What changed in this filing

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Item 1A. Risk Factors

2026-08-04 compared with 2026-05-07 · 39 added, 34 removed, 22 unchanged (77% of the section changed)

addition to the other information set forth in this Quarterly Report on Form 10-Q, consider the risk factors discussed in Part 1, “Item

Risk Factors” in the Company’s 2025 Form 10-K and the risk factors discussed in Item 1A of this Quarterly Report on Form

10-Q, which could materially affect our business, financial condition or future results.

The risks described in the aforementioned reports

are not the only risks facing the Company.

Risk Factors” in the Company’s 2025 Form 10-K, the risk factors discussed in Item 1A of the Quarterly Report on Form

10-Q for the quarter ended March 31, 2026 filed with the SEC on May 7, 2026, and the risk factors discussed in Item 1A of this Quarterly

Report on Form 10-Q, which could materially affect our business, financial condition or future results.

The risks described in the aforementioned

reports are not the only risks facing the Company.

Additional risks and uncertainties not currently known to the Company or that it currently

3 unchanged sentences

management and directors will be able to exert influence over our affairs.

of March 31, 2026, our executive officers and directors beneficially owned approximately 4.7% of our common stock.

of June 30, 2026, our executive officers and directors beneficially owned approximately 6.9% of our common stock.

These stockholders,

5 unchanged sentences

market price and trading volume of our common stock has been volatile over the past year and it may continue to be volatile.

past year, our common stock has traded as low as $2.53 and as high as $11.26 per share.

We cannot predict the price at which our common

stock will trade in the future and it may decline.

The price at which our common stock trades may fluctuate significantly and may be

influenced by many factors, including our financial results;

For the prior twelve months ending June 30, 2026, our common stock has traded as low as $1.94 and as high as $11.26 per share .

We cannot predict the price at which

our common stock will trade in the future and it may decline.

The price at which our common stock trades may fluctuate significantly

and may be influenced by many factors, including our financial results;

developments generally affecting our industry;

general economic, industry

and market conditions, and our customers;

general economic,

industry and market conditions, and our customers;

the depth and liquidity of the market for our common stock;

investor perceptions of our business;

investor perceptions of

our business;

reports by industry analysts;

announcements by other market participants, including, among others, investors, our competitors, and our

announcements by other market participants, including, among others, investors, our competitors,

and our customers;

regulatory action affecting our business;

and the impact of other “Risk Factors” discussed herein and in our 2025

In addition, changes in the trading price of our common stock may be inconsistent with our operating results and outlook.

and the impact of other “Risk Factors” discussed herein and

in our 2025 Form 10-K.

In addition, changes in the trading price of our common stock may be inconsistent with our operating results and

The volatility of the market price of our common stock may be inconsistent with our operating results and outlook.

The volatility of

the market price of our common stock may adversely affect investors’ ability to purchase or sell shares of our common stock.

The volatility

of the market price of our common stock may adversely affect investors’ ability to purchase or sell shares of our common stock.

Relating to Our Financial Position and Capital Requirements

1 unchanged sentence

foreseeable future.

have focused a significant portion of our efforts on developing TLANDO and more recently on LPCN 1154, LPCN 1148, and LPCN 1144.

funded our operations to date through sales of our equity securities, debt and payments received under our license and collaboration

arrangements.

have focused a significant portion of our efforts on developing TLANDO and more recently on LPCN 1154 and LPCN 1148.

We have funded our operations to date through sales of our equity securities, debt and payments received under our license and

collaboration arrangements.

We have incurred losses in most years since our inception.

As of March 31, 2026, we had an accumulated deficit of $213.1

Substantially all of our operating losses resulted from costs incurred in connection with our research and development programs

and from general and administrative costs associated with our operations.

These losses, combined with expected future losses, have had

and will continue to have an adverse effect on our stockholders’ equity.

It is possible that we will continue to incur significant

research and development expenses in connection with clinical trials associated with LPCN 1154, and potentially with LPCN 2201, LPCN

2101, LPCN 2203, LPCN 2401, LPCN 1148, and LPCN 1107, if further clinical trials are initiated.

As a result, we expect to continue to

incur significant operating losses for the foreseeable future as we evaluate further clinical development of LPCN 1154, LPCN 2201, LPCN

2101, LPCN 2203, LPCN 2401, and possibly LPCN 1148 and LPCN 1107, in addition to our other programs and continued research efforts.

of the numerous risks and uncertainties associated with developing pharmaceutical products, we are unable to predict the extent of any

future losses or when we will become profitable, if ever.

As of June 30, 2026, we had an accumulated

deficit of $215.7 million.

Substantially all of our operating losses resulted from costs incurred in connection with our research

and development programs and from general and administrative costs associated with our operations.

These losses, combined with

expected future losses, have had and will continue to have an adverse effect on our stockholders’ equity.

It is possible that

we will continue to incur significant research and development expenses in connection with clinical trials associated with LPCN

1154, and potentially with LPCN 2201, LPCN 2203, LPCN 2101, LPCN 2401, LPCN 1148, and LPCN 1107, if further clinical trials are

As a result, we expect to continue to incur significant operating losses for the foreseeable future as we evaluate

further clinical development of LPCN 1154, LPCN 2201, LPCN 2203, LPCN 2101, LPCN 2401, and possibly LPCN 1148 and LPCN 1107, in

addition to our other programs and continued research efforts.

Because of the numerous risks and uncertainties associated with

developing pharmaceutical products, we are unable to predict the extent of any future losses or when we will become profitable, if

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 1A. Risk Factors