8 unchanged sentences
We expect to incur losses over at least the next several years and may never achieve or maintain profitability.
−Removed: Our net loss was $ 143.9 million for the fiscal year ended November 30, 2023, and $86.1 million for the six months ended May 31, 2024.
−Removed: As of May 31, 2024, we had an accumulated deficit of $631.3 million.
+Added: Our net loss was $ 143.9 million for the fiscal year ended November 30, 2023, and $135.0 million for the nine months ended August 31, 2024.
+Added: As of August 31, 2024, we had an accumulated deficit of $680.2 million.
To date, we have not generated any revenue from product sales and have financed our operations primarily through our collaborations and sales of our equity interests.
35 unchanged sentences
If we are unable to raise capital when needed or on attractive terms, we may be required to delay, limit, reduce or terminate our research, product development programs or any future commercialization efforts or grant rights to develop and market drug candidates that we otherwise would prefer to develop and market ourselves.
−Removed: We had cash, cash equivalents and marketable securities of $452.5 million as of May 31, 2024.
+Added: We had cash, cash equivalents and marketable securities of $457.5 million as of August 31, 2024.
We believe that our existing cash, cash equivalents and marketable securities will be sufficient to fund our operating expenses and capital expenditure requirements through at least the next 12 months.
158 unchanged sentences
The results of preclinical studies and early-stage clinical trials may not be predictive of future results.
−Removed: Initial success in clinical trials may not be indicative of results obtained when these trials are completed or in later-stage trials.
−Removed: The results of preclinical studies may not be predictive of the results of clinical trials, and the results of any early-stage clinical trials we commence may not be predictive of the results of the later-stage clinical trials.
+Added: Initial success in clinical trials may not be indicative of results obtained in later-stage trials or when these trials are completed.
+Added: The results of preclinical studies may not be predictive of the results of clinical trials, and the results of any early-stage clinical trials we commence may not be predictive of the results of the later-stage clinical trials or when these trials are completed.
In addition, initial success in clinical trials may not be indicative of results obtained when such trials are completed.
196 unchanged sentences
Some of our suppliers may experience disruption to their respective supply chain due to the effects of macroeconomic conditions, which could delay, prevent or impair our development or commercialization efforts.
−Removed: We obtain certain chemical or biological intermediates in the synthesis of our drug candidates and natural health products (NHPs) for toxicology testing in countries affected by macroeconomic events and conditions, including inflation, increasing interest rates, uncertainty with respect to the federal budget and debt ceiling and potential government shutdowns related thereto, increasing financial market volatility and uncertainty, the impact of war or military conflict, including regional conflicts around the world, and public health pandemics.
+Added: We obtain certain chemical or biological intermediates in the synthesis of our drug candidates and natural health products (NHPs) for toxicology testing in countries affected by macroeconomic events and conditions, including inflation, interest rate fluctuations, uncertainty with respect to the federal budget and debt ceiling and potential government shutdowns related thereto, increasing financial market volatility and uncertainty, the impact of war or military conflict, including regional conflicts around the world, and public health pandemics.
If we are unable to obtain these chemical or biological intermediates or NHPs in sufficient quantity and in a timely manner due to disruptions in the global supply chain caused by macroeconomic events and conditions, the development, testing and clinical trials of that drug candidate may be delayed or infeasible, and regulatory approval or commercial launch of any resulting product may be delayed or not obtained, which could significantly harm our business.
593 unchanged sentences
Our future revenues, profitability and cash flows could also be materially and adversely affected and our ability to obtain a return on the investments we have made in those drug candidates may be substantially limited if our drug candidates, if and when approved, are not afforded the appropriate periods of non-patent exclusivity.
−Removed: If any of our drug candidates are not considered to be a new active substance or are deemed to fall within the “global marketing authorization” of an existing medicinal product or if pediatric studies are not adequately completed, this may result in lack of regulatory data protection or failure to obtain an extension to existing regulatory data protection.
+Added: If any of our drug candidates are not considered to be a new active substance or are deemed to fall within the “global marketing authorization” of an existing medicinal product or if pediatric studies are not adequately completed, such drug candidates may fail to obtain regulatory data protection or an extension to existing regulatory data protection.
Where an applicant for a marketing authorization submits a full dossier containing its own pharmaceutical, preclinical tests and clinical trials data, and where the application does not fall within the “global marketing authorization” of an existing medicinal product, the applicant is entitled to eight years of regulatory data protection upon grant of the marketing authorization (the period starts to run from the first marketing authorization in the EU and EEA).
58 unchanged sentences
If we are slow or unable to adapt to changes in existing requirements or the adoption of new requirements or policies, or if we are not able to maintain regulatory compliance, we may lose any marketing approval that we may have obtained, and we may not achieve or sustain profitability.
−Removed: We also cannot predict the likelihood, nature or extent of government regulation that may arise from future legislation or administrative or executive action, either in the United States or abroad.
+Added: We also cannot predict the likelihood, nature or extent of government regulation that may arise from future legislation, judicial or administrative or executive action, either in the United States or abroad.
Current and future legislation may increase the difficulty and cost for us, and any collaborators, to obtain marketing approval of and commercialize our drug candidates and affect the prices we, or they, may obtain.
266 unchanged sentences
For example, the global financial crisis of 2007-2008 caused extreme volatility and disruptions in the capital and credit markets.
−Removed: Similarly, the volatility associated with the COVID-19 pandemic caused significant instability and disruptions in the capital and credit markets and, more recently, the global economy has been impacted by increasing interest rates and inflation, uncertainty with respect to the federal budget and debt ceiling and potential government shutdowns related thereto, as well as the possibility of a recession or further economic downturn.
+Added: Similarly, the volatility associated with the COVID-19 pandemic caused significant instability and disruptions in the capital and credit markets and, more recently, the global economy has been impacted by interest rate fluctuations and inflation, uncertainty with respect to the federal budget and debt ceiling and potential government shutdowns related thereto, as well as the possibility of a recession or further economic downturn.
Moreover, there have been recent concerns with respect to the stability of the global banking system.
33 unchanged sentences
• regulatory developments affecting our drug candidates or those of our competitors;
−Removed: • changes in general market and economic conditions, including increasing interest rates, inflation, uncertainty with respect to the federal budget and debt ceiling and potential government shutdowns related thereto, instability in the global banking system and the possibility of a recession or further economic downturn.
+Added: • changes in general market and economic conditions, including interest rate fluctuations, inflation, uncertainty with respect to the federal budget and debt ceiling and potential government shutdowns related thereto, instability in the global banking system and the possibility of a recession or further economic downturn.
If our quarterly results of operations fall below the expectations of investors or securities analysts, the price of our common stock could decline substantially.
32 unchanged sentences
• natural disasters and other calamities;
−Removed: • general economic, industry and market conditions, including increasing interest rates, inflation, uncertainty with respect to the federal budget and debt ceiling and potential government shutdowns related thereto, instability in the global banking system and the possibility of a recession or further economic downturn.
+Added: • general economic, industry and market conditions, including interest rate fluctuations, inflation, uncertainty with respect to the federal budget and debt ceiling and potential government shutdowns related thereto, instability in the global banking system and the possibility of a recession or further economic downturn.
In addition, the stock market in general, and the markets for pharmaceutical, biopharmaceutical and biotechnology stocks in particular, have experienced extreme price and volume fluctuations that often have been unrelated or disproportionate to the operating performance of the issuer.
22 unchanged sentences
In August 2021, we entered into an Equity Distribution Agreement (Equity Distribution Agreement) with Piper Sandler & Co.
−Removed: (Piper Sandler) pursuant to which, from time to time, we may offer and sell through Piper Sandler up to $150.0 million of the common stock registered under the shelf registration statement pursuant to one or more “at the market” offerings.
−Removed: In June 2022, we issued and sold 2,000,000 shares of common stock and in May 2024, we issued and sold 3,194,809 shares of our common stock under the Equity Distribution Agreement to Piper Sandler.
−Removed: As of May 31, 2024, we had $79.8 million of common stock remaining available for sale pursuant to the Equity Distribution Agreement.
−Removed: In July 2024, we amended the Equity Distribution Agreement to provide for offerings of up to $150.0 million.
−Removed: As of July 11, 2024, we had $150.0 million of common stock remaining available for sale pursuant to the Equity Distribution Agreement.
−Removed: Sales of our common stock under the Equity Distribution Agreement with Piper Sandler could be subject to business, economic or competitive uncertainties and contingencies, many of which may be beyond our control, and which could cause actual results from the sale of our common stock to differ materially from expectations.
−Removed: In addition, in July 2022, we entered into separate Securities Purchase Agreements with certain purchasers to issue and sell pre-funded warrants to purchase an aggregate of 6,814,920 shares of our common stock in registered direct offerings.
−Removed: Such pre-funded warrants are immediately exercisable, have an exercise price of $0.001 and may be exercised at any time after the date of issuance.
+Added: (Piper Sandler), which was amended in July 2024 (as amended, the Amended Equity Distribution Agreement), pursuant to which, from time to time, we may offer and sell through Piper Sandler up to $150.0 million of the common stock registered under the shelf registration statement pursuant to one or more “at the market” offerings.
+Added: In June 2022, we issued and sold 2,000,000 shares of common stock under the Equity Distribution Agreement;
+Added: in May 2024, we issued and sold 3,194,809 shares of our common stock under the Equity Distribution Agreement;
+Added: in August 2024, we issued and sold 2,145,000 shares of common stock under the Amended Equity Distribution Agreement;
+Added: and in October 2024, we issued and sold 3,711,770 shares of common stock under the Amended Equity Distribution Agreement.
+Added: As of the date of this filing, we have $27.3 million of common stock remaining available for sale under the Amended Equity Distribution Agreement.
+Added: Sales of our common stock under the Amended Equity Distribution Agreement with Piper Sandler could be subject to business, economic or competitive uncertainties and contingencies, many of which may be beyond our control, and which could cause actual results from the sale of our common stock to differ materially from expectations.
To the extent additional capital is raised through the sale and issuance of shares or other securities convertible into shares, the ownership interest of our stockholders will be diluted.
3 unchanged sentences
however, any exercise would increase the number of shares eligible for future resale in the public market and result in substantial dilution to our stockholders.
−Removed: As of May 31, 2024, we have issued pre-funded warrants to purchase a total of 8,315,020 shares of our common stock, of which 7,597,660 were outstanding as of May 31, 2024.
+Added: As of August 31, 2024, we have issued pre-funded warrants to purchase a total of 8,315,020 shares of our common stock, of which 7,597,660 were outstanding as of August 31, 2024.
Each pre-funded warrant is exercisable for $0.001 per share of common stock underlying such pre-funded warrant, which may be paid by way of a cashless exercise, meaning that the holder may not pay a cash purchase price upon exercise, but instead would receive upon such exercise the net number of shares of common stock determined according to the formula set forth in the pre-funded warrant.
90 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.