INFLARX N.V.

 

 

FINANCIAL STATEMENTS – MARCH 31, 2025

 

These unaudited condensed financial statements are consolidated financial statements for the group consisting of InflaRx N.V. and its wholly-owned subsidiaries InflaRx GmbH, Jena, Germany, and InflaRx Pharmaceuticals Inc., Ann Arbor, Michigan, United States (together, the “Group”). The financial statements are presented in euros (€).

 

InflaRx N.V. is a company limited by shares, incorporated and domiciled in Amsterdam, The Netherlands.

Its registered office and principal place of business is in Germany, Jena, Winzerlaer Str. 2

 

Index to unaudited condensed consolidated financial statements

for the three months ended March 31, 2025

 

 

 

 

 

 

 

 

 

*unaudited

 

 

 

 

 

 

 

 

 

 

InflaRx N.V. (the “Company” or “InflaRx”) is a Dutch public company with limited liability (naamloze vennootschap) with its corporate seat in Amsterdam, the Netherlands, and is registered in the Commercial Register of the Netherlands Chamber of Commerce Business Register under CCI number 68904312. The Company’s registered office is at Winzerlaer Straße 2 in 07745 Jena, Germany. Since November 10, 2017, InflaRx N.V.’s ordinary shares have been listed on the Nasdaq Global Select Market under the symbol IFRX.

 

InflaRx is a biopharmaceutical company pioneering anti-inflammatory therapeutics targeting the complement system by focusing on applying its proprietary anti-C5a and C5aR technologies to discover, develop and commercialize first-in-class, potent and specific inhibitors of the complement activation factor known as C5a and its receptor C5aR. On April 4, 2023, the U.S. Food and Drug Administration, or “FDA” issued an Emergency Use Authorization, or “EUA” for GOHIBIC (vilobelimab), for the treatment of COVID-19 in critically ill, invasively mechanically ventilated hospitalized adults. In January 2025, the European Commission, or “EC” granted marketing authorization under exceptional circumstances for GOHIBIC (vilobelimab) for the treatment of adult patients with SARS-CoV-2-induced acute respiratory distress syndrome, or “ARDS” who are receiving systemic corticosteroids as part of standard of care and receiving invasive mechanical ventilation with or without extracorporeal membrane oxygenation. These consolidated financial statements of InflaRx comprise the Group.

 

 

These interim condensed consolidated financial statements for the three-month reporting period ended March 31, 2025, and 2024 have been prepared in accordance with IAS 34 Interim Financial Reporting. These condensed consolidated financial statements do not include all the information and disclosures required in the annual financial statements. Accordingly, this report is to be read in conjunction with the financial statements in the Company’s Annual Report for the year ended December 31, 2024 on Form 20–F.

 

The interim condensed consolidated financial statements were authorized for issue by the board of directors of the Company (the “Board of Directors”) on May 6, 2025.

 

The financial statements are presented in euros (€). The euro is the functional currency of InflaRx N.V. and InflaRx GmbH. The functional currency of InflaRx Pharmaceuticals Inc. is the U.S. dollar.

 

All financial information presented in euros have been rounded to the nearest euro. Accordingly, numerical figures shown as totals in some tables may not be an arithmetic aggregation of the figures that precede them or may deviate from other tables.

 

The accounting policies adopted are consistent with those followed in the preparation of the Group’s annual consolidated financial statements for the year ended December 31, 2024, except for the adoption of new standards effective as of January 1, 2025, as set out below. The Group has not adopted any other standard, interpretation or amendment that has been issued but is not yet effective early.

 

The following amendments were adopted effective January 1, 2025, and do not have a material impact on the consolidated financial statements of the Group:

 

 

The following standards issued will be adopted in a future period, and the potential impact, if any, they will have on the Group’s consolidated financial statements is being assessed:

 

 

 

 

 

Pre-funded warrants are largely paid upfront and are classified as a liability in “liabilities to warrant holders” in the statements of financial position due to the settlement provisions failing to meet the 'fixed for fixed' requirement in paragraph 16(b)(ii) of IAS 32. The pre-funded warrants are valued at their fair value with any resulting change in fair value recognized in “Other financial result” within the statements of operations and comprehensive loss. The pre-funded warrants can be exercised for ordinary shares upon a cashless exercise in accordance with the terms of the pre-funded warrant. These warrants are exercisable at any time without limitation. The fair value of pre-funded warrants is determined using a Black-Scholes valuation model and approximates the value of the underlying ordinary shares at the time of their valuation. Please also refer to notes 12 and 15 for additional information.

 

 

For the three months ended March 31, 2025 and 2024, the Company realized revenues from product sales of GOHIBIC (vilobelimab) in the amount of €0 thousand and €36 thousand, respectively.

 

 

 

For the three months ended March 31, 2025 and 2024, the Company’s cost of sales amounted to €9 thousand and €221 thousand, respectively. Cost of sales mainly consist of write-downs of inventories that will expire prior to their expected sales.

 

 

During the three months ended March 31, 2025, the Group incurred €1.5 million (2024: €1.5 million) of sales and marketing expenses in the United States. These expenses are mainly composed of €0.6 million (2024: €0.3 million) in personnel costs and €0.2 million (2024: €0.7 million) in external services for distribution and €0.2 million (2024: €0.7 million) in marketing expenses of GOHIBIC (vilobelimab).

 

 

During the three months ended March 31, 2025, the Group incurred €7.0 million (2024: €7.3 million) of research and development expenses. These expenses are mainly composed of €2.7 million (2024: €2.4 million) in personnel costs and €4.0 million (2024: €4.1 million) in external services for the Group’s research and development projects.

 

 

During the three months ended March 31, 2025, the Group incurred €5.1 million (2024: €3.6 million) of general and administration expenses. These expenses are mainly composed of €2.6 million (2024: €2.0 million) in personnel costs, €1.0 million (2024: €0.6 million) in legal, consulting and audit fees, €1.5 million (2024: €1.0 million) in other general and administrative expenses.

 

 

Other income for the three months ended March 31, 2025 amounted to €541.1 thousand (2024: €36.3 thousand), related to eligible expenses incurred from research allowances during the period. During the first three months ended March 31, 2024, the Group has not recorded other income from research allowances.

 

 

Net financial result increased by €1.9 million to a gain of €4.7 million for the three months ended March 31, 2025 from a gain of €2.8 million for the three months ended March 31, 2024. This increase is mainly attributable to the fair value revaluation of pre-funded warrants issued in February 2025 in the amount of €6.1 million, and is partly offset by a decrease of the foreign exchange result by €3.7 million due to the weakening of the U.S. dollar and by a decrease of the financial result by €0.4 million due to lower interest income on marketable securities, in each case, compared to the three months ended March 31, 2024.

 

 

As of March 31, 2025, inventory is nearly unchanged compared to December 31, 2024

 

 

As of March 31, 2025, prepayments on research and development projects amounted to €4.3 million compared to €4.6 million as of December 31, 2024, and consist of prepayments on CRO and CDMO contracts.

 

Prepaid expenses consist mainly of prepaid D&O insurance expense for the year 2025, which will be recognized into general and administrative expenses pro rata over the year.

 

As of March 31, 2025, other assets from research allowances were €5.6 million compared to €5.1 million as of December 31, 2024, which represent reimbursements the Company qualifies for under the German Research Allowance Act. The increase is due to additional receivables recognized for eligible expenses incurred in the three months ended March 31, 2025.

 

 

As of March 31, 2025, tax receivables amounted to €1.7 million compared to €1.7 million as of December 31, 2024.

 

 

Set out below is an overview of financial assets and liabilities, other than cash and cash equivalents, held by the Group as of March 31, 2025 and December 31, 2024:

 

In February 2025, the Company issued 6,750,000 pre-funded warrants to certain investors in the context of a public offering of securities. As of March 31, 2025, the fair value of the warrants amounted to €6.4 million.

 

As of March 31, 2025, the fair value of current and non-current financial assets (primarily quoted debt securities) amounted to €18.8 million (as of December 31, 2024 €37.6 million) (Level 1). The Group’s debt instruments at amortized cost consist solely of quoted securities that are graded highly by credit rating agencies such as S&P Global and, therefore, are considered low credit risk investments.

 

As of March 31, 2025, current and non-current financial assets decreased by €18.7 million to €18.8 million compared to €37.6 million of December 31, 2024. The decrease is mainly due to the maturity of financial assets, and their subsequent reinvestment into interest bearing bank deposits, which are accounted for as part of cash and cash equivalents.

 

As of March 31, 2025, trade and other payables decreased by €3.0 million to €8.5 million compared to €11.5 million as of December 31, 2024. As of December 31, 2024 the Company temporarily had higher trade payables from CDMO’s, that arose in connection with the manufacturing of commercial products.

 

 

Accrued liabilities from R&D projects include third party services from the Company’s ongoing R&D projects that have not yet been invoiced to the Company as of the reporting date.

 

 

As of March 31, 2025, cash and cash equivalents increased by €28.9 million to €47.3 million compared to €18.4 million as of December 31, 2024. The increase is mainly due to a public offering in February 2025 with net proceeds in the amount of €26.8 million ($28.0 million). Certain financial assets having reached their maturity, and the subsequent reinvestment into interest bearing bank deposits, which are classified as cash and cash equivalents.

 

 

On June 30, 2023, the Company filed a Form F-3, or the 2023-Registration Statement, with the Securities Exchange Commission, or the SEC, with respect to the offer and sale of securities of the Company, which became effective on July 11, 2023. The aggregate initial offering price of the securities that the Company may offer and sell under this prospectus will not exceed $250.0 million. In June 2024, the Company subsequently filed a prospectus supplement with the SEC relating to an at-the-market program providing for the sale of up to $75.0 million of our ordinary shares over time pursuant a sales agreement with Leerink Partners LLC, or the Sales Agreement.

 

In the three months ended March 31, 2025, we issued 145,420 ordinary shares under our ATM program, resulting in $353 thousand in net proceeds. Following this issuance under the ATM program, the remaining value authorized for sale under the ATM program is $73.6 million.

 

In February 2025, the Company completed an underwritten public offering of 8,250,000 ordinary shares at a public offering price of $2.00 per ordinary share and, in lieu of ordinary shares to certain investors, pre-funded warrants to purchase 6,750,000 ordinary shares. The public offering price for each pre-funded warrant was equal to the price per share at which the ordinary shares were sold to the public, minus $0.001, which is the exercise price of each pre-funded warrant. The warrants are only exercisable by cashless exercise; the amount of ordinary shares to be received upon cashless exercise of such warrants is dependent on the Company’s market share price at the time of exercise. The net proceeds from the offering were €26.8 million ($28.0 million). The warrants have an indefinite expiration and are fully or partly exercisable at any time.

 

 

 

InflaRx GmbH granted options under the 2012 Stock Option Plan. Those InflaRx GmbH options were converted into options for ordinary shares of InflaRx N.V. at the time of its IPO in November 2017:

 

Under the terms and conditions of the 2015 Stock Option Plan, InflaRx GmbH granted rights to subscribe for InflaRx GmbH’s ordinary shares to directors, senior management, and key employees. Those InflaRx GmbH options were converted into options for ordinary shares of InflaRx N.V. at the time of its IPO in November 2017:

 

InflaRx also granted share options under the 2017 Long-Term Incentive Plan, or 2017 LTIP, subsequently to its IPO in November 2017. Certain stock options granted between 2017 and 2020 were issued with an eight-year option term and during the three months ended March 31, 2025, were extended to an option term of ten years. The total number of share options granted during the three months ended March 31, 2025 under the 2017 LTIP was as follows:

 

The number of share options granted during the three months ended March 31, 2025 under the 2017 LTIP was as follows:

 

Of the 2,452,000 options granted in the three months ended March 31, 2025 (ended March 31, 2024: 2,275,000), 1,700,000 options (March 31, 2024: 1,615,000) were granted to members of the executive management or Board of Directors.

 

Expected dividends are nil for all share options listed above.

 

 

For the three months ended March 31, 2025, the Company has recognized €2.5 million (2024: €1.8 million) of share-based payment expense in the statements of operations and comprehensive loss including €356 thousand (ended March 31, 2024: nil) for the extension of option for the eight year option terms to ten years.

 

None of the share-based payment awards were dilutive in determining earnings per share due to the Group’s loss position.

 

 

During the three months ended March 31, 2025, no shares (2024: nil) were issued upon the exercise of share options, resulting in no proceeds to the Company (ended March 31, 2024: nil).

 

 

According to the articles of association of the Company, up to 147,200,000 ordinary shares and up to 147,200,000 preferred shares with a nominal value of €0.12 per share are authorized to be issued. All shares are registered shares. No share certificates shall be issued.

 

In order to deter acquisition bids, the Company’s general meeting of shareholders approved the right of an independent foundation under Dutch law, or protective foundation, to exercise a call option pursuant to the call option agreement, upon which preferred shares will be issued by the Company to the protective foundation of up to 100% of the Company’s issued capital held by others than the protective foundation, minus one share. The protective foundation is expected to enter into a finance arrangement with a bank or, subject to applicable restrictions under Dutch law, the protective foundation may request the Company to provide, or cause the Company’s subsidiaries to provide, sufficient funding to the protective foundation to enable it to satisfy its payment obligation under the call option agreement.

 

These preferred shares will have both a liquidation and dividend preference over the Company’s ordinary shares and will accrue cash dividends at a pre-determined rate. The protective foundation would be expected to require the Company to cancel its preferred shares once the perceived threat to the Company and its stakeholders has been removed or sufficiently mitigated or neutralized. The Company believes that the call option does not represent a significant fair value based on a level 3 valuation since the preferred shares are restricted in use and can be cancelled by the Company.

 

During the three months ended March 31, 2025, the Company expensed €15 thousand (2024: €13 thousand) of ongoing costs to reimburse expenses incurred by the protective foundation.

 

F-14

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continue to develop and conduct clinical trials with respect to our lead product candidate, vilobelimab;

•

continue research, preclinical and clinical development efforts, as applicable, for any future product candidates, including INF904 and IFX002;

•

actively seek to identify additional research programs and additional product candidates;

•

seek regulatory and marketing approvals for our product candidates that successfully complete clinical trials, if any;

•

establish sales, marketing, distribution and other commercial infrastructure now and in the future to commercialize various products for which we may obtain marketing authorization or approval, if any;

•

require the scale-up and validation of the manufacturing process and the manufacturing of larger quantities of product candidates for clinical development and, potentially, commercialization;

•

collaborate with strategic partners to optimize the manufacturing process for vilobelimab, IFX002, INF904 and other pipeline products;

•

maintain, expand and protect our intellectual property portfolio;

•

hire and retain additional personnel, such as commercial, marketing, clinical, quality control and scientific personnel; and

•

add operational, financial and management information systems and personnel, including personnel to support our product development as well as commercialization and help us comply with our obligations as a public company.

•

external services for distribution of GOHIBIC to build the necessary commercial and logistical infrastructure, including external sales professionals;

•

marketing activities;

•

employee-related expenses, including salaries, benefits and stock-based compensation expense based upon employees’ role within the organization; and

•

professional services fees in conjunction with making GOHIBIC available to hospitals and patients in the U.S.

•

expenses incurred under agreements with CROs, contract development and manufacturing organizations, or CDMOs, consultants and independent contractors that conduct research and development, preclinical and clinical activities on our behalf;

•

employee-related expenses, including salaries, benefits and stock-based compensation expense based upon employees’ role within the organization; and

•

professional fees for lawyers related to the protection and maintenance of our intellectual property.

•

Vilobelimab. We expect our expenses associated with vilobelimab will continue to increase in 2025 compared to 2024, as we progress in the Phase 3 clinical study in PG. In addition, we incur and expect to continue to incur expenses in conjunction with the preparation and filing of full market authorizations for vilobelimab in the United States, Europe and elsewhere. We may also consider development of vilobelimab in additional indications. In addition, we are also incurring expenses related to the manufacturing of clinical trial material and the completion of activities towards the final establishment of commercial scale production.

•

INF904. We are developing INF904, a product candidate that targets C5aR. We expect to incur additional costs by advancing the clinical and non-clinical development of INF904. Specifically, we expect to incur expenses by developing a new formulation, continuing our Phase 2a trial and potentially initiating larger Phase 2 clinical trials. We plan to study INF904 in complement-mediated, chronic autoimmune and inflammatory conditions where an oral low molecular weight compound might have advantages or is needed for patients and where oral delivery is the medically preferred route of administration. Initially targeted indications include CSU and HS.

•

IFX002. We are developing IFX002 for the treatment of chronic inflammatory indications. IFX002 is a highly potent anti-complement C5a antibody with a higher humanization grade and altered PK properties compared to vilobelimab and is currently in pre-clinical development. Expenses for this program mainly consist of salaries, costs for preclinical testing conducted by CROs and costs to produce preclinical material.

•

Other development programs. Our other research and development expenses relate to our preclinical studies of other product candidates and discovery activities, expenses for which mainly consist of salaries, costs for production of preclinical compounds and costs paid to CROs.

•

employee-related expenses, including salaries, benefits and stock-based compensation expense based upon employees’ role within the organization;

•

insurance expenses including directors´ and officers´ liability insurance premiums;

•

professional fees for auditors and consulting expenses not related to research and development activities;

•

professional fees for lawyers not related to the filing, prosecution, protection and maintenance of our intellectual property; and

•

cost of facilities, travel, communication and office expenses.

		three months ended March 31,
		2025				2024				Change
		(in €)
Revenues			—				36,037				(36,037	)
Cost of sales			(9,291	)			(220,521	)			211,230
Gross profit			(9,291	)			(184,484	)			175,193
Operating expenses
Sales and marketing expenses			(1,457,978	)			(1,459,539	)			1,561
Research and development expenses			(7,016,336	)			(7,301,810	)			285,473
General and administrative expenses			(5,062,605	)			(3,579,150	)			(1,483,454	)
Total operating expenses			(13,536,919	)			(12,340,499	)			(1,196,420	)
Other income			541,098				36,323				504,774
Other expenses			(26	)			(30	)			4
Operating result			(13,005,139	)			(12,488,690	)			(516,449	)
Finance income			493,764				908,426				(414,662	)
Finance expenses			(4,086	)			(4,632	)			546
Foreign exchange result			(1,908,829	)			1,824,376				(3,733,205	)
Other financial result			6,110,264				103,285				6,006,978
Income taxes			—				—				—
Income (loss) for the period			(8,314,027	)			(9,657,236	)			1,343,209
Exchange differences on translation of foreign currency			(150,667	)			(25,538	)			(125,129	)
Total comprehensive income (loss)			(8,464,694	)			(9,682,774	)			1,218,079

		three months ended March 31,
		2025				2024				Change
		(in €)
Revenues			—				36,037				(36,037	)
Total			—				36,037				(36,037	)

		three months ended March 31,
		2025				2024				Change
		(in €)
Cost of sales			9,291				220,521				(211,230	)
Total			9,291				220,521				(211,230	)

		three months ended March 31,
		2025				2024				Change
		(in €)
Third-party expenses			207,811				709,763				(501,952	)
Marketing expenses			205,078				84,803				120,274
Personnel expenses			644,216				323,573				320,643
Legal and consulting fees			261,332				315,243				(53,911	)
Other expenses			139,541				26,156				113,384
Total sales and marketing expenses			1,457,978				1,459,539				(1,561	)

		three months ended March 31,
		2025				2024				Change
		(in €)
Third-party expenses			3,969,044				4,116,271				(147,226	)
Personnel expenses			2,678,658				2,446,620				232,038
Legal and consulting fees			223,113				387,052				(163,939	)
Other expenses			145,520				351,867				(206,347	)
Total research and development expenses			7,016,336				7,301,810				(285,474	)

		three months ended March 31,
		2025				2024				Change
		(in €)
Personnel expenses			2,628,711				2,020,375				608,336
Legal, consulting and audit fees			969,883				570,126				399,757
Other expenses			1,464,011				988,650				475,361
Total general and administrative expenses			5,062,605				3,579,150				1,483,454

		three months ended March 31,
		2025				2024				Change
		(in €)
Other income from government grants and research allowances			532,860				—				532,860
Further other income			8,238				36,323				(28,086	)
Total other income			541,098				36,323				504,774

		three months ended March 31,
		2025				2024				Change
		(in €)
Interest income			493,764				908,426				(414,662	)
Interest expenses			(443	)			(439	)			(4	)
Interest on lease liabilities			(3,643	)			(4,193	)			550
Financial result			489,678				903,794				(414,117	)
Foreign exchange income			1,229,009				2,049,582				(820,574	)
Foreign exchange expense			(3,137,838	)			(225,207	)			(2,912,631	)
Foreign exchange result			(1,908,829	)			1,824,375				(3,733,205	)
Result of expected credit loss adjustment on marketable securities			—				103,285				(103,285	)
Result from the revaluation of pre-funded warrants at fair value			6,110,264				—				6,110,264
Other financial result			6,110,264				103,285				6,006,979
Net financial result			4,691,112				2,831,454				1,859,658

		three months ended March 31,
		2025				2024
		(in €)
Net cash used in operating activities			(14,015,672	)			(14,868,364	)
Net cash from/ (used in) investing activities			17,655,632				26,944,804
Net cash from/ (used in) financing activities			27,009,268				(85,706	)
Cash and cash equivalents at the beginning of the period			18,375,979				12,767,943
Exchange gains/ (losses) on cash and cash equivalents			(1,738,808	)			344,381
Cash and cash equivalents at the end of the period			47,286,630				25,103,058

•

our ability to successfully secure distribution channels and commercialize GOHIBIC (vilobelimab) as a treatment for COVID-19 patients and the receptiveness of 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 EUA, 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 other debilitating or life-threatening inflammatory indications, including ARDS, PG and any other product candidates, including INF904, and whether such clinical results will reflect results seen in previously conducted pre-clinical studies and clinical trials;

•

the timing, progress and results of preclinical studies and clinical trials of vilobelimab, INF904 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 PG, 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 BLA submission for GOHIBIC (vilobelimab);

•

the timing and outcome of any discussions or submission of filings for regulatory approval or authorization of vilobelimab, INF904 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-C5aR 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, INF904 and any other product candidates, and the scope of such protection;

•

whether the FDA, EMA 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, INF904 and any other product candidates and whether such clinical results will reflect results seen in previously conducted preclinical 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, INF904 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 U.S. 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, INF904 or any other of our product candidates is being developed or our industry; and

•

other risk factors discussed under the “ITEM 3. Key information––Risk factors” section of our Annual Report on Form 20-F

Exhibit 99.3

 

InflaRx Reports First Quarter 2025 Financial Results and

Provides Business Update

 

 

Jena, Germany, May 7, 2025 – InflaRx N.V. (Nasdaq: IFRX), a biopharmaceutical company pioneering anti-inflammatory therapeutics by targeting the complement system, today announced its financial results for the three months ended March 31, 2025, and provided a business update.

 

Prof. Niels C. Riedemann, Chief Executive Officer and Founder of InflaRx, commented: “We are excited about the upcoming near-term milestones with our key programs, including the interim analysis for the Phase 3 trial with vilobelimab in pyoderma gangrenosum and topline Phase 2a data with INF904. These catalysts could significantly de-risk the Company’s pipeline and unlock significant value, propelling InflaRx closer to our goal of bringing meaningful new therapeutic options to patients suffering from chronic inflammatory conditions.”

 

Select recent highlights and business update

 

Vilobelimab in PG – Announcement on pivotal Phase 3 interim analysis expected at end of May to early June 2025

 

The interim analysis for the vilobelimab Phase 3 trial in pyoderma gangrenosum (PG), to determine trial size adaptation or futility, remains on schedule with the IDMC (independent data monitoring committee) recommendation expected to be announced by the Company at the end of May to early June, subject to minor variability in the timing of final IDMC-related workflows. This interim analysis (unblinded only for the IDMC) is planned for when 30 patients randomized 1:1 to the two arms have completed treatment. The analysis has a set of predefined rules and will consider the then-observed difference in complete target ulcer closure between the two arms and will determine whether the trial sample size should be adapted or whether the trial should be stopped due to futility. The study dosed its first patient in November 2023 and continues to enroll new patients. Total enrollment is projected to last at least two years, and the overall timing will depend on the total trial size after sample size adaptation.

 

Vilobelimab has been granted orphan drug designation for the treatment of PG by both the U.S. Food and Drug Administration (FDA) and the European Medicines Agency (EMA), as well as fast track designation by the FDA.

 

INF904 in CSU and HS – Topline Phase 2a data expected in summer 2025

 

InflaRx is conducting a Phase 2a basket study with INF904 in CSU and HS, with topline data expected in the summer of 2025. This is a multi-center, open-label study evaluating multiple INF904 dosing regimens over 4 weeks of treatment in a total of 75 patients (45 with CSU and 30 with HS). The goal of the trial is to generate safety and pharmacokinetic (PK) data and to provide signs of clinical benefit, with an objective of informing the planning and design of a larger, longer-term Phase 2b study by year-end 2025.

 

The Company also successfully completed the required sub-chronic and chronic toxicology studies for INF904. No safety signals of concern were identified, supporting the potential for long-term dosing in future clinical efforts. Additional required non-clinical studies remain ongoing as planned.

 

InflaRx believes CSU and HS each have potential addressable markets of $1 billion or more for INF904. The Company also believes INF904 could address meaningful opportunities in additional immuno-dermatology and immuno-inflammatory indications, including in nephrology, neurology and hematology. While InflaRx intends to focus its resources on its immediate goals addressing CSU and HS, the Company continues to assess and monitor the value of pursuing additional areas and applications via potential future collaborations with partners.

 

GOHIBIC (vilobelimab) granted EU marketing authorization

 

In January 2025, the European Commission (EC) granted marketing authorization under exceptional circumstances for GOHIBIC (vilobelimab) for the treatment of adult patients with SARS-CoV-2-induced acute respiratory distress syndrome (ARDS) who are receiving systemic corticosteroids as part of standard of care and receiving invasive mechanical ventilation (IMV) with or without extracorporeal membrane oxygenation (ECMO). GOHIBIC (vilobelimab) is the first and only treatment approved in the European Union (EU) for the treatment of SARS-CoV-2-induced ARDS. InflaRx is considering commercial partnering and distribution options in the EU and does not expect this approach will have a materially negative impact on its cash burn rate.

 

Dr. Thomas Taapken, Chief Financial Officer of InflaRx, said: “InflaRx’s balance sheet is strong as the Company enters a period of multiple expected catalysts and potential value inflection points over the remainder of 2025 and beyond. With our solid financial position, we are able to invest in our key development programs while maintaining a cash runway into 2027.”

 

Financial highlights – Q1 2025

 

Financing activities

 

In February 2025, the Company completed an underwritten public offering of ordinary shares and pre-funded warrants, raising gross proceeds of €28.7 million ($30.0 million), before deducting the underwriting discount and offering expenses.

 

Revenue

 

For the three months ended March 31, 2025, we realized no revenues from the product sales of GOHIBIC (vilobelimab). Compared to the three months ended March 31, 2024, this is a decrease of €36 thousand. Sales to distributors do not constitute revenue for the Company. All revenues are attributed to sales made in the United States.

 

 

Cost of sales during the three months ended March 31, 2025 amounted to €9.3 thousand due to inventory write-offs in connection with the replacement of product with an expiring shelf-life. This represents a decrease of €0.2 million compared to the three months ended March 31, 2024.

 

 

Sales and marketing expenses incurred for the three months ended March 31, 2025 amounted to €1.5 million and were nearly unchanged compared to the three months ended March 31, 2024.

 

 

Research and development expenses for the three months ended March 31, 2025 decreased by €0.3 million to €7.0 million, compared to the three months ended March 31, 2024. This decrease is primarily due to lower third-party expenses incurred in connection with the Company’s efforts to develop INF904.

 

 

General and administrative expenses for the three months ended March 31, 2025 increased by €1.5 million compared to the three months ended March 31, 2024, mainly due to higher legal, consulting and audit expenses of €0.4 million and higher other expenses in the amount of €0.5 million, mainly in conjunction with the issuance of pre-funded warrants in our recently conducted public offering and higher personnel expenses due to share based payments.

 

 

Other income for the three months ended March 31, 2025 amounted to €0.5 million, compared to €36 thousand for the three months ended March 31, 2024. Other income was primarily due to income from research allowances.

 

 

Net financial result increased by €1.9 million to a gain of €4.7 million for the three months ended March 31, 2025 from a gain of €2.8 million for the three months ended March 31, 2024. This increase is mainly attributable to the fair value revaluation of pre-funded warrants issued in February 2025 in the amount of €6.1 million, as well as to a decrease of the foreign exchange result by €3.7 million due to the weakening of the U.S. dollar and a decrease of interest income on marketable securities (due to lower investments in 2025) by €0.4 million, in each case, compared to the three months ended March 31, 2024.

 

Net loss

 

We incurred a net loss of €8.3 million, or €0.13 per ordinary share, in the first quarter of 2025, compared to €9.7 million, or €0.17 per ordinary share, in 2024.

 

 

As of March 31, 2025, our total funds available amounted to approximately €65.7 million, comprised of €47.3 million of cash and cash equivalents and €18.4 million of marketable securities.

 

Net cash used in operating activities

 

 

Net cash from financing activities

 

Net cash from financing activities increased by €27.1 million in the three months ended March 31, 2025, to €27.0 million, compared to the three months ended March 31, 2024, due to a public offering of ordinary shares and pre-funded warrants in February 2025.

 

Additional financial information

 

Additional information regarding these results and other relevant information is included in the notes to the financial statements in “Item 18. Financial Statements”, which are included in InflaRx’s most recent annual report on Form 20-F as filed on March 20, 2025 with the U.S. Securities and Exchange Commission.

 

Unaudited condensed consolidated statements of operations and comprehensive loss for the three months ended March 31, 2025 and 2024

 

Unaudited condensed consolidated statements of financial position as of March 31, 2025 and December 31, 2024

 

Unaudited condensed consolidated statements of changes in shareholders’ equity