Full Press Release Details
Immutep Quarterly Activities Report & Appendix 4C
SYDNEY, AUSTRALIA 29 October 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 its activities for the quarter ended 30 September 2024 (Q1 FY25).
EFTI DEVELOPMENT PROGRAM FOR CANCER
TACTI-004 (KEYNOTE-PNC91) 1L NSCLC Phase III Clinical Collaboration with MSD
In July, Immutep received positive feedback from the US Food and Drug Administration (FDA) regarding its planned
TACTI-004 Phase III trial of eftilagimod alfa (efti) in combination with KEYTRUDA (pembrolizumab), MSD s (Merck & Co., Inc., Rahway, NJ,
USA) anti-PD-1 therapy, and histology-based platinum doublet chemotherapy for the treatment of first-line metastatic non-small
cell lung cancer (1L NSCLC), regardless of PD-L1 expression.
The FDA feedback builds on previously received
guidance from the Paul-Ehrlich-Institut and the Spanish Agency for Medicines and Health Products, successfully concluding the preparatory regulatory interactions for the design of this registrational trial. The study will enrol ~750 patients
regardless of PD-L1 expression in order to address the entire 1L NSCLC market eligible for anti-PD-1 therapy.
TACTI-003 (KEYNOTE-C34) Phase IIb clinical trial in 1L HNSCC
TACTI-003 is evaluating efti in combination with MSD s anti-PD-1 therapy KEYTRUDA (pembrolizumab) as first-line treatment of recurrent or metastatic head and neck squamous cell carcinoma patients (1L
HNSCC). The randomized Cohort A portion of the study is evaluating efti in combination with KEYTRUDA as compared to KEYTRUDA monotherapy in patients with PD-L1 positive (Combined Positive Score [CPS] 1)
tumours, whereas Cohort B is evaluating efti in combination with KEYTRUDA in patients with PD-L1 negative tumours (CPS <1).
In July, Immutep reported updated positive efficacy and safety results from Cohort B of the TACTI-003 Phase IIb trial
at an ESMO Virtual Plenary session. In patients with negative PD-L1 expression (CPS <1) in Cohort B, efti in combination with KEYTRUDA achieved a
35.5% objective response
rate (ORR). This is among the highest recorded for a treatment approach not containing chemotherapy in patients with CPS <1. The immuno-oncology combination with efti also attained a high
complete response rate of 9.7%, which compares favourably to a historical control of 0% from anti-PD-1 monotherapy in 1L HNSCC patients with a CPS <1. Additionally,
durability of responses was tracking well.
In September, further data was reported from Cohort A of the TACTI-003
trial in a late-breaking abstract and prestigious Proffered Paper oral presentation at ESMO Congress 2024. At ESMO, late-breaking abstracts are generally reserved for high-quality, new research findings from randomised phase II or phase III trials
with implications for clinical practice or understanding of disease processes. Proffered Papers are oral presentations of original data of superior quality, followed by expert discussion and perspectives.
In patients with PD-L1 positive tumours (CPS 1), efti in combination with KEYTRUDA outperformance was largest
in CPS 20 with 31.0% ORR (34.5% ORR including a partial response recorded after data cut-off date) versus 18.5% ORR for KEYTRUDA monotherapy. Efti in combination with KEYTRUDA led to a high durability
of response of 17.5 months in patients with CPS 1 and the combination continues to have favourable safety profile. Additionally, a statistically significant increase in absolute lymphocyte count, measured as an exploratory biomarker, was seen
in the efti with KEYTRUDA arm indicating an effective efti-induced immune response in this randomised setting.
Immutep will continue to follow the
maturing data from TACTI-003, with the most relevant endpoint of Overall Survival expected in 2025 and engage with regulatory authorities regarding potential paths forward.
TACTI-002 (KEYNOTE-PN798) Phase II clinical trial in 1L NSCLC
Immutep continues to follow patients with first-line non-small cell lung cancer (1L NSCLC), in Part A of the TACTI-002 trial, where excellent median Overall Survival (mOS) rates were seen across all levels of PD-L1 expression. Immutep has previously reported final data from the other
parts of the TACTI-002 trial.
AIPAC-003 Integrated Phase II/III
Subsequent to quarter end, Immutep completed patient enrolment in the randomised Phase II portion of the
AIPAC-003 trial in October. The Phase II portion enrolled 65 metastatic hormone receptor positive (HR+), HER2-negative/low or triple-negative breast cancer patients who had exhausted endocrine therapy
including cyclin-dependent kinase 4/6 (CDK4/6) inhibitors. The patients have been enrolled across 22 clinical sites in Europe and the United States and have been randomised 1:1 to receive either 30mg or 90mg dosing of efti in combination with
paclitaxel to determine the optimal biological dose of efti consistent with the FDA s Project Optimus initiative. Further updates will be provided after data collection, data cleaning and analysis.
INSIGHT-003 Phase I in non-squamous 1L NSCLC
The investigator-initiated INSIGHT-003 trial continued to enrol patients throughout the quarter and they have been
safely dosed across six sites in Germany. Further updates from the trial are anticipated in Q 4 CY2024.
INSIGHT-005 Phase I trial in Urothelial Carcinoma
The INSIGHT-005 trial is evaluating efti and the
anti-PD-L1 therapy BAVENCIO (avelumab) in up to 30 patients with metastatic urothelial cancer. The study is
jointly funded with Merck KGaA, Darmstadt, Germany.
EFTISARC-NEO Phase II Trial in Soft Tissue Sarcoma
New data from the EFTISARC-NEO Phase II investigator-initiated trial of efti in combination with radiotherapy plus
KEYTRUDA (pembrolizumab) for patients with soft tissue sarcoma (STS) will be presented on 14 November at the Connective Tissue Oncology Society (CTOS) 2024 Annual Meeting taking place in
San Diego, California.
IMP761 DEVELOPMENT PROGRAM FOR AUTOIMMUNE DISEASE
In August, Immutep successfully dosed the first participant in the first-in human Phase I trial of IMP761 after
receiving regulatory clearance from the ethics and competent authority in the Netherlands to initiate the study. Safety data from this first-in-human study is
anticipated by the end of the calendar year 2024, with pharmacokinetics and pharmacodynamics data in first half CY2025.
IMP761 is a first-in-class agonist LAG-3 antibody designed to restore balance to the immune system by enhancing the brake function of LAG-3 to silence dysregulated self-antigen-specific memory T cells that cause many autoimmune diseases.
During the quarter, Immutep was granted seven new patents for efti, IMP761 and LAG525 (ieramilimab) in various territories.
Two patents were granted for efti in combination with a PD-1 pathway inhibitor in South Korea and Brazil and one
patent was granted in Mexico for a binding assay for determining MHC Class II binding activity. The assay is used in the characterisation of efti in GMP-grade manufacturing.
New patents were also granted for IMP761 in India and Israel. For LAG525, which is exclusively licensed to Novartis by Immutep, two new patents were granted
in Australia and Taiwan.
CORPORATE & FINANCIAL SUMMARY
Immutep enters the ASX300
Following the September
quarterly review of the S&P Dow Jones Indices, Immutep was added to the S&P/ASX 300 index. Joining the ASX300 recognises the Company s considerable growth over the years, enhances its market visibility and supports investor confidence.
During the quarter, Immutep
continued to advance 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 30 September 2024 of approximately
A$120.3 million. In addition to this cash balance, Immutep has an A$52.0 million bank term deposit, which has been recognised as a short-term investment due to the maturity date of 5-12 months. This
aggregate position of A$172.3 million as at 30 September 2024 gives Immutep an expected cash reach to the end of CY2026.
Cash receipts from customers in Q1 FY25 were $20k. During the quarter, Immutep received a 2,194,918
(~A$3,602,362) research and development (R&D) tax incentive payment in cash from the French Government under its Cr dit d Imp t Recherche scheme and $549k from the Australian government R&D tax rebate.
The net cash used in G&A activities in the quarter was $961k, compared to $1.9 million in Q4 FY24. Payments to Related Parties (detailed in item 6.1
of the Appendix 4C) comprises Non-Executive Directors fees and Executive Directors remuneration of $576 k.
The net cash used in R&D activities during the quarter was $9.5 million, compared to $3.8 million to Q4 FY24. The increase is mainly due to the
increased level of clinical trial activities. Payment for staff costs was $2.8 million in the quarter compared to $2.0 million in Q4 FY24.
Total net cash outflows used in operating activities in the quarter were $8.6 million compared to $7.4 million in Q4 FY24.
For the cash flow used in investing activities, the company invested $32.4 million in bank term deposits with maturity between 5 and 6 months which has
been recognised as a short-term investment.
Net cash outflow from financing activities for the quarter was approximately $373 k including $254k for the
payment of capital raising cost.
A copy of the Appendix 4C -Quarterly Cash Flow Report for the quarter is attached.
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:
+61 (0)406 759 268; catherine.strong@sodali.com
U.S. Investors/Media:
Chris Basta, VP, Investor
Relations and Corporate Communications
+1 (631) 318 4000; chris.basta@immutep.com
This 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 | 30th September 2024 |
| 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 | 20 | 20 | |||||||
| 1.2 | Payments for | |||||||||
| (a) research and development | (9,472 | ) | (9,472 | ) | ||||||
| (b) product manufacturing and operating costs | ||||||||||
| (c) advertising and marketing | (77 | ) | (77 | ) | ||||||
| (d) leased assets | ||||||||||
| (e) staff costs | (2,775 | ) | (2,775 | ) | ||||||
| (f) administration and corporate costs | (961 | ) | (961 | ) | ||||||
| 1.3 | Dividends received (see note 3) | |||||||||
| 1.4 | Interest received | 1,202 | 1,202 | |||||||
| 1.5 | Interest and other costs of finance paid | (11 | ) | (11 | ) | |||||
| 1.6 | Income taxes paid | |||||||||
| 1.7 | Government grants and tax incentives | 4,152 | 4,152 | |||||||
| 1.8 | Other (provide details if material) -Intellectual property management | (671 | ) | (671 | ) | |||||
| 1.9 | Net cash from / (used in) operating activities | (8,593 | ) | (8,593 | ) | |||||
| 2. | Cash flows from investing activities | |||||||||
| 2.1 | Payments to acquire or for: | |||||||||
| (a) entities | ||||||||||
| (b) businesses | ||||||||||
| (c) property, plant and equipment | (1 | ) | (1 | ) |
| Consolidated statement of cash flows | Current quarter $A 000 | Year to date (3 months) $A 000 | ||||||||
| (d) investments -Short term deposit | (32,408 | ) | (32,408 | ) | ||||||
| (e) intellectual property | ||||||||||
| (f) other non-current assets | ||||||||||
| 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 | (32,409 | ) | (32,409 | ) | |||||
| 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 | (254 | ) | (254 | ) | |||||
| 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) | (119 | ) | (119 | ) | |||||
| 3.10 | Net cash from / (used in) financing activities | (373 | ) | (373 | ) |
| Consolidated statement of cash flows | Current quarter $A 000 | Year to date (3 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 | 161,790 | 161,790 | |||||||
| 4.2 | Net cash from / (used in) operating activities (item 1.9 above) | (8,593 | ) | (8,593 | ) | |||||
| 4.3 | Net cash from / (used in) investing activities (item 2.6 above) | (32,409 | ) | (32,409 | ) | |||||
| 4.4 | Net cash from / (used in) financing activities (item 3.10 above) | (373 | ) | (373 | ) | |||||
| 4.5 | Effect of movement in exchange rates on cash held | (72 | ) | (72 | ) | |||||
| 4.6 | Cash and cash equivalents at end of period | 120,343 | 120,343 | |||||||
| 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 | 47,727 | 14,167 | |||||||
| 5.2 | Call deposits | 16,182 | 80,766 | |||||||
| 5.3 | Bank overdrafts | |||||||||
| 5.4 | Other (provide details if material) -Term deposit | 56,434 | 66,857 | |||||||
| 5.5 | Cash and cash equivalents at end of quarter (should equal item 4.6 above) | 120,343 | 161,790 | |||||||
| 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 | 576 | ||||||||
| 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. |
| 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) | (8,593 | ) | |||||||
| 8.2 | Cash and cash equivalents at quarter end (item 4.6) | 120,343 | ||||||||
| 8.3 | Unused finance facilities available at quarter end (item 7.5) | |||||||||
| 8.4 | Total available funding (item 8.2 + item 8.3) | 120,343 | ||||||||
| 8.5 | Estimated quarters of funding available (item 8.4 divided by item 8.1) | 14.00 | ||||||||
| 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. |
Compliance statement