What changed in this filing

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Item 2. Management’s Discussion and Analysis

2026-02-06 compared with 2025-11-10 · 86 added, 43 removed, 196 unchanged (40% of the section changed)

91 unchanged sentences

Program of the Congressionally Directed Medical Research Programs.

In August 2024, the FD&A and the U.S.

In August 2024, the FDA and the U.S.

Army Medical Research and

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and India to date.

Alzheimer’s Disease (NCT05083260)

Alzheimer’s Disease

On November 29, 2023, the Company announced the

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be collected and analyzed.

Comparison of the three months ended September 30, 2025 to the three

months ended September 30, 2024

The net loss for the three months ended September

30, 2025 was approximately $5.1 million and as compared to the net loss of $4.2 million for the three months ended September 30, 2024.

The net increase of $900,000 for the three months ended September 30, 2025 was comprised of the net increase in research and development

expenses of $946,000, net increase in general and administrative expenses of approximately $216,000 offset by a decrease in other (income)

expense, net of approximately $227,000.

Total operating expenses for the three months

ended September 30, 2025 were approximately $5.3 million as compared to $4.1 million for the three months ended September 30, 2024.

net increase of approximately $1.2 million for the three months ended September 30, 2025, was comprised of net increased research and

development expenses of approximately $946,000 primarily attributed to the development and launch of both the Long COVID program in April

2025 and Sunrise PD Phase 2 studies in May 2025 and the net increase in general and administrative expenses of approximately $216,000.

Comparison of the three months ended December 31, 2025 to the three

months ended December 31, 2024

The net loss for the three months ended

December 31, 2025 was approximately $6.1 million as compared to the net loss of approximately $7.1 million for the three months

ended December 31, 2024.

The net decrease of $1.0 million for the three months ended December 31, 2025 was comprised of a net

decrease in research and development ("R&D") expenses of approximately $435,000, and a net decrease in general and

administrative expenses of approximately $595,000.

Total operating expenses for the three

months ended December 31, 2025 were approximately $6.3 million as compared to $7.3 million for the three months ended December 31,

The net decrease of approximately $1.0 million for the three months ended December 31, 2025, was comprised of a net

decrease in R&D expenses of approximately $435,000 and a net decrease in general and administrative expenses of approximately

Research and Development Expenses

Research and development (“R&D”)

expenses were approximately $2.9 million for the three months ended September 30, 2025, an increase of approximately $946,000 from $2.0

million for three months ended September 30, 2024.

The net increase in R&D expenses of approximately $946,000 is comprised of increased

direct study costs of approximately $1.2 million for the Parkinson Disease (PD) and Long COVID (“LC”) studies and clinical

team stock compensation of approximately $270,000, travel and conferences of approximately $49,000, offset by CMC of approximately $407,000,

clinical team payroll of approximately $87,000 and other clinical consultants of approximately $57,000.

The increase in clinical studies of approximately

$1.2 million represented planning, development and launch of the two new clinical studies, Sunrise PD Phase 2 and Long Covid Program.

The table below summarizes the expense amounts for the three months ended September 30, 2025 and 2024 by study:

expenses were approximately $4.3 million and $4.7 million for the three months ended December 31, 2025 and 2024, respectively.

decrease of approximately $435,000 was primarily attributed to the Long COVID (“LC”) studies’ decline in net expenses

due to the large start-up contractual payments made to the Contract Research Organizations (“CRO”) and no reimbursements received

during the three months ended December 31, 2024;

offset by increased cost from the Sunrise PD Phase 2 study, from the increased activities

in the Sunrise PD Phase 2 study became fully enrolled.

The table below indicates the cost incurred by study program.

Three months ended

September 30, 2025

September 30, 2024

Current Studies

December 31, 2025

December 31, 2024

Sunrise PD Phase 2

Liver Program Phase 3

Long COVID Program, net of $336,000 and $325,000 reimbursement, respectively

Long COVID Phase 2

Long COVID Phase 2 - reimbursements

General and Administrative Expenses

General and administrative expenses were approximately

$2.3 million and $2.1 million for the three months ended September 30, 2025 and 2024, respectively.

The net increase of approximately

$216,000 was primarily attributed to increases in legal fee expenses of approximately $215,000, investor and public relation fees of approximately

$124,000, filing fees of approximately $35,000 and insurance premiums of approximately $14,000;

offset by decreases in stock-based compensation

for the executive team and directors of approximately $83,000 and $93,000, respectively.

General and administrative expenses were approximately $1.9 million

and $2.5 million for the three months ended December 31, 2025 and 2024, respectively.

The net decrease of approximately $595,000 was primarily

attributed to decreases in stock-based compensation for the executive team and directors of approximately $154,000 and $58,000, respectively,

consultancy fees of approximately $593,000, investor and public relation fees of approximately $30,000, filing fees of approximately $41,000,

offset by increased legal fees related to the class action litigation of approximately $331,000, and insurance premiums of approximately

Other Income and Expense

Other income, net was approximately $193,000

compared to other income, net of approximately $180,000, for the three months ended December 31, 2025 and 2024, respectively.

increase in other income of approximately $13,000 was primarily comprised of a reduction in interest expense of approximately $61,000

due to the payoff of the notes payable on December 1, 2024, offset by a reduction in interest income of approximately $54,000.

Comparison of the six months ended December 31, 2025 to the six

months ended December 31, 2024

The net loss for the six months ended December

31, 2025 was approximately $11.2 million comparable to the net loss of approximately $11.3 million for the six months ended December 31,

The net decrease of approximately $108,000 for the six months ended December 31, 2025 was comprised of the net increase in operating

expenses of approximately $132,000 offset by the increase in other income, net of approximately $240,000.

Total operating expenses for the six months

ended December 31, 2025 were approximately $11.5 million as compared to $11.4 million for the six months ended December 31,

The net R&D increase of approximately $132,000 for the six months ended December 31, 2025, was comprised of net

increased research and development expenses of approximately $511,000 primarily attributed to the development and launch of both the

Long COVID program in April 2025 and Sunrise PD Phase 2 studies in May 2025 offset by the decline in general and administrative

expenses of approximately $379,000.

Research and Development Expenses

R&D expenses were approximately

$7.2 million for the six months ended December 31, 2025, an increase of approximately $511,000 from $6.7 million for six months ended

December 31, 2024.

The net increase in R&D expenses of approximately $511,000 is comprised of increased direct study costs of approximately

$818,000, clinical team compensation of approximately $88,000, travel and conferences of approximately $153,000, offset by approximately

$541,000 of Chemistry, Manufacturing and Controls (“CMC”) expenses that have been temporarily curtailed.

As the table indicates below, the increase in

clinical studies of approximately $818,000 were comprised of the increased Sunrise PD Phase 2 study cost of approximately $2.3 million

and the decline in Long Covid Phase 2 study cost of net of reimbursements totaling approximately $1.5 million that consisted of the large

contractual start-up fee paid the CRO and the lag in receiving the reimbursements during the six months ended December 31, 2024.

Six months ended

December 31, 2025

December 31, 2024

Sunrise PD Phase 2

Liver Program Phase 3

Long COVID Phase 2

Long COVID Phase 2 - reimbursements

General and Administrative Expenses

General and administrative expenses were approximately $4.2 million

and $4.6 million for the six months ended December 31, 2025 and 2024, respectively.

The net decrease of approximately $379,000 was primarily

attributed to decreases in stock-based compensation for the executive team and directors of approximately $238,000 and $151,000, respectively

and consultancy fees of approximately $565,000;

offset by a net increase in legal fee expenses of approximately $546,000 that primarily

represented legal fees related to the class action litigation.

Other Income and Expense

Other income, net was approximately $390,000 compared

to other expenses, net of $30,000, for the three months ended September 30, 2025 and 2024, respectively.

to other income, net of $150,000, for the six months ended December 31, 2025 and 2024, respectively.

The net increase in other income

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Capital Resources and Liquidity

As of September 30, 2025, the Company had working

capital of approximately $24.4 million, cash and cash equivalents totaling approximately $25.0 million, stockholders’ equity of

approximately $24.9 million, and an accumulated deficit of approximately $357.3 million.

As of December 31, 2025, the Company had working capital of approximately

$18.8 million, cash and cash equivalents totaling approximately $20.5 million, stockholders’ equity of approximately $19.3 million,

and an accumulated deficit of approximately $363.3 million.

The Company used net cash in operations totaling

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to purchase one share of common stock at an exercise price of $2.50 per share and expires five years from the date of issuance.

Each Pre-Funded

Warrant is immediately exercisable, entitles the holder to purchase one share of common stock and may be exercised at any time until exercised

Each Pre-Funded Warrant is immediately exercisable, entitles the holder to purchase

one share of common stock and may be exercised at any time until exercised in full.

Additionally, upon closing, the Company issued the

underwriter warrants to purchase 300,000 shares of Common Stock exercisable at a per share price of $2.50, which was equal to 125% of

the public offering price per share.

The underwriter's Warrants are exercisable during a five-year period commencing 180 days from August

Critical Accounting Policies and Estimates

There were no significant changes to the Company’s

critical accounting policies as identified in the Annual Report Form 10-K for the fiscal year ended June 30, 2025 (the “2025 Form

There were no significant changes to the Company's critical accounting policies as identified in the Annual Report Form 10-K for the fiscal year ended June 30, 2025 (the "2025 Form 10-K").

New Accounting Pronouncements

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Compared sentence by sentence after normalising whitespace, quotation marks, case and digits, so re-formatting and restated figures do not read as changed language. Wording changes appear as one removal and one addition. The current filing and the prior one are authoritative.

What changed 10-Q

Item 2. Management’s Discussion and Analysis