425 1 ea0210021-425_biomotion.htm FORM 425

根据生物动态科学公司提出的诉讼

《证券法》第425条规定

主题 公司:Moringa收购公司

佣金 文件:001-40073

日期:2024年7月25日

 

在基因表达水平上沉默癌基因企业展示2024年7月由Biomotion Sciences根据1933年证券法规则425项提交。受让方公司:Moringa Acquisition Corp,委员会文件:001-40073,日期:2024年7月25日

 

 

DISCLAIMER • • • • • • • • • • • • • ABOUT THIS PRESENTATION • This investor presentation (this “Presentation”) is for informational purposes only to assist interested parties in making their own evaluation with respect to the proposed business combination (the “Business Combination”) between Moringa Acquisition Corp (“Moringa”) and Silexion Therapeutics Ltd. (together with its direct and indirect subsidiaries, collectively,“Silexion”). The information contained herein does not purport to be all - inclusive or necessarily contain all the information that a prospective investor may desire in investigating a prospective investment in the securities of Biomotion Sciences (“PubCo”), and none of Moringa, Silexion, PubCo or their respective representatives or affiliates makes any representation or warranty, express or implied, as to the accuracy, completeness or reliability of the information contained in this Presentation (and any other information, whether written or oral, that has been or will be provided to you). The information contained herein is preliminary and is subject to update, completion, revision, verification and amendment without notice, and such changes may be material. The attached material is provided to you on the understanding that as a sophisticated investor, you will understand and accept its inherent limitation, will not rely on it in making any investment decision with respect to any securities that may be issued, and will use it only for purposes of discussing with your advisors your preliminary interest in investing in PubCo in connection with the proposed Business Combination. No statement contained herein should be considered binding on any party. Completion of the proposed Business Combination is subject to, among other matters, approval by Moringa’s and Silexion’s shareholders and the satisfaction of the closing conditions to be set forth in the business combination agreement (“BCA”). No assurances can be given that the proposed Business Combination will be consummated on the terms or in the timeframe currently contemplated, if at all. NO OFFER OR SOLICITATION This Presentation does not constitute (i) a solicitation of a proxy, consent or authorization with respect to any securities or in respect of the proposed Business Combination or (ii) an offer to sell, a solicitation of an offer to buy or a recommendation to purchase any security of Moringa, Silexion or PubCo or any of their respective affiliates. Any offer to sell securities will be made only pursuant to a definitive subscription or similar agreement and will be made in reliance on an exemption from registration under the Securities Act of 1933, as amended, for offers and sales of securities that do not involve a public offering. You should not construe the contents of this Presentation as legal, tax, accounting or investment advice or a recommendation. You should consult your own counsel and tax and financial advisors as to legal and related matters concerning the matters described herein and, by accepting this Presentation, you confirm that you are not relying upon the information contained herein to make any decision. No representations or warranties, express or implied are given in, or in respect of, this Presentation. No securities commission or securities regulatory authority in the United States or any other jurisdiction has in any way passed upon the merits of the proposed Business Combination or the accuracy or adequacy of this Presentation. The distribution of this Presentation may also be restricted by law and persons into whose possession this Presentation comes should inform themselves of and observe any such restrictions. 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The information included in this Presentation in relation to Silexion has been provided by Silexion and its management team, and forward - looking statements include statements relating to the expectations of Silexion’s management team, hopes, beliefs, intentions or strategies regarding the future. In addition, any statements that refer to projections, forecasts or other characterizations of future events or circumstances, including any underlying assumptions, are forward - looking statements. The words “anticipate,” “believe,” “continue,” “could,” “estimate,” “expect,” “intends,” “may,” “might,” “plan,” “possible,” “potential,” “predict,” “project,” “should,” “would” and similar expressions may identify forward - looking statements, but the absence of these words does not mean that a statement is not forward - looking. Forward - looking statements in this proxy statement may include, for example, statements about Moringa’s ability to complete the Business Combination, or, if it does not consummate the Business Combination, any other initial business combination; the benefits of the Business Combination; the future performance of Silexion following the Business Combination, including Silexion’s projected timeline for regulatory submissions and approvals; and Silexion’s future plans and opportunities. The forward - looking statements contained in this Presentation are based on our current expectations and beliefs concerning future developments and their potential effects on us. There can be no assurance that future developments affecting Silexion will be those that it has anticipated. These forward - looking statements involve a number of risks, uncertainties (some of which are beyond the control of Silexion) or other assumptions that may cause actual results or performance to be materially different from those expressed or implied by these forward - looking statements. These risks and uncertainties include, but are not limited to, the items in the following list, which summarize some of the principal risks relating to the Business Combination and Moringa’s and Silexion’s businesses: (i) the conditions to the closing of the Business Combination may not be fulfilled, or may be waived, (ii) the occurrence of any event, change or other circumstances that could give rise to the termination of the BCA, (iii) Moringa may not succeed at having the Moringa ordinary shares and Moringa warrants remain listed on Nasdaq until completion of the Business Combination, (iv) the ability to fulfill the Nasdaq listing conditions and/or maintain the listing of Pubco ordinary shares on the Nasdaq following the Business Combination, (v) Silexion is a development - stage company and has a limited operating history on which to assess its business; (vi) Silexion has never generated any revenue from product sales and may never be profitable, (vii) Pubco will need to raise substantial additional funding, which may not be available on acceptable terms, or at all, and which will cause dilution to Pubco’s shareholders; (viii) the approach Silexion is taking to discover and develop novel RNAi therapeutics is unproven for oncology and may never lead to marketable products; (ix) Silexion does not have experience producing its product candidates at commercial levels, currently has no marketing and sales organization, has an uncertain market receptiveness to its product candidates, and is uncertain as to whether there will be insurance coverage and reimbursement for its potential products; (x) Silexion may be unable to attract, develop and/or retain its key personnel or additional employees required for its development and future success; (xi) Moringa’s sponsor and other affiliates have potential conflicts of interest in recommending to vote in favor of the Business Combination, including economic incentives to complete a business combination, even if the target business is less favorable to Moringa’s public shareholders; (xii) Moringa’s shareholders who do not redeem their Moringa Class A ordinary shares will have a reduced, minority voting interest after the Business Combination and will exercise less influence over management; (xiii) Moringa does not have a specified maximum redemption limit, which will make it easier for Moringa to consummate the Business Combination even if a substantial majority of Moringa’s public shareholders do not support it; (xiv) The SPAC merger may be a taxable transaction for U.S. federal income tax purposes to U.S. Holders of Moringa Class A ordinary shares and Moringa public warrants; (xv) Silexion may issue additional Pubco ordinary shares or other equity securities without your approval, including shares underlying warrants and note shares, which would dilute your ownership interest and may depress the market price of the Pubco ordinary shares; (xvi) additional factors relating to the business, operations and financial performance of Silexion; and (xvii) other factors detailed under the section entitled “Risk Factors” herein. Should one or more of these risks or uncertainties materialize, or should any of Moringa or Silexion’s assumptions prove incorrect, actual results may vary in material respects from those projected in these forward - looking statements. Moringa, Silexion and Pubco undertake no obligation to update or revise any forward - looking statements, whether as a result of new information, future events or otherwise, except as may be required under applicable securities laws. Before a shareholder grants its proxy or instructs how its votes should be cast or vote on the proposals set forth in this Presentation, it should be aware that the occurrence of the events described in the “Risk Factors” section and elsewhere in the proxy statement/prospectus may adversely affect Moringa, Silexion or Pubco. IMPORTANT ADDITIONAL INFORMATION In connection with the proposed Business Combination, PubCo filed a registration statement on Form S - 4 (Reg No. 333 - 279281) with the SEC that was declared effective on July 16, 2024 and included a proxy statement of Moringa and constituted a prospectus of PubCo. The proxy statement/prospectus contains important information about the proposed Business Combination and related matters. This Presentation does not contain all the information that should be considered concerning the proposed Business Combination and in not intended to form the basis of any investment decision or any other decision in respect of the proposed Business Combination. Moringa stockholders and other interested persons are advised to read the proxy statement/prospectus and other documents filed in connection with the proposed Business Combination because these materials will contain important information about the parties to the business combination agreement, Pubco, Silexion, Moringa and the proposed Business Combination. Stockholders are able to obtain copies of the proxy statement/prospectus, without charge, once available, at the SEC’s website at www.sec.gov . PARTICIPANTS IN SOLICITATION Moringa, Silexion and Pubco and certain of their respective directors, executive officers, other members of management and employees, may, under SEC rules, be deemed to be participants in the solicitation of proxies from the shareholders of Moringa in favor of the approval of the Business Combinaregtion. Shareholders of Moringa and other interested persons may obtain more information regarding the names and interests in the Business Combination of Moringa’s directors and officers in Moringa’s filings with the SEC. Additional information regarding the interests of the persons who may be deemed participants in the solicitation of proxies from Moringa shareholders is available in the proxy statement/prospectus filed by PubCo, available on the SEC’s website at www.sec.gov . INDUSTRY AND MARKET DATA This Presentation has been prepared by Moringa and Silexion and includes market data and other statistical information from third - party sources, including independent industry publications, governmental publications and other published independent sources. Some data is also based on the estimates of Silexion, which are derived from their review of internal sources as well as third - party sources described above. None of Moringa, Silexion or any of their respective representatives or affiliates has independently verified the information and cannot guarantee its accuracy and completeness. TRADEMARKS AND TRADE NAMES This Presentation contains trademarks, service marks, trade names and copyrights of other companies, which are the property of their respective owners. Solely for convenience, trademarks and trade names referred to in this Presentation may appear without the ® or symbols, but such references are not intended to indicate, 2 in any way, that the applicable licensor will not assert, to the fullest extent under applicable law, its rights to these trademarks and trade names. The use or display of third parties’ trademarks, service marks, trade manes or products in this Presentation is not intended to, and does not imply, a relationship with Moringa or Silexion, or an endorsement or sponsorship by or of Moringa or Silexion.

 

 

公司资料 Silexion 的 siRNA 平台科技旨在沉默癌基因并防止突变 KRAS 蛋白质的产生,从而抑制癌细胞生长。使用延长释放的 PLGA 递药系统的 Loder siRNA 完成了第二期试验。结果表明,Loder + chemo 与仅 chemo (SOC) 相比,KRAS G12D/V 突变患者的总生存时间增加了 9.3 个月。优化后的领先候选人 SIL-204 基于 Loder 进入第二/三期临床试验。合并 Moringa Acquisition Corp(一家特别收购公司)并于 2024 年 8 月上市 Nasdaq(“SLXN”)。临床阶段公司正在开发用于 KRAS 基因突变驱动型肿瘤的专有治疗方法。针对 KRAS 的 RNA 干扰平台具有定向传递和有前景的局部晚期胰腺癌的临床数据。业务合并。

 

 

专注于解决KRAS驱动的实体肿瘤和局部癌症问题。CTA=临床试验申请; SOC=标准治疗。项目适应症设定探索前临床研究阶段1阶段2阶段3状态/预期里程碑:LODER siG12D/V + KRAS扩增,具有延长释放PLGA递送系统,治疗局部晚期胰腺癌。联合化疗2期已完成:在KRAS G12D/V突变患者中,LODER相对SOC有9.3个月的改善。继续开发SIL-204。SIL-204(肿瘤内)KRAS G12D/V + KRAS扩增配方和延长释放递送局部晚期胰腺癌。联合化疗2025年:启动毒理学研究。晚2025年:提交以启动2/3期。2期完成了优化的寡核苷酸配方和延长释放输送。

 

 

KRAS癌基因是众多癌症的已验证的靶点,其中CRC代表结直肠癌;LAPC代表局部晚期胰腺癌;NSCLC代表非小细胞肺癌。5 Lee, J.k.等。NPJ Precis Oncol. 2022; 6(1):91。KRAS突变在不同癌症中最常见的类型的患病率PDAC CRC非鳞状NSCLC小肠腺癌附件中,KRAS是人类癌症中最常见的致癌基因驱动者,胃肠癌的KRAS G12D/V突变百分比较高,KRAS突变率92%49%35%53%61%。

 

 

胰腺癌是所有重要癌症中死亡率最高的一种 BRPC =边缘可切除胰腺癌;LAPC =局部晚期胰腺癌。 1. Bray F等。《美国第四大癌症杂志》. 2024;74(3):229-263。 2. Hirshberg胰腺癌研究基金会。胰腺癌事实。https://pancreatic.org/pancreatic-cancer/pancreatic-cancer-facts. 3.国家癌症研究所。癌症Stat事实:胰腺癌。https://seer.cancer.gov/statfacts/html/pancreas.html. 4. Gemenetzis G等。Ann Surg. 2019;270(2):340-347。 5. Kleeff J等。Nat Rev Dis 6 Primers. 2016;2:16022。 诊断时的局部转移:10-20%可切除,30-40%LAPC + BRPC,50-60%转移性或系统性的胰腺癌类型和患病率4,5我们拟定适应症没有有效的治疗选择LAPC 美国今天排名第三的癌症死因,到了2030年将成为第二个主要死因12.8%5年相对生存率(2014-2020年)在美国最差3非切除肝癌人群的中位总体生存期是14-17个月。

 

 

Silexion siRNA技术可以在源头和作用位点治疗KRAS癌症靶点,防止突变的KRAS被产生,而小分子抑制剂则靶向功能性的KRAS蛋白质。在生产阶段沉默癌基因可能是治疗癌症和克服治疗抗性的更有效和更安全的方法。突变的KRAS基因,突变的KRAS mRNA,功能性突变的KRAS蛋白质,转录,翻译,KRAS小分子抑制剂(系统性传递),Silexion siRNA肿瘤内输送,细胞增生,迁移,转化,生存7。

 

 

肿瘤内siRNA治疗比全身治疗更有优势,特别是对于胰腺x有助于克服全身治疗的限制,使其在肿瘤内浓度更高,在原发肿瘤中有更好的暴露性。在肿瘤内给药后,可能会导致体内逃逸受限,从而潜在地降低系统暴露。 EUS内镜超声提供了入侵性微创手术系统内不同部位肿瘤的检测。对于如LAPC这样的实体肿瘤,其以过多纤维组织和低血供为特征,其限制了全身性治疗药物抵达肿瘤以及肿瘤微环境中所需的药物浓度。全身性曝露可能会导致不良反应的增加。全身治疗的限制与肿瘤内治疗的优势

 

 

G12D G12V G12C G12A G12R 多种 KRAS Demographics KRAS 突变体存在于约 G2% 的胰腺癌病例中 1 SIL - 204 突变覆盖了 PDAC 中 > 74% 的 KRAS 突变体 2 KRAS G12C 治疗正在治疗 ~1.5% 的 LAPC = 局部晚期胰腺癌; ROW=世界其他地区。*根据 KRAS 突变体在 92% 的胰腺癌患者中存在,其中 70 - 75% 是 KRAS G12D 和 G12V 突变,而 30 - 35% 的病例为 LAPC,计算了 KRAS G12D/V 突变的 LAPC 数量。1. Lee, J.k. et al. NPJ Precis Oncol. 2022;6(1):91. 2. Yousef, A. et al. NPJ Precis Oncol . 20024;8(1):27. 3. 全球癌症观察数据. 胰腺癌. 2022. https://gco.iarc.who.int/media/globocan/factsheets/cancers/13 - pancreas - fact - sheet.pdf. 4. 国家癌症研究所. 癌症统计事实: 胰腺癌. 2023. 9 https://seer.cancer.gov/statfacts/html/pancreas.html. E.U. U.S. 146,477 3 66,400 4 年度 PC 病例数约为 ~35,000 ~16,000 KRAS - G12D/V 突变的 LAPC 发病率*

 

 

LODER第二阶段试验数据

 

 

Loder二期临床试验已于2023年完成——LODER+ SOC化疗与单独使用SOC化疗进行开放标签两部分概念板块研究,在美国和以色列的不可切除的胰腺癌患者中进行。第1组:LODER+ SOC化疗(n=18),第0天随机化,长期随访,筛选,死亡测定资格,第1次L给药约7天后,第1次化疗,第8周-第1次化疗(n=11)。第2组:SOC化疗+ LO OD ER(n=20),每12周进行一次LODER给药,每12周进行一次化学药物筛查、死亡测定和资格筛查,长期随访,队列1(随机化),队列2(单臂)。关键纳入标准为无转移且不可切除,两个队列所有患者都经过纳入/排除标准的随机化,并未检查KRAS突变状态。终点包括总生存期(OS)、应答率(RR,RECIST v1.1)、安全性和耐受性。

 

 

基线特征和队列信息由于一项临床试验结果表明 FOLFIRINOX 在作为 SoC 化疗方案时胜过 GnP,因此队列 2 的 SoC 化疗方案从 GnP(队列 1 中使用)更改为 FOLFIRINOX。*共确定 31 位患者的 KRAS 突变。在队列 1 中,治疗组中有 12 位患者和对照组中有 10 位患者进行了测试;在队列 1 中,有 9 位患者进行了测试。BRPC 等于边缘可切除胰腺癌;GnP 等于吉西他滨 / 纳布 - 紫杉醇;LAPC 等于局部晚期胰腺癌;SoC 等于标准疗法。队列 2 (n=20)队列 1 (n=2G)单臂随机对照(SoC)设计/武器非切除(BRPC+LAPC)局部晚期 PC(LAPC)的人口62%美国(4个站点),38%以色列(5个站点)国籍42%男性; 58%女性男/女%64.9 69.7 中位年龄(岁) G12D/V *:洛德7/9 G12R *:洛德:2/9 G12D/V *:洛德11/12,对照组5/10 G12R *:洛德:1/12,对照组5/10 KRAS突变2.1 2.8 平均洛德周期370 洛德注射总数(改良后)FOLFIRINOX((m)FFX)吉西他滨/纳布 - 紫杉醇(GnP)SoC 化疗

 

 

Cohort 1组有KRAS G12D/V突变的患者使用Loder Bearing人形机器人-轴承治疗,整体存活时间提高G.3个月,为13个月*与针对向胰腺体癌的最新研究一致的SOC(对照组)OS。 •在具有D或V KRAS突变的受试者亚组中,11名接受Loder治疗的受试者的中位数OS为691天,而5名接受SOC治疗的受试者的中位数OS为409天•未增加统计学意义•虽然所有患者的主要终点未被满足,结果显示在具有KRAS G12D/V突变的患者的治疗组之间存在差异,Loder组表明整体生存优势为9.3个月。TG 1中位数日OS = 13.4个月。* siRNA + SOC化疗中位数= 22.7个月。

 

 

Loder整体耐受性良好•第2阶段PoC临床试验调查员报告Loder治疗被良好耐受;安全事件主要与程序有关——通过内镜(EUS)宫内肿瘤注入缓释siRNA•未报告有导致研究停止或与Loder治疗相关的治疗性不良事件(TEAEs)•没有任何体征参数及体检结果显示有意义的观察结果•独立药物安全监测委员会(DSMB)检查没有安全问题或限制•在亚组分析中,任何血浆样本都检测不到Loder的可测量水平(<BLQ),表明系统水平较低14

 

 

SIL-204 KRAS G12D/V和KRAS扩增的siRNA配方

 

 

利用Loder临床数据进一步提高SIL-204的潜在功效和安全性。*EUS内窥镜是一种标准程序,可用于每3个月进行一次超声器引导活检。SIL-204 LODER KRAS G12D/V+ KRAS扩增KRAS G12D/V siRNA靶向添加亲疏水性引导,以增加siRNA进入细胞内的活性。没有亲疏水性引导,进入肿瘤细胞的途径和时间超过48小时,而不需要1小时。在人类血清中稳定的PLGA微粒悬液,可持续释放3个月。PLGA仓库杆延长释放时间。EUS内窥镜*采用更小更柔软的针头,无需装载装置。EUS内窥镜*采用较大的针头,需要装载装置。在以上改进的2/3期试验中,考虑到趋势+9.3月的化疗联合化疗生存率。

 

 

SIL-204抑制小鼠移植的人类胰腺癌细胞生长,平均肿瘤体积(ml)为:500.0、450.0、400.0、350.0、300.0、250.0、200.0、150.0、100.0、50.0、0.0。未经处理组、PBS组和SIL-204组的肿瘤体积平均值、诱发坏死区域面积平均值和肿瘤中心距离的平均值:17、18、19、20、21、22天。G0和Ut未经处理组、PBS组和SIL-204组的坏死区百分比:0、15、65、120。PBS = 注射PBS缓冲液的对照移植瘤;SC = 皮下;Ut = 未处理的对照。自治治疗开始的第6天增加的平均肿瘤体积为150,SIL-204显著减小了肿瘤体积和重量,并增加了肿瘤的坏死面积。第1天:将Capan-1 (G12V)细胞移植到小鼠体内 (皮下)。第6天:当瘤体被注射到足够大小时,每天对肿瘤注射SIL-204或PBS缓冲液。第10天:切除肿瘤并称重。

 

 

SIL-204在人血清中稳定超过48小时,可考虑在其他适应症中发挥更长时间的效果。siRNA链放置于人血清中测试其稳定性,具有更大的扩散到纤维瘤环境的能力。之前的研究表明siG12D的半衰期为500万。指南链稳定性为100%。0%,10%,20%,30%,40%,50%,60%,70%,80%,90%,100%,在14小时内,siRNA链稳定性为IntacT,LODER和SIL-204分别为0,1,2,4,6,18,24,48%。

 

 

SIL-204在大鼠体内稳定五小时 1. Givlaari (givorisan). 欧洲药品管理局. 2. Alnylam. Givosiran新药申请多学科审查. 3. Lumasiran. FDA审查(美国食品药品监督管理局). 4. Lumasiran. Leqvio, INN- inclisiran(欧洲药品管理局). 5. Inclisiran. Leqvio, INN- inclisiran 19(欧洲药品管理局). 6. Inclisiran欧洲药品管理局评估报告. 7. Vutrisiran. FDA审查摘要. 8. EMA/FDA批准的siRNA药物: ADME研究概述和数据解释. 0 1 2 3 4 5 6 7 8 9 10 SIL-204 Givosiran Lumasiran SIRNA Inclisiran Vutrisiran Hour siRNA大鼠和人体浆液中的半衰期(非直接比较) 大鼠 4-6倍低于人体, 可能提示SIL-204是最稳定的siRNA

 

 

siRNA优化采取了多种措施;对SIL-204进行了研究和筛选,并拥有新的延长释放配方H1 2026 H2 2025 H1 2025 H1 2024 2023;在欧盟国家开展SIL-204用于局部晚期胰腺癌患者的2/3期临床试验;启动SIL-204最终产品的GMP生产并提交欧盟临床试验批件;从德国联邦药品和医疗器械局(BfArM)获得试验设计指导;Loder用于LAPC的临床证明对FDA来说是可批准的终点,实现了SIL-204在LAPC中的开发策略;该列表中的未标记活动将被执行。

 

 

SIL-204在晚期胰腺癌2/3期试验中的研究设计已获德国监管机构对建议的试验设计的积极指导。C化疗组2:SO组1:SIL-204 0.5亿+ SOC 化疗试验结束第1天,2:1随机化DSMb ~15位患者进行为期1个月的随访。如果是胰腺切除后,治疗随访。中期分析~1/3事件,P2→P3转换或停止筛选化疗运行-28天死亡每个患者治疗期24个月或直到死亡或肿瘤过小无法治疗,总生存期为5年的长期扩展试验。2期安全运行-2期扩展为3期共21个。

 

 

世界知名专家科学顾问委员会 Eileen M. O'Reilly, MD 纽约 Memorial Sloan Kettering 医院 Winthrop Rockefeller 医学肿瘤学荣誉主席;David M. Rubenstein 胰腺癌研究中心,医疗事业总监;Hepatopancreatobiliary Section Head,Hana Algul,MD 德国慕尼黑技术大学肿瘤代谢主席;德国慕尼黑 Klinikum rechts der Isar 的全面癌症治疗中心主任和 Mildred-Scheel-教授Milind Javle,MD 德克萨斯大学 MD Anderson 癌症中心,休斯顿,TX,胃肠道医学肿瘤科教授,癌症分部;Philip A. Philip,MD 亨利·福特健康中心,底特律,MI,胃肠道肿瘤学主管,胰腺癌中心联合主任,研究和临床护理一体化的医学总监,亚利桑那大学肿瘤中心 Talia Golan,MD 以色列 Sheba Tel Hashomer 医院,胰腺癌中心主任-SPCC Matthew Katz,MD 德克萨斯大学 MD Anderson 癌症中心,休斯顿,TX,外科肿瘤科主席,外科分部和教授。Andrew M. Lowy,MD 加利福尼亚大学圣迭戈分校,圣迭戈,CA ,外科肿瘤科主席,外科教授 Mark A. Schattner,MD 纽约 Memorial Sloan Kettering 医院,胃肠病学,肝病学和营养服务主席 22

 

 

高度经验的领导团队 伊朗哈达,工商管理硕士 主席兼首席执行官 > 在药品和高科技公司拥有25年的跨国管理和企业经验 米切尔·希尔万,哲学博士,工商管理硕士 首席科学和开发官 > 在生物科技公司中拥有25年的RCD,创新和发现经验 米里特·霍伦斯坦·哈达,注册会计师 首席财务官 > 在公开公司和私人控股公司的高科技和药品行业的高级财务职位上拥有15年的企业金融经验 董事 伊朗·莱文,前莫林加收购公司主席和首席执行官 拥有25年的高科技、以色列相关企业的执行和风险投资/私募股权投资经验 23

 

 

投资亮点 CTA = 临床试验申请; IND = 新药研究申请。 •拥有专有的癌基因siRNA平台的临床阶段公司 •胰腺癌内肿瘤siRNA递送与全身KRAS抑制剂相比具有更好的药物暴露 •Loder与LAPC的2期临床试验显示FDA可批准的总体生存期终点改进了9.3个月 •主导候选药物SIL-204具有增强的siRNA稳定性和更好的延长释放剖面,是一种先进的RNA治疗候选药物 •在肿瘤学中迟期可用的资产,有潜在的监管路径与强大的IP组合 •从德国药品和医疗器械联邦机构(BfArM)获得了2/3期试验的指导 •计划于2025年晚些时候提交欧盟CTA并在2026年开始SIL-204的2/3期试验 •建立了siRNA和递送系统的GMP生产的合作伙伴关系 •具有siRNA和微粒子的强大IP组合,保证独特性到2043年12月并延长