Release – MAIA Biotechnology Delivers Oral and Poster Presentations Showcasing Next-Generation Telomere-Targeting Cancer Therapies at IRT 2026

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September 10, 2026 8:15am EDT Download as PDF

Next-generation divalent agents show increased anticancer activity in preclinical in vitro and in vivo models

CHICAGO, Sept. 10, 2026 (GLOBE NEWSWIRE) — MAIA Biotechnology, Inc. (NYSE American: MAIA) (“MAIA”, the “Company”), a clinical-stage biopharmaceutical company focused on developing immunotherapies for cancer, today announced its presentation of a poster featuring its second-generation telomere-targeting anticancer drug candidates at the recent XXVI International Round Table on Nucleosides, Nucleotides and Nucleic Acids (IRT 2026) held in Barcelona, Spain.

MAIA’s lead drug candidate, ateganosine, is a first-in-class telomere-targeting therapy designed to selectively damage cancer-cell telomeres while activating the body’s antitumor immune response. The poster and oral presentations highlighted both ateganosine’s novel mechanism of action and MAIA’s next-generation divalent telomere-targeting drug candidates, which combine ateganosine with a complementary DNA-targeting agent in a single prodrug molecule. These next-generation candidates are designed to attack tumors through multiple mechanisms, with the goal of delivering greater efficacy than ateganosine alone.

“Our presentations at IRT 2026 reflect the continued scientific progress of our telomere-targeting platform and significant scientific interest in our research,” said Vlad Vitoc, M.D., Founder and CEO of MAIA. “Our next-generation program is designed to expand the therapeutic potential and versatility of our science and support our long-term strategy of developing differentiated therapies that address significant unmet medical needs.”

“It was an honor to participate at IRT 2026, where we shared how we are advancing our telomere-targeting platform with next-generation prodrug molecules designed to enhance antitumor activity,” said Sergei Gryaznov, Ph.D., Chief Scientific Officer of MAIA. “By evaluating multiple molecular designs in complementary cell-based studies and preclinical in vivo tumor models, we have identified structural features associated with the strongest antitumor activity. These findings are helping us optimize our next-generation therapies while further validating the potential of our platform to induce durable antitumor immune responses.”

“IRT 2026 provided an important opportunity to share the progress of our next-generation telomere-targeting programs with leading researchers in the field and to discuss how these advances could translate into new therapeutic approaches for cancer,” said Victor Zaporojan, M.D., Executive Medical Director of MAIA Biotechnology. “The data presented at the conference demonstrate the breadth of our platform beyond ateganosine and reinforce our strategy of developing increasingly potent and optimized molecules that leverage telomere biology to selectively target cancer cells. We believe this work further strengthens the scientific foundation for expanding MAIA’s pipeline across multiple tumor types.”

MAIA’s presentations:

  • Oral: “Novel Divalent Cancer RedOx Activatable Nucleoside Prodrugs as Potent Anticancer Modalities”
  • Poster: “New Telomere-Targeting Dual-Pharmacophore Dinucleotide Prodrugs for Anticancer Therapy”

MAIA was a sponsor of IRT 2026. MAIA’s IRT 2026 poster is available at maiabiotech.com/publications.

About Ateganosine
Ateganosine (THIO, 6-thio-dG or 6-thio-2’-deoxyguanosine) is a first-in-class investigational telomere-targeting agent currently in clinical development to evaluate its activity in non-small cell lung cancer (NSCLC). Telomeres, along with the enzyme telomerase, play a fundamental role in the survival of cancer cells and their resistance to current therapies. The modified nucleotide 6-thio-2’-deoxyguanosine induces telomerase-dependent telomeric DNA modification, DNA damage responses, and selective cancer cell death. Ateganosine-damaged telomeric fragments accumulate in cytosolic micronuclei and activates both innate (cGAS/STING) and adaptive (T-cell) immune responses. The sequential treatment of ateganosine followed by PD-(L)1 inhibitors resulted in profound and persistent tumor regression in advanced, in vivo cancer models by induction of cancer type–specific immune memory. Ateganosine is presently developed as a second or later line of treatment for NSCLC for patients that have progressed beyond the standard-of-care regimen of existing checkpoint inhibitors.

About MAIA Biotechnology, Inc.
MAIA is a targeted therapy, immuno-oncology company focused on the development and commercialization of potential first-in-class drugs with novel mechanisms of action that are intended to meaningfully improve and extend the lives of people with cancer. Our lead program is ateganosine (THIO), a potential first-in-class cancer telomere targeting agent in clinical development for the treatment of NSCLC patients with telomerase-positive cancer cells. For more information, please visit www.maiabiotech.com.

Forward Looking Statements
MAIA cautions that all statements, other than statements of historical facts contained in this press release, are forward-looking statements. Forward-looking statements are subject to known and unknown risks, uncertainties, and other factors that may cause our or our industry’s actual results, levels or activity, performance or achievements to be materially different from those anticipated by such statements. The use of words such as “may,” “might,” “will,” “should,” “could,” “expect,” “plan,” “anticipate,” “believe,” “estimate,” “project,” “intend,” “future,” “potential,” or “continue,” and other similar expressions are intended to identify forward looking statements. However, the absence of these words does not mean that statements are not forward-looking. For example, all statements we make regarding (i) the initiation, timing, cost, progress and results of our preclinical and clinical studies and our research and development programs, (ii) our ability to advance product candidates into, and successfully complete, clinical studies, (iii) the timing or likelihood of regulatory filings and approvals, (iv) our ability to develop, manufacture and commercialize our product candidates and to improve the manufacturing process, (v) the rate and degree of market acceptance of our product candidates, (vi) the size and growth potential of the markets for our product candidates and our ability to serve those markets, and (vii) our expectations regarding our ability to obtain and maintain intellectual property protection for our product candidates, are forward looking. All forward-looking statements are based on current estimates, assumptions and expectations by our management that, although we believe to be reasonable, are inherently uncertain. Any forward-looking statement expressing an expectation or belief as to future events is expressed in good faith and believed to be reasonable at the time such forward-looking statement is made. However, these statements are not guarantees of future events and are subject to risks and uncertainties and other factors beyond our control that may cause actual results to differ materially from those expressed in any forward-looking statement. Any forward-looking statement speaks only as of the date on which it was made. We undertake no obligation to publicly update or revise any forward-looking statement, whether as a result of new information, future events or otherwise, except as required by law. In this release, unless the context requires otherwise, “MAIA,” “Company,” “we,” “our,” and “us” refers to MAIA Biotechnology, Inc. and its subsidiaries.

Investor Relations Contact
+1 (872) 270-3518
[email protected]

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Source: MAIA Biotechnology, Inc.

Released September 10, 2026

Release – 1-800-FLOWERS.COM, Inc. Reports Fiscal 2026 Fourth Quarter and Year-End Results

1-800-FLOWERS.COM, Inc. – link to home page

Research News and Market Data on FLWS

Sep 10, 2026

Reports Fiscal Year 2026 Revenue of $1.50 billion, a Net Loss of $134.8 million, which includes a $45.2 million Non-Cash Goodwill and Intangible Impairment Charge, and Adjusted EBITDA1 of $2.9 million

Company Amends Credit Agreement to Enhance Financial Flexibility and Evaluates a Range of Capital Raising Options to Optimize Capital Structure and Support Strategic Initiatives

Provides Outlook for Fiscal Year 2027

JERICHO, N.Y.–(BUSINESS WIRE)– 1-800-FLOWERS.COM, Inc. (NASDAQ: FLWS), a leading provider of thoughtful expressions designed to help inspire customers to give more, connect more, and build more and better relationships, today reported results for its Fiscal 2026 fourth quarter and year ended June 28, 2026.

“Fiscal 2026 was a year of meaningful progress as we strengthened the foundation of our business and positioned the Company for its next phase of transformation,” said Adolfo Villagomez, Chief Executive Officer of 1-800-Flowers.com. “We strengthened our leadership team, began to modernize our digital and marketing capabilities, simplified how we operate, and became a more customer-first, data-driven organization. As we enter fiscal 2027, accelerating the recovery of our revenue trends is our highest priority. We will continue building these capabilities while increasingly putting them to work to improve customer acquisition, engagement, and retention and to drive better business performance over time.”

“As part of our continued efforts to enhance our financial flexibility and support the ongoing transformation of the business, we recently amended our credit agreement to provide additional financial flexibility,” continued Mr. Villagomez. “We are also evaluating a range of options, including the sale of non-strategic assets and capital raising options, intended to optimize our capital structure and support investments in our transformation and drive future growth. While this work is underway, we remain focused on executing our fiscal 2027 priorities and improving the fundamental drivers of our business.”

Credit Agreement Amendment

The Company announced that it has amended its credit agreement to extend its existing covenant relief and provide the Company with additional flexibility to use a portion of the proceeds from potential asset sales to invest in strategic initiatives and support the ongoing transformation of the business. Additional information regarding the amendment can be found in the Company’s Form 8-K filed with the SEC on September 10, 2026.

Evaluation of Capital Raising Options

The Company is also evaluating a range of options intended to optimize its capital structure and provide additional capital to support investments in its transformation and drive future growth. The potential options may include, but are not limited to, one or more public or private debt or equity financings, potential divestitures of non-strategic assets, or other capital structure transactions. The Company has retained Guggenheim Securities, LLC as its financial advisor in connection with this evaluation. There can be no assurance that the evaluation will result in any transaction or outcome or, if one or more transactions ensue, what the terms of any such transaction might be. The Company is in the early stages of the evaluation and will not comment further during the process.

Fiscal 2026 Fourth Quarter Performance

  • Total consolidated revenues decreased 12.9% to $293.1 million, compared with the prior year period, primarily reflecting a strategic shift to improve marketing effectiveness and profitability. Consumer Floral & Gifts revenues declined 13.4%, Gourmet Foods & Gift Baskets revenues, which were impacted by the timing of Easter, declined 15.4%, while BloomNet revenues increased 1.9%.
  • Gross profit margin decreased 80 basis points to 34.7%, compared with 35.5% in the prior year period, primarily due to deleveraging on the sales decline, higher commodity costs and inventory reserves, partially offset by the Company’s cost reduction and operational efficiency initiatives, along with an approximately $7 million benefit related to tariff refunds.
  • Operating expenses decreased $16.7 million year-to-year to $158.2 million. Excluding non-recurring charges and the impact of the Company’s non-qualified deferred compensation plan in both periods, operating expenses decreased $8.9 million as compared with the prior year to $150.8 million, primarily due to lower marketing and labor costs.
  • Net loss for the quarter was $52.3 million, or $(0.82) per diluted share, as compared to a net loss of $(51.9) million, or $(0.82) per share, in the prior year period.
  • Adjusted net loss1 was $(51.6) million, or $(0.80) per diluted share, compared with an Adjusted net loss1 of $(43.8) million, or $(0.69) per share, in the prior year period.
  • Adjusted EBITDA1 loss for the quarter was $(31.0) million, compared with Adjusted EBITDA1 loss of $(24.2) million in the prior year period.
(1) Refer to “Definitions of Non-GAAP Financial Measures” and the tables attached at the end of this press release for reconciliation of non-GAAP results to applicable GAAP results.

Fiscal Year 2026 Performance

  • Total consolidated revenues decreased 10.8% to $1.50 billion, compared with total consolidated revenues of $1.69 billion in the prior year period.
  • Gross profit margin decreased 70 basis points to 38.0%, compared with 38.7% in the prior year period, primarily due to deleveraging on the sales decline, higher commodity costs and inventory reserves, partially offset by the Company’s cost reduction and operational efficiency initiatives. Excluding the impact of non-recurring charges in the year ago period, gross profit margin decreased 110 basis points as compared with the prior year period.
  • Operating expenses decreased $158.6 million to $698.5 million, as compared with the prior year period. Excluding non-recurring charges and the impact of the Company’s non-qualified deferred compensation plan in both periods, operating expenses decreased by $62.0 million to $633.3 million, as compared with the prior year.
  • Net loss for the fiscal year was $(134.8) million or $(2.11), per diluted share, which includes a $45.2 million non-cash goodwill and intangible impairment charge, compared with a net loss of $(200.0) million, or $(3.13) per diluted share, in the prior year period, which included a non-cash goodwill and intangible impairment charge of $143.8 million.
  • Adjusted net loss1 was $(77.5) million, or $(1.21) per diluted share, compared with Adjusted net loss1 of $(52.5) million, or $(0.82) per diluted share, in the prior year period.
  • Adjusted EBITDA1 for the fiscal year was $2.9 million, as compared with $29.2 million in the prior year period.

Segment Results

The Company provides Fiscal 2026 fourth quarter and full year selected financial results for its Gourmet Foods & Gift Baskets, Consumer Floral & Gifts, and BloomNet® segments in the tables attached to this release and as follows:

Gourmet Foods & Gift Baskets: For the quarter, revenues decreased 15.4% to $85.8 million, as compared with the prior year period. Gross profit margin decreased 830 basis points from the prior year period to 17.7% due to deleveraging on the sales decline and increased tariff, commodity and shipping costs. The segment contribution margin1 loss was $23.4 million, compared with segment contribution margin loss of $19.0 million in the prior year period, excluding severance costs.

For the full fiscal year, revenue decreased 5.2% to $768.5 million. Gross profit margin decreased 130 basis points to 35.5%. Excluding non-recurring costs in both years, segment contribution margin1 for the year was $52.7 million, compared with $58.8 million in the prior year.

Consumer Floral & Gifts: For the quarter, revenues decreased 13.4% to $182.8 million, as compared with the prior year period. Gross profit margin increased 220 basis points from the prior year period to 40.7% on lower commodity and shipping costs. The segment contribution margin1 was $17.1 million, compared with $17.4 million in the prior year period, excluding severance and impairment costs.

For the full fiscal year, revenues decreased 17.7% to $638.9 million, as compared with the prior year period. Gross profit margin increased 10 basis points from the prior year period to 39.4%. Excluding the non-recurring costs in both years, segment contribution margin was $48.6 million, compared with $50.5 million in the prior year.

BloomNet: For the quarter, revenues increased 1.9% to $24.7 million, as compared with the prior year period. Gross profit margin increased 190 basis points from the prior year period to 48.8%. The segment contribution margin1 was $7.4 million, compared with $6.5 million in the prior year period, excluding severance costs.

For the full fiscal year, revenues decreased 1.9% to $96.8 million, as compared with the prior year period. Gross profit margin decreased 10 basis points from the prior year period to 48.4%. Excluding the impact of the severance charges, segment contribution margin1 for the year was $27.2 million, compared with $29.3 million in the prior year.

Fiscal Year 2027 Outlook

During Fiscal 2027, the Company expects to continue reinvesting a significant portion of the cost savings achieved through its operational efficiency initiatives into strategic growth investments. These investments include further modernization of the Company’s marketing capabilities, continued development of its marketing technology platform, enhancements to its digital customer experience and personalization capabilities, and other initiatives designed to strengthen customer acquisition, engagement, and retention.

While the Company expects the benefits of these investments to build over multiple years, management believes Fiscal 2027 marks the next phase of its transformation. The Company will continue to build key capabilities while increasingly leveraging the investments made during Fiscal 2026 to improve operating performance and create sustainable long-term value.

For Fiscal 2027, the Company expects net revenues to decline in the mid-single digit range compared with Fiscal 2026. The Company expects Fiscal 2027 adjusted EBITDA of $10 million to $15 million, which includes approximately $12 million of additional compensation expense versus Fiscal 2026.

Conference Call

The Company will conduct a conference call to discuss its financial results today, September 10, 2026, at 8:00 a.m. (ET). The conference call will be webcast from the Investors section of the Company’s website at www.1800flowersinc.com. A recording of the call will be posted on the Investors section of the Company’s website within two hours of the call’s completion.

Definitions of Non-GAAP Financial Measures:

We sometimes use financial measures derived from consolidated financial information, but not presented in our financial statements prepared in accordance with U.S. generally accepted accounting principles (“GAAP”). Certain of these are considered “Non-GAAP financial measures” under the U.S. Securities and Exchange Commission rules. Non-GAAP financial measures referred to in this document are either labeled as “Non-GAAP,” “adjusted” or designated as such with a “1”. See below for definitions and the reasons why we use these non-GAAP financial measures. Where applicable, see the Selected Financial Information below for reconciliations of these non-GAAP measures to their most directly comparable GAAP financial measures. Reconciliations for forward-looking figures would require unreasonable efforts at this time because of the uncertainty and variability of the nature and amount of certain components of various necessary GAAP components, including, for example, those related to compensation, tax items, amortization or others that may arise during the year, and the Company’s management believes such reconciliations would imply a degree of precision that would be confusing or misleading to investors. For the same reasons, the Company is unable to address the probable significance of the unavailable information. The lack of such reconciling information should be considered when assessing the impact of such disclosures.

EBITDA and Adjusted EBITDA:

We define EBITDA as net income (loss) before interest, taxes, depreciation, and amortization. Adjusted EBITDA is defined as EBITDA adjusted for the impact of stock-based compensation, Non-Qualified Deferred Compensation Plan (“NQDC”) investment appreciation/depreciation, goodwill and intangible impairment and for certain items affecting period-to-period comparability. See Selected Financial Information for details on how EBITDA and Adjusted EBITDA were calculated for each period presented. The Company presents EBITDA and Adjusted EBITDA because it considers such information meaningful supplemental measures of its performance and believes such information is frequently used by the investment community in the evaluation of similarly situated companies. The Company uses EBITDA and Adjusted EBITDA as factors to determine the total amount of incentive compensation available to be awarded to executive officers and other employees. The Company’s credit agreement uses EBITDA and Adjusted EBITDA-related items to determine its interest rate and to measure compliance with certain covenants. EBITDA and Adjusted EBITDA are also used by the Company to evaluate and price potential acquisition candidates. EBITDA and Adjusted EBITDA have limitations as analytical tools and should not be considered in isolation or as a substitute for analysis of the Company’s results as reported under GAAP. Some of the limitations are: (a) EBITDA and Adjusted EBITDA do not reflect changes in, or cash requirements for, the Company’s working capital needs; (b) EBITDA and Adjusted EBITDA do not reflect the interest expense, or the cash requirements necessary to service interest or principal payments, on the Company’s debts; and (c) although depreciation and amortization are non-cash charges, the assets being depreciated and amortized may have to be replaced in the future and EBITDA does not reflect any cash requirements for such capital expenditures. EBITDA and Adjusted EBITDA should only be used on a supplemental basis combined with GAAP results when evaluating the Company’s performance.

Segment Contribution Margin and Adjusted Segment Contribution Margin:

We define Segment Contribution Margin as earnings before interest, taxes, depreciation, and amortization, before the allocation of corporate overhead expenses. Adjusted Segment Contribution Margin is defined as Segment Contribution Margin adjusted for certain items affecting period-to-period comparability. See Selected Financial Information for details on how Segment Contribution Margin and Adjusted Segment Contribution Margin were calculated for each period presented. When viewed together with our GAAP results, we believe Segment Contribution Margin and Adjusted Segment Contribution Margin provide management and users of the financial statements meaningful information about the performance of our business segments. Segment Contribution Margin and Adjusted Segment Contribution Margin are used in addition to and in conjunction with results presented in accordance with GAAP and should not be relied upon to the exclusion of GAAP financial measures. The material limitation associated with the use of Segment Contribution Margin and Adjusted Segment Contribution Margin is that they are an incomplete measure of profitability as they do not include all operating expenses or non-operating income and expenses. Management compensates for this limitation when using these measures by looking at other GAAP measures, such as Operating Income (Loss) and Net Income (Loss).

Adjusted Net Income (Loss) and Adjusted or Comparable Net Income (Loss) Per Common Share:

We define Adjusted Net Income (Loss) and Adjusted or Comparable Net Income (Loss) Per Common Share as Net Income (Loss) and Net Income (Loss) Per Common Share adjusted for certain items affecting period-to-period comparability. See Selected Financial Information below for details on how Adjusted Net Income (Loss) Per Common Share and Adjusted or Comparable Net Income (Loss) Per Common Share were calculated for each period presented. We believe that Adjusted Net Income (Loss) and Adjusted or Comparable Net Income (Loss) Per Common Share are meaningful measures because they increase the comparability of period-to-period results. Since these are not measures of performance calculated in accordance with GAAP, they should not be considered in isolation of, or as a substitute for, GAAP Net Income (Loss) and Net Income (Loss) Per Common Share, as indicators of operating performance and they may not be comparable to similarly titled measures employed by other companies.

Free Cash Flow:

We define Free Cash Flow as net cash provided by (used in) operating activities less capital expenditures. The Company considers Free Cash Flow to be a liquidity measure that provides useful information to management and investors about the amount of cash generated by the business after the purchases of fixed assets, which can then be used to, among other things, invest in the Company’s business, make strategic acquisitions, strengthen the balance sheet, and repurchase stock or retire debt. Free Cash Flow is a liquidity measure that is frequently used by the investment community in the evaluation of similarly situated companies. Since Free Cash Flow is not a measure of performance calculated in accordance with GAAP, it should not be considered in isolation or as a substitute for analysis of the Company’s results as reported under GAAP. A limitation of the utility of Free Cash Flow as a measure of financial performance is that it does not represent the total increase or decrease in the Company’s cash balance for the period.

About 1-800-FLOWERS.COM, Inc.

1-800-FLOWERS.COM, Inc. is a leading provider of thoughtful expressions designed to help inspire customers to give more, connect more, and build more and better relationships. The Company’s e-commerce business platform features an all-star family of brands, including: 1-800-Flowers.com®, 1-800-Baskets.com®, Card Isle®, Cheryl’s Cookies®, Harry & David®, PersonalizationMall.com®, Shari’s Berries®, FruitBouquets.com®, Things Remembered®, Moose Munch®, The Popcorn Factory®, Wolferman’s Bakery®, Vital Choice®, Simply Chocolate® and Scharffen Berger®. Through the Celebrations Passport® loyalty program, which provides members with free standard shipping and no service charge on eligible products across our portfolio of brands, 1-800-FLOWERS.COM, Inc. strives to deepen relationships with customers. The Company also operates BloomNet®, an international floral and gift industry service provider offering a broad-range of products and services designed to help its members grow their businesses profitably; Napco℠, a resource for floral gifts and seasonal décor; and DesignPac®, a manufacturer of gift baskets and towers. 1-800-FLOWERS.COM, Inc. was recognized among America’s Most Trustworthy Companies by Newsweek for 2024. 1-800-FLOWERS.COM, Inc. was also recognized as one of America’s Most Admired Workplaces for 2025 by Newsweek and was named to the Fortune 1000 list in 2022. Shares in 1-800-FLOWERS.COM, Inc. are traded on the NASDAQ Global Select Market, ticker symbol: FLWS. For more information, visit 1800flowersinc.com.

FLWS-COMP

FLWS-FN

Special Note Regarding Forward Looking Statements:

This press release contains forward-looking statements within the meaning of the Private Securities Litigation Reform Act of 1995. These forward-looking statements represent the Company’s current expectations or forecasts concerning future events; they do not relate strictly to historical or current facts. Such statements can generally be identified by words such as “anticipate,” “estimate,” “expect,” “project,” “intend,” “plan,” “believe,” “foresee,” “forecast,” “likely,” “should,” “will,” “target,” or similar words or phrases. These forward-looking statements are subject to risks, uncertainties, and other factors, many of which are outside of the Company’s control, which could cause actual results to differ materially from the results expressed or implied in the forward-looking statements, including, but not limited to, statements relating to future actions; the Company’s ability to leverage its operating platform and reduce its operating expense ratio; its ability to successfully integrate acquired businesses and assets; its ability to successfully execute its strategic priorities; its ability to cost effectively acquire and retain customers and drive purchase frequency; the outcome of contingencies, including legal proceedings in the normal course of business; its ability to compete against existing and new competitors; its ability to manage expenses associated with sales and marketing and necessary general and administrative and technology investments; its ability to reduce promotional activities and achieve more efficient marketing programs; and general consumer sentiment and industry and economic conditions that may affect levels of discretionary customer purchases of the Company’s products. The Company cannot guarantee that any forward-looking statement will be realized. Achievement of future results is subject to risk, uncertainties and potentially inaccurate assumptions. Should known or unknown risks or uncertainties materialize, or should underlying assumptions prove inaccurate, actual results could differ materially from past results and those anticipated, estimated or projected. You should bear this in mind as you consider forward-looking statements. The Company undertakes no obligation to publicly update any of the forward-looking statements, whether because of new information, future events or otherwise, made in this release or in any of its SEC filings. Consequently, you should not consider any such list to be a complete set of all potential risks and uncertainties. For a more detailed description of these and other risk factors, refer to the Company’s SEC filings, including the Company’s Annual Reports on Form 10-K and its Quarterly Reports on Form 10-Q.

View full release here.

View source version on businesswire.com: https://www.businesswire.com/news/home/20260910833518/en/

Investor Contact:

Andy Milevoj

[email protected]

Media Contact:

[email protected]

Source: 1-800-FLOWERS.COM, Inc.

Century Lithium Corp. (CYDVF) – Angel Island Permitting Advances


Thursday, September 10, 2026

Mark Reichman, Managing Director, Equity Research Analyst, Natural Resources, Noble Capital Markets, Inc.

Refer to the full report for the price target, fundamental analysis, and rating.

A major milestone. Century Lithium reached a major permitting milestone at its 100%-owned Angel Island Lithium Project in Nevada with the submission of its Mine Plan of Operations and Nevada Reclamation Permit Application. The Plan of Operations formally defines the proposed project for federal environmental review and moves Angel Island into the National Environmental Policy Act (NEPA) process.

Angel Island lithium project. Angel Island will be a large, long-life surface mine designed to produce battery-grade lithium carbonate on site. Development would be phased from approximately 8,300 tons per day during the first four years to as much as 16,500 tons per day from years five through 40, supported by direct lithium extraction, closed-loop water recycling, and significant power and water infrastructure.


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Equity Research is available at no cost to Registered users of Channelchek. Not a Member? Click ‘Join’ to join the Channelchek Community. There is no cost to register, and we never collect credit card information.

This Company Sponsored Research is provided by Noble Capital Markets, Inc., a FINRA and S.E.C. registered broker-dealer (B/D).

*Analyst certification and important disclosures included in the full report. NOTE: investment decisions should not be based upon the content of this research summary. Proper due diligence is required before making any investment decision. 

Ocugen (OCGN) – Interim Analysis Report Recommends Continuing Stargardt Phase 2/3 Trial, But Causes Confusion


Thursday, September 10, 2026

Robert LeBoyer, Senior Vice President, Equity Research Analyst, Biotechnology, Noble Capital Markets, Inc.

Refer to the full report for the price target, fundamental analysis, and rating.

The DMC Recommends Continuing The GARDian Trial. Data Monitoring Committee (DMC) has completed its planned interim analysis of the Phase 2/3 GARDian trial of OCU410ST in Stargardt disease. The analysis included 26 patients out of the planned enrollment of about 50, evaluating 16 treated patients and 10 controls. The DMC recommended continuing the trial as planned, with an evaluation of the entire patient population at 8 months after treatment. We believe the disclosure has led to misinterpretation of the recommendation.

The Evaluation Included Just Half The Enrollment In An Orphan-Sized Trial. Stargardt is an Orphan disease with a Phase 2/3 trial based on a small enrollment of about 50 patients. While this helps enrollment, each patient’s data has a larger impact than in larger trials.


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Equity Research is available at no cost to Registered users of Channelchek. Not a Member? Click ‘Join’ to join the Channelchek Community. There is no cost to register, and we never collect credit card information.

This Company Sponsored Research is provided by Noble Capital Markets, Inc., a FINRA and S.E.C. registered broker-dealer (B/D).

*Analyst certification and important disclosures included in the full report. NOTE: investment decisions should not be based upon the content of this research summary. Proper due diligence is required before making any investment decision. 

Resolution Minerals Ltd (RML) – Nasdaq Listing Expands U.S. Investor Access


Thursday, September 10, 2026

Mark Reichman, Managing Director, Equity Research Analyst, Natural Resources, Noble Capital Markets, Inc.

Refer to the full report for the price target, fundamental analysis, and rating.

Nasdaq listing enhances Resolution’s U.S. market presence. Resolution Minerals’ American Depositary Shares, or ADSs, commenced trading on the Nasdaq Capital Market on September 9, 2026, under the ticker RML. Each ADS represents 200 ordinary Resolution shares, while the ASX remains the company’s primary listing. Resolution did not conduct a U.S. capital raise in connection with the Nasdaq listing.

The listing supports Resolution’s broader U.S. strategy. We expect the Nasdaq listing to increase the company’s visibility among U.S. retail and institutional investors and strengthen its ability to raise capital in the United States. The timing is favorable given heightened U.S. interest in securing domestic supplies of critical minerals, particularly tungsten and antimony.


Get the Full Report

Equity Research is available at no cost to Registered users of Channelchek. Not a Member? Click ‘Join’ to join the Channelchek Community. There is no cost to register, and we never collect credit card information.

This Research is provided by Noble Capital Markets, Inc., a FINRA and S.E.C. registered broker-dealer (B/D).

*Analyst certification and important disclosures included in the full report. NOTE: investment decisions should not be based upon the content of this research summary. Proper due diligence is required before making any investment decision. 

Nasdaq Deepens Push Into Tokenized Stocks With $100 Million Payward Investment

Nasdaq (NASDAQ: NDAQ) announced Thursday that it is expanding its relationship with Payward, the parent company of Kraken, as part of a broader effort to bring tokenized equities into mainstream capital markets infrastructure.

The agreement includes a $100 million investment by Nasdaq Ventures in Payward, continued development of the Nasdaq Equity Token (NET) framework, and a new market-surveillance agreement covering Payward’s trading venues. Nasdaq said it expects NETs to launch in the second quarter of 2027, subject to the necessary regulatory and operational work.

For Nasdaq, the appeal is not simply adding blockchain technology to stock trading. The company is positioning tokenization as a way to make capital markets more continuous, efficient and globally connected while preserving the investor protections, issuer rights and market-integrity standards that underpin traditional exchanges.

What Is a Tokenized Stock?

At its simplest, a tokenized equity is a digital representation of ownership in a company recorded on a blockchain or distributed ledger. The underlying economic exposure can resemble that of a traditional share, but the ownership record and transfer mechanics are handled through blockchain-based infrastructure rather than solely through conventional securities systems.

That distinction matters because tokenization can potentially change how securities are transferred, settled and used as collateral. Proponents argue that blockchain-based securities could support faster settlement, fractional ownership, broader access and more automated handling of functions such as dividends or voting. At the same time, tokenized equities remain securities and still have to operate within applicable regulatory frameworks.

Nasdaq’s approach is particularly notable because it is trying to avoid creating a separate parallel market that sits outside traditional exchange protections. Under its framework, a security could exist in either conventional or tokenized form while preserving the same economic rights and, in Nasdaq’s model, the same issuer protections.

Why Nasdaq Thinks Tokenization Could Improve Markets

One of the biggest potential benefits is settlement efficiency. Today, U.S. equity trades generally settle one business day after execution. Before that settlement occurs, clearing institutions must manage counterparty exposure and require collateral against outstanding obligations. Payward co-CEO Arjun Sethi noted in Thursday’s announcement that more than $2 trillion of stock trades move through the U.S. clearing system each day, with trades netted down by roughly 98% before final settlement.

Moving securities onto blockchain-based rails could reduce the amount of time assets and cash remain in transit between counterparties. In theory, faster or even near-instant settlement could lower collateral requirements, improve capital efficiency and allow investors and institutions to redeploy assets more quickly.

That fits into Nasdaq’s broader vision of always-on market infrastructure — systems capable of moving capital, collateral and securities more continuously across markets instead of being tied entirely to traditional trading and settlement windows. Nasdaq is already moving in that direction elsewhere, including plans to extend trading on the Nasdaq Stock Market toward a 24-hour structure.

Kraken Brings the Crypto Infrastructure

Payward gives Nasdaq an established digital-asset partner. Kraken is one of the largest global cryptocurrency trading platforms, while Payward also operates the infrastructure behind xStocks, a tokenized-equities ecosystem designed to provide blockchain-based exposure to publicly traded stocks.

Earlier this year, Nasdaq and Payward began working together on an equities transformation gateway intended to connect regulated securities infrastructure with digital networks. The goal is to allow tokenized equities to move between traditional, permissioned market systems and blockchain-based environments without stripping away the rights associated with the underlying shares.

Thursday’s $100 million investment deepens that relationship and signals that Nasdaq views the project as more than an experimental blockchain initiative. The companies will now work on the global distribution, trading and post-trade infrastructure needed to support broader adoption of NETs. Payward will also deploy Nasdaq’s surveillance technology across its crypto, equities, tokenized-equities, futures and options venues.

That surveillance agreement is important because one of the central questions surrounding digital-asset markets has been whether blockchain-based trading can offer the same level of transparency and oversight investors expect from regulated securities exchanges. Nasdaq is effectively betting that tokenization will gain broader acceptance if the technology is paired with familiar market controls rather than positioned as a replacement for them.

Tokenization Is Already Moving Into Traditional Finance

The Nasdaq initiative is part of a much larger shift underway across financial markets. Blockchain-based assets were once largely associated with cryptocurrencies, but major financial institutions have increasingly begun experimenting with tokenized versions of traditional assets such as U.S. Treasuries, money-market funds, private credit and securities.

BlackRock’s tokenized U.S. dollar institutional liquidity fund, BUIDL, has been one of the most visible examples. The fund uses blockchain infrastructure to represent ownership interests and facilitate eligible on-chain transfers while continuing to invest primarily in traditional short-term assets such as Treasury bills and repurchase agreements.

The next step is equities. If tokenized stocks can preserve traditional shareholder rights while operating on digital rails, they could potentially allow investors to transfer securities more easily between platforms, use stocks more efficiently as collateral and eventually trade or settle assets across a broader range of hours and jurisdictions.

The Infrastructure May Matter More Than the Token

For investors, it can be tempting to focus on the novelty of owning a stock as a blockchain token. But the more significant change may be happening behind the scenes. Modern equity markets already operate electronically. The potential advantage of tokenization is therefore less about converting a paper certificate into a digital object and more about redesigning the infrastructure used for ownership, settlement, collateral and asset transfers.

Nasdaq’s involvement gives that effort additional credibility because the company already operates some of the core infrastructure underlying global securities markets. Its strategy is not to abandon the existing system, but to create a bridge between conventional capital markets and blockchain-based networks.

If that model works, tokenized equities could gradually become another format in which investors hold and transfer securities rather than an entirely separate asset class.

A 2027 Test for Mainstream Adoption

The planned second-quarter 2027 launch of Nasdaq Equity Tokens will be an important test of whether tokenized equities can move beyond crypto-native platforms and become part of mainstream market infrastructure.

There are still significant challenges. Regulatory requirements remain complex, cybersecurity risks are real, and the industry has not yet settled on common standards for how tokenized securities should move across exchanges, wallets and blockchain networks.

But Nasdaq’s decision to commit $100 million to Payward suggests that one of the world’s largest exchange operators believes the technology has moved beyond the proof-of-concept stage.

The broader question is no longer simply whether stocks can be tokenized. Technically, that has already been demonstrated. The more important question is whether tokenized shares can deliver faster settlement, improved capital efficiency and broader market access without sacrificing the regulatory protections and market integrity investors already expect.

Nasdaq and Payward are now betting that they can.

Swarmer to Acquire Ratel Robotics for Up to $224 Million, Expanding Into Unmanned Ground Systems

Swarmer, Inc. (NASDAQ: SWMR) announced Thursday that it has entered into a definitive agreement to acquire Ratel Robotics, a leading Ukrainian manufacturer of unmanned ground vehicles, in a transaction valued at up to $224 million if all earnout milestones are achieved.

The acquisition would mark Swarmer’s first major deal under Chairman Erik Prince and significantly expand the company beyond autonomous drone software by adding a portfolio of combat-proven ground vehicles already being used in Ukraine for logistics, casualty evacuation, reconnaissance, demining and drone-launch missions.

The consideration will consist of a mix of cash and stock, with closing subject to customary legal, regulatory and shareholder approvals. More than 300 Ratel employees are expected to join Swarmer following the transaction, bringing the combined company to nearly 500 employees. Ratel founder and CEO Taras Ostapchuk is expected to remain in his role and report to Swarmer President and U.S. CEO Alex Fink.

From Drone Software to a Broader Autonomous Platform

Swarmer has built its business around vendor-agnostic autonomy software designed to allow a single operator to control large numbers of unmanned systems in real time. Its technology focuses on swarm coordination, distributed decision-making and integration across multiple unmanned platforms rather than manufacturing individual drones itself.

The company says its systems have supported more than 100,000 real-world combat missions in Ukraine since first being deployed there in April 2024. That operating history has given Swarmer access to large amounts of battlefield telemetry, sensor data and operational feedback that can be used to improve autonomous performance and resilience.

Ratel adds the hardware side of that equation. Its unmanned ground vehicles are designed for missions that place soldiers at particularly high risk, including supply delivery, casualty evacuation, engineering operations, mine clearance and strike support. The company is also expanding into unmanned aerial systems, mobile workshops and solar-powered trailers.

For Swarmer, the strategic logic is to combine its autonomy software with a broader base of battlefield-tested platforms rather than remaining solely at the software layer.

Ratel Brings Scale and Existing Defense Contracts

Ratel is not an early-stage prototype developer. The company has already secured approximately $86 million in contracts this year and is in discussions with multiple NATO countries through the “Build With Ukraine” initiative.

According to Swarmer, Ratel products represented approximately 37% of the 11 billion Ukrainian hryvnia, or roughly $247 million, spent by Ukraine’s Ministry of Defense Procurement Agency on unmanned ground vehicle contracts between January 1 and April 18, 2026.

That installed base is particularly important in a defense market increasingly emphasizing systems that have already been tested in active combat environments. Ratel’s serial Ratel H and Ratel M vehicles carry NATO stock numbers and AQAP 2110 certification, giving the company a foundation for expansion beyond Ukraine.

Ground Robots Are Becoming a Bigger Part of Modern Warfare

The acquisition also reflects a broader shift in defense technology. Ukraine has become one of the world’s most active proving grounds for unmanned systems, with aerial drones receiving much of the attention early in the war. Ground robotics, however, are increasingly being used for missions where sending personnel creates unnecessary risk, including logistics, reconnaissance, casualty evacuation and perimeter support.

That trend fits directly with Swarmer’s view of Ratel’s vehicles as more than standalone ground robots. Management believes UGVs can serve as mobile launch platforms for drones, interceptors and other autonomous assets, creating integrated systems that operate across both ground and air domains.

Consolidation Comes to Ukraine’s Defense-Tech Industry

The transaction may also be significant as an early example of consolidation within Ukraine’s highly fragmented defense-technology sector. The country has developed hundreds of drone and robotics companies during the war, many of which have built products quickly around immediate battlefield requirements. That decentralized ecosystem helped accelerate innovation, but it has also produced a large number of relatively small manufacturers that can face difficulty scaling production, accessing Western capital and selling into larger NATO procurement programs.

Swarmer itself appears to be positioning the transaction as the beginning of a broader platform strategy. Prince has said the company intends to assemble battlefield-tested systems into a more integrated defense-technology offering, suggesting additional acquisitions could eventually follow.

Building an Integrated Autonomous Defense Company

For investors, the acquisition changes the profile of Swarmer in an important way. Until now, the company’s core value proposition has centered on the software layer — providing autonomy, coordination and decision-making capabilities that can work across different unmanned platforms. Ratel would add manufacturing, physical systems, existing government contracts and a sizable workforce operating directly inside Ukraine’s defense ecosystem.

That combination could allow Swarmer to pursue larger integrated programs while continuing to deploy its autonomy technology across third-party systems. Ratel extends that strategy onto the ground.

If the transaction closes and the two companies successfully integrate their technologies, Swarmer would emerge with a much broader portfolio spanning autonomous software, aerial systems and unmanned ground vehicles — all built around technologies that have already been exposed to real-world combat conditions.

For a defense industry increasingly focused on autonomy, interoperability and reducing the number of personnel placed in high-risk environments, that could make the Ratel acquisition more than simply an expansion of Swarmer’s product catalog. It could be an early step toward building a larger, multi-domain autonomous defense platform.

Investors following the broader defense technology sector can also explore Noble Capital Markets coverage of T3 Defense (NASDAQ: DFNS), a defense-focused holding company pursuing growth through acquisitions, and Kratos Defense & Security Solutions (NASDAQ: KTOS), whose portfolio includes unmanned systems and other national security technologies.

Release – T3 Defense Targets Accelerating European Demand for Air Defense Ground-System Components

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Recent European air-defense procurement, localization and operational initiatives, including a reported Iron Dome ground-system manufacturing program in Germany, underscore growing requirements for launcher, mobility, power-generation, command-and-control and related mission-critical hardware categories served by T3 Defense subsidiaries.

September 08, 2026 09:20 ET  | Source: T3 Defense Inc.

NEW YORK and NETANYA, Israel, Sept. 08, 2026 (GLOBE NEWSWIRE) — T3 Defense Inc. (Nasdaq: DFNS) (“T3 Defense” or the “Company”), a defense company that acquires and operates mission-critical defense businesses involved in national security programs, today highlighted growing European demand for ground-segment subsystems used in layered air- and missile-defense architectures.

Recent defense developments in Europe underscore increased investment in integrated air- and missile-defense capabilities, including launcher systems, mobile platforms, power-generation equipment, command-and-control infrastructure and related support hardware. T3 Defense operating subsidiaries manufacture products serving these ground-segment categories, which are required to deploy, operate and sustain modern air-defense systems.

Recent developments include:

  • Manufacturing of ground-system components for Rafael’s Israeli-developed Iron Dome short-range air-defense system is expected to begin at Volkswagen’s former Osnabrück production site in Germany following the planned end of vehicle production in 2027. The initiative involves Rafael, the State of Lower Saxony and Munich-based investment firm Aurelius Capital, and is expected to include military vehicles, German power-generation units, launchers and related hardware, to support expanding German and European air-defense requirements.
  • A multi-layered air and missile defense agreement between Israel and Greece, at approximately $3.5 billion (≈€3 billion). The agreement covers short-, medium- and long-range interceptor layers, multi-mission radars, an integrated national command-and-control (C2) layer and a supplementary counter-drone package, with a reported local-industry participation component of roughly one quarter of program value. Greece is reportedly planning approximately €28 billion in defense modernization spending through 2036.
  • A live-fire trial in early September 2026 by the German Navy of an Israeli-developed ballistic missile system, launched from an operational German vessel configured with a command trailer and a launcher.

“Europe is investing in the infrastructure required to deploy, operate and sustain layered air- and missile-defense systems and interceptors,” said Menny Shalom, Chairman and Chief Executive Officer of T3 Defense. “These architectures depend on a range of ground-segment hardware, including launcher structures, command and control shelters, power-generation equipment, mobile platforms, masts, positioning systems and training and simulation equipment. These are the qualification-driven product categories in which our subsidiaries operate. We have deliberately assembled a portfolio in the qualification-driven sub-system categories that every layered air defense and counter-drone program consumes, and we are well positioned to pursue related opportunities and convert those into customer programs and orders.”

About T3 Defense Inc.

T3 Defense Inc. (Nasdaq: DFNS) is a defense company that acquires and operates mission-critical defense businesses involved in national security programs. It focuses on manufacturers with strong customer relationships and solid order backlogs, often capacity- and resource-constrained, in specialized areas such as drones and autonomous vehicles, counter-drone systems, advanced manufacturing, tactical robotics, and AI software and system integration. Through disciplined acquisitions, centralized capital and strategy, and decentralized day-to-day operations, T3 Defense aims to strengthen essential defense capabilities and build long-term value. For more information, visit www.t3dfns.com.

Forward-Looking Statements

This press release contains forward-looking statements within the meaning of Section 27A of the Securities Act of 1933, as amended, and Section 21E of the Securities Exchange Act of 1934, as amended. All statements other than statements of historical fact are forward-looking statements, including, without limitation, statements regarding European air and missile defense demand and procurement trends; the anticipated scope, timing, structure or localization of any European program or production activity; the categories of sub-systems such programs may consume; the potential for the Company or its subsidiaries to receive orders, qualify into supply chains, or generate revenue in Europe or elsewhere; the anticipated capabilities and availability of the platforms, products and services described herein; the potential expansion of previously disclosed orders, including the potential expansion of the Tiltan hardware-in-the-loop program; and the Company’s growth and acquisition strategy. These statements are based on management’s current expectations and assumptions and involve known and unknown risks and uncertainties that could cause actual results to differ materially from those expressed or implied, including: the absence of any order, contract or contractual relationship in connection with the European programs referenced herein; the risk that publicly reported third-party developments are inaccurate, incomplete, delayed, restructured or abandoned; reliance on information reported by third parties that the Company has not independently verified; local-content, offset, export-control, licensing and qualification requirements that may exclude the Company’s subsidiaries from European supply chains; customer qualification and testing cycles; defense program funding and procurement timing; dependence on government contracts and defense original equipment manufacturer relationships; manufacturing execution, capacity and supply-chain risks; customer concentration; the risk that backlog and pipeline do not convert into revenue; competitive and geopolitical conditions, including conditions in Israel and in Europe; the Company’s liquidity and capital resources; the Company’s ability to maintain compliance with Nasdaq listing requirements; the integration of acquired businesses; and other risks described in the Company’s filings with the Securities and Exchange Commission, including its Annual Report on Form 10-K, Quarterly Reports on Form 10-Q, and Current Reports on Form 8-K. Forward-looking statements speak only as of the date of this release, and the Company undertakes no obligation to update or revise them, except as required by law.

Contact Us:

T3 Defense Inc.
575 5th Avenue
New York, NY 10017
[email protected]
www.t3dfns.com

Investor Relations
The Equity Group Inc.
Lena Cati
[email protected]
+1 212 836-9611

Val Ferraro
[email protected]
+1 212 836-9633

Release – GeoVax Welcomes Launch of Global Mpox Vaccine Stockpile, Highlights GEO-MVA Readiness to Support Diversified Global Supply

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Gavi-funded, ICG-Coordinated Initiative Establishes Long-Term Infrastructure for Timely and Equitable Mpox Vaccine Access During Outbreaks

New Stockpile Framework Supports Sustainable Supply and Long-Term Global Preparedness

ATLANTA, GA – September 9, 2026 – GeoVax Labs, Inc. (Nasdaq: GOVX), a clinical-stage biotechnology company developing vaccines and immunotherapies against infectious diseases and cancers, today welcomed the launch of a new global mpox vaccine stockpile designed to provide countries with timely, equitable and sustainable access to vaccines during future outbreaks.

In a September 2 announcement, the World Health Organization (WHO) highlighted the initiative, which was launched on August 27 and is funded by Gavi (the Vaccine Alliance) and coordinated through the International Coordinating Group (ICG) on Vaccine Provision, whose partners include WHO, UNICEF, Médecins Sans Frontières (MSF) and the International Federation of Red Cross and Red Crescent Societies (IFRC). The stockpile is scheduled to begin operations later this month and establishes a long-term mechanism for global mpox vaccine access and outbreak response.

“Establishing a dedicated global mpox vaccine stockpile is an important step forward in moving from reactive outbreak response toward sustained preparedness,” said David A. Dodd, Chairman and Chief Executive Officer of GeoVax. “Equitable access requires more than having vaccines available after an outbreak begins. It requires durable procurement infrastructure, sufficient vaccine supply, and the ability to rapidly deliver vaccine protection where it is needed. We applaud WHO, Gavi and the ICG partners for establishing this important mechanism and look forward to engaging with global health partners as our mpox vaccine candidate, GEO-MVA, advances toward pivotal Phase 3 evaluation and potential future supply.”

The new stockpile builds upon the Access and Allocation Mechanism established during the 2024 mpox public health emergency and responds to persistent barriers to vaccine access experienced during recent outbreaks. WHO has identified securing a robust product mix of vaccines and supplies and supporting market-shaping efforts to promote longer-term sustainable access to mpox vaccines among the stockpile’s strategic objectives. These objectives underscore the importance of reliable and diversified vaccine supply as part of sustained global preparedness.

The ICG mechanism has been used for decades to coordinate emergency vaccine supplies for epidemic-prone diseases. The addition of mpox establishes a durable framework through which international health organizations, donors, countries and vaccine manufacturers can support preparedness and rapid outbreak response.

GEO-MVA: Advancing Toward Pivotal Phase 3

GeoVax is developing GEO-MVA, a Modified Vaccinia Ankara (MVA)-based vaccine candidate for the prevention of mpox and smallpox. The Company has completed key manufacturing, regulatory, clinical and preclinical milestones supporting planned initiation of its pivotal Phase 3 immune-bridging study in the fourth quarter of 2026.

GEO-MVA program readiness includes:

  • Manufacturing Readiness: GMP clinical product has been manufactured, filled, packaged and released for use in the pivotal clinical study.
  • Regulatory Alignment: European Medicines Agency (EMA) Scientific Advice supports an expedited immune-bridging development pathway comparing GEO-MVA with the licensed MVA-BN vaccine.
  • Clinical Readiness: CRO engagement and clinical-site identification are advancing in support of the targeted approximately 500-participant pivotal study.
  • Preclinical Support: Comparative nonclinical studies have generated orthopoxvirus-specific immune responses and neutralizing-antibody data supporting the planned immune-bridging strategy.

As the new global stockpile infrastructure develops, GeoVax believes additional qualified MVA vaccine sources can help expand supply availability, manufacturing capacity and preparedness for future outbreaks. The Company is engaging government agencies and international preparedness organizations regarding future procurement requirements and the potential role of GEO-MVA as an additional source of MVA vaccine supply.

“Creating a sustainable procurement mechanism is an important part of preparedness, but preparedness also requires sufficient and reliable vaccine supply,” Dodd continued. “Our objective with GEO-MVA is to contribute a reliable additional source of MVA vaccine capacity that can strengthen global supply resilience and provide governments and international health organizations with greater supply flexibility.”

Extending Access Through Next-Generation MVA Technologies

Beyond advancing GEO-MVA toward potential registration and supply, GeoVax is pursuing technologies intended to address additional barriers to global vaccine access and administration. These efforts include development of MVA-X, a next-generation MVA vaccine approach targeting single-dose protection; advancement of continuous-cell-line manufacturing intended to support scalable production; and evaluation of microarray-based delivery technologies that could potentially simplify vaccine administration and facilitate broader deployment.

“The launch of this global stockpile represents a significant advance in the infrastructure for equitable mpox vaccine access and outbreak response,” Dodd said. “The next challenge is ensuring that the vaccines supporting that stockpile can be manufactured at scale and deployed as efficiently and broadly as possible. Our longer-term MVA strategy is focused on that entire continuum – from expanding supply, to pursuing single-dose protection, to simplifying how vaccines may ultimately be administered in the field.”

“As GEO-MVA progresses toward pivotal Phase 3 evaluation, we look forward to working with Gavi, WHO, the ICG and other international health organizations toward the shared objective of expanding sustainable and equitable access to mpox vaccines worldwide,” Dodd added.

About GEO-MVA

GEO-MVA is GeoVax’s Modified Vaccinia Ankara (MVA)-based vaccine being developed for protection against mpox and smallpox. Following Scientific Advice from the European Medicines Agency, GeoVax is pursuing an immune-bridging development strategy intended to compare immune responses generated by GEO-MVA with those generated by the licensed MVA-BN comparator.

GeoVax is developing GEO-MVA to expand global access to MVA vaccine supply and scalable production capabilities. The Company believes GEO-MVA has the potential to become an important strategic preparedness asset by providing governments and international public health organizations with an additional source of MVA vaccine supporting biosecurity and orthopoxvirus preparedness.

About GeoVax

GeoVax Labs, Inc. is a clinical-stage biotechnology company focused on the development of vaccines and immunotherapies addressing high-consequence infectious diseases and solid tumor cancers. GeoVax’s priority program is GEO-MVA, a Modified Vaccinia Ankara (MVA)–based vaccine targeting mpox and smallpox. The program is advancing under an expedited regulatory pathway, with plans to initiate a pivotal Phase 3 clinical trial in the fourth quarter of 2026, to address critical global needs for expanded orthopoxvirus vaccine supply and biodefense preparedness. In oncology, GeoVax is developing Gedeptin®, a gene-directed enzyme prodrug therapy (GDEPT) designed to enhance immune checkpoint inhibitor activity. Gedeptin has completed a multicenter Phase 1/2 clinical trial in advanced head and neck cancer and is being advanced into combination strategies, including planned neoadjuvant and first-line settings. GeoVax maintains a global intellectual property portfolio supporting its infectious disease and oncology programs and continues to evaluate strategic partnerships and funding opportunities aligned with its development priorities. For more information, visit www.geovax.com.

Forward-Looking Statements

This release contains forward-looking statements regarding GeoVax’s business plans. The words “believe,” “look forward to,” “may,” “estimate,” “continue,” “anticipate,” “intend,” “should,” “plan,” “could,” “target,” “potential,” “is likely,” “will,” “expect” and similar expressions, as they relate to us, are intended to identify forward-looking statements. We have based these forward-looking statements largely on our current expectations and projections about future events and financial trends that we believe may affect our financial condition, results of operations, business strategy and financial needs. Actual results may differ materially from those included in these statements due to a variety of factors, including whether: GeoVax is able to obtain acceptable results from ongoing or future clinical trials of its investigational products, GeoVax’s immuno-oncology products and preventative vaccines can provoke the desired responses, and those products or vaccines can be used effectively, GeoVax’s viral vector technology adequately amplifies immune responses to cancer antigens, GeoVax can develop and manufacture its immuno-oncology products and preventative vaccines with the desired characteristics in a timely manner, GeoVax’s immuno-oncology products and preventative vaccines will be safe for human use, GeoVax’s vaccines will effectively prevent targeted infections in humans, GeoVax’s immuno-oncology products and preventative vaccines will receive regulatory approvals necessary to be licensed and marketed, GeoVax raises required capital to complete development, there is development of competitive products that may be more effective or easier to use than GeoVax’s products, GeoVax will be able to enter into favorable manufacturing and distribution agreements, and other factors, over which GeoVax has no control.

Further information on our risk factors is contained in our periodic reports on Form 10-Q and Form 10-K that we have filed and will file with the SEC. Any forward-looking statement made by us herein speaks only as of the date on which it is made. Factors or events that could cause our actual results to differ may emerge from time to time, and it is not possible for us to predict all of them. We undertake no obligation to publicly update any forward-looking statement, whether as a result of new information, future developments or otherwise, except as may be required by law.

Company Contact:

[email protected]

678-384-7220

Media Contact:

Jessica Starman

[email protected]

Release – Kratos ARAV-B Ballistic Missile Target Successfully Utilized In Multinational Pacific Dragon 2026 Exercise

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September 9, 2026

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Photo: U.S. Navy (https://www.navy.mil/Press-Office/News-Stories/display-news/Article/4575192/us-allies-partners-executed-pacific-dragon-2026-exercise/?

Photo: U.S. Navy https://www.navy.mil/Press-Office/News-Stories/display-news/Article/4575192/us-allies-partners-executed-pacific-dragon-2026-exercise/

A photo accompanying this announcement is available at https://www.globenewswire.com/NewsRoom/AttachmentNg/fbcb4b4c-7855-4d5e-a594-3a8e193cab9b

SAN DIEGO, Sept. 09, 2026 (GLOBE NEWSWIRE) — Kratos Defense & Security Solutions, Inc. (Nasdaq: KTOS), a technology company in defense, national security, and global markets, today announced the successful mission of its Aegis Readiness Assessment Vehicle Type B (ARAV-B) ballistic missile target from the Pacific Missile Range Facility in Hawaii. The vehicle was fired on August 6 during Pacific Dragon 2026, a premier multinational ballistic missile defense (BMD) exercise led by the U.S. 3rd Fleet.

Photo: U.S. Navy https://www.dvidshub.net/image/9880612/arav-b-launch-during-pacific-dragon-2026

Photo: U.S. Navy https://www.dvidshub.net/image/9880612/arav-b-launch-during-pacific-dragon-2026

A photo accompanying this announcement is available at https://www.globenewswire.com/NewsRoom/AttachmentNg/e2c17ce8-d415-4f9b-95a6-a9f92ed3f8b7

The biennial exercise, which took place in the waters around the Hawaiian Islands from August 6-15, was designed to improve the ability of allied and partner forces to track and intercept ballistic missiles together. The multi-mission event combined coordinated missile defense operations with tactical data-link information sharing across forces from the United States, Australia, Chile, Italy, Japan, the Republic of Korea, and Spain, in conjunction with the U.S. Missile Defense Agency.

Kratos’ ARAV-B is part of the broader ARAV family of configurable short- and medium-range ballistic missile targets that can accurately emulate diverse and evolving threats. The ARAV Type B is a two-stage, spin-stabilized target featuring Kratos’ commercial Oriole rocket motor as the upper stage. The ARAV-B has now flown 43 successful target missions supporting the Naval Surface Warfare Center, Port Hueneme Division, White Sands Detachment and the Missile Defense Agency. Kratos’ commercially developed Oriole rocket motor, along with the larger Zeus family of rockets and the Erinyes hypersonic testbed vehicle demonstrate Kratos’ continuing commitment to investing in technologies and capabilities to serve the warfighter today.

Dave Carter, President of the Kratos Defense & Rocket Support Services (DRSS) Division, said, “Kratos is proud to support the U.S. 3rd Fleet and our allied partners in this critical demonstration of integrated air and missile defense capabilities. The successful launch of our ARAV-B target during Pacific Dragon 2026 highlights our team’s ability to rapidly develop and field affordable, threat-representative systems. By providing highly reliable target solutions, we ensure that advanced combat systems, such as the Baseline 10 and AN/SPY-6 radar on the USS Jack H. Lucas, are tested against the most realistic and demanding scenarios possible.”

The Kratos Ballistic Missile Defense target family includes multiple configurations beyond the Type B, such as the two-stage Type C vehicle and the three-stage Type TTO (Terrier-Terrier-Oriole). With their built-in modularity, these flight-proven Kratos systems can be rapidly reconfigured to support a range of missions including low-apogee, long duration hypersonic testing at speeds exceeding Mach 10.

Eric DeMarco, President and CEO of Kratos, said, “At Kratos, we are focused on delivering real, mission-relevant products and systems to our customers, not PowerPoints or concepts. We fundamentally believe that affordability is a technology, and we utilize our internal investments to bring national security relevant hardware to the field faster. By integrating existing assets and proven technologies, Kratos is first to market with cost-effective solutions that save our government customers and the U.S. taxpayer significant time and money. Our successful participation in Pacific Dragon 2026 is another testament to Kratos’ ability to execute on our strategy and deliver mission-critical solutions for global security.”

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 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 (C2) and telemetry, tracking and control (TT&C), 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 UAS, 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 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.

Press Contact: 
Claire Cantrell
[email protected]

Investor Relations: 
877-934-4687
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Release – Century Lithium Files Mine Plan of Operations for Angel Island Lithium Project in Nevada

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September 9, 2026 – Vancouver, Canada – Century Lithium Corp. (TSXV: LCE) (OTCQX: CYDVF) (Frankfurt: C1Z) (“Century Lithium” or “the Company”) is pleased to announce that it has submitted the Mine Plan of Operations (“PoO” or “Plan”) and Nevada Reclamation Permit Application for the Company’s 100%-owned Angel Island Mine Project (“Angel Island” or the “Project”) in Esmeralda County, Nevada, USA. The PoO was submitted on September 3, 2026, to the U.S. Bureau of Land Management (“BLM”), Battle Mountain District, Tonopah Field Office. The PoO is the proposed action for the Project and is the document upon which the BLM will base its environmental analyses under the National Environmental Policy Act (“NEPA”). It was prepared in accordance with BLM surface management regulations at 43 CFR Subpart 3809 and Nevada reclamation regulations at NAC 519A.

“The submission of the Mine Plan of Operations for Angel Island is a substantial milestone for Century Lithium,” said Bill Willoughby, President and CEO of Century Lithium. “It defines the Project the BLM will analyze, starts the clock on the environmental review, and reflects multiple years of baseline data collection, engineering, and coordination with the agencies. With the PoO completed, our focus turns to supporting the BLM and the third-party NEPA contractor toward a final Project approval through a Record of Decision.”

The PoO describes the mine, the processing plant, and the supporting infrastructure, and defines the process for reclamation of the land when mining is complete, and was submitted by the Company’s wholly owned subsidiary, Cypress Holdings (Nevada), Ltd., the operator of record for the Project.

The Angel Island Lithium Project

Angel Island is an advanced-stage, sedimentary lithium project located in Clayton Valley, Esmeralda County, Nevada, approximately six miles east of Silver Peak and 41 road-miles southwest of Tonopah. The Project Area covers 5,379 acres of BLM-administered public land held under federal mining claims. As described in the PoO, the proposed operation would result in approximately 2,364 acres of disturbance.

Key elements of the proposed operation, as set out in the PoO, include (see 2026FS):

  • Shallow Surface Mine. Lithium-bearing claystones allow mining in six pit phases with minimal overburden and low strip ratio. No drilling or blasting is anticipated; the ore will be ripped, loaded, and hauled to the processing facility.
  • Staged Growth. A two-phase development, with an initial production rate of approximately 8,300 tons per day (“tpd”) for the first four years of operation, increasing to a maximum of up to 16,500 tpd in years five through 40.
  • On-site Processing to Battery-grade Lithium Carbonate. Processing by agitated tank leaching, solid/liquid separation, Direct Lithium Extraction (“DLE”), and crystallization to produce battery-grade lithium carbonate. The process circuit is closed-loop and designed to operate with recycled water.
  • Salt-based Reagents. A chlor-alkali plant will produce hydrochloric acid and sodium hydroxide, both required by the process circuit, with surplus sodium hydroxide to be sold into the open market. Sodium hydroxide is a product of the processing circuit and is not derived from material mined from the Project.
  • Support Facilities. Included are two waste rock storage facilities, two low-grade ore stockpiles, a dry-stack tailings storage facility, heavy- and light-vehicle roads, and a warehouse, office, shop, and laboratory.
  • Grid Power. 53 MW in Phase 1 and 106 MW in Phase 2 are to be supplied by a transmission-voltage connection, with the Company’s preferred route tying into the new Esmeralda substation on the NV Energy Greenlink West corridor.
  • Water Supply. Process make-up water is to be obtained under the Company’s existing water rights from a well approximately 11 miles south of the Project and delivered to site via a buried 12-inch pipeline on BLM land, for which biological and cultural baseline surveys were completed.
  • Workforce. A workforce of approximately 275 full-time personnel is anticipated during operations, with a temporary peak of approximately 450 during construction.

Next Steps and Permitting Schedule

Angel Island is a Transparency Project under the Federal Permitting Improvement Steering Council’s FAST-41 program, with the BLM as lead agency. FAST-41 status provides coordinated federal oversight, publicly tracked milestones, and schedule transparency through the Permitting Dashboard for Federal Infrastructure Projects. The Permitting Dashboard currently shows an estimated completion date for environmental review and permitting of February 4, 2028. As with any federal schedule, the timetable may be adjusted as the review proceeds, and updates are posted on the Permitting Dashboard.

With the PoO submitted, the BLM will complete a 30-day regulatory review of the Plan for completeness and adequacy. Once the Plan is deemed complete, the third-party NEPA contractor will begin environmental analysis of the Project and will develop the Supplemental Information Report (“SIR”) and the Supplemental Environmental Reports (“SERs”) to support the NEPA document. Once the SIR and SERs are completed, the Administrative Environmental Impact Statement (“EIS”) can be prepared, after which the BLM is expected to publish a Notice of Intent in the Federal Register and initiate public scoping, ultimately leading to a Record of Decision (“ROD”). The anticipated sequence of milestones is summarized below.

MilestoneTargetStatus / Notes
PoO and Nevada Reclamation Permit Application submittedSeptember 3, 2026Completed
BLM completeness reviewQ4 2026In Progress
Notice of Intent published in Federal Register initiating public scoping periodQ2 2027Estimated
Additional baseline data collectionQ2 2027If required
Notice of Availability for EIS, ROD, and PoO published in Federal RegisterQ1 2028Anticipated
Note: Target dates are anticipated dates based on the schedule prepared for the Project by the Company, BLM, and the third-party contractor.

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In parallel with the federal process, the Company continues to advance state and local permitting in Nevada and prepare the Water Pollution Control Permit application package, which includes detailed engineering of Project components and facilities. Ongoing metallurgical test work continues in support of the Angel Island flowsheet, including definition of supporting project infrastructure, including power and water delivery.

Qualified Person

The scientific and technical information in this news release was reviewed and approved by William Willoughby, PhD, PE, President and Chief Executive Officer of Century Lithium Corp., who is a Qualified Person as defined by National Instrument 43-101 – Standards of Disclosure for Mineral Projects.

ABOUT CENTURY LITHIUM CORP.

Century Lithium Corp. is an advanced-stage lithium development company focused on its 100%-owned Angel Island lithium project in Esmeralda County, Nevada. Angel Island hosts one of the largest known sedimentary lithium deposits in the United States and is designed with an integrated, end-to-end process for the on-site production of battery-grade lithium carbonate to support the electric vehicle and battery storage markets.

The Company has developed a patent-pending process that incorporates hydrochloric acid leaching combined with direct lithium extraction to produce battery-grade lithium carbonate. As part of the integrated chlor-alkali process, Angel Island is designed to produce sodium hydroxide as a co-product, with planned surplus sales expected to lower operating costs, reduce reliance on externally sourced reagents, and minimize environmental impacts.

Century Lithium is currently advancing Angel Island through the permitting process.

All inferences to mining, processing and economics for Angel Island herein are from the Updated NI 43-101 Technical Report on the Feasibility of the Clayton Valley Lithium Project, Esmeralda County, Nevada, USA, January 3, 2026 (“2026FS”), which is available on SEDAR+ and the Company’s website.

Century Lithium trades on the TSX Venture Exchange under the symbol “LCE” the OTCQX under the symbol “CYDVF” and on the Frankfurt Stock Exchange under the symbol “C1Z”.

To learn more, please visit centurylithium.com.

ON BEHALF OF CENTURY LITHIUM CORP.

WILLIAM WILLOUGHBY, PhD., PE
President & Chief Executive Officer

For further information, please contact:
Spiros Cacos | Vice President, Investor Relations
Direct: +1 604 764 1851
Toll Free: 1 800 567 8181
[email protected]
centurylithium.com

NEITHER THE TSX VENTURE EXCHANGE NOR ITS REGULATION SERVICES PROVIDER ACCEPTS RESPONSIBILITY FOR THE ADEQUACY OR ACCURACY OF THE CONTENT OF THIS NEWS RELEASE.

Cautionary Note Regarding Forward-Looking Statements

This release contains certain forward-looking statements within the meaning of applicable Canadian securities legislation. In certain cases, forward-looking statements can be identified by the use of words such as “plans”, “expects” 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” or “will be taken”, “occur” or “be achieved” and similar expressions suggesting future outcomes or statements regarding an outlook.

Forward-looking statements relate to any matters that are not historical facts and statements of our beliefs, intentions and expectations about developments, results and events which will or may occur in the future, without limitation, statements with respect to the potential development and value of the Project and benefits associated therewith, statements with respect to the expected project economics for the Project, such as estimates of life of mine, lithium prices, production and recoveries, capital and operating costs, IRR, NPV and cash flows, any projections outlined in the Feasibility Study in respect of the Project, the permitting status of the Project and the Company’s future development plans.

These and other forward-looking statements and information are subject to various known and unknown risks and uncertainties, many of which are beyond the ability of the Company to control or predict, that may cause their actual results, performance or achievements to be materially different from those expressed or implied thereby, and are developed based on assumptions about such risks, uncertainties and other factors set out herein. These risks include those described under the heading “Risk Factors” in the Company’s most recent annual information form and its other public filings, copies of which can be under the Company’s profile at www.sedarplus.ca. The Company expressly disclaims any obligation to update-forward-looking information except as required by applicable law. No forward-looking statement can be guaranteed, and actual future results may vary materially. Accordingly, readers are advised not to place reliance on forward-looking statements or information. Furthermore, Mineral Resources that are not Mineral Reserves do not have demonstrated economic viability.

Release – Eledon Pharmaceuticals Announces Presentation at the International Congress of The Transplantation Society

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September 9, 2026

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IRVINE, Calif., Sept. 09, 2026 (GLOBE NEWSWIRE) — Eledon Pharmaceuticals, Inc. (“Eledon”) (Nasdaq: ELDN) today announced an oral presentation highlighting the long-term safety and efficacy of tegoprubart in preventing kidney transplant rejection will take place at the upcoming International Congress of The Transplantation Society in Sydney, Australia, from September 20–23, 2026.

Details of the presentation are below:

Oral Presentation

Title: Phase 2 BESTOW trial and the BESTOW EXTENSION: Evaluating the long-term safety and efficacy of tegoprubart in preventing kidney transplant rejection

Presenter: Andrew Adams, M.D., Ph.D., Professor of Surgery and Chief Division of Transplantation, John S. Najarian Surgical Chair in Clinical Transplantation, Department of Surgery, University of Minnesota; Executive Medical Director, Solid Organ Transplant Service Line, M Health Fairview

Session Title: Novel immunosuppression

Session Date and Time: Tuesday, September 22, 2026, from 8:00AM to 9:00AM AEST

Session Room: Room C4.9

Presentation Time: 8:00AM AEST

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; X

Investor Contact:

Stephen Jasper
Gilmartin Group
(858) 525 2047
[email protected]

Media Contact:

Jenna Urban
CG Life
(212) 253 8881
[email protected]

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Release – Cocrystal Pharma Announces Last Subject Dosed in Phase 1b Human Challenge Study Evaluating CDI-988 for Norovirus Prevention and Treatment

Cocrystal Pharma, Inc.

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September 09, 2026

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No serious adverse events reported to date

Preliminary efficacy results expected in late 2026 or early 2027

MIAMI, Fla. And BOTHELL, Wash., Sept. 09, 2026 (GLOBE NEWSWIRE) — Cocrystal Pharma, Inc. (Nasdaq: COCP) (“Cocrystal” or the “Company”), a biotechnology company developing novel therapeutics to meet the growing global need for effective, safe antiviral treatments, today announced that the last subject has been dosed in its Phase 1b norovirus challenge study (NCT07198139) evaluating CDI-988 as both a preventive and treatment for norovirus infections.

CDI-988 is the first oral antiviral drug candidate developed for norovirus acute gastroenteritis and is designed to inhibit viral replication in all known norovirus strains. CDI-988 completed a Phase 1 clinical trial in Australia, with data showing CDI-988 was safe and well tolerated in humans, with no serious adverse events reported.

“Completion of this critical milestone brings us closer to addressing one of the most pressing unmet needs in infectious disease,” said James Sapirstein, Chief Executive Officer of Cocrystal Pharma. “Norovirus imposes an enormous burden on patients and health systems, with particular risk in settings such as hospitals, nursing homes, cruise ships, schools and military facilities. We look forward to reporting preliminary results near the end of 2026 or early 2027 and to advancing CDI-988 as a potential first-in-class oral antiviral for norovirus.”

The Phase 1b randomized, double-blind, placebo-controlled study was conducted at Emory University School of Medicine and enrolled healthy subjects ages 18-49, who were infected with the norovirus GII.2 (Snow Mountain Virus) strain and orally administered CDI-988 or placebo. The primary endpoint is efficacy versus placebo in reducing the incidence of clinical symptoms. Secondary endpoints include reduction of viral shedding and disease severity, as well as safety and pharmacokinetic profiles.

“Reaching last-subject-dosed in the first clinical trial of a direct-acting antiviral specifically targeting norovirus is a significant achievement for our team,” said Sam Lee, Ph.D., President and Chief Scientific Officer of Cocrystal Pharma. “The efficacy and safety data from this study are expected to provide a strong rationale for further clinical advancement of CDI-988.”

CDI-988 previously demonstrated favorable safety and tolerability in a Phase 1 study across all dose levels, including the highest dose of 1200 mg administered. The 1200 mg dose, established as safe in the earlier Phase 1 dose-escalation study in healthy volunteers conducted in Australia, is the dose being administered to healthy volunteers who are then infected with norovirus in the ongoing Phase 1b challenge study.

About Norovirus

With an estimated 685 million global cases annually and a $60 billion worldwide economic impact, norovirus represents one of healthcare’s most pressing unmet needs. In the U.S., noroviruses are responsible for an estimated 21 million infections annually, including 109,000 hospitalizations, 465,000 emergency department visits and an estimated 900 deaths. The annual burden of norovirus to the U.S. is estimated at $10.6 billion. Noroviruses are responsible for up to 1.1 million hospitalizations and 218,000 deaths annually in children in the developing world.

About Cocrystal Pharma, Inc.

Cocrystal Pharma, Inc. is a clinical-stage biotechnology company discovering and developing novel antiviral therapeutics that target the replication process of noroviruses, influenza viruses, coronaviruses (including SARS-CoV-2), and hepatitis C viruses. Cocrystal employs unique structure-based technologies to create viable antiviral drugs. For more information, visit www.cocrystalpharma.com.

Cautionary Note Regarding Forward-Looking Statements

This press release contains forward-looking statements within the meaning of the Private Securities Litigation Reform Act of 1995, including statements regarding the advancing of CDI-988 as a potential first-in-class oral antiviral for norovirus. Words such as “believe,” “may,” “estimate,” “continue,” “anticipate,” “intend,” “should,” “plan,” “could,” “target,” “potential,” “is likely,” “will,” and “expect,” as they relate to the Company, are intended to identify forward-looking statements. We have based these forward-looking statements largely on our current expectations and projections about future events. Some or all of the events anticipated by these forward-looking statements may not occur. Important factors that could cause actual results to differ from those in the forward-looking statements include, but are not limited to, the risks and uncertainties arising from inflation, affordability, the possibility of a recession, increases or other developments with respect to interest rates, uncertainty surrounding the impacts arising from imposed and threatened tariffs and developments with respect thereto, and wars and geopolitical conflicts including those in Ukraine and with Iran on our Company, our collaboration partners, and on the U.S. and global economies, including manufacturing and research delays arising from raw materials and labor shortages, supply chain disruptions and other business interruptions including any adverse impacts on our ability to obtain raw materials and test animals as well as similar problems with our vendors our and our collaboration partners’ technology and software performing as expected, financial difficulties experienced by certain partners, risks arising from the research into a related virus was not done in animals and was necessarily early stage, the results of future preclinical and clinical trials, general risks arising from clinical trials, receipt of regulatory approvals, regulatory changes and potential litigation challenging initiatives and actions taken by the Trump Administration which could, among other things, result in delays in regulatory approvals or limit access to federal funding for our programs, development of effective treatments and/or vaccines by competitors, including as part of the programs financed by the U.S. government, potential mutations in a virus we are targeting which may result in variants that are resistant to a product candidate we develop, and our liquidity. Further information on our risk factors is contained in our filings with the SEC, including the “Risk Factors” in Item 1A of our Annual Report on Form 10-K for the year ended December 31, 2025. Any forward-looking statement made by us herein speaks only as of the date on which it is made. Factors or events that could cause our actual results to differ may emerge from time to time, and it is not possible for us to predict all of them. We undertake no obligation to publicly update any forward-looking statement, whether as a result of new information, future developments or otherwise, except as may be required by law.

Investor Contact:
Nicolas Johnson
Russo Partners
[email protected]
(303) 482-6405

Media Contact:
David Schull
Russo Partners
[email protected]
(858) 717-2310