Tocilizumab

- Company announces positive initial Phase 1a dose escalation data for monotherapy CX-904 (EGFRxCD3 T-cell engager) in solid tumors - - First dose cohort cleared in Phase 1 clinical study of CX-2051, an EpCAM Targeting PROBODY® ADC, in solid tumors. Initial data anticipated in the first half of 2025 - - Phase 1 study initiation activities continue for CX-801, an interferon alpha-2b PROBODY® cytokine, including the execution of a clinical collaboration agreement with Merck to supply KEYTRUDA® (pembrolizumab) for evaluation in combination with CX-801. Initial data anticipated in 2025 - - Achieved $10 million of milestones under T-cell engaging bispecific collaboration with Astellas for preclinical progress on the first two programs in the collaboration - - Dr. Zhen Su appointed to Board of Directors - - Management to hold conference call today at 5 p.m. EDT / 2 p.m. PDT - SOUTH SAN FRANCISCO, Calif., May 08, 2024 (GLOBE NEWSWIRE) -- CytomX Therapeutics, Inc. (Nasdaq: CTMX), a leader in the field of masked, conditionally activated biologics, today reported first quarter 2024 financial results and provided a business update. “CytomX’s multi-modality PROBODY® therapeutic pipeline encompasses some of the most exciting areas of current oncology R&D, including T-cell engagers, ADCs, and cytokines. CytomX’s leadership and continuous innovation in the field of masked, conditionally activated biologics ideally positions us to develop novel, potent therapies for cancer patients in key areas of unmet need,” said Sean McCarthy, D.Phil., chief executive officer and chairman of CytomX. McCarthy added, “CytomX entered 2024 executing to our plan and with substantial momentum, looking towards key data readouts from our multi-modality PROBODY® therapeutic pipeline over the next 12 to 24 months. Our exciting announcement today of positive initial Phase 1a clinical data for CX-904 marks the beginning of this data-rich period and we look forward to making continued progress with our broad program of masked, PROBODY® T-cell engagers and to also demonstrating clinical proof of concept for CX-2051 and CX-801, for which we anticipate initial Phase 1 data in 2025.” First Quarter Business Highlights and Recent Developments Pipeline CX-904, PROBODY® T-cell-engager (TCE) targeted to EGFRxCD3, demonstrates a favorable safety profile and encouraging anti-cancer activity in Phase 1 dose escalation. Dose escalation continues. CX-904 is a conditionally activated PROBODY TCE designed to target the epidermal growth factor receptor (EGFR) on cancer cells and the CD3 receptor on T cells within the tumor microenvironment. CX-904 is being evaluated in an ongoing Phase 1 study. Today, the Company announced positive initial Phase 1 dose escalation data in heavily pre-treated patients with advanced metastatic solid tumor types that are generally known to express EGFR. 19 patients were initially enrolled into non-step dosing cohorts with target doses ranging from 0.007 mg to 6 mg. 16 patients were subsequently enrolled into step-dosing cohorts with target doses ranging from 5 mg to 10 mg and with tocilizumab prophylaxis. Dose escalation continues and enrollment into a cohort with a target dose of 15 mg is ongoing. As of the April 16, 2024 data cutoff, CX-904 demonstrated a favorable safety profile including no observed cases of CRS of any grade in step-dosing cohorts and only Grade 1 CRS observed in patients treated at the highest non-step dose. The most common treatment-related adverse events (TRAEs) were arthralgia, arthritis, rash, pruritis, and vomiting, the majority of which were low grade.Eight patients had measurable tumor reduction, including 2 of 6 (33%) efficacy-evaluable pancreatic cancer patients with confirmed partial responses per RECIST 1.1.Preliminary pharmacokinetic and pharmacodynamic data were consistent with the PROBODY TCE mechanism of action, including maintained masking in circulation, and CD8+ T-cell margination and tumor infiltration.CX-904 Phase 1a dose escalation and optimization continue, with future enrollment focused on determining a recommended Phase 2 dose.The Company expects to provide an additional Phase 1a dose escalation update by the end of 2024. These additional data will help inform next steps along with partner Amgen, towards initiation of Phase 1b expansion cohorts in specific EGFR positive tumor types. CX-2051, an EpCAM-directed PROBODY® antibody drug conjugate, first patient dosed in Phase 1 in April 2024, initial data expected in 2025. EpCAM is a promising oncology target with significant potential that is highly expressed across many indications including colorectal, gastric, endometrial, and ovarian cancers. EpCAM has been clinically validated by locally administered, previously approved cancer therapies. To date, systemically administered anti-EpCAM therapeutics have been unsuccessful due to toxicities in certain epithelial tissues. CX-2051 utilizes a cytotoxic payload that is a derivative of camptothecin, a topoisomerase-1 inhibitor, a class of drug that has shown potent clinical anti-cancer activity in the ADC context for multiple targets and cancer types. CX-2051 has demonstrated a wide predicted therapeutic index in multiple preclinical models, constituting an opportunity for broad clinical use in large patient populations. In April 2024, the first patient was dosed as part of the Phase 1 dose escalation of CX-2051 in patients with solid tumors generally known to express EpCAM, including CRC. The first dose cohort in the CX-2051 Phase 1 study has been cleared and dose escalation continues.The Phase 1 dose escalation study is following a Bayesian Optimal Interval (BOIN) design and is intended to demonstrate initial clinical proof of concept to inform a potential decision to move into dose expansion cohorts in 2025.Initial data for CX-2051 is expected in the first half of 2025. CX-801, a dually-masked PROBODY® interferon-alpha 2b, advancing to Phase 1 in Q2 2024. Executed Clinical Collaboration Agreement with Merck (known as MSD outside of the US and Canada) to evaluate CX-801 in combination with Merck’s anti-PD-1 therapy KEYTRUDA® (pembrolizumab). Interferon-alpha 2b is an immunotherapeutic cytokine that has demonstrated clinical activity and gained regulatory approval previously in multiple cancer types, including locally advanced or metastatic melanoma, renal cancer and bladder cancer. IFNα2b provides a potentially superior approach to activating anti-tumor immune responses compared to other cytokines but its clinical benefit has been limited to date by severe dose-limiting toxicities. CX-801 is an optimized, dually masked, conditionally activated IFNα2b, designed to have an expanded therapeutic index that has the potential to become a cornerstone of combination therapy for a wide range of tumor types. Announced a clinical collaboration agreement with Merck to supply KEYTRUDA for a Phase 1 study of CX-801 in combination with KEYTRUDA.CX-801 is anticipated to initiate Phase 1 dose escalation in patients with solid tumors including melanoma, renal, and head and neck squamous cell carcinoma in Q2 2024. The Phase 1 dose escalation will utilize a BOIN design to evaluate safety and signs of clinical activity for CX-801 monotherapy and for CX-801 in combination with KEYTRUDA.Initial Phase 1 data for CX-801 is expected in 2025. KEYTRUDA® is a registered trademark of Merck Sharp & Dohme LLC, a subsidiary of Merck & Co., Inc., Rahway, NJ, USA. CytomX continues to make progress in its R&D partnerships. CytomX has multiple active research and development partnerships and more than 10 ongoing research programs with major biotechnology and pharmaceutical companies (Amgen, Astellas, Bristol Myers Squibb, Moderna and Regeneron). The majority of these programs are focused on masked, conditionally activated PROBODY® T-cell engagers. In Q1 2024, CytomX achieved $10.0 million in milestones under its multi-target T-cell Engager collaboration with Astellas related to two separate PROBODY® TCE programs: A $5.0 million milestone for the initiation of GLP toxicology studies for the first clinical candidate program in the collaboration.A $5.0 million milestone for the nomination of the second clinical candidate in the collaboration. 2024 Priorities and Key Milestones: CX-904 (EGFRxCD3): CX-904 Phase 1a dose escalation and optimization continue, with future enrollment focused on determining a recommended Phase 2 dose or doses.An additional Phase 1a dose escalation update is expected by the end of 2024.A potential decision, to be taken with Amgen, to initiate Phase 1b expansion cohorts in specific EGFR positive tumor types is expected by the end of 2024. CX-2051 (EpCAM): Continued Phase 1 dose escalation in solid tumors with known EpCAM expression.Initial Phase 1a data is expected in the first half 2025. CX-801 (IFNα2b): Initiation of Phase 1 dose escalation in solid tumors including melanoma, renal, and head and neck squamous cell carcinoma is expected by Q2 2024.Initial Phase 1a data is expected in 2025. Collaborations: Continuation of T-cell engager focused drug discovery and development activities with Bristol Myers Squibb, Amgen, Astellas, and Regeneron.Progress with Moderna on conditionally activated mRNA-based programs.Potential additional pre-clinical and clinical milestones in 2024 and beyond. Q1 2024 Financial Results Cash, cash equivalents and investments totaled $150.3 million as of March 31, 2024, compared to $174.5 million as of December 31, 2023. The cash balance as of March 31, 2024, does not include the $10.0 million of Astellas milestone achievements earned in the first quarter of 2024. Total revenue was $41.5 million for the three months ended March 31, 2024 compared to $23.5 million for the corresponding period in 2023. The increase in revenue was driven primarily by a higher percentage of work completion of existing targets under the BMS, Moderna and Regeneron agreements as well as the $10.0 million of milestones earned under the collaboration with Astellas. Research and development expenses increased by $0.9 million for the three months ended March 31, 2024 to $22.1 million, compared to $21.2 million for the corresponding period of 2023. This was primarily due to increased laboratory contract services and manufacturing activities related to CX-904, CX-2051 and other wholly owned and partnered programs, as well as consulting, personnel and license related expenses, offset by decreased manufacturing activities for CX-801 program and winding down of clinical study activities related to the CX-2009 and CX-2029 programs. General and administrative expenses decreased by $0.2 million for the three months ended March 31, 2024 to $7.8 million compared to $8.0 million for the corresponding period of 2023, primarily due to lower building rent as a result of partial sublease of the Company’s headquarters. Conference Call & WebcastCytomX management will host a conference call and simultaneous webcast today at 5 p.m. EDT (2 p.m. PDT) to discuss the financial results and provide a business update. Participants may access the live webcast of the conference call from the Events and Presentations page of CytomX’s website at https://ir.cytomx.com/events-and-presentations. Participants may register for the conference call here and are advised to do so at least 10 minutes prior to joining the call. An archived replay of the webcast will be available on the company’s website. About CytomX TherapeuticsCytomX is a clinical-stage, oncology-focused biopharmaceutical company focused on developing novel conditionally activated, masked biologics designed to be localized to the tumor microenvironment. By pioneering a novel pipeline of localized biologics, powered by its PROBODY® therapeutic platform, CytomX’s vision is to create safer, more effective therapies for the treatment of cancer. CytomX’s robust and differentiated pipeline comprises therapeutic candidates across multiple treatment modalities including antibody-drug conjugates (“ADCs”), T-cell engagers, and immune modulators such as cytokines. CytomX’s clinical-stage pipeline includes CX-904, CX-2051 and CX-801. CX-904 is a masked, conditionally activated T-cell-engaging bispecific antibody targeting the epidermal growth factor receptor (EGFR) on tumor cells and the CD3 receptor on T cells. CX-904 is partnered with Amgen in a global co-development alliance. CX-2051 is a masked, conditionally activated ADC directed toward epithelial cell adhesion molecule, EpCAM, with potential applicability across multiple EpCAM-expressing epithelial cancers. CX-2051 was discovered in collaboration with Immunogen, now part of AbbVie. CX-801 is a masked interferon alpha-2b PROBODY® cytokine with broad potential applicability in traditionally immuno-oncology sensitive as well as insensitive (cold) tumors. CytomX has established strategic collaborations with multiple leaders in oncology, including Amgen, Astellas, Bristol Myers Squibb, Regeneron and Moderna. For more information about CytomX and how it is working to make conditionally activated treatments the new standard-of-care in the fight against cancer, visit www.cytomx.com and follow us on LinkedIn and X (formerly Twitter). CytomX Therapeutics Forward-Looking StatementsThis press release includes forward-looking statements. Such forward-looking statements involve known and unknown risks, uncertainties and other important factors that are difficult to predict, may be beyond our control, and may cause the actual results, performance, or achievements to be materially different from any future results, performance or achievements expressed or implied in such statements, including those related to the future potential of partnerships or collaboration agreements. Accordingly, you should not rely on any of these forward-looking statements, including those relating to the potential benefits, safety and efficacy or progress of CytomX’s or any of its collaborative partners’ product candidates, including CX-904, CX-2051, and CX-801, the potential benefits or applications of CytomX’s PROBODY® therapeutic platform, CytomX’s or its collaborative partners’ ability to develop and advance product candidates into and successfully complete clinical trials, including the ongoing and planned clinical trials of CX-904, and the timing of the commencement of clinical trials or initial and ongoing data availability for CX-801 and CX-2051, and other development milestones. Risks and uncertainties that contribute to the uncertain nature of the forward-looking statements include: the unproven nature of CytomX’s novel PROBODY® therapeutic technology; CytomX’s clinical trial product candidates are in the initial stages of clinical development and its other product candidates are currently in preclinical development, and the process by which preclinical and clinical development could potentially lead to an approved product is long and subject to significant risks and uncertainties, including the possibility that the results of preclinical research and early clinical trials, including initial CX-904 results, may not be predictive of future results; the possibility that CytomX’s clinical trials will not be successful; the possibility that current preclinical research may not result in additional product candidates; CytomX’s dependence on the success of CX-904, CX-801, and CX-2051; CytomX’s reliance on third parties for the manufacture of the Company’s product candidates; possible regulatory developments in the United States and foreign countries; and the risk that we may incur higher costs than expected for research and development or unexpected costs and expenses. Additional applicable risks and uncertainties include those relating to our preclinical research and development, clinical development, and other risks identified under the heading "Risk Factors" included in CytomX’s Quarterly Report on Form 10-Q filed with the SEC on May 8, 2024. The forward-looking statements contained in this press release are based on information currently available to CytomX and speak only as of the date on which they are made. CytomX does not undertake and specifically disclaims any obligation to update any forward-looking statements, whether as a result of any new information, future events, changed circumstances or otherwise. PROBODY is a U.S. registered trademark of CytomX Therapeutics, Inc. Company Contact:Chris OgdenSVP, Finance and Accountingcogden@cytomx.com Investor Contact:Stern Investor RelationsStephanie Ascherstephanie.ascher@sternir.com Media Contact:Redhouse CommunicationsTeri Dahlmanteri@redhousecomms.com CYTOMX THERAPEUTICS, INC. CONDENSED STATEMENTS OF OPERATIONS AND COMPREHENSIVE LOSS (in thousands, except share and per share data) (Unaudited) Three Months Ended March 31, 2024 2023 Revenues$41,463 $23,499 Operating expenses: Research and development 22,052 21,175 General and administrative 7,754 7,977 Total operating expenses 29,806 29,152 Income (Loss) from operations 11,657 (5,653)Interest income 2,194 2,327 Other (expense) income, net (11) 15 Income (Loss) before income taxes 13,840 (3,311)Provision for income taxes 49 — Net Income (loss) 13,791 (3,311)Other comprehensive income (loss): Unrealized (loss) gain on investments, net of tax (105) 16 Total comprehensive income (loss)$13,686 $(3,295) Net income (loss) per share: Basic$0.17 $(0.05)Diluted$0.17 $(0.05)Shares used to compute net income (loss) per share Basic 82,029,466 66,248,992 Diluted 82,630,020 66,248,992 CYTOMX THERAPEUTICS, INC.CONDENSED BALANCE SHEETS(in thousands) March 31, December 31, 2024 2023 (unaudited) (1) Assets Current assets: Cash and cash equivalents$36,185 $17,171 Short-term investments 114,099 157,338 Accounts receivable 13,177 3,432 Prepaid expenses and other current assets 3,786 4,995 Total current assets 167,247 182,936 Property and equipment, net 3,567 3,958 Intangible assets, net 693 729 Goodwill 949 949 Restricted cash 917 917 Operating lease right-of-use asset 11,234 12,220 Other assets 80 83 Total assets$184,687 $201,792 Liabilities and Stockholders' Deficit Current liabilities: Accounts payable$1,964 $1,458 Accrued liabilities 14,220 17,599 Operating lease liabilities - short term 4,724 4,589 Deferred revenue, current portion 123,628 132,267 Total current liabilities 144,536 155,913 Deferred revenue, net of current portion 59,743 80,048 Operating lease liabilities - long term 8,148 9,385 Other long term liabilities 3,940 3,893 Total liabilities 216,367 249,239 Commitments and contingencies Stockholders' deficit: Convertible preferred stock — — Common stock 1 1 Additional paid-in capital 677,986 675,905 Accumulated other comprehensive (loss) income (10) 95 Accumulated deficit (709,657) (723,448)Total stockholders' deficit (31,680) (47,447)Total liabilities and stockholders' deficit$184,687 $201,792 _____________(1) The condensed balance sheet as of December 31, 2023 was derived from the audited financial statements included in the Company's Annual Report on Form 10-K for the year ended December 31, 2023.

Virtual R&D event to be held on June 5, 2024 from 12:00 to 2:00 PM EDT – highlighting company plans for INF904 and the opportunity, the role of C5aR in chronic spontaneous urticaria (CSU) and hidradenitis suppurativa (HS) and C5a/C5aR signaling in human inflammatory diseases INF904 multiple ascending dose (MAD) pharmacokinetic (PK) and pharmacodynamic (PD) data supporting best-in-class potential announced, and plans to initiate Phase IIa in CSU and HS by the end of 2024, with data availability anticipated in 2025Phase III vilobelimab pyoderma gangrenosum (PG) trial expected to have an interim analysis in 2025Cash, cash equivalents and marketable securities of €85.8 million, expected to fund operations at least into 2026 JENA, Germany, May 08, 2024 (GLOBE NEWSWIRE) -- InflaRx N.V. (Nasdaq: IFRX), a biopharmaceutical company pioneering anti-inflammatory therapeutics targeting the complement system, today announced financial results for the three months ended March 31, 2024, and provided an operating update. Prof. Niels C. Riedemann, Chief Executive Officer and founder of InflaRx, commented: “InflaRx made tremendous progress during the early months of 2024, and is well positioned to advance vilobelimab and INF904 toward meaningful clinical milestones. Our pivotal trial with vilobelimab in PG continues to enroll patients, with an interim analysis expected next year. Patients suffering from PG have no approved treatment alternatives and often experience tremendous suffering. Thus, PG remains an area of high unmet medical need and represents a significant market opportunity for us. Phase I data for INF904 indicate best-in-class potential, and the possibility to address multiple sizable unmet needs, spurring our plans to initiate Phase IIa in CSU and HS by the end of this year. With our clear strategic focus on immuno-dermatology, and the additional potential of our drug candidates in the broader immunology inflammation field, we are excited about the path ahead of us." Virtual R&D event on June 5, 2024InflaRx will host a virtual research and development event on June 5, 2024. Guided by internationally renowned thought leaders, this event will focus on the planned development of InflaRx’s new orally administered, low molecular weight C5aR inhibitor, INF904, and the role of C5aR in CSU and HS. Discussions will address underlying development rationales and expected Phase IIa trial design, and provide insights into the commercial opportunity. In addition, the event will cover INF904's broader therapeutic potential in the immuno-inflammation field and recent advances in our understanding of the role of C5a/C5aR signaling as it relates to human inflammatory diseases. Featured key opinion leaders will include Prof. Dr. Marcus Maurer (Professor of Dermatology and Allergology, Institute of Allergology, Charité – Universitätsmedizin Berlin, Germany), Christopher Sayed, MD (Prof. of Dermatology, University of North Carolina, Medical School; and Secretary of the HS Foundation) and Prof. Dr. Jörg Köhl (Director of the Institute for Systemic Inflammation Research, University of Lübeck, Lübeck, Germany). The meeting will take place on June 5, from 12:00 PM EDT / 6:00 PM CEST to 2:00 PM EDT / 8:00 PM CEST. To participate in the virtual R&D event, participants may pre-register here to receive a dedicated link and dial-in details to access the meeting. Capital One Securities Dermatology Panel on May 14, 2024InflaRx will also participate in the Capital One Securities 1st Annual Biotech/Biopharma Disrupters Event, as a panelist on a panel, titled “New Potential Dermatology Treatments for Psoriasis, Urticaria, and Alopecia” on May 14, 2024, at 2:30 PM EDT / 8:30 PM CEST. Recent Highlights and Business Update INF904 – Initial focus on CSU and HS, broader opportunities in I&I possible via partneringIn March 2024, InflaRx announced it had chosen two initial immuno-dermatology indications it intends to pursue with INF904 and that it plans to initiate a Phase IIa “basket study”. This open-label, 4-week, multi-dose trial enrolling CSU and HS patients is expected to begin by the end of 2024 and to assess safety, as well as PK and PD parameters. InflaRx anticipates releasing data from this Phase IIa study in 2025. Similarly, the company expects to initiate a Phase IIb study in 2025 as well. InflaRx is currently conducting additional pre-clinical studies, including chronic toxicology studies, to enable longer-term dosing of INF904. CSU and HS are two chronic inflammatory skin conditions in which C5a has been suggested to play a significant role and where a high unmet need exists. In addition, as an oral drug with a mechanism of action currently not addressed by other drugs in development for these indications, the company sees a unique opportunity for INF904 to improve the standard of care. INF904 - Positive topline results from Phase I trial support best-in-class potentialIn January 2024, InflaRx reported results from the MAD part of a randomized, double-blind, placebo-controlled Phase I trial in healthy volunteers to assess the safety, tolerability and PK / PD properties of its orally administered, low molecular weight C5aR inhibitor, INF904. The safety analysis of INF904 in the Phase I study demonstrated that it was well tolerated in participants over the entire dose range and resulted in no safety signals of concern. There were no serious or severe adverse events observed at any dosing level. Both the single ascending dose and the MAD part of the study showed favorable PK and PD profiles, including achieving the desired blocking activity (>90%) of C5a-induced neutrophil activation in an ex vivo challenge assay using physiological and disease-relevant levels of C5a. Vilobelimab in PG – Enrollment ongoing in pivotal Phase III trialInflaRx is conducting a multi-national, randomized, double-blind, placebo-controlled pivotal Phase III study of vilobelimab for the treatment of ulcerative PG, a rare, chronic inflammatory form of neutrophilic dermatosis characterized by accumulation of neutrophils in the affected skin areas. The trial has two arms: (1) vilobelimab plus a low dose of corticosteroids and (2) placebo plus the same low dose of corticosteroids. The primary endpoint of the study is complete closure of the target ulcer at any time up to 26 weeks after initiation of treatment. The study has an adaptive design with an interim analysis blinded for the sponsor and investigators planned upon enrollment of approximately 30 patients (15 per arm). Depending on the results of the interim analysis, expected to occur in 2025, the trial sample size will be adapted, or the trial will be terminated due to futility. The total enrollment period is projected to be at least two years, depending 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. GOHIBIC (vilobelimab) for the treatment of critically ill COVID-19 patients – The InflaRx Commitment Program launchedIn April, 2023, the FDA issued an Emergency Use Authorization (EUA) for GOHIBIC (vilobelimab) for the treatment of COVID-19 in hospitalized adults when initiated within 48 hours of receiving invasive mechanical ventilation (IMV) or extracorporeal membrane oxygenation (ECMO). In January 2024, InflaRx announced the launch of The InflaRx Commitment Program, pursuant to which the cost of GOHIBIC (vilobelimab) will be refunded for up to six (6) administered inpatient doses (the full treatment course) to institutions that meet the eligibility requirements*, for patients who were administered GOHIBIC (vilobelimab) in line with its EUA and who died due to COVID-19 in the intensive care unit. InflaRx continues to explore funding options for vilobelimab as a treatment for acute respiratory distress syndrome (ARDS), including government grants as well as collaborations with third parties. The Marketing Authorization Application (MAA) for the treatment of adult patients with SARS-CoV-2 induced septic ARDS receiving IMV or ECMO is under regulatory review by the European Committee for Medicinal Products for Human Use under the centralized procedure, which applies to all 27 member states of the European Union. Vilobelimab abstract presentation at ATS 2024An InflaRx abstract titled “Vilobelimab in Combination With Tocilizumab or Baricitinib Dramatically Improves Mortality in Critically Ill COVID-19 Patients: A Subgroup Analysis” has been accepted for presentation during a thematic poster session at the American Thoracic Society 2024 International Conference on Tuesday, May 21, from 11:30 AM PT / 2:30 PM ET / 8:30 PM CEST to 1:15 PM PT / 4:15 PM ET / 10:15 PM CEST. Dr. Thomas Taapken, Chief Financial Officer of InflaRx, said: “In the first quarter of 2024, InflaRx strategically prioritized its efforts, focusing development activities in a select number of immuno-dermatology indications. Sharpening our profile in this way has helped put us in a strong financial position, allowing us to advance our clinical programs towards their next milestones and to fund operations at least into 2026.” Financial Highlights – Q1 2024 RevenueFor the three months ended March 31, 2024, we realized revenues from the product sales of GOHIBIC (vilobelimab) in the amount of €36 thousand. Revenues reported are sales to end customers (hospitals). Sales to distributors do not constitute revenue for the InflaRx under IFRS 15. All revenues are attributed to sales made in the United States. Cost of salesThe cost of sales during the three months ended March 31, 2024 mainly consists of write-downs of inventories that will expire prior to their expected sale. Sales and marketing expenses In the three months ended March 31, 2024, we incurred €1.5 million of sales and marketing expenses. These expenses are primarily comprised of €0.3 million in personnel costs and €0.7 million in external services for distribution. R&D expenses R&D expenses incurred for the three months ended March 31, 2024 decreased by €7.4 million compared to the three months ended March 31, 2023. This decrease is primarily due to the fact that we incurred high third-party expenses in the first quarter of 2023 in connection with our efforts to develop the commercial manufacturing process and to obtain an EUA for GOHIBIC (vilobelimab). General and administrative expenses General and administrative expenses amounted to €3.6 million for each of the three months ended March 31, 2024 and March 31, 2023. Other incomeOther income for the three months ended March 31, 2024 amounted to €36 thousand (PY: €7.7 million). The decrease of €7.7 million in other income is due to the end of the government grant period on June 30, 2023. Net financial result Net financial result increased by €3.3 million to a gain of €2.8 million for the three months ended March 31, 2024 from a loss of €0.5 million for the three months ended March 31, 2023. This increase is mainly attributable to an increase of interest income on marketable securities by €0.5 million and an increase of foreign exchange result of €3.0 million. Other financial result consists of an adjustment for expected credit losses on marketable securities. Net lossNet loss for the first three months of 2024 amounted to €9.7 million, compared to €11.1 million in the first three months of 2023. Net cash used in operating activitiesNet cash used in operating activities for the first three months of 2024 increased to €14.9 million from €10.5 million for the comparable period in 2023. Liquidity and capital resourcesAs of March 31, 2024, InflaRx’s total available funds were approximately €85.8 million, composed of €25.1 million in cash and cash equivalents and €60.7 million in marketable securities. These funds are expected to finance operations at least into 2026. Additional financial informationAdditional information regarding these results and other relevant information is included in the notes to the unaudited interim condensed consolidated financial statements as of March 31, 2024, as well as the consolidated financial statements as of and for the year ended December 31, 2023, in “ITEM 18. Financial Statements,” in InflaRx’s Annual Report on Form 20-F for the year ended December 31, 2023, as filed with the U.S. Securities and Exchange Commission (SEC) on March 21, 2024. InflaRx N.V. and subsidiariesUnaudited condensed consolidated statements of operations and comprehensive loss for the three months ended March 31, 2024 and 2023 For the three months ended March 31, 2024(unaudited) 2023(unaudited) (in €, except for share data) Revenues36,037 — Cost of sales(220,521) — Gross profit(184,484) — Sales and marketing expenses(1,459,539) — Research and development expenses(7,301,810) (14,731,908)General and administrative expenses(3,579,150) (3,608,554)Other income36,323 7,746,189 Other expenses(30) (566)Operating result(12,488,690) (10,594,839)Finance income908,426 456,036 Finance expenses(4,632) (5,528)Foreign exchange result1,824,375 (1,137,310)Other financial result103,285 197,808 Income taxes— — Income (loss) for the period(9,657,236) (11,083,833)Other comprehensive income (loss) that may be reclassified to profit or loss in subsequent periods: Exchange differences on translation of foreign currency(25,538) (16,785)Total comprehensive income (loss)(9,682,774) (11,100,618) Share information (based on income (loss) for the period) Weighted average number of shares outstanding58,883,272 44,771,703 Income (loss) per share (basic/diluted)(0.17) (0.25) InflaRx N.V. and subsidiariesUnaudited condensed consolidated statements of financial position as of March 31, 2024 and December 31, 2023 March 31, 2024(unaudited) December 31, 2023 (in €)ASSETS Non-current assets Property and equipment284,043 289,577 Right-of-use assets1,056,966 1,071,666 Intangible assets52,145 68,818 Other assets244,009 257,267 Financial assets2,490,202 9,052,741 Total non-current assets4,127,365 10,740,069 Current assets Inventories11,048,645 11,367,807 Current other assets5,869,744 4,036,650 Trade receivables35,242 — Tax receivable2,098,276 3,791,564 Other financial assets58,812,905 77,504,518 Cash and cash equivalents25,103,058 12,767,943 Total current assets102,967,870 109,468,483 TOTAL ASSETS107,095,235 120,208,552 EQUITY AND LIABILITIES Equity Issued capital7,065,993 7,065,993 Share premium334,211,338 334,211,338 Other capital reserves41,910,754 40,050,053 Accumulated deficit(295,785,055) (286,127,819)Other components of equity7,356,629 7,382,166 Total equity94,759,658 102,581,730 Non-current liabilities Lease liabilities727,058 745,716 Other liabilities36,877 36,877 Total non-current liabilities763,935 782,593 Current liabilities Trade and other payables7,607,757 11,974,362 Lease liabilities378,089 374,329 Employee benefits637,607 1,609,766 Other liabilities2,948,189 2,885,772 Total current liabilities11,571,642 16,844,229 Total liabilities12,335,557 17,626,822 TOTAL EQUITY AND LIABILITIES107,095,235 120,208,552 InflaRx N.V. and subsidiariesUnaudited condensed consolidated statements of changes in shareholders’ equity for the three months ended March 31, 2024 and 2023 (in €)Issuedcapital Sharepremium Othercapitalreserves Accumulateddeficit Other componentsof equity Total equity Balance as of January 1, 20247,065,993 334,211,338 40,050,053 (286,127,819) 7,382,166 102,581,730 Loss for the period— — — (9,657,236) — (9,657,236)Exchange differences on translation of foreign currency— — — — (25,538) (25,538)Total comprehensive loss— — — (9,657,236) (25,538) (9,682,774)Equity-settled share-based payments— — 1,860,701 — — 1,860,701 Balance as of March 31, 20247,065,993 334,211,338 41,910,754 (295,785,055) 7,356,629 94,759,658 Balance as of January 1, 20235,364,452 282,552,633 36,635,564 (243,460,290) 7,257,081 88,349,440 Loss for the period— — — (11,083,833) — (11,083,833)Exchange differences ontranslation of foreign currency— — — — (16,785) (16,785)Total comprehensive loss— — — (11,083,833) (16,785) (11,100,618)Equity-settled share-based payments— — 1,207,048 — — 1,207,048 Share options exercised8,548 115,399 — — — 123,947 Balance as of March 31, 20235,373,000 282,668,032 37,842,612 (254,544,123) 7,240,295 78,579,816 InflaRx N.V. and subsidiariesUnaudited condensed consolidated statements of cash flows for the three months ended March 31, 2024 and 2023 For the three months ended March 31, 2024(unaudited) 2023(unaudited) (in €)Operating activities Loss for the period(9,657,236) (11,083,833)Adjustments for: Depreciation & amortization of property and equipment, right-of-use assets and intangible assets123,949 147,969 Net finance income (expense)(2,831,454) 488,994 Share-based payment expense1,860,701 1,207,048 Net foreign exchange differences(119,126) (106,793)Changes in: Financial assets from government grants— (2,701,076)Inventories319,162 — Trade receivables(35,242) — Employee benefits(972,159) (834,713)Other assets(126,547) 7,515,105 Other liabilities62,417 15,986 Liabilities from government grants received— (5,033,779)Trade and other payables(4,366,605) (371,445)Interest received875,990 245,971 Interest paid(2,214) (5,627)Net cash used in operating activities(14,868,364) (10,516,193)Investing activities Purchase of intangible assets, property and equipment(16,069) (6,046)Purchase of current financial assets(3,566,235) (25,120,832)Proceeds from the maturity of financial assets30,527,108 21,540,578 Net cash from/(used in) investing activities26,944,804 (3,586,300)Financing activities Proceeds from exercise of share options— 123,947 Repayment of lease liabilities(85,706) (93,744)Net cash from/(used in) financing activities(85,706) 30,202 Net increase/(decrease) in cash and cash equivalents11,990,733 (14,072,291)Effect of exchange rate changes on cash and cash equivalents344,381 (95,814)Cash and cash equivalents at beginning of period12,767,943 16,265,355 Cash and cash equivalents at end of period25,103,058 2,097,250 About InflaRxInflaRx GmbH (Germany) and InflaRx Pharmaceuticals Inc. (USA) are wholly owned subsidiaries of InflaRx N.V. (together, InflaRx). 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 product candidate, vilobelimab, is 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 in different indications. InflaRx is also developing INF904, an orally administered, small molecule inhibitor of the C5a receptor. 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.com. Contacts: InflaRx N.V.MC Services AGJan Medina, CFAVice President, Head of Investor RelationsEmail: IR@inflarx.deKatja Arnold, Laurie Doyle, Dr. Regina LutzEmail: inflarx@mc-services.eu Europe: +49 89-210 2280U.S.: +1-339-832-0752 FORWARD-LOOKING STATEMENTSThis 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,” “project,” “estimate,” “believe,” “predict,” “potential” or “continue,” among others. Forward-looking statements appear in a number of places throughout this release and may include statements regarding our intentions, beliefs, projections, outlook, analyses and current expectations concerning, among other things, the receptiveness of GOHIBIC (vilobelimab) as a treatment for COVID-19 by COVID-19 patients and U.S. hospitals and related treatment recommendations by medical/healthcare institutes and other third-party organizations, our ability to successfully commercialize and the receptiveness of GOHIBIC (vilobelimab) as a treatment for COVID-19 by COVID-19 patients and U.S. hospitals or our other product candidates; 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 an EUA and in the future if approved for commercial use in the United States or elsewhere; our ability to successfully implement The InflaRx Commitment Program, the success of our future clinical trials for vilobelimab’s treatment of COVID-19 and other debilitating or life-threatening inflammatory indications, including 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 pre-clinical studies and clinical trials of our product candidates 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 regulators regarding the results of clinical trials and potential regulatory approval pathways, including related to our MAA submission for vilobelimab and our BLA submission for GOHIBIC (vilobelimab), and our ability to obtain and maintain full regulatory approval of vilobelimab or GOHIBIC (vilobelimab) for any indication; whether the FDA, the 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; our expectations regarding the scope of any approved indication for vilobelimab; our ability to leverage our proprietary anti-C5a and 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 and any other product candidates, and the scope of such protection; 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); our estimates of our expenses, ongoing losses, future revenue, capital requirements and our needs for or ability to obtain additional financing; our ability to defend against liability claims resulting from the testing of our product candidates in the clinic or, if approved, any commercial sales; if any of our product candidates obtain regulatory approval, our ability to comply with and satisfy ongoing obligations and continued regulatory overview; our ability to comply with enacted and future legislation in seeking marketing approval and commercialization; our future growth and ability to compete, which depends on our retaining key personnel and recruiting additional qualified personnel; and our competitive position and the development of and projections relating to our competitors in the development of C5a and C5aR inhibitors or our industry; and the risks, uncertainties and other factors described under the heading “Risk Factors” in our periodic filings with the SEC. 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.