Climb Bio Expands Pipeline Through an Exclusive License to Develop and Commercialize an Antibody Targeting the APRIL Pathway for IgA Nephropathy

Rhea-AI Summary

Climb Bio (NASDAQ: CLYM) has secured an exclusive license agreement with Beijing Mabworks Biotech for CLYM116, an anti-APRIL monoclonal antibody, for development and commercialization outside Greater China. The agreement focuses on treating IgA nephropathy, the most common form of glomerulonephritis worldwide.

CLYM116 is engineered to prevent APRIL signaling through a novel mechanism, potentially offering advantages over current APRIL-targeted therapeutics. The company will make a $9 million upfront payment to Mabworks, with additional milestone payments and low- to mid-single digit tiered royalties on net sales.

The company reported $212.9 million in cash and equivalents as of December 31, 2024, expecting to fund operations through 2027. Initial preclinical data for CLYM116 is anticipated later in 2025.

Positive

• Strong cash position of $212.9 million as of December 31, 2024
• Cash runway extended through 2027
• Pipeline expansion with potential best-in-class APRIL-targeting antibody
• Novel mechanism of action with potential advantages over existing treatments

Negative

• Additional $9 million cash outlay for upfront payment
• Future milestone payments and royalties will impact profitability
• Product still in early preclinical stage with no clinical data available

Insights

Biotech Research Analyst

The exclusive licensing deal for CLYM116 marks a strategic expansion into the IgA nephropathy therapeutic space, targeting the clinically validated APRIL pathway. The $9 million upfront payment with milestone-based structure represents a capital-efficient entry into this market. With $212.9 million in cash reserves providing runway through 2027, the deal appears well-structured financially.

The therapeutic's novel pH-dependent bind-and-release mechanism and Fc-engineering could provide competitive advantages over existing APRIL-targeted treatments. Key differentiators include enhanced lysosomal APRIL degradation and potentially improved dosing frequency. The extended cash runway through 2027 provides adequate buffer for both CLYM116 and budoprutug development programs.

Financial Analyst

This licensing agreement represents a calculated strategic investment with favorable deal terms. The $9 million upfront payment is modest relative to Climb Bio's $212.9 million cash position, preserving significant operational flexibility. The tiered royalty structure (low to mid-single digits) and milestone-based payments align well with industry standards while maintaining favorable economics.

The company's cash runway extension through 2027 suggests efficient capital allocation, providing coverage for both development programs without immediate dilution pressure. For a company with $132.4 million market cap, this deal structure enables pipeline expansion while maintaining financial stability.

Medical Research Analyst

The focus on IgA nephropathy, the most prevalent form of glomerulonephritis globally, represents a significant market opportunity. CLYM116's engineered properties - including enhanced serum half-life and dual-mechanism APRIL inhibition - suggest potential clinical advantages over current treatments. The pH-dependent bind-and-release design is particularly noteworthy for potentially achieving more complete APRIL signaling blockade.

The planned disclosure of preclinical data later in 2025 will be important in validating these theoretical advantages. The combination of CLYM116 with budoprutug creates a complementary B-cell targeted pipeline that could address multiple immune-mediated diseases.

Transaction Expands Climb Bio’s Pipeline of B-cell Targeted Therapeutics to Address Immune-mediated Diseases

New Program is a Highly Potent, Fc-engineered anti-APRIL Monoclonal Antibody Specifically Designed to Address Patient Needs

Preclinical Data Expected to be Shared Later in 2025

WELLESLEY HILLS, Mass., Jan. 09, 2025 (GLOBE NEWSWIRE) -- Climb Bio, Inc. (Nasdaq: CLYM) today announced it has entered into an exclusive license agreement with Beijing Mabworks Biotech Co., Ltd. (NEEQ Code: 874070, Mabworks) for rights to develop and commercialize MIL116 (now CLYM116), an anti-APRIL (A PRoliferation-Inducing Ligand) monoclonal antibody, in the territory outside of Greater China. Climb Bio believes CLYM116 is a potential best-in-class approach to address significant unmet need in patients with IgA nephropathy and other B-cell mediated diseases. This transaction furthers Climb Bio’s goal of becoming a leader in developing new treatment options for immune-mediated diseases, complementing the Company’s anti-CD19 antibody, budoprutug.

"Adding CLYM116 to our pipeline represents a pivotal moment for Climb Bio as we advance our ambition of becoming a leader in developing best-in-class treatments for patients with immune-mediated diseases," said Aoife Brennan, President and CEO of Climb Bio. "IgA nephropathy is the most common cause of glomerulonephritis worldwide, and we believe that inhibition of APRIL is both a clinically validated mechanism and potentially disease modifying approach for this indication. We look forward to rapidly advancing CLYM116 and sharing initial preclinical data later in 2025."

CLYM116, an Fc-engineered anti-APRIL monoclonal antibody, has the potential to address limitations of APRIL-targeted therapeutics currently in development. CLYM116 utilizes a novel mechanism of action to prevent APRIL signaling, potently blocking binding of APRIL to its receptors and also promoting lysosomal APRIL degradation via a pH-dependent bind-and-release design. Through its unique binding profile, CLYM116 has the potential to enable more rapid, deep and durable inhibition of APRIL signaling and IgA depletion. CLYM116 was engineered to increase serum half-life, potentially enabling an improved exposure profile and less frequent dosing in patients. CLYM116 is currently in IND-enabling studies, and Climb Bio plans to share data from the ongoing preclinical studies later in 2025.

“MIL116 (now CLYM116) has been specifically designed to meet the needs of patients with IgA nephropathy and has shown promising data in several preclinical models,” said Dr. Feng Li, Chairman of the Board and General Manager of Mabworks. “We are thrilled to partner with Climb Bio, given their focus on immune-mediated diseases, and leverage the capabilities and expertise of both organizations to advance this program to clinical trials as expeditiously as possible.”

Transaction Details
Under the terms of the agreement, Climb Bio will make an upfront cash payment of $9 million to Mabworks, and will be required to make certain additional payments upon the achievement of specified development, regulatory and commercial milestones, and pay low- to mid-single digit tiered royalties on net sales outside of Greater China. Further details on Climb Bio’s technology transfer and exclusive license agreement with Mabworks, CLYM116 and IgA nephropathy can be found in Climb Bio’s latest corporate presentation, which is available under the heading “Investors & News” at climbbio.com.

Financial Update
As of December 31, 2024, Climb Bio had cash, cash equivalents and short-term marketable securities of approximately $212.9 million. Following its entry into the license agreement, Climb Bio anticipates that its existing cash resources will be sufficient to fund its planned operations, including the development of budoprutug and CLYM116, through 2027.

About Climb Bio, Inc.
Climb Bio, Inc. is a clinical-stage biotechnology company developing therapeutics for patients with immune-mediated diseases. The Company’s pipeline includes, budoprutug, an anti-CD19 monoclonal antibody that has demonstrated B-cell depletion and has potential to treat a broad range of B-cell mediated diseases, and CLYM116, an APRIL-targeted monoclonal antibody currently in IND-enabling studies for IgA nephropathy. For more information, please visit climbbio.com.

Forward-Looking Statements
This press release 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 Climb Bio; expectations regarding the therapeutic benefits, clinical potential and clinical development of budoprutug and CLYM116; plans to optimize the administration of budoprutug; the anticipated benefits of Climb Bio’s license agreement with Mabworks; the sufficiency of Climb Bio’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. Climb Bio 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 associated with: the ability of Climb Bio to timely and successfully achieve or recognize the anticipated benefits of its acquisition of Tenet Medicines, Inc. and its license agreement with Mabworks; changes in applicable laws or regulation; the possibility that Climb Bio may be adversely affected by other economic, business and/or competitive factors; Climb Bio’s ability to advance budoprutug and CLYM116 on the timelines expected or at all and to obtain and maintain necessary approvals from the U.S. Food and Drug Administration and other regulatory authorities; obtaining and maintaining the necessary approvals from investigational review boards at clinical trial sites and independent data safety monitoring boards; replicating in clinical trials positive results found in early-stage clinical trials; competing successfully with other companies that are seeking to develop treatments for primary membranous nephropathy, immune thrombocytopenia, systemic lupus erythematosus, IgA nephropathy and other immune-mediated diseases; maintaining or protecting intellectual property rights related to budoprutug, CLYM116 and/or its other product candidates; managing expenses; and raising the substantial additional capital needed, on the timeline necessary, to continue development of budoprutug, CLYM116 and any other product candidates Climb Bio may develop. For a discussion of other risks and uncertainties, and other important factors, any of which could cause Climb Bio’s actual results to differ materially from those contained in the forward-looking statements, see the “Risk Factors” section, as well as discussions of potential risks, uncertainties and other important factors, in Climb Bio’s most recent filings with the U.S. Securities and Exchange Commission. In addition, the forward-looking statements included in this press release represent Climb Bio’s views as of the date hereof and should not be relied upon as representing Climb Bio’s views as of any date subsequent to the date hereof. Climb Bio anticipates that subsequent events and developments will cause Climb Bio’s views to change. However, while Climb Bio may elect to update these forward-looking statements at some point in the future, Climb Bio specifically disclaims any obligation to do so, except as required by law.

Investors
Chris Brinzey
ICR Healthcare
chris.brinzey@icrhealthcare.com
339-970-2843

Media
Jon Yu
ICR Healthcare
jon.yu@icrhealthcare.com
475-395-5375

FAQ

What is the financial impact of CLYM116 licensing deal on Climb Bio's cash position?

The deal requires a $9 million upfront payment, but Climb Bio maintains $212.9 million in cash and equivalents, sufficient to fund operations through 2027.

When will Climb Bio (CLYM) release preclinical data for CLYM116?

Climb Bio plans to share initial preclinical data for CLYM116 later in 2025.

What are the royalty terms for CLYM116 license agreement?

Climb Bio will pay low- to mid-single digit tiered royalties on net sales outside of Greater China.

What therapeutic area is CLYM116 targeting?

CLYM116 is targeting IgA nephropathy, the most common cause of glomerulonephritis worldwide.

What is the current development stage of CLYM116?

CLYM116 is currently in IND-enabling studies, with preclinical data expected later in 2025.