WATERTOWN, Mass., Nov. 12, 2020 (GLOBE NEWSWIRE) -- Aileron Therapeutics (NASDAQ:ALRN) today reported business highlights and financial results for the third quarter ended September 30, 2020.
“We recently achieved the critical milestone of clinical proof of concept of ALRN-6924, demonstrating a protective effect against severe anemia, thrombocytopenia and neutropenia in our ongoing Phase 1b trial of patients with p53-mutated small cell lung cancer undergoing treatment with topotecan,” said Manuel Aivado, M.D., Ph.D., President and Chief Executive Officer of Aileron. “These positive findings help inform our future clinical development strategy, which involves advancing randomized, controlled studies of ALRN-6924 in large cancer indications, including, non-small cell lung cancer, gastrointestinal cancers such as colorectal cancer, and other cancers.”
Dr. Aivado continued, “We are laying the foundation to advance our broad vision to bring chemoprotection to patients with p53-mutated cancers, which represent approximately 50% of cancer patients, regardless of cancer type or chemotherapy. We believe our approach, grounded on the principle of chemoprotection without the potential to interfere with chemotherapy’s anticancer activity, may establish ALRN-6924 as standard of care for chemoprotection among patients with p53-mutated cancers who are undergoing chemotherapy.”
Key Third Quarter and Recent Highlights
“Chemotherapy-induced toxicities are a long-overlooked and unaddressed area of significant unmet need among the millions of cancer patients undergoing chemotherapy,” said Dr. Aivado. “For our ongoing Phase 1b trial we have focused on chemotherapy-induced bone marrow toxicities because of their severe, often life-threatening consequences for patients and also because they are the most objectively quantifiable to evaluate chemoprotection. Biologically, we believe that ALRN-6924’s ability to arrest cell cycling in normal, healthy cells has the potential to protect patients undergoing chemotherapy against a spectrum of side effects beyond bone marrow toxicities, such as hair loss, nausea, vomiting, diarrhea and fatigue.”
Upcoming Milestones
Following the achievement of clinical proof-of-concept for ALRN-6924, Aileron anticipates undertaking the following next steps to progress and expand clinical development of ALRN-6924.
Third Quarter 2020 Financial Results
About Aileron Therapeutics
At Aileron, we are focused on transforming the experience of chemotherapy for cancer patients, enabling them to fight cancer without the fear or burden of chemotherapy-induced side effects. ALRN-6924, our first-in-class MDM2/MDMX dual inhibitor activating p53, is the only reported therapeutic agent in clinical development to employ a biomarker strategy, in which we exclusively focus on treating patients with p53-mutated cancers. With this unique, targeted strategy, ALRN-6924 is designed to protect multiple healthy cell types 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 better tolerate chemotherapy, potentially allowing patients to complete their treatment without dose reductions or delays. Our long-term vision is to bring chemoprotection to patients with p53-mutated cancers – approximately 50% of cancer patients – regardless of cancer type or chemotherapy. Visit us at aileronrx.com to learn more.
Forward-Looking Statements
Statements in this press release about Aileron's future expectations, plans and prospects, as well as any other statements regarding matters that 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 strategy and clinical development plans. The words “anticipate,” “believe,” “continue,” “could,” “estimate,” “expect,” “intend,” “may,” “plan,” “potential,” “predict,” “project,” “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 such forward-looking statements as a result of various important factors, including whether Aileron’s cash resources will be sufficient to fund its continuing operations for the periods anticipated; whether the Company will obtain sufficient cash resources to conduct its planned clinical trials; whether results obtained in clinical trials will be indicative of results obtained in future clinical trials; whether Aileron’s product candidates will advance through the clinical trial process on a timely basis, or at all; whether the results of such trials will be accepted by and warrant submission for approval from the United States Food and Drug Administration or equivalent foreign regulatory agencies; whether Aileron's product candidates will receive approval from regulatory agencies on a timely basis or at all; whether, if product candidates obtain approval, they will be successfully distributed and marketed; what impact the coronavirus pandemic may have on the timing of our clinical development, clinical supply and our operations; and other factors discussed in the "Risk Factors" section of Aileron's quarterly report on Form 10-Q for the period ended September 30, 2020, filed on November 12, 2020, and risks described in other filings that Aileron may make with the Securities and Exchange Commission. Any 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 statement, whether because of new information, future events or otherwise.
Investor Contacts: | Media Contact: |
Richard Wanstall, SVP Chief Financial Officer | Liz Melone |
Aileron Therapeutics | 617-256-6622 |
617-995-0900 | lmelone@aileronrx.com |
rwanstall@aileronrx.com | |
Hans C. Vitzthum | |
LifeSci Advisors, LLC. | |
617-430-7578 | |
hans@lifesciadvisors.com |
Aileron Therapeutics, Inc. | |||||||
Balance Sheet Data | |||||||
(In thousands) | |||||||
September 30, 2020 | December 31, 2019 | ||||||
Cash, cash equivalents and investments | $ | 14,121 | $ | 18,278 | |||
Working capital | $ | 10,725 | $ | 13,711 | |||
Total assets | $ | 22,239 | $ | 26,473 | |||
Accumulated deficit | $ | (214,296 | ) | $ | (198,135 | ) | |
Total stockholders' equity | $ | 12,458 | $ | 16,048 |
Aileron Therapeutics, Inc. | |||||||||||||||
Condensed Statement of Operations | |||||||||||||||
(In thousands, except share and per share data) | |||||||||||||||
Three Months Ended September 30, | Nine Months Ended September 30, | ||||||||||||||
2020 | 2019 | 2020 | 2019 | ||||||||||||
Revenue | $ | - | $ | - | $ | - | $ | - | |||||||
Operating expenses: | |||||||||||||||
Research and development | 2,684 | 4,475 | 9,241 | 12,953 | |||||||||||
General and administrative | 2,344 | 3,440 | 7,063 | 9,654 | |||||||||||
Total Operating expenses | 5,028 | 7,915 | 16,304 | 22,607 | |||||||||||
Loss from operations | (5,028 | ) | (7,915 | ) | (16,304 | ) | (22,607 | ) | |||||||
Gain on sale of property and equipment | - | - | 66 | - | |||||||||||
Interest income | 5 | 166 | 77 | 473 | |||||||||||
Net loss | (5,023 | ) | (7,749 | ) | (16,161 | ) | (22,134 | ) | |||||||
Net loss per share — basic and diluted | $ | (0.13 | ) | $ | (0.28 | ) | $ | (0.49 | ) | $ | (0.95 | ) | |||
Weighted average common shares outstanding—basic and diluted | 39,321,177 | 27,810,358 | 32,808,082 | 23,431,823 |