axcella press release

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12-weeks compared to the change from baseline in the placebo group (placebo These results were supported by statistically significant improvements in other non-invasive measures of liver fibrosis: ELF and FIB-4. [[Image Removed]] Any forward - looking statements in Fibroscan MRI - PDFF W24: Fibroscan MRI - PDFF W12: Fibroscan MRI - PDFF will be required to adequately address broad patient population State of the in the placebo, low dose and high dose arms, respectively (p= 0.0992 and 0.0096 FIB - 4 Score (Week 24) ELF Score (Week 24) 0.4 - 0.3 ** - 0.3 *** -1.00 -0.50 All rights reserved. In addition to effects on hepatic fat and alanine capital and operational disruptions or delays, changes in law, regulations, or trial arms. Platform and Discovery, Axcella Dr. Stephen Harrison Medical Director for These increases are the result of the Companys EMMPACT and Long COVID Phase 2 clinical trials, as well as closure costs for its EMMPOWER Phase 2 clinical trial. Daou et al. The Follow. With Nonalcoholic Steatohepatitis: A Systematic Review and Meta - Analysis. cause act ual events or results to differ materially from those expressed or On September 29, 2022, Axcella Health Inc. (the "Company" or "Axcella") issued a press release announcing interim data from its Phase 2b clinical trial of AXA1125 for the treatment of. [[Image Removed]] status Preplanned IA on secondary endpoints - Improvement in non - invasive trial arms. (67.8 g/d) (n=~90) Core elements Description Design - Randomized, double - targeted therapies in complex diseases Endogenous Metabolic Modulators (EMMs) 2021:116;2399 - 2409. 0.00 FFA FGF19 Insulin/glucose Insulin companies in the Company's target indications, and other risks identified in the "This has been an extremely exciting period for Axcella," said Bill Hinshaw President and Chief Executive Officer of Axcella. For more information, please visit www.axcellatx.com. 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. Business Wire. high doses, respectively). Soliciting material pursuant to Rule 14a-12 under the Exchange Act (17 CFR inflammation Safety and tolerability are paramount as agent will likely be used agonist FXR agonist GLP - 1RA ACC inhibitor FASN inhibitor - NASH is (7.547) 20.026 (7.541) Mean HOMA - IR 13.561 (10.977) 12.455 (10.097) 12.244 Axcella Therapeutics AXLA, a clinical-stage biotechnology company pioneering a new approach to treat complex diseases using multi-targeted endogenous metabolic modulator (EMM) compositions, today announced financial results for the third quarter ended September 30, 2022 and provided a business update. Acetyl - CoA M2 Labeling (%) *** * Acetyl - CoA M2 BHB M2 *: p<0.05 **: p<0.01 "Through the third quarter, we made important progress in our clinical development of AXA1125 and strengthened our balance sheet with a new financing. NASDAQ: AXLA AXA1125 - 101 markers at week 16 0.13 - 2.01 - 4.07 ** -6 -5 -4 -3 -2 -1 0 1 2 mean (SE) After five years of service, David Epstein stepped off the Board, and will continue to support the Company as a consultant. PREVALENCE OF NAFLD AROUND THE WORLD Younossi Z, et al. actual events or results to differ materially from those expressed or implied by 12 BID=twice a day; AE=adverse MRI - PDFF ALT=alanine aminotransferase; BID=twice a day; D=day; IA=interim versus placebo; p values derived using mixed models approach. results in the first half of 2024. discontinued due to AEs Assessed (N=960) Excluded (n=837) Completed (N =19) The information that we post on our website could be deemed to be material information. (September 13, 2022). (C) 2022 Axcella Therapeutics. an important role in addressing the challenges posed by the condition, and these words "may," "will," "coul d," "would," "should," "expect," "plan," Copyright 2022 MarketWatch, Inc. All rights reserved. shutdowns or other interruptions and potential limitations on the quality, Endogenous Metabolic Modulators. Company's product candidates will receive approval from the FDA or other AXA1125 Upregulates Fat Oxidation Genes and Pathway to Increase Consumption of subject received on day 1 of dosing. PREVALENCE OF NASH AMONG US MIDDLE - AGED COHORTS 2 prospective NASH prevalence (7.885) 18.300 (7.547) 20.026 (7.541) Mean HOMA - IR 13.561 (10.977) 12.455 Any forward-looking statements contained in this press release represent the companys views only as of the date hereof and should not be relied upon as representing its views as of any subsequent date. AXA1125: A Differentiated Product with a Potential Frontline Profile Multi - 30, 2021-- 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, . clinical trials in a timely manner or at all due to patient or principal we encourage investors, the media and others interested to review the Private Securities Litigation Reform Act of 1995, as amended, including, without Rinella ME. The words "may," "will," "could," "would," "should," "expect," "plan," Axcella Therapeutics, a clinical-stage biotechnology company pioneering a new approach to treat complex diseases using multi-targeted endogenous metabolic modulator compositions, today reported . (C) 2022 Axcella Therapeutics. Mean changes in total, physical and mental scores in the CFQ-11 versus placebo were -4.30 (p=0.0039), -2.94 (p=0.0097) and -1.32 (p=0.0097), respectively. diabetes mellitus (T2DM). . 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. Obeticholic Acid Demonstrates Per maggiori informazioni su come utilizziamo i tuoi dati, consulta la nostra Informativa sulla privacy e la nostra Informativa sui cookie. ** - 0.3 *** -1.00 -0.50 0.00 0.50 1.00 Change from baseline (SE) p < 0.0001 p= ranging study over 48 weeks Study population - Biopsy - proven F2/F3 NASH with Axcella Therapeutics (Nasdaq: AXLA), a clinical-stage biotechnology company pioneering a new approach to treat complex diseases using multi-targeted endogenous metabolic modulator (EMM) compositions, today announced that management will participate . Provide Further Evidence of Effect on Fibrosis Statistically significant changes Russell et al. ability to conduct and complete its ongoing or planned clinical studies and ), FAASLD position and development potential of AXA1125 and potential fu ture EMM The information in this Item 7.01 and Exhibits 99.1 and 99.2 attached hereto SAE, serious adverse ev ent ; TEAEs, treatment emergent adverse events Safety AXA1125 and their therapeutic potential, whether and when, if at all, the improvements compared to placebo in biomarkers for metabolism, inflammation and Stine JG, Munaganuru . All rights reserved. Please come visit members of the Axcella team at Booth #444. . to complexity of disease, single targeted mechanisms have limitations - statements contain these identifying words. NASH is a Complex Disease with Pleiotropic Disease Non - (U/L) (SD) 58.6 (34.3) 51.5 (24.2) 54.1 (36.3) Fibrosis Mean Fibroscan score These results were supported by statistically significant improvements in other non-invasive measures of liver fibrosis: ELF and FIB-4. 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 companys clinical trial data readouts, its expected cash runway and the expected benefits of Mr. Rosiellos and Mr. Straight Nissens service on the Board of Directors of Axcella. Research and development expenses for the same periods ended September 30, 2021 were $10.1 million and $30.7 million, respectively. SUMMARY The current study is enrolling patients with significant NASH and All rights reserved. events or results to differ materially from those expressed or implied by any Dati relativi al dispositivo e alla connessione a Internet, come l'indirizzo IP, Attivit di navigazione e di ricerca durante l'utilizzo dei siti web e delle app di Yahoo. Cash Position: As of September 30, 2022, cash, cash equivalents, and marketable securities totaled $25.4 million, compared to $55.0 million as of December 31, 2021. subject to a number of risks, uncertainties and important factors that may cause Williams CD, et al. FibroScan, a non-invasive measure of liver fibrosis, Subjects with NASH experienced clinically and statistically significant These completeness and interpretability of data the company is able to collect in its 45 minutes ago. disease; NASH, non - alcoholic steatohepatitis. impacts of COVID - 19 or other events on our business and financial results, VISITING PROFESSOR OF HEPATOLOGY RADCLIFFE DEPARTMENT OF MEDICINE, UNIVERSITY OF All rights reserved. 2022 Benzinga.com. Female (%) 27 (69.2) 32 (76.2) 23 (54.8) Mean Body Mass Index (kg/m 2 ) / (SD) controlled transient elastography (FibroScan), a widely accepted and accessible Bioenergetics 14.8 16.38 18.41 0 5 10 15 20 FFA LIVRQNac (10X) LIVRQNac (30X) with >1 - stage ?brosis improvement had the greatest improvement in NITs, while expressly set forth by specific reference in such filing. 3. 2022 events, conditions or circumstances on which any such statements may be based, the treatment of NASH. All rights reserved. diabetes mellitus (T2DM). Research Reports. in Nonalcoholic Steatohepatitis (NASH)." Securities and Exchange Commission filings, press releases, and public conference calls and webcasts. On September 29, 2022, Axcella Health Inc. (the "Company" or "Axcella") issued a adjusted difference of -18.98% (p=0.0082) and -21.24% (p=0.0014) for the low and Lanifibranor - Tropifexor - Obeticholic acid - EMMs - Combinations - AXA1125 - Net Loss: Net loss for the quarter and nine months ended September 30, 2022 was $17.8 million, or $0.34 per basic and diluted share, and $58.2 million, or $1.19 per basic and diluted share, respectively. leading safety and tolerability profile, and its oral dosing, these findings (EMMs). All rights reserved. Shift substrate/redox balance to restore homeostasis - Potential therapeutic Long COVID is a persistent and growing challenge of the pandemic, affecting an estimated one hundred million patients worldwide, with fatigue as the most common symptom. "anticipate," "intend," "believe," "estimate," "predict," "project," (C) 2022 Axcella Therapeutics. endpoints - Improvement in non - invasive markers, including MRI - PDFF, ALT and NFkB Gut NAS?4 - Stratification by type 2 diabetes status Preplanned IA on secondary IN LATE DEVELOPMENT 1 Yale,C. All rights reserved. The company's unique model allows for the evaluation of its EMM compositions through non-IND clinical studies or IND clinical trials. News Release Details Axcella Announces Initiation of EMMPOWER Phase 2 Clinical Trial of AXA1665. The company explicitly disclaims any obligation to update any forward-looking statements. Exhibits 99.1 and 99.2, respectively, to this Current Report on Form 8-K and are DRG. ***p<0.001, versus placebo; p values derived using mixed models approach. CAMBRIDGE, Mass.-(BUSINESS WIRE)-Sep. 12, 2022- Axcella Therapeutics (Nasdaq: AXLA), a clinical-stage biotechnology company pioneering a new approach to treat complex diseases using multi-targeted endogenous metabolic modulator (EMM) compositions, today announced that management will participate in a fireside . In September 2022, the Company received $6.0 million from the issuance of convertible notes to funds associated with Flagship Pioneering. "We find the results from this 12- and 24-week interim analysis to be extremely 2021 Nov. MRI - PDFF Monitoring Response to Therapeutic The quarter saw progress in the clinical development of AXA1125, an orally delivered potent and safe compound addressing two very large markets: Long-COVID and NASH. Act of 1933, as amended. with > 1 - stage ?brosis worsening typically showed no NIT improvement. that are engineered in distinct combinations and ratios to restore cellular Sema + cilo + firsocostat - Tropifexor + cenicriviroc - Aldafermin - Semaglutide (N=39) AXA1125 22.6 BID (N=42) AXA1125 33.9 BID (N=42) Mean age in years (SD) Contact the source provider Comtex at editorial@comtex.com. MIDDLE - AGED COHORT, N=664), [[Image Removed]] ? Clinical Trial Design & Results 20 min 8:10 am - 8:30 am Margaret Koziel All rights reserved. This press release shall not constitute an offer to sell or the solicitation of an offer to buy the Shares, nor shall there be any sale of the Shares in any state or . principal investigator recruitment or availability challenges, clinical trial OLE = Open Label Extension 0.13 - 0.7 1.06 1.09 - 2.01 - 2.6 0.76 - 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, the potential for AXA1125 to serve as a first-line treatment option. All subjects experienced significantly greater changes from baseline in MRI-PDFF at 12-weeks compared to the change from baseline in the placebo group (placebo adjusted difference of -18.98% (p=0.0082) and -21.24% (p=0.0014) for the low and high doses, respectively). Karim Azer, PhD VP of Platform and Discovery, [[Image Removed]] pathophysiology - Redundant biochemical pathways implicated in disease are not 29 Decreases in Collagen 2021 Dec 1;116(12):2399 - 2409. doi : 10.14309/ajg.0000000000001375. Grade 2 15 (38.5) 14 (33.3) 15 (35.7) Grade 3 1 (2.6) 1 (2.4) 4 (9.5) Grade 4 0 EVIDENCE FROM REGENERATE TRIAL 18 - MONTH INTERIM ANALYSIS - OBETICHOLIC ACID OXFORD MEDICAL DIRECTOR, PINNACLE CLINICAL RESEARCH PRESIDENT, SUMMIT CLINICAL L, I, V, R, Q, Nac added at specified - fold concentrations above plasma (ex: * - 21.2 ** -30 -20 -10 0 10 20 mean (SE), % *p<0.05, **p<0.01, ***p<0.001, press release announcing interim data from its Phase 2b clinical trial of change in liver stiffness at 24-weeks at both dose levels suggests that AXA1125 (C) 2022 Axcella Therapeutics. barrier/ tight junction, [[Image Removed]] development Axcella AXA1125 Ph2b (F2/F3) 24wks Completers Akero 1 Efruxifermin markers, including MRI - PDFF, ALT and Fibroscan, [[Image Removed]] Presentation. 57 Closing Remarks Bill Absolute changes in LSM were 0.13, -2.01, and -4.07 kilopascals (kPa) in the placebo, low dose and high dose arms, respectively (p= 0.0992 and 0.0096 for the low and high dose, respectively, compared to placebo). [[Image Removed]] SE, standard error DMC, independent data Axcella's multi-targeted approach is well-suited to playing implied by any forward - looking statements contained in this presentation, (C) 2022 Axcella Therapeutics. [[Image Removed]] (September 13, 2022). ", Dr. Margret Koziel, Chief Medical Officer of Axcella remarked that "The positive Hepatology 2018;68:9A - 10A. Get the latest Pittsburgh local news, breaking news, sports, entertainment, weather and traffic, as well as national and international news, from the Pulitzer Prize-winning staff of the Pittsburgh Post-Gazette. All rights reserved. 2021. Axcella uses the "Investors and News" section of its website, . [[Image Removed]] [[Image Removed]] - Sept. 29, 2022 - Axcella Therapeutics (Nasdaq: AXLA), a identify forward-looking statements, although not all forward-looking statements Consistent with 25 All studies conducted with *** *** Fibrosis Donor 1 Donor 2 Donor 3, [[Image Removed]] NASH Market Complexity of NASH Need for Options 30% - 40% Type 2 Diabetic (T2DM) Axcella Therapeutics (Nasdaq: AXLA), a clinical-stage biotechnology company pioneering a new approach to treat complex diseases using multi-targeted endogenous metabolic modulator (EMM) compositions, today announced financial results for the third quarter ended September 30, 2022 and provided a business update. 0.05 0.10 0.15 0.20 0.25 0.30 0.35 0.40 0-9 10-19 20-44 45-64 65+ NAFLD of the markets for the company's product candidates, the company's intellectual 33.9 BID AXA1125 22.6 BID P >0.1, [[Image Removed]] (C) 2022 Axcella Therapeutics. BID=twice a day; LSM=liver stiff nes s measurement; kPa=kilo pascals; 119% Increase in < 10 years, [[Image Removed]] 1.9 - 15.3 * - 19.0 ** -25 -20 -15 -10 -5 0 5 Relative change, mean (SE), % Axcella Therapeutics (Nasdaq: AXLA), a clinical-stage biotechnology company pioneering a new approach to treat complex diseases using multi-targeted endogenous metabolic modulator (EMM) compositions, today announced that it will present data on clinical plasma proteomic biomarkers in patients with NASH at the American Association for the Study of Liver Diseases (AASLD) Annual Meeting being . (kPa) (SD) 13.29 (6.72) 11.40 (3.47) 14.80 (6.63) Mean Fib - 4 (SD) 1.48 (0.65) Placebo AXA1125 33.9 BID AXA1125 22.6 BID. [[Image Removed]] Timing AXA1125 for NASH Phase 2b Interim Data Q3 2022 x First Adolescent Subject (C) 2022 Axcella Therapeutics. with both doses and in both populations - Potential for differentiation in key deposition ER Stress UPR JNK ROS Hepatic stellate cell activation Kupffer cell Lipogenesis FFA Collagen Earnings Axcella Health beat estimated earnings by 10.53%, reporting an EPS of $-0.34 versus an estimate of $-0.38. forward-looking statements contained in this Form 8-K, including, without following provisions ( see General Instruction A.2. Health. 21 Safety based on what CAMBRIDGE, Mass., (BUSINESS WIRE) -- Axcella Therapeutics (Nasdaq: AXLA), a clinical-stage biotechnology company . The company cautions placebo or 22.6g or 33.9g of AXA1125 twice daily. Simultaneous with the financing, the company appointed Robert Rosiello and Torben Straight Nissen to its Board of Directors, and Mr. Rosiello also became Chairman of the Board. Cliccando su Accetta tutto accetti che Yahoo e i suoi partner possano trattare i tuoi dati personali e utilizzare tecnologie come i cookie per mostrarti annunci e contenuti personalizzati, per la misurazione degli annunci e dei contenuti, per l'analisi del pubblico e per lo sviluppo dei prodotti. effects of AXA1125 administration on selected outcome measures after 12 and 24 156,1 (2019): 88 - 95.e5. Results Dr. Margaret Koziel Chief Medical Officer, [[Image Removed]] BHB M2 (nmol) **** ****, [[Image Removed]] events, conditions, or circumstances on which any such statements may be based, Cusi K. Diabetologia . information that we post there on a regular basis. without limitation, those related to the potential impact of COVID-19 on the were supported by statistically significant improvements in other NITs of liver The information that we . only weak association - NIT improvements observed in REGENERATE are associated cycle Metabolism Fatty acid degradation (29/43) ( fdr : 2.1e - 06) 0 1 2 3 4 56.2 (12.4) Sex Male, n (%) 12 (30.8) 10 (23.8) 19 (45.2) Female, n (%) 27 30 Key MOA Takeaways - NASH is completeness and interpretability of data we are able to collect in our clinical - risk - t121855 Conclusion - NASH is a large complex disease with a high unmet Rinella ME. combination, [[Image Removed]] 1 for 24 hours, EdU data normalized to at: European Association for the Study of the Liver; 27 - 29 August 2020; PATIENT DEMOGRAPHICS AND BASELINE METRICS Baseline Demographic/Metric Placebo -10 -5 0 5 Rel ghg .,, mean (SE), % 9.6 - 12.6 - 21.2 ** -30 -20 -10 0 10 20 (C) 2022 Axcella Therapeutics. TRIAL 18 - MONTH INTERIM ANALYSIS - OBETICHOLIC ACID N=931 - Patients with >1 - cause this year - U.S. market expected to reach at least $8 billion by 2027 3 - representative of future results and other risks identi fie d in our SEC Check the appropriate box below if the Form 8-K filing is intended to global Phase 2b randomized, double-blind, placebo-controlled, dose ranging 13 Patient Demographics and harness the power of EMMs to tackle complex chronic conditions - Improving In this interim analysis, at 24-weeks there were statistically significant improvements in the liver stiffness measurement (LSM) using vibration-controlled transient elastography compared to placebo in the high dose arm for all subjects. operational disruptions or delays, changes in law, regulations, or AXA1125, the clinical development and safety profile of our product candidates (C) 2022 Axcella Therapeutics. dysregulations in distinct cellular targets - Pre - clinical data demonstrates 0. . ET; To register, click here. you not to place undue reliance on any forward-looking statements, which speak included vibration controlled transient elastography (FibroScan), a widely 19 or other events on our ability to conduct and complete ongoing or planned target indications for AXA1125, the clinical development and safety profile of palmitate:oleate and 1 ng/ml TNF - ? patients with > 1 - stage ?brosis worsening typically showed no NIT improvement. For more improvement in NASH on serial liver biopsy. You can also contact MarketWatch Customer Service via our Customer Center. All rights reserved. (C) 2022 Axcella Therapeutics. have been correlated with improvements in liver fibrosis and outcomes in limitation, those related to the potential impact of COVID-19 on the Company's These decreases are primarily the result of lower non-cash stock-based compensation expenses. Loomba R., et al. Financial Results: Cash Position: As of September 30, 2022, cash, cash equivalents, and marketable securities totaled $25.4 million, compared to $55.0 million as of December 31, 2021. then stimulated with 3.3ng/ml TGF - ? diseases using multi-targeted endogenous metabolic modulator (EMM) compositions, Inflammation Mean ALT (U/L) (SD) 58.6 (34.3) 51.5 (24.2) 54.1 (36.3) Fibrosis EASL Axcella is a clinical-stage biotechnology company pioneering a new approach to treat complex diseases using compositions of endogenous metabolic modulators (EMMs). Axcella Therapeutics AXLA, a clinical-stage biotechnology company pioneering a new approach to treat complex diseases using multi-targeted endogenous metabolic modulator (EMM) compositions, today . The. and should not be relied upon as representing its views as of any subsequent oc Analysis From the Interim Analysis of the REGENERATE Study. - 201 Long COVID Fatigue 4 wk (N=41) Planned Registrational Trial Long COVID 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 readouts, its expected cash runway and the expected benefits of mr. rosiello's and mr. straight nissen's blind, placebo - controlled, dose - ranging study over 48 weeks Study population in PDFF were seen at week 24 but these were not statistically significant in the without limitation, statements regarding the characteristics, competitive subjects experienced significantly greater changes from baseline in MRI-PDFF at SUBJECTS/ARM REACHED WEEK 12 D1: Biopsy Fibroscan MRI - PDFF W48: Biopsy 9 MoA = mechanism of action. ACOX1 HADHB ACAT1 ADH4 ADH6 GCDH ACAA1 ADH1C CYP4A11 CYP4A22 ADH1B ACADL EHHADH 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. Benzinga does not provide investment advice. Gastroenterol Hepatol. - AUROC values for each of these were suggestive of ALT Monitoring Response to Therapeutic Interventions EVIDENCE FROM FLINT 72 - Endogenous Metabolic Modulator (EMM) compositions to treat complex medical Analysis - 7 studies / 346 patients "These results support the use of MRI - PDFF Gastroenterology . arr@lifesciadvisors.com disease state with significant fibrosis, [[Image Removed]] Copyright 2022 MarketWatch, Inc. All rights reserved. Deposition Measured with AXA1125 Reduced Fibrogenic Activation & Proliferation Act (17 CFR 240.13e-4(c)). (EDGAR Online via COMTEX) -- position AXA1125 as an attractive candidate for first line treatment of NASH. Harrison SA, et al. Daou et al. site shutdowns or other interruptions and potential limitations on the quality, With 8,000 attendees The Liver Meeting is the world's premier meeting on liver disease. G&A Expenses: General and administrative expenses for the quarter and nine months ended September 30, 2022 were $3.8 million and $12.3 million, respectively. Axcella Therapeutics (Nasdaq: AXLA), a clinical-stage biotechnology company pioneering a new approach to treat complex diseases using multi-targeted endogenous metabolic modulator (EMM) compositions, today announced financial results for the third quarter ended September 30, 2022 and provided a business update. Mitochondrial, Lipid and Energy Pathways Driving Reduced Liver Fat and Proliferation, Deposition Donor 1 Donor 2 Donor 3 *** *** *** *** HSP47 *** *** shall not be deemed "filed" for purposes of Section 18 of the Securities and Akero Phase 2B HARMONY Trial Data Glycerolipid metabolism 3x Acetyl - CoA Removal 2x Acetyl - CoA Removal Citrate - 4.07 ** -6 -4 -2 0 2 Abs, chg. mean (SE) 1.9 - 15.3 ** - 19.0 ** -25 -20 -15 1 - SCD1 - FGF21 - THR - ? Extended cash runway by ~$5M (December 2019) by devising and implementing a time sensitive ATM (at the market .

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