AXLA Axcella Health Inc.

3.4
-0.2  -6%
Previous Close 3.6
Open 3.53
52 Week Low 3.03
52 Week High 6.84
Market Cap $123,919,365
Shares 36,446,872
Float 10,895,805
Enterprise Value $2,200,099
Volume 152,340
Av. Daily Volume 385,677
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Drug Pipeline

Drug Stage Notes
AXA1665 (EMMPOWER)
Hepatic encephalopathy
Phase 2
Phase 2
Phase 2 trial initiation announced June 30, 2021.
AXA1125 (EMMPACT)
Non-alcoholic steatohepatitis (NASH) / non-alcoholic fatty liver disease (NAFLD)
Phase 2b
Phase 2b
Phase 2b initiation announced May 11, 2021.

Latest News

    • 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
    • Enhanced management team with the addition of Chief People Officer
    • Company to host conference call at 8:30 a.m. ET today

    Axcella (NASDAQ:AXLA), a clinical-stage biotechnology company pioneering a new approach to treat complex diseases and improve health using endogenous metabolic modulator (EMM) compositions, today announced financial results for the second quarter ended June 30, 2021 and provided a business update.

    "Thanks to solid execution on the part of our team, Axcella has rapidly advanced the development of its…

    • 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
    • Enhanced management team with the addition of Chief People Officer
    • Company to host conference call at 8:30 a.m. ET today

    Axcella (NASDAQ:AXLA), a clinical-stage biotechnology company pioneering a new approach to treat complex diseases and improve health using endogenous metabolic modulator (EMM) compositions, today announced financial results for the second quarter ended June 30, 2021 and provided a business update.

    "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 Bill Hinshaw, President and Chief Executive Officer of Axcella. "Our progress continued in the second quarter as we initiated the EMMPOWER Phase 2 clinical trial of AXA1665 in overt hepatic encephalopathy (OHE) as well as the EMMPACT Phase 2b clinical trial of AXA1125 in nonalcoholic steatohepatitis (NASH). With a high level of interest and engagement from the medical community and many clinical sites already activated for each of these global trials, I am pleased to report that we are off to a strong start. As we enter the second half of 2021, maximizing clinical trial enrollment and expanding Axcella's pipeline are our primary areas of focus."

    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.
    • 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 the Virginia Commonwealth University (VCU) Department of Internal Medicine and Education Core Director in the VCU 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 the American Diabetes Association (ADA) 81st Scientific Sessions.

    Management Team

    • Added Virginia Dean as Chief People Officer: In June 2021, Axcella appointed Virginia Dean as the company's Senior Vice President and Chief 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. and ARIAD Pharmaceuticals.

    Financial Results

    Cash Position: As of June 30, 2021, cash, cash equivalents, and marketable securities totaled $78.9 million, compared to $107.3 million at December 31, 2020. Axcella continues to expect that its existing cash balance will be sufficient to meet the company's operating needs into the third quarter of 2022.

    R&D Expenses: Research and development expenses for the quarter and six months ended June 30, 2021 were $10.3 million and $20.5 million, respectively. Research and development expenses for the same periods ended June 30, 2020 were $8.6 million and $18.9 million. These increases are primarily the result of work related to the initiations of the company's EMMPOWER and EMMPACT clinical trials.

    G&A Expenses: General and administrative expenses for the quarter and six months ended June 30, 2021 were $4.9 million and $9.2 million, respectively. General and administrative expenses for the same periods ended June 30, 2020 were $4.6 million and $8.7 million. These increases are primarily the result of greater non-cash stock-based compensation expenses and benefit-related costs.

    Net Loss: Net loss for the quarter and six months ended June 30, 2021 was $15.9 million, or $0.42 per basic and diluted share, and $31.1 million, or $0.83 per basic and diluted share, respectively. This compares with a net loss of $13.9 million, or $0.48 per basic and diluted share, and $28.9 million, or $1.10 per basic and diluted share, for the quarter and six months ended June 30, 2020.

    Conference Call Reminder

    Axcella will host a conference call today at 8:30 a.m. ET to discuss the company's financial results and other recent business updates. The conference call webcast will be accessible in the Investors & News section on the company's website at www.axcellahealth.com. To access the call via telephone, please dial (844) 808-7139 (U.S. toll free) or (412) 902-0127 (international) five minutes prior to the start time. For those unable to listen in live, a webcast archive will be available on the company's website for 90 days following the call.

    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 U.S. Food and Drug Administration regulations and guidance supporting research with food. These studies evaluate product candidates for safety, tolerability and effects on the normal structures and functions in humans, including in individuals with disease. They are not designed or intended to evaluate a product candidate's ability to diagnose, cure, mitigate, treat or prevent a disease. If and when Axcella decides to develop a product candidate as a potential therapeutic, as is the case with AXA1665 and AXA1125, the company will seek an IND to enable the initiation of "clinical trials."

    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, SEC filings and public conference calls and webcasts.

    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 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 any forward-looking statements, which speak only as of the date they are made. Axcella disclaims any obligation to publicly update or revise any such statements to reflect any change in expectations or in events, conditions or circumstances on which any such statements may be based, or that may affect the likelihood that actual results will differ from those set forth 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 relied upon as representing its views as of any subsequent date. The company explicitly disclaims any obligation to update any forward-looking statements.

    Axcella Health Inc.

    Unaudited Condensed Consolidated Balance Sheets

    (in thousands)

     

     

     

     

     

     

     

    June 30,

     

    December 31,

     

     

    2021

     

    2020

    Assets:

     

     

     

     

    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:

     

     

     

     

    Liabilities

     

    $

    33,397

     

     

    $

    34,211

     

    Stockholders' equity

     

    48,087

     

     

    75,381

     

    Total liabilities and stockholders' equity

     

    $

    81,484

     

     

    $

    109,592

     

    Axcella Health Inc.

    Unaudited Condensed Consolidated Statements of Operations

    (in thousands, except share and per share data)

     

     

     

     

     

    Three Months Ended

    June 30,

     

    Six Months Ended

    June 30,

     

    2021

     

    2020

     

    2021

     

    2020

    Operating expenses:

     

     

     

     

     

     

     

    Research and development

    $

    10,298

     

     

    $

    8,565

     

     

    $

    20,538

     

     

    $

    18,900

     

    General and administrative

    4,946

     

     

    4,619

     

     

    9,202

     

     

    8,744

     

    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):

     

     

     

     

     

     

     

    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

    )

    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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  1. Conference call to take place at 8:30 a.m. ET

    Axcella (NASDAQ:AXLA), a clinical-stage biotechnology company pioneering a new approach to treat complex diseases and improve health using endogenous metabolic modulator (EMM) compositions, today announced that it plans to report its second quarter 2021 financial results and other business updates on July 29, 2021. The company will host a conference call at 8:30 a.m. ET that morning.

    The conference call webcast will be available in the Investors & News section on the company's website at www.axcellahealth.com. To access the call via telephone, please dial (844) 808-7139 (U.S. toll free) or (412) 902-0127 (international) five minutes prior to the start time. For those unable to listen in live…

    Conference call to take place at 8:30 a.m. ET

    Axcella (NASDAQ:AXLA), a clinical-stage biotechnology company pioneering a new approach to treat complex diseases and improve health using endogenous metabolic modulator (EMM) compositions, today announced that it plans to report its second quarter 2021 financial results and other business updates on July 29, 2021. The company will host a conference call at 8:30 a.m. ET that morning.

    The conference call webcast will be available in the Investors & News section on the company's website at www.axcellahealth.com. To access the call via telephone, please dial (844) 808-7139 (U.S. toll free) or (412) 902-0127 (international) five minutes prior to the start time. For those unable to listen in live, a webcast archive will be available on the company's website for 90 days following the call.

    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, SEC filings and public conference calls and webcasts.

    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.

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    • Initial clinical sites activated and patient screening underway
    • Potential to improve the standard of care for cirrhotic patients by addressing multiple key drivers of overt hepatic encephalopathy (OHE)

    Axcella (NASDAQ:AXLA), a clinical-stage biotechnology company pioneering a new approach to treat complex diseases and improve health using endogenous metabolic modulator (EMM) compositions, today announced that it has activated initial clinical sites and patient screening for its global Phase 2 clinical trial of AXA1665, the company's multi-targeted oral product candidate for the reduction in risk of recurrent overt hepatic encephalopathy (OHE).

    "OHE is a condition that has devastating consequences for patients and families and places a…

    • Initial clinical sites activated and patient screening underway
    • Potential to improve the standard of care for cirrhotic patients by addressing multiple key drivers of overt hepatic encephalopathy (OHE)

    Axcella (NASDAQ:AXLA), a clinical-stage biotechnology company pioneering a new approach to treat complex diseases and improve health using endogenous metabolic modulator (EMM) compositions, today announced that it has activated initial clinical sites and patient screening for its global Phase 2 clinical trial of AXA1665, the company's multi-targeted oral product candidate for the reduction in risk of recurrent overt hepatic encephalopathy (OHE).

    "OHE is a condition that has devastating consequences for patients and families and places a substantial economic burden on the overall healthcare system," said Andres Duarte-Rojo, M.D., M.S., Ph.D., Department of Medicine, Division of Gastroenterology, Hepatology and Nutrition at the University of Pittsburgh and the trial's principal investigator. "Given the limitations of today's standards of care and the lack of clinical development activity beyond ammonia-focused agents, it also is an area in dire need of medical innovation. In prior clinical studies, AXA1665 has demonstrated the potential to have a multifactorial benefit to patients inclusive of improvements in amino acid balancing, ammonia metabolism, muscle function and neurocognition. I look forward to investigating AXA1665's ability to replicate these findings and reduce OHE events in EMMPOWER."

    Axcella has branded the Phase 2 trial EMMPOWER based on the potential for AXA1665, an EMM composition, to help patients, physicians and other caregivers overcome significant challenges associated with cirrhosis and OHE. This randomized, double-blind, placebo-controlled, multi-center investigation will evaluate the efficacy and safety of AXA1665 in patients who have experienced at least one prior OHE event and have neurocognitive dysfunction at screening. Approximately 150 patients on lactulose ± rifaximin (stratified by rifaximin use) will be randomized 1:1 to receive either 53.8 grams per day of AXA1665 or a calorie-matched placebo in three divided doses for 24 weeks, with a four-week safety follow-up period.

    "The initiation of EMMPOWER is an important milestone, ushering in an exciting new era of clinical development for Axcella as we seek to tackle a variety of complex diseases utilizing proprietary, multi-targeted EMM compositions," said Bill Hinshaw, President and Chief Executive Officer of Axcella.

    The EMMPOWER trial will be conducted globally at more than 70 clinical sites with a primary endpoint assessing the proportion of patients with a ≥2 point increase in the psychometric hepatic encephalopathy score (PHES) after the 24-week treatment period. The trial's key secondary endpoints will focus on the proportion of patients experiencing an OHE breakthrough event and time to first OHE breakthrough event, including time to hospitalization. Other secondary endpoints include changes in physical function, including the liver frailty index, and patient-reported outcomes. Measures of circulating ammonia, amino acid profile, and inflammation-related markers will also be included as endpoints.

    "By taking on the core drivers of OHE more comprehensively, we not only see the potential for AXA1665 to improve today's standard of care, but also to eventually become a first-line treatment option," said Alison Schecter, M.D., President of R&D at Axcella. "On behalf of the Axcella organization, we would like to express our gratitude to the many patients and dozens of clinical global sites that will be involved in this trial as we seek to transform the OHE treatment paradigm."

    Additional trial information can be found on https://clinicaltrials.gov/ via the identifier NCT04816916.

    About AXA1665 and Overt Hepatic Encephalopathy (OHE)

    Hepatic encephalopathy (HE), one of the most common complications of cirrhosis, is a condition involving amino acid imbalance, ammonia toxicity and muscle wasting, all of which contribute to diminished brain function. OHE refers to the presence of neurological abnormalities that are clinically apparent and do not require specialized psychometric testing. OHE is well established as a significant cause of morbidity and mortality in the cirrhotic population and is an area that continues to have unmet medical needs.

    AXA1665, Axcella's product candidate for reduction in risk of recurrent OHE, is a composition of eight amino acids and derivatives that is designed to target multiple metabolic pathways intersecting key organ systems, including the liver, muscle and gut. In prior clinical studies, this oral product candidate has been safe, well tolerated and has demonstrated the potential to improve ammonia handling, physical function, amino acid balance and neurocognition with a safe and well tolerated profile. AXA1665 is now in Phase 2 development.

    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 Studies

    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 U.S. Food and Drug Administration regulations and guidance supporting research with food. These studies evaluate product candidates for safety, tolerability and effects on the normal structures and functions in humans, including in individuals with disease. They are not designed or intended to evaluate a product candidate's ability to diagnose, cure, mitigate, treat or prevent a disease. If Axcella decides to further develop a product candidate as a potential therapeutic, as is the case with AXA1665 and AXA1125, any subsequent clinical studies will be conducted under an IND.

    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, SEC filings and public conference calls and webcasts.

    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, the potential for AXA1665 to improve upon the standard of care for OHE patients and reduce OHE events, and the company's ability to address other complex diseases utilizing EMM compositions. 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 IND-enabled 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 planned clinical trial of AXA1665, other potential impacts of COVID-19 on the company's our business and financial results, including with respect to the company's 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 initiation plans and timing, clinical trial design and target indications for AXA1665, the clinical development and safety profile of AXA1665 and its 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 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 any forward-looking statements, which speak only as of the date they are made. Axcella disclaims any obligation to publicly update or revise any such statements to reflect any change in expectations or in events, conditions or circumstances on which any such statements may be based, or that may affect the likelihood that actual results will differ from those set forth 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 relied upon as representing its views as of any subsequent date. The company explicitly disclaims any obligation to update any forward-looking statements.

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  2. New Board Members Will Help Advance ‘Gene Writing' Platform and Mission to Cure Disease by Writing in the Code of Life

    Tessera Therapeutics, a biotech company pioneering Gene Writing, announced today the appointment of Elliott Sigal, M.D., Ph.D. and Mary Rozenman, Ph.D. to the company's Board of Directors. This announcement represents the latest key development for Tessera, following the March appointments of David Davidson, M.D. as Chief Medical and Development Officer, Hari Pujar, Ph.D. as Chief Operating Officer, and Lin Guey, Ph.D. as Senior Vice President of Rare Diseases Program Strategy and Operations, and a $230 million Series B fundraising round in January.

    "Elliott and Mary bring phenomenal leadership, experience, and creativity…

    New Board Members Will Help Advance ‘Gene Writing' Platform and Mission to Cure Disease by Writing in the Code of Life

    Tessera Therapeutics, a biotech company pioneering Gene Writing, announced today the appointment of Elliott Sigal, M.D., Ph.D. and Mary Rozenman, Ph.D. to the company's Board of Directors. This announcement represents the latest key development for Tessera, following the March appointments of David Davidson, M.D. as Chief Medical and Development Officer, Hari Pujar, Ph.D. as Chief Operating Officer, and Lin Guey, Ph.D. as Senior Vice President of Rare Diseases Program Strategy and Operations, and a $230 million Series B fundraising round in January.

    "Elliott and Mary bring phenomenal leadership, experience, and creativity to Tessera's Board of Directors," said Geoffrey von Maltzahn, Ph.D., CEO and Co-Founder of Tessera. "Elliott has overseen more than a dozen new medications on their way to market, and Mary has guided major strategic, fundraising, and partnership efforts. Together, they offer decades of experience that will help us rapidly grow Tessera and to fulfill our mission of curing diseases by writing in the code of life."

    "The next frontier in medicine will be therapeutics that cure and provide enduring protection against disease. I am excited to welcome Elliott and Mary to the team at Tessera and look forward to working closely with them as we advance Tessera's Gene Writing platform and pioneer the future of genetic medicine," said Noubar Afeyan, Ph.D., Co-founder and Chairman of the Board, Tessera and CEO of Flagship Pioneering.

    Dr. Sigal brings decades of clinical experience in drug discovery, drug development, and corporate strategy to Tessera's Board of Directors. He currently serves as a senior advisor to the healthcare team of New Enterprise Associates and is a member of the Board of Directors for Adaptimmune Therapeutics, Surface Oncology, Vir Therapeutics, and Affinia. He co-chairs the Scientific Advisory Board for Amgen and is a member of the Scientific Steering Committee for the Sean Parker Institute for Cancer Immunology. He previously served on the Board of Directors for the gene therapy company, Spark Therapeutics. Dr. Sigal is a former Executive Vice President and Director of Bristol-Myers Squibb, and served as the company's Chief Scientific Officer and President of R&D from 2004 until 2013. Under his leadership, fourteen new medicines came to market in multiple therapeutic areas including virology, oncology, immunology, psychiatry, metabolic diseases and cardiovascular disease. During his tenure, Dr. Sigal was named the best R&D chief in the pharmaceutical industry by Scrip Intelligence. Dr. Sigal received his M.D. from the University of Chicago and trained in Internal Medicine and Pulmonary Medicine at UCSF. Prior to medical school, he received his B.S., M.S., and Ph.D. in Industrial Engineering from Purdue University.

    "Tessera's Gene Writing technology represents a major breakthrough in the field with potential to fundamentally change the future of medicine across many therapeutic areas," said Dr. Elliott Sigal. "I am honored to join the Board and look forward to helping guide the company through continued growth and innovation."

    Dr. Rozenman brings more than 15 years of scientific expertise, company building, and transactions leadership in the biotech industry to Tessera's Board of Directors. She serves as the CFO and CBO of insitro, leading strategic and operational finance and accounting strategy, business development, investor relations, corporate communications, as well as project and portfolio management. Prior to insitro, Dr. Rozenman served as the Senior Vice President of Corporate Development and Strategy at Aimmune Therapeutics, where she oversaw business development and partnerships with companies including Regeneron/Sanofi and Nestle Health Science and supported the company's strategic finance and investor relations efforts. Across her time at both insitro and Aimmune, Dr. Rozenman has raised more than $1 billion in capital through a range of public and private transactions, including leadership of Aimmune's IPO in 2015. She received her Ph.D. in Organic Chemistry and Chemical Biology from Harvard University and her B.A. in Biochemistry and Russian Literature from Columbia University.

    "Tessera is pioneering Gene Writing at a pivotal moment for drug discovery, as we rapidly expand our understanding of the genetic drivers of disease. Tessera's work to write into the genome may open opportunities to cure and prevent a broad range of diseases. I am thrilled to join the Board during such an exciting time in the company's growth and look forward to partnering with Geoff and the world class Tessera team," said Dr. Mary Rozenman.

    For more information on Tessera, including how Gene Writing works, partnership opportunities, and job openings, visit www.tesseratherapeutics.com.

    About Tessera Therapeutics

    Tessera Therapeutics is an early-stage life sciences company pioneering Gene Writing, a new biotechnology designed to offer scientists and clinicians the ability to write small and large therapeutic messages into the genome, thereby curing diseases at their source. Gene Writing holds the potential to become a new category in genetic medicine, building upon recent breakthroughs in gene therapy and gene editing while eliminating important limitations in their reach, utilization, and efficacy. Tessera Therapeutics was founded by Flagship Pioneering, a life sciences innovation enterprise that conceives, resources, and develops first-in-category companies to transform human health and sustainability.

    About Flagship Pioneering

    Flagship Pioneering conceives, creates, resources, and develops first-in-category life science platform companies to transform human health and sustainability. Since its launch in 2000, the firm has, through its Flagship Labs unit, applied its unique hypothesis-driven innovation process to originate and foster more than 100 scientific ventures, resulting in over $90 billion in aggregate value. To date, Flagship has deployed over $2.4 billion in capital toward the founding and growth of its pioneering companies alongside more than $19 billion of follow-on investments from other institutions. The current Flagship ecosystem comprises 41 transformative companies, including Axcella Health (NASDAQ:AXLA), Codiak BioSciences (NASDAQ:CDAK) Denali Therapeutics (NASDAQ:DNLI), Evelo Biosciences (NASDAQ:EVLO), Foghorn Therapeutics (NASDAQ:FHTX), Indigo Ag, Kaleido Biosciences (NASDAQ:KLDO), Moderna (NASDAQ:MRNA), Rubius Therapeutics (NASDAQ:RUBY), Sana Biotechnology (NASDAQ:SANA), Seres Therapeutics (NASDAQ:MCRB), and Sigilon Therapeutics (NASDAQ:SGTX).

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  3. CAMBRIDGE, Mass., June 14, 2021 /PRNewswire/ -- Flagship Pioneering, the bioplatform innovation company, today announced a significant expansion of its capital base to support founding and growing its next generation of human health and sustainability companies. Flagship re-opened Fund VII in April 2021 to current Limited Partners and a select group of new investors, raising an additional $2.23 billion for a total capital pool of $3.37 billion. This brings together for the first time its origination and growth strategies under one investment vehicle with a long-term focus on the creation, development, and growth of its first-in-category bioplatform companies.

    CAMBRIDGE, Mass., June 14, 2021 /PRNewswire/ -- Flagship Pioneering, the bioplatform innovation company, today announced a significant expansion of its capital base to support founding and growing its next generation of human health and sustainability companies. Flagship re-opened Fund VII in April 2021 to current Limited Partners and a select group of new investors, raising an additional $2.23 billion for a total capital pool of $3.37 billion. This brings together for the first time its origination and growth strategies under one investment vehicle with a long-term focus on the creation, development, and growth of its first-in-category bioplatform companies.

    "At Flagship Pioneering, we are re-imagining how to prevent and treat disease, feed a growing population, and sustain our planet. We do this by harnessing chemistry, biology, and machine learning/AI to build cohesive, integrated platforms, each with the potential for multiple transformative products," said Noubar Afeyan, Ph.D., Founder and Chief Executive Officer of Flagship Pioneering. "There is no better example of the power of bioplatform companies than Flagship-founded Moderna, which was able to rapidly shift its focus in 2020 to develop, test, and deploy its COVID-19 vaccine in record time."

    Dr. Afeyan continued, "In the last year alone, breakthroughs at Rubius Therapeutics, Denali Therapeutics, Seres Therapeutics, and others demonstrated the exponential impact bioplatforms can have on health. Biotechnology is at the leading edge of technological progress, challenging us to think beyond incremental advances and take big leaps – and Flagship Pioneering is focused on actively leaping to the scientific spaces ripe for disruption."

    Financial Update

    After Fund VII's close, Flagship is now operating with an aggregate capital pool of $6.7 billion, with $14.1 billion assets under management. Over the past four quarters, Flagship deployed $370 million in capital to its companies, combined with more than $4.4 billion from other capital providers, for a total of $4.8 billion in new capital fueling Flagship companies.

    "We are grateful to our longstanding Limited Partners and our new investors for their support as we pioneer life science solutions to tackle the world's most urgent issues," said Stephen Berenson, Managing Partner, Flagship Pioneering. "This expanded capital pool will enable us to support first-in-category platform companies, spanning human therapeutics, agriculture, and nutrition, as well as our soon-to-be-launched Preemptive Medicine and Health Security Initiative, and the development of a robust pipeline of clinical assets through our Pioneering Medicines Division."

    Driving Ground-breaking Multi-Product Bioplatforms                                      

    Flagship Pioneering is dedicated to exploring and innovating in uncharted spaces, as well as founding, launching, and advancing new companies to develop and commercialize these innovations.

    "The biological century is an era of new possibility. Today, the opportunity to harness biology for the benefit of humanity and the world is unprecedented," said Doug Cole, M.D., Managing Partner, Flagship Pioneering. "At Flagship, we challenge ourselves daily to discover what is not yet visible, invent what has previously not been possible, and imagine and realize new ways to treat, cure, diagnose, and prevent diseases."

    Flagship's team of entrepreneurial scientists, executives, and operations experts, as well as its companies, achieved important milestones in the last year, as follows:

    • Unveiled Generate Biomedicines, Invaio Sciences, Inzen Therapeutics, Laronde, and Valo Health
    • Raised $1.8 billion in private investments for early growth-stage companies: Cellarity, Inari Agriculture, Indigo Ag, Invaio Sciences, Omega Therapeutics, Repertoire Immune Medicines, Ring Therapeutics, Senda Biosciences, Tessera Therapeutics, and Valo Health
    • Completed Initial Public Offerings at Codiak Biosciences (NASDAQ:CDAK), Foghorn Therapeutics (NASDAQ:FHTX), Sana Biotechnology (NASDAQ:SANA), and Sigilon Therapeutics (NASDAQ:SGTX)
    • Raised follow-on public market capital in Axcella (NASDAQ:AXLA), Codiak Biosciences (NASDAQ:CDAK), Evelo (NASDAQ:EVLO), Kaleido (NASDAQ:KLDO), Moderna (NASDAQ:MRNA), Rubius (NASDAQ:RUBY), and Seres (NASDAQ:MCRB)
    • Conducted more than 60 new explorations, the first step of our company origination process
    • Filed more than 300 patent applications from Flagship Labs
    • Flagship ecosystem companies have 53 clinical programs and 150 pre-clinical programs currently underway

    Assembling a World-Class Team

    Flagship is committed to bringing on the highest caliber industry executives with track records of exceptional performance, as evidenced in the company's new hires over the past year. These have included the recent additions of Christopher P. Austin, M.D., as CEO-Partner, Ara Darzi, M.D., as Chair, Preemptive Medicine and Health Security Initiative, Michael T. Nally, as CEO-Partner and CEO of Generate Biomedicines, and Louisa Salter-Cid, Ph.D., as Chief Scientific Officer for Pioneering Medicines. In addition, Flagship has hired a number of world class executives, scientists, and operations leaders to roles across the company and its ecosystem of companies. 

    Introducing Preemptive Medicine and Health Security, a New, More Comprehensive Approach to Health Security

    Flagship is actively building a division tasked with pioneering a new field that aims to protect, maintain, or improve people's health before they get sick by proactively intervening in those who are seemingly healthy but at risk. It will encompass interventions that protect health from external threats (health security) as well as to prevent or delay the onset of disease (preemptive health) to better prepare for the next infectious disease threats, and to pursue bolder treatments for existing pandemic diseases such as obesity, cancer, and neurodegeneration. Learn more about Flagship's perspective in this recent whitepaper, "Health Security and Beyond: A New Paradigm for a Post-Pandemic World."

    "The pandemic has laid bare the critical nature of health, not only to individuals, but to economies and societies," said Ara Darzi, M.D., Chair of Flagship's Preemptive Medicine and Health Security Initiative. "Flagship is pioneering a new field that aims to protect, maintain, and improve people's health by providing security against threats for everyone, and preventing or postponing the onset of disease for 'seemingly healthy' people, before they experience any recognisable symptoms at all."

    Building the Pioneering Medicines Division

    Flagship launched its Pioneering Medicines Division earlier this year to harness the power of Flagship's scientific and development innovation to create and advance novel therapeutic medicines that benefit more patients sooner. Given the broad applicability of many Flagship platforms, Pioneering Medicines is focused on expanding the reach of these scientific innovations by creating medicines in disease areas where the companies are not yet focused and working across platforms in unprecedented ways.

    "Pioneering Medicines is focused on innovative approaches to achieving greater impact for patients at faster speeds," said Paul Biondi, Executive Partner, Flagship Pioneering and President of Pioneering Medicines. "We are leveraging the innovative scientific platforms and technologies within Flagship Pioneering's ecosystem of companies to conceive and develop a unique portfolio of life-changing treatments for patients."

    About Flagship Pioneering

    Flagship Pioneering conceives, creates, resources, and develops first-in-category bioplatform companies to transform human health and sustainability. Since its launch in 2000, the firm has, through its Flagship Labs unit, applied its unique hypothesis-driven innovation process to originate and foster more than 100 scientific ventures, resulting in over $90 billion in aggregate value. To date, Flagship has deployed over $2.4 billion in capital toward the founding and growth of its pioneering companies alongside more than $19 billion of follow-on investments from other institutions. The current Flagship ecosystem comprises 41 transformative companies, including Denali Therapeutics (NASDAQ:DNLI), Indigo Ag, Moderna (NASDAQ:MRNA), Rubius Therapeutics (NASDAQ:RUBY), Sana Biotechnology (NASDAQ:SANA), Seres Therapeutics (NASDAQ:MCRB), and Valo Health.

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    SOURCE Flagship Pioneering

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