Tivumecirnon Besylate

SOUTH SAN FRANCISCO, Calif., Aug. 08, 2024 (GLOBE NEWSWIRE) -- RAPT Therapeutics, Inc. (Nasdaq: RAPT), a clinical-stage, immunology-based therapeutics company focused on discovering, developing and commercializing oral small molecule therapies for patients with significant unmet needs in inflammatory diseases and oncology, today reported financial results for the second quarter and six months ended June 30, 2024. “We continue to analyze the data from our two Phase 2 trials of zelnecirnon (RPT193) in atopic dermatitis and asthma, which we closed prior to completing enrollment following the clinical holds placed by the FDA in February,” said Brian Wong, President and CEO. “We anticipate that our analysis of the data will be completed this quarter.” Financial Results for the Second Quarter and Six Months Ended June 30, 2024 Second Quarter Ended June 30, 2024 Net loss for the second quarter of 2024 was $27.7 million, compared to $25.3 million for the second quarter of 2023. Research and development expenses for the second quarter of 2024 were $22.6 million, compared to $21.6 million for the same period in 2023. The increase in research and development expenses was primarily due to higher development costs related to zelnecirnon, as well as increased expenses for personnel, consultants, facilities and non-cash stock-based compensation, partially offset by decreases in development costs related to tivumecirnon and early-stage programs as well as lab supplies costs. General and administrative expenses for each of the second quarter of 2024 and 2023 were $6.7 million, respectively. General and administrative expenses were unchanged as increased expenses for personnel and non-cash stock-based compensation were offset by decreases in expenses for consultants and insurance premiums. Six Months Ended June 30, 2024 Net loss for the second quarter of 2024 was $58.2 million, compared to $54.6 million for the second quarter of 2023. Research and development expenses for the six months ended June 30, 2024 were $47.4 million, compared to $47.2 million for the same period in 2023. The increase in research and development expenses was primarily due to increased expenses for personnel, consultants, facilities and non-cash stock-based compensation, partially offset by decreases in development costs related to zelnecirnon, tivumecirnon, early-stage programs and lab supplies costs. General and administrative expenses for the six months ended June 30, 2024 were $14.4 million, compared to $12.7 million for the same period in 2023. The increase in general and administrative expenses was primarily due to increased expenses for personnel, non-cash stock-based compensation and facilities, partially offset by decreases in expenses for consultants and insurance premiums. As of June 30, 2024, the Company had cash and cash equivalents and marketable securities of $114.8 million. On July 16, 2024, the Company’s board of directors approved a reduction of the Company’s workforce to conserve cash resources. The workforce reduction affected 47 people, or approximately 40% of the Company’s headcount. The Company estimates that it will incur approximately $0.9 million in restructuring charges in connection with the workforce reduction, consisting of cash-based expenses related to employee severance payments, benefits and related costs. The Company expects that the execution of the workforce reduction and the majority of the cash payments related to the restructuring will be substantially completed by the end of the third quarter of 2024. About RAPT Therapeutics, Inc. RAPT Therapeutics is a clinical-stage, immunology-based therapeutics company focused on discovering, developing and commercializing oral small molecule therapies for patients with significant unmet needs in inflammatory diseases and oncology. Utilizing its proprietary discovery and development engine, the Company is developing highly selective small molecules designed to modulate the critical immune drivers underlying these diseases. RAPT has discovered and advanced two unique drug candidates, zelnecirnon (RPT193) and tivumecirnon (FLX475), each targeting C-C motif chemokine receptor 4 (CCR4), for the treatment of inflammation and cancer, respectively. The Company is also pursuing a range of targets that are in the discovery stage of development. Forward-Looking Statements This press release contains forward-looking statements within the meaning of the Private Securities Litigation Reform Act of 1995. Words such as “anticipate,” “estimates,” “expects,” “will” and similar expressions (as well as other words or expressions referencing future events, conditions or circumstances) are intended to identify forward-looking statements. These statements relate to future events and involve known and unknown risks, uncertainties and other factors that may cause our actual results, performance or achievements to be materially different from any future performances or achievements expressed or implied by the forward-looking statements. Each of these statements is based only on current information, assumptions and expectations that are inherently subject to change and involve a number of risks and uncertainties. Forward-looking statements include, but are not limited to, statements about the Company’s expectations concerning the clinical holds of its Phase 2 trials of zelnecirnon, including its investigation of the incident, its analysis of the data from the unblinded trials and the timing thereof, its ability to resolve issues to the FDA’s satisfaction and the availability of updates concerning such process, statements regarding the workforce reduction and estimated costs associated with that reduction, and other statements that are not historical fact. Many factors may cause differences between current expectations and actual results, including unexpected or unfavorable safety or efficacy data observed during clinical studies, preliminary data and trends that may not be predictive of future data or results or that may not demonstrate safety or efficacy or lead to regulatory approval, the inability to resolve issues related to the clinical holds on the Phase 2 trials of zelnecirnon to the FDA’s satisfaction and to ultimately resume such trials, clinical trial site activation or enrollment rates that are lower than expected, unanticipated or greater than anticipated impacts or delays due to macroeconomic conditions (including the long-term impacts of ongoing overseas conflicts, inflation, higher interest rates and other economic uncertainty), changes in expected or existing competition, changes in the regulatory environment, the uncertainties and timing of the regulatory approval process and the sufficiency of RAPT’s cash resources. Detailed information regarding risk factors that may cause actual results to differ materially from the results expressed or implied by statements in this press release may be found in RAPT’s Quarterly Report on Form 10-Q filed with the Securities and Exchange Commission on August 8, 2024 and subsequent filings made by RAPT with the Securities and Exchange Commission. These forward-looking statements speak only as of the date hereof. RAPT disclaims any obligation to update these forward-looking statements, except as required by law. RAPT Media Contact: Aljanae Reynolds areynolds@wheelhouselsa.com RAPT Investor Contact: Sylvia Wheeler swheeler@wheelhouselsa.com RAPT THERAPEUTICS INC.CONSOLIDATED STATEMENTS OF OPERATIONS AND COMPREHENSIVE LOSS(In thousands, except share per share data)(Unaudited) Three Months EndedJune 30, Three Months EndedJune 30, Six Months EndedJune 30, Six Months EndedJune 30, 2024 2023 2024 2023 Operating expenses: Research and development 22,640 21,642 47,421 47,216 General and administrative 6,690 6,722 14,427 12,710 Total operating expenses 29,330 28,364 61,848 59,926 Loss from operations (29,330) (28,364) (61,848) (59,926)Other income, net 1,667 3,084 3,664 5,375 Net loss $(27,663) $(25,280) $(58,184) $(54,551)Other comprehensive income (loss): Foreign currency translation loss — (655) — (655)Unrealized gain (loss) on marketable securities (37) 136 (150) 501 Total comprehensive loss $(27,700) $(25,799) $(58,334) $(54,705)Net loss per share, basic and diluted $(0.71) $(0.66) $(1.50) $(1.42)Weighted average number of shares used in computingnet loss per share, basic and diluted 38,866,760 38,328,741 38,748,214 38,304,758 RAPT THERAPEUTICS, INC.CONSOLIDATED BALANCE SHEETS(In thousands) June 30,2024 December 31,2023 Assets (Unaudited) (1) Current assets: Cash and cash equivalents $37,077 $47,478 Marketable securities 77,761 111,384 Prepaid expenses and other current assets 5,658 2,920 Total current assets 120,496 161,782 Property and equipment, net 1,933 2,448 Operating lease right-of-use assets 4,304 5,228 Other assets 447 3,871 Total assets $127,180 $173,329 Liabilities and stockholders’ equity Current liabilities: Accounts payable $2,716 $5,176 Accrued expenses 9,487 14,103 Operating lease liabilities, current 2,568 2,448 Other current liabilities 30 109 Total current liabilities 14,801 21,836 Operating lease liabilities, non-current 3,159 4,458 Total liabilities 17,960 26,294 Commitments Stockholders’ equity: Preferred stock — — Common stock 3 3 Additional paid-in capital 652,130 631,611 Accumulated other comprehensive gain (loss) (47) 103 Accumulated deficit (542,866) (484,682) Total stockholders’ equity 109,220 147,035 Total liabilities and stockholders’ equity $127,180 $173,329 (1) The consolidated balance sheet for December 31, 2023 has been derived from audited consolidated financial statements included in the Company’s Annual Report on Form 10-K for the year ended December 31, 2023.

来源：药渡 撰文：五月     编辑：维他命 七月，进行裁员的药企数目有所增加，至少有16家公司公布了裁员计划，如下表所示。 表1. 7月药企裁员名单 7月29日 总部位于波士顿的Cue Biopharma周四宣布，优先事项将发生变化，将需要裁员四分之一。Cue将把资源集中在其自身免疫项目上，同时寻求合作伙伴继续开发其肿瘤候选药物，此次重组将把Cue的现金跑道延长至2025年中期。截至公告发布前一天，Cue拥有约50名员工。 7月26日 总部位于瑞士和马萨诸塞州的公司Anokion的一位发言人告诉Fierce Biotech，该公司将裁员，人数不详。Anokion计划将资源集中在其主要候选药物KAN-101上，这是一种治疗乳糜泻的药物，目前处于临床II期（图1）。 图1. Anokion研发管线 7月26日 在与FDA会面并确定其复发和难治性急性髓性白血病（AML）的候选药物需要额外的临床试验后，总部位于马里兰州罗克维尔的GlycoMimetics宣布将裁员约80%。 GlycoMimetics在周四的一份公告中表示，还将就如何最好地向前发展进行战略审查，紧接着周五在提交给美国证券交易委员会的一份文件中透露，该公司于6月份接到纳斯达克的通知，其股价已跌破1美元/股。截至2023年底，GlycoMimetics拥有35名全职员工。 7月26日 总部位于马萨诸塞州剑桥的Relay Therapeutics的一位发言人告诉Fierce Biotech，该公司将解雇300名员工中不到5%的员工。 该公司专注于精准肿瘤学和遗传疾病，本月早些时候终止了与基因泰克公司关于小分子癌症药物开发和商业化的协议。但这位发言人告诉Fierce，裁员与该交易的解散无关。 7月24日 据STAT周三报道，默克公司本周解雇了大约75至80人。据该出版物称，裁员涉及多个集团，影响了该公司的早期研究部门。 7月22日 总部位于南旧金山的生物技术公司Rapt Therapeutics在7月19日提交给美国证券交易委员会（SEC）的一份文件中透露，该公司将“裁员47人，约占公司现有员工人数的40%”，以节省现金资源。 Rapt Therapeutics在2月份遭遇挫折，当时FDA在肝衰竭病例后暂停了其候选药物zelnecirnon的两项II期试验。除了正在开发用于治疗哮喘和特应性皮炎的zelnecirnon外，Rapt还有第二个临床阶段的候选药物tivumecirnon正在进行癌症试验（图2）。 图2. Rapt Therapeutics的研发管线 7月18日 总部位于新加坡的生物制药公司Aslan Pharmaceuticals周三宣布，该公司正在清算其资产，并解雇了所有员工。 根据公告，其董事已确定“ASLAN SG因其负债而无法继续其业务”。该公司还表示，由于“未能满足持续的上市要求”，它已于7月15日收到纳斯达克的退市决定，并选择不要求就该决定举行听证会。 根据美国证券交易委员会的一份文件，截至2023年底，Aslan在新加坡有20名员工，在美国有14名员工，在英国有1名员工。 7月16日 Caribou Biosciences周二向美国证券交易委员会（SEC）报告称，该公司已裁员21名员工（占其员工总数的12%），因为它停止了同种异体CAR-NK疗法的临床前开发。 该文件补充说，裁员将在第三季度末完成，其现金跑道将延长至2026年下半年，因为它将资源集中在其同种异体（或现成的）CAR-T细胞治疗平台上。 7月12日 据Endpoints News周四报道，罗氏的Spark Therapeutics正在裁员并停止其一些早期项目。这家总部位于费城的基因治疗生物技术公司的发言人透露，该公司正在调整其战略，以“加速其管道并更快地为患者带来更多疗法，但此举将包括'组织变革'。本周发出了有关就业的通知，但没有说明有多少人会被解雇。 Spark在其管线中有两个血友病A和血友病B的后期试验，以及治疗庞贝病的早期资产（图3）。Spark拥有约800名员工，于2019年被罗氏以约48亿美元的价格收购。 图3. Spark的研发管线 7月11日 据《圣地亚哥联合论坛报》（San Diego Union-Tribune）周三报道，诺华已经解雇了圣地亚哥的29名员工，并将在关闭其开发基地时再裁减约100个工作岗位。 诺华发言人在一封电子邮件中告诉该媒体，“将在未来2到3年内实施一系列变革，以建立全球人才库，同时在某些地方建立和减少职位。 今年4月，路透社报道称，诺华计划在全球范围内裁员数百个开发工作岗位，其中包括美国的240个工作岗位。 7月11日 总部位于弗吉尼亚州的Indivior宣布，该公司将停止销售和营销其精神分裂症药物Perseris，并解雇约130名销售人员。Indivior是一家全球性的制药公司，专注于开发药物使用障碍和其他严重精神疾病的治疗方法。Indivior将此次裁员决定归结于市场竞争激烈导致的变化。 7月3日 肿瘤生物制药公司Apollomics宣布，该公司将解雇其领导团队的两名成员以及数量不详的员工。 “由于更新了战略重点，并与公司未来的资源需求保持一致，公司联合创始人兼总裁Sanjeev Redkar博士和首席医疗官Peony Yu医学博士预计将在8月过渡到咨询角色，”公告称，还注意到“其他员工”的离职。这些减少与该公司缩小其候选药物vebreltinib的目标患者群体有关，该药物目前正处于某些肿瘤的II期临床试验中。 7月3日 这家德国公司宣布，CureVac将减少30%的员工队伍，因为它重组了与葛兰素史克（GSK）的mRNA合作。两家公司于2020年开始合作开发mRNA疫苗，并正在开发季节性流感、COVID-19和禽流感的候选疫苗。根据新协议，GSK将完全控制这些候选疫苗的开发和生产。 与此同时，CureVac表示，其裁员将“创建一个更精简、更敏捷的组织，重新专注于技术创新、研究和开发”，并将其现金跑道延长至2028年。 根据美国证券交易委员会的一份文件，截至2023年底，CureVac在全球拥有1,172 名员工，并且已经在4月份通过“自愿离职”计划裁员约150人。 7月2日 在6月27日的WARN通知中，武田透露将在马萨诸塞州再裁员220人。其中，189人将从剑桥的职场被解雇，列克星敦职场31人被解雇。 总的来说，武田现在已经裁员或宣布计划在2024年裁员1,300多人，此外已经在2023年进行过裁员。 武田发言人在一份电子邮件声明中告诉Endpoints，该公司正在优先考虑“提高组织敏捷性，节省采购成本，并加强我们在武田利用数据、数字和技术的工作方式。随着我们继续努力使这些举措取得成果，我们也需要做出艰难的选择，一些员工将因此受到影响”。 7月1日 总部位于马萨诸塞州沃尔瑟姆的Aerovate Therapeutics公司于6月25日向美国证券交易委员会（SEC）披露，该公司将在未来几个月内裁员掉“几乎所有员工”，此前该公司的肺动脉高压候选药物IIb期失败。Aerovate补充说，目前已经通知了39人（占其员工总数的78%）。 7月1日 瑞士生物技术公司GeNeuro宣布，在其长效COVID候选药物临床II期失败后，该公司将解雇除两名员工以外的所有员工。 公告称，GeNeuro“已裁员9份雇佣协议中的7份，包括所有执行管理层”。“所有员工和管理人员都将在长达6个月的通知期内工作，以执行董事会将在未来几天内制定的战略。” 参考文献： 1.https://www.biospace.com/article/biospace-layoff-tracker-2023-athenex-shutters-facility-cuts-staff/ 专栏作者 五月 药物化学硕博，国外博士后，现从事药物研发工作，热爱医药行业，愿与各位同行互相学习、进步，共同见证创新药的发展。 *声明：本文仅是介绍医药疾病领域研究进展或简述研究概况或分享医药相关讯息，并非也不会进行治疗或诊断方案推荐，也不对相关投资构成任何建议。内容如有疏漏，欢迎沟通指出！ 自免和癌症NK细胞疗法新秀IPO上市 2024年7款核药交易 2024年重磅研发管线TOP10：减肥赛道异军突起，肿瘤、精神药物多点开花