OREXO AB SP/ADR - ORXOY STOCK NEWS

Orexo AB has submitted a New Drug Application (NDA) to the FDA for OX124, a nasal rescue medication aimed at reversing opioid overdoses, particularly from synthetic opioids like fentanyl. With opioid overdoses surpassing 81,000 annually in the U.S., the high-dose naloxone formulation of OX124 promises faster and more effective treatment, as demonstrated in pivotal studies. The product is expected to launch in H1 2024, potentially expanding the naloxone market significantly, which is currently valued at USD 300-500 million. OX124 is protected by patents until 2039.

Orexo announced its Q4 2022 results with total net revenues of SEK 156.1 million, up from SEK 144.0 million in Q4 2021, showing a positive 8.4% increase. The U.S. Pharma segment contributed significantly, with net revenues of SEK 142.6 million. However, EBITDA was SEK -53.1 million, and net earnings were SEK -91.8 million, reflecting substantial operational costs. Cash flow from operations was negative at SEK -48.9 million, with total cash and investments decreasing to SEK 351.9 million. Positive advancements include the first clinical study results for OX640 and the last patient enrolled in the MODIA trial. Financial outlook for 2023 was also provided.

Orexo announced the initiation of two exploratory feasibility studies utilizing its proprietary drug delivery platform, amorphOX^®, in collaboration with leading biopharmaceutical and vaccine companies. The studies follow the successful formulation of the Covid-19 spike protein, which exhibited excellent protein stability. amorphOX^® has shown significant improvements in stability and bioavailability compared to other technologies. The company aims to advance these projects into revenue-generating partnerships if feasibility is confirmed.

Orexo has released its Q3 2022 financial highlights, reporting total net revenues of SEK 161.0 million, up from SEK 145.9 million year-over-year. EBITDA improved to SEK -32.4 million compared to SEK -47.4 million previously. The US Pharma segment saw revenues of SEK 150.1 million. Cash flow from operations was SEK -60.7 million, with total cash and invested funds at SEK 443.9 million, down from SEK 588.1 million. A clinical study for OX640 was initiated, and positive data was announced thereafter.

Orexo AB (OTCQX: ORXOY) has announced the completion of participant enrollment in a pivotal study of its digital therapeutic, MODIA®, intended for treating opioid use disorder (OUD). This study involves 437 participants across 35 sites in the US and aims to evaluate MODIA® in combination with sublingual buprenorphine/naloxone against buprenorphine/naloxone alone. Orexo emphasizes its deep expertise in the OUD market, having worked extensively with their product, ZUBSOLV®, over the past nine years. The study's results are expected to support FDA clearance.

Orexo AB (OTCQX: ORXOY) has appointed Dr. Edward (Ed) Kim as the new Chief Medical Officer, succeeding Dr. Michael Sumner. Ed Kim, who has a strong background in psychiatry and over 16 years in the pharmaceutical industry, will lead US Medical Affairs and enhance collaboration with Orexo’s Swedish team. His focus will be on innovative treatments for substance use disorders and mental health. This leadership change highlights Orexo’s commitment to developing effective solutions in a critical therapeutic area.

Orexo has appointed a Nomination Committee ahead of its Annual General Meeting (AGM) scheduled for April 18, 2023. The committee includes Christian Salling, Claus Berner Møller, Patrik Walldov, and James Noble, representing approximately 38% of voting rights as of September 30, 2022. The committee will propose key governance decisions, including the Chairman of the Meeting and Board members' remuneration. Shareholders can submit proposals to the Nomination Committee until February 17, 2023. Orexo specializes in pharmaceuticals for substance use disorders, with notable sales of SEK 565 million in 2021.

Orexo announced positive results from its first human clinical study (OX640-001) for OX640, a nasal epinephrine rescue medication for allergic reactions. The study, involving 40 healthy volunteers, demonstrated that all four investigational formulations achieved clinically relevant plasma levels of epinephrine rapidly, outperforming the current standard. With a target market exceeding USD 2 billion and expected annual growth of 8-9%, Orexo plans to pursue partnerships for the further development and commercialization of OX640, leveraging its patented amorphOX® platform.

Orexo AB (OTCQX: ORXOY) has partnered with Trinity Health to enhance patient access to its digital therapeutics, vorvida® and deprexis®. The collaboration establishes a collaborative care model, educating over 50 healthcare professionals to integrate these therapies, which aim to assist patients dealing with depression and excessive drinking. Trinity Health serves over 200,000 people across North Dakota and Eastern Montana, addressing significant mental health and substance use issues in these regions. This partnership marks a significant step in expanding access to evidence-based psychosocial support.