Q3 2023 Omeros Corp Earnings Call
Good day, ladies and gentlemen, please standby the conference will start shortly.
Yeah.
Yeah.
Yes.
Gentlemen, please standby the conference Stuart Brian shortly.
Okay.
Okay.
Yes.
Good afternoon, and welcome to todays earnings call for <unk> 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 and please be advised that this call is being recorded at the company's request and a replay will be available on the company's website for one week from today I'll turn the call.
Over to Jennifer Williams Investor Relations for <unk>. Please go ahead.
Good afternoon, and thank you for joining the call today I'd like to remind you that some of the statements that will be made on the call today will be forward. Looking these statements are based on management's beliefs and expectations as of today only and are subject to change.
All forward looking statements involve risks and uncertainties that could cause the company's actual results to differ materially. Please refer to the special note regarding forward looking statements in the company's quarterly report on Form 10-Q, which was filed today with the SEC and the risk factors section of the company's most recent annual report on Form 10-K for a discussion.
These risks and uncertainties now.
Now I would like to turn the call over to Dr. Greg to marvellous, chairman and CEO of bone marrow.
Thank you Jennifer and good afternoon, everyone.
Today by Mike Jacobsen.
And Cathy Melfi, our respective heads of finance commercial and regulatory along with Steve <unk>, our VP of clinical development.
Andreas Grauer, who recently joined <unk> as Chief Medical Officer again welcome Andreas.
We'll have a brief overview of our financial results for the third quarter, followed by a corporate update.
Mike will then provide a more detailed financial summary, before we open the call to questions.
Our first though in the wake of our stopping the Artemis <unk> trial I'd like to address our near to mid term higher level program strategy.
To anyone paying attention to our programs in their development progress it should be clear that our company is strong and well positioned for success.
Of course, we're conducting a deep dive into our Artemis <unk> trial data.
And there's more work to be done there to learn what specifically happened.
Why we see an outsized placebo effect, whether there are subgroups of patients who responded well to in our supplement and how we can make use of newly developing biomarkers to understand better the role of lectin pathway inhibition in Iga nephropathy.
And in kidney diseases more broadly.
This examination will not only pay benefits to our master II program.
Including <unk> $10 29.
But will also help us design and execute clinical trials in kidney diseases for O. M. S 906 are masked three inhibitor.
While we expect to resolve these and other questions that we have on the Artemis <unk> trial, our top priorities are focused on near term value driving catalysts.
Specifically one.
Achieving approval and successful market launch for in our supplement and hematopoietic stem cell transplant associated thrombotic microangiopathy or Ta TMA mid next year.
Two.
Driving two phase III clinical trials for our masks III inhibitor on S 906, both in paroxysmal nocturnal hemoglobinuria or Pn, H and N C III Merial apathy.
Both phase III programs targeted to initiate in the third quarter of next year.
Three moving Oems 10, 29, our long acting <unk> two inhibitor into phase II clinical trials by next summer and a larger market indication.
And for taking our current cash runway.
Projected to be well into 2025.
The extended well into 2026 or beyond without dilution to shareholders.
We believe that each of these four strategic objectives can be achieved in parallel we remain laser focused on cost containment and are assessing a range of additional cost reduction measures for implementation, while balancing them with ensuring that we invest.
The necessary resources to achieve our near term value driving objectives.
As part of these cost containment efforts the funds previously earmarked for the two year continuation of the Artemis <unk> trial and related commercialization will be reallocated to extending our runway and to our other later stage programs with a good part of that.
Acacia going to accelerate and broaden development of Oems 906, or alternative pathway targeting masks three inhibitor.
To summarize the bulk of our development expenditures in the near to mid term will be directed to approval and market launch of <unk> and Ta TMA driving Oems 906 towards successful completion of its phase III clinical programs and proving the value of all of them is $10 29.
Our <unk> seven inhibitor <unk> five to seven will continue advancing through its multi year funding.
The National Institute on drug abuse or neither.
In addition, we intend to move ahead with certain work advancing the seminal discoveries in our immuno oncology program are spending on these programs has been relatively small to date.
As the large majority of the efforts across our five novel I O platforms are conducted in house by a relatively small but extremely effective group of scientists.
We believe that a limited additional investment in these programs could catalyze significant asset value in the programs potentially in the near term.
Now, let's turn to our financial results, our net loss for the third quarter of 2023 was $37 $8 million or <unk> 60 per share.
Compared to a net loss of $37 $3 million or 59 cents per share in the second quarter of this year.
Cash burn for the third quarter of 2023 was $31 million.
Omidria royalties for the third quarter were $10 million and that's a $700000 decrease over second quarter royalties.
This is consistent with historically fewer cataract procedures performed during the summer months.
As of September 32023, we had $310 $3 million of cash and investments on hand.
<unk> has $95 million of convertible debt maturing November 15 of this year.
Which we plan to retire.
Even after retiring the 'twenty two 'twenty three notes our current available cash and investments should enable us to fund our operations and continue advancing our multiple programs well into 2025 and as I noted just a few moments ago, we are evaluating options to extend that runway.
A non dilutive way well into 2026 or beyond.
Last week CMS issued the final rule for its 2020 for hospital outpatient prospective payment system.
In that rule CMS recommitted to separate payment for Omidria and ambulatory surgery centers or <unk> throughout 2024.
Beginning January one 2025 as mandated by Congress in this year's consolidated Appropriations Act CMS will pay separately for Omidria in both hospital outpatient departments and in Afg's until at least January one 2028.
Yes.
Historically, when Omidria is separately paid and hospital outpatient departments Omidria sales in those facilities have represented an additional roughly 33%.
On top of sales in afcs.
Let's turn now to our program updates starting first with our family of agents targeting <unk> two the effector enzyme of the lectin pathway of complement on October 16, we announced genuinely surprising and disappointing preliminary results of the pre specified interim.
Dallas, and our phase III Artemis <unk> trial of <unk>.
<unk> in our supplemental <unk> for the treatment of Iga nephropathy topline results.
<unk> that in our supplemental did not reach statistically significant improvement over placebo on.
The primary endpoint of reduction in proteinuria assessed by 24 hour urine protein excretion at 36 weeks in.
And the intent to treat population comprised of 180, <unk> Iga nephropathy patients all of whom had baseline proteinuria levels above two grams per day, so severe iga patients.
Based on the absence of a statistically significant improvement on the proteinuria endpoint and as agreed with FDA.
The clinical trial has been discontinued.
As we noted during our conference call on October 16, the proteinuria reduction observed in the placebo group was substantially greater than in phase III clinical trials on other agents and Iga nephropathy.
Had the placebo effect in our trial been consistent.
With the placebo effect in those other trials our trial would have met statistical significance.
Our deep dive analysis of the Iga data from our trial is underway.
As I mentioned a bit earlier, what we learned from that analysis should be applicable not only to our mass to lectin pathway programs, but also to our programs for our alternative pathway masked three inhibitor <unk> hundred six.
Remember that alternative pathway inhibition has now been clinically validated as an effective treatment for kidney disease.
And this bodes well for <unk> 906.
And it's expanding range of potential indications.
So despite the outcome of Artemis I again, the evidence supporting the role of the lectin pathway and kidney disease.
Therapeutic potential of mast two inhibition remains strong.
That said any future development of elected pathway inhibitor for Iga nephropathy are other indications that similarly require long term chronic dosing are better suited for O M. S $10 29, our next generation.
Long acting masked two inhibitor.
<unk> 29, a successfully completed a phase one single ascending dose study in healthy subjects.
And the resultant pharmacokinetic and pharmacodynamic or PK PD data.
To support dosing of Oems $10, 29, once quarterly either subcutaneously or intravenously.
Phase one multiple ascending dose study of <unk> 10, 29 is ongoing.
And we expect to initiate next summer Ah Phase III program for all of them is $10 29.
Another of our four near term strategic objectives, the approval and successful market launch of <unk> for patients with Ta TMA.
Is right now a key focus of our company.
We have submitted to FDA, a formal statistical analysis plan to compare survival from our in our supplement <unk> pivotal clinical trial.
To that of an external control specifically, a large registry of Ta TMA patients.
The statistical analysis plan was developed by a well respected biased statistical group independent of <unk> and without having examined the survival data to be used in the comparative analysis.
Assuming.
FDA agrees with the plan, we expect the bio statistical group to conduct the analysis and if the results are supportive.
We intend to resubmit, the biologics license application or BLA for <unk> in Ta TMA soon thereafter.
Which should allow for an FDA decision on <unk>.
An approval mid next year.
To minimize the time to an approval decision we've already begun revising those modules of the BLA resubmission that require revision.
That includes revising the CMC module of the BLA in accordance with the agreements reached during our meeting last month with FDA CMC review team assigned to our BLA.
We also intend to include in our BLA Resubmission real world data on over 128, Ta TMA patients treated with <unk> under our compassionate use program.
For each of these adult and pediatric patients.
We have provided in our supplement are at no charge.
Well not financially sustainable long term.
As compassionate use results show more and more evidence of strong survival outcomes, we feel an increasingly strong obligation to.
To provide access to in our supplement for high risk Ta TMA patients while the drug continues to proceed.
Through the regulatory process.
The outcomes of a.
Large number of compassionate use ta TMA patients treated with our supplement have been reported in peer reviewed journal and International Congress publications.
The patients have ranged in age from three months.
Two over 70 years the.
The most recent publications and abstracts to be presented at the upcoming annual meeting of the American Society of Hematology.
Details of the clinical and survival benefits of <unk> in <unk> adult and pediatric compassionate use patients 14 of whom had high risk Ta TMA.
73% were deemed responders with 100 days survival achieved by 80% of all patients in the study and buy 100% of the responders.
As in all other studies in our <unk> was generally well tolerated without any safety signals of concern.
Our work with <unk> in Covid, 19, and acute respiratory distress syndrome or Rds.
Presents another opportunity for continued development of our supplement or in a group of indications centered around <unk> for which there is strong and widely published mechanistic evidence as well as proof of concept clinical data.
And our <unk> is particularly well suited for diseases like <unk>.
Acute indications requiring hospitalization.
We continue making significant progress in further characterizing the lectin pathways central role in COVID-19, and <unk> two weeks ago. A manuscript was published in the journal of infectious diseases, describing the benefits of mast two blockade and lectin pathway inhibition.
<unk> disease, lungs, and brains as well as on survival and a well established animal model of COVID-19 related Rds.
Treatment of infected mice with a mask two inhibitor significantly reduced disease severity scores and improved survival rates compared to the control antibody.
Specifically mask do inhibition significantly reduced lung infiltrates edema and hemorrhage.
While also significantly reducing and normalizing brain inflammation and associated hyper activation of brain microglia.
Discussions continue.
With U S government agencies around both COVID-19 and Rds.
Multiple labs have recently identified lectin pathway hyperactivity is prominently present in patients with long Covid at both six and 12 months following resolution of their acute Sars COVID-19 two infection.
Here again, the data suggest a potential rollover in our supplement have been masked two inhibition in the treatment of not only acute but also long COVID-19.
To date, the challenges and assessing a therapeutic and long COVID-19 or the lack of standardization in diagnostic criteria and in clinical endpoints.
Progress is being made internationally on both fronts and we are assessing next steps.
In parallel we have developed published and filed abroad.
Broad patent internationally on an assay platform that can identify and discriminate between mild COVID-19 patients and those who have moderate or severe COVID-19, requiring hospitalization.
As novelty and core measurement is the mask two C. One inhibitor complex.
A highly sensitive and specific marker of lectin pathway hyper activation.
We believe that this assay has the potential to predict those patients who have a high likelihood of progressing to severe COVID-19 and COVID-19 related a rds.
This would be a win win for patients physicians and the payer system.
We also believe that our assays utility could well expand beyond acute COVID-19 to include.
Both long Covid.
And other disease related <unk>.
To our knowledge there is no commercially available assay that can similarly identify at risk patients and acute COVID-19 long COVID-19 or rds.
We're evaluating our options for completing development and commercialization of this assay.
We've also made good progress in our orally administered <unk> two inhibitor program our objective across the masks to franchise is to control exclusively.
For the full range of therapeutics for lectin pathway related diseases and that includes oral therapies.
We have selected a drug development candidate as well as a backup candidate both of these orally delivered.
And testing to enable the filing of an investigational new drug application is underway.
Okay, Let's now focus on Oems 906, our lead antibody targeting mass or in the alternative pathway of complement.
Inhibition of the alternative pathway continues to be validated clinically by other alternative pathway inhibitors in a wide range of diseases.
This growing set of indications in years, two the value of our unmatched 906.
Recent examples of this are the clinical validation of alternative pathway inhibition in Iga nephropathy.
And in geographic atrophy.
And our <unk> program, we previously disclosed encouraging data from an interim analysis in our phase II clinical trial evaluating <unk> 906 in pn patients.
Who have not previously been treated with a complement inhibitor.
An abstract with new and updated data from this study.
Treatment naive <unk> patients has been selected for oral presentation at the annual Congress of the American Society of hematology or ash.
Coming up this December.
The presentation describes the clinically meaningful beneficial effects of <unk> 900, <unk> on hemoglobin, LDH and Red blood cell clone size and <unk> patients.
11 patients are enrolled in this study all of whom had reached the four week time point and three of whom had reached the 24 week time point at the time of interim data capture.
Following initiation of <unk>, 906 mean hemoglobin increase from baseline by three one grams per deciliter at Borgwarner at four weeks.
And by nine five grams per deciliter at the latest time point of 24 weeks.
All but three of the patients achieved gender specific normalization of hemoglobin levels.
The remaining patients had concomitant diseases, causing bone marrow suppression of red blood cell production.
Unrelated to PSNH.
But preventing normalization of hemoglobin levels.
No patients required transfusion following <unk> 906 treatment mean.
Mean, LDH levels decreased from baseline by.
By approximately 1500 units per liter at four weeks and by nearly 2000 units per liter at 24 weeks.
Mean, PSNH RBC clone size increased by up to 39% versus baseline.
Our second Oems 906 abstract was also accepted for presentation at Ash. This one is directed to in vitro and in vivo mechanistic support for the clinical efficacy of <unk> 906 <unk> patients.
Our second phase II study in <unk> patients our switch over study.
Is now fully enrolled as designed this study enrolled <unk> patients receiving the C. Five inhibitor Ravi Iliza map ads on that 906 to provide combination therapy with Raviolis Mab for 24 weeks and then in those patients who demonstrate a.
Hemoglobin response with the combination therapy switches to <unk> 906 mono therapy.
We anticipate sharing data publicly from this study later this year or early next.
As part of our strategy to move as rapidly as possible through clinical development of <unk> 906 in this indication.
We have now initiated an extension study designed to assess the long term efficacy and safety of all <unk> 906 <unk> patients.
The study will enroll patients who have completed either of the two phase two studies that I've just described.
Which both evaluate Oems 906 for the treatment of <unk> patients will roll from either of those trials directly into the extension study without a break and almost 906 treatment.
Data from this study will contribute to the planned BLA for <unk> 906, and the treatment of <unk>.
In addition to our clinical work in Pn H, we have an LMS 906 phase two clinical program ongoing in <unk>.
A rare and debilitating kidney disease enrollment for this trial is slated to begin next month.
Consistent with our prioritized objectives, we are targeting to begin enrollment in our phase III <unk> trial and in our phase III <unk> trial in the third quarter of next year.
Yes.
The latest <unk> 906 data now made public by Ash in advance of the presentation at these societies annual Congress in December.
AD.
Two the compelling case that masks III might well be the premier alternative pathway target and <unk> 906, the premier alternative pathway drug.
We previously have detailed that we see as the major differentiators between masked Marino M. S 906 versus other alternative pathway targets and therapeutics.
On the market or in development.
I won't repeat those detailed explanations of their advantages.
They can be found.
In transcripts of earlier calls and in our slide presentation on our website.
Instead, I'll simply summarize the highlights and they are as follows one.
<unk> blockers do not inhibit the infection fighting function of the classical pathway of complement by contrast, both <unk> three and <unk> five inhibitors block the classical pathways adaptive immune response.
Thereby increasing infection risk too.
Two masks III is no not to be an acute phase reactants and has very low native circulating levels relative to other alternative pathway targets. In contrast factor B C. Three and the terminal factor XI.
Five are all acute phase reactants. This means that the concentrations of factor B C. Three and <unk> five increase in the setting of inflammation such as infection.
Or any other inflammatory condition as a result.
906 should maintain more consistent pathway inhibition than drugs targeting factor B C three or five.
Providing better protection against potentially life, threatening breakthrough of Ah patients underlying disease.
And three Oems 906 should deliver better patient convenience and compliance than the competition.
By allowing once quarterly intravenous and subcutaneous administration.
While we expect these three major advantages to provide significant differentiation over our competitors those competitors also help us there.
They help us by continuing to validate indications clinically providing a derisked roadmap for us to follow with what we expect is a better target.
<unk> III.
And a better drug arms 906.
So the data around to almost 906 continue to strengthen and the breadth of potential indications continues to expand.
As a result, the value story for the entirety of the 906 program continues to improve.
Our objective remains unchanged.
To make <unk>. The first line standard of care for the treatment of <unk> and a host of other alternative pathway diseases and disorders.
Let's now move onto all of them as five to seven or <unk> seven inhibitor program targeting treatment of addiction, and compulsive disorders <unk> seven inhibition has been shown in animal models to block, both craving and relapse across multiple substances of abuse, including opioids cocaine nicotine and <unk>.
Alcohol importantly, <unk> seven inhibition. Unlike other anti addiction agents on the market.
It does not appear to depress the reward system, a depression of the reward system results in diminished enjoyment of other life activities food socialization sex sports.
And is a major cause of noncompliance with currently marketed anti addiction agents.
Ability of PD seven inhibitors to avoid this side effect.
Represents a significant advance in the treatment of substance use disorders.
Potential indications for PD inhibitors are not limited to substance use disorders, but extend to compulsive disorders.
With clear efficacy data in a well established animal model of binge eating.
The development of our PD seven inhibitor program for addiction is currently fully funded by a grant from the National Institute on drug abuse, $6 7 million over three years. Neither requested that we first develop <unk> $5 57 for the treatment of adults with cocaine use disorder.
The grant supports both preclinical and clinical work, including a randomized double blind inpatient clinical trial.
In addition to the treatment of addiction, and compulsion, so merrill's controls broad patents surrounding <unk> seven inhibition in movement disorders.
Our clinical focus and movement disorders, as the potential treatment of levodopa induced dyskinesia or L. I D.
<unk> is a nearly universal and debilitating side effect of long term treatment with L. Dopa in patients with Parkinson's disease.
Housing crippling and involuntary movements and L dopa treated patients.
It is estimated to affect millions of Parkinson's patients worldwide, representing both a large unmet patient need and market opportunity.
The only approved drug for ideas marginal efficacy and is fraught with significant adverse side effects.
A more effective and safer treatment is needed.
Primate studies assessing all of them as 5% to 7% and our idea of been conducted at Emory University.
And we are discussing next steps with our Emory colleagues.
We will end today's corporate review with our immuno oncology programs are broad Io franchise consists of two cellular platforms and three molecular platforms.
Our two cellular platforms, our car T in adoptive T cell therapy, or three molecular platforms, our immuno modulators immuno toxins in cancer vaccines.
All of these five platforms are entirely novel.
And based on substantial in vitro and in vivo data all look to be viable.
During our last quarterly call I described each of these five programs.
In the interest of time I'll focus on only two our adoptive cell therapy, and our cancer vaccine platforms, specifically, what we believe will prove out to be their respective major advantages over competitive programs.
Our adoptive cell therapy platform or ACP like our car T platform is based on the novel identification of specific T cell signaling pathways, which one's inhibited.
Significantly and preferentially potentiate and enhance the expansion of tumor specific memory T cells. These tumors.
Tumor specific memory T cells, distinctively recognized and efficiently kill tumor cells.
The potential advantages of our AC platform over other cellular approaches are one.
Rather than targeting just cell surface antigens or <unk> T platform is designed to target both cell surface and intracellular cancer antigens significantly broadening its range of indications.
Two instead of increasing predominantly.
Either CD four or CDA T cells, both of which are needed to successfully kill the tumor.
Our ACD technology markedly increase those levels of both CD, four and CDA cancer specific T cells.
This should lead.
Two more effective anti tumor responses. In addition, the increase in memory cells is expected to mitigate the treatment exhaustion or the wearing off of the treatment effect.
With many currently available cellular therapies. This would result in the ability to treat the tumor repeatedly and prevent relapses.
Unlike existing car T therapies, our ACD technology does not require cellular engineering.
Instead <unk>.
<unk> from the patient are simply treated outside the body and administered to the patient.
This would represent a major advance over currently available T cell therapies markedly decreasing both cost and preparation time together.
Together with enhanced efficacy by enabling multiple repetitive administrations.
The expected result is better and sustained anti tumor response.
As with our other.
Molecular I O platforms, immuno modulators and Immunotoxin, we're excited about the potential of our cancer vaccine platform as well.
And the potential for that platform to have a significant impact on the survival of cancer patients.
Though widely pursued a successful development of therapeutic cancer vaccines remains difficult to achieve.
Okay.
Current approaches.
Induce only transient and ineffective immune responses.
We believe that we have discovered a way to overcome this challenge.
<unk> generated novel molecules that combined tumor antigens with a potent adjuvant. These biologic molecules activate antigen presenting cells. This ultimately leads to efficient killing of tumor cells by both T cell and antibody mediated activities.
The vaccine also promotes.
Long lasting immune response through the generation of memory T and b cells the.
The major advantages of our platform over other vaccine approaches are one our platform should be applicable to all or nearly all tumors.
And two when injected into the body our novel biologic molecules should result, not only in elimination of tumor cells, but importantly, an immune memory against future cancer relapse.
If needed this immune memory could be further enhanced with subsequent vaccine boosters.
As I noted earlier today, the large majority of the efforts across our five novel cellular and molecular platforms are conducted in house by a relatively small but highly effective group of scientists, we believe that the moderate investment required to continue advancing our I O.
Program could create opportunities for meaningful non dilutive funding.
So I'll now turn the call over to Mike Jacobsen, Our Chief Accounting officer to go through a more detailed discussion of our third quarter financial results, Mike Yes. Thanks, Craig.
Our net loss for the third quarter was $37 $8 million or <unk> 60 per share compared to a net loss of $37 $3 million or <unk> 59 cents per share in the second quarter of this year.
Cash burn as Greg mentioned for the third quarter was $31 million.
As of September 30th 2023, we had $310 million of cash and investments on hand.
And $7 million in receivables, primarily consisting of the midway royalties.
Cost and expenses from continuing operations for the third quarter were $48 2 million, an increase of $7 $3 million from the second quarter of this year.
The increase was primarily due to a licensing milestone payment made in connection with our Oems 906 program and compensation expense.
Interest expense for the third quarter was $7 9 million consistent with the second quarter of this year.
The primary drivers of interest expense are the 2023 and 2026 convertible notes.
And our Omidria royalty obligation to Dr Ray.
Our 2023 notes totaling $95 million are due next week.
We plan on retiring the notes with a portion of our existing cash and investments.
Now, let's look at Omidria royalties under our contract with Rainer, we are entitled to receive royalties on net sales of Omidria for the <unk>.
<unk> of the relevant patent terms.
In the U S now extend into 2035.
Under the terms of the contract the political royalty rate decreased from 50% to 30% of U S. Net sales upon earning the $200 million milestone payment at the end of last year.
The 30% royalty rate will continue to apply while separate payment for Omidria is in effect and while sales of omidria have not been materially affected by the entry of a generic competitor.
Under our settlement agreements with the generic manufacturers.
We do not.
<unk> generic entry into the market until 2032 at the earliest.
But should generic entry occur in 'twenty <unk> two.
Any such generic would be at risk of infringing. The recent issued patent that extends to 2035.
As previously mentioned separate payment for the Omidria for separate payment for Omidria will continue under statutory mandate until at least January 2028.
For the third quarter.
Our royalties on Omidria net sales were $10 million down $700000 from the second quarter.
This is consistent with the historical data lie decline in cataract procedures during the summer months.
Royalties earned are recorded as a reduction in our.
Imagewear contract royalty asset on our balance sheet.
Income from discontinued operations in the third quarter was $13 $9 million and includes two primary components.
$3 $7 million of interest earned on the Omidria contract royalty asset.
And $10 $1 million of income due to remeasurement adjustments on our omidria contract royalty asset.
Measurement adjustment.
As expected incremental Omidria net sales during the term.
Now, let's take a look at our expectations for the fourth quarter.
During the fourth quarter, we will incur various costs to close out the Artemis <unk> trial. Additionally.
Additionally, we expect our manufacturing spend on <unk> 906 will increase as will our cost for the well.
<unk> 10, 29 clinical trials.
These increases are offset by the Oems now have six development milestone we incurred in the third quarter.
Overall, we expect fourth quarter R&D costs to be similar to the second quarter just completed.
Fourth quarter, SG&A cost should be consistent with historical levels, which have been in the $12 million range.
Interest income in the fourth quarter should be approximately $2 $5 million.
The decrease from the third quarter reflects the use of $95 million of cash to retire the 2023 notes.
Interest expense for Q4 will be approximately $7 million down 900000 from the corps third quarter due to the November 15th retirement of the 2023 notes.
Income from discontinued operations for the fourth quarter should be approximately $6 million.
With that I'll turn the call back over to Greg Greg.
Thanks, Mike operator.
Let's open the call to questions.
And you can choose.
And ladies and gentlemen question you grasp on one one on your telephone.
Question. Please press star one.
And standby with Keybanc.
Your first question comes from the line of Steve <unk>.
I'll start with <unk> Securities. Your line is now open.
Hey, good afternoon, and thank you for taking questions.
There is a word that keeps coming up compassionate use and you mentioned it a couple of times, obviously in the number of patients who had been trading but also as far as in the ash.
Document that is being published can you can you go into as much detail as possible on that please.
Sure.
Hi, Steve sure we went through I think.
The data from.
That compassionate use.
Abstract during the prepared comments.
But I can summarize those for you.
These were <unk>.
<unk> compassionate use patients they were adult and children 14 of them were high risk.
When we look or when those investigators look at those.
At those patients.
The response rate was high.
The 100 day survival across the study was 80%.
So that's all patients in the study, including non responders on when you look only at responders.
Survival rate.
Was 100% so again.
Similar to what we had seen in our pivotal trial.
And we.
We think again consistent.
And kind of clearly underscoring.
The role of lectin pathway inhibition in this disease.
We have as we mentioned.
Over 120 patients that we have treated with compassionate use our software.
Many of those are from sites.
That have put in multiple requests so if you're getting multiple requests from a large number of sites you would expect that.
That those sites are having success with the treatment otherwise I would expect you would not receive.
Multiple requests.
Further to that point.
You have to think about the patients for whom compassionate use <unk> is being requested these are these are for the most part.
Obviously very sick patients they may be patients or in the case of a good number of these they are patients who have failed <unk>.
Prior treatments, either with <unk> Mab Raviolis Mab Defib retired.
She had a coke plant.
And.
We are being asked effectively to catch a falling knife.
We do not deny treatment.
We tried to get the treatment there as quickly as possible. So I think the results are even more impressive.
Given what we would expect to be the severity of the patients and the fact that a good number of them have failed.
Prior treatment with other.
Off label.
Drugs and then we see this response with in our supplement.
That I guess, you could explain that if it happened once it could be.
Just chance.
<unk> two may be enacted God, but at some point the number of those patients responding to in our supplement.
I think really point to.
What the drug is doing.
To help these patients and that's why we.
We genuinely believe its important and we make it available.
It is at our cost and that cost is substantial.
So you know.
We want to continue to do it throughout the.
Throughout the regulatory process, but at some point it really does become I think untenable.
Okay.
But we try to do we tried to do what we can here.
Just just along those lines and I'll hop back in the queue. Thank you the clinicians because youre mentioning these patients that are obviously critical and critical straights. The clinicians what are you know I'm sure that these are the people that have been convinced so what feedback are you getting from them and I'll hop back in the queue. Thank you.
Yeah, It's a good question.
Clearly, we're receiving positive feedback from them and that feedback is not only coming to us it's being it's being put in.
In two abstracts and potentially publications.
Our already published.
On these patients and their responses. So this is this is what we're this is what we're seeing and this is it is.
All consistent I guess would be my my point and I think.
If you look at the data I think those are pretty clear.
Got it thank you I'll hop back in the queue.
Okay.
And your next question comes from the line of Serge Belanger with Needham. Your line is now open.
Hey, good afternoon.
<unk>.
One question for Us on HFC T TMA.
What kind of feedback are you expecting from FDA.
Regarding the analysis plan and is this something that could drag.
Nir and this year thanks.
Yeah, Hi, Serge.
Look I think clearly.
What we hope to receive from FDA.
His acknowledgement in alignment on the statistical analysis plan, that's been submitted as I as I stated earlier. This analysis plan has been put together and not <unk>.
But by an external and very well well respected well known.
Bio Statistical group.
We believe that it is frankly conservative.
We think it should be acceptable.
So what we are hoping to hear back.
In the near term.
Is that.
The.
Approach that has been proposed is acceptable. We can go ahead and run the analyses, which have not yet been run.
And <unk>.
Based on the outcome of those analyses if those analyses are supportive of a BLA, we will resubmit the BLA.
So with respect to timing.
I think what we have guided to.
Is what we continue to hold to and drive too which is we are <unk>.
Really pushing.
To get an FDA response.
On a resubmitted the BLA in mid next year, which would be followed very shortly thereafter by the commercial launch of <unk> for Ti T M.
Did that did that answer your question Kathy do you want to add anything to that or undress her or Steve.
So sure.
Very good.
Oh go ahead surge asking then and then.
Alright.
So re filing it's still pending.
Analysis of the data.
That hasnt been completed at this point.
Sure we have not we have not analyzed the data.
We have built the analysis plan or I should say are our external bio statisticians have built the analysis plan.
But we are waiting.
To get alignment with FDA. So that we can we can analyze those data and it is then done.
Without foreign knowledge of the outcome that has been.
That's been our approach we think it's the right approach frankly the analysis.
After having built the programs.
That analysis should take one to two two days to complete so that's not going to be a a.
Any kind of meaningful time delay.
And moving forward, but Kathy do you want to add to that sure.
I think you had asked about.
What feedback we expect that circuit thing.
And the plan that we've put together that proposal is consistent with the feedback that we received not just from the office of new drugs, but following a meeting that we had with the review division in the summer and also as you May know FDA has come out with a lot of recent guidance documents on use of external control groups and real world data.
And our proposal is consistent with all of those things so.
We feel confident in what we propose to FDA and we are.
Wait there a response.
Thanks, Ken Thanks for clarity.
Alright, thank you.
Andreas anything you wanted to add to that.
No I think that sums it up.
We're awaiting FDA feedback and are excited to interact with them on this.
Great. Thank you.
And we have a follow up question from Steve brought back.
Your line is now open.
Hey, Thanks again for taking the follow up.
The question just can't.
In terms of.
Your plan as far as following up on the Statistical review.
But just to go over everything you've got in terms of other items in our submission CMC and everything else. Those you have and I have prepared concurrently so there would be no delay by anything that you would see.
With that and just to go over that.
You would be you would be basically looking at that as something that would would frankly be already accomplished is that correct as well.
Yes.
Okay.
We have been in the process of assembling all of the information that we plan to include in the Resubmission.
In direct answer to your question none of those should represent any kind of delay.
So again.
As Kathy pointed out.
Everything that we built in or was built into the analysis plan is really consistent with the guidance. We have received not only from the division not only from the office of new drugs, where you recall, we had appealed the initial CRO, but also with the.
Our guidance documents set forth by FDA.
Uh huh.
In the in the recent past.
So we think we have done what we need to do.
The pieces of the BLA or are coming together now we don't want to delay.
So we don't see any of those other components, resulting in a delay.
Got it great. Thank you for that further clarity.
Thank you so much and there are no further.
At this time I would now like to teleconference updating markets forgive me.
Alright. Thank you thank.
Thank you operator, and thank you all for joining this afternoon.
Everyone at <unk> is working hard to recover.
Sustain and ultimately grow value for our shareholders following the Artemis <unk> results.
I hope that today's presentation helped to identify the opportunities for value creation across our late stage and even our earlier stage programs I.
I remember for those of you who have or can obtain access to ash either in person or remotely.
The phase two clinical update on our <unk> 906 program will be presented by a doctor John's ponds on Sunday December 10th at five PM Pacific time.
The presentation will provide a good sense.
Where our mask free alternative pathway inhibitor program stands relative to other <unk>.
Alternative pathway inhibitor programs.
As underscored today, we believe that we control the premier target in mass and the Premier Dragon <unk> 906, and the alternative pathway space.
The other two ash abstracts on our programs one detailing the outcomes of the high risk Ta TMA patients treated with in our supplement are under compassionate use that we were just discussing in the other describing the mechanism mechanistic support for masks three inhibition and <unk> those both up.
<unk> will be presented on Sunday December 10.
And then Monday December 11, respectively.
The time slot for both is six to eight P M Pacific time.
Details of all presentations can be found in our press releases issued on November 2nd and on November 3rd.
So with that.
Thanks, again and as always we appreciate your continued support.
Have a good day. Thank you.
Thank you for centuries, and this concludes today's conference call. Thank you for participating and you may now.
Have a good day.
Okay.
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Yes.
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