Omeros to Present at the Wedbush PacGrow 2014 Life Sciences Management Access Conference
SEATTLE, Aug. 8, 2014 /PRNewswire/ -- Omeros Corporation (NASDAQ: OMER), a biopharmaceutical company committed to discovering, developing and commercializing products focused on inflammation, bleeding and disorders of the central nervous system, today announced that Gregory A. Demopulos, M.D., chairman and chief executive officer, will present at the Wedbush PacGrow 2014 Life Sciences Management Access Conference in New York next week. The presentation is scheduled for Tuesday, August 12 at 12:45pm EDT.
The presentation will be webcast. The live and archived webcasts can be accessed on the "Events" page of the Company's website.
Omeros Corporation Reports Second Quarter 2014 Financial Results
Mon August 11, 2014 4:03 PM|PR Newswire | About: OMER
SEATTLE, Aug. 11, 2014 /PRNewswire/ -- Omeros Corporation (OMER), a 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, today announced financial results and highlights for the second quarter of 2014, which include:
2Q 2014 net loss of $18.0 million, or $0.53 per share, which included $2.5 million ($0.07 per share) of non-cash expenses
Operating expenses of $17.3 million, primarily related to preparing for U.S. commercial launch of Omidria" and advancing OMS824 and OMS721 clinical programs
U.S. Food and Drug Administration (FDA) approval of Omidria" (phenylephrine and ketorolac injection) 1%/0.3% for use during cataract surgery or intraocular lens replacement (ILR) to maintain pupil size by preventing intraoperative miosis (pupil constriction) and to reduce postoperative ocular pain
FDA clearance of Investigational New Drug (IND) application for Phase 2 clinical trial evaluating OMS721 in thrombotic microangiopathies (TMAs) and initiated Phase 2 trial
"Obtaining U.S. marketing approval for Omidria is a tremendous accomplishment for Omeros," said Gregory A. Demopulos, M.D., chairman and chief executive officer of Omeros. "It marks a pivotal point in our transition to a commercial company, and we are continuing preparations for a planned U.S. product launch in the fourth quarter of 2014. In that same time frame, we also expect to receive a decision on the EU marketing application for Omidria. While we remain focused on the market launch of Omidria, we continue to advance the rest of our pipeline, including our MASP-2 inhibitor OMS721 and PDE10 inhibitor OMS824 Phase 2 clinical programs in patients with TMAs and Huntington's.
OMER's short interest dropped just over 150,000 shares during the second half of June.
6/13/2014 ......... 5,978,036
6/30/2014 ......... 5,823,043
Apparently the 2.5+ million share volume surge on June 23, 24 and 25, when the share price rose from $14.35 to $17.47, was accumulation, not short covering.
scubamoe, I expect to see continued price increases because I generally agree with the logic (if not the price targets) of analysts like WBB and Wedbush that have price targets WAY north of where OMER is today.
Omidria is approved and their pipeline is fascinating. It'll be interesting to see what's happening with the huge short position that was still about 6 million shares mid-June. 2.5 million shares traded in three days early last week while the stock went from $14.50 to $17.50. That could have been substantial short covering but it'd still leave a big short position.
Peter (not Gregory) Demopulos, a BoD member, bought those shares. Still a good sign.
Today (Friday), EADO event, Munich:
08:00 - 10:00 SYMPOSIUM IV
New drugs and trials: An update on immunotherapy and chemotherapy
09:24 - 09:34 PV-10 Vernon Sondak, Tampa, USA [That'd be Moffitt]
Topics in the session, in sequence:
Ipilimumab, Nivolumab, MK3475, Biomarkers for PD-1 response, IL19, MAGE-A3 ASCI, T_VEC, PV-10, Electroporation, Nab-paclitaxel
How do you spell squeeeeeeeeeeeze?
Google that subject to see the whole article.
"Moffitt will receive the largest share of the initial $60 million, about $26 million. It will use the money to hire more researchers, particularly in the field of immunology, harnessing the immune system to help patients fight cancer."
After listening to the OMER replay and reading both the WBB and Wedbush reports, a friend and fellow shareholder who doesn't post on the internet sent me some comments about Omidria which I summarize here:
- "Omidria", here in the U.S, is a 100% Omeros owned product. From production, to marketing, to management of the sales force, it's 100% home grown and OMER-owned.
- OMER will partner with a major pharma for Europe.
- Neither WBB nor Wedbush factors in a cash component from a potential Europe partnership.
- Partnership deals are easier to consummate once a prospective partner clearly understands when the drug can be sold.
- Potential European partners likely believe it's a foregone conclusion that the EU will follow the FDA's lead and approve Omidria.
- Partnership deals typically involve an upfront cash component with milestone payments for approval and then a revenue split from sales.
- My friend has no idea how to model what the cash component of a potential Omidria deal would look like with a European partner, but if OMER is able to consummate such a deal soon, and the cash component is significant, that could be a strong driver for the stock.
- Naturally there are no guarantees on all of the above, but the European partner factor has apparently been overlooked for whatever reasons by WBB and Wedbush.
Wrong rak3269. The PR today is misdated June 3, but it's all new news. It looks like it'll be a very comprehensive CC, even including PH-10 info.
In the article, "Provectus outlines path forward for PV-10", Dr. Weber says:
“This data provides more and more evidence that you are altering both local and systemic immunity in a positive way” said Jeffrey Weber, the senior author of the abstract, from Moffitt Cancer Center.
“It also provides a rationale for combination trials of PV-10 with check point protein inhibitors, such as ipilimumab, pembrolizumab and nivolumab. PV-10 might offer the perfect way to prime the immune system.”
It's very significant that Dr. Weber , the director of Moffitt's Melanoma Research Center of Excellence, is now identified as the senior author on the abstract and a PV-10 proponent. The naysayers like AF now find themselves staring down the best melanoma researchers in the business.
Google that subject ..... excellent article
TLSR: The next catalyst and driver at Omeros would be the launch and revenue build for Omidria, correct? Are we still expecting launch in Q3/14?
JK: Yes, and we could see sales build by Q4/14. We're modeling more significant revenues to begin in Q1/15. As I said, the good news for investors is that Omidria becomes the cash engine that allows Omeros to develop its pipeline.
TLSR: Omidria is a combination of phenylephrine + ketorolac. Aren't ophthalmologists currently using these drugs in their practices during IOL replacement surgeries?
JK: Yes. We published an interview with a key opinion leader who voiced his concern: Why pay $100 for a bundled product if an ophthalmologist could coformulate this for just a few dollars? He was very skeptical. We've seen this type of reaction before. But once the product is built, the compounding pharmacy tends to go away. We believe that once the product is off-the-shelf ready, backed with clinical data, backed with a label and supplied by Omeros, it will be used. We've seen that the U.S. Food and Drug Administration (FDA) tends to shut down compounding pharmacies once there's an approved product in the marketplace.
TLSR: What's the story with the pipeline?
JK: This is where Omeros gets really interesting. I'd highlight OMS721, a human monoclonal antibody that potentially addresses human atypical hemolytic uremic syndrome (aHUS), a form of thrombotic microangiopathy. We think that's a very significant indication. If OMS721 is selectively developed, it is in a position to challenge Alexion Pharmaceuticals Inc.'s (ALXN:NASDAQ) monoclonal antibody product, Soliris (eculizumab), which also targets aHUS. Since it was commercialized in 2007, Soliris has generated more than $400M in global sales, so we think that's an exciting prospect for Omeros. It's gearing up for Phase 2 as we speak, so we're going to be looking at Phase 2 proof-of-concept data in patients. This is the type of indication where you're not going to have to treat a lot of patients to get a good idea about whether the therapy is effective.
On another front, Omeros' phosphodiesterase 10 (PDE10) program has just entered the clinic. We note that program has tremendous potential in a host of disorders, but the most interesting might be Huntington's disease. It's still early days—these are Phase 2 programs—but if we come out of them with significant data, investors are going to have to start taking the Omeros clinical pipeline more seriously.
TLSR: Omeros' PDE10 inhibitor program has multiple indications, including cognitive disorders and schizophrenia. Why are you so positive on this Huntington's program?
JK: Because this seems to be a more selective inhibitor. There may be something dynamic related to how it's binding and its on/off time. So far, in dosing studies, we have not seen some of the traditional side effects associated with other PDE10 inhibitors, like the extrapyramidal tremors. It has the potential to be significant.
Focus on Catalysts to Cash In on Biotech: Jason Kolbert
Source: George S. Mack of The Life Sciences Report (6/4/14)
Intro ..... "When progress is made in drug development, value is created. Investors recognize that progress by purchasing shares in companies when milestones—which act as catalysts—are met. The Maxim Group's Senior Managing Director and Head of Healthcare Jason Kolbert lives by catalysts, and urges his investor clientele to understand there is no other reason to buy a stock except in anticipation of new information that creates value. In this interview with The Life Sciences Report, Kolbert discusses six names that have immense regenerative power for portfolios."
TLSR: Would you mind addressing Omeros Corp. (OMER:NASDAQ)?
JK: I really like following Omeros. It is a specialty pharma coupled with a true biotech company, and is working on a couple of exciting products. Dr. Greg Demopulos, the CEO, is an orthopedic surgeon—he's brilliant.
Omeros has just received approval of Omidria (OMS302; phenylephrine + ketorolac), which was developed for intraocular lens (IOL) replacement. We think Omidria can be reasonably successful. It allows the ophthalmic surgeon to retain both a dilated surgical field, as well as reduce the inflammation and pain associated with the surgery. It provides a convenience factor and a better outcome for what tends to be an elective procedure. There is the potential for Omidria to be a couple-hundred-million-dollar product, and to build free cash flow for the company. That would fund the development of Omeros' pipeline.
By BiotechDaily International staff writers
Posted on 04 Jun 2014
New research examines complete response and induced immune response in melanoma patients that may generate a “bystander effect
Provectus Biopharmaceuticals, Inc. (Knoxville, TN, USA), a development-stage oncology and dermatology biopharmaceutical company, reported that data on its investigational agent PV-10 for intralesional (IL) treatment of locally advanced cutaneous melanoma was featured in two presentations, on June 2, 2014, during the American Society of Clinical Oncology (ASCO) annual meeting held in Chicago (IL USA). These presentations show that IL PV-10 can potentially offer cancer patients control of their cutaneous symptoms and provoke a systemic antitumor immune response that may lead to response of uninjected lesions (the “bystander effect” that has been observed in earlier clinical studies of PV-10).
The first highlighted poster, presented by Sanjiv S. Agarwala, MD, of the St. Luke’s Cancer Center (Bethlehem, PA, USA), was entitled “Efficacy of intralesional rose bengal in patients receiving injection in all existing melanoma in phase II study PV-10-MM-02.” The second highlighted poster, presented by Amod Sarnaik, MD, from Moffitt Cancer Center (Tampa, FL, USA) was titled “Assessment of immune and clinical efficacy after intralesional PV-10 in injected and uninjected metastatic melanoma lesions.”
Dr. Agarwala and coauthors from seven prominent melanoma centers in the United States and Australia studied the safety and efficacy of IL PV-10 in an 80-patient international, multicenter, single arm phase 2 trial. A subgroup analysis of 28 patients with all existing melanoma lesions injected and an additional 26 patients with only one to two uninjected bystander lesions showed that these patients experienced an exceptionally
high rate of response. (Much more in the full article)