- InflaRx will focus development activities and resources initially on selected indications in immuno-dermatology, with registrational-phase vilobelimab and potentially best-in-class oral C5aR inhibitor INF904
- INF904 development will be initially targeted at chronic spontaneous urticaria (CSU) and hidradenitis suppurativa (HS), with initiation of a Phase IIa PK dose-ranging study expected by the end of 2024, with data availability anticipated in 2025
- InflaRx is considering partnership options for INF904 in additional areas of interest with a goal of unlocking its “pipeline-in-a-product" potential more broadly
- Ongoing Phase III trial with vilobelimab in pyoderma gangrenosum (PG) is expected to have an interim analysis in 2025
- Cash, cash equivalents and marketable securities of €98.4 million expected to fund operations at least into 2026
- Company management to provide a pipeline update including details on the chosen INF904 development indications today,
March 21, 2024 , at8:00 am ET
JENA,
Prof.
Prof. Dr.
Pipeline update event today; R&D day to follow later this year
InflaRx will host a virtual pipeline update call today, beginning at
To participate in the conference call, participants may pre-register here and will receive a dedicated link and dial-in details to easily and quickly access the call. An accompanying updated corporate deck can be found here.
InflaRx is also planning a virtual research and development event to follow later this year to provide more details on its development plans and to offer insights from key opinion leaders into the development and commercial rationales of InflaRx’s pipeline.
Immuno-dermatology pipeline focus: INF904 for CSU and HS
InflaRx has chosen two initial immuno-dermatology indications that it intends to pursue with INF904 via the initiation of a Phase IIa “basket study”. These indications initially include CSU and HS, 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, with INF904 being 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 to improve standard of care for patients with these conditions. InflaRx estimates significant market potential for INF904 in these two indications, both estimated as multi-billion-dollar markets.
InflaRx is currently conducting additional pre-clinical studies, including chronic toxicology studies, to enable longer-term dosing of INF904. Consistent with previous communications, InflaRx anticipates initiating a Phase IIa study with INF904 before the end of 2024. This open-label Phase IIa study is expected to explore at least three different doses of INF904 for a duration of 4 weeks and to assess pharmacokinetic (PK) and pharmacodynamic (PD) parameters in patients, as well as provide safety data and certain early efficacy readouts. Data from this Phase IIa study is expected to be released in 2025. InflaRx expects to initiate a larger and longer-term Phase IIb study in 2025 as well.
INF904 for CSU
CSU is a debilitating and unpredictable skin disease characterized by intensely itchy hives / wheals and angioedema. The burden of this chronic disease is high and impacts sleep, mental health, quality of life and productivity due to absences from school and work. CSU is estimated to affect around 40 million people worldwide.
CSU patients have been reported to show elevated C5a levels, a major activator of mast cells and basophils, which are thought to be significant contributors to CSU pathogenesis. In addition, studies suggest that complement activation (including C5a) in CSU can lead to histamine release.
Current treatments are limited, and a significant unmet need exists in a sizable proportion of patients. As an orally available agent with a favorable PK / PD profile that could drive a broad dose range for systemic exposure, INF904 could find a differentiated position in the CSU market.
INF904 for HS
HS is a chronic, recurrent, debilitating neutrophil-driven inflammatory disease that can persist for years and tremendously impacts quality of life; it is characterized by abscesses, nodules and draining tunnels which can flare and cause scarring.
INF904 inhibits the known C5a-induced effects on neutrophil activation and tissue accumulation of immune cells, including generation of tissue damaging mechanisms (enzyme release and oxidative radical formation) as well as induction of NETosis – mechanisms thought to be involved in HS progression and draining tunnel formation. Clinical evidence with existing C5a/C5aR products also supports that blocking this pathway reduces lesion counts.
Patients’ responses to treatment with approved anti-TNF-alpha or anti-IL17 drugs are known to wane over time in a significant number of cases, and treatments with new mechanisms are needed for these patients. As an orally available agent with a favorable PK / PD profile that could drive a broad dose range for systemic exposure, INF904 could find a differentiated and commercially advantageous place in HS treatment.
INF904 as a “pipeline-in-a-product"
Given the potential of INF904 to have a broad commercial footprint, InflaRx believes it could address meaningful markets in immuno-dermatology and in immuno-inflammation, including in neurology, nephrology and hematology. While InflaRx intends to focus its resources on its immediate goals with CSU and HS, it also assesses pursuit of these additional areas via potential future collaborations with partners.
Immuno-dermatology pipeline focus: Vilobelimab for PG
InflaRx’s strategy and planning for vilobelimab in PG remain unchanged and its development is currently on track. InflaRx is conducting a multi-national, randomized, double-blind, placebo-controlled pivotal Phase III study with 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 study 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, the trial sample size will be adapted, or the trial will be terminated due to futility. The 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
Select 2023 and recent operational highlights
INF904 - Positive topline results from Phase I trial support best-in-class potential
In
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 (SAD) and the MAD part of the study showed very 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.
New executives further strengthen the InflaRx team
In
In
Financing activities
In
Vilobelimab for the treatment of critically Ill COVID-19 Patients
In
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
InflaRx received a total of €33.3 million to support its COVID-19 clinical development as part of a grant awarded by the German federal government for the period of
Dr.
2023 Financial Highlights
Revenue
In 2023, for the first time since its inception, InflaRx realized revenues from its product sales. Revenues reported are sales to end customers (hospitals). Sales to distributors do not constitute completion of a performance obligation towards a customer and, thus, do not result in the recognition of revenue for InflaRx under IFRS 15. The company is continuing its cost-disciplined launch efforts to educate health care providers and implement measures to make the drug available for eligible patients.
Cost of sales
Cost of sales recognized during the twelve months ended
Costs of sales for products sold in these periods do not include costs of materials, as the associated costs of these materials were incurred in prior periods, before the FDA granted an EUA for GOHIBIC (vilobelimab) in
The cost of sales during the twelve months ended
Sales and marketing expenses
During the twelve months ended
Research and development expenses
InflaRx’s research and development expenses increased by €3.5 million for the year ended
General and administrative expenses
InflaRx’s general and administrative expenses decreased by €2.2 million to €12.6 million for the year ended
Other income
In 2023, InflaRx recognized other income of €13.2 million, which is primarily attributable to income recognized from grant payments received from the German federal government for the development of vilobelimab in severe COVID-19 patients, including expenses related to clinical development and manufacturing process development. Other income decreased in 2023, compared to the prior year, due to the incurrence of less expenses eligible for reimbursement under the grant and the end of the grant period on
Net financial result
InflaRx’s net financial result decreased by €0.5 million to €2.2 million for the year ended
Net loss
InflaRx incurred a net loss of €42.7 million, or €0.78 per common share, in 2023 compared to €29.5 million, or €0.67 per common share, in 2022.
Liquidity and capital resources
As of
Net cash used in operating activities
InflaRx’s net cash used in operating activities increased to €37.8 million in the year ended
Additional financial information
Additional information regarding these results and other relevant information is included in the notes to the financial statements in “Item 18. Financial Statements,” which are included in InflaRx’s most recent annual report on Form 20-F as filed today with the
Consolidated statements of operations and comprehensive loss for the years ended
2023 | 2022 | 2021 | ||||||
(in €, except for share data) | ||||||||
Revenues | 63,089 | — | — | |||||
Cost of sales | (532,262 | ) | — | — | ||||
Gross profit | (469,173 | ) | — | — | ||||
Sales and marketing expenses | (4,001,299 | ) | — | — | ||||
Research and development expenses | (41,024,131 | ) | (37,526,090 | ) | (35,697,935 | ) | ||
General and administrative expenses | (12,628,756 | ) | (14,869,564 | ) | (11,984,722 | ) | ||
Other income | 13,219,704 | 20,159,169 | 54,221 | |||||
Other expenses | (4,440 | ) | (1,381 | ) | (6,381 | ) | ||
Operating result | (44,908,096 | ) | (32,237,866 | ) | (47,634,817 | ) | ||
Finance income | 3,804,827 | 608,679 | 109,391 | |||||
Finance expenses | (35,628 | ) | (45,250 | ) | (24,769 | ) | ||
Foreign exchange result | (1,841,872 | ) | 2,442,297 | 1,964,135 | ||||
Other financial result | 313,240 | (252,471 | ) | (44,000 | ) | |||
Income taxes | — | — | — | |||||
Loss for the period | (42,667,529 | ) | (29,484,611 | ) | (45,630,059 | ) | ||
Other comprehensive income (loss) that may be reclassified to profit or loss in subsequent periods: | ||||||||
Exchange differences on translation of foreign currency | 125,085 | 4,206,810 | 6,777,061 | |||||
TOTAL COMPREHENSIVE LOSS | (42,542,444 | ) | (25,277,801 | ) | (38,852,998 | ) | ||
Share information (based on loss for the period) | ||||||||
Weighted average number of shares outstanding | 54,940,137 | 44,207,873 | 41,629,974 | |||||
Loss per share (basic/diluted) | (0.78 | ) | (0.67 | ) | (1.10 | ) | ||
LOSS FOR THE PERIOD | (42,667,529 | ) | (29,484,611 | ) | (45,630,059 | ) |
Consolidated statements of financial position as of
ASSETS | (in €) | ||||
Non-current assets | |||||
Property and equipment | 289,577 | 328,920 | |||
Right-of-use assets | 1,071,666 | 1,311,809 | |||
Intangible assets | 68,818 | 138,905 | |||
Other assets | 257,267 | 308,066 | |||
Financial assets | 9,052,741 | 2,900,902 | |||
Total non-current assets | 10,740,069 | 4,988,602 | |||
Current assets | |||||
Inventories | 11,367,807 | — | |||
Current other assets | 4,036,650 | 14,170,510 | |||
Tax receivable | 3,791,564 | 1,432,087 | |||
Financial assets from government grants | — | 732,971 | |||
Other financial assets | 77,504,518 | 64,810,135 | |||
Cash and cash equivalents | 12,767,943 | 16,265,355 | |||
Total current assets | 109,468,483 | 97,411,058 | |||
TOTAL ASSETS | 120,208,552 | 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 | 40,050,053 | 36,635,564 | |||
Accumulated deficit | (286,127,819 | ) | (243,460,290 | ) | |
Other components of equity | 7,382,166 | 7,257,081 | |||
Total equity | 102,581,730 | 88,349,440 | |||
Non-current liabilities | |||||
Lease liabilities | 745,716 | 987,307 | |||
Other liabilities | 36,877 | 36,877 | |||
Total non-current liabilities | 782,593 | 1,024,184 | |||
Current liabilities | |||||
Trade and other payables | 11,974,362 | 4,987,538 | |||
Liabilities from government grants | — | 6,209,266 | |||
Lease liabilities | 374,329 | 369,376 | |||
Employee benefits | 1,609,766 | 1,312,248 | |||
Other liabilities | 2,885,772 | 147,608 | |||
Total current liabilities | 16,844,229 | 13,026,036 | |||
Total liabilities | 17,626,822 | 14,050,220 | |||
TOTAL EQUITY AND LIABILITIES | 120,208,552 | 102,399,660 | |||
Consolidated statements of changes in shareholders’ equity for the years ended
in € | Issued capital | Share premium | Other capital reserves | Accumulated deficit | Other components of equity | Total equity | |||||||||||
Balance as of | 3,387,410 | 220,289,876 | 26,259,004 | (168,345,620 | ) | (3,726,791 | ) | 77,863,880 | |||||||||
Loss for the Period | — | — | — | (45,630,059 | ) | — | (45,630,059 | ) | |||||||||
Exchange differences on translation of foreign currency | — | — | — | — | 6,777,061 | 6,777,061 | |||||||||||
Total Comprehensive Loss | — | — | — | (45,630,059 | ) | 6,777,061 | (38,852,998 | ) | |||||||||
Issuance of common shares | 1,873,203 | 63,269,346 | — | — | — | 65,142,549 | |||||||||||
Transaction costs | — | (4,219,222 | ) | — | — | — | (4,219,222 | ) | |||||||||
Equity-settled share-based payments | — | — | 4,332,205 | — | — | 4,332,205 | |||||||||||
Share options exercised | 43,839 | 970,744 | — | — | — | 1,014,583 | |||||||||||
Balance as of | 5,304,452 | 280,310,744 | 30,591,209 | (213,975,679 | ) | 3,050,270 | 105,280,996 | ||||||||||
Loss for the Period | — | — | — | (29,484,611 | ) | — | (29,484,611 | ) | |||||||||
Exchange differences on translation of foreign currency | — | — | — | — | 4,206,810 | 4,206,810 | |||||||||||
Total Comprehensive Loss | — | — | — | (29,484,611 | ) | 4,206,810 | (25,277,801 | ) | |||||||||
Issuance of common shares | 60,000 | 2,289,624 | — | — | — | 2,349,624 | |||||||||||
Transaction costs | — | (47,735 | ) | — | — | — | (47,735 | ) | |||||||||
Equity-settled share-based payments | — | — | 6,044,356 | — | — | 6,044,356 | |||||||||||
Balance as of | 5,364,452 | 282,552,633 | 36,635,564 | (243,460,290 | ) | 7,257,080 | 88,349,440 | ||||||||||
Loss for the Period | — | — | — | (42,667,529 | ) | — | (42,667,529 | ) | |||||||||
Exchange differences on translation of foreign currency | — | — | — | — | 125,085 | 125,085 | |||||||||||
Total Comprehensive Loss | — | — | — | (42,667,529 | ) | 125,085 | (42,542,444 | ) | |||||||||
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 | — | — | 3,414,489 | — | — | 3,414,489 | |||||||||||
Share options exercised | 14,431 | 222,512 | — | — | — | 236,943 | |||||||||||
Balance as of | 7,065,993 | 334,211,338 | 40,050,053 | (286,127,819 | ) | 7,382,166 | 102,581,730 | ||||||||||
Consolidated statements of cash flows for the years ended
2023 | 2022 | 2021 | ||||||
(in €) | ||||||||
Operating activities | ||||||||
Loss for the period | (42,667,529 | ) | (29,484,611 | ) | (45,630,059 | ) | ||
Adjustments for: | ||||||||
Depreciation & amortization of property and equipment, right-of-use assets and intangible assets | 567,780 | 596,597 | 669,434 | |||||
Net finance income | (2,240,566 | ) | (2,753,255 | ) | (2,004,757 | ) | ||
Share-based payment expense | 3,414,489 | 6,044,356 | 4,332,205 | |||||
Net foreign exchange differences | 413,017 | 385,359 | 111,606 | |||||
Changes in: | ||||||||
Financial assets from government grants | 732,971 | (732,971 | ) | — | ||||
Other assets | 7,825,182 | (3,308,485 | ) | (7,094,467 | ) | |||
Employee benefits | 297,518 | (64,024 | ) | (3,290 | ) | |||
Other liabilities | 2,738,164 | 9,403 | 19,863 | |||||
Liabilities from government grants received | (6,209,266 | ) | (2,090,734 | ) | 8,300,000 | |||
Trade and other payables | 6,986,824 | (3,586,706 | ) | 316,112 | ||||
Inventories | (11,367,807 | ) | — | — | ||||
Interest received | 1,732,284 | 1,287,200 | 1,070,235 | |||||
Interest paid | (36,025 | ) | (44,946 | ) | (23,633 | ) | ||
Net cash used in operating activities | (37,812,966 | ) | (33,742,817 | ) | (39,936,751 | ) | ||
Investing activities | ||||||||
Purchase of intangible assets and property and equipment | (81,100 | ) | (162,391 | ) | (37,778 | ) | ||
Purchase of current and non-current financial assets | (104,051,972 | ) | (64,474,543 | ) | (97,516,417 | ) | ||
Proceeds from the maturity of current financial assets | 86,436,456 | 83,995,029 | 71,603,310 | |||||
Net cash from/ (used in) investing activities | (17,696,616 | ) | 19,358,095 | (25,950,885 | ) | |||
Financing activities | ||||||||
Proceeds from issuance of ordinary shares | 56,483,929 | 2,349,624 | 65,142,549 | |||||
Transaction costs from issuance of ordinary shares | (3,360,626 | ) | (47,735 | ) | (4,219,222 | ) | ||
Proceeds from exercise of share options | 236,943 | — | 1,014,583 | |||||
Repayment of lease liabilities | (373,977 | ) | (364,430 | ) | (360,644 | ) | ||
Net cash from financing activities | 52,986,269 | 1,937,459 | 61,577,266 | |||||
Net decrease in cash and cash equivalents | (2,523,313 | ) | (12,447,262 | ) | (4,310,369 | ) | ||
Effect of exchange rate changes on cash and cash equivalents | (974,099 | ) | 2,462,622 | 4,591,683 | ||||
Cash and cash equivalents at beginning of period | 16,265,355 | 26,249,995 | 25,968,681 | |||||
Cash and cash equivalents at end of period | 12,767,943 | 16,265,355 | 26,249,995 | |||||
About
InflaRx (Nasdaq: IFRX) is a biotechnology 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 C5a-induced signaling via the C5a receptor. InflaRx was founded in 2007, and the group has offices and subsidiaries in Jena and
Contacts:
Vice President, Head of Investor Relations Email: IR@inflarx.de | Email: inflarx@mc-services.eu |
* Eligibility Requirements, Terms and Conditions apply. Please see the full Terms and Conditions provided on the webpage: The InflaRx Commitment Program.
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, the receptiveness of GOHIBIC (vilobelimab) as a treatment for COVID-19 by COVID-19 patients and
Source:
2024 GlobeNewswire, Inc., source