NEW YORK–(BUSINESS WIRE)– Vince Holding Corp., (Nasdaq: VNCE) (“VNCE” or the “Company”), a global retail platform, today announced that it plans to report its second quarter 2026 financial results pre-market on Thursday, September 10, 2026. The Company also plans to hold a conference call to discuss its financial results on the same day at 8:30 a.m. ET. During the conference call, the Company may answer questions concerning business and financial developments, trends and other business or financial matters. The Company’s responses to these questions, as well as other matters discussed during the conference call, may contain or constitute information that has not been previously disclosed.
Those who wish to participate in the call may do so by dialing (833) 461-5787, conference ID: 879 266 281. Any interested party will also have the opportunity to access the call via the Internet at http://investors.vince.com/. To listen to the live call, please go to the website at least 15 minutes early to register and download any necessary audio software. For those who cannot listen to the live broadcast, a recording will be available for 12 months after the date of the event. Recordings may be accessed at http://investors.vince.com/.
ABOUT VINCE HOLDING CORP. Vince Holding Corp. is a global retail platform that operates the Vince brand women’s and men’s ready to wear business and the October’s Very Own (“OVO”) brand apparel and accessories business. Vince, established in 2002, is a leading global luxury apparel and accessories brand best known for creating elevated yet understated pieces for every day effortless style. Vince operates 41 full-price retail stores, 12 outlet stores, and its e-commerce site, vince.com, as well as through premium wholesale channels globally. OVO is a Canadian lifestyle brand originally founded in 2008 by Aubrey “Drake” Graham and a Toronto collective offering premium apparel and accessories. OVO operates 12 flagship retail stores worldwide and its e-commerce site, octobersveryown.com. Please visit investors.vince.com for more information.
IND submitted to FDA for Eledon-sponsored, registrational study of tegoprubart in islet cell transplantation for patients with type 1 diabetes
First patients enrolled in new investigator-initiated study of tegoprubart in patients with renal dysfunction receiving an islet cell transplant
First patient dosed under compassionate use of tegoprubart for conversion from tacrolimus in islet cell transplant recipients with calcineurin inhibitor related kidney dysfunction
First patients dosed under compassionate use of tegoprubart in highly sensitized patients with pre-existing antibodies receiving a kidney transplant
Company on track to initiate global Phase 3 LEGACY trial of tegoprubart in kidney transplantation in Q4 2026
IRVINE, Calif., Sept. 03, 2026 (GLOBE NEWSWIRE) — Eledon Pharmaceuticals, Inc. (“Eledon”) (Nasdaq: ELDN) today announced significant progress across multiple tegoprubart development programs in kidney allotransplantation and islet cell transplantation. The Company also reaffirmed that it remains on track to initiate LEGACY, its global Phase 3 clinical trial evaluating its investigational novel immunosuppression therapy tegoprubart, an anti-CD40L antibody, in patients undergoing kidney transplantation, in the fourth quarter of 2026.
“The progress announced today reflects the growing breadth and momentum of tegoprubart’s clinical development across multiple transplant settings as we work to redefine transplant immunomodulation,” said David-Alexandre C. Gros, M.D., Chief Executive Officer of Eledon. “We remain on track to initiate our global Phase 3 LEGACY trial in kidney transplantation in the fourth quarter of 2026, while the submission of an IND for our first Company-sponsored islet cell transplantation study represents an important regulatory milestone for the tegoprubart program. In parallel, investigator-initiated studies and compassionate-use experience are expanding the clinical evaluation of tegoprubart into transplant populations with significant unmet needs, including in patients experiencing calcineurin inhibitor-related toxicities and in highly sensitized kidney transplant recipients who face elevated immunologic risk. These new programs are expected to generate important clinical insights and data updates over the next 12 months.”
Islet Cell Transplantation
IND submitted for Eledon-sponsored islet cell transplantation study in type 1 diabetes. Eledon has submitted an Investigational New Drug (IND) application to the U.S. Food and Drug Administration (FDA) for a planned Company-sponsored, registrational clinical trial evaluating tegoprubart for the prevention of allograft rejection in type 1 diabetes (T1D) patients undergoing pancreatic islet cell transplantation. The planned study would be Eledon’s first Company-sponsored clinical trial in islet cell transplantation and represents an important step in the Company’s registrational pathway for tegoprubart in this patient population.
First patients enrolled in a new investigator-initiated study involving islet cell transplant recipients with T1D and chronic kidney disease. The first patients have been enrolled in an investigator-initiated clinical trial evaluating tegoprubart for the prevention of allograft rejection in patients with T1D and renal dysfunction from chronic kidney disease receiving an islet cell transplant. The study, underway at the University of Chicago Medicine Transplant Institute, evaluates a calcineurin inhibitor–free, tegoprubart-based immunosuppression regimen in patients who are especially susceptible to tacrolimus toxicity, including kidney damage, which has long constrained the use of islet cell transplantation.
First islet cell transplant recipient dosed with tegoprubart following conversion from tacrolimus. The first islet cell transplant recipient has been dosed with tegoprubart under a compassionate-use protocol allowing them to switch from their previous tacrolimus-based immunosuppression therapy due to calcineurin inhibitor–related renal dysfunction. This compassionate use of tegoprubart may address an important unmet need among transplant recipients who require lifelong immunosuppression therapy to preserve graft function but experience renal complications often associated with calcineurin inhibitors such as tacrolimus, today’s standard of care.
Ongoing UChicago Medicine investigator-initiated study in participants with T1D undergoing islet cell transplantation expanded by three patients. UChicago Medicine is adding three additional patients in its ongoing investigator-initiated islet cell transplantation study evaluating tegoprubart as the core immunosuppressant, expanding the study beyond the 12 patients treated to date. This enrollment expansion builds on previously reported results in which all 12 patients with T1D achieved insulin independence, producing their own insulin and no longer requiring exogenous insulin therapy to manage their disease, and a hemoglobin A1c (HbA1c) level below 7.0% following islet cell transplantation and treatment with tegoprubart. Stable islet graft function was observed across all 12 study participants through a maximum reported follow-up of 22 months. Tegoprubart demonstrated a favorable tolerability profile, with no evidence of nephrotoxicity, hypertension, or neurotoxicity, which are side effects often associated with calcineurin inhibitors such as tacrolimus.
Kidney Transplantation
Phase 3 LEGACY clinical trial on track to initiate in Q4 2026. Following its successful End-of-Phase 2 meeting with the FDA, Eledon remains on track to initiate its global Phase 3 trial of tegoprubart in kidney transplantation (LEGACY) in the fourth quarter of 2026. The LEGACY trial is expected to enroll approximately 600 patients, with a primary endpoint of non-inferiority versus tacrolimus at 52 weeks based on a composite of biopsy-proven acute rejection (BPAR), graft loss, and death.
First highly sensitized kidney transplant patient dosed under compassionate use. The first highly sensitized kidney transplant patient has been dosed with tegoprubart under a compassionate-use protocol at Duke University Medical Center. Highly sensitized patients requiring a kidney transplant face a substantial unmet need because pre-existing antibodies can significantly limit access to compatible donor organs and increase the risk of antibody-mediated rejection and graft loss post-transplant. The compassionate use of tegoprubart in this setting will help expand our clinical insights and understanding of tegoprubart’s potential in a particularly challenging patient population.
Third patient treated in investigator-initiated kidney transplant tolerance study. A third patient has been treated in the investigator-initiated study evaluating tegoprubart for kidney transplant tolerance induction at Massachusetts General Hospital (MGH). Tolerance induction has the potential to eliminate the need for patients to require lifelong immunosuppression therapy.
About Eledon Pharmaceuticals and tegoprubart
Eledon Pharmaceuticals, Inc. is a clinical stage biotechnology company that is developing immune-modulating therapies for the management and treatment of life-threatening conditions. The Company’s lead investigational product is tegoprubart, an anti-CD40L antibody with high affinity for the CD40 Ligand, a well-validated biological target that has broad therapeutic potential. The central role of CD40L signaling in both adaptive and innate immune cell activation and function positions it as an attractive target for non-lymphocyte depleting, immunomodulatory therapeutic intervention. The Company is building upon a deep historical knowledge of anti-CD40L biology to conduct preclinical and clinical studies in kidney allograft transplantation, xenotransplantation, islet cell transplantation, liver transplantation and amyotrophic lateral sclerosis (ALS). Eledon is headquartered in Irvine, California. For more information, please visit the Company’s website at www.eledon.com.
Follow Eledon Pharmaceuticals on social media: LinkedIn; Twitter
Forward-Looking Statements
This press release contains forward-looking statements that involve substantial risks and uncertainties. Any statements about the company’s future expectations, plans and prospects, including statements about planned clinical trials, the development of product candidates, expected timing for initiation of future clinical trials, expected timing for receipt of data from clinical trials, the company’s capital resources and ability to finance planned clinical trials, as well as other statements containing the words “believes,” “anticipates,” “plans,” “expects,” “estimates,” “intends,” “predicts,” “projects,” “targets,” “looks forward,” “could,” “may,” and similar expressions, constitute forward-looking statements within the meaning of the Private Securities Litigation Reform Act of 1995. Specifically, our ability to achieve our anticipated future development and corporate milestones depends on our ability to obtain additional financing on acceptable terms. Forward-looking statements are inherently uncertain and are subject to numerous risks and uncertainties, including: our short operating history and shifts in our business strategy; our operating losses since inception; our need for additional funding to develop our lead drug candidate and our ability to secure additional funding on acceptable terms or at all; the impact of issuances of our common stock, including the possibility of dilution or a decline in our stock price; our ability to successfully develop our product candidates; unfavorable global economic and financial market conditions; the regulatory environment of our business and our ability to obtain required regulatory approvals; results of non-clinical studies and clinical trials, and risks that non-clinical studies or early clinical trials may not be predictive of results of later-stage clinical trials; delays or difficulties in enrollment of patients in clinical trials; our ability to attract and retain our executives and key employees; legislation of the pharmaceutical and healthcare industries; cybersecurity and data privacy risks; the ability of our products to achieve marketing approval; competition in our industry; our ability to obtain insurance coverage; our dependence on contract research organizations; our ability to protect our intellectual property; public health crises; our ability to maintain proper and effective internal control over financial reporting and other risks disclosed in our Annual Report on Form 10-K for the year ended December 31, 2025, filed with the Securities and Exchange Commission on March 19, 2026. Actual results may differ materially from those indicated by such forward-looking statements as a result of various factors. These risks and uncertainties, as well as other risks and uncertainties that could cause the company’s actual results to differ materially from the forward-looking statements contained herein, are discussed in our Annual Report on Form 10-K, and other filings with the U.S. Securities and Exchange Commission, which can be found at www.sec.gov. Any forward-looking statements contained in this press release speak only as of the date hereof and not as of any future date, and the company expressly disclaims any intent to update any forward-looking statements, whether as a result of new information, future events or otherwise.
DODGEVILLE, Wis., Sept. 03, 2026 (GLOBE NEWSWIRE) — Lands’ End, Inc. (NASDAQ: LE) today announced financial results for the second quarter ended July 31, 2026.
Charlie Cole, Chief Executive Officer, stated, “Since joining Lands’ End, I have been energized by what I see ahead for this iconic American company. What excites me most is the clear runway we have to utilize our stellar brand strength and deep customer loyalty to further strengthen our customer engagement, expand our digital capabilities, and more effectively reach and convert new customers. Our focus now is on excellence in execution to ensure we have the right infrastructure, technology, and customer acquisition capabilities in place as we head into the holiday season. I am confident we are well positioned, and I look forward to sharing more in the months ahead.”
Second Quarter Financial Highlights
Net revenue was $302.0 million for the second quarter of 2026, an increase of $7.9 million or 2.7% from $294.1 million during the second quarter of 2025.
U.S. Digital Segment Net revenue was $268.9 million for the second quarter of 2026, an increase of $13.6 million or 5.3% from $255.3 million in the second quarter of 2025.
U.S. eCommerce Net revenue was $182.4 million for the second quarter of 2026, an increase of $15.1 million or 9.0% from $167.3 million in the second quarter of 2025. The increase was primarily driven by carryover shipments from the temporary disruption associated with the rollout of the new warehouse management system in the first quarter of 2026.
Outfitters Net revenue was $69.3 million for the second quarter of 2026, an increase of $2.9 million or 4.4% from $66.4 million in the second quarter of 2025. The increase was driven by enterprise accounts which more than offset the impact of warehouse management system challenges affecting the processing of value-added service products in our school uniform business.
Third Party Net revenue was $17.2 million, for the second quarter of 2026, a decrease of $4.4 million or 20.4% from $21.6 million during the second quarter of 2025. The decrease was primarily due to prioritizing profitable high-quality sales and brand quality over lower-value promotional volume.
Europe eCommerce Net revenue was $19.7 million for the second quarter of 2026, an increase of $0.1 million or 0.5%, from $19.6 million during the second quarter of 2025. The increase was primarily due to a strategic shift to a franchise-first assortment simplifying the business and improving product margins.
Gross profit was $157.0 million for the second quarter of 2026, an increase of $13.6 million or 9.5% from $143.4 million during the second quarter of 2025. Gross margin increased approximately 320 basis points to 52.0% in the second quarter of 2026, compared with 48.8% in the second quarter of 2025. The gross margin increase was primarily driven by the IEEPA tariff refunds, partially offset by the new royalty structure associated with the JV, and temporary costs associated with our new warehouse management system.
Selling and administrative expenses increased $5.9 million to $135.3 million or 44.8% of Net revenue in the second quarter of 2026, compared with $129.4 million or 44.0% of Net revenue in the second quarter of 2025. The approximately 80 basis point increase was driven by investment in digital marketing focused on new customer acquisition and operational inefficiencies from the temporary disruption of the new warehouse management system partially offset by leverage from higher net revenue.
Net income was $3.5 million, and $0.11 earnings per diluted share in the second quarter of 2026 compared to Net loss of $3.7 million and $0.12 loss per diluted share in the second quarter of 2025.
Adjusted net income was $2.7 million and Adjusted diluted earnings per share was $0.09 in the second quarter of 2026, compared to Adjusted net loss of $1.1 million and Adjusted diluted loss per share of $0.04 in the second quarter of 2025.
Adjusted EBITDA was $11.3 million in the second quarter of 2026, a decrease of 25% compared to $15.1 million in the second quarter of 2025.
Balance Sheet and Cash Flow Highlights
Cash and cash equivalents were $16.1 million as of July 31, 2026, compared to $21.3 million as of August 1, 2025.
Inventories were $342.0 million as of July 31, 2026, and $301.8 million as of August 1, 2025, representing a 13% year over year increase. That increase primarily reflects inventory levels consistent with the Company’s normal seasonal build and support its current revenue projections compared to the intentionally lean inventory position the Company held a year ago amid tariff uncertainty.
Net cash used in operating activities was $86.5 million for the 26 weeks ended July 31, 2026, compared to net cash provided by operating activities of $0.5 million for the 26 weeks ended August 1, 2025. The increase in net cash used in operating activities was primarily due to the impact of the closing of the WHP Global transaction and the seasonal build of inventory to support the fall and holiday selling seasons.
As previously announced, the Company used the majority of the $300 million in cash proceeds from the WHP Global transaction to fully repay its term loan.
As of July 31, 2026, the Company had $60.0 million of borrowings outstanding and $89.3 million of availability under its ABL Facility, compared to $35.0 million of borrowings and $87.6 million of availability as of August 1, 2025.
During the second quarter of 2026, the Company repurchased $10.5 million of the Company’s common stock under the share repurchase program announced on April 1, 2026. As of July 31, 2026, additional purchases of up to $89.2 million could be made under the current program through March 31, 2029.
Outlook
Bernie McCracken, Chief Financial Officer, stated, “We made meaningful progress during the second quarter, moving beyond the distribution center challenges that affected our operations earlier in the year. Our core U.S. eCommerce operations normalized during the quarter and Outfitters has now returned to normal operating levels. We also repurchased approximately 3% of our outstanding shares, reflecting our disciplined approach to capital allocation and our confidence in the long-term value of Lands’ End. Combined with our significantly reduced debt and interest expense, these developments provide a stronger foundation for executing through the holiday season and creating long-term value.”
The Company’s guidance reflects current conditions, including tariffs at currently implemented rates and prevailing macroeconomic factors.
For Third Quarter fiscal 2026 the Company expects:
Net revenue to be between $300.0 million and $330.0 million.
Net loss to be between $1.0 million and net income of $3.0 million and diluted loss per share to be between $0.03 and diluted earnings per share of $0.10.
Adjusted net income to be between $2.0 million and $6.0 million and Adjusted diluted earnings per share to be between $0.07 and $0.20.
Adjusted EBITDA in the range of $14.0 million to $18.0 million.
For fiscal 2026 the Company now expects:
Net revenue to be between $1.30 billion and $1.35 billion.
Net income to be between $317.0 million and $325.0 million and diluted earnings per share to be between $10.87 and $11.14.
Adjusted net income to be between $13.0 million and $21.0 million and Adjusted diluted earnings per share to be between $0.44 and $0.72.
Adjusted EBITDA in the range of $62.0 million to $70.0 million.
For the full year, the Company’s guidance includes approximately $40.0 million of capital expenditures.
Conference Call
The Company will host a conference call on Thursday, September 3, 2026, at 8:30 a.m. ET to review its second quarter financial results. The call may be accessed through the Investor Relations section of the Company’s website at http://investors.landsend.com.
About Lands’ End, Inc.
Lands’ End, Inc. (NASDAQ:LE) is a leading digital retailer of solution-based apparel, swimwear, outerwear, accessories, footwear, home products and uniforms. Lands’ End offers products online at www.landsend.com, through third-party distribution channels and our own Company Operated stores. Lands’ End also offers products to businesses and schools, for their employees and students, through the Outfitters distribution channel. Lands’ End is a classic American lifestyle brand that creates solutions for life’s every journey.
Forward-Looking Statements
This press release contains forward-looking statements that involve risks and uncertainties, including statements regarding the future of the Company, brand strength, customer loyalty, customer engagement, digital capabilities and new customers; ensuring the right infrastructure, technology and customer acquisition capabilities, and the Company’s positioning; expectations regarding inventory, revenue and tariffs; the share repurchase program and its anticipated scale and impact; distribution center operations; confidence in the long-term value of the Company; execution through the holiday season and long-term value creation; and the Company’s Q3 and full fiscal year 2026 outlook and expectations as to Net revenue, Net income (loss), Adjusted net income, diluted earnings (loss) per share, Adjusted EBITDA and capital expenditures. The following important factors and uncertainties, among others, could cause actual results to differ materially from those described in these forward-looking statements: the stock repurchase program may not be executed to the full extent within its duration, due to business or market conditions; risks associated with the Company’s license agreement relating to the Lands’ End brand; failure to protect or preserve the image of the Company’s brands, reputation or intellectual property rights; the ability of the Company’s principal stockholders to exert substantial influence over the Company; risks associated with the implementation, stabilization and performance of the Company’s warehouse management system and distribution center operations; the Company’s results may be materially impacted if tariffs on imports to the United States increase and it is unable to offset the increased costs from current or future tariffs through pricing negotiations with its vendor base, moving production out of countries impacted by the tariffs, passing through a portion of the cost increases to the customer, or other savings opportunities; global supply chain challenges and their impact on inbound transportation costs and delays in receiving product; disruption in the Company’s supply chain, including with respect to its distribution centers, third-party manufacturing partners and logistics partners, caused by limits in freight capacity, increases in transportation costs, port congestion, other logistics constraints, and closure of certain manufacturing facilities and production lines due to public health crises and other global economic conditions; the impact of global economic conditions, including inflation, on consumer discretionary spending; the impact of public health crises on operations, customer demand and the Company’s supply chain, as well as its consolidated results of operation, financial position and cash flows; the Company’s ability to offer merchandise and services that customers want to purchase; changes in customer preference from the Company’s branded merchandise; customers’ use of the Company’s digital platform, including customer acceptance of its efforts to enhance its eCommerce websites, including the Outfitters website; customer response to the Company’s marketing efforts across all types of media; the Company’s maintenance of a robust customer list; the Company’s retail store strategy may be unsuccessful; the Company’s Third Party channel may not develop as planned or have its desired impact; the Company’s dependence on information technology; failure of information technology systems, including with respect to its eCommerce operations, or an inability to upgrade or adapt its systems; failure to adequately protect against cybersecurity threats or maintain the security and privacy of customer, employee or company information and the impact of cybersecurity events on the Company; fluctuations and increases in costs of raw materials as well as fluctuations in other production and distribution-related costs; impairment of the Company’s relationships with its vendors; the Company’s failure to compete effectively in the apparel industry; legal, regulatory, economic and political risks associated with international trade and those markets in which the Company conducts business and sources its merchandise; increases in postage, paper and printing costs; failure by third parties who provide the Company with services in connection with certain aspects of its business to perform their obligations; the Company’s failure to timely and effectively obtain shipments of products from its vendors and deliver merchandise to its customers; reliance on promotions and markdowns to encourage customer purchases; the Company’s failure to efficiently manage inventory levels; unseasonal or severe weather conditions; natural disasters, political crises or other catastrophic events; the adverse effect on the Company’s reputation if its independent vendors or licensees do not use ethical business practices or comply with contractual obligations, applicable laws and regulations; assessments for additional state taxes; incurrence of charges due to impairment of other intangible assets and long-lived assets; the impact on the Company’s business of adverse worldwide economic and market conditions, including inflation and other economic factors that negatively impact consumer spending on discretionary items; global economic, political, legislative, regulatory and market conditions (including competitive pressures), evolving legal, regulatory and tax regimes, including the effects of tariffs, inflation and foreign currency exchange rate fluctuations around the world, the challenging consumer retail market in the United States and around the world and the impact of war and other conflicts around the world; and other risks, uncertainties and factors discussed in the “Risk Factors” sections of the Company’s Annual Report on Form 10-K for the fiscal year ended January 30, 2026 as updated by the Company’s Quarterly Reports on Form 10-Q. The Company intends the forward-looking statements to speak only as of the time made and does not undertake to update or revise them as more information becomes available, except as required by law.
CONTACTS
Lands’ End, Inc. Bernard McCracken Chief Financial Officer (608) 935-4100
Investor Relations: ICR, Inc. Tom Filandro (646) 277-1235 [email protected]
New drillhole assays include 26-UH-004 reporting 3,779 g/t silver and 6.35 g/t gold over 0.30 m within a wider zone of 77.8 g/t silver and 0.14 g/t gold over 26.1 m
Hole 26-UH-006 reported 3,656 g/t silver and 1.99 g/t gold over 0.30 m within a wider zone of 137 g/t silver and 0.13 g/t gold over 9.17 m
New results and continued drill program to advance Target 01 toward a maiden NI 43-101 mineral resource estimate
Toronto, Ontario–(Newsfile Corp. – September 2, 2026) – Kuya Silver Corporation (CSE: KUYA) (OTCQB: KUYAF) (FSE: 6MR1) (the “Company” or “Kuya Silver“) is pleased to report new diamond drill assay results from Targets 01, 02 and 03 at the Umm-Hadid Project in the Kingdom of Saudi Arabia, with the principal results and ongoing resource-definition work focused on Target 01. The Umm Hadid project is owned by Silver Mining LLC, a joint venture between Sumou Holding and Kuya Silver. The results reported in this release are new and were not included in the Company’s December 22, 2025 news release, and include results from the latter part of the 2025 program which were received in 2026, as well as new drilling results completed this year.
The Target 01 new results form part of the ongoing 10,000-metre drill program. The program is designed to define the continuity, geometry and grade distribution of the silver-gold vein system and support delivery of a maiden mineral resource estimate and accompanying National Instrument 43-101 technical report. APEX Geoscience Ltd. (“APEX“) has been appointed to complete the mineral resource estimate and NI 43-101 technical report and is currently providing drilling optimization advice as results are received and interpreted.
Drill Highlights:
Hole 26-UH-004: 26.10 m grading 77.8 g/t silver and 0.14 g/t gold from 64.45 to 90.55 m, including 0.30 m grading 3,779 g/t silver and 6.35 g/t gold; and a separate 2.10 m grading 178.5 g/t silver and 0.51 g/t gold from 152.75 to 154.85 m.
Hole 26-UH-006: 9.17 m grading 137.1 g/t silver and 0.13 g/t gold from 71.00 to 80.17 m, including 1.20 m grading 959.8 g/t silver and 0.54 g/t gold, which includes 0.30 m grading 3,656 g/t silver and 1.99 g/t gold.
Hole 26-UH-002: 12.05 m grading 151.5 g/t silver and 0.26 g/t gold from 70.00 to 82.05 m, including 1.39 m grading 576.0 g/t silver and 0.31 g/t gold, and 0.31 m grading 2,960 g/t silver and 8.23 g/t gold.
Hole 26-UH-009: 2.23 m grading 421.9 g/t silver and 0.95 g/t gold from 36.94 to 39.17 m, including 1.35 m grading 695.8 g/t silver and 1.35 g/t gold, which includes 0.32 m grading 2,635 g/t silver and 4.09 g/t gold.
Hole 25-UH-037: 4.00 m grading 112.9 g/t silver and 1.44 g/t gold from 33.00 to 37.00 m, including 3.00 m grading 134.4 g/t silver and 1.92 g/t gold.
Note: Reported lengths are core lengths and do not necessarily represent true widths.
Summary of Drilling Results
A total of 59 diamond drill holes representing approximately 11,373.5 meters has been drilled up to date. This total comprises 5,135.62 meters in 29 holes previously reported in December 2025 and 6,237.88 meters in 30 additional holes from 25-UH-030 through 26-UH-016A whose new assay results are reported here. The current 10,000-metre Target 01 program remains ongoing; consequently, these results represent an interim dataset and additional drilling and assays are pending.
The current resource-definition work is focused on Target 01. Target 01 covers an approximately 4.5 km by 2.5 km area containing multiple northwest-trending veins and faults with subordinate northeast-trending splays hosted predominantly by granodiorite. Drilling is being progressively refined using geological, structural and assay information, with APEX providing independent resource-focused drilling optimization advice.
The mineralized intervals reported herein occur at depths ranging from approximately 16 to 131 meters below surface, with an average depth of approximately 58 meters.
Osbaldo Zamora, Kuya Silver’s Vice President of Exploration, commented: “These new results confirm that Target 01 hosts multiple high-grade silver-gold structures and demonstrate that higher grades occur across several drill sections rather than in a single isolated intercept. The ongoing program is now focused on establishing continuity and collecting the geological and structural information required for resource modelling. With APEX already engaged and actively advising on drill optimization, we are aligning each new hole with the objective of delivering a robust maiden NI 43-101 mineral resource estimate as the next step in this promising silver-gold discovery.”
Summary of Significant New Intercepts
Hole
From (m)
To (m)
Length (m)
Ag (g/t)
Au (g/t)
Area
Azimuth
Dip
25-UH-037
33
37
4
112.9
1.44
Target 01
327.14
-61.2
including
34
37
3
134.4
1.92
25-UH-041
19
23
4
125.7
0.14
Target 01
343.84
-51.99
including
22
23
1
452.0
0.50
25-UH-042
70
74
4
22.2
2.97
Target 03
130.25
-69.48
including
73
74
1
62.4
9.44
25-UH-043
16.8
18
1.2
316.3
0.30
Target 01
345
-70.35
25-UH-043
53
56
3
45.1
0.17
Target 01
including
53
53.45
0.45
180.5
0.85
25-UH-043
138
142.35
4.35
35.6
0.32
Target 01
including
141.35
142.35
1
73.5
1.19
26-UH-001
87.7
89
1.3
506.2
1.16
Target 01
342.3
-49.79
including
87.7
88.57
0.87
751.5
1.73
including
88.1
88.57
0.47
1089.0
2.67
26-UH-002
70
82.05
12.05
151.5
0.26
Target 01
345.86
-49.51
including
71.68
73.07
1.39
576.0
0.31
including
75.56
75.87
0.31
2960.0
8.23
26-UH-003
117.64
121.1
3.46
48.3
0.12
Target 01
166.7
-51.17
including
117.64
117.94
0.3
421.0
0.79
26-UH-004
64.45
90.55
26.1
77.8
0.14
Target 01
169.11
-50.5
including
64.45
64.75
0.3
3779.0
6.35
including
66.73
67.94
1.21
419.1
0.83
26-UH-004
152.75
154.85
2.1
178.5
0.51
Target 01
including
153.35
153.85
0.5
731.0
2.14
26-UH-005
92.85
94.18
1.33
93.1
0.28
Target 01
341.57
-50.7
including
93.34
93.74
0.4
231.0
0.74
26-UH-006
71
80.17
9.17
137.1
0.13
Target 01
344.54
-51.12
including
76
77.2
1.2
959.8
0.54
including
76.43
76.73
0.3
3656.0
1.99
26-UH-008
36.5
37.6
1.1
134.4
0.33
Target 01
340.49
-51.26
including
37.28
37.6
0.32
265.0
0.60
26-UH-009
36.94
39.17
2.23
421.9
0.95
Target 01
334.32
-51.18
including
37.82
39.17
1.35
695.8
1.35
including
38.85
39.17
0.32
2635.0
4.09
26-UH-012
263.1
265.4
2.3
56.5
0.30
Target 02
181.12
-46.82
including
264.7
265.4
0.7
129.0
0.86
Table 01. Summary of significant new mineralized intervals. The table presents 14 new Target 01, and significant silver and gold intervals from Targets 02 and 03. Composite grades are length weighted. All reported intervals in this news release are downhole core lengths. True widths of mineralized intervals are not known at this time.
Update To Previously Reported Results
Updated overlimit assays strengthen previously reported results from the December 2025 program. At Target 03, hole 25-UH-029 returned 2.00 m grading 624.0 g/t silver and 0.85 g/t gold from 27.00 to 29.00 m. At Target 02, the previously reported high-grade intercept in hole 25-UH-018 occurs within a broader 12.00 m interval grading 100.7 g/t silver and 0.51 g/t gold from 85.00 to 97.00 m. These are restated results and are not included in the table of new results above.
Figure 1. Map showing geology interpreted from geophysical data and satellite imagery, surface-sample assay results, drillhole collar locations, and identified target areas, with detailed views of recent drilling results from Target 01
The 2026 10,000-metre program is focused primarily on Target 01 and is intended to:
Test strike and dip continuity of the principal silver-gold structures;
Provide sufficient geological, structural, density and assay information to support three-dimensional wireframing and resource estimation;
Identify and close material drilling gaps while avoiding unnecessary duplication;
Improve confidence in the distribution of higher-grade shoots; and
Provide the technical basis for a maiden mineral resource estimate and NI 43-101 technical report
APEX has been appointed as the independent technical consultant for the mineral resource estimate and NI 43-101 technical report. APEX is presently reviewing results and interpretations and providing advice to optimize the remaining drill program for resource-estimation objectives.
Subsequent drilling will remain focused on Target 01 until the drilling required for the maiden resource estimate is completed. Following completion of the Target 01 resource-estimation program, the Company intends to return to Targets 02 and 03 for follow-up drilling and further evaluation of the mineralized structures identified to date.
Quality Assurance / Quality Control (QA/QC)
Drill core (HQ) samples were collected under the supervision of an experienced Silver Mining geologists and transported safely to a core logging facility for detailed logging and sampling. Samples were prepared using half core and securely shipped to Bureau Veritas Laboratories in Jeddah, Kingdom of Saudi Arabia for sample preparation, and analysis.
All samples were analyzed using four-acid digestion ICP-ES (code MA300) with Fire Assay and Gravimetric Finish (cores FA 430 and FA530, respectively) and standard industry procedures.
As part of the Company’s QA/QC protocols, a robust quality control program was implemented, which includes the insertion of certified reference materials (standards), blank samples, and duplicate samples at regular intervals (approximately every 10 samples) throughout the sample stream. All QA/QC control samples returned results within acceptable limits, ensuring the reliability of the assay data.
Qualified Person
The scientific and technical information in this news release has been reviewed and approved by Osbaldo Zamora, Ph.D., P.Geol., a Qualified Person as defined by National Instrument 43-101. Dr. Zamora is Vice President of Exploration for Kuya Silver and is not independent of the Company.
About Kuya Silver Corporation
Kuya Silver is a Canadian‐based, growth-oriented mining company with a focus on silver. Kuya Silver operates the Bethania silver mine in Peru, while developing district-scale silver projects in mining-friendly jurisdictions including Peru, Canada and Saudi Arabia.
About Silver Mining LLC
Silver Mining, based in the Kingdom of Saudi Arabia, is a private joint venture between majority shareholder, Saudi-based Sumou Holding (https://sumouholding.com), and Kuya Silver. Kuya Silver currently holds a 5% carried interest with an option to acquire an additional 40% participating interest in the company.
This news release contains statements that constitute “forward-looking information,” including statements regarding the plans, intentions, beliefs, and current expectations of the Company, its directors, or its officers with respect to the future business activities of the Company. The words “may,” “would,” “could,” “will,” “intend,” “plan,” “anticipate,” “believe,” “estimate,” “expect,” “must,” “next,” “propose,” “new,” “potential,” “prospective,” “target,” “future,” “verge,” “favorable,” “implications,” and “ongoing,” and similar expressions, as they relate to the Company or its management, are intended to identify such forward-looking information. Investors are cautioned that statements including forward-looking information are not guarantees of future business activities and involve risks and uncertainties, and that the Company’s future business activities may differ materially from those described in the forward-looking information as a result of various factors, including but not limited to fluctuations in market prices, successes of the operations of the Company, continued availability of capital and financing, and general economic, market, and business conditions. There can be no assurances that such forward-looking information will prove accurate, and therefore, readers are advised to rely on their own evaluation of the risks and uncertainties. The Company does not assume any obligation to update any forward-looking information except as required under the applicable securities laws.
Neither the Canadian Securities Exchange nor the Investment Industry Regulatory Organization of Canada accepts responsibility for the adequacy or accuracy of this release.
CALGARY, AB, Sept. 1, 2026 /CNW/ — InPlay Oil Corp. (TSX: IPO) (OTCQX: IPOOF) (“InPlay” or the “Company”) is pleased to confirm that its Board of Directors has declared a monthly cash dividend of $0.09 per common share payable on September 29, 2026, to shareholders of record at the close of business on September 15, 2026. The monthly cash dividend is expected to be designated as an “eligible dividend” for Canadian federal and provincial income tax purposes.
About InPlay Oil Corp.
InPlay is a junior oil and gas exploration and production company with operations in Alberta focused on light oil production. The company operates long-lived, low-decline properties with drilling development and enhanced oil recovery potential as well as undeveloped lands with exploration possibilities. The common shares of InPlay trade on the Toronto Stock Exchange under the symbol IPO and the OTCQX Exchange under the symbol IPOOF.
For further information please contact: Doug Bartole, President and Chief Executive Officer, InPlay Oil Corp., Telephone: (587) 955-0632; Darren Dittmer, Chief Financial Officer, InPlay Oil Corp., Telephone: (587) 955-0634
SAN DIEGO, Sept. 01, 2026 (GLOBE NEWSWIRE) — Kratos Defense & Security Solutions, Inc. (Nasdaq: KTOS), a technology company in defense, national security and global markets, announced today that it has been awarded a contract valued at more than $20 million to deliver mobile satellite communication (SATCOM) gateways for a defense customer in Asia.
Around the world, fixed communications infrastructure is becoming increasingly vulnerable to emerging threats. Recent conflicts and contested environments have shown that stationary SATCOM facilities can be easily targeted or disrupted, and modern operations often face denied spectrum and damaged public networks. These conditions highlight a critical need for defense organizations to deploy mobile SATCOM gateways that can maintain secure, reliable connectivity when traditional systems fail. With this capability, warfighters gain access to real‑time situational awareness and mission‑critical data where and when it matters most.
As part of the system, Kratos will deliver its rapid‑deployable, truck‑mounted Trifold® transportable antennas that can be deployed without any special tools and ready to discretely transport at a moment’s notice. These Trifold® antennas are integrated into the mobile SATCOM hub that provides high‑throughput, dependable communications in dynamic field environments.
The turnkey system also incorporates a shelter containing baseband platforms and advanced monitoring software, including Kratos’ Compass® product for complete monitor‑and‑control (M&C) of mission‑critical networks, and Kratos’ Monics® product for spectrum monitoring and interference detection, forming a cohesive and resilient mobile gateway tailored for defense operations.
This award strengthens Kratos’ position as a leader in transportable antennas and ground system technologies. The program also expands Kratos’ presence in the Asia-Pacific region and reinforces the company’s role as a trusted provider of advanced, resilient communications systems for defense applications worldwide.
“This capability is ultimately about giving operators on the ground what they need most: dependable communications they can count on in the middle of fast-moving missions,” said John Chay, Vice President of Business Development in Asia, at Kratos. “When fixed infrastructure is compromised, this mobile gateway lets warfighters stay connected, aware, and supported wherever the mission takes them.”
About Kratos Defense & Security Solutions Kratos Defense & Security Solutions, Inc. (NASDAQ: KTOS) is a technology, products, system and software company addressing defense, national security, and commercial markets. Kratos makes true internally funded research, development, capital and other investments, to rapidly develop, produce and field solutions that address our customers’ mission critical needs and requirements. At Kratos, affordability is a technology, and we seek to utilize proven, leading-edge approaches and technology, not unproven bleeding edge approaches or technology, with Kratos’ approach designed to reduce cost, schedule and risk, enabling us to be first to market with cost effective solutions. We believe that Kratos is known as an innovative disruptive change agent in the industry, a company that is an expert in designing products and systems up front for successful rapid, large quantity, low-cost future manufacturing which is a value-add competitive differentiator for our large traditional prime system integrator partners and also to our government and commercial customers. Kratos intends to pursue program and contract opportunities as the prime or lead contractor when we believe that our probability of win (PWin) is high and any investment required by Kratos is within our capital resource comfort level. We intend to partner and team with a large, traditional system integrator when our assessment of PWin is greater or required investment is beyond Kratos’ comfort level. Kratos’ primary business areas include virtualized ground systems for satellites and space vehicles including software for command & control and telemetry, tracking and control, jet powered unmanned aerial drone systems, hypersonic vehicles and rocket systems, propulsion systems for drones, missiles, loitering munitions, supersonic systems, space craft and launch systems, C5ISR and microwave electronic products for missile, radar, missile defense, space, satellite, counter unmanned aircraft systems, directed energy, communication and other systems, and virtual & augmented reality training systems for the warfighter. For more information, visit www.KratosDefense.com and follow Kratos on LinkedIn and X.
Notice Regarding Forward-Looking Statements Certain statements in this press release may constitute “forward-looking statements” within the meaning of the Private Securities Litigation Reform Act of 1995. These forward-looking statements are made on the basis of the current beliefs, expectations and assumptions of the management of Kratos and are subject to significant risks and uncertainty. Investors are cautioned not to place undue reliance on any such forward-looking statements. All such forward-looking statements speak only as of the date they are made, and Kratos undertakes no obligation to update or revise these statements, whether because of new information, future events or otherwise. Although Kratos believes that the expectations reflected in these forward-looking statements are reasonable, these statements involve many risks and uncertainties that may cause actual results to differ materially from what may be expressed or implied in these forward-looking statements. For a further discussion of risks and uncertainties that could cause actual results to differ from those expressed in these forward-looking statements, as well as risks relating to the business of Kratos in general, see the risk disclosures in the Annual Report on Form 10-K of Kratos for the year ended December 28, 2025, and in subsequent reports on Forms 10-Q and 8-K and other filings made with the Security and Exchange Commission by Kratos.
CULVER CITY, Calif., Sept. 01, 2026 (GLOBE NEWSWIRE) — Snail, Inc. (Nasdaq: SNAL) (“Snail Games” or the “Company”), a leading independent global developer and publisher of interactive digital entertainment, today announced that it has received a written decision from the Nasdaq Hearings Panel (the “Panel”) of The Nasdaq Stock Market LLC (“Nasdaq”) granting the Company’s request to continue listing its Class A Common Stock, par value $0.0001 per share (the “Class A Common Stock”) on The Nasdaq Capital Market, subject to the Company demonstrating compliance with Nasdaq Listing Rule 5550(b) by obtaining a minimum stockholders’ equity of at least $2,500,000 (the “Equity Rule”) within a prescribed time period and filing timely public disclosure (i) describing the transactions undertaken by the Company to achieve such compliance and demonstrate long long-term compliance with the Equity Rule and (ii) providing an indication of its equity following those transactions.
The Panel’s decision also requires the Company to provide prompt notification of any significant events occurring during the prescribed time period that may affect the Company’s compliance with Nasdaq requirements, including any event that may call into question the Company’s ability to meet the terms of the Panel’s decision. The Panel has reserved the right to reconsider the terms of its decision based on any event, condition or circumstance that exists or develops that would, in the opinion of the Panel, make continued listing of the Company’s securities on Nasdaq inadvisable or unwarranted. The foregoing summarizes certain terms of the Panel’s decision and does not describe all of the terms and conditions of the decision.
The Company’s Class A Common Stock will continue to be listed and traded on The Nasdaq Capital Market under the symbol “SNAL” during the prescribed time period, subject to the Company’s satisfaction of the conditions set forth in the Panel’s decision. The Company is working to regain compliance with the Equity Rule. Any compliance submission by the Company will be subject to review by the Panel. There can be no assurance that the Company will satisfy the conditions of the Panel’s decision or otherwise regain compliance with the applicable listing requirements, and a failure to do so would result in the delisting of the Company’s securities from Nasdaq.
About Snail, Inc.
Snail, Inc. (Nasdaq: SNAL) is a leading global independent developer and publisher of interactive digital entertainment for consumers around the world, with a premier portfolio of premium games designed for use on a variety of platforms, including consoles, PCs, and mobile devices. For more information, please visit: https://snail.com/.
Forward-Looking Statements
This press release contains statements that constitute forward-looking statements. Many of the forward-looking statements contained in this press release can be identified by the use of forward-looking words such as “anticipate,” “believe,” “could,” “expect,” “should,” “plan,” “intend,” “may,” “predict,” “continue,” “estimate” and “potential,” or the negative of these terms or other similar expressions. These forward-looking statements include information about possible or assumed future results of Snail Games’ business, financial condition, results of operations, liquidity, plans and objectives. Forward-looking statements appear in a number of places in this press release and include, but are not limited to, statements regarding the Company’s satisfaction of the conditions set forth in the Panel’s decision and demonstrating compliance with the Nasdaq Listing Rules, including Nasdaq Listing Rule 5550(b), and filing any related public disclosures; the Company providing notifications to Nasdaq of any significant events occurring in the future and such events’ effect on the Company’s compliance with Nasdaq requirements; the Panel’s potential reconsideration of the terms of its decision; the Company’s Class A Common Stock continuing to be listed and traded on The Nasdaq Capital Market; and the consequences of any failure to regain compliance with applicable listing requirements; and assumptions underlying any of the foregoing. Further information on risks, uncertainties and other factors that could affect Snail Games’ financial results and business is included in its filings with the Securities and Exchange Commission (the “SEC”) from time to time, including its ability to demonstrate compliance with Nasdaq Listing Rule 5550(b) within the prescribed time period and the other risk factors set forth in its most recent annual report on Form 10-K and subsequent quarterly reports on Form 10-Q filed, or to be filed, with the SEC. You should not rely on these forward-looking statements, as actual outcomes and results may differ materially from those expressed or implied in the forward-looking statements as a result of such risks and uncertainties. All forward-looking statements in this press release are based on management’s beliefs and assumptions and on information currently available to Snail Games, and Snail Games does not assume any obligation to update the forward-looking statements provided to reflect events that occur or circumstances that exist after the date on which they were made.
Investor Contact:
John Yi and Steven Shinmachi Gateway Group, Inc. 949-574-3860 [email protected]
Saguenay, Québec–(Newsfile Corp. – September 1, 2026) – First Phosphate Corp (NASDAQ: PHOS) (CSE: PHOS) (OTCQX: FRSPF) (FSE: KD0) (“First Phosphate” or the “Company“) is pleased to report the voting results for the Company’s Annual General and Special Meeting of Shareholders (the “Meeting“) held on August 28, 2026.
Voting Results
Detailed voting results of the election of the Company’s board of directors (the “Board“) are set out below:
Nominee
Votes For
% For
Votes Withheld
% Withheld
John Passalacqua
65,681,593
99.52%
317,515
0.48%
Laurence W. Zeifman
63,839,049
96.73%
2,160,059
3.27%
Bennett Kurtz
65,673,958
99.51%
325,150
0.49%
Peter Nicholson
65,691,489
99.53%
307,619
0.47%
Peter Kent
64,335,301
97.48%
1,663,807
2.52%
All nominees, as set forth in the Company’s Management Information Circular dated July 29, 2026 (the “Circular“), were elected as directors of First Phosphate at the Meeting.
At the Meeting, shareholders also approved: (1) the number of directors to be fixed at five, (2) the appointment of Davidson & Company LLP as auditor of the Company for the ensuing year and authorizing the Board to fix the remuneration of the auditor, (3) the Company’s advance notice policy (the “Policy“); and (4) the re-approval of the Company’s omnibus equity incentive plan, all as more particularly described in the Circular.
Matter
Votes For
% For
Votes Against – Withheld
% Against – Withheld
Number of directors
65,594,446
99.39%
404,662
0.61%
Appointment of auditors
64,206,061
97.28%
1,793,047
2.72%
Advance Notice Policy
64,112,942
97.14%
1,886,166
2.86%
Re-Approve Equity Incentive Plan
63,654,831
96.45%
2,344,277
3.55%
For further information regarding the matters considered at the Meeting, readers are encouraged to review the Circular, a copy of which is available under the profile for the Company on SEDAR+ (www.sedarplus.ca).
Increase in Shareholder Base
The Company is pleased to announce that its shareholders on record for the 2026 Meeting increased by 861% over the 2025 Meeting. The total registered shareholders reported are based on the registrar of the Company’s transfer agent plus beneficial shareholders reported by Broadridge.
AGM Record Date
Shareholders
2026
12,501
2025
1,301
2024
861
2023
800
2022
307
The Company believes that this increase in shareholders represents a positive sign of maturation in the Company’s corporate development, one that can be attributed to successful financings, management’s commitment to results, and a broader understanding and appreciation of the Company’s vision, initiatives and opportunities, among both retail and institutional investors.
Advance Notice Policy
The Board has, effective immediately, adopted the Policy which, among other things, and subject to certain exceptions, sets forth a procedure requiring advance notice to the Company by any shareholder who intends to nominate any person for election as director of the Company at a meeting of shareholders at which directors are to be elected. For additional details, please consult the full text of the Policy included in the Circular.
The Board believes that the Policy provides a clear and transparent process for all shareholders to follow, if they intend to nominate directors, by providing a reasonable time frame for shareholders to notify the Company of their intention to nominate directors and requiring shareholders to disclose information concerning proposed nominees that is mandated by applicable securities laws.
The Policy enables the Board to evaluate the proposed nominees’ qualifications and suitability as directors and respond as appropriate in the best interests of the Company.
About First Phosphate Corp
First Phosphate (NASDAQ: PHOS) (CSE: PHOS) (OTCQX: FRSPF) (FSE: KD0) is a mineral exploration and development and clean technology company dedicated to building and reshoring a vertically integrated mine-to-market supply chain for the production of LFP batteries in North America. Target markets include energy storage, data centers, robotics, mobility, and national security. First Phosphate’s flagship Bégin-Lamarche property, located in Saguenay-Lac-Saint-Jean, Québec, Canada, represents a rare North American igneous phosphate resource producing high-purity phosphate characterized by very low levels of impurities.
Forward-Looking Information and Cautionary Statements
This news release contains certain statements and information that may be considered “forward-looking statements” and “forward looking information” within the meaning of applicable securities laws. In some cases, but not necessarily in all cases, forward-looking statements and forward-looking information can be identified by the use of forward-looking terminology such as “plans”, “targets”, “expects” or “does not expect”, “is expected”, “an opportunity exists”, “is positioned”, “estimates”, “intends”, “assumes”, “anticipates” or “does not anticipate” or “believes”, or variations of such words and phrases or statements that certain actions, events or results “may”, “could”, “would”, “might”, “will” or “will be taken”, “occur” or “be achieved” and other similar expressions. In addition, statements in this news release that are not historical facts are forward looking statements. Although the Company believes the expectations expressed in such forward-looking statements are based on reasonable assumptions, such statements are not guarantees of future performance and actual results or developments may differ materially from those forward-looking statements. Factors that could cause actual results to differ materially from those in forward-looking statements include development and exploration successes, continued availability of capital and financing, and general economic, market or business conditions. These statements are based on a number of assumptions including, among other things: that engineering and construction timetables and capital costs for the Company’s, exploration, development and expansion projects are correctly estimated and not affected by unforeseen circumstances; the ability to obtain financing for its proposed operations on acceptable terms; no material deterioration in general business and economic conditions; no material delays in obtaining permits and other approvals; no significant disruptions affecting the activities of the Company or its ability to access required project equipment and services, and operating supplies in sufficient quantities and on a timely basis; inflation and prices for Company project inputs being approximately consistent with anticipated levels; the ability to complete the exploration and development programs consistent with the Company’s expectations; commodity price expectations including assumptions for P2O5; the Company’s relationship with local municipalities and First Nations remaining consistent with the Company’s expectations; the Company’s relationship with other third-party partners and suppliers remaining consistent with the Company’s expectations; and government relations and actions being consistent with Company expectations. Investors are cautioned that any such statements are not guarantees of future performance and actual results or developments may differ materially from those projected in the forward-looking statements. Accordingly, readers should not place undue reliance on the forward-looking information contained in this press release. The Company does not assume any obligation to update or revise its forward-looking statements, whether because of new information, future events or otherwise, except as required by applicable law. All forward-looking information contained in this release is qualified by these cautionary statements.
The single global Phase 3 trial, ArMaDa3 (NCT07770828), is the first pivotal gene therapy trial in geographic atrophy (GA)
U.S. Food and Drug Administration (FDA) granted OCU410 Regenerative Medicine Advanced Therapy (RMAT) designation, providing enhanced agency engagement throughout development and eligibility for accelerated approval and priority review
Phase 3 design fully aligned with FDA; Biologics License Application (BLA) filing anticipated in 2028
OCU410 is designed as a one-time subretinal gene therapy that addresses multiple disease pathways, offering a differentiated approach from approved complement inhibitors in the U.S. which address individual disease pathways and require ongoing intravitreal injections
MALVERN, Pa., Sept. 01, 2026 (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 was dosed in the global Phase 3 registrational trial of OCU410 (AAV5-hRORA), its first-in-class modifier gene therapy candidate for GA secondary to dry age-related macular degeneration (dAMD). The Company also highlighted the recent FDA RMAT designation for OCU410, which supports a potential accelerated development and review pathway for the program.
“Dosing the first patient in our global Phase 3 trial, just weeks after receiving RMAT designation, marks a defining moment for the OCU410 program – and for the millions of people living with geographic atrophy. Outside the U.S., there are currently no approved treatments for GA, while in the U.S., available treatment options address only one of the four disease pathways and require ongoing, repeated eye injections,” said Dr. Shankar Musunuri, Chairman, Chief Executive Officer, and Co-Founder of Ocugen. “This is our third modifier gene therapy program to advance into late-stage development, demonstrating the strength of our platform and our vision for potentially delivering a one-time treatment for life.”
The initiation of dosing follows the successful completion of a Type B End-of-Phase 2 (EOP2) meeting with FDA’s Center for Biologics Evaluation and Research (CBER) in July 2026, resulting in alignment on all critical Phase 3 design elements, including primary and secondary endpoints, dose, adaptive design, and a single pivotal trial pathway to support a BLA.
“We are entering a global single Phase 3 with a well-defined program: a dose validated in a randomized, controlled Phase 2 study; an FDA-endorsed primary endpoint measuring the rate of lesion growth; and a secondary endpoint assessing functional vision,” said Mohamed Genead, MD, Chief Medical Officer of Ocugen. “The Phase 3 program builds on compelling 12-month Phase 2 data, which demonstrated a statistically significant 31% reduction in lesion growth with the optimal dose compared with control following a single subretinal injection, along with concordant preservation of the ellipsoid zone and no drug-related serious adverse events (SAEs) or adverse events of special interest (AESIs).”
OCU410 delivers the human retinoid-related orphan receptor alpha (RORA) modifier gene via a single subretinal injection of an AAV5 vector. Unlike therapies targeting a single pathway, OCU410 is designed to simultaneously address multiple pathophysiological drivers of GA-complement overactivation, chronic inflammation, oxidative stress, and lipid dysregulation. GA affects approximately 2–3 million people in the U.S. and Europe and is a leading cause of irreversible central vision loss in older adults, with prevalence expected to rise as the population ages.
According to study investigator Victor Gonzalez, MD, “Patients with geographic atrophy continue to face irreversible structural and functional loss of the retina, along with limited treatment options. The OCU410 Phase 3 study provides an important opportunity to evaluate a novel, potential one-time gene therapy approach that could lessen the burden of current treatments in the U.S., which require patients to undergo multiple injections every year.”
Global Phase 3 Registrational Trial Design The Phase 3 trial is a global, multicenter, randomized, controlled study enrolling 237 subjects with GA secondary to dAMD, randomized 2:1 to a single 200 µL subretinal injection of OCU410 (5×1010 vg/mL) or an untreated control arm, with sites in the United States, Canada, Europe, and Latin America.
Primary endpoint: Rate of change of square root-transformed GA lesion area (√mm²/year) by fundus autofluorescence (FAF) at baseline, Month 4, Month 8, and Month 12, analyzed by MMRM.
Secondary endpoints: Proportion of subjects with Low-Luminance Visual Acuity (LLVA) loss ≥15 ETDRS letters at two consecutive visits through Month 12, providing a functional vision anchor to the primary anatomic endpoint; and rate of change of ellipsoid zone (EZ) area loss by SD-OCT.
Regulatory path: A single, adequate and well-controlled Phase 3 trial, aligned with FDA feedback, is intended to support a BLA filing anticipated in 2028. Discussions are ongoing with the European Medicines Agency (EMA) regarding alignment to potentially support a marketing authorization application (MAA) in Europe with this single Phase 3 trial.
RMAT Designation: Regulatory and Strategic Significance On July 29, 2026, FDA granted RMAT designation to OCU410 based on Phase 2 clinical data demonstrating clinically meaningful efficacy and a favorable safety profile, with no serious adverse events related to OCU410 reported. RMAT designation is granted to regenerative medicine therapies intended to treat serious or life-threatening conditions where preliminary clinical evidence indicates the potential to address an unmet medical need.
For the OCU410 program, RMAT designation provides:
Eligibility for accelerated approval and priority review, which may compress the time from BLA submission to potential market entry.
All benefits of Breakthrough Therapy designation, including intensive FDA guidance on efficient development and organizational commitment involving senior FDA leadership.
Early and frequent FDA interactions on the use of surrogate and intermediate clinical endpoints reasonably likely to predict long-term clinical benefit-directly relevant to OCU410’s FAF-based anatomic primary endpoint.
Potential flexibility in satisfying post-approval requirements, including through expanded patient registries or real-world evidence.
Taken together with FDA alignment on the Phase 3 design and the initiation of dosing, RMAT designation further de-risks the regulatory pathway for OCU410 and reinforces the differentiation of a one-time, multi-pathway gene therapy in a GA market currently served only by chronically administered intravitreal complement inhibitors.
Supporting Phase 2 ArMaDa Data The Phase 3 trial and the RMAT designation are supported by 12-month data from the Phase 2 ArMaDa trial (NCT06018558), a multicenter, randomized, controlled study of 51 subjects with GA secondary to dAMD.
Lesion growth (FAF): 31% reduction in GA lesion area growth rate in the medium dose group versus control at 12 months (p < 0.05) in the pivotal phase 3 population (lesion size of ≥2.5 mm2 and ≤17.5 mm2), a potential 2× treatment benefit relative to the 15% and 22% reductions reported for currently approved therapies in the U.S. at 12 and 24 months, respectively.
EZ preservation (SD-OCT): 27% reduction in ellipsoid zone area loss in the medium dose group versus control, a structural correlate of visual function.
Responder analysis: In the medium dose group, approximately 20% of treated subjects showed no disease progression; 75% demonstrated >30% reduction in lesion growth at 12 months.
Safety: No OCU410-related serious adverse events (SAEs) or adverse events of special interest (AESIs) reported to date.
About OCU410 OCU410 (AAV5-hRORA) is Ocugen’s investigational first-in-class modifier gene therapy, delivering the RORA gene via a single unilateral subretinal injection to regulate complement activation, neuroinflammation, oxidative stress, and lipid metabolism – multiple pathways implicated in the pathogenesis of GA. OCU410 has received RMAT designation from the FDA and Advanced Therapy Medicinal Product classification from the European Medicines Agency’s Committee for Advanced Therapies.
About Ocugen, Inc. Ocugen, Inc. is a pioneering biotechnology company developing gene therapies for blindness diseases. The Company’s breakthrough modifier gene therapy platform has the potential to address significant unmet medical needs across large patient populations through a gene-agnostic approach. Unlike traditional gene therapies and gene-editing technologies that target a single gene mutation, Ocugen’s modifier gene therapies are designed to address the underlying disease biology by restoring balance across multiple gene networks. The Company is currently advancing programs for inherited retinal diseases and other causes of blindness that affect millions worldwide, including retinitis pigmentosa, Stargardt disease, and geographic atrophy, an advanced form of dry age-related macular degeneration. Discover more at www.ocugen.com and follow us on LinkedIn and X.
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 strategy, business plans and objectives for Ocugen’s clinical programs, plans and timelines for the preclinical and clinical development of Ocugen’s product candidates, including the therapeutic potential, clinical benefits and safety thereof, expectations regarding timing, success and data announcements of current ongoing preclinical and clinical trials, including the timing of enrollment and data readouts, the ability to initiate new clinical programs, statements regarding qualitative assessments of available data, potential benefits, expectations for ongoing clinical trials, anticipated regulatory filings and anticipated development timelines, statements regarding potential market size and commercial possibilities of Ocugen’s product candidates, 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 receipt of RMAT designation may not lead to faster development or accelerated regulatory review or approval; that preliminary, interim and top-line clinical trial results may not be indicative of, and may differ from, final clinical 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 may not be predictive of the results or success of later clinical trials; and 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 annual and quarterly 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.
Three-part program – AI-enabled characterization of PrimeC’s formulation advantage, an active-comparator trial against edaravone, and a streamlined pivotal pathway – is designed to strengthen PrimeC’s differentiation, shorten the time to potential commercialization, and significantly reduce overall development costs, complemented by a parallel regulatory pathway in Canada.
CAMBRIDGE, Mass., Aug. 31, 2026 /PRNewswire/ — NeuroSense Therapeutics Ltd. (NASDAQ: NRSN) (“NeuroSense”), a late-stage clinical biotechnology company focused on developing disease-modifying treatments for neurodegenerative diseases, today announced a redesigned development plan for PrimeC in amyotrophic lateral sclerosis, structured to reach a potential path for regulatory submission and approval faster and at materially lower cost than the Company’s previously planned development path.
ALS drug development has been shaped by a single model: large, long, expensive confirmatory trials that few companies can fund and that people with ALS wait years to read out. NeuroSense’s plan replaces that single large commitment with three shorter, focused studies, each designed to answer a specific question that regulators, physicians, partners or payers routinely ask.
The redesigned strategy builds on the totality of evidence generated in NeuroSense’s Phase 2b PARADIGM study, including clinically meaningful effects on functional decline, statistically significant modulation of extracellular vesicle-associated TDP-43, consistent findings across multiple disease-related biomarkers, and encouraging long-term survival results. NeuroSense has already received FDA clearance to initiate its pivotal Phase 3 PARAGON trial. Together, these clinical, biomarker and regulatory advances provide the foundation for a more focused and capital-efficient development pathway.
AI-enabled characterization of PrimeC’s formulation advantage. PrimeC is an extended-release fixed-dose combination engineered to synchronize the pharmacokinetic profiles of its two active components. In a completed clinical pharmacokinetic study, PrimeC produced a synchronized exposure profile that was not reproduced when the individual components were administered together. NeuroSense is now applying AI-enabled modeling to these clinical data to quantify the magnitude of that difference, assess its consistency across individual patients and further characterize the contribution of PrimeC’s proprietary formulation. This work builds upon PrimeC’s established intellectual property position and is intended to support potential additional patent protection while providing clinicians, payers and prospective partners with an objective basis for distinguishing PrimeC from any co-administration of its individual components.
A direct comparative study against edaravone. NeuroSense plans to conduct an active-comparator clinical study designed to evaluate PrimeC directly against edaravone, an established ALS therapy. Head-to-head trials are not common in ALS, and differentiated results could provide people with ALS, clinicians, payers and prospective partners with compelling evidence of PrimeC’s relative clinical value and commercial potential.
A streamlined pivotal pathway. NeuroSense is evaluating an optimized design for its planned Phase 3 study (PARAGON) that would be substantially smaller and shorter in duration than previously planned, enriched for participants earlier in their disease course and intended to support an earlier regulatory submission. Any such pivotal design remains subject to alignment with FDA. The Company plans to discuss with the FDA whether its existing data may support full approval or, alternatively, an Accelerated Approval pathway, with an additional study conducted post-approval as required.
A parallel path to earlier access in Canada. NeuroSense has completed the pre-New Drug Submission process with Health Canada and is preparing a New Drug Submission for PrimeC, which the Company continues to target for December 2026. If accepted and ultimately approved, this pathway has the potential to make PrimeC available to Canadian patients on the strength of data already generated.
“One of the hardest constraints in ALS is not scientific – it is that the standard development path takes longer than patients have,” said Alon Ben-Noon, Co-Founder and Chief Executive Officer of NeuroSense. “We have asked a straightforward question: what is the shortest reasonable route from the data we already hold to a therapy people can actually receive? This plan is our answer. It is faster, it costs less, and it produces a stronger package – pharmacology, comparative clinical context, and a pivotal dataset – than the single-trial approach would have.”
About NeuroSense
NeuroSense Therapeutics is a late-clinical stage biotechnology company developing novel treatments for severe neurodegenerative diseases, including amyotrophic lateral sclerosis (ALS) and Alzheimer’s disease. The Company’s lead product candidate, PrimeC, is a novel oral therapy designed to target multiple key biological pathways underlying disease progression, including neuroinflammation, oxidative stress and dysregulated iron metabolism.
NeuroSense has recently completed analysis of long-term follow-up data from its Phase 2b PARADIGM study in ALS, with results published in JAMA Neurology showing slowing of functional decline relative to placebo. The Company also reported changes across multiple biomarkers associated with ALS, including microRNAs, consistent with PrimeC’s multi-target mechanism of action.
NeuroSense has received clearance from the U.S. Food and Drug Administration (FDA) to initiate its pivotal Phase 3 clinical trial (PARAGON) in ALS, to be conducted primarily in the United States. As described above, the Company is working with FDA on an optimized design for the study.
For additional information, we invite you to visit our website and follow us on LinkedIn, YouTube and X. Information that may be important to investors may be routinely posted on our website and these social media channels.
About PrimeC
PrimeC, NeuroSense’s lead drug candidate, is a novel extended-release oral formulation composed of a unique fixed-dose combination of two FDA-approved drugs: ciprofloxacin and celecoxib. PrimeC is designed to target several key mechanisms that contribute to neuron degeneration, inflammation, iron accumulation and impaired ribonucleic acid (“RNA”) regulation, with the potential to inhibit disease progression.
About ALS
Amyotrophic lateral sclerosis (“ALS”) is an incurable neurodegenerative disease that causes complete paralysis and death within 3 years from diagnosis. Every year, more than 5,000 people are diagnosed with ALS in the U.S. alone, with an annual disease burden of $1 billion. The number of people living with ALS is expected to grow by 24% by 2040 in the U.S. and EU.
Forward-Looking Statements
This press release contains “forward-looking statements” that are subject to substantial risks and uncertainties. All statements, other than statements of historical fact, contained in this press release are forward-looking statements. Forward-looking statements contained in this press release may be identified by the use of words such as “anticipate,” “believe,” “contemplate,” “could,” “estimate,” “expect,” “intend,” “seek,” “may,” “might,” “plan,” “potential,” “predict,” “project,” “target,” “aim,” “should,” “will,” “would,” or the negative of these words or other similar expressions, although not all forward-looking statements contain these words. Forward-looking statements are based on NeuroSense Therapeutics’ current expectations and are subject to inherent uncertainties, risks and assumptions that are difficult to predict and include statements regarding the potential benefits of the Company’s redesigned development strategy for PrimeC. Further, certain forward-looking statements, including statements regarding the potential regulatory pathways for PrimeC, are based on assumptions as to future events that may not prove to be accurate. The future events and trends may not occur and actual results could differ materially and adversely from those anticipated or implied in the forward-looking statements. These risks include the potential for delay in the timing of the Phase 3 clinical trial (PARAGON) in ALS; potential delay in the Canadian New Drug Submission; the risk that the Company will not be able to obtain financing on acceptable terms, or at all; the risk that the Company will not regain and maintain compliance with the Nasdaq listing requirements; the risk that the strategic opportunities described will not materialize or result in the anticipated benefits to the Company; uncertainty regarding outcomes and the timing of current and future clinical trials; the risk that PrimeC will not advance towards later-stage development; timing for reporting data, including from the study of PrimeC in Alzheimer’s disease; that the study will not be successful; and other risks and uncertainties set forth in NeuroSense’s filings with the Securities and Exchange Commission (SEC). You should not rely on these statements as representing our views in the future. More information about the risks and uncertainties affecting NeuroSense is contained under the heading “Risk Factors” in the Annual Report on Form 20-F filed with the Securities and Exchange Commission on March 31, 2026 and NeuroSense’s subsequent filings with the SEC. Forward-looking statements contained in this announcement are made as of this date, and NeuroSense undertakes no duty to update such information except as required under applicable law.
For further information: Email: [email protected] | Tel: +972 (0)9 799 6183
FDA Alignment on Primary Endpoint and Path Forward for Phase 3 Registration Study
CAD-1005 Targets a Significant Unmet Need, with Approximately 50,000 Confirmed Acute HIT Diagnoses Annually in the U.S. and an Estimated $2 Billion in Peak Annual Revenue Opportunity
PONTE VEDRA, Fla., Aug. 31, 2026 (GLOBE NEWSWIRE) — Cadrenal Therapeutics, Inc. (Nasdaq: CVKD), a late-stage biopharmaceutical company advancing specialized therapies for critical care cardiology and orphan cardiovascular conditions, today announced positive feedback from a Type D Meeting with the U.S. Food and Drug Administration (FDA) held on July 28, 2026. During the meeting, Cadrenal and the FDA aligned on key aspects of the protocol and Statistical Analysis Plan (SAP) for the Phase 3 registrational study of CAD-1005, the Company’s first-in-class 12-lipoxygenase (12-LOX) inhibitor in development to treat heparin-induced thrombocytopenia (HIT). HIT is a potentially life-threatening immune reaction to heparin, a widely used blood thinner, and can lead to dangerous blood clots.
In the U.S., heparin-induced thrombocytopenia (HIT) is a high-stakes emergency that affects approximately 50,000 patients with acute HIT each year. Current therapeutic options rely on standard anticoagulants to reduce thrombotic risk; however, they do not target the underlying immune mechanisms that drive this destructive cardiovascular cascade. CAD-1005 is a novel 12-LOX inhibitor designed to halt the core immune signaling pathway that drives platelet activation and vascular thrombosis. Developed as an essential add-on to standard anticoagulation, CAD-1005 targets a critical population and is projected to generate $2 billion in peak annual revenue.
During the Type D meeting, the FDA agreed on an optimized definition of worsening HIT for the primary endpoint, based on progression of thrombotic events through Day 14 of treatment or hospital discharge. To ensure high-quality, reliable endpoint evaluation across clinical sites, the worsening component of the primary endpoint will also include extension of an existing thrombus into a new vascular segment or bed, avoiding potential site-to-site variability from manual size measurements. The updated composite primary endpoint will measure the proportion of Serotonin Release Assay-positive (SRA+) participants with adjudicated new or worsening composite thromboembolic events (CTEs) through Day 14 or hospital discharge. Additionally, the FDA agreed to use placebo control in the Phase 3 trial, with standard anticoagulation therapeutics for both the CAD-1005 and placebo control arms.
“We are very pleased with the collaborative, constructive feedback from the FDA during this Type D meeting,” said Quang X. Pham, Chief Executive Officer of Cadrenal Therapeutics. “Securing agreement on the primary endpoint definition and the blinding protocols for our saline control provides greater clarity on the regulatory path forward for CAD-1005. We have incorporated the Agency’s recommendations into our Phase 3 protocol and Statistical Analysis Plan, strengthening the design of a registration study intended to evaluate whether CAD-1005 can reduce dangerous thrombotic events that persist in patients with HIT despite current anticoagulant therapies.”
The Phase 3 trial design will also assess bleeding as a major safety endpoint using standard International Society on Thrombosis and Haemostasis (ISTH) criteria. All safety analyses will be conducted in the safety population of patients who receive at least one dose of the study drug.
About Cadrenal Therapeutics, Inc.
Cadrenal Therapeutics, Inc. is a late-stage biopharmaceutical company advancing specialized therapies for critical care cardiology and orphan cardiovascular conditions. The Company’s pipeline includes CAD-1005, tecarfarin, and frunexian. CAD-1005 is a novel investigational therapeutic in development for the treatment of heparin-induced thrombocytopenia (HIT) and Cardiac Surgery-Associated Acute Kidney Injury (CSA-AKI). CAD-1005 is designed to selectively inhibit 12-lipoxygenase (12-LOX), an enzyme central to platelet immune activation and thrombo-inflammatory signaling in HIT. CAD-1005 is intended to be used alongside existing standards of care and is being developed to address the underlying biological mechanisms that drive disease progression. CAD-1005 has an Orphan Drug Designation (“ODD”) from the U.S. Food and Drug Administration (“FDA”) for prophylaxis of thrombosis in patients with HIT, FDA Fast Track designation for the treatment and prevention of HIT, and an orphan designation from the European Medicines Agency for the treatment of platelet-activating factor 4 disorders. Second-generation 12-LOX oral therapeutics (CAD-2000) are also in development for chronic indications.
The Company’s broader pipeline includes tecarfarin, a late-stage oral vitamin K antagonist designed to prevent heart attacks, strokes, and deaths from blood clots in patients requiring chronic anticoagulation, including those with end-stage kidney disease and atrial fibrillation, those with left ventricular assist devices, and potentially those with Kawasaki disease (KD), an acute, self-limited, febrile illness that primarily affects children under 5 years old and is the leading cause of acquired heart disease in developed countries. The Company recently submitted a request to the FDA for Rare Pediatric Disease Designation (RPDD) for tecarfarin for “Prevention of the Formation of Life-Threatening Blood Clots Inside Coronary Artery Aneurysms in Children with Kawasaki Disease”. Tecarfarin has also received Orphan Drug and Fast Track designations from the FDA.
For more information, visit https://www.cadrenal.com/ and connect with the Company on LinkedIn.
Safe Harbor
Any statements in this press release about future expectations, plans, and prospects, as well as any other statements regarding matters that are not historical facts, may constitute “forward-looking statements.” The words “anticipate,” “believe,” “continue,” “could,” “estimate,” “expect,” “intend,” “may,” “plan,” “potentially,” “predict,” “project,” “should,” “target,” “will,” “would” and similar expressions are intended to identify forward-looking statements, although not all forward-looking statements contain these identifying words. These statements include, without limitation, statements regarding the planned Phase 3 registration study of CAD-1005, the development of CAD-1005 to treat HIT; CAD-1005 potentially halting the core immune signaling pathway that drives platelet activation and vascular thrombosis; CAD-1005 being an essential add-on to standard anticoagulation; CAD-1005 unlocking a projected $2 billion in peak annual revenue; the worsening component of the primary endpoint of optimized definition of worsening HIT assessing extension of an existing thrombus into a new vascular segment or bed, avoiding potential site-to-site variability from manual size measurements; the updated composite primary endpoint measuring the proportion of Serotonin Release Assay-positive (SRA+) participants with adjudicated new or worsening composite thromboembolic events (CTEs) through Day 14 or hospital discharge; the regulatory path forward for CAD-1005; the registration study evaluating whether CAD-1005 can reduce dangerous thrombotic events that continue to occur in patients with HIT despite current anticoagulant therapies; the Phase 3 trial design evaluating bleeding as a major safety endpoint using standard International Society on Thrombosis and Haemostasis (ISTH) criteria; all safety analyses in the Phase 3 trial being conducted in the true safety population of patients who receive at least one dose of the study drug; the Company advancing specialized therapies for critical care cardiology and orphan cardiovascular conditions; CAD-1005 being successfully developed to treat HIT and CSA-AKI; CAD-1005 selectively inhibiting 12-LOX, an enzyme central to platelet immune activation and thrombo-inflammatory signaling in HIT; CAD-1005 being intended to be used alongside existing standards of care and being developed to address the underlying biological mechanisms that drive disease progression; second-generation 12-LOX oral therapeutics (CAD-2000) being developed for chronic indications; tecarfarin, a late-stage oral vitamin K antagonist, potentially preventing heart attacks, strokes, and deaths from blood clots in patients requiring chronic anticoagulation, including those with end-stage kidney disease and atrial fibrillation, those with left ventricular assist devices, and potentially those with Kawasaki disease; and the FDA’s ultimate decision regarding the Company’s request for RPDD for tecarfarin for the prevention of life-threatening blood clots inside coronary artery aneurysms in children with Kawasaki Disease; Actual results may differ materially from those indicated by such forward-looking statements as a result of various important factors, including the Company’s ability to advance its programs to clinical trial readiness; the Company’s ability to enter into development, licensing, and commercialization transactions for CAD-1005, frunexian, and tecarfarin; the Company’s ability to secure nondilutive grants to advance its programs; and the other risk factors described in the Company’s Annual Report on Form 10-K for the year ended December 31, 2025, and the Company’s subsequent filings with the Securities and Exchange Commission, including subsequent periodic reports on Quarterly Reports on Form 10-Q and Current Reports on Form 8-K. Any forward-looking statements contained in this press release speak only as of the date hereof and, except as required by federal securities laws, the Company specifically disclaims any obligation to update any forward-looking statement, whether as a result of new information, future events, or otherwise.
SAN DIEGO, Aug. 31, 2026 (GLOBE NEWSWIRE) — Kratos Defense & Security Solutions, Inc. (Nasdaq: KTOS), a technology company in defense, national security, and global markets, today announced that it recently received an approximate $35 million National Security-related military-grade hardware production program award. It is expected that the hardware and related systems being produced and supported under this recent award will be in direct support of the warfighter in the field.
Kratos is an industry leader in the engineering, design, development and production of military grade hardware and systems in support of the United States and its Allies’ mission critical national security priorities. Kratos is currently in large-scale production in support of multiple national security related systems and programs of record, including in the areas of hypersonics, counter-unmanned aerial systems, air defense, missiles, radars, and high-powered directed energy and other initiatives.
Tom Mills, President of Kratos C5ISR, said, “Kratos is a recognized industry leader in the engineering and large-scale production of military grade hardware in support of certain of the United States’ and its allies’ most important National Security programs and initiatives. If a customer wants its product or system engineered correctly up front, for successful, on-schedule, on-budget production, we believe that we are the preferred, go to partner.”
Eric DeMarco, Kratos’ President and CEO, said, “Kratos’ C5ISR Business is a crown jewel of Kratos and a national asset for our country. Kratos has the workforce, infrastructure, technical capability and past performance qualifications to successfully complete the mission and engineer and build mil-spec hardware and weapon systems correctly the first time for our partners and customers.”
Work under this program award will be performed at a secure Kratos facility. Due to customer, National Security related and other considerations, no additional information will be provided related to this contract award.
About Kratos Defense & Security Solutions Kratos Defense & Security Solutions, Inc. (Nasdaq: KTOS) is a technology, products, system and software company addressing the defense, national security, and global markets. Kratos makes true internally funded research, development, capital and other investments, to rapidly develop, produce and field solutions that address our customers’ mission critical needs and requirements. At Kratos, affordability is a technology, and we seek to utilize proven, leading-edge approaches and technology, not unproven bleeding-edge approaches, with Kratos’ approach designed to reduce cost, schedule and risk, enabling us to be first to market with cost effective solutions. We believe that Kratos is known as an innovative disruptive change agent in the industry, a company that is an expert in designing products and systems up front for successful rapid, large quantity, low-cost future manufacturing which is a value-add competitive differentiator for our large traditional prime system integrator partners and also to our government and commercial customers. Kratos’ primary business areas include virtualized ground systems for satellites and space vehicles; jet-powered unmanned aerial drone systems; advanced vehicles and rocket systems; propulsion systems for drones, missiles, loitering munitions, supersonic systems, spacecraft, and launch systems; C5ISR and microwave electronic products for missile, radar, missile defense, space, satellite, counter-UAS, directed energy, communication, and other systems; and virtual and augmented reality training systems for the warfighter. For more information, visit www.KratosDefense.com and follow Kratos on LinkedIn and X.
Notice Regarding Forward-Looking Statements Certain statements in this press release may constitute “forward-looking statements” within the meaning of the Private Securities Litigation Reform Act of 1995. These forward-looking statements are made on the basis of the current beliefs, expectations and assumptions of the management of Kratos and are subject to significant risks and uncertainty. Investors are cautioned not to place undue reliance on any such forward-looking statements. All such forward-looking statements speak only as of the date they are made, and Kratos undertakes no obligation to update or revise these statements, whether as a result of new information, future events or otherwise. Although Kratos believes that the expectations reflected in these forward-looking statements are reasonable, these statements involve many risks and uncertainties that may cause actual results to differ materially from what may be expressed or implied in these forward-looking statements. For a further discussion of risks and uncertainties that could cause actual results to differ from those expressed in these forward-looking statements, as well as risks relating to the business of Kratos in general, see the risk disclosures in the Annual Report on Form 10-K of Kratos for the year ended December 29, 2025, and in subsequent reports on Forms 10-Q and 8-K and other filings made with the SEC by Kratos.
HOUSTON, Aug. 31, 2026 /PRNewswire/ — Summit Midstream Corporation (NYSE: SMC) (“Summit”, “SMC” or the “Company”) announced today that Double E Pipeline, LLC (“Double E”) has concluded a successful open season and reached a final investment decision on its previously announced mainline compression expansion project, supported by a new long-term firm transportation agreement with an investment-grade shipper.
Highlights
Reached a final investment decision on the mainline compression expansion, with an expected in-service date in the fourth quarter of 2028
Executed a new long-term take-or-pay firm transportation agreement with an investment-grade shipper for 200 MMcf/d, bringing total contracted firm capacity on Double E to approximately 2.2 Bcf/d
Converted the $50 million uncommitted accordion at Summit Permian Transmission to committed, bringing total committed financing capacity to $100 million and fully funding Summit’s expected Double E capital contributions
Robust future growth opportunities associated with data center developments in Texas and New Mexico and connectivity with additional egress pipelines
Management Commentary
Heath Deneke, President, Chief Executive Officer and Chairman, commented, “Today’s announcement is a significant milestone for Summit and Double E and further demonstrates the importance of the pipeline to producers and processors in the Delaware Basin. Double E provides reliable gas transmission service with access to multiple downstream markets, and we continue to expand that connectivity as the basin grows. The strong shipper interest we have seen through the open season reinforces the value of that position and our confidence in the long-term growth opportunity for Double E.
“The open season resulted in 550 MMcf/d of new long-term take-or-pay commitments which underpinned the final investment decision to move forward with the compression expansion and we continue to advance discussions with multiple shippers to subscribe the remaining 450 MMcf/d of incremental forward haul capacity. With these newly signed contracts, we expect to invest approximately $100 million, net to Summit’s 70% interest, to install the mainline compression station, incremental plant connections and related infrastructure, all of which will be funded entirely with the previously announced term loan at Summit Permian Transmission and the now-committed $50 million accordion. We continue to see tremendous production growth surrounding our Delaware Basin operating footprint and fully expect to enter into long-term contracts for the remaining expansion capacity in the coming months. When the project is fully subscribed, we expect our Permian Segment Adjusted EBITDA to grow from approximately $37 million in 2026 to over $100 million by 2030.”
“As we look into the future for the Double E Pipeline beyond filling the mainline compression expansion capacity to Waha, we are very excited about a new phase of demand-pull growth opportunities that are emerging from data center development in Texas and New Mexico as well as additional egress pipelines that are hungry for enhanced access to Permian gas supply. With our connectivity to numerous gas processing facilities in the basin and the Waha Hub, we are incredibly well positioned to attract those markets to the Double E Pipeline and leverage the bi-directional capability of the system to nearly double the outlook for the business in the years ahead.”
Double E Mainline Compression Expansion
The expansion project consists of the installation of a bi-directional mainline compressor station on the Double E system, which will increase the pipeline’s forward haul capacity to Waha by approximately 900 MMcf/d. The compression project along with new plant connections and related infrastructure is expected to cost approximately $100 million net to Summit’s 70% interest and is expected to be placed in service by the fourth quarter of 2028.
The Double E joint venture has already placed a purchase order for the long-lead gas turbine compression units required for the project, securing manufacturing slots necessary to support the targeted in-service date. The project remains subject to FERC and other customary regulatory approvals.
With the new 200 MMcf/d agreement, Double E has secured approximately 550 MMcf/d of binding long-term take-or-pay commitments through the compression expansion open season. Total contracted firm capacity on the pipeline is now approximately 2.2 Bcf/d, held by a diversified group of primarily investment-grade shippers. Double E continues to advance discussions with additional prospective shippers regarding remaining capacity on the expansion.
Summit Permian Transmission Financing
In connection with the final investment decision, Summit Permian Transmission converted the previously uncommitted $50 million accordion under its existing $440 million senior secured term facility maturing in March 2031 into a committed facility. Combined with the $50 million committed delayed draw term facility established at closing in March 2026, Summit expects to have sufficient commitments to fund all of its expected capital contributions to Double E over the next several years. The Summit Permian Transmission term facility remains non-recourse to SMC.
About Double E Pipeline, LLC
Double E is a 135-mile FERC-regulated interstate natural gas transmission pipeline that commenced operations in November 2021 and provides transportation service from receipt points in the Delaware Basin to various delivery points in and around the Waha Hub in Texas.
Double E is owned by subsidiaries of Summit Midstream Corporation (NYSE: SMC) and ExxonMobil (NYSE: XOM) with an ownership interest of 70% and 30%, respectively. Summit Midstream Permian II, LLC is the operator of Double E.
About Summit Midstream Corporation
SMC is a value-driven corporation focused on developing, owning and operating midstream energy infrastructure assets that are strategically located in the core producing areas of unconventional resource basins, primarily shale formations, in the continental United States. SMC provides natural gas, crude oil and produced water gathering, processing and transportation services pursuant to primarily long-term, fee-based agreements with customers and counterparties in five unconventional resource basins: (i) the Williston Basin, which includes the Bakken and Three Forks shale formations in North Dakota; (ii) the Denver-Julesburg Basin, which includes the Niobrara and Codell shale formations in Colorado and Wyoming; (iii) the Fort Worth Basin, which includes the Barnett Shale formation in Texas; (iv) the Arkoma Basin, which includes the Woodford and Caney shale formations in Oklahoma; and (v) the Piceance Basin, which includes the Mesaverde formation as well as the Mancos and Niobrara shale formations in Colorado. SMC has an equity method investment in Double E Pipeline, LLC, which provides interstate natural gas transportation service from multiple receipt points in the Delaware Basin to various delivery points in and around the Waha Hub in Texas. SMC is headquartered in Houston, Texas.
Forward-Looking Statements
This press release includes certain statements concerning expectations for the future that are forward-looking within the meaning of the federal securities laws. Forward-looking statements include, without limitation, any statement that may project, indicate or imply future results, events, performance or achievements and may contain the words “expect,” “intend,” “plan,” “anticipate,” “estimate,” “believe,” “will be,” “will continue,” “will likely result,” and similar expressions, or future conditional verbs such as “may,” “will,” “should,” “would” and “could.” In addition, any statement concerning future financial performance (including future revenues, earnings or growth rates), payment of dividends on any series of stock, ongoing business strategies and possible actions taken by SMC or its subsidiaries are also forward-looking statements. Forward-looking statements also contain known and unknown risks and uncertainties (many of which are difficult to predict and beyond management’s control) that may cause SMC’s actual results in future periods to differ materially from anticipated or projected results. An extensive list of specific material risks and uncertainties affecting SMC is contained in its 2025 Annual Report on Form 10-K filed with the Securities and Exchange Commission (the “SEC”) on March 16, 2026, as amended and updated from time to time. Any forward-looking statements in this press release are made as of the date of this press release and SMC undertakes no obligation to update or revise any forward-looking statements to reflect new information or events.
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