Fulcrum Therapeutics, Inc. (FULC) Earnings Call Transcript & Summary

Good morning, ladies and gentlemen. Thank you for standing by. Welcome to today's conference call regarding the merger agreement between Fulcrum Therapeutics and Slate Medicines. [Operator Instructions] Please be advised the call is being recorded and will be available for replay on the Fulcrum Therapeutics website. I will now turn the conference over to Chris Brinzey.

Thank you, operator, and good morning, everyone. Before we begin, I'd like to remind you that today's call may include forward-looking statements, including statements related to the expected timing and completion of the proposed merger, the concurrent financing, Slate's clinical development plans and future performance of the combined company. These statements are subject to risks and uncertainties, which are described in our current and future SEC filings, which we urge you to read as they become available. With that, I'll now turn the call over to Alex Sapir, President and Chief Executive Officer of Fulcrum Therapeutics.

That's great. Thanks, Chris, and good morning, everyone. This morning, we are excited to announce that Fulcrum has entered into a merger agreement with Slate Medicines in an all-stock transaction. Joining me on today's call is Greg Oakes, Chief Executive Officer of Slate Medicines, who is expected to become the Chief Executive Officer of the combined company following the closing of the transaction. Now, I will review the details of the proposed transaction and the concurrent financing, and Greg will then provide an overview of Slate, its strategy and its pipeline. Since our June announcement regarding pociredir, Fulcrum's Board and management team have been actively conducting a comprehensive review of strategic alternatives with the goal of maximizing long-term shareholder value and believe that this proposed combination with Slate represents a high potential value creation opportunity for Fulcrum stockholders. With the announced $245 million private placement of Slate's common stock and common stock equivalents that includes a syndicate of leading health care investors led by Frazier Life Sciences with participation from Forbion, RA Capital Management, Deep Track Capital, Foresite Capital, OrbiMed, RTW Investments and Mingxin Capital, we believe the combined company will be well capitalized to execute on its clinical development strategy. Upon consummation of the proposed transaction, the combined company's cash balance is expected to provide runway into 2029. Under the terms of the business combination agreement, on a fully diluted basis, premerger Fulcrum stockholders are expected to own approximately 5% of the combined company. Premerger Slate stockholders are expected to own approximately 55.9%, and investors participating in the concurrent private placement are expected to own approximately 39.1%. For a 5% ownership level in the combined company, Fulcrum expects to contribute a net cash balance at close of $20.3 million, providing Fulcrum stockholders the opportunity to participate in the potential upside of Slate's pipeline as it advances through clinical development. With the additional cash of approximately $270 million at close, Fulcrum intends to pay a special cash dividend in that amount to premerger Fulcrum stockholders. We would like to thank the Fulcrum and Slate Board members for their support in approving this transaction, which is, of course, subject to stockholder approval and customary closing conditions. Following the closing, Slate's Board of Directors is expected to serve as the Board of the combined company, and Slate's current senior management team will operate the combined company. The combined company is expected to be renamed Slate Medicines and begin trading on NASDAQ under the ticker symbol SLTE. We expect the merger proposal to close in the fourth quarter of 2026. So we at Fulcrum have been impressed with both the leadership and quality of programs at Slate and have high confidence in their ability to deliver on their strategy going forward. We believe this transaction offers our stockholders a compelling opportunity for both short- and long-term value creation. Now, at this point, I'd like to pass it over to Greg Oakes, CEO at Slate Medicines. Greg, over to you.

Thank you, Alex. We're thrilled today to announce our planned merger with Fulcrum Therapeutics. I want to thank the Fulcrum team and Board for their collaboration and confidence in Slate's team and strategy. Before I continue, I'll point out that additional information on Slate is available in our corporate overview, which can be found on the Slate website. Slate Medicines was founded with the mission to advance a pipeline of potentially best-in-class next-generation therapeutics that we believe can meaningfully expand treatment options for migraine patients. Migraine is far more than a headache. It is a prevalent and disabling neurological disease. Migraine is the leading cause of disability in people under the age of 50, and it disproportionately affects women. The migraine field has seen great advancements with the advent of CGRP-targeted therapeutics. However, a significant unmet need remains for many patients that do not fully respond to the existing therapeutics. In pivotal studies of CGRP-targeted therapeutics in chronic migraine prevention, only about half of patients achieved a greater than a 50% reduction in monthly migraine days, and only 20% achieved a greater than a 75% reduction. Despite many patients being underserved by the existing standard of care, the market for CGRP-targeted therapeutics was over $5 billion in 2025 and is projected to more than double to over $10 billion at peak. We believe that there is a significant opportunity to advance orthogonal approaches to migraine prevention and improve outcomes for patients. Executing on our ambitious mission requires a great team, and I'm fortunate to be surrounded at Slate by a group of experienced biopharma executives, including Neil Buckley, our President and Chief Operating Officer; Dr. Roger Cady, our Chief Medical Officer; and John Umstead, our Chief Financial Officer, all who have a personal commitment to improving treatment options in migraine. We are also supported by our newly announced scientific and clinical advisory board, comprising internationally recognized neurologists and headache researchers, giving us an exceptional vantage point as we work to bring a differentiated approach to migraine prevention. Our lead program, SLTE-1009, is a monoclonal antibody designed to bind both PACAP and VIP, two neuropeptides that play foundational role in migraine pathophysiology. PACAP blockade has shown encouraging clinical data in the prevention of migraine. And we believe the dual blockade of PACAP and VIP with a single monoclonal antibody offers the potential for enhanced efficacy relative to PACAP-only targeted therapeutics. SLTE-1009 was also engineered with half-life extension to enable subcutaneous dosing with the potential to enable quarterly administration. We have received clearance to initiate a Phase I healthy volunteer study in Australia with top line safety and pharmacokinetic data anticipated midyear 2027. Following that readout, we plan to move into a Phase II dose range finding study of SLTE-1009 in migraine patients in the second half of 2027. Beyond our lead program, we're also developing SLTE-2100, a bispecific antibody targeting PACAP, VIP and CGRP currently in lead optimization. This program is expected to enter clinical trials in the second half of 2027. We also have a third undisclosed program in the migraine space that we look forward to sharing more details on in the future. The $245 million private placement, combined with existing cash on hand, is expected to provide Slate a cash runway into 2029 and a number of potential value-driving catalysts, including our planned Phase I healthy volunteer study and a Phase II dose range finding study for SLTE-1009, the advancement of SLTE-2100 into the clinic and through a Phase IIa proof-of-concept study and further development of our pipeline. We're energized through our planned merger with Fulcrum to continue to build a world-class migraine-focused biotech company and advance our pipeline of potentially best-in-class next-generation therapeutics. We believe the combined company will be well positioned to deliver value for our combined stockholder base and, most importantly, for migraine patients. So on behalf of Slate Medicines, thank you to the Fulcrum team for your partnership, and we look forward to working closely together through completion of the merger. With that, I'll hand the call back to the operator.

Ladies and gentlemen, this concludes today's call. All parties may now disconnect.