Author: Ravi Shankar

• Brepocitinib 45 mg once-daily achieved statistically significant benefit compared to placebo on the primary and all key secondary endpoints for each of CLARITY-1 and CLARITY-2, the two identical Phase 3 trials comprising the CLARITY program in NIU
• Median time to treatment failure for brepocitinib patients was greater than 48 weeks in both studies, compared with ~12 weeks on placebo in each study (p<0.0001 in both studies), including 40 weeks of steroid-free treatment, setting a new bar for time to failure and steroid-sparing benefit in NIU
• Pooled across the CLARITY studies, 62% of patients on brepocitinib achieved steroid-free quiescence at Week 48, compared with 20% on placebo (p<0.0001), with similar results in each study
• Of patients that entered the CLARITY studies (pooled) with macular edema, 42% of eyes on brepocitinib achieved resolution of macular edema at Week 48, compared with 4.8% on placebo (p<0.0001), with similar results in each study
• The magnitude and breadth of benefit observed across every ranked endpoint, compared with results reported in registrational trials of existing NIU therapies, suggest brepocitinib has the potential to be the most effective systemic, non-steroid treatment option for NIU
• Safety data consistent with prior brepocitinib clinical trials; no new safety signals or findings
• Priovant intends to file a supplemental New Drug Application (sNDA) for brepocitinib for the treatment of NIU in the first half of calendar year 2027
• Roivant will host an investor call to discuss these updates today, October 21, 2026, at 8:00 a.m. ET

BASEL, Switzerland and LONDON and NEW YORK and DURHAM, N.C., Oct. 21, 2026 (GLOBE NEWSWIRE) — Roivant (Nasdaq:ROIV) and Priovant Therapeutics today announced positive results from the Phase 3 CLARITY program evaluating brepocitinib in non-infectious uveitis (NIU). Brepocitinib met the primary endpoint for both the CLARITY-1 and CLARITY-2 studies. Brepocitinib also achieved statistically significant and clinically meaningful benefit on all key secondary endpoints, including measurements of sustained steroid-free quiescence at Week 48, chorioretinal vascular leakage, resolution of macular edema and patient-reported visual functioning. These results were achieved despite a substantially more aggressive steroid taper than precedent NIU trials.

“Today marks a potential turning point for the field of uveitis and for the patients and physicians who have waited nearly a decade for a new systemic, non-steroid treatment option. The phenomenal results from the Phase 3 CLARITY program suggest that brepocitinib could meaningfully change how we treat non-infectious uveitis across multiple etiologies,” said Quan Dong Nguyen, MD, MSc, FAAO, FARVO, FASRS, Professor of Ophthalmology, Professor of Medicine (Immunology/Rheumatology), and Professor of Pediatrics (Rheumatology) at the Byers Eye Institute and Stanford University School of Medicine, President of the International Ocular Inflammation Society (IOIS), and Executive Vice President of the Foster Ocular Immunology Society (FOIS). “Even with a much faster taper of oral prednisone, patients treated with brepocitinib in CLARITY demonstrated highly differentiated benefits across the primary and all key secondary endpoints, including quiescence, resolution of macular edema and improvement in chorioretinal inflammation. This is the kind of outcome that can redefine expectations for an entire field. To see this breadth of benefit across disease control, macular edema and visual functioning is tremendously exciting for those of us who care for these patients.”

NIU, a debilitating ocular inflammation, is one of the leading causes of blindness among the working age population. Undertreated NIU can result in permanent vision loss. NIU is frequently associated with ocular pain, floaters and visual impairment across multiple domains (acuity, peripheral vision, color recognition, ability to focus on moving objects, night vision, etc.) that can interfere with everyday activities including reading the newspaper, driving, socializing, working and independent self-care. NIU is estimated to affect 70,000 to 190,000 adults in the United States.

CLARITY Study Design and Data

The CLARITY program enrolled 371 patients across two identical studies, CLARITY-1 and CLARITY-2. Patients were randomized 1:1 to once-daily brepocitinib 45 mg or placebo for a 48-week double-masked treatment period. All patients received an 8-week oral corticosteroid (OCS) regimen of 60 mg/day for 2 weeks followed by a mandatory 6-week steroid taper to zero. The primary endpoint was time to treatment failure, assessed from Week 6 through Week 48.

Time to treatment failure in CLARITY-1 and CLARITY-2 (Kaplan-Meier estimates, brepocitinib vs. placebo) is captured below:

Brepocitinib demonstrated consistent benefits on preventing treatment failure across key subgroups, including intermediate, posterior, and panuveitis; patients with and without prior TNFi experience; and multiple etiologies of uveitis, including idiopathic disease, birdshot chorioretinopathy, and sarcoidosis.

Pre-specified multiplicity controlled secondary endpoints in the CLARITY trials included sustained steroid-free quiescence, improvement in chorioretinal vascular leakage as assessed through wide-field fluorescein angiography (FA), resolution of macular edema, and improvement in patient-reported visual functioning (NEI VFQ-25 overall composite score).

Results on the primary and key secondary endpoints are captured below:

	CLARITY-1 (N=166)					CLARITY-2 (N=204)
	Brepocitinib 45 mg		Placebo		Delta*	Brepocitinib 45 mg		Placebo		Delta*
Hazard Ratio for Treatment Failure vs. Placebo (95% CI)	0.27 (0.17–0.43)		—		P<0.0001	0.22 (0.14–0.34)		—		P<0.0001
Cumulative Incidence of Treatment Failure at Week 48	35.4%		78.7%		Δ 43.3%; P<0.0001	32.4%		77.8%		Δ 45.4%; P<0.0001
Steroid-Free Quiescence in Both Eyes at Week 48	58.8%		19.8%		Δ 38.1%; P<0.0001	64.4%		19.4%		Δ 45.2%; P<0.0001
Achievement of FA Response (≥ 30% Reduction from Baseline) at Week 48 Among Eyes With FA Score > 5 at Baseline	39.4%		8.6%		Δ 31.3%; P<0.0001	54.9%		7.2%		Δ 49.8%; P<0.0001
Resolution of Macular Edema at Week 48 Among Eyes with Macular Edema at Baseline	40.4%		2.1%		Δ 33.3%; P=0.0041	42.6%		7.0%		Δ 40.1%; P=0.0002
Achievement of ≥ 5-point Improvement in NEI VFQ-25 Overall Composite Score from Baseline at Week 48, Among Subjects with Baseline ≤ 95	36.4%		13.7%		Δ 21.9%; P=0.0013	40.4%		14.1%		Δ 24.5%; P=0.0003

*Deltas account for covariates
Efficacy analyses exclude one subject who was randomized but did not receive any doses of masked study drug.

Safety and Regulatory Submissions

Brepocitinib was generally well tolerated during the treatment period. Most events were mild or moderate in severity, and only 3% of participants discontinued treatment due to an AE. The observed safety profile in the trials was consistent with the known safety profile of brepocitinib, with no new safety signals observed.

Priovant intends to file a supplemental New Drug Application (sNDA) for brepocitinib for treatment of NIU in the first half of calendar year 2027.

“The breadth and magnitude of benefit seen in the CLARITY studies position brepocitinib to potentially set a new standard for the treatment of non-infectious uveitis,” said Ben Zimmer, CEO of Priovant. “With LISRAYA now commercially available for adults with dermatomyositis, we see NIU as the potential next pillar of a leading rare disease immunology franchise. I would like to thank all of the investigators and patients who participated in the CLARITY trials, without whom this moment would not be possible.”

Investor Conference Call Information

Roivant will host a live conference call and webcast at 8:00 a.m. ET on Wednesday, October 21, 2026, to discuss the Phase 3 results for brepocitinib in non-infectious uveitis. To access the conference call by phone, please register online using this registration link. The presentation and webcast details will also be available under “Events & Presentations” in the Investors section of the Roivant website at https://investor.roivant.com/news-events/events. The archived webcast will be available on Roivant’s website after the conference call.

Roivant will also host an investor day on Wednesday, December 9, 2026. To attend the event in person or by webcast, please register online using this registration link. 

About Priovant

Priovant Therapeutics is a biotechnology company dedicated to developing and commercializing novel therapies for autoimmune diseases with high morbidity and few available treatment options. The company’s commercial product, LISRAYA™ (brepocitinib) is the first and only targeted oral therapy approved for the treatment of adults with dermatomyositis. See important LISRAYA safety information, including boxed warning, at lisrayahcp.com/pi. Brepocitinib, a first-in-class TYK2/JAK1 inhibitor, also recently generated positive Phase 3 data in non-infectious uveitis (NIU). Brepocitinib is under evaluation in a Phase 3 program in cutaneous sarcoidosis, and a Phase 2b/3 program in lichen planopilaris. These potential indications have not been approved by the FDA. Priovant Therapeutics is a Roivant (Nasdaq: ROIV) company.

About Roivant

Roivant (Nasdaq: ROIV) is a commercial-stage biopharmaceutical company that aims to improve the lives of patients by accelerating the development and commercialization of medicines that matter. Roivant’s pipeline includes LISRAYA™ (brepocitinib), a potent small molecule inhibitor of JAK1 and TYK2 FDA-approved for the treatment of dermatomyositis in adult patients and also in late-stage development for the treatment of non-infectious uveitis, cutaneous sarcoidosis and lichen planopilaris; IMVT-1402, a fully human monoclonal antibody targeting FcRn in development across several IgG-mediated autoimmune indications; and mosliciguat, an inhaled sGC activator in development for pulmonary hypertension associated with interstitial lung disease. We advance our pipeline by creating nimble subsidiaries or “Vants” to develop and commercialize our medicines and technologies. For more information, visit www.roivant.com.

Roivant Forward-Looking Statements

This press release contains forward-looking statements. Statements in this press release may include statements that are not historical facts and are considered forward-looking within the meaning of Section 27A of the Securities Act of 1933, as amended (the “Securities Act”), and Section 21E of the Securities Exchange Act of 1934, as amended (the “Exchange Act”), which are usually identified by the use of words such as “anticipate,” “believe,” “continue,” “could,” “estimate,” “expect,” “intends,” “may,” “might,” “plan,” “possible,” “potential,” “predict,” “project,” “should,” “would” and variations of such words or similar expressions. The words may identify forward-looking statements, but the absence of these words does not mean that a statement is not forward-looking. We intend these forward-looking statements to be covered by the safe harbor provisions for forward-looking statements contained in Section 27A of the Securities Act and Section 21E of the Exchange Act.

Our forward-looking statements include, but are not limited to, statements regarding our or our management team’s expectations, hopes, beliefs, intentions or strategies regarding the future, and statements that are not historical facts, including statements about the clinical and therapeutic potential of our product and product candidates, the availability and success of topline results from our ongoing clinical trials, the timing of potential regulatory approvals for our product and product candidates, any commercial potential of our product and product candidates following applicable regulatory approvals and the outcome of any pending litigation. In addition, any statements that refer to projections, forecasts or other characterizations of future events, results or circumstances, including any underlying assumptions, are forward-looking statements. Actual results may differ materially from those contemplated in these statements due to a variety of risks, uncertainties and other factors.

Although we believe that our plans, intentions, expectations and strategies as reflected in or suggested by those forward-looking statements are reasonable, we can give no assurance that the plans, intentions, expectations or strategies will be attained or achieved. Furthermore, actual results may differ materially from those described in the forward-looking statements and will be affected by a number of risks, uncertainties and assumptions, including, but not limited to, those risks set forth in the Risk Factors section of our filings with the U.S. Securities and Exchange Commission. Moreover, we operate in a very competitive and rapidly changing environment in which new risks emerge from time to time. These forward-looking statements are based upon the current expectations and beliefs of our management as of the date of this press release, and are subject to certain risks and uncertainties that could cause actual results to differ materially from those described in the forward-looking statements. Except as required by applicable law, we assume no obligation to update publicly any forward-looking statements, whether as a result of new information, future events or otherwise.

Contacts:
Investors
Keyur Parekh
keyur.parekh@roivant.com

Media
Stephanie Lee
stephanie.lee@roivant.com

A photo accompanying this announcement is available at https://www.globenewswire.com/NewsRoom/AttachmentNg/76d0a0eb-19e9-4a8e-ad9a-3d963f8a2082

DURHAM, N.C., Oct. 21, 2026 (GLOBE NEWSWIRE) — Immunovant, Inc. (Nasdaq: IMVT) today announced that it will report its financial results for the second fiscal quarter ended September 30, 2026 on Monday, November 9, 2026 before the market opens. Roivant Sciences Ltd. (Nasdaq: ROIV), Immunovant’s majority stockholder, will host a live conference call and webcast at 8:00 a.m. ET that same day, which will include a business update for Immunovant.

To access the Roivant conference call by phone, please register online using this registration link. The presentation and webcast details will also be available under “News & Events” in the Investors section of the Immunovant website at https://www.immunovant.com/investors/news-events/ir-calendar. The archived webcast will be available on Immunovant’s website after the conference call.

About Immunovant 

Immunovant, Inc. is a clinical-stage immunology company dedicated to enabling normal lives for people with autoimmune diseases and is a majority-owned subsidiary of Roivant. As a trailblazer in anti-FcRn technology, the Company is developing innovative, targeted therapies to meet the complex and variable needs of people with autoimmune diseases. For additional information on the Company, please visit immunovant.com. 

Contacts: 

Investors
Keyur Parekh
keyur.parekh@roivant.com

Media
Stephanie Lee
stephanie.lee@roivant.com

NEW YORK, Oct. 21, 2026 (GLOBE NEWSWIRE) — Kaltura (Nasdaq: KLTR), the Agentic Digital Experience company, today announced it will release its third quarter financial results for the period ended September 30, 2026, after market close on Monday, November 9, 2026.

Management will host a conference call to review the Company’s third quarter 2026 financial results and discuss the financial outlook.

Date:	Monday, November 9, 2026
Time:	4:30 p.m. ET
United States/Canada Toll Free:	+1-877-407-0789
International Toll:	+1-201-689-8562

A live and archived webcast will be available in the Investor Relations section of Kaltura’s website at: https://investors.kaltura.com/news-and-events/events

About Kaltura
Kaltura’s mission is to power rich, agentic digital experiences across organizational journeys for customers, employees, learners, and audiences. Its platform combines intelligent content creation, enterprise-grade content management and intelligence, and multimodal conversational engagement capabilities. Kaltura serves leading enterprises, financial institutions, educational institutions, media and telecom providers, and other organizations worldwide. For more information, visit www.kaltura.com.

Investor Contacts:
Kaltura, Inc.
Liron Sharon
Interim Principal Financial Officer
IR@Kaltura.com

Sapphire Investor Relations, LLC
Erica Mannion and Michael Funari
IR@Kaltura.com
+1-617-542-6180

Media Contacts:
Kaltura, Inc.
Nohar Zmora
pr.team@kaltura.com

—Expands BioCryst portfolio of targeted oral prophylactic therapy options to meet patients’ individual needs and preferences— 

—ORLADEYO is the first and only targeted oral prophylactic therapy with options for HAE patients aged 2 and above—

RESEARCH TRIANGLE PARK, N.C., Oct. 21, 2026 (GLOBE NEWSWIRE) — BioCryst Pharmaceuticals, Inc. (Nasdaq: BCRX) today announced the U.S. Food and Drug Administration (FDA) has approved its supplemental New Drug Application (sNDA) for use of the oral pellet formulation of once-daily ORLADEYO^® (berotralstat) for prophylactic therapy in adults and adolescents aged 12 years and older. The new 150 mg ORLADEYO pellet formulation provides an alternative administration option for adults and adolescents who may have difficulty swallowing, prefer not to take a capsule or choose to remain on a pellet formulation beyond age 12. 

With this approval, prescribers can now provide their adult and adolescent patients with the option to take once-daily, orally administered ORLADEYO for prophylaxis to prevent attacks of HAE in either capsule or pellet formulation. The ORLADEYO pellet formulation is sprinkle-like in appearance and size and can be poured directly into the mouth and swallowed immediately with water or milk, or sprinkled over a spoonful of soft, non-acidic food.

“We are focused on advancing HAE attack prevention through a portfolio of therapies designed to support the diverse needs and preferences of patients,” said Charlie Gayer, President and Chief Executive Officer of BioCryst. “The approval of ORLADEYO pellets for adults and adolescents strengthens our ability to provide personalized treatment choice by offering the proven efficacy of ORLADEYO in a new formulation to make administration easier for patients who have difficulty swallowing or prefer not to take a capsule. This milestone reflects our commitment to optimizing the management of HAE with proven therapies that help address the evolving needs of patients across the treatment landscape.”

ORLADEYO is the first and only targeted oral prophylactic therapy for patients with HAE aged 2 and above. A capsule formulation of ORLADEYO received FDA approval for prophylaxis to prevent HAE attacks in adult and pediatric patients 12 years and older in December 2020 and is now approved in more than 45 countries around the world. In December 2025, the oral pellet formulation of ORLADEYO was approved by FDA for prophylactic therapy in pediatric patients in the U.S. with HAE aged 2 to <12 years.

Across two clinical studies, ORLADEYO capsules (150 mg) resulted in sustained attack prevention in patients 12 years and older with a mean attack-rate reduction of 91% at 96 weeks and an 88% reduction in rescue medication use ¹​. ORLADEYO was safe and well tolerated in both trials. The most frequently reported adverse reactions in patients receiving ORLADEYO compared with placebo were gastrointestinal reactions and back pain. These gastrointestinal reactions generally occurred early after initiation of treatment with ORLADEYO, became less frequent with time, and typically self-resolved.

The FDA approval was based on chemistry, manufacturing, and controls information and data demonstrating the safety and tolerability of the ORLADEYO pellet formulation compared to ORLADEYO capsules.

BioCryst is committed to providing support every step of the way and offers Empower Patient Services, a single stop for all patient and HCP ORLADEYO needs. It combines a specialty pharmacy and patient support program with a dedicated team of experts who provide individualized and streamlined support navigating the insurance process, affordability, adherence, and related needs.

To download multimedia: https://www.globenewswire.com/NewsRoom/AttachmentNg/91e297e1-8672-4a7b-aa7a-ad4bfe93ea47

Visit www.ORLADEYO.com for more information. 

About ORLADEYO^® (berotralstat)
ORLADEYO^® (berotralstat) is the first and only oral therapy designed specifically to prevent attacks of hereditary angioedema (HAE) in adult and pediatric patients 2 years and older. One dose of ORLADEYO per day works to prevent HAE attacks by decreasing the activity of plasma kallikrein.

U.S. Indication and Important Safety Information

INDICATION
ORLADEYO® (berotralstat) is a plasma kallikrein inhibitor indicated for prophylaxis to prevent attacks of hereditary angioedema (HAE) in adults and pediatric patients 2 years and older.

Limitations of use
The safety and effectiveness of ORLADEYO for the treatment of acute HAE attacks have not been established. ORLADEYO should not be used for the treatment of acute HAE attacks. Additional doses or doses of ORLADEYO higher than the prescribed once-daily dose are not recommended due to the potential for QTc interval prolongation.

IMPORTANT SAFETY INFORMATION
An increase in QTc interval was observed in adults at dosages higher than 150 mg once daily and was concentration dependent.

The most common adverse reactions (≥10%) in patients receiving ORLADEYO were abdominal pain, vomiting, diarrhea, back pain and gastroesophageal reflux disease.

In adult and pediatric patients aged 12 years and older with moderate or severe hepatic impairment (Child-Pugh B or C), the recommended dosage of ORLADEYO capsules is 110 mg once daily with food. In pediatric patients aged 2 to <12 years with moderate or severe hepatic impairment (Child-Pugh B or C), avoid use of ORLADEYO.

Berotralstat is a substrate of P-glycoprotein (P-gp) and breast cancer resistance protein. P-gp inducers may decrease berotralstat plasma concentration, leading to reduced efficacy of ORLADEYO. Avoid concomitant use of P-gp inducers with ORLADEYO.

ORLADEYO at a dose of 150 mg is a moderate inhibitor of CYP2D6 and CYP3A4. Concomitant use of ORLADEYO with CYP2D6 or CYP3A4 substrates can increase exposure of the CYP2D6 or CYP3A4 substrates and may increase the risk of adverse reactions associated with the substrates. If ORLADEYO is concomitantly used with CYP2D6 or CYP3A4 substrates where minimal increases in the concentration of the substrates may lead to serious adverse reactions, closely monitor or modify the dosage of the CYP2D6 or CYP3A4 substrate.

The safety and effectiveness of ORLADEYO in pediatric patients <2 years of age have not been established.

There are insufficient data available to inform drug-related risks with ORLADEYO use in pregnancy. There are no data on the presence of berotralstat in human milk, its effects on the breastfed infant, or its effects on milk production.

To report SUSPECTED ADVERSE REACTIONS, contact BioCryst Pharmaceuticals, Inc. at 1-833-633-2279 or FDA at 1-800-FDA-1088 or www.fda.gov/medwatch.

About BioCryst Pharmaceuticals
BioCryst is a global biotechnology company focused on developing and commercializing medicines for hereditary angioedema (“HAE”) and other rare diseases, driven by its deep commitment to improving the lives of people living with these conditions. BioCryst has commercialized ORLADEYO® (berotralstat), the first oral, once-daily plasma kallikrein inhibitor and is advancing a pipeline of potential first-in-class or best-in-class therapeutics for rare diseases. For more information, please visit www.biocryst.com or follow us on LinkedIn.

Forward-Looking Statements
This press release contains forward-looking statements, including statements regarding BioCryst’s expectations relating to the oral pellet formulation of ORLADEYO for patients with HAE. These statements involve known and unknown risks, uncertainties and other factors which may cause BioCryst’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. These statements reflect our current views with respect to future events and are based on assumptions and are subject to risks and uncertainties. Given these uncertainties, you should not place undue reliance on these forward-looking statements. Some of the factors that could affect the forward-looking statements contained herein include: BioCryst’s ability to successfully implement its commercialization plans for ORLADEYO, including the once-daily oral pellet formulation; the commercial viability of ORLADEYO oral pellets, including their ability to achieve market acceptance; risks related to government actions, including that decisions and other actions related to pricing and reimbursement may not be taken when expected or at all, or that the outcomes of such decisions and other actions may not be in line with BioCryst’s current expectations; and the FDA may withdraw market approval for ORLADEYO. This list is not exclusive. To see a more comprehensive list of risks, please refer to the documents BioCryst files periodically with the Securities and Exchange Commission, specifically BioCryst’s most recent Annual Report on Form 10-K, Quarterly Reports on Form 10-Q and Current Reports on Form 8-K, which identify important factors that could cause actual results to differ materially from those contained in BioCryst’s forward-looking statements.

Contact:

Investors:
investorrelations@biocryst.com

Media:
media@biocryst.com

¹ Kiani-Alikhan S, Gower R, Craig T, et al. Once-daily oral berotralstat for long-term prophylaxis of hereditary angioedema: the open-label extension of the APeX-2 randomized trial. J Allergy Clin Immunol Pract. 2024;12(3):733-743.e10.

Luxembourg, 21 October 2026, 13:00 CET

With reference to Article 19(3) of Regulation (EU) No 596/2014 of the European Parliament and of the Council of 16 April 2014 on market abuse (Market Abuse Regulation), ArcelorMittal announces a notification of share transactions by Lumen Investments S.à r.l., an entity forming part of the Significant Shareholder structure, is available in the Luxembourg Stock Exchange’s electronic database OAM on www.bourse.lu and on ArcelorMittal’s website www.arcelormittal.com under Investors > Share Transactions by Management: https://corporate.arcelormittal.com/investors/corporate-governance/share-transactions-by-management.

ENDS

About ArcelorMittal

ArcelorMittal is one of the world’s leading integrated steel and mining companies with a presence in 60 countries and primary steelmaking operations in 14 countries. It is the largest steel producer in Europe, among the largest in the Americas, and has a growing presence in Asia through its joint venture AM/NS India. ArcelorMittal sells its products to a diverse range of customers including the automotive, engineering, construction and machinery industries, and in 2025 generated revenues of $61.4 billion, produced 55.6 million metric tonnes of crude steel and 48.8 million tonnes of iron ore. Our purpose is to produce smarter steels for people and planet. Steels made using innovative processes which use less energy, emit significantly less carbon and reduce costs. Steels that are cleaner, stronger and reusable. Steels for the renewable energy infrastructure that will support societies as they transform through this century. With steel at our core, our inventive people and an entrepreneurial culture at heart, we will support the world in making that change.
 

ArcelorMittal is listed on the stock exchanges of New York (MT), Amsterdam (MT), Paris (MT), Luxembourg (MT) and on the Spanish stock exchanges of Barcelona, Bilbao, Madrid and Valencia (MTS). http://corporate.arcelormittal.com/

ArcelorMittal Investor Relations contact information
General	+44 20 7543 1128
Retail	+44 20 3214 2893
Bonds/Credit	+33 157 955 035

ArcelorMittal Corporate Communications contact information
Paul Weigh
Tel:	+44 20 3214 2419
E-mail	press@arcelormittal.com

A seasoned global people leader and organizational strategist, Ms. Aspesi will help scale Entrada’s people and organization for its next phase of growth

BOSTON, Oct. 21, 2026 (GLOBE NEWSWIRE) — Entrada Therapeutics, Inc. (Nasdaq: TRDA) today announced the appointment of Linea Aspesi as Chief People Officer.

“Linea has a proven track record of scaling organizations and developing high-performing teams from discovery through commercial stages,” said Dipal Doshi, Chief Executive Officer at Entrada Therapeutics. “We are in a catalyst-rich period with our neuromuscular programs, and Linea brings deep experience that will be invaluable as we continue to build an industry-leading culture that enables Entradans to do their best work and deliver on the potential of our pipeline. People are the foundation of any organization, and at Entrada, we know that a strong and engaged team is critical to our ability to develop a new class of genetic medicines and ultimately bring them to the patients who need them most.”

“Entrada is a company with a clear and steady commitment to patients and to one another,” said Ms. Aspesi. “I’m thrilled to join the team at such an important time in Entrada’s growth and look forward to building on its strong, mission-driven culture and fostering an environment where our colleagues can continue to do their best work as we grow and advance our pipeline for patients.”

Ms. Aspesi is an organizational leader with more than twenty years of experience driving culture transformation at biopharmaceutical and technology companies ranging from small-cap to Fortune 500. With a focus on scaling organizations from discovery through commercial stages, she has led companies through critical inflection points while executing culture strategies that put people first and drive employee engagement and retention. Prior to Entrada, Ms. Aspesi served as Chief People Officer at KalVista Pharmaceuticals (acquired by Chiesi Group) and held multiple executive-level human resources leadership roles at life science companies including Editas Medicine, Forma Therapeutics, Inc. (acquired by Novo Nordisk), Saniona, Inc., Sobi, Inc., and Genzyme Biologics Manufacturing (acquired by Sanofi). Ms. Aspesi holds a BA in Education from the University of Massachusetts, Amherst.

About Entrada Therapeutics
Entrada Therapeutics is a clinical-stage biopharmaceutical company aiming to transform the lives of patients by establishing a new class of genetic medicines that engage intracellular targets that have long been considered inaccessible. Through proprietary, versatile and modular approaches, Entrada is advancing a robust development portfolio of genetic medicines for the potential treatment of neuromuscular and inherited retinal diseases, among others. The Company’s lead oligonucleotide programs are in development for the potential treatment of people living with Duchenne muscular dystrophy who are exon 44, 45, 50 and 51 skipping amenable. Entrada has partnered to develop a clinical-stage program, VX-670, for myotonic dystrophy type 1.

For more information about Entrada, please visit our website, www.entradatx.com, and follow us on LinkedIn.

Forward-Looking Statements
This press release contains express and implied forward-looking statements that involve substantial risks and uncertainties. All statements, other than statements of historical facts, contained in this press release, including statements regarding Entrada’s strategy, future operations, prospects and plans, objectives of management, the validation and differentiation of Entrada’s approach and EEV platform and its ability to advance its programs and provide a potential treatment for patients, constitute forward-looking statements within the meaning of The Private Securities Litigation Reform Act of 1995. The words “anticipate,” “believe,” “continue,” “could,” “estimate,” “expect,” “intend,” “may,” “might,” “objective,” “ongoing,” “plan,” “predict,” “project,” “potential,” “should,” or “would,” or the negative of these terms, or other comparable terminology are intended to identify forward-looking statements, although not all forward-looking statements contain these identifying words. Entrada may not actually achieve the plans, intentions or expectations disclosed in these forward-looking statements, and you should not place undue reliance on these forward-looking statements. Actual results or events could differ materially from the plans, intentions and expectations disclosed in these forward-looking statements as a result of various important factors, including the risks and uncertainties identified in Entrada’s filings with the Securities and Exchange Commission (SEC), including the Company’s most recent Form 10-K and in subsequent filings Entrada may make with the SEC. In addition, the forward-looking statements included in this press release represent Entrada’s views as of the date of this press release. Entrada anticipates that subsequent events and developments will cause its views to change. However, while Entrada may elect to update these forward-looking statements at some point in the future, it specifically disclaims any obligation to do so. These forward-looking statements should not be relied upon as representing Entrada’s views as of any date subsequent to the date of this press release.

Media Contact
Megan Prock McGrath
CTD Comms, LLC
megan@ctdcomms.com

Investor Contact
Doug Snow
Head of Investor Relations
dsnow@entradatx.com

Patient Advocacy Contact
Sarah Friedhoff
Head of Patient Advocacy
patientadvocacy@entradatx.com

A photo accompanying this announcement is available at https://www.globenewswire.com/NewsRoom/AttachmentNg/e3ca0d9c-6117-4c74-9bc2-21f28c13c1ea

WuXi AppTec outlines five peptide manufacturing trends for 2026 as oral dosing raises API demand and moves scale-up pressure into purification and supply.

San Diego, CA, Oct. 21, 2026 (GLOBE NEWSWIRE) — Oral peptide dosing can require 10 to 100 times the dose, and therefore the active pharmaceutical ingredient (API), when oral bioavailability falls below 1%, according to a 2026 review in Frontiers in Drug Delivery.¹ The shift is shaping peptide manufacturing trends in 2026, moving scale-up pressure past synthesis and into route design, building-block supply, purification and drug product. In one published WuXi TIDES peptide program, the team raised overall route yield from less than 0.1% to 3%. It delivered Good Laboratory Practice (GLP) and Good Manufacturing Practice (GMP) API in 10 months.

1. Oral Peptide Dosing Can Multiply the API a Program Must Make

In practical terms, a peptide dosed at 1 mg per day by injection would need approximately 100 mg per day orally at 1% bioavailability. The same review in Frontiers in Drug Delivery notes that manufacturing costs for synthetic peptides scale approximately linearly with dose, so that increase carries into raw material needs, manufacturing capacity and quality control. It also describes oral semaglutide as a boundary case rather than proof that oral delivery suits most peptides.

Oral octreotide shows the multiplier in an approved product. According to the FDA label for Mycapssa, a single 20 mg oral dose of octreotide acetate produced systemic exposure similar to a 0.1 mg subcutaneous dose, a 200-fold difference in administered mass.² The comparison is specific to that product and study, but it shows how far oral delivery can raise the API a program has to make.

As a result, the API needed for an oral program cannot be estimated from the injectable dose. Eventual dose, patient population, route yield, purification recovery and drug product requirements have to be modeled together, early.

In a published case study, WuXi TIDES evaluated four synthesis routes and eight sets of conditions for a next-generation oral cyclic peptide, moving from a 50-g demonstration batch to a 1-kg demonstration batch and then a 6-kg GLP batch within six months. The case covers preclinical scale-up and does not establish clinical performance or commercial manufacturing readiness.

“Oral delivery changes how much API a peptide program has to make. A patient may absorb only a small share of each dose, yet every gram of API still has to be synthesized, purified and released to specification, so route efficiency and downstream capacity become early design choices,” said Yu Lu, Senior Vice President, WuXi TIDES, part of WuXi AppTec. 

2. Fragment Routes Raised One Long-Peptide Yield From Under 0.1% to 3%

The coupling efficiency and overall yield drop sharply when peptides longer than 50 amino acids are built by conventional solid-phase synthesis. Hybrid and convergent routes get around that limit: shorter fragments are prepared separately, then joined.

Published work on the kilogram-scale GMP manufacture of tirzepatide shows the approach at volume.³ Researchers developed a hybrid solid- and liquid-phase route with continuous processing, real-time analytical monitoring and nanofiltration for intermediate purification.

In a published WuXi TIDES program, a complex peptide conjugate needed an 87-step synthesis. The team rebuilt the original route as fragments under 50 amino acids, linked by chemical ligation. Overall yield rose from less than 0.1% to 3%. Separate teams could make fragments in parallel, which shortened the timeline. WuXi TIDES runs solid-phase, liquid-phase and hybrid synthesis, using both linear and convergent routes, on its peptide API process development platform.

3. Building-Block Supply Is Moving Onto the Critical Path

Unnatural amino acids, linkers and other modified components can determine both route design and timeline. When a required building block has limited commercial supply, teams have three options: qualify a new source, make it internally or redesign the route.

In the same conjugate program, three unnatural amino acid starting materials were in limited supply. WuXi TIDES developed synthetic processes for them and produced more than 3 kg in-house to support GLP and GMP production. That took an external supply dependency off the program’s critical path.

4. Purification Capacity Has to Match Synthesis Output

A faster route moves the bottleneck downstream if chromatography, filtration, isolation and analytical throughput do not scale with it. Purification often trades purity against recovery, since narrower chromatographic fractions improve purity but leave usable product in neighboring fractions. Research on synthetic glucagon showed that continuous multicolumn chromatography with internal recycling of product-containing fractions could ease that trade-off.⁴

In the conjugate program, the original column material was unstable under basic buffer conditions. WuXi TIDES screened alternatives and worked with the supplier on a custom alkali-resistant blend. The new column reduced impurities by 80% and increased final overall yield by 20%. WuXi TIDES also includes continuous chromatography in its peptide purification toolbox.

5. Drug Product Belongs in the Scale-Up Plan

Oral peptide programs rely on formulation approaches built around a molecule’s absorption, including permeation enhancers and specialized dosage forms. The Frontiers in Drug Delivery review concludes that oral success depends on molecular pharmacology rather than formulation technology. API volume, solid-state requirements, the formulation process and finished-dose capacity therefore need to be planned together. Integrated contract research, development and manufacturing organization (CRDMO) models offer one way to coordinate that planning. WuXi TIDES provides peptide API and drug product development and manufacturing, including spray drying, under one global quality system, from preclinical through commercial stages.

As oral peptide programs advance, the API required per patient will keep shaping peptide manufacturing decisions, from route selection through the finished dose.

Sources:
¹ Niazi, Sarfaraz K. “Oral Delivery of Peptides and Proteins: Pharmacokinetic Boundaries, Negative Selection, and Route Triage.” Frontiers in Drug Delivery, vol. 6, 2026, article 1776167, https://doi.org/10.3389/fddev.2026.1776167.

² Chiesi USA, Inc. “Mycapssa (Octreotide) Capsule, Delayed Release.” DailyMed, National Library of Medicine, 24 July 2025, dailymed.nlm.nih.gov/dailymed/drugInfo.cfm?setid=58d80bc6-bdfb-4908-93e7-aace447c8d1a. 

³ Frederick, Michael O., et al. “Kilogram-Scale GMP Manufacture of Tirzepatide Using a Hybrid SPPS/LPPS Approach with Continuous Manufacturing.” Organic Process Research & Development, vol. 25, no. 7, July 2021, pp. 1628–36, https://doi.org/10.1021/acs.oprd.1c00108.

⁴ Luca, Chiara De et al. “From batch to continuous chromatographic purification of a therapeutic peptide through multicolumn countercurrent solvent gradient purification.” Journal of chromatography. A vol. 1625 (2020): 461304. doi:10.1016/j.chroma.2020.461304

Frequently Asked Questions

Question: What are the biggest peptide manufacturing trends in 2026?

Answer: Five trends are shaping peptide manufacturing in 2026:

• Oral dosing that multiplies API demand
• Fragment-based routes for long peptides
• Building-block supply moving onto the critical path
• Purification capacity that must match synthesis output
• Drug product planned alongside API

At oral bioavailability below 1%, a program can need 10 to 100 times the dose. That pushes pressure through every step after synthesis. 

Question: How much more API does an oral peptide need than an injectable?

Answer: At 1% oral bioavailability, a peptide dosed at 1 mg per day by injection would need approximately 100 mg per day orally, according to a 2026 review in Frontiers in Drug Delivery. The review puts typical oral bioavailability for systemic peptides below 1% and notes that synthetic peptide manufacturing costs scale approximately linearly with dose. The actual multiplier depends on the molecule, formulation and pharmacokinetics.

Question: Why are hybrid or fragment-based routes used for long peptides?

Answer: Coupling efficiency and overall yield drop sharply when peptides longer than 50 amino acids are built by conventional solid-phase synthesis. Fragment routes make shorter pieces separately and join them. In one published WuXi TIDES program, an 87-step peptide conjugate was rebuilt from fragments under 50 amino acids linked by chemical ligation. Overall yield rose from less than 0.1% to 3%, and parallel fragment work shortened the timeline.

Question: When should peptide building-block supply be addressed?

Answer: Building-block supply should be addressed during lead optimization, before candidate selection is complete and before a scarce component becomes a critical-path dependency. Unnatural amino acids and linkers can have limited availability at development scale. In one published program, WuXi TIDES developed processes for three limited-supply unnatural amino acids and produced more than 3 kg in-house to support GLP and GMP production.

Question: Why does purification become the bottleneck as peptide production scales?

Answer: Higher synthesis output moves the constraint downstream if chromatography, filtration and isolation capacity do not grow at the same rate. Column chemistry matters as much as column size. In one published WuXi TIDES program, a custom alkali-resistant stationary phase reduced impurities by 80% and increased final overall yield by 20%. That program delivered GLP and GMP API in 10 months.

About WuXi AppTec

WuXi AppTec is a trusted partner and contributor to the pharmaceutical and life sciences industries, providing R&D and manufacturing services that help advance healthcare innovation. With operations across Asia, Europe, and North America, we offer integrated, end-to-end services through our unique CRDMO (Contract Research, Development, and Manufacturing Organization) platform. We are privileged to work alongside partners across 30+ countries, supporting their efforts to bring breakthrough treatments to patients. Guided by our vision that every drug can be made, and every disease can be treated, we are committed to advancing breakthroughs for patients—one collaboration at a time. Learn more at https://www.wuxiapptec.com.

CONTACT: Majed Soufi
Zen Media
PR@zenmedia.com

VANCOUVER, British Columbia, Oct. 21, 2026 (GLOBE NEWSWIRE) — Xali Gold Corp. (TSXV:XGC) (“Xali Gold” or the “Company”) is pleased to announce that it has completed its Ficha Técnica Ambiental (“FTA”) application for its resource confirmation and exploration drilling program at the Pico Machay Gold Project (“Pico Machay” or the “Project”) in Huancavelica, Peru.

The FTA application is expected to be submitted to Peru’s Ministry of Energy and Mines (“MINEM”) on October 21^st or 22^nd, as soon as the Company receives documentation from MINEM regarding the attendance of the successful informative workshop held on October 7^th, 2026, with members of the Comunidad Campesina de Salcca Santa Ana (“Santa Ana community”) and representatives of MINEM.

“Submitting the FTA will bring us another step closer to the drilling planned to support an updated mineral resource estimate and subsequent preliminary economic assessment (“PEA”) at Pico Machay,” said Joanne Freeze, President and CEO of Xali Gold. “The program is planned to verify historical drilling results and improve our understanding of the controls to gold mineralization, providing a stronger foundation for the resource update. The PEA will evaluate potential development options and project economics, helping us define the next steps for advancing Pico Machay.”

Xali Gold is planning an initial program of approximately 3,000 metres of diamond drilling, including approximately 2,000 metres to twin previous reverse circulation holes within the historical resource area. The FTA permit will allow up to 20,000 metres from 20 platforms, which will include further resource definition drilling as well as extensive exploration drilling. The proposed drilling locations are shown in Figure 1 below.

Experienced Team Supporting Pico Machay’s Development

Xali Gold has assembled an experienced multidisciplinary team to advance Pico Machay through resource estimation and economic assessment, while preparing for potential future development. Combining expertise in geology, mine engineering, metallurgy, environmental management, permitting and project finance, with extensive experience in Peru, the team provides a strong foundation for evaluating the Project’s development potential and planning the technical, permitting and financial steps required to advance it.

The Company’s previously announced technical and project finance team includes:

• Ing. Wilder Frank Garcia Haro – Exploration Manager: Xali Gold’s full-time Exploration Manager, Ing. Garcia brings more than 30 years of international exploration and mine development experience, including senior roles with Rio Alto, Tahoe Resources, Newmont, Barrick Gold, Gold Fields and Antamina. His experience at Peru’s La Arena and Shahuindo gold operations includes leading exploration programs that expanded resources and supported mine planning, bringing directly relevant expertise to the advancement of Pico Machay.
• David Thomas, P.Geo. – Mineral Resource Estimation: Principal Geologist with DKT Geosolutions, Mr. Thomas brings more than 30 years of geological experience, including resource estimation and evaluation of high-sulphidation epithermal gold deposits. His extensive South American experience includes mineral resource estimation at Cañariaco in Peru and resource estimate review at Gramalote in Colombia. He prepared the Company’s December 2025 technical report on Pico Machay and is part of the team advancing the updated mineral resource estimate.
• Gordon Zurowski, P.Eng. – Mine Engineering and Economic Evaluation: Principal Mine Engineer with AGP Mining Consultants, Mr. Zurowski has more than 30 years of experience in mine operations and consulting, specializing in open-pit planning and economic evaluation. His Peruvian project experience includes Cuajone, Cañariaco Norte, Cerro Lindo, Magistral and Marcona.
• Adam Johnston, FAusIMM, CP(Met) – Metallurgy and Processing: Chief Metallurgist with Transmin Metallurgical Consultants, Mr. Johnston has more than 30 years of international experience spanning metallurgical testing, process design, commissioning and operations. His experience includes Peruvian heap-leach and high-sulphidation gold projects, including Corihuarmi, Tres Cruces and Pucamarca.
• Aran Gough, R.P.Bio. – Environmental Management and Permitting: The Company’s Senior Advisor – ESG, Mr. Gough brings 29 years of international experience. His work in Peru includes guiding Zafranal through environmental assessment and regulatory approval, and overseeing permitting and environmental programs for Toromocho through construction and into operations.
• Brent Cochrane, M.A., ICD.D. – Project Finance: Mr. Cochrane brings more than 40 years of international mining finance experience, including serving as Vice President, Finance and Administration of Compañía Minera Antamina S.A. His financing experience in Peru includes both Antamina and Mina Justa.
• Susan Mitchell – Senior Financial Advisor: Ms. Mitchell brings more than 40 years of experience in mining finance and capital markets, with senior roles at CIBC, Cyprus AMAX Minerals and WestLB. She has extensive expertise in capital sourcing, transaction structuring, mergers and acquisitions, and financial risk management. Susan will support the Company’s financing strategy and evaluation of potential capital sources as Pico Machay advances through resource estimation, subsequent economic assessment and consideration of future development.

About Pico Machay

Located within the Southern Peru Epithermal Gold-Silver Belt, Pico Machay sits in a historically productive mining district in the Western Cordillera of the Andes (click here for location map). The Project benefits from existing infrastructure and a mining-friendly community eager to partner on sustainable development.

Xali Gold remains confident in the significant upside potential at Pico Machay, which hosts a historical resource and several untested exploration targets on the Project. Various historical engineering studies at Pico Machay were completed through 2009 and evaluated the potential for a low-cost, low strip-ratio, open-pit heap-leach operation. Given that those studies were based on a long-term gold price of $700/oz and several exploration targets remain untested, Xali Gold considers the upside potential to be very strong.

Figure 1: Proposed diamond drilling locations at Pico Machay

Grant of Incentive Stock Options

‍The Company also announces that on October 17, 2026, it has granted 1,600,000 incentive stock options (the “Options”) to eligible employees, consultants, and directors of the Company, in accordance with the Company’s Stock Option Plan. The Options are exercisable at $0.20 per share for a period of five years from the date of grant, with 20% vesting immediately and an additional 20% vesting each quarter thereafter until fully vested. The Options are subject to the policies of the TSX Venture Exchange.

About Xali Gold

Xali Gold is a gold and silver exploration company focused on advancing opportunities in the Americas. The Company is focused on the exploration and development of Pico Machay, an advanced exploration-stage gold project in Peru with a near-term production goal. 

The Company’s approach to community engagement and responsible development is guided by strong governance principles and Board oversight that support long-term stakeholder relationships.

Joanne C. Freeze, P.Geo. is a Qualified Person as defined by National Instrument 43-101 and has reviewed and approved the contents of this release.

Neither the TSX Venture Exchange nor its Regulation Services Provider accepts responsibility for the adequacy or accuracy of this release.

On behalf of the Board of Xali Gold Corp.

“Joanne Freeze” P.Geo.
President, CEO and Director

For further information please contact:
Joanne Freeze, President & CEO                                
Tel: + 1 (604) 512-3359                                                                 
info@xaligold.com                

Forward-looking Disclaimer
This press release contains forward-looking information within the meaning of Canadian securities laws (“forward-looking statements”). Forward-looking statements are typically identified by words such as: believe, expect, anticipate, intend, estimate, plans, postulate and similar expressions, or are those, which, by their nature, refer to future events. All statements that are not statements of historical fact are forward-looking statements.

Forward-looking statements in this press release include, without limitation, statements regarding: the anticipated timing of FTA approval, the scope and commencement of the planned drilling program, the preparation of an updated mineral resource estimate and preliminary economic assessment, and the expected contributions of the Company’s multidisciplinary team to the evaluation, advancement and potential development of Pico Machay.

These forward-looking statements are made as of the date of this press release. Although the Company believes the forward-looking statements in this press release are reasonable, it can give no assurance that the expectations and assumptions in such statements will prove to be correct. The Company cautions investors that any forward-looking statements by the Company are not guarantees of future results or performance, and are subject to risks, uncertainties, assumptions and other factors which could cause events or outcomes to differ materially from those expressed or implied by such forward-looking statements.

Known risk factors and assumptions include risks associated with exploration and project development; accessing further funding and related dilution: continuing its projected growth, or being fully able to implement its business strategies; the calculation of mineral resources and additional work required to convert historical resources to current mineral resources; the nature, quality and quantity of any mineral deposits that may be located on the project; operational risks associated with mining and mineral processing; fluctuations in metal prices and assumptions including costs; title matters; government regulation; obtaining and renewing necessary consents, authorizations, licenses and permits; environmental liability and insurance; reliance on key personnel; local community opposition; currency fluctuations; labour disputes; competition; variations in market conditions, and the volatility of our common share price and volume; future sales of shares by existing shareholders; and other risk factors described in Xali Gold’s MD&A and other filings with Canadian securities regulators, which may be viewed at www.sedarplus.ca. Although we have attempted to identify important factors that could cause actual actions, events or results to differ materially from those described in forward-looking statements, there may be other factors that cause actions, events or results not to be as anticipated, estimated or intended.

There can be no assurance that forward-looking statements will prove to be accurate, as actual results and future events could differ materially from those anticipated in such statements. Accordingly, readers should not place undue reliance on forward-looking statements. Xali Gold expressly disclaims any intention or obligation to update or revise any forward-looking information, whether as a result of new information, future events or otherwise, except in accordance with applicable securities laws.

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Ibogaine regulatory readiness pack completed and U.S. cGMP manufacturing agreement concluded with DEA-registered Benuvia in Texas; investment supports PsyLabs’ intended supply of pharmaceutical-grade ibogaine for the planned U.S. development program

NEW YORK, Oct. 21, 2026 (GLOBE NEWSWIRE) — Psyence Biomedical Ltd. (Nasdaq: PBM) (“Psyence BioMed” or the “Company”) today announced that both milestones attached to its backstop subscription commitment in Psyence Labs Ltd. (“PsyLabs”) have been achieved and that the Company, through its wholly-owned subsidiary Psyence Biomed II Corp., has completed its additional investment in PsyLabs of US$2,599,896. The milestones include the completion of an ibogaine regulatory readiness documentation package and the execution of a U.S. current Good Manufacturing Practice (“cGMP”) manufacturing agreement with Benuvia Operations, LLC (“Benuvia”), representing important progress in advancing the Company’s planned U.S. pharmaceutical-grade ibogaine development program.

As previously announced on September 23, 2026, Psyence BioMed agreed to invest up to US$5 million in PsyLabs, comprising an irrevocable commitment of US$2.4 million (936 PsyLabs ordinary shares at US$2,564 per share) under its pro rata pre-emption entitlement in PsyLabs’ current financing round and a backstop commitment of up to US$2.6 million to subscribe for shares in that financing round not taken up by other PsyLabs shareholders, payable in up to two tranches of up to US$1.3 million each upon the achievement of specified milestones. The backstop tranches were required to be called and completed by December 31, 2026.

Key Development Milestones Achieved

Regulatory Readiness Documentation

PsyLabs has completed its ibogaine regulatory readiness pack, a documentation package intended to support future regulatory interactions relating to pharmaceutical-grade ibogaine hydrochloride (HCl).

The completion of this documentation represents an important preparatory step in supporting the regulatory development activities contemplated under the Company’s U.S. ibogaine program.

U.S. cGMP Manufacturing Agreement

A manufacturing services agreement has been entered into with Benuvia by Texas Ibogaine Research Corporation (“TIRC”), the Company’s wholly-owned Texas subsidiary. Benuvia operates a controlled-substance manufacturing facility in Round Rock, Texas registered with the U.S. Drug Enforcement Administration (“DEA”).

As previously announced on October 5, 2026, the agreement is intended to support the planned U.S. manufacture of pharmaceutical-grade ibogaine active pharmaceutical ingredient (“API”) under cGMP standards, subject to applicable regulatory requirements.

The agreement establishes a U.S. manufacturing relationship intended to support future nonclinical and clinical development activities.

Advancing a Coordinated U.S. Ibogaine Development Strategy

In structuring the planned U.S. manufacturing program, the Company and PsyLabs agreed that the Benuvia agreement would be entered into by TIRC rather than by PsyLabs. TIRC was established to carry out the manufacturing, nonclinical and regulatory development work required before any human clinical trial could be proposed in the United States, and, as a U.S. developer, may be positioned to pursue domestic funding and grant opportunities that may be available for that work. This structure is intended to allow PsyLabs to remain focused on cultivating, extracting and supplying pharmaceutical-grade ibogaine HCl. Under the binding term sheet between TIRC and PsyLabs announced on September 28, 2026, PsyLabs is expected to serve as TIRC’s exclusive ibogaine supplier for the United States, subject to the conclusion of a definitive agreement, which the parties have agreed to conclude on or before November 30, 2026.

Additional Investment in PsyLabs Completed

Following certification by the PsyLabs board of directors that both development milestones had been achieved, PsyLabs called both backstop tranches ahead of the December 31, 2026, deadline.

Psyence Biomed II Corp. subscribed for 1,014 ordinary shares of PsyLabs at US$2,564 per share, reflecting the US$54 million pre-money equity valuation set for the financing round, for aggregate subscription proceeds of US$2,599,896. Immediately prior to the investment, the Company held approximately 41.13% of PsyLabs’ issued and outstanding shares. Following completion of the investment, and after giving effect to the previously announced share exchange which closed October 1, 2026, the Company holds approximately 43.37% of PsyLabs’ issued and outstanding shares. The investment was funded from the Company’s existing cash resources.

Management Commentary

“Achieving both milestones well ahead of the December 31 deadline is a clear signal that the ibogaine program is moving from planning into execution,” said Jody Aufrichtig, Chief Executive Officer of Psyence BioMed and TIRC. “PsyLabs now has the regulatory documentation and additional capital to support the supply of pharmaceutical-grade ibogaine, and TIRC has a U.S. cGMP manufacturing partner in place to support the development work we are planning. Each company is doing what it is best equipped to do, which we believe is the right structure for building long-term value for our shareholders.”

Related-Party Transaction

PsyLabs is a related party of the Company and a significant shareholder of Psyence BioMed. The investment, including the backstop commitment, was reviewed and approved by a special committee of the Company’s independent directors and by its audit committee, in accordance with the Company’s related-party transaction policies and applicable Nasdaq requirements.

ABOUT PSYENCE BIOMED

Psyence Biomedical Ltd. (Nasdaq: PBM) is a Nasdaq-listed company with its wholly-owned subsidiary, Texas Ibogaine Research Corporation, headquartered in Texas. It is one of the few multi-asset, vertically integrated biopharmaceutical companies specializing in neuroplastogen-based therapeutics and the manufacture of pharmaceutical-grade drug candidates. It is the first life sciences biotechnology company focused on developing nature-derived, non-synthetic psilocybin and ibogaine-based neuroplastogen medicine to be listed on Nasdaq. The Company is dedicated to addressing unmet mental health needs and is committed to an evidence-based approach to developing safe, effective and FDA-approved nature-derived neuroplastogen treatments across a range of mental health disorders.

ABOUT PSYLABS

PsyLabs is a neuroplastogen active pharmaceutical ingredient development company, federally licensed in its operating jurisdiction to cultivate, extract and export psilocybin mushrooms and other neuroplastogen compounds, including psilocybin, psilocin, mescaline, ibogaine and dimethyltryptamine, to lawful medical and research markets. PsyLabs operates from an ISO 22000 and GMP-compliant facility, with a focus on natural compound purification, regulatory support and global distribution. www.psylabs.life 

CONTACTS

Psyence Biomedical Ltd. ir@psyencebiomed.com media@psyencebiomed.com 
info@psyencebiomed.com · +1 416-477-1708

Investor contact: Michael Kydd, Investor Relations Advisor — michael@psyencebiomed.com 

FORWARD-LOOKING STATEMENTS

This communication contains “forward-looking statements” within the meaning of applicable securities laws, including the U.S. Private Securities Litigation Reform Act of 1995. These include statements regarding the investment by Psyence BioMed in PsyLabs, including the achievement and certification of the related milestones and the anticipated effects of the investment; the application of the proceeds of that investment; the resulting shareholding of Psyence BioMed in PsyLabs; the completion and effects of the previously announced share exchange; the manufacturing services agreement between TIRC and Benuvia, including the planned U.S. manufacture of pharmaceutical-grade ibogaine active pharmaceutical ingredient and the timing, scale and cost of such manufacture; the capitalization, funding and intended role of TIRC, including its ability to access U.S. funding and grant opportunities; the expected conclusion of a definitive license and supply agreement between TIRC and PsyLabs, including PsyLabs’ expected role as TIRC’s exclusive ibogaine supplier; the Company’s ability to secure pharmaceutical-grade drug substance and the regulatory documentation required to support a United States program; the evaluation, funding, design, timing and conduct of any clinical trial in Texas; the Company’s ability to obtain and maintain required registrations, permits, quotas and licenses; its ability to participate in federal or state ibogaine programs; and its expected role in future research, development and commercialization activities relating to ibogaine. Forward-looking statements may be identified by words such as “will,” “expects,” “intends,” “plans,” “anticipates,” “believes,” “estimates” and similar expressions.

These statements are based on assumptions regarding government policy, continued interest in regulated neuroplastogen research, the availability of lawful development pathways, and the Company’s ability to maintain licenses, permits, supply arrangements and third-party relationships, as well as assumptions that PsyLabs will apply the investment proceeds as intended and maintain its licenses, permits and facility standards; that Benuvia will perform its obligations under the manufacturing services agreement; that required DEA and other regulatory authorizations will be obtained on a timely basis; and that the Company will have access to sufficient financing to fund TIRC’s development activities. These assumptions may prove incorrect. Risks and uncertainties that could cause actual results to differ materially include: that the anticipated benefits of the investment in PsyLabs are not realized, or that PsyLabs does not apply the investment proceeds as intended; that the regulatory readiness documentation completed by PsyLabs does not support, or is not accepted by regulatory authorities in connection with, any future regulatory submission; that required board, shareholder, regulatory or stock exchange approvals are not obtained; that the previously announced share exchange is not completed, or is completed on terms that differ from those announced; that the cash investment and the other arrangements with PsyLabs are transactions between related parties, and that the terms agreed may differ from those that would be agreed between unrelated parties; that the valuation used to price the cash investment is not indicative of realizable value, and that the Company’s interest in PsyLabs, a privately held company, is illiquid; the reduction in the Company’s cash resources resulting from the investment; that a definitive agreement between TIRC and PsyLabs is not concluded by November 30, 2026, or at all, or is concluded on terms that differ from the term sheet; the Company’s dependence on PsyLabs, a related party, as exclusive supplier of ibogaine, and the risk of any interruption or failure in that supply; that DEA import permits, quotas, registrations or other regulatory approvals are delayed, limited or refused; that the Benuvia arrangements are terminated, not performed or do not proceed as intended; reliance on a single manufacturing partner and manufacturing, analytical or supply-chain failures; the capital commitments, regulatory obligations and contractual liabilities assumed by TIRC under the manufacturing services agreement and the Company’s ability to fund them; that U.S. funding or grant opportunities are not available to TIRC or are not obtained; changes in law, regulation or enforcement priorities in the United States, Southern Africa or elsewhere; the continuing status of ibogaine as a controlled substance; clinical, regulatory and approval risk; competition and market adoption risk; financing risk; and the Company’s ability to maintain compliance with Nasdaq continued listing standards. This list is not exhaustive. These risks should be considered together with the risk factors described in the “Risk Factors” section of the Company’s Annual Report on Form 20-F for the fiscal year ended March 31, 2026 and in the Company’s other filings with the U.S. Securities and Exchange Commission. Nothing in this communication should be regarded as a representation by any person that the forward-looking statements set forth herein will be achieved or that any of the contemplated results of such forward-looking statements will be achieved. Readers should not place undue reliance on forward-looking statements, which speak only as of the date made. Except as required by law, the Company undertakes no obligation to update such statements.

The Company makes no medical, treatment or health benefit claims regarding its proposed products. The U.S. Food and Drug Administration, Health Canada and other regulatory authorities have not approved ibogaine or the Company’s other neuroplastogen compounds for therapeutic use, and their safety and efficacy have not been established through authorized clinical research. Rigorous scientific research and clinical trials are required. Any references to ibogaine stock, inventory or doses are the Company’s best estimates only. References to GMP-compliant or cGMP mean production in a facility designed, operated and controlled in accordance with applicable Good Manufacturing Practice standards, and do not themselves constitute a representation of formal certification or approval by any regulatory authority unless expressly stated. Information regarding Benuvia and its facility is based on information provided by Benuvia and has not been independently verified by the Company. References to a planned clinical trial describe an activity under evaluation only; no trial has been commenced, and no regulatory application in respect of it has been filed or accepted. This communication is not an offer to sell or a solicitation of an offer to buy any securities.

Expansion supports growing demand for PyroGenesis’ technologies in one of the world’s fastest-growing industrial regions

MONTREAL, Oct. 21, 2026 (GLOBE NEWSWIRE) — PyroGenesis Inc. (“PyroGenesis” or the “Company”) (TSX: PYR) (OTCQX: PYRGF) (FRA: 8PY1), a leader in ultra-high temperature processes and engineering innovation, and a plasma-based technology provider to heavy industry & defense, announces today the establishment of a wholly-owned subsidiary in Dubai as a base to address the growing opportunities in the Middle East and Asian markets. The incorporation process began more than a year ago and recently received all required regulatory approvals from the UAE Government. The wholly owned subsidiary has been incorporated under the name PyroGenesis Global FZCO (“PyroGenesis Global”).

“This is long overdue given the inroads we have been making in these markets. The initial focus of PyroGenesis Global will be on the market opportunities we have been nurturing over the past six years, with a face-to-face presence. Notwithstanding our success to date, we have reached a point where we need to overcome the significant logistical challenges (time zone and distance) and demonstrate a commitment to the region,” said P. Peter Pascali, President and CEO of PyroGenesis. “The timing could not be better. The region combines significant access to capital with industrial development priorities that align closely with our technologies. Having said that, nothing can replace an on-the-ground presence. We intend to initially staff PyroGenesis Global with key business development personnel and senior decision makers. We are also considering gradually relocating select engineers, project managers, and support staff over in time. The Company may also evaluate localized sourcing and manufacturing capabilities to support regional growth.”

The launch of PyroGenesis Global aligns with significant industrial diversification initiatives underway across the region. These include Saudi Arabia’s Vision 2030 framework, which supports major industrial infrastructure projects such as the Ras Al-Khair Integrated Aluminum Complex.¹ The Ras Al-Khair complex is the largest in the world and already utilizes seven of PyroGenesis’ Drosrite™ aluminum dross processing systems.² The Company sees significant opportunities to further capitalize on these and other initiatives in the Middle East and Asia.

Image: Containers in the Port of Jebel Ali, Dubai, the world’s ninth busiest port and largest man-made harbour.

“The company needed to commit immediately to a temporary office space and it has done so, in the Uptown Tower DMCC on First Al Khail Street favoured by many Western satellite and regional offices, pending a relocation to a more suitable office space reflective of the Company’s growing needs,” said Mr. Pascali. “Our Dubai subsidiary solidifies our commitment to a region that offers tremendous capital flow. This capital supports large client projects and provides the platform for potential investments and partnerships. To underscore this point, we look forward to announcing a new partnership with a local entity in the region over the coming weeks, an entity that we have not done business with before. We believe these markets are well suited to a broad range of our technology offerings.”

About PyroGenesis Inc.

PyroGenesis leverages 35 years of plasma technology leadership to deliver advanced engineering solutions to energy, propulsion, destruction, process heating, emissions, and materials development challenges across heavy industry and defense. Its customers include global leaders in aluminum, aerospace, steel, iron ore, utilities, environmental services, military, and government. From its Montreal headquarters and local manufacturing facilities, PyroGenesis’ engineers, scientists, and technicians drive innovation and commercialization of energy transition and ultra-high temperature technology. PyroGenesis’ operations are ISO 9001:2015 and AS9100D certified, with ISO certification maintained since 1997. PyroGenesis’ shares trade on the TSX (PYR), OTCQX (PYRGF), and Frankfurt (8PY1) stock exchanges.

Cautionary and Forward-Looking Statements

This press release contains “forward-looking information” and “forward-looking statements” (collectively, “forward-looking statements”) within the meaning of applicable securities laws. In some cases, but not necessarily in all cases, forward-looking statements can be identified by the use of forward-looking terminology such as “plans”, “targets”, “expects” or “does not expect”, “is expected”, “an opportunity exists”, “is positioned”, “estimates”, “intends”, “assumes”, “anticipates” or “does not anticipate” or “believes”, or variations of such words and phrases or state that certain actions, events or results “may”, “could”, “would”, “might”, “will” or “will be taken”, “occur” or “be achieved”. In addition, any statements that refer to expectations, projections or other characterizations of future events or circumstances contain forward-looking statements. Forward-looking statements are not historical facts, nor guarantees or assurances of future performance but instead represent management’s current beliefs, expectations, estimates and projections regarding future events and operating performance. Forward-looking statements are necessarily based on a number of opinions, assumptions and estimates that, while considered reasonable by PyroGenesis as of the date of this release, are subject to inherent uncertainties, risks and changes in circumstances that may differ materially from those contemplated by the forward-looking statements. Important factors that could cause actual results to differ, possibly materially, from those indicated by the forward-looking statements include, but are not limited to, the risk factors identified under “Risk Factors” in PyroGenesis’ latest annual information form, and in other periodic filings that it has made and may make in the future with the securities commissions or similar regulatory authorities, all of which are available under PyroGenesis’ profile on SEDAR+ at www.sedarplus.ca. These factors are not intended to represent a complete list of the factors that could affect PyroGenesis. However, such risk factors should be considered carefully. There can be no assurance that such estimates and assumptions will prove to be correct. You should not place undue reliance on forward-looking statements, which speak only as of the date of this release. PyroGenesis undertakes no obligation to publicly update or revise any forward-looking statement, except as required by applicable securities laws. Neither the Toronto Stock Exchange, its Regulation Services Provider (as that term is defined in the policies of the Toronto Stock Exchange) nor the OTCQX Best Market accepts responsibility for the adequacy or accuracy of this press release.

For further information contact ir@pyrogenesis.com or visit http://www.pyrogenesis.com

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¹ https://vision2030.ai/sectors/mining/aluminium-industry/

² https://ir.pyrogenesis.com/news-releases/news-release-details/pyrogenesis-completes-seven-system-drosritetm-deployment-worlds

A photo accompanying this announcement is available at https://www.globenewswire.com/NewsRoom/AttachmentNg/315a2a7d-df5b-42b6-b6b9-4c32468fce6e