Full Press Release Details
Adaptimmune Reports Second-Quarter Financial Results and Business Update
- Reaffirming financial guidance; Company funded into early 2024 -
- ASCO data confirms afami-cel potential for synovial sarcoma; BLA submission on-track for Q4 2022 -
- Update from signal-finding Phase 1 SURPASS trial at the September ESMO 2022 Congress -
- Quarterly call to be held today, August 4, 2022, at 8:00 a.m. EDT (1:00 p.m. BST) -
PHILADELPHIA, PA. and OXFORD, UK, August 4, 2022 - Adaptimmune Therapeutics plc (Nasdaq: ADAP), a leader in cell therapy to treat cancer, today reported financial results for the second quarter ended June 30, 2022 and provided a business update. For the three months ended June 30, 2022, Revenue was $5.5 million, Total Operating Expenses (Research and Development and General and Administrative) were $49.3 million, and Net Loss was $44.5 million.
"We continue to demonstrate progress with our four focus areas for 2022: submitting our BLA for afami-cel, building a MAGE-A4 franchise, scaling up manufacturing capabilities, and advancing our allogeneic platform, pipeline and collaborations," said Adrian Rawcliffe, Adaptimmune's Chief Executive Officer. "The data presented at ASCO further confirm the potential of afami-cel for the initial indication of synovial sarcoma with the BLA submission on-track for Q4 this year. To support commercialization of afami-cel and other products both near- and longer-term, we are investing in focused but scalable operational infrastructure to set us up for success. At the same time, we are carefully monitoring market conditions. We will continue to prudently manage expenses and stop or delay non-core activities."
Adaptimmune's first potential commercial product, afami-cel, supported by positive data readouts
Biologics License Application (BLA) submission for afami-cel on track for Q4 2022
Adaptimmune is preparing its BLA and continues to target submission to the U.S. Food and Drug Administration (FDA) in the fourth-quarter 2022 for the treatment of synovial sarcoma. This BLA is supported by data from Cohort 1 of the pivotal trial SPEARHEAD-1, which met its primary endpoint for efficacy. In addition, the Company has the following progress updates:
Afami-cel presentation at ASCO 2022 - responses reported across all patient subgroups
As reported in June, data based on pooled analyses of characteristics associated with clinical responses (per investigator assessment) from both Cohort 1 of the SPEARHEAD-1 trial, as well as the Phase 1 trial of afami-cel in patients with advanced synovial sarcoma or myxoid/round cell liposarcoma (MRCLS), were presented at the American Society for Clinical Oncology (ASCO)
Potential of next-gen MAGE-A4 targeted cell therapy in multiple solid tumors
Phase 1 signal-finding SURPASS trial update at ESMO in September
Corporate and other news
Financial Results for the three and six months ended June 30, 2022
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
The Company believes that its existing cash, cash equivalents and marketable securities, together with the additional payments under the Strategic Collaboration and License Agreement with Genentech, will fund the Company's current operations into early 2024, as further detailed in the Company's Quarterly Report on Form 10-Q for the three and six months ended June 30, 2022, 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 8:00 a.m. EDT (1:00 p.m. BST) today, August 4, 2022. A live webcast of the conference call and replay can be accessed at https://www.gowebcasting.com/12004. Call in information is as follows: (800)-952-5114 (US or Canada) or +1 (416)-406-0743 (International and additional options available HERE). After placing the call, please ask to be joined into the Adaptimmune conference call and provide the confirmation code (5869059).
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.
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 for
the year ended December 31, 2021, our Quarterly Reports on Form 10-Q, Current Reports on Form 8-K, and other filings with the Securities and Exchange Commission. 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, | |||||
| 2022 | 2021 | |||||
| Cash and cash equivalents | $ | 97,811 | $ | 149,948 | ||
| Marketable securities - available-for-sale debt securities | 160,278 | 219,632 | ||||
| Total Liquidity | $ | 258,089 | $ | 369,580 |
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 solvency and liquidity, financial flexibility, capital position and leverage.
Condensed Consolidated Statement of Operations
(unaudited, in thousands, except per share data)
| Three months ended | Six months ended | ||||||||||||
| June 30, | June 30, | ||||||||||||
| 2022 | 2021 | 2022 | 2021 | ||||||||||
| Revenue | $ | 5,538 | $ | 3,095 | $ | 9,113 | $ | 3,529 | |||||
| Operating expenses | |||||||||||||
| Research and development | (34,740) | (28,868) | (71,492) | (53,374) | |||||||||
| General and administrative | (14,550) | (13,539) | (31,354) | (27,356) | |||||||||
| Total operating expenses | (49,290) | (42,407) | (102,846) | (80,730) | |||||||||
| Operating loss | (43,752) | (39,312) | (93,733) | (77,201) | |||||||||
| Interest income | 357 | 266 | 695 | 691 | |||||||||
| Other income (expense), net | (655) | 54 | (643) | 53 | |||||||||
| Loss before income tax expense | (44,050) | (38,992) | (93,681) | (76,457) | |||||||||
| Income tax expense | (470) | (76) | (1,104) | (374) | |||||||||
| Net loss attributable to ordinary shareholders | $ | (44,520) | $ | (39,068) | $ | (94,785) | $ | (76,831) | |||||
| Net loss per ordinary share | |||||||||||||
| Basic and diluted | $ | (0.05) | $ | (0.04) | $ | (0.10) | $ | (0.08) | |||||
| Weighted average shares outstanding: | |||||||||||||
| Basic and diluted | 962,794,072 | 934,228,095 | 951,474,546 | 932,667,125 |
Condensed Consolidated Balance Sheets
(unaudited, in thousands, except share data)
| June 30, | December 31, | |||||
| 2022 | 2021 | |||||
| Assets | ||||||
| Current assets | ||||||
| Cash and cash equivalents | $ | 97,811 | $ | 149,948 | ||
| Marketable securities - available-for-sale debt securities | 160,278 | 219,632 | ||||
| Accounts receivable, net of allowance for doubtful accounts of $0 and $0 | 2,382 | 752 | ||||
| Other current assets and prepaid expenses | 60,694 | 45,126 | ||||
| Total current assets | 321,165 | 415,458 | ||||
| Restricted cash | 1,713 | 1,718 | ||||
| Operating lease right-of-use assets, net of accumulated amortization | 19,380 | 20,875 | ||||
| Property, plant and equipment, net of accumulated depreciation of $36,073 and $36,253 | 45,400 | 30,494 | ||||
| Intangible assets, net of accumulated amortization of $4,287 and $4,051 | 612 | 1,000 | ||||
| Total assets | $ | 388,270 | $ | 469,545 | ||
| Liabilities and stockholders' equity | ||||||
| Current liabilities | ||||||
| Accounts payable | $ | 15,991 | $ | 8,113 | ||
| Operating lease liabilities, current | 2,557 | 2,320 | ||||
| Accrued expenses and other current liabilities | 32,616 | 29,909 | ||||
| Deferred revenue, current | 22,468 | 22,199 | ||||
| Total current liabilities | 73,632 | 62,541 | ||||
| Operating lease liabilities, non-current | 21,635 | 23,148 | ||||
| Deferred revenue, non-current | 150,437 | 177,223 | ||||
| Other liabilities, non-current | 649 | 673 | ||||
| Total liabilities | 246,353 | 263,585 | ||||
| Stockholders' equity | ||||||
| Common stock - Ordinary shares par value 0.001, 1,282,773,750 authorized and 976,759,524 issued and outstanding (2021: 1,240,853,520 authorized and 937,547,934 issued and outstanding) | 1,387 | 1,337 | ||||
| Additional paid in capital | 980,204 | 959,611 | ||||
| Accumulated other comprehensive loss | (1,043) | (11,142) | ||||
| Accumulated deficit | (838,631) | (743,846) | ||||
| Total stockholders' equity | 141,917 | 205,960 | ||||
| Total liabilities and stockholders' equity | $ | 388,270 | $ | 469,545 |
Condensed Consolidated Cash Flow Statement
(unaudited, in thousands)
| Six months ended | ||||||
| June 30, | ||||||
| 2022 | 2021 | |||||
| Cash flows from operating activities | ||||||
| Net loss | $ | (94,785) | $ | (76,831) | ||
| Adjustments to reconcile net loss to net cash used in operating activities: | ||||||
| Depreciation | 2,728 | 2,879 | ||||
| Amortization | 419 | - | ||||
| Share-based compensation expense | 10,631 | 10,783 | ||||
| Unrealized foreign exchange gains | (108) | (267) | ||||
| Amortization on available-for-sale debt securities | 1,636 | 2,884 | ||||
| Other | 585 | 1,401 | ||||
| Changes in operating assets and liabilities: | ||||||
| Increase in receivables and other operating assets | (22,898) | (21,457) | ||||
| Increase in payables and other current liabilities | 12,898 | 663 | ||||
| (Decrease)/ increase in deferred revenue | (6,758) | 1,946 | ||||
| Net cash used in operating activities | (95,652) | (77,999) | ||||
| Cash flows from investing activities | ||||||
| Acquisition of property, plant and equipment | (16,074) | (2,924) | ||||
| Acquisition of intangible assets | - | (143) | ||||
| Maturity or redemption of marketable securities | 97,605 | 154,465 | ||||
| Investment in marketable securities | (42,197) | (81,958) | ||||
| Net cash provided by investing activities | 39,334 | 69,440 | ||||
| Cash flows from financing activities | ||||||
| Proceeds from issuance of common stock from offerings, net of commissions and issuance costs | 9,976 | 2,519 | ||||
| Proceeds from exercise of stock options | 36 | 578 | ||||
| Net cash provided by financing activities | 10,012 | 3,097 | ||||
| Effect of currency exchange rate changes on cash, cash equivalents and restricted cash | (5,836) | (937) | ||||
| Net decrease in cash, cash equivalents and restricted cash | (52,142) | (6,399) | ||||
| Cash, cash equivalents and restricted cash at start of period | 151,666 | 61,484 | ||||
| Cash, cash equivalents and restricted cash at end of period | $ | 99,524 | $ | 55,085 |
Investor and Media Relations
Juli P. Miller, Ph.D. - VP, Corporate Affairs and Investor Relations