) | (21,551 | ) | |||||
Income taxes | (127 | ) | (231 | ) | |||||
Net loss attributable to ordinary shareholders | $ | (21,078 | ) | $ | (21,782 | ) | |||
Net loss per ordinary share - Basic and diluted | $ | (0.04 | ) | $ | (0.05 | ) | |||
Weighted average shares outstanding - Basic and diluted | 562,381,995 | 428,961,818 | |||||||
Condensed Consolidated Balance Sheets
(unaudited, in thousands)
March 31, 2018 | December 31, 2017 | ||||||
Assets | |||||||
Current assets | |||||||
Cash and cash equivalents | $ | 53,375 | $ | 84,043 | |||
Marketable securities - available-for-sale debt securities | 108,459 | 124,218 | |||||
Accounts receivable, net of allowance for doubtful accounts of $- and $- | 5,052 | 206 | |||||
Other current assets and prepaid expenses (including current portion of clinical materials) | 28,777 | 21,716 | |||||
Total current assets | 195,663 | 230,183 | |||||
Restricted cash | 4,360 | 4,253 | |||||
Clinical materials | 4,572 | 4,695 | |||||
Property, plant and equipment, net | 41,235 | 40,679 | |||||
Intangibles, net | 1,238 | 1,337 | |||||
Total assets | 247,068 | 281,147 | |||||
Liabilities and stockholders’ equity | |||||||
Current liabilities | |||||||
Accounts payable | 5,051 | 8,378 | |||||
Accrued expenses and other accrued liabilities | 19,650 | 27,201 | |||||
Deferred revenue | 27,221 | 38,735 | |||||
Total current liabilities | 51,922 | 74,314 | |||||
Other liabilities, non-current | 3,884 | 3,849 | |||||
Total liabilities | 55,806 | 78,163 | |||||
Stockholders’ equity | |||||||
Common stock - Ordinary shares par value £0.001, 701,103,126 authorized and 564,859,960 issued and outstanding (2017: 701,103,126 authorized and 562,119,334 issued and outstanding) | 858 | 854 | |||||
Additional paid in capital | 461,603 | 455,401 | |||||
Accumulated other comprehensive loss | (27,136 | ) | (21,641 | ) | |||
Accumulated deficit | (244,063 | ) | (231,630 | ) | |||
Total stockholders’ equity | 191,262 | 202,984 | |||||
Total liabilities and stockholders’ equity | $ | 247,068 | $ | 281,147 | |||
Condensed Consolidated Cash Flow Statement
(unaudited, in thousands)
Three months ended March 31, | |||||||
2018 | 2017 | ||||||
Cash flows from operating activities | |||||||
Net loss | $ | (21,078 | ) | $ | (21,782 | ) | |
Adjustments to reconcile net loss to net cash used in operating activities: | |||||||
Depreciation | 1,740 | 986 | |||||
Amortization | 143 | 60 | |||||
Share-based compensation expense | 4,672 | 2,686 | |||||
Realized loss on available-for-sale debt securities | 1,163 | - | |||||
Unrealized foreign exchange gains | (7,862 | ) | (52 | ) | |||
Other | 124 | - | |||||
Changes in operating assets and liabilities: | |||||||
Increase in receivables and other operating assets | (10,179 | ) | (1,813 | ) | |||
Increase in non-current operating assets | (123 | ) | (17 | ) | |||
Decrease in payables and deferred revenue | (15,879 | ) | (8,507 | ) | |||
Net cash used in operating activities | (47,279 | ) | (28,439 | ) | |||
Cash flows from investing activities | |||||||
Acquisition of property, plant and equipment | (1,904 | ) | (12,249 | ) | |||
Acquisition of intangibles | (10 | ) | (242 | ) | |||
Maturity of short-term deposits | - | 7,854 | |||||
Investment in short-term deposits | - | (18,000 | ) | ||||
Maturity or redemption of marketable securities | 28,043 | - | |||||
Investment in marketable securities | (12,490 | ) | - | ||||
Net cash provided by (used in) investing activities | 13,639 | (22,637 | ) | ||||
Cash flows from financing activities | |||||||
Proceeds from issuance of common stock, net of issuance costs $4,774 | - | 61,397 | |||||
Proceeds from exercise of stock options | 1,534 | - | |||||
Net cash provided by financing activities | 1,534 | 61,397 | |||||
Effect of currency exchange rate changes on cash, cash equivalents and restricted cash | 1,545 | 1,491 | |||||
Net (decrease) increase in cash, cash equivalents and restricted cash | (30,561 | ) | 11,812 | ||||
Cash, cash equivalents and restricted cash at start of period | 88,296 | 162,796 | |||||
Cash, cash equivalents and restricted cash at end of period | $ | 57,735 | $ | 174,608 | |||
Adaptimmune Contacts:
Media Relations:
Sébastien Desprez – VP, Communications and Investor Relations
T: +44 1235 430 583
M: +44 7718 453 176
[email protected]
Investor Relations:
Juli P. Miller, Ph.D. – Director, Investor Relations
T: +1 215 825 9310
M: +1 215 460 8920
[email protected]
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