0001104659-19-060267.txt : 20191106 0001104659-19-060267.hdr.sgml : 20191106 20191106073555 ACCESSION NUMBER: 0001104659-19-060267 CONFORMED SUBMISSION TYPE: 8-K PUBLIC DOCUMENT COUNT: 14 CONFORMED PERIOD OF REPORT: 20191106 ITEM INFORMATION: Results of Operations and Financial Condition ITEM INFORMATION: Financial Statements and Exhibits FILED AS OF DATE: 20191106 DATE AS OF CHANGE: 20191106 FILER: COMPANY DATA: COMPANY CONFORMED NAME: Adaptimmune Therapeutics PLC CENTRAL INDEX KEY: 0001621227 STANDARD INDUSTRIAL CLASSIFICATION: BIOLOGICAL PRODUCTS (NO DIAGNOSTIC SUBSTANCES) [2836] IRS NUMBER: 000000000 STATE OF INCORPORATION: X0 FISCAL YEAR END: 1231 FILING VALUES: FORM TYPE: 8-K SEC ACT: 1934 Act SEC FILE NUMBER: 001-37368 FILM NUMBER: 191195090 BUSINESS ADDRESS: STREET 1: 60 JUBILEE AVENUE STREET 2: MILTON PARK CITY: ABINGDON, OXFORDSHIRE STATE: X0 ZIP: OX14 4RX BUSINESS PHONE: 44 1235 430000 MAIL ADDRESS: STREET 1: 60 JUBILEE AVENUE STREET 2: MILTON PARK CITY: ABINGDON, OXFORDSHIRE STATE: X0 ZIP: OX14 4RX FORMER COMPANY: FORMER CONFORMED NAME: Adaptimmune Ltd DATE OF NAME CHANGE: 20141001 8-K 1 tm1921910-1_8k.htm FORM 8-K
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UNITED STATES
SECURITIES AND EXCHANGE COMMISSION

Washington, D.C. 20549

 

FORM 8-K

 

Current Report

Pursuant to Section 13 or 15(d) of

the Securities Exchange Act of 1934

 

Date of Report (Date of earliest event reported): November 6, 2019

 

ADAPTIMMUNE THERAPEUTICS PLC

(Exact name of registrant as specified in its charter)

 

England and Wales   1-37368   Not Applicable
(State or other jurisdiction of
incorporation)		   (Commission File Number)   (IRS Employer Identification No.)

 

 

60 Jubilee Avenue, Milton Park

Abingdon, Oxfordshire OX14 4RX

United Kingdom

(Address of principal executive offices, including zip code)

 

(44) 1235 430000

(Registrant’s telephone number, including area code)

  

Check the appropriate box below if the Form 8-K filing is intended to simultaneously satisfy the filing obligation of the registrant under any of the following provisions: 

 

¨Written communications pursuant to Rule 425 under the Securities Act (17 CFR 230.425)

 

¨Soliciting material pursuant to Rule 14a-12 under the Exchange Act (17 CFR 240.14a-12)

 

¨Pre-commencement communications pursuant to Rule 14d-2(b) under the Exchange Act (17 CFR 240.14d-2(b))

 

¨Pre-commencement communications pursuant to Rule 13e-4(c) under the Exchange Act (17 CFR 240.13e-4(c))

 

Securities registered pursuant to Section 12(b) of the Act:

 

Title of each class   Trading Symbol   Name of each exchange on which registered
American Depositary Shares, each representing 6 Ordinary Shares, par value £0.001 per share   ADAP   The Nasdaq Global Select Market

 

 

Indicate by check mark whether the registrant is an emerging growth company as defined in Rule 405 of the Securities Act of 1933 (§230.405 of this chapter) or Rule 12b-2 of the Securities Exchange Act of 1934 (§240.12b-2 of this chapter).

 

Emerging growth company ¨

 

If an emerging growth company, indicate by check mark if the registrant has elected not to use the extended transition period for complying with any new or revised financial accounting standards provided pursuant to Section 13(a) of the Exchange Act. ¨

 

 

 

 

 

Item 2.02 Results of Operations and Financial Conditions

 

On November 6, 2019, Adaptimmune Therapeutics plc (the “Company”) issued a press release announcing its financial results for the third quarter ended September 30, 2019. The text of the press release is attached as Exhibit 99.1 and is incorporated by reference herein.

 

The information in Item 2.02 of this Form 8-K, including the attached Exhibit 99.1, shall not be deemed "filed" for purposes of Section 18 of the Securities Exchange Act of 1934, as amended, (the "Exchange Act"), or incorporated by reference in any filing made by the Company under the Securities Act of 1933, as amended, or the Exchange Act, except as expressly set forth by the Company by specific reference in such a filing.

 

Item 9.01 Financial Statements and Exhibits.

 

(d) Exhibits.

 

Exhibit No.   Description of Exhibit
     
99.1   Press release dated November 6, 2019
     
104   The cover page from this Current Report on Form 8-K, formatted in Inline XBRL.

 

 

 

 

SIGNATURES

 

Pursuant to the requirements of the Securities Exchange Act of 1934, as amended, the registrant has duly caused this report to be signed on its behalf by the undersigned, hereunto duly authorized.

 

  ADAPTIMMUNE THERAPEUTICS PLC
     
Date: November 6, 2019 By: /s/ Margaret Henry
    Name: Margaret Henry
    Title: Corporate Secretary

 

 

 

 EX-99.1 2 tm1921910d1_ex99-1.htm EXHIBIT 99.1

 

Exhibit 99.1

 

 

Adaptimmune Reports Third Quarter 2019 Financial Results and Business Update

 

- Clinical responses with ADP-A2M4 in 7 out of 12 patients with synovial sarcoma, and clinical benefit in 11 out of 12 patients -

 

- ADP-A2M4 granted Orphan Drug Designation for treatment of soft tissue sarcomas -

 

- Enrolling across SPEARHEAD-1 and SURPASS trials at multiple sites -

 

- Progress towards commercializing ADP-A2M4 for patients with synovial sarcoma in 2022 -

 

- Progressed to third cohort in ADP-A2AFP trial in liver cancer -

 

- Michael Garone appointed as Interim Chief Financial Officer -

 

- Financial guidance confirmed: funded through Q3 2020 -

 

- Conference call to be held today at 8:00 a.m. EST (1:00 p.m. GMT) -

 

PHILADELPHIA, PA., and OXFORDSHIRE, U.K., November 6, 2019 (GLOBE NEWSWIRE) -- Adaptimmune Therapeutics plc (Nasdaq:ADAP), a leader in T-cell therapy to treat cancer, today reported financial results and business highlights from Q3 2019.

 

“The sarcoma community has been very supportive following the ESMO presentation in which we showed a clear benefit for ADP-A2M4. This increases our confidence that we can accelerate enrollment in SPEARHEAD-1 as we progress toward commercialization in 2022,” said Adrian Rawcliffe, Adaptimmune’s Chief Executive Officer. “We continue to see evidence of antitumor activity with our SPEAR T-cells across other indications. We are executing with our ADP-A2AFP trial, now dosing in Cohort 3, as well as our next-gen SURPASS trial, and we plan on updating data throughout 2020. We continue to prioritize resources to enable us to deliver data from our ongoing trials.”

 

COMMERCIAL READINESSS FOR ADP-A2M4 IN SARCOMA WITH AIM TO LAUNCH IN 2022

 

·Data presented at ESMO 2019 demonstrating a clear benefit of ADP-A2M4 for patients with synovial sarcoma showing:

 

oOverall response rate of 58% with 7 out of 12 evaluable patients with clinical responses

 

oDisease control rate (best overall responses of partial response or stable disease) of 92% with 11 out of 12 evaluable patients showing clinical benefit

 

oThese data will be updated at CTOS on November 16th

 

·Enrolling patients in SPEARHEAD-1 (Phase 2 trial in synovial sarcoma and myxoid/ round cell liposarcoma) across several leading clinical trial centers

 

·US FDA granted Orphan Drug Designation to SPEAR T-cells targeting MAGE-A4 (the ADP-A2M4 program) for the treatment of soft tissue sarcomas

 

·Produced first in-house GMP viral vector batch, augmenting the Company’s external supply with internal manufacturing capabilities

 

FOCUSED ON EXECUTION IN OTHER CLINICAL TRIALS

 

·Dosing in the SURPASS trial with ADP-A2M4CD8 – the first next-generation trial at several clinical trial centers with data updates anticipated in 1H 2020

 

oPreclinical data show that these next-generation SPEAR T-cells may improve long term T-cell function as well as antitumor activity

 

·Enrolling in Cohort 3 in the ADP-A2AFP trial in liver cancer at target doses of 5 billion SPEAR T-cells (range 1.2 to 6 billion), after Safety Review Committee endorsed dose escalation
   
 ·Continuing enrollment in the radiation sub-study of the Phase 1 ADP-A2M4 trial

 

·Based on emerging translational data to be presented at SITC on November 8th, will initiate a clinical trial combining ADP-A2M4 with a PD-1 pathway inhibitor in 2020

 

1

 

 

Preclinical progress

 

·Continued progress with stem-cell derived allogeneic program, which is applicable to all T-cells (including both CAR-T and TCR T-cells) with data updates next year

 

·Initiated collaboration with Noile-Immune to develop further next-generation products

 

Other corporate news

 

·Michael Garone appointed as Interim Chief Financial Officer

 

·The Company is recruiting for a permanent Chief Medical Officer and Chief Financial Officer

 

2

 

 

Financial Results for the three-month period ended September 30, 2019

 

·Cash / liquidity position: As of September 30, 2019, Adaptimmune had cash and cash equivalents of $39.4 million and Total Liquidity1 of $102.9 million. The Company also received $15.8 million for UK R&D Tax Credits in October 2019.

 

·Revenue: Revenue for the three and nine months ended September 30, 2019 was $0.2 million and $0.4 million respectively, compared to $40.8 million and $58.0 million for the same periods in 2018. The revenue in the three and nine months ended 2019 is due to the commencement of development under the third target nominated by GSK under the Collaboration and License Agreement, whereas the development and license revenue for the same periods in 2018 was recognized due to the performance under the NY-ESO transition program and the PRAME development plan, which were completed in 2018.

 

·Research and development (R&D) expenses: R&D expenses for the three and nine months ended September 30, 2019 were $29.6 million and $77.1 million, respectively, compared to $23.5 million and $75.5 million for the same periods of 2018. The three and nine month periods ended September 30, 2019 include the impact of recognized purchase commitments for clinical materials of $5.0 million, and in process research and development payments relating to the collaboration agreements with Alpine Immune Sciences, Inc of $2.0 million in May 2019 and Noile-Immune Biotech, Inc of $2.5 million in August 2019. These increases were partially offset by a decrease in share-based compensation expense due to option forfeitures in both periods, an increase in reimbursements for research and development tax and expenditure credits in both periods, and, during the nine months ended September 30, 2019, a reduction in expenditure associated with the NY-ESO program, which was transferred to GSK on July 23, 2018.

 

·General and administrative (G&A) expenses: G&A expenses for the three and nine months ended September 30, 2019 were $10.7 million and $32.7 million respectively, compared to $10.3 million and $32.8 million for the same periods of 2018.

 

·Other income (expense), net: Other income (expense), net for the three and nine months ended September 30, 2019 was income of $0.3 million and an expense of $0.6 million respectively, compared to expenses of $2.2 million and $10.5 million for the same periods of 2018. Other income (expense), net primarily comprises unrealized foreign exchange losses, which fluctuate depending on exchange rate movements and the amount of foreign currency assets and liabilities. Management determined that, effective from July 1, 2019, an intercompany loan was of a long-term investment nature and therefore, from that date, foreign exchange differences on this intercompany loan have subsequently been reported within other comprehensive income (loss).

 

·Net (loss) income: Net (loss) income attributable to holders of the Company’s ordinary shares for the three and nine month periods ended September 30, 2019 was losses of $39.3 million and $107.8 million respectively, and $(0.06) and $(0.17) per ordinary share respectively, compared to income of $5.2 million and a loss of $59.3 million respectively, and $0.01 and $(0.10) per ordinary share respectively in the same periods of 2018.

 

 

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.

 

3

 

 

Financial guidance

 

The Company believes that its existing cash, cash equivalents and marketable securities will fund the Company’s current operations through the third quarter of 2020. As further detailed in the Company’s Quarterly Report on Form 10-Q for the fiscal quarter ended September 30, 2019, to be filed with the Securities and Exchange Commission following this earnings release, the Company has evaluated whether there are conditions and events, considered in the aggregate, that raise substantial doubt about the Company’s ability to continue as a going concern within one year after the date the financial statements are issued. The Company concluded that there are factors that raise substantial doubt about its ability to continue as a going concern for at least one year from the issuance of the September 30, 2019 quarterly condensed consolidated financial statements. In the immediate future, the Company plans to continue to prioritize and review ongoing clinical development projects and costs with the aim of focusing operations on the ADP-A2M4 SPEARHEAD-1, ADP-A2M4CD8 SURPASS, and ADP-A2AFP trials. The Company believes that a combination of targeted clinical progress together with accessing additional capital and/or cost reductions will enable the Company to continue as a going concern for the next twelve months. The Company’s financial results are presented as though it would continue as a going concern.

 

Conference Call and Webcast Information
The Company will host a live teleconference at 8:00 a.m. EST (1:00 p.m. GMT) today, November 6, 2019. The live webcast of the conference call will be available in the investor section 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, please dial (833) 652-5917 (U.S. 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 (3997944).

 

About Adaptimmune

Adaptimmune is a clinical-stage biopharmaceutical company focused on the development of novel cancer immunotherapy products for cancer patients. 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. For more information, please visit http://www.adaptimmune.com.

 

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 Securities and Exchange Commission (SEC) on August 1, 2019 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.

 

4

 

 

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. Each of these components appears 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 thousands):

 

   September 30,   December 31, 
   2019   2018 
Cash and cash equivalents  $39,409   $68,379 
Marketable securities   63,451    136,755 
Total Liquidity  $102,860   $205,134 

 

The Company believes that the presentation of Total Liquidity provides useful information to investors because management reviews Total Liquidity as part of its management of overall liquidity, financial flexibility, capital structure and leverage.

 

5

 

 

Condensed Consolidated Statement of Operations

(unaudited, in thousands, except per share data)

 

   Three months ended   Nine months ended 
   September 30,   September 30, 
   2019   2018   2019   2018 
Development revenue   237    1,678    394    18,912 
License revenue   —    39,114    —    39,114 
Total revenue  $237   $40,792   $394   $58,026 
Operating expenses                    
Research and development (including losses accrued on firm purchase commitments of $5,000, $-, $5,000 and $-)   (29,617)   (23,484)   (77,147)   (75,500)
General and administrative   (10,741)   (10,290)   (32,662)   (32,785)
Total operating expenses   (40,358)   (33,774)   (109,809)   (108,285)
Operating (loss) income   (40,121)   7,018    (109,415)   (50,259)
Interest income   615    606    2,324    1,805 
Other income (expense), net   291    (2,249)   (556)   (10,525)
(Loss) income before income taxes   (39,215)   5,375    (107,647)   (58,979)
Income taxes   (87)   (133)   (154)   (362)
Net (loss) income attributable to ordinary shareholders  $(39,302)  $5,242   $(107,801)  $(59,341)
                     
Net (loss) income per ordinary share - Basic and diluted                    
Basic  $(0.06)  $0.01   $(0.17)  $(0.10)
Diluted   (0.06)   0.01    (0.17)   (0.10)
                     
Weighted average shares outstanding:                    
Basic   630,866,800    582,004,954    629,403,293    573,796,275 
Diluted   630,866,800    621,764,201    629,403,293    573,796,275 

 

6

 

 

Condensed Consolidated Balance Sheets

(unaudited, in thousands, except share data)

 

   September 30,   December 31, 
   2019   2018 
Assets          
Current assets          
Cash and cash equivalents  $39,409   $68,379 
Marketable securities - available-for-sale debt securities   63,451    136,755 
Accounts receivable, net of allowance for doubtful accounts of $0 and $0   —    192 
Other current assets and prepaid expenses (including current portion of clinical materials)   44,110    25,769 
Total current assets   146,970    231,095 
           
Restricted cash   4,318    4,097 
Clinical materials   2,485    3,953 
Operating lease right-of-use assets, net of accumulated amortization   20,563    — 
Property, plant and equipment, net of accumulated depreciation of $20,818 (2018: $15,924)   31,641    36,118 
Intangibles, net of accumulated amortization   2,274    1,473 
Total assets  $208,251   $276,736 
           
Liabilities and stockholders’ equity          
Current liabilities          
Accounts payable   5,535    4,083 
Operating lease liabilities, current   2,337    — 
Accrued expenses and other accrued liabilities   26,846    20,354 
Deferred revenue   2,683    — 
Total current liabilities   37,401    24,437 
           
Operating lease liabilities, non-current   22,599    — 
Other liabilities, non-current   568    5,414 
Total liabilities   60,568    29,851 
           
Stockholders’ equity          
Common stock - Ordinary shares par value £0.001, 785,857,300 authorized and 630,952,736 issued and outstanding (2018: 701,103,126 authorized and 627,454,270 issued and outstanding)   943    939 
Additional paid in capital   583,065    574,208 
Accumulated other comprehensive loss   (10,025)   (9,763)
Accumulated deficit   (426,300)   (318,499)
Total stockholders' equity   147,683    246,885 
           
Total liabilities and stockholders’ equity  $208,251   $276,736 

 

7

 

 

Condensed Consolidated Cash Flow Statement

(unaudited, in thousands)

 

   Nine months ended 
   September 30, 
   2019   2018 
Cash flows from operating activities          
Net loss  $(107,801)  $(59,341)
Adjustments to reconcile net loss to net cash used in operating activities:          
Depreciation   5,406    5,248 
Amortization   511    464 
Share-based compensation expense   8,495    12,453 
Realized (gain) loss on available-for-sale debt securities   (13)   2,473 
Unrealized foreign exchange losses   522    4,921 
Other   (195)   262 
Changes in operating assets and liabilities:          
Increase in receivables and other operating assets   (20,075)   (4,140)
Decrease in non-current operating assets   1,468    490 
Increase (decrease) in payables and deferred revenue   11,703    (35,533)
Net cash used in operating activities   (99,979)   (72,703)
           
Cash flows from investing activities          
Acquisition of property, plant and equipment   (1,425)   (3,823)
Acquisition of intangibles   (1,036)   (666)
Maturity or redemption of marketable securities   92,803    114,988 
Investment in marketable securities   (19,080)   (75,545)
Net cash provided by investing activities   71,262    34,954 
           
Cash flows from financing activities          
Proceeds from issuance of common stock, net of issuance costs of $0 and $347   —    99,653 
Proceeds from exercise of stock options   366    2,933 
Net cash provided by financing activities   366    102,586 
           
Effect of currency exchange rate changes on cash, cash equivalents and restricted cash   (398)   4,111 
Net (decrease) increase in cash and cash equivalents   (28,749)   68,948 
Cash, cash equivalents and restricted cash at start of period   72,476    88,296 
Cash, cash equivalents and restricted cash at end of period  $43,727   $157,244 

 

8

 

 

Adaptimmune Contacts:

 

Media Relations:

 

Sébastien Desprez — VP, Communications and Investor Relations

T: +44 1235 430 583

M: +44 7718 453 176

Sebastien.Desprez@adaptimmune.com

 

Investor Relations:

 

Juli P. Miller, Ph.D. — Senior Director, Investor Relations

T: +1 215 825 9310

M: +1 215 460 8920

Juli.Miller@adaptimmune.com

 

9

 

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Cover
Nov. 06, 2019
Cover [Abstract]  
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Document Period End Date Nov. 06, 2019
Entity File Number 1-37368
Entity Registrant Name ADAPTIMMUNE THERAPEUTICS PLC
Entity Central Index Key 0001621227
Entity Tax Identification Number 00-0000000
Entity Incorporation, State or Country Code X0
Entity Address, Address Line One 60 Jubilee Avenue
Entity Address, Address Line Two Milton Park
Entity Address, City or Town Abingdon, Oxfordshire
Entity Address, Country GB
Entity Address, Postal Zip Code OX14 4RX
City Area Code 44
Local Phone Number 1235 430000
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Pre-commencement Tender Offer false
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Title of 12(b) Security American Depositary Shares, each representing 6 Ordinary Shares, par value £0.001 per share
Trading Symbol ADAP
Security Exchange Name NASDAQ
Entity Emerging Growth Company false

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