

• | sufficiency of our capital resources; |
• | our ability to raise additional funding when needed; |
• | our current and future R&D activities, including clinical testing and manufacturing and related costs and timing; |
• | our product development and business strategy, including the potential size of the markets for our products and future development and/or expansion of our products in our markets; |
• | our ability to commercialize products and generate product revenues; |
• | any statements concerning anticipated regulatory activities, including our ability to obtain regulatory clearances; |
• | our R&D expenses; and |
• | risks facing our operations and intellectual property. |
• | instruct the Depositary Nominee, as legal owner of the shares of Common Stock, to vote the Common Stock represented by their CDIs to vote the shares of our Common Stock represented by their CDIs in a particular manner. A voting instruction form will be sent to holders of CDIs and must be completed and returned to the share registry for the CDIs prior to a record date fixed for the relevant meeting, or the CDI Voting Instruction Receipt Time, which is notified to CDI holders in the voting instructions included in a notice of meeting; |
• | inform us that they wish to appoint themselves or a third party as the Depositary Nominee’s proxy with respect to our shares of Common Stock underlying the holder’s CDIs for the purposes of attending and voting at the meeting. The instruction form must be completed and returned to the share registry for the CDI prior to the CDI Voting Instruction Receipt Time; or |
• | convert their CDIs into shares of our Common Stock and vote those shares at the meeting. The conversion must be undertaken prior to a record date fixed by the Board of Directors for determining the entitlement of stockholders to attend and vote at the meeting. If the holder later wishes to sell their investment on the ASX, it would first be necessary to convert those shares of Common Stock back to CDIs. Further details on the conversion process are set out below. |
• | directly in the case of CDIs held on the issuer sponsored sub-register operated by the Company (holders of CDIs are provided with a CDI issuance request form to return to the share registry for the CDIs); or |
• | through their “sponsoring participant” (usually their broker) in the case of CDIs which are held on the CHESS sub-register (in this case, the sponsoring broker will arrange for completion of the relevant form and its return to the share registry for the CDIs). |
• | the designation of the series; |
• | the number of shares of the series; |
• | the dividend rate or rates on the shares of that series, whether dividends will be cumulative and, if so, from which date or dates, and the relative rights of priority, if any, of payment of dividends on shares of that series; |
• | whether the series will have voting rights in addition to the voting rights provided by law and, if so, the terms of such voting rights; |
• | whether the series will have conversion privileges and, if so, the terms and conditions of such conversion, including provision for adjustment of the conversion rate in such events as the Board of Directors determines; |
• | whether or not the shares of that series will be redeemable, in whole or in part, at the option of the Company or the holder thereof and, if made subject to such redemption, the terms and conditions of such redemption, including the date or dates upon or after which they will be redeemable, and the amount per share payable in case of redemptions, which amount may vary under different conditions and at different redemption rates; |
• | the terms and amount of any sinking fund provided for the purchase or redemption of the shares of such series; |
• | the rights of the shares of that series in the event of voluntary or involuntary liquidation, dissolution or winding up of the Company, and the relative rights of priority, if any, of payment of shares of that series; |
• | the restrictions, if any, on the issue or reissue of any additional preferred stock; and |
• | any other relative rights, preferences and limitations of that series. |
• | the ability of our Board of Directors to issue shares of preferred stock and to determine the price and other terms of those shares, including preferences and voting rights, without stockholder approval, which could be used to significantly dilute the ownership of a hostile acquirer; |
• | a staggered Board of Directors divided into three classes serving staggered three-year terms, such that not all members of our Board of Directors will be elected at one time; |
• | allowing only our Board of Directors to fill director vacancies, which prevents stockholders from being able to fill vacancies on our Board of Directors; |
• | a prohibition on stockholder action by written consent, which forces stockholder action to be taken at an annual or special meeting of our stockholders; |
• | a requirement for the affirmative vote of holders of at least 75% of the voting power of all of the then-outstanding shares of the voting stock, voting together as a single class, to amend certain provisions of our Second Amended and Restated Certificate of Incorporation or our Amended and Restated Bylaws, which may inhibit the ability of an acquirer to effect such amendments to facilitate an unsolicited takeover attempt; |
• | the ability of our Board of Directors to amend our Amended and Restated Bylaws, which may allow our Board of Directors to take additional actions to prevent an unsolicited takeover and inhibit the ability of an acquirer to amend the Amended and Restated Bylaws to facilitate an unsolicited takeover attempt; |
• | advance notice procedures with which stockholders must comply to nominate candidates to our Board of Directors or to propose matters to be acted upon at a stockholders’ meeting, which may discourage or deter a potential acquirer from conducting a solicitation of proxies to elect the acquirer’s own slate of directors or otherwise attempting to obtain control of our company; and |
• | a prohibition of cumulative voting in the election of our Board of Directors, which would otherwise allow less than a majority of stockholders to elect director candidates. |
Name of Selling Stockholder | Number of Shares of Common Stock Beneficially Owned Prior to Offering | Maximum Number of Shares of Common Stock to be Sold Pursuant to this Prospectus | Number of Shares of Common Stock Beneficially Owned After Offering | Percent of Common Stock Beneficially Owned After Offering | ||||||||
ADAR1 Partners, LP | 710,205 | 1,420,410(1) | — | * | ||||||||
ADAR1 SPV I, LP | 204,081 | 408,162(2) | — | * | ||||||||
Blackwell Partners LLC - Series A | 1,228,283 | 465,326(3) | 995,620 | 2.4% | ||||||||
Blue Lake Partners Pty Ltd | 26,668 | 53,336(4) | — | * | ||||||||
Evolution Capital Advisors Pty Ltd | 432,080 | 747,960(5) | 58,100 | * | ||||||||
L1 Capital Pty Ltd | 8,219,814 | 2,666,668(6) | 6,886,480 | 16.7% | ||||||||
Lytton-Kambara Foundation | 612,244 | 1,224,488(7) | — | * | ||||||||
Mishtalem Pty Ltd | 253,980 | 497,960(8) | 5,000 | * | ||||||||
Nantahala Capital Partners Limited Partnership | 826,302 | 680,594(9) | 486,005 | 1.2% | ||||||||
NCP RFM LP | 271,322 | 78,568(10) | 232,038 | * | ||||||||
Rhenman & Partners Asset Management AB | 222,000 | 444,000(11) | — | * | ||||||||
Sio Partners Offshore, Ltd | 362,482 | 87,340(12) | 318,812 | * | ||||||||
Name of Selling Stockholder | Number of Shares of Common Stock Beneficially Owned Prior to Offering | Maximum Number of Shares of Common Stock to be Sold Pursuant to this Prospectus | Number of Shares of Common Stock Beneficially Owned After Offering | Percent of Common Stock Beneficially Owned After Offering | ||||||||
Sio Partners LP | 526,030 | 116,740(13) | 467,660 | 1.1% | ||||||||
Spearhead Insurance Solutions IDF, LLC - Series ADAR1 | 333,381 | 212,244(14) | 227,259 | * | ||||||||
* | less than 1% |
(1) | Consists of (i) 710,205 Shares and (ii) 710,205 Common Stock Warrant Shares. ADAR1 Capital Management, LLC (“ADAR1 Capital Management”) acts as an investment adviser to, and manages investment accounts of, the ADAR1 Partners, LP (“ADAR1 Partners”). ADAR1 Capital Management GP, LLC (“ADAR1 General Partner”) acts as the general partner of ADAR1 Partners. Daniel Schneeberger is the Manager of ADAR1 Capital Management and ADAR1 General Partner and may be deemed to beneficially own securities held by ADAR1 Partners. Mr. Schneeberger disclaims beneficial ownership of such securities, except to the extent of his pecuniary interest therein. The business address of ADAR1 Partners is 3503 Wild Cherry Drive, Building 9, Austin, Texas 78738. |
(2) | Consists of (i) 204,081 Shares and (ii) 204,081 Common Stock Warrant Shares. ADAR1 Capital Management acts as an investment adviser to, and manages investment accounts of, ADAR1 SPV I, LP (“ADAR1 SPV”). ADAR1 General Partner acts as the general partner of ADAR1 SPV. Daniel Schneeberger is the Manager of ADAR1 Capital Management and ADAR1 General Partner and may be deemed to beneficially own securities held by ADAR1 SPV. Mr. Schneeberger disclaims beneficial ownership of such securities, except to the extent of his pecuniary interest therein. The business address of ADAR1 SPV is 3503 Wild Cherry Drive, Building 9, Austin, Texas 78738. |
(3) | Consists of (i) 232,663 Shares and (ii) 232,663 Common Stock Warrant Shares. Each of Wilmot Harkey and Daniel Mack may be deemed to be beneficial owners of securities held by Blackwell Partners LLC – Series A (“Blackwell Partners”) as the managing members of Nantahala Capital Management, LLC, which is the investment manager of Blackwell Partners. The business address of Blackwell Partners is 280 South Magnum Street, Suite 210, Durham, North Carolina 27701. |
(4) | Consists of (i) 26,668 CDI Shares and (ii) 26,668 CDI Warrant Shares. James Chen and Daniel Droga are the general partners of Blue Lake Partners Pty Ltd (“Blue Lake”) and can each exercise sole voting and investment power with respect to the securities held by Blue Lake and, accordingly, may be deemed to beneficially own the securities held by Blue Lake. The business address of Blue Lake is L20, 1 Macquarie Place, Sydney NSW, Australia 2000. |
(5) | Consists of (i) 248,980 CDI Shares, (ii) 248,980 CDI Warrant Shares received in the CDI Offering and (iii) 250,000 CDI Warrant Shares underlying CDI Warrants issued to the Selling Stockholder as compensation for acting as lead manager for the CDI Offering. Evolution Capital Advisors Pty Ltd (“Evolution Capital Advisors”) is an affiliated entity of Evolution Capital Pty Ltd. Stephen Marc Silver is a Director of Evolution Capital Pty Ltd and owner of Evolution Capital Advisors and has sole voting and investment power with respect to the securities held by Evolution Capital Advisors. The business address of Evolution Capital Advisors is Level 8, 143 Macquarie Street, Sydney NSW 2000. |
(6) | Consists of (i) 1,333,334 CDI Shares and (ii) 1,333,334 CDI Warrant Shares. Mark Landau is a Director of L1 Capital Pty Ltd. As such, he may be deemed to beneficially own (as that term is defined in Rule 13d-3 under the Exchange Act) the issuer’s securities described herein. To the extent Mr. Landau is deemed to beneficially own such securities, he disclaims beneficial ownership of these securities for all other purposes. The business address of L1 Capital Pty Ltd is Level 45, 101 Collins Street, Melbourne VIC 3000, C3 00000, Australia. |
(7) | Consists of (i) 612,244 Shares and (ii) 612,244 Common Stock Warrant Shares. Laurence Lytton is the President of the Lytton-Kambara Foundation and has sole voting and investment power with respect to the securities held by the Lytton-Kambara Foundation. The business address of the Lytton-Kambara Foundation is 467 Central Park West 17-A, New York, New York 10025. |
(8) | Consists of (i) 248,980 CDI Shares and (ii) 248,980 CDI Warrant Shares. Menachem Mendel Amzalak is the owner of Mishtalem Pty Ltd (“Mishtalem”) and has sole voting and investment power with respect to the securities held by Mishtalem. The business address of Mishtalem is Level 8, 143 Macquarie Street, Sydney NSW 2000. |
(9) | Consists of (i) 340,297 Shares and (ii) 340,297 Common Stock Warrant Shares. Each of Wilmot Harkey and Daniel Mack may be deemed to be beneficial owners of securities held by Nantahala Capital Partners Limited Partnership (“NCPLP”) as the managing members of Nantahala Capital Management, LLC, which is the general partner of NCPLP. The business address of NCPLP is c/o Nantahala Capital Management, LLC, 130 Main Street, 2nd Floor, New Canaan, Connecticut 06840. |
(10) | Consists of (i) 39,284 Shares and (ii) 39,284 Common Stock Warrant Shares. Each of Wilmot Harkey and Daniel Mack may be deemed to be beneficial owners of securities held by NCP RFM LP (“NCP RFM”) as the managing members of Nantahala Capital Management, LLC, which is the investment manager of NCP RFM. The business address of NCP RFM is c/o Nantahala Capital Management, LLC, 130 Main Street, 2nd Floor, New Canaan, Connecticut 06840. |
(11) | Consists of (i) 222,000 CDI Shares and (ii) 222,000 CDI Warrant Shares. Henrik Rhenman is a Director of Rhenman & Partners Asset Management AB (“Rhenman & Partners”) and has sole voting and investment power with respect to the securities held by Rhenman and Partners. The business address of Rhenman & Partners is Strandvägen 5A, 114 51 Stockholm, Sweden. |
(12) | Consists of (i) 43,670 Shares and (ii) 43,670 Common Stock Warrant Shares. Sio Capital Management, LLC (“Sio Management”) is the investment manager of Sio Partners Offshore, Ltd (“Sio Partners Offshore”) and Michael Castor is the sole owner and Managing Member of Sio Management. Sio Management and Mr. Castor may be deemed to beneficially own the securities held by Sio Partners Offshore. Each of Sio Management and Mr. Castor disclaim beneficial ownership of any of the shares of our Common Stock they may be deemed to beneficially own except to the extent of their respective pecuniary interest therein. The business address of Sio Partners Offshore is 600 Third Ave., 2nd Floor, New York, New York 10016. |
(13) | Consists of (i) 58,370 Shares and (ii) 58,370 Common Stock Warrant Shares. Sio Management is the investment manager of Sio Partners LP (“Sio Partners”) and Michael Castor is the sole owner and Managing Member of Sio Management. Sio Management and Mr. Castor may be deemed to beneficially own the securities held by Sio Partners. Each of Sio Management and Mr. Castor disclaim beneficial |
(14) | Consists of (i) 106,122 Shares and (ii) 106,122 Common Stock Warrant Shares. ADAR1 Capital Management acts as sub-adviser to, and manages investment accounts of, Spearhead Insurance Solutions IDF, LLC – Series ADAR1 (“Spearhead”). Daniel Schneeberger is the Manager of ADAR1 Capital Management and may be deemed to beneficially own securities held by Spearhead. Mr. Schneeberger disclaims beneficial ownership of such securities, except to the extent of his pecuniary interest therein. The business address of Spearhead is 3828 Kennette Pike, Suite 202, Greenville, Delaware 19807. |
• | ordinary brokerage transactions and transactions in which the broker-dealer solicits purchasers; |
• | block trades in which the broker-dealer will attempt to sell the shares as agent but may position and resell a portion of the block as principal to facilitate the transaction; |
• | purchases by a broker-dealer as principal and resale by the broker-dealer for its account; |
• | an exchange distribution in accordance with the rules of the applicable exchange; |
• | privately negotiated transactions; |
• | in underwritten transactions; |
• | settlement of short sales; |
• | in transactions through broker-dealers that agree with the Selling Stockholders to sell a specified number of such shares at a stipulated price per share; |
• | through the writing or settlement of options or other hedging transactions, whether through an options exchange or otherwise; |
• | distribution to members, limited partners or stockholders of Selling Stockholders; |
• | “at the market” or through market makers or into an existing market for the shares; |
• | a combination of any such methods of sale; or |
• | any other method permitted pursuant to applicable law. |
• | our Annual Report on Form 10-K for the year ended December 31, 2024, filed with the SEC on March 12, 2025 (as amended by Amendment No. 1 on Form 10-K/A, filed with the SEC on April 29, 2025); |
• | our Quarterly Reports on Form 10-Q for the quarter ended March 31, 2025, filed with the SEC on May 13, 2025, for the quarter ended June 30, 2025, filed with the SEC on August 11, 2025, and for the quarter ended September 30, 2025, filed with the SEC on November 12, 2025; |
• | our Current Reports on Form 8-K filed with the SEC on March 6, 2025, June 9, 2025, July 29, 2025, August 7, 2025, September 4, 2025, September 11, 2025, September 19, 2025, September 29, 2025, October 15, 2025 (solely with respect to Items 5.08 and 8.01), October 24, 2025 (solely with respect to Item 3.02), October 27, 2025, December 1, 2025 and December 4, 2025; and |
• | the description of our Common Stock contained in Exhibit 4.3 to our Annual Report on Form 10-K filed with the SEC on March 12, 2025, and all subsequently filed amendments and reports updating that description. |