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Molecular Partners 2024年第三季度中期管理声明: 组合物投资组合多方面更新，无线-DARPin候选药MP0712准备进入临床阶段，MP0533阶段1仍在进行中。

Radio-DARPin疗法（RDT）候选药MP0712得到，为抑郁症、焦虑症和其他沉思性障碍提供了有前景的新疗法。在欧洲核医学协会（EANM）大会上提出的数据支持；预计2025年开始进行人体初次试验并获得初步临床数据

与Orano Med签署的战略协议进行了修订和加强：两家公司将共同开发四款RDt产品 212基于Pb的RDt候选者，包括MP0712

MP0533 相位 1 剂量递增研究正在继续进行；将在美国血液学年会（ASH）上进行更新；协议正在修订以改善治疗曝光

CD3交换机-DARPin作用机制证明将在癌症免疫治疗学会年会（海丰国际）上进行展示；Switch-DARPin MP0621的更新将在ASH上进行展示

MP0317相位1生物标志数据在国际癌症免疫治疗大会（CICON）上展示；额外生物标志数据将在SITC上分享

展望：截至2027年资金充足截至2024年9月30日，莫里尔合作伙伴拥有现金和短期定期存款共计1.436亿瑞士法郎，预计2024年营业费用总额为6500-7000万瑞士法郎。

瑞士苏黎世-施利伦和美国马萨诸塞州康科德，2024年10月31日 -- 根据Art. 53 LR的临时公告 – Molecular Partners Molecular Partners（纳斯达克股票代码：MOLN；瑞士股票代码：MOLN）是一家处于临床阶段的生物技术公司，正在开发一类名为DARPin治疗蛋白的定制药物（以下简称“Molecular Partners”或“公司”），今天宣布了2024年第三季度的公司重点和未经审计的财务业绩。

在上个季度，我们继续执行我们的计划，将我们第一个Radio-DARPin项目提交到IND，并进入临床。DLL3仍然是一个备受关注的高度有趣的靶点。我们团队展示了额外的临床前数据，显示MP0712在一个高度相关的肿瘤模型中是安全和有效的，DLL3的表达水平与人类肿瘤中的表达水平相匹配。Patrick Amstutz博士，Molecular Partners首席执行官说。. 此外，我们加强了与合作伙伴Orano Med的关系，确保双方都有机会将两个Radio-DARPin产品推向市场，总共达到四个。最近的资本筹集使我们在2027年之前有额外的财务灵活性，新的专业投资者和支持性现有投资者参与其中。

财务和业务展望

对于2024年全年，在恒定汇率下，该公司重申其在瑞士法郎65-7000万瑞士法郎的总费用指导。其中约700万瑞士法郎将用于股份支付、养老金会计和折旧等非现金有效成本。此指导不包括来自研发合作伙伴的潜在收入。

截至2024年9月30日，公司现金及短期存款金额为14360万瑞士法郎，无债务，预计资金将持续到2027年，不包括来自研发合作伙伴的潜在收入。

2024年10月25日，Molecular Partners宣布在美国进行了一项价值3,642,988美元的美国存托股票（ADS）的承销发行，代表3,642,988股普通股，每股发行价为5.49美元。总收益净额约为2,000万美元。此次发行包括新投资者HBm Healthcare Investments Ltd的参与，该公司是领先的医疗保健投资者，以及多个现有投资者。Leerink Partners和TD Cowen担任本次发行的联席主承销商。LifeSci Capital担任本次发行的首席承销商，Zürcher Kantonalbank（ZKB）担任结算代理。Molecular Partners目前打算将本次发行的净收益与现有的现金及现金等价物一起，用于发展和扩展其放射性药物管线和平台（Radio-DARPin Therapeutics），以及用于营运资本和其他一般公司用途。在发行后，公司的现金及短期定期存款（proforma）金额为15800万瑞士法郎，发行股数为40,363,095股。

研发亮点

MP0712和Radio-DARPin疗法（RDT）：准备在2025年提交IND并进行临床试验入境

Molecular Partners利用DARPins的固有特性，如小尺寸、高亲和力和特异性，将Radio-DARPins作为理想的向量候选体用于放射性药物疗法，并创建了适用于广泛肿瘤靶向的Radio-DARPin疗法（RDT）平台。从历史上看，基于小蛋白的向量存在肾脏蓄积和毒性、以及肿瘤摄取不足等挑战。Molecular Partners的RDt平台通过其半衰期延长技术和表面工程方法解决了这些限制，同时保留了小蛋白格式的优点。

MP0712是 212基于市净率的 Radi-DArPin疗法（RDT）候选药物，靶向肿瘤相关蛋白δ类配体3（DLL3）。MP0712正在与Orano Med共同开发，Orano Med是一家临床先导性公司，使用铅同位素Pb进行靶向α放射性治疗。 212铅。分子

合作伙伴和Orano Med预计在2025年进行首次人体研究，待获得监管机构批准。MP0712的初步临床数据也预计在2025年出现。

2024年10月，Molecular Partners在EANm大会上展示了新的数据。体内MP0712对DLL3具有高亲和力和特异性，并具有良好的安全性。DLL3在小基站-5g肺癌患者的肿瘤中表达丰富（在超过85%的肿瘤中表达），并且在其他侵袭性神经内分泌肿瘤中也是如此，而在健康组织中的表达较低。在多个模型的生物分布研究中，MP0712表现出较大的肿瘤对肾脏（T:K）比例（>2），并在小鼠中表现出强大且剂量依赖的效果，在那些携带临床相关DLL3表达水平和临床相关剂量的肿瘤的小基站-5g小鼠身上。

2024年10月22日，分子伙伴和Orano Med签署了一份修订并加强的协议，共同开发 212基于市净率的 Radio-DARPin 治疗方案。这次修订是基于2024年1月签署的原始协议。根据修订后的协议，两家公司将共同开发四个 Radio-DARPin 项目；每家公司将有权商业化两个项目（之前为每个项目一家）。分子伙伴将持有第二个被提名的 Radio-DARPin 候选药物的商业化权利，除了对第一个项目 MP0712 的权利。

除了上述更新外，Molecular Partners继续通过与诺华的合作推进其RDt组合方案，并正在评估RDt项目的额外目标。预计将在2025年上半年分享更广泛的RDt组合方案更新。

MP0533（多特异性T细胞激动剂）

MP0533，一种新型的四特异性T细胞结合DARPin，目前正在进行一项针对复发/难治性急性髓样白血病（r/r AML）和髓增生异常综合征/AML（MDS/AML）患者的1/2a期临床试验中进行评估（ClinicalTrials.gov: NCT05673057）。该试验目前正在招募第8队患者。MP0533的作用方式旨在选择性地杀死表达CD33、CD123和CD70三种细胞表面抗原中任意组合的AML细胞（幼稚细胞、白血病祖细胞和干细胞），同时保护健康细胞，健康细胞倾向于只表达其中一种或一种也不表达这些靶标。通过CD3介导的T细胞结合实现对恶性细胞的免疫激活。

As shared in August 2024, MP0533 showed an acceptable tolerability profile with the majority of adverse events reported being infusion-related reactions and cytokine release syndrome. Based on this observed tolerability profile and initial antitumor activity data, and following discussion with treating physicians and key opinion leaders, Molecular Partners is amending the protocol to further increase dosing and improve the exposure profile of MP0533.

Molecular Partners plans to present the next clinical update of the program at the American Society of Hematology (ASH) Annual Meeting in San Diego on December 7–10, 2024, and data following the protocol amendment are expected in 2025.

Switch-DARPin Platform (next-gen immune cell engagers)

The Switch-DARPin platform provides a logic-gated “on/off” function (the “Switch”) to multi-specific DARPin candidates leading to target activation only in the presence of defined antigens. The objective is conditional activation of a targeted immune response.

MP0621 is a Switch-DARPin candidate designed to induce killing of hematopoietic stem cells as a next-generation conditioning regimen for HSCT. The in vivo proof-of-mechanism data, as presented at EHA 2024, demonstrate that MP0621 could be an efficient next-generation conditioning regimen for autologous HSCT. At present, the non-human primate data do not indicate that MP0621 would serve as a treatment for AML. As Molecular Partners’ portfolio strategy prioritizes therapeutic candidates for oncology, MP0621 is being evaluated for partnering. The Company plans to present a preclinical update on MP0621 at ASH 2024.

Proof-of-concept preclinical data on an additional Switch-DARPin candidate, namely a CD3 Switch-DARPin T cell engager for solid tumors, will be presented at SITC 2024 on November 9, 2024. The CD3 Switch-DARPin targets the highly validated immunostimulatory protein CD3 to deliver a T cell-engager (TCE) mechanism with enhanced function via engagement of additional receptors on the surface of T cells. TCEs are a powerful class of immuno-oncology therapies but have faced a range of challenges such as toxicity, poor T cell fitness and immune suppression, particularly in solid tumors. By employing a multi-specific Switch approach, Molecular Partners aims to broaden the therapeutic space for T cell engagers.

MP0317 (localized agonist)

MP0317 is a CD40 agonist designed to activate immune cells specifically within the tumor microenvironment (TME) by anchoring to fibroblast activation protein (FAP) which is expressed in high amounts around tumors. This tumor-localized approach has the potential to deliver greater efficacy with fewer side effects compared to systemic CD40-targeting therapies.

In September 2024, the Company presented details of the transcriptomic analysis from its completed Phase 1 study at CICON 2024. The analysis of patient biopsies pre- and post-treatment with MP0317 showed that this molecule remodels the tumor microenvironment by inducing infiltration of B, plasma, dendritic, and T follicular helper cells.

Molecular Partners plans to share a comprehensive biomarker analysis of its completed Phase 1 study at SITC on November 9, 2024.

The positive Phase 1 data support further clinical evaluation of MP0317 in combination with complementary anticancer therapies and demonstrated the ability of the DARPin design to deliver on a targeted, tumor-localized CD40 activation mechanism. Molecular Partners is in discussion with leading academic centers regarding potential investigator-initiated combination trials.

Expected Financial Calendar


March 6, 2025			Corporate Highlights Q4 2024 and Key Financials for Full Year 2024
April 16, 2025			Annual General Meeting
May 15, 2025			Interim Management Statement Q1 2025

The latest timing of the above events can be viewed on the investor section of the corporate website.

About DARPin Therapeutics
DARPin (Designed Ankyrin Repeat Protein) therapeutics are a new class of custom-built protein drugs based on natural binding proteins that open new dimensions of multi-functionality and multi-target specificity in drug design. The flexible architecture, intrinsic potential for high affinity and specificity, small size and high stability of DARPins offer benefits to drug design over other currently available protein-based therapeutics. DARPin candidates can be radically simple, with a single DARPin unit acting as the delivery vector to a specific target; or multispecific, with the possibility of engaging more than five targets, and combining multiple and conditional functionalities in a unique DARPin drug candidate. The DARPin platform is designed to be a rapid and cost-effective drug discovery engine, producing drug candidates with optimized properties and high production yields. DARPin therapeutics have been clinically validated across several therapeutic areas and developed through to the registrational stage.

About Molecular Partners

Molecular Partners AG is a clinical-stage biotech company pioneering the design and development of DARPin therapeutics for medical challenges other drug modalities cannot readily address. The Company has programs in various stages of pre-clinical and clinical development, with oncology as its main focus. Molecular Partners leverages the advantages of DARPins to provide unique solutions to patients through its proprietary programs as well as through partnerships with leading pharmaceutical companies. Molecular Partners was founded in 2004 and has offices in both Zurich, Switzerland and Concord, MA, USA. For more information, visit www.molecularpartners.com and find us on LinkedIn and Twitter/X @MolecularPrtnrs

For further details, please contact:
Seth Lewis, SVP Investor Relations & Strategy
Concord, Massachusetts, U.S.
seth.lewis@molecularpartners.com
Tel: +1 781 420 2361

Laura Jeanbart, PhD, Head of Portfolio Management & Communications
Zurich-Schlieren, Switzerland
laura.jeanbart@molecularpartners.com
Tel: +41 44 575 19 35

Cautionary Note Regarding Forward-Looking Statements

Any statements contained in this press release that do not describe historical facts may constitute forward-looking statements as that term is defined in the Private Securities Litigation Reform Act of 1995, as amended, including without limitation: implied and express statements regarding the clinical development of Molecular Partners’ current or future product candidates; expectations regarding timing for reporting data from ongoing clinical trials or the initiation of future clinical trials; the potential therapeutic and clinical benefits of Molecular Partners’ product candidates and its RDT and Switch-DARPin platforms; the selection and development of future programs; Molecular Partners’ collaboration with Orano Med including the benefits and results that may be achieved through the collaboration; and Molecular Partners’ expected business and financial outlook, including anticipated expenses and cash utilization for 2024 and its expectation of its current cash runway and the expected use of proceeds from the underwritten offering. These statements may be identified by words such as “aim”, “expect”, “guidance”, “intend”, “outlook”, “plan”, “potential”, “will” and similar expressions, and are based on Molecular Partners’ current beliefs and expectations. These statements involve risks and uncertainties that could cause actual results to differ materially from those reflected in such statements. Some of the key factors that could cause actual results to differ from Molecular Partners’ expectations include its plans to develop and potentially commercialize its product candidates; Molecular Partners’ reliance on third party partners and collaborators over which it may not always have full control; Molecular Partners’ ongoing and planned clinical trials and preclinical studies for its product candidates, including the timing of such trials and studies; the risk that the results of preclinical studies and clinical trials may not be predictive of future results in connection with future clinical trials; the timing of and Molecular Partners’ ability to obtain and maintain regulatory approvals for its product candidates; the extent of clinical trials potentially required for Molecular Partners’ product candidates; the clinical utility and ability to achieve market acceptance of Molecular Partners’ product candidates; the potential that Molecular Partners’ product candidates may exhibit serious adverse, undesirable or unacceptable side effects; the impact of any health pandemic, macroeconomic factors and other global events on Molecular Partners’ preclinical studies, clinical trials or operations, or the operations of third parties on which it relies; Molecular Partners’ plans and development of any new indications for its product candidates; Molecular Partners’ commercialization, marketing and manufacturing capabilities and strategy; Molecular Partners’ intellectual property position; Molecular Partners’ ability to identify and in-license additional product candidates; unanticipated factors in addition to the foregoing that may impact Molecular Partners’ financial and business projections and guidance; and other risks and uncertainties set forth in Molecular Partners’ Annual Report on Form 20-F for the year ended December 31, 2023 and other filings Molecular Partners makes with the SEC from time to time. These documents are available on the Investors page of Molecular Partners’ website at www.molecularpartners.com. In addition, this press release contains information relating to interim data as of the relevant data cutoff date, results of which may differ from topline results that may be obtained in the future. Any forward-looking statements speak only as of the date of this press release and are based on information available to Molecular Partners as of the date of this release, and Molecular Partners assumes no obligation to, and does not intend to, update any forward-looking statements, whether as a result of new information, future events or otherwise.