InflaRx Announces Strategy Focused on Capital-Efficient Execution with Izicopan and Near-Term Value Creation

Rhea-AI Summary

InflaRx (Nasdaq: IFRX) is refocusing resources on its oral C5aR inhibitor izicopan, aiming for Phase 2b readiness in hidradenitis suppurativa (HS) and broader inflammation & immunology (I&I) indications. The company is initiating a PK bridging study in China in 2026 to enable expedited PoC studies and is pursuing partner discussions to accelerate development. InflaRx is executing an ~30% workforce reduction, expects a one-time charge of ~$7 million, and says the actions extend its cash runway to mid-2027. A virtual Capital Markets Day is planned for spring 2026.

Positive

• Cash runway extended to mid-2027
• Prioritization of izicopan toward Phase 2b readiness in HS
• Planned PK bridging study in China (2026) to expedite PoC
• Maintains support for BARDA Just Breathe Phase 2 ARDS study

Negative

• ~30% workforce reduction to streamline operations
• One-time charge of approximately $7 million (inventory write-off)
• Significant reduction in Gohibic (vilobelimab) commercial spending
• Third CSU dosing cohort closed due to low enrollment

Key Figures

Workforce reduction 30% Planned headcount cut as part of restructuring

One-time charge $7 million Estimated restructuring and vilobelimab inventory write-off

Single-dose range 3–240 mg First-in-human izicopan study single-dose levels

Multiple-dose range 30–90 mg Izicopan multiple doses (30 mg QD to 90 mg BID for 14 days)

C5a blockade ≥90% Blockade of C5a-induced neutrophil activation over 14-day dosing

Treatment duration HS 4 weeks Izicopan therapy period in HS Phase 2a with ongoing benefit at 8 weeks

PK bridging study timing 2026 Planned izicopan PK bridging study in China

Cash runway guidance mid-2027 Management expectation after restructuring and cost reductions

Market Reality Check

$1.04 Last Close

Volume Volume 395,465 is below the 20-day average of 648,880 (relative volume 0.61). low

Technical Shares trade above the 200-day MA at 1.16, about 56.68% below the 52-week high and 68.71% above the 52-week low.

Peers on Argus

IFRX gained 2.56% while peers showed mixed moves: strong gains in STTK (+19.4%), SRZN (+12.19%) and MGNX (+5.23%), alongside declines in HLVX and XBIT. With no peers in the momentum scanner and no same-day peer headlines, the reaction appears company-specific rather than a coordinated biotech move.

Historical Context

Date	Event	Sentiment	Move	Catalyst
Dec 30	PG trial update	Negative	+0.0%	Terminated Phase 3 PG study showed non-significant primary endpoint despite post-hoc signals.
Dec 11	Drug naming news	Neutral	-2.9%	WHO granted international nonproprietary name izicopan for INF904 with supporting PK/PD data.
Nov 10	Phase 2a results	Positive	+28.5%	Positive Phase 2a HS and CSU data for INF904 with rapid, durable symptom reductions.
Nov 07	Data timing update	Positive	+2.5%	Announcement of upcoming Phase 2a topline data and Q3 2025 financials release timing.
Oct 21	Conference participation	Neutral	+1.5%	Planned participation in Guggenheim healthcare conference and investor meetings.

Pattern Detected

Positive clinical updates on izicopan/INF904 (e.g., Phase 2a data) have previously coincided with strong upside moves, while naming/housekeeping news and mixed vilobelimab updates have seen flat or slightly negative reactions, indicating selective investor focus on core izicopan progress.

Recent Company History

Over the last several months, InflaRx has steadily pivoted attention toward its oral C5aR inhibitor, now called izicopan. Positive Phase 2a data in HS and CSU on Nov 10, 2025 drove a marked move of +28.46%, contrasting with a modest decline after the INN naming news on Dec 11, 2025. Updates on vilobelimab in pyoderma gangrenosum and conference participation produced limited price changes. Today’s restructuring and capital-efficiency strategy further consolidates that earlier shift toward izicopan as the lead value driver.

Market Pulse Summary

The stock moved -9.2% in the session following this news. A negative reaction despite the focus on capital efficiency could fit past divergence patterns, such as flat trading after the pyoderma gangrenosum update. The news concentrates value on izicopan while cutting about 30% of the workforce and taking a $7 million charge, which some might read as balance-sheet driven. With prior upside tied mainly to strong Phase 2a results, any perceived uncertainty around Phase 2b HS design or CSU next steps could amplify downside moves.

Key Terms

pk bridging study medical

"intends to conduct a PK bridging study in China in 2026"

A PK bridging study measures how a drug is absorbed, distributed, metabolized and cleared in the body for a new formulation, dose or patient group and compares those results to earlier studies. Think of it as a short test run that shows whether a slightly different recipe or a new population behaves the same way as the original one. Investors care because positive bridging data can shorten regulatory hurdles, reduce development cost and speed market access, while discrepancies may trigger extra trials and delays.

phase 2b medical

"goal of continuing toward Phase 2b readiness in hidradenitis suppurativa"

Phase 2b is a stage in the development of a new medicine or treatment where researchers test its effectiveness and safety in a larger group of people. This step helps determine whether the treatment works well enough to move forward and if it has manageable side effects, which is important for investors because successful results can lead to potential approval and market opportunity.

phase 2a medical

"Topline Phase 2a data further support the safety profile of izicopan"

Phase 2a is an early stage in testing a new medical treatment or drug, where the main goal is to assess its safety and find the right dosage. For investors, this stage indicates whether the treatment shows initial promise before moving on to larger, more definitive studies; progress here can influence expectations for future development and potential success.

emergency use authorization regulatory

"available for ordering inside the US under its emergency use authorization"

A regulatory emergency use authorization allows a government health agency to temporarily permit the use or sale of a medical product—such as a vaccine, test, or treatment—before full formal approval when there is a public health crisis. For investors, an authorization can rapidly open revenue and market access while carrying higher regulatory and demand risk, like a fast-track pass that speeds a product to customers but may still require further review and can affect a company's valuation and future sales prospects.

c5ar medical

"potential best-in-class C5aR inhibitor and pipeline-in-a-product"

C5aR is a protein on the surface of immune cells that senses and responds to a small immune signaling molecule called C5a; when activated it acts like a doorbell that calls immune cells and ramps up inflammation. It matters to investors because drugs that block or modulate this receptor can reduce harmful inflammation in diseases, so clinical trial results, approvals, or setbacks for C5aR-targeting therapies can materially affect a biotech’s value and market prospects.

monoclonal antibody medical

"vilobelimab, a novel, intravenously delivered, first-in-class, anti-C5a monoclonal antibody"

A monoclonal antibody is a laboratory-made protein designed to recognize and attach to a specific target in the body, such as a disease-causing substance or cell. It functions like a highly precise lock-and-key tool, helping to treat or detect illnesses. For investors, companies developing monoclonal antibodies can represent promising opportunities in the healthcare sector, especially as these treatments often address unmet medical needs.

pharmacokinetic / pharmacodynamic medical

"Pharmacokinetic / pharmacodynamic data support the best-in-class potential of izicopan"

Pharmacokinetics (PK) describes how a drug moves through the body — how it is absorbed, distributed, broken down and removed — while pharmacodynamics (PD) describes what the drug does to the body and how strong or long the effect is. Together they tell investors whether a medicine can reach the right level in the body safely and produce a reliable benefit, similar to knowing a car’s fuel efficiency (PK) and how well it accelerates (PD), which affect performance, safety and commercial potential.

urticaria activity score (uas7) medical

"reductions in the 7-day Urticaria Activity Score (UAS7) broadly across patients"

A 7-day numeric score that measures the severity of hives and itching by adding daily ratings to produce a single number from 0 (no symptoms) to 42 (worst symptoms). Think of it as a week-long symptom report card used in clinical trials and medical practice to show whether a treatment meaningfully reduces discomfort. Investors care because changes in UAS7 are common regulatory and trial endpoints that drive drug approval, labeling and commercial prospects.

AI-generated analysis. Not financial advice.

• InflaRx to prioritize izicopan as its leading pipeline asset, with a goal of continuing toward Phase 2b readiness in hidradenitis suppurativa (HS)
• To broaden signal-finding activities for izicopan in additional I&I (inflammation and immunology) indications, InflaRx intends to conduct a PK bridging study in China in 2026 to enable expedited proof of concept studies in China and additional geographies
• Toward the goal of fast-tracking izicopan development across all applicable I&I indications, InflaRx continues its concurrent strategy to foster discussions with potential collaborators
• InflaRx is executing an approximately 30% workforce reduction, leading to a significant reduction of the Company’s cost structure, and extension of its cash runway to mid-2027
• The Company intends to host a virtual Capital Markets Day to highlight the clinical utility and commercial potential of izicopan in HS and I&I broadly in spring 2026
  

JENA, Germany, Jan. 08, 2026 (GLOBE NEWSWIRE) -- InflaRx N.V. (Nasdaq: IFRX), a biopharmaceutical company pioneering anti-inflammatory therapeutics by targeting the complement system, today announced it is undertaking measures to reduce spending, extend the Company’s cash runway, and align resources to enable further development of izicopan in HS and other I&I indications as a potential best-in-class C5aR inhibitor and pipeline-in-a-product.

Prof. Niels C. Riedemann, Chief Executive Officer and Founder of InflaRx, commented: “In an effort to enable the long-term success of InflaRx we have made the decision to increase our capital efficiency and tightly focus the Company. Our goal with this realignment is to prioritize resources toward izicopan in hidradenitis suppurativa and additional areas in inflammation and immunology, allowing us to maximize its value as a significantly differentiated oral inhibitor of C5aR and pipeline-in-a-product. We are very optimistic about our strategy and the sizable potential of izicopan, and look forward to reporting additional progress during the year.”

Restructuring and reduction in Gohibic (vilobelimab) spending
As part of its strategic focusing, InflaRx is streamlining its organizational structure and largely discontinuing non-essential activities outside the development of izicopan. These actions are designed to sharpen the Company’s strategic execution, concentrate resources on its highest-value asset, and materially improve capital efficiency.

InflaRx has initiated a workforce reduction of approximately 30% and substantial spending reductions, including significant reductions in Gohibic (vilobelimab) commercial spending and related functions. The Company estimates these activities will result in a one-time charge of approximately $7 million. The majority of this charge will be a non-cash charge related to the write-off of vilobelimab inventory, with a smaller portion associated with the restructuring, including personnel-related costs and the termination or modification of certain third-party contracts. Upon completion, InflaRx expects a significantly leaner cost structure, enabling substantial and sustained reductions in operating expenses and a meaningful extension of its cash runway to mid-2027.

InflaRx will maintain the operational capability needed to support the ongoing BARDA “Just Breathe” Phase 2 clinical platform study in ARDS and does not expect these actions to negatively impact the trial. InflaRx will keep Gohibic (vilobelimab) available for ordering inside the US under its emergency use authorization and maintain the ability to satisfy Gohibic (vilobelimab) demand in the US on a reactive basis.

InflaRx will continue to review partnering opportunities for Gohibic in the US and Europe. In addition, as previously disclosed, the Company anticipates meeting with the FDA to determine a potential development path forward for vilobelimab in pyoderma gangrenosum, which it anticipates would only be conducted in collaboration with a partner.

Enabling broader development with izicopan (INF904) in I&I
Given data demonstrating its advantageous PK/PD profile, meaningful differentiation as an inhibitor of the C5a/C5aR axis, and potential to address HS, chronic spontaneous urticaria (CSU) and other I&I indications, the Company will prioritize resource allocation and clinical development toward izicopan while continuing active dialog with potential partners across all geographies to expedite and maximize value.

In HS InflaRx continues to make progress toward Phase 2b readiness. InflaRx is in active dialogue with the FDA related to the Phase 2b study design and potential endpoints. The aim is to align on a development path and endpoints expected to meaningfully differentiate izicopan from existing therapies, while also addressing variability inherent in some HS trial outcomes. InflaRx is moving as quickly as is feasible in this effort and intends to provide an update on its HS Phase 2b planning and readiness in due course.

InflaRx sees significant potential for izicopan to address unmet needs in multiple I&I indications beyond HS, including CSU, where InflaRx continues data analysis and active dialog with thought leaders to determine next steps. Given the supportive nature of the Phase 2a data collected to-date from the two main CSU (all-comer) dosing cohorts, and low enrollment trends in the third (anti-IgE refractory) dosing cohort, InflaRx has decided to close the third treatment cohort. InflaRx will utilize the existing data set to determine next steps for izicopan in CSU, which the Company expects to communicate later this year.

InflaRx intends to submit the izicopan Phase 2a datasets in HS and CSU for presentation at medical conferences later this year.

Toward the goal of generating proof of concept data in additional I&I indications as efficiently as possible, InflaRx intends to conduct a PK bridging study with izicopan in China this year in order to expedite subsequent proof of concept studies in China and elsewhere. The Company intends to provide an update on these efforts, and on efforts in additional potential I&I indications, later this year.

Capital Markets Day
InflaRx expects to host a virtual capital markets day this spring. During this event the Company plans to highlight the clinical utility of izicopan in HS and I&I more broadly, including izicopan’s role in respective I&I treatment algorithms, and its emerging commercial potential.

About izicopan
Izicopan (INF904) is an orally administered, small molecule inhibitor of the C5a receptor Ca5R1 that has shown anti-inflammatory therapeutic effects in several pre-clinical disease models and in human studies. Further, in contrast to the marketed C5aR inhibitor, in vitro experiments demonstrated that izicopan has minimal inhibition of the cytochrome P450 3A4/5 (CYP3A4/5) enzymes, which play an important role in the metabolism of a variety of metabolites and drugs, including glucocorticoids. Reported results from a first-in-human study demonstrated that izicopan was well tolerated in treated subjects and exhibited no safety signals of concern in single doses ranging from 3 mg to 240 mg or multiple doses ranging from 30 mg once per day to 90 mg twice per day for 14 days. Pharmacokinetic / pharmacodynamic data support the best-in-class potential of izicopan, with a ≥90% blockade of C5a-induced neutrophil activation achieved over the 14-day dosing period. Topline Phase 2a data further support the safety profile of izicopan, with no reported safety signals of concern. In patients with hidradenitis suppurativa, over 4 weeks of therapy, izicopan provided rapid and clinically meaningful reductions in abscesses and nodules (ANs) and draining tunnels (dTs), robust HiSCR responses that continued to deepen four weeks after the treatment period, and substantial reductions in patient-reported pain scores, overall demonstrating the potential for biologic-like efficacy. In chronic spontaneous urticaria, InflaRx observed substantial reductions in the 7-day Urticaria Activity Score (UAS7) broadly across patients and particularly in those with severe disease, as well as improved disease control as measured by the Urticaria Control Test (UCT7).

About InflaRx N.V.
InflaRx (Nasdaq: IFRX) is a biopharmaceutical company pioneering anti-inflammatory therapeutics by applying its proprietary anti-C5a and anti-C5aR technologies to discover, develop and commercialize highly potent and specific inhibitors of the complement activation factor C5a and its receptor, C5aR. C5a is a powerful inflammatory mediator involved in the progression of a wide variety of inflammatory diseases. InflaRx‘s lead program is izicopan (INF904), an orally administered small molecule inhibitor of C5a-induced signaling via the C5a receptor, which has shown promising PK/PD characteristics as well as therapeutic potential in Phase 1 and Phase 2a clinical studies. The company is developing izicopan for the treatment of several inflammatory diseases, including hidradenitis suppurativa (HS). The Company has also developed vilobelimab, a novel, intravenously delivered, first-in-class, anti-C5a monoclonal antibody that selectively binds to free C5a and has demonstrated disease-modifying clinical activity and tolerability in multiple clinical studies.

InflaRx was founded in 2007, and the group has offices and subsidiaries in Jena and Munich, Germany, as well as Ann Arbor, MI, USA. For further information, please visit www.inflarx.de. InflaRx GmbH (Germany) and InflaRx Pharmaceuticals Inc. (USA) are wholly owned subsidiaries of InflaRx N.V. (together, InflaRx).

Contacts:

InflaRx N.V.	MC Services AG
Jan Medina, CFA Vice President, Head of Investor Relations Email: IR@inflarx.de	Katja Arnold, Laurie Doyle, Dr. Regina Lutz Email: inflarx@mc-services.eu Europe: +49 89-210 2280 U.S.: +1-339-832-0752

FORWARD-LOOKING STATEMENTS
This press release contains forward-looking statements. All statements other than statements of historical fact are forward-looking statements, which are often indicated by terms such as “may,” “will,” “should,” “expect,” “plan,” “anticipate,” “could,” “intend,” “target,” “estimate,” “believe,” “predict,” “potential” or “continue,” among others. Forward-looking statements appear in a number of places throughout this press release and may include statements regarding our intentions, beliefs, projections, outlook, analyses and current expectations concerning, among other things: the receptiveness of izicopan as a treatment for HS and CSU by patients and hospitals and related treatment recommendations by medical/healthcare institutes and other third-party organizations; our ability to successfully secure distribution channels and commercialize GOHIBIC (vilobelimab) as a treatment for COVID-19 patients and our ability to positively influence treatment recommendations by U.S. and European hospitals, guideline bodies and other third-party organizations; our expectations regarding the size of the patient populations for, market opportunity for, coverage and reimbursement for, estimated returns and return accruals for, and clinical utility of GOHIBIC (vilobelimab) in its approved or authorized indication or for vilobelimab and any other product candidates, under the Emergency Use Authorization and in the future if approved for commercial use in the United States, Europe or elsewhere; our ability to successfully implement The InflaRx Commitment Program, the success of our future clinical trials for vilobelimab’s treatment of debilitating or life-threatening inflammatory indications, including acute respiratory distress syndrome and other indications, and any other product candidates, including izicopan, and whether such clinical results will reflect results seen in previously conducted pre-clinical studies and clinical trials; the timing, progress and results of pre-clinical studies and clinical trials of vilobelimab, izicopan and any other product candidates, including for the development of vilobelimab in several indications, including to obtain full approval of GOHIBIC (vilobelimab) for COVID-19 and other virally induced ARDS, to treat HS and CSU, and statements regarding the timing of initiation and completion of studies or trials and related preparatory work, the period during which the results of the trials will become available, the costs of such trials and our research and development programs generally; our interactions with and the receptiveness and approval by regulators regarding the results of clinical trials and potential regulatory approval or authorization pathways, including our biologics license application submission for GOHIBIC (vilobelimab); the timing and outcome of any discussions or submission of filings for regulatory approval or authorization of vilobelimab, izicopan or any other product candidate, and the timing of and our ability to obtain and maintain full regulatory approval, the EUA and/or market authorization of vilobelimab or GOHIBIC (vilobelimab) for any indication; our ability to leverage our proprietary anti-C5a and anti-C5a receptor technologies to discover and develop therapies to treat complement-mediated autoimmune and inflammatory diseases; our ability to protect, maintain and enforce our intellectual property protection for vilobelimab, izicopan and any other product candidates, and the scope of such protection; whether the U.S. Food and Drug Administration, the European Medicines Agency or any comparable foreign regulatory authority will accept or agree with the number, design, size, conduct or implementation of our clinical trials, including any proposed primary or secondary endpoints for such trials; the success of our future clinical trials for vilobelimab, izicopan and any other product candidates and whether such clinical results will reflect results seen in previously conducted pre-clinical studies and clinical trials; our expectations regarding the size of the patient populations for, the market opportunity for, the medical need for and clinical utility of vilobelimab, izicopan or any other product candidates, if approved or authorized for commercial use; our manufacturing capabilities and strategy, including the scalability and cost of our manufacturing methods and processes and the optimization of our manufacturing methods and processes, and our ability to continue to rely on our existing third-party manufacturers and our ability to engage additional third-party manufacturers for our planned future clinical trials and for commercial supply of vilobelimab and for the finished product GOHIBIC (vilobelimab) in the United States and Europe; our estimates of our expenses, ongoing losses, future revenue, capital requirements and our needs for or ability to obtain additional financing; our expectations regarding the scope of any approved indication for vilobelimab; our ability to defend against liability claims resulting from the testing of our product candidates in the clinic or, if approved or authorized, any commercial sales; if any of our product candidates obtain regulatory approval or authorization, our ability to comply with and satisfy ongoing drug regulatory obligations and continued regulatory overview; our ability to comply with enacted and future legislation in seeking marketing approval or authorization and commercialization; our future growth and ability to compete, which depends on our retaining key personnel and recruiting additional qualified personnel; our competitive position and the development of and projections relating to our competitors in the development of C5a and C5aR inhibitors and other therapeutic products being developed in similar medical conditions in which vilobelimab, izicopan or any other of our product candidates is being developed or our industry; and the risks, uncertainties and other factors described under the heading “Risk Factors” in our periodic filings with the U.S. Securities and Exchange Commission. These statements speak only as of the date of this press release and involve known and unknown risks, uncertainties and other important factors that may cause our actual results, performance or achievements to be materially different from any future results, performance or achievements expressed or implied by the forward-looking statements. Given these risks, uncertainties and other factors, you should not place undue reliance on these forward-looking statements, and we assume no obligation to update these forward-looking statements, even if new information becomes available in the future, except as required by law.

FAQ

What development priority did InflaRx announce for izicopan (IFRX) on January 8, 2026?

InflaRx said it will prioritize izicopan as its lead asset, progressing toward Phase 2b readiness in HS and exploring additional I&I indications.

How does InflaRx plan to extend IFRX's cash runway after the January 8, 2026 restructuring?

By reducing spending, cutting ~30% of its workforce, trimming Gohibic commercial costs, and taking a one-time charge of ~$7M, extending runway to mid-2027.

Will InflaRx run izicopan studies in China for IFRX, and when?

Yes. InflaRx intends to conduct a PK bridging study in China in 2026 to enable expedited proof-of-concept trials there and elsewhere.

What changes did InflaRx announce for its Gohibic (vilobelimab) program on January 8, 2026?

The company said it is substantially reducing Gohibic commercial spending, keeping US emergency-use supply available, and seeking partners for US and Europe.

Did InflaRx change any CSU study cohorts for izicopan in the January 2026 update?

Yes. InflaRx closed the third CSU dosing cohort due to low enrollment and will analyze existing data to determine next steps.

When will InflaRx present more detail about izicopan's clinical and commercial plans for IFRX?

InflaRx plans a virtual Capital Markets Day in spring 2026 to highlight izicopan's clinical utility and commercial potential.