BOSTON, Nov. 12, 2021 (GLOBE NEWSWIRE) -- Aileron Therapeutics (NASDAQ:ALRN), a chemoprotection oncology company focused on fundamentally transforming the experience of chemotherapy for cancer patients, today reported financial results and business highlights for the third quarter ended September 30, 2021.

“In the third quarter, we continued our clinical progress, reporting final positive results from our chemoprotection proof-of-concept SCLC study and confirming ALRN-6924’s p21-mediated cell cycle arrest in our healthy volunteer study. We also reported healthy volunteer data on time to onset, magnitude and duration of ALRN-6924’s cell cycle arrest, which provides support for a universal dose and schedule across distinct chemotherapy regimens,” said Manuel Aivado, M.D., Ph.D., President and Chief Executive Officer at Aileron. “In the year ahead, we anticipate key data readouts from our NSCLC trial, as we continue to advance toward our vision to deliver selective chemoprotection to patients with p53-mutant cancers regardless of type of chemotherapy or cancer.”

Dr. Aivado continued, “We recently presented preclinical data demonstrating cell cycle arrest in healthy tissue outside of the bone marrow – namely, epithelial mucosa cells in the GI tract. This is another important strategic building block, as a key characteristic of ALRN-6924’s differentiated profile is the potential to selectively protect multiple tissues and organs from chemotherapy-induced toxicities with a single medicine – representing a potential paradigm shift in the care of millions of cancer patients.”

Despite the rise of immunotherapies and targeted therapies, chemotherapy continues to play a central role, at some point in the treatment continuum, for nearly all cancer patients, bringing with it significant toxicities. Aileron is developing ALRN-6924 to selectively protect healthy cells in patients with p53-mutated cancers to reduce or eliminate chemotherapy-induced side effects. Nearly 1 million patients each year are diagnosed with a p53-mutated cancer in the US alone. Aileron employs a precision medicine approach, exclusively treating patients with p53-mutated cancers; ALRN-6924 is designed to selectively protect these patients’ healthy cells from chemotherapy without protecting cancer cells. This novel concept is known as selective chemoprotection. The reduction or elimination of multiple chemotherapy-induced side effects may enhance tolerability of chemotherapy, may result in fewer dose reductions or delays of chemotherapy, and the potential for improved efficacy of chemotherapy. Aileron’s vision is to bring chemoprotection to patients with p53-mutated cancers, which represent approximately 50% of cancer patients, regardless of type of cancer or chemotherapy.

Third Quarter 2021 Highlights and Recent Updates

Third Quarter 2021 Financial Results

About Aileron Therapeutics

Aileron is a clinical stage chemoprotection oncology company focused on fundamentally transforming the experience of chemotherapy for cancer patients. 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 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 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-Q for the quarter ended September 30, 2021, filed on November 12, 2021, 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 OfficerLiz Melone
Aileron Therapeutics617-256-6622
617-995-0900lmelone@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, 2021 December 31, 2020 
      
Cash, cash equivalents and investments $52,232  $13,805  
Working capital  49,863   12,366  
Total assets  54,768   16,341  
Accumulated deficit  (238,657)  (219,292) 
Total stockholders' equity  50,109   12,162  


 
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,
  2021   2020   2021   2020 
        
Revenue$-  $-  $-  $- 
Operating expenses:       
Research and development 4,278   2,684   12,447   9,241 
General and administrative 2,513   2,344   7,342   7,063 
Total operating expenses 6,791   5,028   19,789   16,304 
Loss from operations (6,791)  (5,028)  (19,789)  (16,304)
Interest and other income, net 87   5   424   143 
Net loss (6,704)  (5,023)  (19,365)  (16,161)
Net loss per share — basic and diluted$(0.07) $(0.13) $(0.22) $(0.49)
Weighted average common shares outstanding — basic and diluted 90,548,972   39,321,177   88,211,362   32,808,082