Prime Mining Reports Q1 2025 Financial and Operating Results
Prime Chief Executive Officer Scott Hicks commented, 'The Prime team continued to progress our technical understanding of the Los Reyes Project through the first quarter of 2025, in preparation for a high quality, high value Preliminary Economic Assessment. Our geologists have been re-analysing lithological data, enhancing geostatistical data from early drilling and evaluating new potential discovery areas ahead of an eventual return to the field. In reflection of the quality of the Los Reyes Project, we were very well received at the prestigious Core Shack at PDAC in March. And, in April, our local team had an equally strong reception at the leading technical mining event in Latin America: the Discoveries 2025 Mining Conference in Mazatlán. We continue with our program of fiscal prudence and closed the quarter with $18 million in cash, providing a well-funded 2025 drilling campaign, which we anticipate would be further supported by the $1.10 warrants that are coming due on June 12, 2025.'
Corporate Highlights During the Quarter (Unless otherwise stated, all amounts are presented in Canadian dollars.)
On February 19th, the Company announced its 2025 Outlook for the Los Reyes Project including a planned 40,000m drill program and drilling status update.
Exploration Highlights During the QuarterExpansion Drilling Highlights at Z-TThe Company is reporting 25 core holes at the Z-T Trend, 14 of which are from Tahonitas, located in the south-east end of the Z-T Trend, with the following highlights:
5.67 gpt AuEq (2.23 gpt Au and 266.1 gpt Ag) over 4.2 m ETW in hole 24TA-149, including:
9.49 gpt AuEq (3.94 gpt Au and 428.7 gpt Ag) over 2.1 m ETW;
1.62 gpt AuEq (1.36 gpt Au and 19.9 gpt Ag) over 15.2 m ETW in hole 24TA-144, including:
4.94 gpt AuEq (4.22 gpt Au and 55.3 gpt Ag) over 3.7 m ETW;
4.93 gpt AuEq (2.55 gpt Au and 184.0 gpt Ag) over 3.3 m ETW in hole 24TA-153, including:
14.09 gpt AuEq (7.09 gpt Au and 541.0 gpt Ag) over 1.1 m ETW;
And also, 0.92 gpt AuEq (0.72 gpt Au and 15.2 gpt Ag) over 19.2 m ETW in hole 24TA-153.Expansion Drilling Highlights in the Central Trend The Company is reporting 14 core holes at the Central Trend, 9 of which are from Noche Buena, at the southernmost part of the trend, with the following highlights:
3.48 gpt AuEq (3.12 gpt Au and 27.7 gpt Ag) over 7.6 m ETW in hole 24NB-78, including:
8.64 gpt AuEq (7.8 gpt Au and 64.8 gpt Ag) over 2.8 m ETW, including:
16.22 gpt AuEq (15.00 gpt Au and 94.0 gpt Ag) over 1.4 m ETW;
2.16 gpt AuEq (1.75 gpt Au and 31.9 gpt Ag) over 11.3 m ETW in hole 24NB-67, including:
8.65 gpt AuEq (7.42 gpt Au and 95.3 gpt Ag) over 2.3 m ETW;
1.65 gpt AuEq (1.03 gpt Au and 47.6 gpt Ag) over 11.2 m ETW in hole 24NB-77, including:
4.24 gpt AuEq (2.40 gpt Au and 142.0 gpt Ag) over 1.8 m ETW.Generative Drilling Highlights: Fresnillo – A Prime Original DiscoveryThe Company is reporting 14 core holes, two that intersected only Fresnillo structures, four that intersected both Noche Buena and Fresnillo structures, and eight that intersected Mariposa structures. Fresnillo is located between the Z-T and Central Trends with the following highlights in today's results:
1.99 g/t gold-equivalent ('AuEq') (1.82 g/t Au and 13.1 g/t Ag) over 9.6 m estimated true width ('ETW') in hole 24NB-75, including:
20.02 g/t AuEq (18.4 g/t Au and 125.0 g/t Ag) over 0.8 m ETW;
2.83 g/t AuEq (2.52 g/t Au and 23.6 g/t Ag) over 6.2 m ETW in hole 24NB-71, including:
5.99 g/t AuEq (5.38 g/t Au and 47.0 g/t Ag) over 2.8 m ETW;
1.46 g/t AuEq (1.08 g/t Au and 29.7 g/t Ag) over 9.8 m ETW in hole 24NB-69, including:
6.76 g/t AuEq (5.35 g/t Au and 109.0 g/t Ag) over 1.4 m ETW;
1.45 g/t AuEq (1.17 g/t Au and 21.6 g/t Ag) over 6.8 m ETW in hole 24FRE-29.
Maintaining Health and Safety Protocols
Prime remains engaged with local stakeholders and is proactive in monitoring employees and contractors concerning general health conditions. The Company continues to closely adhere to the directives of all levels of government and relevant health authorities in Mexico and Canada.
Community Engagement and Environmental Stewardship Strategy
We continued to gather environmental and community data in the quarter in support of our ESG programs, including completion of a materiality assessment, strategic plan, and disclosure matrix. We strive to minimize the environmental footprint of our activities and ensure that Los Reyes has a positive impact on our host communities.
The Company released its initial sustainability report during April 2023 which establishes a baseline and a new yardstick to measure our progress in meeting our commitments regarding sustainability and stewardship of the environment, relevant social issues, and corporate governance. The Company expects to release its 2025 Sustainability Report in the coming weeks.
Selected Financial Data
The following selected financial data is summarized from the Company's consolidated financial statements and related notes thereto (the 'Financial Statements') for the three months ended March 31, 2025 and 2024. A copy of the Financial Statements and MD&A is available at www.primeminingcorp.ca or on SEDAR at www.sedar.com.
Three Months ended March 31, 2025
Three Months ended March 31, 2024
Loss and comprehensive loss
$(3,615,113)
$(6,450,142)
Loss per share – basic and diluted
$(0.02)
$(0.04)
March 31, 2025
December 31, 2024
Cash
$18,199,852
$19,056,585
Total assets
$33,054,051
$33,177,148
Total current liabilities
$561,298
$2,203,583
Total liabilities
$1,393,967
$3,049,145
Total shareholders' equity
$31,660,084
$30,128,003
2025 Outlook
The Company plans to continue its success-based approach to drilling to further identify new prospective targets, expand the existing resource, and infill drilling. Additional work will include geological mapping and geochemical sampling to identify further discovery areas.
Six drill rigs remain on site at Los Reyes, with planned fiscal 2025 exploration focused on:
Extending the high-grade Z-T Area shoots that remain open at depth, as well as along strike, both north and south.
Expanding the known high-grade mineralization at Guadalupe East.
Increasing the Central Area resource through additions southeast at Noche Buena and its connection to San Miguel East.
Generative target drilling of high-grade intercepts at Las Primas, Fresnillo and Mariposa to further grow these emerging resources, as well as other target discovery areas to demonstrate the significant resource expansion potential at Los Reyes.
Project activities are also planned to include:
Technical: Further refine metallurgical, geotechnical, mine planning and development parameters for project development, including process and underground mining optimization, infrastructure assessment and permitting requirements. We continue to sponsor and benefit from a strong geologist intern program, supporting geology students from local colleges and universities.
Community Engagement: Continue to engage with and support local ejidos (communities) through educational, community and environmental programming, access (road) improvements and infrastructure development.
On January 28, 2025, drilling was paused in response to a deterioration in the security situation in parts of Sinaloa, including the Los Reyes area. This pause is not currently expected to impact the Company's ability to drill a minimum 40,000m program over 12-months from the recommencement of drilling. Drill rigs remain on site and drill contractors are on standby to resume drilling as soon as security improves. The Company will continue to work with local authorities to monitor the current situation.
The Company continues to engage with several engineering firms to advance its understanding of the Los Reyes Project. Activities will continue to include review of metallurgical and geotechnical information, and engineering work contributing towards a Preliminary Economic Assessment as announced on February 19, 2025.
About the Los Reyes Gold and Silver Project
Los Reyes is a high-grade, low-sulphidation epithermal gold-silver project located in Sinaloa State, Mexico. On October 15, 2024, Prime announced an updated multi-million-ounce high-grade open pit and underground resource based on exploration drilling up to July 17, 2024. Since acquiring Los Reyes in 2019, Prime has spent more than $64 million on direct exploration activities and has completed over 221,000 metres of drilling.
October 15, 2024 Resource Statement1(based on a $1950/oz gold price, $25.24/oz silver price, economic-constrained estimate)
Mining Methodand Process
Class
Tonnage(kt)
Gold Grade (g/t)
Gold Contained(koz)
Silver Grade(g/t)
Silver Contained(koz)
Gold Equiv.(g/t)
Gold Equiv.(koz)
Silver Equiv.(g/t)
Silver Equiv.(koz)
Open Pit - Mill
Indicated
24,657
1.13
899
35.7
28,261
1.60
1,265
123.3
97,723
Inferred
7,211
0.89
207
42.8
9,916
1.45
335
111.8
25,911
Underground
Indicated
4,132
3.02
402
152.4
20,243
5.00
664
386.1
51,290
Inferred
4,055
2.10
273
78.6
10,247
3.12
406
240.7
31,380
Total Mill
Indicated
28,789
1.41
1,301
52.4
48,504
2.08
1,928
161.0
149,012
Inferred
11,266
1.33
480
55.7
20,163
2.05
741
158.2
57,291
Open Pit - Heap Leach
Indicated
20,254
0.29
190
8.4
5,492
0.40
261
31.0
20,201
Inferred
5,944
0.30
58
7.3
1,398
0.40
76
30.6
5,856
Total
Indicated
49,042
0.95
1,491
34.2
53,995
1.39
2,190
107.3
169,213
Inferred
17,210
0.97
538
39.0
21,561
1.48
817
114.1
63,147
1. Refer to the Additional Notes section for the gold equivalent grade ('AuEq') calculation method and further information.
Drilling is ongoing and suggests that the three known main deposit areas (Guadalupe, Central and Z-T) are larger than previously reported. Potential also exists for new discoveries where mineralized trends have been identified outside of the currently defined resource areas. Historic operating results indicate that an estimated 1 million ounces of gold and 60 million ounces of silver were recovered from five separate operations at Los Reyes between 1770 and 1990. Prior to Prime's acquisition, recent operators of Los Reyes had spent approximately US$20 million on exploration, engineering, and prefeasibility studies.
QA/QC Protocols and Sampling Procedures
Drill core at the Los Reyes project is drilled in predominately HQ size (63.5 millimetres 'mm'), reducing to NQ (47.6 mm) when required. Drill core samples are generally 1.50 m long along the core axis with allowance for shorter or longer intervals if required to suit geological constraints. After logging intervals are identified to be sampled, the core is cut and one half is submitted for assay. RC drilling returns rock chips and fines from a 133.35 mm diameter tricone bit. The returns are homogenized and split into 2 halves, with one half submitted for analysis and the other half stored.
Sample QA/QC measures include unmarked certified reference materials, blanks, and field duplicates as well as preparation duplicates are inserted into the sample sequence and make up approximately 8% of the samples submitted to the laboratory for each drill hole.
Samples are picked up from the Project by the laboratory personnel and transported to their facilities in Durango or Hermosillo Mexico, for sample preparation. Sample analysis is carried out by Bureau Veritas and ALS Labs, with fire assay, including over limits fire assay re-analysis, completed at their respective Hermosillo, Mexico laboratories and multi-element analysis completed in North Vancouver, Canada. Drill core sample preparation includes fine crushing of the sample to at least 70% passing less than 2 mm, sample splitting using a riffle splitter, and pulverizing a 250-gram split to at least 85% passing 75 microns.
Gold in diamond drill core is analyzed by fire assay and atomic absorption spectroscopy of a 30 g sample (code FA430 or Au-AA23). Multi-element chemistry is analyzed by 4-Acid digestion of a 0.25-gram sample split (code MA300 or ME-ICP61) with detection by inductively coupled plasma emission spectrometer for a full suite of elements.
Gold assay techniques FA430 and Au-AA23 have an upper detection limit of 10 ppm. Any sample that produces an over-limit gold value via the initial assay technique is sent for gravimetric finish via method FA-530 or Au-GRA21. Silver analyses by MA300 and ME-ICP61 have an upper limit of 200 ppm and 100 ppm, respectively. Samples with over-limit silver values are re-analyzed by fire assay with gravimetric finish FA530 or Au-GRA21.
Both Bureau Veritas and ALS Labs are ISO/IEC accredited assay laboratories.
Additional Notes
Prime's MRE as of October 15, 2024 is classified in accordance with the Canadian Institute of Mining, Metallurgy and Petroleum ('CIM') 'CIM Definition Standards - For Mineral Resources and Mineral Reserves' adopted by the CIM Council (as amended, the 'CIM Definition Standards') and in accordance with the requirements of NI 43-101. Mineral resources are not mineral reserves and do not have demonstrated economic viability.
Metres is represented by 'm'; 'etw' is Estimated True Width and is based on drill hole geometry or comparisons with other on-section drill holes; 'Au' refers to gold, and 'Ag' refers to silver; 'g/t' is grams per metric tonne; some figures may not sum due to rounding; Composite assay grades presented in summary tables are calculated using a Au grade minimum average of 0.20 g/t or 1.0 g/t as indicated in 'Au Cut-off' column of Summary Tables. Maximum internal waste included in any reported composite interval is 3.00 m. The 1.00 g/t Au cut-off is used to define higher-grade 'cores' within the lower-grade halo.
Gold equivalent grades are calculated based on an assumed gold price of US$1,950 per ounce and silver price of $25.24 per ounce, based on the formula AuEq grade (g/t) = Au grade + (Ag grade x $25.24 / $1,950). Metallurgical recoveries are not considered in the in-situ grade estimate but are estimated to be 95.6% and 81% for gold and silver, respectively, when processed in a mill, and 73% and 25% respectively when heap-leached. Additional details are available in the associated Technical Report, filed on November 27, 2024.
Qualified Person
Scott Smith, P.Geo., Executive Vice President of Exploration, is a Qualified Person for the purposes of NI 43-101 and has reviewed and approved the technical content in this news release.
About Prime Mining
Prime is managed by an ideal mix of successful mining executives, strong capital markets personnel and experienced local operators all focused on unlocking the full potential of the Project. The Company has a well-planned capital structure with a strong management team and insider ownership. Prime is targeting a material resource expansion at Los Reyes through a combination of new generative area discoveries and growth, while also building on technical de-risking activities to support eventual project development.
For further information, please visit https://www.primeminingcorp.ca/ or direct enquiries to:
Scott HicksCEO & Director
Indi GopinathanVP Capital Markets & Business Development
Prime Mining Corp.710 – 1030 West Georgia St.Vancouver, BC V6E 2Y3 Canada+1(604) 238-1659info@primeminingcorp.ca
Cautionary Notes to U.S. Investors Concerning Resource EstimatesThis news release has been prepared in accordance with the requirements of the securities laws in effect in Canada, which differ from the requirements of the U.S. securities laws. In particular, and without limiting the generality of the foregoing, the terms 'mineral reserve', 'proven mineral reserve', 'probable mineral reserve', 'inferred mineral resources,' 'indicated mineral resources,' 'measured mineral resources' and 'mineral resources' used or referenced in this presentation are Canadian mineral disclosure terms as defined in accordance with NI 43-101 under the guidelines set out in the CIM Standards. The CIM Standards differ from the mineral property disclosure requirements of the U.S. Securities and Exchange Commission (the 'SEC') in Regulation S-K Subpart 1300 (the 'SEC Modernization Rules') under the U.S. Securities Act of 1933, as amended (the 'Securities Act'). As a foreign private issuer that is eligible to file reports with the SEC pursuant to the multijurisdictional disclosure system, the Company is not required to provide disclosure on its mineral properties under the SEC Modernization Rules and will continue to provide disclosure under NI 43-101 and the CIM Standards. Accordingly, the Company's disclosure of mineralization and other technical information may differ significantly from the information that would be disclosed had the Company prepared the information under the standards adopted under the SEC Modernization Rules.
Forward Looking Information
This news release contains certain 'forward-looking information' and 'forward-looking statements' within the meaning of Canadian securities legislation as may be amended from time to time, including, without limitation, statements regarding the perceived merit of the Company's properties, including additional exploration potential of Los Reyes, potential quantity and/or grade of minerals, the potential size of the mineralized zone, metallurgical recoveries, and the Company's exploration and development plans in Mexico. Forward-looking statements are statements that are not historical facts which address events, results, outcomes, or developments that the Company expects to occur. Forward-looking statements are based on the beliefs, estimates and opinions of the Company's management on the date the statements are made, and they involve several risks and uncertainties. Certain material assumptions regarding such forward-looking statements were made, including without limitation, assumptions regarding the price of gold, silver and copper; the accuracy of mineral resource estimations; that there will be no material adverse change affecting the Company or its properties; that all required approvals will be obtained, including concession renewals and permitting; that political and legal developments will be consistent with current expectations; that currency and exchange rates will be consistent with current levels; and that there will be no significant disruptions affecting the Company or its properties. Consequently, there can be no assurances that such statements will prove to be accurate and actual results and future events could differ materially from those anticipated in such statements. Forward-looking statements involve significant known and unknown risks and uncertainties, which could cause actual results to differ materially from those anticipated. These risks include, but are not limited to: risks related to uncertainties inherent in the preparation of mineral resource estimates, including but not limited to changes to the cost assumptions, variations in quantity of mineralized material, grade or recovery rates, changes to geotechnical or hydrogeological considerations, failure of plant, equipment or processes, changes to availability of power or the power rates, ability to maintain social license, changes to interest or tax rates, changes in project parameters, delays and costs inherent to consulting and accommodating rights of local communities, environmental risks, title risks, including concession renewal, commodity price and exchange rate fluctuations, risks relating to COVID-19 and other future pandemics, delays in or failure to receive access agreements, on-going receipt of amended and/or operating permits, risks inherent in the estimation of mineral resources; and risks associated with executing the Company's objectives and strategies, including costs and expenses, physical access to the property, security risks, availability of contractors and skilled labour, as well as those risk factors discussed in the Company's most recently filed management's discussion and analysis, as well as its annual information form dated March 25, 2024, available on www.sedarplus.ca. Except as required by the securities disclosure laws and regulations applicable to the Company, the Company undertakes no obligation to update these forward-looking statements if management's beliefs, estimates or opinions, or other factors, should change.
Hashtags
Try Our AI Features
Explore what Daily8 AI can do for you:
Comments
No comments yet...
Related Articles
Yahoo
24 minutes ago
- Yahoo
The Headrest Safe Makes Television Debut on 'Surviving Mann' Reality Series
The episode will highlight the vehicle storage system's mission-ready capabilities on July 21 on the Pursuit Channel. HOMEWOOD, Ala., July 18, 2025 /PRNewswire/ -- The Headrest Safe Company — the innovator of the world's first-ever discreet vehicle safe storage system — is proud to announce its Headrest Safe will be featured in the popular Surviving Mann television series airing on Monday, July 21, 2025, on the Pursuit Channel. The product will be demonstrated by contestants during the show's fourth episode of the fourth season. During the episode, contestants will showcase the ease of using a Headrest Safe system for drivers who need to quickly and securely access their firearm. "People carry firearms, but when they get in their car, they may not want to carry it on them or they don't have a place to put it," said The Headrest Safe Company Revenue Director Todd Pearson during the episode. "We have created a safe storage place for them to put it in the car that's always locked up but also very accessible. It's right by your hands, and it's one of the few safes that you can access while you're driving." The Headrest Safe provides drivers with a discreet, secure way to store highly valuable and personal items, including firearms, cash, identification documents and more. All Headrest Safe products utilize high-quality materials to keep items safe and out of the hands of intruders, valets, children and others. Now in its fourth season, Surviving Mann follows contestants as they compete in special ops training locations for the chance to lead a tactical team assembled by SEAL Team 6 Operations veteran and show host Don Mann. Viewers can watch the show on the Pursuit Channel available on cable television, streaming services and on demand. Information on the series and how to watch can be found here. The product feature follows The Headrest Safe Company's recent announcement that its Compact Headrest Safe model is now available for sedan and luxury vehicle owners. For more information about The Headrest Safe Company and its line of in-vehicle safes, visit About The Headrest Safe Company, LLC The Headrest Safe Company's mission is to provide the most robust, discreet vehicle safe storage system on the market. The Headrest Safe provides drivers with options to secure valuables in their vehicle, including biometrics, passcodes or keys. The safe utilizes advanced materials, such as automotive grade coverings, 18-gauge steel safe, 16-gauge steel door and a steel lock. Based in Alabama, The Headrest Safe Company products are assembled in North America. Learn more at View original content to download multimedia: SOURCE The Headrest Safe Company Error in retrieving data Sign in to access your portfolio Error in retrieving data Error in retrieving data Error in retrieving data Error in retrieving data
Business Upturn
2 hours ago
- Business Upturn
NextGen Digital Platforms Inc. Announces New CEO, Matthew Priebe
By GlobeNewswire Published on July 18, 2025, 16:30 IST Vancouver, B.C., July 18, 2025 (GLOBE NEWSWIRE) — NextGen Digital Platforms Inc. (CSE:NXT) (OTCQB:NXTDF) (FSE:Z12) ('NextGen' or the 'Company') a digital asset and fintech platform bridging traditional capital markets with Web3 infrastructure, is pleased to announce the appointment of Matthew Priebe as Chief Executive Officer. Alexander Tjiang will step down as Interim Chief Executive Officer, and will stay on as Director, where he will continue to provide strategic guidance, oversight, and leadership to the Company. Mr. Priebe brings a decade of experience in alternative investments, the exempt market, and capital markets, having held both founding and leadership roles. Mr. Priebe founded a private-fund consulting firm and oversees an exempt market practice, serving family offices, high-net-worth individuals, and institutional clients. In addition, Mr. Priebe is a partner at a Toronto-based real estate development firm. His capital-raising experience spans private credit, real estate, public markets, and digital assets ventures. This experience has been supported by prior roles as a currency hedging strategist, and as a wealth director at one of Canada's leading digital asset exchanges. 'NextGen bridges the reliability of traditional finance with the limitless potential of digital assets. The team has developed an innovative solution that enables investors to earn returns on otherwise idle digital assets through its recently announced debenture program. I believe this initiative will drive shareholder value, alongside additional Web3 and cash-generative ventures that we plan to announce soon. I'm honoured to join this exceptional team, and together, we're committed to scaling NextGen, thoughtfully and relentlessly,' said Matthew Priebe, newly appointed CEO of NextGen. Outgoing Interim CEO, Alex Tjiang commented: 'It has been a pleasure to serve as interim CEO of NextGen. As we begin an exciting new chapter, I remain committed to supporting the company as a board member. Matthew brings a unique blend of expertise across capital markets, private capital raising, and digital assets—making him exceptionally well-suited for this role. I'm confident in his ability to deliver on our mission: to simplify and make Web3, innovative financial structures and digital assets exposure accessible to a broader audience.' In connection with the appointment of Matthew Priebe as CEO, the Company has granted (the 'Option Grant') him an aggregate of 300,000 stock options (each, an 'Option') to purchase 300,000 common shares. The Options are exercisable for a period of 5 years from the date of Grant at a price of $0.56 per common share. The Options will vest on a quarterly basis over a period of 36 months from the date of the Option Grant. In addition, the Company granted (the 'RSU Grant') 350,000 restricted share units of the Company (each, an 'RSU') to Matthew Priebe. Each RSU represents the right to receive, once vested, one common share in the capital of the Company. The RSUs will vest in six tranches, based on meeting certain milestone over 24 months following the date of grant. All 300,000 of the Options, 350,000 of the RSUs, and the common shares underlying such Options and RSUs are subject to a hold period of four months and one day from the date of issuance. About NextGen Digital Platforms Inc. NextGen Digital Platforms Inc. (CSE: NXT) (OTCQB:NXTDF) (FSE:Z12) is a publicly listed fintech and digital asset company that provides investors with exposure to a diversified portfolio of Web3 technologies, blockchain infrastructure, and digital assets, as well as yield-bearing investment opportunities through its novel, bitcoin-backed debenture program. The Company is committed to developing innovative financial structures that align with the future of decentralized finance, while prioritizing transparency, regulatory compliance, and value creation for shareholders. NextGen also operates an e-commerce platform and a hardware-as-a-service business supporting the artificial intelligence sector, called Cloud AI hosting. For More Information: Ajay Toor, Chief Financial Officer(778) 706-6104https:// [email protected] The Exchange does not accept responsibility for the adequacy or accuracy of this release. This press release includes certain 'forward-looking information' within the meaning of applicable Canadian securities legislation. All statements contained herein, other than statements of historical fact, including, without limitation, those relating to the Offering, the intended use of proceeds, the completion of the Offering on the terms described herein or at all, the anticipated filing of a Prospectus Supplement, and the receipt of necessary regulatory approvals, constitute 'forward-looking information'. Forward-looking information is frequently, but not always, identified by words such as 'expects', 'anticipates', 'believes', 'intends', 'estimates', 'potential', 'possible', and similar expressions, or statements that events, conditions, or results 'will', 'may', 'could', or 'should' occur or be achieved. There can be no assurance that such forward-looking information will prove to be accurate, as actual results and future events could differ materially from those anticipated in such information. Accordingly, readers should not place undue reliance on forward-looking information. The Company undertakes no obligation to update forward-looking statements herein except as required by applicable securities laws. Investors are cautioned against attributing undue certainty to forward-looking statements herein. Investors are encouraged to consult the Company's public filings available on SEDAR+ for a comprehensive discussion of risk factors relevant to its business and operations. Disclaimer: The above press release comes to you under an arrangement with GlobeNewswire. Business Upturn takes no editorial responsibility for the same. Ahmedabad Plane Crash GlobeNewswire provides press release distribution services globally, with substantial operations in North America and Europe.
Business Upturn
2 hours ago
- Business Upturn
Ocugen, Inc. Announces First Patient Dosed in Phase 2/3 GARDian3 Pivotal Confirmatory Trial for OCU410ST—Novel Modifier Gene Therapy Candidate for Stargardt Disease
MALVERN, Pa., July 18, 2025 (GLOBE NEWSWIRE) — Ocugen, Inc. (Ocugen or the Company) (NASDAQ: OCGN), a pioneering biotechnology leader in gene therapies for blindness diseases, today announced that the first patient has been dosed in its Phase 2/3 GARDian3 clinical trial for OCU410ST (AAV5- hRORA )—a modifier gene therapy candidate being developed for all Stargardt disease ( ABCA4- associated retinopathies). 'Dosing the first patient is an especially significant milestone and brings us closer to our goal of addressing the unmet medical need that exists for all Stargardt patients—100,000 in the U.S. and Europe and 1 million worldwide,' said Dr. Shankar Musunuri, Chairman, CEO, and Co-founder of Ocugen. 'Progressing our second modifier gene therapy candidate into a registration clinical trial is a pivotal step in potentially providing a one-time therapy for life for the millions of patients affected by inherited retinal diseases.' The Phase 2/3 clinical trial for OCU410ST builds upon encouraging results and positive data from the Phase 1 GARDian trial, which demonstrated 48% slower lesion growth at 12-month follow up in evaluable treated eyes compared to untreated eyes. Additionally, evaluable treated eyes showed a statistically significant (p=0.031) and clinically meaningful improvement of nearly 2-line gain in best corrected visual acuity (BCVA) at 12-month follow-up when compared to untreated eyes. 'Initiating dosing in this pivotal Phase 2/3 study is an important advancement for Ocugen and more importantly for the Stargardt community,' said Dr. Huma Qamar, Chief Medical Officer of Ocugen. 'The adaptive design of this trial, including a masked interim analysis at 8 months on 24 subjects, enables us to efficiently evaluate early signals of efficacy and safety while optimizing study conduct. This ensures we generate robust and meaningful data to support our regulatory submissions for approvals.' 'Treating the first patient with this novel gene therapy in the GARDian3 trial is a proud and hopeful moment for our team and for families affected by Stargardt disease,' said Victor H. Gonzalez, MD, Principal Investigator and retinal surgeon at Valley Retina Institute, McAllen, Texas. 'For decades, patients have faced the progressive loss of central vision with no approved treatment options. The encouraging Phase 1 results give us confidence that OCU410ST could meaningfully slow disease progression and help preserve vision. This trial brings us closer to the possibility of a one-time gene therapy that could transform patients' quality of life for years to come.' OCU410ST maintains a favorable safety and tolerability profile with no serious adverse events or adverse events of special interest, including ischemic optic neuropathy, vasculitis, intraocular inflammation, endophthalmitis or choroidal neovascularization. The Phase 2/3 study will enroll 51 participants diagnosed with Stargardt disease. Of these, 34 will receive a one-time subretinal injection of OCU410ST (200 μL at a concentration of 1.5 × 10¹¹ vector genomes/mL) in the eye with poorer visual acuity, while 17 will be assigned to an untreated control group. The primary objective of the trial is to evaluate the reduction in atrophic lesion size. Key secondary endpoints include improvements in BCVA and low luminance visual acuity (LLVA), compared to controls. Data from the one-year follow-up will be used to support the company's planned Biologics License Application (BLA). The OCU410ST Phase 2/3 pivotal confirmatory trial represents Ocugen's second late-stage clinical program. Ocugen plans to submit a BLA for OCU410ST in 2027 in alignment with its strategic goal of filing three BLAs over the next three years. About OCU410ST OCU410ST utilizes an AAV delivery platform for the retinal delivery of the RORA (RAR-Related Orphan Receptor A) gene. It represents Ocugen's modifier gene therapy approach, which is based on Nuclear Hormone Receptor (NHR) RORA that regulates pathophysiological pathways linked to Stargardt disease, such as lipofuscin formation, oxidative stress, complement formation, inflammation, and cell survival networks. About Stargardt Disease Stargardt disease is a genetic eye disorder that causes retinal degeneration and vision loss. Stargardt disease is the most common form of inherited macular degeneration. The progressive vision loss associated with Stargardt disease is caused by the degeneration of photoreceptor cells in the central portion of the retina called the macula. Decreased central vision due to loss of photoreceptors in the macula is the hallmark of Stargardt disease. Some peripheral vision is usually preserved. Stargardt disease typically develops during childhood or adolescence, but the age of onset and rate of progression can vary. The retinal pigment epithelium (RPE), a layer of cells supporting photoreceptors, is also affected in people with Stargardt disease. About Ocugen, Inc. Ocugen, Inc. is a biotechnology company focused on discovering, developing, and commercializing novel gene therapies to address major blindness diseases and offer hope for patients across the globe. We are making an impact on patient's lives through courageous innovation—forging new scientific paths that harness our unique intellectual and human capital. Our breakthrough modifier gene therapy platform has the potential to address significant unmet medical need for large patient populations through our gene-agnostic approach. Discover more at and follow us on X and LinkedIn. Cautionary Note on Forward-Looking Statements This press release contains forward-looking statements within the meaning of The Private Securities Litigation Reform Act of 1995, including, but not limited to, statements regarding qualitative assessments of available data, potential benefits, expectations for ongoing clinical trials, anticipated regulatory filings and anticipated development timelines, which are subject to risks and uncertainties. We may, in some cases, use terms such as 'predicts,' 'believes,' 'potential,' 'proposed,' 'continue,' 'estimates,' 'anticipates,' 'expects,' 'plans,' 'intends,' 'may,' 'could,' 'might,' 'will,' 'should,' or other words that convey uncertainty of future events or outcomes to identify these forward-looking statements. Such statements are subject to numerous important factors, risks, and uncertainties that may cause actual events or results to differ materially from our current expectations, including, but not limited to, the risks that preliminary, interim and top-line clinical trial results may not be indicative of, and may differ from, final clinical data; the ability of OCU410ST to perform in humans in a manner consistent with nonclinical, preclinical or previous clinical study data; that unfavorable new clinical trial data may emerge in ongoing clinical trials or through further analyses of existing clinical trial data; that earlier non-clinical and clinical data and testing of may not be predictive of the results or success of later clinical trials; and that that clinical trial data are subject to differing interpretations and assessments, including by regulatory authorities. These and other risks and uncertainties are more fully described in our periodic filings with the Securities and Exchange Commission (SEC), including the risk factors described in the section entitled 'Risk Factors' in the quarterly and annual reports that we file with the SEC. Any forward-looking statements that we make in this press release speak only as of the date of this press release. Except as required by law, we assume no obligation to update forward-looking statements contained in this press release whether as a result of new information, future events, or otherwise, after the date of this press release. Contact:Tiffany HamiltonAVP, Head of Communications [email protected]
