Molecular Partners to Present at the 38th Annual J.P. Morgan Healthcare Conference

Molecular Partners to Present at the 38th Annual J.P. Morgan Healthcare Conference

Zurich-Schlieren, Switzerland, January 6, 2020. 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 38th Annual J.P. Morgan Healthcare Conference on Thursday, January 16, 2020 at 9:00 AM Pacific Standard Time (12:00 PM Eastern Time; 6:00 PM CET). The presentation, followed by a Q&A session, will be hosted by Dr. Patrick Amstutz, CEO of Molecular Partners.

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 https://www.molecularpartners.com under the Investors section. The replay will be available for 30 days following the presentation.

Financial Calendar

February 6, 2020 Publication of Full-year Results 2019 (unaudited)
April 29, 2020 Annual General Meeting

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 can engage more than five targets, 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 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 in partnership with Allergan is abicipar, a molecule for which phase 3 data have been filed to the respective regulators in both the US and in Europe. Several DARPin® molecules for various ophthalmic indications are also in preclinical development. The most advanced DARPin® therapeutic candidate wholly owned by Molecular Partners, MP0250, is in phase 2 clinical development for the treatment of hematological tumors, and has been granted Orphan Drug Designation by the FDA’s Office of Orphan Products Development (OOPD). MP0274, the second-most advanced DARPin® candidate owned by Molecular Partners, binds to Her2 and inhibits downstream signaling, which leads 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. The molecule has entered in phase 1 of clinical development 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 such as novel therapeutic designs to target peptide-MHC complexes. 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:

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

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

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

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 Receives Orphan Drug Designation for MP0250 for Multiple Myeloma

Zurich-Schlieren, Switzerland, December 27, 2019. Molecular Partners AG (SIX:MOLN), a clinical-stage biotech company pioneering the use of DARPin® therapeutics to treat serious diseases, announces the receipt of Orphan Drug Designation by the US Food and Drug Administration (FDA) for its novel therapeutic, MP0250, for the treatment of Multiple Myeloma.

MP0250 is a first-in-class, tri-specific multi-DARPin® drug candidate neutralizing VEGF-A and HGF and is binding to human serum albumin to increase plasma half-life. The unique mechanism of action of MP0250 represents a new approach to targeting the tumor microenvironment and increase patients’ responses to already approved therapies for multiple myeloma, potentially even after progression.

The mission of the FDA’s Office of Orphan Products Development (OOPD) is to advance the evaluation and development of products that demonstrate promise for the diagnosis and/or treatment of rare diseases or conditions that affect fewer than 200,000 people in the U.S. In fulfilling that task, the OOPD evaluates scientific and clinical data submissions from sponsors to identify and designate products as promising for rare diseases and to further advance scientific development of such promising medical products. Orphan drug designation provides incentives for sponsors to develop products for rare diseases. These incentives may include a partial tax credit for certain clinical trial expenditures, the waiver of certain FDA user fees, and potential eligibility for seven years of orphan drug marketing exclusivity, if approved.

Financial Calendar

February 6, 2020 Publication of Full-year Results 2019 (unaudited)
April 29, 2020 Annual General Meeting

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 can engage more than five targets, 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 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 in partnership with Allergan is abicipar, a molecule for which phase 3 data have been filed to the respective regulators in both the US and in Europe. Several DARPin® molecules for various ophthalmic indications are also in preclinical development. The most advanced DARPin® therapeutic candidate wholly owned by Molecular Partners, MP0250, is in phase 2 clinical development for the treatment of hematological tumors. MP0274, the second-most advanced DARPin® candidate owned by Molecular Partners, binds to Her2 and inhibits downstream signaling, which leads 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. The molecule has entered in phase 1 of clinical development 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 such as novel therapeutic designs to target peptide-MHC complexes. 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:

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

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

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

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’ R&D Day in New York City highlights pipeline progress of DARPin® therapeutic candidates and provides updates on research activities

  • Nicolas Leupin, CMO, highlights progress in the development of all three DARPin® product candidates in clinical trials: MP0250 in phase 2 clinical development, MP0274 in phase 1, and MP0310 in co-development with
  • Recent data presented for MP0250 in relapsed/refractory multiple myeloma at ASH underline the drug’s unique ability to complement standard of care through its novel mechanism of action, focusing on the tumor microenvironment
  • Following initial discussions with potential collaborators, strategic decision to engage in partnership evaluation for MP0250 in lieu of initiating MP0250/IMiD phase 2
  • MP0317, a FAP x CD40 DARPin® molecule, nominated as the next IND candidate stemming from the company’s immuno-oncology DARPin® toolbox
  • Two-year data from the phase 3 trial on abicipar underline the drug’s potential to be the first true 12-week anti-VEGF for wet AMD
  • Daniel Steiner, SVP Research, highlights progress on novel therapeutic designs including tumor-localized immune-cell agonists, peptide-MHC complex DARPin® binders, and next-generation immune cell engagers

Zurich-Schlieren, Switzerland, December 12, 2019. Molecular Partners AG (SIX:MOLN), a clinical-stage biotech 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, as well as abicipar in ophthalmology.

“We are very proud to present the progress of our company over this past year. We continue to see success of our DARPin® platform, from its earliest inception, with abicipar, now on the verge of potential FDA approval, to the newest concepts of attacking previously unreachable targets in cancer, and beyond, with the emergence of our peptide-MHC platform. Our pipeline is set up to provide significant value for patients,” said Patrick Amstutz, Ph.D., Chief Executive Officer of Molecular Partners. “Today we will hear from both world-class key opinion leaders as well as our own team highlighting our expertise in drug development and clinical execution and how we will continue to succeed into 2020 and beyond.”

During its R&D Day in New York, entitled “Novel Therapeutic Designs Applied,” the company will provide updates on its clinical and preclinical programs, including:

Abicipar:

  • Presentation of recently updated two-year results from CEDAR and SEQUOIA demonstrate that vision gains observed after one year with every 8-week and every 12-week dosing were maintained in the second year (presented at AAO 2019).
  • Abicipar sustained vision gains in year two with quarterly injections compared to monthly ranibizumab.

MP0250:

  • As stated at the 61st Annual Meeting of the American Society of Hematology (ASH) last week, MP0250 continues to show long-lasting and deepening responses across a variety of patients with multiple myeloma in the relapsed/refractory setting. MP0250 has a novel mechanism of action, designed to target both VEGF and HGF. This design makes MP0250 ideally suited to attack the underlying disease and potentially improve sensitivity, or re-sensitize patients, to existing and emerging treatments.
  • The company also announced today its intent to evaluate partnering opportunities for MP0250. In conjunction with this endeavor, the company will not start the previously planned clinical trial investigating MP0250 in combination with an IMiD. This is aligned with the company’s corporate strategy to pursue combination data for the most relevant clinical combinations of MP0250, which would be more appropriately determined in collaboration with a partner.

“Given the dynamic landscape of current and emerging treatments for multiple myeloma, along with our strong data recently presented at ASH, we believe that aligning with a partner with an existing hematology franchise will be the best way to accelerate the MP0250 program through the clinic and into the treatment paradigm. In recent discussions with potential collaborators, it is obvious that the time for evaluating this opportunity is now,” said Nicolas Leupin, M.D., MBA, Chief Medical Officer of Molecular Partners.

MP0274:

  • Also discussed today is MP0274, the second-most advanced DARPin® drug candidate in the oncology pipeline. It has broad anti-HER activity, inhibiting HER1, HER2 and HER3-mediated downstream signaling via HER2, leading to induction of apoptosis.
  • The company continues to enroll patients and explore dosing in a phase 1 study.
  • Current dose levels are presently up to 8mg/kg, and initial data is anticipated in H1 2020.

MP0310 (AMG 506):

  • MP0310 is a multi-domain DARPin® targeting FAP x 4-1BB, designed to activate immune cells specifically in the tumor and not in the rest of the body, potentially delivering greater efficacy with fewer side effects. Preclinical studies of MP0310 have demonstrated immune T-cell activation restricted to solid tumor tissues, and strong CD8 T-cell activation and expansion in vitro and in vivo.
  • The initial phase 1 study, being conducted by Molecular Partners, was initiated in mid-2019, and dose escalation is underway. Current clinical timelines are on track with initial data expected in H2 2020. In collaboration with Amgen, the clinical program is then expected to expand into additional combination cohorts, to be conducted by Amgen.

Beyond these clinical updates, the company will also detail its growing preclinical pipeline, including the data on FAP x CD40, now designated MP0317, a second multi-specific preclinical DARPin® designed for localized activation. In addition to these updates, the company will highlight advances in the DARPin® discovery platform, including the advent of peptide-MHC targeting and next-generation T-cell engagers.

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

  • Jeremy Wolfe, Practicing Ophthalmology Specialist
  • Stefan Knop, Department Head Hematology, University of Würzburg, Germany
  • Jordi Rodon, Associate Professor, Department of Investigational Cancer Therapeutics, MD Anderson Cancer Center

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 7:30 am – 10:00 am EST. To RSVP email Seth Lewis at seth.lewis@molecularpartners.com.
Breakfast starts at 7:30 am EST. The presentations will begin at 8:00 am, followed by a Q&A session.

Audio webcast

The event will be webcast live and will be made available on the company’s website under the Investors section. The replay will be available for 90 days following the presentation.

Financial Calendar

February 6, 2020 Publication of Full-year Results 2019 (unaudited)
April 29, 2020 Annual General Meeting

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 can engage more than five targets, 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 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 in partnership with Allergan is abicipar, a molecule for which phase 3 data have been filed to the respective regulators in both the US and in Europe. Several DARPin® molecules for various ophthalmic indications are also in preclinical development. The most advanced DARPin® therapeutic candidate wholly owned by Molecular Partners, MP0250, is in phase 2 clinical development for the treatment of hematological tumors. MP0274, the second-most advanced DARPin® candidate owned by Molecular Partners, binds to Her2 and inhibits downstream signaling, which leads 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. The molecule has entered in phase 1 of clinical development 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 such as novel therapeutic designs to target peptide-MHC complexes. 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:

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

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

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

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 Presents Updated Results of MP0250 in Patients with Relapsed/Refractory Multiple Myeloma (MM) at American Society of Hematology Annual Meeting

  • Poster highlights Overall Response Rate (ORR) of 45% in heavily pretreated MM population

  • Strong evidence of durable and deepening responses with ongoing treatment in excess of 9 months in multiple patients, including one patient who achieved a Complete Response (CR)

  • Mechanism of action targeting the microenvironment, inhibiting two signaling pathways, affecting tumor cell growth

  • Additional data to be presented at Molecular Partners’ R&D Day in NYC on December 12, 2019

Zurich-Schlieren, Switzerland, December 7, 2019. Molecular Partners AG (SIX:MOLN), a clinical-stage biotech company pioneering the use of DARPin® therapeutics* to treat serious diseases, today announced a poster presentation at the American Society of Hematology 61st Annual Meeting in Orlando, FL, highlighting the activity of its tri-specific DARPin® drug candidate, MP0250, in patients undergoing treatment for multiple myeloma.

MP0250 is a first-in-class, tri-specific multi-DARPin® drug candidate neutralizing VEGF-A and HGF and is binding to human serum albumin to increase plasma half-life. The unique mechanism of action of MP0250 represents a new approach to targeting the tumor microenvironment and increase patients’ responses to already approved therapies for multiple myeloma, potentially even after progression.

“At present, anti-angiogenic agents are not part of treatment strategies in multiple myeloma, neither alone nor in combination with approved agents,” commented Nicolas Leupin, Chief Medical Officer of Molecular Partners. “MP0250 represents a unique and much-needed addition to the treatment paradigm for patients with multiple myeloma. We believe that by treating one of the underlying causes of the disease through targeting the tumor microenvironment, we can achieve durable and deep responses in patients relapsing after or refractory to treatment regimens including bortezomib, IMiDs or daratumumab. The response rate seen in this study, given the heavily pretreated patient population involved, is very encouraging. We look forward to the generation of additional combination data for MP0250 with relevant treatments to further detail the potential for this program.”

The full poster, titled “The MP0250-CP201 MiRRoR Study: A Phase 2 Study Update of MP0250 Plus Bortezomib and Dexamethasone in Relapsed/Refractory Multiple Myeloma (RRMM) Patients Previously Exposed to Proteasome Inhibitors and Immunomodulatory Drugs”, will be available for viewing in Exhibit Hall B from 5:30-7:30 p.m. EST on Saturday, December 7, 2019, and will be available at the company website, www.molecularpartners.com. A summary of the poster details are below:

• At the efficacy cut-off date of November 5, 2019, all 20 patients were evaluable for tumor response. One patient achieved a complete response (CR), three patients achieved very good partial responses (VGPR) and five patients achieved PRs, giving an ORR of 45%.

• All 20 patients had prior exposure to IMiDs and PIs and nine patients received PI-based regimens as their immediate prior line of therapy before the start of MP0250 + Vd. The median number of prior therapies was 4 (range 2-9).

• Importantly, six of nine patients who were either relapsed or refractory to a PI-based regimen prior to the triple combination achieved CR, VGPR or PR. Median duration of response for patients was 5 months (range 2-24 months). The patient with CR and two patients with VGPR have been on treatment for more than 9 months.

• Combining MP0250 at 8 mg/kg with standard doses of bortezomib and dexamethasone was generally well tolerated with discontinuation due to adverse events (AE) in only 15% of patients. No unexpected toxicity was observed and AEs reported were consistent with the toxicity profile of the individual agents.

Trial Design of MP0250-CP201 MiRRoR Study

The trial is recruiting adults ≥18 years of age with RRMM who have progressed after at least two prior treatment regimens, including bortezomib and an IMiD. Patients were enrolled to receive intravenous MP0250 on day 1 plus subcutaneous bortezomib 1.3 mg/m² on days 1, 4, 8, 11, oral dexamethasone 20 mg on days 1-2, 4-5, 8-9, 11-12 of each 21-day cycle. Patients will receive treatment until there is documented disease progression or unacceptable toxicity.

In addition to this poster presentation the company will highlight additional details from its MP0250 program, as well as the rest of its pipeline and discovery platform, at an R&D day to be held at the Yale Club in New York City on December 12th, 2019. To RSVP please contact Seth Lewis at seth.lewis@molecularpartners.com

Financial Calendar

December 12, 2019 R&D Day in New York City
February 6, 2020 Publication of Full-year Results 2019 (unaudited)
April 29, 2020 Annual General Meeting

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 can engage more than five targets, 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 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 in partnership with Allergan is abicipar, a molecule for which phase 3 data have been filed to the respective regulators in both the US and in Europe. Several DARPin® molecules for various ophthalmic indications are also in preclinical development. The most advanced DARPin® therapeutic candidate wholly owned by Molecular Partners, MP0250, is in phase 2 clinical development for the treatment of hematological tumors. MP0274, the second-most advanced DARPin® candidate owned by Molecular Partners, binds to Her2 and inhibits downstream signaling, which leads 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. The molecule has entered in phase 1 of clinical development 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 such as novel therapeutic designs to target peptide-MHC complexes. 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:

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

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

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

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.

INTERIM MANAGEMENT STATEMENT – Q3 2019: Encouraging Additional Phase 3 Data Presented for Abicipar, and Start of Phase 1 Trial for MP0310, the First Immuno-oncology DARPin® with a Novel Therapeutic Design

Research & Development:

  • MP0310 (FAP x 4-1BB): First patient dosed in phase 1 trial for this tumor-localized immune-modulator, representing a key milestone as the first novel therapeutic design of an immuno-oncology DARPin® candidate in clincial development (in co-development with Amgen)
  • MP0250 (VEGF x HGF) in Multiple Myeloma: Update on ongoing phase 2 PI trial (in combination with Velcade®) to be provided at ASH and company’s R&D Day in December 2019
  • Abicipar (VEGF):
    • FDA accepted Biologics License Application (BLA) and EMA validated Marketing Authorisation (MAA) in neovascular age-related macular degeneration (nAMD) in Q3 2019; U.S. launch, following FDA filing and review, expected mid-2020;
      EU approval expected in H2 2020
    • Encouraging two-year data from phase 3 studies in nAMD presented at AAO meeting in San Francisco; abicipar expected to be the first anti-VEGF therapy to sustain initial vision gains on a consistent 12-week dosing interval
  • Research: R&D Day on December 12, 2019 in New York City will underline the company’s continued progress and focus on novel therapeutic designs

Team:

  • Talent base with 133 full-time employees (+17% year-on-year), reflecting ongoing strong build-out of the organization, in both R&D and SG&A areas
  • Nicolas Leupin, M.D., MBA, started in his roles as Chief Medical Officer and Member of the Management Board effective September 1, 2019
  • Seth D. Lewis to join the company in November 2019 as Senior Vice President Investor Relations & Corporate Communications – Strategy, based in the company’s Boston-area office

Financial highlights:

  • Strong financial position with CHF 112.3 million in cash and short-term deposits
    as of September 30, 2019
  • FY 2019 expense guidance slightly reduced to CHF 55-60 million

 

Zurich-Schlieren, October 31, 2019. Molecular Partners AG (SIX: MOLN), a clinical-stage biotech company that is developing a new class of drugs known as DARPin® therapies*, announced today its Interim Management Statement for the period ending September 30, 2019.

“Abicipar represents the first DARPin® therapeutic to be accepted for review by FDA (U.S.) and EMA (EU), validating the potential of the DARPin® platform to yield candidates that fulfill all dimensions of development necessary for approval. We are convinced that the expected consistent 12-week dosing interval of Abicipar can bring benefit to patients,” said Patrick Amstutz, Ph.D., Chief Executive Officer of Molecular Partners. “Additionally, we are proud that MP0310, our first candidate from our suite of novel therapeutic design immuno-oncology molecules, has successfully entered the clinic. We are recruiting patients to evaluate MP0310’s ability to localize activation of the immune system to the tumor, potentially enabling higher anti-cancer activity without dose-limiting systemic side-effects.”

Oncology: Update of MP0250 in multiple myeloma to be presented in Q4 19

MP0250 is a multi-DARPin® candidate that targets hepatocyte growth factor (HGF) and vascular endothelial growth factor (VEGF), two prominent tumor escape pathways, and has the potential to reverse adaptive resistance to standard of care cancer therapies.

The first phase 2 trial for MP0250 in combination with proteasome inhibitors (PIs) is evaluating MP0250 in combination with bortezomib (Velcade®) and dexamethasone in patients with multiple myeloma who have failed standard therapies. The company will provide an update on the phase 2 trial data at both the ASH conference in Orlando and at the company’s R&D Day in New York City.

Immuno-oncology: Initiation of phase 1 trial of MP0310, a novel tumor-localized immunotherapy

For MP0310, also referred to by Amgen as AMG 506, the first patient has been enrolled and dosed in the first-in-human study of MP0310 as a single agent in patients with advanced solid tumors. The trial will evaluate the optimal dose range of MP0310 in preparation for planned combination studies with Amgen’s oncology pipeline products.

MP0310 is the first product candidate in Molecular Partners’ DARPin® immuno-oncology pipeline. It is designed to activate immune cells specifically in the tumor and not in the rest of the body, potentially delivering greater efficacy with fewer side effects. Preclinical studies of MP0310 have demonstrated immune T cell activation restricted to solid tumor tissues, and strong CD8 T cell activation and expansion in vitro and in vivo. Additionally, preclinical data show MP0310 does not induce strong systemic activation of CD8 T cells and, therefore, has lower risk of the systemic side effects and toxicities.

The MP0310-CP101 trial intends to enroll up to 54 patients at three sites in France. The open-label, dose-escalation study will evaluate the safety, tolerability and pharmacokinetics of MP0310 in patients with locally advanced or metastatic solid tumors.

Abicipar: Additional encouraging two-year data from phase 3 studies in nAMD presented at AAO

Allergan and Molecular Partners announced the two-year data from the CEDAR and SEQUOIA clinical studies of abicipar in patients with neovascular (wet) age-related macular degeneration (nAMD) at the annual meeting of the American Academy of Ophthalmology (AAO) in San Francisco. In the second year of these studies, quarterly-dosed of abicipar resulted in the maintenance of visual gains comparable to monthly-dosed ranibizumab (Lucentis®).

Through week 104, patients received 2 mg of abicipar every 8 weeks or every 12 weeks, or 0.5 mg of ranibizumab every 4 weeks. At week 104 in the pooled phase 3 data, the proportion of patients with stable vision was 93%, 90% and 94% in 8-week abicipar, 12-week abicipar and 4-week ranibizumab treatment regimens, respectively. This continuation of stable vision in the second year further reinforces the ability of abicipar to deliver effective outcomes with consistent quarterly dosing for the majority of patients.

Mean changes in best-corrected visual acuity (BCVA) seen in year two were similar when compared to year one across all treatment arms. Central retinal thickness (CRT) continued to decrease during year two when compared to year one. CRT for patients treated with abicipar dosed quarterly and every 8 weeks were similar to ranibizumab dosed every 4 weeks through week 104. Overall incidence rates of treatment-emergent adverse events at the end of year two were comparable between treatment groups. The pooled rate of new cases of intraocular inflammation in year two for patients who received abicipar in the 8- and 12-week arms was 1.9%, which is similar to the ranibizumab arm of 1%.

The data shown at AAO therefore reinforce a sustained response at two years with less frequent dosing of abicipar compared to standard of care therapy.

Abicipar: FDA accepted the BLA and EMA the MAA for patients with nAMD in Q3 2019, key milestones for the company and its DARPin® technology platform

In the third quarter 2019, the U.S. Food and Drug Administration (FDA) accepted a Biologics License Application (BLA) and the European Medicines Agency (EMA) validated a Marketing Authorisation Application (MAA) for abicipar pegol, a novel, investigational DARPin® therapy, in patients with neovascular (wet) age-related macular degeneration (nAMD). The FDA is expected to take action on the BLA mid-2020. A decision from the European Commission is expected in the second half of 2020.

The BLA and MAA filings are based on data from two phase 3 trials, CEDAR and SEQUOIA, which supported the non-inferior efficacy of the abicipar quarterly dosing regimen to maintain vision gains with more than 50 percent fewer injections versus ranibizumab (13 vs. 6) dosed monthly in the first year. The FDA filing acceptance marked an important milestone for the DARPin® technology as abicipar becomes our first DARPin® candidate to receive filing acceptance by the FDA.

Balance sheet: Strong cash and equity positions as of September 2019

Molecular Partners’ financial performance for the first nine months of 2019 reflects the cash collection in Q1 2019 of the USD 50 million upfront payment from Amgen for the MP0310 collaboration. Cash and short-term deposits increased by CHF 13.3 million over the first nine months of 2019 to CHF 112.3 million as of September 30, 2019 (June 30, 2019: CHF 123.3 million).

As of September 30, 2019, the company employed 133 FTEs, a 17% increase year-over-year, with approximately 85% of employees serving in R&D functions.

Business outlook and priorities

For the remainder of 2019, Molecular Partners will continue to advance its DARPin® candidates within its immuno-oncology research pipeline, specifically the FAP x CD40 molecule, the CD3 DARPin® T cell-engager platform as well as the peptide-MHC programs, and expects to present an update at the company’s R&D Day in New York City.

In immuno-oncology, recruitment of patients for the phase 1 trial of MP0310 (AMG 506) that is in collaboration with partner Amgen will continue in Q4 2019.

In oncology, the company expects to present additional data from its ongoing phase 2 trial of MP0250 in patients with multiple myeloma (MM) in combination with Velcade® in December 2019, both at the ASH conference as well as at the company’s R&D Day. The company further plans to present initial safety data for MP0274, the company’s proprietary DARPin® candidate for the treatment of HER2-positive cancer, in Q4 2019.

In ophthalmology, Molecular Partners continues to work closely with its partner Allergan in the preparation and education of the market for the expected market launch of abicipar in 2020. The FDA and EMA are currently reviewing the respective regulatory applications for abicipar in patients with nAMD. The FDA is expected to take action on the BLA in mid-2020. A decision from the European Commission is expected in the second half of 2020. Allergan further indicated its intention to launch the phase 3 study for abicipar in DME in 2020.

Financial outlook 2019

For the full year 2019, at constant exchange rates, the company trimmed the guidance for expected total expenses to CHF 55-60 million, of which around CHF 5 million will be non-cash effective costs for share-based payments, IFRS pension accounting and depreciations. This guidance reflects the discontinuation of the NSCLC trial for MP0250 as well as the reduced investment in manufacturing scale-up for phase 3 material trials for MP0250. Capital expenditures in FY 2019 are expected to be approximately CHF 2 million.

This guidance is subject to the progress of the pipeline, mainly driven by the speed of enrollment of patients in clinical trials, manufacturing costs, 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.

Financial Calendar

December 12, 2019 R&D Day in New York City
February 6, 2020 Publication of Full-year Results 2019 (unaudited)
April 29, 2020 Annual General Meeting

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 can engage more than five targets, 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 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 in partnership with Allergan is abicipar, a molecule for which phase 3 data have been filed to the respective regulators in both the US and in Europe,. Several DARPin® molecules for various ophthalmic indications are also in preclinical development. The most advanced DARPin® therapeutic candidate wholly owned by Molecular Partners, MP0250, is in phase 2 clinical development for the treatment of hematological tumors. MP0274, the second-most advanced DARPin® candidate owned by Molecular Partners, binds to Her2 and inhibits downstream signaling, which leads 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. The molecule has entered in phase 1 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 such as novel therapeutic desigens to target peptide-MHC comoplexes. 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

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.

Allergan and Molecular Partners Present Late-Breaking Data from Phase 3 Studies of Investigational Abicipar pegol in Neovascular Wet Age-Related Macular Degeneration

  •  Two-year results from CEDAR and SEQUOIA demonstrate that vision gains observed after one year with every 8-week and every 12-week dosing were maintained in the second year
  •  Abicipar sustained vision gains in year two with quarterly injections compared to monthly ranibizumab 
  • Reductions in central retinal thickness were lower in year two compared to year one for both quarterly and 8-week dosing arms of Abicipar and comparable to monthly ranibizumab
  • Data presented during Retina Subspecialty Day at American Academy of Ophthalmology Annual Meeting

 

DUBLIN, IRELAND – OCTOBER 11, 2019 – Allergan plc, (NYSE: AGN), a leading global pharmaceutical company with a more than 70-year heritage in ophthalmology and Molecular Partners (SIX: MOLN), a clinical-stage biopharmaceutical company developing a new class of drugs known as DARPin® therapies, today announced two-year data from the CEDAR and SEQUOIA clinical studies of investigational Abicipar in patients with neovascular (wet) age-related macular degeneration (nAMD). In the second year of these studies, four injections of Abicipar resulted in the maintenance of visual gains comparable to monthly ranibizumab.  These data were presented as a late-breaking oral presentation during Retina Subspecialty Day at the Annual Meeting of the American Academy of Ophthalmology (AAO).

CEDAR and SEQUOIA are identical global Phase 3 studies designed to assess the efficacy and safety of Abicipar 8-week and 12-week treatment regimens compared with monthly ranibizumab in treatment-naïve patients with nAMD.  Allergan previously announced that Abicipar met the prespecified primary end point of the proportion of patients with stable vision at week 52 demonstrating non-inferiority in both the 8-week and 12-week treatment regimens compared to monthly ranibizumab.

Through week 104, patients received Abicipar 2 mg every 8-weeks or every 12-weeks or ranibizumab 0.5 mg every 4 weeks.  At week 104 in the pooled Phase 3 data, the proportion of patients with stable vision was 93%, 90% and 94% in 8-week Abicipar; 12-week Abicipar and 4-week ranibizumab treatment regimens, respectively.  This continuation of stable vision in year 2 further reinforces the ability of Abicipar to deliver consistent quarterly dosing for the majority of patients.

“Current anti-VEGF treatments for neovascular age-related macular degeneration require frequent intravitreal injections,” said Rahul N. Khurana, M.D., Northern California Retina Vitreous Associates Medical Group. “Based on the results of CEDAR and SEQUOIA, which reinforce the efficacy of Abicipar while decreasing the number of injections, Abicipar could transform anti-VEGF treatment regimens.”

Mean changes in best-corrected visual acuity (BCVA) seen in year two were similar when compared to year one across all treatment arms. Central retinal thickness (CRT) continued to decrease during year two when compared to year one.  CRT for patients treated with Abicipar dosed quarterly and every 8-weeks were similar to ranibizumab dosed every 4 weeks through week 104. Overall incidence rates of treatment-emergent adverse events at the end of year two were comparable between treatment groups. The pooled rate of new cases of intraocular inflammation in year two for patients who received Abicipar in the 8-and 12-week arms was 1.9%, which is similar to the ranibizumab arm of 1%.

“These late-breaking data further demonstrate the potential of Abicipar to provide consistent quarterly dosing that sustains vision gains in the majority of patients with neovascular age-related macular degeneration,” said David Nicholson, Chief Research and Development Officer, Allergan. “On the heels of regulatory filings for Abicipar in the United States and European Union, these data give us confidence in our ability to meet a serious unmet need for patients and eye doctors.”

“We are very excited at the continued success of Abicipar, our most advanced DARPin® molecule, in the treatment of patients with neovascular age-related macular degeneration,” Patrick Amstutz, PhD, CEO of Molecular Partners. “We are pleased to see a sustained response at two-years with less frequent dosing of Abicipar compared to standard of care therapy.”

The U.S. Food and Drug Administration (FDA) and European Medicines Agency (EMA) are currently reviewing regulatory applications for Abicipar in patients with nAMD. The FDA is expected to take action on the BLA in mid-2020. A decision from the European Commission is expected in the second half of 2020.

 

About Allergan Eye Care

As a leader in eye care, Allergan has discovered, developed, and delivered some of the most innovative products in the industry for more than 70 years. Allergan has launched over 125 eye care products and invested billions of dollars in new treatments for the most prevalent eye conditions including glaucoma, ocular surface disease, and retinal diseases such as diabetic macular edema and retinal vein occlusion. Our eye care pipeline includes 13 additional agents for multiple ocular conditions.

Our commitment to the well-being of patients is also reflected in philanthropy. Allergan and The Allergan Foundation support more than 150 organizations around the world working to improve lives and communities. We remain steadfast in helping eye care providers deliver the best in patient care through innovative products and outreach programs.

 

About Allergan plc

Allergan plc (NYSE: AGN), headquartered in Dublin, Ireland, is a global pharmaceutical leader 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. As part of its approach to delivering innovation for better patient care, Allergan has built one of the broadest pharmaceutical and device research and development pipelines in the industry.

With colleagues and commercial operations located 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, PhD +1 (862) 261-7162

Media:

Lisa Brown, +1 (862) 261-7320

Lisa Kim, +1 (714) 246-3843

 

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 and Allergan’s Quarterly Report on Form 10-Q for the period ended June 30, 2019. 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 biopharmaceutical company that is developing a new class of therapies known as DARPin® therapies. 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 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

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.

Late-Stage Data from Abicipar in Age-Related Macular Degeneration to be Showcased at American Academy of Ophthalmology (AAO) Annual Meeting

Zurich-Schlieren, Switzerland, October 4, 2019. Molecular Partners AG (SIX: MOLN), a clinical-stage biotech company that is developing a new class of drugs known as DARPin® therapies*, today announced that its partner Allergan plc, (NYSE: AGN), a leading global pharmaceutical company with a more than 70-year heritage in ophthalmology, will present new data from investigational Abicipar at the Annual Meeting of the American Academy of Ophthalmology (AAO) to be held in San Francisco, California, as follows:

Retina Subspecialty Day, Late Breaking – RET 11 – Section VIII: Late Breaking Developments, Part I (Friday, October 11, 4:18 – 4:58 PM; local Pacific Time):

Abicipar for Neovascular Age‐related Macular Degeneration:
Two-Year Results from CEDAR and SEQUOIA Phase 3 Clinical Trials

  • Author: Khurana R.
  • Time: 4:34 – 4:39 PM, local Pacific Time

Financial Calendar

October 31, 2019 Interim Management Statement Q3 2019
December 12, 2019 R&D Day in New York
February 6, 2020 Publication of Full-year Results 2019 (unaudited)
April 29, 2020 Annual General Meeting

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

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

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 can engage more than five targets, 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 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 preclinical development. The most advanced DARPin® therapeutic candidate wholly owned by Molecular Partners, MP0250, is in phase 2 clinical development for the treatment of solid and hematological tumors. MP0274, the second-most advanced DARPin® candidate owned by Molecular Partners, binds to Her2 and inhibits downstream signaling, which leads 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

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 Announces First Patient Dosed in Phase 1 Trial of MP0310, a Novel Tumor-Localized Immunotherapy

Zurich-Schlieren, Switzerland, October 3, 2019. Molecular Partners AG (SIX: MOLN), a clinical-stage biotech company that is developing a new class of drugs known as DARPin® therapies*, today announced that the first patient has been enrolled and dosed in a Phase 1 first-in-human study of MP0310 as a single agent in patients with advanced solid tumors. The trial, entitled MP0310-CP101, will evaluate the optimal dose range of MP0310 in preparation for planned combination studies with Amgen’s oncology pipeline products.
MP0310 is the first product candidate in Molecular Partners’ DARPin® immuno-oncology pipeline. It is designed to activate immune cells specifically in the tumor and not in the rest of the body, potentially delivering greater efficacy with fewer side effects. Preclinical studies of MP0310 have demonstrated immune T cell activation restricted to solid tumor tissues, and strong CD8 T cell activation and expansion in vitro and in vivo. Additionally, preclinical data show MP0310 avoids strong systemic activation of CD8 T cells and, therefore, has lower risk of the systemic side effects and toxicities.

“We are delighted to have reached this important milestone in the development of our first immuno-oncology DARPin® therapeutic candidate. MP0310’s tumor-localized activation offers promising therapeutic potential both as a monotherapy and in combinations, where it may act to widen the therapeutic window of combination agents,” said Nicolas Leupin, M.D., Chief Medical Officer of Molecular Partners. “We look forward to the emerging clinical data and to progressing this therapy to patients in need.”
MP0310-CP101 intends to enroll up to 54 patients at three sites in France. The open-label, dose-escalation study will evaluate the safety, tolerability and pharmacokinetics of MP0310 administered as a single agent by intravenous (IV) infusion every three weeks (q3w) to patients with locally advanced or metastatic solid tumors. Patients will be treated until disease progression or trial discontinuation for any other reason.
“This is an important milestone as we jointly investigate MP0310 in preparation for future combinations with Amgen’s immuno-oncology pipeline products with the goal of bringing innovative immunotherapies to patients with cancer,” said Dirk Nagorsen, Vice President, Early Oncology Development, Amgen.

For more information, visit: https://clinicaltrials.gov/ct2/show/NCT04049903

Financial Calendar

October 31, 2019 Interim Management Statement Q3 2019
December 12, 2019 R&D Day in New York
February 6, 2020 Publication of Full-year Results 2019 (unaudited)
April 29, 2020 Annual General Meeting

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

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

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 can engage more than five targets, 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 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 preclinical development. The most advanced DARPin® therapeutic candidate wholly owned by Molecular Partners, MP0250, is in phase 2 clinical development for the treatment of solid and hematological tumors. MP0274, the second-most advanced DARPin® candidate owned by Molecular Partners, binds to Her2 and inhibits downstream signaling, which leads 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

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.

Allergan and Molecular Partners Announce Acceptance of U.S. FDA Biologics License Application and Validation of EMA Marketing Authorisation for Abicipar pegol in Patients with Neovascular (Wet) Age-related Macular Degeneration

  • Filing includes data from two Phase 3 trials which evaluated the safety and efficacy of Abicipar quarterly dosing regimen
  • Approvals in the United States and Europe are anticipated in 2020

DUBLIN, IRELAND – SEPT 9, 2019 – Allergan plc, (NYSE: AGN), a leading global pharmaceutical company with a heritage of more than 70 years in eye care, and Molecular Partners (SIX: MOLN), a clinical-stage biotechnology company developing a new class of drugs known as DARPin® platform, today announced that the U.S. Food and Drug Administration (FDA) has accepted a Biologics License Application (BLA) and the European Medicines Agency (EMA) has validated a Marketing Authorisation Application (MAA) for Abicipar pegol, a novel, investigational DARPin® therapy, in patients with neovascular (wet) age-related macular degeneration (nAMD). The FDA is expected to take action on the BLA mid-2020. A decision from the European Commission is expected in the second half of 2020.

The BLA and MAA filings are based on data from two Phase 3 trials, CEDAR and SEQUOIA, which supported the non-inferior efficacy of the Abicipar quarterly dosing regimen to maintain vision gains with more than 50 percent fewer injections versus ranibizumab (13 vs. 6) dosed monthly in the first year.

“Acceptance of our marketing applications brings us one step closer to offering physicians and patients a new treatment option that has the potential to reduce patient visits and injections while achieving and maintaining vision gains with quarterly dosing,” said David Nicholson, Chief Research and Development Officer, Allergan. “Today’s announcement reinforces Allergan’s continued commitment to eye care innovation and means patients are one step closer to receiving what we believe to be a transformative treatment that will help address unmet needs for nAMD patients.”

The identical, global Phase 3 head-to-head pivotal trials, CEDAR and SEQUOIA, assessed the efficacy and safety of Abicipar compared with ranibizumab in treatment-naïve patients with nAMD. The primary endpoint measured the proportion of treated patients with stable vision at week 52 and, in both studies, Abicipar demonstrated similar efficacy after 6 or 8 injections, compared to 13 ranibizumab injections in the first year of this study. The overall adverse events were similar among the three treatment arms (Abicipar dosed every 8 weeks, Abicipar dosed every 12 weeks, or ranibizumab dosed monthly).

“The FDA filing acceptance marks an important milestone for the DARPin® technology as Abicipar becomes our first DARPin® candidate to receive filing acceptance by the FDA,” commented Michael T. Stumpp, COO of Molecular Partners. “We’re excited for the potential Abicipar holds to become a true quarterly dosed anti-VEGF treatment in patients with nAMD to provide vision gains and improved quality of life.”

DARPin® molecules are derived from naturally occurring binding proteins that consist of repeat sequences with capping structures at each end of the protein. DARPin® molecules have three key properties that have made them an important investigational class of binding protein for researchers: high binding affinity, low molecular weight and customizable applications. These three properties make DARPin® molecules candidates for a broad range of therapeutic applications and are currently being investigated in therapeutic categories such as ophthalmology, oncology and immuno-oncology. Allergan and Molecular Partners are committed to advancing patient care through the development of molecules such as Abicipar.

About Allergan Eye Care

As a leader in eye care, Allergan has discovered, developed, and delivered some of the most innovative products in the industry for more than 70 years. Allergan has launched over 125 eye care products and invested billions of dollars in new treatments for the most prevalent eye conditions including glaucoma, ocular surface disease, and retinal diseases such as diabetic macular edema and retinal vein occlusion. Our eye care pipeline includes 13 additional agents for multiple ocular conditions.

Our commitment to the well-being of patients is also reflected in philanthropy. Allergan and The Allergan Foundation support more than 150 organizations around the world working to improve lives and communities. We remain steadfast in helping eye care providers deliver the best in patient care through innovative products and outreach programs.

About Allergan plc

Allergan plc (NYSE: AGN), headquartered in Dublin, Ireland, is a global pharmaceutical leader 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. As part of its approach to delivering innovation for better patient care, Allergan has built one of the broadest pharmaceutical and device research and development pipelines in the industry.

With colleagues and commercial operations located 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, PhD +1 (862) 261-7162

Media:

Lisa Brown, +1 (862) 261-7320

Lisa Kim, +1 (714) 246-3843

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 and Allergan’s Quarterly Report on Form 10-Q for the period ended June 30, 2019. 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 biopharmaceutical company that is developing a new class of therapies known as DARPin® therapies. 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 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

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.

Molecular Partners reports key financials for H1 19 and corporate highlights: EMA has validated the marketing authorization application for abicipar; Focus of MP0250 on multiple myeloma with expected initiation of ph2 IMiD trial in Q4 19; MP0310 ph1 start on track for H2 19

Research & Development:

  • MP0250 (VEGF x HGF) in MM: PI Trial (in combination with Velcade®) – Encouraging responses observed in first patient cohorts triggered decision for further investment;

    IMiD Trial (in combination with Pomalyst®) – Start of phase 2 trial expected in Q4 19, having received FDA approval

  • MP0250 in EGFR-mutated Non-Small Cell Lung Cancer (EGFR-mut NSCLC) in combination with Tagrisso®: Following lift of partial clinical hold by FDA, strategic decision to discontinue phase 2 trial and focus resources on MM trials

  • MP0274 (Her2): Phase 1 dose escalation trial in Her2-positive cancer patients progessing; first patients dosed at level of 4mg/kg

  • MP0310 (FAP x 4-1BB): Novel Therapeutic Design for tumor-localized immune-modulator on track to dose the first patient in the phase 1 trial in H2 19 (co-development with Amgen)

  • Research portfolio is focused on DARPin® candidates with innovative therapeutic designs, including tumor-localized FAP x CD40, peptide-MHC DARPin® binders and DARPin® T cell-engager candidates, and continues to progress according to plan

  • Abicipar (VEGF): EMA has validated marketing authorization application for abicipar; EMA decision may be received in H2 20; US launch, following FDA filing and review, expected mid-2020; abicipar expected to be the first anti-VEGF therapy to sustain initial vision gains on true fixed 12-week dosing interval

Team:

  • Molecular Partners appointed Nicolas Leupin, M.D., MBA, as Chief Medical Officer

  • Daniel Steiner, Ph.D., promoted to lead the company’s research department

  • 14% year-on-year increase of talent base to 128 full-time employees, reflecting ongoing build-out of research and clinical development expertise

Financial highlights:

  • Ongoing strong financial position with CHF 123.3 million in cash and short-term deposits as of June 30, 2019, ensuring financing into 2021, beyond the expected market launch of abicipar mid-2020

  • Net cash inflow from operating activities of CHF 27.0 million in H1 2019, positively reflecting the collection of the USD 50 million Amgen receivable in January 2019

  • FY 2019 expense guidance reiterated at CHF 60-70 million

 

Zurich-Schlieren, Switzerland, August 27, 2019. Molecular Partners AG (SIX: MOLN), a clinical-stage biotech company that is developing a new class of drugs known as DARPin® therapies*, today announced

its unaudited financial results for the first half-year 2019 and further corporate highlights. Over the course of recent months, the company has reported the EMA acceptance of the MAA filing for abicipar and an improved safety profile for the drug as shown in the MAPLE trial. Further encouraging data for MP0250 in multiple myeloma (MM) and substantial progress of the company’s research pipeline were reported.

“Molecular Partners today is highly focused on advancing DARPin® candidates with innovative therapeutic deigns to move the needle of medicine. As a result of the strategic decision to discontinue MP0250 in NSCLC following the observation of adverse events in this study, our focus for MP0250 is on MM, including a phase 2 trial to be started in combination with Pomalyst®. Further, we are on track to dose the first patient with MP0310. In our research pipeline, we are excited about the tangible progress advancing innovative therapeutic designs – specifically in the areas of tumor-localized immune-modulation, DARPin® T cell-engagers, and DARPin® candidates targeting peptide MHC complexes,” said Patrick Amstutz, Ph.D., Chief Executive Officer of Molecular Partners.

 

Oncology: Update of MP0250 in multiple myeloma

MP0250, Molecular Partners’ lead oncology asset, is a multi-DARPin® candidate that targets hepatocyte growth factor (HGF) and vascular endothelial growth factor (VEGF), two prominent tumor escape pathways, and has the potential to reverse adaptive resistance to standard of care cancer therapies. The first phase 2 study is evaluating MP0250 in combination with bortezomib (Velcade®), a proteasome inhibitors (PIs), and dexamethasone in patients with multiple myeloma who have failed standard therapies. Additional patient data presented in H1 2019 for this ongoing phase 2 study support previously observed response rates and duration of treatment.

Following the review by the FDA, the initiation of an additional phase 2 study for MP0250 in combination with Pomalidomide (Pomalyst®) in refractory multiple myeloma is on track to open recruitment in US and Europe in Q4 2019.

 

Clinical hold for MP0250 in Non-Small Cell Lung Cancer (NSCLC) lifted; strategic decision to discontinue the phase 2 trial

In May 2019, Molecular Partners suspended enrollment of new patients into the phase 1b/2 clinical study of MP0250 in combination with osimertinib (Tagrisso®) in patients with EGFR-mutated Non-Small Cell Lung Cancer (NSCLC) following the observation of a higher frequency of adverse events (nephrotic syndrome) in the kidney in this study leading to a partial clinical hold. Similar adverse events have also been observed for other anti-VEGF agents. In August 2019, the FDA has lifted the hold. However, the company has decided to prioritize multiple myeloma, where early clinical results have demonstrated the potential for MP0250 to play an important role for patients. As a result of this development, the company is redirecting its planned investment away from the NSCLC program.

 

MP0274 in HER2-positive solid tumors: Dose level of 4mg/kg reached

MP0274 is a multi-DARPin® product candidate in phase 1 evaluation for the treatment of HER2-positive solid tumors. Recruitment in the dose escalation phase continues and in July 2019 the first patients in the new dose cohort of 4mg/kg were dosed. Further updates on the safety profile of MP0274 are expected in H2 2019.

 

Immuno-oncology: MP0310 on-track to dose first patient in H2 2019

MP0310 is a DARPin® candidate testing a novel therapeutic design that locally activates immune cells in the tumor by binding to Fibroblast Activating Protein (FAP) on tumor stromal cells (localizer) and co-stimulating T-cells via 4‑1BB (immune modulator) clustering. In December 2018, Molecular Partners entered into a collaboration and license agreement with Amgen for the clinical development and commercialization of MP0310.

Having received all required regulatory approvals in Q2 2019, Molecular Partners is on-track to dose the first patient in H2 2019.

 

Research pipeline: Portfolio continues to make sustained progress with novel therapeutic designs, including localized FAP x CD40, peptide-MHC binders and DARPin® T cell-engager candidates

In March 2019, Molecular Partners and Gilead announced a collaboration exploring the potential of DARPin® molecules to selectively bind to peptide-MHC complexes. Peptide-MHC complexes provide a means to access the vast intracellular target space. However, to date, peptide-MHC complexes have been notoriously difficult to target with antibody-based therapeutics. Molecular Partners is evaluating whether DARPin® molecules provide a platform to selectively access this new therapeutic space in oncology.

Molecular Partners further presented additional preclinical data on the company’s immuno-oncology platform at the 2019 annual meeting of the American Association for Cancer Research (AACR) in Atlanta. 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.

Moreover, the company presented the first preclinical data on its novel CD3 T cell-engager platform based on DARPin® molecules. Initial data suggest that the company’s T cell-engaging DARPin® molecule matches antibody-based reference molecules in critical functional dimensions, has excellent biophysical properties and can be formatted with albumin binders for half-life extension.

 

Abicipar: EMA validated the marketing authorization application for abicipar; FDA feedback on acceptance of BLA filing pending

In August 2019, the European Medicines Agency (EMA) publicly announced that it has validated the marketing authorization application (MAA) for abicipar, Allergan and Molecular Partners’ novel DARPin® therapy for the treatment of neovascular age-related macular degeneration. An EMA decision on the market approval may be received in the second half of 2020. The US launch, following FDA filing and review, is expected mid-2020. If approved, abicipar is expected to be the first anti-VEGF therapy to sustain vision gains on a true fixed 12-week dosing interval.

On April 2, Allergan and Molecular Partners announced topline safety results from MAPLE, a 28-week open-label study which enrolled 123 patients and evaluated the safety of abicipar produced via a modified manufacturing process. As a result of the improvements in the manufacturing process, the incidence of intraocular inflammation (IOI) in the MAPLE study 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 more than halved to 1.6 percent. That reduction of the inflammation data shown in MAPLE is an important complement to the encouraging efficacy data from previously reported phase 3 trials. In those CEDAR and SEQUOIA trials, abicipar demonstrated its potential to transform the way physicians manage neovascular AMD with an anti-VEGF therapy. Clinical trial evidence has shown that fixed-interval dosing of anti-VEGF therapies administered either every month or every eight weeks results in better visual outcomes compared to real-world clinical outcomes. 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. A fixed-interval 12-week therapy would greatly reduce the treatment burden for patients with nAMD.

Additional data presented at the ARVO Conference in Vancouver on May 2, 2019 highlighted abicipar’s higher cumulative probability of achieving clearance of sub-retinal fluid, an absence of intra-retinal thickening, as well as an absence of all fluids compared to Lucentis®.

 

Nicolas Leupin, M.D., MBA, appointed new Chief Medical Officer

In August 2019, Molecular Partners appointed medical oncologist Nicolas Leupin, M.D., MBA, to the role of Chief Medical Officer and member of the Management Board effective September 1, 2019. Dr. Leupin succeeds Chief Medical Officer Andreas Harstrick, M.D. Following the transition in the coming months, it is expected that Andreas Harstrick continues to support the company’s medical strategy as an external consultant as required.

Dr. Leupin is a medical oncologist with a proven track record in drug development, most recently as Chief Medical Officer at argenx, a clinical-stage biotechnology company developing antibody-based therapies for the treatment of severe autoimmune diseases and cancer.

 

Daniel Steiner, Ph.D., promoted to lead the company’s research department

In June 2019, Molecular Partners announced a scientific leadership transition after a successful transformation of its research organization around a defined set of therapeutic strategies in oncology.

The company’s Senior Vice President of Research Daniel Steiner, Ph.D., was promoted to assume the leadership of the research department of the company, and Pamela A. Trail, Ph.D., departed from her role as Chief Scientific Officer effective July 1, 2019. Daniel Steiner joined Molecular Partners more than ten years ago and has held different roles within the company with increasing responsibilities.

 

Financial highlights: Positive operating cashflow reflects upfront payment collected from Amgen

In the first half of 2019, Molecular Partners recognized total revenues of CHF 13.6 million (H1 2018: CHF 9.4 million) and incurred operating expenses of CHF 26.0 million (H1 2018: CHF 22.1 million). This led to an operating loss of CHF 12.4 million for the first half-year 2019 which was broadly on par with the previous year’s level (H1 2018: operating loss of CHF 12.7 million). The company recognized a net financing loss of CHF 0.3 million (H1 2018: CHF 1.0 million income), mainly driven by FX effects on the USD, EUR and GBP cash positions. This resulted in a net loss of CHF 12.7 million for the first half-year 2019 (H1 2018: CHF 11.7 million).

Molecular Partners’ financial performance for the first half-year 2019 reflects the cash collection of the USD 50 million upfront payment from Amgen for the MP0310 collaboration. Cash and short-term deposits increased by CHF 24.3 million compared to year-end 2018 to CHF 123.3 million as of June 30, 2019. Total shareholders’ equity, at CHF 78.1 million as of June 30, 2019, decreased by CHF 13.6 millon (December 31, 2018: CHF 91.7 million).

As of June 30, 2019, the company employed 128 FTE, up 14% year-over-year. About 85% of the employees are employed in R&D-related functions.

Key figures as of June 30, 2019

Key Financials (unaudited) H1 2019 H1 2018 Change
(CHF million, except per share, FTE data)
Total revenues 13.6 9.4 4.2
R&D expenses -19.0 -17.7 -1.3
G&A expenses -7.0 -4.4 -2.6
Operating result -12.4  -12.7 0.3 
Net result -12.7  -11.7 -1.0
Basic net result per share (in CHF) -0.60 -0.56 -0.04
Net cash from (used in) operating activities 27.0 -19.4 46.4
Cash balance (incl. time deposits)
as of June 30
123.3  122.4 0.9 
Total shareholders’ equity
as of June 30
78.1 116.3 -38.2
Number of total FTE
as of June 30
127.7 112.3 15.4
– thereof in R&D 106.7 100.4 6.3
– thereof in G&A 21.0 11.9 9.1

“Our ongoing strong cash position provides us a cash runway into 2021. This implies a solid financial flexibility to achieve multiple value-creating inflection events, including the expected market launch of abicipar in 2020 and the related expected income stream from there on,” said Andreas Emmenegger, Chief Financial Officer of Molecular Partners.

Business outlook and priorities

In the second half of 2019, Molecular Partners will continue to advance its DARPin® candidates within its immuno-oncology research pipeline, specifically the FAP x CD40 molecule, the CD3 DARPin® T cell-engager platform as well as the peptide MHC program, and will present further research and preclinical data for additional therapeutic candidates resulting from the company’s immuno-oncology toolbox.

In immuno-oncology, Molecular Partners expects to start the clinical phase 1 trial for MP0310 that is in a collaboration with partner Amgen in H2 2019.

In oncology, the company expects to present additional data from its ongoing phase 2 trial of MP0250 in patients with multiple myeloma (MM) in combination with Velcade® (PI) in H2 2019. Molecular Partners also expects to start the phase 2 trial of MP0250 in combination with Pomalidomide® (IMiD) for the same indication. The company further plans to present initial safety data for MP0274, the company’s proprietary DARPin® candidate for the treatment of HER2-positive cancer, in H2 2019.

In ophthalmology, following EMA’s validation of the MAA filing for abicipar, a corresponding EMA decision may be received in the second half of 2020. The US launch, following FDA filing and review, is expected mid-2020. If approved, abicipar is expected to be the first anti-VEGF therapy to sustain vision gains on a true fixed 12-week dosing interval. Allergan is furthermore expected to present additional clinical data on the second year of the phase 3 trial in the second half of 2019.

Financial outlook 2019

For the full year 2019, at constant exchange rates, the company continues to expect total expenses of CHF 60-70 million, of which around CHF 6 million will be non-cash effective costs for share-based payments, IFRS pension accounting and depreciations. This guidance reflects the discontinuation of the NSCLC trial for MP0250 as well as the reduced investment in manufacturing scale-up for phase 3 material trials for MP0250. Capital expenditures in FY 2019 are expected to be approximately CHF 2 million.

This guidance is subject to the progress of the pipeline, mainly driven by the speed of enrollment of patients in clinical trials, manufacturing costs, 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.

Documentation

The results presentation, the press release and the half-year 2019 report will be available on www.molecularpartners.com from 7:00am (CET) on Tuesday, August 27, 2019.

Financial Calendar

October 31, 2019 Interim Management Statement Q3 2019
December 12, 2019 R&D Day in New York
February 6, 2020 Publication of Full-year Results 2019 (unaudited)
April 29, 2020 Annual General Meeting

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

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

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 can engage more than five targets, 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 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 preclinical development. The most advanced DARPin® therapeutic candidate wholly owned by Molecular Partners, MP0250, is in phase 2 clinical development for the treatment of solid and hematological tumors. MP0274, the second-most advanced DARPin® candidate owned by Molecular Partners, binds to Her2 and inhibits downstream signaling, which leads 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

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.