NervGen Pharma Corp. (NGEN) Earnings Call Transcript & Summary

And there are a number of drugs that have been tested in that as well as stem cells and other biologics and stimulation therapies. So looking at the many, many drug trials that have been tested the non-pharmacologic, this is where the stimulation trials fall and the cellular-based trials. One thing Im pointing out is that very few of these have made it all the way to Phase III. That's the full testing for safety and efficacy. And most of those have been drugs that are repurposed from other disorders. We do have a number of new drugs that are in the pipeline and some cellular therapies, mostly aimed at getting nerve cells to regrow again, sometimes aimed at blocking the things that are inhibiting them from growing and sometimes aimed at specific functional outcomes. With all of those many trials that have been run over the last 25 years, we have a number of take-home points. One is that we have to have a realistic goal of how much recovery is going to be necessary to call the drug effective and beneficial. A lot of the trials are based on very realistic targets and very unrealistic goals of how much improvement the community would see. The other, as I mentioned before, is we have to combine our drugs and cells with rehabilitation, and we can do that. I'm listing one trial here that proved that we could do a multisite coordinated rehabilitation trial. And in terms of looking at those outcomes, they need to be clinically meaningful, not just a neurological change in the single muscle, but something -- and this is what we need to hear from the community about. The early fampridine formulation, it was a 4-aminopyridine trial actually worked with the FDA to develop an outcome measure that had both of these components. So why have so few of the drugs that have been tested gone beyond the Phase II early efficacy kind of data? Lots of reasons in terms of timing and dosing and whether or not they needed a combination. But I think the biggest question is, did we treat the right people at the right time after their injury and how much benefit did those people hope for from that treatment. Now that's a very important question, and we're here to discuss it. But often trials are driven by how much benefit the sponsors of those trials are looking for, whether they're willing to invest in that larger expensive Phase III trial. We have a few sponsors and an incredibly important recent success in our field where noninvasive spinal cord injury stimulation has been approved by CDRH for an SCI indication for hand function. And I can't overemphasize the importance of this. It's just great. But there are a lot of autonomic benefits that we know are really important to the spinal cord community, and they're called secondary outcomes. And if you use stimulation for those, you are still off label according to the current approvals. So as I said, there are way too many trials for me to list and talk about each one, but there are a couple of websites I can direct you to where you can look them up. As you can see here, there are hundreds of trials listed on some of these sites. This is curated by clinicians and researchers. This is a site that's driven by the spinal cord community itself, looking at all the different types of techniques being tested. Spinal cord injury has a lot going for it. We have strong animal models. We know when the injury starts. We can move from rodents into larger animals, and we have really good outcome measures, both for movement, autonomic, all those important functions. We have one of the very few disorder-specific designated repositories for our data, which is really important these days so that we can make the data public and share it. We have really good outcome measures for our clinical trials, and we're one of the first disorders listed on the NINDS common data element site. And there's a site called, SCIRE which is essentially encyclopedia of how to do all of these measures well. And I want to emphasize that using measures developed for other kinds of disorders is not always appropriate for spinal cord injury. So when we get to patient-reported outcomes, we have specific validated outcomes for quality of life and function in spinal cord injury. The other thing that's happening within the research community is discussions of how to run smarter trials, get the right people in the right trials at the right times and how to use that natural history data for historical controls or synthetic control groups. So I want to end with just talking about some of the challenges to developing treatments. The biggest one, and you'll hear it over and over from people and from the researchers is that it's a tremendously heterogeneous issue. It's a whole body issue, as I said before. People have different severities of injury. They're at different parts of their spinal cord, recovery times, medical history. And that leads us to -- you don't want people in a trial that so much function, they have nothing left to really gain that you can measure. And the floor effect is if a person is so severely injured that the tissue that, that drug is supposed to help is no longer there. The other important thing is it's not a large community available for these trials. So I said we have great animal models. No one model is enough to jump from an animal into a human. We need to use them realistically. Each one has a particular value for predicting whether or not it's safe and effective to try in a person. We need to work with our spinal cord injury community and with the FDA to get clearer agreement on what a clinically meaningful outcome would be for a trial. And because of the nature of this injury as a whole body injury, no one measure is going to really report everything that is important to the community. And I'd love to hear more from the community about how to build outcomes that really get all the benefits that they may see from a particular trial. The community needs to -- the researchers need to develop better biomarkers, both for prognosis, telling people what kind of natural recovery they might have and also for trials. And I'll end by referring back to polypharmacy. As I think we'll hear from the community, many, many drugs in a lifetime complicates lives, but it also complicates trials. On the other hand, what we've been doing in the past, which is using treatments off-label in spinal cord community is just not good enough. We need to go all the way through the phases of the FDA trials to get indications for specific benefits for spinal cord injury. So with that, I want to thank you. I'm really honored to be part of this exciting effort. I'm going to send it back to the studio and very much looking forward to seeing what our SCI community partners are going to tell us about their experiences. Thank you.

Thank you so much, Dr. Kleitman. It's now my pleasure to introduce our second topic for today, session 2, which is all about treatments both current and future treatments for spinal cord injury. I'd like to share with you some of the questions that we will be exploring together as we try to understand these different experiences. So as part of this afternoon, we want to hear your voices sharing what you are currently doing to try to treat or manage your loved one's spinal cord injury. Within the scope of what we might call treatments or management strategies, we very much are casting a wide net. We want to hear not only about medications, including off-label use of medications and medications for particular secondary issues and consequences of spinal cord injury, but also a broader range of things, whether that's mobility assistance devices and other medical devices, different therapy that you or your loved one might be participating in, but also more holistic approaches and even things that you're doing in day-to-day life, anything that someone is doing to try to make living life with spinal cord injury a little bit easier, counts as a treatment even if it's a lifestyle modification. So again, what are you currently doing to try to treat or manage spinal cord injury? Amongst those things, we want to know how well do they treat the most significant symptoms and health effects of spinal cord injury as well as how has you or your loved ones treatment regimen changed over time. So we'd like to hear about things that you've tried in the past and how that has led to what you're currently doing now. We know that no treatment does not come without some trade-off or downside. So we want to know which are the most significant of those downsides to your or your loved one's current treatments and how do those downsides, whether side effects or burdens of keeping up with a particular approach affecting daily life. We also, within the scope of this discussion, are interested in your experiences with investigational products as part of clinical trials or expanded access and so -- as well as your interest in participating in clinical trials. So we want to know what factors would be important in deciding whether to participate in a new trial. And kind of the ultimate question as part of this session is we want to know short of a complete cure, what specific things would you or your loved one be looking for in an ideal future treatment for spinal cord injury. We all would love that complete cure, but we need to know what's important to you before we get to that point. So we hope you'll weigh in on that as well. To get us started on this topic, we have our second panel of the day. We have Susie, Nancy, Jesse, Matthew and Jennifer and Walt. Susie, why don't you get us started?

Hi there. My name is Susie Scherb. I'm from Minooka, Illinois. And our son, Clay suffered a C5 spinal cord injury from a shallow water dive accident in 2022 during that summer when he was 17 years old. One minute Clay was busy writing college applications and playing lacrosse and the next minute, his life was shattered. Very soon after Clay's injury, we learned about the NervGen clinical trial. And from that moment on, Clay wanted nothing more than to try to qualify. And so when they started recruiting, he was there. He failed the first screening and a few weeks later, he came back and he nearly failed again because he simply could not initiate a step without body weight on the parallel bars. But his therapist offered him to try on the EvoWalk, and that's where he passed and he became patient #2 in the trial. 8 weeks later into the trial, I was sitting in the gym with my camera and his therapist asked if he wanted to try the parallel bars again. And what happened next, I will never forget, Clay got on the parallel bars and he initiated a step and then he took another step, another step and then he walked across the parallel bars. It was unbelievable. He had no support from a harness except for safety and his therapist hadn't helped him whatsoever. And it was really from that day forward from what we saw on the parallel bars with Clay that our hope for his recovery has not wavered. We also witnessed other changes in clay in his tone and spasticity before the trial, transferring Clay from his wheelchair into the car could take several minutes just because of the strong tone that his leg had. And so in the Chicago winter months, when it's freezing out, his legs would not cooperate and it could take several minutes before he would be able to safely get into his seat from his wheelchair. It's another to know that, that meant like Clay could take Ubers with his friends because he wasn't horrified by his legs and the tone of his legs not cooperating. He could go to parties and socialize because he could transfer from his chair to his couch without being embarrassed of what his legs would do when they weren't cooperating. It was life-changing for Clay, spasticity, just tone. It's a big deal. Clay only could place 1 peg on in the -- during the 9-hole peg test, he could only place 1 peg into the peg board with one hand, and he couldn't do any more. And then on his left hand, he couldn't do any at the beginning. By the end of the trial, he could place all 9 pegs in and out of the peg board within 2.5 minutes with both hands. And while these numbers are impressive, that's not the important part. Clay was about to start college, and he did not want to go to college using his power chair. And after the trial, because of all the improvements in his arm and hand function, he was able to propel a manual wheelchair with power-assist wheels, and he did not have to drive his power chair anymore with a joystick. It was like it was -- this change meant so much to Clay. And because he was in his manual chair, he could join a fraternity because a lot of the fraternity houses don't have ramps and he needs to be picked up and carried into fraternity houses or up the second flight of steps or wherever they were carrying him. And it really opened up a whole social life for him, just being able to have enough dexterity to push that wheelchair. So nearly a year after Clay completed the trial, one of his research doctors drew a hockey stick on the whiteboard. And they pointed it to it and said, this is what Clay's recovery looked like during the trial. And it was a hockey stick like this. And they explained that the long handle of the hockey stick represented the early weeks of his trial, slow and steady progress. Then about week 8, the line shot up where the blade of the hockey stick is. And his progress wasn't slowing down. It appeared to be like suddenly accelerating. Clay was only on NVG-291 for 90 days. And to this day, we still ask ourselves the same question. What would his recovery have looked like if he had been able to stay on the drug longer? A year, 6 months, 2 years permanently, I don't know, but nobody knows what his recovery would have been. But we do have a lot of hope because of what we saw. If you remember nothing else that I've shared, please remember the drawing of the hockey stick that his doctor made on that whiteboard and give everyone suffering from a spinal cord injury an opportunity to experience the same hope for recovery that Clay got. Thank you.

I'm Nancy Hansen, 69 years old and live in Rockaway Beach, New York. A little more than a decade ago, my life changed in an instant. A minor automobile accident resulted in an incomplete C5/6 tetraplegic spinal cord injury. The medical team advised me to prepare for life in a wheelchair with limited mobility and a handful of medications. I respected their medical expertise, but I was not willing to accept that prognosis to define the rest of my life. At the time, I was 2 years shy of turning 60. My 5 children were in college or living independently. I've been a successful entrepreneur, traveled throughout the United States and visited many countries. I felt I lived a life far greater than any Bazooka bubble gum fortune offered me. But there was one experience I had never faced, recovering from quadriplegia. Others saw what I can't do. I chose to see what can I do if I try. Well, together with my physician, we developed an intensive rehabilitation plan. With his support, I committed myself to daily physical, occupational aquatic and massage therapies. I also explored craniosacral, acupuncture, self-hypnosis, tai chi and other rehabilitation techniques. Those 60- to 90-minute therapy sections became my full-time job. I believed if I committed myself completely, my payment would come in the form of whatever recovery my body was capable of achieving, even if progress came one small step at a time. Under medical guidance, I worked to reduce those multiple medications. Pain relievers, muscle relaxant and sleep aids caused me drowsiness, fatigue, dry mouth, constipation and depression. I wanted to understand what my body could do without adding unnecessary obstacles. My philosophy was simple. If I could feel something, something in my nervous system was still communicating. I learned not to fear every sensation, but to understand it, manage it or accept it. I still wake with neuropathic burning in my feet, spend all day with it and then go to sleep with it. But I did learn the less energy I feed it, the less power it has over me. My therapist challenged and encouraged me, introducing me to new rehabilitation techniques, equipment and technologies. I intentionally surrounded myself with professionals who believed improvement could continue long after 1 or 2 years. I celebrated 1-year milestones, buttoning a shirt and zipping a zipper, standing with assistance and gaining control over muscles. I have not been able to control. But I never considered those accomplishments the finish line. My journey was interrupted by an unexpected and devastating loss of my husband. His unconditional love made me forget that I even had a disability. He encouraged me to snow ski, try indoor rock climbing and even soar again in a glider. With him, I feel whole. Well, only a few months after his death, COVID-19 brought rehabilitation to an abrupt halt. Therapy centers closed, isolation replaced human connection. Because of my medical diagnosis, my children were afraid to come near me. My body began to regress, muscles atrophied, UTIs became common again, tone and spasticity became more often and fatigue controlled my daily life. Some of the most meaningful improvements, however, occurred 6 or 7 years after my injury. Participating in SCI-FIT, a program for spinal cord injured and neurologically impaired. My core muscles and weight-bearing standing improved. My intercostal muscles became strong enough for me to cough again. And breathing exercises strengthened my diaphragm and gave my abdominal organs room, allowing me to eat an entire slice of pizza. My bowel accidents became less frequent, bladder function became more predictable and nearly 8 years after my injury, my sweat glands began working again. I know these sound like small victories to some, yet to me, they represent health, freedom and dignity. My experience taught me that the spinal cord injury is catastrophic, but recovery does not necessarily end after 1 or 2 years. At least in my case, my nervous system continues to adapt when I challenge it. I ask the FDA to recognize the importance of meaningful and functional improvement when evaluating new technology and devices, being able to stand longer, ability to cough, moving our hands, predictable bowel and bladder function, these matter. And yes, being able to eat a slice of pizza, it really matters. These are measures of independence and quality of life. I've been working for more than a decade. I'm not yet finished. I'll keep challenging my body for as long as it's capable of changing. My goal is still to run a mile again. Thank you.

For the first 5 years after I broke my neck, nearly every version of recovery that I pictured included walking. It's what everyone asked about. It's what I was looking for in therapy, and it's what I pictured when I thought about getting my life back. My name is Jesse. I am 41. I live in Washington State, and I have been an incomplete quadriplegic since a C3/C4 spinal cord injury in 2012. 5 years into my injury, I understood recovery very differently. Walking still mattered to me. But by then, I knew how much of my day was shaped by my hands. Nearly every ordinary task required extra time or help. My impaired hand function was and still is the most frustrating part of my injury. In 2018, I joined a clinical trial at the University of Washington, studying transcutaneous stimulation of the spinal cord for upper body mobility. My study was part of the early research that eventually became part of the Up-LIFT pivotal trial. The study required a 6-month commitment with baseline testing and occupational therapy with and without spinal stimulation. Participation required 6 or more hours per visit, several days a week. That time included transportation, setting up the technology, testing and receiving stimulation during occupational therapy. The possibility of greater independence mattered enough to me that I was willing to accept potential pain muscle spasms, autonomic dysreflexia and the unknown long-term effects of the spinal stimulation and the significant time commitment. I was fortunate enough to live within an hour of a major research hospital and have the flexibility in caregiving support that I needed to participate. Having the option to complete even some of these sessions at home would have made the commitment a bit easier to manage. I could not put my hair in a pony tail before the trial. I still cannot put my hair in a pony tail, but I can get closer. That might not sound impressive until you understand that my recovery with an incomplete spinal cord injury just lives in that space. It makes a better story when things divide neatly into what I could do before and what I can do after, but that's just not my experience. It may be meaningful to tell you that my pinch grasp improved by 18%, but I do not spend my days pinching a metal gauge. What I can tell you is that it felt like my life was 5% or 10% easier. And I know that's not a clinical measurement, but it is the difference that I experienced moving throughout my day. My hands became more reliable. I had fewer bad hand days when spasticity pulls them tightly into fists. I trusted my hands enough to attempt opening jars or using scissors. And that growing willingness is how I picked up a paint brush and started painting after all those years for the first time since my accident. Before the study, I received around 16 hours of caregiving each week. Afterwards, I felt confident enough to buy my own home and live alone while also reducing my caregiving to about 8 hours a week, which meant that I could put my shoes on in the morning, prepare meals, use the restroom independently and safely and get myself changed and ready for bed in a timely manner. The study focused on my arms and my hands, but I experienced changes throughout my body. I have less spasticity, better bowel and bladder function, improved temperature regulation, better sleep, greater core strength and those improvements remained 7 years later. During the month of stimulation, I experienced a temporary increase in nerve pain and muscle fatigue that did resolve afterwards and was not surprising to me knowing that I was stimulating neural pathways and retraining muscles. Hand function matters enough to me that I would consider another clinical trial even if the treatment carried meaningful risk. Disabled people are often treated as though protection should override choice. Give me accurate information about the risks and potential benefits and let me choose. Regaining even a small amount of function changed nearly every part of my life.

Hello. My name is Matt. I'm 48 years old, and I live in Monroe Township, New Jersey with my wife Jen and our 2 daughters, Hannah, who's 13 and Abbey, who's 11. I'm a father, a husband and a supply chain executive. Five years ago, an ordinary drive to work changed my life. A seemingly minor car accident left me paralyzed from the waist down with T11/T12 incomplete spinal cord injury. This means my spinal cord was severely damaged, but some nerve signals were still able to get through. At the time, I had no strength, no movement and no sensation below my waist. For nearly 3 years, I relied on a wheelchair. Today, I walk with forearm crutches or a rollator. That didn't happen simply because time passed. Recovery became a long-term commitment that continues today. My treatment has included specialized neuro rehabilitation, daily exercise, 4 clinical trials, robotic technologies, evolving orthotics and an off-label medication intended for people with MS that has dramatically improved my balance and endurance. Not everything has worked, but each experience has shaped the next step.

What people see today is Matt walking. What they don't see is everything that has taken to get here. Our entire family organizes our lives around recovery. We've transformed part of our home into a rehab gym, driven thousands of miles for treatment and invested enormous financial resources into care that insurance just doesn't cover. We know how fortunate we are to have been able to prioritize Matt's recovery, and we know that many families simply cannot. Recently, Matt lived in Boston for 6 weeks for a clinical trial combining intermittent hypoxia, noninvasive spinal stimulation and intensive gait training. While he worked full time and received daily treatment, I stayed home in New Jersey working and caring for our girls and our responsibilities at home. Time and time again, our girls have repeatedly lived without one or both parents while we pursue treatment. Participating in treatment doesn't happen alongside life. It often competes with it. And I don't want Matt's progress to be mistaken for resolution. We've gotten very good at building our lives around spinal cord injury, but that doesn't mean it stopped limiting our lives. Before Matt's injury, travel was a huge part of who we were as a family. We traveled around the world together. We still travel, but now every trip requires us to think about accessibility, distance, terrain, transportation and how much energy Matt will have left when we get there.

I recognize how fortunate I've been to have access to rehabilitation, research, technology, resources and family support. And even with all of that, I'm still pursuing recovery 5 years later. I participated in 4 clinical trials involving intermittent hypoxia, noninvasive spinal stimulation and robotic orthotics. Some trials produce gains immediately and others over time. But those improvements have become building blocks for continued recovery. The C-Brace trial changed the trajectory of my recovery by getting me up right and walking. While my left side remains significantly more impaired than my right, the C-Brace allowed me to stand and to begin strengthening the connections on my right. Research has changed what I believe is possible. But none of these interventions have restored what my injury took away. Last month, I lost my mother. I wanted to be one of her pallbearers, but I couldn't. Even at her funeral, instead of simply grieving, part of my attention was on my body, where I needed to walk, whether I could manage it, where I could sit and how much energy I had left. That's what mobility means to me. It's not simply whether I can take steps. It's how much effort those steps require and how much of my life is organized around that effort. I still work full time. I'm still raising my daughters, I still travel with my family. But I do all of those things while constantly calculating what my body can manage.

Living with spinal cord injury has also changed how we think about risk of trials. In considering research opportunities, we wouldn't accept a substantial likelihood of Matt losing the function that he's fought so hard to regain for only a remote possibility of improvement. But we are willing to accept uncertainty and meaningful risk for a real opportunity to gain function.

Meaningful recovery also looks different for everybody. For one person, it may be improved hand function for another better bowel and bladder function. For me, it's walking. I can walk, but I still need assisted devices, I still need concentration, and I still need both hands for support. I can't stand in the shower, I can't run. I can't carry something while I walk and I can't dance with my wife. Before my injury, I ran marathons. I'd love to run again, but a treatment doesn't have to get me back to running marathons to change my life. Walking without a device, standing safely in the shower, carrying something while I walk, dancing with my wife, those would all be meaningful recovery. What may look like small clinical improvement can mean enormous change in independence and quality of life. We've learned how to adapt our lives to spinal cord injury. What we need are treatments that allow us to adapt less.

My name is Walt. I'm a 40-year-old process engineer living near Columbus, Ohio. I have a T5 complete spinal cord injury, which means I'm paralyzed from the chest down. My life at 38 had really hit its stride. I have been working towards and finally received a promotion about a year earlier that made things a lot more comfortable financially. And increased my responsibility dramatically. And with the promotion, I found myself traveling all over the U.S. and Europe. When I wasn't working, I spent my evenings in the garage working on ATVs and dirt bikes. I raced National Enduro, Grand National Cross Country series events all over the country as well as Ohio Cross-country racing series events whenever I could. The last few years before my injury, I raced over 20 events a year on average from Florida to New York and as far west as Texas. When I wasn't doing those things, I was taking trips ride dirt bikes with friends and family or mountain biking or hiking with my partner. I never sat, I seldom slept, and I was one of the most positive people you could hope to meet. I was injured in April of 2024 on the last day of a fantastic week of technical riding in the desert of Utah with my dad and some friends. A simple and uncharacteristic mistake on a loose gravel road saw me leave the road around 30 miles an hour. I hit a ditch and flipped over the bar wearing every imaginable piece of safety equipment I landed, fracturing my pelvis and my T7. I was taken by helicopter at St. Mary's Hospital in Grand Junction, Colorado, where they repaired my pelvis and then performed surgery to stabilize my spine 2 days later. Unfortunately, the damage was done. Next, I went to Craig Hospital in Englewood, Colorado for inpatient rehab. I worked remotely in the evenings, the whole way through rehab desperate to retain the job I worked so hard for. The outpouring of support from my employer, my family and the racing community was amazing. By the time I got home, my friends and family had converted my first floor to be fully accessible, widening doorways, redoing the deck and the floors and installing a ramp on the front porch and lift on the back. I quickly set to work to establish some sort of a routine. I was already driving and quickly purchased a standing frame and a used FES cycle to try to keep my legs in shape, hoping for some innovation to help me use them again someday. In November of 2024, I moved to New Jersey for nearly a year to take part in a clinical trial aimed at using an epidural stimulator to implant to restore function below the injury. After a few weeks of what they call mapping, where we perform a lot of tests to try to identify the best stimulation settings, the folks at Kessler and I work together in the clinic for an hour each day, alternating between standing and stepping using the stimulator to improve the communication in my damaged spinal cord to allow me to volitionally move my legs again. To date, I've managed to stand unsupported for 1.5 minutes with only a bar to hold on to for balance, and I can take steps with a weight-assisted treadmill. It isn't really functional yet in my day-to-day life, but I'm still working hard on it. And though it is remarkable to be able to do these things at all after a complete spinal cord injury. Since moving back to Ohio in September of 2025, I've continued to work on standing and stepping with the physical therapy staff at OSU. In my first follow-up appointment 6 months after the trial ended, the folks at Kessler were surprised and encouraged to find that I have actually improved since I left. My PT at OSU has also identified several areas where the work we're doing appears to be benefiting me compared to typical complete thoracic injury. Our weekly standing and stepping sessions put weight through my legs to keep my bone strong. Using the muscles keeps them from atrophying, which also prevent pressure sores and my core control has continued to improve. I live around an hour from both my office and OSU. It takes me almost 3 hours from the time my alarm was off to be ready to go out the door and the loss of bowel and bladder control that comes with the complete spinal cord injury is a constant source of stress and anxiety. Once I was back home, I started going to the office twice a week and working remotely for the other 3 days. This ultimately led me to obtain a small apartment a few miles from the office, which helps me get to work and PT on time and gives me some place to go in the case of bowel and bladder issues during the workday. I'm surprisingly independent getting out of my injury. Everyone seems impressed with how well I get along, but the reality is with the effort I put into my life, both before and since the injury, the quality of life I've been left with simply isn't good enough. I was a world traveler usually at the drop of a hat and now concern over bowel and bladder incontinence means I won't get on an airplane and even simple road trips require careful planning and problem solving. A loss of control and sensation related to bowel, bladder and sexual function are the most significant quality of life impacts that come with the spinal cord injury. While working to restore volitional movement at the Kessler Foundation, I also had a chance to participate in a trial where I received a portable ultrasound device to calculate the volume of fluid in my bladder to let me know when I need a cath. The impact of such a simple device on my life in terms of avoiding bladder accidents has been amazing. The truth is I've lost so much as a result of this horrible condition that even the restoration of things that might seem to be insignificant for an able-bodied person is likely to have a huge impact on my life. I personally had a chance to participate in some groundbreaking work that has had a positive impact for me, and the field appears to be accelerating significantly. There are so many promising interventions on the horizon. We need to approach functional restoration after spinal cord injury with a sense of urgency.

Thank you, Walt, and to all of our panelists for starting this discussion about how this community navigates treatments and management strategies for spinal cord injury and also starting that discussion around what you're looking for from future treatment. It's now our second opportunity today to broaden the discussion to all of you in our live audience, people living with spinal cord injury and their caregivers. If you would like to share some of your treatment experiences to date, we welcome you to call in now and throughout this afternoon's program. You can do so by dialing 1 (703)-844-3231. Again, that's 1 (703)-844-3231. And again, when you call in, you'll be connected with our operator who will take some information down and allow you to then be brought into the program. You can also submit written comments now and throughout the program, sharing your treatment experiences by using that comment form under the player on the web page you're following along today. But to get us started in exploring this topic around current treatment approaches and management strategies, we'll have a few polling questions for you to kick things off. So if you're with us before, you can open up that web page. If you've joined us and you're a person living with spinal cord injury or a caregiver, these questions are for you. This is -- if you can go to www.pollev.com/scipfdd. Again, that's www.pollev.com/scipfdd. keep this web page up throughout the afternoon. Any time a new question comes -- we go to a new question, it will automatically appear. Our first question for you this afternoon is we want to know what medications have you or your loved one used to try to treat symptoms associated with spinal cord injury, and you can select all that apply. This question is focused on medication specifically. The options are: a, muscle relaxant, Botox or other anti-spasticity medications; b, neuropathic or chronic pain medications; c, bladder-related medications; d, bowel-related medications; e, blood pressure medications; f, antibiotics for recurrent UTIs or other infections; g, medications for anxiety or depression; h, off-label medications used to support recovery or function; i, an investigational medicine in a clinical trial; j, some other medication that is not otherwise listed in the other options; or k, not applicable because you or your loved one have not used any medications for your spinal cord injury and associated symptoms. And as a reminder, for these questions where we see -- allow our audience to select more than one response, those percentages you're seeing are not a percentage of individual people who have made the selection. It's a percentage of overall results. So the best way to look at these questions is the orange bars are kind of relative rankings. So as it stands, it looks like some -- the greatest medication being reported by our audience being used are bowel-related medications. After that, we see antibiotics for recurrent UTIs and other infections as well as muscle relaxant, BOTOX and other anti-spasticity medications and neuropathic or chronic pain meds. And then finally, bladder-related medications, although we do have experience across the board with all the different categories of medications here, including off-label meds, investigational meds and others that weren't listed with a small number of individuals saying that this is not applicable because they're not using any medication. So thank you. We can move to the next polling question here. So moving beyond medications into other types of treatment approaches, which we do want to hear about. We want to know have you or your loved one, which of these have you or your loved one used to help manage spinal cord injury-related symptoms. Again, you can select all that apply. Options are: a, physical therapy, neuro rehabilitation or structured exercise; b, occupational therapy; c, speech therapy, communication aids or voice amplification; d, bowel or bladder management; e, respiratory support; f, mobility equipment; g, home modifications and adaptive equipment; h, electrical stimulation; i, fertility treatments or reproductive assistance; j, caregiver home health aids or other personal care attendant or support; or k, something else that hasn't been listed here on this slide or the previous one that you or your loved one have used to try to help manage spinal cord injury-related symptoms. And then you can choose l not applicable if you're not using anything. So we'll give you a few moments here to get your responses in, let us know all the different treatment approaches you've used. As it stands, it looks like some of the top most reported are mobility equipment and physical therapy, neuro rehab and structured exercise. Closely following that, we have home modifications in adaptive equipment and electrical stimulation as well as bowel and bladder management. But again, we see a wide range of different approaches here, including some others that we did not have listed being reported by our audience. If we go to our next polling question. So we talked about different treatment strategies. One thing that is we're interested in is whether or not you've participated in clinical trials because we know when there are unmet needs, often people go to clinical trials to help get potential access to treatments that may be helpful to them. And so what we'd like to know here is, have you or your loved one participated in or attempted to enroll in a trial for an investigational spinal cord injury treatment. The options are: a, yes, and I enrolled in one or more clinical trials; b, yes, I attempted but was excluded from a trial; c, I have not attempted but have considered enrolling; d, I'm not currently interested in participating in the trial; or e, I've not been aware of clinical trials for spinal cord injury. Just give a couple more moments here to make sure everyone has a chance to log their answer. We do have a high rate of clinical trial participants represented in our audience, about half the audience, the person with spinal cord injury or their -- whether themselves or their loved one have enrolled in trials. We see about 20% who wanted to enroll and attempted to, but were excluded and about 20% who have not attempted but are considering it. So a high degree of interest, including people who have been successful and others who have not. But about importantly, I think, 10% of people not being aware of clinical trials for spinal cord injury. One final polling question here before we jump into the live discussion. So thinking about all of these things, medications and other non-medication treatment approaches, we wanted your assessment of how well does you or your loved one's current treatment regimen control symptoms and support daily function overall. the options here are a, not at all; b, very little; c, somewhat; d, to a greater extent; or e, not applicable because you or your loved one are not using anything. As you're making these selections, I want you to think about what drove you to making your particular selection for what looks like about 60% of our audience are saying somewhat, where have things been somewhat helpful and where have they not? Which things in particular were you thinking about when you made that selection. Same goes for about the 20% of you that are saying very little, both where has the very little been, but of course, what has not been helpful. We see about 15% of you saying to a great extent. So we certainly want to hear about those experiences as well. And we see about 5% saying not at all with only a few reporting not applicable because they're not using anything. So thank you for giving us a sense of some of your treatment experiences and kind of a high-level understanding of your overall assessment of how well those are working. We want to explore those deeper now with the audience discussion. And so to get us kicked off on that, I'd like to welcome our Zoom panel, some of your peers in the community who will be helping weigh in on some of these questions. And maybe we can start with you, Anita. What I'd like to do maybe first, we saw that different people reported different degrees of overall success with the current treatment regimen. But maybe think about those things that have been most helpful even if in small ways, what has that looked like for you?

James, thanks. So I am Anita. I live in Toronto, Canada. I'm 54 years old, and I've been living with spinal cord injury for 30 years now, I'm the C6/C7 ASIA A from a motor vehicle collision. And so to answer your question, I think the things that probably help me the most, and I fell into that somewhat category because I'd say there's sort of temporary fixes. So if I think about pharmacological treatments, it would be things like antibiotics to treat like acute bladder infections or UTIs and probably bone drugs because they help reduce the rate of loss of my bone health, although I say it's temporary because as I age with the spinal cord injury, especially when I hit menopause, there was a sharp decline. about 10% bone loss within 1 year, and I got a fracture. And so I ended up having to switch from one medication to another. And I feel like I found with most treatments, they're temporary. They're sort of a bandage solution that works for a bit, but then either you need to switch to something else or with aging with the spinal cord injury, they're no longer effective and you need to look for something else.

Yes. So maybe since you mentioned kind of slowing the progression of bone loss, just to explore your experience there a little bit more, have you -- have the things that worked initially continue to work? You mentioned a little bit as with aging, some things maybe work less. Can you just kind of help us explore like what that's looked like and also what that flowing of bone loss has meant to you?

Yes. So bone loss is an interesting one because osteoporosis is considered one of those silent conditions. You don't know that is an issue until you get a fracture. So it's really, I'd say, more about prevention more than anything else, right? It's trying -- you lose a significant amount of bone within the first couple of years, and then it's a gradual decline over the years. And then again, another significant drop when you hit menopause. So unfortunately, I didn't get on the bone drug until after that initial time point. So I already experienced a significant loss, and I was already in a moderately to high-risk group for experiencing a fracture. So it was really about trying to maintain and hopefully improve my bone strength through the combination of drugs with therapy. And so I managed for several years to reduce the extent of bone loss quite substantially and keep it very stable until like I said, till i get a menopause. But one of the things I want to talk about that's more related to the bladder part is that we've heard everyone talking from the morning about all the different secondary complications, but I don't think we really talked about how interconnected they are and also regarding medications and treatments, the ripple effect it has because often what happens is you take a medication or you do a treatment depict one thing, but then it creates a number of other issues that you then have to try and deal with.

Can you share?

[indiscernible] Cycle...

Yes. So Anita, can you share an example, like maybe something you've gone through that has had that ripple effect?

Yes. So I can talk about my bladder because that's probably one of the biggest issues I've dealt with. So when I was first injured, I had a high-pressure bladder that was causing back into the -- urine back into the kidney and causing distension. So within a year after my injury, I ended up getting a surgery to augment my bladder and also they created a passage to go up to my belly button, but they use a piece of my bowel in order to enlarge the bladder. So that made a huge difference to my bladder because now I was able to cath independently on my own, which is fantastic. It also reduced the number of urinary tract infections I was getting. However, my bowel treatment changed from going 3 times a week or every other day to now daily. So it made that big difference. Also because of the staples, I started getting bladder stones because stones were growing on the staples. Eventually, like I said, I worked periodically for a period of time, but I started getting more bladder infections. And so antibiotic use over 30 years, you start getting resistance to some antibiotics. I started getting more stones and bacteria grows on the stones. So that caused more antibiotic use. And then there's a whole thing of drink a lot trying to prevent infections, but that means you're catheterizing more. That introduces more bacteria, so it makes you more prone to infections. So this is why saying like there's this cycle that occurs. The heavy antibiotic use causes gut health problems. Now you're dealing with bowel issues as a result of it. So...

No, that's super helpful.