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

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

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

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

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

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

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

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

About Molecular Partners’ anti-COVID-19 program

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

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

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

About DARPin® therapeutics

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

About Molecular Partners AG

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

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

For further details, please contact:

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

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

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

Disclaimer

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

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

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

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

About Molecular Partners AG

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

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

For further details, please contact:

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

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

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

Disclaimer

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

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

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

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

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

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

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

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

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

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

About Molecular Partners’ anti-COVID-19 program

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

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

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

About DARPin® therapeutics

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

About AGC Biologics

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

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

Learn more at www.agcbio.com .

About Molecular Partners AG

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

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

For further details, please contact:

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

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

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

Disclaimer

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

Molecular Partners successfully completes Private Placement of 5,528,089 Shares by way of an Accelerated Bookbuilding

  • Proceeds from the Offering will help accelerate development of the SARS-CoV-2 antiviral candidate, MP0420, as well as early stage clinical and preclinical pipeline assets

Zurich-Schlieren, Switzerland, July 7, 2020. Molecular Partners AG (SIX: MOLN), a clinical-stage biotech company that is developing a new class of custom-built proteins known as DARPin® therapeutics, today announced that it has successfully placed 5,528,089 registered shares (the New Shares), corresponding to approximately 25% of the company’s currently registered share capital, by way of an accelerated bookbuilding process (the Offering), at an offering price of CHF 14.50 per share. The gross proceeds of the Offering, before deducting commissions and offering expenses, amount to approximately CHF 80.2 million (~USD 85.1 million). The offering included participation by new and existing institutional investors in Switzerland, the United States and the European Union, including Suvretta Capital Management, LLC, Camber Capital Management LP, BVF Partners L.P., Federated Hermes Kaufmann Funds and Monashee Investment Management LLC.

The New Shares will be issued from existing authorized share capital of the company under exclusion of the existing shareholders’ pre-emptive rights.

SVB Leerink LLC, Cowen and Company, LLC, Credit Suisse AG and Van Lanschot Kempen Wealth Management N.V. acted as Joint Bookrunners. HC Wainwright & Co.  and Octavian AG served as Financial Advisors.

The New Shares are expected to be listed and admitted to trading on SIX Swiss Exchange as of July 9, 2020. Payment and settlement is expected to take place on the same date. Molecular Partners AG intends to use the net proceeds from the Offering to fund R&D activities, in particular to accelerate
its early stage pipeline, as well as for general corporate purposes.

The company, members of the board of directors and members of the management board have agreed to a 90-day lock-up period after settlement of the New Shares, subject to certain customary exceptions.

The New Shares were offered exclusively to (a) professional investors in Switzerland on the basis of applicable exemptions from the prospectus requirements under the Swiss Financial Services Act and outside of the United States in compliance with Regulation S under the U.S. Securities Act of 1933, as amended (the U.S. Securities Act), (b) certain qualifying investors outside of Switzerland and outside of the United States by way of private offerings in reliance on Regulation S under the U.S. Securities Act and exemptions from prospectus, registration and/or filing requirements available under local securities laws and (c) a limited number of persons within the United States who are reasonably believed to be qualified institutional buyers in a private placement pursuant to Section 4(a)(2) of the U.S. Securities Act or pursuant to another exemption from, or in a transaction not subject to, the registration requirements of the U.S. Securities Act.

About Molecular Partners AG

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

For further details, please contact:

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

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

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

Disclaimer

THIS PRESS RELEASE IS NOT AN OFFER OF SECURITIES FOR SALE IN THE UNITED STATES AND THE SECURITIES REFERRED TO HEREIN MAY NOT BE OFFERED OR SOLD IN THE UNITED STATES ABSENT REGISTRATION EXCEPT PURSUANT TO AN EXEMPTION FROM, OR IN A TRANSACTION NOT SUBJECT TO, THE REGISTRATION REQUIREMENTS OF THE U.S. SECURITIES ACT; ANY PUBLIC OFFERING OF SUCH SECURITIES TO BE MADE IN THE UNITED STATES WILL BE MADE BY MEANS OF A PROSPECTUS THAT MAY BE OBTAINED FROM THE ISSUER, WHICH WOULD CONTAIN DETAILED INFORMATION ABOUT THE COMPANY AND MANAGEMENT, AS WELL AS FINANCIAL STATEMENTS.

THIS PRESS RELEASE IS NOT A PROSPECTUS AND IS NOT INTENDED TO CONSTITUTE OR FORM A PART OF ANY OFFER OR SOLICITATION TO PURCHASE OR SUBSCRIBE FOR SECURITIES IN, AND IS NOT FOR RELEASE, PUBLICATION OR DISTRIBUTION IN WHOLE OR IN PART IN OR INTO, THE UNITED STATES, CANADA, JAPAN OR AUSTRALIA, EXCEPT AS PERMITTED BY APPLICABLE LAW. THERE WILL BE NO PUBLIC OFFERING OF ANY OF THE COMPANY’S SECURITIES IN THE UNITED STATES OR IN ANY OTHER JURISDICTION. INVESTORS SHOULD NOT PURCHASE ANY SECURITIES REFERRED TO IN THIS PRESS RELEASE ON THE BASIS OF THE INFORMATION CONTAINED HEREIN.

THIS PRESS RELEASE DOES NOT PURPORT TO IDENTIFY OR SUGGEST THE RISKS (DIRECT OR INDIRECT) WHICH MAY BE ASSOCIATED WITH AN INVESTMENT IN THE COMPANY AND THE COMPANY’S SECURITIES. THE INFORMATION IN THIS PRESS RELEASE IS SUBJECT TO CHANGE. NO OBLIGATION IS UNDERTAKEN TO UPDATE THIS PRESS RELEASE OR CORRECT ANY INACCURACIES, AND THE DISTRIBUTION OF THIS PRESS RELEASE SHALL NOT BE DEEMED TO BE ANY FORM OF COMMITMENT ON THE PART OF THE COMPANY TO PROCEED WITH ANY TRANSACTION OR ARRANGEMENT REFERRED TO HEREIN. THIS PRESS RELEASE HAS NOT BEEN APPROVED BY ANY COMPETENT REGULATORY AUTHORITY.

The offer referred to herein, when made in member states of the European Economic Area (EEA) and the United Kingdom, is only addressed to and directed to “qualified investors” within the meaning of Article 2(e) the Prospectus Regulation (Qualified Investors). For these purposes, the expression Prospectus Regulation means Regulation (EU) 2017/1129 of the European Parliament and of the Council of June 14 2017 on the prospectus to be published when securities are offered to the public or admitted to trading on a regulated market, and repealing Directive 2003/71/EC, and includes any relevant delegated regulations.

If located in a relevant state, each person who initially acquires any securities, and to the extent applicable any funds on behalf of which such person acquires such securities that are located in a relevant state, or to whom any offer of securities may be made will be deemed to have represented, acknowledged and agreed that it is a Qualified Investor as defined above.

The offer of the securities referred to herein will be made pursuant to exemptions under the Prospectus Regulation from the requirement to produce a prospectus in connection with offers of securities.

For readers in the United Kingdom, this press release is only being distributed to and is only directed at Qualified Investors who are (i) outside the United Kingdom or (ii) investment professionals falling within Article 19(5) (Investment professionals) of the Financial Services and Markets Act 2000 (Financial Promotion) Order 2005 (the Order) or (iii) certain high value persons and entities who fall within Article 49(2)(a) to (d) (“High net worth companies, unincorporated associations etc.”) of the Order; or (iv) any other person to whom it may lawfully be communicated (all such persons in (i) to (iv) together being referred to as relevant persons). The New Shares are expected to only be available to, and any invitation, offer or agreement to subscribe, purchase or otherwise acquire such New Shares will be engaged in only with, relevant persons. Any person who is not a relevant person should not act or rely on this announcement or any of its contents.

The offering of the shares in Switzerland is exempt from the requirement to prepare and publish a prospectus under the Swiss Financial Services Act (FinSA) because such offering is made to professional clients within the meaning of the FinSA only. This press release does not constitute a prospectus as such term is understood pursuant to the FinSA, the Swiss Code of Obligations in its version as it was effective immediately prior to the entering into force of the FinSA or pursuant to the listing rules of any stock exchange or regulated trading venue in Switzerland.

This press release does not constitute or form part of, and should not be construed as an offer or the solicitation of an offer to subscribe for or purchase the New Shares, and nothing contained therein shall form the basis of or be relied on in connection with any contract or commitment whatsoever, nor does it constitute a recommendation regarding the New Shares. An investment decision to buy any of the New Shares must be made solely on the basis of publicly available information. Such information is not the responsibility of, and has not been independently verified by, SVB Leerink LLC, Cowen and Company, LLC, Credit Suisse AG or Van Lanschot Kempen Wealth Management N.V. or any of their respective affiliates (the Managers). The Managers are acting only for the company in connection with the Offering and no one else. They will not regard any other person as their respective clients in relation to the Offering and will not be responsible to anyone other than the company for providing the protections afforded to their respective clients, nor for providing advice in relation to the Offering, the contents of this announcement or any transaction, arrangement or other matter referred to herein. No representation or warranty, express or implied, is or will be made as to, or in relation to, and no responsibility or liability is or will be accepted by the Managers as to or in relation to the accuracy or completeness of this announcement or any other written or oral information made available to or publicly available to any interested party or its advisers, and any liability therefore is expressly disclaimed.

Forward-looking statements

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

 

Molecular Partners announces the launch of a Private Placement of Shares by way of an Accelerated Bookbuilding

  • Proceeds used to accelerate early stage pipeline, inclusive of MP0310, MP0317 and the SARS-CoV-2 antiviral program MP0420

Zurich-Schlieren, Switzerland, July 6, 2020. Molecular Partners AG (SIX: MOLN), a clinical-stage biotech company that is developing a new class of custom-built protein therapeutics known as DARPin® therapeutics, today announced the launch of a private placement of up to approximately 5.5 million newly issued shares with a nominal value of CHF 0.10 each (the Offered Shares), to be issued from existing authorized share capital of the company under exclusion of the existing shareholders’ pre-emptive rights by way of an accelerated bookbuilding (the Offering).

The offer price will be determined through an accelerated bookbuilding process (the Bookbuilding) which starts immediately and the Offered Shares will be offered exclusively to (a) professional investors in Switzerland on the basis of applicable exemptions from the prospectus requirements under the Swiss Financial Services Act and outside of the United States in compliance with Regulation S under the U.S. Securities Act of 1933, as amended (the U.S. Securities Act), (b) certain qualifying investors outside of Switzerland and outside of the United States by way of private offerings in reliance on Regulation S under the U.S. Securities Act and exemptions from prospectus, registration and/or filing requirements available under local securities laws and (c) a limited number of persons within the United States who are reasonably believed to be qualified institutional buyers in a private placement pursuant to Section 4(a)(2) of the U.S. Securities Act or pursuant to another exemption from, or in a transaction not subject to, the registration requirements of the U.S. Securities Act.

The offer price of the Offered Shares and the final number of shares will be announced upon completion of the Bookbuilding, which is expected prior to market opening on July 7, 2020.

As a result of the capital increase and assuming all Offered Shares are placed, Molecular Partners AG’s registered share capital will increase by approximately 25% from CHF 2,160,119.20 to CHF 2,712,928.10, divided into 27,129,281 registered shares with a nominal value of CHF 0.10 each. Molecular Partners AG intends to use the net proceeds from the Offering to fund R&D activities as well as for general corporate purposes.

The Offered Shares, if issued, are expected to be listed and admitted to trading on SIX Swiss Exchange as of July 9, 2020. Payment and settlement is expected to take place on the same date. The Offered Shares will rank pari passu with the existing shares.

The company, members of the board of directors and members of the management board have agreed to a 90-day lock-up period after settlement of the Offered Shares, subject to certain customary exceptions.

SVB Leerink LLC, Cowen and Company, LLC, Credit Suisse AG and Van Lanschot Kempen Wealth Management N.V. are acting as Joint Bookrunners.

About Molecular Partners AG

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

For further details, please contact:

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

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

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

Disclaimer

THIS PRESS RELEASE IS NOT AN OFFER OF SECURITIES FOR SALE IN THE UNITED STATES AND THE SECURITIES REFERRED TO HEREIN MAY NOT BE OFFERED OR SOLD IN THE UNITED STATES ABSENT REGISTRATION EXCEPT PURSUANT TO AN EXEMPTION FROM, OR IN A TRANSACTION NOT SUBJECT TO, THE REGISTRATION REQUIREMENTS OF THE U.S. SECURITIES ACT; ANY PUBLIC OFFERING OF SUCH SECURITIES TO BE MADE IN THE UNITED STATES WILL BE MADE BY MEANS OF A PROSPECTUS THAT MAY BE OBTAINED FROM THE ISSUER, WHICH WOULD CONTAIN DETAILED INFORMATION ABOUT THE COMPANY AND MANAGEMENT, AS WELL AS FINANCIAL STATEMENTS.

THIS PRESS RELEASE IS NOT A PROSPECTUS AND IS NOT INTENDED TO CONSTITUTE OR FORM A PART OF ANY OFFER OR SOLICITATION TO PURCHASE OR SUBSCRIBE FOR SECURITIES IN, AND IS NOT FOR RELEASE, PUBLICATION OR DISTRIBUTION IN WHOLE OR IN PART IN OR INTO, THE UNITED STATES, CANADA, JAPAN OR AUSTRALIA, EXCEPT AS PERMITTED BY APPLICABLE LAW. THERE WILL BE NO PUBLIC OFFERING OF ANY OF THE COMPANY’S SECURITIES IN THE UNITED STATES OR IN ANY OTHER JURISDICTION. INVESTORS SHOULD NOT PURCHASE ANY SECURITIES REFERRED TO IN THIS PRESS RELEASE ON THE BASIS OF THE INFORMATION CONTAINED HEREIN.

THIS PRESS RELEASE DOES NOT PURPORT TO IDENTIFY OR SUGGEST THE RISKS (DIRECT OR INDIRECT) WHICH MAY BE ASSOCIATED WITH AN INVESTMENT IN THE COMPANY AND THE COMPANY’S SECURITIES. THE INFORMATION IN THIS PRESS RELEASE IS SUBJECT TO CHANGE. NO OBLIGATION IS UNDERTAKEN TO UPDATE THIS PRESS RELEASE OR CORRECT ANY INACCURACIES, AND THE DISTRIBUTION OF THIS PRESS RELEASE SHALL NOT BE DEEMED TO BE ANY FORM OF COMMITMENT ON THE PART OF THE COMPANY TO PROCEED WITH ANY TRANSACTION OR ARRANGEMENT REFERRED TO HEREIN. THIS PRESS RELEASE HAS NOT BEEN APPROVED BY ANY COMPETENT REGULATORY AUTHORITY.

The offer referred to herein, when made in member states of the European Economic Area (EEA) and the United Kingdom, is only addressed to and directed to “qualified investors” within the meaning of Article 2(e) the Prospectus Regulation (Qualified Investors). For these purposes, the expression Prospectus Regulation means Regulation (EU) 2017/1129 of the European Parliament and of the Council of June 14 2017 on the prospectus to be published when securities are offered to the public or admitted to trading on a regulated market, and repealing Directive 2003/71/EC, and includes any relevant delegated regulations.

If located in a relevant state, each person who initially acquires any securities, and to the extent applicable any funds on behalf of which such person acquires such securities that are located in a relevant state, or to whom any offer of securities may be made will be deemed to have represented, acknowledged and agreed that it is a Qualified Investor as defined above.

The offer of the securities referred to herein will be made pursuant to exemptions under the Prospectus Regulation from the requirement to produce a prospectus in connection with offers of securities.

For readers in the United Kingdom, this press release is only being distributed to and is only directed at Qualified Investors who are (i) outside the United Kingdom or (ii) investment professionals falling within Article 19(5) (Investment professionals) of the Financial Services and Markets Act 2000 (Financial Promotion) Order 2005 (the Order) or (iii) certain high value persons and entities who fall within Article 49(2)(a) to (d) (“High net worth companies, unincorporated associations etc.”) of the Order; or (iv) any other person to whom it may lawfully be communicated (all such persons in (i) to (iv) together being referred to as relevant persons). The Offered Shares are expected to only be available to, and any invitation, offer or agreement to subscribe, purchase or otherwise acquire such Offered Shares will be engaged in only with, relevant persons. Any person who is not a relevant person should not act or rely on this announcement or any of its contents.

The offering of the shares in Switzerland is exempt from the requirement to prepare and publish a prospectus under the Swiss Financial Services Act (FinSA) because such offering is made to professional clients within the meaning of the FinSA only. This press release does not constitute a prospectus as such term is understood pursuant to the FinSA, the Swiss Code of Obligations in its version as it was effective immediately prior to the entering into force of the FinSA or pursuant to the listing rules of any stock exchange or regulated trading venue in Switzerland.

This press release does not constitute or form part of, and should not be construed as an offer or the solicitation of an offer to subscribe for or purchase the Offered Shares, and nothing contained therein shall form the basis of or be relied on in connection with any contract or commitment whatsoever, nor does it constitute a recommendation regarding the Offered Shares. An investment decision to buy any of the Offered Shares must be made solely on the basis of publicly available information. Such information is not the responsibility of, and has not been independently verified by, SVB Leerink LLC, Cowen and Company, LLC, Credit Suisse AG or Van Lanschot Kempen Wealth Management N.V. or any of their respective affiliates (the Managers). The Managers are acting only for the company in connection with the Offering and no one else. They will not regard any other person as their respective clients in relation to the Offering and will not be responsible to anyone other than the company for providing the protections afforded to their respective clients, nor for providing advice in relation to the Offering, the contents of this announcement or any transaction, arrangement or other matter referred to herein. No representation or warranty, express or implied, is or will be made as to, or in relation to, and no responsibility or liability is or will be accepted by the Managers as to or in relation to the accuracy or completeness of this announcement or any other written or oral information made available to or publicly available to any interested party or its advisers, and any liability therefore is expressly disclaimed.

Information to Distributors

Solely for the purposes of the product governance requirements of EU Directive 2014/65/EU on markets in financial instruments, as amended (MiFID II); (b) Articles 9 and 10 of Commission Delegated Directive (EU) 2017/593 supplementing MiFID II; and (c) local implementing measures (together, the MiFID II Product Governance Requirements), and disclaiming all and any liability, whether arising in tort, contract or otherwise, which any “manufacturer” (for the purposes of the MiFID II Product Governance Requirements) may otherwise have with respect thereto, the securities the subject of the offering described herein have been subject to a product approval process, which has determined that such securities are: (i) compatible with an end target market of retail investors and investors who meet the criteria of professional clients and eligible counterparties, each as defined in MiFID II; and (ii) eligible for distribution through all distribution channels as are permitted by MiFID II (the Target Market Assessment). Notwithstanding the Target Market Assessment, distributors should note that: the price of the securities may decline and investors could lose all or part of their investment; the securities offer no guaranteed income and no capital protection; and an investment in the securities is compatible only with investors who do not need a guaranteed income or capital protection, who (either alone or in conjunction with an appropriate financial or other adviser) are capable of evaluating the merits and risks of such an investment and who have sufficient resources to be able to bear any losses that may result therefrom. The Target Market Assessment is without prejudice to the requirements of any contractual, legal or regulatory selling restrictions in relation to the offering. Furthermore, it is noted that, notwithstanding the Target Market Assessment, the Managers will only procure investors who meet the criteria of professional clients and eligible counterparties. For the avoidance of doubt, the Target Market Assessment does not constitute: (a) an assessment of suitability or appropriateness for the purposes of MiFID II; or (b) a recommendation to any investor or group of investors to invest in, or purchase, or take any other action whatsoever with respect to the securities.

Each distributor is responsible for undertaking its own target market assessment in respect of the securities and determining appropriate distribution channels.

Forward-looking statements

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

 

Allergan, an AbbVie Company, and Molecular Partners Receive Complete Response Letter from FDA on Biologics License Application for Abicipar pegol

NORTH CHICAGO, Ill., June 26, 2020  – Allergan, an AbbVie Company (NYSE: ABBV), and Molecular Partners (SIX: MOLN), a clinical-stage biotechnology company developing a new class of custom-built protein therapeutics known as DARPin® therapeutics, today announced that the U.S. Food and Drug Administration (FDA) has issued a Complete Response Letter to the Biologics License Application (BLA) for Abicipar pegol, a novel, investigational DARPin® therapy for patients with neovascular (wet) age-related macular degeneration (nAMD).

The letter from the FDA indicates that the rate of intraocular inflammation observed following administration of Abicipar pegol 2mg/0.05 mL results in an unfavorable benefit-risk ratio in the treatment of neovascular (wet) age-related macular degeneration (AMD). AbbVie plans to meet with the FDA to discuss their comments and determine next steps.

“We continue to believe in the need for treatment options that provide patients with reliable vision gains and less frequent dosing for the treatment of nAMD,” said Michael R. Robinson, M.D., Vice President, Global Therapeutic Area Head, Ophthalmology, AbbVie. “We are committed to working with the FDA to determine the appropriate next steps for Abicipar pegol.”

The global need for eye health services is projected to increase dramatically in the coming decades, posing a considerable challenge to healthcare systems. Through building a strong, active pipeline, which is focused on significant unmet needs in eye care, AbbVie is committed to developing and delivering sustainable solutions that make a remarkable impact on people’s lives.

About DARPin® Molecules

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 over a dozen additional agents for multiple ocular conditions.

We remain steadfast in helping eye care providers deliver the best in patient care through innovative products and outreach programs. 

About AbbVie

AbbVie’s mission is to discover and deliver innovative medicines that solve serious health issues today and address the medical challenges of tomorrow. We strive to have a remarkable impact on people’s lives across several key therapeutic areas: immunology, oncology, neuroscience, eye care, virology, women’s health and gastroenterology, in addition to products and services across its Allergan Aesthetics portfolio. For more information about AbbVie, please visit us at www.abbvie.com. Follow @abbvie on Twitter, Facebook, Instagram, YouTube and LinkedIn.

About Molecular Partners AG

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

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

AbbVie contacts:

Lisa Kim, U.S. Media
Tel: +1 (714) 246-3843

Liz Shea, Investors
Tel: +1 (847) 935-2211

Molecular Partners contacts:

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

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

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

Forward-Looking Statements

Some statements in this news release are, or may be considered, forward-looking statements for purposes of the Private Securities Litigation Reform Act of 1995. The words “believe,” “expect,” “anticipate,” “project” and similar expressions, among others, generally identify forward-looking statements. AbbVie cautions that these forward-looking statements are subject to risks and uncertainties that may cause actual results to differ materially from those indicated in the forward-looking statements. Such risks and uncertainties include, but are not limited to, failure to realize the expected benefits from AbbVie’s acquisition of Allergan plc (“Allergan”), failure to promptly and effectively integrate Allergan’s businesses, competition from other products, challenges to intellectual property, difficulties inherent in the research and development process, adverse litigation or government action, changes to laws and regulations applicable to our industry and the impact of public health outbreaks, epidemics or pandemics, such as COVID-19. Additional information about the economic, competitive, governmental, technological and other factors that may affect AbbVie’s operations is set forth in Item 1A, “Risk Factors,” of AbbVie’s 2019 Annual Report on Form 10-K, which has been filed with the Securities and Exchange Commission, as updated by its subsequent Quarterly Reports on Form 10-Q. AbbVie undertakes no obligation to release publicly any revisions to forward-looking statements as a result of subsequent events or developments, except as required by law.

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 Preclinical Data from MP0317, AMG 506 / MP0310 and Peptide-MHC Programs at AACR Annual Meeting

Zurich-Schlieren, Switzerland, May 15, 2020. Molecular Partners AG (SIX: MOLN), a clinical-stage biotech company that is developing a new class of custom-built protein therapeutics known as DARPin® therapeutics, today announced the presentation of preclinical data from three of the company’s programs at the American Academy for Cancer Research (AACR) Virtual Annual Meeting II, June 22-24, 2020.

Data to be presented on MP0317 (FAP x CD40) include in vitro and in vivo experiments which show that MP0317 displays significant tumor-localized immune activation without systemic toxicity seen with anti-CD40 antibody administration. In human B cells and dendritic cells, MP0317 was found to activate the CD40 pathway solely in the presence of fibroblast activation protein (FAP)-positive cells, confirming its strict dependence on FAP-mediated crosslinking. In a mouse model, a mouse-specific FAP x CD40 DARPin® molecule was found to substantially inhibit the progression of FAP-positive tumors without showing any of the toxicities seen with administration of a mouse CD40 antibody. FAP is a tumor-associated antigen abundantly expressed in many solid tumors, which Molecular Partners is leveraging to co-locate MP0317 to its target tissues.

Data to be presented on the peptide-MHC DARPin® program review the creation of bispecific DARPin® T cell engager proteins that bind with high specificity to a HLA-A2: SLL peptide-MHC complex. The constructed DARPin® proteins were observed to effectively activate T cells at a range of concentrations and to carry out highly targeted cell killing exclusively on those cells that were positive for NY-ESO-1, from which the SLL peptide is derived. This demonstrates proof-of-concept for the ability of DARPin® therapeutics to effectively drug peptide-MHC complexes.

Thirdly, a poster to be presented on AMG 506 / MP0310 (FAP x 4-1BB) describes pharmacokinetic and pharmacodynamic research to establish the optimal dose range for this novel tumor-localized immune agonist. AMG 506 / MP0310 is now in a Phase 1 clinical study.

The details are as follows:

  • MP0317: An oral presentation of MP0317 titled “A tumor-targeted CD40 agonistic DARPin® molecule leading to antitumor activity with limited systemic toxicity” will take place during the minisymposium entitled “Immunomodulatory Agents and Interventions” and will be accessible here.
  • Peptide-MHC DARPin®: “Application of the DARPin® technology for specific targeting of tumor-associated MHC class I: peptide complexes”, Poster No. 690
  • AMG 506 / MP0310: “Selection of first-in-human clinical dose range for the tumor-targeted 4-1BB agonist MP0310 (AMG 506) using a pharmacokinetic/pharmacodynamics modeling approach”, Poster No. 2273

Following their presentation, the posters will be made available on the corresponding section of the Molecular Partners website.

Financial Calendar

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 DARPin® Therapeutics

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

About Molecular Partners AG

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

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

For further details, please contact:

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

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

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

Disclaimer

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

Molecular Partners Confirms Ultra-Potent Inhibition of SARS-CoV-2 Live Virus by Anti-COVID-19 DARPin® Candidates

  • DARPin® antiviral candidates demonstrate low picomolar potency in live virus assay
  • Candidate construction complete; two candidates ready for preclinical development & manufacturing
  • Therapeutic profile of a highly potent antiviral biologic with a long half-life supports both a prophylactic and therapeutic approach
  • Initiation of clinical studies planned for H2 2020

Zurich-Schlieren, Switzerland, May 7, 2020. Molecular Partners AG (SIX: MOLN), a clinical-stage biotech company that is developing a new class of custom-built protein therapeutics known as DARPin® therapeutics, today announced completion of in vitro potency assessments of its DARPin® candidates targeting live, replicating coronavirus SARS-CoV-2. These candidates show extremely robust antiviral activity, with several candidates demonstrating complete neutralization with low picomolar potency. This suggests only very small amounts of these candidates may be required for therapeutic effect, which complements the company’s ability to rapidly manufacture DARPin® candidates with high yields.

“We are greatly encouraged by the emerging therapeutic profile of our program, that we believe suits the needs of this global pandemic. Our thanks to our colleagues at the Spiez Laboratory for working with us in testing our candidates against the live virus. Given the potency we see from these candidates, combined with characteristics of DARPin® therapeutics such as their manufacturability, low immunogenicity and shelf-stability, we are confident in moving to the next phase of work,” said Patrick Amstutz, Chief Executive Officer of Molecular Partners. “We continue to progress this program at high speed and expect to select a clinical candidate in the coming weeks, while we advance our plans for large-scale GMP manufacturing.”

The DARPin® candidates are half-life-extended and contain three distinct monomer DARPin® proteins that can simultaneously target the virus in different key areas, leading to cooperative binding and contributing to the extremely high potency now seen in vitro. The approach also allows neutralization of the virus via multiple mechanisms. Another significant advantage of a multi-specific antiviral is its potential ability to protect against viral ‘escape’, whereby a virus may develop resistance to any one antiviral mechanism.

The anti-COVID-19 candidates have subsequently been tested against the live virus, with assistance from the Spiez Laboratory, a division of the Swiss Federal Office for Civil Protection. In the completed in vitro potency assessments, dose-response assays with live, infectious SARS-CoV-2 virus showed that the selected candidates had an effective concentration for 50% inhibition (EC50) of less than 100 picomolar (pM) and completely inhibited infectious SARS-CoV-2 virion replication at low triple-digit pM concentrations.

“The DARPin® candidates show potent ant-viral activity against SARS-CoV-2 in our in vitro assay at Spiez Lab. We are looking forward to continue working with the Molecular Partners team on this project,” said Dr. Olivier Engler , Head of Virology at Spiez Laboratory.

From these tests, two candidates have been identified and will now move into in vivo studies, which will begin in May 2020. In parallel, GMP manufacturing is being secured, and the company is preparing for initiation of clinical studies in H2 2020.

About Molecular Partners’ anti-COVID-19 program

Molecular Partners is advancing antiviral DARPin® candidates with strong binding and neutralizing qualities against multiple epitopes on the SARS-CoV-2 spike protein that are crucial for infection. The company’s selection of a multi-specific DARPin® lead candidate will be based on its capability to perform three distinct mechanisms of action: blocking binding of the human ACE2 receptor, the virus’s primary docking mechanism to host cells; blocking binding of a specific protease essential for spike protein activation; and “handcuffing” the spike protein, preventing the conformational change it undergoes prior to injection of viral RNA into the human cell. One advantage of a multi-specific antiviral is its potential ability to protect against viral ‘escape’, whereby a virus may develop resistance to any one antiviral mechanism. The final candidate is also expected to have its half-life enhanced with a DARPin® domain that binds to human serum albumin (HSA) to support long-acting activity.

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

About DARPin® therapeutics

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

About Molecular Partners AG

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

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

For further details, please contact:

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

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

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

Disclaimer

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

Interim Management Statement Q1 2020: Continued progress on Abicipar, sharpened focus on pipeline activities

Research & Development Highlights:

  • Abicipar in neovascular wet age-related macular degeneration (nAMD):
    • Presentation of MAPLE data at the 2020 Angiogenesis, Exudation, and Degeneration symposium showed lower rates of intra-ocular inflammation than the rate observed in Phase 3 studies, as well as no incidences of retinal vasculitis
    • In March, a filing for approval of abicipar in nAMD was submitted to the Japanese Pharmaceuticals and Medical Devices Agency
    • In March, a manuscript detailing the pooled phase 3 data of abicipar was accepted for publication by Ophthalmology, the journal of the American Academy of Ophthalmology
  • MP0250 in multiple myeloma:
    • Discussions regarding potential collaborations for MP0250 are ongoing
    • As of April 30th, 2020, thirty patients have been enrolled at the 8mg/kg cohort in its ongoing study MP0250-201. 5/30 patients still receiving treatment will be monitored and treated, per protocol. The company will not enroll additional patients in this study.
  • AMG 506 (MP0310) in solid tumors:
    • Dose escalation ongoing with continued strong recruitment
    • Data from the dose escalation cohorts will be used to inform potential Ph1b combination studies with Amgen assets and will be conducted by Amgen
  • MP0317 (FAP X CD40):
    • United States Food and Drug Administration (FDA) Investigational New Drug Application (IND)-enabling work continues to progress
    • IND filing anticipated around the end of 2020
  • Three scientific posters accepted for 2020 American Academy for Cancer Research (AACR) Annual Meeting, to be held virtually from June 22-24
    • Topics will cover AMG 506, MP0317, and peptide-MHC DARPin® programs
  • In April, the company announced its efforts to design a highly potent DARPin® antiviral therapeutic against SARS-CoV-2, with candidate selection ongoing, and the potential to initiate clinical studies in H2 2020

Operational & Financial Highlights:

  • Election of three new members to our Board of Directors, including Sandip Kapadia, Vito Palombella Ph.D., and Michael Vasconcelles, M.D.
  • Cash and short-term deposits of CHF 80.7M as of March 31, 2020
  • Net cash used in operating activities of CHF 12.8M
  • Operating loss of CHF 12.2M and net loss of CHF 13.3M in Q1 20
  • Company funded into H2 2021, not including potential milestones from ongoing partnerships

 

Zurich-Schlieren, Switzerland, May 7, 2020. Molecular Partners AG (SIX: MOLN), a clinical-stage biotech company that is developing a new class of custom-built protein therapeutics known as DARPin® therapeutics, announced today its interim management statement for the period ending March 31, 2020.

“We have responded to the current global pandemic in three ways: ensuring the safety of our employees and other stakeholders; preserving continuity of operations with appropriate safeguards; and initiating an accelerated anti-COVID-19 program to leverage the compelling advantages of the DARPin® platform against the novel coronavirus. As we prepare for the FDA’s decision regarding abicipar, which would be the first approved DARPin® therapeutic, we have continued to progress our broad pipeline of next-generation multi-DARPin® candidates,” said Patrick Amstutz, Ph.D., Chief Executive Officer of Molecular Partners. “Our focus as ever is excellence in scientific innovation executed by a team united by a common purpose to deliver an entirely new class of medicine.”

Clinical Updates:

MP0250 in multiple myeloma

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. As of April 30th, 2020, thirty patients have been enrolled at the 8mg/kg cohort in its ongoing study MP0250-201. 5/30 patients still receiving treatment will be monitored and treated, per protocol. The company will not enroll any additional patients into this study. As discussed at the December 2019 R&D Day, the company is focusing on identifying collaborators best placed to accelerate this program.

 

Phase 1 trial of AMG 506 (MP0310) continues dose escalation

For AMG 506 (MP0310), the phase 1 MP0310-CP101 trial is ongoing and dose escalation is underway. The trial will enroll up to 54 patients at three sites in France to evaluate the safety, tolerability and pharmacokinetics of AMG 506 (MP0310) in patients with locally advanced or metastatic solid tumors. 

 

MP0317 (FAP x CD40) IND-enabling work continues to progress

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. As previously indicated, the company anticipates filing an IND for MP0317 around the end of 2020.

 

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

Recruitment for the dose escalation phase of the phase 1 trial of MP0274 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.

 

Abicipar: Additional filing in Japan, and data presented demonstrating improved tolerability of Abicipar in the MAPLE study

In February 2020, at the Angiogenesis, Exudation, and Degeneration symposium, a presentation titled “Update on the Safety and Efficacy of Abicipar Pegol” was provided by Baruch D. Kuppermann, M.D., Ph.D. This presentation reviewed data from both, the 2-year follow-up data of the CEDAR and SEQUOIA phase 3 studies as well as the MAPLE study, which was a 28 week open-label study that evaluated Abicipar produced via a modified manufacturing process and has demonstrated a lower inflammation rate than the rate observed in Phase 3 studies.   The data presented showed that in year 2 of the CEDAR and SEQUOIA study and in the MAPLE study there were no incidences of retinal vasculitis.

In March 2020, an application to approve abicipar for the treatment of nAMD was filed to the Japanese Pharmaceuticals and Medical Devices Agency.

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

Molecular Partners’ financial performance for the first three months of 2020 reflects an operating cash outflow of CHF 12.8 million. Cash and short-term deposits decreased by CHF 14.4 million in Q1 2020 to CHF 80.7 million as of March 31, 2020 (year-end 2019: CHF 95.1 million).

As of March 31, 2020, the company employed 139.6 FTEs, a 14% increase year-over-year, with approximately 85% of employees serving in R&D functions.

Business outlook and priorities

In 2020, Molecular Partners anticipates regulatory decisions by the FDA and European Medicines Agency (EMA) regarding the market launch of abicipar for patients with nAMD. The FDA is expected to take action on the Biologics License Application (BLA) by 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 conclude 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 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, International Financial Reporting Standards (IFRS) pension accounting and depreciations.

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; in addition to potential external impacts such as the ongoing COVID-19 global pandemic. 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

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 DARPin® therapeutics

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

About Molecular Partners AG

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

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

For further details, please contact:

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

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

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

Disclaimer

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

Shareholders of Molecular Partners AG Approve all Board Proposals at the Annual General Meeting – Sandip Kapadia, Michael Vasconcelles and Vito J. Palombella elected new Board Members

Zurich-Schlieren, Switzerland, April 29, 2020. At today’s Annual General Meeting of Molecular Partners AG (SIX: MOLN), a clinical-stage biotech company that is developing a new class of custom-built protein therapeutics known as DARPin® therapeutics, the shareholders of the company approved all motions proposed by the Board of Directors with a very large majority.

In light of the current situation around the Corona virus and in line with the applicable Swiss regulation, this year’s Annual General Meeting was conducted solely by voting through the independent proxy and without physical attendance of shareholders.

The shareholders of the company elected Sandip Kapadia, Michael Vasconcelles and Vito J. Palombella as new members of the Board of Directors of Molecular Partners. The three new Board members bring extensive expertise in the fields of oncology drug discovery, translational science, clinical development, portfolio management, commercial product launch, and capital formation to the company.

Bill Burns, Gwen Fyfe, Steven H. Holtzman and Patrick Amstutz were re-elected as members of the Board of Directors for a term of office until the 2021 Annual General Meeting. Bill Burns was also re-elected as Chairman of the Board of Directors. The shareholders further elected the three proposed members of the Nomination and Compensation Committee – Bill Burns, Steven H. Holtzman and Michael Vasconcelles.

The election of the three new board members coincided with the departure of Goran Ando, William Lee and Petri Vainio from the Board of Directors of Molecular Partners. Each of these board members has dutifully served on the board of the company for 10 years or more and did not stand for re-election at today’s Annual General Meeting.

“As we welcome our three new Board members, 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. All three remain 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,” commented Bill Burns today’s successful transition of the Board.

KPMG AG Zurich was re-elected as the Group’s statutory auditors for the financial year 2020 and Anwaltskanzlei Keller KLG, Zurich, elected as the independent proxy for a term of office until the 2021 Annual General Meeting.

The shareholders of the company renewed the authorization of the Board of Directors of Molecular Partners AG to increase the share capital of the company within a period of two years. The Annual General Meeting approved all (binding) motions regarding compensation of the Board of Directors and the Management Board. Further, the shareholders of Molecular Partners AG approved the annual report and the annual financial statements for the financial year 2019, the appropriation of the 2019 results, the appropriation of reserves, as well as the compensation report (in a consultative vote). The Board of Directors and the Management Board were granted discharge for the financial year 2019.

Financial Calendar

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 DARPin® therapeutics

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

About Molecular Partners AG

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

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

For further details, please contact:

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

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.