Pharmala Biotech Holdings Inc. (CSE:MDMA)
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May 1, 2026, 3:59 PM EST
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Earnings Call: Q1 2025

Feb 6, 2025

Nicholas Kadysh
CEO, PharmAla Biotech

Today is our new CFO, who you probably haven't had a chance to hear from, at least not live like this yet. This is Will Avery, everyone. Will retired from MNP LLP in 2023, where he was a partner, spending the majority of his time over a 20-year career there servicing public companies like ourselves. Will's based in Toronto, where he lives with his wife and two young kids. He joined us back in September, Will? August, September? Something like that?

Will Avery
CFO, PharmAla Biotech

Yeah, September. Officially in October.

Nicholas Kadysh
CEO, PharmAla Biotech

Officially in September. Yeah, yeah, yeah. Will's been helping us with all kinds of stuff and really professionalizing the organization. Glad to have the investors have a chance to speak to him and hear from him today.

Will Avery
CFO, PharmAla Biotech

Yeah, happy to be here too. Thank you, Nick, for that intro. I'm absolutely so happy to be a part of such an awesome team here, and I look forward to what we're going to be able to do in the years to come. Before we get underway here, I would like to take this opportunity to refer to the cautionary wording about forward-looking statements, as well as the risk factors included in our MDMA as filed on SEDAR Plus on January 29, 2025. Those statements about cautionary wording and risk factors apply to the information discussed in this webinar as of the date of this webinar being February 6, 2025. However, this webinar is intended to be a discussion of the interim results for the period ended November 30, 2024, and is not intended to be an update of the information therein to the present date.

With that, I'd like to start with an overview of the key aspects of our recent financial results. During fiscal 2024, the company realized revenue of over CAD 1 million, representing growth of approximately 95% year-over-year. This was led by growth in MDMA product sales of CAD 723,000, or a 73% increase year-over-year. In fiscal 2024, the company also increased customer deposits to CAD 208,000. In Q1, we've continued this growth, which has resulted in a CAD 70,000 increase, bringing the total customer deposits to CAD 283,000. Just to give a little background on that, generally, we require deposits that account for up to 50% of the total contract value.

While not universal to all of our contracts, many of these deposits are non-refundable, or refundable only in the event that customers' failure to secure a clinical trial permit is based on our underlying chemistry, manufacturing, and control information, which we provide to these customers. The related customer deposits can be recognized along with the remaining revenue when the underlying product is delivered to the customer. Based on our experience, it is uncommon for clinical trials not to move forward. However, in fiscal 2024, we did have one such instance, and as a result, the non-refundable deposit was taken into revenue. While we would have loved to see the growth in deposits turned into revenues in Q1, our sales cycle is such that many of these customers require the issuance of their clinical trial and/or import permits from the relevant regulatory bodies before we can ship the related material.

Adding to that, on October 21, 2024, we terminated the supply agreement with CCrest Labs and initiated a program to secure new distributors in both the U.S. and Canadian markets. We have successfully partnered with Rane Pharmaceuticals, who are already a manufacturer and research partner of the company, and we've recommenced distribution subsequent to November 30. In the U.S., while we continue to seek a permanent distribution partner, we are currently moving forward on individual exports for U.S. clinical trials and have applied for the necessary Health Canada export permits to enable us to do so. Due to the highly regulated nature of our operations, all of these initiatives have taken time to accomplish, and as a result, during Q1, we didn't fulfill any shipments of MDMA product to patients under the SAP or to clinical trial customers, and our revenue was limited to the Cortexa license fees.

As mentioned, having partnered with Rain, we've recommenced distribution, and upon securing the necessary permits, we expect to ship the related products and recognize the revenue in future quarters. Another item I'd like to highlight from Q1 relates to our cost profile. There were some newfound efficiencies that allowed total expenditures, excluding stock-based compensation, depreciation, and amortization, and the loss on debt settlement, to remain relatively consistent quarter after quarter, despite bringing strategic team members on board. While these team members carried incremental costs resulting in an overall increase in expenses, we believe we are stronger and better set up for the future with their addition. Further, some of those incremental costs were offset by cost reductions elsewhere, primarily in office and general expenses. The final item I'd like to highlight for you all today pertains to our financing position.

During the period ended November 30, 2024, and subsequent, we've secured funding reflective of our team's commitment and belief in the future of the company. Firstly, we entered into a share for debt settlement with our legal counsel, taking CAD 100,000 accounts payable off the books without using any cash. Secondly, our director group stepped up and exercised some of their outstanding options, resulting in a further CAD 42,500 on top of the CAD 70,000 received in fiscal 2024 from the CEO. We believe that this shows a commitment of management and directors to the company's future. Lastly, and most importantly, on December 13, 2024, we secured funding from the sale of units consisting of one common share and a half warrant, which is exercisable at CAD 0.27 for three years, for gross proceeds of just over CAD 1.5 million.

We are pleased to announce that Matthew Azrieli participated as a lead investor in this private placement and, as announced today, has subsequently agreed to become an advisor to the company. These inflows have strengthened our cash position for the future, and combined with the conversion of our customer deposits into revenue and our partnership with Rain, we're well positioned for our future growth. Nick, I'll turn it back to you.

Nicholas Kadysh
CEO, PharmAla Biotech

Yeah. Look, guys, if I can distill down some of the stuff that Will talked about, number one, I think, look, long-time investors and shareholders of the company will know to look for the line item of customer deposits in our financial statements. New investors and shareholders may not know it, but it is sort of critical to the business, right? We've never had a situation where our documentation is the cause for someone not to get their clinical trial approved. That's really the triggering factor for a refund. If we continue to do our jobs properly, of course, those deposits continue to fuel the growth of the company. We utilize that cash for ongoing operations, and it does get converted into revenue for accounting purposes when we actually ship the goods. We don't control entirely when those goods are shipped.

It depends on a range of factors: regulatory operations, just physical operations, getting the goods to their destination. We are always looking to improve our operational efficiency. We will be talking in some of the question and answer period about what we are going to do around the United States, about positioning inventory. Certainly, lots of questions have come up in the last little while around tariffs and what those do to us. We are always looking for better ways to be more efficient and get our goods closer to customer, which is part of the reason why we started Cortex Labs and why we began to do manufacturing in Australia for the Australian customer, right? The closer we can get to that end user, I think the better off the company is in the long run.

Frankly, I think it also improves our cost base, both cost of goods and, of course, just our operational costs. Canada is not a low-cost jurisdiction, unfortunately. Despite all being from Canada and being strong boosters of Canada, it is not always the best place to do your manufacturing, and certainly shipping everything from Canada is not always the best sort of operational decision. With that, maybe I'll ask Conway to start reading through some of the questions that we received in advance of the webinar. We'll try to field all of these questions. Now, there is at least one person I know who may have some questions. Conway, can you just text Robert and let him know that he's welcome to ask any questions that he has? Robert is actually a professional analyst, so I'm not playing favorites here. It's a professional courtesy.

If he has any questions for us, he is more than welcome to ask them. Other than that, for the investors, we have received your questions in advance, and we'll feed them one at a time, okay?

Will Avery
CFO, PharmAla Biotech

All right. I'll dive right in. When will we be moving forward with our Phase 2 trials?

Nicholas Kadysh
CEO, PharmAla Biotech

Will, you want to go that one?

Will Avery
CFO, PharmAla Biotech

Okay. Yeah, I can take that one. Look, as you know, clinical trials, they're expensive. We went into last year with the stated goal of finding a non-dilutive partner to cover at least part of those costs. That process is still ongoing, and although we have had some progress, we do not have anything specific to report at this time. There have also been some changes reported by the Australian Tax Office that have delayed our progress. We hope that we will be able to make an announcement by the end of this quarter. I want to just make it clear for everyone that that timeline may shift. We are doing our best to keep moving all of this forward and find that funding partner.

Nicholas Kadysh
CEO, PharmAla Biotech

Yeah, I will just add, it is really about finding efficient ways to fund the trial at this point, the protocol. I think, again, this is, I think, all well known, but the protocol is done, our trial partner is sort of in place. It's really a question of making sure that we finance this in an efficient way, both from a tax perspective and from just not just selling shares, but also maybe finding a non-dilutive partner who can help us with it.

Will Avery
CFO, PharmAla Biotech

Thanks. With the increasing momentum around MDMA in the industry, how does PharmAla plan to leverage this trend to its advantage while also balancing its other projects in its pipeline?

Nicholas Kadysh
CEO, PharmAla Biotech

Okay. Conway, I see Robert does have his hand up, so maybe if you can text with him and just find out what his question is. Okay. Number one, look, I agree. I will say we are seeing very significant increased sales as a result of the acceleration of government funding for MDMA research, especially in the U.S. We are also seeing increased clinical trials in Canada, although future clinical trial demand for MDMA from Australia has slowed down a bit. I think this is somewhat logical because now there is an actual access pathway in Australia, right? At this time, we do see progress made in our sales pipeline as synergistic with the rest of our business. If we have a profitable year, we can reinvest in R&D, we can develop new drugs, et cetera. We are also clearly monetizing our MDMA development in another way.

As you would have seen a little while ago, we announced our first drug-for-data deal for LaNeo MDMA, and that can help us a lot. I mean, it can help us with reimbursement, it can help us with product registration in certain markets. I would expect that we are going to do more deals like that in the future. Of course, the primary responsibility for the company is just to drive sales and drive revenue.

Will Avery
CFO, PharmAla Biotech

Should we give Robert a chance to speak right now as he has his hand up?

Nicholas Kadysh
CEO, PharmAla Biotech

Sure. I think he just asked a question. Go ahead.

Will Avery
CFO, PharmAla Biotech

Robert, whenever you're ready.

Hear me?

Yes.

Nicholas Kadysh
CEO, PharmAla Biotech

Yeah, yeah, we can. Yeah.

Yeah, I just wanted to know, you announced several contracts, I think around five, but since over the last three or four months. Are you able to disclose how much those contracts in aggregate are worth to you in terms of revenue going forward?

I think what we can do is, based on our current financials, so these would include all of the deposits made to date. I think we were at about, Will, correct me if I'm wrong, CAD 280,000 in deposits?

Will Avery
CFO, PharmAla Biotech

Correct. Yes, CAD 280,000 in customer deposits.

Nicholas Kadysh
CEO, PharmAla Biotech

Okay. That would translate to a 50% deposit. That would translate to just under CAD 600,000 in potential revenue out of those contracts. Now, I will say that does not include all of the contracts that we have announced because at the time when we closed the financials in November, we had not received the deposits for all of those customers. It is more than CAD 600,000, assuming all of those go through, of course. That is what it would have been at the time of the last financials, and I should not front-run the financials.

Do you actually, when you deliver them, do you deliver them in batches, in separate batches at different times to the particular client, or is it one batch to each client?

Yeah. Okay. Sometimes when our client—look, we're in the customer service business. If our clients really want multiple shipments, we will deliver multiple shipments, and we'll recognize the revenue partially rather than all at the same time. Due to the regulatory environment that we live in, we don't love to do that just because it's import permits all over again, and it's painful. It also costs our customers quite a bit of money. I mean, a controlled substance shipment just from Canada to the U.S. can be like $3,000.

That said, if the customer wants to pay it and they really do not want to hold the material, or they are worried that if they have a long-term trial and they want fresh batches of drug product along the way, yeah, look, I mean, the answer is yes, we will do that sometimes, but it is not our preference.

Right. Just a couple of more questions. It seems like Lykos is preparing to, and it's been in discussion with the FDA, preparing for a third study of its Phase 3 MDMA-assisted therapy. Are you actually, since they've cut out their production capacity, are you going to be supplying them?

We have no contract with Lykos at this time. That said, we do have a very warm relationship. It's been reported in the press that they've sent a number of clinical trials our way. I can confirm that. That is accurate. Look, if they need material, if they need support, we are happy to provide it, and we'll just stay close to them and be of service wherever we can.

Yeah. My final question is basically, can you give us a latest on your own drug development projects?

Yeah, absolutely. We talked a little bit about the Phase 2 trial for ALA02 already. That's where that is. In a similar fashion for APA, which is our sort of tier two molecule, we're looking at ways to do the preclinical for that molecule, and it does require preclinical because it is a net new molecule. For that one, we're trying to find, again, non-dilutive partners who could help us finance that. Preclinical, there's sort of two elements to it, right? There's the chemistry, manufacturing, and control, the manufacturer of the new molecule, and there's the actual rodent testing. Most of the rodent testing that we do at the University of Arkansas for Medical Sciences at Bill Fanteg rossi's lab, that's non-GLP rodent testing. It's what we call proof of concept. It is not acceptable for the kind of toxicological dossier that we would need to develop.

Again, we're looking for a non-dilutive partner. We think we found one. We think we're close, but until the deal is done, nothing is there. Again, hope in the next three months to be able to announce both the non-dilutive funding for the ALA trial and some non-dilutive funding for the development of APA through preclinical, but until it's done, it's not done.

Okay. Thank you for all that. Very informative.

Thank you, Robert.

Will Avery
CFO, PharmAla Biotech

Okay. Conway, where were we at with the questions?

Conway Gaskin
Digital Marketing Manager, PharmAla Biotech

A couple more. Is PharmAla supplying the VA for their trials?

Nicholas Kadysh
CEO, PharmAla Biotech

Look, the answer is yes. Our contracts are not with the VA directly. That's not how this works. The VA funds trial sites, and we are contracted to supply a number of VA sites. We're also looking forward to more grant funding flowing this year, this year being 2025, for groups such as the Defense Health Agency in the U.S., which had a very large public call. That's $10 million for MDMA PTSD research. I hope to be able to hear and announce which researchers are going to be getting that grant funding as well.

Conway Gaskin
Digital Marketing Manager, PharmAla Biotech

Awesome. Any upcoming news from Cortexa?

Nicholas Kadysh
CEO, PharmAla Biotech

Guys, we get this all the time. We do not front-run the news. We do not announce news before it is announced. Please do not ask this question in the future. The news comes out when the news comes out. Go ahead, Conway.

Conway Gaskin
Digital Marketing Manager, PharmAla Biotech

Implications for MDMA with RFK's confirmation and subsequent FDA approval over the next three months for a long-term investor.

Nicholas Kadysh
CEO, PharmAla Biotech

Okay. Look, I have just personally, on a personal note, I've been absolutely blown away by how the issue of MDMA-assisted therapy and psychedelics more broadly have changed in the U.S. over the last few years. When we started PharmAla, I would still say this was considered in the U.S. like a left-wing coded issue. I think now, especially in the U.S., more than anywhere else, it is either a bipartisan issue or even maybe a soft Republican coded issue. However, despite all that, I do want to temper expectations on what will happen in the U.S. as a result of one cabinet appointment. Regardless of whether RFK Jr. gets confirmed or not, I really don't have any way of knowing what the legislative and regulatory priorities are for either the Trump administration or for him.

I can say there's a number of folks around the cabinet table who are supportive. In December, I met with the new National Security Advisor, Mike Waltz. There have been public comments by the new Defense Secretary, Pete Hegseth, who have all been quite vocal. They're all veterans. They've all been quite vocal about their support for psychedelic-assisted therapy, specifically for veterans and especially for MDMA-assisted therapy. That doesn't necessarily translate to rapid action. I don't want people to assume that one appointment to cabinet is going to be a complete game changer. It might be, but we don't run our business that way. That's not how we plan. We will keep working with our partners in the U.S. We do consider that a growth market for us. Certainly, that's where we've seen a lot of growth in the last six months or so.

We will try to capitalize on all of the opportunities that we see there.

Conway Gaskin
Digital Marketing Manager, PharmAla Biotech

Awesome. Good segue into the next question. In connection with information included in our previous news release, is PharmAla still considering setting up in the U.S., either for a sales office or to produce directly there to supply all of our American contracts?

Nicholas Kadysh
CEO, PharmAla Biotech

Will?

Will Avery
CFO, PharmAla Biotech

I'll take this one, Nick. I kind of touched on that in my section. We are still looking for a U.S.-based distributor. We anticipate doing a material amount of business in the U.S. over the next 24 months and expect that a U.S. distributor will not only lower our cross-border trade risk, but also just simply make our operations there more straightforward.

Conway Gaskin
Digital Marketing Manager, PharmAla Biotech

Awesome. What do you think about the recently announced international collaboration announced between the U.K., Canadian, and U.S. psychedelic industry leaders? Do you think it will bring significant positive change to the industry?

Nicholas Kadysh
CEO, PharmAla Biotech

Okay. This is a PsyCan initiative. Obviously, I am the board chair at PsyCan, but this is not an initiative that I was personally heavily involved in. Basically, you heard about it when it was a done deal. It was done by our executive director at PsyCan. I am going to limit my comments to the following. Number one, PsyCan is a trade association. They do influence things over the long term, but they have a mandate to work on behalf of the entire industry, not on behalf of any specific company. I like doing work with PsyCan. I think a rising tide lifts all ships. I think it is important. I do not think that any initiative at PsyCan will have a specific measurable impact on our financial performance in the short term. In the long term, absolutely. In the short term, not so much.

The other thing I will say is this specific thing, which is basically a collaboration between trade groups and lobbying entities in three different countries, in the U.K., in Canada, and in the U.S., is largely about exporting best practices. I think personally, if I had to pick a jurisdiction with the best practices right now, it's actually Australia. A lot of it is trying to take the Australian model and shove it into government ears in Canada, in the U.K., and in the U.S. We will see what the results are. I don't anticipate it will bring massive sea change in the short term.

Conway Gaskin
Digital Marketing Manager, PharmAla Biotech

Yeah, that's all we have for submitted questions.

Nicholas Kadysh
CEO, PharmAla Biotech

Okay.

Will Avery
CFO, PharmAla Biotech

Yeah.

Nicholas Kadysh
CEO, PharmAla Biotech

Okay. Listen, thank you very much for joining, everyone. Nice to the point, 25-minute webinar. In the future, we're always happy to field questions, but we do need time to review. For something like this, we need time to review them. I know I see some questions sent into the chat. As per our instructions, unless you are a professional working as an analyst, you do need to register in advance, and you need to send in your questions in advance, and we'll be more than happy to field them. I will try to do some more AMAs on the forums, but really, we are quite busy in trying to get some actual work done for the company. That remains our number one priority. Once again, thank you very much for joining.

Will, thanks for the recap, and look forward to speaking to all of you soon.

Will Avery
CFO, PharmAla Biotech

Yeah. Great time today, folks. Hopefully, you all found it useful.

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