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new corporate presentation posted 4/11
http://www.oncolyticsbiotech.com/wp-content/uploads/2017/04/4_11_17___Oncolytics_Investor_Presentation.pdf
oncy releases p/r for registration pathway:
http://www.newswire.ca/news-releases/oncolytics-biotech-inc-announces-registration-pathway-and-clinical-development-plan-619242384.html
AACR annual meeting poster presentation:
http://finance.yahoo.com/news/oncolytics-biotech-inc-reolysin-more-110000076.html
from 20-f recently released:
https://www.sec.gov/Archives/edgar/data/1129928/000112992817000003/ex151-2016mda.htm
Path #1 - Direct Tumour Lysis
Our first clinical development path focuses on direct tumour lysis and is based on the clinical data from our randomized chemotherapy combination trials. We have demonstrated a strong trend showing a two-year survival benefit in patients with pancreatic cancer in two clinical studies and are planning to take advantage of this survival data and existing orphan drug designations to seek regulatory advice in the U.S. and Europe to establish a clear path to registration in pancreatic cancer.
Path #2 - Innate Immune Response
The second path involves the combination of immune modulatory drugs (IMiDs) with REOLYSIN to enhance the innate immune response against the tumor. We expect to be able to announce collaborations in this path in the second quarter of 2017 that combine REOLYSIN with IMiDS and investigate whether the addition of REOLYSIN can enhance the benefit of this class of agents.
Path #3 - Adaptive Immune Response
Our third clinical development path focuses on the adaptive immune response, a long-term, durable and learned response. This creates a vaccination-like response that, through lysis of the tumor by the virus, educates the body’s immune cells to target and attack unique cancer antigens. We believe that REOLYSIN in combination with checkpoint inhibitors - immunological agents that enhance the adaptive immune response - will act synergistically to provide enhanced overall survival to patients. Early in 2016, we announced that the first patients had been treated in our Phase 1b study of pembrolizumab (KEYTRUDA®) in combination with REOLYSIN and chemotherapy in patients with advanced pancreatic adenocarcinoma. This study is enrolling patients 18 years or older with histologically confirmed advanced or metastatic pancreatic adenocarcinoma who have failed, or did not tolerate, first line treatment. It is an open-label Phase 1b trial designed to determine the safety and dose-limiting toxicities of REOLYSIN® and chemotherapy (gemcitabine or irinotecan or fluorouracil, at the treating physician's preference) in combination with pembrolizumab. Secondary endpoints include overall response rate and progression free survival by immune-related response criteria; overall survival; and effects of REOLYSIN and pembrolizumab when administered in combination as determined by analysis of pre- and post-treatment treatment biopsies and blood-based immune markers. Following an initial six to nine patient safety run-in, up to an additional 15 patients may be enrolled for further evaluation of safety and efficacy.
Our focus will be to work towards product registration via the first path of the clinical development plan. The objectives of paths two and three are to enhance the exposure of REOLYSIN to leading pharmaceutical companies working in immuno-oncology and enhance the market opportunities for our agent; that process is underway.
https://www.sec.gov/Archives/edgar/data/1129928/000112992817000003/ex442thompson.htm
look at docket posts 1548 and 1550.
order allowing unsecured creditors to go after officer and directors via their insurance policy.
QUESTIONABLE BOD ACTION:
On December 11, 2013, the Company issued a warrant for 25,000,000 common shares to Hegyi, LLC, an entity controlled by Marco Hegyi, President of the Company. The warrants have a five-year term with an original exercise price of $0.08 per share. The warrants vest immediately and are exercisable in whole, or in part, at any time and from time to time on or after the issue date and on or before the termination date. The Company valued the warrants at the time of issuance using the Black-Scholes option pricing model using the following assumptions: (i) dividend yield of 0%; (ii) expected volatility of 88.81%; (iii) risk free rate of 0.02% and (iv) an expected term of three years. The Company expensed the entire $1,725,000 at the time of issuance because the warrants vested immediately and were also exercisable immediately.
On January 25, 2016, GrowLife, Inc. (the “Company”) approved a change in the Employment Agreement for Mr. Marco Hegyi, the Company’s President. The change reduced the Warrant price to $0.010 per share. The change was effective December 18, 2015.
so, instead of actually doing something to actually earn a profit from the warrants, the board just reduced the warrants from $.08 to $.01. not exactly what you would call being aligned with shareholder interests!!
until reo is approved, oncy only has the ability to recover direct costs:
regarding the ability to recover "direct costs" the fda had published guidelines:
http://www.fda.gov/BiologicsBloodVaccines/GuidanceComplianceRegulatoryInformation/ProceduresSOPPs/ucm336287.htm
Or is this because of the approved ODDs?
currently oncy does not have any approved odd's. they only have designations. an orphan drug designation is neither an approval nor a guarantee of approval. oncy is currently jumping through the hoops to turn these designations into approvals so hopefully 2016 will be the year of approval(s) for oncy.
Emerging treatments or therapies for cancer and other severe, life-threatening diseases, when:
• Conducted pursuant to an FDA, NIH, NCI, or Cancer-cooperative group approved Phase I, II or
Phase III Clinical Trial. In the event a covered person is not formally a participant in the approved
Clinical Trial, such treatment or therapy must be administered under the direction of a physician,
follow the protocols and procedures utilized in the trial and be delivered at a facility that has been
designated as a participant under the approved FDA, NIH, NCI, or Cancer-cooperative group for
Phase I, II or Phase III Clinical Trial
• Where the illness is encountered so infrequently that no formal trials exist, if the proposed
treatment is considered promising care by knowledgeable experts in the field and is supported by
evidence of efficacy in the peer reviewed literature, such treatment will be allowed when
performed within a facility that actively participates in approved FDA, NIH, NCI, or Cancercooperative
group Phase I, II or Phase III Clinical Trials.
look on page 28 for the reolysin inclusion.
http://www.cwa1298.org/sites/cwa1298d6.prometheuslabor.com/files/2016_att_eligible_former_employee_careplus.pdf
also, go the the first part of the section dealing with these drugs and you will see that although reo requires a preapproval, it is pretty much sop. the only thing is that it must be administered by a physician familiar with the protocols used in the clinical trial setting and must be administered at a site which has performed such trials.
with those exceptions, it seems to be somewhat of a blanket approval for the use of reo in most cancers.
oncolytics currently doing a run-in study for muscle invasive bladder cancer. this would come under the "soft tissue sarcoma" referenced in prior post. currently this is only a clinical trial which it is hoped will progress to a registration study sometime early in 2016. again, interesting that care plus considers the use of reolysin as reimbursable in 2016, again without any marketing approvals currently received.
wonder, since this us a clinical trial study, that care plus is looking at this as an off-label reimbursable item?
if one is in a clinical trial, the cost of the drugs are paid for by the sponsers or just supplied "for free" by the pharma whose drug is being tested. in any case, doesn't seem that it would be something to be reimbursed by an insurance company at this point.
wonder if this points to an early 2016 approval for some indication currently under study by oncolytics?
interesting that care plus is now (as of jan 2016) approving reimbursement for the use of reolysin:
CarePlus - Covered Procedures and Covered Services
Calendar Year 2016
Add:
Pelareorep (Reolysin) as an adjunct to chemotherapy or
radiation therapy for numerous cancers including, but not
limited to:
• Head and neck
• Ovarian
• Soft tissue sarcoma
wonder why since there are currently no marketing approvals? whatever, this is a good sign.
neb, i'm a holder and have been lurking on this site for a long time and enjoy your input. however, dpbe up 100% in a down market on a 3000 share trade valued at %0.60 seems nothing but a manipulation. the transaction fee for that trade was around $7-$10. that was not an astute investment.
anticipating some resolution in the dr. until then, back to lurking.
admiral,
growlife said they were working on how to get off the pink sheets and how to obtain a market maker for the stock. would this be part of that process? thanks.
exempt offering of securities: ????
https://www.sec.gov/Archives/edgar/data/1161582/000116169715000276/0001161697-15-000276-index.htm
new 8k filed
On October 10, 2014, GrowLife, Inc. (the "Company") entered into a Promotion Letter with Joseph Barnes which was effective October 1, 2014 pursuant to which the Company engaged Mr. Barnes as its Senior Vice-President of Business Development from October 1, 2014 on an at will basis. This Promotion Letter supersedes and cancels the Manager Services Agreement with Mr. Barnes dated August 1, 2013.
Per the terms of the Barnes Agreement, Mr. Barnes's compensation is $90,000 on an annual basis. Mr. Barnes received a bonus of $6,500 and is also entitled to receive a quarterly bonus based on growth of the Company's growth margin dollars. Mr. Barnes was granted an option to purchase eight million shares of the Company's Common Stock under the Company's 2011 Stock Incentive Plan at an exercise price on the date of grant. The Shares vest as follows:
i Two million of the Shares will vest immediately;
iv Six million Shares will vest on a monthly basis over a period of three years beginning on the date of grant.
All options will have a five-year life and allow for a cashless exercise. The stock option grant is subject to the terms and conditions of the Company's Stock Incentive Plan, including vesting requirements. In the event that Mr. Barnes's continuous status as employee to the Company is terminated by the Company without Cause or Mr. Barnes terminates his employment with the Company for Good Reason as defined in the Barnes Agreement, in either case upon or within twelve months after a Change in Control as defined in the Company's Stock Incentive, then 100% of the total number of Shares shall immediately become vested.
Mr. Barnes will be entitled to participate in all group employment benefits that are offered by the Company to the Company's senior executives and management employees from time to time, subject to the terms and conditions of such benefit plans, including any eligibility requirements. Finally, Mr. Barnes is entitled to fifteen days of vacation annually and also has certain insurance and travel employment benefits.
Mr. Barnes may receive severance benefits and the Company's obligation under a termination by the Company without Cause or Mr. Barnes terminates his employment for Good Reason are discussed above.
thanx, just got lazy and didn't check out the other areas.
news link gone?
just got on the growlife site and noticed in the navigation bar that the news link was missing. that seems strange, doesn't it?
http://growlifeinc.com/
letter from marco:
apologies if this has already been posted.
https://medium.com/@hegyi/growlife-in-a-state-of-constant-growth-come-unforeseen-challenges-306f57baf575
outlets at new orleans' riverwalk set to open:
http://finance.yahoo.com/news/howard-hughes-corporation-open-outlet-110000684.html
letter to shareholders:
http://online.wsj.com/article/PR-CO-20140313-905880.html
new leasing executives hired:
http://finance.yahoo.com/news/howard-hughes-corporation-expands-retail-120000652.html
4th qtr and full year results:
http://www.sec.gov/Archives/edgar/data/1498828/000110465914014217/a14-6941_1ex99d1.htm
hhc to construct luxury hotel at the woodlands:
http://www.thewoodlandscvb.com/pages/HelpCenter/NewsRoom/tabid/88/EntryID/809/Default.aspx
favorable preliminary tax ruling at summerlin:
http://www.lasvegassun.com/news/2014/feb/21/ruling-favors-hughes-corp-summerlin-land-valuation/
ward's village high rise design inspired by ocean:
http://www.hawaiibusiness.com/Hawaii-Business/February-2014/High-Rises-Design-Inspired-by-the-Ocean/
new tenants coming to summerlin
http://finance.yahoo.com/news/howard-hughes-corporation-announces-fashion-120000262.html
hhc establishes ward village foundation
http://finance.yahoo.com/news/howard-hughes-corporation-establishes-ward-120000936.html
harbor conference presentation:
http://www.sec.gov/Archives/edgar/data/1498828/000110465913010044/a13-5067_1ex99d1.htm
ala moana condo project sold out:
http://www.bizjournals.com/pacific/news/2013/03/05/howard-hughes-corp-expects-to-make.html?ana=yfcpc
hhc receives approval for the redevelopment of south street seaport:
http://finance.yahoo.com/news/howard-hughes-corporation-receives-approval-110000784.html
i put in a buy order today before the market opened for 1k shares at $3.25. almost all of that got filled in the last 20 minutes of trading today including 400 right about the close. figured if someone was playing in 100 share increments that i would at least put in a floor bid with a good number of shares offered to buy.
don't know if this is the bottom or not but i'm happy with my price.
any clue why it was deactivated for a period of about 24 hours?
i was all over the net yesterday with no luck. broker could not answer why the stock was not trading nor why the symbol showed up as invalid. sent an inquiry to the sec and received a canned reply that they got my message and would follow up with a real response, still waiting. also sent an inquiry to aib in ireland with similar question and no response yet. however, i do see that you can at least call up the symbol on yahoo this morning so that leaves me clueless as to what's going on. will be interesting to see if there is any activity at the opening of the markets today.
paulson aquires shares of hhc
http://www.sec.gov/Archives/edgar/data/1035674/000095012311013992/c12592sc13g.htm