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LOL,Yes it would. YMI for $2.25, let's hope for that. Talking about price, will be a lot shorter in time.
Lord, if started talking about every thing I needed to make up on, we would be here forever!!!!
Crappy pps for me as well. Slightly up right now, hoping to be better tomorrow. Need to make up for holding ZGNX.
I have no idea chestnut, this has been a year of good news means crappy stock price for me, so I simply can't answer you.....let's hope for the best
The big question is. What will happen to pps tomorrow? Great news like this was pretty much expected, wasn't it?
News for 'YMI' - (YM BioSciences Reports Phase I/II Data for JAK Inhibitor CYT387 in Myelofibrosis at ASH 2012)
MISSISSAUGA, ON, Dec. 9, 2012, 2012 (Canada NewsWire via COMTEX) -- - 68%
transfusion independence response rate and 37% durable spleen response rate -
YM BioSciences Inc. (NYSE MKT: YMI, TSX: YM) today reported updated results from
the 166 patient Phase I/II study of its JAK1/JAK2 inhibitor, CYT387, for the
treatment of myelofibrosis. The results were presented this afternoon in an oral
session at the 54(th) Annual Meeting of the American Society of Hematology
underway in Atlanta, Georgia.
-- 68% durable 12-week transfusion independence response rate with
a maximal duration of response approaching three years and
ongoing.
-- The percentage of patients requiring transfusions decreased
substantially, from 44% at baseline to below 10% at week 40 of
treatment.
-- 37% durable spleen response per IWG-MRT* with a maximal
duration of response of nearly 2.5 years and ongoing.
-- The majority of subjects achieved a complete resolution or
marked improvement of common constitutional symptoms.
-- The majority of adverse events were Grade 1.
"These data continue to demonstrate that treatment with CYT387 results in
significant, durable responses in transfusion dependency, splenomegaly and
constitutional symptoms," said Dr. Nick Glover, President and CEO of YM
BioSciences. "The benefits CYT387 produces are highly encouraging for patients
with myelofibrosis and underscore the clinical potential of this drug."
*International Working Group for Myelofibrosis Research and Treatment
Phase I/II Core Study Results
Study Design and Subject Disposition The Core Study consisted of nine 28-day
treatment cycles where CYT387 was orally self-administered, primarily at dosages
of 150 mg once-daily (QD), 300 mg QD or 150 mg twice-daily (BID). Patients who
tolerated and benefited from the drug could continue to receive CYT387 for an
indefinite period beyond the Core Study in an Extension Study. The 300 mg QD
dosing regimen has been selected for use in the anticipated Phase III clinical
development program.
The median follow-up time for patients in the Core Study and Extension Study is
16.9 months (range: 0.8 - 34.2 months; ongoing). During the Core Study, 42
patients (25%) discontinued the study, eight for possibly or probably related
adverse events, for an overall retention rate of 75%.
Subject Baseline Characteristics The majority of the 166 patients enrolled
across the six study sites have primary myelofibrosis (63%); 22% have
post-polycythemia vera myelofibrosis and 15% have post-essential thrombocythemia
myelofibrosis. Other patient characteristics include:
-- DIPSS-Plus category: Int-1 - 10%; Int-2 - 62%; High - 28%
-- RBC (Red blood cell) transfusion-dependent: 44%
-- Palpable splenomegaly >10 cm: 79%
-- Patients who had received previous therapies, including other
JAK inhibitors (13%) and IMiDs (9%).
Transfusion Independence Response Of the 68 evaluable patients who were
transfusion dependent at baseline, 68% became transfusion independent for a
minimum of 12 weeks during the Core Study. The median duration of the
transfusion-free period has not yet been reached (range: 85 - 988 days,
ongoing). Of the transfusion dependent patients who did not achieve a full
transfusion independence response, 23% achieved at least a 50% reduction in
transfusion requirement in any 3-month period.
The percentage of patients requiring transfusions decreased substantially during
the study, from 44% at baseline to below 10% at week 40 of treatment.
Of the 28 evaluable patients who were transfusion dependent at baseline and
dosed at 300 mg QD, 75% have become transfusion independent for a minimum of 12
weeks.
Three additional patients achieved a 12-week transfusion independence response
during the Extension Study.
Spleen Response Of the 145 patients evaluable for spleen response by palpation,
37% achieved a response per IWG-MRT. The median duration of spleen response
reported was 744 days (range: 56 - 859 days, ongoing). Three additional subjects
achieved spleen response during the Extension Study.
During the Core Study, 50% of evaluable patients achieved more than a 50%
maximal decrease in spleen size from baseline, with 87% achieving more than a
25% maximal decrease.
Of the 51 patients who were evaluable for spleen response and dosed at 300 mg
QD, 39% achieved a response per IWG-MRT.
In the Core Study, 11 patients were evaluable for spleen response by MRI. The
response rate at six months was 45% by MRI (defined as a 35% decrease in spleen
volume) and the median splenic decrease from baseline at six months was -41% by
volume measured by MRI.
Constitutional Symptoms Response The majority of patients reporting
constitutional symptoms at baseline demonstrated a Complete Resolution or Marked
Improvement of their symptoms, including night sweats, pruritus and bone pain.
Safety Results CYT387 is well tolerated in myelofibrosis patients for dosing
periods currently up to three years and ongoing. The majority of adverse events
were Grade 1. Common reported adverse effects include thrombocytopenia;
transient, mild dizziness; mild peripheral neuropathy; and abnormalities in
liver/pancreas-related laboratory tests. Treatment-emergent anemia and
neutropenia were rarely observed.
Oral presentation and YM conference call: The results from the Phase I/II study
are being presented today at 5:15pm ET in an Oral Session at the 2012 Annual
Meeting of the American Society of Hematology in Atlanta, Georgia. YM will also
host a webcast meeting open to members of the investment community to discuss
the results. This event will be held from 6:30-7:30am ET on Monday, December
10(th) in the Imperial Salon Room A of the Atlanta Marriott Marquis, 265
Peachtree Center Ave. NE, Atlanta, Georgia. Access to the webcast will be
available from YM's website at www.ymbiosciences.com or at www.newswire.ca.
About CYT387: CYT387 is an inhibitor of the kinase enzymes JAK1 and JAK2, which
have been implicated in a family of hematological conditions known as
myeloproliferative neoplasms, including myelofibrosis, and as well in numerous
other disorders including indications in hematology, oncology and inflammatory
diseases. Myelofibrosis is a chronic debilitating disease in which a patient's
bone marrow is replaced by scar tissue and for which treatment options are
limited or unsatisfactory. Both the U.S. Food and Drug Administration (FDA) and
the European Commission have designated CYT387 an Orphan Drug for the treatment
of myelofibrosis.
AboutYM BioSciences YM BioSciences Inc. is a drug development company primarily
focused on advancing CYT387, an orally administered inhibitor of both the JAK1
and JAK2 kinases, which have been implicated in a number of hematological and
immune cell disorders including myeloproliferative neoplasms and inflammatory
diseases as well as certain cancers. Positive interim results have been reported
from a Phase I/II trial of CYT387 in 166 patients with myelofibrosis. YM's
portfolio also includes several preclinical programs underway with candidates
from its library of novel compounds identified through internal research
conducted at YM BioSciences Australia.
Why ymi has been seeing large block selling. Well heres the answer ...
I think it starts this week.......last week L2 showed some very large blocks going through. I believe entities are positioning for ASH now........
and this:
During the quarter we prepared for pivotal trials with CYT387 while continuing to explore potential opportunities to further develop and/or commercialize our drug with other companies.
Our Phase III readiness activities have progressed substantially on all fronts. Over the summer months we conducted productive discussions with regulatory authorities in the US and Europe which have affirmed the range of options available for the pivotal program for CYT387. On the manufacturing side, we recently established the bioequivalence of the tablet formulation of our drug and we have manufactured a supply of drug for pivotal trials. We have also completed preclinical toxicology studies required to proceed into these studies.
We look forward to reporting final results from the 166 patient Phase I/II study of CYT387 in myelofibrosis in December 2012. We were pleased to report that these results have been selected for presentation in an Oral Session at the 2012 Annual Meeting of the American Society of Hematology, reflecting the medical community’s strong interest in this data. In June 2012, all eligible patients completed the core part of this trial by receiving drug for nine months and many of these patients continue treatment with CYT387 in the ongoing extension trial, implying that CYT387 continues to provide benefits over longer periods of time.
We are steadily advancing towards the initiation of pivotal trials for CYT387, to be potentially initiated together with another company. We have robust data for CYT387, defined market and regulatory clarity for our lead indication, and sufficient resources to remain independent if desired. We thank you for continuing to share our enthusiasm for the potential of CYT387.
Sincerely,
Dr. Nick Glover
President and CEO
YM BioSciences Inc.
Date: November 9, 2012
I believe longs will finally see some positive movements in the next 30 days.........JMHO
GLTA
johan
7:11AM YM BioSciences beats by C$0.01; beats on revs (YMI) 1.62 : Reports net loss of C$0.05 vs (C$0.06) CIQ est; revs were flat YoY to C$0.3 mln vs C$0.2 mln CIQ est. As at September 30, 2012 the Company had cash and short-term deposits totaling C"25.5 mln and accounts payable and accrued liabilities totaling C$5.0 mln compared to C"32.5 mln and C$3.1 mln respectively as at June 30, 2012.
News for 'YMI' - (YM BioSciences Reports Operational and Financial Results for the First Quarter of Fiscal 2013)
MISSISSAUGA, ON, Nov. 9, 2012, 2012 (Canada NewsWire via COMTEX) -- YM
BioSciences Inc. (NYSE MKT: YMI, TSX: YM), a drug development company advancing
hematology and cancer related products, today reported operational and financial
results for the first quarter of fiscal 2013, ended September 30, 2012.
"During the quarter we prepared for pivotal trials with CYT387 while continuing
to explore potential opportunities to further develop and/or commercialize our
drug with other companies," said Dr. Nick Glover, President and CEO of YM
BioSciences. "We look forward to reporting final results from the 166 patient
Phase I/II study of CYT387 in myelofibrosis, which have been selected for
presentation in an Oral Session at the 2012 Annual Meeting of the American
Society of Hematology."
Summary Financial Results (CDN dollars) The interim consolidated financial
statements and comparative information for fiscal 2013 have been prepared in
accordance with International Financial Reporting Standards ("IFRS").
Revenue, generated from out-licensing remained constant for the first quarter of
fiscal 2013 ending September 30, 2012 at $0.3 million compared with $0.3 million
for the first quarter of fiscal 2012 ending September 30, 2011.
Net finance income was $0.4 million for the first quarter of fiscal 2013
compared to net finance income of $7.5 million for the first quarter of fiscal
2012. The changes in net finance income are primarily attributable to changes in
the fair value adjustment for USD warrants. Under IFRS, warrants denominated in
a different currency than the Company's functional currency must be classified
as a financial liability and measured at fair value, with changes reflected in
profit or loss. For the first quarter of fiscal 2013, the Company realized a
gain of $1.7 million on the revaluation of warrants, compared to a gain of $5.4
million for the first quarter of fiscal 2012.
Licensing and product development expenses were $7.2 million for the first
quarter of fiscal 2013 compared with $6.5 million for the first quarter of
fiscal 2012. Development expenses for CYT387 increased due to preparations for
the Phase III program in myelofibrosis, the extension of the Phase I/II clinical
trial in myelofibrosis, ongoing costs associated with the BID study,
pre-clinical development activities, and manufacturing of drug for these
programs.
General and administrative expenses were $2.0 million for the first quarter of
fiscal 2013 compared to $2.2 million for the first quarter of fiscal 2012,
primarily due to lower non-cash share-based compensation expense.
Net loss for the first quarter of fiscal 2013 was $8.5 million ($0.05 per share)
compared to $0.9 million ($0.01 per share) for the same period last year.
As at September 30, 2012 the Company had cash and short-term deposits totaling
$125.5 million and accounts payable and accrued liabilities totaling $5.0
million compared to $132.5 million and $3.1 million respectively as at June 30,
2012.
As at September 30, 2012 the Company had 157,546,793 common shares and 7,366,418
warrants outstanding.
Notice of Meeting: YM's Annual Meeting of Shareholders will be held on November
20, 2012, at 4:00 p.m. ET at the offices of Norton Rose Canada LLP, Boardrooms A
& B, 38th Floor, 200 Bay Street, Royal Bank Plaza South Tower, Toronto, Ontario.
The management proxy circular documents and annual financial documents were
mailed to shareholders on October 8, 2012, and are available online at
www.ymbiosciences.com, www.edgar.com and www.sedar.com.
About YM BioSciences YM BioSciences Inc. is a drug development company primarily
focused on advancing CYT387, an orally administered inhibitor of both the JAK1
and JAK2 kinases, which have been implicated in a number of hematological and
immune cell disorders including myeloproliferative neoplasms and inflammatory
diseases as well as certain cancers. Positive interim results have been reported
from a Phase I/II trial of CYT387 in 166 patients with myelofibrosis. YM's
portfolio also includes nimotuzumab, a humanized monoclonal antibody targeting
EGFR with an enhanced side-effect profile over currently marketed EGFR-targeting
antibodies. Nimotuzumab is being evaluated in numerous Phase II and III trials
worldwide. In addition, YM has several preclinical programs underway with
candidates from its library of novel compounds identified through internal
research conducted at YM BioSciences Australia.
News for 'YMI' - (YM BioSciences JAK Inhibitor CYT387 Produces Meaningful Reductions of Splenomegaly and Durable Transfusion Independence Responses)
MISSISSAUGA, ON, Nov. 5, 2012, 2012 (Canada NewsWire via COMTEX) -- YM
BioSciences Inc. (NYSE MKT: YMI, TSX: YM), a drug development company advancing
hematology and cancer related products, today reported interim results from the
Phase I/II study of CYT387, a JAK1/JAK2 inhibitor currently being evaluated for
the treatment of myelofibrosis, which were included in an abstract submitted to
the American Society of Hematology in August 2012. Updated results will be
presented in an Oral Session at the 2012 Annual Meeting of the American Society
of Hematology to be held in Atlanta, Georgia on December 9, 2012.
"Treatment with CYT387 provides sustained transfusion independence in a
substantial number of patients with myelofibrosis. In addition, many patients
experience rapid, meaningful and durable reductions of splenomegaly and
improvements of constitutional symptoms. CYT387 has also proven safe for
patients and well-tolerated, even with prolonged administration of more than two
and a half years," said Mark Kowalski, M.D., Ph.D., Chief Medical Officer and
Vice President, Regulatory Affairs at YM BioSciences. "We look forward to
expanding on these results at ASH when we report final nine-month data from this
trial."
The CYT387 Phase I/II study enrolled 166 patients across six study sites. At the
time the ASH abstract was submitted, the median duration of follow-up was 16.1
months (ongoing) with a range of 0.7 to 31.0 months (ongoing).
-- Durable transfusion independence responses were observed in
more than half of the RBC transfusion dependent subjects with a
maximal transfusion-free period exceeding two years and
ongoing. In addition, the percentage of all subjects requiring
RBC transfusions substantially decreased over the treatment
period.
-- Treatment with CYT387 resulted in rapid and sustained
reductions in splenomegaly with a maximal response duration
approaching two years.
-- The majority of subjects reporting constitutional symptoms at
baseline experienced complete resolution or marked improvement
by six months with measurable improvement within the first
month of therapy.
-- Higher transfusion independence and spleen response rates were
seen in the 300mg dose group compared to the 150mg QD or 150mg
BID dose groups.
-- While 90% of subjects reported at least one treatment-related
AE, the majority were reported as Grade 1.
For the first 60 consecutively enrolled subjects for whom the most mature data
is available, the median follow-up period was 21.5 months (ongoing) with a range
of 2.9 to 31.0 months (ongoing).
-- The anemia and spleen response rates in these subjects, per
IWG-MRT (International Working Group for Myeloproliferative
Neoplasms Research and Treatment), were 59% and 48%,
respectively.
-- Among 33 of these subjects who were RBC transfusion dependent
by IWG-MRT criteria, 70% achieved a minimum 12-week period
without transfusions, with a maximal transfusion-free period of
greater than two years and ongoing.
ASH Oral Session:
Title: Phase I/II Study of CYT387, a JAK1/JAK2 Inhibitor for the Treatment of
Myelofibrosis Session Name: 634. Myeloproliferative Syndromes - Clinical:
Myeloproliferative Neoplasms - Novel Therapies I Session Date: Sunday, December
9, 2012; 4:30 PM - 6:00 PM (Presentation Time: 5:15 PM) Location: Georgia World
Congress Center, Room B213-B214
About CYT387:
CYT387 is an orally administered inhibitor of both the JAK1 and JAK2 kinases,
which have been implicated in a family of hematological conditions known as
myeloproliferative neoplasms, including myelofibrosis, and as well in numerous
other disorders including indications in hematology, oncology and inflammatory
diseases. Myelofibrosis is a chronic debilitating disease in which a patient's
bone marrow is replaced by scar tissue and for which treatment options are
limited or unsatisfactory. Both the U.S. Food and Drug Administration (FDA) and
the European Commission have designated CYT387 an Orphan Drug for the treatment
of myelofibrosis.
About YM BioSciences
YM BioSciences Inc. is a drug development company primarily focused on advancing
CYT387, an orally administered inhibitor of both the JAK1 and JAK2 kinases,
which have been implicated in a number of hematological and immune cell
disorders including myeloproliferative neoplasms and inflammatory diseases as
well as certain cancers. Positive interim results have been reported from a
Phase I/II trial of CYT387 in 166 patients with myelofibrosis. YM's portfolio
also includes nimotuzumab, a humanized monoclonal antibody targeting EGFR with
an enhanced side-effect profile over currently marketed EGFR-targeting
antibodies. Nimotuzumab is being evaluated in numerous Phase II and III trials
worldwide. In addition, YM has several preclinical programs underway with
candidates from its library of novel compounds identified through internal
research conducted at YM BioSciences Australia.
This press release may contain forward-looking statements, which reflect the
Company's current expectation regarding future events. These forward-looking
statements involve risks and uncertainties that may cause actual results, events
or developments to be materially different from any future results, events or
developments expressed or implied by such forward-looking statements. Such
factors include, but are not limited to, changing market conditions, the
successful and timely completion of clinical studies, the establishment of
corporate alliances, the impact of competitive products and pricing, new product
development, uncertainties related to the regulatory approval process or the
ability to obtain drug product in sufficient quantity or at standards acceptable
to health regulatory authorities to complete clinical trials or to meet
commercial demand; and other risks detailed from time to time in the Company's
ongoing quarterly and annual reporting. Certain of the assumptions made in
preparing forward-looking statements include but are not limited to the
following: that CYT387 and nimotuzumab will generate positive efficacy and
safety data in ongoing and future clinical trials, and that YM as well as
CIMYM's various licensees will complete their respective clinical trials and
disclose data within the timelines communicated in this release. Except as
required by applicable securities laws, we undertake no obligation to publicly
update or revise any forward-looking statements, whether as a result of new
information, future events or otherwise.
SOURCE: YM BioSciences Inc.
To view this news release in HTML formatting, please use the following URL:
http://www.newswire.ca/en/releases/archive/November2012/05/c4910.html
SOURCE: YM BioSciences Inc.
Company is running on very thin ice with investors.By the looks of this selling its losing some big institutional investors.. will it run again,its been running only down.....rareF
YMI will run again at some point. It always seems to bounce back.
very true, unfortunately
YMI has been one lousy performer this year......rareF
News for 'YMI' - (YM BioSciences Reports CYT387 Phase I/II Results Selected for Oral Presentation at ASH2012 Conference)
MISSISSAUGA, ON, Oct. 11, 2012, 2012 (Canada NewsWire via COMTEX) -- YM
BioSciences Inc. (NYSE MKT: YMI, TSX: YM), a drug development company advancing
hematology and cancer related products, today announced that the results of its
Phase I/II Study of CYT387, a JAK1/JAK2 inhibitor currently being evaluated for
the treatment of myelofibrosis, have been selected by the ASH Program Committee
for presentation in an Oral Session at the 2012 Annual Meeting of the American
Society of Hematology to be held in Atlanta, Georgia on December 9, 2012.
"CYT387 could prove to be an important and differentiated therapeutic for
patients with myelofibrosis; the interim data we have reported to date have been
highly encouraging," said Dr. Nick Glover, President and CEO of YM BioSciences.
"We look forward to the release of final nine-month data from the Phase I/II
CYT387 study at ASH, as well as further ongoing data from the many patients who
continue to benefit from the drug in its Extension trial."
Title: Phase I/II Study of CYT387, a JAK1/JAK2 Inhibitor for the Treatment of
Myelofibrosis Session Name: 634. Myeloproliferative Syndromes - Clinical:
Myeloproliferative Neoplasms - Novel Therapies I Session Date: Sunday, December
9, 2012; 4:30 PM - 6:00 PM (Presentation Time: 5:15 PM) Location: Georgia World
Congress Center, Room B213-B214
AboutYM BioSciences YM BioSciences Inc.is a drug development company primarily
focused on advancing CYT387, an orally administered inhibitor of both the JAK1
and JAK2 kinases, which have been implicated in a number of hematological and
immune cell disorders including myeloproliferative neoplasms and inflammatory
diseases as well as certain cancers. Positive interim results have been reported
from a Phase I/II trial of CYT387 in 166 patients with myelofibrosis. YM's
portfolio also includes nimotuzumab, a humanized monoclonal antibody targeting
EGFR with an enhanced side-effect profile over currently marketed EGFR-targeting
antibodies. Nimotuzumab is being evaluated in numerous Phase II and III trials
worldwide. In addition, YM has several preclinical programs underway with
candidates from its library of novel compounds identified through internal
research conducted at YM BioSciences Australia.
This press release may contain forward-looking statements, which reflect the
Company's current expectation regarding future events. These forward-looking
statements involve risks and uncertainties that may cause actual results, events
or developments to be materially different from any future results, events or
developments expressed or implied by such forward-looking statements. Such
factors include, but are not limited to, changing market conditions, the
successful and timely completion of clinical studies, the establishment of
corporate alliances, the impact of competitive products and pricing, new product
development, uncertainties related to the regulatory approval process or the
ability to obtain drug product in sufficient quantity or at standards acceptable
to health regulatory authorities to complete clinical trials or to meet
commercial demand; and other risks detailed from time to time in the Company's
ongoing quarterly and annual reporting. Certain of the assumptions made in
preparing forward-looking statements include but are not limited to the
following: that CYT387 and nimotuzumab will generate positive efficacy and
safety data in ongoing and future clinical trials, and that YM as well as
CIMYM's various licensees will complete their respective clinical trials and
disclose data within the timelines communicated in this release. Except as
required by applicable securities laws, we undertake no obligation to publicly
update or revise any forward-looking statements, whether as a result of new
information, future events or otherwise.
SOURCE: YM BioSciences Inc.
To view this news release in HTML formatting, please use the following URL:
http://www.newswire.ca/en/releases/archive/October2012/11/c6015.html
SOURCE: YM BioSciences Inc.
7:22AM YM BioSciences reports Q4 loss of ($0.04) vs $0.00 single estimate; revs rose 50% to 300K (no rev est) (YMI) 1.78 : Interim data from the extension trial, in which patients who have completed the 166 patient Phase I/II trial are able to continue long-term treatment with CYT387, are expected to be reported by the end of calendar 2012. Initial data from the Phase II BID trial are expected to be reported by the end of calendar 2012.
News for 'YMI' - (YM BioSciences Reports Fiscal 2012 Operational and Financial Results)
MISSISSAUGA, ON, Sep. 21, 2012, 2012 (Canada NewsWire via COMTEX) -- -
Completed dosing for 166 patient CYT387 Phase I/II nine-month trial -
- Completed enrolment of 61 patient CYT387 Phase II BID trial -
YM BioSciences Inc. (NYSE MKT: YMI, TSX: YM), a drug development company
advancing hematology and cancer related products, today reported operational and
financial results for its 2012 fiscal year, ended June 30, 2012.
"We made significant progress with CYT387 during Fiscal 2012, highlighted by our
reporting at ASH 2011 of positive interim data that potentially differentiates
our drug from other JAK inhibitors. Leveraging these data, over the last several
months we conducted productive discussions with regulatory authorities in the US
and Europe which have affirmed the range of options available for the pivotal
program for CYT387," said Dr. Nick Glover, President and CEO of YM BioSciences.
"We continue to conduct a robust business development campaign aimed at
exploring potential opportunities to further develop and commercialize the drug
with other companies, seeking relationships that will focus on realizing the
broader commercial opportunity for CYT387."
Fiscal 2012 Highlights:
CYT387:
-- In December 2011, interim results for all 166 patients enrolled
in the Phase I/II trial were reported in a poster session at
ASH 2011. In this multicenter setting, CYT387 enabled more than
half of the patients with myelofibrosis who were initially
dependent on transfusions to become transfusion independent for
clinically relevant periods of time. CYT387 also continued to
produce significant and durable reductions of splenomegaly and
improvements of constitutional symptoms for many patients.
CYT387 was safe and well tolerated, with daily dosing up to and
exceeding two and a half years.
-- In June 2012, all eligible patients completed the core study of
the Phase I/II trial by receiving drug for nine months. These
patients are eligible to continue receiving drug in the ongoing
extension trial.
-- In July 2012, enrolment was completed for the complementary
Phase II BID (twice-daily dosing) trial of CYT387 initiated in
September 2011. This trial was designed to further explore the
range of potential dosing for CYT387 and recruited a total of
61 patients at six sites across North America. A review of
clinical data obtained across multiple doses and schedules
indicates that the optimal dose for CYT387 is 300mg given
once-daily. Additional findings from the BID study will augment
the data from the 166 patient Phase I/II study and facilitate
further investigation of the spleen, constitutional symptom and
anemia responses observed to date.
-- In mid-calendar 2012, meetings with US and European regulators
were conducted where potential pivotal Phase III clinical trial
designs to support marketing approval for CYT387 were
discussed. YM believes these discussions were productive,
confirming that several options were available for the pivotal
clinical development program of CYT387.
-- YM is exploring potential opportunities to further develop and
commercialize CYT387 with other companies, seeking
relationships that will focus on realizing the broader
commercial opportunity for CYT387 in myelofibrosis and beyond.
In February 2012, YM raised US$80.5 million, providing the
Company with flexibility to weigh any business development
opportunities that arise against the prospect of retaining full
control over commercial economics by advancing CYT387 further
into pivotal trials on its own.
CYT387 Next Steps:
-- Final nine-month data from the ongoing 166 patient Phase I/II
trial are expected to be reported by the end of calendar 2012.
-- Interim data from the extension trial, in which patients who
have completed the 166 patient Phase I/II trial are able to
continue long-term treatment with CYT387, are expected to be
reported by the end of calendar 2012.
-- Initial data from the Phase II BID trial are expected to be
reported by the end of calendar 2012.
-- Having reported positive interim data in December 2011 from a
166 patient Phase I/II trial of CYT387 in myelofibrosis, YM
conducted productive discussions with regulatory authorities in
the US and Europe which have affirmed the range of options
available for the pivotal program for CYT387. YM is now
preparing for pivotal trials under scenarios where the drug is
developed either with or without another company.
Nimotuzumab:
-- YM has been advised by Daiichi Sankyo Co., Ltd., CIMYM's
sub-licensee for nimotuzumab in Japan, that they are evaluating
the drug in a Phase II gastric cancer program together with
Kuhnil Pharma Co. Ltd., CIMYM's sub-licensee in South Korea,
and in a Phase II non-small cell lung cancer (NSCLC) program.
-- YM has been advised by Oncoscience AG (OSAG), CIMYM's
sub-licensee for Europe, that they are evaluating nimotuzumab
in Phase III glioma and pancreatic cancer programs.
-- YM has been advised by Innogene Kalbiotech PTE Ltd. (IGK), a
CIMYM sub-licensee, that they are evaluating nimotuzumab in
Phase II and III head and neck cancer programs and a Phase II
cervical cancer program.
CYT997:
-- A single-arm intravenous Phase Ib/II study in patients with
relapsed glioblastoma multiforme was closed to enrolment in
February 2011. Subsequent preclinical work was recently
completed involving the examination of repeated low doses of
CYT997, the envisioned optimal dosing regimen for this drug, in
a mouse breast cancer model. Based on the results obtained in
this preclinical model, in conjunction with the earlier
clinical trial data, YM has decided not to pursue further
clinical development of CYT997 at this time.
Summary Financial Results (CDN dollars) The interim consolidated financial
statements and comparative information for fiscal 2012 have been prepared in
accordance with International Financial Reporting Standards ("IFRS"). The
Company's Consolidated Financial Statements were previously prepared in
accordance with Canadian Generally Accepted Accounting Principles ("Canadian
GAAP").
Revenue, generated from out-licensing, for the fourth quarter of fiscal 2012
ended June 30, 2012 was $0.3 million compared with $0.2 million for the fourth
quarter of fiscal 2011. Revenue for fiscal 2012 of $1.1 million is comparable to
$1.0 million for fiscal 2011.
Net finance income was $2.2 million for the fourth quarter of fiscal 2012
compared to net finance costs of $0.5 million for the fourth quarter of fiscal
2011. Net finance income was $11.4 million for fiscal 2012 compared to net
finance costs of $10.3 million for fiscal 2011. The changes in net finance
income are primarily attributable to changes in the fair value adjustment for
USD warrants. Under IFRS, warrants denominated in a different currency than the
Company's functional currency must be classified as a financial liability and
measured at fair value, with changes reflected in profit or loss. For the fourth
quarter of fiscal 2012, the Company incurred a gain of $0.4 million on the
revaluation of warrants, compared to a loss of $0.8 million for the fourth
quarter of fiscal 2011. For fiscal 2012, the Company incurred a gain of $7.3
million on the revaluation of warrants, compared to a loss of $9.4 million for
fiscal 2011.
Licensing and product development expenses were $7.1 million for the fourth
quarter of fiscal 2012 compared with $7.4 million for the fourth quarter of
fiscal 2011. Licensing and product development expenses were $26.6 million for
fiscal 2012 compared with $23.8 million for fiscal 2011. Development expenses
for CYT387 increased due to the extension of the Phase I/II clinical trial in
myelofibrosis, start-up costs associated with the BID study, pre-clinical
development activities, and manufacturing of drug for these programs. Expenses
for nimotuzumab continued to decrease.
General and administrative expenses were $1.4 million for the fourth quarter of
fiscal 2012 compared to $1.2 million for the fourth quarter of fiscal 2011.
General and administrative expenses were $6.2 million for fiscal 2012 compared
to $7.7 million for fiscal 2011, primarily due to reduced salary expense after
the reorganization termination payments in fiscal 2011.
Net loss for the fourth quarter of fiscal 2012 was $6.1 million ($0.04 per
share) compared to $8.9 million ($0.08 per share) for the same period last year.
Net loss for fiscal 2012 was $20.3 million ($0.16 per share) compared to $40.9
million ($0.42 per share) for fiscal 2011.
As at June 30, 2012 the Company had cash and short-term deposits totaling $132.5
million and accounts payable and accrued liabilities totaling $3.1 million
compared to $79.7 million and $4.4 million respectively at June 30, 2011.
As at June 30, 2012 the Company had 157,546,793 common shares and 7,366,418
warrants outstanding.
Notice of Meeting: YM's Annual Meeting of Shareholders will be held on November
20, 2012, at 4:00 p.m. ET at the offices of Norton Rose OR LLP, Boardrooms A &
B, 38th Floor, 200 Bay Street, Royal Bank Plaza South Tower, Toronto, Ontario.
The management proxy circular documents and annual financial documents are
expected to be mailed to shareholders on October 8, 2012, and will be available
online at www.ymbiosciences.com, www.sec.gov and www.sedar.com.
About YM BioSciences YM BioSciences Inc. is a drug development company primarily
focused on advancing CYT387, an orally administered inhibitor of both the JAK1
and JAK2 kinases, which have been implicated in a number of hematological and
immune cell disorders including myeloproliferative neoplasms and inflammatory
diseases as well as certain cancers. Positive interim results have been reported
from a Phase I/II trial of CYT387 in 166 patients with myelofibrosis. YM's
portfolio also includes nimotuzumab, a humanized monoclonal antibody targeting
EGFR with an enhanced side-effect profile over currently marketed EGFR-targeting
antibodies. Nimotuzumab is being evaluated in numerous Phase II and III trials
worldwide. In addition, YM has several preclinical programs underway with
candidates from its library of novel compounds identified through internal
research conducted at YM BioSciences Australia.
This press release may contain forward-looking statements, which reflect the
Company's current expectation regarding future events. These forward-looking
statements involve risks and uncertainties that may cause actual results, events
or developments to be materially different from any future results, events or
developments expressed or implied by such forward-looking statements. Such
factors include, but are not limited to, changing market conditions, the
successful and timely completion of clinical studies, the establishment of
corporate alliances, the impact of competitive products and pricing, new product
development, uncertainties related to the regulatory approval process or the
ability to obtain drug product in sufficient quantity or at standards acceptable
to health regulatory authorities to complete clinical trials or to meet
commercial demand; and other risks detailed from time to time in the Company's
ongoing quarterly and annual reporting. Certain of the assumptions made in
preparing forward-looking statements include but are not limited to the
following: that CYT387 and nimotuzumab will generate positive efficacy and
safety data in ongoing and future clinical trials, and that YM as well as
CIMYM's various licensees will complete their respective clinical trials and
disclose data within the timelines communicated in this release. Except as
required by applicable securities laws, we undertake no obligation to publicly
update or revise any forward-looking statements, whether as a result of new
information, future events or otherwise.
YM BIOSCIENCES INC. Consolidated Statements of Financial Position (Expressed in
Canadian dollars, unless otherwise noted)
June 30, June 30, July 1,
2012 2011 2010
Assets
Current assets:
Cash and cash
equivalents $ 87,140,020 $ 32,046,630 $ 19,460,141
Short-term
deposits 45,310,288 47,611,922 26,184,991
Accounts
receivable 252,884 205,900 161,184
Prepaid
expenses 257,780 731,676 237,962
Total current
assets 132,960,972 80,596,128 46,044,278
Non-current
assets:
Property and
equipment 62,118 91,320 84,775
Intangible
assets 2,629,682 7,137,698 11,645,714
Total
non-current
assets 2,691,800 7,229,018 11,730,489
Total assets $ 135,652,772 $ 87,825,146 $ 57,774,767
Liabilities and
Equity
Current
liabilities:
Accounts
payable $ 803,421 $ 1,718,893 $ 699,277
Accrued
liabilities 2,262,972 2,652,511 2,085,824
Share
purchase
warrants 7,221,040 14,476,681 6,358,480
Deferred
revenue 381,270 594,072 1,523,916
Total current
liabilities 10,668,703 19,442,157 10,667,497
Non-current
liabilities:
Deferred
revenue 1,556,853 1,831,722 1,650,909
Total
non-current
liabilities 1,556,853 1,831,722 1,650,909
Equity:
Share
capital 340,173,078 264,548,643 203,498,239
Contributed
surplus 16,712,315 15,144,062 14,232,353
Deficit (233,458,177) (213,141,438) (172,274,231)
Total equity 123,427,216 66,551,267 45,456,361
Total
liabilities and
equity $ 135,652,772 $ 87,825,146 $ 57,774,767
YM BIOSCIENCES INC. Consolidated Statements of Loss and Comprehensive Loss
(Expressed in Canadian dollars, unless otherwise noted)
Years ended June 30, 2012 and
2011
2012 2011
Revenue:
Out-licensing $ 1,070,665 $ 1,033,239
1,070,665 1,033,239
Expenses:
Licensing and product
development 26,643,838 23,821,980
General and
administrative 6,175,132 7,739,857
32,818,970 31,561,837
Loss before financial
results (31,748,305) (30,528,598)
Finance income 11,431,566 480,314
Finance costs - (10,818,923)
Net loss and comprehensive
loss for the year $ (20,316,739) $ (40,867,207)
Basic and diluted loss per
common share $ (0.16) $ (0.42)
YM BIOSCIENCES INC. Consolidated Statements of Changes in Equity (Expressed in
Canadian dollars, unless otherwise noted)
Years ended June 30, 2012 and 2011
Share capital Contributed
Number Amount surplus Deficit Total
Balance, June
30, 2011 116,681,948 $ 264,548,643 $ 15,144,062 $ (213,141,438) $ 66,551,267
Net loss and
comprehensive
loss for the
year - - - (20,316,739) (20,316,739)
Transactions
with owners of
the Company,
recognized
directly in
equity:
Shares issued
pursuant to
prospectus
offering 40,250,000 74,232,207 - - 74,232,207
Shares issued
on exercise
of options 614,845 1,392,228 (670,529) - 721,699
Share-based
compensation - - 2,238,782 - 2,238,782
Total
transactions
with owners
of the
Company 40,864,845 75,624,435 1,568,253 - 77,192,688
Balance, June
30, 2012 157,546,793 $ 340,173,078 $ 16,712,315 $ (233,458,177) $ 123,427,216
Share capital Contributed
Number Amount surplus Deficit Total
Balance, July
1, 2010 80,359,623 $ 203,498,239 $ 14,232,353 $ (172,274,231) $ 45,456,361
Net loss and
comprehensive
loss for the
year - - - (40,867,207) (40,867,207)
Transactions
with owners of
the Company,
recognized
directly in
equity:
Shares issued
on exercise
of options 1,074,077 1,965,590 (798,279) - 1,167,311
Shares issued
on exercise
of warrants 723,248 2,375,179 - - 2,375,179
Shares issued
pursuant to
prospectus
offering 34,525,000 56,709,635 - - 56,709,635
Share-based
compensation - - 1,709,988 - 1,709,988
Total
transactions
with owners
of the
Company 36,322,325 61,050,404 911,709 - 61,962,113
Balance, June
30, 2011 116,681,948 $ 264,548,643 $ 15,144,062 $ (213,141,438) $ 66,551,267
YM BIOSCIENCES INC. Consolidated Statements of Cash Flows (Expressed in Canadian
dollars, unless otherwise noted)
Years ended June 30, 2012 and
2011
2012 2011
Cash provided by (used in):
Operating activities:
Net loss for the year $ (20,316,739) $ (40,867,207)
Items not involving cash:
Depreciation of property
and equipment 57,359 78,533
Amortization of
intangible assets 4,508,016 4,508,016
Interest income (716,799) (469,191)
Unrealized (gain) loss on
cash and cash
equivalents (1,269,907) 1,407,760
Gain on disposal of
property and equipment - (13,394)
Share-based
compensation 2,238,782 1,709,988
Change in fair value of
share purchase warrants (7,255,641) 9,411,162
Changes in non-cash working
capital balances:
Short-term deposits (598,996) (417,445)
Accounts receivable (46,984) (44,716)
Prepaid expenses 473,896 (493,714)
Accounts payable (915,472) 1,019,616
Accrued liabilities (389,539) 566,687
Deferred revenue (487,671) (749,031)
Net cash used in operating
activities (24,719,695) (24,352,936)
Investing activities:
Proceeds from sale of
short-term deposits 49,200,630 67,505,054
Purchase of short-term
deposits (46,300,000) (88,514,540)
Interest received 716,799 469,191
Additions to property and
equipment (28,157) (71,684)
Net cash provided by (used
in) investing activities 3,589,272 (20,611,979)
Financing activities:
Issuance of common shares
on exercise of options 721,699 1,167,311
Issue of common shares on
exercise of warrants &
I picked up 20k shares today YMI and PPHM both ready to hockeystick good luck longs.
Time to BUY a few !
YM BioSciences Inc. looks like it's trying to rock its way out of a consolidation phase (orange), and the tail end of a converging wedge (blue). Though YMI hasn't busted out of either confine yet, it is finding support at key moving averages, most of which have already bullishly crossed one another. While not complete, reading between the lines we can sense that a breakout storm is brewing.
YMI is, as the name would suggest, a biotech stock. It's developing a handful of cancer therapies, though its flagship drug is CYT387, for treating myelofibrosis. It's in Phase 2 trials right now. While YM BioSciences may be at least a couple of years away from getting any of its R&D projects approved, banks, brokerage, and research firms have made no bones about their love and hope for the stock. That bullish banter alone could be enough to light a fire under the stock again, and erase last year's tumble from a price of more than $3.00. The spring sure looks coiled anyway.
YM BioSciences, Inc. (AMEX:YMI): After Incyte (NASDAQ:INCY) reported high initial levels of patient discontinuations in a study of Jakafi for myelofibrosis, YM Biosciences shares, which has a similar drug, fell on Friday, according to JMP Securities. The firm thinks that YM Biosciences’ drug could be better suited for patients with anemia. The firm keeps and Outperform rating and a $5 target on the stock.
Havent sold any yet. Thats a nice size though.
I saw that too rarefind, hmmmm
No news but a 26,063 share block just traded pre-market at 2.02 strong buy....rareF
I think the 52 week high falls within 90 days, jmo!
heading above the 2.29 range today and then break resistance at 2.47. YMI is under valued compared to incy, strong buy.....rareF
Chart looks amazing!!!!
Nice quite board as ymi stealth's slowly higher......strong buy...rareF
Interesting, I show YMI at 5.25 in the next 12 months, so we are in the same ballpark!
Got my 2.30s welcome mat down, this stocks got major upside......and its on the way......near term 3.50......then to the 5s-6s buck a share range on good trial results....strong buy....rareF
Thanks rarefind!
Looking very strong
YMI is just starting its move, major upside, 3.50 near term....strong buy...rareF
no arguments here, I'm locked and loaded
YMI getting ready to move big...strong buy...rareF..imo
YMI
These Biotechs May Break Out While Vivus And Arena Battle It Out
http://seekingalpha.com/article/620871-these-biotechs-may-break-out-while-vivus-and-arena-battle-it-out?source=yahoo
Ah, yes. Good input to have. TY:)
NP, I just make it up as I go along;)
I think $2.50 might be a key level based on option strikes. We'll see.
good stuff otterman, thanks!
SAR flipped Jan 30 and has been pushing in our favor since Apr 23. MACD has crossed into positive territory. RSI moving in our favor. Acccumulation since the beginning of April. A passover of the 50 price channels center at 2.34. Small resistance at 3.00. Then off to 3.65.
But that 2.20 range has been our ball buster, as the article says we have to break through with a vengence.
GL
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YMI BioSciences, Inc.
CYT997 has completed two Phase I studies in advanced solid tumors and is currently being studied in a Phase II clinical trial in combination with chemotherapy in patients with relapsed glioblastoma multiforme. Results from the intravenous Phase I dose escalation study were published in the British Journal of Cancer (Lickliter et al, 2010), and demonstrated clinically meaningful disease stabilization in the majority of patients treated. Data showed that CYT997 administration was associated with changes in plasma and imaging biomarkers consistent with vascular disruption in tumors. Magnetic resonance imaging showed significant changes in tumor perfusion consistent with vascular disruption in some patients. Data from the Phase I oral study of CYT997 in patients with advanced cancer were reported at ASCO 2009 (Francesconi et al, 2009).
2011 2nd Quarter http://www.ymbiosciences.com/upload_files/YM_Q2_2011.pdf
2011 3rd Quarter http://www.otcmarkets.com/stock/YMI/news
2010 Annual Report 10-K http://www.ymbiosciences.com/upload_files/YM_AR_2010.pdf
Website http://www.ymbiosciences.com/
Yahoo Finance http://finance.yahoo.com/q/h?s=YMI
Google Finance http://finance.google.com/finance?client=ob&q=YMI
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