Half-Year Report
31 December 2024
Cambium Bio Limited
ASX:CMB
Table of Contents
01 | Directors' report | 2 |
02 | Auditor's Independence Declaration | 5 |
03 | Consolidated Financial Statements | 6 |
04 | Notes to the Consolidated Financial Statements | 10 |
05 | Directors' Declaration | 15 |
06 | Independent Auditor's Review Report | 16 |
07 | Corporate Directory | 18 |
01 Directors' Report
Your Directors present their half-year report for Cambium Bio Ltd (Cambium Bio or the Company) and its controlled entities (the Group) for the half-year ended 31 December 2024, in order to comply with the provisions of the Corporations Act 2001. The Directors report the following information.
1. Directors
The following persons were Directors of Cambium Bio during the whole of the half-year and up to the date of this report, unless otherwise stated.
Name | Position | ||
Barry Sechos | Non-executive Chairman, member of the Remuneration and Nominations Committee, | ||
Chair of the Audit and Risk Committee | |||
Dr Edmund K. Waller, MD, PhD, FACP | CSO and Executive Director | ||
Dr. Sebastian Tseng | Non-Executive Director, Chair of the Remuneration and Nominations Committee, member of | ||
the Audit and Risk Committee | |||
Terence A. Walts, MBA | Executive Director | ||
Dr Chandra Bala A/Prof, MBBS, PhD | Non-Executive Director, joined 22 November 2024 | ||
Dr Chi-Tai Chang. PhD | Non-Executive Director joined 10 October 2024 | ||
Professor Graham Vesey | Executive Director resigned 22 November 2024 | ||
2. Review of operations
Leadership and Governance
During the period, Cambium Bio substantially strengthened its leadership capabilities through strategic appointments across the Board and advisory teams. Dr. Louis Tong, a distinguished expert in ocular immunology and dry eye disease, joined the Scientific Advisory Board in October 2024. As a Senior Consultant at the Singapore National Eye Centre and an internationally renowned clinician-scientist, Dr. Tong brings over two decades of experience in ophthalmology to guide the Company's development of novel dry eye disease therapeutics.
The Board of Directors was enhanced with two significant appointments. In October 2024, Dr. ChiTai Chang joined as a representative of Orient EuroPharma, bringing extensive experience in strategic business development and commercialization of innovative products in the healthcare sector. In November 2024, Clinical A/Prof Chandra Bala was appointed to the Board, contributing significant expertise in ophthalmology and clinical trials as a practicing corneal surgeon and senior partner at PersonalEyes. Professor Graham Vesey retired from the Board effective 22 November 2024, following his valuable contribution since the Company's founding in 2007.
Regulatory Progress
A major milestone was achieved in December 2024 with the U.S. Food and Drug Administration (FDA) granting Fast Track designation to Elate Ocular® for the treatment of moderate to severe dry eye disease. This designation provides several significant advantages, including more frequent FDA interactions, potential eligibility for accelerated approval, and the possibility of rolling review for the future Biologics License Application. The designation represents important validation of both the unmet medical need in dry eye disease and Elate Ocular's potential to address this need.
The Company continued to advance its regulatory strategy during the period, submitting a revised Phase 3 clinical trial protocol to the FDA and requesting a Type D meeting regarding Elate Ocular's Potency Assurance Strategy, scheduled for March 2025.
Clinical Development
Significant progress was made in preparing for the registration-enabling Phase 3 trials of Elate Ocular®. The Company successfully developed and qualified the Elate Ocular® Bioactivity assay, representing an important milestone in the Chemistry, Manufacturing, and Controls (CMC) program. Work continued with the selected Contract Development and Manufacturing Organisation (CDMO) to prepare for cGMP investigational drug manufacturing, with activities progressing according to schedule.
The Company advanced its preparations for Phase 3 clinical trials, conducting a comprehensive evaluation of potential Contract Research Organizations (CROs) and shortlisting several leading candidates for the execution of the trials. The Company remains on track to initiate dosing of the first patient in mid-2025.
Half-Year Report - 31 December 2024 | 2 |
01 Directors' Report
Financial Position
Cambium Bio successfully completed a A$3.0 million capital raising in December 2024 at A$0.4637 per share, demonstrating strong support from both new and existing investors. The raise included a A$1.75 million strategic investment from Zheng Yang Biomedical Technology, A$0.17 million from Cambium Bio directors, and A$1.03 million from Australian institutional and sophisticated investors.
As of 31 December 2024, the Company held cash reserves of A$548k. A further payment of A$0.15 million was received in February 2025, with the remaining A$1.92 million expected to be received following shareholder approval at the General Meeting scheduled for 4 March 2025. The proceeds from the capital raising will primarily support the advancement of Elate Ocular® through its registration-enabling Phase 3 clinical trials and provide working capital for ongoing operations.
Outlook
The Company continues to execute its clinical development strategy for Elate Ocular®, with several key milestones anticipated in the first half of 2025, including the FDA Type D meeting regarding the Potency Assurance Strategy, final CRO selection, and initiation of Phase 3 clinical trials.
3. Financial results
Operating results
The Group's operating result for the 6-month period to 31 December 2024 (H1 FY2025) was a loss of $1.73m, compared to a loss of $1.1m for the previous corresponding period (H1 FY2024).
Revenue
Revenue for the 6-month period to 31 December 2024 was $278k, received from AventaCell Biomedical Corp. Ltd., being a royalty payment arising from the sale of products incorporating fibrinogen-depleted human platelet lysate (FD hPL). compared to nil for the previous corresponding period (H1 FY2024),
Other income
The Group's research and development activities are eligible expenditure under the Australian Government tax incentive subject to the successful application for an advance overseas finding.
The R&D tax incentive recognised in the Consolidated Statement of Profit or Loss for the period to 31 December 2024 is nil as the group delayed the lodgement of the application for FY24. (31 December 2023: nil)
Events subsequent to the end of the reporting date
The Company will hold an Extraordinary General Meeting on 4 March 2025 for shareholders to approve the issue of shares to Cambium Bio's directors and related parties who participated in the capital raise undertaken in early December 2024 and the issues of options to Director, Dr Chandra Bala.
There has not arisen in the interval between 31 December 2024 and the date of this report, any other event that would have had any material effect on the Financial Statements at 31 December 2024.
Expenses from continuing operations
Research and Development
Expenditure on research in the half-year period to 31 December 2024 was $1.58m compared to 31 December 2023 of $30k.
The current accounting policy, and to comply with the accounting standards, is that all costs incurred for research are fully expensed. This policy is being continually reviewed as products move toward licensing and commercialisation.
Corporate
Corporate expenses are approximately $669k in half year FY2025 compared to $814k in the previous corresponding period.
Occupancy
Occupancy expenditure is $2.9k in half year FY2025 (31 December 2023: Nil) Cambium Bio paid membership fees for shared office space and rented a parking space in Singapore.
Half-Year Report - 31 December 2024 | 3 |
01 Directors' Report
Cash flows
The net outflow for the period was $2.59m compared to the prior corresponding period inflow 31 December 2023: $148k.
31 Dec 24 | 31 Dec 23 | Movement | |||
$ | $ | $ | |||
Cash flows (used in) / from operating activities | (2,590,587) | 148,254 | (2,738,840) | ||
Cash flows (used in) investing activities | (565,785) | (76,884) | (488,901) | ||
Cash flows (used in) / provided by financing activities | 839,074 | (347,015) | 1,186,089 | ||
Net cash flows | (2,317,298) | (275,645) | (2,041,652) | ||
Operating activities
Net cash outflow from operating activities in H1 FY 2025 is $2.59m, a significant difference on net cash inflow in H1 FY2024 of $148k. This reflects the increase in costs relating to Elate Ocular® development.
Financing activities
$839k cash inflow in financing activities in H1 FY 2025 relates to the capital raise undertaken by Cambium Bio in early December. Investment from some of the investors were received by 31 Dec 2024. The Company is awaiting receipt of further payments from a number of investors comprising directors and related parties which requires shareholder approval at a General Meeting that is scheduled for 4 March 2025.
Comparing to the same period last year, the cash outflow of $347k related to the repayment of the loan from Radium Capital.
Significant changes in state of affairs
There were no further significant changes in the Group's state of affairs during the half year FY25.
Auditor's Independence Declaration
A copy of the auditor's independence declaration, as required under Section 307C of the Corporations Act 2001, is included on page 5 of this report.
Rounding
The amounts shown in this Financial Report, including the Directors' report, have been rounded off, except where otherwise stated, to the nearest dollar as the Company is in a class specified in ASIC Corporations (Rounding in Financial/Directors' Reports) Instrument 2016/191 dated 24 March 2016.
Signed in accordance with a resolution of the Board of Directors:
Barry Sechos
Non-executive Chairman
27 February 2025
Half-Year Report - 31 December 2024 | 4 |
02 Auditor's Independence Declaration
Half-Year Report - 31 December 2024 | 5 |
03 Consolidated Statement of Profit or Loss and Other Comprehensive Income
For the half-year ended 31 December 2024 | Note | 31 Dec 24 | 31 Dec 23 | |||||
$ | $ | |||||||
Revenue | 7 | 277,564 | - | |||||
Other income | 7 | 21,728 | 1 | |||||
Total Income | 299,292 | 1 | ||||||
Royalty expense | (86,677) | - | ||||||
Research and development expenses | (1,576,432) | (29,818) | ||||||
Occupancy expenses | (2,879) | - | ||||||
Corporate expenses | (669,228) | (813,659) | ||||||
Transaction costs related to Mergers and Acquisitions | (16,473) | (324,639) | ||||||
Finance costs | (46,138) | (191,644) | ||||||
Fair value increase on Financial Assets | 13 | 372,618 | - | |||||
Profit on settlement of financial liability | - | 244,862 | ||||||
(Loss) before income tax | (1,725,917) | (1,114,898) | ||||||
Income tax expense | - | - | ||||||
(Loss) for the period | (1,725,917) | (1,114,897) | ||||||
Other comprehensive income | 2,764 | |||||||
Total comprehensive (loss) for the period | (1,723,153) | (1,114,897) | ||||||
Earnings per share (post consolidation) | ||||||||
Basic (loss)/earnings per share from continuing operations | 9 | (0.14) | (0.36) | |||||
Diluted (loss)/earnings per share from continuing operations | 9 | (0.14) | (0.36) | |||||
Note: This statement should be read in conjunction with the accompanying notes.
Half-Year Report - 31 December 2024 | 6 |
03 Consolidated Statement of Financial Position
As at 31 December | Note | 31 Dec 24 | 30 Jun 24 | |||||
$ | $ | |||||||
Current assets | ||||||||
Cash and cash equivalents | 547,650 | 2,864,948 | ||||||
Trade and other receivables | 189,545 | 256,928 | ||||||
R&D tax incentive receivable | - | - | ||||||
Other current assets | 106,243 | 78,039 | ||||||
Total current assets | 843,438 | 3,199,915 | ||||||
Non-current assets | ||||||||
Property, plant and equipment | 4,570 | - | ||||||
Other Financial Assets | 13 | 373,315 | 2 | |||||
Intangible asset | 2,449,464 | 2,449,464 | ||||||
Total non-current assets | 2,827,349 | 2,449,465 | ||||||
Total assets | 3,670,787 | 5,649,381 | ||||||
Current liabilities | ||||||||
Trade & other payables | 1,463,033 | 2,323,321 | ||||||
Provisions | - | 81,409 | ||||||
R&D tax incentive payable | 56,029 | - | ||||||
Total current liabilities | 1,519,062 | 2,404,730 | ||||||
Non-current liabilities | ||||||||
Financial liabilities | 472,838 | 468,320 | ||||||
Total non-current liabilities | 472,838 | 468,320 | ||||||
Total liabilities | 1,991,900 | 2,873,050 | ||||||
Net assets | 1,678,887 | 2,776,331 | ||||||
Equity | ||||||||
Issued capital | 10 | 44,257,819 | 43,632,110 | |||||
Accumulated losses | (44,472,754) | (42,746,837) | ||||||
Reserves | 1,893,822 | 1,891,058 | ||||||
Total equity | 1,678,887 | 2,776,331 | ||||||
Note: This statement should be read in conjunction with the notes to the financial statements
Half-Year Report - 31 December 2024 | 7 |
03 Consolidated Statement of Changes in Equity
For the half-year ended | Share | Reserves | Accumulated | Total | ||||||
capital | losses | equity | ||||||||
31 December | $ | |||||||||
$ | $ | $ | ||||||||
Balance at 1 July 2023 | 38,618,762 | 1,843,286 | (40,587,006) | (124,958) | ||||||
Loss for the period | - | - | (1,114,897) | (1,114,897) | ||||||
Employee share-based payment options issued | - | 143,706 | - | 143,706 | ||||||
Employee share-based payment options forfeited | - | - | - | - | ||||||
Balance at | 38,618,762 | 1,986,992 | (41,701,903) | (1,096,149) | ||||||
31 December 2023 | ||||||||||
Balance at 1 July 2024 | 43,632,110 | 1,891,058 | (42,746,837) | 2,776,331 | ||||||
Loss for the period | - | - | (1,725,917) | (1,725,917) | ||||||
Other comprehensive income | 2,764 | - | 2,764 | |||||||
Issue of share capital | 625,709 | - | - | 625,709 | ||||||
Balance at | 44,257,819 | 1,893,822 | (44,472,754) | 1,678,887 | ||||||
31 December 2024 | ||||||||||
Note: This statement should be read in conjunction with the notes to the financial statements.
Half-Year Report - 31 December 2024 | 8 |
03 Consolidated Statement of Cash Flows
For the half-year ended 31 December | 31 Dec 24 | 31 Dec 23 | ||||
$ | $ | |||||
Operating activities | ||||||
Receipts from royalties | 345,034 | - | ||||
Payments to suppliers and employees | (2,957,349) | (328,439) | ||||
Interest received | 21,728 | - | ||||
R&D tax incentive refund | - | 486,942 | ||||
Finance costs | - | (10,249) | ||||
Net cash (used in) / from operating activities | (2,590,587) | 148,254 | ||||
Investing activities | ||||||
Purchase of property, plant and equipment | (4,960) | (2,272) | ||||
Receipts from sale of property, plant and equipment | - | - | ||||
Transaction costs related to Mergers and Acquisitions | (560,825) | (74,612) | ||||
Net cash (used in) / from investing activities | (565,785) | (76,884) | ||||
Financing activities | ||||||
Proceeds from issue of capital | 625,709 | - | ||||
Cash received in advance of shares being issued net of related costs | 213,365 | |||||
Repayments of third party loans | - | (347,015) | ||||
Net cash (used in) / from financing activities | 839,074 | (347,015) | ||||
Net change in cash and cash equivalents held | (2,317,298) | (275,645) | ||||
Cash and cash equivalents at beginning of period | 2,864,948 | 302,792 | ||||
Cash and cash equivalents at end of period | 547,650 | 27,147 | ||||
Note: This statement should be read in conjunction with the notes to the financial statements.
Half-Year Report - 31 December 2024 | 9 |
04 Notes to the Consolidated Financial Statements
1. Nature of operations
Cambium Bio Limited (ASX:CMB) is a clinical-stage regenerative medicine company headquartered in Sydney, Australia, with a focus on developing innovative biologics for ophthalmology and tissue repair applications. The Company's core technology platform is based on human platelet lysate, which is being leveraged to create a pipeline of novel therapeutics.
Our primary focus is on ophthalmology, with our lead product candidate, Elate Ocular®, being developed to address significant unmet medical needs in the treatment of dry eye disease. Elate Ocular® is advancing towards Phase 3 clinical trials, positioning Cambium Bio at the forefront of regenerative medicine in ophthalmology.
In addition to our ophthalmology program, we continue to develop our mesenchymal stem cell platform, Progenza™, which is being applied to potential therapies for knee osteoarthritis and other tissue repair indications. This diversified approach allows us to explore multiple avenues within the regenerative medicine space.
Following our merger with Cambium Medical Technologies, LLC in April 2024, we have strengthened our position in the regenerative medicine field, combining complementary technologies and expertise. Cambium Bio remains committed to advancing its pipeline through clinical development and commercialisation, with the ultimate goal of providing transformative treatments to improve patient outcomes across multiple indications.
2. General information and basis of preparation
The half-year consolidated financial statements of the Group are for the six months ended 31 December 2024 and are presented in Australian dollars ($), which is the functional currency of the parent company.
These general purpose half-year financial statements have been prepared in accordance with the requirements of the Corporations Act 2001 and AASB 134 Interim Financial Reporting. They do not include all of the information required in annual financial statements in accordance with Australian Accounting Standards and should be read in conjunction with the consolidated financial statements of the Group for the year ended 30 June 2024 and any public announcements made by the Group during the half-year in accordance with continuous disclosure requirements arising under the Australian Securities Exchange Listing Rules and the Corporations Act 2001.
The half-year financial statements have been approved and authorised for issue by the Board of Directors on 27 February 2024.
3. Going concern basis of accounting
The Directors have prepared these financial statements on a going concern basis, which contemplates the continuity of normal business activities and the realisation of assets and settlement of liabilities in the ordinary course of business. In forming this view, the Directors have considered the Group's financial position and future prospects.
Financial Performance and Position
For the half-year ended 31 December 2024, the Group recorded a loss of $1.72 million (2023: $1.11 million) and experienced net
cash outflows from operating activities of $2.59 million (2023: inflow $148,000). As at 31 December 2024, the Group had a net
current asset deficiency of $676,000 (2023: net current assets deficiency $1.1 million).
Future Funding and Operations
The Directors have considered several factors in their assessment of the going concern basis, including:
Capital Raising Progress
The Company has successfully completed a $3.0 million capital raising in December 2024. Whilst an initial tranche has been received, the remaining $1.92 million is subject to shareholder approval at the General Meeting scheduled for 4 March 2025. Based on strong indications of support from major shareholders, the Directors have a reasonable expectation that all resolutions will be approved.
Operational Planning
The secured funding is expected to provide a 12-month operational runway, excluding external clinical trial costs which have not yet been committed. This runway will enable the Company to advance its development programmes while pursuing additional funding options.
Development Strategy
The Company's primary focus remains the initiation of Phase 3 clinical trials for Elate Ocular®, its biologic therapeutic for dry eye disease. The Directors acknowledge that additional capital will be required to fully execute the Phase 3 programme, and the Company is actively exploring various funding options including:
- Further capital raises from existing and new investors
Half-Year Report - 31 December 2024 | 10 |