MARKET WIRE NEWS

Callan JMB Inc. to Oversee Manufacturing and Quality Control of Attune Biotech's IND Clinical Trials for lodonal(TM) in the Treatment of Long COVID

MWN-AI** Summary

Callan JMB Inc. (NASDAQ: CJMB) has entered into an agreement with Attune Biotech Inc. to oversee the manufacturing and quality control processes for Attune's investigational new drug, JKB-122 (lodonal™), targeting Long COVID, or Post-Acute Sequelae of SARS-CoV-2 infection (PASC). With approximately 20 million Americans affected by Long COVID and no FDA-approved treatments available, this collaboration is pivotal in addressing a significant healthcare gap.

Under IND application number 181314, Callan JMB will serve as an independent third-party overseer, ensuring compliance with federal regulations as Attune moves forward with its clinical trials. The oversight will include critical functions such as Contract Manufacturing Organization (CMO) qualification, batch record reviews, supply chain verification, and distribution pathway validation.

Located in Spring Branch, Texas, Callan JMB specializes in integrative logistics solutions, offering services that enhance the operational efficacy of healthcare entities and emergency management agencies. The company's extensive experience in managing federal health programs positions it uniquely to support Attune Biotech in navigating the complexities of drug manufacturing and compliance.

Attune Biotech, a clinical-stage biotechnology firm, is developing lodonal™ as a TLR4 antagonist aimed at restoring immune function. Its clinical pipeline is diverse, focusing not only on Long COVID but also on conditions such as HIV immune non-responders and autoimmune diseases. The company is committed to using established regulatory frameworks to advance its therapies.

The partnership promises to facilitate the initiation of a randomized, double-blind, placebo-controlled clinical trial for lodonal™, with Callan JMB’s expertise expected to ensure the integrity and compliance of the manufacturing process. Both companies emphasize the importance of this collaboration in addressing the urgent unmet medical needs related to Long COVID, aligning their resources and strategies to improve patient outcomes.

MWN-AI** Analysis

Callan JMB Inc. (NASDAQ: CJMB) recently announced a pivotal agreement to oversee Attune Biotech’s clinical trials for their investigational drug, lodonal™ (JKB-122), aimed at treating Long COVID—an emerging ailment affecting millions of Americans. This partnership positions Callan JMB as a crucial player in the burgeoning biopharmaceutical sector, particularly as it pertains to underserved medical conditions.

Investors should view this collaboration positively, given the critical demand for effective treatments for Long COVID, a condition currently lacking FDA-approved therapies. The significant population affected—approximately 20 million Americans—highlights both the social impact and market potential of lodonal™. As Callan JMB assumes a role in quality control and manufacturing oversight, their expertise in supply chain logistics and regulatory compliance could serve as a competitive advantage that enhances the integrity and efficacy of the trial process.

In addition, the FDA's acceptance of Attune's IND application underscores the credibility and potential of these clinical trials. The ongoing focus on immune restoration therapies, particularly those targeting chronic inflammatory conditions, further enhances the investment thesis for Callan JMB. With intellectual property protection extending through 2041, the long-term prospects for financial returns could be substantial if lodonal™ successfully navigates clinical trials.

However, potential investors should remain cautious. As with any biopharmaceutical endeavor, there are inherent risks associated with clinical trials and regulatory approvals. The development timelines can be lengthy, and outcomes uncertain.

In conclusion, while Callan JMB Inc. presents an intriguing investment opportunity backed by a strategic partnership in the biopharmaceutical landscape, it is crucial for investors to monitor updates regarding the trial progress and regulatory environment. Balancing the potential for growth with inherent risks will be essential in determining the viability of this investment.

**MWN-AI Summary and Analysis is based on asking OpenAI to summarize and analyze this news release.

Source: GlobeNewswire

Callan JMB will Provide Independent Manufacturing Oversight and Governance as lodonal Undergoes Clinical Trials for Underserved Patient Population

SPRING BRANCH, Texas, March 11, 2026 (GLOBE NEWSWIRE) -- Callan JMB Inc. (NASDAQ: CJMB), (“Callan JMB” or the “Company”), an integrative logistics company empowering the healthcare industry and emergency management agencies through fulfillment, storage, monitoring, and cold chain logistics services, today announced that it has agreed with Biostax Corp d/b/a Attune Biotech Inc. (“Attune”), a clinical-stage biopharmaceutical company with a diversified therapeutic pipeline, to support its investigational new drug clinical trials for the treatment of Post-Acute Sequelae of SARS-CoV-2 infection (“PASC”), commonly known as Long COVID.

The Company previously announced in January 2026, that it had signed a strategic teaming agreement with Attune, whereby Callan JMB serves as independent third-party overseer of Attune's manufacturing, quality assurance and control, and deployment operations. Under this agreement, Callan JMB will provide the following services and oversight for IND 181314 for JKB-122 (lodonal), including Contract Manufacturing Organization (CMO) qualification and validation, comprehensive batch record review, supply chain verification and integrity confirmation, surge manufacturing capacity assessment, and distribution pathway validation.

Attune has received notification that the U.S. Food and Drug Administration (FDA) has received and assigned Investigational New Drug (IND) application number 181314 for JKB-122 (lodonal) for treatment of Long COVID, which remains a condition for which no FDA-approved therapies are currently indicated. Patients of Long COVID are currently underserved, with approximately 20 million Americans estimated to be living with Long COVID or persistent post-COVID symptoms1. In addition, the U.S. Department of Health and Human Services (HHS) has issued formal guidance titled “Long COVID as a Disability Under the ADA, Section 504, and Section 1557” (last reviewed July 2025), confirming that Long COVID may qualify as a disability under federal civil rights statutes where symptoms substantially limit major life activities.

“When we signed the agreement with Attune at the beginning of the year, we were excited by the potential that several of their products demonstrate to address conditions that remain significantly underserved, such as Long COVID,” said Wayne Williams, Founder and Chief Executive Officer of Callan JMB. “This is the latest step in the development of their product pipeline, and we are proud to serve as the overseer of their manufacturing and governance. The development of these types of products is critical to addressing these underserved conditions, and with our experience managing federal health programs, we can help accelerate this work efficiently while ensuring compliance with federal regulations.”

“Our partnership with Callan JMB is essential to the work we are doing, ensuring that we meet the stringent guidelines set out by the federal government, as we undergo this next phase in the development of lodonal for the treatment of Long COVID,” said Noreen Griffin, Chief Executive Officer of Attune. “With their long-standing federal relationships and experience as well as proven operational framework, Callan JMB is uniquely suited to support the continued advancement of our development pipeline and the launch of upcoming clinical trials.”

lodonal (JKB-122) is a first-in-class TLR4 antagonist for immune restoration, currently in development across five parallel clinical programs including Long COVID, HIV immune non-responders, autoimmune hepatitis, metabolic liver diseases (MASLD/MASH), and chronic immune pain. Under IND 181314, Attune intends to initiate a randomized, double-blind, placebo-controlled, multi-center Phase 2b/3 clinical trial evaluating the safety, tolerability, and efficacy of JKB-122 (lodonal) in adults diagnosed with PASC or Long COVID. The product remains investigational and has not been approved by the U.S. Food and Drug Administration. JKB-122 is protected by issued intellectual property extending through 2041.

About Callan JMB Inc.

Callan JMB Inc. is a vertically integrated logistics company empowering the healthcare industry and emergency management agencies through fulfillment, storage, monitoring, and cold chain logistics services to secure medical materials and protect patients and communities with compliant, safe, and effective medicines. Our combined expertise in supply chain logistics, thermodynamics, biologics, inventory management, regulatory compliance and emergency preparedness is unparalleled in the industry. We offer a gold standard in client experience with customizable interfaces, next-level reliability in shipping and environmental sustainability in our specialty packaging.

About Biostax Corp d/b/a Attune Biotech Inc.

Biostax Corp, operating as Attune Biotech, is a clinical-stage biotechnology company developing JKB-122 (lodonal) as a host-directed immunomodulatory therapy designed to recalibrate dysregulated innate immune signaling. The company focuses on diseases characterized by chronic inflammation, immune dysfunction, and persistent inflammatory signaling. Attune advances its programs through established regulatory pathways, validated CMC standards, biomarker-informed development strategies, and intellectual property protection extending through 2041.

Forward-Looking Statement

This press release contains “forward-looking statements” within the meaning of Section 27A of the Securities Act of 1933, as amended, and Section 21E of the Securities Exchange Act of 1934, as amended (the “Exchange Act”) (which Sections were adopted as part of the Private Securities Litigation Reform Act of 1995). Statements preceded by, followed by or that otherwise include the words “believe,” “anticipate,” “estimate,” “expect,” “intend,” “plan,” “project,” “prospects,” “outlook,” and similar words or expressions, or future or conditional verbs, such as “will,” “should,” “would,” “may,” and “could,” are generally forward-looking in nature and not historical facts. These forward-looking statements involve known and unknown risks, uncertainties and other factors which may cause the Company’s actual results, performance, or achievements to be materially different from any anticipated results, performance, or achievements for many reasons. The Company disclaims any intention to, and undertakes no obligation to, revise any forward-looking statements, whether as a result of new information, a future event, or otherwise. For additional risks and uncertainties that could impact the Company’s forward-looking statements, please see the Company’s Registration Statement Under the Securities Act of 1933 on Form S-1, including but not limited to the discussion under “Risk Factors” therein, which the Company filed with the SEC and which may be viewed at http://www.sec.gov/.

Investor Contacts:
Valter Pinto, Managing Director
KCSA Strategic Communications
CallanJMB@kcsa.com
212.896.1254


1 Yale Medicine. Long COVID: Economic and Public Health Impact Overview, 2023.


FAQ**

How does Callan JMB Inc. (NASDAQ: CJMB) plan to ensure compliance with federal regulations while providing independent oversight for Attune's manufacturing and clinical trial processes for lodonal™?

Callan JMB Inc. plans to ensure compliance with federal regulations for Attune's manufacturing and clinical trial processes for lodonal™ by implementing rigorous oversight mechanisms and leveraging industry best practices while maintaining transparency and accountability throughout the processes.

What specific metrics will Callan JMB Inc. (CJMB) utilize to assess the effectiveness of its oversight during the clinical trials for lodonal™ aimed at treating Long COVID?

Callan JMB Inc. (CJMB) will utilize metrics such as patient enrollment rates, adherence to trial protocols, incidence of adverse events, data quality and integrity, efficacy endpoints based on clinical outcomes, and patient-reported outcomes to assess oversight effectiveness.

Can you elaborate on how Callan JMB Inc. (CJMB) intends to address the logistical challenges involved in the surge manufacturing capacity assessment for Attune's lodonal™?

Callan JMB Inc. plans to tackle the logistical challenges of the surge manufacturing capacity assessment for Attune's lodonal™ by implementing streamlined supply chain processes, optimizing production workflows, and leveraging advanced technologies for efficient resource allocation.

What role will Callan JMB Inc. (NASDAQ: CJMB) play in verifying the supply chain integrity for the clinical trials of lodonal™, and what steps will be taken to ensure patient safety during this process?

Callan JMB Inc. (NASDAQ: CJMB) will oversee the verification of supply chain integrity for lodonal™ clinical trials by implementing rigorous monitoring protocols and compliance checks, ensuring all materials are sourced ethically and safely to prioritize patient safety.

**MWN-AI FAQ is based on asking OpenAI questions about Callan JMB Inc. (NASDAQ: CJMB).

Callan JMB Inc.

NASDAQ: CJMB

CJMB Trading

-3.23% G/L:

$1.80 Last:

134,353 Volume:

$1.86 Open:

mwn-ir Ad 300

CJMB Latest News

CJMB Stock Data

$7,997,837
1,207,997
1.9%
3
N/A
Transportation
Industrials
US
Spring Branch

Subscribe to Our Newsletter

Link Market Wire News to Your X Account

Download The Market Wire News App