BOSTON, Aug. 15, 2022 (GLOBE NEWSWIRE) -- 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.
“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
Second Quarter 2022 Financial Results
About Aileron Therapeutics
Aileron is a clinical stage chemoprotection oncology company that aspires to make chemotherapy safer and thereby more effective to save more patients’ lives. ALRN-6924, our first-in-class MDM2/MDMX dual inhibitor, is designed to activate p53, which in turn upregulates p21, a known inhibitor of the cell replication cycle. ALRN-6924 is the only reported chemoprotective agent in clinical development to employ a biomarker strategy, in which we exclusively focus on treating patients with p53-mutated cancers. Our targeted strategy is designed to selectively protect multiple healthy cell types throughout the body from chemotherapy without protecting cancer cells. As a result, healthy cells are spared from chemotherapeutic destruction while chemotherapy continues to kill cancer cells. By reducing or eliminating multiple chemotherapy-induced side effects, ALRN-6924 may improve patients’ quality of life and help them better tolerate chemotherapy. Enhanced tolerability may result in fewer dose reductions or delays of chemotherapy and the potential for improved efficacy.
Our vision is to bring chemoprotection to all patients with p53-mutated cancers, which represent approximately 50% of cancer patients, regardless of type of cancer 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 potential of ALRN-6924 as a chemoprotective agent, the Company’s strategy and clinical development plans and the Company’s cash runway. 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 or with respect to the matters anticipated; whether initial results of clinical trials will be indicative of final results of those trials or results obtained in future clinical trials, including trials in different indications; whether ALRN-6924 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 ALRN-6924 will receive approval from regulatory agencies on a timely basis or at all or in which territories or indications ALRN-6924 may receive approval; whether, if ALRN-6924 obtains approval, it 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 annual report on Form 10-K for the year ended December 31, 2021, filed on March 28, 2022, and quarterly report on Form 10-Q for the quarter ended June 30, 2022, filed on August 15, 2022, 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 Contact: | Media Contact: |
Stern Investor Relations | Liz Melone |
Alexander Lobo | [email protected] |
[email protected] |
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1 U.S. Food & Drug Administration (FDA) Statistical Review of FULPHILA®
2 Martin et al., N Engl J Med 2005;352:2302-13.
Aileron Therapeutics, Inc. | ||||||||
Balance Sheet Data | ||||||||
(In thousands) | ||||||||
June 30, 2022 | December 31, 2021 | |||||||
Cash, cash equivalents and investments | $ | 32,382 | $ | 45,933 | ||||
Working capital | 28,399 | 43,669 | ||||||
Total assets | 33,770 | 48,481 | ||||||
Accumulated deficit | (261,870 | ) | (245,456 | ) | ||||
Total stockholders' equity | 28,619 | 43,904 |
Aileron Therapeutics, Inc. | |||||||
Condensed Statement of Operations | |||||||
(In thousands, except share and per share data) | |||||||
Three Months Ended June 30, | |||||||
2022 | 2021 | ||||||
Revenue | $ | - | $ | - | |||
Operating expenses: | |||||||
Research and development | 5,433 | 3,853 | |||||
General and administrative | 2,608 | 2,156 | |||||
Total Operating expenses | 8,041 | 6,009 | |||||
Loss from operations | (8,041 | ) | (6,009 | ) | |||
Interest and other income, net | 49 | 323 | |||||
Net loss | (7,992 | ) | (5,686 | ) | |||
Net loss per share — basic and diluted | $ | (0.09 | ) | $ | (0.06 | ) | |
Weighted average common shares outstanding—basic and diluted | 90,823,597 | 90,458,550 | |||||