Nanoform initiates GMP campaign for first-in-human trial of nanoformed drug by year end – ahead of schedule

Nanoform initiates GMP campaign for first-in-human trial of nanoformed drug by year end – ahead of schedule 

Helsinki, Finland – Nanoform Finland Plc (“Nanoform”), an innovative nanoparticle medicine enabling company will, in the fourth quarter of 2020, start the first ever human trial of a drug candidate nanoformed using Nanoform’s proprietary CESS^® technology. Dosing will begin before year-end 2020 (previously: in 2021) and results are expected before the end of Q2/2021. The clinical trial is a progression of Nanoform’s first GMP campaign, which the company has now initiated, and will be made in partnership with Quotient Sciences (“Quotient”), a leading provider of drug development and manufacturing solutions.

In the clinical trial, Nanoform will investigate the behavior of an oral immediate release (IR) nanoformed formulation of piroxicam, an anti-inflammatory drug. Nanoform will manufacture the nanoformed piroxicam active pharmaceutical ingredient (API), which will then be transferred to Quotient’s facilities in Nottingham, UK. Quotient will support the project by developing a standard drug formulation for the nanoformed piroxicam API and administering it to healthy volunteers. By partnering with an integrated drug product formulation and clinical research organization, the timeline from manufacturing to dosing is reduced. The study aims to support the potential development of fast-acting forms of piroxicam and other drugs by demonstrating the clinical utility of Nanoform’s CESS^® nanoforming technology.

Nanoform’s in vivo and in vitro results suggest that by significantly reducing the size of drug particles, Nanoform’s CESS^® nanoforming technology can improve the pharmacokinetic properties of piroxicam. Poor bioavailability and solubility are major causes of failure in the drug development pipeline.

Nanoform is on track to achieve all its near-term business targets for 2020 and 2021 announced in relation to the IPO. “Start of first GMP project before end of 2020” has now been achieved, and “first dosing in humans in 2021” is on track to be already achieved in 2020 (previously: in 2021).

“The commencement of the first ever human trial of a drug nanoformed using our proprietary CESS^® technology is something we have been working tirelessly toward for many years, and we are very proud that our hard work has paid off in making the trial a reality ahead of schedule,” said Professor Edward Hæggström, Nanoform’s CEO.

“Over the years, we have conducted hundreds of development programs on new drug candidates and we are incredibly pleased to be supporting Nanoform to validate their CESS^® technology,” said Mark Egerton, CEO of Quotient Sciences. “We are committed to helping our customers bring new medicines to patients and eagerly await the outcome of the trial.”

Telephone conference for analysts, investors and media:

In connection with this release Nanoform will hold a telephone conference call Wednesday October 21^st at 10.45 a.m. Helsinki time (09.45 a.m. Stockholm time).

Nanoform will be represented by CEO Edward Hæggström, CFO Albert Hæggström, Head of Manufacturing David Rowe, CTO Niklas Sandler, CCO Christian Jones, CBO Gonçalo Rebelo de Andrade and Director of Investor Relations Henri von Haartman.

Please call 5–10 minutes prior to the event for a prompt start. Participants dial in:

Nanoform, Audiocast pressconference, October 21^st, 2020 at 10.45 Helsinki time

Language: English

Activity: Audiocast pressconference

Teleconference dial-in numbers:

FI: +358923195172

SE: +46856642704

UK: +443333009261

US: +18335268398

Webcast: https://financialhearings.com/event/13197

For further information, please contact:

Prof. Edward Hæggström, CEO

edward.haeggstrom@nanoform.com / +358 29 370 0150

For investor relations queries, please contact:

Henri von Haartman, Director of Investor Relations

hvh@nanoform.com / +46 7686 650 11

Certified Adviser: Danske Bank A/S, Finland Branch, +358 40 562 1806

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 October 20^th, 2020 at 05:15 p.m. Finnish time.

About Nanoform

Nanoform is an innovative nanoparticle medicine enabling company. Nanoform works together with pharma and biotech partners globally to reduce attrition in clinical trials and enhance their molecules’ formulation performance through its nanoforming services. The Company’s patented and scalable Controlled Expansion of Supercritical Solutions (CESS^®) technology produces nanoformed API particles as small as 10nm. This enables poorly soluble molecules in the pharmaceutical pipeline to progress into clinical development by increasing their rate of dissolution and by improving their bioavailability. Nanoform’s unique technology provides novel opportunities in many value-enhancing drug delivery applications. Nanoform’s share is listed on the Premier-segment of Nasdaq First North Growth Market in Helsinki (ticker: NANOFH) and Stockholm (ticker: NANOFS).

For more information please visit http://www.nanoform.com