ADAP: Adaptimmune - Transforming T-Cell therapy

oder sind da schon Seilschaften am Werk?  

auf der Adaptimmune Homepage http://www.adaptimmune.com/clinical-programmes/  

am 17.09 bei Morgan Stanley und Meryl Lynch via IR Seite bei Adaptimmune auch im Nachhinein zu betrachten.  

 

Was ist denn heute los? Ist im webcast etwas gesagt worden, was den Kurs so runterpruegelt?  

geringem Volumen runtergedreht worden. Vom Webcast habe ich nur den letzten Teil der Q&A mitbekommen. Es ging auch um den Todesfall in dem EU-Projekt - die Antwort muss ich mir aber nochmal anhören (nur sinngemäss: der Fall wird noch untersucht, ist nicht direkt mit anderen Adaptimmune Versuchen vergleichbar und der Sponsor wird sich nach Aufklärung der Hintergründe dazu äussern), wenn es denn eine Aufzeichnung zu hören gibt.

Es gab vorab Hinweise, dass die HF sich abstimmen und eine Aktie nach der anderen der Biotechs hochkaufen und dann shorten - Adaptimmune sollte als nächstes kommen. Dies kann ich aber nicht so nachvollziehen, da die Umsätze dafür zu gering sind und hochkaufen ja wohl über dem Ausgabekurs liegen müsste... also abwarten.  

Jetzt reichts doch aber mal...

 

 

für Adaptimmune
als
 "Best Emerging UK Biotech Fundraiser"  
für
"securing funding for the development of modified T-cells carrying affinity enhanced TCRs to target specific cancers."

Glückwunsch... jetzt müsste nur der Kurs wieder stimmen.  

zum Stand und zur möglichen Zukunft der Immunotherapien - speziell zur Auswahl geeigneter TCR und möglichen Kombinationstherapien.
 

passt der Börsenkurs im Moment überhaupt nicht. Und das ist es nunmal, was für Investierte wichtig ist . . .  

und da sind vielleicht einige überrascht, wenn es tatsächlich in 2015 schon Einnahmen aus Meilensteinen von GSK zu vermelden gibt.  

entstehen.
Für 110 Leute in US in den nächsten 3 Jahren und mehr als 200 in UK.

http://www.fiercebiotech.com/story/...ew-cancer-rd-outpost/2015-10-06  

und Webcast... hoffentlich hat das Schlachten dann ein Ende.

 

das was hier abgeht ist schon der Wahnsinn - bin ja mal gespannt, wie die Zahlen und die Reaktion darauf ausfallen. Kann eigentlich nur noch besser werden . . .  

und soll einigen dicke Profite bescheren - vermute ich. Wer bei diesen Kursen hinschmeisst hat m.E. sicher verloren.

Ich werde versuchen auf jeden Fall dabei zu sein und mich nicht durch diese Spielchen abschütteln lassen, selbst auf die Gefahr hin, später noch dümmer auszusehen, wenn es tatsächlich gute Gründe für das Schlachten geben sollten.  

wenn ich es richtig lese müsste Adaptimmune die Markterwartungen von minus $0,08  pro Aktie um 1ct geschlagen haben - ob das reicht um den Trend umzukehren?  

Adaptimmune Reports Full Fiscal Year 2015 Financial Results
12:05 13.10.15

Conference Call to be Held Today at 8:00 AM ET (1:00 PM BST)

PHILADELPHIA, Pa. and OXFORD, UK., October  13, 2015 - Adaptimmune Therapeutics plc (Nasdaq: ADAP), ("Adaptimmune" or the "Company"), a clinical stage biopharmaceutical company focused on the use of T-cell therapy to treat cancer, today reported financial results for the full fiscal year 2015, which ended June 30, 2015.

"This has been a period of exciting progress throughout our organization, marked by execution on key elements of our growth strategy," commented James Noble, Adaptimmune's Chief Executive Officer. "We successfully completed our initial public offering in May, and continued to scale up the organization in the U.S. and U.K. to execute on our clinical development and research priorities. From a clinical perspective, we generated strong momentum in our pipeline of affinity enhanced T-cell therapies and have seen encouraging response rates to our NY-ESO-1 affinity enhanced T-cell therapy, which we are developing with GSK, in Phase I/II trials in patients with solid and hematologic cancers. We have also demonstrated durable persistence and long-term expression of the TCR on the cell surface. Our clinical momentum has also included the approval of our Investigational New Drug (IND) application for our affinity enhanced T-cell therapy targeting MAGE-A10, as well as the start of dosing in our expanded study of our NY-ESO-1 affinity enhanced T-cell therapy in patients with synovial sarcoma. Finally, we have a rapidly growing number of active research programs which puts us in a strong position to deliver our ambitious goal of new INDs each year from 2016 onwards."

Mr. Noble continued, "From a corporate perspective, we have nearly doubled our team since our IPO, having recruited exceptional clinical and manufacturing professionals and expanded our highly skilled research and development team. To accommodate this essential expansion and further growth, we recently announced the commencement of construction for state-of-the-art manufacturing and research facilities in the U.S. and U.K., respectively. This has literally laid a firm foundation for Adaptimmune going forward, enabling us to enter 2016 well placed to deliver key data from our ongoing studies, build clinical experience with our affinity enhanced T-cell therapies, and explore ways to further enhance the rate, depth and durability of responses to them."

Corporate and Clinical Highlights:

Successfully completed IPO and listed on NASDAQ Global Select Market, raising $176 million in net proceeds; current cash is expected to support global operations for  approximately three years;
Initiated dosing in expanded Phase I/II trial of affinity enhanced T-cell therapy targeting NY-ESO-1 in synovial sarcoma patients. Based on encouraging results seen in the first 12 synovial sarcoma patients, the trial has been expanded to include an additional 20 patients in two cohorts, triggering further milestone payments from GSK;
Secured publication of data detailing the persistence, tumor trafficking, antitumor effect and safety profile of Adaptimmune's affinity enhanced T-cell therapy in patients with advanced multiple myeloma in Nature Medicine;
Presented data from ongoing clinical studies with our NY-ESO-1 T-cell therapy across a number of cancer targets at multiple medical conferences, including the American Association for Cancer Research (AACR) 2015 annual meeting, 2015 American Society of Clinical Oncology (ASCO) annual meeting, and the 18th Annual Meeting of the American Society of Gene and Cell Therapy (ASCGT);
Investigational New Drug (IND) application for Phase I/II studies of our MAGE A-10 T-cell therapy filed and now open in the U.S.; dosing  in non-small cell lung cancer study anticipated to start in 2015;
Increased number of research programs for new therapeutic targets from nine to 12; validation of additional targets ongoing toward goal of filing new INDs each year from 2016 onwards.
Continued execution of growth strategy to build out clinical capabilities to support development of clinical and preclinical pipeline; Company grew from 39 full-time equivalent employees as of July 1, 2014 to 190 as of October 9, 2015; and
Signed lease agreements in Philadelphia, PA for new fully integrated office, laboratory and cGMP CMC / manufacturing facility, and in Oxfordshire, UK for new research and development facility.
Full Fiscal Year 2015 Financial Results

Cash position: As of June 30, 2015, Adaptimmune had $284 million (£181 million) in cash, cash equivalents, and asset investments, compared to $46.9 million (£30.1 million) as of June 30, 2014.
Cash Burn: Operating cash outflows were $32.7 million (£20.8 million) related to the growth of Adaptimmune's business, including $23.2 million (£14.7 million) of R&D expenditure.  The overall net increase in cash and cash equivalents of $181.7 million (£115.6 million) and current asset investments of $55.3 million (£35.2 million) in the 12 months ended June 30, 2015 was primarily due to net proceeds on the Series A round and IPO of $275.2 million (£174.7 million).
Revenue: For the fiscal year ended June 30, 2015, revenue was $10.7 million (£6.8 million) compared to $0.6 million (£0.3 million) for full fiscal year 2014. The increase in 2015 was primarily due to a full year of recognition of revenue under the collaboration and license agreement with GSK, which was announced in June 2014.
Research and development (R&D) expense:  Research and development expenses were $23.2 million (£14.7 million) for fiscal year 2015 compared to $11.6 million (£7.4 million) in fiscal year 2014, primarily due to increased costs associated with ongoing NY-ESO-1 TCR clinical trials, evaluation and validation of additional targets, preparing for NSCLC studies with the Company's NY-ESO-1 and MAGE A-10 T-cell therapies, personnel expenses including non-cash stock-based compensation, production costs, costs associated with obtaining patents and other intellectual property, and costs related to the Company's growing operations.
General and administrative (G&A) expense:  General and administrative expenses were $11.3 million (£7.2 million) for fiscal year 2015 compared to $2.5 million (£1.6 million) in fiscal year 2014, primarily due to increased personnel expenses, including non-cash stock-based compensation, and other expenses to support the Company's growing operations, and the requirements of being a public company.
Net loss:  net loss attributable to common stockholders was $21.6 million (£13.7 million), or $(0.07) per ordinary share (or £(0.04) per ordinary share) for fiscal year 2015.
Fiscal Year Transition

Adaptimmune is transitioning from a June 30 fiscal year end to a December 31 fiscal year end to align more closely with sector comparators, and will be changing its accounting standard from International Financial Reporting Standards (IFRS) to U.S. Generally Accepted Accounting Principles (GAAP) starting in January 2016.  The Company will file a form 20-F containing audited financial statements prepared under IFRS covering the period from July 1, 2015 to December 31, 2015 followed by a form 10-K containing audited financial statements prepared under U.S. GAAP covering the calendar year 2016.  As a result, the Company is providing cash burn guidance for the 18 month period between July 1, 2015 and December 31, 2016.  

Financial Guidance

For the six months from July 1, 2015 to December 31, 2015, the Company expects its cash burn to be between $20 and $30 million, excluding cash burn associated with business development activities.  For the full year 2016, the Company expects its cash burn to be between $80 and $100 million, excluding cash burn associated with business development activities, and expects its cash position at December 31, 2016, including cash, cash equivalents, and asset investments, to be at least $150 million.

Conference Call Information

The Company will host a live teleconference and webcast to provide a business update at 8:00 AM ET (1:00 PM BST) today, October 13, 2015. 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 (877) 280-1254 (United States) or +44(0)20 3427 1919 or 0800 279 4992 (United Kingdom). After placing the call, please ask to be joined into the Adaptimmune conference call and provide the confirmation code (7224348).

About Adaptimmune

Adaptimmune is a clinical stage biopharmaceutical company focused on novel cancer immunotherapy products based on its T-cell receptor (TCR) platform.  Established in 2008, the Company aims to utilize the body's own machinery - the T-cell - to target and destroy cancer cells by using engineered, increased affinity TCRs as a means of strengthening natural patient T-cell responses. Adaptimmune's lead program is an affinity enhanced T-cell therapy targeting the NY-ESO cancer antigen. Its NY-ESO TCR affinity enhanced T-cell therapy has demonstrated signs of efficacy and tolerability in Phase 1/2 trials in solid tumors and in hematologic cancer types, including synovial sarcoma and multiple myeloma. As of June 30, 2015, 85 patients had been treated with Adaptimmune's NY-ESO affinity enhanced T-cell therapy: 47 under Adaptimmune's IND, and 38 under a National Cancer Institute IND. In June 2014, Adaptimmune announced that it had entered into a strategic collaboration and licensing agreement with GlaxoSmithKline (GSK) for the development and commercialization of the NY-ESO TCR program in partnership with GSK.  In addition, Adaptimmune has a number of proprietary programs and its next affinity enhanced T-cell therapy, directed at MAGE A-10, is scheduled to enter the clinic in 2015. The Company has identified over 30 intracellular target peptides preferentially expressed in cancer cells and is currently progressing 12 of these through unpartnered research programs.  Adaptimmune has over 190 employees and is located in Oxfordshire, UK and Philadelphia, USA.  For more information:  http://www.adaptimmune.com

Forward-Looking Statements

This press release contains "forward-looking statements," as that term is defined under the Private Securities Litigation Reform Act of 1995 (PSLRA), which statements may be identified by words such as "believe," "may", "will," "estimate," "continue," "anticipate," "intend," "expect" and other words of similar meaning. 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; our ability to submit an IND and successfully advance our technology platform to improve the safety and effectiveness of our existing TCR therapeutic candidates; the rate and degree of market acceptance of T-cell therapy generally and of our TCR therapeutic candidates; government regulation and approval, including, but not limited to, the expected regulatory approval timelines for TCR therapeutic candidates; and our ability to protect our proprietary technology and enforce our intellectual property rights; amongst others. 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 Prospectus filed with the Securities and Exchange Commission on May 7, 2015. We urge you to consider these factors carefully in evaluating the forward-looking statements herein and are cautioned not to place undue reliance on such forward-looking statements, which are qualified in their entirety by this cautionary statement. 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.  We intend that all forward-looking statements be subject to the safe-harbor provisions of the PSLRA.

Selected Consolidated Statement of Income Year Ended June 30,
(in thousands, except per share data) 2015 2015 2014
   Revenue§ $  10,723 £  6,818 £  355
Costs and Expenses
Research and development expenses  (23,196)  (14,749)  (7,356)
General and administrative expenses  (11,325)  (7,201)  (1,602)
Other income  727  462  165
Operating loss  (23,071)  (14,670)  (8,438)
Other Expense
Finance income  506  322  2
Finance expense  (1,132)  (720)  (4)
Loss before Income tax $  (23,697) £  (15,068) £  (8,440)
  Taxation§  2,105  1,339  982
Net loss $  (21,592) £  (13,729) £  (7,458)
Basic and Diluted loss per share $  (0.07) £  (0.04) £  (0.05)
Weighted average number of shares used to calculate  loss per share:
Basic and diluted 325,012,111 325,012,111 148,484,504


Selected Consolidated Balance Sheet Data Year Ended June 30,
(in thousands, except per share data) 2015 2015 2014
    Assets                                                  §
Non-current assets
Property, plant & equipment $  5,393 £  3,429 £  840
Intangibles§  178  113 -
Total non-current assets $  5,571 £  3,542 £  840
Current assets
Other current assets 102 65 -
Trade and other receivables  6,683  4,249  625
Tax receivable  3,969  2,524  1,027
Current asset investments  55,302  35,164 -
Cash and cash equivalents  229,089  145,666  30,105
Total current assets $  295,145 £  187,668 £  31,757
Total assets $  300,716 £  191,210 £  32,597
Total Cash Position, including current asset investment $  284,391 £  180,830 £  30,105
Equity and liabilities
    Equity                                                  §
Share capital $  668 £  425 £  182
Share premium  179,431  114,091  9,956
Other reserves  126,516  80,445  10,110
Foreign exchange reserve  190  121  110
Retained earnings  (47,164)  (29,989)  (18,943)
Total Equity $  259,642 £  165,093 £  1,415
Non-current Liabilities
Trade and other payables 14,312 9,100 -
Current Liabilities
Trade and other payables  26,723  16,992  31,138
Tax payable  39  25  44
Total current liabilities $  26,763 £  17,017 £  31,138
Total equity and liabilities $  300,716 £  191,210 £  32,597


Consolidated Cash Flows Statements Year Ended June 30,
(in thousands, except per share data) 2015 2015 2014
Cash flows from operating activities
Loss for the year before tax $  (23,697) £  (15,068) £  (8,440)
Adjustments for:
Depreciation§  703  447  148
Amortization§  30  19 -
Loss on disposal of property, plant and equipment  3  2 -
Equity-settled share based payment expense  4,220  2,683  204
Increase in other current assets (102) (65) -
Increase in trade and other receivables  (5,700)  (3,624)  (311)
(Decrease)/increase in trade and other payables  (7,936)  (5,046)  29,539
Foreign exchange translation differences on consolidation 17 11 141
Cash from/(used in) operations  (32,462)  (20,641)  21,281
Net tax (paid)/received  (278)  (177)  578
Net cash from/(used in) operating activities  (32,740)  (20,818)  21,859
Cash flows from investing activities
Acquisition of property, plant & equipment  (4,902)  (3,117)  (851)
Acquisition of intangibles  (208)  (132) -
Proceeds from disposal of property, plant & equipment 124 79 -
Investments in short-term deposits  (55,302)  (35,164) -
Net cash used in investing activities  (60,288)  (38,334) (851)
Cash flows from financing activities
Proceeds from the issue of share capital 274,771 174,713 9,944
Net cash from financing activities 274,771 174,713 9,944
Net increase in cash and cash equivalents 181,743 115,561 30,953
Cash and cash equivalents at start of period 47,346 30,105  (848)
Cash and cash equivalents at year end $  229,089 £  145,666 £  30,105
Adaptimmune Contacts

Will Roberts

Vice President, Investor Relations

T:  (215) 825-9306  

E: will.roberts@adaptimmune.com

Margaret Henry

Head of PR

T: +44 (0)1235 430036

Mob: +44 (0)7710 304249

E: margaret.henry@adaptimmune.com  

"...Cash position: As of June 30, 2015, Adaptimmune had $284 million (£181 million) in cash, cash equivalents, and asset investments, compared to $46.9 million (£30.1 million) as of June 30, 2014.

Cash Burn: Operating cash outflows were $32.7 million (£20.8 million) related to the growth of Adaptimmune's business, including $23.2 million (£14.7 million) of R&D expenditure.  The overall net increase in cash and cash equivalents of $181.7 million (£115.6 million) and current asset investments of $55.3 million (£35.2 million) in the 12 months ended June 30, 2015 was primarily due to net proceeds on the Series A round and IPO of $275.2 million (£174.7 million).

Revenue: For the fiscal year ended June 30, 2015, revenue was $10.7 million (£6.8 million) compared to $0.6 million (£0.3 million) for full fiscal year 2014. The increase in 2015 was primarily due to a full year of recognition of revenue under the collaboration and license agreement with GSK, which was announced in June 2014..."
 

 

624 Seiten (aber viel Formales und Luft) über wohl fast alle Details und ehrenhafter Erwähnung von Medigene als Herkunft und Möchtegern-TCR-Konkurrenz neben Juno und Kite Pharma.
An Risiken wird nicht gespart, aber der Anspruch, das führende TCR T-Zelltherapie Unternehmen zu sein, bleibt.
Herunterzuladen als PDF in der eingereichten Form F-20 mit vielen Anhängen zu den Verträgen mit Immunocore und anderen.  

http://www.nasdaq.com/press-release/...-investor-forum-20151016-00397

Adaptimmune to Participate in the 2015 BIO Investor Forum
By GlobeNewswire,  October 16, 2015, 10:00:00 AM EDT

PHILADELPHIA and OXFORD, United Kingdom, Oct. 16, 2015 (GLOBE NEWSWIRE) -- Adaptimmune Therapeutics plc (Nasdaq:ADAP), ("Adaptimmune" or the "Company"), a clinical stage biopharmaceutical company focused on the use of T-cell therapy to treat cancer, today announced that Helen Tayton-Martin, Chief Operating Officer of Adaptimmune will present at the 2015 BIO Investor Forum at 9:00 AM PDT (5:00 PM BST) on Tuesday October 20, 2015. The conference is being held at the Parc 55 Hotel in San Francisco, Ca.

Adaptimmune's presentation will be webcast live for investors through the investor section of www.adaptimmune.com and available for a period of 30 days following the conference.

In addition, James Noble, Adaptimmune's Chief Executive Officer will be a featured speaker at the 2015 BIO Investor Forum's Fireside Chat at the Plenary Lunch on Tuesday October 20, 2015 at 12:30 PM PDT.

Read more: http://www.nasdaq.com/press-release/...m-20151016-00397#ixzz3oonzIwfn  

immernoch ?

 

Aktien short unter 20% der aktuell via IPO an der Börse handelbaren ADS.
(siehe http://www.nasdaq.com/symbol/adap/short-interest )

Gehandelt wird Adaptimmune ja an der NASDA nur in ADS die je ein ADR repräsentieren, welches mit 6 Eigentümeranteilen hinterlegt ist. 11,5 Millionen ADS wurden an die Börse gebracht und maximal rund 71 Millionen dürften ab dem 2.11 (Ende des Lock-up) insgesamt am Markt sein. Auf letztere hoffen die Shorties vermute ich.

Die Marktkapitalisierung bei einem aktuellen Börsenkurs von etwas über $7 beträgt ca. 500 Millionen US-Dollar - Viele Börseninformationsdienste und Newsletter gehen aber von den in UK eingetragenen 424 Millionen 'Ordinary Shares' als Aktien aus und kommen so zu 6-fach überhöhten Bewertungen von über 3 Milliarden US-Dollar für Adaptimmune.

Um das Chaos komplett zu machen, rechnet auch NASDAQ mal mit ADS und mal mit 'Ordinary shares'. So kommen sie z.B. zu völlig verzerrten Informationen bezüglich der institutionellen Anleger wo sie die gehaltenen ADS wieder gegen die 'ordinary shares' setzen (siehe http://www.nasdaq.com/symbol/adap/institutional-holdings ), zum Vergleich die Angaben aus dem aktuellen Finanzbericht.  

Adaptimmune Therapeutics PLC ? Trading Up 9.8% (ADAP)
Posted by Jim Maxwell on Oct 19th, 2015

Adaptimmune Therapeutics PLC ? (NASDAQ:ADAP) shares were up 9.8% during mid-day trading on Monday , Marketbeat.com reports.
The stock traded as high as $8.13 and last traded at $7.99, with a volume of 491,789 shares. The stock had previously closed at $7.28.
Several research analysts have recently issued reports on ADAP shares. Cowen and Company reissued an ?outperform? rating on shares of Adaptimmune Therapeutics PLC ? in a report on Thursday. Leerink Swann reaffirmed a ?buy? rating and set a $24.00 target price on shares of Adaptimmune Therapeutics PLC ? in a report on Thursday, July 2nd.
The company?s 50 day moving average price is $10.57 and its 200 day moving average price is $14.55. The firm?s market capitalization is $580.44 million...