RISK FACTORS

You should consider the following factors in evaluating whether to adopt the Merger Agreement and thereby approve the transactions contemplated thereby, including the merger and the issuance of Ohr common stock to NeuBase’s stockholders pursuant to the terms of the Merger Agreement, the Ohr Reverse Stock Split and the Post-Merger Certificate of Incorporation. These factors should be considered in conjunction with the other information included or incorporated by reference by Ohr in this joint proxy statement/prospectus.

Risks Related to the Merger

If the proposed merger with NeuBase is not consummated, Ohr’s business could suffer materially and Ohr’s stock price could decline.

The consummation of the proposed merger with NeuBase is subject to a number of closing conditions, including the approval by Ohr’s stockholders, approval by Nasdaq of Ohr’s application for initial listing of Ohr common stock in connection with the merger, a minimum amount of financing into NeuBase, and other customary closing conditions. Ohr is targeting a closing of the transaction in the second quarter of calendar year 2019.

If the proposed merger is not consummated, Ohr may be subject to a number of material risks, and its business and stock price could be adversely affected, as follows:

In addition, if the Merger Agreement is terminated and the Ohr board of directors determines to seek another business combination, it may not be able to find a third party willing to provide equivalent or more attractive consideration than the consideration to be provided by each party in the merger. In such circumstances, the Ohr board of directors may elect to, among other things, divest all or a portion of Ohr’s assets, or take the steps necessary to liquidate all of Ohr’s business and assets, and in either such case, the consideration that Ohr receives may be less attractive than the consideration to be received by Ohr pursuant to the Merger Agreement.

The exchange ratio is not adjustable based on the market price of Ohr common stock so the merger consideration at the closing may have a greater or lesser value than at the time the Merger Agreement was signed.

The Merger Agreement has set the exchange ratio for the NeuBase common stock. Any changes in the market price of Ohr common stock before the completion of the merger will not affect the number of shares NeuBase securityholders will be entitled to receive pursuant to the Merger Agreement. Therefore, if before the completion of the merger the market price of Ohr common stock declines from the market price on the date of the Merger Agreement, then NeuBase securityholders could receive merger consideration with substantially lower value. Similarly, if before the completion of the merger the market price of Ohr common stock increases from the market price on the date of the Merger Agreement, then NeuBase securityholders could receive merger consideration with substantially more value for their shares of NeuBase capital stock than the parties had negotiated for in the establishment of the exchange ratio. Because the exchange ratio does not adjust as a result of changes in the value of Ohr common stock, for each one percentage point that the market value of Ohr common stock rises or declines, there is a corresponding one percentage point rise or decline, respectively, in the value of the total merger consideration issued to NeuBase securityholders.

Some of Ohr’s officers and directors have conflicts of interest that may influence them to support or approve the merger.

Officers and directors of Ohr participate in arrangements that provide them with interests in the merger that are different from yours, including, among others, Sam Backenroth’s, Ohr’s current Chief Financial Officer, continued employment as Chief Financial Officer of the combined company, their continued service as a director of the combined company, retention and severance benefits, the acceleration of option vesting and continued indemnification. These interests, among others, may influence the officers and directors of Ohr to support or approve the merger. For a more detailed discussion, please see the section entitled “The Merger—Interests of Ohr’s Directors and Executive Officers in the Merger” beginning on page 159 of this joint proxy statement/prospectus.

The market price of the combined company’s common stock may decline as a result of the merger.

The market price of the combined company’s common stock may decline as a result of the merger for a number of reasons including:

Ohr’s stockholders may not realize a benefit from the merger commensurate with the ownership dilution they will experience in connection with the merger.

If the combined company is unable to realize the strategic and financial benefits currently anticipated from the merger, Ohr’s stockholders will have experienced substantial dilution of their ownership interest without receiving any commensurate benefit. Significant management attention and resources will be required to integrate the two companies. Delays in this process could adversely affect the combined company’s business, financial results, financial condition and stock price following the merger. Even if the combined company were able to integrate the business operations successfully, there can be no assurance that this integration will result in the realization of the full benefits of synergies, innovation and operational efficiencies that may be possible from this integration and that these benefits will be achieved within a reasonable period of time.

During the pendency of the merger, Ohr may not be able to enter into a business combination with another party and will be subject to contractual limitations on certain actions because of restrictions in the Merger Agreement.

Covenants in the Merger Agreement impede the ability of Ohr or NeuBase to make acquisitions or complete other transactions that are not in the ordinary course of business pending completion of the merger. As a result, if the merger is not completed, the parties may be at a disadvantage to their competitors. In addition, while the Merger Agreement is in effect and subject to limited exceptions, each party is prohibited from soliciting, initiating, encouraging or taking actions designed to facilitate any inquiries or the making of any proposal or offer that could lead to entering into certain extraordinary transactions with any third party, such as a sale of assets, an acquisition of Ohr common stock, a tender offer for Ohr common stock, a merger or other business combination outside the ordinary course of business. Any such transactions could be favorable to such party’s stockholders.

The opinion received by the Ohr board of directors from Roth has not been, and is not expected to be, updated to reflect changes in circumstances that may have occurred since the date of the opinion.

Roth delivered its opinion to the Ohr board of directors of Ohr that, as of January 2, 2019, and based upon and subject to the various assumptions made, procedures followed, matters considered and qualifications and limitations set forth in its opinion, the merger consideration was fair, from a financial point of view, to Ohr. The opinion does not speak as of the time the merger will be completed or any date other than the date of such opinion. The opinion does not reflect changes that may occur or may have occurred after the date of the opinion, including changes to the operations and prospects of Ohr or NeuBase, changes in general market and economic conditions or regulatory or other factors. Any such changes may materially alter or affect the relative values of Ohr and NeuBase. Roth does not have any obligation to update, revise or reaffirm its opinion to reflect subsequent developments and has not done so. See the section of this joint proxy statement/prospectus entitled “The Merger—Opinion of Ohr’s Financial Advisor” beginning on page 149 and Annex D .

Certain stockholders could attempt to influence changes within Ohr which could adversely affect Ohr’s operations, financial condition and the value of Ohr common stock.

Ohr’s stockholders may from time-to-time seek to acquire a controlling stake in Ohr, engage in proxy solicitations, advance stockholder proposals or otherwise attempt to effect changes. Campaigns by stockholders to effect changes at publicly-traded companies are sometimes led by investors seeking to increase short-term stockholder value through actions such as financial restructuring, increased debt, special dividends, stock repurchases or sales of assets or the entire company. Responding to proxy contests and other actions by activist stockholders can be costly and time-consuming, and could disrupt Ohr’s operations and divert the attention of the Ohr board of directors and senior management from the pursuit of the proposed merger transaction. These actions could adversely affect Ohr’s operations, financial condition, Ohr’s ability to consummate the merger and the value of Ohr common stock.

Ohr and NeuBase may become involved in securities litigation or stockholder derivative litigation in connection with the merger, and this could divert the attention of Ohr and NeuBase management and harm the combined company’s business, and insurance coverage may not be sufficient to cover all related costs and damages.

Securities litigation or stockholder derivative litigation frequently follows the announcement of certain significant business transactions, such as the sale of a business division or announcement of a business combination transaction. Ohr and NeuBase may become involved in this type of litigation in connection with the merger, and the combined company may become involved in this type of litigation in the future. Litigation often is expensive and diverts management’s attention and resources, which could adversely affect the business of Ohr, NeuBase and the combined company.

On February 14, 2018, plaintiff, Jeevesh Khanna, commenced an action in the Southern District of New York, against Ohr and several current and former officers, alleging that they violated federal securities laws between June 24, 2014 and January 4, 2018. On August 7, 2018, the lead plaintiffs, now George Lehman and Insured Benefit Plans, Inc. filed an amended complaint, stating the class period to be April 8, 2014 through January 4, 2018. The plaintiffs did not quantify any alleged damages in their complaint but, in addition to attorneys’ fees and costs, they seek to maintain the action as a class action and to recover damages on behalf of themselves and other persons who purchased or otherwise acquired Ohr common stock during the putative class period and purportedly suffered financial harm as a result. Ohr and the individuals dispute these claims and intend to defend the matter vigorously. On September 17, 2018, Ohr filed a motion to dismiss the complaint. On November 13, 2018, plaintiffs filed a motion to strike exhibits appended to the motion to dismiss. A decision on the motion to strike is pending, and the motion to dismiss will then be fully briefed based on a schedule to be determined by the court. This litigation could result in substantial costs and a diversion of management’s resources and attention, which could harm Ohr’s business and the value of the Ohr common stock.

On May 3, 2018, plaintiff Adele J. Barke, derivatively on behalf of Ohr, commenced an action against Michael Ferguson, Orin Hirschman, Thomas M. Riedhammer, June Almenoff and Jason Slakter in the Supreme Court, State of New York, alleging that the action was brought in the right and for the benefit of Ohr seeking to remedy their “breach of fiduciary duties, corporate waste and unjust enrichment that occurred between June 24, 2014 and the present.” It does not quantify any alleged damages. Ohr and the individuals dispute these claims and intend to defend the matter vigorously. Such litigation has been stayed pursuant to a stipulation by the parties, which has been so ordered by the court, pending a decision in the Southern District case on the motion to dismiss, but that status could change. This litigation could result in substantial costs and a diversion of management’s resources and attention, which could harm Ohr’s business and the value of the Ohr common stock.

In September 2018, plaintiff John Tomson, derivatively and on behalf of Ohr, commenced an action against Michael Ferguson, Sam Backenroth, Irach Taraporewala, Orin Hirschman, Thomas M. Riedhammer, June Almenoff and Jason Slakter in the U.S. District Court for the Southern District of New York alleging that the action was brought in the right and for the benefit of Ohr seeking to remedy their various breaches of fiduciary duties, corporate waste and unjust enrichment that occurred between April 4, 2014 through January 4, 2018. Thereafter, the complaint largely summarized the allegations of the amended complaint filed in the securities class action described above. It does not quantify alleged damages. Ohr and the individuals dispute these claims and intend to defend the matter vigorously. Such litigation is currently stayed pursuant to a stipulation by the parties, which has been so ordered by the court, pending a decision in the Southern District case on the motion to dismiss, but that status could change. Management believes that the likelihood of an adverse decision from the ongoing litigation is unlikely; however, the litigation could result in substantial costs and a diversion of management’s resources and attention, which could harm Ohr’s business and the value of Ohr’s common stock.

Risks Related to the Ohr Reverse Stock Split

The Ohr Reverse Stock Split may not increase Ohr’s stock price over the long-term.

The principal purpose of the Ohr Reverse Stock Split is to increase the per-share market price of Ohr common stock above the minimum bid price requirement under the Nasdaq Listing Rules so that the listing of the combined company and the shares of Ohr common stock being issued in the merger will be approved for listing on Nasdaq. It cannot be assured, however, that the Ohr reverse Stock Split will accomplish this objective for any meaningful period of time. While it is expected that the reduction in the number of outstanding shares of common stock will proportionally increase the market price of Ohr common stock, it cannot be assured that the Ohr reverse Stock Split will increase the market price of its common stock by a multiple of the Ohr reverse Stock Split ratio chosen by its board of directors in its sole discretion, or result in any permanent or sustained increase in the market price of Ohr common stock, which is dependent upon many factors, including Ohr’s business and financial performance, general market conditions, and prospects for future success. Thus, while the stock price of the combined company might meet the continued listing requirements for Nasdaq, initially, it cannot be assured that it will continue to do so.

The Ohr Reverse Stock Split may decrease the liquidity of Ohr common stock.

Although the board of directors believes that the anticipated increase in the market price of Ohr common stock could encourage interest in its common stock and possibly promote greater liquidity for its stockholders, such liquidity could also be adversely affected by the reduced number of shares outstanding after the Ohr Reverse Stock Split. The reduction in the number of outstanding shares may lead to reduced trading and a smaller number of market makers for Ohr common stock.

The Ohr Reverse Stock Split may lead to a decrease in Ohr’s overall market capitalization.

Should the market price of Ohr common stock decline after the Ohr Reverse Stock Split, the percentage decline may be greater, due to the smaller number of shares outstanding, than it would have been prior to the Ohr Reverse Stock Split. A Reverse Stock Split is often viewed negatively by the market and, consequently, can lead to a decrease in Ohr’s overall market capitalization. If the per share market price does not increase in proportion to the Ohr Reverse Stock Split ratio, then the value of the combined company, as measured by its stock capitalization, will be reduced. In some cases, the per-share stock price of companies that have effected a reverse stock split subsequently declined back to pre-reverse split levels, and accordingly, it cannot be assured that the total market value of Ohr common stock will remain the same after the Ohr Reverse Stock Split is effected, or that the Ohr Reverse Stock Split will not have an adverse effect on Ohr’s stock price due to the reduced number of shares outstanding after the Ohr Reverse Stock Split.

Risks Related to Ohr

Risks Relating to Ohr’s Financial Position and Need for Capital

Ohr’s business was substantially dependent on the success of squalamine, which failed to meet its primary efficacy endpoint in the MAKO Study. Unless Ohr executes on a strategic alternative, Ohr may be required to liquidate, dissolve, or otherwise wind down its operations.

Until January 5, 2018, squalamine for the treatment of wet-AMD was Ohr’s lead product candidate. On January 5, 2018, Ohr announced topline results from its MAKO Study which did not meet its primary efficacy endpoint. Based on these results, Ohr has discontinued further development of squalimine and has been evaluating strategic alternatives to maximize stockholder value. Ohr has no assurance that it will be able to execute on a strategic alternative and may be required to liquidate, dissolve or otherwise wind down Ohr’s operations if Ohr is unable to do so. There is no assurance that the transaction with NeuBase will be consummated. (See Risk Factor entitled, “If the proposed merger with NeuBase is not consummated, Ohr’s business could suffer materially and Ohr’s stock price could decline.”)

Ohr may not be able to monetize any or some of the non-squalamine assets, including the SKS sustained release ocular drug delivery platform technology, the CEP assets, or Ohr’s interest in the Depymed joint venture.

Ohr may not be able to monetize any or some of the non-squalamine assets, including the SKS sustained release ocular drug delivery platform technology, the CEP assets, or Ohr’s interest in the Depymed joint venture. In that event, Ohr may be constrained to write off those assets, in whole or in part. At December 31, 2018, Ohr significantly wrote down the value of its SKS sustained release asset and there can be no assurance that Ohr will not be required to further write down or write off the asset entirely in the future.

Ohr is subject to securities class action litigation and derivative shareholder litigation. If an unfavorable ruling were to occur, there exists the possibility of a material adverse impact on Ohr.

As a result of Ohr’s announcement of negative results from the MAKO Study, Ohr’s stock price declined substantially. On February 14, 2018, plaintiff, Jeevesh Khanna, commenced an action in the Southern District of New York, against Ohr and several current and former officers, alleging that they violated federal securities laws between June 24, 2014 and January 4, 2018. On August 7, 2018, the lead plaintiffs, now George Lehman and Insured Benefit Plans, Inc. filed an amended complaint, stating the class period to be April 8, 2014 through January 4, 2018. The plaintiffs did not quantify any alleged damages in their complaint but, in addition to attorneys’ fees and costs, they seek to maintain the action as a class action and to recover damages on behalf of themselves and other persons who purchased or otherwise acquired Ohr common stock during the putative class period and purportedly suffered financial harm as a result. Ohr and the individuals dispute these claims and intend to defend the matter vigorously. On September 17, 2018, Ohr filed a motion to dismiss the complaint. On November 13, 2018, plaintiffs filed a motion to strike exhibits appended to the motion to dismiss. A decision on the motion to strike is pending, and the motion to dismiss will then be fully briefed based on a schedule to be determined by the court. This litigation could result in substantial costs and a diversion of management’s resources and attention, which could harm Ohr’s business and the value of the Ohr common stock.

On May 3, 2018, plaintiff Adele J. Barke, derivatively on behalf of Ohr, commenced an action against Michael Ferguson, Orin Hirschman, Thomas M. Riedhammer, June Almenoff and Jason Slakter in the Supreme Court, State of New York, alleging that the action was brought in the right and for the benefit of Ohr seeking to remedy their “breach of fiduciary duties, corporate waste and unjust enrichment that occurred between June 24, 2014 and the present.” It does not quantify any alleged damages. Ohr and the individuals dispute these claims and intend to defend the matter vigorously. Such litigation has been stayed pursuant to a stipulation by the parties, which has been so ordered by the court, pending a decision in the Southern District case on the motion to dismiss, but that status could change. This litigation could result in substantial costs and a diversion of management’s resources and attention, which could harm Ohr’s business and the value of the Ohr common stock.

In September 2018, plaintiff John Tomson, derivatively and on behalf of Ohr, commenced an action against Michael Ferguson, Sam Backenroth, Irach Taraporewala, Orin Hirschman, Thomas M. Riedhammer, June Almenoff and Jason Slakter in the U.S. District Court for the Southern District of New York alleging that the action was brought in the right and for the benefit of Ohr seeking to remedy their various breaches of fiduciary duties, corporate waste and unjust enrichment that occurred between April 4, 2014 through January 4, 2018. Thereafter, the complaint largely summarized the allegations of the amended complaint filed in the securities class action described above. It does not quantify alleged damages. Ohr and the individuals dispute these claims and intend to defend the matter vigorously. Such litigation is currently stayed pursuant to a stipulation by the parties, which has been so ordered by the court, pending a decision in the Southern District case on the motion to dismiss, but that status could change. Management believes that the likelihood of an adverse decision from the ongoing litigation is unlikely; however, the litigation could result in substantial costs and a diversion of management’s resources and attention, which could harm Ohr’s business and the value of Ohr’s common stock.

If Ohr fails to continue to meet all applicable Nasdaq requirements and Nasdaq determines to delist Ohr common stock, the delisting could adversely affect the market liquidity of Ohr common stock and the market price of Ohr common stock could decrease.

On February 20, 2018, Ohr received a written notice (the “First Notice”) from NASDAQ Stock Market LLC (“Nasdaq”) that Ohr had not been in compliance with the minimum bid price requirement set forth in Nasdaq Listing Rule 5550(a)(2) for a period of 30 consecutive business days. Nasdaq Listing Rule 5550(a)(2) requires listed securities to maintain a minimum closing bid price of $1.00 per share, and Nasdaq Listing Rule 5810(c)(3)(A) provides that a failure to meet the minimum closing bid price requirement exists if the deficiency continues for a period of 30 consecutive business days.

In accordance with Nasdaq’s Listing Rule 5810(c)(3)(A), Ohr had a period of 180 calendar days, or until August 20, 2018, to regain compliance with the minimum closing bid price requirement. Ohr did not regain compliance with the minimum closing bid price requirement by August 20, 2018. Ohr was notified by Nasdaq that it might be afforded a second 180 calendar period to regain compliance with the minimum closing bid price requirement under certain circumstances. As a result, Ohr applied for an extension of the cure period, as permitted under the notification. In order to cure the deficiency, Ohr indicated that, to that extent necessary, it planned to seek approval for a reverse stock split in order to meet the minimum closing bid price requirement at a special meeting of Ohr’s stockholders which Ohr would hold prior to the expiration of the second 180 day period and effectuate the reverse stock split immediately thereafter.

On August 21, 2018, Ohr received a written notice from Nasdaq that Ohr had been granted an additional 180 calendar days, or until February 19, 2019, to regain compliance with the minimum $1.00 bid price per share requirement of the Listing Rules of Nasdaq (“Second Notice”). According to the Second Notice, if at any time before February 19, 2019, the bid price of Ohr common stock closed at or above $1.00 per share for a minimum of 10 consecutive business days, Nasdaq would provide written notification that Ohr has achieved compliance with the minimum closing bid price requirement. If, however, compliance with the minimum closing bid price requirement cannot be demonstrated by February 19, 2019, Nasdaq will provide written notification that the Ohr common stock would be delisted. At that time, Ohr could appeal Nasdaq’s determination to a Hearings Panel.

On January 18, 2019, at a special meeting of Ohr’s stockholders, Ohr’s stockholders approved an amendment to Ohr’s certificate of incorporation to effect a reverse stock split of Ohr common stock at a split ratio of not less than one-for-three and not more than one-for-twenty, to be effective, if at all, at such time as the Ohr board of directors shall determine in its sole discretion. On January 18, 2019, following the Ohr special meeting, the Ohr board of directors approved a one-for-twenty reverse stock split of Ohr’s issued and outstanding shares of common stock. On January 22, 2019, Ohr filed with the Secretary of State of the State of Delaware a Certificate of Amendment to its Certificate of Incorporation to effect the reverse stock split. Ohr common stock began trading on a split-adjusted basis when the market opened on February 4, 2019. On February 20, 2019, Ohr received written confirmation from Nasdaq this it had regained compliance with Nasdaq listing requirements, and Nasdaq considers the matter closed. Although Ohr has regained compliance with the minimum $1.00 bid price requirement since Ohr common stock closed at $1.00 per share or more for a minimum of ten consecutive business days, there can be no assurance that Ohr will be able to maintain compliance with the requirements for listing Ohr common stock on Nasdaq. The failure to maintain Ohr’s listing on Nasdaq could have an adverse effect on the market price and liquidity of Ohr’s shares of common stock.

There is no certainty that Ohr will be able to execute on any strategic alternatives to maximize stockholder value. If Ohr is unable to execute such strategic alternatives, Ohr may be forced to cease operations and liquidate.

Based on the results of the MAKO study, Ohr began a comprehensive review of strategic alternatives to maximize stockholder value. As part of its review of strategic alternatives, Ohr formed a special committee of independent directors. The Ohr board of directors and the Ohr special committee retained Roth to advise and assist Ohr in this review. The strategic alternatives that Ohr was exploring included some or all of the following: license, divestiture, or monetization of current assets; license or acquisition of additional assets; merger, reverse merger, joint venture, partnership, or other business combination with another entity, public or private. There can be no assurance that this review process will result in a transaction, or that if a transaction does occur, that it will successfully enhance stockholder value. Ohr’s expected cash position, net of all liabilities, limits Ohr’s attractiveness to potential merger candidates and the value that Ohr may receive in such merger, joint venture, partnership, or other business combination scenarios may be less than the current market value of Ohr. If Ohr is unable to execute on this strategic or any other strategic alternative, Ohr may be forced to liquidate.

The process of exploring strategic alternatives could adversely impact Ohr’s business, financial condition and results of operations. Ohr could incur substantial expenses associated with identifying, evaluating, and executing on potential strategic alternatives, including those related to equity compensation, severance pay and insurance, legal, accounting and financial advisory fees. In addition, the process may be time consuming and disruptive to Ohr’s business operations, could divert the attention of management and the board of directors from Ohr’s business, could negatively impact Ohr’s ability to attract, retain and motivate key employees, and could expose Ohr to potential litigation in connection with this process or any resulting transaction. Further, speculation regarding any developments related to the review and execution of strategic alternatives and perceived uncertainties related to Ohr’s future could cause Ohr stock price to fluctuate significantly.

Ohr identified NeuBase as the right strategic partner based on its strategic plan. However, there is no assurance that the transaction with NeuBase will be consummated. See Risk Factor entitled, “If the proposed merger with NeuBase is not consummated, Ohr’s business could suffer materially and Ohr’s stock price could decline.”

Ohr has incurred significant losses and anticipate that Ohr will incur additional losses. Ohr might never achieve or sustain revenues .

Ohr has experienced significant net losses since its inception. As of December 31, 2018, Ohr had an accumulated deficit of approximately $122.2 million. Ohr expects to continue to incur net losses.

The report of Ohr’s independent registered public accounting firm expresses substantial doubt about Ohr’s ability to continue as a going concern. Such “going concern” opinion could impair Ohr’s ability to obtain financing.

Ohr’s auditors, MaloneBailey, LLP, have indicated in their report on Ohr’s financial statements for the fiscal year ended September 30, 2018 that conditions exist that raise substantial doubt about Ohr’s ability to continue as a going concern due to Ohr’s recurring losses from operations. A “going concern” opinion could impair Ohr’s ability to finance its operations through the sale of equity, incurring debt, or other financing alternatives. Ohr’s ability to continue as a going concern will depend upon the availability and terms of future funding. If Ohr is unable to achieve this goal, Ohr’s business would be jeopardized and Ohr may not be able to continue. If Ohr ceased operations, it is likely that all of Ohr’s investors would lose their investment.

Ohr depends upon key officers and consultants in a competitive market for skilled personnel. If Ohr is unable to retain key personnel, it could adversely affect its business. The negative result of the MAKO study and Ohr’s limited financial resources may make Ohr less successful at retaining employees.

Ohr is highly dependent upon the principal members of its management team, especially Ohr’s Chief Executive Officer, Dr. Jason Slakter, and Vice President of Business Development and Chief Financial Officer, Sam Backenroth, as well as Ohr’s directors and key consultants. A loss of any of these personnel may have a material adverse effect on aspects of Ohr’s business.

The announcement that Ohr has commenced a review of strategic alternatives may create uncertainty about Ohr’s prospects as an independent business entity and make it more difficult to retain qualified executive and other key personnel. The review process may also be costly, time-consuming, divert the attention of management or result in changes in Ohr’s management team or the Ohr board of directors, all of which could materially and adversely affect Ohr’s business. Ohr may be required to enter into retention agreements with its key employees to ensure execution of a strategic transaction, once such transaction is identified. In addition, Ohr’s stock price may experience periods of increased volatility as a result of these activities or related rumors and speculation.

Ohr identified NeuBase as the right strategic partner based on its strategic plan. However, there is no assurance that the transaction with NeuBase will be consummated. See Risk Factor entitled, “If the proposed merger with NeuBase is not consummated, Ohr’s business could suffer materially and Ohr’s stock price could decline.”

Risks Related to Ohr’s Business and Industry

Ohr currently does not have, and may never have, any products that generate revenues.

Ohr is a development stage pharmaceutical company and currently does not have, and may never have, any products that generate revenues. Investment in pharmaceutical product development is highly speculative because it entails substantial upfront capital expenditures and significant risk that any potential product candidate will fail to demonstrate adequate effect or an acceptable safety profile, gain regulatory approval and become commercially viable. To date, Ohr has not generated any product revenues.

Ohr is highly dependent upon its ability to raise additional capital. Raising additional capital may cause dilution to Ohr’s stockholders, restrict Ohr’s operations or require it to relinquish rights to its technologies.

Until such time, if ever, as Ohr can generate substantial product revenues, Ohr may finance its cash needs through a combination of equity offerings, debt financings, and partnerships. Ohr does not have any committed external source of funds. To the extent that Ohr raises additional capital through the sale of equity or convertible debt securities, Ohr’s stockholders’ ownership interest will be diluted, and the terms of these securities may include liquidation or other preferences that adversely affect Ohr’s stockholders’ rights as holders of Ohr common stock. Debt financing and preferred equity financing, if available, may involve agreements that include covenants limiting or restricting Ohr’s ability to take specific actions.

If Ohr raises capital through a partnership, Ohr may have to relinquish rights to its technologies or grant licenses on terms that may not be favorable to Ohr. If Ohr is unable to raise additional funds through equity or debt financings when needed, Ohr may be required to cease operations and liquidate.

Ohr is highly dependent upon its ability to enter into agreements with collaborative partners to develop, commercialize, and market any products.

Ohr is dependent on strategic partnerships to develop technologies and products. To date, Ohr has not entered into any strategic partnerships for any products. Ohr faces significant competition in seeking appropriate strategic partners, and these strategic partnerships can be intricate and time consuming to negotiate and document. Ohr may not be able to negotiate strategic partnerships on acceptable terms, or at all. Ohr is unable to predict when, if ever, Ohr will enter into any strategic partnerships because of the numerous risks and uncertainties associated with establishing strategic partnerships.

While Ohr’s strategy is to partner with an appropriate party, no assurance can be given that any third party would be interested in partnering with Ohr. Ohr currently lacks the resources to conduct clinical trials, to manufacture any product candidates on a large scale, and Ohr has no sales, marketing or distribution capabilities. In the event Ohr is not able to enter into a collaborative agreement with a partner or partners, on commercially reasonable terms, or at all, Ohr may be unable to conduct clinical trials, or to develop products which would have a material adverse effect upon Ohr’s business, prospects, financial condition, and results of operations.

Even if Ohr succeeds in securing a partner, the partner collaborators may fail to develop or effectively commercialize products using Ohr’s technologies. Such partnership would pose a number of risks, including the following:

Thus, should Ohr ever be successful in entering into a partnership agreement, the agreements may not lead to development or commercialization of product candidates in the most efficient manner or at all. Partnership agreements are generally terminable without cause on short notice. Ohr also face competition in seeking out collaborators. If Ohr is unable to secure new partners that achieve the partner’s objectives and meet Ohr’s expectations, Ohr may be unable to advance any product candidates and may not generate meaningful revenues.

Ohr has no experience selling, marketing or distributing products and no internal capability to do so.

Ohr currently has no sales, marketing or distribution capabilities and no experience in building a sales force and distribution capabilities. If Ohr is ever in a position to commercialize any products, of which there can be no assurance, Ohr must develop internal sales, marketing and distribution capabilities, which will be expensive and time consuming, or make arrangements with third parties to perform these services. If Ohr decides to market any products directly, Ohr must commit significant financial and managerial resources to develop a marketing and sales force with technical expertise and with supporting distribution capabilities. Building an in-house marketing and sales force with technical expertise and distribution capabilities will require significant expenditures, management resources and time. Factors that may inhibit Ohr’s efforts to commercialize any products directly and without strategic partners include:

Ohr may not be successful in recruiting the sales and marketing personnel necessary to sell any products and even if Ohr does build a sales force, they may not be successful in marketing any products, which would have a material adverse effect on Ohr’s business and results of operations.

If Ohr is ever to conduct additional clinical trials, Ohr would continue to rely on third parties to conduct any such trials for Ohr. If such third parties do not successfully carry out their duties or if Ohr loses its relationships with such third parties, Ohr’s drug development efforts could be delayed.

Ohr is dependent on contract research organizations, third-party vendors and independent investigators for preclinical testing, and clinical trials related to any potential drug discovery and development efforts. These parties are not Ohr’s employees, and Ohr cannot control the amount or timing of resources that they devote to any programs. If they fail to devote sufficient time and resources to any drug development programs or if their performance is substandard, it would delay the development and commercialization of these product candidates. The parties with which Ohr would contract for execution of its clinical trials would play a significant role in the conduct of the trials and the subsequent collection and analysis of data. Their failure to achieve their research goals or otherwise meet their obligations on a timely basis could adversely affect clinical development of these product candidates.

Communicating with outside parties can also be challenging, potentially leading to mistakes as well as difficulties in coordinating activities. Outside parties may:

These factors may materially adversely affect the willingness or ability of third parties to conduct any clinical trials and may lead to unexpected cost increases. Nevertheless, Ohr is responsible for ensuring that each of Ohr’s studies would be conducted in accordance with the applicable protocol, legal, regulatory and scientific standards, and Ohr’s reliance on contract research organizations would not relieve Ohr of its regulatory responsibilities. Ohr and its contract research organizations would be required to comply with applicable current Good Laboratory Practice (“CGLP”), current Good Manufacturing Practice (“CGMP”), and current Good Clinical Practice (“CGCP”) regulations and guidelines enforced by the FDA and comparable foreign regulatory authorities for any products in clinical development. The FDA enforces these CGCP regulations through periodic inspections of clinical trial sponsors, principal investigators and trial sites. If Ohr or its contract research organizations fail to comply with applicable CGCP, the clinical data generated in these clinical trials might be deemed unreliable and the FDA or comparable foreign regulatory authorities may require additional clinical trials before approving the marketing applications. Ohr cannot assure that, upon inspection, the FDA or any comparable foreign regulatory authority will determine that any clinical trials would comply with CGCP. In addition, clinical trials must be conducted with product produced under CGMP regulations and would require a large number of test subjects. Ohr’s failure or the failure of its contract research organizations to comply with these regulations might require Ohr to repeat clinical trials, which would delay the regulatory approval process and could also subject Ohr to enforcement action up to and including civil and criminal penalties.

If Ohr is ever to conduct any additional trials and its contract research organizations do not successfully carry out their duties or if Ohr was to lose relationships with contract research organizations, any drug development efforts could be delayed or terminated.

If Ohr was to lose relationships with any one or more of these parties, Ohr could experience a significant delay in both identifying another comparable provider and then contracting for its services. Ohr may be unable to retain an alternative provider on reasonable terms, if at all. Even if Ohr locates an alternative provider, it is likely that this provider might need additional time to respond to Ohr’s needs and might not provide the same type or level of service as the original provider. In addition, any provider that Ohr retains would be subject to CGLP and CGCP, other regulatory standards, and similar foreign standards, and Ohr does not have control over compliance with these regulations by these providers. Consequently, if these practices and standards are not adhered to by these providers, the development and commercialization of any products could be delayed, and have a material adverse effect on Ohr’s business.

Ohr may not be able to continue or fully exploit its relationships with outside advisors, which could impair Ohr’s business.

Ohr works with advisors who are experts in their respective fields. They advise Ohr with respect to its business and operations. These advisors are not Ohr’s employees and may have other commitments that would limit their future availability to Ohr. If a conflict of interest arises between their work for Ohr and their work for another entity, Ohr may lose their services, which may impair its reputation in the industry and its business efforts.

Ohr has no manufacturing capabilities, and, if needed, would rely completely on third-party manufacturers, which might result in delays in research, development, clinical trials, regulatory approvals and product introductions.

Ohr has no manufacturing facilities and does not have extensive experience in the manufacturing of drugs or in designing drug manufacturing processes. Ohr would have to contract with third-party manufacturers to produce, in collaboration with Ohr, any products for clinical trials. Ohr’s reliance on these third parties for development activities would reduce Ohr’s control over these activities but would not relieve Ohr of its responsibility to ensure compliance with all required regulations and study and trial protocols. If these third parties were not to successfully carry out their contractual duties, meet expected deadlines or conduct studies in accordance with regulatory requirements or Ohr’s stated study and trial plans and protocols, or if there were disagreements between Ohr and these third parties, Ohr would not be able to initiate, or complete, or may be delayed in completing, the clinical trials required to support future approval of any products. In some such cases, Ohr might need to locate an appropriate replacement third-party relationship, which may not be readily available or with acceptable terms, which would cause additional delay with respect to the approval of products and would thereby have a material adverse effect on Ohr’s business, financial condition, results of operations and prospects.

Contract manufacturers are subject to significant regulatory oversight with respect to manufacturing products. The manufacturing facilities on which Ohr would need to rely may not continue to meet regulatory requirements and may have limited capacity.

Any manufacturers of product candidates are obliged to operate in accordance with FDA-mandated CGMPs. In addition, the facilities that would be used by contract manufacturers or other third party manufacturers to manufacture product candidates must be approved by the FDA or other foreign regulatory authority pursuant to inspections that would be conducted after Ohr requests regulatory approval from the FDA or other foreign regulatory authority. A failure of any contract manufacturers to establish and follow CGMPs and to document their adherence to such practices may lead to significant delays in development, or in clinical trials or in obtaining regulatory approval of product candidates or the ultimate launch of products into the market. Furthermore, any contract manufacturers are likely to be engaged with other companies to supply and/or manufacture materials or products for such companies, which exposes them to regulatory risks for the production of such materials and products. As a result, failure to satisfy the regulatory requirements for the production of those materials and products may affect the regulatory clearance of the contract manufacturers’ facilities generally. Failure by third-party manufacturers or Ohr to comply with applicable regulations could result in sanctions being imposed on Ohr, including fines, injunctions, civil penalties, failure of the government to grant pre-market approval of drugs, delays, suspension or withdrawal of approvals, seizures or recalls of products, operating restrictions, and criminal prosecutions. Many aspects of the clinical trial and manufacturing process are outside of Ohr’s control. The facilities and quality systems of third-party contractors must pass a pre-approval inspection for compliance with the applicable regulations as a condition of regulatory approval of product candidates. In addition, the regulatory authorities may, at any time, audit or inspect a manufacturing facility involved with the preparation of product candidates or the associated quality systems for compliance with the regulations applicable to the activities being conducted. If these facilities do not pass a pre-approval plant inspection, FDA approval of the products will not be granted.

The regulatory authorities also may, at any time following approval of a product for sale, audit Ohr’s manufacturing facilities or those of third-party manufacturers. If any such inspection or audit identifies a failure to comply with applicable regulations or if a violation of product specifications or applicable regulations occurs independent of such an inspection or audit, Ohr or the relevant regulatory authority may require remedial measures that may be costly and/or time-consuming for Ohr or third-party manufacturers to implement and that may include the temporary or permanent suspension of a clinical trial or commercial sales or the temporary or permanent closure of a manufacturing facility. Any such remedial measures imposed upon Ohr or third parties with whom Ohr might contract could materially harm Ohr’s business.

Developments by competitors may render Ohr’s technologies obsolete or non-competitive which would have a material adverse effect on Ohr’s business and results of operations.

Any drug candidates would have to compete with existing therapies and therapies under development by competitors. In addition, the commercial opportunities may be reduced or eliminated if competitors develop and market products that are less expensive, more effective or safer. Even if Ohr is successful in developing effective drugs, they may not compete successfully with products produced by Ohr’s competitors. Most of Ohr’s competitors, either alone or together with their collaborative partners, operate larger research and development programs, have larger staffing and facilities, and have substantially greater financial resources than Ohr does, as well as significantly greater experience in:

These organizations also compete with Ohr for mergers, acquisitions and joint venture candidates and for other collaborations.

Ohr’s employees, partners, independent contractors, consultants, and vendors may engage in misconduct or other improper activities, including noncompliance with regulatory standards and requirements.

Ohr is exposed to the risk that its employees, partners, independent contractors, consultants, and vendors may engage in fraudulent or other illegal activity with respect to Ohr’s business. Such misconduct could include intentional, reckless and/or negligent conduct or unauthorized activity that violates: (1) FDA or any comparable foreign regulatory authority regulations, including those laws requiring the reporting of true, complete and accurate information to the FDA or any comparable foreign regulatory authority; (2) manufacturing standards; (3) federal, state and foreign healthcare fraud and abuse laws and regulations; or (4) laws that require the true, complete and accurate reporting of financial information or data. Activities subject to these laws also involve the improper use of information obtained in the course of clinical trials, or illegal misappropriation of drug product, which could result in regulatory sanctions and serious harm to Ohr’s reputation. Any incidents or any other conduct that leads to an employee receiving an FDA or other regulatory authority debarment could result in a loss of business from Ohr’s partners and severe reputational harm. Ohr has adopted a Code of Business Conduct and Ethics, but it is not always possible to identify and deter misconduct, and the precautions Ohr takes to detect and prevent this activity may not be effective in controlling unknown or unmanaged risks or losses or in protecting Ohr from governmental investigations or other actions or lawsuits stemming from a failure to be in compliance with such laws or regulations. If any such actions are instituted against Ohr, and Ohr is not successful in defending itself or asserting Ohr’s rights, those actions could have a significant impact on Ohr’s business, including the imposition of civil, criminal and administrative penalties, damages, monetary fines, contractual damages, reputational harm, diminished profits and future earnings, and curtailment of Ohr’s operations, any of which could adversely affect Ohr’s ability to operate its business, operating results and financial condition.

Security breaches and other disruptions could compromise Ohr’s information and expose Ohr to liability, which would cause Ohr’s business and reputation to suffer.

Ohr stores sensitive data, including intellectual property, its proprietary business information and personally identifiable information of its employees, in its data centers and on its networks. The secure maintenance of this information is critical to Ohr’s operations. Despite Ohr’s security measures, Ohr’s information technology and infrastructure may be vulnerable to attacks by hackers or breached due to employee error, malfeasance or other disruptions. Any such breach could compromise Ohr’s networks and the information stored there could be accessed, publicly disclosed, lost or stolen. Any such access, disclosure or other loss of information could result in legal claims or proceedings, liability under laws that protect the privacy of personal information, regulatory penalties, and damage Ohr’s reputation.

Ohr’s business and operations would suffer in the event of system failures.

Despite the implementation of security measures, Ohr’s internal computer systems and those of its contractors and consultants are vulnerable to damage from computer viruses, unauthorized access, natural disasters, terrorism, war and telecommunication and electrical failures. Such an event could cause interruption of Ohr’s operations. To the extent that any disruption or security breach were to result in a loss of or damage to Ohr’s data, or inappropriate disclosure of confidential or proprietary information, Ohr could incur liability and the development of product candidates could be delayed.

Risks Related to FDA, Comparable Foreign Regulatory Authority and Healthcare Regulations.

Pharmaceutical companies face heavy government regulation. FDA regulatory approval and/or comparable foreign regulatory authority’s approval of any products is uncertain.

The research, testing, manufacturing and marketing of drug products are subject to extensive regulation by federal, state and local government authorities, including the FDA or any comparable foreign regulatory authority. To obtain regulatory approval of a product, one must demonstrate to the satisfaction of the applicable regulatory agency that, among other things, the product is safe and effective for its intended use. In addition, one must show that the manufacturing facilities used to produce the products are in compliance with CGMP regulations.

The process of obtaining FDA and other required regulatory approvals, including foreign regulatory approvals and clearances, would require a substantial amount of time and significant capital expenditure. Despite the time and expense expended, regulatory approval is never guaranteed. The number of preclinical and clinical trials that would be required for FDA approval, or any comparable foreign regulatory authority’s approval, varies depending on the drug candidate, the disease or condition for which the drug candidate is in development, and the requirements applicable to that particular drug candidate. The FDA or other foreign health authority can delay, limit or deny approval of a drug candidate for many reasons, including that:

If and when products do obtain marketing approval, the marketing, distribution and manufacture of such products would remain subject to extensive ongoing regulatory requirements. Failure to comply with applicable regulatory requirements could result in:

Ohr has not received regulatory approval to market any product candidates in any jurisdiction.

Following regulatory approval of any drug products, ongoing regulatory obligations and restrictions might result in significant expense and limit the ability to commercialize any products.

With regard to drug candidates, if any, approved by the FDA or by another regulatory authority, including a foreign regulatory authority, Ohr would be held to extensive regulatory requirements over product manufacturing, labeling, packaging, adverse event reporting, storage, advertising, promotion and record keeping. Regulatory approvals may also be subject to significant limitations on the indicated uses or marketing of the drug candidates. Potentially costly follow-up or post-marketing clinical studies may be required as a condition of approval to further substantiate safety or efficacy, or to investigate specific issues of interest to the regulatory authority. Previously unknown problems with the drug candidate, including adverse events of unanticipated severity or frequency, may result in restrictions on the marketing of the drug, and could include withdrawal of the drug from the market.

In addition, the law or regulatory policies governing pharmaceuticals may change. Ohr cannot predict the likelihood, nature or extent of adverse government regulation that may arise from future legislation or administrative action, either in the United States or elsewhere. If Ohr was able to maintain regulatory compliance, Ohr might not be permitted to market any drugs, which could have a material adverse effect on Ohr’s business and competitive position.

Healthcare policy changes, including proposals to reform the U.S. healthcare system, may harm Ohr’s future business.

Healthcare costs have risen significantly over the past decade. There have been and continue to be proposals by legislators, regulators and third-party payors to keep these costs down. Certain proposals, if passed, would impose limitations on the prices Ohr would be able to charge for products, or the amounts of reimbursement available for these products from governmental agencies and third party payors. These limitations could in turn reduce the amount of investment into development, and the amount of revenues that Ohr would be able to generate in the future from sales of products and licenses of Ohr’s technology.

The Patient Protection and Affordable Care Act, as amended by the Healthcare and Education Reconciliation Act of 2010, together, the Healthcare Reform Act, is a sweeping measure intended to expand healthcare coverage within the U.S., primarily through the imposition of health insurance mandates on employers and individuals, the provision of subsidies to eligible individuals enrolled in plans offered on the health insurance exchanges, and the expansion of the Medicaid program. This law has substantially changed the way healthcare is financed by both governmental and private insurers, and significantly impacts the pharmaceutical industry. In addition, the Healthcare Reform Act imposes an annual fee, which will increase annually, on sales by branded pharmaceutical manufacturers starting in 2011. The financial impact of these discounts, increased rebates and fees and the other provisions of the legislation on Ohr’s business is unclear and there can be no assurance that Ohr’s business will not be materially adversely affected. In addition, these and other ongoing initiatives in the United States have increased and will continue to increase pressure on drug pricing. The announcement or adoption of any government initiatives could have an adverse effect on potential revenues from any product that Ohr may successfully develop.

Moreover, additional legislative or regulatory changes remain possible and appear likely. In this regard, the U.S. Tax Cuts and Jobs Act of 2017, or U.S. Tax Act, signed into law in December 2017, includes a provision repealing, effective January 1, 2019, the tax-based shared responsibility payment imposed by the Healthcare Reform Act on certain individuals who fail to maintain qualifying health coverage for all or part of a year that is commonly referred to as the “individual mandate.” The nature and extent of any additional legislative or regulatory changes to the Healthcare Reform Act are uncertain at this time. Ohr expects that the Healthcare Reform Act, as currently enacted or as it may be amended in the future, and other healthcare reform measures that may be adopted in the future could have a material adverse effect on Ohr’s industry generally. In addition to the Healthcare Reform Act, there will continue to be proposals by legislators at both the federal and state levels, regulators and third party payors to keep healthcare costs down while expanding individual healthcare benefits.

Various healthcare reform proposals have also emerged at the state level. Ohr cannot predict what healthcare initiatives, if any, will be implemented at the federal or state level, or the effect any future legislation or regulation will have on Ohr. However, an expansion in government’s role in the U.S. healthcare industry may lower the revenues for future products and adversely affect Ohr’s future business, possibly materially.

Risks Related to Ohr’s Intellectual Property

Ohr’s ability to compete may be undermined if Ohr does not adequately protect its proprietary rights.

Ohr’s commercial success depends on obtaining and maintaining proprietary rights to product candidates and technologies and their uses, as well as successfully defending these rights against third-party challenges. Ohr will be able to most effectively protect product candidates, technologies, and their uses from unauthorized use by third parties to the extent that valid and enforceable patents, or effectively protected trade secrets, cover them. Nonetheless, the issued patents and patent applications covering Ohr’s technologies remain subject to uncertainty due to a number of factors, including: