speaker
Operator

Good day and thank you for standing by. Welcome to the Connexa Pharmaceuticals first quarter 2026 earnings conference call. At this time, all participants are in listen-only mode. After the speaker's presentation, there'll be a question and answer session. To ask a question during the session, you'll need to press star 1-1 on your telephone. You will then hear an automated message advising your hand is raised. To withdraw your question, please press star 1-1 again. Please be advised, today's conference is being recorded. I would now like to end the conference over to your speaker today. Jonathan Kirshenbaum, Investor Relations, please go ahead.

speaker
Jonathan Kirshenbaum
Investor Relations

Thank you, Operator. Good morning, everyone, and thank you for joining Connexa's call to discuss our first quarter 2026 financial results and recent portfolio execution. A press release highlighting these results can be found on our website under the Investors section. As for the agenda, our Chief Executive Officer, Sanj K. Patel, will start with an introduction. From there, Ross Mote, our Chief Operating Officer, will provide an update on ARC List commercial execution. Then, Connexa's Chief Medical Officer, Dr. John Paolini, will review our KPL 387 development program and the ongoing Phase 2-3 clinical trial in recurrent pericarditis. After that, Mark Rogozin, our Chief Financial Officer, will review our first quarter of 2026 financial results. And finally, Sanj will share closing remarks and kick off the Q&A session, for which Evan Tesari, our Chief Strategy Officer, will also be on the line. Before getting started, please note that we will be making forward-looking statements today that are subject to risks and uncertainties that may cause actual results to differ materially from such statements. A review of these statements and risk factors can be found on this slide, as well as under the caption, Risk Factors, contained in our SEC filings. These statements speak only as the date of this presentation, and we undertake no obligation to update such statements except as required by law. I'll turn it over to Simon.

speaker
Sanj K. Patel
Chief Executive Officer

Thanks, Jonathan, and good day, everyone. ConiXa continues to build spread across the business, which is driven by both our commercial progress with Arclist and the advancement of our pipeline programs, including KPL 387 and KPL 1161. On the commercial side, the end of the first quarter marks the fifth anniversary of the FDA approval for Arclist in recurrent pericarditis. Through our consistent and effective execution over those past five years, we've established and developed the market for this debilitating disease. This has enabled a fundamental shift in the treatment paradigm for patients and led to significant growth for the ARCA strength choice. Within our clinical portfolio, we continue to advance the APL387 Phase II, Phase III study in recurrent eryconitis. Data from the Phase II dose focusing portion of the study are on track for the second half of this year. We also expect to start the Phase III portion of the program by the end of this year. In addition, we are advancing KPL1161 closer to the clinic. This is our SC-modified IL-1 alpha and beta inhibitor with a target profile of quarterly dosing And as we've previously shared, we plan to start a phase one study by the end of this year. Our robust financial position, together with profitable Arculus revenue growth, gives us the ability to invest in value creation across the business. Commercially, Arculus continues to be on a robust trajectory five years from launch. And we intend to capture the additional opportunity that remains across the recurrent pericarditis market. Adoption of long-term IL-1 alpha and beta inhibition with Arclist is expanding in the approximately 40,000 patients each year in the United States who experience recurrent pericarditis flares. In the first quarter of this year, this expanding adoption contributed to Arclist sales growing to $214.3 million. Looking to the rest of the year, the marked increase in both the breadth and depth of prescribing we observed in the first quarter provide momentum going forward. As a result, we've now raised our full year 2026 revenue guidance to $930 to $945 million from our previous guidance of $900 to $920 million. In summary, Kinexa is a well-capitalized, growth-orientated company that is well-positioned to maximize the substantial artless commercial opportunity that is available to us. The company's portfolio programs have numerous milestones throughout the rest of the year that also have the potential to create meaningful value. And now, Ross Moss.

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Investor presentation