Aileron Therapeutics Announces Completion of $ 35.9 Million Registered Direct Offer with New Fundamental Health Investors Acorn Bioventures, BVF Partners, LP and Maven Investment Partners
– Several existing Aileron investors, including Satter Medical Technology Partners and Lincoln Park Capital Fund, LLC, also participated in the offering –
– Aileron plans to use the net proceeds to undertake a phase 1b chemoprotection trial of ALRN-6924 in patients with advanced non-small cell lung cancer mutated by p53 (NSCLC) –
– Company Plans to Launch Randomized, Placebo-Controlled Phase 1b NSCLC Trial in Q2 2021, Marking Expansion of Clinical Development of ALRN-6924 in Large Cancer Indication –
WATERTOWN, Mass., Jan. 11, 2021 (GLOBE NEWSWIRE) – Aileron Therapeutics, Inc. (Nasdaq: ALRN) today announced the completion of its previously announced registered direct offering of 32,630,983 of its common shares at a price of purchase of $ 1.10 per share, for gross proceeds of $ 35.9 million, before deducting sales agent fees and other offering fees payable by Aileron. Aileron is developing ALRN-6924 as a new drug to selectively protect healthy cells in cancer patients with p53 mutations to reduce or eliminate chemotherapy-induced side effects while preserving the effects of chemotherapy against them. cancer cells, a concept known as chemoprotection.
New core investors, including Acorn Bioventures, BVF Partners, LP, Maven Investment Partners and Grand Oaks Capital, participated in the offering, in addition to several existing Aileron investors, including Satter Medical Technology Partners and Lincoln Park Capital Fund, LLC.
JonesTrading Institutional Services LLC (“JonesTrading”) acted as placement agent for the Offer.
In addition to the registered direct offering of $ 35.9 million, between November 12, 2020 and January 5, 2021, Aileron sold a total of 9,894,519 common shares in “to market” offers in the Capital on Demand frameworkTM Sales contract with JonesTrading resulting in total gross proceeds of approximately $ 12.7 million. The combined gross proceeds of the two offerings were $ 48.6 million before the deduction of commissions and fees.
With the proceeds of these transactions, Aileron estimates that its cash, cash equivalents and investments will allow it to fund its current strategic plan through the second half of 2023, including the planned clinical trial of ALRN-6924 in patients. with advanced non-small cell cancer. lung cancer (NSCLC).
“We are delighted to welcome Acorn Bioventures, BVF Partners and Maven Investment Partners as fundamental healthcare investors in Aileron. We believe that the participation of these funds, in addition to the continued support of existing major Aileron investors, is further validation of the potential of ALRN-6924 as an important drug in the emerging field of chemoprotection, ”said Manuel Aivado, MD, Ph. D., President and CEO of Aileron. “With the full offering, we are well positioned to continue moving forward towards our vision of providing chemoprotection to all patients with p53-mutant cancer, regardless of cancer type or chemotherapy. “
Dr Aivado continued, “For decades the medical community has largely resigned itself to the grim reality that chemotherapy destroys healthy cells while destroying cancer cells. 2021 promises to initiate a shift in this long-held mindset with the impending date of PDUFA and the potential approval of the industry’s first chemoprotective agent.1 which, similar to ALRN-6924, aims to protect healthy cells from the side effects of chemotherapy. Given the growing interest in chemoprotection and the large unmet medical need, we believe that ALRN-6924 has the potential to play an important and broad role in proactively preventing the harmful effects of chemotherapy on patients. cancer patients.
Aileron plans to begin enrollment in a randomized, double-blind, placebo-controlled clinical trial of ALRN-6924 in patients with advanced p53-mutated NSCLC receiving first-line carboplatin doublet chemotherapy treatment (with or without immune checkpoint inhibitors), in the second quarter of 2021. The planned phase 1b NSCLC trial follows the presentation by Aileron in October 2020 of clinical data from its ongoing phase 1b clinical trial of ALRN -6924 in small cell lung cancer (SCLC) demonstrating the clinical proof of concept that treatment with ALRN -6924 resulted in a protective effect against severe anemia, thrombocytopenia and neutropenia in patients with mutated SCLC p53 treated with topotecan. Aileron plans to release the first trial results at the end of the fourth quarter of 2021 and the full results in mid-2022.
This press release does not constitute an offer to sell or the solicitation of an offer to buy such securities, and there will be no sale of such securities in any State or other jurisdiction in which such an offer, solicitation or sale would be illegal prior to registration or qualification under the securities laws of any such state or other jurisdiction.
How ALRN-6924 is designed to protect healthy cells from chemotherapy
ALRN-6924 is being developed by Aileron as a novel chemoprotective drug to selectively protect healthy cells in cancer patients with p53 mutations in order to reduce or eliminate side effects induced by chemotherapy.
Chemotherapy acts preferentially on cells in cycle or in the process of cell division. In cancer cells, the cell cycle is not controlled, which leads to uncontrolled cell proliferation, a hallmark of cancer. Certain types of healthy cells also naturally need to cycle, such as bone marrow cells, hair follicle cells, skin cells, and cells lining the oral cavity and gastrointestinal tract. As a result, chemotherapy preferentially targets and kills both healthy cells in cycle and cancer cells in cycle. This, in turn, can lead to a range of chemotherapy-induced side effects, from unpleasant to fatal and potentially fatal.
ALRN-6924, a first-in-class experimental MDM2 / MDMX dual inhibitor, is given before chemotherapy to patients with p53 mutant cancers. ALRN-6924 is designed to activate normal p53 protein in healthy patients’ cells, temporarily and reversibly interrupting the cell cycle to selectively protect healthy cells in patients against chemotherapy. Protection is limited to healthy cells because ALRN-6924 cannot function in cancer cells mutated by p53 since the mutated p53 has lost its function in these cells. Therefore, cancer cells continue to cycle without interruption and remain entirely susceptible to destruction by chemotherapy.
1 The United States Food & Drug Administration has set the Prescription Drug User Fee Act (PDUFA) on February 15, 2021 for the investigational treatment of trilaciclib from G1 Therapeutics, Inc.
About Aileron Therapeutics
Aileron is a clinical-stage biopharmaceutical company focused on transforming the chemotherapy experience for cancer patients, enabling them to fight cancer without the fear or burden of chemotherapy-induced side effects. ALRN-6924, the first inhibitor of the MDM2 / MDMX class activating p53, is the only chemoprotective agent reported in clinical development to use a biomarker strategy, in which the company focuses exclusively on the treatment of patients with p53 mutated cancers. Using this unique targeted strategy, ALRN-6924 is designed to protect several types of healthy cells throughout the body from chemotherapy while chemotherapy continues to destroy cancer cells.
In addition to potentially reducing or eliminating multiple side effects, ALRN-6924 may also improve patients’ quality of life and help them tolerate chemotherapy better, potentially allowing patients to complete their treatment without dose reduction or delay. Our vision is to provide chemoprotection to patients with p53 mutated cancers – approximately 50% of cancer patients – regardless of the type of cancer or chemotherapy. Visit us at aileronrx.com to learn more.
The statements contained in this press release concerning Aileron’s expectations, future plans and prospects, as well as any other statements concerning matters which are not historical facts, may constitute forward-looking statements within the meaning of the Private Securities Litigation Reform. Act of 1995. These statements include, but are not limited to, statements about the Company’s clinical development strategy and plans. The words “anticipate”, “believe”, “continue”, “could”, “estimate”, “expect”, “intend to”, “may”, “,. “Should”, “target”, “would” and similar expressions are intended to identify forward-looking statements, although not all forward-looking statements contain these identifying words. Actual results may differ materially from those indicated by these forward-looking statements due to various important factors, including whether Aileron’s cash resources will be sufficient to fund its continuing operations for the anticipated periods; whether the Company will obtain sufficient cash resources to conduct its planned clinical trials; whether the initial results of clinical trials will be indicative of the final results of those trials or of the results obtained in future clinical trials; whether Aileron’s product candidates will progress through the clinical trial process in a timely manner, or not at all; whether the results of these tests will be accepted and submitted for approval to the United States Food and Drug Administration or equivalent foreign regulatory agencies; whether Aileron’s product candidates will receive regulatory approval in a timely manner or not at all; whether, if the product candidates are approved, they will be distributed and marketed successfully; what impact can the coronavirus pandemic have on the timeline of our clinical development, clinical supply and operations; and other factors discussed in the “Risk Factors” section of the Aileron Quarterly Report on Form 10-Q for the period ended September 30, 2020, filed November 12, 2020, and the risks described in other filings by Aileron with the Securities and Exchange Commission. All forward-looking statements contained in this press release speak only as of the date hereof, and Aileron specifically disclaims any obligation to update any forward-looking statements, whether as a result of new information, future events or otherwise. .