Market Newsdesk

ARLINGTON, Mass., April 21, 2026 (GLOBE NEWSWIRE) — KALA BIO, Inc. (NASDAQ: KALA) (“KALA” or the “Company”) today celebrated the landmark Executive Order signed by U.S. President Donald J. Trump on April 18, 2026. The Order directs the FDA to prioritize the review of psychedelic compounds, instructs the DEA to reduce research restrictions, establishes expanded patient access pathways under the Right to Try Act, and allocates $50 million in federal funding to accelerate psychedelic therapy research, representing the most sweeping shift in U.S. federal psychedelic policy in decades.

The Executive Order arrives at a pivotal moment, and KALA is uniquely and strategically positioned to capitalize on this seismic policy shift. KALA congratulates its client, Red Light Holland Corp. (CSE: TRIP) (FSE: 4YX) (OTCQB: TRUFF) (“Red Light”), on this transformative federal policy shift. With expanded patient access pathways, reduced DEA research restrictions, and national priority review signals from the FDA, Red Light’s psychedelic drug development programs are now positioned to advance with materially stronger regulatory and commercial momentum and to deliver on the full clinical and therapeutic promise of its portfolio within a supportive federal framework. KALA is proud that Red Light’s development strategy is supported by KALA’s proprietary Researgency.ai agentic artificial intelligence platform, licensed worldwide from Younet AI.

As disclosed on March 18, 2026, Red Light engaged KALA’s Researgency.ai agentic AI platform, licensed worldwide from Younet AI, to support its clinical development strategy, including clinical planning, protocol optimization, and scenario modelling. Today’s policy announcement reinforces Researgency.ai’s commercial relevance to the psychedelic drug development sector and underscores KALA’s position as the dedicated AI infrastructure partner for the broader biotechnology industry.

“President Trump’s Executive Order is the clearest signal yet that psychedelic medicine is moving from under-researched science to mainstream healthcare, and KALA is already embedded to capitalize on this revolution. We are thrilled to have Red Light Holland as one of our Researgency.ai clients, and today’s policy shift materially strengthens the outlook for their programs. As psychedelic medicine moves toward multi-session, dose-optimized protocols under a supportive federal framework, clinical development becomes materially more complex, with more variables, more patient subgroups, and more decision points. Researgency.ai delivers compounding value by providing secure, on-premises agentic AI applied to proprietary biological and clinical data. We congratulate Red Light on this transformative moment for the industry and look forward to expanding our role as the dedicated AI infrastructure partner for the psychedelic and broader biotech industries,” said Avi Minkowitz, Chief Executive Officer of KALA BIO.

About Researgency.ai

Researgency.ai is an agentic, on-premises AI platform developed by Kala Bio in collaboration with Younet. Designed for secure, scalable deployment in regulatory-compliant biopharmaceutical environments, Researgency.ai enables biotech companies to turn clinical and molecular data into actionable insights for therapeutic optimization, digital health integration, and commercialization.

ABOUT KALA BIO (NASDAQ: KALA)

KALA BIO, Inc. is a clinical-stage biopharmaceutical company building a dedicated, on-premises AI infrastructure platform for the biotechnology industry. The Company’s dual strategy combines a proprietary biologics pipeline—including its mesenchymal stem cell secretome (MSC-S) platform and FDA Orphan Drug- and Fast Track-designated product candidates—with a scalable AI platform-as-a-service business designed to deploy secure, purpose-built AI solutions directly within biotech and pharmaceutical client environments.

Through its exclusive worldwide license for the Researgency AI research platform from Younet, Kala intends to serve as the dedicated AI infrastructure partner for the biotechnology industry, enabling organizations of all sizes to unlock the value of their proprietary biological data without surrendering control. Kala is advancing an agentic transformation strategy for biomedical organizations through Researgency.ai, a platform designed to enable scalable, governed deployment of AI agents across research, documentation, and operational workflows. The Company’s focus on enterprise security, real-time performance, and seamless integration positions it at the forefront of innovation in the life sciences AI sector.

Kala believes the future of biomedical innovation is in agentic systems.

For more information, visit www.kalarx.com and www.Researgency.ai

Forward-Looking Statements

This press release contains forward-looking statements within the meaning of the Private Securities Litigation Reform Act of 1995, including statements regarding the Company’s strategic initiative to build an AI infrastructure platform for the biotechnology industry, plans to develop and deploy the Researgency AI platform both internally and to external clients, expectations regarding the potential benefits of AI-driven analytical tools, plans to reassess historical datasets and identify new therapeutic indications, expectations regarding the AI drug discovery market and industry trends, expectations regarding the Company’s ability to generate recurring platform revenue, plans regarding potential partnerships, client deployments, or technology licensing opportunities, expectations regarding the Company’s competitive position and the differentiation of its on-premises deployment model, the potential exercise of development continuation or renewal options under the Agreement, and other statements that are not historical facts.

The Company used words like “anticipate,” “believe,” “continue,” “could,” “estimate,” “expect,” “intend,” “may,” “might,” “plan,” “potential,” “predict,” “project,” “should,” “target,” “will,” “would” and similar expressions to identify these forward-looking statements. These statements involve known and unknown risks, uncertainties, and other factors which may cause actual results, performance, or achievements to be materially different from those expressed or implied by such statements. Important factors that could cause such differences include, but are not limited to: risks that AI technologies may not produce expected results in drug discovery or development; risks related to the development, deployment, and performance of the Researgency platform; risks that the Company may not successfully attract or retain external platform clients; risks that the platform-as-a-service business model may not generate anticipated revenues; risks that the Company’s product candidates may not be successfully developed or commercialized; risks related to the Company’s limited cash resources and ability to continue as a going concern; risks that the third-party information contained herein was not accurate at the time it was published and/or does not accurately predict the future; risks related to the Company’s ability to raise future capital and the possibility that market conditions may limit the Company’s ability to raise capital on favorable terms; risks related to the Company’s ability to regain compliance with Nasdaq listing requirements; competition from larger, better-resourced companies including major technology and pharmaceutical companies; dependence on key personnel and third-party technology providers; the accuracy of third-party market forecasts and projections cited herein; risks that the Company may elect not to expand or continue its deployment of the Researgency platform beyond the initial term; risks that Younet may not perform its obligations under the Agreement; and other risks detailed in the “Risk Factors” section of the Company’s Annual Report on Form 10-K as they may be revised in the Company’s Quarterly Reports on Form 10-Q and Current Reports on Form 8-K and other filings with the Securities and Exchange Commission.

Forward-looking statements speak only as of the date of this release, and the Company undertakes no obligation to publicly update or revise any forward-looking statements, whether as a result of new information, future events, or otherwise, except as required by law.

Contact:

Avi Minkowitz
Chief Executive Officer, KALA BIO, Inc.
[email protected]
www.kalarx.com | www.Researgency.ai

120 mg and newly announced 60 mg once-daily doses each achieved ≥85% median hsCRP reductions in participants with obesity and elevated baseline inflammation

BGE-102 was well tolerated across all dose levels

Phase 2 proof-of-concept trial in cardiovascular risk planned to initiate mid-2026, with results anticipated by end of year

Phase 1b/2a proof-of-concept trial in diabetic macular edema (DME) planned to initiate mid-2026, with results anticipated mid-2027

BioAge to host conference call and webcast today at 8:00 AM ET to discuss BGE-102 results

EMERYVILLE, Calif., April 21, 2026 (GLOBE NEWSWIRE) — BioAge Labs, Inc. (Nasdaq: BIOA) (“BioAge” or the “Company”), a clinical-stage biopharmaceutical company developing therapeutic product candidates for metabolic diseases by targeting the biology of human aging, today reported results from the Phase 1 clinical trial of BGE-102, a potent, structurally novel, orally available, brain-penetrant small molecule NLRP3 inhibitor. The full dataset, which includes a newly announced 60 mg once-daily cohort dosed for 21 days in participants with obesity and elevated inflammation, demonstrates that BGE-102 achieved potential best-in-class reductions in high-sensitivity C-reactive protein (hsCRP) and consistent reductions across multiple inflammatory biomarkers, with a favorable tolerability profile.

Notably, the 60 mg dose achieved hsCRP and other biomarker reductions comparable to the previously reported 120 mg dose. Based on the full Phase 1 dataset, BioAge intends to initiate a dose-ranging Phase 2 cardiovascular risk proof-of-concept trial in the first half of 2026, with data anticipated in the second half of 2026.

“These Phase 1 results position BGE-102 as a potential best-in-class NLRP3 inhibitor, delivering profound hsCRP reductions with a well-tolerated once-daily oral dose,” said Kristen Fortney, Ph.D., CEO and co-founder of BioAge. “These data give us strong conviction to accelerate the program across multiple indications. BGE-102’s potency and tissue penetration make it a potential pipeline in a pill — a single oral therapy to address NLRP3-driven inflammation in cardiovascular, ocular, and CNS diseases. We are rapidly advancing BGE-102 with a Phase 2 dose-ranging trial in cardiovascular risk, a Ph1b/2a proof-of-concept trial in diabetic macular edema, and full investment in CMC, regulatory, and clinical activities to enable Phase 3 initiation in 2027.”

“hsCRP is among the most predictive biomarkers of cardiovascular risk, and targeting inflammation is a clinically validated strategy: prior interventional data for anti-inflammatory therapies demonstrated that reducing hsCRP below 2 mg/L was associated with a 25% reduction in major adverse cardiovascular events,” said Paul Rubin, M.D., Chief Medical Officer of BioAge. “We believe a convenient, well-tolerated oral medicine has broad potential in ASCVD secondary prevention — and potentially in primary prevention as well. These data, demonstrating potent effects across multiple clinically established drivers of cardiovascular risk, suggest that NLRP3 inhibition could have transformational potential, much as statins did for LDL cholesterol decades ago.”

Phase 1
Trial
Design

The Phase 1 trial was a randomized, double-blind, placebo-controlled trial in healthy volunteers and participants with obesity, with primary endpoints of pharmacokinetics and safety and exploratory pharmacodynamic endpoints including inflammatory biomarkers. The multiple ascending dose (MAD) portion of the study enrolled healthy volunteers and participants with obesity (BMI 32–42) with elevated systemic inflammation (hsCRP >3 mg/L). The two obese MAD cohorts are reported here: 120 mg once daily for 14 days and 60 mg once daily for 21 days. Prior results from single ascending dose (SAD) and MAD cohorts in healthy volunteers, including pharmacokinetics, brain penetration, and IL-1β suppression data, and additional results from the 120 mg obese MAD cohort, were reported previously.

Biomarker Efficacy in Participants with Obesity and Elevated hsCRP

hsCRP

BGE-102 demonstrated rapid, profound, and sustained reductions in hsCRP at both dose levels, with comparable percent median reductions from baseline:

• 60 mg QD (21-day dosing):
  • 85% reduction at Day 7, 80% at Day 14, 86% at Day 21
  • 87% of participants on active treatment (13/15) achieved normalized hsCRP (<2 mg/L) at Day 21, with 60% (9/15) reaching ≤1 mg/L
• 120 mg QD (14-day dosing):
  • 83% reduction at Day 7, 86% at Day 14
  • 93% of participants on active treatment (13/14) achieved normalized hsCRP (<2 mg/L) at Day 14, with 71% (10/14) reaching ≤1 mg/L

IL-6

Reductions in IL-6, a clinically validated inflammatory mediator of cardiovascular risk, were consistent with hsCRP findings at both dose levels, confirming potent upstream NLRP3 inflammasome inhibition:

• 60 mg QD: 78% reduction at Day 7, 70% at Day 14, 55% at Day 21
• 120 mg QD: 69% reduction at Day 7, 58% at Day 14

Fibrinogen

Reductions in fibrinogen, an established cardiovascular risk marker, were observed at both dose levels:

• 60 mg QD: 20% reduction at Day 7, 19% at Day 14, 23% at Day 21
• 120 mg QD: 24% reduction at Day 7, 30% at Day 14

Additional data from the BGE-102 Phase 1 trial are available in the Company’s corporate presentation, which can be found on the Investors section of the Company’s website.

Safety and Tolerability

BGE-102 was well tolerated across all dose levels evaluated in the Phase 1 study. All treatment-emergent adverse events (TEAEs) were mild to moderate in severity and self-limited, with no dose dependency. There were no serious adverse events, TEAEs leading to discontinuation, or clinically meaningful changes in vital signs, ECGs, or laboratory values.

BGE-102 Planned Development Program

Cardiovascular risk proof-of-concept trial

Based on the complete Phase 1 dataset, BioAge plans to initiate a Phase 2 dose-ranging proof-of-concept trial evaluating BGE-102 in participants at elevated cardiovascular risk in the first half of 2026, with data anticipated in the second half of 2026. Three oral once-daily dose levels will be assessed, with hsCRP as the primary endpoint. The trial is designed to support optimal dose selection for Phase 3. Additional trial design details are available in the Company’s corporate presentation.

Proof-of-concept trial in diabetic macular edema (DME)

BioAge also plans to initiate a Phase 1b/2a proof-of-concept study evaluating BGE-102 in patients with DME in mid-2026, with results anticipated in mid-2027. The trial is designed to demonstrate pharmacodynamic target engagement for BGE-102 in the eye, supporting future development in inflammation-driven retinal diseases. Additional details on the ophthalmology program can be found in the corporate presentation.

Conference Call and Webcast

BioAge management will host a conference call and webcast to review the Phase 1 results at 8:00 AM ET, April 21, 2026. Registration information is available here.

About BGE-102 and NLRP3

BGE-102 is a structurally novel, potent, orally available, brain-penetrant small molecule NLRP3 inhibitor discovered by BioAge. NLRP3 is a central driver of age-related chronic inflammation that has been implicated in cardiovascular disease, metabolic disorders including obesity, and neurodegenerative conditions. BioAge’s discovery platform identified NLRP3 as a therapeutic target based on analysis of human aging cohorts, which revealed that reduced NLRP3 activity is associated with greater longevity.

About BioAge Labs, Inc.

BioAge is a clinical-stage biopharmaceutical company developing therapeutic product candidates for metabolic diseases by targeting the biology of human aging. The Company’s lead product candidate, BGE-102, is a potent, orally available, brain-penetrant small-molecule NLRP3 inhibitor being developed for cardiovascular risk and retinal diseases including diabetic macular edema. BGE-102 has completed a Phase 1 SAD/MAD trial demonstrating a well-tolerated profile and potential best-in-class reductions in hsCRP and other inflammatory biomarkers in participants with obesity and elevated inflammation. Phase 2 cardiovascular risk proof-of-concept data are anticipated in H2 2026, and Phase 1b/2a diabetic macular edema proof-of-concept data are anticipated in mid 2027. The Company is also developing long-acting injectable and oral small molecule APJ agonists for obesity. BioAge’s additional preclinical programs, which leverage insights from the Company’s proprietary discovery platform built on human longevity data, address key pathways involved in metabolic aging.

Forward-looking statements

This press release contains “forward-looking statements” within the meaning of, and made pursuant to the safe harbor provisions of, the Private Securities Litigation Reform Act of 1995. All statements contained in this press release that do not relate to matters of historical fact should be considered forward-looking statements, including, but not limited to, statements regarding our plans to develop and commercialize our product candidates, including BGE-102, the potential for BGE-102 as a treatment for cardiovascular diseases and retinal diseases including diabetic macular edema, the expected timing of clinical trials, the timing and results of our clinical activities, risks associated with clinical trials, including our ability to adequately manage clinical activities, the timing of and our ability to obtain and maintain regulatory approvals and the clinical utility of our product candidates. These forward-looking statements may be accompanied by such words as “aim,” “anticipate,” “believe,” “could,” “estimate,” “expect,” “forecast,” “goal,” “intend,” “may,” “might,” “plan,” “potential,” “possible,” “will,” “would,” and other words and terms of similar meaning. These statements involve risks and uncertainties that could cause actual results to differ materially from those reflected in such statements, including: our ability to develop, obtain regulatory approval for and commercialize our product candidates; the timing and results of preclinical studies and clinical trials; the risk that positive results in a preclinical study or clinical trial may not be replicated in subsequent trials or success in early stage clinical trials may not be predictive of results in later stage clinical trials; risks associated with clinical trials, including our ability to adequately manage clinical activities, unexpected concerns that may arise from additional data or analysis obtained during clinical trials, regulatory authorities may require additional information or further studies, or may fail to approve or may delay approval of our drug candidates; the occurrence of adverse safety events; failure to protect and enforce our intellectual property, and other proprietary rights; failure to successfully execute or realize the anticipated benefits of our strategic and growth initiatives; risks relating to technology failures or breaches; our dependence on collaborators and other third parties for the development of product candidates and other aspects of our business, which are outside of our full control; risks associated with current and potential delays, work stoppages, or supply chain disruptions, including due to the imposition of tariffs and other trade barriers; risks associated with current and potential future healthcare reforms; risks relating to attracting and retaining key personnel; changes in or failure to comply with legal and regulatory requirements, including shifting priorities within the U.S. Food and Drug Administration; risks relating to access to capital and credit markets; and the other risks and uncertainties that are detailed under the heading “Risk Factors” included in BioAge’s Annual Report on Form 10-K filed with the U.S. Securities and Exchange Commission (SEC) on March 24, 2026, and BioAge’s other filings with the SEC filed from time to time. BioAge undertakes no obligation to publicly update any forward-looking statement, whether written or oral, that may be made from time to time, whether as a result of new information, future developments or otherwise.

Contacts

PR: Chris Patil, [email protected]
IR: Dov Goldstein, [email protected]
Partnering: Peng Leong, [email protected]
Web: https://bioagelabs.com

• This is the first release of 36-week symptom response & tissue health data for the highest dose (Cohort 9) from the dose escalation portion of Eupraxia’s RESOLVE trial. 
• At 36 weeks, patients in Cohort 9 (n=3) demonstrated a robust response in both tissue health and symptom response compared to their baseline levels.
• Patients in Cohort 9 also demonstrated the highest response in tissue health at week 36 compared to all other dose cohorts in the RESOLVE trial.
• Clinical remission in symptoms was maintained in 66% of the patients (2 of 3) in Cohort 9 at week 36. This level of remission was first achieved at week 8 and was maintained through 36 weeks.
• EP-104GI continues to be well tolerated by patients receiving the drug; 31 patients have been treated in the Phase 1b/2a study and over 230 patient-months of follow-up have been reported with no drug related Serious Adverse Events (“SAEs”). There still have been no cases of oropharyngeal candidiasis, a commonly reported adverse event with the oral delivery of steroids.

VANCOUVER, British Columbia, April 21, 2026 (GLOBE NEWSWIRE) — Eupraxia Pharmaceuticals Inc. (“Eupraxia” or the “Company”) (NASDAQ:EPRX) (TSX:EPRX), a clinical-stage biotechnology company leveraging its proprietary Diffusphere™ technology designed to optimize local, controlled drug delivery for applications with significant unmet need, today announced 36-week tissue health and symptom data from patients in the highest dose cohort from its ongoing Phase 1b/2a part of the RESOLVE trial evaluating EP-104GI for the treatment of eosinophilic esophagitis (“EoE”).

“We are very pleased with the robust and sustained response in both tissue health and symptom data in the highest dose cohort at 36 weeks,” said Dr. James A. Helliwell, Chief Executive Officer of Eupraxia. “This data is consistent with the compelling results we observed at earlier timepoints at this dose level, highlighting the potential to achieve both strong and durable responses after a single administration of EP-104GI. We are also reassured by the excellent safety outcomes across all doses in the trial as we continue to observe no indication of drug related SAEs or spikes in glucose or cortisol. We look forward to the results of the placebo-controlled Phase 2b portion of the study where the same dose is being further evaluated”.

Key New Findings from the RESOLVE Trial

Tissue Health Outcomes as Measured by EoEHSS and PEC

• In Cohort 9 (20 x 8 mg dose) the EoEHSS Stage and Grade reductions at week 36 were 0.59 and 0.53, representing a 90% and 88% reduction, respectively.
• Notably, improvements were seen across both inflammatory and architectural (i.e. structural) components that comprise the EoEHSS score, suggesting improvements in both inflammatory and fibrotic histologic aspects of the disease.
• Also in Cohort 9 at week 36, there was a 72% reduction in Peak Eosinophil Count (PEC) from baseline. Compared to all other dose cohorts, this was the largest reduction in PEC.

Clinical Remission and Symptom Response as Measured by SDI

• In Cohort 9, at week 36 there was an average reduction compared to baseline in the Straumann Dysphagia Index (SDI) of 3 points (a 3-point reduction is defined as clinical remission).
• In total, 2 of 3 patients maintained clinical remission from weeks 8 to 36, representing a 66% clinical remission response rate.

Safety and Tolerability

• To date, over 230 patient-months of follow-up have been reported across 31 patients in all cohorts.
• No drug related SAEs have been reported.
• No cases of oropharyngeal candidiasis, a commonly reported adverse event associated with the use of swallowed steroids, have been reported.
• No cases of adrenal insufficiency or glucose derangement, including in the single patient with type II diabetes.
• EP-104GI has been generally well tolerated at all dose levels, including the highest dose of 8 mg/site at 20 injection sites (Cohort 9).

An updated summary of the above and previously announced clinical trial results are posted in the Investor Section of the Eupraxia Pharmaceuticals website and can be found here.

About the RESOLVE Trial 

The Phase 1b/2a part of the RESOLVE trial is a multicenter, open-label, dose-escalation study evaluating the safety, tolerability, pharmacokinetics, and efficacy of EP-104GI in adults with histologically confirmed active EoE. The treatment is administered as a single dose via 4 to 20 esophageal wall injections, with dose escalations modifying either the dose per site and/or the number of sites. Participants were followed for up to 24 weeks in Cohorts 1-4 (4x1mg, 8x1mg, 8×2.5mg and 12×2.5mg) or 52 weeks in Cohorts 5-9 (12x4mg, 16x4mg, 20x4mg, 20x6mg and 20x8mg). Eupraxia plans to disclose additional data from the open-label Phase 1b/2a part of the RESOLVE trial in the coming months.

The Phase 2b part of RESOLVE trial, a randomized placebo-controlled study of EP-104GI, is currently recruiting both the 120mg (20x6mg) and 160mg (20x8mg) doses. The top-line data from the Phase 2b part of the RESOLVE trial is expected in Q4 2026. 

Notes 

1. Clinical remission is defined as a reduction of at least 3 points on the SDI scale. Achieving clinical remission is a positive outcome for the RESOLVE trial. 
2. SDI is a patient-reported outcome score that uses a seven-day recall measuring dysphagia (trouble swallowing) severity and frequency. A reduction in SDI is a positive outcome for the RESOLVE trial. 

About Eosinophilic Esophagitis (EoE) 
EoE is an inflammatory-mediated disease in which white blood cells migrate into and become trapped in the esophagus, creating pain and difficulty with swallowing food. According to market research from Clearview Healthcare Partners, EoE affects more than 450,000 people in the United States and has been identified by the American Gastroenterological Association as rapidly increasing in both incidence and prevalence. Impacts from both symptoms and interventions frequently lead to mental health issues, compounding the disease burden of EoE for both the healthcare system and the individual. 

About Eupraxia Pharmaceuticals Inc. 

Eupraxia is a clinical-stage biotechnology company focused on the development of locally delivered, extended-release products that have the potential to address therapeutic areas with high unmet medical need. Diffusphere™, a proprietary, polymer-based micro-sphere technology, is designed to facilitate targeted drug delivery of both existing and novel drugs. The technology is designed to support extended duration of effect and delivery of drugs in a hyper-localized fashion, targeting only the tissues that physicians are wanting to treat. We believe the potential for fewer adverse events may be achieved through the precision targeting and the stable and flat delivery of the active ingredient when using the Diffusphere™ technology, versus the peaks and troughs seen with more traditional drug delivery methods. The precision of Eupraxia’s Diffusphere™ technology platform has the potential to augment and transform existing FDA-approved drugs to improve their safety, tolerability, efficacy and duration of effect. The potential uses in therapeutic areas may go beyond pain and inflammatory gastrointestinal disease, where Eupraxia currently is developing advanced treatments, to also be applicable in oncology, infectious disease and other critical disease areas.

Eupraxia’s EP-104GI is currently in a Phase 1b/2 trial, the RESOLVE trial, for the treatment of EoE. EP-104GI is administered as an injection into the esophageal wall, providing local delivery of drug. This is a unique treatment approach for EoE. Eupraxia also completed a Phase 2b clinical trial (SPRINGBOARD) of EP-104IAR for the treatment of pain due to knee osteoarthritis. The trial met its primary endpoint and three of the four secondary endpoints. In addition, Eupraxia is developing a pipeline of later and earlier-stage long-acting formulations. Potential pipeline indications include candidates for other inflammatory joint indications and oncology, each designed to improve on the activity and tolerability of currently approved drugs. For further details about Eupraxia, please visit the Company’s website at: www.eupraxiapharma.com.

Notice Regarding Forward-looking Statements and Information 

This news release includes forward-looking statements and forward-looking information within the meaning of applicable securities laws. Often, but not always, forward-looking information can be identified by the use of words such as “plans”, “is expected”, “expects”, “suggests”, “indicates”, “scheduled”, “intends”, “contemplates”, “anticipates”, “believes”, “proposes”, “potential” or variations (including negative and grammatical variations) of such words and phrases, or statements that certain actions, events or results “may”, “could”, “would”, “might” or “will” be taken, occur or be achieved. Forward-looking statements in this news release include statements regarding the interpretation of the 36-week data from the RESOLVE trial, including tissue health and symptom response; the Company’s expected timing of reporting additional data from the RESOLVE trial, including the Phase 2b portion thereof; the Company’s product candidates, including their expected benefits with respect to safety, tolerability, efficacy and duration of effect and their potential use in therapeutic areas beyond pain and inflammatory gastrointestinal disease; the expectations regarding the advancement of the Company’s product candidates through clinical development; the results of clinical trials of the Company’s product candidates; the potential for the Company’s technology to impact the drug delivery process; the potential market opportunity for the Company’s product candidates; and potential pipeline indications. Such statements and information are based on the current expectations of Eupraxia’s management, and are based on assumptions, including but not limited to: future research and development plans for the Company proceeding substantially as currently envisioned; industry growth trends, including with respect to projected and actual industry sales; the Company’s ability to obtain positive results from the Company’s research and development activities, including clinical trials; and the Company’s ability to protect patents and proprietary rights. Although Eupraxia’s management believes that the assumptions underlying these statements and information are reasonable, they may prove to be incorrect. The forward-looking events and circumstances discussed in this news release may not occur by certain dates or at all and could differ materially as a result of known and unknown risk factors and uncertainties affecting Eupraxia, including, but not limited to: risks and uncertainties related to the Company’s limited operating history; the Company’s novel technology with uncertain market acceptance; if the Company breaches any of the agreements under which it licenses rights to its product candidates or technology from third parties, the possibility that the Company could lose license rights that are important to its business; the Company’s current license agreement may not provide an adequate remedy for its breach by the licensor; the possibility that the Company’s technology may not be successful for its intended use; the fact that the Company’s future technology will require regulatory approval, which is costly and the Company may not be able to obtain it; the possibility that the Company may fail to obtain regulatory approvals or only obtain approvals for limited uses or indications; the possibility that the Company’s clinical trials may fail to demonstrate adequately the safety and efficacy of its product candidates at any stage of clinical development; the possibility that the Company may be required to suspend or discontinue clinical trials due to side effects or other safety risks; the fact that the Company completely relies on third parties to provide supplies and inputs required for its product candidates and services; the potential impact of tariffs on the cost of the Company’s active pharmaceutical ingredients and clinical supplies of EP-104IAR and EP-104GI; the fact that the Company relies on external contract research organizations to provide clinical and non-clinical research services; the possibility that the Company may not be able to successfully execute its business strategy; the fact that the Company will require additional financing, which may not be available; the fact that any therapeutics the Company develops will be subject to extensive, lengthy and uncertain regulatory requirements, which could adversely affect the Company’s ability to obtain regulatory approval in a timely manner, or at all; the impact of health pandemics or epidemics on the Company’s operations; the Company’s restatement of its consolidated financial statements, which may lead to additional risks and uncertainties, including loss of investor confidence and negative impacts on the Company’s common share price; and other risks and uncertainties described in more detail in Eupraxia’s public filings on SEDAR+ (sedarplus.ca) and EDGAR (sec.gov). Although Eupraxia has attempted to identify important factors that could cause actual actions, events or results to differ materially from those described in forward-looking statements and information, there may be other factors that cause actions, events or results to differ from those anticipated, estimated or intended. No forward-looking statement or information can be guaranteed. Except as required by applicable securities laws, forward-looking statements and information speak only as of the date on which they are made and Eupraxia undertakes no obligation to publicly update or revise any forward-looking statement or information, whether as a result of new information, future events or otherwise.   

For investor and media inquiries, please contact: 

James Meikle, Eupraxia Pharmaceuticals Inc. 
236-330-7084 
[email protected] 

or 

Kevin Gardner, on behalf of: 
Eupraxia Pharmaceuticals Inc. 
617-283-2856 
[email protected] 

SOURCE Eupraxia Pharmaceuticals Inc. 

Ongoing production scale orders from U.S. Tier-1 customer accelerate as drones are delivered under a $249 million Program of Record   

Deliveries have already commenced and are expected to conclude well within 2026

Palo Alto, California, April 21, 2026 (GLOBE NEWSWIRE) — Mobilicom Limited (Nasdaq: MOB, MOBBW) (“Mobilicom” or the “Company”), a provider of cybersecurity and robust solutions for drones and robotics, today announced that it has received new purchase orders valued at $2.2 million from a large manufacturer of small-sized drones in the U.S. This large defense manufacturer customer, with over $5 billion in annual sales, integrated Mobilicom’s SkyHopper PRO and ICE Electronic Warfare Resistance & Cybersecurity Suite as essential systems into its loitering munitions drones sold to the U.S. Department of War (DoW) under a Program of Record valued at $249 million. Shipments against the recent purchase orders have commenced and will continue into 2026 with full delivery expected before the end of the year.

This latest $2.2 million order marks a significant increase in the Company’s engagement with this customer, building on a prior $1.5 million order and a series of initial orders of approximately $200,000 each — all under a single program. The trajectory underscores the expanding adoption and growing operational reliance on Mobilicom’s solutions.

“The Program of Record win by our Tier-1 customer marks a major inflection point for Mobilicom as we receive increasingly larger sized orders at an accelerating pace,” stated the Founder and CEO of Mobilicom, Oren Elkayam. “As our embedded SkyHopper PRO datalinks and ICE Cybersecurity are the backbone powering these mission-critical drones, we are well positioned to benefit from further accelerating production and rising order volumes over the coming years. With secured, multi-year Program of Record funding and growing global demand for loitering munitions, this milestone strengthens our incumbency advantage and reinforces our role in supporting long-term U.S. and allied defense programs.”

About Mobilicom

Mobilicom is a leading provider of cybersecure robust solutions for the rapidly growing defense and commercial drones and robotics market. Mobilicom’s large portfolio of field-proven technologies includes cybersecurity, software, hardware, and professional services that power, connect, guide, and secure drones and robotics. Through deployments across the globe with over 50 customers, including the world’s largest drone manufacturers, Mobilicom’s end-to-end solutions are used in mission-critical functions.

For investors, please use https://ir.mobilicom.com/  
For company, please use www.mobilicom.com

Forward Looking Statements

This press release contains “forward-looking statements” that are subject to substantial risks and uncertainties. For example, the Company is using forward-looking statements when it discusses that it is well positioned to benefit from further accelerating production and rising order volumes over the coming years. All statements, other than statements of historical fact, contained in this press release are forward-looking statements. Forward-looking statements contained in this press release may be identified by the use of words such as “anticipate,” “believe,” “contemplate,” “could,” “estimate,” “expect,” “intend,” “seek,” “may,” “might,” “plan,” “potential,” “predict,” “project,” “target,” “aim,” “should,” “will” “would,” or the negative of these words or other similar expressions, although not all forward-looking statements contain these words. Forward-looking statements are based on Mobilicom Limited’s current expectations and are subject to inherent uncertainties, risks and assumptions that are difficult to predict. Further, certain forward-looking statements are based on assumptions as to future events that may not prove to be accurate. These and other risks and uncertainties are described more fully in the Company’s filings with the Securities and Exchange Commission.

Forward-looking statements contained in this announcement are made as of this date, and Mobilicom Limited undertakes no duty to update such information except as required under applicable law.

For more information on Mobilicom, please contact:

Liad Gelfer

Mobilicom Ltd
[email protected]