7 unchanged sentences
• the timing, progress, and results of our preclinical studies and clinical trials for our product candidates, and the timing, scope or likelihood of regulatory filings and approvals for any of our product candidates;
−Removed: • our ability to develop and advance any future product candidates based on our novel proprietary RPx platform and successfully complete clinical trials;
+Added: • our ability to develop and advance any future product candidates based on our novel proprietary RPx platform and successfully complete clinical trials and prepare for and successfully complete inspections and submissions of licensing applications;
• our ability to develop our product candidates for use in combination with other checkpoint blockade therapies, including anti-PD-1;
18 unchanged sentences
We have not generated any revenues from the sale of products and do not expect to do so for at least the next several years.
−Removed: Our lead product candidate, RP1, and any other product candidates will require extensive preclinical and/or clinical testing and regulatory approval prior to commercial use.
+Added: Our lead product candidate, RP1, and any other product candidates will require extensive preclinical and/or clinical testing and regulatory review prior to approval and commercial use.
Our research and development efforts may not be successful.
23 unchanged sentences
• changes could be adopted in marketing approval policies during the development period, rendering our data insufficient to obtain marketing approval;
−Removed: • statutes or regulations could be amended or new ones could be adopted, especially in light of the upcoming reauthorization of the Prescription Drug User Fee Act;
+Added: • statutes or regulations could be amended or new ones could be adopted;
• changes could be adopted in the regulatory review process for submitted product applications;
11 unchanged sentences
• the FDA or comparable foreign regulatory authorities may disagree with our intended indications;
−Removed: • the FDA or comparable foreign regulatory authorities may fail to approve or subsequently find fault with the manufacturing, testing, comparability or quality processes or our manufacturing facilities for clinical and future commercial supplies;
+Added: • the FDA or comparable foreign regulatory authorities may fail to approve or subsequently find fault with the manufacturing, testing, comparability or quality processes or our manufacturing facilities for clinical and future commercial supplies and may delay approval, refuse to approve or rescind approval of a product candidate;
• the data collected from clinical trials of our product candidates, including our registration directed or registration intended trials, may not be sufficient to the satisfaction of the FDA or comparable foreign regulatory authorities to support the submission of a BLA or other comparable submission in foreign jurisdictions or to obtain regulatory approval in the United States or elsewhere;
63 unchanged sentences
Securing marketing approval also requires the submission of information about the product manufacturing process to, and inspection of manufacturing facilities and clinical trial sites by, the regulatory authorities.
−Removed: If we do not receive approval from the FDA and comparable foreign regulatory authorities for any of our product candidates, we will not be able to commercialize such product candidates in the United States or in other jurisdictions.
+Added: If we do not receive approval from the FDA or comparable foreign regulatory authorities for any of our product candidates, we will not be able to commercialize such product candidates in the United States or in other jurisdictions.
If significant delays in obtaining approval for and commercializing our product candidates occur in any jurisdictions, our business, financial condition, results of operations, stock price and prospects will be materially harmed.
266 unchanged sentences
We are not profitable and have incurred losses in each period since our inception.
−Removed: For the three months ended June 30, 2024 and 2023, we reported a net loss of $53.8 million and $49.6 million, respectively.
−Removed: At June 30, 2024, we had an accumulated deficit of $755.1 million.
+Added: For the six months ended September 30, 2024 and 2023, we reported a net loss of $106.8 million and $109.6 million, respectively.
+Added: At September 30, 2024, we had an accumulated deficit of $808.1 million.
We expect to continue to incur significant losses for the foreseeable future, and we expect these losses to increase as we continue our research and development of, and seek marketing approvals for, RP1, our other product candidates and any additional product candidates we may develop.
23 unchanged sentences
Our operations have consumed substantial amounts of cash since inception.
−Removed: At June 30, 2024, our cash and cash equivalents and short-term investments were $469.1 million.
+Added: At September 30, 2024, our cash and cash equivalents and short-term investments were $432.1 million.
We expect to continue to spend substantial amounts to continue the clinical and preclinical development of RP1 and our other product candidates.
15 unchanged sentences
Until we can generate sufficient product revenue to finance our cash requirements, which we may never do, we expect to finance our future cash needs through a combination of public or private equity offerings, debt financings, collaborations, strategic alliances, licensing arrangements and other marketing or distribution arrangements.
−Removed: Based on our current operating plan, we expect that our existing cash and cash equivalents and short-term investments, as of June 30, 2024 will enable us to fund operations into the second half of 2026 which includes scale up for the commercialization of RP1 in skin cancers and for working capital and general corporate purposes.
+Added: Based on our current operating plan, we expect that our existing cash and cash equivalents and short-term investments, as of September 30, 2024 will enable us to fund operations into the second half of 2026 which includes scale up for the commercialization of RP1 in skin cancers and for working capital and general corporate purposes.
We have based this estimate on assumptions that may prove to be wrong, and we could exhaust our available capital resources sooner than we expect.
476 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.