Click here to close now.

Welcome!

.NET Authors: Dana Gardner, Pat Romanski, Andreas Grabner, Elizabeth White, Tad Anderson

News Feed Item

Omeros Corporation Reports Third Quarter 2012 Financial Results

SEATTLE, Nov. 9, 2012 /PRNewswire/ -- Omeros Corporation (NASDAQ: OMER), a clinical-stage biopharmaceutical company committed to discovering, developing and commercializing products targeting inflammation, coagulopathies and disorders of the central nervous system, today announced its financial results for the third quarter of 2012.

Financial Results

Total operating expenses for the quarter ended September 30, 2012 were $14.5 million compared to $7.2 million for the same period in 2011. The increase in operating expenses primarily relates to a one-time litigation settlement payment of $3.95 million, which our insurance company has agreed to reimburse to us subject to a reservation of rights, increased Phase 3 clinical trial expenses for OMS302 and increased employee expenses, partially offset by a decrease in expenses in connection with preclinical work for other programs. Given that the $3.95 million that Omeros' insurer has agreed to reimburse had not been received by Omeros as of September 30, 2012, that amount is not included in operating expenses for the 2012 period.  For the quarter ended September 30, 2012, Omeros reported a net loss of $13.3 million, or $0.51 per share, compared to a net loss of $6.5 million, or $0.29 per share, for the same period in 2011. At September 30, 2012, Omeros had cash, cash equivalents and short-term investments of $30.6 million.  

"Now with positive results from both of our two pivotal Phase 3 clinical trials evaluating OMS302, Omeros is becoming a commercial company," said Gregory A. Demopulos, M.D., chairman and chief executive officer of Omeros. "We are working to file an NDA in the first quarter of 2013 followed by an MAA in mid-year, and we look forward to releasing data from two more clinical programs before year-end – our Phase 3 meniscectomy and our Phase 1 PDE10 programs. Our clinical pipeline is expanding, and as many as three additional programs could enter the clinic in 2013.  We continue to execute on our strategy of creating multiple opportunities for success."

Third Quarter and Recent Highlights

  • Completed a public offering pursuant to which it sold 3,365,854 shares of common stock at a price of $10.25 per share.  Omeros' net proceeds from the transaction were $32.3 million.
  • Reported the completion of enrollment in the first of two planned pivotal Phase 3 clinical trials evaluating OMS103HP in patients undergoing arthroscopic partial meniscectomy surgery. OMS103HP is a proprietary drug product added to standard irrigation solutions and delivered to the operative site throughout arthroscopy to preemptively block the molecular-signaling and biochemical cascade caused by surgical trauma and to improve postoperative functional outcomes. Omeros expects to announce data from this Phase 3 trial before year-end.
  • Announced the identification of compounds that interact selectively with nine additional orphan G protein-coupled receptors (GPCRs), bringing the total number of orphans GPCRs unlocked by Omeros to 46, representing over half of the Class A orphan GPCRs and equaling the number of GPCRs targeted by over 30 percent of all currently marketed drugs. These nine orphans are linked to a series of important indications, including several types of cancer, autism, pain, osteoarthritis, neuropsychiatric disorders, and appetite and body weight.
  • Began enrolling patients in a Phase 1 dose-ranging clinical trial of OMS824, Omeros' lead compound from its phosphodiesterase 10 (PDE10) program for schizophrenia and other cognitive disorders.  This study will evaluate the drug's safety, tolerability and pharmacokinetics in healthy subjects, and Omeros expects data before year-end.
  • Announced that Omeros, its chief executive officer and its former chief financial officer entered into an agreement settling their respective claims. A description of this settlement agreement and the related lawsuit are included in Omeros' Current Report on Form 8-K filed with the U.S. Securities and Exchange Commission on November 1, 2012.  
  • Reported positive data from the second of its two pivotal Phase 3 clinical trials evaluating OMS302 in patients undergoing intraocular lens replacement surgery.  In this second Phase 3 clinical trial comparing OMS302 to placebo, OMS302 met its co-primary endpoints by demonstrating statistically significant (p<0.00001) maintenance of intraoperative mydriasis (pupil dilation) and statistically significant (p=0.0002) reduction of pain in the early postoperative period. Now with positive data from both trials in the OMS302 Phase 3 clinical program, Omeros is targeting submission of a New Drug Application to the U.S. Food and Drug Administration in the first quarter of 2013 and of a Marketing Authorization Application to the European Medicines Agency in mid-2013, with a planned market launch in 2014.

About Omeros Corporation

Omeros is a clinical-stage biopharmaceutical company committed to discovering, developing and commercializing products targeting inflammation, coagulopathies and disorders of the central nervous system. The Company's most clinically advanced product candidates are derived from its proprietary PharmacoSurgery™ platform designed to improve clinical outcomes of patients undergoing a wide range of surgical and medical procedures. Omeros has four ongoing clinical development programs. Omeros may also have the near-term capability, through its GPCR program, to add a large number of new drug targets and their corresponding compounds to the market. Behind its clinical candidates and GPCR platform, Omeros is building a diverse pipeline of protein and small-molecule preclinical programs targeting inflammation, coagulopathies and central nervous system disorders.

Forward-Looking Statements

This press release contains forward-looking statements as defined within the Private Securities Litigation Reform Act of 1995, which are subject to the "safe harbor" created by those sections. These statements include, but are not limited to, Omeros' expectations regarding when it will submit an NDA and MAA for OMS302; when sales may commence for OMS302; when it will announce the results from its Phase 3 OMS103HP and Phase 1 PDE10 clinical trials; the number of its programs that will enter the clinic in 2013; and that Omeros may have capability, through its GPCR program, to add a large number of new drug targets and their corresponding compounds to the market. Forward-looking statements are based on management's beliefs and assumptions and on information available to management only as of the date of this press release. Omeros' actual results could differ materially from those anticipated in these forward-looking statements for many reasons, including, without limitation, the risks, uncertainties and other factors described under the heading "Risk Factors" in the Company's Quarterly Report on Form 10-Q filed with the Securities and Exchange Commission on November 9, 2012. Given these risks, uncertainties and other factors, you should not place undue reliance on these forward-looking statements, and the Company assumes no obligation to update these forward-looking statements publicly, even if new information becomes available in the future.

OMEROS CORPORATION

CONSOLIDATED STATEMENTS OF OPERATIONS

(In thousands, except share and per share data)




















Three Months Ended

Nine Months Ended



September 30,

September 30,



2012

2011

2012

2011



(unaudited)

(unaudited)

Revenue

$           1,417

$              987

$               4,439

$               3,381

Operating expenses:






Research and development

7,764

5,321

22,568

14,823

General and administrative

2,736

1,830

7,270

6,121

Loss on settlement

3,953

-

3,953

-

Total operating expenses

14,453

7,151

33,791

20,944

Loss from operations

(13,036)

(6,164)

(29,352)

(17,563)

Investment income

14

9

32

40

Interest expense

(413)

(528)

(1,360)

(1,348)

Other income, (expense) net

159

171

(30)

526

Net loss

$      (13,276)

$        (6,512)

$           (30,710)

$          (18,345)

Basic and diluted net loss per common share

$           (0.51)

$          (0.29)

$               (1.30)

$               (0.83)

Weighted-average shares used to compute basic and diluted net loss per common share

25,834,730

22,246,430

23,578,724

22,156,883

 

OMEROS CORPORATION

CONSOLIDATED BALANCE SHEET DATA

(In thousands)





September 30,

December 31,





2012

2011












Cash and cash equivalents and short-term investments

$             30,629

$             24,570

Total assets

32,761

26,982

Total notes payable

15,052

19,446

Total current liabilities

21,811

18,985

Accumulated deficit

(206,843)

(176,133)

Total shareholders' equity (deficit)

(820)

(5,554)

 

SOURCE Omeros Corporation

More Stories By PR Newswire

Copyright © 2007 PR Newswire. All rights reserved. Republication or redistribution of PRNewswire content is expressly prohibited without the prior written consent of PRNewswire. PRNewswire shall not be liable for any errors or delays in the content, or for any actions taken in reliance thereon.

@ThingsExpo Stories
Analytics is the foundation of smart data and now, with the ability to run Hadoop directly on smart storage systems like Cloudian HyperStore, enterprises will gain huge business advantages in terms of scalability, efficiency and cost savings as they move closer to realizing the potential of the Internet of Things. In his session at 16th Cloud Expo, Paul Turner, technology evangelist and CMO at Cloudian, Inc., will discuss the revolutionary notion that the storage world is transitioning from mere Big Data to smart data. He will argue that today’s hybrid cloud storage solutions, with commodity...
Cloud data governance was previously an avoided function when cloud deployments were relatively small. With the rapid adoption in public cloud – both rogue and sanctioned, it’s not uncommon to find regulated data dumped into public cloud and unprotected. This is why enterprises and cloud providers alike need to embrace a cloud data governance function and map policies, processes and technology controls accordingly. In her session at 15th Cloud Expo, Evelyn de Souza, Data Privacy and Compliance Strategy Leader at Cisco Systems, will focus on how to set up a cloud data governance program and s...
Roberto Medrano, Executive Vice President at SOA Software, had reached 30,000 page views on his home page - http://RobertoMedrano.SYS-CON.com/ - on the SYS-CON family of online magazines, which includes Cloud Computing Journal, Internet of Things Journal, Big Data Journal, and SOA World Magazine. He is a recognized executive in the information technology fields of SOA, internet security, governance, and compliance. He has extensive experience with both start-ups and large companies, having been involved at the beginning of four IT industries: EDA, Open Systems, Computer Security and now SOA.
The industrial software market has treated data with the mentality of “collect everything now, worry about how to use it later.” We now find ourselves buried in data, with the pervasive connectivity of the (Industrial) Internet of Things only piling on more numbers. There’s too much data and not enough information. In his session at @ThingsExpo, Bob Gates, Global Marketing Director, GE’s Intelligent Platforms business, to discuss how realizing the power of IoT, software developers are now focused on understanding how industrial data can create intelligence for industrial operations. Imagine ...
We certainly live in interesting technological times. And no more interesting than the current competing IoT standards for connectivity. Various standards bodies, approaches, and ecosystems are vying for mindshare and positioning for a competitive edge. It is clear that when the dust settles, we will have new protocols, evolved protocols, that will change the way we interact with devices and infrastructure. We will also have evolved web protocols, like HTTP/2, that will be changing the very core of our infrastructures. At the same time, we have old approaches made new again like micro-services...
Every innovation or invention was originally a daydream. You like to imagine a “what-if” scenario. And with all the attention being paid to the so-called Internet of Things (IoT) you don’t have to stretch the imagination too much to see how this may impact commercial and homeowners insurance. We’re beyond the point of accepting this as a leap of faith. The groundwork is laid. Now it’s just a matter of time. We can thank the inventors of smart thermostats for developing a practical business application that everyone can relate to. Gone are the salad days of smart home apps, the early chalkb...
Operational Hadoop and the Lambda Architecture for Streaming Data Apache Hadoop is emerging as a distributed platform for handling large and fast incoming streams of data. Predictive maintenance, supply chain optimization, and Internet-of-Things analysis are examples where Hadoop provides the scalable storage, processing, and analytics platform to gain meaningful insights from granular data that is typically only valuable from a large-scale, aggregate view. One architecture useful for capturing and analyzing streaming data is the Lambda Architecture, representing a model of how to analyze rea...
SYS-CON Events announced today that Vitria Technology, Inc. will exhibit at SYS-CON’s @ThingsExpo, which will take place on June 9-11, 2015, at the Javits Center in New York City, NY. Vitria will showcase the company’s new IoT Analytics Platform through live demonstrations at booth #330. Vitria’s IoT Analytics Platform, fully integrated and powered by an operational intelligence engine, enables customers to rapidly build and operationalize advanced analytics to deliver timely business outcomes for use cases across the industrial, enterprise, and consumer segments.
Today’s enterprise is being driven by disruptive competitive and human capital requirements to provide enterprise application access through not only desktops, but also mobile devices. To retrofit existing programs across all these devices using traditional programming methods is very costly and time consuming – often prohibitively so. In his session at @ThingsExpo, Jesse Shiah, CEO, President, and Co-Founder of AgilePoint Inc., discussed how you can create applications that run on all mobile devices as well as laptops and desktops using a visual drag-and-drop application – and eForms-buildi...
Containers and microservices have become topics of intense interest throughout the cloud developer and enterprise IT communities. Accordingly, attendees at the upcoming 16th Cloud Expo at the Javits Center in New York June 9-11 will find fresh new content in a new track called PaaS | Containers & Microservices Containers are not being considered for the first time by the cloud community, but a current era of re-consideration has pushed them to the top of the cloud agenda. With the launch of Docker's initial release in March of 2013, interest was revved up several notches. Then late last...
SYS-CON Events announced today that Dyn, the worldwide leader in Internet Performance, will exhibit at SYS-CON's 16th International Cloud Expo®, which will take place on June 9-11, 2015, at the Javits Center in New York City, NY. Dyn is a cloud-based Internet Performance company. Dyn helps companies monitor, control, and optimize online infrastructure for an exceptional end-user experience. Through a world-class network and unrivaled, objective intelligence into Internet conditions, Dyn ensures traffic gets delivered faster, safer, and more reliably than ever.
In their session at @ThingsExpo, Shyam Varan Nath, Principal Architect at GE, and Ibrahim Gokcen, who leads GE's advanced IoT analytics, focused on the Internet of Things / Industrial Internet and how to make it operational for business end-users. Learn about the challenges posed by machine and sensor data and how to marry it with enterprise data. They also discussed the tips and tricks to provide the Industrial Internet as an end-user consumable service using Big Data Analytics and Industrial Cloud.
Performance is the intersection of power, agility, control, and choice. If you value performance, and more specifically consistent performance, you need to look beyond simple virtualized compute. Many factors need to be considered to create a truly performant environment. In his General Session at 15th Cloud Expo, Harold Hannon, Sr. Software Architect at SoftLayer, discussed how to take advantage of a multitude of compute options and platform features to make cloud the cornerstone of your online presence.
The explosion of connected devices / sensors is creating an ever-expanding set of new and valuable data. In parallel the emerging capability of Big Data technologies to store, access, analyze, and react to this data is producing changes in business models under the umbrella of the Internet of Things (IoT). In particular within the Insurance industry, IoT appears positioned to enable deep changes by altering relationships between insurers, distributors, and the insured. In his session at @ThingsExpo, Michael Sick, a Senior Manager and Big Data Architect within Ernst and Young's Financial Servi...
Even as cloud and managed services grow increasingly central to business strategy and performance, challenges remain. The biggest sticking point for companies seeking to capitalize on the cloud is data security. Keeping data safe is an issue in any computing environment, and it has been a focus since the earliest days of the cloud revolution. Understandably so: a lot can go wrong when you allow valuable information to live outside the firewall. Recent revelations about government snooping, along with a steady stream of well-publicized data breaches, only add to the uncertainty
The explosion of connected devices / sensors is creating an ever-expanding set of new and valuable data. In parallel the emerging capability of Big Data technologies to store, access, analyze, and react to this data is producing changes in business models under the umbrella of the Internet of Things (IoT). In particular within the Insurance industry, IoT appears positioned to enable deep changes by altering relationships between insurers, distributors, and the insured. In his session at @ThingsExpo, Michael Sick, a Senior Manager and Big Data Architect within Ernst and Young's Financial Servi...
PubNub on Monday has announced that it is partnering with IBM to bring its sophisticated real-time data streaming and messaging capabilities to Bluemix, IBM’s cloud development platform. “Today’s app and connected devices require an always-on connection, but building a secure, scalable solution from the ground up is time consuming, resource intensive, and error-prone,” said Todd Greene, CEO of PubNub. “PubNub enables web, mobile and IoT developers building apps on IBM Bluemix to quickly add scalable realtime functionality with minimal effort and cost.”
Docker is an excellent platform for organizations interested in running microservices. It offers portability and consistency between development and production environments, quick provisioning times, and a simple way to isolate services. In his session at DevOps Summit at 16th Cloud Expo, Shannon Williams, co-founder of Rancher Labs, will walk through these and other benefits of using Docker to run microservices, and provide an overview of RancherOS, a minimalist distribution of Linux designed expressly to run Docker. He will also discuss Rancher, an orchestration and service discovery platf...
Sensor-enabled things are becoming more commonplace, precursors to a larger and more complex framework that most consider the ultimate promise of the IoT: things connecting, interacting, sharing, storing, and over time perhaps learning and predicting based on habits, behaviors, location, preferences, purchases and more. In his session at @ThingsExpo, Tom Wesselman, Director of Communications Ecosystem Architecture at Plantronics, will examine the still nascent IoT as it is coalescing, including what it is today, what it might ultimately be, the role of wearable tech, and technology gaps stil...
With several hundred implementations of IoT-enabled solutions in the past 12 months alone, this session will focus on experience over the art of the possible. Many can only imagine the most advanced telematics platform ever deployed, supporting millions of customers, producing tens of thousands events or GBs per trip, and hundreds of TBs per month. With the ability to support a billion sensor events per second, over 30PB of warm data for analytics, and hundreds of PBs for an data analytics archive, in his session at @ThingsExpo, Jim Kaskade, Vice President and General Manager, Big Data & Ana...