ALRN Aileron Therapeutics Inc.

1.01
+0.01  (+1%)
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Market Cap $91,231,126
Shares 90,327,848
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Enterprise Value $30,287,683
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Av. Daily Volume 415,954
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ALRN-6924
Non-small cell lung cancer
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ALRN-6924
Small Cell Lung Cancer (SCLC)
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Latest News

  1. BOSTON, July 08, 2021 (GLOBE NEWSWIRE) -- Aileron Therapeutics (NASDAQ:ALRN), a chemoprotection oncology company focused on fundamentally transforming the experience of chemotherapy for cancer patients, announced today that Manuel Aivado, M.D., Ph.D., President and Chief Executive Officer, is scheduled to participate in a fireside chat at the William Blair Biotech Focus Conference 2021 at 3:00 p.m. ET on Thursday, July 15, 2021. Management will also be available for virtual 1x1 meetings from July 14-15.

    A webcast of the fireside chat will be available under the Investors and Media section of Aileron's website at https://investors.aileronrx.com. A replay of the webcast will be archived on Aileron's website for 30 days following the event…

    BOSTON, July 08, 2021 (GLOBE NEWSWIRE) -- Aileron Therapeutics (NASDAQ:ALRN), a chemoprotection oncology company focused on fundamentally transforming the experience of chemotherapy for cancer patients, announced today that Manuel Aivado, M.D., Ph.D., President and Chief Executive Officer, is scheduled to participate in a fireside chat at the William Blair Biotech Focus Conference 2021 at 3:00 p.m. ET on Thursday, July 15, 2021. Management will also be available for virtual 1x1 meetings from July 14-15.

    A webcast of the fireside chat will be available under the Investors and Media section of Aileron's website at https://investors.aileronrx.com. A replay of the webcast will be archived on Aileron's website for 30 days following the event.

    About Aileron

    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 activating p53, 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. This precision medicine-driven approach is designed to selectively protect multiple healthy cell types throughout the body from chemotherapy while ensuring we do not protect 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 by enabling them to better tolerate chemotherapy. It also may save patients' lives by helping them avoid life-threatening chemotherapy-related events such as severe neutropenia and febrile neutropenia. Additionally, 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 www.aileronrx.com to learn more.

    Investor Contacts:

    Aileron Therapeutics

    Richard Wanstall, SVP Chief Financial Officer

    617-995-0900



    Media Contact:

    Liz Melone

    617-256-6622

      
    Hans C. Vitzthum

    LifeSci Advisors, LLC.

    617-430-7578



     



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    • Phase 1b trial anticipated to enroll 60 patients with advanced p53-mutated NSCLC undergoing chemotherapy with first-line carboplatin plus pemetrexed
    • Study will evaluate proportion of treatment cycles free of severe hematological and other toxicities, transfusions and the use of growth factors, as well as the impact on quality of life
    • First interim safety data anticipated at the end of 2021 and final results mid-2022
    • ALRN-6924 uses p53 mutation as biomarker to ensure selective chemoprotection of healthy cells without protecting cancer cells
    • Nearly 1 million patients in the U.S. are diagnosed every year with p53-mutated cancer, including half of the approximately 190,000 NSCLC patients diagnosed in the U.S., annually1
    • Aileron plans to ultimately pursue…
    • Phase 1b trial anticipated to enroll 60 patients with advanced p53-mutated NSCLC undergoing chemotherapy with first-line carboplatin plus pemetrexed

    • Study will evaluate proportion of treatment cycles free of severe hematological and other toxicities, transfusions and the use of growth factors, as well as the impact on quality of life
    • First interim safety data anticipated at the end of 2021 and final results mid-2022
    • ALRN-6924 uses p53 mutation as biomarker to ensure selective chemoprotection of healthy cells without protecting cancer cells
    • Nearly 1 million patients in the U.S. are diagnosed every year with p53-mutated cancer, including half of the approximately 190,000 NSCLC patients diagnosed in the U.S., annually1
    • Aileron plans to ultimately pursue a tumor-agnostic indication for ALRN-6924 as chemoprotective agent for patients with p53-mutated cancer regardless of type of cancer or chemotherapy

    BOSTON, July 01, 2021 (GLOBE NEWSWIRE) --  Aileron Therapeutics, Inc. (NASDAQ:ALRN) today announced that it has initiated  a randomized, double-blind, placebo-controlled clinical trial in the US and in Europe of ALRN-6924 as a chemoprotective agent to treat patients with non-small cell lung cancer (NSCLC) undergoing chemotherapy. Aileron plans to enroll 60 patients with advanced p53-mutated NSCLC undergoing treatment with first-line carboplatin plus pemetrexed with or without immune checkpoint inhibitors in this Phase 1b trial. Aileron is developing ALRN-6924 to selectively protect healthy cells in patients with cancers that harbor p53 mutations to reduce or eliminate chemotherapy-induced side effects while preserving chemotherapy's attack on cancer cells, a concept known as chemoprotection.

    "We are pleased to initiate this trial, which builds on promising data we previously reported from our proof-of-concept trial of ALRN-6924 in patients with small cell lung cancer (SCLC)," said Manuel Aivado, M.D., Ph.D., President and CEO of Aileron. "This NSCLC trial represents important progress in our clinical development strategy, as it involves a p53-mutated cancer indication that affects one of the largest cancer patient populations, and it is our first randomized, double-blind, placebo-controlled trial. In addition, the trial is designed to help us further advance our ultimate goal of pursuing a tumor-agnostic indication for ALRN-6924 as a chemoprotective agent for patients with p53-mutated cancers regardless of type of cancer or chemotherapy, with the potential to help millions of patients."

    1 American Cancer Society

    Nashat Gabrail, M.D., founder of the Gabrail Cancer Center in Canton, Ohio, President of Innovative Community Oncology Practices (ICOP) and an investigator in the ALRN-6924 NSCLC trial, commented, "Proactively protecting patients against chemotherapy-induced toxicities that impact bone marrow cells and other cells throughout the body closely aligns with our mission to improve the health and quality of life for patients. This is a significantly unaddressed need impacting nearly every patient who undergoes chemotherapy. When devising treatment strategies for today's cancer patients, the use of targeted therapies is certainly preferred when possible. We are proud to participate in this trial to help explore the potential of ALRN-6924 as a novel chemoprotective agent that utilizes a biomarker-driven approach, thereby potentially bringing the promise of precision medicine to the field of supportive care drugs."

    Patients enrolled in Aileron's NSCLC trial will be randomized 1:1 to receive carboplatin/pemetrexed plus 0.3 mg/kg ALRN-6924 or placebo for at least four 21-day treatment cycles. Primary endpoints are the proportion of treatment cycles free of severe hematological and other toxicities, including Grade ≥ 3 neutropenia, Grade ≥ 3 thrombocytopenia, Grade ≥ 3 anemia, Grade 4 neutropenia and febrile neutropenia, as well as duration of Grade 4 neutropenia. An additional primary endpoint is the proportion of completed treatment cycles without chemotherapy dose reduction or without the use of growth factors or transfusions. Other endpoints include the proportion of patients with National Cancer Institute (NCI) Common Terminology Criteria Adverse Events (CTCAE) Grade 3/4 treatment-emergent adverse events (TEAEs), quality of life, overall response rate, and progression-free survival.

    Aileron anticipates reporting first interim safety data from the trial late in the fourth quarter of 2021 and full results in mid-2022.

    The NSCLC trial follows Aileron's presentation in October 2020 of clinical data from its completed Phase 1b clinical trial of ALRN-6924 in SCLC demonstrating clinical proof-of-concept that treatment with ALRN-6924 resulted in a protective effect against severe anemia, thrombocytopenia and neutropenia in patients with p53-mutated SCLC treated with topotecan.  A link to the SCLC presentation can be found here.

    About ALRN-6924

    Aileron is developing ALRN-6924, a novel chemoprotective medicine, to selectively protect healthy cells in patients with cancers that harbor p53 mutations to reduce or eliminate chemotherapy-induced side effects.

    Chemotherapy preferentially acts on cells that are cycling, i.e. undergoing the process of cell division. In cancer cells, the cell cycle is unchecked, 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 the gastrointestinal tract. As a result, chemotherapy preferentially targets and kills both cycling healthy cells and cycling cancer cells. This, in turn, can lead to a spectrum of chemotherapy-induced side effects, from unpleasant to life-threatening and fatal.  

    ALRN-6924, an investigational first-in-class MDM2/MDMX dual inhibitor, is administered prior to chemotherapy to patients with p53-mutant cancers. ALRN-6924 is designed to activate normal p53 protein in patients' healthy cells, temporarily and reversibly pausing cell cycling to selectively shield the patients' healthy cells from chemotherapy. The protection is limited to healthy cells, as ALRN-6924 cannot work in p53-mutated cancer cells given that mutated p53 has lost its function in those cells. Therefore, p53-mutated cancer cells continue to cycle uninterrupted and remain fully susceptible to being killed by chemotherapy.

    About Aileron

    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 activating p53, 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 precision medicine-driven strategy is designed to selectively protect multiple healthy cell types throughout the body from chemotherapy while ensuring we do not protect 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 by enabling them to better tolerate chemotherapy. It also may save patients' lives by helping them avoid life-threatening chemotherapy-related events such as severe neutropenia and febrile neutropenia. Additionally, 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 www.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 or with respect to the matters anticipated; whether results of clinical trials will be indicative of results obtained in later 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; whether, if ALRN-6924 obtains approval, it will be successfully distributed and marketed; uncertainties as to the 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 quarter ended March 31, 2021, filed on May 11, 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 Officer Liz Melone
    Aileron Therapeutics 617-256-6622
    617-995-0900
      

    Hans C. Vitzthum

    LifeSci Advisors, LLC.

    617-430-7578



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  2. BOSTON, June 24, 2021 (GLOBE NEWSWIRE) -- Aileron Therapeutics (NASDAQ:ALRN), a chemoprotection oncology company focused on fundamentally transforming the experience of chemotherapy for cancer patients, announced today that it is set to join the Russell Microcap® Index at the conclusion of the 2021 Russell indexes annual reconstitution, effective after the U.S. market opens on June 28, 2021.

    Membership in the Russell Microcap® Index, which remains in place for one year, means automatic inclusion in the appropriate growth and value style indexes. FTSE Russell determines membership for its Russell indexes primarily by objective, market-capitalization rankings and style attributes.

    "Protection against chemotherapy-induced toxicities represents…

    BOSTON, June 24, 2021 (GLOBE NEWSWIRE) -- Aileron Therapeutics (NASDAQ:ALRN), a chemoprotection oncology company focused on fundamentally transforming the experience of chemotherapy for cancer patients, announced today that it is set to join the Russell Microcap® Index at the conclusion of the 2021 Russell indexes annual reconstitution, effective after the U.S. market opens on June 28, 2021.

    Membership in the Russell Microcap® Index, which remains in place for one year, means automatic inclusion in the appropriate growth and value style indexes. FTSE Russell determines membership for its Russell indexes primarily by objective, market-capitalization rankings and style attributes.

    "Protection against chemotherapy-induced toxicities represents a significant, largely unaddressed need in the oncology space, and one for which there is now increasing progress and momentum," said Manuel Aivado, M.D., Ph.D., President and Chief Executive Officer at Aileron. "Precision medicine has truly revolutionized cancer treatment. In line with that transformation, our use of the p53 biomarker gives us the potential to selectively chemoprotect healthy cells in a very large number of patients given that nearly one million cancer patients are annually diagnosed with a p53-mutated cancer in the United States alone. Our inclusion in the Russell Microcap Index will expand our investor base as we work to transform the experience of cancer patients undergoing chemotherapy."

    Russell indexes are widely used by investment managers and institutional investors for index funds and as benchmarks for active investment strategies. Approximately $10.6 trillion in assets are benchmarked against Russell's US indexes. Russell indexes are part of FTSE Russell, a leading global index provider. For more information on the Russell Microcap® Index and the Russell indexes reconstitution, go to the "Russell Reconstitution" section on the FTSE Russell website.

    About Aileron

    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 activating p53, 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 while ensuring we do not protect 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 www.aileronrx.com to learn more.

    About FTSE Russell

    FTSE Russell is a global index leader that provides innovative benchmarking, analytics and data solutions for investors worldwide. FTSE Russell calculates thousands of indexes that measure and benchmark markets and asset classes in more than 70 countries, covering 98% of the investable market globally.

    FTSE Russell index expertise and products are used extensively by institutional and retail investors globally. Approximately $17.9 trillion is currently benchmarked to FTSE Russell indexes. For over 30 years, leading asset owners, asset managers, ETF providers and investment banks have chosen FTSE Russell indexes to benchmark their investment performance and create ETFs, structured products and index-based derivatives.

    A core set of universal principles guides FTSE Russell index design and management: a transparent rules-based methodology is informed by independent committees of leading market participants. FTSE Russell is focused on applying the highest industry standards in index design and governance and embraces the IOSCO Principles. FTSE Russell is also focused on index innovation and customer partnerships as it seeks to enhance the breadth, depth and reach of its offering.

    FTSE Russell is wholly owned by London Stock Exchange Group.

    For more information, visit www.ftserussell.com.

    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 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; 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 quarterly report on Form 10-Q for the quarter ended March 31, 2021, filed on May 11, 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
    617-995-0900
     
      
    Hans C. Vitzthum 
    LifeSci Advisors, LLC. 
    617-430-7578 
     



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  3. -- Fireside chat, moderated by Soumit Roy, Ph.D. of JonesTrading, will be held on Wednesday, May 26, 2021 at 11:00 am ET --

    -- Featured speakers will include hematologist Alan List, M.D. and geriatric oncologist Lodovico Balducci, M.D. --

    BOSTON, May 19, 2021 (GLOBE NEWSWIRE) -- Aileron Therapeutics (NASDAQ:ALRN), a chemoprotection oncology company focused on fundamentally transforming the experience of chemotherapy for cancer patients, announced today that it will host a key opinion leader (KOL) investor event focused on the topic of protecting cancer patients from chemotherapy-induced toxicities on Wednesday, May 26, 2021 at 11:00 am ET.

    The fireside chat, moderated by Soumit Roy, Ph.D., Managing Director at JonesTrading, will feature…

    -- Fireside chat, moderated by Soumit Roy, Ph.D. of JonesTrading, will be held on Wednesday, May 26, 2021 at 11:00 am ET --

    -- Featured speakers will include hematologist Alan List, M.D. and geriatric oncologist Lodovico Balducci, M.D. --

    BOSTON, May 19, 2021 (GLOBE NEWSWIRE) -- Aileron Therapeutics (NASDAQ:ALRN), a chemoprotection oncology company focused on fundamentally transforming the experience of chemotherapy for cancer patients, announced today that it will host a key opinion leader (KOL) investor event focused on the topic of protecting cancer patients from chemotherapy-induced toxicities on Wednesday, May 26, 2021 at 11:00 am ET.

    The fireside chat, moderated by Soumit Roy, Ph.D., Managing Director at JonesTrading, will feature Alan List, M.D. and Lodovico Balducci, M.D., discussing the unmet need in addressing chemotherapy-induced toxicities, the resulting medical impact and quality-of-life burden on cancer patients, as well as the opportunity for a new paradigm known as chemoprotection that focuses on proactive prevention.

    Dr. List is a hematologist and physician scientist who is internationally recognized for his many contributions in the development of more effective treatment strategies for myeloid and other malignancies. He is the author of more than 450 peer-reviewed manuscripts, chapters and books, and is the former President and CEO of Moffitt Cancer Center, and past president of the Society of Hematologic Oncology. Currently, Dr. List serves as Chief Medical Officer at Precision Biosciences. Dr. Balducci, a renowned geriatric oncologist, was formerly a Senior Member of the Senior Adult Oncology Program and Medical Director of Affiliates & Referring Physician Relations at Moffitt Cancer Center, and Professor of Oncologic Sciences, University of South Florida College of Medicine, in Tampa, Florida.

    A webcast of the event will be available under the Investors and Media section on Aileron's website at https://investors.aileronrx.com/. A replay of the webcast will be archived on Aileron's website for 90 days following the event.

    To register for the event, please click here.

    Aileron's first-in-class dual MDM2/MDMX inhibitor, ALRN-6924, is currently in clinical development as a therapeutic agent designed to deliver selective chemoprotection for patients with p53-mutated cancers. 50% of all cancer patients have p53-mutated cancer.

    ALRN-6924 has demonstrated a protective effect against chemotherapy-induced bone marrow toxicities, including neutropenia, thrombocytopenia and anemia, in a Phase 1b trial in patients with p53-mutated small cell lung cancer (SCLC) undergoing treatment with topotecan in second line of therapy. In the second quarter of 2021, Aileron plans to initiate a Phase 1b randomized, placebo-controlled trial of ALRN-6924 in patients with p53-mutated non-small cell lung cancer (NSCLC) who are receiving first-line carboplatin plus pemetrexed (with or without immune checkpoint inhibitors).

    About Aileron

    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 activating p53, 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 while ensuring we do not protect 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. 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; 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 March 31, 2021, filed on May 11, 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
    617-995-0900
     
      
    Hans C. Vitzthum 
    LifeSci Advisors, LLC. 
    617-430-7578 
     


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    • Progressing ALRN-6924: on track to initiate Phase 1b randomized placebo-controlled trial in patients with p53-mutated non-small cell lung cancer in 2nd quarter 2021 with early interim read-out expected at end of 2021

    --

    • ALRN-6924 is designed to deliver selective chemoprotection against chemotherapy-induced toxicities via p53 biomarker strategy
      • 50% of all cancer patients across multiple tumor types have a p53 mutation

    --

    • Abstract co-authored with Foundation Medicine evaluating frequency of longitudinal changes in TP53 mutation status accepted for presentation at 2021 ASCO Annual Meeting

    --

    • Aileron to host KOL Fireside Chat moderated by Soumit Roy, Ph.D., Vice President, Healthcare Analyst with JonesTrading, on May 26, 2021
      • Event will
    • Progressing ALRN-6924: on track to initiate Phase 1b randomized placebo-controlled trial in patients with p53-mutated non-small cell lung cancer in 2nd quarter 2021 with early interim read-out expected at end of 2021

    --

    • ALRN-6924 is designed to deliver selective chemoprotection against chemotherapy-induced toxicities via p53 biomarker strategy
      • 50% of all cancer patients across multiple tumor types have a p53 mutation

    --

    • Abstract co-authored with Foundation Medicine evaluating frequency of longitudinal changes in TP53 mutation status accepted for presentation at 2021 ASCO Annual Meeting

    --

    • Aileron to host KOL Fireside Chat moderated by Soumit Roy, Ph.D., Vice President, Healthcare Analyst with JonesTrading, on May 26, 2021
      • Event will feature renowned hematologist Alan List, M.D. and prominent geriatric oncologist Lodovico Balducci, M.D.

    BOSTON, May 11, 2021 (GLOBE NEWSWIRE) -- Aileron Therapeutics (NASDAQ:ALRN), a chemoprotection oncology company focused on fundamentally transforming the experience of chemotherapy for cancer patients, today reported business highlights and financial results for the first quarter ended March 31, 2021.

    "We continue to work diligently to initiate our first randomized, double-blind, placebo-controlled clinical trial of ALRN-6924 as a novel therapeutic to protect non-small cell lung cancer (NSCLC) patients receiving first-line chemotherapy against various chemotherapy-induced toxicities. Approximately 50% of NSCLC patients have a p53 mutation, suggesting the broad potential impact of ALRN-6924 in this indication alone," said Manuel Aivado, M.D., Ph.D., President and Chief Executive Officer.

    Dr. Aivado further commented, "Simultaneously, we are actively planning for the rapid advancement of ALRN-6924 into late-stage development for patients with p53-mutated NSCLC pending the outcome of the Phase 1b trial. Bolstered by our successful capital raises in the first quarter of 2021, we are making near-term strategic investments in CMC, p53 companion diagnostic development, and team scale-up which we expect will not only enable the future advancement of our NSCLC clinical program, but also will provide foundational support for future clinical programs of ALRN-6924 across multiple p53-mutated cancer indications."

    Aileron is developing ALRN-6924 to selectively protect healthy cells in patients with cancers that harbor p53 mutations, which are present in over half of all cancer patients, to reduce or eliminate chemotherapy-induced side effects while not interfering with chemotherapy's attack on cancer cells. This novel concept is known as chemoprotection. 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 as a result. Given Aileron's p53 biomarker approach, designed to ensure selective chemoprotection only in healthy cells, coupled with the high prevalence of p53-mutated cancers, the company's strategy is to ultimately pursue a tumor-agnostic label for ALRN-6924 as a chemoprotective agent in p53-mutated cancers.

    First Quarter 2021 Highlights and Recent Updates

    • Aileron to host upcoming KOL Fireside Chat, "Protecting Cancer Patients from Chemotherapy-Induced Toxicities - A New Paradigm". Moderated by Soumit Roy, Ph.D., Vice President, Healthcare Analyst with JonesTrading Institutional Services LLC, the event will include a discussion on the unmet need and potential for chemoprotection with Alan List, M.D. and Lodovico Balducci, M.D. Dr. List, who recently was appointed Chief Medical Officer of Precision Biosciences, is a renowned hematologist with extensive academic and clinical experience in the research and development of hematology and oncology products. Dr. List is also a member of Aileron's Scientific Advisory Board. Dr. Balducci, a prominent geriatric oncologist, previously served as Senior Member of the Senior Adult Oncology Program and Medical Director of Affiliates and Referring Physician Relations at the Moffitt Cancer Center. Link here to register for the event, which will take place on Wednesday, May 26, 2021.

    • Abstract co-authored by Aileron and Foundation Medicine, Inc. to be presented at 2021 ASCO Annual Meeting. The abstract, titled, "Gene Sequencing of Serial Tumor Biopsies from a Large Cohort of Cancer Patients Shows Longitudinal Changes in TP53 Mutation Status Are Uncommon" (Abstract #3124), was accepted as a poster presentation at the meeting. Additional details will be announced upon ASCO's online publication of this year's abstracts later this month.

    • Announced enrollment expansion for upcoming Phase 1b clinical trial of ALRN-6924 in patients with advanced NSCLC. In February 2021, Aileron announced a 50% expansion of its enrollment target for its upcoming Phase 1b clinical trial of ALRN-6924 in patients with NSCLC undergoing chemotherapy. Aileron plans to enroll 60 patients with advanced p53-mutated NSCLC undergoing treatment with first-line carboplatin plus pemetrexed (with or without immune checkpoint inhibitors). Aileron anticipates this enrollment expansion will enable a more robust exploration of ALRN-6924 as a novel chemoprotective agent to prevent chemotherapy-induced toxicities in the NSCLC patient population and better position the company to rapidly advance ALRN-6924 into late-stage clinical development for NSCLC following the Phase 1b trial.



      In the Phase 1b NSCLC trial, patients will be randomized 1:1 to receive either carboplatin/pemetrexed plus 0.3 mg/kg ALRN-6924 or carboplatin/pemetrexed plus placebo for at least four 21-day treatment cycles. Evaluations will include the proportion of treatment cycles free of severe hematological and other toxicities, transfusions and the use of growth factors, as well as the impact on quality of life. Aileron plans to initiate the NSCLC trial in the second quarter of 2021 and anticipates reporting early interim data at the end of 2021 and topline results in mid-2022.
    • During the first quarter, Aileron completed its Phase 1b evaluation of ALRN-6924 at the recommended phase 2 dose of 0.3 mg/kg in patients with SCLC receiving ALRN-6924 24-hours prior to topotecan and conducted preliminary evaluation of data from additional cohorts. These preliminary findings from 11 additional patients (n=7 patients receiving 0.3 mg/kg ALRN-6924 six hours before topotecan and n=4 patients receiving 0.2 mg/kg ALRN-6924 twenty-four hours before topotecan) were in line with data presented last October and with Aileron's expectation that administering ALRN-6924 at 0.3mg/kg and 24 hours before topotecan remains the optimal dose and schedule in this patient population. Aileron expects to present results of the Phase 1b SCLC trial at a scientific conference in the second half of 2021.



    • Raised $55.7 million in aggregate proceeds from the sale of common stock during first quarter 2021, which based on Aileron's current operating plan, is expected to provide funding into the second half of 2023 and approximately 12 months beyond the anticipated topline results from the NSCLC trial. In January 2021, Aileron completed a registered direct offering of common stock, for a purchase price of $1.10 per share, raising $33.1 million in aggregate net proceeds, after deducting placement agent fees and other offering expenses payable by Aileron. New fundamental and institutional investors, including Acorn Bioventures, BVF Partners, L.P., 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. In addition to the registered direct offering, since January 1, 2021, Aileron sold an aggregate of 13,775,399 shares of its common stock for an average purchase price of $1.64 per share, for aggregate net proceeds of $22.6 million, after deducting fees and offering expenses, in "at the market" offerings and under its structured equity line with Lincoln Park Capital Fund, LLC.

    • Continuing healthy volunteer study to support long-term clinical development strategy for ALRN-6924. The ongoing study, initiated in November 2020, is designed to characterize the time to onset, magnitude, and duration of cell cycle arrest in human bone marrow relative to ALRN-6924 administration. Another goal of the study is to develop a universal dosing regimen for ALRN-6924 for use as a chemoprotection agent across a range of chemotherapies and p53-mutated tumor indications. Aileron expects to present results from the healthy volunteer study at a scientific conference in the second half of 2021.

    First Quarter 2021 Financial Results

    • Cash Position: Cash, cash equivalents and investments at March 31, 2021 were $63.4 million, compared to $13.8 million at December 31, 2020. The company expects, based on its current operating plan, that its existing cash, cash equivalents and investments will fund operations into the second half of 2023.



    • Research and Development (R&D) Expenses: R&D expenses for the quarter ended March 31, 2021 were $4.3 million, compared to $4.1 million for the corresponding quarter in 2020. The increase of $0.2 million is primarily a result of increased spending on clinical development of ALRN-6924 in connection with the preparation for the upcoming Phase 1b clinical trial in patients with advanced NSCLC patients being treated with first-line chemotherapy of carboplatin and pemetrexed and is partially offset by the effect of cost savings measures implemented in 2020 resulting in decreased spending on employee, facility and other development expenses.



    • General and Administrative (G&A) Expenses: G&A expenses for the quarter ended March 31, 2021 were $2.7 million, compared to $2.8 million for the corresponding quarter in 2020. The decrease in general and administrative expense is the result of lower headcount and facility costs during the three months ended March 31, 2021 as a result of cost savings measures as compared to the three months ended March 31, 2020 and is partially offset by increased spending on professional services.



    • Net Loss: Net loss for the quarter ended March 31, 2021 was $7.0 million, compared to $6.7 million for the corresponding quarter in 2020. The basic and diluted net loss per share for the first quarter of 2021 was $0.08 compared to $0.24 for the first quarter of 2020. The change in basic and diluted net loss per share is primarily a result of increased shares outstanding in connection with sales of common stock during the first quarter of 2021.

    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 activating p53, 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 while ensuring we do not protect 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. 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; 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 March 31, 2021, filed on May 11, 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
    617-995-0900
     
      
    Hans C. Vitzthum 
    LifeSci Advisors, LLC. 
    617-430-7578 
     



     
    Aileron Therapeutics, Inc.
    Balance Sheet Data
    (In thousands)
        
     March 31,

    2021
     December 31,

    2020
        
    Cash, cash equivalents and investments$63,351  $13,805 
    Working capital 61,251   12,366 
    Total assets 64,671   16,341 
    Accumulated deficit (226,267)  (219,292)
    Total stockholders' equity 61,419   12,162 



     
    Aileron Therapeutics, Inc.
    Condensed Statement of Operations
    (In thousands, except share and per share data)
        
        
     Three Months Ended March 31,
      2021   2020 
        
    Revenue$-    $-   
    Operating expenses:   
    Research and development 4,316   4,069 
    General and administrative 2,673   2,807 
    Total Operating expenses 6,989   6,876 
    Loss from operations (6,989)  (6,876)
    Interest and other income 14   128 
    Net loss (6,975)  (6,748)
    Net loss per share — basic and diluted$(0.08) $(0.24)
    Weighted average common shares outstanding—basic and diluted 83,384,371   27,810,358 


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