Strong momentum continues: three new non-GMP lines commissioned, four new clients signed, and six new customer PoC projects commenced. In addition, positive results from first clinical study announced, two near-term business targets achieved (“First Biologics PoC in 2021” and “at least three new non-GMP lines in 2021”), next generation STARMAP® launched, EUR 40 million successfully raised and commercial teams in the US and the UK further strengthened.

1-3/2021 key financials

  • Revenue EUR 278 thousand, growth + 85%, stemming from 14 different customer projects (EUR 150 thousand, 6 customer projects in 1-3/2020).
  • The gross profit and gross margin improved to EUR 243 thousand and 88%, respectively (EUR 103 thousand, 68%).
  • EBITDA improved to EUR -3.925 million (EUR -4.136 million).
  • The operating loss was flat at EUR –4.362 million (EUR –4.365 million).
  • The loss for the period improved to EUR –4.270 million (EUR –4.588 million).
  • Basic EPS was EUR -0.06 (EUR -0.11).
  • The number of employees grew to 87 at the end of review period (50).
  • EUR 40.0 million (gross) was raised in a new share issue.
  • Cash position was EUR 94.8 million on March 31, 2021 (EUR 4.8 million).

Significant events during 1-3/2021

  • Early January, a new near-term business target was announced: “At least 12 new non-GMP and at least one GMP customer project in 2021”.
  • In January, Nanoform announced positive interim results from its clinical study. The interim results suggested that a nanoformed oral piroxicam tablet achieved significantly faster absorption when compared to the reference tablet from the originator Pfizer.
  • In February, Nanoform and Herantis Pharma Plc signed a Biologics Proof of Concept Agreement aiming to enhance nasal drug delivery to the brain of Herantis’ CDNF therapies for Parkinson’s disease using Nanoform’s proprietary biological nanoparticle technology. As a result, Nanoform achieved its near-term business target of “First Biologics PoC project signed in 2021”.
  • In February, a PoC agreement was signed with an East Coast US Biotech Company.
  • In February, Nanoform announced further positive interim results from its clinical study. The fast absorption data from the second part of the study implied that nanoforming might offer viable alternatives to complex formulation approaches such as cyclodextrin based technologies.
  • In February, Nanoform appointed Dr Jamie Unwin as Commercial Insights Officer, based in Oxford UK, starting in April.
  • On February 26, a new near-term business target was announced: “At least three new non-GMP lines in 2021 and two new GMP lines in 2022”.
  • In March, Nanoform and Nacuity Pharmaceuticals, a Texas-based clinical stage pharmaceutical company, signed a technology Proof of Concept agreement to enhance ophthalmic drug delivery of Nacuity’s NPI-001 and NPI-002 drug candidates.
  • In March, a PoC agreement was signed with a European Biotech Company.
  • In March, Nanoform launched the next generation of its STARMAP® artificial intelligence platform, v2.0. The technology utilizes sparse-data AI to augment experimental results from its CESS® nanoparticle engineering process with detailed expert knowledge, allowing reliable predictions to be made regarding partners’ potential success of nanoforming their drug molecules. STARMAP® is a digital version of the CESS® technology that enables in silico experiments in large quantities, creating fast predictions of which molecules should be nanoformed.
  • In March, EUR 40 million (gross) was raised in a successful new share issue through an accelerated bookbuilding process. The considerably oversubscribed capital raise attracted strong interest from Nordic and international investors, including a considerable number of large global Tier 1 institutional investors.
  • In March, Nanoform appointed Dr Chris Worral as VP Business Development US, based in San Diego, starting in May.
  • During 1-3/2021 three new non-GMP lines were commissioned. As a result, the near-term business target “at least three new non-GMP lines in 2021”, was achieved. The total capacity at the end of the quarter was 11 non-GMP lines and one GMP line.

Significant events after 1-3/2021

  • On April 6, at the AGM, the Board of Directors, chaired by Miguel Calado, was re-elected.
  • In April, Nanoform and Aprecia, a US-based three-dimensional printing pharmaceutical company, announced that they are exploring the synergies between their respective technologies in the field of nanoparticle-enabled 3DP dosage forms. The collaboration targets to combine Nanoform’s fast dissolution nanoformed particles with Aprecia’s ZipDose-technology platform for rapid disintegration to enable high performance buccal and oral delivery of medicines to patients where rapid absorption is essential.
  • In May, Nanoform announced the completion and final results of its clinical study. The primary, secondary and optional exploratory objectives of the study were all met. The results showed that Nanoform’s CESS® technology enabled development of a fast-acting piroxicam immediate release tablet formulation with more rapid absorption and improved drug delivery performance in comparison to a standard reference IR tablet. The study outcome confirmed earlier published interim results and support the clinical utility of Nanoform’s technology and its potential applicability for producing fast-acting dosage forms for poorly soluble drugs.
  • In May, Nanoform and a US listed metabolic pharmaceuticals company signed a collaboration agreement.
  • In May, Nanoform and Celanese Corporation, a global specialty materials company, announced plans to explore the synergies between their respective technologies in the field of nanoparticle-enabled drug delivery. The goal is to assess the utility of combining Nanoform’s nanoparticle platform technologies with Celanese’s VitalDose® EVA copolymer delivery technology for drug-eluting implants. The aims are to enable the development of next-generation drug delivery devices that support increased drug load and possess enhanced sustained release properties. Nanoform and Celanese intend to work on formulation development, leveraging each organization’s unique formulation expertise.

CEO’s review

A great start to 2021!

During Q1/21 Nanoform has continued to show strong momentum; two near-term business targets have been achieved (“First Biologics PoC project in 2021” and “at least three new non-GMP lines in 2021”), six new customer non-GMP projects have started (half of the full year target “at least 12 non-GMP projects in 2021”), four new customers have signed, three new non-GMP lines have been commissioned, exceptional individuals from all over the world have joined, EUR 40m have been raised (I explicitly thank all investors for the faith you have placed in the Nanoform team, the response we get from you during our roadshows is remarkable and energizing), the next generation of our STARMAP® artificial intelligence platform was launched and a clinical trial with great results was successfully executed.

Based on client interaction, sales pipeline, and after further strengthening our US & UK teams during this quarter, (our global commercial team is three times stronger than one year ago) I am confident that the strong commercial momentum will continue and foresee that the coming quarters will show accelerating top-line growth from the 85% annual growth achieved in Q1.

My focus is now on ensuring that Nanoform enters the next stage in its growth trajectory. By that I mean the world of GMP projects supplying material to clinical trials with the long-term vision to help one billion patients. We will at our Capital Markets Day next week on June 4, on the one-year anniversary since our IPO, update our mid-term targets to include the Biologics initiative. I look with confidence and excitement to the coming years.

None of this can be done without our amazing employees and great partners. My sincere THANK YOU to you all for your continued dedication to Nanoform and for the inspiring and innovative work for which we are known.

Best Regards,

Prof. Edward Hæggström, CEO Nanoform

 

P.S. A few words about biological drugs ahead of our CMD in relation to which our new mid-term 2025 targets including Biologics will be announced:

Treating human diseases has traditionally relied on small molecules, which due to their chemically well-defined nature, rather simple synthesis process, and small molecular size can be effective and will continue to remain a major therapeutic component. However, already some 45 years ago, advances in gene technology and biotechnology allowed production of proteins and other biological molecules in living cells using recombinant DNA technology. In addition to therapeutic proteins, biologics today also comprise nucleic acid (DNA and RNA) based therapies including gene therapy, gene editing, siRNA, and antisense therapies.

The recent development and success of biological drugs has been impressive. The industry has become versatile and is moving from antibody-focused production to gene and cell therapies, exosomes, bispecific antibodies, fusion proteins, and nanotechnology approaches. Of the more than 18,000 drugs in the pharma pipeline more than 40% are already biologicals. Despite their success, biologicals still face challenges: The cost of production is high, and there is a need to improve their pharmacokinetic and pharmacodynamic properties, namely their targeting ability, and to reduce off-target effects and side-effects.

Nanoparticles (NPs) are increasingly used to improve the pharmacokinetic properties and delivery of the drugs, leading to the development of new nanomedicines. NPs are often used as non-viral vectors for drug delivery to different cells and organs, including the brain. One such example is the oncology blockbuster, Abraxane, that relies on a human serum albumin nanoparticle as a carrier for paclitaxel amorphous nanoparticles. NPs can thus be tailored to encapsulate the drugs but can also be engineered so that the surface is modified to incorporate the drugs and to ensure the deposition of the drug containing nanoparticles at the cellular surface.

When placed inside or when attached to NPs, biological molecules are stabilized from enzymatic clearance and sequestration. Over the past years the industry has seen market approval of liposome-based NPs as a drug delivery system for nucleic acids and the growing number of gene therapy products in development indicate that this trend is picking up. These formulations are typically injectable and need to be made sterile, adding cost and complexity to the manufacturing of the product. There are advantages of converting injectable products (intravenous or subcutaneous) into oral solid dosage forms. Engineering a biological drug containing NP that can be directly compressed into a tablet or as a suspension for injection with a tailored release profile offers significant advantages in the drug delivery arena.

An exciting new approach that might facilitate this conversion is direct nanoforming of biologics. This may improve pharmacokinetic properties of the biologicals and may also allow creating carriers with completely new properties and enabling new drug modalities. Another important recent new modality development is combining messenger RNA (mRNA) with nano-sized carriers to deliver protein function to cells. Using chemically modified mRNA with improved NPs allows a wide spectrum of applications, including COVID-19 vaccines. Combining this approach with homing peptides and use of multiple mRNAs can be applied in biological drug development for CNS diseases where they are currently not applied. In the specific case of brain targeted therapies, the efficiency of NPs in delivering the drug, especially to the brain, mainly depends on the circulation time of NPs in the blood, ability to cross the BBB and reach the target cells that are largely defined by the NP size, composition, and surface functional groups.

Company near-term business targets for 2021 and 2022

  • First Biologics PoC project in 2021 (achieved in February)
  • At least three new non-GMP lines in 2021 (achieved in March)
  • At least 12 new non-GMP and at least one GMP customer projects in 2021
  • Two new GMP lines in 2022

Company mid-term business targets 2025 (unchanged)

  • To nanoform at least 50 new Active Pharmaceutical Ingredients (API) annually
  • To have in place 25 operating production lines of which 5 to 10 are expected to be GMP production lines
  • Over 90 percent gross margin
  • Approximately 200 employees
  • To be cash flow positive

Nanoform’s complete Q1/2021 Interim Report can also be found at: https://nanoform.com/en/financial-reports-and-presentations/

Nanoform Q1/2021 Interim Report conference call and online presentation May 27, 2021 at 3:00 p.m. Helsinki time / 2:00 p.m. Stockholm time

Nanoform will be represented by CEO Edward Hæggström, CFO Albert Hæggström and CBO Gonçalo Andrade. The presentation will be delivered in English.

The presentation will be broadcast live as a webcast available at:

https://financialhearings.com/event/13594

Teleconference dial-in numbers:

FI: +358 9 81710522

SE: +46 8 56642703

UK: +44 3333 009274

US: +1 833 8230587

For further information, please contact:

Albert Hæggström, CFO

albert.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

About Nanoform

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 5621 806. For more information, please visit www.nanoform.com.

Forward-Looking Statements

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.