Vyome Holdings, Inc. Common Stock Chardan's 10th Annual Healthcare Conference

Yeah. A quick background about myself. I'm an MBA with more than 30 years of operating experience in pharma biotech. Thanks Steven, and thanks for this opportunity. Quickly to summarize in three bullets about Vyome. One is we focus on those programs where there's a big unmet need or there are no FDA-approved therapies with a smarter clinical development so that it is absolutely capital efficient. The second aspect is we actually manage lean operations with significant capital efficiency, and the third is a clean capital structure in terms of the way we manage our capital, which is simple common stock.

Hi, I'm Shiladitya Sengupta. I'm a professor of medicine at Harvard Medical School and founder of Vyome. I love developing drugs, and that's the reason why we started Vyome. I work on inflammation. I've been working on this beat for more than 25 years now, taking drugs to clinics. At Vyome, what we are trying to do is take existing drugs, figure out unmet clinical needs in patients, and position them based on mechanisms to address those needs. Known risks of existing drugs and unmet needs of patients. That's the bridge that we do. That's what Vyome is about.

Yeah. I think the first and foremost philosophy is that we manage lean operations. We obviously need everything that is required for a public company operations. We leverage the Indian scientific as well as cost advantages in developing drugs, including a lot of backend support work to CxO team here. We use specialist consultants since we are in potentially orphan drug indications who actually work on various aspects with FDA requirements. That is how we manage our hyper cost-efficient operations.

Yeah. The drug has been tested on almost 450 patients. I mean, over 400 patients at least, and had a pretty clean safety profile. That basically at least gives me a lot of comfort as we are developing the drug. It sets the baseline for the safety that we can expect. The goal is to test it out in clinics in malignant fungating wound, and it is the efficacy endpoint that becomes more important. Safety is less of a concern for me now, given all that data that exists. We are trying to minimize the risk and then focus on the efficacy right now.

Yeah. Malignant fungating wound is a rare indication. Okay? It happens in about 10% of advanced cancer patients, so very typical in breast cancer, for example, or head and neck cancer. What happens is the cancer breaks through the skin in the last stages of the patient. It's a horrible condition for anybody who's not seen this. Because the tumor is growing out, it cuts off all the blood supply, so there is a lot of exudates, like pus formation. There's a lot of infection in that area. It smells so bad that you cannot actually enter the ward, the room or the ward where the patient is in. Okay? Imagine you're caring for a loved one who has this, you can't enter the room.

Impact on the patient is horrible, so they go into psychological depression, and this is happening in the last 6 to 10 months or 12 months of their life. If you can actually treat the symptoms that these patients are going through, you transform their lives, and that's what we wanted to do. That's been our goal. Venkat talked about cost efficiency. It's also the fact because we have it's a rare indication that the pilot study that we did, the data is pretty compelling. That basically helps us make a cost-efficient clinical trial. This is what the disease is basically, that's what we're treating.

Yeah. This was a pilot phase II study. Patients basically had severe form of malignant fungating wound, malodorous malignant fungating wound. You could actually smell it almost 10 feet away, with full dressings on. And in those patients, we have been able to reduce the odor significantly. The statistic, it is, I think P value was 0.01 versus placebo, even though this was a small study. We reduced pain, that was a significant reduction. We also monitored their psychological state, and there was a significant improvement in patient-reported outcomes. I think that gives me a lot of comfort that we have a very strong efficacy signal.