Erlotinib Hydrochloride

癌度医学临床招募资讯微信群（点击）对于存在EGFR基因突变的非小细胞肺癌，靶向药治疗是一线治疗的主要策略。在靶向药选择上可选第一代靶向药吉非替尼或厄洛替尼，也可以直接使用第三代靶向药奥希替尼。由于不管使用哪一种靶向药都不可避免耐药的问题，所以预防或克服靶向药的获得性耐药就成了提高患者生存期的重要问题。一线治疗中，铂类化疗联合EGFR靶向药可以延长肺腺癌患者的生存期。一项来自日本的多中心三期临床试验表明，第一代靶向药吉非替尼联合铂类双药化疗的无进展生存期显著优于吉非替尼单药，但是总生存期没有显著差异。来自印度的一项三期临床试验则表明，相同的治疗方案在无进展生存期和总生存期都具有优势，所以靶向药联合化疗是否总生存期更好还不能完全确定。1、靶向药和化疗的联合治疗缘起为什么要将靶向药和化疗联合使用，这里其实有相应的机制。有研究表明，将EGFR靶向药和化疗联合使用时，靶向药能减弱化疗药物的副作用。但是截止目前靶向药和化疗的同步使用总生存期数据是没有显著差异的。最近有一项发布在学术期刊的文章做了一项三期临床试验，研究者假设在EGFR靶向药初步治疗期间插入铂类双药化疗可预防靶向药的耐药，从而延长患者的生存期。而且肿瘤细胞对靶向药产生了应答，将化疗药物用上去之后可能更加有效，原因是EGFR靶向药减轻了肿瘤的负荷，所以化疗药物的效果也更好。这个治疗方案的二期临床试验使用吉非替尼联合顺铂加多西他赛一线治疗晚期肺癌，中位无进展生存时间达到了19.5个月，中位总生存时间达到了48个月，这是相当不错的数据，下面这部分内容是这个治疗方案的三期临床试验。本文参考文献刊例示意图2、与化疗搭配的靶向药延长了无进展生存期这是一项开放标签，多中心的随机三期临床试验，招募的是EGFR基因19外显子缺失突变和L858R突变的晚期肺腺癌患者，这些患者确诊后未使用任何系统治疗。患者等比例分组，一组患者一线使用靶向药治疗，另外一组患者则是使用靶向药联合化疗治疗。2015年12月至2020年10月期间，共计入组了501名患者。308名患者使用了一代靶向药吉非替尼，193名患者使用的是三代靶向药奥希替尼。联合用药的方式是：第1天至第56天给予靶向药治疗，然后停药2周时间，在第71天、第92天、第113天给予3个疗程的顺铂和培美曲塞。在第134天重新开始使用EGFR靶向药，一直到病情进展。靶向药和化疗联合延长了无进展生存期如上面的图示，如果是EGFR靶向药单药治疗的中位无进展生存期是12个月，而将EGFR靶向药和化疗搭配使用则中位无进展生存期达到了18个月。其中吉非替尼单药治疗的中位无进展生存期是9.5个月，而吉非替尼和化疗联合治疗的中位无进展生存期是14.4个月。而三代靶向药奥希替尼的区别就不明显，尽管靶向药单药和靶向药与化疗联合治疗的中位无进展生存期分别是20.4个月和25.2个月，但是两个曲线是没有显著拉开。3、总生存时间没有显著差异如果说到总生存期数据，那么可能就有点让人失望。因为没有显示出明显的区别。我们看下面的图示，不管是吉非替尼还是奥希替尼，总生存期曲线都没有明显地拉开。靶向药和化疗联合的总生存期数据癌度精选文章曾经有一个内容是源自这个治疗措施的二期临床试验，从逻辑上讲这个先靶向药后化疗，然后继续靶向药确实是延长了中位无进展生存期。尤其是将第一代靶向药吉非替尼用成了三代靶向药的效果。但是总生存期可能是没有显著拉开。当然患者总生存期的影响因素比较多，比如上面的研究患者病情进展之后用了什么治疗策略是多种多样的。上面的这个研究将具体用药措施写的很清楚，这个是可能很多患者对联合治疗误解地方，不是将靶向药和铂类化疗一直用个没完没了，那样患者所出现的不良反应会比较多，体质越来越差，对于后面的治疗是有影响的。究竟是不是选择靶向药和化疗搭配使用大家可以与主治医生沟通做决定，关于靶向药和化疗的联合使用、基因检测报告解读等问题欢迎大家加入癌度病友群交流。参考文献：Shintaro Kanda, et al, Randomized Phase III Study of EGFR Tyrosine Kinase Inhibitor and Intercalated Platinum-Doublet Chemotherapy for Non–Small Cell Lung Cancer Harboring EGFR Mutation, Clin Cancer Res; 2025. 往期推荐 胃癌进展后无药可用？新型CAR-T疗法IMC 001让90%的患者病情得以控制，有患者争取到手术机会!突破！80%实体瘤存在同一靶点PRL3，国际二期试验公布抗癌新药数据解决奥希替尼多种耐药位点，第四代EGFR靶向药H002于美国和中国同时启动临床试验，专治C797S类耐药位点！广谱抗癌药组合，奥拉帕利联合帕博利珠单抗有望成为BRCA1/2突变实体肿瘤的标准疗法！

NESS ZIONA, Israel, May 23, 2025 (GLOBE NEWSWIRE) -- Sol-Gel Technologies, Ltd. (NASDAQ: SLGL), a clinical-stage dermatology company, today announced financial results for the first quarter ended March 31, 2025. Financial Results for the First Quarter Year Ended March 31st, 2025 Total revenue in the first quarter was $1 million compared to $0.5 million revenues for the same period in 2024. Research and development expenses were $8.8 million compared to $5.3 million in the same period in 2024. The increase of $3.5 million was primarily attributed to an increase of $3.6 million due to expenses associated with supplier-led manufacturing development to support future commercialization of SGT-610, an increase of $0.5 million related to the commercialization of EPSOLAY and TWYNEO in territories outside of the U.S., offset by a decrease of $0.5 million in clinical trial expenses related to SGT-610. General and administrative expenses were $1.3 million compared to $1.8 million for the same period in 2024. The decrease of $0.5 million was mainly attributed to a decrease in payroll and stock-based compensation expenses due to cost measures being taken in 2024. Sol-Gel reported a net loss of $8.8 million for the first quarter of 2025 and of $3.2 basic and diluted loss per share, compared to a net loss of $6.3 million and a loss of $2.3 per basic and diluted share for the same period in 2024. As of March 31, 2025, Sol-Gel had $16.9 million in cash, cash equivalents, and deposits and no marketable securities for a total balance of $16.9 million. The Company expects its cash resources to fund cash requirements into the first quarter of 2027. About Sol-Gel Technologies Sol-Gel Technologies, Ltd. is a dermatology company focused on identifying, developing and commercializing or partnering drug products for the treatment of skin diseases. Sol-Gel developed TWYNEO which is approved by the FDA for the treatment of acne vulgaris in adults and pediatric patients nine years of age and older; and EPSOLAY, which is approved by the FDA for the treatment of inflammatory lesions of rosacea in adults. The Company’s pipeline includes Orphan Drug candidate, SGT-610 under investigation for the prevention of new basal cell carcinomas in Gorlin syndrome patients, and also includes topical drug candidate SGT-210 under investigation for the treatment of rare skin keratodermas. For additional information, please visit www.sol-gel.com. Forward Looking Statements This press release contains “forward-looking statements” within the meaning of the Private Securities Litigation Reform Act of 1995. All statements contained in this press release that do not relate to matters of historical fact should be considered forward-looking statements, including, but not limited to our expected cash runway. In some cases, you can identify forward-looking statements by terminology such as “believe,” “may,” “estimate,” “continue,” “anticipate,” “intend,” “should,” “plan,” “expect,” “predict,” “potential,” or the negative of these terms or other similar expressions. Forward-looking statements are based on information we have when those statements are made or our management’s current expectations and are subject to risks and uncertainties that could cause actual performance or results to differ materially from those expressed in or suggested by the forward-looking statements. Important factors that could cause such differences include, but are not limited to, our ability to enter into further collaborations, lower than anticipated annual revenue income from new collaborations, a delay in the timing of our clinical trials, the success of our clinical trials, and an increase in our anticipated costs and expenses, as well as the following factors: (i) the adequacy of our financial and other resources, particularly in light of our history of recurring losses and the uncertainty regarding the adequacy of our liquidity to pursue our complete business objectives; (ii) our ability to complete the development of our product candidates; (iii) our ability to find suitable co-development partners; (iv) our ability to obtain and maintain regulatory approvals for our product candidates in our target markets, the potential delay in receiving such regulatory approvals and the possibility of adverse regulatory or legal actions relating to our product candidates even if regulatory approval is obtained; (v) our collaborators’ ability to commercialize our pharmaceutical product candidates; (vi) our ability to obtain and maintain adequate protection of our intellectual property; (vii) our collaborators’ ability to manufacture our product candidates in commercial quantities, at an adequate quality or at an acceptable cost; (viii) our collaborators’ ability to establish adequate sales, marketing and distribution channels; (ix) acceptance of our product candidates by healthcare professionals and patients; (x) the possibility that we may face third-party claims of intellectual property infringement; (xi) the timing and results of clinical trials that we may conduct or that our competitors and others may conduct relating to our or their products; (xii) intense competition in our industry, with competitors having substantially greater financial, technological, research and development, regulatory and clinical, manufacturing, marketing and sales, distribution and personnel resources than we do; (xiii) potential product liability claims; (xiv) potential adverse federal, state and local government regulation in the United States, China, Europe or Israel; and (xv) loss or retirement of key executives and research scientists; (xvi) general market, political and economic conditions in the countries in which the Company operates; and, (xvii) the current war between Israel and Hamas and any deterioration of the war in Israel into a broader regional conflict involving Israel with other parties. These factors and other important factors discussed in the Company's Annual Report on Form 20-F filed with the Securities and Exchange Commission (“SEC”) on April 29, 2025, and our other reports filed with the SEC, could cause actual results to differ materially from those indicated by the forward-looking statements made in this press release. Except as required by law, we undertake no obligation to update any forward-looking statements in this press release. SOL-GEL TECHNOLOGIES LTD.CONDENSED CONSOLIDATED BALANCE SHEETS(U.S. dollars in thousands)(Unaudited) December 31, March 31, 2024 2025Assets CURRENT ASSETS: Cash and cash equivalents$19,489 $16,890 Bank deposits 12 12 Marketable securities 4,425 - Accounts receivables 3,595 3,883 Prepaid expenses and other current assets 3,774 2,647 TOTAL CURRENT ASSETS 31,295 23,432 NON-CURRENT ASSETS: Restricted long-term deposits and cash equivalents 1,291 1,293 Long-term receivables 1,024 518 Property and equipment, net 202 183 Operating lease right-of-use assets 1,426 1,332 Other long-term assets 13 - Funds in respect of employee rights upon retirement 595 305 TOTAL NON-CURRENT ASSETS 4,551 3,631 TOTAL ASSETS$35,846 $27,063 Liabilities and shareholders' equity CURRENT LIABILITIES: Accounts payable$1,265 $438 Other accounts payable 3,590 3,702 Current maturities of operating leases 430 433 TOTAL CURRENT LIABILITIES 5,285 4,573 LONG-TERM LIABILITIES: Operating leases liabilities 878 746 Liability for employee rights upon retirement 833 363 Other long-term Liability 1,209 TOTAL LONG-TERM LIABILITIES 1,711 2,318 TOTAL LIABILITIES 6,996 6,891 SHAREHOLDERS' EQUITY: Ordinary shares, NIS 0.1 par value – authorized: 5,000,000 as of December 31, 2024 and March 31, 2025, respectively; issued and outstanding: 2,785,762 as of December 31, 2024 and March 31, 2025, respectively (*) 774 774 Additional paid-in capital 258,959 259,089 Accumulated deficit (230,883) (239,691) TOTAL SHAREHOLDERS' EQUITY 28,850 20,172 TOTAL LIABILITIES AND SHAREHOLDERS' EQUITY$35,846 $27,063 (*) All share amounts have been retroactively adjusted to reflect a 1-for-10 reverse share split. SOL-GEL TECHNOLOGIES LTD.CONDENSED CONSOLIDATED STATEMENTS OF OPERATIONS(U.S. dollars in thousands)(Unaudited) Three months endedMarch 31 2024 2025 LICENSE REVENUES$466 $1,031 RESEARCH AND DEVELOPMENT EXPENSES 5,345 8,843 GENERAL AND ADMINISTRATIVE EXPENSES 1,833 1,257 OPERATING LOSS 6,712 9,069 FINANCIAL INCOME,net (368) (261) LOSS FOR THE PERIOD 6,344 8,808 BASIC AND DILUTED LOSS PER ORDINARY SHARE 2.3 3.2 WEIGHTED AVERAGE NUMBER OF SHARES*OUTSTANDING USED IN COMPUTATION OF BASIC AND DILUTED LOSS PER SHARE (*) 2,785,762 2,785,762 (*)All share amounts have been retroactively adjusted to reflect a 1-for-10 reverse share split. Sol-Gel Contact:Eyal Ben-OrChief Financial Officerir@sol-gel.com+972-8-9313429Source: Sol-Gel Technologies Ltd.