Immutep Limited — Form 20-F Summary
Reporting period: The filing is an annual report for the fiscal year ended June 30, 2021, with comparisons to fiscal 2020 and 2019. It is not a report for 2020 Q4. Financial statements are in Australian dollars (A$) and prepared under IFRS as issued by the IASB and Australian Accounting Standards.
Business context
Immutep is a development-stage biotechnology company focused on LAG-3 immunotherapies for cancer and autoimmune diseases. Its lead candidate, eftilagimod alpha (efti/IMP321), is in clinical development; IMP761 is preclinical, while IMP701 and IMP731 are licensed to pharmaceutical partners. The company had no approved products or material product-sales revenue and employed 28 people at year-end.
Key financial metrics
| Metric (A$ unless stated) | FY2021 | FY2020 |
|---|---|---|
| License revenue | Nil | 7.49 million |
| Total revenue and other income | 3.97 million | 16.50 million |
| R&D and intellectual-property expenses | 17.24 million | 22.47 million |
| Corporate administrative expenses | 6.28 million | 6.34 million |
| Net loss | 29.90 million | 13.47 million |
| Operating cash flow | (17.64 million) | (10.84 million) |
| Cash and cash equivalents at year-end | 60.59 million | 26.32 million |
| Total assets / total liabilities | 82.03 million / 8.76 million | 46.60 million / 13.30 million |
- Gross and operating margins are not meaningful for this development-stage business; the filing reports losses and no commercial product sales.
- Net loss included an A$8.66 million non-cash loss from fair-value changes in U.S. warrants and an A$1.17 million non-cash fair-value loss on convertible notes. Management states the FY2021 loss excluding the non-cash item it discusses was approximately A$21.24 million.
- Cash increased with financing: net cash provided by financing activities was A$52.68 million, principally share placements and warrant exercises. The company issued 260.5 million ordinary shares during FY2021; 748.2 million shares were outstanding at year-end.
- At June 30, 2021, the balance sheet included a A$2.53 million convertible-note liability, A$0.72 million warrant liability and A$0.29 million lease liability. Seventy-five percent of the original convertible notes had been converted during FY2021; the remaining notes mature in 2025 under their terms.
Changes versus the prior comparable period
- Total revenue and other income fell by A$12.53 million, mainly because FY2020 included a A$7.49 million GSK milestone payment and higher grant receipts. No licensing milestone revenue was recognized in FY2021.
- R&D and intellectual-property expenses declined A$5.24 million as TACTI-mel was completed and AIPAC moved into follow-up. Management expected spending to rise as TACTI-002 expanded and TACTI-003 advanced.
- Net loss more than doubled, principally reflecting lower licensing income and the warrant fair-value loss; the warrant valuation had produced a gain in FY2020.
- Operating cash use increased A$6.80 million despite lower supplier and employee payments, partly because FY2020 had substantially larger license and grant cash receipts.
Outlook, developments and risks
- Management said year-end cash was expected to fund operations for more than 12 months from the filing date, while also noting substantial additional funding would be needed for longer-term development and commercialization. The company expected continued losses and increasing R&D spending.
- Planned and ongoing work included expanded TACTI-002, randomized Phase IIb TACTI-003 with pembrolizumab in first-line head and neck cancer, and manufacturing scale-up of efti. FDA Fast Track designation was granted for efti in first-line recurrent or metastatic head and neck cancer; this is not marketing approval.
- Reported interim TACTI-002 results included an objective response rate of 41.7% in Part A (first-line NSCLC; intention-to-treat) and 29.7% in Part C (second-line HNSCC; intention-to-treat). Final INSIGHT-004 data showed a 41.7% response rate in 12 patients. These are clinical-trial results, not evidence of approved or established efficacy.
- GSK stopped its Phase II ulcerative-colitis study of the IMP731-derived candidate after a planned interim analysis; GSK was assessing the data and next steps. This may affect the timing or receipt of related milestones.
- Key risks include clinical failure or delay, patient recruitment, regulatory and manufacturing hurdles, dependence on partners and contractors, uncertain reimbursement and commercialization, continued cash burn and possible need for additional capital. COVID-19 could disrupt trials, supply chains and partner programs. Currency movements also matter: the company reported an FY2021 foreign-exchange loss of A$0.51 million.
- No material contingent liabilities or capital commitments were reported at June 30, 2021, and the company reported no significant legal proceedings. It had never paid cash dividends and did not expect to do so in the foreseeable future.
- After year-end, the company completed further share issuances under its June 2021 financing and Share Purchase Plan; the filing also reports a September 2021 French R&D tax-credit cash receipt of approximately A$3.43 million. These events post-date the reporting period.
Most important facts for investors to verify
- Whether subsequent clinical data support the early efti response signals, particularly in the expanded TACTI-002 and randomized TACTI-003 trials.
- Current cash runway and expected operating burn, including the effect of trial expansion, manufacturing scale-up and post-year-end financing.
- GSK’s conclusions and next steps following its stopped Phase II study, and the status and economics of other partner programs and potential milestone payments.
- The extent to which the A$29.90 million reported loss reflects non-cash fair-value movements; confirm the reconciliation to management’s approximately A$21.24 million adjusted figure.
- Share-count dilution from FY2021 and subsequent placements, warrant exercises, convertible-note conversions and outstanding performance rights.
- Potential COVID-related, foreign-exchange, intellectual-property and third-party manufacturing risks, as well as the assumptions supporting the carrying value of intangible assets.
Audit and controls: PwC issued an unqualified opinion on the IFRS financial statements. Management reported effective disclosure controls and internal control over financial reporting at June 30, 2021; the filing includes no auditor attestation on internal controls because Immutep qualified as an emerging growth company.