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ASX/Media Release IMMUTEP QUARTERLY ACTIVITIES REPORT & APPENDIX 4C Encouraging clinical results from TACTI-002 and INSIGHT-004 trials of eftilagimod alpha Immutep completes recruitment for Stage 1 of Part B in TACTI-002

Key Takeaway: IMMUTEP QUARTERLY ACTIVITIES REPORT & APPENDIX 4C SYDNEY, AUSTRALIA 22 October 2020 Immutep Limited (ASX: IMM; NASDAQ: IMMP) a biotechnology company developing novel immunotherapy treatments for cancer and autoimmune diseases, provides an update on the ongoing development of it

Full Press Release Details

IMMUTEP QUARTERLY ACTIVITIES REPORT & APPENDIX 4C
SYDNEY, AUSTRALIA 22 October 2020 Immutep Limited (ASX: IMM; NASDAQ: IMMP) a biotechnology company
developing novel immunotherapy treatments for cancer and autoimmune diseases, provides an update on the ongoing development of its product candidates, eftilagimod alpha ( efti or IMP321 ) and IMP761, and the activity of its new
and existing partners.
Over the quarter, we have continued to report further supportive data from our trials of efti in multiple cancers. This has
built a strong pool of data to discuss with potential out licensing and collaboration partners. We already have committed partnerships in place with five of the world s largest pharmaceutical companies: Merck, Pfizer, Merck MSD, Novartis and
GSK, plus our partner in China, EOC Pharma, giving us confidence that we can build on our LAG-3 leadership position, said Marc Voigt, CEO of Immutep.
Eftilagimod Alpha Clinical Updates
TACTI-002 - Phase II clinical trial
Immutep presented encouraging interim results from its TACTI-002 trial in two poster presentations at the ESMO Virtual Congress 2020 in September 2020. These results showed three patients had complete responses (complete disappearance of all lesions) to the combination
therapy of efti with KEYTRUDA (pembrolizumab). Two of these patients had second line head and neck squamous cell carcinoma (HNSCC) and one had first line
non-small cell lung cancer (NSCLC). Pleasingly, five partial responses were reported from patients (across both indications) with negative (< 1%) or moderate PD-L1
expression. Pembrolizumab monotherapy is typically less effective in these patients.
A median Progression Free Survival (PFS) of 4.3 months was achieved
for patients with second line HNSCC and 47% of these patients were progression free at the 6-month landmark in this very aggressive late stage disease. For 1st line NSCLC patients, median PFS continues to
improve and is 11.8 months. The combination treatment continues to be safe and well tolerated with no new safety signals reported thus far.
Immutep enrolled and safely dosed the last patient for Stage 1 of Part B (2nd line NSCLC) of TACTI-002, completing recruitment of this stage. Recruitment is also complete for both stages of Part A (1st line
NSCLC) and is ongoing for Stage 2 of Part C (2nd line HNSCC). Pending the Data Monitoring Committee s recommendation, Immutep will consider opening Stage 2 of Part B for recruitment. Overall, recruitment for the trial continues to progress
well, with 92 out of up to 109 patients now enrolled.
TACTI-002 is evaluating the combination of efti with
Merck & Co s KEYTRUDA (pembrolizumab) in up to 109 patients with second line HNSCC or NSCLC in first and second line.
INSIGHT-004 - Phase I clinical trial
Immutep also reported improving interim data from its INSIGHT-004 trial of efti at the ESMO Virtual Congress 2020 in
September 2020. In the trial 41.7% of patients showed a Partial Response to the combination therapy of efti and avelumab, building on the previous interim data of 33%.
Level 12, 95 Pitt Street, Sydney NSW 2000
More importantly, the trial also reported encouraging early anti-tumour activity signals across a variety of
cancer indications not typically sensitive to immune checkpoint inhibitor (ICI) therapy, including PD-L1-negative cervical cancer, squamous anal cell carcinoma, and
mesothelioma. The combination of efti and avelumab continues to be safe and well tolerated.
evaluating the combination of efti with avelumab, a human anti-PD-L1 antibody, in 12 patients with different advanced solid malignancies, primarily gastrointestinal
indications. The trial is being conducted under Immutep s collaboration with Merck KGaA, Darmstadt, Germany, and Pfizer Inc., as the 4th arm of the ongoing INSIGHT Phase I clinical trial. The Institute of Clinical Cancer Research, Krankenhaus
Nordwest GmbH in Frankfurt, Germany ( IKF ) is the trial sponsor for INSIGHT-004.
Immutep is continuing cell line development for IMP761. IMP761 is an immunosuppressive agonist antibody to
LAG-3 for the treatment of autoimmune diseases, such as inflammatory bowel diseases, rheumatoid arthritis, and multiple sclerosis.
In August, Immutep and its research partner, Monash University, were awarded a A$671,427 grant under the Australian Research Council s (ARC) Linkage
Project scheme to support their research collaboration into Lymphocyte Activation Gene-3 (LAG-3) for a further three years. The collaboration commenced in 2017.
Novartis has five clinical trials
ongoing for LAG525 (Ieramilimab) in multiple cancer indications, including a Phase II clinical trial in triple negative breast cancer. According to the Q2 Novartis earnings call a regulatory submission is planned for LAG525 in
Immutep s other partnerships with GlaxoSmithKline, EOC Pharma and CYTLIMIC continue to progress well.
Intellectual Property
In August, the United States
Patent and Trade Mark Office granted Immutep a new patent entitled Combined Preparations for the Treatment of Cancer . The new patent relates to the use of efti in combined therapeutic preparations with a chemotherapy agent and follows
the grant of similar European, Australian and Japanese patents in May 2019, June 2019 and May 2020, respectively. The expiry date of this United States patent is 25 January 2035.
In July, a new patent was granted by the United States Patent and Trade Mark Office entitled Antibody molecules to
LAG-3 and uses thereof . The patent relates to embodiments of LAG525, a humanised form of Immutep s IMP701 antibody which is out-licensed to Novartis AG. The
patent is co-owned by Novartis AG and Immutep S.A.S. and will expire on 26 March 2035.
Level 12, 95 Pitt Street, Sydney NSW 2000
Cash receipts from customers for the quarter were $23k, compared to $128k in Q4 FY2020. Cash receipts from government grants and tax incentives for the quarter
were $126k, compared to $5.1 million in Q4 FY2020.
The net cash used in G&A activities in the quarter was $0.35 million compared to
$0.36 million in Q4 FY2020. G&A costs for the quarter includes $127K in payment of Non-Executive Director s fees and Executive Director s salary.
Total net cash outflows used in operating activities in the quarter was $3.34 million. In comparison, total net cash inflows from the operating
activities in Q4 FY2020 were $0.12 million.
The net cash used in Research and Development activities in the quarter was $2.10 million, compared
to $3.77 million in Q4 FY2020. R&D expenditure declined further as all patients in the AIPAC Phase IIb clinical trial have completed the treatment and moved into the follow-up phase.
Interest paid of $6k is the interest component of the office lease under the application of AASB 16 Leases.
The cash balance as at 30 September 2020 was $22.7 million compared to a balance of $26.3 million as at 30 June 2020. The Company s
cash runway extends to the end of calendar year 2021, beyond several significant data read-outs.
A copy of the Appendix 4C - Quarterly Cash Flow Report
for the quarter is attached.
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 protein (LAG-3Ig) based on the LAG-3 immune control mechanism. This mechanism plays a vital role in the regulation of the T
cell immune response. Efti is currently in a Phase IIb clinical trial as a chemoimmunotherapy for metastatic breast cancer termed AIPAC (clinicaltrials.gov identifier NCT02614833); a Phase II clinical trial being conducted in collaboration with
Merck & Co., Inc., Kenilworth, NJ, USA (known as MSD outside the United States and Canada) referred to as TACTI-002 to evaluate a combination of efti with KEYTRUDA (pembrolizumab) in several different solid tumours (clinicaltrials.gov identifier NCT03625323); a Phase I clinical trial being conducted in collaboration with Merck KGaA, Darmstadt, Germany and
Pfizer Inc. referred to as INSIGHT-004 to evaluate a combination of efti with avelumab (clinicaltrials.gov identifier NCT03252938); and a Phase I combination therapy trial in metastatic melanoma termed
TACTI-mel (clinicaltrials.gov identifier NCT02676869).
Additional LAG-3 products, including antibodies, for
immune response modulation in autoimmunity and cancer are being developed by Immutep s large pharmaceutical partners. Immutep is also developing an agonist of LAG-3 (IMP761) for autoimmune disease.
Further information can be found on the Company s website www.immutep.com or by contacting:
Level 12, 95 Pitt Street, Sydney NSW 2000
Australian Investors/Media:
Catherine Strong, Citadel-MAGNUS
McCarthy, LifeSci Advisors
+1 (212) 915.2564; tim@lifesciadvisors.com
This announcement was authorised for release by the Board of Immutep Limited.
Level 12, 95 Pitt Street, Sydney NSW 2000
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 2020
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 23 23
1.2 Payments for
(a) research and development (2,094 ) (2,094 )
(b) product manufacturing and operating costs
(c) advertising and marketing (122 ) (122 )
(d) leased assets
(e) staff costs (936 ) (936 )
(f) administration and corporate costs (350 ) (350 )
1.3 Dividends received (see note 3)
1.4 Interest received 23 23
1.5 Interest and other costs of finance paid (6 ) (6 )
1.6 Income taxes paid
1.7 Government grants and tax incentives 126 126
1.8 Other (provide details if material)
1.9 Net cash from / (used in) operating activities (3,336 ) (3,336 )
2. Cash flows from investing activities
2.1 Payments to acquire or for:
(a) entities
(b) businesses
(c) property, plant and equipment
(d) investments
(e) intellectual property
(f) other non-current assets
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
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 (Payment for the finance lease liability under AASB 16) (96 ) (96 )
3.10 Net cash from / (used in) financing activities (96 ) (96 )
4. Net increase / (decrease) in cash and cash equivalents for the period
4.1 Cash and cash equivalents at beginning of period 26,322 26,322
4.2 Net cash from / (used in) operating activities (item 1.9 above) (3,336 ) (3,336 )
4.3 Net cash from / (used in) investing activities (item 2.6 above)
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
4.4 Net cash from / (used in) financing activities (item 3.10 above) (96 ) (96 )
4.5 Effect of movement in exchange rates on cash held (179 ) (179 )
4.6 Cash and cash equivalents at end of period 22,711 22,711
5. Reconciliation of cash and cash equivalents at the end of the quarter (as shown in the consolidated statement of cash flows) to the related items in the accounts Current quarter $A 000 Previous quarter $A 000
5.1 Bank balances 5,647 10,989
5.2 Call deposits 1,417 1,805
5.3 Bank overdrafts
5.4 Other (term deposit) 15,647 13,528
5.5 Cash and cash equivalents at end of quarter (should equal item 4.6 above) 22,711 26,322
6. Payments to related parties of the entity and their associates Current quarter $A 000
6.1 Aggregate amount of payments to related parties and their associates included in item 1 127
6.2 Aggregate amount of payments to related parties and their associates included in item 2
Note: if any amounts are shown in items 6.1 or 6.2, your quarterly activity report must include a description of, and an
explanation for, such payments.
The amount at 6.1 includes payment of Non-Executive Directors fees and
Executive Directors salary
Quarterly cash flow report for entities subject to Listing Rule 4.7B
7. Financing facilities Note: the term facility includes all forms of financing arrangements available to the entity. Add notes as necessary for an understanding of the sources of finance available to the entity. Total facility amount at quarter end $A 000 Amount drawn at quarter end $A 000
7.1 Loan facilities
7.2 Credit standby arrangements
7.3 Other (please specify)
7.4 Total financing facilities
7.5 Unused financing facilities available at quarter end
7.6 Include in the box below a description of each facility above, including the lender, interest rate, maturity date and whether it is secured or unsecured. If any additional financing facilities have been entered into or are proposed to be entered into after quarter end, include a note providing details of those facilities as well.
N/A
8. Estimated cash available for future operating activities $A 000
8.1 Net cash from / (used in) operating activities (item 1.9) (3,336 )
8.2 Cash and cash equivalents at quarter end (item 4.6) 22,711
8.3 Unused finance facilities available at quarter end (item 7.5)
8.4 Total available funding (item 8.2 + item 8.3) 22,711
8.5 Estimated quarters of funding available (item 8.4 divided by item 8.1) 6.81
Note: if the entity has reported positive net operating cash flows in item 1.9, answer item 8.5 as N/A . Otherwise, a figure for the estimated quarters of funding available must be included in item 8.5.
8.6 If item 8.5 is less than 2 quarters, please provide answers to the following questions:
8.6.1 Does the entity expect that it will continue to have the current level of net operating cash flows for the time being and, if not, why not?
Answer:
8.6.2 Has the entity taken any steps, or does it propose to take any steps, to raise further cash to fund its operations and, if so, what are those steps and how likely does it believe that they will be successful?
Answer:
8.6.3 Does the entity expect to be able to continue its operations and to meet its business objectives and, if so, on what basis?
Answer:
Note: where item 8.5 is less than 2 quarters, all of questions 8.6.1, 8.6.2 and 8.6.3 above must be answered.
Quarterly cash flow report for entities subject to Listing Rule 4.7B
Compliance statement
Date: 22 October 2020
Authorised by: By the board
(Name of body or officer authorising release see note 4)
Last updated: Oct 23, 2020