What changed in this filing

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Item 1A. Risk Factors

2025-03-26 compared with 2024-02-23 · 44 added, 69 removed, 2044 unchanged (5% of the section changed)

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and refining our technology, and since 2019, we have focused our efforts on advancing the development of our product candidate, HSB-1216,

which we recently deprioritized, as well as TH3215, TH0059 and TH1940 (formerly known as HSB-3215, HSB-0059 and HSB-1940, respectively).

which we recently deprioritized, as well as HS3215, HS0059 and HS1940.

In November 2023, we entered into the Avior Patent License Agreement for a clinical-stage asset, TH104, and TH103, a compound which we

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longer operating history.

intend to commence Phase 1 clinical studies for TH104 in 2023 and Phase 2 clinical studies in 2024.

plan to initiate a hepatic impairment study in 2025 prior to starting the Phase 2 clinical trial in TH104.

In addition, we intend to submit

INDs to the FDA for our early-stage pre-clinical programs to gain approval to initiate clinical studies in 2025 for both TH3215 and TH1940;

however, no assurance can be provided that our clinical Phase 1 or Phase 2 studies will be completed or that our INDs will be accepted

INDs to the FDA for our early-stage pre-clinical programs to gain approval to initiate clinical studies in 2025 for both HS3215 and HS1940;

however, no assurance can be provided that our Phase 2 trial will be completed or that our INDs will be accepted

by the FDA based on our anticipated timeline, if at all.

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curtail, delay or discontinue our research or drug development programs or any future commercialization efforts.

intend to advance TH104, a clinical stage asset, as well as our early-stage candidates, TH3215, TH0059 and TH1940, through development.

intend to advance TH104, a clinical stage asset, as well as our early-stage candidates, HS3215, HS0059 and HS1940, through development.

Developing drugs is expensive and we expect our research and development expenses to increase substantially in connection with our ongoing

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Our financial statements as of December 31, 2024 did not include any adjustments that might result from the outcome of this uncertainty.

The reaction of investors to the inclusion of a going concern statement in the accompanying financial statement, and our potential inability

The reaction of investors to the inclusion of a goingconcern statement in the accompanying financial statement, and our potential inability

to continue as a going concern, in future years could materially adversely affect our share price and our ability to raise new capital

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addition, we will need to initiate clinical trials for TH104.

In addition, we will need to receive FDA clearance of our IND for TH3215,

TH0059 and TH1940 before we can begin clinical trials and would require the same acceptance by the FDA prior to initiating any clinical

In addition, we will need to receive FDA clearance of our IND for HS3215, HS0059 and HS1940 before we can begin clinical trials and would require the same acceptance by the FDA prior to initiating any clinical

trials in the United States for any of our other drug candidates.

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time to time, we may publicly disclose preliminary, interim or topline data from our clinical trials, such as the interim data from clinical

trials related to TH104, or preclinical data for TH3215, TH0059 or TH1940.

trials related to TH104, or preclinical data for HS3215, HS0059 or HS1940.

These interim updates are based on a preliminary analysis

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little, if any, value, which would have a material and adverse effect on our business, financial condition, results of operations and

TH3215, TH0059 and TH1940 are novel product candidates, making it difficult to predict the time, cost and potential success of these

HS3215, HS0059 and HS1940 are novel product candidates, making it difficult to predict the time, cost and potential success of these

product candidates.

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COVID-19 pandemic and efforts to control its spread had an impact on our operations.

example, as a result of COVID-19, we previously experienced delays from our manufacturers with respect to the shipping of our materials

as well as delays in completion of analytical testing as a result of the shelter-in-place order restrictions.

Pandemics, such as COVID-19,

may have a material economic effect on our business because our research and development may be affected as a result of delays in study

monitoring and data analysis;

some participants and clinical investigators may not be able to comply with clinical trial protocols;

quarantines or other travel limitations (whether voluntary or required) may impede participant movement, affect sponsor access to study

sites, or interrupt healthcare services, resulting in our inability to conduct our research activities, including our clinical trials;

and infections and deaths related to a pandemic may disrupt the United States’ healthcare and healthcare regulatory systems which

could divert healthcare resources away from, or materially delay FDA review and/or approval of our product candidates.

While the potential

economic impact brought by such pandemics may be difficult to assess or predict, it has caused, and may result in further significant

disruption of global financial markets, which may reduce our ability to access capital either at all or on favorable terms.

a recession, depression or other sustained adverse market event resulting from a health pandemic could materially and adversely affect

our business and the value of our common stock.

For example, as a result of COVID-19, we previously

experienced delays from our manufacturers with respect to the shipping of our materials as well as delays in completion of analytical

testing as a result of the shelter-in-place order restrictions.

Pandemics, such as COVID-19, may have a material economic effect on our

business because our research and development may be affected as a result of delays in study monitoring and data analysis;

some participants

and clinical investigators may not be able to comply with clinical trial protocols;

any quarantines or other travel limitations (whether

voluntary or required) may impede participant movement, affect sponsor access to study sites, or interrupt healthcare services, resulting

in our inability to conduct our research activities, including our clinical trials;

and infections and deaths related to a pandemic may

disrupt the United States’ healthcare and healthcare regulatory systems which could divert healthcare resources away from, or materially

delay FDA review and/or approval of our product candidates.

While the potential economic impact brought by such pandemics may be difficult

to assess or predict, it has caused, and may result in further significant disruption of global financial markets, which may reduce our

ability to access capital either at all or on favorable terms.

In addition, a recession, depression or other sustained adverse market

event resulting from a health pandemic could materially and adversely affect our business and the value of our common stock.

may expend our limited resources to pursue a particular drug candidate or indication and fail to capitalize on drug candidates or indications

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The term “remuneration” has been broadly interpreted to include anything of value.

false claims and false statement laws, including the federal civil False Claims Act and the Civil

Monetary Penalties Law (“ CMPL”), prohibits, among other things, any person or entity from knowingly presenting,

or causing to be presented, for payment to, or approval by, federal programs, including Medicare and Medicaid, claims for items or

services, including drugs, that are false or fraudulent.

false claims and false statement laws, including the federal civil False Claims Act and the Civil Monetary Penalties Law (“CMPL”),

prohibits, among other things, any person or entity from knowingly presenting, or causing to be presented, for payment to, or approval

by, federal programs, including Medicare and Medicaid, claims for items or services, including drugs, that are false or fraudulent.

Insurance Portability and Accountability Act of 1996 (“HIPAA”) created additional federal criminal statutes that prohibit

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obtain the active ingredient for our product candidates as required could harm our business.

currently source the active ingredient for TH1940, TH3215 and TH0059 from sole suppliers/manufacturers.

currently source the active ingredient for HS1940, HS3215 and HS0059 from sole suppliers/manufacturers.

In addition, we anticipate that

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Although we believe that we can obtain the active

ingredient for TH1940, TH3215, TH0059 and TH104 from other suppliers, supply shortages for these particular raw material may delay our

ingredient for HS1940, HS3215, HS0059 and TH104 from other suppliers, supply shortages for these particular raw material may delay our

clinical trials.

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On the federal

level, the Affordable Care Act (“ ACA”) was enacted in March 2010, and included

measures to significantly change the way healthcare is financed by both governmental and private insurers.

Among the provisions of the

ACA that have been of greatest importance to the pharmaceutical and biotechnology industry are the following:

level, the Affordable Care Act (“ACA”) was enacted in March 2010, and included measures to significantly change the way healthcare

is financed by both governmental and private insurers.

Among the provisions of the ACA that have been of greatest importance to the pharmaceutical

and biotechnology industry are the following:

annual, nondeductible fee on any entity that manufactures or imports certain branded prescription drugs and biologic agents, apportioned

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third-party submission of prior art to the U.S.

Patent and Trademark Office (“ USPTO”)

during patent prosecution and additional procedures to attack the validity of a patent by USPTO administered post-grant proceedings,

including post-grant review, inter parties review, and derivation proceedings.

Patent and Trademark Office (“USPTO”) during patent prosecution and additional

procedures to attack the validity of a patent by USPTO administered post-grant proceedings, including post-grant review, inter parties

review, and derivation proceedings.

In addition, the Leahy-Smith Act has transformed the U.S.

patent system from a “first-to-invent” system to a “first-to-file” system in which, assuming that other requirements

for patentability are met, the first inventor to file a patent application will be entitled to the patent on an invention regardless

of whether a third party was the first to invent the claimed invention.

patent system from a “first-to-invent”

system to a “first-to-file” system in which, assuming that other requirements for patentability are met, the first inventor

to file a patent application will be entitled to the patent on an invention regardless of whether a third party was the first to invent

the claimed invention.

addition, the patent positions of companies in the development and commercialization of biologics and pharmaceuticals are particularly

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may encounter difficulties in managing our growth, which could adversely affect our operations.

of February 20, 2024, we had 2 full-time employee and 1 part-time employee.

of March 1, 2025, we had 2 full-time employees and 1 part-time employee.

As our clinical development and commercialization plans and

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therefore be limited to the appreciation of their stock.

to maintain effective internal controls could cause our investors to lose confidence in us and adversely affect the market price of our

common stock.

If our internal controls are not effective, we may not be able to accurately report our financial results or prevent fraud.

internal control over financial reporting is necessary for us to provide reliable financial reports in a timely manner.

In connection

with the audit of our financial statements for the years ended December 31, 2023 and 2022, our independent registered public accounting

firm identified a material weakness.

A material weakness is a significant deficiency, or a combination of significant deficiencies, in

internal controls over financial reporting such that it is reasonably possible that a material misstatement of the annual or interim

financial statements will not be prevented or detected on a timely basis.

The material weaknesses that have been identified by our independent

registered public accounting firm relate to (i) the design and implementation of appropriate segregation of duties to separate the roles

of authorizing, initiating, and recording transactions or reviewing transactions for the completeness and accuracy of contracts with

financial reporting implications and (ii) us lacking sufficient appropriate accounting and reporting knowledge to effectively perform

review controls surrounding technical accounting matters.

While we have initiated a procedure to remediate the material weakness by reviewing

the material contracts on a quarterly basis with the accounting department and supporting staff and intend to use third party experts

to review the accounting treatment for significant transactions and provide management with guidance on the treatment of the transactions,

we may not be successful in remediating such weaknesses in a timely manner, if at all, which may undermine our ability to provide accurate,

timely and reliable reports on our financial and operating results.

Furthermore, if we remediate our current material weakness but identify

new material weaknesses in our internal control over financial reporting in the future, investors may lose confidence in the accuracy

and completeness of our financial reports and the market price of our common stock may be negatively affected.

As a result of such failures,

we could also become subject to investigations by Nasdaq, the SEC, or other regulatory authorities, and become subject to litigation

from investors and stockholders, which could harm our reputation, financial condition or divert financial and management resources from

our business.

Certificate of Incorporation, as amended (“Certificate of Incorporation”) provides that the Court of Chancery of the State

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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-K

Item 1A. Risk Factors