Investigational New Drug Application Cleared by FDA for OMS721 in Thrombotic Microangiopathies
-- Phase 2 Clinical Trial Planned to Begin This Quarter --
SEATTLE, April 3, 2014 /PRNewswire/ -- Omeros Corporation (NASDAQ: OMER) today announced that its Investigational New Drug Application (IND) to evaluate OMS721 for the inhibition of complement‑mediated thrombotic microangiopathies (TMAs) has been cleared by the U.S. Food and Drug Administration (FDA). OMS721 is the company's lead human monoclonal antibody targeting mannan-binding lectin-associated serine protease-2 (MASP-2), the key regulator of the lectin pathway of the immune system. Omeros announced last year that the FDA granted OMS721 Orphan Drug designation for the inhibition of complement‑mediated TMAs, a family of rare, debilitating and life-threatening disorders characterized by multiple thrombi (clots) in the microcirculation of the body's organs, most commonly the kidney and brain.
FDA's clearance of the IND allows the initiation of the Phase 2 program for OMS721, which will assess the efficacy and safety of OMS721 in patients with disorders associated with lectin pathway activation. The first OMS721 Phase 2 clinical trial, planned to begin later this quarter, will evaluate the effects of the drug on patients with TMAs, including atypical hemolytic uremic syndrome (aHUS), thrombotic thrombocytopenic purpura (TTP), and stem cell transplant-related TMA. The lectin pathway, one of the principal complement activation pathways in the immune system, is thought to play a central role in the development of TMAs, and OMS721, by targeting and inhibiting MASP-2, blocks the lectin pathway.
[More in the full news release]
Ingalls & Snyder, LLC of New York just filed an SC 13G/A form, having acquired 1,717,860 shares of OMER on 3/18/13. That's 5.1% of OMER's outstanding common stock. I'm assuming this was a slice of the 3/14/14 $11.50 placement. Nice slice ...... $19.7 million, just under 50% of the placement.
And they sound like a solid, high quality organization.
Omeros Invited to Present on OMS824 Phase 2 Clinical Program at the Schizophrenia International Research Conference
-- Conference Focuses on New Drug Development and Cutting Edge Research in Schizophrenia --
SEATTLE, April 1, 2014 /PRNewswire/ -- Omeros Corporation (NASDAQ: OMER) today announced that the company was invited by the organizers of the 2014 Biennial Conference of the Schizophrenia International Research Society (SIRS) to make an oral presentation on OMS824, the company's phosphodiesterase 10 (PDE10) inhibitor in development for the treatment of schizophrenia and Huntington's disease. OMS824 selectively inhibits PDE10, an enzyme expressed in areas of the brain linked to a wide range of diseases that affect cognition. The SIRS Conference will take place in Florence, Italy April 5-9. The Omeros presentation is entitled "Early Clinical Results of the Phosphodiesterase 10 Inhibitor OMS643762 in Development for the Treatment of Schizophrenia and Huntington's Disease" and is scheduled for Sunday April 6 during the pharmaceutical pipeline session. OMS643762 is the reference name for OMS824 in the company's clinical development program.
The presentation at the SIRS Conference will summarize Phase 1 and early Phase 2 data from Omeros' OMS824 clinical program. Steve Whitaker, M.D., Omeros' vice president of clinical development and chief medical officer, will make the presentation. SIRS was founded in 2005 and is dedicated to exchanging information about the latest advances in schizophrenia research among scientists, clinicians, drug developers, and policy makers internationally. The April 5-9 SIRS Conference in Florence is the fourth biennial conference and focuses on development of new drugs and the status of cutting edge research in the field of schizophrenia. The third biennial SIRS Conference held in 2012 was attended by over 1600 researchers from 53 countries.
Provectus Biopharmaceuticals' PV-10 Data to Be Presented at the American Society of Clinical Oncology (ASCO) Annual Meeting
Tuesday April 1, 2014
PV-10 Selected for Poster Highlights Session
McCormick Place in Chicago, IL, May 30-June 3, 2014
KNOXVILLE, Tenn.--(BUSINESS WIRE)--Provectus Biopharmaceuticals, Inc. (OTCQB: PVCT), a development-stage oncology and dermatology biopharmaceutical company, announced today that data on treatment of cutaneous melanoma using its investigational drug PV-10 have been selected to be part of the Poster Highlights Session of the American Society of Clinical Oncology (ASCO) Annual Meeting this year at McCormick Place, Chicago, IL, May 30-June 3, 2014. The time and date of the session are expected to be available on the ASCO website on April 21, 2014.
Sanjiv S. Agarwala, MD, is lead author of abstract #9027, entitled "Efficacy of intralesional Rose Bengal in patients receiving injection of all existing melanoma in phase II study PV-10-MM-02."
Provectus Biopharmaceuticals' PV-10 Data to Be Presented at the HemOnc Today Melanoma and Cutaneous Malignancies Conference
Tuesday April 1, 2014
Sheraton New York Times Square, Friday, April 11, 2014
KNOXVILLE, Tenn.--(BUSINESS WIRE)--Provectus Biopharmaceuticals, Inc. (OTCQB: PVCT), a development-stage oncology and dermatology biopharmaceutical company, announced today that data on PV-10 for cutaneous melanoma will be included in a session at the HemOnc Today - Melanoma and Cutaneous Malignancies Conference. HemOnc Today will be held this year at the Sheraton New York Times Square in New York City on Friday, April 11 and Saturday, April 12.
A new and important point was made by Greg Demopulos this morning ........ a single vial of Omidria added to the irrigation solution may remove the need in lens replacement operations for BOTH pre-op NSAIDS and mydriatic agents. So in addition to the established benefits of Omidria ..... maintenance of dilation and reduction in post-op pain ....... Omidria may provide a significant cost benefit in the surgical suite.
If you'd like to hear Greg's presentation about Omidria's status and their near term plans, it'll take you just three minutes.
Go to Omeros' home page. Under "NEWS", select the 2nd webcast .... the 3/28 one .... and register.
The replay has a 28:48 timeline. Slide to about 13:55 and listen through 17:30.
I strongly recommend doing this if you're interested in OMER and Omidria.
Omeros to Present at BioCentury Future Leaders in the Biotech Industry Conference
SEATTLE, March 21, 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 BioCentury Future Leaders in the Biotech Industry Conference in New York next week. The presentation is scheduled for Friday, March 28, 2014 at 9:00 a.m. EDT.
The presentation will be webcast. The live and archived webcasts can be accessed on the "Events" page of the Company's website.
Option pricing change says something about OMER sentiment
I find it odd that OMER has been weak and has declined about $1 while the April 10 and 11 puts have not really moved. While the apparent volatility of the stock has increased, the implied volatility of the options has declined.
This is keeping me from being tempted to sell more April puts.
I am not saying the April puts has declined in price, because they have not. They are firm to slightly higher when they should be significantly higher because of the $1 share price decline.
I suppose the data are telling me that there is little fear on the part of OMER shareholders so they are not rushing to buy protection and there is no aggressive short buying enough puts to move the price noticeably higher.
Option pricing tells you about sentiment of investors, or at least a subset of investors that includes the most sophisticated, the most bullish and the most fearful. This information is contained in the comparison of the volatility of the share price in comparison to the implied volatility implicit in the price of the option (or the bid and ask).
When I was selling puts a week or two ago, the volatility of the stock was much lower than the implied volatility of the options I was selling. In other words, people were willing to pay a premium over observed stock volatility to get protection. That volatility is about the same for the last month (now 62.95%) but the out of the money (OTM) put options have stayed steady with the stock declining, meaning that there is fewer buyers competing to buy insurance against a decline.
Perhaps the Market is used to OMER bouncing up and down and ignoring for the moment that the swing trade pattern doesn't last forever. Or they expect like you (and to a great extent, like me) that OMER is likely to break out on the upside, perhaps to start the same pattern at a higher level when its NDA get approved.
As of last spring, Dees was the beneficial owner of 5,997,859 shares including 4,543,750 common stock options, second only to Wachter's close to 8,000,000 holdings. Source: April 2013 PRE 14A (proxy).
Furthermore, St. Luke's, Sharp Memorial, M.D. Anderson Cancer Center in Houston, TX, and the University of Louisville in Louisville, KY, as well as key Australian centers, are participating in the expanded access study PV-10-EA-02, which affords access to PV-10 to patients with cutaneous or subcutaneous cancers who have exhausted all other treatment options.
Dees continued, "I want to make clear to our shareholders, the media and the market as a whole that BTD is not guaranteed and if the designation is conferred on PV-10 for melanoma, it does not bypass the need for a new drug application (NDA) and review, as both are required for commercialization of any drug. As I have stated previously, the Agency may yet recommend and it may be in the best interest of Provectus to undertake a small, short bridging study in patients where all tumor burden can be injected. This could occur either before or after we have approval to sell PV-10. Provectus has over $16 million in cash reserves and would not require additional capital or the resources of a partner to conduct such a study. If such a study is conducted, it also fits with needs for an international study supportive of licensure in Australia, Europe, China and India."
Dees concluded, "We are confident that the studies done thus far illustrate the effectiveness and safety of PV-10: if you inject PV-10 into melanoma tumors, the tumors go away. For recurrent, aggressive skin cancers this unique mechanism confers tangible benefit to patients."
In addition to PV-10 for melanoma, Provectus has recently initiated patient enrollment at St. Luke's Hospital in Bethlehem, PA, for protocol PV-10-LC-01, which is assessing safety and preliminary efficacy of PV-10 for treatment of tumors of the liver. This is the third site participating in the study, in addition to Sharp Memorial Hospital, San Diego, CA and The Southeastern Center for Digestive Disorders & Pancreatic Cancer, Tampa, FL.
Provectus Biopharmaceuticals Inc. Submits Application to FDA to Receive Breakthrough Therapy Designation for PV-10 for Treatment of Melanoma
Monday March 24, 2014
FDA Expected to Make Determination Within 60 Days upon Receipt
KNOXVILLE, Tenn.--(BUSINESS WIRE)--Provectus Biopharmaceuticals, Inc. (OTCQB: PVCT), a development-stage oncology and dermatology biopharmaceutical company, announced today that it has applied to the FDA for Breakthrough Therapy Designation (BTD) for PV-10 for the treatment of melanoma. FDA guidelines state that the Agency will make a decision on the application within 60 days of receipt. The Agency's records for FY 2013 show that the Agency's Center for Drug Evaluation and Research (CDER) met that guideline 97% of the time.
Craig Dees, PhD, CEO of Provectus said, "The decision to apply for BTD stems from our Type C meeting held with the FDA's Division of Oncology Products 2 in December 2013. At the meeting FDA expressed willingness to work with Provectus toward initial approval for the novel investigational oncology drug PV-10 in locally advanced cutaneous melanoma. This included a statement in the minutes that data in a cohort of patients that received PV-10 to all existing lesions should be submitted in a formal BTD application."
What we knew from the SEC filing yesterday is now "out" ...
Omeros Closes $40.25 Million Public Offering of Common Stock
SEATTLE, March 19, 2014 /PRNewswire/ -- Omeros Corporation (NASDAQ: OMER) today announced that it has closed the underwritten public offering that was priced and allocated to investors prior to the opening of the market on March 14, 2014, relating to the sale of 3,500,000 shares of its common stock at a price of $11.50 per share for gross proceeds of approximately $40.25 million. The closing included the sale of 456,521 shares of common stock sold pursuant to the overallotment option granted by Omeros to the underwriters, which the underwriters exercised in full. After deducting underwriting discounts and other estimated offering expenses, Omeros will receive net proceeds from the transaction of approximately $37.8 million.
Omeros intends to use the net proceeds of the offering for general corporate purposes, including expenses related to the potential commercialization of Omidria™ (OMS302), as well as for research and development expenses, such as funding further clinical trials for Omeros' OMS824 and OMS721 programs. The net offering proceeds may also be used to advance one or more of Omeros' preclinical programs into clinical trials, to fund preclinical activities, or for capital expenditures, working capital and to otherwise advance Omeros' product candidates toward commercialization.
Cowen and Company, LLC acted as the sole book-running manager for the offering.
Wedbush PacGrow Life Sciences acted as co-lead manager. Needham & Company, LLC, Maxim Group LLC, WBB Securities LLC and MLV & Co. LLC acted as co-managers.
[More in the news release]
It's worth noting that OMER is now trading at about 16% OVER its offering price and ~9% over its pre-offering close even with ~10% dilution.
Item 1.01 Entry into a Material Definitive Agreement.
On March 14, 2014, Omeros Corporation (the “Company”) entered into an underwriting agreement (the “Underwriting Agreement”) with Cowen and Company, LLC, as representative of the several underwriters named therein (collectively, the “Underwriters”) relating to the public offer and sale of 3,043,479 shares of the Company’s common stock, $0.01 par value per share (the “Common Stock”), at a price to the public of $11.50 per share (the “Offering Price”). Under the terms of the Underwriting Agreement, the Company also granted the Underwriters a 30-day option to purchase up to an additional 456,521 shares of the Common Stock to cover overallotments, which the Underwriters have exercised in full. The net proceeds to the Company from the sale of the Common Stock, after deducting the underwriting discount and commission and other estimated offering expenses payable by the Company, are expected to be approximately $37.8 million. The offering is expected to close on March 19, 2014, subject to the satisfaction of customary closing conditions.
Using many of the same investment bankers/managers as OMER, another biotech ... DYAX .... also offered common shares to the public on Friday. Both OMER and DYAX priced their offerings below their Thursday closing prices. OMER's offering was priced 6.5% below Thursday's close, DYAX's was priced 9% below.
Including overallotments, DYAX's offering represents 7.3% dilution while OMER's will be 11.5%.
On Friday, DYAX closed down 9.2% from Thursday's close, or 1.9% more than its dilution, while OMER closed down 7.7%, or 3.8% less than its dilution.
This suggests that OMER's offering was greeted more favorably than DYAX's.
In any event, OMER will come out of this with $32.8 million to $38 million in added cash, significantly strengthening its financial position to move forward on multiple fronts including the expected commercial launch of Omidria later this year.
Omeros Prices $35.0 Million Public Offering of Common Stock
SEATTLE, March 14, 2014 /PRNewswire/ -- Omeros Corporation (NASDAQ: OMER) today announced that it has priced an underwritten public offering of 3,043,479 shares of its common stock at a price to the public of $11.50 per share for gross proceeds of $35.0 million. The net proceeds from the sale of the shares, after deducting the underwriters' discounts and other estimated offering expenses, will be approximately $32.8 million. Omeros has also granted the underwriters a 30-day option to purchase up to an additional 456,521 shares of common stock to cover overallotments, if any, which would result in additional gross proceeds of approximately $5.2 million if exercised in full.
Omeros intends to use the net proceeds of the offering for general corporate purposes, including expenses related to the potential commercialization of Omidria™ (OMS302), as well as for research and development expenses, such as funding further clinical trials for Omeros' OMS824 and OMS721 programs. The net offering proceeds may also be used to advance one or more of Omeros' preclinical programs into clinical trials, to fund preclinical activities, or for capital expenditures, working capital and to otherwise advance Omeros' product candidates toward commercialization. The offering is expected to close on or about March 19, 2014, subject to the satisfaction of customary closing conditions.
[more in the PR]
From the PR .....
" Prof. Remuzzi's laboratories have previously shown in this same model system that treatment with agents that block the complement factor C5 has a similar inhibitory effect on complement deposition. Eculizumab (Soliris®) is an anti-C5 monoclonal antibody that is approved by the FDA and the European Medicines Agency to treat patients with aHUS.
"The OMS721 data in serum samples from aHUS patients are of great interest even in relation to disease pathophysiology," stated Prof. Remuzzi, MD ."
It would be interesting to know how OMS721 compares with Soliris quantitatively. Prof. Remuzzi's comment suggests that OMS721 might have a superior inhibitory effect.
Soliris is an approved drug from Alexion (ALXN) that sports a $35 Billion market cap ........ roughly 90 times OMER's.