Molecular Partners Publishes Invitation to Annual General Meeting 2020

Molecular Partners Publishes Invitation to Annual General Meeting 2020

Zurich-Schlieren, Switzerland, March 25, 2020. Molecular Partners AG (SIX: MOLN), a clinical-stage biotech company that is developing a new class of drugs known as DARPin® therapies, today published the invitation to the Annual General Meeting 2020.

The Annual General Meeting will be held on Wednesday, April 29, 2020, 2.00 pm CET, at the registered office of the company:
Molecular Partners AG, Wagistrasse 14, 5th floor, 8952 Schlieren, Switzerland.

Based on Article 6a of Swiss Ordinance 2 on measures to fight the coronavirus (COVID-19) in the version from March 16, 2020, the Company has decided that shareholders of Molecular Partners AG may exercise their rights at the Annual General Meeting exclusively through the independent proxy. This measure allows the Company to hold the Annual General Meeting as planned despite the current situation. The conduct of the Annual General Meeting remains subject to additional measures issued by the Swiss authorities.

 

 

  • Invitation to the Annual General Meeting 2020 with the corresponding agenda items
  • Einladung zur Generalversammlung 2020 mit den zugehörigen Traktandenpunkten

Financial Calendar

April 29, 2020 Annual General Meeting
May 7, 2020 Interim Management Statement Q1 2020
August 26, 2020 Publication of Half-year Results 2020 (unaudited)
October 29, 2020 Interim Management Statement Q3 2020

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

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 79 40799522

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 Publishes Audited Financial Results for 2019 and Annual Report 2019

Zurich-Schlieren, Switzerland, March 20, 2020. Molecular Partners AG (SIX: MOLN), a clinical-stage biotech company that is developing a new class of drugs known as DARPin® therapies, today published its audited Financial Results for 2019 and the company’s 2019 Annual Report.

The Audited Financial Results for 2019 and the company’s 2019 Annual Report are available on the investors section of the company’s website.

Audited Key figures for FY 2019

(CHF million, except per share, FTE data)

FY 2019

FY 2018

change

Total revenues

20.4

10.4

10.0

R&D expenses

(43.5)

(38.2)

(5.3)

SG&A expenses

(13.5)

(9.6)

(3.9)

Operating result

(36.7)

(37.4)

0.7

Net financial result

0.4

0.4

0.0

Net result

(36.3)

(37.0)

0.7

Basic net result per share (in CHF)

(1.69)

(1.75)

0.06

Net cash from (used in) operating activities

(1.2)

(42.5)

41.3

Cash balance (incl. short-term deposits) as of Dec. 31

95.1

99.0

(3.9)

Total shareholders’ equity as of Dec. 31

54.1

91.7

(37.6)

Number of total FTE as of Dec. 31

135.2

117.7

17.5

Note: In completing the Annual Report the preliminary amounts for 2019 R&D expenses reported on February 6, 2020, have been reduced by approximately CHF 0.5 million.

Financial Calendar

April 29, 2020 Annual General Meeting
May 7, 2020 Interim Management Statement Q1 2020
August 26, 2020 Publication of Half-year Results 2020 (unaudited)
October 29, 2020 Interim Management Statement Q3 2020

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. MP0317 (FAP x CD40), the second tumor-localized immune agonist stemming from the company’s “I/O toolbox”, has been nominated as next DARPin® protein in Molecular Partners’ immuno-oncology pipeline. Molecular Partners is further advancing a growing preclinical and research pipeline in immuno-oncology 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 to Present at Two Upcoming Healthcare Investor Conferences

Zurich-Schlieren, Switzerland, February 24, 2020. 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 senior management will present at two upcoming healthcare investor conferences.

Conference Presentation Details:

  • Event: SVB Leerink 9th Annual Global Healthcare Conference
  • Date/Time: Wednesday, February 26, 2020 at 1:30 p.m. ET (7:30 p.m. CET)
  • Location: New York, NY

 

  • Event: Cowen & Co. 40th Annual Healthcare Conference
  • Date/Time: Tuesday, March 3, 2020 at 8:00 a.m. ET (2:00 p.m. CET)
  • Location: Boston, MA

 

A live webcast for the SVB Leerink and Cowen & Co. conference presentations may be accessed on the Investors/Media page of the Company’s website at www.molecularpartners.com. A replay of each webcast will be available shortly after the event on the Molecular Partners website.

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 Announces Newly Nominated Board Members for Upcoming Annual Meeting

  • Sandip Kapadia, Michael Vasconcelles and Vito J. Palombella nominated for election to the Board of Directors of Molecular Partners at the upcoming Annual General Meeting
  • Nominees bring extensive expertise in the fields of oncology drug discovery, translational science, clinical development, portfolio management, commercial product launch, and capital formation
  • Goran Ando, William Lee and Petri Vainio will not stand for re-election after 10 years or more on the Board of Directors

Zurich-Schlieren, Switzerland, February 20, 2020. Molecular Partners AG (SIX: MOLN), a clinical-stage biotech company that is developing a new class of drugs known as DARPin® therapies, today announced the nomination of three new board members, proposed for election at the 2020 Annual General Meeting on April 29, 2020.

Nominees are as follows:

  • Sandip Kapadia, Chief Financial Officer (CFO) of Intercept Pharmaceuticals
  • Michael Vasconcelles, M.D., Chief Medical Officer (CMO) of Flatiron Health
  • Vito J. Palombella, Ph.D., Chief Scientific Officer (CSO) of Surface Oncology

These nominees have been selected to coincide with the transition of three current members of the board, Goran Ando, William Lee and Petri Vainio. Each of these board members has dutifully served on the Molecular Partners board for 10 years or more and will not stand for re-election. The board’s new nominees are veteran U.S. biotech executives and experts in their respective fields, each of which deeply aligns with the current and future growth strategy of Molecular Partners and complements well with the rest of the board’s backgrounds and skills. Their collective experience in finance, business development, innovative clinical trial design, and early-stage drug discovery will be critical to Molecular Partners’ ongoing growth into a fully integrated oncology company with multiple assets in clinical development.

“I am extremely happy with the nominees proposed for election to the Board of Directors. Each of them possesses an expertise that will be essential as we continue to grow and accelerate our platform of novel therapeutic designs, prepare for our first potential product approval, and carefully evaluate how we invest our capital,” said Bill Burns, Chairman of the Board of Directors at Molecular Partners. “As we welcome these new nominees, I wish to extend my thanks to our outgoing board members. For more than ten years, Goran, Bill and Petri have been guiding hands to this company. Each of these individuals remains aligned with the vision of Molecular Partners, and I know that they will continue to support the company as individuals, and investors, well into the future. We wish them all the best in their future endeavors.”

Sandip Kapadia is currently CFO of Intercept Pharmaceuticals, a biopharmaceutical company focused on the development and commercialization of novel therapeutics to treat progressive non-viral liver diseases. He has over 20 years of experience in building and leading finance and administration teams at life sciences companies both in Europe and in the United States. Prior to joining Intercept, Sandip held finance leadership positions over 19 years at Novartis and Novartis affiliates in the United States, Switzerland, the Netherlands, and the United Kingdom, including CFO of North America at Novartis’s generic division, Sandoz. He was previously on the board of Therachon AG and has been serving on the Board of Directors for Passage Bio since January 2020. Sandip earned his bachelor’s degree in business administration and accounting from Montclair State University, an MBA from Rutgers Graduate School of Management and is a certified public accountant.

Michael Vasconcelles, M.D., is currently CMO of Flatiron Health, a healthcare technology and services company focused on accelerating cancer research and improving patient care. Prior to Flatiron, Michael served as CMO at Unum Therapeutics Inc., a Cambridge-based oncology biotech focused on developing autologous engineered T cell products for the treatment of cancer. Previously, Michael was accountable for the research and development strategy and execution of the oncology portfolio at both Takeda/Millennium and Genzyme, from discovery through product licensure and post-approval. Michael joined the faculty of the Harvard Medical School in 1996 and is currently a clinical instructor in medicine at Harvard Medical School and a practicing oncologist and associate physician at the Dana-Farber Cancer Institute and Brigham & Women’s Hospital in Boston.

Vito J. Palombella, Ph.D., is currently CSO of Surface Oncology, an immuno-oncology company developing next-generation antibody therapies focused on the tumor microenvironment, where he leads the company’s drug discovery and translational research efforts. Vito has over 25 years of scientific leadership and experience advancing first-in-class therapeutic programs. Prior to Surface, he was EVP and CSO at Infinity Pharmaceuticals, where he was responsible for drug discovery and preclinical development. Previously, he was director of molecular biology and protein chemistry at Syntonix Pharmaceuticals, senior director of cell and molecular biology at Millennium Pharmaceuticals, and held a number of positions at LeukoSite and ProScript. Vito was involved in the discovery and development of bortezomib (Velcade®), a proteasome inhibitor, and duvelisib (Copiktra®), a PI3K-d/g inhibitor, both for cancer therapy. Vito earned his bachelor’s degree in microbiology from Rutgers University and a master’s degree and doctorate degree in viral oncology and immunology from the New York University Medical Center.

Financial Calendar

March 20, 2020 Expected Publication of Annual Report 2019
April 29, 2020 Annual General Meeting
May 7, 2020 Interim Management Statement Q1 2020
August 26, 2020 Publication of Half-year Results 2020 (unaudited)
October 29, 2020 Interim Management Statement Q3 2020

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

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 reports key financials for FY 2019 and corporate highlights from Q4 2019

Molecular Partners reports key financials for FY 2019 and corporate highlights from Q4 2019

Research & Development:

  • Abicipar in Neovascular Wet Age-Related Macular Degeneration:
    • Two-year results from CEDAR and SEQUOIA presented at AAO in October 2019 demonstrate that vision gains observed after one year with both, every 8-week and every 12-week dosing were maintained in second year
    • FDA and EMA filings accepted and under review
  • MP0250 (VEGF x HGF) in Multiple Myeloma:
    • Updated data presented at ASH in December show long-lasting and deepening responses in patients with relapsed/refractory disease
    • U.S. FDA Orphan Drug Designation received in December 2019
    • Previously planned clinical trial investigating MP0250 in combination with an IMiD will not be initiated, in alignment with company’s corporate strategy to pursue combination data in collaboration with a partner
  • MP0310 / AMG 506 (FAP x 4-1BB): Dose escalation ongoing; current clinical timelines on track with additional clinical updates expected in H2 2020
  • MP0317 (FAP x CD40): Tumor-localized immune agonist nominated as second DARPin® protein in company’s immuno-oncology pipeline
  • Research: Progress continues on novel therapeutic designs including
    • tumor-localized immune-cell agonists,
    • peptide-MHC complex DARPin® binders, and
    • next-generation immune cell engagers

Financial Highlights:

  • Strong financial position with CHF 95.1 million in cash (incl. short-term deposits) as of December 31, 2019
  • Net cash used in operating activities of CHF 1.2 million in 2019 – Upfront free from Amgen (USD 50 million) reflected the majority of our investments into the pipeline
  • Operating loss of CHF 37.2 million and net loss of CHF 36.8 million in 2019
  • Company funded into H2 2021, one year beyond expected FDA decision regarding Abicipar
  • Talent base of 135 full-time employees at year-end 2019 (+15% year-on-year),
    reflective of growth of the company and its pipeline

 

Zurich-Schlieren, Switzerland, February 6, 2020. 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 2019 and corporate highlights for the fourth quarter 2019. The fourth quarter was marked by positive updated data on MP0250, refinement of the MP0250 development strategy, and noteworthy progress on the company’s pipeline of novel therapeutic designs.

“We have delivered on our commitment to constructing groundbreaking therapeutic designs and advancing them rapidly to patients. Both the initiation of our phase 1 trial for MP0310 and the nomination of MP0317 as our second immuno-oncology candidate have underscored the potential of our novel therapeutic designs,” said Patrick Amstutz, Ph.D., Chief Executive Officer of Molecular Partners. “As we embark on this new year, we look forward to FDA and EMA review of the regulatory submissions for abicipar, and working with our partner Allergan to deliver the first commercialized DARPin® therapeutic to patients with neovascular AMD.”

Abicipar: AAO Data highlight that vision gains were maintained throughout second year

In Q4 2019, two-year data from the CEDAR and SEQUOIA clinical studies of investigational Abicipar in patients with neovascular (wet) age-related macular degeneration (nAMD) were presented as a late-breaking oral presentation during Retina Subspecialty Day at the Annual Meeting of the American Academy of Ophthalmology (AAO). In the second year of these studies, four injections of Abicipar resulted in the maintenance of visual gains comparable 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.

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 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.

Oncology: Updated data and Orphan Drug Designation for MP0250 in multiple myeloma

Data presented at the 61st Annual Meeting of the American Society of Hematology (ASH) in December 2019 indicate that MP0250 continues to show long-lasting and deepening responses across a variety of patients with multiple myeloma in the relapsed/refractory setting. 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 improve sensitivity, or re-sensitize patients, to existing and emerging treatments.

The phase 2 trial for MP0250 in combination with bortezomib (Velcade®) and dexamethasone in patients with multiple myeloma who have failed standard therapies is ongoing. The company announced at its R&D Day in December 2019 its intent to evaluate partnering opportunities for MP0250. In conjunction with this endeavor, the company announced it 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. Additionally, the company announced in December 2019 that MP0250 has received Orphan Drug Designation by the U.S. Food and Drug Administration (FDA).

Immuno-oncology: Phase 1 trial of MP0310 continues dose escalation

For MP0310 (AMG 506), the phase 1 MP0310-CP101 trial is ongoing and dose escalation is underway. The trial expects to enroll up to 54 patients at three sites in France to evaluate the safety, tolerability and pharmacokinetics of MP0310 in patients with locally advanced or metastatic solid tumors. Current clinical timelines are on track; the trial is expected to expand into additional combination cohorts in H2 2020. These combination trials will be conducted by Amgen.

Immuno-oncology: MP0317 (FAP x CD40) nominated as next IND candidate stemming from the company’s immuno-oncology DARPin® toolbox

In Q4 2019, Molecular Partners nominated tumor-localized immune agonist MP0317 as the second DARPin® protein in the company’s immuno-oncology pipeline. MP0317 comprises localizer (FAP) and stimulator (CD40) DARPin® domains. 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 data demonstrated that the company’s multi-specific FAP x CD40 DARPin® molecule induced FAP-dependent activation of B cells, dendritic cells and macrophages.

Oncology: Dosing ongoing in trial for MP0274 in HER2-positive solid tumors

Recruitment for the phase 1 trial for MP0274 and the dose escalation phase continues. MP0274 is a multi-DARPin® product candidate being developed for the treatment of HER2-positive solid tumors. In preclinical trials MP0274 inhibits downstream signaling pathways, and directly kills HER2-addicted tumor cells through the induction of apoptosis. This represents a new and differentiated mode of action as compared to current standard of care antibodies.

Financial highlights: Net result and cash position on previous year’s level

In the financial year 2019, Molecular Partners recognized total revenues of CHF 20.4 million (2018: CHF 10.4 million) and incurred total expenses of CHF 57.6 million (2018: CHF 47.8 million). This led to an operating loss of CHF 37.2 million for 2019 (2018: Operating loss of CHF 37.4 million). The net financial result of CHF 0.4 million recorded in 2019 remained on the same level as in 2018. This resulted in a 2019 net loss of CHF 36.8 million (2018: Net loss of CHF 37.0 million).

The net cash used for operating activities in 2019 was CHF 1.2 million (2018: net cash used of CHF 42.5 million). Including time deposits, the cash and cash equivalents position decreased by CHF 3.9 million vs. year-end 2018 to CHF 95.1 million as of December 31, 2019 (December 31, 2018: CHF 99.0 million). Total shareholders’ equity stood at CHF 53.6 million as of December 31, 2019, a decrease of CHF 38.1 million (December 31, 2018: CHF 91.7 million).

Key figures as of December 31, 2019

Key Financials (unaudited)

FY 2019

FY 2018

change

(CHF million, except per share, FTE data)
Total revenues

20.4

10.4

10.0

R&D expenses

(44.0)

(38.2)

(5.8)

SG&A expenses

(13.5)

(9.6)

(3.9)

Operating result

(37.2)

(37.4)

0.2

Net financial result

0.4

0.4

0.0

Net result

(36.8)

(37.0)

0.2

Basic net result per share (in CHF)

(1.72)

(1.75)

0.03

Net cash from (used in) operating activities

(1.2)

(42.5)

41.3

Cash balance (incl. short-term deposits) as of Dec. 31

95.1

99.0

(3.9)

Total shareholders’ equity as of Dec. 31

53.6

91.7

(38.1)

Number of total FTE as of Dec. 31

135.2

117.7

17.5

As of December 31, 2019, the company employed 135 FTE, up 15% compared to year-end 2018. Approximately 85% of the employees are employed in R&D-related functions.

Business outlook and priorities

In 2020, Molecular Partners anticipates regulatory decisions by the FDA and EMA regarding the market launch of abicipar for patients with nAMD. The FDA is expected to take action on the BLA in mid-2020, and a decision from the European Commission is expected in the second half of 2020. Molecular Partners continues to work closely with its partner Allergan in the preparation and education of the market for the expected launch.

In immuno-oncology, recruitment of patients will continue in the phase 1 trial of MP0310 (AMG 506). Molecular Partners and Amgen expect to collect initial data from this trial in H2 2020.

In oncology, the company intends to continue to advance its phase 2 trial of MP0250 in patients with multiple myeloma in combination with Velcade® and will pursue partnership opportunities for the MP0250 program. The company further plans in 2020 to establish dosing and clinical strategy for MP0274, as that therapeutic candidate concludes its phase 1 dose escalation.

Additionally, Molecular Partners will continue to advance its immuno-oncology research pipeline, specifically the MP0317, the CD3 DARPin® T cell-engager platform and peptide-MHC programs.

Financial outlook 2020

For the FY 2020, at constant exchange rates, the company expects 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. The increase versus the previous year is driven by the progress of the company’s pipeline as well as the budgeted growth of the company’s workforce. Capital expenditures in FY 2020 are expected to be approximately CHF 3 million.

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

Investor documentation of FY 2019 results

This FY 2019 press release as well as the FY 2019 results presentation are available on the investors section of the company’s website.

FY 2019 results presentation, conference call and audio webcast

Molecular Partners will hold the FY 2019 results presentation in its headquarters in Zurich-Schlieren on February 06, 2020, 2:00pm CET (1:00pm GMT, 8:00am EST). For those who are unable to participate in the live event, the company provides conference call and audio webcast facilities.

In order to register for the FY 2019 conference call, please dial the following numbers approximately 10 minutes before the start of the presentation:

Switzerland / Europe +41 (0) 58 310 5000

UK +44 (0) 203 059 5862

USA +1 (1) 631 570 5613

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

Audio webcast

The FY19 results presentation 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

March 20, 2020 Expected Publication of Annual Report 2019
April 29, 2020 Annual General Meeting
May 7, 2020 Interim Management Statement Q1 2020
August 26, 2020 Publication of Half-year Results 2020 (unaudited)
October 29, 2020 Interim Management Statement Q3 2020

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. MP0317 (FAP x CD40), the second tumor-localized immune agonist stemming from the company’s “I/O toolbox”, has been nominated as next DARPin® protein in Molecular Partners’ immuno-oncology pipeline. Molecular Partners is further advancing a growing preclinical and research pipeline in immuno-oncology 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 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.