Interim Management Statement Q3 2020 of Molecular Partners: Emergence of New Opportunities and Strong Platform Validation of DARPin® Therapeutics

Interim Management Statement Q3 2020 of Molecular Partners: Emergence of New Opportunities and Strong Platform Validation of DARPin® Therapeutics

Zurich-Schlieren, Switzerland, October 29, 2020. Molecular Partners AG (SIX: MOLN), a clinical-stage biotech company that is developing a new class of custom-built protein drugs known as DARPin® therapeutics, announced today its interim management statement for the period ending September30, 2020.

“Responding to the global COVID-19 pandemic requires an unprecedented effort on the part of therapeutics innovators like Molecular Partners. We have used our pioneering knowledge of the unique DARPin® class to rapidly deliver what could be the first multi-specific treatment options for patients, which have formed the basis for a pivotal collaboration with Novartis. Its global development, regulatory & commercial capabilities will help rapidly bring the program forward with the potential to change the face of the pandemic,” said Patrick Amstutz, Ph.D., Chief Executive Officer of Molecular Partners. “Our work to date along with this highly validating partnership encourage our pursuit of other new initiatives in virology, in addition to our innovative oncology programs. We believe this pipeline evolution is a continued demonstration of the strength of our DARPin® leadership that has opened new avenues for delivering therapeutics that can achieve clinical outcomes other modalities cannot.”

 

Research & Development Highlights

Virology:

    • Collaboration with Novartis for co-development of MP0420 and MP0423, including options for global commercialization; leveraging innovative protein drug development expertise of Molecular Partners with Novartis’ expertise in global development and commercialization

    • Terms of the Novartis agreement include total cash considerations of CHF 210 million ($230 million USD), comprised of an upfront payment, equity purchase, and milestones, as well as a 22% royalty on sales in commercial territories

    • Receipt of reservation fee from Swiss Government, securing a minimum of 200,000 doses of MP0420 with provisions for up to an additional 3,000,000 doses

    • First-in-human studies of MP0420 expected to begin in November 2020

Oncology:

    • Continued AMG 506 (MP0310) (FAP x 4-1BB) phase 1 dose escalation study. Presentation of initial data describing dosing, safety and proof of mechanism anticipated by the end of 2020, with potential initiation of combination studies by Amgen in H2 2021

    • MP0274 (HER2+) phase 1 study to conclude after dose escalation with no additional studies planned. In total, 22 patients were treated with MP0274, the drug was found to be safe and well tolerated with a PR as best response.

    • MP0317 (FAP x CD40) on track for Clinical Trial Application filing expected before the end of 2020 with First-in-human study start expected to begin in H1 2021

 

Financial highlights:

    • Gross proceeds of CHF 80.2 million from share capital increase received in July 2020, providing anticipated financing into 2022

    • Cash and short-term deposits of CHF 133.8 million as of September 30, 2020

    • Net cash used in operating activities of CHF 31.3 million in first nine months of 2020

    • Operating loss of CHF 38.3 million and net loss of CHF 41.2 million in first nine months of 2020

    • On December 17, 2020 the Company plans to host an Investor & Analyst Day, highlighting recent accomplishments in both clinical development and research. This event will be held virtually, and will include commentary from senior management and Key Opinion Leaders.

 

Antiviral program: Ongoing prioritized development of two highly differentiated anti-COVID-19 multi-DARPin® candidates with unique advantages

In the first half of 2020, the Company began leveraging its rapid discovery and candidate design capabilities to deliver multi-target binding DARPin® proteins that neutralized the SARS-CoV-2 virus in vitro. These two candidates, identified as MP0420 and MP0423, exhibit among the highest potency in inhibiting SARS-CoV-2 live virus reported to-date, and in the third quarter 2020 the Company disclosed strong preliminary in vivo findings for both candidates.

The DARPin® technology offer a differentiated approach to treating COVID-19 through a single molecule that can engage with the spike protein of the SAR-CoV-2 virus with three DARPin® modules simultaneously to neutralize the virus. This offers potentially broader efficacy – across both therapeutic and prophylactic settings – and reduced potential for the development of viral drug resistance which can result from mutations that change any single molecular target. DARPin® candidates are also produced through rapid, high-yield microbial fermentation for potential speed, cost and scaling advantages over more complex mammalian cell production typically employed for antibody production.

In July 2020, the Company announced a partnership with AGC Biologics, a global biopharmaceutical contract development and manufacturing organization, to secure initial clinical and commercial-scale manufacturing capacity for the COVID-19 program. In August 2020, the Company announced the reservation by the Swiss Federal Office of Public Health: Bundesamt für Gesundheit (FOPH-BAG) of up to 3.2 million doses of MP0420, if the candidate is approved in Switzerland. Under the terms of the agreement, the Company immediately received a reservation fee in the mid to high single-digit millions of Swiss Francs.

In September, Molecular Partners completed the initial Good Manufacturing Practice (GMP) manufacturing runs of MP0420. More than 1 kg of DARPin® material was produced in each of the 100 liter E.coli-based bacterial fermenter runs.

In October, the Company announced further supportive preclinical data from in vivo assessments of its two DARPin® candidates targeting SARS-CoV-2. These candidates show robust activity in an aggressive viral challenge hamster model, supporting potential efficacy as therapeutic options in patients with late-stage disease. In a highly susceptible COVID-19 challenge model developed by expert virologists at Freie Universität Berlin, hamsters were first infected with SARS-CoV-2 and then administered either select doses of the two anti-COVID-19 DARPin® candidates or placebo, at either 0, 6, or 24 hours. In the five-day experiment, all animals treated with DARPin® molecules recovered and survived, while 83% of animals in the placebo group had to be euthanized due to severe disease progression.

Further, on October 27, the Company signed a collaboration with Novartis (SWX symbol: NOVN) for the co-development of MP0420 and MP0423 as well as options for global commercialization. This collaboration combines the innovative protein drug development expertise of Molecular Partners with Novartis’ expertise in clinical development, manufacturing, regulatory affairs & commercialization to accelerate global development of both candidates.

Under the terms of the collaboration agreement, Molecular Partners received a cash payment of CHF 20 million (~$22 million USD). As part of the transaction, Novartis also agreed to acquire CHF 40 million (~$44 million USD) worth of ordinary shares at a price of CHF 23 (~$25 USD) per share. As a result, Novartis now holds approximately 6% of the outstanding shares of Molecular Partners. Molecular Partners is eligible to receive a future milestone payment of CHF 150 million (~$165 million USD), upon Novartis exercising the option to both therapeutic candidates, and 22% royalty on sales. Molecular Partners has agreed to forgo royalties in lower income countries, and is aligned with Novartis’ plans to ensure affordability based on countries’ needs and capabilities.

Multiple characteristics of DARPin® therapeutics make them ideally suited for antiviral therapies, particularly at time of global need. Offering logistical solutions that other potential therapeutics in development may not possess, including (i) sub-picomolar potency, allowing investigation of subcutaneous administration as both early intervention and potential prophylaxis; (ii) highly scalable microbial manufacturing, allowing for up to 4 production runs on the same fermenter, per month; and (iii) high temperature stability of DARPin® drugs (>80°C) which may allow for avoidance of cumbersome cold chain storage. Molecular Partners is actively exploring opportunities to develop DARPin® therapeutics against other infectious diseases.

Immuno-oncology programs: Recruitment for AMG 506 (MP0310) continues in higher dose cohorts

Molecular Partners continued recruitment of patients with solid tumors in the ongoing phase 1 dose escalation study of AMG 506 (MP0310) (FAP x 4-1BB), in partnership with Amgen. AMG 506 (MP0310) is a tumor-localized immune agonist being evaluated in this phase 1 trial as a single agent in patients with advanced solid tumors. MP0310 includes localizer (FAP) and stimulator (4-1BB) DARPin® domains, which respectively provide tumor-specificity and immune activation. Initial presentation of data from the dose escalation cohorts are expected by year-end 2020 and will help inform potential phase 1b combination studies with Amgen assets which are anticipated to be conducted by Amgen.

For MP0317 (FAP x CD40), the Company’s second tumor-localized immune agonist, IND-enabling work continues to advance and Molecular Partners envisages a Clinical Trial Application (CTA) filing before the end 2020. A presentation at the World BiSpecific Forum in October 2020 underlined the mechanism of action and anti-tumor effects of this candidate.

For MP0274 (HER2+), after the completion of recruitment for the phase 1 trial already in the first half 2020, this trial will be concluded in Q4 2020. MP0274 is a multi-specific DARPin® product candidate being developed for the treatment of solid tumors with strong expression of the highly validated target protein HER2. In total 22 patients have received treatment with MP0274, one patient still continues on study. To date, MP0274 has been reported to be safe and well tolerated, and with one patient observed to have a Partial Response (PR). Presently, the Company does not plan any additional studies for MP0274.

For the phase 2 study of MP0250 (VEGF x HGF) in combination with the proteasome inhibitors (PIs) bortezomib (Velcade®) and dexamethasone in multiple myeloma, no new data were disclosed in the third quarter 2020 and no additional patients were enrolled into the study. The Company is evaluating potential clinical collaborations around MP0250, with updates anticipated before the end of 2020.

Abicipar

In Q3 2020, AbbVie withdrew its filings for abicipar with both the European Medicines Agency and the Japanese Regulatory Agency and is committed to working with these agencies to determine appropriate next steps and requirements for potential resubmissions for abicipar. Molecular Partners is in ongoing dialogue with AbbVie on the status of the program.

There is substantial need for better treatment options for nAMD and the Company remains confident in the totality of data supporting abicipar’s clinical profile for this indication, and continues to support AbbVie as it determines next steps.

Balance sheet: Strong cash and equity positions as of September 2020

Molecular Partners’ financial performance for the first nine months of 2020 reflects an operating cash outflow of CHF 31.3 million. In July 2020 the Company was able to reinforce its solid cash position with a private placement financing, raising gross proceeds of CHF 80.2 million. This further increases the Company’s financial flexibility to capture multiple value-creating inflection points into 2022. Moreover, in August 2020 Molecular Partners received a fee in the mid to high single digit millions of Swiss Francs from the Swiss Federal Office of Public Health: Bundesamt für Gesundheit (FOPH-BAG) as a purchase reservation fee for up to 3.2 million doses of MP0420.

As a consequence, cash and short-term deposits increased by CHF 69.4 million in Q3 2020 to CHF 133.8 million as of September 2020 (June 2020: CHF 64.4 million).

As of September 2020, the Company employed 143.4 FTEs, representing an 8% increase year-over-year, with approximately 85% of employees serving in R&D functions.

Business outlook and priorities

For the remainder of 2020, Molecular Partners will focus on advancing its immuno-oncology and infectious disease programs. For the COVID-19 program, the Company anticipates to start first-in-human studies for MP0420 in November 2020.

For AMG 506 (MP0310), following the planned reporting of initial data from the phase 1 study in December 2020, these data will be used to inform potential phase 1b combination studies with Amgen assets to be conducted by Amgen. For MP0317, the Company plans to file appropriate regulatory applications around the end of 2020 and expects to initiate clinical studies in the first half of 2021.

Financial outlook 2020

For the FY 2020, at constant exchange rates, the Company continues to expect total expenses in the range of CHF 65-75 million, of which approximately CHF 6.0 million will be non-cash effective costs. Capital expenditures in FY 2020 are expected to be approximately CHF 3.0 million.

Financial Calendar

  • December 17, 2020    R&D Day
  • February 5, 2021           Publication of FY 2020 results (unaudited)
  • March 26, 2021              Publication of FY 2020 Annual report

About DARPin® therapeutics

DARPin® therapeutics are a new class of custom-built protein therapeutics based on natural binding proteins that open a new dimension of multi-functionality and multi-target specificity in drug design. A single DARPin® candidate can engage more than five targets, and its flexible architecture and small size offer benefits over conventional monoclonal antibodies or other currently available protein therapeutics. DARPin® therapeutics have been clinically validated through to the registrational stage. The DARPin® platform is a fast and cost-effective drug discovery engine, producing drug candidates with optimized properties for development and very high production yields. DARPin® is a registered trademark owned by Molecular Partners AG.

About Molecular Partners AG

Molecular Partners AG is a clinical-stage biotech company developing a new class of custom-built protein drugs known as DARPin® therapeutics, designed to address challenges current modalities cannot. The company has compounds in various stages of clinical and preclinical development with a focus on oncology. Molecular Partners has formed partnerships with leading pharmaceutical companies to advance DARPin® therapeutics across multiple therapeutic areas. For more information regarding Molecular Partners AG visit www.molecularpartners.com or follow the company on Twitter @MolecularPrtnrs.

For further details, please contact:

Seth Lewis, SVP IR, Comms, & Strategy
seth.lewis@molecularpartners.com
Tel: +1 781 420 2361

Stefan Riley, U.S. Media
stefan@tenbridgecommunications.com
Tel: +1 617 461 2442

Thomas Schneckenburger, IR & European Media
thomas.schneckenburger@molecularpartners.com
Tel: +41 79 407 9952

Forward-looking statements

This press release may contain certain forward-looking statements relating to the company and its business. Although the company believes its expectations are based on reasonable assumptions, all statements other than statements of historical fact included in this press release about future events are subject to (i) change without notice and (ii) factors beyond the company’s control. These statements may include, without limitation, any statements preceded by, followed by, or including words such as “target,” “believe,” “expect,” “aim,” “intend,” “may,” “anticipate,” “estimate,” “plan,” “project,” “will,” “can have,” “likely,” “should,” “would,” “could”, and other words and terms of similar meaning or the negative thereof. Forward-looking statements involve certain risks, uncertainties and other factors which could cause the actual results, financial condition, performance or achievements of the company to be materially different from those expressed or implied by such statements. Readers should therefore not place undue reliance on these statements, particularly not in connection with any contract or investment decision. Except as required by law, the company assumes no obligation to update any such forward-looking statements, or to update the reasons actual results could differ materially from those anticipated in the forward-looking statements, even if new information becomes available in the future.

Molecular Partners announces collaboration with Novartis to develop two DARPin® therapies designed for potential use against COVID-19

    • Novartis has been granted an option to in-license global rights of MP0420 and MP0423 – multi-targeted direct-acting antiviral therapeutic candidates demonstrating potential efficacy against COVID-19

    • MP0420 and MP0423 are potential medicines with a unique approach for both the prevention and treatment of COVID-19, with the possibility to manufacture at scale, easy administration and with the potential to bypass cold storage

    • Molecular Partners, a global leader in the development of DARPin® therapeutics, will be responsible for the conduct of phase 1 & 2 trials that may lead to emergency use approval; Novartis will be responsible for further development, manufacturing, distribution and commercialization

    • This collaboration strengthens Novartis’ ongoing commitment to research and partner with other companies to find and develop treatment options for COVID-19 and make them available around the world as fast as possible

Zurich-Schlieren, Switzerland, October 28, 2020. Molecular Partners AG (SIX: MOLN), a clinical-stage biotech company that is developing a new class of custom-built protein drugs known as DARPin® therapeutics, and Novartis (SIX: NOVN) today announced a collaboration in the form of an option and license agreement to develop, manufacture and commercialize Molecular Partners’ anti-COVID-19 DARPin® program, consisting of two therapeutic candidates, MP0420 and MP0423. The collaboration aims to leverage Molecular Partners’ proprietary DARPin® technologies and Novartis’ broad expertise in global drug development, regulatory affairs, manufacturing and commercialization to rapidly advance the program in keeping with the unprecedented global urgency created by the pandemic.

Novartis is making multiple contributions to the global efforts to combat the COVID-19 pandemic. As part of those efforts, it has become increasingly clear that to tackle the pandemic at a global level the development of medicines that can prevent and treat the virus, in addition to the development of vaccines, will be crucial. Multiple treatment options increase the likelihood of reaching and treating patients around the world and, in addition, may be especially important for certain populations at greater risk who may benefit from a prophylactic treatment. MP0420 and MP0423 are potential medicines for the prevention and treatment of COVID-19, with the possibility of being manufactured at scale and potentially bypassing cold storage.

“Novartis remains unwavering in its support for tackling COVID-19 and it is clear that this pandemic calls for not just scientific solutions, but also for collaboration between companies to provide treatments in an area of high unmet need. This Swiss led partnership, which could deliver both prophylactic and treatment options at scale for COVID-19 patients across the globe, is another demonstration of our sustained commitment to addressing one of the greatest health challenges of our time,” said Vas Narasimhan, Chief Executive Officer of Novartis.

Under the agreement, during the option period, Molecular Partners will conduct Phase 1 clinical trials for MP0420, expected to begin in November 2020, and perform all remaining preclinical work for MP0423 and Novartis will conduct Phase 2 and Phase 3 clinical trials, with Molecular Partners as sponsor of these trials. Upon option exercise, Novartis would be responsible for all further development and commercialization activities. During the clinical development stage, Molecular Partners will provide clinical supply. The companies will work together to scale-up manufacturing capacity, in collaboration with Sandoz, the generics and biosimilar Novartis division, to provide worldwide supply.

Several characteristics of DARPin® therapeutics make them ideally suited for antiviral therapy including multi-specific target binding with the potential to prevent viral escape via mutations, the possibility for subcutaneous administration, long half-life for sustained activity, the potential to bypass cold storage and typically high-yield, highly scalable production in bacterial fermenters. These factors provide the possibility of developing and manufacturing this innovation at scale. This supports the commitment of both companies to leverage their respective strengths and expertise to urgently develop these two potential treatments and if the data are positive, facilitate access to these medicines for patients around the world as quickly as possible.

“Our team rapidly mobilized to deliver a unique DARPin®-based approach to address the overwhelming need for effective therapeutics against COVID-19. As a class, DARPin® therapeutics have demonstrated over years of clinical research a number of characteristics that enhance their profile as antiviral therapeutics for a global pandemic. We have built on this long-term research with these two candidates, which have demonstrated extremely potent neutralization of the virus through inhibiting multiple viral mechanisms,” said Patrick Amstutz, Chief Executive Officer of Molecular Partners. “We are thrilled to partner with Novartis, who has shown great commitment to combatting this pandemic and bringing innovative solutions to people around the world.”

Collaboration Terms and Share Subscription

Under the terms of the agreement, Molecular Partners will receive a cash payment of CHF 20 million (~$22 million USD). As part of the transaction, Novartis also agreed to acquire CHF 40 million (~$44 million USD) worth of ordinary shares with immediate effect, at a price of CHF 23 (~$25 USD) per share. As a result, Novartis will hold approximately 6% of the outstanding shares of Molecular Partners.

Molecular Partners is eligible to receive a future milestone payment of CHF 150 million (~$165 million USD), upon Novartis exercising the option to both therapeutic candidates, and 22% royalty on sales. Molecular Partners has agreed to forgo royalties in lower income countries, and is aligned with Novartis’ plans to ensure affordability based on countries’ needs and capabilities.

About Molecular Partners’ anti-COVID-19 program

Molecular Partners has developed a series of tri-specific antiviral DARPin® candidates with strong binding and neutralizing potency targeting multiple epitopes on the SARS-CoV-2 spike protein that are crucial for infection. The source of these constructs is a pool of hundreds of mono-DARPin® binders which individually bind and inhibit the virus with high potency. The construction of multi-specific candidates from monospecific proteins is the foundation of Molecular Partners’ drug discovery engine and has yielded multiple clinical candidates in other indications.

These building blocks are designed to target different sites on the virus for multiple concurrent effects. These include blocking viral binding to the human ACE2 receptor (Receptor Binder Domain or RBD), the primary docking mechanism to host cells, as well as allosteric inhibition or “molecular handcuffing”, of the spike protein, preventing the conformational change it undergoes prior to injection of viral RNA into the human cell.

The formatting as tri-specific candidates is designed for cooperative binding, extremely high potencies and prevention of viral escape via mutations. The candidates are formatted with a half-life enhanced DARPin® domain that binds to human serum albumin (HSA) to support long-acting activity. All DARPin® candidates are constructed to benefit from high-yield and low-cost microbial manufacturing. Molecular Partners is investigating whether the high thermal stability of DARPin® molecules can be used to overcome cold-chain requirements.

The ability of DARPin® products to be produced in E.coli-based biofermentation is a major advantage over antibodies, which often require substantial manufacturing process optimization and protein modification, significantly increasing cost and complexity. By contrast, DARPin® molecules are much smaller molecules that do not require glycosylation or extensive post-translational modification by producer cells, making simple, highly scalable bacterial fermentation feasible.

Molecular Partners is collaborating with AGC Biologics and Baccinex to support development of its anti-COVID-19 program, and has reached an agreement with the Swiss Government regarding rights to purchase up to 3.2 million doses of MP0420, if it is approved in Switzerland.

About DARPin® therapeutics

DARPin® therapeutics are a new class of custom-built protein therapeutics based on natural binding proteins that open a new dimension of multi-functionality and multi-target specificity in drug design. A single DARPin® candidate can engage more than five targets, and its flexible architecture and small size offer benefits over conventional monoclonal antibodies or other currently available protein therapeutics. DARPin® therapeutics have been clinically validated through to the registrational stage. The DARPin® platform is a fast and cost-effective drug discovery engine, producing drug candidates with optimized properties for development and very high production yields. DARPin® is a registered trademark owned by Molecular Partners AG.

About Molecular Partners AG

Molecular Partners AG is a clinical-stage biotech company developing a new class of custom-built protein drugs known as DARPin® therapeutics, designed to address challenges current modalities cannot. The company has compounds in various stages of clinical and preclinical development with a focus on oncology. Molecular Partners has formed partnerships with leading pharmaceutical companies to advance DARPin® therapeutics across multiple therapeutic areas. For more information regarding Molecular Partners AG visit www.molecularpartners.com or follow the company on Twitter @MolecularPrtnrs.

About Novartis

Novartis is reimagining medicine to improve and extend people’s lives. As a leading global medicines company, we use innovative science and digital technologies to create transformative treatments in areas of great medical need. In our quest to find new medicines, we consistently rank among the world’s top companies investing in research and development. Novartis medicines reach nearly 800 million people globally and we are finding innovative ways to expand access to our latest treatments. About 109,000 people of more than 140 nationalities work at Novartis around the world. Find out more at https://www.novartis.com.

For further details, please contact:

Seth Lewis, SVP IR, Comms, & Strategy
seth.lewis@molecularpartners.com
Tel: +1 781 420 2361

Stefan Riley, U.S. Media
stefan@tenbridgecommunications.com
Tel: +1 617 461 2442

Thomas Schneckenburger, IR & European Media
thomas.schneckenburger@molecularpartners.com
Tel: +41 79 407 9952

Forward-looking statements

This press release may contain certain forward-looking statements relating to the company and its business. Although the company believes its expectations are based on reasonable assumptions, all statements other than statements of historical fact included in this press release about future events are subject to (i) change without notice and (ii) factors beyond the company’s control. These statements may include, without limitation, any statements preceded by, followed by, or including words such as “target,” “believe,” “expect,” “aim,” “intend,” “may,” “anticipate,” “estimate,” “plan,” “project,” “will,” “can have,” “likely,” “should,” “would,” “could”, and other words and terms of similar meaning or the negative thereof. Forward-looking statements involve certain risks, uncertainties and other factors which could cause the actual results, financial condition, performance or achievements of the company to be materially different from those expressed or implied by such statements. Readers should therefore not place undue reliance on these statements, particularly not in connection with any contract or investment decision. Except as required by law, the company assumes no obligation to update any such forward-looking statements, or to update the reasons actual results could differ materially from those anticipated in the forward-looking statements, even if new information becomes available in the future.

Molecular Partners Demonstrates Reduction of Mortality and Potent Therapeutic Activity of Anti-COVID-19 DARPin® Candidates in Advanced COVID-19 Disease Model

    • DARPin® candidates demonstrate 100% survival in an aggressive viral challenge model
    • Data support utility of anti-COVID-19 DARPin® candidates as potent therapeutics
    • First-in-human clinical trial initiation of MP0420 planned for November 2020

Zurich-Schlieren, Switzerland, October 6, 2020. Molecular Partners AG (SIX: MOLN), a clinical-stage biotech company that is developing a new class of custom-built protein drugs known as DARPin® therapeutics, today announced supportive preclinical data from in vivo assessments of its DARPin® candidates targeting SARS-CoV-2. These candidates show robust activity in an aggressive viral challenge hamster model, supporting potential efficacy as therapeutic options in patients with late-stage disease.

In a highly susceptible COVID-19 challenge model developed by expert virologists at Freie Universität Berlin, hamsters were first infected with SARS-CoV-2 and then administered either select doses of the anti-COVID-19 DARPin® candidates, MP0420 or MP0423, or placebo, at either 0, 6, or 24 hours. In the five-day experiment, all animals treated with DARPin® molecules recovered and survived, while 83% of animals in the placebo group had to be euthanized due to severe disease progression.

“The clinical efficacy observed in both prophylactic and post exposure settings, especially in the context of the severity of disease displayed by our novel COVID-19 model, holds promise for this class of virus-neutralizing inhibitors in later line settings,” said Jakob Trimpert, DVM, Ph.D., Freie Universität Berlin, Institute of Virology, who served as lead investigator of the study.

“These recent data underscore the potent mechanism of action of our DARPin® therapeutic candidates in both prophylactic and therapeutic animal models, opening the door for clinical trials in both settings. We now have evidence that our candidates may offer therapeutic benefit for patients receiving intensive care or in rapid decline,” said Patrick Amstutz, chief executive officer of Molecular Partners. “We would like to thank our collaborators in Berlin for pioneering this novel hamster model to test COVID therapies. This model might be the only one that mimics a severe disease progression in humans, as most hamsters become terminally ill as early as day two after viral infection.”

First-in-human studies for MP0420 are anticipated to begin in November 2020, and clinical studies for the second antiviral candidate, MP0423, are expected to initiate in H1 2021.

About Molecular Partners’ anti-COVID-19 program

Molecular Partners has developed a series of tri-specific antiviral DARPin® candidates with strong binding and neutralizing potency targeting multiple epitopes on the SARS-CoV-2 spike protein that are crucial for infection. The source of these constructs is a pool of hundreds of mono-DARPin® binders which individually bind and inhibit the virus with high potency. The construction of multi-specific candidates from monospecific proteins is the foundation of Molecular Partners’ drug discovery engine and has yielded multiple clinical candidates in other indications.

These building blocks are designed to target different sites on the virus for multiple concurrent effects. These include blocking viral binding to the human ACE2 receptor (Receptor Binder Domain or RBD), the primary docking mechanism to host cells, as well as allosteric inhibition or “molecular handcuffing”, of the spike protein, preventing the conformational change it undergoes prior to injection of viral RNA into the human cell.

The formatting as tri-specific candidates is designed for cooperative binding, extremely high potencies and prevention of viral escape via mutations. The candidates are formatted with a half-life enhanced DARPin® domain that binds to human serum albumin (HSA) to support long-acting activity. All DARPin® candidates are constructed to benefit from high-yield and low-cost microbial manufacturing. Molecular Partners is investigating whether the high thermal stability of DARPin® molecules can be used to overcome cold-chain requirements.

The ability of DARPin® products to be produced in E.coli-based biofermentation is a major advantage over antibodies, which often require substantial manufacturing process optimization and protein modification, significantly increasing cost and complexity. By contrast, DARPin® molecules are much smaller molecules that do not require glycosylation or extensive post-translational modification by producer cells, making simple, highly scalable bacterial fermentation feasible.

Molecular Partners is collaborating with AGC Biologics to support development of its anti-COVID-19 program, and has reached an agreement with the Swiss Government regarding rights to purchase up to 3.2 million doses of MP0420, if it is approved in Switzerland.

About Molecular Partners AG

Molecular Partners AG is a clinical-stage biotech company developing a new class of custom-built protein drugs known as DARPin® therapeutics, designed to address challenges current modalities cannot. The company has compounds in various stages of clinical and preclinical development with a focus on oncology. Molecular Partners has formed partnerships with leading pharmaceutical companies to advance DARPin® therapeutics across multiple therapeutic areas.

For more information regarding Molecular Partners AG, go to: www.molecularpartners.com

For further details, please contact:

Seth Lewis, SVP IR, Comms, & Strategy
seth.lewis@molecularpartners.com
Tel: +1 781 420 2361

Stefan Riley, U.S. Media
stefan@tenbridgecommunications.com
Tel: +1 617 461 2442

Thomas Schneckenburger, IR & European Media
thomas.schneckenburger@molecularpartners.com
Tel: +41 79 407 9952

Forward-looking statements

This press release may contain certain forward-looking statements relating to the company and its business. Although the company believes its expectations are based on reasonable assumptions, all statements other than statements of historical fact included in this press release about future events are subject to (i) change without notice and (ii) factors beyond the company’s control. These statements may include, without limitation, any statements preceded by, followed by, or including words such as “target,” “believe,” “expect,” “aim,” “intend,” “may,” “anticipate,” “estimate,” “plan,” “project,” “will,” “can have,” “likely,” “should,” “would,” “could”, and other words and terms of similar meaning or the negative thereof. Forward-looking statements involve certain risks, uncertainties and other factors which could cause the actual results, financial condition, performance or achievements of the company to be materially different from those expressed or implied by such statements. Readers should therefore not place undue reliance on these statements, particularly not in connection with any contract or investment decision. Except as required by law, the company assumes no obligation to update any such forward-looking statements, or to update the reasons actual results could differ materially from those anticipated in the forward-looking statements, even if new information becomes available in the future.

Molecular Partners Presents Preclinical Data Supporting Tumor Localization Mechanism of its CD40 Agonist MP0317 at World Bispecific Summit

    • MP0317 activates multiple antitumor immune cell types in vitro when in the presence of tumor stroma associated FAP
    • MP0317 mouse surrogate localizes to FAP-expressing tumors and induces strong and durable anti-tumor responses without systemic toxicity, and demonstrates strong anti-tumor immune memory responses

Zurich-Schlieren, Switzerland, September 24, 2020. Molecular Partners AG (SIX: MOLN), a clinical-stage biotech company that is developing a new class of custom-built protein drugs known as DARPin® therapeutics, today announced the presentation of preclinical findings supporting the mechanism of MP0317, a tri-specific DARPin® product candidate that includes binding domains for fibroblast activation protein (FAP), CD40, and human serum albumin (HSA). The presentation, titled “Novel therapeutic design of tumor-targeted CD40 agonist DARPin® molecule leads to antitumor activity with limited toxicity”, will be presented today at 2pm (EDT) at the 11th Annual World Bispecific Summit by Clara Domke, a senior scientist oncology research at Molecular Partners.

Data presented demonstrate that a mouse surrogate MP0317 molecule induces FAP-dependent activation of B cells, dendritic cells and macrophages. FAP is expressed on activated cancer associated fibroblasts (CAF) and is overexpressed in the stroma of many solid tumors. Since MP0317 only activates these immune cells in the presence of FAP, MP0317 may avoid the dose-limiting side effects historically associated with systemic administration of CD40 antibodies. Additionally, in a FAP-positive colorectal cancer model, MP0317 induced complete tumor responses and demonstrated induction of an anti-tumor immunological memory, protecting the mice against subsequent tumor challenges without the need for additional treatment.

“Potent and situationally-activated antitumor therapies are an important new area for cancer treatment, when systemic toxicity can limit effective dosing of therapies with proven mechanisms like CD40 activation. With MP0317 we are tackling multiple kinds of cancer where highly fibrous, FAP-rich stromal tissue has historically presented a barrier to immune cell penetration. These data demonstrate the potential for turning this barrier into a target, by utilizing it as an anchor for the delivery of super-potent immunostimulatory molecules,” said Nicolas Leupin M.D., chief medical officer of Molecular Partners. “We look forward to filing appropriate regulatory applications for MP0317 around the end of 2020 and initiating clinical studies in the first half of 2021.”

The presentation will be made available on the company’s corporate website, www.molecularpartners.com.

About Molecular Partners’ Oncology Portfolio

DARPin® therapeutic candidates are uniquely versatile, custom-built molecules with the potential to help people suffering from a broad range of diseases, including cancer. Given their small size, multi-functional design and unique binding surfaces, DARPin® molecules can address molecular targets that have been difficult to access by other drug modalities, such as antibodies. Molecular Partners has delivered substantial proof-of-concept in its oncology portfolio by advancing investigational DARPin® therapeutics against highly validated targets such as HER2, HGF and VEGF into clinical studies. The Company has focused the next phase of its oncology portfolio strategy on exploring targets with novel mechanisms for selective and site-specific immune cell activation. Molecular Partners has designed DARPin® candidates to activate only when proximal to the target tumor, improving efficacy and potentially eliminating systemic off-target side effects. Promising immune modulators such as peptide-MHC complexes, 4-1BB and CD40 are also the target of novel DARPin® programs. Further, DARPin® approaches are applied to novel targets such as peptide MHC-complexes.

About Molecular Partners AG

Molecular Partners AG is a clinical-stage biotech company developing a new class of custom-built protein drugs known as DARPin® therapeutics, designed to address challenges current modalities cannot. The company has compounds in various stages of clinical and preclinical development with a focus on oncology. Molecular Partners has formed partnerships with leading pharmaceutical companies to advance DARPin® therapeutics across multiple therapeutic areas.

For more information regarding Molecular Partners AG, go to: www.molecularpartners.com

For further details, please contact:

Seth Lewis, SVP IR, Comms, & Strategy
seth.lewis@molecularpartners.com
Tel: +1 781 420 2361

Tom Donovan, U.S. Media
tom@tenbridgecommunications.com
Tel: +1 857 559 3397

Thomas Schneckenburger, IR & European Media
thomas.schneckenburger@molecularpartners.com
Tel: +41 79 407 9952

Forward-looking statements

This press release may contain certain forward-looking statements relating to the company and its business. Although the company believes its expectations are based on reasonable assumptions, all statements other than statements of historical fact included in this press release about future events are subject to (i) change without notice and (ii) factors beyond the company’s control. These statements may include, without limitation, any statements preceded by, followed by, or including words such as “target,” “believe,” “expect,” “aim,” “intend,” “may,” “anticipate,” “estimate,” “plan,” “project,” “will,” “can have,” “likely,” “should,” “would,” “could”, and other words and terms of similar meaning or the negative thereof. Forward-looking statements involve certain risks, uncertainties and other factors which could cause the actual results, financial condition, performance or achievements of the company to be materially different from those expressed or implied by such statements. Readers should therefore not place undue reliance on these statements, particularly not in connection with any contract or investment decision. Except as required by law, the company assumes no obligation to update any such forward-looking statements, or to update the reasons actual results could differ materially from those anticipated in the forward-looking statements, even if new information becomes available in the future.

Molecular Partners Completes GMP Manufacturing of Anti-COVID-19 DARPin® Candidate MP0420 for Clinical Use

    • High yields in bacterial fermentation systems support ability of DARPin® manufacturing to rapidly scale for global supply
    • First and only, tri-specific antiviral demonstrating potential best-in-class potency in vivo
    • First-in-human clinical trial initiation planned for November 2020

Zurich-Schlieren, Switzerland, September 14, 2020. Molecular Partners AG (SIX: MOLN), a clinical-stage biotech company that is developing a new class of custom-built protein drugs known as DARPin® therapeutics, today announced the completion of initial Good Manufacturing Practice (GMP) manufacturing runs of its tri-specific, antiviral DARPin® candidate for COVID-19, named MP0420. More than 1 kg of DARPin® material was produced in each of the 100 liter E.coli-based bacterial fermenter runs. This fermentation approach is relatively simple, rapid and scalable compared to typical antibody manufacturing approaches, further differentiating the DARPin® approach as a potential therapeutic and prophylactic option for COVID-19.

“We believe the highly distinct manufacturing profile of DARPin® candidates is a crucial element for successful therapeutic efforts underway. Given the number of teams pursuing therapeutic approaches to the novel coronavirus, and considering the need to make a drug available on a global basis, it is essential to demonstrate the ability to manufacture and deploy these medicines,” said Patrick Amstutz, PhD, chief executive officer of Molecular Partners. “Beyond the unique tri-specific mechanism and sub-picomolar potency demonstrated in vitro, our first GMP batches now support a target product profile for a COVID-19 candidate with simple, scalable manufacturing that could rapidly meet global need. We will further evaluate optimal dosage in our Phase 1 study initiating this fall.”

Characteristics of DARPin® Therapeutics make them ideally suited for antiviral therapies, particularly at time of global need. Offering logistical solutions that other potential therapeutics in development may not possess, including:

  • Sub-picomolar potency, allowing investigation of subcutaneous administration as both early intervention and potential prophylaxis*
  • Highly scalable microbial manufacturing, allowing for up to 4 production runs on the same fermenter, per month
  • High temperature stability of DARPin® drugs (>80°C) which may allow for avoidance of cumbersome cold chain storage

Bacterial fermenters can range upwards of 10,000L in size. A single such fermenter could enable the delivery of hundreds of thousands of doses of MP0420 on a monthly basis, if initial GMP yields and production speed are maintained.

First in human studies for MP0420 are anticipated to begin in November, 2020. Additional manufacturing slots have been secured over the next 6 months, including production in 1000L fermenters. These slots will be used to produce additional doses for MP0420, as well as for our second antiviral candidate for COVID-19, MP0423, with clinical studies anticipated in H1 2021.

About Molecular Partners’ anti-COVID-19 program

Molecular Partners has developed a series of tri-specific antiviral DARPin® candidates with strong binding and neutralizing potency targeting multiple epitopes on the SARS-CoV-2 spike protein that are crucial for infection. The source of these constructs is a pool of hundreds of mono-DARPin® binders which individually bind and inhibit the virus with high potency. The construction of multi-specific candidates from monospecific proteins is the foundation of Molecular Partners’ drug discovery engine and has yielded multiple clinical candidates in other indications.

These building blocks are designed to target different sites on the virus for multiple concurrent effects. These include blocking viral binding to the human ACE2 receptor (Receptor Binder Domain or RBD), the primary docking mechanism to host cells, as well as allosteric inhibition or “molecular handcuffing”, of the spike protein, preventing the conformational change it undergoes prior to injection of viral RNA into the human cell.

The formatting as tri-specific candidates is designed for cooperative binding, extremely high potencies and prevention of viral escape via mutations. The candidates are formatted with a half-life enhanced DARPin® domain that binds to human serum albumin (HSA) to support long-acting activity. All DARPin® candidates are constructed to benefit from high-yield and low-cost microbial manufacturing. Molecular Partners is investigating whether the high thermal stability of DARPin® molecules can be used to overcome cold-chain requirements.

The ability of DARPin® products to be produced in E.coli-based biofermentation is a major advantage over antibodies, which often require substantial manufacturing process optimization and protein modification, significantly increasing cost and complexity. By contrast, DARPin® molecules are much smaller molecules that do not require glycosylation or extensive post-translational modification by producer cells, making simple, highly scalable bacterial fermentation feasible.

Molecular Partners is collaborating with AGC Biologics to support development of its anti-COVID-19 program, and has reached an agreement with the Swiss Government regarding rights to purchase up to 3.2 million doses of MP0420, if it is approved in Switzerland.

About Molecular Partners AG

Molecular Partners AG is a clinical-stage biotech company developing a new class of custom-built protein drugs known as DARPin® therapeutics, designed to address challenges current modalities cannot. The company has compounds in various stages of clinical and preclinical development with a focus on oncology. Molecular Partners has formed partnerships with leading pharmaceutical companies to advance DARPin® therapeutics across multiple therapeutic areas.

For more information regarding Molecular Partners AG, go to: www.molecularpartners.com

For further details, please contact:

Seth Lewis, SVP IR, Comms, & Strategy
seth.lewis@molecularpartners.com
Tel: +1 781 420 2361

Tom Donovan, U.S. Media
tom@tenbridgecommunications.com
Tel: +1 857 559 3397

Thomas Schneckenburger, IR & European Media
thomas.schneckenburger@molecularpartners.com
Tel: +41 79 407 9952

Forward-looking statements

This press release may contain certain forward-looking statements relating to the company and its business. Although the company believes its expectations are based on reasonable assumptions, all statements other than statements of historical fact included in this press release about future events are subject to (i) change without notice and (ii) factors beyond the company’s control. These statements may include, without limitation, any statements preceded by, followed by, or including words such as “target,” “believe,” “expect,” “aim,” “intend,” “may,” “anticipate,” “estimate,” “plan,” “project,” “will,” “can have,” “likely,” “should,” “would,” “could”, and other words and terms of similar meaning or the negative thereof. Forward-looking statements involve certain risks, uncertainties and other factors which could cause the actual results, financial condition, performance or achievements of the company to be materially different from those expressed or implied by such statements. Readers should therefore not place undue reliance on these statements, particularly not in connection with any contract or investment decision. Except as required by law, the company assumes no obligation to update any such forward-looking statements, or to update the reasons actual results could differ materially from those anticipated in the forward-looking statements, even if new information becomes available in the future.

Molecular Partners to Present at HC Wainwright and Morgan Stanley Healthcare Conferences

Zurich-Schlieren, Switzerland, September 11, 2020. Molecular Partners AG (SIX: MOLN), a clinical-stage biotech company that is developing a new class of custom-built proteins known as DARPin® therapeutics, today announced that Patrick Amstutz, chief executive officer, will be presenting at the HC Wainwright 22nd Annual Global Investments Conference taking place September 14-16, 2020, as well as participating in a fireside chat at the Morgan Stanley Global Healthcare Conference taking place September 14-18, 2020.

Details for the presentations are as follows:

HC Wainwright 22nd Annual Global Investments Conference

Presentation Date:           Monday, September 14, 2020

Presentation Time:           11:30 a.m. ET

 

Morgan Stanley Global Healthcare Conference

Presentation Date:           Wednesday, September 16, 2020

Presentation Time:           1:15 p.m. ET

 

A webcast of the presentations will be available on the Molecular Partners website.

About Molecular Partners AG

Molecular Partners AG is a clinical-stage biotech company developing a new class of custom-built protein drugs known as DARPin® therapeutics, designed to address challenges current modalities cannot. The company has compounds in various stages of clinical and preclinical development with a focus on oncology. Molecular Partners has formed partnerships with leading pharmaceutical companies to advance DARPin® therapeutics across multiple therapeutic areas.

For further details, please contact:

Seth Lewis, SVP IR, Comms, & Strategy
seth.lewis@molecularpartners.com
Tel: +1 781 420 2361

Tom Donovan, U.S. Media
tom@tenbridgecommunications.com
Tel: +1 857 559 3397

Thomas Schneckenburger, IR & European Media
thomas.schneckenburger@molecularpartners.com
Tel: +41 79 407 9952

Molecular Partners reports corporate highlights and key financials for H1 2020

Research & Development:

    • Developed novel anti-COVID-19 multi-specific DARPin® candidates, of which MP0420 is being prepared for clinical trial initiation in Q4 2020. Initial in vitro and in vivo data highly supportive of unique mechanisms of action with ultra-potent anti-viral activity seen.
    • Secured partnership with AGC Biologics to meet initial projected clinical and commercial-scale manufacturing capacity for anti-COVID-19 program.
    • In August 2020, submitted a paper detailing the COVID-19 program R&D to the biology research preprint server bioRxiv including preliminary in vivo findings.
    • Presented supportive data from the AMG 506 (MP0310), MP0317 and peptide-MHC immuno-oncology programs at the American Academy of Cancer Research Virtual Annual Meeting.
    • Complete Response Letter received from U.S. FDA for abicipar pegol by strategic partner Allergan, an AbbVie Company. AbbVie to determine appropriate next steps with appropriate regulatory agencies.
    • In August 2020, concluded recruitment of phase 1 study of MP0274 (including two Her2-targeting DARPin® molecules) in patients with progressive Her2-positive cancer.

Team:

    • Appointed U.S. biotech executives Sandip Kapadia, Michael Vasconcelles, M.D., and Vito J. Palombella, Ph.D., to the Board of Directors at the Annual General Meeting of April 29, 2020.

Financial highlights:

    • Ongoing strong financial position with CHF 64.4 million in cash and short-term deposits as of June 30, 2020
    • In July 2020, received gross proceeds of CHF 80.2 million from share capital increase, ensuring financing into 2022
    • Net cash outflow from operating activities of CHF 27.9 million in H1 2020
    • FY 2020 expense guidance slightly increased to CHF 65-75 million (previously CHF 60-70 million)

 

Zurich-Schlieren, Switzerland, August 26, 2020. Molecular Partners AG (SIX: MOLN), a clinical-stage biotech company that is developing a new class of custom-built proteins known as DARPin® therapeutics, today announced its corporate highlights and unaudited financial results for the first half-year of 2020.

“Molecular Partners progressed and expanded our diverse portfolio in the first half of 2020. As a therapeutics innovator developing an entirely new class of drugs, COVID-19 represented an opportunity to deliver a highly differentiated therapeutic solution. We have rapidly advanced a novel anti-COVID-19 program, supported by strong preclinical data, and secured manufacturing capacity for initial clinical and commercial need. In parallel, we have advanced our immuno-oncology clinical recruitment and shared first proof-of-concept for our novel peptide-MHC program, an area that has been incredibly challenging for other biologic modalities,” said Patrick Amstutz, Ph.D., Chief Executive Officer of Molecular Partners. “We remain supportive of our ophthalmology partnership with AbbVie and, as we look forward, Molecular Partners is more strongly positioned than ever before to create value through our continual expansion of DARPin platform technologies that leverage the unique advantages of this class.”

 

Antiviral program: Rapid development of highly differentiated anti-COVID-19 multi-DARPin® candidates with unique advantages for addressing a global viral pandemic

In April 2020, the Company leveraged its rapid discovery and candidate design capabilities to deliver multi-target binding DARPin proteins that neutralized the SARS-CoV-2 virus in vitro. Tri-specific DARPin candidates, including MP0420, were selected with the ability to inactivate the virus through multiple mechanisms simultaneously – cooperative target binding – and generate stronger antiviral effects through these synergies. These candidates exhibit among the highest potency in inhibiting SARS-CoV-2 live virus reported to-date, and in August 2020 the Company disclosed strong preliminary in vivo findings.

The DARPin® technology offer a differentiated approach to treating COVID-19 through a single molecule that can engage with the spike protein of the SAR-CoV-2 virus with three DARPin® modules simultaneously to neutralize the virus. This offers potentially broader efficacy – across both therapeutic and prophylactic settings – and reduced potential for the development of viral drug resistance which can result from selection pressure on any single molecular target. DARPin candidates are also produced through rapid, high-yield microbial fermentation for potential speed and cost advantages over mammalian cell production typically employed for antibodies.

In July 2020, the Company announced a partnership with AGC Biologics, a global biopharmaceutical contract development and manufacturing organization to secure initial clinical and commercial-scale manufacturing capacity for the COVID-19 program. In August 2020, the Company announced the reservation by the Swiss Federal Office of Public Health: Bundesamt für Gesundheit (FOPH-BAG) of up to 3.2 million doses of MP0420, if the candidate is approved in Switzerland. Under the terms of the agreement, the Company immediately received a reservation fee in the mid to high single digit millions of Swiss Francs.

In August 2020 the Company submitted a paper to the biology research preprint server bioRxiv which recapped the Company’s anti-COVID-19 research program and disclosed strong preliminary in vivo findings, including dose-dependent trends for reduction of viral titer as well as protection against body weight loss and lung lesions. The paper is titled “Highly potent anti-SARS-CoV-2 multi-DARPin candidates”.

Molecular Partners plans to initiate clinical studies for its COVID-19 program in Q4 2020.

 

Immuno-oncology programs: Continued recruitment and proof-of-concept for peptide-MHC DARPin binders

In partnership with Amgen, the Company continued strong recruitment of patients with solid tumors in the phase 1 dose escalation study of AMG 506 (MP0310), a novel tumor-localized immune agonist. This phase 1 trial is evaluating AMG 506 (MP0310) as a single agent in patients with advanced solid tumors. Molecular Partners expect to report initial data from this study in H2 2020. Data from the dose escalation cohorts will be used to inform potential Ph1b combination studies with Amgen assets and will be conducted by Amgen. Additionally, the Company presented preclinical data at the American Academy for Cancer Research (AACR) describing the research supporting the optimal dose for this candidate in the ongoing clinical study.

For MP0317, the Company’s second tumor-localized immune agonist, IND-enabling work continues to advance. MP0317 includes localizer (FAP) and stimulator (CD40) DARPin domains, which respectively provide tumor-specificity and immune activation. The Company presented preclinical data at AACR strongly supporting the intended profile and mechanism of this candidate and anticipates filing an IND by the end of 2020.

For MP0274, recruitment for its phase 1 trial has concluded. MP0274 is a multi-specific DARPin® product candidate being developed for the treatment of solid tumors with strong expression of the highly validated target protein HER2. Molecular Partners anticipates reporting initial data from this study in H2 2020.

As of April 30, 2020, patients in the ongoing phase 2 study of MP0250 in combination with the proteasome inhibitors (PIs) bortezomib (Velcade®) and dexamethasone will be monitored per protocol and no additional patients will be enrolled into the study.

Finally, at AACR the Company also presented proof-of-concept data for its peptide-MHC DARPin program. The constructed DARPin proteins were observed to effectively activate T cells at a range of concentrations and to carry out highly targeted cell killing exclusively on those cells that were positive for the peptide target. This demonstrated proof-of-concept for the ability of DARPin therapeutics to effectively drug specific peptide-MHC complexes.

 

Ophthalmology: AbbVie receipt of CRL for abicipar and further regulatory engagement

In June, AbbVie received a Complete Response Letter (CRL) for the Biologics License Application (BLA) of abicipar. AbbVie has withdrawn its filings for abicipar with both the European Medicines Agency and the Japanese Regulatory Agency and is committed to working with these agencies to determine appropriate next steps and requirements for potential resubmissions for abicipar.

There is substantial need for better treatment options for nAMD and the Company remains confident in the totality of data supporting abicipar’s clinical profile for this indication, and continues to support AbbVie as it determines next steps.

 

Financial highlights: Private placement extends cash runway into 2022

Molecular Partners remains solidly funded to capture upcoming value inflection points. In the first six months of 2020, Molecular Partners recognized total revenues of CHF 7.5 million (H1 2019: CHF 13.6 million) and incurred total operating expenses of CHF 30.6 million (H1 2019: CHF 26.0 million). This led to an operating loss of CHF 23.1 million for the first six months in 2020 (H1 2019: Operating loss of CHF 12.4 million). In the first six months in 2020 the Company accounted for a net financial loss of CHF 1.6 million (H1 2019: Net financial loss of CHF 0.3 million). This resulted in a net loss of CHF 24.7 million for H1 2020 (H1 2019: Net loss of CHF 12.7 million).

The net cash outflow from operating activities during the first six months in 2020 was CHF 27.9 million (2019: net cash inflow of CHF 27.0 million). Including time deposits, the cash and cash equivalents position decreased by CHF 30.7 million vs. year-end 2019 to CHF 64.4 million as of June 30, 2020 (December 31, 2019: CHF 95.1 million).

Total shareholders’ equity stood at CHF 31.0 million as of June 30, 2020, a decrease of CHF 23.1 million (December 31, 2019: CHF 54.1 million). As of June 30, 2020, the Company employed 144 FTEs (full time equivalents), up 12% year-on-year. About 85% of the employees are employed in R&D-related functions.

Early July 2020, the Company was able to reinforce its solid cash position with a private placement financing, raising gross proceeds of CHF 80.2 million. This further increases Molecular Partner’s financial flexibility to capture multiple value-creating inflection points into 2022. To continue building its capacity to deliver innovative new therapeutic candidates and manage a growing clinical portfolio, the Company plans to invest in both its clinical programs as well as an expanded workforce.

Key figures as of June 30, 2020

Key Financials (unaudited) H1 2020 H1 2019 Change
(CHF million, except per share, FTE data)
Total revenues 7.5 13.6 -6.1
R&D expenses -25.1 -19.0 -6.1
G&A expenses -5.5 -7.0 1.5
Operating result -23.1 -12.4 -10.7
Net result -24.7 -12.7 -12.0
Basic net result per share (in CHF) -1.14 -0.60 -0.54
Net cash from (used in) operating activities -27.9 27.0 -54.9
Cash balance (incl. time deposits)
as of June 30
64.4 123.3 -58.9
Total shareholders’ equity
as of June 30
31.0 78.1 -47.1
Number of total FTE
as of June 30
143.6 127.7 15.9

Business outlook and priorities

In the second half of 2020, Molecular Partners will focus on advancing its immuno-oncology and antiviral programs. For the COVID-19 program, the Company plans to initiate clinical trials of MP0420 in Q4 2020 and advance additional candidate towards the clinic.

Molecular Partners expects to present additional data from its ongoing phase 2 trial of MP0250 in patients with multiple myeloma in combination with Velcade® (PI) in H2 2020. For AMG 506 (MP0310), following the planned reporting of initial data from the phase 1 study in H2 2020, these data will be used to inform potential Ph1b combination studies with Amgen assets to be conducted by Amgen. For MP0317, IND submission is anticipated around the end of 2020. The Company also plans to publish or present multiple updates across its portfolio at select scientific venues.

Financial outlook 2020

For the full year 2020, at constant exchange rates, the Company expects total expenses in the range of CHF 65-75 million (previously CHF 60-70 million), of which around CHF 6.0 million will be non-cash effective costs. This slightly increased guidance reflects the Company’s additional investments into its Covid-19 programs. Capital expenditures in FY 2020 are expected to be approximately CHF 3.0 million.

Documentation

The results presentation, this press release and the half-year 2020 report will be made available on www.molecularpartners.com after 7:00am (CET) on August 26, 2020.

H1 2020 conference call

Molecular Partners will hold a conference call and audio webcast on August 26, 2020, 2:00pm CET (1:00pm GMT, 8:00am EST).

In order to register for the H1 2020 conference call, please dial the following numbers approximately 10 minutes before the start of the presentation:

Switzerland / Europe                 +41 (0) 58 310 5000

UK                                                       +44 (0) 207 107 0613

USA                                                    +1 (1) 631 570 5613

Participants will have the opportunity to ask questions after the presentation.

Audio webcast

The H1 20 results presentation will be webcast live and will be made available on the Company’s website under the investor section. The replay will be available for 90 days following the presentation.

Financial Calendar

    • October 29, 2020             Interim Management Statement Q3 2020
    • December 2020                R&D Day in New York

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

About DARPin® therapeutics

DARPin® therapeutics are a new class of custom-built protein therapeutics based on natural binding proteins that open a new dimension of multi-functionality and multi-target specificity in drug design. A single DARPin® candidate can engage more than five targets, and its flexible architecture and small size offer benefits over conventional monoclonal antibodies or other currently available protein therapeutics. DARPin® therapeutics have been clinically validated through to the registrational stage. The DARPin® platform is a fast and cost-effective drug discovery engine, producing drug candidates with optimized properties for development and very high production yields. DARPin® is a registered trademark owned by Molecular Partners AG.

About Molecular Partners AG

Molecular Partners AG is a clinical-stage biotech company developing a new class of custom-built protein drugs known as DARPin® therapeutics, designed to address challenges current modalities cannot. The company has compounds in various stages of clinical and preclinical development with a focus on oncology. Molecular Partners has formed partnerships with leading pharmaceutical companies to advance DARPin® therapeutics across multiple therapeutic areas.

For further details, please contact:

Seth Lewis, SVP IR, Comms, & Strategy
seth.lewis@molecularpartners.com
Tel: +1 781 420 2361

Tom Donovan, U.S. Media
tom@tenbridgecommunications.com
Tel: +1 857 559 3397

Thomas Schneckenburger, IR & European Media
thomas.schneckenburger@molecularpartners.com
Tel: +41 79 407 9952

Disclaimer

This communication does not constitute an offer or invitation to subscribe for or purchase any securities of Molecular Partners AG. This publication may contain certain forward-looking statements and assessments or intentions concerning the company and its business. Such statements involve certain risks, uncertainties and other factors which could cause the actual results, financial condition, performance or achievements of the company to be materially different from those expressed or implied by such statements. Readers should therefore not place reliance on these statements, particularly not in connection with any contract or investment decision. The company disclaims any obligation to update these forward-looking statements, assessments or intent

Molecular Partners Announces Agreement with Swiss Government, Securing Rights to Purchase Doses of First Anti-COVID-19 DARPin® Program

  • Swiss Government will pay a reservation fee for the right to purchase up to 3.2 million doses of anti-COVID-19 DARPin® candidate, MP0420, for both therapeutic and potential prophylactic use
  • Purchase of these doses may occur following appropriate marketing authorization
  • Multi-specific antiviral program demonstrates best-in-class potency against live SARS-CoV-2 virus; Recent in vivo data additionally supportive of clinical development
  • Initial clinical studies planned for Q4 2020

Zurich-Schlieren, Switzerland, August 11, 2020. Molecular Partners AG (SIX: MOLN), a clinical-stage biotech company that is developing a new class of custom-built proteins known as DARPin® therapeutics, today announced the reservation by the Swiss Federal Office of Public Health: Bundesamt für Gesundheit (FOPH-BAG) of a defined number of initial doses of the company’s multi-specific DARPin® anti-COVID-19 candidate, MP0420. MP0420 builds on a unique three-in-one DARPin® architecture to enhance potency and with the potential to prevent viral escape, in addition to manufacturing process advantages.

“The Swiss Government’s support in advancing our novel antiviral DARPin® program is an encouraging signal as we rapidly build upon our strong preclinical data that shows best-in-class potency in neutralizing live virus and recently secured manufacturing capacity,” said Patrick Amstutz, Chief Executive Officer of Molecular Partners. “We have been able to confirm activity in a relevant in vivo model supporting the potential of our unique tri-DARPin® for tackling SARS-CoV-2, as we believe novel therapeutics will be an essential tool for addressing the COVID-19 global pandemic.”

The initial supply agreement secures the right to purchase 200,000 doses, with the potential to purchase up to an additional 3 million doses. Certain pricing provisions have been pre-negotiated, but remain subject to final therapeutic dose. Under the terms of the agreement, the Company will immediately receive a reservation fee in the high single digit millions Swiss Francs. This will secure priority access for the Swiss government to purchase reserved doses of MP0420, if clinical trials are successful and MP0420 is approved in Switzerland.

Molecular Partners has selected a lead candidate (MP0420) and a variant molecule for preclinical development. Recently the Company announced completion of in vitro potency assessments of its DARPin® candidates targeting live, replicating SARS-CoV-2 virus. These candidates showed extremely robust antiviral activity, with several candidates demonstrating complete neutralization with low picomolar potency. This suggests only small amounts of these candidates may be required for therapeutic effect, which complements the company’s ability to rapidly manufacture DARPin® candidates with high yields using relatively simple E.coli-based biofermentation. The company has secured large-scale GMP manufacturing with AGC Biologics with an initial capacity of 100 liters and up to 1000 liters over the longer-term, a scale which Molecular Partners estimates is suitable for development and initial global supply of patients in need.

The company plans to initiate clinical studies for the anti-COVID-19 program in Q4 2020.

About Molecular Partners’ anti-COVID-19 program

Molecular Partners has developed a series of tri-specific antiviral DARPin® candidates with strong binding and neutralizing potency targeting multiple epitopes on the SARS-CoV-2 spike protein that are crucial for infection. The source of these constructs is a pool of hundreds of mono-DARPin® binders which individually bind and inhibit the virus with high potency. These building blocks target different sites on the virus, including blocking binding to the human ACE2 receptor (Receptor Binder Domain or RBD), the virus’s primary docking mechanism to host cells and allosteric inhibition, or “handcuffing”, of the spike protein, preventing the conformational change it undergoes prior to injection of viral RNA into the human cell.

The formatting as tri-specific candidates allows for cooperative binding and with that unrivaled potencies and prevention of viral escape via mutations. The candidates are formatted with a half-life enhanced DARPin® domain that binds to human serum albumin (HSA) to support long-acting activity. All candidates will profit from high-yield and low-cost microbial manufacturing. It will be investigated if the high thermal stability can be used to overcome cold-chain requirements.

The construction of multi-specific candidates from monospecific proteins is the foundation of Molecular Partners’ drug discovery engine and has yielded multiple clinical candidates in other indications.

About DARPin® therapeutics

DARPin® therapeutics are a new class of custom-built protein therapeutics based on natural binding proteins that open a new dimension of multi-functionality and multi-target specificity in drug design. A single DARPin® candidate can engage more than five targets, and its flexible architecture and small size offer benefits over conventional monoclonal antibodies or other currently available protein therapeutics. DARPin® therapeutics have been clinically validated through to registration via the development of abicipar, Molecular Partners’ most advanced DARPin® drug candidate. The DARPin® platform is a fast and cost-effective drug discovery engine, producing drug candidates with optimized properties for development and very high production yields. DARPin® is a registered trademark owned by Molecular Partners AG.

About Molecular Partners AG

Molecular Partners is a clinical-stage biotech company developing a new class of custom-built protein therapeutics known as DARPin® therapeutics, designed to address challenges current modalities cannot. The company has compounds in various stages of clinical and preclinical development with a focus on oncology. Molecular Partners has formed partnerships with leading pharmaceutical companies to advance DARPin® therapeutics across multiple therapeutic areas.

For more information regarding Molecular Partners AG, go to: www.molecularpartners.com.

For further details, please contact:

Seth Lewis, SVP IR, Comms, & Strategy
seth.lewis@molecularpartners.com
Tel: +1 781 420 2361

Tom Donovan, U.S. Media
tom@tenbridgecommunications.com
Tel: +1 857 559 3397

Thomas Schneckenburger, IR & European Media
thomas.schneckenburger@molecularpartners.com
Tel: +41 79 407 9952

Disclaimer

This communication does not constitute an offer or invitation to subscribe for or purchase any securities of Molecular Partners AG. This publication may contain certain forward-looking statements and assessments or intentions concerning the company and its business. Such statements involve certain risks, uncertainties and other factors which could cause the actual results, financial condition, performance or achievements of the company to be materially different from those expressed or implied by such statements. Readers should therefore not place reliance on these statements, particularly not in connection with any contract or investment decision. The company disclaims any obligation to update these forward-looking statements, assessments or intentions.

Molecular Partners Provides Regulatory Update of European and Japanese Filings of Abicipar Pegol

Zurich-Schlieren, Switzerland, July 20, 2020. Molecular Partners AG (SIX: MOLN), a clinical-stage biotech company that is developing a new class of custom-built proteins known as DARPin® therapeutics, today announced that Allergan, an AbbVie company, has informed Molecular Partners of their intent to withdraw application filings with both the European Medicines Agency (EMA) and the Japanese Regulatory Agency (PMDA) for abicipar pegol, a novel DARPin therapeutic for patients with neovascular (wet) age-related macular degeneration (nAMD).

Following the recent decision from the U.S. Food and Drug Administration (FDA), AbbVie is committed to working with the regulatory agencies to determine the appropriate next steps and discuss requirements for potential resubmissions for abicipar pegol. The company continues to believe in the need for new treatment options for nAMD.

About Molecular Partners AG

Molecular Partners is a clinical-stage biotech company developing a new class of custom-built protein therapeutics known as DARPin® therapeutics, designed to address challenges current modalities cannot. The company has compounds in various stages of clinical and preclinical development with a focus on oncology. Molecular Partners has formed partnerships with leading pharmaceutical companies to advance DARPin® therapeutics across multiple therapeutic areas.

For more information regarding Molecular Partners AG, go to: www.molecularpartners.com.

For further details, please contact:

Seth Lewis, SVP IR, Comms, & Strategy
seth.lewis@molecularpartners.com
Tel: +1 781 420 2361

Tom Donovan, U.S. Media
tom@tenbridgecommunications.com
Tel: +1 857 559 3397

Thomas Schneckenburger, IR & European Media
thomas.schneckenburger@molecularpartners.com
Tel: +41 79 407 9952

Disclaimer

This communication does not constitute an offer or invitation to subscribe for or purchase any securities of Molecular Partners AG. This publication may contain certain forward-looking statements and assessments or intentions concerning the company and its business. Such statements involve certain risks, uncertainties and other factors which could cause the actual results, financial condition, performance or achievements of the company to be materially different from those expressed or implied by such statements. Readers should therefore not place reliance on these statements, particularly not in connection with any contract or investment decision. The company disclaims any obligation to update these forward-looking statements, assessments or intent

Molecular Partners to Collaborate with AGC Biologics for Manufacturing of Anti-COVID-19 DARPin® Program

  • Partnership secures initial clinical and commercial-scale microbial manufacturing capacity
  • The only tri-specific antiviral protein in development, with potential best-in-class potency
  • Clinical studies planned for Q4 2020

Zurich-Schlieren, Switzerland, July 9, 2020. Molecular Partners AG (SIX: MOLN), a clinical-stage biotech company that is developing a new class of custom-built proteins known as DARPin® therapeutics, today announced a collaboration with AGC Biologics, a global biopharmaceutical contract development and manufacturing organization (CDMO), to support development of the company’s tri-specific DARPin® anti-COVID-19 program. The company plans to initiate clinical studies for this program in the fourth quarter of 2020.

The parties will work together to deliver clinical and commercial-scale GMP manufacturing solutions at initial capacities of 100 liters and 1000 liters, a scale which Molecular Partners estimates is suitable for development and initial global supply of patients in need. This projection is based on established manufacturing properties of clinical-stage DARPin candidates, and the potency data produced to-date from the anti-COVID-19 program.

Preclinical testing supports a highly favorable target product profile, including a long half-life, high solubility, high temperature stability and ease of manufacturability via validated bacterial fermentation. This manufacturing approach is scalable and may bring a significant speed and cost advantage as other protein-based antiviral approaches, such as monoclonal antibodies, often require expensive, extensive manufacturing process development and optimization.

Molecular Partners’ DARPin platform constructs its protein therapeutics through the assembly of single, monospecific DARPin proteins into a multi-functional chain that can bind to several targets at once: a ‘multi-specific’ DARPin. In the case of its anti-COVID-19 program, Molecular Partners is focused on unique tri-specific modalities that can bind to three parts of the novel coronavirus simultaneously.

“Securing manufacturing capacity is a critical step in advancing our novel antiviral DARPin program to clinical readiness. We are moving this program quickly to patients, building upon our strong preclinical data that shows potential best in class potency in neutralizing live virus, and the wealth of our previous clinical experience with DARPin candidates,” said Patrick Amstutz, Chief Executive Officer of Molecular Partners. “We are greatly encouraged by the recent data supporting the potential of our unique tri-specific approach to target SARS-CoV-2, as we believe novel therapeutics will be an essential tool for addressing the global COVID-19 pandemic.”

“AGC Biologics is pleased to be working with Molecular Partners on such an essential and innovative program,” says AGC Biologics CBO Mark Womack. “We are very proud to work alongside Molecular Partners in the fight against COVID-19.”

Molecular Partners has selected a lead candidate (MP0420) and a variant molecule for preclinical development. Both are tri-specific multi-DARPin candidates that inhibit the virus in several assays to the lowest picomolar potency or the assay sensitivity limit. These data, in combination with the anticipated half-life, suggests that subcutaneous administration could potentially function as both a therapeutic for existing viral infection and a prophylactic.

About Molecular Partners’ anti-COVID-19 program

Molecular Partners has developed a series of tri-specific antiviral DARPin® candidates with strong binding and neutralizing potency targeting multiple epitopes on the SARS-CoV-2 spike protein that are crucial for infection. The source of these constructs is a pool of hundreds of mono-DARPin binders which individually bind and inhibit the virus with high potency. These building blocks target different sites on the virus, including blocking binding to the human ACE2 receptor (Receptor Binder Domain or RBD), the virus’s primary docking mechanism to host cells and allosteric inhibition, or “handcuffing”, of the spike protein, preventing the conformational change it undergoes prior to injection of viral RNA into the human cell.

The formatting as tri-specific candidates allows for cooperative binding and with that unrivaled potencies and prevention of viral escape via mutations. The candidates are formatted with a half-life enhanced DARPin® domain that binds to human serum albumin (HSA) to support long-acting activity. All candidates will profit from high-yield and low-cost microbial manufacturing. It will be investigated if the high thermal stability can be used to overcome cold-chain requirements.

The construction of multi-specific candidates from monospecific proteins is the foundation of Molecular Partners’ drug discovery engine and has yielded multiple clinical candidates in other indications.

About DARPin® therapeutics

DARPin® therapeutics are a new class of custom-built protein therapeutics based on natural binding proteins that open a new dimension of multi-functionality and multi-target specificity in drug design. A single DARPin® candidate can engage more than five targets, and its flexible architecture and small size offer benefits over conventional monoclonal antibodies or other currently available protein therapeutics. DARPin® therapeutics have been clinically validated through to the registrational stage. The DARPin® platform is a fast and cost-effective drug discovery engine, producing drug candidates with optimized properties for development and very high production yields. DARPin® is a registered trademark owned by Molecular Partners AG.

About AGC Biologics

AGC Biologics is a leading global Contract Development and Manufacturing Organization (CDMO) with a strong commitment to deliver the highest standard of service to clients and partners. The company currently employs more than 1,000 employees worldwide. AGC Biologics’ global network spans three continents, with cGMP-compliant facilities in Seattle, Washington; Boulder, Colorado; Copenhagen, Denmark; Heidelberg, Germany; and Chiba, Japan.

AGC Biologics offers deep industry expertise and unique customized services for the scale-up and cGMP manufacture of protein-based therapeutics, from pre-clinical to commercial mammalian and microbial production. Integrated service offerings include plasmid (GMP pDNA) manufacturing, cell line development, bioprocess development, formulation, analytical testing, antibody drug development and conjugation, cell banking and storage and protein expression, including the proprietary CHEF1® Expression System for mammalian production.

Learn more at www.agcbio.com .

About Molecular Partners AG

Molecular Partners is a clinical-stage biotech company developing a new class of custom-built protein therapeutics known as DARPin® therapeutics, designed to address challenges current modalities cannot. The company has compounds in various stages of clinical and preclinical development with a focus on oncology. Molecular Partners has formed partnerships with leading pharmaceutical companies to advance DARPin® therapeutics across multiple therapeutic areas.

For more information regarding Molecular Partners AG, go to: www.molecularpartners.com.

For further details, please contact:

Seth Lewis, SVP IR, Comms, & Strategy
seth.lewis@molecularpartners.com
Tel: +1 781 420 2361

Tom Donovan, U.S. Media
tom@tenbridgecommunications.com
Tel: +1 857 559 3397

Thomas Schneckenburger, IR & European Media
thomas.schneckenburger@molecularpartners.com
Tel: +41 79 407 9952

Disclaimer

This communication does not constitute an offer or invitation to subscribe for or purchase any securities of Molecular Partners AG. This publication may contain certain forward-looking statements and assessments or intentions concerning the company and its business. Such statements involve certain risks, uncertainties and other factors which could cause the actual results, financial condition, performance or achievements of the company to be materially different from those expressed or implied by such statements. Readers should therefore not place reliance on these statements, particularly not in connection with any contract or investment decision. The company disclaims any obligation to update these forward-looking statements, assessments or intentions.