CAMBRIDGE, Mass.–(BUSINESS THREAD)–Axcella Therapeutics (Nasdaq: AXLA), a clinical-stage biotechnology company pioneering a new approach to treating complex diseases using multi-targeted endogenous metabolic modulator (EMM) compounds, today announced financial results for the second quarter ended on June 30, 2022. and provided a business update.
“Axcella has been a leader in clinical development in Long COVID. We continued this leadership in the second quarter as we advanced the development of our two clinical programs for AXA1125. Our phase 2A trial of Long COVID in collaboration with the University of Oxford has now been completed. The results were extremely encouraging and showed that administering AXA1125 to patients significantly reduced mental and physical fatigue,” said Bill Hinshaw, president and CEO of Axcella. “Since we reported our data on last week, we received extremely positive feedback from our physician and patient community about their excitement for the development of this therapeutic and its potential to benefit patients once it reaches the clinic. In addition, we continue to participate in investor meetings to bring the company’s story to the broader investment community.”
Financial results
Cash position: As of June 30, 2022, cash, cash equivalents and marketable securities totaled $44.4 million, compared to $55.0 million as of December 31 2021. In March 2022, the Company received approximately $25.0 million in gross proceeds from a registered direct investment. offering of common shares. Axcella expects that its current cash balance will be sufficient to meet its operating needs during the first quarter of 2023, provided that, if the Company is unable to satisfy the cash covenants contained in its loan and security agreement with SLR Investment Corp. and SLR Investment Corp. seeks immediate repayment of the loan in full, the Company believes that its cash and cash equivalents will be sufficient to finance its operations during the fourth quarter of 2022.
R&D Expenses: Research and development expenses for the quarter and six months ended June 30, 2022 were $16.9 million and $30.4 million, respectively. Research and development expenses for the same periods ended June 30, 2021 were $10.3 million and $20.5 million, respectively. These increases are the result of the company’s EMMPACT and Long COVID Phase 2 clinical trials, as well as the closing costs of its EMMPOWER Phase 2 clinical trial.
General and administrative expenses for the quarter and six months ended June 30, 2022 were $3.8 million and $8.5 million, respectively. General and administrative expenses for the same periods ended June 30, 2021 were $4.9 million and $9.2 million. These decreases are primarily the result of lower non-cash stock-based compensation expense.
Net Loss: Net loss for the quarter and six months ended June 30, 2022 was $21.3 million, or $0.40 per basic and diluted share, and $40.3 million, or 0 $.86 per basic and diluted share, respectively. This compares to a net loss of $15.9 million, or $0.42 per basic and diluted share, and $31.1 million, or $0.83 per basic and diluted share, for the six-month period months ended June 30, 2021.
Publication of information on the Internet
Axcella uses the “Investors and News” section of its website, www.axcellatx.com, as a means to disclose material non-public information, to communicate with investors and the public, and to comply with its disclosure obligations under Regulation FD. These disclosures include, but are not limited to, investor presentations and frequently asked questions, Securities and Exchange Commission filings, press releases and public conferences and webcasts. The information we publish on our website may be considered material information. As a result, we encourage investors, the media and other interested parties to review the information we publish there on a regular basis. The content of our website will not be deemed incorporated by reference into any filing under the Securities Act of 1933, as amended.
About Axcella Therapeutics (Nasdaq: AXLA)
Axcella is a clinical-stage biotechnology company pioneering a novel approach to treating complex diseases using endogenous metabolic modulator (EMM) compositions. The Company’s product candidates consist of EMMs and derivatives designed in various combinations and proportions to restore cellular homeostasis in multiple key biological pathways and improve cellular energy efficiency. Axcella’s pipeline includes lead therapeutic candidates in Phase 2 development for the treatment of Long COVID and non-alcoholic steatohepatitis (NASH). The Company’s unique model enables the evaluation of its EMM compositions through non-IND clinical studies or IND clinical trials. For more information, visit www.axcellatx.com.
Forward-looking statements
This press release contains forward-looking statements within the meaning of the Private Securities Litigation Reform Act of 1995, as amended, including, without limitation, statements regarding the timing of the Company’s clinical trial data readings, its expected lead to cash and the potential impact of the Company’s recent clinical trial data readings on market interest and acceptance of the Company’s product candidates and investment interest in the Company’s securities company The words “may”, “could”, “could”, “should”, “expect”, “plan”, “anticipate”, “attempt”, “believe”, “estimate”, “predict” The expressions “project “, “potential”, “continue”, “target” and the like are intended to identify forward-looking statements, although not all forward-looking statements contain such identifying words. Any forward-looking statements in this press release are based on management’s current expectations and beliefs and are subject to a number of risks, uncertainties and important factors that could cause actual events or results to differ materially from those expressed or implied by any future projection statements contained in this press release, including, without limitation, those related to the potential impact of COVID-19 on the Company’s ability to conduct and complete its ongoing or planned clinical studies and clinical trials of timely or at all due to patient or principal investigator recruitment or availability challenges, clinical trial site closures or other potential disruptions and limitations on the quality, integrity and interpretability of the data that the Company may collect in its clinical trials of AXA1125, other potential impacts of COVID-19 on the company’s business. and financial results, including with respect to our ability to raise additional capital and operational disruptions or delays, changes in laws, regulations or interpretations and enforcement of regulatory guidance, whether data readings support plans and timing of the Company’s clinical trials, the clinical trial design and target indications for AXA1125, the clinical development and safety profile of AXA1125 and its therapeutic potential, if and when, if applicable, the candidates for the the Company’s product will receive approval from the FDA or other comparable regulatory authorities, potential competition from other biopharmaceutical companies in the Company’s target indications and other risks identified in the Company’s SEC filings , including Axcella’s Annual Report on Form 10-K, Quarterly Report on Form 10-Q and subsequent filings with the SEC. The Company cautions you not to place undue reliance on forward-looking statements, which speak only as of the date they are made. Axcella disclaims any obligation to publicly update or revise these statements to reflect any changes in expectations or in the events, conditions or circumstances on which such statements may be based, or which may affect the likelihood that actual results will differ from those stated in the forward-looking statements. Any forward-looking statements contained in this press release represent the company’s views only as of the date hereof and should not be deemed to represent its views as of a later date. The Company expressly disclaims any obligation to update any forward-looking statements.
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