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Company to Highlight the complete solution to the GLP-1R weight regain crisis: Only All-Oral Dual-Mechanism Metabolic Platform in Clinical Development, Featuring First-in-Class Oral GLP-1R Agonist and Muscle-Selective AMPK Activator

LEHI, Utah — January 09, 2026 — Biolexis Therapeutics, a clinical-stage biotechnology company pioneering an all-oral infrastructure for metabolic disease, today announced it will present at the 44th Annual J.P. Morgan Healthcare Conference on Thursday, January 15, 2026 at 9:00am PST.

The presentation will spotlight Biolexis’ differentiated strategy to overcome the maintenance, side effect, scalability, and access crises with existing market therapies for weight loss. To solve these issues, the company has two clinical-stage programs:

• BLX-7006 — A best-in-human oral small-molecule allosteric GLP-1R  agonist based on a new chemical scaffold. Phase 1 data demonstrates a clean safety profile once-daily pharmacokinetics, and the asset is now advancing to Phase 2 development.

• BLX-0871 — A first-in-class γ3 isoform-selective AMPK activator designed to preserve lean muscle mass and metabolic durability, entering Phase 1 in January 2026

BLX-7006: Redefining GLP-1 Access

BLX-7006 binds a distinct allosteric pocket on the GLP-1 receptor, enabling cooperative activation while reducing receptor desensitization—a key limitation of peptide-based therapies. As a small molecule, BLX-7006 offers transformative advantages: oral administration without fasting requirements, no cold-chain logistics, and a fundamentally lower cost-of-goods structure enabling global-scale deployment.

BLX-0871: Solving the Muscle Loss Problem

While existing GLP-1 therapies achieve meaningful weight loss, up to 25-40% of that lost can be lean mass, driving metabolic adaptation and weight regain. BLX-0871 selectively activates γ3-containing AMPK complexes enriched in skeletal muscle, engaging exercise-associated metabolic pathways while sparing cardiac isoforms. This leads to preserved lean mass, improved glucose utilization, and sustained metabolic rate.

The All-Oral Combination Advantage

Biolexis is developing the only all-oral dual-mechanism combination currently in clinical development. By pairing GLP-1R-mediated appetite suppression with muscle-selective AMPK activation, the company aims to deliver what injectable monotherapies cannot: durable weight loss with preserved muscle mass and metabolic function.

“The GLP-1R revolution has proven we can treat obesity—but injectable peptides alone won’t get us to a billion patients,” said David J. Bearss, PhD, Co-founder and Chairman of Biolexis Therapeutics. “Our all-oral platform isn’t an incremental improvement—it’s infrastructure for global scale. And by adding muscle-selective AMPK activation, we’re not just helping patients lose weight, we’re helping them keep it off. That’s the durability breakthrough the field has been waiting for.”

Conference Availability

Biolexis management will be available throughout the conference for meetings with pharmaceutical companies, institutional investors, and strategic partners to discuss Phase 2 clinical plans, combination development strategy, and partnership opportunities.

About Biolexis Therapeutics

Biolexis Therapeutics is a clinical-stage biotechnology company headquartered in Lehi, Utah, building an all-oral infrastructure for metabolic disease. By combining novel small-molecule GLP-1 receptor agonism with isoform-selective AMPK activation, Biolexis is developing scalable, muscle-sparing, durable metabolic therapies designed for global deployment. For more information, visit www.biolexistx.com.

Forward-Looking Statements

This press release contains forward-looking statements within the meaning of applicable securities laws. These statements involve risks and uncertainties that could cause actual results to differ materially, including risks related to clinical trial outcomes, regulatory approvals, and market conditions. Biolexis undertakes no obligation to update forward-looking statements.

Media Contact:

Kyle Medley

kmedley@biolexistx.com

453.893.5473

Dr. Jeremiah Bearss, MD, PhD, to Present Groundbreaking Research on Exercise Mimetics and Lead Panel Discussion on Redefining Success in Obesity Care

SALT LAKE CITY, December 2,2025 — Biolexis Therapeutics, an emerging leader in next-generation metabolic and inflammation-targeted therapies, today announced that Jeremiah Bearss, MD, PhD, Vice President of Clinical Development, has been selected to deliver two featured presentations at the 2nd Innovation in Obesity Therapeutics Summit—the leading global forum accelerating development of the next wave of obesity treatments. The Summit brings together leading scientists and executives from Novo Nordisk, Eli Lilly, Boehringer Ingelheim, and other industry pioneers.

Dr. Bearss’s dual selection underscores Biolexis’s growing reputation as a scientific leader in the rapidly evolving obesity therapeutics landscape, where next-generation approaches are urgently needed to address the limitations of current weight-loss treatments.

“The obesity field is at an inflection point. While current GLP-1 therapies have demonstrated remarkable efficacy for weight loss, we’re increasingly recognizing that weight on a scale tells only part of the story,” said Dr. Bearss. “At Biolexis, we’re pioneering approaches that not only promote weight loss but also preserve and enhance muscle mass—fundamentally changing what therapeutic success looks like for patients.”

SCIENTIFIC PRESENTATION

“Integrating Exercise Mimetics to Mimic Physical Activity and Boost Metabolic Rate for Healthier Weight Loss”

Day 1 | 11:30 AM

Dr. Bearss will present Biolexis’s pioneering work developing pharmacologic strategies that reproduce the metabolic effects of endurance training, addressing key mechanisms including:

• Enhancing mitochondrial function to increase fat oxidation and sustain energy expenditure

• Activating muscle-specific signaling pathways that drive glucose uptake and improve insulin sensitivity

• Inducing exercise-responsive gene programs to boost caloric burn—even at rest—offering a novel avenue for sustainable, healthy weight management

PANEL DISCUSSION

“Assessing Functional Readouts & Optimal Muscle-to-Fat Ratio to Redefine Success in Obesity Care”

Dr. Bearss will join senior industry leaders to address critical questions reshaping the obesity therapeutics field:

• The urgent need for functional endpoints—strength, endurance, muscle quality—beyond weight alone

• The emerging scientific consensus around how much muscle loss is too much during obesity treatment

• How muscle-preserving therapeutics can unlock more durable, healthier outcomes than weight reduction alone

STRATEGIC SIGNIFICANCE

With global momentum accelerating behind multi-agonist therapies, muscle-preserving strategies, and next-generation metabolic targets, pressure is mounting to develop best-in-class obesity therapeutics that address the full spectrum of patient needs. Biolexis is uniquely positioned to contribute to this landscape through its deep expertise in AMPK isoform activation, GLP-1 allosteric modulation, and precision metabolic engineering.

“We’re not just treating obesity—we’re working to restore metabolic health and physical function,” added Dr. Bearss. “Our goal is to help patients achieve weight loss that translates into real improvements in how they move, feel, and live.”

Novel Combination of Oral GLP-1 Receptor Agonist BLX-7006 and γ3-Selective AMPK Activator BLX-0871 Demonstrates Superior Weight Loss with Unprecedented Muscle Preservation

[LEHI, UTAH] – October 28, 2025 – Biolexis Therapeutics today announced that Jeremiah Bearss, Ph.D., Vice President of Clinical Development, will present new preclinical data on the company’s innovative dual-mechanism oral therapy for obesity and metabolic diseases at ObesityWeek® 2025.

PRESENTATION DETAILS:

Session Title: Combination Effect of Oral GLP-1R Agonist BLX-7006 and Oral γ3-Selective AMPK Activator BLX-0871

Presenter: Jeremiah Bearss, Ph.D., Vice President of Clinical Development, Biolexis Therapeutics

Date/Time: Wednesday, November 6, 2025, 10:30 AM – 10:45 AM

Location: ObesityWeek® 2025

Key Highlights:

Biolexis’ proprietary combination therapy represents the first all-oral dual-mechanism approach targeting both central appetite regulation and peripheral muscle metabolism. Preclinical data demonstrate:

•      Superior Weight Loss: 25.1% total body weight reduction in diet-induced obesity models, exceeding current market-leading therapies

•      Exceptional Muscle Preservation: 87% lean mass retention compared to approximately 50% with current GLP-1 receptor agonists

•      Novel Mechanisms of Action: BLX-7006 employs allosteric GLP-1 receptor modulation that overcomes receptor desensitization, while BLX-0871 provides tissue-selective AMPK activation targeting skeletal muscle and adipose tissue while sparing cardiac tissue

•      Enhanced Patient Convenience: Once-daily oral administration eliminates injection burden and cold-chain requirements

“Current obesity therapies have transformed the treatment landscape, but significant limitations remain, including substantial muscle loss, injection burden, and adherence challenges,” said Dr. Jeremiah Bearss. “Our dual-mechanism approach addresses these critical unmet needs by combining a novel oral GLP-1 receptor agonist with a precision AMPK activator that preserves muscle mass during weight loss. The preclinical data we’re presenting at ObesityWeek® demonstrate the potential to deliver superior efficacy with an improved safety and convenience profile.”

Addressing Critical Market Needs:

With over 4 billion people projected to be affected by obesity by 2035 and the GLP-1 receptor agonist market expected to reach $268 billion by 2034, there is substantial demand for therapies that overcome current limitations. Up to 50% of weight lost with existing GLP-1 therapies can be lean muscle mass, which negatively impacts metabolic rate and long-term health outcomes. Additionally, up to 40% of patients discontinue injectable therapies within one year due to injection burden and side effects.

Biolexis’ all-oral platform offers several differentiating advantages:

•      Allosteric GLP-1 receptor modulation that prevents desensitization seen with traditional peptide agonists

•      Isoform-selective AMPK activation (α2β1γ3/α2β2γ3) that specifically targets muscle and fat tissue

•      Room temperature stability and standard manufacturing, potentially improving global accessibility

•      Reduced gastrointestinal side effects compared to current therapies

Clinical Development Progress:

Biolexis is currently advancing both BLX-7006 and BLX-0871 through Phase 1 clinical studies, with regulatory approval received in Australia in September 2025. First patient dosing is expected in Q4 2025, with data readouts anticipated in 2026.

About BLX-7006:

BLX-7006 is a novel oral, small-molecule allosteric GLP-1 receptor agonist that activates the GLP-1 receptor through a unique binding site distinct from traditional peptide agonists. This non-competitive mechanism enables cooperative signaling with endogenous GLP-1 and overcomes receptor desensitization that limits chronic peptide therapy. Unlike current oral GLP-1 therapies with limited bioavailability, BLX-7006 demonstrates excellent oral absorption with predictable pharmacokinetics.

About BLX-0871:

BLX-0871 is an isoform-selective AMPK activator that specifically targets α2β1γ3 and α2β2γ3 AMPK complexes predominantly expressed in skeletal muscle and adipose tissue. This precision approach activates exercise-mimetic metabolic pathways that preserve muscle function during caloric deficit while avoiding cardiac AMPK isoforms associated with pathological hypertrophy seen in previous pan-AMPK activator programs.

About Biolexis Therapeutics:

Biolexis Therapeutics is a clinical-stage biopharmaceutical company pioneering innovative oral therapies for metabolic diseases. The company’s proprietary dual-mechanism platform combines novel mechanism GLP-1 receptor agonism with precision AMPK activation to address critical limitations in current obesity and diabetes treatments. Biolexis is committed to developing therapies that improve patient outcomes through superior efficacy, enhanced safety, and convenient administration.

LEHI, Utah – October 8, 2025 – Biolexis Therapeutics, a biopharmaceutical company pioneering transformative treatments for metabolic diseases, today announced the initiation of two first-in-human Phase 1 clinical trials for its lead candidates, BLX-7006 and BLX-0871. These trials, being conducted in Australia, will evaluate the safety, tolerability, and pharmacokinetics of the company’s novel, all-oral, dual-mechanism therapy. This differentiated approach is designed to deliver superior weight loss while preserving critical muscle mass.

The global obesity market is dominated by injectable GLP-1 receptor agonists that, despite their effectiveness, are associated with significant challenges, including injection burden, gastrointestinal side effects, and concerning loss of lean muscle mass intrinsic to overall weight loss. Biolexis aims to overcome these limitations with a first-in-class, synergistic oral platform.

The two clinical trials are:

“Initiating these clinical trials marks a pivotal moment for Biolexis and a potential paradigm shift in how we approach the management of obesity and Type 2 Diabetes,” said Hariprasad Vankayalapati, M.Pharm, PhD, co-founder and Chief Scientific Officer of Biolexis. “Current therapies often force patients to sacrifice muscle for fat loss, which can compromise long-term metabolic health. Our dual-mechanism approach, combining the novel allosteric GLP-1 agonism of BLX-7006 with the targeted, muscle-preserving AMPK activation of BLX-0871, is designed to offer a more effective and sustainable solution for patients. We are thrilled to advance these promising oral agents into the clinic.”

Biolexis is collaborating with leading Australian research partners to conduct these trials. The studies will be managed by the contract research organization Southern Star Research, with participants enrolled at Nucleus Network’s clinical research facility, and bioanalytical services provided by Crux Bio.

About Biolexis’s Dual-Mechanism Platform: The Biolexis platform combines two distinct, orally administered small molecules. BLX-7006 is a novel allosteric GLP-1 receptor agonist designed to enhance satiety and glycemic control while potentially overcoming the receptor desensitization seen with current peptide agonists. BLX-0871 is a first-in-class, isoform-selective AMPK activator that specifically targets skeletal muscle and adipose tissue to increase energy expenditure and preserve muscle mass, avoiding off-target effects that have hindered previous AMPK drug development. Preclinical data has shown this combination can achieve superior weight loss with up to 87% muscle preservation.

About Biolexis

Biolexis is a clinical-stage biopharmaceutical company dedicated to developing innovative oral therapies for metabolic diseases. By pioneering a synergistic, dual-mechanism platform that combines GLP-1 receptor agonism and targeted AMPK activation, Biolexis aims to redefine the standard of care for obesity and type 2 diabetes, focusing on high-quality, muscle-sparing weight loss to improve long-term patient outcomes.

LEHI, Utah, June 12, 2025 /PRNewswire/ — Biolexis Therapeutics, Inc. (www.biolexistx.com), a clinical-stage therapeutics company pioneering next-generation treatments for metabolic and muscle-wasting diseases, today announced the initiation of Phase I clinical trials for its lead GLP-1 and AMPK small molecule programs. These trials, scheduled to begin this August in Australia, represent a major inflection point in Biolexis’ mission to redefine the treatment landscape for obesity, metabolic dysfunction, and muscle degeneration.

Groundbreaking Preclinical Data Propel Clinical Milestone

In preclinical studies, Biolexis’ oral GLP-1 receptor agonist, BLX-7006, resulted in a 29% reduction in weight in diet induced obesity mice. In GLP toxicology studies, BLX-7006 demonstrated no observed adverse events in both Sprague Dawley Rats and Cyno Non-human Primates, supporting a wide therapeutic window and a clean safety profile. The novel chemotype of BLX-7006 and its unique binding mode was also confirmed via Cryo-EM. This structural confirmation provides definitive proof that Biolexis has discovered a new way to activate the GLP-1 receptor allosterically compared to other compounds that are almost exclusively modified analogs of danuglipron and orforglipron.

Concurrently, the company’s isoform-selective AMPK activator, BLX-0871, showed dual benefits in preclinical studies: effective weight reduction and significant preservation of lean muscle mass, addressing a critical unmet need in current obesity treatments. BLX-0871 has demonstrated a favorable safety profile in GLP toxicology studies, with no observed cardiotoxicity at high doses in Sprague Dawley Rats and Beagle Dogs, reinforcing its safety profile in clinical development.

“These results validate our belief that targeting GLP-1 and AMPK pathways—individually or synergistically—can drive meaningful clinical impact,” said Dr. Hari Vankayalapati, Co-founder and Chief Scientific Officer of Biolexis. “We are excited to enter human studies and continue advancing these transformative therapies.” Vankayalapati also noted a Phase I study combining BLX-7006 and BLX-0871 is slated to begin during the second quarter of 2026.

New AMPK Program Targets Aging and Muscle Regeneration

In addition to its lead candidates, Biolexis will continue development of BLX-08155, an isoform-specific AMPK activator identified for its muscle-preserving and regenerative properties. This candidate will advance as a standalone development program targeting age-related sarcopenia and post-surgical muscle recovery, two areas of expanding unmet medical need. The company anticipates BLX-08155 will be ready to enter human studies during the fourth quarter of 2026. “This expansion reflects our strategic focus on fully leveraging AMPK biology,” said Vankayalapati. “BLX-08155 opens new possibilities in longevity medicine and surgical rehabilitation.”

Upcoming BIO International Convention Presentation

Dr. David J. Bearss, Co-founder of Biolexis, will discuss the company’s updated pipeline and clinical development strategy at the BIO International Convention in Boston on June 18, 2025, at 9:30 AM EDT. The presentation will highlight Phase I trial designs for both lead programs and provide a first look at the age-related sarcopenia program.

About Biolexis Therapeutics

Biolexis Therapeutics is a pharmaceutical company committed to developing precision medicines for metabolic and muscle-related diseases. Its pipeline includes first-in-class oral therapies that target the GLP-1 receptor and isoform-specific/selective AMPK signaling, with programs focused on obesity, metabolic dysfunction, age-related sarcopenia, and muscle regeneration. Biolexis is headquartered in Lehi, Utah.

CryoEM Confirms a First-in-Class Allosteric Binding Mode, Validating MolecuLern™ AI-Driven Discovery

LEHI, Utah, March 14, 2025 /PRNewswire/ — Biolexis Therapeutics has achieved a transformative milestone in metabolic drug discovery with the successful resolution of the cryo-electron microscopy (cryoEM) structure of BLX-7006, its first-in-class oral small-molecule GLP-1 receptor agonist. This breakthrough confirms a completely novel allosteric activation mechanism for the GLP-1 receptor, distinct from any previously known approaches.

The cryoEM structural confirmation validates the predictive power of MolecuLern, Biolexis’ AI-enabled drug discovery platform. MolecuLern identified BLX-7006 as a novel small molecule capable of allosterically modulating GLP-1 receptor activity. Unlike many oral small-molecule GLP-1 therapies being developed—whose compounds are almost exclusively modified analogs of existing molecules such as Pfizer’s Danuglipron and Eli Lilly’s Orforglipron—BLX-7006 is a brand-new chemotype with an entirely unique binding mode.

“The cryoEM structural confirmation of BLX-7006 provides definitive proof that we have discovered a new way to activate the GLP-1 receptor allosterically,” said Dr. Hariprasad Vankayalapati, Chief Scientific Officer of Biolexis Therapeutics. “This isn’t just an incremental improvement on existing compounds—it’s a new mechanism enabled by our AI-driven approach to drug discovery. With superior metabolic stability and a more efficient synthesis process, BLX-7006 represents a breakthrough in the quest for next-generation, oral GLP-1 therapies.”

Biolexis is actively completing the toxicology and manufacturing studies necessary to support human clinical testing of BLX-7006. With these critical studies underway, the company plans to initiate first-in-human trials in Q3 2025, marking a major step toward bringing this novel therapy to patients with obesity, type 2 diabetes, and metabolic dysfunction.

Asked to provide additional details on Biolexis’ AI drug discovery platform, Vankayalapati stated, “MolecuLern integrates AI-driven molecular design, wet lab validation, and proprietary structural modeling to identify innovative small molecules for challenging drug targets. The successful cryoEM validation of BLX-7006’s novel binding mode underscores the ability of MolecuLern to accurately predict molecular interactions and accelerate the discovery of first-in-class therapeutics.”

Dec 09, 2024, 08:01 ET

Study Demonstrates 16.6 % at day 7 to 29 % on terminal day 28 Weight Loss and Superior Efficacy Compared to peptide-based approved or clinical stage oral Obesity Drugs in the DIO Model

LEHI, Utah, Dec. 9, 2024 /PRNewswire/ — Biolexis Therapeutics, a leading metabolic drug discovery company focused on improving the lives of patients with chronic metabolic conditions, including obesity, diabetes, and related diseases, today announced the successful completion of an expanded diet–induced obesity (DIO) trial for its candidate drug, BLX-7006. The results demonstrate significant weight loss and superior efficacy compared to leading obesity therapies, including Semaglutide and Orforglipron, providing robust support for BLX-7006’s potential as a transformative treatment for obesity & diabetic indications.

The newly completed study builds upon a previous DIO study in which BLX-7006 demonstrated a promising 15.6 % weight loss. In the expanded study, BLX-7006 achieved a substantial 29% weight loss, attributed to evaluating higher dosage levels. These higher doses were well tolerated, with no observed toxicity, marking an important milestone in the development of BLX-7006 for obesity management.

“We are extremely encouraged by the results of our expanded DIO study, which show a significant improvement in weight loss with BLX-7006 compared to our initial study,” said Dr. Hariprasad Vankayalapati, Chief Scientific Officer at Biolexis Therapeutics. “The higher dosage levels are well tolerated, have yielded a 29% weight loss, which is not only a strong indication of the potential therapeutic benefits of BLX-7006, but also underscores its safety profile, with no evidence of toxicity at these elevated doses in non-clinical animal models. Our findings place BLX-7006 in a competitive position in the obesity treatment space.”

In addition to the DIO study, Biolexis has completed a non-human primate study to assess BLX-7006’s oral bioavailability profile. The study demonstrated high exposure levels, further validating BLX-7006’s potential translation into future human clinical trials. “These results are a testament to the strength of our BLX-7006 program and the dedication of our team in developing novel metabolic therapeutics,” said Keith Marmer, Chief Business Officer of Biolexis Therapeutics. “With the growing global prevalence of obesity and related metabolic disorders, there is a pressing need for more effective oral treatments over current injectables. The compelling results from both our expanded DIO study and the non-human primate study position BLX-7006 as a promising future clinical candidate to address this critical unmet need.”

Biolexis will present these findings and additional data at the upcoming Innovation in Obesity Therapeutics Summit in San Diego, CA, on December 11-12, 2024. Biolexis Co-founder Dr. David Bearss will present the latest data on BLX-7006’s efficacy and its potential to provide a safe, effective, and oral alternative for patients struggling with obesity and related metabolic conditions. “We are excited to share these groundbreaking results with the scientific community at the Innovation in Obesity Therapeutics Summit,” said Dr. Bearss. “As we continue to advance BLX-7006 through clinical development, we remain committed to improving patient outcomes and bringing innovative solutions to the market that can have a meaningful impact on the lives of those affected by chronic metabolic diseases.”

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