Nanoform Finland Plc
November 15, 2021
05:05 p.m. Finnish time / 04:05 p.m. Swedish time
Nanoform signs GMP agreement and achieves near-term business target
Helsinki, Finland – Nanoform, an innovative nanoparticle medicine enabling company, today announced it has signed an agreement to manufacture GMP (Good Manufacturing Practice) nanoformed material for a European headquartered international company. This follows the Letter of Intent (LOI), signed between the parties in June 2021, to nanoform and develop, manufacture, and commercialize an improved version of a current blockbuster drug.
In Q3 Nanoform signed 6 new customer non-GMP projects, taking the total for the first nine months of 2021 to 14 signed customer non-GMP projects (10 in 2020, 2 in 2019). Nanoform has now achieved its near-term business target of “At least 12 new non-GMP customer projects and at least one new GMP customer project in 2021”. The company has therefore achieved all near-term business targets for 2021.
The value of the GMP and non-GMP projects are according to Nanoforms guided business model, €0.5m to €10m per GMP project and €0.05m to €0.5m per non-GMP project. The announced GMP agreement is for early clinical development and therefore in the lower end of the company GMP guidance range. The final contractual terms for commercialization will be negotiated as the project progresses.
Professor Edward Hæggström, CEO of Nanoform, commented: “Following our clinical results earlier this year, Nanoform now enters its next growth phase; manufacture of nanoformed clinical grade API’s (Active Pharmaceutical Ingredients) for our customers and partners. Our manufacturing expansion is on track and in the coming years we’ll have additional GMP lines in place, catering to our customers’ growing needs for nanoformed API’s”.
The information in the press release is information that Nanoform is obliged to make public pursuant to the EU Market Abuse Regulation. The information was sent for publication, through the agency of the contact persons set out above, on November 15, 2021, at 05:05 p.m. Finnish time / 04:05 p.m. Swedish time.
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Nanoform is an innovative nanoparticle medicine enabling company. Nanoform works together with pharma and biotech partners globally to provide hope for patients in developing new and improved medicines utilizing Nanoform’s platform technologies. The company focuses on reducing clinical attrition and on enhancing drug molecules’ performance through its nanoforming technologies and formulation services. Nanoform’s capabilities include GMP manufacturing, and its services span the small to large molecule development space with a focus on solving key issues in drug solubility and bioavailability and on enabling novel drug delivery applications. Nanoform’s shares are listed on the Premier-segment of Nasdaq First North Growth Market in Helsinki (ticker: NANOFH) and Stockholm (ticker: NANOFS). Certified Adviser: Danske Bank A/S, Finland Branch, +358 40 744 1900. For more information, please visit www.nanoform.com.
This press release contains forward-looking statements, including, without limitation, statements regarding Nanoform’s strategy, business plans and focus. The words may,” “will,” “could,” “would,” “should,” “expect,” “plan,” “anticipate,” “intend,” believe,” “estimate,” “predict,” “project,” “potential,” “continue,” “target” and similar expressions are intended to identify forward-looking statements, although not all forward-looking statements contain these identifying words. Any forward-looking statements in this press release are based on management’s current expectations and beliefs and are subject to a number of risks, uncertainties and important factors that may cause actual events or results to differ materially from those expressed or implied by any forward-looking statements contained in this press release, including, without limitation, any related to Nanoform’s business, operations, clinical trials, supply chain, strategy, goals and anticipated timelines, competition from other companies, and other risks specified in Nanoform’s prospectus published (on May 22, 2020) in connection with Nanoform’s initial public offering (the “Prospectus”) under “Risk Factors” and in our other filings or documents furnished to the Finnish Financial Supervisory Authority in connection with the Prospectus. Nanoform cautions you not to place undue reliance on any forward-looking statements, which speak only as of the date they are made. Nanoform disclaims any obligation to publicly update or revise any such statements to reflect any change in expectations or in events, conditions or circumstances on which any such statements may be based, or that may affect the likelihood that actual results will differ from those set forth in the forward-looking statements. Any forward-looking statements contained in this press release represent Nanoform’s views only as of the date hereof and should not be relied upon as representing its views as of any subsequent date.