Full Press Release Details
Adaptimmune Reports Q1 2024 Financial and Business Updates
Afami-cel commercial and regulatory update presented at Company's Investor Day (replay HERE); FDA review and inspections progressing with PDUFA date of August 4th, 2024
Commercial and manufacturing infrastructure in place to support afami-cel commercial launch upon approval
Data from SPEARHEAD-1 pivotal trial with afami-cel published in The Lancet; data from a planned interim analysis of pivotal lete-cel IGNYTE-ESO trial to be presented at ASCO
Cash runway into late 2025
Conference call today at 8 a.m. EDT webcast link HERE
PHILADELPHIA, PA. and OXFORD, UK, May 15, 2024 - Adaptimmune Therapeutics plc (Nasdaq: ADAP), a company redefining the treatment of solid tumor cancers with cell therapy, today reports financial results and business updates for the first quarter ended March 31, 2024. The Company will host a live webcast at 8:00 a.m. EDT (1:00 p.m. BST) today.
Adrian Rawcliffe, Adaptimmune's Chief Executive Officer: "Support from the sarcoma community continues to highlight the high unmet medical need for new therapies for synovial sarcoma and we are making great progress preparing for the commercial launch of afami-cel on approval. Behind afami-cel, we plan to launch lete-cel for synovial sarcoma and MRCLS in 2026 with projected peak US sales of $400 million for our sarcoma franchise."
Sarcoma Franchise with afami-cel and lete-cel
Preclinical pipeline
Financial Results for the three months ended March 31, 2024
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 anticipated revenues from the launch of afami-cel, expected future income from partners and other non-dilutive capital sources including the Company's new debt facility with Hercules Capital announced earlier today, will fund the Company's current operations into late 2025, as further detailed in the Company's Quarterly Report on Form 10-Q for the three months ended March 31, 2024, to be filed with the Securities and Exchange Commission following this earnings release.
Today's Webcast Details
A live webcast and replay can be accessed at https://www.gowebcasting.com/13334. Call in information is as follows: 1-800-806-5484 (US or Canada) or +416-340-2217 (International and additional options available HERE) and the passcode is 3025919#. Callers should dial in 5-10 minutes prior to the scheduled start time and simply ask to join the Adaptimmune call.
Adaptimmune is a clinical-stage biopharmaceutical company focused on designing, developing, and delivering cell therapies to transform the lives of people with cancer. The Company's unique engineered T-cell receptor (TCR) platform enables the engineering of T-cells to target and destroy cancers across multiple solid tumor types.
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 31 December, 2023, 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 thousands):
| March 31, | December 31, | |||||
| 2024 | 2023 | |||||
| Cash and cash equivalents | $ | 140,670 | $ | 143,991 | ||
| Marketable securities - available-for-sale debt securities | 2,982 | 2,947 | ||||
| Total Liquidity | $ | 143,652 | $ | 146,938 |
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 | ||||||
| March 31, | ||||||
| 2024 | 2023 | |||||
| Revenue | $ | 5,678 | $ | 47,601 | ||
| Operating expenses | ||||||
| Research and development | (35,207) | (25,548) | ||||
| General and administrative | (19,732) | (20,397) | ||||
| Total operating expenses | (54,939) | (45,945) | ||||
| Operating (loss)/profit | (49,261) | 1,656 | ||||
| Interest income | 1,345 | 676 | ||||
| Other income (expense), net | (61) | (671) | ||||
| (Loss)/profit before income tax expense | (47,977) | 1,661 | ||||
| Income tax expense | (526) | (625) | ||||
| Net (loss)/profit attributable to ordinary shareholders | $ | (48,503) | $ | 1,036 | ||
| Net (loss)/profit per ordinary share | ||||||
| Basic | $ | (0.03) | $ | 0.00 | ||
| Diluted | $ | (0.03) | $ | 0.00 | ||
| Weighted average shares outstanding: | ||||||
| Basic | 1,451,241,661 | 991,330,402 | ||||
| Diluted | 1,451,241,661 | 1,000,276,615 |
Condensed Consolidated Balance Sheets
(unaudited, in thousands, except share data)
| March 31, | December 31, | |||||
| 2024 | 2023 | |||||
| Assets | ||||||
| Current assets | ||||||
| Cash and cash equivalents | $ | 140,670 | $ | 143,991 | ||
| Marketable securities - available-for-sale debt securities (amortized cost of $2,981 and $2,940) net of allowance for expected credit losses of $0 and $0 | 2,982 | 2,947 | ||||
| Accounts receivable, net of allowance for expected credit losses of $0 and $0 | 8,404 | 821 | ||||
| Other current assets and prepaid expenses | 34,847 | 59,793 | ||||
| Total current assets | 186,903 | 207,552 | ||||
| Restricted cash | 2,858 | 3,026 | ||||
| Operating lease right-of-use assets, net of accumulated amortization of $14,381 and $13,220 | 19,434 | 20,762 | ||||
| Property, plant and equipment, net of accumulated depreciation of $48,445 and $46,020 | 48,291 | 50,946 | ||||
| Intangible assets, net of accumulated amortization of $5,198 and $5,155 | 524 | 330 | ||||
| Total assets | $ | 258,010 | $ | 282,616 | ||
| Liabilities and stockholders' equity | ||||||
| Current liabilities | ||||||
| Accounts payable | $ | 6,587 | $ | 8,128 | ||
| Operating lease liabilities, current | 5,250 | 5,384 | ||||
| Accrued expenses and other current liabilities | 23,050 | 30,303 | ||||
| Deferred revenue, current | 31,524 | 28,973 | ||||
| Total current liabilities | 66,411 | 72,788 | ||||
| Operating lease liabilities, non-current | 18,442 | 19,851 | ||||
| Deferred revenue, non-current | 147,365 | 149,060 | ||||
| Other liabilities, non-current | 1,417 | 1,404 | ||||
| Total liabilities | 233,635 | 243,103 | ||||
| Stockholders' equity | ||||||
| Common stock - Ordinary shares par value 0.001, 1,702,760,280 authorized and 1,532,974,878 issued and outstanding (2023: 1,702,760,280 authorized and 1,363,008,102 issued and outstanding) | 2,081 | 1,865 | ||||
| Additional paid in capital | 1,096,690 | 1,064,569 | ||||
| Accumulated other comprehensive loss | (2,720) | (3,748) | ||||
| Accumulated deficit | (1,071,676) | (1,023,173) | ||||
| Total stockholders' equity | 24,375 | 39,513 | ||||
| Total liabilities and stockholders' equity | $ | 258,010 | $ | 282,616 |
Condensed Consolidated Cash Flow Statement
(unaudited, in thousands)
| Three months ended | ||||||
| March 31, | ||||||
| 2024 | 2023 | |||||
| Cash flows from operating activities | ||||||
| Net (loss)/profit | $ | (48,503) | $ | 1,036 | ||
| Adjustments to reconcile net loss to net cash used in operating activities: | ||||||
| Depreciation | 2,771 | 1,659 | ||||
| Amortization | 59 | 186 | ||||
| Share-based compensation expense | 3,102 | 1,676 | ||||
| Unrealized foreign exchange losses | 305 | 563 | ||||
| (Accretion)/amortization on available-for-sale debt securities | (23) | 112 | ||||
| Other | (19) | 134 | ||||
| Changes in operating assets and liabilities: | ||||||
| Increase in receivables and other operating assets | 15,620 | 3,683 | ||||
| (Decrease)/increase in payables and other current liabilities | (7,650) | 21 | ||||
| Decrease/(increase) in deferred revenue | 2,388 | (46,353) | ||||
| Net cash used in operating activities | (31,950) | (37,283) | ||||
| Cash flows from investing activities | ||||||
| Acquisition of property, plant and equipment | (102) | (2,349) | ||||
| Acquisition of intangible assets | (256) | (173) | ||||
| Maturity or redemption of marketable securities | - | 50,863 | ||||
| Net cash (used in)/provided by investing activities | (358) | 48,341 | ||||
| Cash flows from financing activities | ||||||
| Proceeds from issuance of common stock from offerings, net of commissions and issuance costs | 29,161 | 188 | ||||
| Proceeds from exercise of stock options | 74 | 8 | ||||
| Net cash provided by financing activities | 29,235 | 196 | ||||
| Effect of currency exchange rate changes on cash, cash equivalents and restricted cash | (416) | 588 | ||||
| Net (decrease)/increase in cash, cash equivalents and restricted cash | (3,489) | 11,842 | ||||
| Cash, cash equivalents and restricted cash at start of period | 147,017 | 109,602 | ||||
| Cash, cash equivalents and restricted cash at end of period | $ | 143,528 | $ | 121,444 |
Juli P. Miller, Ph.D. - VP, Corporate Affairs and Investor Relations
Dana Lynch, Senior Director of Corporate Communications