Q2 2025 Omeros Corp Earnings Call

Part of it at the company's request and a replay will be available on the company's website. One week from today I will now turn the call over to Jennifer Williams Investor Relations for minerals. Good afternoon, and thank you for joining us.

Before we begin I'd like to remind you that certain statements made during this call our program.

These statements reflect management's current beliefs and expectations as of today and are subject to change forward looking statements involve risks and uncertainties that could cause actual results to differ materially for a discussion of these risks and uncertainties. Please refer to the special note and the risk factors section regarding forward looking statements and our quarterly report on Form 10-Q filed today with.

The SEC and the risk factors section of our most recent annual report on Form 10-K with that I'll turn the call over to chairman and CEO of <unk>, Dr. Greg Demopoulos.

Thank you Jennifer and good afternoon, everyone.

Joining me today are David <unk>, our Chief Accounting Officer, <unk>, Chief commercial officer.

Dr. Andreas Grauer, Chief Medical Officer, Dr. Cathy Melfi, Chief regulatory officer, and Dr. Steve would occur Vice president of clinical.

I'll begin with an overview of our second quarter 2025 financial results and provide updates across our development programs.

Evan will then walk us through the financials in more detail and we will open the call for questions.

Our net loss for the second quarter of 2025 was $25 4 million or <unk> 43 per share <unk>.

Compared to a net loss of $33 5 million or <unk> 58 per share in the first quarter of this year.

As of June 32025, we had $28 $7 million in cash and investments.

This was further strengthened by a registered direct offering completed on July 28, 2025, which raised $20 6 million in net proceeds.

During the quarter, we took decisive steps to strengthen our balance sheet and extend our debt maturity profile.

Through a combination of convertible note exchanges and equity conversions, we reduced the outstanding principal on our 2026 notes from $98 million to $17 million.

Eliminated a $20 million mandatory prepayment on our term loan.

<unk> extended.

The large majority of our debt up to 2029.

These actions, including the July offering with polar asset management partners reduced our near term payment obligations by over $100 million.

This further positions us to focus capital on advancing key programs and supporting the anticipated launch of nurse thoughtful about.

We have removed a major structural overhang streamlined our balance sheet and are now better positioned to access additional capital through partnerships.

Equity or debt offerings are sales under our active ATM facility.

As previously disclosed we are in discussions regarding potential asset acquisition <unk> licensing agreements involving certain of our clinical assets.

The most advanced of these discussions is driving toward a multibillion dollar transaction.

<unk> of royalties.

Upon closing, we expect to receive an upfront cash payment sufficient to repay in full the $67 $1 million term loan outstanding.

Under our senior secured credit facility.

Repay at maturity the remaining $17 $1 million principal balance of our 2026 convertible notes.

And provide sufficient capital for over 12 months post closing operations.

This transaction is also expected to include near and longer term milestones and if regulatory approval is obtained.

Sales based milestones and royalties.

Let's now turn to the anticipated approval and launch of in our supplement of our proprietary human monoclonal antibody against mask to the key activator of the lectin pathway of complement.

While we have identified several commercially attractive follow on indications for <unk>. The initial indication is stem cell transplant associated thrombotic microangiopathy or Ta TMA, a life threatening complication of stem cell transplant.

In March we resubmitted, our biologics license application or BLA for our software to map in Ta TMA.

David Borges: Good afternoon and welcome to today's earnings call for Omeros Corporation. At this time, all participants are in a listen-only mode. After the company's remarks, we will conduct a question and answer session. Please be advised this call is being recorded at the company's request, and the replay will be available on the company's website one week from today. I will now turn the call over to Jennifer Williams, investor relations for Omeros.

Speaker #2: Good afternoon and welcome to today's earnings call for Omeros Q2. At this time, all participants are in a listen-only mode. After the company's remarks, we will conduct a question-and-answer session.

The FDA accepted the <unk> the <unk>.

Submission for review.

And assigned a <unk> target action date of September 25th.

Speaker #2: Please be advised, this call is being recorded at the company's request and the replay will be available on the company's website one week from today.

Following our submission of additional information requested by FDA.

Speaker #2: I will now turn the call over to Jennifer Williams, Investor Relations for Omeros.

The agency extended Paducah date to December 2006.

Jennifer Williams: Good afternoon and thank you for joining us. Before we begin, I'd like to remind you that certain statements made during this call are forward-looking. These statements reflect management's current beliefs and expectations as of today and are subject to change. Forward-looking statements involve risks and uncertainties that could cause actual results to differ materially. For a discussion of these risks and uncertainties, please refer to the special note and the risk factors section regarding forward-looking statements in our quarterly report on Form 10-Q filed today with the SEC and the risk factors section of our most recent annual report on Form 10-K. With that, I'll turn the call over to Chairman and CEO of Omeros, Dr. Greg Demopolis.

Speaker #3: Good afternoon and thank you for joining us. Before we begin, I'd like to remind you that certain statements made during this call are forward-looking.

We continue to work collaboratively with FDA, our objective is to expedite the review and potential approval process.

Speaker #3: These statements reflect management's current beliefs and expectations as of today and are subject to change. Forward-looking statements involve risks and uncertainties that could cause actual results to differ materially.

To date results of all requested analyses.

Have been shown.

Speaker #3: For a discussion of these risks and uncertainties, please refer to the special note and the risk factors section regarding forward-looking statements in our quarterly report on Form 10-Q filed today with the SEC.

To be statistically significant.

And are consistent with and supportive of our supplemental benefits as demonstrated in our BLA resubmission.

Speaker #3: And the risk factors section of our most recent annual report on Form 10-K. With that, I'll turn the call over to Chairman and CEO of Omeros, Dr. Greg Demopulos.

Assuming no major deficiencies are identified during its review FDA has indicated that labeling discussions are planned to begin <unk>.

Gregory Demopulos: Thank you, Jennifer, and good afternoon, everyone. Joining me today are David Borges, our Chief Accounting Officer; Nadia Dak, Chief Commercial Officer; Dr. Andreas Grauer, Chief Medical Officer; Dr. Kathy Melty.

Speaker #4: Thank you, Jennifer, and good afternoon, everyone. Joining me today, our David Borges, our Chief Accounting Officer, Nadia Duck, Chief Commercial Officer, Dr. Andreas Grauer, Chief Medical Officer, Dr. Cathy Melfi.

No later than October 2025.

In June we submitted our marketing authorization application or MAA.

For <unk> to the European Medicines agency.

The MAA has been validated initiating formal review process by the committee for medicinal products for human use.

David Borges: Hello, ladies and gentlemen. Please stand by. Your conference call will resume momentarily. Once again, ladies and gentlemen, please stay on the line. Your conference call will resume momentarily. Again, ladies and gentlemen, please stand by. Your conference call will resume momentarily. Once again, ladies and gentlemen, please stay on the line. Again, ladies and gentlemen, please stand by. Your conference call will- Hello, ladies and gentlemen. We thank you for your patience. We do apologize. This is a notified conferencing problem. I'd like to turn the call over to Jennifer Williams for the safe harbor. Please go ahead, ma'am.

Speaker #2: Hello, ladies and gentlemen. Please stand by. Conference call or resume momentarily. Once again, ladies and gentlemen, please stay on the line. Your conference call or resume momentarily.

We expect the decision on the MAA in mid 2026.

We continue to expect that in our thoughtful amount will be the first approved therapy for Ta TMA and that it is well positioned to address a substantial market opportunity.

Awareness is growing among transplant physicians regarding the risks of C. Five inhibitors like <unk> and Raviolis momentum, which are often used off label in Ta TMA and have been shown to be associated with increased infection rates and.

Speaker #2: Again, ladies and gentlemen, please stand by. Your conference call will resume momentarily. Once again, ladies and gentlemen, please stay on the line. Again, ladies and gentlemen, please stand by.

A related complications.

A retrospective single Center case control study published last month in the American Journal of Hematology.

And that pediatric Ta TMA patients treated with the C five inhibitor <unk>.

At significantly higher infection rates compare two well matched controls.

Specifically in the <unk> treated group.

Victor EMEA.

Was eight fold higher.

And one year infection related mortality was six fold higher.

Similar findings are being reported in adults.

Mechanistically <unk> inhibitors, <unk> inhibitors block the infection fighting lytic arm of the classical pathway of complement.

Markedly increasing risk of infection and death and immuno compromised patients in contrast by targeting and inhibiting mast two.

And our thoughtful of map preserves the classical pathways lytic function and the adaptive immune response.

We believe both safety and efficacy will be key differentiators and drivers of adoption for in our supplement.

Speaker #2: Ladies and gentlemen, we thank you for your patience. We do apologize. This is a notified conferencing problem. I'd like to turn the call over to Jennifer Williams for the Safe Harbor.

Two manuscripts will soon be published in Premier peer reviewed journals detailing our thoughtful amass safety and survival benefits in high risk Ta TMA patients the first already accepted for publication.

<unk> survival in both adults and children treated under expanded access.

The second is under review and compares in our supplemental treated adults in both the pivotal trial and in the expanded access program to a well matched external control.

Thanks to the continued efforts of our field based market development and access teams, we are well positioned to drive demand in our highest priority transplant centers upon approval.

These centers are already actively monitor or signs and symptoms of Ta TMA and are familiar with in our supplement and its clinical profile.

We're executing a phased onboarding of hematology experienced sales professionals, who first will target the highest volume transplant centers expanding more broadly over time.

Our sales leadership is currently in active discussions with top tier candidates with deep expertise in transplant and rare hematologic diseases.

Notably many have been closely following our thoughtful and maps development and are genuinely enthusiastic to launch a product that can significantly improve outcomes and save patients' lives.

In parallel we are engaging a hospital decision makers and payers through preapproval information exchanges to support planning for coverage and reimbursement.

Feedback has been highly encouraging.

Stakeholders recognize the strong clinical safety and efficacy data for in our supplement and are eager for an approved treatment option that avoids the risks associated with off label <unk> inhibitors.

Upon approval, we will leverage our experienced field marketing team and a highly skilled sales force to drive rapid uptake.

By emphasizing the compelling clinical data and proactively addressing access barriers, we're confident in our ability to deliver.

Successful launch.

And life saving outcomes to Ta TMA patients and their families.

Looking to the rest of our mast two inhibitor family Oems $10 29 hour long acting once quarterly <unk> two antibody is ready to restart phase III clinical trial activities.

<unk> resources are available.

We have adequate supply of LMS, $10, 29, and matched placebo to support the phase III program.

Our orally administered small molecule <unk> inhibitor program is nearly ready to begin IND, enabling studies.

Both programs target indications suited to their respective delivery modes and pharmacologic profiles.

Turning to our mass III inhibitor program.

Now I'll turn a bar also known as <unk> 906.

Our phase III asset in lead match three antibody.

<unk> III is the key activator on most proximal target in the alternative pathway of complement.

The initial indication is paroxysmal nocturnal hemoglobinuria or <unk>.

The global <unk> market is projected to grow at 11% annually, reaching over $10 billion by 2032.

The complement inhibitor segment alone is expected to more than double from $2 2 billion today to $4 7 billion.

Over the next seven years.

We believe the solid tenant Bart can carve out a significant share in this growing market.

Phase III studies of <unk> have shown efficacy at least equivalent to that of any other alternative pathway targeting agent on the market or in development.

So all panel barge differentiators include.

Once every two months to once quarterly dosing improved.

Compliance and reduce the risk of life threatening breakthrough disease.

No safety signals of concern observed in preclinical or clinical studies.

The phase III program was Pos to prioritize in our supplement of approval and market launch and is set to restart when capital is available.

The potential indications for <unk> are broad.

The market opportunity is substantial.

Let's now look at our programs beyond our complement franchise, our <unk> seven inhibitor program is evaluating on those five to seven.

Speaker #2: Please go ahead, ma'am.

Jennifer Williams: Good afternoon and thank you for joining us or speaking with us. Before we begin, I'd like to remind you that certain statements made during this call are forward-looking. These statements reflect management's current beliefs and expectations as of today and are subject to change. Forward-looking statements involve risks and uncertainties that could cause actual results to differ materially. For a discussion of these risks and uncertainties, please refer to the special note and the risk factors section regarding forward-looking statements in our quarterly report on Form 10-Q filed today with the SEC and the risk factors section of our most recent annual report on Form 10-K. With that, I'll turn the call over to Chairman and CEO of Omeros, Dr. Greg Demopolis.

Speaker #3: Good Good afternoon and thank you for joining us or sticking with us. Before we begin, I'd like to remind you that certain statements made during this call are forward-looking.

For cocaine use disorder or C U D.

Speaker #3: These statements reflect management's current beliefs and expectations as of today and are subject to change. Forward-looking statements involve risks and uncertainties that could cause actual results to differ materially.

Fully funded by a grant from the National Institute on drug abuse or neither.

Preclinical studies designed by ignited toxicologists have been successfully completed with no safety findings and provide the drug interaction safety data in support of a planned inpatient human study of five to seven.

Speaker #3: For a discussion of these risks and uncertainties, please refer to the special note and the risk factors section regarding forward-looking statements in our quarterly report on Form 10-Q filed today with the SEC.

Speaker #3: And the risk factors section of our most recent annual report on Form 10-K. With that, I'll turn the call over to Chairman and CEO of Omeros, Dr. Greg Demopulos.

Cocaine users.

FDA has requested additional preclinical information before initiating the inpatient trial, which we target for the first part of 2026.

Gregory Demopulos: Thank you, Jennifer, and good afternoon, everyone. Joining me today are David Borges, our Chief Accounting Officer; Nadia Dak, Chief Commercial Officer; Dr. Andreas Grauer, Chief Medical Officer; Dr. Kathy Melty, Chief Regulatory Officer; and Dr. Steve Whitaker, Vice President of Clinical. I'll begin with an overview of our second quarter 2025 financial results and provide updates across our development programs. David will then walk through the financials in more detail and will open the call for questions. Our net loss for the second quarter of 2025 was $25.4 million or 43 cents per share, compared to a net loss of $33.5 million or 58 cents per share in the first quarter of this year. As of June 30, 2025, we had $28.7 million in cash and investments. This was further strengthened by a registered direct offering completed on July 28, 2025, which raised $20.6 million in net proceeds.

Speaker #4: Thank you, Jennifer, and good afternoon, everyone. Joining me today are David Borges, our Chief Accounting Officer, Nadia Duck, Chief Commercial Officer, Dr. Andreas Grauer, Chief Medical Officer, Dr. Cathy Melfi, Chief Regulatory Officer, and Dr. Steve Whitaker, Vice President of Clinical.

We're also advancing our oncology platform, including IND, enabling studies for our <unk> Biologics program.

The lead indication is acute myeloid leukemia or AML.

Speaker #4: I'll begin with an overview of our second quarter 2025 financial results. And provide updates across our development programs. David will then walk through the financials in more detail, and we'll open the call for questions.

Sure <unk> AML therapeutic has consistently demonstrated superior efficacy to.

Current AML standard of care treatments both in vivo.

In immunocompromised mice with human tumors and in vitro with human cell lines.

Speaker #4: Our net loss for the second quarter of 2025 was $25.4 million, or $0.43 per share, compared to a net loss of $33.5 million, or $0.58 per share, in the first quarter of this year.

The lead candidate therapeutic shows broad applicability across AML, regardless of genetic mutations.

Other that'd be T. P 53, NPM, one Kmt two way or flit three.

We aim to enter the clinic with an 18 to 24 months guided by our distinguished clinical steering committee composed of world leaders in AML treatment and research.

Speaker #4: As of June 30, 2025, we had 28.7 million dollars in cash and investments. This was further strengthened by a registered direct offering completed on July 28th, 2025, which raised 20.6 million dollars in net proceeds.

I'll now turn the call over to Dave <unk>, Our Chief Accounting officer to go through.

More detailed discussion of our financial results David Thanks, Greg.

Gregory Demopulos: During the quarter, we took decisive steps to strengthen our balance sheet and extend our debt maturity profile. Through a combination of convertible note exchanges and equity conversions, we reduced the outstanding principal on our 2026 notes from $98 million to $17 million, eliminated a $20 million mandatory prepayment on our term loan, and extended the large majority of our debt out to 2029. These actions, including the July offering with Polar Asset Management Partners, reduced our near-term payment obligations by over $100 million. This further positions us to focus capital on advancing key programs and supporting the anticipated launch of NurSupplement. We've removed a major structural overhang, streamlined our balance sheet, and are now better positioned to access additional capital through partnerships, equity, or debt offerings, or sales under our active ATM facility.

Speaker #4: During the quarter, we took decisive steps to strengthen our balance sheet and extend our debt maturity profile. Through a combination of convertible note exchanges and equity conversions, we reduced the outstanding principal on our 2026 notes from $98 million to $17 million.

Our net loss for the quarter of 2025 was $25 4 million or <unk> 43 per share compared to a net loss of $33 5 million or <unk> 58 per share in the first quarter of this year.

As of June 32025, we had $28 $7 million of cash and investments on hand, and as Greg mentioned, we closed a registered direct offering on July 28, and which we received net proceeds of $26 million.

Speaker #4: Eliminated a 20 million dollar mandatory prepayment on our term loan, and extended the large majority of our debt out to 2029. These actions included the July offering with Polar Asset Management Partners, reduced our near-term payment obligations by over 100 million dollars, this further positions us to focus capital on advancing key programs and supporting the anticipated launch of Nur-Supplement.

As we noted in our May 13 conference call, we entered into an exchange agreement with certain holders of our 2026 convertible notes, we exchanged $78 million in aggregate principal amount of our 2026 convertible notes on a one for one basis for newly issued convertible senior.

Our new <unk> and <unk>.

2029.

Speaker #4: We've removed a major structural overhang, streamlined our balance sheet, and are now better positioned to access additional capital through partnerships, equity or debt offerings, or sales under our active ATM facility.

In addition, we reached an agreement with two holders to convert $10 million of there in 2026 notes into shares of the company's stock in three tranches over a 90 day period with the conversion to be finalized by mid September 2025.

Gregory Demopulos: As previously disclosed, we're in discussions regarding potential asset acquisition and/or licensing agreements involving certain of our clinical assets. The most advanced of these discussions is driving toward a multi-billion dollar transaction exclusive of royalties. Upon closing, we expect to receive an upfront cash payment sufficient to repay, in full, the $67.1 million term loan outstanding under our senior secured credit facility, repay at maturity the remaining $17.1 million principal balance of our 2026 convertible notes, and provide sufficient capital for over 12 months of post-closing operations. This transaction is also expected to include near and longer-term milestones and, if regulatory approval is obtained, sales-based milestones and royalties. Let's now turn to the anticipated approval and launch of NurSupplement, our proprietary human monoclonal antibody against MASK2, the key activator of the lectin pathway of complements.

Speaker #4: As previously disclosed, we're in discussions regarding potential asset acquisition and/or licensing agreements involving certain of our clinical assets. The most advanced of these discussions is driving toward a multi-billion dollar transaction, exclusive of royalties.

Following these transactions the outstanding principal balance of our 2026 notes has been reduced from $97 9 million to $17 1 million.

Most importantly, this reduction in principal of the notes enabled the company to avoid making a $20 million mandatory prepayments under our term loan agreement, which otherwise would have been required on or before November one 2025.

Speaker #4: Upon closing, we expect to receive an upfront cash payment sufficient to repay in full the $67.1 million term loan outstanding, under our senior secured credit facility, repay it maturity the remaining $17.1 million principal balance of our 2026 convertible notes, and provide sufficient capital for over 12 months of post-closing operations.

These transactions significantly pushed out debt maturities with only $17 1 million of debt due within the next 12 months.

And recall that we entered into a capped call transaction in connection with the issuance of the 'twenty to 'twenty six notes to reduce potential dilution or cash outlay upon conversion.

Even with the outstanding balance of the 'twenty six notes down to $17 1 million, we've retained the full potential value of the cap column up to $92 6 million.

Speaker #4: This transaction is also expected to include near- and longer-term milestones and, if regulatory approval is obtained, sales-based milestones and royalties. Let's now turn to the anticipated approval and launch of Nur-Supplement, our proprietary human monoclonal antibody against MASK2, the key activator of the lectin pathway of complement.

Cost and expenses from continuing operations for the second quarter before interest and other income were $32 4 million, which was a decrease of $2 6 million from the first quarter of this year.

Research and development expenses in the second quarter were primarily focused on <unk> and there is some momentum.

[laughter].

Gregory Demopulos: While we've identified several commercially attractive follow-on indications for NurSupplement, the initial indication is stem cell transplant-associated thrombotic microangiopathy, or TATMA, a life-threatening complication of stem cell transplant. In March, we resubmitted our biologic license application, or BLA, for NurSupplement in TATMA. The FDA accepted the submission for review and assigned a PDUFA target action date of September 25th, following our submission of additional information requested by FDA. The agency extended the PDUFA date to December 26th. We continue to work collaboratively with FDA. Our objective is to expedite the review and potential approval process. To date, results of all requested analyses have been shown to be statistically significant and are consistent with and supportive of NurSupplement's benefits, as demonstrated in our BLA resubmission. Assuming no major deficiencies are identified during its review, FDA has indicated that labeling discussions are planned to begin no later than October 2025.

Speaker #4: While we've identified several commercially attractive follow-on indications for Nur-Supplement, the initial indication is stem cell transplant associated thrombotic microangiopathy, or TATMA, a life-threatening complication of stem cell transplant.

The primary components of interest expense include the 2026 notes the <unk> and <unk> royalty obligation the secured term loan and the 2029 notes for the second quarter interest expense was near zero, primarily due to an $8 5 million noncash remeasurement adjustment related to.

Our DIY imagery net royalty obligations.

Speaker #4: In March, we resubmitted our biologic license application, or BLA, for Nur-Supplement in TATMA. The FDA accepted the submission for review, and assigned a PADUFA target action date of September 25th.

This adjustment reflects updated forecast of royalty receipts provided by <unk>.

Excluding the <unk> the.

<unk> royalty obligation, which is entirely pass through interest from <unk> to <unk>.

And amortization of debt issuance cost debt discounts and premiums contractual cash interest expense was $3 9 million compared.

Speaker #4: Following our submission of additional information requested by the FDA, the agency extended the PDUFA date to December 26th. We continued to work collaboratively with the FDA; our objective is to expedite the review and potential approval process.

Compared to $3 7 million in the prior quarter.

The increase was due to the higher interest on a 2029 notes relative to the 'twenty six notes.

Interest and other income totaled $1 2 million in the second quarter compared to $1 1 million in the first quarter of this year.

Speaker #4: To date, results of all requested analyses have been shown to be statistically significant and are consistent with and supportive of Nur-Supplement's benefits, as demonstrated in our BLA resubmission.

During the second quarter, we reported an $8 2 million noncash gain on marking to market our financial instruments. Our financial instruments are comprised of a derivative liability on our 2029 notes representing the ability of holders to convert their notes to equity.

Speaker #4: Assuming no major deficiencies are identified during its review, the FDA has indicated that labeling discussions are planned to begin no later than October 2025. In June, we submitted our marketing authorization application, or MAA, for Nur-Supplement in TATMA to the European Medicines Agency.

<unk> of our 2029 notes at June 32025 resulted in a noncash gain of $8 million.

Income from discontinued operations in the second quarter was $465000 a decrease of $3 6 million from the first quarter.

Gregory Demopulos: In June, we submitted our marketing authorization application, or MAA, for NurSupplement in TATMA to the European Medicines Agency. The MAA has been validated, initiating a formal review process by the Committee for Medicinal Products for Human Use. We expect a decision on the MAA in mid-2026. We continue to expect that NurSupplement will be the first approved therapy for TATMA and that it is well-positioned to address a substantial market opportunity. Awareness is growing among transplant physicians regarding the risks of C5 inhibitors like eculizumab and ravulizumab, which are often used off-label in TATMA and have been shown to be associated with increased infection rates and related complications. A retrospective single-center case control study published last month in the American Journal of Hematology found that pediatric TATMA patients treated with the C5 inhibitor eculizumab had significantly higher infection rates compared to well-matched controls.

This decline was primarily due to a remeasurement adjustment stemming from Rainer as Jan word revision of its forecast for U S based royalties.

Speaker #4: The MAA has been validated, initiating formal review process by the committee for medicinal products for human use. We expect the decision on the MAA in mid-2026.

As a result, we are required under GAAP to revised downward our imagery to contact royalty assets and <unk> and need to be a royalty obligation.

It is important to note that the bulk of these transactions involve usp's royalties, which are pass through in nature.

Speaker #4: We continue to expect that Nur-Supplement will be the first approved therapy for TATMA and that it is well-positioned to address a substantial market opportunity.

<unk> royalties D rvs, the Cri and escrow agent, however, because both <unk> and <unk> are contractual counterparties to us we're required to recognize these amounts as assets and liabilities on our balance sheet.

Speaker #4: Awareness is growing among transplant physicians regarding the risks of C5 inhibitors like echelizumab and rabelizumab, which are often used off-label in TATMA and have been shown to be associated with increased infection rates, and related complications.

As a reminder, in February 2024, we amended our agreement with DIY granting them rights to all U S. Omidria royalties for Marina through December 31, 2031.

The mirrorless retains royalties from ex U S sales and will receive all global and majority of royalty starting January one 2032.

Speaker #4: A retrospective single-center case-control study published last month in the American Journal of Hematology found that pediatric TATMA patients treated with the C5 inhibitor echelizumab had significantly higher infection rates compared to well-matched controls.

Now, let's look at our expected third quarter 2025 results.

We anticipate that overall operating expenses from continuing operations in the third quarter of 2025 will be lower than in the second quarter, primarily due to reduced spending on clinical development. It was all 10 of our decreased activity across certain other development programs and other cost reduction efforts.

Gregory Demopulos: Specifically, in the eculizumab-treated group, bacteremia was eight and a half-fold higher, and one-year infection-related mortality was six-fold higher. Similar findings are being reported in adults. Mechanistically, C5 inhibitors like C3 inhibitors block the infection-fighting lytic arm of the classical pathway of complement, markedly increasing the risk of infection and death in immunocompromised patients. In contrast, by targeting and inhibiting MASK2, NurSupplement preserves the classical pathway's lytic function and the adaptive immune response. We believe both safety and efficacy will be key differentiators and drivers of adoption for NurSupplement. Two manuscripts will soon be published in premier peer-reviewed journals detailing NurSupplement's safety and survival benefits in high-risk TATMA patients. The first, already accepted for publication, assesses survival in both adults and children treated under expanded access.

Speaker #4: Specifically, in the echelizumab-treated group, bacteremia was 8.5-fold higher, and one-year infection-related mortality was six-fold higher. Similar findings are being reported in adults. Mechanistically, C5 inhibitors like C3 inhibitors block the infection-fighting lytic arm of the classical pathway of complement, markedly increasing risk of infection and death in immunocompromised patients.

Interest and other income for the third quarter is expected to be comparable to the second quarter.

Interest expense, excluding any noncash adjustments related to the imagery of royalty obligation and that derivative revaluations should be around $92 million.

This represents a noncash increase of $9 3 million from the second quarter, primarily reflecting the absence of a significant noncash adjustment tied to the omidria royalty obligations as well as an incremental $500000 in cash interest associated with the newly issued 2029 convertible notes.

Speaker #4: In contrast, by targeting and inhibiting MASK2, Nur-Supplement preserves the classical pathway's lytic function and the adaptive immune response. We believe both safety and efficacy will be key differentiators and drivers of adoption for Nur-Supplement.

And finally income from discontinued operations is expected to be in the $5 million to $7 million range, excluding any noncash remeasurement adjustments to the omidria contract asset.

With that I'll turn the call back over to Greg.

Thank you David operator, let's now please open the call to questions.

Speaker #4: Two manuscripts will soon be published in premier peer-reviewed journals detailing Nur-Supplement's safety and survival benefits in high-risk TATMA patients. The first, already accepted for publication, assesses survival in both adults and children treated under expanded access.

Thank you ladies and gentlemen, if you have a question or comment at this time. Please press star one on your telephone. If your question has been answered or you were seeing with yourself from the queue. Please press star one again, we will pause for a moment, while we compile the Q&A roster.

Gregory Demopulos: The second is under review and compares NurSupplement-treated adults in both the pivotal trial and in the expanded access program to a well-matched external control. Thanks to the continued efforts of our field-based market development and access teams, we're well-positioned to drive demand in our highest priority transplant centers upon approval. These centers are already actively monitoring for signs and symptoms of TATMA and are familiar with NurSupplement and its clinical profile. We're executing a phased onboarding of hematology experienced sales professionals who first will target the highest volume transplant centers, expanding more broadly over time. Our sales leadership is currently in active discussions with top-tier candidates with deep expertise in transplant and rare hematologic diseases. Notably, many have been closely following NurSupplement's development and are genuinely enthusiastic to launch a product that can significantly improve outcomes and save patients' lives.

Speaker #4: The second is under review and compares Nur-Supplement-treated adults in both the pivotal trial and in the expanded access program to a well-matched external control.

Our first question comes from Steve Brozak with Wpb's W. BB Securities. Your line is open.

Hey, good afternoon, and thank you for the update.

Really wanted to go over the financial modeling.

Speaker #4: Thanks to the continued efforts of our field-based market development and access teams, we're well-positioned to drive demand in our highest priority transplant center upon approval.

Bob and I would like to compare it if you don't mind you launched a product in the past obviously, it's been a while omidria and you've got about $1 billion plus in revenue on that product.

Speaker #4: These centers are already actively monitored for signs and symptoms of TATMA and are familiar with Nur-Supplement and its clinical profile. We're executing a phased onboarding of hematology-experienced sales professionals who first will target the highest volume transplant centers, expanding more broadly over time.

More at.

At the end of the day.

How does that launch compared to what you're preparing for.

You can go into as much details you'd like can I have one follow up after that thanks.

Okay.

Thanks, Dave.

We have not.

Delivered a lot of information publicly about our planned launch projections around the launch what I can tell you.

Speaker #4: Our sales leadership is currently in active discussions with top-tier candidates with deep expertise in transplant and rare hematologic diseases. Notably, many have been closely following Nur-Supplement's development and are genuinely enthusiastic to launch a product that can significantly improve outcomes and save patients' lives.

Is that it is a significantly more focused market than what we had with omidria with Omidria, we were targeting cataract surgeons of which there are a good number a large number nationally.

With.

Gregory Demopulos: In parallel, we're engaging hospital decision-makers and payers through pre-approval information exchanges to support planning for coverage and reimbursement. Feedback has been highly encouraging. Stakeholders recognize the strong clinical safety and efficacy data for NurSupplement and are eager for an approved treatment option that avoids the risks associated with off-label C5 inhibitors. Upon approval, we will leverage our experienced field marketing team and a highly skilled sales force to drive rapid uptake. By emphasizing the compelling clinical data and proactively addressing access barriers, we're confident in our ability to deliver a successful launch and life-saving outcomes to TATMA patients and their families. Looking to the rest of our MASK2 inhibitor family, OMS-1029, our long-acting once-quarterly MASK2 antibody, is ready to restart phase two clinical trial activities once resources are available. We have adequate supply of OMS-1029 and matched placebo to support the phase two program.

Ta TMA as the indication.

Speaker #4: In parallel, we're engaging hospital decision-makers and payers through pre-approval information exchanges to support planning for coverage and reimbursement. Feedback has been highly encouraging. Stakeholders recognize the strong clinical safety and efficacy data for Nur-Supplement and are eager for an approved treatment option that avoids the risks associated with off-label C5 inhibitors.

<unk> plants are done and 175 centers.

Across the nation so the.

Number of on the ground.

Sales people.

Is significantly less than what we needed for omidria.

So that is clearly an advantage we see the market opportunity, obviously as large I think others do as well, which is why there have been others in development for Ta TMA.

Speaker #4: Upon approval, we will leverage our experienced field marketing team and a highly skilled sales force to drive rapid uptake. By emphasizing the compelling clinical data and proactively addressing access barriers, we're confident in our ability to deliver a successful launch and lifesaving outcomes to TATMA patients and their families.

I think with with respect to specific numbers pricing launch projections any of that information, we're going to beg off for that right now Steve.

Just not the appropriate time I think to go through that but.

No that we clearly are.

Working through how to optimize the launch and make sure that with our soft pull them out.

Speaker #4: Looking to the rest of our MASK2 inhibitor family, OMS 1029, our long-acting once-quarterly MASK2 antibody, is ready to restart phase two clinical trial activities once resources are available.

Once approved that we are able to reach as many physicians and patients both in the U S and ex U S.

That weekend.

Speaker #4: We have an adequate supply of OMS 1029 and matched placebo to support the Phase 2 program. Our orally administered small molecule MASK2 inhibitor program is nearly ready to begin I&D enabling studies.

We're very confident.

In the.

Okay.

Got it okay.

Gregory Demopulos: Our orally administered small molecule MASK2 inhibitor program is nearly ready to begin IND-enabling studies. Both programs target indications suited to their respective delivery modes and pharmacologic profiles. Turning to our MASK3 inhibitor program, zoltenibar, also known as OMS-906, is our phase three asset and lead MASK3 antibody. MASK3 is the key activator and most proximal target in the alternative pathway of complement. The initial indication is paroxysmal nocturnal hemoglobinuria or PNH. The global PNH market is projected to grow at 11% annually, reaching over $10 billion by 2032. The complement inhibitor segment alone is expected to more than double, from 2.2 billion today to 4.7 billion over the next seven years. We believe zoltenibar can carve out a significant share in this growing market.

Me too.

Sure.

Patient.

<unk> are very very carefully.

Okay.

Can you hear me now.

Speaker #4: Both programs target indications suited to their respective delivery modes and pharmacologic profiles. Turning to our MASK3 inhibitor program, Zaltenabar, also known as OMS 906, is our Phase 3 asset and lead MASK3 antibody.

Okay. Let me, let me dive right in the patient population you're talking about right now is very very clear and they've also had extra.

Extraordinary expenses.

Okay.

They are in their treatment process up until the Ta TMA.

How comfortable are the clinicians that you talk to or.

Speaker #4: MASK3 is the key activator and most proximal target in the alternative pathway of complement. The initial indication is paroxysmal nocturnal hemoglobinuria, or PNH. The global PNH market is projected to grow at 11% annually, reaching over $10 billion by 2032.

Alright.

So far in saying, yes. They want this product and it is clearly something that is needed on an urgent basis and I'll hop back into queue. Thank you.

My my take on that is that these physicians are eagerly awaiting the.

The approval of our supplement, but let me hand that over to <unk>, who I think can give you more detailed information on the response from physicians not yet.

Speaker #4: The complement inhibitor segment alone is expected to more than double from 2.2 billion today to 4.7 billion over the next seven years. We believe Zaltenabar can carve out a significant share in this growing market.

Yes, Thanks, Greg.

It's really.

You have to get response from physicians about the need for nurse Poplar Mab you can imagine you just.

Commented on it that these.

Patients have been through so much Jeff.

Gregory Demopulos: Phase two studies of zoltenibar and PNH have shown efficacy at least equivalent to that of any other alternative pathway targeting agent on the market or in development. Zoltenibar's differentiators include once every two months to once-quarterly dosing, improved compliance, and reduced risk of life-threatening breakthrough disease, and no safety signals of concern observed in preclinical or clinical studies. The phase three program was paused to prioritize NurSupplement approval and market launch and is set to restart when capital is available. The potential indications for zoltenibar are broad, and the market opportunity is substantial. Let's now look at our programs beyond our complement franchise. Our PDE7 inhibitor program is evaluating OMS-527 for cocaine use disorder, or CUD, fully funded by a grant from the National Institute on Drug Abuse, or NIDA.

Speaker #4: Phase two studies of Zaltenabar and PNH have shown efficacy at least equivalent to that of any other alternative pathway targeting agent on the market or in development.

On this journey with transplant.

And to be near.

Nearing getting out of the wood and then having a lethal complication.

Is absolutely not what the physicians or the patients would want and till they see this as a much needed solution.

Speaker #4: Zaltenabar's differentiators include once-every-two-months-to-once-quarterly dosing, improved compliance and reduced risk of life-threatening breakthrough disease, and no safety signals of concern observed in preclinical or clinical studies.

The fact that it is it would be indicated the first and only <unk>.

In terms of those that have had response already attunity expanded access program.

They are eager to have this approved.

Speaker #4: The phase three program was paused to prioritize Nur-Supplement approval and market launch and is set to restart when capital is available. The potential indications for Zaltenabar are broad, and the market opportunity is substantial.

Be able Q2.

50 patients.

To avoid these kinds of complication.

Got it that answers the question Steve.

I think if there is any if there's any bright side to the length of time, we've been waiting to get in there is thoughtful and <unk> approved in <unk>.

Speaker #4: Let's now look at our program's beyond-our-complement franchise. Our PDE7 inhibitor program is evaluating OMS 527 for cocaine use disorder, or CUD, fully funded by a grant from the National Institute on Drug Abuse, or NIDA.

Ben the ability for physicians through the expanded access program and obviously through numerous presentations publications to understand the effects of our thoughtful and map the benefits thoughtful and frankly some of the.

Gregory Demopulos: Preclinical studies designed by NIDA toxicologists have been successfully completed with no safety findings and provide the drug interaction safety data in support of the planned inpatient human study of 527 in cocaine users. FDA has requested additional preclinical information before initiating the inpatient trial, which we target for the first part of 2026. We're also advancing our oncology platform, including IND-enabling studies for our Oncotox biologics program. The lead indication is acute myeloid leukemia, or AML. Our Oncotox AML therapeutic has consistently demonstrated superior efficacy to current AML standard-of-care treatments, both in vivo, in immunocompromised mice with human tumors, and in vitro with human cell lines. The lead candidate therapeutic shows broad applicability across AML, regardless of genetic mutations, whether that be TP53 NPM1, KMT2A, or FLT3.

Speaker #4: Preclinical studies designed by NIDA Toxicologists have been successfully completed with no safety findings, and provide the drug interaction safety data in support of the planned inpatient human study of 527 in cocaine users.

The challenges or risks associated with potential competitors in development.

Got it.

Thanks again for the details.

One moment for our next question.

Speaker #4: FDA has requested additional preclinical information before initiating the inpatient trial, which we target for the first part of 2026. We're also advancing our oncology platform, including I&D enabling studies for our Oncotox Biologics program.

Okay.

Our next question comes from Brandon Folkes with H C. Wainwright Your line is open.

Hi.

My questions and congrats guys.

Okay.

Okay.

If you are approved in December.

How long would you anticipate before you could launch the product and then maybe just sort of along the same lines I.

Speaker #4: The lead indication is acute myeloid leukemia, or AML. Our Oncotox AML therapeutic has consistently demonstrated superior efficacy to current AML standard of care treatments, both in vivo, in immunocompromised mice with human tumors, and in vitro with human cell lines.

I think going into the pie.

Uh huh.

Until a couple of years ago, I know you bought a fair amount of inventory. So I'm just thinking if we should be thinking about the same sort of approach this way round in modeling that into R&D spend.

Thank you.

Good question Brandon. Thank you youre, breaking up a bit, but I think I caught it.

We again are are hopeful that we will reach an approval decision before December but using your assumptions that approval were to occur in December we would.

Speaker #4: The lead candidate therapeutic shows broad applicability across AML, regardless of genetic mutations, whether that be TP53, PM1, KMT2A, or FLT3. We aim to enter the clinic within 18 to 24 months, guided by our distinguished clinical steering committee, composed of world leaders in AML treatment and research.

As you understand not be launching in December, but we would be launching than in the first quarter and I think obviously, we are geared up and ready to go with respect to supply we have substantial supply and that is not going to be a challenge in any way.

Gregory Demopulos: We aim to enter the clinic within 18 to 24 months, guided by our distinguished clinical steering committee composed of world leaders in AML treatment and research. I'll now turn the call over to David Borges, our Chief Accounting Officer, to go through a more detailed discussion of our financial results. David?

Speaker #4: I'll now turn the call over to David Borges, our Chief Accounting Officer, to go through a more detailed discussion of our financial results. David?

For us.

<unk> do you have any comments on the launch or David on supply.

David Borges: Thanks, Greg. Our net loss for the quarter of 2025 was $25.4 million, or 43 cents per share, compared to a net loss of $33.5 million, or 58 cents per share in the first quarter of this year. As of June 30, 2025, we had $28.7 million of cash and investments on hand. And as Greg mentioned, we closed a registered direct offering on July 28th, in which we received net proceeds of $20.6 million. As we noted in our May 13th conference call, we entered into an exchange agreement with certain holders of our 2026 convertible notes. We exchanged $70.8 million in aggregate principal amounts of our 2026 convertible notes on a one-for-one basis for newly issued convertible senior notes due in June 2029.

Speaker #2: Thanks, Greg. Our net loss for this quarter of 2025 was 25.4 million dollars, or 43 cents per share compared to a net loss of 33.5 million, or 58 cents per share in the first quarter of this year.

I will build on the launch that's where David comments on the supply.

What we have in place a plan to upon approval immediately train our field.

The team that's in place.

On the <unk>.

Package insert information and they will be deployed immediately.

Speaker #2: As of June 30, 2025, we had 28.7 million dollars of cash and investments on hand, and as Greg mentioned, we closed a registered direct offering on July 28th, in which we received net proceeds of 20.6 million dollars.

Immediately upon certification.

Followed by the sales reps, then that would be on boarded them.

So we will be driving awareness education and demand immediately upon approval and then we have some other things lined up that would be non personnel in terms of digital tools and the other thing to supplement that because we view that says really it's two pronged do we have to continue the education on Ta TMA.

Speaker #2: As we noted in our May 13th conference call, we entered into an exchange agreement with certain holders of our 2026 convertible notes, we exchanged 70.8 million in aggregate principal amount of our 2026 convertible notes, on a one-for-one basis for newly issued convertible senior notes due in June 2029.

Well, then educating on north parcel mab, while the supply prepares to fill the channel as well, David Let me hand, it back to you.

David Borges: In addition, we reached an agreement with two holders to convert $10 million of their 2026 notes into shares of the company's stock in three tranches over a 90-day period, with a conversion to be finalized by mid-September 2025. Following these transactions, the outstanding principal balance of our 2026 notes has been reduced from $97.9 million to $17.1 million. Most importantly, this reduction in principal of the notes enabled the company to avoid making a $20 million mandatory prepayment under our term loan agreement, which otherwise would have been required on or before November 1st, 2025. These transactions significantly pushed out debt maturities with only $17.1 million of debt due within the next 12 months. And recall that we entered into a cap call transaction in connection with the issuance of the 2026 notes to reduce potential dilution or cash outlay upon conversions.

Speaker #2: In addition, we reached an agreement with two holders to convert $10 million of their 2026 notes into shares of the company's stock in three tranches over a 90-day period, with a conversion to be finalized by mid-September 2025.

Yes with respect to supply we have adequate supply for the first several years from launch so I think we're in great shape, there with respect to our inventory.

Okay.

Brendan.

Thank you very much Greg and everyone that answers my question.

Congrats on the pregnancy.

Speaker #2: Following these transactions, the outstanding principal balance of our 2026 notes has been reduced from 97.9 million to 17.1 million dollars, most importantly, this reduction in principal of the notes enabled the company to avoid making a $20 million mandatory prepayment under our term loan agreement, which otherwise would have been required on or before November 1st, 2025.

Thank you.

Number four our next question.

Our next question comes from Olivia Brayer with Cantor Your line is open.

Good afternoon. Thank you for the question Greg can you talk about what the F D. A.

A question that actually led to the three months to just the delay was it additional data from the historical database or.

Or something else and then anything in that request that was maybe unexpected.

Speaker #2: These transactions significantly pushed out debt maturities, with only 17.1 million of debt due within the next 12 months. And recall that we entered into a cap-call transaction in connection with the issuance of the 2026 notes to reduce potential dilution or cash outlay upon conversion.

And I've got one follow up.

Hi, Olivia Thanks for the question. It was really additional analysis there were a number of analyses that were requested.

And frankly, I think it may have been a bit overwhelming the amount of data that we.

David Borges: Even with the outstanding balance of the '26 note down to $17.1 million, we have retained the full potential value of the cap call, up to $92.6 million. Costs and expenses from continuing operations for the second quarter before interest and other income were $32.4 million, which was a decrease of $2.6 million from the first quarter of this year. Research and development expenses in the second quarter were primarily focused on zoltenibars and nurzuplamabin. The primary components of interest expense include the 2026 notes, the DRI mid-year royalty obligation, the secured term loan, and the 2029 notes. For the second quarter, interest expense was near zero, primarily due to an $8.5 million non-cash remeasurement adjustment related to our DRI immediate royalty obligation.

Speaker #2: Even with the outstanding balance of the 26 notes down to $17.1 million, we have retained the full potential value of the cap call, up to $92.6 million.

Subsequently <unk>.

<unk> in response.

So.

That is my view of that Kathy do you want to.

Speaker #2: Cost and expenses from continuing operations for the second quarter before interest and other income for 32.4 million which was a decrease of 2.6 million from the first quarter of this year.

To elaborate.

Yeah again, as Greg said they requested additional analyses.

Currently felt that they could not review it in time to make the emotional and participate and as you know when you get a major amendment.

Speaker #2: Research and development expenses in the second quarter were primarily focused on Zaltenabar and Nur-Supplement. The primary components of interest expense include the 2026 notes, the DRI Midria royalty obligation, the secured term loan, and the 2029 notes.

<unk> standard is X three months onto that that is the date, our continuing to work with FDA and we're hoping as Greg said before we can bring it in.

Even earlier than December.

December 26 date.

The relationship Olivia has been really quite collaborative.

Speaker #2: For the second quarter, interest expense was near zero, primarily due to an $8.5 million non-cash remeasurement adjustment related to our DRI Midria royalty obligation.

I know that there are a number of.

Of issues that are at least finding their way into the press around FDA and recent responsiveness frankly, we have not.

David Borges: This adjustment reflects updated forecast of royalty receipts provided by Raynor, excluding the DRI royalty obligation, which is entirely passed through interest from Raynor to DRI and amortization of debt issuance costs, debt discounts, and premiums. Contractual cash interest expense was $3.9 million compared to $3.7 million in the prior quarter. The increase was due to the higher interest on the 2029 notes relative to the '26 notes. Interest and other income totaled $1.2 million in the second quarter compared to $1.1 million in the first quarter of this year. During the second quarter, we reported an $8.2 million non-cash gain on marketing to market our financial instruments. Our financial instruments are comprised of a derivative liability on our 2029 notes, representing the ability of holders to convert their notes to equity. The remeasurement of our 2029 notes at June 30, 2025, resulted in a non-cash gain of $8 million.

Speaker #2: This adjustment reflects updated forecasts of royalty receipts provided by Ringer, excluding the DRI royalty obligation which is entirely pass-through interest from Ringer to DRI, and amortization of debt issuance costs, debt discounts and premiums, contractual cash interest expense was 3.9 million dollars, compared to 3.7 million in the prior quarter.

Encountered any of that with this division.

The interactions have been responsive and very collaborative so today. That's that's how we have found this process.

Yeah, that's great I'm happy to hear that and hopefully that continues going forward and then can you tell us.

Speaker #2: The increase was due to the higher interest on the 2029 notes relative to the 2026 notes. Interest and other income totaled $1.2 million in the second quarter, compared to $1.1 million in the first quarter of this year.

More about the potential partnership that you're pursuing.

Maybe.

What kind of partnerships and which programs in particular that youre looking to partner out.

Speaker #2: During the second quarter, we reported an 8.2 million dollars non-cash gain on marking-to-market our financial instruments. Our financial instruments are comprised of a derivative liability on our 2029 notes, representing the ability of holders to convert their notes to equity.

Yes.

All I can say on that at this point is that there is substantial interest really across our programs.

And we've outlined.

The parameters of.

One such partnership and as you might imagine we're required to do so as part of our equity financing to make sure that all all material nonpublic information was plans so.

Speaker #2: The remeasurement of our 2029 notes at June 30, 2025, resulted in a non-cash gain of 8 million dollars. Income from discontinued operations in the second quarter was 465 thousand dollars, a decrease of 3.6 million from the first quarter.

David Borges: Income from discontinued operations in the second quarter was $465,000, a decrease of $3.6 million from the first quarter. This decline was primarily due to a remeasurement adjustment stemming from Raynor's downward revision of its forecast for US-based royalties. As a result, we are required to enter GAAP to revise downward our immediate contract royalty asset and DRI immediate royalty obligation. It's important to note that the bulk of these transactions involve US-based royalties, which are passed through in nature. Raynor remits these royalties to DRI via an escrow agent. However, because both Raynor and DRI are contractual counterparties to us, we're required to recognize these amounts as assets and liabilities on our balance sheet. As a reminder, in February 2024, we amended our agreement with DRI, granting them rights to all US immediate royalties from Raynor through December 31, 2031.

Speaker #2: This decline was primarily due to a remeasurement adjustment stemming from Ringer's downward revision of its forecast for US-based royalties. As a result, we are required under GAAP to revise downward our Midria contract royalty asset and DRI Midria royalty obligation.

I think we've said really all that we need.

Hence a ore really will say on that topic at this point.

But I think are.

Referencing it.

By definition means that it is material from our position.

Speaker #2: It's important to note that the bulk of these transactions involve U.S.-based royalties, which are pass-through in nature. Ringer remits these royalties to DRI via an escrow agent.

Okay understood. Thank you very much thanks, Olivia thank you.

And I'm not showing any further questions at this time I would like to turn the call back over to Dr. Kumar for any further remarks.

Speaker #2: However, because both Ringer and DRI are contractual counterparties to us, we're required to recognize these amounts as assets and liabilities on our balance sheet.

Alright, Thank you operator.

Thank you everyone for joining.

This afternoon.

Speaker #2: As a reminder, in February 2024, we amended our agreement with DRI, granting them rights to all US and Midria royalties from Ringer through December 31st, 2031.

We apologize for that initial difficulty with the technical component.

I appreciate the help though that.

David Borges: Omeros retains royalties from ex-US sales and will receive all global immediate royalties starting January 1, 2032. Now let's look at our expected third quarter 2025 results. We anticipate that overall operating expenses from continuing operations in the third quarter of 2025 will be lower than in the second quarter, primarily due to reduced spending on clinical development of zoltenibar, decreased activity across certain other development programs, and other cost reduction efforts. Interest and other income for the third quarter is expected to be comparable to the second quarter. Interest expense, excluding any non-cash adjustments related to the immediate royalty obligation and debt derivative revaluations, should be around $9.2 million.

Speaker #2: Omeros retains royalties from ex-U.S. sales and will receive all global Midria royalties starting on January 1, 2032. Now, let's look at our expected third quarter 2025 results.

Our provider did did put forth to fix the problem quickly. So thank you.

As you can see <unk> has.

A good number of value driving milestones and process.

Speaker #2: We anticipate that overall operating expenses from continuing operations in the third quarter of 2025 will be lower than in the second quarter, primarily due to reduced spending on clinical development of Zaltenabar, decreased activity across certain other development programs, and other cost reduction efforts.

And we look forward to sharing more information with you throughout the remainder of 2025.

All of US on <unk>. Appreciate your continued support and look forward to sharing further updates with you.

Have a good evening.

Speaker #2: Interest and other income for the third quarter is expected to be comparable to the second quarter. Interest expense excluding any non-cash adjustments related to the Midria royalty obligation and debt derivative revaluations should be around 9.2 million dollars.

Thank you ladies and gentlemen, this does conclude today's presentation. We do thank you for your participation and you may now disconnect and have a wonderful day.

David Borges: This represents a non-cash increase of $9.3 million from the second quarter, primarily reflecting the absence of a significant non-cash adjustment tied to the immediate royalty obligation, as well as an incremental $500,000 in cash interest associated with the newly issued 2029 convertible notes. And finally, income from discontinued operations is expected to be in the $5 to $7 million range, excluding any non-cash remeasurement adjustments to the immediate contract asset. With that, I'll turn the call back over to Greg. Thank you, David. Operator, let's now please open the call to questions. Thank you, ladies and gentlemen. If you have a question or a comment at this time, please press star one-one on your telephone. If your question has been answered or you wish to move yourself from the queue, please press star one-one again. We'll pause for a moment while we compile our Q&A roster.

Speaker #2: This represents a non-cash increase of 9.3 million from the second quarter, primarily reflecting the absence of a significant non-cash adjustment tied to the Midria royalty obligation, as well as an incremental 500 thousand dollars in cash interest associated with the newly issued 2029 convertible notes.

Speaker #2: And finally, income from discontinued operations is expected to be in the 5 to 7 million dollar range, excluding any non-cash remeasurement adjustments to the Midria contract asset.

Speaker #2: With that, I'll turn the call back over to Greg.

Speaker #4: Thank you, David. Operator, let's now please open the call to questions.

Speaker #2: Thank you, ladies and gentlemen. If you have a question or a comment at this time, please press star one-one on your telephone. If your question has been answered or you wish to move yourself from the queue, please press star one-one again.

Speaker #2: We'll pause for a moment while we compile our Q&A roster. Our first question comes from Steve Brozak with WBB Securities. Your line is open.

David Borges: Our first question comes from Steve Brozak with WBB Securities. Your line is open.

Steve Brozak: Hey, good afternoon, and thanks for the update. I really want to go over the financial modeling of NurSupplement, and I'd like to compare it, if you don't mind. You launched a product in the past, obviously it's been a while, Omidria, and you got about a billion dollars plus in revenue on that product, more at the end of the day. How does that launch compare to what you're preparing for? You know, you can go in as much detail as you like, and I have one follow-up after that. Thanks.

Speaker #5: Hey, good afternoon and thanks for the update. I really want to go over the financial modeling of Nur-Supplement, and I'd like to compare it, if you don't mind, you've launched a product in the past, obviously it's been a while, Omnidria, and you've got about a billion dollars plus in revenue on that product more at the end of the day.

Speaker #5: How does that launch compare to what you're preparing for? You know, you can go into as much detail as you like, and I have one follow-up after that. Thanks.

Gregory Demopulos: Okay. Thanks, Steve. We have not delivered a lot of information publicly about our planned launch projections around the launch. What I can tell you is that it is a significantly more focused market than what we had with Omidria. With Omidria, we were targeting cataract surgeons, of which there are a good number, a large number nationally. With TATMA as the indication, transplants are done in 175 centers across the nation. So the number of on-the-ground sales people is significantly less than what we needed for Omidria. So that is clearly an advantage. We see the market opportunity, obviously, as large. I think others do as well, which is why there have been others in development for TATMA. But I think with respect to specific numbers, pricing, launch projections, any of that information, we're going to beg off for that right now, Steve.

Speaker #4: Okay. Thanks, Steve. We have not delivered a lot of information publicly about our planned launch projections around the launch. What I can tell you is that it is a significantly more focused market than what we had with Omnidria.

Speaker #4: With Omnidria, we were targeting cataract surgeons, of which there are a good number— a large number, nationally. With TATMA, as the indication, transplants are done in 175 centers across the nation, so the number of on-the-ground salespeople is significantly less than what we needed for Omnidria.

Speaker #4: So, that is clearly an advantage. We see the market opportunity, obviously, as large. I think others do as well, which is why there have been others in development for TATMA.

Speaker #4: But I think with respect to specific numbers, pricing, launch projections, any of that information we're going to beg of for that right now, Steve.

Gregory Demopulos: It's just not the appropriate time, I think, to go through that. But know that we clearly are working through how to optimize the launch and make sure that with NurSupplement, once approved, that we are able to reach as many physicians and patients, both in the US and ex-US, that we can. We're very confident in.

Speaker #4: It's just not the appropriate time, I think, to go through that, but know that we clearly are working through how to optimize the launch and make sure that with Nur-Supplement, once approved, that we are able to reach as many physicians and patients, both in the US and ex-US, that we can.

Speaker #4: We're very confident in the.

Steve Brozak: Got it. Okay. That leads me to patient population that are very, very sick.

Speaker #5: Got Got it. Okay. That leads me to a patient about our very, very sick operation.

Gregory Demopulos: Give me a break.

Steve Brozak: And.

Gregory Demopulos: Can you hear me now?

Speaker #2: Can you hear me now?

Steve Brozak: I can now.

Speaker #4: I can now.

Gregory Demopulos: Hello?

Speaker #5: Hello?

Steve Brozak: Okay. Let me dive right in. The patient population you're talking about right now is very, very sick. And they've also had extraordinary expenses paid for their treatment process up until the TATMA hit. How comfortable are the clinicians that you talk to or that you've worked with so far in saying, "Yes, they want this product, and it is clearly something that is needed on an urgent basis, and I'll hop back in the queue"? Thank you.

Speaker #2: Okay. Let me dive right in. The patient population you're talking about right now is very, very sick, and they've also had extraordinary expenses paid for, you know, their treatment process up until the TATMA hit.

Speaker #2: How comfortable are the clinicians that you've talked to or that you've worked with so far in saying, "Yes, they want this product and it is clearly something that is needed on an urgent basis and I'll hop back in the queue?" Thank you.

Gregory Demopulos: My take on that is that the physicians are eagerly awaiting the approval of NurSupplement. But let me hand that over to Nadia, who I think can give you more detailed information on the response from physicians. Nadia?

Speaker #4: On On my take on that is that the physicians are eagerly awaiting the approval of Nur-Supplement, but let me hand that over to Nadia who I think can give you more detailed information on the response from physicians Nadia?

Jennifer Williams: Yeah. Yeah, thanks, Greg. Steve, it's really a significant response from physicians about the need for NurSupplement. You can imagine, you just commented on it, that these patients have been through so much just to go on this journey with transplant. And to be sort of nearing getting out of the woods and then having a lethal complication is absolutely not what the physicians nor the patients would want. And so they see this as a much-needed solution, the fact that it would be indicated, the first and only. And in terms of those that have had response already through the expanded access program, they're eager to have this approved and be able to assist these patients.And

Speaker #6: Yep. Yeah, thanks, Greg. Steve, it's really a significant response from physicians about the need for Nur-Supplement. You can imagine, and you just commented on it, that these patients have been through so much just to go on this journey with transplant.

Speaker #6: And to be sort of nearing, getting out of the woods and then having a lethal complication is absolutely not what the physicians or the patients would want.

Speaker #6: And so they see this as a much-needed solution, the fact that it is it would be indicated, the first and only. And in terms of those that have had response already through the expanded access program, they're eager to have this approved and be able to assist these patients and to avoid these kinds of complications.

Speaker 1: to avoid these kinds of complications.

David Borges: Got it. Does that answer the question, Steve? I think, I think if there's any, if there's any bright side to the length of time we've been waiting to get Norsoplamab approved in PATMA, it's been the ability for physicians through the expanded access program and obviously through numerous conference presentations, publications to understand the effects of Norsoplamab, the benefits of Norsoplamab, and frankly, some of the the challenges or risks associated with potential competitors in development.

Speaker #5: Got it.

Speaker #4: That answered the question, Steve? I think if there's any bright side to the length of time we've been waiting to get Nur-Supplement approved in TATMA, it's been the ability for physicians through the expanded access program and obviously through numerous congress presentations, publications, to understand the effects of Nur-Supplement, the benefits of Nur-Supplement, and frankly, some of the challenges or risks associated with potential competitors in development.

Jennifer Williams: Got it. Thanks again for the details.

Speaker #5: Got it. Thanks again for the details.

Gregory Demopulos: One moment for our next question. Our next question comes from Brandon Folkes with AC Wainwright. Your line is open.

Steve Brozak: Hi. My question is in congratulatory favor. Firstly, if you are approved in December, how long would you anticipate before you could launch the product? And then maybe just sort of along those same lines, you know, I think going into the prior you do for, I'm talking a couple of years ago, I know you bought a fair amount of inventory. So I'm just thinking if we should be thinking about the same sort of approach this way around and modeling that into our R&D spend in 4Q. Thank you.

David Borges: Good, good question, Brandon. Thank you. You were breaking up a bit, but I think I caught it. We again are hopeful that we will reach an approval decision before December. But using your assumptions that approval were to occur in December, we would, as you understand, not be launching in December, but we would be launching then in the first quarter. And I think obviously we are geared up and ready to go with respect to supply. We have substantial supply. And that is not going to be a challenge in any way for us. Nadia, do you have any comments on the launch or David on supply?

Catherine Melfi: I'll build on the launch before David comments on the supply. What we have in place is a plan to, upon approval, immediately train our field team that's in place on the Norsoplamab package insert information, and they will be deployed immediately upon certification, followed by the sales reps then that would be onboarded. So we will be driving awareness, education, and demand immediately upon approval. And then we have some other things lined up that would be non-personal in terms of digital tools and other things to supplement that because we view this as really it's two-pronged. We have to continue the education on PATMA while then educating on Norsoplamab while the supply prepares to fill the channel as well. David, let me hand it back to you.

David Borges: Yeah, with respect to supply, we have adequate supply for the first several years from launch. So I think we're in great shape there with respect to our inventory. Brandon?

Steve Brozak: Thank you very much, Greg, and everyone. That answers my questions. And congrats on the progress.

David Borges: Yeah, thank you.

Gregory Demopulos: One moment for our next question. Our next question comes from Olivia Brayer with Cantor. Your line is open.

Olivia Brayer: Hi, good afternoon. Thank you for the question. Greg, can you talk about what the FDA requested that actually led to the three-month pitufa delay? Was it additional data from the historical database or or something else? And then anything in that request that was maybe unexpected? And then I've got one follow-up.

David Borges: Hi, Olivia. Thanks for the question. It was really additional analyses. There were a number of analyses that they were requesting. And frankly, I think it may have been a bit overwhelming the amount of data that we subsequently supplied in response. And so I, I that that is my view of that. Kathy, do you want to to elaborate?

Catherine Melfi: Yeah, I, I, again, as Greg said, they requested additional analyses. Apparently felt that they could not review it in time to make the original pitufa date. And as you know, when you get a major amendment, the standard is to act three months onto the pitufa date. We're continuing to work with FDA, and what we're hoping, as Greg said before, we can bring it in even earlier than the December 26th date.

David Borges: The relationship, Olivia, has been really quite collaborative. I know that there are a number of issues that are at least finding their way into the press around FDA and and recent responsiveness. Frankly, we have not encountered any of that with this division. The interactions have been responsive and and very collaborative. So to date, that's that's how we have found this process.

Olivia Brayer: Yeah, good. That's great. I'm happy to hear that. And hopefully, that continues going forward. And then can you tell us anything more about the potential partnership that you're pursuing and just maybe, you know, what kind of partnership and which program in particular that you're looking to partner out?

David Borges: Yes. All I can say on that at this point is that there's substantial interest really across our programs. And we've outlined the parameters of one such partnership. And as you might imagine, we're required to do so as part of our equity financing to make sure that all all material non-public information was cleansed. So I I think we've said really all that we can say or or really will say on that topic at this point. but I I think our our referencing it, by definition means that it is material, from our position.

Olivia Brayer: Okay. Understood. Thank you very much.

David Borges: Thanks, Olivia. Thank you.

Gregory Demopulos: And I'm not showing any further questions at this time. I'd like to turn the call back over to Dr. Demopulos for any further remarks.

David Borges: All right. Thank you, operator. thank you, everyone, for joining this afternoon. we apologize for that initial difficulty with the technical component. I appreciate the help, though, that, our provider did did put forth to fix the problem quickly. So thank you. But as as you can see, Omeros has a good number of value-driving milestones in process. And, we look forward to sharing more information with you throughout the remainder of 2025. All of us at Omeros appreciate your continued support and look forward to sharing further updates with you. have a good evening.

Gregory Demopulos: Thank you, ladies and gentlemen. This does conclude today's presentation. We do thank you for your participation, and you may now disconnect and have a wonderful day.