Every 8-K that Climb Bio, Inc. (CLYM) has filed with the SEC in the last 24 months is listed below, newest first, and each one links through to the document itself with the summary and the scores our analysis gives it.
A 8-K covers material events a company has to report between its quarterly reports, so if you follow CLYM and want that one kind of document rather than the whole filing history, this is the page to keep. The company's other filings, of every form, are on the full CLYM filings page.
Climb Bio, Inc. (CLYM) reported positive initial Phase 1 data for CLYM116, its anti‑APRIL monoclonal antibody being developed for IgA nephropathy. In healthy volunteers, a single 320 mg subcutaneous dose produced an estimated half‑life of about 29 days and dose‑proportional exposure without evidence of target‑mediated drug disposition at effective dose levels.
The 320 mg dose achieved near‑complete APRIL suppression, with more than 90% free APRIL reduction maintained through 10 weeks and above 75% through 12 weeks, alongside roughly 60–75% reductions in IgA, Gd‑IgA1, and IgM over 12 weeks. CLYM116 was generally well‑tolerated, with no serious adverse events, dose‑limiting toxicities, Grade ≥3 adverse events, discontinuations, or hypogammaglobulinemia; common treatment‑emergent events included headache, upper respiratory tract infection, and mild injection‑site reactions. Based on integrated PK/PD modeling, Climb Bio has defined a target regimen of an 800 mg loading dose followed by 400 mg every 12 weeks and is enrolling the NAVIGATE‑2 Phase 2 IgA nephropathy study, with initial data expected in the first half of 2027 and a Phase 3 initiation planned in 2027 subject to regulatory feedback.
Climb Bio, Inc. reports that its collaborator Beijing Mabworks Biotech Co., Ltd. has dosed the first patient with immunoglobulin A nephropathy in a Phase 2 clinical trial in China. The study is being conducted under a collaboration between the two companies focused on this kidney disease indication.
Climb Bio, Inc. reported results for the quarter ended June 30, 2026 and highlighted progress across its budoprutug and CLYM116 programs. For CLYM116, the company plans an R&D Spotlight on September 3, 2026 to review initial Phase 1 PK/PD data in healthy volunteers and development plans in IgA nephropathy, and anticipates initiating dosing in a Phase 2 IgA nephropathy trial in the third quarter of 2026. A partner-led Phase 1/2 study in IgA nephropathy in China is also ongoing, with Phase 2 dosing expected to begin in the third quarter of 2026.
For budoprutug, enrollment continues in the global PrisMN Phase 2 trial in primary membranous nephropathy, with initial pharmacodynamic data from the low-dose cohort expected in the fourth quarter of 2026. Additional data in immune thrombocytopenia, systemic lupus erythematosus and from a subcutaneous formulation study are expected through late 2026 and 2027. The company completed a private placement on April 29, 2026 generating approximately $110 million in gross proceeds, supporting continued clinical advancement and extending its cash runway into the second half of 2028. Cash, cash equivalents and marketable securities totaled $239.2 million as of June 30, 2026. For the quarter, R&D expenses were $9.7 million, G&A expenses were $5.6 million, and other income, net was $1.9 million; the company reported a net loss for the period.
Climb Bio, Inc. reported that director Andrew Levin resigned from its board, effective June 29, 2026. On the same day, the board elected Breanna O’Reilly, Ph.D., as a new director, with a term running until the 2027 annual meeting and until a successor is in place.
As a non-employee director, Dr. O’Reilly received a stock option to purchase 70,284 shares at an exercise price of $13.36 per share, vesting in equal monthly installments over three years from June 29, 2026. She will also receive a $40,000 annual cash retainer and ongoing annual equity grants under the company’s non-employee director compensation policy, and is covered by an indemnification agreement for certain expenses related to her board service.
Climb Bio, Inc. entered an Open Market Sale Agreement with Jefferies LLC that allows it to sell shares of common stock with an aggregate offering price of up to $100.0 million through an at-the-market program under its existing Form S-3 shelf registration.
Sales, if made, will occur from time to time on the Nasdaq Global Market or otherwise at prevailing market prices, with Jefferies earning up to 3.0% of the gross sales price per share. Climb Bio also terminated its prior Equity Distribution Agreement with Oppenheimer, which had provided for up to $22.35 million of potential sales but resulted in no shares being sold before termination.
Climb Bio, Inc. reported that it has announced initial data from the ongoing Phase 1b portion of its Phase 1b/2a clinical study of budoprutug, an anti-CD19 monoclonal antibody, in adults with primary immune thrombocytopenia. The study is designed to guide dose and regimen selection and to assess safety, platelet response and B-cell depletion in this patient group.
The company stated that it expects to release additional data from this trial by year-end 2026. It also included extensive cautionary language that these plans and expectations are forward-looking and subject to numerous risks, including clinical, regulatory, competitive and financing uncertainties related to budoprutug, CLYM116 and other product candidates.
Climb Bio, Inc. reported that stockholders approved an amendment to its 2021 Equity Incentive Plan at the 2026 annual meeting. The change updates the automatic annual share increase so it is based on both common shares and any outstanding pre-funded warrants starting with future evergreen calculations.
The underlying plan authorizes up to 5,216,105 shares for equity awards, combining new and returning shares, and permits annual increases of up to 5% of the applicable share base. Stockholders also elected directors and approved other proposals by wide margins, and the amended plan was filed as an exhibit.
Climb Bio, Inc. reported translational pharmacometric modeling and initial Phase 1 safety data for CLYM116, its anti-APRIL monoclonal antibody. The data come from a Phase 1 study in Australia and a parallel Phase 1 study run by partner Beijing Mabworks Biotech in China.
Based on the safety profile observed so far and supportive preclinical results, Climb Bio plans to continue advancing CLYM116 in clinical development. Mabworks expects to begin dosing IgA nephropathy (IgAN) patients in the Phase 2 portion of its ongoing study in the third quarter of 2026, marking a move toward testing the drug in its target indication.
Climb Bio, Inc. reported first quarter 2026 results, continued progress across its two lead programs, and strengthened its balance sheet. The company recorded a net loss of $13.7 million for the three months ended March 31, 2026, compared with $20.8 million a year earlier, as research and development spending declined.
Cash, cash equivalents and marketable securities totaled $146.3 million as of March 31, 2026, and management expects this to fund operations into 2028, excluding proceeds from a recently completed private placement. On April 29, 2026, Climb Bio closed a $110 million private financing led by healthcare investors.
Clinically, the anti‑CD19 antibody budoprutug showed robust B‑cell depletion with its subcutaneous formulation in healthy volunteers, supporting further development in autoimmune diseases. Multiple Phase 1b/2a and Phase 2 trials in primary membranous nephropathy, immune thrombocytopenia and systemic lupus erythematosus are enrolling, with several data readouts anticipated in 2026.
Climb Bio, Inc. filed a current report describing an R&D spotlight focused on budoprutug, its anti-CD19 monoclonal antibody for immune‑mediated diseases. The company highlights robust B‑cell depletion with a subcutaneous formulation in healthy volunteers and ongoing trials in primary membranous nephropathy (pMN), immune thrombocytopenia (ITP), and systemic lupus erythematosus (SLE).
Budoprutug has received FDA Orphan Drug and Fast Track designations for pMN and showed durable B‑cell depletion, anti‑PLA2R antibody negativity in evaluable patients, and clinical remissions in a small Phase 1b pMN study. Climb Bio also notes its second program, CLYM116, an anti‑APRIL antibody for IgA nephropathy, and states it is well‑resourced with cash runway anticipated into 2028, supporting multiple planned 2026 data readouts across budoprutug and CLYM116.
Climb Bio, Inc. entered into a securities purchase agreement for a private placement of its common equity. The company is selling 9,481,000 common shares at $9.50 per share and pre-funded warrants to purchase 2,106,000 shares at $9.4999 per warrant, for aggregate gross proceeds of about $110.0 million before fees.
Each pre-funded warrant is immediately exercisable at $0.0001 per share, subject to beneficial ownership limits generally at 4.99% or 9.99%, and up to 33.0% for RA Capital, with an overall cap of 19.99% for other holders. Climb Bio also agreed to register the resale of the new shares and warrant shares within 45 days after closing, and states that existing cash plus anticipated net proceeds are expected to support continued execution toward late-stage development of its immune-mediated disease pipeline.
Climb Bio, Inc. reported that Senior Vice President, Finance and principal accounting officer Cindy Driscoll will separate from the company by mutual agreement, effective April 30, 2026. This creates a leadership change in the finance organization.
Chief Financial Officer Dr. Susan Altschuller, who has served as CFO since October 2025, will also become the company’s principal accounting officer as of the separation date. The company highlights her extensive prior CFO and financial leadership roles in several biopharmaceutical companies and notes that her existing compensation arrangements remain unchanged. The filing also states that she has no disclosable related-party transactions or family relationships with directors or officers.
Climb Bio, Inc. reported fourth quarter and full-year 2025 results showing continued investment in its immune-mediated disease pipeline and a stronger balance sheet. Cash, cash equivalents and marketable securities were $160.7 million as of December 31, 2025, which the company expects will fund operations into 2028.
Full-year 2025 research and development expenses rose to $46.7 million from $14.3 million, while general and administrative expenses increased to $21.2 million from $16.0 million, reflecting pipeline and corporate growth. Net loss narrowed to $59.9 million in 2025 from $73.9 million in 2024, with loss per share improving to $0.88 from $1.53.
The company highlighted progress in multiple clinical programs. Budoprutug is in ongoing trials for primary membranous nephropathy, immune thrombocytopenia and systemic lupus erythematosus, plus a completed Phase 1 study of a subcutaneous formulation, with initial data from several studies expected in 2026. CLYM116 is in a Phase 1 healthy volunteer study, supported by a partner-led Phase 1/2 trial in IgA nephropathy.
Climb Bio, Inc. reported that its drug development pipeline has progressed and outlined anticipated milestones for 2026, as described in an accompanying press release. The company highlighted updates for its key candidates, including budoprutug and CLYM116, and plans additional clinical activity during 2026.
Climb Bio also stated that, based on its current operating plan, its cash, cash equivalents and marketable securities are expected to fund operations into 2028, while cautioning that this projection depends on assumptions that may prove incorrect and capital could be used sooner. The company emphasized that many forward-looking statements about timelines, regulatory progress and financial runway are subject to significant risks and uncertainties.
Climb Bio, Inc. furnished a current report to share that it issued a press release on November 6, 2025 announcing its financial results for the quarter ended September 30, 2025. The press release is provided as Exhibit 99.1 to the report and is incorporated by reference. The company notes that this information is being furnished under the securities laws rather than treated as filed for liability purposes.
Climb Bio (CLYM) filed an 8-K announcing new long-term follow-up data for budoprutug, an anti‑CD19 monoclonal antibody in development for B‑cell mediated diseases. An abstract reports results from a previously conducted Phase 1b trial (NCT04652570) in primary membranous nephropathy.
The data showed long-term control of proteinuria for up to three years after initial dosing in four patients who received up to four doses of budoprutug. Three patients required no further immunosuppressive treatment during follow-up. No treatment‑related adverse events grade 3 or higher were observed in the trial.
The company’s forward‑looking statements section references development plans for budoprutug and CLYM116 and outlines risks including clinical progress, regulatory approvals, competition, intellectual property, and capital needs.
Climb Bio, Inc. filed an 8-K reporting an employment-related material event involving Susan Altschuller. The filing references an Offer Letter dated September 30, 2025 between Climb Bio and Dr. Altschuller and includes an electronic cover page in Inline XBRL dated October 1, 2025. The document also cites the company’s S-1 filed August 2, 2021, which contains an indemnification provision that may require the company to indemnify Dr. Altschuller for certain expenses (including attorneys’ fees), judgments, penalties, fines and settlement amounts reasonably incurred arising from her service to the company. The filing notes there are no family relationships between Dr. Altschuller and the company’s directors or officers.
Climb Bio, Inc. reported new preclinical results for its monoclonal antibody CLYM116, which targets APRIL and is being developed for IgA nephropathy. In a completed nonhuman primate study, CLYM116 showed deeper IgA reduction and a longer half-life compared with sibeprenlimab, a first-generation anti-APRIL antibody, suggesting a potential for less frequent dosing. Additional in vivo mouse studies showed enhanced APRIL elimination and antibody recycling versus sibeprenlimab.
The company plans, subject to regulatory clearance, to start a Phase 1 trial of CLYM116 in healthy volunteers in Q4 2025, with initial biomarker and dosing-interval data expected around mid-year 2026. Climb Bio is hosting a virtual investor event on September 29, 2025 to discuss these data, supported by a press release and presentation.