Release Date: May 15, 2024
For the complete transcript of the earnings call, please refer to the full earnings call transcript.
Positive Points
- Omeros Corp (OMER, Financial) has a strong cash position with $230.3 million available to support ongoing operations and debt service, expected to fund operations into 2026.
- The company is optimistic about the approval of narsoplimab, with strong support from the transplant community and ongoing supply under the expanded access program.
- OMS906, targeting the alternative pathway of complement, is advancing well with multiple ongoing Phase 2 studies showing promising results.
- OMS1029 has successfully completed a Phase 1 study, supporting once quarterly dosing, and is moving towards Phase 2 trials in potential large-value indications like wet AMD.
- Omeros Corp (OMER) is developing OMS527, a PDE7 inhibitor, as a potential treatment for cocaine use disorder with funding from the National Institute on Drug Abuse.
Negative Points
- Omeros Corp (OMER) reported a significant net loss of $37.2 million for the first quarter of 2024, compared to a net loss of $9.1 million in the previous quarter.
- The financial burden of the expanded access program for narsoplimab is being assessed, indicating potential challenges in maintaining the program.
- There is no firm date for the BLA resubmission or the related decision date for approval of narsoplimab, creating uncertainty about the timeline for potential market entry.
- The company faces ongoing challenges with regulatory interactions, as indicated by the lack of detailed updates on progress with the FDA regarding narsoplimab.
- Despite the potential of OMS906, the drug is still in the Phase 2 trial stage, and its success in Phase 3 trials and subsequent market acceptance remains uncertain.
Q & A Highlights
Q: Hi, Greg. Thank you for taking the call. Just one question on 906. You were pretty extensive in on how you described the therapeutic window and how it worked, but tell me something, what are the KOLs giving you in terms of information on what they see and how important this will be? And then I've got one follow-up after that. Thank you.
A: Gregory Demopulos - Omeros Corp - Chairman of the Board, President, Chief Executive Officer: Okay. Well, let me first take that and then I think I'll hand it off to clinical and commercial as well. But I think as we said in the prepared comments that the response with the market research done to-date, which has included physicians and within that physician group, key opinion leaders, has been consistently positive.
Q: Hey, good afternoon, guys. Thanks for the question for the OMS906 update coming, wanted to clarify that the data we'll see at EHA is just through week 24 and that final switch-over portion of the trial is later in the year. Is that right?
A: Gregory Demopulos - Omeros Corp - Chairman of the Board, President, Chief Executive Officer: Sure. First, in answer to your initial question, yes, it's through the first 24 weeks. So it's through the combination therapy portion of the clinical trial. We are still collecting monotherapy data, and we expect to have those data later in the year.
Q: Hi, everyone. Thanks for taking my questions. I'm on for Serge today. First, regarding the OMS906 trials, can you provide any color on what we can expect after the data is released and particularly whether we can expect meetings with the FDA ahead of the Phase 3 initiation?
A: Gregory Demopulos - Omeros Corp - Chairman of the Board, President, Chief Executive Officer: Yes, in answer to your first question, discussions, interactions are ongoing with both US and European regulators as we prepare for the Phase 3 trial or a Phase 3 program. So let me just turn to Cathy and she -- Cathy, can you add more color to that?
Q: And then second, regarding the narsoplimab BLA resubmission, obviously you mentioned updates are soon to come. Can you give any context to progress made with the FDA since we last received an update in April, whether kind of if the ball is in their hands at this time? Thanks.
A: Gregory Demopulos - Omeros Corp - Chairman of the Board, President, Chief Executive Officer: Okay. Thank you. In answer to your second question, we really are not and have not, do not provide sort of running commentary on our interactions with regulators. So there's not much that I have to say there other than we clearly are comfortable, confident in the data that we have. We believe the drug certainly warrants approval, and that is our objective.
Q: You actually did -- ask and answered -- but I appreciate the detail and the depth that you went into. Let me hop back into queue. Thanks very much.
A: Gregory Demopulos - Omeros Corp - Chairman of the Board, President, Chief Executive Officer: Steve, I think you said you had a follow-up, but I don't know we may have answered that already for you, but let us know.
Q: What I'll add is that we are in the middle of extensive market research, and it's so exciting to hear the reactions to the product profile for 906. Bottom line, the doctors are telling us patients need options, and they're very encouraged by what they're seeing, both efficacy, but delivered with a low treatment burden, essentially moving to only four times a year. So we're also excited about the opportunity to meet with patients in a market research capacity later this month and continue this work.
A: Nadia Dac - Omeros Corp - Chief Commercial Officer: What I'll add is that we are in the middle of extensive market research, and it's so exciting to hear the reactions to the product profile for 906. Bottom line, the doctors are telling us patients need options, and they're very encouraged by what they're seeing, both efficacy, but delivered with a low treatment burden, essentially moving to only four times a year. So we're also excited about the opportunity to meet with patients in a market research capacity later this month and continue this work.
For the complete transcript of the earnings call, please refer to the full earnings call transcript.
