CytoMed Therapeutics - H1 2024

Transcript

Operator (participant)

All right, I think it's 9:00 P.M. Singapore time and 9:00 A.M. over in New York. Peter, do you want to start?

All right, you can, you can see me, yeah?

Yep.

Okay. Good morning, all our friends, shareholders, ladies and gentlemen in the US, and a very good evening to all our shareholders and friends in Singapore, this is where we are based, and Southeast Asia. So, welcome to our first half earnings call results briefing for the first six months, ended thirty of June, 2024. There will be an opportunity to ask question at the end of our presentation, or if you prefer, you can text us privately through our email if you want to ask, you know, certain questions, these are privately. So my name is Peter, and I'm the chairman. Let me introduce you to my team. I've got our Co-CEO and Chief Operating Officer, Dr. Tan Wee Kiat. He will be talking on the business of CytoMed.

And then, our CFO, Yvonne, will be talking about the financials. Right. So also on this call is our other senior colleagues, our Senior Finance Manager, Dr. Dean, and Chief Operating Officer, Evelyn. So let me just now jump into it. I think we have achieved a lot since our listing last year on NASDAQ in April 2023. In this short one and a half years since our listing, we have really make very good use of the money we raised from the small IPO we did last year. We raised about $10 million, and we still have $5 million of that, which will be put to good use for the rest of the following year. So I think a lot of our performance is actually due to the fact that we operate in Southeast Asia, right?

I think that really puts us apart from many other biotechs. The low-cost structure enable us to produce mixed cells that will be affordable. I mean, there's no point coming out with therapies that cost, you know, a few hundred thousand dollars. The insurance company will balk at it. So our mission is to make affordable cell therapies, right? And the low-cost infrastructure in Southeast Asia actually goes a very long way, right? As you can see, our results, you know, compared to many of the US biotechs, we actually. I like to say that my team did a good job. So I am now. The company is very excited going into 2025 and for the rest of the year, another three months, the last quarter, and next year, 2025.

We are very excited because we have a few things going on. One, I will just highlight two. One is that, we are going to, or we should be, become clinical stage in this last quarter because we have had our investigator site meeting already and, patient selection already, at least for the initial few patients. So we will you know, announce our first patient in the last quarter, this quarter. So we will become clinical stage, which is a very important milestone for a biotech. And the second thing I want to highlight before I pass you over to our CFO, Yvonne, is there is a rising interest in our product, which is the allogeneic gamma delta T-cells, which we make very affordably, right? Helped by the low-cost infrastructure in Southeast Asia.

So now there is a lot of interest in this allogeneic, off-the-shelf gamma delta T-cells, right? Which, because it is off-the-shelf, it can be made very affordable, right? There's a lot of interest shown because of the inquiry we received to explore usage of the cells in various treatment modalities. So this is a rising interest, the whole world, in gamma delta T-cells, because it does not cause rejection issues, right? So I think with this very short comment, I will now pass you over to our CFO, and then our Chief Operating Officer and co-CEO, Dr. Tan, will talk on the business. Thank you very much. Yvonne, please.

Yeah. Thank you, Peter. Good morning and good evening, everyone. Thank you for joining our earnings call. Before I kick off my presentation, please note that we will be making forward-looking statement today, which may differ materially from actual results. Please review our legal disclaimer included in our presentation carefully. I will now give a broad overview of the six months ended June thirtieth, 2024, financial performance. We reported a net loss of SGD 1.09 million, equivalent to $803,000 for the six months ended June thirtieth, 2024. If excluding the cost associated with being a publicly listed company on NASDAQ, the net loss will be reduced to SGD 935,000, or $690 US dollar.

Our other operating income for the six months ended June thirtieth, 2024, increased by 80.5% year on year. Loss per share was $0.09. As of June thirtieth, 2024, we recorded a net asset position of $10.16 million. Net operating cash outflow was $1.16 million. CytoMed ends the six months with a cash and bank balance of $6.7 million. We move on to the next slide. This table shows the financial performance for the six months ended June thirtieth, 2023 and 2024. We have seen a significant improvement in our financial performance. Our other operating income increased by 80.5%, reaching $422,000 this year, mainly due to higher interest income from our IPO proceeds placed in fixed deposit, amidst a slight decrease in research income.

We have also recorded other gains of $361,000, a reversal from $18,000 loss in the same period of 2023. This was driven by net currency exchange gains and fair value gains on warrant liability. However, our research expenses increased by 20.1%, reaching $974,000 as we continue investing in our preclinical activity and advancing our immunotherapy pipelines. The increase was mainly attributable to an increase of preclinical expenses, higher employee benefit, and partially offset by a reduction in our lab consumable, decrease in professional fees, and also depreciation expenses. General and admin expenses decreased significantly by 39.9%, mainly due to the absence of the IPO-related professional fees. As a result of the foregoing, we recorded a net loss of $1.09 million for the six months ended June 30, 2024.

If the costs associated with being a public listed company are excluded, the net loss will reduce to SGD 935,000, or equivalent to $690,000. We expect our expenses to increase in connection with our ongoing activity, particularly as we conduct the ANGELICA clinical trial with National University Hospital, Singapore, and advance the preclinical activity of our product candidates. Over to you, Wee Kiat.

Tan Wee-Kiat (Co-CEO and COO)

Right. Thank you, thank you, Peter, and thank you, Yvonne. So let me now share with you the recent highlights, what are our progress, as well as our update on each of our program. So recent highlights in first half twenty twenty-four, we have received co-funding support from NMRC, clinical, called the Clinical Trial Grant for our clinical trial with National University Hospital, Singapore, for CTM-N2D, which is our lead candidate. We have also completed acquisition-

Sorry to jump in here. NMRC is the national. It stands for Singapore, the National Medical Research Council, which is the national medical research, you know. They grant the funding, so it's at national level. Yeah. Sorry, We Kit.

Yes, yes. Thank you, Peter, for clarifying. Right. So we have also completed acquisition of cord blood banking license and assets, which expands CytoMed's strategy to cord blood-derived biologics through our subsidiary, Longevity Bank. And we have also continued expansion of clinical capacity and business throughout the year. Now, looking at the pipeline progress for each of our product. So Project One, that is CTM-N2D, which is our current gamma delta T. The pink bar denotes the progress that has been made during this timeframe of first half 2024. We have crossed significant milestone.

As updated by Peter, we have collected adequate donor blood, and we are slated for first patient in a key milestone in clinical trial for any biotech, and that will put us into a clinical stage company within the final quarter of twenty twenty-four, so before the end of the year. Moving on to Project Two, which is the iPSC-derived gamma delta NKT. We have generated, stocks of iPSCs or induced pluripotent stem cells, and these stocks of iPSCs has been positioned for good manufacturing practice, GMP master cell bank creation when necessary. The team is also on track for, making sure that we move into preclinical studies next year, and the team has been well-trained on the GMP protocol that we are generating for this project. Now, moving on to project number three, which is CTM-GDT. This is the allogeneic unmodified gamma delta T-cells.

MD Anderson Cancer Center, which we are collaborating on, has generally updated that our cells are highly cytotoxic and have very good cancer killing across the board, and they will be sharing their results in detail in American Society of Hematology, or ASH, at the end of the year. We are also exploring very meaningful collaboration with two other international collaborators, and both of them utilizes antibody for combinational therapy. We have also been making significant partnerships, especially where, in looking into penetrating other markets in Southeast Asia, for example, in India and Thailand, and this would be something that we will be looking to announce soon as we finalize the collaborations.

Now, it has been an exciting first half, 2024, and as we are rounding up 2024, and we also look beyond to 2025, we are very excited to start the first in-human CAR gamma delta T-cell trial in Singapore, expected in fourth quarter, thereby transforming us into a clinical stage company. We are also continuing to pursue the application of gamma delta T-cell trial in Malaysia, as well as other parts of Southeast Asia. MD Anderson Cancer Center has already started their preclinical studies, and that is with a view to submit to support and submit a U.S. FDA IND when the results are out. We are also collaborating with international parties with income potential.

So iPSC Depository, which is a subsidiary of iPSC Bank Private Limited, which has been renamed to Longevity Bank Private Limited, has acquired the cord blood bank, as I mentioned earlier, and this is positioned to be a cord blood-based biotech with its own spinoff potential. We are also looking to be in New York from October twenty-eight to November the second, to meet up with shareholders, investors, and also plan ahead for fundraising that will be slated in 2025. This is the GMP, or Good Manufacturing Practice, facility that we operate from, and as we continue to. It has been audited by Ministry of Health, Malaysia, again, as of May 2024, and we are constantly expanding the team to increase our business and research capability.

This is a showcase photograph of the cord blood unit storage facility that we have acquired that is in Kuala Lumpur, Malaysia. With that, I end my update. Thank you very much, everyone, for your time, and our team will be happy to take any questions. If you have questions that you would prefer to email us, you can go ahead and email us as well. Yes, I've seen that Bruce has raised your hand. Yep, kindly unmute yourself, and you could ask the question.

Hi, everybody. Thank you for taking my questions. First, I wanted to confirm that with the N2D program, you're planning on dosing the first patient by the end of the year. Is that correct?

Yes, that is correct.

Okay, super. And then the trial protocol, will that be the same as what was published in the AACR abstract in April?

Yes, that would be the same. The clinical trial protocol is also available on ClinicalTrials.gov. You just have to look for the ANGELICA trial, and you'll be able to see it as well.

Okay, very good. Then, with the GDT program with MD Anderson, in your press release, you mentioned that they filed a Drug Master File with the FDA,

Yeah

... in anticipation of pursuing the IND.

Right.

What are the next steps, to get to filing the IND, and when do you anticipate that that could take place?

Right. So the drug master file actually have been filed by us by CytoMed, and we are keenly awaiting for the preclinical animal studies to be out, which MD Anderson is currently conducting. Once that is out, hopefully, we could have the data, say, by end of the year. We could start preparing and try to submit it either late fourth quarter or early first quarter for an U.S. FDA IND application.

Okay. Very good, and then a question for Yvonne. With the operating expense profile, how is that going to evolve over the next few quarters? Is it going to be... By the way, very nice job on the expense control. Will the expense profile going forward increase because of the increased clinical trial activity, or will it be about the same as where it's been historically?

Yeah, hi, Bruce.

Yeah, let me answer that, Yvonne.

Sure.

Well, the good news is, we just have confirmation of a grant, which is very nice for us, given our cost structure, right? It will sign- it will help us significantly. We're not supposed to reveal the amount and nobody... It is a nice for us, nice size. Given this sort of climate, you know, where to have grants from a national research agency, it's makes us feel proud, right? So the grant would pay for significant the investigator charges. So we would be responsible for the drug, right, that we are making, right? So I don't think the next half year we will see any big increase in our expenses, right? The phase one trial is only involve about 12, maybe up to 18, right?

But we are hoping to stop at 12 because, you know, this is a phase 1 safety, right? So, with this grant, I do not see a very big effect, at least for six months. That answer your question?

Okay.

Yeah.

It does. Thank you. And then, one last question on the cord bank acquisition that you just completed. Maybe you could tell us what some of the advantages are of owning that facility. I'm assuming that you, in the process of doing that, you get access to some talent, some people, some stability, potentially some other revenue streams. Just, discuss with us the rationale for the acquisition.

Okay. The cord blood bank, we did not acquire the shares of the cord blood bank because, you know, it is... You know, you take the liability also, right? So we bought this license. There are only three such license, all right? It's not available anymore. If you ever want to do banking, this is one of the three last, right? There are only three banking license in the whole of Malaysia. So we bought this one from the liquidator, right? The company probably affected by COVID.

Mm.

Right, so, we bought it from the liquidator. We bought the license and all the equipment and, the 12,000 members, the subscriber, right? Some of them are still paying, right? So, we bought it from the liquidator for a very, attractive pricing, which we disclosed already, is $490,000.

Mm-hmm.

Yeah, so we paid cash. It only cost us $490,000, right? And what we see here, right, you know, traditional cord blood banking is not what we are really targeting, right? Because we like it because, you know, many people have actually told us, many analysts have told us that we should separate these two business of cancer therapeutics, right, cancer biologics, which we have been our pipeline is the three pipeline are all cancer related, right? So they have told us to separate the regenerative one, because we also make stem cells, because we have all the facility, we have all the talent, the scientists, the lab, the GMP facility. So we also make stem cells, right? So they have asked us, "You should separate these two business, right? The regenerative longevity, anti-aging, right?

separate it into a separate subsidiary. So this is a very good opportunity for us, right? That there is a cord bank now with a license. So we... And we bought it very attractive. Now, one of the key asset in there, right, very valuable, right? Which is actually more than the $490,000 that we paid, is actually the reserve, right? The bank of so many cord blood units. It is a very rare and precious asset. You know, when companies or hospitals do research in the lab, we have to buy consumables, right? We have to spend money to buy it, and they're not cheap. Cord blood bank units are very rare. You know, it only comes from the mother, right? So it cost quite a lot of money, right, to buy one unit. One.

So here we have got a lot of donated units that we can readily use to quickly go into cord blood derived biologics for regenerative purpose, right? Which means, you know, now the buzzword is longevity, stem cells, right, anti-aging. So cord blood, being naive from the mother, from the cord, he has got his own special characteristic, right? Compared to what we are using now for the cancer therapeutics, which is just about everybody use, adult blood, right? So suddenly we have this big bank of readily available cord blood units that we can use, right, to derive cord blood. For example, cord blood-derived NK, right? Natural killer cells. I think two months ago on NASDAQ, there is a cord blood-derived NK company called Artiva Therapeutics. Artiva, right? They use cord blood.

Wow, I mean, they were so highly valued, you know? Right, so I don't think they own a cord blood bank, so we are very unusual, right? A biotech with a cord blood license. Very, very unusual, right, so most of the cord blood bank, there are actually they are not like us. Our heritage, our parentage is first as a biotech going into blood banking, whereas the other banks are not. They don't have the biotech heritage, so I hope I answered your question, Bruce.

Oh, that was perfect. That's it for me. Thank you very much for answering my questions.

Yeah. You know, you can email us, you know, or if you want to catch up, I'll be in New York.

Okay, great. Thank you.

Well, anyway, if there's any question, you know, you can email us privately. We are twelve hours apart, but not to worry, we are very passionate about our business, and we're making great strides. I think if there's no more question, I thank all of you for your time and interest in CytoMed. There's a lot of things that, you know, keep us very busy for a small biotech. Okay, good night, and thank you. Goodbye.

Yep. Have a good day, everyone, and thank you everyone for your time. Thank you. Bye-bye.