Gingivitis, Necrotizing Ulcerative

Ainos and SIDSCO will cooperate to accelerate the development of new animal drugs based on Ainos' VELDONA® low-dose oral interferon Upcoming clinical study will investigate VELDONA®'s safe use and efficacy for the treatment of feline chronic gingivostomatitis (FCGS) via oral mucosal administration SAN DIEGO, CA / ACCESSWIRE / November 6, 2023 / Ainos, Inc. (NASDAQ:AIMD, AIMDW) ("Ainos", or the "Company"), a diversified healthcare company focused on the development of AI-powered point-of-care testing, low-dose interferon therapeutics, and synthetic RNA-driven preventative medicine, today announced that it had signed a Memorandum of Understanding ("MoU") with SIDSCO Biomedical Co., Ltd. ("SIDSCO"). The MoU is an important step in Ainos' strategy to expand its product line into the global pet care market. Under the agreement, Ainos and SIDSCO (collectively, the "Parties") will jointly explore the feasibility of VELDONA®/Cytoprotein contract clinical trials. Ainos intends to conduct animal clinical trials for veterinary investigational medicines in conjunction with SIDSCO, and will provide the technical knowledge, funding, and assistance required for the project. Ainos' low-dose oral interferon alpha ("IFNα") formulation, VELDONA®, is a human interferon first approved for sale by the Texas Department of Health in 1985 for the treatment of cats with feline leukemia and dogs with canine parvovirus. In 28 previous studies performed by Ainos, VELDONA® was found to exhibit systemic effects in mice, cats, dogs, ferrets, chickens, rats, guinea pigs, horses, calves/cows, and particularly pigs. VELDONA® has aided in boosting feed conversion efficiency and fighting deadly viral infections in these species, including canine parvovirus, equine herpesvirus, feline coronavirus, and others. These studies demonstrate that VELDONA® has a therapeutic or preventive effect via the oral mucosa. At the same time, VELDONA® modulates systemic and mucosal immunity without serious side effects. Previous studies have confirmed that feline interferon administered to the local oral mucosa can improve the clinical symptoms of pain in cats and the degree of inflammation in the affected area, and no serious adverse drug reactions occurred during the trial period. The experience of many veterinarians using over-the-counter medications has also shown that many cases of feline chronic gingivostomatitis (FCGS) have been significantly improved through the use of interferons. It can be seen that interferon has a good effect on chronic gingivostomatitis in cats, and it has no adverse effects when used in combination with other drugs. The results of the Agricultural Science and Technology Research Institute's potency and cytotoxicity tests on VELDONA® using feline macrophages (fcwf-4) confirmed its antiviral efficacy and established an effective and safe dosage. Ainos' upcoming clinical trial, expected to be held in cooperation with SIDSCO at Mercy Animal Medical Center, will investigate VELDONA®'s safe use and efficacy for the treatment of FCGS in cats via oral mucosal administration. FCGS is characterized by severe inflammation of the gingiva, buccal mucosa, and caudal oral mucosa. There are two types of FCGS. Type 1 includes cases with alveolar and labial/buccal mucositis/stomatitis only, while Type 2 covers cases with caudal mucositis/stomatitis, with or without alveolar and labial/buccal mucositis/stomatitis. The exact cause of FCGS is still unknown. It seems that cats with FCGS have a hyperimmune reaction to plaque, bacteria, viruses, or environmental factors which leads to excessive inflammation. FCGS is a common condition, with a reported prevalence ranging from 0.7% to 12.0%. The most favorable clinical control for resolution of oral inflammation is via partial or full mouth complete tooth extractions. Dental extractions have been shown to cure FCGS in 55% of cases, markedly improve symptoms in 35% of cases, and have no effect in 10% of cases. Refractory FCGS requires lifelong medication, including immunosuppressants such as corticosteroids or cyclosporine, or immunomodulators such as Feline Interferon Omega. However, due to the potential deleterious side-effects of long-term corticosteroid administration, these should only be used as needed for symptomatic alleviation during the acute phase. Currently, medical management of FCGS remains highly variable and often depends on comorbidities in each individual case. Generally, existing medical therapies for FCGS include antibiotics, antihistamines, and immunosuppressants, such as corticosteroids or cyclosporine, which are often first-line treatments for affected animals. However, these immunosuppressants have serious long-term side effects, including type 2 diabetes and opportunistic infections. Currently, there are no medications for animals that do not respond to anti-inflammatory or immunosuppressive treatments, and there are no ideal long-term solutions available to pet owners. A report compiled by Grand View Research shows that the global pet dental health market is projected to grow at a CAGR of 6.2%, reaching US$9.98 billion by 2030. The canine market segment accounted for the largest revenue share at over 55.0%, and the feline market segment is anticipated to expand at a CAGR of 6.9%. Cat ownership in the United States is estimated at 85.5 million, suggesting that as many as 10.3 million cats have FCGS. Companion animal ownership continues to rise in the United States, especially among young people. About 35% of American households own a cat. In addition to Taiwan, Ainos is actively working to take advantage of larger market opportunities with sales in Asia and the United States. Ainos' upcoming clinical trial is expected to be sent to the United States' Internal Animal Care and Use Committee (IACUC) for review in December this year. The clinical trial is a small-scale field pre-trial. It is expected to start accepting cases in the first quarter of next year, and to complete admission of 15-30 cats in the second quarter. If the results of this trial meet the expected efficacy requirements, the Company will submit a formal application to Taiwan's Bureau of Prevention and Inspection of the Ministry of Agriculture for animal new drug field trials. This would represent a significant step forward in the process of obtaining an animal new drug license. Ainos plans to conduct the upcoming clinical study in cooperation with SIDSCO at Mercy Animal Medical Center. Chun-Hsien (Eddy) Tsai, Chairman of the Board, President, and Chief Executive Officer of Ainos, commented, "We are thrilled to be taking this significant step in the further advancement of VELDONA® within the pet health space. The global pet care market is massive, estimated at $223 billion in 2021, making this the perfect time for us to expand our VELDONA® portfolio to include a potential treatment option for one of the most common ailments among domestic cats. By signing this MoU with SIDSCO, we are intent on accelerating the drug development process, and we believe our collaboration will bring substantial benefits to both parties. We remain steadfast in our commitment to providing pet owners with safe and effective solutions to safeguard their animals' health, and I look forward to our team working side-by-side with SIDSCO to make this goal a reality." About Ainos, Inc. Headquartered in San Diego, California, Ainos is a diversified healthcare company focused on the development of novel point-of-care testing ("POCT"), low-dose VELDONA® interferon therapeutics, and synthetic RNA-driven preventative medicine. The company's products include VELDONA® clinical-stage human therapeutics, VELDONA® Pet cytoprotein health supplements, and telehealth-friendly POCTs powered by its AI Nose technology platform. The lead POCT candidate, Ainos Flora, is intended to be a telehealth-friendly POCT for women's health and certain common sexually transmitted infections ("STIs"). To learn more, visit . Follow Ainos on X, formerly known as Twitter, (@AinosInc) and LinkedIn to stay up-to-date. About SIDSCO Biomedical Co., Ltd SIDSCO, which stands for Scientific Integration Design Service Corporation, is a Taiwanese contract research organization (CRO) founded in 2018. SIDSCO focuses on providing systematic and customized preclinical experimental integration outsourcing services, which include experiment design, material preparation, experiment execution, report writing, and evidence counseling. SIDSCO is fully accredited by the Association for Assessment and Accreditation of Laboratory Animal Care, International (AAALAC), and has been certified for both OECD GLP and TFDA GLP. Visit for more information. About Mercy Animal Medical Center Founded in 1998, Mercy Animal Medical Center's mission is to safeguard animals' medical care and to educate pet owners about better animal health. It currently employs 60 specialized veterinarians to diagnose and treat a wide range of pets, including rabbits, rodents, snakes, lizards, turtles, parrots, sugar gliders, raccoons, hedgehogs, and more. It is equipped with advanced instruments and benefits from professional collaboration with specialized departments, ensuring that every patient receives the most appropriate medical care. Mercy Animal Center is affiliated with Jong-Shing Animal Hospital. Visit for more information. Forward-Looking Statements This press release contains "forward-looking statements" about Ainos within the meaning of the safe harbor provisions of the U.S. Private Securities Litigation Reform Act of 1995. Forward-looking statements can be identified by the use of words such as "anticipate," "believe," "estimate," "approximate," "expect," "intend," "plan," "predict," "project," "target," "future," "likely," "strategy," "foresee," "may," "guidance," "potential," "outlook," "forecast," "should," "will" or other similar words or phrases. Similarly, statements that describe the Company's objectives, plans or goals are, or may be, forward-looking statements. Forward-looking statements are based only on the Company's current beliefs, expectations, and assumptions. Forward-looking statements are subject to inherent uncertainties, risks, and changes in circumstances that are difficult to predict and many of which are outside of the Company's control. The Company's actual results may differ materially from those indicated in the forward-looking statements. Important factors that could cause the Company's actual results to differ materially from the projections, forecasts, estimates and expectations discussed in this press release include, among others, the cost of production and sales potential of the planned drug treatments announced in this press release; the Company's dependence on projected revenues from the sale of COVID-19 test kits and its VELDONA® Pet line of supplements ; the Company's limited cash and history of losses; the Company's ability to achieve profitability; the Company's ability to raise additional capital to continue the Company's product development; the ability to accurately predict the future operating results of the Company; the ability to advance Ainos' current or future product candidates through clinical trials, obtain marketing approval and ultimately commercialize any product candidates the Company develops; the ability to obtain and maintain regulatory approval of Ainos' product candidates; delays in completing the development and commercialization of the Company's current and future product candidates, which could result in increased costs to the Company, delay or limit the ability to generate revenue and adversely affect the business, financial condition, results of operations and prospects of the Company; intense competition and rapidly advancing technology in the Company's industry that may outpace its technology; customer demand for the products and services the Company develops; the impact of competitive or alternative products, technologies and pricing; disruption in research and development facilities; lawsuits and other claims by third parties or investigations by various regulatory agencies governing the Company's operations; potential cybersecurity attacks; increased requirements and costs related to cybersecurity; the Company's ability to realize the benefits of third party licensing agreements; the Company's ability to obtain and maintain intellectual property protection for Ainos product candidates; compliance with applicable laws, regulations and tariffs; continued listing on and compliance with the applicable regulations of the Nasdaq Capital Market; and the Company's success in managing growth. A more complete description of these risk factors and others is included in the "Risk Factors" section of Ainos' Annual Report on Form 10-K for the year ended December 31, 2022 and other reports filed with the U.S. Securities and Exchange Commission ("SEC"), many of which risks are beyond the Company's control. In addition to the risks described above and in the Company's reports filed with the SEC, other unknown or unpredictable factors also could cause actual results to differ materially from the projections, forecasts, estimates and expectations discussed in this press release. The forward-looking statements made in this press release are expressly qualified in their entirety by the foregoing cautionary statements. Ainos undertakes no obligation to, and expressly disclaims any such obligation to, publicly update or revise any forward-looking statement to reflect changed assumptions, the occurrence of anticipated or unanticipated events or changes to the future results over time or otherwise, except as required by law. Investor Relations Contact ICR, LLC Robin Yang Tel: +1 646-224-6971 Email: Ainos.IR@icrinc.com SOURCE: Ainos, Inc. View source version on accesswire.com:

• Quarter highlighted by the Emergency Use Authorization (EUA) and commercial launch of Gohibic (vilobelimab) in the United States • Oral C5aR inhibitor INF904 progressing in single ascending dose (SAD) and multiple ascending dose (MAD) Phase I trial • Progress in clinical development of vilobelimab in other indications, including cutaneous squamous cell carcinoma (cSCC) and pyoderma gangrenosum (PG) • Strong addition to management team as Camilla Chong, M.D., joins as Chief Medical Officer • Cash, cash equivalents and marketable securities of €115.2 million, expected to fund operations at least into 2026 JENA, Germany, Aug. 10, 2023 (GLOBE NEWSWIRE) -- InflaRx N.V. (Nasdaq: IFRX), a clinical-stage biopharmaceutical company developing and commercializing anti-inflammatory therapeutics by targeting the complement system, announced today financial results for the three and six months ended June 30, 2023 and provided an operating update. “It was truly thrilling to launch Gohibic (vilobelimab) for the treatment of certain critically ill COVID-19 patients in the United States and to be in the position of making our drug available for patients in U.S. hospitals,” said Prof. Niels C. Riedemann, Chief Executive Officer and Founder of InflaRx. “Our development work in other disease areas where C5a and C5aR may play a significant role is progressing well as we strive to make Gohibic (vilobelimab) available to other patients who may benefit from it and to further our C5aR inhibitor INF904 into research in additional disease areas. Today, we also announced first data from an ongoing clinical trial in cutaneous squamous cell carcinoma.” He continued: “With all the important work ahead, I am very pleased that Dr. Camilla Chong has joined the team to drive our future clinical development work with both vilobelimab and our oral C5aR inhibitor INF904. With her impressive background in the pharmaceutical industry, including her experience in launching new pharmaceutical products, she will be instrumental in advancing our complement-targeting therapies through the clinic and ultimately into the market.” Recent Highlights and Business Update Camilla Chong, M.D. joins InflaRx as Chief Medical Officer: Dr. Camilla Chong was appointed as Chief Medical Officer, effective July 1, 2023. She is a medical doctor with 25 years of experience in the global pharmaceutical industry. Dr. Chong has successfully led clinical development, medical affairs, clinical operations, regulatory and pharmacovigilance teams and has managed global clinical development programs. She has extensive experience in the launch of many new pharmaceutical products in multiple geographies. She joined InflaRx from Kyowa Kirin Corporation, where she was Vice President and Global Medical Affairs Therapy Area Head - Immunology. Dr. Chong is leading all clinical development activities at InflaRx. Commercial Launch of Gohibic (vilobelimab) for the Treatment of Critically ill COVID-19 Patients following the EUA in the United States: In April 2023, the U.S. Food and Drug Administration (FDA) issued an 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). Gohibic (vilobelimab) has been commercially available to hospitals across the United States since late Q2. InflaRx is building an experienced and highly focused commercial team to support the drug's launch and distribution to hospitals. At the same time, the Company has set up a robust supply chain to allow for uninterrupted supply of Gohibic to the U.S. market. Lastly, InflaRx is raising awareness for this treatment option in the medical community through dedicated medical information campaigns. Further, the Company is continuing discussions with the FDA related to the submission of a Biologics License Application (BLA) for a potential future full approval of Gohibic (vilobelimab) in the United States. InflaRx has also completed encouraging meetings with the rapporteur and co-rapporteur member state teams of the European Committee for Medicinal Products for Human Use (CHMP) related to a planned Marketing Authorization Application with the European Medicines Agency (EMA). The Company will provide updates on the status of regulatory submissions in the United States and elsewhere once available. Development of Vilobelimab in Pyoderma Gangrenosum (PG): In January 2023, InflaRx presented details related to the design of its planned pivotal Phase III study with vilobelimab in ulcerative PG, following compelling Phase II results for the treatment of this rare neutrophilic and inflammatory skin disease with destructive, painful cutaneous ulcers. The multi-national, randomized, double-blind, placebo-controlled trial has an adaptive design with an interim analysis that will determine the planned total patient number. InflaRx submitted a Phase III clinical trial protocol to the FDA, initiated the preparatory activities and expects the first patient to be enrolled in Q3 2023. INF904 – Low Molecular Weight, Oral C5aR Inhibitor: InflaRx is currently conducting a single (SAD) and multiple ascending dose (MAD) Phase I clinical trial in healthy volunteers to assess the safety, tolerability and pharmacokinetic / pharmacodynamic properties of InflaRx’ new and proprietary low molecular weight C5aR inhibitor INF904. The Company plans to show the effect of INF904 on C5a-induced downstream activity and to generate data in a format comparable with other published data on C5aR inhibitory molecules like avacopan. Results from the SAD part of the study are expected for Q3 2023 and results from the MAD part of the study are expected in Q4 2023. In the future, InflaRx plans to develop INF904 for complement-mediated, chronic autoimmune and inflammatory diseases where oral administration is the preferred choice for patients. Initial Results for Development of Vilobelimab in Cutaneous Squamous Cell Carcinoma: InflaRx is conducting an open-label, multicenter Phase II study, evaluating vilobelimab in two study arms - as stand-alone therapy (Arm A) and in combination with pembrolizumab (Arm B) - in patients with programmed cell death protein 1 (PD1) or programmed cell death ligand 1 (PDL1) inhibitor resistant/refractory, locally advanced or metastatic cutaneous squamous cell carcinoma (cSCC). The main objectives of this trial are to assess the safety and antitumor activity of vilobelimab in the monotherapy arm and to assess the maximum tolerated or recommended dose of vilobelimab and the safety and antitumor activity of this drug pair in the combination arm. An interim analysis of ten evaluable patients in the monotherapy Arm A, which was not powered for significance due to the small number of patients in this cohort, showed first evaluable signals of efficacy: one patient had a complete response and another patient displayed overall stable disease; and a third patient showed stable disease of the target lesion according to “Response Evaluation Criteria In Solid Tumors” (RECIST) criteria. Vilobelimab treatment did not result in signals of concern related to safety or tolerability in these patients with advanced cSCC, who typically are of higher age and frequently suffer from multiple comorbidities. In Arm B, patients are currently being enrolled and treated in the highest dose cohort. An interim analysis is planned to be performed once ten patients in the highest dose cohort are evaluable for response assessment. So far, six patients have been enrolled, and the interim results are expected to be available in H1 2024. The decision on whether to progress to stage two of the study in arms A and/or B will be taken once the efficacy analysis in Arm B has been completed. Although generally, cSCC patients can be effectively treated, some patients become resistant or refractory to current treatment options. Those patients have very high fatality rates and currently no approved treatment options. Based on these first encouraging activity signals in this difficult to treat patient population, the Company will decide on next development steps once more results of the combination arm where patients receive a PD-1 inhibitor in addition to vilobelimab become available. Financing Activities In April 2023, the Company issued 3,235,723 ordinary shares under its ATM program, resulting in €14.4 million in net proceeds. Also in April 2023, the Company completed an underwritten public offering of an aggregate of 10,823,529 ordinary shares, of which 1,411,764 were sold pursuant to the full exercise of an overallotment option granted to the underwriters. The ordinary shares were sold at a price of $4.25 per share and have a nominal value of €0.12 per share. Aggregate proceeds from these equity offerings amounted to €53.5 million after deducting underwriting discounts. On July 12, 2023, InflaRx filed a shelf registration statement on Form F-3 with the U.S. Securities and Exchange Commission (SEC) in order to replace its expiring shelf registration statement and to authorize the issuance of up to $250 million in securities in registered offerings. Dr. Thomas Taapken, Chief Financial Officer of InflaRx, said: “It is an exciting time for InflaRx as we evolve into a commercial-stage company and build a strong team to support the commercialization of Gohibic. However, with the lower numbers of severe COVID-19 cases, which we are grateful for, we are expecting moderate demand and first revenues in H2 2023. Thanks to our recent successful financing activities, we are well positioned to invest in the necessary infrastructure to make Gohibic available to hospitals across the United States, in addition to supporting our clinical development activities, including the Phase III trial with vilobelimab in pyoderma gangrenosum and the future development of our promising C5aR inhibitor INF904. Despite a financial market environment that has remained highly challenging, we are well funded to support our operations well into 2026.” Financial Highlights – Q2 2023 Research and Development Expenses Research and development expenses incurred in H1 2023 increased compared to the corresponding period in 2022 by €4.0 million. This increase was primarily due to higher third-party expenses of €3.7 million related to manufacturing, development and regulatory activities in conjunction with the EUA application for vilobelimab in COVID-19. General and Administrative Expenses General and administrative expenses in H1 2023 decreased by €1.6 million to €7.1 million from €8.7 million in H1 2022. This decrease was primarily attributable to decreasing expenses associated with equity-settled share-based compensation recognized in personnel expenses. Sales and Marketing Expenses During H1 2023, InflaRx reported sales and marketing expenses for the first time, which amounted to €0.3 million, as a result of the initiation of the commercialization of Gohibic (vilobelimab). These expenses were mainly comprised of €0.1 million in personnel costs and €0.1 million in external distribution services. Other Income Other income, which was primarily derived from income from government grants, decreased by €1.8 million to €12.6 million for the first half of 2023, from €14.4 million for the comparable period in 2022. The decrease was primarily due to the absence of a non-recurring catch-up effect of costs incurred in periods before Q2 2022, for which income recognition was deferred until Q3 2022, when the recognition criteria were considered to be met. Net Financial Result Net financial result decreased by €1.2 million to €1.2 million for the six months ended June 30, 2023, from €2.4 million in the same period of 2022. This decrease was mainly attributable to lower foreign exchange results which decreased by €2.7 million, partly compensated by the increase in interest income of €1.4 million due to increased interest payments from marketable securities. Net Loss Net loss in H1 2023 amounted to €19.3 million, compared to €13.5 million in H1 2022. Net Cash Used in Operating Activities Net cash used in operating activities in H1 2023 decreased to €21.7 from €25.4 million in H1 2022. Liquidity and Capital Resources As of June 30, 2023, the Company’s total available funds were approximately €115.2 million, composed of €19.5 million in cash and cash equivalents and €95.7 million in marketable securities. These funds are expected to finance operations at least into 2026. Additional Financial Information Additional information regarding these results and other relevant information is included in the notes to the unaudited interim condensed consolidated financial statements as of June 30, 2023, and the three and six months ended June 30, 2023, and 2022, as well as the consolidated financial statements as of and for the year ended December 31, 2022, in “ITEM 18. Financial Statements,” in InflaRx’s Annual Report on Form 20-F for the year ended December 31, 2022, as filed with the SEC. InflaRx N.V. and subsidiaries Unaudited Condensed Consolidated Statements of Operations and Comprehensive Loss for the three and six months ended June 30, 2023 and 2022 For the three months ended June 30, For the six months ended June 30, 2023 (unaudited) 2022 (unaudited) 2023 (unaudited) 2022 (unaudited) (in €, except for share data) Research and development expenses (10,919,595 ) (11,180,958 ) (25,651,503 ) (21,652,881 ) General and administrative expenses (3,540,805 ) (4,346,965 ) (7,149,359 ) (8,734,408 ) Sales and marketing expenses (276,051 ) — (276,051 ) — Other income 4,882,908 14,441,541 12,629,096 14,443,135 Other expenses (2,624 ) (279 ) (3,190 ) (844 ) Operating Result (9,856,168 ) (1,086,661 ) (20,451,007 ) (15,944,999 ) Finance income 1,087,011 82,401 1,543,047 110,362 Finance expenses (5,052 ) (7,945 ) (10,580 ) (32,531 ) Foreign exchange result 767,646 1,563,580 (369,664 ) 2,291,513 Other financial result (195,567 ) (86,000 ) 2,241 39,000 Income Taxes — — — — Income (Loss) for the Period (8,202,130 ) 465,376 (19,285,963 ) (13,536,654 ) Share Information Weighted average number of shares outstanding 56,985,734 44,203,763 50,912,459 44,203,763 Income (Loss) per share (basic/diluted) (0.14 ) 0.01 (0.38 ) (0.31 ) Other comprehensive income (loss) that may be reclassified to profit or loss in subsequent periods: Exchange differences on translation of foreign currency (330 ) 4,408,940 (17,116 ) 5,718,815 Total Comprehensive Income (Loss) (8,202,460 ) 4,874,316 (19,303,079 ) (7,817,839 ) InflaRx N.V. and subsidiaries Unaudited Condensed Consolidated Statements of Financial Position as of June 30, 2023 and December 31, 2022 June 30, 2023 (unaudited) December 31, 2022 (in €) ASSETS Non-current assets Property and equipment 296,382 328,920 Right-of-use assets 1,122,183 1,311,809 Intangible assets 90,789 138,905 Other assets 283,784 308,066 Financial assets 18,951,267 2,900,902 Total non-current assets 20,744,405 4,988,602 Current assets Inventories 578,705 — Current other assets 6,405,867 14,170,510 Current tax assets 2,925,037 1,732,087 Financial assets from government grants 5,193,246 732,971 Other financial assets 77,601,286 64,810,135 Cash and cash equivalents 19,515,959 16,265,355 Total current assets 112,220,100 97,411,058 TOTAL ASSETS 132,964,505 102,399,660 EQUITY AND LIABILITIES Equity Issued capital 7,065,993 5,364,452 Share premium 334,211,338 282,552,633 Other capital reserves 38,874,961 36,635,564 Accumulated deficit (262,746,253 ) (243,460,290 ) Other components of equity 7,239,965 7,257,081 Total equity 124,646,004 88,349,440 Non-current liabilities Lease liabilities 814,560 987,307 Other liabilities 36,877 36,877 Total non-current liabilities 851,437 1,024,184 Current liabilities Trade and other payables 5,200,809 4,987,538 Liabilities from government grants 801,632 6,209,266 Lease liabilities 356,099 369,376 Employee benefits 900,474 1,312,248 Other liabilities 208,051 147,608 Total current liabilities 7,467,065 13,026,036 Total Liabilities 8,318,502 14,050,220 TOTAL EQUITY AND LIABILITIES 132,964,505 102,399,660 InflaRx N.V. and subsidiaries Unaudited Condensed Consolidated Statements of Changes in Shareholders’ Equity for the six months ended June 30, 2023 and 2022 (in €) Issued capital Share premium Other capital reserves Accumulated deficit Other components of equity Total equity Balance as of January 1, 2023 5,364,452 282,552,633 36,635,564 (243,460,290 ) 7,257,081 88,349,440 Loss for the period — — — (19,285,963 ) — (19,285,963 ) Exchange differences on translation of foreign currency — — — — (17,116 ) (17,116 ) Total comprehensive loss — — — (19,285,963 ) (17,116 ) (19,303,079 ) Issuance of common shares 1,687,110 54,796,819 — — — 56,483,929 Transaction costs — (3,360,626 ) — — — (3,360,626 ) Equity-settled share-based payments — — 2,239,397 — — 2,239,397 Share options exercised 14,431 222,512 — — — 236,943 Balance as of June 30, 2023 7,065,993 334,211,338 38,874,961 (262,746,253 ) 7,239,965 124,646,004 Balance as of January 1, 2022 5,304,452 280,310,744 30,591,209 (213,975,679 ) 3,050,271 105,280,996 Loss for the period — — — (13,536,654 ) — (13,536,654 ) Exchange differences on translation of foreign currency — — — — 5,718,815 5,718,815 Total comprehensive loss — — — (13,536,654 ) 5,718,815 (7,817,839 ) Equity-settled share-based payments — — 4,668,481 — — 4,668,481 Balance as of June 30, 2022 5,304,452 280,310,744 35,259,689 (227,512,333 ) 8,769,086 102,131,638 InflaRx N.V. and subsidiaries Unaudited Condensed Consolidated Statements of Cash Flows for the six months ended June 30, 2023 and 2022 For the six months ended June 30, 2023 (unaudited) 2022 (unaudited) (in €) Operating activities Loss for the period (19,285,963 ) (13,536,654 ) Adjustments for: Depreciation & amortization of property and equipment, right-of-use assets and intangible assets 293,328 300,870 Net finance income (1,165,044 ) (2,408,345 ) Share-based payment expense 2,239,397 4,668,481 Net foreign exchange differences (23,953 ) 130,347 Changes in: Financial assets from government grants (4,460,274 ) (8,260,503 ) Other assets 6,295,975 611,843 Employee benefits (411,774 ) (640,112 ) Other liabilities 60,443 (7,869 ) Liabilities from government grants received (5,407,634 ) (6,154,865 ) Trade and other payables 213,270 (661,741 ) Inventories (578,705 ) — Interest received 556,068 631,504 Interest paid (10,777 ) (32,039 ) Net cash used in operating activities (21,685,642 ) (25,359,081 ) Investing activities Purchase of intangible assets, property and equipment (24,673 ) (9,728 ) Purchase of current financial assets (83,071,163 ) (47,031,216 ) Proceeds from the maturity of financial assets 55,202,491 59,595,044 Net cash from/(used in) investing activities (27,893,346 ) 12,554,101 Financing activities Proceeds from issuance of common shares 56,483,929 — Transaction costs from issuance of common shares (3,360,626 ) — Proceeds from exercise of share options 236,943 — Repayment of lease liabilities (184,791 ) (182,014 ) Net cash from/(used in) financing activities 53,175,455 (182,014 ) Net increase/(decrease) in cash and cash equivalents 3,596,467 (12,986,995 ) Effect of exchange rate changes on cash and cash equivalents (345,862 ) 2,153,152 Cash and cash equivalents at beginning of period 16,265,355 26,249,995 Cash and cash equivalents at end of period 19,515,959 15,416,152 About InflaRx InflaRx GmbH (Germany) and InflaRx Pharmaceuticals Inc. (USA) are wholly owned subsidiaries of InflaRx N.V. (together, InflaRx). InflaRx (Nasdaq: IFRX) is a biopharmaceutical company focused on applying its proprietary anti-C5a and C5aR technologies to discover and develop and commercialize first-in-class, potent and specific inhibitors of the complement activation factor known as C5a and its receptor known as C5aR. C5a is a powerful inflammatory mediator involved in the progression of a wide variety of autoimmune and other inflammatory diseases. InflaRx’ 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 settings. 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 . The COVID-19 related work described herein is partly funded by the German Federal Government through grant number 16LW0113 (VILO-COVID). All responsibility for the content of this work lies with InflaRx. Contacts: InflaRx N.V. MC Services AG Email: IR@inflarx.de Katja Arnold, Laurie Doyle, Dr. Regina Lutz Email: inflarx@mc-services.eu Europe: +49 89-210 2280 U.S.: +1-339-832-0752 FORWARD-LOOKING STATEMENTS This press release contains forward-looking statements. All statements other than statements of historical fact are forward-looking statements, which are often indicated by terms such as “may,” “will,” “should,” “expect,” “plan,” “anticipate,” “could,” “intend,” “target,” “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, our ability to 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; the success of our future clinical trials for vilobelimab and any other product candidates and whether such clinical results will reflect results seen in previously conducted preclinical studies and clinical trials; the timing, progress and results of 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 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.

Emergency Use Authorization (EUA) granted by the U.S. Food and Drug Administration (FDA) for Gohibic (vilobelimab) for treatment of critically ill COVID-19 patients Gohibic planned to be available to patients in the U.S. within the next few weeks Phase III study with vilobelimab in pyoderma gangrenosum (PG) underway; first patient expected to be enrolled mid-2023 Cash, cash equivalents and marketable securities approximately €72.3 million as of March 31, 2023 Additional €53.5 million in aggregate proceeds subsequently raised under at-the-market (ATM) program and by an underwritten public offering of ordinary shares JENA, Germany, May 11, 2023 (GLOBE NEWSWIRE) -- InflaRx N.V. (Nasdaq: IFRX), a biopharmaceutical company developing anti-inflammatory therapeutics by targeting the complement system, announced today financial and operating results for the three months ended March 31, 2023, and provided a business update. Prof. Niels C. Riedemann, Chief Executive Officer and Founder of InflaRx, commented: “These last months have been truly transformative for InflaRx. Upon receiving the EUA for Gohibic (vilobelimab) for the treatment of critically ill patients with COVID-19 last month, we became the first company worldwide with a drug authorized for emergency use for the control of complement factor C5a. We are working diligently to enable physicians to access this treatment option in the U.S. and plan to make the product available to patients within the next few weeks. At the same time, we continue to diligently advance our development pipeline. We expect to treat the first patient in a Phase III trial with vilobelimab in pyoderma gangrenosum, a severe neutrophil-mediated skin disease, around mid-year and are also further developing our small molecule C5aR inhibitor, INF904, which is currently in Phase I testing. The EUA for Gohibic is a great recognition of our scientific approach, and we are excited to continue developing our product candidates to provide patients with other diseases driven by the complement system with new therapeutic options.” Recent Highlights andBusiness Update Gohibic (vilobelimab): EUA Granted for Treatment of Critically Ill COVID-19 Patients In April 2023, the FDA issued an 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). InflaRx has an initial supply of Gohibic (vilobelimab) available and is currently ramping up production at its third-party manufacturer to be able to further supply the U.S. as soon as possible. InflaRx expects to make the product available in the U.S. for the treatment of hospitalized patients within the next weeks. Therefore, the Company is expecting to be able to record first revenues from sales of Gohibic already in Q3 2023. InflaRx is continuing discussions with the FDA related to the submission of a Biologics License Application (BLA) for the full approval of Gohibic (vilobelimab). InflaRx has also completed encouraging meetings with the rapporteur and co-rapporteur member state teams of the European Committee for Medicinal Products for Human Use (CHMP) related to a planned Marketing Authorization Application with the European Medicines Agency (EMA). The Company will provide updates on the status of regulatory submissions in the U.S. and elsewhere once available. Vilobelimab in Pyoderma Gangrenosum (PG) In January 2023, InflaRx presented details related to the design of its planned pivotal Phase III study with vilobelimab in ulcerative PG, following compelling Phase II results for the treatment of this rare neutrophilic and inflammatory skin disease with destructive, painful cutaneous ulcers. The multi-national, randomized, double-blind, placebo-controlled trial has an adaptive design with an interim analysis that will determine the planned total patient number. The Company has submitted the clinical trial protocol to the FDA. InflaRx expects the first patient to be enrolled in this study around mid-2023. Vilobelimab in Cutaneous Squamous Cell Carcinoma (cSCC) InflaRx is conducting an open-label, multicenter Phase II study, evaluating vilobelimab in two study arms - as stand-alone therapy and in combination with pembrolizumab - in patients with programmed cell death protein 1 (PD1) or programmed cell death ligand 1 (PDL1) inhibitor resistant/refractory, locally advanced or metastatic cSCC. The main objectives of this trial are to assess the safety and antitumor activity of vilobelimab in the monotherapy arm and to assess the maximum tolerated or recommended dose of vilobelimab and the safety and antitumor activity of this drug pair in the combination arm. First data from the monotherapy arm are expected to be available in Q2 2023, and data from an interim analysis of the combination arm are expected in H1 2024. INF904 InflaRx is currently conducting a Phase I trial in healthy volunteers to assess the safety, tolerability and pharmacokinetic / pharmacodynamic properties of this new and proprietary low molecular weight C5aR inhibitor. The Company will explore the effect of INF904 on C5a-induced downstream activity and generate data in a format comparable with other published data on C5aR inhibitory molecules. Results are expected in H2 2023. In the future, InflaRx plans to develop INF904 for complement-mediated, chronic autoimmune and inflammatory diseases where oral administration is the preferred choice for patients. Post-Period Financing Activities In April 2023, the Company issued 3,235,723 ordinary shares under its ATM program, resulting in €14.4 million in net proceeds. Also in April 2023, the Company completed an underwritten public offering of an aggregate of 10,823,529 ordinary shares, which included the full exercise of an overallotment option granted to the underwriters to purchase 1,411,764 additional ordinary shares, resulting in €39.1 million in net proceeds. Aggregate proceeds from these equity offerings amounted to €53.5 million after deducting underwriting discounts. Dr. Thomas Taapken, Chief Financial Officer of InflaRx, said: “Our recent successful financing activities have put us on an even firmer footing, not only to fund our development activities and advance our pipeline, including the Phase III trial with vilobelimab in pyoderma gangrenosum, but also to invest into the required commercial, manufacturing and logistical infrastructure in the U.S. for making Gohibic available to physicians and patients in the U.S. very soon. Despite a financial market environment that continues to be challenging, we are now well funded to support operations into 2026.” Financial Highlights – Q1 2023 Research and Development Expenses Research and development expenses in Q1 2023 increased by €4.3 million to €14.7 million compared to Q1 2022. This increase was primarily attributable to the establishment of a commercial-scale manufacturing process for vilobelimab and regulatory expenses in conjunction with the EUA filing and other regulatory activities, as well as for the manufacturing of clinical trial-related material. General and Administrative Expenses General and administrative expenses decreased by €0.8 million to €3.6 million, from €4.4 million in Q1 2022. This decrease was attributable to lower expenses associated with equity-settled share-based compensation recognized in personnel expenses of €0.8 million. Other Income Other income amounted to €7.7 million, which was primarily attributable to income recognized from the grant payments received from the German federal government for the development of vilobelimab for critically ill COVID-19 patients. In 2021, InflaRx was awarded a grant from the German Ministry of Education and Research and the German Ministry of Health to support the development of vilobelimab for the treatment of COVID-19. As of March 31, 2023, the Company had received €25.6 million in grant funds and still has a maximum amount of €13.2 million available to claim through the end of the grant term in June 2023. The grant is structured as a reimbursement of 80% of certain pre-specified expenses related to the clinical development and manufacturing of vilobelimab. Net Financial Result Net financial result decreased by €1.3 million to net financial expense of €0.5 million in Q1 2023, from net financial result of €0.9 million in Q1 2022. This decrease is attributable to an aggregation of different factors, including higher interest income on investments of €0.4 million due to higher interest rates, lower foreign exchange gains, which decreased by €0.8 million, and higher foreign exchange losses of €1.0 million. Net Loss Net loss in Q1 2023, amounted to €11.1 million, compared to €14.0 million in Q1 2022. Liquidity and Capital Resources As of March 31, 2023, the Company had cash and cash equivalents and marketable securities amounting to €72.3 million. In addition, during April 2023, InflaRx raised proceeds of €53.5 million through the utilization of the Company’s established ATM program and through an underwritten public share offering after deducting underwriting discounts. The Company’s current funds on hand are expected to be sufficient to fund operations into 2026. Net Cash Used in Operating Activities Net cash used in operating activities decreased to €10.5 million in Q1 2023, from €12.9 million in Q1 2022. Additional Financial Information Additional 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, 2023, and the three months ended March 31, 2022, and 2021, as well as the consolidated financial statements as of and for the year ended December 31, 2022, in “ITEM 18. Financial Statements,” in InflaRx’s Annual Report on Form 20-F for the year ended December 31, 2022, as filed with the U.S. Securities and Exchange Commission (SEC). InflaRx N.V. and subsidiaries Unaudited Condensed Consolidated Statements of Operations and Comprehensive Loss for the three months ended March 31, 2023 and 2022 For the three months ended March 31, 2023 (unaudited) 2022 (unaudited) (in €, except for share data) Operating expenses Research and development expenses (14,731,908 ) (10,471,923 ) General and administrative expenses (3,608,554 ) (4,387,443 ) Total operating expenses (18,340,462 ) (14,859,366 ) Other income 7,746,189 1,593 Other expenses (566 ) (565 ) Operating result (10,594,839 ) (14,858,338 ) Finance income 456,036 27,962 Finance expenses (5,528 ) (24,586 ) Foreign exchange result (1,137,310 ) 727,933 Other financial result 197,808 125,000 Income taxes — — Loss for the period (11,083,833 ) (14,002,030 ) Share information Weighted average number of shares outstanding 44,771,703 44,203,763 Loss per share (basic/diluted) (0.25 ) (0.32 ) Loss for the period (11,083,833 ) (14,002,030 ) Other comprehensive income (loss) that may be reclassified to profit or loss in subsequent periods: Exchange differences on translation of foreign currency (16,785 ) 1,309,875 Total comprehensive loss (11,100,618 ) (12,692,154 ) InflaRx N.V. and subsidiaries Unaudited Condensed Consolidated Statements of Financial Position as of March 31, 2023 and December 31, 2022 March 31, 2023 (unaudited) December 31, 2022 (in €) ASSETS Non-current assets Property and equipment 306,371 328,920 Right-of-use assets 1,214,865 1,311,809 Intangible assets 114,847 138,905 Other assets 297,021 308,066 Financial assets 7,969,071 2,900,902 Total non-current assets 9,902,175 4,988,602 Current assets Current other assets 5,956,752 14,170,510 Income tax receivable 2,141,785 1,432,087 Financial assets from government grants 3,434,047 732,971 Other financial assets 62,779,179 64,810,135 Cash and cash equivalents 2,097,250 16,265,355 Total current assets 76,409,014 97,411,058 TOTAL ASSETS 86,311,189 102,399,660 EQUITY AND LIABILITIES Equity Issued capital 5,373,000 5,364,452 Share premium 282,668,032 282,552,633 Other capital reserves 37,842,612 36,635,564 Accumulated deficit (254,544,123 ) (243,460,290 ) Other components of equity 7,240,295 7,257,081 Total equity 78,579,816 88,349,440 Non-current liabilities Lease liabilities 896,331 987,307 Other liabilities 36,877 36,877 Total non-current liabilities 933,208 1,024,184 Current liabilities Trade and other payables 4,616,092 4,987,538 Liabilities from government grants received 1,175,487 6,209,266 Lease liabilities 365,457 369,376 Employee benefits 477,535 1,312,248 Other liabilities 163,594 147,608 Total current liabilities 6,798,165 13,026,036 Total liabilities 7,731,373 14,050,220 TOTAL EQUITY AND LIABILITIES 86,311,189 102,399,660 InflaRx N.V. and subsidiaries Unaudited Condensed Consolidated Statements of Changes in Shareholders’ Equity for the three months ended March 31, 2023 and 2022 (in €) Issued capital Share premium Other capital reserves Accumulated deficit Other components of equity Total equity Balance as of January 1, 2023 5,364,452 282,552,633 36,635,564 (243,460,290 ) 7,257,081 88,349,440 Loss for the period — — — (11,083,833 ) — (11,083,833 ) Exchange differences on translation 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 exercised 8,548 115,399 — — — 123,947 Balance as of March 31, 2023 5,373,000 282,668,032 37,842,612 (254,544,123 ) 7,240,295 78,579,816 Balance as of January 1, 2022 5,304,452 280,310,744 30,591,209 (213,975,679 ) 3,050,271 105,280,996 Loss for the period — — — (14,002,030 ) — (14,002,030 ) Exchange differences on translation of foreign currency — — — — 1,309,875 1,309,875 Total comprehensive loss — — — (14,002,030 ) 1,309,875 (12,692,155 ) Equity-settled share-based payments — — 2,530,775 — — 2,530,775 Balance as of March 31, 2022 5,304,452 280,310,744 33,121,984 (227,977,709 ) 4,360,146 95,119,617 InflaRx N.V. and subsidiaries Unaudited Condensed Consolidated Statements of Cash Flows for the three months ended March 31, 2023 and 2022 For the three months ended March 31, 2023 (unaudited) 2022 (unaudited) (in €) Operating activities Loss for the period (11,083,833 ) (14,002,030 ) Adjustments for: Depreciation & amortization of property and equipment, right-of-use assets and intangible assets 147,969 153,321 Net finance income 488,994 (856,308 ) Share-based payment expense 1,207,048 2,530,775 Net foreign exchange differences (106,793 ) 135,826 Changes in: Financial assets from government grants (2,701,076 ) — Other assets 7,515,105 (1,405,328 ) Employee benefits (834,713 ) (732,876 ) Other liabilities 15,986 (6,844 ) Liabilities from government grants received (5,033,779 ) — Trade and other payables (371,445 ) 928,526 Interest received 245,971 420,916 Interest paid (5,627 ) (24,641 ) Net cash used in operating activities (10,516,193 ) (12,858,662 ) Investing activities Purchase of intangible assets, property and equipment (6,046 ) (7,828 ) Purchase of current financial assets (25,120,832 ) — Proceeds from the maturity of financial assets 21,540,578 26,488,950 Net cash from/(used in) investing activities (3,586,300 ) 26,481,122 Financing activities Proceeds from exercise of share options 123,947 — Repayment of lease liabilities (93,744 ) (90,806 ) Net cash from/(used in) financing activities 30,202 (90,806 ) Net increase/(decrease) in cash and cash equivalents (14,072,291 ) 13,531,653 Effect of exchange rate changes on cash and cash equivalents (95,814 ) 314,639 Cash and cash equivalents at beginning of period 16,265,355 26,249,995 Cash and cash equivalents at end of period 2,097,250 40,096,286 About InflaRx InflaRx GmbH (Germany) and InflaRx Pharmaceuticals Inc. (USA) are wholly owned subsidiaries of InflaRx N.V. (together, InflaRx). InflaRx (Nasdaq: IFRX) is a biopharmaceutical company focused on applying its proprietary anti-C5a / C5aR technologies to discover and develop first-in-class or best-in-class, potent and specific inhibitors of C5a and C5aR. Complement C5a and its receptor C5aR are powerful inflammatory mediators involved in the progression of a wide variety of autoimmune and other inflammatory diseases. 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 . The COVID-19 related work described herein is partly funded by the German Federal Government through grant number 16LW0113 (VILO-COVID). All responsibility for the content of this work lies with InflaRx. Contacts: InflaRx N.V. Email: IR@inflarx.de MC Services AG Katja Arnold, Laurie Doyle, Regina Lutz Email: inflarx@mc-services.eu Europe: +49 89-210 2280 U.S.: +1-339-832-0752 FORWARD-LOOKING STATEMENTS This press release contains forward-looking statements. All statements other than statements of historical fact are forward-looking statements, which are often indicated by terms such as “may,” “will,” “should,” “expect,” “plan,” “anticipate,” “could,” “intend,” “target,” “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, our ability to commercialize Gohibic (vilobelimab) or our other product candidates; our expectations regarding the size of the patient populations for, market opportunity for, coverage and reimbursement for and clinical utility of Gohibic (vilobelimab) in its approved or authorized indication or for vilobelimab and any other product candidates, under EUA and in the future if approved for commercial use in the U.S. or elsewhere; the success of our future clinical trials for vilobelimab and any other product candidates and whether such clinical results will reflect results seen in previously conducted preclinical studies and clinical trials; the timing, progress and results of 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 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 InflaRx’s 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.