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Certified Internal Auditor - Part 2, Conducting the Internal Audit Engagement
IIA Conducting techniques
Killexams : IIA Conducting techniques - BingNews https://killexams.com/pass4sure/exam-detail/IIA-CIA-Part2 Search results Killexams : IIA Conducting techniques - BingNews https://killexams.com/pass4sure/exam-detail/IIA-CIA-Part2 https://killexams.com/exam_list/IIA Killexams : Clinical Evaluation Reports: The New Requirement

How did such a game changer come about for the industry? In June 2002, a report by the European Commission’s Medical Device Experts Group (MDEG) concluded that most manufacturers didn’t possess adequate clinical evidence for their medical devices and that most notified bodies didn’t adequately verify the clinical evidence that was provided to them by manufacturers.1 The findings applied to Class I and Class IIa devices, as well as Class IIb and Class III devices.

In addition, the MDEG cited clinical evaluations as a major area of concern. The MDEG is composed of representatives from various organizations in Europe and each member state’s competent authority. The Clinical Evaluation Task Force, a subgroup of the MDEG, proposed the changes found in Directive 2007/47/EC that led to the amendments of MDD 93/42/EEC.2

Europe versus the United States: Direction of Literature Reviews

Both Europe and the United States require literature reviews in the course of conducting clinical trials and commercializing devices. However, Europeans and Americans have a fundamentally different view of their purpose. Europeans believe that a well-conducted literature review will point in a single direction such as: 

? Whether a clinical trial is needed.

? Justification for the trial, if necessary.

? Whether the medical device is ready for commercialization.3

Americans, and FDA, come from a different perspective. The literature review serves specific purposes such as:

? To summarize the state of world knowledge through a report of prior
investigations.

? To establish that a device is substantially equivalent to another device on the market.

? To establish that a device can be used safely under the watchful eye of an
investigator.

? To establish that a device can be used safely in the day-to-day business of healthcare delivery.

The European view anticipates and demands an exhaustive review of the published (and unpublished) literature. For an old product like a wound dressing, this could consist of thousands of articles going back to the time of the ancient Greeks. However, for a familiar product like a tongue depressor, there may be only a limited amount of scientific literature available. The American view expects that a balanced and honest review will be conducted, but once the purpose of the review is fulfilled, the job is complete.

History of Regulatory Literature Reviews

Report of Prior Investigations. The first regulatory requirement for a literature review was circa 1980, when FDA brought forth the concept of a report of prior investigations, 21 CFR Part 812.20(b)(2). The report details prior investigations of the device, the purpose of which was to give the agency a history of device use. The report of priors is a requirement for significant-risk devices that require a full investigational device exemption, and the concept is useful, but not imperative, for clinical trials of nonsignificant-risk devices.4

MDD. Circa 1993, the Europeans raised the bar and said that a literature review constituted clinical evidence and could, in many cases, substitute for new clinical data. The MDD of 1993, Annex X, reads, “The adequacy of the clinical data must be based on either a compilation of the relevant scientific literature currently available on the intended purpose of the device and the techniques employed as well as, if appropriate, a written report containing a critical evaluation of this compilation, or....” This was new territory, because the regulators were overtly stating that retrospective data could adequately substitute for new, prospective clinical data. The provision may have arisen from a European aversion to clinical research.5

 Clinical Investigation Plans. In 2003, ISO 14155-2:2003 further clarified the role of a literature review in clinical trials. Part 2 in 4.5.1 states, 

The clinical investigation plan shall contain a critical review of the relevant scientific literature and/or unpublished data and reports together with a list of the literature reviewed. The conclusions from this review shall justify the design of the proposed investigation. The review shall be relevant to the intended purpose of the device to be investigated and the proposed method of use. It should also help in the identification of relevant end points and confounding factors that should be considered, and the choice and justification of control methods.6

Even further guidance was offered in Annex A of ISO 14155 Part 1, in which
performance of a literature review took on the aspects of the scientific method and was based on the groundbreaking work done by the Cochrane Collaboration.

It’s useful to remember that the ISO 14155 standards are adopted by the Committee for European Normalization and incorporated by reference into the directives. They therefore become de facto regulation in Europe, and the European device industry has a huge stake in how the standards are worded.

The Global Harmonization Task Force (GHTF). In 2007, GHTF Study Group 5 published guidances on CE reports. They further emphasized the preference for using retrospective data in lieu of prospective clinical data with the statement, “Clinical evaluation of medical devices that are based on existing, well-established technologies and intended for an established use of the technology is most likely to rely on compliance with recognized standards and/or literature review and/or clinical experience of comparable devices.”7

Harmonizing European Union Directives with GHTF Guidances. An important policy that has slipped past most Americans is the European plan to harmonize the MDD and the European Commission’s Medical Device Guidance Documents (MEDEVs) with GHTF guidances. In an open statement issued by the notified bodies, it is “Europe’s intention to integrate GHTF guidance into the European legal framework to as full an extent as possible...[and] to replace the first part of the MEDEV on clinical evaluation with the GHTF document.”

This statement is significant because as Europe and GHTF become closer, the preference for retrospective data over prospective data for device commercialization is strengthened. Furthermore, it forces the hand of the ISO Technical Committee 194 WG4, the working group struggling to bring the 2008 ISO standard into the 21st century, to accommodate policies in the GHTF guidance and politicize the science of clinical research.

Although fewer clinical trials are required in Europe, and devices come to market years and even decades sooner than in the United States, some European citizens feel that they are the guinea pigs of the Western world. In the spring of 2009, the European Medicines Agency made a play for taking over regulation of the device industry with backing from the European Commission. However, the move was succesfully blocked by the device industry, with the outcome that the industry has taken better control of its own regulation. One result is the requirement for new or updated CE reports for all medical devices sold in Europe.

CE Reports: A Three-Legged Stool. Think of a CE report as a three-legged stool. One leg is a report of any newly conducted clinical investigations of a device. Another leg is a report on unpublished data, such as biological safety data, bench testing data, or complaint and experience records. The final leg is a literature review of clinical investigations published on similar devices. For established devices, the literature review may serve as the primary source of clinical evidence to support commercialization and may justify not conducting new clinical investigations.

Methods Guide for Effectiveness and Comparative Effectiveness Reviews. The U.S. Agency for Healthcare Research and Quality (AHRQ) has prepared an extensive document on reviewing the literature.8 First published in 2007 as a 128-page draft, this ongoing effort to write a comprehensive methods guide is periodically updated and is available for free from the AHRQ Web site or from the Journal of Clinical Epidemiology. The AHRQ document is far more useful and complete, but it doesn’t have regulatory standing in the United States or Europe.

Databases. A note to Americans: it isn’t enough to search Medline. Even though this free, online database from the National Library of Medicine includes more than
19 million citations, dating back to 1948, about 2000 global medical journals aren’t included. To access medical journals, one needs to search Embase.

Embase, owned by Elsevier Publishing, can be accessed in at least three ways. The first is via subscription to embase.com, which provides access to both Embase and Medline citations through a Web-based front-end program. The embase.com site uses either full-featured Boolean logic or user-friendly check boxes for searches. Embase, without the inclusion of Medline, can also be accessed through subscriptions to Ovid or Dialog, which offer different front-end programs, and financial and service packages. To do a Europe-friendly literature search, access to Embase is necessary.

Methodology

One thing that Europeans and Americans agree on is how to do a scientifically sound literature review (see the sidebar “How to Do a Literature Review in 10 Easy Steps” on p. 78).

Duration and Timeline. CE reports vary in length from 30 to 300 pages. Two experts, who have written about 80 CE reports between them, indicate their past experience is that CE reports averaged about 30 to 40 pages for Class I and Class IIa devices. However, the British Standards Institute indicated that a 270-page technology assessment report from AHRQ represented the depth and breadth in which notified bodies would be looking in the future.9 See Figure 1 for an example of a CE report task timeline.

Article Weighting. Article weighting is the idea of assessing the data in one article as more valuable than data from another article (see Table I). The literature appraiser may choose to use other criteria or additional criteria. What matters is that the weighting criteria can be justified. For example, a comparison of risk factors might be useful.

Data Weighting. Data weighting focuses more on the quality and integrity of data (see Table II). For example, is the data from a well-controlled clinical study or from an observational registry study? Again, the appraiser may choose to use other criteria. For example, a comparison of biocompatibility data may be important.

Report Format. The CE report will have a predictable format and will include the following:

? Date of search.

? Name of the literature appraiser(s).

? Period covered by search.

? Purpose of the review.

? Description of the device.

? Intended use, indications for use, and claims.

? Selection criteria for literature articles, including sources of articles and reasons for rejection of articles.

? Keywords used for searching databases.

? Summary and grading of clinical data.

? Analysis of existing safety and complaint data, and new clinical data.

? Conclusions.

? Attached copy of search protocol.

? Attached curriculum vitae of appraisers.

? Attached full text copies of articles.

The Reviewer or Appraiser. The review should be conducted by suitably qualified individuals, who are called appraisers in Europe. The manufacturer must be able to justify the choice of the reviewer through reference to qualifications and documented experience. As a general rule, reviewers should understand the device technology and its application, research methodology for clinical investigations and biostatistics, and diagnosis and management of the device’s indications for use.

How to Do a Literature Review in 10 Easy Steps

  1. Identify the purpose of the review.
  2. Identify the article sources: i.e., Medline, Embase Google, abstracts or full articles, reviewed scientific literature, or unreviewed or unpublished data.
  3. Decide on any filters or limitations: e.g., no articles before 1985, only articles on a well- defined course or articles that relate to the device’s indication for use.
  4. Gather the abstracts and list them in a table.
  5. Read the abstracts; some may be excluded. Perhaps there are two articles about the same study. State the reason for exclusion in the table.
  6. Read the remaining articles in full text and exclude the articles that are redundant, irrelevant, or unusable for other reasons, and state the reason for exclusion in the table.
  7. Weigh each article according to relevant criteria.
  8. Analyze the data with regard to the number of patients, success or failure of device, adverse events, etc.
  9. Draw conclusions based on original purpose of the review.
  10. Prepare a report.

Conclusion

With the new amendments coming into force in March 2010, notified bodies are marching their way through their product files, notifying manufacturers that a new or updated CE report is due on nearly every registered device. Manufacturers have waited until the last minute and are suddenly realizing that they may have a dozen reports all due within the next few months. Notified bodies are concerned, too. They don’t have the staff to review hundreds of reports within the space of a few weeks, and the amendments do not provide for a phase-in period. What will happen to devices that don’t have updated reports when the deadline arrives is yet to be decided.

References

1. MDEG, “Report on the Functioning of the Medical Devices Directive,” (London, The British Standards Institution, 5 June 2002); available from Internet: www.bsigroup.com/upload/Standards%20&%20Publications/Healthcare/MDDReport2002.pdf.

2. Directive 2007/47/EC of the European Parliament and of the Council of 5 September 2007 Amending Council Directive 90/385/EEC on the Approximation of the Laws of the Member States Relating to Active Implantable Medical Devices, Council Directive 93/42/EEC Concerning Medical Devices and Directive 98/8/EC Concerning the Placing of Biocidal Products on the Market, Official Journal (OJ) of the European Union, L 247/21, 21 September 2007; available from Internet: http://eur-lex.europa.eu/
LexUriServ/LexUriServ.do?uri=OJ:L:2007:247:0021:0055:en:PDF.

3. G Bos, “Europe in Confusion, MDD Recast Delayed, ISO Declined,” Clinical Device Group, e-Conference, April 8, 2009; available from Internet: www.clinicaldevice.com/mall/
eConferenceCD.aspx.

4. Code of Federal Regulations, 21 CFR 812, Investigational Device Exemptions; available from Internet: www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfCFR/CFRSearch.cfm?CFRPart=812.

5. Council Directive 93/42/EEC of 14 June 1993 Concerning Medical Devices, OJ, L 169; available from Internet: http://eur-lex.europa.eu/LexUriServ/LexUriServ.do?uri=CELEX:31993L0042:EN:NOT.

6. ISO 14155-2:2003, Clinical Investigation of Medical Devices for Human Subjects, Part 2: Clinical Investigation Plans, (Geneva: International Organization for Standardization, 2003); available from Internet: www.iso.org/iso/iso_catalogue/catalogue_tc/catalogue_detail.htm?csnumber=32217.

7. “SG5 Final Documents,” Global Harmonization Task Force, June 2007; available from Internet: http://ghtf.org/sg5/sg5-final.html.

8. ”Methods Guide for Effectiveness and Comparative Effectiveness Reviews,” (Rockville, MD, Agency for Healthcare Research and Quality [AHRQ], August 24, 2009); available from Internet: http://effectivehealthcare.ahrq.gov/index.cfm/search-for-guides-reviews-and-reports/
?pageaction=displayproduct&productID=318.

9. Negative Pressure Wound Therapy, Technology Assessment Report, (Rockville, MD, AHRQ, June 2009); available from Internet: www.ahrq.gov/clinic/ta/negpresswtd.

Nancy J. Stark is president of Clinical Device Group Inc. (Chicago).

Sun, 17 Jul 2022 11:59:00 -0500 en text/html https://www.mddionline.com/news/clinical-evaluation-reports-new-requirement
Killexams : Contemporary Pacemaker and ICD Lead Management

Procedural Requirements

Extraction of chronically implanted leads generally occurs either in the operation theater or European Pharmacopoeia laboratory, depending on institutional and operator preference, and room availability, with proponents of both approaches. The degree to which these preparations occur may alter with the expected difficulty of the procedure; however, it is important to remember that complications may occur with relatively new leads; for example, 1-year-old leads, even though it is less probable than with older leads, and preparation of worst-case scenario issues can prevent morbidity and mortality. Regardless of the location, there are several key factors to the safe removal of chronic leads.

Staffing

While staffing may vary, it is a key to have adequate staffing for the extraction procedure as well as for urgent surgical intervention should it be required. This includes the availability of a cardiac surgeon, anesthetist, scout and scrub nurses, and perfusionist as well as the normal cardiac European Pharmacopoeia Lab staffing. Delays of longer than 5–10 min in obtaining thoracotomy access are associated with a significant mortality. Having a skilled and experienced device extraction specialist is key in reducing complications and increasing success rates. The greatest reduction in complications occurs in the first 30 cases examined but continues to reduce over time even into several hundred cases.

Patient Preparation

Adequate patient preparation involves fully informed consent and understanding of the procedure with both the patient and relatives. Initial pathology testing should be performed as for all cardiac surgical cases and the availability of cross-matched units of blood ensured. Baseline echocardiographic (transesophageal echocardiography [TEE]) assessment of the leads, including looking for the presence of vegetations, valve and cardiac function, is essential. Scrubbing and preparation of the body surfaces as if for thoracotomy, including the placement of defibrillator pads on the lateral surfaces, at the beginning of the case, can prevent unnecessary delays should surgical intervention be required. The presence of an arterial line is also mandatory for the early detection of hemodynamic compromise. It is preferred to undertake extraction under general anesthesia with a cardiac-trained anesthetist proficient in TEE.

Space & Equipment

The presence of enough space for all required staff and equipment is essential. Preparation of the required equipment as though thoracotomy was to be performed and checking equipment function as would normally occur prior to that operation can lead to an expeditious intervention should it be required.

Imaging

Sufficient fluoroscopic imaging quality to be able to see the path of the leads, the position of the locking stylet distally in the lead, the orientation of sheaths and position of snares is essential. Fluoroscopic monitoring of the cardiac shadow may also be useful in detecting motion abnormalities that can give clues as to the development of pericardial bleeding. In addition to this, intraoperative monitoring of cardiac and valve function using TEE may be of great assistance but is not used in all centers.

Rhythm Support

Prior to removal of the leads, it is important to determine the patient's requirement for further rhythm support – both in the short and long term (i.e., reimplantation). While the patient may have an intrinsic rhythm at the beginning of the case, it should be remembered that damage to conducting tissue, either transient or permanent, may occur during the extraction procedure, and the facility to provide rapid rhythm support (e.g., a venous sheath) can prevent unnecessary delays. For patients requiring reimplantation, a temporary active fixation system may be used as a bridge while antibiotics are given.

Wed, 06 Jul 2022 12:00:00 -0500 en text/html https://www.medscape.com/viewarticle/769840_5
Killexams : Aussie miner finds $102 million pink diamond - largest found in 300 years </head> <body id="readabilityBody" readability="27.956867196368"> <h3>Newscorp Australia are trialling new security software on our mastheads. If you receive "Potential automated action detected!" please try these steps first:</h3> <ol type="1"> <li>Temporarily disable any AdBlockers / pop-up blockers / script blockers you have enabled</li> <li>Add this site in to the allowed list for any AdBlockers / pop-up blockers / script blockers you have enabled</li> <li>Ensure your browser supports JavaScript (this can be done via accessing <a href="https://www.whatismybrowser.com/detect/is-javascript-enabled" target="_blank">https://www.whatismybrowser.com/detect/is-javascript-enabled</a> in your browser)</li> <li>Ensure you are using the latest version of your web browser</li> </ol> <p>If you need to be unblocked please e-mail us at accessissues@news.com.au and provide the IP address and reference number shown here along with why you require access. News Corp Australia.</p><p>Your IP address is: 108.167.164.204 | Your reference number is: 0.5cc51160.1660078239.73727a1</p> </body> </description> <pubDate>Wed, 27 Jul 2022 12:03:00 -0500</pubDate> <dc:format>text/html</dc:format> <dc:identifier>https://www.news.com.au/finance/business/mining/largest-pink-diamond-found-in-300-years-discovered-at-australian-site-in-angola/news-story/324de3e7c6aa0ad1debfedfc2d7b73c1</dc:identifier> </item> <item> <title>Killexams : Internal Audit Graduate Scheme

During this 24-month Programme you will be working with our Internal Audit function. The Internal Audit function at Lloyd’s sits within the Office of the CEO and has a strategic role to play in ensuring all risk management, governance and control processes are operating effectively.

You would have the opportunity to work on a range of audits across a variety of business functions, including our international offices.

Whilst on the Programme you will have the opportunity to choose a qualification route that suits you. Whether that’s becoming chartered by the Institute of Internal Auditors or becoming a qualified accountant, Lloyd’s will support you throughout.

Mon, 28 Mar 2022 03:52:00 -0500 en text/html https://www.lloyds.com/about-lloyds/careers/early-careers/graduates/internal-audit-graduate-scheme
Killexams : Chemistry Course Listing Applied Chemistry for Non-Scientists (Formerly 84.101)

Description

Provides an understanding of basic chemical principles -- atomic structure, bonding and interparticle forces, physical and chemical properties of matter through hands-on examination of matter and the application of principles to understanding the chemistry of current issues (e.g., environmental chemistry, biochemistry, food and drug chemistry) and the analysis of problems dealing with these issues. This course is not available for credit for Science or Engineering majors.

Prerequisites

Not for Science and Math Majors.

Forensic Science for the Non-Scientist (Formerly 84.102)

Description

This course presents the inherently fascinating syllabus of crime and criminal investigations as a pathway for teaching the fundamental chemical concepts most often covered in an introductory non-majors course. This course capitalizes on the surge of interest in the scientific investigation of crime (as sparked by CSI and other television shows) and will collate the theme of forensic science with the fundamentals of chemistry. The course material will be continually updated with each offering.

Prerequisites

Not for Science and Math Majors.

Consumer Science 4-1-1: An Essential Guide

Description

This course introduces chemical principles through the context of examining current and topical consumer items such as drugs, food, dietary supplements and personal care products. Information presented will enhance awareness and confidence in understanding the products, scientific reports, news articles and making decisions about the utilization of available products. Chemistry 1040 is a combined lecture and lab demonstration course for non-science majors designed to fulfill the science with lab perspective (SCL) breadth of knowledge degree requirement.

Intro to the Discipline of Chemistry (Formerly 84.105)

Description

This course provides an introduction to chemistry as a career. Required of chemistry majors, it discusses historical aspects of the field and modern career paths, including academic and industrial chemistry. Students are presented with information regarding career opportunities in chemistry, including: analytical/environmental, forensics, inorganic, organic, materials, pharmaceutical/biochemistry, polymer, and theoretical/physical. They are also given an introduction to graduate school and teaching opportunities often pursued following the B.S. degree. In addition to lectures by the instructor, guests from industry and government laboratories are invited to discuss "what it means to be a chemist".

Prerequisites

Pre-Req: Students must be declared Chemistry majors

General Chemistry I (Formerly 84.111)

Description

Provides a one-semester survey of inorganic chemistry: the structure and properties of matter, chemical reactions, stoichiometry, gas laws, solution chemistry, kinetics, equilibrium, and acid-base chemistry.

Prerequisites

Co-Req: 84.113 General Chemistry Lab I and Anti-Req: CHEM.1210 and CHEM.1350.

General Chemistry II (Formerly 84.112)

Description

Surveys the basic principles of organic chemistry and biochemistry with emphasis on biochemical aspects of carbohydrates, lipids, proteins and nucleic acids. Various metabolic pathways are also emphasized.

Prerequisites

Pre-Req: CHEM 1110 General Chemistry I; Co-Req: CHEM 1140L General Chemistry Lab II and Anti-Req: CHEM.1220 and CHEM.1360.

General Chemistry Laboratory I (Formerly 84.113)

Description

Lab experiments designed to illustrate the principles covered in 84.111.

Prerequisites

Co-Req: CHEM.1110 General Chemistry I.

General Chemistry Laboratory II (Formerly 84.114)

Description

Uses laboratory experiments designed to illustrate the principles discussed in 84.112.

Prerequisites

Pre-Req: CHEM 1130L General Chemistry Lab I; Co-Req: CHEM 1120 General Chemistry II.

Principles of Chemistry (Formerly 84.115)

Description

The course provides an introduction to the basic concepts of Chemistry with an emphasis on critical thinking, problem-solving, and computational skills required for more advanced Chemistry courses. syllabus include measurement, chemical calculations, problem solving logic, units analysis, chemical reactions, the periodic table, basic bonding theory and solutions. No previous Chemistry experience is assumed. There is no lab component to this course.

Chemistry I (Formerly 84.121)

Description

Provides an introduction to the basic concepts of chemistry through classroom discussions and demonstrations. syllabus include chemical calculations, atomic structures, the periodic table, basic bonding theory, solutions, liquids, and gases. Restricted to science, engineering, and engineering technology majors.

Prerequisites

Co-Req: CHEM.1230L Chemistry I Lab and Anti-Req: CHEM.1110 and CHEM.1350; Anti-Req: Students only can receive credit for one of the following freshmen-level chemistry I lecture/lab courses: CHEM.1110/1130L, CHEM.1210/1230L; or CHEM.1350/1230L.

Chemistry II (Formerly 84.122)

Description

Serves as a continuation of CHEM.1210. syllabus include thermodynamics; kinetics, acids and bases; an introduction to organic chemistry; chemical equilibrium; precipitation reactions; and electrochemistry. Restricted to science, engineering, and engineering technology majors.

Prerequisites

Pre-Reqs: CHEM 1210 Chemistry I or CHEM 1170 Selected syllabus in Chemistry; Co-Req: CHEM 1240L Chemistry II Lab and Anti-Req: CHEM.1120 and CHEM.1360.

Chemistry I Laboratory (Formerly 84.123)

Description

Studies experimental chemical principles and chemical transformation that is coordinated with syllabus considered in 84.121. Some of the more important reactions of elements, oxides, acids, bases, and salts are examined. Other syllabus include chemical separation, purification, preparation of inorganic salts, quantitative determinations dealing with the formula of a compound, gas laws, and colligative properties. Careful techniques and precise measurements are stressed. Restricted to science, engineering, and engineering technology majors

Prerequisites

Co-Req: CHEM 1210 Chemistry I.

Chemistry II Laboratory (Formerly 84.124)

Description

Serves as a continuation of the laboratory study begun in CHEM.1230L that is coordinated with syllabus of CHEM.1220. syllabus include: thermochemistry, kinetics, spectroscopy, titration, pH, equilibrium reaction and constants. Some aqueous solution reactions and organic reactions are examined. Accurate measurements and precise instrumental and apparatus operation are expected. Restricted to science, engineering, and engineering technology majors.

Prerequisites

Co-Req: CHEM 1220 Chemistry II or 84.119 Selected Topics/Chemistry Lab.

Honors Chemistry I (Formerly 84.135)

Description

A more in-depth view of the syllabus covered in Chemistry I, (84.121). syllabus include chemical reactions and calculations, atomic history and structures, the behavior of gases and bonding theory. Open to students enrolled in the Honors Program, and may be taken instead of 84.121.

Prerequisites

Co-Req: CHEM.1230L Chemistry I Lab and Anti-Req: CHEM.1110 and CHEM.1350; Anti-Req: Students only can receive credit for one of the following freshmen-level chemistry I lecture/lab courses: CHEM.1110/1130L, CHEM.1210/1230L; or CHEM.1350/1230L.

Honors Chemistry II (Formerly 84.136)

Description

A continuation of 84.135. A more in-depth view of the syllabus covered in Chemistry II (84.122). syllabus include solutions, kinetics, thermodynamics, acids and bases, chemical equilibrium, electrochemistry and solubility. Open to students enrolled in the Honors Program, and may be taken instead of 84.122.

Prerequisites

Pre-Req: CHEM 1210 Chemistry I; or CHEM 1350 Honors Chemistry I; and Co-Req: CHEM 1240L Chemistry II Lab and Anti-Req: CHEM.1120 and CHEM.1220.

Introduction to Organic and Polymer Chemistry (Formerly 84.204)

Description

This course is a one-semester overview of organic chemistry for plastics engineering majors. Organic chemistry and its associated principles underscore a broad component of the plastics engineering curriculum. It is desirable therefore for such students to develop a basic appreciation of the fundamental reactions in organic chemistry, as well as an understanding of the interaction of organic compounds with their environment. Students will therefore be expected to secure a basic undersanding of, e.g., chemical bonding, the chemistry of alkanes, alkenes, alkynes, aromatic compounds, substitution and elimination reactions, reactions of organic alcohols, ethers, epoxides, aldehydes and ketones, carboxylic acids, and amine compounds. When appropriate, examples will be provided that relate to those typical polymerization reactions (e.g. free-radical or ionic) employed to manufacture commercial polymer materials. Coverage will include synthesis of organic chemicals and polymers from natural and sustainable materials.

Prerequisites

Pre-Req: CHEM 1210 Chemistry I; Plastics Engineering majors only.

Principles Of Organic Chemistry Laboratory (Formerly 84.205)

Description

Introduction to the basic skills and techniques used in the synthesis, purification, and characterization of representative organic compounds. Open to Chemical Engineering students only.

Prerequisites

Co-req: CHEM.2220 Organic Chemistry IIA and Chemical Engineering Students Only.

Organic Chemistry I (Formerly 84.221)

Description

CHEM.2210 is the first course of a two-semester sequence of organic chemistry for students majoring in Chemistry, Chemical Engineering, Biological Sciences as well as pre-medical, pre-dental, pre-pharmaceutical and pre-veterinary students. The course focuses on acid-base properties, functional group labels, conformational analyses, sterochemistry, substitution, elimination and addition reactions of organic molecules. Curved arrow mechanisms and the relationship between organic structure and reactivity are emphasized. Aspects of organic spectroscopy are also introduced.

Prerequisites

Pre-req: CHEM.1220 Chemistry II, and CHEM.1240L Chemistry II Lab, and Co-req: CHEM.2270L Organic Chemistry IA Lab, or CHEM.2290L Organic Chemistry IB Lab, and Biology, or Chemistry, or Chemical Engineer, or Biomedical Engineer Majors, or PMED, or PDEN.

Organic Chemistry IIA (Formerly 84.222)

Description

A continuation of CHEM.2210 including an introduction to infrared and NMR spectroscopy and biochemistry. The application of organic reactions in multi-step synthesis is stressed.

Prerequisites

Pre-Reqs: CHEM 2210 Org Chemistry I with grade of D or better; or Spring 2020 grade of "P". Co-Req: CHEM 2280L (Chemistry majors only) or CHEM 2300L Org Chemistry Lab II.

Organic Chemistry IIB (Formerly 84.223)

Description

The course covers the chemical and mechanistic principles of organic reactions utilized in biological systems. Spectroscopy, organic reactions and related mechanisms of bio-molecules or small molecules in biological systems will be discussed from a functional group perspective. Multiple examples from medicinal chemistry, chemical biology and biochemistry will be used to illustrate the concepts. Knowledge of organic mechanistic arrow-pushing formalism is required.

Prerequisites

Pre-Reqs: CHEM 2210 Org Chemistry I, and CHEM 2290L Organic Chemistry Laboratory IB ; Co-Req: CHEM 2300L Organic Chemistry Lab IIB, and Biology Majors Only.

Organic Chemistry Laboratory IA (Formerly 84.227)

Description

Laboratory work designed to emphasize the techniques of organic synthesis and the use of instrumentation for identification and characterization of organic compounds. Required for chemistry majors.

Prerequisites

Co-req: CHEM.2210 Organic Chemistry IA and Chemistry Majors Only.

Organic Chemistry Laboratory IIA (Formerly 84.228)

Description

A continuation of 84.227 including an introduction to semimicro organic techniques. Planning and successfully carrying out reactions published in the chemical literature are emphasized. Required for chemistry majors.

Prerequisites

Pre-reqs: CHEM 2210 Organic Chemistry IA, CHEM 2270L Organic Chemistry Lab II; Co-reqs: CHEM 2220 Organic Chemistry IIA, CHEM 2600 Info Retrieval. For Chemistry Majors Only.

Organic Chemistry Laboratory IB (Formerly 84.229)

Description

Reviews techniques, skills, and heuristic approaches in the synthesis, purification, and identification of organic compounds. IR, GC, and NMR instrumental methods are included. For Biology and Health Science majors.

Prerequisites

Co-Req: CHEM.2210 Organic Chemistry I for Biology and Health Science and Biomedical Engineering majors.

Organic Chemistry Lab IIB (Formerly 84.230)

Description

A continuation of 84.229/CHEM 2290L. Biology and Health Science Majors.

Prerequisites

Co-Req: CHEM 2220 or CHEM 2230 Organic Chemistry II for Biology and Health Science Majors.

Information Retrieval (Formerly 84.260)

Description

An introduction to the important chemical and chemical-related reference sources including journals, patents, technical publications, and compiled reference works, and instructions in their use. Assignments require the use of each source discussed. On-line searching using computerized chemical and chemical related databases is also introduced. Meets Core Curriculum Essential Learning Outcome for Information Literacy (IL).

Prerequisites

Co-Req: CHEM.2280L Organic Chemistry Lab II.

Undergraduate Independent Study

Description

This is a guided study course for students who are working in a research lab or another types of chemistry-based research. Students will work with a faculty mentor to design and conduct a research project during the semester and they will prepare a report of their findings at the end of the semester. Credits earned in this course cannot be used to fulfill the advanced Chemistry elective courses or requirements for the Chemistry minor. This course can only be used for up to 3 hours of free elective credit.

Special Topics: Chemistry (Formerly 84.301)

Description

There is currently no description available for this course.

Forensic Science I (Formerly 84.303)

Description

Introduction to Forensic Science, Fundamental statistics, Data Sampling &amp; Quality Multivariate statistics, calibration and quality, Partitioning, thin-layer chromatography, Immunoassay, Instruments, Introduction to drug and pharmacology.

Prerequisites

Co-Req: CHEM 3050L Forensic Science I Lab; Pre-Reqs: CHEM 2220 Org Chem IIA, PHYS 1440 Physics II, and MATH 2310 Calculus III.

Forensic Science II (Formerly 84.304)

Description

Drug Analysis I, Drug Analysis II, Chemistry of combustion and Arson, Chemistry of color and colorants, Analysis of ink and paints, Chemistry of polymers, Analysis of fibers and papers.

Prerequisites

Co-Req: CHEM 3060L Forensic Science II Lab; and Pre-Reqs: CHEM 3030/305 Forensic Science I/Forensic Science I Lab.

Forensic Science I Laboratory (Formerly 84.305)

Description

Locard's exchange principle, Reagent preparation, crime scene investigation, a case of deductive reasoning, crime scene sketching, Forensic glass analysis, Fingerprint, Introduction to Microscopy, Color perception. Meets Core Curriculum Essential Learning Outcome for Applied &amp; Integrative Learning (AIL).

Prerequisites

Co-Req: CHEM 3030 Forensic Science I; Pre-Reqs: CHEM 2220 Org Chem IIA, PHYS 1440 Physics II, and MATH 2310 Calculus III.

Forensic Science II Laboratory (Formerly 84.306)

Description

Forensic hair analysis, Handwriting comparison, Fluorescence detection of drug, Introduction to Immunoassay and enzyme catalysis, Fluorescence microscopy Analysis of gunshot residues, Analysis of metal, Analysis of flammable.

Prerequisites

Co-Req: CHEM 3040 Forensic Science II; and Pre-Reqs: CHEM 3030/305 Forensic Science I and Forensic Science I Lab.

Analytical Chemistry I (Formerly 84.313)

Description

Focuses on the evaluation of analytical data, aqueous and non-aqueous acid-base systems, oxidation reduction and complexation equilibria, solubility and precipitation, solvent extraction, ion-exchange and chromatographic methods.

Prerequisites

Co-Req: 84.315 Analytical Chem Lab I.

Analytical Chemistry II (Formerly 84.314)

Description

Introduces modern instrumental methods of chemical analysis. syllabus to be discussed include ultraviolet, infrared nuclear magnetic resonance, emission and atomic absorption spectroscopy. Mass spectrometry, chromatography, thermal and electrochemical methods of analysis will also be covered.

Prerequisites

Pre-Reqs: CHEM 3130 Analytical Chem I, PHYS 1440 Physics II; Co-Reqs: CHEM 3160L Analytical Chem II Lab, CHEM 3450 Physical Chemistry II.

Analytical Chemistry Laboratory I (Formerly 84.315)

Description

Experiments emphasizing the syllabus presented in 84.313 are conducted.

Prerequisites

Co-Req: 84.313 Analytical Chem I.

Analytical Chemistry Laboratory II (Formerly 84.316)

Description

Presents laboratory experiments designed to complement the coverage of syllabus in 84.314.

Prerequisites

Pre-Reqs: CHEM 3130 Analytical Chem I, CHEM 3150L Analytical Chem Lab I; Co-Req: CHEM 3140 Analytical Chemistry II.

Physical Chemistry Principles (Formerly 84.339)

Description

A one-semester course designed for plastics engineering majors. Physical chemical concepts of importance to plastics and polymeric materials are emphasized and include kinetics, spectroscopy, phase rule, and statistical thermodynamics.

Prerequisites

Pre-Reqs: CHEM 1220 Chemistry II and PLAS 2470 Thermodynamics.

Physical Chemistry I (Formerly 84.344)

Description

Covers basic physical chemical topics: laws of thermodynamics, solutions, chemical and phase equilibria, electrochemistry, kinetics, atomic, and molecular structure. Meets Core Curriculum Essential Learning Outcome for Quantitative Literacy (QL).

Prerequisites

Pre-Req: MATH 2310 Calculus III, CHEM 1220 Chemistry II, PHYS 1410 Physics I; Co-Req CHEM 3460L Physical Chem Lab I or Chemical Engineering (BS) or Chemistry (BS).

Physical Chemistry II (Formerly 84.345)

Description

CHEM.3450 serves as a continuation of CHEM.3440. syllabus covered include the failures of classical physics that led to the rise of quantum mechanics, the postulates of quantum mechanics, the particle-in-a-box, the harmonic oscillator, the rigid rotator, the hydrogen atom and multi-electron atoms. Applications of these quantum mechanical models to chemistry and spectroscopy are discussed, along with aspects of chemical bonding.

Prerequisites

Pre-Req: CHEM.3440 Physical Chemistry I and (MATH.2340 Differential Equations or MATH.2360 Eng. Differential Equations).

Physical Chemistry Laboratory I (Formerly 84.346)

Description

Laboratory work designed to exemplify principles covered in 84.344. Required for chemistry majors. Meets Core Curriculum Essential Learning Outcome for Critical Thinking &amp; Problem Solving (CTPS).

Prerequisites

Pre-Req: CHEM 1240L Chemistry II Lab; Co-Req: CHEM 3440 Physical Chemistry I.

Physical Chemistry Laboratory II (Formerly 84.347)

Description

Provides laboratory work designed to exemplify the principles of chemical kinetics, equilibrium, and spectroscopy.

Prerequisites

Pre-req or Co-req: CHEM.3440 Physical Chemistry I.

Physical Bioinorganic Laboratory (Formerly 84.350)

Description

Coordination compounds are utilized in a core of experiments to illustrate basic physiochemical techniques and analysis of experimental data in electrochemistry and kinetics. A project lab is carried out to apply and extend techniques learned.

Prerequisites

Pre-Reqs: CHEM 3440 Physical Chemistry I and CHEM 3460L Physical Chemistry Lab I.

The Responsible Chemist (Formerly 84.360)

Description

This course is required of chemistry majors and addresses ethical, regulatory, and environmental aspects of their profession. Students are exposed to a wide range of research integrity issues that include TSCA (Toxic Substance Control Act), SOPs (Standard Operating Procedures) and quality management. Compliance issues include an overview of OSHA (Occupational Safety and Health Administration) and EPA (Environmental Protection Agency), as well as an introduction to patent law. The importance of maintaining integrity in their discipline is emphasized, and case studies are presented for study and discussion. Meets Core Curriculum Essential Learning Outcome for Social Responsibility &amp; Ethics (SRE) and Essential Learning Outcome for Written &amp; Oral Communication (WOC).

Prerequisites

Chemistry Majors Only

Organic Synthesis and Characterization Lab

Description

An advanced project-based organic chemistry laboratory course. Students will separate mixtures of compounds by chromatographic methods, elucidate structures using spectroscopic techniques and consult the chemical literature to design and execute a multi-step synthesis. Emphasis on laboratory work with discussion of theoretical background.

Prerequisites

Pre-req: CHEM.2220 Organic Chem IIA, or CHEM.2230 Organic Chem IIB, and CHEM.2280L Organic Chem Lab IIA, or CHEM.2300L Organic Chem Lab IIB, or CHEM.2050L Principles of Organic Chem Lab.

Polymer Science I (Formerly 84.403)

Description

Coverage of step and chain growth polymerizations, kinetics and mechanism, copolymerization, ionic and free radical polymerizations, and industrially important polymers.

Prerequisites

Pre-Req: 84.222 Organic Chemistry IIA or 84.203 Princ of Organic Chem or 84.345 Physical Chemistry II.

Undergraduate Thesis (Formerly 84.407)

Description

Research in biochemistry, electrochemistry or analytical, organic, inorganic, physical or polymer chemistry. Progress report required.

Undergraduate Thesis II (Formerly 84.408)

Description

A continuation of 84.407. Both semesters must be taken and not more than six credits may be used in meeting degree requirements. A written thesis and seminar are required. The written thesis is to follow the conventional form of introduction, literature survey, data, results, and conclusions. One copy of the thesis must be filed in the Department office.

Advanced Inorganic Chemistry (Formerly 84.443)

Description

The chemical behavior, structure and methods of preparation and nomenclature of the more common elements and their compounds.

Prerequisites

Co-Req: 84.345 Physical Chemistry II.

Advanced Inorganic Lab (Formerly 84.445)

Description

Laboratory to study the reactions of ions in aqueous solutions and to carry out inorganic syntheses and characterizations.

Prerequisites

Co-req: 84.443 Advanced Inorganic Chemistry.

Introduction To Biochemistry (Formerly 84.450)

Description

An introductory study of the fundamental principles of biochemistry including the chemistry of proteins, carbohydrates, nucleic acids and lipids, thermodynamics, kinetics and mechanisms of enzyme action, intermediary metabolism and selected syllabus in molecular biology.

Prerequisites

Pre-Req: CHEM 2220 Organic Chemistry IIA and Co-Req: CHEM 3440 Physical Chemistry I.

Biochemistry II

Description

A continuation of CHEM.4500 with emphasis on metabolic pathways of amino acids and nucleic acid, biosynthesis of proteins and selected syllabus in molecular biology and various areas of biochemistry. This course will be co-convened with CHEM.5510, the graduate version of Biochemistry II.

Prerequisites

Pre-req: CHEM.4500 Intro to Biochemistry I.

Laboratory in Modern Biochemistry and Biophysics

Description

This is a laboratory course designed to teach basic biochemistry techniques using a series of well-characterized proteins in a research-like setting. The course will meet twice a week throughout the semester. The first half of the semester will be focused on teaching specific biochemical techniques. In the second half of the semester, students will develop an independent research question using protein(s) from a list using the techniques that were learned in the first half of the semester. Students will produce a report using an ACS journal style based on their results and they will also present their results to the class at the end of the semester.

Prerequisites

Pre-req: CHEM.4500 Intro to Biochemistry, or Permission of Instructor.

Advanced Organic Chemistry

Description

This course aims to provide deepened and widened knowledge of concepts, reactivity, and synthesis in organic chemistry. It encompasses: carbonyl/enol/enolate chemistry, frontier molecular orbital theory, pericyclic reactions, rearrangements, fragmentations, reactive intermediates, main group elements (boron, silicon, phosphorous, sulfur, etc.), heterocyclic compounds, organometallic chemistry, stereochemistry, selectivity, catalysis, asymmetric synthesis, and multi-step synthesis.

Prerequisites

Pre-Req: CHEM.2210 Organic Chemistry I, CHEM.2220 Organic Chemistry IIA.

Computational Chemistry

Description

The field of computational chemistry involves the quantitative treatment of the quantum and classical depiction of atoms and molecules. The first part of the class will involve the quantum chemistry approach which will include semi-empirical theory, the Hartree-Fock model, post-Hartree-Fock models, and Density Functional Theory. Quantum chemistry calculations will be performed using the Gaussian software package. The second part will include classical dynamics of molecules using Molecular Mechanics concepts and empirical force-fields. Students will be introduced to numerical algorithms for the calculation of atomic forces and numerical schemes for the integration of Newton's equations of motion. Students will learn how to set up, initialize, and run Molecular Dynamics simulations.

Prerequisites

Pre-Req: CHEM.3440 Physical Chemistry I.

Mon, 17 Aug 2020 21:36:00 -0500 en text/html https://www.uml.edu/Catalog/Undergraduate/Sciences/Departments/Chemistry/Course-Listing.aspx
Killexams : InflaRx Reports Second Quarter 2022 Financial & Operating Results
  • Fast Track and Orphan Drug designation for vilobelimab in pyoderma gangrenosum (PG) granted by the FDA
  • Plans to submit EUA with the FDA for vilobelimab in critically ill COVID-19 patients announced
  • Grant income of €14.4 million realized during the second quarter
  • Cash, cash equivalents and marketable securities of €91.8 million, expected to finance operations until year-end 2024

JENA, Germany, Aug. 05, 2022 (GLOBE NEWSWIRE) -- InflaRx N.V. (Nasdaq: IFRX), a clinical-stage biopharmaceutical company developing anti-inflammatory therapeutics by targeting the complement system, announced today financial and operating results for the three and six months ended June 30, 2022.

“We have made strong progress in accurate months in advancing our strategy for vilobelimab,” said Prof. Niels C. Riedemann, Chief Executive Officer and Founder of InflaRx. “Following positive Phase IIa data and productive discussions with the FDA, we are finalizing the design of our Phase III trial in PG. Our discussions with the FDA related to vilobelimab for the treatment of critically ill, invasively mechanically ventilated COVID-19 patients following the results from our Phase III trial were encouraging. Based on this, we are preparing to apply for emergency use authorization in the U.S. and expect to complete the submission by the end of the third quarter this year. We are also looking forward to further discussing in greater detail our vilobelimab results in critically ill COVID-19 patients with the regulatory agencies in Europe to understand next steps towards a potential submission for marketing authorization. It is a busy time at InflaRx, and we are excited to be moving our programs forward with the goal of ultimately helping patients in need of more effective treatments."

Dr. Thomas Taapken, Chief Financial Officer of InflaRx, said: “We are well financed to follow through with the next steps of our development programs after sharpening our strategic focus, which we announced in May. We are also grateful for the grant of up to €43.7 million from the German federal government for the clinical development of vilobelimab in COVID-19 and the development of the manufacturing process of vilobelimab. Through this strong backing and our focused development strategy, we believe that we have been able to significantly extend our cash runway to YE 2024 in this challenging market environment.”

Recent Corporate and R&amp;D Highlights

Development of Vilobelimab in Pyoderma Gangrenosum (PG):
InflaRx recently reported that vilobelimab was granted orphan drug designation for the treatment of PG by both the U.S. Food and Drug Administration (FDA) and the European Medicines Agency (EMA). In addition, the Company had a productive End-of-Phase II meeting with the FDA related to its plans for a Phase III development program in PG. The FDA indicated its support for a randomized, controlled Phase III development program during the meeting and offered to review the study protocol, recognizing PG as a serious and rare condition. Based on the FDA’s feedback and recommendations, InflaRx is now finalizing the design for a Phase III trial and continues to be in dialogue with the FDA related to this. Moreover, the FDA has granted Fast Track designation for the development of vilobelimab for the treatment of ulcerative PG. The Company had submitted a request for Fast Track designation to the FDA on the basis of previously reported positive outcome data from its Phase IIa open-label dose-escalation study in PG.

Development of Vilobelimab in Critically Ill COVID-19 Patients:
InflaRx recently announced its plans to submit a request for emergency use authorization (EUA) following encouraging interactions with the FDA at a recently held Type B meeting. As previously announced, the Company had requested the meeting to discuss a potential EUA submission and the development of its first-in-class anti-C5a monoclonal antibody vilobelimab in critically ill, invasively mechanically ventilated COVID-19 patients. In the meeting with the FDA, the Company discussed in detail the completed Phase III part of the PANAMO study and obtained guidance from the agency on deliverables related to its planned submission for EUA. InflaRx committed to submitting the request for an EUA by the end of the third quarter 2022 and is dedicated to achieving that ambitious goal. The Company had previously announced encouraging topline 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. The primary efficacy endpoint was 28-day all-cause mortality. In this trial, vilobelimab treatment resulted in a 23.9% relative reduction in 28-day all-cause mortality compared to the placebo arm in the global data set (n=368 patients). A pre-specified analysis of patients from Western European countries (n=209) showed a 43% relative reduction in 28-day all-cause mortality in the vilobelimab treatment arm compared to placebo.

Development of Vilobelimab in Cutaneous Squamous Cell Carcinoma (cSCC):
In 2021, InflaRx started treating patients in 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. To date, InflaRx has recruited nine patients in Arm A of this study (vilobelimab alone). Interim clinical data are expected in the second half of 2022. Arm B of this study (vilobelimab plus pembrolizumab) has enrolled nine patients so far in the first two dose groups. The interim analysis of Arm B is expected once ten patients treated at the dose level recommended by the independent Steering Committee are evaluable for response assessment. These data, which are required to move to the second stage of the Phase II trial, are expected to be available in the second half of 2023.

INF904 – Small Molecule C5aR Inhibitor:
InflaRx expects to initiate a Phase I program in the second half of 2022 and plans to study INF904 in complement-mediated, chronic autoimmune and inflammatory diseases where oral administration is the preferred choice for patients.

Financial Highlights – Q2 2022 

Research and Development Expenses 

Research and development expenses incurred for the six months ended June 30, 2022 increased compared to the corresponding period in 2021 by €5.4 million to €21.7 million. This increase was primarily due to higher expenses for the Phase III part of the COVID-19 trial as well as costs for manufacturing development activities and was driven by an overall increase in third-party expenses of €4.3 million.

General and Administrative Expenses 

General and administrative expenses increased by €3.0 million to €8.7 million for the six months ended June 30, 2022, from €5.7 million for the six months ended June 30, 2021. This increase is primarily attributable to higher expenses associated with equity-settled share-based compensation recognized in personnel expenses. Furthermore, legal, consulting and other expenses increased by €2.0 million to €4.2 million for the six months ended June 30, 2022, from €2.2 million, mainly due to consulting, implementation and testing costs of the internal control over financial reporting (ICFR) environment.

Other income

Other income for the six months ended June 30, 2022 amounted to €14.4 million. This was attributable to income recognized 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 

Net financial result increased by €1.4 million to €2.4 million for the six months ended June 30, 2022, from €1.0 million for the six months ended June 30, 2021. This increase was mainly attributable to lower foreign exchange losses which decreased by €1.4 million.

Net Loss 

Net loss for the six months ended June 30, 2022 was €13.5 million, compared to €20.9 million for the six months ended June 30, 2021.

Net Cash Used in Operating Activities 

Net cash used in operating activities increased by €7.1 million to €25.4 million for the six months ended June 30, 2022 compared to the six months ended June 30, 2021, during which net cash used in operating activities was €18.3 million.

Cash, Cash Equivalents and Marketable Securities

On June 30, 2022, the Company’s total funds available were approximately €91.8 million, composed of cash and cash equivalents of €15.4 million and marketable securities of €76.4 million. These funds are expected to finance operations until year-end 2024.

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, 2022, and the three and six months ended June 30, 2022 and 2021, as well as the consolidated financial statements as of and for the year ended December 31, 2021 in “ITEM 18. Financial Statements,” in InflaRx’s Annual Report on Form 20-F for the year ended December 31, 2021 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 and six months ended June 30, 2022 and 2021

  For the three months ended
June 30,
  For the six months ended
June 30,
(in €, except for share data) 2022
(unaudited)
  2021
(unaudited)
  2022
(unaudited)
  2021
(unaudited)
         
Operating Expenses        
Research and development expenses (11,180,958 )   (11,299,270 )   (21,652,881 )   (16,206,155 )
General and administrative expenses (4,346,965 )   (2,697,839 )   (8,734,408 )   (5,720,177 )
Total Operating Expenses (15,527,923 )   (13,997,109 )   (30,387,289 )   (21,926,332 )
Other income 14,441,541     15,216     14,443,135     20,678  
Other expenses (279 )   (279 )   (844 )   (844 )
Operating Result (1,086,661 )   (13,982,172 )   (15,944,999 )   (21,906,498 )
Finance income 82,401     35,622     110,362     58,584  
Finance expenses (7,945 )   (3,050 )   (32,531 )   (6,734 )
Foreign exchange result 1,563,580     (826,303 )   2,291,513     905,367  
Other financial result (86,000 )   (5,000 )   39,000     43,000  
Income Taxes              
Income (Loss) for the Period 465,376     (14,780,903 )   (13,536,654 )   (20,906,280 )
         
Share Information        
Weighted average number of shares outstanding 44,203,763     44,186,279     44,203,763     39,024,533  
Income (Loss) per share (basic/diluted) 0.01     (0.33 )   (0.31 )   (0.54 )
         
Loss for the Period 465,376     (14.780.903 )   (13,536,654 )   (20,906,280 )
Other comprehensive income (loss) that may be reclassified to profit or loss in subsequent periods:        
Exchange differences on translation of foreign currency 4,408,940     (1,427,302 )   5,718,815     2,077,397  
Total Comprehensive Income (Loss) 4,874,316     (16,208,205 )   (7,817,839 )   (18,828,883 )
         

InflaRx N.V. and subsidiaries

Unaudited Condensed Consolidated Statements of Financial Position as of June 30, 2022 and December 31, 2021

in € June 30, 2022
(unaudited)
    December 31, 2021

 
     
ASSETS    
Non-current assets    
Property and equipment 231,133     274,373  
Right-of-use assets 1,506,039     1,408,078  
Intangible assets 187,218     235,216  
Other assets 341,666     336,566  
Financial assets 237,412     27,206,990  
Total non-current assets 2,503,468     29,461,224  
Current assets    
Current other assets 10,130,597     10,983,458  
Current tax assets 1,518,072     1,282,177  
Financial assets from government grants 8,260,503      
Other financial assets 76,804,249     57,162,266  
Cash and cash equivalents 15,416,152     26,249,995  
Total current assets 112,129,573     95,677,896  
TOTAL ASSETS 114,633,041     125,139,120  
     
EQUITY AND LIABILITIES    
Equity    
Issued capital 5,304,452     5,304,452  
Share premium 280,310,744     280,310,744  
Other capital reserves 35,259,689     30,591,209  
Accumulated deficit (227,512,333 )   (213,975,679 )
Other components of equity 8,769,086     3,050,270  
Total equity 102,131,638     105,280,996  
Non-current liabilities    
Lease liabilities 1,170,237     1,066,354  
Other liabilities 37,733     35,019  
Total non-current liabilities 1,207,970     1,101,373  
Current liabilities    
Trade and other payables 7,912,503     8,574,244  
Liabilities from government grants received 2,145,135     8,300,000  
Lease liabilities 370,153     366,171  
Employee benefits 735,304     1,378,130  
Other financial liabilities 130,338     138,206  
Total current liabilities 11,293,433     18,756,751  
Total Liabilities 12,501,404     19,858,124  
TOTAL EQUITY AND LIABILITIES 114,633,041     125,139,120  
     

InflaRx N.V. and subsidiaries

Unaudited Condensed Consolidated Statements of Changes in Shareholders’ Equity for the six months ended June 30, 2022 and 2021

(in €, except for share data) Issued
capital
  Share
premium
    Other
capital
reserves
  Accumulated
deficit
    Other
components
of equity
    Total
equity
 
                               
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 payment       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  
                               
Balance as of January 1, 2021 3,387,410   220,289,876     26,259,004   (168,345,620 )   (3,726,790 )   77,863,880  
Loss for the period         (20,906,280 )       (20,906,280 )
Exchange differences
on translation of foreign currency
            2,077,397     2,077,397  
Total comprehensive loss         (20,906,280 )   2,077,397     (18,828,883 )
Issuance of common shares and warrants 1,873,203   63,269,346               65,142,549  
Transaction costs   (4,219,222 )             (4,219,222 )
Equity-settled share-based payment       2,687,779           2,687,779  
Share options exercised 41,741   921,994               963,735  
Balance as of June 30, 2021 5,302,354   280,261,994     28,946,783   (189,251,900 )   1,649,393     123,609,838  
                               

InflaRx N.V. and subsidiaries

Unaudited Condensed Consolidated Statements of Cash Flows for the six months ended June 30, 2022 and 2021

in € For the six
months ended
June 30, 2022

(unaudited)
  For the six months
ended June 30,
2021

(unaudited)
     
Operating activities    
Loss for the period (13,536,654 )   (20,906,280 )
Adjustments for:    
Depreciation &amp; amortization of property and equipment, right-of-use assets and intangible assets 300,870     337,581  
Net financial result (2,408,345 )   (1,000,217 )
Share-based payment expense 4,668,481     2,687,779  
Net foreign exchange differences 130,347     71,050  
Changes in:    
Financial assets from government grants (8,260,503 )    
Other assets 611,843     172,001  
Employee benefits (640,112 )   (662,388 )
Other liabilities (7,867 )   7,020  
Liabilities from government grants (6,154,865 )    
Trade and other payables (661,741 )   672,727  
Interest received 631,504     371,665  
Interest paid (32,039 )   (5,491 )
Net cash used in operating activities (25,359,081 )   (18,254,553 )
Investing activities    
Purchase of intangible assets, property and equipment (9,728 )   (18,734 )
Purchase of current financial assets (47,031,216 )   (27,535,842 )
Proceeds from the maturity of financial assets 59,595,044     29,497,122  
Net cash from investing activities 12,554,101     1,942,546  
Financing activities    
Proceeds from issuance of common shares     65,142,549  
Transaction costs from issuance of common shares     (4,219,222 )
Proceeds from exercise of share options     963,735  
Repayment of lease liabilities (182,014 )   (183,128 )
Net cash from (used in) financing activities (182,014 )   61,703,934  
Net decrease/increase in cash and cash equivalents (12,986,995 )   45,391,927  
Effect of exchange rate changes on cash and cash equivalents 2,153,152     999,820  
Cash and cash equivalents at beginning of period 26,249,995     25,968,681  
Cash and cash equivalents at end of period 15,416,152     72,360,428  
     

About InflaRx N.V.:

InflaRx (Nasdaq: IFRX) is a clinical-stage biopharmaceutical company focused on applying its proprietary technology 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 www.inflarx.de.

The COVID-19 related work 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.

e-mail: IR@inflarx.de

MC Services AG

Katja Arnold, Laurie Doyle, Andreas Jungfer
e-mail: inflarx@mc-services.eu
Europe: +49 89-210 2280
US: +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,” “believe,” “estimate,” “predict,” “potential” or “continue” and similar expressions. Forward-looking statements appear in a number of places throughout this release and may include statements regarding InflaRx’s intentions, beliefs, projections, outlook, analyses and current expectations concerning, among other things, the Company’s ongoing and planned pre-clinical development and clinical trials, including the development of vilobelimab to treat pyoderma gangrenosum (PG) and critical COVID-19; the Company’s submission of an application to the FDA in the third quarter of 2022 for emergency use authorization for vilobelimab to treat critically ill COVID-19 patients; the impact of the COVID-19 pandemic on the Company; the timing and its ability to commence and conduct clinical trials; potential results from current or potential future collaborations; its ability to make regulatory filings, obtain positive guidance from regulators, and obtain and maintain regulatory approvals for its product candidates; its intellectual property position; its ability to develop commercial functions; expectations regarding clinical trial data; decisions regarding the strategic direction of the Company; its results of operations, cash needs, financial condition, liquidity, prospects, future transactions, growth and strategies; the industry in which the Company operates; the trends that may affect the industry or the Company; its status as foreign private issuer; 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 the Company’s real 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 InflaRx assumes no obligation to update these forward-looking statements, even if new information becomes available in the future, except as required by law.


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Thu, 04 Aug 2022 23:23:00 -0500 en-US text/html https://ktla.com/business/press-releases/globenewswire/8613295/inflarx-reports-second-quarter-2022-financial-operating-results/
Killexams : InflaRx Receives FDA Fast Track Designation for Treatment of Ulcerative Pyoderma Gangrenosum
  • US Food and Drug Administration awards Fast Track designation for the treatment of ulcerative pyoderma gangrenosum
  • Fast track follows recently reported orphan drug designation by both US FDA and EMA

JENA, Germany, July 06, 2022 (GLOBE NEWSWIRE) -- InflaRx N.V. (Nasdaq: IFRX), a clinical-stage biopharmaceutical company developing anti-inflammatory therapeutics by targeting the complement system, today announced that the US Food and Drug Administration (FDA) granted a Fast Track designation to the development of its first-in-class anti-C5a monoclonal antibody vilobelimab for the treatment of ulcerative pyoderma gangrenosum (PG). The Company had submitted a request for Fast Track designation to the FDA on the positive outcome data in PG from its Phase IIa open-label dose-escalation study.

As previously announced, in the multi-center, proof-of-concept Phase IIa study a total of 19 patients were enrolled. Over a treatment period of 26 weeks, patients were treated biweekly with vilobelimab 800mg, 1600mg or 2400mg, after an initial run-in phase with three doses of 800mg on days 1, 4 and 8, followed by a two-month observation period. Efficacy was assessed with the physician global assessment score (PGA), and 6 out of 7 patients (85.7%) in the high dose cohort demonstrated complete target ulcer closure and treatment response correlated with suppression of C5a levels in patients’ plasma over time.

The Company had previously announced that vilobelimab was granted orphan drug designation for the treatment of PG by both the FDA in the US and the European Medicines Agency (EMA) in Europe and that the Company had held a productive End-of-Phase II meeting with the Division of Dermatology with the FDA related to its Phase III development plans in PG.

“We are pleased that our development in pyoderma gangrenosum has been designated Fast Track by the FDA shortly after receiving the Orphan Drug designation, recognizing PG as serious condition with high unmet medical need and vilobelimab as promising potential future treatment option,” said Prof. Niels C. Riedemann, CEO and Founder of InflaRx. “The Fast Track designation will further facilitate our interactions with the FDA related to our development in PG and will also allow for faster review and approval upon successful completion of a Phase III development program,” he added.

About Fast Track1

Fast track is a process designed by the FDA to facilitate the development and expedite the review of drugs to treat serious conditions and fill an unmet medical need. According to the FDA, the purpose is to get important new drugs to the patient earlier. A drug that receives Fast Track designation is eligible for some or all of the following:

  • more frequent meetings with FDA to discuss the drug's development plan and ensure collection of appropriate data needed to support drug approval;
  • more frequent written communication from FDA about such things as the design of the proposed clinical trials and use of biomarkers;
  • eligibility for Accelerated Approval and Priority Review, if relevant criteria are met; and
  • Rolling Review, which means that a drug company can submit completed sections of its Biologic License Application (BLA) or New Drug Application (NDA) for review by FDA, rather than waiting until every section of the NDA is completed before the entire application can be reviewed.

About Vilobelimab

Vilobelimab is a first-in-class monoclonal anti-human complement factor C5a antibody, which highly and effectively blocks the biological activity of C5a and demonstrates high selectivity towards its target in human blood. Thus, vilobelimab leaves the formation of the membrane attack complex (C5b-9) intact as an important defense mechanism, which is not the case for molecules blocking the cleavage of C5. Vilobelimab has been demonstrated in pre-clinical studies to control the inflammatory response driven tissue and organ damage by specifically blocking C5a as a key “amplifier” of this response. Vilobelimab is believed to be the first monoclonal anti-C5a antibody introduced into clinical development. Vilobelimab has been shown to be well tolerated within clinical trials in different disease settings. Vilobelimab is currently being developed for various indications, including pyoderma gangrenosum and severe COVID-19. The Company has recently reported positive Phase IIa results in PG and encouraging Phase III results in mechanically ventilated COVID-19 patients. Vilobelimab is also in Phase II development for patients suffering from cutaneous squamous cell carcinoma.

About InflaRx N.V.

InflaRx (Nasdaq: IFRX) is a clinical-stage biopharmaceutical company focused on applying its proprietary technology to discover and develop first-in-class or best-in-class, potent and specific inhibitors of C5a and C5aR. Complement C5a and 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 www.inflarx.com.

Contacts:

InflaRx N.V. 
Email: IR@inflarx.de

MC Services AG
Katja Arnold, Laurie Doyle, Andreas Jungfer
Email: inflarx@mc-services.eu 
Europe: +49 89-210 2280
US: +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,” “believe,” “estimate,” “predict,” “potential” or “continue” and similar expressions. 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 ongoing and planned pre-clinical development and clinical trials, including the development of vilobelimab to treat pyoderma gangrenosum (PG) and severe COVID-19; the impact of the COVID-19 pandemic on us; the timing and our ability to commence and conduct clinical trials; potential results from current or potential future collaborations; our ability to make regulatory filings, obtain positive guidance from regulators, and obtain and maintain regulatory approvals for our product candidates; our intellectual property position; our ability to develop commercial functions; expectations regarding clinical trial data; our results of operations, cash needs, financial condition, liquidity, prospects, future transactions, growth and strategies; the industry in which we operate; the trends that may affect the industry or us; our status as a foreign private issuer; and the risks, uncertainties and other factors described under the heading “Risk Factors” in InflaRx’s periodic filings with the Securities and Exchange Commission. 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 real 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.

___________________________

1  See U.S. Food and Drug Administration, “Fast Track,” available online. 


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Tue, 05 Jul 2022 23:57:00 -0500 en-US text/html https://ktla.com/business/press-releases/globenewswire/8584459/inflarx-receives-fda-fast-track-designation-for-treatment-of-ulcerative-pyoderma-gangrenosum/
Killexams : Cancer Research UK and Sosei Heptares sign agreement to advance cancer immunotherapy candidate into clinical trials

TOKYO, Japan and LONDON and CAMBRIDGE, United Kingdom, July 22, 2022 (GLOBE NEWSWIRE) -- Sosei Group Corporation (“the Company”; TSE: 4565), an international biopharmaceutical company and world-leader in GPCR1-focused structure-based drug design (SBDD) and development, and Cancer Research UK, the world’s largest private funder of cancer research, today announce the signing of an agreement to bring Sosei Heptares’ cancer immunotherapy drug candidate into a first-in-human trial.

Under the Clinical Trial and Licence Agreement (CTLA), Cancer Research UK’s Centre for Drug Development will sponsor, design and execute a Phase I/IIa clinical trial of HTL00397322, a novel selective EP4 antagonist.

Sosei Heptares will be responsible for CTA enabling activities, including GLP toxicology, IMP manufacture1 and other necessary pre-clinical studies in preparation for the opening of the clinical trial. Sosei Heptares holds a licence to the results generated under the trial to continue the clinical development and commercialisation of HTL0039732.

HTL0039732 has been proposed for a range of cancers including microsatellite stable3 colorectal, gastroesophageal, head and neck and castrate resistant prostate cancer.

Many people with these types of cancer have missed out on the benefits that common immunotherapies, such as PD1/L1 checkpoint inhibitors4, have brought to other cancer types. The hope is that this trial could find that HTL0039732 is an effective immunotherapy for these under-served patient populations.

HTL0039732 is a type of immunotherapy known as an EP4 antagonist, which means it selectively binds and blocks a specific type of prostaglandin receptor5 called EP4. Prostaglandin E2 (PGE2) mediated signalling through EP4 can trigger cancer cells to evade the immune system and can also influence tumour cell growth. Therefore, blocking this type of receptor may Improve patient survival, especially if used in combination with another immunotherapy.

The Director of Cancer Research UK’s Centre for Drug Development, Dr Nigel Blackburn, said: “People with these cancer types have, to date, largely missed out on some of the remarkable advances in the field of immunotherapy.

"We are therefore thrilled to be partnering with Sosei Heptares to bring their novel immunotherapy candidate into human trials. The hope is that with more trials like this, all cancer patients will eventually be able to benefit from this potentially life-saving form of cancer treatment.”

Matt Barnes, President of Heptares Therapeutics and Head of UK R&amp;D, commented: “We are extremely pleased to collaborate with Cancer Research UK to advance HTL0039732 into Phase I/IIa clinical trials and take a step towards bringing new treatments to cancer patients.

“HTL0039732 was rationally designed using our highly productive SBDD platform specifically for this type of immunotherapy approach and as such we believe it offers the potential to be a best-in-class EP4 antagonist agent.”

Notes to Editors

Further details of HTL0039732 will be presented at the 2022 Medicinal Chemistry Gordon Research Conference in early August 2022.

1GPCRs (G Protein-Coupled Receptors) are a super-family of integral cell membrane proteins that are present on cells and tissues throughout the body. GPCRs are involved in signalling pathways that influence a wide range of biological processes and are important drug targets implicated in many human diseases and disorders. CTA – Clinical Trial Authorisation; GLP – Good Laboratory Practice; IMP – Investigational Medicinal Product

2HTL0039732 will be evaluated as both a combination therapy and a monotherapy

3Approximately 80-85% of colorectal cancer patients are classified as ‘Microsatellite Stable’ which means they have low instability in short, repeated sequences of DNA in their tumours, known as microsatellites. MSS tumors often exist in an environment that suppresses the immune system and do not respond well to immunotherapies.

4Checkpoint inhibitors block proteins, known as checkpoint proteins, that stop the immune system from attacking the cancer cells. Examples of checkpoint inhibitors include pembrolizumab (Keytruda), ipilimumab (Yervoy), nivolumab (Opdivo) and atezolizumab (Tecentriq).

5The prostaglandins are a group of lipids made at sites of tissue damage or infection that are involved in dealing with injury and illness. They control processes such as inflammation, blood flow, the formation of blood clots and the induction of labor.

About Cancer Research UK’s Centre for Drug Development
Cancer Research UK has an impressive record of developing novel treatments for cancer. The Cancer Research UK Centre for Drug Development has been pioneering the development of new cancer treatments for 25 years, taking over 140 potential new anti-cancer agents into clinical trials in patients. It currently has a portfolio of 21 new anti-cancer agents in preclinical development, Phase I or early Phase IIa clinical trials. Six of these new agents have made it to market including temozolomide for brain cancer, abiraterone for prostate cancer and rucaparib for ovarian cancer. Two other drugs are in late development Phase III trials. www.cruk.org.uk/cdd   

About Cancer Research UK

  • Cancer Research UK is the world’s leading cancer charity dedicated to saving lives through research.
  • Cancer Research UK’s pioneering work into the prevention, diagnosis and treatment of cancer has helped save millions of lives.
  • Cancer Research UK receives no funding from the UK government for its life-saving research. Every step it makes towards beating cancer relies on vital donations from the public.
  • Cancer Research UK has been at the heart of the progress that has already seen survival in the UK double in the last 40 years.
  • Today, 2 in 4 people survive their cancer for at least 10 years. Cancer Research UK’s ambition is to accelerate progress so that by 2034, 3 in 4 people will survive their cancer for at least 10 years.
  • Cancer Research UK supports research into all aspects of cancer through the work of over 4,000 scientists, doctors and nurses.
  • Together with its partners and supporters, Cancer Research UK's vision is to bring forward the day when all cancers are cured.

For further information about Cancer Research UK's work or to find out how to support the charity, please call +44 (0)300 123 1022 or visit www.cancerresearchuk.org. Follow us on Twitter and Facebook.

About Sosei Heptares

We are an international biopharmaceutical group focused on the discovery and early development of new medicines originating from our proprietary GPCR-targeted StaR® technology and structure-based drug design platform capabilities. We are advancing a broad and deep pipeline of novel medicines across multiple therapeutic areas, including neurology, immunology, gastroenterology and inflammatory diseases.

We have established partnerships with some of the world’s leading pharmaceutical companies and multiple emerging technology companies, including AbbVie, AstraZeneca, Biohaven, Genentech (Roche), GSK, Neurocrine Biosciences, Novartis, Pfizer, Takeda and Verily. Sosei Heptares is headquartered in Tokyo, Japan with corporate and R&amp;D facilities in Cambridge, UK.

“Sosei Heptares” is the corporate brand and trademark of Sosei Group Corporation, which is listed on the Tokyo Stock Exchange (ticker: 4565). Sosei, Heptares, the logo and StaR® are trademarks of Sosei Group companies.

For more information, please visit https://soseiheptares.com/
LinkedIn: @soseiheptaresco | Twitter: @soseiheptaresco | YouTube: @soseiheptaresco

Enquiries:

Cancer Research UK
Ellie Bennett, Media Officer
+44 (0)20 3469 5370 or, out of hours, on +44 (0)7884 466 868 | eleanor.bennett@cancer.org.uk

Sosei Heptares – Media and Investor Relations
Hironoshin Nomura, Chief Financial Officer
Shinichiro Nishishita, VP Investor Relations, Head of Regulatory Disclosures
Candelle Chong, SVP Investor Relations and Corporate Strategy
Japan: +81 (0)3 5210 3399 | United Kingdom: +44 (0)1223 949390 | IR@SoseiHeptares.com

MEDiSTRAVA Consulting (for International Media)
Mark Swallow, Frazer Hall, Eleanor Perkin
+44 (0)203 928 6900| SoseiHeptares@medistrava.com

Sosei Heptares Forward-looking statements
This press release contains forward-looking statements, including statements about the discovery, development and commercialization of products. Various risks may cause Sosei Group Corporation’s real results to differ materially from those expressed or implied by the forward-looking statements, including: adverse results in clinical development programs; failure to obtain patent protection for inventions; commercial limitations imposed by patents owned or controlled by third parties; dependence upon strategic alliance partners to develop and commercialize products and services; difficulties or delays in obtaining regulatory approvals to market products and services resulting from development efforts; the requirement for substantial funding to conduct research and development and to expand commercialization activities; and product initiatives by competitors. As a result of these factors, prospective investors are cautioned not to rely on any forward-looking statements. We disclaim any intention or obligation to update or revise any forward-looking statements, whether as a result of new information, future events or otherwise.


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Killexams : InflaRx Reports Second Quarter 2022 Financial & Operating Results

InflaRx N.V.

  • Fast Track and Orphan Drug designation for vilobelimab in pyoderma gangrenosum (PG) granted by the FDA

  • Plans to submit EUA with the FDA for vilobelimab in critically ill COVID-19 patients announced

  • Grant income of €14.4 million realized during the second quarter

  • Cash, cash equivalents and marketable securities of €91.8 million, expected to finance operations until year-end 2024

JENA, Germany, Aug. 05, 2022 (GLOBE NEWSWIRE) -- InflaRx N.V. (Nasdaq: IFRX), a clinical-stage biopharmaceutical company developing anti-inflammatory therapeutics by targeting the complement system, announced today financial and operating results for the three and six months ended June 30, 2022.

“We have made strong progress in accurate months in advancing our strategy for vilobelimab,” said Prof. Niels C. Riedemann, Chief Executive Officer and Founder of InflaRx. “Following positive Phase IIa data and productive discussions with the FDA, we are finalizing the design of our Phase III trial in PG. Our discussions with the FDA related to vilobelimab for the treatment of critically ill, invasively mechanically ventilated COVID-19 patients following the results from our Phase III trial were encouraging. Based on this, we are preparing to apply for emergency use authorization in the U.S. and expect to complete the submission by the end of the third quarter this year. We are also looking forward to further discussing in greater detail our vilobelimab results in critically ill COVID-19 patients with the regulatory agencies in Europe to understand next steps towards a potential submission for marketing authorization. It is a busy time at InflaRx, and we are excited to be moving our programs forward with the goal of ultimately helping patients in need of more effective treatments."

Dr. Thomas Taapken, Chief Financial Officer of InflaRx, said: “We are well financed to follow through with the next steps of our development programs after sharpening our strategic focus, which we announced in May. We are also grateful for the grant of up to €43.7 million from the German federal government for the clinical development of vilobelimab in COVID-19 and the development of the manufacturing process of vilobelimab. Through this strong backing and our focused development strategy, we believe that we have been able to significantly extend our cash runway to YE 2024 in this challenging market environment.”

Recent Corporate and R&amp;D Highlights

Development of Vilobelimab in Pyoderma Gangrenosum (PG):
InflaRx recently reported that vilobelimab was granted orphan drug designation for the treatment of PG by both the U.S. Food and Drug Administration (FDA) and the European Medicines Agency (EMA). In addition, the Company had a productive End-of-Phase II meeting with the FDA related to its plans for a Phase III development program in PG. The FDA indicated its support for a randomized, controlled Phase III development program during the meeting and offered to review the study protocol, recognizing PG as a serious and rare condition. Based on the FDA’s feedback and recommendations, InflaRx is now finalizing the design for a Phase III trial and continues to be in dialogue with the FDA related to this. Moreover, the FDA has granted Fast Track designation for the development of vilobelimab for the treatment of ulcerative PG. The Company had submitted a request for Fast Track designation to the FDA on the basis of previously reported positive outcome data from its Phase IIa open-label dose-escalation study in PG.

Development of Vilobelimab in Critically Ill COVID-19 Patients:
InflaRx recently announced its plans to submit a request for emergency use authorization (EUA) following encouraging interactions with the FDA at a recently held Type B meeting. As previously announced, the Company had requested the meeting to discuss a potential EUA submission and the development of its first-in-class anti-C5a monoclonal antibody vilobelimab in critically ill, invasively mechanically ventilated COVID-19 patients. In the meeting with the FDA, the Company discussed in detail the completed Phase III part of the PANAMO study and obtained guidance from the agency on deliverables related to its planned submission for EUA. InflaRx committed to submitting the request for an EUA by the end of the third quarter 2022 and is dedicated to achieving that ambitious goal. The Company had previously announced encouraging topline 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. The primary efficacy endpoint was 28-day all-cause mortality. In this trial, vilobelimab treatment resulted in a 23.9% relative reduction in 28-day all-cause mortality compared to the placebo arm in the global data set (n=368 patients). A pre-specified analysis of patients from Western European countries (n=209) showed a 43% relative reduction in 28-day all-cause mortality in the vilobelimab treatment arm compared to placebo.

Development of Vilobelimab in Cutaneous Squamous Cell Carcinoma (cSCC):
In 2021, InflaRx started treating patients in 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. To date, InflaRx has recruited nine patients in Arm A of this study (vilobelimab alone). Interim clinical data are expected in the second half of 2022. Arm B of this study (vilobelimab plus pembrolizumab) has enrolled nine patients so far in the first two dose groups. The interim analysis of Arm B is expected once ten patients treated at the dose level recommended by the independent Steering Committee are evaluable for response assessment. These data, which are required to move to the second stage of the Phase II trial, are expected to be available in the second half of 2023.

INF904 – Small Molecule C5aR Inhibitor:
InflaRx expects to initiate a Phase I program in the second half of 2022 and plans to study INF904 in complement-mediated, chronic autoimmune and inflammatory diseases where oral administration is the preferred choice for patients.

Financial Highlights – Q2 2022 

Research and Development Expenses 

Research and development expenses incurred for the six months ended June 30, 2022 increased compared to the corresponding period in 2021 by €5.4 million to €21.7 million. This increase was primarily due to higher expenses for the Phase III part of the COVID-19 trial as well as costs for manufacturing development activities and was driven by an overall increase in third-party expenses of €4.3 million.

General and Administrative Expenses 

General and administrative expenses increased by €3.0 million to €8.7 million for the six months ended June 30, 2022, from €5.7 million for the six months ended June 30, 2021. This increase is primarily attributable to higher expenses associated with equity-settled share-based compensation recognized in personnel expenses. Furthermore, legal, consulting and other expenses increased by €2.0 million to €4.2 million for the six months ended June 30, 2022, from €2.2 million, mainly due to consulting, implementation and testing costs of the internal control over financial reporting (ICFR) environment.

Other income

Other income for the six months ended June 30, 2022 amounted to €14.4 million. This was attributable to income recognized 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 

Net financial result increased by €1.4 million to €2.4 million for the six months ended June 30, 2022, from €1.0 million for the six months ended June 30, 2021. This increase was mainly attributable to lower foreign exchange losses which decreased by €1.4 million.

Net Loss 

Net loss for the six months ended June 30, 2022 was €13.5 million, compared to €20.9 million for the six months ended June 30, 2021.

Net Cash Used in Operating Activities 

Net cash used in operating activities increased by €7.1 million to €25.4 million for the six months ended June 30, 2022 compared to the six months ended June 30, 2021, during which net cash used in operating activities was €18.3 million.

Cash, Cash Equivalents and Marketable Securities

On June 30, 2022, the Company’s total funds available were approximately €91.8 million, composed of cash and cash equivalents of €15.4 million and marketable securities of €76.4 million. These funds are expected to finance operations until year-end 2024.

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, 2022, and the three and six months ended June 30, 2022 and 2021, as well as the consolidated financial statements as of and for the year ended December 31, 2021 in “ITEM 18. Financial Statements,” in InflaRx’s Annual Report on Form 20-F for the year ended December 31, 2021 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 and six months ended June 30, 2022 and 2021

For the three months ended
June 30,

For the six months ended
June 30,

(in €, except for share data)

2022
(unaudited)

2021
(unaudited)

2022
(unaudited)

2021
(unaudited)

Operating Expenses

Research and development expenses

(11,180,958

)

(11,299,270

)

(21,652,881

)

(16,206,155

)

General and administrative expenses

(4,346,965

)

(2,697,839

)

(8,734,408

)

(5,720,177

)

Total Operating Expenses

(15,527,923

)

(13,997,109

)

(30,387,289

)

(21,926,332

)

Other income

14,441,541

15,216

14,443,135

20,678

Other expenses

(279

)

(279

)

(844

)

(844

)

Operating Result

(1,086,661

)

(13,982,172

)

(15,944,999

)

(21,906,498

)

Finance income

82,401

35,622

110,362

58,584

Finance expenses

(7,945

)

(3,050

)

(32,531

)

(6,734

)

Foreign exchange result

1,563,580

(826,303

)

2,291,513

905,367

Other financial result

(86,000

)

(5,000

)

39,000

43,000

Income Taxes

Income (Loss) for the Period

465,376

(14,780,903

)

(13,536,654

)

(20,906,280

)

Share Information

Weighted average number of shares outstanding

44,203,763

44,186,279

44,203,763

39,024,533

Income (Loss) per share (basic/diluted)

0.01

(0.33

)

(0.31

)

(0.54

)

Loss for the Period

465,376

(14.780.903

)

(13,536,654

)

(20,906,280

)

Other comprehensive income (loss) that may be reclassified to profit or loss in subsequent periods:

Exchange differences on translation of foreign currency

4,408,940

(1,427,302

)

5,718,815

2,077,397

Total Comprehensive Income (Loss)

4,874,316

(16,208,205

)

(7,817,839

)

(18,828,883

)

InflaRx N.V. and subsidiaries

Unaudited Condensed Consolidated Statements of Financial Position as of June 30, 2022 and December 31, 2021

in €

June 30, 2022
(unaudited)

December 31, 2021

ASSETS

Non-current assets

Property and equipment

231,133

274,373

Right-of-use assets

1,506,039

1,408,078

Intangible assets

187,218

235,216

Other assets

341,666

336,566

Financial assets

237,412

27,206,990

Total non-current assets

2,503,468

29,461,224

Current assets

Current other assets

10,130,597

10,983,458

Current tax assets

1,518,072

1,282,177

Financial assets from government grants

8,260,503

Other financial assets

76,804,249

57,162,266

Cash and cash equivalents

15,416,152

26,249,995

Total current assets

112,129,573

95,677,896

TOTAL ASSETS

114,633,041

125,139,120

EQUITY AND LIABILITIES

Equity

Issued capital

5,304,452

5,304,452

Share premium

280,310,744

280,310,744

Other capital reserves

35,259,689

30,591,209

Accumulated deficit

(227,512,333

)

(213,975,679

)

Other components of equity

8,769,086

3,050,270

Total equity

102,131,638

105,280,996

Non-current liabilities

Lease liabilities

1,170,237

1,066,354

Other liabilities

37,733

35,019

Total non-current liabilities

1,207,970

1,101,373

Current liabilities

Trade and other payables

7,912,503

8,574,244

Liabilities from government grants received

2,145,135

8,300,000

Lease liabilities

370,153

366,171

Employee benefits

735,304

1,378,130

Other financial liabilities

130,338

138,206

Total current liabilities

11,293,433

18,756,751

Total Liabilities

12,501,404

19,858,124

TOTAL EQUITY AND LIABILITIES

114,633,041

125,139,120

InflaRx N.V. and subsidiaries

Unaudited Condensed Consolidated Statements of Changes in Shareholders’ Equity for the six months ended June 30, 2022 and 2021

(in €, except for share data)

Issued
capital

Share
premium

Other
capital
reserves

Accumulated
deficit

Other
components
of equity

Total
equity

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 payment

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

Balance as of January 1, 2021

3,387,410

220,289,876

26,259,004

(168,345,620

)

(3,726,790

)

77,863,880

Loss for the period

(20,906,280

)

(20,906,280

)

Exchange differences
on translation of foreign currency

2,077,397

2,077,397

Total comprehensive loss

(20,906,280

)

2,077,397

(18,828,883

)

Issuance of common shares and warrants

1,873,203

63,269,346

65,142,549

Transaction costs

(4,219,222

)

(4,219,222

)

Equity-settled share-based payment

2,687,779

2,687,779

Share options exercised

41,741

921,994

963,735

Balance as of June 30, 2021

5,302,354

280,261,994

28,946,783

(189,251,900

)

1,649,393

123,609,838

InflaRx N.V. and subsidiaries

Unaudited Condensed Consolidated Statements of Cash Flows for the six months ended June 30, 2022 and 2021

in €

For the six
months ended
June 30, 2022

(unaudited)

For the six months
ended June 30,
2021

(unaudited)

Operating activities

Loss for the period

(13,536,654

)

(20,906,280

)

Adjustments for:

Depreciation &amp; amortization of property and equipment, right-of-use assets and intangible assets

300,870

337,581

Net financial result

(2,408,345

)

(1,000,217

)

Share-based payment expense

4,668,481

2,687,779

Net foreign exchange differences

130,347

71,050

Changes in:

Financial assets from government grants

(8,260,503

)

Other assets

611,843

172,001

Employee benefits

(640,112

)

(662,388

)

Other liabilities

(7,867

)

7,020

Liabilities from government grants

(6,154,865

)

Trade and other payables

(661,741

)

672,727

Interest received

631,504

371,665

Interest paid

(32,039

)

(5,491

)

Net cash used in operating activities

(25,359,081

)

(18,254,553

)

Investing activities

Purchase of intangible assets, property and equipment

(9,728

)

(18,734

)

Purchase of current financial assets

(47,031,216

)

(27,535,842

)

Proceeds from the maturity of financial assets

59,595,044

29,497,122

Net cash from investing activities

12,554,101

1,942,546

Financing activities

Proceeds from issuance of common shares

65,142,549

Transaction costs from issuance of common shares

(4,219,222

)

Proceeds from exercise of share options

963,735

Repayment of lease liabilities

(182,014

)

(183,128

)

Net cash from (used in) financing activities

(182,014

)

61,703,934

Net decrease/increase in cash and cash equivalents

(12,986,995

)

45,391,927

Effect of exchange rate changes on cash and cash equivalents

2,153,152

999,820

Cash and cash equivalents at beginning of period

26,249,995

25,968,681

Cash and cash equivalents at end of period

15,416,152

72,360,428

About InflaRx N.V.:

InflaRx (Nasdaq: IFRX) is a clinical-stage biopharmaceutical company focused on applying its proprietary technology 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 www.inflarx.de.

The COVID-19 related work 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.

e-mail: IR@inflarx.de

MC Services AG

Katja Arnold, Laurie Doyle, Andreas Jungfer
e-mail: inflarx@mc-services.eu
Europe: +49 89-210 2280
US: +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,” “believe,” “estimate,” “predict,” “potential” or “continue” and similar expressions. Forward-looking statements appear in a number of places throughout this release and may include statements regarding InflaRx’s intentions, beliefs, projections, outlook, analyses and current expectations concerning, among other things, the Company’s ongoing and planned pre-clinical development and clinical trials, including the development of vilobelimab to treat pyoderma gangrenosum (PG) and critical COVID-19; the Company’s submission of an application to the FDA in the third quarter of 2022 for emergency use authorization for vilobelimab to treat critically ill COVID-19 patients; the impact of the COVID-19 pandemic on the Company; the timing and its ability to commence and conduct clinical trials; potential results from current or potential future collaborations; its ability to make regulatory filings, obtain positive guidance from regulators, and obtain and maintain regulatory approvals for its product candidates; its intellectual property position; its ability to develop commercial functions; expectations regarding clinical trial data; decisions regarding the strategic direction of the Company; its results of operations, cash needs, financial condition, liquidity, prospects, future transactions, growth and strategies; the industry in which the Company operates; the trends that may affect the industry or the Company; its status as foreign private issuer; 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 the Company’s real 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 InflaRx assumes no obligation to update these forward-looking statements, even if new information becomes available in the future, except as required by law.

Fri, 05 Aug 2022 03:53:00 -0500 en-GB text/html https://uk.sports.yahoo.com/news/inflarx-reports-second-quarter-2022-110000390.html
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