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

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

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

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

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

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

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

About Molecular Partners’ anti-COVID-19 program

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

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

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

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

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

About Molecular Partners AG

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

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

For further details, please contact:

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

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

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

Forward-looking statements

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

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

Details for the presentations are as follows:

HC Wainwright 22nd Annual Global Investments Conference

Presentation Date:           Monday, September 14, 2020

Presentation Time:           11:30 a.m. ET

 

Morgan Stanley Global Healthcare Conference

Presentation Date:           Wednesday, September 16, 2020

Presentation Time:           1:15 p.m. ET

 

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

About Molecular Partners AG

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

For further details, please contact:

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

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

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

Research & Development:

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

Team:

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

Financial highlights:

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

 

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

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

 

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

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

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

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

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

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

 

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

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

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

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

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

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

 

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

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

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

 

Financial highlights: Private placement extends cash runway into 2022

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

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

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

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

Key figures as of June 30, 2020

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

Business outlook and priorities

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

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

Financial outlook 2020

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

Documentation

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

H1 2020 conference call

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

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

Switzerland / Europe                 +41 (0) 58 310 5000

UK                                                       +44 (0) 207 107 0613

USA                                                    +1 (1) 631 570 5613

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

Audio webcast

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

Financial Calendar

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

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

About DARPin® therapeutics

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

About Molecular Partners AG

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

For further details, please contact:

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

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

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

Disclaimer

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

• 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.

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

• 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.

• 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.

 

• 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.

 

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

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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.

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.