YM Bio Sciences

Da kamen News früher als ich gedacht habe, bringt den Kurs wieder in die Bahn, einsteigen tu ich trotzdem noch nicht, ist wohl eher eine kurzfristiger Schub?

Nasdaq.com:

YMI: Ph IIb Trial of AeroLEF(TM) for Pain Meets Primary Endpoint

YM BioSciences Inc. (YMI) announced top-line results from its randomized, placebo-controlled Phase IIb trial of AeroLEF(TM) in opioid naive patients with post-operative pain following orthopedic surgery. AeroLEF(TM) met the primary endpoint of the study, showing a statistically significant difference in SPRID4 from placebo.

AeroLEF(TM) is an inhaled-delivery composition of free and liposome-encapsulated fentanyl in development for the treatment of moderate to severe pain, including cancer pain. Unlike fixed dose approaches to opioid delivery, where a significant titration period is often required to determine the suitable dose for the patient, AeroLEF(TM) is being developed as a non-invasive patient self-titrated delivery system designed to enable patients to identify and select a personalized dose for each pain episode, achieving both rapid onset and extended duration of analgesia.

sind doch aber recht gute news.
Aufgrund der aufgeräumten Stimmung am Markt und dem Potenzial denke ich doch, dass dies zu einer nachhaltigen Erholung des Kurses führen könnte.
Werde jedenfalls wieder zukaufen, wenn es kleine Rückschläge geben sollte.

Financial News auf Nasdaq. War auch so zu erwarten, ähnliche Situation wie bei IsoTis, junges Unternehmen, zweistelliges Wachstum in den Umsätzen, aber noch hohe Kosten durch Markteinführung und Lizenzen. Daher macht der Kurs auch keine Turbulenzen auf die Meldung. Der Umsatz hat sich immerhin fast verdreifacht , für ein positives Ergebnis reicht es natürlich noch nicht.



YM BioSciences Q3 Loss Widens On Higher Expenses - Quick Facts


(RTTNews) - Friday, YM BioSciences Inc. (YMI) said its third quarter loss widened from last year, on higher expenses.
Net loss for the third quarter was C$8.93 million or C$0.16 cents per share, wider than year-ago C$5.77 million or C$0.13 cents per share.
Total revenue increased to C$1.98 million from C$0.68 million last year, on the strength of two out-licensing deals signed since March 31, 2006 as well as increased interest income, the company noted.

Total operating expenses for the quarter were C$10.9 million, up from C$6.6 million in the same period last year. The latest quarter expenses included a C$1.8 million non-cash charge for an intangible asset, related to the company's Eximias acquisition on May 9, 2006. Licensing and product development expenses increased to C$7.32 million from C$4.68 million in the prior year period.

Widerstand bei 1.2EUR hat heute vorerst gehalten. Geschlossen dann bei 1.23EUR, jetzt wird's interessant, bei weiterem Abrutschen steig ich wieder ein, zugleich kann ich beobachten, wie sich die Unterstützungen halten. Unter 1.1EUR gibts dan charttechnisch ein Nirvana, das ist auch noch erwähnenswert bzw. man muss es sich bewusst sein.

Habe ein paar wichtige statements fett/untertrichen, kaufe mir wenn sich die Gelegenheit ergibt zwischen 1.05.-1.15EUR, und spekuliere auf positive Studienergebnisse. Im dümmsten Fall dreht der Kurs jetzt recht schnell wieder bevor ich aufsteige, nehm das Risiko auf ein Verpassen in Kauf, denn wenn schlechte News kommen wie bei Tesmilifene, dann "es guets Nächtle". Wenn schon der Kurs in den Keller geht, dann wenigstens nicht auf einem erhötem Niveau. Es wird spannend so oder so


17 May, 2007
YM BIOSCIENCES REPORTS THIRD QUARTER 2006 OPERATIONAL AND FINANCIAL RESULTS



MISSISSAUGA, Canada May 11, 2006 YM BioSciences Inc. (AMEX:YMI, TSX:YM, AIM:YMBA), an oncology company that identifies, develops and commercializes differentiated products for patients worldwide, today reported operational and financial results for the third quarter of fiscal 2007, ended March 31, 2007.

The quarter started with the unfortunate termination of our tesmilifene trial, but continued with the advancement of our other two late-stage products, announcing subsequent to the end of the quarter that our AeroLEF„ phase IIb trial had met its primary endpoint and making progress with nimotuzumab on several fronts within a global group of licensees,€ said David Allan, Chairman and CEO of YM BioSciences. We maintain a solid financial position and remain committed to evaluating additional assets to enhance our product pipeline while ensuring clinical momentum is sustained with our lead products.€


Nimotuzumab:

During the quarter, global development of nimotuzumab through a number of licensees and the licensor of the drug continued in multiple tumour types, including pediatric and adult glioma, pancreatic cancer, prostate cancer, non-small cell lung cancer, esophageal cancer, cervical cancer, and breast cancer.
Daiichi Sankyo Co., Ltd., the Japanese licensee of nimotuzumab, filed and subsequent to the end of the quarter obtained the approval by Japanese regulatory authorities of an IND application to start a Phase I clinical trial of nimotuzumab for the treatment of solid tumours.
Enrollment is expected to be completed during the first half of 2007 in a Phase III trial of nimotuzumab as first-line therapy in pediatric pontine glioma being conducted by Oncoscience AG in Germany.
YM is in the planning stages of a Phase II study in the same indication in the United States and Canada.
YM anticipates filing an IND for a Phase II trial evaluating nimotuzumab in colorectal cancer in the immediate future.


AeroLEF„:

Subsequent to the end of the quarter, YM announced that AeroLEF„ had met the primary endpoint in its randomized, placebo-controlled Phase IIb trial enrolling opioid-naa¯ve patients with post-operative pain following orthopedic surgery. AeroLEF„ demonstrated a statistically significant difference in pain relief and pain intensity to placebo (p=0.0194).
The results of this study will inform the design of YM€™s planned Phase II trial for the U.S., for which an IND will be filed shortly, as well as the design of the eventual Phase III trial.


Tesmilifene:

In January 2007, the Data Safety Monitoring Board (DSMB) overseeing the €˜DEC€™ Phase III pivotal trial of tesmilifene in combination with epirubicin and cyclophosphamide for the treatment of rapidly progressing metastatic breast cancer completed the third planned interim analysis. Evaluating data that included 351 patient events, the DSMB advised the Company that, although there were no safety concerns and that the trial was well conducted, it was highly unlikely to meet its primary efficacy endpoint. Accordingly, YM terminated the trial.


Financial Results (CDN dollars)

Total revenue for the quarter ended March 31, 2007 was $2.0 million compared to $0.7 million for the same period last year. Total revenue for the first nine months of the 2007 fiscal year was $5.7 million compared to $1.5 million for the first nine months of the corresponding period last fiscal year. Revenue increased as a result of two out-licensing agreements entered into since March 31, 2006 and from increased interest income due to higher cash balances. The larger out-licensing agreement, signed with Daiichi Pharmaceutical Co., Ltd. in July 2006, for the commercial rights to nimotuzumab for the Japanese market included a non-refundable up-front payment from Daiichi to the Company of $14.6 million, net of withholding tax. The gross amount of this initial license fee has been recorded as deferred revenue and is being recognized over the estimated period of collaboration required.

Total operating expenditures for the quarter ended March 31, 2007 were $10.9 million, which included a $1.8 million non-cash write-off of an intangible asset, compared to $6.6 million for the same period last year. Total expenditures for the first nine months of the 2007 fiscal year were $31.0 million compared to $18.8 million for the first nine months of the corresponding period last year. General and administrative expenses for the third quarter were $1.7 million and for the first nine months were $5.6 million compared with $1.9 million and $4.6 million respectively for the same periods in the prior year. Licensing and product development expenses for the third quarter were $7.3 million and for the first nine months were $23.6 million compared to $4.7 million and $14.3 million respectively for the same periods in the prior year.

The increases resulted primarily from increased salaries and bonuses due to the addition of employees since May 2006. Also during the quarter, the Company incurred expenses with respect to the termination of several executives in February 2007. Total amortization with respect to intangible assets totaled $0.4 million for the quarter compared to $0.3 million for the same period in the prior year. Year-to-date intangible amortization charges ended March 31, 2007 totaled $1.7 million compared to $0.8 million for the same period in fiscal 2006.

Costs associated with development activities for nimotuzumab decreased by $0.8 million for the quarter ended March 31, 2007 compared with the third quarter of fiscal 2006. For the nine months ended March 31, 2007, costs increased by $2.4 million over the corresponding period in fiscal 2006 as a result of additional pre-clinical and clinical studies being conducted in fiscal 2007 compared to fiscal 2006.

Costs associated with development activities for AeroLEF„ increased by $0.3 million for the quarter ended and by $0.6 million for the nine months ended March 31, 2007 over the respective corresponding periods in fiscal 2006 due to additional costs associated with the phase IIb clinical trial.

Costs related to development activities for tesmilifene for the three month period ended March 31, 2007 increased to $2.9 million compared to $2.7 million for the comparable period last year. Current costs for the quarter mainly pertained to closing down the Phase III trial of tesmilifene and the settlement of holdback amounts from the original contract of the trial. Year-to-date costs decreased to $6.8 million compared to $8.7 million for the same period in the prior year, as a result of reduced costs associated with the Phase III clinical trial.

On February 1, 2007, the Company recorded an impairment for the unamortized portion of the workforce intangible asset that was acquired in the Eximias acquisition on May 9, 2006. After the termination of the Phase III trial of tesmilifene, management re-evaluated the workforce intangible and determined it to be impaired based on an analysis of the carrying value and projected future cash flows of the asset. This resulted in a non-cash charge of $1.8 million, the net book value of the asset on the day of impairment.

Net loss for the fiscal third quarter of 2007 was $8.9 million and for the year to date was $27.0 million compared to $5.8 million and $17.2 million respectively for the same periods last year.

As at March 31, 2007 the Company had cash, cash equivalents and short-term deposits totaling $81.2 million and payables and accrued liabilities totaling $3.7 million compared to $86.0 million and $2.1 million at December 31, 2006 and $88.3 million and $3.7 million at June 30, 2006 respectively.

As at March 31, 2007 the Company had 55,835,356 common shares outstanding. In addition, the Company had 2,380,953 common shares held in escrow for contingent additional payment related to the acquisition of DELEX Therapeutics Inc.; 8,972,277 warrants and 4,442,455 options outstanding.

Da sind viele Anleger sehr optimitisch, tief war bei 1.18EUR, aber ohne mich (Kauflimitte war bei 1.15), dem Kurs springt der Springer nicht hinterher. Heute last 1.43EUR über 20% mehr. Das Wettrennen geht also ohne mich weiter. Beobachten und berichten tue ich aber trotzdem, bleibt ja auch weiterhin spannend.

Wieder mal News zu YMI, lange war's ruhig, der Kurs läuft im Band 1.3EUR...1.4EUR, alle warten, ruhe vor dem Sturm? Jedenfalls scheint der Boden bei ca. 1.3EUR gefunden zu sein, jetzt hängst an den weiteren Studienergebnissen. Vielleicht noch interessant zu erwähnen, wie die Statistik und die Erfolgsquote zusammenhängt mit Biotech:

Phase I: Erfolgschance ca. 5%-15%, Phase II 15%-20%, Phase III 50%-80%, Zulasungsverfahren 80%-90%. Einige Postings zuvor lässt sich nachlesen, in welcher Phase YMI potenzielle Produkte hat. Zeithorizont pro Phase 1..3 Jahre, Zulassungen sind immer in einem unsicherer Zeitfenster (USA z.B. FDA).

Bin zur Zeit nicht investiert, verfolge am Rande wann's immer zeitlich reicht. Titel nach wie vor interessant, da jetzt die Scheinchen fast nicht mehr unter 1.3EUR abgegeben werden. Neue Ergebnisse sollten bald kommen (Juli)


Quelle Nasdaq.com:

YM BioSciences Gets FDA Clearance For IND Application For AeroLEF

(RTTNews) - On Wednesday, YM BioSciences Inc. (YMI, YM.TO) announced that it has received U.S. Food and Drug Administration clearance for its Investigational New Drug or IND application for AeroLEF.

AeroLEF is a unique, inhaled-delivery composition of free and liposome-encapsulated fentanyl in development for the treatment of moderate to severe pain, including cancer pain.

YM recently reported that AeroLEF met its primary endpoint in a 99 patient, randomized, placebo-controlled, multi-center Phase IIb trial (DLXLEF-AP4) in opioid-naive patients with post-operative pain following orthopedic surgery.