Full Press Release Details
Adaptimmune Reports Second Quarter Financial Results and Business Update
- SPEARHEAD-1 data presented at ASCO with overall response rate of 39.3% in synovial sarcoma and MRCLS; on track to file BLA for afami-cel next year -
- SURPASS trial data from 23 evaluable patients to be presented at ESMO -
- ADP-A2AFP Phase 1 trial data from 11 evaluable patients in Group 3/Expansion to be presented at ILCA -
- Financial guidance confirmed: funded into early 2023 -
- Conference call to be held today at 4:30 p.m. EDT (9:30 p.m. BST) -
PHILADELPHIA, PA. and OXFORD, UK, August 9, 2021 - Adaptimmune Therapeutics plc (Nasdaq: ADAP), a leader in cell therapy to treat cancer, today reported financial results for the second quarter ended June 30, 2021 and provided a business update.
"With the data presented at ASCO for afami-cel and our planned BLA filing next year, I am pleased with progress on our 2-2-5-2' strategy," said Adrian Rawcliffe, Adaptimmune's Chief Executive Officer. "We will present data updates from our Phase 1 trials, SURPASS and ADP-A2AFP, at upcoming conferences and I am confident that Adaptimmune is well-placed to maintain its leadership position in cell therapies for cancer."
Upcoming confirmed data updates
ADP-A2AFP Phase 1 Trial at ILCA
SURPASS Phase 1 Trial at ESMO
SPEARHEAD-1 and afami-cel BLA
Further indications for next-gen SPEAR T-cell therapies
Other early-stage programs
Financial Results for the three and six months ended June 30, 2021
The Company believes that its existing cash, cash equivalents and marketable securities will fund the Company's current operations into early 2023, as further detailed in the Company's Quarterly Report on Form 10-Q for the three and six months ended June 30, 2021, to be filed with the Securities and Exchange Commission following this earnings release.
Conference Call Information
The Company will host a live teleconference and webcast to provide additional details at 4:30 p.m. EDT (9:30 p.m. BST) today. A live webcast of the conference call and replay can be accessed at https://bit.ly/3zFas59. An archive will be available after the call at the same address. To participate in the live conference call, if preferred, please dial (833) 652-5917 (US 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 (7867634).
Adaptimmune is a clinical-stage biopharmaceutical company focused on the development of novel cancer immunotherapy products for people with cancer. 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.
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.
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 May 6, 2021 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 (available-for-sale debt securities). Each of these components appears separately in the condensed consolidated balance sheet. The U.S. GAAP financial measure most directly comparable to Total Liquidity is cash and cash equivalents as reported in the condensed consolidated financial statements, which reconciles to Total Liquidity as follows (in millions):
| June 30, | December 31, | |||||
| 2021 | 2020 | |||||
| Cash and cash equivalents | $ | 50,453 | $ | 56,882 | ||
| Marketable securities - available-for-sale debt securities | 234,917 | 311,335 | ||||
| Total Liquidity | $ | 285,370 | $ | 368,217 |
The Company believes that the presentation of Total Liquidity provides useful information to investors because management reviews Total Liquidity as part of its assessment of overall liquidity, financial flexibility, capital structure and leverage.
Condensed Consolidated Statement of Operations
(unaudited, in thousands, except per share data)
| Three months ended | Six months ended | ||||||||||||
| June 30, | June 30, | ||||||||||||
| 2021 | 2020 | 2021 | 2020 | ||||||||||
| Revenue | $ | 3,095 | $ | 502 | $ | 3,529 | $ | 1,263 | |||||
| Operating expenses | |||||||||||||
| Research and development | (28,868) | (20,460) | (53,374) | (41,724) | |||||||||
| General and administrative | (13,539) | (10,295) | (27,356) | (19,556) | |||||||||
| Total operating expenses | (42,407) | (30,755) | (80,730) | (61,280) | |||||||||
| Operating loss | (39,312) | (30,253) | (77,201) | (60,017) | |||||||||
| Interest income | 266 | 1,147 | 691 | 1,877 | |||||||||
| Other income (expense), net | 54 | (749) | 53 | 188 | |||||||||
| Loss before income taxes | (38,992) | (29,855) | (76,457) | (57,952) | |||||||||
| Income taxes | (76) | (25) | (374) | (95) | |||||||||
| Net loss attributable to ordinary shareholders | $ | (39,068) | $ | (29,880) | $ | (76,831) | $ | (58,047) | |||||
| Net loss per ordinary share | |||||||||||||
| Basic and diluted | $ | (0.04) | $ | (0.04) | $ | (0.08) | $ | (0.07) | |||||
| Weighted average shares outstanding: | |||||||||||||
| Basic and diluted | 934,228,095 | 822,725,556 | 932,667,125 | 781,235,457 |
Condensed Consolidated Balance Sheets
(unaudited, in thousands, except share data)
| June 30, | December 31, | |||||
| 2021 | 2020 | |||||
| Assets | ||||||
| Current assets | ||||||
| Cash and cash equivalents | $ | 50,453 | $ | 56,882 | ||
| Marketable securities - available-for-sale debt securities | 234,917 | 311,335 | ||||
| Accounts receivable, net of allowance for doubtful accounts of $0 and $0 | 2,158 | 139 | ||||
| Other current assets and prepaid expenses | 49,816 | 29,796 | ||||
| Total current assets | 337,344 | 398,152 | ||||
| Restricted cash | 4,632 | 4,602 | ||||
| Operating lease right-of-use assets, net of accumulated amortization | 17,772 | 18,880 | ||||
| Property, plant and equipment, net of accumulated depreciation of $34,360 (2020: $31,097) | 28,663 | 27,778 | ||||
| Intangibles, net of accumulated amortization | 1,382 | 1,730 | ||||
| Total assets | $ | 389,793 | $ | 451,142 | ||
| Liabilities and stockholders' equity | ||||||
| Current liabilities | ||||||
| Accounts payable | $ | 6,977 | $ | 6,389 | ||
| Operating lease liabilities, current | 2,922 | 2,773 | ||||
| Accrued expenses and other accrued liabilities | 26,606 | 27,079 | ||||
| Deferred revenue, current | 4,911 | 2,832 | ||||
| Total current liabilities | 41,416 | 39,073 | ||||
| Operating lease liabilities, non-current | 19,723 | 20,938 | ||||
| Deferred revenue, non-current | 50,048 | 49,260 | ||||
| Other liabilities, non-current | 667 | 644 | ||||
| Total liabilities | 111,854 | 109,915 | ||||
| Stockholders' equity | ||||||
| Common stock - Ordinary shares par value 0.001, 1,240,853,520 authorized and 936,237,126 issued and outstanding (2020: 1,038,249,630 authorized and 928,754,958 issued and outstanding) | 1,336 | 1,325 | ||||
| Additional paid in capital | 949,575 | 935,706 | ||||
| Accumulated other comprehensive loss | (10,385) | (10,048) | ||||
| Accumulated deficit | (662,587) | (585,756) | ||||
| Total stockholders' equity | 277,939 | 341,227 | ||||
| Total liabilities and stockholders' equity | $ | 389,793 | $ | 451,142 |
Condensed Consolidated Cash Flow Statement
(unaudited, in thousands)
| Six months ended | |||||||
| June 30, | |||||||
| 2021 | 2020 | ||||||
| Cash flows from operating activities | |||||||
| Net loss | $ | (76,831) | $ | (58,047) | |||
| Adjustments to reconcile net loss to net cash used in operating activities: | |||||||
| Depreciation | 2,879 | 3,583 | |||||
| Share-based compensation expense | 10,783 | 4,072 | |||||
| Unrealized foreign exchange gains | (267) | (2,004) | |||||
| Amortization on available-for-sale debt securities | 2,884 | 702 | |||||
| Other | 1,401 | 480 | |||||
| Changes in operating assets and liabilities: | |||||||
| Increase in receivables and other operating assets | (21,457) | (10,104) | |||||
| Decrease in non-current operating assets | - | 615 | |||||
| Increase in payables and other current liabilities | 663 | 3,571 | |||||
| Increase in deferred revenue | 1,946 | 49,074 | |||||
| Net cash used in operating activities | (77,999) | (8,058) | |||||
| Cash flows from investing activities | |||||||
| Acquisition of property, plant and equipment | (2,924) | (460) | |||||
| Acquisition of intangibles | (143) | (407) | |||||
| Maturity or redemption of marketable securities | 154,465 | 39,931 | |||||
| Investment in marketable securities | (81,958) | (298,016) | |||||
| Net cash provided by (used in) investing activities | 69,440 | (258,952) | |||||
| Cash flows from financing activities | |||||||
| Proceeds from issuance of common stock from offerings, net of commissions and issuance costs | 2,519 | 334,388 | |||||
| Proceeds from exercise of stock options | 578 | 5,075 | |||||
| Net cash provided by financing activities | 3,097 | 339,463 | |||||
| Effect of currency exchange rate changes on cash, cash equivalents and restricted cash | (937) | (678) | |||||
| Net (decrease) increase in cash, cash equivalents and restricted cash | (6,399) | 71,775 | |||||
| Cash, cash equivalents and restricted cash at start of period | 61,484 | 54,908 | |||||
| Cash, cash equivalents and restricted cash at end of period | $ | 55,085 | $ | 126,683 |
Adaptimmune Contacts:
S bastien Desprez - VP, Corporate Affairs and Communications
Juli P. Miller, Ph.D. - VP, Investor Relations