UNITED STATES SECURITIES AND EXCHANGE COMMISSION WASHINGTON, DC 20549 FORM 10-Q (Mark One) ☒ QUARTERLY REPORT PURSUANT TO SECTION 13 OR 15(d) OF THE SECURITIES EXCHANGE ACT OF 1934 For the quarterly period ended June 30, 2025 OR ☐ TRANSITION REPORT PURSUANT TO SECTION 13 OR 15(d) OF THE SECURITIES EXCHANGE ACT OF 1934 For the transition period from to Commission File Number: 001-40708 CLIMB BIO, INC. (Exact Name of Registrant as Specified in its Charter) Delaware 83-2273741 (State or other jurisdiction of i ...

Exhibit 99.1 Climb Bio Reports Second Quarter 2025 Financial Results and Provides Business Updates Clinical Trials of Budoprutug in Immune Thrombocytopenia (ITP) and Systemic Lupus Erythematosus (SLE) Underway; Trial of Budoprutug in Primary Membranous Nephropathy (pMN) Expected to Initiate in the Coming Weeks Budoprutug Subcutaneous Formulation Demonstrated High Bioavailability and Favorable Tolerability in Non-clinical Studies; Phase 1 Trial Expected to Initiate in the Coming Weeks, with Initial Data Anti ...

Financial Performance - Climb Bio, Inc. reported a net loss of $20.8 million for the three months ended March 31, 2025, compared to a net loss of $1.7 million for the same period in 2024, resulting in an accumulated deficit of $250.7 million as of March 31, 2025[127]. - Total operating expenses for Q1 2025 were $23.0 million, up 666.0% from $3.0 million in Q1 2024[150]. - The net loss for Q1 2025 was $20.8 million, compared to a net loss of $1.7 million in Q1 2024, marking an increase of 1124.6%[150]. - General and administrative expenses rose from $1.9 million in Q1 2024 to $5.7 million in Q1 2025, reflecting a 197.3% increase[152]. - Research and development expenses increased from $1.1 million in Q1 2024 to $17.3 million in Q1 2025, a rise of 1488.2%[151]. - The company has not generated any revenue from product sales since inception and expects to continue incurring operating losses for the foreseeable future[132]. Cash and Investments - The company has cash, cash equivalents, and marketable securities totaling $197.8 million as of March 31, 2025, which is projected to fund operations through 2027[128]. - Cash, cash equivalents, and marketable securities as of March 31, 2025, were $197.8 million, down from $212.5 million as of December 31, 2024[155]. - Net cash used in operating activities for Q1 2025 was $15.4 million, significantly higher than $1.8 million in Q1 2024[164]. - Net cash used in investing activities for Q1 2025 was $42.8 million, primarily due to purchases of marketable securities[167]. - Interest income increased from $1.3 million in Q1 2024 to $2.3 million in Q1 2025, a growth of 70.5%[154]. - Foreign currency loss increased from $33,000 in Q1 2024 to $50,000 in Q1 2025, reflecting a 51.5% rise[153]. Research and Development - Budoprutug, the cornerstone product candidate, has shown promising results in a Phase 1b clinical trial for primary membranous nephropathy (pMN), with 60% of patients achieving complete remission of proteinuria[124]. - Climb Bio, Inc. received FDA clearance for a Phase 2 clinical trial of budoprutug in pMN and anticipates dosing the first patient in the second half of 2025[124]. - The company is also developing CLYM116, with preclinical data expected in the second half of 2025 and plans to submit an IND for a Phase 1 clinical trial in IgA nephropathy (IgAN) in the same timeframe[125]. - Total research and development expenses for the three months ended March 31, 2025, were $17.3 million, a significant increase from $1.1 million in the same period in 2024[140]. - The company anticipates substantial increases in research and development expenses as it conducts ongoing clinical trials and studies[142]. - The company anticipates that expenses will continue to increase as it advances product candidates and expands corporate infrastructure[158]. Corporate Actions - Climb Bio, Inc. acquired Tenet Medicines, Inc. for $52.8 million, including $41.9 million in common stock and $5.8 million in transaction costs[133]. - The company entered into a technology transfer and exclusive license agreement with Mabworks for CLYM116, involving an upfront payment of $9.0 million[134]. Regulatory and Compliance - The company is classified as an emerging growth company under the JOBS Act, allowing it to delay adopting new accounting standards until they apply to private companies[174]. - The company will remain an emerging growth company until it reaches total annual gross revenue of $1.235 billion or more, issues more than $1.0 billion of non-convertible debt, becomes a "large accelerated filer" with at least $700.0 million of outstanding equity securities, or until December 31, 2026[175]. - The consolidated financial statements may not be comparable to those of companies that comply with new accounting pronouncements as of public company effective dates[175]. - As a smaller reporting company, the company is not required to provide certain market risk disclosures[176].

Financial Performance - Climb Bio reported cash, cash equivalents, and marketable securities of $197.8 million as of March 31, 2025, expected to fund operations through 2027[8] - Research and Development (R&D) expenses for Q1 2025 were $17.3 million, significantly up from $1.1 million in Q1 2024[8] - General and Administrative (G&A) expenses for Q1 2025 were $5.7 million, compared to $1.9 million in the same period last year[8] - The net loss for Q1 2025 was $20.8 million, compared to a net loss of $1.7 million in Q1 2024, resulting in a net loss per share of $0.31[8] Clinical Trials and Regulatory Approvals - Climb Bio received FDA clearance for a Phase 2 clinical trial of budoprutug in primary membranous nephropathy (pMN) and a Phase 1b/2a trial in immune thrombocytopenia (ITP) in March 2025[4] - The company plans to initiate clinical studies for budoprutug in ITP and systemic lupus erythematosus (SLE) in the coming weeks, with pMN studies expected to start in the second half of 2025[3] - Climb Bio is advancing the CLYM116 program, with plans to submit an investigational new drug (IND) or clinical trial application (CTA) by year-end 2025[3] - The company is pursuing regulatory clearance for budoprutug clinical trials outside the U.S. for SLE, indicating a strategy for international market expansion[4] Leadership and Organizational Changes - The company appointed Kim Cobleigh Drapkin and Bo Cumbo as Independent Directors and Perrin Wilson, Ph.D., as Chief Business Officer in 2025[8] Product Pipeline - Climb Bio's pipeline includes budoprutug and CLYM116, targeting immune-mediated diseases with significant therapeutic potential[7]

Equity Distribution Agreement - Climb Bio, Inc. has entered into an equity distribution agreement with Oppenheimer & Co. Inc. for the issuance and sale of common stock[1] - Climb Bio, Inc. has entered into an Equity Distribution Agreement with Oppenheimer & Co. Inc. for the sale of common stock[159] - The Agreement allows for the sale of shares at a minimum market price, with specific limits on the number of shares sold in a single trading day[159] - The Company will pay Oppenheimer & Co. Inc. a cash compensation of up to 3.0% of the gross proceeds from the sales of Placement Shares[162] Registration and Compliance - The registration statement for the securities was filed and declared effective by the SEC on November 22, 2024[2] - The Company has filed a Registration Statement with the Commission, which has been declared effective prior to the issuance of Placement Notices[15] - The Company is not an "ineligible issuer" and has not been a shell company for at least 12 months[19] - The Company is classified as an "emerging growth company" under the Securities Act[20] - The Company has complied with the reporting requirements of the Exchange Act and its Common Stock is listed on Nasdaq[24] - The Company has not distributed any offering material other than the Registration Statement and Prospectus[22] - The Company is obligated to comply with all requirements imposed by the Securities Act and the Exchange Act to facilitate the sale of Placement Shares[98] - All required filings with the Commission under the Securities Act must be completed prior to the issuance of any Placement Notice[116] Placement Shares - The Company will provide a prospectus supplement specifically related to the placement shares to be issued under this agreement[2] - The Placement Shares have been duly authorized for issuance and will be validly issued, fully paid, and nonassessable[30] - The Company will file a prospectus supplement with the Commission detailing the number of Placement Shares sold and the Net Proceeds[86] - Placement Shares must be approved for listing on Nasdaq or an application for listing must be filed prior to the First Placement Notice Date[117] Financial and Operational Statements - The financial statements present fairly the consolidated financial position of the Company and its Subsidiaries, prepared in compliance with GAAP[51] - The Company and its Subsidiaries maintain a system of internal control over financial reporting that provides reasonable assurance regarding the reliability of financial reporting[53] - The Company has timely prepared and filed all required tax returns and paid all material taxes owed, except those being contested in good faith[36] - The Company and its Subsidiaries have not incurred any material liabilities or obligations that could result in a Material Adverse Effect[33] Corporate Governance and Compliance - The Company has taken all requisite corporate actions necessary for the execution and delivery of the Agreement[28] - The Company has established and maintains effective disclosure controls and procedures to ensure material information is communicated to its principal executive and financial officers[52] - The Company has not engaged in dealings with any Sanctioned Persons or in Sanctioned Countries since April 24, 2019[59] - The Company has complied with anti-bribery and anti-money laundering laws in all jurisdictions where it operates[56] - The Company has no knowledge of any material weaknesses in its internal controls over financial reporting[53] Indemnification and Liability - The Company agrees to indemnify the Agent and its affiliates against any losses or claims arising from untrue statements or omissions in the Registration Statement or Prospectus[119] - The Agent agrees to indemnify the Company against losses related to untrue statements or omissions made in reliance on the Agent's Information[120] - The Company and the Agent will contribute to total losses in proportion to the benefits received from the sale of Placement Shares[125] - The indemnity and contribution agreements will survive regardless of any investigations or the delivery of Placement Shares[127] Termination and Notices - The Company has the right to terminate the Agreement at any time with ten days' prior written notice, effective at 4:05 P.M. New York City Time on the tenth day following receipt of such notice[129] - The Agent can terminate the Agreement if any Material Adverse Effect occurs that may impair the ability to sell Placement Shares[128] - Any termination of the Agreement shall not incur liability for any party, except for certain provisions that remain in effect[133] - Notices must be in writing and delivered to specified addresses for both the Agent and the Company[134] Miscellaneous Provisions - The Agreement is governed by the laws of the State of New York, and both parties waive the right to a jury trial[141] - The Company acknowledges that no fiduciary relationship is created with the Agent in connection with the transactions contemplated by the Agreement[147] - The Agent may assign its rights and obligations to an affiliate without the Company's consent, provided the affiliate is a registered broker-dealer[137] - The Agreement is executed in counterparts, which together constitute one and the same instrument[152] - The Agreement is governed by U.S. federal laws, including the ESIGN Act of 2000[152] Use of Proceeds - The Company will use the Net Proceeds as described in the Prospectus in the section entitled "Use of Proceeds"[82] Insurance and Environmental Compliance - The Company is insured against customary losses and risks, with all insurance policies in full force and effect[62] - The Company must maintain insurance in amounts that are reasonable and customary for its business operations[95] - The Company must maintain all necessary environmental permits to conduct its business[96]

Financial Performance - The company incurred net losses of $73.9 million and $35.1 million for the years ended December 31, 2024 and 2023, respectively, with an accumulated deficit of $229.9 million as of December 31, 2024[710]. - The company expects to continue incurring operating losses for the foreseeable future, with no products approved for sale and no revenue generated since inception[715]. - The accumulated deficit increased from $156.0 million in 2023 to $229.9 million in 2024[744]. Cash and Investments - The company had cash, cash equivalents, and marketable securities of $212.5 million as of December 31, 2024, sufficient to fund operations through 2027 based on current estimates[711]. - As of December 31, 2024, cash, cash equivalents, and marketable securities totaled $212.5 million, up from $106.8 million in 2023[744]. - Net cash used in operating activities was $15.6 million in 2024, compared to $20.6 million in 2023, reflecting a net loss of $73.9 million[752][753]. - Net cash used in investing activities was $121.1 million in 2024, primarily due to purchases of marketable securities totaling $132.2 million[754]. - Net cash provided by financing activities was $130.7 million in 2024, mainly from the issuance of common stock in a private placement[757]. Research and Development - Research and development expenses totaled $65.995 million for the year ended December 31, 2024, a significant increase from $15.411 million in 2023[726]. - The company anticipates substantial increases in research and development expenses as it conducts ongoing clinical trials and studies[728]. - Budoprutug, the company's cornerstone product candidate, is in clinical development for primary membranous nephropathy, immune thrombocytopenia, and systemic lupus erythematosus, with FDA clearance for Phase 2 trials expected to begin in the second half of 2025[707]. - The company plans to announce preclinical data for the subcutaneous formulation of budoprutug in the first half of 2025 and initiate clinical development in the second half of 2025[707]. - CLYM116, a preclinical stage anti-APRIL monoclonal antibody, is being evaluated in IND-enabling studies, with preclinical data expected in the second half of 2025[708]. Operating Expenses - Total operating expenses increased by 103.6% from $40.3 million in 2023 to $82.0 million in 2024, primarily due to a $51.7 million expense related to acquired in-process research and development[736][737]. - General and administrative expenses decreased by 35.5% from $24.9 million in 2023 to $16.0 million in 2024, driven by a reduction in personnel-related expenses[741]. Internal Controls and Compliance - The company identified material weaknesses in internal control over financial reporting, with two remaining unremediated as of December 31, 2024[766]. - The company has a remediation plan for the identified material weaknesses in internal controls, disclosed in Item 9A of the Annual Report[766]. - The company is classified as an emerging growth company under the JOBS Act, allowing it to delay adopting new accounting standards until they apply to private companies[767]. - The company will remain an emerging growth company until it achieves total annual gross revenue of $1.24 billion or more, issues more than $1.0 billion of non-convertible debt, or meets other specified criteria[768]. Stock-Based Compensation - Stock-based compensation is measured based on estimated grant-date fair value, with the Black-Scholes option pricing model used for valuation[764]. - Changes in assumptions regarding stock-based compensation can materially affect the recognized expense in future periods[764]. Market Risk and Accounting Estimates - The company is not required to provide quantitative and qualitative disclosures about market risk as a smaller reporting company[769]. - The preparation of consolidated financial statements involves significant estimates and assumptions that may differ from actual results[762]. - Critical accounting estimates are those that require significant estimation uncertainty and could materially affect financial condition or results of operations[763]. - The consolidated financial statements may not be comparable to those of companies that comply with new accounting pronouncements as of public company effective dates[768].

Financial Position - Climb Bio has approximately $218 million in cash, cash equivalents, and marketable securities as of September 30, 2024, expected to fund operations through 2027[8]. Clinical Trials and Development - In the Phase 1b study of budoprutug for primary membranous nephropathy (pMN), 60% of patients achieved complete remission of proteinuria[5]. - Budoprutug demonstrated complete and sustained B-cell depletion in all patients, with undetectable levels of B-cells after just two doses as low as 100 mg[5]. - The company plans to initiate Phase 1b clinical trials in systemic lupus erythematosus (SLE) and immune thrombocytopenia (ITP) in the first half of 2025, subject to regulatory clearance[6][7]. - Budoprutug has been successfully formulated above 175 mg/ml for a potential subcutaneous dosing form, with non-clinical data expected in the first half of 2025[4]. - The strategic development of budoprutug targets three opportunity sets: IgG4-mediated diseases, IgG1-3 diseases affecting single organ systems, and complex systemic diseases[3]. - The company aims to advance the pMN clinical program to late-phase development expected in 2025[8]. - A single-arm, open-label study for chronic ITP will include a "treat-to-target" approach for personalized redosing based on individual patient needs[7]. - The Phase 1b trial in SLE will utilize serum biomarkers to accelerate proof-of-concept and optimize dosing[6]. Product Potential - Climb Bio emphasizes the potential of budoprutug as a differentiated anti-CD19 monoclonal antibody for B-cell mediated diseases[3].

Financial Performance - The company reported net losses of $8.9 million for Q3 2024, compared to $4.0 million for Q3 2023, and $65.5 million for the first nine months of 2024, compared to $31.5 million for the same period in 2023, indicating a significant increase in losses year-over-year [132]. - The company has an accumulated deficit of $221.5 million as of September 30, 2024, compared to $156.0 million as of December 31, 2023 [132]. - The net loss for the three months ended September 30, 2024, was $8.9 million, a 124.2% increase from a net loss of $4.0 million in the same period of 2023 [161]. - Total operating expenses for the nine months ended September 30, 2024, were $71.1 million, a 102.3% increase from $35.2 million in the same period of 2023 [166]. - Research and development expenses increased by 111.6% from $2.9 million for the three months ended September 30, 2023, to $6.1 million for the same period in 2024 [162]. - General and administrative expenses rose by 158.4% from $2.1 million for the three months ended September 30, 2023, to $5.5 million for the same period in 2024 [163]. - Acquired in-process research and development expense was $51.7 million for the nine months ended September 30, 2024, due to the acquisition completed on June 27, 2024 [167]. - General and administrative expenses decreased by 51.6% from $22.9 million for the nine months ended September 30, 2023 to $11.1 million for the nine months ended September 30, 2024 [169]. Cash and Funding - As of September 30, 2024, the company had cash, cash equivalents, and marketable securities totaling $217.9 million, up from $106.8 million as of December 31, 2023, providing sufficient funds to support operations through 2027 [133]. - The company anticipates that its cash, cash equivalents, and marketable securities will be sufficient to fund operations through 2027 [172]. - Net cash used in operating activities for the nine months ended September 30, 2024 was $10.0 million, consisting primarily of a net loss of $65.5 million [178]. - Net cash provided by financing activities for the nine months ended September 30, 2024 was $130.7 million, including $119.7 million from the issuance of common stock in a Private Placement [182]. - Net cash used in investing activities for the nine months ended September 30, 2024 was $67.7 million, primarily due to purchases of marketable securities [179]. - Future funding requirements will depend on various factors, including the timing and cost of research and development activities [173]. - The company may need additional funds to meet operational needs and capital requirements for clinical trials and other research and development expenditures [175]. Clinical Development - In a Phase 1b clinical trial of budoprutug for primary membranous nephropathy (pMN), 60% of patients achieved complete remission of proteinuria, and complete B-cell depletion was observed in all patients [127][141]. - The FDA cleared the IND for budoprutug in systemic lupus erythematosus (SLE) in October 2024, with plans to initiate a Phase 1b clinical trial in the first half of 2025 [137][146]. - The company plans to initiate a Phase 2 clinical trial of budoprutug for immune thrombocytopenia (ITP) in the first half of 2025, pending IND clearance [129][146]. - Budoprutug was well-tolerated in clinical trials, with no drug-related serious adverse events reported, and no deaths among patients [143]. - The company plans to announce non-clinical data on the subcutaneous formulation of budoprutug in the first half of 2025 [149]. - The strategic focus includes developing budoprutug for IgG4-mediated diseases, IgG1-3 related diseases, and complex systemic diseases, with potential applications beyond current indications [140]. Acquisition Details - The company completed the acquisition of Tenet Medicines, Inc. on June 27, 2024, issuing 31,238,282 shares at $3.84 per share, raising approximately $120.0 million before expenses [131]. - The total cost of the asset acquisition of Tenet was $52.8 million, including $5.8 million in transaction costs and $5.0 million related to a loan settled upon closing [136].

Core Points - The company Eliem Therapeutics, Inc. has changed its name to Climb Bio, Inc. to reflect its new focus on developing treatments for immune-mediated diseases following the acquisition of Tenet Medicines, Inc. [1][2] - Climb Bio will begin trading on Nasdaq under the new ticker symbol "CLYM" effective October 3, 2024 [1] - The lead product candidate, budoprutug, is an anti-CD19 monoclonal antibody with potential applications in various B-cell mediated diseases, including systemic lupus erythematosus, immune thrombocytopenia, and membranous nephropathy [2][4] Company Strategy - The name change and rebranding aim to symbolize the journey of patients with autoimmune diseases and the commitment to developing new treatments [2] - The company has refreshed its corporate website and adopted a new logo to align with its strategic direction [3] Product Development - Budoprutug, previously known as TNT119, is designed to deplete CD19-positive B cells, which may lead to a reduction in pathogenic autoantibodies [2] - In a Phase 1b clinical trial for membranous nephropathy, 60% of patients receiving four doses of budoprutug achieved complete remission of proteinuria [2]

Group 1 - Eliem Therapeutics, Inc. will participate in the Stifel 2024 Virtual Immunology and Inflammation Summit on September 17-18, 2024 [1] - The summit will feature 1x1 meetings format for discussions [1] - Eliem Therapeutics focuses on developing therapeutics for autoimmune-driven inflammatory diseases, including budoprutug, an anti-CD19 antibody [1] Group 2 - Budoprutug is designed for a broad range of autoimmune diseases, such as systemic lupus erythematosus, lupus nephritis, immune thrombocytopenia, and membranous nephropathy [1]