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CAMBIUM BIO LIMITED — AGM Information 2023
Nov 29, 2023
64666_rns_2023-11-29_bd5b2a02-1723-4ffa-9f07-6746720ea8e1.pdf
AGM Information
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ASX Announcement 30 November 2023
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AGM Chairman’s Address
Regeneus Ltd (ASX: RGS) ( Regeneus or the Company ), a clinical-stage regenerative medicine company, provides its 2023 Annual General Meeting Chairman’s Address.
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About Regeneus
Regeneus Ltd (ASX:RGS) is a Sydney-based clinical-stage regenerative medicine company using stem cell technologies to develop a portfolio of novel cell-based therapies. Regeneus’ regenerative platform technologies Progenza™ and Sygenus seek to address unmet medical needs in human health markets, focusing on
neuropathic pain, osteoarthritis and various skin conditions. Visit www.regeneus.com.au for more information.
Authorisation & Additional information
This announcement was authorised by the Board of Directors of Regeneus Ltd
16 Goodhope Street, Paddington, NSW 2021 Ph: 1300 995 098 • www.regeneus.com.au • ABN 13 127 035 358
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Regeneus 2023 Annual General Meeting
Chairman’s Address
On behalf of the Board of Directors, I welcome you to Regeneus’ 2023 Annual General Meeting.
Our CEO, Karolis Rosickas, joining us today via zoom, will provide you with an update with his shareholder presentation. Karolis has been with the Company, in the position of CEO, for three years. He has worked hard to position Regeneus to capitalize on its technology primarily through the commercialization of the Company’s lead stem cell technology platform, Progenza.
The Company’s efforts in this regard was dealt a blow in January of this year, when our Japanese partner Kyocera Corporation made the decision to discontinue the development of Progenza for Japan, and terminated the Collaboration and License Agreement with Regeneus. As a consequence of this termination, it was necessary for the Company to substantially reduce its operations to preserve shareholder value.
With no further milestone or other payments forthcoming from Kyocera as a result of the termination of the Collaboration and License Agreement, the Company successfully negotiated the settlement of the outstanding loan to Paddington St Finance in February 2023, making a cash payment of $400,000 and agreeing to transfer the 700,000 shares held by Regeneus in Sangui Bio Pty Ltd, an unlisted biotech company. The transfer of these Sangui Bio shares is subject to shareholder approval today. Once this transfer is complete Regeneus will be debt free.
The loss of our partnership arrangements with Kyocera for the Japanese market was a severe blow to the Company and the Company continues with its search for strategic partners to co-develop Progenza™ in various markets, including the United States, South Korea and China. Unfortunately to date, we have not had any success in this regard.
As foreshadowed at our AGM last year, our CEO has worked hard over the last 12 months exploring M&A options, including bolt-on acquisitions of other regenerative medicine companies and/or merging with other biotechnology companies.
As previously announced, Regeneus signed a non-binding indicative offer letter to merge with Cambium Medical Technologies, LLC. Cambium is a United States-based, clinical-stage regenerative medicine company developing a Phase 3-ready biologic therapeutic, Elate Ocular®, to treat dry eye disease. The negotiation of binding merger documentation is in the final stages, and has taken longer than initially anticipated. Regeneus has previously announced that it expected to complete the merger transaction with Cambium Medical Technologies in calendar 2023. Karolis has worked tirelessly in negotiating the finer points of the merger transaction with Cambium, and I am pleased to say we are in the final stages of negotiations. Once binding merger
16 Goodhope Street, Paddington, NSW 2021 Ph: 1300 995 098 • www.regeneus.com.au • ABN 13 127 035 358
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documentation is signed by the parties, completion of the merger transaction is subject to shareholder approval.
I will now be handing over to our CEO, Karolis Rosickas, who will provide you with a more detailed update on the status of negotiations with Cambium Technologies.
On behalf of our Board, I would like to thank Karolis and my fellow Board members for their hard work and continued support through this very challenging year. And I would also like to thank our shareholders for their ongoing support.
Barry Sechos Chairman
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16 Goodhope Street, Paddington, NSW 2021 Ph: 1300 995 098 • www.regeneus.com.au • ABN 13 127 035 358
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AGM Presentation
Regeneus Ltd ASX:RGS
November 2023
Disclaimer
Summary Information: This Presentation contains summary information about the current activities of Regeneus Ltd (“Regeneus”) as at the date of this Presentation. The information in this Presentation is of a general nature and does not purport to be complete. This Presentation does not purport to contain all the information that an investor should consider when making an investment decision nor does it contain all the information which would be required in a disclosure document or prospectus prepared in accordance with the requirements of the Corporations Act. It should be read in conjunction with Regeneus’ other periodic and continuous disclosure announcements lodged with the ASX, which are available at www.asx.com.au. Neither Regeneus nor its directors, employees or advisers give any warranties in relation to the statements and information in this Presentation.
Not an offer: This Presentation is for information purposes only and is not a prospectus, disclosure document, product disclosure statement or other offering document under Australian law or any other law (and will not be lodged with ASIC or any other regulator and is not approved by or registered with any regulator). The Presentation is not and should not be considered an offer or an invitation to acquire New Shares or any other financial products. This Presentation may not be released or distributed in the United States. This Presentation does not constitute an offer to sell, or a solicitation of an offer to buy, securities in the United States or in any other jurisdiction in which such an offer would be illegal. The New Shares have not been, and will not be, registered under the U.S. Securities Act or the securities laws of any state or other jurisdiction of the United States. Accordingly, the New Shares may not be offered or sold, directly or indirectly, in the United States unless such New Shares have been registered under the U.S. Securities Act, or are offered and sold in a transaction exempt from, or not subject to, the registration requirements of the Securities Act and applicable U.S. state securities laws. The distribution of this Presentation in other jurisdictions outside Australia may also be restricted by law and any such restrictions should be observed. Any failure to comply with such restrictions may constitute a violation of applicable securities laws.
Not financial product advice: This Presentation does not constitute financial product or investment advice (nor tax, accounting or legal advice) nor is it a recommendation to acquire New Shares and does not and will not form any part of any contract for the acquisition of New Shares. This Presentation has been prepared without taking into account the objectives, financial situation or needs of any particular investor. Before making an investment decision, prospective investors should consider the appropriateness of the information having regard to their own objectives, financial situation and needs and seek appropriate advice, including financial, legal and taxation advice appropriate to their jurisdiction. Regeneus is not licensed to provide financial product advice in respect of Regeneus’ shares or any other investment. Cooling off rights do not apply to the acquisition of New Shares.
Financial data: All dollar values are in Australian dollars (“A$”, “AUD”), unless indicated otherwise. Any pro forma financial information included in this Presentation is for illustrative purposes only and is not represented as being indicative of Regeneus’ views on its future financial condition and/ or performance. Any pro forma financial information has been prepared by Regeneus and may not have been prepared in accordance with the measurement and recognition requirements or the disclosure requirements, of applicable accounting standards and other mandatory requirements in Australia.
Future performance: This Presentation contains certain “forward looking statements”. Forward looking statements can generally be identified by the use of forward looking words such as, “expect”, “anticipate”, “likely”, “intend”, “should”, “could”, “may”, “predict”, “plan”, “propose”, “will”, “believe”, “forecast”, “estimate”, “target” “outlook”, “guidance” and other similar expressions within the meaning of securities laws of applicable jurisdictions and include, but are not limited to, indications of, or guidance or outlook on, future earnings or financial position or performance of Regeneus, the outcome and effects of the Offers and the use of proceeds.
The forward looking statements contained in this Presentation are not guarantees or predictions of future performance and involve known and unknown risks and uncertainties and other factors, many of which are beyond the control of Regeneus, and may involve significant elements of subjective judgement and assumptions as to future events which may or may not be correct. Refer to the risks section of this Presentation for a summary of certain general and Regeneus specific risk factors that may affect Regeneus. There can be no assurance that actual outcomes will not differ materially from these forward-looking statements. A number of important factors could cause actual results or performance to differ materially from the forward looking statements, including the risk factors set out in this Presentation. Investors should consider the forward looking statements contained in this Presentation in light of those disclosures. The forward looking statements are based on information available to Regeneus as at the date of this Presentation. Except as required by law or regulation (including the ASX Listing Rules), Regeneus undertakes no obligation to provide any additional or updated information whether as a result of new information, future events or results or otherwise. Indications of, and guidance or outlook on, future earnings or financial position or performance are also forward looking statements.
Effect of rounding: A number of figures, amounts, percentages, estimates, calculations of value and fractions in this Presentation are subject to the effect of rounding. Accordingly, the actual calculation of these figures may differ from the figures set out in this Presentation.
Investment risks: An investment in New Shares is subject to investment and other known and unknown risks, some of which are beyond the control of Regeneus including possible loss of income and principal invested. Regeneus does not guarantee any particular rate of return or the performance of Regeneus, nor does it guarantee the repayment of capital from Regeneus or any particular tax treatment. In considering an investment in Regeneus shares, investors should have regard to (amongst other things) the risks outlined in this Presentation.
Disclaimer: To the maximum extent permitted by law, no representation or warranty, express or implied, is made as to the currency, accuracy, reliability or completeness of information in this Presentation and Regeneus and its advisers, affiliates, related bodies corporate, directors, officers, partners, employees and agents excludes and disclaims all liability, including without limitation for negligence or for any expenses, losses, damages or costs incurred by you as a result of your participation in the Offer and the information in this Presentation being inaccurate or incomplete in any way for any reason, whether by negligence or otherwise. Regeneus and its advisors make no recommendations as to whether investors or their related parties should participate in the Offers. Statements made in this Presentation are made only as at the date of this Presentation. The information in this Presentation remains subject to change without notice. Regeneus reserves the right to withdraw all or part of the Offers or vary the timetable for the Offers without notice.
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Financial Year 2023 in review
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Regeneus continues operating in a challenging year for the biopharma industry and our company.
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In FY 2023, the Company has engaged in several research and development projects – including manufacturing process and potency assay development for Progenza and completing a collaboration programme with the Australian Department of Defence.
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Our Japanese partner, Kyocera Corporation, made the decision to discontinue Progenza development for Japan and consequently terminated the Collaboration and License Agreement in January 2023.
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Regeneus promptly right-sized the organisation to preserve capital and shareholder value. We continue operating under a lean, capital-efficient model.
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Additionally, in February 2023, the Company restructured its balance sheet by settling an outstanding loan plus accrued interest owed to Paddington St Finance. The settlement comprised a $400,000 cash payment and the transfer of 700,000 shares, which Regeneus held in Sangui Bio Pty Ltd.
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Regeneus continued business development efforts to find suitable partners for Progenza co-development in the United States, South Korea, and China in FY2023.
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The Company is now primarily focused on completing a merger transaction with Cambium Medical Technologies, LLC in the United States of America.
Regeneus Board and CEO would like to thank all shareholders for their patience and ongoing support
as we enter an exciting new stage in Regeneus history.
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Merger transaction update
Status Update
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On 28 April 2023, Regeneus announced that it had signed a non-binding term sheet to merge with Cambium Medical Technologies, LLC (“CMT”, “Target”).
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The parties are currently negotiating a definitive Merger Agreement, which is currently in the 4[th] draft.
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Agreement has been reached on key commercial deal terms.
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Regeneus is working towards executing the binding agreement within the 2023 calendar year.
Select Key Deal Topics
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Capital gain tax obligations for CMT shareholders had to be addressed.
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Post-merger, key Regeneus and CMT shareholders will be subject to a 12-month lock-up restricting share sales.
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Both parties are restructuring CMT's balance sheet, including resolving accounts payable and warrant obligations.
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Management service contracts for the combined entity leadership team are under discussion.
Financing
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Regeneus has engaged with key CMT shareholders regarding potential financing of the merged company.
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The data room has been opened for further due diligence.
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Indicative merger transaction timeline
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Day •
0 Execution of the definitive Merger Agreement and ancillary documents by all parties
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Preparation and Regeneus Board approval of draft Notice of Meeting (“NOM”) & Proxy
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Day •
4 Send draft NOM & Proxy to ASX for review
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Day ASX notice of no objection
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Mailing NOM and Proxy to Regeneus shareholders
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Regeneus Extraordinary General Meeting (EGM). Merger transaction closes
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Contact details
[email protected] 1 300 995 098 www.regeneus.com
Regeneus Ltd
16 Goodhope Street Paddington, NSW 2021 Australia
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