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Annual and Special Meeting of the Shareholders of Zenith Capital Corp. and Corporate Update Presentation

 

December 22, 2020 at 2:00 PM MT

 

 

 

Slide 1 – Title Slide

 

Moderator: Thank you for standing by. This is the conference operator. Welcome to the corporate update presentation of Zenith Capital Corp. I would now like to turn the conference over to Donald McCaffrey, President, CEO, and Chairman of the Board of Zenith Capital Corp. Please go ahead Mr. McCaffrey.

 

 

 

Donald McCaffrey:  Alright. Thank you for attending. I think you’re going to be happy that you’re here for this part. I’d like to acknowledge right at the beginning that there will be forward looking statements in this presentation, and some matters may change. We’ll keep you updated if that’s the case.

 

 

 

Slide 2 – Company Profile & Highlights

 

   “Registration enabling studies in process for 2021”

 

Alright, on slide two, what I like to call the cocktail approach to multiple synergistic targets. And the cocktail approach was originally referred to in the HIV or AIDs world when they finally made traction in science against that terrible virus when they started administering two, three, four, and even more different drugs at the same time, because it’s so complex. It takes a lot of shots at goal to make an impact. That’s what we’re finding here.

 

The different eggs you’re seeing listed there are like PARP inhibitors, androgen receptor antagonists, immune checkpoint s [Mabs – monoclonal antibodies], MEK inhibitors [mitogen-activated protein kinase inhibitors]. These are some of the hottest targets in cancer fighting right now. And our drug works with all of them.

 

We have some of the same properties, but I think we would be not near as successful if we were trying to do it as a stand-alone and try to prove hey we’re as good as any one of these. There’s a lot of activity out there. But when you mix them with ours and theirs works a lot better, that’s when you have a lot of potential.

 

 

 

Slide 3 - Company Profile & Highlights (Identical Slide except for the phrase

 

   “Registration enabling studies in process for 2021”)

 

So we can work with existing drugs, rather than trying to replace existing drugs. We can make existing drugs work longer and harder. Therefore with pharmaceutical companies, that evergreens their cash flow. So that’s a really important concept to think about when thinking of Zenith Epigenetics. We can work with many different companies, and as you’re going to see, we are.

 

We have already started registration-enabling studies for 2021. And in this level of cancer development Phase II B programs can be registered; it happens quite regularly. So we’re moving on a fast-track approach here. And [we’re] quite excited about the potential of where this is headed.

 

 

 

Slide 4 - Company Profile & Highlights (Identical Slide except for the phrase

 

                “ZEN 3694 + talazoropib (not exclusive PARB) in TNC (biomarker)”)

 

We have programs that are involved with Pfizer with their PARP inhibitor. That’s in triple negative breast cancer. [talazoparib- (not excusive PARP) in TNBC (biomarker)].

 

 

 

Slide 5 – Company Profile & Highlights (Identical Slide, except for the addition of

 

                “Zen 3694 +enzalutamide in mCRPC patients with poor response to abiraterone”

 

 

 

We’ve advanced forward in the enzalutamide program.

 

[in mCRPC patients with poor response to abiraterone]

 

[mCRPC is metastatic castration resistant prostate cancer].

 

 

 

Slide 6 – Company Profile & Highlights (Identical Slide, except for the addition of

 

                “National Cancer Institute clinical collaboration for developing multiple BETi combination therapies in molecularly defined cancers.”

 

And most importantly, we have now become a partnership with the National Cancer Institute of the United States. This is a clinical collaboration for developing multiple BET inhibitor [combination] therapies in molecular defined cancers.

 

So they have a program called CREDA [Cooperative Research and Development Agreement]. And what CREDA is, what they’re doing is showing... what they’re trying to find is synergistic drugs. So they are focused on these combinations and they are sponsoring and paying for these trials.

 

 

 

Slide 7 – Company Profile & Highlights (Identical Slide, except for the addition of

 

                “Strong partnerships with multinational pharmaceutical companies”

 

So we find ourselves in a very unique spot right now as I’ll show you on the next slide.

 

 

 

Slide 8 – Zenith’s Clinical Pipeline (no assigned rights except China)

 

As you can see, this has advanced considerably during 2020. Even with COVID around, we have been extremely busy at Zenith, and we’ve advanced our prostate program – it’s moving into a phase 2/3 program in China with our partner Newsoara who are paying 100% for that trial.

 

We are still working forward and advancing – and I’ve got some great detail on it for you – in our breast cancer collaboration with Pfizer. Pfizer pays 50% of that.

 

We have now launched, and will dose our first patient in Q1, a program headed by UCSF in San Francisco. It involves Merck’s top cancer drug [Keytruda] and Pfizer’s enzalutamide. So this is a three-way combination, and this is being paid for by the other parties, not us.

 

The immuno-oncology combinations that we have launched and announced, the first of them – only the first one, there are many more to come – the first one has been announced with Bristol Myers Squibb. This is part of that CREDA program. And that’s in ovarian cancer, triple negative breast cancer, and melanoma.

 

We have other PARP inhibitors, MEK inhibitors, CDK4s [CDK4/6i’s – cyclin-dependent kinase inhibitors], and chemo combinations that are in programs such as HR positive breast cancer, ovarian cancer, colorectal cancer, prostate cancer and others. And that involves Cleveland Clinic, MD Anderson (I love their logo where they scratch the word cancer out, we’re all working towards that), and Dana Farber – for those who don’t know that’s actually at Harvard. So some great names. Dare to say under our CREDA program we should have four or five more programs added on here in the next six months. It’s going exceptionally well.

 

These programs as I’ve stated are paid for by the sponsors. And our commitment is a small annual fee to the CREDA, plus supplying the drug. So a beautiful program for a small company like us. And it’s showing results already. That’s the exciting part. And that’s why the National Cancer Institute is doing it. They want to see the results. They want to see how these work together. And currently on the registry we’re their only BET inhibitor. So this is really good news for us. And I think that’s the case because – they had them before but the toxicity levels of the competing programs are far higher than ZEN 3694. We’ve done a very good job in the tox profile of this program.

 

 

 

Slide 9– Published Prostate Trial Data

 

So on slide four

 

 [which is what it would be if slide 2 had not been divided into slides 2-7 but it is marked as slide 9 even though he said 4],

 

it’s an old slide but just to remind you. Our prostate program had great success. And it is now moving forward; it has approval to go into what will start as a Phase II and move into a Phase III program in China and in the United States. China will launch first. And this is being paid for by our partners in China Newsoara. A fantastic company; we’ve been working with them quite well and look forward to launching this in humans in this next program.

 

 

 

Slide 10 – Pfizer & Zenith Combination Therapy Study: Triple Negative Breast Cancer (TNBC) Results

 

OK, this particular slide– I believe it’s number 5 –

 

[Which it would be if he had not divided slide 2 into slides 2-7, but it is marked as slide 10 even though he said 5].

 

This was compiled by Pfizer, and it’s part of a compilation that they presented at the Breast Cancer conference a couple weeks ago in San Antonio, Texas.

 

[Study number: NCT03901469. Study start date June 2019. Estimated study end date January 2022. Summary dated December 2020. Abstract Title: A phase 1b/2 study of the BET inhibitor EN003694 in combination with talazoparib for treatment of patients with TNBC without gBRCA1/2 mutations.]

 

And they’re showing some of the earlier work. We have a lot more data than this now and I’ll share some of that in a couple slides. This is based on some of the earlier work in the first phase of our breast cancer program with them in triple negative breast cancer.

 

 

 

Slide 11 - Study Design

 

So this took place when we had about fifteen people in the study.

 

The final numbers that have been studied to date are thirty, and we have twenty more going in. I’ll talk about that as well.

 

This just basically says who’s taking part in the study. And what it’s showing is that there are really a couple different groups, and that’s helped us.

 

So patients who either had HER2- develop into triple negative breast cancer, patients who at enrollment had triple negative breast cancer, or some that had had other hormone therapies that they were not suited for other hormone therapies.

 

[Criteria on slide were:

 

·         Were HER2- and did not have inherited faulty BRCA1/2 genes

 

·         Were not suited for hormone therapy or HER2- directed therapy

 

·         Had received 1 or more types of chemotherapy for metastatic breast cancer]

 

 

 

Slide 12 – Drug and Dosing Combinations

 

On slide number 7 [which it would be if Slide 2 had not been broken up into slides 2-7],

 

we broke them down into three different groups or cohorts and tried different doses in this so that we could get it right, especially for going forward for the next step, which is the one that’s already ongoing.

 

So here we tried a high dose of Talazoparib (1 mg) and then Zen 3694 at 48 mg;

 

 then we lowered the Talazoparib (0.75 mg) and kept ours the same (48 mg);

 

then we went the other way we lowered ours. (Talazoparib at 1 mg and Zen 3694 at 36 mg).

 

 

 

Slide 13 – Trial Results

 

So what it showed us on Slide 8 [which it would be if he had not divided slide 2 into slides 2-7], was in our go-forward mode our best choice was the low dose of Talazoparib and the high dose of Zen 3694. Not too surprising. These PARP inhibitors like Tala, they’re known for toxicity. These are cancer drugs; they’re supposed to be toxic [sic]. And they don’t mix well with other drugs. So the fact that they mix well with ZEN 3694 is a real real positive for us.

 

What we also learned in this trial was we reduce levels of important genes [Slide mentions CCR1, IL1RN, and IL8]. That showed activity against cancer. So this is really important. Some of these IL-8 genes, and the CCR-1 – we were able to confirm in diagnostic studies that those were down. And the doctors involved in this particular trial are some of the top breast cancer doctors in the United States –Including Memorial Sloan Kettering in New York and UCSF in San Francisco. So the doctors reported that 6 out of 10 people, their tumors shrank or did not grow. That’s very good news and I’ll show you further results in a minute.

 

 

 

Slide 14 – Trial Conclusions and Results

 

The main conclusions - It was a small study with metastatic triple negative breast cancer. That means that’s cancer that’s spreading to other parts of the body. Even if it spreads to the brain or the bones it’s still referred to as breast cancer, because that’s where it originated and it’s the origin of the tumors.

 

We had a lot of positive results in playing with the doses and figuring out what’s going to cause thrombocytopenia, which is thinning of the blood platelets. PARP inhibitors do that generally. Our drug does it if you’re at really high doses, so we had to be careful mixing the two and taking care of the patient first. But we got very solid positive results on that.

 

So most oncologists deal with thrombocytopenia daily. It’s such a common thing in cancer treatment. It’s the problem with chemotherapy etcetera, the lower blood platelets. If your blood platelets are normal they should be somewhere between 200,000 and 400,000 [per Google, 150,000-450,000], and chemo drugs can drop them down below 10,000. So you’ve got to be very careful, and monitor. So it became simple, some of the solutions were simply lower the dose or give a short holiday of not taking the drug, but in most cases they were able to dose right through, so that’s a positive.

 

[Slide reads:

 

·         This small study in people with metastatic TNBC without inherited faulty BRCA genes provided early evidence that combining talazoparib with ZEN003694may stop tumors from growing. More people will take part in the second part of this ongoing study.

 

·         The amount of talazoparib plus ZEN003694 in the blood increased as the dose of each study drug was increased.

 

·         With the combination of drugs, the most common side effect was low levels of platelets in the blood (called thrombocytopenia).

 

·         Reducing the dose of talazoparib plus ZEN)) 3694 or temporarily stopping treatment helped manage this side effect. These dose reductions or temporary stops in treatment did not seem to affect the activity of these drugs against tumors.

 

 

 

Slide 15 – TNBC Program Highlights Significant Breakthrough in PARP Combo

 

Now in the triple negative breast cancer program, we have significant breakthroughs here on slide 10. [This is slide 15].

 

This is exciting data, and when you show this to oncologists they get excited. The reason being is that this is a particularly negative version of breast cancer. When it starts to metastasize it’s going fast.

 

And for us to see on the right hand side that we had so many patients with partial response decrease, and on the upside very few different.

 

So what we learned is the difference between some of these biomarkers in the study.

 

And one of the biomarkers is really quite interesting. It would be the dark blue one; I won’t reference it here today. But it’s very interesting because on the right hand side where most of the really positive ones were, we could all determine early who those are before we even dosed. 

 

So now we can go in and make this even more personalized medicine. So not going in and giving something to somebody who’s stretched out and been on three other types of chemo and other drugs already.

 

So this is really good news for patients, for doctors, and for us.

 

You can see that with this particular biomarker we showed an overall response rate (complete response + partial response), reduction of over 41%. That is good.

 

The clinical benefit ratio – and what this is is the ORR plus anybody that was stabilized. So instead of just showing regression, you’re also stabilizing in this one and that one went as high as 59% at four months, and 56% at six months.

 

Now the next slide should tell you something rather important.

 

 

 

Slide 16 - TNBC Program Highlights Significant Breakthrough in PARP Combo

 

   (On-line presentation shows same slide as above)

 

What do those numbers mean to you? They’re hard to judge for a lay person. It’s hard to judge for me until my staff tells me what’s going on.

 

But the overall response rate of a drug called Trodelvy was 35%. We’re at 41.

 

The clinical benefit rate at six months was 45%. We’re at 56.

 

And so we are very excited about that because Trodelvy was owned by Immunomedics.

 

And Gilead bought them a month ago for 21 billion dollars.

 

That company’s ahead of us, and I’m not saying we’re worth 21 billion dollars. We’re not even worth close to that. This company is actually going to market in early 2021.

 

What I’m trying to show is this is a small-molecule drug in combination with Tala is more effective and certainly cheaper than what can be done with a monoclonal antibody.

 

 The safety profile, we believe from what we’ve seen, ours is superior.

 

So we’re pretty excited with the potential of where this is going.

 

And for us, this leads into what are the next steps.

 

Well, we got this data in time. In time for moving this forward into what’s called the Simon 2 stage study. [See: https://blog.statsols.com/simons-two-stage-design]. So the first stage is done; the second stage will have twenty patients in it. We had hoped to enroll some of those this year. And you’re probably waiting for the other shoe to drop and expect me to say that because of COVID-19 we were unable to.

 

We hoped to have 4 or 5 of them enrolled this year of the 20. We’re already at 14.

 

It has gone extremely fast. This is a small oncology trial that is done mostly outside of the hospitals that are handling COVID patients, so COVID has not affected enrollment of this trial. People are enrolling in this study extremely fast, because the doctors know the results from the previous section. And we’re pretty excited to see that.

 

This trial won’t take that long. We’ll have this data in early Q2 of 2021.

 

So we are very excited with the progress that has been made on the clinical side here. And we have been in discussions also with Zenith with major pharmaceutical companies in detail as to where this is and where it’s going. And it’s exciting. Stay tuned on this one. It’s got some wheels going right now.

 

 

 

Slide 17 – 2020 Milestones Leading to Major Collaborations

 

As you can see really in this ”Milestones Leading to Major Collaborations” [slide], this is basically what we’ve done this year.

 

 As everybody pretty much knows, this company was spun out of Resverlogix in 2013. And at the time when we started in oncology, we were two years behind any other cancer program. We’re now about three or four years ahead of any other [cancer] program. It’s gone quite well.

 

The program is advancing. We’ve financed some of it with licensing China, much like what was done with Resverlogix. That partnership has been a pleasure to work with them. So we’ve received money from them throughout the year.

 

Pfizer has continued their collaboration. They had options to discontinue at the end of the Simon first stage, and continued on. They are, as I said earlier, funding 50% of this breast cancer portion trial. We have other breast cancers in other trials that are 100% from other pharmas as well.

 

 We got our CFDA China approval to run this trial and it’s starting up.

 

We’ve had discussions with the National Cancer Institute as I’ve mentioned already. I think I went into those in enough detail. We’ve launched the first CREDA and the first dosing of those patients in ovarian cancer will be in Q1.

 

Efficacy trials for our Pfizer collaboration are ongoing. And UCSF Merck and Pfizer drug are proceeding with first patient in Q1.

 

So we’re pretty excited. It’s been a really really good year at Zenith and the amount of attention that we’re getting from the majors and the cancer conferences and people who want to partner their drug, because they don’t have to change drugs, they don’t have to change horses so to speak. They can keep their existing programs, make them last longer and generate more money and have better results for their patients.

 

So on that note...

 

 

 

Slide 18 – Questions & Answers

 

I’m going to move to the questions and answers. And we had a few of those come in for Zenith. One second. OK this first one I love it.

 

Do shares of Zenith trade on the OTC gray market under the symbol ZENHCLF or any other public exchange?

 

We have an answer to this on our frequently answered [asked] question section. And it involves FINRA or the Financial Industry Regulatory Authority in the US and the symbol and link is there also. So in short the answer’s yes and no. We have not registered this company to trade on any exchange. However, people think of us as Resverlogix is public, you’re private. That’s not necessarily the case. We are a reporting issuer, meaning that we have over a certain amount of shareholders and we have a duty to the securities exchange groups to properly report, account etcetera. And we follow that. But as such we are issued a CUSIP number. And in the United States the agency or brokers or whoever wants can list that CUSIP number for trading if they want. We want to make it crystal clear that that is not us listing that. If you are trading on that, I don’t recommend it, I don’t discourage it, it’s nothing to do with me. So going forward if anything changes in that realm as to whether we list somewhere, that’s fine. If you were to buy stock from me from treasury, you wouldn’t get it anywhere near as well-priced as the trades on here, so we don’t recommend this one in either direction. So that’s all I can say on that.

 

 

 

Does the company have any plans to list on a public exchange? If so the timing, if not what are the other exit options?

 

So at this time the company has no clear near-term plans to list its shares on a public exchange. To do so would have basically required the kind of data and information that we are only just getting. And as we area in multiple discussions right now it seems unnecessary at this point, but we will continue to review it, and first try to benefit from any significant partnerships and collaborations that involve multi-national pharmaceutical companies. We believe that we’re in a strong position to unlock some significant value for shareholders in the near future. Above and beyond partnering opportunities being pursued, Zenith is also pursuing multiple equity financing scenarios with existing shareholders and some new shareholders. So we do have lots of options here. As you can imagine, running Zenith under the scenario with having partners in current cases mostly paying for the entire clinical trial development side and in other cases at least half, that puts us in a very manageable position.

 

 

 

So another question here is: Can you review the relationship between Resverlogix and Zenith Capital Corporation? Can the success or failure of one affect the other?

 

So as most of you are aware, the vast majority of Zenith shareholders received their shares as a result of the spin-out of Resverlogix Corp. in June of 2013. Some others have bought since then. We appreciate your support and feel you’ve made a good investment. So at the time of the spin-out, Resverlogix shareholders received one share of Zenith Epigenetics Corp. for every share of Resverlogix held with no additional cash outlay. Zenith Epigenetics subsequently changed its name to Zenith Capital Corporation. Since then, Zenith and Resverlogix have been separately owned entities. The two companies share or have several directors in common and thus are considered related parties. Resverlogix provides management services to Zenith to achieve greater utilization of resources. This arrangement has worked out efficiently for both entities. In addition, Zenith provides some research services to Resverlogix, enabling Resverlogix to obtain access to specified [specialized?] research knowledge and services on a more cost-effective basis. Both companies are leaders in their respective areas, utilizing novel epigenetic platforms and have been instrumental in transforming bromodomain biology into impactful therapeutics for the benefit of patients with cancer and chronic diseases. In our view, the continued success of one company certainly has a positive impact on the other.

So thank you very much again for attending the presentation. I’d like to wish everyone a happy holiday season, and please stay safe out there. Take care. Thank you.