Aileron Therapeutics(ALRN) - 2022 Q1 - Quarterly Report

Financial Performance - The company reported net losses of $8.4 million for Q1 2022, compared to $7.0 million for Q1 2021, with an accumulated deficit of $253.9 million as of March 31, 2022[115]. - The net loss for the three months ended March 31, 2022, was $8.4 million, compared to a net loss of $7.0 million for the same period in 2021, reflecting an increase in loss of $1.4 million[155]. - Cash used in operating activities was $7.8 million for the three months ended March 31, 2022, compared to $6.5 million for the same period in 2021, indicating an increase of $1.3 million[154]. - General and administrative expenses decreased to $2.5 million for the three months ended March 31, 2022, down from $2.7 million in the same period of 2021, a reduction of $0.2 million[137]. - Research and development expenses increased to $5.9 million for the three months ended March 31, 2022, up from $4.3 million in the same period of 2021, representing a $1.6 million increase[136]. Revenue Generation - The company has not generated any revenue from product sales and does not expect to do so in the near future[122]. - The company has not yet commercialized any product candidate and does not expect to generate revenue from product sales for several years[141]. - The company’s commercial revenues, if any, will be derived from sales of drugs that are not expected to be commercially available for many years[164]. Funding and Capital Requirements - As of March 31, 2022, the company had cash, cash equivalents, and investments totaling $38 million, expected to fund operations into Q4 2023[118]. - The company may need to seek additional financing through public or private equity offerings, collaborations, or licensing arrangements to support operations beyond Q4 2023[116]. - The company currently has no committed external source of funds, which may limit its ability to raise additional capital[165]. - The company may need to obtain further funding through public or private equity offerings or collaborations to finance its operations[160]. - The company raised $35.9 million from a registered direct offering in January 2021, selling 32,630,983 shares at $1.10 per share[142]. - Future capital requirements will depend on the scope, progress, results, and costs of ongoing and planned clinical trials for ALRN-6924, as well as the impact of the COVID-19 pandemic[161]. - The company is unable to estimate the timing and amounts of increased capital outlays and operating expenses for the development of ALRN-6924 due to numerous risks and uncertainties[161]. Clinical Development - The company plans to expand its clinical program for ALRN-6924 to evaluate its effectiveness across additional p53-mutated tumor types and chemotherapy regimens, subject to obtaining additional funding[112]. - The ongoing Phase 1b clinical trial of ALRN-6924 in patients with advanced p53-mutated non-small cell lung cancer (NSCLC) has been impacted by COVID-19, resulting in slower-than-anticipated patient enrollment[121]. - The company anticipates significant increases in expenses related to ongoing development activities for ALRN-6924 and other potential product candidates[158]. - The company may need to delay or limit product development programs if unable to raise additional funds when needed[167]. - The costs and timing of future commercialization activities for any product candidate will depend on marketing approval and may not be the responsibility of any collaborator[163]. Risks and Uncertainties - The company cautions that forward-looking statements regarding future performance may not be guaranteed and actual results may differ materially[108]. - If the company raises additional funds through collaborations or licensing arrangements, it may have to relinquish valuable rights to its technology or future revenue streams[167]. - The preparation of financial statements requires estimates and assumptions that may materially affect reported financial condition and results of operations[168]. - A deficiency letter was received from Nasdaq regarding the bid price for common stock closing below the minimum $1.00 per share requirement for continued inclusion[166]. - The company has incurred significant losses primarily due to research and development activities, licensing, patent investments, and general administrative costs[115].