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Zurich-Schlieren, Switzerland, June 15, 2021. Molecular Partners AG (SIX: MOLN), a clinical-stage biotech company developing a new class of custom-built protein drugs known as DARPin® therapeutics, today announced the pricing of its initial public offering in the United States of 3,000,000 American Depositary Shares (“ADSs”) at a public offering price of $21.25 per ADS, for total gross proceeds of approximately $63.8 million. All ADSs sold in the offering were offered by Molecular Partners. Each ADS will represent one Molecular Partners ordinary share. The new ordinary shares underlying the ADSs will be issued from Molecular Partners’ authorized capital under exclusion of the existing shareholders’ pre-emptive rights. In addition, Molecular Partners has granted the underwriters a 30-day option to purchase up to an additional 450,000 ADSs at the initial public offering price, less underwriting discounts and commissions.

Trading of the ADSs is expected to commence on The Nasdaq Global Select Market on Wednesday, June 16, 2021 under the ticker symbol “MOLN.” SIX Swiss Exchange (“SIX”) approved the listing of the new ordinary shares underlying the ADSs as of June 17, 2021.

On June 16, 2021, trading of the existing shares of Molecular Partners on SIX will be halted. If trading of the ADS on the Nasdaq will commence at 4 p.m. CEST on June 16, 2021 or any time before, trading of the shares of Molecular Partners on SIX will reopen on the same day. If trading on the Nasdaq starts later, trading of the shares in Molecular Partners on SIX will reopen on June 17, 2021 only.

The offering is expected to close on or about June 18, 2021, subject to customary closing conditions.

J.P. Morgan, SVB Leerink and Cowen are acting as joint book-running managers for the proposed offering. RBC Capital Markets is acting as the bookrunner for the proposed offering. Kempen & Co is acting as the lead manager for the proposed offering.

A registration statement on Form F-1 relating to these securities became effective on June 15, 2021. The securities referred to in this release are to be offered only by means of a prospectus. Copies of the final prospectus relating to the offering may be obtained, when available, for free by visiting EDGAR on the SEC website at www.sec.gov. Alternatively, a written copy may be obtained for free from J.P. Morgan Securities LLC, c/o Broadridge Financial Solutions, 1155 Long Island Avenue, Edgewood, New York 11717, telephone: 1-866-803-9204; SVB Leerink LLC, Attention: Syndicate Department, One Federal Street, 37th Floor, Boston, MA 02110, by telephone at 1-800-808-7525, ext. 6105, or by e-mailing syndicate@svbleerink.com; Cowen and Company, LLC (c/o Broadridge Financial Services), 1155 Long Island Avenue, Edgewood, NY, 11717, Attn: Prospectus Department, by telephone at (833) 297-2926 or by email at PostSaleManualRequests@broadridge.com. The securities may not be sold, nor may offers to buy be accepted, prior to the time the registration statement becomes effective. In connection with the listing of the ordinary shares on the SIX, the registration statement on Form F-1 constitutes a foreign prospectus within the meaning of article 54 paras. 2 and 3 of the Swiss Financial Services Act of June 15, 2018 (“FinSA”) and article 70 paras. 2-4 of the Swiss Financial Services Ordinance of November 6, 2019 (“FinSO”). The registration statement on Form F-1, including the preliminary prospectus, as well as the final prospectus, once available, will be deposited with the Prospectus Office of SIX Exchange Regulation. Further, the inclusion of the foreign prospectus in the prospectus list published by the Prospectus Office of SIX Exchange Regulation will be requested.

This press release shall not constitute an offer to sell or the solicitation of an offer to buy these securities, nor shall there be any sale of these securities in any state or jurisdiction in which such offer, solicitation or sale would be unlawful prior to registration or qualification under the securities laws of any such state or jurisdiction. There is no intention or permission to publicly offer, solicit, sell or advertise, directly or indirectly, any securities of Molecular Partners in or into Switzerland within the meaning of FinSA.

 

About Molecular Partners AG

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

 

For further details, please contact:

Investors:
Seth Lewis
seth.lewis@molecularpartners.com
Tel: +1 781 420 2361

Media:
Shai Biran, Ph.D.
shai.biran@molecularpartners.com
Tel: +1 978 254 6286

Thomas Schneckenburger, European IR & 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, including expectations regarding the commencement of trading of ADSs on The Nasdaq Global Select Market and the completion of the proposed securities offering. 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, and no assurance can be given that the proposed securities offering discussed above will be consummated on the terms described or at all. Completion of the proposed offering and the terms thereof are subject to numerous factors, many of which are beyond the control of Molecular Partners, including, without limitation, market conditions, failure of customary closing conditions and the risk factors and other matters set forth in Molecular Partners’ filings with the SEC. 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.

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• Global Phase 3 trial designed to investigate safety and efficacy of ensovibep in hospitalized adults with COVID-19

• Ensovibep receives U.S. FDA Fast Track Designation for the treatment of COVID-19 in both hospitalized and ambulatory settings

Zurich-Schlieren, Switzerland, June 13, 2021. Molecular Partners AG (SIX: MOLN), a clinical-stage biotech company developing a new class of custom-built protein drugs known as DARPin® therapeutics, today announced that the first patient has been dosed in a new Phase 3 sub-study evaluating ensovibep, as part of the National Institutes of Health’s (NIH) Accelerating COVID-19 Therapeutic Interventions and Vaccines (ACTIV) public-private partnership designed to speed development of treatments and vaccine candidates for COVID-19. Molecular Partners also announced that the U.S. Food and Drug Administration (FDA) has granted ensovibep Fast Track designation, which is intended to expedite the development and review of new therapies to treat serious conditions and fill an unmet medical need.

As part of the ACTIV-3 international master protocol, the new Phase 3 sub-study is designed to evaluate the safety and efficacy of ensovibep for the treatment of COVID-19 positive adults in the hospitalized setting. Ensovibep is an anti-SARS-CoV-2 investigational DARPin® therapeutic candidate designed to bind the virus’ spike protein on three distinct sites simultaneously to inhibit viral entry into cells and proliferation of the virus. In order to be selected for ACTIV-3, Molecular Partners provided the NIH with relevant data and in addition provided ensovibep for independent preclinical assessments by the NIH.

Initial results from a Phase 1 trial evaluating ensovibep in healthy volunteers were announced in March 2021, indicating that ensovibep was well tolerated with a half-life in the range of 2-3 weeks. These promising results have informed the decision to move forward with the EMPATHY clinical trial program, which initiated enrollment in May 2021, and is being conducted by Novartis, with Molecular Partners as sponsor. The EMPATHY trial is a Phase 2 and 3 study that will seek to enroll 2,100 patients with COVID-19 in the ambulatory setting, to evaluate the safety and efficacy of ensovibep in preventing worsening symptoms and hospitalizations.

ACTIV-3 Clinical Trial Design

As previously described, the ACTIV-3 trial arm evaluating ensovibep is planned to initially enroll 300 participants who have been hospitalized with mild to moderate COVID-19 with fewer than 13 days of symptoms, who will receive either ensovibep or placebo. Participants will also receive standard of care for COVID-19, including the FDA-approved antiviral remdesivir. Five days after dosing, participants’ clinical status will be assessed, based on need for supplemental oxygen, mechanical ventilation, or other supportive care. The protocol includes an interim analysis for futility after the first 300 patients have been randomized and recruited. If the ensovibep treatment arm appears to have a positive benefit:risk profile, the trial will enroll an additional 700 participants. Trial participants will be followed for 90 days following enrollment to analyze their response to treatment. The primary efficacy endpoint is the time from randomization to participants’ sustained recovery for 14 days after release from the hospital.

 

About ACTIV

On April 17, 2020 the National Institutes of Health (NIH) announced the Accelerating COVID-19 Therapeutic Interventions and Vaccines (ACTIV) public-private partnership to develop a coordinated research strategy for prioritizing and speeding development of the most promising treatments and vaccines.

Coordinated by the Foundation for the National Institutes of Health (FNIH), ACTIV brings NIH together with its sibling agencies in the Department of Health and Human Services, including the Biomedical Advanced Research and Development Authority (BARDA), Centers for Disease Control and Prevention (CDC), and the U.S. Food and Drug Administration (FDA); other government agencies including the Department of Defense (DOD) and Department of Veterans Affairs (VA); The Operation (formerly known as Operation Warp Speed); the European Medicines Agency (EMA); and representatives from academia, philanthropic organizations, and numerous biopharmaceutical companies

 

About Molecular Partners’ anti-COVID-19 program

Molecular Partners’ two antiviral DARPin® candidates, ensovibep and MP0423, are designed to target multiple different sites on the SARS-CoV-2 virus simultaneously for enhanced antiviral effects and potential use as both prophylactics and treatments. The potential benefits of this multi-specificity include cooperative binding, high potencies and potential prevention of viral ‘escape’ via mutations. The candidates are formatted with a DARPin® domain that binds to human serum albumin (HSA) to support a longer half-life and hence longer activity. All DARPin® candidates are constructed to benefit from high-yield and cost-effective manufacturing. Molecular Partners is investigating whether the high thermal stability of DARPin® molecules can be used to overcome cold-chain requirements.

In October 2020, Molecular Partners entered into a collaboration with Novartis AG in the form of an option and license agreement to develop, manufacture and commercialize Molecular Partners’ anti-COVID-19 DARPin® candidates. Per the terms of the agreement, Molecular Partners will conduct Phase 1 clinical trials for ensovibep and, if agreed by the parties, perform all remaining preclinical work for MP0423; Novartis is conducting Phase 2 and Phase 3 clinical trials, with Molecular Partners as sponsor of those trials. Upon exercise of its option to exclusively license global rights of ensovibep and MP0423, Novartis would be responsible for all further development and commercialization activities. Molecular Partners is also collaborating with AGC Biologics, Baccinex, and Ivers-Lee Clinical Supply Management (IL-CSM) 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 ensovibep, if it is approved in Switzerland.

In March 2021, Molecular Partners announced positive initial data from its Phase 1 study of ensovibep in healthy volunteers, which demonstrated that ensovibep was well-tolerated with a half-life of 2-3 weeks. In March 2021 Molecular Partners initiated a single-arm Phase 2 study of ensovibep in COVID-19-positive patients in the ambulatory settings, at a single center in the Netherlands. In May 2021, Novartis and Molecular Partners initiated enrollment in EMPATHY, a Phase 2-3 study of ensovibep. The study will seek to enroll 2,100 patients with COVID-19 in the ambulatory settings, to evaluate the safety and efficacy of ensovibep in preventing worsening symptoms and hospitalizations.

 

About Molecular Partners AG

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

 

For further details, please contact:

Investors:
Seth Lewis
seth.lewis@molecularpartners.com
Tel: +1 781 420 2361

Media:
Shai Biran, Ph.D.
shai.biran@molecularpartners.com
Tel: +1 978 254 6286

Thomas Schneckenburger, European IR & 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. 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, and include, without limitation, statements regarding the design, timing and results of the ongoing ACTIV-3 and EMPATHY clinical trials for ensovibep, including patient enrollment expectations; and the potential of ensovibep to provide therapeutic benefit to COVID-19 patients. 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. 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, including, without limitation: the cost, timing and results of clinical trials; that many drug candidates do not become approved drugs on a timely or cost effective basis or at all; the ability to enroll patients in our clinical trials; possible safety and efficacy concerns; the inherent uncertainties associated with preclinical and clinical trial and product development activities and regulatory approval requirements; and risks that preliminary results from clinical trials are not necessarily predictive of future clinical trial results. 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.

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Zurich-Schlieren, Switzerland, June 9, 2021. Molecular Partners AG (SIX: MOLN), a clinical-stage biotech company developing a new class of custom-built protein drugs known as DARPin® therapeutics, today announced that it has commenced an initial public offering in the United States of 3,000,000 American Depositary Shares (“ADSs”) pursuant to a registration statement on Form F-1 (File No. 333-255447), as amended, that has been filed with the U.S. Securities and Exchange Commission (the “Offering”). In connection with the Offering, Molecular Partners expects to grant the underwriters a 30-day option to purchase additional ADSs of up to 15% of the total number of ADSs placed in the Offering (i.e. up to 450,000 additional ADSs). Each ADS will represent one Molecular Partners ordinary share. The new ordinary shares underlying the ADSs will be issued from Molecular Partners’ authorized capital under exclusion of the existing shareholders’ pre-emptive rights. The terms of the Offering have not been determined, and the Offering is subject to market and other conditions, and there can be no assurance as to whether or when the Offering may be completed or as to the actual size or terms of the Offering.

The number of ADSs to be offered and the price for the ADSs in the proposed Offering will be determined on the pricing date (expected for the week of June  14, 2021). The final price of the offered ADSs will be determined largely on the basis of the closing price of Molecular Partners’ shares on the Swiss Stock Exchange on the pricing date translated into U.S. dollars at the then prevailing exchange rate and using an ADS to share ratio of one to one. Application has been made to list the ADSs on the Nasdaq Global Market in the United States under the ticker symbol “MOLN” and the new ordinary shares underlying the ADSs on the SIX Swiss Exchange (“SIX”). The new shares will rank pari passu with Molecular Partners’ existing shares which are already listed on the SIX pursuant to the International Reporting Standard.

J.P. Morgan, SVB Leerink and Cowen are acting as joint book-running managers for the proposed offering. RBC Capital Markets is acting as the bookrunner for the proposed offering. Kempen & Co is acting as the lead manager for the proposed offering.

The securities referred to in this release are to be offered only by means of a prospectus. Copies of the preliminary prospectus relating to the offering may be obtained, when available, for free by visiting EDGAR on the SEC website at www.sec.gov. Alternatively, from J.P. Morgan Securities LLC, c/o Broadridge Financial Solutions, 1155 Long Island Avenue, Edgewood, New York 11717, telephone: 1-866-803-9204; SVB Leerink LLC, Attention: Syndicate Department, One Federal Street, 37th Floor, Boston, MA 02110, by telephone at 1-800-808-7525, ext. 6105, or by e-mailing syndicate@svbleerink.com; Cowen and Company, LLC (c/o Broadridge Financial Services), 1155 Long Island Avenue, Edgewood, NY, 11717, Attn: Prospectus Department, by telephone at (833) 297-2926 or by email at PostSaleManualRequests@broadridge.com.

A registration statement on Form F-1 relating to these securities has been filed with the U.S. Securities and Exchange Commission but has not yet become effective. The securities may not be sold, nor may offers to buy be accepted, prior to the time the registration statement becomes effective. In connection with the listing of the ordinary shares on the SIX, the registration statement on Form F-1, once declared effective, constitutes a foreign prospectus within the meaning of article 54 paras. 2 and 3 of the Swiss Financial Services Act of June 15, 2018 (“FinSA”) and article 70 paras. 2-4 of the Swiss Financial Services Ordinance of November 6, 2019 (“FinSO”).

This press release shall not constitute an offer to sell or the solicitation of an offer to buy these securities, nor shall there be any sale of these securities in any state or jurisdiction in which such offer, solicitation or sale would be unlawful prior to registration or qualification under the securities laws of any such state or jurisdiction. There is no intention or permission to publicly offer, solicit, sell or advertise, directly or indirectly, any securities of Molecular Partners in or into Switzerland within the meaning of FinSA.

 

About Molecular Partners AG

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

 

For further details, please contact:

Investors:
Seth Lewis
seth.lewis@molecularpartners.com
Tel: +1 781 420 2361

Media:
Shai Biran, Ph.D.
shai.biran@molecularpartners.com
Tel: +1 978 254 6286

Thomas Schneckenburger, European IR & 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.

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• EMPATHY global multi-center Phase 2 – 3 study, recruiting patients with COVID-19 infection, aiming to prevent worsening symptoms and hospitalization

• The study plans to enroll 2100 patients, with 400 patients to be enrolled into Phase 2, followed by 1700 patients in Phase 3

• Novartis has been granted an option from Molecular Partners to in-license global rights of ensovibep and MP0423 – DARPin® antiviral therapeutic candidates that are undergoing testing to target SARS-CoV-2 spike protein

• DARPin® therapeutics well suited for a pandemic setting due to multi-specific target binding, long half-life for sustained activity and highly scalable production, compared to monoclonal antibodies

Zurich-Schlieren, Switzerland, May 27, 2021. Molecular Partners AG (SIX: MOLN) and Novartis announced today the start of the clinical trial EMPATHY, a Phase 2 and 3 study, to explore the use of its novel DARPin® therapeutic candidate ensovibep (MP0420) for the treatment of COVID-19. Novartis will conduct the clinical trial program for ensovibep, with Molecular Partners as sponsor of the studies. In March 2021, Molecular Partners reported positive initial Phase 1 results in healthy volunteers.

The EMPATHY clinical trial program is investigating the safety and efficacy of ensovibep in patients with COVID-19, who are in the early stages of infection, to prevent worsening symptoms and hospitalization. The study will enroll 400 patients in Phase 2 to identify a dose with optimal safety and activity, with initial results anticipated in August 2021. At that point Phase 3 will move ahead with an additional 1,700 patients with results anticipated in H1 2022. If the initial EMPATHY trial results are convincing, this would pave the way for Novartis to seek expedited approval via the FDA’s Emergency Use Authorization (EUA).

Those eligible for the EMPATHY trial are adults, over the age of 18, with a positive SARS-CoV-2 antigen test and who are experiencing at least two pre-determined mild/moderate symptoms of COVID-19 within 7 days of their diagnosis.

“Novartis remains unwavering in our efforts to help combat COVID-19, including our support to deliver treatment options for patients around the globe,” said Dr. Lutz Hegemann, Group Head, Corporate Affairs and Global Health, Novartis. “Today, with Molecular Partners, we’re announcing an important next step in the development of ensovibep, which holds promise to respond to breakthrough disease and new variants in the future. We are hopeful the results of this clinical trial program will provide a reliable treatment option for patients with COVID-19.”

Novartis believes a multi-solution strategy is needed to overcome COVID-19, one that utilizes a range of diagnostic and therapeutic options, depending on the needs of individual patients. Every country should have access to effective medicines to treat COVID-19 and despite availability of vaccinations, there continues to be disease transmission and there is likely to continue to be breakthrough disease.

“By virtue of its tri-specific design, ensovibep was built to resist viral mutations and indeed shows potent inhibition of all variants of concern to date, with the potential to maintain activity also for future variants. This type of broad spectrum activity is essential for any treatment of relevance for patients with COVID-19,“ said Patrick Amstutz, Chief Executive Officer, Molecular Partners. “Reaching this important clinical milestone is not only a key step to combat this virus, but also validating our DARPin approach to generate multispecific antiviral therapies in the fight against global pandemics.”

Initial findings from the Phase 1 trial of ensovibep showed it to be safe and well tolerated with no significant adverse events. Predictable exposure was seen post-administration, confirming the expected half-life of two to three weeks. These data confirmed the systemic administration of a multi-specific DARPin® antiviral therapy to be safe and well tolerated and support plans for additional clinical work in patients diagnosed with COVID-19, as part of the EMPATHY trial. The preclinical work for MP0423 is still ongoing and is being led by Molecular Partners.

 

Sustained binding against new variants of Covid-19

Molecular Partners, in collaboration with academic and government partners, has conducted in vitro experiments using pseudovirion models of SARS-CoV-2 to analyze for infectivity in the presence of ensovibep. These models represent new variants first identified in UK (B1.1.7), South Africa (B.1.351), Brazil (P.1), California (B.1.429), New York (B.1.526), emerging variants R.1 and A.23.1, the individual key mutations of the variants identified in India, B.1.617 and B.1.618, and other key spike mutations identified to date. The results suggest ensovibep continues to retain full potency against the new viral variants of SARS-CoV-2, and could have the potential for sustained binding to additional COVID-19 variants, as they may appear in the future.

 

Ensovibep enrollment in ACTIV-3 trial

Molecular Partners and Novartis also recently announced the inclusion of ensovibep in the NIH-Sponsored ACTIV-3 Trial (National Institute of Health’s (NIH) Accelerating COVID-19 Therapeutic Interventions and Vaccines (ACTIV) program) that aims to prioritize and push forward development of the most promising COVID-19 therapies. ACTIV-3 is a global Phase 3 trial that will investigate the safety and efficacy of ensovibep in adults hospitalized with COVID-19, with an aim to enroll up to 1,000 patients. The first patient dose is expected to be administered in June 2021, with an interim analysis after 300 patients with mild-to-moderate disease. These patients will receive either ensovibep or a placebo. Trial participants will also receive an existing standard of care for COVID-19, including the FDA-approved antiviral remdesivir. If the treatment has a positive risk-benefit profile, the study will enroll an additional 700 patients for further testing. Ensovibep is the first non-antibody therapy assessed in ACTIV-3, supporting a different approach for COVID-19 treatment.

 

The collaboration with Novartis

Molecular Partners is proud to be collaborating with Novartis to develop two DARPin® therapies designed for potential use against COVID-19, ensovibep and MP0423, with an option for Novartis to in-license global rights from Molecular Partners and development responsibilities to both therapies. Novartis will also be responsible for manufacturing, distribution and commercialization of both therapies.

The development program will be led by Molecular Partners until Phase 1 is complete and will be handed over to Novartis to conduct the pivotal clinical trial EMPATHY, with Phase 2 and 3 trials, with Molecular Partners as sponsor of these trials. Molecular Partners will perform all remaining preclinical work for MP0423.

 

About Molecular Partners AG

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

 

For further details, please contact:

Investors:
Seth Lewis
seth.lewis@molecularpartners.com
Tel: +1 781 420 2361

Media:
Shai Biran, Ph.D.
shai.biran@molecularpartners.com
Tel: +1 978 254 6286

Thomas Schneckenburger, European IR & 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.

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• in vitro studies show ensovibep (MP0420) maintains full potency against the known mutations of SARS-CoV-2, including those present in variants first identified in Brazil, California, India, and New York, in addition to the previously reported variants originating from the UK and South Africa

• Ongoing Phase 2 pilot study of ensovibep in ambulatory patients now expanding into second cohort

• Two global Phase 2 and 3 clinical studies of ensovibep on track for initiation this month

Zurich-Schlieren, Switzerland, May 06, 2021. Molecular Partners AG (SIX: MOLN), a clinical-stage biotech company developing a new class of custom-built protein drugs known as DARPin® therapeutics, today announced results from parallel laboratory studies conducted in collaboration with academic and government partners in Switzerland and the United States. The studies assessed the inhibition of new viral variants by leading SARS-CoV-2 anti-infective molecules, including ensovibep and MP0423. New variants are often associated with faster transmissibility and a potential ability to evade the currently available monoclonal antibodies and the immunity induced by some vaccines. On top of the previously reported inhibition of the variants first identified in the UK and South Africa, the new results reported today show that ensovibep continues to retain full potency against the new viral variants of SARS-CoV-2, including the variants first identified in Brazil, California, and New York as well as the key mutations in the Indian variant.

“By designing ensovibep to target the viral spike protein in three different places, we aimed to create a candidate capable of achieving high potency while retaining efficacy as the virus mutated. These new results show that ensovibep remains, as designed, fully potent against the emerging variants of SARS-CoV-2, which have received increasing attention as our understanding of COVID-19 shifts to regarding it as a chronic, evolving global health concern,” said Patrick Amstutz, Ph.D., chief executive officer of Molecular Partners. “These data are encouraging as we and our partners at Novartis prepare to enter two major clinical trials: EMPATHY in ambulatory patients and the NIH-sponsored ACTIV-3 in hospitalized patients. We are hopeful that these data will translate into patient benefits for those who are potentially infected with these same variants.”

The study design and results will be updated on the research preprint service bioRxiv here. This research builds upon prior analysis of the UK and South African strains, where ensovibep demonstrated full activity, and potential superiority compared to monoclonal antibodies currently being investigated as antiviral cocktails.

In the study update, based on two pseudovirion models, new SARS-CoV-2 variants first identified in Brazil P.1 (L18F, T20N, P26S, D138Y, R190S, K417T, E484K, N501Y, D614G, H655Y, T1027I, V1176F), California B.1.429 (S13I, P26S, W152C, L452R, D614G), New York B.1.526 (L5F, T95I, D253G, E484K, D614G, A701V) as well as emerging variants R.1 (W152L, E484K, D624G, G769V) and A.23.1 (F157L, V367F, Q613H, D614G, P681R) and the individual key mutations of the variants identified in India, B.1.617 and B.1.618, were analyzed for infectivity in the presence of different inhibitors. Ensovibep was shown to strongly neutralize these variants, as well as variants created to harbor multiple individual key point mutations in SARS-CoV-2. While maintaining inhibitory activity, MP0423, the Company’s second COVID-19 candidate, has shown reduced protection against some of the variants. Specifically, mutations in the N-terminal domain were identified to be the key contributors to some reduction of potency. Further analyses in context of the full lineages B.1.617 and B.1.618, first described in India, are ongoing. Full data can be found in the updated bioRxiv publication linked above.

Molecular Partners’ lead anti-COVID-19 therapeutic candidate, ensovibep, has been administered to healthy subjects in the Company’s Phase 1 trial, with initial results showing it to be well-tolerated, with a half-life in the range of 2-3 weeks. Additionally, a single-arm Phase 2 trial with ensovibep in COVID-19 ambulatory patients was initiated in March 2021 at a single center in the Netherlands. The initial Phase 1 results have informed the decision to move forward with the EMPATHY clinical trial program, which is being conducted by our partner Novartis, with Molecular Partners as sponsor. The EMPATHY trial is a global, multi-center Phase 2 and 3 study that will seek to enroll 2,100 patients with COVID-19 in the ambulatory setting, to evaluate the safety and efficacy of ensovibep in preventing worsening symptoms and hospitalizations. In parallel, ensovibep will also be tested in hospitalized COVID-19 patients, in a new sub-trial of the National Institutes of Health’s (NIH) Accelerating COVID-19 Therapeutic Interventions and Vaccines (ACTIV-3) Program Phase 3 clinical trial.

 

About Molecular Partners AG

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

 

For further details, please contact:

Investors:
Seth Lewis
seth.lewis@molecularpartners.com
Tel: +1 781 420 2361

Media:
Shai Biran, Ph.D.
shai.biran@molecularpartners.com
Tel: +1 978 254 6286

Thomas Schneckenburger, European IR & 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.

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Zurich-Schlieren, Switzerland, May 04, 2021. Molecular Partners AG (SIX: MOLN), a clinical-stage biotech company developing a new class of custom-built protein drugs known as DARPin® therapeutics, announced today its interim management statement for the period ending March 31, 2021.

“Molecular Partners continues to grow and expand the reach of our DARPin® therapeutics platform, with the COVID-19 pandemic forming a meaningful change agent for us,” said Patrick Amstutz, Ph.D., chief executive officer of Molecular Partners. “Twelve months ago, we were only at the initiating stages of our COVID-19 program, while this year we are approaching Phase 3 clinical trials with our partners at Novartis. I am extremely proud of our team and partners for not only bringing us to this stage of development in our new antiviral program, but also for continuing to advance our targeted oncology pipeline.”

 

Research & Development Highlights

• COVID-19 antiviral programs:
  • Completed Phase 1 dosing of ensovibep (MP0420) across three dose cohorts, and announced initial positive results
  • Published data showing that ensovibep is effective in vitro against all variants of concern analyzed
  • Initiated single-arm Phase 2 study of ensovibep in COVID-19 positive patients, in the ambulatory setting
  • A global Phase 2 – 3 study in ambulatory patients in collaboration with Novartis initiating enrollment in May 2021

• AMG 506 (MP0310) in solid tumors:
  • Proof of mechanism of action achieved, showing dose-dependent tumor accumulation and local activation of immune cells, as demonstrated after the first dose
  • Clinical studies ongoing to establish optimal dose regimen and activity with weekly dosing
• MP0317 (FAP X CD40):
  • Investigational New Drug Application (IND)-enabling work near completion
  • Expected to enter the clinic in the second half of 2021
• Four scientific posters published recently at the 2021 American Academy for Cancer Research (AACR) Annual Meeting, virtually from April 10-15:
  • Initial results highlighting the Company’s new AML focused multi-specific T-cell engager program
  • Additional data presented for MP0317, CD3 T cell engagers, and peptide-MHC DARPin® programs

 

Operational and financial highlights:

• Election of two new members to the Company’s Board of Directors: Agnete Fredriksen, Ph.D., and Dominik Höchli, M.D.
• Strong financial position with CHF 145.6 million in cash (incl. short term deposits) as of
  March 31, 2021
• Net cash used in operating activities of CHF 29.9 million in Q1 2021
• Operating loss of CHF 18.5 million and net loss of CHF 16.6 million in Q1 2021
• Company funded into 2023, excluding any potential payments from R&D partnerships

 

Clinical Updates:

COVID-19 program advancing in the clinic

Molecular Partners’ lead anti-COVID-19 therapeutic candidate, ensovibep (MP0420), has been administered to healthy subjects in the Company’s Phase 1 trial, with initial results showing it to be safe and well-tolerated, with a half-life in the range of 2-3 weeks. Additionally, a single-arm Phase 2 trial with ensovibep in COVID-19 ambulatory patients was initiated in March 2021 at a single center in the Netherlands. The initial Phase 1 results have informed the decision to move forward with the EMPATHY clinical trial program in April 2021, which is being conducted by our partner Novartis, with Molecular Partners as sponsor. The EMPATHY trial is a global, multi-center Phase 2 and 3 study that will seek to enroll 2,100 patients with COVID-19 in the ambulatory setting, to evaluate the safety and efficacy of ensovibep in preventing worsening symptoms and hospitalizations. In parallel, ensovibep will also be tested in hospitalized COVID-19 patients, in a new sub-trial of the National Institutes of Health’s (NIH) Accelerating COVID-19 Therapeutic Interventions and Vaccines (ACTIV-3) Program Phase 3 clinical trial.

In addition to the clinical development, ensovibep continues to be tested in vitro for its inhibition of infectivity in newly discovered variants of the virus. To date, ensovibep has been shown to be effective in inhibiting viral infectivity in all variants and point mutations of concern.

Phase 1 trial of AMG 506 (MP0310) (FAP X 4-1BB)

As presented in December 2020 at our R&D day, preliminary clinical data from the ongoing Phase 1 clinical trial of AMG 506 (MP0310) show that the molecule performs as intended. AMG 506 (MP0310) showed colocalization with FAP at low concentrations, and the FAP binding was observed to be dose dependent, with a saturation of the tumor-expressed FAP in high AMG 506 (MP0310) concentrations. Furthermore, by analyzing paired biopsies of patients, significant tumor-localized increases in immune activation were seen across multiple immune cell types after a single injection, while systemic inflammatory markers were unchanged, and no AMG 506 (MP0310) activity was seen in peripheral tissues.

Additional dosing work is ongoing in the current Phase 1 clinical trial to test dosing regimens, including the exploration of weekly dosing, aiming to identify the right dose to provide durable activity after several injections of our tumor localized 4-1BB agonist.

MP0317 (FAP x CD40) IND-enabling work complete, scheduled to enter the clinic in H2 2021

In April 2021, Molecular Partners presented data from the MP0317 program at the AACR conference, showing new mechanism of action (MOA) data on the tumor-localized immune agonist MP0317, the second DARPin® protein in the Company’s immuno-oncology pipeline. As previously indicated, the company anticipates entering the clinic with MP0317 on the second half of 2021.

First CD3 T cell engager program to focus on AML therapies

As recently presented at the AACR conference, Molecular Partners’ first CD3 T cell engager will be focused on targeting AML tumor cells as well as T cells, to activate the immune cells against the tumor. Initial proof of concept data shows the Company was able to achieve a wide therapeutic window using a triple- tumor-antigen targeting CD3 DARPin® engager molecule.

 

Balance sheet: Strong cash and equity positions as of March 2021

Molecular Partners’ financial performance for the first three months of 2021 reflects an operating cash outflow of CHF 29.9 million. Cash and short-term deposits decreased by CHF 28.1 million in Q1 2021 to CHF 145.6 million as of March 31, 2021 (year-end 2020: CHF 173.7 million). The decrease in cash and short-term deposits was driven by a large prepayment of CHF 9.3 million for the manufacturing of commercial supply for ensovibep.

As of March 31, 2021, the company employed 151.6 FTEs, a 9% increase year-over-year, with approximately 82% of employees serving in R&D functions.

 

Financial outlook 2021

For the FY 2021, at constant exchange rates, the company continues to expect total expenses of CHF 65-75 million, of which around CHF 6 million will be non-cash effective costs.

In terms of cash outflow the company expects a gross cash utilization of CHF 85-95 million for FY2021, which includes a total of CHF 20 million payable to Novartis for the manufacturing of commercial supply (of which CHF 9.3 million occurred during Q1 2021). This cash flow guidance does not include any potential receipts from R&D partnerships.

With CHF 145.6 million cash at hand and no debt as per March 31, 2021 the company expects to be funded into 2023, excluding any potential receipts from R&D partners.

 

Financial Calendar

26 August 2021                    Publication of Half-year Results 2021 (unaudited)

28 October 2021                  Interim Management Statement Q3 2021

 

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 DARPin® therapeutics, a new class of custom-built protein drugs designed to address challenges current modalities cannot. The Company has formed partnerships with leading pharmaceutical companies to advance DARPin® therapeutics in the areas of ophthalmology, oncology and infectious disease, and has compounds in various stages of clinical and preclinical development across multiple therapeutic areas.

 

For further details, please contact:

Investors:
Seth Lewis
seth.lewis@molecularpartners.com
Tel: +1 781 420 2361

Media:
Shai Biran, Ph.D.
shai.biran@molecularpartners.com
Tel: +1 978 254 6286

Thomas Schneckenburger, European IR & 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.

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Zurich-Schlieren, Switzerland, April 23, 2021. 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 that it has filed a registration statement on Form F-1 with the U.S. Securities and Exchange Commission (the “SEC”) relating to a proposed initial public offering of its American Depositary Shares (“ADSs”), representing common shares, in the United States (the “Offering”). All securities to be sold in the Offering will be offered by the Company. The number of common shares to be represented by each ADS, the number of ADSs to be offered and the price range for the ADSs in the proposed Offering have not yet been determined. The Company has applied to list its ADSs on the Nasdaq Global Market under the ticker symbol “MOLN.” The Company’s common shares are listed on the SIX Swiss Exchange (“SIX”) pursuant to its International Reporting Standard under the ticker symbol “MOLN.”

JP Morgan, SVB Leerink and Cowen & Co. are acting as joint lead bookrunners for the Offering. RBC Capital Markets is also acting as bookrunner and Kempen & Co is acting as lead manager for the Offering.

The securities referred to in this announcement are to be offered only by means of a prospectus. When available, copies of the preliminary prospectus may be obtained from: J.P. Morgan Securities LLC, c/o Broadridge Financial Solutions, 1155 Long Island Avenue, Edgewood, NY 11717, or by telephone at (866) 803-9204, or by email at prospectus-eq_fi@jpmchase.com; Cowen and Company, LLC, c/o Broadridge Financial Solutions, 1155 Long Island Avenue, Edgewood, NY, 11717, Attn: Prospectus Department, by email at PostSaleManualRequests@broadridge.com or by telephone at (833) 297-2926; SVB Leerink LLC, Attention: Syndicate Department, One Federal Street, 37th Floor, Boston, MA 02110, by telephone at (800) 808-7525, ext. 6105.

A registration statement on Form F-1 relating to the securities referred to herein has been filed with the SEC but has not yet become effective. These securities may not be sold, nor may offers to buy be accepted, prior to the time the registration statement becomes effective. This press release does not constitute an offer to sell or the solicitation of an offer to buy securities in any jurisdiction, and shall not constitute an offer, solicitation or sale in any jurisdiction in which such offer, solicitation or sale would be unlawful prior to registration or qualification under the securities laws of that jurisdiction.

The common shares underlying the ADSs are expected to be listed on the SIX. In connection with this listing, the registration statement on Form F-1, once declared effective, constitutes a foreign prospectus within the meaning of article 54 paras. 2 and 3 of the Swiss Financial Services Act of June 15, 2018 (“FinSA”) and article 70 paras. 2-4 of the Swiss Financial Services Ordinance of November 6, 2019 (“FinSO”).

 

About Molecular Partners AG

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

 

For further details, please contact:

Investors:
Seth Lewis
seth.lewis@molecularpartners.com
Tel: +1 781 420 2361

 

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.

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Zurich-Schlieren, Switzerland, April 21, 2021. At today’s AGM of Molecular Partners AG (SIX: MOLN), a clinical-stage biotech company developing a new class of custom-built protein drugs 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 COVID-19 situation 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 Agnete Fredriksen and Dominik Höchli as new members of the Board of Directors of Molecular Partners. Both new board members were determined to be independent and add deep scientific and business expertise in immunotherapy, oncology and infectious disease as well as extensive know-how in clinical affairs and marketing to the company, respectively.

The election of the two new board members coincided with the departure of Gwen Fyfe following her wish not to stand for re-election at today’s Annual General Meeting.

Bill Burns, Steven H. Holtzman, Sandip Kapadia, Michael Vasconcelles, Vito J. Palombella and Patrick Amstutz were re-elected as members of the Board of Directors for a term of office until the 2022 Annual General Meeting. Bill Burns was also re-elected as Chairman of the Board of Directors. The shareholders further re-elected the three proposed members of the Nomination and Compensation Committee – Bill Burns, Steven H. Holtzman and Michael Vasconcelles.

“As we warmly welcome our two new Board members, together with my fellow Board members, we wish to express our deep gratitude for Gwen’s invaluable contributions and commitment to our company during her years of service,” commented Bill Burns on the evolution of the Board of Directors.

KPMG AG Zurich was re-elected as the Group’s statutory auditors for the financial year 2021 and Anwaltskanzlei Keller KLG, Zurich, elected as the independent proxy for a term of office until the 2022 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 2020, the appropriation of the 2020 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 2020.

 

About Molecular Partners AG

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

For more information see www.molecularpartners.com and follow the Company on Twitter at @MolecularPrtnrs.

 

For further details, please contact:

Investors:
Seth Lewis
seth.lewis@molecularpartners.com
Tel: +1 781 420 2361

Media:
Shai Biran, Ph.D.
shai.biran@molecularpartners.com
Tel: +1 978 254 6286

Thomas Schneckenburger, European IR & 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.

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• Data support potential of DARPin® CD3 T-cell engager candidate for improved safety window while limiting tumor escape
• New data show that the FAP x CD40 product candidate, MP0317, led to a localized macrophage repolarization and reversion of T-cell suppression. Clinical trials expected to initiate in the second half of 2021
• Effector control technologies give new potential for enhancing current and future immunotherapies while reducing toxicities

Zurich-Schlieren, Switzerland, April 10, 2021. 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 presentation of four posters highlighting research across its immuno-oncology programs at the American Association for Cancer Research (AACR) virtual Annual Meeting. The preclinical data shared include results from the Company’s acute myeloid leukemia (AML) CD3 T-cell engager program, new data from the MP0317 (FAP x CD40) tumor localized immune activator, and initial results from the Company’s CD3 prodrug programs.

“With our new technologies designed for localized immune activation, targeting of cell surface-displayed peptides derived from intracellular proteins, and T-cell engagement, we believe we have a solid strategy for our new immune-oncology product candidates, and novel design capabilities that have the potential to greatly benefit our own and partnered immuno-oncology programs,” said Daniel Steiner, Ph.D., SVP Research of Molecular Partners. “Our first T-cell engager program is focused on AML, where statistically about half of people diagnosed relapse after treatment and die from the disease. Despite the existence of approved therapies, patients are often unable to benefit from these treatments due to intolerable toxicity. We believe we have made significant progress toward finding a way to avoid this trade-off and widen the therapeutic window for T-cell engagers in AML, aiming to deliver deeper and broader anti-tumor effect and reduce the impact on patients’ healthy cells.”

In preclinical studies, the Company’s AML candidates demonstrated substantial activity against different populations of AML cells in vitro, without significant damage to healthy cells. As shown in the poster titled Novel multi-specific DARPin® T-cell engager with an improved therapeutic window to overcome dose limiting toxicities in AML therapies, Molecular Partners is building on the strength of the DARPin® platform to create a single product designed to target three different cancer antigens simultaneously (CD70, CD33, and CD123). The multi-specific DARPin® T-cell engager candidate is designed to deliver highly potent and specific activity on AML cells, with a reduced effect on healthy normal cells, and with the potential to counteract target escape mechanisms expected due to tumor heterogeneity. In an ex vivo assay using fresh blood from healthy donors, the candidate induced profoundly less inflammatory cytokine production and reduction in platelet counts, unlike simultaneously tested T-cell engager candidates in development by other parties. We believe these data support the designed capability of this candidate to kill a broader population of AML cells while decreasing risk of toxicity.

The T-cell engager research presented today also displays the Company’s prodrug DARPin® technology for tumor-localized release of immune stimulation, through incorporation of a protease cleavable blocker DARPin® molecule. As CD3-binding T-cell engagers are highly potent and can lead to systemic toxicities, Molecular Partners has developed a DARPin® domain designed to mask the CD3 engager from interacting with T cells systemically/outside of the tumor. This technology is aimed at focusing the power of the effector function and reduce toxicities by controlling the location of activation to the tumor microenvironment. In a poster titled A solution to T-cell engager toxicity: An anti-CD3 Prodrug DARPin® (CD3-PDD) shows no toxicity, but potent anti-tumor activity in a humanized mouse model, Molecular Partners presents an anti-CD3 Prodrug DARPin® molecule, CD3-PDD, consisting of an EGFR-binder and a CD3-binder, linked via a protease-cleavable linker to a DARPin® domain masking the CD3 effector function. This-anti EGFR x anti-CD3 – Blocker Prodrug is shown to be unable to bind and recruit T-cells in its non-cleaved state in circulation, and is designed to become activated in the tumor microenvironment upon cleavage of the linker by tumor-associated proteases.

With respect to MP0317, a multi-specific DARPin® product candidate targeting both FAP and CD40 to enable tumor-localized immune activation, new preclinical data demonstrated a localized activation of immune cells in vitro, as well as ex vivo in human tumor samples, dependent on the presence of the FAP protein, which is highly expressed in the stroma of a broad range of solid tumors. The data presented in the poster titled MP0317, a FAPxCD40 targeting multi-specific DARPin® therapeutic, drives immune activation and leads to macrophage repolarization in vitro and ex vivo shows that MP0317 led to macrophage repolarization and reversion of T cell suppression: MP0317 led to upregulation of CD80, an M1 marker, and downregulation of CD163, an M2 marker, only in the presence of FAP, indicating macrophage repolarization towards an M1 phenotype. Furthermore, when these repolarized macrophages were co-cultured with T cells, T cell suppression was shown to revert and CD8 T-cell activation was observed, as shown by the increase of CD25. In both assays the killing effect was comparable to that achieved by an anti-CD40 antibody. We believe these data support MP0317’s potential to deliver tumor-localized CD40-mediated immune cell activation while avoiding systemic toxicity seen in other agents. MP0317 is anticipated to begin clinical trials in the second half of 2021.

Finally, with respect to the Company’s peptide-MHC targeting program, the Company presents preclinical results from a proof of concept study targeting a peptide derived from the NY-ESO-1 protein displayed in the context of a HLA-A2 molecule (a human MHC protein). The poster, Application of the DARPin® technology for specific targeting of tumor-associated MHC class I: peptide complexes, highlights results demonstrating rapid and reliable generation of DARPin® proteins against pMHC which were then formatted into bispecific T-cell engagers, and engineered to enable potent and specific activation of T cells. Further, the results show that the pMHC-targeting DARPin® candidate was able to achieve systemic half-life extension with limited impact on potency.

The posters presented at AACR are available to view in the Scientific Presentations section of Molecular Partners’ corporate website.

 

About Molecular Partners’ Immuno-oncology Product Candidates

Molecular Partners is developing several candidates designed to activate the immune system to fight cancer while reducing damage to healthy cells. These candidates use multiple novel DARPin® technologies potentially applicable against a wide range of tumor types, including DARPin® candidates with the ability to restrict immune activation to the tumor microenvironment, the ability to target intracellular disease-associated proteins, and multiple novel control mechanisms for immune activation designed to direct immune attack to the right cells, at the right place, and at the right time. These capabilities can be combined during candidate design through the inherent modularity of the DARPin® platform, to provide precise control over immune activation and potentially enable more effective cancer immunotherapies.

 

About Molecular Partners AG

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

For more information see www.molecularpartners.com and follow the Company on Twitter at @MolecularPrtnrs.

 

For further details, please contact:

Investors:
Seth Lewis
seth.lewis@molecularpartners.com
Tel: +1 781 420 2361

Media:
Shai Biran, Ph.D.
shai.biran@molecularpartners.com
Tel: +1 978 254 6286

Thomas Schneckenburger, European IR & 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.

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• First study of ensovibep in patients with symptomatic COVID-19 disease
• Designed to evaluate dynamics of viral clearance, pharmacokinetics and tolerability of ensovibep
• Ensovibep is additionally planned to be tested in two global, placebo controlled, double blinded trials: A Phase 2-3 trial in an ambulatory patient setting (named EMPATHY),
  and a Phase 3 trial in a hospitalized patient setting sponsored by the NIH (ACTIV-3)

Zurich-Schlieren, Switzerland, April 06, 2021. 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 that the first patient has been dosed in a Phase 2a clinical trial of ensovibep, a DARPin® therapeutic candidate designed to bind to the SARS-CoV-2 spike protein at three distinct locations to prevent viral entry into cells. The single arm study will enroll patients with symptomatic COVID-19, and is designed to evaluate dynamics of viral clearance, pharmacokinetics and tolerability of ensovibep. The study, recruiting in the Netherlands, is designed to enroll up to 40 patients in two dose cohorts.

“In this first trial of ensovibep in patients, we hope to gain an early look at the viral clearance and the pharmacodynamic behavior of our lead COVID-19 candidate in the presence of the virus. Our preclinical trials with ensovibep have shown that it was able to bind and neutralize SARS-CoV-2 viruses both in vitro and in vivo, including against all currently known mutations of concern,” said Patrick Amstutz, Ph.D., chief executive officer of Molecular Partners. “As part of our development program, we aim to see if these results mechanistically translate into clinical efficacy in patients, with the current trial focused on examining viral presence in treated patients and the potential of the remaining virus to infect cells.”

In a Phase 1, randomized, double-blind, placebo-controlled single ascending dose study for safety, tolerability, and pharmacokinetics of intravenously administered ensovibep, run by Molecular Partners, initial data indicate that ensovibep is well tolerated with a half-life in the range of 2-3 weeks.

In partnership with Novartis, Molecular Partners aims to initiate additional clinical studies of ensovibep throughout the first half of 2021 with the goal of achieving clinical proof-of-concept and potential submission for emergency use authorization within 2021. The intended clinical program includes participation in the NIH’s ACTIV-3 clinical trial, as recently announced, as well as a global Phase 2-3 study (EMPATHY), which will seek to enroll over 2,100 patients in the ambulatory setting to evaluate the ability of ensovibep to prevent disease worsening, hospitalizations and death.

 

About Molecular Partners’ anti-COVID-19 program

Molecular Partners’ two antiviral DARPin® candidates, ensovibep and MP0423, are designed to target multiple different sites on the SARS-CoV-2 virus simultaneously for enhanced antiviral effects and potential use as both COVID-19 prophylaxis and treatment. The benefits of this multi-specificity include cooperative binding, extremely high potencies and potential prevention of viral ‘escape’ via mutations. The candidates are formatted with a DARPin® domain that binds to human serum albumin (HSA) to support a longer half-life and hence longer activity. All DARPin® candidates are constructed to benefit from high-yield and cost-effective manufacturing. Molecular Partners is investigating whether the high thermal stability of DARPin® molecules can be used to overcome cold-chain requirements.

In March 2021, the Company announced positive initial data from its Phase 1 study of ensovibep in healthy volunteers, which showed that ensovibep was safe and well-tolerated with a half-life of 2-3 weeks. In October 2020, Molecular Partners entered into a collaboration with Novartis AG in the form of an option agreement to develop, manufacture and commercialize Molecular Partners’ anti-COVID‑19 DARPin® candidates. Per the terms of the agreement, Molecular Partners will conduct Phase 1 clinical trials for ensovibep and perform all remaining preclinical work for MP0423; Novartis will conduct Phase 2 and Phase 3 clinical trials, with Molecular Partners as sponsor of those trials. Upon option exercise, Novartis would be responsible for all further development and commercialization activities. Molecular Partners is also collaborating with AGC Biologics, Baccinex, and Ivers-Lee Clinical Supply Management (IL-CSM) 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 ensovibep, if it is approved in Switzerland.

 

About Molecular Partners AG

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

For more information see www.molecularpartners.com and follow the Company on Twitter at @MolecularPrtnrs.

 

For further details, please contact:

Investors:
Seth Lewis
seth.lewis@molecularpartners.com
Tel: +1 781 420 2361

Media:
Shai Biran, Ph.D.
shai.biran@molecularpartners.com
Tel: +1 978 254 6286

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

 

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