Humacyte Q3 2023 Earnings Call Transcript

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November 9, 2023

There are 8 speakers on the call.

Operator

Afternoon, ladies and gentlemen, and welcome to the YumaSight Third Quarter Results Conference Call. Currently, all participants are in a listen only mode. Later, we will conduct a question and answer session and instructions will follow at that time. As a reminder, this conference call is being recorded. I will now turn the call over to Lauren Merrick with LifeSci Advisors.

Operator

Please go ahead.

Speaker 1

Thank you, operator. Before we proceed with the call, I would like to remind everyone that certain statements made during this call are forward looking statements under U. S. Federal Securities Laws. These statements are subject to risks and uncertainties that could cause actual results to differ materially from historical experience or present expectations.

Speaker 1

Additional information concerning factors that could cause actual results to differ from statements made on this call is contained in our periodic reports filed with the SEC. The forward looking statements made during this call speak only as of the date hereof, the company undertakes no obligation to update or revise the forward looking statements, except as required by law. Information presented on this call is contained in the press release we issued this afternoon and in our Form 10 Q, which after filing may be accessed from the Investors page of the Humacyte website. Joining me on today's call from Humacyte are Doctor. Laura Nicholson, President and Chief Executive Officer Dale Sander, Chief Financial Officer and Chief Corporate Development Officer and Doctor.

Speaker 1

Heather Pritchard, Chief Operating Officer. Doctor. Nicholson will provide a summary of the company's progress during the quarter and recent weeks, and Dale will review the company's financial results for the quarter ended September 30, 2023. Following their prepared remarks, the management team will be available for your questions. I will now turn the call over to Doctor.

Speaker 1

Nicholson.

Speaker 2

Thank you, Lauren. Good afternoon, everyone, and thank you for joining us for our Q3 2023 financial results and business update call. Our Q3 was a highly productive period for Humacyte, during which we achieved significant milestones in the advancement of our universally implantable bioengineered human tissue product candidate, the human acellular vessel or HAV and we've worked on this in multiple indications. This was led by our announcement in September of positive top line results from our Phase twothree clinical trial in vascular trauma repair, which positions us to submit our BLA filing for approval in this indication during the current quarter. We're also pleased that potential of our HAV pipeline has been shown in other clinical studies this quarter, including the presentation of Phase 2 results in severe peripheral artery disease or PAD.

Speaker 2

In addition, we recently published preclinical results of our small caliber HAV in a juvenile heart disease model. During today's call, I'll review these recent highlights in more detail before turning the call over to Dale for a review of our financial results, then we'll be happy to open the call to your questions. I'll begin with our HAV program in vascular trauma and the positive top line results that we announced from our V05 Phase twothree clinical trial of the HAV in trauma repair. In this clinical trial, the HAV had higher rates of patency and lower rates of amputation and infection as compared to historical published benchmarks of synthetic graft function in trauma patients. A total of 69 patients were enrolled in the VO-five trial 51 of these had vascular injury of the extremities and comprised the primary evaluation group for the study.

Speaker 2

The 30 day patency or presence of blood flow for the HAV in the clinical trial was 90% as compared to nearly 81% historically reported for synthetic graft. Importantly, the HAV also demonstrated lower amputation rates with a rate of 9.8% for the HAV as compared to over 20% being reported historically for synthetic grafts. This means that for a vascular trauma patient receiving the HAV, the chances of amputation are less than half of the chances associated with receiving a synthetic graft. It's also important to note that in the VO5 trial, there were no amputations that occurred because of failure of the HAV. All of the amputations occurred because of severe injuries to the limb and not due to loss of blood flow from the HAV implant.

Speaker 2

The HAV also demonstrated lower rates of infection with an infection rate of 2% compared to over 8% historically reported for synthetic graft. In other words, patients receiving the HAV in this trial were less than half as likely to suffer an amputation and one fourth as likely to have an infection of their graft as patients who historically got synthetic grafts for their injuries. Building on the momentum of these positive results, we plan to submit a biologics licensing application or BLA with the FDA during this quarter. In May of this year, Humacyte received a regenerative medicine advanced therapy or RMAT designation from the FDA, which will allow us to request a priority review of our BLA filing, since we've also received priority designation from the Department of Defense, we believe that we'll have a high potential for priority review of our planned BLA filing in the trauma indication. Further buttressing the real world utility of the HAV in treating injured patients, have been used in Ukraine under humanitarian aid program.

Speaker 2

During the 1 year humanitarian effort, 19 vascular trauma patients received the HAV in Ukraine. Results will also be highlighted from these patients in our BLA filing with the FDA. Outcomes from these 19 patients were described in a presentation at the 2023 Military Health Systems Research Symposium in August, with clinicians reporting a very high success rate in treating these patients with the HAV to date. In war wounded patients in Crane, who suffered blast and shrapnel injuries that were often severe, both 30 day limb salvage And 30 day patient survival were 100%. 30 day patency or blood flow was 95% And there were no reported instances of infection of the HAV.

Speaker 2

We believe that these remarkable results are an important addition to our BLA filing And we're proud to be able to help our Ukrainian surgeon colleagues save life and limb in this wartime setting. Humacyte and our Lab raters expect to make multiple presentations at the Veith Symposium, which is a major vascular surgery meeting in New York next week. These include an expanded presentation of the results of our VO-five vascular trauma trial and also the outcome of research, which seeks to identify which dialysis patients experience the most difficulties with their dialysis access and which patients may benefit from an access that is both durable and resists infection. In September, clinical results were also presented on an FDA regulated investigator sponsored clinical study at the Mayo Clinic. In this study, patients with severe peripheral arterial disease, who face possible limb amputation and who had no vein of their own for bypass surgery were treated with the HAV to restore blood flow to their limb.

Speaker 2

In the presentation at the Midwestern Vascular Conference, Mayo researchers observed that the HAV was a safe, resilient and effective conduit for arterial bypass and limb salvage. This is an important result since approximately 40% of patients requiring lower extremity bypass do not have saphenous vein available. In the future, the HAV may represent a promising alternative for preserving limbs in patients with advanced peripheral artery disease. With regard to publications, in October of 2023, a publication in the Journal of Thoracic and Cardiovascular Surgery described a preclinical study showing the potential for the investigational small diameter HAV to treat tetralogy of fallow, which is a heart condition that affects 1 in every 2,000 babies born each year. In this large animal study, Humacyte collaborated with researchers From Nationwide Children's Hospital in Columbus, Ohio to implant 3.5 millimeter HAVs into a juvenile model of pediatric heart surgery.

Speaker 2

The 3.5 millimeter HAVs remained patent for up to 6 months and showed evidence of repopulation by host cells, which was similar to what's been observed in human patients. This study also demonstrated the extension of Humacyte's manufacturing platform, adding production of 3.5 millimeter vessels in the same platform that is used to produce Humacyte's 6 millimeter HAVs, which are the ones that are in current clinical use. In July results from a preclinical study on the ability of the HAV to resist infection were published in the Journal of Vascular Surgery Vascular Science. This study provides a scientific basis for the low rates of infection that we've observed in clinical trials of the HAV to date. Researchers found that compared to synthetic grafts, the HAV had a significantly lower bacterial infection rate.

Speaker 2

Disinfection resistance of the HAV may be due to the native like biocompatibility of the HAV material, which supports the survival and function of human immune cells that are the key to fighting bacterial infection. These results have broad implications for all of our intended clinical indications and further support the potential of the HAV as an excellent alternative to Synthetic Graphs in a wide range of medical conditions. And with that, I'll now turn it over to Dale for a review of our financial results and other business developments.

Speaker 3

Thank you, Laura. As of September 30, 2023, we had cash and cash equivalents of $100,000,000 In May 2023, we reported the completion of a funding we have overland capital of up to $160,000,000 of which we have received $40,000,000 to date. Total net cash used was $49,400,000 for 1st 9 months of 2023 compared to $53,800,000 for the 1st 9 months of 2022. We believe that our cash and cash equivalents and expected funding from the Oberland Funding arrangement are adequate to finance operations past the currently anticipated timelines for FDA approval and commercialization of HAB in the vascular trauma indication. There was no revenue for the Q3 of 2023 9 months ended September 30, 2023.

Speaker 3

Revenues were $31,000 for the Q3 of 2022 $1,600,000 for the 9 months ended September 30, 2022. Revenue for 2022 versus related to a grant supporting the development of the HAV. Research and development expenses were $18,600,000 for the Q3 of 2023 compared to $17,300,000 for the Q3 of 2022 and were $56,400,000 for the 9 months ended September 30, 2023 compared to 40 $8,300,000 for the 9 months ended September 30, 2022. The current period increase is resulting primarily from personnel in external services to support expanded research and development initiatives and our clinical trials, including preparation for the HAV, trauma clinical trial end of completion and planned BLA filing for the vascular trauma indication and expansion of clinical development of HIV in AV Access for hemodialysis. General and administrative expenses were $6,100,000 for the Q3 of 2023 compared to $6,200,000 for the Q3 of 2022 we're $17,500,000 for the 9 months ended September 30, 2023 compared to $17,100,000 for the 9 months ended September 30, 2022, the increase during the 9 months ended September 30, 2023 compared to the prior year period resulted primarily from increased personnel costs, largely driven by preparation for the planned U.

Speaker 3

S. Commercial launch of the ATV in the vascular trauma indication. The slight decrease during the Q3 of 2023 compared to 2022 resulted primarily from a reduction in external service due to professional fees, partially offset by an increase in personnel expenses. Other net income or expense the net expense of $1,400,000 for the Q3 of 2023 compared to a net expense of $1,800,000 for the Q3 of 2022 other net expense was $11,800,000 for the 9 months ended September 30, 2023, compared to other net income of $85,500,000 for the 9 months ended September 30, 2022, the decrease in other net expenses for the Q3 of 2023 compared to 2022 resulted primarily from an increase in interest income due to rate increases. The increase in other net expense for the 9 months ending September 30, 2023 compared to 2022 resulted primarily from the non cash remeasurement of the contingent earnout liability associated with the 2021 merger with Alpha Healthcare Acquisition Corp, net loss was 26 dollars 0.0000000 for the Q3 of 2023 compared to $25,300,000 for the Q3 of 2022 a net loss was $85,700,000 for the 9 months ended September 30, 2023, compared to $8,200,000 for the 9 months ended September 30, 2022, the current period increase in net loss results from the non cash measurement of the contingent earn out liability and increased operating expenses described today.

Speaker 3

With that, I'll turn it back over to Laura for concluding remarks.

Speaker 2

Thank you, Dale. This is a very exciting time for Humacyte I'd like to take a moment to thank the entire Humacyte team as well as our partners for their continued commitments to our programs. The entire team has worked incredibly hard to reach this point and we are approaching what could be a transformational time, not only for the company, but for patients who are suffering from a variety of vascular diseases. Across our clinical programs, the HAV has already accumulated more than 1200 patient years of experience, including in vascular trauma, vascular access and hemodialysis and peripheral artery disease. We're also continuing to study the HAV in our earlier stage programs in order to maximize the full potential of the HAV's value for our patients and for our investors, we look forward to keeping you updated on our progress and thank you all for joining us today.

Speaker 2

Operator, we're now ready to take questions.

Operator

Please be prepared to ask your question when prompted. And our first question comes from Suraj Kalia of Oppenheimer. Your line is

Speaker 4

open. Hi, Laura, Dale, can you hear me all right?

Speaker 2

Yes, we can.

Speaker 4

Perfect. Congrats on all the progress. Laura, at Weave, what Additional data on VO5 should we expect?

Speaker 2

At the Veith meeting, we're going to share in addition to the efficacy results, we're going to share some of the safety outcomes. That's during a podium presentation that will occur during the meeting on Wednesday. In addition, on Thursday evening, we have a a dinner symposium session, where we will talk about the VO5 outcomes and also the outcomes from Ukraine And look at the combination of those outcomes and as they compare to our benchmarks in synthetic graft treatment for vascular trauma.

Speaker 5

Got it.

Speaker 4

Post BLA filing for a vascular trauma indication. How should we start thinking about My understanding is the label would be for not indicated for synthetic graphs. So can you size up the market and also the low hanging fruit post approval?

Speaker 2

So I think in terms of the size of the market, as we've shared in earlier presentations, there's approximately 70,000 vascular injuries in the U. S. That occur every year that require some sort of repair And tens of thousands of those probably require grafting or active surgical repair. So of those, about 12% or 15% are done with synthetic grafts. But if you talk to trauma surgeons and if you look at the literature, Essentially, all traumatic injuries are viewed as being contaminated or potentially contaminated and infected.

Speaker 2

So if you again, if you talk to trauma practitioners, they will tell you that synthetic grafts are essentially never indicated in patients with traumatic injury. In addition, we believe that in many cases, the extra hour that it takes to harvest vein It's going to make many patients who might have otherwise gotten a vein, be more suitable for an HAV because the extra hour that it takes to harvest the vein Puts the injured limb at increased risk of amputation. So we believe that we will take a sizable fraction of Certainly, the synthetic graft use, but also we believe will eat into vein use as well In the traumatic injury indication.

Speaker 6

And Suraj, some of the data that may will be presented at this will be the outcome from the study in terms of why surgeons use the HAV in those particular patients and that may provide some further evidence to support what Laura just said about the likely uses and why they would choose to use it in certain instances over synthetic or asafnestane. Got it.

Speaker 4

I appreciate the additional color. Dale, one final question for you. Dale, the contingent earn out in revenue interest liability caught my attention. Love some additional color on I'm assuming the revenue interest liability is the $40,000,000 from Oberlin, but I might be wrong. If you could just walk through

Speaker 3

the Yes, you're exactly

Speaker 6

right. The What we call the RIP or the revenue interest liability is essentially the debt instrument with Oberland. And so that will accrue up over time as interest is accrued. But right now, the face amount of that debt is $40,000,000 the contingent earn out liability is associated with our going public transaction. The legacy holders of Humacyte Our potentially due shares if the stock price hits certain levels.

Speaker 6

And so every quarter, if the price goes down, that liability increases and Non cash expense recorded and if the stock goes down that quarter, there's a non cash gain and the liability goes down.

Speaker 4

Got it. Thank you so much for taking my questions.

Operator

Our next question comes from Josh Jennings of TD Cowen. Your line is open.

Speaker 5

Hi, this is Eric on for Josh. Thanks for taking the question. On the RMAT designation that you have in vascular trauma, I was wondering if you could share with us when you will know whether or not you received priority review for your BLA filing? And secondly, if you do receive priority review, could you specify what that entitles you to throughout the BLA review process? Thank you.

Speaker 2

So as part of the BLA filing, we are going to apply for priority review, which as you may know, would entitle us to a 6 month review period in PDUFA date as opposed to a standard 10 month, Which is more typical for Biologics. So it's my understanding, that once we file That within 60 days, the agency comes back to us with the acceptance of the file, and also with a determination at that time as whether or not they've granted priority review. So I would expect 60 days after we file, we'll know if we have a priority pathway. Again, I would hope and expect that we do because of the RMAT and also because of the priority designation from the Defense Department. The priority review provides a speedier review process.

Speaker 2

I'm not sure That it really changes the amount of interaction you have with the agency. Certainly, once you file a BLA, the amount of interaction and the back and forth and the discussion is always Really robust. So I think it's more about speed.

Speaker 5

Understood. That's great. And then sticking with vascular trauma, with the target you have here submitting the BLA in 4Q, could you tell us what steps remain for the process before you actually make that submission?

Speaker 2

Well, without providing too much detail that we haven't provided already in a public forum, I can say that a BLA is thousands of pages, and that it's a complex document. But I can say that much of the BLA has we've been largely ready for some time. Our module 3, which is really the description of the manufacturing pieces, has been in a fairly final form for many months now, because we transitioned to our commercial stage manufacturing, Actually in 2021. Also our preclinical work is essentially has been done for years And that's module 4. So there are really 5 modules to the BLA.

Speaker 2

I would submit that 2 of them have been done or mostly done for a while. And it's really about wrapping up, the clinical modules And some of the labeling. So we do not anticipate that there will be any difficulties filing this quarter. We see ourselves as Completely on track.

Speaker 5

Understood. Thank you for that and thank you for taking the questions.

Operator

Our next question comes from Matthew O'Brien of Piper Sandler. Your line is open.

Speaker 7

Hi, this is Samantha on for Matt. We just have

Speaker 1

a couple of questions for you.

Speaker 7

I guess, first off, we're wondering if you've Thought about providing humanitarian efforts during this Gaza conflict like you have in the past?

Speaker 2

Yes. That's a very interesting question. I think it's an excellent question. It is a topic that's come up amongst our leadership. In the Ukraine conflict, we had surgeons reach out to us and ask for access to the HAVs as part of treating patients who were injured in the conflict.

Speaker 2

To date, we have not yet received any requests From surgeons in Israel along these same lines. I think it may be that the Israeli healthcare system is Perhaps better equipped, to handle the casualties that they're seeing. I honestly don't know. Certainly, if we had requests come in inbound from surgeons in Israel, we would certainly consider them and work with our regulatory and clinical teams and work with the FDA to consider those requests.

Speaker 7

That's great. Thank you. And then I guess on a I don't know, maybe you could talk a little bit about Launch preparations that are ongoing for the HAV, maybe in terms of hiring sales reps and how you anticipate, launching this product?

Speaker 2

Well, I'll let Dale handle the sales force and part of the launch, but I will say that an ongoing focus for Humacyte and one that where we've made tremendous progress is really speaking to the health economics and the budget impact modeling Of the vessel in the care of trauma patients. It's been incredibly useful that our clinical trial results have shown a real decrease in amputation and in infection as compared to patients who were historically treated with synthetic grafts. That really provides us excellent hard data to make strong economic arguments around the utility of the HAV, not just for improving patient outcomes, but also for improving the total expenditures for hospitals and for insurers. So we're working closely now with our colleagues in health economics that we've brought on a whole team here at Humacyte, really mapping out those arguments and also putting together dossiers that we're going to bring forward to insurers, even in advance of approval to outline for them the size of the clinical problem and the benefits that we think the HAV can bring to patients into the healthcare system. So that's really, in terms of we're doing work on healthy economics reimbursement and also in coding.

Speaker 2

And that's all very active work streams. But I'll let Dale speak to the sales force and the timing on that.

Speaker 6

Yes. Thanks, Lauren. Samantha, as Laura said, much of the effort of the core commercial team right now is geared towards those longer lead As she mentioned, the budget impact model and coding and reimbursement and market access. In terms of the sales force itself, Certainly, there is planning going on in terms of sizing that force and how we would divide up territories and strategies like that. But the actual sales force itself will be brought on will be recruited, but brought on closer to market launch.

Speaker 6

So there's certainly not a need to bring them on so far in advance of the 2024 launch, but certainly the planning is underway right now. As a reminder, this is a very concentrated market we've talked about before where 80 plus percent of the patients tend to be treated at level 1 trauma centers and there's approximately 200 of those centers. So this will be a highly qualified sales force geared towards surgical type products within the trauma setting, but it will not be a huge sales force.

Speaker 7

Great. Thank you.

Operator

And our next question comes from Kristen Kluska of Cantor Fitzgerald. Your line is open. Hi, this is Jason on for Kristen. Thanks for taking our questions. 2 from us.

Operator

Is the surgeon base, how open are they to trying new procedures in options is the first question. And then the second is, just some insight on your plans, if any to collect real world evidence and stats that can help the launch in further years out and I'll take the answers offline. Thank you.

Speaker 2

So yes, those are excellent questions. In the trauma indication, the end users are really going to be a combination of vascular surgeons and trauma surgeons. From the standpoint of both of these types of surgeons, it's true that there hasn't been an important new advance in conduits for vascular restoration and replacement in probably 30 years. So for these practitioners who feel like they've been stuck with the same tools for a very long time, having a new biologic that has as much experience as we now have with over 1200 patient years, I think both vascular surgeons and trauma surgeons find this very exciting. And we are getting just spontaneous questions and comments whenever we're at the podium about when can I get my hands on this, when will it be on the shelf, how fast can I use this?

Speaker 2

So I think there's a lot of anticipation out there in the vascular surgical market. I would also say that for trauma surgeons in particular, They're more trained as general surgeons and not as vascular surgeons per se. And so trauma surgeons by and large Would rather not spend time harvesting vein. It's not something that's really in their wheelhouse. So for trauma surgeons in particular, having a biologic that's Going to resist infection that they can pull off the shelf is I think going to be very attractive.

Speaker 2

As far as real world evidence, Certainly, we're making progress on our coding, so that we can capture cases that are done with the HAV in various we have some scenarios after we're on the market and we certainly plan on continuing to follow that data. I also anticipate that we'll work with some of our key opinion leaders who are who have already been part of our Phase twothree the V05 trial and look at post launch studies of either specific types of injuries or specific geographies and look at usage and outcomes. So I definitely want to take advantage of that after we're on the market.

Operator

Great. Thanks a lot. Our next question comes from Bruce Jackson from The Benchmark Company. Your line is open.

Speaker 3

Hi, congratulations on all of the progress. Most of my questions have been answered. I just you've got the Veith Symposium coming up here shortly. Are there any particular presentations that you're excited about?

Speaker 2

I'm excited about Humacyte's presentations. But I'm also excited about a couple other things that we haven't mentioned. I will Say that there's a surgeon from the Mayo Clinic who's been doing peripheral artery disease work that he's doing an investigator sponsored study with the HAV in patients with critical limb ischemia who are facing potential amputation. So he's going to talk about those results, which are very encouraging. We also have a joint presentation with Fresenius, where we're presenting some early results of a data dive that we're doing to look into the types of patients who have problems with their access, either access failures or frequent access infections to really hone in on which dialysis patients may benefit from the HAV in the long term.

Speaker 3

All right. That's it for me. Thank you.

Operator

And seeing no further questions, I'll turn the call back over to our host.

Speaker 2

Well, thank you very much for everyone for your time and attention. It's been an exciting quarter And everybody at Humacyte is working hard to continue to meet our milestones. As I've said, And I'm just so proud of our team and all the hard work that they've done and also all of our collaborators, whether it's Collaborating surgeons or our corporate partners. So I just want to give a big shout out to everybody who's helped us get this far.

Operator

That concludes today's conference call. Thank you for joining and have a pleasant day.

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Key Takeaways

  • In the Phase 2/3 V05 trial for vascular trauma repair, the human acellular vessel (HAV) showed 90% 30-day patency vs ~81% historical, with amputation rates (9.8% vs >20%) and infection rates (2% vs >8%) less than half those of synthetic grafts, positioning the company to submit a BLA in 4Q.
  • The HAV has also been used under a humanitarian program in Ukraine on 19 war-wounded patients, achieving 100% 30-day limb salvage and survival, 95% patency and zero infections, data that will be included in the BLA submission.
  • Other clinical and preclinical programs include positive Phase 2 results in severe peripheral artery disease for limb salvage, a juvenile heart disease model demonstrating small-caliber HAV patency up to six months, and a Vascular Science study showing significantly lower bacterial infection compared to synthetic grafts.
  • As of September 30, 2023, the company had $100 million in cash plus access to up to $160 million in funding, with R&D and G&A expenses increasing to support expanded trials, BLA preparation and commercial launch, and believes its cash runway extends past anticipated FDA approval and commercialization timelines.
  • Commercial planning is underway with a focus on health economics, coding and reimbursement, and a specialized sales force targeting ~200 Level 1 trauma centers to support a potential 2024 launch of the HAV in vascular trauma.
AI Generated. May Contain Errors.
Earnings Conference Call
Humacyte Q3 2023
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