BT Bidco, Inc.

Healthy volunteer study will evaluate ingestible delivery capsule for oral, needle-free administration of adalimumab with topline data expected by early 2027 SAN DIEGO, Sept. 10, 2026 (GLOBE NEWSWIRE) -- Biora Therapeutics, a biotech company developing BioJet™, a novel, ingestible capsule that uses liquid jet technology to deliver drug into the small intestine for systemic uptake, today announced plans to initiate a first-in-human clinical trial by the end of 2026 evaluating the BioJet capsule for the oral administration of adalimumab. The planned first-in-human trial is expected to assess safety, tolerability, and pharmacokinetics following administration of adalimumab using the BioJet capsule compared to typical subcutaneous injection in healthy volunteers. The data could support a 2027 regulatory filing for clinical development toward registration. “Advancing BioJet into a first-in-human study marks a significant milestone for Biora and the future of biologic drug delivery, as we work toward an oral, needle-free option for the millions of patients who receive frequent injections,” said Adi Mohanty, Chief Executive Officer of Biora Therapeutics. “We have made tremendous progress this year scaling our processes and working toward GMP manufacturing. The BioJet program has demonstrated consistent performance across numerous preclinical studies in multiple species, delivering adalimumab at human therapeutic levels, and we look forward to seeing our first human data early next year.” Biora has an extensive preclinical safety database with over 800 BioJet capsules dosed in multiple large-animal models, including swine, canines, and non-human primates. The BioJet device has been used for oral delivery of a broad range of large-molecule therapeutics, including monoclonal antibodies, peptides, and oligonucleotides. Adalimumab is among the most widely used biologic therapies and is currently administered by injection. By applying BioJet delivery to adalimumab, Biora aims to demonstrate the platform’s potential to deliver existing biologic formulations orally without needles or complex reformulation. The company believes the BioJet platform could support broader use of biologic therapies by reducing the patient burden associated with injections. About Biora Therapeutics BT Bidco, Inc., dba Biora Therapeutics, is a privately held biotech company developing the BioJet™ capsule, a needle-free delivery platform designed to enable oral dosing of proteins, antibodies, and other biomolecules. The BioJet device is an ingestible, single-use device the size of a 00 capsule. It uses Biora’s patented liquid jet technology to deliver biomolecules into the small intestine, aiming to achieve high rates of bioavailability orally and to provide a needle-free alternative for drug delivery. Oral dosing of biomolecules remains a key unmet need for many therapies. If successful, the BioJet™ device could help convert injectable therapies into oral dosage forms, increasing patient convenience, and offering product differentiation for both pipeline candidates and established brands. By accommodating existing liquid drug formulations, the BioJet capsule offers an alternative delivery option for a broad range of biomolecules, including proteins, peptides, and nucleic acids. The BioJet device is investigational and not approved for commercial use. Biora’s comprehensive patent portfolio includes over twenty (20) granted patents with long-dated protection and numerous pending applications, with coverage in all major pharmaceutical markets including the United States, Europe, Japan, and China. Biora™ and BioJet™ are trademarks of Biora Therapeutics. For more information, visit bioratherapeutics.com or follow the company on LinkedIn . Media Contact media@bioratherapeutics.com

Company reports >25% oral bioavailability in swine and non-human primates Progressing multiple collaborations toward partnerships SAN DIEGO, April 08, 2026 (GLOBE NEWSWIRE) -- Biora Therapeutics, a biotech company developing the first swallowable autoinjector, today announced significant progress with its BioJet ™ platform, a needle-free delivery platform designed to enable oral dosing of proteins, antibodies, and other biomolecules. “Since emerging from restructuring as a privately held company with a clean balance sheet, we have been focused on advancing the BioJet platform,” said Adi Mohanty, CEO of Biora Therapeutics. “We are excited about the rapid progress of our smaller ‘00’ sized BioJet device, with its unprecedented payload capacity. We expect to continue to improve performance even further as we advance our BioJet device to IND-readiness, and we are progressing well with multiple collaborations that could bring needle-free oral delivery to patients.” “We are now using the BioJet platform in several large animal models, including swine, canine, and non-human primates, and we’re exceeding most collaborator expectations with 25% or greater mean bioavailability versus IV for oral delivery of both peptides and antibodies, with levels ranging up to 50% for antibodies,” continued Mr. Mohanty. “For comparison, subcutaneous injections of antibodies achieve about 50% bioavailability and other oral technologies like permeation enhancers for peptides reach just 1–5% bioavailability compared to the benchmark of IV administration. We also have a growing safety database with more than 600 devices dosed in large animal studies, and no safety-related issues have been identified in the current preclinical program.” “Looking ahead, we and our pharma collaborators see significant opportunities for pipeline molecules that currently achieve insufficient bioavailability using other delivery technologies to become viable products using BioJet delivery. We also see the obvious potential for established biomolecule brands to greatly improve patient convenience, increasing competitive advantage. In addition, we are exploring opportunities to support internal programs with shorter regulatory approval pathways such as biosimilars,” said Mr. Mohanty. About Biora Therapeutics BT Bidco, Inc., dba Biora Therapeutics, is a privately held biotech company developing the BioJet ™ platform, a needle-free delivery platform designed to enable oral dosing of proteins, antibodies, and other biomolecules. The BioJet device is a swallowable, single-use autoinjector the size of a 00 capsule. It uses Biora’s patented liquid jet technology to deliver biomolecules into the small intestine, aiming to achieve high rates of oral bioavailability without needles. Oral dosing of biomolecules remains a key unmet need for many therapies. If successful, the BioJet ™ platform could help convert injectable therapies into oral dosage forms, increasing patient convenience, and offering product differentiation for both pipeline candidates and established brands. The BioJet platform’s ability to use existing liquid drug formulations and to deliver >300 microliter payloads creates a desirable delivery option for most biomolecules, including proteins, peptides, and nucleic acids. Biora’s comprehensive patent portfolio includes over twenty (20) granted patents with long-dated protection and numerous pending applications, with coverage in all major pharmaceutical markets including the United States, Europe, Japan, and China. Biora ™ and BioJet ™ are trademarks of Biora Therapeutics. For more information, visit bioratherapeutics.com or follow the company on LinkedIn . Media Contact media@bioratherapeutics.com

口服环肽药物正颠覆百年制药规则——分子量突破传统限制，甚至疗效媲美注射剂，患者依从性将迎来质的飞跃。默沙东口服PCSK9环肽抑制剂Ⅲ期临床降低血脂超60%，强生口服IL-23小肽拮抗剂冲击50亿美元市场，而博瑞医药的双靶点GLP-1/GIP口服药已获批临床，全球竞速开启。 研报原文和根据研报整理的音频播客，放在文末。 下面是针对口服环肽/多肽药物的多份研报解读：【研发人员重点关注】 • 从“序列发现”向“架构工程”跨越：2026年被定义为“改性多肽”之年，研发重点已从寻找新序列转向通过分子工程提升药物稳定性。例如，MBX Biosciences的PEP™平台利用糖基共轭技术，能将多肽半衰期从几分钟延长至数周，使天然序列在长期控制研究中趋于过时。 • 口服递送技术的路径分化：目前存在两种主流竞争方案：一是如诺和诺德Rybelus使用的渗透促进剂（SNAC）；二是Protagonist Therapeutics开发的富含二硫键多肽（DRPs），这种“笼状”结构通过分子本身的刚性抵御胃酶降解，无需额外添加促进剂。 • 小分子模拟肽的替代趋势：Crinetics Pharmaceuticals等公司正开发能模拟多肽结合位点的非肽类小分子药物（如口服SSRA药Paltusotine），这为研发人员提供了新的思路：通过彻底改变分子的化学性质来规避多肽的降解问题。 • 单克隆抗体（mAb）的口服突破：由于抗体分子量巨大（约150 kDa），传统吸收极难（生物利用度仅约0.02%）。Biora Therapeutics的BioJet™智能胶囊通过“液体喷射”技术将药物直接注入小肠壁，在猪模型中实现了高达80%的系统生物利用度，且无需重新进行药物剂型改造。 • 靶向α疗法（TAT）的载体选择：在放射性药物研发中，双环肽（Bicyclic Peptides）因渗透快、肾脏清除快，正取代循环时间过长的抗体，成为承载Lead-212等同位素精准打击肿瘤的理想载体。 • 儿童用药制剂的特殊要求：针对无法吞咽大型胶囊的儿童群体，研发方向正转向口服崩解片（ODTs）、多颗粒撒剂或咀嚼片，且优先使用**食品级蛋白质（如酪蛋白）**作为纳米载体，因其具有天然的生物相容性和安全性。 • 临床试验设计新指标：以Icotrokinra（JNJ-2113）为例，其Phase 3 ICONIC-TOTAL研究通过使用部位特异性评分（如ss-IGA针对头皮、sPGA-G针对生殖器），证明了口服多肽在治疗难治区域银屑病方面的独特优势 【投资者决策参考】 • 口服生物药的“营收超级周期”：全球口服蛋白质与多肽市场预计将从2024年的80.5亿美元增长至2034年的363.5亿美元，年复合增长率（CAGR）高达16.34%。这一趋势标志着此类药物正从昂贵的“特种药”向“大众市场”模式转型。 • 代谢与肥胖赛道的统治力：代谢性疾病细分市场在2024年占据了46%的市场份额。随着GLP-1药物适应症扩展至睡眠呼吸暂停、心衰和肾脏疾病，其总潜在市场（TAM）大幅扩张，预计到本十年末销售额将接近2000亿美元。 • 并购（M&A）的主要驱动力：大型药企面对2028-2029年的“专利悬崖”，正利用充沛现金流收购口服递送平台。2025年已出现多起重磅交易，如默克（Merck）以4.93亿美元签署口服技术授权协议，阿斯利康投资500亿美元用于包括多肽在内的研发生产。 • 竞争格局的“二元化”：诺和诺德与礼来通过供应链扩张和口服专利建立了强大的“护城河”。投资者应警惕由于美国FDA宣布Semaglutide短缺解决而对“影子市场”（如仿制配方药房）造成的致命打击，建议转向投资拥有专利技术的龙头企业。 • 产业链底层的“卖水人”：由于口服药物所需的原料药（API）体积远超注射剂，产能成为核心瓶颈。CDMO巨头如Bachem和CordenPharma通过锁定长期生产合同，正从这场多肽战争中稳健获利，不受具体哪款药物胜出的影响。 • 政策与定价风险：随着Medicare对减肥药支出飙升，*价格谈判（IRA）*和政治压力是2025年后影响行业利润率的最大单一风险。 【高校科研方向参考】 • 基础研究突破：FcRn介导的转运机制：高校研究者正探索如何通过重组技术重新设计抗体，使其在更宽的pH范围内与**新生儿Fc受体（FcRn）**结合，利用人体肠道天然存在的跨细胞转运途径实现单抗的全身吸收。 • 新靶点发现与结构生物学：针对“难成药”靶点（如细胞因子、GPCRs、离子通道），利用mRNA展示、DNA编码库（DEL）以及计算匹配技术（如Vectrix™）从头筛选构象受限的多肽支架，是当前学术界转化的热点。 • 多学科交叉：智能机器人胶囊：结合机械工程、生物传感器与材料科学，研发具有自动定位功能（仿生豹纹陆龟形状实现自动翻正）和由pH触发的机械式微注射器，这是解决生物大分子吸收障碍的跨界方案。 • 肠道滞留技术的合作机遇：诺和诺德与BioMed X的合作项目专注于“延长多肽在下小肠的部位特异性滞留”，旨在通过新型配方延长吸收窗口，这为高分子材料和消化系统生理学研究者提供了产学研合作空间。 • 生物标记物的临床意义转化：研究显示hsCRP（超敏C反应蛋白）作为炎症和心血管风险的核心指标，在新型NLRP3抑制剂（如BGE-102）的 Phase 1 试验中降幅达86%，这证明了针对特定生物标记物的转化研究具有高度的商业前景。 • 药动学建模的需求：目前学术界迫切需要建立可靠的体外-体内相关性（IVIVC）模型，以准确预测不同饮食状态（进食与空腹）对口服蛋白质吸收的影响，这是从实验室原型走向商业规模生产的关键缺失环节。 • 放射性核素的精准递送：在肿瘤学研究中，研究重点正转向“螯合剂就绪肽”（Chelator-Ready Peptides），即预先结合了DOTA或NOTA等“金属笼”的多肽，以便快速装载放射性同位素进行分子影像或治疗研究。 根据研报整理的音频播客： 部分参考资料： 2025-11-22-华创证券-华创医药投资观点_研究专题周周谈第151期_多款口服环肽药物具重磅潜力_产业链有望充分受益 20240318-华创证券-创新药周报_强生口服IL-23R多肽拮抗剂治疗银屑病长期疗效积极 20250716-东吴证券-博瑞医药-688166.SH-在研管线进展点评_BGM0504片IND申请获受理_稀缺双靶点口服多肽即将进入临床