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ASX/Media Release Immutep Quarterly Activities Report & Appendix 4C Immutep entered late-stage development in the newly validated LAG-3 space Data from 1st line NSCLC and 2nd line HNSCC presented at ASCO Efti to be evalu

Key Takeaway: Immutep Quarterly Activities Report & Appendix 4C SYDNEY, AUSTRALIA 13 July 2021 Immutep Limited (ASX: IMM; NASDAQ: IMMP) ( Immutep or the Company ), a biotechnology company developing novel LAG-3 related immunotherapy treatments for cancer and autoimmune disease, provides an u

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Immutep Quarterly Activities Report & Appendix 4C
SYDNEY, AUSTRALIA 13 July 2021 Immutep Limited (ASX: IMM;
NASDAQ: IMMP) ( Immutep or the Company ), a biotechnology company developing novel LAG-3 related immunotherapy treatments for cancer and autoimmune disease, provides an update on the
ongoing development of its product candidates, eftilagimod alpha ( efti ) and IMP761 for the quarter ended 30 June 2021.
quarter Immutep has entered a new phase as a biotech company at the forefront of the LAG-3 immunotherapeutic landscape. We are now advancing the development of efti in multiple different cancers and have the
ongoing support of large pharma collaboration partners, including MSD and Merck Germany, for many of our trials. We have begun planning for our new Phase III study in metastatic breast cancer which, if positive, could provide us with registration
data and have a number of new and ongoing other trials progressing at pace. Manufacturing scale up of efti to potential commercial quantities is progressing well, said Marc Voigt, CEO of Immutep.
All of this company activity is taking place in an exciting LAG-3 landscape where the interaction between MHC
class II and LAG-3 has just recently been validated as a therapeutic mechanism for regulating the body s immune system to fight cancer. With more LAG-3 related
programs under development than any other biotech or pharma in the space, we are very excited about the future, he concluded.
AIPAC - Phase IIb clinical trial - ongoing
The trial is on track to report final overall survival (OS) data in H2 of calendar year 2021. Immutep previously reported OS data from approximately 60% of
TACTI-003 - Phase IIb clinical trial - new
Immutep received Fast Track designation in 1st line recurrent or metastatic head and neck squamous cell
carcinoma (HNSCC) from the United States Food and Drug Administration (FDA) in April 2021. This opens the potential for expedited development and review of efti in 1st line HNSCC with the FDA.
Following the close of the quarter, Immutep completed the necessary regulatory steps with the US FDA and obtained institutional review board approval in
the US to commence the TACTI-003 trial. Patient recruitment is expected to begin in this quarter.
Immutep Limited, Level 12, 95 Pitt Street, Sydney NSW 2000
TACTI-002 (also designated
KEYNOTE-798) - Phase II clinical trial - ongoing
At ASCO 2021, Immutep reported updated interim results
from TACTI-002 showing the combination therapy of efti and pembrolizumab demonstrates a very favourable overall response rate (ORR) together with very encouraging duration and depth of response in 1st line non-small cell lung cancer (NSCLC) (Part A) and 2nd line HNSCC (Part C). Tumor responses were seen
in all PD-L1 subgroups, including in low PD-L1 expressing patients which are typically less responsive to
anti-PD-1 therapy. Importantly, the combination therapy continues to be safe and well tolerated.
Recruitment continues for the additional 74 1st NSCLC patients for the expansion of Part A, with 33
patients already enrolled and for Stage 2 of Part B, which has 8 patients now enrolled. Recruitment is tracking better than projected for the expansion cohort of Part A and as originally projected for Stage 2 of Part B. Immutep expects to report
further interim data for TACTI-002 in calendar year 2021 or early calendar year 2022.
INSIGHT is an investigator-initiated phase I trial investigating different combination treatments with efti and a different route of administration for efti.
INSIGHT consists of 5 different arms from stratums A to E.
INSIGHT-005 - combination with bintrafusp-alpha
Immutep signed a collaboration and supply agreement with Merck KGaA, Darmstadt, Germany for a new stratum in 12 patients with solid tumours,
known as Stratum E or INSIGHT-005. The trial will be run as an amendment to the protocol of the ongoing INSIGHT trial as the fifth arm and will evaluate efti in combination with Merck KGaA s and
GlaxoSmithKline s bintrafusp alfa. The first patient is expected to be enrolled in H2 of calendar year 2021.
INSIGHT-004 - combination with avelumab - final data
At ASCO 2021, Immutep also reported encouraging final data from its INSIGHT-004 arm (stratum D). Promising activity
signals were demonstrated from the combination of efti and avelumab, with a response rate of 41.7% in patients with different solid tumours. In addition, deep and durable responses were seen in patients with low or no
PD-L1 expression and in indications such as gastroesophageal and cervical cancer which typically do not respond to immune checkpoint therapy. Importantly, the combination therapy showed a good safety profile.
INSIGHT-003 - triple combination - new
INSIGHT-003 is a new stratum in up to 20 patients with various solid tumours, also referred to as Stratum C. This is
Immutep s first evaluation of efti in a triple combination therapy of efti, chemotherapy and anti-PD-1 therapy. All regulatory and ethical approvals have already
been received, enabling patient recruitment to commence. The first patient is expected to be enrolled in Q3 of calendar year 2021, with first interim results expected in 2022.
The results of INSIGHT-003 are expected to inform a potential Phase II evaluating efti as part of a triple combination
therapy along with an anti-PD-1 therapy and a chemotherapy, potentially in NSCLC.
EAT COVID - Phase II clinical trial - ongoing
randomised portion of the investigator-initiated EAT COVID study is progressing at the University Hospital Pilsen in the Czech Republic. It is evaluating efti in up to 110 hospitalised patients with COVID-19.
Level 12, 95 Pitt Street, Sydney NSW 2000
Preclinical Pipeline
Immutep continues to work on GMP manufacturing preparations for IMP761 and is planning for toxicology studies and other
pre-clinical evaluations.
In addition, under a collaboration project commenced in 2019 with Cardiff University,
Immutep has advanced the discovery and development of a potential new generation of small molecule anti-LAG-3 therapies. The project aims to make an oral treatment
available to cancer patients and at a lower cost compared with the current anti-LAG-3 antibodies being developed by several other companies.
Immutep s licensing and collaboration
partnerships with Labcorp, GSK, Novartis, EOC Pharma and CYTLIMIC continue to progress.
Intellectual Property
Immutep was granted three new patents during the quarter, further expanding the company s global patent estate. The European Patent Office granted a
patent directed to combination therapy with leramilimab (LAG525), Immutep s IMP701 antibody which is out-licensed to Novartis AG, and also a new divisional patent for efti in combination with a PD-1 or PD-L1 inhibitor. In addition, the Chinese Patent Office granted a new patent for efti in combination with chemotherapy, building on corresponding Australian, European,
Japanese and United States patents.
Financial Summary - Q4 FY21
Cash receipts from customers for the quarter was $10k, compared to $59k in Q3 of FY 2021 (i.e. the quarter ended 31 March 2021).
The net cash used in G&A activities in the quarter was $409k compared to $242k in Q3. The increase compared with last quarter is mainly related to capital
raising related activities. Payments to Related Parties, detailed in Item 6 of the Appendix 4C cash flow report for the quarter includes $128k in payment of Non-Executive Director s fees and Executive
The net cash used in Research and Development activities in the quarter was $5.45 million, compared to $1.74 million in
Q3. The significant increase is mainly due to the payment of upfront costs for the TACTI-003 clinical trial in Q4. Cash flow used in R&D activities for FY2021 was $12.47 million compared to
$19.87 million for FY 2020. The decline of cash used in R&D activities in FY 2021 compared with FY 2020 is mainly due to the declining AIPAC expenses since patients in the AIPAC Phase IIb clinical trial have completed the treatment and
moved into the follow-up phase and due to more material expenses related to the Phase IIb TACTI-003 clinical trial only starting to become payable during Q4 FY 2021.
Total net cash outflows used in operating activities in the quarter was $5.71 million. In comparison, total net cash outflows from operating activities in Q3 was $3.05 million.
Level 12, 95 Pitt Street, Sydney NSW 2000
Immutep received a A$1,155,055 cash rebate from the Australian Federal Government s R&D tax
incentive program during the quarter.
In June 2021, Immutep secured commitments for $60 million via a
two-tranche institutional placement which was supported by multiple institutional investors in Australia and offshore.
The Company s cash and cash equivalent balance as at 30 June 2021 was $60.59 million compared to a balance of $51.7 million as at
31 March 2021. This includes $13.7m from the first tranche of the institutional placement and $605k from the exercise of US warrants over American Depository Shares.
A further $46.3 million will be raised from the second tranche of the placement conditional on shareholder approval at the Company s Extraordinary
General Meeting on 26 July 2021.
In addition, Immutep is seeking to raise a further ~$5 million from eligible shareholders via a Share Purchase
Plan (SPP), which closes on Monday, 19th July 2021 at 5pm (Sydney, Australia time).
Appendix 4C - Quarterly Cash Flow Report for the quarter is attached.
Immutep is a globally active biotechnology company that is a leader in the development of LAG-3 related
immunotherapeutic products for the treatment of cancer and autoimmune disease. Immutep is dedicated to leveraging its technology and expertise to bring innovative treatment options to market for patients and to maximize value to shareholders.
Immutep is listed on the Australian Securities Exchange (IMM), and on the NASDAQ (IMMP) in the United States.
Immutep s current lead product
candidate is eftilagimod alpha ( efti or IMP321 ), a soluble LAG-3 fusion protein (LAG-3Ig), which is a first-in-class antigen presenting cell (APC) activator being explored in cancer and infectious disease. Immutep is also developing an agonist of LAG-3 (IMP761) for
autoimmune disease. Additional LAG-3 products, including antibodies for immune response modulation, are 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:
+61 (0)406 759 268; cstrong@citadelmagnus.com
Tim McCarthy, LifeSci Advisors
+1 (212) 915.2564; tim@lifesciadvisors.com
announcement was authorised for release by the Board of Immutep Limited.
Level 12, 95 Pitt 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 June 2021
Consolidated statement of cash flows Current quarter $A 000 Year to date (12 months) $A 000
1. Cash flows from operating activities
1.1 Receipts from customers 10 428
1.2 Payments for
(a) research and development (5,453 ) (12,469 )
(b) product manufacturing and operating costs
(c) advertising and marketing (163 ) (493 )
(d) leased assets
(e) staff costs (871 ) (3,762 )
(f) administration and corporate costs (409 ) (2,818 )
1.3 Dividends received (see note 3)
1.4 Interest received 26 113
1.5 Interest and other costs of finance paid (3 ) (13 )
1.6 Income taxes paid
1.7 Government grants and tax incentives 1,155 1,315
1.8 Other (provide details if material) 26
1.9 Net cash from / (used in) operating activities (5,708 ) (17,673 )
2. Cash flows from investing activities
2.1 Payments to acquire or for:
(a) entities
(b) businesses
(c) property, plant and equipment (4 ) (17 )
(d) investments
(e) intellectual property
(f) other non-current assets (7 )
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 (12 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 (4 ) (24 )
3. Cash flows from financing activities
3.1 Proceeds from issues of equity securities (excluding convertible debt securities) 13,735 43,307
3.2 Proceeds from issue of convertible debt securities
3.3 Proceeds from exercise of options 605 11,266
3.4 Transaction costs related to issues of equity securities or convertible debt securities (622 ) (2,124 )
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) -Initial SPP proceeds received during offer period up to 30 Jun 2021 (offer opened 28 June & closes 19 July 2021). -Payment for the finance lease liability under AASB 16) 465 (61 ) 465 (229 )
3.10 Net cash from / (used in) financing activities 14,122 52,685
ASX Listing Rules Appendix 4C (17/07/20) Page 2
+ See chapter 19 of the ASX Listing Rules for defined terms.
Last updated: Jul 14, 2021