Includes Full Exercise of $15.0 million Over-Allotment Option
MALVERN, Pa., May 14, 2026 (GLOBE NEWSWIRE) — Ocugen, Inc. (Ocugen or the Company) (NASDAQ: OCGN), a pioneering biotechnology leader in gene therapies for blindness diseases, today announced the closing of $130.0 million aggregate principal amount of 6.75% Convertible Senior Notes due 2034 (the “notes”) in a private offering (the “offering”) to qualified institutional buyers pursuant to Rule 144A under the Securities Act of 1933, as amended (the “Securities Act”), including the full exercise by the initial purchaser of its option to purchase an additional $15.0 million aggregate principal amount of the notes. The sale of the notes is expected to result in approximately $112.6 million in net proceeds to Ocugen after deducting the initial purchaser’s discount and estimated offering expenses payable by Ocugen.
The offering price of the notes was 90% of the principal amount of the notes. Ocugen used approximately $32.7 million of the net proceeds from the offering to fully repay the outstanding principal amount of, plus accrued and unpaid interest on, the loan outstanding under its Loan and Security Agreement with affiliates of Avenue Capital Group (the “Avenue Loan Agreement”), and pay the related prepayment fee and other fees and expenses in connection therewith. Ocugen expects to use the remaining net proceeds from the offering for general corporate purposes.
“This financing milestone reflects the strong momentum we have built across our late-stage pipeline and our unwavering commitment to the patients we serve,” said Dr. Shankar Musunuri, Chairman, Chief Executive Officer, and Co-founder of Ocugen. “With our anticipated cash runway extended into 2028, we are well-positioned to advance three late-stage programs and execute toward our goal of filing three BLAs by 2028, bringing potentially transformative therapies to patients who have long awaited meaningful treatment options.”
AboutOcugen,Inc. Ocugen, Inc. is a pioneering biotechnology leader in gene therapies for blindness diseases. Our breakthrough modifier gene therapy platform has the potential to address significant unmet medical need for large patient populations through our gene-agnostic approach. Unlike traditional gene therapies and gene editing, Ocugen’s modifier gene therapies address the entire disease—complex diseases that are potentially caused by imbalances in multiple gene networks. Currently we have programs in development for inherited retinal diseases and blindness diseases affecting millions across the globe, including retinitis pigmentosa, Stargardt disease, and geographic atrophy—late-stage dry age-related macular degeneration. Discover more at www.ocugen.com and follow us on X and LinkedIn.
CautionaryNoteonForward-LookingStatements This press release contains forward-looking statements within the meaning of The Private Securities Litigation Reform Act of 1995, which are subject to risks and uncertainties, including but not limited to, statements regarding the anticipated use of proceeds from the offering, Ocugen’s anticipated cash runway, the timing of future BLA filings, the potential to bring therapies to patients, and other statements contained in this press release that are not historical facts. Ocugen may, in some cases, use terms such as “predicts,” “believes,” “potential,” “proposed,” “continue,” “estimates,” “anticipates,” “expects,” “plans,” “intends,” “may,” “could,” “might,” “will,” “should,” or other words that convey uncertainty of future events or outcomes to identify these forward-looking statements. Such statements are subject to numerous important factors, risks, and uncertainties that may cause actual events or results to differ materially from Ocugen’s current expectations, including, but not limited to: risks related to the offering and uncertainties related to market conditions; the impact of the offering on the market price of Ocugen’s common stock; and risks related to the potential dilution to holders of Ocugen’s common stock. These and other risks and uncertainties are more fully described in Ocugen’s periodic filings with the Securities and Exchange Commission (SEC), including the risk factors described in the section entitled “Risk Factors” in the quarterly and annual reports that Ocugen files with the SEC. Any forward-looking statements that Ocugen makes in this press release speak only as of the date of this press release. Except as required by law, Ocugen assumes no obligation to update forward-looking statements contained in this press release whether as a result of new information, future events, or otherwise, after the date of this press release.
Completed successful End-of-Phase 2 meeting with the FDA and selected onvansertib dose and chemotherapy regimen for planned Phase 3 trial
Company to provide detailed data update from Phase 2 CRDF-004 trial in rapid oral presentation at American Society of Clinical Oncology Annual Meeting
Leadership additions position Company to execute on key upcoming clinical and regulatory milestones
SAN DIEGO, May 14, 2026 (GLOBE NEWSWIRE) — Cardiff Oncology, Inc. (Nasdaq: CRDF), a clinical-stage biotechnology company leveraging PLK1 inhibition to develop novel cancer therapies, today announced financial results for the first quarter ended March 31, 2026, and provided a business update.
“This quarter was marked by the positive data update from our randomized Phase 2 CRDF-004 trial of onvansertib in first-line RAS-mutated metastatic colorectal cancer, along with key leadership additions that prepare the Company to deliver on the clinical milestones ahead,” said Mani Mohindru, PhD, President and Chief Executive Officer of Cardiff Oncology.
“In April, we had a successful End-of-Phase 2 meeting with the FDA and aligned on the key design elements for our Phase 3 registrational trial. We plan to share additional Phase 3 details and our regulatory strategy in mid-2026. At the upcoming ASCO Annual Meeting, we will present updated CRDF-004 data, which we believe will provide further insight into onvansertib’s potential in the first-line RAS-mutated metastatic colorectal cancer (mCRC) setting. In parallel, we continue to strengthen the scientific foundation of our PLK1 inhibition strategy, supported by new preclinical data evaluating combination use with an antibody-drug conjugate, as well as ongoing single-agent and combination investigator-initiated studies across multiple cancer settings. With strong clinical momentum, we remain focused on disciplined execution throughout the year.”
Clinical Highlights
Upcoming Event: Reporting Updated Onvansertib Data in Rapid Oral Presentation at American Society of Clinical Oncology (ASCO) Annual Meeting 2026
The Company will report detailed updated data from its randomized Phase 2 CRDF-004 trial evaluating onvansertib in combination with FOLFIRI/bev or FOLFOX/bev in patients with first-line RAS-mutated mCRC in a rapid oral presentation at the ASCO Annual Meeting, taking place May 29–June 2 in Chicago. More information about the presentation is available here.
Completed End-of-Phase 2 Meeting with the FDA and Aligned on the Design of the Phase 3 Registrational Trial in Patients with First-line RAS-mutated mCRC
In consultation with the U.S. Food and Drug Administration (FDA), Cardiff selected the 30 mg dose of onvansertib for evaluation with FOLFIRI/bev chemotherapy regimen for the Phase 3 trial in patients with first-line RAS-mutated mCRC. Additional details of the clinical trial will be shared by mid-2026.
Key Opinion Leader Engagements Highlight Onvansertib Clinical Data and Opportunity in mCRC
In March, Cardiff hosted a KOL webinar featuring internationally recognized leaders in colorectal cancer research, Drs. Scott Kopetz and Heinz-Josef Lenz. The webinar focused on the evolving treatment landscape in first-line RAS-mutated mCRC and onvansertib’s potential as a novel therapeutic approach in the management of RAS-mutated mCRC. A replay of the webcast is available in the Events section of the Company’s website.
Announced Positive Update from our Randomized Phase 2 Trial of Onvansertib in First-line RAS-mutated mCRC
In January, Cardiff provided topline data from its ongoing CRDF-004 Phase 2 randomized clinical trial in first-line RAS-mutated mCRC. The 30 mg onvansertib + FOLFIRI/bevacizumab (bev) arm achieved a confirmed objective response rate (ORR) of 72.2% compared to 43.2% across the combined standard-of-care (SoC) arms. The 30 mg onvansertib dose in combination with FOLFIRI/bev also demonstrated marked improvement in progression-free survival (PFS) versus FOLFIRI/bev (HR: 0.38) and combined SoC of FOLFOX/bev and FOLFIRI/bev (HR: 0.37, p<0.05), with no significant added toxicity observed. More details available here.
Preclinical Highlights
Company Presented New Preclinical Data at the 2026 American Association for Cancer Research (AACR) Annual Meeting Supporting Rationale for Onvansertib in Combination with Antibody Drug Conjugates
Cardiff presented new preclinical data at the AACR Annual Meeting in April demonstrating that onvansertib enhanced the activity of the HER2-targeted antibody-drug conjugate trastuzumab deruxtecan (T-DXd), driving tumor regression and overcoming resistance in HER2-low breast cancer models. More details are available here.
Corporate Update
Key Leadership Appointments Strengthen Executive Team to Support Company’s Next Phase of Growth
In April, the Company announced the appointment of Mani Mohindru, PhD, as President and Chief Executive Officer (CEO), following her time as Interim CEO. She will continue as a member of the Board of Directors. The Company also appointed Josh Muntner as Chief Financial Officer and Ajay Aggarwal, MD, MBA, as Chief Operating Officer, effective April 6 and April 27, respectively. Together, these appointments reflect Cardiff’s commitment to building an experienced leadership team to advance onvansertib and deliver on the program’s long-term potential.
First Quarter 2026 Financial Results
Liquidity, cash burn, and cash runway
As of March 31, 2026, Cardiff Oncology had approximately $46.1 million in cash, cash equivalents, and short-term investments.
Net cash used in operating activities for the first quarter of 2026 was approximately $12.3 million, a decrease of approximately $0.5 million from $12.8 million for the same period in 2025.
Based on its current expectations and projections, the Company believes its current cash resources are sufficient to fund its operations into the first quarter of 2027.
Operating results
Total operating expenses were approximately $12.9 million for the three months ended March 31, 2026, a decrease of $1.6 million from $14.5 million for the same period in 2025. The decrease in operating expenses was primarily due to a decrease of $3.7 million in R&D expenses, mainly clinical trial expenses and preclinical activities, partially offset by an increase of $2.1 million in SG&A expenses, primarily for employee severance agreements and corresponding modifications of stock options.
About Cardiff Oncology, Inc. Cardiff Oncology is a clinical-stage biotechnology company advancing innovative cancer treatments focused on PLK1 inhibition, a validated oncology target with practice-changing potential. Our lead asset, onvansertib, is a highly specific, oral PLK1 inhibitor currently being evaluated in a Phase 2 trial for first-line treatment of RAS-mutated metastatic colorectal cancer (mCRC), addressing a large, underserved patient population with high unmet need. Onvansertib is also under investigation in other PLK1-driven cancers through ongoing investigator-initiated trials and has shown robust single agent clinical activity in hard-to-treat tumors. By targeting tumor vulnerabilities, we aim to overcome treatment resistance and deliver improved clinical outcomes for patients.
Forward-Looking Statements Certain statements in this press release are forward-looking within the meaning of the Private Securities Litigation Reform Act of 1995. These statements may be identified using words such as “anticipate,” “believe,” “forecast,” “estimated” and “intend” or other similar terms or expressions that concern Cardiff Oncology’s expectations, strategy, plans or intentions. These forward-looking statements are based on Cardiff Oncology’s current expectations and actual results could differ materially. There are several factors that could cause actual events to differ materially from those indicated by such forward-looking statements. These factors include, but are not limited to, clinical trials involve a lengthy and expensive process with an uncertain outcome, and results of earlier studies and trials may not be predictive of future trial results; our clinical trials may be suspended or discontinued due to unexpected side effects or other safety risks that could preclude approval of our product candidate; results of preclinical studies or clinical trials for our product candidate could be unfavorable or delayed; our need for additional financing; risks related to business interruptions, including the outbreak of COVID-19 coronavirus and cyber-attacks on our information technology infrastructure, which could seriously harm our financial condition and increase our costs and expenses; uncertainties of government or third party payer reimbursement; dependence on key personnel; limited experience in marketing and sales; substantial competition; uncertainties of patent protection and litigation; dependence upon third parties; and risks related to failure to obtain FDA clearances or approvals and noncompliance with FDA regulations. There are no guarantees that our product candidate will be utilized or prove to be commercially successful. Additionally, there are no guarantees that future clinical trials will be completed or successful or that our product candidate will receive regulatory approval for any indication or prove to be commercially successful. Investors should read the risk factors set forth in Cardiff Oncology’s Form 10-K for the year ended December 31, 2025, and other periodic reports filed with the Securities and Exchange Commission. While the list of factors presented here is considered representative, no such list should be considered to be a complete statement of all potential risks and uncertainties. Unlisted factors may present significant additional obstacles to the realization of forward-looking statements. Forward-looking statements included herein are made as of the date hereof, and Cardiff Oncology does not undertake any obligation to update publicly such statements to reflect subsequent events or circumstances.
Company Reports Quarterly Revenues of $51.7 million, a 14.0% Year-Over-Year Increase
Broadcast Revenues Increase to $43.7 million, a 20.8% Increase Year-Over-Year
Company Reaffirms Full-Year 2026 Revenue Guidance, Representing Accelerated Year-Over-Year Growth of 13% at the Midpoint
BOCA RATON, FL / ACCESS Newswire / May 14, 2026 / Newsmax Inc. (NYSE:NMAX) (“Newsmax” or the “Company”) today announced its financial results for the first quarter ended March 31, 2026.
First Quarter 2026 Business and Operational Highlights
Delivered broad first quarter audience reach, with 30.4 million total viewers and 13.3 million Adults 35-64, reinforcing Newsmax’s position as the fourth highest-rated cable news channel and a top fifteen cable network across key dayparts.
Continued to strengthen the Company’s multi-platform audience ecosystem, with social media followers rising to 24.7 million as of March 31, 2026.
Increased content offering through continued investment in Newsmax+ and in premium programming, including the expansion of World at War / War & Warriors, where available titles increased more than 200%.
Continued to advance our international growth strategy by expanding our licensing agreement with Telecom Serbia and Newsmax Poland.
Management Commentary
“Newsmax delivered a strong start to 2026, with broad audience reach across cable, streaming and digital while continuing to strengthen the scale of our platform,” said Christopher Ruddy, Chief Executive Officer of Newsmax. “In the first quarter, we increased viewership, gained traction with younger demographics and saw continued momentum across Newsmax2, Newsmax+ and social media. While the industry is lapping unusually high election-driven news consumption from early 2025, our first quarter rankings demonstrate that Newsmax continues to perform strongly in a more normalized environment. We are also making further strides as a global news brand and continuing to attract unique viewers that reinforce the significant opportunity we see in the under-served center-right market. These results reflect the strength of our brand, the loyalty of our audience and the value of our multi-platform strategy.”
“Looking ahead, we see meaningful opportunity to build on this momentum through continued investment in content, broader distribution and deeper audience engagement across all of our platforms,” Ruddy continued. “As the media landscape evolves, we believe Newsmax is well positioned to expand its reach, strengthen monetization and deliver sustainable long-term growth by providing independent, values-driven journalism that resonates with viewers in the United States and around the world.”
“Our first quarter results reflect continued progress in executing our growth strategy,” commented Darryle Burnham, Chief Financial Officer of Newsmax. “We saw solid revenue growth driven by affiliate fees and licensing, while we continue to invest behind this growth in programming, production and our OTT initiatives to support long-term expansion. With a strong balance sheet and disciplined approach to capital allocation, we remain confident in our financial outlook and are maintaining our full-year guidance as we continue to invest in initiatives that drive sustainable, long-term shareholder value.”
Financial Results:
Revenue by Segment by Component Table (unaudited):
First Quarter 2026 Financial Highlights:
Newsmax reported total quarterly revenues of $51.7 million for the three-month period ended March 31, 2026, representing a 14.0% year-over-year increase.
Total broadcasting revenues grew 20.8% year-over year to $43.7 million for the first quarter of 2026, primarily driven by an increase in affiliate fee revenue attributed to timing of new contractual relationships and expanded international licensing agreements.
Newsmax reported a quarterly net loss of $(2.2) million as compared to a net loss of $(17.2) million reported in same quarter in the prior year, primarily driven by higher total revenue, lower legal expenses and improved other income, partially offset by higher production headcount, programming and production costs, continued investment in Newsmax2 and higher stock-based compensation.
Quarterly adjusted EBITDA was $(0.4) million, a decrease of $(0.8) million from the amount reported in the same quarter last year, primarily due to higher production, programming and personnel costs to support ongoing content and OTT investment, partially offset by growth in affiliate fee revenue in the broadcast segment. See reconciliation of net loss to adjusted EBITDA below.
The Company ended the quarter with $129.1 million in cash and short-term investments. Cash and cash equivalents were $17.2 million and short-term investments were $111.9 million.
The Company is reiterating its previously issued full-year 2026 revenue guidance of $212 million to $216 million, representing 13% year-over-year growth at the midpoint of the range.
About Newsmax
Newsmax Inc. is listed on the NYSE (NMAX) and operates, through Newsmax Broadcasting LLC, one of the nation’s leading news outlets, the Newsmax channel. The fourth highest-rated network is carried on all major pay TV providers. Newsmax’s media properties reach more than 50 million Americans regularly through Newsmax TV, the Newsmax App, its popular website Newsmax.com, and publications such as Newsmax Magazine. Through its social media accounts, Newsmax reaches over 25 million combined followers. Reuters Institute says Newsmax is one of the top U.S. news brands and Forbes has called Newsmax “a news powerhouse.”
This communication contains forward-looking statements. From time to time, we or our representatives may make forward-looking statements orally or in writing. We base these forward-looking statements on our expectations and projections about future events, which we derive from the information currently available to us. Forward-looking statements can be identified by those that are not historical in nature. The forward-looking statements discussed in this communication and other statements made from time to time by us or our representatives, may not occur, and actual events and results may differ materially and are subject to risks, uncertainties and assumptions about us. Newsmax does not guarantee future results, performance or achievements. Moreover, neither we nor any other person assumes responsibility for the accuracy or completeness of any of these forward-looking statements. Forward-looking statements should not be relied upon as predictions of future events. We are under no duty to update any of these forward-looking statements after the date of this communication to conform our prior statements to actual results or revised expectations, and we do not intend to do so. Factors that may cause actual results to differ materially from current expectations include various factors, including but not limited changes in domestic and global general economic and macro-economic conditions and the volatility of the price of Common Stock that may result from, among other things, comments by securities analysts or other third parties, including blogs, articles, message boards and social and other media, large shareholders exiting their position in our Common Stock, any negative public perception of us, sales of shares previously registered for resale, or other uncertainties and the factors set forth in the sections entitled “Risk Factors” in Newsmax’s Annual Report on Form 10-K for the twelve months ended December 31, 2025 and other filings Newsmax makes with the Securities and Exchange Commission. Nothing in this communication should be regarded as a representation by any person that the forward-looking statements set forth herein will be achieved or that any of the contemplated results of such forward-looking statements will be achieved. Undue reliance should not be placed on forward-looking statements in this communication, which speak only as of the date they are made and are qualified in their entirety by reference to the cautionary statements herein.
USE AND DEFINITION OF NON-GAAP FINANCIAL MEASURES
This press release contains a financial measure that has not been prepared in accordance with United States Generally Accepted Accounting Principles (“U.S. GAAP”). This financial measure is Adjusted EBITDA.
Non-GAAP financial measures are used to supplement the financial information presented on a U.S. GAAP basis and should not be considered in isolation or as a substitute for the relevant U.S. GAAP measures and should be read in conjunction with information presented on a U.S. GAAP basis. Because not all companies use identical calculations, our presentation of Non-GAAP measures may not be comparable to other similarly titled measures of other companies.
Adjusted EBITDA1 is defined as revenues less cost of revenues and general and administrative expenses and does not include depreciation, amortization related to the incremental costs to obtain a contract, interest expense, net, impairment charges, unrealized gains (losses) on marketable securities, stock-based compensation, other corporate matters (consisting primarily of certain litigation expenses, and related fees, for specific legal proceedings that the Company has determined are infrequent and unusual in terms of their magnitude), other, net, and income tax expense.
You are encouraged to evaluate each adjustment used in calculating our non-GAAP financial measure and the reasons we consider our non-GAAP financial measure appropriate for supplemental analysis. In evaluating our non-GAAP financial measure, you should be aware that in the future we may incur expenses similar to the adjustments in our presentation. Our non-GAAP financial measure has limitations as an analytical tool, and you should not consider this measure in isolation or as a substitute for analysis of our results as reported under GAAP. Our presentation of our non-GAAP financial measure should not be construed as an inference that our future results will be unaffected by unusual or non-recurring items. Our non-GAAP financial measure may not be comparable to other companies. Please see a historical reconciliation of this measure to the most comparable GAAP measure presented in our consolidated financial statements below.
1 The Company compensates for limitations of the adjusted EBITDA measure by prominently disclosing GAAP net loss, which the Company believes is the most directly comparable GAAP measure, and providing investors with a reconciliation from GAAP net loss to adjusted EBITDA.
Net income increased 25% year-over-year to $2.3M; year-to-date net income grew 78% to $16.6M
Adjusted EBITDA increased to $5.1M in Q3; year-to-date Adjusted EBITDA up 47% to $35.7M
PLANTATION, Fla., May 14, 2026 (GLOBE NEWSWIRE) — Alliance Entertainment Holding Corporation (Nasdaq: AENT), a premier distributor, logistics provider, and omnichannel fulfillment partner to the entertainment and pop culture collectibles industry, supplying more than 340,000 unique SKUs across music, video, video games, licensed merchandise, and exclusive collectibles to over 35,000 retail and e-commerce storefronts, reported its financial and operational results for its fiscal third quarter ended March 31, 2026.
Third Quarter FY 2026 Highlights
Revenue Growth and Sustained Profitability: Net revenues increased 21.2% year-over-year to $258.2 million, driven by broad-based strength across core physical product categories. Net income increased to $2.3 million, or $0.05 per diluted share, compared to $1.9 million, or $0.04 per share, in the prior-year period, reflecting continued execution against the Company’s profitability framework. Adjusted EBITDA was approximately $5.1 million, compared to $4.9 million in Q3 FY25. For the nine months ended March 31, 2026, net revenues increased 5% to $880.9 million, compared to $835.7 million in the prior-year period, while net income increased 78% to $16.6 million, or $0.32 per diluted share, compared to $9.3 million, or $0.18 per share. Adjusted EBITDA was approximately $35.7 million, up 47% from $24.4 million in the prior-year period.
Launch of Endstate Authentic and Alliance Authentic™: The Company continued to advance its technology strategy following the acquisition of Endstate on December 31, 2025, establishing Endstate Authentic, an NFC-enabled authentication and digital product identity platform that supports authenticated ownership, provenance, and verified resale across premium physical goods. During the quarter, Alliance also launched Alliance Authentic™, representing the Company’s first application of these capabilities within its own product ecosystem, initially focused on premium vinyl collectibles. The platform has since expanded to include additional categories, including Handmade by Robots™ and select third-party collectibles such as Funko figures. These initiatives extend Alliance’s role beyond distribution into ownership and participation across the product lifecycle, while creating a scalable foundation for new authentication, collectibles, and platform revenue opportunities.
Strength in Physical Media: Vinyl record sales increased 15% year-over-year to $99 million, driven by higher unit volumes and sustained interest in limited-edition releases. Compact disc (CD) sales increased 90% year-over-year to $39 million, reflecting both higher unit volumes and improved pricing, driven by strong demand for major releases and collectible formats, including continued strength in international and K-pop titles. Physical movie sales increased 5% year-over-year to $61 million, supported by a steady cadence of new releases and continued consumer demand for premium formats such as 4K Ultra HD and collectible editions. Performance in the category continued to benefit from the Company’s exclusive studio partnerships, including Paramount and Amazon MGM Studios Distribution, which expanded title availability and supported growth across key retail channels.
Collectibles Growth Driven by Premium Mix: Collectibles revenue increased 48% year-over-year to $8 million, driven by increased average selling prices and a continued shift toward higher-value, premium products. Growth was supported by expanded sourcing efforts and the addition of new vendor relationships, which contributed incremental sales during the quarter. Performance also benefited from the transition of Handmade by Robots™ to an owned brand, as well as improved margins across certain legacy brands following prior inventory optimization initiatives, reflecting continued progress in enhancing product mix and profitability within the collectibles category.
Growth in Gaming and Electronics: Gaming revenue increased 12% year-over-year to $33 million, supported by continued demand for next-generation consoles, including the Nintendo Switch II, along with related software and accessories. Electronics revenue increased 53% year-over-year to $4.0 million, driven by higher unit volumes and a favorable mix shift toward higher-priced audio playback devices and accessories, including turntables, CD players, headphones, and speakers. Growth in electronics continued to benefit from strong demand for vinyl and physical media, which drives attachment sales of complementary hardware. Performance in both categories reflects the Company’s ability to align product mix with evolving consumer preferences while capturing incremental demand across hardware and content ecosystems.
Operating Leverage and Expense Discipline: Total operating expenses improved to 11.5% of net revenue, compared to 12.0% in the prior-year period. Selling, general and administrative expenses improved to 6.5% of net revenue, compared to 6.7% in the prior year, while distribution and fulfillment expenses declined to 4.3% of net revenue, compared to 4.7% in Q3 FY25. The improvement was driven by higher revenue scale, productivity gains, and the Company’s flexible labor model, which continues to support efficient fulfillment operations while enabling targeted investments in infrastructure, technology, and automation to support future growth.
Balance Sheet and Liquidity Strength: The Company ended the quarter with working capital of approximately $60.0 million, reflecting disciplined management of inventory and payables to support ongoing growth. The Company had approximately $56 million of availability under its revolving credit facility at quarter end, providing ample liquidity and financial flexibility to support working capital needs and strategic initiatives.
“Our third quarter results reflect continued strength across our core categories and the operating leverage inherent in our model,” said Jeff Walker, Chief Executive Officer of Alliance Entertainment. “We delivered over 21% revenue growth in the quarter and strong year-to-date earnings expansion, demonstrating that our platform is scaling and that improvements in product mix and cost structure are translating into durable profitability.”
“We are also seeing continued validation of the broader shift toward physical media as a collectible category, where ownership, scarcity, and premium formats are driving collector purchasing behavior,” Walker added. “This trend is increasingly supported by collector-driven discovery and community engagement across social media platforms, particularly among younger consumers who are prioritizing intentional listening, tangible ownership, and long-term value. Our exclusive partnerships and curated assortment position us at the center of that trend, while our direct-to-consumer and platform initiatives are enabling us to capture more value across the lifecycle of each product.”
“During the quarter, we advanced the next phase of our strategy with the launch of Alliance Authentic™, extending our platform into authenticated collectibles,” Walker continued. “Importantly, this represents the first commercial application of Endstate Authentic, our NFC-enabled authentication platform, and extends our role beyond distribution into ownership, provenance, and the full lifecycle of collectible products. Subsequent to quarter end, we further expanded our platform strategy with the relaunch of Movies Unlimited as a curated, collector-focused destination designed to deepen engagement and increase customer lifetime value. Together, these initiatives build on our existing scale to enhance product value, strengthen customer relationships, and create additional long-term growth opportunities.”
Amanda Gnecco, Chief Financial Officer of Alliance Entertainment, said, “We delivered strong financial performance in the third quarter, with revenue up 21% and net income increasing 25% year-over-year. For the first nine months of fiscal year 2026, net income increased 78% to $16.6 million, and Adjusted EBITDA increased 47% to $35.7 million, highlighting the growing earnings power and scalability of our platform.”
“We are seeing clear operating leverage across the business, with operating expenses declining as a percentage of revenue even as we continue to invest in infrastructure, technology, and growth initiatives. At the same time, we maintained a strong liquidity position, ending the quarter with approximately $60 million in working capital and $56 million of availability under our revolving credit facility. With a more efficient cost structure and continued momentum in higher-value categories, we believe we are well positioned to sustain both revenue growth and meaningful earnings expansion.”
Third Quarter FY 2026 Financial Results
Net revenues for the fiscal third quarter ended March 31, 2026, were $258.2 million, up 21.1% from $213 million in the same period of fiscal 2025.
Gross profit for the fiscal third quarter ended March 31, 2026, was $33.0 million, up 13.4% from $29.1 million in the same period of fiscal 2025.
Gross margin for the fiscal third quarter ended March 31, 2026, was 12.8%, compared to 13.6% in the same period of fiscal 2025.
Net income for the fiscal third quarter ended March 31, 2026, was $2.3 million, or $0.05 per diluted share, up 25.0% from net income of $1.9 million, or $0.04 per diluted share for the same period of fiscal 2025.
Adjusted EBITDA for the fiscal third quarter ended March 31, 2026, was $5.1 million, up 4.1% from Adjusted EBITDA of $4.9 million for the same period of fiscal 2025.
Nine-Months FY 2026 Financial Results
Net revenues for the nine months ended March 31, 2026, were $880.9 million, up 5.0% from $835.7 million in the same period of fiscal 2025.
Gross profit for the nine months ended March 31, 2026, was $117.3 million, up 21.0% from $96.9 million in the same period of fiscal 2025.
Gross margin for the nine months ended March 31, 2026, was 13.3%, up 170 basis points from 11.6% in the same period of fiscal 2025.
Net income for the nine months ended March 31, 2026, was $16.6 million, or $0.32 per diluted share, up 78% from net income of $9.3 million, or $0.18 per diluted share for the same period of fiscal 2025.
Adjusted EBITDA for the nine months ended March 31, 2026, was $35.7 million, up 47% from Adjusted EBITDA of $24.4 million for the same period of fiscal 2025.
Conference Call
Alliance Entertainment Chief Executive Officer Jeff Walker, Chief Financial Officer Amanda Gnecco, and Executive Chairman Bruce Ogilvie will host the conference call, which will be followed by a question-and-answer session. A presentation will accompany the call and can be viewed during the webcast or accessed via the investor relations section of the Company’s website here.
To access the call, please use the following information:
Date:
Thursday, May 12, 2026
Time:
4:30 p.m. Eastern Time, 1:30 p.m. Pacific Time
Toll-free dial-in number:
1-877-407-0784
International dial-in number:
1-201-689-8560
Conference ID:
13760161
Please call the conference telephone number 5-10 minutes prior to the start time. An operator will register your name and organization. If you have any difficulty connecting with the conference call, please contact RedChip Companies at 1-407-644-4256.
A telephone replay of the call will be available approximately three hours after the call concludes and can be accessed through June 14, 2026, using the following information:
Toll-free replay number:
1-844-512-2921
International replay number:
1-412-317-6671
Replay ID:
13760161
About Alliance Entertainment
Alliance Entertainment (NASDAQ: AENT) is a premier distributor and fulfillment partner for the entertainment and pop culture collectibles industry. With more than 340,000 unique in-stock SKUs – including over 57,300 exclusive titles across compact discs, vinyl LPs, DVDs, Blu-rays, and video games – Alliance offers the largest selection of physical media in the market. Our vast catalog also includes licensed merchandise, toys, retro gaming products, and collectibles, serving over 35,000 retail locations and powering e-commerce fulfillment for leading retailers. Alliance also owns and operates proprietary collectibles brands, including Handmade by Robots™, a stylized vinyl figure line featuring licensed characters from leading entertainment franchises, and Alliance Authentic™, a premium platform for authentic, certified, and individually numbered entertainment collectibles. In addition, Alliance operates Endstate Authentic, a dedicated NFC-enabled authentication and digital product identity platform supporting authenticated collectibles, resale, and brand protection. Leveraging decades of operational expertise, exclusive sourcing relationships, and a capital-light, scalable infrastructure, Alliance connects fans and collectors to the products, franchises, and experiences they value across formats and generations. For more information, visit www.aent.com.
Forward Looking Statements
Certain statements included in this Press Release that are not historical facts are forward-looking statements for purposes of the safe harbor provisions under the United States Private Securities Litigation Reform Act of 1995. Forward-looking statements generally are accompanied by words such as “believe,” “may,” “will,” “estimate,” “continue,” “anticipate,” “intend,” “expect,” “should,” “would,” “plan,” “predict,” “potential,” “seem,” “seek,” “future,” “outlook,” and similar expressions that predict or indicate future events or trends or that are not statements of historical matters. These forward-looking statements include, but are not limited to, statements regarding estimates and forecasts of other financial and performance metrics and projections of market opportunity. These statements are based on various assumptions, whether identified in this Press Release, and on the current expectations of Alliance’s management and are not predictions of actual performance. These forward-looking statements are provided for illustrative purposes only and are not intended to serve as and must not be relied on by an investor as, a guarantee, an assurance, a prediction, or a definitive statement of fact or probability. Actual events and circumstances are difficult or impossible to predict and will differ from assumptions. Many actual events and circumstances are beyond the control of Alliance. These forward-looking statements are subject to a number of risks and uncertainties, including risks relating to the anticipated growth rates and market opportunities; changes in applicable laws or regulations; the ability of Alliance to execute its business model, including market acceptance of its systems and related services; Alliance’s reliance on a concentration of suppliers for its products and services; increases in Alliance’s costs, disruption of supply, or shortage of products and materials; Alliance’s dependence on a concentration of customers, and failure to add new customers or expand sales to Alliance’s existing customers; increased Alliance inventory and risk of obsolescence; Alliance’s significant amount of indebtedness; our ability to refinance our existing indebtedness; our ability to continue as a going concern absent access to sources of liquidity; risks that a breach of the revolving credit facility could result in the lender declaring a default and that the full outstanding amount under the revolving credit facility could be immediately due in full, which would have severe adverse consequences for the Company; known or future litigation and regulatory enforcement risks, including the diversion of time and attention and the additional costs and demands on Alliance’s resources; Alliance’s business being adversely affected by increased inflation, uncertainty regarding tariffs, higher interest rates and other adverse economic, business, and/or competitive factors; geopolitical risk and changes in applicable laws or regulations; as well as our financial condition and results of operations; substantial regulations, which are evolving, and unfavorable changes or failure by Alliance to comply with these regulations; product liability claims, which could harm Alliance’s financial condition and liquidity if Alliance is not able to successfully defend or insure against such claims; availability of additional capital to support business growth; and the inability of Alliance to develop and maintain effective internal controls.
For investor inquiries, please contact:
Dave Gentry RedChip Companies, Inc. 1-800-REDCHIP (733-2447) 1-407-644-4256 [email protected]
CULVER CITY, Calif., May 14, 2026 (GLOBE NEWSWIRE) — Snail, Inc. (Nasdaq: SNAL) (“Snail Games” or the “Company”), a leading global independent developer and publisher of interactive digital entertainment, recently attended Gamescom LATAM, reinforcing its long-term commitment to expanding operations, partnerships, and publishing opportunities across Latin America. The event, which continues to grow in global relevance, saw attendance increase by 17.5% in 2026, highlighting the region’s accelerating importance within the international games industry.
Latin America remains one of the fastest-growing interactive entertainment markets worldwide, with Brazil at its center. Brazil alone represents the largest games market in the region and the fifth largest globally by online population, with an estimated 103 million players. According to the Game Brasil Survey, 82.1% of Brazilians identify video games as one of their primary forms of entertainment, highlighting a deeply engaged and highly active user base.
Snail Games USA is actively deepening its engagement across LATAM as part of a broader global publishing strategy. The Company continues to expand its footprint across key gaming regions, with headquarters in the United States, an established development presence in Europe through its recent acquisition of Donkey Crew (developers of Bellwright), and a growing operational and publishing network across Asia. This multi-region foundation is now extending into Latin America, where the Company is actively exploring new indie publishing opportunities, strategic partnerships, and co-development pipelines aimed at strengthening its position within a highly engaged gaming market and further diversifying its gaming portfolio.
The Company continues to see strong support from LATAM across its overall existing portfolio, led by sustained engagement in its flagship franchise ARK. ARK: Survival Ascended sold approximately 1.4 million units, while ARK: Survival Evolved sold over 570,000 units in Q1 2026, reflecting global continued demand for the franchise across both legacy and next-generation audiences. Highlighting the region’s importance within Snail Games USA’s flagship franchise, ARK: Ultimate Mobile Edition achieved 11.9 million downloads as of March 31, 2026, with Brazil being #2 in the active territories for Google Play, #2 in Gross Revenue, and #1 in total downloads for Google Play.
By deepening its presence in Brazil and the broader Latin American market, Snail Games USA is positioning itself to participate in one of the most dynamic and rapidly expanding regions in global gaming. Following the Company’s partnership last year with Latin American indie development team Four Leaf Clover, Snail Games USA continues to push forward cultivating regional development relationships, discovering emerging indie titles, and strengthening its long-term publishing pipeline across the global market.
For creators interested in collaborations please reach out to [email protected]
About Snail, Inc. Snail, Inc. (Nasdaq: SNAL) is a leading global independent developer and publisher of interactive digital entertainment for consumers around the world, with a premier portfolio of premium games designed for use on a variety of platforms, including consoles, PCs, and mobile devices. For more information, please visit: https://snail.com/
Forward-Looking Statements:
This press release contains statements that constitute forward-looking statements. Many of the forward-looking statements contained in this press release can be identified by the use of forward-looking words such as “anticipate,” “believe,” “could,” “expect,” “should,” “plan,” “intend,” “may,” “predict,” “continue,” “estimate” and “potential,” or the negative of these terms or other similar expressions. Forward-looking statements appear in a number of places in this press release and include, but are not limited to, statements regarding Snail’s intent, belief or current expectations. These forward-looking statements include information about possible or assumed future results of Snail’s business, financial condition, results of operations, liquidity, plans and objectives. The statements Snail makes regarding the following matters are forward-looking by their nature: the Company expanding operations, partnerships, and publishing opportunities across Latin America; Gamescom LATAM continuing to grow in global relevance; the company continuing to expand its footprint across key gaming regions, with headquarters in the United States, an established development presence in Europe through its recent acquisition of Donkey Crew (developers of Bellwright), and a growing operational and publishing network across Asia; the Company continuing to see strong support from LATAM across its existing portfolio, led by sustained engagement in its flagship franchise, ARK; Snail Games USA positioning itself to participate in one of the most dynamic and rapidly expanding regions in global gaming; and Snail Games USA continuing to push forward cultivating regional development relationships, discovering emerging indie titles, and strengthening its long term publishing pipeline across the global market.
Any forward-looking statements included herein reflect Snail’s current views, and they involve certain risks and uncertainties, including, among others, Snail’s ability to continue to expand its footprint across key gaming regions including the United States, Europe, Asia and Latin America; acceptance of Snail’s titles in the marketplace and the successful development, marketing or sale of its titles and its ability to retain our key employees or maintain our Nasdaq listing. These risks should not be construed as exhaustive and should be read together with the other cautionary statement included in our Annual Report on Form 10-K for the year ended December 31, 2025, subsequent Quarterly Reports on Form 10-Q and current reports on Form 8-K filed with the Securities and Exchange Commission. Any forward-looking statement speaks only as of the date on which it was initially made. We undertake no obligation to publicly update or revise any forward-looking statement, whether as a result of new information, future events, changed circumstances or otherwise, unless required by law.
Investor Contact: John Yi and Steven Shinmachi Gateway Group, Inc. 949-574-3860 [email protected]
NEW YORK, May 14, 2026 (GLOBE NEWSWIRE) — Xcel Brands (NASDAQ: XELB), an industry leading media and consumer products company specializing in building influencer led brands through social commerce and live streaming, is excited to announce, Cesar Millan will be premiering with his new pet multi category collection Trust, Respect, Love by Cesar Millan on QVC (September, 2026).
Known worldwide for his training philosophy and decades of experience rehabilitating dogs and educating owners, Cesar Millan’s latest project will provide high quality and advanced products.
The Trust, Respect, Love by Cesar Millan collection will feature a curated assortment of pet essentials and lifestyle products created to enhance daily routines for both dogs and their owners. Inspired by Cesar Millan’s lifelong mission to educate and empower pet owners, the brand reflects a balanced approach to care, connection, and companionship.
“Cesar Millan is one of the most trusted names in the pet industry, and the Trust Respect Love by Cesar Millan brand perfectly captures the deep connection people have with their pets today,” said Robert D’Loren, Chairman and Chief Executive Officer. “This collection was designed to bring together style, function, and purpose through elevated pet products that reflect Cesar’s philosophy and resonate with today’s pet owners. We are thrilled to introduce this brand to QVC customers worldwide.”
“For me, trust, respect, and love are the foundations of every relationship with a dog,” said Cesar Millan. “This collection is about bringing those principles into everyday life with products that support both pets and the people who love them.”
About Cesar Millan Cesar Millan is a world-renowned dog behaviorist with over 25 years of experience transforming relationships between humans and their dogs. As the original host of the hit TV series, the Dog Whisperer, to his most recent Better Human, Better Dog, to his best-selling books and iconic workshops, Cesar has become a trusted guide for millions of dog lovers worldwide. With a social media following of over 21 million people and a legacy that spans two decades on television around the world, Cesar’s influence extends far and wide. Trusted by celebrities, world leaders, and first-time pet owners alike, Cesar is committed to helping you achieve lasting harmony with your dog. Cesar moves forward in his journey with purpose and you can follow this journey at www.cesarmillan.com.
Xcel Brands, Inc. (NASDAQ: XELB) is a media and consumer products company engaged in the design, licensing, marketing, live streaming, and social commerce sales of branded apparel, footwear, accessories, fine jewelry, home goods and other consumer products, and the acquisition of dynamic consumer lifestyle brands. Xcel was founded in 2011 with a vision to reimagine shopping, entertainment, and social media as social commerce. Xcel owns the Halston and C. Wonder brands, as well as the co-branded collaboration brands Tower Hill by Christie Brinkley, Trust. Respect. Love by Cesar Millan, GemmaMade by Gemma Stafford and Off/Duty by Coco Rocha brand and holds noncontrolling interests or long-term license agreement in Mesa Mia by Jenny Martinez. Xcel also owns and manages the Longaberger by Shannon Doherty brand through its controlling interest in Longaberger Licensing, LLC. Xcel is pioneering a modern consumer products sales strategy which includes the promotion and sale of products under its brands through interactive television, digital live-stream shopping, social commerce, brick-and-mortar retailers, and e-commerce channels to be everywhere its customer’s shop. The company’s previously owned and current brands have generated more than $5 billion in retail sales via livestreaming in interactive television and digital channels alone and has over 20,000 hours of content production time in live-stream and social commerce. The brand portfolio reaches more than 46 million social media followers with broadcast reaching 200 million households. Headquartered in New York City, Xcel Brands is led by an executive team with significant live streaming, production, merchandising, design, marketing, retailing, and licensing experience, and a proven track record of success in elevating branded consumer products companies. For more information, visit www.xcelbrands.com.
BERKELEY HEIGHTS, N.J., May 14, 2026 (GLOBE NEWSWIRE) — Tonix Pharmaceuticals Holding Corp. (Nasdaq: TNXP) (“Tonix” or the “Company”), a fully integrated, commercial biotechnology company, today announced a poster presentation at ISPOR 2026, the Professional Society for Health Economics and Outcomes Research’s annual meeting, being held May 17-20, 2026, in Philadelphia, Pennsylvania. The retrospective cohort study utilized U.S. claims data from April 2021-April 2024 to analyze adults with fibromyalgia. TONMYA® (cyclobenzaprine HCl sublingual tablets) was approved by the U.S. FDA on August 15, 2025, and commercially launched in the U.S. on November 17, 2025.
Poster Presentation Details
Title: Characterizing Patients with Fibromyalgia: A U.S. Real-World Claims Analysis Poster #: RWD167 Poster Session: 5 Date: Wednesday, May 20, 2026 Time: 9:00-11:30 a.m. ET Presenter: William Olsufka, PharmD, Tonix Medicines, Inc.
After the presentation, a copy of poster will be available under the Scientific Presentations tab on the Tonix website at https://www.tonixpharma.com/.
About Fibromyalgia Fibromyalgia is a chronic pain disorder that is understood to result from amplified sensory and pain signaling within the central nervous system. Fibromyalgia afflicts more than 10 million adults in the U.S., approximately 90% of whom are women. Symptoms of fibromyalgia include chronic widespread pain, nonrestorative sleep, fatigue, and morning stiffness. Other associated symptoms include cognitive dysfunction and mood disturbances, including anxiety and depression. Individuals suffering from fibromyalgia struggle with their daily activities, have impaired quality of life, and frequently are disabled. Physicians and patients report common dissatisfaction with currently marketed products.
About TONMYA® (cyclobenzaprine HCl sublingual tablets) TONMYA (cyclobenzaprine HCl sublingual tablets) is a patented sublingual tablet formulation of cyclobenzaprine hydrochloride which provides rapid transmucosal absorption and reduced production of a long half-life active metabolite, norcyclobenzaprine, due to bypass of first-pass hepatic metabolism. As a multifunctional agent with potent binding and antagonist activities at the 5-HT2A serotonergic, α1-adrenergic, H1-histaminergic, and M1-muscarinic receptors, TONMYA was approved on August 15, 2025, by the FDA for the treatment of fibromyalgia in adults. TONMYA is the first new prescription medicine approved for fibromyalgia in more than 15 years. TONMYA was investigated as TNX-102 SL. TNX-102 SL is also being developed to treat acute stress disorder (ASD)/acute stress reaction (ASR), and major depressive disorder (MDD). The United States Patent and Trademark Office (USPTO) issued United States Patent No. 9636408 in May 2017, Patent No. 9956188 in May 2018, Patent No. 10117936 in November 2018, Patent No. 10,357,465 in July 2019, and Patent No. 10736859 in August 2020. The Protectic™ protective eutectic and Angstro-Technology™ formulation claimed in the patent are important elements of Tonix’s proprietary TONMYA composition. These patents are expected to provide TONMYA with U.S. market exclusivity until 2034/2035.
Tonix Pharmaceuticals Holding Corp. Tonix Pharmaceuticals* is a fully integrated, commercial-stage biotechnology company focused on central nervous system (CNS) and immunology treatments in areas of high unmet medical need. TONMYA® (cyclobenzaprine HCl sublingual tablets 2.8 mg) is the first new treatment for fibromyalgia in adults in more than 15 years. Tonix’s CNS commercial infrastructure supports its marketed products, including its acute migraine products, Zembrace® Symtouch® (sumatriptan injection 3 mg) and Tosymra® (sumatriptan nasal spray 10 mg). Tonix is investigating TONMYA in Phase 2 clinical trials to evaluate its potential in major depressive disorder and acute stress disorder/acute stress reaction. Tonix is also advancing a pipeline of immunology programs, including TNX-4800, a Phase 2 ready long-acting human anti-Borrelia OspA monoclonal antibody (mAb) for the prevention of Lyme disease in the U.S., and TNX-1500, a Phase 2 ready third-generation CD154/CD40 ligand (CD40L) inhibitor for the prevention of kidney transplant rejection. In addition, Tonix is progressing TNX-2900 (intranasal potentiated oxytocin), which is Phase 2 ready for the treatment of Prader-Willi syndrome, a rare disease. To learn more, visit www.tonixpharma.com.
*Tonix’s product development candidates are investigational new drugs or biologics; their efficacy and safety have not been established and have not been approved for any indication.
Zembrace SymTouch and Tosymra are registered trademarks of Tonix Medicines. TONMYA is a registered trademark of Tonix Pharma Limited. All other marks are property of their respective owners.
Forward Looking Statements Certain statements in this press release are forward-looking within the meaning of the Private Securities Litigation Reform Act of 1995 including those relating to the completion of the offering, the satisfaction of customary closing conditions, the intended use of proceeds from the offering and other statements that are predictive in nature. These statements may be identified by the use of forward-looking words such as “anticipate,” “believe,” “forecast,” “estimate,” “expect,” and “intend,” among others. There are a number of factors that could cause actual events to differ materially from those indicated by such forward-looking statements. These factors include, but are not limited to, risks related to the failure to successfully launch and commercialize TONMYA® and any of our approved products; risks related to the failure to obtain FDA clearances or approvals and noncompliance with FDA regulations; risks related to the timing and progress of clinical development of our product candidates; our need for additional financing; uncertainties of patent protection and litigation; uncertainties of government or third party payor reimbursement; limited research and development efforts and dependence upon third parties; and substantial competition. As with any pharmaceutical under development, there are significant risks in the development, regulatory approval and commercialization of new products. Tonix does not undertake an obligation to update or revise any forward-looking statement. Investors should read the risk factors set in the Company’s Annual Report on Form 10-K for the year ended December 31, 2025, as filed with the SEC on March 12, 2026, and periodic reports filed with the SEC on or after the date thereof. Tonix does not undertake an obligation to update or revise any forward-looking statement. All of Tonix’s forward-looking statements are expressly qualified by all such risk factors and other cautionary statements. The information set forth herein speaks only as of the date thereof.
INDICATION TONMYA is indicated for the treatment of fibromyalgia in adults.
CONTRAINDICATIONS TONMYA is contraindicated:
In patients with hypersensitivity to cyclobenzaprine or any inactive ingredient in TONMYA. Hypersensitivity reactions may manifest as an anaphylactic reaction, urticaria, facial and/or tongue swelling, or pruritus. Discontinue TONMYA if a hypersensitivity reaction is suspected. With concomitant use of monoamine oxidase (MAO) inhibitors or within 14 days after discontinuation of an MAO inhibitor. Hyperpyretic crisis seizures and deaths have occurred in patients who received cyclobenzaprine (or structurally similar tricyclic antidepressants) concomitantly with MAO inhibitors drugs. During the acute recovery phase of myocardial infarction, and in patients with arrhythmias, heart block or conduction disturbances, or congestive heart failure. In patients with hyperthyroidism.
WARNINGS AND PRECAUTIONS Embryofetal toxicity: Based on animal data, TONMYA may cause neural tube defects when used two weeks prior to conception and during the first trimester of pregnancy. Advise females of reproductive potential of the potential risk and to use effective contraception during treatment and for two weeks after the final dose. Perform a pregnancy test prior to initiation of treatment with TONMYA to exclude use of TONMYA during the first trimester of pregnancy.
Serotonin syndrome: Concomitant use of TONMYA with selective serotonin reuptake inhibitors (SSRIs), serotonin norepinephrine reuptake inhibitors (SNRIs), tricyclic antidepressants, tramadol, bupropion, meperidine, verapamil, or MAO inhibitors increases the risk of serotonin syndrome, a potentially life-threatening condition. Serotonin syndrome symptoms may include mental status changes, autonomic instability, neuromuscular abnormalities, and/or gastrointestinal symptoms. Treatment with TONMYA and any concomitant serotonergic agent should be discontinued immediately if serotonin syndrome symptoms occur and supportive symptomatic treatment should be initiated. If concomitant treatment with TONMYA and other serotonergic drugs is clinically warranted, careful observation is advised, particularly during treatment initiation or dosage increases.
Tricyclic antidepressant-like adverse reactions: Cyclobenzaprine is structurally related to TCAs. TCAs have been reported to produce arrhythmias, sinus tachycardia, prolongation of the conduction time leading to myocardial infarction and stroke. If clinically significant central nervous system (CNS) symptoms develop, consider discontinuation of TONMYA. Caution should be used when TCAs are given to patients with a history of seizure disorder, because TCAs may lower the seizure threshold. Patients with a history of seizures should be monitored during TCA use to identify recurrence of seizures or an increase in the frequency of seizures. Atropine-like effects: Use with caution in patients with a history of urinary retention, angle-closure glaucoma, increased intraocular pressure, and in patients taking anticholinergic drugs.
CNS depression and risk of operating a motor vehicle or hazardous machinery: TONMYA monotherapy may cause CNS depression. Concomitant use of TONMYA with alcohol, barbiturates, or other CNS depressants may increase the risk of CNS depression. Advise patients not to operate a motor vehicle or dangerous machinery until they are reasonably certain that TONMYA therapy will not adversely affect their ability to engage in such activities. Oral mucosal adverse reactions: In clinical studies with TONMYA, oral mucosal adverse reactions occurred more frequently in patients treated with TONMYA compared to placebo. Advise patients to moisten the mouth with sips of water before administration of TONMYA to reduce the risk of oral sensory changes (hypoesthesia). Consider discontinuation of TONMYA if severe reactions occur.
ADVERSE REACTIONS The most common adverse reactions (incidence ≥2% and at a higher incidence in TONMYA-treated patients compared to placebo-treated patients) were oral hypoesthesia, oral discomfort, abnormal product taste, somnolence, oral paresthesia, oral pain, fatigue, dry mouth, and aphthous ulcer.
DRUG INTERACTIONS MAO inhibitors: Life-threatening interactions may occur. Other serotonergic drugs: Serotonin syndrome has been reported. CNS depressants: CNS depressant effects of alcohol, barbiturates, and other CNS depressants may be enhanced. Tramadol: Seizure risk may be enhanced. Guanethidine or other similar acting drugs: The antihypertensive action of these drugs may be blocked.
USE IN SPECIFIC POPULATIONS Pregnancy: Based on animal data, TONMYA may cause fetal harm when administered to a pregnant woman. The limited amount of available observational data on oral cyclobenzaprine use in pregnancy is of insufficient quality to inform a TONMYA-associated risk of major birth defects, miscarriage, or adverse maternal or fetal outcomes. Advise pregnant women about the potential risk to the fetus with maternal exposure to TONMYA and to avoid use of TONMYA two weeks prior to conception and through the first trimester of pregnancy. Report pregnancies to the Tonix Medicines, Inc., adverse-event reporting line at 1-888-869-7633 (1-888-TNXPMED). Lactation: A small number of published cases report the transfer of cyclobenzaprine into human milk in low amounts, but these data cannot be confirmed. There are no data on the effects of cyclobenzaprine on a breastfed infant, or the effects on milk production. The developmental and health benefits of breastfeeding should be considered along with the mother’s clinical need for TONMYA and any potential adverse effects on the breastfed child from TONMYA or from the underlying maternal condition.
Pediatric use: The safety and effectiveness of TONMYA have not been established. Geriatric patients: Of the total number of TONMYA-treated patients in the clinical trials in adult patients with fibromyalgia, none were 65 years of age and older. Clinical trials of TONMYA did not include sufficient numbers of patients 65 years of age and older to determine whether they respond differently from younger adult patients. Hepatic impairment: The recommended dosage of TONMYA in patients with mild hepatic impairment (HI) (Child Pugh A) is 2.8 mg once daily at bedtime, lower than the recommended dosage in patients with normal hepatic function. The use of TONMYA is not recommended in patients with moderate HI (Child Pugh B) or severe HI (Child Pugh C). Cyclobenzaprine exposure (AUC) was increased in patients with mild HI and moderate HI compared to subjects with normal hepatic function, which may increase the risk of TONMYA-associated adverse reactions.
Please see additional safety information in the full Prescribing Information. To report suspected adverse reactions, contact Tonix Medicines, Inc. at 1-888-869-7633, or the FDA at 1-800-FDA-1088 or www.fda.gov/medwatch.
CULVER CITY, Calif., May 13, 2026 (GLOBE NEWSWIRE) — Snail, Inc. (Nasdaq: SNAL) (“Snail Games” or the “Company”), a leading global independent developer and publisher of interactive digital entertainment, today announced financial results for the first quarter ended March 31, 2026.
First Quarter 2026 and Recent Operational Highlights
ARK Franchise Updates:
ARK: Survival Evolved (“ASE”):
Units sold were approximately 573,000 for the first quarter of 2026
During the first quarter of 2026, average daily active users (“DAU”) was 117,000 and peak DAU was 143,000
ARK: Survival Ascended (“ASA”):
Units sold were approximately 1.4 million for the first quarter of 2026
During the first quarter of 2026, average DAU was 127,000 and peak DAU was 188,000
ARK: Ultimate Mobile Edition (“ARK Mobile”):
11.9 million downloads as of March 31, 2026
During the first quarter of 2026, average DAU was 141,000
Game Portfolio and Business Updates:
For The Stars
Released new developer diary, offering an in-depth look at the upcoming AAA title’s current development progress, including new pre-alpha footage and previously unreleased concept art
Revealed event-exclusive trailer during 2026 Games Developers Conference (“GDC”)
Introduced PixARK Worlds, a new title in development that features revolutionary user-generated content designed to further expand the ARK universe on Steam, Xbox, PlayStation, and the Nintendo Switch 2
Bellwright
Surpassed 1 million downloads on Steam Early Access, announced console port plans to Xbox and PlayStation, and launched the Maiden Voyage update.
Launched Echoes of Elysium on Steam Early Access in partnership with Loric Games
Launched Survivor Merc’s 1.0 version across Steam, Xbox, and PlayStation
Launched Above the Snow on Steam
Announced publishing agreement for co-op party action title Dead Party
Unveiled new upcoming indie title, Gobby Gang, at 2026 GDC
As of March 31, 2026, SaltyTV released 250+ short film dramas
ARK Content Pipeline
Management Commentary
“We exited 2025 with tailwinds that positioned Snail for stronger and more stable growth and results,” said Company CEO Hai Shi. “Momentum from the ASA pipeline we announced in December, the launch of ARK Lost Colony DLC, and the subsequent Steam Winter Sale event supported net revenue growth and a return to net income positive. Looking ahead, we aim to deliver year-over-year growth in Q2, driven by several upcoming ARK content releases. We have a Fantastic Tames Season 1 Expansion Pack coming in May 2026, and ARK Tides of Fortune to launch alongside the remake of Genesis Part 1 coming to ASA in June 2026 to provide a foundation for the quarter to build on. Approximately $11 million from our deferred revenue backlog is expected to be recognized upon the release of Genesis Part 1.
“Beyond ARK, Snail Games continues to execute on its strategy to eventually become a fully integrated game developer and publisher. Our upcoming AAA titles represent an important step toward building new franchises with the potential for multi-year to multi-decade game lifespans that can complement the scale of ASE and ASA. As previously disclosed, these projects have entered their final phases of development, and the eventual launch of these games position us to meaningfully diversify our revenue mix beyond ARK. With multiple gaming events and planned updates throughout the year, we look forward to sharing additional information on For the Stars, Nine Yin Sutra: Immortal, and Nine Yin Sutra: Wushu.
“The next 12-18 months will serve as an inflection period for Snail Games as we work to advance our ARK pipeline and deliver on the investments we have made across our broader pipeline. Over time, our ambition is for Snail Games to be recognized not only for ARK, but as a developer and publisher of multiple renown IPs and titles. We remain focused on unlocking the value of our pipeline and delivering results.”
First Quarter 2026 Financial Highlights
Net revenues increased 35.7% to $27.3 million compared to $20.1 million in the same period last year. The increase was primarily due to an increase of $4.2 million and $2.1 million in revenue related to ASA and Bellwright, respectively, and a $2.5 million increase in deferred revenue recognized during the period, offset by a decrease in revenue from ARK Mobile and ASE of $1.6 million.
Total units sold increased 42.6% to 2.2 million units compared to 1.5 million units in the same period last year, primarily driven by an increase in sales of ARK franchise IPs of 0.5 million units and Bellwright of 0.2 million units.
Net income increased 210% to $2.1 million compared to a net loss of $1.9 million in the same period last year. The increase was primarily due to an increase in net revenue of $7.2 million and a decrease in total operating expenses of $0.3 million partially offset by an increase in provision for income taxes of $1.6 million, an increase in cost of revenues of $1.4 million and a decrease in total other income, net of $0.5 million.
Bookings increased 21.1% to $26.9 million compared to $22.2 million in the same period last year. The increase was primarily due to better sales promotions in 2026 compared to 2025, tailwind momentum from the December 2025 ARK: Lost Colony DLC release, and Bellwright’s highly regarded content update in late 2025.
EBITDA increased 173.3% to $2.4 million compared to $(3.2) million in the same period last year. The increase was primarily due to an increase in net income of $4.1 million and a decrease in the benefit from income taxes of $1.6 million.
As of December 31, 2025, unrestricted cash was $14.3 million compared to $8.6 million as of December 31, 2025.
Use of Non-GAAP Financial Measures
In addition to the financial results determined in accordance with U.S. generally accepted accounting principles, or GAAP, Snail believes Bookings and EBITDA, as non-GAAP measures, are useful in evaluating its operating performance. Bookings and EBITDA are non-GAAP financial measures that are presented as supplemental disclosures and should not be construed as alternatives to net income (loss) or revenue as indicators of operating performance, nor as alternatives to cash flow provided by operating activities as measures of liquidity, both as determined in accordance with GAAP. Snail supplementally presents Bookings and EBITDA because they are key operating measures used by management to assess financial performance. Bookings adjusts for the impact of deferrals and, Snail believes, provides a useful indicator of sales in a given period. Management believes Bookings and EBITDA are useful to investors and analysts in highlighting trends in Snail’s operating performance, while other measures can differ significantly depending on long-term strategic decisions regarding capital structure, the tax jurisdictions in which Snail operates and capital investments.
Bookings is defined as the net amount of products and services sold digitally or physically in the period. Bookings is equal to revenues, excluding the impact from deferrals. Below is a reconciliation of total net revenue to Bookings, the closest GAAP financial measure.
Webcast Details
The Company will host a webcast at 4:30 PM ET today to discuss its first quarter 2026 financial and operational results. Participants may access the live webcast and replay via the link here or on the Company’s investor relations website at https://investor.snail.com/.
About Snail, Inc.
Snail, Inc. (Nasdaq: SNAL) is a leading, global independent developer and publisher of interactive digital entertainment for consumers around the world, with a premier portfolio of premium games designed for use on a variety of platforms, including consoles, PCs, and mobile devices. For more information, please visit: https://snail.com/.
Forward-Looking Statements
This press release contains statements that constitute forward-looking statements. Many of the forward-looking statements contained in this press release can be identified by the use of forward-looking words such as “anticipate,” “believe,” “could,” “expect,” “should,” “plan,” “intend,” “may,” “predict,” “continue,” “estimate” and “potential,” or the negative of these terms or other similar expressions. Forward-looking statements appear in a number of places in this press release and include, but are not limited to, statements regarding Snail’s intent, belief or current expectations. These forward-looking statements include information about possible or assumed future results of Snail’s business, financial condition, results of operations, liquidity, plans and objectives. The statements Snail makes regarding the following matters are forward-looking by their nature: exiting 2025 with tailwinds that position the Company for stronger and more stable growth and results; delivering year-over-year growth in Q2 driven by several upcoming ARK content releases; releasing Fantastic Tames Season 1 Expansion Pack in May 2026 and ARK Tides of Fortune alongside the remake of Genesis Part 1 coming to ASA in June 2026 providing a foundation for the quarter to build on; recognizing approximately $11 million of deferred revenue backlog upon the release of Genesis Part 1; continuing to execute on the Company’s strategy to become a fully integrated game developer and publisher; the upcoming AAA titles representing an important step toward building new franchises with the potential for multi-year to multi-decade game lifespans that can complement the scale of ASE and ASA; the eventual launch of the upcoming games positioning the Company to meaningfully diversify our revenue mix beyond ARK; sharing additional information on For the Stars, Nine Yin Sutra: Immortal, and Nine Yin Sutra: Wushu; the next 12-18 months being an inflection period for the Company as it advances its ARK pipeline and delivers on the investments it has have made across its broader pipeline; the Company being recognized not only for ARK, but as a developer and publisher of multiple renown IPs and titles; and remaining focused on unlocking the value of the Company pipeline and delivering results.
Any forward-looking statements included herein reflect our current views, and they involve certain risks and uncertainties, including, among others, acceptance of our titles in the marketplace and the successful development, marketing or sale of our titles and our ability to retain our key employees or maintain our Nasdaq listing. These risks should not be construed as exhaustive and should be read together with the other cautionary statement included in our Annual Report on Form 10-K for the year ended December 31, 2025, subsequent Quarterly Reports on Form 10-Q and current reports on Form 8-K filed with the Securities and Exchange Commission. Any forward-looking statement speaks only as of the date on which it was initially made. We undertake no obligation to publicly update or revise any forward-looking statement, whether as a result of new information, future events, changed circumstances or otherwise, unless required by law.
Investor Contact:
John Yi and Steven Shinmachi Gateway Group, Inc. 949-574-3860 [email protected]
100% insulin independence achieved in 10 patients with type 1 diabetes treated with tegoprubart following islet transplantation in UChicago Medicine-led study
FDA Orphan Drug designation granted to tegoprubart for the prevention of allograft rejection in liver transplantation
Cash, cash equivalents and short-term investments totaled $111.1 million as of March 31, 2026
IRVINE, Calif., May 13, 2026 (GLOBE NEWSWIRE) — Eledon Pharmaceuticals, Inc. (“Eledon”) (Nasdaq: ELDN) today reported its first quarter 2026 operating and financial results and provided recent business highlights.
“In the first quarter of 2026, we achieved significant milestones in our tegoprubart program, including important data updates in kidney and islet cell transplantation and FDA Orphan Drug designation for tegoprubart in liver transplantation,” said David-Alexandre C. Gros, M.D., Chief Executive Officer of Eledon. “Looking ahead, we expect multiple catalysts in 2026, including regulatory engagements supporting the advancement of tegoprubart into Phase 3 development in kidney transplantation and discussions regarding a potential path to market in islet cell transplantation. We also plan to initiate several new clinical trials, including an investigator sponsored study in liver transplantation, and share new kidney transplant data from our Phase 2 BESTOW long-term extension study, building on encouraging 24-month Phase 1b results that demonstrated a durable safety profile and improved graft function.”
First Quarter 2026 Business Highlights
In March 2026, announced updated results from an ongoing investigator-led trial at the University of Chicago Medicine Transplant Institute evaluating tegoprubart in 12 adults with high-risk type 1 diabetes undergoing allogenic islet transplantation. All 10 patients who are more than four weeks post-transplant achieved 100% insulin independence. There were no signs of graft rejection or de novo donor-specific HLA antibodies and no evidence of nephrotoxicity, hypertension, or neurotoxicity, which are commonly associated with tacrolimus-based immunosuppression regimens, the current standard of care.
The U.S. Food and Drug Administration (FDA) granted Orphan Drug designation to tegoprubart for the prevention of allograft rejection in liver transplantation.
Presented 24-month follow-up data from eight patients enrolled in the Phase 1b trial long-term extension trial evaluating tegoprubart in kidney transplantation at the American Society of Transplant Surgeons Winter Symposium in January 2026. Results showed there were no episodes of biopsy-proven acute rejection, graft loss, death, new-onset diabetes mellitus, or de novo donor-specific antibody formation during the study period. Mean estimated glomerular filtration rate (eGFR) increased over the measurement period, from 67.0 mL/min/1.73 m2 at 12 months to 74.2 mL/min/1.73 m2 at 24 months.
2026 Anticipated Upcoming Milestones
Receive FDA guidance on the Phase 3 trial design assessing tegoprubart in kidney transplantation, followed by initiation of the Phase 3 trial pending regulatory alignment.
Report long-term data from Phase 1b and Phase 2 BESTOW studies evaluating tegoprubart in kidney transplantation.
Receive FDA regulatory guidance on the path to market for tegoprubart in islet cell transplantation and xenotransplantation.
Initiate an investigator-led study evaluating tegoprubart for the prevention of organ rejection in patients with renal dysfunction receiving an islet cell transplant.
Initiate an investigator-led study evaluating tegoprubart for the prevention of organ rejection in patients receiving a de novo liver transplant.
Initiate an investigator-led study evaluating tegoprubart for kidney transplant tolerance induction.
First Quarter 2026 Financial Results
Cash, cash equivalents and short-term investments totaled $111.1 million as of March 31, 2026, compared to $133.3 million as of December 31, 2025. The company expects current cash, cash equivalents and short-term investments to fund operations into 2Q 2027.
Research and development (R&D) expenses for the first quarter of 2026 were $17.2 million, including $1.1 million of non-cash stock-based compensation expense, compared to $13.5 million, including $1.0 million of non-cash stock-based compensation expense, for the comparable period in 2025.
General and administrative (G&A) expenses for the first quarter of 2026 were $4.0 million, including $1.1 million of non-cash stock-based compensation expense, compared to $4.4 million, including $1.8 million of non-cash stock-based compensation expense, for the comparable period in 2025.
Net loss for the first quarter of 2026 was $39.0 million, or $0.33 per basic common share, compared to a net loss of $6.5 million, or $0.08 per basic common share, for the comparable period in 2025. Net loss in the first quarter of 2026 included a non-cash loss of $19.0 million from changes in the fair value of warrant liabilities, while the 2025 net loss included a non-cash gain of $10.1 million from such changes. Excluding the non-cash items related to changes in the fair value of warrant liabilities, Eledon would have recorded a net loss of $20.1 million for the three months ended March 31, 2026, and $16.6 million for the three months ended March 31, 2025.
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-CD40 Ligand 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
Forward-Looking Statements
This press release contains forward-looking statements that involve substantial risks and uncertainties. Any statements about the company’s future expectations, plans and prospects, including statements about planned clinical trials, the development of product candidates, expected timing for initiation of future clinical trials, expected timing for receipt of data from clinical trials, the company’s capital resources and ability to finance planned clinical trials, as well as other statements containing the words “believes,” “anticipates,” “plans,” “expects,” “estimates,” “intends,” “predicts,” “projects,” “targets,” “looks forward,” “could,” “may,” and similar expressions, constitute forward-looking statements within the meaning of the Private Securities Litigation Reform Act of 1995. Forward-looking statements are inherently uncertain and are subject to numerous risks and uncertainties, including: our short operating history and shifts in our business strategy; our operating losses since inception; our need for additional funding to develop our lead drug candidate and our ability to secure additional funding on acceptable terms or at all; the impact of issuances of our common stock, including in the possibility of dilution or a decline in our stock price; our ability to successfully develop our product candidates; unfavorable global economic and financial market conditions; the regulatory environment of our business and our ability to obtain required regulatory approvals; results of non-clinical studies and clinical trials, and risks that non-clinical studies or early clinical trials may not be predictive of results of later-stage clinical trials; delays or difficulties in enrollment of patients in clinical trials; our ability to attract and retain our executives and key employees; legislation of the pharmaceutical and healthcare industries; cybersecurity and data privacy risks; the ability of our products to achieve marketing approval; competition in our industry; our ability to obtain
insurance coverage; our dependence on contract research organizations; our ability to protect our intellectual property; public health crises; our ability to maintain proper and effective internal control over financial reporting and other risks disclosed in our Annual Report on Form 10-K for the year ended December 31, 2025, filed with the Securities and Exchange Commission on March 19, 2026. Actual results may differ materially from those indicated by such forward-looking statements as a result of various factors. These risks and uncertainties, as well as other risks and uncertainties that could cause the company’s actual results to differ materially from the forward-looking statements contained herein, are discussed in our Annual 10-K, and other filings with the U.S. Securities and Exchange Commission, which can be found at www.sec.gov. Any forward-looking statements contained in this press release speak only as of the date hereof and not of any future date, and the company expressly disclaims any intent to update any forward-looking statements, whether as a result of new information, future events or otherwise.
Company Expands Strategic Immuno-Oncology Positioning Around Tumor Microenvironment Modulation, Checkpoint Enhancement, and Multi-Tumor Development Potential
ATLANTA, GA – May 13, 2026 – GeoVax Labs, Inc. (Nasdaq: GOVX), a clinical-stage biotechnology company developing immunotherapies and vaccines for solid tumors and infectious diseases, today highlighted the expanding strategic relevance of its Gedeptin® immuno-oncology program within the rapidly evolving landscape of combination immunotherapy and checkpoint inhibitor enhancement strategies.
GeoVax believes Gedeptin’s unique mechanism of localized tumor destruction combined with immune activation positions the program within a growing area of oncology focus: therapies designed to overcome immune resistance and enhance responsiveness to checkpoint inhibitors in immunologically “cold” tumors.
Checkpoint inhibitors targeting PD-1 and PD-L1 have transformed cancer treatment across multiple tumor types; however, many solid tumors remain insufficiently responsive due to immune-suppressive tumor microenvironments, inadequate immune-cell infiltration, and incomplete tumor antigen recognition. As a result, oncologists are increasingly focused on combination approaches capable of improving checkpoint inhibitor response rates and extending durability of benefit.
“Modern immuno-oncology is increasingly shifting toward combination strategies designed to improve the effectiveness of checkpoint inhibitors across broader patient populations,” said David Dodd, Chairman and Chief Executive Officer of GeoVax. “We believe Gedeptin aligns directly with this trend by functioning not simply as a localized tumor therapy, but as a potential immune-sensitization platform capable of enhancing anti-tumor immune responses in tumors where checkpoint inhibitors alone may be insufficient.”
Key characteristics of the Gedeptin platform include:
Tumor-agnostic mechanism of action independent of tumor histology or proliferation rate;
Strong bystander effect, allowing destruction of neighboring tumor cells even when only a fraction are directly transduced;
Tumor microenvironment remodeling and immune activation, potentially enhancing tumor recognition by the immune system;
Potential checkpoint sensitization, supporting combination strategies with PD-1 and PD-L1 inhibitors;
Compatibility with image-guided and intratumoral delivery approaches across multiple solid tumor settings.
GeoVax’s lead development focus for Gedeptin is a planned neoadjuvant combination study in recurrent head and neck squamous cell carcinoma (HNSCC), evaluating intratumoral Gedeptin together with PD-1 targeting immunotherapy in patients eligible for curative-intent surgery. The study is expected to evaluate pathologic response, immune biomarker modulation, and early event-free survival signals.
“The oncology field is increasingly recognizing that durable checkpoint inhibitor responses may require direct modulation of the tumor microenvironment in addition to checkpoint blockade alone,” continued Mr. Dodd. “We believe Gedeptin’s ability to induce localized tumor destruction while simultaneously promoting immune activation creates a compelling rationale for combination development approaches designed to broaden and deepen immunotherapy responses. Importantly, we believe this mechanism may ultimately extend beyond localized disease settings and support broader applicability across metastatic solid tumors where immune resistance remains a major therapeutic challenge.”
Beyond head and neck cancer, GeoVax believes Gedeptin may have broader applicability across solid tumors characterized by:
established checkpoint inhibitor treatment paradigms,
and at least one lesion amenable to intratumoral or image-guided delivery.
Potential future tumor targets under evaluation include melanoma, triple-negative breast cancer, cutaneous malignancies, and additional metastatic solid tumor settings.
“As the oncology landscape evolves beyond single-agent checkpoint inhibition toward increasingly sophisticated combination approaches, we believe therapies capable of enhancing immune recognition and overcoming tumor resistance mechanisms may become increasingly important,” added Mr. Dodd. “Our objective is to position Gedeptin within that emerging therapeutic landscape as a differentiated immune-enabling platform with potential applicability across multiple solid tumor indications.”
About Gedeptin®
Gedeptin® is GeoVax’s proprietary gene-directed enzyme prodrug therapy (GDEPT) platform under development for the treatment of solid tumors. The therapy is designed for intratumoral administration and utilizes a non-replicating adenoviral vector to deliver purine nucleoside phosphorylase (PNP) directly into tumor tissue. Following administration of fludarabine, the PNP enzyme converts the prodrug into a potent localized cytotoxic agent that destroys tumor cells while simultaneously generating immune-activating signals within the tumor microenvironment.
GeoVax is advancing development plans to evaluate Gedeptin in combination with immune checkpoint inhibitors, including pembrolizumab, with the goal of amplifying anti-tumor immune activation and broadening therapeutic applicability across multiple solid tumor indications.
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 second half 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’s broader pipeline includes the development of GEO-CM04S1, a next-generation COVID-19 vaccine candidate being evaluated in immunocompromised and other patient populations. 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.
TORONTO, May 13, 2026 /CNW/ – Power Metallic Mines Inc. (the “Company” or “Power Metallic”) (TSXV: PNPN) (OTCBB: PNPNF) (Frankfurt: IVV1) is pleased to announce an engagement with Vancouver-based Ideon Technologies (“Ideon”) to activate a borehole muon tomography imaging program at the Lion Zone discovery within the Nisk Polymetallic project area in Quebec, Canada. A global leader in subsurface intelligence, the Ideon REVEAL™ solution will generate a high-resolution, three-dimensional density model of the rock composition in and around the Lion deposit.
Figure 1 – Plan view of muon survey overlain Lion (CNW Group/Power Metallic Mines Inc.)Figure 2: Long section of muon survey overlain Lion (CNW Group/Power Metallic Mines Inc.)Figure 3 – An example of a density model showing alignment with historic drilling and illumination of new exploration targets, from a muon program conducted at Fireweed Metals’ Macmillan Pass District, Yukon Territory. https://ideon.ai/results/fireweed-metals-macpass/ (CNW Group/Power Metallic Mines Inc.)Figure 4: High-density iso-surfaces of BHP’s Nickel West from muon tomography data (blue) are identified within the survey region of interest. The joint inversion of airborne, ground gravity and muon tomography (green) is also shown. The main N-S trending structure is clearly aligned with a mafic intrusion, as described earlier. The massive sulphide structure to the East is seen in the muon tomography inversion, but is not apparent in the gravity inversions – though there is some slight density variation seen in the airborne data. The joint inversion is very compatible with the presence of the massive sulphide. https://ideon.ai/results/bhp-leinster-mine/ (CNW Group/Power Metallic Mines Inc.)
The program is structured in two stages: first, validating the Ideon density model against Power Metallic’s existing 100-plus hole drill dataset at Lion; then applying the calibrated mineralization fingerprint to rank and test deep targets across the 330 km² Nisk district scale property that are below the detection limit of conventional surface-based geophysical methods (i.e., below 200 m).
About the Technology: Seeing Deep into the Earth using Energy from Space
The Ideon REVEAL™ Platform detects cosmic-ray muons — naturally occurring subatomic particles created by supernova explosions in deep space. Muons lose energy progressively in direct proportion to the density of the material they pass through. By positioning arrays of muon detectors in boreholes at varying depths, Ideon can construct 3D tomographic models of subsurface density over millions of cubic metres of earth, potentially replacing hundreds of drillholes while providing greater subsurface visibility at a fraction of the cost and time, and with significantly less environmental impact.
The Ideon REVEAL™ Platform and is designed for the most demanding of exploration and mining environments. It uses proprietary hardware, software and imaging systems with advanced AI-powered analysis and data fusion capabilities. It has been field-proven at some of the world’s most demanding mine sites, including at Rio Tinto’s Kennecott Utah Copper operation at Bingham Canyon, BHP’s Nickel West and Olympic Dam mines in Australia, Vale Base Metals’ Creighton and Totten mines in Sudbury, Ontario, and Fireweed Metals’ remote Macmillan Pass District in the Yukon Territory.
Why Lion Is an Exceptional Muon Target
The mineralogy of the Lion Zone is ideally suited to muon tomography. The deposit’s high-grade core is dominated by massive to brecciated chalcopyrite, cubanite, pyrrhotite, pentlandite, and pyrite — minerals with bulk densities of 4.0 to 5.0+ g/cc. These contrast sharply with the surrounding felsic, mafic and ultramafic host rocks, which carry background densities of approximately 2.8 to 3.0 g/cc. The Ideon solution will be used to produce 3D density models of individual dipping stratigraphic horizons and potential extensions of the deposit at multi-metre scale resolution.
The initial phase of the program will deploy borehole muon detectors into dedicated drill holes at the Lion Zone. The imaging program will run autonomously, passively and continuously collecting data over several months and delivering to Power Metallic a three-dimensional density model of the deposit. This phase will be conducted blindly, meaning that no constraining data (other than surface topography) will be provided.
In total the survey will map the density of over 55,000,000 m3 of rock volume. The imaging program is planned to run for 6 months in duration, with the option to extend to 8 months if needed to optimize resolution and establish the Lion Zone ore signature.
The Lion imaging program is designed as a validation exercise. Power Metallic holds an extensive drill dataset at Lion built from more than 100 holes across multiple campaigns. By producing an unconstrained muon inversion and then comparing it directly against the known resource model, the Company will establish the geophysical fingerprint of a Lion-style polymetallic massive sulfide system. Once the density signature of Lion mineralization is confirmed to match the tomographic model, that calibrated signature will become the search template for the broader Nisk project district.
District Scale: Opening a New Search Space
The most transformative potential of this program lies beyond Lion itself.
Power Metallic’s Nisk project encompasses ~330 km² of land including approximately 20 km of strike on the northern basin margin and 30 km on the southern basin margin — a contiguous belt hosting the Nisk Main deposit, the Lion discovery, and numerous additional untested geophysical anomalies. To date, surface and near-surface exploration methods including airborne magnetics, ground gravity, and Airborne EM have provided effective screening tools for targets shallower than approximately 200 m depth. Below that threshold, surface-based techniques are unable to detect deposit-scale targets.
“One of the challenges in exploring any deposit is false positives. Borehole EM continues to be the gold standard, but increasingly we are looking to combine it with other techniques that can image thicker mineralization. We are excited to integrate our current best practice workflow with muon tomography, a technique that’s demonstrated it can discover thicker intersections of sulfides. By incorporating an additional physical property beyond BHEM, we aim to improve our probability of target success and better discriminate high-quality conductors. We are always striving to discover better ore, not just more ore.” commented Steve Beresford, Director.
Muon tomography will be used to target a search space below 200 meters. Ideon muon sensors can image key geological features in the deep subsurface extending the effective targeting depth range where the next Lion-scale discovery may be hiding.
The geological rationale for deep exploration at Nisk is compelling. The Tiger Zone, located approximately 700 m east of Lion, has already returned Lion-style polymetallic mineralization, confirming the mineralizing system is not confined to Lion alone. The 5.5-km corridor between Lion and Nisk Main remains largely untested at depth. Company geologists have interpreted an easterly plunging structural control on high-grade Lion mineralization that acts as a vector toward a potential source body at greater depth. Regional structural analysis has identified a fold-hinge zone on newly acquired ground that covers an extension of the Lion mineralizing system previously outside the property boundary.
Once a validated muon signature of Lion mineralization is in hand, Power Metallic intends to conduct phased muon surveys across priority targets within this district, applying the calibrated density fingerprint of its known deposit type to rank and test anomalies that otherwise would have to be evaluated with blind drilling.
Learn more about how muon tomography works at this link.
“We have been excited about Nisk’s geological potential for many years and of course with the amazing success of the Lion Zone Discovery we entered a new frontier. With the guidance of our technical director Steve Beresford and the Geovector team led by our VP of Exploration Joe Campbell we have continuously pushed the targeting envelope to discover thicker massive Cu-PGE sulfides. Historically we know the polymetallic discoveries around the world are some of the largest and most profitable mines ever discovered. These discoveries are an order of magnitude bigger than what we have currently discovered. Even the smallest polymetallic discovery is more than 50% larger. What that means in practical terms is we have probably only scratched the surface at Nisk. Even as we are planning to publish our inaugural MRE (Mineral Resource Estinate) this summer to demonstrate that the current discoveries have exciting commercial potential, we remain focused on uncovering Nisk’s full potential. Our team believes that muon tomography is the next tool that can accelerate our discovery process and everything I have seen makes me confident that they have once again chosen wisely.” commented Terry Lynch, CEO & Director.
Qualified Person
Joseph Campbell, P. Geo, VP Exploration at Power Metallic, is the qualified person who has reviewed and approved the technical disclosure contained in this news release.
About Power Metallic Mines Inc.
Power Metallic is a Canadian exploration company focused on advancing the Nisk Project Area (Nisk–Lion–Tiger)–a high–grade Copper–PGE, Nickel, gold and silver system–toward Canada’s next polymetallic mine.
On 1 February 2021, Power Metallic (then Chilean Metals) secured an option to earn up to 80% of the Nisk project from Critical Elements Lithium Corp. (TSX–V: CRE). Following the June 2025 purchase of 313 adjoining claims (~167 km²) from Li–FT Power, the Company now controls ~330 km² and roughly 50 km of prospective basin margins.
Power Metallic is expanding mineralization at the Nisk and Lion discovery zones, evaluating the Tiger target, and exploring the enlarged land package through successive drill programs. Beyond the Nisk Project Area, Power Metallic indirectly has an interest in significant land packages in British Columbia and Chile, by its 50% share ownership position in Chilean Metals Inc., which were spun out from Power Metallic via a plan of arrangement on February 3, 2025.
It also owns 100% of Power Metallic Arabia which owns 100% interest in the Jabul Baudan exploration license in The Kingdon of Saudi Arabia’s Jabal Said Belt. The property encompasses over 200 square kilometres in an area recognized for its high prospectivity for copper gold and zinc mineralization. The region is known for its massive volcanic sulfide (VMS) deposits, including the world-class Jabal Sayid mine and the promising Umm and Damad deposit.
For further information, readers are encouraged to contact: Power Metallic Mines Inc. The Canadian Venture Building 82 Richmond St East, Suite 202 Toronto, ON
Neither the TSX Venture Exchange nor its Regulation Services Provider accepts responsibility for the adequacy or accuracy of this release.
QAQC and Sampling GeoVector Management Inc (“GeoVector”) is the Consulting company retained to perform the actual drilling program, which includes core logging and sampling of the drill core.
All core in this news release is either HQ or NQ sized core. Drill core is re-fitted and measured. Geotech on core includes photographs (wet & dry), rock quality index, magnetic susceptibility, conductivity, and recovery estimates. Core is logged for lithology, mineralogy, and structural features, and sample intervals are delineated and tagged.
Sampled core is mechanically sawn, and half-core is retained for future reference. GeoVector’s QAQC program includes regular insertion of CRM standards, duplicates, and blanks into the sample stream with a stringent review of all results. QAQC and data validation was performed, and no material errors were observed.
All samples were submitted to and analyzed at Activation Laboratories Ltd (“Actlabs”), a commercial laboratory independent of Power Metallic with no interest in the Project. Actlabs is an ISO 9001 and 17025 certified and accredited laboratories. Samples submitted through Actlabs are run through standard preparation methods and analysed using RX-1 (Dry, crush (< 7 kg) up to 80% passing 2 mm, riffle split (250 g) and pulverize (mild steel) to 95% passing 105 μm) preparation methods, and using 1F2 (ICP-OES) and 1C-OES – 4-Acid near total digestion + Gold-Platinum-Palladium analysis and 8-Peroxide ICP-OES, for regular and over detection limit analysis. Pegmatite samples are analyzed using UT7 – Li up to 5%, Rb up to 2% method. Actlabs also undertake their own internal coarse and pulp duplicate analysis to ensure proper sample preparation and equipment calibration.
This message contains certain statements that may be deemed “forward-looking statements” concerning the Company within the meaning of applicable securities laws. Forward-looking statements are statements that are not historical facts and are generally, but not always, identified by the words “expects,” “plans,” “anticipates,” “believes,” “intends,” “estimates,” “projects,” “potential,” “indicates,” “opportunity,” “possible” and similar expressions, or that events or conditions “will,” “would,” “may,” “could” or “should” occur. Although the Company believes the expectations expressed in such forward-looking statements are based on reasonable assumptions, such statements are not guarantees of future performance, are subject to risks and uncertainties, and actual results or realities may differ materially from those in the forward-looking statements. Such material risks and uncertainties include, but are not limited to, among others; the timing for various drilling plans; the ability to raise sufficient capital to fund its obligations under its property agreements going forward and conduct drilling and exploration; to maintain its mineral tenures and concessions in good standing; to explore and develop its projects; changes in economic conditions or financial markets; the inherent hazards associates with mineral exploration and mining operations; future prices of nickel and other metals; changes in general economic conditions; accuracy of mineral resource and reserve estimates; the potential for new discoveries; the ability of the Company to obtain the necessary permits and consents required to explore, drill and develop the projects and if accepted, to obtain such licenses and approvals in a timely fashion relative to the Company’s plans and business objectives for the applicable project; the general ability of the Company to monetize its mineral resources; and changes in environmental and other laws or regulations that could have an impact on the Company’s operations, compliance with environmental laws and regulations, dependence on key management personnel and general competition in the mining industry.
SOURCE Power Metallic Mines Inc.
For further information on Power Metallic Mines Inc., please contact: Duncan Roy, VP Investor Relations, 416-580-3862, [email protected]
Net Income and Operating Income Reported for Third Consecutive Quarter Revenues, Net Income and Adjusted EBITDA Exceed High End of Guidance Tenth Consecutive Quarter of Positive Adjusted EBITDA
EL SEGUNDO, Calif.–(BUSINESS WIRE)– The Beachbody Company, Inc. (NASDAQ: BODi) (“BODi” or the “Company”), the proactive wellness company delivering nutrition, supplements, and proven fitness programs that help people take control of their health inside and out, today announced financial results for its first quarter ended March 31, 2026.
“Q1 marks our third consecutive quarter of profitability on both net income and operating income, validating the strength of our transformed business model,” said Carl Daikeler, co-founder and BODi’s Chief Executive Officer. “We’re now deploying this efficient platform to capitalize on a major market opportunity in nutrition, a massive global category that’s more than 12 times the size of digital fitness. With attractively priced supplements under iconic brands like P90X and Shakeology, we can acquire nutrition customers and seamlessly migrate them to our digital fitness platform, delivering the Total Solution that has always driven our best customer results.”
“Our strong balance sheet and substantially improved financial position provide the flexibility to fund our retail expansion and innovation pipeline,” said Mark Goldston, BODi’s Executive Chairman. “With ten consecutive quarters of positive Adjusted EBITDA and a dramatically lowered breakeven point that creates massive operating leverage, we’ve built a resilient financial foundation that positions us to capitalize on significant growth opportunities in both nutrition and digital fitness.”
First Quarter 2026 Results
Total revenue was $54.3 million compared to $72.4 million in the prior year period.
Digital revenue was $33.6 million compared to $42.9 million in the prior year period and digital subscriptions totaled 0.81 million in the first quarter.
Nutrition and Other revenue was $20.7 million compared to $28.7 million in the prior year period and nutritional subscriptions totaled 0.06 million in the first quarter.
Connected Fitness revenue was $0.0 million compared to $0.8 million in the prior year period as we ceased the sale of bike inventory in the first quarter of 2025.
Gross margin was 71.8% compared to 71.2% in the prior year period.
Total operating expenses were $35.9 million compared to $55.2 million in the prior year period.
Operating income improved by $6.8 million to $3.1 million, the Company’s third consecutive quarter of operating income, compared to an operating loss of $3.7 million in the prior year period.
Net income was $2.3 million, the Company’s third consecutive quarter of net income, compared to a net loss of $5.7 million in the prior year period.
Adjusted EBITDA 1 was $8.0 million compared to $3.7 million in the prior year period.
Adjusted net income 1 was $2.5 million compared to a loss of $5.1 million in the prior year period.
Cash used in operating activities for the three months ended March 31, 2026 was $1.0 million compared to cash provided by operating activities of $2.3 million in the prior year period, and cash used in investing activities was $0.7 million compared to cash used in investing activities of $0.7 million in the prior year period. Free cash flow 1 was $(1.7) million compared to $1.6 million in the prior year period.
1Definitions of (1) Adjusted EBITDA, (2) adjusted net income (loss), (3) free cash flow and (4) net cash position, and reconciliations to the comparable GAAP metrics, are at the end of this release.
Key Operational and Business Metrics
Outlook for The Second Quarter of 2026
Conference Call and Webcast Information
BODi will host a conference call at 5:00 pm ET on Tuesday, May 12, 2026, to discuss its financial results and matters other than past results, such as guidance. To participate in the live call, please dial (833) 461-5787 (U.S. & Canada) and provide the conference identification number: 684011158. The conference call will also be available to interested parties through a live webcast at https://investors.thebeachbodycompany.com/.
After the conference call, a webcast replay will remain available on the investor relations section of the Company’s website for one year.
About BODi and The Beachbody Company, Inc.
BODi is a proactive wellness company delivering nutrition, supplements, and proven fitness programs that help people take control of their health inside and out. With nearly three decades of experience, BODi, formerly Beachbody, has evolved from a leader in home fitness into a comprehensive health and fitness ecosystem designed to help people achieve their goals and lead healthier, more fulfilling lives. Anchored by science-backed nutrition solutions like Shakeology and supported by its portfolio of proven fitness and habit-building programs, including P90X and INSANITY, BODi is creating a more accessible and effective path to long-term health. Since its inception, BODi has supported more than 30 million customers in achieving lasting results. The company continues to innovate across nutrition and digital fitness to deliver simple, proven solutions for modern lifestyles. For more information, please visit TheBeachBodyCompany.com.
Safe Harbor Statement
This press release of The Beachbody Company, Inc. (“we,” “us,” “our,” and similar terms) 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, which are statements other than statements of historical facts and statements in future tense. These statements include but are not limited to, statements regarding our future performance and our market opportunity, including expected financial results for the second quarter and full year, our business strategy, our plans, and our objectives and future operations.
Forward-looking statements are based upon various estimates and assumptions, as well as information known to us as of the date hereof, and are subject to risks and uncertainties. Accordingly, actual results could differ materially due to a variety of factors, including: our ability to effectively compete in the fitness and nutrition industries; our ability to successfully acquire and integrate new operations; our reliance on a few key products; market conditions and global and economic factors beyond our control; intense competition and competitive pressures from other companies worldwide in the industries in which we operate; and litigation and the ability to adequately protect our intellectual property rights. You can identify these statements by the use of terminology such as “believe”, “plans”, “expect”, “will”, “should,” “could”, “estimate”, “anticipate” or similar forward-looking terms. You should not rely on these forward-looking statements as they involve risks and uncertainties that may cause actual results to vary materially from the forward-looking statements. For more information regarding the risks and uncertainties that could cause actual results to differ materially from those expressed or implied in these forward-looking statements, as well as risks relating to our business in general, we refer you to the “Risk Factors” section of our Securities and Exchange Commission (“SEC”) filings, including those risks and uncertainties included in the Form 10-K filed with the SEC on March 10, 2026 and any subsequent Quarterly Reports on Form 10-Q or Current Reports on Form 8-K, which are available on the Investor Relations page of our website at https://investors.thebeachbodycompany.com and on the SEC’s website at www.sec.gov.
All forward-looking statements contained herein are based on information available to us as of the date hereof and you should not rely upon forward-looking statements as predictions of future events. The events and circumstances reflected in the forward-looking statements may not be achieved or occur. Although we believe that the expectations reflected in the forward-looking statements are reasonable, we cannot guarantee future results, performance, or achievements. We undertake no obligation to update any of these forward-looking statements for any reason after the date of this press release or to conform these statements to actual results or revised expectations, except as required by law. Undue reliance should not be placed on forward-looking statements.
U.S. Food and Drug Administration (FDA) review of oxylanthanum carbonate (OLC) New Drug Application (NDA) resubmission remains on track, with a Prescription Drug User Fee Act (PDUFA) target action date of June 29, 2026
Commercial readiness activities continue in anticipation of the potential commercial launch of OLC
MOUNTAIN VIEW, Calif., May 12, 2026 (GLOBE NEWSWIRE) — Unicycive Therapeutics, Inc. (Nasdaq: UNCY), a clinical-stage biotechnology company developing therapies for patients with kidney disease, today announced its financial results for the first quarter ended March 31, 2026, and provided a business update.
“As we approach the June 29th PDUFA target action date, we remain optimistic about the potential approval of OLC and focused on preparations for the subsequent launch of OLC,” said Shalabh Gupta, M.D., Chief Executive Officer of Unicycive. “Our ongoing dialogue with the FDA during the review cycle has been constructive and timely. Uncontrolled hyperphosphatemia remains a significant health concern, affecting nearly 75% of U.S. patients with chronic kidney disease who are undergoing dialysis. OLC has the potential to improve adherence and phosphorus control with reduced pill burden, compared with currently available phosphate binders.”
Key Highlights & Upcoming Milestones
In January 2026, the Company announced the FDA accepted the resubmission of its NDA for OLC, an investigational oral phosphate binder for the treatment of hyperphosphatemia in patients with CKD on dialysis. The FDA set a PDUFA target action date of June 29, 2026. The NDA is supported by data from three clinical studies (a Phase 1 study in healthy volunteers, a bioequivalence study in healthy volunteers, and a tolerability study in patients with CKD on dialysis), multiple preclinical studies, and chemistry, manufacturing, and controls (CMC) data. The FDA did not raise any concerns regarding the preclinical, clinical, or safety data for OLC included in the original NDA submission. The December 2025 resubmission was based on progress made by the third-party manufacturing vendor responsible for the drug product.
In preparation for a potential launch of OLC later this year, the Company continues to strengthen its commercial infrastructure and advance market readiness initiatives. Unicycive’s goal is to optimize patient access across all reimbursement settings and intends to provide dedicated access and reimbursement support services for all patients through Unicycive’s UniSource™ reimbursement hub.
Financial Results for the Quarter Ended March 31, 2026
As of May 11, 2026, unaudited cash, cash equivalents, and marketable securities totaled $57.1 million. The Company believes that it has sufficient resources to fund planned operations into 2027.
Research and Development (R&D) expense were $1.6 million for the quarter ended March 31, 2026, compared to $2.2 million for the three months ended March 31, 2025. The decrease in research and development expense was primarily attributed to a decrease in drug development costs as well as consulting and professional fees.
General and Administrative (G&A) expense were $6.8 million for the quarter ended March 31, 2026, compared to $5.8 million for the three months ended March 31, 2025. The increase was primarily attributed to an increase in consulting, professional services, and labor costs.
Other income (expense) was $(4.4) million for the quarter ended March 31, 2026, compared to $8.6 million income for the three months ended March 31, 2025, attributed primarily to an increase in the fair value of the Company’s warrant liability.
Net comprehensive income (loss) attributable to common stockholders, basic for the quarter ended March 31, 2026, was $(12.8) million, or $(0.54) per share of common stock, compared to $0.5 million income, or $0.04 per share of common stock, for the three months ended March 31, 2025. Net comprehensive income (loss) attributable to common stockholders, diluted for the quarter ended March 31, 2026, was $(12.8) million, or $(0.54) per share of common stock, compared to $(6.2) million, or $(0.50) per share of common stock, for the three months ended March 31, 2025. The increased net loss for the quarter ended March 31, 2026, was attributed primarily to an increase in the fair value of the Company’s warrant liability.
About Unicycive Therapeutics
Unicycive Therapeutics is a biotechnology company developing novel treatments for kidney diseases. Unicycive’s lead investigational treatment is oxylanthanum carbonate, a novel phosphate binding agent currently under review by the U.S. Food and Drug Administration (FDA) for the treatment of hyperphosphatemia in patients with chronic kidney disease who are on dialysis. Unicycive’s second investigational treatment UNI-494 is intended for the treatment of conditions related to acute kidney injury. It has been granted orphan drug designation (ODD) by the FDA for the prevention of Delayed Graft Function (DGF) in kidney transplant patients and has completed a Phase 1 dose-ranging safety study in healthy volunteers. For more information, please visit Unicycive.com and follow us on LinkedIn and X.
Forward-looking statements
Certain statements in this press release are forward-looking within the meaning of the Private Securities Litigation Reform Act of 1995. These statements may be identified using words such as “anticipate,” “believe,” “forecast,” “estimated” and “intend” or other similar terms or expressions that concern Unicycive’s expectations, strategy, plans or intentions. These forward-looking statements are based on Unicycive’s current expectations and actual results could differ materially. There are several factors that could cause actual events to differ materially from those indicated by such forward-looking statements. These factors include, but are not limited to, clinical trials involve a lengthy and expensive process with an uncertain outcome, and results of earlier studies and trials may not be predictive of future trial results; our clinical trials may be suspended or discontinued due to unexpected side effects or other safety risks that could preclude approval of our product candidates; our dependence on third parties for manufacturing; risks related to business interruptions, which could seriously harm our financial condition and increase our costs and expenses; dependence on key personnel; substantial competition; uncertainties of patent protection and litigation; dependence upon third parties; market acceptance of our products; and risks related to failure to obtain FDA clearances or approvals and noncompliance with FDA regulations. Actual results may differ materially from those indicated by such forward-looking statements as a result of various important factors, including: the uncertainties related to market conditions and other factors described more fully in the section entitled ‘Risk Factors’ in Unicycive’s Annual Report on Form 10-K for the year ended December 31, 2025, and other periodic reports filed with the Securities and Exchange Commission. Any forward-looking statements contained in this press release speak only as of the date hereof, and Unicycive specifically disclaims any obligation to update any forward-looking statement, whether as a result of new information, future events or otherwise.
