Fulcrum Therapeutics (NASDAQ:FULC) held its first-quarter earnings conference call on Monday. Below is the complete transcript from the call.
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Summary
Fulcrum Therapeutics reported positive clinical data from its Phase 1b Pioneer trial for Posterior Dare in sickle cell disease, showing an increase in fetal hemoglobin levels and a reduction in vaso-occlusive crises.
The company initiated an open-label long-term dosing trial for Posterior Dare and plans to provide updates on clinical trial design following an upcoming end-of-phase meeting with the FDA.
Financially, Fulcrum Therapeutics reported a net loss of $22.2 million for Q1 2026, with cash and marketable securities of $333.3 million, providing a runway into 2029.
Full Transcript
OPERATOR
Good morning and welcome to Fulcrum Therapeutics First Quarter 2026 Financial Results and Business Update Conference Call. Currently, all participants are in a listen only mode. This call is being webcast live and can be accessed on the Investors section of Fulcrum’s website at www.fulcrumtx.do and is being recorded. Please be reminded that remarks during this call may contain forward looking statements within the meaning of the Private Securities Litigation Reform act of 1995 may include statements about the Company’s future expectations and plans, clinical development timelines and financial projections. While these forward looking statements represent Fulcrum’s views as of today, this should not be relied upon as representing the Company’s views in the future. Fulcrum may update these statements in the future, but is not taking on an obligation to do so. Please refer to Fulcrum’s most recent filings with the Securities and Exchange Commission for discussions of certain risks and uncertainties associated with the Company’s business. Leading the call today will be Alex Sapier, CEO and President of fulcrum. Joining Alex on the call are Alan Musso, Chief financial officer, and Dr. Ian Frazier, senior Vice President, Clinical Development. After providing updates on the Company’s key programs, there will be a brief Q and A in which the Fulcrum management team will be available for questions. With that, it’s my pleasure to turn the call over to Alex.
Alex Sapier (CEO and President)
That’s great. Thanks, Shannon and good morning everyone. We appreciate you all joining us today. The first quarter of 2026 was an important and exciting period for Fulcrum, highlighted by the positive clinical data we reported from the Phase 1b Pioneer trial of Poseradir in Sickle Cell disease. Now, as a reminder, sickle cell disease is a serious genetic blood disorder with a significant unmet need, affecting approximately 120,000 patients in the United States and millions more globally. Patients with sickle cell disease face a substantial disease burden, including chronic pain and fatigue, as well as serious complications such as vaso occlusive crises, stroke and progressive end organ damage, all of which result in a substantial reduction in life expectancy of over 20 years. Now, we have known for decades that increasing levels of fetal hemoglobin, or HbF, in patients with sickle cell disease leads to improvements in anemia and reductions in vaso occlusive pain crises. And so it was for that reason that that we were so pleased with the data that we reported in February, demonstrating that after only 12 weeks of treatment, 20 milligrams of Poseradir taken once daily demonstrated a robust and clinically meaningful increase in HBF from 7.1% at baseline to 19.3% at week 12, along with improvements in markers of hemolysis and improvements in anemia. We also observed continued progression toward pancellular expression of HbF, which we believe is critical for achieving meaningful clinical benefit. And importantly, we saw a reduction in the number of VOCs we would have expected in this severe patient population with 7 of the 12 patients experiencing no VOCs during the 12 week treatment period. And importantly, Poseradir has continued to be generally well tolerated with no treatment related serious adverse events reported to date. And so taken together, these data reinforce our conviction in posterior’s potential to address the underlying biology of sickle cell disease and support our belief that posterior has the potential to represent a differentiated or once daily oral treatment option for patients. Now, during the quarter we also initiated an open label long term dosing trial for patients in the Pioneer study and we recently enrolled our first patient in this new study. All patients in this long term dosing study previously completed 12 weeks of treatment as part of the Pioneer trial. Therefore, we expect to provide a distinct we expect this study to provide a distinct data set offering important insights into long term safety, durability of response and the effects of reinitiating treatment with posterior. We also continue to support initiatives aimed at improving the care journey for people living with sickle cell disease, including our recent collaboration with Medic Alert and the Sickle Cell Disease association of America or SCDAA to help improve access to patient specific care information in the emergency department setting. Looking Ahead we are now focused on the next stage of clinical development for posterior and we expect to provide an update in the design of our next trial later this quarter following our upcoming end of phase meeting with the FDA and receipt of the final meeting minutes. Pending FDA feedback from that end of phase meeting, we plan to initiate a potential registration enabling trial in the second half of 2026. And so with a strong balance sheet that provides cash Runway into 2029, we are well positioned to advance posterior through the next phase of clinical development. Now, before turning it over to Alan, I want to cover two other important corporate updates. First, I want to welcome Josh Lure to our Board of Directors. Josh brings to Fulcrum a deep experience and passion for sickle cell disease as well as a strong track record in advancing transformative therapies in this space, including his role in the development and approval of Oxbrida. We are honored to have Josh join FULCRUM at this important stage and secondly, I would also like to thank Alan for his years of dedication and leadership as he looks towards retirement later in the year. Alan has played a critical role in strengthening our balance sheet and instilling financial discipline across the organization and we are grateful for his continued commitment to Fulcrum as he remains in his role until a successor is named to ensure a smooth transition. And so with that, let me now turn it over to Alan to review our financial results. And again, Alan, thanks for all you’ve done for fulcrum.
Alan Musso (Chief Financial Officer)
Thanks Alex, and thank you for the kind words. It’s been a privilege to be part of Fulcrum’s progress and I’m proud of what we’ve accomplished together. With the impressive results from the Pioneer trial, a talented and motivated team and a strong capital base, the company is well positioned to deliver transformative therapy for sickle cell patients. I look forward to continue working with the team over the coming months and ensuring a successful transition. And with that, I’ll now go over our Results for the first quarter ended March 31, 2026. The research and development expenses were 14.1 million for the first quarter of 2026 compared to 13.4 million for the first quarter of 2025. The increase of 700,000 was primarily driven by higher employee compensation costs, including 400,000 of increased stock based compensation expense. General and Administrative expenses were 8.1 million for the first quarter of 2026 compared to 7 million for the first quarter of 2025. The increase of 1.1 million was primarily driven by higher employee compensation costs including 300,000 of increased stock based compensation expense as well as higher professional services costs. The net loss was 22.2 million for the first quarter of 2026 compared to a net loss of 20.4 million for the first quarter of 2025. Now turning to the balance sheet, we ended the first quarter of 2026 with cash cash equivalents of marketable securities of 333.3 million compared to 352.3 million as of December 31, 2025. The $19 million decrease was primarily due to cash used to fund our operating activities. And based on our current plans, we expect our existing cash, cash equivalents and marketable securities will be sufficient to fund our operating requirements into 2029, providing Runway to advanced Poseradir through the next phase of clinical development. And with that, I’ll turn it back over to you, Alex.
Alex Sapier (CEO and President)
That’s great. Thanks so much Alan. So Fulcrum has reached an important inflection point with the positive clinical data from our Pioneer trial Reinforcing our conviction in Poseradir’s potential in sickle cell disease. We are focused on the next stage of development and look forward to providing an update on our plans following our upcoming end of phase meeting with the FDA. And with a strong balance sheet and a dedicated team, we believe we are well positioned to advance Poseradir through the next phase of clinical development. And so with those brief remarks, Shannon, why don’t we go ahead and open up the line for questions?
OPERATOR
Thank you. As a reminder to ask a question, please press star 11 on your telephone and wait for your name to be announced. To withdraw your question, please press star 11 again. Please stand by while we compile the Q and A roster. Our first question comes from the line of Joe Schwartz with Lee Rink Partners. Your line is now open.
Joe Schwartz (Equity Analyst at Lee Rink Partners)
Hi. Thanks for taking my questions, Alan. Congrats on your upcoming retirement and thanks for your excellent stewardship of the company over the years. Alex, as you reflect on the experience gained through Pioneer, what are the most important things you’ve learned that you might not have fully appreciated going in? And how will those lessons shape your phase three design and execution? Yeah, it’s a great question, Joe. And I may start. And I’ll also turn it over to Ian to see if he wants to add anything. I mean, I think the one thing that I’ve really learned from Pioneer and talking with a lot of the investigators and hearing from those investigators, the conversations that they’ve had with their patients, is that there continues to be continued high, high, …
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