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Doc,
thanks but man, if only I had my eltp monies in omer
and vice versa , then I could pat myself on back
eltp will turn suddenly, no hurries then no worrys
concerning paper loss.
Omer,
I will hold at least a year
snup
Well snup, you sure know how to time your buying
GL
Picked up another 2200 , averaging down for me,
when omer quickens it should be fast and furious
short position intriques me, noose around an otherwise
well run company, good pipe line
snup
Your welcome, also posted some info abt progenics on eltp board when it traded around 5 buck,but it was deleted. Up 80% since then
INO also intresting to do some DD
good luck
Doc,
I wish you well, thanks for advise on omer
Snup
Started with 10k at 8.2
Sold at 13.6
And rebought at 11.5
Wish i waited longer
Bought more today at 10.2
Never thought ma50 would break
Hope seller is gone tomorrow
Sold my 10k progenics too this morning right before they took of again
Bad day
Better tomorrow
Doc,
I got 2500 today,
thanks
snup
Its brutal today, you see how hard its gonna be for elite to reach a dollar or 1B dollar market cap
Omer 390mil and dropping
Restested MA50
Should hold imo and go back up
If so, good day to buy your first shares
Insiders had to cash out there options this week because they expire within few days
Bad timing, but isn't it always bad timing?
Short intrest is huge, of the shares not locked up by insiders and institutions 65% is shorted
Once they gonna start covering its gonna be a frenzy
Average price target is $40
Docthor,
I appreciate your wisdom, I assume this
is a good entry for omer? I may buy a couple
of k today for fun. I am adding regarding eltp
as I sincerely believe odds favor something good
regarding next news item we receive. as always
if sequest fails, Andas will kick into gear two
years out so money will be parked but it already
is.
thanks again,
snup
I dont think pfeiffer will do much regarding approval or not, fda gave them a list to work with,if list is cleared so will approval
Regarding lox and dantrelone get us to 40 cent, or 400mil market cap,doubt it.
Omeros has so much more and they trade at 400 mil market cap.
If approved, i'll jump ship 100%
If another crl i buy 50% if it dips to 8cent
GLTU
Doc thor,
starting to do omer dd, I caught some coin from casc yesterday
this is exactly why I do all or none orders and Good till cancelled
orders with eltp
glad omer has been moving up for you last two months.
thanks,
snupdawgoled
Dr. come over to stocktwits and share some of your knowledge. Theres over 2600 omer followers there
to stop this massive number of shorting this stock (25% of O/S or 10 mil shares) ,every investor here should put a sell order at 100 buck,As they are 'on order' they cannot be lent out by your broker and in turn you are reducing the amount of 'free shares' out there that can be used for shorting purposes, then, that way your shares can't be shorted - not much but helps :D.
Although an individual personal investor will not normally have enough shares to halt a concerted shorting attack, if a large number of holders did this it would reduce the overall amount of shares that they could get their hands on.
In my opinion well worth doing if not only for the knowledge that your own shares cannot and will not be used in a short attack against the very share that you own
Omeros (NASDAQ:OMER) Management shared that Omidria's net sales are annualizing north of $55 million in early November, which implies a significant improvement over Q3. I was worried about the growth trends after seeing the stark difference in management remarks in the first and second quarter and especially after the recent pipeline data barrage. And while the company did miss the consensus, it did so just barely and the growth trends in Q4 are really encouraging. However, the pipeline remains the real value driver and getting OMS721 approved in just one of the five targeted indications could unlock significant shareholder value in the following years.
Q3 overview and Q4 2016 and 2017 outlook for Omidria
Omidria sales were up 13% sequentially to $11.3 million (sell-in) and were up 18% on a sell-through basis. The company did miss the analyst consensus by $0.3 million, but sales came near the top of my conservative $8.5-11.5 million range (which I recently revised down from a $10-12 million range). According to CEO Demopulos, there was some seasonal weakness in July and in the first half of August, but growth accelerated in the second half of August and in the following months. September sales showed a 21% increase over June and the company said that Omidria's net sales are annualizing north of $55 million in early November, which translates into around $14 million on a quarterly basis. If we see more growth throughout November and the first half of December (I assume the number of surgeries goes down significantly during the holidays), we could see Q4 sales in the $15-16 million range. Some of the initiatives Omeros has recently initiated are yet to have a significant effect on sales:
• The consignment program was launched in June and the first customers were on board at the end of July. Utilization has increased 50% in those accounts. Utilization across all customers should improve as they sign up for the program. This program alone could add a few million in net sales a quarter in 2017. Assuming we get similar results in the majority of accounts and that 20-30% of accounts sign up in early 2017, revenues could increase by $1.5 million to $2 million a quarter based on the recent annualized run rate of $55 million. This would add $6-8 million in net sales in 2017, or even more if we assume a higher percentage of participants in the program.
• The company did not pursue the hospital opportunity as aggressive as it should because it takes longer to get them on board (getting through the P&T committee). But once a hospital is on board, it tends to stick around and become a regular customer. The company has put more emphasis on this opportunity in Q3 and vials sold to hospitals grew 41% over Q2. The impact on net sales was not as high due to increased discounts to hospitals, but sales have nonetheless increased. Aside from increased stickiness, the company noted another positive long-term impact of hospital penetration - residents. A hospital is a learning hub and once residents leave, they tend to use what they are familiar with. And if they were trained to use Omidria in cataract surgery, they will tend to use it when they move on (especially when they see the many clinical benefits of using Omidria).
• Omeros has ramped up the efforts around Omidria's clinical benefit message and management claims it has led to a nationwide increase in sales. Five manuscripts underscoring the real world benefits of Omidria were recently submitted for publication in peer-reviewed journals (independent studies) and an additional one is in preparation and these publications should have a positive effect on Omidria's uptake in the following quarters. These manuscripts include results from independent studies and ...describe a host of clear clinical advantages of Omidria compared to the use of epinephrine. Reduced complication rates, reduced use of costly and iris-damaging pupil expanding devices, faster surgical times allowing increased patient throughput, greater ease of performing femtosecond laser cases and better visual acuity following surgery, all of these difference meeting statistical significance.
The company's clinical efforts are also focused on the importance of the anti-inflammatory effect of Omidria and not only during surgery but postoperatively (from the Q3 call, emphasis mine):
The message that the ketorolac and Omidria prevent intraoperative pupil constriction and postoperative pain is well understood and accepted. Now, additional data have been generated that further underscore the importance of the anti-inflammatory action of Omidria and experts are proposing that use of Omidria can obviate the need for pre- and postoperative topical NSAID drops in patients undergoing cataract surgery.
These topical drops can be expensive and compliance is always a challenge. We have learned that a letter to the editor is currently in press in the Journal of Ocular Pharmacology and Therapeutics, discussing Omidria versus topical NSAID drops and a full manuscript detailing the data is being finalized for submission.
This could become another major selling point for Omidria and could positively affect uptake in 2017 and beyond.
So, Omeros is not wasting time and is doing everything it can to drive sales higher. Granted, it did not meet this year's objective of getting to a cash flow breakeven point, but the recent growth trends are very positive and cash flow breakeven is not out of reach in late 2017. Sales trends have been volatile and it is hard to predict where quarterly sales will be in 2017, but if Q4 sales are at least $14-15 million, a quarterly run rate north of $20 million seems achievable by Q4 2017. Based on the growth trends since last year's launch, Q1 and Q3 seem like seasonally weak quarters and I assume Q1 2017 sales will be flat or just slightly above or below Q4 sales. A solid increase should occur in Q2 and we should then see a flat or slightly higher Q3, followed by a strong Q4
So, my preliminary 2017 sales estimate is between $64 million and $74 million. The current analyst consensus for 2017 is $91.6 million and I think it needs to come down. The numbers are probably skewed higher because of the highest estimate of $140 million, which seems out of touch with reality.
Omeros' Middle East partner should start selling Omidria in the following weeks. I do not expect much in terms of revenue contribution, but it could be a nice addition in 2017 and beyond. Omidria's 2017 revenues from the Middle East (Omeros' part) will probably be in the low to mid-single digits.
There is still no word on the EU partnership as the company wants to leverage its success in the U.S. to get a better deal in Europe. Since Omidria hasn't really ramped up in a significant way, I do not expect a partnership announcement in the near-term, but this becomes a realistic possibility if/when sales exceed $20-25 million a quarter. Partnerships in other regions are also possible in the 2017/2018 timeframe.
Financial review
Omeros guided for higher R&D spending in Q4 and in 2017 but did not say anything specific. I assume cash expenses will rise to at least $25 million and probably $26-27 million a quarter, or $100-110 million for the FY2017. Based on my revenue estimates, the company should burn around $10 million in Q4 2016 and $26-46 million in 2017, for a total burn rate between $36 million and $56 million over the next five quarters.
At the end of Q3, Omeros had $58.2 million in cash (including restricted cash). The new credit facility has reduced the restricted cash by $5 million and added $3 million to the balance sheet, which means that Omeros had around $56 million in available funds on a proforma basis ($61 million including restricted cash). Based on the high end of my cash burn estimate, the company would have just $2 million left by the end of 2017 (or $7 million including the restricted cash), while it could have around $20 million based on the more optimistic scenario.
Omeros has the option to draw an additional $25 million if it satisfies one of these two conditions: $18 million a quarter in Omidria sales or a market cap exceeding $700 million. The company can draw an additional $20 million if Omidria net sales reach $25 million a quarter or if the market cap is north of $1 billion. Based on my estimates for 2017 sales, Omeros could satisfy the first condition in either Q2 or Q4 2017 (Omidria sales above $18 million) and it could draw the funds even sooner if the share price goes higher in the following months. And we should not forget the $40 million ATM the company has in place and which it could use if the stock heads higher. So, it's certainly not smooth sailing from here, but based on the recent growth trends, I think that the financial situation is quite manageable.
Pipeline update
I covered the recent pipeline developments in several articles and daily updates in the Growth Stock Forum, but some things are worth repeating:
• Omeros announced positive phase 2 data in renal diseases in mid-October. The most promising results were achieved in IgA nephropathy and to some extent in membranous nephropathy. The results were based on just two patients in each indication, but are promising nonetheless. Key efficacy measures (urine albumin to creatinine ratios, or uACRs and change in 24-hour urine protein levels from baseline to the end of treatment) associated with improved renal survival were met with statistical significance in IgA nephropathy (p=0.011 for uACR and p=0.017 for 24-hour urine protein levels) while the combined efficacy effects did not reach statistical significance in membranous nephropathy, but the results were promising. Daily steroid doses in both trials were significantly reduced as well, which is another positive sign. It is estimated that there are around 8,000 IgA patients and more than 3,000 membranous nephropathy patients in the U.S.
• Omeros announced positive data from OMS721 phase 2 trial in patients with hematopoietic stem cell transplant-associated microangiopathy, or HSCT-TMA. Three patients completed treatment and mean TMA markers improved over time. The mean LDH level was cut in half (p<0.01) while mean haptoglobin increased over 1.54 g/L from baseline of 0.33 g/L (barely missing statistical significance, p<0.06,). The mean platelet count increased as much as 57,000/µL from a baseline of 18,000/µL but did not reach statistical significance in this small patient population. There are between 2,000 and 5,000 new HSCT-TMA patients in the U.S. every year.
• Steroid-dependent C3 glomerulopathy is another indication Omeros is targeting. On the Q3 call, the company revealed: "findings from kidney biopsies in one patient demonstrated substantial improvement with markedly reduced renal C3 deposits following treatment with OMS721." The company also noted that this particular patient "is significant as well for the fact that he had accelerated progression of his disease while being treated with Soliris." The incidence of C3 glomerulopathy is double that of aHUS and a large number of patients advance to end-stage renal disease.
The positive results have further validated OMS721's potential in these rare diseases (in addition to aHUS). What is important to note here is that, unlike aHUS, which is dominated by Alexion's Soliris, there are no approved treatments for these other indications, meaning that Omeros will have these markets for itself. Omeros bears are arguing that the company will not be able to take market share from Soliris in aHUS (and as stated in my earlier articles, I disagree), and since there is no competition in these other diseases and given their severity, substantial market penetration is all but certain if OMS721 is approved.
I think that Omeros' pipeline still doesn't receive the credit it deserves. Getting just one of these indications approved translates to significant upside potential in the following years. It is also important to note that Omeros is pursuing accelerated approval in all five OMS721 indications, meaning that they should get approved much faster. We could see OMS721 generating sales as soon as 2018 assuming positive phase 3 data in aHUS. The combined addressable market in the U.S. alone for the three indications mentioned in this article (IgA and membranous nephropathy and HSCT-TMA) is at least $4 billion (assuming a $300,000 a year price tag, which is half the price tag of Soliris) at the low end of the patient number estimates and I believe that market penetration rates will be high considering the lack of treatment options and OMS721's promising efficacy and safety profile.
Aside from OMS721, the company announced positive preclinical data of OMS906 in PNH. A single dose of OMS906 resulted in "sustained ablation of systemic APC (alternative pathway of complement) activity for approximately 16 days… The primate data are consisted with recently reported results from well-established animal models in which OMS906 reduced the incidence and severity of arthritis by 86% (p<0.005) and 90% (p<0.01) respectively and significantly improved the survival of PNH-like red blood cells approximately four-fold better (p=0.029) than did a complement factor 5 (C5) inhibitor." It's still early days for OMS906, but I think it has the potential to threaten Alexion's dominance in PNH.
Omeros also announced some promising phase 2 data in addiction (cocaine and heroin), but we can't actually judge the results without proper quantification.
The OMS824 trial is still on hold. Omeros is waiting for Pfizer's PDE10 inhibitor phase 2 data in Huntington's disease before deciding what to do with OMS824. Pfizer has completed enrollment in its phase 2 study and while there is no specified timeline, I think we should see the data sometime in 2017. Positive data from the Pfizer trial could positively affect Omeros' share price as the company will likely decide to proceed with the OMS824 trial.
And finally, Omeros intends to further expand its pipeline with its GPCR program. The company is advancing preclinical programs on a number of targets (source: Q3 earnings call): triple negative breast cancer, demyelinating diseases such as multiple sclerosis, appetite and eating disorders, osteoporosis and seasonal affective disorder. The company is also encouraged by the progress on GPR174, "a receptor that represents a novel target for enhancing the immune response and a unique approach to immune therapies and cancer." The company expects to share additional information on this program before the end of 2016. It's still very early for all of these preclinical programs to add value in the near-term, but they could eventually become very valuable assets.
Conclusion
While the funding risk is not completely off the table, Omeros has made significant progress with Omidria in Q3 and especially in Q4 and the company seems on its way to achieving cash flow breakeven in late 2017 or in 2018 without additional dilution (or with minimal dilution if the credit facility covenants are not satisfied). Omeros' pipeline remains largely neglected and the wealth of positive data the company reported recently is far from being fully appreciated. I remain a long-term Omeros bull and am encouraged by recent developments on both the commercial and product development side.
Author's note: Growth Stock Forum subscribers had an early look at this article, and have access to regular exclusive updates on every stock I am covering. Readers are invited to take a two-week free trial in the Seeking Alpha Marketplace.
Article written by
oneil trader from stock growth forum
still 10mil shares shorted,with price up 65 percent from its low last week,they gonna need to start cover before facing heavy losses
RSI entering the powerzone
if we keep this momentum we could test new HOY next few weeks
--Omeros now required to maintain no more than $5 million in cash and cash equivalents during the full term of the facility. With its initial draw of the CRG loan, together with funds on hand and current annualized OMIDRIA revenues and expenses, Omeros anticipates that it has at least 12 months of operating capital. ---
3 positive trial outcomes in a week time and price dident realy move.
this is poised for a breakout with short intrest need !! 38 !! days to cover
once they start covering its gonna be a buying frenzy
average price target of 40 dollar with a Spread / Highest target of 836% upside potential
RSI80% sits at 17 dollar
lots of room to run
If not for current market this would have been rewarded with significant increase in share price but quality wins out eventually.
I will buy on any pullback. Go listen to the webcast from April 13 at omeros.com under events. Great pipeline and Omidria will make the company cash flow positive later this year.
$OMER recent 58% gain from Jan low may meet hard wall to crack and roll back some of the gains Beware of low volume n take opposite side now
$OMER recent news/filings
bullish 15.95
## source: finance.yahoo.com
Mon, 30 Nov 2015 20:35:12 GMT ~ Omeros CEO: For biotechs, better to be a jack of all trades than a master of one
read full: http://www.bizjournals.com/seattle/blog/health-care-inc/2015/11/omeros-ceo-for-biotechs-better-to-be-a-jack-of-all.html?ana=yahoo
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Wed, 25 Nov 2015 19:24:32 GMT ~ Do Hedge Funds Love Omeros Corporation (OMER)?
read full: http://www.insidermonkey.com/blog/do-hedge-funds-love-omeros-corporation-omer-389150/
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Thu, 19 Nov 2015 20:05:48 GMT ~ 9 IPOs That Fell Flat On Wall Street
read full: http://finance.yahoo.com/news/9-ipos-fell-flat-wall-200548856.html
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Thu, 19 Nov 2015 13:55:00 GMT ~ The Price Data Tells the Story - Research on Omeros, Fidelity Southern, Quotient Technology and RetailMeNot
[Accesswire] - N EW YORK , NY / ACCESSWIRE / November 19, 2015 / Moments ago, Trader's Choice released new research updates concerning several important developing situations including the following equities: Omeros ...
read full: http://finance.yahoo.com/news/price-data-tells-story-research-135500419.html
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Tue, 17 Nov 2015 18:04:32 GMT ~ OMEROS CORP Financials
read full: http://finance.yahoo.com/q/is?s=omer
*********************************************************
$OMER charts
basic chart ## source: stockcharts.com
basic chart ## source: stockscores.com
big daily chart ## source: stockcharts.com
big weekly chart ## source: stockcharts.com
$OMER company information
## source: otcmarkets.com
Link: http://www.otcmarkets.com/stock/OMER/company-info
Ticker: $OMER
OTC Market Place: Not Available
CIK code: not found
Company name: Omeros Corp.
Incorporated In: WA, USA
Business Description:
$OMER share structure
## source: otcmarkets.com
Market Value: Not Available
Shares Outstanding: Not Available
Float: Not Available
Authorized Shares: Not Available
Par Value: No Par Value
$OMER extra dd links
Company name: Omeros Corp.
## STOCK DETAILS ##
After Hours Quote (nasdaq.com): http://www.nasdaq.com/symbol/OMER/after-hours
Option Chain (nasdaq.com): http://www.nasdaq.com/symbol/OMER/option-chain
Historical Prices (yahoo.com): http://finance.yahoo.com/q/hp?s=OMER+Historical+Prices
Company Profile (yahoo.com): http://finance.yahoo.com/q/pr?s=OMER+Profile
Industry (yahoo.com): http://finance.yahoo.com/q/in?s=OMER+Industry
## COMPANY NEWS ##
Market Stream (nasdaq.com): http://www.nasdaq.com/symbol/OMER/stream
Latest news (otcmarkets.com): http://www.otcmarkets.com/stock/OMER/news - http://finance.yahoo.com/q/h?s=OMER+Headlines
## STOCK ANALYSIS ##
Analyst Research (nasdaq.com): http://www.nasdaq.com/symbol/OMER/analyst-research
Guru Analysis (nasdaq.com): http://www.nasdaq.com/symbol/OMER/guru-analysis
Stock Report (nasdaq.com): http://www.nasdaq.com/symbol/OMER/stock-report
Competitors (nasdaq.com): http://www.nasdaq.com/symbol/OMER/competitors
Stock Consultant (nasdaq.com): http://www.nasdaq.com/symbol/OMER/stock-consultant
Stock Comparison (nasdaq.com): http://www.nasdaq.com/symbol/OMER/stock-comparison
Investopedia (investopedia.com): http://www.investopedia.com/markets/stocks/OMER/?wa=0
Research Reports (otcmarkets.com): http://www.otcmarkets.com/stock/OMER/research
Basic Tech. Analysis (yahoo.com): http://finance.yahoo.com/q/ta?s=OMER+Basic+Tech.+Analysis
Barchart (barchart.com): http://www.barchart.com/quotes/stocks/OMER
DTCC (dtcc.com): http://search2.dtcc.com/?q=Omeros+Corp.&x=10&y=8&sp_p=all&sp_f=ISO-8859-1
Spoke company information (spoke.com): http://www.spoke.com/search?utf8=%E2%9C%93&q=Omeros+Corp.
Corporation WIKI (corporationwiki.com): http://www.corporationwiki.com/search/results?term=Omeros+Corp.&x=0&y=0
## FUNDAMENTALS ##
Call Transcripts (nasdaq.com): http://www.nasdaq.com/symbol/OMER/call-transcripts
Annual Report (companyspotlight.com): http://www.companyspotlight.com/library/companies/keyword/OMER
Income Statement (nasdaq.com): http://www.nasdaq.com/symbol/OMER/financials?query=income-statement
Revenue/EPS (nasdaq.com): http://www.nasdaq.com/symbol/OMER/revenue-eps
SEC Filings (nasdaq.com): http://www.nasdaq.com/symbol/OMER/sec-filings
Latest filings (otcmarkets.com): http://www.otcmarkets.com/stock/OMER/filings
Latest financials (otcmarkets.com): http://www.otcmarkets.com/stock/OMER/financials
Short Interest (nasdaq.com): http://www.nasdaq.com/symbol/OMER/short-interest
Dividend History (nasdaq.com): http://www.nasdaq.com/symbol/OMER/dividend-history
RegSho (regsho.com): http://www.regsho.com/tools/symbol_stats.php?sym=OMER&search=search
OTC Short Report (otcshortreport.com): http://otcshortreport.com/index.php?index=OMER
Short Sales (otcmarkets.com): http://www.otcmarkets.com/stock/OMER/short-sales
Key Statistics (yahoo.com): http://finance.yahoo.com/q/ks?s=OMER+Key+Statistics
Insider Roster (yahoo.com): http://finance.yahoo.com/q/ir?s=OMER+Insider+Roster
Income Statement (yahoo.com): http://finance.yahoo.com/q/is?s=OMER
Balance Sheet (yahoo.com): http://finance.yahoo.com/q/bs?s=OMER
Cash Flow (yahoo.com): http://finance.yahoo.com/q/cf?s=OMER+Cash+Flow&annual
## HOLDINGS ##
Major holdings (cnbc.com): http://data.cnbc.com/quotes/OMER/tab/8.1
Insider transactions (yahoo.com): http://finance.yahoo.com/q/it?s=OMER+Insider+Transactions
Insider transactions (secform4.com): http://www.secform4.com/insider-trading/OMER.htm
Insider transactions (insidercrow.com): http://www.insidercow.com/history/company.jsp?company=OMER
Ownership Summary (nasdaq.com): http://www.nasdaq.com/symbol/OMER/ownership-summary
Institutional Holdings (nasdaq.com): http://www.nasdaq.com/symbol/OMER/institutional-holdings
Insiders (SEC Form 4) (nasdaq.com): http://www.nasdaq.com/symbol/OMER/insider-trades
Insider Disclosure (otcmarkets.com): http://www.otcmarkets.com/stock/OMER/insider-transactions
## SOCIAL MEDIA AND OTHER VARIOUS SOURCES ##
PST (pennystocktweets.com): http://www.pennystocktweets.com/stocks/profile/OMER
Market Watch (marketwatch.com): http://www.marketwatch.com/investing/stock/OMER
Bloomberg (bloomberg.com): http://www.bloomberg.com/quote/OMER:US
Morningstar (morningstar.com): http://quotes.morningstar.com/stock/s?t=OMER
Bussinessweek (businessweek.com): http://investing.businessweek.com/research/stocks/snapshot/snapshot_article.asp?ticker=OMER
$OMER DD Notes ~ http://www.ddnotesmaker.com/OMER
* * $OMER Video Chart 08-18-15 * *
Link to Video - click here to watch the technical chart video
lol I was getting umcomfortable when it reached $30 saw for a few minutes was going down disposd it off at right time looks like and no bounce too from the $23 levels again - So glad I did not get in too again
Nice...it's almost back to LOD now.
Right on the money.
Thanks OMER In 23.11 and out low $29s for a 6K gain Again - apart from PBMD OHRP last week Thank you Guys or shall I say stocks
Boom there's $30!
It looks like it hit its high already
I'm done with it unless we see $20-$21
I missed it. Oh well I'm not chasing
Yeah in pre market then up a buck after? lol dang
Omeros Announces Additional Positive Data in OMS721 Phase 2 Clinical Trial
Source: PR Newswire (US)
SEATTLE, Aug. 18, 2015 /PRNewswire/ -- Omeros Corporation (NASDAQ: OMER) today announced additional positive data in the company's Phase 2 clinical trial of OMS721 for the treatment of thrombotic microangiopathies (TMAs). TMAs are a family of rare, debilitating and life-threatening disorders characterized by excessive thrombi (clots) – aggregations of platelets – in the microcirculation of the body's organs, most commonly the kidney and brain. OMS721 is Omeros' lead human monoclonal antibody in its mannan-binding lectin-associated serine protease-2 (MASP-2) program for the treatment of TMAs, including atypical hemolytic uremic syndrome (aHUS).
The Phase 2 trial is designed to enroll primarily aHUS patients but can also enroll patients with thrombotic thrombocytopenic purpura (TTP) and hematopoietic stem cell transplant (HSCT)-related TMA. The trial has fully enrolled the first and second cohorts and is currently completing the third and final planned cohort of its dose-ranging stage. In each three-patient cohort, OMS721 is dosed for four weeks. Data from the first (low-dose) cohort were released on February 19, 2015. Today the company is releasing data from its second (mid-dose) cohort and data to date from its third (high-dose) cohort.
Three patients were treated in the second or mid-dose cohort, two of whom have aHUS and one with TTP. Both patients with aHUS were on renal dialysis prior to and at the time of study enrollment. Based on the positive data from the mid-dose cohort, the high-dose cohort was initiated and an aHUS patient has already completed the study treatment period. No patient with HSCT-related TMA has yet completed dosing with OMS721. The data referenced for all patients include measures to one week following the last dose.
A rare and devastating family of disorders, TMAs are characterized by thrombi or clumps of aggregated platelets in small blood vessels, which lead to thrombocytopenia (below-normal platelet counts) and schistocytes (fragmentation in red blood cells) that can cause dangerously low oxygen levels in organs like the brain and kidney as well as anemia. Thrombotic microangiopathies are life-threatening and can occur both in children and adults. While thrombi, thrombocytopenia and schistocytes are hallmarks of TMAs, other markers of damage within the blood vessels include an elevated plasma lactate dehydrogenase (LDH) and undetectable or reduced plasma haptoglobin levels. In addition, an elevated creatinine level – a result of the kidney damage caused by thrombi – is an indicator of impaired kidney function in patients who are not on renal dialysis.
As in Alexion's clinical trials supporting both U.S. and European regulatory approval of Soliris® for the treatment of aHUS, this Phase 2 clinical trial, given the life-threatening nature of the disease, has no placebo arm. Soliris trials used change from baseline in platelet count as a primary endpoint to obtain approval for the treatment of aHUS. Similarly, the pre-specified primary endpoint in this Phase 2 trial is change from baseline in platelet count. In this trial, platelet counts in all three aHUS patients in the mid- and high-dose cohorts (two in the mid-dose and one in the high-dose cohort) were normal after the treatment period, with a statistically significant mean increase from baseline of approximately 68,000 platelets/mL (p = 0.0055).
Found this by reading this article...
"TLSR: Back in January, you chose four companies to be on The Life Sciences Report Watchlist 2014 (Watchlist Portfolio Tracker) (article). Your picks are Omeros Corp. (OMER:NASDAQ), CytoSorbents Corp. (CTSO:OTCBB), Cerus Corp. (CERS:NASDAQ) and OncoGenex Pharmaceuticals Inc. (OGXI:NASDAQ). Obviously, you think they're all going to appreciate in value this year, but are there other common threads?
GZ: Yes, there are. First, I wanted to give examples of hidden gems-companies that are overlooked by the Street. I wanted to highlight some companies outside of what are considered the popular, hot therapeutic areas of focus, including oncology, antivirals, obesity and diabetes. I wanted to show investors that they don't need to be followers and prompt them to look beyond everybody else's focus.
Second, I wanted to highlight companies that have interesting technologies-unique perhaps, not necessarily with huge blockbuster potential, but certainly very profitable in proportion to the size of the company, and therefore very good for the stock. Finally, you will find sound management in these companies, and good use of capital resources. I also look for companies who raise capital on favorable terms-not toxic deals. That's another common thread.
TLSR: Just focusing on the Watchlist 2014 companies for the moment, could you highlight the important features?
GZ: Of course. I'll start with Omeros, which has a number of features that I find interesting. First is the near-term approval of a niche product called Omidria (phenylephrine + ketorolac). The phenylephrine is a mydriatic (pupil-dilating) agent, and the ketorolac is an anti-inflammatory. The Omidria combination is an irrigant for use in intraocular lens replacement surgery to reduce inflammation and postoperative pain. Maintaining a dilated pupil is important, to maintain an open surgical field to maximize efficiency of the procedure and reduce complications. Patients like the anti-inflammatory agent since it significantly reduces post-operative pain.
Both molecules have long been in the public domain as generics, but I had the opportunity to speak to an ophthalmic surgeon who said that based on emerging trends in the field-specifically the off-label use of generic phenylephrine or epinephrine to maintain pupil dilation and regulatory issues that discourage compounding of generics by pharmacies-he would use this product. This is a procedure he performs hundreds of times each year. We think this is a low-cost, high margin and volume product that could generate about $100 million ($100M) in sales in 2016-not much by big pharma standards, but possibly enough to bring Omeros to profitability that same year.
TLSR: You mentioned a near-term approval. What's the timeline here?
GZ: The new drug application (NDA) for Omidria was filed back in the summer, and after that a marketing authorization application was filed with the European Medicines Agency (NYSEMKT:EMA). Omeros reported that both applications were accepted for review by the agencies in Q3/13, so we expect a decision after the standard 10-month review-probably midyear or early Q3/14 for the FDA-with launch sometime before the end of 2014.
Behind Omidria, there's a robust pipeline that the company has advanced into a number of phase 1 and phase 2 trials. These are unique products that could be first-in-class for a number of interesting indications, including some central nervous system (NYSE:CNS) and inflammatory indications.
TLSR: There is more in the pipeline at Omeros than just old drugs in new packages. You mentioned CNS disease, and I note there are programs in development for cognitive and neuropsychiatric disorders. Do you see this company's business model as one of taking older products and reformulating them to quickly fund the rest of the pipeline?
GZ: That's the rationale behind Omidria-an elegant, rapid path to market for a new formulation of generics that is an attractive and simple solution for an underserved market. Revenue and profits expected in 2016 will serve to fund the backup pipeline. But Omeros may need to do a capital raise in the interim to build out a sales force, because it is planning to sell Omidria on its own."
http://seekingalpha.com/instablog/1256651-life-sciences-report/2733853-shining-a-light-on-overlooked-and-underfollowed-biotechs-george-zavoico
The guy obviously made a good call...
:)
BINGO for the size, now when to verify it's Baker Bros:(logic no other
current instl holder has the portfolio strategy, let alone profile to do this IMHO and I'm not a wizard!). With the net proceeds from this closing
OMER can now put the foot on the gas pedal to a lot of it's pipeline for catalysts AND perhaps be close to self financing after 2015!
Omeros Prices $75 Million Public Offering of Common Stock and Pre-Funded Warrants
Thu January 29, 2015 8:32 AM|PR Newswire | About: OMER
SEATTLE, Jan. 29, 2015 /PRNewswire/ --Omeros Corporation (OMER) today announced that it has priced an underwritten public offering of 2,995,506 shares of its common stock at a per share price to the public equal to $20.03, and pre-funded warrants to purchase up to 749,250 shares of its common stock, at a per warrant price to the public equal to $20.02. The pre-funded warrants have a term of seven years and an exercise price of $0.01 per share. Total gross proceeds, including the approximately $15 million to be received on the pre-funded warrants, will be approximately $75 million. The net proceeds from this offering, after deducting the underwriters' discounts and other estimated offering expenses, will be approximately $70.6 million. Omeros has also granted the underwriters a 30-day option to purchase up to an additional 449,325 shares of common stock to cover overallotments, if any, which would result in additional gross proceeds of approximately $9 million if exercised in full. The offering is expected to close on or about February 3, 2015, subject to customary closing conditions.
AH SEC 424b5 Filing w/Cowen as sole underwriter (NO TERMS!)
Special Note: Altho I've never posted on this board, I've owned OMER since it was $4 April 2013.For credibility: I recall Greg our CEO giving the insurance proceeds of a patent infringement suit to OMER to induce short covering and giving OMER more mos before financing; Greg's building of his Mercer Island home pledging as collateral all his OMER shrs when the stock was in the single digits!
What I find especially interesting in a quick perusal of the above:
Despite having the below:
Outstanding Shares
The number of shares of our common stock to be outstanding immediately after this offering is based on 34,181,332 shares outstanding as of December 31, 2014, and excludes as of that date:
*8,364,469 shares of common stock issuable upon the exercise of outstanding stock options with a weighted-average exercise price of $7.52 per share;Why aren't holders exercising for OMER funding?That's $60 mln!
*551,435 shares of common stock issuable upon the exercise of outstanding warrants with a weighted-average exercise price of $25.06 per share; and
*238,836 shares of common stock available for future grants under our 2008 Equity Incentive Plan (which number increased to 1,948,109 on January 1, 2015 pursuant to the terms of the 2008 Equity Incentive Plan)
We also are offering warrants at the same price of this offering to purchase up to shares of our common stock to certain investors whose purchase of shares of common stock in this offering would result in the purchaser, together with its affiliates and certain related parties, beneficially owning more than 4.99% of our outstanding common stock following the consummation of this offering. We refer to these warrants as pre-funded warrants.
Final post on OMER
http://investor.omeros.com/phoenix.zhtml?c=219263&p=irol-sec
No longer a holder had a very good run for almost 2 yrs. Not that I think OMER can not continue, however, playing the percentages I have put myself "all-in" in a promising bio in the I/O immuno oncology field. Think Bavituximab.....Good luck.
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http://www.omeros.com/
http://finance.yahoo.com/q/ks?s=OMER+Key+Statistics
Omeros is a Seattle-based biopharmaceutical company committed to discovering, developing, and commercializing small-molecule and protein therapeutics for large-market as well as orphan indications targeting inflammation, coagulopathies, and disorders of the central nervous system. Our most advanced product candidates are derived from our proprietary PharmacoSurgery® platform designed to improve clinical outcomes of patients undergoing ophthalmological, arthroscopic, urological and other surgical and medical procedures. Our PharmacoSurgery platform is based on low-dose combinations of therapeutic agents delivered directly to the surgical site throughout the duration of the procedure to inhibit preemptively inflammation and other problems caused by surgical trauma and to provide clinical benefits both during and after surgery. Omidria™ (phenylephrine and ketorolac injection) 1%/0.3%, the first commercial product from Omeros’ PharmacoSurgery platform, was approved by the FDA in May 2014. Omidria is also currently under review for marketing approval by the European Medicines Agency (EMA). Omeros’ six other clinical programs are focused on schizophrenia, Huntington’s disease, and cognitive impairment; addictive and compulsive disorders; complement-related diseases; and preventing problems associated with surgical procedures. Two additional programs are expected to advance into the clinic next year – one for the control of blood loss during surgery or resulting from trauma and the second for the treatment of a wide range of addictions and compulsions as well as any movement disorder. Omeros also has a proprietary GPCR platform, which is making available an unprecedented number of new GPCR drug targets and corresponding compounds to the pharmaceutical industry for drug development. | ![]() |
Omeros is developing a deep pipeline of small-molecule and protein therapeutic candidates targeting inflammation, coagulopathies, and disorders of the central nervous system. Our twelve programs include those focused on inflammation, coagulopathies, and multiple CNS disorders, as well as our three platform programs: PharmacoSurgery®, antibody and G protein-coupled receptor all targeting both large-market and exciting orphan opportunities. Products from our proprietary PharmacoSurgery platform, which yielded our first commercial product Omidria™ (phenylephrine and ketorolac injection) 1%/0.3%, for use during cataract surgery and other lens replacement procedures, are designed to improve the clinical outcomes of patients undergoing arthroscopic, urological, and other surgical and medical procedures. Our MASP program is in clinical development to treat thrombotic microangiopathies, including atypical hemolytic uremic syndrome, and a wide range of inflammatory disorders. Our two PDE10 clinical programs for the treatment of schizophrenia and Huntington's disease, our clinical program for the treatment and prevention of addictions and compulsions and our preclinical programs targeting other CNS disorders and coagulopathies further strengthen our pipeline and help create multiple opportunities for commercial success. Our GPCR platform is making available an unprecedented number of new GPCR drug targets and corresponding compounds to the pharmaceutical industry for drug development, and our antibody platform enables the discovery of novel, high-affinity monoclonal antibodies. For each of our product candidates and programs, we have retained all manufacturing, marketing and distribution rights. | ![]() | |
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Our proprietary PharmacoSurgery® products are designed to improve the clinical outcomes of patients undergoing ophthalmological, arthroscopic, urological and other surgical and medical procedures. Omidria™ (phenylephrine and ketorolac injection) 1%/0.3%, is the first approved drug from our PharmacoSurgery platform |
![]() | We have multiple programs focused on central nervous system (CNS) disorders, all targeting large markets. Our most advanced CNS programs include our phosphodiesterase 10 (PDE10) program, focused on developing drugs for the treatment of schizophrenia, Huntington's disease and other cognitive disorders; our PPARγ program, focused on developing proprietary compositions that include peroxisome proliferator-activated receptor gamma (PPARγ) agonists for the treatment and prevention of addiction to substances of abuse (e.g., opioids, nicotine and alcohol); and our PDE7 program for the development of drugs for the treatment of movement disorders, such as Parkinson's d |
![]() | We are developing antifibrinolytic agents for the control of blood loss during surgery or resulting from trauma. Excessive bleeding during cardiac surgery is known to increase overall morbidity and mortality. In an attempt to control this bleeding, patients undergoing cardiac and other extensive surgery often receive antifibrinolytic compounds. These drugs inhibit plasmin, an enzyme present in blood that degrades fibrin clots. Because plasmin degrades fibrin clots, an agent that inhibits plasmin may have potential utility for reducing blood loss due to trauma or surgery. Prior to withdrawal from the market in 2008 for safety concerns, the antifibrinolytic Trasylol® (aprotinin) had been shown in a number of studies to be more effective at reducing blood loss than the other two most commonly used antifibrinolytics on the market today, tranexamic acid and epsilon aminocaproic acid. While Trasylol® is a potent inhibitor of plasmin, it is non-selective. In addition to plasmin, it significantly inhibits kallikrein and Factor XIa, two enzymes important in promoting clotting, and their inhibition can increase bleeding. Trasylol® was found to be associated with a number of safety issues, including increased mortality. Further, it is a bovine protein associated with anaphylactic reactions. While the specific cause of increased death remains unknown, an often-cited explanation is the lack of specificity of Trasylol®. Our proprietary agents also inhibit plasmin but, unlike Trasylol®, they do not significantly inhibit kallikrein and Factor XIa. Additionally, our agents are derived from human protein, which may reduce immunological side effects. The properties of our proprietary agents are described in a peer-reviewed article titled "Engineering Kunitz Domain 1 (KD1) of Human Tissue Factor Pathway Inhibitor-2 to Selectively Inhibit Fibrinolysis: Properties of KD1-L17R Variant" that was published in the February 11, 2011 issue of the Journal of Biological Chemistry. We believe the efficacy and improved selectivity of our proprietary agents provide a novel approach to the control of bleeding from surgery and trauma. We have selected a lead clinical candidate and are manufacturing pre-clinical supplies to enable the initiation of GLP toxicology studies intended to support the submission of an IND or clinical trial application and subsequent clinical trials. We plan to be in clinical trials with our anti-plasmin molecule in 2015. Patent Position As of February 15, 2014, we owned one issued patent and three pending patent applications in the U.S. and seven issued patents and 26 pending patent applications in foreign markets directed to our recent discoveries linking PPAR? and |
![]() | G protein-coupled receptors (GPCRs), which mediate key physiological processes in the body, are one of the most valuable families of drug targets. According to Insight Pharma Reports, GPCR-targeting drugs represent 30 to 40 percent of marketed pharmaceuticals. Examples include Claritin® (allergy), Zantac® (ulcers and reflux), OxyContin® (pain), Lopressor® (high blood pressure), Imitrex® (migraine headache), Reglan® (nausea) and Abilify® (schizophrenia, bipolar disease and depression) as well as all other antihistamines, opioids, alpha and beta blockers, serotonergics and dopaminergics. The industry focuses its GPCR drug discovery efforts mostly on non-sensory GPCRs. Of the 363 total non-sensory GPCRs, approximately 240 have known ligands (molecules that bind the receptors) with nearly half of those targeted either by marketed drugs (46 GPCRs) or by drugs in development (about 70 GPCRs). There are approximately 120 GPCRs with no known ligands, which are termed "orphan GPCRs." Without a known ligand, drug development for a given receptor is extremely difficult. Omeros uses its proprietary high-throughput cellular redistribution assay (CRA) to identify small-molecule agonists and antagonists for orphan GPCRs, unlocking them to drug development. Omeros believes that it is the first to possess the capability to unlock orphan GPCRs in high-throughput, and that currently there is no other comparable technology. Unlocking these receptors could lead to the development of drugs that act at these new targets. There is a broad range of indications linked to orphan GPCRs including cardiovascular disease, asthma, diabetes, pain, obesity, Alzheimer's disease, Parkinson's disease, multiple sclerosis, schizophrenia, learning and cognitive disorders, autism, osteoporosis, osteoarthritis and several forms of cancer. Omeros has begun screening orphan GPCRs against its small-molecule chemical libraries using its proprietary, high-throughput CRA. In addition to Class A orphan GPCRs, we have also begun screening orphan and non-orphan Class B receptors. Class B GPCRs have large extracellular domains and their natural ligands are generally large peptides, making the development of orally active, small-molecule drugs against these receptors, such as glucagon and parathyroid hormone, a persistent challenge. Omeros has announced that it has identified and confirmed sets of compounds that interact selectively with the following orphan receptors: | ![]() | ![]() | ![]() | The GPCR family represents an important source of drug discovery. Of the 363 characterized GPCRs, only about 46 are currently targeted by marketed drugs, yet GPCR-targeted drugs account for 30-40% of all drugs sold worldwide. | ||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||
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![]() | In parallel, Omeros is executing on its intellectual property strategy to protect each unlocked target through a multipronged approach directed to compound structures, uniquely identified signaling pathways and associated therapeutic indications. Collectively, this approach provides Omeros the opportunity to establish broad and enforceable protection for each unlocked receptor. GPR17We are optimizing compounds against GPR17, a G protein-coupled receptor (GPCR) which is linked to myelin formation. Myelin is an insulating layer rich in lipids and proteins that forms a sheath around the nerve fibers, which is essential for the proper functioning of the nervous system. Loss of the myelin sheath is the hallmark of several diseases, including multiple sclerosis, acute disseminated encephalomyelitis, Neuromyelitis Optica, transverse myelitis, chronic inflammatory demyelinating polyneuropathy, Guillain-Barré syndrome, central pontine myelinosis, inherited demyelinating diseases such as leukodystrophy, and Charcot-Marie-Tooth disease. We believe GPR17 inhibitors have the potential to promote remyelination and improve the outcome of these diseases as well as traumatic brain injury and spinal cord injury, conditions that have been associated with GPR17. Discovering GPR17 inhibitors has previously been challenging to the pharmaceutical industry because this receptor is an orphan GPCR. However, using our proprietary CRA, we have been able to identify over 100 compounds that functionally interact with GPR17. We are now in the process of developing lead molecules targeting GPR17, which we intend to evaluate in remyelination assays in cell culture systems as well as in animal models. | ||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||
![]() | Patent Position As of February 15, 2014, we owned five issued patents and 10 pending patent applications in the U.S., and 43 issued patents and eight pending patent applications in foreign markets , which are directed to previously unknown links between specific molecular targets in the brain and a series of CNS disorders, our cellular redistribution assay and other research tools that are used in our GPCR program and to orphan GPCRs and other GPCRs for which we have identified functionally interacting compounds using our cellular redistribution as |
![]() | Our proprietary ex vivo platform for the discovery of novel, high-affinity monoclonal antibodies utilizes a chicken B-cell lymphoma cell line and has demonstrated potential for the generation of diverse antibodies that can be readily engineered. This platform offers several advantages over other antibody platforms. The ex vivo immunizations of our proprietary cell line are significantly more rapid than whole animal immunizations and conventional hybridoma technology. By avoiding immunization of mice or other animals, we believe that the antibodies we generate from this platform are not limited by immunological tolerance. Our platform is capable of producing novel antibodies against difficult targets, such as highly homologous proteins, enzymes, and receptors with short extracellular domains. Chicken antibodies also have unique features that enable binding capabilities distinct from mammalian antibodies. We have generated antibodies to several clinically significant targets, and our platform continues to add antibodies against additional important targets to our pipeline. Patent Position As of February 15, 2014, we owned and/or held worldwide exclusive license rights from the University of Washington to three pending U.S. Patent Applications, four foreign patent applications and one International Patent Cooperation Treaty Patent Application directed to our antibody platform. Additionally, we owned one issued U.S. Patent, two pending U.S. Patent Applications and eight pending foreign applications directed to antibodies generated |
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