
Akyso Therapeutics Expands Pipeline with New NIH Grant for Buprenorphine Implant Following Successful Phase 1a Trial of Naltrexone Implant
The iSTEP products represent disruptive ultra long acting formulations of both naltrexone and buprenorphine and with them Akyso Therapeutics is poised to capture a large portion of the $3B OUD treatment market in the US.
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Key Highlights:
Phase 1a trial demonstrated that the iSTEP-N® implant was well-tolerated with no serious adverse events or implant-related complications.
Sustained therapeutic plasma levels of naltrexone were observed for three months following a single implant.
Residual Naltrexone content of the implant after 3-months suggests potential for 12-month efficacy.
The iSTEP® platform utilizes a proprietary, fully bioabsorbable polymer system that does not require surgical removal.
A Phase 1b study in patients with OUD is planned for early 2026 and will include a comparison to Vivitrol®.
$15 million NIDA grant awarded for the development of a 6-12-month extended-release buprenorphine implant, iSTEP-B®.
'We are thrilled to share not only the success of our Phase 1a iSTEP-N® trial, but also the launch of our buprenorphine implant program with support from NIDA,' said Steven Cohen, MD, FACS, co-founder and co-CEO of Akyso Therapeutics. 'This expanded funding and validation from the NIH will allow us to pursue our dual-track approach to transforming OUD treatment with both naltrexone and buprenorphine.'
Naltrexone and buprenorphine formulations represent over 90 percent of treatment options for OUD in the United States. The iSTEP products represent disruptive ultra long acting formulations of both naltrexone and buprenorphine and with them Akyso Therapeutics is poised to capture a large portion of the $3B OUD treatment market in the US. The new buprenorphine implant project builds directly upon Akyso's iSTEP® platform. iSTEP-B® will use the same bioabsorbable, subcutaneous delivery system as iSTEP-N®, with the goal of delivering therapeutic buprenorphine levels continuously for more than six months. The company plans to follow a similar clinical development pathway, including formulation, CMC analytics, GLP toxicology, and human trials.
'Our goal is to offer patients long-acting, discreet treatments that reduce relapse risk during the most vulnerable stages of recovery,' said Jeffrey Benner, MD, co-founder and co-CEO. 'With iSTEP-N® entering patient trials and iSTEP-B® now funded for development, we are well-positioned to provide scalable, very long acting, implantable therapies for both opioid and alcohol use disorders.'
Akyso's iSTEP-N® program is supported in part by NIDA (UH3DA048338). A description of the Phase 1a trial is available on ClinicalTrials.gov under the identifier NCT06053197. The new iSTEP-B® buprenorphine program is supported by a separate $15 million federal grant (2025–2029).
For more information on Akyso Therapeutics or partnership opportunities, please contact:
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Reconciliation of Selected GAAP to Non-GAAP Financial Measures (Unaudited, in millions, except percentages and per share amounts) Three Months Ended June 30, Six Months Ended June 30, 2025 2024 2025 2024 GAAP gross profit $ 1,438.6 $ 1,097.2 $ 2,714.7 $ 2,098.6 GAAP gross margin 65.2 % 64.9 % 64.5 % 64.3 % Stock-based compensation expense 5.8 4.0 11.3 7.4 Intangible asset amortization 2.6 4.2 5.8 8.4 Non-GAAP gross profit $ 1,447.0 $ 1,105.4 $ 2,731.8 $ 2,114.4 Non-GAAP gross margin 65.6 % 65.4 % 64.9 % 64.8 % GAAP income from operations $ 986.2 $ 699.6 $ 1,845.0 $ 1,359.7 GAAP operating margin 44.7 % 41.4 % 43.8 % 41.7 % Stock-based compensation expense 85.2 79.3 178.2 156.5 Intangible asset amortization 5.0 6.7 10.6 13.4 Non-GAAP income from operations $ 1,076.4 $ 785.6 $ 2,033.8 $ 1,529.6 Non-GAAP operating margin 48.8 % 46.5 % 48.3 % 46.9 % GAAP net income $ 888.8 $ 665.4 $ 1,702.6 $ 1,303.1 Stock-based compensation expense 85.2 79.3 178.2 156.5 Intangible asset amortization 5.0 6.7 10.6 13.4 (Gains)/losses on strategic investments (5.4 ) — (10.9 ) — Tax benefits on stock-based awards (41.6 ) (64.6 ) (107.7 ) (135.3 ) Income tax effect on non-GAAP exclusions (8.5 ) (14.2 ) (23.1 ) (27.3 ) Non-GAAP net income $ 923.5 $ 672.6 $ 1,749.7 $ 1,310.4 GAAP diluted net income per share (1) $ 0.70 $ 0.52 $ 1.34 $ 1.02 Non-GAAP adjustments to net income (1) 0.03 0.01 0.03 — Non-GAAP diluted net income per share (1) $ 0.73 $ 0.53 $ 1.37 $ 1.02 Weighted-average shares used in computing diluted net income per share (1) 1,271.2 1,279.7 1,275.2 1,279.6 Summary of Stock-Based Compensation Expense: Cost of revenue $ 5.8 $ 4.0 $ 11.3 $ 7.4 Research and development 53.2 50.7 110.2 94.5 Sales and marketing 18.8 16.8 38.7 35.7 General and administrative 7.4 7.8 18.0 18.9 Total $ 85.2 $ 79.3 $ 178.2 $ 156.5 (1) Prior period results have been adjusted to reflect the four-for-one stock split effected in December 2024. Expand ARISTA NETWORKS, INC. 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