Core Viewpoint - Connect Biopharma is advancing the development of rademikibart, a potential treatment for acute exacerbations in patients with COPD and asthma, with the initiation of the Phase 2 Seabreeze STAT COPD study expected to report topline data in the first half of 2026 [1][2] Company Overview - Connect Biopharma is a clinical-stage biopharmaceutical company focused on transforming care for asthma and COPD, headquartered in San Diego, California [4] - The company is developing rademikibart, a next-generation anti-interleukin-4-receptor alpha (IL-4Rα) antibody, targeting the significant unmet need in acute exacerbations among asthma and COPD patients [4] Study Details - The Seabreeze STAT COPD study is a Phase 2, randomized, double-blind, placebo-controlled trial evaluating rademikibart as an adjunct to standard care for acute exacerbations in COPD patients with type 2 inflammation [3] - Approximately 160 participants will be enrolled globally, characterized by an eosinophil count of ≥300 cells/μL, receiving either rademikibart or placebo [3] - The primary endpoint is the safety and efficacy of rademikibart, measured by the treatment failure rate over 28 days following an acute exacerbation [3] Market Need - There is a major unmet need for fast and effective treatments for acute exacerbations in COPD and asthma, with 1.3 million patients visiting emergency departments annually for COPD flare-ups [3] - Approximately 50% of these patients experience treatment failure within four weeks of an exacerbation, highlighting the necessity for new therapeutic options [3] Clinical Data - Previous Phase 2 data indicated that rademikibart has the potential to improve outcomes for COPD patients, particularly those with elevated eosinophil counts [2] - In prior trials, rademikibart demonstrated strong efficacy and safety, with significant reductions in exacerbations and rapid improvements in forced expiratory volume (FEV1) observed within one week [4]

SAN DIEGO, May 13, 2025 (GLOBE NEWSWIRE) -- Connect Biopharma Holdings Limited (Nasdaq: CNTB) (Connect Biopharma, Connect or the Company), a clinical-stage biopharmaceutical company focused on transforming acute and chronic care of asthma and chronic obstructive pulmonary disease (COPD), today announced the initiation of its Phase 2 Seabreeze STAT Asthma study (NCT06940141) following written agreement on the final study protocol from the U.S. Food and Drug Administration. The study will evaluate the safety ...

– Data to be presented supports development of rademikibart for patients with moderate-to-severe asthma or COPD experiencing an acute exacerbation – Connect Biopharma is a clinical-stage biopharmaceutical company dedicated to transforming care for asthma and COPD. Headquartered in San Diego, California, the company is advancing rademikibart, a next-generation, potentially best-in-class anti-interleukin-4-receptor alpha (IL-4Rα) antibody. With an initial focus on acute exacerbations—an area with significant ...

Core Insights - Connect Biopharma is set to initiate parallel Phase 2 trials for rademikibart in patients with moderate-to-severe asthma or COPD experiencing acute exacerbations, with trials expected to start in Q2 2025 [1][2] Company Overview - Connect Biopharma is a clinical-stage biopharmaceutical company focused on transforming care for asthma and COPD, headquartered in San Diego, California [5] - The company is advancing rademikibart, a next-generation anti-interleukin-4-receptor alpha (IL-4Rα) antibody, targeting acute exacerbations in asthma and COPD [5] Clinical Trials - The two Phase 2 trials will each enroll approximately 160 patients with uncontrolled, moderate-to-severe asthma or COPD, specifically those with eosinophils ≥300 cells/µL [3] - The trials aim to evaluate the effects of a single 600 mg subcutaneous dose of rademikibart over a 28-day period following an acute exacerbation [3] - Previous studies indicated that about 45% of patients receiving standard care experienced treatment failure within 28 days post-exacerbation, highlighting the need for improved treatments [3] Expected Outcomes - Data from the Phase 2 trials is anticipated to be reported in the first half of 2026, with the company having a cash runway into 2027 [3] - Rademikibart has shown promising results in prior studies, demonstrating rapid improvements in pulmonary function within 24 hours [2][5]

Core Insights - Connect Biopharma announced positive results from the global Phase 2 trial of rademikibart, indicating its potential as a novel biologic treatment for asthma and Type 2 inflammation, with significant improvements in lung function and reduced exacerbation rates [1][6]. Group 1: Trial Results - The Phase 2 trial involved 322 adult patients with moderate-to-severe uncontrolled asthma, randomized to receive either rademikibart (150 mg or 300 mg every 2 weeks after a 600 mg loading dose) or placebo for 24 weeks [2]. - Significant improvements in forced expiratory volume in one second (FEV1) were observed, with a mean difference from placebo of +420 mL in patients with eosinophils ≥300 cells/µL at baseline [5]. - Rademikibart demonstrated rapid onset of action, with improvements in FEV1 beginning at week one and sustained through 24 weeks [1][2]. Group 2: Safety and Efficacy - Rademikibart was generally well-tolerated, with most treatment-emergent adverse events being mild or moderate, and no serious adverse events related to the treatment [5]. - No eosinophilia-related adverse events were reported, contrasting favorably with other biologics like dupilumab, which had a 13% incidence in similar patient subgroups [5][6]. - The treatment resulted in fewer acute exacerbations compared to placebo, with 24 events in 214 patients receiving rademikibart versus 26 events in 108 patients receiving placebo [5]. Group 3: Future Prospects - Based on the trial data, Connect Biopharma received FDA agreement to advance rademikibart into Phase 3 trials for asthma maintenance treatment [3]. - The company sees significant opportunities to study rademikibart in the critical period following acute exacerbations of asthma or COPD, where current therapies have not been systematically studied [6]. - Rademikibart has the potential to address the needs of approximately 1 million asthma patients and 1.3 million COPD patients in the U.S. who experience acute exacerbations annually [7].

Product Development and Clinical Trials - Connect Biopharma is advancing rademikibart, a next-generation anti-IL-4Rα antibody, targeting significant unmet needs in asthma and COPD [20]. - In a Phase 2b trial, rademikibart demonstrated a significant improvement in lung function, with a 140 ml (p = 0.005) improvement in FEV for the 150 mg group and 189 ml (p < 0.001) for the 300 mg group at Week 12 [31]. - The trial also showed a 63% average reduction in annual exacerbation rate for COPD patients treated with rademikibart [25]. - Rademikibart has shown a rapid onset of action, with significant improvements observed within 24 hours of administration [25]. - Rademikibart's clinical development program aims to address the unmet needs in acute asthma and COPD, targeting approximately 1 million asthma and 1.3 million COPD patients visiting emergency departments annually [25]. - Rademikibart met both primary and key secondary endpoints, showing significant improvements in skin clearance, disease severity, and itch compared to placebo [40]. - The primary endpoint for the PRC-specific pivotal trial was the percentage of patients achieving IGA 0/1 at Week 16, with key secondary endpoints including EASI-75 [38]. - The company plans to seek accelerated approval for its Product Candidates, which may involve additional clinical trials if initial approvals are not granted [186]. - The company currently has one Product Candidate, rademikibart, in clinical development, with significant investment in its development and preclinical studies [191]. - The company has not yet submitted an NDA or BLA and lacks experience in preparing regulatory filings [199]. - The success of the company's Product Candidates depends on demonstrating safety and efficacy in clinical trials, which may not be achieved [192]. - The company faces risks of regulatory authorities requiring additional studies or denying approval based on clinical trial results [203]. - The FDA and NMPA may withdraw approval if confirmatory trials do not verify clinical benefits [190]. - Clinical trials are time-consuming and expensive, with uncertain outcomes that may delay or prevent product commercialization [162]. - Regulatory approvals are contingent on successful completion of extensive clinical trials, which may face delays or failures [164]. - Clinical trials in foreign countries, such as Ukraine, have been impacted by the Russia-Ukraine war, delaying completion and data collection [165]. - Delays in patient enrollment and potential withdrawal from clinical trials could materially affect the development and approval process of product candidates [170]. - The integrity of clinical trial data may be questioned due to financial relationships with principal investigators, potentially delaying approval processes [167]. - The company is exploring opportunities for its product candidates under fast track designation, breakthrough therapy designation, priority review, and accelerated approval to expedite development and approval processes [83]. Market and Competition - Approximately 23 million adults and 5 million children suffer from asthma in the U.S., with an estimated 262 million affected globally, leading to 455,000 deaths in 2019 [21]. - COPD affects approximately 14.2 million adults in the U.S. and 480 million globally, resulting in an estimated 3.5 million deaths annually [22]. - The company faces intense competition from various sources, including larger pharmaceutical companies with greater resources and established market presence [42]. - The company is focused on T cell modulation activity, which is an unproven approach and may face competition from alternative technologies [194]. Financial Performance and Funding - The company incurred net losses of $15.6 million and $62.1 million for the years ended December 31, 2024 and 2023, respectively, with an accumulated loss of $345.4 million as of December 31, 2024 [146]. - Substantially all losses have resulted from expenses related to research and development programs and general administrative costs [146]. - The company expects to continue incurring significant losses for the foreseeable future as it conducts ongoing and planned preclinical studies and clinical trials [146]. - Substantial additional capital is required to fund product development and commercialization, with existing capital insufficient for regulatory approvals [148]. - Future financing requirements will depend on various factors, including clinical trial costs and regulatory review outcomes [153]. - The company maintains cash and cash equivalents with major financial institutions, with deposits exceeding insured limits, posing potential risks [156]. - The company has an effective shelf registration statement covering the offering of up to $300 million in ADSs, which could lead to substantial dilution for existing shareholders [157]. Regulatory Environment - The company is subject to extensive regulation by the FDA and other authorities, which imposes substantial requirements on drug development and marketing [60]. - The FDA requires an Investigational New Drug (IND) application to be effective before human clinical trials can begin, which automatically becomes effective 30 days after submission unless safety concerns arise [62]. - Clinical trials are divided into three phases, with Phase 1 focusing on safety and dosage, Phase 2 on preliminary efficacy, and Phase 3 on expanded patient populations to establish risk/benefit ratios [71]. - The FDA aims to review standard applications within 10 months and priority reviews within 6 months after filing, with potential extensions for major amendments [74]. - Approval of a New Drug Application (NDA) or Biologics License Application (BLA) may require post-market studies to monitor safety and effectiveness [77]. - The FDA offers expedited development programs, such as the fast track designation, for product candidates addressing serious conditions and unmet medical needs [78]. - The company must ensure compliance with Good Manufacturing Practices (cGMP) before the FDA approves any application [75]. - The FDA may condition approval on the implementation of Risk Evaluation and Mitigation Strategies (REMS) to manage known risks associated with a product [77]. - The company must submit an initial pediatric study plan within 60 days after an end-of-Phase 2 meeting for products with new active ingredients or indications [73]. - The FDA's goal for priority review designation is to take action on marketing applications within six months of the 60-day filing date, compared to ten months under standard review [81]. - Orphan drug designation can be granted for drugs intended to treat rare diseases affecting fewer than 200,000 individuals in the U.S., providing potential benefits such as tax credits and a waiver of application user fees [84][86]. - Products with orphan drug designation that receive FDA approval are entitled to seven years of orphan drug exclusivity, preventing approval of similar products for the same condition [85]. - The FDA may withdraw approval if compliance with regulatory requirements is not maintained, which could lead to product recalls or fines [89]. - The company must comply with extensive FDA regulations post-approval, including record-keeping and reporting of adverse experiences [88]. - The Biologics Price Competition and Innovation Act allows for an abbreviated approval pathway for biosimilars, which can reduce the time and cost for market entry [96]. - The approval process for clinical trials and product marketing varies significantly across foreign jurisdictions, and there is no assurance that FDA approval will lead to similar approvals abroad [99]. - The company is subject to various healthcare regulations, including the federal Anti-Kickback Statute, which prohibits inducements for referrals or purchases related to federal healthcare programs [101]. - The ACA increased the minimum Medicaid rebates for brand name drugs from 15.1% to 23.1% [115]. - The Inflation Reduction Act of 2022 imposes inflation rebates on drug manufacturers if prices increase faster than inflation, starting in 2023 [119]. - The IRA will cap annual out-of-pocket spending for Medicare Part D beneficiaries at $2,000 starting in 2025 [119]. - The U.S. government and state legislatures are implementing cost-containment programs, including price controls and restrictions on coverage [110]. - The EU allows member states to control prices of medicinal products and restrict reimbursement options [111]. - The HTA Regulation adopted in December 2021 aims to provide a transparent framework for health technology assessments in the EU [114]. - The Physician Payments Sunshine Act requires manufacturers to report payments and transfers of value to healthcare providers [106]. - The company is subject to the Foreign Corrupt Practices Act, which prohibits bribery of foreign officials [121]. - Compliance with various state and federal data privacy laws, such as the California Consumer Privacy Act, is required [122]. - The company is not a HIPAA covered entity but could face penalties for unauthorized access to protected health information [123]. Operational Challenges - The company does not own manufacturing facilities and relies on third-party contract manufacturers for production [46]. - The company has limited infrastructure and resources, which may impact the timely initiation and completion of clinical trials [191]. - Reliance on third-party clinical investigators and CROs poses risks; failure to meet contractual obligations could harm regulatory approval and commercialization efforts [213][214]. - The company relies on third-party manufacturers for the production of Product Candidates, which increases the risk of supply disruptions and delays in clinical trials [220][221]. - The company is continuously evaluating multiple vendors to ensure a continuous supply of Product Candidates for global studies and trials, but establishing agreements on acceptable terms remains a challenge [221]. - Disruptions at the FDA and NMPA due to government policies and funding shortages could hinder timely product development and approval, negatively impacting business operations [207]. - The FDA postponed most inspections during the COVID-19 pandemic, which could significantly affect the timely review and processing of regulatory submissions [208]. - Proposed revisions to EU legislation on pharmaceuticals could reduce regulatory data protection, potentially allowing faster access for generics and biosimilars in the EU market [212].

Exhibit 99.1 Connect Biopharma Reports 2024 Full-Year Financial Results and Provides Business Update Strengthened leadership team with key appointments, including Barry Quart, Pharm.D. as CEO, and David Szekeres as President, bringing deep clinical, regulatory, operational and strategic expertise Unveiled rapid clinical development program for rademikibart initially targeting acute care in asthma and COPD; expect to initiate parallel Phase 2 trials in 2Q 2025 with data expected in 2H 2026 Strong balance she ...

Strengthened leadership team with key appointments, including Barry Quart, Pharm.D. as CEO, and David Szekeres as President, bringing deep clinical, regulatory, operational and strategic expertise Unveiled rapid clinical development program for rademikibart initially targeting acute care in asthma and COPD; expect to initiate parallel Phase 2 trials in 2Q 2025 with data expected in 2H 2026 Strong balance sheet with cash runway into 2027 and through key clinical catalysts SAN DIEGO, March 31, 2025 (GLOBE NEW ...

Core Viewpoint - Connect Biopharma Holdings Limited has received a notification from Nasdaq regarding non-compliance with the minimum bid price requirement for its American Depositary Shares (ADSs), which have been trading below $1.00 for the last 30 consecutive business days [1][2]. Compliance and Listing Status - The company has been granted an initial compliance period of 180 calendar days, until September 22, 2025, to regain compliance by having its ADSs close at or above $1.00 for at least ten consecutive business days [2]. - The Nasdaq letter does not have an immediate effect on the trading of the company's ADSs, which will continue to trade under the symbol "CNTB" [2]. - If compliance is not regained by the deadline, the company may be eligible for an additional 180-day compliance period, contingent upon transferring to the Nasdaq Capital Market and meeting other listing requirements [3]. Company Overview and Product Development - Connect Biopharma is focused on developing treatments for asthma and chronic obstructive pulmonary disease (COPD), with its lead product candidate being rademikibart, an anti-interleukin-4-receptor alpha (IL-4Rα) antibody [4]. - Rademikibart has shown promising results in a Phase 2 trial for asthma, demonstrating significant efficacy and safety, including rapid improvements in forced expiratory volume [4].

Company Overview - Connect Biopharma is a clinical-stage biopharmaceutical company based in San Diego, California, focusing on transforming care in Asthma and Chronic Obstructive Pulmonary Disease (COPD) [3] - The company is advancing Rademikibart™, a next-generation anti-interleukin-4-receptor alpha (IL-4Rα) antibody, which aims to address acute indications in asthma and COPD [3] Upcoming Conferences - Company management will participate in the Leerink Partners Global Biopharma Conference on March 12, 2025, at 1:40 p.m. ET [1] - The company will also be present at the H.C. Wainwright 3rd Annual Autoimmune & Inflammatory Disease Virtual Conference on March 27, 2025, at 2:30 p.m. ET [2] - Live webcasts for these events will be available on Connect's website, with archived replays accessible for approximately 90 days post-event [2] Market Opportunity - Rademikibart targets approximately 1 million asthma and 1.3 million COPD patients in the U.S. who experience acute exacerbations annually, representing a significant untapped market [3] - The drug has shown promising efficacy and safety in Phase 2 studies, with a rapid onset of action observed as early as 24 hours [3]