Omeros Company (NASDAQ:OMER) This fall 2023 Earnings Convention Name April 1, 2024 4:30 PM ET
Firm Individuals
Peter Cancelmo – Investor RelationsGregory Demopulos – Chairman and Chief Government OfficerMichael Jacobsen – Chief Accounting OfficerSteven Whitaker – Vice President, Scientific DevelopmentCatherine Melfi – Chief Regulatory OfficerNadia Dac – Chief Industrial OfficerAndreas Grauer – Chief Medical Officer
Convention Name Individuals
Olivia Brayer – Cantor FitzgeraldStephen Brozak – WBB SecuritiesSerge Belanger – Needham
Operator
Good afternoon and welcome to right now’s convention name from Omeros Company. At the moment, all individuals are in a listen-only mode. After the corporate’s remarks, we are going to conduct a question-and-answer session. Please be suggested that right now’s name is being recorded on the firm’s request and a replay might be out there on the corporate’s web site for one week from right now.
I am going to flip the decision over to Peter Cancelmo, Basic Counsel of Omeros. You’ll be able to start.
Peter Cancelmo
Good afternoon and thanks for becoming a member of the decision right now. I might wish to remind you that a few of the statements that might be made on the decision right now might be forward-looking. These statements are based mostly on administration’s beliefs and expectations as of right now solely and are topic to vary.
All forward-looking statements contain dangers and uncertainties that would trigger the corporate’s precise outcomes to vary materially. Please seek advice from the Threat Issue part of the corporate’s annual report on Kind 10-Ok, which was filed with the SEC right now for a dialogue of those dangers and uncertainties.
Now I wish to flip the decision over to Dr. Greg Demopulos, Omeros’ Chairman and CEO.
Gregory Demopulos
All proper. Thanks, Peter, and good afternoon, everybody. I am joined on right now’s name by our Chief Accounting Officer, Mike Jacobson; and our Chief Industrial Officer; Nadia Dac; our Chief Medical Officer, Andreas Grauer; our Chief Regulatory Officer, Cathy Melfi; and our Scientific Vice President, Steve Whitaker.
Our dialogue right now will embody a quick overview of our monetary outcomes for the fourth quarter ended December 31, 2023 in addition to a company replace. Mike will then present a abstract of monetary outcomes for the full 12 months and additional particulars on the fourth quarter of 2023.
The question-and-answer interval will observe Mike’s remarks. For these of you that continuously be a part of our name, you can find that right now’s name might be longer than normal. And that is as a result of there are lots of thrilling issues taking place on the firm, and we wish to take the time to share them with you.
In our third quarter earnings name, I recognized 4 company priorities that symbolize vital drivers of close to to midterm worth in our inventory value. These 4 priorities are. One, extending our money runway into 2026 with out diluting shareholders. Two, acquiring FDA approval of narsoplimab, our MASP-2 inhibitor in hematopoietic stem cell transplant-associated thrombotic microangiopathy or TA-TMA and efficiently launching the drug to market. Three, driving our MASP-2 inhibitor, OMS906 right into a Section III medical program as quickly as potential, each in paroxysmal nocturnal hemoglobinuria, or PNH, and in C3 glomerulopathy and 4, transferring OMS1029, our long-acting MASP-2 inhibitor within the Section II medical trial in a big worth indication. We’ll take these one after the other.
First, extending money runway with out dilution. This was completed in February via an extra royalty take care of DRI Healthcare, extending our runway into 2026. That transaction introduced in $116 million of nondilutive capital with the chance to earn an extra whole of $55 million in two extra sales-related milestone funds.
All of that is on high of $125 million upfront fee plus retained receivables from Rayner Surgical to whom we offered OMIDRIA in 2021. Two, one other $125 million in late 2022 after we offered a portion of our future OMIDRIA royalty stream to DRI Healthcare care and three, $200 million extra obtained early in 2023 in a milestone fee from Rayner tied to attaining long-term reimbursement for OMIDRIA.
Along with this string of funds, Omeros retains the 15% royalty on ex-US OMIDRIA gross sales after which starting on January 1 of 2032, all OMIDRIA royalties from gross sales anyplace on the planet will accrue to Omeros. Since its sale to Rayner in December of 2021, a bit of over two years in the past, OMIDRIA has offered Omeros with almost $700 million of nondilutive financing.
This influx of nondilutive capital has helped to safe Omeros’ sturdy monetary place. Now let’s take a look at our monetary outcomes for each the fourth quarter and the 12 months. Our web loss for the fourth quarter and a part of a mirrored image of the revaluation of our OMIDRIA contract royalty asset was $9.1 million or $0.15 per share in comparison with a web lack of $37.8 million or $0.60 per share within the third quarter of 2023 and a web earnings of $128.7 million or $2.05 per share for the fourth quarter of 2022.
The outcomes of the prior 12 months fourth quarter had been pushed by the $200 million OMIDRIA milestone earned by securing for the drug long-term separate fee. Based mostly solely on persevering with operations, our web loss for the fourth quarter of 2023 was $39.3 million or $0.63 per share in comparison with a web lack of $51.7 million or $0.82 per share within the third quarter and a web lack of $46 million or $0.73 per share for the fourth quarter of 2022.
These symbolize enhancements of $12.4 million and $6.7 million, respectively. For the complete 12 months 2023, our web loss was $117.8 million or $1.88 per share in comparison with web earnings of $47.4 million or $0.76 per share in 2022. Right here, once more, the first distinction between the 2 years is the $200 million OMIDRIA milestone earned in 2022 and obtained in February 2023. Our 2023 full 12 months web loss from persevering with operations was $175 million or $2.79 per share in comparison with a lack of $182 million or $2.90 per share for 2022.
So in abstract, money offered for operations, which means optimistic money move into the corporate, for the 12 months ended December 31, 2023, was $74.7 million, which incorporates receipt of the $200 million milestone in February 2023. Our change in money and investments for the fourth quarter of 2023 was considerably affected by three occasions.
First, $95 million used to repay our excellent 2023 convertible notes at maturity. Second, $4.9 million used to repurchase $9.1 million principal quantity of our 2026 convertible notes at 54% of par worth. And third, $4.7 million used to repurchase 1.8 million shares of our widespread inventory.
Our fourth quarter money utilized in operations, which not has included these three occasions was $34.8 million. As of December 31, 2023, we had $172 million of money and investments, with the extra $116 million royalty buy fee from DRI in February of this 12 months, our whole anticipated money and investments at March 31, 2024 is roughly $230 million. This ought to be adequate to fund operations and debt service into 2026.
Now we have not finished a dilutive financing transaction at Omeros since August of 2020 and in line with this effort to guard our shareholders, the newest DRI deal additional extends our runway with out dilution.
In reality, since saying a share repurchase program in November 2023, we have lowered the variety of shares excellent via the repurchase of roughly 5 million shares representing an 8% discount in our excellent share rely. Within the fourth quarter, as beforehand famous, we additionally had been in a position to repurchase $9.1 million of 2026 convertible notes at 54% of par.
Let’s now flip to our subsequent company precedence, acquiring FDA approval of our MASP-2 inhibitor, narsoplimab in TA-TMA. As beforehand mentioned, we have labored with FDA since receiving a whole response letter on our biologics license utility, or BLA, for narsoplimab in TA-TMA.
The late 2022 resolution from FDA’s workplace of latest medication adopted our formal dispute decision and that recognized potential paths for resubmission of the BLA. According to that call and with subsequent interactions with FDA’s overview division, we developed and submitted for FDA’s overview within the fourth quarter of final 12 months, a proper evaluation plan evaluating survival knowledge from our pivotal TMA trial to survival knowledge from an exterior management.
The FDA responded with inquiries to which we offered detailed solutions, and the dialogue continues with FDA concerning beneficial parts for a profitable resubmission of our BLA. Every spherical of interactions with FDA has ruled by formal assembly guidelines, together with these directed to overview period. So at this level, I haven’t got a agency date for our BLA resubmission or the associated resolution date for approval. Once we do, we are going to give you an replace. Whereas ready, we have accomplished a lot of the sections of our BLA.
We’re additionally making good progress on our advertising authorization utility for submission to the European Medicines Company for narsoplimab in TA-TMA. Because the regulatory course of for narsoplimab in TA-TMA advances in each the US and in Europe, sufferers with TA-TMA and their physicians proceed to confront an unpredictable and sometimes deadly situation with out an approval or many consultants consider with out even a really passable off-label therapy possibility.
We proceed to obtain an growing quantity of request for narsoplimab beneath our expanded entry or compassionate use program from physicians treating each grownup and pediatric TA-TMA sufferers. We stay dedicated to making an attempt to supplying narsoplimab all around the world to assist these sufferers.
Typically these are youngsters who’ve endured the assault of most cancers, adopted by the hope of a treatment via a stem cell transplant solely to have that care taken from them and their households by TMA. We have handled over 130 TA-TMA sufferers in narsoplimab expanded entry program.
Whole of 53 of those adults and pediatric sufferers had beforehand failed or stopped therapy regimens with a number of different brokers, particularly eculizumab, ravulizumab, defibrotide and/or pegcetacoplan. So most of them by the point narsoplimab was requested can be anticipated to have a poor end result, but after receiving narsoplimab therapy, about half of them these sufferers who’ve been beforehand handled achieved one 12 months survival from date of TMA and utilizing the opposite widespread metric from date of transplant about two-third achieved one-year survival.
Survival charges are even increased in each grownup and pediatric expanded entry sufferers whose preliminary and solely therapy was narsoplimab. So it actually seems that narsoplimab is saving the lives of each youngsters and adults.
A bunch of worldwide transplant consultants have begun work getting ready a manuscript for peer-reviewed publication directed to the advantages of narsoplimab within the over 130 grownup and pediatric TMA sufferers globally who had been in a position to entry narsoplimab beneath compassionate use. Outcomes from our expanded entry program have been reported in a rising physique of publications in peer-reviewed journals and at worldwide congresses.
In a current journal article from Emory College revealed in transplantation and mobile remedy, two infants, a 10-year-old and two adolescents with extreme and worsening TA-TMA all with multi-organ involvement have failed therapy with eculizumab. Survival in these sufferers is reported to be lower than 20%.
These 5 youngsters who had failed eculizumab had been then handled with narsoplimab, 60% responded. Investigators of Memorial Sloan Kettering Most cancers Middle revealed a report in bone marrow transplantation describing for the primary time narsoplimab’s potential to realize a whole response, whereas permitting the physicians to take care of the usage of calcineurin inhibitors and mTOR inhibitors in a high-risk TA-TMA affected person.
Calcineurin and mTOR inhibitors are identified to potentiate TA-TMA are identified to trigger or additional TA-TMA. And their withdrawal has traditionally been thought-about step one in managing TA-TMA. The draw back of withdrawing these brokers although is that they’re utilized in stem cell transplant to forestall life-threatening graft versus host illness or GvHD. So their withdrawal will increase the danger of mortality.
We’re conscious of different transplanters who now equally use narsoplimab with good outcomes to deal with TA-TMA whereas sustaining the calcineurin and mTOR inhibitors to forestall doubtlessly deadly GvHD. The power of narsoplimab to permit physicians to deal with TA-TMA with out withdrawing these GvHD stopping brokers would symbolize an extra vital advance of the drug and the administration of TA-TMA.
In February, a poster offered on the 2024 tandem assembly of the American Society for Transplantation and Mobile Remedy and the Middle for Worldwide Blood and Marrow Transplant Analysis reported that six of 9 grownup TA-TMA sufferers demonstrated a whole and sturdy response to narsoplimab therapy.
The opposite three sufferers achieved a partial response. Median period of therapy throughout the sufferers was six weeks. The report was authored by an exterior group of US investigators from Vanderbilt, Sarah Cannon Analysis Institute, The College of Arkansas and Indiana Blood and Marrow Transplantation.
Most lately, an summary revealed within the American Journal of Kidney Ailments described a 24-year previous man who underwent allogeneic stem cell transplantation for aplastic anemia. He subsequently developed high-risk TA-TMA. Eculizumab was initiated on hospital Day two.
On Day 18, the affected person developed the extreme lung dysfunction, diffuse alveolar hemorrhage and on Day 30, hemodialysis was began for septic acute tubular necrosis, a extreme kidney dysfunction. Narsoplimab was initiated 31 days afterward Day 61. Regardless of the late begin of narsoplimab therapy, this affected person with multi-organ illness who was refractory to eculizumab, so an estimated mortality of 70% to 80% responded to narsoplimab.
So the proof continues to mount and I feel the conclusion that we’re actually drawing is that narsoplimab is displaying good leads to TA-TMA sufferers. Turning now to the third of our key priorities. We proceed to advance OMS906, our MAP-3 inhibitor concentrating on the choice pathway of complement via a number of ongoing Section II research in two uncommon illness indications, paroxysmal nocturnal hemoglobinuria or PNH life-threatening ailments of the blood and complement to glomerulopathy or C3G, a debilitating and doubtlessly life-threatening kidney illness.
In distinction to our narsoplimab program for TA-TMA, which, by its nature, requires the event of novel medical endpoints for a drug with a novel mechanism in a illness for which no drug has been authorised. Our OMS906 program has some great benefits of following different various pathway inhibitors into growth and affording sufferers and physicians significant potential advantages not shared by these different therapies. That is vital for a number of causes.
First, the mechanism of other pathway inhibition has already been clinically validated by different brokers for the therapy of numerous ailments. Thereby already demonstrating the potential therapeutic worth of OMS906. Second, in designing our Section III medical trials, we can observe the medical street map established via the event of different various pathway concentrating on brokers.
And third, we’re designing our medical trials to reveal the potential benefits over different complement inhibitors in the marketplace or in growth. Past PNH and C3G through which we have now ongoing medical applications, various pathway inhibition has additionally been clinically validated by different various pathway inhibitors in geographic atrophy and in IgA nephropathy. We beforehand have detailed what we see as the most important differentiators between MAP-3 and OMS906 versus different various pathway targets and therapeutics both authorised or in growth.
Briefly, primary, not like C3 and C5 inhibitors, MASP-3 inhibitors preserve the physique’s an infection preventing potential. Quantity two, not like Issue B, C3 and C5 MASP-3 when examined has been proven to not be an acute part reactants and has a really low native circulating ranges relative to different various pathway targets.
Consequently, OMS906 ought to preserve extra constant inhibition of MAP-3 than medication concentrating on issue B, C3 or C5 offering higher safety towards doubtlessly life-threatening breakthrough of a affected person’s underlying illness.
And quantity three, OMS906 ought to ship higher affected person comfort, and consequently, compliance than the opponents by permitting as much as as soon as quarterly intravenous and subcutaneous administration. In response to recommendation from key opinion leaders, we’re exploring two therapy regimens each 8 weeks and each 12 weeks, offering sufferers and physicians a set of choices to suit their preferences and native requirements and benefit provided by no different various pathway inhibitors in the marketplace or in growth.
Simply right now, danicopan, a Issue D inhibitor was authorised by FDA for the therapy of PNH together with the C5 inhibitor. Scientific trial, the addition of the danicopan was proven to considerably enhance efficacy over C5 inhibition alone.
OMS906 inhibits MASP-3 and MASP-3 is the enzyme that prompts Issue D danicopan goal. This could take away any query of the possible efficacy of OMS906. Danicopan is an oral medicine that must be taken thrice each day within the required mixture with a C5 inhibitor meaning a thrice day by day tablet on high of a frequent or much less frequent IV or subcutaneous infusion.
This dosing routine represents a considerable affected person burden and a possible vital threat of noncompliance and breakthrough of extravascular hemolysis. As compared, OMS906 is a monotherapy anticipated to have each 8 weeks or each 12-week dosing. Notably, Jefferies Analysis Group issued a report simply right now estimating danicopan worldwide annual peak gross sales at $750 million.
This, once more, on high of the price of the required companion C5 inhibitors like eculizumab and ravulizumab. This projection and the truth that OMS906 is being developed as single-drug remedy with extra handy dosing ought to additional validate the worth of our OMS906 asset.
Our medical program evaluating OMS906 for the therapy of PNH is continuing nicely. We convened an advisory board final week comprised of worldwide consultants and PNH to debate particulars of our PNH program, together with our Section III protocol design.
The advisers’ curiosity in and enthusiasm for OMS906 are uniformly excessive, and we stay up for their ongoing steering as we transfer into and thru our Section III program. At the moment, we have now two ongoing Section II research, each of that are absolutely enrolled and each of which now have reported optimistic interim evaluation knowledge.
Knowledge from these research in PNH sufferers and from our ongoing increased dose PK/PD research in wholesome topics ought to present the knowledge essential to find out our remaining Section III dosing. Our latest knowledge come from our Section II medical trial evaluating OMS906 in PNH sufferers who’ve had an unsatisfactory response to the C5 inhibitor, ravulizumab.
The research has a switchover design and enrolled sufferers receiving ravulizumab added OMS906 to offer mixture remedy with ravulizumab for twenty-four weeks after which offered OMS906 monotherapy in sufferers who demonstrated a hemoglobin response with mixture remedy.
The trial is absolutely enrolled with a complete of 13 sufferers. Knowledge from the prespecified interim evaluation of the trial’s mixture remedy portion present speedy response to OMS906, with statistically vital and clinically significant enhancements in each imply hemoglobin ranges and absolute reticulocyte rely by Week 4 of mixture remedy.
Response was sustained for Week 24, which is the most recent evaluation previous to the interim evaluation cutoff. These interim evaluation knowledge reveal that in sufferers experiencing substantial extravascular hemolysis whereas on ravulizumab monotherapy, the choice pathway inhibitor, OMS906 stop extravascular hemolysis as anticipated. The addition of OMS906 was nicely tolerated with an excellent security profile. Full particulars from the interim evaluation have been submitted for presentation on the Congress of the European Hematology Affiliation, or EHA, which can happen in June.
As with virtually all worldwide congresses, particulars of the submissions are embargoed by EHA till accepted displays are revealed on-line, and that can happen in mid-Might. Interim evaluation knowledge from the monotherapy portion of our switchover trial are anticipated to be out there later this 12 months.
In December, new and up to date interim evaluation knowledge from our different Section II medical trial evaluating OMS906, this one in naive PNH sufferers or those that haven’t beforehand been handled with a complement inhibitor had been featured as an oral presentation on the Annual Congress of the American Society of Hematology, or ASH.
Clinically significant and helpful results of OMS906 on hemoglobin, LDH, and purple blood cell clone measurement in PNH sufferers had been reported. On this newest evaluation, all 11 enrolled sufferers achieved will increase in hemoglobin of a minimum of 2 grams per deciliter.
Notably, all 9 sufferers who didn’t have myelodysplastic syndrome, a situation inflicting bone marrow failure. All 9 of these achieved an absolute hemoglobin higher than 12 grams per deciliter, a degree cited as regular by others working within the discipline.
Constant advantages had been additionally noticed in imply modifications from baseline in hemoglobin, LDH, and absolute reticulocyte rely. All of those sufferers had been handled with OMS906 at a dose of 5 milligrams per kilogram subcutaneously as soon as each 4 weeks.
After observing efficacy on this research, we amended the protocol to concentrate on figuring out the OMS906 doses that present safety from breakthrough hemolysis for each 8-week and 12-week period.
To help the longer term submission of a BLA for OMS906 in PNH, we started enrolling an extension research to gather long-term efficacy and security knowledge in PNH sufferers. Sufferers roll from both the Section II switchover trial, or from the Section II naive affected person trial instantly into the extension research and not using a break in OMS906 therapy.
Dosing within the extension research is already underway. In February, we met with FDA to debate our growth program for OMS906 in PNH. We have offered medical and nonclinical knowledge and requested enter on expectations for Section III research and for BLA submission.
FDA confirmed that the scope of our nonclinical program is adequate to help Section III research and offered enter on dosing and design of the proposed Section III research to help a BLA in PNH. We’ll meet once more with FDA later this 12 months to debate additional Section III trial design particulars and the strategy to our BLA submission.
As a part of our European technique for OMS906 and PNH, we have now requested a gathering with European regulators at which we are going to current out there medical and nonclinical knowledge and focus on Section III growth.
Shifting on to our Section II medical trial evaluating OMS906 in C3G, websites at the moment are open in a number of international locations and sufferers are being screened. As beforehand mentioned, we selected to amend the C3G protocol, altering the dose based mostly on data realized in our PNH program.
This selection resulted in a delay in research initiation, however ought to present a greater estimate of therapy impact for the design of the Section III program. We anticipate Section III initiation within the first a part of 2025. Notably, the relevance of the choice pathway in C3G was validated by Novartis in a press launch reporting a optimistic Section III research with iptacopan, Novartis’ various pathway inhibitor concentrating on Issue B.
We count on to start enrollment in our Section II C3G trial this month. So we have spent an excellent period of time in our replace right now on OMS906 and all the continuing Section II and upcoming Section III trials. The aim was to give you a greater understanding of the substantial worth that continues to accrue on this program. Worth that we consider has been under-recognized by the funding neighborhood.
Briefly, the info from our ongoing Section II PNH research have been persistently optimistic, various pathway inhibition has been clinically validated throughout numerous ailments. And we’re continuing via a longtime medical growth pathway with what we consider is a well-differentiated drug that presents a number of potential benefits over various pathway inhibitors in the marketplace or in growth.
For these causes, we consider that OMS906 may turn into the first-line normal of take care of the therapy of PNH and a bunch of different various pathway ailments. Now I am going to flip again to our household of brokers concentrating on MASP-2 and the lectin pathway to debate briefly our findings within the Section III IgA nephropathy trial and the final of the important thing priorities recognized on the outset of right now’s name, OMS1029. As introduced final October, we discontinued our narsoplimab Section III ARTEMIS-IGAN trial in IgA nephropathy following a disappointing end result from a prespecified interim evaluation.
Throughout our final earnings name, we mentioned the trial’s surprising substantial placebo impact. High line outcomes present that narsoplimab didn’t attain statistical significance over placebo on the first endpoint of proteinuria discount at 36 weeks in IgA nephropathy sufferers with baseline proteinuria higher than 2 grams per day.
Along with exterior consultants, we additional reviewed the trial knowledge. PK/PD analyses point out that many sufferers within the Section III trial didn’t obtain enough and sustained plasma concentrations of narsoplimab and consequently didn’t obtain significant and sustained ranges of lectin pathway inhibition.
This partially seems to be as a result of episodic dosing within the trial. As soon as quarterly dosing with our MASP-2 inhibitor or OMS1029 ought to we resolve to guage it in IgA nephropathy or every other continual renal illness can be anticipated to keep away from this downside. Work continues to determine a number of biomarkers that we’d count on to allow enrichment of any renal research inhabitants with sufferers whose illness particularly is pushed by lectin pathway hyperactivation.
In parallel and in line with our fourth company precedence, we’re evaluating for OMS1029, a collection of continual giant worth indications through which selective pathway has been implicated within the pathogenesis of the illness.
OMS1029 has efficiently accomplished a Section I single ascending dose research supporting as soon as quarterly dosing administered both subcutaneously or intravenously. The second half of that Section I program on a number of ascending dose research of OMS1029 lately accomplished dosing and is anticipated to learn out knowledge later this quarter.
One of many giant market indications for OMS1029 that we’re contemplating is neovascular age-related macular degeneration, also called moist AMD. Now we have beforehand reported that preclinical research demonstrated efficacy and a well-established mirroring mannequin.
To additional derisk a medical program, we’re transferring shortly to guage MASP-2 inhibition in a primate mannequin of moist AMD. Notably, all authorised remedies for moist AMD akin to Lucentis and Eylea require intravitreal injections, which means injections into the again chamber of the attention. These injections are required as continuously as each 4 weeks. Since MASP-2 is barely produced within the liver, systemic administration may present therapeutic profit with out the necessity or intravitreal injections.
In different phrases, an intravenous infusion — or subcutaneous injection might enable sufferers to each preserve web site and keep away from injections of their eyes, a possible recreation changer for each sufferers and their physicians. We’re concentrating on subsequent quarter to pick the Section II indications or OMS1029. So of our 4 company priorities, extending money runway nondilutively into 2026 narsoplimab approval, accelerating OMS906 within the Section III trials and initiating an OMS1029 Section II program, one has already been achieved and the others we’re nicely on our approach to attaining this 12 months.
Improvement can also be advancing throughout a collection of different applications that we consider via comparatively modest funding to meaningfully add shareholder worth. For narsoplimab in COVID-19 in acute respiratory misery syndrome or ARDS, quite a few analysis teams, together with ours have revealed a rising quantity of journal articles demonstrating the function of complement and/or the lectin pathway in ARDS. One other manuscript is being finalized for submission. This one displaying the therapeutic advantages of MASP-2 inhibition in an animal mannequin of extreme Haemophilus influenzae an infection.
Narsoplimab is especially nicely suited to ailments like ARDS, acute indications requiring hospitalization. There’s additionally mounting proof that MASP-2 and the lectin pathway may nicely be vital drivers of lengthy COVID. The challenges in assessing a therapeutic in lengthy COVID are the shortage of standardized diagnostic standards and medical endpoints, and we’re making headway in figuring out approaches to deal with these.
In parallel, we have developed an assay platform that may determine and discriminate between delicate COVID-19 sufferers and people who have reasonable or extreme COVID-19-related ARDS requiring hospitalization. The assay additionally has the potential to be used in lengthy COVID in addition to different disease-related ARDs.
The assays core measurement is the MASP-2 C1 inhibitor advanced, a proprietary, extremely delicate and particular marker of lectin pathway hyperactivation. There is a acknowledged want for such an assay and we’re evaluating our choices for finishing its growth and commercialization.
Turning to our orally administered MASP-2 inhibitor program. We proceed to advance testing to allow the submitting of an investigational new drug utility. The entire franchise of intravenous narsoplimab, our long-acting subcutaneous inhibitor OMS1029 and our oral MASP-2 blocker, we count on will allow Omeros to manage first-line remedy for each acute and continual lectin pathway-related ailments.
Let’s now transfer on to OMS527, our PDE7 inhibitor program concentrating on addictions and compulsions in addition to motion issues. With predictive and well-established animal fashions displaying efficacy throughout opioids, cocaine, nicotine, alcohol and binge consuming, the Nationwide Institute on Drug Abuse, or NIDA, requested and is funding our growth of OMS527 as the primary therapy for cocaine use dysfunction.
Toxicity knowledge in primates receiving each cocaine and OMS527, an ordinary toxicology research to help human research of therapy for cocaine dependancy are anticipated late this 12 months and assuming success of randomized, double-blind inpatient medical trial is slated to start subsequent 12 months.
For OMS527 and levodopa-induced dyskinesias or LID usually crippling involuntary actions that finally happen in almost all the tens of millions of Parkinson’s sufferers handled with L-DOPA, primate research had been carried out at Emory College and with the investigators additional growth has been mapped out.
To wrap up the company overview, I am going to contact briefly on our 5 proprietary immuno-oncology platforms, adaptive T-cell remedy, CAR-T, signaling pushed immunomodulators, antigen-driven immunomodulators that perform each as therapeutics and vaccines and Oncotoxins. I described these 5 platforms in our August and November 2023 earnings calls, so would refer you there for extra detailed data.
So far, in vitro, ex-vivo and animal research utilizing human mobile elements have been optimistic with sturdy response charges. The information point out numerous potential benefits of our immuno-oncology franchise. And people, once more, had been elucidated in our August and November earnings name.
So we proceed to verify our outcomes and to generate new knowledge throughout our I-O franchise. Assuming that our progress continues to advance on tempo, we count on to have the ability to share a lot of those knowledge within the second half of this 12 months.
I am going to now flip the decision over to Mike Jacobson, our Chief Accounting Officer, to undergo a extra detailed dialogue of our monetary outcomes. Mike?
Michael Jacobsen
Thanks, Greg. Our web loss for the fourth quarter was $9.1 million or $0.15 per share in comparison with a web lack of $37.8 million or $0.60 per share within the third quarter of this 12 months. If we take a look at simply the persevering with operations, our web loss for the fourth quarter was $39.3 million or $0.63 per share in comparison with a web lack of $51.7 million or $0.82 per share within the third quarter. That is an enchancment of $12.4 million.
The development was primarily as a result of an $8.4 million discount in working prices and the $4.1 million acquire on the early retirement of a portion of our 2026 notes. As of December thirty first, we had $172 million of money and investments available.
That is after extinguishing the $95 million excellent on our 2023 convertible notes on their November due date, utilizing $4.9 million to retire $9.1 million of our excellent 2026 convertible notes and $4.6 million to repurchase 1.8 million shares or our excellent widespread inventory.
Our money used for operations within the fourth quarter, which doesn’t embody these funds, was $34.8 million. With the extra $116 million fee we obtained from DRI in February, our whole money and investments at March thirty first, 2024, are estimated to be roughly $230 million. That is after repurchasing an extra 3.2 million shares of our excellent widespread inventory for $11.9 million within the first quarter of 2024. And as Greg mentioned, ought to be adequate to fund operations and debt service into 2026.
Prices and bills from persevering with operations for the fourth quarter was $39.3 million, which was a lower of $12.4 million from the third quarter. The lower was primarily as a result of timing of worker compensation prices, the fee of a growth milestone beneath a know-how license within the third quarter and the $4.1 million acquire on the early retirement of a portion of our 2026 notes. Curiosity expense for the fourth quarter was $7.1 million in comparison with $7.9 million within the third quarter.
The lower was primarily as a result of retiring of the $95 million excellent on the 2023 convertible notes in November at their maturity date. Curiosity and different earnings for the fourth quarter was $3.4 million in comparison with $4.4 million within the third quarter of this 12 months. The lower was pushed by decrease money balances after retiring the $95 million of the ’23 convertible notes.
Throughout the fourth quarter, we repurchased $9.1 million of our 2026 convertible notes on the open marketplace for $4.9 million. This represents 54% of the par worth of the notes. We acknowledged the $4.1 million financial savings as a acquire on early extinguishment of debt in our assertion of operations.
Revenue from discontinued operations within the fourth quarter of this 12 months was $30.2 million and consists of two main elements. $26.2 million of remeasurement changes to OMIDRIA contract royalty asset and $3.8 million of curiosity earned on the OMIDRIA contract royalty asset.
As I’ve talked about beforehand, royalties earned are recorded as a discount of the OMIDRIA contract royalty asset on our stability sheet. OMIDRIA royalties for the fourth quarter had been $10.7 million on OMIDRIA web gross sales of $35.7 million. It is a $2.4 million enhance in web gross sales over Q3.
As Greg talked about, in February of this 12 months, we entered into an amended settlement with DRI, the place they acquired the fitting to obtain all remaining US OMIDRIA royalties payable by Rayner via December thirty first, 2031. After December thirty first, 2031, all US royalty funds will accrue to Omeros.
The US royalty price is usually 30% of web gross sales and extends during the related patent phrases, which we count on to be a minimum of via 2035. We’re additionally entitled now and going ahead to any non-US royalties paid, that are usually on the price of 15% of web gross sales. Within the first quarter of 2024, we are going to report the $116 million we obtained from DRI as incremental OMIDRIA royalty obligation on the stability sheet in line with the accounting for the preliminary transaction with DRI.
Throughout the fourth quarter, we repurchased 1.8 million shares of our widespread inventory for $4.7 million beneath a inventory repurchase program. The typical value we paid per share repurchase was $2.54.
Now let’s take a look at our anticipated first quarter outcomes. We count on general working prices from persevering with operations within the first quarter to be barely decrease than from the fourth quarter of 2023, pushed by decrease IGAN trial prices as we full the wind down of medical operations on that program.
Curiosity earnings ought to be almost $3 million after factoring within the $116 million we obtained from DRI. Curiosity expense ought to be roughly $8 million, making an allowance for the mid-November retirement of the 2023 convertible notes and the $116 million we obtained in February from DRI, which for GAAP accounting is taken into account debt.
Revenue from discontinued operations ought to be within the $7 million to $8 million vary. Taking all of this into consideration, we count on our first quarter web loss to be within the $34 million to $37 million vary or $0.58 to $0.63 per share. Moreover, we count on our money and funding stability at March thirty first to be roughly $230 million, which we count on will fund our operations and debt service into 2026.
With that, I am going to flip the decision again over to Greg.
Gregory Demopulos
Thanks, Mike. Let’s open the decision to questions. Operator?
Query-and-Reply Session
Operator
Thanks. [Operator Instructions] And our first query comes from Olivia Brayer from Cantor Fitzgerald. Your line is now open.
Olivia Brayer
Hey, good afternoon, guys. Thanks for the questions. Now that we have seen interim knowledge in-house from the 906 swap research, what are you trying to see from the monotherapy portion of the trial, each when it comes to efficacy measures, but in addition numerous sufferers and size of time on therapy? After which I’ve a fast follow-up.
Gregory Demopulos
Certain. And also you’re speaking in regards to the Section III program?
Olivia Brayer
No. The Section II 906 swap research in PNH, proper. Do not you guys have the, what’s it, 48 to 52 week monotherapy swap portion of the trial that is developing.
Gregory Demopulos
You are speaking in regards to the switchover trial.
Olivia Brayer
Sure, precisely.
Gregory Demopulos
Okay. Nice. Thanks, Olivia. Let me flip that over to Steve?
Steven Whitaker
Certain, Greg. That trial is our PNH-001 research. And also you’re appropriate that it’s a switchover trial. The sufferers obtain adjunctive ravulizumab for six months after which the responders transfer on to monotherapy. We’re hemoglobin, we’re LDA, absolute reticulocyte counts, clone sizes, your normal efficacy measures in addition to security in that research. We’ll have 13 sufferers, if I keep in mind who’re enrolled in that trial, and we anticipate to see knowledge from the monotherapy elements or the monotherapy a part of that trial in late ’24, sufferers are already advancing from the adjunctive therapy to the monotherapy therapy.
Olivia Brayer
Okay. Understood. After which on the narsoplimab BLA, what innings are you in, when it comes to reaching an settlement with FDA? I assume what I am making an attempt to determine, Greg, is how a lot engagement you have had with them to this point this 12 months? And the way shut you might be to having a extra concrete replace from them?
Gregory Demopulos
Sure. We have had, and I’d characterize it as substantial interplay with them. And with respect to when will we count on to have the ability to say extra, as I’ve mentioned, within the ready feedback, Olivia, first, we actually do not focus on forwards and backwards with FDA. But additionally simply given time traces for conferences and the principles related to these conferences and Kind A versus Kind B. I feel it’ll be troublesome and in reality we’re not making an attempt to have the ability to offer you proper now a time line for after we can be resubmitting the BLA. Clearly, we predict we have finished the work required beneath the OND ruling following our apeal and the enchantment and the entire response letter. So I feel we consider we’re in fine condition. However I feel with respect to timing, I feel that is one thing that we’re simply going to have to carry on discussing proper now. Cathy, do you wish to add something particular to that?
Catherine Melfi
No, I feel you lined it, Greg, however the interactions are ongoing, however we be ok with the fee.
Olivia Brayer
Okay, that is useful. Thanks, guys.
Operator
Thanks. [Operator Instructions] And our subsequent query comes from Steve Brozak from WBB Securities. Your line is now open.
Stephen Brozak
Hey, good afternoon and thanks for taking the questions. With, as you talked about earlier, Danicopan approval, how does this have an effect on 906. And the way does it change it, if in any respect? Are you able to be as detailed as potential, please?
Gregory Demopulos
Sorry, how does it change what, Steve?
Stephen Brozak
How does it change the way you take a look at 906 going ahead if in any respect?
Gregory Demopulos
Sure. Thanks for the query. I feel that is going to be a bit repetitive of what I’ve mentioned within the feedback. However I feel the distillate of the Danicopan approval actually is all optimistic as we see it for OMS906 primary. It actually validates inhibition of MASP-3 in its place pathway inhibitor and as an efficient various pathway inhibitor. Keep in mind that MASP-3 is one step proximal within the pathway to Issue D. So it is MASP-3 that truly converts professional Issue D to Issue D. The benefit of inhibiting MASP-3 over Issue D is that Issue D turns over very, in a short time. 50% of Issue D turns over in circulation each hour and that makes it an clearly tougher goal to drive. And the results of that’s possible in a thrice day by day oral dosing of Danicopan. So I feel after we take a look at it, we see great. I imply, what they’ve finished is validate the choice pathway, validate the proximal a part of the choice pathway, of which we’re probably the most proximal. After which if you take a look at their should be along side C5 inhibitors. And we’re coming with a monotherapy that addresses each intravascular and extravascular hemolysis can do this with each 8 week or each 12-week dosing. If you begin to have a look at these benefits, we predict all of this actually inures to the advantage of OMS906 and positively underscores the worth of this system. However let me cease and I will look each to Andreas and Steve and to Nadia as nicely and see in the event that they produce other ideas or different feedback.
Nadia Dac
Sure. Thanks, Greg. Danicopan addresses a spot within the AZ and the Alexion portfolio. Nonetheless, it would not handle the affected person wants of lowering their therapy burden, with one thing like a novel efficacy that is dosed as occasionally as 4 instances a 12 months. Every time the affected person has to take a tablet, thrice a day with Danicopan and even twice a day is with atacapan, the affected person, as we have realized from market analysis has to consider their illness versus dwelling their lives. Physicians inform us that they are moreover involved in regards to the threat of noncompliance with the orals, ensuing within the threat for breakthrough illness and a novel upstream therapy like OMS906 represents a patient-friendly possibility that actually places the efficacy into the physician’s fingers and the following confidence. So we predict it is addressing some small unmet wants, however the alternative for 906 actually is important.
Steven Whitaker
Thanks, Nadia. I may simply add medically that we solely see this as a validation the upstream goal. And for those who take a look at the info that we have disclosed to this point, we will have extra popping out of EHA, the place we nonetheless stay very excited in regards to the medical potential of treating these sufferers with OMS906 as a monotherapy.
Gregory Demopulos
Sure. So I thank, Steve. Andreas any?
Andreas Grauer
Properly, I feel the last word studying from that is additionally that it is a large market of the at present out there C5 inhibitors just isn’t assembly the wants of the PNH sufferers. They want one thing to handle the extravascular hemolysis and we predict OMS906 will do this higher.
Gregory Demopulos
Thanks. And Steve, I feel additionally a degree to underscore, I touched on it briefly, however simply to return again and ensure we emphasize it yet another time. It was Jefferies, the analysis group that got here out simply on the heels of the announcement of the approval pointing to peak annual gross sales of Danicopan at $750 million. And do not forget that, that’s going to be on high of C5 inhibitors. So it’ll be the price of Danicopan plus the price of eculizumab and/or ravulizumab. That is going to be a troublesome hill to climb. I feel actually, after we include a monotherapy in dosing each 8 to each 12 weeks, that addresses all the points that, frankly, the C5 inhibitors and Danicopan collectively are meant to deal with, I feel, will fare fairly nicely.
Stephen Brozak
Bought it. Thanks for ensuring you offered that readability. I very a lot respect it. Let me hop again into the queue. Thanks.
Operator
Thanks. [Operator Instructions] And our subsequent query comes from Serge Belanger from Needham. Your line is now open.
Serge Belanger
Hello. Good afternoon. Thanks for taking my questions. Greg, simply wished to return to narsoplimab and HSCT-TMA. Simply curious if there’s been a change in FDA stance right here across the path of resubmission, simply provided that the final time you spoke about this again in November 5 months in the past, simply appear to be near the end line. And now there’s clearly been some extra delays, however simply curious if that is an FDA change or simply the sluggish FDA course of? Thanks.
Gregory Demopulos
Sure. I feel the way in which that we are able to reply that’s I feel what we outlined, which was we submitted our SAP. FDA got here again with detailed questions. We responded with detailed solutions and the dialogue continues. I imply, actually, our expectation is that we have now glad what we have to fulfill for the Workplace of New Medicine path to each us and the division which, once more, was to one of many pathways was to have a look at survival, and we have finished that. And I’d say that the info we have now now collectively are stronger than the place we had been with the preliminary BLA submission, I feel, meaningfully stronger with respect to our survival. So we might want to proceed these discussions. We’re optimistic about the place we find yourself with this. I do know that no matter one is questioning is, when, when. And we would like to reply that with a selected knowledge. We do not have one proper now as quickly as we do, we’ll let you recognize. However I feel if you look once more on the knowledge that we have now, I feel it’s — one can be hard-pressed to make the case that the drug just isn’t working in PNH sufferers. That is my view. And I feel it is the view shared by the remainder of our workforce. In reality, I am fairly assured it’s. And I feel these discussions will proceed. And hopefully, that decision might be quickly.
Serge Belanger
Okay. Thanks.
Operator
Thanks. That completes the Q&Part of the decision. I might like to show the decision again over to Dr. Demopoulos for closing remarks.
Gregory Demopulos
All proper. Thanks, operator. And once more, thanks all for becoming a member of this afternoon. As at all times, we respect your continued help. Have an excellent afternoon or good night.
Operator
This concludes right now’s convention name. Thanks for collaborating. You might now disconnect.