Connect Biopharma Holdings Limited (CNTB)
NASDAQ: CNTB · Real-Time Price · USD
2.520
0.00 (0.00%)
At close: Apr 24, 2026, 4:00 PM EDT
2.495
-0.025 (-0.98%)
After-hours: Apr 24, 2026, 7:13 PM EDT
← View all transcripts

Noble Capital Markets Emerging Growth Virtual Equity Conference

Jun 4, 2025

Speaker 1

Gary, the floor is yours.

Barry Quart
CEO, Connect Biopharma

Thank you, Robert. Appreciate the opportunity to be here, and welcome everyone. We'll start with the usual forward-looking statements. Please see our SEC filings for full description of risks. I really appreciate the opportunity to talk about the new chapter in Connect Biopharma. I like to think of it as Connect 2.0. Last year, the board made a decision to bring in a new management team, one with extensive experience in drug development, working with the FDA, working with investors, and running public biotech companies. We have focused our attention on what was the lead program, rademikibart, a second-generation IL-4 receptor alpha monoclonal antibody, which had previously been in both extensive studies for atopic dermatitis and asthma. We are focusing specifically on asthma and COPD, an area where the other first-generation IL-4 Dupixent has demonstrated significant activity.

We recently initiated two parallel phase 2 studies looking at an opportunity in acute exacerbations of patients with asthma and COPD, and we have sufficient cash to conduct these studies and have a runway into 2027. The other aspect of our focus, along with the development of rademikibart, has been to make Connect a more U.S.-centric organization. We have relocated our headquarters to San Diego and have been reducing our footprint in China. One of the main reasons for our refocusing on acute exacerbations is that market research has shown that having that indication would lead to a dramatic increase in chronic use compared to not having that acute indication. There is no other biologic that has an acute indication for asthma or COPD. In fact, they specifically say to not be used to treat acute symptoms or acute exacerbations. It would be a very unique, one-of-a-kind indication.

Third-party market research has indicated it could create an over $5 billion market opportunity worldwide. Looking at just the key points related to rademikibart in prior phase 2 asthma study, the product showed really quite profound increases in respiratory function as measured by FEV1, or the amount of air that can be forced out of the lungs in one second, with upwards of 420 mL improvement at 24 weeks. What was particularly interesting in evaluating the data was that I found that greater than 70% of the one-week benefit, which was also quite dramatic, was observed within 24 hours. The next morning after a dose, the patient had already benefited almost entirely from that dose, which is extremely fast onset for a biologic.

This is relevant because of the over 2 million patients that visit emergency departments every year in the United States for asthma or COPD acute exacerbations. This is an opportunity for a completely novel indication and use of a biologic product. We also found that in addition to the opportunity to help those patients having the acute exacerbation at that time, that within the four-week period of an acute exacerbation, approximately 50% of those patients will have either a worsening of that index exacerbation or have a second event. They are very vulnerable to coming back to the emergency department or hospital during that four-week period. That is very significant because the hospital does not get paid again during that if the patient returns during that period.

Again, as I mentioned, the other biologics, including Dupixent, explicitly say not to be used during this period because they've never been studied to treat an acute exacerbation. As noted, having that indication dramatically opens up the opportunity for the product both acutely as well as chronically, where clinicians indicated they would keep their patient on the drug if the patient was doing well. As noted, we have a cash runway into 2027. Here's the 10,000-foot view of Connect and rademikibart. The top is planned and ongoing studies. Now all the studies that have been planned are ongoing. The top two are the acute COPD and acute asthma studies recently initiated. Our partners in China are well on their way in terms of completing phase 3 in chronic asthma and atopic dermatitis.

We expect to see a filing first in atopic dermatitis and then followed by asthma. Previously, studies that have been completed of note are both chronic asthma, which was a global study, a large atopic dermatitis global study, and an atopic dermatitis study done entirely in China. Now refocusing on asthma and COPD, just a couple of highlights. Obviously, a dense slide, but I think it's really important to make sure people appreciate how many patients there are in the U.S. with asthma and COPD, and then notably how many patients come into the hospital every year for an acute exacerbation with over 1 million patients with asthma and over 1.3 million patients with COPD. A sizable percentage of these patients are hospitalized.

We have an opportunity looking at a demonstration of health economic benefit to reduce the number of people coming into the hospital, reduce the number of people being hospitalized. For those people who are hospitalized, hopefully reduce length of stay. A large percentage of patients have a return because of a second episode in four weeks. The goal is to reduce that as well. What's interesting is that asthma and COPD are global issues. As I mentioned, we have a partner in China who's developing rademikibart in the Chinese market. We own all worldwide rights outside of greater China. You can see here the numbers of patients going into the emergency department in Europe are actually remarkably similar to what we see in the U.S. I've already noted that having this acute indication drives the use chronically.

I think this is highlighted best on this chart, which shows on the bottom row in terms of using the product chronically. If patients received it acutely, so post-acute treatment, we saw a 75% preference share for using the product, which is a dramatic increase compared to the clinician's view of using the product just first time as a chronic product. Just some points again to remember that there's significant numbers of patients hospitalized for these acute exacerbations. The patients frequently come back. Right now, there's really no treatment that has come through the pipeline in the last 20- 30 years for acute exacerbations. It's been essentially ignored while a great deal of attention has been spent on chronic asthma and COPD.

Very quickly, we are developing, as noted, an IL-4 receptor alpha monoclonal antibody, a well-known mechanism of action because of the great success of Dupixent. It was studied in a large phase 2 study in chronic asthma in moderate to severe patients. This is really the key take-home message. This is looking at FEV1, again, a measure of patients' airway. Over time of the 24-week study, as you could see, very substantial improvements in lung function, which occur very rapidly. This is looking at the first week where the patient was scheduled to come into the clinic. You see an average of around 250 mL improvement. We also had home spirometry data, which showed that 73% of that benefit was obtained within 24 hours. By the second day, essentially 100% was obtained.

This just highlights the fact that, as expected for this mechanism, the drug works well in people who have an underlying inflammatory process associated with their asthma, which is identified by high eosinophil count. Patients were required to have an eosinophil count of greater than 150. In the initial protocol, that was changed to greater than 300 part of the way through. You could see that both the greater than 150 and greater than 300 show very dramatic improvement. We were also able to call out of the study patients who have more of a COPD characteristic. In these patients, you also see very dramatic improvements in FEV1, not surprising again based on the validated mechanism of IL-4. From this rapid improvement and very profound improvement in airway function, we initiated two parallel studies.

Press release went out a few weeks ago that these studies had started to enroll. These studies are designed randomized blinded trials looking at the use of rademikibart on top of standard of care to reduce the impact of the acute exacerbation both acutely as well as to avoid the patient coming back in for either worsening or a secondary exacerbation over four weeks. These studies were based on recently published data with Benralizumab, a U.K. study showing with Benralizumab being used in exactly the same fashion treating patients having an acute exacerbation of asthma or COPD. The key finding here is that the control group in the blue, as you could see, approximately 45% of the control arm, which is receiving standard of care, met a treatment failure endpoint within four weeks.

It gives us a very substantial opportunity to see a treatment benefit with such a high failure rate. It also points out that Benralizumab, as a kind of typical biologic, took around three weeks to start working. With our product, which starts working essentially overnight or within hours, we anticipate seeing even better results. This table, which is in our slide deck, just highlights that the improvements in FEV1 that we've seen compare extremely favorably to what's seen with the other products on the market for asthma. We think we have by far the greatest impact on airway function. We also think we have a differentiated safety profile compared to Dupixent, even though both are IL-4 targeted agents. This is looking at patients who get very high eosinophil count, particularly in people who start with high eosinophil count.

You're seeing a very high rate of patients going above 1,500 and even above 3,000 with Dupixent, where we don't see anything like that with rademikibart. In fact, we see a rate that's about half of what was seen with placebo. We actually decrease eosinophils where Dupixent increases eosinophils. If we think about the overall picture of drug development, some of the key important aspects of moving a product along is manufacturing. We know there's a long lead time on manufacturing, particularly biologics. We have already transferred manufacturing from our labs in China to a U.S. contract manufacturer. They've reproducibly manufactured the product here in the U.S. We have a new high-yield process that will be transferred to them either late this year or early next year. We have manufacturing well in hand with significant investment already been made there.

We have significant phase 2 data, which the FDA has reviewed and given us the consent to move into phase 3 for chronic asthma. We've put that on pause while we do the acute asthma and acute COPD studies so that when we move forward, we can move forward as a package. Looking at exclusivity, always important thing to evaluate with the product. We have exclusivity well into 2040 and likely beyond, depending on when we would get approval for the first indication. Long period of exclusivity. Just highlighting the differentiation with rademikibart, both in terms of what we think is greater improvements in FEV1, although cross-study comparison, definitely the speed of onset is certainly different than what's been published with any product. We see a differential safety profile, as already noted.

Last but not least, we have data from particularly atopic dermatitis where a study was conducted to compare Q2 week versus Q4 week dosing. Q2 week and Q4 week dosing looked identical. Based on that and the longer half-life, we believe there is an opportunity for using rademikibart Q4 weeks versus Q2 weeks with Dupixent. Our goal is to differentiate our product in every way that we can in going after a very significant commercial opportunity with this acute use in patients coming into the, and that drives very significant both acute and chronic opportunity. As looking at catalysts, we've already accomplished the first three important targets that we set for ourselves when we joined the company, the new management team.

That was to gain alignment and move forward with this new phase two opportunity in acute asthma and COPD and shift the company to be more U.S. centric with moving forward with typical U.S. SEC filings. We filed our first 10K and 10Q recently and identified our cash position of almost $84 million as of the end of March. That cash gives us the opportunity to fund the phase two program that I have already noted and gives us a runway into 2027. I appreciate everyone's time. Thank you very much. I will turn this back to Robert.

Thank you very much, Barry. That was a very informative presentation with lots of data and lots of really great information.

One of the first questions that I have for you is that when you distinguish your product against the current treatments, you mentioned that most are centered on chronic use. What's the current treatment for people presenting to the emergency room, and how are they treated, and how long do they spend in the hospital? Could you give us a little insight into the current treatments and how you would improve on that?

Yeah, great question. Thank you. So current treatment for patients with an acute exacerbation coming in look almost identical to what they would have received 20 years ago. Patients come in, they'll get steroid, usually either oral or IV, probably most likely IV, and they will get a high-dose bronchodilator. The goal is to get the patient stabilized, open up the airway. Unfortunately, steroids take quite a few hours to work.

That patient is going to likely be in the for four, maybe six hours waiting to see if they get stabilized and can be sent home. Those that do not stabilize, the airways do not improve enough, or are starting to get worse as they are sitting there, will get sent to a hospital bed upstairs. As noted in one of the slides, about 10% of asthma patients and a little over 40% of COPD patients who come into the get hospitalized from that visit. Our goal is to very quickly start to improve the airway function in these patients, hopefully being able to stabilize them and get them out of the sooner.

What we'll also be looking at in the studies we just initiated is trying to avoid that patient coming back to the in short order because they are starting to get worse once they're discharged, which is a very frequent occurrence. They get sent home with prednisone and a bronchodilator, and they still come back within days because they are starting to get worse again. Or they may come back in two to three weeks because they're having a second episode. Our goal is to impact on each one of these events. In people who are hospitalized, we're looking to see if we can shorten the duration of that hospitalization. Obviously, kind of the gold standard of getting hospitals to use your product is to save them money. If we can reduce a length of stay, that's a very significant cost savings.

We think there's a good opportunity to see that as well.

Yes, you just touched on my next question, and that's the cost savings and the opportunity to get these patients out of the emergency room faster and either get them to the point where they can be sent home or up to a ward and then shorten the hospital stay itself. Are there any numbers for what it costs on average for a patient to visit an emergency room for an acute episode and then the retreatment that you mentioned?

An emergency room visit can be kind of on the reimbursements, looks to be around $4,000. Now, we all know as we get bills from hospitals that you'll get a bill for 20, but the actual reimbursement they're going to get from the insurance company or payer is more likely in around the $4,000 range.

Obviously, if you go into a hospital setting, depending on how many days, that bill can run up quite substantially. We've been told that hospitals look at this particular setting as a likely loss because these patients tend to be more expensive than they get reimbursed for. We believe that there's a great opportunity to really show the hospital that using our product, once we collect the data from these trials, will save them a significant amount of money. The goal that we have set is to have a very low-cost manufacturing process, be able to provide this product at a low cost to the hospital and drive chronic use where in the chronic market opportunity, different presentation, different pricing structures, not fixed payments like in a hospital setting. We understand the dynamics of hospital versus outpatient.

We have already set in motion a plan to have a separate product for the hospital that could be used much more economically and fit within the DRG.

Yes. Like you mentioned, saving the hospital's money is key to getting them to use the product. Based on the efficacy data that you showed, it's great to help the patients, but helping the hospitals and the insurance companies is the other side of the coin. It's really important. Yes. It's good to see that all of those trends and advantages work in your favor. You mentioned the shift to chronic use where there are existing drugs. What are your plans there? Is there any data that you can share, either existing or coming up?

As shown on the slide deck, we have chronic data, placebo-controlled trial.

If we look across the other published studies with the approved drugs, we think we have amongst the best, if not clearly the best improvement in airway function. I think as a class, the IL-4s do much better in terms of improvement of lung function than some of the other mechanisms. We have some preclinical data we're working on that we believe will provide the underpinning for why that is and hope to have that data coming out later this year. From the point of view of forward-looking catalysts, we have, as I said, some preclinical data, which we hope will really highlight the differences of our product as well as early next year, the first half of next year, I should say specifically. We expect to have the results from the two phase 2 trials.

Data from the two studies, first half of next year, we have a runway into 2027.

Great. Okay. Just keeping an eye on the clock, this has been a really interesting presentation, and we could probably continue for another half hour. Are there any closing remarks other than the milestones that you just mentioned?

That's it for me. I appreciate the opportunity to be here. Thank you.

Thank you for joining us. Thank everyone online. Have a great day, everybody.

Powered by