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Share Name | Share Symbol | Market | Type |
---|---|---|---|
InflaRx NV | NASDAQ:IFRX | NASDAQ | Common Stock |
Price Change | % Change | Share Price | Bid Price | Offer Price | High Price | Low Price | Open Price | Shares Traded | Last Trade | |
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-0.01 | -0.83% | 1.19 | 1.11 | 1.42 | 1.30 | 1.18 | 1.30 | 306,652 | 23:02:01 |
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• | the receptiveness of Gohibic (vilobelimab) as a treatment for COVID-19 by COVID-19 patients and U.S. hospitals; |
• | our ability to commercialize our product candidates; |
• | our expectations regarding the size of the patient populations for, market opportunity for, estimated returns and return accruals 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 the emergency use authorization, or 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 biologics license application, or 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 U.S. Food and Drug Administration, or FDA, the European Medicines Agency’s, or 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; |
• | 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 |
• | other risk factors discussed under “Risk Factors.” |
• | Prepare for commercialization of Gohibic (vilobelimab). We continue to prepare for commercialization of Gohibic (vilobelimab) in the United States by investing in our commercial infrastructure and seek partners to support commercialization of our products, including the manufacturing of larger quantities of product candidates for the completion of the development activities towards the establishment of a commercial manufacturing process and for further clinical development. We are also continuing to pursue full BLA and MAA approvals for Gohibic (vilobelimab). |
• | Advance vilobelimab in PG. Based on the positively concluded open label Phase IIa study, we are advancing into a Phase III pivotal clinical program after having received advice related to the clinical trial design from the FDA. |
• | Continue Phase II clinical development of vilobelimab for cSCC and other complement-mediated autoimmune and inflammatory diseases. We are studying the potential benefit of vilobelimab treatment in PD-1/PD-L1 inhibitor resistant/refractory locally advanced or metastatic cutaneous squamous cell carcinoma (cSCC) in an ongoing clinical Phase II proof of concept study. |
• | Complete a Phase I, first in human study with INF904. We are conducting a single and multiple ascending dose study of our C5aR antagonist INF904 with a goal of developing INF904 for the treatment of other complement-mediated auto-immune and inflammatory diseases where a low molecular weight compound is medically needed or desirable for patient care. |
• | Establish a fully validated manufacturing process for vilobelimab. We are establishing a fully validated manufacturing process for vilobelimab with an established and reputable CDMO with the goal of fulfilling the quality criteria to gain regulatory approval for such process. We plan to establish the final manufacturing of the finished pharmaceutical product (i.e., “fill and finish”) in Germany and are considering the transfer of the drug substance manufacturing process from China to Germany or other countries. This effort is supported by the grant we were awarded from the German federal government. |
• | Assess development options for vilobelimab in HS and AAV. Following our decision to halt these two development programs due to the resources required to conduct these on our own, we are currently evaluating options regarding the development of vilobelimab in HS and AAV. Based on the logistical and financial effort necessary to successfully complete pivotal Phase III development programs in each of these two indications, such options include potential collaborations with a pharmaceutical partner. |
• | Pursue the further development of IFX002 to get prepared for potential clinical development. We are developing IFX002 as an injectable with a longer half-life than vilobelimab, making it suitable for chronic inflammatory indications with less severe flares or closer to the onset of disease. Based on a patent lifetime potentially beyond 2040, we see this project as life-cycle management for vilobelimab and are conducting pre-clinical development work to get closer to the possible start of clinical development. |
• | Explore the possibility to expand the applications of vilobelimab into related diseases. We may explore the possibility of expanding the label into other critical care indications for which we have generated pre-clinical data in the past. Most notably, we may consider additional studies to expand the label into a product for virally induced acute respiratory distress syndrome, or virally induced ARDS. |
• | Solidify and continue to expand the breadth of our leadership position in the anti-C5a/anti-C5aR space by leveraging the full potential of our proprietary technologies and expertise in complement and inflammation research. We intend to continue to discover and develop treatments that have the potential to address a broad spectrum of complement-mediated or immune response mediated indications with significant unmet need, either internally or in collaboration with a partner. To accomplish this, we continue to supplement our research and development activities with our discovery unit in Ann Arbor, Michigan and we are further building out our intellectual property portfolio and our business development capabilities. |
• | the sections of the Exchange Act regulating the solicitation of proxies, consents or authorizations in respect of a security registered under the Exchange Act; |
• | the sections of the Exchange Act requiring insiders to file public reports of their stock ownership and trading activities and liability for insiders who profit from trades made in a short period of time; |
• | the rules under the Exchange Act requiring the filing with the SEC of quarterly reports on Form 10-Q containing unaudited financial and other specific information, or current reports on Form 8-K, upon the occurrence of specified significant events; and |
• | certain more stringent executive compensation disclosure rules; instead, we are permitted to follow our home country practice on such matters. |
• | to develop, license, manufacture and commercialize pharmaceutical products; |
• | to develop and commercialize tests and analytical methods; |
• | to participate in, to finance, to hold any other interest in and to conduct the management or supervision of other entities, companies, partnerships and businesses; |
• | to acquire, administer, exploit, invest, encumber and dispose of assets and liabilities; |
• | to furnish guarantees, to provide security, to warrant performance in any other way and to assume liability, whether jointly and severally or otherwise, in respect of obligations of group companies or other parties; and |
• | to do anything that, in the widest sense, is connected with or may be conducive to the objectives described above. |
• | our board of directors, in light of the circumstances at hand when the cooling-off period was invoked, could not reasonably have concluded that the relevant proposal or hostile offer constituted a material conflict with the interests of our company and its business; |
• | our board of directors cannot reasonably believe that a continuation of the cooling-off period would contribute to careful policy-making; or |
• | other defensive measures, having the same purpose, nature and scope as the cooling-off period, have been activated during the cooling-off period and have not since been terminated or suspended within a reasonable period at the relevant shareholders’ request (i.e., no ‘stacking’ of defensive measures). |
• | Executive directors should be appointed for a maximum period of four years, without limiting the number of consecutive terms executive directors may serve. |
• | Non-executive directors should be appointed for two consecutive periods of no more than four years. |
• | a director should report any potential conflict of interest in a transaction that is of material significance to the company and to such director to the other directors without delay, providing all relevant information in relation to the conflict; |
• | the board of directors should then decide, outside the presence of the director concerned, whether there is a conflict of interest; |
• | transactions in which there is a conflict of interest with a director should be agreed on arms’ length terms; and |
• | a decision to enter into such a transaction in which there is a conflict of interest with a director that is of material significance to the company and to such director shall require the approval of the board of directors, and such transactions should be disclosed in the company’s annual board report. |
• | the material facts as to the director’s relationship or interest are disclosed and a majority of disinterested directors consent; |
• | the material facts are disclosed as to the director’s relationship or interest and a majority of shares entitled to vote thereon consent; or |
• | the transaction is fair to the corporation at the time it is authorized by the board of directors, a committee of the board of directors or the shareholders. |
• | options awarded to our executive directors as part of their compensation could (subject to the terms of the option awards) vest and become exercisable during the first three years after the date of grant; |
• | our directors may generally sell our ordinary shares held by them at any point in time, subject to applicable law, company policy and applicable lock-up arrangements; |
• | our non-executive directors may be granted compensation in the form of shares, options and other equity-based compensation; and |
• | our executive directors may be entitled to a severance payment in excess of their respective annual base salaries. |
• | our board of directors, in light of the circumstances at hand when the cooling-off period was invoked, could not reasonably have concluded that the relevant proposal or hostile offer constituted a material conflict with the interests of our company and its business; |
• | our board of directors cannot reasonably believe that a continuation of the cooling-off period would contribute to careful policy-making; or |
• | other defensive measures, having the same purpose, nature and scope as the cooling-off period, have been activated during the cooling-off period and have not since been terminated or suspended within a reasonable period at the relevant shareholders’ request (i.e., no ‘stacking’ of defensive measures). |
• | the authorization of a class of preferred shares that may be issued by our board of directors to the protective foundation, in such a manner as to dilute the interest of any potential acquirer; |
• | the staggered multi-year terms of our directors (with subsequent terms as may be nominated by our board of directors and approved by our general meeting of shareholders), as a result of which only part of our directors may be subject to election or re-election in any one year; |
• | a provision that our directors may only be removed at the general meeting of shareholders by a two-thirds majority of votes cast representing at least 50% of our outstanding share capital if such removal is not proposed by our board of directors; |
• | our directors being appointed on the basis of a binding nomination by our board of directors, which can only be overruled by the general meeting of shareholders by a resolution adopted by at least a two-thirds majority of the votes cast, provided such majority represents more than half of the issued share capital (in which case the board of directors shall make a new nomination); |
• | a provision allowing, among other matters, the former chairman of our board of directors or our former chief executive officer, as applicable, to manage our affairs if all of our directors are removed from office and to appoint others to be charged with the management and supervision of our affairs until new directors are appointed by the general meeting of shareholders on the basis of a binding nomination discussed above; and |
• | requirements that certain matters, including an amendment of our Articles of Association, may only be brought to our shareholders for a vote upon a proposal by our board of directors. |
• | the transaction that will cause the person to become an interested shareholder is approved by the board of directors of the target prior to the transactions; |
• | after the completion of the transaction in which the person becomes an interested shareholder, the interested shareholder holds at least 85% of the voting stock of the corporation not including shares owned by persons who are directors and officers of interested shareholders and shares owned by specified employee benefit plans; or |
• | after the person becomes an interested shareholder, the business combination is approved by the board of directors of the corporation and holders of at least 66 and two-thirds percent of the outstanding voting stock, excluding shares held by the interested shareholder. |
• | a transfer of the business or virtually the entire business to a third party; |
• | the entry into or termination of a long-term cooperation of the company or a subsidiary with another legal entity or company or as a fully liable partner in a limited partnership or general partnership, if such cooperation or termination is of a far-reaching significance for the company; and |
• | the acquisition or divestment by the company or a subsidiary of a participating interest in the capital of a company having a value of at least one-third of the amount of its assets according to its balance sheet and explanatory notes or, if the company prepares a consolidated balance sheet, according to its consolidated balance sheet and explanatory notes in the last adopted annual accounts of the company. |
• | classification as senior or subordinated debt securities; |
• | ranking of the specific series of debt securities relative to other outstanding indebtedness, including subsidiaries’ debt; |
• | if the debt securities are subordinated, the aggregate amount of outstanding indebtedness, as of a recent date, that is senior to the subordinated securities, and any limitation on the issuance of additional senior indebtedness; |
• | the designation, aggregate principal amount and authorized denominations; |
• | the date or dates on which the principal of the debt securities may be payable; |
• | the rate or rates (which may be fixed or variable) per annum at which the debt securities shall bear interest, if any; |
• | the date or dates from which such interest shall accrue, on which such interest shall be payable, and on which a record shall be taken for the determination of holders of the debt securities to whom interest is payable; |
• | the place or places where the principal and interest shall be payable; |
• | our right, if any, to redeem the debt securities, in whole or in part, at our option and the period or periods within which, the price or prices at which and any terms and conditions upon which such debt securities may be so redeemed, pursuant to any sinking fund or otherwise; |
• | our obligation, if any, of the Company to redeem, purchase or repay any debt securities pursuant to any mandatory redemption, sinking fund or other provisions or at the option of a holder of the debt securities; |
• | if other than denominations of $2,000 and any higher integral multiple of $1,000, the denominations in which the debt securities will be issuable; |
• | if other than the currency of the United States, the currency or currencies, in which payment of the principal and interest shall be payable; |
• | whether the debt securities will be issued in the form of global securities; |
• | provisions, if any, for the defeasance of the debt securities; |
• | any U.S. federal income tax consequences; and |
• | other specific terms, including any deletions from, modifications of or additions to the events of default or covenants described below or in the applicable indenture. |
• | subject to Dutch law, any insolvency or bankruptcy proceedings, or any receivership, dissolution, winding up, total or partial liquidation, reorganization or other similar proceedings in respect of us or a substantial part of our property, whether voluntary or involuntary; |
• | (i) a default having occurred with respect to the payment of principal or interest on or other monetary amounts due and payable with respect to any senior indebtedness or (ii) an Event of Default (as defined below) (other than a default described in clause (i) above) having occurred with respect to any senior indebtedness that permits the holder or holders of such senior indebtedness to accelerate the maturity of such senior indebtedness. Such a default or Event of Default must have continued beyond the period of grace, if any, provided in respect of such default or Event of Default, and such a default or Event of Default shall not have been cured or waived or shall not have ceased to exist; and |
• | the principal of, and accrued interest on, any series of the subordinated debt securities having been declared due and payable upon an Event of Default pursuant to the subordinated indenture. This declaration must not have been rescinded and annulled as provided in the subordinated indenture. |
(1) | default in the payment of the principal on the debt securities when it becomes due and payable at maturity or otherwise; |
(2) | default in the payment of interest on the debt securities when it becomes due and payable, and such default continues for a period of 30 days; |
(3) | default in the performance, or breach, of any covenant in the indenture (other than defaults specified in clauses (1) or (2) above) and the default or breach continues for a period of 90 consecutive days or more after written notice to us by the trustee or to us and the trustee by the holders of 25% or more in aggregate principal amount of the outstanding debt securities of all series affected thereby; |
(4) | the occurrence of certain events of bankruptcy, insolvency, or similar proceedings with respect to us or any substantial part of our property; or |
(5) | any other Events of Default that may be set forth in the applicable prospectus supplement. |
• | the rights of registration of transfer and exchange of debt securities, and our right of optional redemption, if any; |
• | substitution of mutilated, defaced, destroyed, lost or stolen debt securities; |
• | the rights of holders of the debt securities to receive payments of principal and interest; |
• | the rights, obligations and immunities of the trustee; and |
• | the rights of the holders of the debt securities as beneficiaries with respect to the property deposited with the trustee payable to them (as described below); when: |
• | either: |
• | all debt securities of any series issued that have been authenticated and delivered have been delivered by us to the trustee for cancellation; or |
• | all the debt securities of any series issued that have not been delivered by us to the trustee for cancellation have become due and payable or will become due and payable within one year or are to be called for redemption within one year under arrangements satisfactory to the trustee for the giving of notice of redemption by such trustee in our name and at our expense, and we have irrevocably deposited or caused to be deposited with the trustee as trust funds the entire amount sufficient to pay at maturity or upon redemption all debt securities of such series not delivered to the trustee for cancellation, including principal and interest due or to become due on or prior to such date of maturity or redemption; |
• | we have paid or caused to be paid all other sums then due and payable under such indenture; and |
• | we have delivered to the trustee an officers’ certificate and an opinion of counsel, each stating that all conditions precedent under such indenture relating to the satisfaction and discharge of such indenture have been complied with. |
• | we must irrevocably have deposited or caused to be deposited with the trustee as trust funds in trust for the purpose of making the following payments, specifically pledged as security for, and dedicated solely to the benefits of the holders of the debt securities of a series: |
• | money in an amount; |
• | U.S. government obligations; or |
• | a combination of money and U.S. government obligations, |
• | we have delivered to the trustee an opinion of counsel stating that, under then applicable U.S. federal income tax law, the holders of the debt securities of that series will not recognize gain or loss for U.S. federal income tax purposes as a result of the defeasance and will be subject to the same federal income tax as would be the case if the defeasance did not occur; |
• | no default relating to bankruptcy or insolvency and, in the case of a covenant defeasance, no other default has occurred and is continuing at any time; |
• | if at such time the debt securities of such series are listed on a national securities exchange, we have delivered to the trustee an opinion of counsel to the effect that the debt securities of such series will not be delisted as a result of such defeasance; and |
• | we have delivered to the trustee an officers’ certificate and an opinion of counsel stating that all conditions precedent with respect to the defeasance have been complied with. |
• | the title of the warrants; |
• | the aggregate number of warrants offered; |
• | the designation, number and terms of the debt securities, ordinary shares or other securities purchasable upon exercise of the warrants and procedures by which those numbers may be adjusted; |
• | the exercise price of the warrants; |
• | the dates or periods during which the warrants are exercisable; |
• | the designation and terms of any securities with which the warrants are issued; |
• | if the warrants are issued as a unit with another security, the date on and after which the warrants and the other security will be separately transferable; |
• | if the exercise price is not payable in U.S. dollars, the foreign currency, currency unit or composite currency in which the exercise price is denominated; |
• | any minimum or maximum amount of warrants that may be exercised at any one time; |
• | any terms relating to the modification of the warrants; |
• | any terms, procedures and limitations relating to the transferability, exchange or exercise of the warrants; and |
• | any other specific terms of the warrants. |
• | the terms of the units and of the ordinary shares, debt securities, warrants and/or purchase contracts comprising the units, including whether and under what circumstances the securities comprising the units may be traded separately; |
• | a description of the terms of any unit agreement governing the units; and |
• | a description of the provisions for the payment, settlement, transfer or exchange of the units. |
• | through underwriters or dealers; |
• | directly to a limited number of purchasers or to a single purchaser; |
• | in “at-the-market” offerings, within the meaning of Rule 415(a)(4) of the Securities Act, to or through a market maker or into an existing trading market on an exchange or otherwise; |
• | through agents; or |
• | through any other method permitted by applicable law and described in the applicable prospectus supplement. |
• | the name or names of any underwriters, dealers or agents; |
• | the purchase price of such securities and the proceeds to be received by us, if any; |
• | any underwriting discounts or agency fees and other items constituting underwriters’ or agents’ compensation; |
• | any initial public offering price; |
• | any discounts or concessions allowed or reallowed or paid to dealers; and |
• | any securities exchanges on which the securities may be listed. |
• | negotiated transactions; |
• | at a fixed public offering price or prices, which may be changed; |
• | at market prices prevailing at the time of sale; |
• | at prices related to prevailing market prices; or |
• | at negotiated prices. |
• | our Annual Report on Form 20-F for the fiscal year ended December 31, 2022 filed on March 22, 2023; |
• | the description of our ordinary shares contained in Exhibit 2.4 of our Annual Report on Form 20-F for the year ended December 31, 2022; |
• | our Forms 6-K filed on April 13, 2023 and May 11, 2023 (excluding Exhibit 99.3); and |
• | the description of our ordinary shares contained in Exhibit 2.4 to our Annual Report on Form 20-F for the year ended December 31, 2022, including any amendments or reports filed for the purpose of updating such description. |
| | Amount To Be Paid | |
SEC registration fee | | | $27,550 |
Transfer agent and trustee fees | | | * |
Legal fees and expenses | | | * |
Accounting fees and expenses | | | * |
Printing expenses | | | * |
Miscellaneous | | | * |
Total | | | $ * |
* | To be provided in a prospectus supplement describing an offering of securities or a report on Form 6-K that is incorporated by reference herein. |
1 Year InflaRx NV Chart |
1 Month InflaRx NV Chart |
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