Full Press Release Details
Adaptimmune Reports Fourth Quarter / Full Year 2020 Financial Results and Business Update
- Outlined strategy to build integrated cell therapy company and the Company's
"2-2-5-2" five-year core value drivers -
- Reported compelling durable responses in patients with synovial sarcoma, and initial responses in lung, head and neck, liver, esophagogastric junction, and melanoma cancers confirming potential of
SPEAR T-cells for solid tumors -
- Completed enrollment of SPEARHEAD-1 clinical trial, to support planned BLA filing and commercialization in 2022 for ADP-A2M4 for people with synovial sarcoma -
- Initiating Phase 2 trial (SURPASS-2) with ADP-A2M4CD8 in esophageal and esophagogastric junction cancers in 1H 2021 -
- Demonstrated killing of cancer cells with T-cells derived from the Company's allogeneic platform. MAGE-A4 and mesothelin to be first allogeneic programs into the clinic -
- Financial guidance confirmed: funded into early 2023 -
PHILADELPHIA, PA. and OXFORD, UK, February 25, 2021 - Adaptimmune Therapeutics plc (Nasdaq:ADAP), a leader in cell therapy to treat cancer, today reported financial results for the fourth quarter and year ended December 31, 2020, and provided a business update.
"We are building the cell therapy company of the future for people with cancer. With our 2-2-5-2' by 2025 strategic plan, we will deliver value with marketed SPEAR T-cell products starting with ADP-A2M4 for people with synovial sarcoma," said Adrian Rawcliffe, Adaptimmune's Chief Executive Officer. "We completed enrollment in our SPEARHEAD-1 trial in approximately 12 months to support our first BLA, which is strong evidence of our ability to execute rapidly. We are focusing the SURPASS trial, using our next-generation ADP-A2M4CD8 product, on lung, gastroesophageal, head and neck, and bladder cancers to identify new indications to take forward to late-stage development."
Planned 2021 data updates1
1 All data updates subject to congress acceptance
2 The main portion of the ADP-A2M4 Phase 1 trial is closed for enrollment
"2-2-5-2" by 2025 strategic plan
At an Investor Day held in November 2020, the Company outlined its "2-2-5-2" by 2025 strategic plan encompassing:
"2" - Two marketed products targeting MAGE-A4
Estimated potential addressable population in tumor types with significant MAGE-A4 expression, factored for HLA-A23, is ~39,000 patients per year in the US and EU
Durable responses in synovial sarcoma - on track to file a Biologics License Application (BLA) for ADP-A2M4 in 2022
SURPASS-2 in esophageal and esophagogastric junction (EGJ) cancers in 1H 2021
3 Mortality figures based on American Cancer Society 2020 (US) and Global Can (EU) - synovial sarcoma data based on internal market research; MAGE-A4 expression ranges based on Adaptimmune samples and expression cut-off criteria of 30% tumor cells at 2+ intensity; HLA-A2 expression of 41% based on Adaptimmune samples (1,043 patient samples); serum AFP expression ranges based on internal samples (62 patients) and expression cut off >100ng/mL
4 Pollack S, et al. Cancer Medicine. 2020; 9:4593-4602; Seto T, et al Med. Sci. 2019, 7, 48; van der Graaf WT, et al. 2012, Lancet, 379(9829), 1879-1886
"2" - Two additional BLAs for SPEAR T-cell products
"5" - Five new autologous products in the clinic
"2" - Two allogeneic products in the clinic
Corporate updates from 2020
Financial Results for the fourth quarter and year ended December 31, 2020
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 Annual Report on Form 10-K for the year ended December 31, 2020, 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. EST (1:00 p.m. GMT) today, February 25, 2021. The live webcast of the conference call will be available via the Events page of Adaptimmune's corporate website at www.adaptimmune.com. 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 (2099860).
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.
5 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 SEC on November 5, 2020, 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 consolidated balance sheet. The U.S. GAAP financial measure most directly comparable to Total Liquidity is cash and cash equivalents as reported in the consolidated financial statements, which reconciles to Total Liquidity as follows (in millions):
| December 31, | December 31, | |||||
| 2020 | 2019 | |||||
| Cash and cash equivalents | $ | 56,882 | $ | 50,412 | ||
| Marketable securities - available-for-sale debt securities | 311,335 | 39,130 | ||||
| Total Liquidity | $ | 368,217 | $ | 89,542 |
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.
Consolidated Statement of Operations
(unaudited, in thousands, except per share data)
| Three months ended | Year ended | ||||||||||||||
| December 31, | December 31, | ||||||||||||||
| 2020 | 2019 | 2020 | 2019 | ||||||||||||
| Revenue | 1,502 | 728 | 3,958 | 1,122 | |||||||||||
| Operating expenses | |||||||||||||||
| Research and development (including losses accrued on firm purchase commitments of $0, $0, $0 and $5,000) | (25,777) | (20,354) | (91,568) | (97,501) | |||||||||||
| General and administrative | (13,238) | (10,729) | (45,795) | (43,391) | |||||||||||
| Total operating expenses | (39,015) | (31,083) | (137,363) | (140,892) | |||||||||||
| Operating loss | (37,513) | (30,355) | (133,405) | (139,770) | |||||||||||
| Interest income | 538 | 448 | 2,313 | 2,772 | |||||||||||
| Other income (expense), net | 414 | 631 | 1,162 | 75 | |||||||||||
| Loss before income taxes | (36,561) | (29,276) | (129,930) | (136,923) | |||||||||||
| Income taxes | (52) | (88) | (162) | (242) | |||||||||||
| Net loss attributable to ordinary shareholders | $ | (36,613) | $ | (29,364) | $ | (130,092) | $ | (137,165) | |||||||
| Net loss per ordinary share | |||||||||||||||
| Basic and diluted | $ | (0.04) | $ | (0.05) | $ | (0.15) | $ | (0.22) | |||||||
| Weighted average shares outstanding: | |||||||||||||||
| Basic and diluted | 928,676,161 | 630,994,079 | 854,783,763 | 629,805,218 |
Consolidated Balance Sheets
(unaudited, in thousands, except share data)
| December 31, | December 31, | |||||
| 2020 | 2019 | |||||
| Assets | ||||||
| Current assets | ||||||
| Cash and cash equivalents | $ | 56,882 | $ | 50,412 | ||
| Marketable securities - available-for-sale debt securities | 311,335 | 39,130 | ||||
| Accounts receivable, net of allowance for doubtful accounts of $0 and $0 | 139 | - | ||||
| Other current assets and prepaid expenses (including current portion of clinical materials) | 29,796 | 30,947 | ||||
| Total current assets | 398,152 | 120,489 | ||||
| Restricted cash | 4,602 | 4,496 | ||||
| Clinical materials | - | 2,503 | ||||
| Operating lease right-of-use assets, net of accumulated amortization | 18,880 | 20,789 | ||||
| Property, plant and equipment, net of accumulated depreciation | 27,778 | 31,068 | ||||
| Intangibles, net of accumulated amortization | 1,730 | 2,198 | ||||
| Total assets | $ | 451,142 | $ | 181,543 | ||
| Liabilities and stockholders' equity | ||||||
| Current liabilities | ||||||
| Accounts payable | $ | 6,389 | $ | 6,357 | ||
| Operating lease liabilities, current | 2,773 | 2,493 | ||||
| Accrued expenses and other accrued liabilities | 27,079 | 23,363 | ||||
| Deferred revenue, current | 2,832 | 2,128 | ||||
| Total current liabilities | 39,073 | 34,341 | ||||
| Operating lease liabilities, non-current | 20,938 | 22,966 | ||||
| Deferred revenue, non-current | 49,260 | - | ||||
| Other liabilities, non-current | 644 | 598 | ||||
| Total liabilities | 109,915 | 57,905 | ||||
| Stockholders' equity | ||||||
| Common stock - Ordinary shares par value 0.001, 1,038,249,630 authorized and 928,754,958 issued and outstanding (2019: 785,857,300 authorized and 631,003,568 issued and outstanding) | 1,325 | 943 | ||||
| Additional paid in capital | 935,706 | 585,623 | ||||
| Accumulated other comprehensive loss | (10,048) | (7,264) | ||||
| Accumulated deficit | (585,756) | (455,664) | ||||
| Total stockholders' equity | 341,227 | 123,638 | ||||
| Total liabilities and stockholders' equity | $ | 451,142 | $ | 181,543 |
Consolidated Cash Flow Statement
(unaudited, in thousands)
| Year ended | Year ended | |||||
| December 31, | December 31, | |||||
| 2020 | 2019 | |||||
| Cash flows from operating activities | ||||||
| Net loss | $ | (130,092) | $ | (137,165) | ||
| Adjustments to reconcile net loss to net cash used in operating activities: | ||||||
| Depreciation | 6,627 | 7,172 | ||||
| Amortization | 967 | 838 | ||||
| Share-based compensation expense | 10,414 | 11,053 | ||||
| Unrealized foreign exchange (gains) losses | (1,333) | 1,076 | ||||
| Amortization (accretion) on available-for-sale debt securities | 3,836 | (185) | ||||
| Other | (55) | (13) | ||||
| Changes in operating assets and liabilities: | ||||||
| Decrease (increase) in receivables and other operating assets | 1,747 | (1,436) | ||||
| Decrease (increase) in non-current operating assets | 2,458 | (1,450) | ||||
| Increase (decrease) in payables and other liabilities | 3,867 | 5,508 | ||||
| Increase (decrease) in deferred revenue | 47,973 | 2,095 | ||||
| Net cash used in operating activities | (53,591) | (112,507) | ||||
| Cash flows from investing activities | ||||||
| Acquisition of property, plant and equipment | (2,341) | (1,592) | ||||
| Acquisition of intangibles | (565) | (1,482) | ||||
| Maturity or redemption of marketable securities | 105,022 | 125,303 | ||||
| Investment in marketable securities | (381,040) | (27,284) | ||||
| Net cash (used in) provided by investing activities | (278,924) | 94,945 | ||||
| Cash flows from financing activities | ||||||
| Proceeds from issuance of shares in the January offering | 78,616 | - | ||||
| Proceeds from issuance of shares upon exercise of the overallotment for the January Offering | 11,938 | - | ||||
| Proceeds from issuance of shares in the June Offering | 209,986 | - | ||||
| Proceeds from issuance of shares upon exercise of the overallotment for the June Offering | 33,848 | - | ||||
| Proceeds from exercise of stock options | 5,663 | 366 | ||||
| Net cash provided by financing activities | 340,051 | 366 | ||||
| Effect of currency exchange rate changes on cash, cash equivalents and restricted cash | (960) | (372) | ||||
| Net increase (decrease) in cash, cash equivalents and restricted cash | 6,576 | (17,568) | ||||
| Cash, cash equivalents and restricted cash at start of period | 54,908 | 72,476 | ||||
| Cash, cash equivalents and restricted cash at end of period | $ | 61,484 | $ | 54,908 |
Adaptimmune Contacts:
S bastien Desprez - VP, Communications and Investor Relations
Juli P. Miller, Ph.D. - Senior Director, Investor Relations