addition to the other information set forth in this Quarterly Report on Form 10-Q, consider the risk factors discussed in Part 1, “Item
−Removed: Risk Factors” in the Company’s 2024 Form 10-K, filed with the SEC on March 13, 2025, and the risk factors discussed in Item 1A of the Quarterly Report on Form
−Removed: 10-Q for the quarter ended March 31, 2025, filed with the SEC on May 8, 2025, and in this Quarterly Report on Form 10-Q, which could
−Removed: materially affect our business, financial condition or future results.
−Removed: The risks described in the aforementioned reports are not the
−Removed: only risks facing the Company.
−Removed: Additional risks and uncertainties not currently known to the Company or that it currently deems to be
−Removed: not material also may materially adversely affect the Company’s business, financial condition, and/or operating results.
+Added: Risk Factors” in the Company’s 2024 Form 10-K, filed with the SEC on March 13, 2025, the risk factors discussed in Item
+Added: 1A of the Quarterly Report on Form 10-Q for the quarter ended March 31, 2025, filed with the SEC on May 8, 2025, the risk factors discussed
+Added: in Item 1A of the Quarterly Report on Form 10-Q for the quarter ended June 30, 2025, filed with the SEC on August 5, 2025 and in this
+Added: Quarterly Report on Form 10-Q, which could materially affect our business, financial condition or future results.
+Added: The risks described
+Added: in the aforementioned reports are not the only risks facing the Company.
+Added: Additional risks and uncertainties not currently known to the
+Added: Company or that it currently deems to be not material also may materially adversely affect the Company’s business, financial condition,
+Added: and/or operating results.
following are the risk factors that have materially changed from our risk factors included in our 2024 Form 10-K:
19 unchanged sentences
of LPCN 1154, if approved.
−Removed: If we are unable to successfully partner or otherwise develop and get regulatory approval for LPCN 1154,
−Removed: LPCN 1154 may never be commercialized.
+Added: If we are unable to successfully partner or otherwise develop and get regulatory approval for LPCN 1154, LPCN
+Added: 1154 may never be commercialized.
can be no assurance there will not be any third-party patent infringement proceedings against us.
7 unchanged sentences
management and directors will be able to exert influence over our affairs.
−Removed: of June 30, 2025, our executive officers and directors beneficially owned approximately 6.5% of our common stock.
+Added: of September 30, 2025, our executive officers and directors beneficially owned approximately 6.5% of our common stock.
These stockholders,
30 unchanged sentences
We have incurred losses in most years since our inception.
−Removed: As of June 30, 2025, we had an accumulated deficit of approximately
+Added: As of September 30, 2025, we had an accumulated deficit of approximately
$207.0 million.
4 unchanged sentences
We expect to continue to incur significant research
−Removed: and development expenses in connection with clinical trials associated with LPCN 1154 and LPCN 2401, and potentially with LPCN 2101,
−Removed: LPCN 2203, LPCN 1148, LPCN 1144 and LPCN 1107, if further clinical trials are initiated.
−Removed: As a result, we expect to continue to incur
−Removed: significant operating losses for the foreseeable future as we evaluate further clinical development of LPCN 1154, LPCN 2401, LPCN 2101,
−Removed: LPCN 2203, and possibly LPCN 1148, LPCN 1144, and LPCN 1107, in addition to our other programs and continued research efforts.
−Removed: of the numerous risks and uncertainties associated with developing pharmaceutical products, we are unable to predict the extent of any
−Removed: future losses or when we will become profitable, if at all.
+Added: and development expenses in connection with clinical trials associated with LPCN 1154, and potentially with LPCN 2101, LPCN 2401, LPCN
+Added: 2203, LPCN 1148, and LPCN 1107, if further clinical trials are initiated.
+Added: As a result, we expect to continue to incur significant operating
+Added: losses for the foreseeable future as we evaluate further clinical development of LPCN 1154, LPCN 2101, LPCN 2401, LPCN 2203, and possibly
+Added: LPCN 1148 and LPCN 1107, in addition to our other programs and continued research efforts.
+Added: Because of the numerous risks and uncertainties
+Added: associated with developing pharmaceutical products, we are unable to predict the extent of any future losses or when we will become profitable,
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.