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Immutep(IMMP) - 2022 Q4 - Annual Report
2022-10-31 10:06
Table of Contents UNITED STATES SECURITIES AND EXCHANGE COMMISSION WASHINGTON, D.C. 20549 FORM 20-F (Mark One) ☐ REGISTRATION STATEMENT PURSUANT TO SECTION 12(b) OR (g) OF THE SECURITIES EXCHANGE ACT OF 1934 ☐ SHELL COMPANY REPORT PURSUANT TO SECTION 13 OR 15(d) OF THE SECURITIES EXCHANGE ACT OF 1934 Date of event requiring this shell company report Commission file number 001-35428 OR ☒ ANNUAL REPORT PURSUANT TO SECTION 13 OR 15(d) OF THE SECURITIES EXCHANGE ACT OF 1934 For the fiscal year ended June 30, 20 ...
Immutep (IMMP) presents at Non-Small Cell Lung Cancer (NSCLC) Drug Development Summit - Slideshow
2022-09-29 18:37
| --- | --- | |-------|--------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------| | | | | | | | | A Soluble LAG-3 Protein (Eftilagimod Alpha) with an Anti-PD-1 Antibody (Pembrolizumab): Results of a Phase II Study in NSCLC Frédéric Triebel MD, PhD Non-Small Cell Cancer Drug Development Summit | | | Boston, September 22 nd 2022 | Notice: Forward Looking Statements 2 T ...
Immutep (IMMP) presents TACTI-002 data at ASCO 2022 - Slideshow
2022-06-10 17:02
| --- | --- | --- | |-------|-------------------|---------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------| | | | | | | | | | | | | | | | | | | for | Global Webcast Slides TACTI-002 data presented at ASCO 2022 | | | Webcast Details | | | | Date & Time: | 5.00 pm CDT (Chicago) Monday 6 June 2022/ | | | Speakers: | 8.00 am AEST (Sydney) Tuesday 7 June 2022 Immutep CEO Marc Voigt, CMO/C ...
Immutep (IMMP) Investor Presentation - Slideshow
2022-06-03 15:51
| --- | --- | --- | |-------|-------------------------------------------------------------------------------------|-------| | | | | | | | | | | The global leader in developing LAG-3 therapeutics Corporate Presentation May 2022 | | | | | | (ASX: IMM, NASDAQ: IMMP) Notice: Forward-Looking Statements The purpose of the presentation is to provide an update of the business of Immutep Limited ACN 009 237 889 (ASX:IMM; NASDAQ:IMMP). These slides have been prepared as a presentation aid only and the information the ...
Immutep(IMMP) - 2022 Q2 - Quarterly Report
2022-02-24 11:07
Exhibit 99.1 IMMUTEP LIMITED ABN 90 009 237 889 Appendix 4D Half-Year Financial Report For the Half-Year Ended 31 December 2021 (previous corresponding period: half-year ended 31 December 2020) To be read in conjunction with the 30 June 2021 Annual Report. In compliance with Listing Rule 4.2A. ABN 90 009 237 889 ASX/Media Release (ASX: IMM) 23 February 2022 Appendix 4D Half-Year Financial Report Results for Announcement to the Market Current Reporting Period – Half-year Ended 31 December 2021 Previous Repor ...
Immutep(IMMP) - 2021 Q4 - Annual Report
2021-10-25 12:11
PART I [Key Information](index=6&type=section&id=Item%203%20Key%20Information) This section details significant business, intellectual property, securities, and operating environment risks [Risk Factors](index=7&type=section&id=D.%20Risk%20Factors) The company faces significant financial, operational, and market risks, including historical losses and reliance on future product success - The company has a history of significant operating losses and negative cash flows, with net losses increasing from **A$13.5 million in FY2020 to A$29.9 million in FY2021**[33](index=33&type=chunk) - Immutep is a development-stage biotech company with no products approved for commercial sale and is heavily dependent on the success of its four LAG-3 related product candidates: eftilagimod alpha (IMP321), IMP761, IMP701, and IMP731[34](index=34&type=chunk)[37](index=37&type=chunk)[40](index=40&type=chunk) - The company anticipates requiring additional financing to fund increasing clinical trial costs for IMP321 and other candidates, and there is no guarantee that such funding will be available on acceptable terms[42](index=42&type=chunk)[44](index=44&type=chunk) - The COVID-19 pandemic poses a significant risk, potentially causing delays in clinical trial enrollment, supply chain interruptions, and operational disruptions for the company and its partners[99](index=99&type=chunk)[100](index=100&type=chunk)[102](index=102&type=chunk) - The company's success is dependent on its ability to obtain and maintain patent protection for its product candidates, which involves complex and uncertain legal and scientific challenges[104](index=104&type=chunk)[106](index=106&type=chunk) - The stock price is highly volatile, with ADS prices on NASDAQ ranging from **US$1.03 to US$7.95 in FY2021**. The stock may be considered a "penny stock," which could adversely affect trading[135](index=135&type=chunk)[137](index=137&type=chunk) - As an Australian-incorporated company, it is subject to Australian takeover laws, which may discourage acquisition offers, and U.S. holders of ADSs may face difficulties in enforcing judgments obtained in the United States[163](index=163&type=chunk)[164](index=164&type=chunk) [Information on the Company](index=27&type=section&id=Item%204.%20Information%20on%20the%20Company) Immutep is a biotechnology company developing LAG-3 immunotherapeutic products for cancer and autoimmune diseases [History and Development of the Company](index=27&type=section&id=A.%20History%20and%20Development%20of%20the%20Company) The company transitioned from mining to biotechnology, focusing on LAG-3 immunotherapy, and established key clinical collaborations - Originally a mining company founded in 1987, the company transitioned to biotechnology in 2001. It was renamed from Prima BioMed Ltd to Immutep Limited in November 2017 to reflect its focus on LAG-3 based immunotherapy assets following the 2014 acquisition of Immutep S.A[168](index=168&type=chunk)[169](index=169&type=chunk) - The company has established multiple key clinical collaborations to evaluate its lead product, eftilagimod alpha (efti), in combination with other therapies. These include agreements with Merck & Co. (MSD) for trials combining efti with KEYTRUDA® (TACTI-002 and TACTI-003), Merck KGaA/Pfizer for a trial with avelumab, and CYTLIMIC for trials with a peptide cancer vaccine[170](index=170&type=chunk)[171](index=171&type=chunk)[174](index=174&type=chunk) [Business Overview](index=28&type=section&id=B.%20Business%20Overview) Immutep leads in LAG-3 immunotherapies with four candidates, including lead product IMP321 (efti) in multiple cancer trials, and has partnerships with GSK and Novartis - Immutep is a leader in developing LAG-3 related immunotherapies with four product candidates: IMP321 (eftilagimod alpha), IMP761, IMP701, and IMP731[178](index=178&type=chunk)[181](index=181&type=chunk) - The lead product, IMP321 (efti), is an APC activator being tested in multiple clinical trials for cancer, including a Phase IIb trial for metastatic breast cancer (AIPAC) and Phase II trials for head and neck cancer and non-small cell lung cancer (TACTI-002, TACTI-003)[179](index=179&type=chunk) - The company has partnerships with major pharmaceutical companies for its other LAG-3 candidates: IMP731 is licensed to GSK for autoimmune diseases, and IMP701 (leramilimab) is licensed to Novartis for oncology[180](index=180&type=chunk)[217](index=217&type=chunk)[221](index=221&type=chunk) - IMP761 is an early-stage agonist antibody of LAG-3 being developed in-house for autoimmune diseases, with cell line development and GMP manufacturing steps underway[209](index=209&type=chunk)[210](index=210&type=chunk) - As of June 30, 2021, Immutep owns or co-owns **12 patent families** related to its development candidates. In fiscal year 2021, **9 new key patents** were granted for efti, IMP761, and leramilimab[225](index=225&type=chunk)[233](index=233&type=chunk) - The company operates in a highly competitive biopharma industry, facing competition from large pharmaceutical and biotechnology companies developing treatments for the same indications, including other APC activators and immune-modulating therapies[239](index=239&type=chunk)[242](index=242&type=chunk) [Organizational Structure](index=41&type=section&id=C.%20Organizational%20Structure) This section lists the company's significant wholly-owned subsidiaries across different jurisdictions Significant Subsidiaries of Immutep Limited | Subsidiary | Ownership | Jurisdiction | | :--- | :--- | :--- | | Immutep U.S., Inc. | 100% | Delaware, United States | | Immutep GmbH | 100% | Germany | | Immutep Australia Pty Ltd | 100% | Australia | | Immutep S.A.S. | 100% | France | [Property, Plants and Equipment](index=41&type=section&id=D.%20Property,%20Plants%20and%20Equipment) The company primarily leases office and laboratory spaces in Australia, France, and Germany, owning no significant property - The company does not own significant property or plants. It leases office and laboratory space in Sydney (Australia), Paris (France), Berlin (Germany), and Leipzig (Germany), with lease expiry dates ranging from late 2021 to early 2023[284](index=284&type=chunk)[285](index=285&type=chunk) [Operating and Financial Review and Prospects](index=42&type=section&id=Item%205.%20Operating%20and%20Financial%20Review%20and%20Prospects) The company's financial performance reflects its development stage, with a net loss of A$29.9 million in FY2021, driven by reduced licensing revenue [Operating Results](index=43&type=section&id=A.%20Operating%20Results) The company's net loss significantly increased in FY2021 due to no licensing revenue and a non-cash loss on warrants, despite reduced R&D expenses Comparison of Operating Results (FY2021 vs. FY2020) | Metric | FY 2021 (A$) | FY 2020 (A$) | Change | Reason | | :--- | :--- | :--- | :--- | :--- | | Licensing Revenue | 0 | 7.49 million | ▼ 100% | No milestones recognized in FY2021 | | Other Income | 5.0 million | 9.0 million | ▼ A$4.0M | Decrease in R&D tax incentives and other income | | R&D Expenses | 17.24 million | 22.47 million | ▼ A$5.23M | Decrease in clinical trial costs as TACTI-mel and AIPAC trials wound down | | Net Loss After Tax | 29.90 million | 13.47 million | ▲ 122% | Decrease in revenue and a non-cash loss on the fair value of warrants | Comparison of Operating Results (FY2020 vs. FY2019) | Metric | FY 2020 (A$) | FY 2019 (A$) | Change | Reason | | :--- | :--- | :--- | :--- | :--- | | Licensing Revenue | 7.49 million | 140,000 | ▲ >5000% | GSK milestone payment of GBP 4 million | | R&D Expenses | 22.47 million | 18.47 million | ▲ A$4.0M | Increased clinical trial activities, especially for TACTI-002 and AIPAC | | Net Loss After Tax | 13.47 million | 18.34 million | ▼ 27% | Significant increase in license revenue | [Liquidity and Capital Resources](index=45&type=section&id=B.%20Liquidity%20and%20Capital%20Resources) The company maintains strong liquidity with A$60.6 million cash, primarily funded by equity issuances and government R&D tax incentives - As of June 30, 2021, the company had cash and cash equivalents of **A$60.6 million**, which is considered sufficient to fund operations for more than 12 months[333](index=333&type=chunk)[342](index=342&type=chunk) Summary of Cash Flows (Fiscal Years Ended June 30) | Cash Flow Activity | 2021 (A$) | 2020 (A$) | 2019 (A$) | | :--- | :--- | :--- | :--- | | Net cash used in operating activities | (17,640,342) | (10,839,339) | (15,286,398) | | Net cash used in investing activities | (15,601) | (19,348) | (41,434) | | Net cash provided by financing activities | 52,679,925 | 20,478,081 | 8,012,715 | - Net cash from financing activities in FY2021 was **A$52.7 million**, primarily from two private placements (**A$41.2 million**) and the exercise of warrants (**A$11.3 million**)[341](index=341&type=chunk) - The company has financed its operations primarily through the issuance of equity securities, convertible notes, exercise of warrants, and operating grants[323](index=323&type=chunk) [Trend Information](index=48&type=section&id=D.%20Trend%20Information) R&D expenses are projected to increase due to expanding clinical trials for TACTI-002 and the new TACTI-003 trial, alongside IMP761 preclinical development - R&D expenses are expected to increase. While costs for the AIPAC and TACTI-mel trials are declining as they finalize, costs for the TACTI-002 trial are expected to rise due to patient expansion[345](index=345&type=chunk) - The new randomized, controlled Phase IIb TACTI-003 trial in 1st line head and neck cancer, in collaboration with MSD, will be a significant driver of future R&D expenditure[345](index=345&type=chunk) - Expenses will also increase due to the progression of pre-clinical development for IMP761 and the commencement of newly announced trials with partners[346](index=346&type=chunk) [Directors, Senior Management and Employees](index=50&type=section&id=Item%206.%20Directors,%20Senior%20Management%20and%20Employees) This section details the company's leadership, compensation, and governance, including board structure and employee distribution [Directors and Senior Management](index=50&type=section&id=A.%20Directors%20and%20Senior%20Management) The company's leadership team includes the Chairman, Deputy Chairman, Non-Executive Director, CEO, CSO & CMO, and COO - The company's leadership as of September 1, 2021, includes Dr. Russell Howard (Chairman), Pete Meyers (Deputy Chairman), Grant Chamberlain (Non-Executive Director), Marc Voigt (Executive Director, CEO, CFO), Dr. Frédéric Triebel (CSO & CMO), and Deanne Miller (COO, General Counsel & Company Secretary)[351](index=351&type=chunk)[352](index=352&type=chunk) [Compensation](index=51&type=section&id=B.%20Compensation) Executive remuneration combines fixed and variable components, with an Executive Incentive Plan aligning employee interests with shareholders - Remuneration for executives includes fixed and variable components. The remuneration policy is based on industry practice rather than financial performance, given the company's R&D focus[362](index=362&type=chunk)[364](index=364&type=chunk) Key Management Personnel Compensation for FY2021 (A$) | Name | Position | Total Compensation | | :--- | :--- | :--- | | Dr. R. Howard | Chairman | 143,452 | | Mr. P. Meyers | Deputy Chairman | 113,508 | | Mr. G. Chamberlain | Non-Executive Director | 164,948 | | Mr. M. Voigt | CEO & CFO | 994,587 | | Dr. F. Triebel | CSO & CMO | 858,630 | | Ms. D. Miller | COO | 568,961 | - The company has an Executive Incentive Plan (EIP), approved in 2018, which allows for the grant of performance rights and/or options to eligible employees to align their interests with shareholders[378](index=378&type=chunk) [Board Practices](index=58&type=section&id=C.%20Board%20Practices) The Board comprises four members, mostly independent non-executive directors, and follows Australian corporate governance principles, utilizing NASDAQ exemptions - The Board of Directors consists of **four members**: three non-executive directors (all independent) and one executive director (the CEO)[403](index=403&type=chunk)[408](index=408&type=chunk) - The Board has an Audit Committee and a Remuneration Committee, both composed of the three independent non-executive directors. It does not have a separate Nomination Committee[415](index=415&type=chunk)[416](index=416&type=chunk)[417](index=417&type=chunk) - As a foreign private issuer, the company follows Australian home country corporate governance practices in lieu of certain NASDAQ requirements, such as those related to quorum, director independence meetings, and shareholder approval for certain security issuances[418](index=418&type=chunk)[420](index=420&type=chunk) [Employees](index=62&type=section&id=D.%20Employees) As of June 30, 2021, the company had 28 employees, primarily in R&D, distributed across Australia, France, and Germany - As of June 30, 2021, the company had **28 employees**, an increase from 26 in the prior year. The workforce is distributed as follows: - **By Function**: 20 in R&D, 1 in IP management, and 7 in general management/administration - **By Location**: 7 in Australia, 3 in France, and 18 in Germany[425](index=425&type=chunk) [Share Ownership](index=62&type=section&id=E.%20Share%20Ownership) Directors and executive officers collectively owned 3.07% of outstanding shares as of June 30, 2021 - As of June 30, 2021, all directors and executive officers as a group beneficially owned approximately **22.9 million ordinary shares**, representing **3.07%** of the total shares outstanding[429](index=429&type=chunk)[430](index=430&type=chunk) [Major Shareholders and Related Party Transactions](index=63&type=section&id=Item%207.%20Major%20Shareholders%20and%20Related%20Party%20Transactions) This section identifies major shareholders and confirms the absence of significant related party transactions - As of June 30, 2021, Australian Ethical Investment Ltd (AEF) was the only beneficial owner of **5% or more** of ordinary shares, holding **5.56%**. Its ownership later fell to **4.89%** as of July 30, 2021[431](index=431&type=chunk)[432](index=432&type=chunk) - The Bank of New York Mellon (BNYM), as the depositary for the ADR program, held a relevant interest in **32.82%** of ordinary shares as of July 30, 2021[433](index=433&type=chunk) - On July 30, 2021, FIL Limited became a substantial holder with **6.21%** ownership following participation in a placement[434](index=434&type=chunk) - The company confirms that there were no related party transactions during fiscal years 2021, 2020, and 2019[438](index=438&type=chunk) [Financial Information](index=63&type=section&id=Item%208.%20Financial%20Information) This section confirms audited financial statements, absence of significant legal proceedings, and the company's policy of retaining earnings for growth - The audited consolidated financial statements for the fiscal years ended June 30, 2021, 2020, and 2019 are included in Item 18 of this Annual Report[440](index=440&type=chunk) - The company is not currently involved in any legal or arbitration proceedings that could have a significant effect on its financial position[441](index=441&type=chunk) - Immutep has never paid cash dividends and does not anticipate paying any in the foreseeable future, intending to retain earnings for business growth[442](index=442&type=chunk) [The Offer and Listing](index=64&type=section&id=Item%209.%20The%20Offer%20and%20Listing) The company's ordinary shares trade on the ASX under "IMM", while its ADSs trade on NASDAQ Global Market under "IMMP" - The company's ordinary shares are traded on the Australian Securities Exchange (ASX) under the ticker symbol "IMM"[444](index=444&type=chunk) - The company's American Depositary Shares (ADSs) are traded on the NASDAQ Global Market under the ticker symbol "IMMP"[444](index=444&type=chunk)[446](index=446&type=chunk) [Additional Information](index=64&type=section&id=Item%2010.%20Additional%20Information) This section details the company's corporate structure, material contracts, and regulatory environment, including Australian exchange controls and U.S. tax implications [Memorandum and Articles of Association](index=64&type=section&id=B.%20Memorandum%20and%20Articles%20of%20Association) The company's Constitution, amendable by special resolution, defines director powers and shareholder voting rights - The company's constituent document is a Constitution, which can be amended by a special resolution of shareholders (**75% vote**)[451](index=451&type=chunk) - Directors' powers include managing the business, borrowing money, and issuing debentures. However, significant changes to the nature of the business or disposal of the main undertaking require shareholder approval[453](index=453&type=chunk)[461](index=461&type=chunk) - Holders of ordinary shares have one vote per share on a poll. A quorum for a shareholder meeting consists of at least two shareholders present in person or by proxy[464](index=464&type=chunk)[465](index=465&type=chunk) [Material Contracts](index=67&type=section&id=C.%20Material%20Contracts) A key material contract is the Clinical Trial Collaboration and Supply Agreement with Merck for the TACTI-003 trial - On March 15, 2021, the company entered into a Clinical Trial Collaboration and Supply Agreement with Merck to evaluate eftilagimod alpha (efti) in combination with KEYTRUDA® in a new Phase IIb clinical trial (TACTI-003) for 1st line Head and Neck Squamous Cell Carcinoma (HNSCC)[475](index=475&type=chunk) [Exchange Controls](index=67&type=section&id=D.%20Exchange%20Controls) Australia has largely abolished exchange controls, but foreign acquisitions exceeding certain thresholds require government approval - Australia has largely abolished exchange controls, and the Australian dollar is freely convertible. However, certain payments to non-residents must be reported[476](index=476&type=chunk) - Under the Foreign Acquisitions and Takeovers Act, foreign persons are generally prohibited from acquiring **20% or more** of a company with assets over **A$266 million** without approval from the Australian Treasurer. A **40%** aggregate foreign ownership threshold also applies[479](index=479&type=chunk)[481](index=481&type=chunk) [Taxation](index=69&type=section&id=E.%20Taxation) Australian tax rules for ADS holders include withholding tax on dividends, while U.S. holders face potential adverse consequences if the company is classified as a PFIC - For Australian tax purposes, ADS holders are treated as owners of the underlying ordinary shares. Unfranked dividends paid to non-Australian residents are subject to withholding tax (generally **15%** for U.S. residents)[489](index=489&type=chunk)[492](index=492&type=chunk) - Non-Australian residents are generally not subject to Australian capital gains tax on the disposal of shares unless they hold **10% or more** of the company and the company's value is principally from Australian real property[493](index=493&type=chunk) - For U.S. federal income tax purposes, there is a risk the company may be classified as a Passive Foreign Investment Company (PFIC), which could result in adverse tax consequences for U.S. Holders, including additional taxes and interest charges on certain distributions and gains[515](index=515&type=chunk)[516](index=516&type=chunk)[517](index=517&type=chunk) [Quantitative and Qualitative Disclosures About Market Risk](index=74&type=section&id=Item%2011.%20Quantitative%20and%20Qualitative%20Disclosures%20About%20Market%20Risk) The company's primary market risk is foreign currency fluctuations, particularly USD and EUR, impacting post-tax loss - The company's primary market risk is foreign currency risk, with significant exposure to the U.S. dollar and European Euro due to international operations and cash holdings[533](index=533&type=chunk) Foreign Currency Exposure (A$) | Currency | June 30, 2021 (A$) | June 30, 2020 (A$) | | :--- | :--- | :--- | | **USD** | | | | Cash in bank | 14,016,277 | 7,444,611 | | Trade and other payables | (690,847) | (589,428) | | **EUR** | | | | Cash in bank | 14,320,386 | 9,243,299 | | Trade and other receivables | 4,312,691 | 1,966,803 | | Trade and other payables | (663,196) | (951,654) | - A sensitivity analysis indicates that a **10%** change in the AUD/USD exchange rate would impact the post-tax loss by approximately **A$1.34 million**, and a **10%** change in the AUD/EUR rate would impact it by approximately **A$1.80 million**[698](index=698&type=chunk)[699](index=699&type=chunk) [Description of Securities Other than Equity Securities](index=74&type=section&id=Item%2012.%20Description%20of%20Securities%20Other%20than%20Equity%20Securities) This section details the company's American Depositary Shares (ADSs), including the 10:1 ratio to ordinary shares and associated depositary fees - Each American Depositary Share (ADS) represents **10 ordinary shares**. This ratio was adjusted from **100:1 to 10:1** after a share consolidation in November 2019[538](index=538&type=chunk) - ADS holders may be required to pay fees to the depositary, The Bank of New York Mellon, for various services. Key fees include: - Up to **US$5.00 per 100 ADSs** for issuance or cancellation - Up to **US$0.05 per ADS** for any cash distribution - An annual fee of up to **US$0.05 per ADS** for depositary services[539](index=539&type=chunk)[542](index=542&type=chunk) PART II [Controls and Procedures](index=77&type=section&id=Item%2015.%20Controls%20and%20Procedures) Management concluded that disclosure controls and internal control over financial reporting were effective as of June 30, 2021 - Management concluded that the company's disclosure controls and procedures were effective as of June 30, 2021[547](index=547&type=chunk) - Based on an evaluation using the COSO 2013 framework, management concluded that the company's internal control over financial reporting was effective as of June 30, 2021[548](index=548&type=chunk) - As an emerging growth company, this annual report does not include an attestation report from the registered public accounting firm on internal control over financial reporting[549](index=549&type=chunk) [Other Information](index=77&type=section&id=Item%2016.%20Other%20Information) This section covers governance and compliance topics, including the audit committee financial expert, code of ethics, and principal accountant fees - The Board has determined that Pete Meyers, a member of the audit committee, qualifies as an audit committee financial expert[553](index=553&type=chunk) - The company has adopted a code of conduct for its directors and senior financial officers, which is available on its website[554](index=554&type=chunk) Principal Accountant Fees (PricewaterhouseCoopers) | Fee Type | Fiscal 2021 (A$) | Fiscal 2020 (A$) | | :--- | :--- | :--- | | Audit fees | 289,202 | 282,580 | | **Total** | **289,202** | **282,580** | - The company, as a foreign private issuer, follows certain Australian home country corporate governance practices instead of specific NASDAQ Stock Market Rules[561](index=561&type=chunk) PART III [Financial Statements](index=79&type=section&id=Item%2018.%20Financial%20Statements) The consolidated financial statements for FY2019-2021, audited by PricewaterhouseCoopers, show total assets of A$82.0 million and a net loss of A$29.9 million in FY2021 Consolidated Balance Sheet Highlights (as of June 30) | Metric | 2021 (A$) | 2020 (A$) | | :--- | :--- | :--- | | Cash and cash equivalents | 60,593,191 | 26,322,047 | | Total Assets | 82,030,533 | 46,597,252 | | Total Liabilities | 8,758,922 | 13,297,907 | | Total Equity | 73,271,611 | 33,299,345 | Consolidated Income Statement Highlights (for the year ended June 30) | Metric | 2021 (A$) | 2020 (A$) | 2019 (A$) | | :--- | :--- | :--- | :--- | | Total revenue and other income | 3,968,133 | 16,499,968 | 7,489,404 | | R&D and IP Expenses | (17,236,780) | (22,472,648) | (18,466,852) | | Loss after income tax | (29,902,624) | (13,468,232) | (18,343,984) | | Basic loss per share (cents) | (5.03) | (3.26) | (5.29) | - The independent auditor, PricewaterhouseCoopers, issued an unqualified opinion on the consolidated financial statements, stating they present fairly, in all material respects, the financial position and results of operations in conformity with IFRS[569](index=569&type=chunk) [Exhibits](index=131&type=section&id=Item%2019.%20Exhibits) This section provides an index of all exhibits filed, including the company's Constitution, ADS Deposit Agreement, material contracts, and required certifications - The report includes a comprehensive list of exhibits, such as the company's Constitution (Exhibit 1.1), the ADS Deposit Agreement (Exhibit 2.1), the Immutep Executive Incentive Plan (Exhibit 4.1), and material contracts like the Clinical Trial Collaboration and Supply Agreement with Merck (Exhibit 4.12)[856](index=856&type=chunk) - Certifications from the Chief Executive Officer and Chief Financial Officer as required by the Sarbanes-Oxley Act (Rules 13a-14(a) and 13a-14(b)) are filed as Exhibits 12.1 and 13.1[857](index=857&type=chunk)
Immutep(IMMP) - 2021 Q2 - Quarterly Report
2021-02-24 00:20
[Results for Announcement to the Market](index=2&type=section&id=Results%20for%20Announcement%20to%20the%20Market) Immutep reported zero revenue and a 233% increase in net loss to AUD 19.8 million for H1 FY2021, primarily due to a non-cash warrant loss, despite Net Tangible Assets per share doubling Key Financial Results | Metric | Change | Percentage | To | Amount (AUD) | | :--- | :--- | :--- | :--- | :--- | | Revenues | Down | 100% | to | AUD 0 | | Other Income | Down | 29.7% | to | AUD 2,260,333 | | Total revenue and other income | Down | 78.6% | to | AUD 2,260,333 | | Loss after tax attributable to members | Up | 233% | to | (AUD 19,844,146) | - The significant increase in loss after tax was mainly due to a non-cash expense of **AUD 8.1 million** from the net change in fair value of warrants and the absence of a milestone payment received in the prior period[2](index=2&type=chunk) Net Tangible Assets per Share | Date | Amount (cents) | | :--- | :--- | | As at 31 December 2020 | 7.22 | | As at 31 December 2019 | 3.15 | - The company did not declare or pay any dividends during the current or previous corresponding period[3](index=3&type=chunk) [Directors' Report](index=4&type=section&id=Directors%27%20Report) The report details Immutep's LAG-3 immunotherapeutic development, clinical trial progress for efti, key collaborations, and a strengthened financial position with a positive outlook [Principal Activities & Review of Operations](index=4&type=section&id=Principal%20Activities%20%26%20Review%20of%20Operations) Immutep, a leader in LAG-3 immunotherapeutics, saw encouraging efti clinical results in H1 FY2021, leading to trial expansions and strengthened pharmaceutical collaborations - Immutep is a leader in developing LAG-3 immunotherapeutic products for cancer and autoimmune disease[9](index=9&type=chunk) - The lead product candidate is eftilagimod alpha ("efti" or "IMP321"), a soluble LAG-3Ig fusion protein in clinical development for cancer treatment, with two other candidates exclusively licensed to major pharmaceutical partners[10](index=10&type=chunk) - Encouraging clinical results prompted the expansion of the TACTI-002 trial and the announcement of a new Phase II trial in 1st line head and neck cancer[14](index=14&type=chunk)[17](index=17&type=chunk) - The company maintained collaborations with five major pharmaceutical companies: Novartis, GSK, MSD (Merck & Co), Merck KGaA, and Pfizer, and entered a new collaboration with LabCorp[15](index=15&type=chunk) [Clinical Trials for Eftilagimod Alpha](index=5&type=section&id=Clinical%20Trials%20for%20Eftilagimod%20Alpha) Efti clinical trials showed promising results, including a **+7.1 month** OS benefit in AIPAC, **36% ORR** in TACTI-002 leading to expansion, and new trials initiated for HNSCC and COVID-19 - AIPAC Phase IIb trial: Reported a promising Overall Survival (OS) trend, with a median survival benefit of **+2.7 months**, and a statistically significant benefit of **+7.1 months** seen in patients under 65[21](index=21&type=chunk)[22](index=22&type=chunk) - TACTI-002 Phase II trial: Reported a **36% Overall Response Rate (ORR)** in both 1st line NSCLC and 2nd line HNSCC cohorts, with some patients achieving a Complete Response, leading to trial expansion by **74 patients** in the 1st line NSCLC group[27](index=27&type=chunk)[28](index=28&type=chunk) - A new randomized, controlled Phase II trial in approximately **160 1st line HNSCC patients** was announced[31](index=31&type=chunk) - Chinese partner EOC Pharma announced a new Phase II trial for efti in metastatic breast cancer following encouraging AIPAC data[34](index=34&type=chunk) - INSIGHT-004 Phase I trial: Showed a **41.7% Partial Response rate** for the combination of efti and avelumab in various advanced solid malignancies[41](index=41&type=chunk) - EAT COVID Phase II trial: An investigator-initiated trial of efti in up to **110 hospitalized COVID-19 patients** was initiated to prevent the development of severe symptoms[42](index=42&type=chunk) [Efti Manufacturing & Preclinical Development](index=7&type=section&id=Efti%20Manufacturing%20%26%20Preclinical%20Development) Immutep is scaling up efti manufacturing from **200L to 2,000L** bioreactors for commercial readiness while advancing preclinical candidate IMP761 for autoimmune diseases - The company is increasing efti's manufacturing process from **200L to 2,000L** capacity bioreactors at WuXi Biologics in China[44](index=44&type=chunk)[45](index=45&type=chunk) - Immutep's partner in China, EOC Pharma, is also upscaling manufacturing of efti to **2,000L** for its own trials[46](index=46&type=chunk) - The preclinical candidate IMP761, an agonist antibody for autoimmune diseases, continued through cell line and other preclinical development stages[47](index=47&type=chunk)[48](index=48&type=chunk) [Partner-Led Development & Collaborations](index=8&type=section&id=Partner-Led%20Development%20%26%20Collaborations) Partners advanced licensed assets, with Novartis conducting **five** LAG525 trials, GSK stopping a Phase II trial but maintaining collaboration, and new partnerships formed with LabCorp and Monash University - Partner Novartis has **five ongoing clinical trials** for LAG525 (derived from IMP701) in multiple cancer indications, involving **over 1,000 patients**[50](index=50&type=chunk) - Partner GSK stopped its Phase II clinical study of GSK2831781 in ulcerative colitis based on a planned interim analysis, but the exclusive license and collaboration with Immutep remain in place[51](index=51&type=chunk)[53](index=53&type=chunk) - A new Licence and Collaboration Agreement was signed with LabCorp to support the development of immuno-oncology products or services[54](index=54&type=chunk) - Immutep and Monash University were awarded a **AUD 671,427** grant to continue their research collaboration into LAG-3 for another three years[55](index=55&type=chunk) [Intellectual Property](index=8&type=section&id=Intellectual%20Property) Immutep strengthened its IP portfolio with **four** new patents, including a US patent for efti in combination with PD-1 inhibitors, and patents for LAG525 and IMP761 - A new US patent was granted protecting combined preparations of efti and a PD-1 pathway inhibitor (e.g., pembrolizumab)[57](index=57&type=chunk) - New US and Australian patents were granted for LAG525, a humanised form of IMP701 out-licensed to Novartis[58](index=58&type=chunk) - The European Patent Office granted a new patent protecting the preclinical product candidate, IMP761, for treating autoimmune diseases[59](index=59&type=chunk) [Financial Performance & Outlook](index=8&type=section&id=Financial%20Performance%20%26%20Outlook) Immutep's cash balance reached **AUD 54.9 million**, providing a runway beyond 2022, despite a net loss of **AUD 19.8 million**, positioning the company for expanded clinical programs Financial Highlights | Metric | Amount (AUD) | | :--- | :--- | | Cash and cash equivalents (31 Dec 2020) | AUD 54.9 million | | Placement completed (Nov 2020) | AUD 29.6 million | | Proceeds from warrant exercises (Dec 2020) | AUD 10.66 million | | Loss after tax (Half-year) | (AUD 19.84 million) | | R&D and IP expenses | AUD 8.4 million | - Research and development expenses **decreased by AUD 3.5 million** to **AUD 8.4 million**, mainly due to the completion of the TACTI-mel trial and the winding down of the AIPAC trial[64](index=64&type=chunk) - The company is in a robust financial and operational position with a **cash runway beyond the end of calendar year 2022** and several significant data read-outs[63](index=63&type=chunk)[67](index=67&type=chunk) [Auditor's Independence Declaration](index=10&type=section&id=Auditor%27s%20Independence%20Declaration) PricewaterhouseCoopers' lead auditor declared no contraventions of auditor independence requirements or professional conduct codes for the H1 FY2021 financial report review - The lead auditor declared no contraventions of the auditor independence requirements of the Corporations Act 2001[71](index=71&type=chunk)[72](index=72&type=chunk) - The auditor also declared no contraventions of any applicable code of professional conduct in relation to the review[71](index=71&type=chunk)[72](index=72&type=chunk) [Half-Year Financial Report](index=11&type=section&id=Half-Year%20Financial%20Report) This section presents the consolidated financial statements for H1 FY2021, including the Statement of Comprehensive Income, Balance Sheet, Statement of Changes in Equity, and Statement of Cash Flows, with detailed notes on accounting policies and financial instruments [Consolidated Statement of Comprehensive Income](index=11&type=section&id=Consolidated%20Statement%20of%20Comprehensive%20Income) The Group reported a net loss of **AUD 19.84 million** for H1 FY2021, a significant increase from the prior period, driven by zero license revenue and a new **AUD 8.06 million** non-cash warrant expense Consolidated Statement of Comprehensive Income | Financial Metric | 31 Dec 2020 (AUD) | 31 Dec 2019 (AUD) | | :--- | :--- | :--- | | License revenue | AUD 0 | AUD 7,366,493 | | Total revenue and other income | AUD 2,260,333 | AUD 10,579,941 | | Net change in fair value of warrants | (AUD 8,057,161) | AUD 619,854 (gain) | | Loss for the half-year | (AUD 19,844,146) | (AUD 5,950,345) | | Total comprehensive loss | (AUD 20,464,897) | (AUD 6,379,326) | | Basic and diluted loss per share (cents) | (3.83) | (1.48) | [Consolidated Balance Sheet](index=12&type=section&id=Consolidated%20Balance%20Sheet) As of 31 December 2020, the Group's financial position strengthened, with total assets increasing to **AUD 76.5 million** and net assets rising to **AUD 60.7 million**, driven by a substantial increase in cash Consolidated Balance Sheet | Balance Sheet Item | 31 Dec 2020 (AUD) | 30 June 2020 (AUD) | | :--- | :--- | :--- | | **Current Assets** | | | | Cash and cash equivalents | AUD 54,880,156 | AUD 26,322,047 | | Total current assets | AUD 62,267,054 | AUD 31,151,874 | | **Non-current Assets** | | | | Intangibles | AUD 13,875,059 | AUD 15,194,807 | | Total assets | AUD 76,473,549 | AUD 46,597,252 | | **Liabilities** | | | | Total current liabilities | AUD 5,214,544 | AUD 3,364,245 | | Total non-current liabilities | AUD 10,568,066 | AUD 9,933,662 | | Total liabilities | AUD 15,782,610 | AUD 13,297,907 | | **Net Assets** | **AUD 60,690,939** | **AUD 33,299,345** | | **Total Equity** | **AUD 60,690,939** | **AUD 33,299,345** | [Consolidated Statement of Changes in Equity](index=13&type=section&id=Consolidated%20Statement%20of%20Changes%20in%20Equity) Total equity increased from **AUD 33.3 million** to **AUD 60.7 million**, driven by **AUD 28.1 million** in equity contributions and **AUD 18.7 million** from warrant exercises, offsetting the **AUD 20.5 million** comprehensive loss Equity Movement (Half-Year to 31 Dec 2020) | Equity Movement | Amount (AUD) | | :--- | :--- | | Balance at 1 July 2020 | AUD 33,299,345 | | Total comprehensive loss for the half-year | (AUD 20,464,897) | | Contribution of equity, net of transaction costs | AUD 28,116,587 | | Exercise of warrants, net of transaction costs | AUD 18,676,142 | | Employee Share based payments | AUD 1,063,762 | | **Balance at 31 December 2020** | **AUD 60,690,939** | [Consolidated Statement of Cash Flows](index=14&type=section&id=Consolidated%20Statement%20of%20Cash%20Flows) The Group's cash increased by **AUD 28.6 million** to **AUD 54.9 million**, driven by **AUD 38.6 million** in financing inflows, despite **AUD 9.0 million** in operating outflows Cash Flow Activity (Half-Year) | Cash Flow Activity | 31 Dec 2020 (AUD) | 31 Dec 2019 (AUD) | | :--- | :--- | :--- | | Net cash outflows from operating activities | (AUD 9,037,013) | (AUD 5,205,594) | | Net cash outflows in investing activities | (AUD 12,128) | (AUD 15,165) | | Net cash inflows from financing activities | AUD 38,631,082 | AUD 9,178,260 | | **Net increase in cash** | **AUD 29,581,941** | **AUD 3,957,501** | | Cash at beginning of half year | AUD 26,322,047 | AUD 16,567,982 | | **Cash at end of half year** | **AUD 54,880,156** | **AUD 20,516,150** | [Notes to the Consolidated Financial Statements](index=15&type=section&id=Notes%20to%20the%20Consolidated%20Financial%20Statements) Notes detail financial statement preparation, confirm going concern status with **AUD 54.9 million** cash, identify Cancer Immunotherapy as the single segment, and disclose financial instruments and equity movements - The directors have assessed the Group's financial position and are confident in its ability to pay its debts and continue as a going concern for at least 12 months[90](index=90&type=chunk) - The Group operates in a single operating segment, identified as Cancer Immunotherapy[94](index=94&type=chunk) - The convertible note liability, measured at fair value, increased to **AUD 9,446,391** as of 31 December 2020[102](index=102&type=chunk) - During the period, US investors exercised **3,238,981 warrants**, providing **AUD 10.66 million** in cash, with the remaining warrant liability at period end being **AUD 958,449**[110](index=110&type=chunk) - The company issued **123,216,687 shares** under an Institutional Placement at **AUD 0.24 per share**, raising **AUD 29,572,005**[120](index=120&type=chunk) [Directors' Declaration](index=28&type=section&id=Directors%27%20Declaration) The Directors declared that the H1 FY2021 financial statements comply with the Corporations Act 2001 and Accounting Standards, provide a true and fair view, and confirm the company's ability to pay its debts - The directors declare that the financial statements give a true and fair view of the consolidated entity's financial position as at 31 December 2020 and its performance for the half-year[132](index=132&type=chunk)[133](index=133&type=chunk) - The directors state there are reasonable grounds to believe that Immutep Limited will be able to pay its debts as and when they become due and payable[132](index=132&type=chunk)[133](index=133&type=chunk) [Independent Auditor's Review Report to the Members](index=29&type=section&id=Independent%20Auditor%27s%20Review%20Report%20to%20the%20Members) PricewaterhouseCoopers' review found no matters suggesting the H1 FY2021 financial report fails to comply with the Corporations Act 2001 or AASB 134, noting the review's limited scope compared to an audit - The auditor concluded that they have not become aware of any matter that makes them believe the half-year financial report does not comply with the Corporations Act 2001[135](index=135&type=chunk) - The review was conducted in accordance with ASRE 2410, which is substantially less in scope than an audit, and therefore no audit opinion is expressed[135](index=135&type=chunk)[140](index=140&type=chunk)
Immutep(IMMP) - 2020 Q4 - Annual Report
2020-09-25 11:53
Table of Contents UNITED STATES SECURITIES AND EXCHANGE COMMISSION WASHINGTON, D.C. 20549 FORM 20-F (Mark One) ☐ REGISTRATION STATEMENT PURSUANT TO SECTION 12(b) OR (g) OF THE SECURITIES EXCHANGE ACT OF 1934 OR ☒ ANNUAL REPORT PURSUANT TO SECTION 13 OR 15(d) OF THE SECURITIES EXCHANGE ACT OF 1934 For the fiscal year ended June 30, 2020 OR ☐ TRANSITION REPORT PURSUANT TO SECTION 13 OR 15(d) OF THE SECURITIES EXCHANGE ACT OF 1934 For the transition period from to OR ☐ SHELL COMPANY REPORT PURSUANT TO SECTION ...
Immutep(IMMP) - 2019 Q4 - Annual Report
2019-09-23 20:09
Table of Contents UNITED STATES SECURITIES AND EXCHANGE COMMISSION WASHINGTON, D.C. 20549 FORM 20-F (Mark One) ☐ REGISTRATION STATEMENT PURSUANT TO SECTION 12(b) OR (g) OF THE SECURITIES EXCHANGE ACT OF 1934 OR ☒ ANNUAL REPORT PURSUANT TO SECTION 13 OR 15(d) OF THE SECURITIES EXCHANGE ACT OF 1934 For the fiscal year ended June 30, 2019 OR ☐ TRANSITION REPORT PURSUANT TO SECTION 13 OR 15(d) OF THE SECURITIES EXCHANGE ACT OF 1934 For the transition period from to OR ☐ SHELL COMPANY REPORT PURSUANT TO SECTION ...
Immutep (IMMP) To Host Eftilagimod Alpha Clinical Development Update Global - Slideshow
2019-04-05 20:09
| --- | --- | |-------------------------|-------------------------------------------------------------------------------------------------------------------------------------------------| | | | | Date & Time Eftilagimod | : Wednesday, April 3, 2019, 7:45am Australian Eastern Standard Time Alpha Clinical Development Update and New Data from Ongoing Melanoma Study | | Register | Tuesday, April 2, 2019, 4:45pm US Eastern Daylight Time : Interested investors can register via the following link to the webcast we ...