Nanoform Q2 2026 - Positive feedback from scientific advice meeting in the UK, significantly improved cash flow and discussions with CDMOs on sterile GMP for our Biologics technology initiated

Nanoform Finland Plc | Company Release | August 20, 2026 at 08:10:00 EEST

Nanoenzalutamide project continues with the communicated multitrack strategy supported by all partners. After a positive scientific advice meeting with MHRA in the UK, we and our partners are on track to submit our first market authorization application for nanoenzalutamide before year end 2026. Discussions initiated with several CDMOs around potential sterile GMP manufacturing partnership for our ultra-high concentration biologics technology, fuelled by our first exclusivity deal. 2026 cash burn target on track as cash flow improved to EUR -1.5m in 2Q26.

4-6/2026 key financials

• Revenue grew by 16% to EUR 0.8 million, compared with EUR 0.7 million in 4-6/2025.
• The gross profit remained flat at EUR 0.7 million, with a gross margin of 84% (EUR 0.7 million, 98%).
• Total operating costs* decreased by -36% to EUR 3.9 million (EUR 6.1 million).
• The number of employees decreased by 38% to 108 (175) compared with one year ago.
• EBITDA improved to EUR -3.0 million (EUR -5.1 million).
• The operating free cash flow improved to EUR -3.4 million (EUR -5.2 million).
• Basic EPS was EUR -0.04 (EUR -0.07).
• Cash position was EUR 19.0 million on June 30, 2026 (EUR 33.3 million), EUR 1.5 million lower during the quarter.

1-6/2026 key financials

• Revenue grew by 33% to EUR 2.0 million (EUR 1.5 million).
• The gross profit grew to EUR 1.9 million, with a gross margin of 90% (EUR 1.4 million, 89%).
• The number of employees decreased to 108 (175).
• Total operating costs* decreased by 33% to EUR 8.2 million (EUR 12.3 million).
• EBITDA improved to EUR -6.0 million (EUR -10.0 million).
• The operating loss was EUR -7.5 million (EUR -11.6 million).
• The operating free cash flow improved to EUR -6.6 million (EUR -10.4 million).
• Basic EPS was EUR -0.08 (EUR -0.13).

(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.

CEO's review

During the months since our last quarterly report we have continued to make significant progress on our key objectives. These are to launch our first nanoformed product onto the global markets as soon as possible, to improve our cash flow while further improving the cost competitiveness of our technologies versus established ones, to get GMP status also for our biologics technology and to continue to work towards signing development and commercialization deals around our product kernels. All while continuing to make our nanoforming technologies more known and accepted in the global pharma industry.

On the first objective we received positive feedback from a recent UK MHRA scientific advice meeting. The purpose of the meeting was to receive advice on the applicability of the hybrid application pathway for a marketing authorization application for nanoenzalutamide in the UK with the existing clinical data package. A key outcome from the scientific advice was that a future UK marketing authorization application may be pursued via the hybrid application pathway, supported by the existing single dose bioequivalence studies and pharmacokinetic modelling. This means potentially a faster and less expensive route to launch. The UK MHRA will naturally consider the totality of the evidence package when reviewing the final dossier and it is important to remember that scientific advice given is not yet a market authorization. Regarding the nanoenzalutamide program in general, we are together with our partners continuing with our parallel multitrack strategy. We are evaluating selected national submissions in European markets that may accept the current data package (here we now got positive feedback from UK), with the aim of using such approvals as a basis for broader access over time. We are also advancing further formulation work to also meet the remaining Cmax requirement. These alternatives will require some additional spending on formulation work, but should not have a substantial cash flow impact on Nanoform, as we will continue to be paid for the work we perform. More important than the direct costs, are the potential impacts on timelines. Over the coming months and quarters, we expect to gain more clarity on expected timeliness through discussions with national authorities in Europe, feedback from the FDA, progress from formulation and preclinical/clinical work. Overall, all parties continue to see a meaningful global opportunity for nanoenzalutamide and its unique non-infringing formulation and believe the product can still reach the market potentially as early as 2028 and clearly before 2030.

We have been busy on many other fronts as well, which can be seen in the continued improvement in cash flow, where the cash burn improved to EUR 1.5m in 2Q and hence we are on track to reach our targeted cash flow improvement for the full year. Related to getting sterile GMP status for our biologics technology we have initiated discussions with several CDMOs to potentially place our technology in one of their existing facilities. The interest in our ultra high concentration biologics technology seems significant, with concrete feasible options on the table from reputable CDMOs. We will keep you informed how the discussions evolve.

For Nanoform the last years were about making large investments and building a commercially licensed world-class particle engineering factory. The coming years are about preparing to launch nanoformed products together with partners onto the global markets. We’re eager and ready for the challenge. I look forward with confidence and excitement to the next 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

Significant events during 1-6/2026

• In January, Nanoform announced change negotiations as part of the new midterm business targets for 2030.
• In February, Nanoform announced that it had concluded the change negotiations, as a result of which 49 employees were made redundant. The remaining personnel in Finland were also subject to temporary part-time layoffs starting from March 1, 2026, with a maximum duration of six months. The company estimates that these measures would result in cost savings of approximately EUR 5–6 million during 2026.
• In February, Nanoform announced the results from a preclinical study designed to compare the tolerability and pharmacokinetics of Nanotrastuzumab, a nanoformed, novel, hyaluronidase-free, non-aqueous nanoparticle suspension of trastuzumab for subcutaneous delivery versus Herceptin HYLECTA^TM, a co-formulated product with Halozyme’s proprietary hyaluronidase enzyme marketed by Roche/Genentech. Subcutaneous delivery of monoclonal antibodies, and other biological drugs, is the preferred delivery route due to patient convenience and healthcare system savings benefits. Limited availability of enabling delivery technologies has to-date constrained most biological drugs to be delivered as intravenous infusions. Nanoform’s proprietary particle engineering technology enables ultra-high concentration suspensions that may allow a substantial part of the biologics market to transition to subcutaneous and at-home delivery for patients. In a 21-day Göttingen minipig study run by Charles River Laboratories, Nanotrastuzumab’s AUC, Cmax and Tmax closely mirrored the reference product by Genentech / Roche. Nanotrastuzumab was well tolerated, supported by pathological, clinical and immunological readouts. Nanoform believes the data indicates that reference-like SC exposure may be achievable without hyaluronidase, expanding options for developers constrained by formulation, device, or IP/partnering considerations.
• In February, the Board of Directors of Nanoform decided to issue stock options to the personnel of Nanoform. The option program was open for participation by all employees at Nanoform on a voluntary basis as an alternative to the part-time layoffs announced by the company earlier. The total number of option rights to be issued is at most 1,813,698. The stock options entitle to subscribe for at most 1,813,698 shares in Nanoform. Each stock option entitles to subscribe for one new share. The subscription price for shares subscribed with stock options is EUR 0.83 per share. The total subscription price of the shares shall be paid to the company’s fund for invested own free equity.
• In March, Nanoform announced that it had been notified by its development partners of feedback from a recent European scientific advice meeting around nanoenzalutamide. The purpose of the meeting was to confirm the overall regulatory strategy for Europe and the acceptability of the clinical data package supporting a submission of nanoenzalutamide, in view of its demonstrated reduction in food‑effect, which resulted in a deviation from standard bioequivalence requirements. Following the meeting, the authority acknowledged the strong scientific rationale and high-quality standards for the product and the supporting data package. Current legal and regulatory requirements do not, however, allow a hybrid generic application for nanoenzalutamide in its present form, as full compliance with all bioequivalence criteria is mandatory. Consequently, the authority advised evaluating alternative legal bases (regulatory pathway and filing type) and clarified the criteria under which nanoenzalutamide is eligible to proceed via a generic approval pathway. As a result, the previously planned dossier submission slot in May was not met.
• Nanoform Finland Plc (the “Company” or “Nanoform“) held its Annual General Meeting for 2026 on April 21, 2026 at the Company's head office in Helsinki, Finland. 35 shareholders representing 35,594,748 shares and votes were represented at the meeting (41.5% of all outstanding shares and votes). The Annual General Meeting supported all the Board of Directors' proposals.
• In May, Nanoform announced that it had signed an exclusivity agreement with a U.S. biopharmaceutical company (Nasdaq listed, market cap USD 1Bn+) for the application of Nanoform’s proprietary biologics nanoparticle technology to support the development of differentiated subcutaneous biologic medicines. Under the agreement, the partner will pay Nanoform a non-refundable initial USD 1.0 million fee to secure exclusivity to license Nanoform’s biologics technology for one clinically and commercially validated target receptor for one year, with the right to extend once for an additional year against an additional non-refundable payment of USD 1.0 million. Subject to progression of the project with Nanoform by the partner, continued progress in establishing GMP-grade clinical supply by Nanoform, and entry into a license, the total aggregate milestones can be up to high tens of millions U.S. dollars, in addition to tiered royalties from low- to mid-single digits for sales of any successfully commercialized product utilizing Nanoform’s technology, in addition to potential separate payments for the services and supply of nanoformed product throughout development and commercialization.
• In May, the Board of Directors of Nanoform decided to issue stock options to key individuals. The total number of option rights to be issued is at most 420,000. The stock options entitle to subscribe for at most 420,000 shares in Nanoform. Each stock option entitles to subscribe for one new share. The subscription price for shares subscribed with stock options is EUR 1.70 per share. The total subscription price of the shares shall be paid to the company’s fund for invested own free equity.
• In June, a total of 85,000 Nanoform Finland Plc’s new shares have been subscribed for by the members of the Board of Directors. The shares are issued as part of remuneration of the members of the Board of Directors in accordance with the resolution by the Company’s Annual General Meeting April 21, 2026 (the “AGM”).

Significant events after 1-6/2026

• In August, Nanoform announced that it has been notified by its development partners of positive feedback from a recent UK MHRA scientific advice meeting. The purpose of the meeting was to receive advice on the applicability of the hybrid application pathway for a marketing authorization application for nanoenzalutamide in the UK with the existing clinical data package. A key outcome from the scientific advice was that a future UK marketing authorization application may be pursued via the hybrid application pathway (HMR Regulation 52B), supported by the existing single dose bioequivalence studies and pharmacokinetic modelling. The UK MHRA will consider the totality of the evidence package when reviewing the final dossier. Scientific advice given is not legally binding with regard to any future application for the product concerned, neither on the part of UK MHRA/Commission on Human Medicines (CHM) nor on the applicant and advice cannot be taken as indicative of any future agreed position.

Company near-term business targets 2026

• Cash burn below EUR 10 million
• First marketing authorization application for a nanoformed medicine submitted
• Increased number of non-GMP and GMP projects signed in 2026 vs 2025
• To sign development and license/commercial supply agreements on several product kernels during 2026

Company mid-term business targets 2026-2030

• 3 Nanoformed medicines launched by 2030
• Income* growth >50% CAGR** 2026-2030
• EBIT margin >30% by 2030

*Revenue + other operating income (milestones, fees, royalties, profit shares etc.)
**Compound annual growth rate

Nanoform’s Q2 2026 report and management presentation can be found at: https://nanoform.com/en/financial-reports-and-presentations/

Nanoform online presentation and conference call August 20^th, 2026, at 11:00 a.m. EET / 10:00 a.m. CET:

The company will hold an online presentation and conference call the same day at 11.00 a.m. EET / 10.00 a.m. CET. Nanoform will be represented by CEO Edward Hæggström, CFO Albert Hæggström, CCO Christian Jones and CDO & GC Peter Hänninen. The presentation will be delivered in English.

The presentation will be broadcasted live and participants may access the event via live audiocast and teleconference through the following link: https://investorcaller.com/events/nanoform/nanoform-q2-report-2026.

To participate in the event, attendees are required to register. To join the Q&A session, participants must dial in to the teleconference. After registering, they will receive a dial-in number, a conference ID, and a personal user ID to access the conference. Please note that questions can only be submitted through the teleconference line.

For further information, please contact:

Albert Hæggström, CFO
albert.haeggstrom@nanoform.com
+358 29 370 0150

Henri von Haartman, Director of Investor Relations
hvh@nanoform.com
+46 7686 650 11

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-clinical 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: DNB Carnegie Investment Bank AB, +46 8 588 685 70, certifiedadviser@dnbcarnegie.se. For more information, please visit www.nanoform.com. 

Nanoform 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, 2025 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.