Tag: Axcella Therapeutics

Friday, March 31, 2023

Axcella is a clinical-stage biotechnology company pioneering a new approach to treat complex diseases using compositions of endogenous metabolic modulators (EMMs). The company’s product candidates are comprised of EMMs and derivatives that are engineered in distinct combinations and ratios to restore cellular homeostasis in multiple key biological pathways and improve cellular energetic efficiency. Axcella’s pipeline includes lead therapeutic candidates in Phase 2 development for the treatment of Long COVID and non-alcoholic steatohepatitis (NASH), and the reduction in risk of overt hepatic encephalopathy (OHE) recurrence. The company’s unique model allows for the evaluation of its EMM compositions through non-IND clinical studies or IND clinical trials. For more information, please visit www.axcellatx.com.

Robert LeBoyer, Vice President, Research Analyst, Life Sciences , Noble Capital Markets, Inc.

Refer to the full report for the price target, fundamental analysis, and rating.

4Q22 Reported.  Axcella Health reported a 4Q22 loss of $23.0 million or $(0.33) per share and a FY2022 loss of $81.2 million or $(1.49) per share. The 4Q loss included restructuring and impairment charges of $4.2 million. Since the restructuring, Axcella has made significant progress transforming AXA1125 from Phase 2a data into an approved IND for a Phase 2b/3 clinical trial.  The company ended FY2023 with $17.1 million in cash.

Long COVID Trial Is “Phase 2b/3 Ready”. In February 2023, Axcella announced the FDA accepted its IND for a Phase 2b/3 pivotal study testing AXA1125 in Long COVID. The design of the study was based on the results of its Phase 2a placebo-controlled trial in Long COVID announced in August 2022. The Phase 2a data showed statistically significant results in mental and physical fatigue scores. Although an experimental biomarker endpoint in muscle recovery was not met, the FDA accepted the IND for a Phase 2b/3 trial.

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This Company Sponsored Research is provided by Noble Capital Markets, Inc., a FINRA and S.E.C. registered broker-dealer (B/D).

*Analyst certification and important disclosures included in the full report. NOTE: investment decisions should not be based upon the content of this research summary. Proper due diligence is required before making any investment decision. 

Friday, February 17, 2023

Axcella is a clinical-stage biotechnology company pioneering a new approach to treat complex diseases using compositions of endogenous metabolic modulators (EMMs). The company’s product candidates are comprised of EMMs and derivatives that are engineered in distinct combinations and ratios to restore cellular homeostasis in multiple key biological pathways and improve cellular energetic efficiency. Axcella’s pipeline includes lead therapeutic candidates in Phase 2 development for the treatment of Long COVID and non-alcoholic steatohepatitis (NASH), and the reduction in risk of overt hepatic encephalopathy (OHE) recurrence. The company’s unique model allows for the evaluation of its EMM compositions through non-IND clinical studies or IND clinical trials. For more information, please visit www.axcellatx.com.

Robert LeBoyer, Vice President, Research Analyst, Life Sciences , Noble Capital Markets, Inc.

Refer to the full report for the price target, fundamental analysis, and rating.

Regulatory Pathway Clarified For AXA1125. Axcella announced acceptance of its IND for a Phase 2b/3 trial testing AXA1125 in Long COVID.  As a newly recognized condition with no approved drugs, the requirements for clinical trials and regulatory approval were unknown. We view the announcement as significant milestone that establishes the regulatory pathway for AXA1125 in Long COVID. The proposed trial has been accepted for both US and UK regulatory approval, allowing Axcella to move the program forward.

Conference Call Reiterates Details For Long Covid Trial As anticipated, the FDA and MHRA will accept a single, placebo-controlled study for regulatory approval in the US and UK.  The study will include endpoints to assess mental and physical functions that are common symptoms of Long COVID.  The planned enrollment is about 300 patients, with a treatment period of 3 months.

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Equity Research is available at no cost to Registered users of Channelchek. Not a Member? Click ‘Join’ to join the Channelchek Community. There is no cost to register, and we never collect credit card information.

This Company Sponsored Research is provided by Noble Capital Markets, Inc., a FINRA and S.E.C. registered broker-dealer (B/D).

*Analyst certification and important disclosures included in the full report. NOTE: investment decisions should not be based upon the content of this research summary. Proper due diligence is required before making any investment decision. 

Thursday, February 16, 2023

Axcella is a clinical-stage biotechnology company pioneering a new approach to treat complex diseases using compositions of endogenous metabolic modulators (EMMs). The company’s product candidates are comprised of EMMs and derivatives that are engineered in distinct combinations and ratios to restore cellular homeostasis in multiple key biological pathways and improve cellular energetic efficiency. Axcella’s pipeline includes lead therapeutic candidates in Phase 2 development for the treatment of Long COVID and non-alcoholic steatohepatitis (NASH), and the reduction in risk of overt hepatic encephalopathy (OHE) recurrence. The company’s unique model allows for the evaluation of its EMM compositions through non-IND clinical studies or IND clinical trials. For more information, please visit www.axcellatx.com.

Robert LeBoyer, Vice President, Research Analyst, Life Sciences , Noble Capital Markets, Inc.

Refer to the full report for the price target, fundamental analysis, and rating.

IND Cleared For Phase 2b/3. Axcella Health announced that its IND submission for a Phase 2b/3 trial for AXA1125 in Long COVID Fatigue has been cleared by the FDA. This trial has been designed as a registrational trial to support an NDA filing. In January 2023, Axcella announced the UK’s MHRA (Medicines and Health Regulatory Agency) gave guidance that that a single trial could serve as a registrational trial. Axcella now has clearance in both the US and UK that allows AXA1125 to move forward as planned.

Phase 2b/3 Trial Design. The placebo-controlled trial has a projected enrollment of 300 patients. Patients will be treated for 12 weeks, compared with 4 weeks in the Phase 2a trial. The primary endpoint will be the CFQ11, an accepted clinical tool for measuring fatigue. Secondary endpoints will include the PROMIS questionnaire to measure pain, fatigue, physical function, emotional distress, and ability to return to work.

Get the Full Report

Equity Research is available at no cost to Registered users of Channelchek. Not a Member? Click ‘Join’ to join the Channelchek Community. There is no cost to register, and we never collect credit card information.

This Company Sponsored Research is provided by Noble Capital Markets, Inc., a FINRA and S.E.C. registered broker-dealer (B/D).

*Analyst certification and important disclosures included in the full report. NOTE: investment decisions should not be based upon the content of this research summary. Proper due diligence is required before making any investment decision. 

Wednesday, January 25, 2023

Axcella is a clinical-stage biotechnology company pioneering a new approach to treat complex diseases using compositions of endogenous metabolic modulators (EMMs). The company’s product candidates are comprised of EMMs and derivatives that are engineered in distinct combinations and ratios to restore cellular homeostasis in multiple key biological pathways and improve cellular energetic efficiency. Axcella’s pipeline includes lead therapeutic candidates in Phase 2 development for the treatment of Long COVID and non-alcoholic steatohepatitis (NASH), and the reduction in risk of overt hepatic encephalopathy (OHE) recurrence. The company’s unique model allows for the evaluation of its EMM compositions through non-IND clinical studies or IND clinical trials. For more information, please visit www.axcellatx.com.

Robert LeBoyer, Vice President, Research Analyst, Life Sciences , Noble Capital Markets, Inc.

Refer to the full report for the price target, fundamental analysis, and rating.

Regulators Agree With Axcella’s Plan For A Phase 2b/3 Clinical Trial. Axcella Heath announced that US and UK regulators have agreed to a plan for a global Phase 2b/3 study of AXA1125 in Long COVID-19 patients. An IND has been submitted to the FDA for trials in the US, and agreement from the UK regulators has been received.  The Phase 2b/3 trial will include other countries to support worldwide approvals.  We see this as an important milestone for AXA1125 and the future of the company.

The Trial Announcement Reduces Uncertainty Around AXA1125.  As discussed in our Research Note on August 3, results from the Phase 2a trial in Long COVID showed a significant improvement in the physical fatigue, mental fatigue, and the 6-minute walk test. In December 2022, the company restructured to preserve cash, raising uncertainty about further development for the drug. The announcement of the Phase 2b/3 IND submission provides a development plan, allowing investors to assess timeframes and progress toward the market.

Get the Full Report

Equity Research is available at no cost to Registered users of Channelchek. Not a Member? Click ‘Join’ to join the Channelchek Community. There is no cost to register, and we never collect credit card information.

This Company Sponsored Research is provided by Noble Capital Markets, Inc., a FINRA and S.E.C. registered broker-dealer (B/D).

*Analyst certification and important disclosures included in the full report. NOTE: investment decisions should not be based upon the content of this research summary. Proper due diligence is required before making any investment decision. 

Wednesday, November 02, 2022

Axcella is a clinical-stage biotechnology company pioneering a new approach to treat complex diseases using compositions of endogenous metabolic modulators (EMMs). The company’s product candidates are comprised of EMMs and derivatives that are engineered in distinct combinations and ratios to restore cellular homeostasis in multiple key biological pathways and improve cellular energetic efficiency. Axcella’s pipeline includes lead therapeutic candidates in Phase 2 development for the treatment of Long COVID and non-alcoholic steatohepatitis (NASH), and the reduction in risk of overt hepatic encephalopathy (OHE) recurrence. The company’s unique model allows for the evaluation of its EMM compositions through non-IND clinical studies or IND clinical trials. For more information, please visit www.axcellatx.com.

Robert LeBoyer, Vice President, Research Analyst, Life Sciences , Noble Capital Markets, Inc.

Refer to the full report for the price target, fundamental analysis, and rating.

Financial Results.  Axcella reported a 3Q22 loss of $17.8 million or $(0.34) per share, compared with our estimate of a loss of $21.7 million or $(0.43) per share.  The company sold convertible notes raising $6.0 million to end the quarter with $25.4 million in cash and equivalents.  After the quarter ended, it added $28.2 million in cash through a direct offering of common stock.  Based on our 4Q22 estimate of a loss of $18.1 million, we project the cash balance at YE22 to be around $35.5 million.

Long COVID Study Results Were Encouraging.  Results from a Phase 2a study testing AXA1125 in Long COVID were announced in early August, as discussed in our note from August 3. The data showed statistically significant improvements in both physical and mental fatigue symptoms.  We believe this is clinically relevant for an estimated 20% to 30% of the people who have been infected with COVID-19.  Axcella is in currently in discussions with regulatory authorities to design the next study, planned to begin in 2023.

Get the Full Report

This Company Sponsored Research is provided by Noble Capital Markets, Inc., a FINRA and S.E.C. registered broker-dealer (B/D).

*Analyst certification and important disclosures included in the full report. NOTE: investment decisions should not be based upon the content of this research summary. Proper due diligence is required before making any investment decision.