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Globe Newswire 6-Nov-2018 7:30 AM
Progressed to expansion phase for MAGE-A10 triple tumor and MAGE-A4 basket studies after favorable safety review of Cohort 3 data with target doses of 5 billion cells
Continued dosing in Cohort 1 of AFP study, with anticipated dose escalation to Cohort 2 early 2019
~$26 million upon completion of transition of NY-ESO SPEAR T-cell program IND to GSK
Closed registered direct offering with net proceeds of ~$100 million; guidance updated,
funded to late 2020
Conference call to be held today at 8:00 a.m. EST (1:00 p.m. GMT)
PHILADELPHIA and OXFORD, United Kingdom, Nov. 06, 2018 (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, 2018, and provided a business update.
"We have now completed the three dose escalation cohorts of the studies with MAGE-A4 and MAGE-A10, our leading wholly owned programs. The Safety Review Committee has agreed that the higher pre-conditioning regimen and cell doses are tolerable and there were no dose limiting toxicities. These studies will now move into the expansion phase, which allows us to treat patients with up to ten billion cells, without a pre-determined stagger across a broad range of tumor types. We have also continued dosing patients in the AFP study with 100 million cells and anticipate escalating to Cohort 2 in early 2019. We expect to report our next clinical data by no later than our first quarter financial results in May 2019," said James Noble, Chief Executive Officer.
Clinical momentum in wholly owned programs
Ongoing MAGE-A10 and MAGE-A4 studies
ESMO data
Data from ongoing AFP study
NY-ESO data updates to be presented at SITC
Manufacturing
Adaptimmune on its way to becoming a fully integrated cell therapy company
Other corporate news
Adaptimmune is focused on its next stage of development and in a strong position to deliver success with SPEAR T-cell therapies
Financial Results for the three and nine month period ended September 30, 2018
______________________________________
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.
Financial guidance
The Company believes that its existing cash, cash equivalents and marketable securities will fund the Company's current operations through to late 2020.
Conference call information
The Company will host a live teleconference and webcast at 8:00 a.m. EST (1:00 p.m. GMT) today. 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, please dial (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 (2458438).
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. 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 Quarterly Report on Form 10-Q filed with the Securities and Exchange Commission (SEC) on August 2, 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) |
September, 2018 |
December 31, 2017 |
|||
Cash and cash equivalents | $ | 153,081 | $ | 84,043 | |
Marketable securities | 84,652 | 124,218 | |||
Total Liquidity | $ | 237,733 | $ | 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 September 30, |
Nine months ended September 30, |
||||||||||||||
2018 | 2017 | 2018 | 2017 | ||||||||||||
Revenue | $ | 40,792 | $ | 27,185 | 58,026 | 33,563 | |||||||||
Operating expenses | |||||||||||||||
Research and development | (23,484 | ) | (24,034 | ) | (75,500 | ) | (62,240 | ) | |||||||
General and administrative | (10,290 | ) | (8,111 | ) | (32,785 | ) | (22,284 | ) | |||||||
Total operating expenses | (33,774 | ) | (32,145 | ) | (108,285 | ) | (84,524 | ) | |||||||
Operating income (loss) | 7,018 | (4,960 | ) | (50,259 | ) | (50,961 | ) | ||||||||
Interest income | 606 | 705 | 1,805 | 1,465 | |||||||||||
Other (expense) income, net | (2,249 | ) | 3,602 | (10,525 | ) | 7,242 | |||||||||
Income (loss) before income taxes | 5,375 | (653 | ) | (58,979 | ) | (42,254 | ) | ||||||||
Income taxes | (133 | ) | (225 | ) | (362 | ) | (621 | ) | |||||||
Net income (loss) attributable to ordinary shareholders | $ | 5,242 | $ | (878 | ) | $ | (59,341 | ) | $ | (42,875 | ) | ||||
Net income (loss) per ordinary share | |||||||||||||||
Basic | $ | 0.01 | $ | - | $ | (0.10 | ) | $ | (0.08 | ) | |||||
Diluted | 0.01 | - | (0.10 | ) | (0.08 | ) | |||||||||
Weighted average shares outstanding: | |||||||||||||||
Basic | 582,004,954 | 561,239,864 | 573,796,275 | 516,352,141 | |||||||||||
Diluted | 621,764,201 | 561,239,864 | 573,796,275 | 516,352,141 | |||||||||||
Condensed Consolidated Balance Sheets
(unaudited, in thousands)
September 30, 2018 |
December 31, 2017 |
||||||
Assets | |||||||
Current assets | |||||||
Cash and cash equivalents | $ | 153,081 | $ | 84,043 | |||
Marketable securities - available-for-sale debt securities | 84,652 | 124,218 | |||||
Accounts receivable, net of allowance for doubtful accounts of $- and $- | 2,031 | 206 | |||||
Other current assets and prepaid expenses (including current portion of clinical materials) | 21,841 | 21,716 | |||||
Total current assets | 261,605 | 230,183 | |||||
Restricted cash | 4,163 | 4,253 | |||||
Clinical materials | 4,205 | 4,695 | |||||
Property, plant and equipment, net | 38,137 | 40,679 | |||||
Intangibles, net | 1,515 | 1,337 | |||||
Total assets | 309,625 | 281,147 | |||||
Liabilities and stockholders' equity | |||||||
Current liabilities | |||||||
Accounts payable | 3,907 | 8,378 | |||||
Accrued expenses and other accrued liabilities | 24,314 | 27,201 | |||||
Deferred revenue | 1,345 | 38,735 | |||||
Total current liabilities | 29,566 | 74,314 | |||||
Other liabilities, non-current | 3,904 | 3,849 | |||||
Total liabilities | 33,470 | 78,163 | |||||
Stockholders' equity | |||||||
Common stock - Ordinary shares par value £0.001, 701,103,126 authorized and 627,222,076 issued and outstanding (2017: 701,103,126 authorized and 562,119,334 issued and outstanding) | 939 | 854 | |||||
Additional paid in capital | 570,355 | 455,401 | |||||
Accumulated other comprehensive loss | (12,813 | ) | (21,641 | ) | |||
Accumulated deficit | (282,326 | ) | (231,630 | ) | |||
Total stockholders' equity | 276,155 | 202,984 | |||||
Total liabilities and stockholders' equity | $ | 309,625 | $ | 281,147 | |||
Condensed Consolidated Cash Flow Statement
(unaudited, in thousands)
Nine months ended September 30, |
|||||||
2018 | 2017 | ||||||
Cash flows from operating activities | |||||||
Net loss | $ | (59,341 | ) | $ | (42,875 | ) | |
Adjustments to reconcile net loss to net cash used in operating activities: | |||||||
Depreciation | 5,248 | 3,418 | |||||
Amortization | 464 | 267 | |||||
Share-based compensation expense | 12,453 | 7,956 | |||||
Realized loss on available-for-sale debt securities | 2,473 | - | |||||
Unrealized foreign exchange gain (losses) | 4,921 | (6,886 | ) | ||||
Other | 262 | 606 | |||||
Changes in operating assets and liabilities: | |||||||
(Increase) decrease in receivables and other operating assets | (4,140 | ) | 4,180 | ||||
Decrease (increase) in non-current operating assets | 490 | (484 | ) | ||||
(Decrease) increase in payables and deferred revenue | (35,533 | ) | 859 | ||||
Net cash used in operating activities | (72,703 | ) | (32,959 | ) | |||
Cash flows from investing activities | |||||||
Acquisition of property, plant and equipment | (3,823 | ) | (22,791 | ) | |||
Acquisition of intangibles | (666 | ) | (288 | ) | |||
Proceeds from disposal of property, plant and equipment | - | 550 | |||||
Maturity of short-term deposits | - | 40,645 | |||||
Investment in short-term deposits | - | (18,000 | ) | ||||
Maturity or redemption of marketable securities | 114,988 | 7,032 | |||||
Investment in marketable securities | (75,545 | ) | (93,218 | ) | |||
Net cash provided by (used in) investing activities | 34,954 | (86,070 | ) | ||||
Cash flows from financing activities | |||||||
Proceeds from issuance of common stock, net of issuance costs $347 and $4,774 | 99,653 | 103,167 | |||||
Proceeds from exercise of stock options | 2,933 | 401 | |||||
Net cash provided by financing activities | 102,586 | 103,568 | |||||
Effect of currency exchange rate changes on cash, cash equivalents and restricted cash | 4,111 | 2,223 | |||||
Net increase (decrease) in cash, cash equivalents and restricted cash | 68,948 | (13,238 | ) | ||||
Cash, cash equivalents and restricted cash at start of period | 88,296 | 162,796 | |||||
Cash, cash equivalents and restricted cash at end of period | $ | 157,244 | $ | 149,558 | |||
Adaptimmune Contacts:
Media Relations:
Sébastien Desprez – VP, Communications and Investor Relations
T: +44 1235 430 583
M: +44 7718 453 176
Sebastien.Desprez@adaptimmune.com
Investor Relations:
Juli P. Miller, Ph.D. – Director, Investor Relations
T: +1 215 825 9310
M: +1 215 460 8920
Juli.Miller@adaptimmune.com