Dr. Charles brings over 20 years of experience in immunology-focused pharmaceutical development, academic research, and clinical medicine to the role. He joins Climb Bio from Bristol Myers Squibb (BMS), where he held clinical roles of increasing responsibility since joining in 2015, leading the development of numerous therapeutic candidates through IND, Phase 1-4 clinical trials, and FDA product approval. Dr. Charles most recently served as Vice President and Senior Global Program Lead, Immunology at BMS, w ...

WELLESLEY HILLS, Mass., May 19, 2025 (GLOBE NEWSWIRE) -- Climb Bio, Inc. (Nasdaq: CLYM), a clinical-stage biotechnology company developing therapeutics for patients with immune-mediated diseases, today announced that the Company has granted an inducement equity award to a new employee, pursuant to the Company’s 2025 Inducement Plan, as an inducement material to the new employee entering into employment with the Company in accordance with Nasdaq Listing Rule 5635(c)(4). The inducement equity award was grante ...

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].

Financial Performance - Climb Bio reported cash, cash equivalents, and marketable securities of $197.8 million as of March 31, 2025, expected to fund operations through 2027[8] - Research and Development (R&D) expenses for Q1 2025 were $17.3 million, significantly up from $1.1 million in Q1 2024[8] - General and Administrative (G&A) expenses for Q1 2025 were $5.7 million, compared to $1.9 million in Q1 2024[8] - The net loss for Q1 2025 was $20.8 million, with a net loss per share of $0.31, compared to a net loss of $1.7 million and $0.06 per share in Q1 2024[8] Clinical Trials and Regulatory Approvals - Climb Bio received FDA clearance for a Phase 2 clinical trial of budoprutug in primary membranous nephropathy (pMN) and a Phase 1b/2a trial in immune thrombocytopenia (ITP) in March 2025[4] - The company plans to initiate clinical studies for budoprutug in ITP and systemic lupus erythematosus (SLE) in the coming weeks, with pMN studies expected to start in the second half of 2025[3] - Climb Bio is pursuing regulatory clearance for budoprutug clinical trials in SLE outside the United States[4] Pipeline and Development Plans - Climb Bio's pipeline includes budoprutug and CLYM116, targeting immune-mediated diseases with significant therapeutic potential[7] - Climb Bio is advancing the CLYM116 program, with plans to submit an investigational new drug (IND) or clinical trial application (CTA) by year-end 2025[3] Leadership Changes - The company appointed Kim Cobleigh Drapkin and Bo Cumbo as Independent Directors, and Perrin Wilson, Ph.D., as Chief Business Officer in 2025[8]

Core Insights - Climb Bio, Inc. has appointed Kim Cobleigh Drapkin and Bo Cumbo as independent directors, enhancing its leadership team with experienced professionals from the biotechnology sector [1][2][3] Company Developments - Kim Cobleigh Drapkin will serve as the Audit Committee Chair, while Bo Cumbo will take on the role of Compensation Committee Chair [1] - The appointments are expected to provide valuable insights as Climb Bio advances its pipeline and transitions into a late-stage, pre-commercial company focused on immune-mediated diseases [2] Leadership Background - Kim Cobleigh Drapkin has over 30 years of experience in the biotechnology and pharmaceutical industries, previously serving as CEO of Graphite Bio and CFO at Jounce Therapeutics [2][3] - Bo Cumbo also brings over 30 years of experience, having led successful commercial launches for 11 specialty and rare disease therapies, and currently serves as CEO of Solid Biosciences [3] Board Changes - Simon Tate will step down from the Board, and Adam Rosenberg will not seek re-election at the 2025 Annual Meeting of Stockholders [4] Company Overview - Climb Bio is a clinical-stage biotechnology company developing therapeutics for immune-mediated diseases, with a pipeline that includes budoprutug and CLYM116 [5]

Core Insights - Climb Bio, Inc. will participate in the 24th Annual Needham Healthcare Conference, which will be held virtually from April 7-10, 2025 [1] - The conference will include presentations and one-on-one investor meetings, with Climb Bio's presentation scheduled for April 10, 2025, at 8:45 a.m. ET [2] Company Overview - Climb Bio, Inc. is a clinical-stage biotechnology company focused on developing therapeutics for immune-mediated diseases [2] - The company's pipeline includes budoprutug, an anti-CD19 monoclonal antibody that has shown B-cell depletion and potential applications for a variety of 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]

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].

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]

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].

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]