Full Press Release Details
InflaRx Reports Full Year 2022
Financial and Operating Results
Jena, Germany, March 22, 2023 - InflaRx
N.V. (Nasdaq: IFRX), a clinical-stage biopharmaceutical company developing anti-inflammatory therapeutics by targeting the complement
system, today announced financial and operating results for the year ended December 31, 2022.
Prof. Niels C. Riedemann, CEO and Founder of InflaRx,
commented: "We are very pleased with the exceptional progress we have made in the past year with our lead drug candidate, vilobelimab,
in several areas, as well as in advancing our pipeline with a new clinical asset, INF904, an orally available small molecule inhibitor
of the C5a receptor. Upon detailed feedback from the FDA related to our development of vilobelimab for the treatment of PG, a rare debilitating
and neutrophil driven skin disease, we have designed and submitted a Phase III protocol to the FDA while we are currently initiating the
trial. We also submitted an EUA application to treat critically ill, mechanically ventilated patients with COVID-19, who today are still
facing poor outcomes, and shortly await a decision from the FDA. Further, we expect first results from our ongoing Phase I clinical trial
with INF904 and interim results from our Phase II clinical trial in cutaneous squamous cell carcinoma later this year. With these important
milestones anticipated, 2023 promises to be an exciting year."
Recent Highlights and R&D Update
InflaRx reported on key recent highlights and
provided an update on its research and development activities.
Vilobelimab in Pyoderma Gangrenosum (PG)
Final data from an open-label, multi-center Phase
IIa exploratory study evaluating the safety and efficacy of vilobelimab in patients with moderate to severe PG were presented in March
2022. The results showed a dose-dependent treatment effect. In the highest dose cohort of 2,400 mg, six out of seven patients demonstrated
a clinical remission (Physician Global Assessment (PGA) score 1) and closure of the target ulcer.
Based on these compelling results and a productive
End-of-Phase II meeting with the FDA in Q3 2022, InflaRx is moving forward with a pivotal Phase III clinical development program in this
indication. In January 2023, the Company announced details related to the design of its planned Phase III study, a multi-national, randomized,
double-blind, placebo-controlled trial. The Company has submitted the clinical trial protocol to the FDA and plans to begin patient enrollment
Vilobelimab was granted Orphan Drug designation
by both the FDA and the European Medicines Agency (EMA) for the treatment of ulcerative PG in June 2022, and in July was granted Fast
Track designation for this indication by the FDA.
Vilobelimab for the Treatment of Critically
ill COVID-19 Patients
InflaRx submitted an EUA application to the FDA
for vilobelimab for the treatment of critically ill, intubated, mechanically ventilated COVID-19 patients in September 2022. The Company
continues to be in active dialogue with and has addressed several requests for information that it received from the FDA. There is no
set timeline for a decision from the FDA related to the EUA. The Company will continue to interact closely with the FDA and will provide
a timely update when appropriate. If EUA is granted, InflaRx plans to seek full marketing authorization in major markets, including the
United States and Europe and, in parallel, intends to seek partners to support commercialization efforts.
InflaRx also previously received Fast Track designation
from the FDA for vilobelimab for the treatment of critically ill, intubated, mechanically ventilated COVID-19 patients.
In September 2022, results from the PANAMO Phase
III study, an international, double-blind, placebo-controlled, randomized clinical trial investigating vilobelimab in invasively mechanically
ventilated COVID-19 patients, were published in the peer-reviewed journal, The Lancet Respiratory Medicine, which included an in-depth
statistical analysis supporting the robustness of the observed clinical survival benefit in the study.
Based on current COVID-19 trends, the U.S. Department of Health and
Human Services (HHS) expects the COVID-19 federal public health emergency to expire on May 11, 2023. However, HHS has stated that it expects
that the FDA will provide continued access to pathways for EUAs for medical products. See https://www.fda.gov/emergency-preparedness-and-response/mcm-legal-regulatory-and-policy-framework/faqs-what-happens-euas-when-public-health-emergency-ends.
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 December 31, 2022, the Company had received 25.6 million in grant funds and still has a maximum amount of 15.9 million
available for claiming under the grant throughout the end of the grant term in June 2023.
Vilobelimab in Cutaneous Squamous Cell
InflaRx is conducting an open-label, multicenter
Phase II study, evaluating vilobelimab alone and in combination with pembrolizumab in patients with programmed cell death protein-1 (PD-1)
or programmed cell death ligand-1 (PD-L1) inhibitor resistant/refractory, locally advanced or metastatic cSCC. Patients are being recruited
into two independent arms - vilobelimab as monotherapy (Arm A) and in combination with pembrolizumab (Arm B). The main objectives of the
trial are to assess the safety and antitumor activity of vilobelimab monotherapy and to determine the maximum tolerated or recommended
dose, safety and antitumor activity in the combination arm in this patient population.
So far, 10 patients have been recruited into Arm
A of the study. First data from an interim analysis in patients in Arm A is expected to be available in the first half of 2023. In Arm
B of the study, as of today, 14 patients have been recruited into three dose cohorts (3+6+5). Data from an interim analysis in Arm B are
expected to be available in the first half of 2024.
C5aR Inhibitor INF904
In November 2022, the company announced that the
first healthy volunteer had been dosed in a randomized, double-blind, placebo-controlled Phase I trial. This single and multiple ascending
dose Phase I trial aims to evaluate the safety, tolerability and pharmacokinetics of INF904 in healthy volunteers. The effect of INF904
on C5a-induced downstream activity will also be explored. Results are expected in the second half of 2023. In the future, InflaRx plans
to develop INF904 for complement-mediated, chronic autoimmune and inflammatory diseases where oral administration is the preferred choice
In December 2022, InflaRx amended its existing
co-development agreement with Staidson (Beijing) BioPharmaceuticals Co., Ltd. (Staidson) from 2015 to support Staidson in its regulatory
approval efforts for its proprietary drug candidate BDB-001 in China. InflaRx will receive royalties of 10% on net sales of BDB-001 for
the treatment of COVID-19 in China. InflaRx has granted Staidson an exclusive license for use in China to certain of InflaRx's clinical,
manufacturing and regulatory documentation regarding vilobelimab in order to support and facilitate the planned regulatory filing for
BDB-001 for the treatment of severely ill COVID-19 patients with the Chinese National Medical Products Administration (NMPA).
In parallel, InflaRx entered into a share purchase
agreement with Staidson Hong Kong Investment Company Limited (Staidson HK), an affiliate of Staidson, pursuant to which Staidson HK purchased
ordinary shares of InflaRx for an aggregate amount of $2.5 million at a price of $5.00 per share. The share purchase agreement also includes
an option pursuant to which Staidson HK may in the future purchase, at InflaRx's discretion, additional ordinary shares for an aggregate
amount of $7.5 million.
2022 Financial Highlights
Dr. Thomas Taapken, CFO of InflaRx, said: "We
are well financed to bring vilobelimab to patients, should we receive EUA, as well as to continue our development programs, including
initiating a Phase III study in PG later this year. The grant money we have received from the German government for our COVID-19 development
work as well as the investment by Staidson further strengthen our financial position, and we have sufficient cash to fund operations into
Research and Development (R&D) Expenses
InflaRx's R&D expenses increased by
1.8 million to 37.5 million in 2022, from 35.7 million in 2021. R&D expenses are predominantly comprised of costs
for external contract research organizations (CROs) for pre-clinical activities and the conduct of clinical trials, costs for external
contract manufacturing organizations (CMOs) for product manufacturing-related activities, costs for professional consultants primarily
in the areas of regulatory affairs and intellectual property, as well as personnel expenses.
General and Administrative (G&A) Expenses
InflaRx's G&A expenses increased by
2.9 million to 14.9 million in 2022, from 12.0 million in 2021. The increase is partly attributable to higher consulting
and legal costs incurred in enhancing InflaRx's internal control environment as it is complying with the auditor attestation requirement
of Section 404(b) of the Sarbanes-Oxley Act of 2002 for the first time due to the loss of its "emerging growth company" status.
G&A expenses are predominantly comprised of professional fees for auditors, consulting expenses not related to R&D activities,
professional fees for lawyers, cost of facilities, travel, communication and office expenses as well as personnel related expenses.
In 2022, InflaRx recognized other income of 20.1
million from grant payments received from the German federal government for the development of vilobelimab in COVID-19, including expenses
related to clinical development and manufacturing process development.
Net Financial Result