– Conference Call Today at 4:30 p.m. ET –
SEATTLE--(BUSINESS WIRE)-- Omeros Corporation (Nasdaq: OMER), a clinical-stage biopharmaceutical company committed to discovering, developing and commercializing small-molecule and protein therapeutics for large-market as well as orphan indications targeting inflammation and immunologic diseases, including complement-mediated diseases and cancers, today announced recent highlights and developments as well as financial results for the third quarter ended September 30, 2022, which include:
- For the quarter ended September 30, 2022, we earned royalties of $16.5 million on net sales of our former ophthalmology product OMIDRIA®. Royalties earned in the quarter represent 50 percent of net sales of OMIDRIA by Rayner Surgical, Inc. (Rayner), which purchased our ophthalmology assets in December 2021. Rayner’s U.S. net sales of OMIDRIA were $33.0 million for the third quarter of 2022.
- Net loss in 3Q 2022 was $17.5 million, or $0.28 per share, which included $4.6 million of non-cash expenses, or $0.07 per share. This compares to a net loss of $22.7 million, or $0.36 per share for the prior year quarter, which included $6.4 million of non-cash expenses, or $0.10 per share.
- On September 30, 2022, we sold to DRI Healthcare Acquisitions LP (DRI) an interest in a portion of our future OMIDRIA royalty receivables for a cash purchase price of $125.0 million. The purchased royalty interest entitles DRI to receive royalty payments on OMIDRIA net sales between September 1, 2022 and December 31, 2030, up to the amount of maximum caps established for each annual period. The maximum aggregate payout DRI is entitled to receive is $188.4 million.
- At September 30, 2022, we had $221.0 million of cash, cash equivalents and short-term investments.
- As announced yesterday, we received the decision by FDA’s Office of New Drugs (OND) denying our appeal of the complete response letter (CRL) issued earlier by FDA concerning the biologics license application (BLA) for narsoplimab in hematopoietic stem cell transplant-associated microangiopathy (TA-TMA). Although our request for immediate resubmission and labeling discussions was denied, the decision proposes a path forward for resubmission of the BLA based on survival data from the completed pivotal trial versus a historical control group, with or without an independent literature analysis.
- In November 2022, the Centers for Medicare and Medicaid Services (CMS) issued its final Hospital Outpatient Prospective Payment and Ambulatory Surgical Center Payment Systems rule for calendar year 2023. The rule confirms that for calendar year 2023 CMS will continue to pay separately for OMIDRIA when used in ambulatory surgical centers.
“FDA’s decision on our CRL appeal request provides paths forward that are based on a comparison of patient survival in our pivotal trial to historical survival data in TA-TMA and to response data in the literature. Together with our regulatory and legal advisors, we are assessing potential next steps and look forward to working with the Agency to approve narsoplimab as quickly as possible,” said Gregory A. Demopulos, M.D., Omeros’ chairman and chief executive officer. “Also heading into 2023, we have established financial flexibility with our royalty monetization transaction, which could be further strengthened by our receipt of the $200-million OMIDRIA-related milestone payment. From our clinical trials, throughout the coming year we anticipate data from our MASP-3 inhibitor OMS906 in PNH and C3 glomerulopathy beginning in the first quarter, from our Phase 1 program for our long-acting MASP-2 inhibitor in the second quarter and, in mid-year, from our narsoplimab Phase 3 trial in IgA nephropathy. We also expect news from our OMS527 PDE7 inhibitor and immuno-oncology programs. All of these assets are rapidly advancing – collectively representing significant opportunities and substantial enterprise value.”
Third Quarter and Recent Clinical Developments
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Recent developments regarding narsoplimab, our lead monoclonal antibody targeting mannan-binding lectin-associated serine protease-2 (MASP-2) in advanced clinical programs for the treatment of TA-TMA, immunoglobulin A (IgA) nephropathy, atypical hemolytic uremic syndrome (aHUS) and severely ill COVID-19 patients, include the following:
- On October 18, 2021, we announced the receipt of a CRL from FDA indicating that the BLA for narsoplimab in TA-TMA could not be approved as submitted. Following additional interactions with FDA regarding the BLA we submitted a Formal Dispute Resolution Request, in June 2022, appealing the issuance of the CRL to a higher level within FDA, in this case OND, and requesting that OND direct the review division to accept a Class 1 resubmission of the BLA and to commence labeling discussions immediately thereafter. In November 2022, we received OND’s decision denying our appeal. Although our request for immediate resubmission and labeling discussions was denied, the decision proposes a path forward for the resubmission of the BLA based on survival data from the completed pivotal trial versus a historical control group. Specifically, the decision proposes the resubmission of the narsoplimab BLA including a comparison of the existing response data from the completed pivotal trial to a threshold derived from an independent literature analysis and evidence of increased survival from patients in the pivotal trial compared to an appropriate historical control group. It also notes that persuasive evidence of superior survival versus a well-matched historical control group could be sufficient even in the absence of the independent literature analysis. The specific approach to any resubmission and its details would be determined through discussion with the review division.
- Enrollment in our Phase 3 ARTEMIS-IGAN trial continues to progress toward an anticipated readout of 9-month data on proteinuria by mid-next year.
- A case report describing the successful treatment of an adult patient with recurrent IgA nephropathy under compassionate use was presented at the American Society of Nephrology’s kidney week congress held last week in Orlando, Florida. The poster presentation is entitled Narsoplimab Treatment for Recurrent IgA Nephropathy Stabilized eGFR and Proteinuria.
- A poster presentation describing the design of our open-label Phase 2 study evaluating efficacy and safety of narsoplimab in pediatric patients with high-risk TA-TMA will be presented at the annual meeting of the American Society of Hematology to be held in December 2022 in New Orleans, Louisiana.
- In September 2022, results of the narsoplimab treatment arm of the I-SPY COVID-19 adaptive platform trial sponsored by Quantum Leap Healthcare Collaborative were announced. Although the narsoplimab treatment arm was terminated prior to accrual of the maximum of 125 patients, analysis in the randomized patient population showed that the addition of narsoplimab to treatment of critically ill patients with COVID-19 reduces the mortality risk (hazard ratio [HR]=0.81, with probability [HR