Business
Clene Reports Third Quarter 2022 Financial Results and Recent Operating Highlights
Secondary survival endpoint for the CNM-Au8® 30 mg dose investigated in the Healey ALS Platform Trial demonstrated a >90% reduction in the risk of death or
About this update from Clene Inc.
[{"type":"text","content":"Secondary survival endpoint for the CNM-Au8® 30 mg dose investigated in the Healey ALS Platform Trial demonstrated a >90% reduction in the risk of death or death equivalent (permanently assisted ventilation) and risk of death alone at 24 weeks. This survival benefit was consistent with prior results reported from the Phase 2 RESCUE-ALS trial long term open-label extension. Topline results from the Phase 2 VISIONARY-MS clinical trial of CNM-Au8® met the primary and secondary endpoints of Low Contrast Letter Acuity (LCLA) and global neurological improvement measured by the modified Multiple Sclerosis Functional Composite (mMSFC) compared to placebo over 48 weeks in the modified intent to treat (mITT) population. Cash, cash equivalents, and marketable securities of $16.2 million as of September 30, 2022. Closed a registered direct offering of $10.8 million with certain existing stockholders, including existing stockholders affiliated with Clene’s board of directors, for the purchase and sale of 10,723,926 shares of the Company’s common stock at a purchase price per share of $1.01, priced at-the-market based on the October 28, 2022, closing stock price, in a registered direct offering. Executed a Commitment Letter with the Maryland Department of Housing and Community Development to borrow $5.0 million. SALT LAKE CITY, Nov. 07, 2022 (GLOBE NEWSWIRE) -- Clene Inc. (Nasdaq: CLNN) (along with its subsidiaries, “Clene”) and its wholly owned subsidiary Clene Nanomedicine Inc., a clinical-stage biopharmaceutical company focused on revolutionizing the treatment of neurodegenerative disease, today reported its third quarter 2022 financial results and recent operating highlights. “Clene was pleased to report the significant survival benefit in people living with ALS in the Healey ALS Platform Trial at six months with the CNM-Au8® 30 mg dose. To our knowledge, this is the only study to show a survival benefit at 6-months in ALS,” said Rob Etherington, President and CEO of Clene. “Subsequent to the Healey data read-out, we have been able to secure sufficient capital to further strengthen our balance sheet, extend our financial runway, and support the regulatory path to potential marketing authorization. We remain in active discussions with potential strategic partners regarding CNM-Au8. We are also looking forward to the further results from th...