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IRLAB Therapeutics - Q3 report: Pirepemat on track to topline

30 oktober 2024

<a id="bm-comp-0d65c59b-b730-4987-9984-8130b3ae3673" name="bm-comp-0d65c59b-b730-4987-9984-8130b3ae3673" class="BMCustomAnchor"></a><table><tr><td bm-component-id="0d65c59b-b730-4987-9984-8130b3ae3673" style="vertical-align: top; width:100.000000%;"><ul><li>Pirepemat Ph 2b rolling towards topline</li><li>IRL757 Ph 1 studies ongoing</li><li>Webcast today at 10:00 CET</li></ul></td></tr></table><a id="bm-comp-be24ad9f-f282-40c9-bbf5-102dd8fcf4e6" name="bm-comp-be24ad9f-f282-40c9-bbf5-102dd8fcf4e6" class="BMCustomAnchor"></a><table><tr><td bm-component-id="be24ad9f-f282-40c9-bbf5-102dd8fcf4e6" style="vertical-align: top; width:100.000000%;"><h3 class="bm-h3">Events during the quarter</h3><p>During the quarter, IRLAB received the green light from the data safety monitoring board (DSMB) of pirepemat's React-PD Ph 2b study. The board unanimously recommended the study continuation. At the end of Q3, IRLAB achieved <a href="https://abg-portal.bluematrix.com/report/c7fb0643-8ce0-4e36-8e05-5e0e27a0d3e2" target="_blank">completion of React-PD enrolment</a>, with &gt;100 patients recruited into the study, sufficient to demonstrate a potential treatment effect. In September, IRLAB secured additional patent protection for its two lead drug candidates mesdopetam and pirepemat, extending their patent protection in Europe/US, respectively, extending patent protection into the early 2040s. Starting from 1 August, Kristina Torfg&#229;rd took over the CEO position from Gunnar Olsson, who remains a board member. After the reporting period, in October, IRLAB announced the initiation of a second Ph 1 study with IRL757 in healthy elderly adults 65 years and older. The first SAD/MAD Ph 1 study in healthy younger subjects was started in spring this year, finished the single ascending dose (SAD) part and is proceeding with the multiple ascending dose (MAD) according to the plan.</p><h3 class="bm-h3">Financials</h3><p>Cash flow from operations was SEK -6.8m (SEK 107m in Q2'24). Cash and cash equivalents came in at SEK 90.4m (SEK 98.3m in Q2'24). During the quarter, IRLAB received a payment of ~SEK 3.4m from MJFF related to the financing of the ongoing IRL757 Ph 1. All booked revenue comes from research collaborations/service revenue invoiced to partners (in total SEK 9m in Q3). Other operating revenue corresponds to the share of the MJFF grant which can be recognized as revenue. In October, IRLAB received USD 2.5m from its partner MSRD related to the initiation of a second Ph 1 study in elderly adults. IRLAB's financial runway extends past pirepemat's topline readout (Q1) into Q2'25e. The Fenja Capital/Formue Nord loan (SEK 55m) matures in May'25.</p><h3 class="bm-h3">Upcoming milestones</h3><p>Topline results from pirepemat's Ph 2b study are expected at the end of Q1'25. Both IRL757 Ph 1 studies are expected to be completed by YE'24e. Topline results from IRL757's MJFF-financed first Ph 1 study are expected in Q1'25e. Regarding IRL757's MSRD-sponsored Ph 1 in elderly adults, we believe that MSRD might opt for not releasing the data, but we have no reason to believe that the drug's PK/PD profile differs significantly between elderly and a general adult population. IRLAB will host a webcast incl. Q&amp;A today at 10:00 CET, viewable at: <a href="https://www.youtube.com/live/FTY_I6oungQ" target="_blank">link</a>.</p></td></tr></table>

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