Positive clinical and preclinical results, and secured financing with focus on NEX-22 and next steps in partner projects

Significant events during the third quarter 2023

  • Nanexa AB received pharmacokinetic data from the Phase 1 study NEX-20-01 confirming a release profile of lenalidomide in different doses up to 21 days and announced that final data on safety and tolerability will be announced later in the autumn.
  • Nanexa received results from a preclinical study of NEX-22 in minipigs confirming a long release profile of liraglutide, which was previously seen in rats. The data show that a release profile of NEX-22 can be obtained for at least 28 days, which was the duration of the pharmacokinetic study and the goal of the study.
  • Nanexa was granted a patent in India relating to its PharmaShell® technology. The patent covers the relevant manufacturing method, coated drug particles that result therefrom, and pharmaceutical composition containing those particles. The PharmaShell patent was already granted in the US, Japan, Korea, China, Canada and in European countries, and with the approval in India, Nanexa now has patents in all countries where it applied for patent protection.
  • On September 21, Nanexa announced that the company is conducting a rights issue of approximately SEK 121 million, which was secured by subscription commitments and guarantee commitments totaling SEK 75 million. The company also decided, as a result of the rights issue, to postpone the publication of the company's interim report for the period January - September 2023 to November 20, 2023.

Significant events after the end of the period

  • In October, Nanexa announced that the phase I study NEX-20-01 has been completed with the last follow-up visits for the last of the three dose levels studied. In addition to previously communicated positive results from the pharmacokinetic evaluation, the company has now also received final safety and tolerability data that also support the further development of the project.
  • On October 11, Nanexa published an EU growth prospectus in connection with the previously announced rights issue.
  • Nanexa announced on October 20 that the company has received additional subscription commitment of approximately SEK 4.7 million in the ongoing rights issue from one of the company's largest shareholders, Applied Materials Europe B.V., a company in the same group as Applied Ventures, LLC.
  • On October 30, Nanexa announced the outcome of the company's rights issue of approximately SEK 121 million, for which the subscription period ended on October 26. The outcome showed that 42,146,268 shares, corresponding to approximately 34.7 percent of the rights issue, had been subscribed with and without subscription rights. Thus, guarantee commitments of 32,853,732 shares, corresponding to approximately 27.1 percent of the offered shares, were utilized and the rights issue provides the company with SEK 75 million before transaction costs.

Summary of the reporting period 1 July – 30 September 2023

  • Turnover amounted to: TSEK 6,683 (1,531)
  • Operating profit (EBIT) amounted to: SEK -6,488 (-11,927)
  • Profit after tax amounted to: TSEK -6,694 (-12,045)
  • Earnings per share amounted to: SEK -0.11 (-0.24)
  • Cash flow for the period amounted to: TSEK -17,790 (-21,297)
  • Cash and cash equivalents at end of period: TSEK 20,569 (45,608)

Summary of the reporting period 1 January – 30 September 2023

  • Turnover amounted to: TSEK 22,511 (2,040)
  • Operating profit (EBIT) amounted to: TSEK -25,258 (-40,112)
  • Profit after tax amounted to: TSEK -25,247 (-40,639)
  • Earnings per share amounted to: SEK -0.42 (-0.80)
  • Cash flow for the period amounted to: TSEK -60,613 (-60,052)
  • Cash and cash equivalents at end of period: TSEK 20,569 (45,608)

Figures in brackets refer to the corresponding period in the previous year.

The entire report is available on the company’s website: https://nanexa.com/en/financial-reports/.

Report commentary, 20 November at 3:00pm CET

A live commentary with CEO David Westberg, CFO Björn Svanström and Chairman Göran Ando will take place on November 20 at 3:00pm via Infront Direkt Studios and viewers will have the opportunity to ask questions via chat. The presentation will be held in Swedish.

The report commentary will be available via this link.

The report comment will also be published on Nanexa's website afterwards.

For additional information, please contact:

David Westberg – CEO, Nanexa AB (publ) 
Phone: +46 70 942 83 03
Email: david.westberg@nanexa.se
www.nanexa.com
Erik Penser Bank is the company’s Certified Adviser and can be reached on +46 8 463 83 00, email: certifiedadviser@penser.se

About Nanexa AB (publ)

Nanexa is a pharmaceutical company developing injectable drug products based on the proprietary and innovative drug delivery system PharmaShell® – the high drug load delivery system enabling the next generation long-acting injectables through atomic layer precision. Nanexa develops its own products and also has collaboration agreements with several pharma companies, among others Novo Nordisk and AstraZeneca.

Nanexa’s share is listed on Nasdaq First North Growth Market in Stockholm (NANEXA).

Attachments

Nanexa Interim Report Jan Sep 2023

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