Molecular Partners Stock

Molecular Partners AG (Molecular Partners) operates as a clinical-stage biopharmaceutical company.

The company is pioneering DARPin candidates to treat serious diseases, with a current focus on oncology and virology. The company’s DARPin platform, which is built using designed ankyrin repeat proteins, or DARPins, allows the company to generate candidates with multiple mechanisms of action, or MOAs, to address complex biological problems.

DARPins are a novel class of drugs with broad therapeutic applications that may overcome many of the limitations of conventional protein and antibody-based therapeutics. The company’s DARPin candidates have been extensively tested in preclinical studies and clinical trials, including in approximately 2,500 patients, and have been observed to be highly active and generally well-tolerated.

Leveraging the company’s DARPin platform, the company has designed product candidates with multiple MOAs that have the potential to offer patients therapeutic options with higher efficacy and fewer adverse events as compared to the current standard of care. Among these multiple MOAs, DARPin product candidates have been designed to block growth factors, localize activity, conditionally activate, neutralize viruses, adjust half-life as needed, and initiate cell death. The company applies these features across its portfolio to elicit a specific therapeutic response.

Pipeline

Molecular Partners’ pipeline includes two key areas: oncology (blue) and virology (green). In addition, the company is reviewing opportunities in ophthalmology (gray). While the company’s DARPin candidates have distinct therapeutic features and particular targets, each DARPin therapeutic modality can be utilized across multiple programs.

The company has research collaboration agreements with Novartis, as well as other third party collaborators.

Strategy

The key aspects of the company’s strategy include the following:

Rapidly advance the company’s tri-specific T-cell engaging DARPin, MP0533, for patients with AML and high-risk MDS. Presently in a Phase 1 clinical trial, the company plans to establish the safety and tolerability profile of the program, and will aim to identify a therapeutic dose level for additional clinical evaluation. Initial preliminary clinical data is anticipated to be reported by the end of 2023.

Unlock novel biological solutions and expand therapeutic applications of clinically validated DARPin approaches. As the inventors of the DARPin class of drugs, the company is the world leaders in DARPin engineering and research. With this expertise, the company has developed a strategy of unlocking various technical hurdles which may limit other discovery platforms, and then expanding the company’s clinical product candidates based upon each technological solution. Examples of this include the conditional activation of the company’s oncology programs MP0317 and MP0310, the avidity driven mechanism of MP0533, and multi-specificity of the company’s COVID-19 antiviral ensovibep.

Maintain a robust discovery program leveraging the company’s proprietary DARPin libraries and novel DARPin-based biological solutions. DARPins are designed to be added to new product candidates in a modular fashion to address novel disease biology. This process enables the company to construct and screen multi-specific DARPin molecules for new disease areas and to quickly identify and progress differentiated candidates for the company’s oncology and virology programs. In pursuit of a sustainable and diversified portfolio, the company plans to develop potentially innovative and transformational constructs directed against the most promising targets in the company’s areas of focus.

Continue a strategic approach to in-house versus partnered development. To unlock and expand the full potential of the company’s DARPin platform, the company intends to independently develop and commercialize product candidates in the company’s core focus areas, where the company has an established clinical and regulatory approval pathway and the resources to commercialize successfully. To complement this approach, the company also plans to collaborate with biopharmaceutical companies on product candidates that have promising utility in target areas or patient populations requiring greater global development capabilities or those outside of the company’s strategic focus.

This strategy has allowed the company to pursue major therapeutic innovations for the DARPin platform, often in parallel, across the company’s oncology and virology focus areas. To this end, the company continues to support its partners across the company’s portfolio as the company advances its Radio DARPin-Therapy Platform, both independently and in collaboration with Novartis; and the company’s research collaboration with the University of Bern for MP0533.

The company will also seek to collaborate with companies developing complementary technology to its platform when the company sees the strategic rationale to combine the company’s industry-leading DARPin capabilities with other modalities.

DARPin Platform

The foundational technology the company uses in its DARPin platform to generate the company’s product candidates was initially licensed to the company by the University of Zurich. Leveraging the company’s DARPin platform, the company has designed product candidates with MOAs that have the potential to offer patients therapeutic options with higher efficacy and fewer adverse events compared to the current standard of care. Among these multiple MOAs, DARPin product candidates have been designed to block growth factors, localize activity, conditionally activate, neutralize viruses, adjust half-life as needed and initiate cell death. The company applies these features across its portfolio to elicit a specific therapeutic response.

The company’s DARPin platform has the potential to yield novel product candidates with broad therapeutic application given their ability to overcome many of the limitations of antibody and other conventional protein-based therapeutics.

The company’s accumulated preclinical and clinical experience of developing and testing DARPin candidates has allowed the company to establish an intellectual property portfolio that, as of December 31, 2022, included over 180 granted patents and over 190 additional pending U.S. and foreign patent applications across more than 30 patent families, covering both core and derivative aspects of the company’s DARPin platform.

Oncology Programs

Localized Immune Agonists: MP0317 and MP0533 Product Candidates

In the company’s oncology program the company is currently developing and assessing two product candidates with localized immune agonists:

MP0317, which allows for tumor-restricted immune-cell CD40 activation for the treatment of FAP positive cancers; and

MP0533, which targets CD3, CD70, CD123 and CD 33 for the treatment of AML.

Development of the company’s MP0317 and MP0533 product candidates has leveraged the learnings from the company’s two first-generation product candidates in the company’s oncology program, MP0250, MP0274 and MP0310. Those candidates have shown efficacy and tolerability in preclinical and clinical studies in patient populations who were resistant and /or refractory to previous standard of care treatments.

However, MP0317 and MP0533 both utilize novel mechanisms of action, which may result in greater research and development expenses, regulatory issues that could delay or prevent approval, or the discovery of unknown or unanticipated adverse effects.

MP0317: DARPin Product Candidate Targeting FAP x CD40

Designed to activate CD40 only in FAP-high tumor tissue.

Localized activation by FAP targeting underpins the therapeutic benefits while expanding the range of immune cell activation.

Designed to reinforce the effect of other immune stimulating therapies.

Shown in vitro to repolarize M2 macrophages and revert T-cell suppression.

Positive interim Phase 1 clinical trial data presented at SITC in the fourth quarter of 2022.

The tumor-localized immune agonist MP0317 is one of the company’s product candidates being developed in its oncology pipeline. MP0317 comprises a localizer to FAP and immune stimulator binding to CD40. FAP is found in the tumor stroma in high density and its binding is intended to create a cluster of CD40 on immune cells enabling immune activation. MP0317 is designed to simultaneously engage FAP and CD40 to create tightly bound clusters around tumors, which are necessary to induce CD40-mediated local immune activation. CD40 plays a critical role in antigen presentation and the monocyte maturation process, and therefore, indirectly, T-cell activation. One of the main functions of CD40 signaling is to enhance antigen-presentation to T-cells by activating dendritic cells, or DCs. CD40 engagement on the surface of DCs promotes cytokine and chemokine production, induces expression of costimulatory molecules, and facilitates the cross-presentation of antigens. This step increases the interaction of DCs with T-cells by upregulating surface proteins, such as CD54 and CD86, thereby activating the surface proteins.

Agonist anti-CD40 antibody treatments have been associated with mild to moderate toxicity in the clinic, which is related to on-target but off tumor effects causing CRS and liver toxicity.

Aiming to avoid CD40-related toxicity, the company developed MP0317 to work as a locally activated CD40 engager, designed to only activate the immune system when both FAP and CD40 are simultaneously engaged. The company expects this localizing mechanism to reduce the likelihood of extra-tumoral systemic side effects and allow an increase of the therapeutic index.

In April 2021, the company presented new data at the 2021 AACR virtual annual meeting, showing further supportive evidence of MP0317’s unique therapeutic potential in an ex vivo model system. The results demonstrated an MP0317-dependent repolarization of macrophage phenotypes and reveal a release of T-cells from macrophage-mediated suppression. The preclinical study has additionally demonstrated FAP-dependent activation of CD40-expressing B-cell and myeloid cell populations in dissociated human tumors.

In November 2021, the company announced the first patient had been dosed in the company’s Phase 1 clinical trial evaluating the safety and tolerability of MP0317.

The open-label dose escalation study is designed to assess the safety and tolerability, as well as pharmacokinetics and pharmacodynamics of MP0317 as a monotherapy in patients with solid tumors known to express fibroblast activation protein (FAP) and CD40. A total of up to 30 patients are expected to be enrolled across six dosing cohorts and up to 15 patients will be enrolled in a dose expansion cohort. In addition to evaluating monotherapy dynamics, the study will gather a wide variety of biomarker data to support the establishment of combination therapies with MP0317 in specific indications.

The company’s team presented positive interim results from the ongoing Phase 1 trial of for the treatment of solid tumors at the 37th Society for Immunotherapy of Cancer (SITC) Annual Meeting in November 2022. These data demonstrated the first clinical observation of tumor localized CD40 activation provided by MP0317, which was also observed to be safe and well-tolerated. There was no dose-limiting CD40-related systemic toxicities observed to-date as well as no signs of inflammatory cytokine release. The company is continuing this ongoing dose escalation Phase 1 clinical trial, with patient recruitment in the dose escalation portion of the trial expected to be completed in the first half of 2023. The company’s team expects the final data set to inform the therapeutic dose for evaluation in a potential Phase 1b/2 trial in combination with relevant cancer treatment.

MP0533: DARPin Product Candidate Targeting CD3, CD70, CD123 and CD33 for the Treatment of AML

MP0533 is another DARPin product candidate designed to engage CD3 on T-cells and target AML cells by the tumor-associated antigens, or TAAs, CD70, CD123 and CD33.

The unmet medical need in AML remains high. Despite the achievement of remission for a majority of patients, up to 70% of adults and 30% of children will not survive beyond five years after initial clinical response due to relapsing disease. Further, the treatment of relapsed/refractory AML, or r/r AML, is therapeutically challenging due to high relapse rates with current standard of care treatments and the aggressive nature of the disease. A variety of highly potent mono-targeting TCE and CAR-T therapies have entered clinical development, but those therapies are often accompanied by dose limiting toxicities, such as cytokine release syndrome, or CRS, and myelotoxicities, preventing dose escalation to induce robust anti-tumor efficacy. More selective therapies addressing the growing number of subclasses and rationally designed target combinations are needed to allow for extended dose escalation with a more acceptable safety profile and to achieve more durable responses.

In AML, leukemic stem cells, or LSCs, produce all the leukemic cells in the patient and therefore a lasting cure for this disease is dependent on eradication of these cells. However, LSCs are relatively resistant to standard therapies. For example, these cells are less sensitive to killing by daunorubicin and cytarabine, two commonly used chemotherapeutic agents. This is partially due to increased expression by LSCs of multidrug resistance genes, and also to their quiescent state, which reduces the effects of cytotoxic agents that target rapidly replicating cells. It is therefore essential to primarily target LSCs to achieve durable disease control.

Some cancer antigens are also present on many healthy cells, but at a lower concentration, and as such it is difficult to select any single target to sufficiently differentiate between cancer cells and healthy tissue. To overcome this limitation and increase specificity, the company leveraged its unique DARPin platform to generate a multi-specific T-cell engager (TCE) DARPin molecule, targeting CD33, CD70 and CD123, by a fine-tuned and tailored avidity-driven affinity to these TAAs, in conjunction with the company’s CD3-binding DARPin molecule.

In avidity-driven selectivity, the presence of two or more binding targets on the cell, and the molecular interaction with these targets increases the effective concentration of the binder and the resulting binding strength. This dependency of binding strength on the presence of more than one cancer antigen conveys a far superior selectivity to these multi-specific binders. This approach is a concept that is well known in the scientific community but has so far been limited by the availability of an optimal therapeutic platform to address the associated technical challenges. In order to find the right target combination, the optimal affinity to increase tumor specificity via avidity, as well as the best molecular architecture, the company took advantage of the company’s unique modular DARPin platform and screened thousands of combinations of multi-specific DARPin molecules, binding simultaneously to the three different TAAs — CD33, CD70 and CD123. Furthermore, the company combined its three DARPin binders with its CD3-binding TCE DARPin into the company’s candidate, MP0533.

The company’s approach allows for the design of multi-specific TCEs which are designed to simultaneously target CD33, CD70 and CD123, three well-known AML antigens that are co-expressed on approximately 50% of AML cells and of which at least two are expressed on approximately 70% of AML cells. To further optimize the company’s molecules, the company has devised a concentration dependent MOA utilizing moderate affinity binders rather than high affinity ones. When such a DARPin encounters a cell expressing only one antigen, there should only be a transient interaction and the DARPin should quickly disengage the target with limited cytotoxic effect. However, when there are two or three targets, the mechanism of aviditydriven selectivity is activated.

In preclinical tests against AML cells, the company observed MP0533 delivered highly potent and specific activity and the potential for a reduced effect on healthy normal cells. As well as its increased selectivity, MP0533's ability to target three TAAs simultaneously gives it additional potential to counteract target escape mechanisms expected due to tumor heterogeneity. In addition, this mechanism is designed to capture a larger population of AML patients due to its ability to engage with any two of these targets simultaneously, while maintaining specificity.

In preclinical studies, MP0533's targeting of three different AML antigens with potentially optimized affinity and geometry demonstrated substantial avidity gain and an increased selectivity window. The avidity gain resulted in strongly enhanced in vitro potency as shown by activation of both CD8+ and CD4+ T-cells and subsequent killing of AML tumor cells. Bioactivity was in the range of established TCE benchmark formats, such as BiTE and DART and compared to reference constructs where TAA-specific DARPin binders were replaced by non-binding-DARPin modules. The company generated selectivity data by comparing its multi-specific DARPin constructs on MOLM-13 AML cell lines where the respective TAAs have been knocked out individually or in combination. The tumor specificity, and resulting potential for a better safety profile, of the company’s DARPin construct has been confirmed in an ex vivo blood assay testing potential CRS liabilities. In this assay, the company’s multi-specific DARPin construct induced profoundly less cytokine release as compared to benchmark molecules indicating an improved therapeutic window.

In December 2021, the company announced a research collaboration with the University of Bern, to advance the development of MP0533, into the clinic. The collaboration aims to leverage the company’s DARPin technology and the University of Bern group’s expertise in AML, and specifically in LSCs.

In an oral presentation at the 64th American Society of Hematology (ASH) Annual Meeting in December 2022, the company presented preclinical results showing MP0533, can induce preferential killing of cells expressing two or three tumor-associated antigens, or TAAs compared to cells expressing a single TAA.

MP0533 was demonstrated to activate T cells and destroy AML cells in samples from newly diagnosed and previously treated AML patients with different TAA expressions. Humanized mouse models showed MP0533’s ability to activate intra-tumoral T-cells and control tumor growth. The research also showed that MP0533 was able to directly target and kill LSCs, while sparing a variety of healthy cells, including hematopoietic stem cells. This targeted feature of MP0533 was further supported by several other parameters, including a lower level of cytokine release relative to benchmark mono-targeted T-cell engagers, both in vitro in a whole blood assay and in vivo in the humanized mouse AML models.

In January 2023, the first patient was dosed in the company’s Phase 1 clinical trial of MP0533. Interim preliminary clinical results from this trial are expected to be reported by the fourth quarter of 2023.

MP0310: DARPin Molecule Targeting 4-1BB x FAP

MP0310 is a dual-targeted compound, targeting both FAP and 4-1BB, that has the potential to activate T-cells and other immune cells, specifically in the tumor microenvironment, aiming to avoid systemic side effects associated with 4-1BB activation.

In April 2022, Amgen, the company’s collaboration partner for MP0310 (AMG 506), informed the company of its decision to return global rights of MP0310 to the company following a strategic pipeline review.

Radio DARPin Therapy Platform

The company is developing DARPin-based radiotherapeutic candidates, both proprietary, as well as in collaboration with Novartis. In 2022, the company progressed its Radio DARPin Therapy (RDT) Platform, selecting tumor-associated protein Delta-like ligand 3, or DLL3, as the first target of the company’s in-house RDT program. Expression of DLL3 is low in healthy tissue but significantly increased in certain tumor types, providing an opportunity for selective targeting through the high-affinity and specificity offered by DARPins.

In December 2021, the company announced a new collaboration with Novartis in the form of a license and collaboration agreement to develop, manufacture and commercialize DARPin-based radiotherapeutics. By harnessing the power of radioactive atoms, or radionuclides, and applying it to cancers through targeted radioligand therapy, DARPin-based radiotherapeutics have the potential to selectively deliver molecularly targeted radiation to tumor cells anywhere in the body, while sparing healthy tissue. DARPins have significant potential to enable robust, tumor-specific delivery of radionuclides owing to their small size in combination with high specificity and affinity.

The collaboration will combine the company’s industry-leading ability to rapidly generate high-affinity DARPins and the radioligand therapies, or RLT, capabilities and expertise of Novartis. Under the terms of the agreement, the company will collaborate with Novartis to discover DARPin-based radiotherapeutic candidates that target specific tumor associated antigens.

Novartis will be responsible for all clinical development and commercialization activities.

DARPins' attributes along with their small size and platform optimizations to minimize kidney accumulation make DARPins ideal delivery vectors for therapeutic radionuclides to efficiently target cancer cells with minimal systemic side effects.

The company plans to present its research of Radio DARPin Therapy candidates and their potential differentiation as tumor targeting moieties in scientific conferences in 2023.

Virology Program

In 2020 the company launched the first product candidate from the company’s virology program, ensovibep (MP0420), which targets the SARS-CoV-2 virus. The company’s rapid candidate design and assessment process allowed the company to quickly substantiate the potential of an antiviral DARPin approach and its differentiation compared to other therapeutic modalities. Based on the potential of DARPin therapeutics as antivirals, the company is actively assessing other global viral threats with high unmet need as potential targets for new product candidates in the company’s virology program.

COVID-19 Product Candidate: Ensovibep (MP0420)

Ensovibep is a first-in-class, multi-specific DARPin therapeutic candidate, designed to bind three different epitopes on the receptor-binding domain, or RBD, of the SARS-CoV-2 spike protein simultaneously.

In January 2022, Novartis exercised its option to in-license ensovibep and is now solely responsible for further development, manufacturing, and commercialization activities.

The primary analysis from Phase 2 of the EMPATHY clinical trial was presented at the 2022 European Congress of Clinical Microbiology and Infectious Diseases (ECCMID) in April 2022. Key preclinical data documenting the unique design and mechanism of action of ensovibep were published in Nature Biotechnology in July 2022.

Ensovibep was submitted in February 2022 for Emergency Use Authorization or EUA following the successful global EMPATHY clinical study. Later, the U.S. Food and Drug Administration, or FDA asked that Phase 3 data be provided for their review.

The clinical development of ensovibep was halted in 2022 due to a lack of neutralization activity against omicron subvariants.

Other Programs

Abicipar

Abicipar is a DARPin therapeutic candidate designed to inhibit vascular endothelial growth factor (VEGF). It is at the registrational stage as an investigational candidate for the treatment of neovascular (wet) age-related macular degeneration (nAMD). Abicipar is also an investigational candidate for diabetic macular edema, or DME. Abicipar is designed to remain in the eye longer than current treatments and consequently offers the potential for less frequent dosing.

Molecular Partners regained global development and commercial rights to abicipar for the treatment of neovascular age-related macular degeneration (nAMD) and Diabetic Macular Edema (DME). The company has reported two positive Phase 3 clinical trials of abicipar, CEDAR and SEQUOIA, which supported the non-inferior efficacy of its quarterly dosing regimen with 50 % fewer injections than ranibizumab.

The company is evaluating potential business development opportunities for abicipar.

Intellectual Property

The company maintains three categories of patent protection for, respectively, the company’s DARPin technology platform, key single-binding domain DARPin proteins binding to specific targets and the company’s DARPin product candidates. The first category of protection covers the company’s DARPin technology platform:

In an effort to stay a leader in the field of repeat protein technology, the company has continued to work on improving the basic ankyrin repeat protein technology and have filed patent applications covering these improvements. Furthermore, the company has enhanced its efforts to innovate in the ankyrin repeat protein field, including by developing new molecular designs, by generating ankyrin repeat proteins with novel modes of action, and by applying the ankyrin repeat protein technology to new disease areas and new target classes. The company has translated this enhanced innovation into the generation of new intellectual property and has expanded the company’s patent portfolio in the last couple of years. Taken together, the company has made progress in protecting improvements of the DARPin base technology and innovative new aspects and applications of the DARPin technology in newly filed patent applications. However, the company can provide no assurances that any such patent applications will be issued as patents.

One example of a patent family that the company owns in this category is based on international patent application WO 2012/069655, relating to DARPin binding proteins comprising certain improved N-terminal capping modules. As of December 31, 2022, the company owned three issued U.S. patents, nine issued foreign patents (i.e. patents granted in jurisdictions other than the U.S.) and one pending foreign patent application in this family. Any issued patents in this family are expected to expire in 2031. The disclosed improvement of the DARPin platform is included in the company’s DARPin product candidates MP0250, MP0274, MP0310, MP0317, MP0420 (ensovibep), MP0423 and MP0533.

Other patent applications falling in this category have been filed and are being prosecuted.

A second category of protection covers the company’s key single-binding domain DARPin proteins binding to specific targets. These single domain DARPin binding proteins can be used in multiple DARPin product candidates. The company’s patent applications and corresponding patents directed to key single domain DARPin binding proteins include:

One example of a patent family that the company owns in this category is based on international patent application WO 2010/060748, relating to single domain DARPin binding proteins with specificity for vascular endothelial growth factor A, or VEGF-A. As of December 31, 2022, the company owned one issued U.S. patent and 31 issued foreign patents in this family. Any issued patents in this family are expected to expire in 2029, with the exception of one U.S. patent that received patent term adjustment and is expected to expire in 2031. VEGF-specific DARPin binding proteins are used in the company’s DARPin product candidates abicipar and MP0250.

Another example of a patent family in this category is based on international patent application WO 2014/191574, relating to single domain DARPin binding proteins with specificity for hepatocyte growth factor, or HGF. As of December 31, 2022, the company owned one issued U.S. patent and seven issued foreign patents in this family. Any issued patents in this patent family are expected to expire in 2034. An HGF-specific DARPin binding protein is used in the company’s DARPin product candidate MP0250.

Another example of a patent family in this category is based on international patent application WO 2012/069654, relating to single domain DARPin binding proteins with specificity for human serum albumin, or HSA. As of December 31, 2022, the company owned two issued U.S. patents, 21 issued foreign patents and seven pending foreign patent applications in this family. Any issued patents in this family are expected to expire in 2031. HSA-specific DARPin binding proteins are used in the company’s DARPin product candidates MP0250, MP0274, MP0310, MP0317, MP0420 (ensovibep), MP0423 and MP0533.

Another example of a patent family in this category is based on international patent application WO 2014/083208, relating to DARPin product candidates comprising two different DARPin binding proteins that bind to specific, but distinct, sites on HER2. As of December 31, 2022, the company owned one issued U.S. patent, 13 issued foreign patents and three pending foreign patent applications in this family. Any issued patents in this patent family are expected to expire in 2033. Such a DARPin molecule comprising two different HER2-specific DARPin binding proteins is used in the company’s product candidate MP0274.

Another example of a patent family in this category is based on international patent application WO 2020/245173, relating to single domain DARPin binding proteins with specificity for fibroblast activation protein, or FAP. As of December 31, 2022, the company owned one pending U.S. patent application and 12 pending foreign patent applications in this family. Any issued patents in this family are expected to expire in 2040. FAP-specific DARPin binding proteins are used in the company’s DARPin product candidates MP0310 and MP0317.

Another example of a patent family in this category is based on international patent application WO 2020/245175, relating to single domain DARPin binding proteins with specificity for 4-1BB. As of December 31, 2022, the company owned one pending U.S. patent application and six pending foreign patent applications in this family. Any issued patents in this family are expected to expire in 2040. 4-1BB-specific DARPin binding proteins are used in the company’s DARPin product candidate MP0310.

Another example of a patent family in this category is based on international patent application WO 2020/245171, relating to improved single domain DARPin binding proteins with specificity for HSA. As of December 31, 2022, the company owned one pending U.S. patent application and 13 pending foreign patent applications in this family. Any issued patents in this family are expected to expire in 2040. Disclosed HSA-specific DARPin binding proteins are used in the company’s DARPin product candidates MP0310, MP0317 and MP0533.

Other patent applications falling in this category have been filed and are being prosecuted.

A third category of protection covers the composition of matter of certain of the company’s DARPin product candidates (e.g., the specific combination and structure of DARPin binding proteins and additional elements that constitute the DARPin product candidate), as well as other product-specific inventions (e.g. formulation, manufacturing process or dosing schedule). The company’s patent applications and corresponding patents directed to the company’s DARPin product candidates include:

One example of a patent family that the company owns in this category is based on international patent application WO 2011/135067, relating to abicipar. As of December 31, 2022, the company owned four issued U.S. patents, one pending U.S. patent application, 63 issued foreign patents and five pending foreign patent applications in this family. Any issued patents in this family are expected to expire in 2031, not considering any patent term extensions that may be available in various jurisdictions if abicipar obtains regulatory approval there.

Another example of patent family in this category is based on international patent application WO 2016/156596, relating to MP0250. As of December 31, 2022, the company owned three issued U.S. patents, 11 issued foreign patents and 17 pending foreign patent applications in this family. Any patent that has been or may be granted in this patent family is expected to expire in 2036, not considering any patent term extensions that may be available in various jurisdictions if MP0250 obtains regulatory approval there.

Another example of a patent family in this category is based on international patent application WO 2018/054971, relating to MP0274. As of December 31, 2022, the company owned one issued U.S. patent, 11 issued foreign patents and 12 pending foreign patent applications in this family. Any patent that has been or may be granted in this patent family is expected to expire in 2037, not considering any patent term extensions that may be available in various jurisdictions if MP0274 obtains regulatory approval there.

Another example of a patent family in this category is based on international patent application WO 2020/245746, relating to MP0310. As of December 31, 2022, the company owned one pending U.S. patent application and 22 pending foreign patent applications in this family. Any patents that may be granted in this patent family are expected to expire in 2040, not considering any patent term extensions that may be available in various jurisdictions if MP0310 obtains regulatory approval there.

Other patent applications falling in this category have been filed, including patent applications relating to abicipar, MP0317, ensovibep, MP0423 and MP0533.

The company owns registrations for certain trademarks, including ‘Molecular Partners’, in Switzerland, the European Union, the United States and Japan.

License and Collaboration Agreements

License and Collaboration Agreement with Novartis in the Area of DARPIN Conjugated Radioligand Therapies

On December 14, 2021, the company entered into a license and collaboration agreement with Novartis to develop DARPin-conjugated radioligand therapeutic candidates for oncology, or the Novartis Radioligand Agreement. Under the agreement, both parties will collaborate on the discovery and optimization of the therapeutic candidates. The company is primarily responsible for the generation of DARPins for tumor-specific delivery of radioligands.

Option and Equity Rights Agreement with Novartis for Ensovibep

In October 2020, the company entered into an agreement with Novartis, granting Novartis the exclusive option to in-license global rights in relation to MP0420 (ensovibep), or the Option and Equity Rights Agreement.

License and Collaboration Agreement with Amgen

In December 2018, the company entered into a license and collaboration agreement with Amgen for the clinical development and commercialization of MP0310 / AMG 506, or the Amgen Collaboration Agreement.

Government Regulation and Product Approval

The company’s product candidates must be approved by the FDA before they may be legally marketed in the United States and by the appropriate foreign regulatory agency before they may be legally marketed in foreign countries.

Any products for which the company receives FDA approvals are subject to continuing regulation by the FDA, including among other things, record-keeping requirements, reporting of adverse experiences with the product, providing the FDA with updated safety and efficacy information, product sampling and distribution requirements, and complying with FDA promotion and advertising requirements, which include, among others, standards for direct-to-consumer advertising, restrictions on promoting products for uses or in patient populations that are not described in the product’s approved uses (known as ‘off-label use’), limitations on industry-sponsored scientific and educational activities, and requirements for promotional activities involving the internet.

Research and Development

Total research and development expenses in 2022 were CHF 50.7 million.

History

Molecular Partners AG was founded in 2004. The company was incorporated in 2004.