Full Press Release Details
CORPORATE PRESENTATION MARCH 2024
Important Notice and Disclaimer This presentation has been prepared by InflaRx
N.V. ("InflaRx" or the "Company"). This presentation is made for informational purposes only and does not constitute an offer to sell or a solicitation of an offer to buy securities. This presentation may not be relied upon in connection with
the purchase or sale of any security and should not be construed as investment advice. 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 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 U.S. 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 biologics license application 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.
Important Notice and Disclaimer Information and Sources Certain information
contained in this presentation relates to or is based on studies, publications, surveys and other data obtained from third-party sources and InflaRx's own internal estimates and research. While InflaRx believes these third-party sources to be
reliable as of the date of this presentation, it has not independently verified, and makes no representation as to the adequacy, fairness, accuracy or completeness of, any information obtained from third-party sources. In addition, all of the
market data included in this presentation involves a number of assumptions and limitations, and there can be no guarantee as to the accuracy or reliability of such assumptions. Further, while we believe our own internal research is reliable,
such research has not been verified by any independent source. Avacopan Data We have not conducted a head-to-head comparison of Avacopan to INF904 in a clinical trial but have compared the published data for Avacopan to data from our Phase 1
clinical trial of INF904. For the purpose of conducting pre-clinical studies (hamster neutropenia study), we synthesized Avacopan and did a side-by-side comparison. While we believe this comparison to Avacopan to be useful and appropriate, the
value of this and other comparisons to Avacopan in this presentation may be limited because they are not derived from a head-to-head trial and they are from trials that were conducted under different protocols at different sites and at
different times. Without head-to-head data, we are unable to make comparative claims between INF904 and Avacopan. 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 biotechnology company pioneering anti-inflammatory therapeutics by applying its proprietary anti-C5a and anti-C5aR technologies to discover, develop and commercialize first-in-class, 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 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.
Harnessing C5a/C5aR for Controlling Inflammation in the I&I Space InflaRx
Highlights Uniquely targeting complement C5a/C5aR, a validated mechanism and critical part of the inflammation cascade with: First-in-class and highly potent anti-C5a monoclonal antibody (vilobelimab + second generation IFX-2) Best-in-class
potential oral C5aR inhibitor INF904: Addressing limitations of marketed comparator (clearly differentiated plasma PK profile and inhibitory potential in phase I study) Pipeline-in-a-drug with potential to address several large markets in
immuno-dermatology and broader I&I A targeted development focus on immuno-dermatology where InflaRx can drive pipeline value in larger markets and has strong core IP and medical use IP coverage Vilobelimab in late-stage development for PG
an unmet need with no approved drug in the US or Europe INF904 to initially demonstrate pipeline-in-a-drug potential in large markets of CSU and HS; expected to start Phase II development in 2024 Large upside potential in additional
indications in I&I for proprietary drugs with options for collaborations Strong balance sheet with enough cash to fund operations into at least 2026 and advance programs toward next milestones Team with proven track record of delivering
clinical and regulatory successes CSU [chronic spontaneous urticaria. HS [hidradenitis suppurativa]. PG [pyoderma gangrenosum]. I&I [inflammation and immunology]. Page 4
Significant Opportunity in Immuno-Dermatology Page 5 Potential to target several
attractive, billion-dollar+ commercial markets InflaRx has identified unmet medical needs that INF904 could strongly address Strong rationale for the role of C5a/C5aR based on mechanism of action, pre-clinical and clinical data Established
endpoints with the ability of INF904 to potentially achieve a clinical edge and prove to be a differentiated competitor INF904 is an oral drug with no known safety concerns and potential broad therapeutic index As a C5aR antagonist, INF904
acts on a differentiated pathway with a MoA not currently addressed by any other treatment approaches in the immuno-dermatology field Established network of experts and in-house trial expertise Strong IP coverage for C5aR inhibition in
certain immuno-dermatological diseases Why Immuno-Dermatology
Key initial development focus and area to demonstrate potential of
INF904 Potential for future development or development in collaboration with a partner Immuno-dermatology Neurology Nephrology & Hematology Chronic spontaneous urticaria (CSU) Hidradenitis suppurativa (HS) others Chronic
inflammatory demyelinating polyneuropathy (CIDP) Dermatomyositis Anti-C3 glomerulopathy (C3G) Atypical haemolytic uraemia syndrome (aHUS) Immunoglobulin A nephropathy (IgAN) ANCA-associated vasculitis (AAV) Page 6 Focus INF904 on
Immuno-Dermatology: I&I Pipeline-in-a-Drug Potential
Page 7 Late-Stage Pipeline Targets Multiple Sizable Markets vilobelimab C5a
Inhibitor IFX002 C5a Inhibitor INF904 Oral C5aR Inhibitor IMMUNO-DERMATOLOGY vilobelimab C5a Inhibitor OTHER INF904 Oral C5aR Inhibitor chronic spontaneous urticaria Phase IIa "basket study" anticipated by YE 2024 Data
anticipated in 2025 Indications PreClin Phase I Phase II Phase III MARKET STATUS & Milestones pyoderma gangrenosum Enrollment ongoing Interim analysis for adaptation and futility anticipated in 2025 critical COVID-19 broader
ARDS US EUA granted; EU MAA under review ARDS "Phase III ready" hidradenitis suppurativa Phase IIa "basket study" anticipated by YE 2024 Data anticipated in 2025 other immuno-dermatology Additional indications in
immuno-dermatology vilobelimab life-cycle approach For optimized use in chronic inflammatory indications various Additional chronic indications in I&I including neurology, nephrology and hematology and others
Vilobelimab [C5a monoclonal antibody] INF904 [oral C5aR inhibitor] C5a/C5aR: A
Strategic Position in the Inflammatory Cascade
Anaphylatoxin C5a is upstream of the cytokine network Boosting effect on various
pro-inflammatory cytokines IL-17, IL-6, IL-8, IL-1 and others Strong activator of neutrophils and macrophages Chemotaxis of neutrophils O2 radical generation + granular enzyme release NETosis (neutrophil extracellular traps) Essential
role in many inflammatory conditions Acute and chronic inflammation and other conditions Over 6,000 publications on role in numerous diseases C5a/C5aR are Validated Targets Promoting Inflammation Page 9 C5a strong amplifierof
inflammation C5aR expressed on many immune cells and upregulated in many tissues under disease conditions Targeting strong pro-inflammatory mechanisms vilobelimab intravenous mAB INF904 oral small molecule Targeting C5 (e.g. marketed C5
blockers) does not prevent enzymatic C5a formation, but only complement pathway mediated cleavage (classic, lectin, alternative) not suitable for tightly controlling C5a/C5aR1-driven inflammation C5
Vilobelimab for Ulcerative Pyoderma Gangrenosum (PG)
Highly selective anti-C5a mAB Blocks C5a biological effects up to 100% in human
blood Leaves MAC formation intact Fast binding / high affinity to the newly discovered epitope Commercially validated / available under Emergency Use Authorization in certain severely ill COVID-19 patients Vilobelimab: A First-in-Class
Anti-C5a Monoclonal Antibody Page 11 new epitope Vilobelimab Key Features Development Areas in Acute and Sub-Acute Inflammation As a fast acting highly specific monoclonal antibody infused, vilobelimab delivers: Strong and immediate C5a
inhibition in blood Fast onset of inhibition of neutrophil activation in human blood Potential disease modifying activity for diseases in which C5a signaling may play a key role
PG: An Autoimmune Condition With High Unmet Need Page 12 PG Overview and Unmet
Need Clinical features PG is a rare but potentially life-threatening skin disorder that can lead to chronic, difficult-to-treat wounds Patients frequently suffer from other autoimmune disorders, e.g. ulcerative colitis, rheumatoid arthritis
and hematological diseases Patients suffer from severe pain, long healing times and frequent relapses Incidence and market potential Rare - estimated that up to 50,000 patients in the US and Europe are affected Significant market potential
- premium pricing expected based on performed market study Current treatment and medical need No drugs currently approved in the US or EU For less severe cases, topical or intralesional treatments can be used, including topical steroids Use
of systemic immunosuppression in rapidly progressing cases Mixed reports about efficacy; long treatment durations and relapses are frequently seen Strong rationale for treatment with vilobelimab: PG associated with neutrophilic skin
infiltration in affected areas and lesions, potentially triggered by C5a
C5a Levels in PG Wound Fluid Correlate With NETosis The etiology of PG is
believed to be linked to the dysregulation of the immune system, specifically, altered neutrophil function Evidence suggest that complement activation and C5a play an important role in the disease development: High C5a levels were detected in
the wound fluids from PG patients C5a levels correlated well with elastase levels in wound fluids, a NETosis marker C5a/C5aR axis activation may be a key driver for NETosis in PG C5a Induces NETosis in Control Neutrophils
PG Pathogenesis: Potential Role of the C5a/C5aR Axis Page 13 Con C5a (20 nM; 1hr) Extracellular DNA Staining Wang et al 2024. J invest Derm. 144; TW = Trauma Wound
PG Phase IIa Showed No Safety or Tolerability Concerns and Dose-Dependent Drug
Activity Page 14 Clinical Response High-dose group showed highest rate of target ulcer closure and clinical remission (86%) Out of 17 evaluable patients at end of treatment visit or day of last drug administration Clinical remission (PGA
1) reported in 9 patients (53%) Clinical response (PGA 3) reported in 1 additional patient (6%) Slight improvement (PGA = 4) reported in 7 patients (41%) Safety No infusion-related reactions observed For 2 patients, related SAEs were
reported Erysipelas leading to hospitalization (judged as non-related by sponsor) Rash due to delayed hypersensitivity reaction Observed AE profile in line with patients' underlying diseases No dose-related AEs detected Phase III
Initiated Based on Feedback From FDA Orphan Drug and Fast Track Status US FDA Orphan Drug Status EMA
PG Study Phase IIa - Treatment Examples Patient Case Studies Page 15 Target
Ulcer Developed While on Adalimumab MH: PG since August 2020, Psoriasis since 2017 Previous PG medication: None Cohort 3: 2400 mg Q2W up to Day 85 -> exclusion after 9 doses due to delayed availability of pos. baseline TB testing result
(no TB activation) Concomitant medication: Adalimumab for psoriasis 40mg q2w since 2017 Target Ulcer Reappeared MH: PG since 2019, Hypertension since 1998 Previous PG medication: Methylprednisolone only in Jun 2019, Dapsone Jun 2019 - Aug
2020, Cyclosporine Oct 2019 - Aug 2020 -> ulcer healed and reappeared after discontinuation of immunosuppressants Cohort 2: 1600 mg Q2W, individual up-titration to 2400 mg at D57, treatment completed Concomitant medication: Prednisone 10
mg for PG since October 20 Day 89 PGA = 1 Area: not yet available Baseline Area: 1136 mm2 Day 85 PGA = 1 Area: 0.00 mm2 Day 189 PGA = 1 Area: 0.00 mm2 Baseline Area: 3695 mm2 Day 99 PGA = 1 Area: 0.00 mm2
PG Phase III Study Design: Interim Analysis Expected in 2025 Page 16 Treatment:
26 Weeks Follow up: 12 Weeks Safety Follow Up Prednisone tapered off Prednisone tapered off Randomization vilobelimab 2400 mg Q2W (13 doses) EOT (W 26) Safety Follow Up Patient Level Stopping Criteria progression (any time) or no
improvement at defined time points 22 20 18 16 14 12 10 0 2 4 6 8 placebo Q2W (13 doses) 24 Week Dosing 26 Arm 1 Arm 2 Arm 1 Arm 2 n approx. = 15 n approx. = 15 Interim Analysis*set rules for size adjustment or
futility stop by IDMC Total number of patients to be adjusted between 50 - 100** Primary endpoint: complete target ulcer closure Adaptive Design * Blinded except for independent data safety monitoring committee / **Adjustment of
randomization ratio to 2:1 (Arm 1 to Arm 2) after blinded interim analysis Screening
INF904: An Oral Highly Selective C5aR Inhibitor With Best-in-Class Potential
INF904: Oral C5aR Antagonist With Best-in-Class Potential Page 18 INF904 Key
Features Focusing on Immuno-Derm, Other Options Possible Favorable drug profile supported by preclinical studies and data reported from InflaRx's Phase I SAD and MAD trials Phase I PK/PD profile that could open significant market
opportunities for the C5aR oral inhibitor class well-tolerated and no safety signals over entire tested dose range (no reported SAEs, AE lower than in placebo group) evidence of broad therapeutic index, BID and QD dosing Has ~3-fold higher