Preclinical Studies Will Compare C1-Produced Antibodies to Their CHO-Produced Counterparts

JUPITER, Fla., Nov. 12, 2026 (GLOBE NEWSWIRE) — Dyadic International, Inc. (“Dyadic” or the “Company”) (NASDAQ: DYAI), operating as Dyadic Applied BioSolutions, today announced that the Gates Medical Research Institute has initiated preclinical animal studies comparing monoclonal antibodies (mAbs) against respiratory syncytial virus (RSV) and malaria, produced using Dyadic’s proprietary C1 protein production platform, with their respective mammalian-cell (CHO)-produced counterparts.

The studies include four distinct groups of mice, evaluating the pharmacokinetics of a C1-produced RSV antibody, RSM01, and a C1-produced malaria antibody, MAM01, against GMP CHO-produced versions of each mAb.

The studies represent an important preclinical advancement in evaluating C1 as a potentially faster, lower-cost, and more scalable alternative to conventional mammalian-cell manufacturing of therapeutic antibodies.

RSV is a major cause of lower respiratory tract disease in children worldwide. Malaria also remains a significant cause of morbidity and mortality, with the greatest burden occurring in sub-Saharan Africa. Dyadic is pursuing this work in the context of potential future applications in low- and middle-income countries (LMICs), where access to biologic medicines may be constrained by manufacturing complexity, cost and healthcare infrastructure.

The studies follow independent laboratory evaluations of antibodies produced using Dyadic’s C1 platform. Duke University conducted binding studies of both C1-produced RSM01 (RSV) and MAM01 (malaria), while IQVIA conducted neutralization testing of C1-produced RSM01. The newly initiated animal studies will evaluate the pharmacokinetics of C1-produced RSV and malaria antibodies through direct comparisons with their respective CHO-produced counterparts and aim to generate additional preclinical data to support their continued advancement toward potential clinical development.

Under its Gates Foundation-funded program, Dyadic achieved production yields of approximately 12.1 g/L for RSV antibody RSM01 and 13.2 g/L for malaria antibody MAM01 in seven-day fermentation runs. These development-stage results, combined with C1’s ability to produce antibodies with targeted human-like glycosylation profiles, highlight the platform’s potential to manufacture complex biologics efficiently while reducing production costs and increasing manufacturing flexibility.

“This represents an important milestone in demonstrating the broader commercial potential of our C1 platform,” said Mark Emalfarb, Founder and Chief Executive Officer of Dyadic. “The combination of strong productivity, targeted human-like glycosylation and independent laboratory evaluations supports our continued development of C1 as a potentially competitive alternative to traditional mammalian-cell manufacturing. Importantly, advancing these antibodies into animal studies provides another opportunity to evaluate the platform’s capabilities as we work toward making biologics more accessible and affordable worldwide.”

Beyond the RSV and malaria programs, Dyadic believes these results have broader implications for the manufacturing of monoclonal antibodies and other complex therapeutic proteins. Conventional CHO-based manufacturing requires substantial capital investment and operating costs, which can limit the affordability and availability of biologic medicines.

Dyadic’s C1 platform is designed to address these challenges by combining high protein productivity, accelerated development and manufacturing timelines, and scalable, cost-efficient fermentation processes, with the potential to significantly reduce manufacturing costs, expand production capacity, and improve global access to a broad range of biologic medicines.

The animal studies, initiated October 20, 2026, are expected to generate results in the first quarter of 2027. Positive outcomes could support further development of these antibodies and provide additional validation of C1’s potential for broader applications in biologics manufacturing.

About Dyadic Applied BioSolutions

Dyadic Applied BioSolutions is a global biotechnology company that uses its proprietary microbial platforms to produce recombinant proteins that are sold or licensed to partners across the life sciences, food and nutrition, and bio-industrial markets. These high-quality proteins are designed to enable customers to develop more efficient, scalable, and sustainable products. Dyadic’s C1 and Dapibus™ expression systems support flexible, cost-effective manufacturing, and are the foundation of a growing portfolio of commercial and partnered programs.

For more information about Dyadic, please visit www.dyadic.com.

Safe Harbor Regarding Forward-Looking Statements

This press release contains forward-looking statements within the meaning of Section 27A of the Securities Act and Section 21E of the Exchange Act, including those regarding Dyadic’s expectations, intentions, strategies, and beliefs pertaining to future events or future financial performance, such as the success of Dyadic’s clinical trial and interest in its protein production platforms, Dyadic’s research projects and third-party collaborations, as well as the availability of necessary funding. Forward-looking statements involve many risks, uncertainties or other factors beyond Dyadic’s control. These factors include, but are not limited to, the following: (i) Dyadic’s history of net losses; (ii) market and regulatory acceptance of Dyadic’s microbial protein production platforms and other technologies; (iii) failure to commercialize Dyadic’s microbial protein production platforms or its other technologies; (iv) competition, including from alternative technologies; (v) the results of nonclinical studies and clinical trials; (vi) Dyadic’s capital needs; (vii) changes in global economic and financial conditions; (viii) Dyadic’s reliance on information technology; (ix) Dyadic’s dependence on third parties; (x) government regulations and environmental, social and governance issues; (xi) intellectual property risks; and (xii) Dyadic’s ability to comply with the listing standards of the Nasdaq Stock Market LLC. For a more complete description of the risks that could cause Dyadic’s actual results to differ from its current expectations, please see the section entitled “Risk Factors” in Dyadic’s annual reports on Form 10-K and quarterly reports on Form 10-Q filed with the SEC, as such factors may be updated from time to time in Dyadic’s periodic filings with the SEC, which are accessible on the SEC’s website and at www.dyadic.com. All forward-looking statements speak only as of the date made, and except as required by applicable law, Dyadic assumes no obligation to publicly update any such forward-looking statements for any reason after the date of this press release to conform these statements to actual results or to changes in Dyadic’s expectations.

Contacts

Dyadic Applied BioSolutions
Ping Rawson
Chief Financial Officer
ir@dyadic.com
(561) 743-8333

  • Q3 2026 product revenue of €366 million (+89% Y/Y), comprising €291 million for YORVIPATH®, €59 million for SKYTROFA®, and €16 million for YUVIWEL®
    • Received positive CHMP and COMP opinions recommending EU marketing authorization and maintenance of orphan medicinal product designation for TransCon® CNP
  • Final EC decision for TransCon CNP expected in Q4 2026; first EU launch planned in Germany in Q1 2027
  • Presented Week 52 sentinel cohort data in infants with achondroplasia aged 0 to <2 years showing TransCon CNP stabilized or improved foramen magnum stenosis, and increased linear growth; topline pivotal data expected Q3 2027
  • Conference call today at 8:00 a.m. ET

COPENHAGEN, Denmark, Nov. 12, 2026 (GLOBE NEWSWIRE) — Ascendis Pharma A/S (Nasdaq: ASND) today announced financial results for the third quarter ended September 30, 2026, and provided a business update.

“By always putting patients first, Ascendis has delivered three consecutive approved rare endocrine therapies that are the foundation of our transformation into a leading global biopharmaceutical company,” said Jan Mikkelsen, President and Chief Executive Officer of Ascendis Pharma. “With many label expansion programs, new country launches, and the capabilities to reach patients worldwide and develop new products efficiently, we are well positioned to deliver durable long-term growth.”

Select Highlights & Anticipated Milestones

  • YORVIPATH
    (palopegteriparatide, developed as TransCon PTH)
    • YORVIPATH revenue for the third quarter of 2026 totaled €291 million (+103% Y/Y).
    • In the U.S., new patient demand was consistent with prior quarters. Outside the U.S., new patient demand accelerated through new commercial launches. YORVIPATH is now available commercially or through named patient programs in more than 40 countries.
    • Presented data from pooled analysis of Phase 2 PaTH Forward and Phase 3 PaTHway trials at ASN 2026 demonstrating sustained, clinically meaningful improvements in kidney function in adults with hypoparathyroidism treated with TransCon PTH for up to five years.
    • Results from the Phase 3 PaTHway China and PaTHway Japan trials evaluating TransCon PTH in adults with hypoparathyroidism demonstrated efficacy and safety findings consistent with those reported in the pivotal Phase 3 PaTHway Trial, reinforcing the consistency of results across geographies and ethnicities.
  • SKYTROFA
    (lonapegsomatropin, developed as TransCon hGH)
    • SKYTROFA revenue for the third quarter of 2026 totaled €59 million.
    • Ongoing Phase 3 HighLiGHts basket trial across a range of established growth hormone indications: idiopathic short stature (ISS), SHOX deficiency, Turner syndrome, and small for gestational age (SGA). Completion of enrollment anticipated in the first half of 2027.
  • YUVIWEL
    (navepegritide, developed as TransCon CNP)
    • YUVIWEL revenue for the third quarter of 2026 totaled €16 million.
    • In the U.S., approximately 340 unique YUVIWEL patient enrollments by nearly 150 prescribing healthcare providers, with more than 80% of enrollments approved for reimbursement through October 31, 2026.
    • In the EU, received positive CHMP and COMP opinions recommending marketing authorization as a treatment of achondroplasia in children and maintenance of orphan medicinal product designation, respectively, for once-weekly TransCon CNP. Final EC decision expected during the Q4 2026 with first EU launch planned in Germany in Q1 2027.
    • In select international markets, YUVIWEL is being made available through early access programs, and Ascendis expects to recognize revenue from multiple countries outside of the U.S. and EU in the coming quarters.
    • Presented infant sentinel cohort Week 52 data from the reACHin Trial at ESPE 2026, showing that treatment with once-weekly TransCon CNP stabilized or improved foramen magnum stenosis (a skull bone narrowing that can lead to brain stem and spinal cord compression), as well as linear growth benefits, in infants with achondroplasia aged 0 to <2 years. Pivotal data expected Q3 2027.
    • Expect to enroll first patients in Phase 3 trial evaluating TransCon CNP monotherapy in children with hypochondroplasia in Q4 2026. Expect to initiate a Phase 2 trial in adults with achondroplasia in Q4 2026.
  • TransCon CNP + TransCon hGH Combination Therapy
    (navepegritide plus lonapegsomatropin)
    • Following presentation of additional Week 78 data from the Phase 2 COACH Trial at ASBMR 2026 showing durable increase in healthy, proportional growth in children with achondroplasia, 100% of the 21 enrolled children remain on therapy to date.
    • Initiated Phase 3 cAtCH Trial in children with achondroplasia; expect to complete enrollment in Q2 2027.

Key Financial Highlights

  • Total product revenue for the third quarter of 2026 increased to €366 million, reflecting year-over-year growth of +89%.
  • Total revenue for the third quarter of 2026 was €370 million.
  • Operating profit for the third quarter of 2026 totaled €125 million, reflecting a margin of 34%. On a non-IFRS basis, operating profit was €156 million*, reflecting a margin of 42%*.
  • Net profit for the third quarter of 2026 totaled €74 million, or €1.08 per diluted share. On a non-IFRS basis, net profit was €117 million*, or €1.71 per diluted share*.
  • Cash flow from operating activities was €189 million for the third quarter of 2026; expect full year 2026 cash flow from operating activities of at least €600 million.
  • As of September 30, 2026, cash and cash equivalents totaled €964 million, compared to cash and cash equivalents of €616 million as of December 31, 2025.
  • Through September 30, 2026, repurchased 794,304 Ascendis ordinary shares for total consideration of $186 million.
  • Year to date through November 11, 2026, repurchased 1,998,999 Ascendis ordinary shares for total consideration of $459 million.

* See “Non-IFRS Financial Measures” below for definitions of these non-IFRS measures and a reconciliation to the most directly comparable IFRS measures.

Third Quarter 2026 Financial Results

Total revenue for the third quarter of 2026 was €370 million, compared to €214 million during the same period in 2025. The year-over-year increase in revenue was primarily attributable to the continued growth of YORVIPATH global sales.

Total Revenue
(In EUR’000s)
  Three Months Ended
September 30,
  Nine Months Ended
September 30,
    2026   2025   2026   2025
Revenue
Commercial products   365,690   193,790   921,452   443,480
Other revenue
Milestones   —   12,922   17,046   12,922
Licenses, services and clinical supply   3,967   6,922   17,045   16,230
Total revenue   369,657   213,634   955,543   472,632

Revenue from Commercial Products
(In EUR’000s)
  Three Months Ended
September 30,
  Nine Months Ended
September 30,
    2026   2025   2026   2025
Revenue from commercial products
YORVIPATH®   290,626   143,089   739,634   290,735
SKYTROFA®   59,424   50,701   158,595   152,745
YUVIWEL®   15,640   —   23,223   —
Total revenue from commercial products   365,690   193,790   921,452   443,480
 

Research and development expenses for the third quarter of 2026 were €70 million, compared to €67 million during the same period in 2025. The increase was due to increased clinical trial activities within the Endocrinology Rare Disease pipeline, partially offset by reduced clinical trial activities within Oncology.

Selling, general, and administrative expenses for the third quarter of 2026 were €147 million, compared to €113 million during the same period in 2025. The increase was primarily due to the continued commercial expansion, including global launch activities.

Total operating expenses for the third quarter of 2026 were €217 million, compared to €180 million during the same period in 2025.

Operating profit for the third quarter of 2026 was €125 million, reflecting a margin of 34%, compared to €11 million, reflecting a margin of 5% during the same period in 2025. The increase was primarily driven by higher revenue from the continued growth of YORVIPATH global sales, partially offset by higher operating expenses associated with global commercial expansion.

Net finance expenses for the third quarter of 2026 were €4 million, compared to €61 million in the same period in 2025. The change was primarily driven by non-cash items.

Net profit for the third quarter of 2026 was €74 million, or €1.13 per basic share and €1.08 per diluted share, compared to a net loss of €61 million, or €1.00 per basic and diluted share, for the same period in 2025.

Cash flows from operating activities for the nine months ended September 30, 2026, were €463 million compared to €20 million used in operating activities during the same period in 2025. The improvement was primarily attributable to commercial revenue growth and net proceeds from the sale of the PRV of €158 million (net of transaction costs), partially offset by less favorable changes in working capital of approximately €15 million and higher interest and income taxes paid.

As of September 30, 2026, Ascendis Pharma had 66,400,738 ordinary shares outstanding, of which 805,528 were held as treasury shares.

For the third quarter of 2026, non-IFRS operating profit was €156 million*, compared to a non-IFRS operating profit of €42 million* for the same period in 2025.

For the third quarter of 2026, non-IFRS net profit was €117 million*, or €1.71 earnings per diluted share*, compared to a non-IFRS net profit of €24 million*, or €0.40 earnings per diluted share*, for the same period in 2025.

Conference Call and Webcast Information
Ascendis Pharma will host a conference call and webcast today at 8:00 a.m. Eastern Time (ET) to discuss its third quarter 2026 financial results. Those who would like to participate may access the live webcast here, or register in advance for the teleconference here. The link to the live webcast will also be available on the Investors & News section of the Ascendis Pharma website at https://investors.ascendispharma.com. A replay of the webcast will be available in this section of the Ascendis Pharma website shortly after the conclusion of the event for 30 days.

About Ascendis Pharma A/S
Ascendis Pharma is a global biopharmaceutical company focused on applying our innovative TransCon technology platform to make a meaningful difference for patients. Guided by our core values of Patients, Science, and Passion, and following our algorithm for product innovation, we apply TransCon to develop new therapies that demonstrate best-in-class potential to address unmet medical needs. Ascendis is headquartered in Copenhagen, Denmark, and has additional facilities in Europe and the United States. Please visit ascendispharma.com to learn more.

Forward-Looking Statements
This press release contains forward-looking statements that involve substantial risks and uncertainties. All statements, other than statements of historical facts, included in this press release regarding Ascendis’ future operations, results, plans and objectives of management are 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. Examples of such statements include, but are not limited to, statements relating to (i) anticipated timing of regulatory decisions and potential product launches, (ii) anticipated timing and plans of clinical trials and development activities, including expected timing of patient recruitment, trial initiation, completion of enrollment and availability of topline data, (iii) Ascendis’ ability to apply its TransCon technology platform to make a meaningful difference for patients, (iv) Ascendis’ use of TransCon to create new and potentially best-in-class therapies, (v) plans for regulatory filings, label expansions, new country launches and early access programs, (vi) expectations regarding continued patient demand, product uptake, reimbursement coverage, revenue from markets outside the U.S. and EU, future growth and market positioning, and (vii) Ascendis’ capital allocation, including share repurchases, and obligations under its commercial agreements. Ascendis may not actually achieve the plans, carry out the intentions or meet the expectations or projections disclosed in the forward-looking statements and you should not place undue reliance on these forward-looking statements. Actual results or events could differ materially from the plans, intentions, expectations and projections disclosed in the forward-looking statements. Various important factors could cause actual results or events to differ materially from the forward-looking statements that Ascendis makes, including, without limitation: dependence on third party manufacturers, distributors, and service providers for Ascendis’ products and product candidates; risks related to regulatory review and approval, including the possibility of delays, requests for additional data or analyses, restrictions or limitations on use, approval with labeling that is more limited than expected, or failure to obtain approval in the United States, European Union, or other jurisdictions; clinical development risks, including that results from ongoing or future trials may not confirm earlier data; unforeseen safety or efficacy findings in development programs or on market products; manufacturing, supply chain, quality, or logistics issues that could delay development or commercialization; unforeseen expenses related to commercialization of any approved Ascendis products; unforeseen research and development or selling, general and administrative expenses and other costs impacting Ascendis’ business generally; market acceptance, pricing, and reimbursement challenges, including payer coverage decisions and health technology assessments; competitive developments, including new or improved therapies; intellectual property protection, freedom-to-operate, and litigation risks; Ascendis’ ability to obtain additional funding, if needed, to support its business activities; cybersecurity, data privacy, and information technology disruptions; and the impact of international economic, political, legal, compliance, public health, and business factors, including tariffs, trade policies, currency fluctuations, and geopolitical events. For a further description of the risks and uncertainties that could cause actual results to differ from those expressed in these forward-looking statements, as well as risks relating to Ascendis’ business in general, see Ascendis’ Annual Report on Form 20-F filed with the U.S. Securities and Exchange Commission (SEC) on February 11, 2026, and Ascendis’ other future reports filed with, or submitted to, the SEC. Forward-looking statements do not reflect the potential impact of any future licensing, collaborations, acquisitions, mergers, dispositions, joint ventures, or investments that Ascendis may enter into or make. Ascendis does not assume any obligation to update any forward-looking statements, except as required by law.

Ascendis, Ascendis Pharma, the Ascendis Pharma logo, the company logo, TransCon, SKYTROFA®, YORVIPATH®, and YUVIWEL® are trademarks owned by the Ascendis Pharma group. © November 2026 Ascendis Pharma A/S.

Investor Contact: Media Contact:
Chad Fugere Melinda Baker
Ascendis Pharma Ascendis Pharma
+1 (650) 519-7494 +1 (650) 709-8875
 

FINANCIAL TABLES FOLLOW

Ascendis Pharma A/S
Unaudited Condensed Consolidated Statements of Profit or (Loss) and Comprehensive Income / (Loss)
(In EUR’000s, except per share data)
  Three Months Ended
September 30,
  Nine Months Ended
September 30,
    2026   2025   2026   2025
Consolidated Statement of Profit or (Loss)
Revenue   369,657     213,634     955,543     472,632  
Cost of sales   (28,311 )   (22,354 )   (73,484 )   (71,317 )
Gross profit   341,346     191,280     882,059     401,315  
Research and development expenses   (69,925 )   (66,879 )   (204,857 )   (225,470 )
Selling, general, and administrative expenses   (146,845 )   (113,404 )   (465,416 )   (322,012 )
Total operating expenses   (216,770 )   (180,283 )   (670,273 )   (547,482 )
Other operating income   —     —     158,067     —  
Operating profit/(loss)   124,576     10,997     369,853     (146,167 )
Share of profit/(loss) of associates   (6,868 )   (7,501 )   (13,283 )   14,980  
Finance income   7,706     6,036     16,998     89,948  
Finance expenses   (12,043 )   (66,904 )   (78,280 )   (144,707 )
Profit/(loss) before tax   113,371     (57,372 )   295,288     (185,946 )
Income taxes (expenses)   (39,398 )   (3,617 )   614,995     (8,526 )
Net profit/(loss) for the period   73,973     (60,989 )   910,283     (194,472 )
Attributable to owners of the Company   73,973     (60,989 )   910,283     (194,472 )
Basic earnings/(loss) per share   1.13     (1.00 )   14.24     (3.22 )
Diluted earnings/(loss) per share   1.08     (1.00 )   13.63     (3.22 )
 
 
Consolidated Statement of Comprehensive Income or (Loss)
Net profit/(loss) for the period   73,973     (60,989 )   910,283     (194,472 )
Other comprehensive income/(loss)
Items that may be reclassified subsequently to profit or (loss):
Exchange differences on translating foreign operations   3,383     (1,574 )   11,299     (3,048 )
Other comprehensive income/(loss) for the period, net of tax   3,383     (1,574 )   11,299     (3,048 )
Total comprehensive income/(loss) for the period, net of tax   77,356     (62,563 )   921,582     (197,520 )
Attributable to owners of the Company   77,356     (62,563 )   921,582     (197,520 )

Ascendis Pharma A/S
Unaudited Condensed Consolidated Statements of Financial Position
(In EUR’000s)
  September 30,
2026
  December 31,
2025
Assets
Non-current assets
Intangible assets   3,657   3,710  
Property, plant and equipment   134,935   146,479  
Investments in associates   24,107   32,526  
Other receivables   25,640   10,870  
Deferred tax assets   651,891   —  
    840,230   193,585  
Current assets
Inventories   331,347   301,533  
Trade receivables   225,839   141,333  
Income tax receivables   11,893   1,781  
Other receivables   16,684   14,582  
Prepayments   36,827   33,715  
Cash and cash equivalents   964,364   616,041  
    1,586,954   1,108,985  
Total assets   2,427,184   1,302,570  
 
Equity and liabilities
Equity
Share capital   8,914   8,322  
Distributable equity   1,491,537   (171,143 )
Total equity   1,500,451   (162,821 )
 
Non-current liabilities
Borrowings   377,653   385,254  
Contract liabilities   —   1,123  
Deferred tax liabilities   —   9,623  
    377,653   396,000  
Current liabilities
Convertible notes
Borrowings   —   429,391  
Derivative liabilities   —   256,231  
    —   685,622  
Other current liabilities
Borrowings   70,152   57,141  
Contract liabilities   3,893   4,944  
Trade payables and accrued expenses   109,716   90,657  
Other liabilities   87,518   58,204  
Income tax payables   12,635   6,427  
Provisions   265,166   166,396  
    549,080   383,769  
Total current liabilities   549,080   1,069,391  
Total liabilities   926,733   1,465,391  
Total equity and liabilities   2,427,184   1,302,570  

Ascendis Pharma A/S
Unaudited Condensed Consolidated Statements of Cash Flows
(In EUR’000s)
  Nine Months Ended
September 30,
    2026   2025
Operating activities
Net profit/(loss) for the period   910,283     (194,472 )
Reversal of finance income   (16,998 )   (89,948 )
Reversal of finance expenses   78,280     144,707  
Reversal of (gain)/loss on disposal of property, plant and equipment   21     —  
Reversal of income taxes   (614,995 )   8,526  
Adjustments for non-cash items:
Non-cash consideration relating to revenue   (3,581 )   (3,002 )
Share of (profit)/loss of associates   13,283     (14,980 )
Share-based payment   91,110     86,216  
Depreciation and amortization   13,431     12,872  
Impairment of property, plant and equipment   —     7,508  
Changes in working capital:
Inventories   (29,819 )   (6,421 )
Receivables   (79,363 )   25,138  
Prepayments   (2,839 )   (1,730 )
Contract liabilities   (2,174 )   (1,084 )
Trade payables, accrued expenses and other liabilities   36,408     (33,088 )
Provisions   93,441     48,288  
Cash flows generated from/(used in) operations   486,488     (11,470 )
Finance income received   16,997     10,929  
Finance expenses paid   (24,418 )   (12,652 )
Income taxes received/(paid)   (16,313 )   (6,308 )
Cash flows from/(used in) operating activities   462,754     (19,501 )
Investing activities
Payments received under finance leases   2,003     —  
Acquisition of intangible assets and property, plant and equipment   (13,711 )   (5,094 )
Cash flows from/(used in) investing activities   (11,708 )   (5,094 )
Financing activities
Repayment of borrowings   (25,746 )   (15,124 )
Proceeds from exercise of warrants   73,069     71,727  
Costs of capital increase   (125 )   —  
Acquisition of treasury shares   (155,843 )   (17,396 )
Payment of withholding taxes under stock incentive programs   (12,781 )   (11,396 )
Cash flows from/(used in) financing activities   (121,426 )   27,811  
 
Increase/(decrease) in cash and cash equivalents   329,620     3,216  
Cash and cash equivalents at January 1   616,041     559,543  
Effect of exchange rate changes on balances held in foreign currencies   18,703     (23,667 )
Cash and cash equivalents at September 30   964,364     539,092  
 

Non-IFRS Financial Measures

In addition to the financial information prepared in accordance with IFRS Accounting Standards (“IFRS”) as issued by the International Accounting Standards Board and as adopted by the European Union, this press release contains certain non-IFRS financial measures, including Non-IFRS Operating Profit/(Loss), Non-IFRS Net Profit/(Loss), Non-IFRS operating profit/(loss) margin, and Non-IFRS diluted earnings per share (“Non-IFRS Diluted EPS”). These non-IFRS measures are provided as supplemental information and should be considered in addition to, and not as a substitute for or superior to, the comparable measures prepared in accordance with IFRS. Management believes these non-IFRS measures support management’s, analysts’ and investors’ overall understanding of the Company’s underlying financial performance and trends and facilitate comparisons among current and past periods.

Since non-IFRS measures do not have standardized definitions and meanings, they may differ from the non-IFRS measures used by other companies, which reduces their usefulness as comparative financial measures. Because of these limitations, you should consider these adjusted financial measures alongside other IFRS financial measures. Because these non-IFRS measures are not prepared in accordance with IFRS, they should not be viewed as superior to IFRS reported measures, nor should they be used on their own or as replacements for the IFRS financial information included in this press release. Additionally, our non-IFRS measures may differ from similarly labeled measures used by other companies due to variations in calculation methods or the size and nature of adjusted items. Investors should note that several of the items excluded from these non-IFRS measures have been recognized in prior periods and may continue to be recognized in future periods.

The Company reports Non-IFRS Operating Profit/(Loss), Non-IFRS Net Profit/(Loss), Non-IFRS operating profit/(loss) margin and Non-IFRS Diluted EPS as non-IFRS measures, which exclude the following specified items:

(i) Share-based compensation costs. Although share-based compensation is a recurring expense, the Company excludes it from non-IFRS measures because the amount and timing of recognition depend on the value of the underlying equity instruments, which can fluctuate based on factors unrelated to the Company’s operating performance during the period.

(ii) Other operating income from sale of PRV. The Company excludes income recognized from the sale of its PRV because it does not reflect the Company’s ongoing operating activities.

(iii) Share of (profit)/loss of associates. The Company excludes its share of the profit or loss of equity-method investees because these amounts are not within the control of the Company and do not reflect the Company’s core operating performance.

(iv) Remeasurement (gain)/loss of derivative liabilities. The Company excludes the fair-value remeasurement of derivative liabilities associated with its convertible notes because these amounts depend on movements in the Company’s share price and other market inputs and are not indicative of the Company’s underlying operating performance.

(v) Remeasurement (gain)/loss of royalty funding liabilities. The Company excludes gains and losses arising from the remeasurement of royalty funding liabilities as these amounts are driven by changes in estimates of future royalty payment obligations under the Company’s royalty funding agreements and do not reflect the Company’s underlying operating performance.

(vi) Recognition of previously unrecognized deferred tax assets and prior-period tax adjustments. The Company excludes the recognition of previously unrecognized deferred tax assets, and current and deferred tax adjustments relating to prior periods because these items reflect a reassessment of the recoverability of historical tax attributes or adjustments of prior-period tax positions rather than the Company’s current period operating performance.

Income taxes related to the foregoing items are adjusted accordingly, considering the individual impact of each item, the relevant tax jurisdiction, applicable tax rates, and the deductibility of the item.

For further details regarding valuation of derivative liabilities, and the recognition of previously unrecognized deferred tax assets, please refer to “Note 3 – Significant Accounting Judgments and Estimates,” and “Note 11 – Financial Assets and Liabilities,” contained in our Interim Report on Form 6-K for the period ended September 30, 2026, and “Note 3 – Significant Accounting Judgments and Estimates,” contained in our Annual Report on Form 20-F for the year ended December 31, 2025.

The following table provides a reconciliation of the most directly comparable IFRS measures to Non-IFRS Operating Profit/(Loss), Non-IFRS operating profit/(loss) margin, Non-IFRS Net Profit/(Loss) and Non-IFRS Diluted EPS.

Reconciliation of unaudited IFRS to Non-IFRS Financial Information
(In EUR’000s, except number of shares and per share data)
 
    Three Months Ended
September 30,
  Nine Months Ended
September 30,
    2026   2025   2026   2025
IFRS operating profit/(loss)   124,576     10,997     369,853     (146,167 )
Share-based compensation costs   31,146     30,636     91,110     86,216  
Other operating income from sale of PRV   —     —     (158,067 )   —  
Total non-IFRS adjustments to operating profit/(loss)   31,146     30,636     (66,957 )   86,216  
Non-IFRS operating profit/(loss)   155,722     41,633     302,896     (59,951 )
 
IFRS operating profit/(loss) margin (%)1   33.7 %   5.1 %   38.7 %   (30.9 %)
Non-IFRS operating profit/(loss) margin (%)1   42.1 %   19.5 %   31.7 %   (12.7 %)
 
 
IFRS Net profit/(loss)   73,973     (60,989 )   910,283     (194,472 )
Share-based compensation costs   31,146     30,636     91,110     86,216  
Other operating income from sale of PRV   —     —     (158,067 )   —  
Share of (profit)/loss of associates   6,868     7,501     13,283     (14,980 )
Remeasurement (gain)/loss of derivative liabilities   —     47,183     25,938     83,091  
Remeasurement (gain)/loss of royalty funding liabilities   —     —     —     (1,398 )
Recognition of previously unrecognized deferred tax assets and prior-period tax adjustments   9,304     20     (696,115 )   11  
Tax effects of adjustments   (4,048 )   —     22,779     —  
Total non-IFRS adjustments to net profit/(loss)   43,270     85,340     (701,072 )   152,940  
Non-IFRS net profit/(loss)   117,243     24,351     209,211     (41,532 )
 
Net profit/(loss) per diluted share:
IFRS   1.08     (1.00 )   13.63     (3.22 )
Diluted per share impact of total non-IFRS adjustments   0.63     1.40     (10.50 )   2.53  
Non-IFRS   1.71     0.40     3.13     (0.69 )
 
Shares used in diluted per share calculation (IFRS and non-IFRS):   68,709,423     60,756,015     66,781,342     60,412,419  

1Defined as either IFRS or non-IFRS operating profit/(loss) divided by total revenue.

Roadmap defines milestones for physical qubits, logical qubits and gate performance, targeting ~800 logical qubits and 100,000+ physical qubits by 2030

TEL AVIV, Israel, Nov. 12, 2026 (GLOBE NEWSWIRE) — Quantum X Labs Inc. (NASDAQ: QXL) (“Quantum X Labs” or the “Company”), a quantum technology company developing quantum computing, quantum sensing, quantum error correction and quantum applications technologies, today announced the publication of its cold-atom quantum computing roadmap. The roadmap outlines the Company’s planned progression from its current physical-qubit platform toward error-corrected and, ultimately, fault-tolerant quantum computing, which the Company is targeting by 2030.

The roadmap reflects the Company’s progress to date and defines each milestone in terms of physical qubits, logical qubits and gate performance, so that progress can be tracked against measurable targets. The Company believes these metrics, rather than raw physical-qubit counts alone, will determine when quantum computers become commercially useful. The roadmap is anchored in the Company’s cold-atom laboratory, which, based on information available to the Company, the Company believes is among the largest cold-atom laboratories in Israel.

In 2026, the Company achieved more than 50 physical qubits on its cold-atom platform. On its decoder performance, the Company recently evaluated the logical error rate of its quantum error-correction decoder on Google’s publicly available surface-code hardware dataset and on surface-code simulations, using NVIDIA CUDA-Q QEC as the test environment. In that evaluation, the Company’s decoder achieved the lowest logical error rates in comparison to the other decoders it was benchmarked against.

The roadmap in detail (all figures are targets and are subject to the risks and uncertainties described below):

Year Goal Logical qubits Physical qubits Gate performance
2027 Towards logical quantum computing Up to 20 1,000+ N/A
2029 Error-corrected computing ~100 10,000+ 99.9%
2030 Full fault-tolerant scale-up ~800 100,000+ 99.999999%

“A quantum computer is measured by how many reliable logical qubits it can deliver,” said Prof. Nir Sharon, Chief Quantum Scientist of Quantum X Labs. “That is why every milestone in this roadmap is defined by physical qubits, logical qubits and gate performance together. We have designed our cold-atom platform and our AI-based decoder to work as one system, and we intend to be measured against these targets as we work to move from today’s architecture toward error-corrected computing.”

The Company intends to pursue the roadmap by integrating its patent (pending) deep transformer decoder (U.S. Patent No. 12,294,387 B2), an AI-based error-correction system coupled with its cold-atom control stack as it seeks to scale from physical to logical qubits. The Company expects to report on its progress against these milestones in its periodic filings with the SEC and in its press releases, as appropriate.

About Quantum X Labs Inc.

Quantum X Labs Inc. and its subsidiaries are focused on quantum technology, digital advertising and computing and enterprise artificial intelligence (AI) solutions. Quantum X Labs Ltd. is focused on developing and promoting quantum algorithms for the transportation, drug discovery and security segments as well as developing quantum- based GPS replacement and quantum atom accuracy solutions. Gix Media develops a variety of technological software solutions, which perform automation, optimization and monetization of internet campaigns, for the purposes of acquiring and routing internet user traffic to its customers. Metagramm is a developer of grammatical error correction software and offers tools for writing and reviewing, grammar, spelling, punctuation and style features, as well as translation and multilingual dictionaries, using artificial intelligence and machine learning technology.

For more information about Quantum X Labs, visit https://quantumxlabs.xyz/

Forward-Looking Statements

This press release contains forward-looking statements within the meaning of the “safe harbor” provisions of the Private Securities Litigation Reform Act of 1995 and other Federal securities laws. Forward-looking statements contained in this press release include, but are not limited to, statements regarding Quantum X Labs’ and its subsidiaries’ strategic and business plans, technology, relationships, objectives and expectations for its business, growth, the impact of trends on and interest in its business, intellectual property, products and its future results, operations and financial performance and condition and may be identified by the use of words such as “may,” “seek,” “will,” “consider,” “likely,” “assume,” “estimate,” “expect,” “anticipate,” “intend,” “believe,” “do not believe,” “aim,” “predict,” “plan,” “project,” “continue,” “potential,” “guidance,” “objective,” “outlook,” “trends,” “future,” “could,” “would,” “should,” “target,” “roadmap,” “milestone,” “on track” or their negatives or variations, and similar terminology and words of similar import, generally involve future or forward-looking statements. For example, the Company is using forward-looking statements when it discusses its cold-atom quantum computing roadmap, including its targeted milestones for physical qubits, logical qubits and gate performance in 2027, 2029 and 2030 and its goal of achieving fault-tolerant quantum computing by 2030; its belief regarding the metrics that will determine when quantum computers become commercially useful; the expected performance, scalability and integration of its AI-based quantum error-correction decoder with its cold-atom control stack; and its intention to report progress against these milestones. Achievement of these milestones depends on, among other things, scientific and engineering breakthroughs that have not yet been demonstrated, the Company’s ability to obtain sufficient funding and to recruit and retain qualified personnel, the availability of components and facilities, and competition, and the milestones may be delayed, modified or not achieved at all. Forward-looking statements are not historical facts, and are based upon management’s current expectations, beliefs and projections, many of which, by their nature, are inherently uncertain. Such expectations, beliefs and projections are expressed in good faith. However, there can be no assurance that management’s expectations, beliefs and projections will be achieved, and actual results may differ materially from what is expressed in or indicated by the forward-looking statements. Forward-looking statements are subject to risks and uncertainties that could cause actual performance or results to differ materially from those expressed in the forward-looking statements. For a more detailed description of the risks and uncertainties affecting the Company, reference is made to the Company’s reports filed from time to time with the Securities and Exchange Commission (“SEC”), including, but not limited to, the risks detailed in the Company’s most recent Annual Report on Form 10-K and in subsequent filings with the SEC. Forward-looking statements speak only as of the date the statements are made. The Company assumes no obligation to update forward-looking statements to reflect actual results, subsequent events or circumstances, changes in assumptions or changes in other factors affecting forward-looking information except to the extent required by applicable securities laws. If the Company does update one or more forward-looking statements, no inference should be drawn that the Company will make additional updates with respect thereto or with respect to other forward-looking statements. References and links to websites have been provided as a convenience, and the information contained on such websites is not incorporated by reference into this press release. Quantum X Labs is not responsible for the content of third-party websites. Google is a trademark of Google LLC. NVIDIA and CUDA-Q are trademarks or registered trademarks of NVIDIA Corporation in the U.S. and other countries. Use of these names does not imply any affiliation with, or endorsement by, Google LLC or NVIDIA Corporation.

Investor Relations Contacts:

Michal Efraty
Investor Relations
michal@efraty.com 

GB-0895 is being evaluated in two Phase 3 severe asthma studies for dosing twice a year

A single dose of GB-0895 produced sustained pharmacological activity for at least six months in COPD

Zealand Pharma collaboration provides $30 million upfront, $35 million in early preclinical milestones and nearly $1.2 billion in total potential milestones, plus tiered royalties

Anthropic collaboration builds on AI agent–guided CAR T research yielding smaller signaling domains with improved function in preclinical studies

Oncology clinical programs advance with second-cohort enrollment for GB-4362 in advanced urothelial cancer and first-patient dosing of GB-5267 in platinum-resistant ovarian cancer

Cash, cash equivalents, and marketable securities of $404.2 million as of Sept. 30, 2026

SOMERVILLE, Mass., Nov. 12, 2026 (GLOBE NEWSWIRE) — Generate Biomedicines, Inc. (Nasdaq: GENB) (“Generate”) today reported financial results for the third quarter ended Sept. 30, 2026, and provided an update on recent business progress.

“Our third quarter results reflect both strong execution across all of our clinical programs and our continued efforts to push the frontiers of programmable biology and therapeutic intelligence,” said Mike Nally, chief executive officer of Generate Biomedicines. “We are making strong progress with GB-0895 in severe asthma, and the data we shared at ERS in COPD further demonstrated the sustained pharmacological activity to support robust modulation of key biomarkers and twice-a-year dosing. At the same time, our scientists are extending the impact of our platform, from new CAR T engineering to our collaboration with Anthropic on agentic science. We start with what a therapy needs to do, then engineer and test the biology to get there.”

Recent Progress

GB-0895 in severe asthma and COPD

GB-0895, Generate’s most advanced internal drug candidate, is an investigational anti-TSLP monoclonal antibody engineered with AI for dosing twice a year. The two global Phase 3 SOLAIRIA studies are ongoing in adults and adolescents with severe uncontrolled asthma, and recent Phase 1b results in COPD patients highlight an opportunity to expand into a large and underserved patient population.

Generate presented three posters on GB-0895 at the European Respiratory Society Congress, held Sept. 5–9, 2026, in Barcelona, Spain.

  • Phase 1 asthma findings. Complete Phase 1 findings showed that a single dose of GB-0895 sustained inflammatory biomarker reductions for at least six months in participants with mild-to-moderate asthma. At 300 mg, GB-0895 achieved maximal biomarker suppression and had a half-life of approximately 98 days, supporting the dosing interval being evaluated in Phase 3.
  • Phase 1b COPD findings. A single dose of GB-0895 sustained inflammatory biomarker reductions for at least six months in participants with COPD. Comparable suppression was demonstrated for 300 mg and 600 mg, extending the evidence supporting six-month pharmacological activity to a second respiratory indication.
  • SOLAIRIA Phase 3 study design. The study-design poster detailed the ongoing SOLAIRIA-1 and SOLAIRIA-2 trials in adults and adolescents with severe uncontrolled asthma. The replicate trials evaluate 300 mg administered every 26 weeks, with annualized asthma exacerbation rate over 52 weeks as the primary endpoint.

Zealand Pharma collaboration in obesity and metabolic diseases

On Oct. 13, Generate and Zealand Pharma announced a collaboration and license agreement providing Generate with $30 million upfront and up to $35 million in early preclinical milestones within nearly $1.2 billion in total potential milestone payments, plus tiered royalties on future worldwide net sales of any commercialized products.

The agreement covers two initial programs to develop multispecific protein therapeutics for obesity and other metabolic diseases, with an option to add a third for additional financial consideration. Generate will lead research through lead-candidate selection. Zealand will assume responsibility for subsequent preclinical and clinical development, regulatory submissions, and worldwide commercialization.

Anthropic collaboration and AI-driven CAR T-cell research

On Oct. 27, Generate and Anthropic announced a research collaboration to explore a novel application of an agentic approach to advance next-generation CAR T-cell research.

In early preclinical research, a team of six Generate scientists combined AI agents with the company’s computational and experimental capabilities over approximately six months to engineer a CAR signaling domain approximately 70% shorter than the second-generation design used for comparison. In laboratory tests, CAR T cells incorporating the compact domain showed improved tumor-cell killing compared with the comparison design.

The research also supported expression of four different CARs from a shared mRNA dose, suggesting potential applications in designs targeting multiple tumor antigens. The collaboration focuses on selecting and validating antigen combinations for early-stage solid tumors.

Oncology pipeline advances

GB-4362 aims to address treatment-limiting toxicities associated with antibody-drug conjugates, while GB-5267 is designed to address the difficulty of sustaining CAR T-cell activity in solid tumors.

  • GB-4362 advanced to the second of potentially three dose-escalation cohorts. Enrollment has begun in the second cohort of the Phase 1 study evaluating GB-4362 with enfortumab vedotin and pembrolizumab in advanced urothelial cancer.
  • On Oct. 23, Generate presented a trial-in-progress poster describing the Phase 1 clinical study design of GB-4362 at the 2026 European Society for Medical Oncology Congress in Madrid.
  • On Oct. 1, Generate and Roswell Park Comprehensive Cancer Center announced that the first patient had been dosed in the Phase 1 study of the investigational autologous IL-18-armored CAR T-cell therapy in platinum-resistant ovarian cancer. GB-5267 targets MUC16, an antigen overexpressed in more than 80% of ovarian tumors, and was engineered with AI to optimize tumor-cell killing, T-cell expansion, and persistence. The trial begins the clinical evaluation of that function-first design without requiring chemotherapy-based lymphodepletion.
  • On Oct. 18, Roswell Park delivered an oral presentation at the 16th Biennial Rivkin Ovarian Cancer Research Symposium in Philadelphia detailing the scientific rationale and study design. The presentation highlighted IL-18 armoring intended to support CAR T-cell activity and a Phase 1 study evaluating GB-5267 without chemotherapy-based lymphodepletion

“We continue to advance GB-0895 through the Phase 3 SOLAIRIA studies in severe asthma and make progress across our clinical pipeline. Following the quarter-end, we also entered into a new collaboration agreement with Zealand Pharma,” said Jason Silvers, president and chief financial officer of Generate Biomedicines. “Dosing is underway in cohort 2 of GB-4362, and our first patient has been dosed in the GB-5267 study with Roswell Park. Under the Zealand agreement, Generate received a $30 million upfront payment in October, may receive additional near-term milestones, and is now partnered to explore multispecific protein therapeutics for obesity and metabolic disease. We plan to continue pursuing partnerships that apply our platform to new therapeutic areas, advance differentiated medicines, and provide non-equity-dilutive capital to support our internal programs.”

Financial Results

Cash, cash equivalents, and marketable securities were $404.2 million as of Sept. 30, 2026, compared with $457.4 million as of June 30, 2026. Generate believes its existing cash, cash equivalents, and marketable securities, together with the $30.0 million upfront payment received from Zealand in October 2026 in connection with the Zealand collaboration, will be sufficient to fund its current operating plan into the first half of 2028. Generate expects to require additional capital to support long-term operations.

Revenue for the quarter ended Sept. 30, 2026, was $4.2 million, compared with $9.6 million for the same period in 2025. This revenue reflects developments in the ongoing Amgen and Novartis research programs and that Generate is near completion of its performance obligations under both agreements.

Research and development expenses were $82.3 million for the quarter ended Sept. 30, 2026, compared with $62.2 million for the same period in 2025. The increase was driven primarily by continued investment in the GB-0895 Phase 3 SOLAIRIA clinical trials in severe asthma and was partially offset by a decrease in external discovery and other program related costs.

General and administrative expenses were $13.5 million for the quarter ended Sept. 30, 2026, compared with $10.3 million for the same period in 2025. The increase was driven primarily by an increase in stock-based compensation.

Net loss was $87.7 million for the quarter ended Sept. 30, 2026, compared with $60.0 million for the same period in 2025. These amounts include noncash stock-based compensation expense of $8.1 million and $4.8 million, respectively.

About Generate Biomedicines

Generate (Nasdaq: GENB) is a clinical-stage generative biology company founded at the intersection of machine learning, biological engineering, and medicine, advancing a new era of programmable biology to engineer better drug candidates for patients, faster. The Generate Platform integrates computational design with large-scale biological experimentation, enabling the creation of novel, optimized therapeutics that address historically undruggable and hard-to-drug targets, as well as known targets in new and more effective ways. The platform has enabled the generation of a broad pipeline across multiple therapeutic areas and protein-based modalities, addressing health challenges out of reach of traditional approaches. Founded in 2018, Generate is leading a fundamental shift from drug discovery to drug generation. Learn more at www.generatebiomedicines.com or follow us on X, LinkedIn, and YouTube.

Digital Media Disclosure

From time to time Generate has used, or expects in the future to use, its investor website (investors.generatebiomedicines.com), the Generate LinkedIn account (linkedin.com/company/generate-biomedicines), and the Generate X account (@generate_biomed) as means of disclosing information to the public in a broad, nonexclusionary manner, including for purposes of the SEC’s Regulation Fair Disclosure (Reg FD). Accordingly, investors should monitor the investor website and these social media channels in addition to news releases, SEC filings, public conference calls, and webcasts, as the information posted on them could be material to investors.

Cautionary Note Regarding Forward-Looking Statements

This news release contains “forward-looking statements” within the meaning of the Private Securities Litigation Reform Act of 1995. All statements contained in this news release that do not relate to matters of historical fact should be considered forward-looking statements, including, without limitation, statements regarding the advancement of Generate’s drug candidates; the initiation, design, conduct, timing, progress, and results of preclinical studies and clinical trials, including SOLAIRIA-1 and SOLAIRIA-2 and the Phase 1 studies of GB-5267 and GB-4362; the potential benefits of GB-0895 and dosing twice a year; the likelihood and timing of a decision to proceed with development of GB-0895 in COPD; the scope and potential benefits of the collaboration with Zealand, including the design and development of multispecific protein therapeutics, the potential addition of a third program, and the potential milestone payments and royalties; the scope and potential benefits of the research collaboration with Anthropic, including the application of agentic methods to target selection and validation and further development of redesigned CAR signaling domains; Generate’s expected cash runway; and the expected enhancements, benefits, and potential of The Generate Platform.

In some cases, forward-looking statements can be identified by terms such as “may,” “will,” “should,” “would,” “expect,” “plan,” “anticipate,” “could,” “intend,” “target,” “project,” “believe,” “estimate,” “predict,” “potential,” or “continue,” or the negative of these terms or other similar expressions.

These forward-looking statements are based on management’s current expectations and beliefs and are subject to a number of risks, uncertainties, and assumptions that could cause actual results to differ materially from those described in the forward-looking statements, including, but not limited to, risks and uncertainties related to Generate’s ability to successfully develop and obtain regulatory approval for its drug candidates; the initiation, design, progress, timing, and results of preclinical studies and clinical trials; Generate’s ability to obtain, maintain, and enforce intellectual property protection; Generate’s dependence on third parties for the manufacturing and development of its drug candidates; Generate’s ability to realize the intended benefits of collaborations with third parties; the impact of competitive products and technologies; Generate’s ability to replicate results from earlier preclinical studies or clinical trials in current or future clinical trials; Generate’s ability to demonstrate that its drug candidates are safe and effective for their proposed indications; Generate’s ability to obtain additional capital to fund its operations; and general economic, industry, and market conditions.

Additional information on these and other risks and uncertainties that could affect Generate’s business, financial condition, and results of operations is included in Generate’s filings with the Securities and Exchange Commission, including its Quarterly Reports. The forward-looking statements in this news release are made as of the date hereof, and Generate undertakes no obligation to update any forward-looking statements to reflect events or circumstances after the date of this news release, except as required by applicable law.

Generate Media Contact

Megan McLaughlin
pr@generatebiomedicines.com

GENERATE BIOMEDICINES, INC. AND SUBSIDIARIES
CONDENSED CONSOLIDATED BALANCE SHEETS
(in thousands, except share and per share data) (unaudited)
             
    As of September 30,     As of December 31,  
    2026     2025  
Assets            
Current assets:            
Cash and cash equivalents   $ 140,350     $ 121,650  
Marketable securities     263,862       99,848  
Restricted cash and cash equivalents (VIE)     —       339  
Prepaid expenses and other current assets     10,429       12,528  
Total current assets     414,641       234,365  
Property and equipment, net     38,653       29,151  
Operating lease right-of-use assets     53,255       59,860  
Other assets     9,341       6,806  
Total assets   $ 515,890     $ 330,182  
Liabilities, convertible preferred stock, non-controlling interest and stockholders’ deficit            
Current liabilities:            
Accounts payable(1)   $ 7,892     $ 3,837  
Accrued expenses and other current liabilities     43,554       42,164  
Deferred revenue – current     7,947       21,194  
Current portion of finance lease liabilities     12,499       4,311  
Operating lease liabilities – current     10,830       10,697  
Total current liabilities     82,722       82,203  
Non-current liabilities:            
Warrant to purchase convertible preferred stock     —       1,205  
Non-current portion of finance lease liabilities     5,891       2,908  
Deferred revenue – non-current     —       4,511  
Operating lease liabilities – non-current     46,121       50,610  
Other long term liabilities     —       116  
Total liabilities     134,734       141,553  
Commitments and contingencies (Note 13)            
Convertible preferred stock     —       811,826  
Non-controlling interest     —       (7,232 )
Stockholders’ equity (deficit):            
Common stock, par value $0.001; 500,000,000 and 200,456,735 shares authorized as of September 30, 2026 and December 31, 2025 respectively; 129,021,869 and 33,116,957 shares issued and outstanding as of September 30, 2026 and December 31, 2025, respectively     129       33  
Additional paid-in capital     1,273,942       60,189  
Accumulated other comprehensive (loss) income     (264 )     106  
Accumulated deficit     (892,651 )     (676,293 )
Total stockholders’ equity (deficit)     381,156       (615,965 )
Total liabilities, convertible preferred stock, non-controlling
interests and stockholders’ equity (deficit)
  $ 515,890     $ 330,182  

(1) Includes related party amounts of $0.1 million as of September 30, 2026, and $0.2 million as of December 31, 2025. See Note 14 for details of related party amounts.
   

GENERATE BIOMEDICINES, INC. AND SUBSIDIARIES
CONDENSED CONSOLIDATED STATEMENTS OF OPERATIONS AND COMPREHENSIVE LOSS
(in thousands, except share and per share data) (unaudited)
             
    Three Months Ended
September 30,
    Nine Months Ended
September 30,
 
    2026     2025     2026     2025  
Collaboration revenue   $ 4,220     $ 9,634     $ 17,758     $ 28,582  
Operating expenses:                        
Research and development(1)     82,254       62,151       204,396       168,711  
General and administrative(2)     13,473       10,295       40,595       30,987  
Total operating expenses     95,727       72,446       244,991       199,698  
Loss from operations     (91,507 )     (62,812 )     (227,233 )     (171,116 )
Other income (expense), net                        
Change in fair value of convertible preferred stock warrant liability     —       —       (363 )     —  
Interest expense     (192 )     (253 )     (529 )     (928 )
Interest income     4,149       3,105       11,691       11,175  
Foreign currency exchange loss     (58 )     (39 )     (62 )     (86 )
Total other income (expense), net     3,899       2,813       10,737       10,161  
Loss before provision for income taxes     (87,608 )     (59,999 )     (216,496 )     (160,955 )
Provision for income taxes     (49 )     (34 )     (130 )     (134 )
Net loss     (87,657 )     (60,033 )     (216,626 )     (161,089 )
Net loss attributable to non-controlling interests     —       (6,418 )     (268 )     (13,360 )
Net loss attributable to Generate Biomedicines, Inc. stockholders     (87,657 )     (53,615 )     (216,358 )     (147,729 )
Convertible preferred stock accrued dividends     —       (11,592 )     (7,749 )     (34,777 )
Net loss attributable to Generate Biomedicines, Inc. common stockholders   $ (87,657 )   $ (65,207 )   $ (224,107 )   $ (182,506 )
Net loss per share, basic and diluted   $ (0.68 )   $ (1.97 )   $ (2.09 )   $ (5.54 )
Weighted average common shares outstanding, basic and diluted     128,514,700       33,038,657       107,441,915       32,943,260  
Other comprehensive loss:                        
Net loss     (87,657 )     (60,033 )     (216,626 )     (161,089 )
Unrealized (loss) gain on marketable securities     (135 )     132       (370 )     4  
Comprehensive loss   $ (87,792 )   $ (59,901 )   $ (216,996 )   $ (161,085 )
Comprehensive loss attributable to non-controlling interest     —       (6,418 )     (268 )     (13,360 )
Comprehensive loss attributable to Generate Biomedicines, Inc. stockholders   $ (87,792 )   $ (53,483 )   $ (216,728 )   $ (147,725 )

(1) Includes related party amounts of $0.1 million for the nine months ended September 30, 2026, and $0.3 million for the nine months ended September 30, 2025. See Note 14 for details of related party amounts.
(2) Includes related party amounts of $0.1 million and $0.3 million for the three and nine months ended September 30, 2026, and $0.2 million and $0.5 million for the three and nine months ended September 30, 2025. See Note 14 for details of related party amounts.

Confirmation follows the Company’s elimination of $109 million of debt on October 27, 2026

SHOEMAKERSVILLE, Pa., Nov. 12, 2026 (GLOBE NEWSWIRE) — Hydrofarm Holdings Group, Inc. (“Hydrofarm” or the “Company”) (Nasdaq: HYFM) today announced that it has received confirmation from The Nasdaq Stock Market LLC (“Nasdaq”) by letter dated November 9, 2026, that the Company has regained compliance with Nasdaq Listing Rule 5550(b)(1), the $2.5 million minimum stockholders’ equity requirement for continued listing on The Nasdaq Capital Market (the “Equity Rule”).

“We received notice from Nasdaq that we are in compliance on our stockholders’ equity, another milestone in our financial restructuring,” said Bill Toler, Chairman and Chief Executive Officer. “With this confirmation, our organization is focused on profitable growth: our proprietary brands out of Eugene, the direct commercial sales channel that opened when the term loan was eliminated, and scaling logistics services under Project Agility. That’s where our 50th year starts.”

As previously disclosed, the Company was notified on April 1, 2026 that it did not satisfy the Equity Rule and subsequently requested a hearing before the Nasdaq Hearings Panel (the “Panel”). On October 27, 2026, the Company terminated its $109 million senior secured term loan and completed a registered direct offering and concurrent private placement, eliminating its outstanding debt(i) and restoring positive stockholders’ equity. Nasdaq’s confirmation follows its review of those transactions. 

The Company intends to monitor its stockholders’ equity and its compliance with the other Nasdaq continued listing requirements, including the minimum bid price requirement set forth in Nasdaq Listing Rule 5550(a)(2), and to take such actions as may be necessary to regain or maintain compliance.

The Company filed a Current Report on Form 8-K with the Securities and Exchange Commission (the “SEC”) regarding Nasdaq’s confirmation. Additional information regarding the October 27, 2026 transactions is set forth in the Company’s Current Reports on Form 8-K filed with the SEC on October 27, 2026 and in the Company’s press releases dated October 27, October 28, and November 3, 2026.

(i) Hydrofarm maintains an immaterial amount of ‘Other debt’ comprised of a foreign subsidiary’s revolving line of credit and mortgage.

About Hydrofarm Holdings Group, Inc.

Hydrofarm is a leading independent manufacturer and distributor of supplies and equipment for controlled environment agriculture, including plant nutrition, growing media, horticultural lighting and climate control solutions, spanning a portfolio of proprietary and select partner brands. The Company manufactures its proprietary plant nutrition and growing media brands in Eugene, Oregon, and, through its logistics services platform, provides third-party warehousing, fulfillment and distribution services across a wide range of industries. For nearly 50 years, Hydrofarm has helped growers make growing easier and more productive. The Company’s mission is to empower growers, farmers and cultivators with products that enable greater quality, efficiency, consistency and speed.

www.Hydrofarm.com

Forward-Looking Statements

This press release contains “forward-looking statements” within the meaning of the safe harbor provisions of the Private Securities Litigation Reform Act of 1995. Forward-looking statements may be identified by words such as “believe,” “expect,” “intend,” “anticipate,” “plan,” “will,” “project,” “potential” and similar expressions. They include, among others, statements regarding: the Company’s ability to maintain compliance with the Equity Rule; the Company’s ability to regain and maintain compliance with the Bid Price Rule and Nasdaq’s other continued listing requirements; the continued listing of the Company’s common stock on Nasdaq; the options the Company may pursue to regain compliance with the Bid Price Rule; and the Company’s growth plans for its proprietary brands, its logistics services platform and direct sales to commercial cultivators.

These statements are based on management’s current expectations and assumptions. They are subject to risks and uncertainties that could cause actual results to differ materially, including: the Company’s ability to maintain stockholders’ equity above the level required by the Equity Rule during the Mandatory Panel Monitor period and thereafter; the consequences if the Company is found again out of compliance with the Equity Rule during that period, including that no compliance plan or cure period would be available and the Company’s securities could be delisted; the Company’s ability to satisfy the Bid Price Rule and other Nasdaq continued listing standards; the Company’s history of operating losses; the Company’s ability to maintain and preserve liquidity and to access additional sources of capital; demand conditions in the controlled environment agriculture and hydroponics markets; and the other factors described under “Risk Factors” in the Company’s Annual Report on Form 10-K and subsequent periodic reports filed with the SEC. Forward-looking statements speak only as of the date of this release, and the Company undertakes no obligation to update them except as required by law.

CONTACT: Contact: ir@hydrofarm.com

Two rigs operating at Cerro Blanco with initial assays pending; drilling at San Juan targeted for December

CALGARY, Alberta, Nov. 12, 2026 (GLOBE NEWSWIRE) — San Lorenzo Gold Corp. (“San Lorenzo” or the “Company“) (TSXV: SLG) is pleased to provide an update on ongoing exploration activities at its flagship Salvadora Project in Chile’s Atacama Region, following the recent closing of its C$80 million financing on November 10, 2026.

The Company is advancing its diamond drilling campaign at Cerro Blanco, where two drill rigs are now operating, and preparing for the next phase of exploration at San Juan. In parallel, San Lorenzo is strengthening its technical and operational capabilities and developing a comprehensive exploration strategy to systematically evaluate multiple targets across the ~12,000-hectare Salvadora property in support of a continuous multi-rig program.

Exploration Highlights

  • Cerro Blanco drilling advancing: Two diamond drill rigs operating, with 1,818 metres drilled as of November 4, 2026, including four completed holes.
  • Expanded geological coverage: Drilling has progressed from an initial platform approximately 350 metres east of historical hole SAL-04-25 to a second platform approximately 250 metres farther north.
  • Drilling extended beyond planned depths: Three of the four completed holes exceeded their originally planned depths, including CB-04-26, which reached 513 metres compared with an initial planned depth of 350 metres.
  • Initial assays pending: Samples representing roughly 1,000 metres of drilling from the first three holes were delivered to the Andes Analytical Assay laboratory in Santiago on October 24, with an additional batch received on November 6. Initial results are expected in the coming weeks.
  • San Juan exploration advancing: The Company has internally approved its next phase of drilling, designed to systematically evaluate a potential northwest extension of the San Juan discovery area toward induced polarization (IP) line D11, with drilling targeted to commence in December 2026, subject to regulatory and operational readiness.

Management Commentary

Brandon Gaspar, Chief Executive Officer of San Lorenzo Gold, commented:

“With our financing complete, two rigs operating at Cerro Blanco and preparations advancing for drilling at San Juan, San Lorenzo is entering a new phase of exploration at Salvadora. Our strengthened balance sheet gives us the flexibility to scale our activities in a disciplined manner while continuing to expand our technical team and operational capabilities to support sustained drilling across multiple targets. Our objective is not simply to drill more metres, but to follow the geological evidence, systematically evaluate Salvadora’s potential and allocate capital where we believe it can create the greatest long-term shareholder value.”

Terence Walker, Vice President of Exploration, commented:

“Our initial drilling at Cerro Blanco identified thick intervals of gold mineralization that remain open in all directions. What we’re doing now is stepping out to understand the system around those intervals, and the early logging is encouraging from a geological standpoint. Two hundred and fifty metres north, CB-03-26 cut a broad zone of intrusive rocks and an interval of interpreted hydrothermal breccia, features we hadn’t seen this clearly at Cerro Blanco before. We’re careful not to get ahead of the assays, but these are exactly the kinds of observations that help us understand where the fluids moved. We’re looking forward to combining the logs with the first assay results. I’m also particularly excited about returning to San Juan, where the scale and strength of the IP anomaly northwest of our discovery holes presents a compelling target for systematic step-out drilling.”

Cerro Blanco – Drilling Progress and Geological Observations

Cerro Blanco is characterized by a lithocap with a surface footprint measuring approximately 2 kilometres across, representing an extensive zone of hydrothermal alteration. Previous drilling has identified substantial intervals of gold mineralization in the area, including 153.5 metres grading 1.04 g/t gold in hole SAL-01-24, 85.7 metres grading 1.02 g/t gold in hole SAL-02-24 and 132.2 metres grading 1.09 g/t gold in hole SAL-04-25, with the holes located hundreds of metres apart (see Company news releases dated March 3, 2025, March 17, 2025 and January 26, 2026, respectively). The current drilling program aims to build on these results, systematically testing areas surrounding known mineralization, evaluating potential extensions and advancing the Company’s geological model to guide further exploration.

Diamond drilling commenced at Cerro Blanco in September 2026, and a second rig began operating on October 31. As of November 4, the Company had completed 1,818 metres of drilling, including four completed holes, and both rigs continue to advance the campaign.

Expanded Drilling Coverage

The first two holes of the 2026 drill program, CB-01-26 and CB-02-26, were drilled from a common platform approximately 350 metres east of historical hole SAL-04-25. The two holes were drilled in opposing directions, providing additional geological information in the area east of the historical drill hole. Drilling subsequently progressed approximately 250 metres north to a second platform, where CB-03-26 and CB-04-26 were completed. Additional drilling is underway from the northern platform and the historical SAL-04-25 platform. Together, these step-outs are extending geological coverage across a broader portion of the Cerro Blanco target area.

Figure 1 Cerro Blanco drill plan showing historical drilling, completed and active holes.

Figure 1: Cerro Blanco drill plan showing historical drilling, completed and active holes.

Preliminary Geological Observations at Cerro Blanco

Geological logging of the initial drill holes has identified a varied assemblage of volcanic and intrusive rocks, including andesitic flows, porphyritic andesites, intermediate to felsic volcanic rocks, and volcaniclastic units comprising ash tuffs, lapilli tuffs and volcanic breccias.

The volcanic succession is locally associated with intrusive lithologies, including diorite porphyry, diorite and monzodiorite, together with intervals of alteration and brecciation.

At the initial eastern drilling locations, logging of CB-01-26 and CB-02-26 documented variations in volcanic lithology, alteration and oxidation characteristics, providing additional geological information for comparison with historical drilling.

Approximately 250 metres farther north, logging of CB-03-26 identified volcanic and intrusive lithologies, together with intervals of volcanic and interpreted hydrothermal brecciation. Geological observations from CB-04-26 are being incorporated into the Company’s ongoing interpretation.

Together, these observations are adding to the Company’s understanding of the distribution and relationships of volcanic, intrusive and altered rock units across Cerro Blanco. Detailed geological correlation between drill holes is ongoing, including the evaluation of lithological contacts, breccia characteristics, alteration and structural features.

Sampling and Assays

Core logging, sampling and laboratory submissions are ongoing. Samples representing approximately 1,000 metres of drilling from the first three holes were delivered to the laboratory on October 24, 2026, with an additional shipment received by the laboratory on November 6. Assay results from the current drilling remain pending. The Company expects to receive initial results in the coming weeks and will report them once they have been compiled, reviewed and interpreted in the context of the geological logging.

San Juan – Advancing the Next Phase of Exploration

In parallel with ongoing drilling at Cerro Blanco, San Lorenzo is advancing preparations for the next phase of exploration at San Juan, where previous drilling identified significant gold mineralization associated with the D8 IP anomaly. The Company has internally approved a follow-up drilling program designed to systematically evaluate the potential northwest extension of the San Juan mineralized system, progressing from the existing discovery area near IP line D8 toward line D11.

The planned drilling will target a geophysical trend extending approximately 1.5 kilometres northwest of the discovery holes SAL-10-25 (102.3 metres grading 1.33 g/t gold and 52.6 metres grading 1.67 g/t gold) and SAL-09-25 (58.5 metres grading 1.07 g/t gold and 60.3 metres grading 1.01 g/t gold) (see Company news releases dated March 2, 2026, May 8, 2026 and June 4, 2026), allowing the Company to evaluate the geological characteristics and potential continuity of the system over a substantially larger area.

Figure 2 San Juan plan view showing 2025 drill holes, IP lines D8 to D11 at 500-metre spacing, and the conceptual target area extending

Figure 2: San Juan plan view showing 2025 drill holes, IP lines D8 to D11 at 500-metre spacing, and the conceptual target area extending northwest from discovery holes SAL-09-25 and SAL-10-25.

Drilling will advance through systematic step-outs, with hole depths and subsequent drill locations refined based on geological observations and results as exploration progresses.

The Company is preparing the required exploration drilling notification for submission to Chile’s National Geology and Mining Service (SERNAGEOMIN) and advancing operational preparations for the program. San Lorenzo is targeting commencement of drilling in December 2026, subject to completion of the applicable regulatory process, drill pad construction and operational readiness.

Figure 3 Photographs of the two diamond drill rigs operating at Cerro Blanco

Figure 3: Photographs of the two diamond drill rigs operating at Cerro Blanco

Expanding Exploration Capacity and Longer-Term Planning

With its financing complete, San Lorenzo is refining a comprehensive exploration strategy for the next 18 to 24 months, encompassing ongoing drilling at Cerro Blanco, planned follow-up exploration at San Juan, and the systematic evaluation of additional targets across Salvadora. The addition of a second diamond drill rig at Cerro Blanco represents an initial step in expanding the company’s drill capacity.

Alongside drilling, San Lorenzo is strengthening its technical and operational capabilities, including geological personnel, core logging and processing capacity, sampling infrastructure, and supporting field operations, to support sustained exploration across multiple targets and the addition of further drill rigs.

Beyond Cerro Blanco and San Juan, the property hosts several additional exploration targets, including Caballo Muerto, Arco de Oro Epithermal Vein trend, Tres Amigos, 24K, Caballo Muerto South, Quebrada Salada and Rubi Lithocap prospective areas identified through geological mapping, surface sampling, geophysical surveys and limited reconnaissance drilling.

San Lorenzo is refining exploration priorities, drilling schedules, infrastructure requirements and associated budgets across these targets, and intends to provide further guidance on its exploration plans as this work progresses.

Figure 4 Aerial photograph of the Company's core logging and processing facilities.

Figure 4: Aerial photograph of the Company’s core logging and processing facilities.

Qualified Person
The scientific and technical information contained in this news release has been reviewed and approved by Eric L. Hanson, P.Geo., Senior Geologist at the Company’s Salvadora Project and a registered member of the Association of Professional Engineers and Geoscientists of the Province of Manitoba (APEGM). Mr. Hanson is a Qualified Person as defined under National Instrument 43-101 (“NI 43-101”) and is not independent of the Company.

Historical Qualified Person Disclosure
The Company has determined that Terence Walker, Vice President of Exploration, who was identified as the Qualified Person in certain historical news releases issued since October 1, 2022, did not maintain the professional registration required to qualify as a Qualified Person under NI 43-101 during the relevant period.

The Company has appointed Eric L. Hanson, P.Geo., as its Qualified Person for scientific and technical disclosure. Mr. Hanson has reviewed and approved the scientific and technical information contained in the Company’s historical disclosure during the relevant period and confirmed that no material corrections to that information are required.

About San Lorenzo

San Lorenzo Gold Corp. is a Canadian mineral exploration company advancing its 100%-owned Salvadora Project in Chile’s Atacama Region, approximately 15 kilometres from Codelco’s El Salvador copper-gold mine. The Company is conducting a systematic exploration program across the Salvadora property, including drilling, geophysics, surface exploration, and is testing a pipeline of exploration targets.

For further information, please contact:

San Lorenzo Gold Corp.
Brandon Gaspar, Chief Executive Officer
Email: info@slgold.com
Investor Relations: Acuity Advisory Corp.
Telephone: +1-604-837-5440

Cautionary Note Regarding Forward-Looking Information

This news release may contain forward-looking information that involves substantial known and unknown risks and uncertainties, most of which are beyond the control of San Lorenzo. All statements included herein other than statements of historical fact are forward-looking information. Forward-looking statements in this news release include, but are not limited to, the Company’s planned exploration and drilling programs at the Salvadora Project, including the nature, scope and timing of drilling and other exploration activities; the interpretation of exploration results and the potential extension and continuity of mineralization; the anticipated timing of receipt and reporting of assay results; the expansion of the Company’s technical and operational capabilities and drilling capacity; the Company’s exploration strategy and the timing of further guidance; and the Company’s future plans, objectives and growth strategy. Forward-looking information is based on assumptions management believes are reasonable, including the availability of drilling and laboratory capacity and the timely completion of regulatory processes, and is subject to risks including the uncertainties inherent in mineral exploration, delays in assay results, metal prices and conditions in Chile. There can be no assurance that such information will prove to be accurate, and actual results and future events could differ materially from those anticipated in such information. Any forward-looking statements are made as of the date of this release and, other than as required by applicable securities laws, San Lorenzo does not assume any obligation to update or revise them to reflect new events or circumstances.

Neither the TSX Venture Exchange nor its Regulation Services Provider (as that term is defined in the policies of the TSX Venture Exchange) accepts responsibility for the adequacy or accuracy of this news release.

Photos accompanying this announcement are available at
https://www.globenewswire.com/NewsRoom/AttachmentNg/e01aedee-ef62-4196-bfcd-7f8875f58613
https://www.globenewswire.com/NewsRoom/AttachmentNg/0f29f5f8-b426-4841-a82d-16085e4efc56
https://www.globenewswire.com/NewsRoom/AttachmentNg/d74bbc43-6554-47cf-bdef-fd9c2a9ca9fe
https://www.globenewswire.com/NewsRoom/AttachmentNg/9e746660-de93-4547-9905-18990746cd56

Significant reductions across non-invasive measures of liver fat, inflammation and fibrosis observed at 48 weeks of pemvidutide treatment, with generally favorable tolerability profile

Publication of results provides further validation for the balanced 1:1 glucagon/GLP-1 dual receptor agonist profile of pemvidutide

MORRISTOWN, N.J., Nov. 12, 2026 (GLOBE NEWSWIRE) — Altimmune, Inc. (Nasdaq: ALT), a biopharmaceutical company advancing pemvidutide, an investigational balanced 1:1 glucagon/GLP-1 dual receptor agonist, in serious liver diseases, today announced the publication of 48-week results from the IMPACT Phase 2b trial of pemvidutide in patients with metabolic dysfunction-associated steatohepatitis (MASH) in The Lancet Gastroenterology & Hepatology. The paper, titled “Safety and efficacy of weekly pemvidutide versus placebo for metabolic dysfunction-associated steatohepatitis (IMPACT): 48-week results from a multicentre, randomised, double-blind, phase 2b study,” reports secondary endpoints of MASH resolution and fibrosis improvement following 48 weeks of treatment.

The publication in The Lancet Gastroenterology & Hepatology builds upon the previously published 24-week results from IMPACT, in which pemvidutide met the primary endpoint of MASH resolution without worsening of fibrosis. (Safety and efficacy of weekly pemvidutide versus placebo for metabolic dysfunction-associated steatohepatitis (IMPACT): 24-week results from a multicentre, randomised, double-blind, phase 2b study) At Week 48, pemvidutide treatment resulted in significant reductions versus placebo across multiple non-invasive measures of liver fat, hepatic inflammation and fibrosis, together with significant weight loss. The results suggest continued improvement in liver health.

“Building on the findings presented at The Liver Meeting®, the published IMPACT results show that improvements seen earlier in treatment increased across multiple measures of liver health, including inflammation and, importantly, fibrosis,” said Mazen Noureddin, M.D., IMPACT trial principal investigator, Professor of Medicine at Houston Methodist Hospital and Co-Chair of the Board of Summit Clinical Research Solutions. “These findings are particularly encouraging given the role of fibrosis in long-term outcomes in MASH. Liver benefits were accompanied by weight loss and maintenance of glycemic control, with generally favorable gastrointestinal tolerability and no significant change in heart rate. Taken together, these results provide a strong foundation for the ongoing PERFORMA Phase 3 trial and give us real confidence in pemvidutide’s potential to become one of the next approved treatments for MASH.”

Weight loss with the 1.8 mg dose appeared to continue through the end of the 48-week treatment period, and no significant changes in heart rate were observed with treatment while glycemic control was maintained. Pemvidutide demonstrated a generally favorable tolerability profile over 48 weeks despite being administered without dose titration. Approximately 1% of total patients receiving pemvidutide discontinued treatment due to adverse events (AEs). The majority of AEs were mild to moderate, and no imbalances in cardiac AEs were observed with pemvidutide versus placebo. Most gastrointestinal AEs were mild to moderate in severity and predominantly occurred within the first 8 weeks.
 
“What is especially compelling about these 48-week results is the breadth of benefit we continue to see across the key drivers of MASH, from significant reductions in liver fat to continued improvements in measures of inflammation and fibrosis,” said Christophe Arbet-Engels, M.D., Ph.D., Chief Medical Officer of Altimmune. “Combined with meaningful weight loss and generally favorable tolerability, these data reinforce our belief that pemvidutide has the potential to offer a differentiated approach to treating MASH, and further derisk our Phase 3 PERFORMA trial. We look forward to continuing its execution to potentially deliver valuable treatment options to patients as rapidly as possible.”

About the IMPACT Phase 2b Study

The randomized, placebo-controlled, double-blind IMPACT Phase 2b trial (NCT05989711) enrolled 212 participants with biopsy-confirmed metabolic dysfunction-associated steatohepatitis (MASH) and fibrosis stages F2 or F3, with and without diabetes. Study participants were randomized 1:2:2 to receive weekly subcutaneous pemvidutide doses at either 1.2 mg, 1.8 mg or placebo for 48 weeks. The primary efficacy endpoints, measured at 24 weeks, were MASH resolution without worsening of fibrosis, or fibrosis improvement without worsening of MASH. Secondary endpoints included non-invasive tests of fibrosis and weight loss measured at 24 and 48 weeks.

About Pemvidutide

Pemvidutide is a novel investigational peptide with balanced 1:1 glucagon/GLP-1 dual receptor agonist activity that has an effect on reducing liver fat, inflammation, and fibrosis, in development for the treatment of metabolic dysfunction-associated steatohepatitis (MASH), alcohol use disorder (AUD) and alcohol-associated liver disease (ALD). The activation of glucagon receptors results in direct effects on the liver, while GLP-1 receptors mediate metabolic effects such as appetite suppression and weight loss and are involved in pathways related to craving and reward.

The FDA has granted Fast Track designations to pemvidutide for the treatment of MASH and AUD, as well as Breakthrough Therapy Designation for MASH. In December 2025, the Company announced topline 48-week data from the IMPACT Phase 2b trial in MASH. In July 2026, the PERFORMA Phase 3 trial, a global, randomized, double-blind, placebo-controlled, parallel-group study of pemvidutide in patients with MASH was initiated. In July 2026, the Company announced positive topline results from the RECLAIM Phase 2 trial in AUD. In August 2026, the Company announced completion of enrollment of the RESTORE Phase 2 trial in ALD.

About Altimmune

Altimmune is a biopharmaceutical company developing pemvidutide for patients with serious liver diseases. Pemvidutide, a unique dual-action investigational therapy targeting both glucagon and GLP-1 receptors in a balanced 1:1 ratio, is in late-stage clinical development for the treatment of metabolic dysfunction-associated steatohepatitis (MASH), recently showed robust results in the RECLAIM Phase 2 trial in alcohol use disorder (AUD) and is being studied in alcohol-associated liver disease (ALD). For more information, please visit www.altimmune.com.

Forward-Looking Statements
Any statements made in this press release related to the Company’s planning, development or commercialization of pemvidutide, an investigational product candidate, and other business, regulatory and financial matters including without limitation, clinical trial study design, status, correspondence, results and data, including the ongoing PERFORMA and RESTORE trials, and completed RECLAIM trial, the timing of key milestones for the Company’s clinical programs, future plans or expectations for pemvidutide for the treatment of MASH, AUD and ALD, the potential benefits of Fast Track and Breakthrough Therapy Designations, including potential regulatory timeline and approval benefits, the Company’s financial position, and the prospects for receiving regulatory approval or commercializing or selling any product or drug candidates are forward-looking statements within the meaning of the Private Securities Litigation Reform Act of 1995. In addition, when or if used in this press release, the words “may,” “could,” “should,” “anticipate,” “believe,” “estimate,” “expect,” “intend,” “plan,” “predict” and similar expressions and their variants, as they relate to Altimmune, Inc. may identify forward-looking statements. The Company cautions that these forward-looking statements are subject to numerous assumptions, risks, and uncertainties, which change over time. Important factors that may cause actual results to differ materially from the results discussed in the forward-looking statements or historical experience include risks and uncertainties, including risks relating to: delays in regulatory review, manufacturing and supply chain interruptions, access to clinical sites, enrollment, adverse effects on healthcare systems and disruption of the global economy; the reliability of the results of studies relating to human safety and possible adverse effects resulting from the administration of the Company’s product candidates; the Company’s ability to manufacture clinical trial materials on the timelines anticipated; and the success of future product advancements, including the success of future clinical trials. Further information on the factors and risks that could affect the Company’s business, financial conditions and results of operations are contained in the Company’s filings with the U.S. Securities and Exchange Commission, including under the heading “Risk Factors” in the Company’s most recent annual report on Form 10-K, quarterly report on Form 10-Q and the Company’s other filings with the SEC, which are available at www.sec.gov.

Investor Contact:
Luis Sanay, CFA
ir@altimmune.com

Media Contact:
Marisa Sharkey
media@altimmune.com

  • Breakthrough Therapy designation granted based on FDA’s review of safety and efficacy data from the chronic cohort of the Phase 1b/2a CONNECT SCI study
  • Phase 3 RESTORE registrational study enrolling participants, with site activation continuing in the United States and Canada

MIAMI, Nov. 12, 2026 (GLOBE NEWSWIRE) — NervGen (NASDAQ: NGEN), a late-stage clinical biopharmaceutical company developing first-in-class neuroreparative therapeutics for spinal cord injury (SCI) and other neurotraumatic and neurologic conditions, today announced that the U.S. Food and Drug Administration (FDA) has granted NVG-291 Breakthrough Therapy designation for the treatment of chronic traumatic cervical motor-incomplete SCI. NVG-291 is being developed as potentially the first therapy to promote nerve regeneration in individuals living with chronic SCI.

Preliminary clinical evidence from the Phase 1b/2a CONNECT SCI study demonstrated substantial improvements on a clinically significant endpoint assessing functional hand use in individuals with chronic traumatic cervical motor-incomplete SCI. These findings were supported by Patient Global Impression of Change (PGIC) and blinded qualitative interviews documenting participant-reported gains in everyday function and independence compared to placebo. NVG-291 was generally well tolerated, with no serious adverse events or treatment discontinuations.

“Receiving Breakthrough Therapy designation for NVG-291 underscores the FDA’s recognition of the promising clinical data that NVG-291 has the potential to demonstrate substantial improvement over current treatments for individuals living with chronic SCI,” said Shamim Ruff, Chief Regulatory Affairs Officer of NervGen. “NVG-291 is designed to facilitate the body’s natural ability to regenerate and repair its nervous system, with the goal of achieving functional recovery even years after injury. We appreciate the FDA’s continued engagement and look forward to building on this collaboration as we advance our ongoing Phase 3 RESTORE study.”

“This designation brings renewed hope to the more than 300,000 individuals living with traumatic SCI in the United States and many more around the world,” said Andrew Wagner, CEO of Wings for Life USA. “For someone living with a long-standing injury, even small gains in function can make a profound difference to quality of life and everyday independence. Wings for Life is committed to funding clinical research that advances the possibility for recovery. As a supporter of the CONNECT SCI study, we are encouraged by the progress of NVG-291 and share the SCI community’s urgency to translate promising clinical findings into treatments that improve people’s lives.”

Breakthrough Therapy designation is a process designed to expedite the development and review of drugs that are intended to treat a serious condition for which preliminary clinical evidence indicates that the drug may demonstrate substantial improvement over available therapy on one or more clinically significant endpoints. The benefits of Breakthrough Therapy designation include eligibility for Priority Review, rolling submission of sections of the New Drug Application and FDA’s organizational commitment to help determine an efficient route to approval.

About the Phase 3 RESTORE Study
RESTORE is a multicenter, randomized, double-blind, placebo-controlled Phase 3 registrational study evaluating the efficacy and safety of NVG-291 in adults living with chronic traumatic cervical motor-incomplete SCI. The study is expected to enroll approximately 150 participants across the United States and Canada. The study’s primary endpoint assesses improvement in hand function, a leading recovery priority for individuals with cervical SCI, as measured by GRASSP Quantitative Prehension. Secondary endpoints and blinded participant interviews will provide additional insight into functional independence and quality of life. Eligible participants are one to ten years following a traumatic SCI, have a motor level at C7 or higher on both sides and have an American Spinal Injury Association (ASIA) Impairment Scale classification of C or D. Participants will be randomized 1:1 to receive NVG-291 or placebo by once-daily subcutaneous injection for 12 weeks, followed by a four-week observation period. An optional 12-week open-label extension is planned following study completion. For additional information, including eligibility criteria and study locations, visit ClinicalTrials.gov (identifier: NCT07799532).

About Spinal Cord Injury

Spinal cord injury (SCI) disrupts communication between the brain and body and can result in lasting impairments in voluntary movement, sensation and autonomic function. Approximately 312,000 people in the United States are living with traumatic SCI, and about 18,500 new injuries occur each year. For individuals with cervical SCI, regaining arm and hand function is a leading recovery priority because of its importance to everyday independence and quality of life.

Following SCI, increased levels of chondroitin sulfate proteoglycans (CSPGs), molecules found in the extracellular matrix, contribute to an environment that inhibits nervous system repair. CSPGs act through receptors, including protein tyrosine phosphatase sigma (PTPσ), to inhibit nerve fiber regrowth and sprouting, limiting the potential for recovery. There are currently no FDA-approved pharmacologic therapies to restore lost neurologic function in individuals living with chronic SCI.

About NervGen
NervGen (NASDAQ: NGEN) is a late-stage clinical biopharmaceutical company developing first-in-class neuroreparative therapeutics for spinal cord injury (SCI) and other neurotraumatic and neurologic conditions. The Company’s mission is to transform the lives of individuals living with SCI by enabling the nervous system to repair itself. NervGen’s lead therapeutic candidate, NVG-291, is a subcutaneously administered neuroreparative peptide designed to target the inhibitory CSPG-PTPσ pathway. NVG-291 is the first pharmacologic candidate to improve function, independence, and quality of life in chronic SCI, as observed in the Phase 1b/2a CONNECT SCI study. NVG-291 has received Breakthrough Therapy designation from the FDA for the treatment of chronic traumatic cervical motor-incomplete SCI. It has also received Fast Track designation from the FDA and Orphan Drug designation from the European Medicines Agency for the treatment of SCI. Through NVG-291 and its next-generation candidate, NVG-300, NervGen is pursuing a pharmacologic approach to transform the treatment paradigm for neurotraumatic and neurologic conditions with significant unmet medical need. For more information, visit www.nervgen.com and follow NervGen on X and LinkedIn.

Cautionary Note Regarding Forward-Looking Statements
This news release contains “forward-looking information” and “forward-looking statements” within the meaning of applicable securities laws (collectively, “forward-looking statements”). Statements regarding the Company’s current and future plans, expectations and intentions, results, levels of activity, performance, goals or achievements, and other future events or developments constitute forward-looking statements. The words “may”, “will”, “would”, “should”, “could”, “expect”, “plan”, “intend”, “anticipate”, “believe”, “estimate”, “predict”, “likely” or “potential”, or the negative or other variations of these words or other comparable words or phrases, are intended to identify forward-looking statements. Forward-looking statements include, without limitation, statements relating to: the potential benefits of Breakthrough Therapy designation, including its potential to expedite the development and regulatory review of NVG-291, and the Company’s planned interactions with the FDA; the design, conduct, expected enrollment and anticipated timelines of the RESTORE study, including the planned open-label extension; the development and potential therapeutic benefits of the Company’s product candidates; and other factors described in the “Risk Factors” section of the Company’s most recently filed Annual Information Form and Annual Report on Form 40-F/A, its amended and restated management’s discussion and analysis for the year ended December 31, 2025, and subsequent filings with Canadian securities regulators and the U.S. Securities and Exchange Commission. These documents are available under the Company’s profile on SEDAR+ at www.sedarplus.ca and on the SEC’s website at www.sec.gov. Breakthrough Therapy designation does not guarantee regulatory approval of NVG-291, and results from earlier clinical studies may not be predictive of results from subsequent studies. Readers should not place undue reliance on forward-looking statements made in this news release. Unless otherwise stated, the forward-looking statements contained in this news release are made as of the date of this news release, and the Company has no intention and undertakes no obligation to update or revise any forward-looking statements, whether as a result of new information, future events or otherwise, except as required by applicable law. The forward-looking statements contained in this news release are expressly qualified by this cautionary statement.

Contacts
On365 Partners, Investor Relations
ir@nervgen.com
203.293.8091

PENNSAUKEN, N.J., Nov. 12, 2026 (GLOBE NEWSWIRE) — RCM Technologies, Inc. (NasdaqGM: RCMT), a premier provider of solutions designed to enhance the operational performance of its customers through the deployment of advanced engineering, specialty healthcare, and information technology services, today announced financial results for the thirteen and thirty-nine weeks ended October 3, 2026.

RCMT reported revenue of $73.4 million for the thirteen weeks ended October 3, 2026 (the current quarter), an increase of 4.4% compared to $70.3 million for the thirteen weeks ended September 27, 2025 (the comparable prior quarter). Gross profit was $19.9 million for the current quarter, a 2.7% increase from $19.4 million for the comparable prior quarter. The Company experienced GAAP net income of $2.7 million, or $0.37 per diluted share, for the current quarter compared to $2.3 million, or $0.30 per diluted share, for the comparable prior quarter. The Company experienced adjusted EBITDA (non-GAAP) of $6.3 million for the current quarter, as compared to $5.5 million for the comparable prior quarter, an increase of 14.2%. The Company experienced $0.53 of adjusted net income per diluted share (non-GAAP) for the current quarter as compared to $0.42 for the comparable prior quarter, an increase of 26.2%.

RCMT reported revenue of $250.3 million for the thirty-nine weeks ended October 3, 2026 (the current period), an increase of 7.4% compared to $232.9 million for the thirty-nine weeks ended September 27, 2025 (the comparable prior-year period). Gross profit was $66.0 million for the current period, a 3.7% increase from $63.7 million for the comparable prior-year period. The Company experienced GAAP net income of $11.5 million, or $1.56 per diluted share, for the current period compared to $10.2 million, or $1.34 per diluted share, for the comparable prior-year period. The Company experienced adjusted EBITDA (non-GAAP) of $23.8 million for the current period, as compared to $21.4 million for the comparable prior-year period, an increase of 11.0%. The Company experienced $2.01 of adjusted net income per diluted share (non-GAAP) for the current period as compared to $1.73 for the comparable prior-year period, an increase of 16.2%.

About RCM
RCM Technologies, Inc. (NasdaqGM: RCMT) is a business and technology solutions provider with world-class talent in key market segments. We help design, build, and enable the Industries of Tomorrow, Today. Operating at the intersection of resources, critical infrastructure and modernization of industries, RCM is a provider of services in Healthcare, Engineering, Aerospace & Defense, Process & Industrial, Life Sciences and Data & Solutions. www.rcmt.com.

The statements contained in this release that are not purely historical are forward-looking statements within the Private Securities Litigation Reform Act of 1995. They are subject to various risks, uncertainties, and other factors that could cause the Company’s actual results, performance, or achievements to differ materially from those expressed or implied by such forward-looking statements. These statements often include words such as “may,” “will,” “expect,” “anticipate,” “continue,” “estimate,” “project,” “intend,” “believe,” “plan,” “seek,” “could,” “can,” “should,” “are confident” or similar expressions. In addition, statements that are not historical should also be considered forward-looking statements. These statements are based on assumptions that we have made in light of our experience in the industry, and our perceptions of historical trends, current conditions, expected future developments, and other factors we believe are appropriate in these circumstances. Forward-looking statements include, but are not limited to, those relating to demand for the Company’s services, expectations regarding our future revenues and other financial results, such as cash flows, our pipeline, and potential project wins, and our expectations for investment and growth in our business. Such statements are based on current expectations that involve several known and unknown risks, uncertainties, and other factors, which may cause actual events to be materially different from those expressed or implied by such forward-looking statements. Risk, uncertainties, and other factors may emerge from time to time that could cause the Company’s actual results to differ from those indicated by the forward-looking statements. Investors are directed to consider such risks, uncertainties, and other factors described in documents filed by the Company with the Securities and Exchange Commission, including our most recent Annual Report on Form 10-K and subsequent Quarterly Reports on Form 10-Q. The Company assumes no obligation (and expressly disclaims any such obligation) to update any forward-looking statements contained in this release as a result of new information or future events or developments, except as may be required by law.

Tables to Follow

RCM Technologies, Inc.
Condensed Consolidated Statements of Operations
(Unaudited)
(In Thousands, Except Share and Per Share Amounts)
 
  Thirteen Weeks Ended  
  October 3,
2026
  September 27,
2025
 
Revenue $73,401   $70,289  
Cost of services   53,475     50,879  
Gross profit   19,926     19,410  
Selling, general and administrative   14,823     14,933  
Depreciation and amortization of property and equipment   565     539  
Operating income   4,538     3,938  
Other expense, net   427     614  
Income before income taxes   4,111     3,324  
Income tax expense   1,395     1,065  
Net income $2,716   $2,259  
         
Diluted net earnings per share data $0.37   $0.30  
Diluted weighted average shares outstanding   7,303,227     7,614,695  
             

  Thirty-Nine Weeks Ended  
  October 3,
2026
  September 27,
2025
 
Revenue $250,255   $232,928  
Cost of services   184,225     169,263  
Gross profit   66,030     63,665  
Selling, general and administrative   45,920     45,179  
Depreciation and amortization of property and equipment   1,677     1,364  
Operating income   18,433     17,122  
Other expense, net   1,726     2,241  
Income before income taxes   16,707     14,881  
Income tax expense   5,246     4,651  
Net income $11,461   $10,230  
         
Diluted net earnings per share data $1.56   $1.34  
Diluted weighted average shares outstanding   7,358,846     7,656,929  
             

RCM Technologies, Inc.
Supplemental Operating Results on a Non-GAAP Basis
(Unaudited)
(In Thousands, Except Per Share Amounts)

The following non-GAAP measures, which adjust for the categories of expenses described below, are non-GAAP financial measures. Our management believes that these non-GAAP financial measures (“Adjusted operating income,” “EBITDA,” “Adjusted EBITDA,” “Adjusted net income” and “Adjusted diluted net earnings per share”) are useful information for investors, shareholders, and other stakeholders of our Company in gauging our results of operations on an ongoing basis and to enhance investors’ overall understanding of our current financial performance and period-to-period comparisons. Adjusted operating income, EBITDA, Adjusted EBITDA, Adjusted net income and Adjusted diluted net earnings per share should not be considered alternatives to operating income or net income, as the case may be, as an indicator of performance. In addition, Adjusted operating income, EBITDA, Adjusted EBITDA, Adjusted net income and Adjusted diluted net earnings per share do not take into account changes in certain assets and liabilities and interest and income taxes that can affect cash flows. We do not intend the presentation of these non-GAAP measures to be considered in isolation or as a substitute for results prepared in accordance with GAAP. These non-GAAP measures should be read-only in conjunction with our consolidated financial statements prepared in accordance with GAAP.

The following unaudited table presents the Company’s GAAP operating income and GAAP net income and the corresponding adjustments used to calculate Adjusted operating income, EBITDA, Adjusted EBITDA, Adjusted net income and Adjusted diluted net earnings per share for the thirteen and thirty-nine weeks ended October 3, 2026, and September 27, 2025.  

  Thirteen Weeks Ended   Thirty-Nine Weeks Ended  
  October 3,
2026
  September 27,
2025
  October 3,
2026
September 27,
2025
 
  (Unaudited)   (Unaudited)   (Unaudited)   (Unaudited)  
                 
GAAP operating income $4,538   $3,938   $18,433   $17,122  
Adjustments                
Excess professional fees   –     –     647     –  
Equity compensation   1,191     1,033     3,023     2,939  
Adjusted operating income (non-GAAP) $5,729   $4,971   $22,103   $20,061  
                 
GAAP net income $2,716   $2,259   $11,461   $10,230  
Income tax expense   1,395     1,065     5,246     4,651  
Interest expense, net   448     584     1,819     1,885  
Depreciation of property and equipment   565     539     1,677     1,364  
EBITDA (non-GAAP) $5,124   $4,447   $20,203   $18,130  
                 
Adjustments                
Excess professional fees   –     –     647     –  
(Gain) loss on foreign currency transactions   (21 )   30     (93 )   356  
Equity compensation   1,191     1,033     3,023     2,939  
Adjusted EBITDA (non-GAAP) $6,294   $5,510   $23,780   $21,425  
                 

RCM Technologies, Inc.
Supplemental Operating Results on a Non-GAAP Basis (Continued)
(Unaudited)
(In Thousands)
 
  Thirteen Weeks Ended   Thirty-Nine Weeks Ended  
  October 3,
2026

  September 27,
2025
October 3,
2026
  September 27,
2025
 
  (Unaudited)   (Unaudited)   (Unaudited)   (Unaudited)  
                 
GAAP net income $2,716   $2,259   $11,461   $10,230  
Adjustments                
Excess professional fees   –     –     647     –  
(Gain) loss on foreign currency transactions   (21 )   30     (93 )   356  
Equity compensation   1,191     1,033     3,023     2,939  
Tax impact from normalized rate   (31 )   (119 )   (231 )   (257 )
Adjusted net income (non-GAAP) $3,855   $3,203   $14,807   $13,268  
                 
GAAP diluted net earnings per share $0.37   $0.30   $1.56   $1.34  
Adjustments                
Excess professional fees   –     –   $0.08     –  
(Gain) loss on foreign currency transactions ($0.00 ) $0.01   ($0.01 ) $0.05  
Equity compensation $0.16   $0.13   $0.41   $0.38  
Tax impact from normalized rate(a) ($0.00 ) ($0.02 ) ($0.03 ) ($0.04 )
Adjusted diluted net earnings per share (non-GAAP) $0.53   $0.42   $2.01   $1.73  
                         

(a) Amount reflects an adjustment to income tax expense applied to non-GAAP adjusted consolidated taxable income. The Company used an estimated effective income tax rate of 27.0% for both periods presented, approximating the Company’s federal USA income tax rate plus the tax-affected rate for states and Puerto Rico.
   

RCM Technologies, Inc.
Summary of Selected Income Statement Data
(Unaudited)
(In Thousands)
 
  Thirteen Weeks Ended October 3, 2026  
  Specialty
Healthcare
  Engineering   Life Sciences,
Data and Solutions
  Consolidated  
                 
Revenue $33,709   $30,743   $8,949   $73,401  
Cost of services   25,113     22,783     5,579     53,475  
Gross profit $8,596   $7,960   $3,370   $19,926  
Gross profit margin   25.5 %   25.9 %   37.7 %   27.1 %
                         

  Thirteen Weeks Ended September 27, 2025  
  Specialty
Healthcare
  Engineering   Life Sciences,
Data and Solutions
  Consolidated  
                 
Revenue $30,000   $31,419   $8,870   $70,289  
Cost of services   21,010     24,507     5,362     50,879  
Gross profit   8,990     6,912     3,508     19,410  
Gross profit margin   30.0 %   22.0 %   39.5 %   27.6 %
                         

  Thirty-Nine Weeks Ended October 3, 2026  
  Specialty
Healthcare
  Engineering   Life Sciences,
Data and Solutions
   
Consolidated
 
                 
Revenue $126,541   $96,405   $27,309   $250,255  
Cost of services   91,341     76,103     16,781     184,225  
Gross profit $35,200   $20,302   $10,528   $66,030  
Gross profit margin   27.8 %   21.1 %   38.6 %   26.4 %
                         

  Thirty-Nine Weeks Ended September 27, 2025  
  Specialty
Healthcare
  Engineering   Life Sciences,
Data and Solutions
  Consolidated  
                 
Revenue $116,105   $90,082   $26,741   $232,928  
Cost of services   82,634     70,496     16,133     169,263  
Gross profit   33,471     19,586     10,608     63,665  
Gross profit margin   28.8 %   21.7 %   39.7 %   27.3 %
                         

RCM Technologies, Inc.
Consolidated Balance Sheets
(Unaudited)
(In thousands, except share amounts)
 
  October 3,   January 3,
  2026   2026
         
Current assets:        
  Cash $1,884   $2,922  
  Accounts receivable and contract assets, net of provision for credit losses of $871 at October 3, 2026 and January 3, 2026   85,016     81,243  
  Transit accounts receivable   6,272     8,017  
  Prepaid expenses and other current assets   6,282     7,704  
    Total current assets   99,454     99,886  
             
Property and equipment, net   6,369     7,265  
         
Other assets:        
  Deposits   261     261  
  Deferred tax assets, foreign   6     6  
  Goodwill   22,147     22,147  
  Operating right of use assets   4,945     4,832  
    Total other assets   27,359     27,246  
             
    Total assets $133,182   $134,397  

Current liabilities:        
  Accounts payable and accrued expenses $14,590   $9,649  
  Transit accounts payable   8,993     16,247  
  Accrued payroll and related costs   13,246     10,784  
  Finance lease payables   799     843  
  Income taxes payable   50     391  
  Operating lease liabilities   1,194     1,209  
  Deferred revenue   9,058     14,761  
    Total current liabilities   47,930     53,884  
         
Deferred income taxes, net, domestic   5,673     5,673  
Finance lease payables, net of current portion   –     380  
Operating lease liabilities, net of current portion   3,941     3,813  
Borrowings under revolving credit facility   22,682     24,673  
  Total liabilities   80,226     88,423  
         
Contingencies (note 16) and Commitments (note 15)        
         
Stockholders’ equity:        
    Preferred stock, $1.00 par value; 5,000,000 shares authorized; no shares issued or outstanding   –     –  
    Common stock, $0.05 par value; 40,000,000 shares authorized; 18,132,420 shares issued and 7,131,213 shares outstanding at October 3, 2026 and 18,004,241 shares issued and 7,351,400 shares outstanding at January 3, 2026   906     900  
  Additional paid-in capital   124,755     122,244  
  Accumulated other comprehensive loss   (3,164 )   (2,814 )
  Retained earnings   21,857     10,396  
  Treasury stock at cost, 11,001,207 shares at October 3, 2026 and 10,652,841 shares at January 3, 2026   (91,398 )   (84,752 )
    Stockholders’ equity   52,956     45,974  
             
    Total liabilities and stockholders’ equity $133,182   $134,397  
                 

RCM Technologies, Inc.
Condensed Consolidated Statements of Cash Flows
(Unaudited)
(In Thousands)
 
  Thirteen Weeks Ended  
  October 3
2026
  September 27,
2025
 
Net income $2,716   $2,259    
Adjustments to reconcile net income to cash used in operating activities   1,581     1,825    
Changes in operating assets and liabilities:        
  Accounts receivable and contract assets   (3,208 )   515    
  Prepaid expenses and other current assets   (599 )   (175 )  
  Net of transit accounts receivable and payable   (5,124 )   (7,659 )  
  Accounts payable and accrued expenses   203     3,312    
  Accrued payroll and related costs   372     2,431    
  Operating lease liabilities   (181 )   (274 )  
  Income taxes payable   (301 )   (538 )  
  Deferred revenue   819     (2,939 )  
  Deposits   –     (19 )  
Total adjustments   (6,438 )   (3,521 )  
Net cash used in operating activities   (3,722 )   (1,262 )  
         
Net cash used in investing activities   (276 )   (498 )  
Net cash used in financing activities   (603 )   (2,379 )  
Effect of exchange rate changes on cash   (100 )   (24 )  
Decrease in cash ($4,701 ) ($4,163 )  
               

  Thirty-Nine Weeks Ended  
  October 3
2026
  September 27,
2025
 
Net income $11,461   $10,230    
Adjustments to reconcile net income to cash used in operating activities   5,175     5,080    
Changes in operating assets and liabilities:        
  Accounts receivable and contract assets   (3,488 )   (5,249 )  
  Prepaid expenses and other current assets   1,420     2,865    
  Net of transit accounts receivable and payable   (5,509 )   (9,330 )  
  Accounts payable and accrued expenses   5,155     (69 )  
  Accrued payroll and related costs   2,480     2,860    
  Operating lease liabilities   (804 )   (809 )  
  Income taxes payable   (337 )   (108 )  
  Deferred revenue   (5,734 )   2,098    
  Deposits   (1 )   (48 )  
Total adjustments   (1,643 )   (2,710 )  
Net cash provided by operating activities   9,818     7,520    
         
Net cash used in investing activities   (477 )   (1,398 )  
Net cash used in financing activities   (9,875 )   (9,471 )  
Effect of exchange rate changes on cash   (504 )   (71 )  
Decrease in cash ($1,038 ) ($3,420 )  
               

RCM Technologies, Inc. Tel:  856.356.4500 Corporate Contacts:
2500 McClellan Avenue info@rcmt.com Bradley S. Vizi
Pennsauken, NJ 08109 www.rcmt.com Executive Chairman
    Kevin D. Miller
    Chief Financial Officer

BROOKFIELD, NEWS, Nov. 12, 2026 (GLOBE NEWSWIRE) — Brookfield Wealth Solutions (NYSE, TSX: BNT) today announced financial results for the quarter ended September 30, 2026.

Sachin Shah, CEO of Brookfield Wealth Solutions, stated, “Our business continues to deliver strong results as we execute on our growth strategy and leverage Brookfield’s global investment capabilities. We are making meaningful progress optimizing our U.K. operations, expanding our distribution capabilities and repositioning our investment portfolio to generate attractive risk-adjusted returns. With a strong capital base and a growing global platform, we remain well positioned to deliver durable earnings and long-term growth.”

Unaudited
As of and for the periods ended September 30
(US$ millions, except per share amounts)
Three Months Ended   Nine Months Ended
  2026     2025     2026     2025
Total assets $ 203,851   $ 152,821   $ 203,851   $ 152,821
Distributable operating earnings1   519     427     1,445     1,262
Net income   863     608     410     842
Net income per each class A share2 $ 0.07   $ 0.06   $ 0.21   $ 0.18
  1. See Non-GAAP and Performance Measures on page 7 and a reconciliation from net income on page 6.
  2. Per share amounts have been adjusted to reflect the three-for-two stock split completed on October 9, 2025.


Third Quarter Highlights

  • Originated $4 billion of annuity sales across our retail and pension risk transfer channels.
  • Deployed over $8 billion into Brookfield originated strategies across our investment portfolio at an average target yield of 8%.
  • Continued to optimize the Just Group platform, including deploying £1.3 billion into Brookfield investment strategies and advancing initiatives to improve long-term returns.

Operating Update

We recognized $519 million and $1.4 billion of distributable operating earnings (“DOE”) for the three and nine months ended September 30, 2026, compared to $427 million and $1.3 billion in the prior year periods, respectively. The current period DOE reflects a full quarter of contribution from Just Group, and higher net investment income as a result of organic growth and continued asset redeployment into our Brookfield strategies, as well as continued improvement in underwriting results within our Property and Casualty segment.

We recorded net income of $863 million and $410 million for the three and nine months ended September 30, 2026, compared to net income of $608 million and $842 million in the prior year periods, respectively. The net income includes the benefit of our strong DOE performance coupled with favorable movements related to unrealized mark-to-market on inflation derivatives and insurance reserves.

Today, we are in a strong liquidity position, with approximately $33 billion of cash and short-term liquid investments across our investment portfolios, and another approximately $42 billion of long-term liquid investments. These liquid assets position us well to meet policyholder obligations and support the ongoing rotation of our portfolio into higher yielding investment strategies.

Corporate Simplification Update

We expect to complete the previously announced corporate simplification transaction of our Company and Brookfield Corporation (the “Transaction”) on December 1, 2026, subject to all closing conditions being satisfied or waived. Class A shares of Brookfield Corporation Ltd. are expected to begin trading on the NYSE and TSX under the symbol “BN” on December 3, 2026.

Shareholders of our Company are not required to take any action.

Regular Distribution Declaration

Shareholders of record as of the close of business on December 16, 2026 (the “Record Date”) will receive a cash distribution of $0.07 per share on December 31, 2026.

Brookfield Corporation Operating Results

An investment in class A shares of our company is intended to be, as nearly as practicable, functionally and economically, equivalent to an investment in the Brookfield class A shares. A summary of Brookfield Corporation’s third quarter operating results is provided below:

Unaudited
For the periods ended September 30
(US$ millions, except per share amounts)
Three Months Ended   Last Twelve Months Ended
  2026     2025     2026     2025
Net income of consolidated business1 $ 1,914   $ 284   $ 5,340   $ 1,655
Net income attributable to Brookfield shareholders2   1,305     219     2,514     996
Distributable earnings before realizations3   1,496     1,333     5,815     5,385
– Per Brookfield class A share3,4   0.64     0.56     2.47     2.27
Distributable earnings3   1,718     1,487     6,403     6,027
– Per Brookfield class A share3,4   0.73     0.63     2.72     2.54
  1. Consolidated basis – includes amounts attributable to non-controlling interests.
  2. Excludes amounts attributable to non-controlling interests.
  3. See Reconciliation of Net Income to Distributable Earnings on page 6 and Non-IFRS and Performance Measures on page 9 of Brookfield Corporation’s press release dated November 12, 2026.
  4. Per share amounts have been adjusted to reflect Brookfield Corporation’s three-for-two stock split completed on October 9, 2025.

Brookfield Corporation net income above is presented under IFRS. Given the economic equivalence, we expect that the market price of the class A shares of our company will be impacted significantly by the market price of the Brookfield class A shares and the business performance of Brookfield as a whole. In addition to carefully considering the disclosure made in this news release in its entirety, shareholders are strongly encouraged to carefully review Brookfield Corporation’s letter to shareholders, supplemental information and its other continuous disclosure filings. Investors, analysts and other interested parties can access Brookfield Corporation’s disclosure on its website under the Reports & Filings section at bn.brookfield.com.

Consolidated Balance Sheets

           
Unaudited
(US$ millions)
  September 30     December 31
    2026       2025
Assets          
           
Cash, cash equivalents and short-term investments   $ 12,795     $ 13,489
Investments     156,352       109,569
Reinsurance funds withheld     1,549       1,435
Accrued investment income     1,615       892
Deferred policy acquisition costs     11,905       11,683
Reinsurance recoverables and deposit assets     11,038       12,151
Other assets     8,597       7,962
Total assets     203,851       157,181
           
Liabilities and equity          
           
Policyholders’ account balances     98,140       94,411
Future policy benefits     50,509       16,249
Policy and contract claims     6,693       7,277
Market risk benefits     4,242       4,536
Unearned premium reserve     1,354       1,272
Funds withheld for reinsurance liabilities     2,809       3,157
Corporate borrowings     2,672       628
Non-recourse borrowings     7,044       4,857
Other liabilities     13,052       6,877
           
Class A and class B 1,369     1,378  
Class C 15,626     16,208  
Non-controlling interest 341   17,336   331   17,917
Total liabilities and equity   $ 203,851     $ 157,181
               


Consolidated Statements of Operations

Unaudited
For the periods ended September 30
(US$ millions)
Three Months Ended   Nine Months Ended
  2026       2025       2026       2025  
Net premiums and other policy revenue $ 1,252     $ 1,002     $ 4,132     $ 3,532  
Net investment income, including funds withheld   2,201       1,493       5,828       4,408  
Net investment gains (losses), including funds withheld   196       431       (438 )     641  
Total revenues   3,649       2,926       9,522       8,581  
               
Benefits and claims paid on insurance contracts   (1,654 )     (744 )     (4,611 )     (2,930 )
Interest sensitive contract benefits   (655 )     (534 )     (1,988 )     (1,555 )
Amortization of deferred policy acquisition costs   (383 )     (380 )     (1,094 )     (1,082 )
Change in fair value of insurance-related derivatives and embedded derivatives   441       185       534       (146 )
Change in fair value of market risk benefits   436       (310 )     189       (625 )
Operating expenses   (488 )     (274 )     (1,416 )     (981 )
Interest expense   (161 )     (112 )     (409 )     (267 )
Total benefits and expenses   (2,464 )     (2,169 )     (8,795 )     (7,586 )
Net income before income taxes   1,185       757       727       995  
Income tax expense   (322 )     (149 )     (317 )     (153 )
Net income $ 863     $ 608     $ 410     $ 842  
               
Attributable to:              
Class A and class B shareholders1 $ 5     $ 4     $ 15     $ 12  
Class C shareholder   850       579       374       746  
Non-controlling interest   8       25       21       84  
  $ 863     $ 608     $ 410     $ 842  
  1. Class A shares receive distributions at the same amount per share as the cash dividends paid on each Brookfield class A share.


Summarized Financial Results

Reconciliation of Net Income to Distributable Operating Earnings

Unaudited
For the periods ended September 30
(US$ millions)
Three Months Ended   Nine Months Ended
  2026       2025       2026     2025  
Net income $ 863     $ 608     $ 410   $ 842  
Unrealized net investment losses (gains), including funds withheld   (196 )     (431 )     438     (641 )
Mark-to-market losses (gains) on insurance contracts and other net assets   (490 )     132       171     951  
    177       309       1,019     1,152  
Deferred income tax expense (recovery)   239       55       65     (124 )
Transaction costs   58       12       213     67  
Depreciation   45       51       148     167  
Distributable operating earnings1 $ 519     $ 427     $ 1,445   $ 1,262  
  1. Non-GAAP measure – see Non-GAAP and Performance Measures on page 7.


Additional Information

The statements contained herein are based primarily on information that has been extracted from our financial statements for the quarter ended September 30, 2026, which have been prepared using generally accepted accounting principles in the United States of America (“US GAAP” or “GAAP”).

Brookfield Wealth Solutions’ Board of Directors have reviewed and approved this document, including the summarized unaudited consolidated financial statements prior to its release.

Information on our distributions can be found on our website under Stock & Distributions/Distribution History.

Brookfield Wealth Solutions Ltd. (NYSE, TSX: BNT) is focused on securing the financial futures of individuals and institutions through a range of retirement services, wealth protection products and tailored capital solutions. Each class A exchangeable limited voting share of Brookfield Wealth Solutions is exchangeable on a one-for-one basis with a class A limited voting share of Brookfield Corporation (NYSE, TSX: BN). For more information, please visit our website at bnt.brookfield.com or contact:

Communications & Media:
Kerrie McHugh
Tel: (212) 618-3469
Email: kerrie.mchugh@brookfield.com
  Investor Relations:
Ben Sassi
Tel: (416) 369-5722
Email: ben.sassi@brookfield.com
     

Non-GAAP and Performance Measures

This news release and accompanying financial statements are based on US GAAP, unless otherwise noted.

We make reference to Distributable operating earnings. We define distributable operating earnings as net income after applicable taxes excluding the impact of depreciation and amortization, deferred income taxes related to basis and other changes, and breakage and transaction costs, as well as certain investment and insurance reserve gains and losses, including gains and losses related to asset and liability matching strategies, non-operating adjustments related to changes in cash flow assumptions for future policy benefits, and change in market risk benefits, and is inclusive of returns on equity invested in certain variable interest entities and our share of adjusted earnings from our investments in certain associates. Distributable operating earnings is a measure of operating performance. We use distributable operating earnings to assess our operating results.

We provide additional information on key terms and non-GAAP measures in our filings available at bnt.brookfield.com.

Notice to Readers

Brookfield Wealth Solutions Ltd. (“Brookfield Wealth Solutions” or “our” or “we”) is not making any offer or invitation of any kind by communication of this news release and under no circumstances is it to be construed as a prospectus or an advertisement.

This news release contains “forward-looking information” within the meaning of Canadian provincial securities laws, “forward-looking statements” within the meaning of Canadian provincial securities laws, “forward-looking statements” within the meaning of the U.S. Securities Act of 1933, the U.S. Securities Exchange Act of 1934, and “safe harbor” provisions of the United States Private Securities Litigation Reform Act of 1995 and in any applicable Canadian securities regulations (collectively, “forward-looking statements”). Forward-looking statements include statements that are predictive in nature, depend upon or refer to future results, events or conditions, and include, but are not limited to, statements which reflect management’s current estimates, assumptions and expectations regarding the operations, business, financial condition, expected financial results, performance, prospects, opportunities, priorities, targets, goals, ongoing objectives, strategies, capital management and outlook of Brookfield Wealth Solutions, Brookfield Corporation and their respective subsidiaries, as well as the outlook for North American and international economies for the current fiscal year and subsequent periods. In particular, the forward-looking statements contained in this news release include statements referring to the growth of our business, international expansion, investment opportunities, expected future deployment of capital and financial earnings and all statements relating to the proposed Transaction and its expected impact on our business. In some cases, forward-looking statements can be identified by the use of forward-looking terminology such as “expects,” “anticipates,” “plans,” “believes,” “estimates,” “seeks,” “intends,” “targets,” “projects,” “foresees,” “forecasts” or negative versions thereof and other similar expressions, or future or conditional verbs such as “may,” “will,” “should,” “would” and “could.” Although we believe that our anticipated future results, performance or achievements expressed or implied by the forward-looking statements and information are based upon reasonable estimates, assumptions and expectations, the reader should not place undue reliance on forward-looking statements and information because they involve known and unknown risks, uncertainties and other factors, many of which are beyond our control, which may cause the actual results, performance or achievements of Brookfield Wealth Solutions or Brookfield Corporation to differ materially from anticipated future results, performance or achievement expressed or implied by such forward-looking statements and information.

Factors that could cause actual results to differ materially from those contemplated or implied by forward-looking statements include, but are not limited to: (i) investment returns that are lower than target; (ii) the impact or unanticipated impact of general economic, political and market factors in the countries in which we do business; (iii) the behavior of financial markets, including fluctuations in interest and foreign exchange rates and heightened inflationary pressures; (iv) global equity and capital markets and the availability of equity and debt financing and refinancing within these markets; (v) strategic actions including acquisitions and dispositions; and the ability to complete and effectively integrate acquisitions into existing operations and the ability to attain expected benefits; (vi) changes in accounting policies and methods used to report financial condition (including uncertainties associated with critical accounting assumptions and estimates); (vii) the ability to appropriately manage human capital; (viii) the effect of applying future accounting changes; (ix) business competition; (x) operational and reputational risks; (xi) technological change; (xii) changes in government regulation and legislation within the countries in which we operate; (xiii) governmental investigations and sanctions; (xiv) litigation; (xv) changes in tax laws; (xvi) ability to collect amounts owed; (xvii) catastrophic events, including but not limited to, earthquakes, hurricanes, epidemics and pandemics; (xviii) the possible impact of international conflicts and other developments including terrorist acts and cyberterrorism; (xix) the introduction, withdrawal, success and timing of business initiatives and strategies; (xx) the failure of effective disclosure controls and procedures and internal controls over financial reporting and other risks; (xxi) health, safety and environmental risks; (xxii) the maintenance of adequate insurance coverage; (xxiii) the existence of information barriers between certain businesses within our asset management operations; (xxiv) risks specific to our business segments; and (xxv) factors detailed from time to time in our documents filed with the securities regulators in Canada and the United States.

We caution that the foregoing list of important factors that may affect future results is not exhaustive and other factors could also adversely affect our results. Readers are urged to consider the foregoing risks, as well as other uncertainties, factors and assumptions carefully in evaluating the forward-looking information and are cautioned not to place undue reliance on such forward-looking information. Except as required by law, Brookfield Wealth Solutions undertakes no obligation to publicly update or revise any forward-looking statements or information, whether written or oral, that may be as a result of new information, future events or otherwise.

Past performance is not indicative of or a guarantee of future results. There can be no assurance that comparable results will be achieved in the future, that future investments will be similar to the historic investments discussed herein, that targeted returns, growth objectives, diversification or asset allocations will be met or that an investment strategy or investment objectives will be achieved (because of economic conditions, the availability of investment opportunities or otherwise).

Certain of the information contained herein is based on or derived from information provided by independent third-party sources. While Brookfield Wealth Solutions believes that such information is accurate as of the date it was produced and that the sources from which such information has been obtained are reliable, Brookfield Wealth Solutions does not make any assurance, representation or warranty, express or implied, with respect to the accuracy, reasonableness or completeness of any of the information or the assumptions on which such information is based, contained herein, including but not limited to, information obtained from third parties, and undue reliance should not be put on them.

No statements contained herein with respect to tax consequences are intended to be, or should be construed to be, legal or tax advice, and no representation is made with respect to tax consequences. Shareholders are urged to consult their legal and tax advisors with respect to their circumstances.

Privacy Overview

This website uses cookies so that we can provide you with the best user experience possible. Cookie information is stored in your browser and performs functions such as recognising you when you return to our website and helping our team to understand which sections of the website you find most interesting and useful.