Allergan and Molecular Partners Announce Topline Safety Results from MAPLE study of Abicipar pegol

Author: molecularpart

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Allergan and Molecular Partners Announce Topline Safety Results from MAPLE study of Abicipar pegol

The MAPLE study used a modified manufacturing process and demonstrated decreased intraocular inflammation

Previously reported positive Phase 3 results demonstrated the potential for abicipar to be the first anti-VEGF therapy to maintain initial vision gains in all patients on a true fixed 12-week dosing interval

Abicipar BLA submission to the FDA planned for first half of 2019

DUBLIN, IRELAND – April 2, 2019 – Allergan plc, (NYSE: AGN), a leading global pharmaceutical company and Molecular Partners (SIX: MOLN), a clinical-stage biotechnology company developing a new class of drugs known as DARPin® therapies, today announced topline safety results from MAPLE, a 28 week open-label study which enrolled 123 age-related Neovascular Macular Degeneration (nAMD) patients and evaluated the safety of abicipar produced via a modified manufacturing process. In this single arm study, treatment naïve or prior anti-VEGF treated patients received three monthly 2mg abicipar injections followed by 2mg injections every 8 weeks for up to a total of five injections through week 28.

As a result of the improvements in the manufacturing process, the incidence of intraocular inflammation (IOI) was 8.9 percent in the MAPLE study, which was lower than the rate observed in prior Phase 3 studies. Most IOI events were assessed as mild to moderate in severity. The incidence of severe IOI was 1.6 percent with one reported case of iritis and one reported case of uveitis. There were no reported cases of endophthalmitis or retinal vasculitis in this study.

“It is encouraging to see the lower incidence and type of IOI observed in this open label 28-week study,” said Raj Maturi, MD, Midwest Eye Institute & Associate Professor Ophthalmology, Indiana University School of Medicine. “In the Phase 3 trials previously reported, abicipar demonstrated potential that could transform the way physicians manage nAMD with anti-VEGF therapy. Abicipar could be the first fixed 12- week anti-VEGF treatment that improves visual outcomes in a real world setting for a large number of AMD patients.”

“The results of this open-label study enabled us to assess improvements to the manufacturing process for abicipar. The safety profile demonstrated in MAPLE gives us confidence to proceed and scale up manufacturing,” said David Nicholson, Chief Research and Development Officer, Allergan. “We plan to submit the abicipar BLA and continue to pursue manufacturing process improvements as we develop larger scale studies in additional disease states, such as Diabetic Macular Edema.”

“Clinical trial evidence has shown that fixed-interval dosing of anti-VEGF therapies administered either every month or every 8 weeks results in better visual outcomes compared to real world clinical outcomes. Abicipar could potentially be the first anti-VEGF therapy that is administered every 12 weeks with demonstrated maintenance of visual acuity for a large number of patients with nAMD. A fixed-interval Q12-week therapy would greatly reduce the treatment burden for these patients,” said Peter Kaiser, MD, Chaney Family Endowed Chair in Ophthalmology Research and Professor of Ophthalmology, Cleveland Clinic Cole Eye Institute.

“Abicipar is our first DARPin® candidate on track for BLA submission with the aim to become the first fixed 12-week anti VEGF drug in all patients with nAMD,” commented Michael T. Stumpp, COO of Molecular Partners. He added: “The safety data from the MAPLE trial are an important step in the further improvement of the manufacturing process of abicipar.”

Allergan expects to file the abicipar Biologics License Application (BLA) with the U.S. Food and Drug Administration (FDA) in the first half of 2019. Additional data from the MAPLE study will be presented at a scientific conference later in 2019.

About ABICIPAR CEDAR and SEQUOIA PHASE 3 TRIALS

Allergan plc and Molecular Partners previously announced results from two positive Phase 3 clinical trials, CEDAR and SEQUOIA for abicipar, a novel DARPin® therapy for the treatment of nAMD, demonstrating that both the 8-week and 12-week fixed-interval treatment regimens met the pre-specified primary endpoint of non-inferiority to ranibizumab. The primary endpoint measured the proportion of treated patients with stable vision at week 52. In both studies abicipar demonstrated similar efficacy after 6 or 8 injections, compared to 13 ranibizumab injections in the first year of this study.

In the CEDAR study, overall treatment-emergent adverse events were similar among the three treatment arms and reported in 73.7 percent, 81.1 percent and 73.2 percent of patients receiving abicipar Q8, abicipar Q12 and ranibizumab Q4, respectively. Incidence of intraocular inflammation events was similar among the two abicipar treatment groups but higher than the ranibizumab group and reported at 15.1 percent and 15.4 percent of patients in the abicipar Q8 and Q12 arms compared to 0 percent in the ranibizumab Q4.

In the SEQUOIA study, overall treatment-emergent adverse events were similar among the three treatment arms and reported in 78.3 percent, 78.0 percent and 74.0 percent of patients receiving abicipar Q8, abicipar Q12 and ranibizumab Q4, respectively. Incidence of intraocular inflammation events was similar among the two abicipar treatment groups but higher than the ranibizumab group and reported at 15.7 percent and 15.3 percent of patients in the abicipar Q8 and Q12 arms compared to 0.6 percent in the ranibizumab Q4 arm.

About Allergan plc

Allergan plc (NYSE: AGN), headquartered in Dublin, Ireland, is a bold, global pharmaceutical leader. Allergan is focused on developing, manufacturing and commercializing branded pharmaceutical, device, biologic, surgical and regenerative medicine products for patients around the world.

Allergan markets a portfolio of leading brands and best-in-class products primarily focused on four key therapeutic areas including medical aesthetics, eye care, central nervous system and gastroenterology.

Allergan is an industry leader in Open Science, a model of research and development, which defines our approach to identifying and developing game-changing ideas and innovation for better patient care. With this approach, Allergan has built one of the broadest development pipelines in the pharmaceutical industry.

Allergan’s success is powered by our global colleagues’ commitment to being Bold for Life. Together, we build bridges, power ideas, act fast and drive results for our customers and patients around the world by always doing what is right.

With commercial operations in approximately 100 countries, Allergan is committed to working with physicians, healthcare providers and patients to deliver innovative and meaningful treatments that help people around the world live longer, healthier lives every day.

For more information, visit Allergan’s website at www.Allergan.com.

Contacts Allergan

Investors:
Manisha Narasimhan, Ph.D., +1 (862) 261-7162

Media:
Amy Rose, +1 (862) 289-3072
Fran DeSena, +1 (862) 261-8820

Forward-Looking Statement

Statements contained in this press release that refer to future events or other non-historical facts are forward-looking statements that reflect Allergan’s current perspective on existing trends and information as of the date of this release. Actual results may differ materially from Allergan’s current expectations depending upon a number of factors affecting Allergan’s business. These factors include, among others, the difficulty of predicting the timing or outcome of FDA approvals or actions, if any; the impact of competitive products and pricing; market acceptance of and continued demand for Allergan’s products; the impact of uncertainty around timing of generic entry related to key products, including RESTASIS®, on our financial results; risks associated with divestitures, acquisitions, mergers and joint ventures; risks related to impairments; uncertainty associated with financial projections, projected cost reductions, projected debt reduction, projected synergies, restructurings, increased costs, and adverse tax consequences; difficulties or delays in manufacturing; and other risks and uncertainties detailed in Allergan’s periodic public filings with the Securities and Exchange Commission, including but not limited to Allergan’s Annual Report on Form 10-K for the year ended December 31, 2018. Except as expressly required by law, Allergan disclaims any intent or obligation to update these forward-looking statements.

About Molecular Partners AG

Molecular Partners AG is a clinical-stage biotechnology company that is developing a new class of therapies known as DARPin® therapies. The company continues to attract talented individuals who share the passion to develop breakthrough medicines for serious diseases. Molecular Partners has compounds in various stages of clinical and preclinical development and several more in the research stage, with a current focus on ophthalmology and oncology. The company establishes research and development partnerships with leading pharmaceutical companies and is backed by established biotech investors.

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

Contacts Molecular Partners AG

Dr. Patrick Amstutz, CEO
patrick.amstutz@molecularpartners.com
Tel: +41 (0) 44 755 77 00

Dr. Thomas Schneckenburger, IR & Media
thomas.schneckenburger@molecularpartners.com
Tel: +41 (0) 44 755 5728

Susan A. Noonan, IR USA
susan@sanoonan.com
Tel: +1 212 966 3650

Lisa Raffensperger, International Media
lisa@tenbridgecommunications.com
Tel: +1 617-903-8783

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.

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Molecular Partners to present pre-clinical data on its FAP x CD40 multi-DARPin® molecule and on DARPin® drug conjugates (DDCs) at the AACR 2019

Zurich-Schlieren, March 29, 2019. Molecular Partners AG (SIX: MOLN), a clinical-stage biotech company pioneering the use of DARPin® therapeutics* to treat serious diseases, today announced that the company will present new pre-clinical data highlighting the company’s immuno-oncology and DARPin® directed drug delivery (DDC) platforms at the Annual Meeting 2019 of the American Association of Cancer Research (AACR) in Atlanta.

Using Molecular Partners’ novel and modular immuno-oncology toolbox, the company has designed a targeted approach to activate CD40 selectively in the tumor microenvironment. This approach is based on a multi-specific DARPin® molecule that incorporates a DARPin® directed to fibroblast activation protein (FAP) to localize an agonistic CD40 DARPin selectively in solid tumors with the goal of increase efficacy while reducing systemic toxicity.  Preclinical data demonstrated that the company’s multi-specific FAP x CD40 DARPin® molecule induced FAP-dependent activation of B cells, dendritic cells and macrophages.

The versatility of DARPin® molecules also makes them an attractive alternative to antibodies for the development of drug conjugates. Molecular Partners has developed DARPin® drug conjugates (DDCs) in collaboration with ImmunoGen, Inc., (Nasdaq: IMGN), using a model EGFR multi-specific DARPin® molecule. The DDCs displayed antigen-specific activity across a panel of cell lines expressing EGFR. DARPin® drug conjugates combine the selectivity and potency observed with antibody drug conjugates and the novel modular design of DARPin® molecules to create specifically designed therapeutics.

“We are very pleased with our advancing pipeline of DARPin® based therapeutics which includes both DDCs and immuno-oncology agents.  The data presented at AACR showcase the innovative power of the DARPin® platform in the multi-specific biologics space,” commented Pamela A. Trail, Chief Scientific Officer of Molecular Partners.

The data will be presented at the following AACR 2019 sessions under the respective titles:

CD40: Tuesday, 2 April 2019, 8.00 am, section 25: 3251 / 1 – “Fibroblast activation protein (FAP)-selective delivery of CD40 agonistic DARPin® molecule for tumor-localized immune activation” (Rigamonti et al.)

DDC: Sunday, 31 March 2019, 1.00 pm, section 9: 215 / 6 – “Generation of site-specific DARPin® drug conjugates using EGFR as a model system” (Laviolette et al.)

Full details on the Molecular Partners’ sessions at AACR 2019 as well as all presentations can be found on the conference page. Following their presentation at the AACR, the posters will also be available on the corresponding section of the Molecular Partnerswebsite.

Financial Calendar

  • April 16, 2019 – Annual General Meeting
  • May 9, 2019 – Interim Management Statement Q1 2019
  • August 27, 2019 – Publication of Half-year Results 2019 (unaudited)
  • October 31, 2019 – Interim Management Statement Q3 2019

http://investors.molecularpartners.com/financial-calendar-and-events/

About the DARPin® Difference

DARPin® therapeutics are a new class of protein therapeutics opening an extra dimension of multi-specificity and multi-functionality. DARPin® candidates are potent, specific, safe and very versatile. They can engage more than 5 targets at once, offering potential benefits over those offered by conventional monoclonal antibodies or other currently available protein therapeutics. The DARPin® technology is a fast and cost-effective drug discovery engine, producing drug candidates with ideal properties for development and very high production yields.

With their good safety profile, low immunogenicity and long half-life in the bloodstream and the eye, DARPin® therapeutics have the potential to advance modern medicine and significantly improve the treatment of serious diseases, including cancer and sight-threatening disorders. Molecular Partners is partnering with Allergan to advance clinical programs in ophthalmology, and is advancing a proprietary pipeline of DARPin® drug candidates in oncology and immuno-oncology. The most advanced global product candidate is abicipar, a molecule currently in phase 3, in partnership with Allergan. Several DARPin® molecules for various ophthalmic indications are also in development. The most advanced DARPin® therapeutic candidate wholly owned by Molecular Partners, MP0250, is in phase 2 clinical development for the treatment of solid tumors and hematological tumors. MP0274, the second-most advanced DARPin® drug candidate owned by Molecular Partners, has broad anti-HER activity; it inhibits HER1, HER2 and HER3-mediated downstream signaling via Her2, leading to induction of apoptosis. MP0274 is currently in phase 1. The company’s lead immuno-oncology product candidate MP0310 is a FAP x 4-1BB multi-DARPin® therapeutic candidate designed to locally activate immune cells in the tumor by binding to FAP on tumor stromal cells (localizer) and co-stimulating T cells via 4-1BB (immune modulator). Molecular Partners has closed a collaboration agreement with Amgen for the exclusive clinical development and commercialization of MP0310. MP0310 is expected to enter into the clinic in H2 2019. Molecular Partners is also advancing a growing preclinical and research pipeline in immuno-oncology that features its ‘I/O toolbox’ and additional development programs. DARPin® is a registered trademark owned by Molecular Partners AG.

About Molecular Partners AG

Molecular Partners AG is a clinical-stage biotech company that is developing a new class of therapies known as DARPin®therapeutics. The company continues to attract talented individuals who share the passion to develop breakthrough medicines for serious diseases. Molecular Partners has compounds in various stages of clinical and preclinical development and several more in the research stage, with a current focus on oncology and immuno-oncology. The company establishes research and development partnerships with leading pharmaceutical companies and is backed by established biotech investors.

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

For further details, please contact:

Dr. Patrick Amstutz, CEO
patrick.amstutz@molecularpartners.com
Tel: +41 44 755 77 00

Dr. Thomas Schneckenburger, IR & Media
thomas.schneckenburger@molecularpartners.com
Tel: +41 44 755 5728

Susan A. Noonan, IR USA
susan@sanoonan.com
Tel: +1 212 966 3650

Lisa Raffensperger, International Media
lisa@tenbridgecommunications.com
Tel: +1 617 903 8783

*DARPin® is a registered trademark owned by Molecular Partners AG

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.

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Molecular Partners Publishes Invitation to Annual General Meeting 2019

Zurich-Schlieren, March 19, 2019. Molecular Partners AG (SIX: MOLN), a clinical-stage biotech company pioneering the use of DARPin® therapeutics* to treat serious diseases, today published the invitation to the Annual General Meeting 2019.

The Annual General Meeting will be held on Tuesday, April 16, 2019, 2.00 pm CET (doors open at 1.30 pm CET), at the registered office of the company:

Molecular Partners AG, Wagistrasse 14, 5th floor, 8952 Schlieren, Switzerland

Link to the Invitation to the Annual General Meeting 2019 with the corresponding agenda items.

Link zur Einladung zur Generalversammlung 2019 mit den zugehörigen Traktandenpunkten.

Financial Calendar

  • April 16, 2019 – Annual General Meeting
  • May 9, 2019 – Interim Management Statement Q1 2019
  • August 27, 2019 – Publication of Half-year Results 2019 (unaudited)
  • October 31, 2019 – Interim Management Statement Q3 2019

http://investors.molecularpartners.com/financial-calendar-and-events/

About the DARPin® Difference

DARPin® therapeutics are a new class of protein therapeutics opening an extra dimension of multi-specificity and multi-functionality. DARPin® candidates are potent, specific, safe and very versatile. They can engage more than 5 targets at once, offering potential benefits over those offered by conventional monoclonal antibodies or other currently available protein therapeutics. The DARPin® technology is a fast and cost-effective drug discovery engine, producing drug candidates with ideal properties for development and very high production yields.

With their good safety profile, low immunogenicity and long half-life in the bloodstream and the eye, DARPin® therapeutics have the potential to advance modern medicine and significantly improve the treatment of serious diseases, including cancer and sight-threatening disorders. Molecular Partners is partnering with Allergan to advance clinical programs in ophthalmology, and is advancing a proprietary pipeline of DARPin® drug candidates in oncology and immuno-oncology. The most advanced global product candidate is abicipar, a molecule currently in phase 3, in partnership with Allergan. Several DARPin® molecules for various ophthalmic indications are also in development. The most advanced DARPin® therapeutic candidate wholly owned by Molecular Partners, MP0250, is in phase 2 clinical development for the treatment of solid tumors and hematological tumors. MP0274, the second-most advanced DARPin® drug candidate owned by Molecular Partners, has broad anti-HER activity; it inhibits HER1, HER2 and HER3-mediated downstream signaling via Her2, leading to induction of apoptosis. MP0274 is currently in phase 1. The company’s lead immuno-oncology product candidate MP0310 is a FAP x 4-1BB multi-DARPin® therapeutic candidate designed to locally activate immune cells in the tumor by binding to FAP on tumor stromal cells (localizer) and co-stimulating T cells via 4-1BB (immune modulator). Molecular Partners has closed a collaboration agreement with Amgen for the exclusive clinical development and commercialization of MP0310. MP0310 is expected to enter into the clinic in H2 2019. Molecular Partners is also advancing a growing preclinical and research pipeline in immuno-oncology that features its ‘I/O toolbox’ and additional development programs. DARPin® is a registered trademark owned by Molecular Partners AG.

About Molecular Partners AG

Molecular Partners AG is a clinical-stage biotech company that is developing a new class of therapies known as DARPin®therapeutics. The company continues to attract talented individuals who share the passion to develop breakthrough medicines for serious diseases. Molecular Partners has compounds in various stages of clinical and preclinical development and several more in the research stage, with a current focus on oncology and immuno-oncology. The company establishes research and development partnerships with leading pharmaceutical companies and is backed by established biotech investors.

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

For further details, please contact:

Dr. Patrick Amstutz, CEO
patrick.amstutz@molecularpartners.com
Tel: +41 44 755 77 00

Dr. Thomas Schneckenburger, IR & Media
thomas.schneckenburger@molecularpartners.com
Tel: +41 44 755 5728

Susan A. Noonan, IR USA
susan@sanoonan.com
Tel: +1 212 966 3650

Lisa Raffensperger, International Media
lisa@tenbridgecommunications.com
Tel: +1 617 903 8783

*DARPin® is a registered trademark owned by Molecular Partners AG

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.

Posted on

Molecular Partners Publishes Audited Financial Results for 2018 and Annual Report 2018

Zurich-Schlieren, March 15, 2019. Molecular Partners AG (SIX: MOLN), a clinical-stage biotech company pioneering the use of DARPin® therapeutics* to treat serious diseases, today published its audited Financial Results for 2018 and the company’s 2018 Annual Report.

The Audited Financial Results for 2018 and the company’s 2018 Annual Report are available on the investors section of the company’ website.

Financial Calendar

  • March 19, 2019 – Expected Publication of Invitation to Annual General Meeting
  • April 16, 2019 – Annual General Meeting
  • May 9, 2019 – Interim Management Statement Q1 2019
  • August 27, 2019 – Publication of Half-year Results 2019 (unaudited)
  • October 31, 2019 – Interim Management Statement Q3 2019

http://investors.molecularpartners.com/financial-calendar-and-events/

About the DARPin® Difference

DARPin® therapeutics are a new class of protein therapeutics opening an extra dimension of multi-specificity and multi-functionality. DARPin® candidates are potent, specific, safe and very versatile. They can engage more than 5 targets at once, offering potential benefits over those offered by conventional monoclonal antibodies or other currently available protein therapeutics. The DARPin® technology is a fast and cost-effective drug discovery engine, producing drug candidates with ideal properties for development and very high production yields.

With their good safety profile, low immunogenicity and long half-life in the bloodstream and the eye, DARPin® therapeutics have the potential to advance modern medicine and significantly improve the treatment of serious diseases, including cancer and sight-threatening disorders. Molecular Partners is partnering with Allergan to advance clinical programs in ophthalmology, and is advancing a proprietary pipeline of DARPin® drug candidates in oncology and immuno-oncology. The most advanced global product candidate is abicipar, a molecule currently in phase 3, in partnership with Allergan. Several DARPin® molecules for various ophthalmic indications are also in development. The most advanced DARPin® therapeutic candidate wholly owned by Molecular Partners, MP0250, is in phase 2 clinical development for the treatment of solid tumors and hematological tumors. MP0274, the second-most advanced DARPin® drug candidate owned by Molecular Partners, has broad anti-HER activity; it inhibits HER1, HER2 and HER3-mediated downstream signaling via Her2, leading to induction of apoptosis. MP0274 is currently in phase 1. Molecular Partners is also advancing a growing preclinical pipeline that features several immuno-oncological development programs. DARPin® is a registered trademark owned by Molecular Partners AG.

About Molecular Partners AG

Molecular Partners AG is a clinical-stage biotech company that is developing a new class of therapies known as DARPin®therapeutics. The company continues to attract talented individuals who share the passion to develop breakthrough medicines for serious diseases. Molecular Partners has compounds in various stages of clinical and preclinical development and several more in the research stage, with a current focus on oncology and immuno-oncology. The company establishes research and development partnerships with leading pharmaceutical companies and is backed by established biotech investors.

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

For further details, please contact:

Dr. Patrick Amstutz, CEO
patrick.amstutz@molecularpartners.com
Tel: +41 44 755 77 00

Dr. Thomas Schneckenburger, IR & Media
thomas.schneckenburger@molecularpartners.com
Tel: +41 44 755 5728

Susan A. Noonan, IR USA
susan@sanoonan.com
Tel: +1 212 966 3650

Lisa Raffensperger, International Media
lisa@tenbridgecommunications.com
Tel: +1 617 903 8783

*DARPin® is a registered trademark owned by Molecular Partners AG

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.

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Molecular Partners to present at the Cowen and Company 39th Annual Healthcare Conference

Company to highlight the progress on its clinical DARPin® compounds, discuss MP0310 in its strategic partnership with Amgen and update on the initiation of a research project to explore DARPin® molecules targeting peptide MHC complexes supported by Gilead

Zurich-Schlieren, March 11, 2019. Molecular Partners AG (SIX: MOLN), a clinical-stage biotech company pioneering the use of DARPin® therapeutics* to treat serious diseases, today announced that it will present at the Cowen and Company 39th Annual Health Care Conference on Tuesday, March 12, 2019 at 12:00 – 12:30 PM Eastern Time (5:00 PM CET). The presentation, followed by a Q&A session, will be hosted by Dr. Patrick Amstutz, CEO of Molecular Partners.

Next to highlighting the progress of the clinical DARPin® compounds, the presentation will outline the evolution of the company’s therapeutic design space in oncology research, including the recent strategic partnership with Amgen on MP0310 (FAP x 4-1BB). The presentation will also outline the initiation of a research project to explore DARPin® molecules targeting peptide MHC complexes supported by Gilead. The ability to target peptide MHC complexes with DARPin® molecules has the potential to open the target space significantly, as these targets have been notoriously difficult to be addressed by any antibody-based approaches.

Audio webcast

The presentation will be webcast live. A copy of the presentation handout as well as a replay of the webcast will be made available on the company’s website www.molecularpartners.com under the Investors section. The replay will be available for 30 days following the presentation.

Financial Calendar

  • March 15, 2019 – Expected Publication of Annual Report 2018
  • April 16, 2019 – Annual General Meeting
  • May 9, 2019 – Interim Management Statement Q1 2019
  • August 27, 2019 – Publication of Half-year Results 2019 (unaudited)
  • October 31, 2019 – Interim Management Statement Q3 2019

http://investors.molecularpartners.com/financial-calendar-and-events/

About the DARPin® Difference

DARPin® therapeutics are a new class of protein therapeutics opening an extra dimension of multi-specificity and multi-functionality. DARPin® candidates are potent, specific, safe and very versatile. They can engage more than 5 targets at once, offering potential benefits over those offered by conventional monoclonal antibodies or other currently available protein therapeutics. The DARPin® technology is a fast and cost-effective drug discovery engine, producing drug candidates with ideal properties for development and very high production yields.

With their good safety profile, low immunogenicity and long half-life in the bloodstream and the eye, DARPin® therapeutics have the potential to advance modern medicine and significantly improve the treatment of serious diseases, including cancer and sight-threatening disorders. Molecular Partners is partnering with Allergan to advance clinical programs in ophthalmology, and is advancing a proprietary pipeline of DARPin® drug candidates in oncology and immuno-oncology. The most advanced global product candidate is abicipar, a molecule currently in phase 3, in partnership with Allergan. Several DARPin® molecules for various ophthalmic indications are also in development. The most advanced DARPin® therapeutic candidate wholly owned by Molecular Partners, MP0250, is in phase 2 clinical development for the treatment of solid tumors and hematological tumors. MP0274, the second-most advanced DARPin® drug candidate owned by Molecular Partners, has broad anti-HER activity; it inhibits HER1, HER2 and HER3-mediated downstream signaling via Her2, leading to induction of apoptosis. MP0274 is currently in phase 1. Molecular Partners is also advancing a growing preclinical pipeline that features several immuno-oncological development programs. DARPin® is a registered trademark owned by Molecular Partners AG.

About Molecular Partners AG

Molecular Partners AG is a clinical-stage biotech company that is developing a new class of therapies known as DARPin®therapeutics. The company continues to attract talented individuals who share the passion to develop breakthrough medicines for serious diseases. Molecular Partners has compounds in various stages of clinical and preclinical development and several more in the research stage, with a current focus on oncology and immuno-oncology. The company establishes research and development partnerships with leading pharmaceutical companies and is backed by established biotech investors.

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

For further details, please contact:

Dr. Patrick Amstutz, CEO
patrick.amstutz@molecularpartners.com
Tel: +41 44 755 77 00

Dr. Thomas Schneckenburger, IR & Media
thomas.schneckenburger@molecularpartners.com
Tel: +41 44 755 5728

Susan A. Noonan, IR USA
susan@sanoonan.com
Tel: +1 212 966 3650

Lisa Raffensperger, International Media
lisa@tenbridgecommunications.com
Tel: +1 617 903 8783

*DARPin® is a registered trademark owned by Molecular Partners AG

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.

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Molecular Partners reports key financials for FY 2018 and corporate highlights for Q4 2018

Company positioned for growth following positive phase 3 abicipar data and validation of DARPin® platform through Amgen collaboration

Research & Development:

  • MP0310: Molecular Partners and Amgen announced strategic collaboration for clinical development and commercialization of lead IO candidate MP0310 (FAP x 4-1BB), validating the company’s immuno-oncology toolbox and DARPin® platform; first-in-human trial planned for H2 2019
  • MP0250 and MP0274: Additional patient data of ongoing phase 2 trial of MP0250 in combination with Velcade® in MM support data observed in first patient cohort; Complementary phase 2 trial of MP0250 in combination with Pomalyst® (IMiD) in MM in preparation; Recruitment of first patient cohort for phase 1 trial of MP0274 completed
  • Abicipar (Allergan partnership): Phase 3 secondary endpoint data presented in Q4 2018 underline potential to become first fixed 12 week anti-VEGF for wet AMD; Allergan plans to file abicipar with the FDA in H1 2019 and expects results of MAPLE trial in H1 2019

Team:

  • Talent base of 118 full-time employees (+10% year-on-year), reflecting further build-out of oncology expertise

Financial Highlights:

  • Strong financial position with CHF 99.0 million in cash as of December 31, 2018
  • USD 50 million upfront payment from collaboration agreement with Amgen collected in January 2019
  • Net cash used in operating activities of CHF 42.5 million in 2018, reflecting further build-out of R&D and clinical pipeline
  • Operating loss of CHF 37.4 million and net loss of CHF 37.0 million in 2018
  • Company funded into H2 2020, which is beyond Allergan’s expected abicipar launch resulting in expected steady income stream for Molecular Partners

Zurich-Schlieren, Switzerland, February 7, 2019. Molecular Partners AG (SIX: MOLN), a clinical-stage biotech company pioneering the use of DARPin® therapeutics* to treat serious diseases, today announced its unaudited financial results for 2018 and corporate highlights for the fourth quarter 2018. The fourth quarter was marked by positive phase 3 efficacy data presented for abicipar as well as the initiation of a strategic collaboration with Amgen in the field of immuno-oncology, two key milestones for the company.

“This was an important year for Molecular Partners in our key focus areas of oncology and immuno-oncology, including the presentation of the clinical strategy for MP0250 and the further development of our immuno-oncology portfolio. In addition, our partnership with Amgen in immuno-oncology validates our innovative therapeutic designs and our successful transition into oncology,” said Dr. Patrick Amstutz, Chief Executive Officer of Molecular Partners. “Positive data from the ongoing trials of abicipar in ophthalmology continue to underscore the therapeutic power of the DARPin® platform. We are now preparing our company for the next phase of growth, marked by Allergan’s expected launch of abicipar as early as 2020.”

MP0250: Update on phase 2 trial of MP0250 plus Velcade®/dexamethasone in multiple myeloma at ASH and company’s R&D Day in New York; complementary trial of MP0250 plus Pomalyst®/dexamethasone starts in 2019

MP0250, Molecular Partners’ lead oncology asset, is a multi-DARPin® candidate that targets hepatocyte growth factor (HGF) and vascular endothelial growth factor (VEGF), targeting two prominent pathways involved in tumor progression. Both pathways contribute to adaptive resistance to several targeted therapies and MP0250 may have the potential to overcome such adaptive resistance mechanisms.

At the ASH conference in December 2018, the company presented an update on its ongoing phase 2 trial evaluating MP0250 in combination with bortezomib (Velcade®) and dexamethasone in patients with multiple myeloma who had failed standard therapies. Early data from eight patients of the expansion part as per cut-off date of January 31, 2019, support the data observed in the first patient cohort.

The company further discussed potential development strategies for MP0250 at its R&D Day in New York in December 2018 and revealed plans to initiate a second phase 2 trial for MP0250 in MM. In this complementary trial patients will be treated with MP0250 in combination with pomalidomide (Pomalyst®) and dexamethasone. These patients will be relapsed or refractory MM patients who have failed at least two lines of therapy including a proteasome inhibitor (PI) and an immunomodulatory drug (IMiD) with the most recent therapy being IMiD-based. The ongoing phase 2 trial for MP0250 in MM in combination with Velcade® and dexamethasone is updated to recruit patients with a proteasome inhibitor (PI) based regimen as the most recent therapy. Together, these trials will cover the two main backbones of MM therapy and offer patients the potential to extend treatment with their last-used drug. 

MP0250: Patient recruitment for phase 2 trial in Non-Small Cell Lung Cancer (NSCLC) ongoing

Molecular Partners is continuing patient recruitment for its ongoing phase 1b/2 clinical study of MP0250 in combination with osimertinib (Tagrisso®) in patients with EGFR-mutated Non-Small Cell Lung Cancer (NSCLC) who were pre-treated with osimertinib.

A total of seven patients have been recruited so far at the MP0250 dose of 8mg/kg, dosed every three weeks. As several patients are still on treatment, it is premature to present data on efficacy or toxicity at this point in time.

MP0274 in HER2-positive solid tumors: Recruitment of patient cohort in ongoing Phase 1 trial completed and dose escalation continues

MP0274 is a multi-DARPin® product candidate being developed for the treatment of HER2-positive solid tumors. In preclinical trials MP0274 inhibits downstream signaling pathways, and directly kills HER2-addicted tumor cells through the induction of apoptosis. This represents a new and differentiated mode of action as compared to current standard of care antibodies. Recruitment for the first patient cohort has been completed and the dose escalation phase continues.

MP0310: Strategic immuno-oncology collaboration will jointly develop MP0310 in combination with Amgen’s oncology assets

On December 19, 2018, the company announced a collaboration and license agreement for the clinical development and commercialization of MP0310 (FAP x 4-1BB). MP0310 is a preclinical molecule designed to locally activate immune cells in the tumor by binding to FAP on tumor stromal cells (localizer) and co-stimulating T cells via 4-1BB (immune modulator).

Under the terms of the agreement, Amgen obtains exclusive global development and commercial rights for MP0310. The parties will jointly evaluate MP0310 in combination with Amgen’s oncology pipeline products, including its investigational BiTE®(bispecific T cell engager) molecules. Under the collaboration, Molecular Partners retains certain rights to develop and commercialize its proprietary DARPin® pipeline products in combination with MP0310.

In January 2019, Molecular Partners collected an upfront payment of USD 50 million. The company is further eligible to receive up to USD 497 million in development, regulatory and commercial milestone payments, as well as double-digit, tiered royalties up to the high teens. The parties agreed to share the clinical development costs in defined percentages for the first three indications subject to certain conditions. For all additional clinical trials, Amgen is responsible for all development costs.

Immuno-oncology: Preclinical data on the company’s DARPin® toolbox and on MP0310 highlighted at multiple scientific conferences

In Q4 2018, the company presented preclinical data on MP0310 at multiple scientific conferences. Moreover, Molecular Partners presented data on FAP x CD40, a second multi-specific preclinical DARPin® molecule in immuno-oncology. In 2019, the company plans to further advance DARPin® candidates arising from its immuno-oncology toolbox as well as to test other differentiating therapeutic designs with its DARPin® approaches.

Abicipar: Potential to be the first fixed 12 week anti-VEGF for nAMD

In Q4 2018, Allergan presented phase 3 safety and efficacy data of abicipar from SEQUOIA and CEDAR, two ongoing and identical global phase 3 trials designed to assess the efficacy and safety of abicipar compared with ranibizumab (Lucentis®) in treatment-naive patients with neovascular age-related macular degeneration (nAMD). These data underscore abicipar’s potential to become the first fixed 12-week anti-VEGF therapeutic.

Allergan consequently reiterated its intention to file the abicipar BLA with the Food and Drug Administration (FDA) in H1 2019 and continues to plan the market launch for 2020. Additionally, Allergan expects to share results from the MAPLE study, testing a further optimized formulation of abicipar, in H1 2019.

Financial highlights: Collaboration with Amgen further increased solid financial flexibility

In the financial year 2018, Molecular Partners recognized total revenues of CHF 10.4 million (2017: CHF 20.0 million) and incurred total expenses of CHF 47.8 million (2017: CHF 45.8 million). This led to an operating loss of CHF 37.4 million for 2017 (2017: Operating loss of CHF 25.8 million). The net financial result of CHF 0.4 million recorded in 2018 remained on the same level as in 2017. This resulted in a 2018 net loss of CHF 37.0 million (2017: Net loss of CHF 25.4 million).

The net cash used for operating activities in 2018 was CHF 42.5 million (2017: net cash used of CHF 40.0 million). Including time deposits, the cash and cash equivalents position decreased by CHF 42.1 million vs. year-end 2017 to CHF 99.0 million as of December 31, 2018 (December 31, 2017: CHF 141.1 million). Total shareholders’ equity stood at CHF 91.7 million as of December 31, 2018, a decrease of CHF 25.0 million (December 31, 2017: CHF 116.7 million). The USD 50 million upfront payment from the strategic collaboration with Amgen was collected in January 2019 and further increases the company’s solid cash position with no debt on the balance sheet.

Key figures as of December 31, 2018

Key Financials (unaudited) FY 2018
 FY 2017 change
(CHF million, except per share, FTE data)
Total revenues 10.4 20.0 (9.6)
R&D expenses (38.2) (37.4) (0.8)
G&A expenses (9.6) (8.4) (1.2)
Operating result (37.4) (25.8) (11.6)
Net financial result 0.4 0.4 0.0
Net result (37.0) (25.4) (11.6)
Basic net result per share (in CHF) (1.75) (1.22) (0.53)
Net cash from (used in) operating activities (42.5) (40.0) (2.5)
Cash balance (incl. time deposits)
as of Dec. 31		 99.0 141.1 (42.1)
Total shareholders’ equity as of Dec. 31 91.7 116.7 (25.0)
Number of total FTE as of Dec. 31 117.7 107.8 9.9
– thereof in R&D 104.4 96.5 7.9
– thereof in G&A 13.3 11.3 2.0

As a result of the adoption of IFRS 15, deferred revenues as of December 31, 2017 of CHF 18.4 million were partly reclassified to equity (CHF 9.0 million) in the IFRS financial statements to reflect the accumulated past effect of the adoption as of January 1, 2018. The remaining portion of CHF 9.4 million was recognized as revenues due to the option exercise in relation to the Discovery Alliance Agreement with Allergan in 2018. The remaining revenue in 2018 was generated from the Amgen agreement in December 2018.

As of December 31, 2018, the company employed 118 FTE, up 10% compared to year-end 2017. About 90% of the employees are employed in R&D-related functions.

“In the course of 2018, Molecular Partners’ financial position continued to develop in line with our expectations. We were able to reinforce our solid cash position with the USD 50 million upfront payment from the strategic collaboration with Amgen. This further increases our financial flexibility to capture multiple value-creating inflection points into H2 2020, beyond Allergan’s expected market launch of abicipar and the related expected steady income stream from there on,” said Andreas Emmenegger, Chief Financial Officer of Molecular Partners. “As we are setting up our organization for growth, we plan to substantially increase investments, mainly into our clinical program as well as into the expansion of our workforce.”

Business outlook and priorities

In 2019, Molecular Partners will present additional data from its ongoing phase 2 trials of MP0250 in patients with multiple myeloma (MM). The company also expects to present initial data of its phase 1b/2 study of MP0250 in EGFR-mut NSCLC in 2019. The company also expects data in 2019 for MP0274, the proprietary, single-pathway DARPin® drug candidate for the treatment of HER2-positive cancer.

The company will continue to advance its DARPin® candidates within its immuno-oncology pipeline, and will present further research and preclinical data for additional therapeutic candidates resulting from the company’s immuno-oncology toolbox. For the company’s most advanced IO candidate, MP0310, Molecular Partners and its strategic collaboration partner Amgen expect to enter into a clinical phase 1 monotherapy trial in H2 2019.

In ophthalmology, following the differentiating phase 3 efficacy data of abicipar in patients with wet AMD, Allergan plans to file abicipar with the FDA in H1 2019. Allergan also continues to expect results from the MAPLE study, using the further optimized formulation of abicipar, in H1 2019. Molecular Partners will continue to support Allergan in advancing abicipar through the phase 3 trials and in further optimizing the abicipar formulation. Allergan indicated its intention to launch the phase 3 study for abicipar in DME in H2 2019. Finally, the company continues to support Allergan in advancing the three preclinical ophthalmology assets optioned-in from the existing research collaboration.

Financial outlook 2019

For the full year 2019, at constant exchange rates, the company expects total expenses of CHF 70-80 million, of which around CHF 7 million will be non-cash effective costs for share-based payments, IFRS pension accounting and depreciations. The increase versus the previous year is mainly driven by the progress of the company’s pipeline, additional clinical trials for MP0250, the start of manufacturing of phase 3 material for MP0250 as well as the budgeted growth of the company’s workforce. Capital expenditures in FY 2019 are expected to be approximately CHF 3 million.

This guidance is subject to the progress of the pipeline, mainly driven by manufacturing costs, the speed of enrollment of patients in clinical trials and data from research and development projects. No guidance can be provided with regard to net cash flow projections. Timelines and potential milestone payments for existing and potentially new partnerships are not disclosed.

Investor documentation of FY 2018 results

This FY 2018 press release as well as the FY 2018 results presentation are available on the investors section of the company’s website.

FY 2018 results presentation, conference call and audio webcast

Molecular Partners will hold the FY 2018 results presentation in its headquarters in Zurich-Schlieren on February 07, 2019, 2:00pm CET (1:00pm GMT, 8:00am EST). For those who are unable to participate in the live event, the company provides conference call and audio webcast capabilities.

In order to register for the FY 2018 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) 203 059 5862

USA: +1 (1) 631 570 5613

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

The FY 2018 audio webcast will be accessible, both live and as a replay, on the investors section of the company’s website www.molecularpartners.com, along with the accompanying presentation slides.

Financial Calendar

March 15, 2019 Expected Publication of Annual Report 2018
April 16, 2019 Annual General Meeting
May 9, 2019 Interim Management Statement Q1 2019
August 27, 2019 Publication of Half-year Results 2019 (unaudited)
October 31, 2019 Interim Management Statement Q3 2019

http://investors.molecularpartners.com/financial-calendar-and-events/

About the DARPin® Difference

DARPin® therapeutics are a new class of protein therapeutics opening an extra dimension of multi-specificity and multi-functionality. DARPin® candidates are potent, specific, safe and very versatile. They can engage more than 5 targets at once, offering potential benefits over those offered by conventional monoclonal antibodies or other currently available protein therapeutics. The DARPin® technology is a fast and cost-effective drug discovery engine, producing drug candidates with ideal properties for development and very high production yields.

With their good safety profile, low immunogenicity and long half-life in the bloodstream and the eye, DARPin® therapeutics have the potential to advance modern medicine and significantly improve the treatment of serious diseases, including cancer and sight-threatening disorders. Molecular Partners is partnering with Allergan to advance clinical programs in ophthalmology, and is advancing a proprietary pipeline of DARPin® drug candidates in oncology and immuno-oncology. The most advanced global product candidate is abicipar, a molecule currently in phase 3, in partnership with Allergan. Several DARPin® molecules for various ophthalmic indications are also in development. The most advanced DARPin® therapeutic candidate wholly owned by Molecular Partners, MP0250, is in phase 2 clinical development for the treatment of solid tumors and hematological tumors. MP0274, the second-most advanced DARPin® drug candidate owned by Molecular Partners, has broad anti-HER activity; it inhibits HER1, HER2 and HER3-mediated downstream signaling via Her2, leading to induction of apoptosis. MP0274 is currently in phase 1. Molecular Partners is also advancing a growing preclinical pipeline that features several immuno-oncological development programs. DARPin® is a registered trademark owned by Molecular Partners AG.

About Molecular Partners AG

Molecular Partners AG is a clinical-stage biotech company that is developing a new class of therapies known as DARPin®therapeutics. The company continues to attract talented individuals who share the passion to develop breakthrough medicines for serious diseases. Molecular Partners has compounds in various stages of clinical and preclinical development and several more in the research stage, with a current focus on oncology and immuno-oncology. The company establishes research and development partnerships with leading pharmaceutical companies and is backed by established biotech investors.

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

For further details, please contact:

Dr. Patrick Amstutz, CEO
patrick.amstutz@molecularpartners.com
Tel: +41 44 755 77 00

Thomas Schneckenburger, IR & Media
thomas.schneckenburger@molecularpartners.com
Tel: +41 44 755 5728

Susan A. Noonan, IR USA
susan@sanoonan.com
Tel: +1 212 966 3650

Lisa Raffensperger, International Media
lisa@tenbridgecommunications.com
Tel: +1 617 903 8783

*DARPin® is a registered trademark owned by Molecular Partners AG

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.

Posted on

Molecular Partners to Present at the 37th Annual J.P. Morgan Healthcare Conference

Company to highlight recent progress on clinical DARPin® compounds, its oncology research strategy and to discuss the strategic collaboration with Amgen on MP0310

Zurich-Schlieren, January 7, 2019. Molecular Partners AG (SIX: MOLN), a clinical-stage biotech company pioneering the use of DARPin® therapeutics* to treat serious diseases, today announced that it will present at the 37th Annual J.P. Morgan Healthcare Conference on Wednesday, January 9, 2019 at 8:00 AM Pacific Standard Time (11:00 AM Eastern Time; 5:00 PM CET). The presentation, followed by a Q&A session, will be hosted by Dr. Patrick Amstutz, CEO of Molecular Partners.

Beyond highlighting the progress of the clinical DARPin® compounds and the evolution of the company’s therapeutic design space in oncology research, the presentation will outline the collaboration and license agreement for the clinical development and commercialization of MP0310 (FAP x 4-1BB) which the company and Amgen (NASDAQ:AMGN) announced on December 19, 2018. MP0310 is a preclinical molecule designed to locally activate immune cells in the tumor by binding to FAP on tumor stromal cells (localizer) and co-stimulating T cells via 4-1BB (immune modulator).

Audio webcast

The presentation will be webcast live. A copy of the presentation handout as well as a replay of the webcast will be made available on the company’s website www.molecularpartners.com under the Investors section. The replay will be available for 30 days following the presentation.

Financial Calendar

  • February 7, 2019 – Publication of Full-year Results 2018 (unaudited)
  • March 15, 2019 – Expected Publication of Annual Report 2018
  • April 16, 2019 – Annual General Meeting
  • May 9, 2019 – Interim Management Statement Q1 2019

http://investors.molecularpartners.com/financial-calendar-and-events/

About the DARPin® Difference

DARPin® therapeutics are a new class of protein therapeutics opening an extra dimension of multi-specificity and multi-functionality. DARPin® candidates are potent, specific, safe and very versatile. They can engage more than 5 targets at once, offering potential benefits over those offered by conventional monoclonal antibodies or other currently available protein therapeutics.
The DARPin® technology is a fast and cost-effective drug discovery engine, producing drug candidates with ideal properties for development and very high production yields.

With their good safety profile, low immunogenicity and long half-life in the bloodstream and the eye, DARPin® therapeutics have the potential to advance modern medicine and significantly improve the treatment of serious diseases, including cancer and sight-threatening disorders. Molecular Partners is partnering with Allergan to advance clinical programs in ophthalmology, and is advancing a proprietary pipeline of DARPin® drug candidates in oncology and immuno-oncology. The most advanced global product candidate is abicipar, a molecule currently in phase 3, in partnership with Allergan. Several DARPin® molecules for various ophthalmic indications are also in development. The most advanced DARPin® therapeutic candidate wholly owned by Molecular Partners, MP0250, is in phase 2 clinical development for the treatment of solid tumors and hematological tumors. MP0274, the second-most advanced DARPin® drug candidate owned by Molecular Partners, has broad anti-HER activity; it inhibits HER1, HER2 and HER3-mediated downstream signaling via Her2, leading to induction of apoptosis. MP0274 is currently in phase 1. Molecular Partners is also advancing a growing preclinical pipeline that features several immuno-oncological development programs. DARPin® is a registered trademark owned by Molecular Partners AG.

About Molecular Partners AG

Molecular Partners AG is a clinical-stage biotech company that is developing a new class of therapies known as DARPin®therapeutics. The company continues to attract talented individuals who share the passion to develop breakthrough medicines for serious diseases. Molecular Partners has compounds in various stages of clinical and preclinical development and several more in the research stage, with a current focus on oncology and immuno-oncology. The company establishes research and development partnerships with leading pharmaceutical companies and is backed by established biotech investors.

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

For further details, please contact:

Dr. Patrick Amstutz, CEO
patrick.amstutz@molecularpartners.com
Tel: +41 44 755 77 00

Thomas Schneckenburger, IR Europe
thomas.schneckenburger@molecularpartners.com
Tel: +41 44 755 5728

Susan A. Noonan, IR USA
susan@sanoonan.com
Tel: +1 212 966 3650

Lisa Raffensperger, International Media
lisa@tenbridgecommunications.com
Tel: +1 617 903 8783

*DARPin® is a registered trademark owned by Molecular Partners AG

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.

Posted on

Molecular Partners and Amgen Announce Strategic Collaboration in Immuno-oncology

Parties Will Jointly Develop MP0310, a Pre-clinical FAP x 4-1BB Multi-Specific DARPin® Molecule, in Combination with Amgen’s Oncology Assets, Including BiTE® Molecules

Molecular Partners Retains Rights to Develop MP0310 in Combination With its Pipeline Products

 

ZURICH-SCHLIEREN, SWITZERLAND and THOUSAND OAKS, Calif.– (Dec. 19, 2018) – Molecular Partners AG (SIX: MOLN), a clinical-stage biotech company pioneering the use of DARPin® therapeutics, and Amgen (NASDAQ:AMGN) today announced a collaboration and license agreement for the clinical development and commercialization of MP0310 (FAP x 4-1BB). MP0310 is a preclinical molecule designed to locally activate immune cells in the tumor by binding to FAP on tumor stromal cells (localizer) and co-stimulating T cells via 4-1BB (immune modulator).

Under the terms of the agreement, Amgen obtains exclusive global development and commercial rights for MP0310. The parties will jointly evaluate MP0310 in combination with Amgen`s oncology pipeline products, including its investigational BiTE®(bispecific T cell engager) molecules. Under the collaboration, Molecular Partners retains certain rights to develop and commercialize its proprietary DARPin® pipeline products in combination with MP0310.

Molecular Partners will receive an upfront payment of $50 million and is eligible to receive up to $497 million in development, regulatory and commercial milestone payments, as well as double-digit, tiered royalties up to the high teens. The parties will share the clinical development costs in defined percentages for the first three indications subject to certain conditions. For all additional clinical trials, Amgen is responsible for all development costs.

“MP0310 is the first candidate out of our portfolio of localized and multi-specific immune-cell agonists. This collaboration with Amgen will allow us to test multiple combinations of MP0310 with other agents, leveraging the potential of MP0310. We anticipate MP0310 to enter the clinic in 2019,” said Dr. Patrick Amstutz, chief executive officer of Molecular Partners. “The partnership with Amgen underlines the potential of MP0310 and the DARPin platform to deliver novel therapeutic designs.”

“The field of immuno-oncology continues to rapidly evolve, and it’s our belief that combination treatments will have a major role to play in the future of cancer care,” said David M. Reese, M.D., executive vice president of Research and Development at Amgen. “We look forward to collaborating with Molecular Partners to combine MP0310 with certain oncology assets, including  BiTE®molecules, to deliver improved outcomes for patients.”

Conference call and audio webcast

Molecular Partners will host a conference call and audio webcast on December 19, 2018,
at 2:00pm CET (1:00pm GMT, 5:00am PST).

In order to register for the 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

Interested parties can access a corresponding audio webcast of the presentation. The webcast will be accessible, both live and as a replay, on the investors section of the company’s website, along with the accompanying presentation slides.

About DARPin® Therapeutics

DARPin® therapeutics are a new class of protein therapeutics opening an extra dimension of multi-specificity and multi-functionality. DARPin® candidates contain multiple designed ankyrin repeat binding domains and can engage more than five targets, offering potential benefits over conventional monoclonal antibodies or other currently available protein therapeutics. The DARPin® technology is a fast and cost-effective drug discovery engine, producing drug candidates with ideal properties for development and 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 that is developing a new class of therapies known as DARPin®therapeutics. The company continues to attract talented individuals who share the passion to develop breakthrough medicines for serious diseases. Molecular Partners has compounds in various stages of clinical and preclinical development and several more in the research stage, with a current focus on oncology and immuno-oncology. The company establishes research and development partnerships with leading pharmaceutical companies and is backed by established biotech investors.
For more information regarding Molecular Partners AG, go to: www.molecularpartners.com.

About BiTE® Technology

Bispecific T cell engager (BiTE®) antibody construct is an innovative technology that can be engineered to target any tumor antigen expressed by any type of cancer. The protein molecules are designed to kill malignant cells using the patient’s own immune system by bridging T cells to tumor cells. BiTE® antibody construct helps connect the T cells to the targeted cell, with the intent of causing T cells to inject toxins which trigger cancer cell death (apoptosis). Amgen is developing BiTE® antibody constructs to uniquely (or specifically) target numerous hematologic malignancies and solid tumors.

About Amgen’s Commitment to Oncology

Amgen is committed to helping patients take on some of the toughest cancers, such as those that have been resistant to drugs, those that progress rapidly through the body and those where limited treatment options exist. Amgen’s supportive care treatments help patients combat certain side effects of strong chemotherapy, and our targeted medicines and immunotherapies focus on more than a dozen different malignancies, ranging from blood cancers to solid tumors. With decades of experience providing therapies for cancer patients, Amgen continues to grow its portfolio of innovative and biosimilar oncology medicines.
For more information, follow us on www.twitter.com/amgenoncology.

About Amgen

Amgen is committed to unlocking the potential of biology for patients suffering from serious illnesses by discovering, developing, manufacturing and delivering innovative human therapeutics. This approach begins by using tools like advanced human genetics to unravel the complexities of disease and understand the fundamentals of human biology.

Amgen focuses on areas of high unmet medical need and leverages its expertise to strive for solutions that improve health outcomes and dramatically improve people’s lives. A biotechnology pioneer since 1980, Amgen has grown to be one of the world’s leading independent biotechnology companies, has reached millions of patients around the world and is developing a pipeline of medicines with breakaway potential.
For more information, visit www.amgen.com and follow us on www.twitter.com/amgen.

Amgen Forward-Looking Statements

This news release contains forward-looking statements that are based on the current expectations and beliefs of Amgen. All statements, other than statements of historical fact, are statements that could be deemed forward-looking statements, including estimates of revenues, operating margins, capital expenditures, cash, other financial metrics, expected legal, arbitration, political, regulatory or clinical results or practices, customer and prescriber patterns or practices, reimbursement activities and outcomes and other such estimates and results. Forward-looking statements involve significant risks and uncertainties, including those discussed below and more fully described in the Securities and Exchange Commission reports filed by Amgen, including its most recent annual report on Form 10-K and any subsequent periodic reports on Form 10-Q and current reports on Form 8-K. Unless otherwise noted, Amgen is providing this information as of the date of this news release and does not undertake any obligation to update any forward-looking statements contained in this document as a result of new information, future events or otherwise.

No forward-looking statement can be guaranteed, and actual results may differ materially from those Amgen project. Amgen’s results may be affected by its ability to successfully market both new and existing products domestically and internationally, clinical and regulatory developments involving current and future products, sales growth of recently launched products, competition from other products including biosimilars, difficulties or delays in manufacturing its products and global economic conditions. In addition, sales of Amgen’s products are affected by pricing pressure, political and public scrutiny and reimbursement policies imposed by third-party payers, including governments, private insurance plans and managed care providers and may be affected by regulatory, clinical and guideline developments and domestic and international trends toward managed care and healthcare cost containment. Furthermore, Amgen’s research, testing, pricing, marketing and other operations are subject to extensive regulation by domestic and foreign government regulatory authorities. Amgen or others could identify safety, side effects or manufacturing problems with its products, including its devices, after they are on the market. Amgen’s business may be impacted by government investigations, litigation and product liability claims. In addition, Amgen’s business may be impacted by the adoption of new tax legislation or exposure to additional tax liabilities. While Amgen routinely obtains patents for its products and technology, the protection offered by its patents and patent applications may be challenged, invalidated or circumvented by its competitors, or Amgen may fail to prevail in present and future intellectual property litigation. Amgen performs a substantial amount of its commercial manufacturing activities at a few key facilities, including in Puerto Rico, and also depends on third parties for a portion of its manufacturing activities, and limits on supply may constrain sales of certain of its current products and product candidate development. In addition, Amgen competes with other companies with respect to many of its marketed products as well as for the discovery and development of new products. Discovery or identification of new product candidates or development of new indications for existing products cannot be guaranteed and movement from concept to product is uncertain; consequently, there can be no guarantee that any particular product candidate or development of a new indication for an existing product will be successful and become a commercial product. Further, some raw materials, medical devices and component parts for Amgen’s products are supplied by sole third-party suppliers. Certain of Amgen’s distributors, customers and payers have substantial purchasing leverage in their dealings with Amgen. The discovery of significant problems with a product similar to one of Amgen’s products that implicate an entire class of products could have a material adverse effect on sales of the affected products and on its business and results of operations. Amgen’s efforts to acquire other companies or products and to integrate the operations of companies Amgen has acquired may not be successful. A breakdown, cyberattack or information security breach could compromise the confidentiality, integrity and availability of Amgen’s systems and Amgen’s data. Amgen’s stock price may be volatile and may be affected by a number of events. Amgen’s business performance could affect or limit the ability of the Amgen Board of Directors to declare a dividend or its ability to pay a dividend or repurchase its common stock. Amgen may not be able to access the capital and credit markets on terms that are favorable to it, or at all.

The scientific information discussed in this news release related to Amgen’s product candidates is preliminary and investigative. Such product candidates are not approved by the U.S. Food and Drug Administration, and no conclusions can or should be drawn regarding the safety or effectiveness of the product candidates.

Molecular Partners Forward-Looking Statements

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.

###

CONTACT: Amgen, Thousand Oaks
Kristen Davis, 805-447-3008(media)

Trish Hawkins, 805-447-5631 (media)
Arvind Sood, 805-447-1060 (investors)

CONTACT: Molecular Partners, Zurich-Schlieren, Switzerland
Patrick Amstutz, CEO, +41 44 755 77 00
Thomas Schneckenburger, +41 44 755 5728 (IR Europe)
Susan A. Noonan, +1 212 966 3650 (IR USA)
Lisa Raffensperger, +1 617 903 8783 (international media)

Posted on

Molecular Partners’ R&D Day in New York highlights progress of pipeline of DARPin® therapeutic candidates and dedicated research focus areas

Zurich-Schlieren and New York, December 6, 2018. Molecular Partners AG (SIX: MOLN), a clinical-stage biopharmaceutical company pioneering the use of DARPin® therapeutics* to treat serious diseases, today announces the continued progress of its pipeline of proprietary therapeutic product candidates in oncology and immuno-oncology, as well as in ophthalmology together with its partner Allergan.

On its R&D Day in New York, entitled “Building Tomorrow’s Breakthroughs,” the company elaborates on its refined development plans for its most advanced proprietary candidate MP0250 in multiple myeloma (MM). In particular, the company announces its intention to initiate a second phase 2 trial for MP0250 in MM. This complementary trial will recruit patients with relapsed or refractory MM who have failed at least two lines of therapy including a proteasome inhibitor and an immunomodulatory drug (IMiD) and in whom the most recent therapy was IMiD-based. Patients will be treated with MP0250 in combination with Pomalidomide® and dexamethasone. The design of the initial phase 2 trial for MP0250 in MM will be updated to recruit patients with a proteasome inhibitor (PI) based regimen as the most recent therapy. Those patients continue to be dosed with MP0250 in combination with Velcade® and dexamethasone.

Molecular Partners also presents additional preclinical data on MP0310, its most advanced multi-specific (FAP x 4-1BB) DARPin®immuno-oncology compound, which is expected to move into the clinic in 2019. In addition, data on FAP x CD40, a second multi-specific preclinical DARPin® therapeutic in immuno-oncology, will be presented.

“I am pleased to report on our progress in oncology and our efforts to build a sustainable pipeline of DARPin® therapeutics,” said Patrick Amstutz, Chief Executive Officer of Molecular Partners.

Pamela A. Trail, Chief Scientific Officer of the company, added: “Our unique DARPin® designs have the potential to translate into novel therapeutics across the landscape of oncology. Going forward, we will focus on several key areas of therapeutic intervention which are in the sweet spot of our DARPin® technology.”

In addition to an overview of the Molecular Partners clinical and preclinical pipeline, the R&D Day will feature presentations by the following experts:

  • Dr. Robert Orlowski, Chairman, Ad Interim, Director of Myeloma, Professor of Medicine Departments of Lymphoma/Myeloma and Experimental Therapeutics, MD Anderson Cancer Center
  • Dr. Yehia Hashad, Vice President and Global Head of Clinical Development, Ophthalmology, Allergan

Logistics

The R&D Day for institutional investors, sell-side analysts, investment bankers, and business development professionals will take place at The Yale Club, 50 Vanderbilt Avenue, New York City, from 11:30 am – 2:30 pm EST. To RSVP email Susan A. Noonan at susan@sanoonan.com.

Attendees are invited to check at 11:30 am EST. The presentations will begin at 12:00 pm, followed by a Q&A session. Lunch will be served.

Audio webcast

A respective audio webcast will be accessible, both live and as a replay, on the investors section of the company’s website, along with the accompanying presentation slides.

Financial Calendar

  • November 1, 2018 – Q3 2018 Management Statement
  • December 6, 2018 – R&D Day in New York
  • February 7, 2019 – Publication of Full-year Results 2018 (unaudited)
  • March 15, 2019 – Expected Publication of Annual Report 2018
  • April 16, 2019 – Annual General Meeting
  • May 9, 2019 – Interim Management Statement Q1 2019

http://investors.molecularpartners.com/financial-calendar-and-events/

About the DARPin® Difference

DARPin® therapeutics are a new class of protein therapeutics opening an extra dimension of multi-specificity and multi-functionality. DARPin® candidates are potent, specific, safe and very versatile. They can engage more than 5 targets at once, offering potential benefits over those offered by conventional monoclonal antibodies or other currently available protein therapeutics.
The DARPin® technology is a fast and cost-effective drug discovery engine, producing drug candidates with ideal properties for development and very high production yields.

With their good safety profile, low immunogenicity and long half-life in the bloodstream and the eye, DARPin® therapeutics have the potential to advance modern medicine and significantly improve the treatment of serious diseases, including cancer and sight-threatening disorders. Molecular Partners is partnering with Allergan to advance clinical programs in ophthalmology, and is advancing a proprietary pipeline of DARPin® drug candidates in oncology and immuno-oncology. The most advanced global product candidate is abicipar, a molecule currently in phase 3, in partnership with Allergan. Several DARPin® molecules for various ophthalmic indications are also in development. The most advanced DARPin® therapeutic candidate wholly owned by Molecular Partners, MP0250, is in phase 2 clinical development for the treatment of solid tumors and hematological tumors. MP0274, the second-most advanced DARPin® drug candidate owned by Molecular Partners, has broad anti-HER activity; it inhibits HER1, HER2 and HER3-mediated downstream signaling via Her2, leading to induction of apoptosis. MP0274 is currently in phase 1. Molecular Partners is also advancing a growing preclinical pipeline that features several immuno-oncological development programs. DARPin® is a registered trademark owned by Molecular Partners AG.

About Molecular Partners AG

Molecular Partners AG is a clinical-stage biopharmaceutical company that is developing a new class of therapies known as DARPin® therapeutics. With a management team that includes many of the founding scientists, the company continues to attract talented individuals who share the passion to develop breakthrough medicines for serious diseases. Molecular Partners has compounds in various stages of clinical and preclinical development and several more in the research stage, with a current focus on oncology and immuno-oncology. The company establishes research and development partnerships with leading pharmaceutical companies and is backed by established biotech investors.

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

For further details, please contact:

Dr. Patrick Amstutz, CEO
patrick.amstutz@molecularpartners.com
Tel: +41 44 755 77 00

Thomas Schneckenburger, IR Europe
thomas.schneckenburger@molecularpartners.com
Tel: +41 44 755 5728

Susan A. Noonan, IR USA
susan@sanoonan.com
Tel: +1 212 966 3650

Lisa Raffensperger, International Media
lisa@tenbridgecommunications.com
Tel: +1 617 903 8783

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.

*DARPin® is a registered trademark owned by Molecular Partners AG.

Posted on

Molecular Partners to Present New Data on Immuno-Oncology Pipeline at Upcoming Scientific Conferences

Zurich-Schlieren, November 6, 2018. Molecular Partners AG (SIX: MOLN), a clinical-stage biopharmaceutical company pioneering the use of DARPin® therapeutics* to treat serious diseases, today announced that the company plans to participate in several upcoming scientific conferences in November and December 2018. At these conferences listed below, members of the Molecular Partners team will present updated research and preclinical data on the company’s DARPin® “toolbox” as well as on MP0310, its most advanced multi-specific (FAP x 4-1BB) DARPin® immuno-oncology compound, and on FAP x CD40, a second multi-specific DARPin® immuno-oncology compound.

33th Annual Meeting of Society for Immunotherapy of Cancer (SITC)

  • Washington D.C., November 9-10, 2018
  • Focus: (1) MP0310 (FAP x 4-1BB); (2) FAP x CD40 candidate
  • Titles: (1) Preclinical identification of the pharmacologically active dose range of the tumor-targeted
    4-1BB agonist MP0310 based on tumor regression, receptor occupancy and CD8 T lymphocyte expansion;
    (2) Fibroblast activation protein (FAP)-selective delivery of CD40 agonistic DARPin® molecule for tumor-restricted immune activation

EORTC-NCI-AACR 2018

  • Dublin, November 14, 2018
  • Focus: FAP x CD40 candidate
  • Title: Bispecific CD40/FAP DARPin® molecule for tumor-restricted immune activation

PEGS Europe

  • Lisbon, November 16, 2018
  • Focus: MP0310 (FAP x 4-1BB)
  • Title: Tumor-targeted DARPin® drug candidates for tumor-restricted immune cell co-activation

4th Annual ICI Europe Summit

  • Berlin, November 29, 2018
  • Focus: FAP x CD40 candidate
  • Title: Fibroblast activation protein (FAP)-selective delivery of CD40 agonistic DARPin® protein for tumor-localized immune activation

Tumor Models London Meeting

  • London, December 6, 2018
  • Focus: MP0310 (FAP x 4-1BB)
  • Title: Preclinical animal models for therapeutic clinical dose predictions and PD assessment

IBC Antibody Engineering & Therapeutics

  • San Diego, December 13, 2018
  • Focus: MP0310 (FAP x 4-1BB)
  • Title: Cancer therapy revisited

The corresponding posters and/or presentations will be available on the company’s webpage after they are presented. Please visit the scientific presentations section of Molecular Partners’ website.

 

Financial Calendar

  • November 1, 2018 – Q3 2018 Management Statement
  • December 6, 2018 – R&D Day in New York
  • February 7, 2019 – Publication of Full-year Results 2018 (unaudited)
  • March 15, 2019 – Expected Publication of Annual Report 2018
  • April 16, 2019 – Annual General Meeting
  • May 9, 2019 – Interim Management Statement Q1 2019
  • August 27, 2019 – Publication of Half-year Results 2019 (unaudited)
  • October 31, 2019 – Interim Management Statement Q3 2019

http://investors.molecularpartners.com/financial-calendar-and-events/

About the DARPin® Difference

DARPin® therapeutics are a new class of protein therapeutics opening an extra dimension of multi-specificity and multi-functionality. DARPin® candidates are potent, specific, safe and very versatile. They can engage more than 5 targets at once, offering potential benefits over those offered by conventional monoclonal antibodies or other currently available protein therapeutics.
The DARPin® technology is a fast and cost-effective drug discovery engine, producing drug candidates with ideal properties for development and very high production yields.

With their good safety profile, low immunogenicity and long half-life in the bloodstream and the eye, DARPin® therapeutics have the potential to advance modern medicine and significantly improve the treatment of serious diseases, including cancer and sight-threatening disorders. Molecular Partners is partnering with Allergan to advance clinical programs in ophthalmology, and is advancing a proprietary pipeline of DARPin® drug candidates in oncology and immuno-oncology. The most advanced global product candidate is abicipar, a molecule currently in phase 3, in partnership with Allergan. Several DARPin® molecules for various ophthalmic indications are also in development. The most advanced DARPin® therapeutic candidate wholly owned by Molecular Partners, MP0250, is in phase 2 clinical development for the treatment of solid tumors and hematological tumors. MP0274, the second-most advanced DARPin® drug candidate owned by Molecular Partners, has broad anti-HER activity; it inhibits HER1, HER2 and HER3-mediated downstream signaling via Her2, leading to induction of apoptosis. MP0274 is currently in phase 1. Molecular Partners is also advancing a growing preclinical pipeline that features several immuno-oncological development programs. DARPin® is a registered trademark owned by Molecular Partners AG.

About Molecular Partners AG

Molecular Partners AG is a clinical-stage biopharmaceutical company that is developing a new class of therapies known as DARPin® therapeutics. With a management team that includes many of the founding scientists, the company continues to attract talented individuals who share the passion to develop breakthrough medicines for serious diseases. Molecular Partners has compounds in various stages of clinical and preclinical development and several more in the research stage, with a current focus on oncology and immuno-oncology. The company establishes research and development partnerships with leading pharmaceutical companies and is backed by established biotech investors.

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

For further details, please contact:

Dr. Patrick Amstutz, CEO
patrick.amstutz@molecularpartners.com
Tel: +41 44 755 77 00

Thomas Schneckenburger, IR Europe
thomas.schneckenburger@molecularpartners.com
Tel: +41 44 755 5728

Susan A. Noonan, IR USA
susan@sanoonan.com
Tel: +1 212 966 3650

Lisa Raffensperger, International Media
lisa@tenbridgecommunications.com
Tel: +1 617 903 8783

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.

*DARPin® is a registered trademark owned by Molecular Partners AG.