RISK FACTORS
An investment in our securities involves a high degree of risk. You should carefully consider the risks described under “Risk Factors” in our most recent Annual Report onForm 10-K and Quarterly Reports onForm 10-Q, and all of the other information contained in this prospectus supplement and the accompanying base prospectus, and incorporated by reference into this prospectus supplement and the accompanying base prospectus, including our financial statements and related notes, before investing in our securities. If any of the possible adverse events described below or in those sections actually occur, our business, business prospects, cash flow, results of operations or financial condition could be harmed, the trading price of our common stock could decline, and you might lose all or part of your investment in our securities. Additional risks and uncertainties not presently known to us or that we currently deem immaterial may also impair our operations and results.
Risks Related to This Offering, Our Common Stock and the Warrants to Purchase Common Stock
We expect to continue to require external financing to fund our operations, which may not be available.
We expect to continue to require external financing to fund our near and long-term operations. Such financing may not be available on terms we deem acceptable or at all.
As of June 30, 2018, we had a cash balance of approximately $8.8 million. During the third quarter of 2018, we sold an aggregate of 6,633,903 shares of common stock inat-the-market offerings pursuant to our equity distribution agreement with Canaccord for aggregate net proceeds of $4.51 million after deducting sales agent fees and expenses. Based on shares of our common stock (excluding common stock issuable upon exercise of the warrants to purchase common stock being sold in this offering) being sold at the public offering price of $ per share, we estimate we will receive aggregate net proceeds of approximately $ million, after deducting underwriting discounts and commissions and estimated aggregate offering expenses payable by us. We may be required to raise additional funds in order to continue as a going concern.
There is substantial doubt concerning our ability to continue as a going concern.
Our financial statements have been prepared assuming that we will continue as a going concern, which contemplates the realization of assets and satisfaction of liabilities in the normal course of business. Our history and other operating circumstances raise substantial doubt about our ability to continue as a going concern. As a result of this uncertainty and the substantial doubt about our ability to continue as a going concern as of December 31, 2017, the Report of Independent Registered Public Accounting Firm included immediately prior to the Consolidated Financial Statements included in our Annual Report onForm 10-K, includes a going concern explanatory paragraph. Even if we successfully complete this offering, there will continue to be substantial doubt about our ability to continue as a going concern. We will need to raise additional funds. However, no assurance can be given at this time as to whether we will be able to raise these funds. Our financial statements do not include any adjustment relating to the recoverability and classification of recorded asset amounts or the amounts and classification of liabilities that might be necessary should we be unable to continue as a going concern.
The FDA may not accept a BLA submission for NeoCart and, even if the FDA accepts and files our BLA, the FDA may not approve NeoCart.
We have scheduled a meeting with the FDA on October 30, 2018, to discuss the results of our Phase 3 clinical trial of NeoCart announced in the third quarter of 2018 and the potential BLA submission. There can be no assurance that the FDA will accept a BLA submission for filing for NeoCart, in particular in light of the results of our Phase 3 clinical trial, in which NeoCart did not meet its primary endpoint. In the event that the FDA determines that the data from our Phase 3 clinical trial or other required information are not sufficiently complete to permit a substantive review of a BLA, we would need to evaluate our ability to generate additional data or conduct additional trials that might permit a BLA submission. There can be no assurance that we would be able to generate any additional data, conduct any additional trials or that the additional data would support a filing of the BLA, and, as a result, we may be unable to seek FDA approval for NeoCart. Further, even if the FDA files our BLA for NeoCart, the results of our Phase 3 clinical trial may decrease the likelihood that the FDA approves NeoCart. If we are unable to seek FDA approval for NeoCart or if the FDA denies approval for NeoCart, we will be unable to commercialize NeoCart. If we are not able to commercialize NeoCart, or are significantly delayed in doing so, our business will be materially harmed and we may need to curtail or cease operations.
An active trading market for our common stock may not develop or be sustained and investors may not be able to resell their shares at or above the price at which they purchased them.
Since our initial public offering in December 2014, there has generally been limited trading activity in our common stock. An active trading market for our shares may never develop or be sustained. In the absence of an active trading market for our common stock, investors may not be able to sell their common stock at or above the price they paid or at the time that they would like to sell. In addition, an inactive market may impair our ability to raise capital by selling shares and may impair our ability to acquire other companies or technologies by using our shares as consideration, which, in turn, could harm our business.
The warrants may never have any value.
The warrants, which have an exercise price of $ per whole share of common stock, will expire five years after issuance. In the event our common stock price does not exceed the per share exercise price of the warrants during the period when the warrants are exercisable, the warrants will not have any value.
There is no public market for the warrants to purchase common stock being offered in this offering.
There is no established public trading market for the warrants being offered in this offering, and we do not expect a market to develop. In addition, we do not intend to apply for listing of the warrants on any national securities exchange or other trading market. Without an active market, the liquidity of the warrants will be limited.
Holders of our warrants will have no rights as a common stockholder until such holders exercise their warrants and acquire our common stock.
Until you acquire shares of our common stock upon exercise of your warrants, you will have no rights with respect to the shares of our common stock underlying such warrants. Upon exercise of your warrants, you will be entitled to exercise the rights of a common stockholder only as to matters for which the record date occurs after the exercise date.
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