Connect Biopharma Highlights New Mechanism of Action Data for Rademikibart and Outlines Priorities for 2026

Rhea-AI Summary

Connect Biopharma (Nasdaq: CNTB) highlighted new mechanism‑of‑action data for rademikibart and outlined 2026 priorities, emphasizing clinical execution. Mechanistic studies show enhanced IL‑4R binding, greater internalization versus dupilumab, and stronger rescue of β‑agonist responsiveness in human airway models, supporting faster, larger FEV1 improvements observed previously. Ongoing Phase 1b IV study has shown preliminary faster FEV1 increases versus subcutaneous dosing with topline results expected in Q1 2026. Phase 2 Seabreeze STAT asthma and COPD trials are recruiting with topline data expected mid‑2026. Cash, cash equivalents and short‑term investments were $54.8M as of Sept 30, 2025, with runway into 2027 under current plans.

Positive

• MOA data shows enhanced IL‑4R binding and greater internalization versus dupilumab
• Preclinical models show rademikibart rescues β‑agonist responsiveness in human lung tissue
• Phase 1b IV study reported faster FEV1 increases versus subcutaneous dosing (preliminary)
• Topline results expected: Phase 1b Q1 2026 and Seabreeze STAT mid‑2026
• Cash, cash equivalents and short‑term investments of $54.8M as of Sept 30, 2025; runway into 2027

Negative

• None.

News Market Reaction – CNTB

-1.40%

4 alerts

-1.40% News Effect

-$2M Valuation Impact

$126M Market Cap

0.4x Rel. Volume

On the day this news was published, CNTB declined 1.40%, reflecting a mild negative market reaction. Our momentum scanner triggered 4 alerts that day, indicating moderate trading interest and price volatility. This price movement removed approximately $2M from the company's valuation, bringing the market cap to $126M at that time.

Data tracked by StockTitan Argus on the day of publication.

Key Figures

Cash & investments: $54.8 million Cash runway: into 2027

2 metrics

Cash & investments $54.8 million Cash, cash equivalents and short-term investments as of September 30, 2025

Cash runway into 2027 Management expects runway into 2027 under current operating plans

Market Reality Check

Price: $2.65 Vol: Volume 37,790 is below 20...

low vol

$2.65 Last Close

Volume Volume 37,790 is below 20-day average 111,953 (relative volume 0.34x). low

Technical Shares trade above the 200-day moving average of 1.58, despite a -3.59% daily move.

Peers on Argus

CNTB was down 3.59% while peers showed mixed moves: COYA, OVID and IFRX were neg...

1 Up

CNTB was down 3.59% while peers showed mixed moves: COYA, OVID and IFRX were negative, STTK modestly positive, and VXRT sharply higher at 40.21%. Momentum scanner only flagged ATRA on the upside, supporting a stock-specific reaction rather than a coordinated sector move.

Historical Context

5 past events · Latest: Nov 24 (Neutral)

Pattern 5 events

Date	Event	Sentiment	Move	Catalyst
Nov 24	Conference participation	Neutral	-4.3%	Announced management fireside chat at Evercore healthcare conference webcast.
Nov 12	Earnings and update	Positive	+5.9%	Reported Q3 2025 results, positive asthma data and cash runway into 2027.
Sep 29	Clinical data update	Positive	-16.6%	Presented Phase 2b rademikibart data with strong FEV1 gains and fewer exacerbations.
Sep 4	Conference preview	Positive	-10.6%	Announced two ERS 2025 posters on rademikibart effectiveness and FEV1 impact.
Sep 3	Listing structure change	Neutral	-5.7%	Completed ADR termination and direct Nasdaq listing of ordinary shares.

Pattern Detected

Recent CNTB news, often positive or neutral on rademikibart and corporate developments, has frequently coincided with negative price reactions, with only one clear positive alignment on earnings.

Recent Company History

Over the last six months, CNTB highlighted multiple milestones centered on rademikibart and capital-markets positioning. In Sep 2025, it completed ADR termination and a direct Nasdaq listing, while executing Phase 2 Seabreeze STAT studies. Subsequent ERS 2025 presentations in late September showcased substantial FEV1 gains and exacerbation reductions, yet shares sold off after several of these updates. The Nov 12, 2025 Q3 results, reaffirming cash of $54.8M and runway into 2027, drew the only clearly positive 24-hour reaction. Today’s mechanism-of-action and 2026-priorities update fits this ongoing clinical execution narrative.

Market Pulse Summary

This announcement highlights expanded mechanism-of-action data for rademikibart, suggesting a differ...

Analysis

This announcement highlights expanded mechanism-of-action data for rademikibart, suggesting a differentiated profile versus existing IL-4/IL-13 blockade and outlining key 2026 milestones, including Phase 1b IV data in the first quarter and Phase 2 Seabreeze STAT readouts by mid-2026. With cash, cash equivalents and short-term investments of $54.8 million and runway into 2027, the company has resources to reach these catalysts. Investors may watch clinical timelines and how future efficacy and safety data support the best-in-class thesis.

Key Terms

mechanism of action, phase 1b, phase 2, fev1, +4 more

8 terms

mechanism of action medical

"Announced new data demonstrating a unique mechanism of action supporting..."

Mechanism of action describes how a drug, therapy, or medical product produces its effect in the body—the specific steps, targets, and biological processes it engages, like a key fitting into a lock to open a door. Investors care because a clear, well-understood mechanism reduces scientific uncertainty, supports regulatory approval and market confidence, and helps predict safety, effectiveness and additional uses, all of which influence a product’s commercial potential and a company’s valuation.

phase 1b medical

"Recruitment ongoing for Phase 1b study of intravenously-administered rademikibart..."

"Phase 1b" is an early stage in testing a new medical treatment or vaccine, where it is given to a small group of people to evaluate its safety and determine the right dose. For investors, this phase signals progress in development, indicating the treatment is advancing through initial safety checks, which can influence expectations for future success and potential market impact.

phase 2 medical

"Recruitment ongoing for Phase 2 Seabreeze STAT studies for acute exacerbations..."

Phase 2 is the mid-stage clinical trial where a new drug or treatment is tested in a larger group of patients to see if it works and to keep checking safety after initial human testing. Think of it as a field test that proves whether a product actually delivers its promised benefit. Investors watch Phase 2 closely because its results strongly influence a medicine’s chances of reaching the market, the size of its potential sales, and the company’s valuation.

fev1 medical

"resulting in rapid onset of action, greater improvement in FEV1 and reduced..."

FEV1 stands for forced expiratory volume in one second, a medical measurement of how much air a person can forcibly exhale in one second during a breathing test. Think of it like timing how quickly someone can blow out a candle — it gives a clear snapshot of lung strength and airflow. Investors watch FEV1 because changes in this measure are used to judge whether respiratory drugs or devices work, which affects regulatory approval, market potential, and sales forecasts.

eosinophil medical

"greater improvement in FEV1 and reduced eosinophil-related side effects."

A type of white blood cell that acts like a specialized security guard in the body, targeting certain infections, allergies and inflammatory responses. For investors, eosinophil levels matter because they are used as a measurable indicator in drug trials, diagnostic tests and safety monitoring; changes can affect a therapy’s market prospects, regulatory review and commercial use much like a key performance metric influences a company's valuation.

il-4 medical

"reverse the negative effects on airway function of IL-4 and IL-13 resulting..."

Interleukin-4 (IL-4) is a small signaling protein the immune system uses like a messenger to tell certain white blood cells how to respond, especially in allergic and inflammatory reactions. It matters to investors because drugs that block or mimic IL-4 can treat conditions such as asthma and eczema, so IL-4 levels and related trial results act as important biomarkers that influence clinical outcomes, regulatory decisions, and commercial potential in biotech and pharmaceutical markets.

il-13 medical

"reverse the negative effects on airway function of IL-4 and IL-13 resulting..."

IL-13 is a small signaling protein produced by the immune system that plays a key role in allergic inflammation and certain lung and fibrotic diseases; think of it as a radio message that tells cells to make mucus, narrow airways, or lay down scar tissue. For investors, IL-13 matters because therapies that block or measure it can change patient outcomes and determine the success of clinical trials, regulatory approvals, and the value of companies developing targeted drugs.

il-4r medical

"Rademikibart’s enhanced binding affinity to the IL-4R creates a more stable complex..."

IL-4R is a protein on the surface of certain immune cells that acts like a lock for the signaling molecule interleukin-4; when the signal fits the lock it tells the cell to ramp up allergic and inflammatory responses. Investors watch IL-4R because drugs that block or modulate this receptor can reduce asthma, eczema, and other immune-driven diseases, making successful therapeutics potentially valuable assets in biotech portfolios.

AI-generated analysis. Not financial advice.

– Announced new data demonstrating a unique mechanism of action supporting the best-in-class potential of rademikibart –

– Recruitment ongoing for Phase 1b study of intravenously-administered rademikibart designed to further confirm its unique ability to rapidly improve airway function with topline results expected in first quarter 2026 –

– Recruitment ongoing for Phase 2 Seabreeze STAT studies for acute exacerbations in asthma and COPD; expect to report topline data from both studies in mid-2026 –

– Strong balance sheet with cash runway into 2027 through key clinical catalysts –

SAN DIEGO, Jan. 12, 2026 (GLOBE NEWSWIRE) -- Connect Biopharma Holdings Limited (Nasdaq: CNTB) (Connect Biopharma, Connect or the Company), a clinical-stage biopharmaceutical company focused on transforming care for the treatment of inflammatory diseases, today highlighted new mechanism of action data for rademikibart and outlined its priorities for 2026.

“Following a transformative year, we are entering 2026 with a focus on clinical execution,” said Barry Quart, Pharm.D., CEO and Director of Connect Biopharma. “The new mechanism of action (MOA) data further demonstrate rademikibart’s unique pharmacologic profile supporting its potential to rapidly reverse the negative effects on airway function of IL-4 and IL-13 resulting in rapid onset of action, greater improvement in FEV₁ and reduced eosinophil-related side effects. Consistent with these MOA results, preliminary data from our ongoing Phase 1b intravenous administration (IV) study demonstrate increases in FEV₁ significantly faster than observed with subcutaneous administration. We anticipate reporting topline data from this Phase 1b study in first quarter and our Seabreeze STAT studies in acute asthma and COPD midyear.”

Recent Updates

Development Highlights

• New mechanism of action data supports the use of rademikibart in combination with standard of care β-agonists to reverse acute exacerbations and for maintenance therapy in asthma and COPD.
  
  
  • Rademikibart’s enhanced binding affinity to the IL-4R creates a more stable complex compared to dupilumab. Additionally, binding epitopes of rademikibart, but not dupilumab, on IL-4Rα overlap more closely with the conserved binding interface naturally utilized by IL-4 and IL-13 cytokines resulting in greater internalization, providing mechanistic support for rademikibart’s differentiated efficacy and safety profile.
    
  • In vitro human airway smooth muscle (HASM) cell and human precision cut lung slice (hPCLS) experiments with rademikibart demonstrated clear differentiation to dupilumab with substantially greater improvement in responsiveness to β-agonist treatment with rademikibart in the presence of IL-4/IL-13.
  • Treatment with rademikibart substantially reversed IL-13 induced hyporesponsiveness to β-agonist treatment, whereas treatment with dupilumab had no rescue effect in hPCLS.
  • The mechanism of action studies completed to-date provide the potential basis for the large and rapid FEV₁ improvement observed in our previously completed Phase 2b chronic asthma study.

• Initiated Phase 1b clinical pharmacology study with IV rademikibart to evaluate opportunity to reverse bronchoconstriction even more quickly than subcutaneous dosing; expect to report topline results in the first quarter of 2026.
  
• Recruitment of participants into the Phase 2 Seabreeze STAT asthma and Seabreeze STAT COPD studies evaluating the safety and efficacy of rademikibart as an adjunct treatment for acute exacerbations is ongoing with topline data from both studies expected in mid-2026.
  

Financial Guidance

• Cash, cash equivalents and short-term investments were $54.8 million as of September 30, 2025. Based on its current operating plans, the Company expects that its cash, cash equivalents and short-term investments will be sufficient to fund operations into 2027.
  

About Rademikibart

Rademikibart is a fully human monoclonal antibody targeting interleukin-4 receptor alpha (IL-4Rα), a common subunit of interleukin-4 receptor (IL-4) and interleukin-13 receptor (IL-13). We believe that by binding with IL-4Rα, rademikibart can block the functions of IL-4 and IL-13 effectively, thereby blocking the T helper 2 (Th2) inflammatory pathway to achieving the goal of treating Th2-related inflammatory diseases such as atopic dermatitis, asthma and COPD.

About Connect Biopharma

Connect Biopharma is a clinical-stage biopharmaceutical company dedicated to transforming care for asthma and COPD. Headquartered in San Diego, California, the Company is advancing rademikibart, a next-generation, potentially best-in-class antibody designed to target IL-4Rα. The Company is currently conducting global clinical studies of rademikibart for the treatment of acute exacerbations of asthma and COPD, areas with significant unmet need. Connect has granted an exclusive license to Simcere Pharmaceutical Co., Ltd., for rademikibart in Greater China. Under the exclusive license and collaboration agreement, Connect is eligible to receive remaining milestone payments up to an aggregate amount of approximately $110 million upon the achievement of certain development, regulatory and commercial milestones. Connect is also eligible to receive royalties at tiered percentage rates up to low double-digit percentages on net sales in Greater China.

For more information visit www.connectbiopharma.com.

Forward-Looking Statements

This press release contains “forward-looking statements” within the meaning of the Private Securities Litigation Reform Act of 1995, as amended (the “Act”). Forward-looking statements are statements that are not of historical fact and include, without limitation, statements regarding future events, our future financial condition, results of operations, business strategy and plans, prospective products (as well as their potential to achieve a differentiated, competitive, or favorable benefit or profile or trend, including on safety, tolerability, improvement, maintenance, clinical response, dosing, efficacy and/or convenience), planned or expected product approval applications or approvals, anticipated milestones, expected data readouts and enrollments, research and development plans and costs, potential future partnerships, expectations about existing partnerships, timing and likelihood of success, objectives of management for future operations, future results of anticipated product development efforts, and adequacy of existing cash and potential partnership funding to fund operations and capital expenditure requirements, as well as statements regarding industry trends. These statements are based on management’s current expectations of future events only as of the date of this press release and are inherently subject to a number of risks, uncertainties and assumptions, some of which cannot be predicted or quantified and some of which are beyond our control, including, among other things: the ability of our clinical trials to demonstrate safety and efficacy of our product candidates and other positive results; whether we will need expanded or additional trials in order to obtain regulatory approval for our product candidates; our ability to obtain and maintain regulatory approval of our product candidates; existing regulations and regulatory developments in the U.S., the PRC, Europe and other jurisdictions; the ability of our current cash and investments position to support planned operations; our plans and ability to obtain, maintain, protect and enforce our intellectual property rights and our proprietary technologies, including extensions of existing patent terms where available; our continued reliance on third parties to conduct additional clinical trials of our product candidates, and for the manufacture of our product candidates for preclinical studies and clinical trials; and the degree of market acceptance of our product candidates, if approved, by physicians, patients, healthcare payors and others in the medical community.

Words such as “aim,” “anticipate,” “believe,” “could,” “expect,” “feel,” “goal,” “intend,” “look forward to,” “may,” “optimistic,” “plan,” “potential,” “promising,” “will,” and similar expressions are intended to identify forward-looking statements, though not all forward-looking statements necessarily contain these identifying words. The inclusion of forward-looking statements should not be regarded as a representation by Connect Biopharma that any of its expectations, projections or plans will be achieved. Actual results may differ materially due to the risks and uncertainties inherent in our business and other risks described in our filings with the U.S. Securities and Exchange Commission (the “SEC”). Further information regarding these and other risks is included under the heading “Risk Factors” in our annual and periodic reports filed with the SEC. These forward-looking statements should not be taken as forecasts or promises nor should they be taken as implying any indication, assurance or guarantee that the assumptions on which such forward-looking statements have been made are correct or exhaustive or, in the case of the assumptions, fully stated in this presentation. Drug development and commercialization involve a high degree of risk, and only a small number of research and development programs result in commercialization of a product. Results in early-stage clinical trials may not be indicative of full results or results from later stage or larger scale clinical trials and do not ensure regulatory approval. You are cautioned not to place undue reliance on the scientific data presented or any forward-looking statements, which speak only as of the date of such presentation(s) or such statements. Except as required by law, Connect Biopharma undertakes no obligation to publicly update any forward-looking statements, whether because of new information, future events or otherwise. Connect Biopharma claims the protection of the safe harbor for forward-looking statements contained in the Act for all forward-looking statements.

This press release discusses our product candidate, rademikibart, which is under clinical investigation and has not yet been approved for marketing by the U.S. Food and Drug Administration, the National Medical Products Administration, or by any other regulatory agency. No representation is made as to the safety or effectiveness of rademikibart for the uses for which it is being studied. The trademarks included herein are the property of the owners thereof and are used for reference purposes only.

Investor Relations Contact:

Alex Lobo
Precision AQ
Alex.lobo@precisionaq.com
(212) 698-8802

Media Contact:

Ignacio Guerrero-Ros, Ph.D., or David Schull
Russo Partners, LLC
Ignacio.guerrero-ros@russopartnersllc.com
David.schull@russopartnersllc.com
(858) 717-2310 or (646) 942-5604

FAQ

What mechanism‑of‑action data did Connect Biopharma (CNTB) report for rademikibart on Jan 12, 2026?

The company reported enhanced binding affinity to IL‑4R, greater internalization versus dupilumab, and improved β‑agonist responsiveness in human airway models.

When will CNTB report topline results from the Phase 1b intravenous rademikibart study?

Topline results from the Phase 1b IV study are expected in Q1 2026.

When are topline data expected for CNTB's Seabreeze STAT asthma and COPD Phase 2 studies?

Topline data from both Seabreeze STAT studies are expected mid‑2026.

How did rademikibart perform versus dupilumab in preclinical human lung experiments according to CNTB?

Rademikibart substantially reversed IL‑13 induced hyporesponsiveness to β‑agonists in hPCLS, whereas dupilumab showed no rescue effect in those experiments.

What is Connect Biopharma's cash position and projected runway reported Jan 12, 2026?

Cash, cash equivalents and short‑term investments were $54.8M as of Sept 30, 2025, and are expected to fund operations into 2027 under current plans.

What implications did CNTB highlight for rademikibart in acute exacerbations of asthma and COPD?

The company highlighted rademikibart's potential as an adjunct to β‑agonists to reverse acute exacerbations and for maintenance therapy based on MOA and preclinical data.