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First Atlantic Nickel & Cobalt Raises Total of $13.4 Million with Additional $3.49 Million No-Warrant, Non-Brokered Private Placement at $0.83 per Share, a Premium to Market, to Accelerate Exploration at Pipestone XL Nickel-Cobalt Alloy Project

Posted on October 6, 2026 by Ravi Shankar

GRAND FALLS-WINDSOR, Newfoundland and Labrador, Oct. 06, 2026 (GLOBE NEWSWIRE) — First Atlantic Nickel & Cobalt Corp. (TSXV: FAN) (OTCQB: FANCF) (FSE: P210) (“First Atlantic” or the “Company”) is pleased to announce that it has closed a no-warrant, non-brokered private placement (the “Offering”) for aggregate gross proceeds of $3,492,000.90. Following this closing, the Company has raised aggregate gross proceeds of approximately $13.4 million from financings completed since September 2026. The Offering consisted of 4,207,230 flow-through common shares of the Company (each, an “FT Share”) issued at a price of $0.83 per FT Share. The price of $0.83 per FT Share represents a premium of approximately 22% to the closing price of the Company’s common shares on the TSX Venture Exchange (the “Exchange”) on October 5, 2026. Each FT Share qualifies as a “flow-through share” within the meaning of subsection 66(15) of the Income Tax Act (Canada). No warrants were issued in connection with the Offering.

“Since September, First Atlantic has raised approximately $13.4 million, including this $3.49 million financing, a very significant development for the Pipestone XL Nickel-Cobalt Alloy Project that will accelerate our exploration and mining development. The funds allow us to significantly expand drilling at Alloy Max and the RPM Zone, drill new targets along the 30-kilometre trend that have never been tested, and develop the exploration access road north toward Atlantic Lake, opening areas that until now could only be reached by helicopter.”

“North America has limited smelting capacity to meet future nickel and cobalt demand. Pipestone XL is a significant, large-scale ophiolite complex approximately 30 kilometres long, where awaruite occurs disseminated in the ultramafic host rock over large areas. It has the potential to be a large source of both metals without smelting, moving directly into downstream refining and bypassing that midstream processing constraint. It is a scalable, environmentally sustainable solution that supports a resilient supply chain and reduces reliance on foreign offshore smelting.”

Adrian Smith, P.Geo., CEO of First Atlantic Nickel & Cobalt Corp.

First Atlantic welcomes calls directly from shareholders and prospective investors. For questions about the Company or the Pipestone XL project, or simply to learn more, investors are invited to call Rob Guzman, Investor Relations, at +1-844-592-6337 or email rob@fanickel.com.

This funding will allow the Company to significantly expand exploration and infill drilling at the Alloy Max and RPM Zones. It will also allow the Company to drill new, previously untested targets and areas of the project that have never been drilled.

The funding will also allow the Company to develop the full exploration access road that will eventually connect Grand Falls-Windsor to the historic Atlantic Lake Zone, designed to follow the magnetic anomaly further north inside the 30-kilometre nickel trend of the Pipestone Ophiolite Complex. As the road is developed, exploration and bedrock stripping along the route will test for additional occurrences of visible awaruite and potential new drill targets, as the Company aims to develop a multi-pit resource at the Pipestone XL Nickel-Cobalt Alloy Project. In each case, these expenditures will be funded only to the extent they qualify as Qualifying Expenditures (as defined below).

PIPESTONE XL: A DISTRICT-SCALE NICKEL-COBALT ALLOY PROJECT

Pipestone XL is First Atlantic’s wholly owned, district-scale project spanning the entire 30-kilometre Pipestone Ophiolite Complex in central Newfoundland, a belt of ultramafic rock enriched in nickel, cobalt, and chromium. The Project hosts multiple zones of awaruite (Ni₃Fe) mineralization, including RPM, Alloy Max, Super Gulp, Atlantic Lake, and Chrome Pond. The RPM Zone is the most advanced, with drilling having outlined magnetically recoverable awaruite over more than 1.2 kilometres of strike and more than 800 metres of width. Drilling is ongoing at Alloy Max, a second large-scale zone spanning approximately 4 kilometres of strike and up to 1.5 kilometres in width, making it larger than the RPM Zone.

Awaruite at Pipestone XL is the product of serpentinization, which drove sulphur out of the system and left a sulphur-free alloy which carries no acid mine drainage risk and can be concentrated by the Company’s ONSHORE MAX™ process without smelting, roasting, or high-pressure acid leaching. This smelter-free pathway addresses the midstream bottleneck in North America, where the United States has no operating nickel smelters and only two remain in Canada, and supports a vertically integrated supply chain moving directly from mine to downstream battery refining, stainless steel and specialty alloy production. The Company is also evaluating secondary chromium mineralization as a potential co-product, along with low-carbon Engineered Mineral Hydrogen (EMH) in partnership with VEMA Hydrogen¹. Investors can learn more about VEMA’s Engineered Mineral Hydrogen at https://www.vema.earth.

First Atlantic Nickel & Cobalt

Figure 1: Map showing multiple target zones across the 30-kilometer nickel trend over total magnetic intensity (TMI) at the Pipestone XL Project highlighting the showing, the 30-kilometre Pipestone Ophiolite Complex and the RPM, Alloy Max, Super Gulp, Atlantic Lake and Chrome Pond Zones.

Pipestone XL is located in an established infrastructure corridor with year-round road access, nearby high-voltage transmission and clean hydroelectric power from the Bay d’Espoir generating station. It is also located approximately 200 kilometres from Gander International Airport and Vale’s Long Harbour nickel processing plant. This positioning aligns with growing U.S. and allied policy focus on critical mineral supply chains, including nickel’s addition to the U.S. critical minerals list in 2022, the January 2026 White House proclamation on processed critical minerals², the Company’s acceptance into the U.S. Defense Industrial Base Consortium³, and the June 2026 G7 Leaders’ Declaration naming nickel one of two pilot critical minerals for allied investment and offtake⁴.

Newfoundland and Labrador is consistently recognized as one of the world’s leading mining jurisdictions in the Fraser Institute’s Annual Survey of Mining Companies, ranking 7th globally on the Policy Perception Index in the most recent survey, published in February 2026, and placing in the global top 10 for overall investment attractiveness in each of the three prior surveys. Pipestone XL is positioned to become a secure and reliable North American source of nickel and cobalt for the stainless steel, electric vehicle, aerospace, and defense industries.

AWARUITE AT PIPESTONE XL: A SMELTER-FREE NICKEL-COBALT ALLOY (Ni₃Fe)

Awaruite is a naturally occurring, magnetic, sulphur-free nickel-iron-cobalt alloy (Ni₃Fe) containing approximately 77% nickel. Because it already exists in a metallic state, awaruite can be concentrated without smelting, roasting, or high-pressure acid leaching. Mineralogical and electron microprobe analysis at the Company’s RPM Zone has confirmed the awaruite averages 77.62% nickel and 1.69% cobalt, with grades as high as 86.68% nickel and 6.05% cobalt⁵.

Initial metallurgical test work using the Company’s ONSHORE MAX™ (Magnetic Alloy eXtraction) process upgraded rock samples from the project’s RPM Zone into a high-grade alloy concentrate averaging 67.4% nickel and grading up to 71.9% nickel and 1.76% cobalt⁶. Low-intensity magnetic separation first produced a magnetic concentrate grading approximately 1.6% nickel, which flotation then upgraded to the final concentrate. By comparison, a typical nickel concentrate grades 10% to 15% nickel, according to the Nickel Institute. This concentrate can move directly to downstream battery chemical refining or the manufacture of specialty alloys and stainless steel.

The absence of sulphur reduces acid mine drainage risk and related permitting challenges, positioning Pipestone XL to supply North American industries including stainless steel, electric vehicles, aerospace, and defence.

First Atlantic Nickel & Cobalt

Figure 2: USGS quote on awaruite nickel-iron-cobalt alloy.⁷

The gross proceeds of the Offering will be used to incur eligible “Canadian exploration expenses” that qualify as “flow-through mining expenditures,” as those terms are defined in the Income Tax Act (Canada) (the “Qualifying Expenditures”), in connection with the exploration programs described above at the Company’s Pipestone XL Nickel-Cobalt Alloy Project and exploration activities at its Ophiolite X Project in Newfoundland. The Company will incur the Qualifying Expenditures on or before December 31, 2027 and renounce them in favour of subscribers effective December 31, 2026.

All securities issued in connection with the Offering are subject to a statutory hold period of four months and one day, expiring on February 6, 2027, under applicable Canadian securities laws. The Offering remains subject to final acceptance by the Exchange.

No finder’s fees were paid in connection with the Offering.

This news release does not constitute an offer to sell or a solicitation of an offer to buy any securities in the United States. The securities have not been and will not be registered under the United States Securities Act of 1933, as amended (the “U.S. Securities Act”), or any applicable state securities laws, and may not be offered or sold within the United States or to U.S. persons unless registered under the U.S. Securities Act and applicable state securities laws, or an exemption from such registration is available.

INVESTOR INFORMATION

The Company’s common shares trade on the TSX Venture Exchange under the symbol “FAN”, on the OTCQB under the symbol “FANCF”, and on several German exchanges, including Frankfurt and Tradegate, under the symbol “P210”. Investors can get updates about First Atlantic by signing up to receive news via email and SMS text at www.fanickel.com.

FOR MORE INFORMATION

First Atlantic Investor Relations, Robert Guzman. Tel: +1-844-592-6337 | Email: rob@fanickel.com

QUALIFIED PERSON

Adrian Smith, P.Geo., a director and the Chief Executive Officer of the Company, is a qualified person as defined by NI 43-101. The qualified person is a member in good standing of the Professional Engineers and Geoscientists Newfoundland and Labrador (PEGNL) and is a registered professional geoscientist (P.Geo.). Mr. Smith has reviewed and approved the technical information disclosed herein.

ABOUT FIRST ATLANTIC NICKEL & COBALT CORP.

First Atlantic Nickel & Cobalt Corp. (TSXV: FAN | OTCQB: FANCF | FSE: P210) is a critical mineral exploration company in Newfoundland and Labrador developing the Pipestone XL Nickel-Cobalt (Ni-Fe-Co) Alloy Project. The project spans the entire 30-kilometre Pipestone Ophiolite Complex, where multiple zones, including RPM, Alloy Max, Super Gulp, Atlantic Lake and Chrome Pond, contain awaruite (Ni₃Fe), a naturally occurring magnetic nickel-iron-cobalt alloy of approximately 77% nickel with no sulphur and no sulphides, along with secondary chromium mineralization. Awaruite’s sulphur-free composition removes acid mine drainage risk, while its magnetic properties enable processing through magnetic separation and flotation, eliminating the electricity requirements, emissions and environmental impacts of conventional smelting, roasting or high-pressure acid leaching, while reducing dependence on overseas nickel processing infrastructure.

The U.S. Geological Survey recognized awaruite’s strategic importance in its 2012 Annual Report on Nickel⁸, noting that these deposits may help alleviate prolonged nickel concentrate shortages since the natural alloy is much easier to concentrate than typical nickel sulphide. In 2026, initial metallurgical test work using the Company’s ONSHORE MAX™ (Magnetic Alloy eXtraction) process upgraded RPM Zone material into a high-grade alloy concentrate averaging 67.4% nickel and grading up to 71.9% nickel and 1.76% cobalt, demonstrating a smelter-free, mine-to-refinery pathway. First Atlantic is a member of the U.S. Defense Industrial Base Consortium. The Company is also advancing a parallel geologic hydrogen initiative at Pipestone XL, where the same serpentinization process that formed awaruite also generates natural hydrogen, and has signed a letter of intent with VEMA Hydrogen to jointly develop low-carbon Engineered Mineral Hydrogen (EMH) through a proposed 50/50 joint venture. The Pipestone XL project is located near existing infrastructure with year-round road access and proximity to hydroelectric power, providing favorable logistics for exploration and future development and strengthening First Atlantic’s role to establish a secure and reliable source of North American nickel and cobalt production for the stainless steel, electric vehicle, aerospace, and defense industries. This mission gained importance when the U.S. added nickel to its critical minerals list in 2022, recognizing it as a non-fuel mineral essential to economic and national security with a supply chain vulnerable to disruption.

Neither the 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 release.

Forward looking statements

Certain information contained in this news release constitutes “forward-looking information” or “forward-looking statements” within the meaning of applicable Canadian securities legislation (collectively, “forward-looking information”). Forward-looking information is often identified by words such as “anticipates,” “believes,” “expects,” “intends,” “plans,” “may,” “will,” “potential,” and similar expressions.

Forward-looking information in this news release includes statements regarding: final acceptance of the Offering by the Exchange; the intended use of proceeds, the qualification of expenditures as Canadian exploration expenses and flow-through mining expenditures, the incurrence of those expenditures by December 31, 2027 and their renunciation in favour of subscribers effective December 31, 2026; the scope, timing and anticipated results of exploration and metallurgical programs at the Pipestone XL Nickel-Cobalt Alloy Project and Ophiolite X Project, including district-scale drilling, the development of an exploration access road toward the historic Atlantic Lake Zone and exploration and bedrock stripping along its route; expansion and infill drilling at the Alloy Max and RPM Zones, drilling of previously untested targets and the identification of new drill targets; the Company’s aim to develop a multi-pit resource at the Pipestone XL Nickel-Cobalt Alloy Project; the potential capabilities, scalability and benefits of the ONSHORE MAX™ process; the potential to concentrate awaruite without smelting, roasting or high-pressure acid leaching; the suitability of concentrates for downstream refining and the manufacture of battery chemicals, specialty alloys and stainless steel; potential environmental and permitting benefits; and the potential for Pipestone XL to supply North American industrial markets.

This forward-looking information is based on management’s current expectations and assumptions, including that required regulatory approvals will be obtained; planned expenditures will satisfy applicable tax requirements and be incurred and renounced within the specified timelines; necessary permits, personnel, contractors, equipment and laboratory capacity will be available; exploration and metallurgical programs can be completed within anticipated budgets and schedules; the exploration access road can be developed along the planned route within anticipated budgets and schedules; further testing will support the applicability of initial metallurgical results to representative project material and larger-scale operations; any resulting concentrates will meet relevant downstream processing and customer specifications; and that further environmental studies will support the anticipated environmental benefits.

Forward-looking information is subject to risks and uncertainties that could cause actual results to differ materially from those expressed or implied. These include failure to obtain regulatory approvals or complete additional financing; changes in market conditions, commodity prices, costs or the availability of financing; failure to incur sufficient qualifying expenditures within the required period, adverse tax determinations or changes in tax laws or their interpretation; exploration results that do not support anticipated mineralization or expansion targets; exploration results that do not support the delineation of mineral resources; permitting, access, cost or construction delays affecting development of the exploration access road; geological and metallurgical variability; the preliminary nature of test results and the risk that such results cannot be replicated at larger scale or achieved economically; concentrate impurities, recovery limitations or failure to meet downstream specifications; permitting delays, environmental liabilities and findings that differ from anticipated environmental benefits; operational, weather, equipment, contractor and laboratory delays; and other risks described in the Company’s continuous disclosure filings available on SEDAR+ at www.sedarplus.ca.

Initial metallurgical results do not establish commercial viability or guarantee future recoveries, concentrate quality or processing performance. There can be no assurance that the anticipated exploration, processing, environmental or commercial outcomes will be achieved.

Although management considers its expectations and assumptions reasonable as of the date of this news release, forward-looking information is not a guarantee of future performance. Readers are cautioned not to place undue reliance on it. Except as required by applicable securities laws, the Company undertakes no obligation to update forward-looking information to reflect subsequent events, circumstances or changes in expectations.

^¹ https://fanickel.com/20260608-vema-hydrogen-and-first-atlantic-nickel-cobalt-sign-loi-to-develop-engineered-mineral-hydrogen-at-pipestone-xl-awaruite-project-in-newfoundland
^² https://fanickel.com/20260115-first-atlantic-nickel-highlights-relevance-of-pipestone-xl-awaruite-nickel-cobalt-alloy-discovery-to-address-u-s–critical-mineral-supply-chain-vulnerabilities-identified-in-january-14-2026-white-house-proclamation
^³ https://fanickel.com/20260331-first-atlantic-nickel-announces-acceptance-into-defense-industrial-base-consortium-dibc—pipestone-xl-smelter-free-nickel-cobalt-alloy-project-addresses-midstream-smelting-bottleneck-in-u-s–defense-supply-chain
^⁴ https://fanickel.com/20260619-first-atlantic-nickel-cobalt-highlights-g7-leaders-declaration-on-critical-minerals-g7-names-nickel-one-of-only-two-pilot-minerals-for-a-new-allied-traceability-framework-moves-to-mobilize-equity-investment-and-offtake-and-establishes-a-critical-
^⁵ https://fanickel.com/20260521-first-atlantic-nickel-cobalt-reports-electron-microprobe-analysis-returning-77-62-nickel-and-1-69-cobalt-in-awaruite-at-the-rpm-zone-pipestone-xl-project-a-rare-naturally-magnetic-ni-fe-co-high-grade-alloy-mineralogically-capable-of-bypassing-mid
^⁶ https://fanickel.com/20260624-first-atlantic-nickel-cobalt-produces-high-grade-alloy-concentrate-up-to-71-9-nickel-and-1-76-cobalt-from-its-pipestone-xl-nickel-cobalt-alloy-project-using-its-first-ever-onshore-max-magnetic-alloy-extraction-recovery-concentration-process-unvei
^⁷ https://d9-wret.s3.us-west-2.amazonaws.com/assets/palladium/production/mineral-pubs/nickel/mcs-2012-nicke.pdf
^⁸ https://d9-wret.s3.us-west-2.amazonaws.com/assets/palladium/production/mineral-pubs/nickel/mcs-2012-nicke.pdf

Photos accompanying this announcement are available at:
https://www.globenewswire.com/NewsRoom/AttachmentNg/448ace60-5570-46e8-a872-d671bdc932ad
https://www.globenewswire.com/NewsRoom/AttachmentNg/c98b10b1-2d62-453b-9af8-3491ba8675ae

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Zenas BioPharma to Host Virtual R&D Event

Posted on October 6, 2026 by Ravi Shankar

WALTHAM, Mass., Oct. 06, 2026 (GLOBE NEWSWIRE) — Zenas BioPharma, Inc. (“Zenas” or the “Company”) (Nasdaq: ZBIO), a clinical-stage global biopharmaceutical company committed to being a leader in the development and commercialization of transformative therapies for patients living with autoimmune and inflammatory diseases, today announced that it will host a virtual R&D event on Tuesday, October 27, 2026, from 8:00 – 9:30 a.m. ET.

The event will include presentations from Zenas’ management team on the overall R&D pipeline including obexelimab, our investigational bifunctional monoclonal antibody targeting CD19 and FcyRIIb, currently being evaluated in systemic lupus erythematosus, as well as the ongoing development of ZB021, Zenas’ oral IL-17AA/AF inhibitor. Dr. Joseph F. Merola, MD, MMSc, Dermatologist, Rheumatologist, President of the Rheumatologic Dermatology Society, Medical and Scientific Board of the Lupus Foundation of America, will provide key insights into the biology and clinical considerations.

Conference Call Information

To access the live webcast of the call, please visit the “Events and Presentations” page in the Investor & Media Relations section of the Zenas BioPharma website. A replay of the webcast will be available following the call.

About Zenas BioPharma, Inc.
Zenas is a clinical-stage global biopharmaceutical company focused on the development and commercialization of therapies for autoimmune diseases and inflammatory conditions. Zenas combines our experienced leadership team with a disciplined global product candidate acquisition approach to identify, acquire and develop product candidates with the potential to deliver clinically meaningful benefits to patients. Zenas is advancing two late-stage, potential franchise molecules, obexelimab and orelabrutinib. Obexelimab, Zenas’ lead product candidate, is a bifunctional monoclonal antibody designed to bind CD19 and FcγRIIb to inhibit the activity of B cells implicated in many autoimmune diseases without depleting them. Zenas believes that the unique mechanism of action of obexelimab and its self-administered, subcutaneous injection regimen may enable sustained control across multiple chronic autoimmune diseases. Orelabrutinib is a potentially best-in-class, highly selective CNS-penetrant, oral, small molecule BTK inhibitor. Orelabrutinib’s mechanism of action targets pathogenic B cells not only in the periphery but also within the CNS. Additionally, it directly modulates macrophages and microglial cells in the CNS, with the potential to address compartmentalized inflammation and disease progression in MS. Zenas’ earlier stage programs include ZB021, a novel, potentially best-in-class, oral, IL-17AA/AF inhibitor, ZB022, a preclinical, potentially best-in-class, oral, brain-penetrant, TYK2 inhibitor, and ZB014, a preclinical, half-life extended anti-CD19 and FcγRIIb monoclonal antibody. For more information about Zenas BioPharma, please visit https://zenasbio.com/ and follow us on LinkedIn.

Forward-Looking Statements
This press release contains “forward-looking statements.” In some cases, forward-looking statements can be identified by terms such as “may,” “will,” “should,” “expect,” “plan,” “anticipate,” “could,” “intend,” “target,” “project,” “contemplate,” “believe,” “estimate,” “predict,” “potential” or “continue” or the negative of these terms or other similar expressions, although not all forward-looking statements contain these words. Forward-looking statements are neither historical facts nor assurances of future performance. Instead, they are based on our current beliefs, expectations, and assumptions. All statements other than statements of historical facts contained in this press release are forward-looking statements. Forward looking statements include, but are not limited to, the anticipated timing or likelihood of regulatory submissions and approvals, and the outcome of interactions with regulatory authorities; the therapeutic potential of the Company’s product candidates; the Company’s expectations regarding the potential commercialization, estimated market size and market opportunities of its product candidates; and the timing of reporting the topline results of obexelimab in SLE. The forward-looking statements in this press release speak only as of the date of this press release and are subject to a number of known and unknown risks, uncertainties and assumptions that could cause the Company’s actual results, performance or achievements to differ materially from those anticipated in the forward-looking statements. These risks and uncertainties include, but are not limited to: the Company’s limited operating history, incurrence of substantial losses since the Company’s inception and anticipation of incurring substantial and increasing losses for the foreseeable future; the Company’s need for substantial additional financing to achieve the Company’s goals; the uncertainty of clinical development; potential competition, including from large and specialty pharmaceutical and biotechnology companies; the Company’s ability to realize the benefits of the Company’s current or future collaborations or licensing arrangements; the Company’s ability to obtain regulatory approval to commercialize its product candidates; risks related to the manufacturing of the Company’s product candidates and the risk that the Company’s third-party manufacturers may encounter difficulties in production; the Company’s ability to obtain and maintain sufficient intellectual property protection for the Company’s product candidates; the Company’s reliance on third parties to conduct the Company’s preclinical studies and clinical trials; the Company’s compliance with the its license obligations; significant political, trade, and regulatory developments, including changes in relations between the U.S. and China; risks related to the operations of the Company’s suppliers, many of which are located outside of the United States, including the Company’s current sole contract manufacturing organization for obexelimab drug substance and drug product, WuXi Biologics (Hong Kong) Limited, and our partner, InnoCare, both of which are located in China; the risk that the Company’s indebtedness could adversely affect the Company’s financial condition or restrict the Company’s future operations; and other risks and uncertainties described in the section “Risk Factors” in the Company’s Annual Report on Form 10-K for the year ended December 31, 2025, as supplemented from time to time by our subsequent filings with the Securities and Exchange Commission (the “SEC”), as well as other information we file with the SEC. The forward-looking statements in this press release are based upon information available to the Company as of the date of this press release and while the Company believes such information forms a reasonable basis for such statements, such information may be limited or incomplete. Because forward-looking statements are inherently subject to risks and uncertainties, these forward-looking statements should not be relied upon as guarantees of future events. Moreover, the Company operates in an evolving environment. New risks and uncertainties may emerge from time to time, and management cannot predict all risks and uncertainties. Except as required by applicable law, the Company does not undertake to publicly update or revise any forward-looking statements contained herein, whether as a result of any new information, future events, changed circumstances or otherwise.

Contacts:

Investors:
Argot Partners
Zenas@argotpartners.com

Media:
Kristin Ainsworth
SVP, U.S. Commercial Strategy & Corporate Affairs
612.839.6748

Posted in UncategorizedTagged GlobeNewswire

Zenas BioPharma to Host Virtual R&D Event

Posted on October 6, 2026 by Ravi Shankar

Conference Call Information

Contacts:

Investors:
Argot Partners
Zenas@argotpartners.com

Media:
Kristin Ainsworth
SVP, U.S. Commercial Strategy & Corporate Affairs
612.839.6748

Posted in UncategorizedTagged GlobeNewswire

ProMIS Neurosciences Appoints Seasoned Alzheimer’s and Neuroscience Executive Ivana Rubino, Ph.D., as Chief Commercial Officer

Posted on October 6, 2026 by Ravi Shankar

Former senior Biogen and Roche executive brings deep experience across Alzheimer’s clinical development, launch readiness, commercialization and global medical strategy

Appointment strengthens commercial and development leadership as PMN310 advances toward 12-month topline data expected in Q1 2027

CAMBRIDGE, Mass.,, Oct. 06, 2026 (GLOBE NEWSWIRE) — ProMIS Neurosciences Inc. (Nasdaq: PMN) (“ProMIS” or the “Company”), a clinical-stage biotechnology company developing therapeutics targeting toxic misfolded proteins in neurodegenerative diseases, including Alzheimer’s disease, today announced the appointment of Ivana Rubino, Ph.D., as Chief Commercial Officer, effective October 5, 2026.

Dr. Rubino brings more than 15 years of global biopharmaceutical leadership experience, with deep expertise in neuroscience and particularly in Alzheimer’s disease, spanning clinical development strategy, medical affairs, launch readiness, market development and commercialization. During her time at Biogen and F. Hoffmann-La Roche, Dr. Rubino led and helped shape Alzheimer’s disease programs across late-stage development, scientific and medical strategy, market preparation and commercialization planning. Her experience includes global leadership supporting the LEQEMBI® franchise, preparation for next-generation Alzheimer’s therapies, and the build-out of large global medical organizations across the United States, Europe and other major markets. She also held senior global leadership roles across multiple sclerosis, spinal muscular atrophy and neuropsychiatry.

“Ivana joins ProMIS at an important point in the evolution of PMN310 and our Alzheimer’s program,” said Neil Warma, President and Chief Executive Officer of ProMIS Neurosciences. “She brings a rare combination of scientific depth and experience advancing major Alzheimer’s programs through launch readiness and commercialization at Biogen and Roche. Ivana’s broad neuroscience and strategic experience will help us build the capabilities needed for ProMIS’ next stage of growth, and her extensive background in Alzheimer’s disease will be particularly valuable as we move toward our 12-month PRECISE-AD topline readout of PMN310 in the first quarter of 2027.”

As Chief Commercial Officer, Dr. Rubino will lead ProMIS’ commercial and market preparation strategy for PMN310, including market access and payer planning, patient and physician pathway development, key opinion leader and advocacy engagement, launch readiness and lifecycle strategy. She will also work closely with the Chief Medical Officer on pivotal development strategy and evidence generation, and will contribute to regulatory strategy, business development and the positioning of ProMIS’ broader neuroscience pipeline.

“Neuroscience has been at the center of my career, and I have had the privilege of working across several areas in which major scientific advances have transformed what is possible for patients,” said Dr. Rubino. “Alzheimer’s disease is perhaps one of the clearest examples: although we have made significant progress, meaningful scientific, clinical and access challenges remain. What attracted me to ProMIS was both the differentiated science behind PMN310 and the broader potential of the company’s approach to targeting toxic misfolded proteins. If the clinical data in the ongoing Alzheimer’s trial continue to be supportive, PMN310 could represent an important next step in Alzheimer’s treatment. I am excited to help translate the science into development and commercial strategies that can ultimately create meaningful value for patients, families and the neuroscience community.”

Dr. Rubino joins ProMIS from Biogen, where she most recently served as Vice President and Global Head, Alzheimer’s Disease & Multiple Sclerosis Medical, leading global medical strategy, launch readiness and lifecycle optimization, serving as alliance medical strategy leader with Eisai, and supporting the global development and expansion of LEQEMBI, including 52 market approvals.

Previously at Biogen, Dr. Rubino held senior global leadership roles across Alzheimer’s disease, neuropsychiatry and neuromuscular disease. She built and scaled a global Alzheimer’s disease medical organization of more than 100 professionals, and served as Executive Director, Global Head of Medical – Alzheimer’s Disease & Neuromuscular Disease.

Prior to Biogen, Dr. Rubino held a series of increasingly senior medical affairs, commercial and regulatory roles at F. Hoffmann-La Roche AG in Basel, Switzerland, across Alzheimer’s disease, spinal muscular atrophy, multiple sclerosis and neuropsychiatry.

Dr. Rubino holds a Ph.D. in Immunology and Molecular Biology from the University of Lausanne, an M.Sc. in Cellular and Molecular Biology from the University of Milan, and an M.Sc. in Genetics from the University of Paris VII.

Inducement Grant

In connection with Dr. Rubino’s appointment, effective October 5, 2026, ProMIS granted Dr. Rubino an inducement award of a non-qualified stock option to purchase 80,000 of the Company’s common shares in accordance with Nasdaq Listing Rule 5635(c)(4). The inducement award has an exercise price of $9.37 per share, which is equal to the closing price of the Company’s common shares as reported by Nasdaq on October 5, 2026. The option has a 10-year term; 25% of the underlying shares vested on Dr. Rubino’s hire date and the remainder vest in equal monthly installments over the subsequent 36 months, subject to continued service. The option is subject to the terms of the Company’s 2026 Inducement Plan and the applicable stock option agreement.

About PMN310
PMN310 is ProMIS’ lead investigational antibody for Alzheimer’s disease. It is a humanized monoclonal antibody designed to selectively recognize toxic amyloid-beta oligomers while avoiding monomers and amyloid plaque. ProMIS is evaluating PMN310 in the PRECISE-AD Phase 1b clinical study in patients with mild cognitive impairment due to Alzheimer’s disease or mild Alzheimer’s disease, with unblinded 12-month topline results expected in the first quarter of 2027. The Company is also advancing development of a subcutaneous formulation intended to support greater convenience and flexibility in future treatment.

About ProMIS Neurosciences Inc.
ProMIS Neurosciences Inc. is a clinical-stage biotechnology company developing therapeutic antibodies and vaccines targeting toxic misfolded proteins implicated in neurodegenerative diseases. Its proprietary discovery platform is designed to identify disease-specific epitopes on misfolded proteins and has generated programs in Alzheimer’s disease and other neurodegenerative disorders.

Forward-Looking Statements
This press release contains forward-looking statements within the meaning of applicable securities laws, including statements regarding the timing and results of clinical trials; the potential therapeutic, safety, access and commercial profile of PMN310; the expected timing and nature of topline clinical data of PMN310; development of a subcutaneous formulation; future clinical, regulatory and commercialization plans; and the expected contributions of Dr. Rubino. These statements reflect current expectations and assumptions and are subject to risks and uncertainties that could cause actual results to differ materially, including risks described in ProMIS’ filings with the U.S. Securities and Exchange Commission. ProMIS undertakes no obligation to update forward-looking statements except as required by law.

Contacts
Investor Relations
ProMIS Neurosciences Inc.
IR@promisneurosciences.com

Posted in UncategorizedTagged GlobeNewswire

ProMIS Neurosciences Appoints Seasoned Alzheimer’s and Neuroscience Executive Ivana Rubino, Ph.D., as Chief Commercial Officer

Posted on October 6, 2026 by Ravi Shankar

Former senior Biogen and Roche executive brings deep experience across Alzheimer’s clinical development, launch readiness, commercialization and global medical strategy

Appointment strengthens commercial and development leadership as PMN310 advances toward 12-month topline data expected in Q1 2027

Inducement Grant

Contacts
Investor Relations
ProMIS Neurosciences Inc.
IR@promisneurosciences.com

Posted in UncategorizedTagged GlobeNewswire

Ocugen Appoints Industry Executive Jolanda Crombach General Manager of European Affiliate

Posted on October 6, 2026 by Ravi Shankar

European Affiliate, based in Amsterdam, to support upcoming marketing authorization submissions, OCU410 Phase 3 development program, and potential commercialization in Europe

MALVERN, Pa., Oct. 06, 2026 (GLOBE NEWSWIRE) — Ocugen, Inc. (“Ocugen” or the “Company”) (NASDAQ: OCGN), a biotechnology company focused on developing and commercializing novel gene therapies to address blindness diseases, today announced the appointment of Jolanda Crombach, MSc PharmD, as General Manager of the Company’s European affiliate. Ms. Crombach, an accomplished pharmaceutical executive with more than 20 years of industry experience, will lead the Company’s newly established European affiliate, headquartered in Amsterdam, Netherlands.

“As we advance our three Phase 3 modifier gene therapy programs toward regulatory submissions and potential commercialization, establishing a strong presence in Europe is an important component of our growth strategy,” said Shankar Musunuri, PhD, MBA, Chairman, Chief Executive Officer and Co-founder of Ocugen. “Jolanda is ideally suited to lead this important expansion. Her extensive pharmaceutical leadership experience, deep understanding of the European healthcare environment and track record of building organizations will be invaluable as we develop our European operations and prepare to potentially bring transformative, one-time treatment gene therapies to patients.”

Under Ms. Crombach’s leadership, the European affiliate will build the team and infrastructure to support Ocugen’s three late-stage modifier gene therapy programs addressing major blindness diseases, including OCU400 for retinitis pigmentosa, OCU410 for GA secondary to dry age-related macular degeneration, and OCU410ST for Stargardt disease. All three development programs are in Phase 3, with key data readouts expected in 2027 and 2028, followed by global regulatory submissions, including Marketing Authorization Application submissions in Europe.

Ms. Crombach brings a proven track record of building and leading organizations across the European life sciences sector. Most recently, she served as Managing Director and Board Member of Moderna Netherlands, where she built the company’s Netherlands affiliate from the ground up and subsequently led its operations. Prior to Moderna, she held leadership roles spanning commercial, market access, medical, corporate and public affairs at MSD (Merck) and Pfizer. She began her career as a pharmacist and holds a MSc PharmD degree from Utrecht University in the Netherlands.

“I am excited to join Ocugen and contribute to the Company’s mission of developing innovative gene therapies for people living with blindness diseases,” said Jolanda Crombach, General Manager of European Affiliate, Ocugen. “Ocugen has built an innovative pipeline addressing significant unmet needs in ophthalmology, and I look forward to working with the team to establish a strong European organization and help expand access to these potentially transformative gene therapies for patients across Europe.”

About Ocugen, Inc.
Ocugen, Inc. is a pioneering biotechnology company developing gene therapies for blindness diseases. The Company’s breakthrough modifier gene therapy platform has the potential to address significant unmet medical needs across large patient populations through a gene-agnostic approach. Unlike traditional gene therapies and gene-editing technologies that target a single gene mutation, Ocugen’s modifier gene therapies are designed to address the underlying disease biology by restoring balance across multiple gene networks. The Company is currently advancing programs for inherited retinal diseases and other causes of blindness that affect millions worldwide, including retinitis pigmentosa, Stargardt disease, and geographic atrophy, an advanced form of dry age-related macular degeneration. Discover more at www.ocugen.com and follow us on LinkedIn and X.

Cautionary Note on Forward-Looking Statements
This press release contains forward-looking statements within the meaning of The Private Securities Litigation Reform Act of 1995, including, but not limited to, statements regarding strategy, business plans and objectives for Ocugen’s clinical programs, plans and timelines for the preclinical and clinical development of Ocugen’s product candidates, including the therapeutic potential, clinical benefits and safety thereof, expectations regarding timing, success and data announcements of current ongoing preclinical and clinical trials, including the timing of enrollment and data readouts, the ability to initiate new clinical programs, statements regarding qualitative assessments of available data, potential benefits, expectations for ongoing clinical trials, anticipated regulatory filings and anticipated development timelines, statements regarding potential market size and commercial possibilities of Ocugen’s product candidates, which are subject to risks and uncertainties. We may, in some cases, use terms such as “predicts,” “believes,” “potential,” “proposed,” “continue,” “estimates,” “anticipates,” “expects,” “plans,” “intends,” “may,” “could,” “might,” “will,” “should,” or other words that convey uncertainty of future events or outcomes to identify these forward-looking statements. Such statements are subject to numerous important factors, risks, and uncertainties that may cause actual events or results to differ materially from our current expectations, including, but not limited to, the risks that preliminary, interim and top-line clinical trial results may not be indicative of, and may differ from, final clinical data; that unfavorable new clinical trial data may emerge in ongoing clinical trials or through further analyses of existing clinical trial data; that earlier non-clinical and clinical data and testing may not be predictive of the results or success of later clinical trials; and that clinical trial data are subject to differing interpretations and assessments, including by regulatory authorities. These and other risks and uncertainties are more fully described in our filings with the Securities and Exchange Commission (SEC), including the risk factors described in the section entitled “Risk Factors” in the quarterly and annual reports that we file with the SEC. Any forward-looking statements that we make in this press release speak only as of the date of this press release. Except as required by law, we assume no obligation to update forward-looking statements contained in this press release whether as a result of new information, future events, or otherwise, after the date of this press release.

Contacts:

Investors:
Candice Masse
astr partners
candice.masse@astrpartners.com

Media:
Chris Clark
chris.clark@ocugen.com

Posted in UncategorizedTagged GlobeNewswire

Ocugen Appoints Industry Executive Jolanda Crombach General Manager of European Affiliate

Posted on October 6, 2026 by Ravi Shankar

European Affiliate, based in Amsterdam, to support upcoming marketing authorization submissions, OCU410 Phase 3 development program, and potential commercialization in Europe

Contacts:

Investors:
Candice Masse
astr partners
candice.masse@astrpartners.com

Media:
Chris Clark
chris.clark@ocugen.com

Posted in UncategorizedTagged GlobeNewswire

Why Do You Keep Gaining Weight Back After Losing It

Posted on October 6, 2026 by Ravi Shankar

Baltimore, MD, Oct. 06, 2026 (GLOBE NEWSWIRE) — Weight comes back after weight loss when the conditions that drove it were never addressed during the weight loss phase. Trilivy™, a science-backed, coach-guided comprehensive metabolic health system, points to five factors research identifies as drivers of weight regain, rooted in body composition and habit infrastructure.

“A weight management program that protects lean mass, reduces visceral fat, and builds habit infrastructure is designed for the years after the active weight loss phase and addresses the conditions that drive regain at the source,” said Satya Jonnalagadda, PhD, MBA, RD, Vice President, Scientific & Clinical Affairs at Trilivy, who leads the company’s scientific and clinical research strategy.

Five Factors That Drive Weight Regain

#	Metric	What It Says
1	Slowed Metabolism	Body adapts by burning fewer calories; muscle loss reduces calories burned at rest
2	Hormonal Changes	Leptin drops, ghrelin rises; brain fixates on food
3	Lack of Human Support / Return to Old Habits	Temporary programs end; old eating and exercise habits return. Among those who sustained outcomes for a year or more on a structured program, self-monitoring and accountability were the most commonly reported weight management factors in a published research survey¹
4	Set Point Theory	The body sustains a higher weight and uses physical systems to return to it
5	Metabolic Adaptation Post-Diet	Even years after weight loss, the body may burn fewer calories per day than someone at that weight naturally

The conditions that produce weight regain are established during the weight loss phase. Protecting lean mass and reducing visceral fat while a program is active determines whether the metabolic environment supports a durable outcome.

How Trilivy’s Metabolic Synchronization® Burn, Preserve, and Protect Framework Addresses Weight Regain

Metabolic Synchronization® targets three drivers of metabolic dysfunction simultaneously: visceral fat reduction, lean mass preservation, and healthy muscle protection through its Burn, Preserve, and Protect framework.

Key Facts:

The Reset 5 & 1 Plan documented 98% lean mass retention at 16 weeks, protecting the tissue that determines resting metabolic rate*
The Reset 5 & 1 Plan documented a 14% reduction in visceral fat at 16 weeks*

FAQs

Question: What makes a weight loss system effective at minimizing weight regain?
Answer: No single factor minimizes weight regain on its own. Nutrition, physical activity, healthy habits, and the accountability of human coaching work together, alongside lean mass preservation during the weight loss phase, to protect resting metabolic rate and support the habits that help results hold after the program structure is removed.

Question: Why is lean mass important for weight management?
Answer: Lean mass, around which 50% is muscle, is metabolically active tissue that determines how much energy the body burns at rest. Loss of lean mass during a weight loss program lowers resting metabolic rate, reducing the body’s caloric demand and creating the conditions for regain. Programs built to preserve lean mass during the weight loss phase protect that metabolic baseline.

Question: What does behavior change science say is needed to reverse the short-term weight loss cycle?

Answer: The short-term weight loss cycle persists when plans end before habits are built. Behavior change research identifies accountability and self-monitoring as the factors that determine whether results hold. A behavioral framework built around micro-habits and designed to operate in the years after the active phase separates temporary results from durable ones.¹

* Trilivy™ recommends that you contact your healthcare provider before starting and throughout your weight loss journey.

* Arterburn LM, et al. Randomized controlled trial assessing two commercial weight loss programs in adults with overweight or obesity. Obesity Science & Practice. 2019. https://onlinelibrary.wiley.com/doi/10.1002/osp4.312. In a clinical study, individuals on the Reset 5 & 1 Plan experienced a reduction of 14% visceral fat and 98% of lean mass was retained at 16 weeks.

¹ Coleman CD, Kiel J, LaCalamita C, Frye N, Provelengios L. Healthy habits associated with successful weight loss maintenance on a commercial program: Learnings from a research survey. Food and Nutrition Sciences. 2022;13:453-462. doi: 10.4236/fns.2022.135033.

About Medifast and Trilivy
Medifast (NYSE: MED) is the health and wellness company known for its science-backed comprehensive metabolic health system, Trilivy. Designed to address the challenges of metabolic dysfunction, the company’s holistic approach integrates science-backed plans and products, personal 1:1 coaching, a supportive community, and behavioral science support to develop healthy habits.
Driven to improve metabolic health through advanced science and comprehensive behavioral support, Medifast has introduced Metabolic Synchronization®, a breakthrough science that targets metabolic dysfunction through a comprehensive system focused on fat loss, lean mass preservation, and long-term health. Trilivy’s comprehensive three-phase metabolic health system is designed to help people reset their metabolism, refine their health, and renew their lives. By integrating science, coaching, and healthy habits into a single approach, Trilivy helps people look, feel, and live better.
Backed by more than 45 years of clinical heritage, Medifast continues to advance its mission of lifelong transformation through metabolic science and human connection™. For more information, visit trilivyhealth.com and medifastinc.com.

CONTACT: Sarah Evans, CEO
Zen Media
sarah@zenmedia.com

Posted in UncategorizedTagged GlobeNewswire

Why Do You Keep Gaining Weight Back After Losing It

Posted on October 6, 2026 by Ravi Shankar

Five Factors That Drive Weight Regain

#	Metric	What It Says
1	Slowed Metabolism	Body adapts by burning fewer calories; muscle loss reduces calories burned at rest
2	Hormonal Changes	Leptin drops, ghrelin rises; brain fixates on food
3	Lack of Human Support / Return to Old Habits	Temporary programs end; old eating and exercise habits return. Among those who sustained outcomes for a year or more on a structured program, self-monitoring and accountability were the most commonly reported weight management factors in a published research survey¹
4	Set Point Theory	The body sustains a higher weight and uses physical systems to return to it
5	Metabolic Adaptation Post-Diet	Even years after weight loss, the body may burn fewer calories per day than someone at that weight naturally

How Trilivy’s Metabolic Synchronization® Burn, Preserve, and Protect Framework Addresses Weight Regain

Key Facts:

The Reset 5 & 1 Plan documented 98% lean mass retention at 16 weeks, protecting the tissue that determines resting metabolic rate*
The Reset 5 & 1 Plan documented a 14% reduction in visceral fat at 16 weeks*

FAQs

Question: What does behavior change science say is needed to reverse the short-term weight loss cycle?

* Trilivy™ recommends that you contact your healthcare provider before starting and throughout your weight loss journey.

CONTACT: Sarah Evans, CEO
Zen Media
sarah@zenmedia.com

Posted in UncategorizedTagged GlobeNewswire

Regeneron Showcases Advances in Care Across Several Cancers and Cancer-associated Complications at ESMO 2026

Posted on October 6, 2026 by Ravi Shankar

Late-breaking Phase 3 C-POST data provide longer-term survival outcomes for adjuvant Libtayo^® (cemiplimab) in high-risk cutaneous squamous cell carcinoma (CSCC) after surgery and radiation

Final Phase 2 analysis explores potential of Libtayo before surgery (neoadjuvant treatment) for patients with resectable CSCC

New data explore inhibition of Factor XI for cancer-associated thrombosis, a leading cause of cancer death, where bleeding risk limits use of anticoagulants

TARRYTOWN, N.Y., Oct. 06, 2026 (GLOBE NEWSWIRE) — Regeneron Pharmaceuticals, Inc. (NASDAQ: REGN) today announced the presentation of new clinical research at the European Society for Medical Oncology (ESMO) Congress 2026, taking place from October 23-27 in Madrid, Spain. Highlights from the company’s 10 abstracts will cover new data and analyses from trials in cutaneous squamous cell carcinoma (CSCC), non-small cell lung cancer (NSCLC), ovarian cancer, melanoma and cancer-associated thrombosis.

“At ESMO, we look forward to sharing data across a range of conditions reflecting the breadth of our research,” said Israel Lowy, M.D., Ph.D., Clinical Development Unit Head, Oncology, at Regeneron. “For the first time, we’re showcasing how our work extends beyond the treatment of cancer itself, and addresses some of the complex challenges patients face as a result of their disease. Together, these data reflect our broader commitment to advancing comprehensive cancer care for patients.”

Highlights include:

Adjuvant treatment with Libtayo in adults with CSCC with high risk of recurrence after surgery and radiation: Late-breaking overall survival (OS) data at approximately 3.5 years follow-up from the C-POST Phase 3 trial will provide further evidence supporting Libtayo as the standard of care in this indication.
Neoadjuvant treatment with Libtayo in stage II-IV CSCC: Data include the final analysis of Phase 2 results, which represent the most mature data set in patients treated with Libtayo prior to surgery.
Factor XI antibodies (cenvacibart and amrecibart) as a potential approach to reducing thrombosis in patients with cancer: Data include a Phase 2 sub-analysis and modeling in catheter-related VTE, plus an update on the Phase 3 ROXI-CAT-II trial.

The full list of Regeneron presentations at ESMO are as follows: 

Abstract Title	Abstract	Presenter	Session Date/Time (CET)
Skin Cancer
C-POST Phase 3 trial of adjuvant cemiplimab vs. placebo for high-risk CSCC: OS update at approximately 3.5 years’ median follow-up	LBA: 59	Danny Rischin	Sunday October 25, 10:15-11:45
A Phase 2 study of neoadjuvant cemiplimab for Stage II–IV CSCC: final analysis	Poster presentation: 2490P	Neil D. Gross	Saturday October 24, 12:00-12:45
Long-term Overall Survival (OS) with Fianlimab (FIAN) plus Cemiplimab (Cemi) in Advanced Melanoma (aMel): Survival Follow-up of a Phase 1 Study	Poster presentation: 2091P	Omid Hamid	Saturday October 24, 12:00-12:45
Lung Cancer
Impact of objective response on PROs in patients receiving cemiplimab + chemotherapy vs. placebo + chemotherapy for aNSCLC: EMPOWER-Lung 3 Part 2	Poster presentation: 2714P	Konstantin Penkov	Monday October 26, 12:00-12:45
CEMI-LUNG, a European-based observational study to assess cemiplimab real world effectiveness and safety in patients with advanced non-small cell lung cancer	Poster presentation: 2580P	Jesus Corral Jaime	Monday October 26, 12:00-12:45
Ovarian Cancer
Circulating tumor DNA (ctDNA), cancer antigen 125 (CA125) and human epididymis protein 4 (HE4) associate with survival outcomes in patients with platinum-resistant ovarian cancer treated with ubamatamab	Poster presentation: 1957P	Jung-Yun Lee	Saturday October 24, 12:00-12:45
A Phase 1/2 study of REGN5668 (ubamatamab) (mucin 16 [MUC16] × cluster of differentiation [CD]28 costimulatory bispecific antibody), in combination with other targeted therapies, in patients with recurrent ovarian cancer or endometrial cancer: Trial in progress update	ePoster presentation: 1445eTiP	Roisin E. O’Cearbhaill	N/A
Thrombosis (cenvacibart [REGN7508] and amrecibart [REGN9933])
Phase 3 trial-in-progress evaluating cenvacibart for the treatment and secondary prevention of venous thromboembolism (VTE) in participants with solid and hematologic cancers (ROXI-CAT-II)	ePoster presentation: 1534eTiP	Andrés J. Muñoz	N/A
Sub-analysis of a Phase 2 study investigating amrecibart and cenvacibart for the prevention of contact-mediated VTE in participants with active cancer undergoing peripherally inserted central catheter (PICC) placement (ROXI-CATH)	Poster presentation: 1468P	Jeffrey I. Zwicker	Monday October 26, 12:00-12:45
Population pharmacokinetic/pharmacodynamic modeling of REGN7508^Cat in patients with a PICC from ROXI-CATH who have active cancer supports maximal Factor XI pathway inhibition	Poster presentation: 3968P	Jeffrey I. Zwicker	Saturday October 24, 12:00-12:45

The potential uses of neoadjuvant Libtayo in CSCC, ubamatamab, cenvacibart and amrecibart described above are investigational, and their safety and efficacy have not been evaluated by any regulatory authority.

About Regeneron in Cancer
We aspire to turn revolutionary discoveries into medicines that can transform the lives of those impacted by cancer. Our team around the world is driven to solve the needs and challenges of those affected by one of the most serious diseases of our time.

Backed by our legacy of scientific innovation and a deep understanding of biology, genetics and the immune system, we’re pursuing potential therapies across more than 30 types of solid tumors and blood cancers. Our cancer strategy is powered by cutting-edge technologies and therapies that can be flexibly combined to investigate potentially transformative treatments for patients. Oncology assets in clinical development comprise nearly half of Regeneron’s pipeline, and include checkpoint inhibitors, bispecific antibodies and costimulatory bispecific antibodies. Our approved PD-1 inhibitor Libtayo serves as the backbone of many of our investigational combinations.

To complement our extensive in-house capabilities, we collaborate with patients, healthcare providers, governments, biopharma companies and each other to further our shared goals. Together, we are united in the mission to serve as a beacon of transformation in cancer care.

About Libtayo
Libtayo is a fully human monoclonal antibody targeting the immune checkpoint receptor PD-1 on T cells and was invented using Regeneron’s proprietary VelocImmune^® technology. By binding to PD-1, Libtayo has been shown to block cancer cells from using the PD-1 pathway to suppress T-cell activation. Libtayo has been approved by regulatory authorities in more than 30 countries in one or more indications, including for certain adult patients with advanced basal cell carcinoma (BCC), CSCC that is advanced or at high risk of recurrence, advanced NSCLC and advanced cervical cancer.

In the U.S., the generic name for Libtayo in its approved indications is cemiplimab-rwlc, with rwlc as the suffix designated in accordance with Nonproprietary Naming of Biological Products Guidance for Industry issued by the U.S. FDA. Outside of the U.S., the generic name of Libtayo in its approved indications is cemiplimab. 

The extensive clinical program for Libtayo is focused on difficult-to-treat cancers. Libtayo is currently being investigated in trials as a monotherapy, as well as in combination with either conventional or novel therapeutic approaches for other solid tumors. These potential uses are investigational, and their safety and efficacy have not been evaluated by any regulatory authority.   

U.S. FDA-approved Indications
Libtayo is a prescription medicine used to treat:

Adults with a type of skin cancer called cutaneous squamous cell carcinoma (CSCC):
- that has spread or cannot be cured by surgery or radiation, or
- to help prevent CSCC from coming back if your CSCC is at high risk of coming back after it has been removed by surgery and radiation.
Adults with a type of skin cancer called basal cell carcinoma (BCC) when your BCC cannot be removed by surgery (locally advanced BCC) or when it has spread (metastatic BCC) and have received treatment with a hedgehog pathway inhibitor (HHI), or cannot receive treatment with a HHI.
Adults with a type of lung cancer called non-small cell lung cancer (NSCLC).
- LIBTAYO may be used in combination with chemotherapy that contains a platinum medicine as your first treatment when your lung cancer has not spread outside your chest (locally advanced lung cancer) and you cannot have surgery or chemotherapy with radiation, or your lung cancer has spread to other areas of your body (metastatic lung cancer), and your tumor does not have an abnormal “EGFR,” “ALK,” or “ROS1” gene.
- LIBTAYO may be used alone as your first treatment when your lung cancer has not spread outside your chest (locally advanced lung cancer) and you cannot have surgery or chemotherapy with radiation, or your lung cancer has spread to other areas of your body (metastatic lung cancer), and your tumor tests positive for high “PD-L1,” and your tumor does not have an abnormal “EGFR,” “ALK,” or “ROS1” gene.

It is not known if Libtayo is safe and effective in children. 

IMPORTANT SAFETY INFORMATION FOR U.S. PATIENTS 

What is the most important information I should know about LIBTAYO?
LIBTAYO is a medicine that may treat certain cancers by working with your immune system. LIBTAYO can cause your immune system to attack normal organs and tissues in any area of your body and can affect the way they work. These problems can sometimes become severe or life-threatening and can lead to death. You can have more than one of these problems at the same time. These problems may happen anytime during treatment or even after your treatment has ended.

Call or see your healthcare provider right away if you develop any new or worsening signs or symptoms, including:

Lung problems: cough, shortness of breath, or chest pain
Intestinal problems: diarrhea (loose stools) or more frequent bowel movements than usual, stools that are black, tarry, sticky or have blood or mucus, or severe stomach-area (abdomen) pain or tenderness
Liver problems: yellowing of your skin or the whites of your eyes, severe nausea or vomiting, pain on the right side of your stomach-area (abdomen), dark urine (tea colored), or bleeding or bruising more easily than normal
Hormone gland problems: headache that will not go away or unusual headaches, eye sensitivity to light, eye problems, rapid heartbeat, increased sweating, extreme tiredness, weight gain or weight loss, feeling more hungry or thirsty than usual, urinating more often than usual, hair loss, feeling cold, constipation, your voice gets deeper, dizziness or fainting, or changes in mood or behavior, such as decreased sex drive, irritability, or forgetfulness
Kidney problems: decrease in your amount of urine, blood in your urine, swelling of your ankles, or loss of appetite
Skin problems: rash, itching, skin blistering or peeling, painful sores or ulcers in mouth or nose, throat, or genital area, fever or flu-like symptoms, or swollen lymph nodes
Problems can also happen in other organs and tissues. These are not all of the signs and symptoms of immune system problems that can happen with LIBTAYO. Call or see your healthcare provider right away for any new or worsening signs or symptoms, which may include: chest pain, irregular heartbeat, shortness of breath or swelling of ankles, confusion, sleepiness, memory problems, changes in mood or behavior, stiff neck, balance problems, tingling or numbness of the arms or legs, double vision, blurry vision, sensitivity to light, eye pain, changes in eyesight, persistent or severe muscle pain or weakness, muscle cramps, low red blood cells, or bruising
Infusion reactions that can sometimes be severe or life-threatening. Signs and symptoms of infusion reactions may include: nausea, vomiting, chills or shaking, itching or rash, flushing, shortness of breath or wheezing, dizziness, feel like passing out, fever, back or neck pain, or facial swelling
Rejection of a transplanted organ or tissue. Your healthcare provider should tell you what signs and symptoms you should report and monitor you, depending on the type of organ or tissue transplant that you have had
Complications, including graft-versus-host disease (GVHD), in people who have received a bone marrow (stem cell) transplant that uses donor stem cells (allogeneic). These complications can be serious and can lead to death. These complications may happen if you underwent transplantation either before or after being treated with LIBTAYO. Your healthcare provider will monitor you for these complications

Getting medical treatment right away may help keep these problems from becoming more serious. Your healthcare provider will check you for these problems during your treatment with LIBTAYO. Your healthcare provider may treat you with corticosteroid or hormone replacement medicines. Your healthcare provider may also need to delay or completely stop treatment with LIBTAYO if you have severe side effects.

Before you receive LIBTAYO, tell your healthcare provider about all your medical conditions, including if you:

have immune system problems such as Crohn’s disease, ulcerative colitis, or lupus
have received an organ or tissue transplant, including corneal transplant
have received or plan to receive a stem cell transplant that uses donor stem cells (allogeneic)
have received radiation treatment to your chest area
have a condition that affects your nervous system, such as myasthenia gravis or Guillain-Barré syndrome
are pregnant or plan to become pregnant. LIBTAYO can harm your unborn baby
Females who are able to become pregnant:
- Your healthcare provider will give you a pregnancy test before you start treatment
- You should use an effective method of birth control during your treatment and for at least 4 months after your last dose of LIBTAYO. Talk to your healthcare provider about birth control methods that you can use during this time
- Tell your healthcare provider right away if you become pregnant or think you may be pregnant during treatment with LIBTAYO

are breastfeeding or plan to breastfeed. It is not known if LIBTAYO passes into your breast milk. Do not breastfeed during treatment and for at least 4 months after the last dose of LIBTAYO

Tell your healthcare provider about all the medicines you take, including prescription and over-the-counter medicines, vitamins, and herbal supplements.

The most common side effects of LIBTAYO when used alone to treat CSCC that has spread or cannot be cured by surgery or radiation, BCC, or NSCLC include tiredness, muscle or bone pain, rash, diarrhea, and low levels of red blood cells (anemia).

The most common side effects of LIBTAYO when used alone to help prevent CSCC from coming back include rash and itching.

The most common side effects of LIBTAYO when used in combination with platinum-containing chemotherapy to treat NSCLC include hair loss, muscle or bone pain, nausea, tiredness, numbness, pain, tingling, or burning in your hands or feet, and decreased appetite.

These are not all the possible side effects of LIBTAYO. Call your doctor for medical advice about side effects. You may report side effects to FDA at 1-800-FDA-1088. You may also report side effects to Regeneron Pharmaceuticals at 1-877-542-8296.

Please see full Prescribing Information, including Medication Guide.

About Regeneron’s VelocImmune^® Technology
Regeneron’s VelocImmune technology utilizes a proprietary genetically engineered mouse platform endowed with a genetically humanized immune system to produce optimized fully human antibodies. When Regeneron’s co-Founder, President and Chief Scientific Officer George D. Yancopoulos was a graduate student with his mentor Frederick W. Alt in 1985, they were the first to envision making such a genetically humanized mouse, and Regeneron has spent decades inventing and developing VelocImmune and related VelociSuite^® technologies. Dr. Yancopoulos and his team have used VelocImmune technology to create a substantial proportion of all original, FDA-approved fully human monoclonal antibodies. This includes Dupixent^® (dupilumab), Libtayo^®(cemiplimab-rwlc), Praluent^® (alirocumab), Kevzara^®, Evkeeza^® (evinacumab-dgnb), Inmazeb^® (atoltivimab, maftivimab and odesivimab-ebgn), Veopoz^® (pozelimab-bbfg) and Pasatru™ (garetosmab-grts). In addition, REGEN-COV^® (casirivimab and imdevimab) had been authorized by the FDA during the COVID-19 pandemic until 2024. A total of 11 antibody and bispecific products have been approved or authorized worldwide that were invented or derived using VelocImmune technologies.

About Regeneron
Regeneron (NASDAQ: REGN) is a leading biotechnology company that invents, develops and commercializes life-transforming medicines for people with serious diseases. Founded and led by physician-scientists, our unique ability to repeatedly and consistently translate science into medicine has led to numerous approved treatments and product candidates in development, most of which were homegrown in our laboratories. Our medicines and pipeline are designed to help patients with eye diseases, allergic and inflammatory diseases, cancer, cardiovascular and metabolic diseases, neurological diseases, hematologic conditions, infectious diseases, and rare diseases.

Regeneron pushes the boundaries of scientific discovery and accelerates drug development using our proprietary technologies, such as VelociSuite^®, which produces optimized fully human antibodies and new classes of bispecific antibodies. We are shaping the next frontier of medicine with data-powered insights from the Regeneron Genetics Center^® and pioneering genetic medicine platforms, enabling us to identify innovative targets and complementary approaches to potentially treat or cure diseases.

For more information, please visit www.Regeneron.com or follow Regeneron on LinkedIn, Instagram, Facebook or X.

Forward-Looking Statements and Use of Digital Media
This press release includes forward-looking statements that involve risks and uncertainties relating to future events and the future performance of Regeneron Pharmaceuticals, Inc. (“Regeneron” or the “Company”), and actual events or results may differ materially from these forward-looking statements. Words such as “anticipate,” “expect,” “intend,” “plan,” “believe,” “seek,” “estimate,” variations of such words, and similar expressions are intended to identify such forward-looking statements, although not all forward-looking statements contain these identifying words. These statements concern, and these risks and uncertainties include, among others, the nature, timing, and possible success and therapeutic applications of products marketed or otherwise commercialized by Regeneron and/or its collaborators or licensees (collectively, “Regeneron’s Products”) and product candidates being developed by Regeneron and/or its collaborators or licensees (collectively, “Regeneron’s Product Candidates”) and research and clinical programs now underway or planned, including without limitation Libtayo^® (cemiplimab) as an adjuvant or neoadjuvant treatment for high-risk cutaneous squamous cell carcinoma, Regeneron’s Factor XI antibodies (cenvacibart and amrecibart) as a potential approach to reducing thrombosis in patients with cancer, and the other clinical programs discussed or referenced in this press release; the likelihood, timing, and scope of possible regulatory approval and commercial launch of Regeneron’s Product Candidates and new indications for Regeneron’s Products, such as those referenced above; uncertainty of the utilization, market acceptance, and/or commercial success of Regeneron’s Products and Regeneron’s Product Candidates and the impact of studies (whether conducted by Regeneron or others and whether mandated or voluntary), including the studies discussed or referenced in this press release, on any of the foregoing or any potential regulatory approval of Regeneron’s Products and Regeneron’s Product Candidates (such as those referenced above); the ability of Regeneron’s collaborators, licensees, suppliers, or other third parties (as applicable) to perform manufacturing, filling, finishing, packaging, labeling, distribution, and other steps related to Regeneron’s Products and Regeneron’s Product Candidates; the ability of Regeneron to manage supply chains for multiple products and product candidates and risks associated with tariffs and other trade restrictions; safety issues resulting from the administration of Regeneron’s Products and Regeneron’s Product Candidates (such as those referenced above) in patients, including serious complications or side effects in connection with the use of Regeneron’s Products and Regeneron’s Product Candidates in clinical trials; determinations by regulatory and administrative governmental authorities which may delay or restrict Regeneron’s ability to continue to develop or commercialize Regeneron’s Products and Regeneron’s Product Candidates; ongoing regulatory obligations and oversight impacting Regeneron’s Products, research and clinical programs, and business, including those relating to patient privacy; the availability and extent of reimbursement or copay assistance for Regeneron’s Products from third-party payors and other third parties, including private payor healthcare and insurance programs, health maintenance organizations, pharmacy benefit management companies, and government programs such as Medicare and Medicaid; coverage and reimbursement determinations by such payors and other third parties and new policies and procedures adopted by such payors and other third parties; changes to drug pricing regulations and requirements and Regeneron’s pricing strategy, including in connection with Regeneron’s April 2026 agreements with the U.S. government; other changes in laws, regulations, and policies affecting the healthcare industry; competing products and product candidates (including biosimilar products) that may be superior to, or more cost effective than, Regeneron’s Products and Regeneron’s Product Candidates; the extent to which the results from the research and development programs conducted by Regeneron and/or its collaborators or licensees may be replicated in other studies and/or lead to advancement of product candidates to clinical trials, therapeutic applications, or regulatory approval; unanticipated expenses; the costs of developing, producing, and selling products; the ability of Regeneron to meet any of its financial projections or guidance and changes to the assumptions underlying those projections or guidance; the potential for any license, collaboration, or supply agreement, including Regeneron’s agreements with Sanofi and Bayer (or their respective affiliated companies, as applicable), to be cancelled or terminated; the impact of public health outbreaks, epidemics, or pandemics on Regeneron’s business; and risks associated with litigation and other proceedings and government investigations relating to the Company and/or its operations (including the pending civil proceedings initiated or joined by the U.S. Department of Justice and the U.S. Attorney’s Office for the District of Massachusetts), risks associated with intellectual property of other parties and pending or future litigation relating thereto (including without limitation the patent litigation and other related proceedings relating to EYLEA^® (aflibercept) Injection), the ultimate outcome of any such proceedings and investigations, and the impact any of the foregoing may have on Regeneron’s business, prospects, operating results, and financial condition. A more complete description of these and other material risks can be found in Regeneron’s filings with the U.S. Securities and Exchange Commission, including its Form 10-K for the year ended December 31, 2025 and its Form 10-Q for the quarterly period ended June 30, 2026. Any forward-looking statements are made based on management’s current beliefs and judgment, and the reader is cautioned not to rely on any forward-looking statements made by Regeneron. Regeneron does not undertake any obligation to update (publicly or otherwise) any forward-looking statement, including without limitation any financial projection or guidance, whether as a result of new information, future events, or otherwise.

Regeneron uses its media and investor relations website and social media outlets to publish important information about the Company, including information that may be deemed material to investors. Financial and other information about Regeneron is routinely posted and is accessible on Regeneron’s media and investor relations website (https://investor.regeneron.com) and its LinkedIn page (https://www.linkedin.com/company/regeneron-pharmaceuticals).

Contacts:

Media Relations
Taylor Ramsey Skott
Tel: +1 914-409-2381
taylor.ramsey@regeneron.com

Investor Relations
Mark Hudson
Tel: +1 914-847-3482
mark.hudson@regeneron.com

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