Earnings release
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ASX Announcement IMUGENE Quarterly Activities and Cash Flow Report Quarter ended 31 December 2020 SYDNEY , Australia , 29 January 2021 : Imugene Limited ( ASX : IMU ) , a clinical stage immuno - oncology company , is pleased to announce its Quarterly Cash Flow report ( Appendix 4C ) for the quarter ended 31 December 2020 . Key highlights this quarter include : $ 32.8m cash balance as at 31 December 2020 . Quarterly research and development expenditure was $ 3.9m • HER - Vaxx showed positive Overall Survival from Interim Data reviewed by the Independent Data Monitoring Committee ( IDMC ) • HER - Vaxx completed enrolment in the Phase 2 study in gastric cancer patients • PD1 - Vaxx received FDA IND Approval and Ethical trial approvals in the USA • PD1 - Vaxx completed enrolment into the first cohort on 17th December 2020 . $ 5.7m was received in November 2020 for the IMUOA Options $ 4.8m was received in December 2020 in R & D tax incentive Update on Clinical Trials HER - Vaxx Phase 2 interim analysis safety and efficacy data were reviewed at the IDMC meeting . As a result of the review , the IDMC reported no safety concerns and viewed this preliminary data as strongly in favour of a HER - Vaxx survival effect . The interim analysis results from this clinical proof - of - concept study , which was designed with a specified 1 - sided false positive probability of 0.10 , showed twice as many patients survived on the HER - Vaxx plus SOC chemotherapy treatment arm compared to the SOC chemotherapy control arm . This translated into an overall survival HR of 0.418 ( 80 % 2 - sided CI : 0.186 , 0.942 ) with a statistically significant 1 - sided p - value of 0.083 . There was no difference in safety events between the two treatment arms , suggesting that HER - Vaxx does not add toxicity to SOC chemotherapy . The IDMC provided guidance that it is scientifically and ethically appropriate to reduce the overall number of patients required to complete the study given the strong signal observed in the data ; Subsequently to the end of the quarter , HER - Vaxx completed enrolment into the open label Phase 2 study on 7th January 2021 . PD1 - Vaxx received US Food and Drug Administration ( FDA ) Investigational New Drug ( IND ) approval to initiate a Phase I clinical trial of its checkpoint immunotherapy candidate , PD1 - Vaxx in USA on the 2nd November 2020 . Shortly after the FDA approval , the first patient in the Phase I clinical trial of PD1 - Vaxx was dosed on 30th November 2020 and the first cohort of three patients were completed on 17th December 2020 . Subsequently to the end of the quarter , clinicians reported no safety , toxicity or tolerability issues with PD1 - Vaxx during the first low dose cohort of patients at the Cohort Review Committee ( CRC ) meeting held on 21st January 2021. The CRC approved enrolment of patients to the next higher dose level . IMUGENE LIMITED ACN 009 179 551 WWW.IMUGENE.COM info@imugene.com