Arqule 903396 Nanotechnologie mit viel Potenzial

Das Biotechunternehmen habe mit den Konzernen Bayer und Pfizer zweit große Namen an seiner Seite. ArQule forsche durch die Kombination verschiedener Moleküle nach neuen Wirkstoffen für schwere und bis dato nur unzureichend behandelbare Krankheiten. Erste Erfolge habe man bereits erzielen können. Der Forschungspartner Pfizer habe dem Biotechunternehmen zuletzt früher als geplant eine Zahlung für das Erreichen erster Meilensteine geleistet.

ArQule habe daher die bisherigen Umsatz- und Ergebnisprognosen für das Geschäftsjahr 2003 nach oben nehmen können. Das Unternehmen rechne nun mit Umätzen zwischen 63 Mio. und 65 Mio. USD und mit einem Verlust zwischen 29 und 31 Mio. USD. Bei letzterem habe man zuvor noch ein Minus von 37 Mio. bis 39 Mio. USD erwartet. In der letzten Woche habe man die Kooperation mit Wyeth Pharma verkünden können, was dem Unternehmen weitere Finanzmittel zufließen lasse.

Nach Erachten der Wertpapierexperten stehe ArQule, im Vergleich zu den vielen Konkurrenten aus der Branche, unmittelbar vor dem Sprung in die Gewinnzone. Der Markt habe nun das Potenzial des Titels erkannt. Zuletzt habe die Aktie neue 52-Wochen-Hochs erzielen können.

Die Experten vom " Global Biotech Investing" bewerten die ArQule-Aktie mit " strong buy" , bei einem Kurspotenzial von 100%. Das Stop-loss sollte bei 3,50 EUR platziert werden.





" Nanotech: Chance auf 100 Prozent!


Wer im Bereich Nanobiotechnologie eine weitere Ergänzung sucht, sollte sich laut „Global Biotech Daily“ einige Stücke dieses Wertes ins Depot legen: Der Kurs der Aktie kommt erst jetzt in Fahrt und erste Erfolge zeichnen sich ab: Während Biophan sich zuletzt verdreifachte, stieg die hier besprochene ArQule (WKN 903396) seit Dezember erst knapp 25 Prozent. ArQule hat mit Bayer und Pfizer zwei Pharma-Riesen an seiner Seite und forscht unter Zugrundelegung der Kombination verschiedener Moleküle nach neuen Wirkstoffen gegen schwere Krankheiten. Nach ersten Erfolgen hat Pfizer nun wesentlich früher als ursprünglich geplant eine Zahlung für das Erreichen erster Meilensteine geleistet. Dadurch konnten die bisherigen Umsatz- und Ergebnisschätzungen für 2003 nach oben korrigiert werden. Beim Umsatz werden nun zwischen 63 und 65 Millionen US-Dollar und beim Verlust zwischen 29 und 31 Millionen Dollar erwartet, nachdem zuvor noch von 37 bis 39 Millionen Fehlbetrag ausgegangen worden war. Gestern meldete ArQule den Experten zufolge das Erreichen eines weiteren Meilensteins in der Zusammenarbeit mit Wyeth Pharma. Insbesondere ist hervorzuheben, dass ArQule im Gegensatz zu vielen anderen aus der Branche unmittelbar vor dem Sprung in die Gewinnzone steht: Ohne die Einmalbelastungen von 30,4 Millionen Dollar für die Übernahme von Cyclis im dritten Quartal hätte das Unternehmen wohl schon per 2003 eine schwarze Null verbucht. „Global Biotech Daily“ stuft ArQule vor den genannten Hintergründen mit einem klaren Strong Buy und einem Kurspotenzial von 100 Prozent ein. Der Empfehlungskurs beträgt 5 Euro, bei 3,50 Euro wird zu einem Stopp-loss geraten."

www.boersenwelt.de/xist4c/web/...auf-100-Prozent-_id_2972_.htm


Meine meinung: Meines erachtens ist arqule in nächster zeit sehr vielversprechend und dürfte schnell auf die 10 hinaufklettern, da die aktie noch großen nachholbedarf hat im vergleich zu anderen nanoaktien die meist schon gut gelaufen sind.außerdem schaut es aus fundamentaler und charttechnischer sicht sehr gut aus und die pipeline ist auch sehr sehr vielversprechen!!
informiert euch selber und macht euch ein bild.

gruß max

die konsilidierung ist bei arqule jetzt abgeschlossen. von nun an geht es richtung norden! haltet euch fest!!

gruß max

was ist eure meinung zu der aktie?

gruß max

Schade, dass so wenige bis jetzt auf Arqule aufmerksam geworden sind.

Wie oben geschrieben, wenn auch letztes Jahr wohl nicht die schwarze null geschrieben wurde, werden die Zahlen wohl doch gut ausschauen.
Dieses Jahr wird dann vorraussichtlich der Break even geschafft werden.
Auf 1-2 Jahressicht können die 10 € drin sein.
Wenn mehr auf Arqule aufmerksam werden wohl schon sehr viel früher.

Am 12. Feb. werden die Zahlen bekanntgegeben. Bin gespannt was dann passiert.

Greetz

BillyT.

also ich glaube arqule wird schon in den nächsten wochen von großen kursanstiegen profitieren.und die zahlen werden meiner meinung auch noch einmal für einen richtigen kursanstieg sorgen.

gruß max

jetzt nimmt die aktie doch langsam fahrt auf.
gefällt mir.im mmoment knappe 5 % im plus.

gruß max

...ArQule schläft scheinbar gerade und macht dabei kleine Schritte zurück...

Warum sind die 7,7 % nach unten in Amerika?

Greetz

BillyT.

For the year ended December 31, 2003, ArQule's revenues were $65,539,000, compared with revenues of $62,812,000 for the year ended December 31, 2002. The Company reported a net loss for the year ended December 31, 2003 of $34,751,000, or $1.43 per share. This compares with a net loss of $77,875,000, or $3.67 per share, for the year ended December 31, 2002. The 2003 net loss includes an in-process research and development charge related to the acquisition of Cyclis Pharmaceuticals of $30,359,000, in addition to the above-mentioned restructuring and investment write-down charges (in the aggregate, $5,989,000). The 2002 net loss figures include the effect of the above-mentioned charges.

As announced in December 2003, revenues for the fourth quarter and full year 2003 include revenues from Pfizer that had been anticipated in January 2004. These revenues were related to the achievement of certain goals and deliverables by ArQule.

ArQule ended the year with $77 million of cash and marketable securities. This figure includes a $3 million equity investment that Pfizer made in 2003 as a milestone in acknowledgement of ArQule meeting all of its 2003 deliverables.

"These results provide a very solid base on which to continue ArQule's transition to becoming an innovative, well-financed, oncology-focused biotechnology company," said Dr. Stephen A. Hill, President and CEO of ArQule. "Our cash position at the end of 2003 will allow us to dedicate approximately $25 million per year over the next three years to our Activated Checkpoint Therapy(SM) (ACT(SM)) research and development program. This will include our lead program, ARQ 501, currently in a Phase 1 clinical trial. It will also support our multiple pipeline programs for compounds within our ACT(SM) portfolio, some of which have already commenced animal testing. As will be described below, we will continue during 2004 to strengthen our position as an effective oncology company."

Research and Development Program Update

Activated Checkpoint Therapy(SM) Platform

ArQule's lead program, ARQ 501, is progressing according to plan. In the Phase 1 dose- escalation study, the fifth patient has been safely dosed. Dose- limiting toxicity has yet to be reached. The Company is also in the planning stage for potential new studies that would explore the effect of combinations of ARQ 501 with approved chemotherapeutic agents in specific human tumor types. The Company has increased the resources applied to its next generation of compounds directed to a number of innovative biological targets within the ACT(SM) pathways. During the course of 2004, ArQule will continue this process of reallocating resources away from some of its traditional activities in favor of greater support of its ACT(SM) research and development.

"We are delighted with the progress with ARQ 501 and very excited about our pipeline programs within the ACT(SM) platform. We have fine opportunities to further advance these programs in 2004," said Dr. Chiang Li, ArQule's Chief Scientific Officer and Vice President, Head of ArQule's Biomedical Institute.

Other Programs

The Company is currently exploring out-licensing opportunities for its ion channel and p38 MAP Kinase inhibitor programs. These have reached lead optimization and GLP toxicity phases, respectively. ArQule was pleased to receive a milestone payment from Wyeth on the submission of an IND derived from its Directed Array(TM) collaboration with them. A second program for which ArQule could be eligible for milestone and royalty payments continues to progress through GLP toxicity studies at Solvay.

Chemical Technologies

ArQule continues to have a productive relationship with Pfizer. In response to Pfizer's evolving needs for chemistry support, ArQule has reduced its overall file enrichment effort and re-focused some of its resources to support rapid hit follow up. Instead of increasing its infrastructure to support the required expansion of the original agreement in subsequent years, ArQule will maintain the 2004 compound production levels for potentially the remaining term of the agreement. The revenue and expense consequences of this change are described more fully below in the Company's 2004 guidance.

2004 Financial Guidance

As previously reported, due to the successful achievement of certain goals during 2003, payments originally anticipated from Pfizer in January 2004 were received in December 2003. In addition, the Company's three-year, $30 million collaboration with Bayer was successfully concluded during 2003. On February 11, 2004, ArQule entered into a new agreement with Pfizer. This amends the previous collaboration agreement dated December 18, 2001. Under the terms of the amended agreement, based on the Company's achievement of production milestones, ArQule may receive up to $184.9 million in cash from 2004 through 2008. This potentially represents a total of $291.2 million in cash for the entire collaboration, down from $345 million as previously disclosed. For 2004, expense guidance assumes a reduction in resources needed to support the Pfizer alliance, while increasing the resources available for internal research. As a consequence of the skill-set needs in discovery research, this reallocation will result in the departure of up to 55 current employees through a reduction in force now being implemented and the recruitment of a number of new employees with the skills necessary for oncology research and development activities. All costs related to this realignment are included in the Company's expense guidance for 2004. As stated, ArQule does not anticipate a significant change to the total headcount for ArQule during 2004.

For 2004, ArQule expects revenues to range between $46 and $48 million, total cost of revenue to range between $34 and $35 million, total research and development expenses to range between $22 and $23 million and total marketing, general and administrative expenses to range between $9 and $10 million. The Company expects net investment income to range between $400,000 and $600,000. The Company expects to record a charge of between $1.2 and $1.4 million in the first quarter of 2004 associated with its decision to terminate approximately 55 employees. ArQule expects its net loss per share to range between $0.66 and $0.70 for the year. ArQule expects its net use of cash this year to range between $29 and $31 million, of which approximately $6 million will be spent on paying down debt on the building in Woburn. This guidance does not assume any additional collaborations, acquisitions or in-licensing initiatives.

"Our guidance for 2004 reflects our confidence in the strength of our oncology programs. We are well positioned to resource those programs effectively for a number of years," concluded Dr. Hill.

ArQule will hold a conference call at 9:00 a.m. Eastern Time. Dr. Stephen A. Hill, President and CEO, and Louise A. Mawhinney, CFO, will lead the call.

    Date:                         Thursday, February 12, 2004
    Time:                         9:00 a.m. ET

    Conference Call Numbers
    Toll Free:                    (800) 289-0437
    Toll:                         (913) 981-5508
    Webcast:                      www.ArQule.com

A replay of the conference call will be available for five days and can be accessed by dialing toll-free (888) 203-1112, and outside the U.S. (719) 457- 0820. The access code is 672491.

ArQule, Inc. is a biotechnology company engaged in research and development of next-generation small-molecule cancer therapeutics based on its innovative Activated Checkpoint Therapy(SM) (ACT(SM)) platform. ACT(SM) compounds are intended to improve the way cancer patients are treated because they selectively kill cancer cells and spare normal cells by restoring and activating cellular checkpoints that are defective in cancer. The Company's lead programs are ARQ 501 for solid cancers, presently in Phase 1 clinical trials, and ARQ 101, an optimized small-molecule compound targeting p38 MAP Kinase for rheumatoid arthritis, presently in preclinical (GLP-tox) studies. In addition to advancing its own programs, ArQule continues to advance the drug discovery efforts of pharmaceutical collaborators by providing high- quality library design and compound production. For more information about ArQule, please visit the Company's new website at www.ArQule.com.

This press release contains forward-looking statements as defined in the Private Securities Litigation Reform Act of 1995 ("Reform Act"), which provides a safe harbor for forward-looking statements made by or on behalf of ArQule. ArQule and its representatives may from time to time make written or oral forward-looking statements, including statements contained in this press release. Generally, the words "believe," "expect," "intend," "estimate," "anticipate," "will" and similar expressions identify forward-looking statements. All statements which address operating performance, events or developments that ArQule expects or anticipates will occur in the future, such as projections about its future results of operations or its financial condition, research, development and commercialization of its products and anticipated trends in its business are forward-looking statements within the meaning of the Reform Act.

Actual results may differ materially from those projected in the forward- looking statements or historical performance due to numerous risks and uncertainties that exist in ArQule's operations, development efforts and the business environment, including without limitation: ARQ 501 may fail in clinical trials; possible delays in clinical trials; the ability to commercialize product candidates if ArQule fails to demonstrate adequately their safety and efficacy; the ability of its competitors to develop and market cancer products that are more effective and have fewer side effects; the ability to integrate successfully ArQule's biology experience and the ACT(SM) platform with its small-molecule chemistry expertise; the ability to improve the treatment of cancer patients; the ACT(SM) platform may not improve efficacy or reduce toxicity and compounds resulting from the platform may not operate as intended; the ACT(SM) pipeline may prove disappointing; payments may not be received on a timely basis resulting in inaccuracies of the financial projections contained herein; costs associated with the reduction in force may exceed expectations; ArQule may not achieve its production milestones in its collaboration with Pfizer and its revenue projections may fall short; the Company may not be able to attract and retain an adequate number of new employees with appropriate skills; and, the risks and uncertainties described in ArQule's Form 10-K filed with the Securities and Exchange Commission on March 31, 2003, its Form S-3 filed with the Commission on October 8, 2003 and its Form 10-Q filed with the Commission on November 12, 2003. The forward-looking statements contained herein represent the judgment of ArQule as of the date of this report. ArQule disclaims any intent or obligation to update any forward-looking statement except to the extent required by law.


                       -- financial tables follow --




                                 ArQule, Inc.
                       Condensed Statement of Operations
                   (In Thousands, Except Per Share Amounts)

                                   Three Months Ended   Twelve Months Ended
                                       December 31          December 31
                                       (Unaudited)          (Unaudited)
                                          2003       2002      2003       2002
   Revenue:
          Compound development
           revenue                  $17,981    $15,773   $65,077    $60,965
          Compound development
           revenue - related
           parties                       462        381       462      1,847
             Total revenue          18,443     16,154    65,539     62,812

   Costs and expenses:
          Cost of revenue               8,991      8,794    36,060     35,231
          Research and development  6,072      7,140    18,932     31,389
          Marketing, general and
           administrative                 2,395      2,608     9,560     12,876
          Stock-based compensation    -          376       -        3,221
          Amortization of
           intangibles                      -          841       -        3,373
          Impairment of core
           technology                      -       17,137       -       17,137
          Impairment of goodwill           -       25,890       -       25,890
          Restructuring charges          1,529     12,695     1,239     12,695
          In-process research and
           development                      -          -      30,359        -
             Total costs and
              expenses                    18,987     75,481    96,150    141,812

             Loss from operations      (544)   (59,327)  (30,611)   (79,000)

   Net interest income                  165        223       610      1,125
   Loss on investment                (4,750)       -      (4,750)       -

             Net loss               $(5,129)  $(59,104) $(34,751)  $(77,875)

   Basic and diluted net loss per
    share (A)                        $(0.18)    $(2.78)   $(1.43)    $(3.67)

   Weighted average common shares
    outstanding - basic and diluted  28,141     21,283    24,333     21,215


   (A) Basic and diluted net loss per share amounts were equal in
       all periods presented.



                               December 31,  December 31,


   Balance sheet data
    (in thousands):                  2003       2002

          Cash, cash equivalents
           and marketable
           securities               $76,724    $85,626
          Working capital            54,698     54,176
          Total assets              128,424    145,079
          Stockholders' equity       86,477     93,715


   ArQule Contacts:
    Stephen Hill, CEO
    Louise Mawhinney, CFO
    (781) 994-0300
    www.ArQule.com

SOURCE ArQule, Inc. -0- 02/12/2004 /CONTACT: Stephen Hill, CEO or Louise Mawhinney, CFO of ArQule, +1-781-994-0300 / /Web site: www.arqule.com/ (ARQL) CO: ArQule, Inc. ST: Massachusetts

Phase 1 results for ARQ-501 will be presented at AACR-NCI-EORTC meeting in Geneva and at the same time at UBS Global Life Sciences, NY 29.Sep.04 08.00 EST.

05.Oct.04 ArQule's Analyst Day
What's Next- Cancer Therapeutics in the 21st Century

übrigens: ARQ-501 (beta-lapachone):
1. wird durch NQO1 Expression in Zellen aktiviert. Viele Krebszellen haben dieses Enzym bis zu 50 fach überexprimiert. Die effektive Dosis wird dadurch auf ca. 30% reduziert.
2. wirkt unabhängig von p53. Viele Krebszellen haben diesen Apoptose-Pathway ausgeschaltet und sind darum so resistent.
3. wirkt unabhängig von den bekannten Resistenzmechanismen, wie z.B. MDR (multi drug resistance).
4. kann unabhängig von Caspasen Apoptose auslösen, z.B. durch neu entdeckte calpain pathways.
5. ist das erste Medikament, das nicht irgendwas hemmt, sondern einen natürlichen, evolutionär hoch konservierten, E2F-abhängigen Mechanismus zur Aktivierung von Kontrollpunkten (checkpoints) im Zellzyklus nutzt, um Krebszellen selektiv ohne DNA Schädigung durch multiple zellabhängige/ zelleigene Apoptosewege und dosisabhängig Nekrose abzutöten.
6. wird in Kombination mit z.B. Taxol 10 mal effektiver.
7. hat fast keine Nebenwirkungen. Normale, gesunde Zellen werden kontrolliert, aber nicht geschädigt.
8. konnte im xenograft Tiermodell 100% der Tumorherde abtöten. Kein Nachwachsen, keine Neoangiogenese.