Neuphoria Therapeutics Inc.
For the period ended Sep 30, 2025. Filed Nov 14, 2025.
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A company's report for each of its first three quarters. The financial statements are not audited. It shows how the business has moved since the last annual report, and what management says changed.
Sep 30, 2025 · Filed Nov 14, 2025
NEUP$2.78+0.4%Stored close · as of Nov 6, 2026
What changed in Management’s Discussion and Analysis?
Read the current filingPrevious report: 10-Q
Period ended 2025-03-31; filed 2025-05-20.
0000950170-25-075175
Item 2. Management’s Discussion and Analysis of Financial Condition and Results of OperationsCurrent report: 10-Q
Period ended 2025-09-30; filed 2025-11-14.
0001193125-25-281579
Item 2. Management’s Discussion and Analysis of Financial Condition and Results of OperationsThe baseline is this issuer’s latest earlier reporting period of the same form that was filed before the current report. A previous 10-Q is a different quarter, not a year-over-year comparison. Amendments are excluded.
Compared 114 previous paragraphs and 94 current paragraphs.
54 unchanged; 24 reworded; 13 added; 34 removed; 2 previous and 3 current paragraphs rearranged.
Tables are not compared: 3 previous and 2 current tables excluded. Dates, whitespace, punctuation and numbering changes are ignored; changes to financial figures remain significant.
A changed paragraph is not evidence that risk increased or decreased. An unchanged paragraph does not establish that risk stayed the same.
Added paragraphs (13)
Current report
Phase 3 SAD Clinical Trial Results
Current report
On October 20, 2025 the Company announced that the AFFIRM-1 Phase 3 trial of BNC210 for the acute treatment of social anxiety disorder ("SAD") did not meet its primary endpoint of change from baseline to the average of the performance phase of the public speaking challenge in Subjective Units of Distress Scale scores. In addition, analyses of secondary endpoints did not demonstrate statistically significant differences. The safety and tolerability profile of BNC210 continued to be favorable and was consistent with previously reported studies.
Current report
Based on the results from the AFFIRM-1 trial, the Company further announced that it will discontinue further development of its SAD program. Given previous positive data with chronic daily dosing, Neuphoria also plans to evaluate next steps for further development of BNC210 in post-traumatic stress disorder.
Current report
Shareholder Rights Plan
Current report
On October 27, 2025 the Board of Directors (the “Board”) of Neuphoria Therapeutics Inc. declared a dividend of one right (“Right”) to purchase one-thousandth of one share of the Company’s newly designated Series A Preferred Stock, par value $0.00001 per share (each, a “Preferred Share” and collectively, the “Preferred Shares”), for each outstanding share of common stock, par value $0.00001 per share, of the Company to the stockholders of record as of the close of business on October 27, 2025 (the “Record Date”). The Company also adopted a limited duration stockholder rights plan (the “Rights Plan”), effective immediately, as set forth in the Rights Agreement, dated as of October 27, 2025 (the “Rights Agreement”), by and between the Company and Computershare Trust Company, N.A., as Rights Agent. The Rights Agent currently serves as the Company’s transfer agent with respect to the Company Common Stock and also has been appointed transfer agent with respect to the Preferred Shares, if any, that may be issued pursuant to the exercise of rights under the Rights Agreement. The Rights will expire on October 27, 2026, unless the rights are earlier redeemed or exchanged by the Company. The Company does not have any obligation under the Rights Agreement to seek stockholder approval for the Rights Plan. In connection with the Rights Plan, the Company also filed a Certificate of Designation with the Secretary of State of the State of Delaware on October 27, 2025 with respect to the Series A Preferred Stock shares issuable under the Rights Plan. Per the terms of the Rights Plan, the purchase price for each 1/1000th of a Preferred Share pursuant to the exercise of a Right shall initially be $85.00. There were no exercises under the Shareholders Rights Plan as of November 14, 2025.
Current report
Generally, the Rights Plan is designed to impose a penalty upon any person or group that acquires beneficial ownership of 15% or more of the outstanding shares of Company Common Stock without the approval of the Board. The Board adopted the Rights Plan in response to significant and rapid accumulations of the Company’s Common Stock by certain investors who have indicated a potential desire to influence the control of Neuphoria. The Rights Plan is intended to protect the investment of Neuphoria stockholders during a period in which it believes shares of the Company do not reflect the Company’s intrinsic value. The Rights Plan is intended to provide the Board sufficient time to make informed judgments and take actions that are in the best interests of the Company and all of its stockholders. The Rights Plan does not prevent the Board from engaging with parties or accepting an acquisition proposal if the Board believes that it is in the best interests of the Company and all of its stockholders.
Current report
Strategic Review
Current report
On November 11, 2025, and as previously indicated by the Company via prior press releases, the Company’s Board of Directors announced the initiation of a review of strategic alternatives to advance its promising pipeline programs and maximize stockholder value. Strategic alternatives under consideration may include, but are not limited to, mergers, acquisitions, partnerships, joint ventures, licensing arrangements or other strategic transactions.
Current report
Neuphoria does not have a defined timeline for the exploration of strategic alternatives and is not confirming that the process will result in any strategic alternative being announced or consummated. In addition, on November 10, 2025, the Company received an unsolicited non-binding indication of interest from Lynx1 Master Fund LP expressing its interest in acquiring all of the outstanding shares of Neuphoria that it does not already own for $5.20 per share in cash and of its intent to nominate certain individuals to stand for election to Neuphoria’s Board of Directors at the Company’s 2025 Annual Meeting of Stockholders. At the 2025 Annual Meeting, there are two Class I Directors standing for election. Neuphoria’s Board of Directors, consistent with its fiduciary duties and responsibilities, plans to carefully evaluate and consider this indication of interest in connection with its broad review of strategic alternatives, and its ongoing review of a broad range of opportunities to enhance stockholder value through strategic, financial, and operational measures.
Current report
Research and Development Expenses
Current report
Other Income (Loss)
Current report
Research and Development Expenses
Current report
Other Income (Loss)
Removed paragraphs (34)
Previous report
In addition, the Company has a strategic partnership with Merck & Co., Inc. (known as MSD outside the United States and Canada) with two drugs in early-stage clinical trials for the treatment of cognitive deficits in Alzheimer’s disease and other central nervous system conditions. Our pipeline also includes the α7 nicotinic acetylcholine receptor next generation and the Kv3.1/3.2 preclinical programs, both in the lead optimization development stage.
Previous report
We were incorporated in 1996 in Australia, completed our initial public offering and listing of ordinary shares on the ASX in 1999, and completed our initial public offering and listing of our ADSs on the Nasdaq Global Market in 2021. On July 25, 2023, we requested to be delisted from the official list of the ASX, which became effective August 28, 2023 and, as a result, our ordinary shares are no longer quoted or traded on the ASX. We were formally known as Bionomics Limited, an Australian company. On October 1, 2024 we entered into a Scheme Implementation Agreement with Neuphoria to re-domicile to the State of Delaware pursuant to a Scheme of Arrangement under Australian law. On December 23, 2024, the re-domiciliation of Bionomics was implemented and effectuated in accordance with the Scheme Implementation Agreement, as amended, and more fully described under “Recent Developments” below.
Previous report
Although the Company has been successful in raising capital in the past, there is no assurance that it will be successful in obtaining such additional financing on terms acceptable to the Company, if at all, nor is it considered probable under the accounting standards. If the Company is unable to obtain sufficient funding on acceptable terms, it could be forced to delay, reduce or eliminate some or all its research and development programs or commercialization activities, which could materially adversely affect its business prospects or its ability to continue operations.
Previous report
On October 1, 2024, Bionomics Limited, an Australian corporation ("Bionomics") announced its intention to redomicile from Australia to the United States (the “Redomiciliation”) via a proposed scheme of arrangement under Australian law between Bionomics and its shareholders (the “Scheme”). Implementation of the Scheme was subject to approval of Bionomics’ shareholders as well as Australian regulatory and court approvals.
Previous report
On December 23, 2024 U.S. time (“Effective Date”), the Redomiciliation of Bionomics was implemented under Australian law in accordance with a Scheme Implementation Agreement (as amended) between Bionomics and Neuphoria Therapeutics Inc., a Delaware corporation. The Redomiciliation was effected pursuant to a statutory Scheme of Arrangement under Australian law (the “Scheme”). As a result of the Redomiciliation, Bionomics became a wholly-owned subsidiary of Neuphoria, which is the new ultimate parent company. The terms “we,” “our,” “us” in this description refer to Bionomics prior to the Effective Date and Neuphoria after the Effective Date.
Previous report
In connection with the Scheme:
Previous report
holders of ordinary shares of Bionomics received one share of common stock in Neuphoria for every 2,160 ordinary shares of Bionomics held on the Scheme record date; and
Previous report
holders of American Depositary Shares (“ADSs”), with each ADS representing 180 ordinary shares of Bionomics, received one share of common stock of Neuphoria for every 12 ADSs held on the Scheme record date.
Previous report
The shares of common stock issued by Neuphoria upon implementation of the Scheme were exempt from registration under the Securities Act of 1933, as amended (the “Securities Act”), pursuant to Section 3(a)(10) thereof.
Previous report
In addition, pursuant to Stock Option Notice and Agreements, Neuphoria has issued options to acquire shares of common stock in Neuphoria (“Neuphoria Options”) to holders of options to acquire shares in Bionomics in exchange for their outstanding stock options granted by Bionomics Limited at a ratio of one share of Neuphoria’s common stock for every 2,160 ordinary shares of Bionomics. The issuance of Neuphoria Options will be issued under a registration statement on Form S-8 (File No. 333-284544), which has been filed with and declared effective by the SEC on January 28, 2025.
Previous report
Neuphoria has also issued a warrant to purchase 1,054,381 shares of common stock in Neuphoria (“Neuphoria Warrant”) pursuant to the terms of an exchange agreement to an institutional investor that previously held a warrant to purchase 12,652,572 American Depositary Shares (“ADSs”) of Bionomics (“Bionomics Warrant”), in exchange for the Bionomics Warrant. The issuance of the Neuphoria Warrant is exempt from registration under the Securities Act, pursuant to Section 4(a)(2) thereof.
Previous report
Prior to the Redomiciliation, Bionomics’ ordinary shares were registered pursuant to Section 12(b) of the Securities Exchange Act of 1934, as amended (the “Exchange Act”), and ADSs representing its ordinary shares were listed on the Nasdaq Global Market (“Nasdaq”). Bionomics’ ADSs were suspended from trading on Nasdaq prior to the start of trading on the Effective Date and, following the Effective Date, will no longer trade on Nasdaq.
Previous report
Pursuant to Rule 12g-3(a) under the Exchange Act, as of the Effective Date:
Previous report
Neuphoria is the successor issuer to Bionomics;
Previous report
Neuphoria’s shares of common stock are deemed to be registered under Section 12(b) of the Exchange Act; and
Previous report
Neuphoria is subject to the periodic and current reporting requirements of the Exchange Act and the rules and regulations promulgated thereunder. Neuphoria hereby reports this succession in accordance with Rule 12g-3(f) under the Exchange Act.
Previous report
Neuphoria’s shares of common stock commenced trading on Nasdaq at the start of trading on December 24, 2024 under the symbol “NEUP”. The CUSIP for Neuphoria’s shares of common stock is 64136E102.
Previous report
Bionomics has also filed Form 15 with the Securities and Exchange Commission (“SEC”) to terminate the registration (and the registration statements related thereto) under the Exchange Act of Bionomics’ ordinary shares and to suspend its reporting obligations under Sections 13 and 15(d) of the Exchange Act, and each such registration termination has been declared effective by the SEC.
Previous report
Revenue
Previous report
Our revenue increased during the three months ended March 31, 2025, as compared to the same period ended 2024, as a result of the $15 million milestone payment received from the Merck Agreement in March 2025.
Previous report
The $0.2 million increase in general and administrative expenses during the three months ended March 31, 2025, as compared to the same period ended in 2024, was due to an increase in consulting costs of $0.1 million in the current period combined with increases in administrative costs of $0.2 million, as the Company focused on integration activities associated with the redomiciliation that occurred on December 24, 2024, partially offset by a decrease in professional services of $0.1 million.
Previous report
Comparison of the nine months ended March 31, 2025 and 2024
Previous report
Revenue
Previous report
Our revenue increased during the nine months ended March 31, 2025, as compared to the same period ended 2024, as a result of the $0.7 million milestone payment received from the licensing agreement with Carina Biotech Pty Ltd in October 2024 and the $15 million milestone payment received from the Merck Agreement in March 2025.
Previous report
Our research and development activities in the nine months ended March 31, 2025 and 2024 were principally focused on the advancement of BNC210. The decrease in the nine months ended March 31, 2025 of approximately $1.1 million, as compared to the same period ended in 2024, was primarily due to decreased expenditures of $0.6 million for the SAD PREVAIL Phase 3 clinical trial, which started during February 2022, decreased expenditures of $0.2 million for salaries and consulting expenses, decreased expenditures of $0.1 million associated with patent prosecution, and decreased expenditures of $0.2 million for other general research & development activities.
Previous report
General and Administrative Expenses
Previous report
Comparison of the nine months ended March 31, 2025 and 2024
Previous report
The $8.5 million of net income for the nine months ended March 31, 2025, as compared to the net loss of $12.8 million for the nine months ended March 31, 2024, was partially offset by a $0.6 million decrease in share based compensation during the nine months ended March 31, 2025, combined with the $0.5 million effect of the remeasurement of contingent consideration and the $2.8 million effect of the remeasurement of the accompanying warrant liability, a $0.7 million effect of foreign currency remeasurement, and a $1.4 million increase in cash used for working capital, all as compared to the nine months ended March 31, 2024.
Previous report
On November 18, 2024, the Company announced the establishment of an ATM offering agreement (the “Sales Agreement”) with H.C. Wainwright & Co., LLC (the “Sales Agent”). Pursuant to the Sales Agreement, the Sales Agent will act as the Company’s agent with respect to an offering and sale, at any time and from time to time, of the Company’s common stock, par value per share of $.00001(the “Shares”). The Company has authorized the sale, at its discretion, of Shares in an aggregate offering amount up to $3,560,318 under the Sales Agreement. Sales of the Shares, if any, under the Sales Agreement will be made in “at the market offerings” as defined in Rule 415 under the Securities Act of 1933, as amended (the “Securities Act”). The Sales Agent will use commercially reasonable efforts consistent with normal trading and sales practices.
Previous report
The offer and sale of the Shares will be made pursuant to the Company’s shelf registration statement on Form S-3, which was filed with the Securities and Exchange Commission (“SEC”) and declared effective on January 8, 2025 (File No. 333-283306, the “Registration Statement”), and a related prospectus, as supplemented by a prospectus supplement pursuant to Rule 424(b). The Company is not obligated to make any sales of Shares under the Sales Agreement and no assurance can be given that we will sell any Shares under the Sales Agreement, or if we do, as to the price or amount of Shares that we will sell, or the dates on which any such sales will take place (other than as reportable on our periodic reports filed with the SEC).
Previous report
The Company or the Sales Agent, under certain circumstances and upon notice to the other, may suspend the offering of the Shares under the Sales Agreement. The offering of the Shares pursuant to the Sales Agreement will terminate upon the sale of Shares in an aggregate offering amount equal to $3,560,318 (unless the saleable amount is increased), or sooner if either the Company or the Sales Agents terminate the Sales Agreement. The Company will pay the Sales Agent a cash commission in an amount up to 3.0% of the gross proceeds from each sale of Shares sold pursuant to the Sales Agreement.
Previous report
The Company has made sales under the Sales Agreement for net proceeds of approximately $1.1 million under its ATM facility during the nine months ended March 31, 2025. A copy of the Sales Agreement is filed as Exhibit 10.1 to our current report on Form 8-K filed with the SEC on November 21, 2024, which is incorporated herein by reference.
Previous report
Based upon our current operating plan, we believe that our existing cash and cash equivalents, combined with our existing ATM facility, will be sufficient to continue funding our development activities through late in the first quarter of fiscal 2027. We have based this estimate on assumptions that may prove to be wrong, and we could exhaust our available capital resources sooner than we expect. To finance our operations beyond that point we will need to raise additional capital, which cannot be assured. We have based this estimate on assumptions that may prove to be wrong, and we could utilize our available capital resources sooner than we currently expect. We will continue to require additional financing to advance our current product candidates through clinical development, to develop, acquire or in-license other potential product candidates and to fund operations for the foreseeable future. We will continue to seek funds through equity offerings, debt financings or other capital sources, including potential collaborations, licenses and other similar arrangements. However, we may be unable to raise additional funds or enter into such other arrangements when needed on favorable terms or at all. If we do raise additional capital through public or private equity offerings, the ownership interest of our existing shareholders, will be diluted, and the terms of these securities may include liquidation or other preferences that adversely affect our shareholders’ rights. If we raise additional capital through debt financing, we may be subject to covenants limiting or restricting our ability to take specific actions, such as incurring additional debt, making capital expenditures or declaring dividends. Any failure to raise capital as and when needed could have a negative impact on our financial condition and on our ability to pursue our business plans and strategies. If we are unable to raise capital, we will need to delay, reduce or terminate planned activities to reduce costs.
Previous report
Further, our operating plans may change, and we may need additional funds to meet operational needs and capital requirements for clinical trials and other research and development activities. Because of the numerous risks and uncertainties associated with the development and commercialization of our product candidates, we are unable to estimate the amounts of increased capital outlays and operating expenditures associated with our current and anticipated product development programs.
Reworded paragraphs (24)
Previous wording
We are a clinical-stage biopharmaceutical company developing novel, allosteric ion channel modulators designed to transform the lives of patients suffering from serious central nervous system (“CNS”) disorders with high unmet medical need. Ion channels serve as important mediators of physiological function in the CNS and the modulation of ion channels influences neurotransmission that leads to downstream signaling in the brain. The α7 nicotinic acetylcholine (“ACh”) receptor (“α7 receptor”) is an ion channel that plays an important role in driving emotional responses and cognitive performance. Utilizing our expertise in ion channel biology and translational medicine, we are developing orally active small molecule negative allosteric modulators (“NAMs”) to treat anxiety and stressor-related disorders. In addition, through a long-standing strategic partnership with Merck & Co., Inc., in the United States and Canada (“MSD”), we are also developing positive allosteric modulators (“PAMs”) of the α7 receptor to treat cognitive dysfunction. Neuphoria's pipeline also includes preclinical assets that target Kv3.1/3.2 and Nav1.7/1.8 ion channels being developed for CNS conditions of high unmet need.
Current wording
We are a clinical-stage biopharmaceutical company developing novel, allosteric ion channel modulators designed to transform the lives of patients suffering from serious central nervous system (“CNS”) disorders with high unmet medical need. Ion channels serve as important mediators of physiological function in the CNS and the modulation of ion channels influences neurotransmission that leads to downstream signaling in the brain. The α7 nicotinic acetylcholine (“ACh”) receptor (“α7 receptor”) is an ion channel that plays an important role in driving emotional responses and cognitive performance. Utilizing our expertise in ion channel biology and translational medicine, we have been developing orally active small molecule negative allosteric modulators (“NAMs”) to treat anxiety and stressor-related disorders. In addition, through a long-standing strategic partnership with Merck & Co., Inc., in the United States and Canada (“MSD”), we are also developing positive allosteric modulators (“PAMs”) of the α7 receptor to treat cognitive dysfunction. Neuphoria's pipeline also includes preclinical assets that target Kv3.1/3.2 and Nav1.7/1.8 ion channels being developed for CNS conditions of high unmet need.
Previous wording
We are a clinical-stage biotechnology company dedicated to developing therapies that address the complex needs of individuals affected by neuropsychiatric disorders. We are advancing our lead product candidate, BNC210, an oral, proprietary, selective NAM of the α7 receptor, for the chronic treatment of Post-Traumatic Stress Disorder (“PTSD”) and the acute treatment of Social Anxiety Disorder (“SAD”). There remains a significant unmet medical need for the over 27 million patients in the United States alone suffering from SAD and PTSD. BNC210 is a first-of-its-kind, well tolerated, broad spectrum anti-anxiety experimental therapeutic, designed to restore neurotransmitter balance in relevant brain areas, providing rapid relief from stress and anxiety symptoms without the common pitfalls of sedation, cognitive impairment, or addiction. Current pharmacological treatments include certain antidepressants and benzodiazepines, and there have been no new FDA approved therapies in these indications in nearly two decades. These existing treatments have multiple shortcomings, such as a slow onset of action of antidepressants, and significant side effects of both classes of drugs, including abuse liability, addiction potential and withdrawal symptoms. BNC210 has been observed in our clinical trials to have a fast onset of action and clinical activity without the limiting side effects seen with the current standard of care.
Current wording
As part of an expected strategic review of our operations and portfolio, we are assessing plans for our lead product candidate, BNC210, an oral, proprietary, selective NAM of the α7 receptor, for the chronic treatment of Post-Traumatic Stress Disorder (“PTSD”). There remains a significant unmet medical need for the over 9 million patients in the United States alone suffering from PTSD. BNC210 is a first-of-its-kind, well tolerated, broad spectrum anti-anxiety experimental therapeutic, designed to restore neurotransmitter balance in relevant brain areas, providing rapid relief from stress and anxiety symptoms without the common pitfalls of sedation, cognitive impairment, or addiction. Current pharmacological treatments include certain antidepressants and benzodiazepines, and there have been no new FDA approved therapies in these indications in nearly two decades. These existing treatments have multiple shortcomings, such as a slow onset of action of antidepressants, and significant side effects of both classes of drugs, including abuse liability, addiction potential and withdrawal symptoms. BNC210 has been observed in our clinical trials to have a fast onset of action and clinical activity without the limiting side effects seen with the current standard of care.
Previous wording
Our ability to generate revenue from product sales sufficient to achieve profitability will depend heavily on the successful development and eventual commercialization of one or more of our product candidates. As of March 31, 2025, our operations have been financed primarily by aggregate net proceeds of $192.7 million from the sale and issuances of our equity, $28.5 million in the form of an upfront payment, research funding and a milestone payment from the 2014 Merck Agreement, and $66.8 million from Australian research and development credits and government grants and assistance.
Current wording
Our ability to generate revenue from product sales sufficient to achieve profitability will depend heavily on the successful development and eventual commercialization of one or more of our product candidates. As of September 30, 2025, our operations have been financed primarily by aggregate net proceeds of $193.2 million from the sale and issuances of our equity, $13.5 million in the form of an upfront payment, research funding and a milestone payment from the 2014 Merck Agreement, and $67.1 million from Australian research and development credits and government grants and assistance.
Previous wording
Cash used to fund operating expenses is impacted by the timing of when we pay these expenses, as reflected in the change in our trade and other payables. We expect to continue to incur net losses for the foreseeable future, and we expect our research and development expenses, and our administrative and other expenses will continue to increase. In particular, we expect our expenses to increase as we continue our development of, and seek regulatory approvals for, our product candidates, as well as hire additional personnel, pay fees to outside consultants, lawyers and accountants, and incur other increased costs associated with being a U.S. public company, hiring U.S. personnel and establishing a U.S. infrastructure. In addition, if we seek and obtain regulatory approval to commercialize any product candidate, we will also incur increased expenses in connection with commercialization and marketing of any such product. Our net losses may fluctuate significantly from quarter-to-quarter and year-to-year, depending on the timing of our clinical trials and our expenditure on other research and development activities.
Current wording
Cash used to fund operating expenses is impacted by the timing of when we pay these expenses, as reflected in the change in our trade and other payables. We expect to continue to incur net losses for the foreseeable future.
Previous wording
Since inception, we have had significant operating losses and have an accumulated deficit of $169.5 million at March 31, 2025. The Company realized net income of $11.3 million and $8.5 million for the three and nine months ended March 31, 2025 and incurred a net loss of $15.5 million for the year ended June 30, 2024. The Company also generated $3.7 million of cash from operating activities during the nine months ended March 31, 2025.
Current wording
Since inception, we have had significant operating losses and have an accumulated deficit of $188.3 million at September 30, 2025. The Company incurred a net loss of $9.9 million and $0.8 million for the three months ended September 30, 2025 and 2024, respectively. The Company also had $3.8 million of cash used in operating activities during the three months ended September 30, 2025.
Previous wording
The Company has based projections of operating capital requirements on the current operating plan, which includes several assumptions that may prove to be incorrect, and the Company may use all available capital resources sooner than the Company expects. The accompanying condensed consolidated financial statements do not include adjustments that might result from the outcome of uncertainties and assumes the Company will continue as a going concern through the realization of assets and satisfaction of liabilities and commitments in the ordinary course of business.
Current wording
The Company has based projections of operating capital requirements on the current operating plan, which management believes can be effectively implemented. The operating plan incorporates several assumptions that may prove to be incorrect, and the Company may use all available capital resources sooner than the Company expects. The accompanying condensed consolidated financial statements do not include adjustments that might result from the outcome of uncertainties and assumes the Company will continue as a going concern through the realization of assets and satisfaction of liabilities and commitments in the ordinary course of business.
Previous wording
On March 14, 2025, the Company and Merck executed the Fifth Amendment to the Research Collaboration and License Agreement which amended the patent royalty rate set out in the Merck Agreement, such that, conditioned upon achievement of net sales thresholds set forth in the Merck Agreement, as amended, the Company will be paid royalties on net sales ranging from a low single digits percentage to a low sub-teens percentage, depending on net sales volume. There were no other changes in the transaction price during the nine months ended March 31, 2025.
Current wording
On March 14, 2025, the Company and Merck executed the Fifth Amendment to the Research Collaboration and License Agreement which amended the patent royalty rate set out in the Merck Agreement, such that, conditioned upon achievement of net sales thresholds set forth in the Merck Agreement, as amended, the Company will be paid royalties on net sales ranging from a low single digits percentage to a low sub-teens percentage, depending on net sales volume.
Previous wording
In November 2020, we entered into an IP license agreement (the “Carina Biotech License”) with Carina Biotech ("Carina"). Pursuant to the Carina Biotech License, we are eligible to receive approximately $3 million in certain development, regulatory milestone payments if Carina Biotech advances the development of the therapy to a Phase 3 trial. Carina Biotech is also obligated to pay us royalties on its net sales of licensed products, on a country-by-country and product-by-product basis, ranging from the low single digits to the mid-single digits, subject to certain specified deductions. Royalties are payable until the later of expiration of all licensed patents covering the licensed products, or expiration of all data exclusivity with respect to the licensed product. If Carina Biotech enters into one or more sublicensing agreements relating to the licensed product, we are eligible to receive a percentage of sublicensing revenues. On October 30, 2024, Carina made a milestone payment to the Company in the gross amount of A$1,000,000 which was recorded as revenue in the Condensed Consolidated Statement of Operations and Other Comprehensive Income (Loss) included in this Form 10-Q.
Current wording
In November 2020, we entered into an IP license agreement (the “Carina Biotech License”) with Carina Biotech ("Carina"). Pursuant to the Carina Biotech License, we are eligible to receive approximately $3 million in certain development, regulatory milestone payments if Carina Biotech advances the development of the therapy to a Phase 3 trial. Carina Biotech is also obligated to pay us royalties on its net sales of licensed products, on a country-by-country and product-by-product basis, ranging from the low single digits to the mid-single digits, subject to certain specified deductions. Royalties are payable until the later of expiration of all licensed patents covering the licensed products, or expiration of all data exclusivity with respect to the licensed product. If Carina Biotech enters into one or more sublicensing agreements relating to the licensed product, we are eligible to receive a percentage of sublicensing revenues. On October 30, 2024, Carina made a milestone payment to the Company in the gross amount of A$1,000,000 which was recorded as revenue during the three and six months ended December 31, 2024.
Previous wording
successful completion of our planned Phase 3 clinical trials in SAD and PTSD;
Current wording
successful completion of our planned Phase 3 clinical trial in PTSD;
Previous wording
Research and development activities account for a significant portion of our operating expenses. We expect our research and development expenses to increase substantially for the foreseeable future as we continue to implement our business strategy, which includes advancing BNC210 through clinical development and other product candidates into clinical development, expanding our research and development efforts, including hiring additional personnel to support our research and development efforts, and seeking regulatory approvals for our product candidates that successfully complete clinical trials. In addition, product candidates in later stages of clinical development generally incur higher development costs than those in earlier stages of clinical development, primarily due to the increased size and duration of later-stage clinical trials. As a result, we expect our research and development expenses to increase as our product candidates advance into later stages of clinical development. However, we do not believe that it is possible at this time to accurately project total program-specific expenses through commercialization. There are numerous factors associated with the successful commercialization of any of our product candidates, including future trial design and various regulatory requirements, many of which cannot be determined with accuracy at this time based on our stage of development. The process of conducting the necessary clinical development to obtain regulatory approval is costly and time-consuming, and the successful development of our product candidates is highly uncertain.
Current wording
Research and development activities account for a significant portion of our operating expenses. We expect our research and development expenses to increase substantially for the foreseeable future under the presumption that we continue to implement our business strategy, which includes advancing BNC210 through clinical development and other product candidates into clinical development, expanding our research and development efforts, including hiring additional personnel to support our research and development efforts, and seeking regulatory approvals for our product candidates that successfully complete clinical trials. In addition, product candidates in later stages of clinical development generally incur higher development costs than those in earlier stages of clinical development, primarily due to the increased size and duration of later-stage clinical trials. As a result, we expect our research and development expenses to increase as our product candidates advance into later stages of clinical development. However, we do not believe that it is possible at this time to accurately project total program-specific expenses through commercialization. There are numerous factors associated with the successful commercialization of any of our product candidates, including future trial design and various regulatory requirements, many of which cannot be determined with accuracy at this time based on our stage of development. The process of conducting the necessary clinical development to obtain regulatory approval is costly and time-consuming, and the successful development of our product candidates is highly uncertain.
Previous wording
Our financial results are reported in U.S. dollars. A substantial portion of our operating expenses and other income are denominated in the Australian dollar. During the nine months ended March 31, 2025 and 2024, we managed our exchange rate exposure principally by maintaining foreign currency cash accounts and managing our payments from the most appropriate accounts. From time to time, we may additionally use forward exchange contracts in an effort to manage certain foreign exchange rate exposures when appropriate. There were no foreign exchange contracts used during the nine months ended March 31, 2025 and 2024, respectively. See “Quantitative and Qualitative Disclosures about Market Risk” for more information.
Current wording
Our financial results are reported in U.S. dollars. A substantial portion of our operating expenses and other income are denominated in the Australian dollar. During the three months ended September 30, 2025 and 2024, we managed our exchange rate exposure principally by maintaining foreign currency cash accounts and managing our payments from the most appropriate accounts. From time to time, we may additionally use forward exchange contracts in an effort to manage certain foreign exchange rate exposures when appropriate. There were no foreign exchange contracts used during the three months ended September 30, 2025 and 2024, respectively. See “Quantitative and Qualitative Disclosures about Market Risk” for more information.
Previous wording
Our research and development activities in the three months ended March 31, 2025 and 2024 were principally focused on the advancement of BNC210. The increase in the three months ended March 31, 2025 of approximately $0.4 million, as compared to the same period ended 2024, was primarily due to increased expenditures associated with the PTSD ATTUNE clinical trial $0.1 million combined with an increase in expenditures for our SAD PREVAIL Phase 3 clinical trial of $0.5 million, partially offset by decreases in salaries expense and consulting expense of $0.2 million.
Current wording
Our research and development activities in the three months ended September 30, 2025 and 2024 were principally focused on the advancement of BNC210. The increase in the three months ended September 30, 2025 of approximately $1.9 million, as compared to the same period ended 2024, was primarily due to increased expenditures associated with the PTSD ATTUNE clinical trial of $1.0 million combined with an increase in expenditures for our SAD PREVAIL Phase 3 clinical trial of $1.0 million and increased headcount costs of $0.1 million, partially offset by a decrease in professional fees of $0.2 million..
Previous wording
During the three months ended March 31, 2025, approximately 80% of the total research and development expenses related to the advancement of our BNC210-based programs. Of the total BNC210-based program spend during the three months ended March 31, 2025, approximately 15% was attributable to PSTD ATTUNE and 65% to SAD Prevail. We do not track labor associated with each program and have allocated headcount costs on a pro-rated basis. Management believes the pro rata allocation results in a reasonable estimate of the headcount costs associated with each of the programs noted above.
Current wording
During the three months ended September 30, 2025, approximately 90% of the total research and development expenses related to the advancement of our BNC210-based programs. Of the total BNC210-based program spend during the three months ended September 30, 2025, approximately 40% was attributable to PSTD ATTUNE and 50% to SAD Prevail. We do not track labor associated with each program and have allocated headcount costs on a pro-rated basis. Management believes the pro rata allocation results in a reasonable estimate of the headcount costs associated with each of the programs noted above.
Previous wording
The $0.4 million decrease in general and administrative expenses during the nine months ended March 31, 2025, as compared to the same period ended in 2024, was due to decreases in headcount-related and consulting costs of $0.5 million resulting from the streamlining of operations upon completion of the redomiciliation, combined with a decrease in insurance costs post-redomiciliation of $0.4 million, partially offset by an increase in professional services of $0.5 million to complete the redomiciliation process as compared to the nine months ended March 31, 2024.
Current wording
The $0.2 million increase in general and administrative expenses during the three months ended September 30, 2025, as compared to the same period ended in 2024, was due to an increase in headcount costs of $0.2 million and outside contractor costs of $0.6 million, partially offset by decreases in professional services of $0.6 million resulting from redomiciliation costs experienced during the three months ended September 30, 2024 as compared to the same period ended in 2025.
Previous wording
The net increase in other income of $4.1 million for the nine months ended March 31, 2025, as compared to the same period ending in 2024, was primarily due to an increase in other income for the fair value adjustment associated with our accompanying warrant liability of $3.3 million, an increase in other income associated with research and development incentive awards of approximately $0.2 million, and a gain on foreign currency transactions of approximately $0.7 million, partially offset by a decrease in interest income of approximately $0.1 million.
Current wording
The net decrease in other income of $6.9 million for the three months ended September 30, 2025, as compared to the same period ending in 2024, was primarily due to the fair value adjustment associated with our accompanying warrant liability of $7.2 million, partially offset by an increase in interest income of $0.1 million and changes in losses associated with foreign currency transaction of $0.2 million.
Previous wording
We did not have during the nine months ended March 31, 2025, nor we do not currently have, any off-balance sheet financing arrangements or any relationships with unconsolidated entities or financial partnerships, including entities sometimes referred to as structured finance or special purpose entities, that were established for the purpose of facilitating off-balance sheet arrangements or other contractually narrow or limited purposes.
Current wording
We did not have during the three months ended September 30, 2025, nor we do not currently have, any off-balance sheet financing arrangements or any relationships with unconsolidated entities or financial partnerships, including entities sometimes referred to as structured finance or special purpose entities, that were established for the purpose of facilitating off-balance sheet arrangements or other contractually narrow or limited purposes.
Previous wording
We have incurred significant operating losses and negative cash flows from operations since our inception, and we anticipate that we will incur net losses for the next several years. As of March 31, 2025, we had cash and cash equivalents of $17.0 million and an accumulated deficit of $169.5 million.
Current wording
We have incurred significant operating losses and negative cash flows from operations since our inception, and we anticipate that we will incur net losses for the next several years. As of September 30, 2025, we had cash and cash equivalents of $13.6 million and an accumulated deficit of $188.3 million.
Previous wording
The net cash provided by (used in) operating activities for the nine months ended March 31, 2025 and 2024 was approximately $3.7 million and $(11.7) million, respectively, and represents an increase in cash provided by operations of approximately $15.3 million during the nine months ended March 31, 2025, as compared to the same period ending in 2024. The increase in cash provided by operations is directly due to the $15.7 million of license revenue received and recognized during the nine months ended March 31, 2025, as compared to the same period ended in 2024.
Current wording
The net cash used in operating activities for the three months ended September 30, 2025 and 2024 was approximately $3.8 million and $4.4 million, respectively, and represents a decrease in cash used in operations of approximately $0.6 million during the three months ended September 30, 2025, as compared to the same period ending in 2024. The decrease in cash used in operations is due to an increase in net loss of $9.1 million and changes in the effect of foreign currency remeasurement of $0.2 million, partially offset by the non-cash effect of warrant liability fair value adjustments of $7.4 million, share-based compensation expense of $0.1 million, and changes in working capital of $2.6 million during the three months ended September 30, 2025, as compared to the same period ended in 2024.
Previous wording
There were no transactions categorized as investing activities during either of the nine months ended March 31, 2025 and 2024.
Current wording
There were no transactions categorized as investing activities during either of the three months ended September 30, 2025 and 2024.
Previous wording
Financing activities in the nine months ended March 31, 2025 represent issuance of shares, net of associated issue costs, associated with the utilization of our at-the-market ("ATM") facility.
Current wording
Financing activities in the three months ended September 30, 2025 represent issuance of shares, net of associated issue costs, associated with the utilization of our at-the-market ("ATM") facility.
Previous wording
Financing activities in the nine months ended March 31, 2024 represent the issuance of ADS shares pursuant to the ATM facility, net of issue costs of $0.9 million.
Current wording
Financing activities in the three months ended September 30, 2024 represent residual issue costs associated with the issuance of ADS shares pursuant to the ATM facility.
Previous wording
Based upon the Company’s current operating plans, the Company believes that its existing cash and cash equivalents will be sufficient to continue funding its development activities into the first quarter of fiscal year 2027, which is more than twelve months from the date these condensed consolidated financial statements are issued. Consequently, management has determined there is no substantial doubt regarding the Company's ability to continue as a going concern for the twelve-month period from the date these financial statements are issued.
Current wording
Based upon the Company’s current operating plans, the Company believes that its existing cash and cash equivalents will be sufficient to continue funding its development activities beyond the second quarter of fiscal year 2027, which is more than twelve months from the date these condensed consolidated financial statements are issued. Consequently, management has determined there is no substantial doubt regarding the Company's ability to continue as a going concern for the twelve-month period from the date these financial statements are issued.
Previous wording
If we were unable to obtain additional financing to fund our operations through successful development and commercialization of all our potential product candidates, we may be required to reduce the scope of, delay, or terminate some or all of our planned development and commercialization activities, which could harm our business. For more information as to the risks associated with our future funding requirements, see “Risk Factors.”
Current wording
For more information as to the risks associated with our future funding requirements, see “Risk Factors.”
Previous wording
We do not have any long-term debt or capital lease obligations. We have a long-term operating lease obligation for our Australian office space and a non-current warrant liability which commits us to issuing shares to accompanying warrant holders upon the exercise of their ADS warrants.
Current wording
We do not have any long-term debt or capital lease obligations. We have a current operating lease obligation for our Australian office space and a non-current warrant liability which commits us to issuing shares to accompanying warrant holders upon the exercise of their warrants.
Rearranged current paragraphs (3)
Current report — wording carried from elsewhere
Based upon the Company’s current operating plans, the Company believes that its existing cash and cash equivalents will be sufficient to continue funding its operating activities beyond the second quarter of fiscal year 2027, which is more than twelve months from the date these condensed consolidated financial statements are issued. Consequently, management has determined there is no substantial doubt regarding the Company's ability to continue as a going concern for the twelve-month period from the date these financial statements are issued.
Current report — wording carried from elsewhere
Comparison of the three months ended September 30, 2025 and 2024
Current report — wording carried from elsewhere
The Company has based projections of operating capital requirements on the current operating plan, which management believes can be effectively implemented. The operating plan incorporates several assumptions that may prove to be incorrect, and the Company may use all available capital resources sooner than the Company expects. The accompanying condensed consolidated financial statements do not include adjustments that might result from the outcome of uncertainties and assumes the Company will continue as a going concern through the realization of assets and satisfaction of liabilities and commitments in the ordinary course of business.
Rearranged previous paragraphs (2)
Previous report — wording carried elsewhere
The net decrease in other income of $0.4 million for the three months ended March 31, 2025, as compared to the same period ending in 2024, was primarily due to the fair value adjustment associated with our accompanying warrant liability.
Previous report — wording carried elsewhere
During the nine months ended March 31, 2025, approximately 80% of the total research and development expenses related to the advancement of our BNC210-based programs. Of the total BNC210-based program spend during the nine months ended March 31, 2025, approximately 15% was attributable to PSTD ATTUNE and 65% to SAD Prevail. We do not track labor associated with each program and have allocated headcount costs on a pro-rated basis. Management believes the pro rata allocation results in a reasonable estimate of the headcount costs associated with each of the programs noted above.