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Aileron Therapeutics, Inc. (NASDAQ: ALRN) is a clinical-stage biopharmaceutical company pioneering the development of first-in-class medicines to address significant unmet medical needs in orphan pulmonary and fibrosis indications. Located in Boston, Massachusetts, Aileron is leading the front in peptide therapeutics, focusing on innovative treatments for severe diseases.
The company’s flagship product is ALRN-6924, a unique chemoprotective agent designed to reactivate p53-mediated tumor suppression. Currently under multiple clinical trials, ALRN-6924 targets both MDMX and MDM2 proteins, pivotal in restoring the p53 function, often referred to as the “guardian of the genome,” due to its significant role in cancer prevention.
Another promising candidate is LTI-03, a novel Caveolin-1-related peptide in development for treating idiopathic pulmonary fibrosis (IPF). It is in a Phase 1b clinical trial, with results expected in the second quarter of 2024. Additionally, LTI-01 is a proenzyme under clinical evaluation for treating loculated pleural effusions, having completed Phase 1b and Phase 2a trials.
In the wake of challenging results from a Phase 1b breast cancer trial of ALRN-6924, leading to its termination, Aileron has been exploring strategic alternatives to maximize shareholder value. Recently, the company acquired Lung Therapeutics, Inc., integrating a pipeline of therapies targeting orphan pulmonary diseases.
The company remains well-funded, following an $18 million acquisition-financing round, bolstering its financial stability to propel ongoing clinical trials and corporate initiatives. As Aileron transitions under new leadership, with Dr. Brian Windsor as CEO, it continues to prioritize advancing its therapeutic candidates toward commercialization.
Visit aileronrx.com for more information about their groundbreaking research and future developments.
Aileron Therapeutics (Nasdaq: ALRN) announced on November 30, 2022, that it has regained compliance with Nasdaq's minimum bid price requirement. The Nasdaq Stock Market confirmed that Aileron’s closing bid price exceeded $1.00 per share for 10 consecutive business days, ending November 25, 2022. This compliance allows the company to maintain its listing. Aileron focuses on developing ALRN-6924, a chemoprotective agent targeting p53-mutated cancers, aiming to enhance chemotherapy efficacy while reducing side effects.
Aileron Therapeutics (Nasdaq: ALRN) announced a 1-for-20 reverse stock split of its common stock effective at 5:00 p.m. ET on November 10, 2022. The split aims to comply with Nasdaq’s minimum bid price requirement, reducing the number of outstanding shares from approximately 90.8 million to 4.5 million. Trading on a split-adjusted basis will begin on November 11, 2022. No fractional shares will be issued; instead, stockholders will receive cash payments for any fractional shares. This transition affects all stockholders uniformly without altering their percentage interests.
Aileron Therapeutics (ALRN) has activated multiple sites for its Phase 1b breast cancer trial, with additional site activations expected in Q4 2022 and Q1 2023. Recent presentations highlighted the potential of ALRN-6924 to prevent chemotherapy-induced toxicities, including neutropenia and alopecia. Cash reserves stood at $25.5 million, expected to fund operations through Q1 2024. R&D expenses were stable at $4.2 million, while G&A expenses decreased to $2.2 million. The net loss for Q3 2022 was $6.4 million, consistent with the previous year.
Aileron Therapeutics (Nasdaq: ALRN) presented results from its Phase 1 study of ALRN-6924 at the EORTC-NCI-AACR conference. The study demonstrated ALRN-6924's potential to prevent chemotherapy-induced side effects, including neutropenia, thrombocytopenia, and alopecia, by inducing p53-mediated cell cycle arrest in bone marrow stem cells and hair follicles. Aileron selected a 1.2 mg/kg dose for its ongoing Phase 1b trial in p53-mutated breast cancer patients. Safety profiles were consistent across administration methods, suggesting a simplified bolus option for future use.
Aileron Therapeutics (Nasdaq: ALRN) announced new ex vivo data demonstrating that ALRN-6924 protects hair follicles from damage caused by chemotherapy agents cyclophosphamide and taxanes. During a presentation at the European Society for Dermatological Research, findings highlighted ALRN-6924's ability to temporarily arrest the cell cycle in scalp hair follicles and stem cells, potentially preventing alopecia. This agent is currently evaluated in an ongoing Phase 1b trial focused on breast cancer patients, aiming to reduce chemotherapy-induced side effects. Anticipated trial results are expected in late 2022 and throughout 2023.
Aileron Therapeutics (Nasdaq: ALRN) announced that Dr. Manuel Aivado, President and CEO, will present at the Ladenburg Thalmann 2022 Healthcare Conference on September 29, 2022, at 3:30 p.m. ET in New York. A webcast of the presentation will be available on their website and archived for 30 days. Aileron, a clinical-stage oncology company, focuses on making chemotherapy safer with their drug ALRN-6924, designed to protect healthy cells during treatment while targeting cancer cells. This innovation aims to improve the quality of life for patients with p53-mutated cancers.
Aileron Therapeutics (Nasdaq: ALRN) has announced a pre-recorded corporate presentation scheduled for September 12, 2022, at 7:00 a.m. ET, during the H.C. Wainwright 24th Annual Global Investment Conference. The presentation will focus on the company's chemoprotection oncology efforts to enhance chemotherapy safety and effectiveness. It will be accessible on-demand through the company's website and archived for 30 days. Aileron's lead product, ALRN-6924, targets p53-mutated cancers, aiming to improve patients' quality of life and treatment tolerability.
Aileron Therapeutics (Nasdaq: ALRN) has reported advancements on ALRN-6924, focusing on its clinical trial for breast cancer patients with p53 mutations. The company has extended its cash runway to support operations through Q1 2024. Recent data suggests ALRN-6924 could protect against chemotherapy-induced alopecia and prevent damage to hair follicle stem cells. The company also appointed Susan L. Drexler as interim CFO and strengthened its intellectual property portfolio with a new patent in China. For Q2 2022, Aileron reported an $8 million net loss, with cash standing at $32.4 million.
Aileron Therapeutics (Nasdaq: ALRN) announced enhancements to its Phase 1b trial of ALRN-6924 for p53-mutated breast cancer, aiming to improve chemoprotection against chemotherapy-induced severe neutropenia and alopecia. Key updates include increasing the dose to 1.2 mg/kg and modifying the primary endpoint to focus on severe neutropenia in cycle 1. The trial’s cash runway is extended through Q1 2024, enabling topline results to potentially support a pivotal trial. Readouts are expected in 4Q 2022, 2Q 2023, and 3Q 2023.
Aileron Therapeutics (Nasdaq: ALRN) announced that CEO Manuel Aivado will participate in a fireside chat at the William Blair Biotech Focus Conference 2022. The chat will be available on-demand starting July 11, 2022. Management will also meet in-person at the conference on July 12, 2022. Aileron focuses on chemoprotection oncology, aiming to make chemotherapy safer and more effective. Their lead product, ALRN-6924, is designed to protect healthy cells from chemotherapy while targeting cancer cells, particularly in patients with p53-mutated cancers, which encompass about 50% of cancer patients.
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