Modus Therapeutics Updates on Sevuparin Phase 1b Clinical Trial Timelines

STOCKHOLM, SWEDEN – 25 May 2022: Modus Therapeutics Holding AB, a biopharma company focused on the clinical development of its proprietary asset sevuparin for the treatment of sepsis/septic shock and other conditions with systemic inflammation, provides an update on its ongoing Phase 1b LPS-challenge study and its other clinical activities with sevuparin.

Modus has observed that the ongoing effects of the Covid-19 pandemic throughout spring have slowed down enrolment for the Phase 1b trial, causing a delay to the anticipated timelines. This is largely attributed to subjects being unable to take part if they have contracted Covid-19 or have had a Covid vaccination within the screening/enrolment period. The company now expects to finalize recruitment by end Q3. Due to the delay caused by external circumstances mainly relating to the pandemic and outside of company control, the previously announced interim analysis cannot be performed within the anticipated timelines and is therefore cancelled.

Modus is now focused on improving the pace of recruitment into the trial and has taken several initiatives to ensure acceleration for full enrollment. These include updates to the selection criteria which now allows the enrolment of female subjects into the study.

John Öhd, CEO of Modus Therapeutics said: “We are now focused on delivering the fully recruited Phase 1b trial according to our updated timeline. The significant potential for sevuparin as a new treatment for sepsis was demonstrated by access to the 11,5 MSEK bridge financing that our major shareholder Karolinska Development provided last week. This will ensure an extended cash runway and the maintained momentum in the preparatory work for our planned Phase 2a clinical trial, as well as the recruitment initiatives and conduct of the ongoing Phase 1b trial. We look forward to providing more updates on our progress as we diligently work towards this important milestone for the study and the development of sevuparin.”

This information is such information that Modus Therapeutics Holding AB is obliged to publish in accordance with the EU Market Abuse Regulation. The information was submitted, through the care of the contact person below, for publication on May 25, 2022.

For more information on Modus Therapeutics, please contact:

John Öhd, VD, Modus Therapeutics

Phone: +46 (0) 70 766 80 97

Email: john.ohd@modustx.com

Certified Adviser

Svensk Kapitalmarknadsgranskning AB

Phone: +46 11 32 30 732

Email: ca@skmg.se

About Modus Therapeutics and sevuparin

Modus Therapeutics is a Swedish biotechnology company headquartered in Stockholm that develops sevuparin with a focus on diseases with a high unmet medical need. The company's focus in the near future is to develop sevuparin for patients with sepsis / septic shock, which is a serious and often fatal condition. Modus Therapeutics is listed on the Nasdaq First North Growth market (“MODTX”). More information is available at www.modustx.com

Sevuparin is a clinical stage, innovative proprietary polysaccharide drug with a multimodal mechanism of action, including anti-inflammatory, anti-adhesive and anti-aggregate effects.  Sevuparin is a heparinoid with markedly attenuated anti-coagulation features that allows severalfold higher doses to be given, compared to regular heparinoids, without the associated risk for bleeding side-effects. Two routes of administration of sevuparin are currently being tested – an IV formulation for in-patient administration and a subcutaneous formulation that allows ambulatory and home care administration.