AnGes, Inc.

Business Details

The AnGes, Inc. group operates in-house developed products such as the HGF Gene Therapy Product (Beperminogene Perplasmid) and NF-κB Decoy Oligo DNA, alongside exclusive domestic distribution of the progeria treatment Zokinvy, genome editing platform research and development conducted by subsidiary EmendoBio, and contracted Expanded Newborn Screening Test (ACRL) services. Revenue is composed of product sales and fee income, reflecting a drug-discovery venture-type business structure in which R&D expenses lead revenue generation.

Recent Overview

Operating loss widened due to increased R&D expenses; ordinary loss improved on foreign exchange gains; cash balance declined sharply

Business revenue for the first quarter of FY2026 (ending December 2026) increased to ¥203 million (up 20.4% year on year). Meanwhile, R&D expenses expanded to ¥1,007 million (up 27.5% year on year), driven by increased outsourcing fees for the U.S. FDA application of the HGF Gene Therapy Product (commission fees paid +¥158 million) and increased manufacturing test costs (outsourcing expenses +¥70 million), resulting in an operating loss of ¥1,496 million (a deterioration of ¥241 million year on year). However, a foreign exchange gain of ¥385 million was recorded due to revaluation of the U.S. dollar-denominated loan to EmendoBio, resulting in an ordinary loss of ¥1,110 million (an improvement of ¥127 million year on year). Cash and deposits stood at ¥836 million, down ¥1,046 million from the end of the previous fiscal year, reflecting notably tightened cash flow. ¥414 million was raised through exercise of the 46th series stock acquisition rights and ¥647 million through issuance of the 2nd unsecured bonds, but this was outweighed by business expenditure. Preparation of application documents toward a Rolling Submission of the BLA within 2026 is ongoing.

Key Products

Growth Drivers

• Enhanced product value and expectations for future milestone and royalty income from the HGF Gene Therapy Product's FDA Breakthrough Therapy designation and planned BLA submission (Rolling Submission) within 2026
• Continued expansion of contracted Expanded Newborn Screening Test services at ACRL (Q1 FY2026 (ending December 2026) fee income of ¥125 million, up 9.7% year on year)
• Expanding sales of the progeria treatment Zokinvy (Q1 FY2026 (ending December 2026) product sales of ¥79 million, up 42.4% year on year)
• Progress in the domestic Phase II clinical trial of NF-κB Decoy Oligo DNA and reduced financial risk through cost-sharing and Phase III discussions with Shionogi & Co., Ltd.
• Out-licensing of EmendoBio's OMNI nucleases (expanded licensing scope agreement with Anocca AB, joint research with Stanford University)
• Expanded indications for the Tie2 Receptor Agonist (AV-001) (expanded joint development agreement with Vasomune Therapeutics covering all disease indications, commencement of an investigator-initiated trial for hemodialysis patients)
• Flexible fundraising through the 46th series stock acquisition rights allotted to Cantor Fitzgerald Europe and the 2nd unsecured bonds

Risks

• Material uncertainty regarding going concern assumptions exists (continuing operating losses and negative operating cash flow, with cash and deposits declining sharply to ¥836 million)
• Fundraising through exercise of the 46th series stock acquisition rights is dependent on stock price and other market conditions, leaving future fundraising methods, amounts, and timing undetermined
• Risk of delay in BLA application and approval for the HGF Gene Therapy Product (submission planned within 2026, with application documents currently being prepared)
• The FY2026 (ending December 2026) full-year operating loss forecast of ¥10,230 million represents approximately double the prior-year figure, with R&D expenses expected to remain elevated
• Uncertainty regarding the profitability outlook for EmendoBio following its business restructuring (goodwill has already been fully impaired)
• Concerns over continued research and development at MyBiotics (an equity-method-unapplied affiliate) due to the Israel-Palestine conflict
• Foreign exchange risk (revaluation of the U.S. dollar-denominated loan to EmendoBio has a significant impact on profit and loss; a foreign exchange gain of ¥385 million was recorded this quarter, but there is a risk of movement in the opposite direction)