Allena Pharmaceuticals Inc (NASDAQ:ALNA) narrowed net loss by 61.4% to $7 million in Q2 2020. Its cash/ cash equivalents declined to $26.5 million in Q2 2020. The company also lowered R&D expenses to $3.8 million in Q2 2020.
CEO of Allena, Louis Brenner, said its team quickly implemented the planned activities across its portfolio comprising Phase 1 clinical trial of ALLN-346 and expanding the clinical trial sites for URIROX-2. The business partners and trial investigators played an important role in enrolling the patients for the second Phase 3 clinical trial. It is the final clinical study for URIROX-2 to obtain necessary data for IND submission and get the nod for the treatment of patients suffering from enteric hyperoxaluria.
Commences trial of ALLN-346
Allena also commenced clinical trial of oral enzyme therapeutic ALLN-346 in humans. The new drug will be used to cure renally impaired people with gout and hyperuricemia. Available treatment options for such patients are inadequate because of safety concerns. Allena expects to obtain initial data of ALLN-346 by the end of 2020. The company expects to complete the first interim analysis of URIROX-2 in Q1 2022.
Allena is investigating a non-absorbed, first in class, orally administered enzyme – reloxaliase to treat patients suffering from EH (enteric hyperoxaluria). It is the second Phase 3 clinical study in the URROX program. The company is expanding the URIROX-2 clinical study to new geographies and sites. It expects to get an interim analysis of this clinical study in Q1 2022. The company will report its topline data for BLA submission in Q3 2022.
Allena is continuing discussions with the US FDA for exploring expedited registration paths for its reloxaliase in people suffering from CKD (chronic kidney disease) and EH.
Increases size of the public offering
Allena enhanced the size of the bought deal offering to 5.125 million common shares on increased demand. The company expects to close the deal on or before July 30, 2020. It has appointed H.C. Wainwright & Co as a book-running manager for this deal. The underwriters have an option to acquire 768,807 additional shares within 30 days. Allena will net $6.7 million from this bought deal offering before deducting commissions and discounts to the underwriters.