Treosulfan

Medexus Announces Strongest Quarter in Company History with Fiscal Q2 2023 Revenue of US$27.7 Million, a 55% Increase Over Fiscal Q2 2022

Retrieved on: 
Tuesday, November 8, 2022
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TORONTO and CHICAGO, Nov. 08, 2022 (GLOBE NEWSWIRE) --  Medexus Pharmaceuticals (Medexus) (TSX: MDP) (OTCQX: MEDXF) today announced its operating and financial results and provided a business update for the company’s second fiscal quarter ended September 30, 2022. All dollar amounts in this press release are in United States dollars unless specified otherwise.

Key Points: 
  • Record total revenue of $27.7 million, a year-over-year increase of 55%, and a quarter-over-quarter increase of 20%.
  • This represents the strongest fiscal quarter in Medexuss history.
  • The primary drivers for this substantial year-over-year improvement were increases in revenues, a reduction in research & development costs, and an increase in gross margin.
  • Marcel Konrad, Chief Financial Officer of Medexus, further noted, During the second quarter we delivered an increase in our cash position versus previous quarter and generated positive operating cash flow this quarter.

Medexus Schedules Second Quarter 2023 Conference Call

Retrieved on: 
Wednesday, November 2, 2022
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TORONTO and CHICAGO, Nov. 02, 2022 (GLOBE NEWSWIRE) -- Medexus Pharmaceuticals (Medexus) (TSX:MDP) (OTCQX:MEDXF) plans to host a conference call at 8:00am Eastern Time on Wednesday, November9, 2022 to discuss Medexuss results for its second quarter ended September30, 2022.

Key Points: 
  • TORONTO and CHICAGO, Nov. 02, 2022 (GLOBE NEWSWIRE) -- Medexus Pharmaceuticals (Medexus) (TSX:MDP) (OTCQX:MEDXF) plans to host a conference call at 8:00am Eastern Time on Wednesday, November9, 2022 to discuss Medexuss results for its second quarter ended September30, 2022.
  • Medexus expects to file its financial statements and MD&A after markets close on November 8, 2022.
  • To access the replay, please dial the following numbers
    877-481-4010 for Canadian and U.S. callers
    A replay of the webcast will be available on the InvestorsNews& EventsIRCalendar section of Medexuss corporate website until Thursday, November9, 2023.
  • Medexus is a leader in innovative rare disease treatment solutions with a strong North American commercial platform and a portfolio of proven best-in-class products.

Medexus Announces Preliminary Revenue Results for Second Fiscal Quarter 2023

Retrieved on: 
Thursday, October 6, 2022
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TORONTO and CHICAGO, Oct. 06, 2022 (GLOBE NEWSWIRE) -- Medexus Pharmaceuticals (Medexus) (TSX:MDP) (OTCQX:MEDXF) is pleased to announce preliminary estimates of the companys revenue results for the fiscal quarter ended September30, 2022 (the companys fiscal Q2 2023).

Key Points: 
  • TORONTO and CHICAGO, Oct. 06, 2022 (GLOBE NEWSWIRE) -- Medexus Pharmaceuticals (Medexus) (TSX:MDP) (OTCQX:MEDXF) is pleased to announce preliminary estimates of the companys revenue results for the fiscal quarter ended September30, 2022 (the companys fiscal Q2 2023).
  • Medexus expects to deliver total revenue between $27.0million and $27.5million in fiscal Q2 2023.
  • This will represent the strongest fiscal quarter in Medexuss history, and an increase of at least 51% compared to $17.9million in fiscal Q2 2022 and an increase of at least 17% compared to $23.0million in fiscal Q1 2023.
  • We began shipping Medexus-labeled product to customers across the country in August, meaning that September2022 will be the first full month, and fiscal Q3 2023 the first full fiscal quarter, in which Medexus recognizes 100% of Gleolan net sales.

Medexus and MidCap Agree to Increase in MidCap’s Revolving Loan Commitment Amount

Retrieved on: 
Thursday, September 29, 2022
Treosulfan, TSX, Allergy, FDA, Blood, World Health Organization, Customer service, Rheumatoid arthritis, Midcap, Growth, Hematology, Partnership, Patient, Toronto Stock Exchange, Hematopoietic stem cell transplantation, Health Canada, Methotrexate, GLOBE, Glioma, Pharmaceutical industry, Collaboration

TORONTO and CHICAGO, Sept. 29, 2022 (GLOBE NEWSWIRE) -- Medexus Pharmaceuticals (Medexus) (TSX: MDP) (OTCQX: MEDXF) today entered into an amendment to the company’s revolving credit facility with a syndicate of lenders agented by MidCap Funding IV Trust (MidCap). Among other things, the amendment provides for a US$5.0 million increase in MidCap’s revolving loan commitment amount on substantially the same terms provided under the existing facility. Following the amendment, Medexus will have total borrowing capacity under the revolving credit facility of US$25.0 million subject to the borrowing base.

Key Points: 
  • Among other things, the amendment provides for a US$5.0million increase in MidCaps revolving loan commitment amount on substantially the same terms provided under the existing facility.
  • Following the amendment, Medexus will have total borrowing capacity under the revolving credit facility of US$25.0million subject to the borrowing base.
  • We are pleased to extend our strong partnership with MidCap and bolster our liquidity position as we head into this upcoming quarter, commented Marcel Konrad, Chief Financial Officer of Medexus.
  • Medexus is a leader in innovative rare disease treatment solutions with a strong North American commercial platform and a portfolio of proven best-in-class products.

Medexus Provides Update on Treosulfan NDA Resubmission and Provides Business Update

Retrieved on: 
Monday, September 19, 2022
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TORONTO and CHICAGO, Sept. 19, 2022 (GLOBE NEWSWIRE) -- On Friday, September 16, Medexus Pharmaceuticals (Medexus) (TSX: MDP) (OTCQX: MEDXF) was informed by medac, licensor of Medexus’s commercialization rights to treosulfan, that the U.S. Food and Drug Administration (FDA) has delivered to medac a second notice of incomplete response regarding medac’s new drug application resubmission for treosulfan (NDA). The FDA’s notice requests further supporting information from medac to complete medac’s NDA resubmission but does not require submission of new clinical data. Medexus will provide an update to its shareholders and stakeholders once management knows whether the resubmission has been accepted and is better able to assess the impact of this delay.

Key Points: 
  • The FDAs notice requests further supporting information from medac to complete medacs NDA resubmission but does not require submission of new clinical data.
  • Medexus will provide an update to its shareholders and stakeholders once management knows whether the resubmission has been accepted and is better able to assess the impact of this delay.
  • Medexus has now assumed full responsibility for commercializing Gleolan in the United States and has begun shipping Medexus-labeled product to customers across the country.
  • September2022 will be the first full month in which Medexus recognizes 100% of Gleolan net sales, on which Medexus will pay a tiered annual royalty.

Medexus Holds Annual Meeting of Shareholders and Announces Election of Board of Directors

Retrieved on: 
Thursday, September 15, 2022
Treosulfan, Allergy, FDA, Blood, World Health Organization, Customer service, Rheumatoid arthritis, Growth, Hematology, Patient, Hematopoietic stem cell transplantation, Health Canada, Methotrexate, Glioma, Pharmaceutical industry, Collaboration

TORONTO and CHICAGO, Sept. 15, 2022 (GLOBE NEWSWIRE) -- Medexus Pharmaceuticals (Medexus) (TSX: MDP) (OTCQX: MEDXF) today held its virtual annual meeting of shareholders. Medexus shareholders elected all nominees listed in Medexus’s management information circular dated August 5, 2022 as directors through the next annual meeting. Shareholders also voted in favor of the appointment of PricewaterhouseCoopers LLP as the company’s auditors and in favor of resolutions adopting a new equity compensation plan.

Key Points: 
  • Final voting results on all matters voted on at the annual meeting will be filed with Canadian securities regulatory authorities at www.sedar.com.
  • Medexus is a leader in innovative rare disease treatment solutions with a strong North American commercial platform and a portfolio of proven best-in-class products.
  • Our current focus is on the therapeutic areas of hematology, auto-immune diseases, and allergy.
  • We strive to deliver on this mission by acting on our core values: Quality, Innovation, Customer Service, and Collaboration.

Medexus Announces Record Fiscal Q1 2023 Revenue of US$23.0 Million, a 33% Increase versus Fiscal Q1 2022

Retrieved on: 
Monday, August 8, 2022
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TORONTO and CHICAGO, Aug. 08, 2022 (GLOBE NEWSWIRE) -- Medexus Pharmaceuticals (Medexus) (TSX: MDP) (OTCQX: MEDXF) today announced its operating and financial results and provided a business update for the company’s first fiscal quarter ended June 30, 2022. All dollar amounts in this press release are in United States dollars unless specified otherwise.

Key Points: 
  • Delivered record total revenue of $23.0 million in fiscalQ12023, an increase of 33% compared to $17.3million in fiscalQ12022 and an increase of 13% compared to $20.3million in fiscalQ42022.
  • Achieved Adjusted EBITDA* of $1.9million in fiscalQ12023 compared to $(4.9)million in fiscalQ12022 and $1.1 million in fiscal Q4 2022.
  • Medexus achieved this Adjusted EBITDA increase while continuing to maintain appropriate investments in preparations for a commercial launch of treosulfan in the United States.
  • In addition, in August 2022, Medexus and medac signed an amendment to their February 2021 license agreement for treosulfan.

Medexus Schedules First Quarter 2023 Conference Call

Retrieved on: 
Tuesday, August 2, 2022
Allergy, TSX, GLOBE, Customer service, ALA, Rheumatoid arthritis, Hematology, Health Canada, Treosulfan, World Health Organization, Webcast, Methotrexate, Mission statement, FDA, MD, Glioma, Patient, Blood, Hematopoietic stem cell transplantation, Growth, Pharmaceutical industry, Collaboration

TORONTO and CHICAGO, Aug. 02, 2022 (GLOBE NEWSWIRE) -- Medexus Pharmaceuticals (Medexus) (TSX:MDP) (OTCQX:MEDXF) plans to host a conference call at 8:00am Eastern Time on Tuesday, August9, 2022 to discuss Medexuss results for its first quarter ended June30, 2022.

Key Points: 
  • TORONTO and CHICAGO, Aug. 02, 2022 (GLOBE NEWSWIRE) -- Medexus Pharmaceuticals (Medexus) (TSX:MDP) (OTCQX:MEDXF) plans to host a conference call at 8:00am Eastern Time on Tuesday, August9, 2022 to discuss Medexuss results for its first quarter ended June30, 2022.
  • Medexus expects to file its financial statements and MD&A after markets close on August 8, 2022.
  • To access the replay, please dial the following numbers
    877-481-4010 for Canadian and U.S. callers
    A replay of the webcast will be available on the InvestorsNews& EventsIRCalendar section of Medexuss corporate website until Wednesday, August9, 2023.
  • Medexus is a leader in innovative rare disease treatment solutions with a strong North American commercial platform and a portfolio of proven best-in-class products.

Treosulfan NDA Resubmitted to FDA

Retrieved on: 
Monday, July 25, 2022
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TORONTO and CHICAGO, July 25, 2022 (GLOBE NEWSWIRE) -- Medexus Pharmaceuticals (Medexus) (TSX: MDP) (OTCQX: MEDXF) and medac, a strategic partner of Medexus, are pleased to announce that medac has resubmitted its New Drug Application for treosulfan (NDA) with the U.S. Food and Drug Administration (FDA). The current submission was a response to the FDA request to submit information to complete medac’s April 2022 NDA resubmission and initiate FDA review.

Key Points: 
  • TORONTO and CHICAGO, July 25, 2022 (GLOBE NEWSWIRE) -- Medexus Pharmaceuticals (Medexus) (TSX:MDP) (OTCQX:MEDXF) and medac, a strategic partner of Medexus, are pleased to announce that medac has resubmitted its New Drug Application for treosulfan (NDA) with the U.S.Food and Drug Administration (FDA).
  • The current submission was a response to the FDA request to submit information to complete medacs April2022 NDA resubmission and initiate FDA review.
  • The NDA requests approval of treosulfan in combination with fludarabine as a preparative regimen for allogeneic hematopoietic stem cell transplantation (allo-HSCT).
  • MrdEntremont continued: If approved by the FDA, we expect that treosulfan would have a meaningful impact on Medexuss total revenue.

Medexus Generates Revenue of US$76.7 Million in Fiscal Year 2022 and US$20.3 million in Fiscal Q4 (Strongest Q4 Revenue in Company History)

Retrieved on: 
Wednesday, June 22, 2022
Allergy, Webcast, Review, FDA, NDA, Methotrexate, TSX, MAT, Mission statement, SEDAR, Treosulfan, Pharmacy, Hematopoietic stem cell transplantation, Health Canada, Customer service, EBITDA, Growth, New Drug Application, Rheumatoid arthritis, Glioma, Marketing, IQVIA, Investment, Calendar, World Health Organization, Blood, CDH, Patient, Collection, Total, Hematology, GLOBE, Online gambling, Renewable energy, Spice, Lithium, Pharmaceutical industry, Medical device, Collaboration

Generated total revenue of $76.7 million in fiscal year2022, a decrease of 4% compared to fiscal year2021.

Key Points: 
  • Generated total revenue of $76.7 million in fiscal year2022, a decrease of 4% compared to fiscal year2021.
  • Achieved adjusted EBITDA* of $1.1million in fiscalQ42022 compared to $(1.6)million in fiscalQ42021 and $1.9 million in fiscal Q3 2022.
  • Produced net loss of $5.3million in fiscalQ42022 and $2.9million in fiscal year2022 compared to $10.5million in fiscalQ42021 and $28.3million in fiscal year2021.
  • Generated adjusted net loss* of $4.6million in fiscalQ42022 and $24.0million in fiscal year2022 compared to $5.2million in fiscalQ42021 and $7.6million in fiscal year2021.