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ASX/Media Release Immutep Quarterly Activities Report & Appendix 4C Clinical development strategy for efti to prioritise non-small cell lung cancer (NSCLC), as well as advance head & neck squamous cell cancer (HNSCC) and

Key Takeaway: Immutep Quarterly Activities Report & Appendix 4C SYDNEY, AUSTRALIA 25 October 2022 Immutep Limited (ASX: IMM; NASDAQ: IMMP) ( Immutep or the Company ), a clinical-stage biotechnology company developing novel immunotherapies for cancer and autoimmune disease, today provides an

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Immutep Quarterly Activities Report & Appendix 4C
SYDNEY, AUSTRALIA 25 October 2022 Immutep Limited (ASX: IMM; NASDAQ: IMMP)
( Immutep or the Company ), a clinical-stage biotechnology company developing novel immunotherapies for cancer and autoimmune disease, today provides an update on the ongoing development of its product candidates, eftilagimod
alpha ( efti ) and IMP761 for the quarter ended 30 September 2022 (Q1 FY23).
Efti Development Program for Cancer
Immutep has reported consistently strong data from efti across three key cancer indications: NSCLC, HNSCC and MBC, supporting the broad therapeutic potential
of the Company s lead product candidate. Based on compelling data, coupled with the large market opportunity and high unmet need for more durable and tolerable options for patients, Immutep has determined to focus its late-stage clinical
development efforts on 1st line NSCLC in combination with anti-PD-1 therapy. The NSCLC program will be shaped by the
maturing TACTI-002 trial data, initial data from the INSIGHT-003 trial, and feedback from regulatory authorities and other stakeholders.
The Company will also continue to advance its late-stage programs in HNSCC via the TACTI-003 trial and MBC through
planning, regulatory and other steps. Studies expanding efti into additional indications and combinations are also planned, with a new trial in soft tissue sarcoma already announced in the quarter.
This development strategy will position the Company, or a potential partner to fully exploit efti s compelling potential. Aligned with this core
strategy, updates from Immutep s clinical development program are provided below.
designated KEYNOTE-PN798) - Phase II clinical trial
In August, Immutep reported positive interim data from patients with 2nd line NSCLC (Part B) in the ongoing TACTI-002 trial at the 2022 World Conference on Lung Cancer (WCLC 2022) in Austria. The median Overall Survival from
therapy with efti in combination with pembrolizumab reported was 9.7 months. 25% of patients were progression free at the key 6-month mark and 36.5% were alive at 18 months. Importantly, the combination
treatment continues to be safe and well tolerated, and compares favourably to standard of care chemotherapy-based options.
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Following the quarter, the United States Food and Drug Administration (FDA) granted Fast Track designation to
efti in combination with pembrolizumab for the treatment of 1st line non-small cell lung cancer (NSCLC), offering the potential for expedited development
and review. The designation was based on the encouraging Phase II clinical data from 1st line NSCLC patients in the TACTI-002 trial reported by Immutep at
the ASCO 2022 Conference in June 2022 and marks the second Fast Track designation issued by the FDA for efti.
Further data from the TACTI-002 trial will be presented in Q4 of calendar year 2022.
Phase II trial being conducted in collaboration with Merck & Co. ( MSD ). It is evaluating the combination of efti with MSD s anti-PD-1 therapy
KEYTRUDA (pembrolizumab) in NSCLC in 1st and 2nd line, and in HNSCC in 2nd line (Parts A, B and C, respectively). The trial is fully recruited.
TACTI-003 - Phase IIb clinical trial
During the quarter, Immutep continued the recruitment of patients with 1st line HNSCC into the TACTI-003 trial. To date 53 patients out of approximately 154 have been enrolled to participate in the study across the now 25 active
trial sites. A Trial in Progress poster on the Phase IIb TACTI-003 trial will be presented at the upcoming Society for Immunotherapy of Cancer (SITC) Annual Meeting 2022 in early November in Boston, US.
TACTI-003 is a Phase IIb multicentre, open label, randomised and controlled trial. It was granted Fast Track
designation for 1st line HNSCC by the US FDA in 2021.
INSIGHT-003 - triple combination
Patient recruitment continued through the quarter for the INSIGHT-003 investigator-initiated trial. Currently, 14 out
of a total of 20 patients are enrolled. First interim data from INSIGHT-003 will be presented in a poster presentation at the SITC Annual Meeting 2022.
The INSIGHT-003 study evaluates a triple combination therapy consisting of efti and an approved standard of care
combination of chemotherapy (carboplatin and pemetrexed) and an anti-PD-1 therapy in patients with NSCLC adenocarcinomas. The study is being conducted by the Institute
of Clinical Cancer Research (IKF) at Northwest Hospital, Frankfurt, Germany.
New Phase II trial in Soft Tissue Sarcoma
In September, Immutep announced a new investigator-initiated Phase II clinical trial which will be conducted in collaboration with the Maria
Sk odowska-Curie National Research Institute in Poland. The trial will evaluate efti in combination with pembrolizumab and radiotherapy, prior to surgery, in up to 40 patients with select soft tissue sarcoma. The Maria Sk odowska-Curie
National Research Institute of Oncology will primarily fund the study with a grant from the Polish government of 1.5M (~A$2.2M), with Immutep providing efti at no cost. Importantly, the trial expands efti s clinical development
pipeline into a new cancer setting.
The first patient is expected to be dosed in H1 calendar year 2023.
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264 George Street, Sydney NSW 2000
IMP761 Development Program for Autoimmune Disease
During the quarter, Immutep continued preclinical development steps for its autoimmune disease candidate, IMP761, including progressing the development of a
200 litre scale GMP-compliant manufacturing process.
IMP761 is Immutep s immunosuppressive agonist antibody
to LAG-3 which will be tested to treat the causes of autoimmune disease, such as inflammatory bowel disease, rheumatoid arthritis, and multiple sclerosis, rather than merely treating the symptoms.
Intellectual Property
During the quarter, Immutep was
granted two new patents by the Japanese Patent Office. The first protects IMP761, pharmaceutical compositions comprising IMP761, and the use of the compositions in the treatment of T-cell mediated inflammatory
and autoimmune diseases. It follows the grant of a similar European patent announced in October 2020.
The second Japanese patent is directed to combined
therapeutic preparations comprising efti and an anti-PD-(L)1 antibody, and methods of use in the treatment of cancer and infection.
A third patent was also granted during the quarter. This patent was granted by the Russian Patent Office and is directed to combined therapeutic preparations
comprising efti and an anti-PD-(L)1 antibody. These new efti related patents in Japan and Russia build on corresponding patents granted in Australia, Europe, United
States and China, as announced in 2018 through 2022.
In September, Immutep appointed its Chief Scientific Officer and Chief Medical Officer, Professor Fr d ric Triebel, M.D. Ph.D. as Executive
Director on its Board. Professor Triebel pioneered the recently validated LAG-3 field of immuno-oncology, having discovered the LAG-3 gene and is a driving force in the
strategic development of Immutep s LAG-3 product candidates.
Immutep s financial performance over the quarter (Q1 FY23) continues to be pleasing. Cash receipts from customers Q1 FY23 decreased to $33k, compared to
$96k in Q4 FY22. In September 2022, the company received a 1.8 million (~A$2.7 million) research and development (R&D) tax incentive payment in cash from the French Government under its Cr dit d Imp t Recherche
The net cash used in G&A activities in the quarter was $595k compared to $361k in Q4 FY22. The increase compared with the last quarter
is mainly due to the payment of annual audit fees.
Payments to Related Parties, detailed in Item 6 of the Appendix 4C cash flow report for the quarter
includes $167k in payment of Non-Executive Director s fees and Executive Director s remuneration.
net cash used in R&D activities in the quarter was $7.17 million, compared to $7.62 million in Q4 FY22. The cash outflow for clinical trial activities decreased compared with Q4 FY22 while the cash outflow for manufacturing activities
significantly increased in Q1 FY2023. Total net cash outflows used in operating activities in the quarter was $6.34 million compared to $9.28 million in Q4 FY22.
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Immutep s cash and cash equivalent balance as at 30 September 2022 was approximately
$73.9 million compared to a balance of $80 million as at 30 June 2022, giving the Company an expected cash reach based on current estimates of early calendar year 2024. Immutep will continue to manage its strong cash balance carefully
as it reviews its overall clinical strategy, particularly in light of the various potential opportunities for the development of efti in cancer.
of the Appendix 4C - Quarterly Cash Flow Report for the quarter is attached.
Immutep is a clinical stage biotechnology company leading the development of LAG-3 related immunotherapy products for
the treatment of cancer and autoimmune disease. The Company is dedicated to leveraging its technology and expertise to bring innovative treatment options to market for patients and to maximize value to shareholders.
Immutep s lead product candidate is eftilagimod alpha ( efti or IMP321 ), a soluble LAG-3
fusion protein (LAG-3Ig) that is a first-in-class antigen presenting cell (APC) activator being evaluated in multiple clinical
trials for cancer. The Company is also developing an agonist of LAG-3 (IMP761) for autoimmune disease. Additional LAG-3 product candidates, including antibodies for
immune response modulation, are licensed to and being developed by Immutep s large pharmaceutical partners.
Further information can be found on the
Company s website www.immutep.com or by contacting:
Australian Investors/Media:
Catherine Strong, Citadel-MAGNUS
McCarthy, LifeSci Advisors
+1 (917) 679 9282; tim@lifesciadvisors.com
This announcement was authorised for release by the Board of Immutep Limited.
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264 George Street, Sydney NSW 2000
Quarterly cash flow report for entities
subject to Listing Rule 4.7B
Name of entity
Immutep Limited
ABN Quarter ended ( current quarter )
90 009 237 889 30 September 2022
Consolidated statement of cash flows Current quarter $A 000 Year to date (3 months) $A 000
1. Cash flows from operating activities
1.1 Receipts from customers 33 33
1.2 Payments for
(a) research and development (7,171 ) (7,171 )
(b) product manufacturing and operating costs
(c) advertising and marketing (118 ) (118 )
(d) leased assets
(e) staff costs (1,248 ) (1,248 )
(f) administration and corporate costs (595 ) (595 )
1.3 Dividends received (see note 3)
1.4 Interest received 121 121
1.5 Interest and other costs of finance paid (29 ) (29 )
1.6 Income taxes paid
1.7 Government grants and tax incentives 2,659 2,659
1.8 Other (provide details if material)
1.9 Net cash from / (used in) operating activities (6,348 ) (6,348 )
2. Cash flows from investing activities
2.1 Payments to acquire or for:
(a) entities
(b) businesses
(c) property, plant and equipment (10 ) (10 )
(d) investments
(e) intellectual property
(f) other non-current assets
ASX Listing Rules Appendix 4C (17/07/20) Page 1
+ See chapter 19 of the ASX Listing Rules for defined terms.
Quarterly cash flow report for entities subject to Listing Rule 4.7B
Consolidated statement of cash flows Current quarter $A 000 Year to date (3 months) $A 000
2.2 Proceeds from disposal of:
(a) entities
(b) businesses
(c) property, plant and equipment
(d) investments
(e) intellectual property
(f) other non-current assets
2.3 Cash flows from loans to other entities
2.4 Dividends received (see note 3)
2.5 Other (provide details if material)
2.6 Net cash from / (used in) investing activities (10 ) (10 )
3. Cash flows from financing activities
3.1 Proceeds from issues of equity securities (excluding convertible debt securities)
3.2 Proceeds from issue of convertible debt securities
3.3 Proceeds from exercise of options
3.4 Transaction costs related to issues of equity securities or convertible debt securities
3.5 Proceeds from borrowings
3.6 Repayment of borrowings
3.7 Transaction costs related to loans and borrowings
3.8 Dividends paid
3.9 Other (provide details if material) -Payment for the finance lease liability under AASB 16) (51 ) (51 )
3.10 Net cash from / (used in) financing activities (51 ) (51 )
4. Net increase / (decrease) in cash and cash equivalents for the period
4.1 Cash and cash equivalents at beginning of period 79,995 79,995
4.2 Net cash from / (used in) operating activities (item 1.9 above) (6,348 ) (6,348 )
ASX Listing Rules Appendix 4C (17/07/20) Page 2
+ See chapter 19 of the ASX Listing Rules for defined terms.
Last updated: Oct 26, 2022