43 unchanged sentences
We have never generated any revenue from product sales and have incurred net losses each year since we commenced operations.
−Removed: For the three months ended March 31, 2026 and 2025, our net losses were $24.4 million and $23.5 million, respectively.
+Added: For the six months ended June 30, 2026 and 2025, our net losses were $46.3 million and $57.4 million, respectively.
We expect that it will be several years, if ever, before we have a product candidate ready for regulatory approval and commercialization.
13 unchanged sentences
In addition, if we obtain marketing approval for any of our product candidates, we expect to incur significant commercialization expenses related to marketing, sales, manufacturing and distribution.
−Removed: As of March 31, 2026, we had $956.4 million in cash, cash equivalents and short-term investments.
+Added: As of June 30, 2026, we had $970.9 million in cash, cash equivalents and short-term investments.
Based upon our current operating plan, we estimate that our existing cash, cash equivalents and short-term investments will be sufficient to fund our operating expenses and capital expenditure requirements for at least the next 12 months following the date of this Quarterly Report.
545 unchanged sentences
We expect to expand our development, regulatory and operational capabilities and, as a result, we may encounter difficulties in managing our growth, which could disrupt our operations.*
−Removed: As of March 31, 2026, we had 108 full-time employees.
+Added: As of June 30, 2026, we had 113 full-time employees.
As we advance our research and development programs, we will be required to further increase the number of our employees and the scope of our operations, particularly in the areas of research and clinical development, medical affairs, general and administrative matters relating to being a public company, regulatory affairs and, if any of our product candidates receives marketing approval, sales, marketing and distribution.
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In such circumstances, our future product revenue and financial condition would be materially and adversely affected.
−Removed: Specifically, there are many companies pursuing a variety of approaches to immuno-oncology and autoimmune disease treatments, including large pharmaceutical and biotechnology companies, such as AbbVie, Amgen, AstraZeneca, Biogene, Bristol Myers Squibb, Eli Lilly, Gilead, GlaxoSmithKline, Johnson & Johnson, Merck & Co., Novartis, Pfizer, Regeneron, Roche/Genentech, Sanofi, Takeda and Xencor.
−Removed: Other companies using PSMA-targeting therapeutics for the treatment of cancer include AbbVie, Amgen, AstraZeneca, Bayer, Crescendo Biologics, Eli Lilly, GlaxoSmithKline, Johnson and Johnson, Lantheus, Lava Therapeutics, Novartis, Regeneron and Vir Biotechnology.
−Removed: We also face competition from biologic prodrug developers such as Adagene, Chugai Pharmaceutical Co./Roche Holding AG, CytomX Therapeutics, Merck & Co., Takeda and Vir Biotechnology.
+Added: Specifically, there are many companies pursuing a variety of approaches to immuno-oncology and autoimmune disease treatments, including large pharmaceutical and biotechnology companies such as AbbVie, Amgen, Astellas, AstraZeneca, Bayer, BeOne Medicines, Boehringer Ingelheim, Bristol Myers Squibb, Chugai Pharmaceutical, Eli Lilly, Gilead, GlaxoSmithKline, Johnson & Johnson, Merck & Co., Novartis, Pfizer, Regeneron, Roche/Genentech, Sanofi and Takeda, as well as clinical-stage and emerging biotechnology companies, including Adagene, Aktis Oncology, Argenx, Cabaletta Bio, Climb Bio, Context Therapeutics, Cullinan Therapeutics, CytomX Therapeutics, Dianthus Therapeutics, Immatics, Immunocore, Kyverna Therapeutics, Lava Therapeutics, Vir Biotechnology, Werewolf Therapeutics, Xencor, Xilio Therapeutics and Zenas Bio.
+Added: These companies are developing products that may compete with our product candidates across multiple therapeutic modalities, molecular targets and therapeutic technologies,
+Added: including T cell engagers, radiopharmaceuticals, antibody-drug conjugates, cell therapies, and masked and conditionally activated biologics.
Many of our competitors, either alone or with their collaboration partners, have significantly greater financial resources and expertise in research and development, preclinical testing, clinical trials, manufacturing and marketing than we do.
113 unchanged sentences
The EU Clinical Trials Regulation, or CTR, which was adopted in April 2014 and repeals the EU Clinical Trials Directive, became effective on January 31, 2022.
−Removed: The CTR permits trial sponsors to make a single submission to both the competent authority and an ethics committee in each EU Member State, leading to a single decision for each EU Member State.
−Removed: The assessment procedure for the authorization of clinical trials has been harmonized as well, including a joint assessment of some elements of the application by all EU Member States in which the trial is to be conducted, and a separate assessment by each EU Member State with respect to specific requirements related to its own territory, including ethics rules.
−Removed: Each EU Member State’s decision is communicated to the sponsor through a centralized EU portal, the Clinical Trial Information System, or CTIS.
−Removed: The CTR provides a three-year transition period.
−Removed: The extent to which ongoing clinical trials will be governed by the CTR varies.
−Removed: For clinical trials in relation to which an application for approval was made on the basis of the Clinical Trials Directive before January 31, 2023, the CTD will continue to apply on a transitional basis until January 31, 2025.
−Removed: By that date, all ongoing trials will become subject to the provisions of the CTR.
+Added: The CTR introduces, among other changes, a centralized application system, coordinated review procedures, expanded reporting and increased transparency obligations.
The CTR foresaw a three-year transition period that ended on January 31, 2025.
Since this date, all new or ongoing trials are subject to the provisions of the CTR.
+Added: Since this date, all new or ongoing trials are subject to the provisions of the CTR.
In the European Union, many EU Member States periodically review their reimbursement procedures for medicinal products, which could have an adverse impact on reimbursement status.
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A decrease in market exclusivity opportunities for our product candidates in the EU, combined with the expanded Bolar exemption, could open them to generic or biosimilar competition earlier than under the current regime, potentially impacting reimbursement status and the commercial prospects of our product candidates.
+Added: The new framework is expected to enter into force in late 2026 and to be subject to transitional arrangements, with full application not anticipated before 2028.
+Added: Other legislative initiatives in the EU include the proposed SPC Regulation revision, the proposed Critical Medicines Act (for which a provisional political agreement was reached in May 2026), and the proposed Biotech Act.
We and the third parties with whom we work are subject to stringent and evolving U.S.
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The price of our common stock could decline if there are substantial sales of our common stock, particularly sales by our directors, executive officers and significant stockholders, or if there is a large number of shares of our common stock available for sale and the market perceives that sales will occur.
−Removed: As of March 31, 2026, we had 60,865,458 outstanding shares of common stock.
+Added: As of June 30, 2026, we had 61,077,980 outstanding shares of common stock.
Future sales and issuances of our common stock or rights to purchase common stock, including pursuant to our equity incentive plans, could result in additional dilution of the percentage ownership of our stockholders and could cause our stock price to fall.
235 unchanged sentences
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.