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ASX/Media Release IMMUTEP QUARTERLY ACTIVITIES REPORT & APPENDIX 4C Highlights Safely dosed the last HNSCC patient for Stage 2 of Part C of the TACTI-002 Phase II study (also designated KEYNOTE-798) Initiated enrolment o

Key Takeaway: IMMUTEP QUARTERLY ACTIVITIES REPORT & APPENDIX 4C SYDNEY, AUSTRALIA 19 April 2021 Immutep Limited (ASX: IMM; NASDAQ: IMMP) ( Immutep or the Company ), a biotechnology company developing novel immunotherapy treatments for cancer and autoimmune disease, provides an update on the

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IMMUTEP QUARTERLY ACTIVITIES REPORT & APPENDIX 4C
SYDNEY, AUSTRALIA 19 April 2021 Immutep Limited
(ASX: IMM; NASDAQ: IMMP) ( Immutep or the Company ), a biotechnology company developing novel immunotherapy treatments for cancer and autoimmune disease, provides an update on the ongoing development of its product candidates,
eftilagimod alpha ( efti or IMP321 ) and IMP761, and the activities of its partners for the quarter ended March 31, 2021.
We continue to lead the world in the development of different LAG-3 related therapies, with a robust pipeline of
exciting clinical stage programs and promising data. Throughout the quarter ended 31 March 2021, we have been extremely active advancing and expanding upon these clinical programs, building upon our data generated last year said Marc
Voigt, CEO of Immutep. We are well-positioned for long-term success, as we have a steady stream of positive data advancing our clinical studies, and decades of experience across our clinical team, which includes the discoverer of the LAG-3 immune control mechanism, as well as a strengthened balance sheet.
There has recently been broad
industry coverage of positive Phase II/III data from another company s LAG-3 program to treat melanoma, which we re pleased to say further validates targeting the
LAG-3 pathway to enhance the immune response. While they have additional data to announce, what has been discussed to-date further supports our knowledge of the LAG-3 mechanism and is in line with our MSD collaboration to develop a combination of KEYTRUDA with efti. This year is shaping up to be an exciting period
for the clinical development of LAG-3 therapies, added Dr. Frederic Triebel, CSO/CMO of Immutep.
Efti Development Program Updates
Immutep recently further strengthened its IP profile for lead active immunotherapy candidate efti, which is a soluble LAG-3 fusion protein (LAG-3Ig). In particular, in March 2021, the United States Patent & Trademark Office granted a new patent number 10,940,181, which is entitled
Combined Preparations for the Treatment of Cancer or Infection . The patent was filed as a divisional application and follows the grant of the parent patent announced on 30 December 2020. The claims of this new patent build on the
protection provided by
Immutep Limited, Level 12, 95 Pitt
Street, Sydney NSW 2000
the parent patent and are patent protecting Immutep s methods of treating cancer by administering efti and a PD-1 pathway inhibitor: either
pembrolizumab (KEYTRUDA ) or nivolumab. The expiry date of the patent is 20 January 2036 (including a patent term adjustment of 12 days).
TACTI-002 (Two Active Immunotherapies, also designated KEYNOTE-798)
- Phase II clinical trial
The TACTI-002 study is evaluating the combination of efti
with KEYTRUDA (pembrolizumab), the anti-PD-1 therapy from Merck & Co., Inc., Kenilworth, NJ, USA
(known as MSD outside the United States and Canada), in first and second line non-small cell lung cancer (NSCLC) and second line head and neck squamous cell carcinoma (HNSCC). This study is being
conducted in collaboration with MSD, which refers to the study as Keynote-798 .
Patients participate
in one of three parts:
Part A - First Line NSCLC, PD-X naive
Recruitment of an additional 74 first line NSCLC patients was initiated in accordance with Part A of the TACTI-002
collaboration trial expansion plans announced on 19 November 2020, adding to the 36 patients already enrolled prior to the expansion. Immutep and MSD expanded Part A of the TACTI-002 study following the
encouraging results presented at the Society for Immunotherapy of Cancer s (SITC) Congress in November 2020.
Part B - Second Line NSCLC, PD-X refractory
Immutep decided to expand Part B of TACTI-002, under the
study s Simon s two-stage clinical trial design. The Company recently commenced recruitment of an additional 13 second line NSCLC patients, forming Stage 2 of Part B. The decision follows a
preliminary safety and efficacy review by the Data Monitoring Committee and its recommendation, based on the patients recruited in Stage 1 of Part B.
Part C - Second Line HNSCC
The last patient was safely
dosed for Stage 2 of Part C of TACTI-002. This completes recruitment for Part C of the study. The Company continues to be excited by this study, as it recently announced encouraging interim data from TACTI-002 at the SITC 2020 Congress. Specifically, the data from second line HNSCC patients was very robust and forms an excellent basis for additional clinical development in this cancer type.
Additional data from TACTI-002 is expected in H1 2021.
TACTI-003 (Two Active Immunotherapies) - Phase IIb clinical trial -
Immutep will also conduct a new randomised, controlled Phase IIb clinical study in approximately 160 first line HNSCC patients,
which is a more commercially relevant indication than second line HNSCC. This study will evaluate the safety and efficacy of efti when given in combination with MSD s KEYTRUDA , compared
to KEYTRUDA alone. TACTI-003 will be executed in 20+ clinical sites in the United States, Australia and Europe, and study is expected to start in mid-2021.
This is Immutep s second collaboration with MSD for a combination of KEYTRUDA and efti.
Level 12, 95 Pitt Street, Sydney NSW 2000
EAT COVID - Phase II clinical trial
The investigator-initiated Phase II clinical trial being conducted by the University Hospital Pilsen in the Czech Republic advanced from the safety run and
into the randomised portion of the study, which is evaluating efti in up to 110 hospitalised patients with COVID-19.
In January 2021 Immutep reported that the independent Data Safety Monitoring Board (DSMB) had completed a safety
run-in data review of the first six patients from the Phase II clinical trial of Eftilagimod Alpha Treatment by immune modulation in COVID-19 disease (EAT COVID).
Following this data review, the DSMB recommended that the study advance with enrolment for the randomised portion of the study. All six patients (age range, 50-83 years; 2 women and 4 men) received the three
planned 10 mg efti injections and were since discharged from hospital with no adverse events reported.
As announced in January 2021, GSK
stopped its Phase II clinical trial evaluating GSK2831781 (derived from Immutep s IMP731 antibody) in ulcerative colitis based on the assessment of clinical data as part of a planned interim analysis conducted in consultation with the
trial s Data Review Committee. Immutep s collaboration with GSK remains in place and GSK2831781 continues to be under an exclusive license with GSK.
Selected for its in-depth LAG-3 expertise and knowledge, Immutep entered into a Licence and Collaboration Agreement with Laboratory Corporation of America Holdings, known as LabCorp, to
support its development of immuno-oncology products or services in October 2020.
LabCorp co-authored with Bristol
Myers Squibb an abstract released in March 2021 on the distribution and prevalence of LAG-3 expression in samples of melanoma and gastric/gastroesophageal junction cancer for the American Association for
Cancer Research Annual Meeting 2021.
Immutep s other licensing partnerships with Novartis, EOC Pharma and CYTLIMIC continue to progress well.
Financial Summary - Q3 FY21
Cash receipts from customers
for the quarter was $59k, compared to $336k in Q2 (i.e. the quarter ended 31 December 2020).
The net cash used in G&A activities in the quarter
was $242k compared to $1.82 million in Q2. The significant decrease compared with last quarter is mainly due to the prepayment of certain annual expenses in Q2. G&A costs for the quarter includes $125k in payment of Non-Executive Director s fees and Executive Director s remuneration.
The net cash used in Research and
Development activities in the quarter was $1.74 million, compared to $3.18 million in Q2. Year to date cash flow used in R&D activities for the 9 months from July 2020 to March
Level 12, 95 Pitt Street, Sydney NSW 2000
2021 was $7.0 million compared to $16.1 million for the 9 months from July 2019 to March 2020. The decline 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. The cash used in R&D activities is expected to increase with the commencement of the new Phase IIb TACTI-003 clinical trial.
Total net cash outflows used in operating activities in the quarter was $3.05 million.
In comparison, total net cash outflows from operating activities in Q2 was $5.58 million.
The cash and cash equivalent balance as at 31 March
2021 was $51.7 million compared to a balance of $54.9 million as at 31 December 2020.
Immutep is in an excellent financial position with a
cash runway into calendar year 2023 and beyond several significant data read-outs.
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, infectious disease 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, 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 31 March 2021
Consolidated statement of cash flows Current quarter $A 000 Year to date (9 months) $A 000
1. Cash flows from operating activities
1.1 Receipts from customers 59 418
1.2 Payments for
(a) research and development (1,744 ) (7,016 )
(b) product manufacturing and operating costs
(c) advertising and marketing (102 ) (330 )
(d) leased assets
(e) staff costs (1,055 ) (2,891 )
(f) administration and corporate costs (242 ) (2,409 )
1.3 Dividends received (see note 3)
1.4 Interest received 36 87
1.5 Interest and other costs of finance paid (2 ) (10 )
1.6 Income taxes paid
1.7 Government grants and tax incentives 160
1.8 Other (provide details if material) 26
1.9 Net cash from / (used in) operating activities (3,050 ) (11,965 )
2. Cash flows from investing activities
2.1 Payments to acquire or for:
(a) entities
(b) businesses
(c) property, plant and equipment (8 ) (13 )
(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 (9 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 (8 ) (20 )
3. Cash flows from financing activities
3.1 Proceeds from issues of equity securities (excluding convertible debt securities) 29,572
3.2 Proceeds from issue of convertible debt securities
3.3 Proceeds from exercise of options 10,661
3.4 Transaction costs related to issues of equity securities or convertible debt securities (21 ) (1,502 )
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) (39 ) (168 )
3.10 Net cash from / (used in) financing activities (60 ) 38,563
4. Net increase / (decrease) in cash and cash equivalents for the period
4.1 Cash and cash equivalents at beginning of period 54,880 26,322
4.2 Net cash from / (used in) operating activities (item 1.9 above) (3,050 ) (11,965 )
4.3 Net cash from / (used in) investing activities (item 2.6 above) (8 ) (20 )
ASX Listing Rules Appendix 4C (17/07/20) Page 2
+ See chapter 19 of the ASX Listing Rules for defined terms.
Quarterly cash flow report for entities subject to Listing Rule 4.7B
Last updated: Mar 31, 2021