Full Press Release Details
Immutep Quarterly Activities Report & Appendix 4C
SYDNEY, AUSTRALIA 29 April 2024 Immutep Limited (ASX: IMM;
NASDAQ: IMMP) ( Immutep or the Company ), a clinical-stage biotechnology company developing novel LAG-3 immunotherapies 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 31 March 2024 (Q3 FY24).
DEVELOPMENT PROGRAM FOR CANCER
TACTI-002 (KEYNOTE-PN798) Phase II clinical trial in 1L NSCLC
The TACTI-002 trial is ongoing with Immutep continuing to follow patients with 1L NSCLC (Part A) where,
encouragingly, a median Overall Survival has not yet been reached in patients with high PD-L1 expression (TPS 50%). As previously reported at ESMO 2023, excellent median Overall Survival rates
were seen across all levels of PD-L1 expression, including in patients expressing any PD-L1 (patients with a Tumor Proportion Score [TPS] of >1%) and patients
with low PD-L1 expression (TPS 1-49%), with 35.5 months and 23.4 months reported respectively. Immutep has previously reported final data from Parts B and C of the TACTI-002 trial.
TACTI-003 (KEYNOTE-PNC34) Phase IIb clinical trial
The TACTI-003 multicenter Phase IIb trial evaluating efti in combination with MSD s anti-PD-1 therapy KEYTRUDA (pembrolizumab) is ongoing with a total of 171 first line head and neck squamous cell
carcinoma (1L HNSCC) patients enrolled. Cohort A evaluating efti in combination with KEYTRUDA as compared to KEYTRUDA monotherapy
(randomised) involves 138 patients with PD-L1 positive (Combined Positive Score [CPS] 1) tumours and Cohort B (non-randomised) includes 33 patients with PD-L1 negative tumours.
Subsequent to quarter end Immutep announced positive preliminary topline results from Cohort B.
The investigational immuno-oncology combination demonstrates an overall response rate (ORR) of 26.9% and disease control rate (DCR) of 57.7% in 26 evaluable patients whose tumours do not express PD-L1
(CPS<1), according to RECIST 1.1, which compares favourably to historical controls.
The final number of evaluable patients in Cohort B is expected to
be higher and additional data, including complete response rate, is expected to be released together with Cohort A data. Data collection, cleaning, and analysis continue for TACTI-003, and the Company expects
to report the primary endpoint (overall response rate according to RECIST1.1) from Cohorts A & B in H1 CY2024.
TACTI-004 Phase III registrational trial in 1L NSCLC
Immutep continued to advance the necessary preparations for the Phase III TACTI-004 trial in first line non-small cell lung cancer (1L NSCLC) during the quarter. Productive interactions with regulatory agencies as well as with other stakeholders and potential partners are ongoing. Immutep expects to announce the trial
design for TACTI-004 in H1 CY2024.
AIPAC-003 Integrated Phase
Immutep announced the first clinical data from the 90mg dosing of efti, the highest dose ever administered to patients, from
patients participating in the safety lead-in of the AIPAC-003 trial in metastatic breast cancer (MBC). Data from the six patients in the safety lead-in showed the 90mg dose of efti in combination with paclitaxel is safe and well tolerated. The initial efficacy data was also encouraging, with a 50% overall response rate, including one patient reporting a
complete response (complete disappearance of all lesions), and a 100% disease control rate. The trial has proceeded to the randomised Phase II portion of study consisting of up to 58 evaluable patients who will receive 30mg efti or 90mg efti to
determine the optimal biological dose of efti in combination with paclitaxel. Currently, 34 patients have been dosed in the randomised part. Further updates from AIPAC-003 will be provided in CY2024.
INSIGHT-003 Phase I in non-squamous 1L NSCLC
The investigator-initiated INSIGHT-003 trial continued to enrol patients throughout the quarter, with 38 out of a total
of 50 patients enrolled and safely dosed across six sites in Germany. INSIGHT-003 evaluates a triple combination therapy consisting of efti and an approved standard of care combination of chemotherapy
(carboplatin and pemetrexed) and anti-PD-1 therapy (pembrolizumab) in patients as first line treatment in non-squamous NSCLC
INSIGHT-005 Phase I trial in Urothelial Carcinoma
The first patient in the investigator-initiated INSIGHT-005 trial was enrolled and safely dosed, as announced in
January 2024. The study is evaluating efti and the anti-PD-L1 therapy BAVENCIO (avelumab) in up to 30 patients
with metastatic urothelial cancer and is jointly funded with Merck KGaA, Darmstadt, Germany.
Phase II Trial in Soft Tissue Sarcoma
The investigator-initiated EFTISARC-NEO trial is ongoing with 14
patients now enrolled and safely dosed. The study evaluates efti in combination with pembrolizumab and radiotherapy in up to 40 soft tissue sarcoma (STS) patients in the neoadjuvant (prior to surgery) setting.
IMP761 DEVELOPMENT PROGRAM FOR AUTOIMMUNE DISEASE
is the Company s proprietary preclinical candidate and world s first LAG-3 agonist that aims to treat the underlying cause of multiple autoimmune diseases. Throughout the quarter, Immutep progressed
its pre-clinical development and IND-enabling toxicology studies for IMP761 to evaluate the safety and toxicity of its product candidate before entering first-in-human trials.
Subsequent to quarter end, Immutep entered into an agreement with the Centre for Human Drug Research (CHDR),
a world-class institute in Leiden, the Netherlands specializing in cutting-edge early-stage clinical drug research, to perform a first-in-human clinical study of IMP761,
which it expects to begin mid-CY2024.
GLAXOSMITHKLINE (GSK) - IMP731 (GSK2831781)
As detailed in Immutep s half year report in February 2024, Immutep received from GSK a written notice of termination of its exclusive License and
Research Collaboration Agreement with GSK entered into in 2010 for the development of GSK2831781, a LAG-3 depleting antibody derived from Immutep s IMP731 antibody, targeting autoimmune disease, with an
effective termination date of 30 May 2024. The Company expects no material impact on the financial statements due to the termination.
CORPORATE & FINANCIAL SUMMARY
In February 2024, Anne Anderson was appointed as an independent non-executive director of Immutep
Limited. Ms Anderson has extensive board and leadership experience serving Australian and international companies and brings considerable capability across capital markets, risk management and governance to Immutep s Board.
During the quarter, Immutep continued
to fund the advancement of its clinical trial programs for efti and preclinical program for IMP761 to create value for shareholders. The Company is well funded with a strong cash and cash equivalent balance as at 31 March 2024 of approximately
$95.4 million, giving it an expected cash reach into early CY2026.
Cash receipts from customers in Q3 FY24 were $14k, compared to $38k in Q2 FY24.
The net cash used in G&A activities in the quarter was $0.7 million, compared to $0.8 million in Q2 FY24. Payments of $310k to Related Parties (detailed in Item 6 of the Appendix 4C) comprises
Non-Executive Directors fees and Executive Directors remuneration.
The net cash used in R&D
activities in the quarter was $6.9 million, which is consistent with Q2 FY24. Payment for staff costs was $2.0 million in the quarter compared to $2.2 million last quarter.
Total net cash outflows used in operating activities in the quarter was $9.0 million compared to $5.5 million in Q2 FY24. This difference was mainly
due to the receipt of $3.8 million in R&D tax grants in Q2 FY24.
A copy of the Appendix 4C -Quarterly Cash Flow Report for the quarter is
Immutep is a clinical stage
biotechnology company developing novel LAG-3 immunotherapy for cancer and autoimmune disease. We are pioneers in the understanding and advancement of therapeutics related to Lymphocyte Activation Gene-3 (LAG-3), and our diversified product portfolio harnesses its unique ability to stimulate or suppress the immune response. Immutep is dedicated to leveraging its
expertise to bring innovative treatment options to patients in need and to maximise value for shareholders. For more information, please visit www.immutep.com.
Australian Investors/Media:
Catherine Strong, Citadel-MAGNUS
U.S. Investors/Media:
Chris Basta, VP, Investor Relations and Corporate Communications
+1 (631) 318 4000; chris.basta@immutep.com
announcement was authorised for release by the CEO of Immutep Limited.
Immutep Limited, Level 32, Australia Square, 264 George
Street, Sydney NSW 2000, Australia
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 | 31st March 2024 |
| 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 | 14 | 184 | |||||||
| 1.2 | Payments for | |||||||||
| (a) research and development | (6,893 | ) | (23,490 | ) | ||||||
| (b) product manufacturing and operating costs | ||||||||||
| (c) advertising and marketing | (104 | ) | (381 | ) | ||||||
| (d) leased assets | ||||||||||
| (e) staff costs | (2,006 | ) | (6,544 | ) | ||||||
| (f) administration and corporate costs | (730 | ) | (3,162 | ) | ||||||
| 1.3 | Dividends received (see note 3) | |||||||||
| 1.4 | Interest received | 742 | 2,718 | |||||||
| 1.5 | Interest and other costs of finance paid | (10 | ) | (21 | ) | |||||
| 1.6 | Income taxes paid | |||||||||
| 1.7 | Government grants and tax incentives | 3,774 | ||||||||
| 1.8 | Other (provide details if material) | (409 | ) | |||||||
| 1.9 | Net cash from / (used in) operating activities | (8,987 | ) | (27,331 | ) | |||||
| 2. | Cash flows from investing activities | |||||||||
| 2.1 | Payments to acquire or for: | |||||||||
| (a) entities | ||||||||||
| (b) businesses | ||||||||||
| (c) property, plant and equipment | (3 | ) | (20 | ) | ||||||
| (d) investments | (86 | ) | ||||||||
| (e) intellectual property | (535 | ) | (863 | ) |
| 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 | ||||||||
| (f) other non-current assets | 16 | 16 | ||||||||
| 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 | (37 | ) | (37 | ) | ||||||
| 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 | (559 | ) | (990 | ) | |||||
| 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 | (296 | ) | |||||||
| 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) -refund for Overpayment from shareholder | (55 | ) | (195 7 | ) | |||||
| 3.10 | Net cash from / (used in) financing activities | (55 | ) | (484 | ) |
| 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
| Consolidated statement of cash flows | Current quarter $A 000 | Year to date (9 months) $A 000 | ||||||||
| 4. | Net increase / (decrease) in cash and cash equivalents for the period | |||||||||
| 4.1 | Cash and cash equivalents at beginning of period | 103,735 | 123,418 | |||||||
| 4.2 | Net cash from / (used in) operating activities (item 1.9 above) | (8,987 | ) | (27,331 | ) | |||||
| 4.3 | Net cash from / (used in) investing activities (item 2.6 above) | (559 | ) | (990 | ) | |||||
| 4.4 | Net cash from / (used in) financing activities (item 3.10 above) | (55 | ) | (484 | ) | |||||
| 4.5 | Effect of movement in exchange rates on cash held | 1,280 | 801 | |||||||
| 4.6 | Cash and cash equivalents at end of period | 95,414 | 95,414 | |||||||
| 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 | 11,024 | 44,895 | |||||||
| 5.2 | Call deposits | 49,465 | 49,409 | |||||||
| 5.3 | Bank overdrafts | |||||||||
| 5.4 | Other (provide details if material) -Term deposit | 34,925 | 9,431 | |||||||
| 5.5 | Cash and cash equivalents at end of quarter (should equal item 4.6 above) | 95,414 | 103,735 | |||||||
| 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 | 310 | ||||||||
| 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.
| ASX Listing Rules Appendix 4C (17/07/20) | Page 3 | |
| + See chapter 19 of the ASX Listing Rules for defined terms. |
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) | (8,987 | ) | |||||||
| 8.2 | Cash and cash equivalents at quarter end (item 4.6) | 95,414 | ||||||||
| 8.3 | Unused finance facilities available at quarter end (item 7.5) | |||||||||
| 8.4 | Total available funding (item 8.2 + item 8.3) | 95,414 | ||||||||
| 8.5 | Estimated quarters of funding available (item 8.4 divided by item 8.1) | 10.62 | ||||||||
| 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. |
| ASX Listing Rules Appendix 4C (17/07/20) | Page 4 | |
| + See chapter 19 of the ASX Listing Rules for defined terms. |
Quarterly cash flow report for entities subject to Listing Rule 4.7B
Compliance statement
| Authorised by: | By the Board | |
| (Name of body or officer authorising release see note 4) |
| ASX Listing Rules Appendix 4C (17/07/20) | Page 5 | |
| + See chapter 19 of the ASX Listing Rules for defined terms. |