On November 1, 2022 Aileron Therapeutics (Nasdaq: ALRN), a chemoprotection oncology company that aspires to make chemotherapy safer and thereby more effective to save more patients’ lives today, reported financial results and business highlights for the third quarter ended September 30, 2022 (Press release, Aileron Therapeutics, NOV 1, 2022, View Source [SID1234622724]).
Schedule your 30 min Free 1stOncology Demo!
Discover why more than 1,500 members use 1stOncology™ to excel in:
Early/Late Stage Pipeline Development - Target Scouting - Clinical Biomarkers - Indication Selection & Expansion - BD&L Contacts - Conference Reports - Combinatorial Drug Settings - Companion Diagnostics - Drug Repositioning - First-in-class Analysis - Competitive Analysis - Deals & Licensing
Schedule Your 30 min Free Demo!
"Several sites in the U.S. and Eastern Europe are now open for enrollment under the amended protocol for our breast cancer trial, and we expect multiple additional sites to open in Western and Eastern Europe in the fourth quarter of 2022 and the first quarter of 2023," said Manuel Aivado, M.D., Ph.D., President and Chief Executive Officer at Aileron. "We’re grateful to have enthusiastic investigators who recognize the significant challenges that chemotherapy-induced toxicities present for cancer patients, the drawbacks that are associated with the limited supportive care treatments that are available, and the transformative potential of a single agent like ALRN-6924 that may simultaneously prevent multiple hematologic and non-hematologic toxicities."
Third Quarter 2022 and Recent Highlights
Activated multiple existing and new trial sites in the U.S. and Europe under amended Phase 1b breast cancer trial protocol, with planned activation of additional sites in 4Q 2022 and 1Q 2023. This open-label, single-arm, multicenter trial is designed to evaluate the chemoprotective effect of 1.2 mg/kg dose of ALRN-6924 against severe neutropenia, as well as chemotherapy-induced alopecia, and other hematologic and non-hematologic toxicities, in breast cancer patients with p53-mutant tumors who are undergoing either neoadjuvant or adjuvant treatment with docetaxel, doxorubicin and cyclophosphamide, also known as TAC. Aileron plans to report initial data from the breast cancer trial in 4Q 2022, an interim readout in 2Q 2023, and topline results in 3Q 2023.
Presented detailed results from Phase 1 study in healthy volunteers at the EORTC-NCI-AACR (Free EORTC-NCI-AACR Whitepaper) AACR-NCI-EORTC (Free AACR-NCI-EORTC Whitepaper) International Conference on Molecular Targets and Cancer Therapeutics (EORTC-NCI-AACR) (Free ASGCT Whitepaper) (Free EORTC-NCI-AACR Whitepaper). The poster presentation in October 2022 included results demonstrating the potential of ALRN-6924 to prevent chemotherapy-induced neutropenia, thrombocytopenia, and anemia, as well as chemotherapy-induced alopecia in patients with p53-mutated cancer. The presentation also included data showing that higher doses of ALRN-6924 prolonged the elevation of serum macrophage inhibitory cytokine-1 (MIC-1), a biomarker of p53 activation, in a dose-dependent fashion. Based on these findings, Aileron believes that the degree and duration of serum MIC-1 elevation at higher ALRN-6924 dose levels indicates more durable cell cycle arrest in bone marrow and other tissues, and thereby prolonged chemoprotection. These healthy volunteer study results, combined with clinical results from a 1.2 mg/kg cohort of topotecan-treated patients in Aileron’s previously conducted proof-of-concept study of ALRN-6924 in p53-mutated small cell lung cancer, support the company’s selection of a 1.2 mg/kg dose in its breast cancer trial. The EORTC-NCI-AACR (Free EORTC-NCI-AACR Whitepaper) presentation also included data showing that safety profiles, pharmacokinetics and pharmacodynamics were similar for both a 3-minute intravenous (IV) bolus and a 1-hour IV infusion of ALRN-6924, providing rationale for future development of ALRN-6924 bolus IV administration.
Presented new non-clinical data demonstrating ALRN-6924 protected human hair follicles and their stem cells from cyclophosphamide-induced toxicity and irreversible stem cell damage. The ex vivo data – developed in collaboration with Professor Ralf Paus, M.D., DSc, FRSB and his colleagues at the Dr. Phillip Frost Department of Dermatology & Cutaneous Surgery at the University of Miami Miller School of Medicine – were highlighted in an oral presentation at the European Society for Dermatological Research (ESDR) Annual Meeting in September 2022. The ESDR presentation also included ex vivo data previously reported by Dr. Paus and his colleagues showing proof of principle that ALRN-6924 can temporarily arrest the cell cycle in human scalp hair follicles and their stem cells as well as protect hair follicles from paclitaxel-induced toxicity and irreversible stem cell damage.
Third Quarter 2022 Financial Results
Cash Position: Cash, cash equivalents, and investments on September 30, 2022, were $25.5 million, compared to $45.9 million on December 31, 2021. Based on its current operating plan, the company expects its existing cash, cash equivalents, and investments will fund operations through the end of first quarter of 2024.
Research and Development (R&D) Expenses: R&D expenses for the quarter ended September 30, 2022, were $4.2 million, compared to $4.3 million for the quarter ended September 30, 2021. R&D expenses decreased by less than $0.1 million for the three months ended September 30, 2022, which was primarily due to a decrease in manufacturing costs for ALRN-6924, offset by an increase in spending for the company’s Phase 1b breast cancer trial, during the third quarter of 2022 as compared to the same period in 2021.
General and Administrative (G&A) Expenses: G&A expenses for the quarter ended September 30, 2022, were $2.2 million compared to $2.5 million for the quarter ended September 30, 2021. G&A expenses decreased by $0.3 million for the three months ended September 30, 2022, which was primarily due to a decrease in stock compensation expense during the third quarter of 2022 as compared to the same period in 2021.
Net Loss: Net loss for the quarter ended September 30, 2022, was $6.4 million, compared to $6.7 million for the corresponding quarter in 2021. The basic and diluted net loss per share for the third quarter of 2022 was $0.07 compared to $0.07 for the third quarter of 2021.