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Risks Related to our Financial Position and Capital Needs
−Removed: We have incurred significant losses since our inception.
−Removed: We expect to incur losses over the next several years and may never achieve or maintain profitability.
−Removed: These factors raise substantial doubt regarding our ability to continue as a going concern.
−Removed: Since our inception, we have incurred significant net losses, and we expect to continue to incur significant expenses and operating losses for the foreseeable future.
−Removed: Our net losses were $174.5 million and $60.0 million for the years ended December 31, 2021 and 2020, respectively.
−Removed: As of December 31, 2021, we had an accumulated deficit of $235.6 million.
−Removed: We have financed our operations with $359.0 million in gross proceeds from equity financings, including from our initial public offering, the sale of common stock pursuant to our Sales Agreement and private placements of convertible preferred stock, and from our loan agreement with Silicon Valley Bank.
−Removed: We have no products approved for commercialization and have never generated any revenue from product sales.
−Removed: All of our product candidates are still in the clinical or preclinical development stage.
−Removed: We expect to continue to incur significant expenses and operating losses over the next several years.
−Removed: We expect that it could be several years, if ever, before we have a commercialized product.
−Removed: Our net losses may fluctuate significantly from quarter to quarter and year to year.
−Removed: We anticipate that our expenses will increase substantially as we:
−Removed: continue to advance the preclinical and clinical development of our product candidates and preclinical and discovery programs;
−Removed: conduct our ongoing clinical trials of TSHA-102, TSHA-118, TSHA-120 and TSHA-121, as well as initiate and complete additional clinical trials of TSHA-105 and any other current and future product candidates that we advance;
−Removed: seek regulatory approval for any product candidates that successfully complete clinical trials;
−Removed: continue to develop our gene therapy product candidate pipeline and next-generation platforms;
−Removed: scale up our clinical and regulatory capabilities;
−Removed: manufacture current good manufacturing practice, or cGMP, material for clinical trials or potential commercial sales;
−Removed: establish and validate a commercial-scale cGMP manufacturing facility;
−Removed: establish a commercialization infrastructure and scale up internal and external manufacturing and distribution capabilities to commercialize any product candidates for which we may obtain regulatory approval;
−Removed: adapt our regulatory compliance efforts to incorporate requirements applicable to marketed products;
−Removed: maintain, expand and protect our intellectual property portfolio;
−Removed: hire additional clinical, manufacturing quality control, regulatory, manufacturing and scientific and administrative personnel;
−Removed: add operational, financial and management information systems and personnel, including personnel to support our product development and planned future commercialization efforts;
−Removed: incur additional legal, accounting and other expenses in operating as a public company.
−Removed: To date, we have not generated any revenue.
−Removed: To become and remain profitable, we must succeed in developing and eventually commercializing product candidates that generate significant revenue.
−Removed: This will require us to be successful in a range of challenging activities, including completing preclinical testing and clinical trials of our product candidates, obtaining regulatory approval, and manufacturing, marketing and selling any product candidates for which we may obtain regulatory approval, as well as discovering and developing additional product candidates.
−Removed: We are only in the preliminary stages of most of these activities and all of our product candidates are in clinical or preclinical development.
−Removed: We may never succeed in these activities and, even if we do, may never generate any revenue or revenue that is significant enough to achieve profitability.
−Removed: Even if we achieve profitability, we may not be able to sustain or increase profitability on a quarterly or annual basis.
−Removed: Our failure to become and remain profitable would depress the value of our company and could impair our ability to raise capital, expand our business, maintain our development efforts, obtain product approvals, diversify our offerings or continue our operations.
−Removed: A decline in the value of our company could also cause you to lose all or part of your investment.
−Removed: These and other factors raise substantial doubt regarding our ability to continue as a going concern, which may create negative reactions to the price of our common stock.
−Removed: If we are unable to continue as a going concern, we may have to liquidate our assets and may receive less than the value at which those assets are carried on our financial statements, and it is likely that investors will lose all or a part of their investment.
−Removed: Further, the perception that we may be unable to continue as a going concern may impede our ability to pursue strategic opportunities or operate our business due to concerns regarding our ability to discharge our contractual obligations.
−Removed: In addition, if there remains substantial doubt about our ability to continue as a going concern, investors or other financing sources may be unwilling to provide additional funding to us on commercially reasonable terms, or at all.
Unfavorable global economic conditions could adversely affect our business, financial condition or results of operations.
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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.