77 unchanged sentences
We have incurred significant net losses since our inception.
−Removed: Due to revenue recognized from our collaboration arrangement with Biogen, we had net income of $183.4 million and $73.6 million for the three and six months ended June 30, 2023, respectively.
−Removed: We had net losses of $58.8 million and $124.0 million for the comparable three and six month periods ended June 30, 2022, respectively.
−Removed: As of June 30, 2023 , we had an accumulated deficit of $897.4 million .
+Added: Our net losses were $99.4 million and $25.8 million for the three and nine months ended September 30, 2023, respectively.
+Added: We had net losses of $103.3 million and $227.3 million for the comparable three and nine month periods ended September 30, 2022, respectively.
+Added: As of September 30, 2023 , we had an accumulated deficit of $996.7 million .
We have invested significant financial resources in research and development activities, including for our preclinical and clinical product candidates and our TV platform.
57 unchanged sentences
Even if we are successful in developing our product candidates, obtaining regulatory approvals and launching and commercializing any product candidate will require substantial additional funding.
−Removed: As of June 30, 2023, we had $1.19 billion in cash, cash equivalents and marketable securities.
+Added: As of September 30, 2023, we had $1.12 billion 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.
21 unchanged sentences
For example, the COVID-19 pandemic caused a temporary disruption in our ability to recruit participants for our clinical trials in the calendar year 2020 and the first quarter of 2021.
−Removed: While it is not possible to predict whether another pandemic, epidemic or infectious disease outbreak similar to COVID-19 will materialize, any measures taken by the governments of countries and local authorities in response to such future health crises have the potential to disrupt and delay the initiation of new clinical trials, the progress of our ongoing clinical trials, and could disrupt and delay our preclinical activities, and potentially the manufacture or shipment of both drug substance and finished drug product of our product candidates for preclinical testing and clinical trials and adversely impact our business, financial condition or operating results.
+Added: While it is not possible to predict whether another pandemic, epidemic or infectious disease outbreak similar to COVID-19 will materialize, any measures taken by governments and local authorities in response to such future health crises have the potential to disrupt and delay the initiation of new clinical trials, the progress of our ongoing clinical trials, and our preclinical activities, and potentially the manufacture or shipment of both drug substance and finished drug product of our product candidates for preclinical testing and clinical trials, as well as adversely impact our business, financial condition or operating results.
The continued impact of the COVID-19 pandemic may materially and adversely affect our business, operations and financial condition.
7 unchanged sentences
Should the FDA issue additional guidance that mandates material changes to our clinical trials in response to a pandemic or other public health outbreaks, the costs of such clinical trials may increase.
−Removed: To the extend we experience any ongoing pandemic disruptions or other public health emergencies, including a resurgence of COVID-19 cases, potential impacts to our business may include:
+Added: To the extent we experience any ongoing pandemic disruptions or other public health emergencies, including a resurgence of COVID-19 cases, potential impacts to our business may include:
• delays or difficulties in enrolling patients in our clinical trials, particularly elderly subjects, who are at a higher risk of complications from COVID-19 or other public health outbreaks;
36 unchanged sentences
Further, we canno t be certain that any of our product candidates will be successful in clinical trials.
−Removed: For instance, in June 2020, together with our collaboration partner Sanofi, we paused clinical activities with DNL747 to accelerate development of SAR443820/DNL788, in part due to DNL747 preclinical chronic toxicity studies.
+Added: For instance, in August 2023, together with our collaboration partner Takeda, we discontinued development of TAK-920/DNL919 (ATV:TREM2) in Alzheimer’s disease based on data from the Phase 1 study and the rapidly evolving treatment landscape and shifted our efforts to exploring back-up molecules.
We may in the future advance product candidates into clinical trials and terminate such trials prior to their completion.
68 unchanged sentences
Refer to “Item 1.
−Removed: Business—Our Programs” for a more detailed discussion of adverse effects ("AEs") and significant adverse effects ("SAEs") observed in our reported clinical trials for BIIB122/DNL151 and DNL310.
+Added: Business—Our Programs” of Form 10-K for a more detailed discussion of adverse effects ("AEs") and significant adverse effects ("SAEs") observed in our reported clinical trials for BIIB122/DNL151 and DNL310.
We may in the future advance product candidates into clinical trials and terminate such trials prior to their completion, which could adversely affect our business.
226 unchanged sentences
Adverse events or other undesirable side effects caused by our product candidates could cause us 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, BIIB122/DNL151, DNL310, SAR443820/DNL788, and SAR443122/DNL758, DNL343, TAK-290/DNL919, and TAK-594/DNL593 are currently our only clinical stage product candidates.
+Added: Our most advanced product candidates, BIIB122/DNL151, DNL310, SAR443820/DNL788, and eclitasertib or SAR443122/DNL758, DNL343, and TAK-594/DNL593 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.
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For example, the United States and foreign government actions related to Russia's invasion of Ukraine may limit our ability to make or prevent us from making these payments in Russia.
−Removed: These actions could result in abandonment or lapse of our patents or patent applications, resulting in partial or complete loss of patent rights in Russia, which could adversely effect our business.
+Added: These actions could result in abandonment or lapse of our patents or patent applications, resulting in partial or complete loss of patent rights in Russia, which could adversely affect our business.
Changes in U.S.
146 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, 2023, we had approximately 438 emplo yees, all of whom were full-time.
+Added: As of September 30, 2023, we had approximately 447 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.
143 unchanged sentences
If we raise additional funds through strategic partnerships and alliances and licensing arrangements with third parties, we may have to relinquish valuable rights to our technologies or product candidates, or grant licenses on terms unfavorable to us.
−Removed: In January 2020, we sold 9.0 million shares of common stock in an underwritten follow-on offering pursuant to a shelf registration statement filed in March 2019, and in February 2022 we filed a second shelf registration statement and simultaneously entered into an equity distribution agreement with Goldman Sachs & Co.
+Added: In January 2020, we sold 9.0 million shares of common stock in an underwritten follow-on offering pursuant to a shelf registration statement filed in March 2019, and in October 2022, we sold 11.9 million shares of common stock in an underwritten public offering pursuant to a second shelf registration statement filed in February 2022.
+Added: Also in February 2022, we entered into an equity distribution agreement with Goldman Sachs & Co.
LLC, SVB Securities LLC, and Cantor Fitzgerald & Co., as sales agents, to establish an at-the-market facility pursuant to which we may offer and sell from time to time up to $400.0 million shares of our common stock.
−Removed: In October 2022, we sold 11.9 million shares of common stock in an underwritten public offering pursuant to this second shelf registration statement.
Our decision to issue debt or equity securities in any future offering will depend on market conditions and other factors beyond our control, and therefore we cannot predict or estimate the amount, timing, or nature of any future offerings.
57 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.