Author: Ravi Shankar

~ In 12 high-dose patients at 48 months, both cUHDRS and TFC continued to demonstrate meaningful slowing of disease progression and clear dose-dependent response; the primary endpoint of cUHDRS showed 44% slowing of disease progression (non-significant p=0.144) and TFC showed a 61% slowing of disease progression (nominal p=0.008) ~ 

~ Updated data reflecting all 15 high-dose patients showed substantial treatment effect on both cUHDRS and TFC at 36 months, the timepoint that is the regulatory anchor for the submitted BLA and the confirmatory study; the new analysis demonstrated 80% slowing of disease progression based on cUHDRS (nominal p=0.005) and 67% based on TFC (nominal p=0.011) ~ 

 ~ Treatment effect at 48 months likely understated by substantial missing data and survivor bias in updated external control; post hoc analysis using prior external control showed slowing of disease of 54% on cUHDRS (nominal p=0.041) and 68% on TFC (nominal p=0.001) at 48 months ~

~ These positive data are meaningful for Huntington’s disease patients who currently have no approved disease-modifying treatment options ~

~ Investor conference call and webcast today at 8:30 a.m. ET ~

LEXINGTON, Mass. and AMSTERDAM, Sept. 29, 2026 (GLOBE NEWSWIRE) — uniQure N.V. (NASDAQ: QURE), a leading gene therapy company advancing transformative therapies for patients with severe medical needs, today announced additional data from the ongoing Phase I/II studies of ifezuntirgene inilparvovec for the treatment of Huntington’s disease.

“Four years after a single administration, ifezuntirgene inilparvovec continues to show meaningful slowing of disease progression, further strengthening our conviction in its benefit for people living with Huntington’s disease,” stated Walid Abi-Saab, M.D., chief medical officer of uniQure. “At 48 months, Total Functional Capacity (TFC), the primary measure of our confirmatory study, demonstrated consistent slowing of functional decline, with the absolute treatment benefit maintained in Month 48. Furthermore, the observed differences between the high and low doses on both composite Unified Huntington’s Disease Rating Scale (cUHDRS) and TFC are consistent with a dose-dependent treatment effect. The updated 36-month analysis, which now includes three additional high-dose patients, showed a substantial effect on cUHDRS and TFC, further reinforcing the data included in our license applications. We believe these data are clinically meaningful for Huntington’s disease patients, and we look forward to presenting them at a future scientific meeting.”

Topline Clinical Data at 36 months and 48 months¹

Today’s announcement comprises results from the ongoing Phase I/II studies at two timepoints, with a data cutoff of June 30, 2026. Twenty-nine patients have been treated with ifezuntirgene inilparvovec (n=17 high dose; n=12 low dose) across the studies’ first two cohorts. The new 36-month analysis now includes 15 high-dose and 12 low-dose patients, with three additional high-dose patients having reached that timepoint since the September 2025 analysis. The 48-month analysis includes 12 patients at each dose.

Outcomes for the 36-month and 48-month analyses were compared to propensity score-matched external controls (n=1,337 for high dose) from an updated ENROLL-HD natural history dataset with a September 2025 cutoff. As is common with longitudinal natural history studies, missingness of data increased with duration of follow-up, reaching 53% in the updated ENROLL-HD matched controls at 48 months. The Company’s analysis of the updated control showed that patients discontinuing follow-up were progressing materially faster than those remaining in the control group. The Company believes these factors likely understated disease progression in the control and the resulting treatment effect of ifezuntirgene inilparvovec at 48 months.

At the June 2026 Type B meeting, the FDA communicated that the 36-month data from 12 high-dose patients would be acceptable as the primary basis for the BLA submission under the accelerated approval pathway, and the submission was made accordingly. The BLA submission of ifezuntirgene inilparvovec predated the topline results announced today and these results were not part of the submission.

High-Dose Results at 36 Months (n=15)

• cUHDRS showed 80% slowing of disease progression compared to the updated external control (nominal p=0.005). Treated patients had a mean change in cUHDRS from baseline of -0.28 compared to a change of -1.39 for the external control, a favorable treatment difference of 1.12 compared to baseline.

• TFC showed 67% slowing of disease progression compared to the updated external control (nominal p=0.011). Treated patients had a mean change in TFC from baseline of -0.27 compared to a change of -0.82 for patients in the propensity score-matched external control, a favorable treatment difference of 0.55 compared to baseline.
• Mean cerebrospinal neurofilament light protein (CSF NfL) was 6% below baseline (n=14).

High-Dose Results at 48 Months (n=12)

• cUHDRS showed a 44% slowing of disease progression compared to the updated external control and did not reach statistical significance (p=0.144). Treated patients had a mean change in cUHDRS from baseline of -0.90 compared to a change of -1.61 for the external control, a favorable treatment difference of 0.71 compared to baseline.
• TFC showed 61% slowing of disease progression compared to the updated external control (nominal p=0.008). Treated patients had a mean change in TFC from baseline of -0.37 compared to a change of -0.94 for the external control, a favorable treatment difference of 0.57 compared to baseline.
• In a post-hoc sensitivity analysis using the prior ENROLL-HD external control, the 48-month analysis showed 53.5% slowing based on cUHDRS (nominal p=0.041) and 68.3% based on TFC (nominal p=0.001).
• Mean cerebrospinal neurofilament light protein (CSF NfL) was 4% above baseline (n=11).

Dose Comparison at 48 Months (high dose n=12, low dose n=12)

• The observed differences between the high and low doses are consistent with a dose-dependent treatment effect. At 48 months, mean change from baseline in cUHDRS was –0.91 in high-dose patients compared with −1.94 in low-dose patients, a difference of 1.03 in favor of the high dose. Mean change from baseline in TFC was −0.30 in high-dose patients compared with −0.70 in low-dose patients, a difference of 0.40 in favor of the high dose.

“Huntington’s disease does not slow on its own; the biology is one of inevitable progressive decline,” stated Victor Sung, M.D., professor of neurology at the University of Alabama at Birmingham (UAB), director of the UAB Huntington’s Disease Clinic. “What I find particularly notable in the expanded data is the consistently meaningful treatment effect at 36 months, and the apparent stability of the functional capacity benefit through Month 48. We see this even as the rate of decline in the updated comparator dataset slowed, an anticipated shift which appears to reflect some attrition in the longitudinal external control data, and which does not reflect the typical clinical presentation of accelerating decline over time. Total Functional Capacity tracks things that matter the most to patients and families – ability to work, perform household chores and handle daily self-care activities. Seeing that treatment difference maintained at four years is meaningful for people living with this relentlessly progressive degenerative disease.”

Ifezuntirgene inilparvovec continues to be generally well-tolerated, with a manageable safety profile at both doses. The most common adverse events in the treatment groups were related to the administration procedure, and all have resolved. As previously disclosed, five high dose participants (17%) experienced a treatment-related serious adverse event (SAE) related to central nervous system inflammation, all of which fully resolved.

Since the September 2025 data readout, one suicide in a low-dose patient occurred, approximately five years after receiving treatment. This was assessed as unrelated to treatment by the study investigator. Suicidal ideation and completed suicide occur at substantially elevated rates in Huntington’s disease relative to the general population, and suicide is among the leading causes of death in those with the disease.

Investor Conference Call and Webcast Information 

uniQure management will host an investor conference call and webcast today, Tuesday, September 29 at 8:30 a.m. ET. The event will be webcast under the Events & Presentations section of uniQure’s website at https://www.uniqure.com/investors-media/events-presentations, and following the event a replay will be archived for 90 days. Analysts wishing to participate in the question and answer session should access the live call by dialing (646) 307-1963 or toll-free (800) 715-9871 and entering conference ID 5075555. If you are joining the conference call, please join 15 minutes before the start time.

About Ifezuntirgene Inilparvovec (AMT-130)

Ifezuntirgene inilparvovec is a novel gene therapy candidate for the treatment of Huntington’s disease, which utilizes a proprietary, gene-silencing miQURE^® platform and incorporates a miRNA, specifically designed to silence the huntingtin gene and the potentially highly toxic exon 1 protein fragment. Treated patients receive a single administration through targeted, MRI-guided, convection-enhanced stereotactic neurosurgical delivery directly into the striatum (caudate and putamen). Ifezuntirgene inilparvovec is the first investigational therapy for Huntington’s disease to have received Breakthrough Therapy and Regenerative Medicine Advanced Therapy (RMAT) designations from the FDA. Ifezuntirgene inilparvovec also holds Fast Track designation from the FDA.

About the Phase I/II Clinical Program of Ifezuntirgene Inilparvovec

uniQure is conducting two multi-center Phase I/II clinical studies evaluating the safety, tolerability, and efficacy of ifezuntirgene inilparvovec for the treatment of Huntington’s disease.

In total, the Phase I/II clinical studies have dosed 51 patients with ifezuntirgene inilparvovec. The U.S. randomized study enrolled 26 patients who received either a single administration of ifezuntirgene inilparvovec (n=6 low dose; n=10 high dose) or a sham procedure (n=10); four control patients subsequently crossed over to treatment after approximately 12 months. The European open-label study enrolled 13 patients (n=6 low dose; n=7 high dose). A third cohort of 12 patients explored both doses in combination with immunosuppression, and a fourth cohort of six U.S. patients is evaluating the high dose in patients with lower striatal volumes compared to those enrolled in previous cohorts.

Additional details are available on www.clinicaltrials.gov (NCT05243017, NCT04120493)

About Huntington’s Disease

Huntington’s disease is a rare, inherited neurodegenerative disorder that leads to motor symptoms including chorea, behavioral abnormalities and cognitive decline resulting in progressive physical and mental deterioration. The disease is an autosomal dominant condition with a disease-causing CAG repeat expansion in the first exon of the huntingtin gene that leads to the production and aggregation of abnormal protein in the brain. Approximately 75,000 people have Huntington’s disease in the U.S.², EU³, and the UK⁴, with hundreds of thousands of others at risk of inheriting the disease. Despite the clear etiology of Huntington’s disease, there are currently no approved therapies to delay the onset or to slow the disease’s progression.

About uniQure

uniQure is delivering on the promise of gene therapy – single treatments with potentially curative results. The approvals of uniQure’s gene therapy for hemophilia B – an historic achievement based on more than a decade of research and clinical development – represent a major milestone in the field of genomic medicine and ushers in a new treatment approach for patients living with hemophilia. uniQure is now advancing a pipeline of proprietary gene therapies for the treatment of patients with Huntington’s disease, refractory temporal lobe epilepsy, Fabry disease, and other severe diseases. www.uniQure.com

uniQure Forward-Looking Statements

This press release contains forward-looking statements within the meaning of Section 27A of the Securities Act and Section 21E of the Exchange Act. All statements other than statements of historical fact are forward-looking statements, which are often indicated by terms such as “anticipate,” “believe,” “could,” “establish,” “estimate,” “expect,” “goal,” “intend,” “look forward to,” “may,” “plan,” “potential,” “predict,” “project,” “seek,” “should,” “will,” “would” and similar expressions and the negatives of those terms. Forward-looking statements are based on management’s beliefs and assumptions and on information available to management only as of the date of this report. Examples of these forward-looking statements include, but are not limited to, statements concerning: the Company’s beliefs related to the factors that likely understate disease progression in the updated ENROLL-HD controls and the Company’s belief that ifezuntirgene inilparvovec meaningfully reduces disease progression based on its evaluation and view of certain measurements of disease progression. The Company’s actual results could differ materially from those anticipated in these forward-looking statements for many reasons. These risks and uncertainties include, among others: risks related to the Company’s Phase I/II clinical trials of ifezuntirgene inilparvovec, including the risk that such trials will be unable to continue to demonstrate data sufficient to support further clinical development or regulatory approval; the risk that the FDA ultimately concludes that the Phase I/II trial data are not sufficient to support a BLA or accelerated approval; the risk that more patient data become available that results in a different interpretation than the one derived from the year three and four data analyses, respectively; risks related to the Company’s interactions with regulatory authorities, which may affect the initiation, timing and progress of clinical trials and pathways to regulatory approval; whether the measurements that the Company is evaluating are viewed as robust and sensitive measurements of disease progression; whether RMAT designation, Breakthrough Therapy designation, or any accelerated pathway, if granted, will lead to regulatory approval; the Company’s ability to conduct and fund any required confirmatory study for ifezuntirgene inilparvovec; the Company’s ability to successfully complete any required confirmatory study for ifezuntirgene inilparvovec; the risk that accelerated approval, if granted, may be subject to post-approval requirements that are difficult or costly to satisfy; the Company’s ability to continue to build and maintain the infrastructure and personnel needed to commercialize ifezuntirgene inilparvovec, if approved; the Company’s effectiveness in managing current and future clinical trials and regulatory processes; the Company’s ability to demonstrate the therapeutic benefits of its gene therapy candidates in clinical trials; the continued development and acceptance of gene therapies; the Company’s ability to obtain, maintain and protect its intellectual property; and the Company’s ability to fund its operations and to raise additional capital as needed and on acceptable terms. These risks and uncertainties are more fully described under the heading “Risk Factors” in the Company’s periodic filings with the U.S. Securities & Exchange Commission (“SEC“), including its Annual Report on Form 10-K filed with the SEC on March 2, 2026, its Quarterly Report on Forms 10-Q filed with the SEC on May 5, 2026 and July 29, 2026, respectively, and in other filings that the Company makes with the SEC from time to time. Given these risks, uncertainties and other factors, you should not place undue reliance on these forward-looking statements and, except as required by law, the Company assumes no obligation to update these forward-looking statements, even if new information becomes available in the future.

uniQure Contacts:
FOR INVESTORS:	FOR MEDIA:
Chiara Russo Direct: 781-491-4371 Mobile: 617-306-9137 c.russo@uniQure.com	Tom Malone Direct: 339-970-7558 Mobile:339-223-8541 t.malone@uniQure.com

¹ cUHDRS is the pre-specified primary endpoint for the 48 months analysis; all other p-values are nominal. The 36-month data included 15 high-dose patients; the 48-month analysis included 12 high-dose patients. Percentage slowing was sensitive to the magnitude of decline in the external control.
² Yohrling G, et al. Neurology 2020;94(15 Suppl):954.
³ Medina A, et al. Mov Disord 2022;37(12):2327–2335
⁴ Furby H, et al. Eur J Neurol 2022;29(8):2249–2257.

Milestone Marks Recombinant Spider Silk’s Move from Scaled Production to a First-of-Its-Kind Performance Textile

ANN ARBOR, Mich., Sept. 29, 2026 (GLOBE NEWSWIRE) — Kraig Biocraft Laboratories, Inc. (OTCQB: KBLB) (“the Company”, “Kraig Labs”, or “Kraig’s”), a world leader in spider silk technology*, today announced the shipment of its first commercial order of recombinant spider silk yarn. The custom-engineered yarn was produced to fulfill a purchase commitment from a globally recognized performance sports brand and is slated for development into a first-of-its-kind performance textile.

This spider silk sale is part of a confidential pilot development program. The program targets one of the most demanding and innovation-focused segments of the athletic apparel market. The yarn has been custom processed to the customer’s specifications and has now shipped.

“Completing the delivery of this spider silk yarn is a huge milestone for Kraig Labs,” said Kim Thompson, Founder and CEO of Kraig Labs. “The volume is small by design. This is a precision application, not a bulk order. It is exactly the kind of application where spider silk’s real advantages can be highlighted. Strength, flexibility, toughness, and light weight, under conditions pushing materials to their limits. This application is a shining example of how spider silk can transform markets.”

The shipment comes at a pivotal moment for the global textile industry, as fashion and performance brands explore new materials while confronting the challenge of moving promising fiber technologies from laboratory innovation to reliable production. Textile Exchange’s Materials Market Report 2026, published September 22, reported that global fiber production reached a record 139 million metric tons in 2025, with polyester accounting for 59% of total output and 88% of polyester production coming from virgin fossil-based sources. Against that backdrop, the opportunity for emerging performance materials is significant, but so is the challenge: new fibers must deliver differentiated properties while proving they can be produced consistently and integrated into an industry built around enormous volumes of established materials. Kraig Labs’ first commercial shipment represents an important step from material innovation and scaled production toward real-world textile adoption.

Kraig Labs views elite performance apparel as one of the clearest proving grounds for recombinant spider silk. A category where gains in strength-to-weight ratio and durability translate directly into competitive advantage for the athlete.

“High-performance sport is where materials prove themselves,” Thompson continued. “Performance wins. That is the only thing that matters in elite sport. It’s about how it performs when everything is on the line, and that’s exactly what we intend to prove.”

While the quantity of silk in this shipment is small, Kraig Labs believes the true significance lies in what it represents for the broader athletic and performance textile market. A successful application here demonstrates that recombinant spider silk can meet the exacting technical standards of elite sport, standards few materials, natural or synthetic, are able to satisfy. A validated performance application of this kind opens the door to further engagement with brands across the performance apparel space.

“This is the kind of project that changes the conversation,” Thompson concluded. “When a brand at this level puts our material to the test, the results speak for themselves. We intend for this to be the first of many.”

The Company’s leadership in biomaterials was recently spotlighted on the cover of the March 2026 issue of National Geographic, highlighting the growing importance and predominance of our work in scaling spider silk production.

Interested persons can order a copy of National Geographic featuring Kraig Labs at https://ngsingleissues.nationalgeographic.com/natgeo-march-2026.

You can purchase a digital copy of the article directly from National Geographic at https://www.nationalgeographic.com/science/article/spider-silk-silkworm-genetic-engineering

For the latest updates on Kraig Labs and its pioneering spider silk technologies, visit www.kraiglabs.com.

For details about recent Kraig Labs advancements, please watch the Company’s investor updates at www.kraiglabs.com/videos or on the Company’s YouTube Channel https://www.youtube.com/@kraigbiocraftlaboratories2270.

To view the most recent news from Kraig Labs and/or to sign up for Company alerts, please go to www.KraigLabs.com/news   

* For a description of our historical leadership in this technology, please follow this link https://www.kraiglabs.com/world-leader/

Kraig Labs Technology is built on a scientifically engineered silkworm, which incorporates key spider silk proteins to produce recombinant spider silk.

About Kraig Biocraft Laboratories, Inc.

Kraig Biocraft Laboratories, Inc. (www.KraigLabs.com), a reporting biotechnology company is the leading developer of genetically engineered spider silk-based fiber technologies.

The Company has achieved a series of scientific breakthroughs in the area of spider silk technology with implications for the global textile industry.

Cautionary Statement Regarding Forward Looking Information

Statements in this press release about the Company’s future and expectations other than historical facts are “forward-looking statements.” These statements are made on the basis of management’s current views and assumptions. As a result, there can be no assurance that management’s expectations will necessarily come to pass. These forward-looking statements generally can be identified by phrases such as “believes,” “plans,” “expects,” “anticipates,” “foresees,” “estimated,” “hopes,” “if,” “develops,” “researching,” “research,” “pilot,” “potential,” “could” or other words or phrases of similar import. Forward looking statements include descriptions of the Company’s business strategy, outlook, objectives, plans, intentions and goals. All such forward-looking statements are subject to certain risks and uncertainties that could cause actual results to differ materially from those in forward-looking statements. This press release does not constitute an offer to sell or the solicitation of an offer to buy any security.

Ben Hansel, Hansel Capital, Inc.
(720) 288-8495
ir@KraigLabs.com

Photos accompanying this announcement are available at:

https://www.globenewswire.com/NewsRoom/AttachmentNg/656da44f-ba1b-467d-81d2-63af7e1d4a8e

https://www.globenewswire.com/NewsRoom/AttachmentNg/8621458d-87fb-47e9-b5e1-aaa6490608da 

• Resubmission of NDA includes Chemistry, Manufacturing, and Controls (CMC) data from a new drug product manufacturing vendor 
• The resubmission package includes 12 months of OLC drug product stability data from the new manufacturing vendor
• Company anticipates FDA acceptance of the NDA within 30 days of resubmission; new assigned PDUFA date expected to be 6 months from resubmission
• Current cash position allows runway into 2H 2027

MOUNTAIN VIEW, Calif., Sept. 29, 2026 (GLOBE NEWSWIRE) — Unicycive Therapeutics, Inc. (“Unicycive” or the “Company”) (Nasdaq: UNCY), a clinical-stage biotechnology company developing therapies for patients with kidney disease, today announced the resubmission of its New Drug Application (NDA) for oxylanthanum carbonate (OLC), the Company’s investigational oral phosphate binder for the treatment of hyperphosphatemia in patients with chronic kidney disease (CKD) on dialysis. The Company anticipates United States Food and Drug Administration (FDA) acceptance of the NDA within 30 days and a new assigned PDUFA date to be six months from the date of resubmission.

The NDA resubmission includes CMC data from a new third-party drug product manufacturing vendor. The new vendor’s facility was last inspected by the FDA in March 2024 and received “No Action Indicated” status, the highest FDA inspection classification indicating that a facility is in an acceptable state of current Good Manufacturing Practices (cGMP) compliance. The new vendor’s CMC data package includes technical specifications similar to the original third-party manufacturing vendor, and the new vendor has already produced OLC drug product and completed 12-month stability studies. In addition, the Company has provided additional in-vitro bridging data between the two vendors as recommended by the FDA in previous discussions.

In June 2026, the Company received a Complete Response Letter (CRL) from the FDA regarding the first OLC NDA resubmission. The 2026 CRL cited the same third-party manufacturing deficiencies identified in a previous CRL issued in June 2025 to the initial NDA submission, as a result of the FDA not having conducted the reinspection of the original third-party manufacturing vendor. The FDA did not raise concerns regarding clinical efficacy or safety data and did not request additional data from the Company. The Company’s original third-party manufacturing vendor has received written notification from the FDA that its facility inspection has been assigned, but the inspection has not yet occurred as of September 29, 2026. If the original third-party manufacturing vendor is inspected in the near term and deemed cGMP-compliant, the Company plans to seek FDA alignment on a shorter approval timeline for the OLC NDA resubmission. Unicycive intends to keep both drug product vendors to maintain supply chain redundancy.

“We believe this resubmission reflects an efficient path to potential approval and, if approved, a potentially faster path to bringing OLC to patients who need additional treatment options,” said Shalabh Gupta, M.D., Chief Executive Officer of Unicycive. “By adding an alternative primary manufacturing vendor, we are positioning the NDA for expedient review and potential approval. If the FDA’s assigned inspection of the original vendor is completed favorably in the interim, that outcome could provide a potential timing benefit. We continue to advance commercial readiness activities in anticipation of a potential launch, with the goal of helping patients with CKD on dialysis who continue to struggle with hyperphosphatemia.”

The NDA is supported by data from three clinical studies: a Phase 1 study in healthy volunteers, a bioequivalence study in healthy volunteers, and a tolerability study of OLC in CKD patients on dialysis, along with multiple preclinical studies and CMC data.

As of June 30, 2026, unaudited cash, cash equivalents and marketable securities totaled $61.4 million, supporting continued OLC commercial launch preparation and an expected cash runway into the second half of 2027.

About Oxylanthanum Carbonate
OLC is an investigational oral phosphate binder that leverages proprietary nanoparticle technology to deliver high phosphate binding potency, reducing the number and size of pills that patients must take to treat hyperphosphatemia in patients with chronic kidney disease (CKD) on dialysis. Its potential best-in-class profile may have meaningful patient adherence benefits over currently available treatment options as it requires a lower pill burden. Unicycive is seeking FDA approval of OLC via the 505(b)(2) regulatory pathway. OLC is protected by a strong global patent portfolio including issued patents on composition of matter with exclusivity until 2031, and with the potential for patent term extension until 2035.

About Hyperphosphatemia
Hyperphosphatemia is a serious medical condition that occurs in nearly all patients with End Stage Renal Disease (ESRD). Annually there are over 450,000 individuals in the U.S. that require medication to control their phosphate levels.¹ Uncontrolled hyperphosphatemia is strongly associated with increased death and hospitalization for CKD patients on dialysis. Treatment of hyperphosphatemia is aimed at lowering serum phosphate levels via two means: (1) restricting dietary phosphorus intake; and (2) using, on a daily basis, and with each meal, oral phosphate binding drugs that facilitate fecal elimination of dietary phosphate rather than its absorption from the gastrointestinal tract into the bloodstream.

¹Flythe JE. Dialysis-Past, Present, and Future: A Kidney360 Perspectives Series. Kidney360. 2023 May 1;4(5):567-568. doi: 10.34067/KID.0000000000000145.

About Unicycive Therapeutics

Unicycive Therapeutics is a biotechnology company developing novel treatments for kidney diseases. Unicycive’s lead investigational treatment is oxylanthanum carbonate, a novel phosphate binding agent for the treatment of hyperphosphatemia in patients with chronic kidney disease who are on dialysis. Unicycive’s second investigational treatment UNI-494 is intended for the treatment of conditions related to acute kidney injury. It has been granted orphan drug designation (ODD) by the FDA for the prevention of Delayed Graft Function (DGF) in kidney transplant patients and has completed a Phase 1 dose-ranging safety study in healthy volunteers. For more information, please visit Unicycive.com and follow us on LinkedIn and X.

Forward-looking statements

Certain statements in this press release are forward-looking within the meaning of the Private Securities Litigation Reform Act of 1995. These statements may be identified using words such as “anticipate,” “believe,” “forecast,” “estimated” and “intend” or other similar terms or expressions that concern Unicycive’s expectations, strategy, plans or intentions. These forward-looking statements are based on Unicycive’s current expectations and actual results could differ materially. There are several factors that could cause actual events to differ materially from those indicated by such forward-looking statements. These factors include, but are not limited to, clinical trials involve a lengthy and expensive process with an uncertain outcome, and results of earlier studies and trials may not be predictive of future trial results; our clinical trials may be suspended or discontinued due to unexpected side effects or other safety risks that could preclude approval of our product candidates; our dependence on third parties for manufacturing; the possibility that FDA may require inspection of any vendor prior to approval, which could delay or prevent approval of our NDA; the risk that the original third-party manufacturing vendor’s reinspection may not occur within a timeframe that benefits our regulatory timeline, or may result in adverse findings; risks related to business interruptions, which could seriously harm our financial condition and increase our costs and expenses; dependence on key personnel; substantial competition; uncertainties of patent protection and litigation; dependence upon third parties; market acceptance of our products; and risks related to failure to obtain FDA clearances or approvals and noncompliance with FDA regulations. Actual results may differ materially from those indicated by such forward-looking statements as a result of various important factors, including: the uncertainties related to market conditions and other factors described more fully in the section entitled ‘Risk Factors’ in Unicycive’s Annual Report on Form 10-K for the year ended December 31, 2025, and other periodic reports filed with the Securities and Exchange Commission. Any forward-looking statements contained in this press release speak only as of the date hereof, and Unicycive specifically disclaims any obligation to update any forward-looking statement, whether as a result of new information, future events or otherwise.

Investor Contacts:
Kevin Gardner
LifeSci Advisors
kgardner@lifesciadvisors.com

Media Contact:
Unicycive Therapeutics
media@unicycive.com 

SOURCE: Unicycive Therapeutics, Inc.

LOS ANGELES, Sept. 29, 2026 (GLOBE NEWSWIRE) — Immix Biopharma, Inc. (“ImmixBio”, “Company”, “we” or “us” or “IMMX”), a global leader in relapsed/refractory AL Amyloidosis, today announced the pricing of an underwritten registered offering of 11,363,637 shares of its common stock at a public offering price of $11.00 per share. The gross proceeds from this offering are expected to be $125 million, before deducting underwriting discounts and commissions and offering expenses payable by the Company. The offering is expected to close on or about September 30, 2026, subject to the satisfaction of customary closing conditions.

Immix intends to use the net proceeds from this offering to fund NXC-201 development, working capital and general corporate purposes.

J.P. Morgan is acting as the sole book-running manager for the offering. The offering included participation from new and existing institutional investors, including Eventide Asset Management, Janus Henderson Investors, Ridgeback Capital Investments L.P., Wellington Management and other leading U.S. biotechnology institutional investors and mutual funds.

The shares of common stock described above are being offered and sold by the Company pursuant to a shelf registration statement on Form S-3 (File No. 333-292665), including a base prospectus, filed with the U.S. Securities and Exchange Commission (the “SEC”) on January 9, 2026, and declared effective on January 22, 2026. A prospectus supplement and accompanying prospectus describing the terms of the offering will be filed with the SEC and will be available on the SEC’s website located at www.sec.gov. Copies of the prospectus supplement and the accompanying prospectus related to this offering, when available, may be obtained from J.P. Morgan Securities LLC, c/o Broadridge Financial Solutions, 1155 Long Island Avenue, Edgewood, New York 11717, or by email at prospectus-eq_fi@jpmchase.com and postsalemanualrequests@broadridge.com.

This press release shall not constitute an offer to sell or the solicitation of an offer to buy any of the securities described herein, nor shall there be any sale of these securities in any state or other jurisdiction in which such offer, solicitation or sale would be unlawful prior to the registration or qualification under the securities laws of any such state or other jurisdiction.

About Immix Biopharma, Inc.

Immix Biopharma, Inc. (ImmixBio) (Nasdaq: IMMX) is a global leader in AL Amyloidosis. AL Amyloidosis is a devastating disease where the immune system, that’s supposed to protect, instead produces toxic light chains, clogging up the heart, kidney and liver, causing organ failure and death. Our lead candidate is sterically-optimized BCMA-targeted chimeric antigen receptor T (CAR-T) cell therapy NXC-201 with a proprietary CD3ζ, CD8 hinge and binder “digital filter” designed to filter out non-specific activation. NXC-201 teaches the immune system to recognize and eliminate the source of the toxic light chains. NXC-201 is being evaluated in the U.S. multi-center study for relapsed/refractory AL Amyloidosis NEXICART-2 (NCT06097832), with a potentially registrational design. NXC-201 has been awarded Breakthrough Therapy Designation (BTD) and Regenerative Medicine Advanced Therapy (RMAT) by the US FDA and Orphan Drug Designation (ODD) by FDA and in the EU by the EMA.

Forward Looking Statements

This press release contains forward-looking statements within the meaning of the federal securities laws. Words such as “may,” “might,” “will,” “should,” “believe,” “expect,” “anticipate,” “estimate,” “continue,” “predict,” “forecast,” “project,” “plan,” “intend” or similar expressions, or statements regarding intent, belief, or current expectations, are forward-looking statements. These forward-looking statements are based upon current estimates and assumptions and include statements relating to the offering, including the timing of the closing of the offering, the anticipated use of proceeds therefrom, the potential benefits of the Company’s product candidate CAR-T NXC-201 and the timing and results related to clinical trials, including planned trials. While the Company believes these forward-looking statements are reasonable, undue reliance should not be placed on any such forward-looking statements, which are based on information available to us on the date of this release. These forward-looking statements are subject to various risks and uncertainties, many of which are difficult to predict that could cause actual results to differ materially from current expectations and assumptions from those set forth or implied by any forward-looking statements. Important factors that could cause actual results to differ materially from current expectations include, among others, risks and uncertainties relating to market conditions; the completion of the proposed offering on the anticipated terms or at all; the risk that the estimates for the number of patients in the U.S. with relapsed/refractory AL Amyloidosis and the market size are not accurate; the risk that further data from the ongoing Phase 1/2 clinical trials for NXC-201  will not be favorably consistent with the data readouts to date; that no drug product developed by the Company has received FDA pre-market approval or otherwise been incorporated into a commercial drug product; that success in early phases of pre-clinical and clinicals trials do not ensure later clinical trials will be successful; and those other risks disclosed in the section “Risk Factors” included in the Company’s Annual Report on Form 10-K for the fiscal year ended December 31, 2025 and other periodic or current reports subsequently filed with the Securities and Exchange Commission. These reports are available at www.sec.gov. Immix Biopharma cautions that the foregoing list of important factors is not complete. Immix Biopharma cautions readers not to place undue reliance on any forward-looking statements. Immix Biopharma does not undertake, and specifically disclaims, any obligation to update or revise such statements to reflect new circumstances or unanticipated events as they occur, except as required by law. If we update one or more forward-looking statements, no inference should be drawn that we will make additional updates with respect to those or other forward-looking statements.

Contacts:

Mike Moyer
LifeSci Advisors
mmoyer@lifesciadvisors.com

Company Contact
irteam@immixbio.com

Bang & Olufsen is publishing preliminary Q1 2026/27 figures after becoming aware that certain preliminary figures contained in a confidential draft internal working document were inadvertently disclosed to a Danish business media due to an email sent in error by an external PR agency. The Q1 2026/27 trading statement was originally planned for publication on 7 October 2026 but will now be published on 30 September 2026 at around 8.00 CEST followed by a conference call for analysts and investors at 10.00 CEST.

The preliminary figures for Q1 2026/27 are as follows:

• Like-for-like sell-out growth of 7% y-o-y and 14% in branded channels. 19% sell-out growth combined in Win Cities
• Group revenue of DKK 530m, equivalent to a 2.2% increase in local currencies and revenue in our branded channels grew by 9.9% in local currencies
• In terms of product categories, revenue from the Staged category grew by 9% and revenue from the Flexible Living category grew by 16%, reflecting increased sales in the branded channels. Revenue from the On-the-go category declined by 19%, reflecting lower sales in the etail channel.
• Gross margin of 59.4%, corresponding to an improvement of 0.7 pp year-on-year
• EBIT before special items of DKK -23m, and EBIT margin before special items of -4.3%
• Free cash flow of DKK 6m
• Net available liquidity was DKK 80m and capital resources were DKK 230m

The FY 2026/27 outlook is maintained and is as follows:

Revenue growth in local currencies:	1% to 5%
EBIT margin before special items:	1% to 3%
Free cash flow:	DKK 25m to DKK 100m

For further details on assumptions, please see annual report 2025/26.

Q1 2026/27 conference call
30 September 2026, at 10.00 CEST via https://bo.nexahub.io/events/trading-statement-1st-quarter-202627

Dial-in details (Pin: 193621):
DK: +45 78768490
UK: +44 2037696819
US: +1 6467870157

For further information, please contact:

Cristina Rønde Hefting
Sr. Director, Head of Strategy & Investor Relations
Phone: +45 4153 7303

Peter Hobolt Jensen
Corporate communications
Phone: +45 4153 7282

Attachment

• BO_2620_CA_Q1 preliminary figures

MALVERN, Pa., Sept. 29, 2026 (GLOBE NEWSWIRE) — Ocugen, Inc. (Ocugen or the Company) (NASDAQ: OCGN), a pioneering biotechnology company developing gene therapies for blindness diseases, today announced that members of its executive leadership team will present at two upcoming investor and industry conferences.

H.C. Wainwright: Biotech on Tap 2026
Location: EY Auditorium, Munich, Germany
Date: Thursday, October 1, 2026
Time: 1:45–2:30 p.m. CEST
Format: Panel discussion
Title: Structured Finance Solutions: Royalty, Credit and Other Alternative Financing Options for Life Sciences
Presenter: Session Moderator — Dr. Shankar Musunuri, Chairman, CEO, and Co-Founder, Ocugen

Cell & Gene Meeting on the Mesa 2026
Location: Arizona Biltmore, Phoenix, AZ
Date: Tuesday, October 6, 2026
Time: 2:15–3:15 p.m. MST
Format: Panel discussion
Title: Navigating the Road to Approval, Commercialization, and the Future of Cell and Gene Therapy
Presenter: Dr. Shankar Musunuri, Chairman, CEO, and Co-Founder, Ocugen

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, 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. 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

• VYD2311 met all primary and secondary endpoints comparing VYD2311 to an mRNA-based COVID-19 vaccine, demonstrating VYD2311 safety and tolerability that is clinically and statistically superior to the safety and tolerability of an mRNA-based COVID-19 vaccine
• VYD2311 combined with an mRNA-based COVID-19 vaccine demonstrated no interference with vaccine-induced neutralizing titers, and instead added substantially to vaccine-induced neutralizing titers
• VYD2311 observed profile in LIBERTY indicates high measured neutralizing antiviral titers supporting the target profile for VYD2311 under study in the DECLARATION pivotal clinical study
• Invivyd plans for DECLARATION and LIBERTY clinical studies to be the basis of a planned Biologics License Application (BLA) submission for VYD2311 to the U.S. Food and Drug Administration via Accelerated Approval Program following a recent Type C meeting; DECLARATION topline data on safety and immunogenicity to support the submission are now expected in October; DECLARATION clinical efficacy data will be planned to be unblinded post-Accelerated Approval, if granted, subject to clinical event accrual
• Investor call to be held at 8:30 am ET on September 29, 2026

NEW HAVEN, Conn., Sept. 29, 2026 (GLOBE NEWSWIRE) — Invivyd, Inc. (Nasdaq: IVVD) today announced positive, clinically meaningful, and statistically significant topline data from the LIBERTY Phase 3, randomized, double-blind, active controlled study evaluating the safety and tolerability of (1) VYD2311, Invivyd’s investigational COVID-directed monoclonal antibody candidate, (2) mRNA-based COVID-19 vaccine COMIRNATY® (mRNA-based COVID-19 vaccine, COVID-19 mRNA vaccine, or COVID vaccine), and (3) VYD2311 co-administered with mRNA-based COVID-19 vaccine. The study also evaluated the potential for immunologic interference between VYD2311 and mRNA-based COVID-19 vaccine. LIBERTY is a companion study to DECLARATION, the ongoing placebo-controlled pivotal study of VYD2311 for pre-exposure prophylaxis of symptomatic COVID-19.

LIBERTY’s co-primary endpoints evaluated the proportion of subjects experiencing a treatment-emergent adverse event (TEAE), injection site reaction (ISR), or hypersensitivity reaction over the first 6 days following dosing, and the proportion of subjects experiencing a systemic adverse event (AE) solicited via an e-diary over the first 6 days following dosing. The key secondary endpoint evaluated the proportion of subjects experiencing a TEAE, ISR, or hypersensitivity reaction over the full 56 days of the study following dosing.

“We are thrilled to report on this landmark study. LIBERTY has generated the first Phase 3, randomized, blinded, controlled data we are aware of in history that compare different mechanisms for achieving immunization in vulnerable humans: the specific, highly potent investigational monoclonal antibody VYD2311, and an approved mRNA-based COVID-19 vaccine currently in wide clinical use. The observed profile of VYD2311 in LIBERTY and measured in vitro potency data of VYD2311 against circulating variants leave us confident and looking forward to the placebo-controlled safety and immunogenicity data we expect shortly in the DECLARATION study,” said Marc Elia, Chairman and CEO of Invivyd. “We want to move as quickly as possible to the regulatory filings required to bring Americans a new choice in protection from COVID.”

LIBERTY recruited 210 healthy adults (18-49 years) and randomized subjects 1:1:1 to receive a single intramuscular dose of either 250mg VYD2311, COMIRNATY® (COVID-19 vaccine, mRNA), or the combination of VYD2311 and mRNA-based COVID-19 vaccine. Both single dose arms were blinded with a concomitant placebo injection such that every subject in LIBERTY received two injections irrespective of treatment arm. All subjects were dosed using intramuscular needles consistent with COVID-19 vaccination, and, for blinding purposes, placebo injections were volume-matched to either VYD2311 (2mL) or COVID-19 vaccine (0.5mL). The 250mg VYD2311 dose studied in LIBERTY is the same dose under evaluation in the DECLARATION study in single and multiple-dose arms.

Clinical Data

Primary and key secondary endpoint data from LIBERTY along with accompanying statistical analysis results are provided below:

Co-Primary Endpoint 1: Short Term (6 Days) Overall Safety and Tolerability Percent of subjects experiencing any TEAE, ISR, or hypersensitivity for 6 days post-administration
Treatment Arm	%		Comparator	%		Significance
VYD2311	56.5	%	COVID-19 mRNA vaccine	91.4	%	P <0.0001
Combination VYD2311 + COVID-19 mRNA vaccine	78.9	%	COVID-19 mRNA vaccine	91.4	%	P = 0.057
COVID-19 mRNA vaccine	91.4	%	N/A

Co-Primary Endpoint 2: Short Term (6 Days) Systemic AEs Percent of subjects experiencing systemic AEs solicited via e-diary for 6 days post-administration
Treatment Arm	%		Comparator	%		Significance
VYD2311	44.1	%	COVID-19 mRNA vaccine	68.1	%	P = 0.008
Combination VYD2311 + COVID-19 mRNA vaccine	50.0	%	COVID-19 mRNA vaccine	68.1	%	P = 0.023
COVID-19 mRNA vaccine	68.1	%	N/A

Key Secondary Endpoint: Long Term (56 Days) Overall Safety and Tolerability Percent of subjects experiencing any TEAE, ISR, or hypersensitivity for 56 days post-administration
Treatment Arm	%		Comparator	%		Significance
VYD2311	60.9	%	COVID-19 mRNA vaccine	91.4	%	P <0.0001
Combination VYD2311 + COVID-19 mRNA vaccine	83.1	%	COVID-19 mRNA vaccine	91.4	%	P = 0.21
COVID-19 mRNA vaccine	91.4	%	N/A

LIBERTY data demonstrate the favorable safety and tolerability of VYD2311 across both early and late follow-up time periods compared to COVID-19 mRNA vaccine. Of note, no AEs related to VYD2311 were higher than Grade 2, and no hypersensitivity or anaphylaxis was observed with VYD2311 or in any arm of the LIBERTY study.

Vaccine-induced neutralizing antiviral titers were analyzed to identify any immunologic interference between VYD2311 and COVID-19 mRNA vaccine. The data demonstrate that VYD2311 added to the COVID-19 mRNA vaccine increased the neutralizing titers from COVID-19 mRNA vaccine alone by approximately 2.5x over the 56-day study. To identify the vaccine’s role within the combination neutralizing titers, Invivyd removed VYD2311 from the combination samples. Neutralizing titers from these VYD2311-depleted samples are essentially identical to the neutralizing titers observed in the monotherapy mRNA-based COVID-19 vaccine arm, confirming lack of immunologic interference.

VYD2311 observed pharmacokinetics, while pending definitive demonstration in the DECLARATION study, demonstrated results in LIBERTY consistent with Invivyd’s expectations. These data, combined with VYD2311 in vitro potency data against circulating variants, allow Invivyd to estimate neutralizing antiviral titers consistent with Invivyd’s target profile of VYD2311 under evaluation in DECLARATION.

The VYD2311 and COVID-19 mRNA vaccine combination arm data and comparative analyses suggest that dosing VYD2311 concomitant with COVID-19 mRNA vaccine may improve the safety and tolerability of COVID-19 mRNA vaccine while also adding substantially to neutralizing antiviral titers from the combination. This finding provides an area of potential future clinical study for Invivyd within COVID and other disease areas, consistent with Invivyd’s broad early-stage antiviral monoclonal antibody pipeline.

VYD2311 Regulatory Submission Plans

Invivyd has been in constructive ongoing dialogue with the U.S. Food and Drug Administration (FDA) regarding regulatory pathways for VYD2311, including a recent Type C meeting in September and other discussions with FDA leadership. As a result of those discussions, Invivyd intends to submit a BLA under the Accelerated Approval Program pending results from the ongoing DECLARATION pivotal study.

Invivyd, therefore, plans to unblind and report the placebo-controlled safety and neutralizing antiviral titers of VYD2311 in the DECLARATION study, while keeping blinded clinical events collected to date. If the data are supportive, Invivyd intends to pursue Accelerated Approval based on DECLARATION and LIBERTY data, along with reference to prior Invivyd monoclonal antibody data. Invivyd then plans to continue accumulating PCR-positive symptomatic COVID-19 pooled, blinded events in a post-approval confirmatory randomized cohort to enhance statistical powering of target efficacy (70%-90% relative risk reduction in PCR+ symptomatic COVID-19 versus placebo). Invivyd believes that as an evidence base, data from LIBERTY, and the upcoming safety and neutralizing titers DECLARATION data on VYD2311, if positive, combined with data from previous Invivyd randomized, placebo-controlled trials EVADE (adintrevimab) and CANOPY (pemivibart) compare favorably to the evidentiary basis routinely used to approve updated COVID vaccines, which also change compositionally to a similar extent as Invivyd monoclonal antibodies.

“The LIBERTY data provide us with high confidence in the profile of VYD2311. With placebo-controlled safety and neutralizing antiviral titer data for VYD2311 still pending from the DECLARATION study, this formal comparison of VYD2311 to standard of care COVID-19 mRNA vaccine provides an important window into VYD2311’s clinical profile,” commented Michael Mina, M.D., Ph.D., Chief Medical Officer and Chief Epidemiologist of Invivyd. “Today’s LIBERTY data alone, even before DECLARATION data, provide more robust contemporary human clinical information than the data associated with recently approved updated COVID-19 vaccines, leaving us enthusiastic about moving forward toward BLA submission and rapidly serving vulnerable populations, if approved. With regard to the combination of VYD2311 and COVID-19 vaccine, we are intrigued and gratified that the combination may enhance vaccination by reducing unwelcome vaccine-related adverse events, while simultaneously adding the substantial virus neutralizing activity of a highly active monoclonal antibody. This finding suggests potentially broader, as yet unexplored, complementarity between Invivyd monoclonal antibodies and vaccines against COVID-19 and perhaps other pathogens.”

Conference Call & Webcast
Listeners can register for the webcast via this link. Analysts wishing to participate in the question-and-answer session should use this link. A replay of the webcast will be available via the company’s investor website approximately two hours after the call’s conclusion. Those who plan on participating are advised to join 15 minutes prior to the start time.

About VYD2311 
VYD2311 is a novel monoclonal antibody (mAb) candidate being developed for COVID-19 to continue to address the urgent need for new prophylactic and therapeutic options. The pharmacokinetic profile and antiviral potency of VYD2311 may offer the ability to deliver clinically meaningful titer levels through more patient-friendly means such as an intramuscular route of administration. 

VYD2311 was engineered using Invivyd’s proprietary integrated technology platform and is the product of serial molecular evolution designed to generate an antibody optimized for neutralizing contemporary virus lineages. VYD2311 leverages the same antibody backbone as pemivibart, Invivyd’s investigational mAb granted emergency use authorization in the U.S. for the pre-exposure prophylaxis (PrEP) of symptomatic COVID-19 in certain immunocompromised patients, and adintrevimab, Invivyd’s investigational mAb that has a robust safety data package and demonstrated clinically meaningful results in global Phase 2/3 clinical trials for the prevention and treatment of COVID-19. 

About LIBERTY
LIBERTY is a Phase 3, randomized, double-blind clinical trial to evaluate the safety, serum virus neutralizing antibody responses, and pharmacokinetics of VYD2311, an mRNA COVID vaccine, and co-administered VYD2311 with an mRNA COVID vaccine. Total enrollment of the trial is approximately 210 participants.

About DECLARATION
DECLARATION is a Phase 3, randomized, triple-blind, placebo-controlled trial to evaluate VYD2311 efficacy and safety in prevention of symptomatic COVID in a broad population of participants including adults and adolescents both with and without risk factors for progression to severe COVID-19 at three months. Participants will receive either a single dose or monthly doses of VYD2311, each administered via intramuscular (IM) injection, compared to placebo. Total enrollment of the trial is approximately 2,400 participants.

About Invivyd 
Invivyd, Inc. (Nasdaq: IVVD) is a biopharmaceutical company devoted to delivering protection from serious viral infectious diseases, beginning with SARS-CoV-2. Invivyd deploys a proprietary integrated technology platform unique in the industry designed to assess, monitor, develop, and adapt to create best in class antibodies. In March 2024, Invivyd received emergency use authorization (EUA) from the U.S. FDA for a monoclonal antibody (mAb) in its pipeline of innovative antibody candidates. Visit https://invivyd.com/ to learn more.

Trademarks are the property of their respective owners.

Cautionary Note Regarding Forward-Looking Statements
This press release contains forward-looking statements within the meaning of the Private Securities Litigation Reform Act of 1995. Words such as “anticipates,” “believes,” “could,” “expects,” “estimates,” “intends,” “plans,” “potential,” “predicts,” “projects,” “future,” and “target” or similar expressions (as well as other words or expressions referencing future events, conditions or circumstances) are intended to identify forward-looking statements. Forward-looking statements include statements concerning, among other things, plans related to the company’s research and development activities, and the timing and potential results thereof, including with respect to the DECLARATION pivotal clinical trial; expectations regarding the company’s anticipated regulatory pathway, product profile, indication, patient populations, and administration paradigm for VYD2311, including the company’s plans to submit a BLA for VYD2311 to the FDA via Accelerated Approval Program; expectations regarding the public health landscape, potential advantages of mAbs, and potential complementarity between vaccines and Invivyd mAbs; potential future areas of clinical study for Invivyd; the potential of VYD2311 as a novel mAb candidate that may be able to deliver clinically meaningful titer levels through more patient-friendly means, and expectations about the clinical profile of VYD2311; the company’s strategies and objectives; the company’s future prospects; and other statements that are not historical fact. The company may not actually achieve the plans, intentions, or expectations disclosed in the company’s forward-looking statements, and you should not place undue reliance on the company’s forward-looking statements. These forward-looking statements involve risks and uncertainties that could cause the company’s actual results to differ materially from the results described in or implied by the forward-looking statements, including, without limitation: the timing, progress, and results of the company’s discovery, preclinical, and clinical development activities, including implementation of any necessary protocol amendments; uncertainties regarding clinical trial event accumulation rates and statistical powering; the risk that results of nonclinical studies or clinical trials may not be predictive of future results, and interim data are subject to further analysis; unexpected safety or efficacy data observed during preclinical studies or clinical trials; the predictability of clinical success of the company’s product candidates based on neutralizing activity in nonclinical studies; changes in the regulatory environment; the outcome of the company’s engagement with regulators; uncertainties related to the regulatory approval process, and available development and regulatory pathways; the company’s ability to generate the data needed to support its planned BLA submission for VYD2311, and uncertainties regarding the FDA’s acceptance and review of any such BLA submission; potential variability in neutralizing activity of product candidates tested in different assays, such as pseudovirus assays and authentic assays; variability of results in models and methods used to predict activity against SARS-CoV-2 variants; whether the epitope that VYD2311 targets remains structurally intact and the company’s product candidates are able to demonstrate and sustain neutralizing activity against major SARS-CoV-2 variants, particularly in the face of viral evolution; the ability to maintain a continued acceptable safety, tolerability, and efficacy profile of any product candidate following regulatory authorization or approval; the risk that a lack of awareness of mAb therapies and regulatory scrutiny of mAb therapies may adversely impact the development or commercial success of the company’s product candidates; changes in expected or existing competition; the company’s reliance on third parties; complexities of manufacturing mAb therapies; macroeconomic and political uncertainties; and whether the company has adequate funding to meet future operating expenses and capital expenditure requirements. Other factors that may cause the company’s actual results to differ materially from those expressed or implied in the forward-looking statements in this press release are described under the heading “Risk Factors” in the company’s Annual Report on Form 10-K for the year ended December 31, 2025, and its Quarterly Report on Form 10-Q for the quarter ended June 30, 2026, each as filed with the Securities and Exchange Commission (SEC), and in the company’s other filings with the SEC, and in its future reports to be filed with the SEC and available at www.sec.gov. Forward-looking statements contained in this press release are made as of this date, and Invivyd undertakes no duty to update such information whether as a result of new information, future events or otherwise, except as required under applicable law.

This press release contains hyperlinks to information that is not deemed to be incorporated by reference in this press release.

Contacts:

Media Relations
(781) 208-0160
media@invivyd.com

Investor Relations
(781) 208-1747
investors@invivyd.com

• FDA Fast Track designation represents an important regulatory milestone for the Plinabulin and docetaxel combination as an anticancer regimen in 2L/3L advanced or metastatic non-squamous NSCLC without actionable genomic alterations (AGAs) following progression on immune checkpoint inhibitor (ICI) and chemotherapy.
• BeyondSpring enters into a strategic transaction to sell its majority equity interest in its Chinese subsidiary to an investor who will fund the China portion of the Phase 3 DUBLIN-4 trial, which is expected to represent approximately 50% of the planned global enrollment of 442 patients.
• This non-dilutive transaction provides a financially efficient path toward the next major clinical milestone for Plinabulin, which is DUBLIN-4 interim analysis of 221 Progression-Free Survival (PFS) events.
• Management will host a conference call and webcast today at 8:00 a.m. ET to discuss these developments.

FLORHAM PARK, N.J., Sept. 29, 2026 (GLOBE NEWSWIRE) — BeyondSpring Inc. (NASDAQ: BYSI) (“BeyondSpring” or the “Company”), a clinical-stage company developing innovative therapies for the treatment of cancer and other diseases, today announced that the U.S. Food and Drug Administration (“FDA”) has granted Fast Track designation to Plinabulin and docetaxel for the treatment of patients with advanced or metastatic non-squamous non-small cell lung cancer (“NSCLC”) without actionable genomic alterations (AGAs) whose disease has progressed following prior anti-PD-(L)1 antibody therapy and platinum-based chemotherapy, representing patients in the second- or third-line treatment setting. This is the patient population being studied in BeyondSpring’s global Phase 3 DUBLIN-4 trial.

Plinabulin, a first-in-class small molecule agent, has an extensive clinical safety database with more than 700 cancer patients. Its differentiated immuno-modulating mechanism and previously reported encouraging clinical data from DUBLIN-3 and Study 303 support the trial design of DUBLIN-4 in Plinabulin mechanism-targeted post-ICI non-squamous NSCLC patients.

The Company also announced a strategic transaction with Biolin Investment Limited (“Biolin”) relating to the China portion of DUBLIN-4. Under the arrangement, the Company will sell its majority equity interest in its Chinese subsidiary, and Biolin will support DUBLIN-4 clinical development activities in China, which activities are expected to include enrollment of approximately 221 patients. BeyondSpring expects the transaction to substantially reduce its cash requirements for DUBLIN-4 while supporting efficient enrollment and the generation of China clinical data for the global trial.

“We believe the FDA Fast Track designation, an FDA-aligned global Phase 3 strategy, and funding to support China-generated clinical data would meaningfully strengthen our ability to advance Plinabulin and DUBLIN-4 toward the trial’s next major clinical milestone—the prespecified interim analysis at 221 PFS events,” said Min Qiu, CEO of BeyondSpring. “Fast Track designation underscores the significant unmet medical need for the DUBLIN-4 patient population in NSCLC patients whose disease has progressed following ICI and without AGAs, with limited options and docetaxel as the standard of care. Importantly, the strategic transaction provides a time- and capital-efficient approach to executing our global Phase 3 clinical strategy. Positive results from the interim analysis could represent a meaningful value inflection point for BeyondSpring.”

FDA Fast Track Designation

FDA Fast Track designation is designed to facilitate development and expedite review of therapies intended to treat serious conditions with unmet medical needs. The designation provides opportunities for more frequent interactions with the FDA regarding the development program and may allow for rolling review of a future regulatory application. Plinabulin may also be eligible for Priority Review if applicable criteria are met.

DUBLIN-4: Global Registrational Phase 3 Strategy

DUBLIN-4 is a randomized global Phase 3 trial evaluating Plinabulin plus docetaxel versus docetaxel alone in patients with advanced non-squamous NSCLC without actionable genomic alterations following progression on ICI and chemotherapy.

Approximately 442 patients are planned to be randomized 1:1, with overall survival (“OS”) as the primary endpoint and PFS and objective response rate (“ORR”) as secondary endpoints. The trial includes a prespecified interim analysis at 221 PFS events.

Approximately half of the planned trial population is expected to be enrolled at participating sites in China under the strategic arrangement, with the remainder expected to be enrolled through the broader global DUBLIN-4 program, including in the United States and other regions. BeyondSpring intends for data generated across participating regions to form part of an integrated global clinical dataset supporting its registration strategy for Plinabulin.

Strategic Arrangement Supports Global Phase 3 Execution

BeyondSpring has entered into a definitive agreement with Dalian Wanchunbulin Pharmaceuticals Ltd., the Company’s Chinese subsidiary (“Bulin”), and Biolin, pursuant to which BeyondSpring will sell BeyondSpring Ltd., its wholly owned subsidiary that indirectly holds the majority equity interest in Bulin, to Biolin.

Under the arrangement, Biolin will support the funding of clinical development activities conducted by Bulin at participating sites in China, and BeyondSpring will receive access to clinical data generated from the China portion of DUBLIN-4. Patients enrolled in China are expected to represent approximately half of the planned 442-patient global enrollment. Biolin’s obligation to support the funding of the China portion of DUBLIN-4, and to cause Bulin to conduct and use commercially reasonable efforts to complete the trial and perform certain related activities, will constitute the non-cash consideration for the sale of BeyondSpring Ltd.

Following the transaction, BeyondSpring will retain global rights to Plinabulin outside Greater China. The arrangement is expected to substantially reduce BeyondSpring’s cash requirements associated with DUBLIN-4, while China’s large eligible NSCLC patient population is expected to support efficient enrollment.

Conference Call and Webcast Information

BeyondSpring’s management will host a conference call and webcast today at 8:00 a.m. Eastern Time to discuss the announcement. The dial-in numbers are 1-877-737-7051 (U.S.) or 1-201-689-8878 (international). The live webcast will be available here. An archived replay of the webcast will be available following the presentation on BeyondSpring’s website www.beyondspringpharma.com under “Events” in the Investor section.

About Plinabulin and the Clinical Rationale for DUBLIN-4 Trial

Plinabulin is a late-stage, first-in-class investigational GEF-H1 agonist with a differentiated mechanism of action that includes dendritic cell maturation, anti-angiogenic activity and mitigation of chemotherapy-induced neutropenia. To date, more than 700 cancer patients have been treated with Plinabulin across multiple clinical programs in various cancer types, demonstrating an extensive clinical safety database.

The post-ICI setting remains difficult to treat, with 12 Phase 3 trials evaluating different treatment approaches against docetaxel, including four involving ADCs, having failed to demonstrate an overall survival benefit over docetaxel.

In the Phase 3 DUBLIN-3 Trial, published in The Lancet Respiratory Medicine in 2024, Plinabulin combined with docetaxel demonstrated a statistically significant improvement in OS in second- and third-line EGFR wild-type NSCLC vs. docetaxel alone (n=559), showing superior OS benefit in non-squamous patients (n=332, OS HR 0.72, p=0.0078). The combination also demonstrated statistically significant improvements compared to docetaxel alone, including doubling 2-year and 3-year survival rates and improvements in PFS and ORR, while also significantly reducing grade 4 neutropenia (p<0.0001).

Importantly, a post hoc analysis of the DUBLIN-3 post-ICI subgroup showed a median OS of 15.8 months with Plinabulin plus docetaxel versus 11.7 months with docetaxel alone (HR 0.55), with ORR of 18.2% versus 8.0%, respectively. These findings support the clinical rationale for Plinabulin’s differentiated dendritic cell maturation mechanism and its further evaluation in DUBLIN-4.

This rationale was further supported by prospective data from the Phase 2 Study 303 (n=47), presented at ASCO 2026. In patients with NSCLC whose disease had progressed following PD-1 inhibitor treatment, the combination of Plinabulin, docetaxel and a PD-1 inhibitor demonstrated encouraging anticancer activity. With a median follow-up of 28.8 months, the Plinabulin combination showed a median PFS of 7.0 months, a disease control rate of 79.5%, and a confirmed ORR of 18.2%, with a 2-year OS rate of 58%, nearly double the historical rate reported with docetaxel in a similar patient population.

About BeyondSpring

BeyondSpring (NASDAQ: BYSI) is a clinical-stage biopharmaceutical company developing first-in-class therapies for cancers with high unmet needs. Its lead asset, Plinabulin, has been studied in more than 700 cancer patients and is in late-stage development across multiple cancer indications. Plinabulin’s novel mechanism as a GEF-H1 agonist with dendritic cell maturation benefit supports both anticancer activity and immune modulation, offering a unique approach to resensitizing tumors that have progressed on checkpoint inhibitors. In addition, it has the potential to synergize with chemotherapy, antibody-drug conjugates (ADCs), radiation, and checkpoint inhibitors. BeyondSpring is also an early incubator of and maintains an equity interest in SEED Therapeutics, a clinical-stage targeted protein degradation molecular glue company with investments from Eli Lilly and Eisai. Learn more at beyondspringpharma.com.

Investor Contact: IR@beyondspringpharma.com
Media Contact: PR@beyondspringpharma.com

Cautionary Note Regarding Forward-Looking Statements

This press release includes forward-looking statements that are not historical facts. Words such as “will,” “expect,” “anticipate,” “plan,” “believe,” “design,” “may,” “future,” “estimate,” “predict,” “objective,” “goal,” or variations thereof and similar expressions are intended to identify such forward-looking statements. Forward-looking statements are based on BeyondSpring’s current knowledge, beliefs, and expectations regarding possible future events and are subject to risks, uncertainties, and assumptions. Actual results and the timing of events could differ materially from those anticipated in these forward-looking statements as a result of a number of factors, including, but not limited to, the risk that the conditions to the closing of the transaction may not be satisfied or waived on the expected timeline or at all; the inability of Biolin and Bulin to perform their respective funding, clinical development, data generation and other obligations under the definitive agreement; delays or challenges in enrollment or execution of the China portion of DUBLIN-4; regulatory, data-transfer or human-genetic-resources requirements that may affect the transfer or use of China-generated clinical data; the inability of such data to support regulatory submissions outside Greater China; the possibility that the transaction may not achieve the anticipated financial, operational or strategic benefits; difficulties in raising the anticipated amount needed to finance the Company’s future operations on terms acceptable to the Company, if at all; unexpected results from preclinical studies or clinical trials; the possibility that preclinical results may not be predictive of clinical results; delays in, or failure to obtain, regulatory approvals; results that do not meet the Company’s expectations regarding the safety, efficacy, clinical utility, or regulatory pathway of the Company’s product candidates; increased competition in the market; the possibility that Fast Track designation may not result in a faster development or regulatory review process or otherwise provide the anticipated benefits, and the fact that such designation does not increase the likelihood of regulatory approval; the Company’s ability to meet the continued listing requirements of The Nasdaq Stock Market LLC; and other risks described in BeyondSpring’s most recent Form 10-K and subsequent filings with the U.S. Securities and Exchange Commission. All forward-looking statements made herein speak only as of the date of this release, and BeyondSpring undertakes no obligation to publicly update such forward-looking statements to reflect subsequent events or circumstances, except as otherwise required by law.

VANCOUVER, British Columbia, Sept. 29, 2026 (GLOBE NEWSWIRE) — Stallion Uranium Corp. (the “Company” or “Stallion”) (TSX-V: STUD; OTCQB: STLNF; FSE: B76) is pleased to announce the recommencement of diamond drilling at the Coyote target on its flagship Moonlite Project in the Athabasca Basin, Saskatchewan, part of the southwestern Athabasca Basin Joint Venture (“JV”) with Atha Energy Corp. (“Atha Energy”) (TSX-V: SASK).

Matthew Schwab, CEO of Stallion Uranium, said, “Getting the drills turning again at Coyote allows us to immediately build on everything we learned during the first phase of the program. We now have a significantly stronger understanding of the geology, structure and radiometric response of the system, and that knowledge has directly influenced our Phase II targeting.

“With approximately 2,165 metres remaining, our focus is straightforward: deploy those metres into the highest-priority areas identified by our technical team. We believe the integration of drilling, geophysics and structural interpretation has given us our clearest picture of Coyote to date and provides a strong foundation for this next phase of drilling.”

Drilling crews have remobilized to Coyote to begin Phase II of Stallion’s expanded 2026 drilling campaign. The Company has completed approximately 4,585 metres of the planned 6,750-metre program, leaving approximately 2,165 metres of drilling to be completed during the current phase.

Phase II will build directly on the geological, structural and radiometric information generated during the first phase of drilling and will continue testing priority areas along the Coyote corridor.

Phase II Drilling:

The 2026 program represents the first systematic drill testing of the Coyote target and has provided Stallion with a significantly improved understanding of the geology and structural architecture underlying the corridor.

SRK Consulting has completed a regional-scale Structural Interpretation and Targeting Assessment designed to identify the primary and secondary structural controls associated with uranium mineralization in the western Athabasca Basin. The assessment provides Stallion with an additional framework for interpreting potential structural conduits and traps at Coyote and has been incorporated into the Company’s Phase II targeting.

Information collected from drilling completed to date has been integrated with Stallion’s geological interpretation, structural analysis and expanding geophysical dataset to refine the Company’s Phase II drill targets. The remaining approximately 2,165 metres of drilling will focus on the highest-priority areas identified through this integrated targeting approach.

Figure 1: Current drilling progress at the Moonlite Project

Stallion intends to use the remaining 2026 drilling to continue evaluating the geological and structural controls encountered during the program while testing additional high-priority positions within the Coyote system.

Advancing Coyote Through an Expanding Dataset:

Stallion began 2026 with an initial 4,000-metre drilling program at Coyote. As drilling progressed and additional geological and geophysical information became available, the program was first expanded to 5,500 metres and subsequently to approximately 6,750 metres.

Rather than simply adding metres to the original drill plan, the expanded program has allowed Stallion’s technical team to continuously refine subsequent drill locations as new information has been generated.

The commencement of Phase II represents the next stage of that process, with the remaining holes incorporating the Company’s most complete geological and geophysical interpretation of Coyote to date.

Figure 2: Priority target areas identified across the Moonlite Project

Importantly, the knowledge developed through drilling at Coyote is also contributing to Stallion’s evaluation and prioritization of additional target areas across the broader Moonlite Project.

2026 Moonlite Program – Next Steps:

With drilling now recommenced, Stallion’s near-term activities at Moonlite will focus on:

• Completing approximately 2,165 metres of additional drilling as part of the expanded 6,750-metre 2026 Coyote program;
• Testing refined Phase II targets developed from the integration of drilling, geological interpretation and geophysical datasets;
• Continuing geological logging, downhole gamma probing, sampling and interpretation of drill core from the 2026 program;
• Incorporating new Phase II results into the evolving geological and structural model for Coyote; and

The Company will provide additional updates as Phase II drilling progresses and results become available.

Gamma Logging and Geochemical Assaying:

All core radioactivity is measured using an RS-125 Super-SPEC Handheld Gamma-Ray Spectrometer. Downhole radiometric surveying is conducted using a Mount Sopris QL40GR-1000 downhole total gamma probe.

Drill core samples from the 2026 program are shipped to the Saskatchewan Research Council Geoanalytical Laboratories (“SRC”) in Saskatoon, Saskatchewan, an ISO/IEC 17025 accredited analytical laboratory. Stallion requests multi-element analysis by ICP-MS and ICP-OES using total and partial digestion, with boron analyzed by fusion. One half of the split core is retained and the other half is submitted to SRC for analysis.

Blanks, standard reference materials and repeats are inserted into the sample stream at regular intervals by Stallion Uranium geologists and SRC in accordance with industry-standard quality assurance/quality control (“QA/QC”) procedures.

The reader is cautioned that gamma probe readings are not directly or uniformly related to uranium grades of the rock measured and should be used only as a preliminary indication of the presence of radioactive materials.

Upcoming Events:

On Saturday, October 17, at 11:45 a.m. MDT, CEO Matthew Schwab will present at the Schachter Catch the Energy Conference in Calgary, Alberta, providing an update on the Company’s 2026 exploration activities and discussing its ongoing exploration strategy. Further information can be found here.

Qualifying Statement:

The foregoing scientific and technical disclosures for Stallion Uranium have been reviewed and approved by Darren Slugoski, P.Geo., VP Exploration, a registered member of the Professional Engineers and Geoscientists of Saskatchewan. Mr. Slugoski is a Qualified Person as defined by National Instrument 43-101.

About Stallion Uranium Corp.:

Stallion Uranium is working to ‘Fuel the Future with Uranium’ through the exploration of roughly 1,700 sq/km in the Athabasca Basin, home to the largest high-grade uranium deposits in the world. The Company, with JV partner Atha Energy, holds a significant contiguous project in the western Athabasca Basin adjacent to multiple high-grade discovery zones. With a commitment to responsible exploration and cutting-edge technology such as the use of the proprietary Haystack TI technology, Stallion is positioned to play a key role in the future of clean energy.

Our leadership and advisory teams are comprised of uranium and precious metals exploration experts with the capital markets experience and the technical talent for acquiring and exploring early-stage properties. For more information visit stallionuranium.com.

On Behalf of the Board of Stallion Uranium Corp.:

Matthew Schwab
CEO and Director

Corporate Office:
700 – 838 West Hastings Street,
Vancouver, British Columbia,
V6C 0A6

T: 604-551-2360
info@stallionuranium.com

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

This news release contains forward-looking statements and forward-looking information within the meaning of Canadian securities legislation (collectively, “forward-looking statements”) that relate to the Company’s current expectations and views of future events. Any statements that express, or involve discussions as to, expectations, beliefs, plans, objectives, assumptions or future events or performance (often, but not always, through the use of words or phrases such as “will likely result”, “are expected to”, “expects”, “will continue”, “is anticipated”, “anticipates”, “believes”, “estimated”, “intends”, “plans”, “forecast”, “projection”, “strategy”, “objective” and “outlook”) are not historical facts and may be forward-looking statements and may involve estimates, assumptions and uncertainties which could cause actual results or outcomes to differ materially from those expressed in such forward-looking statements. No assurance can be given that these expectations will prove to be correct and such forward-looking statements included in this material change report should not be unduly relied upon. These statements speak only as of the date they are made.

Forward-looking statements are based on a number of assumptions and are subject to a number of risks and uncertainties, many of which are beyond the Company’s control, which could cause actual results and events to differ materially from those that are disclosed in or implied by such forward-looking statements. The Company undertakes no obligation to update or revise any forward-looking statements, whether as a result of new information, future events or otherwise, except as may be required by law. New factors emerge from time to time, and it is not possible for the Company to predict all of them or assess the impact of each such factor or the extent to which any factor, or combination of factors, may cause results to differ materially from those contained in any forward-looking statement. Any forward-looking statements contained in this presentation are expressly qualified in their entirety by this cautionary statement.

Photos accompanying this announcement are available at

https://www.globenewswire.com/NewsRoom/AttachmentNg/432526aa-b950-4eaa-b442-d51dda5d7863

https://www.globenewswire.com/NewsRoom/AttachmentNg/9127718a-1e31-4f8a-a093-d72ff9a2d394

Estimates secured in due diligence provided information of 2.9 million barrels of oil reserves plus an estimated $100 million in natural gas to be utilized for Alpha Compute’s Data Center with over 200 MW of behind-the-meter power generation

Pittsburgh, PA, Sept. 29, 2026 (GLOBE NEWSWIRE) — Alpha Compute Corp. (Nasdaq: ALP) (“Alpha Compute” or the “Company”), a vertically integrated technology pioneer in Sovereign Intelligence, Confidential Compute and GPU-as-a-service (GPUaaS), today announced an update on the Alpha Energy 02 transaction, first announced on September 22, 2026 with a total purchase price is USD $5.5 million.

Last week, Alpha Compute’s oil, gas, and minerals leadership visited the property to review additional due diligence documents, met with the sellers/managers, and toured the pad sites. Information on the operations, financials,  on-site verification of well resources, and equipment inventory were obtained and completed. 

Evaluation of log files from one natural gas test well into the Marcellus shale indicates substantial recoverable gas resources across multiple formations linked to the acquired land and mineral rights. Supplemented by potential unconstrained production-type curves from adjacent analog wells of two producing shallow gas wells, these reserves correspond to an estimated 200 MW of power generation capacity dedicated to Alpha Compute data center planned for Q1 2028. Beyond providing on-site, behind-the-meter power for planned data center developments, the transaction encompasses over 75 active oil wells with an estimated 2.9 million barrels of remaining oil-in-place.

Update On Assets

The acquisition delivers a stacked-resource position on more than 300 acres of surface, mineral and gas rights spanning both the Marcellus and Utica shale formations. The assets include:

• One natural gas test-well with proven natural gas reserves;
• More than 75 existing, producing oil and shallow gas wells with complete pump jack inventories;
• Operational maintenance facilities, heavy equipment and associated gathering infrastructure; and
• Full surface control, enabling co-location of power generation and compute on the same parcel.

Oil in Place and Illustrative Asset Value

Historical documentation and test-well logs obtained in due diligence from an assessment estimates approximately 10,000 barrels per acre of light Pennsylvania-grade sweet crude oil across the subsurface parcels, implying roughly 3.0 million barrels of original oil in place across the acquired acreage. Preliminary evaluations indicate that only an estimated 4% of that volume has been extracted to date, leaving approximately 2.9 million barrels of oil in place.

For context, at prevailing West Texas Intermediate prices of roughly $90 per barrel in late September 2026, the remaining in-place volume carries an illustrative gross, undiscounted value on the order of $260 million. 

Based on standard primary-recovery rates of 5% to 15% for shallow Appalachian crude, estimated recoverable reserves range from 145,000 to 435,000 barrels. At current market rates, this projects to roughly $13 million to $39.1 million in gross top-line revenue, prior to royalties, taxes, and operational expenses. Backed by more than One decades of documented financial history, the current wells remain active and cash-flow positive today. A planned workover capital expenditure of approximately $3.5 million is projected to restore field output to these higher historical rates. 

Marcellus and Utica Gas Potential

One test-well is the near-term catalyst. Horizontal wells completed in the Pennsylvania Marcellus and Utica typically recover on the order of 10 to 20 billion cubic feet (Bcf) of natural gas each over their producing lives, implying combined estimated ultimate recovery of approximately 20 to 40 Bcf for the One wells, depending on lateral length, completion design and reservoir quality. Bringing both wells online is expected to cost approximately $10 million to $12 million per well.

At an illustrative realized price of $2.00 to $2.50 per MMBtu, reflecting Henry Hub pricing of roughly $3.00 less Appalachian basis differentials, the One wells alone represent approximately $40 million to $100 million of gross lifetime gas revenue if sold to market. Across the full 300-acre block, the stacked Marcellus and Utica formations are estimated to hold roughly 50 to 70 Bcf of recoverable gas, supporting additional drilling locations beyond the One existing wells.

Alpha Compute does not intend to simply sell this gas. Consumed on site through simple-cycle generation at approximately 7.5 MMBtu per megawatt-hour, initial combined production of 20 to 40 million cubic feet per day from the One wells could support roughly 100 to 200 MW of generation capacity at first production, with the combined 20 to 40 Bcf of recoverable gas sufficient to sustain approximately 30 to 60 MW of continuous load for a decade. This converts a commodity exposed to Appalachian basis discounts into low-cost, dispatchable power for AI compute.

“We paid $5.5 million for an operating business that produces oil and cash flow today, and that sits on roughly 2.9 million barrels of oil in place and one gas well ready to complete,” said Enzo Villani, Executive Chairman and President of Alpha Compute Corp. “Our updated geological work, modern appraisals and third-party reserve engineering are underway, and we expect them to support a substantial revaluation of these assets on our balance sheet. In the meantime, the site pays for itself.”

“This acquisition gives Alpha Compute something few AI infrastructure companies have: the fuel, the land and the compute on a single asset,” said Brittany Kaiser, CEO of Alpha Compute Corp. “With one well already drilled. Completing them is the fastest path in Pennsylvania to behind-the-meter power for our next data center, and we will do it under Pennsylvania DEP oversight, in partnership with the county and with the local community at the forefront of our plans.”

Next Steps

• Complete updated geological assessments, modern appraisals and independent reserve engineering to map recoverable oil and gas volumes;
• Advance DEP permitting and contracting for the hydraulic fracturing and completion of the One gas wells;
• Finalize the design of on-site generation and the planned data center, replicating the community-first framework developed for Alpha Compute’s Northern Pennsylvania site; and
• Enter binding covenants with local and county governments aligned with municipal development goals.

Facility Design and Environmental Compliance

Development will comply fully with local county ordinances and land-use regulations, regional grid policies and interconnection standards, and Pennsylvania Department of Environmental Protection (DEP) regulations, including applicable operator registration, bonding and well-plugging requirements.

Community Partnership and Economic Impact

• Job Creation: Projected creation of skilled permanent and construction positions;
• Infrastructure Investment: Modernization of site utilities and sustainable integration with local energy grid capacity;
• Environmental Stewardship: Post-closing environmental compliance, plugging assurances and responsible well management under DEP oversight.

Summary of Illustrative Estimates

Metric	Basis	Illustrative Estimate
Original oil in place (historical Halliburton assessment)	~10,000 bbl/acre × ~300 acres	~3.0 million barrels
Oil extracted to date (preliminary)	~4% of estimated in-place volume	~120,000 barrels
Remaining oil in place	In-place, not recovered volume	~2.9 million barrels
Illustrative gross value of remaining oil in place	WTI ~$90/bbl (late Sept. 2026); Penn Grade crude priced near WTI	~$260 million (undiscounted, in-place)
Illustrative recoverable oil (primary recovery)	5-15% of remaining in-place volume	~145,000–435,000 barrels (~$13M–$39.1M gross at ~$90/bbl)
One test-drilled, uncompleted gas wells – estimated ultimate recovery	Typical PA Marcellus/Utica horizontal well: ~10–20 Bcf each	~20–40 Bcf combined
Illustrative gross gas revenue, One wells (life of well)	Realized ~$2.00–$2.50/MMBtu (Henry Hub ~$3.00 less Appalachian basis)	~$40M–$100M (undiscounted)
Estimated completion cost to bring the one well online	Industry range for Appalachian horizontal completions	~$10M–$12M per well
Behind-the-meter generation potential, One test well	Initial ~20–40 MMcf/d combined; ~7.5 MMBtu per MWh simple-cycle	~100–200 MW initially; ~30–60 MW sustained over 10 years Plus access to major gas lines on property.
Recoverable gas across the ~300-acre block (both formations)	~0.08–0.12 Bcf/acre per formation, Marcellus + Utica	~50–70 Bcf

All figures above are illustrative, order-of-magnitude estimates prepared by the Company from historical third-party documentation, publicly available basin-level type curves and prevailing commodity prices as of late September 2026. They are not estimates of proved, probable or possible reserves as defined by the U.S. Securities and Exchange Commission, have not been prepared or reviewed by an independent petroleum engineer, are undiscounted, and are stated before royalties, operating costs, capital costs and taxes. Actual results will depend on completed reserve engineering, well performance, commodity prices, permitting and financing. See “Forward-Looking Statements.”

About Alpha Compute Corp.

Alpha Compute Corp. (Nasdaq: ALP) is a vertically integrated AI infrastructure company specializing in GPU-as-a-service and AI Confidential Compute. Alpha Compute’s mission is to support clients, subsidiaries, and partners across critical sectors including: finance, defense, intelligence, and media with the essential framework for any organization requiring secure, confidential computing environments. 

Alpha Compute Corp is domiciled in the British Virgin Islands with offices in New York, Los Angeles, Miami, Amsterdam and Toronto. Alpha Compute is a founding partner of the Right2Compute Coalition.

Forward-Looking Statements

This press release contains forward-looking statements within the meaning of applicable securities laws. All statements other than statements of historical fact, including those preceded by, followed by, or incorporating words such as “believes,” “expects,” “anticipates,” “intends,” “estimates,” “plans,” “may,” “will,” “potential,” “continues,” or similar expressions are forward-looking statements.

Forward-looking statements in this release include, without limitation: estimates of oil and gas in place, recoverable volumes, estimated ultimate recovery, completion costs, commodity prices, realized prices, gross revenue and generation capacity; the anticipated revaluation of the acquired assets; the completion and performance of the one drilled gas wells; title, acreage and net revenue interest; the development, permitting, financing, construction and commercial operation of on-site generation and the planned data center; and potential economic, environmental and community impacts.

These statements involve known and unknown risks and uncertainties that may cause actual results to differ materially from those expressed or implied, including: the results of updated geological assessments, appraisals and independent reserve engineering; well performance and recovery factors; volatility in oil and natural gas prices and Appalachian basis differentials; permitting, environmental and well-plugging risks; the timing and progress of the Company’s strategic initiatives; reliance on third-party vendors and partners; the ability to secure additional financing; uncertainty around the Company’s investments and legacy business; risks related to technology platforms and ecosystems; and general market and economic conditions. A more complete discussion of these risks is set forth under “Item 3 – Key Information – Risk Factors” in the Company’s Annual Report on Form 20-F for the year ended March 31, 2026, as amended.

Undue reliance should not be placed on these forward-looking statements. The forward-looking statements contained herein are made as of the date of this press release, and the Company undertakes no obligation to update or revise them publicly, except as required by law.

Investor & Media Contact

Alpha Compute Corp.
ir@alphacompute.ai
www.alphacompute.ai

CONTACT: ir(at)alphacompute.ai