Hemostemix Inc. (HEM) Earnings Call Transcript & Summary

June 6, 2025

TSX Venture Exchange CA Health Care shareholder_meeting 66 min

Earnings Call Speaker Segments

Thomas Smeenk

executive
#1

Well, welcome to the Annual General Special Meeting of Shareholders of Hemostemix Inc. My name is Thomas Smeenk. I'm the CEO of the corporation, and I'm pleased to act as the Chairman of the meeting. In the interest of shareholders' accessibility to the Annual General Meeting globally, this meeting is being held via Teams. Consequently, all voting was conducted by proxy and is recorded according to the votes registered by Computershare in accordance with the bylaws of the corporation and the Alberta Business Corporations Act. The meeting will now come to order. If there are no objections, I request Loran Swanberg to act as secretary of the meeting and Pauline Osayande of Computershare Trust Company to act as the scrutineer for the meeting. I will now ask the Secretary to confirm proof of mailing of the Notice of Meeting, form of proxy -- just give me a minute while I admit other shareholders. I will now request the Secretary to confirm proof of mailing of the Notice of Meeting, form of proxy and management information circular was sent to the registered shareholders of the corporation.

Loran Swanberg

executive
#2

Mr. Chairman, proof of mailing has been duly filed, and I recommend that copies of the Notice of Meeting and proof of its mailing be kept with the records of this meeting.

Thomas Smeenk

executive
#3

The Secretary has noted that proof of mailing has been duly confirmed and filed, and I direct that copies of the Notice of Meeting and proof of mailing be kept with the records of this meeting. The scrutineer's report has now been received, and it shows that there are presently at the meeting -- Pauline, do you have a number of shareholders approximately? We have registered present at the meeting 29 shareholders holding or represented in person and by proxy approximately 50,685,723 common shares or 34.88% of the issued and outstanding common shares. I direct a copy of the scrutineer's report be kept with the records of this meeting, and I confirm that a quorum has been established for this meeting. I now declare that the meeting is regularly called and properly constituted for the transaction of business. The audited financial statements for the years ended December 31, 2024, and December 31, 2023, and the report of the auditors thereon were mailed out to shareholders along with the management information circular for the meeting, and they can be accessed on the corporation's website at hemostemix.com and on the SEDAR website at sedarplus.ca. I propose that we dispense with the reading of the financial statements and the auditor's report, and I now ask if there are any questions concerning the financial statements. Accordingly, I confirm that the audited consolidated financial statements of the corporation for the year ended -- for the years ended December 31, 2024, and December 31 2023, the auditor's report thereon, and the related management discussion and analysis should be included as part of the formal record of this meeting. The second item of business for this meeting is to fix the size of the Board of Directors at 4 members for the upcoming year. As there were no further nominations recorded in advance of the meeting in accordance with the bylaws, there are no further nominations. Could I please have a motion to fix the size of the Board of Directors at 4 members?

Loran Swanberg

executive
#4

I, Loran Swanberg, move that the Board of Directors of the corporation be fixed at 4 members.

Thomas Smeenk

executive
#5

I, Thomas Smeenk, second the motion. As 99.82% of the shares voted in favor of this resolution, the motion is carried. It is now in order to proceed with the election of the directors of the corporation. In the management information circular, it was proposed that 4 individuals be nominated for election to the Board. May I have the nominations, please?

David Reese

attendee
#6

I, David Reese, nominate Mr. Peter Lacey, Mr. Thomas Smeenk, Dr. Ronnie Hershman, Mr. Loran Swanberg for election as directors of the corporation to hold office until the next Annual Meeting of Shareholders unless his office is earlier vacated in accordance with the bylaws of the corporation.

Thomas Smeenk

executive
#7

I now declare the nominations closed. As there are a majority of shares voted in favor of each of Dr. Hershman, 100%; Mr. Swanberg, 100%; Mr. Smeenk, 99.44%; and Mr. Lacey, 99.42%, I hereby declare those nominated are elected to the Board of Directors of the corporation to hold office until the next annual election of directors unless their office is earlier vacated or their successors are appointed in accordance with the articles of the corporation. The fourth item of business -- just allowing some other shareholders in. The fourth item of business is the appointment of auditors. Could we please have a motion with regard to the appointment of auditors until the next annual meeting? And could this motion provide that the auditor's remuneration be fixed by the Board of Directors?

David Reese

attendee
#8

I, David Reese, move that MNP LLP chartered accountants be appointed as the auditors of the corporation until the next annual meeting or until a successor is appointed and that the remuneration be fixed by the Board of Directors.

Loran Swanberg

executive
#9

I, Loran Swanberg, second the motion.

Thomas Smeenk

executive
#10

As 100% of the shares were voted in favor of this resolution, the motion is carried. The final item of business is approval of the stock option plan. The full text of the resolution approving the stock option plan is set out in the information circular. I will now ask for a resolution approving the stock option plan.

David Reese

attendee
#11

I, David Reese, move that the ordinary resolution approving the stock option plan as set forth in the information circular be approved, ratified and confirmed.

Loran Swanberg

executive
#12

I, Loran Swanberg, second the motion.

Thomas Smeenk

executive
#13

As 98.66% of the shares voted in favor of the resolution, the motion is carried. As there is no further business to be brought before the meeting, I would request a motion to terminate the meeting.

David Reese

attendee
#14

I, David Reese, move that the meeting be terminated.

Loran Swanberg

executive
#15

I, Loran Swanberg, second the motion.

Thomas Smeenk

executive
#16

All those in favor, please signify by saying aye. Contrary, if any, say, nay. [Voting]

Thomas Smeenk

executive
#17

I declare the motion carried, and I declare the meeting terminated. I want to thank you for your attendance of the formal portion of the shareholders' meeting. To provide shareholders with an update and an overview of the company, I would like to present the latest PowerPoint. Following the presentation, we will conduct an open question-and-answer session. And give me a moment.

Unknown Attendee

attendee
#18

Thomas, are you aware your video's turned off?

Thomas Smeenk

executive
#19

Yes. So I will make some forward-looking statements to give shareholders an appreciation of our business plan for the balance of the year. As you know, we are treating peripheral arterial disease in its most critical form, chronic limb-threatening ischemia. As well, we have a treatment for angina, congestive heart failure, ischemic and non-ischemic dilated cardiomyopathy and vascular dementia. ACP has been used in the treatment of vascular dementia, and we have a clinically relevant case study in Mrs. L. They say a picture is worth a thousand words. And the picture here in the top left Slide A is a picture presented to the 41st meeting of vascular surgeons by the University of Toronto and The University of British Columbia. It's showing a limb that is suffering from chronic limb-threatening ischemia. The toe is gangrenous. You can see the limb is quite inflamed. The patient is suffering at a pain level of approximately 10 out of 10. And on the right is the same foot 4 weeks later following treatment with ACP-01. This is indicative of how ACP works. It heals ulcers. It generates new circulation where the body signals that need. The company has been at this now for some 21 years. We have raised $49 million. There are 498 patients treated, 9 publications and 7 clinical trials, approximately 91 patents. What we've highlighted in some of our most recent publications is -- including in stem cell therapy and research are the results of the treatment of both ischemic and non-ischemic dilated cardiomyopathy. And that success is really measured by a patient's left ventricle ejection fraction, the volume of blood that is ejected with each heartbeat. In those patients who have the most severe forms of these diseases, left ventricle ejection fraction can go down to as little as 20% or 18%. In a healthy individual, it is typically at 60% or 65%, meaning that 60% to 65% of the blood that is in the left ventricle of the heart is ejected with each heartbeat, and as the disease -- heart disease increases, that volume decreases. What we published in stem cell research and therapy was that in those patients who have the lowest ejection fraction, they saw the greatest increase. And in those patients with what is ischemic cardiomyopathy, we saw up to a 27% increase in left ventricle ejection fraction. And those patients who have non-ischemic dilated cardiomyopathy with ejection fractions of 20% or less, we saw up to a 47% increase in ejection fraction. And so the -- coupled with the other studies of ACP, which are summarized here, what we have is a stem cell that is generated from the patient's own blood that is regenerating circulation where the body signals that need and is here, in 7 studies, demonstrated to be safe and statistically significant and clinically relevant in the treatment of peripheral arterial disease, ischemic and non-ischemic dilated cardiomyopathy and angina. And just to put a fine point on it, in the first study on the left here, 83% of the patients treated were -- saved the limb from amputation. And the second trial, which was 20 patients randomized tend to receive treatment, tend to receive regular care and all were followed for 2 years, what we saw was that in the normal care group, there were 2 deaths and 6 of 8 limbs amputated. In the treatment group, there was 0% mortality and 7 of 10 limbs saved from amputation. And then the -- in the Phase II study, we published in the Journal of Biomedical Research, Environmental Science that there was statistically significant wound healing by month 4, consistent with the picture I showed you earlier. In the 4 heart studies, in the angina study, we demonstrated a whole decrease in the symptoms of angina. This is for -- for patients, this is the equivalent of going from chest pain at rest to no chest pain at rest and only having chest pain during exercise. Secondly, we demonstrated in this study a 27% increase in the 6-minute walk test. And then the 3 studies to the right of 106 patients, 41 patients and 53 patients are 3 studies done by 3 independent teams that demonstrate the same statistical significance in the improvement of the heart's function as measured by the left ventricle ejection fraction, which I summarized earlier. So in summary, the -- we have data here now of 308 subjects that demonstrates that ACP is safe and statistically significant as well as clinically relevant. With Phase II results, this enables us to move forward with the treatment of these patients on an exempt compassionate basis in those jurisdictions where they can be treated under exemption. And of course, there's 2 sides to that. There's the supply side of the equation, producing cells; and the treatment side of the equation, scheduling physician time. What we've announced is a fully funded production agreement with CytoImmune. CytoImmune is a company based in California that has a subsidiary in Puerto Rico. They built, at a cost of $27 million, a CGMP facility that is -- occupies 37,000 square feet, has currently 1 clean room that is certified. They have 4 other clean rooms that are under construction that have all the wiring, plumbing, HVAC completed and literally are ready to go to the next stage of finishing in terms of construction. So I would say that they are 60% to 65% complete. But this is a facility that enables us to supply cells. We -- one of the unique advantages of Puerto Rico, one of the reasons why CytoImmune located in Puerto Rico is because the government of Puerto Rico has the most advantageous structure for biotech companies in the world. And that is best described by the 15-year agreement that Hemostemix has with the government of Puerto Rico under the Act 60 legislation. So Act 60 provides $0.50 back for every $1 of research and development spent in Puerto Rico in cash one time a year. As well, it provides for a tax structure that is grandfathered for the 15-year term. As we know, corporate minimum tax is coming in globally, and this tax structure provides for a lower tax on profit as compared to corporate minimum tax. The -- what this enables us to do then is supply cells. The agreement we have with CytoImmune, which we also announced, is a fully funded production agreement. And how this works is essentially the company pays CytoImmune for its services for the production currently that is for the tech transfer, and CytoImmune has agreed to subscribe those proceeds into Hemostemix' equity in a private placement. We recently announced the closing of a $336,000 private placement with CytoImmune at $0.295. So that gives you the understanding of the mechanics of how we will supply cells and how that supply agreement is fully funded. The markets that we are addressing are very, very significant. In the critical limb ischemia market, this is best described by there are 236 million individuals worldwide who are suffering from the peripheral arterial disease. Approximately 23 million have the chronic or critical form of this disease, critical limb ischemia, and there are approximately 5 million individuals globally that are being amputated each year. That is in the critical limb ischemia side of the market, a market estimated to be an approximately $4 billion market. In the treatment of heart disease, what you and I normally refer to as a buildup of plaque in the arteries, ischemic cardiomyopathy, that drug market is also a $4 billion market, so markets that are extraordinarily large. What we are focused on then is the treatment of these patients who have no options under compassionate use of ACP, and we are also working toward a basket Phase I protocol. Let me describe that for you in some detail. So the -- in the basket protocol, where we have treated ischemic and non-ischemic dilated cardiomyopathy, peripheral arterial disease and vascular dementia, we see that in a basket protocol approach, we have a higher statistical opportunity to prove that ACP works by focusing on each of these indications but focusing on them earlier in the disease cycle. We will also be able to prove economically that it is safe and efficacious to treat these diseases, these individuals suffering from these diseases earlier in the disease cycle. We can do that with a research and development dollar based in Puerto Rico that gets reimbursed to the company. But most importantly, we will be able to prove that ACP saves the health care payer, whether that's an insurance company or a government, in the case of critical limb ischemia, we think it will be something like 3 of 5 years of expenses if we just use a 5-year window and similarly in the treatment of heart disease. And so that is an initiative that we are undertaking. In the -- to -- the second part of the equation really is getting to this patient population, and we've done that in a number of ways and are pursuing this in a number of ways. But most -- in this case, I want to show you that we went to the physicians who have treated the heart patients, and we went to the physicians who have treated the critical limb ischemia patients, and we asked them, really, 2 questions. Question 1, what's the number of patients that we can expect you to refer to Hemostemix on a monthly basis? And question #2, what's the number of patients that you can treat if we refer patients to you as physicians? And we got a range of 6 to 16 patients a month on an inbound referral basis from these physicians. And we have a range of 336 patients a month that can be treated when we recruit and refer patients to physicians that have treated with ACP. And so that gives us a very significant fulfillment of the treatment of these conditions. ACP is the most studied of our products. It's -- but we have a platform technology. Properly understood, Hemostemix is a platform autologous stem cell therapy company. And practically, what that means is the patents are on a composition of matter. What our scientists discovered was that -- and proved to the world was that there were -- there is sufficient stem cells in 250 ccs of a patient's blood that can be used and can be educated to become angiogenic in the case of ACP or can be educated to become neuronal cells, nerve cells in the case of NCP or can be educated to become heart cells, cardiomyocyte cells, in the case of CCP. And so while we are focusing on going to market and treating the patients with ACP, we have an opportunity with NCP and CCP, and there are -- there is work going on behind the scenes in the development of NCP and in the development of CCP. It's worthwhile to understand the -- how -- what the patient experience is on the one hand but how this is scalable on the other hand. So the patient on day 1, this patient can be in any doctor's office anywhere in the world, is donating essentially 250 ccs of blood to themselves. That is shipped -- that blood donation is shipped to Hemostemix where it is -- on day 1, where it is converted to ACP on days 2 through day 5. It goes through a quality control, quality assurance check on day 6, while it is being transported back to the treating physician who is in an appointment with that patient on day 7 that is prescheduled. And if you're going to compare that -- if you compare that to a bone marrow extraction, for example, a patient has to go into a hospital for a bone marrow extraction procedure, a blood donation as we -- as those of us who donate blood know, a blood donation can be done literally in any doctor's office anywhere in the world. Why physicians and patients like it is because ACP is safe. This meets the first edict of a physician, which is do no harm. It's -- there's no concern about the source of cells because the cells are coming from the patient's own body. From a physician point of view, this is a product that can be administered safely, especially in the case of critical limb ischemia, in an outpatient setting in the doctor's office. So you can imagine that, on day 1, the patient is at the doctor's office, providing the blood on -- is scheduled back to the doctor's office a week later and is in a 30-minute outpatient procedure where the doctor is doing injections of ACP into the calf muscle of the affected limb. From a physician point of view, if you just project $1,000 a patient, if that physician is focused on -- with a nurse doing 4 blood draws a day of this patient type and a week later, doing 4 30-minute procedures, at $1,000 each, that physician is adding $1 million of revenue to their top line. Four blood draws a day for Hemostemix, on the other hand, is generating 80 patients a month from that 1 physician. And you'll see that in our cash flow projection, 20 patients a month is generating, in Canadian dollar terms, approximately CAD 12 million a year. So 1 physician doing 4 blood draws a day is obviously doing 4x that in Hemostemix revenue, if you will. Our historical time line takes you through when the company was founded, when the team won the World Economic Forum Technology Pioneer Award for proving to the world that there's sufficient stem cells in 250 ccs of blood from which a therapy can be generated and then takes you through each of our clinical trials when these studies were published in peer-reviewed journals. From a competitive point of view, we show BioCardia here. BioCardia recently announced the CardiAMP Phase III study. This is a competitor that's using a bone marrow extraction, generating a stem cell product from that -- from the patient's bone marrow and treating the heart with the product, CardiAMP. Unfortunately, BioCardia failed its Phase III clinical trial and failed to demonstrate improvement in left ventricle ejection fraction. BioGenCell is here just completing a Phase II. They have not announced their Phase II results. As you know, we have announced our Phase II results and are moving forward into a Phase III clinical trial of critical limb ischemia. And LifeCell is here to give shareholders a point of -- a data point as it was bought by AbbVie for approximately $3.8 billion cash. So it's a blue sky exit data point if you will. So our path to market is the treatment of no option patients on an exempt compassionate basis in those jurisdictions where they can be treated. For example in Canada, we have legislation that permits the treatment of Americans or Europeans under exemption. And we're working both in Toronto and now in Red Deer with physician teams who are very much focused on treating the critical limb ischemia patients. As well, we're focused on completing the Phase III clinical trial but financing it from cash flows that are generated from the treatment of patients in the basket Phase I clinical trial. Our time line to production is that we are focused on being in production by -- and in revenue by Q4 of this year. And what you'll see is that we've got a plan that initially establishes rate of production at 240 patients a year or 20 a month, generating CAD 12 million top line and then ramping that up to 30 a month and 40 a month and 80 a month, again, 1 doctor, 4 patients a day, 80 patients a month. So we -- you'll see from our cash flow projection that this is a very conservative cash flow projection on the one hand and very realizable on the other hand because we have a fully funded production agreement with CytoImmune. We have currently approximately 148 million shares issued, approximately 75 million warrants extend generate about $6.5 million in warrant financing for the company. The warrants are callable, if you will, by the company or can be accelerated is actually a more accurate term, meaning that, typically, if the stock trades at a premium to the warrant exercise price for 10 consecutive days, then the company can notify the warrant holders of the early exercise of those warrants via the issuance of a press release. Rather than call the -- rather than calling the warrants, we are on -- focused on calling or speaking with shareholders who hold the warrants to talk to them about the orderly exercise of warrants as the warrants are in the money. Our -- going to our cash flow projection, you'll see that we are essentially focusing on, as mentioned, 20 treatments a month, 240 a year, ramping that up to 40. The -- we've been conservative and are using a 75% estimate of capacity utilization, taking us -- if we're projecting 40 a month, we're actually doing a cash flow model based on 30 patients a month. And this generates, over the next 5 years, $53 million in cash flow for the company. Again, I think it's -- based on the number of patients, this is really a very conservative cash flow projection. So the key takeaways are that we have a stem cell that works that's demonstrated to be statistically significant in the treatment of a number of cardiovascular indications, including in the limb, in the heart and in the brain, in treatment of vascular dementia. We have a platform technology. We have other technologies that are equally as promising. We have a fully funded production agreement, which enables us to produce ACP for sale as treatment to no-option patients. And we have a clinical trial strategy that enables us to complete the treatment of each of these indications earlier in the disease cycle, leverage that data to get approval from the FDA and simultaneously leverage the cash flow of both the treatment of no option patients and the Phase I patients to fund the Phase III clinical trial. There's -- in the -- we've come through what was called the nuclear winter for biotechnology companies over the last 3 years and anyone that is invested in the junior end of the market knows that these companies and these sectors come into favor, out of favor whether that's in the resource sector or in the biotechnology sector. And happy to report that we've weathered that winter and are now in a position to monetize the technology. In the life sciences investment space in 2024, there was approximately $2.4 billion of M&A activity in the stem cell space. The largest deal was a $1.2 billion buyout, and this was in the NK, natural killer cell stem cell space. One other data point here is Bristol Myers paid $13.8 billion cash for MyoKardia for the treatment of non-ischemic dilated cardiomyopathy. The drug that they bought, when they bought MyoKardia is named mavacamten. Now Bristol Myers recently in the last number of months, last 3 months, announced the Phase III, a very -- I think it was 568-patient Phase III clinical trial. And unfortunately, mavacamten did not meet the end points in the Phase III trial. So Bristol Myers is obviously looking at this, but they -- it gives you another data point, if you will, that, I think, the blue sky on the stock is very significant and it behooves us to not only reach out to competitors like BioCardia but to competitors or larger companies like Bristol Myers who have an interest in the treatment of dilated cardiomyopathy. And with that, I want to thank you very much and open it to questions.

Unknown Attendee

attendee
#20

Thomas?

Thomas Smeenk

executive
#21

Yes.

Unknown Attendee

attendee
#22

This is [ Sid Bass ] in Calgary. You had mentioned about the warrants being exercised or holders being encouraged to exercise when they're in the money. What does that mean, the warrants are -- the warrants are exercisable at $0.12, I believe. So does that mean when they're at $0.13 or $0.14, you're going to encourage investors to exercise the warrants?

Thomas Smeenk

executive
#23

Yes. Yes, it does.

Unknown Attendee

attendee
#24

Thomas, I believe [ Dan O'Day ] raised his hand to ask a question.

Thomas Smeenk

executive
#25

Okay. Sure. I'm trying to unmute [ Dan ]. I'm going to try this. [ Dan ], is that working?

Unknown Attendee

attendee
#26

May be muted at his end.

Thomas Smeenk

executive
#27

Yes.

Unknown Attendee

attendee
#28

[ Dan ], can you see your microphone icon? [ John Roozendaal ], you're unmuted.

Unknown Attendee

attendee
#29

Yes. Thank you very much for that presentation, and it's staggering to see the levels at which, I don't know, the commerce takes place in this industry and given where this company is, it's a 1 -- it's easy to be offput to -- but to see such a scalable item. By having lived in the junior mining and mineral exploration world, I know what a 1,000 to 1 win looks like. They do occur [ 100 to 110 to 1 ]. It seems like, at this stage, the company is advancing. There's a certain point where you cross over and you do become of interest. And it looks like same with -- in the mining space, which you're familiar with. There's different tiers of companies and you've illustrated, too. Obviously, you can't predict when that could happen. But is it something that could [indiscernible] or the company's progress or some combination, you think?

Thomas Smeenk

executive
#30

Yes. I mean the -- yes, exactly. Obviously, very forward looking. The -- my personal view is that once we are treating and that we are demonstrating the positive cash flow in 2026 and even as we get there, but I mean, obviously, proof is in the cash flow. And that is going to have, I think, a dramatic change in valuation. I think the other value drivers are going to be when we -- what we've done, which is very unique is -- or at least it's unique in biotech. It's not unique in gold mining. As you know in gold mining, you can do a forward sale. You sell your production forward. You take the proceeds. You produce the gold. You deliver the gold and you repeat the process. In -- it's never been done in biotech. And -- but we have borrowed that strategy and are selling ACP therapies forward to patients so that they know if they're patient #499 or 525. It enables us to schedule production at a rate that's consistent with the forward sales and forward demand, and it enables us to schedule physician time to -- in the most logical way. And so what you'll see as a value driver between now and December is continuous announcements of forward sales of treatments, especially to the no option patients obviously and to those patients who want to be included in a vascular dementia trial or who are suffering from angina and want to be -- have just been diagnosed with angina and rather than living with it for the next 10 years in increasing pain, want to address it upfront and want to be included in a Phase I trial, the treatment of angina. So those are valuation drivers that you'll see. Other valuation drivers like that will be announcements of operating clinics that have agreed to treat with ACP under exemption in their jurisdiction where they have government approval to do so. And we'll commit to either a set patient number a month that we will generate for them or we'll commit to an offtake agreement and say we think given our position, skill set that we can commit to doing, pick a number, 4 a week. And so those are agreements that we're driving towards that will have, I think, a significant impact on valuation going forward.

Unknown Attendee

attendee
#31

I know that wasn't easy question because you're trying to look forward and try to explain to someone like myself what -- how this industry works. But I gather -- I think I get the gist. Stay tuned.

Thomas Smeenk

executive
#32

Yes, yes. Thank you, [ John ]. [ Dan ] has posed a question in chat. So let me see if I can get there. So thanks for your presentation. Can you comment on your patient acquisition strategy? Is the current strategy to engage strategic partners? And last one, can you comment on FDA submissions? So patient acquisition strategy is going to -- is really -- you can think of it, there's the 2 strategies. One is dealing with the physicians who have treated this patient population and letting them know, again, that we're looking for their referrals. And there, we think we'll see initially 6 in a month and then that grow up to 16 a month. That's sort of on the inbound side. The outbound is very much a focus on using social media to reach patients where they are at home or said another way, to reach the caregivers of the patients where they are. And so what that looks like is someone who has an elderly loved one who is suffering in pain 8 out of 10, 9 out of 10, 10 out of 10 pain scale is online looking for solutions for the treatment of critical limb ischemia. And when they are online looking for it, we will be naturally one of the results that are -- that pop up. We will have ads that are focused on this -- our treatments, and we will increase the volume of social media that we are doing so that the caregiver, number one, gets the information they need for the treatment; number two, comes into our sales funnel and is handled or is managed in the appropriate way. We have a lot of experience in this and have been adding team members, which will -- who have the skill set to drive patient engagement in each of the indications that I've mentioned. Strategic partners, yes, that's, I think, another valuation driver. There are strategic partners. You can think about them on a number of different levels. Obviously, you can think about it on a geographic basis. You can think about it on an indication -- medical indication basis. And you can think about it in terms of sales platform basis. So in addition to the company focusing on target marketing in those jurisdictions where patients can be treated or close -- in close proximity to those jurisdictions, for example, South Florida to be treated in the Bahamas or Michigan to be treated in Toronto, there are platform providers. You think of it like an Amazon-like platform that are just focused on the stem cell treatment space and have amassed up to 200 clinics on 1 platform that are offering stem cell treatments. Currently, they're offering an allogeneic stem cell treatment. They're offering a donor-based stem cell that has no scientific basis of proof that it's safe or that it's effective but has patient testimonials and have some clinical evidence that it works. They're certainly able to treat. And there's some 5,000 of these stem cell clinics worldwide. So we have a -- in terms of patient acquisition and in terms of going after strategic partners, one of those strategic partners are the platform providers themselves who have the 200 clinics to engage them in getting our message out to the 200 clinics on their platform. In terms of FDA submission, it's -- we are working with -- at the CytoImmune. Part of the CytoImmune team includes a regulatory team who has deep experience, including a number of years of working inside the FDA within our space in the autologous and allogeneic stem cell space. So we have -- we're well advised and are working on an FDA submission that is a basket protocol submission. So thank you for those questions, [ Dan ].

Unknown Attendee

attendee
#33

Thomas, can you hear me?

Thomas Smeenk

executive
#34

Yes.

Unknown Attendee

attendee
#35

Yes. In your presentation, you spoke about treating patients [indiscernible] Toronto and possibly Red Deer. [indiscernible] could you elaborate a little bit more on what that [indiscernible]?

Thomas Smeenk

executive
#36

Sorry, can you repeat the question because I -- while I can hear you, I could not discern the question.

Unknown Attendee

attendee
#37

Is that better? Can you hear me now?

Thomas Smeenk

executive
#38

Yes, yes.

Unknown Attendee

attendee
#39

Thomas, I think the question was could you elaborate on any procedural strategies in either Red Deer or Toronto?

Thomas Smeenk

executive
#40

Sure. So the -- within Canada -- in Canada, we have a special access program that enables patients to be treated under exemption and enables them to pay for that treatment. So the -- this is really the fulfillment, if you will, the physician -- scheduling of physician time to get the treatment done. And so the -- in Toronto, we're working with a team who was a principal investigator in the Phase II clinical trial at a very well regarded institution. I think they rank in the top 5 in the world for their -- as a health care institution and so working with them to get through ethics approval and then be in a position to treat those Americans, those Europeans who can afford to be treated in Toronto. Similarly, in Red Deer, we've met with a team that has, on the one hand, a private practice that enables the treatment of patients with critical limb ischemia. In Red Deer, they can recruit globally to be treated in Red Deer. And this group also has 51 clinical trials underway currently that they're managing, and they're very interested in the Phase III clinical trial as well. So it's very interesting for Hemostemix because, obviously, the more physician teams that we have -- again, go back to the analogy of 1 physician doing 4 blood draws as 80 patients a month. The more clinics we have with the more teams that can treat, obviously, just magnifies the opportunity for our shareholders.

Unknown Attendee

attendee
#41

Thomas, [ Barry Muir ] here. What about the situation in the States in like Georgia or Florida? Are there any opportunities there to have procedures done there similarly to what you just mentioned in Toronto and Red Deer?

Thomas Smeenk

executive
#42

Yes. We're continuing to -- as we all know, the environment south of the border continues to change daily. But the current regulatory regime is that while Americans have the right to try therapies like this to save their life, save their limb, the company is prohibited from selling it at a profit. We can sell it at cost. So what makes the most sense is to recruit from the States and treat those patients in Canada or in the Bahamas or in other jurisdictions where they can be treated.

Unknown Attendee

attendee
#43

Thomas, can you give any update on your recent trip to Europe [indiscernible]?

Thomas Smeenk

executive
#44

Trip to where, sorry?

Unknown Attendee

attendee
#45

Europe.

Thomas Smeenk

executive
#46

Yes, sure. So pitched in Stuttgart -- in 4 cities, so Stuttgart, Zurich, Friedberg, Frankfurt and London and to biotech -- this was a biotech savvy group in each city and very, very good reception. I think we've -- this will be measured in announcements of, I think, treatments, of sales, and it will be measured in participation in other -- whether it's financings. And then they've got -- the Europeans have -- from a regulatory point of view, they're even more conservative than the FDA is, but they're looking for and thinking about ways that we can treat in jurisdictions that are close to Europe or in a most favorable jurisdiction in Europe that is a developing country. And so there's a number of conversations on the go in that way.

Unknown Attendee

attendee
#47

Thomas?

Thomas Smeenk

executive
#48

Yes.

Unknown Attendee

attendee
#49

It's [ Sid ] again. What is the current cash position at this moment? And how many forward sales have you achieved to date?

Thomas Smeenk

executive
#50

Yes. So we've -- I'm going to answer those in the reverse. We've announced, I think, 23 forward sales for about $1.1 million, and the company's current cash position is just under $1 million.

Unknown Attendee

attendee
#51

Thomas?

Thomas Smeenk

executive
#52

Yes.

Unknown Attendee

attendee
#53

Is there the ability for Canadians to take treatments in a different province than what they live in also? And now is that limited to the special last choice, last available option? Or is that -- if you go to the other province, can you -- can anybody do that no matter their health situation?

Thomas Smeenk

executive
#54

That is something that is being explored. I don't have a definitive answer on this yet, but it does appear that given the interprovincial trade barriers that an Albertan can come to Ontario and pay to be treated in Ontario. An Ontarian can go to Alberta and pay to be treated in Alberta. But that's not definitive yet, but it does look very promising.

Unknown Attendee

attendee
#55

Thomas, I've got a client who's got a question, and he's wondering when CytoImmune will be ready to actually accept samples and begin treatments.

Thomas Smeenk

executive
#56

Yes. So currently, we expect that we will be up and running by the end of Q4. [ Linda ], I can't seem to unmute you. Could you type your question please?

Unknown Attendee

attendee
#57

Thomas, will this be recorded and presented on the website?

Thomas Smeenk

executive
#58

This meeting has not been recorded, so it will not be presented on the website. Okay. Well, thank you for...

Unknown Attendee

attendee
#59

Thomas, one follow-up question to the question I asked about the cash position. You said that there is currently just under $1 million. Does that include funds from the 23 forward sales? In other words, if you didn't have those, you'd be in a negative cash position.

Thomas Smeenk

executive
#60

The -- so the short answer is yes. The -- but the longer answer is that we are continuing to sell the therapies forward and have good -- very good prospects that way.

Unknown Attendee

attendee
#61

If I could just maybe add something quickly, the way the therapies are being sold forward is in what's being called a therapeutic convertible debenture. So it will look like a normal convertible debenture with one other alternative for conversion, which is into the therapeutic treatment. So the slightly longer answer to your question is when we sell one of these treatments forward, it is cash that comes to Hemostemix that's available to Hemostemix. And obviously, Hemostemix needs to keep -- make sure it has the cash required to produce the actual treatments, which it is doing. We've got that all squared away for at least the first 22 batches, just to give a bit more color to that.

Thomas Smeenk

executive
#62

Well, thank you very much. It's a pleasure to be with you today and look forward to your follow-on questions or e-mails. And again, I wish you a great day. This will conclude our shareholder -- the informal part of our shareholder meeting.

Unknown Attendee

attendee
#63

Thanks all. Cheers.

Unknown Attendee

attendee
#64

Thank you, everyone. Bye now.

Unknown Attendee

attendee
#65

Bye.

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