Moleculin Reports Positive Topline Efficacy Results from U.S. Phase 1B/2 Clinical Trial Evaluating Annamycin for the Treatment of Soft Tissue Sarcoma Lung Metastases (MB-107)
Responders (Stable Disease or Partial Response) after 2 cycles of Annamycin showed improvement in OS and Progression Free Survival ('PFS')
Clinical Benefit Rate ('CBR') was 59.4% (n=32), comprised of 18 subjects with stable disease and 1 subject with a partial response
Potential to address 13,500 new incidents of STS each year and market opportunity expected to grow to $2.6B by 20301
On-demand video webcast with members of the Moleculin management team and internationally renowned Key Opinion Leaders available Thursday, June 5th
HOUSTON, June 04, 2025 (GLOBE NEWSWIRE) -- Moleculin Biotech, Inc., (Nasdaq: MBRX) ('Moleculin' or the 'Company'), a late-stage pharmaceutical company with a broad portfolio of drug candidates targeting hard-to-treat cancers and viruses, today reported positive topline efficacy results from its completed U.S. Phase 1B/2 clinical trial evaluating Annamycin for the treatment of soft tissue sarcoma lung metastases ('STS lung mets') (MB-107).
The MB-107 trial was a multi-center, open-label, single-arm monotherapy study that in Phase 1B determined the Maximum Tolerable Dose and Recommended Phase 2 Dose ('MTD', 'RP2D' respectively) and safety of Annamycin and in Phase 2 explored the efficacy of Annamycin as a single agent for the treatment of subjects with STS lung mets for which chemotherapy was considered appropriate. For more information about the MB-107 trial visit clinicaltrials.gov and reference identifier NCT04887298.
'These positive topline results from MB-107 are incredibly encouraging. The impact Annamycin demonstrated on median overall survival, particularly with patients who received multiple prior chemotherapy regimens, exceeded expectations. Additionally, the improvement seen with PFS after two doses represents a real potential for Annamycin to provide a meaningful treatment option for the treatment of STS lung mets,' commented Walter Klemp, Chairman and Chief Executive Officer of Moleculin. 'Looking ahead, we believe these results strongly support further evaluations of Annamycin for the treatment of STS lung mets and we look forward to exploring opportunities to potentially bring this important treatment option to patients.'
Topline Efficacy Results Summary
Annamycin currently has Fast Track Status and Orphan Drug Designation from the FDA for the treatment of relapsed or refractory acute myeloid leukemia, in addition to Orphan Drug Designation for the treatment of soft tissue sarcoma. Furthermore, Annamycin has Orphan Drug Designation for the treatment of relapsed or refractory acute myeloid leukemia from the EMA.
On-Demand Webcast Details
An on-demand Virtual STS Lung Mets KOL Webcast to discuss the MB-107 data will be available for investors, analysts, and other interested parties on Thursday, June 5, 2025 beginning at 8:30 AM ET.
For the event, Walter Klemp, Chairman and Chief Executive Officer, and Dr. Paul Waymack, Senior Chief Medical Officer of Moleculin will be joined by Key Opinion Leaders: Mohamad Cherry, MD, Medical Director of Hematology at Atlantic Health System; Prof. Bernd Kasper, Sarcoma Unit of the Mannheim Cancer Center (MCC) at the Mannheim University Medical Center, University of Heidelberg; and Sant P. Chawla, MD, Director, Sarcoma Oncology Center, Director, Cancer Center of Southern California.
Interested participants and investors may access the on-demand video webcast on the Events page of the Investors section of the Moleculin website, moleculin.com. The webcast will be accessible for 90 days.
About STS Lung Mets
Soft tissue sarcoma is a type of cancer that originates in the soft tissues of the body, including muscles, tendons, fat, blood vessels and nerves. Lung metastases are a common occurrence in STS, and can impact overall survival. According to The American Cancer Society approximately 13,500 individuals, both adults and children, will be diagnosed with soft tissue sarcoma in 20252. Soft tissue sarcomas account for 1% of all adult cancers, 7% of cancers in children up to age 15, and 3% of cancers in children under the age of 14. The Soft Tissue Sarcoma Market was valued at USD 1.58 Billion in 2024, and is expected to reach USD 2.57 Billion by 2030, rising at a CAGR of 8.43%. OS for standard of care for metastatic STS has been estimated at 8-12 months and certain experimental targeted and cytotoxic therapies (as monotherapies or some in combination) have yielded OS of 13.4 months as second line therapy.3
MB-107 Study Design
In Phase 2, Annamycin was administered as an intravenous (IV) infusion over 2 hours on Day 1, followed by 20 days off (1 cycle = 21 days). Subjects visit the study site every 21 days (±3 days) at which time safety monitoring – including for adverse events (AEs), as well as a physical examination, laboratory evaluations (clinical chemistry, complete blood count), vital signs, weight measurements, Eastern Cooperative Oncology Group (ECOG) performance status, and electrocardiograms (ECGs) – is performed, followed by an IV infusion of study drug. Cardiac function is followed by echocardiogram (ECHO) scans at screening, at the end of the first two cycles and then following every other cycle thereafter, at the End of Treatment visit, and if feasible, during follow up at 6 months (±1 month) and 1 year (±1 month) after study drug discontinuation. As long as the Investigator considers that the benefits of treatment with Annamycin continue to outweigh the risks, treatment will continue every 21 days until tumor progression is observed or unacceptable toxicity occurs.
Tumor response is monitored every 6 weeks (±1 week) from Cycle 1 Day 1 during treatment, at the End of Treatment visit, and then every 3 months (±1 month) until disease progression using RECIST 1.1 criteria. Those subjects who leave the study after a maximum response is achieved and who do not start another therapy will be followed every 3 months (±1 month) for progression-free survival (PFS). If a subject receives further therapy after discontinuing from the study, they will be followed only for overall survival (OS) and if feasible, follow-up ECHO scans at 6 months (±1 month) and 1 year (±1 month) were conducted after study drug discontinuation.
About Moleculin Biotech, Inc.
Moleculin Biotech, Inc. is a Phase 3 clinical stage pharmaceutical company advancing a pipeline of therapeutic candidates addressing hard-to-treat tumors and viruses. The Company's lead program, Annamycin, is a next-generation highly efficacious and well tolerated anthracycline designed to avoid multidrug resistance mechanisms and to lack the cardiotoxicity common with currently prescribed anthracyclines. Annamycin is currently in development for the treatment of relapsed or refractory acute myeloid leukemia (AML) and soft tissue sarcoma (STS) lung metastases.
The Company has begun the MIRACLE (Moleculin R/R AML AnnAraC Clinical Evaluation) Trial (MB-108), a pivotal, adaptive design Phase 3 trial evaluating Annamycin in combination with cytarabine, together referred to as AnnAraC, for the treatment of relapsed or refractory acute myeloid leukemia. Following a successful Phase 1B/2 study (MB-106), with input from the FDA, the Company believes it has substantially de-risked the development pathway towards a potential approval for Annamycin for the treatment of AML. This study remains subject to appropriate future filings with potential additional feedback from the FDA and their foreign equivalents.
Additionally, the Company is developing WP1066, an Immune/Transcription Modulator capable of inhibiting p-STAT3 and other oncogenic transcription factors while also stimulating a natural immune response, targeting brain tumors, pancreatic and other cancers. Moleculin is also engaged in the development of a portfolio of antimetabolites, including WP1122 for the potential treatment of pathogenic viruses, as well as certain cancer indications.
For more information about the Company, please visit www.moleculin.com and connect on X, LinkedIn and Facebook.
Forward-Looking Statements
Some of the statements in this release are forward-looking statements within the meaning of Section 27A of the Securities Act of 1933, Section 21E of the Securities Exchange Act of 1934 and the Private Securities Litigation Reform Act of 1995, which involve risks and uncertainties. Forward-looking statements in this press release include, without limitation, the timing of the release of the initial data on the first 45 subjects in the trial and the Company's ability to reconcile the US and EU protocols with the FDA and EMA, respectively. Moleculin will require significant additional financing, for which the Company has no commitments, in order to conduct its clinical trials as described in this press release, and the milestones described in this press release assume the Company's ability to secure such financing on a timely basis. Although Moleculin believes that the expectations reflected in such forward-looking statements are reasonable as of the date made, expectations may prove to have been materially different from the results expressed or implied by such forward-looking statements. Moleculin has attempted to identify forward-looking statements by terminology including 'believes,' 'estimates,' 'anticipates,' 'expects,' 'plans,' 'projects,' 'intends,' 'potential,' 'may,' 'could,' 'might,' 'will,' 'should,' 'approximately' or other words that convey uncertainty of future events or outcomes to identify these forward-looking statements. These statements are only predictions and involve known and unknown risks, uncertainties, and other factors, including those discussed under Item 1A. 'Risk Factors' in our most recently filed Form 10-K filed with the Securities and Exchange Commission (SEC) and updated from time to time in our Form 10-Q filings and in our other public filings with the SEC. Any forward-looking statements contained in this release speak only as of its date. We undertake no obligation to update any forward-looking statements contained in this release to reflect events or circumstances occurring after its date or to reflect the occurrence of unanticipated events.
Investor Contact:
JTC Team, LLC
Jenene Thomas
(908) 824-0775
[email protected]
1 https://www.researchandmarkets.com/reports/5893492/soft-tissue-sarcoma-market-global-industry
2 American Cancer Society. Cancer Facts & Figures 2025. Atlanta: American Cancer Society; 2025. Available at https://www.cancer.org/research/cancer-facts-statistics/all-cancer-facts-figures/2025-cancer-facts-figures.html
3 Comandone A, et al; 'Salvage Therapy in Advanced Adult Soft Tissue Sarcoma: A Systematic Review and Meta-Analysis of Randomized Trials'; The Oncologist 2017;22:1518–1527
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Forward-Looking Statements This press release and the conference call referencing this press release contain 'forward-looking' statements, as that term is defined under the federal securities laws, including but not limited to statements regarding Laird Superfood's anticipated cash runway, future financial performance, and growth. Such forward-looking statements may be identified by words such as "anticipates," "believes," "continues," "could," "estimates," "expects," "intends," "may," "outlook," "plans," "potential," predicts," "projects," "seeks," "should," "will," "would", or the antonyms of these terms or other comparable terminology. These forward-looking statements are based on Laird Superfood's current assumptions, expectations and beliefs and are subject to substantial risks, uncertainties, assumptions and changes in circumstances that may cause Laird Superfood's actual results, performance or achievements to differ materially from those expressed or implied in any forward-looking statement. We expressly disclaim any obligation to update or alter any forward-looking statements, whether as a result of new information, future events or otherwise, except as required by law. The risks and uncertainties referred to above include, but are not limited to: (1) the effects of global outbreaks of pandemics or contagious diseases or fear of such outbreaks, including on our supply chain, the demand for our products, and on overall economic conditions and consumer confidence and spending levels; (2) volatility regarding our revenue, expenses, including shipping expenses, and other operating results; (3) our ability to acquire new direct and wholesale customers and successfully retain existing customers; (4) our ability to attract and retain our suppliers, distributors and co-manufacturers, and effectively manage their costs and performance; (5) effects of real or perceived quality or health issues with our products or other issues that adversely affect our brand and reputation; (6) our ability to innovate on a timely and cost-effective basis, predict changes in consumer preferences and develop successful new products, or updates to existing products, and develop innovative marketing strategies; (7) adverse developments regarding prices and availability of raw materials and other inputs, a substantial amount of which come from a limited number of suppliers outside the United States, including in areas which may be adversely affected by climate change; (8) effects of changes in the tastes and preferences of our consumers and consumer preferences for natural and organic food products; (9) the financial condition of, and our relationships with, our suppliers, co-manufacturers, distributors, retailers and food service customers, as well as the health of the food service industry generally; (10) the ability of ourselves, our suppliers and co-manufacturers to comply with food safety, environmental or other laws or regulations; (11) our plans for future investments in our business, our anticipated capital expenditures and our estimates regarding our capital requirements, including our ability to continue as a going concern; (12) the costs and success of our marketing efforts, and our ability to promote our brand; (13) our reliance on our executive team and other key personnel and our ability to identify, recruit and retain skilled and general working personnel; (14) our ability to effectively manage our growth; (15) our ability to compete effectively with existing competitors and new market entrants; (16) the impact of adverse economic conditions; (17) the growth rates of the markets in which we compete, and (18) the other risks described in our Annual Report on Form 10-K for the year ended December 31, 2024 and other filings we make with the Securities and Exchange Commission. 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CONSOLIDATED BALANCE SHEETS (unaudited) As of June 30, 2025 December 31, 2024 Assets Current assets Cash, cash equivalents, and restricted cash $ 4,184,775 $ 8,514,152 Accounts receivable, net 2,751,541 1,762,911 Inventory 11,027,615 5,975,676 Prepaid expenses and other current assets 1,253,258 1,713,889 Total current assets 19,217,189 17,966,628 Noncurrent assets Property and equipment, net 93,233 58,447 Intangible assets, net 816,078 896,123 Related party license agreements 132,100 132,100 Right-of-use assets 168,136 205,703 Total noncurrent assets 1,209,547 1,292,373 Total assets $ 20,426,736 $ 19,259,001 Liabilities and Stockholders' Equity Current liabilities Accounts payable $ 2,726,595 $ 2,137,760 Accrued expenses 4,066,255 3,642,998 Related party liabilities 57,947 34,947 Lease liabilities, current portion 107,555 105,966 Total current liabilities 6,958,352 5,921,671 Lease liabilities 94,443 140,464 Total liabilities 7,052,795 6,062,135 Stockholders' equity Common stock, $0.001 par value, 100,000,000 shares authorized at June 30, 2025 and December 31, 2024; 11,020,792 and 10,644,461 issued and outstanding at June 30, 2025, respectively; and 10,668,705 and 10,292,374 issued and outstanding at December 31, 2024, respectively. 10,644 10,292 Additional paid-in capital 121,999,967 121,304,884 Accumulated deficit (108,636,670 ) (108,118,310 ) Total stockholders' equity 13,373,941 13,196,866 Total liabilities and stockholders' equity $ 20,426,736 $ Expand LAIRD SUPERFOOD, INC. NON-GAAP FINANCIAL MEASURES (unaudited) In this press release, we report Adjusted EBITDA and Adjusted EBITDA per diluted share, which are financial measures not required by, or presented in accordance with, accounting principles generally accepted in the United States of America ('GAAP'). The Company's management uses non-GAAP financial measures, both internally and externally, to assess and communicate the financial performance of the Company. The Company defines Adjusted EBITDA as net income (loss), adjusted to exclude: (1) interest expense and other (income) loss, (2) income tax (benefit) expense, (3) depreciation and amortization expenses, (4) stock-based compensation, and (5) expenses and recoveries related to a product quality issue. The Company believes Adjusted EBITDA is useful to investors because it facilitates comparisons of its core business operations, excluding non-cash costs and non-recurring events, across periods on a consistent basis. 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Some of these limitations are that Adjusted EBITDA does not reflect, among other things: cash capital expenditures for assets underlying depreciation and amortization expense that may need to be replaced or for new capital expenditures; interest expense; income tax expense from continuing operations; our working capital requirements; the potentially dilutive impact of stock-based compensation; and the provision for income taxes. Other companies, including companies in our industry, may calculate Adjusted EBITDA differently, which reduces its usefulness as a comparative measure. Because of these limitations, you should consider Adjusted EBITDA along with other financial performance measures, including Net Sales, net loss, cash and cash equivalents, restricted cash, net cash used in operating activities and our financial results presented in accordance with GAAP. 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MINNEAPOLIS--(BUSINESS WIRE)--SunOpta Inc. ('SunOpta' or the 'Company') (Nasdaq: STKL) (TSX:SOY), a company that delivers customized supply chain solutions and innovation for top brands, retailers and foodservice providers across a broad portfolio of beverages, broths and better-for-you snacks today announced financial results for the second quarter ended June 28, 2025. 'Second quarter results were outstanding, reflecting the strength of our competitive position and sharp execution by our team,' said Brian Kocher, Chief Executive Officer of SunOpta. Share All amounts are expressed in U.S. dollars and results are reported in accordance with U.S. GAAP, except where specifically noted. Second Quarter 2025 highlights: Revenues of $191.5 million increased 12.9% compared to $169.5 million in the prior year period, driven by 14.4% volume growth partially offset by a 1.4% price reduction for pass-through pricing for certain raw material cost savings Earnings from continuing operations of $4.4 million compared to a loss of $4.4 million in the prior year period Adjusted earnings¹ from continuing operations of $4.4 million compared to $2.2 million in the prior year period Adjusted earnings per share¹ from continuing operations of $0.04 compared to $0.02 in the prior year period Adjusted EBITDA¹ from continuing operations increased 13.9% to $22.7 million, or 11.9% of revenues, compared to $20.0 million, or 11.8% of revenues, in the prior year period 'Second quarter results were outstanding, reflecting the strength of our competitive position and sharp execution by our team,' said Brian Kocher, Chief Executive Officer of SunOpta. 'Both revenue and Adjusted EBITDA growth continued their double-digits trajectory, driven by robust volume gains across the breadth of our diverse portfolio. Earnings growth was equally strong. We also made significant progress advancing our operational initiatives to improve margins, including unlocking capacity and improving yields, which we expect to gain additional traction over the balance of 2025.' Kocher continued, 'Our new business pipeline has never been stronger and we are exceptionally well positioned to capitalize on these opportunities to drive sustainable growth and profitability. Across beverages and fruit snacks we can meet our growth requirements through 2026 with existing assets. Especially in the better-for-you fruit snack category, powerful tailwinds have significantly increased customer demand. Accordingly, we are announcing a new fruit snack manufacturing line at our Omak, Washington facility, that is already over-subscribed and is anticipated to come online in late 2026 to meet this demand for 2027 and beyond.' Second Quarter 2025 Results Revenues increased 12.9% to $191.5 million for the second quarter of 2025. The increase was driven by 14.4% volume growth partially offset by a 1.4% price reduction for pass-through pricing for certain raw material cost savings. Growth in volume/mix reflected volume growth for plant-based beverages, broth and fruit snacks as well as new product launches. Gross profit increased $7.2 million, or 34.0%, to $28.4 million for the quarter ended June 28, 2025, compared with $21.2 million for the quarter ended June 29, 2024. Gross margin was 14.8% for the quarter ended June 28, 2025, compared with 12.5% for the quarter ended June 29, 2024, an increase of 230 basis points. Adjusted gross margin¹, was 15.2% for the quarter ended June 28, 2025, compared with 16.0% for the quarter ended June 29, 2024. The 80-basis point decrease in adjusted gross margin reflects the timing lag on the pass-through of incremental tariff costs, investments in labor and infrastructure to improve long-term margins and incremental depreciation related to assets recently placed in service. These factors were partially offset by higher sales and production volumes for beverages, broths and fruit snacks driving improved plant utilization. Operating income increased by $8.5 million, to $10.5 million, compared to $2.0 million in the second quarter of 2024, reflecting higher gross profit and a favorable foreign exchange impact. Earnings from continuing operations increased 198% to $4.4 million for the second quarter of 2025 compared with a loss of $4.4 million in the prior year period. Diluted earnings per share from continuing operations attributable to common shareholders (after dividends and accretion on preferred stock) was $0.03 for the second quarter compared with diluted loss per share of $0.04 in the prior year period. Adjusted earnings¹ from continuing operations were $4.4 million or $0.04 per diluted share in the second quarter of 2025 compared to adjusted earnings from continuing operations of $2.2 million or $0.02 per diluted share in the second quarter of 2024. Adjusted EBITDA¹ from continuing operations was $22.7 million in the second quarter of 2025 compared to $20.0 million in the second quarter of 2024 driven by strong volume growth. Please refer to the discussion and table below under 'Non-GAAP Measures'. Balance Sheet and Cash Flow As of June 28, 2025, SunOpta had total assets of $704.9 million and total debt of $273.4 million compared to total assets of $668.5 million and total debt of $265.2 million at year end fiscal 2024. During the first two quarters of fiscal 2025, cash provided by operating activities of continuing operations was $17.8 million compared to $2.0 million during the first two quarters of fiscal 2024. The increase mainly reflected improved working capital efficiency, together with increased operating income, driven by revenue growth. Investing activities of continuing operations consumed $18.6 million of cash during the first two quarters of fiscal 2025 compared to $13.9 million in the first two quarters of fiscal 2024, reflecting higher capital expenditures together with non-recurring proceeds from the sale of the smoothie bowl product line. Net leverage 1 was 2.9x, compared to 3.0x at the end of fiscal 2024 and we continue to expect to achieve our 2.5x net leverage target by the end of this fiscal year. During the second quarter, the Company repurchased 163,227 common shares at an average price per share of $6.04, for total consideration of $1.0 million. As at June 28, 2025, there was $24.0 million of the authorized amount remained available under the Share Repurchase Program. Tariffs Tariffs continue to be an evolving situation that we continue to monitor. While our employees, production facilities, and customers are predominately located in the U.S. (in 2024, 98% of revenue was to U.S.-based customers), we source a portion of our raw material ingredients and packaging globally, and a portion of our fruit snack products are imported into the U.S. from our Niagara, Ontario, facility that are not exempt under USMCA. In response to these tariffs, at the beginning of the year we started communications with our customers regarding our intention to pass-through substantially all the incremental costs to our customers, similar to our pass-through pricing of raw material cost increases. By the middle of July, we successfully implemented new pricing arrangements with all of our customers to mitigate the full amount of known tariff exposure at that time. Due to the timing lag in passing through the tariff pricing adjustments, gross profit was negatively impacted by $1.6 million, reducing gross margin by 90 basis points in the second quarter. We expect to have a similar fiscal third quarter timing lag impact as we recover the recently announced tariff changes on August 1, 2025. While our pass-through mechanisms may have a timing lag, we continue to expect to recover substantially all additional costs of tariffs. 2025 Outlook 2 For fiscal 2025, the Company is raising its revenue outlook reflecting both the strong performance in Q2 and the expected impact of pass-through tariff pricing, and is reaffirming its adjusted EBITDA outlook: The revised outlook includes an increase of approximately $8 million in revenue and $10 million in cost of goods sold in the second half of 2025 simply due to the expected tariff expense, related pass-through pricing to our customers, and timing lag on implementing the pricing. Conference Call SunOpta plans to host a conference call at 5:30 P.M. Eastern time on Wednesday, August 6, 2025, to discuss the second quarter financial results. After prepared remarks, there will be a question and answer period. Investors interested in listening to the live webcast can access a link on SunOpta's website at under the 'Investor Relations' section or directly. A replay of the webcast will be archived and can be accessed for approximately 90 days on the Company's website. This call may be accessed with the toll free dial-in number (800) 715-9871 or international dial-in number (646) 307-1963 using Conference ID: 8323651. The quarterly earnings presentation, including the long-term grow algorithm and capital allocation priorities, can be accessed through the live webcast referenced above, and on SunOpta's website at under the 'Investor Relations' section or directly. 1 See discussion of non-GAAP measures 2 The Company has included certain forward-looking statements about the future financial performance that include non-GAAP financial measures, including Adjusted EBITDA. These non–GAAP financial measures are derived by excluding certain amounts, expenses or income, from the corresponding financial measures determined in accordance with GAAP. The determination of the amounts that are excluded from these non-GAAP financial measures is a matter of management judgment and depends upon, among other factors, the nature of the underlying expense or income amounts recognized in a given period. We are unable to present a quantitative reconciliation of the aforementioned forward-looking non-GAAP financial measures to their most directly comparable forward-looking GAAP financial measures because management cannot reliably predict all of the necessary components of such GAAP measures. Historically, management has excluded the following items from certain of these non-GAAP measures, and such items may also be excluded in future periods and could be significant amounts. Expenses related to the acquisition or divestiture of a business, including business development costs, impairment of assets, integration costs, severance, retention costs and transaction costs; Charges associated with restructuring and cost saving initiatives, including but not limited to asset impairments, accelerated depreciation, severance costs and lease abandonment charges; Asset impairment charges and facility closure costs; Legal settlements or awards; and The tax effect of the above items. About SunOpta SunOpta (Nasdaq: STKL) (TSX: SOY) delivers customized supply chain solutions and innovation for top brands, retailers and foodservice providers across a broad portfolio of beverages, broths and better-for-you snacks. With over 50 years of expertise, SunOpta fuels customers' growth with high-quality, sustainability-forward solutions distributed through retail, club, foodservice and e-commerce channels across North America. For more information, visit or follow us on LinkedIn. Forward-Looking Statements Certain statements included in this press release may be considered "forward-looking statements" within the meaning of the United States Private Securities Litigation Reform Act of 1995 and applicable Canadian securities legislation, which are based on information available to us on the date of this release. These forward-looking statements include, but are not limited to, our intention to maintain our disciplined financial approach to deliver sustainable gross margin improvement and continue to generate significant free cash flow, our expectation to continue de-levering our balance sheet, achieve net leverage targets and drive increasing returns on invested capital, share repurchases, our expectations to recover tariff impacts through pass-through pricing, and our anticipated Revenue, Adjusted EBITDA, Revenue growth and Adjusted EBITDA growth for fiscal 2025. Generally, forward-looking statements do not relate strictly to historical or current facts and are typically accompanied by words such as 'potential', 'expect', 'believe', 'anticipate', 'estimates', 'can', 'will', 'target', "should", "would", "plans", 'continue', "becoming", "intend", "confident", "may", "project", "intention", "might", "predict", 'budget', 'forecast' or other similar terms and phrases intended to identify these forward-looking statements. Forward-looking statements are based on information available to the Company on the date of this release and are based on estimates and assumptions made by the Company in light of its experience and its perception of historical trends, current conditions and expected future developments including, but not limited to, the Company's actual financial results; uninterrupted operations and service levels to our customers; current customer demand for the Company's products; general economic conditions; continued consumer interest in health and wellness; the Company's ability to maintain product pricing levels; planned facility and operational expansions, closures and divestitures; cost rationalization and product development initiatives; alternative potential uses for the Company's capital resources; portfolio optimization and productivity efforts; the sustainability of the Company's sales pipeline; the Company's expectations regarding commodity pricing, margins and hedging results; procurement and logistics savings; freight lane cost reductions; yield and throughput enhancements; labor cost reductions; and the terms of our insurance policies. Whether actual timing and results will agree with expectations and predictions of the Company is subject to many risks and uncertainties including, but not limited to, potential loss of suppliers and customers as well as the possibility of supply chain, logistics and other disruptions; unexpected issues or delays with the Company's structural improvements and automation investments; failure or inability to implement portfolio changes, process improvements, go-to-market improvements and process sustainability strategies in a timely manner; changes in the level of capital investment; local and global political and economic conditions; consumer spending patterns and changes in market trends; decreases in customer demand; delayed or unsuccessful product development efforts; potential product recalls; working capital management; availability and pricing of raw materials and supplies; potential covenant breaches under the Company's credit facilities; the impact of the imposition of tariffs, including increases in food prices and inflation, and any resulting negative impacts on the macro-economic environment; and other risks described from time to time under "Risk Factors" in the Company's Annual Report on Form 10-K and its Quarterly Reports on Form 10-Q (available at Consequently, all forward-looking statements made herein are qualified by these cautionary statements and there can be no assurance that the actual results or developments anticipated by the Company will be realized. The Company undertakes no obligation to publicly correct or update the forward-looking statements in this document, in other documents, or on its website to reflect future events or circumstances, except as may be required under applicable securities laws. SunOpta Inc. Consolidated Balance Sheets As at June 28, 2025 and December 28, 2024 (Unaudited) (All dollar amounts expressed in thousands of U.S. dollars) June 28, 2025 December 28, 2024 $ $ ASSETS Current assets Cash and cash equivalents 2,161 1,552 Accounts receivable 58,851 46,314 Inventories 109,945 92,798 Prepaid expenses and other current assets 12,346 14,680 Income taxes recoverable 780 4,114 Total current assets 184,083 159,458 Restricted cash 8,003 7,460 Property, plant and equipment, net 345,968 343,618 Operating lease right-of-use assets 112,138 105,692 Intangible assets, net 22,041 20,077 Goodwill 3,998 3,998 Other long-term assets 28,709 28,224 Total assets 704,940 668,527 LIABILITIES Current liabilities Accounts payable 109,560 93,362 Accrued liabilities 15,189 17,876 Income taxes payable 70 638 Notes payable 8,211 11,110 Short-term debt 10,115 - Current portion of long-term debt 30,176 29,393 Current portion of operating lease liabilities 17,491 17,055 Total current liabilities 190,812 169,434 Long-term debt 233,080 235,798 Operating lease liabilities 105,684 99,328 Deferred income taxes 325 325 Total liabilities 529,901 504,885 Series B-1 Preferred Stock 15,223 15,048 SHAREHOLDERS' EQUITY Common shares 478,064 471,792 Additional paid-in capital 27,070 30,775 Accumulated deficit (347,327 ) (355,982 ) Accumulated other comprehensive income 2,009 2,009 Total shareholders' equity 159,816 148,594 Total liabilities and shareholders' equity 704,940 668,527 Expand SunOpta Inc. Consolidated Statements of Cash Flows For the two quarters ended June 28, 2025 and June 29, 2024 (Unaudited) (All dollar amounts expressed in thousands of U.S. dollars) Two quarters ended June 28, 2025 June 29, 2024 $ $ CASH PROVIDED BY (USED IN) Operating activities Net earnings (loss) 9,162 (2,455 ) Net loss from discontinued operations - (1,814 ) Earnings (loss) from continuing operations 9,162 (641 ) Items not affecting cash: Depreciation and amortization 19,686 17,686 Amortization of debt issuance costs 477 457 Deferred income taxes - (368 ) Stock-based compensation 3,735 7,088 Gain on sale of smoothie bowls product line - (1,800 ) Gain on sale of property, plant and equipment (244 ) - Other (194 ) (193 ) Changes in operating assets and liabilities, net of divestitures (14,844 ) (20,216 ) Net cash provided by operating activities of continuing operations 17,778 2,013 Net cash used in operating activities of discontinued operations - (2,310 ) Net cash provided by (used in) operating activities 17,778 (297 ) Investing activities Additions to property, plant and equipment (17,438 ) (17,259 ) Proceeds from sale of property, plant and equipment 1,284 - Addition to intangible assets (2,419 ) - Proceeds from sale of smoothie bowls product line - 3,336 Net cash used in investing activities of continuing operations (18,573 ) (13,923 ) Net cash provided by investing activities of discontinued operations - 6,300 Net cash used in investing activities (18,573 ) (7,623 ) Financing activities Proceeds from notes payable 80,070 70,477 Repayment of notes payable (82,969 ) (71,709 ) Net increase in borrowings under revolving credit facilities 6,762 26,350 Borrowings of short-term and long-term debt 18,600 - Repayment of long-term debt (19,016 ) (12,320 ) Proceeds from the exercise of stock options and employee share purchases 1,880 749 Payment of withholding taxes on stock-based awards (2,389 ) (2,659 ) Repurchase of common shares (991 ) - Payment of cash dividends on preferred stock - (305 ) Net cash provided by financing activities of continuing operations 1,947 10,583 Increase in cash, cash equivalents and restricted cash in the period 1,152 2,663 Cash, cash equivalents and restricted cash, beginning of the period 9,012 8,754 Cash, cash equivalents and restricted cash, end of the period 10,164 11,417 Expand Non-GAAP Measures Adjusted Gross Margin Gross margin is a measure of gross profit (equal to revenues less cost of goods sold) as a percentage of revenues. The Company uses a measure of adjusted gross margin that excludes unusual items that are identified and evaluated on an individual basis, which due to their nature or size, the Company would not expect to occur as part of our normal business on a regular basis. The Company uses the measure of adjusted gross margin to evaluate the underlying profitability of our revenue-generating activities within each reporting period. The Company believes that disclosing this non-GAAP measure provides users with a meaningful, consistent comparison of its profitability measure for the periods presented. However, the non-GAAP measure of adjusted gross margin should not be considered in isolation or as a substitute for gross margin calculated based on gross profit determined in accordance with U.S. GAAP. The following tables present a reconciliation of adjusted gross margin from reported gross margin calculated in accordance with U.S. GAAP (all dollar amounts expressed in thousands of U.S. dollars). Adjusted Earnings When assessing financial performance, the Company uses an internal measure of adjusted earnings that excludes specific items recognized in other income or expense, and other unusual items that are identified and evaluated on an individual basis, which due to their nature or size, the Company would not expect to occur as part of its normal business on a regular basis. The Company believes that the identification of these excluded items enhances the analysis of the financial performance of its business when comparing those operating results between periods, as the Company does not consider these items to be reflective of normal business operations. The following tables present a reconciliation of adjusted earnings from earnings (loss) from continuing operations, which the Company considers to be the most directly comparable U.S. GAAP financial measure (all dollar amounts expressed in thousands of U.S. dollars, except per share amounts). First Two Quarters Ended June 28, 2025 June 29, 2024 Per Share Per Share $ $ $ $ Earnings (loss) from continuing operations 9,162 (641 ) Accretion on preferred stock (175 ) (264 ) Earnings (loss) from continuing operations attributable to common shareholders 8,987 0.07 (905 ) (0.01 ) Adjusted for: Wastewater haul-off charges (a) 1,295 1,426 Start-up costs (b) - 2,675 Product withdrawal costs (c) - 2,145 Unrealized foreign exchange loss (gain) on restricted cash (d) (543 ) 838 Other (e) (56 ) (304 ) Gain on sale of smoothie bowls product line (f) - (1,800 ) Adjusted earnings from continuing operations 9,683 0.08 4,075 0.03 Expand Adjusted EBITDA The Company uses a measure of adjusted EBITDA from continuing operations when assessing the performance of its operations, which the Company believes is useful to users' understanding of the Company's operating profitability because it excludes non-operating expenses, such as interest, loss on sale of receivables, and income taxes, as well as non-cash expenses, such as depreciation, amortization, and stock-based compensation. In addition, the Company's measure of adjusted EBITDA excludes other unusual items that affect the comparability of its operating performance, as identified in the preceding determination of adjusted earnings from continuing operations. The Company also uses this measure of adjusted EBITDA to assess operating performance in connection with its employee incentive programs. The following tables present a reconciliation of adjusted EBITDA from continuing operations from earnings (loss) from continuing operations, which the Company considers to be the most directly comparable U.S. GAAP financial measure (all dollar amounts expressed in thousands of U.S. dollars). Second Quarter Ended June 28, 2025 June 29, 2024 $ $ Earnings (loss) from continuing operations 4,351 (4,437 ) Interest expense, net 5,301 6,410 Loss on sale of receivables* 537 - Income tax expense (benefit) 344 (17 ) Depreciation and amortization 9,960 9,110 Stock-based compensation 2,192 2,443 Adjusted for: Wastewater haul-off charges (a) 752 1,426 Start-up costs (b) - 2,348 Product withdrawal costs (c) - 2,145 Unrealized foreign exchange loss (gain) on restricted cash (d) (562 ) 838 Other (e) (131 ) (304 ) Adjusted EBITDA from continuing operations 22,744 19,962 * Included in other non-operating expense. Expand First Two Quarters Ended June 28, 2025 June 29, 2024 $ $ Earnings (loss) from continuing operations 9,162 (641 ) Interest expense, net 10,408 12,460 Loss on sale of receivables* 959 - Income tax expense 491 260 Depreciation and amortization 19,686 17,686 Stock-based compensation 3,735 7,088 Adjusted for: Wastewater haul-off charges (a) 1,295 1,426 Start-up costs (b) - 2,675 Product withdrawal costs (c) - 2,145 Unrealized foreign exchange loss (gain) on restricted cash (d) (543 ) 838 Other (e) (56 ) (304 ) Gain on sale of smoothie bowls product line (f) - (1,800 ) Adjusted EBITDA from continuing operations 45,137 41,833 * Included in other non-operating expense. Expand Footnotes (a) Reflects temporary third-party haul-off charges for excess wastewater produced at our Midlothian, Texas, facility due to volume constraints within our current treatment system. (b) Start-up costs mainly reflect the scale-up of production over the course of fiscal 2024 at our plant-based beverage facility in Midlothian, Texas. (c) Reflects certain direct costs, net of expected insurance recoveries, related to the voluntary withdrawal from customers in the second quarter of 2024 of certain batches of aseptically-packaged products. (d) Reflects unrealized foreign exchange (gains) or losses associated with peso-denominated restricted cash held in Mexico. (e) For the second quarter and first two quarters of 2025, other mainly reflects a gain on sale of property, plant and equipment, partially offset by a legal settlement loss. For the second quarter and first two quarters of 2024, other mainly reflects legal settlement gains. These other amounts are recorded in other income or expense. (f) Reflects the pre-tax gain on sale of the smoothie bowls product line in the first quarter of 2024, which is recorded in other income. Expand Net Leverage Net leverage is a non-GAAP financial measure that is calculated by dividing net debt (non-GAAP) by trailing four quarters adjusted EBITDA (non-GAAP). Net debt is defined by the Company as short-term debt plus current portion of long-term debt plus long-term debt less cash and cash equivalents. The Company uses net leverage as an assessment of its operating performance relative to its debt levels. The following tables present reconciliations of trailing four quarters adjusted EBITDA from continuing operations from loss from continuing operations and total debt to net debt, and the calculation of net leverage (all dollar amounts expressed in thousands of U.S. dollars). Trailing Four Quarters Ended June 28, 2025 December 28, 2024 $ $ Loss from continuing operations (1,671 ) (11,474 ) Interest expense, net 22,856 24,908 Loss on sale of receivables* 1,645 686 Income tax expense 1,701 1,470 Depreciation and amortization 38,497 36,497 Stock-based compensation 7,837 11,190 Adjusted for: Wastewater haul-off charges 4,230 4,361 Start-up costs 16,474 19,149 Product withdrawal costs - 2,145 Unrealized foreign exchange loss on restricted cash 226 1,607 Other 215 (33 ) Gain on sale of smoothie bowls product line - (1,800 ) Adjusted EBITDA from continuing operations 92,010 88,706 * Included in other non-operating expense. Expand $ As at June 28, 2025 Short-term debt 10,115 Current portion of long-term debt 30,176 Long-term debt 233,080 Total debt 273,371 Cash and cash equivalents (2,161 ) Net debt 271,210 For the trailing four quarters ended June 28, 2025 Adjusted EBITDA 92,010 Net leverage 2.9x As at December 28, 2024 Current portion of long-term debt 29,393 Long-term debt 235,798 Total debt 265,191 Cash and cash equivalents (1,552 ) Net debt 263,639 For the trailing four quarters ended December 28, 2024 Adjusted EBITDA 88,706 Net leverage 3.0x Expand
