SEC 8-K filings with transcript text
Nov 12, 2026
2 adrx-ex99_1.htm
Exhibit 99.1
ADARx Reports Third Quarter 2026 Financial Results and Provides Business Updates
– Completed initial public offering (IPO) and concurrent private placement generating aggregate gross proceeds of approximately $602.5 million; cash position expected to fund operations into 2030 –
– Advanced three Phase 2 clinical trials for agazisiran for the treatment of complement-mediated diseases –
– Received Fast Track designation for onvuzosiran for HAE –
SAN DIEGO, Calif., November 12, 2026 — ADARx Pharmaceuticals, Inc. (“ADARx” or the “Company”) (Nasdaq: ADRX), a late-clinical stage biotechnology company developing next-generation siRNA therapeutics, today reported financial results for the third quarter ended September 30, 2026, and provided a summary of recent business highlights.
“We have made significant progress across our pipeline of next-generation siRNA therapeutics, bolstered by the successful completion of our IPO and concurrent private placement. These financings provide the resources to advance three clinical-stage programs in parallel, bring two advanced preclinical candidates into the clinic, and support additional IND filings as we expand our pipeline,” said Zhen Li, Ph.D., President and Chief Executive Officer of ADARx. “As the siRNA field evolves, we see tremendous opportunity to expand the range of diseases these therapeutics can address. We believe that our progress with differentiated liver-targeted programs and targeted delivery to extrahepatic tissues positions us to advance our mission of delivering life-changing treatments to patients with unmet medical needs.”
Third Quarter 2026 and Recent Business Highlights
• Agazisiran – Advancing three Phase 2 clinical trials for the treatment of complement-mediated diseases: ADARx continued to advance three Phase 2 clinical trials ongoing in: (1) renal diseases, including IgA nephropathy (IgAN), complement 3 glomerulopathy (C3G) and immune complex membranoproliferative glomerulonephritis (IC-MPGN); (2) paroxysmal nocturnal hemoglobinuria (PNH); and (3) geographic atrophy (GA) secondary to age-related macular degeneration (AMD), to support its potential as a pipeline-in-a-product opportunity. ADARx intends to explore additional dosing regimens in its Phase 2 IgAN and PNH clinical trials.
• Onvuzosiran – Received Fast Track designation for HAE: In August 2026, the U.S. Food and Drug Administration (FDA) granted Fast Track designation to onvuzosiran for prophylaxis to prevent attacks of hereditary angioedema (HAE). Onvuzosiran is currently being evaluated in the Phase 3 STOP-HAE clinical trial (NCT06960213).
• ADX-626 – Advanced clinical development and Phase 2 planning in secondary stroke prevention (SSP) and stroke prevention in atrial fibrillation (AFib): Phase 2 planning for ADARx’s Factor XI (FXI) program is underway for development in SSP and for exploratory studies in stroke prevention in patients with AFib. Determination has been made to not evaluate higher doses after the third dose cohort (400 mg) in the ongoing Phase 1 trial, and the Company intends to evaluate higher doses in its planned Phase 2 clinical trial.
• Closed IPO and concurrent private placement for aggregate gross proceeds of approximately $602.5 million: ADARx closed its IPO of 30,187,500 shares of its common stock, including 3,937,500 shares issued and sold on October 1, 2026 upon the underwriters’ exercise in full of their option to purchase additional shares, at a price of $17.00 per share. All of the shares of common stock were offered by ADARx and gross proceeds from the IPO, before deducting underwriting discounts and commissions and other offering expenses, were $513.2 million. Together with gross proceeds of $89.3 million from the 5,255,542 shares issued and sold in the concurrent private placement with AbbVie, aggregate gross proceeds from the IPO and concurrent private placement totaled approximately $602.5 million. ADARx’s common stock began trading on the Nasdaq Global Select Market under the ticker symbol “ADRX” on September 25, 2026.
• Expanded leadership team with board and executive appointments: Executive leader and current K2 Therapeutics CEO, Ying Huang, Ph.D., was appointed to the Board of Directors and veteran human resources leader Robert Ackles was appointed as Chief People Officer to help guide the Company’s strategic growth.
Anticipated Key Milestones:
• Agazisiran (CFB) Phase 2 data:
o IgAN - mid-2027 (9-month UPCR reduction data), 2H 2027 (1-year eGFR stabilization data)
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• Onvuzosiran (PKK): Phase 3 STOP-HAE topline data by year-end 2027
• ADX-626 (FXI): Phase 2a/b initiation in SSP in 2027
• ADX-077 (OBE1): Phase 1 initiation in obesity in 2027
• ADX-199 (APP): Phase 1 initiation by year-end 2027 or early 2028
Third Quarter 2026 Financial Results
As of September 30, 2026, ADARx had cash, cash equivalents and short-term investments of $901.0 milli
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