Full Press Release Details
Adaptimmune Reports Third Quarter 2019
Financial Results and Business Update
- Clinical responses with ADP-A2M4 in 7
out of 12 patients with synovial sarcoma, and clinical benefit in 11 out of 12 patients -
- ADP-A2M4 granted Orphan Drug Designation
for treatment of soft tissue sarcomas -
- Enrolling across SPEARHEAD-1 and SURPASS
trials at multiple sites -
- Progress towards commercializing ADP-A2M4
for patients with synovial sarcoma in 2022 -
- Progressed to third cohort in ADP-A2AFP
trial in liver cancer -
- Michael Garone appointed as Interim Chief
- Financial guidance confirmed: funded through
- Conference call to be held today at 8:00
a.m. EST (1:00 p.m. GMT) -
PHILADELPHIA, PA., and OXFORDSHIRE, U.K., November 6, 2019 (GLOBE
NEWSWIRE) -- Adaptimmune Therapeutics plc (Nasdaq:ADAP), a leader in T-cell therapy to treat cancer, today reported financial results
and business highlights from Q3 2019.
"The sarcoma community has been very supportive following
the ESMO presentation in which we showed a clear benefit for ADP-A2M4. This increases our confidence that we can accelerate enrollment
in SPEARHEAD-1 as we progress toward commercialization in 2022," said Adrian Rawcliffe, Adaptimmune's Chief Executive
Officer. "We continue to see evidence of antitumor activity with our SPEAR T-cells across other indications. We are executing
with our ADP-A2AFP trial, now dosing in Cohort 3, as well as our next-gen SURPASS trial, and we plan on updating data throughout
2020. We continue to prioritize resources to enable us to deliver data from our ongoing trials."
COMMERCIAL READINESSS FOR ADP-A2M4 IN SARCOMA WITH AIM TO
FOCUSED ON EXECUTION IN OTHER CLINICAL TRIALS
| Enrolling in Cohort 3 in the ADP-A2AFP trial in liver cancer at target doses of 5 billion SPEAR T-cells (range 1.2 to 6 billion), after Safety Review Committee endorsed dose escalation | ||
| Continuing enrollment in the radiation sub-study of the Phase 1 ADP-A2M4 trial |
Preclinical progress
Other corporate news
Financial Results for the three-month period ended September
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.
The Company believes that its existing cash, cash equivalents
and marketable securities will fund the Company's current operations through the third quarter of 2020. As further detailed
in the Company's Quarterly Report on Form 10-Q for the fiscal quarter ended September 30, 2019, to be filed with the Securities
and Exchange Commission following this earnings release, the Company has evaluated whether there are conditions and events, considered
in the aggregate, that raise substantial doubt about the Company's ability to continue as a going concern within one year
after the date the financial statements are issued. The Company concluded that there are factors that raise substantial doubt about
its ability to continue as a going concern for at least one year from the issuance of the September 30, 2019 quarterly condensed
consolidated financial statements. In the immediate future, the Company plans to continue to prioritize and review ongoing clinical
development projects and costs with the aim of focusing operations on the ADP-A2M4 SPEARHEAD-1, ADP-A2M4CD8 SURPASS, and ADP-A2AFP
trials. The Company believes that a combination of targeted clinical progress together with accessing additional capital and/or
cost reductions will enable the Company to continue as a going concern for the next twelve months. The Company's financial
results are presented as though it would continue as a going concern.
Call and Webcast Information
The Company will host a live teleconference
at 8:00 a.m. EST (1:00 p.m. GMT)
today, November 6, 2019. The
live webcast of the conference call will be available in the investor section 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 Canada) 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 (3997944).
Adaptimmune is a clinical-stage biopharmaceutical company focused
on the development of novel cancer immunotherapy products for cancer patients. The Company's unique SPEAR (Specific Peptide
Enhanced Affinity Receptor) T-cell platform enables the engineering
of T-cells to target and destroy cancer across multiple solid tumors. 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 1, 2019 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 (a non-GAAP financial measure) 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):
| September 30, | December 31, | |||||||
| 2019 | 2018 | |||||||
| Cash and cash equivalents | $ | 39,409 | $ | 68,379 | ||||
| Marketable securities | 63,451 | 136,755 | ||||||
| Total Liquidity | $ | 102,860 | $ | 205,134 |
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 | Nine months ended | |||||||||||||||
| September 30, | September 30, | |||||||||||||||
| 2019 | 2018 | 2019 | 2018 | |||||||||||||
| Development revenue | 237 | 1,678 | 394 | 18,912 | ||||||||||||
| License revenue | - | 39,114 | - | 39,114 | ||||||||||||
| Total revenue | $ | 237 | $ | 40,792 | $ | 394 | $ | 58,026 | ||||||||
| Operating expenses | ||||||||||||||||
| Research and development (including losses accrued on firm purchase commitments of $5,000, $-, $5,000 and $-) | (29,617 | ) | (23,484 | ) | (77,147 | ) | (75,500 | ) | ||||||||
| General and administrative | (10,741 | ) | (10,290 | ) | (32,662 | ) | (32,785 | ) | ||||||||
| Total operating expenses | (40,358 | ) | (33,774 | ) | (109,809 | ) | (108,285 | ) | ||||||||
| Operating (loss) income | (40,121 | ) | 7,018 | (109,415 | ) | (50,259 | ) | |||||||||
| Interest income | 615 | 606 | 2,324 | 1,805 | ||||||||||||
| Other income (expense), net | 291 | (2,249 | ) | (556 | ) | (10,525 | ) | |||||||||
| (Loss) income before income taxes | (39,215 | ) | 5,375 | (107,647 | ) | (58,979 | ) | |||||||||
| Income taxes | (87 | ) | (133 | ) | (154 | ) | (362 | ) | ||||||||
| Net (loss) income attributable to ordinary shareholders | $ | (39,302 | ) | $ | 5,242 | $ | (107,801 | ) | $ | (59,341 | ) | |||||
| Net (loss) income per ordinary share - Basic and diluted | ||||||||||||||||
| Basic | $ | (0.06 | ) | $ | 0.01 | $ | (0.17 | ) | $ | (0.10 | ) | |||||
| Diluted | (0.06 | ) | 0.01 | (0.17 | ) | (0.10 | ) | |||||||||
| Weighted average shares outstanding: | ||||||||||||||||
| Basic | 630,866,800 | 582,004,954 | 629,403,293 | 573,796,275 | ||||||||||||
| Diluted | 630,866,800 | 621,764,201 | 629,403,293 | 573,796,275 |
Condensed Consolidated Balance Sheets
(unaudited, in thousands, except share data)
| September 30, | December 31, | |||||||
| 2019 | 2018 | |||||||
| Assets | ||||||||
| Current assets | ||||||||
| Cash and cash equivalents | $ | 39,409 | $ | 68,379 | ||||
| Marketable securities - available-for-sale debt securities | 63,451 | 136,755 | ||||||
| Accounts receivable, net of allowance for doubtful accounts of $0 and $0 | - | 192 | ||||||
| Other current assets and prepaid expenses (including current portion of clinical materials) | 44,110 | 25,769 | ||||||
| Total current assets | 146,970 | 231,095 | ||||||
| Restricted cash | 4,318 | 4,097 | ||||||
| Clinical materials | 2,485 | 3,953 | ||||||
| Operating lease right-of-use assets, net of accumulated amortization | 20,563 | - | ||||||
| Property, plant and equipment, net of accumulated depreciation of $20,818 (2018: $15,924) | 31,641 | 36,118 | ||||||
| Intangibles, net of accumulated amortization | 2,274 | 1,473 | ||||||
| Total assets | $ | 208,251 | $ | 276,736 | ||||
| Liabilities and stockholders' equity | ||||||||
| Current liabilities | ||||||||
| Accounts payable | 5,535 | 4,083 | ||||||
| Operating lease liabilities, current | 2,337 | - | ||||||
| Accrued expenses and other accrued liabilities | 26,846 | 20,354 | ||||||
| Deferred revenue | 2,683 | - | ||||||
| Total current liabilities | 37,401 | 24,437 | ||||||
| Operating lease liabilities, non-current | 22,599 | - | ||||||
| Other liabilities, non-current | 568 | 5,414 | ||||||
| Total liabilities | 60,568 | 29,851 | ||||||
| Stockholders' equity | ||||||||
| Common stock - Ordinary shares par value 0.001, 785,857,300 authorized and 630,952,736 issued and outstanding (2018: 701,103,126 authorized and 627,454,270 issued and outstanding) | 943 | 939 | ||||||
| Additional paid in capital | 583,065 | 574,208 | ||||||
| Accumulated other comprehensive loss | (10,025 | ) | (9,763 | ) | ||||
| Accumulated deficit | (426,300 | ) | (318,499 | ) | ||||
| Total stockholders' equity | 147,683 | 246,885 | ||||||
| Total liabilities and stockholders' equity | $ | 208,251 | $ | 276,736 |
Condensed Consolidated Cash Flow Statement
(unaudited, in thousands)
| Nine months ended | ||||||||
| September 30, | ||||||||
| 2019 | 2018 | |||||||
| Cash flows from operating activities | ||||||||
| Net loss | $ | (107,801 | ) | $ | (59,341 | ) | ||
| Adjustments to reconcile net loss to net cash used in operating activities: | ||||||||
| Depreciation | 5,406 | 5,248 | ||||||
| Amortization | 511 | 464 | ||||||
| Share-based compensation expense | 8,495 | 12,453 | ||||||
| Realized (gain) loss on available-for-sale debt securities | (13 | ) | 2,473 | |||||
| Unrealized foreign exchange losses | 522 | 4,921 | ||||||
| Other | (195 | ) | 262 | |||||
| Changes in operating assets and liabilities: | ||||||||
| Increase in receivables and other operating assets | (20,075 | ) | (4,140 | ) | ||||
| Decrease in non-current operating assets | 1,468 | 490 | ||||||
| Increase (decrease) in payables and deferred revenue | 11,703 | (35,533 | ) | |||||
| Net cash used in operating activities | (99,979 | ) | (72,703 | ) | ||||
| Cash flows from investing activities | ||||||||
| Acquisition of property, plant and equipment | (1,425 | ) | (3,823 | ) | ||||
| Acquisition of intangibles | (1,036 | ) | (666 | ) | ||||
| Maturity or redemption of marketable securities | 92,803 | 114,988 | ||||||
| Investment in marketable securities | (19,080 | ) | (75,545 | ) | ||||
| Net cash provided by investing activities | 71,262 | 34,954 | ||||||
| Cash flows from financing activities | ||||||||
| Proceeds from issuance of common stock, net of issuance costs of $0 and $347 | - | 99,653 | ||||||
| Proceeds from exercise of stock options | 366 | 2,933 | ||||||
| Net cash provided by financing activities | 366 | 102,586 | ||||||
| Effect of currency exchange rate changes on cash, cash equivalents and restricted cash | (398 | ) | 4,111 | |||||
| Net (decrease) increase in cash and cash equivalents | (28,749 | ) | 68,948 | |||||
| Cash, cash equivalents and restricted cash at start of period | 72,476 | 88,296 | ||||||
| Cash, cash equivalents and restricted cash at end of period | $ | 43,727 | $ | 157,244 |
Adaptimmune Contacts:
S bastien Desprez - VP, Communications and Investor
Juli P. Miller, Ph.D. - Senior Director, Investor Relations