76 unchanged sentences
We have incurred significant net losses since our inception.
−Removed: Our net losses were $124.1 million and $257.1 million for the three and six months ended June 30, 2025, respectively, and net losses of $99.0 million and $200.8 million for the three and six months ended June 30, 2024, respectively.
−Removed: As of June 30, 2025 , we had an accumulated deficit of $1.80 billion .
+Added: Our net losses were $126.9 million and $384.0 million for the three and nine months ended September 30, 2025, respectively, and net losses of $107.2 million and $308.0 million for the three and nine months ended September 30, 2024, respectively.
+Added: As of September 30, 2025 , we had an accumulated deficit of $1.92 billion .
We have invested significant financial resources in research and development activities, including for our preclinical and clinical product candidates and our TV platform.
39 unchanged sentences
• general economic conditions;
−Removed: • addressing any delays in our clinical trials or other impacts from a pandemic or other global health emergency.
+Added: • addressing any delays in our clinical trials or other impacts from a global emergency.
Because of the numerous risks and uncertainties associated with drug development, we are unable to predict the timing or amount of our expenses, or when we will be able to generate any meaningful revenue or achieve or maintain profitability, if ever.
11 unchanged sentences
Developing our product candidates is expensive, and we expect to continue to spend substa ntial amounts as we fund our early-stage research projects and advance our programs through preclinical and clinical development.
−Removed: As of June 30, 2025, we had $977.4 million in cash, cash equivalents and marketable securities.
+Added: As of September 30, 2025, we had $872.9 million in cash, cash equivalents and marketable securities.
We believe that our existing cash, cash equivalents and marketable securities will be sufficient to fund our projected operations through at least the next twelve months.
53 unchanged sentences
We cannot guarantee that any clinical trials will be conducted as planned or completed on schedule, if at all.
−Removed: We cannot be sure that submission of an investigational new drug application ("IND"), or a clinical trial application ("CTA"), will result in the FDA or EMA, as applicable, allowing clinical trials to begin in a timely manner, if at all.
+Added: We cannot be sure that submission of an investigational new IND, or a CTA, will result in the FDA or EMA, as applicable, allowing clinical trials to begin in a timely manner, if at all.
Moreover, even if these trials begin, issues may arise that could suspend or terminate such clinical trials.
50 unchanged sentences
• our ability to obtain and maintain patient consents;
−Removed: • the risk that patients enrolled in clinical trials will not complete such trials, for any reason, including the risk of higher drop-out rates if participants become infected with the global virus or other infectious diseases that impact their participation in our trials.
+Added: • the risk that patients enrolled in clinical trials will not complete such trials, for any reason.
Our inability to enroll and retain a sufficient number of patients for our clinical trials would result in significant delays or may require us to abandon one or more clinical trials altogether.
16 unchanged sentences
Additionally, any safety concerns observed in any one of our clinical trials in our targeted indications could limit the prospects for regulatory approval of our product candidates in those and other indications, which could have a material adverse effect on our business, financial condition, results of operations and growth prospects.
−Removed: Even if such clinical trials are successfully completed, we cannot guarantee that the FDA will approve the product candidates for the proposed indications, and more trials could be required before we submit our product candidates for approval.
−Removed: For instance, although the FDA has accepted our biologics license application ("BLA") for accelerated approval of DNL310, we expect the FDA will require us to conduct a confirmatory trial post any approval.
−Removed: To the extent that the results of the trials are not satisfactory to the FDA or foreign regulatory authorities for support of a marketing application, we may be required to expend significant resources, which may not be available to us, to conduct additional trials in support of potential approval of our product candidates.
+Added: Even if such clinical trials are successfully completed, we cannot guarantee that the FDA will approve the product candidates for the proposed indications, and more information or trials could be required before we submit our product candidates for approval.
+Added: For instance, although the FDA has accepted our biologics license application ("BLA") for accelerated approval of DNL310, our PDUFA target date was extended to enable the submission of updated clinical pharmacology information in response to an information request from the FDA.
+Added: It is also possible that the FDA could require us to conduct a confirmatory trial.
+Added: To the extent that the results of such trials are not satisfactory to the FDA or foreign regulatory authorities for support of a marketing application, we may be required to expend significant resources, which may not be available to us, to conduct additional trials in support of potential approval of our product candidates.
Even if regulatory approval is secured for any of our product candidates, the terms of such approval, such as requiring us to narrow our indications to a smaller subset, may also limit its commercial potential.
1 unchanged sentence
Adverse events or other undesirable side effects caused by our product candidates could cause us, our collaborators, or regulatory authorities to interrupt, delay, or halt clinical trials and could result in a more restrictive label or the delay or denial of regulatory approval by the FDA, EMA, or other comparable foreign regulatory authorities.
−Removed: Our most advanced product candidates, DNL310, DNL126, BIIB122/DNL151, eclitasertib (SAR443122/DNL758), and TAK-594/DNL593, are currently our only clinical stage product candidates.
+Added: Our most advanced product candidates, DNL310, DNL126, BIIB122/DNL151, eclitasertib (SAR443122/DNL758), TAK-594/DNL593, DNL628, and DNL952 are currently our only clinical stage product candidates.
Adverse events and other side effects may result from higher dosing, repeated dosing, and/or longer-term exposure to our product candidates and could lead to delays and/or termination of the development of these product candidates.
For example, in August 2023, together with our collaboration partner Takeda, we made the strategic decision to discontinue clinical development of TAK-920/DNL919 in Alzheimer's disease following a clinical hold by the FDA.
−Removed: In 2020, we paused clinical studies with DNL747 in our RIPK1 program.
−Removed: Chronic toxicity studies with DNL747 in cynomolgus monkeys showed dose- and duration-dependent adverse preclinical findings at exposures higher than those tested in the clinic.
−Removed: These findings, which are considered off-target and molecule-specific, may impact the ability to increase the dose of DNL747 and achieve higher levels of target inhibition without time consuming additional clinical safety studies in patients to evaluate the long-term safety and tolerability.
Drug-related side effects could affect patient recruitment, the ability of enrolled patients to complete the trial, and/or result in potential product liability claims.
748 unchanged sentences
We will need to grow the size and capabilities of our organization, and we may experience difficulties in managing this growth.
−Removed: As of June 30, 2025, we had approximately 486 emplo yees, all of whom were full-time.
+Added: As of September 30, 2025, we had approximately 517 emplo yees, all of whom were full-time.
As our development plans and strategies develop, we must add a significant number of additional managerial, operational, financial, and other personnel.
107 unchanged sentences
• failure or discontinuation of any of our product development and research programs;
−Removed: • failure to develop our TV platform;
+Added: • failure to commercialize our TV platform;
• results of preclinical studies, clinical trials, or regulatory approvals of product candidates of our competitors, or announcements about new research programs, product candidates, or technologies of our competitors;
94 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.