Nanoform Finland Oyj: Nanoform 2024 report: Deal discussions around product kernels intensify

Company Announcement

Nanoform Finland Plc

February 27, 2025

08:10 a.m. Finnish time / 07:10 a.m. Swedish time

Nanoform 2024 report: Deal discussions around product kernels intensify

After a strong second half, 2024 showed a record number of new projects signed. Revenue growth is back and is expected to continue in coming quarters and years. Other operating income (incl. product kernel milestones) is also expected to grow. Manufacturing of GMP material for pivotal studies and registration batches in Project Nanoenzalutamide has continued in a 3-shift pattern, pivotal studies will start early 2Q25, with first read-out in the same quarter. The dealmaking discussions around our product kernels has intensified and we expect to sign deals on our first three product kernels (Nanoenzalutamide, Nanoapalutamide and Nanoencorafenib) in the coming weeks and months. Company mid-term business targets 2030 to be announced during 2025 in conjunction with Capital Markets Day.

10-12/2024 key financials

• Revenue grew by 87% to EUR 0.8 million, compared with EUR 0.4 million in 4Q23.

• The gross profit almost doubled to EUR 0.6 million, as the gross margin rose to 82% (EUR 0.3 million, 74%).

• Total operating costs* increased by 12% to EUR 6.5 million (EUR 5.8 million).

• The number of employees grew by 10% to 181 (165) compared with one year ago.

• EBITDA was flat at EUR -5.4 million (EUR -5.4 million).

• The operating free cash flow came in at EUR -5.9 million (EUR -5.9 million).

• Basic EPS was EUR -0.07 (EUR -0.07).

• Cash position** was 41.5 million on December 31, 2024 (EUR 47.5 million).
  

1-12/2024 key financials

• Revenue came in at EUR 2.8 million, stemming from 43 different customer projects (EUR 2.6 million, 33 projects in 1-12/2023).

• The gross profit was EUR 2.2 million, with a gross margin of 80% (EUR 1.7 million, 67%), impacted by external GMP QC costs related to the nanoenzalutamide project.

• The number of employees grew to 181 (165).

• Total operating costs* increased by 11% to EUR 24.7 million (EUR 22.2 million).

• EBITDA came in at EUR -21.0 million (EUR -19.6 million).

• The operating loss was EUR -24.2 million (EUR -22.5 million).

• The operating free cash flow improved to EUR -22.6 million (-23.1 million).

• Basic EPS was EUR -0.28 (EUR -0.26).

(Numbers in brackets refer to the corresponding last year reporting period, unless otherwise mentioned.)

* Defined as materials & services expenses, employee benefit expenses, and other operating expenses.

** Including Treasury bills. Part of the cash has been invested in short-term government bond.

CEO's review

Nanoform continues to progress on many fronts. After six quarters of negative revenue growth (1Q23-2Q24), we have seen strong momentum during the last two quarters and we expect this to continue in the coming quarters and years. The growth will be fuelled not only by a growing number of non-GMP projects and GMP projects - both in the small molecules and biologics - but also from development, exclusivity and milestone payments and later on from commercialization fees and royalties related to our technology offerings and product kernels.

During 2024 we signed another yearly record number of new projects, with especially the second part of the year showing strong momentum. I am pleased by the fact that our Biologics technology offering is starting to get the attention it deserves. Another area where we see a lot of attention globally is around our product kernels. The deal negotiations around nanoenzalutamide, nanoapalutamide and nanoencorafenib are progressing well, and we expect to sign deals with development partners and commercialization partners in the coming weeks and months.

Manufacturing of GMP material in project Nanoenzalutamide has been extended into a three shift pattern during 4Q. The scale-up from last year's campaign for the pilot study has been close to 100x in the ongoing manufacturing campaign for the upcoming pivotal studies and registration batches. This is a fantastic achievement by our manufacturing staff! On the R&D side we have again demonstrated a further improvement in the production rate, which lays a path for nanoforming to become a cost leader compared with other technologies in the coming years.

We expect nanoenzalutamide to be the first nanoformed medicine to reach the market - with a planned launch in 2027/28 in the US/EU - and to be an income driver for Nanoform already in the upcoming years. Nanoenzalutamide is expected to progress via the ANDA*/Hybrid generic pathway and as such will need to show bioequivalence vs the originator product, Xtandi®. In the eyes of the regulators, bioequivalence means 80% - 125% of the Cmax and AUC in a large cohort study in fed and fasted states with a 90% confidence interval. * ANDA=Abbreviated New Drug Application

The global annual sales of Xtandi® is presently USD 6bn and growing. We plan for nanoenzalutamide to take a meaningful share of this market through its highly patient centric product differentiation (1 tablet vs 4 tablets) and unique IP position (different technology, crystalline product, different excipients), while not forgetting its green attributes. We see the program to be attractive to value added medicine companies as a uniquely differentiated and high value supergeneric product that can enable a product launch before market entry by other generic products based on the ASD formulation, for which the originator currently holds patents in both Europe and the US (with expiry dates in 2033). For the originator company we believe that the nanocrystalline single tablet product offers a patient centric life cycle extension opportunity with compelling sustainability advantages that would be difficult for generic competitors to match. Avoiding the inherent stability challenges associated with amorphous materials is also a clear benefit for any company considering alternative formulation approaches.

Xtandi-tablets are formulated using a solubility-enhancement spray drying process to create an amorphous solid dispersion. The major challenge with spray drying is that the process often requires large amounts of undesirable and toxic organic solvents. Nanoform's CESS® process uses CO₂ of recycled origin, and is organic solvent-free, offering a greener alternative to medicine developers that seek to be both patient- and planet-centric. Nanoform continuously improves the CESS® technology, e.g. by planning to further recycle the CO₂ used by the process to become a carbon sink. This is an attractive proposition for the pharma industry to achieve its ambitious net zero goals. There are already concerns in the industry that industrial approaches with a heavy carbon footprint, e.g. spray drying, may lose their relevance in the future because of their environmental burden.

The timelines for the commercial launch of nanoenzalutamide are demanding, but achievable. First, we need to manufacture nanoformed GMP material for the registration batches and the pivotal bioequivalence studies. When positive, the submissions of the dossiers will follow, with the aimed product launch after the expiry of the enzalutamide substance patent in the respective territories (2027/28, US/EU).

During the past year we have worked on more than 40 different customer projects. These cover both small molecules and biologics, and range across multiple therapy areas and delivery methods. I remain encouraged by the diversity of our nanoparticles and nanoformulations. Not all customer projects progress - for a whole host of reasons - but the momentum I see in many of these projects makes me confident that we will also see some of these ongoing customer projects enter the clinic in the upcoming quarters and years. This also serves as testament to our strategy to work with many different companies and APIs, and not become dependent on any single project.

For Nanoform the last years have been about making large investments and building a capable organization. The coming will be about preparing to launch nanoformed products together with partners onto the global markets. We are ready for the challenge. I look forward 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're known.

Best Regards,

Prof. Edward Hæggström, CEO Nanoform

Attached to this press release are Nanoform's Financial Statement Review 2024, Report of the Board of Directors and Financial Statements 2024, Corporate Governance Statement 2024, Renumeration Report for Governing Bodies 2024 and Hallituksen Toimintakertomus ja Tilinpäätös tilikaudelta 2024. All these can also be found at: https://nanoform.com/en/media-center/press-releases/

Nanoform online presentation and conference call February 27, 2025, at 3:00 p.m. Helsinki time / 2:00 p.m. Stockholm time:

The company will hold an online presentation and conference call 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, CCO Christian Jones and General Counsel/CDO Peter Hänninen. The presentation will be delivered in English.

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

https://nanoform.events.inderes.com/q4-report-2024

Teleconference dial-in numbers:

Dial-in number to the teleconference will be received by registering via the link below. After the registration you will be provided phone numbers and a conference ID to access the conference. Questions can be presented by this dial-in function.

https://conference.inderes.com/teleconference/?id=5003370

Company near-term business targets for 2025

• To sign development and license/commercial supply agreements on several product kernels during 2025

• First pivotal bioequivalence study with nanoformed medicine

• Increased number of non-GMP and GMP projects signed in 2025 vs 2024
• Improved free cash flow in 2025 vs 2024

Company mid-term business targets 2030

• To be announced during 2025 in conjunction with Capital Markets Day

Our nanocrystalline alternatives to ASDs (amorphous solid dispersions)

Nanoenzalutamide, Nanoapalutamide, and as the latest addition Nanoencorafenib, are opportunities for us to show that small is a powerful ingredient in formulation. Due to the inherent poor solubility of the API, the current formulation of these medicines has been an amorphous solid dispersion ("ASD"). Amorphous API materials are unstable, and therefore require high amounts of polymers to stabilize the API - leading to a low drug load in the product and therefore, in the case of oral solid products, often to a high number of large tablets that need to be taken by the patient. This is a known problem, in particular for patient populations with challenges to swallow. The nanocrystalline formulations developed by Nanoform offer an attractive alternative with a substantially higher drug load in the final drug product and consequently a reduced tablet burden for the patient.

In Project Nanoenzalutamide, the manufacturing of the nanoformed drug substance for the pivotal study has progressed well and we have delivered already in excess of 50kg of material to our partner. We expect the clinical study to start in early 2Q 2025, with first read-out in late 2Q 2025. Project Nanoapalutamide is also progressing to plan. Following the positive results from the in vivo study comparing Nanoform's tablet prototypes with the currently marketed product, we have continued with the tablet development activities and are actively preparing GMP manufacturing activities and the pilot PK study in humans, which we expect to take place still in 2025.

We remain encouraged by the broad interest shown for these patient centric reformulations in key markets (among them US, Europe, and Japan) and are in ongoing discussions for all three products with potential development and commercialization partners. We expect to sign deals around these product opportunities during the coming weeks and months.

In addition to the patient benefit, we can with our proprietary technology offer opportunities to extend IP protection for the reformulated and improved product, expecting that in many cases our innovative formulations will be patentable. Importantly, current ASD based medicines are often protected by secondary patents that claim aspects of the ASD formulation. These secondary patents, such as in the case of the product in Project Nanoenzalutamide, often extend by several years the expiration of the primary patent claiming the API. In the case of Project Nanoenzalutamide, we believe that our nanocrystalline formulation is not in the scope of the patents claiming the ASD formulation. This should potentially enable entry earlier into the market, in the jurisdictions where the ASD formulation patents remain active, compared to ASD based generic formulations.

ASDs remain a leading formulation strategy for poorly soluble APIs, particularly for oral solid dosage forms. There are currently some 50 marketed medicines that are ASDs and these sell in aggregate for some USD 50bn annually in the world. We continue to actively look at several other opportunities in this field from products both in the market and in the global drug development pipeline. According to STARMAP®, almost 80 per cent of the 46 ASDs we so far have starmapped may be well suited to be nanoformed by CESS®.

Significant events during 1-12/2024

• On January 5, 2024, Nanoform announced it had completed the First Subject First Visit (FSFV) in a trial to evaluate the relative bioavailability of its nanocrystalline enabled alternative to an amorphous solid dispersion (ASD); formulation of nanoenzalutamide and Xtandi®^[1], the number one prescribed androgen receptor inhibitor^[2] first approved by the FDA in 2012 to treat prostate cancer. The single-dose, randomized, comparative bioavailability study, performed by a contract research organization in North America, compared enzalutamide 160 mg film-coated tablets (Bluepharma Farmacêutica S.A.) and Xtandi 4x40 mg film-coated tablets (Astellas Pharma Europe B.V.).

• On January 26, 2024, Nanoform announced that the relative bioavailability study of nanoenzalutamide had received promising clinical results. The nanoenzalutamide tablet formulation was developed in a partnership with the ONConcept® Consortium (Bluepharma, Helm, and Welding) whereby Nanoform's proprietary controlled expansion of supercritical solutions (CESS®) technology provides the opportunity for an improved and differentiated finished product. Tablet burden and dysphagia are well-documented challenges for prostate cancer patients, and the development of a 160mg, single tablet per day regimen may be preferable for patients in need of reducing their total number of daily pills. A patent application for the nanoenzalutamide formulation has already been jointly filed by Helm and Nanoform. The partners aim for product launch after the expiry of the enzalutamide substance patent in the respective territories. For the United States this patent expiry is expected in 2027, and in Europe in 2028. The unique IP position may allow the nanoenzalutamide product to enter the market prior to other generic competition based on the ASD formulation, which is currently patent protected in the US and Europe until 2033. [1] Xtandi® is a registered trademark of Astellas Pharma Inc. [2] Source: xtandi.com

• On February 15, 2024, Nanoform announced that it has won a grant of up to 4.3 million euros from Business Finland, the Finnish government organization for innovation funding and trade. The grant represents 50% of the costs associated with Nanoform's research and development project for nanoparticle-enabled formulation platforms for oral, inhaled, long-acting injectable, and high-concentration subcutaneous injectable drug delivery technologies for next generation medicines. The work is expected to take place during 2024 and 2025.

• On February 29, 2024, Nanoform announced it had received positive results from its own preclinical, in vivo study of a nanocrystalline-enabled apalutamide oral formulation, which shows potential to enable a much smaller tablet than Erleada®^[3], a nonsteroidal antiandrogen (NSAA) blockbuster amorphous solid dispersion (ASD) medicine used to treat prostate cancer.

[3] Erleada is a registered trademark for Apalutamide owned by Johnson & Johnson / Janssen Biotech Inc.

• On April 8, 2024, Nanoform announced that effective April 10, 2024, onwards, the Certified Adviser to Nanoform Finland Plc is Carnegie Investment Bank AB (publ). The Certified Adviser to Nanoform Finland Plc until April 9, 2024, was Danske Bank A/S, Finland Branch.

• On April 9, 2024, Nanoform announced a collaboration with PlusVitech, a biotechnology company developing treatments for cancer, to use Nanoform's state-of-the-art nanomedicine technology to repurpose the anti-nausea medicine aprepitant as a treatment for lung cancer. The development program will include nanoforming the current active ingredient into crystalline nanoparticles and formulating a simplified dose regimen with fewer and smaller pills. The partnership is expected to include API supply for late-stage clinical programs and eventual product launch. Following PlusVitech's positive first time in human studies, a Phase 2 study with 24 patients has commenced, investigating the efficacy of high dose aprepitant in a non-small cell lung cancer (NSCLC) population that is refractory to standard treatment. The current formulation carries a high pill burden of potentially dozens of capsules per day, with a complicated regimen for patients that are most often frail and have trouble swallowing (dysphagia). The new formulation by Nanoform is designed to deliver substantially higher drug load with better bioavailability, which simplifies the dose regimen and improves patient convenience and compliance. Re-purposing an existing drug offers a potentially faster, risk-reduced and cost-effective development path to new treatments for high medical need indications like NSCLC.

• On April 11, 2024, Nanoform announced a strategic partnership whereby CBC Co., Ltd. ("CBC"), will utilize its extensive experience in the Japanese pharmaceutical industry to identify opportunities for Nanoform's cutting-edge nanomedicine engineering technologies.

• Nanoform's Annual General Meeting (the "AGM") was held on April 16, 2024. 46 shareholders representing more than 60 per cent of all outstanding shares and votes were represented at the meeting. The Annual General Meeting supported all the Board of Directors' proposals. The AGM approved the financial statements and discharged the Board of Directors and the CEO of the Company from liability for the financial year 2023. The AGM further resolved the number of members of the Board of Directors to be four and the AGM re-elected Miguel Calado (Chairperson), Mads Laustsen, Albert Hæggström and Jeanne Thoma as ordinary members of the Board of Directors for the next term of office.

• On April 24, 2024, Nanoform announced that it had successfully completed a new share issue raising approx. EUR 15.4m by issuing 7m new shares (8.9% dilution) at EUR 2.20 (SEK 25.60) per share in order to invest in the commercialization of nanoparticle enabled formulations for next generation medicines. The placing attracted a considerable number of leading Nordic and international investors. The proceeds will be used to build a GMP level formulation facility to produce solid oral dosage forms for clinical trials, to development of up to a dozen preclinical nanocrystalline alternatives to ASD medicines ready for partnering in clinical trials and to co-fund several projects to be taken by Nanoform and its partners into clinical trials in the EU and the US, and ultimately through to the market.

• On May 22, 2024, at the 15th Global Drug Delivery & Formulation Summit in Berlin, Andreas Liebminger, Ph.D., Global Head of Plasma-derived Therapies Pharmaceutical Sciences, Takeda, presented data obtained in a proof of concept study, conducted in collaboration with Nanoform. Controlling the viscosity and aggregation of protein-based solutions is important for pharmaceutical formulators. Because injection volume is limited by the device, therapeutic protein formulations which are to be delivered via intramuscular or intravenous injection need to be highly concentrated. At protein concentrations greater than 200 mg*mL-1 however, viscosity increases to significantly higher than 20 cP (centipoise) to quickly exceed the maximum 40 cP viscosity deemed acceptable for a conventional subcutaneous injection. The data support the potential of Nanoform's patented biologics platform to achieve high protein concentrations in suspension formulations that are suitable for subcutaneous injection, as shown by results of syringeability and injectability studies.

• Nanoform has a shared facility license to nanoforming of Active Pharmaceutical Ingredients (APIs) for clinical trials. On June 11-12th, 2024 we had a pre-approval inspection from Fimea to upgrade our license to include new GMP facility and lines, GMP Quality Control laboratory (GMP QC), and the nanoforming of APIs to be used in drug products with a Marketing Authorization. The last part is a significant step, as our pharmaceutical manufacturing facility would then be allowed to manufacture for clinical trials and commercial drug products. Based on the pre-approval inspection, FIMEA suggested that Nanoform split the combined application into two independent applications: one for GMP QC and the other for the new GMP facility and lines, and commercial manufacturing, allowing for faster progression. We followed Fimea's suggestion and submitted the new GMP QC application.

• On June 14, 2024, a total of 85,072 new shares were subscribed for by the members of the Board of Directors. The shares were issued as part of remuneration of the members of the Board of Directors in accordance with the resolution by the AGM.

• On August 15, 2024 Nanoform announced that it has entered into a preclinical development agreement with the Plasma-derived Therapies Business Unit of Takeda Pharmaceuticals, Inc., the R&D-driven biopharmaceutical company headquartered in Japan, to develop innovative plasma-derived therapy formulations for the treatment of rare conditions. Following the completion of in vitro proof of concept studies of a novel plasma-derived therapy formulation, Nanoform will provide non-GMP nanomaterial to Takeda for in vivo studies. The first results of these studies are expected in early 2025.

• On August 19, 2024 Fimea informed us that they had approved our new GMP QC laboratory. As a result we started to transfer analytical activities from external laboratories into our own laboratory. This will have a positive impact on our gross margin and will improve our flexibility, control and cost position.

• In August, a new global major pharma customer was signed.

• On September 5, 2024 Nanoform announced an expansion of their collaboration with Celanese to cover biologic drug delivery. The companies will combine Nanoform's Biologics platform with the Celanese VitalDose® Drug Delivery platform to further optimize controlled release of biologics from long-acting, therapeutic implants. The collaboration will also include the further development of a long-acting, patient-centric implant for Multiple Sclerosis treatment.

• On December 17, 2024 The Board of Directors resolved to issue stock options to personnel of Nanoform. The total number of option rights to be issued is at most 1,099,593 which entitle to subscribe for at most 1,099,593 shares in Nanoform (stock-option program 1/2025). The subscription price for shares subscribed with stock options is EUR 1.40 per share.

For further information, please contact:

Albert Hæggström, CFO

[e-mail] / [phone]

For investor relations queries, please contact:

Henri von Haartman, Director of Investor Relations

[e-mail] / [phone]

About Nanoform

Nanoform is the medicine performance-enhancing company that leverages best-in-class innovative nanoparticle engineering technologies, expert formulation, and scalable GMP API manufacturing to enable superior medicines for patients. The company focuses on reducing clinical attrition and on enhancing drug molecules' performance through its nanoforming technologies and formulation services, from pre-formulation to commercial scale. Nanoform will help improve bioavailability and drug delivery profiles, drive differentiation, patient adherence and extend the lifecycle potential of products. 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: Carnegie Investment Bank AB (publ), [phone]. 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 described in the Report of the Board of Directors and Financial Statements for the year ended December 31, 2024 as well as our other past disclosures. 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.