NASDAQ: NEUP

Proposed Merger with Scancell Holdings plc

On July 23, 2026, we entered into an Agreement and Plan of Merger (the "Merger Agreement") with Scancell and Scancell Merger Sub, Inc., an indirect wholly owned subsidiary of Scancell ("Merger Sub"). Subject to the terms and conditions of the Merger Agreement, Merger Sub will merge with and into Neuphoria, with Neuphoria surviving the merger as an indirect wholly owned subsidiary of Scancell (the "Merger").

At the effective time of the Merger, if consummated, each outstanding share of our common stock, other than excluded shares, will be converted into the right to receive a number of Scancell American Depositary Shares determined in accordance with the Merger Agreement and one contingent value right ("CVR"). Each CVR will represent a contractual right to receive a pro rata share of certain net proceeds, if any, received after closing under the Merck agreement, the CTx CRC arrangements (including the existing KAT6 license with Pfizer), certain permitted monetizations of specified Neuphoria intellectual property, and Neuphoria's Australian research and development tax credit for the fiscal year ended June 30, 2026. There can be no assurance that any CVR holder will receive a payment.

Completion of the Merger is subject to customary closing conditions, including approval by Neuphoria's stockholders and Scancell's shareholders, effectiveness of a registration statement on Form F-4, approval of the listing of Scancell's American Depositary Shares on Nasdaq, receipt by Scancell of at least $75.0 million in gross proceeds from the concurrent financing, and Neuphoria having at least $10.0 million of closing net cash as of December 31, 2026 or the closing, if earlier. The parties announced they expect the transactions to close in late calendar 2026, but there is no assurance they will close, or when. Scancell has stated that, other than de minimis costs to maintain and enforce agreements and intellectual property, it does not intend to develop Neuphoria's non-partnered assets after closing. See Note 20, “Subsequent Events”, for a more detailed description of the proposed Merger with Scancell, as well as copies of the relevant agreements related to the proposed Merger, each of which is incorporated by reference as an exhibit to this Annual Report on Form 10-K.

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Current Portfolio Status

Program or Asset

Current Status

Control and Potential Economics

BNC210 - PTSD

Program clinic-ready; no active clinical trial, only minor internal development activity. ATTUNE met its Phase 2b primary endpoint.

Neuphoria-owned. Future development would require financing and a decision to resume or partner the asset; Scancell has stated it does not intend to develop non-partnered Neuphoria assets after the Merger.

Merck alpha7 Positive Allosteric Modulators

MK-1167 Phase 2 Alzheimer's disease trial terminated; MK-4334 has completed Phase 1 studies.

Merck controls and funds development. Neuphoria may receive additional milestones and tiered royalties.

CTx CRC / Pfizer KAT6

Pfizer-controlled program entered Phase 3; Neuphoria received a A$1.416 million distribution in May 2026.

Passive interest in future CTx CRC distributions, at a blended rate of 4.65%, if any are disbursed.

Carina CNA3103

Carina-controlled LGR5-targeted CAR-T candidate in a Phase 1/2a trial in metastatic colorectal cancer.

Potential development and regulatory milestones, royalties and a share of certain sublicensing revenue.

BNC210

BNC210 is an orally administered small molecule that selectively negatively modulates the alpha7 receptor. We historically evaluated BNC210 in acute and chronic treatment settings, including SAD and PTSD. We have discontinued the SAD program; no BNC210 clinical trial is active. Clinical and preclinical results obtained before the restructuring indicated that BNC210 may have several potential attributes relative to therapies commonly used for anxiety and stressor-related disorders, including:

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Fast-acting anxiolytic with the potential to be used in both acute and chronic settings;

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non-sedating;

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no addictive effect and a lack of discontinuation/withdrawal syndrome;

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no memory impairment;

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no impairment of motor coordination; and

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no suicidality liability.

BNC210 has been evaluated in 15 clinical trials involving healthy volunteers, elderly patients with agitation, and patients with generalized anxiety disorder ("GAD"), SAD, and PTSD. Across these studies, BNC210 was generally well tolerated following both acute and chronic dosing.

In prior clinical trials involving patients with GAD and healthy subjects exposed to a panic model, we observed three principal findings:

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statistically significant reductions in amygdala hyperactivity when subjects were exposed to fear-inducing triggers;

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statistically significant reductions in defensive behavior in a head-to-head study in which lorazepam did not produce a significant reduction; and

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statistically significant reductions in the intensity and total number of panic symptoms.

We developed a proprietary tablet formulation of BNC210 intended to overcome the food effect observed with the earlier liquid suspension and to provide more predictable exposure in an outpatient setting. We evaluated the tablet formulation in pharmacokinetic studies and used it in the Phase 2 PREVAIL trial in SAD, the Phase 2b ATTUNE trial in PTSD, and the Phase 3 AFFIRM-1 trial in SAD.

In December 2022, we announced results from the Phase 2 PREVAIL trial in SAD. PREVAIL did not meet its prespecified primary endpoint, although post hoc analyses showed signals that informed the Phase 3 AFFIRM-1 design. The PREVAIL results were published in Psychiatry Research in 2025. AFFIRM-1 enrolled approximately 332 adults with SAD and evaluated a single 225 mg dose of BNC210 against placebo during a public-speaking challenge. On October 20, 2025, we announced that AFFIRM-1 did not meet its primary endpoint and that its secondary efficacy analyses showed no statistically significant differences or improvement over placebo. The safety and tolerability profile was consistent with prior studies. Based on these results, we discontinued further development of BNC210 for SAD.

Before AFFIRM-1, we completed an End-of-Phase 2 meeting with the Food and Drug Administration (" FDA") regarding a potential registrational program for SAD. Those discussions are historical and we have no current plan to further develop BNC210 for SAD.

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In September 2023, we announced results from ATTUNE, a double-blind, placebo-controlled Phase 2b trial conducted at 34 sites in the United States and the United Kingdom. The trial enrolled 212 patients, randomized 1:1 to receive BNC210 900 mg twice daily as monotherapy or placebo for 12 weeks. ATTUNE met its primary endpoint of change from baseline in Clinician-Administered PTSD Scale for DSM-5 (CAPS-5) total symptom severity score at Week 12 (p=0.048). Statistically significant differences were also observed at Week 4 (p=0.016) and Week 8 (p=0.015). At Week 12, BNC210 also produced statistically significant improvements in depressive symptoms measured by the Montgomery-Asberg Depression Rating Scale ("MADRS") (p=0.041) and sleep measured by the Insomnia Severity Index ("ISI") (p=0.039).

In July 2024, following an End-of-Phase 2 meeting, we announced that the FDA had provided feedback on a potential path to an NDA submission for BNC210 in PTSD that, together with ATTUNE, contemplated one additional placebo-controlled registrational trial and a 52-week open-label extension. The principal points discussed with the FDA included:

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the FDA agreed that CAPS-5 total symptom severity score and the Clinician Global Impression–Severity scale ("CGI-S") could serve as the primary and key secondary efficacy endpoints, respectively, in a proposed registrational trial;

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the proposed design contemplated evaluating the 900 mg twice-daily dose used in ATTUNE and a lower dose to further characterize the balance of efficacy and safety;

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the FDA and Neuphoria reached high-level agreement on proposed participant characteristics and the methodology for determining sample size; and

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the FDA provided guidance on a proposed hepatic monitoring plan, including monitoring for excessive alcohol consumption.

We did not initiate the planned SYMPHONY Phase 2b/3 trial. The PTSD program maintains clinical readiness, and any future development would depend on available financing and a decision by Neuphoria or a third party to resume the program. If the Merger is completed, Scancell has stated that it does not intend to develop Neuphoria's non-partnered assets, including BNC210, other than incurring de minimis intellectual-property maintenance and enforcement costs.

The FDA previously granted Fast Track designation to BNC210 for PTSD and for the acute treatment of SAD and other anxiety-related disorders. The SAD program has since been discontinued.

Partnered and Legacy Programs

Alpha7 Receptor Positive Allosteric Modulator Program with Merck

In June 2014, we entered into a research collaboration and license agreement with Merck to develop alpha7 receptor positive allosteric modulators “PAMs” targeting cognitive dysfunction associated with Alzheimer's disease and other central nervous system ("CNS") conditions. Merck controls and funds clinical development and worldwide commercialization. The collaboration includes two clinical-stage candidates: MK-1167, which was being evaluated in a Merck-led Phase 2 trial in Alzheimer's disease dementia and was terminated after a planned interim analysis due to lack of efficacy, and MK-4334, which has completed Phase 1 safety and biomarker studies.

On March 19, 2025, we received a $15.0 million milestone payment after Merck initiated the Phase 2 trial of MK-1167 (NCT06721156). Under the agreement, as amended, we may receive up to $450.0 million in additional development and commercial milestone payments associated with multiple candidates, plus tiered royalties on net sales ranging from a low-single-digit percentage to a low-sub-teens percentage, depending on net sales volume.

Because Merck controls the program and our information rights are limited, we cannot predict whether or when any future milestone will be achieved, whether any licensed medicine will be commercialized, or whether we will receive any additional milestone or royalty payments.

Discontinued Internal CNS Preclinical Programs

As part of our fiscal 2026 restructuring, we stopped active work on all internally conducted preclinical programs. These assets include next-generation alpha7 receptor negative allosteric modulators ("NAMs") and programs directed to Kv3.1/3.2 and Nav1.7/1.8 ion channels. We now incur only limited costs to maintain selected intellectual property and contractual rights. Those programs did not advance into clinical development.

We have no current plan to advance these assets internally. Any future development would require a third-party licensee, purchaser or other strategic counterparty. If the Merger is completed, Scancell has stated that it does not intend to develop Neuphoria's non-partnered assets beyond de minimis intellectual-property maintenance and enforcement activities.

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Legacy Oncology and Other Partnered Assets

Through our participation in the former CTx CRC, we retain a passive economic interest in a KAT6 program licensed to Pfizer. On May 21, 2026, we received an A$1.416 million distribution after dosing began for the first subject in the first Phase 3 trial in ER-positive/HER2-negative metastatic breast cancer. Based on our past contributions, we believe we may be eligible to receive approximately 4.65% of future distributions from the relevant CTx CRC entities, if any. The 4.65% represents a blended rate across two CTx CRC programs to which the Company is a participating party. We are a passive participant and cannot determine whether future milestones will be achieved or whether or when we will receive additional distributions.

In November 2020, we exclusively licensed certain BNC101 intellectual property to Carina Biotech for the development of CAR-T and other adoptive cell therapies. Pursuant to the Carina Biotech License, we are eligible to receive up to A$118 million in certain development, regulatory, and commercial milestone payments if Carina fully develops and markets the new therapy. Carina 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. Carina's LGR5-targeted candidate, CNA3103, entered a Phase 1/2a trial in metastatic colorectal cancer, with patient dosing beginning in December 2023. Carina paid us an A$1.0 million milestone in October 2024. As disclosed in our Quarterly Report on Form 10-Q for the period ended March 31, 2026, we are eligible for approximately A$2.0 million of additional development and regulatory milestones if Carina advances the program to Phase 2 and A$3.0 million of additional development and regulatory milestones if Carina advances the program to Phase 3, as well as royalties on net sales and a share of certain sublicensing revenue. Carina controls development and regulatory activities.

Our other legacy oncology asset, BNC105, is a vascular-disrupting tubulin polymerization inhibitor that has been evaluated in six clinical trials. We are not actively developing BNC105 and would seek to realize value, if any, only through a third-party transaction.

Our Strategy

In light of our restructuring and the execution of the Merger Agreement with Scancell, the principal elements of our current strategy are:

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Complete the proposed Merger. We are working with Scancell to satisfy the closing conditions in the Merger Agreement, obtain the required stockholder and shareholder approvals, complete the SEC registration and Nasdaq listing processes, and close the related financing transactions.

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Preserve cash and maintain essential operations. We intend to limit expenditures to those required to complete the Merger, satisfy our obligations as a public company, preserve material contractual and intellectual-property rights, and maintain an orderly corporate infrastructure.

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Protect the value of partnered programs and CVR assets. We will continue to administer our agreements with Merck and the CTx CRC entities, monitor our rights under the Carina Biotech License, maintain selected intellectual property, and pursue the fiscal 2026 Australian research and development tax credit. Certain proceeds received after closing from the Merck and CTx CRC arrangements, specified intellectual property monetizations and the tax credit are expected to be payable to CVR holders, after permitted deductions, under the CVR Agreement.

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Maintain limited internal R&D activities. We maintain clinical readiness of the BNC210 PTSD program in anticipation of the completion of the Merger. If the Merger is not completed, any decision to resume, partner, sell or discontinue an asset would depend on available resources and the strategic alternatives then available.

Scientific Background

Overview of Ion Channels as a Drug Class

Ion channels facilitate the movement of charged molecules across cellular membranes and mediate electrical signaling in the CNS. Modulating ion channels can influence neurotransmission and downstream signaling in the brain. Ion channels are implicated in many diseases, but their complexity has limited successful drug discovery, and only a small portion of disease-associated ion channels have approved medicines directed to them. This biology formed the basis of our historical discovery work in neuropsychiatric and neurological disorders.

Hypercholinergic and Hypocholinergic Disease States

Our historical research focused on identifying small-molecule modulators of ion channels implicated in CNS disorders. Ion channels are membrane-spanning proteins that control the movement of ions into and out of cells and regulate neuronal excitability and signaling (Figure 1).

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Alpha7 Nicotinic Acetylcholine Receptor as a Target

The α7 receptor is a member of the cys-loop, ligand-gated, ion channel superfamily, which includes several other nicotinic receptor subtypes as well as GABA-A, glycine and 5-HT3 receptors. The α7 receptor is unique because of its high calcium ion (“Ca2+”) permeability and rapid desensitization. It is highly expressed in brain regions associated with cognitive performance, such as the basal forebrain, hippocampus and prefrontal cortex, as well as regions associated with emotional control, such as the amygdala and hippocampus. When the acetylcholine ("ACh") neurotransmitter binds to the α7 receptor, the ion channel opens and preferentially allows calcium ions to flow into the cell. These calcium ions act as secondary messengers and trigger signaling cascades, including release of additional neurotransmitters, that contribute to the important CNS modulatory role of this receptor.

Dysfunction of the α7 receptor and altered levels of ACh have been associated with a broad array of neuropsychiatric and neurologic disorders such as SAD, GAD, PTSD, Cognitive Impairment Associated with Schizophrenia (“CIAS”), Attention Deficit Hyperactivity Disorder (“ADHD”) and Alzheimer’s disease. Excess levels of ACh in brain regions involved in emotional control, such as the amygdala and the neocortex, can cause symptoms of anxiety and depression. While stress-induced ACh release can facilitate normal adaptive responses to environmental stimuli, known as fight or flight, chronic elevations of ACh signaling may produce maladaptive behaviors culminating in anxiety and stressor-related disorders such as SAD, GAD and PTSD. Conversely, low ACh levels resulting from loss of cholinergic neurons in brain regions such as the basal forebrain and hippocampus contribute to cognitive deficits in Alzheimer’s disease (Figure 1).

Figure 1: CNS conditions with acetylcholine imbalance at the α7 receptor.

Our Approach: Allosteric Modulation of the α7 Receptor and Clinical Biomarkers

Historically, our discovery and development work focused on negative and positive allosteric modulators of the alpha7 receptor for anxiety-, stress-, and cognition-related disorders. Allosteric sites on ion channels are distinct from the orthosteric site at which acetylcholine binds. Modulating an allosteric site may alter a receptor's response to naturally occurring acetylcholine without directly activating the orthosteric site.

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Figure 2: Structure of the α7 receptor showing the orthosteric and allosteric binding sites.

The α7 receptor has garnered significant attention as a target for cognitive deficits because of its receptor localization, the robust effects observed in preclinical studies, and the genetic implications of its involvement in cognitive disorders. Historically, therapeutics that modulate the α7 receptor have either targeted the orthosteric agonist sites or blocked the channel. These conventional orthosteric α7 receptor agonists have suffered from off-target activity, receptor desensitization, and a narrow therapeutic window, limiting their clinical utility. Allosteric modulators of the α7 receptor bind at the transmembrane region (see Figure 2) at sites distinct from the orthosteric sites. Allosteric modulators on their own have no effect on the receptor and act only when agonists, such as ACh, nicotine or choline, are bound to the orthosteric site. Binding to allosteric sites on the α7 receptor can diminish or enhance the effects of orthosteric agonist binding. Through dynamic interactions between molecules bound to each site, allosteric modulators “normalize” ion-channel function by mitigating hypercholinergic and hypocholinergic disease states (see Figure 2). As such, allosteric modulators offer several potential advantages, including improved safety profiles and a lower likelihood of desensitization, potentially resulting in greater efficacy than historically used orthosteric agonists or channel blockers.

We used our ion-channel biology capabilities to identify orally active, selective small-molecule alpha7 receptor allosteric modulators designed to penetrate the blood-brain barrier. This work produced BNC210 and the alpha7 PAM program, which we licensed to Merck.

Our prior clinical-development approach incorporated translational tools including electroencephalography, functional magnetic resonance imaging, behavioral paradigms, and standardized clinical scales. We used these tools to evaluate target engagement, pharmacologic activity, and clinical outcomes across the BNC210 development program.

Before the fiscal 2026 restructuring, we developed experience in regulatory interactions, clinical-trial design and execution, and manufacturing scale-up for BNC210. We no longer maintain an internal research and development organization and would need additional personnel, financing, and third-party support to resume development of any non-partnered asset.

BNC210: Clinical History and Current Status

BNC210 for Post-Traumatic Stress Disorder and Social Anxiety Disorder

BNC210 is an orally administered, selective NAM of the alpha7 receptor. It does not bind to the orthosteric acetylcholine site and, based on our preclinical work, is designed to reduce excessive receptor signaling while preserving physiological signaling. We

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historically developed BNC210 for the acute treatment of SAD and the chronic treatment of PTSD. Following AFFIRM-1, we discontinued the SAD program. The PTSD program is clinic-ready, and no BNC210 clinical trial is active.

Figure 3. Action of BNC210

PREVAIL, our Phase 2 SAD trial, did not meet its prespecified primary endpoint. Post hoc analyses showed signals that informed the design of AFFIRM-1, but those analyses were exploratory. AFFIRM-1 was a randomized, double-blind, placebo-controlled Phase 3 trial in approximately 332 adults with SAD that evaluated a single 225 mg dose of BNC210 before a public-speaking challenge. AFFIRM-1 did not meet its primary endpoint, and secondary efficacy analyses did not show statistically significant differences or improvement over placebo. The safety and tolerability profile remained consistent with prior studies. We discontinued the SAD program and did not initiate AFFIRM-2.

ATTUNE, our 212-patient Phase 2b trial in PTSD, met its primary endpoint at Week 12 and showed statistically significant differences at Weeks 4 and 8. In a June 2024 End-of-Phase 2 meeting, the FDA provided feedback on a potential registrational path that contemplated one additional placebo-controlled trial and a 52-week open-label extension. The principal points discussed with the FDA included:

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the FDA agreed that CAPS-5 total symptom severity score and CGI-S could serve as the primary and key secondary efficacy endpoints, respectively, in a proposed registrational trial;

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the proposed design contemplated evaluating the 900 mg twice-daily dose used in ATTUNE and a lower dose to further characterize the balance of efficacy and safety;

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the FDA and Neuphoria reached high-level agreement on proposed participant characteristics and the methodology for determining sample size; and

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the FDA provided guidance on a proposed hepatic monitoring plan, including monitoring for excessive alcohol consumption.

We did not initiate the planned SYMPHONY Phase 2b/3 trial. The PTSD program remains clinic-ready while we pursue the Merger, and we do not expect to resume clinical trials before closing. If the proposed Merger closes, Scancell has stated that it does not intend to develop BNC210 beyond de minimis intellectual-property maintenance and enforcement activities.

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Disease Background and Key Disease Drivers

Post-Traumatic Stress Disorder

Post-Traumatic Stress Disorder is a serious, chronic mental health condition triggered by a trauma such as experiencing or witnessing actual or threatened death, serious injury, or sexual violence. While historically misunderstood as stemming primarily from traumatic experiences of military personnel in combat, PTSD can also stem from a broad range of other experiences such as a natural disaster, a car accident, repeated exposure to traumatic events as a first responder, childhood trauma, and sexual assault. Trauma exposure can trigger a distinctive pattern of persistent, disabling behavioral and physiological symptoms, which include intrusive memories and nightmares of the trauma, severe anxiety, irritability, hypervigilance, depression, difficulty sleeping, poor concentration, and emotional withdrawal.

PTSD significantly impacts all aspects of life and the day-to-day functioning of people with this debilitating disorder. In addition, PTSD severity is often worsened by co-occurring disorders that result from PTSD itself such, as major depression, substance abuse, and mood and anxiety disorders. PTSD also substantially contributes to suicide risk, further underscoring the severity and unmet need in this patient population. The CAPS is considered to be the gold-standard criterion measure to diagnose and assess the severity of PTSD symptoms in patients in clinical trials. CAPS is routinely updated to reflect the current DSM criteria, the latest of which is the CAPS-5. This scale measures the frequency and intensity of PTSD symptoms, which can be broadly classified into four clusters: intrusion, avoidance, negative mood and thinking, and arousal and reactivity.

More than 9 million people in the United States are estimated to have PTSD. PTSD is a complex, chronic disorder with multiple symptoms and frequent comorbidities that can make it difficult to treat. Women develop PTSD at a higher rate than men after adjustment for exposure to traumatic events.

Current Treatments for PTSD and Their Limitations

There remains a significant unmet need for improved PTSD treatments. Sertraline and paroxetine are approved by the FDA for PTSD. Other antidepressants and certain anti-anxiety medicines may be used off-label. Existing therapies may have delayed onset, incomplete efficacy, tolerability limitations, or risks that lead patients to discontinue treatment.

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Antidepressants. Selective serotonin reuptake inhibitors and serotonin and norepinephrine reuptake inhibitors are commonly used as first-line pharmacotherapies for PTSD. Many patients do not achieve remission, and these medicines may require several weeks of administration before an effect is observed. Reported adverse effects may include gastrointestinal and CNS effects, sexual dysfunction, and sweating; certain antidepressants also carry a boxed warning concerning suicidality in children, adolescents, and young adults.

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Benzodiazepines. Benzodiazepines are not FDA-approved for PTSD but may be prescribed off-label. They can cause sedation and memory or motor impairment and are associated with risks of misuse, addiction, physical dependence, and withdrawal reactions.

The limitations of existing therapies support the need for PTSD treatments with improved efficacy, response rates, tolerability, and onset of action.

Potential Attributes of BNC210 for PTSD and Other Stressor-Related Disorders

In earlier acute clinical trials, BNC210 showed pharmacologic and anti-anxiety effects without evidence of benzodiazepine-like sedation, cognitive impairment, or addiction potential. These results, together with the ATTUNE findings, suggested the following potential attributes:

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fast acting with the potential to be used in acute and chronic settings;

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non-sedating;

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no addictive effect and lack of discontinuation/withdrawal syndrome;

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no memory impairment;

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no impairment of motor coordination; and

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no suicidality.

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Clinical Development of BNC210

BNC210 has been evaluated in 15 clinical trials involving healthy volunteers and patients with GAD, agitation, SAD and PTSD. The table below summarizes the completed studies. We are not currently conducting a BNC210 clinical trial.

The table below summarizes our completed clinical trials for BNC210:

Phase

Description

Participants / Setting

Subjects Enrolled / Administered BNC210*

BNC210 Formulation and Doses

Location

1

Single Ascending Dose Safety and PK

Healthy volunteers / In-clinic

32/24

Suspension; 5 to 2000 mg

(single dose)

Australia

1

Single Ascending Dose Safety and PK; Food Effect

Healthy volunteers / In-clinic

3-Apr

Suspension; 300 to 2000 mg (single dose)

Australia

1

Single Ascending Dose Safety and PK; Food Effect

Healthy volunteers / In-clinic

47/40

Capsule; 300 to 3000 mg

(single dose)

US

1b

Lorazepam Comparison

Healthy volunteers / In-clinic

24/22

Suspension; 300 and 2000 mg (single dose)

France

1b

CCK-4 Panic Attack Model

Healthy volunteers / In-clinic

60/59

Suspension; 2000 mg

(single dose)

France

1b

Multiple Ascending Dose Safety and PK; Expanded Cohort for EEG Target Engagement

Healthy volunteers / In-clinic

56/44

Suspension; 150 to 1000 mg twice daily for 8 days

France

1

Suspension and Tablet Formulation PK Comparison

Healthy volunteers / In-clinic

6-Jun

Suspension and tablet; 300 mg (single dose)

Australia

1

Single Ascending Dose Safety and PK

Healthy volunteers / In-clinic

5-May

Tablet; 600 to 1200 mg

(single dose)

Australia

1

Multiple Dosing Safety and PK

Healthy volunteers / In-clinic

10-Oct

Tablet; 900 mg twice daily for 7 days

Australia

2a

Imaging and Behavioral Study in Generalized Anxiety Disorder

Generalized anxiety disorder patients / In-clinic

27/25

Suspension; 300 and 2000 mg (single dose)

UK

2a

Agitation in the Elderly in Hospital Setting

Agitated elderly patients / Hospital

38/18

Suspension; 300 mg twice daily for 5 days

Australia

2

RESTORE PTSD

PTSD patients / Out-patient

193/143

Suspension; 150, 300 or 600 mg twice daily for 12 weeks

Australia

2b

ATTUNE PTSD

PTSD patients / Out-patient

212/106

Tablet; 900 mg twice daily for 12 weeks

US, UK

2

PREVAIL SAD

SAD patients / In-Clinic

151/101

Tablet; 225 or 675 mg

(single dose)

US

3

AFFIRM-1 SAD

SAD patients / In-clinic

Approximately 332

Tablet; 225 mg

(single dose)

US

CCK-4 = cholecystokinin tetrapeptide; EEG = electroencephalography; PK = pharmacokinetic.

* The number of enrolled subjects who were administered BNC210; other enrolled subjects were administered placebo or lorazepam only.

Across the completed clinical program, the most commonly reported adverse events among participants receiving BNC210 were headache, somnolence and nausea, and most were mild. In ATTUNE, there were 14 reports of elevated liver function test results among participants receiving 900 mg twice daily. Those findings informed the hepatic monitoring plan discussed with the FDA for a potential subsequent PTSD trial. AFFIRM-1's safety and tolerability profile was consistent with prior studies. In three healthy-volunteer studies using the Addiction Research Center Inventory 49-item questionnaire ("ARCI49"), doses up to 2,000 mg per day for eight days did not show a significant signal across the abuse-potential categories evaluated.

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Phase 1 Clinical Trial Demonstrating Lack of Benzodiazepine-like Side Effects in Healthy Subjects

We conducted a Phase 1 double-blind, placebo-controlled, four-way crossover clinical trial in 24 healthy subjects to evaluate safety and tolerability of BNC210. Subjects received four different treatments in a randomized sequence with a wash-out period of at least seven days between each treatment. The four different treatments consisted of a single dose of placebo, 2 mg lorazepam, 300 mg BNC210 and 2000 mg BNC210. The primary endpoint of the trial was change in attention and the secondary endpoints were changes in visual-motor coordination, emotion, sedation, cognition, ARCI49 and electroencephalographic (“EEG”) activity. BNC210 had no observed effect on measures of attention, visual-motor coordination, addiction, emotion, sedation or cognition. In contrast, lorazepam impaired all parameters.

Phase 1 Clinical Trial Demonstrating Target Engagement in Brain at Nicotinic Receptor in Healthy Subjects

We conducted a Phase 1 clinical trial to demonstrate BNC210 target engagement at brain nicotinic receptors, measured by EEG activity (Figure 4). On Day -1, 24 healthy volunteers received oral nicotine doses ranging from 0.5 to 2.0 mg, after which we measured changes in alpha2 EEG-band power. Subjects then received 2,000 mg of the BNC210 liquid suspension with food for seven days and were rechallenged with nicotine on Day 7. BNC210 significantly reduced nicotine-induced alpha2-band power, which we interpreted as evidence of target engagement and negative modulation of the alpha7 receptor.

Figure 4: BNC210 reduced nicotine-induced quantitative wake EEG responses in the power of the alpha2 band after seven days of dosing compared with predose. * p<0.05, ** p<0.01, *** p<0.001.

Phase 1 and 2 Clinical Trials Demonstrating Anti-Anxiety Effects in Healthy Subjects and Anxiety Patients

We conducted a randomized, placebo-controlled, double-blind Phase 1 clinical trial in 60 healthy subjects to evaluate BNC210's anti-anxiety effects. These subjects were administered cholecystokinin tetrapeptide ("CCK-4"), a peptide that induces anxiety and panic symptoms. CCK-4 induced panic symptoms in 15 subjects, or approximately 25% of the subjects, which is consistent with the CCK-4- induced panic attack rate in other trials. Subjects in a supervised in-clinic setting received a single dose of 2000 mg of BNC210 liquid suspension formulation with food seven hours prior to the CCK-4 challenge. BNC210 demonstrated statistically significant reduction in both the intensity and number of panic symptoms on the Panic Symptoms Scale (“PSS”) compared to placebo 10 minutes after the CCK-4 injection, as seen in Figure 5 (p=0.041 and p=0.048, respectively). This clinical trial also showed a trend for BNC210-treated subjects to return to baseline emotional stability more quickly than placebo-treated subjects. These findings were consistent with our prior preclinical studies in rodents where BNC210 overcame the effects of a CCK-4 challenge and enhanced fear extinction, and showed similar activity to benzodiazepines without the narrow dose-response common to that class of drugs.

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Figure 5: Mean change from baseline for (A) Sum Intensity score (panic symptom intensity) and (B) Total Symptom score (total number of panic symptoms) on the Panic Symptom Scale. *p<0.05 vs. placebo.

We also conducted a Phase 2 randomized, double-blind, placebo-controlled, four-way crossover clinical trial in 24 newly diagnosed, treatment-naive GAD patients in the clinic to evaluate neural imaging responses to “fearful faces” and behavioral responses to threat avoidance. Each subject was treated in a randomized manner with a single dose of 300 mg BNC210, 2000 mg BNC210, 1.5 mg lorazepam or placebo with a washout period of at least five days. The primary endpoints were changes in cerebral perfusion using functional magnetic resonance imaging in the resting state and changes in activation of the brain region responsible for emotional control, the amygdala, during an emotional task. Secondary endpoints were changes in defensive behavior (Flight Intensity) using the Joystick Operated Runway Task (“JORT”) and changes in affective self-report, which are measures of anxiety. BNC210 300 mg, similarly to lorazepam, statistically significantly reduced amygdala reactivity to “fearful faces” relative to placebo (BNC210 300 mg left amygdala p=0.011; BNC210 300 mg right amygdala p=0.006; lorazepam right amygdala p=0.047) (Figure 6A). BNC210 300 mg also statistically significantly reduced connectivity between the amygdala and the anterior cingulate cortex (“ACC”), a network involved in regulating anxious responses to aversive stimuli (p=0.012) (Figure 6B). Furthermore, in this head-to-head study, BNC210 300 mg and 2000 mg significantly reduced the intensity of defensive behavior compared with placebo, whereas lorazepam did not (BNC210 300 mg p=0.007; BNC210 2000 mg p=0.033) (Figure 6C). In addition, the 300 mg dose of BNC210 significantly reduced self-reported anxiety (p=0.003).

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Figure 6: Phase 2 trial in GAD patients. (A) BNC210 300 mg significantly reduced activation of the left and right amygdala while viewing fearful faces; (B) BNC210 300 mg significantly reduced connectivity between the amygdala and ACC while viewing fearful faces; (C) BNC210 300 mg and 2000 mg significantly reduced threat avoidance behavior in the JORT behavioral task.

Novel, Proprietary Tablet Reformulation Effort

The earlier clinical trials discussed above used a liquid suspension formulation that required administration with a high-fat meal to provide optimal absorption. We developed a proprietary tablet formulation to reduce the food effect, improve outpatient dosing and provide more predictable pharmacokinetics. We conducted three clinical pharmacology studies of the tablet formulation, which was subsequently used in PREVAIL, ATTUNE and AFFIRM-1.

We conducted a Phase 1 crossover pharmacokinetic trial in six fasted and fed healthy subjects comparing a single 300 mg dose of the liquid suspension with the tablet formulation. The liquid suspension produced substantially lower exposure when administered fasted than when administered with food (Figure 7). By contrast, the tablet produced similar blood concentrations and exposure in fasted and fed subjects, with the expected delay in time to maximum concentration after a high-fat meal.

A separate seven-day pharmacokinetic study in ten healthy volunteers supported the 900 mg twice-daily regimen used in ATTUNE. Exposure was similar by sex, and BNC210 was generally well tolerated.

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Figure 7: BNC210 tablet formulation overcomes food effect in healthy subjects.

The tablet formulation provided more predictable exposure than the earlier liquid suspension and supported evaluation of the tablet formulation of BNC210 in Phase 2 and 3 acute- and chronic-dosing studies. Across the completed clinical program, BNC210 was generally well tolerated.

BNC210 Clinical Development in PTSD

ATTUNE was a randomized, double-blind, placebo-controlled, parallel-group Phase 2b trial evaluating BNC210 monotherapy in PTSD. The trial enrolled 212 participants at 34 sites in the United States and the United Kingdom. Participants received either BNC210 900 mg twice daily or placebo for 12 weeks. The primary efficacy endpoint was change from baseline in CAPS-5 total symptom severity score at Week 12 (Figure 8).

Figure 8: Phase 2b ATTUNE clinical trial design.

ATTUNE met its primary endpoint at Week 12 (p=0.048), with statistically significant differences also observed at Week 4 (p=0.016) and Week 8 (p=0.015) (Figure 9). At Week 12, BNC210 also produced statistically significant improvements in depressive symptoms

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measured by MADRS (p=0.041) and sleep measured by the ISI (p=0.039) (Figure 10). Other secondary measures, including CGI-S, the Participant Global Impression-Severity scale and the Sheehan Disability Scale, showed signals or trends across visits.

Figure 9: ATTUNE Study – BNC210 significantly reduced change from baseline CAPS-5 total symptom severity scores in patients with PTSD. *p<0.05.

Figure 10: ATTUNE Study – BNC210 significantly reduced change from baseline (A) MADRS depression scores, and (B) ISI scores, compared to placebo. *p<0.05

In July 2024, we announced the outcome of an End-of-Phase 2 meeting with the FDA regarding a potential registrational path for BNC210 in PTSD. The plan discussed with the FDA contemplated one additional placebo-controlled registrational trial with a 52-week open-label extension. The principal points discussed included:

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the FDA agreed that CAPS-5 total symptom severity score and CGI-S could serve as the primary and key secondary efficacy endpoints, respectively, in a proposed registrational trial;

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the proposed design contemplated evaluating the 900 mg twice-daily dose used in ATTUNE and a lower dose to further characterize the balance of efficacy and safety;

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the FDA and Neuphoria reached high-level agreement on proposed participant characteristics and the methodology for determining sample size; and

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the FDA provided guidance on a proposed hepatic monitoring plan, including monitoring for excessive alcohol consumption.

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We did not begin the contemplated Phase 2b/3 program. The PTSD program remains clinic-ready, and we are not conducting start-up or other development activities for the proposed trial.

Potential Future Development of BNC210

BNC210 has been evaluated in several anxiety and stressor-related settings, including PTSD, SAD, GAD and a human model of panic symptoms. We have no active plan to pursue additional indications. Any future development would require financing and a decision by Neuphoria or a third party to resume the program. If the Merger is completed, Scancell has stated that it does not intend to develop BNC210.

Other Programs

Alpha7 Receptor Positive Allosteric Modulator Program ("PAM") for the Treatment of Cognitive Impairment

Treatments for cognitive deficits associated with CNS disorders such as Alzheimer disease and schizophrenia remain significant unmet medical needs that incur substantial pressure on the healthcare system. The α7 receptor has garnered substantial attention as a target for cognitive deficits because of its localization, robust preclinical effects, genetic evidence implicating its involvement in cognitive disorders, and encouraging, albeit mixed, clinical data with α7 receptor orthosteric agonists. Importantly, previous orthosteric agonists at this receptor suffered from off-target activity, receptor desensitization, and an inverted U-shaped dose-response curve in preclinical assays, limiting their clinical utility.

To overcome the challenges with orthosteric agonists, we embarked on an α7 PAM discovery program that led to the identification of BNC375, a novel α7 PAM selective over related receptors that potentiates ACh-evoked α7 currents with no observed effect on receptor desensitization kinetics. In June 2014, we entered into a strategic collaboration with Merck to develop novel PAMs, including our BNC375 research program, to treat cognitive dysfunction associated with Alzheimer’s disease and other central nervous system conditions. Under the collaboration, BNC375 was further characterized showing that it enhanced long-term potentiation of electrically evoked synaptic responses in rat hippocampal slices and in vivo, which is an established preclinical surrogate for memory enhancement. Systemic administration of BNC375 reversed scopolamine-induced cognitive deficits in rat novel object recognition and rhesus monkey object retrieval detour (“ORD”) tasks over a wide range of exposures, showing no evidence of an inverted U-shaped dose-effect curve. The compound also improved performance in the ORD task in aged African green monkeys. African green monkeys display pathological hallmarks of Alzheimer’s disease, such as amyloid plaques, and constitute a valuable translational model to assist in developing drug candidates for Alzheimer’s disease. Moreover, ex vivo 13C-NMR analysis indicated that BNC375 treatment enhanced neurotransmitter release in rat medial prefrontal cortex. These findings suggest that α7 receptor PAMs may offer multiple advantages over orthosteric α7 receptor agonists for treating cognitive dysfunction associated with CNS diseases.

The Merck collaboration includes two clinical-stage alpha7 receptor PAM candidates. MK-4334 has completed Phase 1 safety and biomarker studies in healthy subjects. Merck initiated a Phase 2 trial of MK-1167 in December 2024 to treat symptoms of Alzheimer's disease dementia (NCT06721156). The trial was terminated in June 2026 following a planned interim analysis due to lack of efficacy. Merck controls the program's design, conduct, timing, and reporting.

Discontinued Internal Preclinical Programs

We previously maintained small-molecule discovery programs targeting several ion channels, including next-generation alpha7 receptor NAMs, Kv3.1/3.2, and Nav1.7/1.8. We stopped active work on these programs as part of the fiscal 2026 restructuring.

Our next-generation alpha7 receptor NAM work produced a patented, orally bioavailable small-molecule series that was evaluated preclinically for CNS disorders. None of these assets entered clinical development.

Our Kv3.1/3.2 program produced two patented small-molecule series that were evaluated in preclinical models of cognitive and social-function deficits. We are not advancing these or our other preclinical assets.

Legacy Oncology and Other Partnered Programs

BNC101 is a humanized monoclonal antibody directed to LGR5, a cancer stem-cell receptor expressed in several solid tumors. BNC101 completed a Phase 1 trial in colorectal cancer. In November 2020, we licensed relevant BNC101 intellectual property to Carina Biotech for CAR-T and other adoptive cell therapies. Carina's CNA3103 program is in a Phase 1/2a trial in metastatic colorectal cancer; Carina controls and funds development. Separately, through the former CTx CRC, we retain a passive economic interest in the Pfizer-controlled KAT6 program. We do not direct or fund either program.

BNC105 is a vascular-disrupting tubulin polymerization inhibitor that has been evaluated in six clinical trials. We are not actively developing BNC105 and would seek to realize value from the asset, if any, only through a third-party transaction.

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Competition

The biopharmaceutical industry is highly competitive and subject to rapid technological change. Any potential future development of BNC210 or another asset would face competition from large pharmaceutical and biotechnology companies, specialty and generic drug companies, academic institutions, government agencies and research institutions.

Key competitive factors affecting the commercial success of our drug candidates, if approved, are likely to be efficacy, safety and tolerability profile, reliability, convenience of dosing, the level of branded and generic competition, price, reimbursement and intellectual property protection.

Potential competitors may have substantially greater financial, technical and human resources and more experience developing product candidates, obtaining regulatory approvals and commercializing products. These advantages could allow competitors to develop or market products more rapidly or effectively than we or any future licensee could.

If development of BNC210 is resumed, competing therapies may obtain regulatory approval sooner, demonstrate better efficacy or tolerability, or achieve broader market acceptance. Any of those outcomes could reduce or eliminate the commercial value of BNC210.

For PTSD, competition includes the following:

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Sertraline and paroxetine are FDA-approved generic antidepressants for PTSD. Other antidepressants may be recommended in treatment guidelines or prescribed off-label. Academic and industry sponsors are also evaluating pharmacologic and nonpharmacologic approaches with mechanisms different from approved selective serotonin reuptake inhibitors ("SSRIs").

Manufacturing

We do not own manufacturing facilities or employ manufacturing personnel. We relied on third-party contract manufacturers to produce BNC210 drug substance and drug product for clinical trials. No manufacturing is currently being performed for an active Neuphoria-sponsored development program. BNC210 is a small molecule manufactured through a synthetic process using commercially available starting materials. The process does not require highly specialized manufacturing equipment; however, any future clinical or commercial supply would remain subject to vendor qualification, regulatory requirements, and available financing.

Commercialization

We have not established a commercial organization or distribution capabilities. Because of the status of our internal programs and our pursuit of the Merger, we have no current plan to build a sales, marketing, or distribution organization for BNC210. Any future commercialization would require a decision to resume development, regulatory approval, substantial additional capital, and either new internal capabilities or a commercial partner.

Research Collaboration and License Agreement with Merck

In June 2014, we entered into a research collaboration and license agreement with Merck to develop alpha7 receptor PAMs targeting cognitive dysfunction associated with Alzheimer's disease and other CNS conditions. Merck controls and funds clinical development and worldwide commercialization of licensed products. The collaboration includes MK-4334, which has completed Phase 1 studies, and MK-1167, which was evaluated in a now-terminated Merck-led Phase 2 trial in Alzheimer's disease dementia following an interim efficacy analysis.

On March 19, 2025, we received a $15.0 million milestone payment triggered by Merck's initiation of the Phase 2 trial of MK-1167 (NCT06721156). Under the agreement, as amended, we may receive up to $450.0 million in additional development and commercial milestone payments associated with multiple candidates, plus royalties on net sales of licensed medicines.

Merck controls the program, and we cannot predict whether or when future milestones will be achieved or whether any licensed product will be approved or commercialized. Our information rights are limited, and we depend on Merck for updates concerning development, safety and regulatory matters.

The Merck agreement grants Merck an exclusive license in the applicable territory under specified Bionomics patent rights and know-how, with rights to sublicense, research, develop, manufacture and commercialize licensed compounds and products in the defined field.

Future milestone and royalty revenue, if any, will be recognized in accordance with applicable accounting standards when the relevant recognition criteria are satisfied.

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On March 14, 2025, Merck and the Company executed the fifth amendment to the agreement. The amendment revised the patent royalty rate so that, subject to specified net-sales thresholds, royalties range from a low-single-digit percentage to a low-sub-teens percentage depending on net-sales volume.

CTx CRC and KAT6 Program

We participated in the former CTx CRC, which commercialized drug-discovery projects on behalf of its participants. Pfizer licensed a KAT6 program, which it now controls. On May 21, 2026, we received an A$1.416 million distribution after dosing the first subject in the first Phase 3 trial in ER-positive/HER2-negative metastatic breast cancer. Based on our past program contributions, we believe we may be eligible to receive approximately 4.65% of future distributions from the relevant CTx CRC entities, if any. The 4.65% represents a blended rate across two CTx CRC programs to which the Company is a participating party. We are a passive participant and cannot determine whether future milestones will be achieved, whether future distributions will be made, or the amount or timing of any distribution. Under the CVR Agreement to be entered into in connection with the Merger, certain net proceeds received after closing from the CTx CRC arrangements during the applicable period are expected to be payable to CVR holders, subject to the terms and deductions in that agreement.

IP License Agreement with Carina Biotech

In November 2020, we entered into an IP license agreement (the “Carina Biotech License”) with Carina. Pursuant to the Carina Biotech License, we granted Carina an exclusive, worldwide license, with the right to grant sublicenses (subject to certain restrictions), under certain of our patents and know-how to research, develop, make, have made, use, sell, offer for sale, supply, cause to be supplied, import and otherwise exploit products applying the licensed patents and/or licensed know-how for research, commercial and development applications, and related fields, with respect to CAR-T cells, adaptor CARs and other adoptive cell therapies.

Under the Carina Biotech License, Carina is obligated to use commercially reasonable efforts to commercially develop and exploit licensed products in each country in which Carina obtains regulatory approval for the licensed products. Carina is responsible for conducting all regulatory activities for the licensed products. We are obligated to assist Carina as reasonably requested from time to time in connection with its regulatory filings. We are also obligated to provide Carina, at its request, with know-how and technical information useful or necessary for Carina to fully exercise the rights licensed to it under the agreement.

Pursuant to the Carina Biotech License, we are eligible to receive up to A$118 million in certain development, regulatory and commercial milestone payments if Carina fully develops and markets the new therapy. Carina 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. Carina's LGR5-targeted candidate, CNA3103, entered a Phase 1/2a trial in metastatic colorectal cancer, with patient dosing beginning in December 2023. Carina paid us an A$1.0 million milestone in October 2024. As disclosed in our Quarterly Report on Form 10-Q for the period ended March 31, 2026, we are eligible for approximately A$2.0 million of additional development and regulatory milestones if Carina advances the program to Phase 2 and A$3.0 million of additional development and regulatory milestones if Carina advances the program to Phase 3. Carina controls the timing, conduct and reporting of the program.

Carina is also obligated to pay royalties on net sales of licensed products, generally ranging from the low-single digits to the mid-single digits, subject to specified deductions, and we may receive a percentage of certain sublicensing revenue.

The Carina Biotech License expires upon the later of the expiration of all licensed patents with a valid claim covering licensed products and the expiration of all data exclusivity relating to the licensed products. Carina Biotech may terminate this agreement without cause on 90 days’ written notice. Either party may terminate the agreement for cause in the event of the other party’s insolvency or on 30 days’ notice in the event of the other party’s material breach of the agreement. In the event that a party terminates the agreement, the license granted to Carina Biotech will be terminated, and Carina Biotech will cease its development and exploitation of the licensed products except that Carina Biotech will have the right for 18 months to sell any inventory of licensed products existing as of the termination date.

Research and License Agreement with Ironwood Pharmaceuticals

In January 2012, we entered into a research and license agreement with Ironwood Pharmaceuticals, Inc. (“Ironwood”), pursuant to which Ironwood was granted worldwide development and commercialization rights for BNC210. In November 2014, the parties mutually agreed to terminate this license agreement, reverting all rights to BNC210 back to us. The sole obligation to Ironwood is to pay low-to-mid-single digit royalties on the net sales of BNC210, if commercialized.

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Intellectual Property

Central Nervous System

As of June 30, 2026, we owned more than 15 issued U.S. patents, one pending U.S. patent application, two pending Patent Cooperation Treaty applications, more than 30 granted foreign patents and more than 10 pending foreign patent applications in our CNS intellectual-property portfolio.

With regard to our BNC210 product candidate, we own:

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one patent family with claims directed to the compositions of matter of BNC210, methods of preparing BNC210, and methods of treating anxiety and depressive disorders using BNC210, which are expected to expire in, 2027, excluding any possible patent term adjustments or extensions and assuming payment of all appropriate maintenance, renewal, annuity or other governmental fees, as applicable; this family includes patents granted in the U.S. as well as Australia, Canada, France, Germany, the United Kingdom, and Japan.

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one patent family with claims directed to the manufacture and method of preparing BNC210, which are expected to expire in 2032, excluding any possible patent term adjustments or extensions and assuming payment of all appropriate maintenance, renewal, annuity or other governmental fees, as applicable; this family includes patents granted in the U.S. as well as Australia, Canada, the United Kingdom, Germany, and Japan;

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one patent family with claims directed to the crystalline form of BNC210, which are expected to expire in 2033, excluding any possible patent term adjustments or extensions and assuming payment of all appropriate maintenance, renewal, annuity or other governmental fees, as applicable; this family includes patents granted in the U.S. as well as Australia, Canada, the United Kingdom, Germany, France, Mexico, New Zealand and Hong Kong;

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one patent family with claims directed to the salts, cocrystal and polymorphic form of BNC210, which are expected to expire in 2034, excluding any possible patent term adjustments or extensions and assuming payment of all appropriate maintenance, renewal, annuity or other governmental fees, as applicable; this family includes granted patents in the U.S. and Australia;

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one patent family with claims directed to solid form formulations of BNC210. The patent and patent applications claiming priority to this PCT application, if issued, are expected to expire in 2040, excluding any possible patent term adjustments or extensions and assuming payment of all appropriate maintenance, renewal, annuity or other governmental fees, as applicable; this family includes a patent granted in China and a patent granted in the U.S., as well as multiple patent applications currently pending in Canada, China, Europe, Japan, Korea, Mexico, New Zealand, Israel and Australia; and

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two provisional applications filed with claims directed toward methods of treating social anxiety disorder and post-traumatic stress disorder.

We also have two patent families with claims directed to the composition of matter and their uses for the treatment of cognitive deficits and negative symptoms in schizophrenia and for the treatment of autism spectrum disorders, and are currently granted in the U.S., Europe and Australia; and are pending in Japan, Canada, and New Zealand. Patents issuing from such applications, if any, are expected to expire in 2039, excluding any possible patent term adjustments or extensions and assuming payment of all appropriate maintenance, renewal, annuity or other governmental fees, as applicable.

Oncology

As of June 30, 2026, we owned over 8 issued U.S. patents, one pending U.S. patent application, and over 8 granted foreign patents, in our oncology intellectual property portfolio.

With regard to our BNC101 product candidate, we own three patent families with claims directed to compositions of matter and various methods of treatment using BNC101, with granted patents in the U.S., Australia, France, Germany, Japan, China, India, Korea, New Zealand and Hong Kong, with expiration dates ranging from 2033 to 2039, excluding any possible patent term adjustments or extensions and assuming payment of all appropriate maintenance, renewal, annuity or other governmental fees, as applicable.

We seek to preserve the proprietary technology that may support the value of our remaining assets, including our drug candidates and related manufacturing processes. We maintain patent protection in the United States and internationally where we believe doing so is appropriate, and we also rely on trade secrets and contractual rights.

Our ability to preserve the value of these assets depends in part on maintaining valid and enforceable patent and other proprietary rights, protecting the confidentiality of our trade secrets, and avoiding infringement of third-party rights. Following the fiscal 2026

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restructuring, our intellectual-property activities are focused on maintaining and enforcing selected existing rights rather than supporting active internal research programs.

We cannot be sure that patents will be granted with respect to any of our pending patent applications or with respect to any patent applications we may own or license in the future, nor can we be sure that any of our existing patents or any patents we may own or license in the future will be useful in protecting our technology. For this and more comprehensive risks related to our intellectual property, please see “Risk Factors—Risks Relating to Protecting Our Intellectual Property.” The term of an individual patent depends upon the legal term of the patent in the country in which it is obtained. In most countries in which we file, the patent term is 20 years from the date of filing the non-provisional priority application. Because any regulatory approval for a drug often occurs several years after the related patent application is filed, the resulting market exclusivity afforded by any patent on our drug candidates and technologies will likely be substantially less than 20 years. In the United States, a patent’s term may be lengthened by patent term adjustment, which compensates a patentee for administrative delays by the United States Patent and Trademark Office (“USPTO”) in granting a patent or may be shortened if a patent is terminally disclaimed over an earlier-filed patent. The term of a U.S. patent that covers an FDA-approved drug may also be eligible for patent term extension, which permits patent term restoration as compensation for the patent term lost during the FDA regulatory review process. A patent term extension of up to five years may be granted beyond the expiration of the patent. This period is generally one-half of the time between the effective date of an Investigational New Drug Application ("IND") (falling after issuance of the patent), and the submission date of an NDA, or Biologics License Application ("BLA"), plus the time between the submission date of an NDA and the approval of that application, provided the sponsor acted with diligence. A patent term extension cannot extend the remaining term of a patent beyond a total of 14 years from the date of drug approval and only one patent applicable to an approved drug may be extended. The application for patent term extension is subject to approval by the USPTO in conjunction with the FDA. Because these adjustments and extensions require specific requirements, we cannot be assured that our patents will receive adjustments or extensions, even if we encounter significant delays in patent office proceedings or marketing and regulatory approval.

Inflation and Seasonality

Management believes inflation has not had a material impact on our operations or financial condition. Our operations are not currently subject to material seasonal influences because we have no marketed products and no active Neuphoria-sponsored development program.

Government Regulation

The FDA and other regulatory authorities at federal, state and local levels, as well as in foreign countries and local jurisdictions, extensively regulate, and impose substantial and burdensome requirements upon companies involved in, among other things, the research, development, testing, manufacture, quality control, sampling, import, export, safety, effectiveness, labeling, packaging, storage, distribution, record keeping, approval, advertising, promotion, marketing, post-approval monitoring and post-approval reporting of our product candidates. Any drug candidates that we develop must be approved by the FDA before they may be legally marketed in the United States and by the appropriate foreign regulatory agency before they may be legally marketed in those foreign countries. Generally, our activities in other countries will be subject to regulation similar in nature and scope to that imposed in the United States, although there can be important differences. We, along with our vendors, contract research organizations and contract manufacturers, will be required to navigate the various preclinical, clinical, manufacturing and commercial approval requirements of the governing regulatory agencies of the countries in which we wish to conduct studies or seek approval of our product candidates. Obtaining drug regulatory approvals and ensuring subsequent compliance with appropriate federal, state, local, and foreign statutes and regulations requires substantial time and financial resources.

In the United States, the FDA regulates drug products under the Federal Food, Drug, and Cosmetic Act (“FD&C Act”), as amended, its implementing regulations and other laws. If we fail to comply with applicable FDA or other requirements at any time with respect to product development, clinical testing, approval or any other legal requirements relating to product manufacture, processing, handling, storage, quality control, safety, marketing, advertising, promotion, packaging, labeling, export, import, distribution, or sale, we may become subject to administrative or judicial sanctions or other legal consequences. These sanctions or consequences could include, among other things, the FDA’s refusal to approve pending applications, issuance of clinical holds for ongoing studies, withdrawal of approvals, warning or untitled letters, product withdrawals or recalls, product seizures, relabeling or repackaging, total or partial suspensions of manufacturing or distribution, injunctions, fines, civil penalties or criminal prosecution.

The process required by the FDA before a drug may be marketed in the United States generally involves the following:

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completion of extensive preclinical laboratory tests, animal studies and formulation studies in accordance with good laboratory practice (“GLP”), requirements and other applicable regulations;

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submission to the FDA of an IND application, which must become effective before clinical trials may begin;

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approval by an Institutional Review Board (“IRB”) or independent ethics committee at each clinical trial site before each trial may be initiated;

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performance of adequate and well-controlled clinical trials in accordance with applicable IND regulations, good clinical practice (“GCP”) requirements and other regulations, to establish the safety and efficacy of the investigational product for its intended use;

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submission to the FDA of an NDA, after completion of all pivotal trials;

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a determination by the FDA within 60 days of its receipt of an NDA, to accept the filing for review;

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satisfactory completion of an FDA advisory committee review, if applicable;

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satisfactory completion of one or more FDA pre-approval inspections of the manufacturing facility or facilities where the drug will be produced to assess compliance with current good manufacturing practice (“cGMP”) requirements to assure that the facilities, methods and controls are adequate to preserve the drug’s identity, strength, quality and purity;

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potential FDA audit of the clinical trial sites that generated the data in support of the NDA;

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payment of user fees for FDA review of the NDA; and

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FDA review and approval of the NDA to permit commercial marketing or sale of the drug for particular indications for use in the United States.

Preclinical Studies and Clinical Trials for Drugs

Before testing any drug in humans, the product candidate must undergo rigorous preclinical testing. Preclinical studies include laboratory evaluations of drug chemistry, formulation and stability, as well as in vitro and animal studies to assess safety and in some cases to establish the rationale for therapeutic use. Preclinical studies are subject to federal and state regulations and requirements, including GLP requirements for safety/toxicology studies. The results of the preclinical studies, together with manufacturing information and analytical data must be submitted to the FDA as part of an IND. An IND is a request for authorization from the FDA to administer an investigational product to humans and must become effective before clinical trials may begin. Some long-term preclinical testing may continue even after the IND is submitted. The IND also includes results of animal and in vitro studies assessing the toxicology, pharmacokinetics, pharmacology, and pharmacodynamic characteristics; chemistry, manufacturing, and controls information; and any available human data or literature to support the use of the investigational product. The IND automatically becomes effective 30 days after receipt by the FDA, unless the FDA, within the 30-day time period, raises concerns or questions about the conduct of the clinical trial, including concerns that human research patients will be exposed to unreasonable health risks, and imposes a clinical hold. In such a case, the IND sponsor and the FDA must resolve any outstanding concerns before the clinical trial can begin. Submission of an IND therefore may or may not result in FDA authorization to begin a clinical trial or to commence a clinical trial with the investigational plan originally specified in the IND. Clinical trials involve the administration of the product candidate to human subjects under the supervision of qualified investigators, generally physicians not employed by or under the trial sponsor’s control, in accordance with GCP requirements, which include the requirements that all research subjects provide their informed consent for their participation in any clinical trial. Clinical trials are conducted under protocols detailing, among other things, the objectives of the clinical trial, dosing procedures, subject selection and exclusion criteria and the parameters and criteria to be used in monitoring safety and evaluating effectiveness.

A separate submission to the existing IND must be made for each successive clinical trial conducted during product development, and for any subsequent amendments to the protocol. Furthermore, an IRB at each institution where the clinical trial will be conducted must review and approve the plan and informed consent form before the trial begins at that site and must monitor the study until completion. An IRB is charged with protecting the welfare and rights of trial participants and considers whether the risks to individuals participating in clinical trials are minimized and are reasonable in relation to the anticipated benefits. Regulatory authorities, including the FDA, as well as the IRB or the sponsor may suspend or discontinue a clinical trial at any time on various grounds, including a finding that the patients are being exposed to an unacceptable health risk or that the trial is unlikely to meet its stated objectives. Some studies also include oversight by an independent group of qualified experts organized by the clinical study sponsor, known as a data safety monitoring board, which provides authorization for whether or not a study may move forward at designated check points based on access to certain data from the study and may halt the clinical trial if it determines that there is an unacceptable safety risk for subjects or other grounds, such as no demonstration of efficacy. There are also requirements governing the reporting of ongoing and completed clinical trials to public registries. Information about applicable clinical trials, including clinical trial results, must be submitted within specific timeframes for publication on the www.clinicaltrials.gov website.

A sponsor who wishes to conduct a clinical trial outside of the United States may, but need not, obtain FDA authorization to conduct the clinical trial under an IND. The FDA will accept a well-designed and well-conducted foreign clinical trial not conducted under an IND if the trial was conducted in accordance with GCP requirements, and the FDA is able to validate the data through an onsite

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inspection if deemed necessary. Human clinical trials are typically conducted in three sequential phases, which may overlap or be combined.

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Phase 1 - Phase 1 clinical trials involve initial introduction of the investigational product into healthy human volunteers or patients with the target disease or condition. These studies are typically designed to test the safety, dosage tolerance, absorption, metabolism and distribution of the investigational product in humans, the side effects associated with increasing doses, and, if possible, to gain early evidence on effectiveness. In the case of some products for severe or life-threatening diseases, such as cancer, especially when the product may be too inherently toxic to ethically administer to healthy volunteers, the initial human testing is often conducted in patients.

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Phase 2 - Phase 2 clinical trials typically involve administration of the investigational product to a limited patient population with a specified disease or condition to evaluate the preliminary efficacy, optimal dosages, dose tolerance and dosing schedule and to identify possible adverse side effects and safety risks. Multiple Phase 2 clinical trials may be conducted to obtain information prior to beginning larger and more expensive Phase 3 clinical trials.

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Phase 3 - Phase 3 clinical trials typically involve administration of the investigational product to an expanded patient population to further evaluate dosage, to provide statistically significant evidence of clinical efficacy and to further test for safety, generally at multiple geographically dispersed clinical trial sites. These clinical trials are intended to establish the overall risk/benefit ratio of the investigational product and to provide an adequate basis for product approval. Generally, the FDA requires two adequate, well-controlled Phase 3 clinical trials to approve an NDA.

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Post-approval trials, sometimes referred to as Phase 4 clinical trials, may be conducted after initial marketing approval. These trials provide additional experience from treating patients in the approved indication. In certain instances, such as with accelerated approval drugs, FDA may mandate the performance of Phase 4 clinical trials as a condition of approval of an NDA.

During the development of a new drug, sponsors are given opportunities to meet with the FDA at certain points. These points are generally prior to submission of an IND, at the End-of-Phase 2, and before an NDA is submitted. Meetings at other times may be requested. These meetings give the sponsor an opportunity to share data gathered to date, the FDA an opportunity to provide advice, and the sponsor an opportunity to obtain the FDA’s feedback on the next phase of development. Sponsors typically use the meetings at the end of the Phase 2 trial to discuss Phase 2 clinical results and present plans for the pivotal Phase 3 clinical trials that they believe will support approval of the new drug.

Concurrent with clinical trials, companies usually complete additional animal studies and must also develop additional information about the chemistry and physical characteristics of the product candidate and finalize a process for manufacturing the product in commercial quantities in accordance with cGMP requirements. The manufacturing process must be capable of consistently producing quality batches of the product candidate and, among other things, manufacturers must develop methods for testing the identity, strength, quality and purity of the final drug product. Additionally, manufacturers must select and test appropriate packaging and conduct stability studies to demonstrate that the product candidate does not undergo unacceptable deterioration over its shelf life. While the IND is active and before approval, progress reports summarizing the results of clinical trials and nonclinical studies performed since the last progress report must be submitted to the FDA at least annually. While the IND is active and before approval, progress reports summarizing the results of the clinical trials and nonclinical studies performed since the last progress report must be submitted at least annually to the FDA. Written IND safety reports must be submitted to the FDA and the investigators fifteen days after the trial sponsor determines the information qualifies for reporting for serious and unexpected suspected adverse events, findings from other studies or animal or in vitro testing that suggest a significant risk for human volunteers and any clinically important increase in the rate of a serious suspected adverse reaction over that listed in the protocol or investigator brochure. The sponsor must also notify the FDA of any unexpected fatal or life-threatening suspected adverse reaction as soon as possible but in no case later than seven calendar days after the sponsor’s initial receipt of the information.

DEA Regulation

The Controlled Substances Act ("CSA") establishes registration, security, recordkeeping, reporting, storage, distribution and other requirements that are administered by the Drug Enforcement Administration ("DEA"). DEA regulates the handlers of controlled substances, as well as the equipment and raw materials used in their manufacture and packaging, to prevent loss and diversion into illicit channels of commerce.

DEA regulates controlled substances as Schedule I, II, III, IV or V substances. Schedule I substances by definition have no currently accepted medicinal use, a high potential for abuse, and may not be marketed or sold in the United States. A pharmaceutical product may be listed as Schedule II, III, IV or V, with Schedule II substances considered to present the highest risk of abuse and Schedule V substances the lowest relative risk of abuse among such substances.

Annual registration is required for any facility that manufactures, distributes, dispenses, imports or exports any controlled substance. The registration is specific to the particular facility, the activities conducted at the facilities, and relevant controlled substance

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schedules. For example, separate registrations are required for a facility that both imports and manufactures a controlled substance, and each registration will specify which schedules of controlled substances are authorized.

DEA may inspect a facility to review its security measures prior to issuing a registration and may also conduct periodic inspections of registered establishments that handle controlled substances. Security requirements vary by controlled substance schedule, with the most stringent requirements applying to Schedule I and Schedule II substances. Records must be maintained for the handling of all controlled substances, and periodic reports made to DEA, for example distribution reports for Schedule I and II controlled substances, Schedule III substances that are narcotics, and other designated substances. Reports must also be made for thefts or losses of any controlled substance, and to obtain authorization to destroy any controlled substance. Authorization and notification requirements also apply to imports and exports.

A DEA quota system controls and limits the availability and production of controlled substances in Schedules I and II. Distributions of any Schedule I or II controlled substance must also be accompanied by order forms, with copies provided to DEA. DEA may adjust aggregate production quotas and individual production and procurement quotas from time to time during the year, although DEA has substantial discretion in whether or not to make such adjustments.

Individual states also regulate controlled substances.

U.S. Review and Approval Process for Drugs

Assuming successful completion of the required clinical testing, the results of the preclinical studies and clinical trials, together with detailed information relating to the product’s chemistry, manufacture, controls and proposed labeling, and other relevant information are submitted to the FDA as part of an NDA requesting approval to market the product for one or more indications. Data may come from company-sponsored clinical trials intended to test the safety and efficacy of a product’s use or from a number of alternative sources, including studies initiated by investigators. To support marketing approval, the data submitted must be sufficient in quality and quantity to establish the safety and efficacy of the investigational product to the satisfaction of the FDA. FDA approval of an NDA must be obtained before a drug may be marketed in the United States. Submitting an NDA requires payment of substantial user fees. The FDA adjusts the Prescription Drug User Fee Act (“PDUFA”) user fees on an annual basis. Fee waivers or reductions are available in certain circumstances, including a waiver of the application fee for the first application filed by a small business. Additionally, the FDA does not assess user fees on NDAs for products designated as orphan drugs unless the product also includes a non-orphan indication.

The FDA reviews an NDA to determine, among other things, whether the drug is safe and effective for its intended use and whether its manufacturing is cGMP-compliant to assure the product’s continued safety, quality and purity. Under the goals and polices agreed to by the FDA under the PDUFA, the FDA has a goal of ten months from the date of “filing” of a standard NDA for a new molecular entity to review and act on the submission (and a goal of six months for a priority review). This review typically takes twelve months for a standard NDA and eight months for a priority NDA from the date the NDA is submitted to FDA because the FDA has approximately two months to make a “filing” decision after the application is submitted. Specifically, the FDA conducts a preliminary review of all submitted NDAs within 60 days of receipt to determine whether they are sufficiently complete to permit substantive review. The FDA may request additional information instead of accepting an NDA for filing. In this event, the NDA must be resubmitted with the additional information. The FDA must also review the resubmitted application before it accepts it for filing. The FDA does not always meet its PDUFA goal dates for standard or priority NDAs, and the review process is often extended by FDA requests for additional information or clarification.

The FDA may refer an application for a novel drug to an advisory committee. An advisory committee is a panel of independent experts, including clinicians and other scientific experts, which reviews, evaluates and provides a recommendation as to whether the application should be approved and under what conditions. The FDA is not bound by an advisory committee's recommendations, but it considers such recommendations carefully when making decisions.

Before approving an NDA, the FDA typically will inspect the facility or facilities where the product is manufactured. The FDA will not approve an application unless it determines that the manufacturing processes and facilities comply with cGMP requirements and are adequate to assure consistent production of the product within required specifications. Additionally, before approving an NDA, the FDA may inspect one or more clinical trial sites to assure compliance with GCP and other requirements and the integrity of the clinical data submitted to the FDA.

If the FDA determines the application, manufacturing process or manufacturing facilities are not acceptable, it will outline the deficiencies in the submission and often will request additional testing or information. Notwithstanding the submission of any requested additional information, the FDA ultimately may decide that the application does not satisfy the regulatory criteria for approval.

After the FDA evaluates an NDA, it may issue an approval letter or a complete response letter. An approval letter authorizes commercial marketing of the drug with specific prescribing information for specific indications. A complete response letter indicates that the review cycle is complete, and the application will not be approved in its present form. A complete response letter generally

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describes the specific deficiencies in the NDA identified by the FDA and may require additional clinical data, such as an additional pivotal Phase 3 trial or other significant and time-consuming requirements related to clinical trials, nonclinical studies or manufacturing. If the FDA issues a Complete Response Letter, the sponsor must resubmit the NDA, addressing all of the deficiencies identified in the letter, or withdraw the application. Even if such data and information are submitted, the FDA may decide that the NDA does not satisfy the criteria for approval.

If the FDA grants regulatory approval of a product, it will be granted for particular indications and may include limitations on the indicated uses for which the product may be marketed. For example, the FDA may approve the NDA with a Risk Evaluation and Mitigation Strategy (“REMS”) to ensure that the benefits of the drug outweigh its risks. A REMS is a safety strategy to manage a known or potential serious risk associated with a medicine and to enable patients to have continued access to such medicines by managing their safe use, and could include medication guides, physician communication plans, assessment plans and/or elements to assure safe use, such as restricted distribution methods, patient registries or other risk-minimization tools. The FDA also may condition approval on, among other things, changes to proposed labeling or the development of adequate controls and specifications. Once approved, the FDA may withdraw approval if the company does not maintain compliance with pre- and post-marketing requirements is not maintained or if problems occur after the product reaches the marketplace. The FDA may also require one or more post-approval studies and surveillance, including Phase 4 clinical trials, be conducted to further assess and monitor the product’s safety and effectiveness after marketing, and may prevent or limit further marketing of a product based on the results of post-marketing studies or surveillance programs. After approval, some types of changes to the approved product, such as adding new indications, manufacturing changes and additional labeling claims, are subject to further testing requirements and FDA review and approval. In addition, new government requirements, including those resulting from new legislation, may be established, or the FDA’s policies may change, which could impact the timeline for regulatory approval or otherwise impact ongoing development programs.

Expedited Development and Review Programs for Drugs

The FDA has a number of programs intended to expedite the development or review of products that meet certain criteria.

For example, new drugs are eligible for Fast Track designation if they are intended to treat a serious or life-threatening disease or condition and demonstrate the potential to address unmet medical needs for such disease or condition. Fast Track designation applies to the combination of the product and the specific indication for which it is being studied. The sponsor of a Fast Track designated product has opportunities for more frequent sponsor interactions with the FDA review team during preclinical and clinical development, in addition to the potential for rolling review once a marketing application is filed, meaning that the agency may review portions of the marketing application before the sponsor submits the complete application, if the sponsor provides a schedule for the submission of the sections of the NDA, the FDA agrees to accept sections of the NDA and determines that the schedule is acceptable, and the sponsor pays any required user fees upon submission of the first section of the NDA. In addition, a sponsor may seek FDA designation of a product candidate as a “breakthrough therapy” if the product candidate is intended, alone or in combination with one or more other products, to treat a serious or life-threatening disease or condition and preliminary clinical evidence indicates that the drug may demonstrate substantial improvement over existing therapies on one or more clinically significant endpoints, such as substantial treatment effects observed early in clinical development. Breakthrough Therapy designation includes all the features of Fast Track designation, plus more intensive FDA interaction and guidance. If a product is designated as Breakthrough Therapy, the FDA will work to expedite the development and review of such drug through FDA organizational commitment to expedited development, including involvement of senior managers and experienced review staff in a cross-disciplinary review, where appropriate.

Any product submitted to the FDA for approval, including a product with Fast Track or Breakthrough Therapy designation, may also be eligible for other types of FDA programs intended to expedite development and review, including Priority Review designation and Accelerated Approval. A product is eligible for Priority Review if it has the potential to provide a significant improvement in safety or effectiveness in the treatment, diagnosis or prevention of a serious disease or condition. Under Priority Review, the FDA aims to review an application within six months of filing, compared with ten months for a standard review.

Additionally, products may be eligible for Accelerated Approval if they are intended to treat serious or life-threatening diseases or conditions and are determined to have an effect on a surrogate endpoint that is reasonably likely to predict clinical benefit, or an effect on a clinical endpoint that can be measured earlier than an effect on irreversible morbidity or mortality which is reasonably likely to predict an effect on irreversible morbidity or mortality or other clinical benefit, taking into account the severity, rarity or prevalence of the condition and the availability or lack of alternative treatments. As a condition of approval, the FDA may require that a sponsor of a drug receiving Accelerated Approval conduct additional post-approval studies to verify and describe the product’s clinical benefit. The FDA may withdraw approval of a drug or indication approved under Accelerated Approval if, for example, the confirmatory trial fails to verify the predicted clinical benefit of the product. In addition, for products reviewed under Accelerated Approval, unless otherwise informed by the FDA, the FDA requires that all advertising and promotional materials that are intended for dissemination or publication within 120 days following marketing approval be submitted to the agency for review during the pre-approval review period, and that after 120 days following marketing approval, all advertising and promotional materials must be submitted at least 30 days prior to the intended time of initial dissemination or publication.

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Even if a product qualifies for one or more of these programs, the FDA may later decide that the product no longer meets the conditions for qualification or the time period for FDA review or approval may not be shortened. Furthermore, Fast Track designation, Breakthrough Therapy designation, Priority Review and Accelerated Approval do not change the standards for approval but may expedite the development or review process. No Neuphoria-sponsored development program is active. These pathways could become relevant if a program is resumed by Neuphoria or a future licensee.

Pediatric Information and Pediatric Exclusivity

Under the Pediatric Research Equity Act (“PREA”), as amended, certain NDAs and certain supplements to an NDA must contain data to assess the safety and efficacy of the drug for the claimed indications in all relevant pediatric subpopulations and to support dosing and administration for each pediatric subpopulation for which the product is safe and effective. The FDA may grant deferrals for submission of pediatric data or full or partial waivers. The FD&C Act requires that a sponsor who is planning to submit a marketing application for a drug that includes a new active ingredient, new indication, new dosage form, new dosing regimen or new route of administration submit an initial Pediatric Study Plan (“PSP”), within 60 days of an End-of-Phase 2 meeting or, if there is no such meeting, as early as practicable before the initiation of the Phase 3 or Phase 2/3 trial. The FDA and the sponsor must reach an agreement on the PSP. A sponsor can submit amendments to an agreed-upon initial PSP at any time if changes to the pediatric plan need to be considered based on data collected from preclinical studies, early-phase clinical trials and/or other clinical development programs.

A drug can also obtain pediatric market exclusivity in the U.S. Pediatric exclusivity, if granted, adds six months to existing exclusivity periods and patent terms. This six-month exclusivity, which runs from the end of other exclusivity protection or patent term, may be granted based on the voluntary completion of a pediatric trial or of multiple pediatric trials in accordance with an FDA-issued “Written Request” for such trials.

U.S. Post-Approval Requirements for Drugs

Drugs manufactured or distributed pursuant to FDA approvals are subject to pervasive and continuing regulation by the FDA, including, among other things, requirements relating to recordkeeping, periodic reporting, product sampling and distribution, reporting of adverse experiences with the product, complying with promotion and advertising requirements, which include restrictions on promoting products for unapproved uses or patient populations (known as “off-label use”) and limitations on industry-sponsored scientific and educational activities. After approval, most changes to the approved product, such as adding new indications or other labeling claims, are subject to prior FDA review and approval. There also are continuing, annual program fees for any marketed products.

In addition, drug manufacturers and their subcontractors involved in the manufacture and distribution of approved drugs are required to register their establishments with the FDA and certain state agencies and are subject to periodic unannounced inspections by the FDA and certain state agencies for compliance with ongoing regulatory requirements, including cGMP, which impose certain procedural and documentation requirements upon us and our contract manufacturers. Changes to the manufacturing process are strictly regulated and, depending on the significance of the change, may require prior FDA approval before implementation. FDA regulations also require investigation and correction of any deviations from cGMP and impose reporting requirements upon us and any third-party manufacturers that we may decide to use. Accordingly, manufacturers must continue to expend time, money, and effort in production and quality control to maintain compliance with cGMP and other regulatory requirements. Failure to comply with statutory and regulatory requirements can subject a manufacturer to possible legal or regulatory action, such as warning letters, suspension of manufacturing, product seizures, injunctions, civil penalties or criminal prosecution.

The FDA may withdraw approval if compliance with regulatory requirements and standards is not maintained or if problems occur after the product reaches the market. Later discovery of previously unknown problems with a product, including adverse events of unanticipated severity or frequency, or with manufacturing processes, or failure to comply with regulatory requirements, may result in revisions to the approved labeling to add new safety information, requirements for post-market studies or clinical trials to assess new safety risks, or imposition of distribution or other restrictions under a REMS. Other potential consequences include, among other things:

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restrictions on the marketing or manufacturing of the product, complete withdrawal of the product from the market or product recalls;

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the issuance of safety alerts, Dear Healthcare Provider letters, press releases or other communications containing warnings or other safety information about the product;

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fines, warning letters or untitled letters or holds on post-approval clinical trials;

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refusal of the FDA to approve applications or supplements to approved applications, or suspension or withdrawal of product approvals;

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product seizure or detention, or refusal to permit the import or export of products;

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consent decrees, corporate integrity agreements, debarment or exclusion from federal healthcare programs;

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mandated modification of promotional materials and labeling and issuance of corrective information; and

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injunctions or the imposition of civil or criminal penalties.

The FDA may also require post-market testing, including Phase 4 clinical trials, and surveillance to further assess and monitor the product’s safety and effectiveness after commercialization. The FDA closely regulates the marketing, labeling, advertising and promotion of drug products. A company can make only those claims relating to safety and efficacy that are approved by the FDA and in accordance with the provisions of the approved label. The FDA and other agencies actively enforce the laws and regulations prohibiting the promotion of off-label uses. Failure to comply with these requirements can result in, among other things, adverse publicity, warning letters, corrective advertising and potential civil and criminal penalties. Physicians may prescribe, in their independent professional medical judgment, legally available products for uses that are not described in the product’s labeling and that differ from those tested by us and approved by the FDA. Physicians may believe that such off-label uses are the best treatment for many patients in varied circumstances. The FDA does not regulate the behavior of physicians in their choice of treatments. The FDA does, however, restrict manufacturer’s communications on the subject of off-label use of their products. The federal government has levied large civil and criminal fines against companies for alleged improper promotion of off-label use and has enjoined companies from engaging in off-label promotion. The FDA and other regulatory agencies have also required that companies enter into consent decrees or permanent injunctions under which specified promotional conduct is changed or curtailed. However, companies may share truthful, non-misleading information that is otherwise consistent with a product’s FDA-approved labeling. In addition, the distribution of prescription pharmaceutical products is subject to the Prescription Drug Marketing Act (“PDMA”) which regulates the distribution of drugs and drug samples at the federal level and sets minimum standards for the registration and regulation of drug distributors by the states. Both the PDMA and state laws limit the distribution of prescription pharmaceutical product samples and impose requirements to ensure accountability.

Marketing Exclusivity

Market exclusivity provisions under the FD&C Act can delay the submission or the approval of certain marketing applications. The FD&C Act provides a five-year period of non-patent exclusivity within the United States to the first applicant to obtain approval of an NDA for a new chemical entity. A drug is a new chemical entity if the FDA has not previously approved any other new drug containing the same active moiety, which is the molecule or ion responsible for the action of the drug substance. During the exclusivity period, the FDA may not approve or even accept for review an abbreviated new drug application (“ANDA”), or an NDA submitted under Section 505(b)(2), or 505(b)(2) NDA, submitted by another company for another drug based on the same active moiety, regardless of whether the drug is intended for the same indication as the original innovative drug or for another indication. However, such an application may be submitted after four years if it contains a certification of patent invalidity or non-infringement to one of the patents listed with the FDA by the innovator NDA holder. The FD&C Act alternatively provides three years of marketing exclusivity for an NDA, or supplement to an existing NDA, if new clinical investigations, other than bioavailability studies, that were conducted or sponsored by the applicant are deemed by the FDA to be essential to the approval of the application, for example new indications, dosages or strengths of an existing drug. This three-year exclusivity covers only the modification for which the drug received approval on the basis of the new clinical investigations and does not prohibit the FDA from approving ANDAs or 505(b)(2) NDAs for drugs containing the active agent for the original indication or condition of use. Five-year and three-year exclusivity will not delay the submission or approval of a full NDA. However, an applicant submitting a full NDA would be required to conduct or obtain a right of reference to any preclinical studies and adequate and well-controlled clinical trials necessary to demonstrate safety and effectiveness.

Other Regulatory Matters

Manufacturing, sales, promotion and other activities of product candidates following product approval, where applicable, or commercialization are also subject to regulation by numerous regulatory authorities in the United States in addition to the FDA, which may include the Centers for Medicare & Medicaid Services other divisions of the HHS, the Department of Justice, the DEA, the Consumer Product Safety Commission, the Federal Trade Commission (“FTC”), the Occupational Safety & Health Administration, the Environmental Protection Agency and state and local governments and governmental agencies.

Other Healthcare Laws

Pharmaceutical companies are subject to additional healthcare regulation and enforcement by the federal government and by authorities in the states and foreign jurisdictions in which they conduct business, which may constrain the financial arrangements and relationships through which we research, sell, market, and distribute any products for which we obtain marketing approval. Such laws include, without limitation, federal and state anti-kickback, fraud and abuse, false claims, and transparency laws and regulations with respect to drug pricing and payments and other transfers of value made to physicians and other health care providers. Violations of

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any of such laws or any other governmental regulations that apply may result in significant penalties, including, without limitation, administrative, civil and criminal penalties, damages, fines, disgorgement, the curtailment or restructuring of operations, integrity oversight and reporting obligations to resolve allegations of noncompliance, exclusion from participation in federal and state healthcare programs and imprisonment for any responsible individuals.

Coverage and Reimbursement

Our ability to successfully commercialize any pharmaceutical product candidate depends, in part, on (1) the extent to which the product will be covered by third-party payors, such as federal, state, and foreign government healthcare programs, commercial insurance and managed healthcare organizations, and (2) the level of reimbursement for such product by third-party payors. Decisions regarding the extent of coverage and amount of reimbursement to be provided are made on a plan-by-plan basis. Even if coverage is provided, the approved reimbursement amount may not be high enough to allow us to establish or maintain pricing sufficient to realize a sufficient return on our investment.

Third-party payors are increasingly reducing coverage and reimbursement for medical products, drugs and services. Significant uncertainty remains regarding insurance coverage and reimbursement for newly approved products, and coverage may be more limited than the purposes for which the medicine is approved by the FDA or comparable foreign regulatory authorities. In the United States, no uniform policy of coverage and reimbursement for drug products exists among third-party payors. Third-party payors often rely on Medicare coverage policy and payment limitations when setting their own reimbursement rates, but they also use their own methods and approval processes separate from Medicare determinations. Therefore, coverage and reimbursement for drug products can differ significantly from payor to payor. As a result, the coverage determination process is often time-consuming and costly and requires us to provide scientific and clinical support for the use of our product candidates to each payor separately, with no assurance that coverage and adequate reimbursement will be obtained. In addition, the U.S. government, state legislatures and foreign governments have continued implementing cost-containment programs, including price controls, restrictions on coverage and reimbursement and requirements for substitution of generic products. Adoption of price controls and cost-containment measures, adoption of more restrictive policies in jurisdictions with existing controls and measures, could further limit sales of any product. We cannot be sure that reimbursement will be available for any product candidate that we commercialize and, if reimbursement is available, the level of reimbursement. Decreases in third-party reimbursement for any product or a decision by a third-party payor not to cover a product could reduce physician usage and patient demand for the product and also have a material adverse effect on sales.

Healthcare Reform

In the United States, in 2010, the Patient Protection and Affordable Care Act, as amended by the Health Care and Education Reconciliation Act, as amended, collectively known as the ACA, was enacted, which substantially changed the way healthcare is financed by both governmental and private insurers, and significantly affected the pharmaceutical industry. The ACA contained a number of provisions, including those governing enrollment in federal healthcare programs, reimbursement adjustments and changes to fraud and abuse laws. For example, the ACA:

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increased the minimum level of Medicaid rebates payable by manufacturers of brand-name drugs from 15.1% to 23.1% of the average manufacturer price;

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required collection of rebates for drugs paid by Medicaid managed care organizations;

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required manufacturers to participate in a coverage gap discount program, under which they must agree to offer 50% (increased to 70% pursuant to the Bipartisan Budget Act of 2018, effective as of January 1, 2019) point-of-sale discounts off negotiated prices of applicable brand drugs to eligible beneficiaries during their coverage gap period, as a condition for the manufacturer’s outpatient drugs to be covered under Medicare Part D; and

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imposed a non-deductible annual fee on pharmaceutical manufacturers or importers who sell “branded prescription drugs” to specified federal government programs.

Other legislative changes have been proposed and adopted since the ACA was enacted. For example, on March 11, 2021, President Biden signed the American Rescue Plan Act of 2021 into law, which eliminates the statutory Medicaid drug rebate cap, currently set at 100% of a drug’s average manufacturer price, for single-source and innovator multiple-source drugs, beginning January 2024. Further, in August 2011, the Budget Control Act of 2011, among other things, included aggregate reductions of Medicare payments to providers of 2% per fiscal year. These reductions went into effect in April 2013 and, due to subsequent legislative amendments to the statute, will remain in effect through 2030.

Further, on May 30, 2018, the Right to Try Act was signed into law. The law, among other things, provides a federal framework for certain patients to access certain investigational new drug products that have completed a Phase 1 clinical trial and that are undergoing investigation for FDA approval. Under certain circumstances, eligible patients can seek treatment without enrolling in clinical trials and without obtaining FDA permission under the FDA expanded access program. There is no obligation for a pharmaceutical manufacturer to make its drug products available to eligible patients as a result of the Right to Try Act.

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On August 16, 2022, the Inflation Reduction Act of 2022 ("IRA") was signed into law, which marks the most significant action by Congress with respect to the pharmaceutical industry since adoption of the ACA in 2010. Among other things, the IRA requires manufacturers of certain drugs to engage in price negotiations with Medicare (beginning in 2026), imposes rebates under Medicare Part B and Medicare Part D to penalize price increases that outpace inflation (began in 2023), and replaces the Part D coverage gap discount program with a new discounting program (beginning in 2025). The IRA permits the Secretary of the Department of Health and Human Services ("HHS") to implement many of these provisions through guidance, rather than regulation, in the initial years. For that and other reasons, it is currently unclear how the IRA will be effectuated, and while the impact of the IRA on the pharmaceutical industry cannot yet be fully determined, it is likely to be significant.

On July 4, 2025, the One Big Beautiful Bill Act was signed into law. Among other provisions, it restored businesses' ability to immediately deduct qualifying domestic research and experimental expenditures and modified the treatment of certain orphan drugs under the Medicare drug-price negotiation provisions of the Inflation Reduction Act. The ultimate effect of these provisions on us or any future commercialization partner will depend on implementing guidance and our facts and circumstances.

Moreover, there has recently been heightened governmental scrutiny over the manner in which manufacturers set prices for their marketed products, which has already resulted in several Congressional inquiries, proposed and enacted legislation and executive orders designed to, among other things, bring more transparency to product pricing, review the relationship between pricing and manufacturer patient programs, and reform government program reimbursement methodologies for drug products. More recently, this has led the Federal Trade Commission and the Department of Justice to investigate whether some pricing algorithms facilitate illegal price-fixing by relying on competitor pricing data. Individual states in the United States have also become increasingly active in implementing regulations designed to control pharmaceutical product pricing, including price or patient reimbursement constraints, discounts, restrictions on certain product access and marketing cost disclosure and transparency measures, and, in some cases, designed to encourage importation from other countries and bulk purchasing.

We expect additional state and federal healthcare reform measures to be adopted in the future, any of which could affect the amounts that federal and state governments and other third-party payors pay for healthcare products and services.

Data Privacy and Security Laws

Numerous state, federal and foreign laws, including consumer protection laws and regulations, govern the collection, dissemination, use, access to, confidentiality, and security of personal information, including health-related information. In the United States, numerous federal and state laws and regulations, including data breach notification laws, health information privacy and security laws, including Health Insurance Portability and Accountability Act (“HIPAA”) and federal and state consumer protection laws and regulations (e.g., Section 5 of the Federal Trade Commission Act) that govern the collection, use, disclosure, and protection of health-related and other personal information could apply to our operations or the operations of our partners. In addition, certain state and non-U.S. laws, such as the California Consumer Privacy Act (“CCPA”), the California Privacy Rights Act (“CPRA”), Australia’s Privacy Act 1988, as amended, and the General Data Protection Regulation (“GDPR”) govern the privacy and security of personal information, including health-related information in certain circumstances, some of which are more stringent than HIPAA and many of which differ from each other in significant ways and may not have the same effect, thus complicating compliance efforts. Failure to comply with these laws, where applicable, can result in the imposition of significant civil and/or criminal penalties and private litigation. Privacy and security laws, regulations, and other obligations are constantly evolving, may conflict with each other to make compliance efforts more challenging, and can result in investigations, proceedings, or actions that lead to significant penalties and restrictions on data processing.

Employees

As part of the restructuring initiated in October 2025, we terminated all but one full-time employee and our facility leases. We currently operate with a limited workforce and rely on consultants and external service providers for executive, financial, legal, compliance and other functions. Our employee is not represented by a collective bargaining agreement.

Our current human-capital priority is to retain the personnel and external resources needed to complete the Merger, satisfy our obligations as a public company and administer our remaining contractual and intellectual-property rights.

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