Eupraxia Pharmaceuticals Announces Positive Data from Highest-Dose Cohort in the Ongoing RESOLVE Trial in Eosinophilic Esophagitis, and Plans for Expansion of EP-104GI Development Programs




Eupraxia Pharmaceuticals Announces Positive Data from Highest-Dose Cohort in the Ongoing RESOLVE Trial in Eosinophilic Esophagitis, and Plans for Expansion of EP-104GI Development Programs

• Clinical data was reported for the first time in patients receiving an 8 mg dose per injection (Cohort 9 of the dose escalation portion of RESOLVE), the highest dose planned in this trial.

• Patients in Cohort 9 experienced the largest improvements in tissue health outcomes and eosinophil reduction observed to date.
• RESOLVE Safety Committee and members of the Eupraxia Clinical Advisory Board endorsed using the 8 mg dose per injection as the second dose for the ongoing Phase 2b portion of the RESOLVE study.
• Eupraxia intends to expand the EP-104GI development program, including increasing the number of patients in the Phase 2b portion of RESOLVE from 60 to at least 120 patients.
• Eupraxia intends to initiate a clinical trial for an additional market-expanding GI indication in the first half of 2026.
• Eupraxia will host a webinar on October 1^st at 8am PDT to provide additional information. The live webinar is available at: https://lifescievents.com/event/fk30t7wg2n/

VICTORIA, British Columbia, Sept. 29, 2025 (GLOBE NEWSWIRE) — Eupraxia Pharmaceuticals Inc. (“Eupraxia” or the “Company”) (NASDAQ:EPRX) (TSX:EPRX), a clinical-stage biotechnology company leveraging its proprietary Diffusphere™ technology to optimize local, controlled drug delivery for diseases with significant unmet need, today provided an operational update on the development of EP-104GI, including reporting data from patients in Cohort 9 of the dose escalation portion of the RESOLVE trial, the first time that patients received an 8mg dose per injection.

“We believe our recent financing, combined with our latest clinical trial results, underscores both the medical and investment communities’ confidence in EP-104GI. The strong efficacy trend observed in previous cohorts – the more drug we deliver to the tissue, the better the results we observe – has continued in Cohort 9. Combined with the absence of any Serious Adverse Events or cases of candidiasis, this strongly suggests that an 8mg dose per injection is the optimal second dose to test in our Phase 2b trial”, said Dr. James A. Helliwell, Chief Executive Officer of Eupraxia. “We believe EP-104GI has the potential to significantly improve upon the current standard of care, as the clinical efficacy outcomes and improvements in tissue health reported so far are well beyond the published results for the leading currently approved therapies. With the capital raised, we are well-positioned to expand our Phase 2 study, prepare for a robust Phase 3 program, and pursue additional clinical indications, subject to discussions with FDA, all with a runway extending well into 2028”.

Key Findings from the 8mg Per Injection Dose Group in the Dose Escalation Portion of the RESOLVE Trial

The corporate presentation on the Company’s website has been updated to reflect the additional data described below.

• Clinical Remission¹: Rapid and meaningful induction of clinical remission observed as measured by the Straumann Dysphagia Index (“SDI”)²
• Tissue Health and Eosinophil Reduction: Greatest improvements to date in EoEHSS (Eosinophilic Esophagitis Histological Scoring System) scores, with the greatest percentage of biopsy sites in remission (≤6 eos/hpf)³
• Correlation to Outcomes: Across all cohorts, when more drug is delivered into the tissue, greater disease resolution and eosinophil reduction is observed
• Durability: Long-term data continues to show patients maintaining clinical benefit, tissue health, and tolerability
• Safety Outcomes: Zero SAEs and zero cases of candidiasis reported across all patients, including those at the 8mg per injection dose

Key Changes to The Phase 2b RESOLVE Trial

• Based on the positive safety and efficacy results from Cohort 9 in the open-label dose escalation (Phase 1b/2a study), Eupraxia expects to select the 8 mg/per injection & 20 injections per administration (for a total for 160 mg per patient) as the second active dose level for the Phase 2b portion of the RESOLVE trial. The dose level has been cleared by the RESOLVE Safety Committee and endorsed by members of the Eupraxia Clinical Advisory Board.
• Eupraxia intends to increase the size of the Phase 2b portion of the RESOLVE Trial to a minimum of 40 patients per dose group. The total number of patients enrolled is expected to increase from 60 to at least 120.
• The increase in size of the Phase 2b trial will provide the following benefits:
  • Greater statistical power to the primary and all key secondary endpoints
  • Larger safety database
  • Improved potential of obtaining breakthrough status
  • Higher probability of needing to perform only a single Phase 3 pivotal trial
  • Improved ability to select an optimized dose for Phase 3 for safety, efficacy and durability

Expanded Plans for EP-104GI and Other New Drug Candidate(s)

In addition to increasing the size of the RESOLVE study, Eupraxia intends to use proceeds from the recent financing to expand the non-clinical and clinical program for EP-104GI, subject to discussions with FDA, with the aim of increasing the future market size of the program. This includes:

• Development of additional indications for EP-104GI in the GI field; the Company plans to dose first patients in the first half of 2026.
• The Company is currently considering indications where localized treatment would provide maximum benefit such as fibrostenotic Crohn’s, treatment of benign esophageal strictures, and the prevention of strictures in Barrett’s esophagus.
• Completion of non-clinical work to enable repeat dosing and inclusion of adolescent patients in the Phase 3 program.
• Development work of applications for Diffusphere™ with other Active Pharmaceutical Ingredients (APIs) other than fluticasone propionate

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 (4x1mg, 8x1mg, 8×2.5mg and 12×2.5mg) or 52 weeks (12x4mg and subsequent ongoing dose levels). Eupraxia plans to disclose additional data from the open-label Phase 1b/2a part of the RESOLVE trial in Q4 2025.

The Phase 2b part of the RESOLVE trial, a randomized placebo-controlled study of EP-104GI, is currently recruiting with the first clinical dose of 120mg (20 x 6mg). The top-line data from the Phase 2b part of the RESOLVE trial is expected in Q3 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.
3. In the EoEHSS, grade indicates the severity of each of the eight histologic features assessed by the EoEHSS while stage indicates their extent. For the RESOLVE trial, these features include inflammation, increased cell production in a normal tissue or organ, and fibrosis, also known as fibrotic scarring, and five other features. A reduction in EoEHSS 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 recently 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”, “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 Company’s expected timing of reporting additional data from the RESOLVE trial in Q4 2025; the Company’s product candidates, including their expected benefits to patients with respect to safety, tolerability, efficacy and duration; the expectations around proceeding to clinical trials for the Company’s product candidates; the results gathered from studies and trials of Eupraxia’s product candidates and the expected timing thereof; the Company’s plans to expand the EP-104GI developmental program, including the increase in the number of patients in the Phase 2b portion of RESOLVE and dosing level to be selected, and the timing and expected benefits thereof; the potential for the Company’s technology to impact the drug delivery process; the expected use of proceeds of the Company’s recent financing; 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 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 Company’s technology may not be successful for its intended use; the Company’s future technology will require regulatory approval, which is costly and the Company may not be able to obtain it; the Company may fail to obtain regulatory approvals or only obtain approvals for limited uses or indications; 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 Company may be required to suspend or discontinue clinical trials due to side effects or other safety risks; 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 Company relies on external contract research organizations to provide clinical and non-clinical research services; the Company may not be able to successfully execute its business strategy; the Company will require additional financing, which may not be available; 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:

Danielle Egan, Eupraxia Pharmaceuticals Inc.
778.401.3302
degan@eupraxiapharma.com

or

Kevin Gardner, on behalf of:
Eupraxia Pharmaceuticals Inc.
617.283.2856
kgardner@lifesciadvisors.com

SOURCE Eupraxia Pharmaceuticals Inc.

Eupraxia Pharmaceuticals Announces Positive Data from Highest-Dose Cohort in the Ongoing RESOLVE Trial in Eosinophilic Esophagitis, and Plans for Expansion of EP-104GI Development Programs




Eupraxia Pharmaceuticals Announces Positive Data from Highest-Dose Cohort in the Ongoing RESOLVE Trial in Eosinophilic Esophagitis, and Plans for Expansion of EP-104GI Development Programs

• Clinical data was reported for the first time in patients receiving an 8 mg dose per injection (Cohort 9 of the dose escalation portion of RESOLVE), the highest dose planned in this trial.

• Patients in Cohort 9 experienced the largest improvements in tissue health outcomes and eosinophil reduction observed to date.
• RESOLVE Safety Committee and members of the Eupraxia Clinical Advisory Board endorsed using the 8 mg dose per injection as the second dose for the ongoing Phase 2b portion of the RESOLVE study.
• Eupraxia intends to expand the EP-104GI development program, including increasing the number of patients in the Phase 2b portion of RESOLVE from 60 to at least 120 patients.
• Eupraxia intends to initiate a clinical trial for an additional market-expanding GI indication in the first half of 2026.
• Eupraxia will host a webinar on October 1^st at 8am PDT to provide additional information. The live webinar is available at: https://lifescievents.com/event/fk30t7wg2n/

VICTORIA, British Columbia, Sept. 29, 2025 (GLOBE NEWSWIRE) — Eupraxia Pharmaceuticals Inc. (“Eupraxia” or the “Company”) (NASDAQ:EPRX) (TSX:EPRX), a clinical-stage biotechnology company leveraging its proprietary Diffusphere™ technology to optimize local, controlled drug delivery for diseases with significant unmet need, today provided an operational update on the development of EP-104GI, including reporting data from patients in Cohort 9 of the dose escalation portion of the RESOLVE trial, the first time that patients received an 8mg dose per injection.

“We believe our recent financing, combined with our latest clinical trial results, underscores both the medical and investment communities’ confidence in EP-104GI. The strong efficacy trend observed in previous cohorts – the more drug we deliver to the tissue, the better the results we observe – has continued in Cohort 9. Combined with the absence of any Serious Adverse Events or cases of candidiasis, this strongly suggests that an 8mg dose per injection is the optimal second dose to test in our Phase 2b trial”, said Dr. James A. Helliwell, Chief Executive Officer of Eupraxia. “We believe EP-104GI has the potential to significantly improve upon the current standard of care, as the clinical efficacy outcomes and improvements in tissue health reported so far are well beyond the published results for the leading currently approved therapies. With the capital raised, we are well-positioned to expand our Phase 2 study, prepare for a robust Phase 3 program, and pursue additional clinical indications, subject to discussions with FDA, all with a runway extending well into 2028”.

Key Findings from the 8mg Per Injection Dose Group in the Dose Escalation Portion of the RESOLVE Trial

The corporate presentation on the Company’s website has been updated to reflect the additional data described below.

• Clinical Remission¹: Rapid and meaningful induction of clinical remission observed as measured by the Straumann Dysphagia Index (“SDI”)²
• Tissue Health and Eosinophil Reduction: Greatest improvements to date in EoEHSS (Eosinophilic Esophagitis Histological Scoring System) scores, with the greatest percentage of biopsy sites in remission (≤6 eos/hpf)³
• Correlation to Outcomes: Across all cohorts, when more drug is delivered into the tissue, greater disease resolution and eosinophil reduction is observed
• Durability: Long-term data continues to show patients maintaining clinical benefit, tissue health, and tolerability
• Safety Outcomes: Zero SAEs and zero cases of candidiasis reported across all patients, including those at the 8mg per injection dose

Key Changes to The Phase 2b RESOLVE Trial

• Based on the positive safety and efficacy results from Cohort 9 in the open-label dose escalation (Phase 1b/2a study), Eupraxia expects to select the 8 mg/per injection & 20 injections per administration (for a total for 160 mg per patient) as the second active dose level for the Phase 2b portion of the RESOLVE trial. The dose level has been cleared by the RESOLVE Safety Committee and endorsed by members of the Eupraxia Clinical Advisory Board.
• Eupraxia intends to increase the size of the Phase 2b portion of the RESOLVE Trial to a minimum of 40 patients per dose group. The total number of patients enrolled is expected to increase from 60 to at least 120.
• The increase in size of the Phase 2b trial will provide the following benefits:
  • Greater statistical power to the primary and all key secondary endpoints
  • Larger safety database
  • Improved potential of obtaining breakthrough status
  • Higher probability of needing to perform only a single Phase 3 pivotal trial
  • Improved ability to select an optimized dose for Phase 3 for safety, efficacy and durability

Expanded Plans for EP-104GI and Other New Drug Candidate(s)

In addition to increasing the size of the RESOLVE study, Eupraxia intends to use proceeds from the recent financing to expand the non-clinical and clinical program for EP-104GI, subject to discussions with FDA, with the aim of increasing the future market size of the program. This includes:

• Development of additional indications for EP-104GI in the GI field; the Company plans to dose first patients in the first half of 2026.
• The Company is currently considering indications where localized treatment would provide maximum benefit such as fibrostenotic Crohn’s, treatment of benign esophageal strictures, and the prevention of strictures in Barrett’s esophagus.
• Completion of non-clinical work to enable repeat dosing and inclusion of adolescent patients in the Phase 3 program.
• Development work of applications for Diffusphere™ with other Active Pharmaceutical Ingredients (APIs) other than fluticasone propionate

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 (4x1mg, 8x1mg, 8×2.5mg and 12×2.5mg) or 52 weeks (12x4mg and subsequent ongoing dose levels). Eupraxia plans to disclose additional data from the open-label Phase 1b/2a part of the RESOLVE trial in Q4 2025.

The Phase 2b part of the RESOLVE trial, a randomized placebo-controlled study of EP-104GI, is currently recruiting with the first clinical dose of 120mg (20 x 6mg). The top-line data from the Phase 2b part of the RESOLVE trial is expected in Q3 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.
3. In the EoEHSS, grade indicates the severity of each of the eight histologic features assessed by the EoEHSS while stage indicates their extent. For the RESOLVE trial, these features include inflammation, increased cell production in a normal tissue or organ, and fibrosis, also known as fibrotic scarring, and five other features. A reduction in EoEHSS 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 recently 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”, “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 Company’s expected timing of reporting additional data from the RESOLVE trial in Q4 2025; the Company’s product candidates, including their expected benefits to patients with respect to safety, tolerability, efficacy and duration; the expectations around proceeding to clinical trials for the Company’s product candidates; the results gathered from studies and trials of Eupraxia’s product candidates and the expected timing thereof; the Company’s plans to expand the EP-104GI developmental program, including the increase in the number of patients in the Phase 2b portion of RESOLVE and dosing level to be selected, and the timing and expected benefits thereof; the potential for the Company’s technology to impact the drug delivery process; the expected use of proceeds of the Company’s recent financing; 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 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 Company’s technology may not be successful for its intended use; the Company’s future technology will require regulatory approval, which is costly and the Company may not be able to obtain it; the Company may fail to obtain regulatory approvals or only obtain approvals for limited uses or indications; 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 Company may be required to suspend or discontinue clinical trials due to side effects or other safety risks; 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 Company relies on external contract research organizations to provide clinical and non-clinical research services; the Company may not be able to successfully execute its business strategy; the Company will require additional financing, which may not be available; 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:

Danielle Egan, Eupraxia Pharmaceuticals Inc.
778.401.3302
degan@eupraxiapharma.com

or

Kevin Gardner, on behalf of:
Eupraxia Pharmaceuticals Inc.
617.283.2856
kgardner@lifesciadvisors.com

SOURCE Eupraxia Pharmaceuticals Inc.

Neuphoria Provides Fiscal Year-End 2025 Financial Results and Business Updates




Neuphoria Provides Fiscal Year-End 2025 Financial Results and Business Updates

Last patient last visit (LPLV) milestone in AFFIRM-1 Phase 3 trial of BNC-210 in social anxiety disorder (SAD) achieved; topline readout anticipated in early Q4 2025

Cash runway extended through fiscal Q2 2027

BURLINGTON, Mass., Sept. 29, 2025 (GLOBE NEWSWIRE) — Neuphoria Therapeutics Inc. (Nasdaq: NEUP) (“Neuphoria” or the “Company”), a clinical-stage biotechnology company developing impactful treatments for neuropsychiatric disorders, today reported its financial results for its fiscal year ended June 30, 2025, and provided recent business updates.

“It is an exciting time for Neuphoria as we rapidly approach topline data from our AFFIRM-1 Phase 3 study of BNC-210 in social anxiety disorder, which is anticipated early in the fourth quarter of this year,” said Spyros Papapetropoulos, M.D., Ph.D., President and CEO of Neuphoria. “BNC-210 is supported by a robust body of clinical data, demonstrating clinically meaningful effects across multiple stress and anxiety indications. These data, along with its differentiated safety profile, give us confidence in BNC-210 as a potentially transformative treatment for patients struggling with SAD.”

Clinical Program Highlights

• The LPLV milestone has been achieved in the AFFIRM-1 Phase 3 trial evaluating BNC-210 as a first-in-class, acute, “as needed” treatment for SAD. Topline data are anticipated in early fourth quarter 2025.
• Start-up activities continue for the SYMPHONY Phase 2b/3 trial in PTSD. Neuphoria plans to initiate the clinical study in the first half of 2026.
• MK-1167, one of two positive allosteric modulator (PAM) candidates being advanced in a strategic partnership with Merck & Co, Inc., is currently being evaluated in a Merck-led Phase 2 trial in Alzheimer’s disease.

June 30^th Fiscal Year-End 2025 Financial Results and Key Highlights

Cash Position: Cash and cash equivalents were $14.2 million as of June 30, 2025. The Company expects its current cash position to be sufficient to fund operations through the second fiscal quarter of 2027.

R&D Expenses: Research and development expenses were $9.0 million for the year ended June 30, 2025, compared to $9.4 million for the year ended June 30, 2024. The decrease of $0.4 million was primarily due to the timing of clinical and consulting related spend.

G&A Expenses: General and administrative expenses were $7.8 million for the year ended June 30, 2025, compared to $8.5 million for the year ended June 30, 2024. The decrease of $0.7 million was primarily due to decreases in headcount and insurance costs.

Net Loss: Net loss was $0.4 million, or $0.23 per basic and diluted share, for the year ended June 30, 2025, compared to a net loss of $15.5 million, or $18.62 per basic and diluted share, for the year ended June 30, 2024.

About BNC-210

BNC-210 is an oral, proprietary, selective negative allosteric modulator of the α7 nicotinic acetylcholine receptor under development for the treatment of SAD and post-traumatic stress disorder (PTSD). BNC-210 has been given FDA Fast Track designation for acute treatment of SAD and other anxiety related disorders, and for treatment of PTSD and other trauma and stressor related disorders. BNC-210 has demonstrated rapid-onset, broad and meaningful anti-anxiety effects in completed clinical trials in SAD, generalized anxiety disorder (GAD) and panic attacks without evidence of sedation, impairments in cognition or addiction potential.

About Neuphoria Therapeutics Inc.

Neuphoria (Nasdaq: NEUP) is a clinical-stage biotechnology company dedicated to developing therapies that address the complex needs of individuals affected by neuropsychiatric disorders. Neuphoria is advancing its lead drug candidate, BNC-210, an oral, proprietary, selective negative allosteric modulator of the α7 nicotinic acetylcholine receptor, for the acute, “as needed” treatment of social anxiety disorder (SAD) and for chronic treatment of post-traumatic stress disorder (PTSD). BNC-210 is a first-of-its-kind, well-tolerated, broad spectrum anti-anxiety experimental therapeutic, designed to restore neurotransmitter balance in relevant brain areas, providing rapid relief from stress and anxiety symptoms without the common pitfalls of sedation, cognitive impairment, or addiction. In addition, Neuphoria has a strategic partnership with Merck & Co., Inc. (known as MSD outside the United States and Canada) with two drugs in early-stage clinical trials for the treatment of cognitive deficits in Alzheimer’s disease and other central nervous system conditions. Neuphoria’s pipeline also includes the α7 nicotinic acetylcholine receptor next generation and the Kv3.1/3.2 preclinical programs, both in the lead optimization development stage.

Forward-Looking Statements

Neuphoria cautions that statements included in this press release that are not a description of historical facts are forward-looking statements. Words such as “may,” “could,” “will,” “would,” “should,” “expect,” “plan,” “anticipate,” “believe,” “estimate,” “intend,” “predict,” “seek,” “contemplate,” “potential,” “continue” or “project” or the negative of these terms or other comparable terminology are intended to identify forward-looking statements. The forward-looking statements are based on our current beliefs, plans, burn rate and expectations. Certain forward-looking statements, including (without limitation) about (1) Neuphoria’s ability to develop and expand its business, successfully complete development of its current product candidates, the timing of commencement and/or completion, as well as any successful or other outcome of various clinical trials, and receipt of data and current and future collaborations for the development and commercialization of its product candidates, (2) the market for drugs to treat CNS diseases and pain conditions, and the Company’s ability to realize the commercial potential of its products, as well as its regulatory strategy related to its clinical trials and, if successful, the regulatory pathway to any next stage in development or commercialization, (3) Neuphoria’s financial resources, and capital allocation and corporate development strategy, and (4) assumptions underlying any such statements. The inclusion of forward-looking statements should not be regarded as a representation by Neuphoria that any of its plans will be achieved. Future events and actual results could differ materially from those set out in, contemplated by or underlying the forward-looking statements due to a number of important factors. Certain forward-looking statements involve contracts, licenses and arrangements involving third parties and their respective clinical trial and research and development projects that are out of our control, including our agreements with Merck and Carina. They may terminate or delay any or all such projects in their discretion pursuant to the terms of our agreements with them, which could result in the Company not realizing any further milestone payments or further progress on the respective product pathways. Actual results may differ materially from those set forth in this release due to the risks and uncertainties inherent in the Company’s business and other risks described in the Company’s filings with the SEC, including the Company’s Annual Report on Form 10-K, Quarterly Report on Form 10-Q, Current Reports on Form 8-K, each filed with the SEC, and its other reports. Investors are cautioned not to place undue reliance on these forward-looking statements, which speak only as of the date hereof, and Neuphoria undertakes no obligation to revise or update this news release to reflect events or circumstances after the date hereof. Further information regarding these and other risks, uncertainties and other factors is included in Neuphoria’s filings with the SEC, copies of which are available from the SEC’s website (www.sec.gov) and on Neuphoria’s website (www.neuphoriatx.com) under the heading “Investor Center.” All forward-looking statements are qualified in their entirety by this cautionary statement. This caution is made under the safe harbor provisions of Section 21E of the Private Securities Litigation Reform Act of 1995. Neuphoria expressly disclaims all liability in respect to actions taken or not taken based on any or all the contents of this press release.

FOR FURTHER INFORMATION PLEASE CONTACT:

Neuphoria Provides Fiscal Year-End 2025 Financial Results and Business Updates




Neuphoria Provides Fiscal Year-End 2025 Financial Results and Business Updates

Last patient last visit (LPLV) milestone in AFFIRM-1 Phase 3 trial of BNC-210 in social anxiety disorder (SAD) achieved; topline readout anticipated in early Q4 2025

Cash runway extended through fiscal Q2 2027

BURLINGTON, Mass., Sept. 29, 2025 (GLOBE NEWSWIRE) — Neuphoria Therapeutics Inc. (Nasdaq: NEUP) (“Neuphoria” or the “Company”), a clinical-stage biotechnology company developing impactful treatments for neuropsychiatric disorders, today reported its financial results for its fiscal year ended June 30, 2025, and provided recent business updates.

“It is an exciting time for Neuphoria as we rapidly approach topline data from our AFFIRM-1 Phase 3 study of BNC-210 in social anxiety disorder, which is anticipated early in the fourth quarter of this year,” said Spyros Papapetropoulos, M.D., Ph.D., President and CEO of Neuphoria. “BNC-210 is supported by a robust body of clinical data, demonstrating clinically meaningful effects across multiple stress and anxiety indications. These data, along with its differentiated safety profile, give us confidence in BNC-210 as a potentially transformative treatment for patients struggling with SAD.”

Clinical Program Highlights

• The LPLV milestone has been achieved in the AFFIRM-1 Phase 3 trial evaluating BNC-210 as a first-in-class, acute, “as needed” treatment for SAD. Topline data are anticipated in early fourth quarter 2025.
• Start-up activities continue for the SYMPHONY Phase 2b/3 trial in PTSD. Neuphoria plans to initiate the clinical study in the first half of 2026.
• MK-1167, one of two positive allosteric modulator (PAM) candidates being advanced in a strategic partnership with Merck & Co, Inc., is currently being evaluated in a Merck-led Phase 2 trial in Alzheimer’s disease.

June 30^th Fiscal Year-End 2025 Financial Results and Key Highlights

Cash Position: Cash and cash equivalents were $14.2 million as of June 30, 2025. The Company expects its current cash position to be sufficient to fund operations through the second fiscal quarter of 2027.

R&D Expenses: Research and development expenses were $9.0 million for the year ended June 30, 2025, compared to $9.4 million for the year ended June 30, 2024. The decrease of $0.4 million was primarily due to the timing of clinical and consulting related spend.

G&A Expenses: General and administrative expenses were $7.8 million for the year ended June 30, 2025, compared to $8.5 million for the year ended June 30, 2024. The decrease of $0.7 million was primarily due to decreases in headcount and insurance costs.

Net Loss: Net loss was $0.4 million, or $0.23 per basic and diluted share, for the year ended June 30, 2025, compared to a net loss of $15.5 million, or $18.62 per basic and diluted share, for the year ended June 30, 2024.

About BNC-210

BNC-210 is an oral, proprietary, selective negative allosteric modulator of the α7 nicotinic acetylcholine receptor under development for the treatment of SAD and post-traumatic stress disorder (PTSD). BNC-210 has been given FDA Fast Track designation for acute treatment of SAD and other anxiety related disorders, and for treatment of PTSD and other trauma and stressor related disorders. BNC-210 has demonstrated rapid-onset, broad and meaningful anti-anxiety effects in completed clinical trials in SAD, generalized anxiety disorder (GAD) and panic attacks without evidence of sedation, impairments in cognition or addiction potential.

About Neuphoria Therapeutics Inc.

Neuphoria (Nasdaq: NEUP) is a clinical-stage biotechnology company dedicated to developing therapies that address the complex needs of individuals affected by neuropsychiatric disorders. Neuphoria is advancing its lead drug candidate, BNC-210, an oral, proprietary, selective negative allosteric modulator of the α7 nicotinic acetylcholine receptor, for the acute, “as needed” treatment of social anxiety disorder (SAD) and for chronic treatment of post-traumatic stress disorder (PTSD). BNC-210 is a first-of-its-kind, well-tolerated, broad spectrum anti-anxiety experimental therapeutic, designed to restore neurotransmitter balance in relevant brain areas, providing rapid relief from stress and anxiety symptoms without the common pitfalls of sedation, cognitive impairment, or addiction. In addition, Neuphoria has a strategic partnership with Merck & Co., Inc. (known as MSD outside the United States and Canada) with two drugs in early-stage clinical trials for the treatment of cognitive deficits in Alzheimer’s disease and other central nervous system conditions. Neuphoria’s pipeline also includes the α7 nicotinic acetylcholine receptor next generation and the Kv3.1/3.2 preclinical programs, both in the lead optimization development stage.

Forward-Looking Statements

Neuphoria cautions that statements included in this press release that are not a description of historical facts are forward-looking statements. Words such as “may,” “could,” “will,” “would,” “should,” “expect,” “plan,” “anticipate,” “believe,” “estimate,” “intend,” “predict,” “seek,” “contemplate,” “potential,” “continue” or “project” or the negative of these terms or other comparable terminology are intended to identify forward-looking statements. The forward-looking statements are based on our current beliefs, plans, burn rate and expectations. Certain forward-looking statements, including (without limitation) about (1) Neuphoria’s ability to develop and expand its business, successfully complete development of its current product candidates, the timing of commencement and/or completion, as well as any successful or other outcome of various clinical trials, and receipt of data and current and future collaborations for the development and commercialization of its product candidates, (2) the market for drugs to treat CNS diseases and pain conditions, and the Company’s ability to realize the commercial potential of its products, as well as its regulatory strategy related to its clinical trials and, if successful, the regulatory pathway to any next stage in development or commercialization, (3) Neuphoria’s financial resources, and capital allocation and corporate development strategy, and (4) assumptions underlying any such statements. The inclusion of forward-looking statements should not be regarded as a representation by Neuphoria that any of its plans will be achieved. Future events and actual results could differ materially from those set out in, contemplated by or underlying the forward-looking statements due to a number of important factors. Certain forward-looking statements involve contracts, licenses and arrangements involving third parties and their respective clinical trial and research and development projects that are out of our control, including our agreements with Merck and Carina. They may terminate or delay any or all such projects in their discretion pursuant to the terms of our agreements with them, which could result in the Company not realizing any further milestone payments or further progress on the respective product pathways. Actual results may differ materially from those set forth in this release due to the risks and uncertainties inherent in the Company’s business and other risks described in the Company’s filings with the SEC, including the Company’s Annual Report on Form 10-K, Quarterly Report on Form 10-Q, Current Reports on Form 8-K, each filed with the SEC, and its other reports. Investors are cautioned not to place undue reliance on these forward-looking statements, which speak only as of the date hereof, and Neuphoria undertakes no obligation to revise or update this news release to reflect events or circumstances after the date hereof. Further information regarding these and other risks, uncertainties and other factors is included in Neuphoria’s filings with the SEC, copies of which are available from the SEC’s website (www.sec.gov) and on Neuphoria’s website (www.neuphoriatx.com) under the heading “Investor Center.” All forward-looking statements are qualified in their entirety by this cautionary statement. This caution is made under the safe harbor provisions of Section 21E of the Private Securities Litigation Reform Act of 1995. Neuphoria expressly disclaims all liability in respect to actions taken or not taken based on any or all the contents of this press release.

FOR FURTHER INFORMATION PLEASE CONTACT:

Precision Optics Reports Fourth Quarter and Fiscal Year 2025 Financial Results




Precision Optics Reports Fourth Quarter and Fiscal Year 2025 Financial Results

Conference Call Scheduled for today, September 29, 2025, at 5:00pm ET

Company introduces fiscal year 2026 Revenue and Adjusted EBITDA guidance

Company appoints new Chief Operating Officer

GARDNER, Mass., Sept. 29, 2025 (GLOBE NEWSWIRE) — Precision Optics Corporation, Inc. (NASDAQ: POCI), a leading designer and manufacturer of advanced optical instruments for the medical and defense/aerospace industries, announced operating results on an unaudited basis for its fourth quarter and fiscal year 2025 for the period ended June 30, 2025.

Q4 2025 Financial Highlights (3 Months Ended June 30, 2025):

• Revenue was $6.2 million, a new quarterly record, compared to $4.7 million in the same quarter of the previous fiscal year and compared to $4.2 million in the most recent sequential quarter, representing growth of approximately 48%.
• Production revenue was $5.1 million compared to $2.8 million in the same quarter of the previous fiscal year and compared to $3.3 million in the most recent sequential quarter, representing growth of approximately 54%.
• Engineering revenue was $1.1 million compared to $1.9 million in the same quarter of the previous fiscal year and compared to $0.9 million in the most recent sequential quarter.
• Gross margins were 13.0% compared to 21.7% in the same quarter of the previous fiscal year and compared to 10.0% in the most recent sequential quarter.
• Net loss for the quarter was $(1.4) million, compared to $(1.4) million in the same quarter of the previous fiscal year, and compared to $(2.1) million in the most recent sequential quarter.
• Adjusted EBITDA was $(0.9) million for the quarter compared to $(1.1) million in the same quarter of the previous fiscal year and compared to $(1.3) million in the most recent sequential quarter.

FY 2025 Financial Highlights (Year Ended June 30, 2025):

• Revenue was $19.1 million compared to $19.1 million in the previous fiscal year.
• Production revenue was $14.2 million compared to $10.6 million in the previous fiscal year, representing growth of approximately 34%. Engineering revenue was $4.9 million compared to $8.5 million in the previous fiscal year.
• Gross margins were 17.8% compared to 30.3% in the previous fiscal year.
• Net loss was ($5.8) million compared to $(3.0) million in the previous fiscal year.
• Adjusted EBITDA was $(3.7) million compared to $(1.6) million in the previous fiscal year.

FY 2026 Financial Guidance (Year Ended June 30, 2026):

• The Company projects for the fiscal year 2026 revenue to be in excess of $25 million, which represents 31% growth over the Company’s fiscal year 2025 revenue.
• The Company expects fiscal year 2026 gross margin to be approximately 30%, an improvement compared to 18% in fiscal 2025.
• The Company projects fiscal year 2026 Adjusted EBITDA be approximately $0.5 million compared to $(3.7) million in fiscal 2025.

“During the fourth quarter, we reported quarterly revenue of $6.2 million, a new record for the Company and up 31% from the year ago quarter, as we executed against a strong order backlog driven by recent multi-year agreements with a top tier aerospace company and a surgical robotics company,” commented Dr. Joe Forkey, CEO of Precision Optics. “The challenges we faced in getting production lines ramping to greater volumes had greater financial impact than anticipated. However, the underlying growth in the business is the source. Our two largest production customers are asking us to produce greater quantities, and we are working to add to our production capacity to meet demand. It is our current expectation that fiscal 2026 revenue will be approximately $25 million, which would equate to over 30% growth from fiscal 2025.”

“Margins were impacted by production yields, staffing and efficiency challenges along with unanticipated tariff costs. During the first quarter of Fiscal 2026 we renegotiated pricing agreements with one customer to account for some of the yield shortfalls, and we expect the impact of design revisions and related manufacturing improvements to be in place later this year. These improvements are expected to result in continued gross margin gains from quarter to quarter during Fiscal 2026. Finally, we are kicking off new product development engagements resulting from our expanded outreach that will increase utilization of our engineering resources. All told, our expectation is for gross margin improvement of more than ten percentage points in fiscal 2026 with further improvements in future years.”

Appointment of New Chief Operating Officer
The Company today announced the appointment of Joseph Traut as the Company’s new Chief Operating Officer effective October 1, 2025. Mr. Traut will lead the operations team, including its production and engineering activities at its facilities in Massachusetts, Maine and Texas. Prior to joining Precision Optics, he held senior operations management roles with numerous medical device companies. In connection with Mr. Traut joining the Company, in addition to his salary and benefits, the Compensation Committee and Board of the Company approved the grant of an inducement stock option to be granted on his Start Date, to purchase 60,000 shares of the Company’s common stock. The Option was granted pursuant to the Nasdaq Rule 5635(c)(4) inducement grant exception as a component of the individual’s employment compensation and was granted as an inducement material to his acceptance of employment with the Company. Mr. Traut’s option has an exercise price equal to the closing price of the Company’s common stock as reported by the Nasdaq Capital Market on October 1, 2025. The options have a ten-year term and vest in three equal annual installments, subject to Mr. Traut’s continued service with the Company through the applicable vesting dates.

Forkey commented, “I am pleased to welcome Joe Traut as our new COO. Joe has specific expertise in building effective operations teams and transferring manufacturing operations both internationally and domestically with a history of improving business performance through operational excellence methodology and improved manufacturing efficiency. I look forward to his contributions as we continue to rapidly scale our operations.”

The following table summarizes the fourth quarter and fiscal year results for the periods ended June 30, 2025, and 2024:

Conference Call Details
Date and Time: Monday, September 29, 2025, at 5:00 p.m. ET.

Call-in Information: Interested parties can access the conference call by dialing (844) 735-3662 or
(412) 317-5705.

Live Webcast Information: Interested parties can access the conference call via a live webcast, which is available at https://app.webinar.net/09EyQ6EXoDx.

Replay: A teleconference replay of the call will be available for seven days, at (877) 344-7529 or (412) 317-0088, replay access code 3770234. A webcast replay will be available at https://app.webinar.net/09EyQ6EXoDx.

About Precision Optics Corporation
Founded in 1982, Precision Optics is a vertically integrated optics company primarily focused on leveraging its proprietary micro-optics, 3D imaging and digital imaging technologies to the healthcare and defense/aerospace industries by providing services ranging from new product concept through mass manufacture. Utilizing its leading-edge in-house design, prototype, regulatory and fabrication capabilities as well as its Ross Optical division’s high volume world-wide sourcing, inspecting and production resources, the Company is able to design and manufacture next-generation product solutions to the most challenging customer requirements. Within healthcare, Precision Optics enables next generation medical device companies around the world to meet the increasing demands of the surgical community who require more enhanced and smaller imaging systems for minimally invasive surgery as well as 3D endoscopy systems to support the rapid proliferation of surgical robotic systems. In addition to these next generation applications, Precision Optics has supplied top tier medical device companies a wide variety of optical products for decades, including complex endocouplers and specialized endoscopes. The Company is also leveraging its technical proficiency in micro-optics to enable leading edge defense/aerospace applications which require the highest quality standards and the optimization of size, weight and power. For more information, please visit www.poci.com.

Non-GAAP Financial Measures
Precision Optics has provided in this press release financial information that has not been prepared in accordance with accounting principles generally accepted in the Unites States of America (“non-GAAP”). The non-GAAP financial measure is Adjusted EBITDA (earnings before interest, taxes, depreciation and amortization). In addition to the aforementioned items, Adjusted EBITDA also excludes from Net Income (Loss) the effect of stock-based compensation.

This non-GAAP financial measure assists Precision Optics management in comparing its operating performance over time because certain items may obscure the underlying business trends and make comparisons of long-term performance difficult, as they are of a nature and/or size that occur with inconsistent frequency or relate to discrete acquisition or restructuring plans that are fundamentally different from the ongoing productivity of the Company. Precision Optics management also believes that presenting this measure allows investors to view its performance using the same measures that the Company uses in evaluating its financial and business performance and trends.

Non-GAAP financial measures should not be considered in isolation from, or as a substitute for, financial information calculated in accordance with GAAP. Investors are encouraged to review the reconciliation of non-GAAP measures to their most directly comparable GAAP financial measures. A reconciliation of the non-GAAP financial measure presented above to GAAP results has been provided in the financial tables included with this press release.

About Forward-Looking Statements
This press release contains forward-looking statements within the meaning of U.S. federal securities laws. Any statements contained herein that are not statements of historical fact may be deemed to be forward-looking statements. 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 “anticipate,” “believe,” “continue,” “could,” “estimate,” “expect,” “intends,” “may,” “might,” “plan,” “possible,” “potential,” “predict,” “project,” “should,” “would” and similar expressions may identify forward-looking statements, but the absence of these words does not mean that a statement is not forward-looking. Forward-looking statements in this press release include, without limitation, the Company’s projections for future revenue, gross margins and Adjusted EBITDA. The forward-looking statements contained in this press release are based on certain assumptions and analyses made by the management of the Company in light of their respective experience and perception of historical trends, current conditions, and expected future developments and their potential effects on the Company as well as other factors they believe are appropriate in the circumstances. There can be no assurance that future developments affecting the Company will be those anticipated. These forward-looking statements involve a number of risks, uncertainties (some of which are beyond the control of the parties), or other assumptions that may cause actual results or performance to be materially different from those expressed or implied by these forward-looking statements, including the demand for the Company’s products, global supply chains and economic activity in general and other risks and uncertainties identified in the Company’s filings with the SEC. Should one or more of these risks or uncertainties materialize or should any of the assumptions being made prove incorrect, actual results may vary in material respects from those projected in these forward-looking statements. We undertake no obligation to update or revise any forward-looking statements, whether as a result of new information, future events, or otherwise, except as may be required under applicable securities laws.

Company Contact:
PRECISION OPTICS CORPORATION
22 East Broadway
Gardner, Massachusetts 01440-3338
Telephone: 978-630-1800

Investor Contact:
LYTHAM PARTNERS, LLC
Robert Blum
Telephone: 602-889-9700
poci@lythampartners.com

Precision Optics Reports Fourth Quarter and Fiscal Year 2025 Financial Results




Precision Optics Reports Fourth Quarter and Fiscal Year 2025 Financial Results

Conference Call Scheduled for today, September 29, 2025, at 5:00pm ET

Company introduces fiscal year 2026 Revenue and Adjusted EBITDA guidance

Company appoints new Chief Operating Officer

GARDNER, Mass., Sept. 29, 2025 (GLOBE NEWSWIRE) — Precision Optics Corporation, Inc. (NASDAQ: POCI), a leading designer and manufacturer of advanced optical instruments for the medical and defense/aerospace industries, announced operating results on an unaudited basis for its fourth quarter and fiscal year 2025 for the period ended June 30, 2025.

Q4 2025 Financial Highlights (3 Months Ended June 30, 2025):

• Revenue was $6.2 million, a new quarterly record, compared to $4.7 million in the same quarter of the previous fiscal year and compared to $4.2 million in the most recent sequential quarter, representing growth of approximately 48%.
• Production revenue was $5.1 million compared to $2.8 million in the same quarter of the previous fiscal year and compared to $3.3 million in the most recent sequential quarter, representing growth of approximately 54%.
• Engineering revenue was $1.1 million compared to $1.9 million in the same quarter of the previous fiscal year and compared to $0.9 million in the most recent sequential quarter.
• Gross margins were 13.0% compared to 21.7% in the same quarter of the previous fiscal year and compared to 10.0% in the most recent sequential quarter.
• Net loss for the quarter was $(1.4) million, compared to $(1.4) million in the same quarter of the previous fiscal year, and compared to $(2.1) million in the most recent sequential quarter.
• Adjusted EBITDA was $(0.9) million for the quarter compared to $(1.1) million in the same quarter of the previous fiscal year and compared to $(1.3) million in the most recent sequential quarter.

FY 2025 Financial Highlights (Year Ended June 30, 2025):

• Revenue was $19.1 million compared to $19.1 million in the previous fiscal year.
• Production revenue was $14.2 million compared to $10.6 million in the previous fiscal year, representing growth of approximately 34%. Engineering revenue was $4.9 million compared to $8.5 million in the previous fiscal year.
• Gross margins were 17.8% compared to 30.3% in the previous fiscal year.
• Net loss was ($5.8) million compared to $(3.0) million in the previous fiscal year.
• Adjusted EBITDA was $(3.7) million compared to $(1.6) million in the previous fiscal year.

FY 2026 Financial Guidance (Year Ended June 30, 2026):

• The Company projects for the fiscal year 2026 revenue to be in excess of $25 million, which represents 31% growth over the Company’s fiscal year 2025 revenue.
• The Company expects fiscal year 2026 gross margin to be approximately 30%, an improvement compared to 18% in fiscal 2025.
• The Company projects fiscal year 2026 Adjusted EBITDA be approximately $0.5 million compared to $(3.7) million in fiscal 2025.

“During the fourth quarter, we reported quarterly revenue of $6.2 million, a new record for the Company and up 31% from the year ago quarter, as we executed against a strong order backlog driven by recent multi-year agreements with a top tier aerospace company and a surgical robotics company,” commented Dr. Joe Forkey, CEO of Precision Optics. “The challenges we faced in getting production lines ramping to greater volumes had greater financial impact than anticipated. However, the underlying growth in the business is the source. Our two largest production customers are asking us to produce greater quantities, and we are working to add to our production capacity to meet demand. It is our current expectation that fiscal 2026 revenue will be approximately $25 million, which would equate to over 30% growth from fiscal 2025.”

“Margins were impacted by production yields, staffing and efficiency challenges along with unanticipated tariff costs. During the first quarter of Fiscal 2026 we renegotiated pricing agreements with one customer to account for some of the yield shortfalls, and we expect the impact of design revisions and related manufacturing improvements to be in place later this year. These improvements are expected to result in continued gross margin gains from quarter to quarter during Fiscal 2026. Finally, we are kicking off new product development engagements resulting from our expanded outreach that will increase utilization of our engineering resources. All told, our expectation is for gross margin improvement of more than ten percentage points in fiscal 2026 with further improvements in future years.”

Appointment of New Chief Operating Officer
The Company today announced the appointment of Joseph Traut as the Company’s new Chief Operating Officer effective October 1, 2025. Mr. Traut will lead the operations team, including its production and engineering activities at its facilities in Massachusetts, Maine and Texas. Prior to joining Precision Optics, he held senior operations management roles with numerous medical device companies. In connection with Mr. Traut joining the Company, in addition to his salary and benefits, the Compensation Committee and Board of the Company approved the grant of an inducement stock option to be granted on his Start Date, to purchase 60,000 shares of the Company’s common stock. The Option was granted pursuant to the Nasdaq Rule 5635(c)(4) inducement grant exception as a component of the individual’s employment compensation and was granted as an inducement material to his acceptance of employment with the Company. Mr. Traut’s option has an exercise price equal to the closing price of the Company’s common stock as reported by the Nasdaq Capital Market on October 1, 2025. The options have a ten-year term and vest in three equal annual installments, subject to Mr. Traut’s continued service with the Company through the applicable vesting dates.

Forkey commented, “I am pleased to welcome Joe Traut as our new COO. Joe has specific expertise in building effective operations teams and transferring manufacturing operations both internationally and domestically with a history of improving business performance through operational excellence methodology and improved manufacturing efficiency. I look forward to his contributions as we continue to rapidly scale our operations.”

The following table summarizes the fourth quarter and fiscal year results for the periods ended June 30, 2025, and 2024:

Conference Call Details
Date and Time: Monday, September 29, 2025, at 5:00 p.m. ET.

Call-in Information: Interested parties can access the conference call by dialing (844) 735-3662 or
(412) 317-5705.

Live Webcast Information: Interested parties can access the conference call via a live webcast, which is available at https://app.webinar.net/09EyQ6EXoDx.

Replay: A teleconference replay of the call will be available for seven days, at (877) 344-7529 or (412) 317-0088, replay access code 3770234. A webcast replay will be available at https://app.webinar.net/09EyQ6EXoDx.

About Precision Optics Corporation
Founded in 1982, Precision Optics is a vertically integrated optics company primarily focused on leveraging its proprietary micro-optics, 3D imaging and digital imaging technologies to the healthcare and defense/aerospace industries by providing services ranging from new product concept through mass manufacture. Utilizing its leading-edge in-house design, prototype, regulatory and fabrication capabilities as well as its Ross Optical division’s high volume world-wide sourcing, inspecting and production resources, the Company is able to design and manufacture next-generation product solutions to the most challenging customer requirements. Within healthcare, Precision Optics enables next generation medical device companies around the world to meet the increasing demands of the surgical community who require more enhanced and smaller imaging systems for minimally invasive surgery as well as 3D endoscopy systems to support the rapid proliferation of surgical robotic systems. In addition to these next generation applications, Precision Optics has supplied top tier medical device companies a wide variety of optical products for decades, including complex endocouplers and specialized endoscopes. The Company is also leveraging its technical proficiency in micro-optics to enable leading edge defense/aerospace applications which require the highest quality standards and the optimization of size, weight and power. For more information, please visit www.poci.com.

Non-GAAP Financial Measures
Precision Optics has provided in this press release financial information that has not been prepared in accordance with accounting principles generally accepted in the Unites States of America (“non-GAAP”). The non-GAAP financial measure is Adjusted EBITDA (earnings before interest, taxes, depreciation and amortization). In addition to the aforementioned items, Adjusted EBITDA also excludes from Net Income (Loss) the effect of stock-based compensation.

This non-GAAP financial measure assists Precision Optics management in comparing its operating performance over time because certain items may obscure the underlying business trends and make comparisons of long-term performance difficult, as they are of a nature and/or size that occur with inconsistent frequency or relate to discrete acquisition or restructuring plans that are fundamentally different from the ongoing productivity of the Company. Precision Optics management also believes that presenting this measure allows investors to view its performance using the same measures that the Company uses in evaluating its financial and business performance and trends.

Non-GAAP financial measures should not be considered in isolation from, or as a substitute for, financial information calculated in accordance with GAAP. Investors are encouraged to review the reconciliation of non-GAAP measures to their most directly comparable GAAP financial measures. A reconciliation of the non-GAAP financial measure presented above to GAAP results has been provided in the financial tables included with this press release.

About Forward-Looking Statements
This press release contains forward-looking statements within the meaning of U.S. federal securities laws. Any statements contained herein that are not statements of historical fact may be deemed to be forward-looking statements. 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 “anticipate,” “believe,” “continue,” “could,” “estimate,” “expect,” “intends,” “may,” “might,” “plan,” “possible,” “potential,” “predict,” “project,” “should,” “would” and similar expressions may identify forward-looking statements, but the absence of these words does not mean that a statement is not forward-looking. Forward-looking statements in this press release include, without limitation, the Company’s projections for future revenue, gross margins and Adjusted EBITDA. The forward-looking statements contained in this press release are based on certain assumptions and analyses made by the management of the Company in light of their respective experience and perception of historical trends, current conditions, and expected future developments and their potential effects on the Company as well as other factors they believe are appropriate in the circumstances. There can be no assurance that future developments affecting the Company will be those anticipated. These forward-looking statements involve a number of risks, uncertainties (some of which are beyond the control of the parties), or other assumptions that may cause actual results or performance to be materially different from those expressed or implied by these forward-looking statements, including the demand for the Company’s products, global supply chains and economic activity in general and other risks and uncertainties identified in the Company’s filings with the SEC. Should one or more of these risks or uncertainties materialize or should any of the assumptions being made prove incorrect, actual results may vary in material respects from those projected in these forward-looking statements. We undertake no obligation to update or revise any forward-looking statements, whether as a result of new information, future events, or otherwise, except as may be required under applicable securities laws.

Company Contact:
PRECISION OPTICS CORPORATION
22 East Broadway
Gardner, Massachusetts 01440-3338
Telephone: 978-630-1800

Investor Contact:
LYTHAM PARTNERS, LLC
Robert Blum
Telephone: 602-889-9700
poci@lythampartners.com

Cadrenal Therapeutics to Participate in the Lytham Partners Fall 2025 Investor Conference on September 30, 2025




Cadrenal Therapeutics to Participate in the Lytham Partners Fall 2025 Investor Conference on September 30, 2025

PONTE VEDRA, Fla., Sept. 29, 2025 (GLOBE NEWSWIRE) — Cadrenal Therapeutics, Inc. (Nasdaq: CVKD), a biopharmaceutical company developing transformative therapeutics to overcome the gaps in anticoagulation therapy, today announced that it will participate in a webcast presentation and host one-on-one meetings with investors at the Lytham Partners Fall 2025 Investor Conference, taking place virtually on Tuesday, September 30, 2025.

Company Webcast

The webcast presentation will take place at 3:30 p.m. ET on Tuesday, September 30, 2025. The webcast can be accessed by visiting the conference home page at https://lythampartners.com/fall2025/ or directly at https://app.webinar.net/QG1g6kJWEM0. The webcast will also be available for replay following the event.

1×1 Meetings

Management will be participating in virtual one-on-one meetings throughout the event. To arrange a meeting with management, please contact Lytham Partners at 1×1@lythampartners.com or register for the event at https://lythampartners.com/fall2025invreg/.

About Cadrenal Therapeutics, Inc.
Cadrenal Therapeutics, Inc. is a biopharmaceutical company developing transformative therapeutics to overcome the gaps in anticoagulation therapy. Cadrenal’s lead investigational product is tecarfarin, a novel oral Vitamin K antagonist anticoagulant that is designed to address unmet needs in anticoagulation therapy. Tecarfarin is a reversible anticoagulant (blood thinner) designed to prevent heart attacks, strokes, and deaths due to blood clots in patients requiring chronic anticoagulation. Although warfarin is widely used, extensive clinical and real-world data have shown it can have significant, serious side effects. With tecarfarin, Cadrenal aims to reduce the clinical complexities of managing Vitamin K antagonists, particularly where direct-acting oral anticoagulants (DOACs) remain inadequate or unproven.

Tecarfarin received Orphan Drug Designation (ODD) and fast-track designation for the prevention of systemic thromboembolism (blood clots) of cardiac origin in patients with end-stage kidney disease and atrial fibrillation (ESKD+AFib). The Company also received ODD for the prevention of thromboembolism and thrombosis in patients with implanted mechanical circulatory support devices, including Left Ventricular Assist Devices (LVADs).

For more information, visit https://www.cadrenal.com/ and connect with the Company on LinkedIn.

For more information, please contact:

Cadrenal Therapeutics:
Matthew Szot, CFO
press@cadrenal.com

Investors:
Lytham Partners, LLC
Robert Blum, Managing Partner
602-889-9700
CVKD@lythampartners.com