On August 15, 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 second quarter ended June 30, 2022 (Press release, Aileron Therapeutics, AUG 15, 2022, View Source [SID1234618353]).

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"As we announced earlier this month, we are pleased that we have extended our cash runway, which is now expected to fund our operations through the end of 1Q 2024. We expect that our cash resources will support key planned data readouts from our ongoing breast cancer trial, including initial data in 4Q 2022, an interim readout in 2Q 2023, and topline results in 3Q 2023, in addition to pivotal trial readiness activities, subject to the breast cancer trial data and discussions with the FDA," said Manuel Aivado, M.D., Ph.D., President and Chief Executive Officer at Aileron.

Dr. Aivado continued, "Supportive care continues to be a severely underserved medical need. Available pharmacologic therapies, like G-CSF for severe neutropenia and EPO for anemia, have limited efficacy and are associated with severe toxicities of their own. For several other toxicities, like alopecia, there are no approved pharmacologic therapies. Chemotherapy-induced toxicities frequently can lead to dose reductions and delays, significant adverse impact on quality of life, and premature treatment discontinuations. By delivering a chemoprotective agent that can effectively protect multiple tissue types simultaneously, we have the potential to usher in a new era in supportive care where ‘whole patient care’ becomes the accepted and expected standard."

Second Quarter 2022 and Recent Highlights

Preparing to re-initiate enrollment of Phase 1b breast cancer clinical trial. As recently announced, Aileron anticipates reinitiating enrollment in the breast cancer trial under the amended protocol in the coming weeks. The Phase 1b 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. Previous data has shown that up to 75% of patients receiving TAC experience severe neutropenia in cycle 1 despite prophylactic use of G-CSF1, and up to 98% of patients experience alopecia2.

Presented new non-clinical data demonstrating ALRN-6924 protected human hair follicles and their stem cells from paclitaxel-induced toxicity and irreversible stem cell damage. The new 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 a late-breaking oral presentation at the Society of Clinical Dermatology Annual Meeting. The data demonstrated 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.

Reported new pharmacodynamic (PD) effect and mechanism of action data from the recently completed Phase 1 pharmacology study of ALRN-6924 in healthy human volunteers. Previous PD data demonstrated that serum levels of MIC-1 were correlated with bone marrow p21, which is a marker for cell cycle arrest. The most recent PD data demonstrated that higher doses of ALRN-6924 prolonged the elevation of serum MIC-1 in a dose-dependent fashion. Based on these findings, Aileron believes that prolonged elevation of serum levels of MIC-1 at higher ALRN-6924 dose levels should indicate prolonged cell cycle arrest in bone marrow and other tissues, and thereby prolonged chemoprotection. Aileron has submitted these and other results from the healthy volunteer study for presentation at a scientific congress in 2H 2022.

Strengthened intellectual property (IP) portfolio with additional composition of matter patent for ALRN-6924 in China. The China National Intellectual Property Administration granted Aileron patent No. ZL 2020114599292, providing exclusivity over the composition of matter of ALRN-6924. Aileron’s strong IP portfolio comprises over 160 U.S. and foreign patents, including ALRN-6924 compositions of matter, drug product formulations, methods of manufacture, and methods of use. Aileron maintains exclusive worldwide rights to its proprietary peptide drug technology and ALRN-6924.

Appointed Susan L. Drexler, MBA, CPA, as Interim CFO. Ms. Drexler is an accomplished executive with over 25 years of experience with development- and commercial-stage life science companies in financial management, M&A and licensing deals, financial planning & analysis, and business analytics. Ms. Drexler was most recently CFO with Harmony Biosciences Holdings, Inc., where she oversaw finance, accounting, and IT operations.
Second Quarter 2022 Financial Results

Cash Position: Cash, cash equivalents, and investments on June 30, 2022, were $32.4 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 June 30, 2022, were $5.4 million, compared to $3.9 million for the quarter ended June 30, 2021. R&D expenses increased by $1.6 million which was primarily due to $1.0 million of spending for our Phase 1b clinical trial in breast cancer, $0.2 million of increased spending for our Phase 1b clinical trial in non-small cell lung cancer, and $0.3 million of increased manufacturing costs for ALRN-6924 to support our clinical trials and research studies.

General and Administrative (G&A) Expenses: G&A expenses for the quarter ended June 30, 2022, were $2.6 million compared to $2.2 million for the quarter ended June 30, 2021. G&A expenses increased by $0.5 million, which was primarily due to an increase in professional services fees during the second quarter of 2022 as compared to the same period in 2021.

Net Loss: Net loss for the quarter ended June 30, 2022, was $8.0 million, compared to $5.7 million for the corresponding quarter in 2021. The basic and diluted net loss per share for the second quarter of 2022 was $0.09 compared to $0.06 for the second quarter of 2021.