6 unchanged sentences
This summary does not address all of the risks that we face.
−Removed: Additional discussion of the risks summarized in this risk factor summary, and other risks that we face, can be found below in these “Risk Factors” and should be carefully considered, together with other information in this Quarterly Report on Form 10-Q and our other filings with the SEC, before making an investment decision regarding our common stock.
+Added: Additional discussion of the risks summarized in this risk factor summary, and other risks that we face, can be found below in these “Risk Factors” and should be carefully
+Added: considered, together with other information in this Quarterly Report on Form 10-Q and our other filings with the SEC, before making an investment decision regarding our common stock.
● We have no approved products and no historical commercial revenue, which makes it difficult to assess our future prospects and financial results.
39 unchanged sentences
We cannot be certain that our product candidates will receive regulatory approval or, if approved, be successfully commercialized.
−Removed: The research, testing, manufacturing, labeling, approval, sale, marketing and distribution of our product candidates will be subject to
−Removed: extensive regulation by the FDA and other regulatory authorities in the United States and other countries.
+Added: The research, testing, manufacturing, labeling, approval, sale, marketing and distribution of our product candidates will be subject to extensive regulation by the FDA and other regulatory authorities in the United States and other countries.
In addition, even if approved, our pricing and reimbursement will be subject to further review and discussions with payors.
22 unchanged sentences
We may experience delays in ongoing clinical trials, and we do not know whether planned clinical trials will begin on time, need to be redesigned, enroll patients on time or be completed on schedule, if at all.
−Removed: For example, we initially experienced slower than expected patient enrollment in VERIFY, a global Phase 3 clinical trial of rusfertide in PV.
+Added: For example, we initially experienced slower than expected patient enrollment in VERIFY, a global Phase 3 clinical trial of rusfertide in
Clinical trials can be delayed for a variety of reasons, including if a clinical trial is modified, suspended or terminated by us.
3 unchanged sentences
For example, our rusfertide clinical studies were subject to a three-week clinical hold by the FDA beginning in September 2021.
−Removed: The clinical hold was triggered by a non-clinical finding in a 26-week rasH2 transgenic mouse model
−Removed: indicating benign and malignant subcutaneous skin tumors.
+Added: The clinical hold was triggered by a non-clinical finding in a 26-week rasH2 transgenic mouse model indicating benign and malignant subcutaneous skin tumors.
Also, in April 2022, the FDA indicated that it intended to rescind Breakthrough Therapy Designation for rusfertide in PV, and we voluntarily withdrew our request.
4 unchanged sentences
Delays or failures in planned patient enrollment or retention may result in increased costs, program delays or both.
−Removed: In addition, we are subject to risks and uncertainties as a result of the ongoing military conflict in Ukraine and Russia.
−Removed: For example, in 2022 we closed down clinical trial sites in Russia and Ukraine at which a limited number of subjects were enrolled in our PN-943 Phase 2 IDEAL trial.
If we experience material delays in the completion of any clinical trial, the reduction in remaining patent term would harm the commercial prospects for that product candidate and our ability to generate product revenue from any of these product candidates will be delayed.
12 unchanged sentences
If such side effects or adverse events are sufficiently severe or prevalent, the FDA or comparable foreign regulatory authorities could order us to suspend or cease altogether further development of our product candidates.
−Removed: Even if our product candidates are approved, side effects or adverse events could result in significant delay in or denial of, regulatory approval, restrictive labeling, or potential product liability claims.
+Added: Even if our product candidates are approved, side
+Added: effects or adverse events could result in significant delay in or denial of, regulatory approval, restrictive labeling, or potential product liability claims.
Moreover, for our product candidates that are in development for indications for which injectable antibody drugs have been approved, clinical trials for those product candidates may need to show a risk/benefit profile that is competitive with those existing products in order to obtain regulatory approval or, if approved, a product label that is favorable for commercialization.
12 unchanged sentences
We have incurred significant annual operating losses each year since inception and may continue to incur operating losses for the foreseeable future.
−Removed: As of June 30, 2024, we had an accumulated deficit of $439.0 million.
+Added: As of September 30, 2024, we had an accumulated deficit of $472.2 million.
We expect to continue to incur significant research, development and other expenses related to our ongoing operations and product development.
9 unchanged sentences
Further, in the event that the JNJ License and Collaboration Agreement or the Takeda Collaboration Agreement is terminated, we may not receive any additional fees or milestone payments under these agreements.
−Removed: Absent the funding support obtained under these agreements, our further development of the collaboration product candidates would require significant additional capital from us, or the establishment of alternative collaborations with third parties, which may not be possible.
−Removed: As of June 30, 2024, we had cash, cash equivalents and marketable securities of $595.4 million.
+Added: Absent the funding support obtained under these agreements, our further development of the collaboration product
+Added: candidates would require significant additional capital from us, or the establishment of alternative collaborations with third parties, which may not be possible.
+Added: As of September 30, 2024, we had cash, cash equivalents and marketable securities of $583.3 million.
Based upon our current operating plan and expected expenditures we believe that our existing cash, cash equivalents, and marketable securities will be sufficient to fund our operations for at least the next 12 months.
−Removed: However, we may need to
−Removed: have access to additional funds in the future in order to complete clinical development or commercialize our product candidates to a point where our operations generate net cash inflows.
+Added: However, we may need to have access to additional funds in the future in order to complete clinical development or commercialize our product candidates to a point where our operations generate net cash inflows.
Raising additional capital may cause dilution to our existing stockholders, restrict our operations or require us to relinquish rights to our product candidates or technologies.
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We expect to expand the size of our organization in the future, and we may experience difficulties in managing this growth.
−Removed: As of June 30, 2024, we had 125 full-time equivalent employees, including 97 full-time equivalent employees engaged in research and development.
+Added: As of September 30, 2024, we had 126 full-time equivalent employees, including 98 full-time equivalent employees engaged in research and development.
As our development and commercialization plans and strategies develop, we expect to need additional managerial, operational, scientific, sales, marketing, research, development, regulatory, manufacturing, financial and other resources.
166 unchanged sentences
Our stock price has fluctuated in the past and is likely to be volatile in the future.
−Removed: From January 1, 2024 through June 30, 2024, the reported sale price of our common stock has fluctuated between $21.43 and $35.96 per share.
+Added: From January 1, 2024 through September 30, 2024, the reported sale price of our common stock has fluctuated between $21.43 and $48.00 per share.
The stock market in general and the market for biotechnology companies in particular have experienced extreme volatility that has often been unrelated to the operating performance of particular companies.
42 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.