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Orexo AB (ORXOY) reports developments for a Swedish pharmaceutical company whose U.S. security trades as ADRs on the OTCQX market. News centers on the company’s AmorphOX powder-based drug delivery technology, which is used to improve bioavailability and stability for small molecules, peptides and larger biomolecules, and on a diversified pipeline in clinical and preclinical development.
Recurring updates include R&D priorities following the U.S. Zubsolv divestment, organizational changes tied to product development, OX640 nasal epinephrine data for severe allergic reactions including anaphylaxis, intranasal formulation work with semaglutide, and collaborations for nasal powder vaccines. Company announcements also cover partner research, conference presentations and the parent company’s Nasdaq Stockholm listing alongside the ORXOY ADR program.
Orexo AB (publ.) has unveiled its novel drug delivery platform, amorphOXTM, which enhances the stability of amorphous drug compositions. This innovative powder technology allows for rapid drug dissolution and is suitable for various administration routes, such as nasal and sublingual. The platform has demonstrated effectiveness in in vivo studies and offers a competitive advantage for Orexo's first product, OX124, an overdose rescue medication. Several new patent applications have been filed to protect amorphOXTM until 2042.
Orexo AB (OTCQX:ORXOY) has successfully completed the pivotal trial for its lead drug candidate OX124, demonstrating faster absorption of naloxone compared to traditional methods. The trial met its primary endpoints, allowing the company to anticipate filing a New Drug Application (NDA) with the FDA in H2 2022, followed by a potential US launch in H2 2023. OX124 aims to address the rising opioid overdose crisis, which has seen over 96,000 overdose deaths in the US, predominantly from synthetic opioids. Orexo's innovative formulation positions it well in a growing market.
Orexo AB reported a challenging Q3 2021 with total net revenues of SEK 145.9 m, slightly down from SEK 150.3 m in Q3 2020. Net earnings were SEK -52.0 m, an improvement over SEK -84.9 m last year. The US Pharma segment generated net revenues of SEK 136.4 m (USD 15.8 m), while EBITDA remained negative at SEK -47.4 m. Operating cash flow also reported a decline of SEK -79.7 m. Positive highlights included a signed partnership with Sober Grid and the initiation of a pivotal trial for lead asset OX124. A commercial agreement was also established with Benefis Health System.
Orexo has established a Nomination Committee ahead of its 2022 Annual General Meeting (AGM), representing about 38% of the voting rights as of September 30, 2021. The committee includes members from Novo Holdings, ATP, and Orexo's Chairman, James Noble. It will propose key roles and remuneration for the upcoming AGM scheduled for April 21, 2022. Shareholders can submit proposals until February 18, 2022, for the Nomination Committee and until March 10, 2022, to address matters at the AGM. More details are available on Orexo's website.
Orexo announced the publication of a manuscript detailing the MODIA™ digital therapeutic for Opioid Use Disorder (OUD). Developed with GAIA Therapeutics, MODIA™ combines cognitive behavioral therapy with artificial intelligence to enhance treatment accessibility. Currently in a clinical evaluation phase, the study aims to assess MODIA™'s effectiveness alongside traditional medication-assisted treatment (MAT). The pivotal study will involve 400 participants across the U.S., focusing on reducing opioid use over 24 weeks. MODIA™ has not yet received FDA evaluation and may present unknown risks.
Orexo AB (OTCQX: ORXOY) announced on July 16, 2021, the initiation of the pivotal trial (OX124-002) for its naloxone rescue medication, OX124, designed to reverse opioid overdoses. The first cohort was dosed on July 15, 2021. This study compares OX124 to an injection reference product and is crucial for the New Drug Application in the US, with initial results expected in Q4 2021. The potential market for OX124 could grow from USD 300-500 million to USD 1.5-2 billion, with estimated sales potential of USD 70-110 million upon FDA approval.
Orexo's Q2 2021 results show net revenues of SEK 142.8 million, down from SEK 179.1 million year-over-year. Net earnings hit SEK -73.7 million, a decrease from SEK -32.5 million. The company reported an EBITDA of SEK -41.1 million, significantly lower than SEK -9.0 million in the previous year. However, ZUBSOLV® achieved net revenues of SEK 126.0 million in the US market. Key developments include new commercial agreements and the enrollment of the first patient in a pivotal study for modia™.
Sober Grid, a leading social media platform for addiction recovery, has partnered with Orexo to provide its users access to clinically validated digital therapeutics, vorvida® and deprexis®, starting August 2021. Vorvida® targets problematic alcohol use, while deprexis® addresses depression symptoms. These digital therapies utilize cognitive behavioral therapy and AI-driven personalization to enhance user experience. The collaboration aims to expand mental health accessibility, particularly for those hesitant to seek in-person treatment.
Orexo AB (OTCQX: ORXOY) has partnered with Sober Grid, enhancing access to its digital therapies vorvida® and deprexis® for over 300,000 users. The partnership aims to provide effective support for problematic alcohol use and depression. Available initially through Sober Grid's peer coaches in August 2021, the therapies will later be accessible to all users via the app, demonstrating Orexo's commitment to mental health support through innovative digital solutions.
Orexo AB (OTCQX: ORXOY) has enrolled the first participant in a pivotal study evaluating modia™, a digital therapeutic for opioid use disorder (OUD). This randomized study will assess modia™ combined with sublingual buprenorphine/naloxone for its effectiveness in reducing illicit opioid use, enrolling around 400 participants across the US. The opioid epidemic worsened during the COVID-19 pandemic, with over 67,500 fatalities linked to opioid overdoses. Orexo aims to address this gap in treatment options as part of their mission to improve substance use disorder responses.