REVIEW OF OPERATIONS
On behalf of the directors and management of Immutep, it is my pleasure to report on Immutep’s operations for the 2019 financial year.
The financial year 2019 has been a year of growth and good progress for Immutep, clinically and with partnerships.
Building on its clinical trial pipeline, the Company commenced two new clinical trials during the year:TACTI-002, a Phase II study in head and neck squamous cell carcinoma(2nd line) andnon-small cell lung cancer (1st and 2nd line), andINSIGHT-004, an extension to the existing investigator initiated INSIGHT study in advanced solid tumours. Both these trials will enhance our understanding of efti, its value and its application in new cancer settings and in different combinations(anti-PD1 andanti-PDL-1).
The Company reported positive interim results from its Phase ITACTI-mel study in melanoma patients, after completing recruitment for the trial in August 2018. Encouraging preclinical results were also reported for IMP761 in September 2018, demonstrating its immunosuppressive activity in vivo and supporting its progress towards clinical trials in autoimmune diseases. These results were presented in more detail at the ECCO conference in March 2019.
Additionally, Immutep completed in June 2019 the recruitment of 227 patients to its Phase IIb AIPAC study in metastatic breast cancer and is expecting to report first efficacy data from this potentially pivotal trial in Q1 of calendar year 2020.
During the financial year, Immutep received approval of its Investigational New Drug (IND) application from the US Food and Drug Administration (FDA) for efti in July 2018. The IND enables efti to be tested by US clinical investigators participating in the Company’sTACTI-002 Phase II study, making it vital to start the trial in the US.
Marking strong business development progress by the team, Immutep entered into a new clinical trial collaboration and supply agreement with Merck KGaA, Darmstadt, Germany and Pfizer Inc. in September 2018. The collaboration will evaluate the combination of efti with avelumab, a humananti-PD-L1 antibody, in patients with advanced solid malignancies.
Following this new partnership, Immutep is now collaborating with five major pharmaceutical companies: Novartis, GSK, Merck & Co (MSD), Merck (Germany) and Pfizer.
The Company also formalised its collaboration with CYTLIMIC in January 2019 and consequently, efti is now being evaluated as part of three different combination therapy types: as part of a therapeutic cancer vaccine, as a chemo-immunotherapy and in an IO combination, demonstrating its broad therapeutic potential.
In December 2018, the Company raised approximately US$5.2million (A$7.2million) through a registered direct offering of 260,000,000 ordinary shares represented by 2,600,000 American Depositary Shares (ADSs) via its NASDAQ listing and issuing via a private placement warrants to purchase up to 208,000,000 ordinary shares represented by 2,080,000 ADSs.
Subsequent to the year end, Immutep completed a capital raise via the ASX, raising A$4 million in a placement to institutional investors and approximately A$6 million in a fully underwritten Entitlement Offer. The total capital raised of A$10.0 million will be used to continue Immutep’sLAG-3 related programs, especially the ongoing clinical development of efti, as well as the preclinical development of IMP761, and for general corporate purposes.
The Company’s cash runway is expected to extend to the end of calendar year 2020 with the inclusion of an anticipated milestone payment to be received within this cash reach period. However, should receipt of this anticipated milestone be delayed, the Company may correspondingly delay incurring expenses on certain value enabling clinical and manufacturing activities for efti.
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