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nice move today
nice move today
I added a bit earlier here but not too far from current price. So many shorts in this. With new CEO PPS has stabilized IMO and with news and upcoming asco this will start running. All IMO.
Cool! Good luck to you and me. :)
Sheff bought in @ 1.13
Bid has inched up AH decent size at 5k showing.
Looks like some shorts are trying to cover, Nasdaq showing over 8%. About 50K showing on the bid $1.15-$1.18. Possible squeeze? $ONCY
What wrong with this stock ??? Cuz healthcare sector very strong up today .
Already have it on the watch list : )
Look at *TP*V as well. I gave you a follow.
Expecting a run to $1.50+ here real soon
$ONTY took a starter here this morning
We all need to thank Clay for bring this to the shorts attention. He killed the rally.
* * $ONTY Video Chart 03-18-16 * *
Link to Video - click here to watch the technical chart video
Huge volume today. Nice to see it green for a change.
yea...this is beautiful. GREEN!! Solid Company. Those Institutionals are not dumb.
Figured an up ONTY day was in store when I saw the 127K buy at open. Nice rebound.
Me too! Interesting how this stock continues to get beat up considering the number of institutional holders.
ONTY: Oncothyreon Reports Full Year and Fourth Quarter 2015 Financial Results & Provides Corporate Update
--Initiated Phase 2 ONT-380 Trial Based on Encouraging Combination Data--
--$56M in Cash and Investments at December 31, 2015--
SEATTLE, March 14, 2016 (GLOBE NEWSWIRE) -- Oncothyreon Inc. (NASDAQ:ONTY), a clinical-stage biopharmaceutical company dedicated to the development of therapeutic products that can improve the lives and outcomes of patients with cancer, today provided a corporate update and reported financial results for the year and quarter ended December 31, 2015.
"2015 was a significant year for Oncothyreon, with the company reporting encouraging data from two combination trials of ONT-380 demonstrating that this product candidate may be impactful on HER2-positive breast cancer patients, including those with brain metastases -- a patient population in desperate need of new treatment options," said Christopher S. Henney, Chairman and interim CEO of Oncothyreon. "We believe our clinical results to date provided a strong foundation for us to advance ONT-380 into our recently initiated randomized, double-blind, placebo-controlled Phase 2 trial in combination with Herceptin and Xeloda, which includes enrolling patients with progressing central nervous system disease."
Corporate Update & Recent Highlights
Clinical Development:
-- ONT-380 Phase 2 Combination Trial Underway in Patients with HER2-Positive
Breast Cancer. The randomized, double-blind, placebo control trial is
evaluating ONT-380 in combination with Herceptin(R) (trastuzumab) and
Xeloda(R) (capecitabine). ONT-380 is an oral, HER2-selective, central
nervous system (CNS)-active tyrosine kinase inhibitor. The trial is
targeted to enroll approximately 180 heavily pretreated patients with
advanced HER2-positive breast cancer who present with or without brain
metastases. Building on encouraging Phase 1b results, the primary and
secondary endpoint objectives are designed to measure ONT-380's
contribution on both systemic and CNS disease, an area of unmet need for
patients.
-- Data from Ongoing ONT-380 Phase 1b Combination Trials Show Objective,
Durable Responses and Favorable Tolerability Profile. During 2015, data
from two ongoing trials of ONT-380 were presented at the American Society
of Clinical Oncology (ASCO) and the San Antonio Breast Cancer Symposium
(SABCS).
-- ONT-380 in combination with Xeloda and/or Herceptin:
-- This Phase 1b trial enrolled patients with metastatic
HER2-positive breast cancer with progression following prior
treatment with Herceptin and Kadcyla(R) (ado-trastuzumab emtansine
or T-DM1). In addition to patients without a prior history of CNS
disease, patients with untreated, asymptomatic CNS disease and
patients with progressing CNS disease after prior local therapy
were allowed to enroll in the trial and were followed for
responses both systemically and in the CNS. Overall, ONT-380 in
combination with Xeloda, Herceptin or both Xeloda and Herceptin
has been well tolerated. As reported at ASCO 2015, in a total of
32 patients treated with these combinations, the majority of
adverse events were Grade 1 or 2 in severity, with no reported
Grade 3 diarrhea. As reported at SABCS 2015, the objective
response rate across treatment groups was 42 percent and the CNS
response rate was 33 percent, providing encouraging data to
support moving forward with a follow-on Phase 2 study of ONT-380
in combination with Xeloda and Herceptin.
-- ONT-380 in combination with Kadcyla:
-- This Phase 1b trial enrolled patients with metastatic
HER2-positive breast cancer with progression following prior
treatment with Herceptin and a taxane. Patients may have received
prior treatment with Perjeta(R) (pertuzumab) and Tykerb(R)
(lapatinib). Patients with or without brain metastases were
eligible. This trial has completed enrollment, but is ongoing with
patients continuing to receive treatment. Clinical data from this
trial were presented at SABCS 2014 and 2015, and at ASCO 2015.
Overall, the combination of ONT-380 and Kadcyla was clinically
well tolerated in 50 patients treated at the maximum tolerated
dose of ONT-380, with the majority of adverse events either Grade
1 or Grade 2 in severity. Grade 3 diarrhea was reported in 4
percent of patients. Durable (>6 months) systemic and CNS
responses and disease stabilization were seen, with an objective
response rate of 41 percent and a CNS response rate of 33 percent.
Internal Research & Discovery Collaborations:
-- Research Collaboration Moving Chk1 Inhibitors Forward. During 2015,
Oncothyreon continued preclinical activities to develop a small molecule
against the checkpoint kinase 1 (Chk1) target in collaboration with
Sentinel Oncology. IND-enabling studies are expected to begin in 2017.
-- Protocell Research Program Progressing. During 2015, Oncothyreon
continued research on protocells, a novel nanoparticle platform
technology that may enable the targeted delivery of a variety of
therapeutic agents.
Leadership:
-- Expanded Leadership Team, CEO Search Underway. In January 2016,
Oncothyreon announced the appointment of Christopher S. Henney, the
company's chairman, as interim CEO. The company's comprehensive search
for a new CEO is actively ongoing. Additionally, Oncothyreon appointed
three new members to its Board of Directors: Steven P. James in March
2015 and Mark Lampert and Gwen Fyfe, M.D. in January 2016.
Full Year and Fourth Quarter 2015 Financial Highlights
-- Cash, cash equivalents and investments totaled $56.4 million as of
December 31, 2015, compared to $63.7 million at December 31, 2014, a
decrease of $7.3 million, or 11.5%. The decrease was primarily
attributable to $28.9 million of cash used in operations during the year
ended December 31, 2015, partially offset by the net proceeds of $22.4
million from the closing of concurrent but separate underwritten
offerings of common stock and Series B convertible preferred stock in
February 2015.
-- Research and development expenses for the fourth quarter of 2015
decreased by $19.1 million to $6.9 million from $26.0 million in the
fourth quarter of 2014. Full year research and development expenses
decreased by $18.4 million to $23.5 million in 2015 from $41.9 million in
2014. The fourth quarter and full year decrease in expense was primarily
the result of the one-time upfront payment made to Array Biopharma in
December 2014.
-- General and administrative expenses for the fourth quarter of 2015
increased by $0.4 million to $2.3 million, from $1.9 million in the
fourth quarter of 2014. Full year 2015 general and administrative
expenses were $9.3 million, an increase of $0.3 million from $9.0 million
in 2014. This increase was primarily due to patent expenses related to
our product candidates.
-- Net loss for the year ended December 31, 2015 was $32.6 million, or $0.34
per basic and diluted share, compared with a net loss of $50.0 million,
or $0.64 per basic and diluted share, for the comparable period in 2014.
Net loss for the three months ended December 31, 2015 was $9.1 million,
or $0.10 per basic and diluted share, compared with a net loss of $27.6
million, or $0.30 per basic and diluted share, for the comparable period
in 2014. The decrease in net loss for the year and quarter was primarily
attributable to a $20.0 million upfront payment Oncothyreon made to Array
BioPharma upon entering into an exclusive license agreement in December
2014. The decrease in net loss was partly offset by slightly higher
general and administrative expenses and lower non-cash income from the
change in the fair value of our warrant liability.
Financial Guidance
Oncothyreon believes the following financial guidance to be correct as of the date provided. Oncothyreon is providing this guidance as a convenience to investors and assumes no obligation to update it.
Oncothyreon currently expects operating expenses in 2016 to be higher than in 2015. This increase will primarily be related to expenditures associated with the Phase 2 trial of ONT-380. Oncothyreon currently expects cash used in operations in 2016 to be approximately $38.0 million to $40.0 million. With cash, cash equivalents and investments of $56.4 million as of December 31, 2015, Oncothyreon estimates that its cash, cash-equivalents and investments will be sufficient to fund operations for at least the next 12 months.
About Oncothyreon
Oncothyreon is a clinical-stage biopharmaceutical company specializing in the development of innovative therapeutic products for the treatment of cancer. Our goal is to discover, develop and commercialize novel compounds that have the potential to improve the lives and outcomes of cancer patients. Our most advanced product candidate is ONT-380, an orally active and selective small molecule HER2 inhibitor. We are developing preclinical product candidates in oncology and immune-oncology using our protocell technology. For more information, visit www.oncothyreon.com.
Forward-Looking Statements
In order to provide Oncothyreon's investors with an understanding of its current results and future prospects, this release contains statements that are forward-looking. Any statements contained in this press release that are not statements of historical fact may be deemed to be forward-looking statements. Words such as "believes," "anticipates," "plans," "expects," "will," "intends," "potential," "possible" and similar expressions are intended to identify forward-looking statements. These forward-looking statements include Oncothyreon's expectations regarding clinical and preclinical development activities, potential benefits of its current and future product candidates, future expenses and the use and adequacy of cash resources.
Forward-looking statements involve risks and uncertainties related to Oncothyreon's business and the general economic environment, many of which are beyond its control. These risks, uncertainties and other factors could cause Oncothyreon's actual results to differ materially from those projected in forward-looking statements, including the risks associated with the costs and expenses of developing its product candidates, the adequacy of financing and cash, cash equivalents and investments, changes in general accounting policies, general economic factors, achievement of the results it anticipates from its preclinical development and clinical trials of its product candidates and its ability to adequately obtain and protect its intellectual property rights. Although Oncothyreon believes that the forward-looking statements contained herein are reasonable, it can give no assurance that its expectations are correct. All forward-looking statements are expressly qualified in their entirety by this cautionary statement. For a detailed description of Oncothyreon's risks and uncertainties, you are encouraged to review the documents filed with the securities regulators in the United States on EDGAR and in Canada on SEDAR. Except as required by law, Oncothyreon does not undertake any obligation to publicly update its forward-looking statements based on events or circumstances after the date hereof.
Additional Information
Additional information relating to Oncothyreon can be found on EDGAR at www.sec.gov and on SEDAR at www.sedar.com.
ONCOTHYREON INC. 2601 Fourth Avenue, Suite 500, Seattle, WA 98121
Tel: (206) 801-2100 Fax: (206) 801-2101
http://www.oncothyreon.com
Oncothyreon (NASDAQ:ONTY) Short Interest Increased By 4.33%
http://www.smallcapwired.com/oncothyreon-nasdaqonty-short-interest-increased-by-4-33/69189/
By Linda Rogers on March 4, 2016 Stock News
The stock of Oncothyreon (NASDAQ:ONTY) registered an increase of 4.33% in short interest. ONTY’s total short interest was 7.44M shares in March as published by FINRA. Its up 4.33% from 7.13M shares, reported previously. With 682,200 shares average volume, it will take short sellers 11 days to cover their ONTY’s short positions. The short interest to Oncothyreon’s float is 10.4%. The stock increased 4.31% or $0.05 during the last trading session, hitting $1.21. About 977,808 shares traded hands or 27.66% up from the average. Oncothyreon Inc (USA) (NASDAQ:ONTY) has declined 67.23% since July 29, 2015 and is downtrending. It has underperformed by 62.13% the S&P500.
Oncothyreon Inc. is a clinical-stage biopharmaceutical firm focused primarily on the development of therapeutic products for the treatment of cancer. The company has a market cap of $124.52 million. The Company’s clinical-stage product candidates include ONT-380, an orally active and selective small-molecule HER2 inhibitor, and ONT-10, a therapeutic vaccine targeting the Mucin 1 peptide antigen. It currently has negative earnings. The Firm is developing preclinical product candidates in oncology, and certain rare diseases, using its protocell technology.
The institutional sentiment decreased to 0.47 in 2015 Q3. Its down 1.17, from 1.64 in 2015Q2. The ratio worsened, as 22 funds sold all Oncothyreon Inc (USA) shares owned while 42 reduced positions. 9 funds bought stakes while 21 increased positions. They now own 55.19 million shares or 1.99% less from 56.32 million shares in 2015Q2.
Bvf Inc Il holds 9.06% of its portfolio in Oncothyreon Inc (USA) for 16.36 million shares. Venbio Select Advisor Llc owns 5.51 million shares or 3.92% of their US portfolio. Moreover, Perkins Capital Management Inc has 1.19% invested in the company for 390,650 shares. The California-based Ecor1 Capital Llc has invested 1.18% in the stock. Redmile Group Llc, a California-based fund reported 3.61 million shares.
Out of 4 analysts covering Oncothyreon (NASDAQ:ONTY), 4 rate it “Buy”, 0 “Sell”, while 1 “Hold”. This means 80% are positive. Oncothyreon was the topic in 5 analyst reports since August 7, 2015 according to StockzIntelligence Inc.
Jumped in just below $1 here
I bought at 1.07 yesterday
Why Franklin Resources Inc Reported Big Oncothyreon Inc Position?
http://www.fdanewsalert.com/why-franklin-resources-inc-reported-big-oncothyreon-inc-position/8511800/
Franklin Resources Inc filed with the SEC SC 13G form for Oncothyreon Inc. The form can be accessed here: 000003877716000406. As reported in Franklin Resources Inc’s form, the filler as of late owns 7.3% or 6,899,600 shares of the Health Care–company.
Oncothyreon Inc stake is a new one for the for this institutional investor and it was filed because of activity on December 31, 2015. We feel this shows Franklin Resources Inc’s positive view for the stock.
Why Franklin Resources Inc Reported Big Oncothyreon Inc Position?
Passive and Active Investment News
February 14, 2016 By Patrick Sproles
Franklin Resources Inc filed with the SEC SC 13G form for Oncothyreon Inc. The form can be accessed here: 000003877716000406. As reported in Franklin Resources Inc’s form, the filler as of late owns 7.3% or 6,899,600 shares of the Health Care–company.
Oncothyreon Inc stake is a new one for the for this institutional investor and it was filed because of activity on December 31, 2015. We feel this shows Franklin Resources Inc’s positive view for the stock.
Oncothyreon Inc Institutional Sentiment
Latest Security and Exchange filings show 87 investors own Oncothyreon Inc. The institutional ownership in Q3 2015 is high, at 58.14% of the outstanding shares. This is decreased by 1123001 the total institutional shares. 55193956 were the shares owned by these institutional investors. In total 9 funds opened new Oncothyreon Inc stakes, 21 increased stakes. There were 22 that closed positions and 42 reduced them.
Jeremy Green Redmile Group Llc is an institutional investor bullish on Oncothyreon Inc, owning 3614990 shares as of Q3 2015 for 0.21% of its portfolio. Perkins Capital Management Inc owns 390650 shares or 1.19% of its portfolio. CA Venbio Select Advisor Llc have 3.92% of their stock portfolio for 5506618 shares. Further, Ecor1 Capital Llc reported stake worth 1.18% of its US stock portfolio. The CA Bvf Inc owns 16360538 shares. Oncothyreon Inc is 9.06% of the manager’s US portfolio.
Business Profile
Oncothyreon Inc. (Oncothyreon) is a clinical-stage biopharmaceutical company focused primarily on the development of therapeutic products for the treatment of cancer. The Company’s clinical-stage product candidates include ONT-380, an orally active and selective small-molecule HER2 inhibitor, and ONT-10, a therapeutic vaccine targeting the Mucin 1 peptide antigen. The Company is developing preclinical product candidates in oncology, and certain rare diseases, using its protocell technology. It also collaborates with partners to discover and develop additional product candidates. The Company is developing a series of orally active Chk1 inhibitors in collaboration with Sentinel Oncology Ltd. The Company is focusing its activities with protocells on the delivery of mini-circle DNA or mRNA to produce proteins intracellularly in specifically targeted organs or cells. It is collaborating with Adimab LLC for the discovery of antibodies against undisclosed immunotherapy targets in oncology.
SEC Form 13G is required when the filer owns between (5% and 20%) of a company and plans to hold it only as a passive investor. In case the filler intend to exert control and the stake’s exceeds 20%, then 13D Form must be filed. These filings can NOT be a precursor to “change of control” events such as hostile takeovers, company breakups or others.
The institutional sentiment decreased to 0.47 in Q3 2015. Its down 1.17, from 1.64 in 2015Q2. The ratio worsened, as 22 funds sold all Oncothyreon Inc (USA) shares owned while 42 reduced positions. 9 funds bought stakes while 21 increased positions. They now own 55.19 million shares or 1.99% less from 56.32 million shares in 2015Q2.
Bvf Inc Il holds 9.06% of its portfolio in Oncothyreon Inc (USA) for 16.36 million shares. Venbio Select Advisor Llc owns 5.51 million shares or 3.92% of their US portfolio. Moreover, Perkins Capital Management Inc has 1.19% invested in the company for 390,650 shares. The California-based Ecor1 Capital Llc has invested 1.18% in the stock. Redmile Group Llc, a California-based fund reported 3.61 million shares.
Analysts await Oncothyreon Inc (USA) (NASDAQ:ONTY) to reports earnings on March, 8. They expect $-0.09 earnings per share, down 12.50% or $0.01 from last year’s $-0.08 per share. After $-0.08 actual earnings per share reported by Oncothyreon Inc (USA) for the previous quarter, Wall Street now forecasts 12.50% negative EPS growth.
My sources say March 8th.
Oncothyreon Inc (NASDAQ:ONTY) Given Average Rating of “Buy” by Brokerages
http://www.financial-market-news.com/oncothyreon-inc-nasdaqonty-given-average-rating-of-buy-by-brokerages/899178/
February 29th, 2016 - By Samantha Reynolds - 0 comments
Oncothyreon logoOncothyreon Inc (NASDAQ:ONTY) has been given a consensus rating of “Buy” by the six analysts that are currently covering the company, AnalystRatingsNetwork.com reports. Two investment analysts have rated the stock with a hold recommendation and four have given a buy recommendation to the company. The average twelve-month target price among brokerages that have covered the stock in the last year is $4.31.
Shares of Oncothyreon (NASDAQ:ONTY) traded down 6.538% during midday trading on Monday, hitting $0.972. The company had a trading volume of 503,788 shares. The company’s market capitalization is $92.27 million. Oncothyreon has a 12 month low of $0.90 and a 12 month high of $4.69. The company has a 50-day moving average of $1.30 and a 200-day moving average of $2.56.
Several equities research analysts have commented on ONTY shares. HC Wainwright reiterated a “buy” rating and set a $5.00 price objective on shares of Oncothyreon in a research note on Wednesday, December 9th. Cantor Fitzgerald reiterated a “hold” rating and set a $3.00 price objective on shares of Oncothyreon in a research note on Monday, January 11th. Jefferies Group reiterated a “buy” rating and set a $5.00 price objective on shares of Oncothyreon in a research note on Wednesday, December 9th. Finally, Zacks Investment Research lowered Oncothyreon from a “buy” rating to a “hold” rating in a research note on Tuesday, November 10th.
Oncothyreon Inc (NASDAQ:ONTY) is a clinical-stage biopharmaceutical company focused primarily on the development of therapeutic products for the treatment of cancer. The Company’s clinical-stage product candidates include ONT-380, an orally active and selective small-molecule HER2 inhibitor, and ONT-10, a therapeutic vaccine targeting the Mucin 1 peptide antigen.
12 Month Chart for NASDAQ:ONTY
wonder why 4th qarter results are not out yet-should have been out in early Feb.
ONTY: Oncothyreon to Present at Cowen and Company 36th Annual Health Care Conference
SEATTLE, March 01, 2016 (GLOBE NEWSWIRE) -- Oncothyreon Inc. (Nasdaq:ONTY) announced today that Julie M. Eastland, President and Chief Financial Officer and Vice President, Corporate Development, is scheduled to present at the Cowen and Company 36(th) Annual Health Care Conference on Tuesday, March 8, 2016 at 8:00 a.m. Eastern Time in New York.
A live and archived webcast of the presentation will be accessible by visiting the Oncothyreon website www.oncothyreon.com under the "News & Events" section.
About Oncothyreon
Oncothyreon is a clinical-stage biopharmaceutical company specializing in the development of innovative therapeutic products for the treatment of cancer. Our goal is to discover, develop and commercialize novel compounds that have the potential to improve the lives and outcomes of cancer patients. Our most advanced product candidate is ONT-380, an orally active and selective small molecule HER2 inhibitor. We are developing preclinical product candidates in oncology and immune-oncology using our protocell technology. For more information, visit www.oncothyreon.com.
CONTACT:
Investor Relations:
Julie Rathbun
Rathbun Communications
206-769-9219
ir@oncothyreon.com
Media Relations:
Kelly France, Ph.D.
BrewLife
415-946-1076
kfrance@brewlife.com
ONCOTHYREON INC., 2601 Fourth Avenue, Suite 500, Seattle, WA 98121
Tel: (206) 801-2100 Fax: (206) 801-2101
http://www.oncothyreon.com
(MORE TO FOLLOW) Dow Jones Newswires
March 01, 2016 08:00 ET (13:00 GMT)
ONTY: Oncothyreon Announces First Patient Dosed in Randomized Phase 2 ONT-380 Combination Trial in Patients with HER2-Positive Breast Cancer
Feb 29, 2016 08:00:00 (ET)
Oncothyreon Announces First Patient Dosed in Randomized Phase 2 ONT-380 Combination Trial in Patients with HER2-Positive Breast Cancer
--Study to Evaluate ONT-380 in Combination with Herceptin and Xeloda--
--Study Will Enroll HER2-Positive Breast Cancer Patients With and Without Brain Metastases--
SEATTLE, Feb. 29, 2016 (GLOBE NEWSWIRE) -- Oncothyreon Inc. (Nasdaq:ONTY), a clinical-stage biopharmaceutical company dedicated to the development of therapeutic products that can improve the lives and outcomes of patients with cancer, today announced dosing of the first patient in a randomized, placebo-controlled Phase 2 trial of ONT-380 in combination with Herceptin(R) (trastuzumab) and Xeloda(R) (capecitabine). ONT-380 is an oral, HER2-selective, central nervous system (CNS)-active tyrosine kinase inhibitor. The trial is enrolling heavily pretreated patients with advanced HER2-positive breast cancer with or without brain metastases.
"There is a great need for effective, well-tolerated treatments for women with progressing metastatic HER2-positive breast cancer, especially those with metastases to the brain, which develops in up to half of these patients and who are frequently excluded from clinical trials. With no approved therapy for the treatment of brain metastases, options for this patient population are currently limited," said Erika Hamilton, M.D., director, Breast and Gynecologic Cancer Research Program, Sarah Cannon Research Institute. "This trial includes specifically designed endpoints around HER2-positive CNS disease to further explore the activity of ONT-380 in combination with Herceptin and Xeloda on brain metastases and the potential to address this unmet medical need."
"Based on data from our Phase 1b studies, which show that the combination of ONT-380 with other active treatments was well tolerated and resulted in objective responses and prolonged, stable disease, we believe that ONT-380 has the potential to be an important new treatment for HER2-positive breast cancer patients, especially for women with brain metastases," said Christopher S. Henney, chairman and interim CEO of Oncothyreon. "We are excited to advance the development of ONT-380 in the third-line metastatic setting with the initiation of this Phase 2 trial. Additionally, we continue to evaluate opportunities for ONT-380 and to establish the most efficient regulatory path forward."
About the Study
The clinical trial is a Phase 2 randomized, double-blind, placebo-controlled study of ONT-380 in combination with Herceptin and Xeloda in patients with pretreated, unresectable locally advanced or metastatic HER2-positive breast cancer. (ClinicalTrials.gov Identifier: NCT02614794) The trial is expected to enroll approximately 180 patients in multiple centers located in the United States, Canada and Western Europe. Patients must have been previously treated with a taxane, Herceptin, Perjeta (pertuzumab) and Kadcyla (ado-trastuzumab emtansine or T-DM1). Patients with or without brain metastases are eligible, including patients with asymptomatic untreated brain metastases not needing immediate local therapy and patients with previously treated brain metastases.
The trial's objectives are to assess the efficacy, safety and pharmacokinetics of ONT-380 in combination with Herceptin and Xeloda. The primary endpoint is progression free survival (PFS) based on assessment of both CNS and non-CNS disease. Additional endpoints include time to CNS progression, objective response rate and overall survival.
About ONT-380
ONT-380 is an oral, CNS-active, reversible and selective small molecule HER2 inhibitor being developed for the treatment of metastatic breast cancer. Unlike other approved and investigational treatments, ONT-380 selectively inhibits HER2 without significant inhibition of EGFR (also called HER1), resulting in highly potent inhibition of HER2 while potentially avoiding the side effects associated with dual inhibitors, including skin rash and gastrointestinal toxicities. In addition, ONT-380 has been shown to have durable, objective responses in HER2-positive patients with brain metastases. Brian metastases impact up to 50 percent of women with HER2-positive metastatic breast cancer and represent a major unmet medical need.
About Oncothyreon
Oncothyreon is a clinical-stage biopharmaceutical company specializing in the development of innovative therapeutic products for the treatment of cancer. Our goal is to discover, develop and commercialize novel compounds that have the potential to improve the lives and outcomes of cancer patients. Our most advanced product candidate is ONT-380, an orally active and selective small molecule HER2 inhibitor. We are developing preclinical product candidates in oncology and immune-oncology using our protocell technology. For more information, visit www.oncothyreon.com.
Forward-Looking Statements
In order to provide Oncothyreon's investors with an understanding of its current results and future prospects, this release contains statements that are forward-looking. Any statements contained in this press release that are not statements of historical fact may be deemed to be forward-looking statements. Words such as "believes," "anticipates," "plans," "expects," "will," "intends," "potential," "possible" and similar expressions are intended to identify forward-looking statements. These forward-looking statements include Oncothyreon's expectations regarding clinical development activities, results of clinical trials and potential benefits of its product candidates.
Forward-looking statements involve risks and uncertainties related to Oncothyreon's business and the general economic environment, many of which are beyond its control. These risks, uncertainties and other factors could cause Oncothyreon's actual results to differ materially from those projected in forward-looking statements, including those predicting the timing, duration and results of clinical trials, the timing and results of regulatory reviews, the safety and efficacy of our product candidates, and the indications for which our product candidates might be developed. There can be no guarantee that the results of preclinical studies or clinical trials will be predictive of either safety or efficacy in future clinical trials. Although Oncothyreon believes that the forward-looking statements contained herein are reasonable, it can give no assurance that its expectations are correct. All forward-looking statements are expressly qualified in their entirety by this cautionary statement. For a detailed description of Oncothyreon's risks and uncertainties, you are encouraged to review the documents filed with the securities regulators in the United States on EDGAR and in Canada on SEDAR. Oncothyreon does not undertake any obligation to publicly update its forward-looking statements based on events or circumstances after the date hereof.
CONTACT:
Investor Relations:
Julie Rathbun
Rathbun Communications
206-769-9219
ir@oncothyreon.com
Media Relations:
Kelly France, Ph.D.
BrewLife
415-946-1076
kfrance@brewlife.com
(MORE TO FOLLOW) Dow Jones Newswires
February 29, 2016 08:00 ET (13:00 GMT)
What a POS this ones turned out to be.
Guess I was wrong.... Bought some cheapies Friday.
I never declared a bottom on ONTY when I posted here earlier this week.
But yes, I still have a start position since yesterday. I may add to it soon. I'm not all in it with full exposure.
But this market has been 'wow' frustrating the last few months.
I think ONTY & LABU have a chance to outperform by end of this month--- call me crazy. In the mean time, hopefully they don't crash. This stock has dipped 3 times since its peak in early November and literally has already been crashing. It's on its 3rd developing leg down now, so it's due up for a reasonably nice spike in my opinion.
If you thought that you must be like wow now.
Looking short term cheap here around 1.27-1.30 area today so far. We may be likely hitting a critically oversold threshold--- at least for the short term in my opinion. Could see a good technical reversal bounce to 1.70-2+ in short term, maybe much more of we get news.
...Not calling it certain at bottom today, but I think we are close.
Seems like a good stock to start considering taking some risk on for short term trade.
Has a decent amount of cash for near term + ONTY has nice amount of positive news catalysts going forward.
Also compare to the sector (S&P biotech) below. I also similarly like LABU showing good signs since Friday.
Also good potential for a good developing short term buy for a trade.
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Wishful thinking. We are screwed here. The bios are broken right now. Just hope I get out with something.
Um, I read the PR lol..
How do u know they did that?
The company left data out of the PR
I hate everyone, wtf
Hope it does. I'm in ARRY who is helping make it
Conference Call this afternoon!
conference call on Tuesday, December 8, 2015 at 4:30 p.m. Eastern Time (1:30 p.m. Pacific) to discuss new clinical data from ongoing clinical trials of ONT-380, an orally active, reversible and selective small-molecule HER2 inhibitor being developed for the treatment of metastatic breast cancer. The data, which include additional and updated clinical trial data on ONT-380 for the treatment of patients with HER2-positive metastatic breast cancer, as well as an analysis of patients who suffer from central nervous system (CNS) metastases, are slated for presentation during the San Antonio Breast Cancer Symposium (SABCS) being held December 8-12, 2015 in San Antonio, TX.
To participate in the call by telephone, please dial (877) 280-7291 (United States) or (707) 287-9361 (International). In addition, the call will be webcast live and can be accessed on the "Events" page of the "News & Events" section of Oncothyreon’s website at www.oncothyreon.com. An archive of the webcast will be available after completion of the discussion and will be posted on the Oncothyreon website.
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company web-site - http://www.oncothyreon.com
recent event / CC - http://ir.oncothyreon.com/events.cfm -
Oncothyreon is a biotechnology company dedicated to the development of oncology products that can improve the lives and outcomes of cancer patients. We are currently developing multiple therapeutic candidates designed to target cancer in specific and effective ways. Our pipeline includes both synthetic vaccines and small molecules for a variety of cancer indications. Oncothyreon is headquartered in Bellevue, Washington. The Company is traded on the NASDAQ National Market under the symbol ONTY and on the Toronto Stock Exchange under the symbol ONY. We are The Cancer Vaccine People(TM).
Stimuvax
ONTY's drug Stimuvax, in partnership with Merck KGaa, is now in large Phase 3 Pivotal Trial program for NSCLC:
Phase III NSCLC (Lung) "START" Trial - http://www.clinicaltrials.gov/ct2/show/NCT00409188
Phase III NSCLC "INSPIRE" Trial (Asia) - http://www.clinicaltrials.gov/ct2/show/NCT01015443
Phase II NSCLC w/Avastin Trial - http://www.clinicaltrials.gov/ct2/show/NCT00828009
Phase I/II NSCLC Trial in Japan - http://www.clinicaltrials.gov/ct2/show/NCT00960115
Phase IV Long-Term Safety Trial - http://www.clinicaltrials.gov/ct2/show/NCT01423760
Phase II HDPC Trial - http://bethesdatrials.cancer.gov/clinical-research/search_detail.aspx?ProtocolID=NCI-11-C-0247
Pipe-Line - http://www.oncothyreon.com/pipeline/overview.html
Remaining Pipe-Line -
ONT-10 - http://www.oncothyreon.com/pipeline/vaccines/ONT-10/overview.html
PX-866 - http://www.oncothyreon.com/pipeline/small/PX-866/overview.html
Start of Trial with Taxotere - http://ir.oncothyreon.com/releasedetail.cfm?ReleaseID=526661
Start of Trial with Erbitux - http://ir.oncothyreon.com/releasedetail.cfm?ReleaseID=537953
PRESS RELEASES
Oncothyreon Initiates Phase 2 Trial of its PI-3 Kinase Inhibitor PX-866 in Patients with Glioblastoma - http://ir.oncothyreon.com/releasedetail.cfm?ReleaseID=561867
Oncothyreon Presents Preclinical Data for ONT-10 and PX-866 at American Association for Cancer Research - http://ir.oncothyreon.com/releasedetail.cfm?ReleaseID=561521
Oncothyreon Announces Publication of Safety & Survival Data From Stimuvax Phase 1/2 NSCLC Trial - http://ir.oncothyreon.com/releasedetail.cfm?ReleaseID=515788
Oncothyreon Initiates Phase 1/2 Trial of its PI-3 Kinase Inhibitor PX-866 in Combination with Cetuximab - http://ir.oncothyreon.com/releasedetail.cfm?ReleaseID=537953
Oncothyreon announces that Merck Serono is resuming the Stimuvax clinical program in lung cancer - http://ir.oncothyreon.com/releasedetail.cfm?ReleaseID=480296
Oncothyreon announces temporary suspension of Stimuvax clinical trials - http://ir.oncothyreon.com/releasedetail.cfm?ReleaseID=453976
Oncothyreon announces STRIDE Phase 3 BC trial - June 22, 2009 http://investorshub.advfn.com/boards/read_msg.aspx?message_id=38926533
Oncothyreon announces clinical data at ASCO - May 30, 2009 - http://investorshub.advfn.com/boards/read_msg.aspx?message_id=38259984
Oncothyreon announces development plans - Dec. 18, 2008 - http://biom.client.shareholder.com/releasedetail.cfm?ReleaseID=355043
Merck KGaA buys manufacturing rights for Stimuvax - Dec. 18, 2008 - http://biom.client.shareholder.com/releasedetail.cfm?ReleaseID=355037
ONTY/Merck KGaA amend agreements - Aug 8, 2007http://www.marketwatch.com/news/story/biomira-merck-kgaa-sign-amended/story.aspx?guid=%7B43FD62A1%2D....
MEDICAL PRESENTATIONS
ASCO 2007 Stimuvax Abstract - http://www.asco.org/ASCOv2/Meetings/Abstracts?&vmview=abst_detail_view&confID=47&abstractID=32165
"16 pts were evaluated for this interim safety analysis ..........As of September 2006, 10 pts were still on study treatment."
ASCO 2008 Stimuvax Abstract - http://www.asco.org/ASCOv2/Meetings/Abstracts?&vmview=abst_detail_view&confID=55&abstractID=34755
"The 2-year survival rate of 64% ....compares favorably with previously reported survival for chemoradiation in stage III NSCLC."
ASCO 2009 Stimuvax Abstract - http://www.abstract.asco.org/AbstView_65_31704.html
"a remarkable # of pts received prolonged treatment...16 pts received L-BLP25 for 2.0-7.7 years, 10 pts were treated for >5 years."
COMPLETE MEDICAL PAPERS
Paper summarizing all Stimuvax trials to date - http://investorshub.advfn.com/boards/read_msg.aspx?message_id=39761211
Publication of Data From Phase 1/2 NSCLC Trial - http://ir.oncothyreon.com/releasedetail.cfm?ReleaseID=515788
A Peptide Vaccine Strategy in NSCLC - http://investorshub.advfn.com/boards/read_msg.aspx?message_id=39627241
Phase IIb Trial in NSCLC Stage IIIB and IV - http://investorshub.advfn.com/boards/read_msg.aspx?message_id=39099793
"The greatest difference in survival was observed in stage IIIB LR patients (adjusted HR = 0.524; 95% CI, 0.261 to 1.052; P = .069)"
- Fig 3. Overall survival by study arm - http://jco.ascopubs.org/cgi/content-nw/full/23/27/6674/F3
- Fig 4. Survival analysis for stage IIIB with MFE or stage IV patients - http://jco.ascopubs.org/cgi/content-nw/full/23/27/6674/F4
- Fig 5. Survival analysis for stage IIIB locoregional patients - http://jco.ascopubs.org/cgi/content-nw/full/23/27/6674/F5
Detailed Description of START Trial - http://investorshub.advfn.com/boards/read_msg.aspx?message_id=39062424
First Interim Look - http://investorshub.advfn.com/boards/read_msg.aspx?message_id=58060227
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