Full Press Release Details
Adaptimmune Reports Third-Quarter Financial Results and Business Update
- Adaptimmune will focus on programs in MAGE-A4 and PRAME, two of the most validated
T-Cell targets in solid tumors -
- Adaptimmune will initiate a rolling BLA submission for afami-cel for the treatment of synovial sarcoma in Q4 2022 with target for completion in mid-year 2023 -
-The Company will focus on advancing the SURPASS family of trials in ovarian, urothelial, and head & neck cancers, for which the ORR is now 52% -
- Adaptimmune plans to advance its wholly owned late-stage preclinical optimized PRAME TCR, to be IND-ready in 2023 -
- To extend its cash runway into early 2025, the Company will de-prioritize non-core programs and undertake a significant restructuring with a reduction in headcount of approximately 25% to 30% -
- Conference call to be held today, November 8, 2022, at 8:00 a.m. EST (1:00 p.m. GMT) -
PHILADELPHIA, PA. and OXFORD, UK, November 8, 2022 - Adaptimmune Therapeutics plc (Nasdaq: ADAP), a leader in cell therapy to treat cancer, today reported financial results and business updates for the third quarter ending September 30, 2022. For the quarter ending September 30, 2022, Revenue was $7.0 million, Total Operating Expenses (Research and Development and General and Administrative) were $50 million, and Net Loss was $41.4 million. The Company provided a clinical update earlier today which is available here: https://bit.ly/3TYsqcZ.
"We are seeing the positive impact that our therapies can have on people with cancer with afami-cel and unprecedented data with our next-gen T-cell therapy in the SURPASS trial," said Adrian Rawcliffe, Adaptimmune's Chief Executive Officer. "We now have full control of our T-cell program directed to PRAME, an equally important T-cell target in solid tumors. It is evident that we need to focus on developing these two programs which have immense therapeutic potential. We have taken decisive action to deprioritize non-core programs and made the difficult decision to restructure to extend our cash runway into early 2025."
Afami-cel update: Adaptimmune's first-generation cell therapy targeting MAGE-A4
BLA strategy for Adaptimmune's first potential commercial product
Positive and confirmatory data from Cohort 1 of the registrational SPEARHEAD-1 trial to be presented at the Connective Tissue Oncology Society (CTOS) annual meeting on November 18th
Status of the ongoing SPEARHEAD-1 pivotal trial and other afami-cel news
Financial Results for the three and nine months ended September 30, 2022
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 nine months ended September 30, 2022, to be filed with the Securities and Exchange Commission following this earnings release. The Company is deprioritizing non-core programs and is also undertaking a restructuring of the Company including a headcount reduction of approximately 25% to 30% with the aim of extending its cash runway into early 2025.
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. GMT) today, November 8, 2022. A live webcast of the conference call and replay can be accessed at https://www.gowebcasting.com/12251. Call in information is as follows: (800)- 319-4610 (US or Canada) or +1 (416)- 915-3239 (International and additional options available HERE).
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
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):
| September 30, | December 31, | |||||
| 2022 | 2021 | |||||
| Cash and cash equivalents | $ | 79,001 | $ | 149,948 | ||
| Marketable securities - available-for-sale debt securities | 120,669 | 219,632 | ||||
| Total Liquidity | $ | 199,670 | $ | 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 | Nine months ended | ||||||||||||
| September 30, | September 30, | ||||||||||||
| 2022 | 2021 | 2022 | 2021 | ||||||||||
| Revenue | $ | 7,007 | $ | 1,203 | $ | 16,120 | $ | 4,732 | |||||
| Operating expenses | |||||||||||||
| Research and development | (33,182) | (28,211) | (104,674) | (81,585) | |||||||||
| General and administrative | (16,815) | (15,173) | (48,169) | (42,529) | |||||||||
| Total operating expenses | (49,997) | (43,384) | (152,843) | (124,114) | |||||||||
| Operating loss | (42,990) | (42,181) | (136,723) | (119,382) | |||||||||
| Interest income | 324 | 225 | 1,019 | 916 | |||||||||
| Other (expense) income, net | 1,644 | (237) | 1,001 | (184) | |||||||||
| Loss before income tax expense | (41,022) | (42,193) | (134,703) | (118,650) | |||||||||
| Income tax expense | (399) | (208) | (1,503) | (582) | |||||||||
| Net loss attributable to ordinary shareholders | $ | (41,421) | $ | (42,401) | $ | (136,206) | $ | (119,232) | |||||
| Net loss per ordinary share | |||||||||||||
| Basic and diluted | $ | (0.04) | $ | (0.05) | $ | (0.14) | $ | (0.13) | |||||
| Weighted average shares outstanding: | |||||||||||||
| Basic and diluted | 980,791,114 | 936,600,648 | 961,354,122 | 933,992,708 |
Condensed Consolidated Balance Sheets
(unaudited, in thousands, except share data)
| September 30, | December 31, | |||||
| 2022 | 2021 | |||||
| Assets | ||||||
| Current assets | ||||||
| Cash and cash equivalents | $ | 79,001 | $ | 149,948 | ||
| Marketable securities - available-for-sale debt securities | 120,669 | 219,632 | ||||
| Accounts receivable, net of allowance for doubtful accounts of $0 and $0 | 1,774 | 752 | ||||
| Other current assets and prepaid expenses | 62,695 | 45,126 | ||||
| Total current assets | 264,139 | 415,458 | ||||
| Restricted cash | 1,712 | 1,718 | ||||
| Operating lease right-of-use assets, net of accumulated amortization | 17,607 | 20,875 | ||||
| Property, plant and equipment, net of accumulated depreciation of $35,229 and $36,253 | 48,176 | 30,494 | ||||
| Intangible assets, net of accumulated amortization of $4,354 and $4,051 | 568 | 1,000 | ||||
| Total assets | $ | 332,202 | $ | 469,545 | ||
| Liabilities and stockholders' equity | ||||||
| Current liabilities | ||||||
| Accounts payable | $ | 6,905 | $ | 8,113 | ||
| Operating lease liabilities, current | 2,474 | 2,320 | ||||
| Accrued expenses and other current liabilities | 36,079 | 29,909 | ||||
| Deferred revenue, current | 20,622 | 22,199 | ||||
| Total current liabilities | 66,080 | 62,541 | ||||
| Operating lease liabilities, non-current | 19,926 | 23,148 | ||||
| Deferred revenue, non-current | 132,233 | 177,223 | ||||
| Other liabilities, non-current | 626 | 673 | ||||
| Total liabilities | 218,865 | 263,585 | ||||
| Stockholders' equity | ||||||
| Common stock - Ordinary shares par value 0.001, 1,282,773,750 authorized and 982,719,936 issued and outstanding (2021: 1,240,853,520 authorized and 937,547,934 issued and outstanding) | 1,394 | 1,337 | ||||
| Additional paid in capital | 985,312 | 959,611 | ||||
| Accumulated other comprehensive income (loss) | 6,683 | (11,142) | ||||
| Accumulated deficit | (880,052) | (743,846) | ||||
| Total stockholders' equity | 113,337 | 205,960 | ||||
| Total liabilities and stockholders' equity | $ | 332,202 | $ | 469,545 |
Condensed Consolidated Cash Flow Statement
(unaudited, in thousands)
| Nine months ended | ||||||
| September 30, | ||||||
| 2022 | 2021 | |||||
| Cash flows from operating activities | ||||||
| Net loss | $ | (136,206) | $ | (119,232) | ||
| Adjustments to reconcile net loss to net cash used in operating activities: | ||||||
| Depreciation | 4,009 | 4,333 | ||||
| Amortization | 629 | - | ||||
| Share-based compensation expense | 14,294 | 15,802 | ||||
| Unrealized foreign exchange gains | (2,501) | (213) | ||||
| Amortization on available-for-sale debt securities | 2,165 | 4,094 | ||||
| Other | 765 | 2,239 | ||||
| Changes in operating assets and liabilities: | ||||||
| Increase in receivables and other operating assets | (29,778) | (31,809) | ||||
| Increase/ (decrease) in payables and other current liabilities | 15,200 | (109) | ||||
| (Decrease)/ increase in deferred revenue | (12,388) | 1,696 | ||||
| Net cash used in operating activities | (143,811) | (123,199) | ||||
| Cash flows from investing activities | ||||||
| Acquisition of property, plant and equipment | (26,081) | (4,558) | ||||
| Acquisition of intangible assets | (231) | (181) | ||||
| Maturity or redemption of marketable securities | 136,694 | 190,393 | ||||
| Investment in marketable securities | (42,197) | (81,363) | ||||
| Net cash provided by investing activities | 68,185 | 104,291 | ||||
| Cash flows from financing activities | ||||||
| Proceeds from issuance of common stock from offerings, net of commissions and issuance costs | 11,422 | 2,529 | ||||
| Proceeds from exercise of stock options | 42 | 707 | ||||
| Net cash provided by financing activities | 11,464 | 3,236 | ||||
| Effect of currency exchange rate changes on cash, cash equivalents and restricted cash | (6,791) | (1,177) | ||||
| Net decrease in cash, cash equivalents and restricted cash | (70,953) | (16,849) | ||||
| Cash, cash equivalents and restricted cash at start of period | 151,666 | 61,484 | ||||
| Cash, cash equivalents and restricted cash at end of period | $ | 80,713 | $ | 44,635 |
Juli P. Miller, Ph.D. - VP, Corporate Affairs and Investor Relations
Dana Lynch, Senior Director of Corporate Communications