Marea Therapeutics, a Subsidiary of Lisata Therapeutics, Announces MAR001 Reduces Triglycerides Without Worsening Glycemic Control in Phase 2b TYDAL-TIMI 78 Trial; Results Presented as AHA 2026 Late-Breaker and Published in The New England Journal of Medicine

Marea is also developing MAR005, a half-life-extended version of MAR001, as its planned Phase 3 candidate.

Rhea-AI Summary

Lisata Therapeutics (LSTA) subsidiary Marea reported that MAR001 met all objectives in Part A of the Phase 2b TYDAL-TIMI 78 trial. In 235 adults, placebo-adjusted fasting triglyceride reductions were 39.1%–45.5% at Week 12 across three doses (p<0.001), sustained through Week 24. Reductions reached up to 57.2% versus placebo in participants with baseline triglycerides ≥300 mg/dL, and up to 72.2% from baseline in those with levels ≥500 mg/dL.

At 900 mg, 51.7% reached triglycerides below 150 mg/dL versus 3.4% on placebo. Remnant cholesterol fell 37.3%–40.8% versus placebo. Through 24 weeks, adverse events occurred in 69.5% versus 77.6% on placebo, with no pancreatitis, deaths or worsening of HbA1c, a blood-sugar measure. Part B is enrolling approximately 100 participants with severe hypertriglyceridemia, or very high triglycerides. Results were presented at AHA Scientific Sessions 2026 and published in The New England Journal of Medicine.

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Positive

• Major pointMAR001 met all Part A objectives, including the primary endpoint at every dose.
• Moderate pointPart B enrollment initiated, targeting approximately 100 participants with severe hypertriglyceridemia.
• Minor pointWeek 12 placebo-adjusted triglyceride reductions: 39.1%, 40.9% and 45.5% at 300, 450 and 900 mg, respectively; all p<0.001.
• Minor pointTriglyceride reductions were sustained through Week 24.
• Minor pointBaseline triglycerides ≥300 mg/dL: Week 12 placebo-adjusted reductions of 52.8%, 53.7%, 57.2% at 300, 450, 900 mg, respectively; all p<0.001.

7 minor points

• Minor pointParticipants with baseline triglycerides ≥500 mg/dL achieved reductions from baseline of up to 72.2%.
• Minor pointWeek 12 triglycerides below 150 mg/dL: 31.0%, 35.1%, 51.7% at 300, 450, 900 mg versus 3.4% placebo; all p<0.001.
• Minor pointWeek 12 placebo-adjusted remnant cholesterol reductions were 37.3%–40.8% across doses; all p<0.001.
• Minor pointThrough 24 weeks, adverse events were 69.5% versus 77.6%; serious events 2.8% versus 6.9%, MAR001 versus placebo.
• Minor pointInjection-site reactions through 24 weeks occurred in 14.1% versus 19.0%, MAR001 versus placebo.
• Minor pointThrough 24 weeks, there were no pancreatitis cases or deaths, and no worsening of blood-sugar markers.
• Minor point. Forward-looking: it has not happened yet and may not happen.MAR005 is under development as Marea’s planned Phase 3 candidate, with an extended half-life and improved pharmacokinetic profile.

Negative

• None.

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Key Figures

Part A participants: 235 adults Fasting triglyceride reduction: 39.1%–45.5%; p<0.001 for all doses Reduction at baseline triglycerides ≥300 mg/dL: Up to 57.2% +5 more

Part A participants

235 adults

Randomized, placebo-controlled TYDAL-TIMI 78 trial

Fasting triglyceride reduction

39.1%–45.5%; p<0.001 for all doses

Placebo-adjusted at Week 12 across three doses

Reduction at baseline triglycerides ≥300 mg/dL

Up to 57.2%

Placebo-adjusted at Week 12

Reduction at baseline triglycerides ≥500 mg/dL

Up to 72.2%

Reduction from baseline

Reached normal triglyceride levels

51.7% vs. 3.4% on placebo

900 mg dose; fasting triglycerides <150 mg/dL at Week 12

Remnant cholesterol reduction

37.3%–40.8%; p<0.001 for all doses

Placebo-adjusted at Week 12

Serious adverse events

2.8% vs. 6.9% on placebo

Through 24 weeks

Part B planned enrollment

Approximately 100 participants

Participants with sHTG; fasting triglycerides of 450 to 2,000 mg/dL

Key Terms

severe hypertriglyceridemia, angiopoietin-like protein 4, hba1c, double-blind, +1 more

5 terms

severe hypertriglyceridemia medical

"strongly support MAR001’s potential in severe hypertriglyceridemia (sHTG)"

An extreme elevation of triglycerides, the fat particles carried in the blood, that can overwhelm the body’s ability to process them and sharply raise the risk of acute pancreatitis and other complications. Think of blood as a river and triglycerides as oil — when levels get too high the flow and nearby organs can be damaged. Investors care because it drives demand for treatments, affects clinical trial safety and regulatory review, and can influence healthcare costs, reimbursement and company valuations.

angiopoietin-like protein 4 medical

"targeting angiopoietin-like protein 4 (ANGPTL4)"

A secreted glycoprotein encoded by the ANGPTL4 gene that regulates lipid and vascular biology; it inhibits the enzyme lipoprotein lipase to slow triglyceride clearance from blood and also modulates blood-vessel growth, permeability and inflammation. ANGPTL4 exists in full-length and cleaved forms with different tissue effects, and its actions can vary by context (for example, promoting or inhibiting angiogenesis depending on the setting). In clinical and regulatory communications it is discussed as a biomarker or therapeutic target in metabolic disease, cancer, and cardiovascular research, not to be confused with the angiopoietin family despite the similar name.

hba1c medical

"including no worsening of HbA1c"

A1c (HbA1c) is a blood test that measures how much sugar has stuck to red blood cells over the past two to three months, giving a single number that reflects average blood glucose control—think of it as a running average score for blood sugar. Investors watch A1c because it’s a common clinical measure used to judge whether diabetes drugs, devices or care programs work, influence regulatory approvals, treatment guidelines and market demand.

double-blind technical

"randomized, double-blind, placebo-controlled TYDAL-TIMI 78 trial"

A double-blind process means that neither the people conducting an activity nor the people involved know certain key details, such as who is receiving a treatment or a placebo. This approach helps prevent bias from influencing the results, making the outcome more trustworthy. For investors, it ensures that decisions or judgments are based on unbiased information rather than preconceived opinions or expectations.

pharmacokinetic profile medical

"with an improved pharmacokinetic profile"

The pharmacokinetic profile describes how a drug moves through the body over time, including how quickly it is absorbed, how it spreads, and how it is eventually eliminated. For investors, understanding this profile helps gauge the drug’s effectiveness, safety, and the appropriate dosing schedule, which can influence a company’s potential success and market value. It provides insight into how a medication behaves, impacting its overall commercial viability.

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Part A of TYDAL-TIMI 78 Trial met all objectives, with statistically significant placebo-adjusted triglyceride reductions of 39.1%–45.5% across all three doses at Week 12 and up to 57.2% in participants with baseline triglycerides ≥300 mg/dL

Reductions from baseline of up to 72.2% in participants with triglycerides ≥500 mg/dL strongly support MAR001’s potential in severe hypertriglyceridemia (sHTG); Part B of TYDAL-TIMI 78 trial now enrolling sHTG participants

Favorable and differentiated safety profile, with adverse event rates similar to placebo and no worsening of HbA1c

SOUTH SAN FRANCISCO, Calif. and LIBERTY CORNER, N.J., Nov. 09, 2026 (GLOBE NEWSWIRE) -- Marea Therapeutics, Inc. (“Marea”), a subsidiary of Lisata Therapeutics, Inc. (Nasdaq: LSTA) (“Lisata”), today announced that MAR001, its potential first-in-class monoclonal antibody product candidate targeting angiopoietin-like protein 4 (ANGPTL4), met all objectives in Part A of the Phase 2b TYDAL-TIMI 78 trial, reducing triglycerides by up to 72.2% from baseline in participants with triglycerides ≥500 mg/dL, along with a generally favorable and potentially differentiating safety profile including no worsening of HbA1c. The data are being presented today as a late-breaking clinical trial at the American Heart Association (AHA) Scientific Sessions 2026 and were simultaneously published in The New England Journal of Medicine(NEJM).

MAR001 met the primary endpoint at every dose, with statistically significant placebo-adjusted reductions in fasting triglycerides of 39.1% to 45.5% at Week 12 (p<0.001 for all doses), sustained through Week 24. Triglyceride lowering deepened as baseline levels rose: placebo-adjusted reductions reached up to 57.2% in participants with baseline triglycerides ≥300 mg/dL, and reductions from baseline reached up to 72.2% in participants with triglycerides ≥500 mg/dL. At the 900 mg dose, 51.7% of participants reached normal triglyceride levels (<150 mg/dL), versus 3.4% on placebo. MAR001 also significantly reduced remnant cholesterol and was generally well tolerated through 24 weeks, with no cases of pancreatitis and no glycemic signal versus placebo, as measured by HbA1c, a key consideration for the up to 70% of patients with sHTG who also have type 2 diabetes. Marea has initiated enrollment in Part B of TYDAL-TIMI 78 in participants with sHTG.

sHTG substantially increases the risk of acute pancreatitis, a painful, often recurrent and potentially life-threatening condition. Because many people with sHTG also live with type 2 diabetes, obesity or cardiovascular disease, new treatments need to lower triglycerides enough to help prevent pancreatitis without worsening glycemic control or cardiovascular risk.

“MAR001 delivered on every objective in Part A, and we believe these data provide compelling clinical validation of ANGPTL4 inhibition,” said Josh Lehrer, M.D., president and chief operating officer of Lisata Therapeutics and chief executive officer of Marea Therapeutics. “Triglyceride lowering was greatest in those with the highest baseline levels, with no glycemic signal versus placebo. People with sHTG need a therapy that can help prevent pancreatitis without worsening the diabetes and cardiovascular risk so many of them already carry, and we believe MAR001/MAR005 has the potential to be that therapy. We are now advancing into Part B in sHTG with strong momentum.”

“The TYDAL-TIMI 78 Part A results provide important clinical evidence supporting ANGPTL4 inhibition as a promising new approach to treating hypertriglyceridemia,” said Michelle L. O’Donoghue, M.D., MPH, McGillycuddy-Logue Endowed Chair in Cardiology at Brigham and Women’s Hospital, Associate Professor of Medicine at Harvard Medical School and Senior Investigator, TIMI Study Group. “We observed significant reductions in triglycerides and remnant cholesterol across all three doses of MAR001, with even greater triglyceride lowering in participants with higher baseline levels. These findings are particularly encouraging given the need for additional treatment options for sHTG, where many remain at risk for serious complications including acute pancreatitis despite currently available therapies.”

Key Results from Part A of the Phase 2b TYDAL-TIMI 78 Trial

Part A of the randomized, double-blind, placebo-controlled TYDAL-TIMI 78 trial dosed 235 adults with elevated triglycerides and remnant cholesterol. Participants were randomized to subcutaneous MAR001 300 mg, 450 mg or 900 mg, or placebo, every four weeks for 24 weeks.

Data highlights:

• Primary endpoint met at every dose. At Week 12, MAR001 achieved placebo-adjusted reductions in fasting triglycerides of 39.1%, 40.9% and 45.5% at 300 mg, 450 mg and 900 mg, respectively (p<0.001 for all doses). Reductions were sustained through Week 24.
• Deeper lowering at higher baseline triglycerides, supporting development in sHTG. Among participants with baseline triglycerides ≥300 mg/dL, placebo-adjusted reductions were 52.8%, 53.7% and 57.2% at 300 mg, 450 mg and 900 mg, respectively, at Week 12 (p<0.001 for all doses). Among participants with baseline triglycerides ≥500 mg/dL, reductions from baseline reached up to 72.2%.
• More than half of participants at 900 mg reached normal triglyceride levels. At Week 12, 31.0%, 35.1% and 51.7% of participants receiving MAR001 at 300 mg, 450 mg and 900 mg, respectively, reached fasting triglycerides below 150 mg/dL, compared with 3.4% on placebo (p<0.001 vs. placebo for all doses).
• Significant reductions in remnant cholesterol. MAR001 achieved placebo-adjusted reductions in fasting remnant cholesterol of 37.3% to 40.8% across the three doses at Week 12 (p<0.001 for all doses). Remnant cholesterol, carried in triglyceride-rich lipoprotein remnants, is increasingly recognized as a contributor to cardiovascular risk.
• Favorable safety and tolerability, with no worsening of HbA1c. Through 24 weeks, treatment-emergent adverse events occurred in 69.5% of MAR001-treated participants vs. 77.6% on placebo; serious adverse events in 2.8% vs. 6.9%; and injection-site reactions in 14.1% vs. 19.0%. There were no cases of pancreatitis and no deaths, and no worsening of HbA1c or other markers of glucose homeostasis was observed.
  

Marea has initiated enrollment in Part B of TYDAL-TIMI 78, which is designed to enroll approximately 100 participants with sHTG (fasting triglycerides of 450 to 2,000 mg/dL) randomized 1:1 to MAR001 or placebo, administered subcutaneously every four weeks. Marea is also developing MAR005, a half-life-extended version of MAR001 with an improved pharmacokinetic profile, as its planned Phase 3 candidate.

About MAR001/MAR005
MAR001 is a potential first-in-class monoclonal antibody in clinical development that targets ANGPTL4, a protein that is highly expressed in adipose tissue. By inhibiting ANGPTL4 and thereby augmenting lipoprotein lipase (LPL) activity, MAR001 is designed to lower triglycerides and improve adipose tissue function. Human genetic data have identified ANGPTL4 as a highly promising therapeutic target because loss-of-function alleles lead to lower triglyceride levels, improved adipose distribution, better insulin sensitivity, and protection from cardiovascular disease and type 2 diabetes.

MAR005, a half-life-extended version of MAR001 with an improved pharmacokinetic profile, is Marea's planned Phase 3 candidate and is in clinical development for the treatment of severe hypertriglyceridemia (sHTG), a condition characterized by very high triglyceride levels. Preclinical models with MAR001 demonstrated reduction in triglycerides, remnant cholesterol and ectopic fat, and improved insulin sensitivity. MAR001 has demonstrated strong Phase 1 and 2a results and is in Phase 2b clinical development.

About Marea Therapeutics
Marea Therapeutics is a clinical-stage biotechnology company harnessing the latest advances in human genetics to develop first-in-class, next-generation medicines for cardioendocrine diseases. The company’s lead product candidate, MAR001, is in Phase 2b clinical development for the treatment of severe hypertriglyceridemia (sHTG), a condition characterized by very high triglyceride levels. The company is also advancing MAR002 for the treatment of acromegaly.

About Lisata Therapeutics
Lisata Therapeutics is a clinical-stage pharmaceutical company. Following its acquisition of Marea, Lisata’s lead product candidate is MAR001, which is in Phase 2b clinical development for the treatment of severe hypertriglyceridemia (sHTG), a condition characterized by very high triglyceride levels. The company is also advancing MAR002 for the treatment of acromegaly.

Cautionary Note Regarding Forward-Looking Statements
Certain statements in this press release, other than purely historical information, may constitute “forward-looking statements” within the meaning of the federal securities laws, including for purposes of the safe harbor provisions under the United States Private Securities Litigation Reform Act of 1995, concerning Lisata and Marea, including the acquisition of Marea by Lisata (the “Transaction”) and other matters. These forward-looking statements include, but are not limited to, express or implied statements relating to the company’s expectations, hopes, beliefs, intentions or strategies regarding the future including, without limitation, statements regarding expectations regarding or plans for the company’s pipeline, including its ongoing and planned clinical trials, research and development programs and the expected timing for key milestones; the design, results and presentation of data from the Phase 2b TYDAL-TIMI 78 study of MAR001; plans for the Phase 3 development of MAR005, including as a successor to MAR001; the potential for MAR001/MAR005 to be a first-in-class therapy; and the potential benefits of MAR001/MAR005 and MAR002. In addition, any statements that refer to projections, forecasts or other characterizations of future events or circumstances, including any underlying assumptions, are forward-looking statements. The words “opportunity,” “potential,” “milestones,” “pipeline,” “can,” “goal,” “aim,” “strategy,” “target,” “seek,” “anticipate,” “achieve,” “believe,” “contemplate,” “continue,” “could,” “estimate,” “expect,” “intends,” “may,” “might,” “plan,” “possible,” “predict,” “project,” “should,” “will,” “would” and similar expressions (including the negatives of these terms or variations of them) may identify forward-looking statements, but the absence of these words does not mean that a statement is not forward-looking. These forward-looking statements are based on current expectations and beliefs concerning future developments and their potential effects. There can be no assurance that future developments affecting the company or the Transaction will be those that have been anticipated. These forward-looking statements involve a number of risks, uncertainties (some of which are beyond the company’s control) or other assumptions that may cause actual results or performance to be materially different from those expressed or implied by these forward-looking statements. These risks and uncertainties include, but are not limited to: the risk that data presented at the American Heart Association Scientific Sessions 2026 or in subsequent analyses may differ from, or be interpreted differently than, previously reported or topline data; the risk that results of earlier clinical trials, including the TYDAL-TIMI 78 study, may not be predictive of results of later-stage clinical trials; the risk that MAR005 may not replicate, or reflect any improvements over, the pharmacokinetic, safety or efficacy profile of MAR001; the timing and outcome of interactions with, and approvals from, regulatory authorities; the company’s need for substantial additional capital to fund its operations and product development; and those uncertainties and factors described under the heading “Risk Factors” in Lisata’s Annual Report on Form 10-K for the year ended December 31, 2025, filed with the Securities and Exchange Commission (the “SEC”) on March 12, 2026 or its subsequent Quarterly Reports on Form 10-Q filed with the SEC, as well as discussions of potential risks, uncertainties, and other important factors included in other filings by the company from time to time, together with risk factors associated with companies, such as Marea, that operate in the biotechnology industry. Should one or more of these risks or uncertainties materialize, or should any of the company’s assumptions prove incorrect, actual results may vary in material respects from those projected in these forward-looking statements. Nothing in this press release should be regarded as a representation by any person that the forward-looking statements set forth herein will be achieved or that any of the contemplated results of such forward-looking statements will be achieved. You should not place undue reliance on forward-looking statements in this press release, which speak only as of the date they are made and are qualified in their entirety by reference to the cautionary statements herein. Except as required by applicable law, the company does not undertake or accept any duty to release publicly any updates or revisions to any forward-looking statements. This press release does not purport to summarize all of the conditions, risks and other attributes of an investment in the company.

Contacts:

Lisata:

Investors and Media:
John Menditto
jmenditto@lisata.com

Marea:

Media:
1AB
Katie Engleman
katie@1abmedia.com

Investors:
Meru Advisors
Lauren Glaser
lglaser@meruadvisors.com

FAQ

AI-generated questions and answers. How Rhea-AI works. Not financial advice.

What did Lisata subsidiary Marea’s MAR001 Phase 2b trial show?

MAR001 met the primary endpoint at every dose, with 39.1%–45.5% placebo-adjusted reductions in fasting triglycerides at Week 12 (p<0.001 for all doses). Reductions were sustained through Week 24. Participants with baseline triglycerides ≥500 mg/dL had reductions from baseline of up to 72.2%.

Did MAR001 worsen blood-sugar control in Marea’s TYDAL-TIMI 78 trial?

No worsening of HbA1c or other markers of glucose homeostasis was observed through 24 weeks. Treatment-emergent adverse events occurred in 69.5% of MAR001-treated participants versus 77.6% on placebo. There were no cases of pancreatitis and no deaths.

How is Part B of Marea’s TYDAL-TIMI 78 trial designed?

Part B is designed to enroll approximately 100 participants with fasting triglycerides of 450 to 2,000 mg/dL, randomized 1:1 to MAR001 or placebo. Treatment is administered by injection under the skin every four weeks. Enrollment has begun.

How was Part A of Marea’s TYDAL-TIMI 78 trial conducted?

Part A was a randomized, double-blind, placebo-controlled trial that dosed 235 adults with elevated triglycerides and remnant cholesterol. Participants received MAR001 at 300 mg, 450 mg or 900 mg, or placebo, by injection under the skin every four weeks for 24 weeks.