Wilsons - Adding Autoimmune to the indication list; Mtn Overweight, A$0.90 Tgt (Analysts: Dr Melissa Benson and Dr Shane Storey)

Date	Theme	Sector
18 April 2024	Alert	Healthcare
		Company

Immutep Limited (IMM)

Adding Autoimmune to the indication list

| Announcement Highlights

Immutep have announced their plans for the first clinical study of their LAG-3 agonist, IMP761, for the potential treatment of autoimmune conditions. The trial will be a first-in-human safety Phase I trial to enroll ~49 healthy volunteers being conducted at the Centre for Human Drug Research (CHDR) in Leiden, Netherlands. The CHDR is an independent trials centre specializing in early stage and first-in-human drug research, with unique immunomodulatory challenge models that will help generate important pharmacological drug response data. To date, investors', including our own modelling, has been focused and limited to Immutep's immuno- oncology assets - namely Efti. IMP761 we have always seen as a compelling asset, albeit early in the pipeline. Moving this asset into clinical development this year (mid CY24 trial start) forces it to become a consideration in IMM valuation.

RecommendationOVERWEIGHT

Dr Melissa Benson

[e-mail]

Tel. [phone]

Dr Shane Storey

[e-mail]

Tel. [phone]

Madeleine Williams

[e-mail]

Tel. [phone]

| Wilsons' View

Initial analysis

Phase I IMP761 trial. The trial will seek to enrol 49 healthy volunteers to be administered IMP761 in a dose-ranging manner. Primary outcomes are focused on safety and tolerability as well as collection of Pharmacokinetic (PK) and Pharmacodynamic (PD) data. The trial will include a placebo group. The study will include use of CDHR's keyhole limpit haemocyanin (KLH) challenge model within the trial - a test designed in house to evaluate immunomodulatory response to investigational compounds (IMP761 in this case) that provides key clues as to potential immunomodulatory impacts/efficacy in early stage human trials, utilising healthy- volunteers. The KLH test can be used to identify pharmacologically active dose of investigational drugs to inform follow on Phase II trial designs in target patient populations.

Autoimmune opportunity as large as oncology. The rationale supporting IMM's approach to autoimmune disease with a LAG-3agonist (IMP761) has already been supported in published literature, demonstrating key involvement of LAG-3signalling. IMP761 provides potential to be a disease modifying solution as opposed to current approaches that block mediators further downstream in the immune/inflammatory pathway (i.e. Humira). Abbvie's blockbuster Humira is a relevant predicate when thinking about the end market opportunity for IMP761 should it demonstrate efficacy at correcting immune response, noting that Humira has totalled ~US$20B sales across key autoimmune indications annually (incl. $6B in rheumatoid arthritis).

Earnings implications

No immediate changes, but we begin to build out potential market models for major autoimmune indications (notably rheumatoid arthritis) to identify opportunity sizing for IMP761 in the event of positive Phase I data in the coming year.

Investment view

Maintain OVERWEIGHT and our risked $0.90/sh PT, noting this does not yet include any attribution for IMP761. The next material catalysts for IMM include; a) announcement of their finalised trial design (and potential partner) for the TACTI-004 1L mNSCLC Phase III program (2Q'24); and b) topline data from Phase IIb TACTI-003 trial in 1L mHNSCC (~3Q'24). Unrisked PT at $6.09/sh.

Wilsons Advisory Equity Research

Analyst(s) who owns shares in the Company: n/a Issued by Wilsons Advisory and Stockbroking Limited (Wilsons Advisory) ABN 68 010 529 665 - Australian Financial Services Licence No 238375, a participant of ASX Group and should be read in conjunction with the disclosures and disclaimer in this report. Important disclosures regarding companies that are subject of this report and an explanation of recommendations can be found at the end of this document.

18 April 2024	Healthcare
	Immutep Limited

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18 April 2024	Healthcare
	Immutep Limited

Disclaimers and Disclosures

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Wilsons Advisory restricts research analysts from trading in securities for which they write research. Other Wilsons Advisory employees may hold interests in the company, but none of those interests are material. Wilsons Advisory further advises that at the date of this report, neither Wilsons Advisory and Stockbroking Limited or Wilsons Corporate Finance Limited have any material interests in the company. Wilsons Corporate Finance Limited ACN 057 547 323, AFSL 238 383 acted as Joint Lead Manager and underwriter in the May 2023 pro rata accelerated non-renounceable entitlement offer and Institutional Placement of Immutep Limited Securities for which it received fees or will receive fees for acting in this capacity.

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