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LAVAL, Quebec--(BUSINESS WIRE)-- Crescita Therapeutics Inc. (TSX: CTX and OTC US: CRRTF) (“Crescita” or the “Company”), a growth-oriented, innovation-driven Canadian commercial dermatology company, today reported its financial results for the first quarter ended March 31, 2024 (“Q1-2024”). All amounts presented are in thousands of Canadian dollars (“CAD”) unless otherwise noted, and in accordance with International Financial Reporting Standards (“IFRS”) as issued by the International Accounting Standards Board. Financial Highlights Q1-2024 vs. Q1-2023 Revenue was $4,996 compared to $4,602, up $394; Gross profit was $2,411 compared to $2,736, down $325; Operating expenses were $3,142 compared to $2,972, up $170; Adjusted EBITDA1 was $(325) compared to $161, down $486; Ending cash was $9,531, up $146 for the quarter. Commenting on the Company's results for the first quarter of 2024, Crescita's President and Chief Executive Officer, Serge Verreault, said: “Our Skincare segment continues to represent a strong commercial focus and reflects the impacts of the ART FILLER launch and growth in online sales. During the quarter, we fulfilled a previously deferred purchase order in our Manufacturing segment, which mainly drove the quarter’s incremental volumes and the 8.6% improvement in our topline sales year-over-year. “We continue to advance discussions for a new commercial partnership for Pliaglis in the U.S. and to support our international Pliaglis licensees in recent and upcoming launches, including Poland and the Middle East. With a solid balance sheet, we are poised to take advantage of growth opportunities and return Crescita to profitability.” Operational and Corporate Developments Update on Licensing Agreement for Pliaglis® in China In April 2024, the National Medical Products Administration (the “NMPA”, formerly the China Food and Drug Administration or “CFDA”) confirmed the need for a local clinical trial to support the registration of Pliaglis in China. Our licensing partner, Juyou Bio-Technology Co. Ltd. (“Juyou”) has initiated plans to finalize the protocol for the clinical trial and to manufacture the required test articles. Juyou is presently assessing the timeline for the clinical trial, subsequent registration stages, and the projected launch date. Under the commercialization and development license agreement entered into in November 2020, Juyou is responsible for and shall bear all expenses related to obtaining regulatory approval in China and conducting the required clinical trials. Crescita will supply Pliaglis at a pre-determined transfer price including a profit margin and is eligible for potential regulatory and sales milestones that could exceed US$2.2 million, as well as for tiered double-digit royalties should the product’s retail price surpass specified threshold amounts. Repurchases under our Normal Course Issuer Bid (“NCIB”) In Q1-2024, we repurchased 166,508 common shares through our NCIB at a weighted average purchase price per share of $0.47 for total cash consideration of $78. Q1-2024 Summary Financial Results Note: Select financial information is outlined below and should be read in conjunction with Crescita's Condensed Consolidated Interim Financial Statements and related Management's Discussion and Analysis (“MD&A”) for the three months ended March 31, 2024, which are available on Crescita’s pro SEDAR+ at and on Crescita’s website at . In thousands of CAD, except per share data and number of shares Three months ended March 31, 2024 2023 Change $ $ $ Commercial Skincare 2,535 2,492 43 Licensing and Royalties - 21 (21) Manufacturing and Services 2,461 2,089 372 Revenues 4,996 4,602 394 Cost of goods sold 2,585 1,866 719 Gross profit 2,411 2,736 (325) Gross margin (%) 48.3% 59.5% -11.2% Research and development (“R&D”) 170 160 10 Selling, general and administrative (“SG&A”) 2,587 2,437 150 Depreciation and amortization 385 375 10 Total operating expenses 3,142 2,972 170 Operating loss (731) (236) (495) Interest income, net (116) (98) (18) Foreign exchange (gain) loss 2 (36) 38 Share of (profit) loss of an associate 9 (8) 17 Net loss on convertible note measured at fair value through profit or loss - 13 (13) Loss before income taxes (626) (107) (519) Deferred income tax expense - 166 (166) Net loss (626) (273) (353) Adjusted EBITDA1 (325) 161 (486) Loss per share Basic and diluted $ (0.03) $ (0.01) $ (0.02) Weighted average number of common shares outstanding Basic and diluted 19,591,906 20,334,153 (742,247) Selected Balance Sheet Information Cash and cash equivalents, end of period 9,531 10,275 (744) Selected Cash Flow Information Cash provided by operating activities 378 2,131 (1,753) Cash provided by (used in) investing activities - - - Cash used in financing activities (236) (99) (137) Revenue We have three reportable segments: 1) Commercial Skincare (“Skincare”), which manufactures our branded non-prescription skincare products for sale in Canada and certain international markets, and also commercializes Pliaglis®, NCTF® Boost 135 HA, ART FILLER® and Obagi® Medical in Canada; 2) Licensing and Royalties (“Licensing”), which currently derives revenue from licensing our intellectual property related to Pliaglis; and 3) Manufacturing and Services (“Manufacturing”), which generates revenue from contract manufacturing and product development services. For the three months ended March 31, 2024, total revenue was $4,996 compared to $4,602 for the three months ended March 31, 2023. The year-over-year increase of $394 was primarily driven by incremental revenue in our Manufacturing segment in the amount of $372, mainly due to the fulfillment of a previously deferred purchase order initially scheduled for delivery in the second half of 2023 and reflects pricing concessions on volume. Skincare sales remained essentially flat year-over-year, posting a slight increase of $43, while Licensing segment revenue was $nil for the quarter. Gross Profit and Gross Margin For the three months ended March 31, 2024, gross profit was $2,411, representing a gross margin of 48.3%, compared to $2,736 and 59.5%, respectively, for the three months ended March 31, 2023. The net decreases in gross profit and gross margin of $325 and 11.2%, respectively, were primarily a result of pricing concessions in our Manufacturing segment relating to a purchase order deferred from 2023 into Q1-2024. Operating Expenses For the three months ended March 31, 2024, total operating expenses were $3,142 compared to $2,972 for the three months ended March 31, 2023, representing a net increase of $170. The increase was mainly driven by higher SG&A expenses of $150, primarily due to higher headcount-related expenses and commercial partnership fees to support our digital strategy, partly offset by lower advertising and promotion spend. Cash and Cash Equivalents Cash and cash equivalents were $9,531 at March 31 2024, reflecting a net increase of $146 for the quarter mainly due to a favorable net change in non-cash working capital. Non-IFRS Financial Measures We report our financial results in accordance with IFRS. However, we use certain non-IFRS financial measures to assess our Company’s performance. We believe these to be useful to management, investors, and other financial stakeholders in assessing Crescita’s performance. The non-IFRS measures used in this press release do not have any standardized meaning prescribed by IFRS and are therefore not comparable to similar measures presented by other issuers. These measures should be considered as supplemental in nature and not as a substitute for the related financial information prepared in accordance with IFRS. The following are the Company’s non-IFRS measures along with their respective definitions: EBITDA is defined as earnings before interest, income taxes, depreciation of property, plant and equipment, and amortization of right-of-use asset and intangible assets. Adjusted EBITDA is defined as earnings before interest, income taxes, depreciation of property, plant and equipment and amortization of right-of-use asset and intangible assets, foreign exchange (gains) losses, share of (profit) loss of associates, fair value (gains) losses, share-based compensation costs, restructuring costs, and goodwill and intangible asset impairment, as applicable. Management believes that Adjusted EBITDA is an important measure of operating performance and cash flow and provides useful information to investors as it highlights trends in the underlying business that may not otherwise be apparent when relying solely on IFRS measures. Below is a reconciliation of EBITDA and Adjusted EBITDA to their closest IFRS measures. In thousands of CAD dollars Three months ended March 31, 2024 2023 Change $ $ $ Net loss (626) (273) (353) Adjust for: Depreciation and amortization 385 375 10 Interest income, net (116) (98) (18) Deferred income tax expense - 166 (166) EBITDA (357) 170 (527) Adjust for: Share-based compensation 21 22 (1) Foreign exchange (gain) loss 2 (36) (38) Share of (profit) loss of an associate 9 (8) 17 Net loss on convertible note measured at fair value through profit or loss - 13 (13) Adjusted EBITDA (325) 161 (486) Caution Concerning Limitations of Summary Financial Results Press Release This summary earnings press release contains limited information meant to assist the reader in assessing Crescita’s performance, but it is not a suitable source of information for readers who are unfamiliar with Crescita and is not in any way a substitute for the Company's Consolidated Audited Financial Statements and notes thereto, MD&A and latest Annual Information Form (“AIF”), all of which can be found on the Company’s pro SEDAR+ at . About Crescita Therapeutics Inc. Crescita (TSX: CTX and OTC US: CRRTF) is a growth-oriented, innovation-driven Canadian commercial dermatology company with in-house R&D and manufacturing capabilities. The Company offers a portfolio of high-quality, science-based non-prescription skincare products and a commercial stage prescription product. We also own multiple proprietary transdermal delivery platforms that support the development of patented formulations to facilitate the delivery of active ingredients into or through the skin. For more information visit, . Forward-looking Information Certain statements in this press release constitute forward-looking statements and/or forward-looking information (collectively “forward-looking information”) within the meaning of applicable securities laws. All information in this press release, other than statements of current and historical fact, represents forward-looking information and is qualified by this cautionary note. Forward-looking information may relate to the Company’s future financial outlook and anticipated events or results and may include information regarding the Company’s financial position, business strategy, growth strategies, addressable markets, budgets, operations, financial results, taxes, dividend policy, plans, objectives, and expectations. Such information is provided for the purpose of presenting information about management’s current expectations and plans relating to the future and allowing investors and others to get a better understanding of the Company’s anticipated financial position, results of operations and operating environment. Readers are cautioned that such information may not be appropriate for other purposes. Often, but not always, forward-looking information can be identified by the use of forward-looking terminology such as: “outlook”, “objective”, “anticipate”, “intend”, “plan”, “goal”, “seek”, “believe”, “aim”, “project”, “estimate”, “expect”, “strategy”, “future”, “likely”, “may”, “should”, “will”, “growth strategy”, “future”, “prospects”, “continue”, and similar references to future periods or suggesting future outcomes or events. In addition, any statements that refer to expectations, intentions, projections or other characterizations of future events or circumstances contain forward-looking information. Examples of forward-looking information include, but are not limited to, statements made in this press release under the heading “Financial Highlights”, including statements regarding the Company’s objectives, plans, goals, strategies, growth, performance, operating results, financial condition, business prospects, opportunities and industry trends, and similar statements concerning anticipated future events, results, circumstances, performance or expectations. Forward-looking information is neither historical fact nor assurance of future performance. Instead, it reflects management’s current beliefs, expectations and assumptions and is based only on information currently available to us. Forward-looking information is necessarily based on a number of estimates and assumptions that, while considered reasonable by management of the Company as of the date of this press release, are inherently subject to significant business, economic, and competitive uncertainties and contingencies that are difficult to predict and many of which are outside of our control. The Company’s estimates, beliefs and assumptions, which may prove to be incorrect, include various assumptions regarding, among other things: the Company’s future growth potential, results of operations, future prospects and opportunities; the Company’s ability to retain and recruit, as applicable, customers, members of management and key personnel; industry trends; legislative or regulatory matters, including expected changes to laws and regulations and the effects of such changes; future levels of indebtedness; availability of capital; the Company’s ability to secure additional capital and source and complete acquisitions; the Company’s ability to maintain and expand its market presence and geographic scope; current economic conditions; the impact of currency exchange and interest rates; the Company’s ability to maintain existing financing and insurance on acceptable terms; the Company’s ability to execute on, and the impact of, its environmental, social and governance initiatives; the impact of competition; and the Company’s ability to respond to changes to its industry and the global economy. Forward-looking information involves risks and uncertainties that could cause Crescita’s actual results and financial condition to differ materially from those contemplated by such forward-looking information. Important factors that could cause such differences include, among others: economic and market conditions, including factors impacting global supply chains such as pandemics and geopolitical conflicts and tensions, including the uncertainty created by the war in Ukraine and the Israel-Hamas war; the impact of inflation and rising interest rates together with the threats of stagflation or recession; the Company’s ability to execute its growth strategies; the degree or lack of market acceptance of the Company’s products; reliance on third parties for marketing, distribution and commercialization, and clinical trials; the impact of variations in the values of the Canadian dollar in relation to the U.S. dollar and Euro; the impact of the volatility in financial markets; the Company’s ability to retain members of its management team and key personnel; the impact of changing conditions in the regulatory environment and product development processes; manufacturing and supply risks; increasing competition in the industries in which the Company operates; the Company’s ability to meet its contractual obligations; the impact of product liability matters; the impact of litigation involving the Company and/or its products; the impact of changes in relationships with customers and suppliers; the degree of intellectual property protection of the Company’s products; developments and changes in applicable laws and regulations, and; other risk factors described from time to time in the reports and disclosure documents filed by Crescita with Canadian securities regulatory agencies and commissions, including the sections entitled “Risk Factors” in the Company’s most recent annual MD&A and AIF. If any risks or uncertainties with respect to the above materialize, or if the opinions, estimates or assumptions underlying the forward-looking information prove incorrect, actual results or future events might vary materially from those anticipated in the forward-looking information. This list is not exhaustive of the factors that may impact the Company’s forward-looking information. Although management has attempted to identify important risk factors that could cause actual results to differ materially from those contained in forward-looking information, there may be other risk factors not presently known or that management believes are not material that could also cause actual results or future events to differ materially from those expressed in such forward-looking information. There can be no assurance that such information will prove to be accurate, as actual results and future events could differ materially from those anticipated in such information. Accordingly, investors should not place undue reliance on forward-looking information, which speaks only as of the date provided, and is subject to change after such date. Except as required by applicable securities laws, the Company undertakes no obligation to publicly update any forward-looking information, whether written or oral, that may be provided from time to time, whether as a result of new information, future developments or otherwise. 1 Please refer to the Non-IFRS Financial Measures section of this press release. ​ View source version on businesswire.com: Contacts FOR MORE INFORMATION, PLEASE CONTACT: Linda Kisa, CPA, CA Vice-President, Reporting and Corporate Affairs Email: lkisa@crescitatx.com Source: Crescita Therapeutics ​ View this news release online at:

进入2024年以来，三家Biotech的多轮融资将酪氨酸激酶2（TYK2）靶点的热度再次点燃。2024年1月，Sudo Biosciences宣布完成了第二次B轮融资，并在2月额外筹集了3000万美元，使这家TYK2开发公司的B轮融资额达到了1.47亿美元。同样在1月份，TYK2公司Myrobalan Therapeutics宣布完成2400万美元的A轮融资，用于开发口服神经修复疗法，包括用于减少神经炎症的TYK2变构抑制剂。2024年3月，一家开发口服疗法的临床阶段生物制药公司Alumis宣布完成2.59亿美元C轮融资。据Fierce Biotech统计，这是2024年迄今为止私营生物技术公司获得的最大融资金额。而此次融资主要用于TYK2抑制剂ESK-001以及A-005的研发。值得一提的是，ESK-001最初由中国创新药企海思科研发。那么，TYK2有何魅力，使得布局药企能够逆势多轮融资？01.难逃黑框警告的JAK抑制剂谈到TYK2，就不得不提JAK。TYK2是JAK家族的一员，由于发现时间早，当时还没有JAK家族的概念，所以并没有按照JAK的命名方式，因此，TYK2成为了整个家族里的“异类”。JAK全称为Janus Kinase，共有JAK1、JAK2、JAK3和TYK2四个家族成员。其中JAK1、JAK2和TYK2在人体各组织细胞中均有表达，JAK3主要表达于各造血组织细胞。作为JAK-STAT信号通路的核心，JAK家族激酶参与了细胞增殖、分化、凋亡以及免疫调节等多种重要的生物学过程。因此，只要抑制JAK激酶，就可以阻碍相关肿瘤、血液系统疾病、类风湿性关节炎等疾病的发生。进入21世纪以来，JAK激酶家族成为药物研发的热点，也取得了不少成果。2011年11月，全球第一款JAK抑制剂Ruxolitinib（芦可替尼）获FDA批准上市，由Incyte和诺华公司联合开发，用于治疗中高危骨髓纤维化患者。截至目前，全球共有11款JAK抑制剂成功获批上市。全球已获批上市JAK抑制剂来源：药渡数据已获批上市的JAK抑制剂基本分为两代，第一代是非选择性JAK抑制剂，同时靶向2个及以上JAK靶点，在展现出强大疗效的同时，由于脱靶效应较为严重，也引起了包括严重感染、肿瘤在内的多种严重不良反应，因此被FDA给予黑框警告；为了降低不良反应，艾伯维、BMS等相继推出第二代高抑制剂性JAK抑制剂，提高了对JAK1-3中特定一或二个亚型的选择性抑制，相较于第一代JAK抑制剂，其心血管、感染风险等均显著降低，但仍难逃FDA的黑框警告。基于此，针对性的研发选择性更强的JAK抑制剂就成为各大药企迭代的方向。随着2022年9月，BMS的TYK2抑制剂Deucravacitinib（氘可来昔替尼，Sotyktu）获FDA批准上市，成为目前唯一一款不附带任何黑框警告的JAK抑制剂。自此，属于TYK2靶点的想象空间，展开了。02.TYK2为何能逃脱家族宿命？从靶点来说，与JAK1-3家族成员参与更广泛的全身信号通路不同，TYK2几乎只影响免疫相关信号传导，比如仅能介导IL-23、IL-12和I型干扰素等细胞因子，促进IL-17、IL-23等炎症性细胞因子的生成（自免关键通路），对其他细胞因子干扰较小，因此成药安全性高。除了靶点本身的作用机制外，变构抑制剂的出现也助TYK2找到了制胜之道。JAK家族中的四个成员JAK1、JAK2、JAK3以及TYK2都有同源结构域（JH）组成，其中JH1结构域也称为激酶域，负责与ATP结合，调控JAK激酶活性。此前开发的JAK抑制剂多采用竞争性抑制，即通过与JH1结构域结合，来阻止其与ATP结合，从而抑制JAK激酶活化。由于不同JAK家族成员的JH1结构域高度相似，因此很容易产生脱靶现象，产生毒副作用。与JAK1-3成员不同的是，TYK2具有一个独特的JH2结构域，即调控JH1激酶活性的伪激酶结构域。根据JAK-STAT信号通路机制，JAK家族激酶需要先与ATP结合并磷酸化，才能激活下游的JAK-STAT信号通路传导炎症信号。那么如果有小分子配体结合到TYK2的JH2结构域，就能够使活性结构域的构象发生变化，使其无法和ATP结合。这种机制就是“变构抑制”的起效原理。而且TYK2的JH2结构域十分独特，因此专门针对它的小分子配体不太会像竞争性抑制剂那样脱靶到其他JAK家族成员。BMS的Deucravacitinib即是全球首个TYK2 JH2抑制剂。其通过与TYK2的JH2结合，使TYK2呈非活性构象，进而只阻断TYK2所支配的IL-23、 IL-12和I型干扰素的信号传导，并不会抑制其他的JAK通路，在保持药效的基础上避免了JAK1-3相关的不良反应。03.TYK2抑制剂，大有可为Deucravacitinib于2022年获FDA批准上市后迅速放量，BMS预测其销售峰值有望达到40亿美元。Deucravacitinib给JAK抑制剂的开发带来了革命性的变化。目前，国内外已有多家药企布局TYK2赛道。如武田在2022年12月豪掷60亿美元从Nimbus Therapeutics手中收购一款在研TYK2变构抑制剂TAK-279，首付款就高达40亿美元。去年3月，武田公布了TAK-279在中重度斑块状银屑病患者中的IIb期临床结果：该研究达到其主要和次要终点。目前，TAK-279正在进行一项评估其治疗中至重度斑块状银屑病的疗效、安全性和耐受性的III期临床研究。辉瑞在TYK2抑制剂的研发上选择了双靶点抑制剂来提高疗效。其在研产品Brepocitinib是一款JAK1/TYK2双重抑制剂，可与TYK2和JAK1催化结构域中的活性位点结合。目前，Brepocitinib在研的适应症有十余种。在海外众多药企进行布局的同时，国内也有不少药企跟进。如前面提到的TYK2变构抑制剂ESK-001，原本由本土药企海思科研发。2021年3月，海思科下属子公司FT集团以首付6000万美元，潜在交易1.2亿美元里程碑，将ESK-001所属专利和权益转让给了Alumis公司。今年3月，Alumis公司在美国皮肤病学会 (AAD) 年会上公布了ESK-001用于治疗中重度斑块状银屑病患者的II期临床结果。总体来看，研究达到主要终点和所有关键次要终点，药物安全性良好。诺诚健华在TYK2赛道中研发进度较为靠前。其在研TYK2抑制剂ICP-332在中重度特应性皮炎患者中的II期临床试验已取得积极结果，是目前全球特应性皮炎适应症进度靠前的TYK2抑制剂。此外，诺诚健华还有一款TYK2变构抑制剂ICP-488，适应症为银屑病，目前处于临床I期。国内还有高光制药的TLL-018（JAK1/TYK2抑制剂）、启元生物的QY201（JAK1/TYK2抑制剂）、爱科诺生物的AC-201（JAK1/TYK2抑制剂）、益方生物的D-2570（TYK2抑制剂）、安锐生物的ARTS-011（TYK2抑制剂）等处于II期临床阶段。TYK2抑制剂目前是多种严重炎症和自身免疫性疾病的重点开发方向。据弗若斯特沙利文的数据，到2030年，仅中国自免药物市场规模就达到230亿美元。在这片波澜壮阔的蓝海市场中，没有黑框警告的TYK2抑制剂，将大有可为。参考来源1.各企业公告2.Morris R, Kershaw N J, Babon J J. The molecular details of cytokine signaling via the JAK/STAT pathway[J]. Protein Science, 2018, 27(12): 1984-2009.3.https://www.businesswire.com/news/home/20221213005639/en.4.https://www.takeda.com/newsroom/newsreleases/2023/takeda-announces-positive-results-in-phase-2b-study-of-investigational-tak-279.AACR年会透露出的小分子肿瘤学药物前景强生Q1强势开局：营收超200亿美元，Carvykti飙升118%！巴瑞替尼专利攻防，晶型专利迎来无效挑战点击蓝字 关注我们