Q3 2023 Ocuphire Pharma Inc Earnings Call & Bussiness Update Call
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Greetings welcome to Oxy fired pharma incorporated corporate update call, let's see Oh Doctor George Mcgrath at this time all participants are in a listen only mode. A question and answer session will follow the formal presentation. If anyone should require operator assistance during the conference. Please.
Press Star Zero on your telephone keypad. Please note. This conference is being recorded I will now turn the conference over to Michael Wood of Life Science Advisors.
You may begin.
Thank you before we begin we want to draw your attention to the legal disclosure regarding forward looking statements. During the course of the carpet is called the website. The company will make forward looking statements regarding future events, including statements about financial and clinical milestones potential future milestone payments.
Basically on plan and strategies and trends.
The remainder of 2023 and beyond we encourage you to review the company's past and future filings with the SEC, which identify specific factors that may cause the actual adults or events to differ materially from those described in the forward looking statements you can find the SEC filings.
Edgar database.
You can see that our army maturation section of occupiers corporate website occupier dot com.
Please note that any comments made on today's call may speak only as of today's date December 5th 2023, and may not be accurate at the time of any replay or transcript reading.
I'll now turn the call over to Dr. <unk> Grout. Please go ahead.
Thank you Michael for the introduction and good morning, everyone and thank you for joining I'm very pleased to address you today as the recently appointed CEO of occupier, it's with great excitement and a deep sense of responsibility that step into this role Ali.
Also on the call today are Charlie Hoffman, our senior Vice President corporate development and Ronald Patel, Our Chief business Officer, both will be available to answer questions. During the Q&A session.
I have experience as both an eye care professional and in senior leadership roles within the health care industry before I discuss our plans and occupier, let me spend a few minutes on my background.
I received my medical degree from the medical University of South Carolina were also completed a residency in ophthalmology I think.
And completed a fellowship at the Wills Eye Hospital in Philadelphia.
I also have an MBA from the cereal.
In Charleston, South Carolina, and a masters of science in applied economics from Johns Hopkins University.
It works in numerous corporate roles within the health care industry, including as an equity analyst and in drug development and a pharmaceutical services.
Most recently I had the privilege to serve as CEO of let's toss pharma services and ophthalmology contract research organization that provided clinical trial and medical strategy services to a large companies large pharma and biotechs in ophthalmology.
It makes the task I led a team that was responsible for growing annual revenues four fold in two years.
The growth of the company from 45 employees to almost 200 broadened the number of business lines and triple the number of trials, we had under management, 75% of those were in the retina space.
I was successful in negotiating favorable exit through an acquisition with T H capital.
Transaction that realized significant returns for investors.
I gave a lot of thought to my next career move and took the time to carefully evaluate a number of options since the transaction was completed.
When the opportunity occupier was presented to me it immediately stood out as a company I saw as already on the path to becoming one of the leaders in the ophthalmology space.
There aren't too many small biotech companies that have succeeded in achieving FDA approval for their first NDA and also executed clinical trials with the efficiency that I witnessed the occupier.
I was very impressed by how resume V had advanced through both clinical development and the FTA approval process in a relatively short timeframe I saw this as a demonstration of the capabilities of a very competent organization.
Furthermore, the companies need a fabric asset a T X 33 30.
And even more exciting commercial opportunity.
If approved this is a drug that could truly change the treatment paradigm for diabetic retinopathy, which is the leading cause of blindness in working a generic.
The other key factor for my decision to join Occupier is the existing management team.
As investors you will understand that the fortunes of everybody a tech company are determined to a large extent by the people who are running the business. So I'm very pleased to be working with a group of very capable individuals who have proven themselves and the ability to execute on drug development and strategic licensing efficiently and effectively.
You know I see a fantastic opportunity to leverage my business the medical backgrounds to help build out an already exceptional organization is committed to helping patients and creating value through innovation.
Archie fires now are at an exciting stage and my immediate priority as CEO is to develop and implement a strategy you can take the company to the next logical phase of maturation in order to maximize value for shareholders.
We have the gifts fortunate of only two important ophthalmic assets.
But we intend to focus our resources on the retina program E. T. F 33, 30 cents for Adobe is now in the very capable hands of our partners at Beatrice.
The FDA approval.
This past September was an important milestone for occupier.
We see this product and other phentolamine programs.
As being valuable assets and a source of future cash flow as you know that's been told me product where license to be interest under global agreement signed with occupier in 2022 and these programs are now essentially in their hands.
We have a very strong relationship with via truth and continue to work with them.
Page Iraq, the clinical development for treatment of Presbyopia, and Tim like disturbances.
Now moving onto EPS, 33, 30, which is clearly the future of occupied.
No one would disagree there's a vast opportunity for a drug that could effectively and safely treat non proliferative diabetic retinopathy with the convenience of an oral tablet.
Outcome of our rent a reset in the phase two meeting means that hockey fire has a clear path to develop a truly game changing drunk and I'm excited by the opportunity to lead this effort.
I know from my own practice about the challenges of treating diabetic retinopathy and the devastating impact that it can have on patients.
The number one cause of blindness in working age adults and frequently affects people in their working years, particularly the thirties forties.
Patients who progressed to advanced disease are left with a disability for the rest of their lives.
I also know all too well that they're currently no suitable treatments being used in the segment of the population that has been diagnosed with more moderate disease.
Aps thirty-three 30 offers the promise of an oral agent that can slow the progression of non proliferative diabetic retinopathy to proliferative diabetic retinopathy.
It has a unique mechanism of action that reduces both abnormal angiogenesis and inflammation.
It does not deplete.
You bet Jeff.
Ted It reduces digest the normal excuse me your logic levels.
If we can confirm the results from the Veda, one phase two study and our phase III program and S. E. T X 33, 30, a subsequently approved it would provide physicians with a valuable new preventive therapeutic option.
It would potentially be the first product that could be widely used in a large number of patients who are earlier in the course of disease and who are still asymptomatic.
This would offer a completely new paradigm and potentially reduce the number of patients who eventually progressed the devastating complications ambitions.
The analogy I like to use the same cardiovascular disease, where it's a lot more effective to treat patients who have high blood pressure or high cholesterol rather than waiting for someone to have one of the devastating downstream effects, such as a heart attack or stroke.
The commercial opportunity in diabetic retinopathy as compelling their estimated 8 million patients in the U S who have progressive disease.
The recent dramatic being any of that Jeff agents are efficacious, but the majority of moderate to severe patients with D. R are not treated with anti VEGF D to the injection burden and the lack of benefit on immediate visual acuity.
As a result, the standard of care.
Is watching weight physicians do not have any non invasive option.
Our game plan over the next 12 months is to prepare for and initiate Registrational phase III trials to support an NDA for a T X 33, 30 N D R.
The team here at Occupier recently has.
Held a successful end of phase two meeting with the F D. A.
During which they reached agreement on the primary endpoint for the phase III, which will be a three step worsening on a buying ocular diabetic retinopathy severity scale.
As a next step we plan to something special protocol assessment to formalize our agreement with the FDA on the clinical trial protocol and statistical analysis plan for the Phase III program.
This will ensure that we are in sync with the agency on the key elements of the trial and we believe it will reduce uncertainty and de risk the regulatory aspects of the program.
We hope to have the spa in place early next year and will share specifics on the study design parameters and timing once agreed upon with the FDA.
Our goal is to begin the clinical study in the second half of 2024.
The other important area I intend to focus on in the near term as management.
As I said there is an existing team here, that's very capable, but there are a few key positions that we need to sell.
Yeah.
Very recently, we hired Joe Shackle as Chief operating Officer, who is an industry veteran with extensive operational and transactional experience.
We're also planning to hire a chief Medical officer, a chief financial officer to round out the skill set of our senior team.
Occupier has a strong balance sheet, we had just over $42 million in cash on hand, and no debt at September 30th and received a $10 million milestone payment from Beatrice in October.
Based on our current projections, we estimate that this will give us runway into 2025.
We are continuing to look at all options to finance the next stage of development of a 33%.
And we were very active on the business development front as well we have ongoing dialogue with a number of large pharma companies for interested in a T X 33 30 for all the reasons I mentioned.
In conclusion I'm excited about the future of occupying my new role here.
We are dedicated to developing pharmaceutical products that are designed to improve standard of care in ophthalmology.
The planned advancement of a T X 33, 30 into Registrational trial marks an exciting new chapter of our strategy is rooted in rigorous scientific research and deep understanding of patient needs.
And we are building a team with the capabilities to execute and create value.
I look forward to meeting many of you in person as we continue to engage with the investment community over the coming weeks and months.
At this point I will open it up to questions operator.
Thank you and he would like to ask a question. Please press star one on your telephone keypad.
Information tone will indicate your line is in the question Kim You May Press Star two if he would like to remove your question from the queue and for participants using speaker equipment. It may be necessary to pick up your handset before pressing the star he is.
Our first question is from Kristen <unk> with Cantor Fitzgerald. Please proceed.
Hi, everyone. Thanks for taking my question Congrats on your appointment.
Yeah.
Now well.
Question I had was on API.
Zero.
Because we have a lot of examples in the ophthalmology.
We're in some patients.
<unk> are a lot more reluctant to get an injection.
The benefit right away and in some situations.
Dry AMD, we're saying that that's not necessarily the case so.
Maybe you could talk a little bit more about your market research, there and particularly how much the injection burden.
The doctor for patients not.
And also open the queue.
We're out there.
Profile remains robust.
Hi, so thanks for the question, it's a great question and as as you correctly pointed out you know that the.
For people with advanced non proliferative diabetic retinopathy there is.
Eylea or lucentis or others that are that may be used right as interim vitriol injections. However, the uptake has not been great. Because these patients are asymptomatic goes back to the analogy I gave about treating high blood pressure you know people, who typically don't know they have it until they bought.
Until they go to their doctor and get treated and that's much better than waiting until you get until you have one of the side effects of it right like a heart attack or stroke.
We think that our oral will be well tolerated for this and <unk>.
And I think that the reason for that is because of.
Okay.
Because of the stage of these patients in life right. So in dry AMD and in geographic atrophy in particular, where we've seen good uptake in what is.
And what is a disease, where you don't see an immediate sort of dramatic impact like you do in wet AMD or in diabetic macular edema.
These patients are older. They typically they do they do at baseline have geographic atrophy. So you do have areas, where their vision is blurred out.
And so they.
And so they understand because they have started to have the side effects of the progressive vision loss. There those patients are honestly pretty terrifying right. They are patient set.
That have already started to lose vision and they don't want it to continue right. They get these little spots are blurred and in that disease. What happens is they start to blur area in the center vision gradually get bigger until it's the entire area and so they actually see something in diabetic retinopathy, you don't see anything.
Those patients are walking around with typically very good vision. They don't realize they really have the disease.
Until they're told they have it now.
The reason that they don't.
The Y and oral is appropriate here and not an interventional injection like they do for.
Geographic atrophy or for wet AMD or for me or.
Or for P. D R is because.
Yeah.
When you are asymptomatic is a way bigger issue to convince someone to let you poke a needle in your eye every one to two months for the rest of their life. So like I said in their stage of life. Typically these are working age people like there typically twenties thirties forties years old they.
They have families. They have jobs and it's and it's really a big ask for someone who's a Cincinnati if it goes to the eye Doctor every one to two months to get a needle poked and there is and so taking a pill every day is is.
Is very acceptable for this patient population and typically they are on multiple therapies for the other potential complications of diabetes and so our market research is showing that that this this should be well received by the community and then and this is the correct indication for <unk>.
Laurel.
One I would point you to a couple of a couple of things for this number one is look at the uptake of a rats vitamins right. So a reds vitamins are used for people who have.
Intermediate dry AMD. These are patients who are asymptomatic as well and this is an oral tablet.
That's given that's given to these patients and it and it is it has it is the standard of care in all patients with intermediate dry AMD get put on a rat's right and it is universally used for these patients well tolerated and nobody even questions and so I can't imagine that in the future.
It's gonna be whether it's a P X or or or something else, we're going to have something similar for diabetic retinopathy, where we can treat it that with an oral that is generally accepted by the patient community. The second thing I'd point you to is we were at the ophthalmology innovation a source meeting the OIS meeting.
This past weekend.
In San Diego and they held their first.
Section on oral therapies in ophthalmology, and they had a number of companies that presented.
And in all and I can tell you and it's it's available you can you can you can see the summit knocking them through their website.
There was a lot of excitement from the community about different.
Oral therapies for D. R in particular and in other indications in ophthalmology for exactly the reasons that we mentioned so I hope that answered. Your question. Thank you. It's a really good question.
Yeah.
Uh huh.
About the commercial opportunity in that comment.
No.
Yeah.
Dan.
Wondering about that.
Thanks Darren.
And then there's no problem.
While that you think is most likely.
Therapy, initially and how you might look after that.
Yeah. It's a good question so I'm the way I'm envisioning this happening.
So all diabetics.
You know as part of its part of the the HHS and CMS initiatives for quality in health care and primary care is is that all diabetics should be are recommended to get a yearly right. It's part of their its just like you check the kidneys and stuff like that too.
So these patients are getting eye exams, and so I think that.
It's pretty straightforward at an eye exam to.
It's a diagnose mild moderate or severe M. P D R.
And so I I envision that these patients are gonna be identified.
And I think that it will become sort of the standard of care that when a patient has.
Mild moderate or severe M. P. D are they are.
Preventative heat treat it and you know once once we have good products out there. So so I think that I think that it's it's up in the air whether or not it will be prescribed by the ophthalmologists optometrists to primary care doctors, the endocrinologist or somewhere all of the above.
But but I do think that.
I do think that the market uptake will be.
It will be significant and and really one of the important aspects about an oral therapy for this is that.
Is that truly you are treating the EIS and that is that is the indication where after but you know is it possible that it might help with that.
Diabetic mediated diseases elsewhere in the body at the same time. So is is there a potential for for a systemic benefit as well and we don't know that yet right. We don't have that in our program, but I think that that's an advantage of having an oral over a over over an <unk> injection or topical.
And then the other thing I would I would stress about the commercial uptake is really the tolerability and safety profile, that's going to be super important and so far harvest has been favorable.
I think part of the reason that's favorable is because as you guys know the rough one.
Hum.
Modulation that that a T X does actually reduces.
In veg F levels back to a physiologic level it doesn't completely deplete them like you would get with and I leave or any Boston or the others Lucentis the others.
And that's why I think that that's part of the reason why.
We do have a favorable safety and Tolerability profile is because we arent completely decimating the systemic.
<unk> levels were actually reducing them physiologic club. So it's a there's a real mechanistic advantage to the a T X.
Modulation of angiogenesis that that's quite elegant and and quite.
Favorable for patients.
Thanks, a lot if I could squeeze in just one last question.
The space Theres, obviously been a lot of excitement around G. L. P runs in obesity and diabetes. So I'm wondering as you have these conversations.
Conversations with pharma and more companies are becoming.
Do you think is more appropriate to target a partner potentially if you pursue that route that has expertise in diabetes or ophthalmology or perhaps you know you're open to it.
At this time, thank you again.
Boy, you're hitting on a key strategic point that we are very thoroughly evaluating right now.
And I think that's incredibly insightful right because diabetes is a metabolic disease and we are treating.
Systemic manifestation, we are trading.
The eye, but theyre also systemic manifestation ramifications of rough one in the body and so where we are very closely looking at that right. Now we we don't we don't know yet right. So I think that's the answer so we're in those discussions we're having those discussions and hopefully we'll be able to guide you guys in the future.
On our.
On our appropriateness as you.
You know a metabolic treatment.
So that's it.
It's a it's a very.
Exciting time in metabolic disease, right, now and and great things are happening for patients. So it's something we're evaluating very closely.
Great. Thanks again.
The next question.
He is from John Newman with Canaccord Genuity. Please proceed.
Hi, there good morning, Thanks for hosting this call and thanks for taking my question just had a couple mainly around the.
Potential path forward in design for the Phase III study for apex 3330, what I'm curious about is.
I know that the.
The design is still being debated.
In plan, but what do you expect that you would be looking at the same endpoint at 24 weeks as you did.
In the phase two and then I'm also curious.
What are some of the key aspects that you're looking to clarify are finalized in the S. P. A M. Just wondering for example would you be able to look at <unk>, we're seeing on a monocular.
Basis in addition to buying ocular thanks.
John Great question. Thank you for that I'll answer I'll answer the first part and then I'll, let Ron will take the second part so I'll answer the part around the.
Around the scales and how in the in the endpoint that we are proposing for the phase III and that has been agreed with the FTE in the phase two meeting and then I'll, let rune will talk about the spa itself and and some of the aspects of that and we're working through so for my for for the aspect of of the endpoints that you.
And so.
We will be looking at a 48 week end point, so we're going to be looking at a one year endpoint, which is where which is the appropriate thing to do in diabetic eye disease, because the event rates will be at an appropriate size for our clinical trial at that point right.
And what we've agreed upon with the FDA and this is quite it's quite interesting and I mentioned the OIS summit. This weekend and it really was very very interesting to hear the panelists talked there about about how these endpoints are evolving in diabetic retinopathy, because there is a move towards.
Looking at patients who are truly worsening. So if you look at some of the prior studies.
We're done with the interventional injections. They came at the approach of improving very advanced disease right. So they they they were looking at two step improvement on a monocular AR D. R. S S.
We're coming at it from the other end right, where we're trying to prevent progression in patients that are on that.
Still the asymptomatic portion of their disease and haven't haven't become.
You Havent havent gotten to two it to that level, yet and and when you do that what you care about is not whether or not you improve what they have but whether or not to prevent them from moving onto a three step worsening.
Which is which gives you.
You know the logical step from that is if there were seeing about three steps then theyre going to have an event like P. D. R. And then they're gonna have vision loss and actually what we saw in the phase two data when we looked at buying ocular three step worsening was exactly that we were looking at the trends towards three step.
Worsening being less than the a P. Exxon them you know.
You know 14% in the in the the placebo arm, 4% in the eight T XR than we were looking at.
The PDR rates being lower trending lower in the a P X arm and then we were looking at vision loss trending lower in the AP excellent. So it makes a real logical kind of.
Walk towards something that patients really care about right, which is am I going to lose vision.
So I think that's a great endpoint because it is.
The.
Does it truly does.
<unk> patients are at risk for the clinically meaningful endpoint, which is vision loss.
It's it's a it's a very objective endpoint that's done on photographs and.
And it's and and the F D. A is.
Is advantageous towards at the end of Phase two meeting. So this is like this is a great step forward for ophthalmology in general too.
To really look at diabetic retinopathy in this in this manner and so I think I think this is a wonderful thing.
You can look at it in the monocular way, but when you're treating systemically. It makes it makes a lot more sense to look at both eyes, and that's and that's what we're going to focus in on is both eyes, but to answer the last part of your question, which was about monocular and so I think what we need to do is is it.
As you know how you know the phase two study wasn't powered for.
Three step worsening.
Or for PDR or for vision loss. So in the phase III when we powered for that if we can replicate those I think we have a very very meaningful story for not just the FDA even also for patients.
<unk> I'll turn it over to you to talk about the spot a little bit.
Yeah sure. Thanks, John.
I just wanted to remind that we had already agreed on the primary endpoint for our pivotal phase III trials, which is a three step worsening on the vine ocular D O S S scale.
We will need the standard two pivotal placebo controlled phase III trials.
With a one year efficacy endpoint the spot is really to solidify the exact language in the protocol and agree on the statistical analysis plan.
We're collaborating with the FDA on how to handle certain aspects of the statistical analysis plan.
In particular, the hierarchy of the secondary endpoints the statistical powering a exact number of patients with the ultimate goal of having the broadest in the best label possible. So that's really the purpose of the spa.
Yeah.
Okay.
Okay, great. Thank you.
Yeah. Thank you John.
As a reminder, this star one on your telephone keypad, if he would like to ask a question we will pause for a brief moment for any final questions.
There are no further questions at this time.
Like to turn the conference back over to management for closing comments.
So I would like to thank everybody for joining us today, and we look forward to interacting with you guys in the future and being able to provide.
More updates as we progress pretty rapidly through through the development program here.
Thank you. This will conclude today's conference you may disconnect. Your lines at this time and thank you for your participation.
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