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Post# of 251796
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io_io

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Alias Born 01/17/2005

io_io

Re: io_io post# 12593

Thursday, 07/14/2005 7:15:21 PM

Thursday, July 14, 2005 7:15:21 PM

Post# of 251796
YMI - Updated RMF:

(Dew, is there a way I can "point" the RMF to this post ?)



YMI – Read-Me-First




PROFILE:

YMI Fact Sheet: http://www.ymbiosciences.com/downloads/2004%20-%20Fall%20YM%20Fact%20Sheet.pdf

Business Model: http://www.ymbiosciences.com/main.cfm?docID=28



PRESENTATIONS / INTERVIEWS:

1. Rodman/Renshaw Webcast and 44-slide presentation, 5/2005
www.wsw.com/webcast/rrshq5/ym/

2. Twist Interview excerpt with David Allan, CEO 1/10/2005
http://archive.twst.com/notes/articles/zav609.html

"Tesmilifene acts by potentiating all known current chemotherapies. On its own it is somewhat cytotoxic, but its real effect is enhancing the activity of other cytotoxic drugs. In the metastatic setting, very little has happened in terms of increasing survival of patients with recurrent or metastatic disease in the last 50 years. In metastatic breast cancer, the only evident increase in survival in that period of time was demonstrated by Herceptin, which produces about a 24% increase in survival and works in about a third of the women with metastatic breast cancer because of the pre-requisite to over express the Her-2 gene in order for Herceptin to be effective. Tesmilifene, in its first Phase III trial, demonstrated a 140% increase in overall survival time in women with metastatic breast cancer ' significantly more potent apparently than Herceptin ' in a specific patient population in that trial. Under the special protocol assessment in the current clinical trial, the FDA requires YM to demonstrate a 33% benefit in order to register the drug in the same specific patient population as the first trial. So there is a great deal hanging on this trial, but a considerable amount of evidence the trial is likely to have a positive outcome. The strategies for tesmilifene are, first of all, to get the registration in the current indications and then, probably, to expand the drug into hormone-refractory prostate cancer where we already have significant clinical data from a completed US trial and then eventually into lung cancer, lymphoma and, ultimately, into the adjuvant setting in breast cancer. So the drug, if it is successful in this trial, could very well turn out to be a drug of considerable importance in the cancer landscape."



3. Feb 08 2005 Bioscience World interview with David Allan:
http://www.bioscienceworld.ca/view.html?id=1536

“The instant we license a drug in we start thinking about who might want to buy it from us,” says YM chairman and CEO David Allan. YM understands that sometimes plans unexpectedly change, and therefore, approaches commercialization on a drug-to-drug basis, Allan says. Typically, the company looks to have out-partnering deals by the Phase II stage of clinical development. “The reason that tesmilifene and TheraCIM are still, by great good fortune, in our portfolio and not partnered, is just dumb luck,” he says.




AGM:

AGM & Special Meeting, Dec 04 (audio): http://www.startcast.com/shows/8/A0129/

AGM & Special Meeting, Dec 04 (presentation):
http://www.ymbiosciences.com/downloads/AGMpresentation.pdf#search='tesmilifene%20phase%20II%20breast....



DRUG CANDIDATES/PIPE-LINE:

Tesmilifene (& Enrollment Status): http://www.ymbiosciences.com/main.cfm?docID=17

Theracim: http://www.ymbiosciences.com/main.cfm?docID=18
notes:
YMI holds the rights to TheraCIM through it's 80% owned subsidiary CIMYM INC. in the USA, CANADA, JAPAN, TAIWAN, SINGAPORE, THAILAND, PHILLIPINES, MALAYSIA, INDONESIA, AUSTRALIA, NEW ZEALAND.
In Europe, YMI has partnered with Onco_Sciences of Germany and will receive milestone and royalty payments.
In China and India, the drug is licensed directly by CIMab (Cuba)

Norelin: http://www.ymbiosciences.com/main.cfm?docID=19



PIPE-LINE PROGRESS:


1. Tesmilifene


B.C. Market
http://www.combichemlab.com/website/files/News/Press_Releases/2004/July-2004/Frost-Sullivan-1.htm

”Chemopotentiators such as YM Bio Sciences' Tesmilifene (in phase III clinical trials) are set to revolutionize chemotherapy treatment regimens by boosting the cytotoxic effect on tumor cells, while protecting healthy cells.”

Tesmilifene – original licensing by YM:
http://www.highbeam.com/library/doc0.asp?docid=1G1:66919353&refid=ink_tptd_np&skeyword=&....

Tesmilifene – Phase II B.C. Publication (Paper):
http://www.jco.org/cgi/reprint/17/11/3431?ijkey=097d4e5c12df3d21131a27d97516bd843eecc87f

Tesmilifene – Phase III B.C. Publication: http://www.ymbiosciences.com/presspop.cfm?newsID=2541

Tesmilifene – Phase III B.C. Publication (Paper):
http://www.jco.org/cgi/reprint/22/2/269?maxtoshow=&HITS=10&hits=10&RESULTFORMAT=&ful....

Tesmilifene - Sequential Analysis in Pivotal Trial: http://www.ymbiosciences.com/presspop.cfm?newsID=2082

Tesmilifene SPA Approval: http://www.ymbiosciences.com/presspop.cfm?newsID=2388

Tesmilifene ASCO 2005 Publication:
http://biz.yahoo.com/prnews/050519/to029.html?.v=5

A total of 305 patients were enrolled in the MA.19 trial. Of the 191 patients in whom cancer metastasized or recurred within 36 months from original diagnosis to trial entry, patients in the arm combining doxorubicin with tesmilifene had a median survival of 29.7 months compared to 12.2 months for patients on doxorubicin alone, a 143% improvement in overall survival (p=0.0016). The patient population of 305 was divided into tertiles of patients who had a disease-free interval (DFI) of greater than 36 months, 6 to 36 months and less than 6 months. The DFI group greater than 36 months demonstrated no benefit from the additional tesmilifene while the combined groups of less than 36 months DFI demonstrated the significant 143% difference in this unplanned, post-hoc analysis.


2. Theracim


Theracim – Product of The Center of Molecular Immunology (Cuba):
http://www.cim.sld.cu/productos/productos_ing.asp?var=13

Theracim – Start of Ped Glioma Trial (Europe): http://www.ymbiosciences.com/presspop.cfm?newsID=2950

Theracim – Start of Metastatic Pancreatic Cancer Trial (Europe): http://www.ymbiosciences.com/presspop.cfm?newsID=3370

Theracim – Results of Head-Neck Ear/Nose Cancer Trial (China): http://www.ymbiosciences.com/presspop.cfm?newsID=3450

Theracim – Results of Two Phase I/II Head-Neck Cancer Trials (Cuba + Canada):
http://www.ymbiosciences.com/presspop.cfm?newsID=1548

Theracim – Results Ped Glioma Trial (Europe): http://www.ymbiosciences.com/presspop.cfm?newsID=3607

TheraCIM receives Orphan Drug designation from FDA:
http://www.ymbiosciences.com/presspop.cfm?newsID=3398

TheraCIM receives investigator sponsored IND (ped glioma) from FDA:
http://www.ymbiosciences.com/presspop.cfm?newsID=3672

Theracim – Results of Adult Glioma Trial (Cuba) -ASCO 2005: http://www.ymbiosciences.com/presspop.cfm?newsID=3927

Theracim – Possible Launch in India late 05: http://www.biocon.com/biocon_press_news_details.asp?Fileid=147


3. Norelin

Norelin – Results of “Phase IIa” Trial (Canada): http://www.ymbiosciences.com/presspop.cfm?newsID=3936


4. Delex

Delex – Acquisition News + CC:
http://www.ymbiosciences.com/presspop.cfm?newsID=3757

Aero-LF – Phase IIa Results:
http://www.delextherapeutics.com/news/phase_IIa_results.pdf

Delex CEO – TWST Interview:
http://www.delextherapeutics.com/downloads/TWST_Interview_Feb03.pdf


5. Partnerships/Collaborations (Europe excluded)

Tesmilifene – Gastric & Breast Cancer- (Korea):
http://www.ymbiosciences.com/presspop.cfm?newsID=3522

Theracim – NSCLC (Korea): http://www.ymbiosciences.com/presspop.cfm?newsID=4002

Royalty Deal with CNVX: http://www.ymbiosciences.com/main.cfm?docID=21



CASH POSITION:

13 May 2005 3rd QTR commentary from management (w/ cash burn thru 2006):
http://www.ymbiosciences.com/presspop.cfm?newsID=3887

As at March 31, 2005 the Company had cash and short-term deposits totaling $31,081,073 and current liabilities of $1,018,028 compared to $20,387,858 and $1,163,711 respectively at June 30, 2004. The Company anticipates that the current cash reserves will be sufficient to support its current development program through the end of the 2006 fiscal year.


ANALYSTS:

12/22/2004 Merriman notes and $8-$12 target
http://www.briefing.com/GeneralContent/Platinum/Active/ArticlePopup/ArticlePopup.aspx?SiteName=PopUp....

13:47 YMI YM BioSciences: Color on TheraCIM data - Merriman (2.61 +0.11)
Merriman notes that yesterday YMI announced preliminary results from a randomized phase II trial conducted by its licensor in Cuba, and says TheraCIM may be better than equivalent to Erbitux. Notably, there was no evidence of skin rash, which has been seen with all other EGF receptor-blocking agents and has previously been assumed to be inseparable from efficacy. While survival data will be needed in order to compare these impressive tumor response results with those of Erbitux radiation therapy in head and neck cancer, firm believes that increasing visibility of the co's valuable pipeline could catalyze gains in the stock over the next 12-18 months toward $8-$12, a valuation more closely in-line with peers.

13 May 2005 Stanford Research Note:
http://www.briefing.com/GeneralContent/Platinum/Active/ArticlePopup/ArticlePopup.aspx?SiteName=PopUp....

10:04 YMI YM BioSciences started with a Buy at Stanford; tgt $6 (2.15 -0.04)
Stanford initiates YMI with a Buy and $6 tgt, saying few biotech co's offer as rich a pipeline as YMI, let alone with a mkt cap of just ~$100 mln. Firm believes that investors are not fully aware of the potential of Tesmilifene, and they say TheraCIM offers several advantages over Erbitux and ABX-EGF, including no anaphylaxis.



ANTICIPATED TRIAL MILESTONES:


1. Start of Phase 3 pontine glioma trial (EMEA)…………..…….…..... q3 – ‘05

2. Start of Phase 3 H&N trial (EMEA)………………….....………….. q3 – ‘05
.
3. Start of Phase 3 GBM trial (EMEA)…… …………………………... q3 – ‘05

4. Complete enrollment of phase 3 Tesmilifene BC trial ………….…Aug 31st ‘05

5. File Theracim IND in Canada and “elsewhere” for NSCLC ….………q3 –‘05

6. Start of Phase II Tesmilifene/Taxotere trial in BC…………………….. q3 – ‘05

7. Update on phase II Metastatic Pancreatic Cancer trial……………..….. q3 – ‘05

8. Korean Partner - File Theracim IND for NSCLC …………………….…q3 –‘05

9. Korean Partner – initiate Tesmilifene trials in gastric cancer ………..…...q4 – ‘05

10. Korean Partner – initiate Tesmilifene trials in bridging study for BC……q4 – ‘05

11. Update of USA single patient pediatric pontine glioma trial……….….…q4 – ‘05

12. Aero-LF - file IND for Phase IIb trial in Acute Pain (also Cancer Pain) …q4 – ‘05

13. Norelin (cancer vaccine) …..phase IIb trial in HDPC…………………….…2006

14. First look (192 events) of phase 3 Tesmilifene BC trial ………….Apr 15th ‘06

15. First results of Phase II Tesmilifene/Taxotere trial in BC……………….mid – ‘06

16. Results of Phase 3 pontine glioma trial (EMEA)…………..…….…..... 2H ‘06

17. Results of Phase 3 H&N trial (EMEA)………………….....………….. 2H ‘06

18. Results of Phase 3 GBM trial (EMEA)…… …………………………... 2H ‘06


"....on the biotech battle-field, you need some élan...."

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