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Climb Bio, Inc(CLYM) - 2024 Q4 - Annual Results
2025-03-25 20:46
Equity Distribution Agreement - Climb Bio, Inc. has entered into an equity distribution agreement with Oppenheimer & Co. Inc. for the issuance and sale of common stock[1]. - Climb Bio, Inc. has entered into an Equity Distribution Agreement with Oppenheimer & Co. Inc. for the sale of common stock[159]. - The Company will pay Oppenheimer & Co. a cash compensation of up to 3.0% of the gross proceeds from the sales of Placement Shares[162]. - The Agreement allows for the sale of shares at a minimum market price, with specific limits on the number of shares sold in a single trading day[159]. - The Company certifies that all representations and warranties in the Agreement are true and correct as of the date of the certificate[165]. - Climb Bio, Inc. has complied with all agreements and satisfied all conditions required by the Agreement[166]. - The Agreement is executed in counterparts, which are deemed original and valid for all purposes[152]. - The Company may not disclose any information gained in connection with the Agreement to third parties without written approval[153]. - The Agreement is governed by U.S. federal laws, including the ESIGN Act and the Uniform Electronic Transactions Act[152]. - The Company is represented by legal counsel in connection with the Agreement and its transactions[153]. - The Agreement includes provisions for electronic delivery and signatures, ensuring validity and effectiveness[152]. Common Stock Issuance - The company may issue and sell shares of common stock with a par value of $0.0001 per share, subject to certain limitations[1]. - The registration statement for the common stock was filed and declared effective by the SEC on November 22, 2024[2]. - The company will provide a prospectus supplement specifically related to the placement shares to be issued under this agreement[2]. - Each placement will require a notice to the agent detailing the maximum number of shares to be sold and the time period for sales[4]. - The agent will use commercially reasonable efforts to sell the placement shares as specified in the placement notice[6]. - Settlement for sales of placement shares will occur on the first trading day following the date of sale[10]. - The net proceeds delivered to the company will equal the aggregate gross sales price minus the agent's commission[10]. - The company is responsible for delivering freely tradeable shares on the settlement date[11]. - In case of default in delivering shares, the company must return the net proceeds to the agent by 5:00 P.M. on the settlement date[12]. - The Company has filed a Registration Statement with the Commission, which has been declared effective prior to the issuance of Placement Notices[15]. - The Placement Shares have been duly authorized for issuance and will be validly issued and fully paid when delivered[30]. - The Company has filed a Notification of Listing of Additional Shares with Nasdaq regarding the Placement Shares[24]. - The Company has the authorized and outstanding capitalization as set forth in its most recent annual report[29]. - The Company will file a prospectus supplement with the Commission detailing the number of Placement Shares sold and the Net Proceeds to the Company[86]. - The Company will not offer or sell any shares of Common Stock without the prior written consent of the Agent during specified trading periods[83]. Compliance and Regulatory Matters - The Company is not an "ineligible issuer" and has not been a shell company for at least 12 months[19]. - The Company is classified as an "emerging growth company" under the Securities Act[20]. - The Company has complied with the reporting requirements of the Exchange Act and its Common Stock is listed on Nasdaq[24]. - The Company has not distributed any offering material other than the Registration Statement and Prospectus[22]. - The interactive data in eXtensible Business Reporting Language included in the Registration Statement fairly presents the required information[23]. - The Company has taken all necessary corporate actions for the execution and delivery of the Agreement[28]. - The Company has timely prepared and filed all required tax returns and paid all material taxes owed, except those being contested in good faith[36]. - The Company possesses adequate licenses and permits necessary to conduct its business, with no known proceedings threatening their revocation[38]. - The Company and its Subsidiaries own all necessary intellectual property rights for their business operations, with no known infringements by third parties[40]. - All clinical trials and studies for Company Regulated Products have been conducted in compliance with applicable laws and regulations[46]. - The Company has not received any notices from regulatory authorities alleging non-compliance with applicable laws regarding Company Regulated Products[43]. - The Company has not been debarred or disqualified from participating in clinical trials or federal health care programs[47]. - The Company has maintained good and marketable title to all properties and assets owned, free from liens and encumbrances[37]. - There are no legal or regulatory investigations pending that would reasonably be expected to have a Material Adverse Effect on the Company[50]. - The Company has not engaged in dealings with any Sanctioned Persons or in Sanctioned Countries since April 24, 2019[59]. - The Company has complied with anti-bribery and anti-money laundering laws in all jurisdictions where it operates[56]. - The Company must ensure compliance with all material environmental permits and conduct its business in substantial compliance with applicable Environmental Laws[7(s)]. Financial Reporting and Internal Controls - The financial statements present fairly the consolidated financial position of the Company and its Subsidiaries, prepared in compliance with GAAP[51]. - The Company and its Subsidiaries maintain a system of internal control over financial reporting that provides reasonable assurance regarding the reliability of financial reporting[53]. - There are no material weaknesses in the Company's internal controls over financial reporting[53]. - The Company is insured against customary losses and risks, with all insurance policies in full force and effect[62]. - The Company has not incurred any material liability under ERISA with respect to employee benefit plans[66]. - The Company will make generally available to its security holders an earnings statement covering a 12-month period not later than 15 months after the end of the current fiscal quarter[80]. - The Company will pay all expenses related to the preparation, filing, and delivery of the Registration Statement and Prospectus, including legal fees not to exceed $75,000 for executing the Agreement[81]. - The Company will file all required reports and definitive proxy statements with the Commission in a timely manner[76]. Indemnification and Termination - The Company agrees to indemnify the Agent and its affiliates against any losses or claims arising from untrue statements or omissions in the Registration Statement or Prospectus[119]. - The Agent agrees to indemnify the Company against losses related to untrue statements or omissions made in reliance on the Agent's Information[120]. - The Company and the Agent will contribute to total losses in proportion to the benefits received from the sale of Placement Shares[125]. - The indemnity and contribution agreements will survive regardless of any investigations or the delivery of Placement Shares[127]. - The Company has the right to terminate the Agreement at any time with ten days' prior written notice, effective at 4:05 P.M. New York City Time on the tenth day following receipt of such notice[129]. - The Agent can terminate the Agreement if a Material Adverse Effect occurs that may impair the ability to sell Placement Shares[128]. - Any termination of the Agreement shall not incur liability for any party, except for certain provisions that remain in effect[133]. - The Agreement will remain in full force unless terminated by mutual agreement or as specified in Sections 11(a), (b), or (c)[132]. Miscellaneous Provisions - Notices must be in writing and delivered to specified addresses for both the Agent and the Company[134]. - The Agreement is governed by the laws of the State of New York, and both parties waive the right to a jury trial[141]. - The Company acknowledges that no fiduciary relationship is created between the Company and the Agent in connection with the transactions contemplated by the Agreement[147]. - The Company is responsible for its own legal, accounting, and tax advice regarding the transactions[147]. - The Agreement includes provisions for adjustments related to share splits or similar events[138].
Climb Bio Reports Fourth Quarter and Year-End 2024 Financial Results and Provides Business Updates
Globenewswire· 2025-03-25 20:05
Core Insights - Climb Bio, Inc. has received FDA clearance for clinical trials of its lead asset, budoprutug, targeting primary membranous nephropathy (pMN), immune thrombocytopenia (ITP), and systemic lupus erythematosus (SLE) [1][3] - The company has expanded its pipeline to include CLYM116, an anti-APRIL monoclonal antibody for IgA nephropathy (IgAN) [2][3] - Climb Bio ended 2024 with a strong financial position, reporting cash and equivalents of $212.5 million, expected to fund operations through 2027 [6][12] Company Developments - Climb Bio appointed Perrin Wilson, Ph.D. as Chief Business Officer, bringing over 17 years of experience in the pharmaceutical and biotech industry [4] - The company has initiated clinical trials for budoprutug in pMN and ITP, with plans to dose the first patients in the second half of 2025 and the first half of 2025, respectively [2][7] - CLYM116 is currently in IND-enabling studies, with initial preclinical data expected to be shared in the second half of 2025 [2][3] Financial Performance - For the year ended December 31, 2024, Climb Bio reported a net loss of $73.9 million, which included $51.7 million in acquired in-process research and development expenses [6][14] - Research and development expenses for the full year 2024 were $14.3 million, compared to $15.4 million in 2023 [6][14] - General and administrative expenses for the full year 2024 were $16.0 million, down from $24.9 million in 2023 [6][14]
Climb Bio, Inc(CLYM) - 2024 Q4 - Annual Report
2025-03-25 20:01
Financial Performance - The company incurred net losses of $73.9 million and $35.1 million for the years ended December 31, 2024 and 2023, respectively, with an accumulated deficit of $229.9 million as of December 31, 2024[710]. - The company has not generated any revenue from product sales since inception and anticipates continued operating losses for the foreseeable future[715]. - Total operating expenses increased by 103.6% from $40.3 million in 2023 to $82.0 million in 2024, primarily due to a $51.7 million expense related to acquired in-process research and development[736][737]. - The accumulated deficit increased from $156.0 million in 2023 to $229.9 million in 2024[744]. Cash and Investments - The company had cash, cash equivalents, and marketable securities of $212.5 million as of December 31, 2024, sufficient to fund operations through 2027 based on current estimates[711]. - As of December 31, 2024, cash, cash equivalents, and marketable securities totaled $212.5 million, up from $106.8 million in 2023[744]. - Net cash used in operating activities was $15.6 million in 2024, compared to $20.6 million in 2023, reflecting a net loss of $73.9 million[752][753]. - Net cash used in investing activities was $121.1 million in 2024, primarily due to purchases of marketable securities totaling $132.2 million[754]. - Net cash provided by financing activities was $130.7 million in 2024, mainly from the issuance of common stock in a private placement[757]. Research and Development - Research and development expenses totaled $65.995 million for the year ended December 31, 2024, a significant increase from $15.411 million in 2023[726]. - Budoprutug, the company's cornerstone product candidate, showed a 60% complete remission rate in a Phase 1b clinical trial for primary membranous nephropathy[707]. - The company plans to initiate clinical trials for budoprutug in immune thrombocytopenia and systemic lupus erythematosus in the first half of 2025[707]. - CLYM116, a preclinical stage anti-APRIL monoclonal antibody, is expected to announce preclinical data in the second half of 2025[708]. - The company expects substantial increases in research and development expenses as it conducts ongoing clinical trials and studies[728]. Expenses and Cost Management - General and administrative expenses decreased by 35.5% from $24.9 million in 2023 to $16.0 million in 2024, driven by a reduction in personnel-related expenses[741]. - Research and development expenses decreased by 8% from $15.4 million in 2023 to $14.2 million in 2024, while total research and development expenses, including related party, decreased by 7%[738][739]. - The company incurred restructuring costs of $3.3 million related to a workforce reduction in the UK, fully recognized by December 31, 2024[718]. - The company anticipates that expenses will continue to increase as it advances product candidates and expands corporate infrastructure[746]. Internal Controls and Compliance - The company identified material weaknesses in internal control over financial reporting, with two remaining unremediated as of December 31, 2024[766]. - The company is classified as an emerging growth company under the JOBS Act, allowing it to delay adopting new accounting standards until they apply to private companies[767]. - The company will remain an emerging growth company until it achieves total annual gross revenue of $1.24 billion or more, issues more than $1.0 billion of non-convertible debt, or meets other specified criteria[768]. - Stock-based compensation is measured based on estimated grant-date fair value, using the Black-Scholes option pricing model, which involves significant assumptions that can materially affect reported expenses[764]. - The company is not required to provide quantitative and qualitative disclosures about market risk as a smaller reporting company[769]. Income and Interest - Interest income, net increased by 76% from $4.6 million in 2023 to $8.1 million in 2024, attributed to an increase in marketable securities[743].
Climb Bio to Present at Upcoming Investor Conferences
Globenewswire· 2025-02-25 12:00
Company Overview - Climb Bio, Inc. is a clinical-stage biotechnology company focused on developing therapeutics for patients with immune-mediated diseases [2] - The company's pipeline includes budoprutug, an anti-CD19 monoclonal antibody, which has shown B-cell depletion and potential to treat various B-cell mediated diseases [2] - Another key product in development is CLYM116, an anti-APRIL monoclonal antibody currently undergoing IND-enabling studies for IgA nephropathy [2] Upcoming Investor Conferences - Climb Bio's executive team will participate in the TD Cowen 45 Annual Health Care Conference on March 4, 2025, at 9:50 a.m. ET, featuring formal presentations and one-on-one investor meetings [2] - The company will also be present at Leerink's Global Healthcare Conference 2025 on March 10, 2025, at 10:00 a.m. ET, which will include a fireside chat and one-on-one investor meetings [2]
Climb Bio Appoints Perrin Wilson, Ph.D., as Chief Business Officer
Globenewswire· 2025-02-24 12:00
Core Insights - Climb Bio, Inc. has appointed Dr. Perrin Wilson as Chief Business Officer, bringing over 17 years of experience in the pharmaceutical and biotech industry [1][2] - Dr. Wilson will lead pre-commercial planning, communications, and business development efforts, focusing on advancing treatments for immune-mediated diseases [2] - The company is currently developing two key assets: budoprutug, an anti-CD19 monoclonal antibody, and CLYM116, an anti-APRIL monoclonal antibody for IgA nephropathy [3] Company Overview - Climb Bio, Inc. is a clinical-stage biotechnology company focused on therapeutics for patients with immune-mediated diseases [3] - The pipeline includes budoprutug, which has shown B-cell depletion potential, and CLYM116, which is in IND-enabling studies [3] Leadership Background - Dr. Wilson previously served as Senior Vice President at Nuvalent and held various roles at Forma Therapeutics/Novo Nordisk, including leading a $1.1 billion acquisition [2] - She has extensive experience in business development and strategy, including a $5.2 billion acquisition at Takeda [2]
Climb Bio to Present at the Oppenheimer 35th Annual Healthcare Life Sciences Conference
Newsfilter· 2025-02-04 12:00
Company Overview - Climb Bio, Inc. is a clinical-stage biotechnology company focused on developing therapeutics for patients with immune-mediated diseases [2] - The company's pipeline includes budoprutug, an anti-CD19 monoclonal antibody, and CLYM116, an anti-APRIL monoclonal antibody [2] Upcoming Event - Members of Climb Bio's executive team will participate in the Oppenheimer 35th Annual Healthcare Life Sciences Conference on February 11-12, 2025 [1] - The presentation is scheduled for February 12, 2025, at 9:20 a.m. ET [2]
Climb Bio Expands Pipeline Through an Exclusive License to Develop and Commercialize an Antibody Targeting the APRIL Pathway for IgA Nephropathy
Globenewswire· 2025-01-09 12:00
Transaction Expands Climb Bio’s Pipeline of B-cell Targeted Therapeutics to Address Immune-mediated Diseases New Program is a Highly Potent, Fc-engineered anti-APRIL Monoclonal Antibody Specifically Designed to Address Patient Needs Preclinical Data Expected to be Shared Later in 2025 WELLESLEY HILLS, Mass., Jan. 09, 2025 (GLOBE NEWSWIRE) -- Climb Bio, Inc. (Nasdaq: CLYM) today announced it has entered into an exclusive license agreement with Beijing Mabworks Biotech Co., Ltd. (NEEQ Code: 874070, Mabworks) ...
Climb Bio, Inc(CLYM) - 2024 Q3 - Quarterly Results
2024-11-12 21:05
Exhibit 99.2 UNAUDITED PRO FORMA CONDENSED COMBINED STATEMENTS OF OPERATIONS On June 27, 2024 (the "Closing Date"), Climb Bio, Inc. (the "Company" or "Climb"), formerly known as Eliem Therapeutics, Inc., completed its acquisition of Tenet Medicines, Inc., a Delaware corporation ("Tenet"), pursuant to the terms of the Agreement and Plan of Merger and Reorganization, dated as of April 10, 2024 (the "Acquisition Agreement"), by and among the Company, Tango Merger Sub, Inc., a Delaware corporation and a wholly ...
Climb Bio Reports Third Quarter 2024 Financial Results and Business Highlights
GlobeNewswire News Room· 2024-11-12 21:05
Appointed Douglas Williams, Ph.D. as Chair of the Board of Directors FDA Clearance of Investigational New Drug Application (IND) for systemic lupus erythematosus (SLE) Expanded Management Team with the Appointment of Gary Hao, Ph.D. as Vice President of Chemistry, Manufacturing and Controls Highlights Timing of Key Upcoming Milestones Cash Runway Remains through 2027 Expected to Enable Delivery of Key Value Inflection Points WELLESLEY HILLS, Mass., Nov. 12, 2024 (GLOBE NEWSWIRE) -- Climb Bio, Inc. (Nasdaq: ...
Climb Bio, Inc(CLYM) - 2024 Q3 - Quarterly Report
2024-11-12 21:00
UNITED STATES SECURITIES AND EXCHANGE COMMISSION WASHINGTON, DC 20549 Title of each class Trading Symbol(s) Name of each exchange on which registered FORM 10-Q (Mark One) ☒ QUARTERLY REPORT PURSUANT TO SECTION 13 OR 15(d) OF THE SECURITIES EXCHANGE ACT OF 1934 For the quarterly period ended September 30, 2024 OR ☐ TRANSITION REPORT PURSUANT TO SECTION 13 OR 15(d) OF THE SECURITIES EXCHANGE ACT OF 1934 For the transition period from to Commission File Number: 001-40708 CLIMB BIO, INC. (Exact Name of Registra ...