Full Press Release Details
Adaptimmune Reports Q3 2024 Financial and Business Updates
Tecelra launch on track with 9 Authorized Treatment Centers available to initiate patient treatment journey, and the first patient apheresed in Q3; expect first commercial revenues in Q4 and the number of treated patients to accelerate throughout 2025
Lete-cel IGNYTE-ESO pivotal trial primary analysis reports 42% overall response rate in synovial sarcoma and myxoid/round cell liposarcoma (MRCLS); full data at CTOS conference on November 16
Company restructuring to prioritize commercial sarcoma franchise and R&D programs with highest potential return on invested capital and transformational benefit to patients
Planned 33% reduction in headcount in Q1, 2025 as part of approximately $300 million in aggregate cost savings over the next four years enables company to target an operating breakeven during 2027
At the end of Q3, Adaptimmune had Total Liquidity1 of $186.1 million
PHILADELPHIA, PA. and OXFORD, UK, November 13, 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 third quarter ended September 30, 2024. The Company will host a live webcast at 4:30 p.m. EST (9:30 p.m. GMT) today.
Adrian Rawcliffe, Adaptimmune's Chief Executive Officer: "With Tecelra's encouraging launch and the new positive pivotal results for lete-cel to be presented at CTOS, Adaptimmune will redefine itself as a sarcoma-focused business. We have increased confidence in our $400 million peak year sales estimate for the combined sarcoma franchise. We're creating a new leaner company, investing in only the highest potential programs and reducing our operating expenses by around $300 million over the next four years. With these actions we have a clear path to operating breakeven during 2027."
Company focuses on strategic business plan and restructuring
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
Lete-cel registrational data (details are in a separate press release issued today)
Full primary analysis on 64 patients with long term follow up from pivotal IGNYTE-ESO trial has been completed and will be presented at the Connective Tissue Oncology Society (CTOS) annual meeting, being held in San Diego, CA from November 13 to 16, 2024:
Recent data presentations
Today's Webcast Details
A live webcast and replay can be accessed at https://www.gowebcasting.com/13698. Call in information is as follows: +1-844-763-8274 (US or Canada) or +1-647-484-8814 (International). Callers should dial in 10 minutes prior to the scheduled start time and simply ask to join the Adaptimmune call.
Virtual KOL Webcast Details November 18th following CTOS
Join Adaptimmune on Monday, November 18, 2024 at 2:30 PM ET for a virtual KOL event featuring Dr. Sandra D'Angelo, M.D. (Memorial Sloan Kettering Cancer Center) who will discuss the unmet need and current treatment landscape for patients with sarcoma, including synovial sarcoma (SyS) and myxoid/round cell liposarcoma (MRCLS).Register & Attend: Adaptimmune Virtual KOL Event - LifeSci Events
Financial Results for the three and nine months ended September 30, 2024
Adaptimmune is a fully integrated cell therapy company working to redefine how cancer is treated. With its unique engineered T cell receptor (TCR) platform, the Company is developing personalized medicines designed to target and destroy difficult-to-treat solid tumor cancers and to radically improve the patient's cancer treatment experience.
2 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 safe harbor provisions of Section 27A of the Securities Act and Section 21E of the Securities Exchange Act of 1934, as amended. Forward-looking statements address our expected future business, financial performance, financial condition, as well as the results of operations and often contain words such as "anticipate" "believe," "expect," "may," "plan," "potential," "will," and similar expressions. Such statements are based only upon current expectations of Adaptimmune. Reliance should not be placed on these forward-looking statements because they 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, 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):
| September 30, | December 31, | |||||
| 2024 | 2023 | |||||
| Cash and cash equivalents | $ | 116,741 | $ | 143,991 | ||
| Marketable securities - available-for-sale debt securities | 69,349 | 2,947 | ||||
| Total Liquidity | $ | 186,090 | $ | 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 | Nine months ended | |||||||||||
| September 30, | September 30, | |||||||||||
| 2024 | 2023 | 2024 | 2023 | |||||||||
| Revenue | $ | 40,901 | $ | 7,319 | $ | 174,810 | $ | 60,050 | ||||
| Operating expenses | ||||||||||||
| Research and development | (34,304) | (37,788) | (109,959) | (93,301) | ||||||||
| Selling, general and administrative | (21,277) | (16,164) | (60,092) | (56,634) | ||||||||
| Total operating expenses | (55,581) | (53,952) | (170,051) | (149,935) | ||||||||
| Operating (loss)/profit | (14,680) | (46,633) | 4,759 | (89,885) | ||||||||
| Interest income | 2,096 | 2,149 | 4,817 | 4,368 | ||||||||
| Interest expense | (1,109) | - | (1,635) | - | ||||||||
| Gain on bargain purchase | - | (106) | - | 22,049 | ||||||||
| Other income (expense), net | (3,093) | (324) | (2,657) | (494) | ||||||||
| (Loss)/profit before income tax expense | (16,786) | (44,914) | 5,284 | (63,962) | ||||||||
| Income tax expense | (831) | (687) | (1,883) | (1,992) | ||||||||
| Net (loss)/profit attributable to ordinary shareholders | $ | (17,617) | $ | (45,601) | $ | 3,401 | $ | (65,954) | ||||
| Net (loss)/profit per ordinary share | ||||||||||||
| Basic | $ | (0.01) | $ | (0.03) | $ | 0.00 | $ | (0.06) | ||||
| Diluted | $ | (0.01) | $ | (0.03) | $ | 0.00 | $ | (0.06) | ||||
| Weighted average shares outstanding: | ||||||||||||
| Basic | 1,534,613,977 | 1,357,849,656 | 1,506,565,234 | 1,153,791,567 | ||||||||
| Diluted | 1,534,613,977 | 1,357,849,656 | 1,537,021,778 | 1,153,791,567 |
Condensed Consolidated Balance Sheets
(unaudited, in thousands, except share data)
| September 30, | December 31, | |||||
| 2024 | 2023 | |||||
| Assets | ||||||
| Current assets | ||||||
| Cash and cash equivalents | $ | 116,741 | $ | 143,991 | ||
| Marketable securities - available-for-sale debt securities (amortized cost of $69,293 and $2,940) net of allowance for expected credit losses of $0 and $0 | 69,349 | 2,947 | ||||
| Accounts receivable, net of allowance for expected credit losses of $0 and $0 | 12,500 | 821 | ||||
| Inventory, net | 1,874 | - | ||||
| Other current assets and prepaid expenses | 43,750 | 59,793 | ||||
| Total current assets | 244,214 | 207,552 | ||||
| Restricted cash | 2,681 | 3,026 | ||||
| Other noncurrent assets | 968 | - | ||||
| Operating lease right-of-use assets, net of accumulated amortization of $17,243 and $13,220 | 20,494 | 20,762 | ||||
| Property, plant and equipment, net of accumulated depreciation of $55,697 and $46,020 | 44,796 | 50,946 | ||||
| Intangible assets, net of accumulated amortization of $5,525 and $5,155 | 4,283 | 330 | ||||
| Total assets | $ | 317,436 | $ | 282,616 | ||
| Liabilities and stockholders' equity | ||||||
| Current liabilities | ||||||
| Accounts payable | $ | 9,069 | $ | 8,128 | ||
| Operating lease liabilities, current | 4,175 | 5,384 | ||||
| Accrued expenses and other current liabilities | 31,504 | 30,303 | ||||
| Deferred revenue, current | 18,709 | 28,973 | ||||
| Total current liabilities | 63,457 | 72,788 | ||||
| Operating lease liabilities, non-current | 20,455 | 19,851 | ||||
| Deferred revenue, non-current | 98,731 | 149,060 | ||||
| Borrowings, non-current | 49,865 | - | ||||
| Other liabilities, non-current | 4,939 | 1,404 | ||||
| Total liabilities | 237,447 | 243,103 | ||||
| Stockholders' equity | ||||||
| Common stock - Ordinary shares par value 0.001, 2,039,252,874 authorized and 1,534,889,490 issued and outstanding (2023: 1,702,760,280 authorized and 1,363,008,102 issued and outstanding) | 2,084 | 1,865 | ||||
| Additional paid in capital | 1,102,813 | 1,064,569 | ||||
| Accumulated other comprehensive loss | (5,136) | (3,748) | ||||
| Accumulated deficit | (1,019,772) | (1,023,173) | ||||
| Total stockholders' equity | 79,989 | 39,513 | ||||
| Total liabilities and stockholders' equity | $ | 317,436 | $ | 282,616 |
Condensed Consolidated Cash Flow Statement
(unaudited, in thousands)
| Nine months ended | ||||||
| September 30, | ||||||
| 2024 | 2023 | |||||
| Cash flows from operating activities | ||||||
| Net profit/(loss) | $ | 3,401 | $ | (65,954) | ||
| Adjustments to reconcile net loss to net cash used in operating activities: | ||||||
| Depreciation | 8,156 | 6,647 | ||||
| Amortization | 234 | 322 | ||||
| Gain on bargain purchase | - | (22,049) | ||||
| Share-based compensation expense | 9,215 | 8,692 | ||||
| Unrealized foreign exchange losses | 3,164 | 709 | ||||
| Accretion on available-for-sale debt securities | (544) | (1,595) | ||||
| Other | (104) | 253 | ||||
| Changes in operating assets and liabilities: | ||||||
| Decrease/(increase) in receivables and other operating assets | 5,426 | (709) | ||||
| Increase in inventories | (1,869) | - | ||||
| Increase/(decrease) in payables and other current liabilities | 1,173 | (7,792) | ||||
| Increase in noncurrent assets | (926) | - | ||||
| Increase in borrowings and other non-current liabilities | 1,480 | - | ||||
| Decrease in deferred revenue | (67,808) | (44,728) | ||||
| Net cash used in operating activities | (39,002) | (126,204) | ||||
| Cash flows from investing activities | ||||||
| Acquisition of property, plant and equipment | (667) | (3,854) | ||||
| Acquisition of intangible assets | (880) | (199) | ||||
| Cash from acquisition of TCR2 Therapeutics Inc. | - | 45,264 | ||||
| Maturity or redemption of marketable securities | - | 139,243 | ||||
| Investment in marketable securities | (65,701) | (73,026) | ||||
| Other | 129 | 913 | ||||
| Net cash (used in)/provided by investing activities | (67,119) | 108,341 | ||||
| Cash flows from financing activities | ||||||
| Proceeds from issuance of borrowings, net of discount | 49,500 | - | ||||
| Proceeds from issuance of common stock from offerings, net of commissions and issuance costs | 29,171 | 623 | ||||
| Proceeds from exercise of stock options | 77 | 183 | ||||
| Net cash provided by financing activities | 78,748 | 806 | ||||
| Effect of currency exchange rate changes on cash, cash equivalents and restricted cash | (222) | 527 | ||||
| Net decrease in cash, cash equivalents and restricted cash | (27,595) | (16,530) | ||||
| Cash, cash equivalents and restricted cash at start of period | 147,017 | 109,602 | ||||
| Cash, cash equivalents and restricted cash at end of period | $ | 119,422 | $ | 93,072 |
Juli P. Miller, Ph.D. - VP, Corporate Affairs and Investor Relations
Dana Lynch, Senior Director of Corporate Communications