UNITED STATES
SECURITIES AND EXCHANGE COMMISSION
Washington, D.C. 20549
FORM 8-K
CURRENT REPORT
Pursuant to Section 13 or 15(d)
of the Securities Exchange Act of 1934
Date of Report (Date of earliest event reported): September 14, 2020
89bio, Inc.
(Exact name of registrant as specified in its charter)
| Delaware | 001-39122 | 36-4946844 | ||
| (State or other jurisdiction of incorporation) |
(Commission File Number) |
(IRS Employer Identification No.) |
142 Sansome Street, Second Floor
San Francisco, CA 94104
(Address of principal executive offices, including zip code)
(415) 500-4614
(Registrant’s telephone number, including area code)
Not Applicable
(Former name or former address, if changed since last report)
Check the appropriate box below if the Form 8-K filing is intended to simultaneously satisfy the filing obligation of the registrant under any of the following provisions:
| ☐ | Written communications pursuant to Rule 425 under the Securities Act (17 CFR 230.425) |
| ☐ | Soliciting material pursuant to Rule 14a-12 under the Exchange Act (17 CFR 240.14a-12) |
| ☐ | Pre-commencement communications pursuant to Rule 14d-2(b) under the Exchange Act (17 CFR 240.14d-2(b)) |
| ☐ | Pre-commencement communications pursuant to Rule 13e-4(c) under the Exchange Act (17 CFR 240.13e-4(c)) |
Securities registered pursuant to Section 12(b) of the Act:
| Title of each class |
Trading Symbol(s) |
Name of each exchange on which registered | ||
| Common Stock, par value $0.001 per share | ETNB | The Nasdaq Global Market |
Indicate by check mark whether the registrant is an emerging growth company as defined in Rule 405 of the Securities Act of 1933 (§230.405 of this chapter) or Rule 12b-2 of the Securities Exchange Act of 1934 (§240.12b-2 of this chapter).
Emerging growth company ☒
If an emerging growth company, indicate by check mark if the registrant has elected not to use the extended transition period for complying with any new or revised financial accounting standards provided pursuant to Section 13(a) of the Exchange Act. ☐
| Item 7.01 | Regulation FD Disclosure. |
On September 14, 2020, 89bio, Inc. (the “Company”) issued a press release titled “89bio Announces Positive Topline Results from its Phase 1b/2a Trial of BIO89-100 in NASH.” A copy of the press release is attached as Exhibit 99.1 to this Current Report on Form 8-K.
In accordance with General Instruction B.2 of Form 8-K, the information in this Item 7.01, including Exhibits 99.1 and 99.2, shall not be deemed to be “filed” for purposes of Section 18 of the Exchange Act or otherwise subject to the liabilities of that section, and shall not be incorporated by reference into any registration statement or other document filed under the Securities Act or the Exchange Act, except as shall be expressly set forth in such registration statement or filing.
| Item 8.01 | Other Events. |
The Company from time to time presents and/or distributes to the investment community slide presentations to provide updates and summaries of its business. A copy of the BIO89-100 Phase 1b/2a Topline Results slide presentation is being furnished herewith as Exhibit 99.2 to this Current Report on Form 8-K. The Company undertakes no obligation to update, supplement or amend the materials attached hereto as Exhibit 99.2.
| Item 9.01 | Financial Statements and Exhibits |
(d) Exhibits.
EXHIBIT INDEX
| Exhibit No. |
Description | |
| 99.1 | Press Release, dated September 14, 2020 | |
| 99.2 | Slide Presentation, dated September 14, 2020 | |
SIGNATURES
Pursuant to the requirements of the Securities Exchange Act of 1934, the registrant has duly caused this report to be signed on its behalf by the undersigned hereunto duly authorized.
| 89bio, Inc. | ||||||
| Date: September 14, 2020 | By: | /s/ Rohan Palekar | ||||
| Rohan Palekar | ||||||
| Chief Executive Officer | ||||||
Exhibit 99.1
89bio Announces Positive Topline Results from its Phase 1b/2a Trial of BIO89-100 in NASH
All dose groups achieved statistically significant reductions in liver fat, with relative reductions of up to 60% versus baseline and up to 70% versus placebo
Favorable safety and tolerability profile
Strong efficacy profile with every two-week dosing
Statistically significant improvements in markers of liver injury and key lipid parameters
Conference call and webcast scheduled for 8:30 am ET (5:30 am PT) today
SAN FRANCISCO, Sept. 14, 2020 — 89bio, Inc. (Nasdaq: ETNB) today announced positive topline results from its Phase 1b/2a trial with BIO89-100, an investigational FGF21 analog, in patients with nonalcoholic steatohepatitis (NASH). All dose groups demonstrated significant reductions in liver fat at week 13, with relative reductions up to 60% versus baseline and up to 70% versus placebo, as measured by magnetic resonance imaging – proton density fat factor (MRI-PDFF). A significant proportion of subjects responded to therapy with up to 88% and 71% of subjects achieving a ³30% or a ³50% reduction in liver fat versus baseline, respectively. Treatment with BIO89-100 also resulted in significant improvements in liver transaminases, with a 35 U/L decrease in ALT from baseline in subjects with elevated baseline levels, and reductions in ProC3, a marker of fibrosis. Importantly, BIO89-100 is the first FGF21 analog to show benefit in subjects with NASH with every two-week dosing. BIO89-100 was well tolerated at all doses with low incidence of adverse events that occurred in ³10% of subjects and very low frequency of gastrointestinal (GI) events relative to placebo.
The MRI-PDFF results are summarized in the table below:
| BIO89-100 (once-weekly) |
BIO89-100 (once every two weeks) |
|||||||||||||||||||||||||||
| Measure |
Placebo (n= 19) |
3mg (n= 6) |
9mg (n= 12) |
18mg (n= 11) |
27mg (n= 10) |
18 mg (n= 14) |
36 mg (n= 9) |
|||||||||||||||||||||
| Relative reduction/increase in liver fat vs. baseline |
+10 | % | -37 | %** | -50 | %** | -36 | %** | -60 | %** | -43 | %** | -50 | %** | ||||||||||||||
| Relative reduction in liver fat vs. placebo |
-47 | %** | -59 | %** | -46 | %** | -70 | %** | -53 | %** | -60 | %** | ||||||||||||||||
| Proportion of subjects with ³30% relative reduction in liver fat |
0 | % | 60 | %* | 82 | %** | 60 | %** | 86 | %** | 69 | %** | 88 | %** | ||||||||||||||
| Absolute change in liver fat vs. baseline |
+1.4 | -7.5 | %* | -10 | %** | -7.5 | %** | -13.5 | %** | -9.0 | %** | -9.7 | %** | |||||||||||||||
*p<0.01; **p<0.001 vs. placebo. n based on subjects randomized. Least square mean based on MRI analysis set (N=75) and responder analysis based on subjects with MRI at Week 13. Levels of liver fat in the BIO89-100 and placebo groups at baseline were 21.2% (on a pooled basis) and 21.8%, respectively. Baseline liver fat levels and changes in liver fat were similar in biopsy-confirmed NASH and phenotypical NASH subjects.
“The robust reductions in liver fat and key liver markers add to a growing body of evidence demonstrating the promise of BIO89-100 for the treatment of NASH and cardio-metabolic diseases,” said Rohit Loomba, MD, MHSc, Director of the UC San Diego NAFLD Research Center and Director of
Hepatology at UC San Diego School of Medicine. “The magnitude of ³30% relative reduction in liver fat has been shown in the literature to translate into higher odds of histologic response and potential to deliver clinically meaningful benefit to patients with NASH.”
BIO89-100 had a favorable safety and tolerability profile with no deaths or serious adverse events related to treatment. The frequency of GI events compared favorably to placebo with diarrhea (BIO89-100 12.7% vs. placebo 22.2%) and nausea (BIO89-100 7.9% vs. placebo 16.7%) being the only GI events occurring in ³5% of BIO89-100-treated subjects. The only treatment-related adverse event that occurred in ³10% of all BIO89-100-treated subjects was mild, increased appetite (15.9%) consistent with other investigational FGF21 analogs. No adverse effects on heart rate or blood pressure were observed.
Treatment with BIO89-100 resulted in significant reductions in triglycerides (up to 28%; p <0.05), non-HDL (up to 16%; p<0.01) and LDL-C (up to 16%; p<0.05). Triglycerides were reduced to a greater extent in subjects with elevated triglycerides at baseline (TG³200 mg/mL), and 53% of the BIO89-100 subjects in this group normalized triglyceride levels versus 0% in the placebo group. BIO89-100 also demonstrated significant increases in the insulin-sensitizing hormone adiponectin (up to 61%; p<0.001).
This study was a randomized, double-blind, placebo-controlled, multiple ascending dose-ranging trial that enrolled 81 biopsy-proven NASH or phenotypical NASH (PNASH) subjects. A total of 81 subjects were randomized to receive weekly or every two-week dosing of BIO89-100 or placebo for up to 12 weeks. Key endpoints assessed were safety, tolerability, and PK of BIO89-100 as well as change in liver fat measured by MRI-PDFF and other metabolic markers.
“The favorable safety and tolerability profile of BIO89-100 together with potential best-in-class dosing regimen could be important considerations for a NASH therapeutic given the chronic and generally asymptomatic nature of the disease,” said Hank Mansbach, MD, Chief Medical Officer, 89bio. “These factors, combined with improvements in liver fat and metabolic markers, unequivocally support advancing the clinical development of BIO89-100 in NASH and reinforce our confidence in the severe hypertriglyceridemia program. We plan to initiate our next trial in NASH in the first half of 2021.”
“We are pleased with this data that highlight BIO89-100’s promising clinical profile and its potential to be a leading FGF21 analog, in a class with the potential to become a backbone treatment approach for NASH,” said Rohan Palekar, Chief Executive Officer, 89bio. “I would like to sincerely thank all of our investigators, clinical sites, subjects, and employees who supported the trial, especially amid a pandemic that has severely impacted the global healthcare system in an unprecedented manner.”
Conference Call/Webcast Details
89bio will host a conference call and webcast with slides at 8:30am PT (5:30am PT) this morning, September 14. Details for the live conference call are as follows: Domestic – (833) 570-1145; International – (914) 987-7092; and Passcode - 5064866. To access the live webcast and slides, please visit “Events and Presentations” under the “Investors” section of 89bio’s website at https://ir.89bio.com/events-and-presentations. Following the live audio webcast, a replay will be available on the company’s website for 90 days.
About NASH
NASH is the most advanced stage of nonalcoholic fatty liver disease (NAFLD). It is a complex metabolic disorder that causes fat buildup in the liver, as well as inflammation and eventually fibrosis, and it can worsen to cirrhosis and liver failure. NASH affects more than 16 million adults in the United States, and
by 2030 its prevalence is predicted to increase by 63 percent. The exact cause of NASH is unknown, but it is commonly found in people with obesity and type 2 diabetes. While there are currently no approved treatments, the biopharmaceutical industry is actively involved in addressing this unmet medical need.
About the Phase 1b/2a Study
This clinical study was a multicenter, randomized, double-blind, placebo-controlled, multiple ascending dose-ranging trial. It was designed to assess the safety, tolerability, and PK properties of BIO89-100 as well as change in liver fat measured by MRI-PDFF and key biomarker assessments in subjects with biopsy-proven NASH with fibrosis or patients with phenotypical NASH (PNASH). PNASH was defined as patients with steatosis greater than 10% who have central obesity and Type 2 diabetes or central obesity and evidence of liver injury. Both populations that were enrolled had similar disease characteristics at baseline. A total of 81 subjects were randomized to receive weekly or every two weeks subcutaneous dosing of BIO89-100 or placebo for up to 12 weeks.
About BIO89-100
BIO89-100 is a glycoPEGylated analog of FGF21 being developed for the treatment of NASH. 89bio has optimally engineered BIO89-100 using a proprietary glycoPEGylation technology to balance efficacy and longer dosing interval. Recent Phase 1b/2a data show BIO89-100 demonstrated a favorable safety and tolerability profile and robust reductions in liver fat and key lipid markers when dosed weekly or once every two weeks. BIO89-100 is also being developed for the treatment of severe hypertriglyceridemia (SHTG) and is currently in a Phase 2 trial.
About 89bio
89bio is a clinical-stage biopharmaceutical company focused on the development and commercialization of innovative therapies for the treatment of liver and cardio-metabolic diseases. The company’s lead product candidate is BIO89-100, is a specifically engineered glycoPEGylated analog of FGF21. BIO89-100 is being developed for the treatment of NASH and severe hypertriglyceridemia (SHTG). 89bio is headquartered in San Francisco with operations in Herzliya, Israel. For more information, visit www.89bio.com.
Forward-looking Statements
Certain statements in this press release may constitute “forward-looking statements” within the meaning of the federal securities laws, including, but not limited to, 89bio’s expectations and guidance regarding its business plans and objectives for BIO89-100, including the therapeutic potential and clinical benefits thereof, as well as the safety and tolerability of BIO89-100 and future clinical development plans; 89bio’s statements regarding the Phase 1b/2a Trial of BIO89-100; and the potential impact of COVID-19 on patient retention, strategy, future operations and clinical trials, including the anticipated timing of the next trial in NASH. Words such as “may,” “might,” “will,” “objective,” “intend,” “should,” “could,” “can,” “would,” “expect,” “believe,” “design,” “estimate,” “predict,” “potential,” “develop,” “plan” or the negative of these terms, and similar expressions, or statements regarding intent, belief, or current expectations, are forward looking statements. While 89bio believes these forward-looking statements are reasonable, undue reliance should not be placed on any such forward-looking statements, which are based on information available to us on the date of this release. These forward-looking statements are based upon current estimates and assumptions and are subject to various risks and uncertainties (including, without limitation, those set forth in 89bio’s filings with the SEC), many of which are beyond 89bio’s control and subject to change. Actual results could be materially different.
Risks and uncertainties include: expectations regarding the timing and outcome of 89bio’s initiation of the next trial in NASH; 89bio’s ability to execute on its strategy; positive results from a clinical study may not necessarily be predictive of the results of future or ongoing clinical studies; regulatory developments in the United States; the effect of the COVID-19 pandemic on 89bio’s clinical trials and business operations, and the impact of general economic, health, industrial or political conditions in the United States or internationally; and other risks and uncertainties identified in 89bio’s Annual Report on Form 10-K for the year ended December 31, 2019 and its Quarterly Report on Form 10-Q for the quarter ended June 30, 2020 and other subsequent disclosure documents filed with the SEC. 89bio claims the protection of the Safe Harbor contained in the Private Securities Litigation Reform Act of 1995 for forward-looking statements. 89bio expressly disclaims any obligation to update or alter any statements whether as a result of new information, future events or otherwise, except as required by law.
Investor Contact:
Ryan Martins
Chief Financial Officer
investors@89bio.com
Media Contact:
Lori Rosen
LDR Communications
917-553-6808
lori@ldrcommunications.com
Exhibit 99.2 Powerful Science Meaningful Medicines Changing Lives BIO89-100 Phase 1b/2a Topline Results Nasdaq: ETNB September 14, 2020Exhibit 99.2 Powerful Science Meaningful Medicines Changing Lives BIO89-100 Phase 1b/2a Topline Results Nasdaq: ETNB September 14, 2020
Disclaimer CautionaryNoteRegardingForward-LookingStatements This presentation contains“forward-lookingstatements” within the meaning of the federal securities laws, which statements are subject to substantial risks and uncertainties and are based on estimates and assumptions. Other than statements of historical facts, all statements included in this presentation are forward-looking statements, including statements concerning our plans, objectives, goals, strategies, future events, future revenues or performance, financing needs, plans or intentions relating to product candidates, estimates of market size, business trends, the anticipated timing, costs, design and conduct of our planned clinicaltrials forBIO89-100, ouronly product candidate, the association of preclinical datawith potentialclinicalbenefit, the timing ofanticipated milestones, theeffectoftheCOVID-19pandemiconour clinicaltrialsandbusinessoperations,thetimingandlikelihood ofregulatoryfilingsand approvalsforBIO89-100,our abilitytocommercializeBIO89-100,ifapproved,thepricingandreimbursementofBIO89-100, ifapproved, thepotentialto developfutureproductcandidates,ourabilitytoscaleupmanufacturing,thepotentialbenefitsofstrategiccollaborationsand ourintenttoenterintoanystrategicarrangements,the timing and likelihood of success, plans and objectives of management for future operations and future results of anticipated product development efforts and our liquidity and capital resources. In some cases, you can identify forward-looking statements by terms such as“may,”“might,”“will,”“objective,”“intend,”“should,”“could,”“can,”“would,”“expect,”“believe,”“design,”“estimate,”“predict,”“potential,” “plan” or the negative of these terms, and similar expressions intended to identify forward-looking statements. These statements involve known and unknown risks, uncertainties and other factors that could cause our actual results to differ materially from the forward-looking statements expressed or implied in this presentation including those described more fully our most recent Form 10-K and Form 10-Q under thecaption“RiskFactors”andelsewhere insuchreportand inother subsequentdisclosuredocumentsfiled withtheSEC. Wecannot assureyouthat we will realizethe results, benefits or developments thatwe expect or anticipate or, even ifsubstantially realized, that they will resultin the consequences or affectus or our business in the way expected. Forward-looking statements are not historical facts, and reflect our current views with respect to future events. Given the significant uncertainties, you should evaluate all forward-looking statements made in this presentation in the context of these risks and uncertainties and not place undue reliance on these forward-looking statements as predictions of future events. All forward-looking statements inthis presentationapply only as ofthe date madeand are expressly qualified intheir entirety by thecautionary statements included inthis presentation. Wedisclaimany intenttopublicly update or reviseanyforward-looking statementstoreflectsubsequentevents orcircumstances,exceptasrequired bylaw. Weobtained the industry, marketand competitive position data usedthroughoutthis presentation from our own internal estimates and research, as wellas from industry and general publications, and research, surveys and studies conducted by third parties. Internal estimates are derived from publicly available information released by industry analysts and third-party sources, our internal research and our industry experience, and are based on assumptions made by us based on such data and our knowledge of the industry and market, which we believe to be reasonable. In addition, while we believe the industry, market and competitive position data included in this presentation is reliable and based on reasonable assumptions, we have not independently verified any third-party information, and all such data involve risks and uncertainties andaresubjecttochangebasedonvarious factors. 0Disclaimer CautionaryNoteRegardingForward-LookingStatements This presentation contains“forward-lookingstatements” within the meaning of the federal securities laws, which statements are subject to substantial risks and uncertainties and are based on estimates and assumptions. Other than statements of historical facts, all statements included in this presentation are forward-looking statements, including statements concerning our plans, objectives, goals, strategies, future events, future revenues or performance, financing needs, plans or intentions relating to product candidates, estimates of market size, business trends, the anticipated timing, costs, design and conduct of our planned clinicaltrials forBIO89-100, ouronly product candidate, the association of preclinical datawith potentialclinicalbenefit, the timing ofanticipated milestones, theeffectoftheCOVID-19pandemiconour clinicaltrialsandbusinessoperations,thetimingandlikelihood ofregulatoryfilingsand approvalsforBIO89-100,our abilitytocommercializeBIO89-100,ifapproved,thepricingandreimbursementofBIO89-100, ifapproved, thepotentialto developfutureproductcandidates,ourabilitytoscaleupmanufacturing,thepotentialbenefitsofstrategiccollaborationsand ourintenttoenterintoanystrategicarrangements,the timing and likelihood of success, plans and objectives of management for future operations and future results of anticipated product development efforts and our liquidity and capital resources. In some cases, you can identify forward-looking statements by terms such as“may,”“might,”“will,”“objective,”“intend,”“should,”“could,”“can,”“would,”“expect,”“believe,”“design,”“estimate,”“predict,”“potential,” “plan” or the negative of these terms, and similar expressions intended to identify forward-looking statements. These statements involve known and unknown risks, uncertainties and other factors that could cause our actual results to differ materially from the forward-looking statements expressed or implied in this presentation including those described more fully our most recent Form 10-K and Form 10-Q under thecaption“RiskFactors”andelsewhere insuchreportand inother subsequentdisclosuredocumentsfiled withtheSEC. Wecannot assureyouthat we will realizethe results, benefits or developments thatwe expect or anticipate or, even ifsubstantially realized, that they will resultin the consequences or affectus or our business in the way expected. Forward-looking statements are not historical facts, and reflect our current views with respect to future events. Given the significant uncertainties, you should evaluate all forward-looking statements made in this presentation in the context of these risks and uncertainties and not place undue reliance on these forward-looking statements as predictions of future events. All forward-looking statements inthis presentationapply only as ofthe date madeand are expressly qualified intheir entirety by thecautionary statements included inthis presentation. Wedisclaimany intenttopublicly update or reviseanyforward-looking statementstoreflectsubsequentevents orcircumstances,exceptasrequired bylaw. Weobtained the industry, marketand competitive position data usedthroughoutthis presentation from our own internal estimates and research, as wellas from industry and general publications, and research, surveys and studies conducted by third parties. Internal estimates are derived from publicly available information released by industry analysts and third-party sources, our internal research and our industry experience, and are based on assumptions made by us based on such data and our knowledge of the industry and market, which we believe to be reasonable. In addition, while we believe the industry, market and competitive position data included in this presentation is reliable and based on reasonable assumptions, we have not independently verified any third-party information, and all such data involve risks and uncertainties andaresubjecttochangebasedonvarious factors. 0
BIO89-100: Promising Benefit-Risk Profile with Convenient Dosing EFFICACY RESULTS • Significant benefits across key liver parameters observed across all dose groups – Up to 60% reduction in liver fat versus baseline and up to 70% versus placebo – Up to 44% reduction in ALT (35 U/L decrease in high ALT group) – Up to 27% reduction in Pro-C3 • Significant responder rates— Up to 88% and 71% of subjects showed fat reduction ≥30% and ≥50% • Significant improvements in lipids—triglycerides, non-HDL and LDL SAFETY RESULTS & TOLERABILITY • Well tolerated at all doses with low incidence of adverse events that occurred in ≥ 10% of subjects • Very low frequency of gastrointestinal events and similar profile to placebo • No hypersensitivity or tremor observed: no adverse effects on heart rate or blood pressure POTENTIAL BEST-IN-CLASS DOSING REGIMEN • Results seen with weekly and two-week dosing 1BIO89-100: Promising Benefit-Risk Profile with Convenient Dosing EFFICACY RESULTS • Significant benefits across key liver parameters observed across all dose groups – Up to 60% reduction in liver fat versus baseline and up to 70% versus placebo – Up to 44% reduction in ALT (35 U/L decrease in high ALT group) – Up to 27% reduction in Pro-C3 • Significant responder rates— Up to 88% and 71% of subjects showed fat reduction ≥30% and ≥50% • Significant improvements in lipids—triglycerides, non-HDL and LDL SAFETY RESULTS & TOLERABILITY • Well tolerated at all doses with low incidence of adverse events that occurred in ≥ 10% of subjects • Very low frequency of gastrointestinal events and similar profile to placebo • No hypersensitivity or tremor observed: no adverse effects on heart rate or blood pressure POTENTIAL BEST-IN-CLASS DOSING REGIMEN • Results seen with weekly and two-week dosing 1
BIO89-100 Is An FGF21 Optimally Engineered To Balance Potential for Efficacy and Long Dosing Interval C-terminus C-terminus glycoPEG(20kD) FGF21 C-terminus C-terminus Strong and flexible linker FGF21 N-terminus N-terminus (glycoPEGylation technology) β-Klotho β-Klotho β-Klotho Position 182 Ns β-Klotho FGFR FGFR FGFR FGFR N-terminus C-terminus FGF21 XX Mutations in positions 173 and 176 (glycoPEG attached at position 173) Signal transduction Signal transduction Functional response Functional response • FGF21 is an endogenous metabolic hormone that regulates energy expenditure and glucose and lipid metabolism • Proprietary glycoPEGylation technology with site-specific mutations • Long half-life of 55-100 hours vs. native FGF21 half-life of < 2 hours based on single ascending dose study • Low nanomolar potency against FGF receptors 1c, 2c, 3c, similar to native FGF21; no activity against receptor 4 (leads to increased LDL) 2BIO89-100 Is An FGF21 Optimally Engineered To Balance Potential for Efficacy and Long Dosing Interval C-terminus C-terminus glycoPEG(20kD) FGF21 C-terminus C-terminus Strong and flexible linker FGF21 N-terminus N-terminus (glycoPEGylation technology) β-Klotho β-Klotho β-Klotho Position 182 Ns β-Klotho FGFR FGFR FGFR FGFR N-terminus C-terminus FGF21 XX Mutations in positions 173 and 176 (glycoPEG attached at position 173) Signal transduction Signal transduction Functional response Functional response • FGF21 is an endogenous metabolic hormone that regulates energy expenditure and glucose and lipid metabolism • Proprietary glycoPEGylation technology with site-specific mutations • Long half-life of 55-100 hours vs. native FGF21 half-life of < 2 hours based on single ascending dose study • Low nanomolar potency against FGF receptors 1c, 2c, 3c, similar to native FGF21; no activity against receptor 4 (leads to increased LDL) 2
BIO89-100-002: Trial Design KEY INCLUSION CRITERIA (n=9) 36mg (n=3) Placebo # • NASH* or phenotypic NASH (PNASH) (n=10) 27mg (n=3) • PDFF≥10% Placebo (n=11) 18mg *Subjects with biopsy-proven F1-3 (n=4) # Placebo Central obesity plus T2DM or evidence of liver injury 18mg (n=14) (n=4) Placebo KEY TRIAL ENDPOINTS (n=12) 9mg (n=3) Placebo • Safety, PK • Relative changes in liver fat 3mg (n=6) (n=2) Placebo • Serum lipids, liver and metabolic markers Randomization QW SC Q2W SC • Randomized, pharmacodynamic (PD) and safety analysis set n=81; • 12-week treatment duration + 4-week safety follow up Study completers n=71 • Placebo (n=19) combined across cohorts for analysis • MRI analysis set n=75 (subjects with post-baseline MRI) 3BIO89-100-002: Trial Design KEY INCLUSION CRITERIA (n=9) 36mg (n=3) Placebo # • NASH* or phenotypic NASH (PNASH) (n=10) 27mg (n=3) • PDFF≥10% Placebo (n=11) 18mg *Subjects with biopsy-proven F1-3 (n=4) # Placebo Central obesity plus T2DM or evidence of liver injury 18mg (n=14) (n=4) Placebo KEY TRIAL ENDPOINTS (n=12) 9mg (n=3) Placebo • Safety, PK • Relative changes in liver fat 3mg (n=6) (n=2) Placebo • Serum lipids, liver and metabolic markers Randomization QW SC Q2W SC • Randomized, pharmacodynamic (PD) and safety analysis set n=81; • 12-week treatment duration + 4-week safety follow up Study completers n=71 • Placebo (n=19) combined across cohorts for analysis • MRI analysis set n=75 (subjects with post-baseline MRI) 3
Baseline Characteristics Pooled Parameter Placebo 3mg QW 9mg QW 18mg QW 27mg QW 18mg Q2W 36mg Q2W BIO89-100 Mean or % (n=19) (n=6) (n=12) (n=11) (n=10) (n=14) (n=9) (n=62) 52.6 51.7 56.1 49.5 51.5 52.0 51.2 52.5 Age (years) 36.8% 38.7% 16.7% 50% 27.3% 20% 28.6% 88.9% Male/Female 93.6 93.6 87.9 87.2 87.1 94.0 101.5 101.1 Weight (kg) 2 33.8 34.8 34.3 32.7 32.8 36.8 37.0 34.8 BMI (kg/m ) Type 2 Diabetes 63.2% 40.3% 83.3% 33.3% 63.6% 40.0% 21.4% 22.2% 38.8 42.3 45.0 32.8 38.4 53.3 39.1 50.4 ALT (U/L) 29.0 31.5 34.5 22.8 30.9 39.0 28.8 38.1 AST (U/L) 21.8 21.2 22.4 21.4 19.3 22.0 21.6 20.9 MRI-PDFF (%) Baseline characteristics were similar between NASH (n=15) and PNASH (n=66) subjects 4Baseline Characteristics Pooled Parameter Placebo 3mg QW 9mg QW 18mg QW 27mg QW 18mg Q2W 36mg Q2W BIO89-100 Mean or % (n=19) (n=6) (n=12) (n=11) (n=10) (n=14) (n=9) (n=62) 52.6 51.7 56.1 49.5 51.5 52.0 51.2 52.5 Age (years) 36.8% 38.7% 16.7% 50% 27.3% 20% 28.6% 88.9% Male/Female 93.6 93.6 87.9 87.2 87.1 94.0 101.5 101.1 Weight (kg) 2 33.8 34.8 34.3 32.7 32.8 36.8 37.0 34.8 BMI (kg/m ) Type 2 Diabetes 63.2% 40.3% 83.3% 33.3% 63.6% 40.0% 21.4% 22.2% 38.8 42.3 45.0 32.8 38.4 53.3 39.1 50.4 ALT (U/L) 29.0 31.5 34.5 22.8 30.9 39.0 28.8 38.1 AST (U/L) 21.8 21.2 22.4 21.4 19.3 22.0 21.6 20.9 MRI-PDFF (%) Baseline characteristics were similar between NASH (n=15) and PNASH (n=66) subjects 4
BIO89-100 Significantly Reduces Liver Fat Across All Dose Groups Absolute Change in Liver Fat (%) from Baseline at Week 13 QW Q2W Placebo 3mg 9mg 18mg 27mg 18mg 36mg 5 • Up to 43% of subjects normalized their liver fat 1.4 (<5%) 0 • BIO89-100 significantly reduced liver volume up to 15% -5 • Changes in liver fat were *** ** -7.5 -7.5 similar between NASH and -10 *** -9.0 *** PNASH subjects *** -9.7 -10.0 *** -13.5 -15 MRI Analysis Set; MMRM LS Mean; * p<0.05; ** p<0.01; *** p<0.001 versus placebo 5BIO89-100 Significantly Reduces Liver Fat Across All Dose Groups Absolute Change in Liver Fat (%) from Baseline at Week 13 QW Q2W Placebo 3mg 9mg 18mg 27mg 18mg 36mg 5 • Up to 43% of subjects normalized their liver fat 1.4 (<5%) 0 • BIO89-100 significantly reduced liver volume up to 15% -5 • Changes in liver fat were *** ** -7.5 -7.5 similar between NASH and -10 *** -9.0 *** PNASH subjects *** -9.7 -10.0 *** -13.5 -15 MRI Analysis Set; MMRM LS Mean; * p<0.05; ** p<0.01; *** p<0.001 versus placebo 5
BIO89-100 Reduces Liver Fat in Significant Percentage of Subjects Relative Reduction in Liver Fat from Baseline at Week 13 Proportion of Subjects with ≥30% QW Q2W Relative Reduction in Liver Fat Placebo 3mg 9mg 18mg 27mg 18mg 36mg 20% Placebo 0% 10% ** 3mg 60% 0% *** 9mg 82% ** 18mg 60% *** 27mg 86% -30% ** *** *** 18mg 69% -36% -37% *** -43% *** *** 36mg 88% *** -50% -50% -60% *** -60% MRI Analysis Set; MMRM LS Mean; * p<0.05; ** p<0.01; *** p<0.001 versus placebo 6 Q2W QWBIO89-100 Reduces Liver Fat in Significant Percentage of Subjects Relative Reduction in Liver Fat from Baseline at Week 13 Proportion of Subjects with ≥30% QW Q2W Relative Reduction in Liver Fat Placebo 3mg 9mg 18mg 27mg 18mg 36mg 20% Placebo 0% 10% ** 3mg 60% 0% *** 9mg 82% ** 18mg 60% *** 27mg 86% -30% ** *** *** 18mg 69% -36% -37% *** -43% *** *** 36mg 88% *** -50% -50% -60% *** -60% MRI Analysis Set; MMRM LS Mean; * p<0.05; ** p<0.01; *** p<0.001 versus placebo 6 Q2W QW
Majority of Subjects on BIO89-100 Achieved ≥50% Reduction in Liver Fat Relative Reduction in Liver Fat versus Placebo at Week 13 Proportion of Subjects with ≥50% QW Q2W Relative Reduction in Liver Fat 3mg 9mg 18mg 27mg 18mg 36mg Placebo 0% -10% 3mg 20% ** 9mg 54% -30% ** 18mg 50% *** 27mg 71% *** *** -50% -46% -47% ** 18mg 39% *** -53% *** ** *** -59% 36mg 50% -60% -70% *** -70% MRI Analysis Set; MMRM LS Mean; * p<0.05; ** p<0.01; *** p<0.001 versus placebo 7 Q2W QWMajority of Subjects on BIO89-100 Achieved ≥50% Reduction in Liver Fat Relative Reduction in Liver Fat versus Placebo at Week 13 Proportion of Subjects with ≥50% QW Q2W Relative Reduction in Liver Fat 3mg 9mg 18mg 27mg 18mg 36mg Placebo 0% -10% 3mg 20% ** 9mg 54% -30% ** 18mg 50% *** 27mg 71% *** *** -50% -46% -47% ** 18mg 39% *** -53% *** ** *** -59% 36mg 50% -60% -70% *** -70% MRI Analysis Set; MMRM LS Mean; * p<0.05; ** p<0.01; *** p<0.001 versus placebo 7 Q2W QW
BIO89-100 Showed Substantial Reduction in Liver Fat and Liver Volume After 12 Weeks of Treatment (Subject at 27mg QW) Liver fat (%) Parameter Baseline Week 13 % Change Liver fat 41.1% 5.1% -87.6% 1.4 -35.4% Liver volume (L) 2.2 8BIO89-100 Showed Substantial Reduction in Liver Fat and Liver Volume After 12 Weeks of Treatment (Subject at 27mg QW) Liver fat (%) Parameter Baseline Week 13 % Change Liver fat 41.1% 5.1% -87.6% 1.4 -35.4% Liver volume (L) 2.2 8
BIO89-100 Showed Substantial Reduction in Liver Fat and Liver Volume After 12 Weeks of Treatment (Subject at 18mg Q2W) Liver fat (%) Parameter Baseline Week 13 % Change Liver fat 16.8% 3.5% -79.2% 0.9 -27.7% Liver volume (L) 1.2 9BIO89-100 Showed Substantial Reduction in Liver Fat and Liver Volume After 12 Weeks of Treatment (Subject at 18mg Q2W) Liver fat (%) Parameter Baseline Week 13 % Change Liver fat 16.8% 3.5% -79.2% 0.9 -27.7% Liver volume (L) 1.2 9
BIO89-100 Significantly Reduces ALT Percent Change Over Time Percent Change from Baseline at Week 13 QW Q2W Baseline W7 W13 Placebo 3mg 9mg 18mg 27mg 18mg 36mg 20% -4% -10% 0% -17% * -19% -20% * * * -30% -27% -27% ** * * * *** *** -40% *** *** *** -40% Placebo 3 mg QW 9 mg QW *** 18 mg QW 27 mg QW 18 mg Q2W -44% 36 mg Q2W -60% -50% Absolute change: -30 U/L -22 U/L 10 PD Analysis Set; Pre-planned sensitivity analysis; MMRM LS Mean; * p<0.05; ** p<0.01; *** p<0.001 versus placeboBIO89-100 Significantly Reduces ALT Percent Change Over Time Percent Change from Baseline at Week 13 QW Q2W Baseline W7 W13 Placebo 3mg 9mg 18mg 27mg 18mg 36mg 20% -4% -10% 0% -17% * -19% -20% * * * -30% -27% -27% ** * * * *** *** -40% *** *** *** -40% Placebo 3 mg QW 9 mg QW *** 18 mg QW 27 mg QW 18 mg Q2W -44% 36 mg Q2W -60% -50% Absolute change: -30 U/L -22 U/L 10 PD Analysis Set; Pre-planned sensitivity analysis; MMRM LS Mean; * p<0.05; ** p<0.01; *** p<0.001 versus placebo
BIO89-100 has Clinically Meaningful Impact on Subjects with High ALT Absolute Change in ALT (U/L) Absolute Change in ALT at Week 13 (Baseline ALT > 45 U/L) (Baseline ALT > 45 U/L) Baseline W4 W7 W13 Pooled Placebo 10 BIO89-100 n=5 n=17 0 0 -10 -10 -10.5 -20 -17 units -20 -30 * -30 Placebo Pooled BIO89-100 -40 * -35 -40 Change in ALT of ≥17 U/L has been correlated with improvement in fibrosis PD Analysis Set in baseline ALT > 45 U/L (placebo n=6, pooled BIO89-100 n=22); Pre-planned sensitivity analysis; MMRM LS Mean; * p<0.05; ** p<0.01; *** p<0.001 versus placebo 11BIO89-100 has Clinically Meaningful Impact on Subjects with High ALT Absolute Change in ALT (U/L) Absolute Change in ALT at Week 13 (Baseline ALT > 45 U/L) (Baseline ALT > 45 U/L) Baseline W4 W7 W13 Pooled Placebo 10 BIO89-100 n=5 n=17 0 0 -10 -10 -10.5 -20 -17 units -20 -30 * -30 Placebo Pooled BIO89-100 -40 * -35 -40 Change in ALT of ≥17 U/L has been correlated with improvement in fibrosis PD Analysis Set in baseline ALT > 45 U/L (placebo n=6, pooled BIO89-100 n=22); Pre-planned sensitivity analysis; MMRM LS Mean; * p<0.05; ** p<0.01; *** p<0.001 versus placebo 11
BIO89-100 Significantly Improves Other Important Liver Biomarkers Despite Low Baseline Values AST PRO-C3 Percent Change from Baseline at Week 13 Percent Change from Baseline at Week 13 QW Q2W QW Q2W Placebo 3mg 9mg 18mg 27mg 18mg 36mg Placebo 3mg 9mg 18mg 27mg 18mg 36mg 0% 10% 3.3% 1.1% -4% -10% 0% -11% -15% -20% -10% -20% -11.2% -12.8% * -25% -20% -30% * -18.8% -29% -19.7% * *** -40% -30% Baseline: 31 U/L Baseline: 11.9 ng/mL -27.7% -38% PD Analysis Set; Pre-planned sensitivity analysis; MMRM LS Mean; * p<0.05; ** p<0.01; *** p<0.001 versus placebo 12BIO89-100 Significantly Improves Other Important Liver Biomarkers Despite Low Baseline Values AST PRO-C3 Percent Change from Baseline at Week 13 Percent Change from Baseline at Week 13 QW Q2W QW Q2W Placebo 3mg 9mg 18mg 27mg 18mg 36mg Placebo 3mg 9mg 18mg 27mg 18mg 36mg 0% 10% 3.3% 1.1% -4% -10% 0% -11% -15% -20% -10% -20% -11.2% -12.8% * -25% -20% -30% * -18.8% -29% -19.7% * *** -40% -30% Baseline: 31 U/L Baseline: 11.9 ng/mL -27.7% -38% PD Analysis Set; Pre-planned sensitivity analysis; MMRM LS Mean; * p<0.05; ** p<0.01; *** p<0.001 versus placebo 12
BIO89-100 Significantly Reduces Triglycerides with Greater Benefit Observed in Subjects with High Triglycerides # Percentage Change from Baseline at Week 13 TG Normalization Rate at week 13 (All Subjects) (Subgroup with Baseline TG ≥200 mg/dL) Placebo Pooled BIO89-100 QW Q2W 60% Placebo 3mg 9mg 18mg 27mg 18mg 36mg 53% 0% -2% 30% 0% -20% -18% 0% -21% N=5 N=15 * -23% -24% * * -28% -28% Decrease from baseline in BIO89-100 treated subgroup with baseline TG ≥200 mg/dL -40% • TG: 33%-49% • Non-HDL: 8%-29% # PD Analysis Set; MMRM LS Mean; * p<0.05; ** p<0.01; *** p<0.001 versus placebo; TG <150 mg/dL 13BIO89-100 Significantly Reduces Triglycerides with Greater Benefit Observed in Subjects with High Triglycerides # Percentage Change from Baseline at Week 13 TG Normalization Rate at week 13 (All Subjects) (Subgroup with Baseline TG ≥200 mg/dL) Placebo Pooled BIO89-100 QW Q2W 60% Placebo 3mg 9mg 18mg 27mg 18mg 36mg 53% 0% -2% 30% 0% -20% -18% 0% -21% N=5 N=15 * -23% -24% * * -28% -28% Decrease from baseline in BIO89-100 treated subgroup with baseline TG ≥200 mg/dL -40% • TG: 33%-49% • Non-HDL: 8%-29% # PD Analysis Set; MMRM LS Mean; * p<0.05; ** p<0.01; *** p<0.001 versus placebo; TG <150 mg/dL 13
BIO89-100 Significantly Improves Key Lipid Markers Percentage Change from Baseline At Week 13 Non-HDL LDL-c HDL-c QW Q2W QW Q2W 25% *** 20% 5% 5% * 20% 3% 18% 1% 1% 0% 0% 15% 11% -2% 10% 9% -5% -5% 10% -4% -5% -6% -6% -6% -8% 5% -10% -10% 3% 2% * 0% -15% -15% * -14% -14% * ** -16% -16% QW Q2W -20% -20% PD Analysis Set; MMRM LS Mean; * p<0.05; ** p<0.01; *** p<0.001 versus placebo 14 14BIO89-100 Significantly Improves Key Lipid Markers Percentage Change from Baseline At Week 13 Non-HDL LDL-c HDL-c QW Q2W QW Q2W 25% *** 20% 5% 5% * 20% 3% 18% 1% 1% 0% 0% 15% 11% -2% 10% 9% -5% -5% 10% -4% -5% -6% -6% -6% -8% 5% -10% -10% 3% 2% * 0% -15% -15% * -14% -14% * ** -16% -16% QW Q2W -20% -20% PD Analysis Set; MMRM LS Mean; * p<0.05; ** p<0.01; *** p<0.001 versus placebo 14 14
BIO89-100 Effect on Glycemic Control Change From Baseline At Week 13 Placebo 3mg QW 9mg QW 18mg QW 27mg QW 18mg Q2W 36mg Q2W Adiponectin * * * *** * -4.3% 37.7% 25.5% 29.1% 60.9% 23.1% 24.1% Percentage Change & Insulin 10.0% -8.5% -9.4% -22.5% -6.9% -39.7% -34.5% Percentage Change HbA1c (%) <0.1 0.6 0.1 0.1 -0.3 -0.1 0.5 Absolute Change No meaningful changes in weight were observed, except in the 27 mg QW cohort that saw a significant percentage reduction in weight relative to placebo & PD Analysis Set; MMRM LS Mean; * p<0.05; ** p<0.01; *** p<0.001 versus placebo Week7 (last measurement) 15BIO89-100 Effect on Glycemic Control Change From Baseline At Week 13 Placebo 3mg QW 9mg QW 18mg QW 27mg QW 18mg Q2W 36mg Q2W Adiponectin * * * *** * -4.3% 37.7% 25.5% 29.1% 60.9% 23.1% 24.1% Percentage Change & Insulin 10.0% -8.5% -9.4% -22.5% -6.9% -39.7% -34.5% Percentage Change HbA1c (%) <0.1 0.6 0.1 0.1 -0.3 -0.1 0.5 Absolute Change No meaningful changes in weight were observed, except in the 27 mg QW cohort that saw a significant percentage reduction in weight relative to placebo & PD Analysis Set; MMRM LS Mean; * p<0.05; ** p<0.01; *** p<0.001 versus placebo Week7 (last measurement) 15
Safety Overview Treatment Emergent Placebo 3mg QW 9mg QW 18mg QW 27mg QW 18mg Q2W 36mg Q2W Adverse Event (TEAE) (n=18) (n=7) (n=12) (n=11) (n=10) (n=14) (n=9) TEAE Leading to Death 0 0 0 0 0 0 0 TEAE Leading to a b 0 0 0 0 1 1 0 Discontinuation Serious Adverse Event 0 0 0 0 0 1 1 COVID 19 [Not Drug Related] a b skin rash; hyperglycemia [Not Drug Related] Safety Analysis Set; one placebo subject received one dose of BIO89-100 3mg and is summarized in 3mg QW group 16Safety Overview Treatment Emergent Placebo 3mg QW 9mg QW 18mg QW 27mg QW 18mg Q2W 36mg Q2W Adverse Event (TEAE) (n=18) (n=7) (n=12) (n=11) (n=10) (n=14) (n=9) TEAE Leading to Death 0 0 0 0 0 0 0 TEAE Leading to a b 0 0 0 0 1 1 0 Discontinuation Serious Adverse Event 0 0 0 0 0 1 1 COVID 19 [Not Drug Related] a b skin rash; hyperglycemia [Not Drug Related] Safety Analysis Set; one placebo subject received one dose of BIO89-100 3mg and is summarized in 3mg QW group 16
Treatment Emergent Adverse Event in ≥ 10% of Pooled BIO89-100 Group Pooled Preferred Term Placebo 3mg QW 9mg QW 18mg QW 27mg QW 18mg Q2W 36mg Q2W BIO89-100 n (%) (n=18) (n=7) (n=12) (n=11) (n=10) (n=14) (n=9) (n=63) Increased Appetite 0 15.9% 4 2 0 2 2 0 Diarrhea 22.2% 12.7% 1 2 0 2 1 2 Headache 5.6% 11.1% 1 0 0 2 2 2 • GI adverse events were similar to placebo; 7.9% of subjects reported nausea in pooled BIO89-100 vs. 16.7% in placebo • No hypersensitivity AE reported; few mild injection site reaction events reported • No tremor reported; no adverse effects on blood pressure or heart rate • Only treatment related AE reported in ≥10% of pooled BIO89-100 group was mild increased appetite Safety Analysis Set; one placebo subject received one dose of BIO89-100 3mg and is summarized in 3mg QW group 17Treatment Emergent Adverse Event in ≥ 10% of Pooled BIO89-100 Group Pooled Preferred Term Placebo 3mg QW 9mg QW 18mg QW 27mg QW 18mg Q2W 36mg Q2W BIO89-100 n (%) (n=18) (n=7) (n=12) (n=11) (n=10) (n=14) (n=9) (n=63) Increased Appetite 0 15.9% 4 2 0 2 2 0 Diarrhea 22.2% 12.7% 1 2 0 2 1 2 Headache 5.6% 11.1% 1 0 0 2 2 2 • GI adverse events were similar to placebo; 7.9% of subjects reported nausea in pooled BIO89-100 vs. 16.7% in placebo • No hypersensitivity AE reported; few mild injection site reaction events reported • No tremor reported; no adverse effects on blood pressure or heart rate • Only treatment related AE reported in ≥10% of pooled BIO89-100 group was mild increased appetite Safety Analysis Set; one placebo subject received one dose of BIO89-100 3mg and is summarized in 3mg QW group 17
BIO89-100 Has a Favorable Clinical Profile Relative to Leading Classes in Development for NASH Relative Reduction in Liver Fat versus Placebo FGF21 FGF19 THRB FXR GLP-1 BIO89-100 Efruxifermin Pegbelfermin Aldafermin Resmetirom OCA Liraglutide 24 weeks 72 weeks 12 weeks 16 weeks 16 weeks 12 weeks 24 weeks 27mg QW 36mg Q2W 28mg QW 50mg QW 10mg QD 20 mg QW 1mg QD 80-100mg QD 25mg QD 1.2mg QD (n=10) (n=9) (n=19) (n=20) (n=23) (n=22) (n=53) (n=78) (n=40) (n=68) 0% -20% -17% -20% -26% -26% * -31% -32% -40% -60% -60% -63% -70% -71% -80% Note: All data regarding third-party studies on this slide are based on third-party trials, some of which are in different stages of development. Conclusions on this slide are not based in head-to-head results. Efficacy shown here may change in future clinical trials 18 *Not placebo-controlledBIO89-100 Has a Favorable Clinical Profile Relative to Leading Classes in Development for NASH Relative Reduction in Liver Fat versus Placebo FGF21 FGF19 THRB FXR GLP-1 BIO89-100 Efruxifermin Pegbelfermin Aldafermin Resmetirom OCA Liraglutide 24 weeks 72 weeks 12 weeks 16 weeks 16 weeks 12 weeks 24 weeks 27mg QW 36mg Q2W 28mg QW 50mg QW 10mg QD 20 mg QW 1mg QD 80-100mg QD 25mg QD 1.2mg QD (n=10) (n=9) (n=19) (n=20) (n=23) (n=22) (n=53) (n=78) (n=40) (n=68) 0% -20% -17% -20% -26% -26% * -31% -32% -40% -60% -60% -63% -70% -71% -80% Note: All data regarding third-party studies on this slide are based on third-party trials, some of which are in different stages of development. Conclusions on this slide are not based in head-to-head results. Efficacy shown here may change in future clinical trials 18 *Not placebo-controlled
BIO89-100 – Demonstrating the Promise of FGF21 in NASH SIGNIFICANT LIVER FAT REDUCTION IMPRESSIVE RESPONDER RATES AT HIGH THRESHOLD (≥50% FAT REDUCTION) LARGE, CLINICALLY MEANINGFUL CHANGES IN ALT ROBUST LIPID CHANGES – TRIGLYCERIDES, NON-HDL, LDL FAVORABLE SAFETY AND TOLERABILITY PROFILE WITH LIMITED GI EVENTS UNIQUE DOSING REGIMEN – FIRST EVERY TWO-WEEK FGF21 ANALOG 19BIO89-100 – Demonstrating the Promise of FGF21 in NASH SIGNIFICANT LIVER FAT REDUCTION IMPRESSIVE RESPONDER RATES AT HIGH THRESHOLD (≥50% FAT REDUCTION) LARGE, CLINICALLY MEANINGFUL CHANGES IN ALT ROBUST LIPID CHANGES – TRIGLYCERIDES, NON-HDL, LDL FAVORABLE SAFETY AND TOLERABILITY PROFILE WITH LIMITED GI EVENTS UNIQUE DOSING REGIMEN – FIRST EVERY TWO-WEEK FGF21 ANALOG 19
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