77 unchanged sentences
We have incurred significant net losses since our inception.
−Removed: Our net losses were $99.0 million and $200.8 million for the three and six months ended June 30, 2024, respectively.
−Removed: We had net income of $183.4 million and $73.6 million for the three and six months ended June 30, 2023, respectively.
−Removed: As of June 30, 2024 , we had an accumulated deficit of $1.32 billion .
+Added: Our net losses were $107.2 million and $308.0 million for the three and nine months ended September 30, 2024, respectively, and net losses of $99.4 million and $25.8 million for the three and nine months ended September 30, 2023, respectively.
+Added: As of September 30, 2024 , we had an accumulated deficit of $1.42 billion .
We have invested significant financial resources in research and development activities, including for our preclinical and clinical product candidates and our TV platform.
54 unchanged sentences
Our operations have required substantial amounts of cash since inception.
−Removed: We currently fund our operations primarily with the proceeds from our follow-on offering completed in October 2022, payments received from our collaboration agreements with Biogen, Sanofi, and Takeda, and a PIPE transaction completed in February 2024.
+Added: We currently fund our operations primarily with the proceeds from our follow-on offering completed in October 2022, payments received from our collaboration agreements with Biogen, Sanofi, and Takeda, and a strategic private offering transaction completed in February 2024.
We have a diversified portfolio with numerous programs at various stages of research, discovery, preclinical, and clinical development .
1 unchanged sentence
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, 2024, we had $1.35 billion in cash, cash equivalents and marketable securities.
+Added: As of September 30, 2024, we had $1.28 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.
210 unchanged sentences
The same risks would apply to our internal manufacturing facilities and capabilities, which we are actively building in Salt Lake City, Utah.
−Removed: Under an operating lease for approximately 60,000 rentable square feet of laboratory, office, and warehouse premises, we have initiated the build-out of our Utah site to expand our clinical manufacturing capabilities for biologic therapeutics including the manufacture of materials for toxicology studies and drug substance for early human clinical studies.
+Added: Under a lease for approximately 60,000 rentable square feet of laboratory, office, and warehouse premises, we have initiated the build-out of our Utah site to expand our clinical manufacturing capabilities for biologic therapeutics including the manufacture of materials for toxicology studies and drug substance for early human clinical studies.
In addition, building internal manufacturing capacity carries significant risks in terms of being able to plan, design, and execute on a complex project to build manufacturing facilities in a timely and cost-efficient manner.
146 unchanged sentences
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, BIIB122/DNL151, DNL310, SAR443820/DNL788, eclitasertib (SAR443122/DNL758), DNL343, and TAK-594/DNL593 are currently our only clinical stage product candidates.
+Added: Our most advanced product candidates, BIIB122/DNL151, DNL310, eclitasertib (SAR443122/DNL758), DNL343, TAK-594/DNL593, and DNL126 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.
579 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, 2024, we had approximately 364 emplo yees, all of whom were full-time.
+Added: As of September 30, 2024, we had approximately 390 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
Certain holders of shares of our common stock have rights, subject to conditions, to require us to file registration statements covering their shares or to include their shares in registration statements that we may file for ourselves or other stockholders.
−Removed: For example, on February 27, 2024, we entered into a Purchase Agreement with certain existing accredited investors in connection with a PIPE financing.
+Added: For example, on February 27, 2024, we entered into a Purchase Agreement with certain existing accredited investors in connection with a strategic private offering transaction.
Pursuant to this Purchase Agreement, we entered into an agreement granting an investor certain registration rights following such time that the investor may be deemed an affiliate of the Company.
11 unchanged sentences
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 in shares of our common stock.
−Removed: On February 27, 2024, we announced a PIPE financing in which we sold 3,244,689 shares of our common stock and pre-funded warrants to purchase 26,046,065 shares of our common stock, resulting in net proceeds of approximately $499.3 million.
+Added: On February 27, 2024, we announced a strategic private offering transaction in which we sold 3,244,689 shares of our common stock and pre-funded warrants to purchase 26,046,065 shares of our common stock, resulting in net proceeds of approximately $499.3 million.
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.