InflaRx N.V. (IFRX) Business Model Canvas

InflaRx N.V. (IFRX): Business Model Canvas [Dec-2025 Updated]

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You're digging into InflaRx N.V.'s strategy as they navigate the tricky transition from pure R&D to commercialization, and honestly, the numbers tell a clear story. As of mid-2025, the firm held €53.7 million in cash, but you see the burn rate with €14.2 million spent on Research and Development (R&D) alone in the first half of the year, while product sales for GOHIBIC were just €39 thousand in H1 2025. This Business Model Canvas breaks down exactly how InflaRx N.V. is balancing its proprietary anti-C5a/C5aR complement system technology platform, the EU marketing authorization for vilobelimab, and the critical need for EU distribution partners against that heavy cost structure. Let's map out the nine blocks so you can see where the near-term risks and opportunities truly lie below.

InflaRx N.V. (IFRX) - Canvas Business Model: Key Partnerships

You're looking at how InflaRx N.V. structures its external relationships to drive development and commercialization, which is critical given its cash position of approximately €53.7 million as of June 30, 2025, supporting operations into 2027.

Biomedical Advanced Research and Development Authority (BARDA) Funding for ARDS Trial

The relationship with the Biomedical Advanced Research and Development Authority (BARDA) is a key non-dilutive funding mechanism for the ARDS program. In June 2025, BARDA selected GOHIBIC (vilobelimab) for inclusion in its JUST BREATHE Phase 2 platform clinical trial, which explores novel host-directed therapeutics for Acute Respiratory Distress Syndrome (ARDS).

This trial is designed to evaluate GOHIBIC alongside two other investigational therapies. The structure is quite specific, aiming for robust data collection in a critical care setting where no therapy is currently approved. The trial began enrollment in June 2025.

  • BARDA contracted PPD (Thermo Fisher Scientific) to implement the trial.
  • The trial targets a total enrollment of 600 hospitalized adult patients with ARDS.
  • The study is set to run at up to 60 U.S. sites.
  • GOHIBIC will be studied in its own cohort of 200 patients (half receiving the drug, half placebo).
  • The primary endpoint for the GOHIBIC cohort is all-cause mortality at Day 28.

Staidson BioPharmaceuticals Co-Development in China

InflaRx N.V. has a long-standing co-development agreement with Staidson BioPharmaceuticals for BDB-001, which is an anti-C5a antibody derived from the same vilobelimab cell line. Staidson is responsible for development and manufacturing in China. This partnership has seen favorable Phase 1/2 data for BDB-001 in ANCA-associated vasculitis (AAV), leading Staidson to plan for a Phase 3 study initiation.

The financial structure involves InflaRx granting Staidson an exclusive license for China, in exchange for royalties. Furthermore, an equity investment component was part of the December 2022 addendum, where Staidson made an initial investment of $2,500,000 for 500,000 ordinary shares at $5.00 per share, with an option for a further $7,500,000 investment.

Partnership Aspect Product/Indication Financial/Statistical Detail
Royalty Rate (COVID-19 in China) BDB-001 10% on net sales
Royalty Rate (AAV in China) BDB-001 Mid-single-digit percentage on future net sales
Initial Equity Investment Staidson Affiliate $2,500,000 for 500,000 shares
Potential Further Equity Investment Staidson Affiliate Option for an additional $7,500,000

WuXi Biologics as Contract Manufacturing Partner

WuXi Biologics serves as the critical contract manufacturing partner, providing cGMP (current Good Manufacturing Practice) manufacturing for GOHIBIC (vilobelimab). This collaboration is essential for InflaRx N.V. to support supply for approved markets and clinical trials, leveraging WuXi Biologics' global manufacturing network and dual-sourcing strategy.

While the partnership is foundational for supply chain stability, specific per-unit manufacturing cost data isn't public, but the operational focus is on ramping up production to serve the patient population.

PPD (Thermo Fisher Scientific) Implementation of BARDA Trial

The execution of the BARDA-funded JUST BREATHE trial is managed by PPD Development, LP, which is the clinical research business of Thermo Fisher Scientific, Inc. PPD is contracted directly by BARDA to manage the complex, multicenter study. This outsourcing transfers significant operational burden for trial logistics.

The scale of the operation managed by PPD is substantial, involving significant site management and patient coordination. The trial is designed to enroll patients across as many as 60 U.S. sites.

Seeking EU Commercial Partnering for GOHIBIC

InflaRx N.V. is actively pursuing commercial partnering and distribution options for GOHIBIC in the European Union (EU). GOHIBIC received marketing authorization under exceptional circumstances from the European Commission in January 2025 for treating SARS-CoV-2-induced ARDS.

The company has explicitly stated that this partnering approach is not expected to materially negatively impact its cash burn rate, suggesting a preference for a lower-cost, milestone/royalty-based commercialization model over self-commercialization in the EU for this indication. The EU authorization is valid across all 27 EU member states plus Iceland, Liechtenstein, and Norway.

  • GOHIBIC is the first and only treatment approved in the EU for SARS-CoV-2-induced ARDS.
  • The EU approval is supported by the Phase 3 PANAMO trial data.
  • The company's current cash runway extends into 2027.

InflaRx N.V. (IFRX) - Canvas Business Model: Key Activities

You're looking at the core engine room of InflaRx N.V. (IFRX), the activities that consume capital and drive potential value inflection points. For a company at this stage, Key Activities revolve around clinical execution and shoring up the balance sheet to fund the next data readout. Here's the quick math on what they've been doing.

Research and Development (R&D) for INF904 (oral C5aR inhibitor)

The focus here is moving the oral candidate, INF904, through proof-of-concept studies. InflaRx N.V. completed the necessary sub-chronic and chronic toxicology studies for INF904, which supports the potential for long-term dosing in future clinical efforts. To be fair, the market potential is significant; InflaRx believes Chronic Spontaneous Urticaria (CSU) and Hidradenitis Suppurativa (HS) each represent addressable markets of $1 billion or more for INF904. The financial commitment to this pipeline segment is clear in the expense reports.

Research and development expenses for the six months ended June 30, 2025, totaled €14.2 million. This reflects the ongoing investment required to advance this small molecule inhibitor of C5a-induced signaling.

Managing and executing clinical trials (e.g., INF904 Phase 2a, BARDA-funded ARDS trial)

Clinical trial management is a massive activity, especially with multiple programs running concurrently. The Phase 2a basket trial for INF904 is a key near-term catalyst. This study is evaluating multiple dosing regimens over 4 weeks of treatment in a total of 75 patients, split between 45 with CSU and 30 with HS. The goal is to have topline data ready for announcement between the end of September and early November 2025, which will then inform the planning and design of a larger, longer-term Phase 2b study by year-end 2025.

For the intravenous vilobelimab program, the Phase 3 trial in Pyoderma Gangrenosum (PG) was a major activity that concluded in 2025. The Independent Data Monitoring Committee (IDMC) recommended the trial be stopped due to futility in May 2025, after reaching the 30-patient recruitment milestone necessary for the interim analysis. Also active is the BARDA-funded JUST BREATHE Phase 2 platform clinical trial for Acute Respiratory Distress Syndrome (ARDS), which targets a total enrollment of 600 hospitalized adult patients across up to 60 U.S. sites.

Here's a snapshot of the clinical trial status as of mid-2025:

Program Indication Key Status/Milestone Expected Readout/Action
INF904 (Oral) CSU & HS Phase 2a trial with 75 patients Topline data expected by early November 2025
Vilobelimab (IV) Pyoderma Gangrenosum (PG) Phase 3 trial stopped due to futility Data analysis/unblinding later in 2025
Vilobelimab (IV) ARDS Enrollment began in BARDA-funded Phase 2 trial Ongoing, targeting 600 patients

Commercialization and distribution of GOHIBIC (vilobelimab) in the US and EU

While clinical development is the main spend, InflaRx N.V. must manage the commercial footprint for GOHIBIC (vilobelimab), which already has EU marketing authorization. The activity of selling the product in the US is reflected in the revenue and associated expenses. Honestly, the current commercial revenue is minimal compared to R&D spend, which is typical for a pre-commercial biotech.

For the six months ended June 30, 2025, the company realized revenues of €39 thousand from GOHIBIC sales, all attributed to the United States. This was a slight decrease of €3 thousand compared to the same period in 2024. Correspondingly, sales and marketing expenses for that six-month period decreased by €0.8 million year-over-year to €2.5 million, partly due to in-sourcing sales staff.

Protecting and expanding proprietary anti-C5a/C5aR intellectual property

This activity is about securing future value through partnerships and technology application. InflaRx N.V. is applying its proprietary anti-C5a and anti-C5aR technologies across its pipeline. A key external validation point came from its collaborator, Staidson BioPharmaceuticals, which reported positive Phase 1/2 data for the partnered anti-C5a antibody BDB-001 in ANCA-associated vasculitis (AAV) in July 2025, leading to Staidson planning a Phase 3 study. Under that co-development deal, InflaRx N.V. is set to receive royalties on future AAV sales.

Investor relations and capital raising, like the €28.7 million public offering in February 2025

Keeping the lights on and funding the pipeline requires constant engagement with capital markets. A critical recent activity was the completion of an underwritten public offering in February 2025, which brought in gross proceeds of €28.7 million (or $30.0 million) before fees. This financing was explicitly intended to fund clinical development for vilobelimab and INF904, among other general corporate purposes. The impact on the balance sheet is clear: Net cash from financing activities increased by €27.1 million in the first half of 2025 due to this offering. As of June 30, 2025, the company reported total funds available of approximately €53.7 million, which management estimates provides a cash runway into 2027.

Key financial metrics related to funding and operational burn for the first half of 2025 include:

  • Cash, cash equivalents and marketable securities as of June 30, 2025: €53.7 million.
  • Net cash used in operating activities for the six months ended June 30, 2025: €21.6 million.
  • General and administrative expenses for the six months ended June 30, 2025: €8.3 million, up by €1.5 million year-over-year.

InflaRx N.V. (IFRX) - Canvas Business Model: Key Resources

You're looking at the core assets InflaRx N.V. relies on to drive its pipeline forward, especially given the recent capital raise in February 2025. These resources are what back their strategy to target severe inflammatory diseases.

Proprietary anti-C5a and anti-C5aR complement system technology platform.

InflaRx N.V. applies its proprietary technology to discover and develop potent and specific inhibitors targeting the complement activation factor C5a and its receptor C5aR. C5a is a key inflammatory mediator in many autoimmune and inflammatory diseases. This platform is the scientific foundation for their entire pipeline.

Vilobelimab (GOHIBIC), a first-in-class anti-C5a monoclonal antibody.

This is the company's lead product candidate, a novel, intravenously delivered, first-in-class anti-C5a monoclonal antibody. It selectively binds to free C5a. A significant recent milestone was the European Commission granting marketing authorization under exceptional circumstances for GOHIBIC (vilobelimab) in January 2025 for treating adult patients with SARS-CoV-2-induced acute respiratory distress syndrome (ARDS) who are on systemic corticosteroids.

INF904, a potentially best-in-class oral C5aR inhibitor.

INF904 is an orally administered small molecule inhibitor of the C5a receptor, positioned as a potentially best-in-class agent. The company believes CSU and HS each represent potential addressable markets of $1 billion or more for INF904. Data from the Phase 2a trial for INF904 in chronic spontaneous urticaria and hidradenitis suppurativa was anticipated by early November 2025.

Cash, cash equivalents, and marketable securities totaling €53.7 million as of June 30, 2025.

The balance sheet strength, bolstered by a public offering in February 2025 that brought in gross proceeds of €28.7 million ($30.0 million), supports operations. The company estimates this financial position provides sufficient funds for currently planned operations into 2027. Here's the quick math on the liquidity as of the mid-year point:

Financial Component Amount as of June 30, 2025 (in €)
Total Cash, Cash Equivalents and Marketable Securities €53.7 million
Cash and Cash Equivalents €13.0 million
Marketable Securities €40.7 million

What this estimate hides is the net cash used in operating activities for the first six months of 2025, which was €21.6 million.

Specialized R&D personnel and clinical development expertise.

The operational and research & development hub is located at the headquarters in Jena, Germany. This location is significant because Jena is a German center for optics, life sciences, and research, giving InflaRx N.V. access to a skilled talent pool and opportunities for collaboration with local institutions. The team's expertise centers on applying the complement platform across multiple pipeline programs, including the Phase 3 trial for vilobelimab in pyoderma gangrenosum (PG) and the Phase 2a trials for INF904.

The key personnel focus is on advancing these specific assets:

  • Advancing vilobelimab through the adaptive design Phase 3 trial in PG.
  • Executing the clinical development plan for INF904 in CSU and HS.
  • Managing the BARDA-funded JUST BREATHE Phase 2 platform trial for ARDS with vilobelimab.
  • Overseeing clinical trial management and drug discovery from the Jena HQ.

Finance: draft 13-week cash view by Friday.

InflaRx N.V. (IFRX) - Canvas Business Model: Value Propositions

You're looking at the core value InflaRx N.V. is trying to deliver across its pipeline, which centers on blocking the complement system, a key driver in inflammation. The value propositions are split between an already-approved therapy for a critical, acute condition and a promising oral candidate for chronic diseases.

First-in-class anti-C5a therapy (GOHIBIC) for life-threatening inflammatory conditions.

GOHIBIC (vilobelimab) holds a significant, albeit niche, value proposition as the first and only treatment approved in the European Union for a specific life-threatening condition. This approval was granted by the European Commission on January 15, 2025, under exceptional circumstances.

The value is grounded in clinical benefit data from the Phase 3 PANAMO trial:

  • Reduced 28-day all-cause mortality by 23.9% compared to placebo in the target population.
  • Indicated for adult patients with SARS-CoV-2-induced ARDS receiving systemic corticosteroids and invasive mechanical ventilation (IMV) with or without ECMO.

However, the commercial uptake is currently limited. For the six months ended June 30, 2025, InflaRx N.V. realized only €39 thousand in revenues from GOHIBIC (vilobelimab) sales. The cost structure is heavy, with the company reporting a gross loss of €2,345,945 for the nine months ended September 30, 2025, despite some revenue.

Oral, small-molecule C5aR inhibitor (INF904) with potential best-in-class profile.

INF904 is positioned as a potentially best-in-class oral, small-molecule C5aR1 inhibitor, designed to block C5a-induced signaling and downstream neutrophil activation. This contrasts with a marketed C5aR inhibitor where preclinical data suggested INF904 offered ~3-fold higher Cmax and ~10-fold higher AUClast.

Key data points supporting its profile include:

Parameter Result Context
C5a Blockade ≥90% blockade of C5a-induced neutrophil activation Achieved over a 14-day dosing period in first-in-human studies
CYP3A4/5 Interaction Minimal inhibition A differentiation point versus the marketed C5aR inhibitor
Phase 2a Safety No safety signals of concern reported Across 33 HS patients and 33 CSU patients in the basket trial

The company is planning to advance this asset into Phase 2b development for HS.

Addressing high unmet medical needs in rare and severe inflammatory diseases like HS and CSU.

InflaRx N.V. sees significant market potential in the chronic inflammatory diseases targeted by INF904. The company believes both Hidradenitis Suppurativa (HS) and Chronic Spontaneous Urticaria (CSU) represent potential addressable markets of $1 billion or more each for INF904.

The November 2025 topline data from the Phase 2a trial provided exploratory efficacy signals in these indications:

  • CSU: The 60-mg dose cohort showed the greatest improvement, with a mean absolute reduction in the 7-day Urticaria Activity Score (UAS7) of -13.7 points at week 4.
  • CSU Severe Subgroup: In patients with severe CSU at baseline (n = 23), the 60-mg dose reduced UAS7 by 15.4 points.
  • HS: The 120 mg dose was reported as the most effective in reducing abscesses, nodules, and draining tunnels.

The company is working toward initiating Phase 2b development in HS in 2026.

GOHIBIC's EU marketing authorization for SARS-CoV-2-induced ARDS under exceptional circumstances.

The EU marketing authorization for GOHIBIC (vilobelimab) was granted by the European Commission on January 15, 2025. This authorization is under exceptional circumstances, reflecting the difficulty in obtaining complete data due to the declining phase of the COVID-19 pandemic at the time of authorization.

The authorization is for the treatment of adult patients with SARS-CoV-2-induced ARDS who meet specific criteria:

  • Receiving systemic corticosteroids as part of standard of care.
  • Receiving invasive mechanical ventilation (IMV) with or without extracorporeal membrane oxygenation (ECMO).

The approval obligates InflaRx N.V. to provide annual updates to the EMA on ongoing studies, including the BARDA-funded JUST BREATHE Phase 2 platform study investigating ARDS treatments.

InflaRx N.V. (IFRX) - Canvas Business Model: Customer Relationships

You're managing relationships in a clinical-stage biotech, so the focus is heavily weighted toward scientific credibility and future commercial reach. For InflaRx N.V. (IFRX) as of late 2025, customer relationships center on securing expert validation, establishing distribution channels, and maintaining investor confidence through transparency.

High-touch engagement with key opinion leaders (KOLs) and specialized physicians

Engagement with Key Opinion Leaders (KOLs) is critical for validating clinical progress, especially following the readout of the INF904 Phase 2a trial data, which was discussed on a November 10, 2025, webcast featuring key opinion leader insight. The foundational relationship with the medical community was established through clinical work; for instance, the marketing authorization for GOHIBIC in the EU was supported by the PANAMO study, for which InflaRx N.V. expressed gratitude for the support provided by intensive care physicians who participated. This high-touch approach is necessary to build the foundation for future adoption in indications like hidradenitis suppurativa (HS) and chronic spontaneous urticaria (CSU), where the addressable markets for INF904 are each estimated at $1 billion or more.

The nature of these relationships is demonstrated by the specific events and data points shared with the medical community:

  • Topline data from the Phase 2a clinical trial of INF904 was reported on November 10, 2025.
  • The company is developing vilobelimab (GOHIBIC) and INF904 for rare and severe inflammatory disorders.
  • The company maintains offices in Jena and Munich, Germany, as well as Ann Arbor, MI, USA, supporting a global footprint for collaboration with academic institutions and KOLs across Europe and North America.

Strategic commercial partnering focus for GOHIBIC distribution in the EU

Following the European Commission (EC) granting marketing authorization under exceptional circumstances for GOHIBIC (vilobelimab) in January 2025, the relationship focus shifted to securing commercial distribution. GOHIBIC is the first and only treatment approved in the European Union for SARS-CoV-2-induced ARDS. The authorization covers all 27 EU member states as well as Iceland, Liechtenstein, and Norway. InflaRx N.V. is actively considering commercial partnering and distribution options in the EU, a strategy they noted would not have a materially negative impact on their cash burn rate. This partnering effort is key to scaling access beyond the initial sales, which for the six months ended June 30, 2025, amounted to €39 thousand in revenues from GOHIBIC sales, a decrease of €3 thousand compared to the same period in 2024.

Here's a snapshot of the EU commercial status and partnering strategy as of late 2025:

Metric Value/Status
EU Marketing Authorization Date (GOHIBIC) January 2025
Geographic Coverage 27 EU member states, Iceland, Liechtenstein, and Norway
Distribution Strategy Considering commercial partnering
GOHIBIC Sales (6M Ended June 30, 2025) €39 thousand
Cash Runway Projection Into 2027

Direct, specialized communication with investors via conferences and one-on-one meetings

InflaRx N.V. maintains direct communication with investors, often timed around key data releases. For example, the Q3 2025 financial results and topline data for INF904 were discussed on a webcast on November 10, 2025. The company's investor relations is managed by Jan Medina, CFA Vice President, Head of Investor Relations. The company actively engages through scheduled events, such as in March 2025, when they participated in two investor conferences, both including one-on-one-investor meetings.

Specific investor engagement activities in 2025 included:

  • Participation in Leerink Global Healthcare Conference (March 9 - 12, 2025) with a fireside chat on March 10 at 10:40 AM ET.
  • Participation in H.C. Wainwright 3rd Annual Autoimmune & Inflammatory Disease Virtual Conference on March 27, 2025, with a fireside chat at 8:30 AM ET.
  • Reporting Q1 2025 results on May 7, 2025.
  • Reporting Q2 2025 results on August 7, 2025.

Financially, the company bolstered its position to support these ongoing relationships and development programs by raising gross proceeds of €28.7 million ($30.0 million) in February 2025 through an offering of ordinary shares and pre-funded warrants. This funding helps support operations with a projected cash runway into 2027.

InflaRx N.V. (IFRX) - Canvas Business Model: Channels

You're looking at how InflaRx N.V. gets its product and its message out there as of late 2025. It's a mix of direct engagement where they can control the process and looking for partners where the market is established.

Direct sales to specialized US hospitals for GOHIBIC (vilobelimab)

For GOHIBIC, which holds an Emergency Use Authorization (EUA) in the United States, the channel is direct sales to end customers, meaning hospitals. Sales to distributors don't count as revenue for InflaRx N.V. for reporting purposes. The financial results for the first half of 2025 reflect this direct channel activity.

  • Revenues from GOHIBIC sales in the United States for the six months ended June 30, 2025, totaled €39 thousand.
  • This figure represents a decrease of €3 thousand compared to the same period in 2024.
  • Marketing and sales expenses incurred in the U.S. for the full year 2023 were €4.0 million.

InflaRx N.V. actively encouraged stocking through The InflaRx Commitment Program, which offered to cover the cost of GOHIBIC for eligible patients who died after administration under the EUA in the ICU.

Third-party distributors and commercial partners for EU market access

GOHIBIC received marketing authorization under exceptional circumstances from the European Commission in January 2025. For this market, the strategy is not direct sales but exploring external relationships.

Market Area Commercial Strategy Channel Status/Action as of Late 2025
European Union (EU) Commercial Partnering and Distribution Options InflaRx N.V. continues to pursue these options

The company stated that pursuing this partnering approach is not expected to have a materially negative impact on its cash burn rate.

Global network of clinical trial sites for R&D pipeline advancement

Advancing the pipeline, especially for INF904, relies on a network of clinical sites. This is how InflaRx N.V. gathers the necessary safety, PK, and efficacy data to inform future Phase 2b study designs.

  • The BARDA-funded JUST BREATHE Phase 2 platform clinical trial for ARDS is evaluating vilobelimab and other candidates at up to 60 U.S. sites.
  • The Phase 2a basket study for INF904 in Chronic Spontaneous Urticaria (CSU) and Hidradenitis Suppurativa (HS) involves a total of 75 patients (45 with CSU and 30 with HS) across multiple centers.

Data from this INF904 trial was anticipated by the end of September to early November 2025.

Investor conferences and press releases for capital markets communication

Keeping the capital markets informed is a key channel for a publicly traded company like InflaRx N.V. (Nasdaq: IFRX). This involves direct engagement at industry events and broad communication via press releases.

  • InflaRx N.V. announced participation in two investor conferences in September 2025: the Cantor Global Healthcare Conference (September 3 - 5) and the H.C. Wainwright 27th Annual Global Investment Conference (September 8 - 10).
  • The company also participated in the Guggenheim Securities 2nd Annual Healthcare Innovation Conference in November 2025.
  • Gross proceeds of €28.7 million (or $30.0 million) were subsequently raised via an underwritten public offering of ordinary shares and pre-funded warrants in February 2025.

These communications support the stated cash runway into 2027. Finance: draft 13-week cash view by Friday.

InflaRx N.V. (IFRX) - Canvas Business Model: Customer Segments

You're looking at the specific groups InflaRx N.V. is targeting with its complement-focused pipeline as of late 2025. It's a mix of acute critical care and chronic specialty markets.

Hospitalized adults with SARS-CoV-2-induced ARDS receiving invasive mechanical ventilation (US/EU).

This segment is served by GOHIBIC (vilobelimab), which has European Commission approval for this indication. In the US, enrollment began in the BARDA funded JUST BREATHE Phase 2 platform clinical trial. This trial aims to evaluate candidates at up to 60 U.S. sites, targeting a total enrollment of up to 600 hospitalized adult patients with ARDS.

  • EU Approval: GOHIBIC (vilobelimab) for SARS-CoV-2-induced ARDS on invasive mechanical ventilation.
  • US Trial Enrollment: Started in the BARDA funded JUST BREATHE Phase 2 platform trial.
  • Target Enrollment Size: Up to 600 patients across up to 60 U.S. sites.

Revenues from GOHIBIC sales in the United States for the six months ended June 30, 2025, totaled €39 thousand.

Patients with chronic inflammatory dermatological conditions (Hidradenitis Suppurativa, Chronic Spontaneous Urticaria).

The focus here is on the oral C5aR inhibitor, INF904. The Phase 2a trial involved a total of 75 patients, split between 45 with Chronic Spontaneous Urticaria (CSU) and 30 with Hidradenitis Suppurativa (HS). Data informing Phase 2b planning is expected by year-end 2025.

Indication Product Candidate Estimated Addressable Market (Each)
Chronic Spontaneous Urticaria (CSU) INF904 $1 billion or more
Hidradenitis Suppurativa (HS) INF904 $1 billion or more

Specialized physicians and hospital procurement groups treating severe inflammatory disorders.

These groups are the decision-makers and prescribers for GOHIBIC in the EU and potential future products like INF904. The ARDS trial itself involves up to 60 U.S. sites, indicating a segment of specialized investigators and associated procurement channels. The company's cash position as of June 30, 2025, was €53.7 million, funding operations into 2027.

  • US ARDS Trial Sites: Up to 60 sites involved in the JUST BREATHE trial.
  • Cash Runway: Sufficient funds for currently planned operations into 2027.
  • Market Capitalization: $82.57M as of November 7, 2025.

Global biopharma partners seeking C5a/C5aR assets for co-development.

This segment is represented by existing collaborations and the potential for future deals on pipeline assets. Staidson BioPharmaceuticals is a current partner, advancing the InflaRx-partnered C5a antibody BDB-001, with Phase 3 study initiation expected. InflaRx continues to assess the value of pursuing additional applications via potential future collaborations. The company incurred a net loss of €23.0 million for the six months ended June 30, 2025.

The structure of the partnership with Staidson BioPharmaceuticals involves advancing BDB-001 in ANCA-associated vasculitis (AAV) to a Phase 3 study. The company's revenues for the three months ended September 30, 2025, were €123,819.

InflaRx N.V. (IFRX) - Canvas Business Model: Cost Structure

You're looking at the core expenses that fuel InflaRx N.V.'s engine, which is heavily weighted toward getting its pipeline candidates, especially vilobelimab and INF904, through late-stage development. For a clinical-stage biopharma, the cost structure is almost entirely driven by R&D and the associated overhead to manage those complex trials.

The financial data for the first half of 2025 (H1 2025, six months ended June 30, 2025) shows where the majority of cash burn is occurring. It's a classic profile for a company pushing its lead assets through pivotal studies.

The most dominant cost category is, unsurprisingly, Research and Development (R&D). For H1 2025, InflaRx N.V. reported R&D expenses totaling €14.2 million. This figure reflects the ongoing investment in their clinical programs, though it was noted to have decreased by €3.1 million compared to the same period in 2024.

General and Administrative (G&A) expenses also represent a significant fixed cost base. For the six months ended June 30, 2025, G&A expenses reached €8.3 million. This was an increase of €1.5 million compared to H1 2024.

Here's a quick breakdown of the key components contributing to the operating costs for H1 2025:

Cost Component H1 2025 Amount (€) Comparison Note
Research and Development (R&D) Expenses 14.2 million Decreased by €3.1 million versus H1 2024
General and Administrative (G&A) Expenses 8.3 million Increased by €1.5 million versus H1 2024
Personnel Expenses (Included in G&A/R&D) 4.3 million Reported personnel expenses for the six-month period

Clinical trial and regulatory costs are embedded within the R&D spend. The decrease in R&D was specifically attributed to lower third-party expenses related to clinical material and manufacturing. This suggests that certain large, upfront costs associated with the Phase 3 vilobelimab trial in pyoderma gangrenosum (PG), which was stopped for futility, or earlier manufacturing scale-up activities, were lower in H1 2025 than in H1 2024.

Manufacturing and supply chain costs for vilobelimab production, which relies on partners like WuXi Biologics, are a critical variable cost. While specific external manufacturing fees aren't itemized, the reduction in R&D third-party expenses suggests a favorable shift in these external service provider costs for the period.

Personnel expenses are a major driver of the G&A increase. The reported personnel expenses for H1 2025 were €4.3 million. This increase in headcount or compensation structure is also linked to the G&A rise, alongside higher legal and consulting fees of €2.4 million.

The key cost drivers and their components are:

  • Dominant R&D spend: €14.2 million for H1 2025.
  • G&A expenses: Totaled €8.3 million for H1 2025.
  • Personnel costs: Accounted for €4.3 million of the total expenses.
  • R&D cost reduction driver: Lower third-party expenses for clinical material and related manufacturing.
  • G&A cost driver: Higher legal and consulting expenses of €2.4 million.

Finance: draft 13-week cash view by Friday.

InflaRx N.V. (IFRX) - Canvas Business Model: Revenue Streams

You're looking at the top line for InflaRx N.V. as of late 2025, focusing strictly on where the money is coming from right now. For a clinical-stage company, revenue streams are often a mix of product sales, non-dilutive funding like allowances, and capital raises that keep the lights on while development continues. Here's the quick math on what's flowing in, based on the first half of 2025.

The most direct revenue comes from the commercial product, GOHIBIC (vilobelimab). For the six months ended June 30, 2025, InflaRx N.V. realized €39 thousand in revenues from sales of GOHIBIC, which are attributed to sales in the United States. That's a small figure, honestly, which is typical when a product is newly authorized and the focus remains heavily on pipeline advancement.

Beyond product sales, InflaRx N.V. pulls in income from government incentives. Other income, which is primarily sourced from research allowances, totaled €1.5 million for the six months ended June 30, 2025. This compares to just €53 thousand for the same period in 2024, showing a significant increase in this non-core revenue component.

The company also secures significant, albeit infrequent, cash through equity financing. A major event in early 2025 was the completion of an underwritten public offering in February 2025, which brought in gross proceeds of €28.7 million before accounting for underwriting discounts and expenses. This capital is crucial for funding clinical development, including for vilobelimab and INF904.

Here is a snapshot of these key revenue and cash-inflow components for the first half of 2025:

Revenue/Income Source Amount (H1 2025) Notes
Product Sales (GOHIBIC) €39 thousand Revenues attributed to sales in the United States.
Other Income (Research Allowances) €1.5 million Primarily from research allowances.
Equity Financing (Feb 2025 Offering) €28.7 million (Gross Proceeds) Capital raised to fund pipeline development.

You also have to factor in potential future payments from partnerships. InflaRx N.V. has co-development agreements, like the one involving the partnered C5a antibody BDB-001, which could generate mid-single-digit royalties if successfully commercialized. While these are not current revenue for H1 2025, they represent a key part of the long-term revenue stream model, contingent on clinical success.

To keep things clear, here are the main categories that make up the top-line picture for InflaRx N.V. as of the mid-year point:

  • Product sales of GOHIBIC (vilobelimab), generating €39 thousand in H1 2025.
  • Other income, primarily from research allowances, totaling €1.5 million in H1 2025.
  • Equity financing proceeds, such as the €28.7 million gross proceeds from the February 2025 public offering.
  • Potential future milestone and royalty payments from co-development agreements.

Finance: review the cash runway projection based on the February 2025 financing by next Tuesday.


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