Tag: GlobeNewswire

• Initiated a Phase 1/2 clinical trial to enroll healthy volunteers and patients with Urea Cycle Disorders of any mutational background 
• Administered a single dose of 2mg/kg to the first cohort of healthy volunteers
• Expected to start dosing in UCD patients in the first half of 2027 with an interim readout expected in the second half of 2027

CAMBRIDGE, Mass., Oct. 05, 2026 (GLOBE NEWSWIRE) — Korro Bio, Inc. (Korro) (Nasdaq: KRRO), a clinical-stage biopharmaceutical company leveraging its oligonucleotide promoted editing of RNA (OPERA^®) platform to develop a new class of genetic medicines for rare and highly prevalent diseases, announced today that the first cohort of participants has been dosed in its Phase 1/2 clinical trial for KRRO-121, the Company’s GalNAc-conjugated RNA-editing oligonucleotide (REO) in development for the potential treatment of hyperammonemia in patients with urea cycle disorders (UCDs) and patients with hepatic encephalopathy (HE).

“UCD patients and their families live with a constant, low-grade fear that a stomach bug, a skipped dose of a nitrogen scavenger or just the wrong meal could trigger a hyperammonemic crisis. In multiple preclinical studies with different mutations, KRRO-121 has demonstrated the ability to blunt ammonia excursions,” said Ram Aiyar, PhD, Chief Executive Officer and President of Korro. “Dosing the first cohort in ANCHOR is a step towards gaining evidence on safety first and then activity. Providing the potential for peace of mind for patients with a UCD, irrespective of their mutational background, is something we hope to demonstrate through this trial. I would like to thank all the stakeholders involved in making this possible and working with us to provide options for patients living with UCD.”

This trial is currently enrolling healthy volunteers in Australia and is part of a global Phase 1/2 clinical trial program entitled ANCHOR (AssessmeNt of Control of Hyperammonemia through Oligonucleotide-based RNA editing). ANCHOR consists of two components:

1. Part 1: Comprises a Phase 1 single ascending dose (SAD) study to be followed by a multiple ascending dose (MAD) study of KRRO-121 and placebo in healthy volunteers to evaluate safety, tolerability and pharmacokinetics (PK) in up to 50 participants; and
    
2. Part 2: Comprises a Phase 2 multiple dose study of KRRO-121 in up to 15 participants with UCD across all UCD genotypes to assess safety, tolerability, PK and clinical activity subject to regulatory approval

The SAD part of Korro’s Phase 1 clinical trial will enroll up to 30 healthy volunteers in up to five cohorts, with the MAD portion enrolling up to 20 subjects across two cohorts. Both the SAD and the MAD portions will be placebo controlled (www.clinicaltrials.gov (NCT07773246)).

About Korro

Korro is a clinical-stage biopharmaceutical company leveraging a novel oligonucleotide promoted editing of RNA (OPERA^®) platform to develop a new class of genetic medicines for rare and highly prevalent diseases. OPERA provides precise, tissue-directed delivery of RNA-editing oligonucleotides (REOs) that modify the targeted native mRNA transcript to repair or form a de novo protein with enhanced functionality. The platform combines a suite of capabilities consisting of sophisticated knowledge of transcription biology through ADAR proteins (Adenosine Deaminases Acting on RNA), machine learning optimization of REOs, linker chemistry expertise, along with use of a highly targeted tissue-specific delivery methodology. As such, the OPERA platform has enabled Korro to generate and advance a portfolio of differentiated programs that are designed to harness the body’s natural RNA editing process, providing precise yet transient single base edits to produce therapeutic proteins with augmented activity versus its endogenous counterpart. By editing RNA instead of DNA, Korro is expanding the reach of genetic medicines by delivering additional precision and tunability, which has the potential for increased specificity and improved long-term tolerability. Using an REO-based approach, Korro expects to bring its medicines to patients by leveraging its proprietary OPERA platform with precedented delivery modalities, including N-acetylgalactosamine (GalNAc) conjugated for delivery for subcutaneous administration, manufacturing know-how and established regulatory pathways of approved oligonucleotide medicines. Korro is based in Cambridge, Massachusetts. For more information, visit korrobio.com.

Korro intends to use its Investor Relations website, LinkedIn and X (Twitter) as means of disclosing material nonpublic information and for complying with its disclosure obligations under Regulation FD. Accordingly, investors should monitor Korro’s Investor Relations website and follow @KorroBio on LinkedIn and X (Twitter), in addition to following Korro’s press releases, SEC filings, public conference calls, presentations and webcasts.

About ANCHOR

ANCHOR (AssessmeNt of Control of Hyperammonemia through Oligonucleotide-based RNA editing) is Korro’s global two-part Phase 1/2 clinical trial program evaluating the safety, tolerability, pharmacokinetics (PK) and clinical activity of KRRO-121. Part 1 will include Phase 1 single ascending dose (SAD) and Phase 1 multiple ascending dose (MAD) studies of KRRO-121 in healthy adult volunteers. Part 2 will be a Phase 2 trial in patients with UCDs.

Part 1 SAD, which started in September 2026, is enrolling up to 30 healthy volunteers across up to five cohorts, placebo-controlled at each dose level. Part 1 MAD will evaluate certain selected doses of KRRO-121 in up to 20 healthy volunteers across two cohorts. The primary goal of Part 1 is to evaluate safety, tolerability and PK of KRRO-121.

Part 2 of the ANCHOR program will evaluate KRRO-121 in patients with UCDs, evaluating safety, tolerability, PK and clinical activity. Dosing of UCD patients is expected to start in the first half of 2027, with an interim clinical readout expected in the second half of 2027. For additional information about the ANCHOR program, visit ClinicalTrials.gov (NCT07773246); the subsequent trials in the two-part ANCHOR program will be appended to ClinicalTrials.gov as those trials commence.

About Hyperammonemia

Hyperammonemia, the dangerous accumulation of ammonia in the blood, manifests across multiple indications, including urea cycle disorders (UCDs) and hepatic encephalopathy (HE). UCDs are rare inborn errors of metabolism involving deficiencies of enzymes required for ureagenesis, the process of converting ammonia to urea for excretion. The absence or deficiency of any of the urea cycle enzymes can result in hyperammonemia and an increased risk of hyperammonemic crises (HACs), which can result in severe and permanent neurological symptoms, coma and death. HE is a neuropsychiatric complication of liver disease characterized by cognitive dysfunction and altered consciousness. HE is primarily caused by the liver’s inability to adequately detoxify ammonia, typically occurring in patients with liver cirrhosis. This leads to ammonia accumulating in the bloodstream and crossing the blood-brain barrier, causing brain dysfunction that ranges from subtle cognitive impairment to severe confusion and coma.

About KRRO-121

KRRO-121 is a GalNAc-conjugated RNA-editing oligonucleotide for the potential treatment of hyperammonemia in patients with UCDs of any mutational background as well as patients with HE. Utilizing Korro’s proprietary OPERA^® platform, KRRO-121 is designed to generate a stabilized, de novo glutamine synthetase (GS) protein, a critical enzyme involved in ammonia clearance. This synthetic rescue approach is designed to augment ammonia clearance in hyperammonemia-driven diseases such as UCDs and HE. Korro’s preclinical data support the potential for KRRO-121 to be a pan-UCD treatment that may control ammonia levels, along with the potential to enable diet liberalization, reduce dependence on nitrogen scavengers and lower the risk of HACs. KRRO-121 also has the potential to enhance ammonia control in HE patients, which may reduce the risk of recurrent HE episodes. KRRO-121 may offer infrequent subcutaneous dosing, which, if confirmed in clinical studies, could offer significant improvement over current treatments that require multiple daily doses. KRRO-121 has the potential to be a differentiated, first-in-class, disease-modifying therapy for both UCD and HE.

Forward-Looking Statements

Certain statements in this press release may constitute “forward-looking statements” within the meaning of the Private Securities Litigation Reform Act of 1995, as amended. Forward-looking statements include, but are not limited to, express or implied statements regarding expectations, hopes, beliefs, intentions or strategies of Korro regarding the future including, without limitation, express or implied statements regarding: the design, conduct, enrollment and progression of the ANCHOR Phase 1/2 clinical trial program, including the timing of results from ANCHOR; the potential of, and market opportunity for, KRRO-121; the extent to which preclinical findings for KRRO-121 translate into clinical results; the therapeutic potential of the OPERA platform; Korro’s ability to provide additional treatment options for, and improve outcomes for, patients living with UCDs; reaching clinical milestones across multiple programs; among others. In addition, any statements that refer to projections, forecasts or other characterizations of future events or circumstances, including any underlying assumptions, are forward-looking statements. The words “anticipate,” “believe,” “continue,” “could,” “estimate,” “expect,” “intend,” “may,” “might,” “plan,” “possible,” “potential,” “predict,” “project,” “should,” “strive,” “would,” “aim,” “target,” “commit” and similar expressions may identify forward-looking statements, but the absence of these words does not mean that statement is not forward looking. Forward-looking statements are based on current expectations and assumptions that, while considered reasonable, are inherently uncertain. New risks and uncertainties may emerge from time to time, and it is not possible to predict all risks and uncertainties. Factors that may cause actual results to differ materially from current expectations include, but are not limited to, various factors beyond management’s control including risks associated with preclinical studies and conducting clinical trials; risks associated with validating in clinical trials observations from preclinical studies; risks associated with collaborating with third parties; other risks associated with protecting intellectual property; as well as risks associated with general economic conditions; and other risks and uncertainties indicated from time to time in Korro’s filings with the Securities and Exchange Commission (SEC), including Part II Item 1A. “Risk Factors” in Korro’s Quarterly Report on Form 10-Q filed with the SEC on August 6, 2026, as such may be amended or supplemented by its other filings with the SEC. Nothing in this press release should be regarded as a representation by any person that the forward-looking statements set forth herein will be achieved or that any of the contemplated results of such forward-looking statements will be achieved. You should not place undue reliance on forward-looking statements in this press release, which speak only as of the date they are made and are qualified in their entirety by reference to the cautionary statements herein. Except as required by law, Korro does not undertake or accept any duty to release publicly any updates or revisions to any forward-looking statements to reflect any change in its expectations or in the events, conditions or circumstances on which any such statement is based. This press release does not purport to summarize all of the conditions, risks and other attributes of an investment in Korro.

Korro Bio Contact Information 

Investor & Media Contact 
Malini Chatterjee, PhD
Blueprint Life Science Group
mchatterjee@bplifescience.com or ir@korrobio.com
917.330.4269

On track to initiate dosing by early November 2026; topline Phase 1 proof-of-mechanism data anticipated approximately six months following study initiation

Randomized, double-blind, placebo-controlled study will evaluate safety, tolerability, pharmacokinetics and pharmacodynamics of EQ504 in healthy subjects

LA JOLLA, Calif., Oct. 05, 2026 (GLOBE NEWSWIRE) — Equillium, Inc. (Nasdaq: EQ), a biotechnology innovator developing novel therapies to treat severe autoimmune and inflammatory disorders, today announced that the Company has received Human Research Ethics Committee (HREC) approval and clearance from the Therapeutic Goods Administration (TGA) in Australia under the Clinical Trial Notification (CTN) scheme for its Phase 1 clinical trial of EQ504. The Company expects to begin dosing healthy participants by early November 2026.

“We believe receiving Australian regulatory clearance is an important step in executing our development plan for EQ504 and keeps us on track to dose the first participant in the coming weeks,” said Bruce Steel, Chief Executive Officer of Equillium. “The Phase 1 trial is designed to evaluate safety and tolerability, as well as characterize EQ504’s pharmacokinetic and pharmacodynamic profile to assess proof of mechanism. Subject to supportive Phase 1 data, we anticipate initiating a placebo-controlled proof-of-concept study in patients with moderately to severely active ulcerative colitis in the second half of 2027.”

As a potent and selective AhR modulator, EQ504 can affect both immune cell responses and barrier restoration. Together, these attributes are particularly important in diseases such as ulcerative colitis, where reducing inflammation and improving and maintaining mucosal healing are critical to achieving meaningful outcomes for patients.

About the Phase 1 Trial

The Phase 1 trial is a randomized, double-blinded, placebo-controlled, single-center study designed to evaluate the safety, tolerability, pharmacokinetics (PK), and pharmacodynamics (PD) of EQ504 in healthy participants, exploring once-daily oral doses ranging from 0.1-3.0 mg. The trial is structured into three distinct parts:

• Part A – Single Ascending Dose (SAD): Evaluates escalating, once-daily oral doses of EQ504 across five (5) sequential cohorts of healthy participants to determine initial safety parameters and PK.
• Part B – Multiple Ascending Dose (MAD): Evaluates multiple escalating oral doses across three (3) cohorts, in healthy participants receiving once-daily dosing for ten (10) days to assess steady-state PK, safety, and cumulative tolerability. In addition to systemic plasma exposure and to validate the drug’s localized mechanism of action, the study protocol incorporates gastrointestinal (GI) mucosal biopsies to be collected longitudinally during the study. A primary pharmacodynamic focus of these biopsies will include the assessment of key tissue-specific biomarkers, including Cytochrome P450 1A1 (CYP1A1) expression. These mechanistic tissue data are designed to confirm localized biological activity and provide target validation ahead of the Phase 2 proof-of-concept study.
• Part C – Food Effect Cohort: A dedicated crossover cohort to evaluate the impact of a high-fat meal on the bioavailability and systemic exposure of a single oral dose of EQ504.

About EQ504
EQ504 is an investigational potent and selective aryl hydrocarbon receptor (AhR) modulator with a multi-modal, non-immunosuppressive mechanism of action designed to be complementary to other inflammation and immunology agents. AhR is critical to barrier organ tissue physiology and immunology, maintaining barrier function and promoting tissue repair and regeneration, while regulating resident immune cells with anti-inflammatory responses. For ulcerative colitis, EQ504 is formulated as an oral, colon-targeted delayed-release drug product. Equillium is also evaluating the potential of EQ504 for additional indications, including inflammatory lung diseases through inhaled formulations.

About Equillium
Equillium is a biotechnology innovator with a mission to develop highly impactful therapies to treat severe autoimmune and inflammatory disorders.

For more information, visit www.equilliumbio.com.

Forward Looking Statements
Statements contained in this press release regarding matters that are not historical facts are “forward-looking statements” within the meaning of the Private Securities Litigation Reform Act of 1995. Forward-looking statements may be identified by the use of words such as “anticipate”, “believe”, “could”, “continue”, “expect”, “estimate”, “may”, “plan”, “outlook”, “future”, “potential” and “project” and other similar expressions that predict or indicate future events or trends or that are not statements of historical matters. These statements include, but are not limited to, statements regarding Equillium’s plans and strategies with respect to developing EQ504, including the expected timeline for dosing healthy participants and patients; Equillium’s ability to initiate clinical studies and report data from any clinical studies which may be initiated, or the expected timeline for initiating any such studies or reporting data; the expected timeline for initiating and reporting data from a Phase 1 trial of EQ504; the potential benefits of EQ504; and the importance of the attributes of EQ504 in diseases such as ulcerative colitis. Because such statements are subject to risks and uncertainties, many of which are outside of Equillium’s control, actual results may differ materially from those expressed or implied by such forward-looking statements. Risks that contribute to the uncertain nature of the forward-looking statements include: Equillium’s ability to execute its plans and strategies; risks related to performing clinical and pre-clinical studies; whether the results from clinical and pre-clinical studies will validate and support the safety and efficacy of Equillium’s product candidates; changes in the competitive landscape; and Equillium’s ability to raise sufficient financing, which may not be available on acceptable terms or at all, to advance EQ504 and fund Equillium’s strategic plans. These and other risks and uncertainties are described more fully under the caption “Risk Factors” and elsewhere in Equillium’s filings and reports, which may be accessed for free by visiting the Securities and Exchange Commission’s website and on Equillium’s website under the heading “Investors.” Investors should take such risks into account and should not rely on forward-looking statements when making investment decisions. All forward-looking statements contained in this press release speak only as of the date on which they were made. Equillium undertakes no obligation to update such statements to reflect events that occur or circumstances that exist after the date on which they were made, except as required by law.

Investor Contact
PJ Kelleher
LifeSci Advisors, LLC
+1-617-430-7579
pkelleher@lifesciadvisors.com

TOKYO, Oct. 05, 2026 (GLOBE NEWSWIRE) — CTW (Nasdaq: CTW) (“CTW” or “the Company”), a leading game platform company providing global access to web-based games through its flagship HTML5 platform, G123.jp, today announced that it will release its financial results for the six months and fiscal year ended July 31, 2026 after market close on Thursday, October 15, 2026.

Management will also host an earnings webinar at 8:30am ET on Friday, October 16, 2026, to review the financial results and provide a general corporate update. Investors can register for the webinar here.

About CTW

CTW is a leading game platform company providing global access to web-based, free-to-play games inspired by popular Japanese anime IP, including So I’m a Spider, So What? Ruler of the Labyrinth, Arifureta: From Commonplace to World’s Strongest – Rebellion Soul, and Queen’s Blade Limit Break. CTW delivers these games through its globally accessible flagship platform, G123.jp, which has accumulated paying users in over 180 countries since its 2018 launch. Founded in Tokyo in 2013, CTW partners with anime and manga IP holders to bring officially licensed titles to players around the world with no downloads or account registration required.

For more information, visit www.ctw.inc or G123.jp.

Safe Harbor Statement

This announcement contains forward-looking statements within the meaning of Section 21E of the U.S. Securities Exchange Act of 1934, as amended. These forward-looking statements are made under the “safe harbor” provisions of the U.S. Private Securities Litigation Reform Act of 1995. These statements can be identified by terminology such as “will,” “expects,” “anticipates,” “future,” “intends,” “plans,” “believes,” “estimates,” “potential,” “continue,” “ongoing,” “targets,” “guidance” and similar statements. CTW may also make written or oral forward-looking statements in its periodic reports to the SEC, in its annual report to shareholders, in press releases and other written materials and in oral statements made by its officers, directors or employees to third parties. Any statements that are not historical facts, including statements about CTW’s beliefs and expectations, are forward-looking statements. Forward-looking statements involve inherent risks and uncertainties. A number of factors could cause actual results to differ materially from those contained in any forward-looking statement, including but not limited to the following: CTW’s growth strategies; its future business development, results of operations and financial condition; its ability to distribute successful and engaging games with high “playability” on its platform; its ability to efficiently attract and retain end-users who come to play and make in-game purchases; its ability to achieve positive return on investment on user acquisition efforts; its ability to establish and maintain relationships with game developers; governmental policies and regulations relating to CTW’s industry; and general economic and business conditions globally and in Japan and assumptions underlying or related to any of the foregoing. Further information regarding these and other risks, uncertainties or factors is included in CTW’s filings with the SEC. All information provided in this press release and in the attachments is as of the date of this press release, and CTW undertakes no obligation to update any forward-looking statement, except as required under applicable law.

Contacts

Media Contact:
CTW Press Team
corpcomm@ctw.inc 

Investor Relations Contact:
Patrick Federle | Head of Investor Relations
investor@ctw.inc 

Company remains focused on maximizing shareholder value and evaluating credible strategic opportunities

GARDENA, Calif., Oct. 05, 2026 (GLOBE NEWSWIRE) — Polar Power, Inc. (NASDAQ: POLA) (the “Company”), a global provider of prime, backup and solar hybrid power solutions, today announced that its Board of Directors has rejected an all-cash proposal from Solidion to acquire all of the Company’s assets.

The Company received Solidion’s offer last week. Following a review, the Board determined that the proposal materially and substantially undervalues Polar Power’s assets, intellectual property, existing business opportunities and the significant growth opportunities the Company believes lie ahead.

The Board and management team remain firmly committed to maximizing value for Polar Power shareholders and will actively evaluate credible strategic opportunities that may advance that objective, including mergers, acquisitions, business combinations, joint ventures, strategic investments and other transactions designed to unlock and enhance shareholder value.

“Polar Power has spent decades developing valuable technology, intellectual property and operating capabilities that we believe position the Company for significant opportunities across our existing and emerging markets,” said Arthur Sams, Chief Executive Officer of Polar Power. “The Board determined that Solidion’s proposal does not come close to reflecting the value of those assets or the future opportunities we see for the Company. Our focus is on maximizing value for our shareholders, and we remain open to evaluating credible strategic transactions that we believe can deliver superior value.”

Polar Power will continue to pursue its existing business strategy while remaining open to strategic alternatives that the Board believes could enhance long-term shareholder value.

About Polar Power, Inc.

Polar Power, Inc. (NASDAQ: POLA) designs, manufactures and sells direct-current power systems and related technologies for telecommunications, data centers, defense, EV charging, microgrids and other distributed power markets. The Company is headquartered in Gardena, California.

Forward-Looking Statements

This press release contains forward-looking statements regarding, among other matters, the Company’s business opportunities, growth prospects, strategic alternatives and efforts to maximize shareholder value. These statements are subject to risks and uncertainties that could cause actual results to differ materially, including risks described in the Company’s filings with the Securities and Exchange Commission. Polar Power undertakes no obligation to update forward-looking statements except as required by law.

Media and Investor Relations
Polar Power, Inc.
249 E. Gardena Blvd.
Gardena, CA 90248
Tel: 310-830-9153
Email: ir@polarpowerinc.com
www.polarpower.com

IRVINE, Calif., Oct. 05, 2026 (GLOBE NEWSWIRE) — Eledon Pharmaceuticals, Inc. (“Eledon”) (Nasdaq: ELDN) today announced an oral presentation will be featured at the upcoming American Society of Nephrology Kidney Week 2026 Annual Meeting taking place in Denver, CO, from October 21-25, 2026. The oral presentation will highlight patient-reported outcomes from the Phase 2 BESTOW trial evaluating tegoprubart for the prevention of rejection in kidney transplantation.

Details of the presentation are below:

Title: Patient-Reported Outcomes in the Phase 2 BESTOW Trial Comparing Tegoprubart to Tacrolimus in Kidney Transplant Recipients

Presenter: Andrew B. Adams, M.D., Ph.D., Department of Surgery, University of Minnesota Medical School; Minneapolis, Minnesota

Abstract Publication Number: FR-OR084

Session Title: The Changing Landscape of Kidney Transplantation: Clinical Innovation, Outcomes, and Healthy Policy

Session Date and Time: Friday, October 23, 2026, from 4:30PM to 6:00PM MDT

Session Room: Mile High Ballroom 4A (Convention Center)

Presentation Time: 4:40PM to 4:50 PM MDT

About Eledon Pharmaceuticals and tegoprubart

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

Follow Eledon Pharmaceuticals on social media: LinkedIn; X

Investor Contact:

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

Media Contact:

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

BOCA RATON, FL, Oct. 05, 2026 (GLOBE NEWSWIRE) — DeFi Development Corp. (Nasdaq: DFDV) (the “Company”), the first U.S. public company with a treasury strategy built around accumulating and compounding Solana (SOL), today announced it will host its August & September 2026 Recap & Ask Me Anything (“AMA”) on Tuesday, October 6, 2026, at 12:00 p.m. ET via X Spaces.

The event will provide shareholders, analysts, and the broader community with a comprehensive review of DFDV’s progress during August and September, including updates on SOL treasury growth, capital markets activity, the launch of CHAD, ecosystem partnerships, and broader developments across the Solana ecosystem. Members of the Company’s leadership team will also discuss recent Company developments and answer live questions from retail investors and the broader community.

Participants can join the live event through the link below. A recording of the conversation will be made available shortly after the event concludes.

Join the conversation: https://x.com/i/spaces/1OGwbnaAgLWKB?s=20. 

About DeFi Development Corp.
DeFi Development Corp. (Nasdaq: DFDV) has adopted a treasury policy under which the principal holding in its treasury reserve is allocated to SOL. Through this strategy, the Company provides investors with direct economic exposure to SOL, while also actively participating in the growth of the Solana ecosystem. In addition to holding and staking SOL, DeFi Development Corp. operates its own validator infrastructure, generating staking rewards and fees from delegated stake. The Company is also engaged across decentralized finance (DeFi) opportunities and continues to explore innovative ways to support and benefit from Solana’s expanding application layer.

The Company is also an AI-powered online platform that connects the commercial real estate industry by providing value-add services and software subscriptions to multifamily and commercial property professionals, as the Company connects the increasingly complex ecosystem that stakeholders have to manage. The Company’s data and software offerings are generally offered on a subscription basis as software as a service.

Investor Contact:
ir@defidevcorp.com

Media Contact:
press@defidevcorp.com

WALTHAM, Mass., Oct. 05, 2026 (GLOBE NEWSWIRE) — Spyre Therapeutics, Inc. (“Spyre” or the “Company”) (Nasdaq: SYRE), a clinical-stage biotechnology company committed to developing next-generation therapies that elevate the standard in immunology by delivering more complete disease control, greater durability, and a simpler treatment experience for patients, today announced that it has commenced an underwritten public offering of its common stock. In addition, the Company is expected to grant the underwriters of the offering an option for a period of 30 days to purchase an additional 15% of the shares of common stock offered in the public offering under the same terms and conditions. The offering is subject to market and other conditions, and there can be no assurance as to whether or when the offering may be completed, or as to the actual size or terms of the offering.

Jefferies, TD Cowen, Leerink Partners and Stifel are acting as the joint book-running managers for the proposed offering. LifeSci Capital is acting as passive bookrunner for the proposed offering.

Spyre intends to use the net proceeds from the proposed public offering to continue to advance its programs in Gastroenterology, Rheumatology, and Dermatology, including to fund preclinical studies, clinical trials, manufacturing, and Phase 3 readiness, as well as a new program to advance SPY072 into late-stage development for hidradenitis suppurativa. Any remaining proceeds will be used for other ongoing research and development, working capital and other general corporate purposes.

A registration statement on Form S-3 (File No. 333-297063) relating to these securities has been filed with the Securities and Exchange Commission (the “SEC”) and became effective on June 26, 2026. This offering is being made solely by means of a prospectus supplement and accompanying prospectus. A preliminary prospectus supplement and accompanying prospectus relating to and describing the terms of the offering will be filed with the SEC and will be available on the SEC’s website located at http://www.sec.gov. When available, copies of the preliminary prospectus supplement and the accompanying prospectus related to the offering may be obtained from Jefferies LLC, Attention: Equity Syndicate Prospectus Department, 520 Madison Avenue, New York, NY 10022, by telephone at (877) 821-7388 or by email at Prospectus_Department@Jefferies.com; TD Securities (USA) LLC, Attention: Broadridge Financial Solutions, 1155 Long Island Avenue, Edgewood, NY 11717 or by email at TDManualrequest@broadridge.com; Leerink Partners LLC, Attention: Syndicate Department, 53 State Street, 40th Floor, Boston, MA 02109, by telephone at 1-800-808-7525 ext. 6105, or by email at syndicate@leerink.com; or Stifel, Nicolaus & Company, Incorporated, Attention: Syndicate, One Montgomery Street, Suite 3700, San Francisco, CA 94104, or by telephone at (415) 364-2720, or by email at syndprospectus@stifel.com. The final terms of the offering will be disclosed in a final prospectus supplement to be filed with the SEC.

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

About Spyre Therapeutics

Spyre Therapeutics is a clinical-stage biotechnology company committed to developing next-generation therapies that elevate the standard in immunology by delivering more complete disease control, greater durability, and a simpler treatment experience for patients. Spyre’s pipeline includes investigational extended half-life antibodies targeting a4p7, TL1A, IL-23, and IL-17A/F as well as rational combination programs.

Safe Harbor / Forward-Looking Statements

This press release contains “forward-looking” statements within the meaning of the safe harbor provisions of the U.S. Private Securities Litigation Reform Act of 1995. All statements contained in this press release, other than statements of historical fact are forward-looking statements. These forward-looking statements include statements regarding Spyre’s expectations regarding the proposed offering, including the timing, size, structure and completion of the proposed offering on the anticipated terms or at all and the satisfaction of customary closing conditions related to the offering. The words “believe,” “may,” “will,” “potentially,” “estimate,” “continue,” “anticipate,” “predict,” “target,” “intend,” “could,” “would,” “should,” “project,” “plan,” “expect,” the negatives of these terms, and similar expressions that convey uncertainty of future events or outcomes are intended to identify forward-looking statements, although not all forward-looking statements contain these identifying words.

These forward-looking statements are subject to a number of risks, uncertainties and assumptions, including, the Company’s anticipated timing of the offering, market conditions and satisfaction of customary closing conditions related to the offering, uncertainties and risks arising from regulatory feedback, including potential disagreement by regulatory authorities with the Company’s interpretation of data and the Company’s ongoing or planned clinical trials for its product candidates; the Company’s ability to elevate the standard in immunology by delivering more complete disease control, greater durability, and a simpler treatment experience for patients; the potential for interim data not being delivered within expected time frames or final data not being consistent with or different than the previously disclosed data reported for the Company’s programs; the expected or potential impact of macroeconomic conditions, including inflationary pressures, rising interest rates, general economic slowdown or a recession, changes in tariff/trade and monetary policy, volatile market conditions, financial institution instability, as well as geopolitical instability, including the ongoing military conflicts between the United States and Iran, Ukraine and Russia, conflicts in the Middle East, and geopolitical tensions between the United States and other countries, including China, on the Company’s operations; the implementation of changes in law, tariffs, sanctions, export or import controls, and other government measures that could impact the Company’s business operations, including restricting international trade by the United States, China or other countries; and those risks described in the Company’s most recent Annual Report on Form 10-K, its subsequent Quarterly Reports on Form 10-Q, as well as in other filings and reports that the Company makes from time to time with the SEC. Moreover, the Company operates in a very competitive and rapidly changing environment, and new risks emerge from time to time. It is not possible for the Company’s management to predict all risks, nor can the Company assess the impact of all factors on the Company’s business or the extent to which any factor, or combination of factors, may cause actual results to differ materially from those contained in any forward-looking statements it may make. In light of these risks, uncertainties, and assumptions, the forward-looking events and circumstances discussed in this press release may not occur and actual results could differ materially and adversely from those anticipated or implied in the forward-looking statements.

You should not rely upon forward-looking statements as predictions of future events. Although the Company believes that the expectations reflected in the forward-looking statements are reasonable, the Company cannot guarantee that the future results, levels of activity, performance or events and circumstances reflected in the forward-looking statements will be achieved or occur. The Company undertakes no obligation to update publicly any forward-looking statement for any reason after the date of this press release to conform these statements to actual results, to reflect changes in the Company’s expectations, or otherwise, except as required by law.

For Investors:
Eric McIntyre
VP of Finance and Investor Relations
Spyre Therapeutics
Eric.mcintyre@spyre.com 

For Media:
Josie Butler, 1AB
josie@1abmedia.com 

PHILADELPHIA, Oct. 05, 2026 (GLOBE NEWSWIRE) — Cabaletta Bio, Inc. (Nasdaq: CABA), a late-stage clinical biotechnology company focused on developing and launching curative targeted cell therapies designed specifically for patients with autoimmune diseases, today announced the grant of inducement equity awards to four newly hired non-executive employees as a material inducement to commencing their employment with the Company. The equity awards were approved in accordance with Nasdaq Listing Rule 5635(c)(4).

The inducement awards are as follows: (i) non-qualified stock options to purchase an aggregate of 200,000 shares of the Company’s common stock with an exercise price of $2.46 per share, which is equal to the closing price of the Company’s common stock as reported by Nasdaq on September 21, 2026, (ii) non-qualified stock options to purchase an aggregate of 100,000 shares of the Company’s common stock with an exercise price of $2.00 per share, which is equal to the closing price of the Company’s common stock as reported by Nasdaq on September 28, 2026, and (iii) non-qualified stock options to purchase an aggregate of 85,000 shares of the Company’s common stock with an exercise price of $2.00 per share, which is equal to the closing price of the Company’s common stock as reported by Nasdaq on October 2, 2026. Each option has a 10-year term and will vest over four years, with 25% of the underlying shares vesting on the one-year anniversary of the date of grant, and the remainder vesting in 12 equal quarterly installments for the three years thereafter. The stock options are subject to the terms and conditions of the Company’s 2025 Inducement Plan and the terms and conditions of the stock option agreements covering the grants.

About Cabaletta Bio
Cabaletta Bio (Nasdaq: CABA) is a late-stage clinical biotechnology company focused on developing and launching curative targeted cell therapies designed specifically for patients with autoimmune diseases. Cabaletta’s lead product candidate, rese-cel, is an investigational 4-1BB-containing fully human CD19-CAR T cell therapy being advanced across the RESET™ (REstoring SElf-Tolerance) clinical development program spanning multiple therapeutic areas, including rheumatology, neurology, and dermatology. Cabaletta Bio’s headquarters and labs are located in Philadelphia, PA. For more information, visit www.cabalettabio.com and connect with us on LinkedIn.

Contacts
Investors: investors@cabalettabio.com
Media: media@cabalettabio.com

– October 6 YouTube premiere featuring Sway Calloway, Howard “H” White and leading medical and cultural voices anchors community education nationwide

PALO ALTO, Calif., Oct. 05, 2026 (GLOBE NEWSWIRE) — BridgeBio Pharma, Inc. (Nasdaq: BBIO) (the “Company” or “BridgeBio”), a commercial-stage, multi-product biopharmaceutical company focused on genetic diseases, today announced a nationwide education effort with community partners to increase awareness of transthyretin amyloid cardiomyopathy, also called ATTR cardiac amyloidosis (ATTR-CM). ATTR-CM is an underrecognized cause of heart failure that occurs when TTR, a protein that plays an essential role in the transport of vitamin A and thyroxine, becomes unstable, breaks down and builds up in the heart, causing it to become thicker and stiffer and making it harder to pump blood effectively. Because symptoms may resemble more common heart conditions or be dismissed as normal aging, ATTR-CM can be overlooked or identified later in the disease journey.

The effort will begin with an October 6 YouTube premiere and continue through community conversations and educational programming leading up to World Amyloidosis Day on October 26.

The premiere features a candid conversation on Black men’s heart health and ATTR-CM moderated by veteran broadcaster, Sway Calloway. The panel includes sports executive, author, philanthropist and ATTR-CM advocate, Howard “H” White; Albert J. Hicks III, M.D., MPH, Director of Cardiopulmonary Care and Heart/Lung Transplant at Integris Baptist Medical Center in Oklahoma; and Hip Hop Public Health (HHPH) Founding Artist and Founder, Doug E. Fresh and HHPH Founder and Board Chair, Olajide Williams, M.D., M.S., who serve as Community and Health Education Partners for the initiative. The program will premiere October 6 at 6:00 pm EDT at HowardWhiteStory.com/premiere.

The nationwide effort is supported by community partners including the Association of Black Cardiologists (ABC), the National Minority Quality Forum (NMQF), 100 Black Men of the Bay Area, Inc. and the National Medical Association (NMA). Partners will host or support viewings and related educational programming at 40 locations nationwide, including Atlanta, Chicago, Houston, Los Angeles, New York, Oakland, and Washington D.C.

“ATTR-CM deserves greater attention as part of the cardiovascular health conversation, particularly for Black Americans who may be at increased risk. We’re proud to support BridgeBio in helping patients, families and healthcare professionals recognize when there may be more to a heart failure diagnosis,” said Kevin Kwaku, M.D., Ph.D., President of the Association of Black Cardiologists.

“Approximately 1 in 25 Black Americans carries a genetic variant associated with ATTR-CM, and too often the diagnosis comes only after the heart has already been significantly affected,” said Uma Sinha, Ph.D., Chief Scientific Officer at BridgeBio. “Our understanding of this progressive disease has moved faster than awareness of it. Shortness of breath, fatigue, and carpal tunnel in both wrists can be written off as aging or as a more common form of heart failure, and years can pass before anyone names the real cause. Putting clinicians, cultural leaders and Howard ‘H’ White’s lived experience in the same room, alongside partners rooted in these communities, is how we close this gap.”

At the center of the conversation is White, who is living with ATTR-CM and founded the Howard H. White Center for Cardiac Amyloidosis. Drawing on his own journey from symptoms to diagnosis, he has become a prominent voice for recognizing changes in one’s health, speaking up and advocating for answers.

As the Community and Health Education Partners, Dr. Williams and Doug E. Fresh reinforced the importance of moving health conversations from awareness to action, particularly through trusted voices, culture and community.

“At Hip Hop Public Health, we know that people are more likely to engage with health information when it is relevant to their lives and delivered through voices and cultural touchpoints they trust. Our goal is to make these conversations accessible and actionable, so people feel empowered to recognize changes in their health, ask questions and advocate for themselves and their families,” said Dr. Williams.

ATTR-CM exists in two forms: wild-type disease associated with aging and hereditary, or variant, disease passed through families. Certain variants are more commonly carried by people of African ancestry. Approximately 1 in 25 Black Americans in the United States carries the V142I, also known as V122I, variant associated with ATTR-CM, although not everyone who carries the variant will develop the disease.^1–3

“ATTR-CM can hide in plain sight because its symptoms often mirror heart failure we see every day. For Black patients, particularly those with ancestry-linked risk, knowing when to look beyond the familiar diagnosis can change the course of the disease,” said Dr. Hicks. 

The discussion also examines broader cardiovascular disparities affecting Black Americans and why greater awareness, earlier recognition and conversations with healthcare providers matter.

Watch the premiere on October 6 at 6:00 pm EDT at HowardWhiteStory.com/premiere.

Learn more about ATTR-CM and hear Howard “H” White’s story at HowardWhiteStory.com.

About Hip Hop Public Health
Hip Hop Public Health (HHPH) is a 501(c)(3) nonprofit organization that uses the power of music, culture and science to make health information accessible, relevant and actionable. Founded by Dr. Olajide Williams and Doug E. Fresh, HHPH develops evidence-based educational resources and community partnerships that advance health literacy, disease prevention and health equity. HHPH serves as the Community & Health Education Partner for this initiative. For more information, visit hhph.org.

About BridgeBio Pharma, Inc.
BridgeBio exists to develop transformative medicines for genetic conditions. Millions of people worldwide living with genetic conditions lack treatment options, often because drug development for small patient populations can be commercially challenging. We aim to bridge the gap between advancements in genetic science and meaningful medicines for underserved patient populations. Our decentralized, hub-and-spoke model is designed for speed, precision, and scalability. Autonomous and empowered teams focus on individual conditions, while a central hub provides the clinical, regulatory, and commercial capabilities needed to bring innovation to market. For more information, visit bridgebio.com and follow us on LinkedIn, X, Facebook, Instagram, YouTube and TikTok.

BridgeBio Pharma, Inc. Forward-Looking Statements
This press release contains forward-looking statements. Statements in this press release may include statements that are not historical facts and are considered forward-looking within the meaning of Section 27A of the Securities Act of 1933, as amended (the Securities Act), and Section 21E of the Securities Exchange Act of 1934, as amended (the Exchange Act), which are usually identified by the use of words such as “anticipates,” “believes,” “continues,” “estimates,” “expects,” “hopes,” “intends,” “may,” “plans,” “projects,” “remains,” “seeks,” “should,” “will,” and variations of such words or similar expressions. BridgeBio intends these forward-looking statements to be covered by the safe harbor provisions for forward-looking statements contained in Section 27A of the Securities Act and Section 21E of the Exchange Act. These forward-looking statements include statements regarding the planned YouTube premiere, community viewings and educational programming; BridgeBio’s plans to support ATTR-CM education and awareness; and the potential benefits of greater awareness, earlier recognition and diagnosis of ATTR-CM. Although the Company believes that its plans, intentions and expectations as reflected in or suggested by those forward-looking statements are reasonable, the Company can give no assurance that such plans, intentions or expectations will be attained or achieved. Actual results may differ materially from those described in the forward-looking statements due to a number of risks, uncertainties and assumptions, including those risks set forth in the Risk Factors section of the Company’s most recent Annual Report on Form 10-K and the Company’s other filings with the U.S. Securities and Exchange Commission. These forward-looking statements are based upon the current expectations and beliefs of the Company’s management as of the date of this press release. Except as required by applicable law, BridgeBio assumes no obligation to update publicly any forward-looking statements, whether as a result of new information, future events or otherwise.

BridgeBio Media Contact:
Kaitlyn Reilly, Director, Communications
contact@bridgebio.com
(650) 789-8220

BridgeBio Investor Contact:
Kristen Kelleher, Director, Investor Relations
ir@bridgebio.com

References
1. Attruby.com, “What Is ATTR-CM?” Disease overview and symptom information. Accessed January 27, 2026.
2. Attruby.com, “Signs & Symptoms” section. Accessed January 27, 2026.
3. Quarta CC, Buxbaum JN, Shah AM, et al. The amyloidogenic V122I transthyretin variant in elderly black Americans. N Engl J Med. 2015;372(1):21-29. Accessed January 27, 2026.

TORONTO, Oct. 05, 2026 (GLOBE NEWSWIRE) — (TSX: ASHR) Mulvihill Split Capital Share ETF has declared a monthly cash distribution in the amount of $0.25 per share, payable on November 6, 2026, to shareholders of record on October 30, 2026.
  
For further information, please contact Investor Relations at 416.681.3966, toll free at 1.800.725.7172, email at info@mulvihill.com or visit www.mulvihill.com.

John Germain, Senior Vice-President & CFO	Mulvihill Capital Management Inc. 25 King Street West Commerce Court North Suite 2110, Box 48 Toronto, Ontario, M5L 1A1

Commissions, trailing commissions, management fees and expenses all may be associated with investment funds. Please read the prospectus before investing. Investment funds are not guaranteed, their values change frequently and past performance may not be repeated.