HELSINKI, May 30, 2024 /PRNewswire/ -- Manufacturing of GMP material in Project Nanoenzalutamide commenced. EU/US pivotal studies are planned to start in 4Q24, with the read-out in 1Q25. One or several license/commercial supply agreements are expected to be signed during 2H24. Fimea's two-day inspection of our new GMP QC laboratory and new GMP lines is set for June 11-12. Takeda presented results from their nanoformed Biologics PoC study at DDF in Berlin, a strategic partnership was announced with CBC of Japan, a Business Finland grant of EUR 4m was won and EUR 15m was raised in a new share issue to build GMP capability to produce solid oral dosage forms for clinical trials and to create up to a dozen new product kernels like nanoenzalutamide and nanoapalutamide to be licensed out in the coming years. The previously communicated business targets for 2024: "Increased number of non-GMP and GMP projects in 2024 vs 2023" and "Improved operating free cash flow in 2024 vs 2023" are reiterated. 1-3/2024 key financials Revenue came in at EUR 0.6 million, stemming from 22 different customer projects (EUR 0.7m, 24 projects in 1-3/2023). The number of employees increased to 166 (152). Total operating costs* grew by 25 % to EUR 6.5 million (EUR 5.2 million) due to options related non-cash costs, investments in spare parts & building an internal maintenance function in addition to costs from the nanoenzalutamide project. EBITDA came in at EUR -5.7 million (EUR -4.5 million). The operating loss was EUR -6.5 million (EUR -5.1 million). The operating free cash flow improved to EUR -6.0 million (EUR -6.2 million) Basic EPS was EUR -0.09 (EUR -0.06) Cash position was EUR 41.3 million on March 31, 2024 (EUR 63.0 million).* (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 bonds.***Cash position after the new share issue was EUR 54.7 m on April 30, 2024. CEO's review "Nanoform progresses on many fronts. Since our last report we have entered Japan by making a strategic partnership with CBC, Takeda presented results from their nanoformed biologics PoC study at DDF in Berlin, we won a Business Finland grant of EUR 4m to research and develop nanoparticle-enabled formulation platforms for oral, inhaled, long-acting injectable, and high-concentration subcutaneous injectable drug delivery and we raised EUR 15m in a new share issue to build GMP capability to produce solid oral dosage forms for clinical trials and to create up to a dozen new product kernels like nanoenzalutamide and nanoapalutamide to be licensed out in the coming years. Last, but certainly not least, in project Nanoenzalutamide, we have now started clinical manufacture related to the upcoming pivotal EU/US studies. The clinical trials are expected to commence in 4Q24 and the results are expected in 1Q25. 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 a revenue driver for Nanoform already in the upcoming years. We expect to execute one or several licensing/commercial supply agreements in 2024 and expect these to include customary payments already at signing and later when meeting developmental- and regulatory milestones. Long-term we expect to receive royalty payments based on sales when the product is on the market. Nanoenzalutamide is expected to progress via the ANDA*/Hybrid generic pathway and as such will need to show bioequivalence versus the originator product, Xtandi®. In the eyes of the regulators, bioequivalence typically 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 now actively pursue commercial licensing and marketing partners for the product together with our partners in the ONConcept® consortium. 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 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 hydrocarbon solvents.  Nanoform's CESS® process uses CO2 of recycled origin, and is organic hydrocarbon 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. In 2024 we need to manufacture nanoformed GMP material for the registration batches and the pivotal bioequivalence studies. When positive, the submissions of the dossiers should be in 2025-26, with the aimed 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. We now have an inspection date from Fimea. They will do a two-day inspection of our new GMP QC laboratory and our new GMP lines 2&3 on June 11-12. A successful inspection will expand our GMP capacity by more than 3x and will help our gross margin to return to the targeted 90%+. On the business development side we have made solid progress among large pharma, with a growing interest also in our biologics technology. The US biotech sector shows clear signs of increased activity levels. While our revenue development during the last year was unsatisfactory, I am confident - based on the clearly increased - by number and depth - discussions with large-, mid-sized pharma and biotech companies, that we will reach our 2024 targets of more projects signed and improved cash ...