YM Bio. Com Shs Share Discussion Threads

[rambutan2] 05/4/2005 15:18

re my above post...

"The U.S. Food and Drug Administration has approved the use of YM BioSciences Inc.'s experimental TheraCIM drug in a clinician-sponsored study to treat a child with advanced brain cancer. The drug earlier achieved a 35-per-cent response rate in the second of three clinical trials conducted in Germany, allowing YM's European partner to proceed to pivotal testing. TheraCIM was developed in Cuba and has been precluded from clinical testing in the United States because of trade legislation with Cuba.

"This is a material step forward in potentially penetrating the U.S. market," said Dlouhy Merchant analyst Doug Loe. Mississauga-based YM said it is in the process of designing a study protocol that, if approved, would open a new trial to a large number of pediatric patients in the United States. TheraCIM is an antibody therapy, which has a mechanism of action that is similar to ImClone Systems Inc.'s Erbitux cancer drug.


and a reminder about the potential of this horribly neglected stock...

22-Dec-04
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.

[rambutan2] 16/3/2005 12:45

potentially very good/massive news...
YM BioSciences' TheraCIM receives investigator sponsored IND from FDA


- TheraCIM h-R3 (nimotuzumab) to treat child with brain cancer

under physician-led IND in USA


MISSISSAUGA, ON, March 16 /CNW/ - YM BioSciences Inc. (AMEX:YMI, TSX:YM,

AIM:YMBA) today announced that the FDA has approved the use of TheraCIM h-R3

as a monotherapy in the treatment of a child with advanced glioma under an

IND.

'Clearance to conduct a US-based investigation using TheraCIM h-R3 is

significant in the development path for this drug,' said David Allan, Chairman

and CEO of YM BioSciences. 'The clinical success that was achieved with

TheraCIM in Europe, Canada and Asia may now begin to be repeated in the US.

The IND will initially result in the treatment of a single patient, but we are

in the process of designing a protocol that, if approved, would open a new

trial to many pediatric patients in the United States. Our US strategy is

further supported by the FDA and European Regulatory Authority awarding Orphan

Drug status to TheraCIM for the treatment of glioma, received in 2004.'

For reasons of patient confidentiality neither the name of the

investigator nor the hospital will be disclosed. Further, the currently

limited supply of antibody renders it impossible for YM to support additional

investigator-led INDs at this time although quantities of the product are

being manufactured to enable YM to conduct a pivotal trial in pediatric

glioma.

The application to the FDA which resulted in the issuance of the IND to

the investigator was prompted by the release of data from a monotherapy trial

in pediatric glioma conducted at seven of the 52 hospitals that compose the

BFM (Berlin, Frankfurt and Munster) Group of hospitals in Germany. Data from

that trial, which was sponsored by Oncoscience AG, YM's partner in Europe,

were presented at the European High-Grade Glioma Meeting in February 2005.

(TheraCIM h-R3 is a monoclonal antibody licensed from CIMAB S.A., the

corporation representing the Center of Molecular Immunology in Havana.)



Tuesday February 15, 2005
Break-through needs & break-through companies in Cancer. Joining us tonight: Dr. Cal Stiller, Chair and CEO, Canadian Medical Discoveries Fund, Dr. Bob Phillips, CEO, Ontario Cancer Research Network, Sean Thompson, Director of Business Development at YM Biosciences, and Fred Francis, CEO, Resonant Medical

[rambutan2] 11/2/2005 12:16

YM BioSciences reports second quarter 2005 operational and

financial results



MISSISSAUGA, ON, Feb. 11 /CNW/ - YM BioSciences Inc. (AMEX:YMI, TSX:YM,

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

portfolio, today reported operational and financial results for the second

quarter of fiscal 2005, ended December 31, 2004.

'During the second quarter we significantly advanced both of the

late-stage anti-cancer drugs in our portfolio. For tesmilifene, enrollment for

our pivotal breast cancer trial continued as planned and we made significant

progress towards broadening the market potential for this drug through

partnerships and by targeting additional cancer indications,' said David

Allan, Chairman and CEO of YM BioSciences. 'For TheraCIM hR3, our humanized

monoclonal antibody that targets the EGF receptor, progress was made on

numerous fronts; we announced clinical efficacy results from two cancer trials

and trials in additional indications were initiated to broaden the market

potential for this drug as well.'



Second Quarter Highlights:

- Received regulatory approval to initiate a metastatic breast

cancer trial for tesmilifene in combination with Taxotere(R).

- Expanded the development program for tesmilifene into gastric

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

subsequent to the end of the quarter.

- Obtained Orphan Drug Status for TheraCIM hR3 for glioma by the

FDA for the U.S.

- Oncoscience AG, YM's European development partner, initiated a

monotherapy trial for TheraCIM/Theraloc in metastatic

pancreatic cancer.

- YM's licensor, CIMAB, reported a 90.6% complete response from a

randomized Phase II pivotal nasopharyngeal cancer trial using

TheraCIM h-R3 in combination with radiation.

- Achieved the clinical milestone in a Phase II trial using

TheraCIM/Theraloc in pediatric glioma, being conducted by

Oncoscience AG, permitting the initiation of a pivotal trial for

the drug in this population.



Anticipated milestones for the next quarter ending March 31, 2005:

- Tesmilifene: initiate trial with Taxotere(R)

- TheraCIM/Theraloc: initiate randomized trial in pediatric glioma

- TheraCIM/Theraloc: start staged pivotal trial in adult glioma

- TheraCIM: initiate pharmacodynamic study

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



Milestone targets for balance of calendar 2005:

- Tesmilifene: complete recruitment Phase III metastatic breast

cancer in Q3

- TheraCIM/Theraloc: complete recruitment Phase III glioma

- Tesmilifene: complete recruitment Phase II Taxotere in metastatic

breast cancer

- Expand product pipeline



Enrollment for the Company's tesmilifene breast cancer registration trial

accelerated significantly in the second quarter. At the end of the quarter, by

December 31st, 176 patients had been enrolled in the trial and as at February

10th, 240 patients had been enrolled from 16 countries in 50 of the 74

hospitals which are now open. YM continues to anticipate that enrollment of

the 700 patients in the trial will be completed in calendar third quarter of

2005 and include some 90 hospitals in 20 countries. A chart showing enrollment

and the numbers of sites active is available on YM BioSciences' website under

'Products', then 'Tesmilifene'. If the enrolment target is met and survival

results are similar to those from the initial tesmilifene Phase III trial,

then the Company should be in position to submit tesmilifene for FDA approval

in late calendar 2006 or early 2007 based on an interim analysis of data, as

previously agreed to with the FDA through a Special Protocol Assessment.



Financial Results

Total revenue for the quarter ended December 31, 2004 was $521,524

compared to $53,156 for the same period last year. Total revenue for the first

six months of the 2005 fiscal year was $989,998 compared to $104,763 for the

first six months of the corresponding period last year. Revenue consisted of

revenue generated from out-licensing agreements and interest revenue. Total

expenditures for the quarter ended December 31, 2004 were $3,379,021 compared

to $1,328,324 for the same period last year. Total expenditures for the first

six months of the 2005 fiscal year were $5,960,757 compared to $2,216,002 for

the first six months of the corresponding period last year. General and

Administrative expenses for the quarter were $1,259,259 and for the first six

months were $2,517,291 compared to $763,486 and $1,326,579 respectively for

the same periods in the prior year. These increases were due principally to

the expensing of employee stock options commencing on July 1, 2004 and the

cost of obtaining a listing on AMEX. YM started trading on AMEX on

October 1, 2004. Licensing and Product Development expenses were $2,119,762

for the second quarter and $3,443,466 for the first six months of the fiscal

year compared to $564,838 for the quarter and $889,423 for the first six

months of last year. Expenditure increases were due primarily to the ramp-up

of the Phase III clinical trial for tesmilifene that commenced in March 2004.

Net loss for the second quarter was $2,830,164 and for the year to date

was $5,098,863 compared to $1,275,168 and $2,111,240 respectively for the same

periods last year.

As at December 31, 2004 the Company had cash and short-term deposits

totaling $33,785,404 and current liabilities of $813,399 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

development program beyond the 2006 calendar year.



Notice of TheraCIM/Theraloc Results Conference Call

YM and Oncoscience AG will host a teleconference on data from their

Phase II trial in children with brain cancer (glioma) presented at the

European High-Grade Glioma Meeting immediately following that conference on

Monday, February 28, 2005 at 1:00pm EST and may be accessed by calling

[phone] (from Europe) or 1-800-565-5185 (in North America) and

utilizing the participant code 261890.

[rambutan2] 27/1/2005 20:17

canaccord update from last oct...

YM BioSciences (YM : TSX : C$2.46) - Buy - Target: C$5.00
Karl Keegan
Comment: YM BioSciences F2004 results: on track
YM's full-year 2004 results (published yesterday) were slightly ahead of
our forecasts. The company has yet to generate revenues, but costs were
controlled and the loss before taxes was C$7.2 million against our estimate
of C$8.4 million. More importantly, YM finished the year with C$20.4
million in the bank, and has since raised a further C$18.6 million after
expenses. This cash balance gives the company more than enough to finish
the on-going tesmilifene Phase 3 trial. The trial is recruiting on track,
and enrolment should complete in Q3 next year. In addition, YM announced
that it intends to take tesmilifene into trials with taxanes in metastatic
breast cancer, and the cash balance should be enough to fund that as well.
YM may also look to expand the label potential of the drug through future
trials in prostate and lung cancers, and non-Hodgkin's lymphoma. We value
YM BioSciences using our probability-weighted NPV model, which yields our
price target of C$5.00. In our view, this represents just the beginning for
YM, as further trials and indications for tesmilifene could substantially
add to the company's portfolio, and we have yet to include them in our
analyses.

update 30/01/05.
just noticed that in the research section of advfn theyve got cans june note. of course that was before the cancervax deal...

[rambutan2] 20/1/2005 16:14

worth noting that this is isa-ble, as an aim stock but with a full tsx and amex listing. for more details look at the most usefull iaim thread.

[timc] 23/12/2004 08:36

From Briefing.com commenting on the TheraCIM data:(Prices relate to US quote on YMI,)

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 .

Looks ridiculously cheap to me.

[rambutan2] 21/12/2004 13:48

Best news source is:

TSX - YM:
AMEX - YMI:

AIM - was YMBA but now delisted

ym has always been an undervalued oddity (see bottom links for some background and links to cuba) but in 2004 year things have really started to come to fruition as the drugs delivered, money came in and a big deal was signed with cancercax.


now could be a good time to buy into a very promising future. aim trades are zilch but tight spread on tsx and it is eligible for an isa (see iaim thread).

24/02/06: The current total float including unexercised options and warrants is 65.5 million. (but do check!)

their website:



overview of phase III cancer drug:

european partner for cuban cancer drug nimotuzumab:
and a view of the drug (then theracim, now called nimotuzumab, itself...
12/22/2004 Merriman notes and $8-$12 target

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.

also, indian cuban licencee (biomab = nimotuzumab ie Biomab®, an anti EGFR antibody is in the final stages of Phase IIb clinical trials and expects to file for fast track approval in India by the year end.)

lse rns:


US board:
Canadian board:
Enthusiasts board:
Conference calls:




from canaccord, july 04...
YM BioSciences (YM : TSX : C$3.50) - Buy - Target: C$5.20
Karl Keegan
Comment: YM's Cuban uncertainty removed?
The US Treasury has approved the licensure of two of YM's preclinical
compounds to CancerVax. Approval of the deal is important because the two
products originate in Cuba. This is the first time that Cuban originated
compounds have been licensed to a US company, and means that the products
can be sold in the US if successfully developed. The approval has wider
implications for YM, as it may mean that TheraCIM, a later stage antibody
in Phase 2 trials (which is also Cuban) may now be up for US licensure. We
believe that today's announcement removes a significant degree of
uncertainty for the stock, and it may open up the US market for more of the
pipeline. We maintain our BUY rating and C$5.20 target price.
NOTE: more recent canaccord notes are available on advfn research

bit of background...




The current cancer research at CIM is a joint project between the Cuban government and YM Biosciences Inc, an Ontario-based firm...