-- Significant progress in COVID-19 trials, including positive results from healthy subjects and COVID-19 patients, supporting the launch of ongoing late-stage trials EMPATHY and ACTIV-3
Research & Development:
- Initiated two global Phase 2 and 3 trials of ensovibep (MP0420), to explore safety and efficacy in ambulatory patients with COVID-19 (EMPATHY) in collaboration with Novartis, and hospitalized patients (ACTIV-3) sponsored by the
National Institutes of Health (NIH) - Received FDA Fast Track designation for ensovibep for the treatment of COVID-19 in both hospitalized and ambulatory settings
- Initiated and fully enrolled Phase 2a single arm study of ensovibep in
the Netherlands in patients with mildly symptomatic COVID-19, with data expected to be presented in a scientific conference in H2 2021 - Reported that in vitro studies indicate that ensovibep maintains potency against all known SARS-CoV-2 variants of concern, including Delta and Lambda
- Presented data further supporting the MP0317, T-cell engager, and Peptide-MHC oncology programs at AACR
- In August, announced receipt of global rights of abicipar pegol for the treatment of neovascular AMD (nAMD) and Diabetic Macular Edema, following termination of license and collaboration agreement by AbbVie Inc.
Leadership & Governance:
- Elected
Agnete Fredriksen and Dominik Höchli to the Board of Directors at the Annual General Meeting ofApril 21, 2021
Financial highlights:
- Successfully completed initial public offering of American Depositary Shares (“ADSs”) on the Nasdaq, raising
$63.8 million (CHF 58.8 million ) in gross proceeds to support ongoing operations into H2 2023 - Ongoing strong financial position with
CHF 174.3 million in cash and short-term deposits as ofJune 30, 2021 - Net cash outflow from operating activities of
CHF 52.5 million in H1 2021 - FY 2021 expense guidance maintained at
CHF 65-75 million
“Molecular Partners strongly expanded our global clinical presence and collaboration with Novartis in the first half of the year as the evolving COVID-19 pandemic continued to underscore the need for effective antiviral therapeutics. As a now dual-listed company in
Antiviral program: Rapid development of trispecific antiviral DARPin® candidate ensovibep in multiple international clinical trials
In March of 2021,
In May of 2021,
In April of 2021, the first patient was dosed in a Phase 2a clinical trial of ensovibep in a single arm, open label study in
In
DARPin® molecules offer a differentiated approach to treating COVID-19 through a ‘cocktail in a molecule’ mechanism; a single molecule that can engage three domains of the SARS-CoV-2 virus simultaneously to inhibit viral entry into cells. This allows for a potentially broader efficacy and reduces the likelihood for the development of viral drug resistance which can result from selection pressure on any single molecular target. In addition, DARPin® candidates are produced through rapid, high-yield microbial fermentation for potential speed and logistical advantages over mammalian cell production employed for antibodies.
Based on the success seen to-date of ensovibep’s unique approach to neutralizing the virus,
Following the positive initial results of MP0310, clinical work advanced into weekly administration of MP0310 in the Phase 1 study, to identify a dosing regimen to obtain sustained 4-1bb activation.
In April of 2021,
With respect to MP0317, a multi-specific DARPin® product candidate targeting both FAP and CD40 to enable tumor-localized immune activation, new preclinical data showed activation of B-cells and myeloid cells in ex vivo human tumor samples. This demonstrated that physiological presence of FAP, expressed in the connective tissue of a broad range of solid tumors, is mandatory and sufficient for MP0317 to induce immune activation. Furthermore, the data presented at AACR shows that MP0317 led to a range of pro-inflammatory activities, including macrophage repolarization and reversion of T‑cell suppression only in the presence of FAP. In both assays the killing effect was comparable to that achieved by an anti-CD40 antibody. The Company believes these data support MP0317’s potential to deliver tumor-localized CD40-mediated immune cell activation while avoiding systemic toxicity seen with other agents. MP0317 is anticipated to begin clinical trials in the second half of 2021.
In preclinical studies, the Company’s AML research candidates demonstrated substantial activity against different populations of AML cells in vitro and ex vivo, without significant damage to healthy cells. The candidate is further designed to bind with increased avidity as the number of relevant antigens presented increases, further strengthening its preference for tumor cells. The candidate is a single molecule designed to target three different cancer antigens simultaneously (CD70, CD33, and CD123). This multi-specific DARPin® T-cell engager candidate is designed to deliver a highly potent and specific anti-tumor response to AML cells, with a reduced effect on healthy normal cells, and with the potential to counteract target escape mechanisms expected due to tumor heterogeneity. The AML DARPin candidate demonstrated potent induction of T-cell mediated cytotoxicity against AML cell lines and primary AML calls. In an ex vivo assay using fresh blood from healthy donors, the candidate induced profoundly less inflammatory cytokine production and reduction in platelet counts than T-cell engager candidates in development by other parties.
Molecular Partners’ T-cell engager programs also include a novel 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,
Finally, new data were presented supporting Molecular Partners’ peptide-MHC targeting program, which focuses on developing the capability to target cell surface protein complexes indicating disease through display of intracellular peptides. At AACR, the Company presented preclinical results demonstrating rapid and reliable generation of DARPin® proteins against a peptide-MHC complex (pMHC). These DARPin® proteins were then formatted into bispecific T-cell engagers, and engineered to enable potent and specific activation of T cells. Further, the results showed that a pMHC-targeting DARPin® candidate was able to achieve systemic half-life extension.
Ophthalmology
In August, the Company was updated by its collaboration partner, AbbVie Inc. of its termination of the license and collaboration agreement for the investigational drug abicipar pegol for the treatment of nAMD and DME. As such,
Financial Highlights: Nasdaq offering extends cash runway into H2 2023
The net cash outflow from operating activities during the first six months in 2021 was
Total shareholders’ equity stood at
KEY FIGURES AS OF
Key Financials (unaudited) | H1 2021 | H1 2020 | Change | ||||||
(CHF million, except per share, FTE data) | |||||||||
Total revenues and other income | 4.4 | 7.5 | (3.1 | ) | |||||
R&D expenses | (31.6 | ) | (25.1 | ) | (6.5 | ) | |||
SG&A expenses | (7.6 | ) | (5.5 | ) | (2.1 | ) | |||
Operating result | (34.8 | ) | (23.1 | ) | (11.7 | ) | |||
Net result | (33.6 | ) | (24.7 | ) | (8.9 | ) | |||
Basic net result per share (in CHF) | (1.13 | ) | (1.14 | ) | 0.01 | ||||
Net cash from (used in) operating activities | (52.5 | ) | (27.9 | ) | (24.6 | ) | |||
Cash balance (incl. time deposits) as of | 174.3 | 64.4 | 109.9 | ||||||
Total shareholders’ equity as of | 134.6 | 31.0 | 103.6 | ||||||
Number of total FTE as of | 158.3 | 143.6 | 14.7 |
BUSINESS OUTLOOK AND PRIORITIES
In the second half of 2021,
FINANCIAL OUTLOOK 2021
For the full year 2021, at constant exchange rates, the company continues to expect total expenses of
In terms of cash outflow the company expects a gross cash utilization of
With
DOCUMENTATION
The results presentation, this press release, and the half-year 2021 report will be made available on www.molecularpartners.com after
H1 2021 CONFERENCE CALL & AUDIO WEBCAST
In order to register for the H1 2021 conference call, please dial the following numbers approximately 10 minutes before the start of the presentation:
+41 800 83 6508 | |
USA | +1 844 865 3856 |
Participants in the conference call will have the opportunity to ask questions after the presentation.
AUDIO WEBCAST
The H1 2021 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
Interim Management Statement Q3 2021 | |
R&D Day in |
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
ABOUT
CAUTIONARY NOTE REGARDING FORWARD-LOOKING STATEMENTS
Any statements contained in this press release that do not describe historical facts may constitute forward-looking statements as that term is defined in the Private Securities Litigation Reform Act of 1995, as amended, including, without limitation, implied and express statements regarding the clinical development of Molecular Partners’ current or future product candidates, including timing for the potential submission of emergency use authorization for ensovibep, expectations regarding timing for reporting data from ongoing clinical trials or the initiation of future clinical trials, the potential therapeutic and clinical benefits of Molecular Partners’ product candidates, the selection and development of future antiviral or other programs, and Molecular Partners’ expected expenses and cash utilization for 2021 and that its current cash resources will be sufficient to fund its operations and capital expenditure requirements into H2 2023. These statements may be identified by words such as “anticipate”, “believe”, “could”, “expect”, “intend”, “may”, “plan”, “potential”, “will”, “would” and similar expressions, although not all forward-looking statements may contain these identifying words, and are based on Molecular Partners AG’s current beliefs and expectations. These statements involve risks and uncertainties that could cause actual results to differ materially from those reflected in such statements. Some of the key factors that could cause actual results to differ from our expectations include our plans to develop and potentially commercialize our product candidates; our reliance on third party partners and collaborators over which we may not always have full control; our ongoing and planned clinical trials and preclinical studies for our product candidates, including the timing of such trials and studies; the risk that the results of preclinical studies and clinical trials may not be predictive of future results in connection with future clinical trials; the timing of and our ability to obtain and maintain regulatory approvals for our product candidates; the extent of clinical trials potentially required for our product candidates; the clinical utility and ability to achieve market acceptance of our product candidates; the potential impact of the COVID19 pandemic on our operations or clinical trials; our plans and development of any new indications for our product candidates; our commercialization, marketing and manufacturing capabilities and strategy; our intellectual property position; our ability to identify and in-license additional product candidates; the adequacy of our cash resources and our anticipated cash utilization; and other risks and uncertainties that are described in the Risk Factors section of Molecular Partners’ Registration Statement on Form F-1 filed with
FOR FURTHER DETAILS, PLEASE CONTACT:Seth Lewis , SVP IR, Comms & Strategy seth.lewis@molecularpartners.com Tel: +1 781 420 2361Shai Biran , Ph.D., Associate Dir. IR & Comms shai.biran@molecularpartners.com Tel: +1 978 254 6286Thomas Schneckenburger , European IR & Media thomas.schneckenburger@molecularpartners.com Tel: +41 79 407 9952
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