GlobeNewswire Inc | Aug 9, 2021 04:00PM EDT

August 09, 2021

- SPEARHEAD-1 data presented at ASCO with overall response rate of 39.3% in synovial sarcoma and MRCLS; on track to file BLA for afami-cel next year -

- SURPASS trial data from 23 evaluable patients to be presented at ESMO -

- ADP-A2AFP Phase 1 trial data from 11 evaluable patients in Group 3/Expansion to be presented at ILCA -

- Financial guidance confirmed: funded into early 2023 -

- Conference call to be held today at 4:30 p.m. EDT (9:30 p.m. BST) -

PHILADELPHIA and OXFORDSHIRE, United Kingdom, Aug. 09, 2021 (GLOBE NEWSWIRE) -- Adaptimmune Therapeutics plc(Nasdaq: ADAP), a leader in cell therapy to treat cancer, today reported financial results for the second quarter ended June 30, 2021 and provided a business update.

With the data presented at ASCO for afami-cel and our planned BLA filing next year, I am pleased with progress on our 2-2-5-2 strategy, said Adrian Rawcliffe, Adaptimmunes Chief Executive Officer. We will present data updates from our Phase 1 trials, SURPASS and ADP-A2AFP, at upcoming conferences and I am confident that Adaptimmune is well-placed to maintain its leadership position in cell therapies for cancer.

Upcoming confirmed data updatesADP-A2AFP Phase 1 Trial at ILCA

-- On Sunday, September 5, 2021, Dr. Bruno Sangro of Clinica Universidad de Navarra will present data from Cohort 3 and the expansion phase of the Phase 1 trial of ADP-A2AFP in liver cancer during an oral presentation scheduled for 12:25 p.m. CET at the International Liver Cancer Associations (ILCA) Annual Conference As of the April 5th data cut-off used for ILCA, 13 patients had received ADP-A2AFP in Cohort 3 and expansion, 11 patients were evaluable with at least one post-baseline scan

SURPASS Phase 1 Trial at ESMO

-- The Company will present an update from its Phase 1 SURPASS trial in an e-poster at the European Society for Medical Oncology (ESMO) congress that will be available online September 16thAs of the August 2nd data cut-off, 25 patients had received ADP-A2M4CD8, 23 patients had at least one post-baseline scanThe trial continues to recruit in lung, gastroesophageal, head and neck, and bladder cancers focus indications, for which there have been early signs of efficacy, including responses, with SPEAR T-cells targeting MAGE-A4Based on early data from patients with ovarian cancer treated in the trial, the Company is planning to add this as a focus indication to the SURPASS trial

SPEARHEAD-1 and afami-cel BLA

-- As presented at ASCO 2021, the Company reported an overall response rate for patients with at least one scan (evaluated by RECIST 1.1 per investigator assessment) of 39.3% (13/33), 41.4% (12/29) for synovial sarcoma, including two complete responses, and 25.0% (1/4) for MRCLS from its Phase 2 SPEARHEAD-1 trial -- Of the 29 patients with synovial sarcoma, the disease control rate (defined as either response or stable disease) was 86.2% (25/29 patients) with 2 complete responses and 10 partial responses -- This data set is intended to support planned BLA filing next year -- Next data update planned at CTOS 2021 -- The European Medicines Agency and the FDA have agreed to Adaptimmunes pediatric investigational plans -- Working with key industry leaders to prepare for a successful commercial launch Adaptimmune has partnered with Agilent for the development, manufacturing, and supply of a companion diagnostic for the MAGE-A4 biomarkerThe Company is also working with Miltenyi Biotec for the process validation, manufacture, and supply of the lentiviral vector for use in the product for commercial launch

Further indications for next-gen SPEAR T-cell therapiesSURPASS-2

-- Planning to initiate a Phase 2 clinical trial with ADP-A2M4CD8, SURPASS-2, in esophageal and esophagogastric junction cancers in the third quarter of 2021

Other early-stage programs

-- The Company ceased enrollment in the Radiation Sub-Study of the afami-cel Phase 1 trial at the end of July. Five patients were treated in this sub-study and the Company plans to provide a data update at an upcoming congress

Corporate

-- The Company received a development milestone payment of $4.2 million in the three months ended June 30, 2021

Financial Results for the three and six months ended June 30, 2021

-- Cash / liquidity position: As of June 30, 2021, Adaptimmune had cash and cash equivalents of $50.5 million and Total Liquidity1 of $285.4 million. -- Revenue: Revenue for the three and six months ended June 30, 2021 was $3.1 million and $3.5 million, respectively, compared to $0.5 million and $1.3 million for the same periods in 2020. Revenue has increased primarily due to an increase in development activities under the Astellas Collaboration Agreement. -- Research and development (R&D) expenses: R&D expenses for the three and six months ended June 30, 2021 were $28.9 million and $53.4 million, respectively, compared to $20.5 million and $41.7 million for the same periods in 2020. R&D expenses increased due to an increase in the number of employees engaged in research and development, and increases in costs related to the development of a companion diagnostic assay and our Phase 2 clinical trial associated with ADP-A2M4CD8. These increases were partially offset by an increase in reimbursements receivable for research and development tax and expenditure credits. -- General and administrative (G&A) expenses: G&A expenses for the three and six months ended June 30, 2021 were $13.5 million and $27.4 million, respectively, compared to $10.3 million and $19.6 million for the same periods in 2020 due to increases in employee-related costs, share-based compensation expense, and professional fees. -- Net loss: Net loss attributable to holders of the Companys ordinary shares for the three and six months ended June 30, 2021 was $39.1 million and $76.8 million respectively ($(0.04) and $(0.08) per ordinary share), compared to $29.9million and $58.0 million ($(0.04) and $(0.07) per ordinary share) for the same periods in 2020.

Financial Guidance

The Company believes that its existing cash, cash equivalents and marketable securities will fund the Companys current operations into early 2023, as further detailed in the Companys Quarterly Report on Form 10-Q for the three and six months ended June 30, 2021, to be filed with the Securities and Exchange Commission following this earnings release.

Conference Call InformationThe Company will host a live teleconference and webcast to provide additional details at4:30 p.m. EDT(9:30 p.m. BST) today. A live webcast of the conference call and replay can be accessed at https://bit.ly/3zFas59. 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 (7867634).

About AdaptimmuneAdaptimmuneis a clinical-stage biopharmaceutical company focused on the development of novel cancer immunotherapy products for people with cancer. The Companys 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.

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.

Forward-Looking StatementsThis 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 Securities and Exchange Commission (SEC) on May 6, 2021 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 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):

June30, December31, 2021 2020Cash and cash equivalents $ 50,453 $ 56,882Marketable securities -available-for-sale debt 234,917 311,335securitiesTotal Liquidity $ 285,370 $ 368,217

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.

Condensed Consolidated Statement of Operations(unaudited, in thousands, except per share data)

Three months ended Six months ended June30, June30, 2021 2020 2021 2020 Revenue $ 3,095 $ 502 $ 3,529 $ 1,263 Operating expensesResearch and (28,868 ) (20,460 ) (53,374 ) (41,724 ) developmentGeneral and (13,539 ) (10,295 ) (27,356 ) (19,556 ) administrativeTotaloperating (42,407 ) (30,755 ) (80,730 ) (61,280 ) expensesOperating loss (39,312 ) (30,253 ) (77,201 ) (60,017 ) Interest 266 1,147 691 1,877 incomeOther income 54 (749 ) 53 188 (expense), netLoss before (38,992 ) (29,855 ) (76,457 ) (57,952 ) income taxesIncome taxes (76 ) (25 ) (374 ) (95 ) Net lossattributable $ (39,068 ) $ (29,880 ) $ (76,831 ) $ (58,047 ) to ordinaryshareholders Net loss per ordinary shareBasic and $ (0.04 ) $ (0.04 ) $ (0.08 ) $ (0.07 ) diluted Weightedaverage shares outstanding:Basic and 934,228,095 822,725,556 932,667,125 781,235,457 diluted

Condensed Consolidated Balance Sheets(unaudited, in thousands, except share data)

June30, December31, 2021 2020 Assets Current assets Cash and cash equivalents $ 50,453 $ 56,882 Marketable securities - available-for-sale 234,917 311,335 debt securitiesAccounts receivable, net of allowance for 2,158 139 doubtful accounts of $0 and $0Other current assets and prepaid expenses 49,816 29,796 Total current assets 337,344 398,152 Restricted cash 4,632 4,602 Operating lease right-of-use assets, net of 17,772 18,880 accumulated amortizationProperty, plantand equipment, net ofaccumulated depreciation of $34,360 (2020: 28,663 27,778 $31,097)Intangibles, net of accumulated 1,382 1,730 amortizationTotal assets $ 389,793 $ 451,142 Liabilities and stockholders? equity Current liabilities Accounts payable $ 6,977 $ 6,389 Operating lease liabilities, current 2,922 2,773 Accrued expenses and other accrued 26,606 27,079 liabilitiesDeferred revenue, current 4,911 2,832 Total current liabilities 41,416 39,073 Operating lease liabilities, non-current 19,723 20,938 Deferred revenue, non-current 50,048 49,260 Other liabilities, non-current 667 644 Total liabilities 111,854 109,915 Stockholders? equity Common stock - Ordinary shares par value0.001, 1,240,853,520 authorized and936,237,126 issued and outstanding (2020: 1,336 1,325 1,038,249,630 authorized and928,754,958issuedand outstanding)Additional paid in capital 949,575 935,706 Accumulated other comprehensive loss (10,385 ) (10,048 )Accumulated deficit (662,587 ) (585,756 )Total stockholders' equity 277,939 341,227 Total liabilities and stockholders? equity $ 389,793 $ 451,142

Condensed Consolidated Cash Flow Statement(unaudited, in thousands)

Six months ended June30, 2021 2020 Cash flows from operating activities Net loss $ (76,831 ) $ (58,047 )Adjustments to reconcile net loss to net cash used in operating activities:Depreciation 2,879 3,583 Share-based compensation expense 10,783 4,072 Unrealized foreign exchange gains (267 ) (2,004 )Amortization on available-for-sale debt 2,884 702 securitiesOther 1,401 480 Changes in operating assets and liabilities: Increase in receivables and other operating (21,457 ) (10,104 )assetsDecrease in non-current operating assets ? 615 Increase in payables and other current 663 3,571 liabilitiesIncrease in deferred revenue 1,946 49,074 Net cash used in operating activities (77,999 ) (8,058 ) Cash flows from investing activities Acquisition of property, plantand equipment (2,924 ) (460 )Acquisition of intangibles (143 ) (407 )Maturity or redemption of marketable 154,465 39,931 securitiesInvestment in marketable securities (81,958 ) (298,016 )Net cash provided by (used in) investing 69,440 (258,952 )activities Cash flows from financing activities Proceeds from issuance of common stock fromofferings, net of commissions and issuance 2,519 334,388 costsProceeds from exercise of stock options 578 5,075 Net cash provided by financing activities 3,097 339,463 Effect of currency exchange rate changes on (937 ) (678 )cash, cash equivalents and restricted cashNet (decrease) increase in cash, cash (6,399 ) 71,775 equivalents and restricted cashCash, cash equivalents and restricted cash 61,484 54,908 at start of periodCash, cash equivalents and restricted cash $ 55,085 $ 126,683 at end of period

Adaptimmune Contacts:

Media Relations:

Sbastien Desprez VP, Corporate Affairs and CommunicationsT: +44 1235 430 583M: +44 7718 453 176Sebastien.Desprez@adaptimmune.com

Investor Relations:

Juli P. Miller, Ph.D. VP, Investor RelationsT: +1 215 825 9310M: +1 215 460 8920Juli.Miller@adaptimmune.com