Dexlansoprazole

(all amounts are in Canadian dollars) Quarter ended April 30, 2026, net loss of $1.9 million dollars, ($0.70) per share Nine months ended April 30, 2026, net loss of $5.7 million dollars, ($2.07) per share Cash as of April 30, 2026, $0.7 million Company remains debt-free QUÉBEC, June 29, 2026 /PRNewswire/ - Devonian Health Group Inc. (" Devonian" or the " Company") (TSXV: GSD) (OTCQB: DVHGF), a clinical-stage biopharmaceutical company focused on developing innovative therapies targeting fibro-inflammatory diseases, today highlighted its financial and operating results for the three and nine months ended April 30, 2026. ''We are pleased with the continued momentum to execute on our priorities and readiness to advance our pipeline'', said Dr. André P. Boulet, PhD, Chief Executive Officer and president of Devonian. Corporate Highlights Strategic Update Company expects to remain highly focused on the development of Thykamine™ in prevention of Radiodermatitis associated to radiotherapy and in the treatment of Atopic Dermatitis in children. Furthermore, the Company will continue to investigate the mechanisms of action of Thykamine™ while advancing the evaluation of its potential as a novel therapeutic candidate for Metabolic Dysfunction-Associated Steatohepatitis (MASH) and fibrotic diseases. Financial Highlights Net Loss and Comprehensive Loss For the three months ended April 30, 2026, the net loss and comprehensive loss was $1.9 million, $0.70 per share, compared to a net loss and comprehensive loss of $4.8 million, $1.94 per share, for the same period in 2025. This decrease of $2.9 million in net loss and comprehensive loss is mainly related to the $4.8 million impairment loss of intangible assets and Goodwill related to the generic business (Altius) recorded in the prior fiscal year, following the expiry of the distribution agreement related to Dexlansoprazole which is partly offset by higher losses from operations for an amount of $1.9 million. For the nine-month period ended April 30, 2026, the net loss and comprehensive loss was $5.7 million, $2.07 per share, compared to a net loss and comprehensive loss of $5.6 million, $2.28 per share, for the same period in 2025. This increase of $0.1 million in net loss and comprehensive loss is primarily due to a higher loss from operations of $5.2 million mainly related to $6.5 million decrease in gross margin, related to the prior period sales only of Dexlansoprazole, partly offset by a decrease of $0.6 million in research and development, $0.5 million in selling and administrative and $0.2 million in financial expenses. The increase in net loss and comprehensive loss was also due to a decrease of $0.1 million in interest income and was partly compensated by $4.8 million lower other expenses related to the impairment of intangible assets and Goodwill related to the generic business (Altius) and $0.4 million lower income tax expenses. Liquidity and Cash Flows As of April 30, 2026, the Company had cash and cash equivalents totaling $0.7 million compared to $7 million as of July 31, 2025. For the nine months ended April 30, 2026, the Company used $8.4 million of cash flows for its operating activities (composed of $4.3 million net loss after items not affecting cash and $4.1 million net change in non-cash working capital items), which were partially offset by the cash inflows of $2 million from two private placements completed as well as warrants exercised of $0.2 million during the same period. The Company is debt-free. To consult the Interim Consolidated Financial Statements and the Management's Discussion and Analysis of Financial Condition and Results of Operations for the three and the nine months ended April 30, 2026 and 2025, please click on the following link : or see the Company profile on SEDAR+. About Thykamine™ Thykamine™, the first pharmaceutical product issued from Devonian's SUPREX™ platform, is a highly innovative product for the prevention and treatment of health conditions related to inflammation and oxidative stress including ulcerative colitis, atopic dermatitis, psoriasis, rheumatoid arthritis, and other autoimmune disorders. The anti-inflammatory, anti-oxidative and immunomodulatory properties of Thykamine™ have been demonstrated by a considerable number of in vitro and in vivo studies as well as in a Phase IIa clinical study in patients with mild-to-moderate distal ulcerative colitis and in a large Phase II study in adult patients with mild-to-moderate Atopic Dermatitis. Both Thykamine™ and SUPREX™ platform are covered by patents issued in several North American, European, and Asian countries. About Devonian Devonian Health Group Inc. is a clinical stage pharmaceutical company specializing in the development of drugs for various auto-immune fibroinflammatory disease with novel therapeutic approaches to targeting unmet medical needs. Devonian's core strategy is to develop prescription drugs for the treatment of fibroinflammatory autoimmune diseases including but not limited to atopic dermatitis, radiodermatitis and ulcerative colitis. Devonian is involved in the development of high-value cosmeceutical products leveraging the same proprietary approach employed with their pharmaceutical offerings. Devonian owns a commercialization unit, Altius Healthcare LP, focused on selling prescription pharmaceutical products in Canada, under licenses from brand name pharmaceutical companies. Devonian Health Group Inc. was incorporated in 2015 and is headquartered in Quebec, Canada where it owns a state-of-the-art extraction facility. Devonian is traded publicly on the TSX Venture Exchange (the " Exchange") ( TSXV: GSD) and currently quoted on the OTCQB Venture Market ( OTCQB: DVHGF). For more information, visit . Cautionary Note Regarding Forward-Looking Statements All statements, other than statements of historical fact, contained in this press release including, but not limited to those relating to the Company transitioning toward a focused biopharmaceutical development strategy centered on Thykamine™, its radiodermatitis prevention Prospective Performance clinical study, its Atopic Dermatitis study in Children and pre-clinical studies, potential hepatoprotective effect preventing the progression of liver disease in MASH model, anti-inflammatory and anti-fibrotic effects with the potential to target the underlying pathology of the disease and thus halt the progression of the disease; and generally, the above "About Devonian" paragraph, all of which essentially describes the Company's outlook, constitute "forward-looking information" or "forward-looking statements" within the meaning of certain securities laws (collectively, "forward-looking statements"), and are based on expectations, estimates and projections as of the time of this press release. Such forward-looking statements may be identified by the use of words such as "intends", "believes", "expects", or variations (including negative and grammatical variations) of such words and phrases, or state that certain actions, events or results "may", "could", "would", or "will" be taken, occur or be achieved. Forward-looking statements are necessarily based upon a number of estimates and assumptions that, while considered reasonable by the Company as of the time of such statements, are inherently subject to significant business, economic and competitive uncertainties and contingencies. These estimates and assumptions may prove to be incorrect. Many of these uncertainties and contingencies can directly or indirectly affect, and could cause, actual results to differ materially from those expressed or implied in any forward-looking statements. There can be no assurance that these assumptions will prove to be correct and there can be no assurance that forward-looking statements will prove to be accurate, as actual results and future events could differ materially from those anticipated in such statements. By their very nature, forward-looking statements involve inherent risks and uncertainties, both general and specific, and risks exist that estimates, forecasts, projections and other forward-looking statements will not be achieved or that assumptions do not reflect future experience. Forward-looking statements are provided for the purpose of providing information about management's expectations and plans relating to the future. Readers are cautioned not to place undue reliance on these forward-looking statements as a number of important risk factors and future events could cause the actual outcomes to differ materially from the beliefs, plans, objectives, expectations, anticipations, estimates, assumptions and intentions expressed in such forward-looking statements. All of the forward-looking statements made in this press release are qualified by these cautionary statements and those made in our other filings with the applicable securities regulators of Canada. The Company disclaims any intention or obligation to update or revise any forward-looking statements or to explain any material difference between subsequent actual events and such forward-looking statements, except to the extent required by applicable law. Neither the Exchange nor its Regulation Services Provider (as that term is defined in policies of the Exchange) accepts responsibility for the adequacy or accuracy of this release. 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非临床药效学研究考察药物与其靶点之间的相互作用以及由此而产生的药理学效应。通过药效学研究，可以预测新化合物对临床拟用适应症的有效性，阐明药物的作用特点，为设计优化临床试验方案，揭示药物的毒性机制并制定风险控制计划提供理论依据，进一步预测药物的临床价值及开发前景。 据统计，药物有效性是Ⅱ、Ⅲ期临床失败的最主要原因。国临床试验期间药物警戒与国际先进药物警戒体系接轨，提出相关工作建议。 1 药效学研究 药效学研究内容包括验证药物在不同系统/模型中的有效性，表征药物作用的量效、时效关系，探索药物的给药方案以及阐明药物的作用机制。 药效学研究是新药开发过程中的重要内容，贯穿于新药开发的整个过程。 在非临床开发阶段，主要药效学研究结果为药物进入临床提供有效性支持，对预测首次临床试验起始剂量及优化临床试验方案至关重要，并为毒理学研究相关动物选择、剂量设计及检测指标设置提供依据; 次要药效学研究有利于了解药物的作用特点，预测非预期的人体不良效应，为临床制定风险管控计划提供参考。 临床开发阶段对药理学放大引起不良反应及非预期不良反应的作用机制进一步研究，为了解药物的作用特点和毒性机制，指导临床用药提供参考。 药物上市后进一步的药效学研究可为新适应症或联合用药开发、药物工艺变更及药物的迭代开发提供数据支持。 药效学研究涉及体外和体内试验。 体外试验是在分子、细胞、离体组织或器官等水平上的研究，可初步了解药物的作用和机制，一般在新药的早期研发阶段开展。 体内试验是在生物整体水平上的研究，是支持临床拟用适应症有效性的重要依据。 但是对于某些适应症无疾病相关的体内模型可供选择时，体外研究数据也可作为有效性的依据。 2 药效学评价关注点 药效学评价中应关注受试物、试验设计、试验方法、对照药选择，观察指标应与临床相关性好，有效性指标判断明确、准确。 2. 1 受试物 通常受试物应与拟进行临床研究所用的药物一致或者能代表临床研究样品。 但新药的药学研究是不断完善的过程，为了提高产品质量，开发过程中可能需要对工艺、处方等不断改善。 若非临床研究样品与临床样品有大的差异，建议进行必要的桥接研究，以判断药学改变对受试物安全有效性的影响。 如某药物用原料进行了非临床安全有效性研究，因生物利用度低，开发过程中对原料进行微粉化处理，对此，开展了微粉化与非微粉化样品的药代、毒理的对比桥接研究，比较二者在体内的暴露量的变化，为临床I 期剂量的选择提供支持。 2.2 动物模型 在疾病相关动物模型中开展的药效学试验是支持临床拟用适应症和给药方案的重要依据。 动物模型选择主要考虑与临床的相关性，应能反应临床疾病病理和生理过程，包括对受试物敏感程度、发病机制、损伤程度等与临床的相似性。 药效学研究一般选用经典、公认的动物模型。 由于种属差异、病理生理机制及进程不同，单一动物模型用于预测人体有效性往往具有局限性，用多种模型进行药效学研究可从多个方面提示有效性，提高药物研发成功率。 比如胰高血糖素样肽-1( GLP-1) 受体激动剂类降糖药艾塞那肽，体内试验采用了非糖尿病动物(小鼠、大鼠、兔) 和糖尿病动物( db /db 小鼠、ob /ob 小鼠、糖尿病ZDF 大鼠和肥胖葡萄糖不耐受fa /fa 大鼠、糖尿病猕猴) 开展有效性评价。 由于种属差异，临床中有些疾病或症状不能在动物模型上复制或相关性不高，比如专嗜人细胞的传染病病原［如人类免疫缺陷病毒( HIV) 、丙型肝炎病毒( HCV) 等］疾病、癌症、自身免疫性疾病等，可考虑采用转基因动物或人源化动物模型。 某些生物制品，其生物活性通常具有种属和/或组织特异性，药理学研究应选用相关动物种属或建立转基因动物，或采用替代分子或同源蛋白进行相关有效性评价。 地舒单抗( Denosumab，商品名: Prolia®) 系重组人源化靶向核因子-κB 受体活化因子配体( RANKL) 抗体，用于骨质疏松症的治疗，Denosumab 在啮齿类动物中无药理活性，体内试验采用了人RANKL 基因敲入小鼠模型、过表达骨保护素( OPG) 大鼠转基因模型及OPG 与抗体Fc 段构建的替代融合蛋白( OPG-Fc) 评价药物的活性。 纳武利尤单抗( Nivolumab，商品名: OPDIVO/欧狄沃) 系重组人源化程序性死亡受体1( PD－1) 抗体，用于多种肿瘤治疗，其不与小鼠PD-1 结合，为评价药物对小鼠移植瘤生长的抑制作用，构建了替代嵌合抗小鼠PD-1 抗体4H2。 2.3 试验设计 结合新药作用靶点、适应症特点选择试验方法。 试验方法一般为国内外公认的方法，新方法、新模型应进行充分的验证。 参照随机、对照、重复、“3R”原则进行科学、合理的试验设计，以排除非处理因素对试验结果的干扰，获得可靠的试验数据，为毒理学研究及临床试验方案设计提供参考。 药效学研究一般给药途径与临床拟给药方式一致，根据药物及疾病的特点设计给药时间，为临床方案的设计提供参考。 如某降低尿酸药物临床拟用于治疗高尿酸症，非临床药效学研究中于造模同时给药，所得结果对支持临床治疗给药的有效性提示有限。剂量设计应能反应药物的量效关系。 体外试验应能反应药物的浓度效应关系［如半数抑制浓度( IC50) 、半数有效剂量( ED50) 等］和有效剂量范围［如最低抑菌溶度( MIC) 等］。 体内试验应研究药物的有效剂量范围和量效/时效关系，最低起效剂量对于计算临床起始剂量及预测药物的安全范围有重要价值。新药的研究一般应设立对照组，根据试验方案的具体要求设立阴性对照( 空白对照) 、溶剂对照、模型对照、阳性对照。 对照组可验证试验系统的可靠性，排除非药物因素的干扰。 如采用转染hERG的HEK293 或CHO 细胞评价药物对hERG 钾电流的抑制作用，需设阳性药对照，排除因基因突变出现的假阴性结果。 观察指标应与临床有较好的相关性，反应药物作用特点。 如作用于免疫系统的抗风湿药物，体内药效学试验需检测与药效相关的因子、免疫指标、关节的变化、病理等指标。 2.4 试验数据 应提供详细、具体的试验数据，对试验获得数据进行总结和分析，对未纳入分析的数据进行说明，对具有统计学差异的数据，结合药物的量效关系、历史背景数据及基础数据等，评价其生物学意义及与临床的相关性。 对资料进行规范化整理，以更好的呈现数据，便于审评与研发人员之间的信息交流。 目前国内外均非常重视申报资料的规范化，人用药注册技术要求国际协调会议( ICH) 颁布ICH M4 系列文件用于规范人用药品注册通用技术资料( CTD) 的申报格式，中国要求自2018 年2 月1 日起化药、生物制品新药注册申请( NDA) 适用ICH M4。 2.5 不同类别新药的考虑 不同类别新药药效学研究不同。 对于创新药，非临床药效学研究应尽量选择多个与临床疾病相关的体内外模型，阐明药物的作用特点及对临床拟用适应症的有效性，并进行相应的概念验证。 托法替布( Tofacitinib;商品名Xeljanz®/尚杰®) 系Janus 激酶( JAK) 抑制剂，2012 年在美国上市用于风湿性关节炎( RA) ，体外试验研究显示托法替布是JAK1 /2 /3 选择性抑制剂，可降低对细胞因子信号传导( IL-2、-4、-6、-10、-15 和-21) 的应答，从而减少其他细胞因子和炎症介质的合成和分泌。 体内研究结果显示:托法替布可降低胶原诱导小鼠RA 模型和佐剂诱导大鼠RA 模型爪关节炎评分( 肿胀、水肿和爪体积) ，次要药效学研究评价了托法替布对一系列受体、离子通道和酶的作用，其中对血管内皮生长因子受体1 的作用可能与非临床毒理学研究中出现的出血等发现相关。 在已知活性成份的基础上，对其结构、剂型、处方工艺、给药途径等进行优化，如改善稳定性，增加药效、降低副作用、延长作用时间减少用药次数等的改良型新药，是药物研究的一个方向。 该类药物有一定的研究基础，作用机制明确，开发中主要关注是否具有“明显临床优势和/或临床特点”，一般根据改良目的开展与被改的药物对比的非临床研究，支持其进行临床研究。 如质子泵抑制剂兰索拉唑消旋体拆分为右旋兰索拉唑，体内研究数据显示右旋体抑制胃酸分泌的作用强于消旋体，药效学研究支持开发右旋兰索拉唑药效强于消旋兰索拉唑的目的。 2.6 机制研究 药物的治疗作用源自对作用机制的理解，了解同类药物的药理学特征有助于指导候选药物的开发。 Omadacycline( 商品名Nuzyra)系一种氨甲基环素类广谱抗生素，体外机制研究结果提示Omadacycline 通过与细菌核糖体的30S 亚基结合终止蛋白质合成，从而发挥抑菌活性; 对存在核糖体保护蛋白和/或外排泵突变产生四环素耐药的菌株仍具有活性，提示Omadacycline规避了常见的四环素耐药机制，为临床解决四环素耐药问题提供了新的用药选择，临床开发口服或静脉注射用于成人社区获得性细菌性肺炎( CABP ) 和急性细菌性皮肤和皮肤结构感染( ABSSSI) 。 非临床评价阶段应初步阐明药物发挥药效作用的本质。 由于机体和药物作用的复杂性及新药研究的不确定性，药物作用机制的研究贯穿于药物研发的整个研究阶段。 随着对药物作用特点的不断了解，进行药物新适应症及复方制剂的开发，成为新药研究的一个方向。 该类药物开展临床试验前，需提供支持复方制剂或新适应症的试验数据和/或文献依据。 替米沙坦是特异性非肽类血管紧张素Ⅱ受体阻断剂，氢氯噻嗪为噻嗪类利尿剂，两个药物通过不同的作用机制发挥降压作用，自发高血压大鼠研究显示两种降压药物联合给药后可起到相加的降压作用，为复方制剂替米沙坦氢氯噻氢片( 商品名Micardis® HCT) 的开发提供了有效性支持。 3 药效学研究中的不足 3.1 研究不充分 非临床药效学研究包括机制阐明不清、体内研究数据不能充分提示其有效性。 如某二酰基甘油酰基转移酶( DGAT1) 抑制剂拟通过抑制甘油三酯( TG) 合成和吸收，调节机体脂质代谢，增加胰岛素敏感性用于肥胖型2 型糖尿病，药效学研究采用正常ICR 小鼠、KK-Ay 小鼠、高脂饮食诱导肥胖DIO 小鼠及ob /ob 小鼠评价了药物的降糖降脂作用，结果在动物模型中血清TG 未见降低，大鼠重复给药毒性试验中可见TG 升高，与预期作用机制不能相互佐证; 且糖尿病动物模型研究中未见一致的降糖作用，故药效学数据不能提示该药具有降糖的作用。 此外，还有采用动物模型单一、指标设置少，如降糖药仅采用1 种糖尿病动物模型，抗风湿性关节炎药物未评价关节病理或对炎症因子的影响等。 3.2 受试物不能代表临床样品 药效学研究中采用的受试物不能代表临床拟用样品。 如某一细胞产品新药临床试验( IND) 申请，提供为多年前科研性药效研究，期间所采用的细胞提取、培养、扩增工艺均发生变化，未进行变更前后样品可比性分析，故提供的数据不能提示临床拟用样品的有效性。 3.3 试验资料整理不规范完整 提供的试验数据简单，受试物信息不明确，不提供具体试验方案、试验结果数据等，基于提供的信息不能评价其有效性。 如某一新药IND 申请，申报资料中非临床研究仅罗列了发表的科研性文章，不清楚文献中的受试物与临床拟用受试物的相关性，无具体的试验方案及试验结果，所提供的资料不能评价药物的有效性。 4 讨论 非临床药效学研究对药物开发至关重要，药物有效性问题是Ⅱ、Ⅲ期临床失败的最主要原因。研发者应结合药物本身及拟用适应症特点，开展非临床药效学研究，研究过程中关注研究的科学性和合理性，确保结果的准确、可靠，并对获得信息进行客观评价和规范整理，以提高药物研发成功率。 文章作者 | 尹华静，戴学栋，尹茅山，吴爽，王寅，李峥，胡晓敏（国家药品监督管理局药品评审中心，北京） 文章来源 | 中国临床药理学杂志 参考文献 | 略（见原文） 中关村（朝阳）数字医疗产业园为北京市首个数字医疗特色产业园，围绕基础研究、科研转化、临床验证、注册上市和应用场景等全周期，构建“技术、人才、资金、市场”等全要素全价值链服务体系，建设国际领先的数字医疗产业创新高地。 招商电话：13601102717 （吕女士） 运营合作：13543250693 （张先生） 园区地址：中关村（朝阳）数字医疗产业园