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BOSTON, Nov. 01, 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 third quarter ended September 30, 2022.
“Several sites in the U.S. and Eastern Europe are now open for enrollment under the amended protocol for our breast cancer trial, and we expect multiple additional sites to open in Western and Eastern Europe in the fourth quarter of 2022 and the first quarter of 2023,” said Manuel Aivado, M.D., Ph.D., President and Chief Executive Officer at Aileron. “We’re grateful to have enthusiastic investigators who recognize the significant challenges that chemotherapy-induced toxicities present for cancer patients, the drawbacks that are associated with the limited supportive care treatments that are available, and the transformative potential of a single agent like ALRN-6924 that may simultaneously prevent multiple hematologic and non-hematologic toxicities.”
Third Quarter 2022 and Recent Highlights
Third 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, the Company’s planned enrollment and data readouts from its Phase 1b breast cancer trial, 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 the company will enroll patients in, and report data from, its Phase 1b breast cancer trial on a timely basis; 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 September 30, 2022, filed on November 1, 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: Stern Investor Relations Alexander Lobo alex.lobo@sternir.com | Media Contact: Liz Melone lmelone@aileronrx.com |
| Aileron Therapeutics, Inc. | ||||||||
| Selected Balance Sheet Data | ||||||||
| (In thousands) | ||||||||
| September 30, 2022 (Unaudited) | December 31, 2021 (Audited) | |||||||
| Cash, cash equivalents and investments | $ | 25,477 | $ | 45,933 | ||||
| Working capital | 22,518 | 43,669 | ||||||
| Total assets | 27,232 | 48,481 | ||||||
| Accumulated deficit | (268,238 | ) | (245,456 | ) | ||||
| Total stockholders' equity | 22,696 | 43,904 | ||||||
| Aileron Therapeutics, Inc. | ||||||||||||||||
| Condensed Statement of Operations (Unaudited) | ||||||||||||||||
| (In thousands, except share and per share data) | ||||||||||||||||
| Three Months Ended September 30, | Nine Months Ended September 30, | |||||||||||||||
| 2022 | 2021 | 2022 | 2021 | |||||||||||||
| Revenue | $ | - | $ | - | $ | - | $ | - | ||||||||
| Operating expenses: | ||||||||||||||||
| Research and development | 4,239 | 4,278 | 15,565 | 12,447 | ||||||||||||
| General and administrative | 2,243 | 2,513 | 7,379 | 7,342 | ||||||||||||
| Total Operating expenses | 6,482 | 6,791 | 22,944 | 19,789 | ||||||||||||
| Loss from operations | (6,482 | ) | (6,791 | ) | (22,944 | ) | (19,789 | ) | ||||||||
| Interest and other income, net | 114 | 87 | 162 | 424 | ||||||||||||
| Net loss | (6,368 | ) | (6,704 | ) | (22,782 | ) | (19,365 | ) | ||||||||
| Net loss per share — basic and diluted | $ | (0.07 | ) | $ | (0.07 | ) | $ | (0.25 | ) | $ | (0.22 | ) | ||||
| Weighted average common shares outstanding—basic and diluted | 90,823,597 | 90,548,972 | 90,744,146 | 88,211,362 | ||||||||||||