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Regulatory press release

Nanexa publishes interim report for January – June 2023

Nanexa
Download the release

Strong preclinical progress with NEX-22, positive Phase 1 data with NEX-20 and several partner projects in preclinical evaluation

Significant events during the second quarter 2023

  • Nanexa AB announced in June that recruitment and dosing have been completed in the Phase 1 study involving NEX-20. Since December 2022, single doses of NEX-20 have been administered to healthy volunteers in three consecutive escalating dose groups. Pharmacokinetic profile, safety, and tolerability data have been collected for the final dose group, with results expected to be presented in the upcoming autumn.
  • Nanexa entered into an agreement with the contract research organization (CRO) Profil in Neuss, Germany, ahead of the upcoming phase I study involving NEX-22, a monthly depot of liraglutide intended for the treatment of type 2 diabetes and, eventually, obesity. Profil specializes in early clinical studies within the fields of diabetes and obesity, and enjoys a strong global reputation for its execution of clinical research in these indications.

Significant events after the end of the period

  • In August, Nanexa obtained pharmacokinetic data from the Phase 1 clinical trial with NEX-20 that confirmed previous preclinical results and showed a release profile of lenalidomide at various doses up to 21 days. Final safety and tolerability data are expected in October and local adverse events reported to date with NEX-20 have been limited and transient.
  • Nanexa AB announced that a preclinical study of NEX-22 in minipigs confirms 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.

Summary of the reporting period 1 April – 30 June 2023

  • Turnover amounted to: TSEK 7,655 (211)
  • Operating profit (EBIT) amounted to: TSEK -10,067 (-15,854)
  • Profit after tax amounted to: TSEK -9,951 (-16,224)
  • Earnings per share amounted to: SEK -0,16 (-0,32)
  • Cash flow for the period amounted to: TSEK -22,141 (-20,822)
  • Cash and cash equivalents at end of period: TSEK 38,358 (66,904)

Summary of the reporting period 1 January – 30 June 2023

  • Turnover amounted to: TSEK 15,828 (509)
  • Operating profit (EBIT) amounted to: TSEK -18,770 (-28,185)
  • Profit after tax amounted to: TSEK -18,553 (-28,594)
  • Earnings per share amounted to: SEK -0,31 (-0,56)
  • Cash flow for the period amounted to: TSEK -42,824 (-38,756)
  • Cash and cash equivalents at end of period: TSEK 38,358 (66,904)

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, 23 August at 11:00am CET
A live commentary with CEO David Westberg and Chairman Göran Ando will take place on August 23 at 11:00am via Infront Direkt Studios and viewers will have the opportunity to ask questions via chat.

The report commentary will be available here.

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).

This information is information that Nanexa is obliged to make public pursuant to the EU Market Abuse Regulation. The information was submitted for publication, through the agency of the contact persons set out above, at 2023-08-23 08:00 CEST.

Attachments


Nanexa Interim Report Jan Jun 2023

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