Anthera Pharmaceuticals (ANTH) Risk Analysis
Risk Overview Q1, 2018
Source: the company's latest filing for the period ended Mar 31, 2018, filed May 15, 2018
Risk Change Over Time
No filing history is available.
- Trade Secrets - Risk 1If our or our licensors' patent positions do not adequately protect our product candidates or any future products, others could compete with us more directly or prevent us from commercializing our products, which would harm our business.
- we or our licensors were the first to make the inventions covered by each of our pending patent applications;- we or our licensors were the first to file patent applications for these inventions;- others will not independently develop similar or alternative technologies or duplicate any of our technologies;- any of our or our licensors' pending patent applications will result in issued patents;- any of our or our licensors' patents will be valid or enforceable;- any patents issued to us or our licensors and collaborators will provide a basis for commercially viable products, will provide us with any competitive advantages or will not be challenged by third-parties;- we will develop additional proprietary technologies or product candidates that are patentable; or - the patents of others will not have an adverse effect on our business.
- Trade Secrets - Risk 2If we breach the license agreement for blisibimod, we could lose the ability to continue the development and commercialization of blisibimod. Our product candidates may cause undesirable adverse effects or have other properties that could delay or prevent their regulatory approval or limit the commercial profile of any approved label.
Although we are not currently conducting any clinical studies, undesirable adverse effects caused by our product candidates could cause us, IRBs or other reviewing entities, clinical study sites, or regulatory authorities to interrupt, delay or halt clinical studies and could result in the denial of regulatory approval by the FDA or other regulatory authorities. If serious adverse events related to our product candidates are observed in any clinical studies, our ability to obtain regulatory approval for our product candidates may be adversely impacted. Further, if our product candidates receive marketing approval and we or others later discover, after approval and use in an increasing number of patients, that our products could have adverse effect profiles that limit their usefulness or require their withdrawal (whether or not the therapies showed the adverse effect profile in Phase 1 through Phase 3 clinical studies), a number of potentially significant negative consequences could result, including: - regulatory authorities may withdraw their approval of or revoke the licenses for the products; - regulatory authorities may require the addition of labeling statements, such as warnings or contraindications; - we may be required to change the way the products are administered, conduct additional clinical studies or change the labeling of the products; - we could be sued and held liable for harm caused to patients; and - our reputation may suffer. Any of these events could prevent us from achieving or maintaining market approval and acceptance of the affected product candidates and could substantially increase the costs of commercialization. - issue warning letters or untitled letters;- seek an injunction or impose civil or criminal penalties or monetary fines;- suspend or withdraw regulatory approval or revoke a license;- suspend any ongoing clinical studies;- refuse to approve pending applications or supplements to applications filed by us;- suspend or impose restrictions on operations, including costly new manufacturing requirements; or - seize or detain products, refuse to permit the import or export of products, or require us to initiate a product recall. The occurrence of any event or penalty described above may inhibit our ability to commercialize our products and generate revenue.
Risk Highlights Q1, 2018
Risk Word Cloud
Risk Factors Full Breakdown - Total Risks 38
- Share Price & Shareholder Rights - Risk 1Our stock price has been and will likely continue to be volatile, which could result in the decline of the value of your investment in our common stock or class action litigation against us and our management, which could cause us to incur substantial costs and divert management's attention and resources.
The market price for our common stock has been and is likely to continue to be volatile. In addition, the market price of our common stock may fluctuate significantly in response to a number of factors, most of which we cannot predict or control, including: - plans for, progress in and results from clinical studies for our product candidates;- announcements of new products, services or technologies, commercial relationships, acquisitions or other events by us or our competitors;- developments concerning proprietary rights, including those pertaining to patents patent applications held by our licensors;- failure of any of our product candidates, if approved, to achieve commercial success;- general market conditions and overall fluctuations in U.S. equity markets;- variations in our operating results, or the operating results of our competitors;- changes in our financial guidance or securities analysts' estimates of our financial performance;- changes in accounting principles;- sales of large blocks of our common stock, including sales by our executive officers, directors and significant stockholders;- publication of research reports about us or our industry or positive or negative recommendations or withdrawal of research coverage by securities analysts;- additions or departures of any of our key personnel;- announcements related to litigation;- changing legal or regulatory developments in the United States and other countries; and - discussion of us or our stock price by the financial press and in online investor communities. Although our common stock is listed for trading on the Nasdaq Capital Market, our securities have been relatively thinly traded. Investor trading patterns could serve to exacerbate the volatility of the price of the stock. Accordingly, it may be difficult to sell shares of common stock quickly without significantly depressing the value of the stock. Unless we are successful in developing continued investor interest in our stock, sales of our stock could result in major fluctuations in the price of the stock. In addition, the stock market in general, and The Nasdaq Capital Market in particular, have experienced substantial price and volume volatility that is often seemingly unrelated to the operating performance of particular companies. These broad market fluctuations may cause the trading price of our common stock to decline. In the past, securities class action litigation has often been brought against a company after a period of volatility in the market price of its common stock. Securities litigation against us, including as discussed elsewhere in this Form 10-K, could result in substantial expenses and the diversion of our management's attention and resources and could harm our business, operating results and financial condition.
- Share Price & Shareholder Rights - Risk 2Future sales of our common stock by the selling stockholders could cause our stock price to decline.
Sales of a substantial number of shares of our common stock by the selling stockholders in the public market or the perception that these sales might occur, could depress the market price of our common stock and could impair our ability to raise capital through the sale of additional equity securities, even if there is no relationship between such sales and the performance of our business. As of February 28, 2018, there were 23,397,497 shares of our common stock outstanding. In addition, we had outstanding 2,067,522 shares of Class Y Convertible Preferred Stock that are convertible into 2,067,522 shares of common stock, and options and warrants to purchase 26,520,407 shares of our common stock that, if converted and exercised, will result in these additional shares becoming available for sale. A large portion of these shares and outstanding equity awards are held by a small number of persons and investment funds. Sales by these stockholders or option holders in the public market or the perception that these sales might occur, could depress the market price of our common stock and could impair our ability to raise capital through the sale of additional equity securities, even if there is no relationship between such sales and the performance of our business.
- Share Price & Shareholder Rights - Risk 3We may be unable to issue securities under our shelf registration statement, which may have an adverse effect on our liquidity.
We have filed a shelf registration statement on Form S-3 with the SEC. The registration statement is subject to Instruction I.B.6. of Form S-3, which imposes a limitation on the maximum amount of securities that we may sell pursuant to the registration statement during any twelve-month period. When we sell securities pursuant to the registration statement, the amount of securities to be sold plus the amount of any securities we have sold during the prior twelve months in reliance on Instruction I.B.6. may not exceed one-third of the aggregate market value of our outstanding common stock held by non-affiliates as of a day during the 60 days immediately preceding such sale, as computed in accordance with Instruction I.B.6. Based on this calculation and the current market value of our outstanding common stock, we expect that we will be significantly limited to selling additional securities pursuant to our effective registration statement on Form S-3, unless and until the market value of our outstanding common stock held by non-affiliates increases significantly. If we cannot sell securities under our shelf registration, we may be required to utilize more costly and time-consuming means of accessing the capital markets, which could materially adversely affect our liquidity and cash position.
- Share Price & Shareholder Rights - Risk 4Anti-takeover provisions in our charter documents and under Delaware law could make an acquisition of us, which may be beneficial to our stockholders, more difficult and may prevent attempts by our stockholders to replace or remove our current management.
Provisions in our amended and restated certificate of incorporation and amended and restated bylaws may delay or prevent an acquisition of us or a change in our management. These provisions include: - a classified and staggered board of directors whose members can only be dismissed for cause;- the prohibition on actions by written consent of our stockholders;- the limitation on who may call a special meeting of stockholders;- the establishment of advance notice requirements for nominations for election to our board of directors or for proposing matters that can be acted upon at stockholder meetings;- the ability of our board of directors to issue preferred stock without stockholder approval, which would increase the number of outstanding shares and could thwart a takeover attempt; and - the requirement of at least 75% of the outstanding common stock to amend any of the foregoing provisions. In addition, because we are incorporated in Delaware, we are governed by the provisions of Section 203 of the Delaware General Corporation Law, which limits the ability of stockholders owning in excess of 15% of our outstanding voting stock to merge or combine with us. Although we believe these provisions collectively provide for an opportunity to obtain greater value for stockholders by requiring potential acquirers to negotiate with our board of directors, they would apply even if an offer rejected by our board were considered beneficial by some stockholders. In addition, these provisions may frustrate or prevent any attempts by our stockholders to replace or remove our current management by making it more difficult for stockholders to replace members of our board of directors, which is responsible for appointing the members of our management.
See a full breakdown of risk according to category and subcategory. The list starts with the category with the most risk. Click on subcategories to read relevant extracts from the most recent report.