Full Press Release Details
Immutep Quarterly Activities Report & Appendix 4C
SYDNEY, AUSTRALIA 29 April 2022
Immutep Limited (ASX: IMM; NASDAQ: IMMP) ( Immutep or the Company ), a biotechnology company developing novel LAG-3-related
immunotherapy treatments for and autoimmune disease, provides an update on the ongoing development of its product candidates, eftilagimod alpha ( efti ) and IMP761 for the quarter ended 31 March 2022 (Q3 FY22).
Efti Development Program for Cancer
Immutep will report new biomarker and multivariate analysis data from the Phase IIb AIPAC trial in a poster presentation at
ESMO s Breast Cancer Congress in May 2022. The trial evaluated efti in combination with paclitaxel chemotherapy in 227 patients with HER2-negative/HR positive metastatic breast cancer (HR+ MBC). Final Overall Survival results were reported in
November 2021 showing a statistically significant survival benefit in multiple patient subgroups.
- planned registrational trial
In March 2022, Immutep received constructive feedback from the US Food and Drug Administration (FDA) regarding its
clinical development program for efti in MBC. The FDA has supported Immutep s view to continue exploring efti in MBC in a new registrational trial, based on previously reported clinical data, including the final Overall Survival data from the
Phase IIb AIPAC trial. The planned new registrational trial, AIPAC-003, will be based on Immutep s completed Phase IIb AIPAC trial, but with an optimised design and for patients who are likely to benefit
most from the treatment.
The FDA advice follows feedback from the European Medicines Agency (EMA) regarding the efti program received in Q2 of FY22.
Additional regulatory interactions are ongoing, including with the FDA and EMA.
Immutep Limited, Level 33, Australia Square
264 George Street, Sydney NSW 2000
TACTI-003 - Phase IIb clinical trial
Recruitment of 1st line head and neck squamous cell carcinoma (HNSCC) patients into the TACTI-003 trial continued in Q3
FY22. 21 patients out of approximately 154 have been enrolled into the trial. To date, 21 sites have been activated out of 30 sites. 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.
designated KEYNOTE-PN798) - Phase II clinical trial
Immutep reported new interim data from patients with 2nd line metastatic NSCLC from the Phase
II TACTI-002 trial in a poster presentation at ESMO s European Lung Cancer Congress (ELCC) in March 2022. Efti, in combination with pembrolizumab, is showing an encouraging early overall survival rate of
73.7% at the six-month landmark, along with promising interim disease control and tumour growth kinetics. These early signs are supportive that efti may boost the body s immune system to enable
pembrolizumab to work more effectively in NSCLC patients that have progressive disease after 1st line treatment with anti-PD-1 or anti-PD-1 plus chemotherapy.
As announced yesterday, new interim data for 1st line NSCLC patients from TACTI-002 has been selected for a prestigious Oral Presentation at the American Society of Clinical Oncology s (ASCO) 2022 Annual Meeting.
In addition, the Phase IIb TACTI-003 trial design will be presented in a Trial-in-Progress Poster Presentation. ASCO s 2022 Annual Meeting will take place in-person and online from 3-7 June 2022
in Chicago, United States.
INSIGHT-003 - triple combination
Patient recruitment is ongoing for INSIGHT-003 which is an investigator-initiated Phase I trial taking place at the
Institute of Clinical Cancer Research, Krankenhaus Nordwest (IKF), Germany. Already 10 out of a total of 20 patients with various solid tumours are now participating in the trial. The study is evaluating a triple combination therapy consisting of
efti and an existing approved standard of care combination of chemotherapy (carboplatin) and an anti-PD-1 therapy. Interim results from the study are expected to be
IMP761 Development Program for Autoimmune Disease
Immutep is continuing the required preclinical development evaluations of IMP761 prior to entering clinical trials. In addition, the Company s contract
development and manufacturing organisation partner, Northway Biotech is progressing development of a GMP-compliant manufacturing process of IMP761 to prepare the materials needed for the clinical trials.
Intellectual Property
In February 2022, Immutep was
granted a new Australian patent protecting its intellectual property for therapeutic preparations comprising efti and an anti-PD-1 or anti-PD-L1 antibody, such as pembrolizumab, nivolumab, avelumab, durvalumab or atezolizumab.
out-licensing partner for IMP701, Novartis, were granted a new patent by the Japanese Patent Office for LAG525 (IMP701) for the treatment of cancer. The new patent protects pharmaceutical
Level 33, Australia Square
264 George Street, Sydney NSW 2000
compositions comprising LAG525 in a specific dose and for use in a defined treatment regimen. The compositions may also be administered in combination with a second agent such as an anti-PD-1 antibody, an anti-PD-L1 antibody or a chemotherapeutic agent. LAG525 (INN:
ieramilimab) is a humanised form of Immutep s IMP701 antibody.
During the quarter, Immutep was also granted a new patent for its preclinical
autoimmune candidate, IMP761, by the Russian Federal Service for Intellectual Property, known as Rospatent. The patent protects IMP761 and related methods of use in inflammatory and autoimmune disease for the territory of the Russian Federation.
Immutep was deeply saddened by the sudden and unexpected passing of Non-Executive Director Grant Chamberlain in January
2022. Mr Chamberlain was a well-respected and much liked member of the Immutep team. The Board and staff of Immutep extend their sincere condolences to his family and friends.
The Company welcomed distinguished Australian businesswoman, philanthropist and former local government politician, Lucy Turnbull AO as a Non-executive
Director of Immutep in February 2022. Ms Turnbull re-joined Immutep s Board having previously served as its Chairman from October 2010 to November 2017, stepping down from the role due to professional and
personal commitments at the time.
Cash receipts from customers for the quarter were $8k, compared to $14k in Q2 FY22 (i.e., the quarter ended 31 December 2021).
The net cash used in G&A activities in the quarter was $1.6 million compared to $0.2 million in Q2 FY22. The difference compared with the last
quarter is mainly due to the prepayment of certain annual expenses. Payments to Related Parties, detailed in Item 6 of the Appendix 4C cash flow report for the quarter includes $127k 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 $8.13 million, compared to $4.67 million in Q2 FY22. The higher cash outflows in Q3 FY22 were mainly due to increased efti and IMP761 contract manufacturing activities. Total net cash outflows used
in operating activities in the quarter were $10.95 million. In comparison, total net cash outflows from operating activities in Q2 FY22 were $6.06 million.
The Company s cash and cash equivalent balance as at 31 March 2022 was $87.20 million compared to a balance of $99.66 million as at
31 December 2021. Immutep s higher than planned cash balance puts the company in a strong financial position with an expected cash reach based on current estimates of early 2024.
A copy of the Appendix 4C - Quarterly Cash Flow Report for the quarter is attached.
Level 33, Australia Square
264 George Street, Sydney NSW 2000
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 33, Australia Square
264 George 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 | 31 March 2022 |
| 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 | 8 | 78 | ||||||
| 1.2 Payments for | ||||||||
| (a) research and development | (8,125 | ) | (19,627 | ) | ||||
| (b) product manufacturing and operating costs | ||||||||
| (c) advertising and marketing | (106 | ) | (316 | ) | ||||
| (d) leased assets | ||||||||
| (e) staff costs | (1,187 | ) | (3,328 | ) | ||||
| (f) administration and corporate costs | (1,592 | ) | (2,781 | ) | ||||
| 1.3 Dividends received (see note 3) | ||||||||
| 1.4 Interest received | 52 | 182 | ||||||
| 1.5 Interest and other costs of finance paid | (14 | ) | (23 | ) | ||||
| 1.6 Income taxes paid | ||||||||
| 1.7 Government grants and tax incentives | 12 | 3,434 | ||||||
| 1.8 Other (provide details if material) | ||||||||
| 1.9 Net cash from / (used in) operating activities | (10,952 | ) | (22,381 | ) | ||||
| 2. Cash flows from investing activities | ||||||||
| 2.1 Payments to acquire or for: | ||||||||
| (a) entities | ||||||||
| (b) businesses | ||||||||
| (c) property, plant and equipment | (10 | ) | (16 | ) | ||||
| (d) investments | ||||||||
| (e) intellectual property | ||||||||
| (f) other non-current assets | (13 | ) | (38 | ) |
| 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) | 15 | 15 | ||||||
| 2.6 Net cash from / (used in) investing activities | (8 | ) | (39 | ) | ||||
| 3. Cash flows from financing activities | ||||||||
| 3.1 Proceeds from issues of equity securities (excluding convertible debt securities) | 52,975 | |||||||
| 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 | (2,427 | ) | ||||||
| 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) | (44 | ) | (141 | ) | ||||
| 3.10 Net cash from / (used in) financing activities | (44 | ) | 50,407 | |||||
| 4. Net increase / (decrease) in cash and cash equivalents for the period | ||||||||
| 4.1 Cash and cash equivalents at beginning of period | 99,656 | 60,593 | ||||||
| 4.2 Net cash from / (used in) operating activities (item 1.9 above) | (10,952 | ) | (22,381 | ) |
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 | ||||||
| 4.3 Net cash from / (used in) investing activities (item 2. 6 above) | (8) | (39) | ||||||
| 4.4 Net cash from / (used in) financing activities (item 3.10 above) | (44) | 50,407 | ||||||
| 4.5 Effect of movement in exchange rates on cash held | (1,456) | (1,384) | ||||||
| 4.6 Cash and cash equivalents at end of period | 87,196 | 87,196 | ||||||
| 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 | 56,970 | 39,947 | ||||||
| 5.2 Call deposits | 29,924 | 59,407 | ||||||
| 5.3 Bank overdrafts | ||||||||
| 5.4 Other (provide details if material) | ||||||||
| -Term deposit | 302 | 302 | ||||||
| -Restricted cash (Advance payment from shareholder for SPP) | ||||||||
| 5.5 Cash and cash equivalents at end of quarter (should equal item 4.6 above) | 87,196 | 99,656 |
| 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 remuneration.
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) | (10,952 | ) | ||
| 8.2 Cash and cash equivalents at quarter end (item 4.6) | 87,196 | |||
| 8.3 Unused finance facilities available at quarter end (item 7.5) | ||||
| 8.4 Total available funding (item 8.2 + item 8.3) | 87,196 | |||
| 8.5 Estimated quarters of funding available (item 8.4 divided by item 8.1) | 7.96 |
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
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?