Company to Host Conference Call to Discuss Results at 8:00 a.m. Eastern Time on November 10, 2026

NASHVILLE, Tenn., Oct. 26, 2026 (GLOBE NEWSWIRE) — Harrow (Nasdaq: HROW), a leading provider of ophthalmic disease management solutions in North America, today announced that it will report its financial results for the third quarter ended September 30, 2026, on Monday, November 9, 2026, after the market close. The Company will also post its third quarter Letter to Stockholders to the “Investors” section of its website, harrow.com. Harrow will host a conference call and live webcast at 8:00 a.m. Eastern Time on Tuesday, November 10, 2026, to discuss the results and provide a business update.

Conference Call Information
Participants can access the live webcast of Harrow’s presentation on the “Investors” page of Harrow’s website. A replay of the webcast will be available on the Company’s website for one year.

To participate via telephone, please register in advance using this link. Upon registration, all telephone participants will receive a confirmation email with detailed instructions, including a unique dial-in number and PIN, for accessing the call.

About Harrow
Harrow, Inc. (Nasdaq: HROW) is a leading provider of ophthalmic disease management solutions in North America, offering a comprehensive portfolio of products that address conditions affecting both the front and back of the eye, such as dry eye disease, wet (or neovascular) age-related macular degeneration, cataracts, refractive errors, glaucoma and a range of other ocular surface conditions and retina diseases. Harrow was founded with a commitment to deliver safe, effective, accessible, and affordable medications that enhance patient compliance and improve clinical outcomes. For more information about Harrow, please visit harrow.com and connect with us on LinkedIn.

Contact:
Mike Biega
VP of Investor Relations & Communications
mbiega@harrowinc.com
617-913-8890

VANCOUVER, British Columbia, Oct. 26, 2026 (GLOBE NEWSWIRE) — Goldera Exploration Ltd. (“Goldera” or the “Company”) (TSX Venture Exchange: GERA) is pleased to provide an update on results of its Q2-2026 soil sampling program at Riley Brook in northern New Brunswick, part of the Acadian Gold Joint Venture in which Goldera holds a 65% interest and is the operator. The program has outlined a large 4 km by 2 km gold-tungsten-antimony (arsenic) soil anomaly in the southern part of Riley Brook (refer to Figure 1), together with a second, smaller multi-element anomaly measuring approximately 300 metres by 300 metres in the north. Both anomalies remain open to the limits of the areas surveyed, and soil sampling has covered only approximately 30% of the 334.5 km2 property.

The results are considered important as they coincide with EM and radiometric anomalies from Goldera’s prior airborne HeliTem survey suggestive of conductive units within a felsic unit, and have a metal signature characteristic of felsic intrusion-related mineral systems1.

The Riley Brook Project lies in proximity to the Central Plutonic Belt of New Brunswick, a highly prospective region for Cu-Mo and Au-W intrusive systems2,3. That region, including Acadian Gold’s McIntyre Brook property, has seen a marked increase in exploration attention, most recently focusing on intrusive related metal systems (Avenir Minerals, Agnico Eagle’s subsidiary, and Osisko Critical Minerals Corp.).

Key Highlights:

  • Goldera has identified two large multi-element soil anomalies at Riley Brook. The metal signature is characteristic of a potential precious metal bearing intrusive system in the bedrock, and is supported by mapped felsic intrusive rocks in those areas, together with coincident EM conductors and magnetic zones in Goldera’s airborne survey.
  • Significant untested area: Both soil anomalies are open to the extents of the survey area and soil sampling has covered approximately 30% of Riley Brook, leaving substantial portions of the property to be evaluated.
  • Next-stage target refinement: The results provide a basis for prioritizing areas for additional geological investigation and follow-up surface exploration.
  • Goldera was an early exploration entrant in the region, which has seen significant recent activity by Kinross Gold, Kenorland Minerals, Osisko Metals and Agnico Eagle, who are also evaluating the precious metal and intrusive related potential of the area.

Charles Tarnocai, CEO & Director of Goldera states, “The identification of a large, multi-element soil anomaly that coincides with geophysical and geological features consistent of an intrusion related gold and critical mineral system gives us a more focused basis for evaluating the property’s potential. With soil sampling covering approximately 30% of the property to date, we see a substantial area remaining to be assessed as we continue to prioritize targets for follow-up exploration.”

Figure 1: Soil Geochemical Anomaly Superimposed on Magnetic First Vertical Derivative (1VD) at the Riley Brook Property
Figure 1: Soil Geochemical Anomaly Superimposed on Magnetic First Vertical Derivative (1VD) at the Riley Brook Property

Figure 2: Goldera 2026 Soil Surveys on Riley Brook Property
Figure 2: Goldera 2026 Soil Surveys on Riley Brook Property

Soil Sampling Extends Anomalies from 2024 Surveys

The Riley Brook property is covered by extensive, but generally thin, overburden cover, limiting the geologic exposures. Goldera’s 2026 soil survey collected 1,273 samples. The combined 2024 and 2026 surveys have outlined a significant Au with W and Sb (+ As) anomaly (4 km by 2 km, and open to the margins of the survey) in the southern part of the property. The anomaly is coincident with EM conductors, potentially representing sulphide-bearing zones in the bedrock, and a radiometric anomaly, likely representing an area of felsic rocks, supported by map interpretations of the New Brunswick government. Together, the shape of the anomaly, and its metal and geophysical associations, suggest the potential for a gold and critical mineral associated felsic intrusive system in the southern part of the property, which likewise occurs elsewhere in the region.

An additional 300 m by 300 m Au and Sb (with As, Bi and Te) occurs in the Haystack Mountain area, to the north. Like the southern anomaly, it is open to the extents of the survey. Hematite, pyrite and clay altered intrusive rocks were identified in the area from Goldera’s prospecting.

Soil sampling has covered only 30% of the Riley Brook Project, which has not been previously prospected for epithermal precious metal or intrusive related metal systems, leaving substantial discovery potential on the district-scale property.

Soil sample results were corrected for sample pH following the method of IOS Geoscience4. Anomaly values are presented here at the 98th percentile level for each element, of which a probability level of 80% is typically considered significant. Soil acidity and its cation retention capacity variations can significantly affect the concentration of elements in the soil, and the objective of the method is to normalize for those effects. Soil acidity was directly measured. Cation exchange capacity is not directly measured but is inferred from the charge molality of the major cations in each sample. As with other soil sample treatment considerations, and different from how rock sample results are reviewed, the form and statistical significance of soil sampling results for individual elements is generally considered more important than their absolute value5. Figure 2 shows the soil sample locations from Goldera’s 2024 to present soil surveys which comprise a substantial data set of 2,444 samples. Statistical processing reduced the database to 2,300 samples through outlier removal. The data were processed with the assistance of AI, but were verified through manual calculations.

Acadian Gold

Acadian Gold Corp. (‘Acadian Gold’) is a joint venture with Lode Gold Resources Inc., where Goldera holds 65% interest and operator role (refer to Goldera Exploration Ltd. press release dated August 13, 2026). Acadian Gold is advancing exploration on a large, well-located and under-explored 445 km² land package in northern New Brunswick, located in a highly prospective region for gold and polymetallic mineral discovery. Acadian Gold includes the Riley Brook Project, a 334.5 km2 land package of mineral claims to the south, and McIntyre Brook Project, a 111 km2 property to the north, both properties combined to create a dominant land holding on an orogenic belt where other major developers are established and host certain world-class deposits. Acadian Gold holds a large, strategic, highly prospective land package in an emerging gold-copper camp, host to some of the most prospective geology in the region. McIntyre Brook is well-situated, encompassed by the Williams Brook property held by Puma Exploration Inc. (under option agreement with Kinross Gold Corporation), and Riley Brook is surrounded to the southeast by Kenorland Minerals Ltd.

The exploration thesis is supported by multiple geological and geophysical vectors, including known gold-bearing felsic horizons at McIntyre Brook, coincident gold-in-soil and electromagnetic anomalies, and large-scale multi-element anomalies at Riley Brook. Previous exploration has demonstrated that mineralized trends identified on neighboring properties can extend onto the Acadian Gold land package. At McIntyre Brook, Goldera is following up on a well-defined gold-bearing felsic horizon that has emerged as one of the principal exploration targets within the Acadian Gold Joint Venture. Previous trenching and channel sampling confirmed a gold-bearing rhyolitic horizon with a thicknesses of up to 9 metres, with trench sample results of 5.3 metres at 1.19 g/t Au (refer to Fancamp Exploration Ltd. press release dated January 20, 2025). The broader mineralized felsic trend has now been identified over 3 km, providing substantial scope for continued expansion and additional discovery. An additional 12 km of prospective strike along three structures occur on the property, and remain largely untested. At Acadian Gold, exploration is focused on testing and expanding gold trends at McIntyre Brook, which transgress the property and are on-strike of gold occurrences at the enveloping Williams Brook property of Puma Exploration Inc. (refer to Goldera press release dated August 31, 2026). At Riley Brook, extensive previously identified soil and stream sediment geochemical anomalies with coincident geophysical anomalies suggestive of an un-exposed precious metal bearing intrusive related system.

The combination of high-grade surface mineralization, favorable geological settings, large land positions and significant areas of untested ground provides Goldera with multiple opportunities to expand the known mineralized footprint and generate new discoveries.

Qualified Person

The technical information contained in this press release was reviewed and approved by François Auclair, PGeo, M.Sc. Vice President Exploration of Goldera, designated as a Qualified Person under National Instrument 43-101. M Auclair, the Company’s qualified person and an officer, has reviewed and approved the technical disclosure contained in this news release.

Quality Assurance and Quality Control

François Auclair, PGeo, M.Sc., a Qualified Person as defined by National Instrument 43-101, is responsible for the on-going drilling and sampling program, including quality assurance (QA) and quality control (QC). Assays for the soil sampling and trenching were respectively analyzed by ALS Canada Ltd. and Techni-Lab, a subdivision of Actlabs. The Corporation inserts quality control samples (blanks, standard reference material, and duplicates) at regular intervals to monitor laboratory performance.

References

  1. Hart, C., 2007. Reduced Intrusion-related Gold Systems. in Mineral Deposits of Canada: a synthesis of major deposit-types, district metallogeny, the evolution of geological provinces, and exploration methods.  Edition: Special Publication 5.  Geological Association of Canada, Mineral Deposits Division, Wayne D. Goodfellow, editor. pages 95 to 112.
  2. Karbalaeiramezanali, A., Parsa, M., Lentz, D.R. et al. 2025.  Prospectivity Modeling of Devonian Intrusion-Related W–Mo–Sb–Au Deposits in the Pokiok Plutonic Suite, West-Central New Brunswick, Canada, Using a Monte Carlo-Based Framework. Natural Resources Research, vol. 34, pages 669 to 702. https://doi.org/10.1007/s11053-024-10437-y
  3. Yousefi, F., Lentz, D.R., Walker, J.A., Thorne, K.  2021.  Analysis of porphyry Cu potential, New Brunswick: A preliminary review.  In Exploration, Mining and Petroleum New Brunswick. Kieth, E.A., Editor. New Brunswick Department of Natural Resources and Energy Development, Geoscience Report 2021-1, Page 26
  4. Girard,R., 2022. Polynormalization: A determanistic-stochastic approach to geochemical survey denoising.  Geoscience Canada, vol. 49, pg 115. https://doi.org/10.12789/geocanj.2022.49.188
  5. Govertt, G.J.S., 1976.  Detection of deeply buried and blind sulphide deposits by measurement of H+ and conductivity of closely spaced surface soil samples.  Journal of Geochemical Exploration, Vol. 6, pages 359 to 382.

About Goldera Exploration Ltd.

Goldera Exploration Ltd. (TSX-V:GERA) is a discovery-driven Canadian gold and copper exploration company advancing a portfolio of high-potential exploration assets across Canada’s premier mining districts. Goldera is focused on unlocking value through systematic exploration of district-scale gold and copper projects in Ontario, Québec and New Brunswick, with interests in the Yukon, supported by an experienced technical and capital markets team. Goldera is advancing exploration at its flagship Egan Gold mineral project in Ontario’s Abitibi Greenstone Belt and the Acadian Gold Corp. joint venture in New Brunswick’s emerging gold-copper district.

Further information on Goldera can be found at: www.golderaexploration.com

Website | LinkedIn | X/Twitter

For Further Information

Charles Tarnocai, CEO & Director, Goldera Exploration Ltd.
info@golderaexploration.com

Tara Asfour, Communications & Marketing
tasfour@golderaexploration.com

Cautionary Note Regarding Forward-Looking Information

This news release contains “forward-looking statements” and “forward-looking information” (collectively, “forward-looking statements“) within the meaning of Canadian and United States securities legislation. All statements, other than statements of historical fact, are forward-looking statements. Forward-looking statements in this news release relate to, among other things: the Company’s strategic plans; the composition and timing of completion of the Company’s exploration and drill programs on the Egan Gold Project and the McIntyre Brook and Riley Brook mineral properties held by Acadian Gold; the anticipated objectives, benefits and results of the Company’s exploration programs, including the aim of such programs to test multiple high-priority targets and expand areas of known gold mineralization, with the intention of follow-up drilling in late Q3 – early Q4 of this year; the intended use of proceeds from Goldera’s previously completed financing; estimates of mineralization from drilling; geological information projected from sampling results; and the potential quantities and grades of the target zones.

These forward-looking statements reflect the Company’s current views with respect to future events and are necessarily based upon a number of assumptions that, while considered reasonable by the Company, are inherently subject to significant operational, business, economic and regulatory uncertainties and contingencies. These assumptions include, among other things: conditions in general economic and financial markets; the benefits to be derived from the Company’s proposed exploration programs; accuracy of assay results; geological interpretations from drilling results, timing and amount of capital expenditures; performance of available laboratory and other related services; future operating costs; the historical basis for current estimates of potential quantities and grades of target zones; the availability of skilled labour and no labour related disruptions at any of the Company’s operations; no unplanned delays or interruptions in scheduled activities; all necessary permits, licenses and regulatory approvals for operations are received in a timely manner; the ability to secure and maintain title and ownership to properties and the surface rights necessary for operations; and the Company’s ability to comply with environmental, health and safety laws. The foregoing list of assumptions is not exhaustive.

The Company cautions the reader that forward-looking statements involve known and unknown risks, uncertainties and other factors that may cause actual results and developments to differ materially from those expressed or implied by such forward-looking statements contained in this news release and the Company has made assumptions and estimates based on or related to many of these factors. Such factors include, without limitation: the timing and content of work programs; results of exploration activities and development of mineral properties; the interpretation and uncertainties of drilling results and other geological data; receipt, maintenance and security of permits and mineral property titles; environmental and other regulatory risks; project costs overruns or unanticipated costs and expenses; availability of funds; changes in commodity prices; changes in interest rates; failure to delineate potential quantities and grades of the target zones based on historical data; risks relating to unanticipated operational difficulties (including failure of equipment or processes to operate in accordance with specifications or expectations, cost escalation, unavailability of materials and equipment, government action or delays in the receipt of government or regulatory approvals, industrial disturbances or other job actions, and unanticipated events related to health, safety and environmental matters); risks relating to adverse weather conditions; political risk and social unrest; general market and industry conditions; and those factors identified under the caption “Risks Factors” in the Company’s Form 2B Listing Application dated July 29, 2026.

Forward-looking statements are based on the expectations and opinions of the Company’s management on the date the statements are made. The assumptions used in the preparation of such statements, although considered reasonable at the time of preparation, may prove to be imprecise and, as such, readers are cautioned not to place undue reliance on these forward-looking statements, which speak only as of the date the statements were made. The Company undertakes no obligation to update or revise any forward-looking statements included in this news release if these beliefs, estimates and opinions or other circumstances should change, except as otherwise required by applicable law.

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

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Tegoprubart-treated patients demonstrated a mean improvement on the total MTSOSD-59R symptom occurrence scale at 12 months while tacrolimus-treated patients experienced a mean worsening of symptom occurrence

Statistically significant improvement on the KDQOL-SF Symptoms and Problems Scale among tegoprubart-treated patients through 12 months following kidney transplantation versus tacrolimus

Results further validate the differentiated clinical profile of tegoprubart and potential to transform standard of care in kidney transplantation

IRVINE, Calif., Oct. 26, 2026 (GLOBE NEWSWIRE) — Eledon Pharmaceuticals, Inc. (“Eledon”) (Nasdaq: ELDN) today announced new positive patient-reported outcomes data from the Phase 2 BESTOW clinical trial of tegoprubart, its novel investigational immunosuppression therapy. The data showed significant, sustained improvements in health-related quality of life and symptom burden through 12 months compared with standard of care tacrolimus following kidney transplantation. The results were featured in an oral presentation at the American Society of Nephrology (ASN) Kidney Week 2026 Annual Meeting held October 21-25, 2026, in Denver, Colorado.

“The patient-reported outcomes presented at ASN Kidney Week provide perhaps the clearest picture yet of what tegoprubart’s differentiated profile means for transplant patients in everyday life,” said David-Alexandre C. Gros, M.D., Chief Executive Officer of Eledon. “We previously reported encouraging BESTOW results across efficacy, kidney function and safety measures, which alone strengthened our belief in tegoprubart. The additional findings presented demonstrate that these clinical outcomes were accompanied by substantial and importantly sustained improvements in quality of life and reductions in transplant-related symptom burden. Giving transplant patients an effective, safer and more tolerable alternative to tacrolimus addresses one of the most important unmet needs in organ transplantation, and collectively, these data further support the potential of tegoprubart to become a transformative new treatment option for kidney transplant recipients.”

“Success after kidney transplantation is measured not only by preventing rejection and preserving graft function, but also by how patients feel and function in their everyday lives,” said presenting author Andrew Adams, M.D., Ph.D., Professor of Surgery and Chief, Division of Transplantation, John S. Najarian Surgical Chair in Clinical Transplantation, Department of Surgery, University of Minnesota. “What is particularly compelling about these BESTOW results is the consistency of the patient-reported benefits when treated with tegoprubart compared with tacrolimus following kidney transplant. We observed broad improvements in quality-of-life measures together with remarkably favorable outcomes in transplant-specific symptom reporting. The extent of separation between treatment groups suggests patients receiving tegoprubart may experience meaningful quality of life advantages while maintaining strong clinical outcomes as previously reported from BESTOW.”

Patient-Reported Outcomes Results

Patient-reported outcomes were assessed using the Modified Transplant Symptom Occurrence and Symptom Distress Scale (MTSOSD-59R) and the Kidney Disease Quality of Life Short Form (KDQOL-SF) Symptoms and Problems Scale, both validated measures of symptom burden. Baseline scores were similar between treatment groups. Collectively, the consistency of findings across both the KDQOL-SF and MTSOSD-59R assessments suggests that reductions in transplant-related symptom burden with tegoprubart may contribute to the improvements observed in patient-reported quality of life and further supports the differentiated clinical profile of tegoprubart compared to tacrolimus observed in the Phase 2 BESTOW clinical trial.

On the MTSOSD-59R assessment, tegoprubart-treated patients reported continued reductions in symptom occurrence from baseline at Months 6 and 12, whereas symptom occurrence in the tacrolimus arm initially declined through Month 6 before returning to slightly above baseline levels at Month 12.

Total MTSOSD-59R
Scores represent symptom occurrence
(higher scores reflect greater symptom occurrence)

Total MTSOSD-59R

CI, confidence interval; KDQOL-SF, Kidney Disease Quality of Life Short Form; MTSOSD-59R, Modified Transplant Symptom Occurrence Scale- 59 Items Revised; SEM, standard error of the mean; tac, tacrolimus; tego, tegoprubart.

Tegoprubart demonstrated greater symptom improvement than tacrolimus in 22 of 23 domains where differential improvement was observed, including neurological, gastrointestinal, metabolic, and physical symptom categories. In addition, tacrolimus demonstrated greater symptom worsening in 22 of 22 domains where differential symptom worsening was observed.

On the KDQOL-SF assessment, kidney transplant patients treated with tegoprubart demonstrated improvements from baseline across all five subscales through Month 12. In the KDQOL-SF scale, a change of 3-5 points can be considered clinically significant, and tegoprubart was thus associated with a clinically and statistically significant improvement in the symptoms and problems subscale compared with tacrolimus at Month 12, with mean changes from baseline of 9.0 and 3.3 points, respectively (p<0.05). Consistent with these findings, the SF-12 mental component summary score increased by 1.5 points in the tegoprubart arm compared to a decline of 1.6 points in the tacrolimus arm, representing a 3.1-point between-group difference.

KDQOL-SF: Change from Baseline

a Higher scores indicate better HRQoL; a change of 3–5 points can be considered clinically significant1. Baseline values were similar across all outcomes. *p < 0.05. HRQoL, health-related quality of life; KDQOL-SF, Kidney Disease Quality of Life Short-Form instrument; SEM, standard error of the mean; SF-12, 12-item short-form survey; tac, tacrolimus; tego, tegoprubart.1. KDOQI. Am J Kidney Dis 2007;50:471–530.

Details of the oral presentation at ASN Kidney Week 2026 are below:

Title: Patient-Reported Outcomes in the Phase 2 BESTOW Trial Comparing Tegoprubart to Tacrolimus in Kidney Transplant Recipients
Presenter: Andrew B. Adams, M.D., Ph.D., Department of Surgery, University of Minnesota Medical School; Minneapolis, Minnesota
Abstract Publication Number: FR-OR084
Session Title: The Changing Landscape of Kidney Transplantation: Clinical Innovation, Outcomes, and Healthy Policy
Session Date and Time: Friday, October 23, 2026, from 4:30 p.m. to 6:00 p.m. MDT
Session Room: Mile High Ballroom 4A (Convention Center)
Presentation Time: 4:40 p.m. to 4:50 p.m. MDT

About Eledon Pharmaceuticals and tegoprubart

Eledon Pharmaceuticals, Inc. is a clinical stage biotechnology company that is developing immune-modulating therapies for the management and treatment of life-threatening conditions. The Company’s lead investigational product is tegoprubart, an anti-CD40L antibody with high affinity for the CD40 Ligand, a well-validated biological target that has broad therapeutic potential. The central role of CD40L signaling in both adaptive and innate immune cell activation and function positions it as an attractive target for non-lymphocyte depleting, immunomodulatory therapeutic intervention. The Company is building upon a deep historical knowledge of anti-CD40L biology to conduct preclinical and clinical studies in kidney allograft transplantation, xenotransplantation, islet cell transplantation, liver transplantation and amyotrophic lateral sclerosis (ALS). Eledon is headquartered in Irvine, California. For more information, please visit the Company’s website at www.eledon.com.

Follow Eledon Pharmaceuticals on social media: LinkedIn; X

Forward-Looking Statements

This press release contains forward-looking statements that involve substantial risks and uncertainties. Any statements about the company’s future expectations, plans and prospects, including statements about planned clinical trials, the development of product candidates, expected timing for initiation of future clinical trials, expected timing for receipt of data from clinical trials, as well as other statements containing the words “believes,” “anticipates,” “plans,” “expects,” “estimates,” “intends,” “predicts,” “projects,” “targets,” “looks forward,” “could,” “may,” and similar expressions, constitute forward-looking statements within the meaning of the Private Securities Litigation Reform Act of 1995. Specifically, our ability to achieve our anticipated future development and corporate milestones depends on our ability to obtain additional financing on acceptable terms. Forward-looking statements are inherently uncertain and are subject to numerous risks and uncertainties, including: our short operating history and shifts in our business strategy; our operating losses since inception; our need for additional funding to develop our lead drug candidate and our ability to secure additional funding on acceptable terms or at all; the impact of issuances of our common stock, including in the possibility of dilution or a decline in our stock price; our ability to successfully develop our product candidates; unfavorable global economic and financial market conditions; the regulatory environment of our business and our ability to obtain required regulatory approvals; results of non-clinical studies and clinical trials, and risks that non-clinical studies or early clinical trials may not be predictive of results of later-stage clinical trials; delays or difficulties in enrollment of patients in clinical trials; our ability to attract and retain our executives and key employees; legislation of the pharmaceutical and healthcare industries; cybersecurity and data privacy risks; the ability of our products to achieve marketing approval; competition in our industry; our ability to obtain insurance coverage; our dependence on contract research organizations; our ability to protect our intellectual property; public health crises; our ability to maintain proper and effective internal control over financial reporting and other risks disclosed in our Annual Report on Form 10-K for the year ended December 31, 2025, filed with the Securities and Exchange Commission on March 19, 2026. Actual results may differ materially from those indicated by such forward-looking statements as a result of various factors. These risks and uncertainties, as well as other risks and uncertainties that could cause the company’s actual results to differ materially from the forward-looking statements contained herein, are discussed in our Annual 10-K, and other filings with the U.S. Securities and Exchange Commission, which can be found at www.sec.gov. Any forward-looking statements contained in this press release speak only as of the date hereof and not of any future date, and the company expressly disclaims any intent to update any forward-looking statements, whether as a result of new information, future events or otherwise.

Investor Contact:

Stephen Jasper
Gilmartin Group
(858) 525 2047
stephen@gilmartinir.com

Media Contact:

Jenna Urban
CG Life
(212) 253 8881
jurban@cglife.com

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61% PASI 100 and 86% PASI 90 in the ORKA-001 high-dose (600 mg) group, highly similar to EVERLAST-A

Continued favorable safety and tolerability profile consistent with the IL-23p19 class

ORKA-001 on track to advance into Phase 3 trials in 1H 2027

52-week EVERLAST-A results on track for December 2026

ORKA-002 16-week results from ORCA-SURGE Phase 2 in psoriasis on track for 1Q 2027

Management to host conference call today at 8:00 a.m. ET

MENLO PARK, Calif., Oct. 26, 2026 (GLOBE NEWSWIRE) — Oruka Therapeutics, Inc. (Oruka) (Nasdaq: ORKA), a clinical-stage biotechnology company developing novel biologics designed to set a new standard for the treatment of chronic skin diseases including plaque psoriasis (PsO) and hidradenitis suppurativa (HS), today announced positive Week 16 results from its EVERLAST-B Phase 2b trial of ORKA-001, a novel half-life extended IL-23p19 monoclonal antibody, in moderate-to-severe PsO.

“We are incredibly pleased with the remarkable profile of ORKA-001 observed to date, with highly consistent results achieved across EVERLAST-B and EVERLAST-A. These results further solidify our confidence that ORKA-001 could become the preferred medicine for psoriasis, with high rates of complete skin clearance, a favorable safety profile, and potential for dosing once to twice per year,” said Joana Goncalves, MBChB, Chief Medical Officer of Oruka. “The data shared today support our next step: engaging with regulatory agencies as we advance ORKA-001 towards Phase 3 trials, which we plan to initiate in the first half of next year.”

“These results suggest ORKA-001 is likely to be the most effective IL-23-targeting biologic to date,” said Joel Gelfand, MD, MSCE, FAAD, James J. Leyden Professor of Dermatology and Epidemiology at the University of Pennsylvania and lead investigator for EVERLAST-B. “Virtually all patients could expect to have a very good response, and the majority could expect to achieve completely clear skin within just 16 weeks. The potential for these effects to be long lasting, with just one or two doses a year, would be a paradigm shift in moderate-to-severe psoriasis management, allowing for the trifecta of clear skin, convenience, and excellent safety that would further elevate the standard of care we can offer our patients.”

EVERLAST-B is a randomized, double-blind, placebo-controlled Phase 2b trial evaluating the safety, efficacy, and pharmacokinetics of ORKA-001 in patients with moderate-to-severe PsO. The trial is being conducted across 36 sites in the United States, Canada, and Europe. Less than 30% of these sites participated in EVERLAST-A. EVERLAST-B enrolled 187 patients randomized 1:1:1:1 to receive 37.5 mg ORKA-001 at Week 0 (low dose), 300 mg ORKA-001 at Weeks 0 and 4 (mid dose), 600 mg ORKA-001 at Weeks 0 and 4 (high dose), or placebo. The primary endpoint is PASI 100 at Week 16. At Week 28, patients receiving ORKA-001 who have achieved PASI 100 will be re-randomized 1:1 to either 600 mg ORKA-001 once yearly or placebo. Patients who have not achieved PASI 100 will receive 300 mg ORKA-001 every six months. The study continues through Week 100 to assess durability of response, maintenance dosing, and long-term safety.

Efficacy

Efficacy increased in a dose-dependent manner across ORKA-001 treatment groups, with the high-dose (600 mg) group outperforming both lower dose groups on complete skin clearance. 61% of patients in the high-dose group achieved the primary endpoint of PASI 100 at Week 16, compared to 0% of patients receiving placebo (p<0.0001). The ORKA-001 high-dose group demonstrated high response rates across secondary endpoints, including 86% of patients achieving PASI 90 and IGA 0/1, consistent with the results observed in EVERLAST-A.

Week 16 Placebo
(N=47)
Low dose
(N=47)
Mid dose
(N=47)
High dose
(N=46)
PASI 100 0% 43% 44% 61%
PASI 90 0% 70% 85% 86%
IGA 0/1 0% 74% 85% 86%
 

Safety

ORKA-001 continues to be well tolerated, with a safety profile consistent with the IL-23p19 class. The overall rate of treatment-emergent adverse events (TEAEs) was comparable across groups, with 39% of patients in the high-dose group experiencing at least one TEAE, versus 43% of participants receiving placebo. The only TEAEs occurring in ≥5% of patients treated with ORKA-001 were upper respiratory tract infection and headache, occurring at rates similar to those seen with approved IL-23 inhibitors. No dose-dependent trends in adverse events were observed across ORKA-001 treatment groups, and no injection-site reactions occurred in any patients who received ORKA-001.

Week 0-16 Placebo
(N=47)
Low dose
(N=47)
Mid dose
(N=47)
High dose
(N=46)
All
ORKA-001
(N=140)
≥1 TEAE, n (%) 20 (43%) 22 (47%) 28 (60%) 18 (39%) 68 (49%)
≥1 serious TEAE, n (%) 2 (4%) 1 (2%) 2 (4%) – 3 (2%)
≥1 severe TEAE, n (%) 2 (4%) 1 (2%) 2 (4%) – 3 (2%)
Discontinuation due to
TEAE, n (%)
1 (2%) 1 (2%) 1 (2%) – 2 (1%)
Most frequent TEAEs, n (%)
Upper respiratory tract
infection
4 (9%) 5 (11%) 9 (19%) 6 (13%) 20 (14%)
Headache 1 (2%) 2 (4%) 3 (6%) 3 (7%) 8 (6%)
Injection site reactions, n (%) 1 (2%) – – – –
 

No serious TEAEs occurred in the high-dose group. Serious TEAEs occurring in the other groups were kidney stones, miscarriage, psoriasis, substance-induced psychotic disorder, and syncope following a blood draw and jaw fracture. None were considered treatment related.

Upcoming Milestones for ORKA-001 

Based on the results from the EVERLAST clinical program, the company intends to discuss Phase 3 plans with regulatory authorities. Pending results from those discussions, Oruka plans to initiate Phase 3 trials of ORKA-001 in moderate-to-severe PsO in the first half of 2027 with the high dose (600 mg). In addition, Oruka expects to share 52-week results from EVERLAST-A in December 2026, as well as 52-week results from EVERLAST-B in the second half of 2027.

Webcast Details

Oruka Therapeutics’ live webcast of the EVERLAST-B results will begin today at 8:00 a.m. ET. The live webcast can be accessed via this link,or through the Investors section on the company’s website at https://ir.orukatx.com/news-events/events-presentations. A replay of the webcast will be available following the call.

About Oruka Therapeutics

Oruka Therapeutics is developing novel biologics designed to set a new standard for the treatment of chronic skin diseases. Oruka’s mission is to offer patients suffering from inflammatory diseases like plaque psoriasis and hidradenitis suppurativa the greatest possible freedom from their condition by achieving high rates of disease clearance with dosing as infrequently as once or twice a year. For more information, visit www.orukatx.com and follow Oruka on LinkedIn. 

Forward-Looking Statements

Certain statements in this press release, other than statements of historical fact, are “forward-looking statements” within the meaning of the federal securities laws, including the safe harbor provisions of the Private Securities Litigation Reform Act of 1995. These forward-looking statements include, but are not limited to, statements regarding: the potential therapeutic benefits, efficacy, safety, tolerability, durability of response and dosing profile of ORKA-001; the potential for ORKA-001 to provide durable disease control with infrequent dosing; the planned conduct, progress, timing and results of the EVERLAST-A and EVERLAST-B trials; and the anticipated timing of clinical data readouts and ORKA-001 Phase 3 trial commencement. These forward-looking statements are based on Oruka’s current expectations and beliefs concerning future developments and their potential effects. There can be no assurance that future developments affecting Oruka will be those that have been anticipated. These forward-looking statements involve a number of risks, uncertainties (some of which are beyond Oruka’s control) or other assumptions that may cause actual results or performance to be materially different from those expressed or implied by these forward-looking statements. These risks and uncertainties include, but are not limited to, those uncertainties and factors described under the heading “Risk Factors” and “Cautionary Note Regarding Forward-Looking Statements” in Oruka’s most recent filings with the Securities and Exchange Commission (SEC), including its Annual Report on Form 10-K and Quarterly Reports on Form 10-Q. Should one or more of these risks or uncertainties materialize, or should any of Oruka’s assumptions prove incorrect, actual results may vary in material respects from those projected in these forward-looking statements. Nothing in this press release should be regarded as a representation by any person that the forward-looking statements set forth therein will be achieved or that any of the contemplated results of such forward-looking statements will be achieved. You should not place undue reliance on forward-looking statements in this press release, which speak only as of the date they are made and are qualified in their entirety by reference to the cautionary statements herein and in Oruka’s SEC filings. Oruka does not undertake or accept any duty to make any updates or revisions to any forward-looking statements except as required by applicable law. 

Investor Contact:

Alan Lada
(650) 606-7911
alan.lada@orukatx.com

RICHMOND, Va., Oct. 26, 2026 (GLOBE NEWSWIRE) — ARKO Petroleum Corp. (Nasdaq: APC) (“APC” or the “Company”), one of the largest wholesale fuel distributors by gallons in North America, today announced that the Company will host a conference call on Wednesday, November 4, 2026 at 5:00 p.m. Eastern Time to discuss its financial results for the third quarter ended September 30, 2026.

APC’s management team will host the conference call, followed by a question-and-answer period. The Company will provide its financial results in a press release prior to the call.

Date: Wednesday, November 4, 2026
Time: 5:00 p.m. Eastern Time
Toll-free dial-in number: (877) 407-8306
International dial-in number: (201) 689-8481
Webcast: APC’s Q3 2026 Earnings Call

A telephonic replay will be available approximately three hours after the call concludes through December 2, 2026.

Toll-free replay number: (877) 660-6853
International replay number: (201) 612-7415
Replay ID: 13763511

A link to the live webcast and replay will also be available at https://www.arkopetroleum.com/news-events/ir-calendar.We encourage all participants to register at least 15 minutes prior to the 5:00 p.m. ET start time.

About ARKO Petroleum Corp.

ARKO Petroleum Corp. (Nasdaq: APC) is a growth-oriented, fuel distribution company and one of the largest wholesale fuel distributors by gallons in North America, supplying approximately 2 billion gallons of fuel annually to customers in approximately 3,500 locations in the District of Columbia and more than 30 states across the Mid-Atlantic, Midwestern, Northeastern, Southeastern, and Southwestern United States. We are engaged in (i) wholesale activity, which includes the supply of fuel to gas stations operated by third-party dealers, (ii) fleet fueling, which includes the operation of proprietary and third-party cardlock locations (unstaffed fueling locations) and the issuance of proprietary fuel cards that provide customers access to a nationwide network of fueling sites, and (iii) the wholesale distribution of fuel to substantially all of the retail convenience stores that sell fuel operated by ARKO Corp., our parent company (Nasdaq: ARKO), one of the largest operators of convenience stores in the United States. To learn more about APC, visit: www.arkopetroleum.com.

Company and Investor Contact
Priya Trivedi
ARKO Petroleum Corp.
investors@arkopetroleum.com

MONTREAL, Oct. 26, 2026 (GLOBE NEWSWIRE) — Gildan Activewear Inc. (“Gildan” or the “Company”) today announced it has completed the previously announced sale of HanesBrands Australia (“HAA”) to BBFIT Investments Pte Ltd, an associated entity of BB Retail Capital, a global private investment firm, for approximately $700 million Australian dollars (approximately $490 million US dollars), paid in cash at closing. HAA has been classified as held for sale and reported as discontinued operations in Gildan’s financial statements since the fourth quarter of 2025. Gildan intends to use the net proceeds from the transaction to repay outstanding debt.

“The completion of this transaction represents another important step in the execution of our ongoing integration plan,” said Glenn J. Chamandy, Gildan’s President and CEO. “We remain focused on executing our integration priorities, capturing synergies and leveraging the strength of our brands. We thank the HAA team for its dedication and valuable contributions to the business and wish the entire team continued success under its new ownership.”

Caution Concerning Forward-Looking Statements
Certain statements included in this press release constitute “forward-looking statements” and “forward-looking information” within the meaning of the U.S. Private Securities Litigation Reform Act of 1995 and Canadian securities legislation and regulations and are subject to important risks, uncertainties, and assumptions. These forward-looking statements include, amongst others, statements with respect to our beliefs, plans, expectations, anticipations, estimates, and intentions, including, without limitation, statements regarding the expected use of the net proceeds from the transaction. Forward-looking statements are subject to inherent risks and uncertainties and are based on several assumptions which give rise to the possibility that actual results or events could differ materially from our expectations. Material factors, which could cause actual results or events to differ materially from a conclusion, forecast, or projection in such forward-looking information, include, but are not limited to, those described in the Company’s management discussion and analysis (MD&A) for the year ended December 28, 2025. There can be no assurance that the expectations represented by our forward-looking statements will prove to be correct. Unless otherwise stated, the forward-looking statements contained in this press release are made as of the date of this press release, and we do not undertake any obligation to update publicly or to revise any of the included forward-looking statements, whether as a result of new information, future events, or otherwise unless required by applicable legislation or regulation. The forward-looking statements contained in this press release are expressly qualified by this cautionary statement.

About Gildan
Gildan is a leading manufacturer of everyday basic apparel. The Company’s product offering includes activewear, underwear, socks, and intimates sold to a broad range of customers, including wholesale distributors, screenprinters, embellishers, retailers or e-commerce platforms, as well as global lifestyle brand companies and directly to consumers. Gildan markets its products in North America, Europe, Asia Pacific, and Latin America, under a diversified portfolio of Company-owned brands including Gildan®, Hanes®, Comfort Colors®, American Apparel®, ALLPRO™, GOLDTOE®, Peds®, Bali®, Playtex®, Maidenform®, as well as Champion™ which is under an exclusive licensing agreement for the printwear channel in the U.S. and Canada and Polo Ralph Lauren® also under a licensing agreement.

Gildan owns and operates vertically integrated, large-scale manufacturing facilities which are primarily located in Central America, the Caribbean, North America, and Asia. Gildan integrates industry-leading labour, environmental, and governance practices into its operations and supply chain under a sustainability program that is aligned with its long-term business strategy. More information about Gildan and its sustainability commitments and initiatives can be found at www.gildancorp.com

Investor inquiries:
Jessy Hayem, CFA
Senior Vice-President, Head of Investor Relations and Global Communications
(514) 744-8511
investors@gildan.com
Media inquiries:
Jonathan Binder
Director, Corporate Communications
(336) 519-6330
communications@gildan.com

Partnership combines Pluri’s proprietary cell technology and clinical-development experience with ZEO’s biologics manufacturing expertise, established physician network, and sales, marketing, and educational infrastructure

Pluri and ZEO Scientifix Strategic Agreement

Ian Bothwell, CEO of ZEO, Bob Smoley, Founder of ZEO, Yaky Yanay CEO of Pluri
Ian Bothwell, CEO of ZEO, Bob Smoley, Founder of ZEO, Yaky Yanay CEO of Pluri
  • Established U.S. commercial platform: ZEO contributes biologics manufacturing, scientific expertise, an existing product portfolio, physician relationships, and dedicated sales, marketing, and educational resources.
  • Complementary technology and development capabilities: Pluri brings extensive experience in cell-based product development, clinical experience extending through Phase III trials and scalable manufacturing methods and expertise developed through its proprietary 3D cell-expansion platform.
  • Broader product and clinical-development opportunities: The companies intend to expand commercial offerings, including regenerative aesthetics, and combine scientific resources to strengthen and advance selected clinical programs.
  • Aligned ownership: The transaction and contemplated additional share exchange will result in Pluri owning 50% of ZEO at Closing following the completion of the applicable transaction steps. 

HAIFA, Israel and FORT LAUDERDALE, Fla., Oct. 26, 2026 (GLOBE NEWSWIRE) — Pluri Inc. (Nasdaq and TASE: PLUR) (“Pluri”) and ZEO ScientifiX, Inc. (OTCQB: ZEOX) (“ZEO”) today announced a definitive strategic agreement (“Partnership Agreement”) to expand the parties U.S. manufacturing and commercialization platform serving the regenerative medicine, aesthetics, wellness, and longevity markets.

ZEO brings an established U.S. biologics business combining scientific and manufacturing capabilities with the infrastructure needed to reach and support physicians. Its existing biologics portfolio, substantial physician network, established sales channel, dedicated marketing department, and educational programming provide a foundation for introducing additional products and expanding commercial operations.

Pluri contributes more than two decades of experience in cell-based research, product development, clinical trials, process scale-up, quality systems, and manufacturing. Its proprietary three-dimensional cell-expansion technology and intellectual property support the development and manufacture of cell-based products and its Cellav Health and Aesthetics Ltd.’s (“Cellav”) regenerative aesthetics portfolio.

Together, the companies intend to connect these complementary capabilities to broaden product offerings, expand commercial reach, and strengthen selected regenerative-development programs, subject to applicable regulatory requirements.

Expanding Opportunities in Regenerative Aesthetics

The Partnership Agreement also provides for exclusive U.S. rights to Pluri’s Cellav aesthetic product line, including future offerings. Cellav, Pluri’s wholly owned aesthetics subsidiary, develops cell-derived ingredients and aesthetic products that the companies intend to introduce through ZEO’s commercial platform.

Advanced Product Development

Pluri brings more than two decades of clinical-development expertise, including multinational Phase III trials in muscle recovery following hip-fracture surgery and critical limb ischemia (CLI), supported by extensive scientific and clinical data and an intellectual property portfolio of over 200 patents. By combining Pluri’s accumulated knowledge and development experience with ZEO’s research, manufacturing, and commercial capabilities, the companies aim to develop and bring to market advanced therapeutic products, supported by scientific evidence and informed by extensive clinical data.

Leadership Perspectives

Ian Bothwell, Chief Executive Officer of ZEO ScientifiX commented: “Pluri brings capabilities that are exceptionally valuable to our business: proprietary cell technology, two decades of scientific and clinical experience, and proven expertise in scalable cell manufacturing. We believe combining these strengths with ZEO’s scientific expertise and commercial infrastructure will allow us to expand our product portfolio, accelerate innovation, and pursue opportunities that neither company could address as effectively on its own. We are excited to partner with Pluri and build a stronger platform for the future of regenerative medicine.”

Yaky Yanay, President and Chief Executive Officer of Pluri commented: “ZEO has built something highly valuable: an established U.S. commercial platform with direct access to physicians, an existing advanced product portfolio, and dedicated sales, marketing, and educational capabilities. For Pluri, this creates an important opportunity to connect more than two decades of cell technology, clinical development, and advanced manufacturing expertise with an existing route to market. We believe this partnership can accelerate commercialization, expand our reach in the U.S., and support our ambition to build a growing regenerative medicine business.”

Transaction Overview

Under the Partnership Agreement, Pluri will grant ZEO defined rights to its manufacturing technology and related know-how for associated with its regenerative medicine associated assets, while retaining ownership of its underlying technology and intellectual property. In consideration, ZEO will initially issue shares of its common stock representing 50% of its issued and outstanding common stock immediately following Closing. The Partnership Agreement also provides for warrants, corporate governance and protective rights, among other matters, as well as customary representations and warranties, covenants and indemnifications of the parties.

Following closing, ZEO’s financial results are expected to be consolidated into Pluri’s financial statements, subject to applicable accounting requirements.

Closing of the proposed transaction, which is expected to occur in the fourth quarter of 2026 is subject to satisfaction of a number of conditions, including the negotiation of various ancillary agreements, securing certain approvals and the delivery of valuations, as well as other customary closing conditions. The transaction is not subject to stockholder approval by either Pluri or ZEO.

About Pluri

Pluri™ is a biotechnology company advancing cell-based solutions for health and longevity. Powered by its proprietary 3D cell expansion platform, Pluri develops and manufactures innovative cell-based products designed to address significant unmet medical needs and support healthier, longer lives. With decades of expertise in cell science, clinical development and scalable manufacturing, Pluri is building a portfolio of regenerative and longevity-focused solutions while leveraging its technology and manufacturing capabilities through strategic partnerships. To learn more, visit www.pluri-biotech.com or follow Pluri on LinkedIn and X.

About ZEO ScientifiX

ZEO ScientifiX, Inc. (OTCQB: ZEOX) is a U.S. biopharmaceutical company integrating regenerative biologics research, development, and manufacturing with established commercial operations. Based at Nova Southeastern University’s Center for Collaborative Research in Davie, Florida, ZEO combines scientific and manufacturing expertise with a substantial physician network, dedicated sales and marketing resources, and physician education infrastructure. Through internal development and strategic partnerships, ZEO seeks to expand its product portfolio and advance regenerative medicine. To learn more, visit www.zeoscientifix.com or follow ZEO on LinkedIn, Facebook and Instagram.

Forward-Looking Statements

This release contains forward-looking statements within the meaning of the Private Securities Litigation Reform Act of 1995 and other applicable U.S. securities laws, including statements regarding transaction completion and timing; licensing, ownership, and accounting consolidation; integration; product development and commercialization; clinical programs, and anticipated strategic and financial benefits.

Actual results could differ materially due to risks including failure to complete the transaction; integration challenges; insufficient funding; unsuccessful development, clinical trials, or commercialization; manufacturing and supply issues; competition; and changes in applicable federal and state regulatory requirements. Prior clinical experience does not assure future success.

Additional risks are described in the companies’ respective SEC filings. Neither company undertakes to update forward-looking statements except as required by law.

Contacts

Pluri Investor Relations
investor.relations@pluri-biotech.com

ZEO ScientifiX
investor.relations@zeoscientifix.com

A photo accompanying this announcement is available at https://www.globenewswire.com/NewsRoom/AttachmentNg/200b1de8-e87f-403d-83cc-f13752007908

Active LN patients in the Phase 1 study treated with FT819 and the less-intensive conditioning (bendamustine) regimen selected for the RECLAIM-LN study achieved 100% renal response at Month 6, with approximately 50% mean reduction in proteinuria

Encouraging safety profile with no dose-limiting toxicities, high-grade CRS, ICANS, GvHD or IEC-HS in autoimmune patients treated with a single dose of FT819; low incidences of infection and cytopenia were also observed

Clinical data reinforces the patient value of the ongoing RECLAIM-LN, a Phase 2 potentially registrational study of FT819 in refractory, moderate-to-severe SLE with LN

FT819 continues to offer a unique product profile with the simplicity to dose CAR T-cell therapy on-demand in the community setting

SAN DIEGO, Oct. 26, 2026 (GLOBE NEWSWIRE) — Fate Therapeutics, Inc. (NASDAQ: FATE), a clinical-stage biopharmaceutical company dedicated to bringing a transformative and broadly accessible pipeline of induced pluripotent stem cell (iPSC)-derived cellular immunotherapies to patients with cancer and autoimmune diseases, today announced updated Phase 1 clinical data for FT819, its off-the-shelf, available on-demand, anti-CD19 CAR T-cell product candidate, in patients with systemic lupus erythematosus (SLE) with lupus nephritis (LN) were featured in an oral presentation at the American Society of Nephrology (ASN) Kidney Week 2026, held October 22–25 in Denver, Colorado.

The oral presentation, “Off-the-Shelf Anti-CD19 Chimeric Antigen Receptor (CAR)-T Cell Therapy with Less-Intensive Fludarabine-Free Conditioning in Lupus Nephritis: Phase 1 Safety and Efficacy,” was presented on October 24, 2026, by Jonathan D. Graf, MD, Professor of Clinical Medicine, Division of Rheumatology at the University of California, San Francisco. The presentation reported data from the ongoing Phase 1 FT819-102 study as of the August 18, 2026, data cutoff.

“While these results are early, the initial efficacy and, even more importantly, the safety seen with FT819 is extremely promising,” said Dr. Graf. “In this Phase 1 study, patients receiving even the lowest doses of FT819 are achieving significant clinical responses while showing no signs of serious toxicity. I am extremely excited to see the full results from this study once it is completed and look forward to the Phase 2 trial in LN.”

Across all 29 autoimmune patients, including those with SLE, treated with a single dose of FT819 following less-intensive, fludarabine-free conditioning, FT819 was well tolerated, supporting outpatient administration and expanded patient access. In a cohort of patients with active LN treated with FT819 and bendamustine conditioning, while discontinuing immunosuppressant medications – the regimen selected for the ongoing Phase 2 RECLAIM-LN study – all patients evaluable at Month 6 either achieved a complete renal response (CRR) or primary efficacy renal response (PERR). These outcomes were accompanied by meaningful improvements in lupus disease activity, significant reductions in fatigue, and strong evidence of B-cell reset and remodeling.

“While preliminary, the Phase 1 lupus nephritis clinical efficacy data, concurrent with the discontinuation of standard of care medication such as immunosuppressants, combined with favorable safety data across all patients treated with a single dose of FT819 and less-intensive conditioning, continues to be very encouraging and builds further confidence and momentum in our ongoing RECLAIM-LN study, a Phase 2 potentially registrational trial,” said Bob Valamehr, Ph.D., M.B.A., President and Chief Executive Officer of Fate Therapeutics. “The observed renal responses and favorable safety profile are also complemented with meaningful decreases in lupus disease activity scores and importantly, significant improvement in fatigue scores, a quality-of-life improvement aspect often not achieved with currently approved therapies in lupus nephritis. To be able to deliver such results in an outpatient setting with the on-demand availability of FT819 for broadened patient access is a game changer for patients with this challenging disease who currently lack good treatment options.”

Key findings from the presentation include:

Safety profile – all patients treated (N=29) with a single dose of FT819 with less-intensive conditioning:

  • Favorable safety and tolerability supportive of outpatient delivery. All patients tolerated FT819 with less-intensive conditioning without a dose-limiting toxicity. No immune effector cell-associated neurotoxicity syndrome (ICANS), graft-versus-host disease (GvHD), immune effector cell-associated hemophagocytic lymphohistiocytosis-like syndrome (IEC-HS), or deaths were reported, and no cytokine release syndrome (CRS) above Grade 2 was observed. Low-grade (Grade 1–2) CRS occurred in 5 patients (17.2%). Grade ≥3 infections occurred in 2 patients (6.9%), both urinary tract infections, and Grade ≥3 cytopenias occurred in 6 patients (20.7%). In the U.S., FT819 is being administered in the outpatient setting.

Summary of efficacy and translational data from Phase 1 FT819-102 study as of a data cut-off date of August 18, 2026:  

  • Selected Phase 2 conditioning regimen shows 100% renal response of CRR or PERR and approximately 50% mean reduction in proteinuria at Month 6 in active LN. Patients who were treated with FT819 plus bendamustine and discontinued standard of care therapy per study protocol (hydroxychloroquine and low-dose prednisone permitted) and who had follow up to Month 6 (n=2) achieved a complete renal response (CRR) or primary efficacy renal response (PERR), and mean urine protein-to-creatinine ratio (UPCr), a key measure of kidney damage in LN, decreased by approximately 50% from baseline. The renal response of CRR was sustained through Month 24 in the single patient to reach this timepoint as of the data cutoff date.
  • LN patients in Regimen A show 50% renal response at Month 6. In the broader conditioning cohort, Regimen A (administration of FT819 with less-intensive conditioning consisting of either cyclophosphamide or bendamustine), 50% of Class III or Class IV with or without concomitant Class V LN patients with follow up to Month 6 (n=6) achieved CRR and PERR, respectively. Per study protocol, patients discontinued immunosuppressant medications (hydroxychloroquine and low-dose prednisone permitted) prior to treatment with FT819.
  • Clinically meaningful improvements in disease activity and fatigue. Clinical SLEDAI-2K scores declined as early as Month 1 in both patients with active LN and the overall SLE population (n=11), with reductions maintained in patients with longer follow-up. Physician Global Assessment (PGA), a clinician-rated measure of overall lupus disease activity, fell by approximately 75% from baseline by Month 6. Patient-reported fatigue, measured by FACIT-Fatigue, improved 2-fold from baseline by Month 6, with mean scores moving out of the range associated with moderate-to-severe fatigue.
  • Deep B-cell depletion followed by reconstitution of naïve B cells. FT819 drove durable B-cell depletion (n=11), and concurrently targeted B cells in secondary lymphoid tissue (n=3), indicating activity beyond peripheral blood. During the subsequent B-cell reconstitution, the emerging population reached normal levels for many patients and shifted toward a less-differentiated state at Month 6, with a higher proportion of naïve B cells and a lower proportion of class-switched memory B cells (n=5).
  • Elimination of the top B-cell clones. The 50 most abundant B-cell receptor clones present at baseline were seen to be absent by Month 1 post FT819 treatment and did not re-emerge through Month 6. The elimination of these baseline dominant clones, which may include proliferating disease-driving autoreactive B cells, combined with the reconstitution of a naïve B-cell population, reinforces the remodeling of the B-cell compartment and is suggestive of an immune reset post FT819 treatment.
  • Expanded patient reach and accessibility. FT819 is manufactured from a clonal master cell bank, produced at low cost of goods and is available on demand, with no need to collect and manufacture patient’s own cells, further eliminating patient burden and risk. Combined with less-intensive conditioning that avoids fludarabine, which is cleared by the kidneys and requires dose adjustment in patients with impaired renal function, treatment with FT819 could broaden access to CAR T-cell therapy for patients with LN.

These data support the advancement of FT819 into the ongoing Phase 2 RECLAIM-LN study (FT819-201; NCT07570862) in patients with refractory, moderate-to-severe SLE with lupus nephritis, which uses the same bendamustine conditioning regimen.

About FT819

FT819 is an off-the-shelf CD19-targeting chimeric antigen receptor (CAR) T-cell product candidate engineered to improve safety and efficacy. Analogous to master cell banks used to mass produce biopharmaceutical drug products such as monoclonal antibodies, a precisely engineered clonal master induced pluripotent stem cell (iPSC) bank serves as the starting cell source to manufacture FT819, overcoming numerous limitations associated with patient- and donor-sourced CAR T-cell therapies. FT819 is well-defined and uniform in composition, produced at a low cost of goods, and can be stored in inventory for off-the-shelf, on-demand availability to enable access for a broad patient population. This research was additionally made possible by funding from the California Institute for Regenerative Medicine (CIRM), a state agency in California that supports research in regenerative medicine, stem cell therapy, gene therapy, and clinical trials. (Grant numbers: CLIN2-16303 and CLIN2-20291)

About Fate Therapeutics, Inc.

Fate Therapeutics is a clinical-stage biopharmaceutical company dedicated to bringing a pipeline of induced pluripotent stem cell (iPSC)-derived cellular immunotherapies to patients. Using its proprietary iPSC product platform, the Company has established a leadership position in creating multiplexed-engineered iPSC lines and in the manufacture and clinical development of off-the-shelf, iPSC-derived cell products. The Company’s pipeline includes iPSC-derived T-cell and natural killer (NK) cell product candidates, which are selectively designed, incorporate novel synthetic controls of cell function, and are intended to deliver multiple therapeutic mechanisms to patients. Fate Therapeutics is headquartered in San Diego, CA. For more information, please visit www.fatetherapeutics.com.

Forward-Looking Statements

This release contains “forward-looking statements” within the meaning of the Private Securities Litigation Reform Act of 1995 including statements regarding the Company’s product candidates, clinical studies and preclinical research and development programs, the Company’s progress, plans and timelines for the clinical investigation of its product candidates, including the initiation and continuation of enrollment in the Company’s clinical trials, the initiation of additional clinical trials, including in new indications, and additional dose cohorts in ongoing clinical trials of the Company’s product candidates, the availability of data from the Company’s clinical trials and the Company’s plans to provide updates on its clinical trials, the therapeutic and market potential of the Company’s research and development programs and product candidates, the Company’s clinical and product development strategy, and the Company’s progress and plans relating to, and the anticipated timing and outcome of, interactions with the FDA and other regulatory authorities. These and any other forward-looking statements in this release are based on management’s current expectations of future events and are subject to a number of risks and uncertainties that could cause actual results to differ materially and adversely from those set forth in or implied by such forward-looking statements. These risks and uncertainties include, but are not limited to, the risk that the Company’s research and development programs and product candidates, including those product candidates in clinical investigation, may not demonstrate the requisite safety, efficacy, or other attributes to warrant further development or to achieve regulatory approval, the risk that results observed in prior studies of the Company’s product candidates, including preclinical studies and clinical trials, will not be observed in ongoing or future studies involving these product candidates, the risk of a delay or difficulties in the manufacturing of the Company’s product candidates or in the initiation and conduct of, or enrollment of patients in, any clinical trials, the risk that the Company may cease or delay preclinical or clinical development of any of its product candidates for a variety of reasons (including requirements that may be imposed by regulatory authorities on the initiation or conduct of clinical trials, changes in the therapeutic, regulatory, or competitive landscape for which the Company’s product candidates are being developed, the amount and type of data to be generated or otherwise to support regulatory approval, difficulties or delays in patient enrollment and continuation in the Company’s ongoing and planned clinical trials, difficulties in manufacturing or supplying the Company’s product candidates for clinical testing, failure to demonstrate that a product candidate has the requisite safety, efficacy, or other attributes to warrant further development, and any adverse events or other negative results that may be observed during preclinical or clinical development), the risk that its product candidates may not produce therapeutic benefits or may cause other unanticipated adverse effects, and risks relating to regulatory interactions and the outcome of such interactions. For a discussion of other risks and uncertainties, and other important factors, any of which could cause the Company’s actual results to differ from those contained in the forward-looking statements, see the risks and uncertainties detailed in the Company’s periodic filings with the Securities and Exchange Commission, including but not limited to the Company’s most recently filed periodic report, and from time to time in the Company’s press releases and other investor communications. Fate Therapeutics is providing the information in this release as of this date and does not undertake any obligation to update any forward-looking statements contained in this release as a result of new information, future events or otherwise.

Contact:

Ryan Douglas
Fate Therapeutics, Inc.
IR@fatetherapeutics.com

Primary safety endpoint achieved; exploratory findings highlight encouraging survival outcomes in heavily pretreated patients

One second-line patient achieved progression-free survival of 16.39 months and overall survival exceeding 20.7 months

RAMAT GAN, Israel, Oct. 26, 2026 (GLOBE NEWSWIRE) — Can-Fite BioPharma Ltd. (NYSE American: CANF) (TASE: CANF), a biotechnology company developing small molecule therapeutics targeting cancer and inflammatory diseases, today announced the presentation of final positive data from its Phase IIa clinical study of namodenoson in advanced pancreatic ductal adenocarcinoma at the European Society for Medical Oncology (ESMO) Congress 2026 in Madrid, Spain.

As previously announced, the study achieved its primary safety endpoint, demonstrating that oral namodenoson was well tolerated in patients with advanced pancreatic cancer who had received prior systemic therapies. Exploratory analyses also identified encouraging survival outcomes, supporting further clinical development in this challenging disease.

The single-center, open-label study enrolled 20 patients who received namodenoson at 25 mg twice daily. Fourteen patients received treatment in the third-line setting, three in the second-line setting, and three in the fourth-line setting.

Key findings presented at ESMO included:

  • Primary safety endpoint achieved: Only five adverse events in three patients were considered related or possibly related to namodenoson. All were mild to moderate, Grade 1–2, and none required dose modification, treatment interruption, or discontinuation. No Grade ≥3 treatment-related adverse events or treatment-related serious adverse events were reported.
  • Encouraging third-line survival findings: In a post hoc exploratory analysis of eight third-line patients who survived beyond two months, median overall survival was 6.28 months and median progression-free survival was 2.27 months.
  • Prolonged survival in an individual patient: One second-line patient achieved progression-free survival of 16.39 months and overall survival of 20.7 months, as of the September 23, 2026 data cutoff.

The exploratory third-line analysis focused on patients who survived beyond two months to allow sufficient treatment exposure for evaluation. Because this subgroup was selected based on survival and the study had no randomized comparator, these findings are hypothesis-generating and support evaluation in a larger randomized study.

“These final Phase IIa data provide an encouraging foundation for the continued development of namodenoson in pancreatic cancer,” said Prof. Salomon Stemmer, an oncology key opinion leader and Professor at the Davidoff Institute of Oncology, Rabin Medical Center, Israel “The favourable safety profile, together with the survival findings in heavily pretreated patients and the prolonged clinical course observed in an individual patient, supports advancing our clinical development program. Presenting these results at ESMO provides an important opportunity to share the findings with the international oncology community.”

Namodenoson is an orally administered, selective agonist of the A₃ adenosine receptor, which is highly expressed in tumor and inflammatory cells. Its mechanism involves modulation of growth-regulatory signalling pathways, including Wnt/β-catenin and RAS-associated signalling, and promotion of tumor-cell apoptosis.

The full scientific poster is reproduced below and is available as a downloadable PDF.

About Namodenoson

Namodenoson is a small orally bioavailable drug that binds with high affinity and selectivity to the A3 adenosine receptor (A3AR). Namodenoson is currently being evaluated in a pivotal Phase 3 trial for advanced liver cancer, concluded successfully a Phase 2a study in pancreatic cancer and is enrolling patients in a Phase 2b trial for the treatment of Metabolic Dysfunction-associated Steatohepatitis (MASH). A3AR is highly expressed in diseased cells whereas low expression is found in normal cells. This differential expression may be one of the important factors that accounts for the excellent safety profile of the drug.

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 1,700 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 plans and expectations concerning the further clinical development of namodenoson for pancreatic cancer, the potential design and conduct of future clinical studies, and the potential therapeutic and commercial benefits of namodenoson.. 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

Media Release

COPENHAGEN, Denmark; October 26, 2026

  • Median overall survival (OS) outcomes and encouraging anti-tumor activity observed with petosemtamab plus pembrolizumab in first-line (1L) recurrent or metastatic PD-L1+ head and neck squamous cell carcinoma (r/m HNSCC), with responses observed across HPV-positive and HPV-negative disease
  • Phase 3 program in 1L HNSCC is ongoing, with topline data anticipated later this year

Genmab A/S (Nasdaq: GMAB) today announced updated results from a Phase 2 trial evaluating petosemtamab, an investigational IgG1-bispecific antibody targeting the epidermal growth factor receptor (EGFR) and leucine-rich repeat containing G-protein-coupled receptor 5 (LGR5), in combination with pembrolizumab for first-line (1L) treatment of recurrent/metastatic PD-L1+ head and neck squamous cell carcinoma (r/m HNSCC). In the 1L combination arm, treatment with petosemtamab plus pembrolizumab achieved a median overall survival (OS) of 28.2 months, associated with an overall response rate (ORR) of 63% and median progression free survival (mPFS) of 9.0 months in efficacy-evaluable patients (n=43), including a complete response (CR) rate of 19%. The findings were presented at the European Society for Medical Oncology (ESMO) Congress 2026, held in Madrid, Spain.

“For patients with recurrent or metastatic head and neck squamous cell carcinoma, there is an ongoing need for new treatment approaches that may help expand options beyond currently available regimens,” said Amaury Daste, M.D., Medical Oncologist, Hospital Center University de Bordeaux, France, and study investigator. “The median overall survival of 28 months observed with petosemtamab plus pembrolizumab in this trial, along with a manageable safety profile, are impressive. It is also particularly noteworthy that responses were observed across patient subgroups and continued to be maintained at the time of analysis, an important consideration for patients facing a disease where durable disease control remains a critical treatment goal.”

As of May 15, 2026, median duration of follow-up was 25.5 months; clinical activity was observed across combined positive PD L-1 expression levels and p16 subgroups. With more mature follow-up, the median OS was reached (12-month OS rate, 79%), with an ORR of 63%. Median duration of response (mDOR) was not reached, with an estimated 55% of responders maintaining a response at 24 months. Median PFS was 9.0 months (95% CI, 5.2–12.9; 12-month PFS rate, 40%).

The most common treatment-emergent adverse events (TEAEs) (all grade/Grade 3-4) were asthenia (51%/7%), acneiform dermatitis (51%/7%), and rash (49%/2%). Infusion-related reactions occurred in 38% of patients (7% Grade 3-4), and all resolved. No Grade 5 events nor treatment-related deaths were reported.

“These findings strengthen our confidence in petosemtamab’s potential to make a meaningful difference in first-line head and neck cancer,” said Tahamtan Ahmadi, M.D., Ph.D., Executive Vice President and Chief Medical Officer, Head of Experimental Medicines, Genmab. “Seeing responses across both HPV-positive and HPV-negative disease reinforces our ambition to reach a broad patient population and our commitment to advancing the petosemtamab clinical development program.”

Petosemtamab has the only triple mechanism of action that uniquely targets the LGR5+ stem-like cancer cells that drive tumor recurrence and metastases in epithelial cancers. In addition to this ongoing Phase 1/2 trial (NCT03526835), the petosemtamab clinical program includes four Phase 3 LiGeR trials: in 1L PD-L1+ recurrent or metastatic head and neck squamous cell carcinoma (r/m HNSCC) (LiGeR-HN1; NCT06525220); in 2L/3L r/m HNSCC (LiGeR-HN2; NCT06496178), in 1L RAS/BRAF wild-type, left-sided unresectable or metastatic CRC (LiGeR-CRC1; NCT07702032); and in 2L RAS/BRAF wild-type recurrent, unresectable, or metastatic CRC (LiGeR-CRC2; NCT07775287).

On Wednesday, October 28 at 5:00 p.m. CET/12:00 p.m. EDT, Genmab will host an investor update. To register, visit genmab.com/events-presentations.

About the Phase 2 Petosemtamab Trial (NCT03526835)
The Phase 2 trial (NCT03526835) is an ongoing, open-label, multicenter study evaluating petosemtamab as monotherapy and in combination with pembrolizumab across multiple solid tumors, including head and neck squamous cell carcinoma. In the first-line combination arm, 45 patients were treated with 1500 mg of petosemtamab every two weeks plus 400 mg of pembrolizumab every six weeks until disease progression or unacceptable toxicity. The trial includes a first-line combination cohort evaluating petosemtamab plus pembrolizumab, as well as monotherapy cohorts across later lines of therapy. Primary endpoints include objective response rate (ORR) and safety.

About Head and Neck Squamous Cell Carcinoma (HNSCC)
Head and Neck Squamous Cell Carcinoma (HNSCC) is a group of biologically similar cancers that arise from the tissue lining the surfaces of the oral cavity, pharynx and larynx and represent more than 90% of all head and neck cancers.i It is the seventh most common cancer globally.ii Risk for HNSCC is approximately two to four times higher in men than women.iii Treatment options vary depending on individual factors, including the location of the tumor, stage of the tumor, and a person’s overall health.iii Despite current treatment options, there remains a high patient need for additional therapies, as approximately 50% of patients with locally advanced HNSCC will experience disease recurrence following initial treatment. Recurrent or metastatic HNSCC is associated with a median overall survival of approximately 10-12 months.iv

About Petosemtamab (GEN1158)
Petosemtamab is an investigational human IgG1-based bispecific antibody targeting the EGFR and the LGR5 and designed to support multiple anti-tumor mechanisms. It inhibits EGFR-mediated signaling by engaging a unique site on the receptor to prevent ligand binding. In addition, petosemtamab triggers EGFR degradation in cancer stem-like cells expressing both EGFR and LGR5. Petosemtamab is also engineered to enhance innate immune-mediated activity through interactions with macrophages and natural killer cells. It is currently being investigated in head and neck squamous cell carcinoma (HNSCC) and other solid tumors, including colorectal cancer (CRC). Please visit https://clinicaltrials.gov/ for more information.

About Genmab
Genmab is an international biotechnology company dedicated to improving the lives of people with cancer and other serious diseases through innovative antibody medicines. For over 25 years, its passionate, innovative and collaborative team has advanced a broad range of antibody-based therapeutic formats, including bispecific antibodies, antibody drug conjugate (ADCs), immune-modulating antibodies and other next-generation modalities. Genmab’s science powers eight approved antibody medicines, and the company is advancing a strong late-stage clinical pipeline, including wholly owned programs, with the goal of delivering transformative medicines to patients.

Established in 1999, Genmab is headquartered in Copenhagen, Denmark, with international presence across North America, Europe and Asia Pacific. For more information, please visit Genmab.com or follow us on LinkedIn, X, Facebook and Instagram.

Contact:
David Freundel, Senior Director, Global Communications & Corporate Affairs
T: +1 609 613 0504; E: dafr@genmab.com

Andrew Carlsen, Vice President, Head of Investor Relations
T: +45 3377 9558; E: acn@genmab.com

This Media Release contains forward-looking statements. The words “believe,” “expect,” “anticipate,” “intend” and “plan” and similar expressions identify forward-looking statements. Actual results or performance may differ materially from any future results or performance expressed or implied by such statements. The important factors that could cause our actual results or performance to differ materially include, among others, risks associated with preclinical and clinical development of products, uncertainties related to the outcome and conduct of clinical trials including unforeseen safety issues, uncertainties related to product manufacturing, the lack of market acceptance of our products, our inability to manage growth, the competitive environment in relation to our business area and markets, our inability to attract and retain suitably qualified personnel, the unenforceability or lack of protection of our patents and proprietary rights, our relationships with affiliated entities, changes and developments in technology which may render our products or technologies obsolete, and other factors. For a further discussion of these risks, please refer to the risk management sections in Genmab’s most recent financial reports, which are available on www.genmab.com and the risk factors included in Genmab’s most recent Annual Report on Form 20-F and other filings with the U.S. Securities and Exchange Commission (SEC), which are available at www.sec.gov. Genmab does not undertake any obligation to update or revise forward looking statements in this Media Release nor to confirm such statements to reflect subsequent events or circumstances after the date made or in relation to actual results, unless required by law.

Genmab A/S and/or its subsidiaries own the following trademarks: Genmab®; the Y-shaped Genmab logo®; Genmab in combination with the Y-shaped Genmab logo®; HuMax®; DuoBody®; HexaBody®; DuoHexaBody®, HexElect®, and KYSO®.


i Johnson DE, Burtness B, Leemans CR, Lui VWY, Bauman JE, Grandis JR. “Head and neck squamous cell carcinoma.” Nat Rev Dis Primers, 2020 Nov 26;6(1):92. doi: 10.1038/s41572-020-00224-3. Erratum in: Nat Rev Dis Primers. 2023 Jan 19;9(1):4. doi: 10.1038/s41572-023-00418-5. PMID: 33243986; PMCID: PMC7944998.
ii Barsouk A, Aluru JS, Rawla P, Saginala K, Barsouk A. “Epidemiology, Risk Factors, and Prevention of Head and Neck Squamous Cell Carcinoma.” Med Sci (Basel), 2023 Jun 13;11(2):42. doi: 10.3390/medsci11020042. PMID: 37367741; PMCID: PMC10304137.
iii Cancer Research Institute. “Head and Neck Cancer a Promising Treatment?” Accessed June 4, 2026. https://www.cancerresearch.org/immunotherapy-by-cancer-type/head-and-neck-cancer.
iv Ionna F, Bossi P, Guida A, Alberti A, Muto P, Salzano G, Ottaiano A, Maglitto F, Leopardo D, De Felice M, Longo F, Tafuto S, Della Vittoria Scarpati G, Perri F. “Recurrent/Metastatic Squamous Cell Carcinoma of the Head and Neck: A Big and Intriguing Challenge Which May Be Resolved by Integrated Treatments Combining Locoregional and Systemic Therapies.” Cancers (Basel), 2021 May 14;13(10):2371. doi: 10.3390/cancers13102371. PMID: 34069092; PMCID: PMC8155962.

Media Release no. 15
CVR no. 2102 3884
LEI Code 529900MTJPDPE4MHJ122

Genmab A/S
Carl Jacobsens Vej 30
2500 Valby
Denmark

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