YM Bio. Com Shs Share Discussion Threads

[rambutan2] 18/9/2005 14:27

following a request, here's a summary of its main stuff and where ymba is up to with it (courtesy of randychub 31/08)...

The phase 3 tesmilifene trial will get a early look in the middle of next year. The first phase 3 trial showed a 143% increase in survival for this group of patients. This is why I invested here.

The other main drug is theracim. A knock off of imclones drug erbitux, without the rash. We have not seen enough completed trial data to know the efficacy of this drug yet but we have already seen H&N data similiar to erbitux. It is already approved in china for h&n cancer. This drug has also shown efficacy in pontine gliomas, a brain cancer that is very hard to treat. If this drug continues to show efficacy it will also greatly improve the value of this company. We are waiting for the emea to give the go ahead on 2 phase 3 brain cancer trials and a phase 3 H&N cancer trial. We are also expecting pancreatic cancer data soon.

Check out this link and if you have any questions when your done, fire away.

Randy




and a reminder re what % royalties ymba pay on these in-licensed drugs...

Tesmilifene royalties - we pay 4.16 percent.

YM owns all rights in US and EU.

Theracim - Oncoscience pays YM 30% (estimate)

YM owns all rights in the US

YM get royalties from cancervax for a egf vaccine.
(and dont forget partners who will pay royalties and help develop these drug in other indications lowering the development costs for ymba.)

[rambutan2] 30/8/2005 22:44

loads of news expected over next few months...
MISSISSAUGA, ON, Aug. 30 /CNW/ - YM BioSciences Inc. (AMEX:YMI, TSX:YM,

AIM:YMBA), the cancer product development company, today announced that its

subsidiary, DELEX Therapeutics Inc., has received permission from Heath Canada

to initiate a randomized Phase IIb study with AeroLEF(TM), its unique

formulation of the opioid, fentanyl, for the treatment of moderate to severe

acute pain.

'YM has delivered on its first milestone in its clinical development

program for AeroLEF(TM)', said David Allan, Chairman and CEO of YM

BioSciences. 'We expect that this trial will continue to demonstrate the

important difference that DELEX's particular approach makes to patients with

its pulmonary delivery of opioids when compared to all the other entrants into

this large market.'

[rambutan2] 01/8/2005 20:09

beginning to get a fan base in germany (where some of trials being held)...

BUSINESS WEEK MAGAZINE
Top 25 best Micro Cap purchase candidates -- -
Expand table with all criteria values

Symbol / Company Name Group Options Trend Price

DRAX DRAXIS HEALTH INC .DRE 4.760
NEOG NEOGEN CORP .DBI 15.100
BNT BENTLEY PHARMACEUTICALS INC .DET 10.920
XGEN XENOGEN CORP .DBI 4.240
CPD CARACO PHARMACEUTICAL LABS L .DRU 9.040
UG UNITED GUARDIAN INC .DRU 8.090
TRMS TRIMERIS INC .DBI Options 12.950
EMBX EMBREX INC .DBI 11.140
MCU MEDICURE INC .DRE 0.880
YMI YM BIOSCIENCES INC .DRE 3.050
KNDL KENDLE INTL INC .DBI 16.710
ORCH ORCHID BIOSCIENCES INC COM PAR $0.01 .DBI 10.860
GNTA GENTA INC COM NEW .DBI 1.260
INKP INKINE PHARMACEUTICAL INC .DRE 3.340
CURE CURATIVE HEALTH SVCS INC NEW .DRE Options 2.490
HITK HI-TECH PHARMACAL INC .DRU 27.970
INO INOVIO BIOMEDICAL CORP .DBI 3.200
VITX V I TECHNOLOGIES INC COM NEW .DBI 6.680
BSMD BIOSPHERE MED INC .DBI 5.730
CRTX CRITICAL THERAPEUTICS INC .DRE 7.000
APPA AP PHARMA INC .DBI 1.800
HBIO HARVARD BIOSCIENCE INC .DRE 3.280
QGLY QUIGLEY CORP COM NEW .DRU 8.950
NAII NATURAL ALTERNATIVES INTL COM NEW .DRU 8.020
PPCO PENWEST PHARMACEUTICALS CO .DRE Options 12.230

prosearch.businessweek.com/businessweek/SECTOR_BEST_DRUGS.html?CAP=1

and
hxxp://www.medadnews.com/News/Index.cfm?articleid=259645

"Opinion leaders are optimistic that, as with many tumor types, targeted therapy holds the greatest hope for glioblastoma patients. Epidermal growth factor receptor (EGFR) inhibition appears to be a lucrative target with YM Biosciences/Center of Molecular Immunology/Oncoscience's nimotuzumab (TheraCIM h-R3) being the first EGFR-directed monoclonal antibody to reach late-stage trials for glioma. Phase II trial results are promising and a Phase III study is planned. "

and in india re theracim (licenced from cuba, not us)...
Mazumdar-Shaw said Biocon had an "exciting pipeline" of two research products --Biomab, a novel drug for head and neck cancer and its oral insulin programme.

Biomab is in the final stages of Phase IIb clinical trials and the company expects to file for fast track approval in India by the yearend, she said.
It is expected to enter the Indian market by early next fiscal, Mazumdar-Shaw said. "The prospects are that we will get early regulatory approval."

Biomab (h-R3) is engineered to attack the specific Epidermal Growth Factor Receptor responsible for the origin and growth of cancer cells. Bio-mab would spearhead the company's foray into proprietary products for cancer therapy.

The company had established a mammalian cell culture facility for the production of MAbs (Monoclonal Antibodies) and the plant is expected to be commissioned this year to coincide with the completion of clinical evaluation in h-R3.

Based on the success of the project, Biocon would enter into RandD collaborations for the development of other cancer drugs, the company said.
According to estimates, 80,000 cases of head and neck cancer are diagnosed in the country every year, she said, emphasising that it offered a "huge potential."

[rambutan2] 15/7/2005 14:13

weve hit a new high on aim (due to silly spread), although bit below high on amex and tsx.

as i said, its starting to get more coverage in states...

14/07/05
10:15 YMI YM BioSciences initiated with a Buy at Ragen MacKenzie; tgt $6 (3.12 +0.05)

-Update- Ragen MacKenzie initiates YMI with a Buy and $6 tgt. Firm notes that Tesmilifene is currently in a Phase 3 clinical trial for the treatment of metastatic breast cancer, while nimotuzumab is awaiting clinical trial design indications from the FDA and EMEA for its Phase 3 trial. They say that if the co's products are found to be efficacious and relatively safe, the market for YMI's products could be quite large. They project YMI could be worth $6, leading up to FDA approval of tesmilifene.

[rambutan2] 14/7/2005 11:33

still trading nicely in states...

Re: I think the move is related to the
by: io_io 07/13/05 08:26 pm
Msg: 1002 of 1017

Plus I would guess that of this list, only #5 is a q4 event at the latest, all the others are probably q3, at least based upon what we have been guided by the company in it's past announcements.

The only date we could nail within 7-10 days is enrollment of phase 3 tesmilifene trial - it will be very close to 31st August, maybe sooner.


1. Start of Phase 3 pontine glioma trial
2. Start of Phase 3 H&N trial
3. Start of Phase 3 GBM trial
4. Start of Tesmilifene/Taxotere trial
5. Update of single patient pontine glioma trial
6. Update on Pancreatic cancer trial
7. Complete enrollment of phase 3 tesmilifene trial.

[rambutan2] 30/6/2005 10:51

from advfn research, the latest canaccord note, some good detail and slightly raised 12 month price target of 230p...


and one from end of last year from griffin sec which worth a look, their then target was $5.40...

[rambutan2] 04/6/2005 14:53

they forgot to rns this...

YM BioSciences achieves primary objective with Norelin(TM) study
Wednesday May 25, 7:00 am ET

MISSISSAUGA, ON, May 25 /PRNewswire-FirstCall/ - YM BioSciences Inc. (AMEX:YMI, TSX:YM, AIM:YMBA), the cancer product development company, announced today that Norelin(TM), its anti-cancer vaccine targeting the gonadotropin releasing hormone (GnRH), has successfully completed a proof of concept study in men with hormone dependent prostate cancer (HDPC). The majority of patients with HDPC treated with Norelin(TM) developed antibodies to GnRH, demonstrating the development of an immunological response, which was the primary objective of the trial.

[rambutan2] 20/5/2005 12:33

and more v good news...

YM BioSciences and CIMAB achieve clinical milestone

- Data for TheraCIM h-R3 in High Grade Malignant Glioma presented at

ASCO 2005 -

- Clinical benefit of EGF-R monoclonal antibody demonstrated with absence

of rash, anaphylaxis or diarrhea -


MISSISSAUGA, ON, May 19 /CNW/ - YM BioSciences Inc. (AMEX:YMI, TSX:YM,

AIM:YMBA), the cancer product development company, today announced data from a

presentation at the American Society of Clinical Oncology 2005 Annual Meeting

for an open label Phase I/II trial in high grade malignant glioma tumors in an

adult population utilizing the EGF receptor humanized monoclonal antibody h-R3

(nimotuzumab) as a combination therapy.

'TheraCIM continues to demonstrate clinical benefit in a broadening

number of cancer indications. The data from this trial are supportive of the

application by our partner Oncoscience AG for approval to initiate a Phase III

pivotal trial in Europe. These compelling results follow our release of data

in February 2005 demonstrating an overall response rate of 35.3% observed in a

monotherapy trial of TheraCIM h-R3 ('Theraloc' in Europe) in pediatric glioma

where the children had failed all other courses of treatment,' said Mr.

David Allan, Chairman of YM BioSciences.

'We are impressed by the continuing absence of acneiform rash, which is

reported in the literature as being physically and emotionally debilitating

and suffered by many patients treated with the other products being developed

for inhibition of HER1/EGFR. We also continue to see no evidence of

anaphylaxis or severe diarrhea similarly reported in other trials,' added

Dr. Normando Iznaga, Global Project Manager for TheraCIM h-R3 at CIMYM Inc.

The study was conducted in Cuba by CIMAB S.A., YM's partner in its

subsidiary CIMYM Inc. CIMAB S.A. is a company representing the Center of

Molecular Immunology, the originator of TheraCIM h-R3 at CIMYM Inc.

[rambutan2] 19/5/2005 12:51

must-read research update...

[rambutan2] 14/5/2005 19:35

this is 110p to buy in states, 116p to buy in canada and 130p to buy on aim!

[rambutan2] 14/5/2005 19:28

Stanford: Buy Target $6.00 (us$ that is)

Initiates coverage. Firm believes that investors are not fully aware of potential of Tesmilifene and TheraCIM offers several advantages over Erbitux and ABX-EGF per Briefing.com on 5/05.

couple of worth noting posts from states...

by: RANDYCHUB (39/M/Wisconsin)
Long-Term Sentiment:
Strong Buy 05/13/05 11:59 am
Msg: 816 of 829

I disagree about the burn rate. We have the cash at the present rate to get tesmilifene thru this phase 3 trial which is key.

We also may get theracim brain trials thru phase 3 with oncoscience.

by: reid_4
Long-Term Sentiment: Strong Buy 05/13/05 12:41 pm
Msg: 818 of 829

Randy -- actually it's a close call. The company says that its cash will be sufficient through fiscal 06, which would mean the end of second quarter 06 (June 30).

My opinion is that the company will not want to put itself in the position of possibly running out of money before getting positive results from the Tesmilifene or TheraCim trials.

I'd be shocked if they didn't do one more offering before the end of this year or soon thereafter.

That is the only reason I can see why the stock price is so depressed. Right now, were talking about a market cap of $80 million for two outstanding very late stage cancer drugs and a third pain drug with substantial promise.

TheraCim looks like a no-brainer for approval. The results have been consistently strong, and it's already approved in several countries. Tesmilifene has to repeat what it did with resounding statistical significance in the last phase 3. There's a measure of doubt there, but the chances to me look pretty good that it will. Both of these drugs have blockbuster potential and can be on the market within two years.

Someone may want to steal some more shares at absurdly low levels before this stock begins its inevitable march up.

[rambutan2] 13/5/2005 13:32

and from above...

Highlights:

- Expanded the development program for tesmilifene into gastric cancer

and into Asia, by partnering with Shin Poong (Seoul, Korea).

- Completed the protocol for a tesmilifene trial in metastatic breast

cancer in combination with Taxotere(R) and received approval to

initiate this trial.

- Reported that a Phase II trial in Europe in children with brain

cancer (glioma) utilizing TheraCIM hR3 as a monotherapy achieved an

overall response rate of 35.3%.

- An IND was issued by the FDA for a single-patient clinician

sponsored trial using TheraCIM hR3, a significant advancement in

YM's U.S. regulatory strategy for the drug.

- The licensee for TheraCIM hR3 in China received approval for the

drug in that country for the treatment of nasopharyngeal carcinomas

in combination with radiotherapy. TheraCIM hR3 has also been

approved in Argentina, Colombiaand Cuba for head and neck tumors in

combination with radiotherapy. Although YM's licensing rights for

TheraCIM hR3 do not extend into these territories, this is important

validation for this drug both for its therapeutic value and its

regulatory development.

- Acquired DELEX Therapeutics Inc., a private clinical stage

biotechnology company developing AeroLEF(TM), a unique inhalation

delivered formulation of the established drug, fentanyl, to treat

cancer pain.



Milestone targets for balance of calendar 2005:

- Tesmilifene: dose first patient in Taxotere(R) Phase II trial

(patient screening underway)

- Tesmilifene: complete recruitment of Phase III metastatic breast

cancer in Q3

- Tesmilifene: complete recruitment of Taxotere(R) Phase II in

metastatic breast cancer

- TheraCIM/Theraloc: initiate randomized Phase III trial in glioma

- TheraCIM: initiate pharmacodynamic study

- AeroLEF(TM): initiate Phase IIb pain trial

- Norelin(TM): disclose data from Phase II extension trial

[rambutan2] 13/5/2005 13:30

third quarter results out...

MISSISSAUGA, ON, May 12 /CNW/ - YM BioSciences Inc. (AMEX:YMI, TSX:YM,

AIM:YMBA), the cancer product development company with an advanced-stage

portfolio, today reported operational and financial results for the third

quarter of fiscal 2005, ended March 31, 2005.

'YM has delivered another successful quarter. TheraCIM hR3 yielded

positive results from a Phase II trial in children with brain cancer who had

failed all other treatments. Furthermore, YM has been advised that the

licensee of TheraCIM hR3 for China obtained approval for the drug in that

country. For the pivotal Phase III trial of our lead drug, tesmilifene,

recruitment approached 50% of the targeted 700 patients at the end of the

quarter and this milestone has now been surpassed,' said David Allan, Chairman

and CEO of YM BioSciences. 'Subsequent to the end of the quarter, we broadened

our product portfolio significantly with the acquisition of DELEX, adding an

additional late-stage product to our pipeline. We are poised to enter the new

fiscal year with a broad, diverse pipeline focused on the entire cancer market

that should generate a substantial volume of newsflow over the coming months.'

[rambutan2] 03/5/2005 14:14

completion and clarification...
MISSISSAUGA, ON, May 3 /CNW/ - YM BioSciences Inc. (AMEX:YMI, TSX:YM,

AIM:YMBA), the cancer product development company, today announced it has

completed the purchase of DELEX Therapeutics Inc. (Mississauga, Canada), a

private clinical stage biotechnology company developing inhalation delivered

fentanyl products to treat cancer pain. DELEX's lead product is AeroLEF(TM), a

proprietary technology for the treatment of acute and breakthrough pain that

has completed preliminary efficacy trials and will undergo further Phase II

efficacy trials in 2005.

'This acquisition significantly enhances our portfolio of late-stage

cancer-focused products. By concentrating on the entire cancer market and

diversifying our pipeline across technologies and target populations, we are

providing our shareholders with numerous opportunities to realize value while

mitigating risk,' said David Allan, Chairman and CEO of YM BioSciences. 'The

technology from DELEX targets the approximately $3 billion market for

fentanyl-based products that is driven by the total number of patients

suffering from cancer pain, which in the U.S. alone exceeds the patient

populations for the 50 most common cancers combined. AeroLEF(TM) is designed

to deliver both rapid onset of relief as well as sustained relief, an advanced

approach to treating pain that uniquely addresses the broader fentanyl market

rather than a single subset.'

Through this acquisition, DELEX becomes a wholly-owned subsidiary of

YM BioSciences. In consideration for their shares and the accompanying working

capital in DELEX, YM BioSciences issued to the DELEX shareholders 1,587,302

common shares upon closing of the transaction. As previously disclosed, YM may

issue up to 1,825,396 additional common shares in escrow that will be released

in tranches on specific dates and up to 2,777,779 common shares in escrow that

will be released only if specific milestones are achieved. On receipt of U.S.

regulatory approval, if any, for AeroLEF(TM) or any product using DELEX's

technology, YM BioSciences will make an additional payment to the DELEX

shareholders of $4.75 million in cash and/or common shares.

[rambutan2] 15/4/2005 17:52

looks quite a canny purchase...
MISSISSAUGA, ON, April 13 /CNW/ - YM BioSciences Inc. (AMEX:YMI, TSX:YM,

AIM:YMBA), the cancer product development company, today announced it has

entered into a binding agreement, subject to the fulfillment of certain

preconditions, in respect of the purchase of DELEX Therapeutics Inc.

(Mississauga, Canada), a private clinical stage biotechnology company

developing inhalation delivered fentanyl products to treat cancer pain,

pursuant to which DELEX will become a wholly-owned subsidiary of

YM BioSciences.

DELEX is advancing AeroLEF(TM), a proprietary technology for the

treatment of acute and breakthrough pain, conditions that are common in cancer

patients and underserved by existing technology. AeroLEF(TM) is an inhalation

delivery system that delivers both free and liposomal encapsulated fentanyl,

an opioid drug widely prescribed to treat cancer pain. This product has

completed a Phase IIa trial with positive results and further efficacy trials

in acute and cancer pain are planned for initiation in 2005.

'This acquisition is consistent with our model of acquiring products

suitable for clinical development and then applying our regulatory, clinical

and capital markets expertise to advance these products towards

commercialization rapidly and efficiently,' said David Allan, Chairman and CEO

of YM BioSciences. 'DELEX's late-stage product is an excellent fit within our

cancer-focused portfolio, targeting the substantial population of cancer

patients who experience severe pain. DELEX also comes with suitable resources

to advance this product through the next proposed Phase IIb pain trial without

requiring any additional cash investment by YM.'

'AeroLEF(TM) has the prospect of being a best-in-class product in the

multi-billion dollar pain market,' said Diana Pliura, CEO of DELEX.

'AeroLEF(TM) is the only product designed to provide real-time patient

optimized pain relief during dosing and, through DELEX's proprietary ROSE-DS

formulation technology, that can produce rapid onset of relief combined with

extended relief - significant differentiators to competitive products in

development.'

On closing of the transaction, anticipated to occur in early May,

YM BioSciences will issue to the DELEX shareholders in consideration for their

shares and the accompanying working capital in DELEX 1,587,302 common shares.

In addition, YM will issue up to 4,603,175 common shares in escrow for the

benefit of the DELEX shareholders. These escrowed shares will be released in

tranches of approximately 456,349 common shares six, 12, 18 and 24 months

following closing. The remaining 2,777,779 escrowed shares will be released

from escrow upon achievement of specific milestones including the receipt of

an INDfor the planned Phase IIb trial, the conclusion of a strategic

partnership for further development and commercialization of the product, and

upon the initiation of Phase III trials. In addition, on receipt of U.S.

regulatory approval, if any, for AeroLEF(TM) or any product using DELEX's

technology, YM BioSciences will make an additional payment to the DELEX

shareholders of $4.75 million in cash or common shares or a combination of

both.

The principal shareholders of DELEX, in addition to its founders and

management, are the New Generation Biotech (Equity) Fund Inc., a fund managed

by Genesys Capital Partners, BDC Venture Capital and the Eastern Technology

Seed Investment Fund Limited Partnership. Orion Securities and McFarlane

Gordon Inc. advised on the transaction.



Notice of Conference Call



YM will host a conference call to discuss this transaction on Monday,

April 18th, 2005 at 12:00pm EST. The call may be accessed by calling

+ 1-416-640-4127 (from Europe) or 1-800-814-3911 (in North America). A live

operator will be available to assist you. An archive of the conference call

will be available until April 25th and can be accessed by dialing

+ 1-416-640-1917 (from Europe) or 1-877-289-8525 (in North America) and

utilizing the participant code 21121537. The conference call will also be

audio cast live and archived for 90 days at

[rambutan2] 07/4/2005 13:51

not a good day for our US partner yesterday...
Cancervax (NASDAQ: CNVX) plummeted 49.36% to $3.18 on volume of 1,382,625 after the company said it would halt a Phase III trial of its Canvaxin treatment for Stage IV melanoma. The move comes on the heel of a determination by the Data and Safety Monitoring Board that the trial's data may not provide significant evidence of survivor benefit.

[rambutan2] 06/4/2005 17:41

quarter four 04 fact sheet...