| Item 7.01 |
Regulation FD Disclosure. |
On September 29, 2025, Climb Bio, Inc. (the “Company”) will hold its previously announced virtual investor event focused on CLYM116, its preclinical-stage monoclonal antibody targeting APRIL (A Proliferation-Inducing Ligand) in development for IgA nephropathy (“IgAN”), beginning at 8:00 a.m. ET. During the investor event, the Company’s management team will, among other things, present new preclinical data from a completed nonhuman primate (“NHP”) study comparing CLYM116 to sibeprenlimab, a first-generation anti-APRIL monoclonal antibody.
Copies of the press release and presentation relating to the investor event are attached hereto as Exhibits 99.1 and 99.2, respectively, and are incorporated herein by reference. A live webcast of the event, as well as a replay, will be available under the “Investors & Media” section of the Company’s website: climbbio.com. The information contained in, or that can be accessed through the Company’s website, is not a part of this filing.
The information in this Item 7.01, including Exhibits 99.1 and 99.2, shall not be deemed “filed” for purposes of Section 18 of the Securities Exchange Act of 1934, as amended (the “Exchange Act”), or otherwise subject to the liabilities of that section, nor shall it be deemed incorporated by reference in any filing under the Securities Act of 1933, as amended, or the Exchange Act, except as expressly set forth by specific reference in such a filing.
On September 29, 2025, the Company issued a press release announcing new preclinical data from a completed NHP study comparing CLYM116 to sibeprenlimab, a first-generation anti-APRIL monoclonal antibody. The preclinical data demonstrated deeper IgA reduction and a longer half-life compared to sibeprenlimab and highlight the potential for CLYM116 to provide a differentiated activity profile with less frequent dosing for IgAN.
The preclinical NHP data demonstrated improvement versus sibeprenlimab:
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Subcutaneous formulation demonstrated high bioavailability (~85%), with a favorable tolerability profile. |
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Prolonged exposure observed compared to sibeprenlimab, with a ~2-3 times longer half-life across doses. |
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Deeper and more prolonged IgA reduction observed compared to sibeprenlimab after a single subcutaneous administration at equivalent doses (6 mg/kg), with >70% maximal reduction in IgA observed with CLYM116. |
Additional in vivo studies in mice showed enhanced APRIL elimination and antibody recycling relative to sibeprenlimab.
Subject to regulatory clearance, the Company plans to initiate a Phase 1 clinical trial of CLYM116 in healthy volunteers in the fourth quarter of 2025, with initial biomarker and dosing interval data anticipated mid-year 2026.
Forward-Looking Statements
This Current Report on Form 8-K contains “forward-looking statements” within the meaning of the Private Securities Litigation Reform Act of 1995, including without limitation statements regarding: future expectations, plans and prospects for the Company; expectations regarding the therapeutic benefits, clinical potential and clinical development of budoprutug and CLYM116; expectations regarding the timing of submitting an investigational new drug application or clinical trial application submission for CLYM116; the anticipated timelines for initiating a clinical trial of CLYM116 and reporting initial data; the anticipated benefits of the Company’s license agreement with Beijing Mabworks Biotech Co., Ltd. (“Mabworks”); the sufficiency of the Company’s cash resources for the period anticipated; and other statements containing the words “anticipate,” “believe,” “continue,” “could,” “estimate,” “expect,” “intend,” “may,” “plan,” “potential,” “predict,” “project,” “should,” “target,” “would,” “will,” “working” and similar expressions. Forward-looking statements are based on management’s current expectations of future events and are subject to a number of risks and uncertainties that could cause actual results to differ materially and adversely from those set forth in, or implied by, such forward-looking statements. The Company may not actually achieve the plans, intentions or expectations disclosed in these forward-looking statements, and you should not place undue reliance on these forward-looking statements. These risks and uncertainties include, but are not limited to, important risks and uncertainties
