Penem

Iterum Therapeutics Reports Inducement Grant Under Nasdaq Listing Rule 5635(c)(4)

Retrieved on: 
Tuesday, December 14, 2021
Therapy, QIDP, Bacteria, Company, Nasdaq, IV, GLOBE, ITRM, Infection, Penem, Employment, Pharmaceutical industry

This grant was awarded pursuant to the Nasdaq inducement grant exception as a component of new hire employment compensation.

Key Points: 
  • This grant was awarded pursuant to the Nasdaq inducement grant exception as a component of new hire employment compensation.
  • The share option was granted effective December 10, 2021 with an exercise price of $0.48 per share, which is equal to the closing price of Iterum Therapeutics ordinary shares on the date of grant.
  • The share option and restricted share unit awards were approved by Iterum Therapeutics Compensation Committee and were granted as an inducement material to Dr. Puttaguntas acceptance of employment in accordance with Nasdaq Listing Rule 5635(c)(4).
  • Iterum Therapeutics has received Qualified Infectious Disease Product (QIDP) and Fast Track designations for its oral and IV formulations of sulopenem in seven indications.

Iterum Therapeutics Appoints Sailaja Puttagunta, MD as Chief Medical Officer

Retrieved on: 
Monday, December 13, 2021
Phrase, Therapy, Forward-looking statement, U.S. Securities and Exchange Commission, Hand, QIDP, Public policy, Company, Bacteria, Gandhi Medical College, Industry, Nasdaq, COVID-19, Drug, SEC, Infection, Research, Internal medicine, Security (finance), IV, Yale School of Medicine, Legislation, GLOBE, ITRM, Medical school, Pfizer, Penem, Pharmaceutical industry, Biochemistry, Medicine

We are thrilled that Sailaja is back at Iterum given her strong industry and operational leadership at a time when oral sulopenem is re-entering the clinic, saidCorey Fishman, Chief Executive Officer of Iterum.

Key Points: 
  • We are thrilled that Sailaja is back at Iterum given her strong industry and operational leadership at a time when oral sulopenem is re-entering the clinic, saidCorey Fishman, Chief Executive Officer of Iterum.
  • Sailaja has deep experience in antibiotic drug development, including having previously worked on sulopenem at both Iterum and Pfizer Inc., which will prove invaluable for our clinical development and registration strategies.
  • Im excited to rejoin Iterum at this time of important advancement for the Company, said Dr. Puttagunta.
  • Most recently Dr. Puttagunta served as Chief Medical Officer at BiomX Inc., a public biotechnology company.

Iterum Therapeutics Reports Third Quarter 2021 Financial Results and Provides Business Update

Retrieved on: 
Friday, November 12, 2021
NDA, Legislation, Corporation, Maturity, Urinary tract infection, G&A, Finance Secretary (India), Therapy, Clinical trial, Security (finance), Exchangeable, Nasdaq, Hand, Penem, Endpoint security, Food, Senior, Investment, Phrase, COVID-19, IV, Forward-looking statement, Regulation of tobacco by the U.S. Food and Drug Administration, Table, QIDP, CRL, Bacteria, Public policy, Conference, U.S. Securities and Exchange Commission, Research, GLOBE, Infection, GAAP, SEC, Note, FDA, ITRM, Pharmaceutical industry, Lithium, Internet service provider, Bank

DUBLIN, Ireland and CHICAGO, Nov. 12, 2021 (GLOBE NEWSWIRE) -- Iterum Therapeutics plc (Nasdaq: ITRM), a clinical-stage pharmaceutical company focused on developing next generation oral and IV antibiotics to treat infections caused by multi-drug resistant pathogens in both community and hospital settings, today reported financial results for the third quarter ended September 30, 2021.

Key Points: 
  • As of September 30, 2021, Iterum had cash, cash equivalents and short-term investments of $85.7 million.
  • Research and development expenses for the third quarter of 2021 were $1.8 million compared to $3.9 million for the same period in 2020.
  • General and administrative (G&A) expenses for the third quarter of 2021 were $3.0 million compared to $2.4 million for the same period in 2020.
  • Iterum reported a non-GAAP1 net loss of $5.2 million for the third quarter of 2021 compared to a non-GAAP net loss of $7.0 million for the same period in 2020.

Iterum Therapeutics to Provide Business Update and Report Third Quarter 2021 Financial Results on November 12, 2021

Retrieved on: 
Friday, November 5, 2021
Legislation, Therapy, Investor, Security (finance), Hand, Penem, Endpoint security, Phrase, COVID-19, IV, Forward-looking statement, QIDP, Bacteria, Public policy, Company, U.S. Securities and Exchange Commission, GLOBE, Infection, SEC, Access, Nasdaq, ITRM, Pharmaceutical industry

Management will host a conference call at8:30 a.m. ETthat day to discuss the Companys financial results and provide an update on its business.

Key Points: 
  • Management will host a conference call at8:30 a.m. ETthat day to discuss the Companys financial results and provide an update on its business.
  • To access the call please dial 844-200-6205 (domestic) or 929-526-1599 (international) and refer to Access Code 442364.
  • The audio webcast can be accessed under Financials & Filings in the Investors section of the Companys website at www.iterumtx.com following the call.
  • Iterum is currently advancing its first compound, sulopenem, a novel penem anti-infective compound, in Phase 3 clinical development with an oral formulation.

Iterum Therapeutics Provides Update from FDA Type A Meeting Regarding Oral Sulopenem

Retrieved on: 
Tuesday, September 28, 2021
Food, Endpoint security, Therapy, Hand, NDA, Regulation of food and dietary supplements by the U.S. Food and Drug Administration, Infection, Security (finance), CRL, Urinary tract infection, U.S. Securities and Exchange Commission, FDA, IV, ITRM, Adult, Bacteria, Phrase, Public policy, Penem, Legislation, New Drug Application, Company, Woman, COVID-19, Forward-looking statement, QIDP, Investment, Nasdaq, SEC, GLOBE, Pharmaceutical industry

In July, the Company announced that it had received a Complete Response Letter (CRL) from the FDA requesting additional data to support approval of oral sulopenem for the treatment of adult women with a uUTI.

Key Points: 
  • In July, the Company announced that it had received a Complete Response Letter (CRL) from the FDA requesting additional data to support approval of oral sulopenem for the treatment of adult women with a uUTI.
  • We continue to believe in the ability of sulopenem to treat the growing problem of multi-drug resistant UTIs in the community.
  • Iterum Therapeutics is advancing its first compound, sulopenem, a novel penem anti-infective compound, in Phase 3 clinical development with an oral formulation and IV formulation.
  • Iterum Therapeutics has received Qualified Infectious Disease Product (QIDP) and Fast Track designations for its oral and IV formulations of sulopenem in seven indications.

Iterum Therapeutics to Present Data at IDWeek 2021

Retrieved on: 
Tuesday, September 28, 2021
Therapy, Hand, NDA, Security (finance), Infection, Infectious Diseases Society of America, CRL, U.S. Securities and Exchange Commission, IV, ITRM, Bacteria, Phrase, Public policy, Penem, Legislation, Company, COVID-19, IDSA, Forward-looking statement, QIDP, Nasdaq, SEC, GLOBE, Pharmaceutical industry

Iterum Therapeutics plc is a clinical-stage pharmaceutical company dedicated to developing differentiated anti-infectives aimed at combatting the global crisis of multi-drug resistant pathogens to significantly improve the lives of people affected by serious and life-threatening diseases around the world.

Key Points: 
  • Iterum Therapeutics plc is a clinical-stage pharmaceutical company dedicated to developing differentiated anti-infectives aimed at combatting the global crisis of multi-drug resistant pathogens to significantly improve the lives of people affected by serious and life-threatening diseases around the world.
  • Iterum Therapeutics is advancing its first compound, sulopenem, a novel penem anti-infective compound, in Phase 3 clinical development with an oral formulation and IV formulation.
  • Sulopenem has demonstrated potent in vitro activity against a wide variety of gram-negative, gram-positive and anaerobic bacteria resistant to other antibiotics.
  • Iterum Therapeutics has received Qualified Infectious Disease Product (QIDP) and Fast Track designations for its oral and IV formulations of sulopenem in seven indications.

Iterum Therapeutics Reports Second Quarter 2021 Financial Results and Provides Business Update

Retrieved on: 
Friday, August 13, 2021
CRL, Regulation of food and dietary supplements by the U.S. Food and Drug Administration, Forward-looking statement, U.S. Securities and Exchange Commission, Infection, Table, Hand, IV, Research, Company, Food, QIDP, COVID-19, Therapy, GLOBE, Finance Secretary (India), Consultant, Phrase, GAAP, SEC, NDA, Penem, FDA, Security (finance), New Drug Application, Patient, Public policy, Investment, Legislation, Conference, Type, Ens, G&A, Telephone number (mathematics), Nasdaq, ITRM, Bacteria, Maturity, Local, Urinary tract infection, Corporation, Pharmaceutical industry, Dietary supplement, Lithium, Bank

DUBLIN, Ireland and CHICAGO, Aug. 13, 2021 (GLOBE NEWSWIRE) -- Iterum Therapeutics plc (Nasdaq: ITRM), a clinical-stage pharmaceutical company focused on developing next generation oral and IV antibiotics to treat infections caused by multi-drug resistant pathogens in both community and hospital settings, today reported financial results for the second quarter ended June 30, 2021.

Key Points: 
  • Research and development expenses for the second quarter of 2021 were $2.7 million compared to $5.0 million for the same period in 2020.
  • General and administrative (G&A) expenses for the second quarter of 2021 were $4.3 million compared to $3.2 million for the same period in 2020.
  • For the second quarter of 2021, Iterum reported net income of $7.8 million compared to a net loss of $12.5 million for the same period in 2020 due largely to the non-cash adjustment associated with Iterums Royalty-Linked Notes in the second quarter of 2021.
  • Iterum Therapeutics believes that the presentation of non-GAAP adjusted net loss and non-GAAP net loss per share, when viewed with its results under GAAP and the accompanying reconciliation, provides useful supplementary information to, and facilitates additional analysis by, investors, analysts, and Iterum Therapeutics management in assessing Iterum Therapeutics performance and results from period to period.

Iterum Therapeutics to Provide Business Update and Report Second Quarter 2021 Financial Results on August 13, 2021

Retrieved on: 
Friday, August 6, 2021
Company, U.S. Securities and Exchange Commission, Bacteria, Nasdaq, Security (finance), COVID-19, Therapy, Endpoint security, Infection, QIDP, Penem, IV, ITRM, SEC, Legislation, Hand, Phrase, GLOBE, Public policy, Forward-looking statement, Pharmaceutical industry

Management will host a conference call at8:30 a.m. ETthat day to discuss the Companys financial results and provide an update on its business.

Key Points: 
  • Management will host a conference call at8:30 a.m. ETthat day to discuss the Companys financial results and provide an update on its business.
  • After registering, a confirmation email will be sent, including dial-in details and a unique code for entry.
  • Iterum Therapeutics is advancing its first compound, sulopenem, a novel penem anti-infective compound, in Phase 3 clinical development with an oral formulation and IV formulation.
  • Iterum Therapeutics has received Qualified Infectious Disease Product (QIDP) and Fast Track designations for its oral and IV formulations of sulopenem in seven indications.

Iterum Therapeutics to Provide Business Update and Report First Quarter 2021 Financial Results on May 14, 2021

Retrieved on: 
Friday, May 7, 2021
XC2, Penem, Antibiotic, Conference call

Management will host a conference call at\xc2\xa08:30 a.m. ET\xc2\xa0that day to discuss the Company\xe2\x80\x99s financial results and provide an update on its business.\nTo register for the conference call please use this link: https://www.incommglobalevents.com/registration/client/7304/iterum-thera... .

Key Points: 
  • Management will host a conference call at\xc2\xa08:30 a.m. ET\xc2\xa0that day to discuss the Company\xe2\x80\x99s financial results and provide an update on its business.\nTo register for the conference call please use this link: https://www.incommglobalevents.com/registration/client/7304/iterum-thera... .
  • \xc2\xa0\xc2\xa0 After registering, a confirmation email will be sent, including dial-in details and a unique code for entry.
  • Iterum Therapeutics is advancing its first compound, sulopenem, a novel penem anti-infective compound, in Phase 3 clinical development with an oral formulation and IV formulation.
  • Sulopenem has demonstrated potent in vitro activity against a wide variety of gram-negative, gram-positive and anaerobic bacteria resistant to other antibiotics.