Recognized First HPC Lease Revenue 

Expanded Barber Lake Lease Term to 20 Years, Increasing Contracted Revenue to $9.1 Billion

Received Conditional Base Load Classification for Colchis (1 GW)

Began Development of Lateral Pipelines to Facilitate up to 2.5 GW of On-Site Generation for Data Center Expansion

NEW YORK, Nov. 02, 2026 (GLOBE NEWSWIRE) — Cipher Digital Inc. (NASDAQ: CIFR) (“Cipher” or the “Company”), a leading developer, owner, and operator of industrial-scale data centers, today announced its third quarter 2026 financial results, with an update on its operations and business strategy.

The third quarter marked a milestone in Cipher’s transition to a leading HPC development platform, as the Company recognized its first HPC lease revenue following rent commencement at Black Pearl. Across Black Pearl and Barber Lake, multiple data halls are scheduled to come online through year-end.

Cipher also highlighted its previously announced amendment to the Barber Lake lease, which adds a second 10-year term directly with a leading AI lab. The amendment increases total contracted revenue at the site to approximately $9.1 billion, adding approximately $5.2 billion of incremental rent. It also establishes a phased delivery schedule aligned with the tenant’s compute deployment, and construction remains on track to deliver against the amended schedule.

In the third quarter, the Company received conditional classifications across several pipeline sites through ERCOT’s Batch Zero process, including a conditional base load classification for 1 GW at Colchis and conditional studied load classifications with Provisional Controllable Load Resource (“PCLR”) designations for an additional 1.6 GW.

The Company also commenced development of lateral natural gas pipelines capable of supporting up to 2.5 GW of on-site generation, and acquired Horizon, a 70 MW site in Texas expected to energize in 2029. The pipeline also includes 270 MW of capacity available in 2027, for which the Company continues to advance tenant discussions and design work. Cipher’s development pipeline today totals approximately 5.9 GW.

“Cipher was built for this market, and this quarter we took important steps to strengthen our position for the long term,” said Tyler Page, Chief Executive Officer. “The decisions we made early on about who we partner with, how we structure our projects, how we navigate a dynamic regulatory environment and how we engage with our communities were made for exactly these conditions. Demand for compute is growing, and our relationships with leading hyperscalers and AI labs are deepening. We are adding new capacity to our pipeline, investing earlier in every project and advancing design work before committing to new leases, so we are well positioned for our next phase of growth.”

Finance and Operations Highlights

  • Recognized first HPC lease revenue
  • Delivered first capacity at Black Pearl with additional capacity across all three campuses expected to come online in phases over the coming months
  • Expanded the Barber Lake lease to a 20-year term, increasing total contracted revenue at the site to approximately $9.1 billion
  • Acquired Horizon, a 70 MW Site in Texas with energization expected in 2029
  • Completed an $850 million offering of 0.000% convertible senior notes due 2032, funding additional equity investment into Barber Lake in connection with the lease expansion, with associated capped call transactions raising the effective conversion price to $28.35 per share
  • Equitized approximately $165.9 million of the 1.750% convertible notes due 2030, retiring more than 90% of those notes
  • Received a conditional base load classification for 1 GW and conditional studied load classifications for 1.6 GW with PCLR designations, through ERCOT’s Batch Zero process
  • Commenced development of lateral pipelines to support up to 2.5 GW of potential on-site generation across multiple sites
  • Barber Lake data center construction on track to meet the amended milestones
  • Black Pearl data center continues to progress towards completion with ongoing equipment installation and energization across various data halls
  • Stingray construction advancing, with steel erection progressing on schedule and shell construction expected to be completed in the fourth quarter
  • Q3 2026 Revenue of $27 million and Adjusted EBITDA of negative $10 million

Business Update Call and Webcast

The live webcast and a webcast replay of the conference call can be accessed from the investor relations section of Cipher’s website at https://investors.cipherdigital.com/.

About Cipher

Cipher develops and operates industrial-scale data centers engineered for next-generation computing at the highest standards of innovation, precision, and excellence. The Company brings together deep expertise across power sourcing, construction, engineering, operations, real estate, and technology to deliver high-quality data centers purpose built for HPC workloads. By partnering with premier tenants, Cipher seeks to meet the growing demand for industrial-scale data center capacity and become a leading HPC development platform that is built for hyperscale. To learn more about Cipher, please visit https://www.cipherdigital.com/.

Forward Looking Statements

This press release contains certain forward-looking statements within the meaning of the federal securities laws of the United States. The Company intends such forward-looking statements to be covered by the safe harbor provisions for forward-looking statements contained in the Private Securities Litigation Reform Act of 1995 and includes this statement for purposes of complying with these safe harbor provisions. Any statements made in this press release that are not statements of historical fact, such as, statements about the Company’s beliefs and expectations regarding its future results of operations and financial position, its planned business model and strategy, its data center development, timing and likelihood of success, capacity, functionality and timing of operation of data centers, expectations regarding the operations of data centers, potential strategic initiatives, such as joint ventures and partnerships, and management plans and objectives, are forward-looking statements and should be evaluated as such. These forward-looking statements generally are identified by the words “may,” “will,” “should,” “expects,” “plans,” “anticipates,” “could,” “seeks,” “intends,” “targets,” “projects,” “contemplates,” “believes,” “estimates,” “strategy,” “future,” “forecasts,” “opportunity,” “predicts,” “potential,” “would,” “will likely result,” “continue,” and similar expressions (including the negative versions of such words or expressions).

These forward-looking statements are based upon estimates and assumptions that, while considered reasonable by Cipher and its management, are inherently uncertain. Such forward-looking statements are subject to risks, uncertainties, and other factors that could cause actual results to differ materially from those expressed or implied by such forward-looking statements. New risks and uncertainties may emerge from time to time, and it is not possible to predict all risks and uncertainties. Many factors could cause actual future events to differ materially from the forward-looking statements in this press release, including but not limited to: volatility in the price of Cipher’s securities due to a variety of factors, including changes in the competitive and regulated industry in which Cipher operates, Cipher’s evolving business model and strategy and efforts it may make to modify aspects of its business model or engage in various strategic initiatives, variations in performance across competitors, changes in laws and regulations affecting Cipher’s business, the ability of Cipher’s customers, tenants, and other counterparties to perform their contractual obligations, the ability to Cipher to complete its data centers and future strategic growth initiatives in a timely manner or within anticipated cost estimates, risks relating to the development, construction, and operation of Cipher’s data centers, the availability of capital and financing on acceptable terms, changes in market demand, and the ability to implement business plans, forecasts, and other expectations and to identify and realize additional opportunities. The foregoing list of factors is not exhaustive. You should carefully consider the foregoing factors and the other risks and uncertainties described in the “Risk Factors” section of Cipher’s Annual Report on Form 10-K for the fiscal year ended December 31, 2025 filed with the Securities and Exchange Commission (“SEC”) on February 24, 2026, Cipher’s Quarterly Report on Form 10-Q for the quarterly period ended June 30, 2026, filed with the SEC on August 4, 2026, Cipher’s Quarterly Report on Form 10-Q for the quarterly period ended September 30, 2026 to be filed with the SEC and in Cipher’s subsequent filings with the SEC. These filings identify and address other important risks and uncertainties that could cause actual events and results to differ materially from those contained in the forward-looking statements. Forward-looking statements speak only as of the date they are made. Readers are cautioned not to put undue reliance on forward-looking statements, and Cipher assumes no obligation and, except as required by law, does not intend to update or revise these forward-looking statements, whether as a result of new information, future events, or otherwise.

Website Disclosure

The Company maintains a dedicated investor website at https://investors.cipherdigital.com/investors (“Investors’ Website”). Financial and other important information regarding the Company is routinely posted on and accessible through the Investors Website. Cipher uses its Investors’ Website as a distribution channel of material information about the Company, including through press releases, investor presentations, reports and notices of upcoming events. Cipher intends to utilize its Investors’ Website as a channel of distribution to reach public investors and as a means of disclosing material non-public information for complying with disclosure obligations under Regulation FD. In addition, you may sign up to automatically receive email alerts and other information about the Company by visiting the “Email Alerts” option under the Investors Resources section of Cipher’s Investors’ Website and submitting your email address.

Non-GAAP Financial Measures

This press release includes supplemental financial measures Adjusted EBITDA, that excludes the impact of (i) interest income, (ii) interest expense, (iii) income taxes, (iv) depreciation and amortization, (v) the non-cash change in fair value of derivative asset, (vi) share-based compensation expense, (vii) nonrecurring gains and losses, (viii) the non-cash change in fair value of warrant liability, (ix) non-cash losses related to miners reclassified as held for sale, (x) impairment of long-lived assets, and (xi) non-cash disposal of miners.

Beginning with the three months ended March 31, 2026, the Company changed its primary non-GAAP performance from “Adjusted Earnings (Loss)” to Adjusted EBITDA. Adjusted EBITDA differs from Adjusted Earnings (Loss) only in that, in addition to the adjustments previously made to compute Adjusted Earnings (Loss), Adjusted EBITDA also excludes interest expense, interest income, and current income tax expense. We believe Adjusted EBITDA is more representative of the Company’s core operating performance, more comparable to measures used by industry peers, and more useful to investors evaluating our underlying business. The reconciliation table below presents Adjusted EBITDA for both periods presented under the Company’s new methodology. The Company does not intend to report Adjusted Earnings (Loss) in future periods.

These supplemental financial measures are not measurements of financial performance under accounting principles generally accepted in the United States (“GAAP”) and, as a result, these supplemental financial measures may not be comparable to similarly titled measures of other companies. Management uses these non-GAAP financial measures internally to help understand, manage, and evaluate our business performance and to help make operating decisions. We believe the use of these non-GAAP financial measures can also facilitate comparison of our operating results to those of our competitors by excluding certain items that vary in our industry based on company policy.

Non-GAAP financial measures are subject to material limitations as they are not in accordance with, or a substitute for, measurements prepared in accordance with GAAP. For example, we expect that share-based compensation expense, which is excluded from the non-GAAP financial measure, will continue to be a significant recurring expense over the coming years and is an important part of the compensation provided to certain employees, officers and directors. Similarly, we expect that depreciation and amortization will continue to be a recurring expense over the term of the useful life of the related assets. Our non-GAAP financial measures are not meant to be considered in isolation and should be read only in conjunction with our condensed consolidated financial statements, which have been prepared in accordance with GAAP. We rely primarily on such condensed consolidated financial statements to understand, manage and evaluate our business performance and use the non-GAAP financial measures only supplementally.

Contacts:

Investor Contact:
Courtney Knight
Head of Investor Relations
courtney.knight@cipherdigital.com

Media Contact:
Ryan Dicovitsky
Dukas Linden Public Relations
CipherDigital@DLPR.com

 
CIPHER DIGITAL INC.
CONDENSED CONSOLIDATED BALANCE SHEETS
(in thousands, except for share and per share amounts)
(unaudited)
       
  September 30, 2026   December 31, 2025
ASSETS      
Current assets      
Cash and cash equivalents $ 656,009     $ 628,263  
Restricted cash, current   1,719,403       1,761,292  
Accounts receivable   20,469       687  
Receivables, related party   –       271  
Prepaid expenses and other current assets   56,342       7,977  
Bitcoin   25,943       125,400  
Miners held for sale   –       94,879  
Derivative asset, current   8,770       34,090  
Total current assets   2,486,936       2,652,859  
Restricted cash, non-current   477,182       275,076  
Property and equipment, net   3,899,880       633,417  
Intangible assets, net   125,094       77,388  
Investment in equity investees   –       29,400  
Derivative asset, non-current   –       22,720  
Operating lease right-of-use asset   32,322       11,321  
Security deposits   89,565       27,732  
Other non-current assets   555,075       561,995  
Total assets $ 7,666,054     $ 4,291,908  
LIABILITIES, REDEEMABLE NONCONTROLLING INTEREST, AND STOCKHOLDERS’ EQUITY      
Current liabilities      
Accounts payable $ 216,987     $ 40,064  
Accrued expenses and other current liabilities   628,770       90,086  
Finance lease liability, current portion   4,389       4,237  
Operating lease liability, current portion   2,450       1,731  
Warrant liability   504,880       525,160  
Short-term borrowings   112,704       37,793  
Total current liabilities   1,470,180       699,071  
Deferred revenue   46,185       –  
Long-term borrowings, net   5,447,174       2,711,648  
Asset retirement obligations   24,082       33,696  
Finance lease liability   17,930       3,094  
Operating lease liability   34,578       8,545  
Total liabilities   7,040,129       3,456,054  
Commitments and contingencies (Note 13)      
Redeemable noncontrolling interest   25,670       30,319  
Stockholders’ equity      
Preferred stock, $0.001 par value; 10,000,000 shares authorized, none issued and outstanding as of September 30, 2026, and December 31, 2025   –       –  
Common stock, $0.001 par value, 1,000,000,000 and 1,000,000,000 shares authorized as of September 30, 2026 and December 31, 2025, respectively, 425,237,783 and 412,074,529 shares issued as of September 30, 2026 and December 31, 2025, respectively, and 415,092,825 and 404,963,061 shares outstanding as of September 30, 2026, and December 31, 2025, respectively   425       412  
Additional paid-in capital   1,953,736       1,808,786  
Accumulated deficit   (1,353,896 )     (1,003,656 )
Treasury stock, at par, 10,144,958 and 7,111,468 shares at September 30, 2026 and December 31, 2025, respectively   (10 )     (7 )
Total stockholders’ equity   600,255       805,535  
Total liabilities, redeemable noncontrolling interest, and stockholders’ equity $ 7,666,054     $ 4,291,908  
               


CIPHER DIGITAL INC.
CONDENSED CONSOLIDATED STATEMENTS OF OPERATIONS
(in thousands, except for share and per share amounts)
(unaudited)
       
  Three Months Ended
September 30,
  Nine Months Ended
September 30,
  2026   2025   2026   2025
Revenue – bitcoin mining $ 20,849     $ 71,707     $ 80,524     $ 164,231  
Revenue – HPC leasing   5,852       –       5,852       –  
Total revenue   26,701       71,707       86,376       164,231  
Costs and operating (expenses) income              
Cost of revenue – bitcoin mining   (14,638 )     (26,733 )     (46,487 )     (56,957 )
Cost of revenue – HPC leasing   (726 )     –       (1,629 )     –  
Compensation and benefits   (38,555 )     (14,445 )     (115,917 )     (44,407 )
General and administrative   (26,359 )     (8,167 )     (54,578 )     (26,196 )
Depreciation and amortization   (18,821 )     (59,549 )     (57,200 )     (147,102 )
Change in fair value of power purchase agreement   (13,910 )     (9,030 )     (48,040 )     (17,180 )
Power sales   4,251       2,335       8,684       4,702  
Equity in losses of equity investees   –       (1,479 )     (1,601 )     (8,472 )
Unrealized gains (losses) on fair value of bitcoin   12,394       108       33,055       (2,927 )
Realized gains (losses) on sale of bitcoin   481       7,535       (47,251 )     16,092  
Other operating income (losses)   (2,733 )     101       (20,432 )     (2,732 )
Total costs and operating expenses   (98,616 )     (109,324 )     (351,396 )     (285,179 )
Operating loss   (71,915 )     (37,617 )     (265,020 )     (120,948 )
Other income (expense)              
Interest income   32,684       457       100,135       943  
Interest expense   (58,994 )     (1,286 )     (184,888 )     (3,200 )
Change in fair value of warrant liability   127,180       31,860       20,280       31,860  
Other income (expenses)   2,587       3,000       (20,036 )     4,064  
Total other income (expense)   103,457       34,031       (84,509 )     33,667  
Income (loss) before taxes   31,542       (3,586 )     (349,529 )     (87,281 )
Current income tax benefit (expense)   54       767       (720 )     (1,157 )
Deferred income tax (expense) benefit   –       (464 )     –       399  
Total income tax benefit (expense)   54       303       (720 )     (758 )
Net income (loss)   31,596       (3,283 )     (350,249 )     (88,039 )
Less: Net loss attributable to redeemable noncontrolling interest   9       –       9       –  
Net income (loss) available for common stockholders $ 31,605     $ (3,283 )   $ (350,240 )   $ (88,039 )
Earnings (loss) per share – basic $ 0.08     $ (0.01 )   $ (0.85 )   $ (0.23 )
Earnings (loss) per share – diluted $ (0.22 )   $ (0.01 )   $ (0.85 )   $ (0.23 )
Weighted average shares outstanding – basic   414,996,770       393,191,623       409,866,599       376,372,526  
Weighted average shares outstanding – diluted   439,694,022       393,191,623       409,866,599       376,372,526  
                               

Non-GAAP Financial Measures

The following is a reconciliation of our Adjusted EBITDA, which excludes the impact of (i) interest income, (ii) interest expense, (iii) income taxes, (iv) depreciation and amortization, (v) the non-cash change in fair value of derivative asset, (vi) share-based compensation expense, (vii) nonrecurring gains and losses, (viii) the non-cash change in fair value of warrant liability, (ix) non-cash losses related to miners reclassified as held for sale, (x) impairment of long-lived assets, and (xi) non-cash disposal of miners, to the most directly comparable GAAP measure for the periods indicated (in thousands).

  Three Months Ended
September 30,
  Nine Months Ended
September 30,
  2026   2025   2026   2025
Reconciliation of Adjusted EBITDA:              
Net income (loss) $ 31,596     $ (3,283 )   $ (350,249 )   $ (88,039 )
Interest income   (32,684 )     (457 )     (100,135 )     (943 )
Interest expense   58,994       1,286       184,888       3,200  
Total income tax expense   (54 )     (303 )     720       758  
Depreciation and amortization   18,821       59,549       57,200       147,102  
EBITDA $ 76,673     $ 56,792     $ (207,576 )   $ 62,078  
Change in fair value of power purchase agreement   13,910       9,030       48,040       17,180  
Share-based compensation expense   26,634       9,074       84,208       28,736  
Other (gains) losses – nonrecurring   —       (2,246 )     —       4,049  
Change in fair value of warrant liability   (127,180 )     (31,860 )     (20,280 )     (31,860 )
Loss on miners held for sale   —       —       7,437       —  
Adjusted EBITDA $ (9,963 )   $ 40,790     $ (88,171 )   $ 80,183  

  • Trial met its dual primary endpoints for (1) statistically significant reduction (p=0.0168) in microglial activation as measured by TSPO PET imaging in patients treated with 50 ug nasal foralumab as compared to placebo and (2) safety/tolerability.
  • Foralumab-treated subjects showed statistically significant and clinically significant improvements in Modified Fatigue Impact Scale (MFIS) scores compared with their own baseline scores after only 12 weeks of drug therapy. Subjects treated with 50 ug nasal foralumab saw a -6.17 point decrease from baseline (p=0.035), and those treated with 100 ug experienced a -7.18 decrease from baseline (p=0.040). No significant change was seen in the placebo group.

BOSTON, Nov. 02, 2026 (GLOBE NEWSWIRE) — Tiziana Life Sciences, Ltd. (Nasdaq: TLSA) (“Tiziana” or the “Company”), a biotechnology company developing breakthrough immunomodulation therapies with its lead development candidate, intranasal foralumab, a fully human anti-CD3 monoclonal antibody, today announced positive topline data in its Phase 2a INFORM-MS trial with intranasal foralumab (a human, anti-CD3 monoclonal antibody) in patients with non-active secondary progressive multiple sclerosis (na-SPMS).

Non-active secondary progressive MS is a form of the disease characterized by gradual accumulation of disability independent of relapses. There are currently no FDA-approved therapies specifically indicated for na-SPMS, leaving patients with a significant unmet need, particularly related to progressive disability and fatigue.

The randomized, double-blind, placebo-controlled trial met its dual primary endpoints. Firstly, there was a statistically significant reduction in neuroinflammation (as measured by a reduction in microglial activation with[¹⁸F]PBR06 TSPO PET imaging), (p=0.0168) after 12 weeks of treatment between the 50 ug nasal foralumab treatment arm and placebo. Second, both 50 μg and 100 μg doses of intranasal foralumab were safe and well-tolerated.

The average fatigue scores improved by more than 4 points in both the 50 μg and 100 μg treatment arms, between baseline and Week 12, representing a clinically significant (Rooney et al., 2019) reduction of fatigue as measured by the Modified Fatigue Impact Scale (MFIS). The MFIS Total Score showed a numerical mean change of –6.17 in the 50 μg arm, –7.18 in the 100 μg arm compared with –3.12 in the placebo arm, representing a clinically significant improvement of more than 4 points within the treatment arms. These reductions were statistically significant compared with each treatment group’s own baseline scores [50 μg dose arm (p=0.035) and 100 μg dose arm (p=0.040)]. We did not see any changes in the EDSS secondary endpoint over the 3-month treatment duration.

“These results represent a significant milestone for patients with non-active secondary progressive MS, a population with significant unmet need and limited treatment options,” said Tanuja Chitnis, M.D., Principal Investigator of the INFORM-MS trial and Professor of Neurology at Harvard Medical School / Brigham and Women’s Hospital. “The primary imaging endpoint on TSPO PET in the 50 ug nasal foralumab treatment arm from the INFORM-MS study closely mirrors the reductions in microglial activation we previously published in our expanded access program, providing important corroboration in a controlled setting. Equally encouraging is the clinically significant improvement in fatigue as measured by MFIS, despite the short 12-week treatment duration. This clinical effect was notable. We consider these findings as encouraging evidence of the biological activity of nasal foralumab in this MS population where at present there are no approved treatments for these patients. Safety and tolerability were favorable across both doses.”

“These positive topline results from INFORM-MS further validate the therapeutic potential of intranasal foralumab in non-active secondary progressive MS,” said Tarun Singhal, MBBS, M.D., M.B.A., Founding Director, NeuroPET Program, Ann Romney Center for Neurologic Diseases, Brigham and Women’s Hospital, Mass General Brigham and Associate Professor of Neurology at Harvard Medical School. “Seeing a statistically significant reduction in microglial activation on TSPO PET, together with a clinically significant difference in fatigue in both foralumab doses, is highly encouraging. These findings align with what we have observed in the expanded access setting and reinforce the rationale for advancing this novel approach.”

Ivor Elrifi, Chief Executive Officer of Tiziana Life Sciences, commented: “We are extremely pleased that INFORM-MS successfully met its primary endpoints for both safety and reduction in neuroinflammation measured by PET imaging of microglial activation. The statistically significant, and clinically significant improvements from baseline in MFIS at both 50 μg and 100 μg doses further strengthens our conviction in the potential of intranasal foralumab. These data, together with the accumulating real-world evidence from our expanded access program in na-SPMS patients, as well as emerging data from our current trials in AD, ALS, and MSA, positions us well as we advance foralumab to the next stage of development. We would like to express our sincere gratitude to the investigators, clinical site staff, and most importantly the patients and their families who participated in the INFORM-MS trial. Their commitment and partnership made this important study possible, and we deeply appreciate their contributions to advancing potential new treatment options for people living with non-active secondary progressive MS.”

Tiziana developed nasal foralumab for the treatment of neurologic diseases, based on discoveries in the laboratory of Howard L. Weiner, MD, Professor of Neurology at the Harvard Medical School and Co-Director of the Ann Romney Center for Neurologic Diseases at the Brigham and Women’s Hospital.

INFORM-MS enrolled patients across 8 clinical sites in the United States. Participants were randomized to receive placebo (n=18), intranasal foralumab 50 μg (n=19), or intranasal foralumab 100 μg (n=11). Treatment was 12 weeks of dosing delivered in four consecutive three-week cycles. Primary endpoints were safety / tolerability, and change from baseline in microglial activation measured by [¹⁸F]PBR06 TSPO PET. Secondary endpoints included the Modified Fatigue Impact Scale (MFIS) and Expanded Disability Status Scale (EDSS).

Primary Endpoints –Microglial Activation (TSPO PET) and Safety

The trial met its neuroinflammation endpoint (measured by TSPO-PET) in patients treated with 50 µg nasal foralumab. In an ANCOVA, assessing all patients who had analyzable PET scans (n=40), adjusting for baseline white-matter/global-brain SUV ratio (SUVR), TSPO binding affinity, baseline Expanded Disability Status Scale (EDSS), timed 25-foot walk (T25FW), recruiting center, and scanner-pair category, the globally normalized White Matter SUVR adjusted treatment difference was -0.0231 (-0.0416 to -0.0046 95% CI), and reached statistical significance (p=0.0168). The 50 µg finding was also significant in the model without EDSS and T25FW adjustment (p = 0.0394). The change in microglial activation mirrored previously published findings from foralumab expanded access program (Chitnis et al., 2026), corroborating the placebo-controlled observations. There was no statistically significant difference in PET over the treatment period in patients treated with 100 µg nasal foralumab (n=11).

The trial also met its primary safety objectives. Foralumab administered as a nasal spray was well tolerated across both dose levels studied. All 48 participants completed treatment and there were no deaths, no discontinuations due to adverse events, or no study-drug related SAEs. Treatment-emergent adverse events occurred in 15/18 (83.3%) of placebo patients and 23/30 (76.7%) of foralumab-treated patients (50 μg and 100 μg combined). The most common treatment-emergent adverse events reported in ≥10% of patients in either foralumab group were headache, fall, nasal congestion, and rhinorrhea.

Secondary Endpoints

This study was not powered to demonstrate definitive changes in clinical parameters such as fatigue (which is a hallmark of the disease). Nonetheless the MFIS Total Score showed a numerical mean change of –6.17 in the 50 μg arm, –7.18 in the 100 μg arm compared with –3.12 in the placebo arm, representing a clinically significant improvement of more than 4 points in each foralumab arm. The approximately twofold greater improvement observed in both foralumab groups supports the totality of evidence that this change is clinically significant, consistent with previous published data from the expanded access program (Chitnis et al., 2026). In addition, the data showed a statistically significant reduction (p=0.035) within the 50 μg dose arm and (p=0.040) within the 100 μg arm in MFIS between baseline and 12-week treatment duration.

Next Steps
Tiziana intends to complete full analysis of the INFORM-MS data set and present the detailed results at an upcoming relevant scientific congress. The Company also plans to engage with the U.S. Food and Drug Administration to discuss the results and the potential path forward for further clinical development of intranasal foralumab in na-SPMS.

About Non-Active Secondary Progressive Multiple Sclerosis
Non-active secondary progressive MS is characterized by gradual accumulation of disability without recent relapses or new MRI activity. Microglial activation is believed to play a central role in the progressive biology of the disease. Current treatment options remain limited.

About Foralumab
Foralumab, a fully human anti-CD3 monoclonal antibody, is a biological drug candidate that has been shown to stimulate T regulatory cells when dosed intranasally. At present, 14 patients with Non-Active Secondary Progressive Multiple Sclerosis (na-SPMS) have been dosed in an open-label intermediate sized Expanded Access (EA) Program (NCT06802328) with either an improvement or stability of disease seen within 6 months in all patients. Intranasal foralumab is also currently being studied in additional Phase 2 trials in AD, ALS, and MSA.

Intranasal foralumab is the only fully human anti-CD3 monoclonal antibody (mAb) currently in clinical development. Immunomodulation by intranasal foralumab represents a novel avenue for the treatment of neuroinflammatory and neurodegenerative human diseases.[1],[2]

About Tiziana Life Sciences

Tiziana Life Sciences is a clinical-stage biopharmaceutical company developing breakthrough therapies using transformational drug delivery technologies to enable alternative routes of immunotherapy. Tiziana’s innovative intranasal approach has the potential to provide an improvement in efficacy as well as safety and tolerability compared to intravenous (IV) delivery. Tiziana’s lead candidate, intranasal foralumab, which is the only fully human anti-CD3 mAb currently in clinical development, has demonstrated a favorable safety profile and clinical response in patients in studies to date. Tiziana’s technology for alternative routes of immunotherapy has been patented with several applications pending and is expected to allow for broad pipeline applications.

For more information about Tiziana Life Sciences and its innovative pipeline of therapies, please visit www.tizianalifesciences.com.

Forward-Looking Statements

Statements in this press release may be “forward-looking statements” within the meaning of Section 27A of the U.S. Securities Act of 1933, as amended, and Section 21E of the U.S. Securities Exchange Act of 1934, as amended, that concern matters that involve risks and uncertainties that could cause actual results to differ materially from those anticipated or projected in the forward-looking statements. These forward-looking statements are not historical facts but rather are based on the Company’s current expectations, estimates, and projections about its industry; its beliefs; and assumptions. Words such as ‘anticipates,’ ‘expects,’ ‘intends,’ ‘plans,’ ‘believes,’ ‘seeks,’ ‘estimates,’ and similar expressions are intended to identify forward-looking statements. These forward-looking statements reflect the current beliefs and expectations of Tiziana’s management and statements regarding completion of the INFORM-MS data analysis, presentation of detailed results, engagement with the FDA and potential further clinical development of intranasal foralumab. These statements are not guarantees of future performance and are subject to known and unknown risks, uncertainties, and other factors, some of which are beyond the Company’s control, are difficult to predict, and could cause actual results to differ materially from those expressed or forecasted in the forward-looking statements. The Company cautions security holders and prospective security holders not to place undue reliance on these forward-looking statements, which reflect the view of the Company only as of the date of this announcement. Actual results may differ materially from those indicated by such forward-looking statements as a result of various important factors, including: the uncertainties related to market conditions and other factors described more fully in the section entitled ‘Risk Factors’ in Tiziana’s Annual Report on Form 20-F for the year ended December 31, 2025, and other periodic reports filed with the SEC from time to time. The forward-looking statements made in this announcement relate only to events as of the date on which the statements are made. The Company will not undertake any obligation to release publicly any revisions or updates to these forward-looking statements to reflect events, circumstances, or unanticipated events occurring after the date of this announcement except as required by law or by any appropriate regulatory authority.

For further inquiries:

Tiziana Life Sciences Ltd
Paul Spencer, Business Development, and Investor Relations
+44 (0) 207 495 2379
email: info@tizianalifesciences.com

[1] https://www.pnas.org/doi/10.1073/pnas.2220272120

[2] https://www.pnas.org/doi/10.1073/pnas.2309221120

  • Trial met its dual primary endpoints for (1) statistically significant reduction (p=0.0168) in microglial activation as measured by TSPO PET imaging in patients treated with 50 ug nasal foralumab as compared to placebo and (2) safety/tolerability.
  • Foralumab-treated subjects showed statistically significant and clinically significant improvements in Modified Fatigue Impact Scale (MFIS) scores compared with their own baseline scores after only 12 weeks of drug therapy. Subjects treated with 50 ug nasal foralumab saw a -6.17 point decrease from baseline (p=0.035), and those treated with 100 ug experienced a -7.18 decrease from baseline (p=0.040). No significant change was seen in the placebo group.

BOSTON, Nov. 02, 2026 (GLOBE NEWSWIRE) — Tiziana Life Sciences, Ltd. (Nasdaq: TLSA) (“Tiziana” or the “Company”), a biotechnology company developing breakthrough immunomodulation therapies with its lead development candidate, intranasal foralumab, a fully human anti-CD3 monoclonal antibody, today announced positive topline data in its Phase 2a INFORM-MS trial with intranasal foralumab (a human, anti-CD3 monoclonal antibody) in patients with non-active secondary progressive multiple sclerosis (na-SPMS).

Non-active secondary progressive MS is a form of the disease characterized by gradual accumulation of disability independent of relapses. There are currently no FDA-approved therapies specifically indicated for na-SPMS, leaving patients with a significant unmet need, particularly related to progressive disability and fatigue.

The randomized, double-blind, placebo-controlled trial met its dual primary endpoints. Firstly, there was a statistically significant reduction in neuroinflammation (as measured by a reduction in microglial activation with[¹⁸F]PBR06 TSPO PET imaging), (p=0.0168) after 12 weeks of treatment between the 50 ug nasal foralumab treatment arm and placebo. Second, both 50 μg and 100 μg doses of intranasal foralumab were safe and well-tolerated.

The average fatigue scores improved by more than 4 points in both the 50 μg and 100 μg treatment arms, between baseline and Week 12, representing a clinically significant (Rooney et al., 2019) reduction of fatigue as measured by the Modified Fatigue Impact Scale (MFIS). The MFIS Total Score showed a numerical mean change of –6.17 in the 50 μg arm, –7.18 in the 100 μg arm compared with –3.12 in the placebo arm, representing a clinically significant improvement of more than 4 points within the treatment arms. These reductions were statistically significant compared with each treatment group’s own baseline scores [50 μg dose arm (p=0.035) and 100 μg dose arm (p=0.040)]. We did not see any changes in the EDSS secondary endpoint over the 3-month treatment duration.

“These results represent a significant milestone for patients with non-active secondary progressive MS, a population with significant unmet need and limited treatment options,” said Tanuja Chitnis, M.D., Principal Investigator of the INFORM-MS trial and Professor of Neurology at Harvard Medical School / Brigham and Women’s Hospital. “The primary imaging endpoint on TSPO PET in the 50 ug nasal foralumab treatment arm from the INFORM-MS study closely mirrors the reductions in microglial activation we previously published in our expanded access program, providing important corroboration in a controlled setting. Equally encouraging is the clinically significant improvement in fatigue as measured by MFIS, despite the short 12-week treatment duration. This clinical effect was notable. We consider these findings as encouraging evidence of the biological activity of nasal foralumab in this MS population where at present there are no approved treatments for these patients. Safety and tolerability were favorable across both doses.”

“These positive topline results from INFORM-MS further validate the therapeutic potential of intranasal foralumab in non-active secondary progressive MS,” said Tarun Singhal, MBBS, M.D., M.B.A., Founding Director, NeuroPET Program, Ann Romney Center for Neurologic Diseases, Brigham and Women’s Hospital, Mass General Brigham and Associate Professor of Neurology at Harvard Medical School. “Seeing a statistically significant reduction in microglial activation on TSPO PET, together with a clinically significant difference in fatigue in both foralumab doses, is highly encouraging. These findings align with what we have observed in the expanded access setting and reinforce the rationale for advancing this novel approach.”

Ivor Elrifi, Chief Executive Officer of Tiziana Life Sciences, commented: “We are extremely pleased that INFORM-MS successfully met its primary endpoints for both safety and reduction in neuroinflammation measured by PET imaging of microglial activation. The statistically significant, and clinically significant improvements from baseline in MFIS at both 50 μg and 100 μg doses further strengthens our conviction in the potential of intranasal foralumab. These data, together with the accumulating real-world evidence from our expanded access program in na-SPMS patients, as well as emerging data from our current trials in AD, ALS, and MSA, positions us well as we advance foralumab to the next stage of development. We would like to express our sincere gratitude to the investigators, clinical site staff, and most importantly the patients and their families who participated in the INFORM-MS trial. Their commitment and partnership made this important study possible, and we deeply appreciate their contributions to advancing potential new treatment options for people living with non-active secondary progressive MS.”

Tiziana developed nasal foralumab for the treatment of neurologic diseases, based on discoveries in the laboratory of Howard L. Weiner, MD, Professor of Neurology at the Harvard Medical School and Co-Director of the Ann Romney Center for Neurologic Diseases at the Brigham and Women’s Hospital.

INFORM-MS enrolled patients across 8 clinical sites in the United States. Participants were randomized to receive placebo (n=18), intranasal foralumab 50 μg (n=19), or intranasal foralumab 100 μg (n=11). Treatment was 12 weeks of dosing delivered in four consecutive three-week cycles. Primary endpoints were safety / tolerability, and change from baseline in microglial activation measured by [¹⁸F]PBR06 TSPO PET. Secondary endpoints included the Modified Fatigue Impact Scale (MFIS) and Expanded Disability Status Scale (EDSS).

Primary Endpoints –Microglial Activation (TSPO PET) and Safety

The trial met its neuroinflammation endpoint (measured by TSPO-PET) in patients treated with 50 µg nasal foralumab. In an ANCOVA, assessing all patients who had analyzable PET scans (n=40), adjusting for baseline white-matter/global-brain SUV ratio (SUVR), TSPO binding affinity, baseline Expanded Disability Status Scale (EDSS), timed 25-foot walk (T25FW), recruiting center, and scanner-pair category, the globally normalized White Matter SUVR adjusted treatment difference was -0.0231 (-0.0416 to -0.0046 95% CI), and reached statistical significance (p=0.0168). The 50 µg finding was also significant in the model without EDSS and T25FW adjustment (p = 0.0394). The change in microglial activation mirrored previously published findings from foralumab expanded access program (Chitnis et al., 2026), corroborating the placebo-controlled observations. There was no statistically significant difference in PET over the treatment period in patients treated with 100 µg nasal foralumab (n=11).

The trial also met its primary safety objectives. Foralumab administered as a nasal spray was well tolerated across both dose levels studied. All 48 participants completed treatment and there were no deaths, no discontinuations due to adverse events, or no study-drug related SAEs. Treatment-emergent adverse events occurred in 15/18 (83.3%) of placebo patients and 23/30 (76.7%) of foralumab-treated patients (50 μg and 100 μg combined). The most common treatment-emergent adverse events reported in ≥10% of patients in either foralumab group were headache, fall, nasal congestion, and rhinorrhea.

Secondary Endpoints

This study was not powered to demonstrate definitive changes in clinical parameters such as fatigue (which is a hallmark of the disease). Nonetheless the MFIS Total Score showed a numerical mean change of –6.17 in the 50 μg arm, –7.18 in the 100 μg arm compared with –3.12 in the placebo arm, representing a clinically significant improvement of more than 4 points in each foralumab arm. The approximately twofold greater improvement observed in both foralumab groups supports the totality of evidence that this change is clinically significant, consistent with previous published data from the expanded access program (Chitnis et al., 2026). In addition, the data showed a statistically significant reduction (p=0.035) within the 50 μg dose arm and (p=0.040) within the 100 μg arm in MFIS between baseline and 12-week treatment duration.

Next Steps
Tiziana intends to complete full analysis of the INFORM-MS data set and present the detailed results at an upcoming relevant scientific congress. The Company also plans to engage with the U.S. Food and Drug Administration to discuss the results and the potential path forward for further clinical development of intranasal foralumab in na-SPMS.

About Non-Active Secondary Progressive Multiple Sclerosis
Non-active secondary progressive MS is characterized by gradual accumulation of disability without recent relapses or new MRI activity. Microglial activation is believed to play a central role in the progressive biology of the disease. Current treatment options remain limited.

About Foralumab
Foralumab, a fully human anti-CD3 monoclonal antibody, is a biological drug candidate that has been shown to stimulate T regulatory cells when dosed intranasally. At present, 14 patients with Non-Active Secondary Progressive Multiple Sclerosis (na-SPMS) have been dosed in an open-label intermediate sized Expanded Access (EA) Program (NCT06802328) with either an improvement or stability of disease seen within 6 months in all patients. Intranasal foralumab is also currently being studied in additional Phase 2 trials in AD, ALS, and MSA.

Intranasal foralumab is the only fully human anti-CD3 monoclonal antibody (mAb) currently in clinical development. Immunomodulation by intranasal foralumab represents a novel avenue for the treatment of neuroinflammatory and neurodegenerative human diseases.[1],[2]

About Tiziana Life Sciences

Tiziana Life Sciences is a clinical-stage biopharmaceutical company developing breakthrough therapies using transformational drug delivery technologies to enable alternative routes of immunotherapy. Tiziana’s innovative intranasal approach has the potential to provide an improvement in efficacy as well as safety and tolerability compared to intravenous (IV) delivery. Tiziana’s lead candidate, intranasal foralumab, which is the only fully human anti-CD3 mAb currently in clinical development, has demonstrated a favorable safety profile and clinical response in patients in studies to date. Tiziana’s technology for alternative routes of immunotherapy has been patented with several applications pending and is expected to allow for broad pipeline applications.

For more information about Tiziana Life Sciences and its innovative pipeline of therapies, please visit www.tizianalifesciences.com.

Forward-Looking Statements

Statements in this press release may be “forward-looking statements” within the meaning of Section 27A of the U.S. Securities Act of 1933, as amended, and Section 21E of the U.S. Securities Exchange Act of 1934, as amended, that concern matters that involve risks and uncertainties that could cause actual results to differ materially from those anticipated or projected in the forward-looking statements. These forward-looking statements are not historical facts but rather are based on the Company’s current expectations, estimates, and projections about its industry; its beliefs; and assumptions. Words such as ‘anticipates,’ ‘expects,’ ‘intends,’ ‘plans,’ ‘believes,’ ‘seeks,’ ‘estimates,’ and similar expressions are intended to identify forward-looking statements. These forward-looking statements reflect the current beliefs and expectations of Tiziana’s management and statements regarding completion of the INFORM-MS data analysis, presentation of detailed results, engagement with the FDA and potential further clinical development of intranasal foralumab. These statements are not guarantees of future performance and are subject to known and unknown risks, uncertainties, and other factors, some of which are beyond the Company’s control, are difficult to predict, and could cause actual results to differ materially from those expressed or forecasted in the forward-looking statements. The Company cautions security holders and prospective security holders not to place undue reliance on these forward-looking statements, which reflect the view of the Company only as of the date of this announcement. Actual results may differ materially from those indicated by such forward-looking statements as a result of various important factors, including: the uncertainties related to market conditions and other factors described more fully in the section entitled ‘Risk Factors’ in Tiziana’s Annual Report on Form 20-F for the year ended December 31, 2025, and other periodic reports filed with the SEC from time to time. The forward-looking statements made in this announcement relate only to events as of the date on which the statements are made. The Company will not undertake any obligation to release publicly any revisions or updates to these forward-looking statements to reflect events, circumstances, or unanticipated events occurring after the date of this announcement except as required by law or by any appropriate regulatory authority.

For further inquiries:

Tiziana Life Sciences Ltd
Paul Spencer, Business Development, and Investor Relations
+44 (0) 207 495 2379
email: info@tizianalifesciences.com

[1] https://www.pnas.org/doi/10.1073/pnas.2220272120

[2] https://www.pnas.org/doi/10.1073/pnas.2309221120

Allowed claims cover Lowe syndrome and Dent disease 2; Can-Fite holds development, commercialization, and out-licensing rights for these indications under its agreement with Fondazione Telethon

Ramat Gan, Israel, Nov. 02, 2026 (GLOBE NEWSWIRE) — Can-Fite BioPharma Ltd. (NYSE American: CANF) (TASE:CANF), a biotechnology company advancing a pipeline of proprietary small molecule drugs that address oncological and inflammatory diseases, today announced that the Eurasian Patent Office (EAPO) has issued a notification of readiness to grant a patent covering the use of Piclidenoson for the treatment of diseases associated with OCRL deficiency, including Lowe syndrome and Dent disease 2.

Lowe syndrome is a rare X-linked multisystem genetic disorder caused by mutations in the OCRL gene, resulting in severe renal, neurological, and ocular manifestations. The renal disease is characterized by progressive proximal tubular dysfunction leading to Fanconi syndrome, chronic kidney disease, and eventual kidney failure. Current management is supportive, and no approved therapy addresses the underlying disease mechanism.

The patent application is owned by Fondazione Telethon, Can-Fite’s research partner. Under its agreement with Fondazione Telethon, Can-Fite holds the rights to develop, commercialize, and out-license Piclidenoson for the treatment of Lowe syndrome. The allowance strengthens the intellectual property foundation supporting Can-Fite’s development program and future partnering opportunities in this indication. The grant remains subject to completion of the required formalities.

Piclidenoson was selected for clinical evaluation based on compelling preclinical studies demonstrating restoration of OCRL-dependent cellular function conducted by Dr. Antonella De Matteis, Professor of Biology, Department of Molecular Medicine and Medical Biotechnology at the University of Naples Federico II, and Program Coordinator of the Cell Biology and Disease Mechanisms at the Telethon Institute of Genetics and Medicine (TIGEM) in Italy. Can-Fite and Fondazione Telethon have signed a collaboration agreement for the clinical development of Piclidenoson for the treatment of Lowe Syndrome, a high medical need with no drug available.  

The Phase 2 study is an open-label, single-center clinical trial designed to evaluate the efficacy and safety of oral Piclidenoson administered twice daily for six months in 5 adult patients with genetically confirmed Lowe syndrome. The primary endpoint is improvement in renal uptake of 99mTc-DMSA as a measure of proximal tubular reabsorption capacity, with secondary endpoints evaluating urinary biomarkers of tubular function, Fanconi syndrome parameters, and safety.

“This patent allowance strengthens the intellectual property foundation of our Lowe syndrome program and supports its long-term commercial potential,” said Motti Farbstein, CEO of Can-Fite BioPharma. “Together with our development, commercialization, and out-licensing rights, this milestone supports our strategy to advance Piclidenoson as a potential treatment for patients with this rare genetic disease and pursue future partnering opportunities.”

About Piclidenoson

Piclidenoson is a robust anti-inflammatory agent, currently being evaluated in a pivotal Phase 3 psoriasis clinical study under approval of both the U.S. Food and Drug Administration (FDA) and the European Medicines Agency (EMA).

Piclidenoson is a novel, first-in-class, A3 adenosine receptor agonist (A3AR) small molecule, orally bioavailable drug with an excellent safety profile demonstrating evidence of efficacy in Phase II and Phase III clinical studies. The drug’s mechanism of action entails inhibition of the inflammatory cytokines interleukin 17 and 23 (IL-17 and IL-23) and the induction of apoptosis of patients’ skin cell keratinocytes involved with the disease pathogenicity.

About Fondazione Telethon

Fondazione Telethon ETS is one of the main Italian biomedical charities, founded in 1990 on the initiative of a group of patients suffering from muscular dystrophy. Its mission is to achieve the cure of rare genetic diseases through scientific research of excellence, selected according to the best practices shared internationally. Through a unique method in the Italian panorama, it follows the entire “research chain” dealing with fundraising, selection and funding of projects and the research activity itself carried out in the centers and laboratories of the Foundation. Telethon also develops collaborations with public health institutions and pharmaceutical industries to translate the results of research into therapies accessible to patients.  Since its foundation, Telethon has invested more than 660 million euros in research, has funded 2,960 projects with 1,720 researchers involved and 630 diseases studied. To date, thanks to Fondazione Telethon, the first gene therapy with stem cells in the world has been made available, thanks to the collaboration with the pharmaceutical industry. This therapy is intended for the treatment of ADA-SCID, a severe immunodeficiency that compromises the body’s defenses from birth. In 2023, Fondazione Telethon became responsible for the production and distribution of the drug to eligible patients in the European Union 

Another gene therapy resulting from Telethon research made available is the one for a serious neurodegenerative disease, metachromatic leukodystrophy. This therapeutic approach is in an advanced stage of development for another immunodeficiency, Wiskott-Aldrich syndrome. Other diseases on which the gene therapy developed by Telethon researchers has been evaluated in patients are beta thalassemia and two metabolic diseases of childhood, mucopolysaccharidosis type 6 and type 1. In addition, within the Telethon institutes a targeted therapeutic strategy is being studied or developed for other genetic diseases, such as hemophilia or various hereditary vision defects. In parallel, the study of basic mechanisms and potential therapeutic approaches for diseases still unanswered continues in all laboratories funded by Telethon. 

About Can-Fite BioPharma Ltd.

Can-Fite BioPharma Ltd. (NYSE American: CANF) (TASE: CANF) is an advanced clinical stage drug development Company with a platform technology that is designed to address multi-billion dollar markets in the treatment of cancer, liver, and inflammatory disease. The Company’s lead drug candidate, Piclidenoson recently reported topline results in a Phase 3 trial for psoriasis and commenced a pivotal Phase 3 trial. Can-Fite’s liver drug, Namodenoson, is being evaluated in a Phase III trial for hepatocellular carcinoma (HCC), a Phase 2b trial for the treatment of MASH, and in a Phase 2a study in pancreatic cancer. Namodenoson has been granted Orphan Drug Designation in the U.S. and Europe and Fast Track Designation as a second line treatment for HCC by the U.S. Food and Drug Administration. Namodenoson has also shown proof of concept to potentially treat other cancers including colon, prostate, and melanoma. CF602, the Company’s third drug candidate, has shown efficacy in the treatment of erectile dysfunction. These drugs have an excellent safety profile with experience in over 1,600 patients in clinical studies to date. For more information please visit: www.canfite.com.

Forward-Looking Statements

This press release may contain forward-looking statements, about Can-Fite’s expectations, beliefs or intentions regarding, among other things, the expected grant of the patent described herein, the scope and potential benefits of intellectual property protection, Can-Fite’s development of Piclidenoson for Lowe syndrome, and potential commercialization and partnering opportunities. All statements in this communication, other than those relating to historical facts, are “forward looking statements”. Forward-looking statements can be identified by the use of forward-looking words such as “believe,” “expect,” “intend,” “plan,” “may,” “should” or “anticipate” or their negatives or other variations of these words or other comparable words or by the fact that these statements do not relate strictly to historical or current matters. Forward-looking statements relate to anticipated or expected events, activities, trends or results as of the date they are made. Because forward-looking statements relate to matters that have not yet occurred, these statements are inherently subject to known and unknown risks, uncertainties and other factors that may cause Can-Fite’s actual results, performance or achievements to be materially different from any future results, performance or achievements expressed or implied by the forward-looking statements. Important factors that could cause actual results, performance or achievements to differ materially from those anticipated in these forward-looking statements include, among other things, our market and other conditions, history of losses and needs for additional capital to fund our operations and our inability to obtain additional capital on acceptable terms, or at all; uncertainties of cash flows and inability to meet working capital needs; the initiation, timing, progress and results of our preclinical studies, clinical trials and other product candidate development efforts; our ability to advance our product candidates into clinical trials or to successfully complete our preclinical studies or clinical trials; our receipt of regulatory approvals for our product candidates, and the timing of other regulatory filings and approvals; the clinical development, commercialization and market acceptance of our product candidates; our ability to establish and maintain strategic partnerships and other corporate collaborations; the implementation of our business model and strategic plans for our business and product candidates; the scope of protection we are able to establish and maintain for intellectual property rights covering our product candidates and our ability to operate our business without infringing the intellectual property rights of others; competitive companies, technologies and our industry; risks related to not satisfying the continued listing requirements of NYSE American; and statements as to the impact of the political and security situation in Israel on our business. More information on these risks, uncertainties and other factors is included from time to time in the “Risk Factors” section of Can-Fite’s Annual Report on Form 20-F filed with the SEC on March 26, 2026 and other public reports filed with the SEC and in its periodic filings with the TASE. Existing and prospective investors are cautioned not to place undue reliance on these forward-looking statements, which speak only as of the date hereof. Can-Fite undertakes no obligation to publicly update or review any forward-looking statement, whether as a result of new information, future developments or otherwise, except as may be required by any applicable securities laws.

Contact

Can-Fite BioPharma

Motti Farbstein 

info@canfite.com

+972-3-9241114

Allowed claims cover Lowe syndrome and Dent disease 2; Can-Fite holds development, commercialization, and out-licensing rights for these indications under its agreement with Fondazione Telethon

Ramat Gan, Israel, Nov. 02, 2026 (GLOBE NEWSWIRE) — Can-Fite BioPharma Ltd. (NYSE American: CANF) (TASE:CANF), a biotechnology company advancing a pipeline of proprietary small molecule drugs that address oncological and inflammatory diseases, today announced that the Eurasian Patent Office (EAPO) has issued a notification of readiness to grant a patent covering the use of Piclidenoson for the treatment of diseases associated with OCRL deficiency, including Lowe syndrome and Dent disease 2.

Lowe syndrome is a rare X-linked multisystem genetic disorder caused by mutations in the OCRL gene, resulting in severe renal, neurological, and ocular manifestations. The renal disease is characterized by progressive proximal tubular dysfunction leading to Fanconi syndrome, chronic kidney disease, and eventual kidney failure. Current management is supportive, and no approved therapy addresses the underlying disease mechanism.

The patent application is owned by Fondazione Telethon, Can-Fite’s research partner. Under its agreement with Fondazione Telethon, Can-Fite holds the rights to develop, commercialize, and out-license Piclidenoson for the treatment of Lowe syndrome. The allowance strengthens the intellectual property foundation supporting Can-Fite’s development program and future partnering opportunities in this indication. The grant remains subject to completion of the required formalities.

Piclidenoson was selected for clinical evaluation based on compelling preclinical studies demonstrating restoration of OCRL-dependent cellular function conducted by Dr. Antonella De Matteis, Professor of Biology, Department of Molecular Medicine and Medical Biotechnology at the University of Naples Federico II, and Program Coordinator of the Cell Biology and Disease Mechanisms at the Telethon Institute of Genetics and Medicine (TIGEM) in Italy. Can-Fite and Fondazione Telethon have signed a collaboration agreement for the clinical development of Piclidenoson for the treatment of Lowe Syndrome, a high medical need with no drug available.  

The Phase 2 study is an open-label, single-center clinical trial designed to evaluate the efficacy and safety of oral Piclidenoson administered twice daily for six months in 5 adult patients with genetically confirmed Lowe syndrome. The primary endpoint is improvement in renal uptake of 99mTc-DMSA as a measure of proximal tubular reabsorption capacity, with secondary endpoints evaluating urinary biomarkers of tubular function, Fanconi syndrome parameters, and safety.

“This patent allowance strengthens the intellectual property foundation of our Lowe syndrome program and supports its long-term commercial potential,” said Motti Farbstein, CEO of Can-Fite BioPharma. “Together with our development, commercialization, and out-licensing rights, this milestone supports our strategy to advance Piclidenoson as a potential treatment for patients with this rare genetic disease and pursue future partnering opportunities.”

About Piclidenoson

Piclidenoson is a robust anti-inflammatory agent, currently being evaluated in a pivotal Phase 3 psoriasis clinical study under approval of both the U.S. Food and Drug Administration (FDA) and the European Medicines Agency (EMA).

Piclidenoson is a novel, first-in-class, A3 adenosine receptor agonist (A3AR) small molecule, orally bioavailable drug with an excellent safety profile demonstrating evidence of efficacy in Phase II and Phase III clinical studies. The drug’s mechanism of action entails inhibition of the inflammatory cytokines interleukin 17 and 23 (IL-17 and IL-23) and the induction of apoptosis of patients’ skin cell keratinocytes involved with the disease pathogenicity.

About Fondazione Telethon

Fondazione Telethon ETS is one of the main Italian biomedical charities, founded in 1990 on the initiative of a group of patients suffering from muscular dystrophy. Its mission is to achieve the cure of rare genetic diseases through scientific research of excellence, selected according to the best practices shared internationally. Through a unique method in the Italian panorama, it follows the entire “research chain” dealing with fundraising, selection and funding of projects and the research activity itself carried out in the centers and laboratories of the Foundation. Telethon also develops collaborations with public health institutions and pharmaceutical industries to translate the results of research into therapies accessible to patients.  Since its foundation, Telethon has invested more than 660 million euros in research, has funded 2,960 projects with 1,720 researchers involved and 630 diseases studied. To date, thanks to Fondazione Telethon, the first gene therapy with stem cells in the world has been made available, thanks to the collaboration with the pharmaceutical industry. This therapy is intended for the treatment of ADA-SCID, a severe immunodeficiency that compromises the body’s defenses from birth. In 2023, Fondazione Telethon became responsible for the production and distribution of the drug to eligible patients in the European Union 

Another gene therapy resulting from Telethon research made available is the one for a serious neurodegenerative disease, metachromatic leukodystrophy. This therapeutic approach is in an advanced stage of development for another immunodeficiency, Wiskott-Aldrich syndrome. Other diseases on which the gene therapy developed by Telethon researchers has been evaluated in patients are beta thalassemia and two metabolic diseases of childhood, mucopolysaccharidosis type 6 and type 1. In addition, within the Telethon institutes a targeted therapeutic strategy is being studied or developed for other genetic diseases, such as hemophilia or various hereditary vision defects. In parallel, the study of basic mechanisms and potential therapeutic approaches for diseases still unanswered continues in all laboratories funded by Telethon. 

About Can-Fite BioPharma Ltd.

Can-Fite BioPharma Ltd. (NYSE American: CANF) (TASE: CANF) is an advanced clinical stage drug development Company with a platform technology that is designed to address multi-billion dollar markets in the treatment of cancer, liver, and inflammatory disease. The Company’s lead drug candidate, Piclidenoson recently reported topline results in a Phase 3 trial for psoriasis and commenced a pivotal Phase 3 trial. Can-Fite’s liver drug, Namodenoson, is being evaluated in a Phase III trial for hepatocellular carcinoma (HCC), a Phase 2b trial for the treatment of MASH, and in a Phase 2a study in pancreatic cancer. Namodenoson has been granted Orphan Drug Designation in the U.S. and Europe and Fast Track Designation as a second line treatment for HCC by the U.S. Food and Drug Administration. Namodenoson has also shown proof of concept to potentially treat other cancers including colon, prostate, and melanoma. CF602, the Company’s third drug candidate, has shown efficacy in the treatment of erectile dysfunction. These drugs have an excellent safety profile with experience in over 1,600 patients in clinical studies to date. For more information please visit: www.canfite.com.

Forward-Looking Statements

This press release may contain forward-looking statements, about Can-Fite’s expectations, beliefs or intentions regarding, among other things, the expected grant of the patent described herein, the scope and potential benefits of intellectual property protection, Can-Fite’s development of Piclidenoson for Lowe syndrome, and potential commercialization and partnering opportunities. All statements in this communication, other than those relating to historical facts, are “forward looking statements”. Forward-looking statements can be identified by the use of forward-looking words such as “believe,” “expect,” “intend,” “plan,” “may,” “should” or “anticipate” or their negatives or other variations of these words or other comparable words or by the fact that these statements do not relate strictly to historical or current matters. Forward-looking statements relate to anticipated or expected events, activities, trends or results as of the date they are made. Because forward-looking statements relate to matters that have not yet occurred, these statements are inherently subject to known and unknown risks, uncertainties and other factors that may cause Can-Fite’s actual results, performance or achievements to be materially different from any future results, performance or achievements expressed or implied by the forward-looking statements. Important factors that could cause actual results, performance or achievements to differ materially from those anticipated in these forward-looking statements include, among other things, our market and other conditions, history of losses and needs for additional capital to fund our operations and our inability to obtain additional capital on acceptable terms, or at all; uncertainties of cash flows and inability to meet working capital needs; the initiation, timing, progress and results of our preclinical studies, clinical trials and other product candidate development efforts; our ability to advance our product candidates into clinical trials or to successfully complete our preclinical studies or clinical trials; our receipt of regulatory approvals for our product candidates, and the timing of other regulatory filings and approvals; the clinical development, commercialization and market acceptance of our product candidates; our ability to establish and maintain strategic partnerships and other corporate collaborations; the implementation of our business model and strategic plans for our business and product candidates; the scope of protection we are able to establish and maintain for intellectual property rights covering our product candidates and our ability to operate our business without infringing the intellectual property rights of others; competitive companies, technologies and our industry; risks related to not satisfying the continued listing requirements of NYSE American; and statements as to the impact of the political and security situation in Israel on our business. More information on these risks, uncertainties and other factors is included from time to time in the “Risk Factors” section of Can-Fite’s Annual Report on Form 20-F filed with the SEC on March 26, 2026 and other public reports filed with the SEC and in its periodic filings with the TASE. Existing and prospective investors are cautioned not to place undue reliance on these forward-looking statements, which speak only as of the date hereof. Can-Fite undertakes no obligation to publicly update or review any forward-looking statement, whether as a result of new information, future developments or otherwise, except as may be required by any applicable securities laws.

Contact

Can-Fite BioPharma

Motti Farbstein 

info@canfite.com

+972-3-9241114

MONCTON, New Brunswick, Nov. 02, 2026 (GLOBE NEWSWIRE) — Major Drilling Group International Inc. (“Major Drilling” or the “Company”) (TSX: MDI) is pleased to announce that, through its Australian subsidiary, Major Drilling Pty Ltd, it has acquired all of the issued and outstanding shares of Bunbury Drilling Company (“BDC”), a leading specialized mine dewatering drilling contractor based in Bunbury, Western Australia, for an upfront cash payment of A$50 million, with an additional A$20 million available through an earn-out, for total consideration of up to A$70 million, or approximately C$69 million (the “Acquisition”).

Transaction Highlights:

  • Expansion of the Company’s service offering as BDC brings over 70 years of operational expertise with a focus on mine site services, including dewatering drilling, supplementing the Company’s existing operations in Australia while also creating a potential platform for future growth in other markets where these services are in demand.
  • Deepens relationships with senior mining companies as BDC currently drills exclusively for senior producers in Western Australia, holding similarly high standards for safety, equipment maintenance, and operational performance.
  • Strongly aligns with the Company’s focus on specialized drilling while adding a new service offering as mine dewatering represents a unique market segment given its technical complexity, equipment requirements, and need for highly skilled crews. BDC’s eight high-end, well-maintained specialized drills are purpose-built for this work.
  • For the twelve-month period ending June 30, 2026, BDC generated revenue of approximately A$43 million1 and adjusted EBITDA of approximately A$15 million2. Given the highly specialized nature of this type of drilling, this segment is expected to offer stronger gross and EBITDA margins relative to conventional or underground drilling.
  • The Acquisition is expected to be immediately accretive on an earnings per share basis and is well supported by Major Drilling’s strong balance sheet, with the upfront purchase price of A$50 million funded by existing cash on hand and debt facilities, while the additional earn-out of up to A$20 million is subject to the achievement of certain EBITDA milestones over a three-year period, for total consideration of up to A$70 million (~C$69 million).

“We are very excited to welcome BDC and its employees into the Major Drilling group,” said Denis Larocque, President & CEO of Major Drilling. “This acquisition is directly aligned with our strategic plan, allowing us to offer a new line of highly specialized drilling services to senior companies in an established market, diversifying our revenue streams and expanding on existing relationships. BDC has a strong reputation in Australia, particularly among major mining companies, which has been built on decades of delivering innovation and high-quality services to its clients. BDC’s management team will remain in place to continue building on these strong relationships, while our existing local team is well positioned to support a smooth integration. BDC and Major Drilling share similar cultural and operational values, with a commitment to safety, strong maintenance practices, and high operational standards.”

“After more than 70 years and three generations as a family business, we are proud to see BDC become part of Major Drilling,” said Jason Linaker, Principal of BDC. “For seven decades, we have built our reputation on trusted relationships, technical expertise, and a workforce who take genuine pride in their work. We are immensely proud of our team as their achievements are what attracted the attention of a global industry leader like Major Drilling, a company that shares our values and commitment to safety, quality, and people. This transaction honours our family legacy while opening an exciting new chapter for BDC as we are confident it will enable future generations of our team to make the company proud for another 70 years. By combining Major Drilling’s resources and global reach with BDC’s hydrogeological expertise and experienced crews, we are well positioned to pursue growth in Australia and around the world.”

As per the terms of the agreement, Major Drilling will pay up to a maximum of A$70 million for BDC, comprised of (i) a cash payment of A$50 million paid on closing of the Acquisition, subject to working capital adjustments; and (ii) an earn-out of up to A$20 million payable in cash over the next three years, based on the achievement of certain EBITDA milestones. In order to achieve the full earn-out amount, BDC is required to reach average annual EBITDA of approximately A$18 million over the three-year earn-out period. As previously discussed, the purchase price will be funded by Major Drilling’s existing cash position and debt facilities. The Acquisition does not require regulatory approvals.

Forward-Looking Statements

This news release includes certain information that may constitute “forward-looking information” under applicable Canadian securities legislation. All statements, other than statements of historical facts, included in this news release that address future events, developments, or performance that the Company expects to occur (including management’s expectations regarding the Company’s objectives, strategies, financial condition, results of operations, cash flows and businesses) are forward-looking statements. Forward-looking statements are typically identified by future or conditional verbs such as “outlook”, “believe”, “anticipate”, “estimate”, “project”, “expect”, “intend”, “plan”, and terms and expressions of similar import. All forward-looking information in this news release is qualified by this cautionary note.

Forward-looking information is necessarily based upon various estimates and assumptions including, without limitation, the expectations and beliefs of management related to the factors set forth below. While these factors and assumptions are considered reasonable by the Company as at the date of this document in light of management’s experience and perception of current conditions and expected developments, these statements are inherently subject to significant business, economic and competitive uncertainties and contingencies. Known and unknown factors could cause actual results to differ materially from those projected in the forward-looking statements and undue reliance should not be placed on such statements and information.

Such forward-looking statements are subject to a number of risks and uncertainties that include, but are not limited to: the level of activity in the mining industry and the demand for the Company’s services; global and local political and economic environments and conditions; competitive pressures; exposure to currency movements (which can affect the Company’s revenue in Canadian dollars); currency restrictions; measures affecting trade relations between countries, including the imposition of tariffs and countermeasures, as well as the possible impacts on the Company’s clients, operations and, more generally, the economy; skilled labour availability/retention for drill crews; the level of funding for the Company’s clients (particularly for junior mining companies); the integration of business acquisitions and the realization of the intended benefits of such acquisitions; changes in jurisdictions in which the Company operates (including changes in regulation); efficient management of the Company’s growth; the Company’s dependence on key customers; the impact of operational changes; safety of the Company’s workforce; risks and uncertainties relating to climate change and natural disasters; the geographic distribution of the Company’s operations; failure by counterparties to fulfill contractual obligations; disease outbreak; as well as other risk factors described under “General Risks and Uncertainties” in the Company’s MD&A for the year ended April 30, 2026, available on the SEDAR+ website at www.sedarplus.ca. Should one or more risk, uncertainty, contingency, or other factor materialize or should any factor or assumption prove incorrect, actual results could vary materially from those expressed or implied in the forward-looking information.

Forward-looking statements made in this document are made as of the date of this document and the Company disclaims any intention and assumes no obligation to update any forward-looking statement, even if new information becomes available, as a result of future events, or for any other reasons, except as required by applicable securities laws.

About Major Drilling

Major Drilling Group International Inc. is the world’s largest provider of drilling services in the metals and mining industry. The diverse needs of the Company’s global clientele are met through field operations and registered offices that span across North America, South America, Australia, Asia, Africa, and Europe. Established in 1980, the Company has grown to become a global brand in the mining space, known for tackling many of the world’s most challenging drilling projects. Supported by a highly skilled workforce, Major Drilling is led by an experienced senior management team that has steered it through various economic and mining cycles, supported by regional managers known for delivering decades of superior project management.

Major Drilling is regarded as an industry expert at delivering a wide range of drilling services, including reverse circulation, surface and underground coring, directional, sonic, geotechnical, environmental, water-well, coal-bed methane, shallow gas, underground percussive/longhole, and surface drill and blast, along with the ongoing development and evolution of its suite of data and technology-driven innovation services.

For further information:
Ryan Hanley
Director of Capital Markets
Tel: (506) 227-2426
ir@majordrilling.com

1 Revenue is derived from BDC’s unaudited financial statements for the fiscal year ended June 30, 2026, which were not prepared in accordance with IFRS; revenue under IFRS would not change materially.
2 EBITDA and Adjusted EBITDA are non-IFRS financial measures without standardized meanings under IFRS and may not be comparable to similar measures presented by other issuers. This information is derived from BDC’s unaudited financial information, which was not prepared in accordance with IFRS and would not change materially under IFRS.

MONCTON, New Brunswick, Nov. 02, 2026 (GLOBE NEWSWIRE) — Major Drilling Group International Inc. (“Major Drilling” or the “Company”) (TSX: MDI) is pleased to announce that, through its Australian subsidiary, Major Drilling Pty Ltd, it has acquired all of the issued and outstanding shares of Bunbury Drilling Company (“BDC”), a leading specialized mine dewatering drilling contractor based in Bunbury, Western Australia, for an upfront cash payment of A$50 million, with an additional A$20 million available through an earn-out, for total consideration of up to A$70 million, or approximately C$69 million (the “Acquisition”).

Transaction Highlights:

  • Expansion of the Company’s service offering as BDC brings over 70 years of operational expertise with a focus on mine site services, including dewatering drilling, supplementing the Company’s existing operations in Australia while also creating a potential platform for future growth in other markets where these services are in demand.
  • Deepens relationships with senior mining companies as BDC currently drills exclusively for senior producers in Western Australia, holding similarly high standards for safety, equipment maintenance, and operational performance.
  • Strongly aligns with the Company’s focus on specialized drilling while adding a new service offering as mine dewatering represents a unique market segment given its technical complexity, equipment requirements, and need for highly skilled crews. BDC’s eight high-end, well-maintained specialized drills are purpose-built for this work.
  • For the twelve-month period ending June 30, 2026, BDC generated revenue of approximately A$43 million1 and adjusted EBITDA of approximately A$15 million2. Given the highly specialized nature of this type of drilling, this segment is expected to offer stronger gross and EBITDA margins relative to conventional or underground drilling.
  • The Acquisition is expected to be immediately accretive on an earnings per share basis and is well supported by Major Drilling’s strong balance sheet, with the upfront purchase price of A$50 million funded by existing cash on hand and debt facilities, while the additional earn-out of up to A$20 million is subject to the achievement of certain EBITDA milestones over a three-year period, for total consideration of up to A$70 million (~C$69 million).

“We are very excited to welcome BDC and its employees into the Major Drilling group,” said Denis Larocque, President & CEO of Major Drilling. “This acquisition is directly aligned with our strategic plan, allowing us to offer a new line of highly specialized drilling services to senior companies in an established market, diversifying our revenue streams and expanding on existing relationships. BDC has a strong reputation in Australia, particularly among major mining companies, which has been built on decades of delivering innovation and high-quality services to its clients. BDC’s management team will remain in place to continue building on these strong relationships, while our existing local team is well positioned to support a smooth integration. BDC and Major Drilling share similar cultural and operational values, with a commitment to safety, strong maintenance practices, and high operational standards.”

“After more than 70 years and three generations as a family business, we are proud to see BDC become part of Major Drilling,” said Jason Linaker, Principal of BDC. “For seven decades, we have built our reputation on trusted relationships, technical expertise, and a workforce who take genuine pride in their work. We are immensely proud of our team as their achievements are what attracted the attention of a global industry leader like Major Drilling, a company that shares our values and commitment to safety, quality, and people. This transaction honours our family legacy while opening an exciting new chapter for BDC as we are confident it will enable future generations of our team to make the company proud for another 70 years. By combining Major Drilling’s resources and global reach with BDC’s hydrogeological expertise and experienced crews, we are well positioned to pursue growth in Australia and around the world.”

As per the terms of the agreement, Major Drilling will pay up to a maximum of A$70 million for BDC, comprised of (i) a cash payment of A$50 million paid on closing of the Acquisition, subject to working capital adjustments; and (ii) an earn-out of up to A$20 million payable in cash over the next three years, based on the achievement of certain EBITDA milestones. In order to achieve the full earn-out amount, BDC is required to reach average annual EBITDA of approximately A$18 million over the three-year earn-out period. As previously discussed, the purchase price will be funded by Major Drilling’s existing cash position and debt facilities. The Acquisition does not require regulatory approvals.

Forward-Looking Statements

This news release includes certain information that may constitute “forward-looking information” under applicable Canadian securities legislation. All statements, other than statements of historical facts, included in this news release that address future events, developments, or performance that the Company expects to occur (including management’s expectations regarding the Company’s objectives, strategies, financial condition, results of operations, cash flows and businesses) are forward-looking statements. Forward-looking statements are typically identified by future or conditional verbs such as “outlook”, “believe”, “anticipate”, “estimate”, “project”, “expect”, “intend”, “plan”, and terms and expressions of similar import. All forward-looking information in this news release is qualified by this cautionary note.

Forward-looking information is necessarily based upon various estimates and assumptions including, without limitation, the expectations and beliefs of management related to the factors set forth below. While these factors and assumptions are considered reasonable by the Company as at the date of this document in light of management’s experience and perception of current conditions and expected developments, these statements are inherently subject to significant business, economic and competitive uncertainties and contingencies. Known and unknown factors could cause actual results to differ materially from those projected in the forward-looking statements and undue reliance should not be placed on such statements and information.

Such forward-looking statements are subject to a number of risks and uncertainties that include, but are not limited to: the level of activity in the mining industry and the demand for the Company’s services; global and local political and economic environments and conditions; competitive pressures; exposure to currency movements (which can affect the Company’s revenue in Canadian dollars); currency restrictions; measures affecting trade relations between countries, including the imposition of tariffs and countermeasures, as well as the possible impacts on the Company’s clients, operations and, more generally, the economy; skilled labour availability/retention for drill crews; the level of funding for the Company’s clients (particularly for junior mining companies); the integration of business acquisitions and the realization of the intended benefits of such acquisitions; changes in jurisdictions in which the Company operates (including changes in regulation); efficient management of the Company’s growth; the Company’s dependence on key customers; the impact of operational changes; safety of the Company’s workforce; risks and uncertainties relating to climate change and natural disasters; the geographic distribution of the Company’s operations; failure by counterparties to fulfill contractual obligations; disease outbreak; as well as other risk factors described under “General Risks and Uncertainties” in the Company’s MD&A for the year ended April 30, 2026, available on the SEDAR+ website at www.sedarplus.ca. Should one or more risk, uncertainty, contingency, or other factor materialize or should any factor or assumption prove incorrect, actual results could vary materially from those expressed or implied in the forward-looking information.

Forward-looking statements made in this document are made as of the date of this document and the Company disclaims any intention and assumes no obligation to update any forward-looking statement, even if new information becomes available, as a result of future events, or for any other reasons, except as required by applicable securities laws.

About Major Drilling

Major Drilling Group International Inc. is the world’s largest provider of drilling services in the metals and mining industry. The diverse needs of the Company’s global clientele are met through field operations and registered offices that span across North America, South America, Australia, Asia, Africa, and Europe. Established in 1980, the Company has grown to become a global brand in the mining space, known for tackling many of the world’s most challenging drilling projects. Supported by a highly skilled workforce, Major Drilling is led by an experienced senior management team that has steered it through various economic and mining cycles, supported by regional managers known for delivering decades of superior project management.

Major Drilling is regarded as an industry expert at delivering a wide range of drilling services, including reverse circulation, surface and underground coring, directional, sonic, geotechnical, environmental, water-well, coal-bed methane, shallow gas, underground percussive/longhole, and surface drill and blast, along with the ongoing development and evolution of its suite of data and technology-driven innovation services.

For further information:
Ryan Hanley
Director of Capital Markets
Tel: (506) 227-2426
ir@majordrilling.com

1 Revenue is derived from BDC’s unaudited financial statements for the fiscal year ended June 30, 2026, which were not prepared in accordance with IFRS; revenue under IFRS would not change materially.
2 EBITDA and Adjusted EBITDA are non-IFRS financial measures without standardized meanings under IFRS and may not be comparable to similar measures presented by other issuers. This information is derived from BDC’s unaudited financial information, which was not prepared in accordance with IFRS and would not change materially under IFRS.

BEDFORD, Mass., Nov. 02, 2026 (GLOBE NEWSWIRE) — Ocular Therapeutix, Inc. (NASDAQ: OCUL, “Ocular”), an integrated biopharmaceutical company committed to redefining the retina experience, today announced that it plans to host a conference call and webcast on Monday, November 9, 2026 at 8:00 AM ET to discuss recent business progress and financial results for the third quarter ended September 30, 2026.

Conference Call and Webcast Information:

Date: Monday, November 9, 2026 at 8:00 AM ET

Participant Dial-In (U.S.): 1-833-419-0865

Participant Dial-In (International): 1-785-838-9333

Conference ID: OCULAR (required for entry)

Webcast Access: Please click here

The live and archived webcast can also be accessed by visiting the Ocular Therapeutix website on the Events and Presentations section of the Investor Relations page. A replay of the webcast will be archived for at least 30 days following the presentation.

About Ocular Therapeutix, Inc.
Ocular Therapeutix, Inc. is an integrated biopharmaceutical company committed to redefining the retina experience. AXPAXLI™ (also known as OTX-TKI), Ocular’s investigational product candidate for retinal disease, is an axitinib intravitreal hydrogel based on its ELUTYX™ proprietary bioresorbable hydrogel-based formulation technology. AXPAXLI is currently in Phase 3 clinical trials for wet age-related macular degeneration (wet AMD) and diabetic retinal disease, including non-proliferative diabetic retinopathy (NPDR).

Ocular’s pipeline also leverages the ELUTYX technology in its commercial product DEXTENZA®, an FDA-approved corticosteroid for the treatment of ocular inflammation and pain following ophthalmic surgery in adults and pediatric patients and ocular itching associated with allergic conjunctivitis in adults and pediatric patients aged two years or older, and in its investigational product candidate OTX-TIC, which is a travoprost intracameral hydrogel that has completed a Phase 2 clinical trial for the treatment of open-angle glaucoma or ocular hypertension. Ocular is currently evaluating next steps for the OTX-TIC program.

Follow the Company on its website, LinkedIn, or X.

DEXTENZA® is a registered trademark of Ocular Therapeutix, Inc. The Ocular Therapeutix logo, AXPAXLI™, ELUTYX™, and Ocular Therapeutix™ are trademarks of Ocular Therapeutix, Inc.

Investors & Media
Ocular Therapeutix, Inc.
Bill Slattery
Vice President, Investor Relations
bslattery@ocutx.com

BEDFORD, Mass., Nov. 02, 2026 (GLOBE NEWSWIRE) — Ocular Therapeutix, Inc. (NASDAQ: OCUL, “Ocular”), an integrated biopharmaceutical company committed to redefining the retina experience, today announced that it plans to host a conference call and webcast on Monday, November 9, 2026 at 8:00 AM ET to discuss recent business progress and financial results for the third quarter ended September 30, 2026.

Conference Call and Webcast Information:

Date: Monday, November 9, 2026 at 8:00 AM ET

Participant Dial-In (U.S.): 1-833-419-0865

Participant Dial-In (International): 1-785-838-9333

Conference ID: OCULAR (required for entry)

Webcast Access: Please click here

The live and archived webcast can also be accessed by visiting the Ocular Therapeutix website on the Events and Presentations section of the Investor Relations page. A replay of the webcast will be archived for at least 30 days following the presentation.

About Ocular Therapeutix, Inc.
Ocular Therapeutix, Inc. is an integrated biopharmaceutical company committed to redefining the retina experience. AXPAXLI™ (also known as OTX-TKI), Ocular’s investigational product candidate for retinal disease, is an axitinib intravitreal hydrogel based on its ELUTYX™ proprietary bioresorbable hydrogel-based formulation technology. AXPAXLI is currently in Phase 3 clinical trials for wet age-related macular degeneration (wet AMD) and diabetic retinal disease, including non-proliferative diabetic retinopathy (NPDR).

Ocular’s pipeline also leverages the ELUTYX technology in its commercial product DEXTENZA®, an FDA-approved corticosteroid for the treatment of ocular inflammation and pain following ophthalmic surgery in adults and pediatric patients and ocular itching associated with allergic conjunctivitis in adults and pediatric patients aged two years or older, and in its investigational product candidate OTX-TIC, which is a travoprost intracameral hydrogel that has completed a Phase 2 clinical trial for the treatment of open-angle glaucoma or ocular hypertension. Ocular is currently evaluating next steps for the OTX-TIC program.

Follow the Company on its website, LinkedIn, or X.

DEXTENZA® is a registered trademark of Ocular Therapeutix, Inc. The Ocular Therapeutix logo, AXPAXLI™, ELUTYX™, and Ocular Therapeutix™ are trademarks of Ocular Therapeutix, Inc.

Investors & Media
Ocular Therapeutix, Inc.
Bill Slattery
Vice President, Investor Relations
bslattery@ocutx.com

TORONTO, Nov. 02, 2026 (GLOBE NEWSWIRE) — Sunday Lake Gold Corp. (TSX: SNDY, OTCQX: WLBMD) (“Sunday Lake Gold” or the “Company”) is pleased to announce that Mr. Michael Westendorf has been appointed to Sunday Lake Gold’s Board of Directors, effective immediately. Mr. Westendorf was nominated by Waratah Capital Advisors Ltd. (“Waratah”) to serve as its representative on the Board pursuant to the investor rights agreement between the Company and Waratah, as announced on May 20, 2026. Mr. Westendorf will also serve as a member of the Board of Directors’ Technical & Health, Safety and Environment (“HSE“) Committee.

Michael Westendorf is a professional engineer with over 20 years of experience in mining operations, metallurgy, process engineering, capital projects and corporate development. His career spans the full mining lifecycle, from feasibility studies and project development through construction, commissioning, operations and expansion.

Mr. Westendorf currently serves as Chief Operating Officer of Lithium Ionic Corp. where he has played a key role in advancing the company’s Bandeira Lithium Project in Minas Gerais, Brazil. He also serves as Metallurgical Advisor to Kodiak Copper Corp.

Previously, Mr. Westendorf held several senior technical and operational positions at Copper Mountain Mining Corporation, including Director of Operational Excellence, Director of Metallurgy and Mill Manager. During his tenure, he oversaw a 40,000-tonne-per-day copper processing operation, supported mine expansions and operational improvements, and led development activities at the Eva Copper Project in Queensland, Australia.

Mr. Westendorf holds a Bachelor of Applied Science in Metals and Materials Engineering from the University of British Columbia and is a registered Professional Engineer.

Janet Wilkinson, Chairperson of Sunday Lake Gold, commented: “Michael brings extensive technical expertise and a proven track record in mine development, operations and project execution. His experience across all stages of the mining lifecycle, from engineering and feasibility studies through construction and production, will be particularly valuable as we advance the Fenelon Gold Project toward the completion of a pre-feasibility study. We look forward to benefiting from his insights and strategic guidance as we continue to unlock the value of our gold assets and build long-term value for our stakeholders.”

About Sunday Lake Gold Corp.

Sunday Lake Gold Corp. is focused on creating value through the exploration and sustainable development of gold projects in Quebec’s Abitibi region while respecting the environment and communities where it operates. The Company holds a contiguous mineral property position totaling 598 km2 that extends approximately 82 km along the Detour-Fenelon gold trend. The property is host to the Company’s flagship PEA-stage Fenelon Gold Project, and its earlier exploration stage Martiniere Gold Project, as well as numerous greenfield gold projects.

For further information please visit the Company’s website at www.sundaylakegold.com or contact:

Brian Penny, CPA, CMA   Tania Barreto, CPIR
CEO    Director Investor Relations
Email: bpenny@sundaylakegold.com   Email: tbarreto@sundaylakegold.com
M: +1 416 716 8346   M: +1 289 819 3012


Cautionary Note Regarding Forward-Looking Information

The information in this document may contain forward-looking statements or information (collectively, “FLI”) within the meaning of applicable Canadian securities legislation. FLI is based on expectations, estimates, projections and interpretations as at the date of this document.

All statements, other than statements of historical fact, included herein are FLI that involve various risks, assumptions, estimates and uncertainties. Generally, FLI can be identified by the use of statements that include, but are not limited to, words such as “seeks”, “believes”, “anticipates”, “plans”, “continues”, “budget”, “scheduled”, “estimates”, “expects”, “forecasts”, “intends”, “projects”, “predicts”, “proposes”, “potential”, “targets” and variations of such words and phrases, or by statements that certain actions, events or results “may”, “will”, “could”, “would”, “should” or “might”, “be taken”, “occur” or “be achieved.”

FLI in this document may include, but is not limited to: the advancement and completion of a pre-feasibility study for Fenelon.

FLI is designed to help you understand management’s current views of its near- and longer-term prospects, and it may not be appropriate for other purposes. FLI by their nature are based on assumptions and involve known and unknown risks, uncertainties and other factors which may cause the actual results, performance, or achievements of the Company to be materially different from any future results, performance or achievements expressed or implied by such FLI. Although the FLI contained in this document is based upon what management believes, or believed at the time, to be reasonable assumptions, the Company cannot assure shareholders and prospective purchasers of securities of the Company that actual results will be consistent with such FLI, as there may be other factors that cause results not to be as anticipated, estimated or intended, and neither the Company nor any other person assumes responsibility for the accuracy and completeness of any such FLI. Except as required by law, the Company does not undertake, and assumes no obligation, to update or revise any such FLI contained in this document to reflect new events or circumstances. Unless otherwise noted, this document has been prepared based on information available as of the date of this document. Accordingly, you should not place undue reliance on the FLI, or information contained herein.

Furthermore, should one or more of the risks, uncertainties or other factors materialize, or should underlying assumptions prove incorrect, actual results may vary materially from those described in FLI.

Assumptions upon which FLI is based, without limitation, include: the results of exploration activities, the Company’s financial position and general economic conditions; the ability of exploration activities to accurately predict mineralization; the accuracy of geological modelling; the ability of the Company to complete further exploration activities; the legitimacy of title and property interests in the Company’s mineral projects; the accuracy of key assumptions, parameters or methods used to estimate MREs and PEAs; the ability of the Company to obtain required approvals; geological, mining and exploration technical problems; failure of equipment or processes to operate as anticipated; the evolution of the global economic climate; metal prices; foreign exchange rates; environmental expectations; community and non-governmental actions; and, the Company’s ability to secure required funding. Risks and uncertainties about Sunday Lake Gold’s business are discussed in the disclosure materials filed with the securities regulatory authorities in Canada, which are available at www.sedarplus.ca.

Cautionary Notes to United States Investors

Sunday Lake Gold Corp. prepares its disclosure in accordance with NI 43-101 which differs from the requirements of the U.S. Securities and Exchange Commission (the “SEC”). Terms relating to mineral properties, mineralization and estimates of mineral reserves and mineral resources and economic studies used herein are defined in accordance with NI 43-101 under the guidelines set out in CIM Definition Standards on Mineral Resources and Mineral Reserves, adopted by the Canadian Institute of Mining, Metallurgy and Petroleum Council on May 19, 2014, as amended. NI 43-101 differs significantly from the disclosure requirements of the SEC generally applicable to US companies. As such, the information presented herein concerning mineral properties, mineralization and estimates of mineral reserves and mineral resources may not be comparable to similar information made public by U.S. companies subject to the reporting and disclosure requirements under the U.S. federal securities laws and the rules and regulations thereunder.

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.