Nanoform Finland Oyj : Interim Report January – March (Q1) 2021
05/27/2021 | 03:19am EDT
Nanoform's January-March 2021 review:
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 mil- lion).
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 sig- nificantly faster absorption when compared to the ref- erence 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 Nano- form'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 absorp- tion data from the second part of the study implied that nanoforming might offer viable alternatives to com- plex formulation approaches such as cyclodextrin based technologies.
In February, Nanoform appointed Dr Jamie Unwin as Commercial Insights Officer, based in Oxford UK, start- ing 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 experi- mental results from its CESS® nanoparticle engineer- ing 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 success- ful new share issue through an accelerated bookbuild- ing process. The considerably oversubscribed capital raise attracted strong interest from Nordic and inter- national 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 com- missioned. 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-basedthree-dimen- sional printing pharmaceutical company, announced that they are exploring the synergies between their respective technologies in the field of nanoparticle-en- abled 3DP dosage forms. The collaboration targets to combine Nanoform's fast dissolution nanoformed par- ticles 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.
Interim report | January-March 2021
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® tech- nology 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 pharma- ceuticals 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 technol- ogies 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, leverag- ing each organization's unique formulation expertise.
Nanoform Q1/2021 Conference Call on May 27th at 3.00 p.m. Finnish time (2.00 p.m. Swedish time)
Nanoform Finland Plc ("Nanoform"), an innovative nanoparticle medicine enabling company, will publish its Q1/2021 report on May 27, 2021, at 8.10 a.m. Finnish time / 7.10 a.m. Swedish time.
The company will hold a conference call and an online presentation on the same day at 3.00 p.m. Finnish time /
2.00 p.m. Swedish time. Nanoform will be represented by CEO Edward Hæggström, CFO Albert Hæggström and CBO Gonçalo Andrade. The presentation will be delivered in English.
Number of new customer projects started during the period
Number of lines (end of the period)
Number of employees (end of the period)
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 cus- tomer 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
Interim report | January-March 2021
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 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 com- missioned, 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 exe- cuted.
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.
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 biotech- nology 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 abil- ity, 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.