OREXO AB SP/ADR - ORXOY STOCK NEWS

Orexo has initiated a new clinical study (OX640-002) for OX640, an intranasal rescue medication for severe allergic reactions using powder-based epinephrine. The study will evaluate OX640's performance in 30 participants with allergic rhinitis through a cross-over design with four treatment periods. This follows positive phase 1 results where OX640 showed comparable absorption and effects to intramuscular auto-injectors.

The study will assess epinephrine absorption with and without allergic symptoms, comparing it to a commercial intramuscular product. The study cost is estimated at SEK 11 million, with completion expected in 2024 and results in early 2025.

Orexo reported Q3 2024 financial results with total net revenues of SEK 136.5m, down from SEK 156.1m in Q3 2023. The company posted a negative EBITDA of SEK -0.7m, improving from SEK -9.5m last year. US Commercial segment revenues declined to SEK 131.0m from SEK 140.4m. Net earnings deteriorated to SEK -41.9m from SEK -33.3m. The FDA requested additional technical data for OX124, their high-dose naloxone rescue medication. Despite challenges, including higher legal costs and lower Zubsolv sales, the company maintained its 2024 financial guidance and initiated a phase 1 study for OX640 in allergic rhinitis patients.

Orexo has announced the formation of its Nomination Committee for the Annual General Meeting (AGM) scheduled for May 8, 2025. The committee comprises four members: Henrik Kjaer Hansen (Chairman, appointed by Novo Holdings A/S), Claus Berner Møller (appointed by The Danish Labour Market Supplementary Pension, ATP), Stefan Hansson (private investor), and James Noble (Chairman of the Board of Orexo).

The Nomination Committee represents approximately 34 percent of the company's voting rights as of August 31, 2024. Their responsibilities include preparing proposals for the AGM regarding the Chairman of the meeting, Chairman of the Board, Board members, fees, auditor fees, and principles for the Nomination Committee's composition. Shareholders can submit proposals to the committee via email by March 7, 2025.

Orexo AB (STO: ORX) (OTCQX: ORXOY) has announced its participation in Pareto Securities' 15th Annual Healthcare Conference on September 19, 2024, at Downtown Camper by Scandic in Stockholm, Sweden. The company's SVP and Head of R&D, Robert Rönn, will deliver a company presentation from 2:25-2:45 CET in the Event Small room.

Additionally, Robert Rönn and Lena Wange, Investor Relations, will be available for one-on-one meetings during the conference. This event provides an opportunity for Orexo to showcase its developments and engage with investors and industry professionals in the healthcare sector.

Orexo AB (ORXOY) released its Q2 2024 interim report, showing total net revenues of SEK 154.0 million, slightly down from SEK 157.7 million in Q2 2023. The company reported an EBITDA of SEK 5.0 million and net earnings of SEK -35.9 million. US Commercial segment net revenues increased to SEK 147.9 million. Notably, Orexo received a complete response letter from the FDA for OX124, its high-dose naloxone rescue medication for opioid overdose, requesting additional data. The company successfully conducted a new human factor study in early July. Orexo's CEO highlighted a strong recovery in Zubsolv sales and the company's focus on bringing OX124 to the US market, despite the delay in FDA approval.

Orexo AB (STO: ORX) (OTCQX: ORXOY) has received a complete response letter (CRL) from the FDA regarding the New Drug Application (NDA) for OX124, a high-dose naloxone rescue medication for opioid overdose. The FDA requires an additional Human Factors (HF) study and more technical data on the final commercial product. No additional clinical or non-clinical studies are needed.

Orexo has already completed a new HF study successfully. The company will work quickly to address the unexpected request for additional technical data. The NDA resubmission review period will be up to six months. OX124 aims to meet the growing need for more powerful medications to reverse overdoses caused by synthetic opioids like fentanyl, which account for 92% of all fatal opioid overdoses.

Orexo AB has achieved a Gold Sustainability Rating from EcoVadis, placing it in the top 5% of the 70,000 businesses reviewed annually. This recognition is based on the company's sustainability efforts in Sweden, covering headquarters functions, R&D, Regulatory Affairs, Quality & SHE, and Supply Chain. The rating highlights Orexo's success in environmental, labor and human rights, ethics, and sustainable procurement areas. CEO Nikolaj Sørensen emphasized that the company will continue to set ambitious sustainability goals to benefit patients, investors, the company, and society.

Orexo will release its Q2 2024 Interim Report on July 17, 2024, at 8 am CET. A presentation for analysts, investors, and media will follow at 2 pm the same day, featuring CEO Nikolaj Sørensen and CFO Fredrik Järrsten. The presentation will cover the latest developments and include a Q&A session. Interested parties can attend either via teleconference or webcast, with registration details and relevant links provided in the press release. Presentation materials will be available on Orexo's website under the Investors/Reports, Presentations section prior to the event.

Orexo AB (ORXOY) has successfully issued senior secured callable floating rate social bonds worth SEK 500 million with a tenor of four years. The company has applied for admission to trading of the bonds on Nasdaq Stockholm after having the listing prospectus approved by the Swedish Financial Supervisory Authority. The estimated first day of trading is around May 14, 2024.