STOCK TITAN

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

(Positive)
Tags
covid-19

Callan JMB (NASDAQ: CJMB) will oversee manufacturing, quality assurance, and distribution governance for Attune Biotech's investigational drug lodonal™ (JKB-122) under IND 181314 for the treatment of Long COVID.

Services include CMO qualification, batch record review, supply chain verification, surge capacity assessment, and distribution pathway validation. Attune plans a randomized Phase 2b/3 trial; lodonal™ remains investigational and is protected by IP through 2041.

Loading...
Loading translation...

Positive

  • FDA assigned IND 181314 for JKB-122 (lodonal™)
  • Attune plans a randomized, double-blind Phase 2b/3 trial for Long COVID
  • Callan JMB to provide independent manufacturing and quality oversight including CMO qualification and batch review
  • JKB-122 intellectual property protection extends through 2041

Negative

  • JKB-122 (lodonal™) is investigational and not FDA approved
  • No safety or efficacy clinical results are disclosed yet for JKB-122

News Market Reaction – CJMB

+5.11%
2 alerts
+5.11% Session close to close
+3.2% Peak Tracked
-9.2% Trough Tracked
$8.55M Market Cap
0.0x Rel. Volume

In the Mar 11 session, CJMB gained 5.11%, reflecting a notable positive market reaction. Argus tracked a peak move of +3.2% during that session. Argus tracked a trough of -9.2% from its starting point during tracking. Our momentum scanner triggered 2 alerts that day, indicating moderate trading interest and price volatility.

Data tracked by StockTitan Argus on the day of publication.

Market Context

The stock moved +5.1% in the session following this news. A strong positive reaction aligns with how...
Analysis

The stock moved +5.1% in the session following this news. A strong positive reaction aligns with how CJMB previously traded on COVID-related milestones, such as the +9.86% move after its Oregon emergency contract. The new Long COVID IND support deepens exposure to clinical logistics alongside earlier Attune agreements and prior government work. However, a small market cap of about $8.09M and thin float can amplify swings, so sharp gains have historically been vulnerable to volatility once initial enthusiasm faded.

Key Figures

IND number: IND 181314 Long COVID patients: 20 million Americans Parallel programs: 5 clinical programs +2 more
5 metrics
IND number IND 181314 FDA-assigned IND for JKB-122 (lodonal™) in Long COVID
Long COVID patients 20 million Americans Estimated living with Long COVID or persistent post-COVID symptoms
Parallel programs 5 clinical programs Lodonal™ in Long COVID and four additional indications
Trial phase Phase 2b/3 Planned randomized, double-blind, placebo-controlled, multi-center trial
IP term Through 2041 Intellectual property protection term for JKB-122

Previous Covid-19 Reports

1 past event · Latest: Feb 11 (Positive)
Same Type Pattern 1 events
Date Event Sentiment 24h Move Catalyst
Feb 11 COVID contract win Positive +9.9% Second five-year Oregon contract after successful COVID and MPOX logistics.

24h Move is the share-price change in the day after each event; other market factors may also have contributed.

Pattern Detected

COVID-related contracts previously coincided with a positive single-day price reaction.

Recent Company History

Recent news for Callan JMB has focused on expanding healthcare logistics capabilities and partnerships. A key COVID‑19–tagged event on Feb 11, 2025 detailed a second 5‑year emergency preparedness contract with the Oregon Health Authority after successful COVID‑19 and MPOX operations, handling over 800,000 vaccines across 75,000 miles. That announcement saw a +9.86% reaction, showing prior market sensitivity to pandemic-related logistics wins. Today’s Long COVID trial support role fits this broader theme of specialized health logistics.

Key Terms

investigational new drug, phase 2b/3, double-blind, placebo-controlled, +3 more
7 terms
investigational new drug regulatory
"to support its investigational new drug clinical trials for the treatment"
An investigational new drug is a medication that is still being tested in clinical trials to determine if it is safe and effective for treating a specific condition. For investors, it represents a potential breakthrough that could lead to a new treatment and significant financial gains if successful, but also carries risks since it has not yet been approved for widespread use.
phase 2b/3 medical
"initiate a randomized, double-blind, placebo-controlled, multi-center Phase 2b/3 clinical trial"
A phase 2b/3 trial is a combined late-stage clinical study that first refines the best dose and measures how well a treatment works (phase 2b) then expands to a larger, definitive test of safety and effectiveness needed for regulatory approval (phase 3). For investors, results from a phase 2b/3 act like a dress rehearsal that turns into opening night: positive, well-controlled outcomes substantially raise the chance of approval and future sales, while failures can sharply reduce a drug’s value.
double-blind medical
"initiate a randomized, double-blind, placebo-controlled, multi-center Phase 2b/3"
A double-blind process means that neither the people conducting an activity nor the people involved know certain key details, such as who is receiving a treatment or a placebo. This approach helps prevent bias from influencing the results, making the outcome more trustworthy. For investors, it ensures that decisions or judgments are based on unbiased information rather than preconceived opinions or expectations.
placebo-controlled medical
"randomized, double-blind, placebo-controlled, multi-center Phase 2b/3 clinical trial"
"Placebo-controlled" describes a testing method where one group receives the actual treatment or intervention, while another group receives a harmless, inactive version called a placebo. This approach helps determine whether the real treatment has genuine effects beyond psychological expectations. For investors, understanding this ensures confidence that reported benefits are real and not influenced by bias or false perceptions.
multi-center medical
"placebo-controlled, multi-center Phase 2b/3 clinical trial evaluating the safety"
Multi-center describes a study, clinical trial, or project carried out at several separate hospitals, clinics, or research sites rather than at a single location. For investors, multi-center work generally means results are gathered from a broader set of patients and conditions, making findings more reliable and faster to enroll, but also more costly and complex to coordinate—like testing a product in many stores to see how it performs across different neighborhoods.
tlr4 antagonist medical
"lodonal™ (JKB-122) is a first-in-class TLR4 antagonist for immune restoration"
A TLR4 antagonist is a drug or molecule that blocks the Toll-like receptor 4 (TLR4), a sensor on immune cells that detects danger signals and can trigger strong inflammation. By quieting that overactive alarm, these compounds aim to reduce harmful inflammation in conditions such as severe infections, autoimmune disorders, or chronic inflammatory diseases, making them promising but high‑risk development candidates for investors tracking therapeutic pipelines and regulatory milestones.
intellectual property regulatory
"JKB-122 is protected by issued intellectual property extending through 2041."
Intellectual property are legal rights that protect creations of the mind—such as inventions, brand names, designs, software, or secret formulas—giving the owner control over who can use, copy or sell them. For investors, IP is like owning a blueprint or recipe: it can generate steady income through exclusive sales or licensing, boost a company’s competitive edge and valuation, and also create costs or risks if rights must be defended or challenged in court.

AI-generated analysis. How Rhea-AI works. Not financial advice.

See more from StockTitan in Google Search and AI answers. Adds StockTitan as a preferred source · opens Google
Add on Google

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

What does IND 181314 mean for Callan JMB (CJMB) and Attune's lodonal™ program?

IND 181314 means the FDA has accepted an investigational filing to allow clinical study of lodonal™. According to Attune, this enables initiation of human trials and regulatory oversight while the product remains investigational and unapproved.

What manufacturing oversight will Callan JMB (CJMB) provide for lodonal™ under the IND?

Callan JMB will provide independent CMO qualification, batch record review, supply chain verification, and distribution validation. According to Callan JMB, these services aim to ensure manufacturing integrity and regulatory compliance during clinical development.

When will Attune start the Phase 2b/3 trial for JKB-122 (lodonal™) indicated under IND 181314?

Attune intends to initiate a randomized, double-blind, placebo-controlled Phase 2b/3 trial under IND 181314. According to Attune, the trial will evaluate safety, tolerability, and efficacy in adults diagnosed with Long COVID.

Does lodonal™ (JKB-122) have FDA approval for Long COVID treatment now?

No, lodonal™ remains investigational and has not been approved by the FDA. According to Attune, the drug is under clinical study and approval will depend on future trial safety and efficacy results.

How might Callan JMB's (CJMB) oversight affect lodonal™ trial readiness and supply chain reliability?

Independent oversight can strengthen manufacturing readiness, CMO validation, and supply chain integrity before trials. According to Callan JMB, their governance intends to accelerate trial launch while ensuring compliance with federal standards.