Axcella Reports Second Quarter Financial Results and Provides Business Update
- Initiated EMMPOWER Phase 2 clinical trial of AXA1665 for the reduction in risk of recurrent OHE
- Initiated EMMPACT Phase 2b clinical trial of AXA1125 for the treatment of NASH
- Presented data at key medical congresses
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Enhanced management team with the addition of
Chief People Officer -
Company to host conference call at
8:30 a.m. ET today
“Thanks to solid execution on the part of our team, Axcella has rapidly advanced the development of its multi-targeted EMM compositions in order to address significant unmet needs for patients with complex diseases,” said
Recent Accomplishments
AXA1665 for the Reduction in Risk of Recurrent OHE
- Initiated EMMPOWER Clinical Trial: Axcella recently initiated its EMMPOWER Phase 2 clinical trial. This global 24-week, randomized, double-blind, placebo-controlled trial is evaluating the efficacy and safety of AXA1665 in approximately 150 patients who have experienced at least one prior OHE event and have neurocognitive dysfunction at screening.
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Presented Orally at DDW 2021: Data from Axcella’s AXA1665-002 clinical study were highlighted in an oral presentation at the Digestive Disease Week (DDW) 2021 Annual Meeting by Dr.
Arun Sanyal , Professor in theVirginia Commonwealth University (VCU) Department of Internal Medicine and Education Core Director in theVCU Center for Clinical and Translational Research .
AXA1125 for the Treatment of NASH
-
Initiated EMMPACT Clinical Trial: In April, the
U.S. Food and Drug Administration (FDA) cleared an Investigational New Drug (IND) application for AXA1125. Shortly thereafter, Axcella initiated its EMMPACT Phase 2b clinical trial. This global 48-week, randomized, double-blind, placebo-controlled trial is evaluating the efficacy and safety of AXA1125 in approximately 270 patients with biopsy-confirmed F2/F3 NASH. - Published Findings in Nature’s Scientific Reports: Nature’s Scientific Reports published findings from a systematic evaluation of AXA1125’s EMM constituents across multiple primary human cell model systems demonstrating that they consistently and simultaneously impacted NASH-relevant metabolic, inflammatory and fibrotic processes.
-
Presented at
ADA 81st Scientific Sessions: Clinical and nonclinical data regarding the effects from AXA1125 and its EMM constituents on insulin sensitivity were included in a poster presentation at theAmerican Diabetes Association (ADA) 81st Scientific Sessions.
Management Team
-
Added
Virginia Dean asChief People Officer : InJune 2021 , Axcella appointedVirginia Dean as the company’s Senior Vice President andChief People Officer . In this role,Ms. Dean is leading the company’s organizational and cultural development initiatives with responsibility for all human resources functions. She previously headed up ClearSight Leadership, a consulting firm specializing in HR services, and led the human resources functions for several high-growth companies, including TESARO, Inc. andARIAD Pharmaceuticals .
Financial Results
Cash Position: As of
R&D Expenses: Research and development expenses for the quarter and six months ended
G&A Expenses: General and administrative expenses for the quarter and six months ended
Net Loss: Net loss for the quarter and six months ended
Conference Call Reminder
Axcella will host a conference call today at
About Endogenous Metabolic Modulators (EMMs)
EMMs are a broad family of naturally occurring molecules, including amino acids, that regulate human metabolism. Axcella is developing a range of novel product candidates that are comprised of multiple EMMs engineered in distinct combinations and ratios to simultaneously impact multiple metabolic pathways to modify the underlying causes of various complex diseases and improve health.
About Axcella’s Clinical Development
Each of the clinical investigations that the company has completed to date have been conducted as non-investigational new drug application (IND) “clinical studies” under
Internet Posting of Information
Axcella uses its website, www.axcellahealth.com, as a means of disclosing material nonpublic information and for complying with its disclosure obligations under Regulation FD. Such disclosures will be included on the company’s website in the “Investors and News” section. Accordingly, investors should monitor this portion of the company’s website, in addition to following its press releases,
About Axcella
Axcella is a clinical-stage biotechnology company pioneering a new approach to treat complex diseases and improve health using endogenous metabolic modulator (EMM) compositions. The company’s product candidates are comprised of EMMs and their derivatives that are engineered in distinct combinations and ratios to simultaneously impact multiple biological pathways. Axcella’s pipeline includes lead therapeutic candidates for non-alcoholic steatohepatitis (NASH) and the reduction in risk of overt hepatic encephalopathy (OHE) recurrence. For more information, please visit www.axcellahealth.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 characteristics, competitive position and development potential of AXA1665, AXA1125 and potential future EMM compositions, the company’s ability to enroll its EMMPOWER and EMMPACT clinical trials in a timely manner, its ability to expand the company’s pipeline, and the company’s expected cash runway. The words “may,” “will,” “could,” “would,” “should,” “expect,” “plan,” “anticipate,” “intend,” “believe,” “estimate,” “predict,” “project,” “potential,” “continue,” “target” and similar expressions are intended to identify forward-looking statements, although not all forward-looking statements contain these 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 may cause actual events or results to differ materially from those expressed or implied by any forward-looking 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 in a timely manner or at all due to patient or principal investigator recruitment or availability challenges, clinical trial site shutdowns or other interruptions and potential limitations on the quality, completeness and interpretability of data the company is able to collect in its clinical trials of AXA1665 and AXA1125, other potential impacts of COVID-19 on the company’s business and financial results, including with respect to its ability to raise additional capital and operational disruptions or delays, changes in law, regulations, or interpretations and enforcement of regulatory guidance, whether data readouts support the company’s clinical trial plans and timing, clinical trial design and target indications for AXA1665 and AXA1125, the clinical development and safety profile of AXA1665 and AXA1125 and their therapeutic potential, whether and when, if at all, the company’s product candidates will receive approval from the FDA or other comparable regulatory authorities, potential competition from other biopharma companies in the company’s target indications, and other risks identified in the company’s
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Unaudited Condensed Consolidated Balance Sheets |
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(in thousands) |
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|
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2021 |
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2020 |
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Assets: |
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|
|
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||||
Cash and cash equivalents |
|
$ |
33,940 |
|
|
$ |
71,590 |
|
Marketable securities |
|
45,003 |
|
|
35,739 |
|
||
Other assets |
|
2,541 |
|
|
2,263 |
|
||
Total assets |
|
$ |
81,484 |
|
|
$ |
109,592 |
|
Liabilities and stockholders' equity: |
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|
|
|
||||
Liabilities |
|
$ |
33,397 |
|
|
$ |
34,211 |
|
Stockholders' equity |
|
48,087 |
|
|
75,381 |
|
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Total liabilities and stockholders' equity |
|
$ |
81,484 |
|
|
$ |
109,592 |
|
|
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Unaudited Condensed Consolidated Statements of Operations |
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(in thousands, except share and per share data) |
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Three Months Ended
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Six Months Ended
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2021 |
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2020 |
|
2021 |
|
2020 |
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Operating expenses: |
|
|
|
|
|
|
|
|||||||||
Research and development |
$ |
10,298 |
|
|
$ |
8,565 |
|
|
$ |
20,538 |
|
|
$ |
18,900 |
|
|
General and administrative |
4,946 |
|
|
4,619 |
|
|
9,202 |
|
|
8,744 |
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Total operating expenses |
15,244 |
|
|
13,184 |
|
|
29,740 |
|
|
27,644 |
|
|||||
Loss from operations |
(15,244 |
) |
|
(13,184 |
) |
|
(29,740 |
) |
|
(27,644 |
) |
|||||
Other income (expense): |
|
|
|
|
|
|
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Interest income (expense) and other income (expense), net |
(691 |
) |
|
(708 |
) |
|
(1,384 |
) |
|
(1,257 |
) |
|||||
Total other income (expense), net |
(691 |
) |
|
(708 |
) |
|
(1,384 |
) |
|
(1,257 |
) |
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Net loss |
$ |
(15,935 |
) |
|
$ |
(13,892 |
) |
|
$ |
(31,124 |
) |
|
$ |
(28,901 |
) |
|
Net loss per share, basic and diluted |
$ |
(0.42 |
) |
|
$ |
(0.48 |
) |
|
$ |
(0.83 |
) |
|
$ |
(1.10 |
) |
|
Weighted average common shares outstanding, basic and diluted |
37,732,196 |
|
|
29,202,367 |
|
|
37,692,398 |
|
|
26,195,591 |
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View source version on businesswire.com: https://www.businesswire.com/news/home/20210729005112/en/
jfredette@axcellahealth.com
(857) 320-2236
Source: Axcella