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"YM's business model, which unremittingly has been to diversify againstthe risk of clinical failure, has made it possible for us to mitigate in partjust such an unfortunate event earlier this year with the disappointingresults of the tesmilifene trial. With recruitment in nimotuzumab's firstPhase III trial having been completed; the initiation of two additional latestage trials this current quarter; with substantial international financialand human resources supporting a broad and aggressive development program fornimotuzumab; with AeroLEF(TM) having successfully completed its firstrandomized trial and being prepared for its Phase III trials, we have seen thebenefits of adhering to our corporate strategy. This strategy permits us tocontinue to take our late-stage products forward to surface their value," saidDavid Allan, Chairman and CEO of YM BioSciences. "Importantly, we start thecurrent fiscal year with more than US$65 million of cash available to supportour development programs."
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Nimotuzumab:
Nimotuzumab, a humanized monoclonal antibody that targets the epidermalgrowth factor receptor (EGFR), is currently in varying stages of developmentin a number of trials, including colorectal cancer, adult and pediatricglioma, non-small-cell lung cancer and pancreatic cancer. YM expects that therange of indications will continue to broaden in 2008 as the group'scooperative efforts expand. The drug is approved in a number of Latin Americancountries as well as China and India.
Daiichi Sankyo Co., Ltd. in Japan, Oncoscience AG in Europe, KuhnilPharmaceutical Co. in South Korea and Innogene Kalbiotech in Southeast Asiahave sub-licenses for nimotuzumab from CIMYM Inc., YM's majority-ownedsubsidiary. Cooperative trials have already been initiated with some ofCIMYM's licensees and YM anticipates that the licensees will increasinglyparticipate cooperatively to accelerate the rate of recruitment into trials ofcommon interest, reducing the costs of development for each participant,permitting rapid recruitment and shortening the time to completion of clinicaltrials.
AeroLEF(TM) is a unique, inhaled-delivery composition of free andliposome-encapsulated fentanyl in development for the treatment of moderate tosevere pain, including cancer pain. AeroLEF(TM) permits patients to identifyand select the appropriate dose in real-time for each pain episode to achieveboth rapid onset and extended duration of analgesia.
In January 2007, the Data Safety Monitoring Board (DSMB) overseeing the'DEC' Phase III pivotal trial of tesmilifene in combination with epirubicinand cyclophosphamide for the treatment of rapidly progressing metastaticbreast cancer completed the third planned interim analysis. Evaluating datathat included 351 patient events, the DSMB advised the Company that, althoughthere were no safety concerns and that the trial was well conducted, it washighly unlikely to meet its primary efficacy endpoint. YM terminated the trialand, with the exception of one further follow-up for confirmation expected incalendar Q4 2007 and the ongoing collaborative trial with Sanofi-Aventis inmetastatic breast cancer for which pharmacokinetic data should be available bycalendar year-end 2007, we intend to undertake no further clinicaldevelopment.
Financial Results (CDN dollars)
Total revenue for the fiscal year ended June 30, 2007 was $7.6 millioncompared to $2.5 million for the fiscal year ended June 30, 2006. Totalrevenue for the fourth quarter ended June 30, 2007 was $1.9 million comparedto $1.1 million for the same
