Core Viewpoint - Climb Bio, Inc. (CLYM) shows potential as a stock pick due to a recent "golden cross" event, indicating a bullish trend reversal [1][4]. Technical Analysis - A "golden cross" occurs when a stock's short-term moving average (50-day) crosses above its long-term moving average (200-day), suggesting a bullish breakout is likely [2]. - The successful golden cross event consists of three stages: a price decline bottoming out, the shorter moving average crossing above the longer one, and maintaining upward momentum [3]. Performance Metrics - Over the past four weeks, CLYM has gained 28.2%, indicating strong performance [4]. - CLYM currently holds a 2 (Buy) rating on the Zacks Rank, suggesting further breakout potential [4]. Earnings Outlook - Positive earnings outlook for the current quarter strengthens the bullish case for CLYM, with no earnings estimates decreasing in the past two months and two revisions higher [4]. - The Zacks Consensus Estimate for CLYM has also increased, further supporting the positive sentiment [4][5].

Company Overview - Climb Bio, Inc. is a clinical-stage biotechnology company focused on developing therapeutics for immune-mediated diseases [4] - The company's pipeline includes budoprutug, an anti-CD19 monoclonal antibody, and CLYM116, an anti-APRIL monoclonal antibody currently in IND-enabling studies for IgA nephropathy [4] Upcoming Investor Conferences - Climb Bio's executive team will participate in several investor conferences in September 2025, including: - Cantor Global Healthcare Conference on September 5, 2025, at 10:55 a.m. ET in New York, NY [2] - Baird Global Healthcare Conference on September 9, 2025, at 4:20 p.m. ET in New York, NY [2] - Morgan Stanley Annual Global Healthcare Conference on September 10, 2025, with one-on-one meetings only [2] - Stifel Virtual Immunology and Inflammation Forum on September 16, 2025, at 10:30 a.m. ET, conducted virtually [3] Webcast Information - Live webcasts of the conferences will be accessible via the "Investors and News" section of the Climb Bio website, with replays available approximately two hours after each event and archived for at least 30 days [3]

Core Viewpoint - Climb Bio, Inc. is actively engaging with investors through participation in multiple upcoming healthcare conferences, showcasing its commitment to transparency and investor relations [1][2][3]. Group 1: Upcoming Conferences - Climb Bio will participate in the Cantor Global Healthcare Conference on September 5, 2025, featuring a fireside chat and one-on-one investor meetings [2]. - The company will also attend the Baird Global Healthcare Conference on September 9, 2025, with a similar format of fireside chat and one-on-one meetings [2]. - Additionally, Climb Bio is scheduled for the Morgan Stanley Annual Global Healthcare Conference on September 10, 2025, which will consist of one-on-one meetings only [2]. Group 2: Virtual Forum - Climb Bio will take part in the Stifel Virtual Immunology and Inflammation Forum on September 10, 2025, offering a presentation and one-on-one investor meetings [3]. - Live webcasts of these events will be accessible on the Climb Bio website, with replays available approximately two hours after each event and archived for at least 30 days [3]. Group 3: Company Overview - Climb Bio, Inc. is a clinical-stage biotechnology company focused on developing therapeutics for immune-mediated diseases [4]. - The company's pipeline includes budoprutug, an anti-CD19 monoclonal antibody aimed at treating a range of B-cell mediated diseases, and CLYM116, an anti-APRIL monoclonal antibody currently in IND-enabling studies for IgA nephropathy [4].

Group 1 - Climb Bio, Inc. (CLYM) is currently outperforming its Medical peers with a year-to-date return of 12.2%, while the Medical sector has returned an average of -2.9% [4] - The Zacks Consensus Estimate for CLYM's full-year earnings has increased by 11.8% in the past quarter, indicating improved analyst sentiment and a more positive earnings outlook [4] - Climb Bio, Inc. holds a Zacks Rank of 2 (Buy), suggesting a favorable investment opportunity based on earnings estimates and revisions [3] Group 2 - Climb Bio, Inc. is part of the Medical - Biomedical and Genetics industry, which consists of 487 stocks and is currently ranked 98 in the Zacks Industry Rank [6] - The Medical - Biomedical and Genetics industry has an average year-to-date gain of 3.1%, indicating that CLYM is performing better than the industry average [6] - Another outperforming stock in the Medical sector is Cencora (COR), which has returned 31.2% year-to-date and also holds a Zacks Rank of 2 (Buy) [5]

[PART I. FINANCIAL INFORMATION](index=6&type=section&id=PART%20I.%20FINANCIAL%20INFORMATION) This section details Climb Bio's unaudited condensed consolidated financial statements and management's financial analysis [Item 1. Condensed Consolidated Financial Statements (unaudited)](index=6&type=section&id=Item%201.%20Condensed%20Consolidated%20Financial%20Statements%20(unaudited)) Climb Bio's unaudited condensed consolidated financial statements, covering balance sheets, operations, equity, cash flows, and detailed notes [Condensed Consolidated Balance Sheets](index=6&type=section&id=Condensed%20Consolidated%20Balance%20Sheets) Balance sheets show decreased total assets and equity, increased liabilities, driven by reduced cash and cash equivalents Condensed Consolidated Balance Sheets (thousands) | Metric | June 30, 2025 ($ thousands) | December 31, 2024 ($ thousands) | Change ($ thousands) | | :-------------------------- | :---------------------------- | :------------------------------ | :------------------- | | Total Assets | 192,386 | 217,187 | (24,801) | | Total Liabilities | 6,622 | 5,306 | 1,316 | | Total Stockholders' Equity | 185,764 | 211,881 | (26,117) | | Cash and cash equivalents | 22,682 | 87,229 | (64,547) | [Condensed Consolidated Statements of Operations and Comprehensive Loss](index=7&type=section&id=Condensed%20Consolidated%20Statements%20of%20Operations%20and%20Comprehensive%20Loss) Net loss significantly reduced for Q2 and H1 2025, primarily due to the absence of a large acquired in-process R&D expense in 2024 Condensed Consolidated Statements of Operations and Comprehensive Loss (thousands) | Metric | Three Months Ended June 30, 2025 ($ thousands) | Three Months Ended June 30, 2024 ($ thousands) | Six Months Ended June 30, 2025 ($ thousands) | Six Months Ended June 30, 2024 ($ thousands) | | :------------------------------------------ | :--------------------------------------------- | :--------------------------------------------- | :-------------------------------------------- | :-------------------------------------------- | | Net Loss | (8,666) | (54,889) | (29,447) | (56,586) | | Acquired in-process research and development, related party | — | 51,659 | — | 51,659 | | Research and development | 6,575 | 1,046 | 23,902 | 2,137 | | General and administrative | 4,102 | 3,667 | 9,793 | 5,581 | | Interest income | 2,173 | 1,485 | 4,460 | 2,826 | - Net loss decreased by **$46,223 thousand** for the three months ended June 30, 2025, and by **$27,139 thousand** for the six months ended June 30, 2025, compared to the respective periods in 2024, largely due to the absence of the **$51,659 thousand** acquired in-process R&D expense in 2025[17](index=17&type=chunk) [Condensed Consolidated Statements of Stockholders' Equity](index=8&type=section&id=Condensed%20Consolidated%20Statements%20of%20Stockholders'%20Equity) Stockholders' equity statements reflect changes from December 2024 to June 2025, driven by net losses, stock-based compensation, and unrealized gains Condensed Consolidated Statements of Stockholders' Equity (thousands) | Metric | December 31, 2024 ($ thousands) | June 30, 2025 ($ thousands) | | :-------------------------------- | :------------------------------ | :-------------------------- | | Total Stockholders' Equity | 211,881 | 185,764 | | Accumulated Deficit | (229,876) | (259,323) | | Additional Paid-in Capital | 441,727 | 444,762 | | Accumulated Other Comprehensive Income | 23 | 318 | - The accumulated deficit increased by **$29,447 thousand** from December 31, 2024, to June 30, 2025, reflecting the net loss for the six-month period[17](index=17&type=chunk)[20](index=20&type=chunk) [Condensed Consolidated Statements of Cash Flows](index=9&type=section&id=Condensed%20Consolidated%20Statements%20of%20Cash%20Flows) H1 2025 cash flows show significant usage in operating and investing activities, contrasting with prior year's financing cash from a private placement Condensed Consolidated Statements of Cash Flows (thousands) | Cash Flow Activity | Six Months Ended June 30, 2025 ($ thousands) | Six Months Ended June 30, 2024 ($ thousands) | | :-------------------------------------- | :-------------------------------------------- | :-------------------------------------------- | | Net cash used in operating activities | (26,582) | (2,486) | | Net cash provided by (used in) investing activities | (37,965) | 4,106 | | Net cash provided by financing activities | — | 128,417 | | Net change in cash and cash equivalents | (64,547) | 130,028 | | Cash and cash equivalents at end of period | 22,682 | 223,140 | - Net cash used in operating activities increased by **$24,096 thousand** in H1 2025 compared to H1 2024, primarily due to a lower non-cash IPR&D charge in 2025[22](index=22&type=chunk)[128](index=128&type=chunk)[129](index=129&type=chunk) - Investing activities shifted from providing cash in H1 2024 to using **$37,965 thousand** in H1 2025, mainly due to increased purchases of marketable securities[22](index=22&type=chunk)[130](index=130&type=chunk)[131](index=131&type=chunk) [Notes to Condensed Consolidated Financial Statements](index=10&type=section&id=Notes%20to%20Condensed%20Consolidated%20Financial%20Statements) Detailed notes explain Climb Bio's operations, accounting policies, acquisitions, licensing, financial instruments, commitments, stock compensation, net loss per share, segments, and subsequent events [1. Nature of Operations and Basis of Presentation](index=10&type=section&id=1.%20Nature%20of%20Operations%20and%20Basis%20of%20Presentation) Climb Bio is a clinical-stage biotech developing budoprutug and CLYM116, acquired Tenet, licensed CLYM116, and has **$259.3 million** accumulated deficit but sufficient capital for 12 months - Climb Bio, Inc. is a clinical-stage biotechnology company developing therapeutics for patients with immune-mediated diseases, with a pipeline including budoprutug and CLYM116[24](index=24&type=chunk) - The company completed the acquisition of Tenet Medicines, Inc. on June 27, 2024, and entered into an exclusive license agreement with Beijing Mabworks Biotech Co., Ltd. for CLYM116 rights on January 8, 2025[25](index=25&type=chunk)[26](index=26&type=chunk) - As of June 30, 2025, the company had an accumulated deficit of **$259.3 million** but believes its available cash, cash equivalents, and marketable securities of **$187.4 million** will be sufficient to meet operating requirements for at least the next twelve months[32](index=32&type=chunk)[33](index=33&type=chunk) [2. Summary of Significant Accounting Policies](index=11&type=section&id=2.%20Summary%20of%20Significant%20Accounting%20Policies) Climb Bio, an emerging growth company, delays new accounting standards, reports no material policy changes, and details policies on credit risk, suppliers, foreign currency, and fair value measurements - The company is an emerging growth company and has elected to use the extended transition period for complying with new or revised accounting standards[34](index=34&type=chunk) - No material changes to the company's significant accounting policies were reported from the Annual Report on Form 10-K for the year ended December 31, 2024[35](index=35&type=chunk) - The company relies on single-source suppliers and manufacturers for certain critical materials, posing a risk if these third parties fail to meet obligations[38](index=38&type=chunk) - Financial assets and liabilities measured at fair value are classified into Level 1 (quoted prices in active markets) and Level 2 (observable inputs other than Level 1) of the fair value hierarchy[40](index=40&type=chunk)[42](index=42&type=chunk) [3. Asset Acquisition and Private Placement with a Related Party](index=13&type=section&id=3.%20Asset%20Acquisition%20and%20Private%20Placement%20with%20a%20Related%20Party) Climb Bio acquired Tenet Medicines for **$52.8 million** on June 27, 2024, expensing **$51.7 million** as IPR&D, and raised **$120.0 million** from a concurrent private placement - The company completed the acquisition of Tenet Medicines, Inc. on June 27, 2024, which was accounted for as an asset acquisition[46](index=46&type=chunk)[48](index=48&type=chunk) - Total consideration for the acquisition was **$52.8 million**, with **$51.7 million** allocated to in-process research and development (IPR&D) and expensed due to no future alternative use[48](index=48&type=chunk) - A concurrent private placement generated approximately **$120.0 million** in gross proceeds from the issuance of **31,238,282** shares of common stock[25](index=25&type=chunk)[47](index=47&type=chunk) [4. Marketable Securities](index=14&type=section&id=4.%20Marketable%20Securities) Climb Bio's available-for-sale marketable securities primarily include corporate bonds, U.S. Treasury securities, and U.S. government agency debt securities, with long-term maturities between one and two years as of June 30, 2025 Marketable Securities (thousands) | Type | Amortized Cost ($ thousands) | Unrealized Gain ($ thousands) | Unrealized Loss ($ thousands) | Estimated Fair Value ($ thousands) | | :-------------------------------- | :--------------------------- | :---------------------------- | :---------------------------- | :------------------------------- | | **Short-term (June 30, 2025):** | | | | | | Corporate bonds | 35,127 | 20 | (4) | 35,143 | | U.S. Treasury securities | 26,860 | 20 | (2) | 26,878 | | **Total Short-term** | **61,987** | **40** | **(6)** | **62,021** | | **Long-term (June 30, 2025):** | | | | | | Corporate bonds | 69,676 | 193 | (3) | 69,866 | | U.S. Treasury securities | 20,242 | 103 | — | 20,345 | | U.S. government agency debt securities | 12,500 | 1 | (10) | 12,491 | | **Total Long-term** | **102,418** | **297** | **(13)** | **102,702** | - Long-term marketable securities as of June 30, 2025, have contractual maturity dates between one and two years[49](index=49&type=chunk) [5. Fair Value Measurements](index=14&type=section&id=5.%20Fair%20Value%20Measurements) Climb Bio measures financial assets at fair value, categorizing cash equivalents and U.S. Treasury securities as Level 1, and corporate bonds and U.S. government agency debt securities as Level 2, with no Level 3 transfers Fair Value Measurements at June 30, 2025 (thousands) | Asset Type | Level 1 ($ thousands) | Level 2 ($ thousands) | Level 3 ($ thousands) | Total ($ thousands) | | :-------------------------------- | :-------------------- | :-------------------- | :-------------------- | :------------------ | | **Fair Value Measurements at June 30, 2025:** | | | | | | Cash equivalents: Money market funds | 22,072 | — | — | 22,072 | | Marketable securities: U.S. Treasury securities | 47,223 | — | — | 47,223 | | Marketable securities: Corporate bonds | — | 105,009 | — | 105,009 | | Marketable securities: U.S. government agency debt securities | — | 12,491 | — | 12,491 | | **Total Assets** | **69,295** | **117,500** | **—** | **186,795** | - Cash equivalents and U.S. Treasury securities are valued based on quoted market prices (Level 1), while corporate bonds and agency securities are valued using quoted prices for similar securities (Level 2)[51](index=51&type=chunk) [6. Accrued Expenses and Other Current Liabilities](index=16&type=section&id=6.%20Accrued%20Expenses%20and%20Other%20Current%20Liabilities) Accrued expenses and other current liabilities increased to **$5.0 million** as of June 30, 2025, from **$4.1 million** at December 31, 2024, primarily due to higher accrued external research and development expenses Accrued Expenses and Other Current Liabilities (thousands) | Category | June 30, 2025 ($ thousands) | December 31, 2024 ($ thousands) | Change ($ thousands) | | :-------------------------------------- | :------------------------------ | :------------------------------ | :------------------- | | Accrued external research and development expenses | 3,614 | 1,237 | 2,377 | | Accrued payroll and related expenses | 914 | 1,997 | (1,083) | | Accrued professional fees | 472 | 746 | (274) | | Other accrued expenses and current liabilities | 37 | 89 | (52) | | **Total** | **5,037** | **4,069** | **968** | [7. Commitments and Contingencies](index=16&type=section&id=7.%20Commitments%20and%20Contingencies) Climb Bio has office lease obligations and significant contingent payment obligations under license agreements for budoprutug and CLYM116, including development, regulatory, commercial milestones, and royalties - The company amended its office lease in April 2025, adding **$0.2 million** in fixed payments through 2026, with an option to extend through 2027 for an additional **$0.1 million**[53](index=53&type=chunk) - Under the Acelyrin Asset Purchase Agreement, the company is obligated to make payments of up to **$157.5 million** upon achievement of various development, regulatory, and commercial milestones for budoprutug, plus single-digit royalties[57](index=57&type=chunk) - The Mabworks Agreement for CLYM116 includes a **$9.0 million** upfront payment (recorded as R&D expense in Q1 2025), up to **$30.0 million** for development/regulatory milestones for the first indication, additional amounts for up to two more indications, and up to **$832.0 million** for commercial milestones, plus tiered royalties[63](index=63&type=chunk)[65](index=65&type=chunk) - Milestone payments are recorded as expense when achievement is assessed as probable; as of June 30, 2025, **$0.8 million** was recorded for a ProBioGen milestone, but no other milestone expenses were recorded for Acelyrin, CRH, or Mabworks agreements[57](index=57&type=chunk)[59](index=59&type=chunk)[61](index=61&type=chunk)[65](index=65&type=chunk) [8. Stock-Based Compensation](index=20&type=section&id=8.%20Stock-Based%20Compensation) Climb Bio operates multiple equity incentive plans and an Employee Stock Purchase Plan, with stock-based compensation expense significantly increasing in 2025 and **$11.1 million** in unrecognized cost for unvested awards - The company has outstanding awards under its 2019 and 2021 Equity Incentive Plans, and adopted a 2025 Inducement Plan for new employees[68](index=68&type=chunk)[70](index=70&type=chunk) Outstanding Stock Options and Unvested Restricted Stock Units | Metric | June 30, 2025 | December 31, 2024 | | :-------------------------------- | :------------ | :---------------- | | Outstanding Stock Options | 5,663,022 | 2,817,751 | | Unvested Restricted Stock Units | 627,710 | 1,228,876 | Stock-Based Compensation Expense (thousands) | Expense Category | Three Months Ended June 30, 2025 ($ thousands) | Three Months Ended June 30, 2024 ($ thousands) | Six Months Ended June 30, 2025 ($ thousands) | Six Months Ended June 30, 2024 ($ thousands) | | :-------------------------------------- | :--------------------------------------------- | :--------------------------------------------- | :-------------------------------------------- | :-------------------------------------------- | | Research and development expenses | 521 | 287 | 1,427 | 556 | | General and administrative expenses | 492 | 225 | 1,608 | 421 | | **Total Stock-Based Compensation Expense** | **1,013** | **512** | **3,035** | **977** | - As of June 30, 2025, there was **$11.1 million** of total unrecognized compensation cost for unvested awards, and an additional **$3.0 million** for performance-based RSUs that became probable of vesting in August 2025[77](index=77&type=chunk) [9. Net Loss Per Share](index=22&type=section&id=9.%20Net%20Loss%20Per%20Share) Climb Bio reported a net loss for all periods, resulting in identical basic and diluted net loss per share due to the anti-dilutive effect of potentially dilutive securities - The company has generated a net loss in all periods presented, making basic and diluted net loss per share identical as potentially dilutive securities would be anti-dilutive[78](index=78&type=chunk) Potentially Dilutive Securities | Potentially Dilutive Securities | June 30, 2025 | June 30, 2024 | | :-------------------------------- | :------------ | :------------ | | Stock options to purchase common stock | 5,663,022 | 2,834,181 | | Unvested restricted stock awards and units | 627,710 | 1,233,943 | | **Total potentially dilutive shares** | **6,290,732** | **4,068,124** | [10. Segments](index=22&type=section&id=10.%20Segments) Climb Bio operates as a single segment focused on immune-mediated diseases, with R&D expenses disaggregated by program, showing significant increases in budoprutug and CLYM116 costs in 2025 - The company views its operations and manages its business as one operating and reportable segment, focused on developing therapeutics for patients with immune-mediated diseases[79](index=79&type=chunk) Direct Research and Development Expenses (thousands) | Direct Research and Development Expenses | Six Months Ended June 30, 2025 ($ thousands) | Six Months Ended June 30, 2024 ($ thousands) | Change ($ thousands) | | :--------------------------------------- | :-------------------------------------------- | :-------------------------------------------- | :------------------- | | Budoprutug | 10,662 | 42 | 10,620 | | CLYM116 | 9,265 | — | 9,265 | | Legacy programs | 73 | 107 | (34) | | Personnel-related | 3,209 | 1,825 | 1,384 | | Other research and development expenses | 693 | 163 | 530 | | **Total Research and Development Expenses** | **23,902** | **2,137** | **21,765** | - CLYM116 expenses for the six months ended June 30, 2025, include a **$9.0 million** upfront payment and associated direct transaction costs related to the Mabworks Agreement[81](index=81&type=chunk) [11. Subsequent Events](index=24&type=section&id=11.%20Subsequent%20Events) The One Big Beautiful Bill Act (OBBBA) was enacted on July 4, 2025, with potential impacts on federal tax law and other regulations, which the company is currently evaluating - The One Big Beautiful Bill Act (OBBBA) was enacted on July 4, 2025, after the reporting period[82](index=82&type=chunk) - The OBBBA includes significant changes to federal tax law and other regulatory provisions, the impact of which the company is currently evaluating[82](index=82&type=chunk) [Item 2. Management's Discussion and Analysis of Financial Condition and Results and Operations](index=25&type=section&id=Item%202.%20Management's%20Discussion%20and%20Analysis%20of%20Financial%20Condition%20and%20Results%20and%20Operations) This section provides management's perspective on Climb Bio's financial condition and results of operations, highlighting its clinical-stage status, recent acquisitions, operating expenses, liquidity, and future funding needs [Overview](index=25&type=section&id=Overview) Climb Bio is a clinical-stage biotech developing budoprutug and CLYM116, with significant operating losses and an accumulated deficit, but expects current capital to fund operations through 2027 - Climb Bio is a clinical-stage biotechnology company developing potential best-in-class therapeutics for immune-mediated diseases, with lead product candidate budoprutug and preclinical stage CLYM116[85](index=85&type=chunk)[89](index=89&type=chunk)[92](index=92&type=chunk) - The company received FDA clearance for Phase 2 clinical trial of budoprutug in pMN (March 2025) and IND clearances for Phase 1b in SLE (October 2024) and Phase 1b/2a in ITP (March 2025). A Phase 1 clinical trial for SC formulation of budoprutug is anticipated in H2 2025[91](index=91&type=chunk) - CLYM116 is currently in IND-enabling studies, with preclinical data expected in September 2025 and IND/CTA submission for IgAN anticipated in the second half of 2025[92](index=92&type=chunk) - The company incurred net losses of **$8.7 million** and **$29.4 million** for the three and six months ended June 30, 2025, respectively, with an accumulated deficit of **$259.3 million** as of June 30, 2025[94](index=94&type=chunk) - Existing cash, cash equivalents, and marketable securities of **$187.4 million** as of June 30, 2025, are estimated to fund planned operations through 2027[97](index=97&type=chunk) [Tenet Acquisition](index=29&type=section&id=Tenet%20Acquisition) On June 27, 2024, Climb Bio acquired Tenet Medicines, Inc. for **$41.9 million** in common stock, expensing **$51.7 million** as in-process research and development - Climb Bio acquired **100%** of Tenet Medicines, Inc. on June 27, 2024, in exchange for **5,560,047** shares of common stock, valued at **$41.9 million**[98](index=98&type=chunk) - The acquisition was accounted for as an asset acquisition, with **$51.7 million** recognized as in-process research and development (IPR&D) expense[98](index=98&type=chunk) [Mabworks Agreement](index=29&type=section&id=Mabworks%20Agreement) On January 8, 2025, Climb Bio licensed CLYM116 rights from Mabworks, involving a **$9.0 million** upfront payment expensed as R&D, plus future milestone and royalty obligations - On January 8, 2025, Climb Bio entered into the Mabworks Agreement for exclusive rights to develop and commercialize CLYM116 outside of Greater China[99](index=99&type=chunk) - A **$9.0 million** upfront cash payment was made to Mabworks and included in research and development expenses for the first quarter of 2025[99](index=99&type=chunk) - The agreement includes obligations for additional payments upon achievement of specified development, regulatory, and commercial milestones, and low-to-mid single-digit tiered royalties on net sales[99](index=99&type=chunk) [Components of Operating Results](index=29&type=section&id=Components%20of%20Operating%20Results) Operating expenses include R&D, acquired IPR&D, and G&A, all expected to increase, while other income primarily consists of interest earned on cash and marketable securities - Operating expenses are categorized into research and development, acquired in-process research and development (related party), and general and administrative expenses[100](index=100&type=chunk) - Research and development costs are expensed as incurred and are expected to increase substantially in the foreseeable future due to ongoing development activities[101](index=101&type=chunk)[103](index=103&type=chunk) - General and administrative expenses, primarily personnel-related and professional fees, are also expected to increase to support growth and potential commercialization activities[108](index=108&type=chunk)[109](index=109&type=chunk) [Research and Development](index=29&type=section&id=Research%20and%20Development) R&D expenses, including employee costs, preclinical/clinical development, manufacturing, facilities, and licensing, are expensed as incurred and are expected to increase significantly as product candidates advance - R&D expenses include employee-related costs, expenses for preclinical and clinical development (CROs, consultants), third-party manufacturing, facilities, and payments under licensing agreements[104](index=104&type=chunk) - Direct R&D expenses are tracked program-by-program, while indirect costs like employee and facility expenses are not allocated to specific programs[102](index=102&type=chunk) - R&D expenses are expected to increase substantially due to ongoing research, preclinical studies, and clinical trials, with timelines and costs being highly uncertain[103](index=103&type=chunk)[104](index=104&type=chunk) [Acquired In-Process Research and Development, Related Party](index=31&type=section&id=Acquired%20In-Process%20Research%20and%20Development,%20Related%20Party) Acquired IPR&D expense represents the fair value of consideration transferred in the Tenet Acquisition, allocated to R&D assets with no alternative future use - Acquired IPR&D expense consists of the fair value of consideration transferred in the Tenet Acquisition, allocated to R&D assets with no alternative future use[107](index=107&type=chunk) [General and Administrative](index=31&type=section&id=General%20and%20Administrative) General and administrative expenses, primarily personnel-related costs, legal fees, and professional services, are expected to increase with company growth and potential commercialization - General and administrative expenses primarily include personnel-related costs (salaries, bonuses, stock-based compensation), legal fees, professional fees (accounting, audit, consulting), insurance, and investor relations[108](index=108&type=chunk) - These expenses are expected to increase as the company expands its headcount to support growth strategy and potential commercialization activities[109](index=109&type=chunk) [Other Income (Expense)](index=31&type=section&id=Other%20Income%20(Expense)) Other income primarily consists of interest earned on cash, cash equivalents, and marketable securities, while foreign currency loss accounts for exchange rate fluctuations - Interest income is derived from interest earned on cash, cash equivalents, and marketable securities[110](index=110&type=chunk) - Foreign currency loss results from the remeasurement of foreign currency transactions to the U.S. Dollar[111](index=111&type=chunk) [Results of Operations](index=32&type=section&id=Results%20of%20Operations) This section compares Climb Bio's financial performance for Q2 and H1 2025 against 2024, detailing changes in operating expenses, other income, and net loss [Comparison of the Three Months Ended June 30, 2025 and 2024](index=32&type=section&id=Comparison%20of%20the%20Three%20Months%20Ended%20June%2030,%202025%20and%202024) Net loss significantly decreased by **$46.2 million** in Q2 2025 due to the absence of a **$51.7 million** acquired IPR&D expense in Q2 2024, while R&D and G&A expenses increased Comparison of the Three Months Ended June 30, 2025 and 2024 (thousands) | Metric | Three Months Ended June 30, 2025 ($ thousands) | Three Months Ended June 30, 2024 ($ thousands) | Change ($ thousands) | | :------------------------------------------ | :--------------------------------------------- | :--------------------------------------------- | :------------------- | | Net Loss | (8,666) | (54,889) | 46,223 | | Research and development | 6,575 | 1,046 | 5,529 | | Acquired in-process research and development, related party | — | 51,659 | (51,659) | | General and administrative | 4,102 | 3,667 | 435 | | Interest income | 2,173 | 1,485 | 688 | - Research and development expenses increased by **$5.5 million**, primarily due to **$4.5 million** in costs for the budoprutug program related to clinical trial start-up and manufacturing[114](index=114&type=chunk) - General and administrative expenses increased by **$0.4 million** due to higher personnel-related expenses from increased headcount[116](index=116&type=chunk) [Comparison of the Six Months Ended June 30, 2025 and 2024](index=33&type=section&id=Comparison%20of%20the%20Six%20Months%20Ended%20June%2030,%202025%20and%202024) Net loss decreased by **$27.1 million** in H1 2025 due to the absence of a **$51.7 million** acquired IPR&D expense in H1 2024, while R&D and G&A expenses significantly increased Comparison of the Six Months Ended June 30, 2025 and 2024 (thousands) | Metric | Six Months Ended June 30, 2025 ($ thousands) | Six Months Ended June 30, 2024 ($ thousands) | Change ($ thousands) | | :------------------------------------------ | :-------------------------------------------- | :-------------------------------------------- | :------------------- | | Net Loss | (29,447) | (56,586) | 27,139 | | Research and development | 23,902 | 2,137 | 21,765 | | Acquired in-process research and development, related party | — | 51,659 | (51,659) | | General and administrative | 9,793 | 5,581 | 4,212 | | Interest income | 4,460 | 2,826 | 1,634 | - Research and development expenses increased by **$21.8 million**, including **$10.6 million** for the budoprutug program and **$9.3 million** for the CLYM116 program (primarily a **$9.0 million** upfront payment)[120](index=120&type=chunk) - General and administrative expenses increased by **$4.2 million**, driven by a **$2.3 million** increase in personnel-related expenses and a **$1.2 million** increase in legal expenses[122](index=122&type=chunk) [Liquidity and Capital Resources](index=34&type=section&id=Liquidity%20and%20Capital%20Resources) This section discusses Climb Bio's liquidity, cash flow, future funding needs, and contractual obligations, noting reliance on equity financing and anticipated capital sufficiency through 2027 [Sources of Liquidity](index=34&type=section&id=Sources%20of%20Liquidity) Climb Bio primarily funds operations through equity sales, has no product revenue, and held **$187.4 million** in cash, cash equivalents, and marketable securities as of June 30, 2025 - The company has primarily funded operations through net proceeds from equity sales, including redeemable convertible preferred stock, an IPO, and a private placement in June 2024[125](index=125&type=chunk) - As of June 30, 2025, the company had **$187.4 million** in cash, cash equivalents, and marketable securities[125](index=125&type=chunk) - An Equity Distribution Agreement was entered into in March 2025 to sell up to **$22.4 million** in common stock via an at-the-market offering, but no shares were sold during the three and six months ended June 30, 2025[126](index=126&type=chunk) [Cash Flows](index=34&type=section&id=Cash%20Flows) H1 2025 saw **$26.6 million** net cash used in operating activities and **$38.0 million** in investing, contrasting with H1 2024's **$128.4 million** provided by financing activities Cash Flow Activities (thousands) | Cash Flow Activity | Six Months Ended June 30, 2025 ($ thousands) | Six Months Ended June 30, 2024 ($ thousands) | | :-------------------------------------- | :-------------------------------------------- | :-------------------------------------------- | | Net cash used in operating activities | (26,582) | (2,486) | | Net cash provided by (used in) investing activities | (37,965) | 4,106 | | Net cash provided by financing activities | — | 128,417 | - Net cash used in operating activities for H1 2025 was **$26.6 million**, primarily from a net loss of **$29.4 million**, partially offset by non-cash charges and changes in operating assets/liabilities[128](index=128&type=chunk) - Net cash used in investing activities for H1 2025 was **$38.0 million**, mainly due to purchases of marketable securities, partially offset by maturities[130](index=130&type=chunk) - Net cash provided by financing activities for H1 2024 was **$128.4 million**, primarily from a private placement (**$119.7 million**) and stock option exercises (**$8.7 million**)[133](index=133&type=chunk) [Funding Requirements](index=36&type=section&id=Funding%20Requirements) Climb Bio's existing capital is estimated to fund operations through 2027, but increased expenses for product development and commercialization will necessitate substantial additional future capital - Existing cash, cash equivalents, and marketable securities are believed to be sufficient to fund operations through 2027, based on current operating plans[134](index=134&type=chunk) - Expenses are expected to increase for advancing product candidates, expanding corporate infrastructure, and potential commercialization, necessitating substantial additional capital in the future[134](index=134&type=chunk)[135](index=135&type=chunk) - Failure to obtain necessary capital on acceptable terms could force delays, reductions, or termination of product development programs, commercialization efforts, or other operations[136](index=136&type=chunk) [Contractual Commitments and Obligations](index=37&type=section&id=Contractual%20Commitments%20and%20Obligations) Climb Bio has office lease obligations and contingent milestone and royalty payment obligations under asset purchase and license agreements, which are difficult to reliably estimate - The company has a lease agreement for office space with remaining fixed payments of **$0.4 million** through December 2026, and an option to extend for an additional **$0.3 million** through December 2027[139](index=139&type=chunk) - Obligations under asset purchase and license agreements for milestone and royalty payments are contingent upon future events (e.g., development, regulatory, commercial milestones, product sales) and cannot be reliably estimated for timing or likelihood[140](index=140&type=chunk) [Critical Accounting Policies and Estimates](index=37&type=section&id=Critical%20Accounting%20Policies%20and%20Estimates) Climb Bio's financial statements require management estimates and assumptions, with no material changes to critical accounting policies reported during Q2 or H1 2025 - The preparation of financial statements in conformity with U.S. GAAP requires management to make estimates and assumptions that affect reported amounts and disclosures[141](index=141&type=chunk) - There were no material changes to the company's critical accounting policies during the three or six months ended June 30, 2025[142](index=142&type=chunk) [Recently Issued Accounting Pronouncements Not Yet Adopted](index=37&type=section&id=Recently%20Issued%20Accounting%20Pronouncements%20Not%20Yet%20Adopted) This section refers to Note 2 of the condensed consolidated financial statements for details on recently issued accounting pronouncements not yet adopted - Information regarding recently issued accounting pronouncements not yet adopted is provided in Note 2 to the unaudited condensed consolidated financial statements[143](index=143&type=chunk) [Emerging Growth Company Status](index=37&type=section&id=Emerging%20Growth%20Company%20Status) Climb Bio is an "emerging growth company" and "smaller reporting company" under the JOBS Act, allowing reduced reporting requirements until December 31, 2026, or earlier if financial thresholds are met - The company is an "emerging growth company" and a "smaller reporting company" as defined in the JOBS Act and Exchange Act, respectively[144](index=144&type=chunk) - This status allows the company to take advantage of exemptions from various reporting requirements, including the auditor attestation requirements of Section 404 of the Sarbanes-Oxley Act[144](index=144&type=chunk) - The company could remain an "emerging growth company" until December 31, 2026, or earlier if its aggregate market value of common stock held by non-affiliates exceeds **$700 million**[144](index=144&type=chunk) [Item 3. Quantitative and Qualitative Disclosures About Market Risk](index=38&type=section&id=Item%203.%20Quantitative%20and%20Qualitative%20Disclosures%20About%20Market%20Risk) As a smaller reporting company, Climb Bio, Inc. is not required to provide quantitative and qualitative disclosures about market risk - The company is not required to provide quantitative and qualitative disclosures about market risk due to its status as a smaller reporting company[145](index=145&type=chunk) [Item 4. Controls and Procedures](index=38&type=section&id=Item%204.%20Controls%20and%20Procedures) Management concluded Climb Bio's disclosure controls were ineffective as of June 30, 2025, due to material weaknesses in internal control over financial reporting, with remediation efforts underway - Management concluded that disclosure controls and procedures were not effective as of June 30, 2025, due to material weaknesses in internal control over financial reporting[147](index=147&type=chunk) - Identified material weaknesses include a lack of sufficient professionals with appropriate accounting knowledge and experience, and a lack of formal accounting policies, procedures, and controls[152](index=152&type=chunk) - Remediation efforts include hiring qualified personnel, designing and implementing improved policies and controls, and implementing financial systems to enhance segregation of duties and data reliability[153](index=153&type=chunk)[154](index=154&type=chunk) - Despite the material weaknesses, management believes the unaudited condensed consolidated financial statements fairly present the company's financial condition, results of operations, and cash flows[148](index=148&type=chunk) [Material Weaknesses in Internal Control Over Financial Reporting](index=38&type=section&id=Material%20Weaknesses%20in%20Internal%20Control%20Over%20Financial%20Reporting) Climb Bio identified material weaknesses in internal control over financial reporting due to insufficient accounting personnel and a lack of formally designed policies and controls - Material weaknesses were identified due to a lack of sufficient professionals with appropriate accounting knowledge, training, and experience[152](index=152&type=chunk) - The company also lacked formally designed and maintained accounting policies, procedures, and controls for complete, accurate, and timely financial accounting, reporting, and disclosures, including segregation of duties[152](index=152&type=chunk) - These material weaknesses could result in a material misstatement of account balances or disclosures in annual or interim consolidated financial statements[150](index=150&type=chunk) [Remediation Efforts to Address Material Weaknesses](index=38&type=section&id=Remediation%20Efforts%20to%20Address%20Material%20Weaknesses) Remediation efforts include hiring qualified personnel, implementing improved policies and controls, formalizing procedures for complex transactions, and enhancing financial systems, with substantial progress reported - Remediation efforts include hiring qualified personnel with appropriate expertise and implementing improved policies, processes, and internal controls, including senior management review and audit committee oversight[153](index=153&type=chunk) - The company has formalized policies and controls to identify and assess complex accounting transactions and implemented financial systems to improve segregation of duties and data reliability[153](index=153&type=chunk)[154](index=154&type=chunk) - Substantial progress has been made, but the effectiveness of these remediation steps will be concluded upon completion of efforts and subsequent evaluation[154](index=154&type=chunk) [Changes in Internal Control over Financial Reporting](index=40&type=section&id=Changes%20in%20Internal%20Control%20over%20Financial%20Reporting) No material changes in Climb Bio's internal control over financial reporting occurred during the quarter ended June 30, 2025 - No material changes in internal control over financial reporting occurred during the quarter ended June 30, 2025[155](index=155&type=chunk) [PART II. OTHER INFORMATION](index=41&type=section&id=PART%20II.%20OTHER%20INFORMATION) This section provides other information, including legal proceedings, risk factors, equity sales, defaults, mine safety, and exhibits [Item 1. Legal Proceedings](index=41&type=section&id=Item%201.%20Legal%20Proceedings) As of the filing date, Climb Bio, Inc. was not involved in any material legal proceedings - The company is not party to any material legal matters or claims as of the date of filing this Quarterly Report[158](index=158&type=chunk) [Item 1A. Risk Factors](index=41&type=section&id=Item%201A.%20Risk%20Factors) This section outlines numerous risks that could materially affect Climb Bio's business, financial condition, and results of operations, spanning financial, development, legal, third-party, IP, operations, and common stock aspects [Risks Related to our Financial Position and Need for Additional Capital](index=41&type=section&id=Risks%20Related%20to%20our%20Financial%20Position%20and%20Need%20for%20Additional%20Capital) Climb Bio has significant losses and an accumulated deficit, requires substantial additional capital for product commercialization, and faces risks of dilution from equity offerings and insufficient funds for contingent obligations - The company has incurred significant operating losses since inception, with an accumulated deficit of **$259.3 million** as of June 30, 2025, and does not expect to generate revenue for the foreseeable future[161](index=161&type=chunk)[162](index=162&type=chunk) - Future success is primarily dependent on regulatory approval and commercialization of product candidates, which will require substantial additional capital[167](index=167&type=chunk) - The company has significant potential future obligations under license agreements (Acelyrin, CRH, ProBioGen, Mabworks) for contingent development, commercial, sales, and regulatory milestones and royalties, which may materially harm development efforts if funds are insufficient[165](index=165&type=chunk)[166](index=166&type=chunk) - Raising additional capital through equity offerings could dilute stockholders' ownership, while debt financing may involve restrictive covenants[170](index=170&type=chunk) [Risks Related to our Business and the Development of our Product Candidates](index=46&type=section&id=Risks%20Related%20to%20our%20Business%20and%20the%20Development%20of%20our%20Product%20Candidates) Climb Bio's success depends on regulatory approval and commercialization of budoprutug and CLYM116, a complex process with uncertain outcomes, facing risks from clinical trial results, adverse events, patient enrollment, intense competition, and FDA disruptions - The company's future success is primarily dependent on the regulatory approval and commercialization of budoprutug and CLYM116, a process that is lengthy, complex, expensive, and uncertain[179](index=179&type=chunk)[210](index=210&type=chunk) - Preliminary, initial, or interim clinical trial results may change as more data become available and are not predictive of final results, potentially harming approval and commercialization efforts[208](index=208&type=chunk)[209](index=209&type=chunk) - Product candidates may cause adverse events or undesirable side effects, leading to clinical trial delays, termination, restrictive labels, or denial of regulatory approval[225](index=225&type=chunk)[226](index=226&type=chunk) - Difficulties in enrolling and retaining patients in clinical trials could result in significant delays, increased costs, or abandonment of development programs[229](index=229&type=chunk)[232](index=232&type=chunk) - The company faces significant competition from major pharmaceutical and biotechnology companies with greater resources and expertise, which could lead to competitors achieving regulatory approval first or developing superior therapies[240](index=240&type=chunk)[245](index=245&type=chunk)[246](index=246&type=chunk) - Disruptions at the FDA and other government agencies (e.g., funding cuts, personnel losses, regulatory reform, government shutdowns) could hinder the ability to obtain guidance and timely approval of product candidates[259](index=259&type=chunk)[260](index=260&type=chunk)[263](index=263&type=chunk) [Risks Related to Legal and Regulatory Compliance](index=65&type=section&id=Risks%20Related%20to%20Legal%20and%20Regulatory%20Compliance) Climb Bio faces risks from evolving healthcare laws (e.g., IRA drug pricing, fraud and abuse, data privacy), which could increase costs, limit market access, or result in penalties, and expedited regulatory pathways do not guarantee faster approval - Enacted and future legislation, such as the Inflation Reduction Act (IRA), may increase the difficulty and cost of obtaining marketing approval, restrict post-approval activities, and affect product pricing and reimbursement[266](index=266&type=chunk)[270](index=270&type=chunk)[271](index=271&type=chunk) - The IRA's Medicare drug price negotiation program and inflation rebates could limit the expected return on product candidates and the full value of patents[271](index=271&type=chunk)[273](index=273&type=chunk)[277](index=277&type=chunk) - Business operations are subject to federal and state healthcare fraud and abuse laws (e.g., Anti-Kickback Statute, False Claims Act, HIPAA), with non-compliance potentially leading to substantial penalties, exclusion from government programs, and reputational harm[293](index=293&type=chunk)[294](index=294&type=chunk)[298](index=298&type=chunk) - The company is subject to stringent and evolving U.S. and foreign data privacy and security laws (e.g., HIPAA, CCPA, GDPR), with actual or perceived failures leading to regulatory investigations, litigation, fines, and business disruptions[301](index=301&type=chunk)[303](index=303&type=chunk)[307](index=307&type=chunk)[315](index=315&type=chunk)[316](index=316&type=chunk) - While the company may seek expedited designations (Breakthrough Therapy, Fast Track, Priority Review, PRIME), receipt is not guaranteed and does not assure faster development, review, or ultimate approval[318](index=318&type=chunk)[324](index=324&type=chunk)[325](index=325&type=chunk)[326](index=326&type=chunk) - Accelerated approval, if granted, requires post-marketing confirmatory trials and may be withdrawn if predicted clinical benefits are not verified or conditions are not met[329](index=329&type=chunk)[332](index=332&type=chunk)[334](index=334&type=chunk) - Orphan drug designation for budoprutug in pMN may not guarantee market exclusivity or full benefits, as exclusivity can be waived or lost under certain circumstances, and regulations may change[339](index=339&type=chunk)[342](index=342&type=chunk)[343](index=343&type=chunk)[344](index=344&type=chunk)[345](index=345&type=chunk) [Risks Related to our Dependence on Third Parties](index=87&type=section&id=Risks%20Related%20to%20our%20Dependence%20on%20Third%20Parties) Climb Bio heavily relies on third parties for development and manufacturing, facing risks from their failures, supply disruptions, and inability to secure new collaborations, compounded by uncertainties in U.S. and international trade policies, especially with China - The company relies on third-party CROs to conduct, supervise, and monitor preclinical studies and clinical trials, which reduces control over these activities and poses risks if they fail to perform or meet deadlines[365](index=365&type=chunk)[366](index=366&type=chunk)[368](index=368&type=chunk) - Reliance on third-party, including single-source, manufacturers for product candidate materials increases the risk of insufficient quantities, unacceptable costs, or supply disruptions, which could delay development or commercialization[378](index=378&type=chunk)[379](index=379&type=chunk)[386](index=386&type=chunk) - The company is dependent on third parties for raw materials, and loss of key suppliers or supply disruptions could impede development, manufacturing, and marketing efforts[393](index=393&type=chunk)[395](index=395&type=chunk)[396](index=396&type=chunk) - Future product development and commercialization may require additional collaborations, which are competitive and may not be available on acceptable terms, potentially altering development plans[397](index=397&type=chunk)[399](index=399&type=chunk)[402](index=402&type=chunk) - Uncertainty surrounding U.S. and international trade policies, particularly with China (e.g., tariffs, proposed BIOSECURE Act targeting Chinese biotechnology companies), may adversely impact business by disrupting supply chains and restricting partnerships with foreign vendors like WuXi and Mabworks[404](index=404&type=chunk)[406](index=406&type=chunk)[407](index=407&type=chunk)[408](index=408&type=chunk) [Risks Related to Intellectual Property](index=97&type=section&id=Risks%20Related%20to%20Intellectual%20Property) Climb Bio heavily relies on in-licensed IP, facing risks of license termination, patent challenges, and infringement claims, with global protection being expensive and uncertain, and patent terms potentially inadequate - The company heavily relies on patents, know-how, and other intellectual property licensed from third parties (e.g., CRH for budoprutug, Mabworks for CLYM116)[411](index=411&type=chunk) - Failure to comply with obligations under license agreements could lead to termination of licenses, loss of important intellectual property rights, and inability to develop or commercialize product candidates[413](index=413&type=chunk) - There is no assurance that current or future patent applications (14 pending U.S. provisional for budoprutug, one in-licensed PCT for CLYM116) will result in issued patents or provide competitive advantage[418](index=418&type=chunk)[420](index=420&type=chunk) - Issued patents may be challenged, invalidated, narrowed, or held unenforceable by third parties, leading to loss of exclusivity or freedom to operate[421](index=421&type=chunk)[426](index=426&type=chunk)[443](index=443&type=chunk) - Reliance on third parties for development and manufacturing increases the risk of trade secret discovery, misappropriation, or unauthorized disclosure, which would harm the company's competitive position[446](index=446&type=chunk)[447](index=447&type=chunk)[449](index=449&type=chunk)[514](index=514&type=chunk)[515](index=515&type=chunk) - The company may become involved in lawsuits to protect or enforce its patents, or face claims of infringing third-party intellectual property rights, which are expensive, time-consuming, and could result in substantial damages or injunctions[450](index=450&type=chunk)[451](index=451&type=chunk)[501](index=501&type=chunk)[502](index=502&type=chunk)[505](index=505&type=chunk)[506](index=506&type=chunk) - Patent terms may be inadequate to protect the company's competitive position for an adequate amount of time due to the lengthy development and regulatory review processes[481](index=481&type=chunk)[483](index=483&type=chunk)[490](index=490&type=chunk) [Risks Related to our Business Operations and Employee Matters](index=118&type=section&id=Risks%20Related%20to%20our%20Business%20Operations%20and%20Employee%20Matters) Climb Bio faces risks from cyberattacks, dependence on key personnel, employee misconduct, international operations, limitations on NOL carryforwards, and challenges associated with growth through acquisitions or investments - Information technology systems and data are vulnerable to cyberattacks, malicious activity, and security incidents, which could lead to unauthorized data access/loss, material disruption of development programs, regulatory investigations, litigation, fines, and reputational harm[526](index=526&type=chunk)[527](index=527&type=chunk)[528](index=528&type=chunk)[533](index=533&type=chunk)[538](index=538&type=chunk)[542](index=542&type=chunk) - The company is highly dependent on attracting and retaining qualified managerial, scientific, and medical personnel; the loss of key individuals could impede development and business plans[545](index=545&type=chunk)[546](index=546&type=chunk) - The company is exposed to the risk of fraudulent conduct or other illegal activity by employees, independent contractors, and third parties, including non-compliance with regulatory standards and healthcare fraud and abuse laws[547](index=547&type=chunk)[548](index=548&type=chunk) - Any international operations expose the company to business, regulatory, political, operational, financial, pricing, and reimbursement risks associated with doing business outside the U.S.[551](index=551&type=chunk) - The company may not be able to fully utilize its net operating loss (NOL) carryforwards due to "ownership change" rules under Sections 382 and 383 of the Internal Revenue Code, potentially increasing future tax obligations[553](index=553&type=chunk)[555](index=555&type=chunk) - Growth through acquisitions or investments (e.g., Tenet acquisition, Mabworks Agreement) involves numerous risks, including integration difficulties, unanticipated costs, diversion of management attention, and potential dilution of stockholders[556](index=556&type=chunk)[558](index=558&type=chunk)[560](index=560&type=chunk) [Risks Related to our Common Stock](index=126&type=section&id=Risks%20Related%20to%20our%20Common%20Stock) Climb Bio's common stock price is volatile, with no anticipated dividends, and faces risks from substantial share sales, anti-takeover provisions, concentrated ownership, material weaknesses in internal controls, and exclusive forum provisions - The trading price of the company's common stock has been volatile and may continue to be influenced by factors such as clinical trial results, regulatory decisions, market conditions, and analyst reports[561](index=561&type=chunk)[563](index=563&type=chunk) - The company does not anticipate paying cash dividends, making capital appreciation the sole source of gain for stockholders in the foreseeable future[565](index=565&type=chunk) - Sales of a substantial number of common shares into the public market, including those from equity compensation plans and private placements, could cause the market price to decline significantly and dilute existing stockholders' ownership[568](index=568&type=chunk)[570](index=570&type=chunk)[571](index=571&type=chunk) - Anti-takeover provisions in charter documents and Delaware law could make an acquisition more difficult and limit attempts by stockholders to replace or remove current management[573](index=573&type=chunk)[575](index=575&type=chunk) - Concentration of ownership among executive officers, directors, and principal stockholders (e.g., RA Capital Management L.P. with **46.4%**) may limit new investors' influence and reduce the public float, potentially depressing the stock price[580](index=580&type=chunk)[581](index=581&type=chunk) - Identified material weaknesses in internal control over financial reporting, if not remediated, could impair the ability to produce accurate financial statements and adversely affect the business and stock price[582](index=582&type=chunk)[585](index=585&type=chunk)[587](index=587&type=chunk) - Exclusive forum provisions in the amended certificate of incorporation designate specific judicial forums for disputes, potentially restricting stockholders' ability to choose a favorable forum and increasing litigation costs[588](index=588&type=chunk)[589](index=589&type=chunk)[591](index=591&type=chunk) [General Risk Factors](index=133&type=section&id=General%20Risk%20Factors) Climb Bio faces general risks including potential securities litigation, limited equity analyst coverage, unfavorable global economic conditions, and the impact of its "emerging growth company" and "smaller reporting company" status on investor attractiveness - The company may become involved in securities litigation or stockholder derivative litigation, which is expensive and diverts management's attention and resources[593](index=593&type=chunk)[595](index=595&type=chunk) - Limited equity analyst coverage may adversely affect the market price and trading volume of the common stock[596](index=596&type=chunk)[597](index=597&type=chunk) - Unfavorable global economic conditions, including volatility, inflation, and geopolitical events, could adversely affect the business, financial condition, and ability to raise additional capital[598](index=598&type=chunk)[599](index=599&type=chunk)[601](index=601&type=chunk) - Being an "emerging growth company" and "smaller reporting company" allows for reduced reporting requirements, which may make the common stock less attractive to some investors, potentially leading to less active trading and more volatile prices[602](index=602&type=chunk)[603](index=603&type=chunk) - Changes in tax laws or regulations, such as the OECD Pillar Two rules, could adversely affect the company's domestic and international business operations and financial performance[605](index=605&type=chunk)[606](index=606&type=chunk) [Item 2. Unregistered Sales of Equity Securities and Use of Proceeds](index=136&type=section&id=Item%202.%20Unregistered%20Sales%20of%20Equity%20Securities%20and%20Use%20of%20Proceeds) Climb Bio, Inc. reported no unregistered sales of equity securities or use of proceeds during the period covered by this Quarterly Report - No unregistered sales of equity securities or use of proceeds were reported for the period[607](index=607&type=chunk) [Item 3. Defaults Upon Senior Securities](index=136&type=section&id=Item%203.%20Defaults%20Upon%20Senior%20Securities) This item is not applicable to Climb Bio, Inc. for the current reporting period - This item is not applicable[608](index=608&type=chunk) [Item 4. Mine Safety Disclosures](index=136&type=section&id=Item%204.%20Mine%20Safety%20Disclosures) This item is not applicable to Climb Bio, Inc. for the current reporting period - This item is not applicable[609](index=609&type=chunk) [Item 5. Other Information](index=136&type=section&id=Item%205.%20Other%20Information) No Rule 10b5-1 or non-Rule 10b5-1 trading arrangements were adopted or terminated by directors or officers during Q2 2025 - No Rule 10b5-1 trading arrangements or non-Rule 10b5-1 trading arrangements were adopted or terminated by directors or officers during the three months ended June 30, 2025[610](index=610&type=chunk) [Item 6. Exhibits](index=137&type=section&id=Item%206.%20Exhibits) This section lists the exhibits filed as part of the Form 10-Q, including key agreements, certifications from executive officers, and XBRL documents - Exhibits include the Agreement and Plan of Merger and Reorganization, an Offer Letter, a Separation and Release of Claims Agreement, certifications of principal executive and financial officers, and Inline XBRL documents[613](index=613&type=chunk) [Signatures](index=138&type=section&id=Signatures) The Quarterly Report on Form 10-Q is signed by Climb Bio's President and CEO, Aoife Brennan, and SVP of Finance, Cindy Driscoll, on August 12, 2025 - The report is signed by Aoife Brennan, President and Chief Executive Officer (Principal Executive Officer), and Cindy Driscoll, Senior Vice President, Finance (Principal Financial Officer)[618](index=618&type=chunk) - The signing date for the report is August 12, 2025[618](index=618&type=chunk)

[Company Overview and Q2 2025 Highlights](index=1&type=section&id=Company%20Overview%20and%20Q2%202025%20Highlights) Climb Bio's Q2 2025 highlights include significant clinical trial advancements for budoprutug and CLYM116, alongside key leadership appointments, setting the stage for future data readouts [CEO Statement and Strategic Focus](index=1&type=section&id=CEO%20Statement) Climb Bio's CEO highlighted the company's focused execution, team building, and pipeline advancement, particularly noting patient dosing in ITP and SLE trials, regulatory clearance for pMN and subcutaneous budoprutug trials, and significant progress with CLYM116, setting the stage for a data-rich period - Patients have been dosed in both the ITP and SLE clinical trials of budoprutug, an anti-CD19 monoclonal antibody[3](index=3&type=chunk) - Regulatory clearance was achieved for the pMN Phase 2 trial and the Phase 1 trial of subcutaneous budoprutug in healthy volunteers, both expected to begin shortly[3](index=3&type=chunk) - CLYM116, a differentiated anti-APRIL antibody, is making exciting progress and is believed to be a best-in-class treatment for IgAN and other indications[3](index=3&type=chunk) - An investor event is planned for **September 2025** to showcase the CLYM116 program, share supportive preclinical data, and discuss IgAN development plans[3](index=3&type=chunk) [Second Quarter 2025 and Recent Highlights](index=1&type=section&id=Second%20Quarter%202025%20and%20Recent%20Highlights) The second quarter of 2025 saw significant advancements in Climb Bio's clinical pipeline, including the initiation of trials for budoprutug in ITP and SLE, progress towards a pMN trial, and the development of a subcutaneous formulation. The CLYM116 program also advanced towards clinical development, alongside a key corporate leadership appointment - Phase 1b/2a immune thrombocytopenia (ITP) trial and Phase 1b systemic lupus erythematosus (SLE) trial for budoprutug achieved First Patient In (FPI) and enrollment is ongoing[4](index=4&type=chunk) - Phase 2 primary membranous nephropathy (pMN) trial for budoprutug is on track to initiate in the coming weeks[4](index=4&type=chunk) - Budoprutug subcutaneous (SC) formulation demonstrated high bioavailability and favorable tolerability in non-clinical studies; a Phase 1 trial in healthy volunteers is expected to initiate soon, with initial results anticipated in the **first half of 2026**[5](index=5&type=chunk) - CLYM116 is advancing toward clinical development for IgA nephropathy (IgAN), with an IND or CTA submission expected in the **second half of 2025**[6](index=6&type=chunk) - Edgar D. Charles, M.D., MSc was appointed Chief Medical Officer in **June 2025**[7](index=7&type=chunk) [Pipeline Program Updates](index=1&type=section&id=Pipeline%20Program%20Updates) Climb Bio's pipeline is advancing with budoprutug trials in ITP, SLE, and pMN, a new subcutaneous formulation, and CLYM116 progressing towards clinical development for IgAN [Budoprutug Program Updates](index=1&type=section&id=Budoprutug%20Program%20Updates) Climb Bio provided updates on its budoprutug program, an anti-CD19 monoclonal antibody, detailing the ongoing clinical trials for ITP and SLE, the imminent initiation of a pMN trial, and the successful non-clinical development of a subcutaneous formulation [Immune Thrombocytopenia (ITP) Trial](index=1&type=section&id=Phase%201b%2F2a%20immune%20thrombocytopenia%20(ITP)%20trial) The Phase 1b/2a clinical trial for budoprutug in ITP patients is ongoing, evaluating safety, pharmacokinetics, and preliminary efficacy including B cell depletion and platelet counts - The Phase 1b/2a open-label, dose-escalation clinical trial of budoprutug in ITP patients has achieved FPI and enrollment is ongoing[4](index=4&type=chunk) - The trial evaluates safety, tolerability, pharmacokinetics, pharmacodynamics, and preliminary efficacy, including B cell depletion and platelet counts[4](index=4&type=chunk) [Systemic Lupus Erythematosus (SLE) Trial](index=1&type=section&id=Phase%201b%20systemic%20lupus%20erythematosus%20(SLE)%20trial) The Phase 1b clinical trial for budoprutug in SLE patients is enrolling, assessing safety, pharmacokinetics, and preliminary efficacy, including B cell depletion and autoantibody levels - The Phase 1b open-label, dose-escalation clinical trial of budoprutug in SLE patients has achieved FPI and enrollment is ongoing[4](index=4&type=chunk) - The trial evaluates safety, tolerability, pharmacokinetics, pharmacodynamics, and preliminary efficacy, including B cell depletion, autoantibody levels, and clinical activity[4](index=4&type=chunk) [Primary Membranous Nephropathy (pMN) Trial](index=1&type=section&id=Phase%202%20primary%20membranous%20nephropathy%20(pMN)%20trial) The Phase 2 pMN trial for budoprutug is set to begin soon, evaluating safety, pharmacokinetics, pharmacodynamics, and preliminary efficacy, including remission rates - The Phase 2 pMN trial, an open-label, dose-ranging study, is on track to initiate in the coming weeks[4](index=4&type=chunk) - The trial is designed to evaluate safety, pharmacokinetics, pharmacodynamics (including B cell depletion and anti-PLA2R antibody levels), and preliminary efficacy (including complete and partial remission)[4](index=4&type=chunk) [Subcutaneous (SC) Formulation Development](index=2&type=section&id=Continued%20development%20of%20subcutaneous%20(SC)%20formulation) Budoprutug's subcutaneous formulation shows high bioavailability and favorable tolerability in non-clinical data, with a Phase 1 trial in healthy volunteers expected to start soon - Supportive non-clinical data for budoprutug SC formulation demonstrated high bioavailability and favorable tolerability[5](index=5&type=chunk) - A Clinical Trial Application was cleared in Australia in August, and a Phase 1 trial in healthy volunteers is expected to initiate in the coming weeks[5](index=5&type=chunk) - Initial Phase 1 trial results for the budoprutug SC formulation are expected in the **first half of 2026**[5](index=5&type=chunk) [CLYM116 Program Updates](index=2&type=section&id=CLYM116%20Program%20Updates) Climb Bio's CLYM116 program, an anti-APRIL antibody for IgA nephropathy (IgAN), is progressing towards clinical development with an IND or CTA submission anticipated in the second half of 2025, complemented by an investor event in September 2025 to share preclinical data - CLYM116, an antibody targeting the APRIL pathway for IgA nephropathy (IgAN), is advancing toward clinical development[6](index=6&type=chunk) - Climb Bio remains on track to submit an Investigational New Drug (IND) or Clinical Trial Application (CTA) for CLYM116 in IgAN in the **second half of 2025**[6](index=6&type=chunk) - A CLYM116-focused investor event is planned for **September 2025** to share preclinical data, including head-to-head data in nonhuman primates with a first-generation anti-APRIL[6](index=6&type=chunk) [Corporate Developments](index=2&type=section&id=Corporate%20Developments) Climb Bio strengthened its leadership with the appointment of a new Chief Medical Officer, bringing extensive experience in immunology-focused pharmaceutical development [Chief Medical Officer Appointment](index=2&type=section&id=Appointed%20Edgar%20D.%20Charles%2C%20M.D.%2C%20MSc%20as%20Chief%20Medical%20Officer) Climb Bio strengthened its leadership team by appointing Edgar D. Charles, M.D., MSc as Chief Medical Officer in June 2025, leveraging his extensive experience in immunology-focused pharmaceutical development from previous roles at Bristol Myers Squibb and Merck & Co - Edgar D. Charles, M.D., MSc was appointed Chief Medical Officer in **June 2025**[7](index=7&type=chunk) - Dr. Charles brings over **20 years** of experience in immunology-focused pharmaceutical development, academic research, and clinical medicine[7](index=7&type=chunk) - He previously held significant clinical roles at Bristol Myers Squibb (BMS), leading immunology global program organization, and at Merck & Co., leading global clinical development programs[7](index=7&type=chunk) [Anticipated Milestones & Financial Summary](index=2&type=section&id=Anticipated%20Milestones%20and%20Financial%20Results%20Summary) Climb Bio anticipates key clinical and regulatory milestones for budoprutug and CLYM116 in H2 2025 and H1 2026, supported by a strong cash position extending through 2027 [Anticipated Milestones](index=2&type=section&id=Anticipated%20Milestones) Climb Bio outlined key upcoming milestones for its budoprutug and CLYM116 programs, including trial initiations, data readouts, and regulatory submissions, primarily concentrated in the second half of 2025 and first half of 2026 - Budoprutug (anti-CD19 monoclonal antibody) milestones[11](index=11&type=chunk) - pMN Phase 2 study – first patient in (**H2 2025**)[11](index=11&type=chunk) - Company to provide guidance on the anticipated timing of clinical readouts in SLE and ITP (**H2 2025**)[11](index=11&type=chunk) - Subcutaneous formulation Phase 1 clinical trial in healthy volunteers – first patient in (**H2 2025**) and initial results (**H1 2026**)[11](index=11&type=chunk) - CLYM116 (anti-APRIL monoclonal antibody) milestones[11](index=11&type=chunk) - Reporting preclinical data (**September 2025**) and submission of IND or CTA in IgAN (**H2 2025**)[11](index=11&type=chunk) - Investor event on CLYM116 to be held in **September 2025**[11](index=11&type=chunk) [Second Quarter 2025 Financial Highlights](index=2&type=section&id=Second%20Quarter%202025%20Financial%20Results) Climb Bio reported a strong cash position expected to fund operations through 2027, alongside increased R&D and G&A expenses for Q2 2025 compared to the prior year, while net loss significantly decreased due to the absence of acquired IPR&D expenses - Cash, cash equivalents and marketable securities were **$187.4 million** as of **June 30, 2025**, expected to fund operations through **2027**[11](index=11&type=chunk) Operating Expenses and Net Loss (Three Months Ended June 30) | Metric | Q2 2025 (in thousands) | Q2 2024 (in thousands) | Change (YoY) | | :-------------------------------- | :--------------------- | :--------------------- | :------------- | | Research and Development (R&D) | $6,575 | $1,046 | +$5,529 | | Acquired In-Process R&D | $0 | $51,659 | -$51,659 | | General and Administrative (G&A) | $4,102 | $3,667 | +$435 | | Other income, net | $2,011 | $1,483 | +$528 | | Net Loss | $(8,666) | $(54,889) | +$46,223 | | Net loss per share, basic and diluted | $(0.13) | $(1.81) | +$1.68 | [About Climb Bio and Product Information](index=2&type=section&id=About%20Climb%20Bio%2C%20Inc.) Climb Bio is a clinical-stage biotech company focused on immune-mediated diseases, developing budoprutug (anti-CD19) and CLYM116 (anti-APRIL) with distinct mechanisms of action [Company Profile](index=2&type=section&id=About%20Climb%20Bio%2C%20Inc.%20(Company%20Description)) Climb Bio, Inc. is a clinical-stage biotechnology company dedicated to developing therapeutics for patients with immune-mediated diseases, with a pipeline featuring budoprutug and CLYM116 - Climb Bio, Inc. is a clinical-stage biotechnology company developing therapeutics for patients with immune-mediated diseases[10](index=10&type=chunk) - The company's pipeline includes budoprutug, an anti-CD19 monoclonal antibody, and CLYM116, an anti-APRIL monoclonal antibody[10](index=10&type=chunk) [About Budoprutug](index=4&type=section&id=About%20Budoprutug) Budoprutug is a clinical-stage anti-CD19 monoclonal antibody designed to deplete B cells, targeting a broad range of B-cell mediated immune diseases, with ongoing trials in pMN, ITP, and SLE, and a subcutaneous formulation under development to enhance patient access - Budoprutug is a clinical-stage, anti-CD19 monoclonal antibody developed to address a broad range of B-cell mediated, immune-driven diseases[12](index=12&type=chunk) - It targets and depletes CD19-expressing B cells, including plasma blasts, which are key sources of pathogenic autoantibodies[12](index=12&type=chunk) - Climb Bio plans to evaluate budoprutug in multiple clinical trials across three lead indications: primary membranous nephropathy (pMN), immune thrombocytopenia (ITP), and systemic lupus erythematosus (SLE)[12](index=12&type=chunk) - Early clinical data suggest durable B-cell depletion, rapid reductions in autoantibodies, and clinical remission in pMN[12](index=12&type=chunk) - A subcutaneous formulation is in development to enable broader patient access and potential home-based dosing, and it has been granted orphan drug designation by the FDA for pMN[12](index=12&type=chunk) [About CLYM116](index=4&type=section&id=About%20CLYM116) CLYM116 is a preclinical-stage anti-APRIL monoclonal antibody with a novel pH-dependent mechanism, designed for potent, durable inhibition of APRIL with less frequent dosing, primarily being advanced for IgA nephropathy (IgAN) with potential for broader utility - CLYM116 is a preclinical-stage monoclonal antibody targeting APRIL (A Proliferation-Inducing Ligand), a key driver of pathogenic B-cell activity in autoimmune diseases[13](index=13&type=chunk) - It employs a novel pH-dependent bind-and-release mechanism to potently block APRIL signaling, promote lysosomal degradation of APRIL, and recycle the antibody to extend its half-life[13](index=13&type=chunk) - This differentiated design offers the potential for rapid, deep, and durable inhibition of APRIL with a favorable safety profile and less frequent dosing[13](index=13&type=chunk) - CLYM116 is being advanced for the treatment of IgA nephropathy (IgAN), with plans to initiate a Phase 1 clinical trial following IND-enabling studies and regulatory clearance[13](index=13&type=chunk) [Financial Statements](index=6&type=section&id=Financial%20Statements) Climb Bio's financial statements for Q2 2025 reflect a reduced net loss compared to the prior year, primarily due to the absence of acquired IPR&D expenses, alongside a decrease in cash and total assets [Condensed Consolidated Balance Sheets](index=6&type=section&id=Condensed%20Consolidated%20Balance%20Sheets) The condensed consolidated balance sheets show Climb Bio's financial position as of June 30, 2025, reflecting a decrease in cash, cash equivalents, and marketable securities, leading to a reduction in total assets and stockholders' equity compared to December 31, 2024, while total liabilities slightly increased Condensed Consolidated Balance Sheet Highlights (in thousands) | Metric | June 30, 2025 | December 31, 2024 | Change | | :-------------------------------- | :------------ | :---------------- | :----- | | Cash, cash equivalents and marketable securities | $187,405 | $212,529 | -$25,124 | | Other assets | $4,981 | $4,658 | +$323 | | Total assets | $192,386 | $217,187 | -$24,801 | | Liabilities | $6,622 | $5,306 | +$1,316 | | Total stockholders' equity | $185,764 | $211,881 | -$26,117 | | Total liabilities and stockholders' equity | $192,386 | $217,187 | -$24,801 | [Condensed Consolidated Statements of Operations](index=6&type=section&id=Condensed%20Consolidated%20Statements%20of%20Operations) Climb Bio's statements of operations for Q2 2025 show a significant decrease in net loss compared to Q2 2024, primarily due to the absence of a large acquired in-process R&D expense from the prior year, despite an increase in ongoing R&D and G&A expenses Condensed Consolidated Statements of Operations (Three Months Ended June 30, in thousands, except per share amounts) | Metric | 2025 | 2024 | Change (YoY) | | :-------------------------------- | :--- | :--- | :----------- | | Research and development | $6,575 | $1,046 | +$5,529 | | Acquired in-process research and development | $0 | $51,659 | -$51,659 | | General and administrative | $4,102 | $3,667 | +$435 | | Total operating expenses | $10,677 | $56,372 | -$45,695 | | Loss from operations | $(10,677) | $(56,372) | +$45,695 | | Other income, net | $2,011 | $1,483 | +$528 | | Net loss | $(8,666) | $(54,889) | +$46,223 | | Net loss per share, basic and diluted | $(0.13) | $(1.81) | +$1.68 | Condensed Consolidated Statements of Operations (Six Months Ended June 30, in thousands, except per share amounts) | Metric | 2025 | 2024 | Change (YoY) | | :-------------------------------- | :--- | :--- | :----------- | | Research and development | $23,902 | $2,137 | +$21,765 | | Acquired in-process research and development | $0 | $51,659 | -$51,659 | | General and administrative | $9,793 | $5,581 | +$4,212 | | Total operating expenses | $33,695 | $59,377 | -$25,682 | | Loss from operations | $(33,695) | $(59,377) | +$25,682 | | Other income, net | $4,248 | $2,791 | +$1,457 | | Net loss | $(29,447) | $(56,586) | +$27,139 | | Net loss per share, basic and diluted | $(0.44) | $(1.95) | +$1.51 | [Legal and Contact Information](index=4&type=section&id=Legal%20and%20Contact%20Information) This section provides important disclaimers regarding forward-looking statements, highlighting inherent risks and uncertainties, and offers contact details for investor and media inquiries [Forward-Looking Statements](index=4&type=section&id=Forward-Looking%20Statements) This section serves as a cautionary note, indicating that the press release contains forward-looking statements subject to various risks and uncertainties that could cause actual results to differ materially from expectations, and Climb Bio disclaims any obligation to update these statements unless legally required - The press release contains "forward-looking statements" regarding future expectations, plans, and prospects for Climb Bio, including therapeutic benefits, clinical development, trial timelines, and financial resources[14](index=14&type=chunk) - These statements are subject to risks and uncertainties that could cause actual results to differ materially, including those related to acquisitions, regulatory changes, competition, intellectual property, expense management, and capital raising[14](index=14&type=chunk) - Climb Bio specifically disclaims any obligation to update these forward-looking statements, except as required by law[14](index=14&type=chunk) [Investors and Media Contact](index=4&type=section&id=Investors%20and%20Media) Contact information is provided for investors and media inquiries, directing them to Carlo Tanzi, Ph.D. at Kendall Investor Relations - For investor and media inquiries, contact Carlo Tanzi, Ph.D. at Kendall Investor Relations[15](index=15&type=chunk) - Email: ctanzi@kendallir.com[15](index=15&type=chunk)

Core Insights - Climb Bio, Inc. is advancing its clinical pipeline with ongoing trials for budoprutug in immune thrombocytopenia (ITP) and systemic lupus erythematosus (SLE), and plans to initiate a trial for primary membranous nephropathy (pMN) soon [1][3][4] - The company has a strong financial position, with cash reserves expected to fund operations through 2027 [1][10] Budoprutug Program Updates - Budoprutug, an anti-CD19 monoclonal antibody, is currently in Phase 1b/2a trials for ITP and SLE, with enrollment ongoing [6][12] - The pMN Phase 2 trial is set to begin in the coming weeks, focusing on safety and preliminary efficacy [6][12] - A subcutaneous formulation of budoprutug has shown high bioavailability and favorable tolerability in non-clinical studies, with a Phase 1 trial expected to start shortly [1][6] CLYM116 Program Updates - CLYM116, an anti-APRIL monoclonal antibody, is progressing towards clinical development for IgA nephropathy (IgAN), with an IND or CTA submission anticipated in the second half of 2025 [5][14] - An investor event is planned for September 2025 to present new preclinical data on CLYM116 [1][5] Corporate Updates - Edgar D. Charles, M.D., MSc has been appointed as Chief Medical Officer, bringing over 20 years of experience in immunology-focused pharmaceutical development [8] - The company reported a net loss of $8.7 million for the second quarter of 2025, compared to a loss of $54.9 million in the same period of 2024 [10][19] Financial Highlights - As of June 30, 2025, Climb Bio had cash, cash equivalents, and marketable securities totaling $187.4 million [10][17] - Research and development expenses for the second quarter of 2025 were $6.6 million, significantly higher than $1.0 million in the same period of 2024 [10][19]

Core Insights - Climb Bio, Inc. has appointed Dr. Edgar D. Charles as Chief Medical Officer and Cindy J. Driscoll as Senior Vice President, Finance, enhancing its leadership team at a crucial time for the company [1][2] Leadership Appointments - Dr. Charles brings over 20 years of experience in immunology-focused pharmaceutical development, having previously held significant roles at Bristol Myers Squibb, where he led the development of various therapeutic candidates [2][3] - Cindy Driscoll has over two decades of experience in financial and administrative functions within the biopharma sector, previously serving as Senior Vice President of Finance at HC Bioscience [2][4] Clinical Development Focus - The company is focused on advancing its clinical studies for budoprutug and CLYM116, with Dr. Charles emphasizing the therapeutic potential of budoprutug in treating serious diseases where B cells are central to pathology [4][7] - Budoprutug is an anti-CD19 monoclonal antibody that has shown promise in B cell depletion, while CLYM116 is an anti-APRIL monoclonal antibody currently in IND-enabling studies for IgA nephropathy [7] Inducement Equity Awards - Climb Bio has granted inducement equity awards to Dr. Charles and Ms. Driscoll, including stock options to purchase 600,000 and 200,000 shares of common stock, respectively, with an exercise price of $1.20 per share [5][6]

Core Points - Climb Bio, Inc. has granted an inducement equity award to a new employee as part of its 2025 Inducement Plan [1] - The inducement equity award consists of a non-statutory stock option for 120,000 shares at an exercise price of $1.27 per share, with a ten-year term and a four-year vesting schedule [2] - Climb Bio is focused on developing therapeutics for immune-mediated diseases, with a pipeline that includes budoprutug and CLYM116 [3] Summary by Category Inducement Equity Award - The inducement equity award was granted on May 19, 2025, to one new employee [2] - The stock option allows the purchase of up to 120,000 shares at an exercise price equal to the closing price on the grant date [2] - The vesting schedule includes 25% vesting on the first anniversary and the remainder vesting in 36 equal monthly installments [2] Company Overview - Climb Bio, Inc. is a clinical-stage biotechnology company [3] - The company is developing therapeutics for patients with immune-mediated diseases [3] - Key products in the pipeline include budoprutug, an anti-CD19 monoclonal antibody, and CLYM116, an anti-APRIL monoclonal antibody [3]

Financial Performance - Climb Bio, Inc. reported a net loss of $20.8 million for Q1 2025, compared to a net loss of $1.7 million for Q1 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, compared to $3.0 million in Q1 2024, reflecting a 666.0% increase[150]. - The net loss for Q1 2025 was $20.8 million, significantly higher than the $1.7 million loss in Q1 2024, marking an increase of 1124.6%[150]. - Net cash used in operating activities for Q1 2025 was $15.4 million, compared to $1.8 million in Q1 2024[164]. - Net cash used in investing activities for Q1 2025 was $42.8 million, primarily due to $58.8 million in marketable securities purchases[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]. Cash and Funding - The company has cash, cash equivalents, and marketable securities of $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]. Research and Development - Research and development expenses for Q1 2025 totaled $17.3 million, a significant increase from $1.1 million in Q1 2024[140]. - Climb Bio, Inc. anticipates substantial increases in research and development expenses as it conducts ongoing clinical trials and studies[142]. - The company has paused the development of its Kv7 program, previously focused on neuronal excitability disorders, while seeking a partner for further development[126]. - The Mabworks Agreement for CLYM116 included an upfront payment of $9.0 million, with additional milestone payments and royalties expected[134]. - 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]. Product Development - Budoprutug, the cornerstone product candidate, showed a 60% complete remission rate in a Phase 1b trial for primary membranous nephropathy (pMN)[124]. - Climb Bio, Inc. received FDA clearance for a Phase 2 clinical trial of budoprutug in pMN, with patient dosing anticipated in the second half of 2025[124]. - The company is also developing CLYM116, with preclinical data expected in the second half of 2025 and an IND submission planned for the same period[125]. Corporate Actions - The acquisition of Tenet Medicines, Inc. was completed for $52.8 million, including $41.9 million in common stock and $10.8 million in transaction costs and loans[133]. Administrative Expenses - General and administrative expenses rose from $1.9 million in Q1 2024 to $5.7 million in Q1 2025, an increase of 197.3%[152]. Company Classification - 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].