Immuron(IMRN)

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Immuron(IMRN) - 2023 Q4 - Annual Report
2023-09-28 10:18
Financial Performance - The company reported net losses of A$4,656,421 for the fiscal year ended June 30, 2023, with an accumulated deficit of A$72,055,396[48]. - As of June 30, 2023, the company had A$17,159,764 in cash and cash equivalents, indicating a need for additional financing to support ongoing research and development activities[49]. - The company has never generated revenue from prescription product sales and does not expect significant milestone payments from collaborative partners in the foreseeable future[50]. - The company recognized a receivable of A$398,391 for the fiscal year ended June 30, 2023, related to the Research and Development Tax Incentive program[58]. - As of June 30, 2023, the company's cumulative operating losses have a total potential tax benefit of A$13,156,385, which may be utilized once the company is in a tax profitable position[139]. - The company has never declared or paid dividends on its ordinary shares and does not anticipate doing so in the foreseeable future, indicating a focus on reinvesting earnings for growth[168]. Research and Development - The company is early in its product development efforts, with only two product candidates in early-stage clinical trials and no late-stage clinical trials[39]. - The company may continue to incur operating losses for the foreseeable future as it expands research and development activities for infectious diseases[48]. - The company expects to receive a refundable tax offset of 43.5% on eligible research and development expenditures from the Australian government, which could support ongoing activities[57]. - The company has concentrated its research and development efforts on hyper-immune colostrum technology, with no approved prescription products currently available[125]. - The ongoing research and development activities are subject to regulation by numerous international authorities, and failure to obtain necessary approvals could adversely affect commercialization[114]. - The company is advancing its lead oral polyclonal antibody drug candidates currently in clinical development for the treatment of moderate to severe campylobacteriosis, travelers' diarrhea, and recurrent C. difficile infections (CDI)[188]. Clinical Trials and Regulatory Challenges - Clinical trials are lengthy and costly, with outcomes that may not guarantee future success, potentially impacting the development of product candidates[66]. - The company relies on third parties for conducting preclinical studies and clinical trials, which may lead to delays if these parties do not meet deadlines[68]. - Delays in clinical trials could adversely affect the company's business and future commercialization opportunities[70]. - Regulatory approval processes can take many years and require substantial resources, with no guarantee of success[114]. - The FDA and foreign regulatory authorities have substantial discretion in the approval process, which may lead to delays or denials of product candidates[132]. - Any delay in obtaining required approvals could materially and adversely affect the company's ability to generate revenue from its product candidates[134]. Market and Competition - The company faces competition from entities developing similar product candidates, which could impact its ability to commercialize its products[33]. - The biotechnology industry is highly competitive, with numerous companies potentially developing more effective technologies[83]. - The company faces significant competition from multinational pharmaceutical and biotechnology companies, as well as academic institutions developing similar product candidates[91]. - Multiple companies are developing therapeutics for infectious diseases, including travelers' diarrhea and C. difficile, indicating a crowded market for the company's product candidates[92]. - Market acceptance of the company's products is uncertain, and failure to achieve it could negatively impact revenue generation[85]. Intellectual Property and Legal Risks - The success of the company heavily relies on its ability to protect its intellectual property and proprietary technology, with uncertainties surrounding patent approvals in biotechnology[141]. - The company could incur substantial costs and operational delays if found infringing on third-party patents, which may affect its business and financial results[143]. - The company may need to engage in litigation to enforce its patents or defend against infringement claims, which could be costly and time-consuming[144]. - Patent expiration could lead to increased competition, potentially preventing the company from recovering development costs or profiting from its products[145]. - Changes in patent laws and jurisprudence could weaken the company's ability to protect its products and candidates, impacting its competitive advantage[150]. Product Development and Pipeline - The company currently has only three product candidates in clinical development, which may limit its growth potential if additional candidates are not successfully developed[105]. - The company has limited large-scale manufacturing experience, which may lead to delays in producing sufficient quantities for clinical trials, adversely affecting business operations[93]. - The company currently lacks the capacity to manufacture its product candidates on a commercial scale, which may hinder commercialization efforts[112]. - The company has not secured agreements with third-party manufacturers for commercial production, which may hinder its ability to bring products to market[111]. - The company is expanding its differentiated polyclonal-based product pipeline across multiple indications, including collaborations with the U.S. Department of Defense[188]. Sales and Marketing - Travelan sales for fiscal year 2023 reached gross A$1.97 million (net: A$1.80 million), a significant increase from A$792 thousand (net: A$765 thousand) in 2022 and A$166 thousand (net: A$146 thousand) in 2021, indicating a growth trend in product sales[184]. - The company markets its flagship products, Travelan® and Protectyn®, in Australia, with Travelan® also marketed in Canada and the U.S. as a dietary supplement for digestive tract protection[182]. - The company has limited experience in marketing and sales of pharmaceutical products, which may impair its ability to successfully commercialize its products[98]. Funding and Grants - The company received a USD $3.43 million grant from the US Department of Defense to test the efficacy of Travelan® in a controlled human infection model clinical study[191]. - The company received AU$4.8M (US$3.43M) from the Medical Technology Enterprise Consortium (MTEC) for developing a military-strength dosing regimen for Travelan®[208]. Future Outlook - The company intends to retain all available funds and future earnings to support operations and finance growth, which may limit immediate returns for investors[168]. - The company may need to prioritize development resources towards its most promising candidates, potentially at the expense of others[80]. - Retaining key personnel and cultivating academic collaborations is critical for the company's future success[81].
Immuron(IMRN) - 2023 Q4 - Annual Report
2023-06-30 10:08
Content | Chairman's letter | 3 | | --- | --- | | Review of operations and activities | 5 | | Form 20-F | 8 | | Consolidated Financial Statements | 103 | | Auditor's Independence Declaration | 175 | | Independent Auditor's Report | 176 | | Shareholder Information | 181 | | Corporate Directory | 183 | Exhibit 99.1 Corporate Governance Immuron Limited and its Board of Directors are committed to implementing and achieving an effective corporate governance framework. Our Corporate Governance Statement can be fo ...
Immuron(IMRN) - 2023 Q2 - Quarterly Report
2023-02-28 20:04
Exhibit 99.1 nuron 31 DECEMBER 2022 HALF YEAR REPORT | | 31 December | 31 December | | --- | --- | --- | | | 2022 | 2021 | | | Cents | Cents | | Net tangible asset backing (per share) | 9.25 | 10.51 | The calculation of net tangible assets excludes right-of-use assets arising from AASB 16 Leases. Explanation of results An explanation of the key financial elements contributing to the revenue and result above can be found in the review of operations included within the directors' report. Distributions No divi ...
Immuron(IMRN) - 2022 Q4 - Annual Report
2022-09-09 10:24
UNITED STATES SECURITIES AND EXCHANGE COMMISSION Washington D.C. 20549 FORM 20-F ☐ 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, 2022 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 13 OR 15(d) OF THE SECURITIES ...
Immuron(IMRN) - 2022 Q4 - Earnings Call Presentation
2022-09-07 03:59
y n o e s u l a n o s r e p r o F 11 Immuron INVESTOR PRESENTATION FY22 RESULTS & BUSINESS UPDATE 31 AUGUST, 2022 Steven Lydeamore - CEO NASDAQ: IMRN ASX: IMC EXECUTIVE SUMMARY y n o e s u l a n o s r e p r o F 22 Immuron Ltd (ASX:IMC) (NASDAQ:IMRN) is a globally integrated biopharmaceutical company focused on developing, and commercialising, oral immunotherapeutics for the treatment of gut mediated diseases | --- | --- | --- | |--------------------|-------------|-------------------------------------------- ...
Immuron(IMRN) - 2022 Q4 - Earnings Call Transcript
2022-09-07 03:53
Financial Data and Key Metrics Changes - The company reported a market capitalization of $20.5 million as of August 23, 2022, with cash and equivalents of $22.1 million as of July 30, 2022 [4][8] - FY 2023 revenue exceeded budget by 92%, largely driven by the resurgence in global travel [7] - The company achieved a revenue growth of 425% with strong profit margins, indicating a near breakeven point for the commercial side of the business [22] Business Line Data and Key Metrics Changes - The company has two commercial products: Travelan and Protectyn, with Travelan being marketed in Australia, the USA, and Canada [21] - The digestive health market for supplements is over $15 billion, with a specific market for traveler's diarrhea valued at $1 billion, growing at 7% [12] - Travelan has a potential sales estimate of $83 million in the U.S. and $50 million in Europe, assuming a conservative penetration rate of 15% [13] Market Data and Key Metrics Changes - The company has established distribution relationships in Australia with over 3,500 pharmacies and a significant presence in the U.S. through Passport Health, the largest provider of travel medicine services [10][11] - The company is exploring expansion into new markets, including the U.S. and Canada, for its Protectyn product [11] Company Strategy and Development Direction - The company is focusing on both organic growth and M&A strategies to enhance shareholder value [7][23] - A revised marketing plan for Travelan is underway, with plans to expand sales across target geographies and explore new formulations [24][40] - The company aims to increase market awareness and shareholder communication through regular updates and presentations [43][62] Management's Comments on Operating Environment and Future Outlook - Management expressed disappointment with the current market cap relative to cash reserves and emphasized the importance of strategic spending to grow shareholder value [33] - The company plans to file an IND with the FDA for Travelan and initiate clinical trials, with expectations for topline results by the end of the calendar year [26][44] - Management acknowledged the need for improved marketing and communication strategies to enhance product visibility and market awareness [55][62] Other Important Information - The company has a strong balance sheet with essentially no debt, allowing for strategic investments [23] - Management is considering independent research analyst reports to provide an objective assessment of the company's market potential [59][60] Q&A Session Summary Question: What measures will be taken to get the share price trading above cash backing? - Management acknowledged the current market cap issue and emphasized plans for strategic spending to grow shareholder value [33] Question: Will there be quarterly updates moving forward? - Management confirmed plans for regular webinars and newsletters to improve communication with shareholders [36][37] Question: What is the company doing to increase shareholder value? - Management highlighted the potential for Travelan to exceed $10 million in sales and the exploration of M&A opportunities [39][40] Question: What is the stage of the FDA submission for Travelan? - Management indicated that the company is close to filing the IND for Travelan, with plans for a controlled human infection model study [44][45] Question: What is the status of European patents? - Management provided updates on two European patents, one recently approved and another pending [46] Question: Are there challenges with supply to Amazon? - Management acknowledged supply issues on Amazon and plans to transition to direct sales [51][52] Question: Why has there been little promotion of Travelan at Chemist Warehouse? - Management recognized the need for improved marketing strategies and plans to enhance promotional efforts [54][55] Question: Will the company consider a research analyst report? - Management expressed openness to independent research reports to enhance market awareness [59][60]
Immuron(IMRN) - 2023 Q1 - Quarterly Report
2022-08-31 11:50
Exhibit 99.1 Immuron Limited Appendix 4E 30 June 2022 Immuron Limited Appendix 4E Preliminary Final Report Year ended 30 June 2022 | Name of entity: | Immuron Limited | | --- | --- | | ABN: | 80 063 114 045 | | Year ended: | 30 June 2022 | | Previous period: | 30 June 2021 | Results for announcement to the market | | | | $ | | --- | --- | --- | --- | | Revenue from ordinary activities | Up | 424.9% to | 765,193 | | Loss from ordinary activities after tax attributable to members | Down | (66.0)% to | (2,854, ...
Immuron(IMRN) - 2021 Q4 - Annual Report
2021-10-29 10:18
UNITED STATES SECURITIES AND EXCHANGE COMMISSION Washington D.C. 20549 FORM 20-F ☐ 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, 2021 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 13 OR 15(d) OF THE SECURITIES ...
Immuron(IMRN) - 2020 Q4 - Annual Report
2020-10-28 20:00
UNITED STATES SECURITIES AND EXCHANGE COMMISSION Washington D.C. 20549 FORM 20-F ☐ 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 13 OR 15(d) OF THE SECURITIES ...
Immuron(IMRN) - 2019 Q4 - Annual Report
2019-10-25 23:39
UNITED STATES SECURITIES AND EXCHANGE COMMISSION Washington D.C. 20549 FORM 20-F ☐ 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 13 OR 15(d) OF THE SECURITIES ...