RISK FACTORS

The combined company will be faced with a market environment that cannot be predicted and that involves significant risks, many of which will be beyond its control. In addition to the other information contained in this proxy statement/prospectus/information statement, you should carefully consider the material risks described below before deciding how to vote your shares of stock. In addition, you should read and consider the risks associated with the business of OncoGenex because these risks may also affect the combined company. These risks can be found in OncoGenex’s Annual Report on Form 10-K, as updated by subsequent Quarterly Reports on Form 10-Q, all of which are filed with the SEC. You should also read and consider the other information in this proxy statement/prospectus/information statement and the other documents incorporated by reference into this proxy statement/prospectus/information statement. Please see the section entitled “Where You Can Find More Information.”

Risks Related to the Merger

The exchange ratio is not adjustable based on the market price of OncoGenex 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 Achieve common stock, and the exchange ratio is only adjustable upward or downward based on increases or decreases in the number of shares of Achieve’s issued and outstanding capital stock and the number of shares of Achieve capital stock issuable upon the exercise of all issued and outstanding equity awards, the number of OncoGenex’s issued and outstanding common stock, the payment of cash in lieu of fractional shares and the proposed reverse stock split, prior to completion of the merger as described in “The Merger—Merger Consideration.” The pre-split exchange ratio is 4,242.8904, and the post-split exchange ratio will depend on the exact reverse stock split ratio that is ultimately determined by the OncoGenex board of directors in consultation with the Achieve board of directors and certain changes in the capitalization of the two companies. Any changes in the market price of OncoGenex common stock before the completion of the first merger will not affect the number of shares Achieve stockholders will be entitled to receive pursuant to the Merger Agreement. Therefore, if before the completion of the first merger the market price of OncoGenex common stock declines from the market price on the date of the Merger Agreement, then Achieve stockholders could receive merger consideration with substantially lower value. Similarly, if before the completion of the first merger the market price of OncoGenex common stock increases from the market price on the date of the Merger Agreement, then Achieve stockholders could receive merger consideration with substantially more value for their shares of Achieve 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 OncoGenex common stock, for each one percentage point that the market value of OncoGenex 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 Achieve stockholders.

Failure to complete the merger may result in OncoGenex and Achieve paying a termination fee or expenses to the other party and could harm the common stock price of OncoGenex and future business and operations of each company.

If the merger is not completed, OncoGenex and Achieve are subject to the following risks:

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In addition, if the Merger Agreement is terminated and the board of directors of OncoGenex or Achieve determines to seek another business combination, there can be no assurance that either OncoGenex or Achieve will be able to find a partner willing to provide equivalent or more attractive consideration than the consideration to be provided by each party in the merger.

If the conditions to the first merger are not met, the merger may not occur.

Even if the merger is approved by the stockholders of OncoGenex and Achieve, specified conditions must be satisfied or waived to complete the merger. These conditions are set forth in the Merger Agreement and described in the section entitled “The Merger Agreement—Conditions to the Completion of the Merger.” OncoGenex and Achieve cannot assure you that all of the conditions will be satisfied or waived. If the conditions are not satisfied or waived, the merger may not occur or will be delayed, and OncoGenex and Achieve each may lose some or all of the intended benefits of the merger.

The merger may be completed even though material adverse changes may result from the announcement of the merger, industry-wide changes and other causes.

In general, either OncoGenex or Achieve can refuse to complete the merger if there is a material adverse change affecting the other party between January 5, 2017, the date of the Merger Agreement, and the closing. However, certain types of changes do not permit either party to refuse to complete the merger, even if such change could be said to have a material adverse effect on OncoGenex or Achieve, including:

If adverse changes occur and OncoGenex and Achieve still complete the merger, the combined company stock price may suffer. This in turn may reduce the value of the merger to the stockholders of OncoGenex, Achieve or both.

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The combined company will need to raise additional capital by issuing securities or debt or through licensing arrangements, which may cause dilution to the combined company’s stockholders or restrict the combined company’s operations or proprietary rights.

The combined company may be required to raise additional funds sooner than currently planned. Additional financing may not be available to the combined company when it needs it or may not be available on favorable terms. To the extent that the combined company raises additional capital by issuing equity securities, such an issuance may cause significant dilution to the combined company’s stockholders’ ownership and the terms of any new equity securities may have preferences over the combined company’s common stock. Any debt financing the combined company enters into may involve covenants that restrict its operations. These restrictive covenants may include limitations on additional borrowing and specific restrictions on the use of the combined company’s assets, as well as prohibitions on its ability to create liens, pay dividends, redeem its stock or make investments. In addition, if the combined company raises additional funds through licensing arrangements, it may be necessary to grant licenses on terms that are not favorable to the combined company.

Some OncoGenex and Achieve executive officers and directors have interests in the merger that are different from yours and that may influence them to support or approve the merger without regard to your interests.

Certain officers and directors of OncoGenex and Achieve participate in arrangements that provide them with interests in the merger that are different from yours, including, among others, the continued service as an officer or director of the combined company, severance and retention benefits, the acceleration of stock option and/or restricted stock unit vesting, continued indemnification and the potential ability to sell an increased number of shares of common stock of the combined company in accordance with Rule 144 under the Securities Act of 1933, as amended, or the Securities Act.

For example, Scott Cormack, OncoGenex’s Chief Executive Officer, will no longer serve as Chief Executive Officer upon the consummation of the merger. Consistent with the terms of Mr. Cormack’s existing employment agreement and equity award agreements, upon the termination of Mr. Cormack’s employment, assuming such termination occurred on March 22, 2017, he will receive benefits having an aggregate value of approximately $1.3 million, comprised of approximately $1.2 million in cash and approximately $0.1 million received upon the acceleration of outstanding equity and in connection with other benefits. Additionally, certain executive officers and directors of OncoGenex will continue in their current roles at the combined company. For more information concerning the treatment of OncoGenex options in connection with the merger, see the section entitled “The Merger Agreement—Treatment of OncoGenex Stock Options and Warrants.”

For example, some of Achieve’s directors and executive officers are expected to become directors and executive officers of the combined company upon the closing of the merger while other Achieve directors and executive officers will not have roles in the combined company. Specifically, Richard Stewart and Dr. Anthony Clarke, both of whom are currently executive officers of and consultants to Achieve, are expected to become executive officers of the combined company upon the closing of the merger, with Mr. Stewart serving as the Chief Executive Officer and Dr. Clarke serving as the Chief Scientific Officer of the combined company. Additionally, Mr. Stewart and Dr. Clarke, both of whom are current directors of Achieve, will be designated to serve on the board of directors of the combined company following the closing of the merger. Ronald Martell, the former Chief Executive Officer of Achieve and a director of Achieve, will not continue as the Chief Executive Officer of the combined company or as a director of the combined company and Mr. Martell will not continue to serve in any capacity with the combined company. Caroline Loewy, the former Chief Financial Officer of Achieve, will not continue as the Chief Financial Officer of the combined company and Ms. Loewy will not continue to serve in other capacity with the combined company. Mr. Martell and Ms. Loewy are expected to receive certain payments in connection with their separation, which have not yet been determined.

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The market price of the combined company’s common stock following the merger 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 if:

The CVRs may not result in any cash or other payments to holders of CVRs.

Although OncoGenex currently plans to enter into the CVR agreement and issue CVRs to existing holders of OncoGenex common stock, if OncoGenex and Achieve agree, the terms of the CVR agreement as currently contemplated may be changed prior to OncoGenex entering into the CVR agreement and, consequently, there is no assurance that the CVRs will be issued at all or based on the terms currently set forth in the form of the CVR agreement. For more information regarding the CVRs, see the section entitled “Agreements Related to the Merger—CVR Agreement.”

Additionally, OncoGenex and the combined company must identify and enter into a binding term sheet with a third party relating to the third party’s development and potential commercialization of apatorsen by August 17, 2017 for the CVRs to have any value. OncoGenex and the combined company may be unable to identify and enter into an agreement with a third party to develop and potentially commercialize apatorsen by August 17, 2017, and if it does, the third party may not meet the requisite development milestones under the CVR agreement and CVR holders may never receive any value from the CVRs. If CVRs are issued, they will not be certificated or transferable and may not result in any cash payments to holders of CVRs. Under the CVR agreement, the combined company will have limited obligations to pursue, engage in, negotiate, enter into or consummate an actual or potential partnering agreement with respect to apatorsen. If any payment is made on the CVRs, it will not be made until the achievement of a milestone. Because the amount of any payment on the CVRs will not be able to be determined at the effective time of the merger, and may not be determined for a significant period of time thereafter, it may be difficult to value the CVRs.

The tax treatment of the CVRs is uncertain.

In the opinion of Fenwick and West LLP, OncoGenex’s legal counsel, the distribution and issuance of CVRs to common stockholders of OncoGenex prior to completion of the first merger and under the terms expressed in the form of the CVR agreement attached as Annex F to this proxy statement/prospectus/information statement is more likely than not to be treated as a distribution of property with respect to OncoGenex common stock under the Code. However, there is no authority directly on point addressing the U.S. federal income tax treatment of contingent value rights with characteristics similar to the CVRs. Therefore, it is possible that the distribution and issuance of the CVRs may be treated as a distribution of equity with respect to its stock, an “open transaction,” or as a “debt instrument” for U.S. federal income tax purposes, and such questions are inherently factual in nature. For more information regarding the U.S. federal income tax consequences of the CVRs, see the section entitled “Agreements Related to the Merger—CRV Agreement—Tax Treatment of CVRs.”

OncoGenex and Achieve 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 full strategic and financial benefits currently anticipated from the merger, OncoGenex and Achieve stockholders will have experienced substantial dilution of their ownership

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interests in their respective companies without receiving any commensurate benefit, or only receiving part of the commensurate benefit to the extent the combined company is able to realize only part of the strategic and financial benefits currently anticipated from the merger.

During the pendency of the merger, OncoGenex and Achieve may not be able to enter into a business combination with another party at a favorable price because of restrictions in the Merger Agreement, which could adversely affect their respective businesses.

Covenants in the Merger Agreement impede the ability of OncoGenex and Achieve to make acquisitions, subject to certain exceptions relating to fiduciary duties, or complete other transactions that are not in the ordinary course of business pending completion of the first merger. As a result, if the first merger is not completed, the parties may be at a disadvantage to their competitors during that period. In addition, while the Merger Agreement is in effect, each party is generally prohibited from soliciting, initiating, encouraging or entering into certain extraordinary transactions, such as a merger, sale of assets or other business combination outside the ordinary course of business, with any third party, subject to certain exceptions. Any such transactions could be favorable to such party’s stockholders.

Certain provisions of the Merger Agreement may discourage third parties from submitting alternative takeover proposals, including proposals that may be superior to the arrangements contemplated by the Merger Agreement.

The terms of the Merger Agreement prohibit each of OncoGenex and Achieve from soliciting alternative takeover proposals or cooperating with persons making unsolicited takeover proposals, except in certain circumstances when such party’s board of directors determines in good faith, after consultation with its financial advisor and outside legal counsel, that an unsolicited alternative takeover proposal constitutes or is reasonably likely to result in a superior takeover proposal. In addition, if OncoGenex or Achieve terminate the Merger Agreement under certain circumstances, including terminating because of a decision of a board of directors to recommend an alternative proposal, OncoGenex or Achieve would be required to pay a termination fee of $0.5 million to the other party. If OncoGenex or Achieve is in breach of certain of the no solicitation obligations of the Merger Agreement, OncoGenex or Achieve, as applicable, will be required to pay the other party a termination fee of $1.0 million. In addition, in some circumstances, OncoGenex and Achieve are required to reimburse the other party for expenses incurred in connection with the merger, up to a maximum of $0.5 million. These termination fees and reimbursement obligations may discourage third parties from submitting alternative takeover proposals to OncoGenex or Achieve or their stockholders, and may cause the respective boards of directors to be less inclined to recommend an alternative proposal.

Because the lack of a public market for Achieve shares makes it difficult to evaluate the fairness of the merger, the stockholders of Achieve may receive consideration in the first merger that is less than the fair market value of the Achieve shares and/or OncoGenex may pay more than the fair market value of the Achieve shares.

The outstanding capital stock of Achieve is privately held and is not traded in any public market. The lack of a public market makes it extremely difficult to determine the fair market value of Achieve. Because the percentage of OncoGenex equity to be issued to Achieve stockholders was determined based on negotiations between the parties, it is possible that the value of the OncoGenex common stock to be received by Achieve stockholders will be less than the fair market value of Achieve, or OncoGenex may pay more than the aggregate fair market value for Achieve.

Risks Related to OncoGenex

Investing in OncoGenex common stock involves a high degree of risk. You should consider carefully the risks and uncertainties described below, together with all of the other information contained in this proxy statement/

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prospectus/information statement and in the other periodic and current reports and other documents it files with the Securities and Exchange Commission, before deciding to invest in its common stock. If any of the following risks materialize, OncoGenex’s business, financial condition, results of operation and future prospects will likely be materially and adversely affected. In that event, the market price of its common stock could decline and you could lose all or part of your investment.

OncoGenex Risks Related to the Merger

There is no assurance that the proposed merger between OncoGenex and Achieve will be completed in a timely manner or at all. If the merger with Achieve is not consummated, OncoGenex’s business could suffer materially and its stock price could decline.

The consummation of the proposed merger between OncoGenex and Achieve is subject to a number of closing conditions, including the approval by the stockholders of both OncoGenex and Achieve and other customary closing conditions. The parties are targeting a closing of the transaction in mid-2017. However, there can be no assurance that the proposed merger will be consummated on the desired timeframe, or at all.

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

If the merger is not completed, the board of directors of OncoGenex may decide to pursue a dissolution and liquidation of the company. In such an event, the amount of cash available for distribution to its stockholders will depend heavily on the timing of such liquidation as well as the amount of cash that will need to be reserved for commitments and contingent liabilities.

There can be no assurance that the merger will be completed. If the merger is not completed, the board of directors of OncoGenex may decide to pursue a dissolution and liquidation of the company. In such an event, the amount of cash available for distribution to its stockholders will depend heavily on the timing of such decision, as with the passage of time the amount of cash available for distribution will be reduced as it continues to fund its operations. In addition, if its board of directors was to approve and recommend, and its stockholders were to approve, a dissolution and liquidation of the company, OncoGenex would be required under Delaware corporate law to pay out outstanding obligations, as well as to make reasonable provision for contingent and unknown obligations, prior to making any distributions in liquidation to its stockholders. OncoGenex’s commitments and contingent liabilities may include severance obligations, regulatory and clinical obligations remaining under its clinical trials, fees and expenses related to the merger and non-cancelable lease obligations. As a result of this requirement, a portion of its assets may need to be reserved pending the resolution of such obligations. In addition, OncoGenex may be subject to litigation or other claims related to a dissolution and liquidation. If a dissolution and liquidation were pursued, its board of directors, in consultation with its advisors, would need to evaluate these matters and make a determination about a reasonable amount to reserve. Accordingly, holders of its common stock could lose all or a significant portion of their investment in the event of a liquidation, dissolution or winding up of OncoGenex.

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The issuance of shares of OncoGenex common stock to Achieve stockholders in the pending merger will dilute substantially the voting power of OncoGenex’s current stockholders.

If the pending merger is completed, each outstanding share of Achieve common stock will be converted into the right to receive approximately 4,242.8904 shares of OncoGenex common stock, subject to certain adjustments. Immediately following the merger, OncoGenex equityholders are expected to own approximately 25% of the outstanding capital stock of the combined company on a fully diluted basis, and the Achieve stockholders are expected to own approximately 75% of the outstanding capital stock of the combined company on a fully diluted basis. Accordingly, the issuance of shares of OncoGenex’s common stock to Achieve stockholders in the merger will reduce significantly the relative voting power of each share of OncoGenex common stock held by its current equityholders. Consequently, OncoGenex equityholders as a group will have significantly less influence over the management and policies of the combined company after the merger than prior to the merger.

OncoGenex has incurred and will continue to incur significant transaction costs in connection with the merger.

OncoGenex has incurred and will continue to incur significant transaction costs in connection with the merger. It estimates that it will incur aggregate direct transaction costs of approximately $2.8 million associated with the merger and $0.5 million that it may pay on behalf of Achieve, as well as additional costs associated with the commencement of the combined company’s operation as a public company, which cannot be estimated accurately at this time.

The pendency of the merger could have an adverse effect on the trading price of OncoGenex common stock and its business, financial condition, results of operations or business prospects.

While there have been no significant adverse effects to date, the pendency of the merger could disrupt OncoGenex’s businesses in the following ways, including:

Should they occur, any of these matters could adversely affect the trading price of OncoGenex common stock or harm its financial condition, results of operations or business prospects.

As a result of the custirsen phase 3 trial results and the reductions in its workforce, OncoGenex has only 11 employees remaining. If OncoGenex is unable to retain the remaining employees, its ability to consummate the pending merger may be delayed or seriously jeopardized.

In February, October and November 2016, OncoGenex announced workforce reductions, which have reduced the headcount to 11 remaining employees. Its cash conservation activities may yield unintended consequences, such as attrition beyond the planned reductions in workforce and reduced employee morale, which may cause the remaining 11 employees to seek alternate employment. Competition among biotechnology companies for qualified employees is intense, and the ability to retain the remaining employees is critical to its ability to effectively manage OncoGenex’s resources and to consummate the pending merger. Additional attrition could have a material adverse effect on its business, including delaying the completion of wind down activities related to its custirsen clinical trials and related operations and increasing the time and funds required. In addition, as a result of the reduction in its workforce, OncoGenex faces an increased risk of employment litigation.

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Risks Related to OncoGenex’s Business

OncoGenex has incurred losses since inception and anticipates that it will continue to incur losses for the foreseeable future. It has never had any products available for commercial sale and it may never achieve or sustain profitability.

OncoGenex is a clinical-stage biopharmaceutical company, is not profitable, has incurred losses in each year since its inception and does not expect to become profitable in the foreseeable future. OncoGenex has never had any products available for commercial sale, and it has not generated any revenue from product sales nor does it anticipate that it will generate revenue from product sales in the near future. OncoGenex’s revenue to date has been collaboration revenue under the Collaboration Agreement with Teva, which was terminated in April 2015. In addition, custirsen did not demonstrate its intended benefit in any phase 3 clinical trial and its development has been discontinued. Its other product candidate, apatorsen, is earlier in its development and will require a collaboration partner to fund the required additional development. OncoGenex has not yet submitted any products for approval by regulatory authorities, and it continues to incur research and development and general and administrative expenses related to its operations. OncoGenex expects to continue to incur losses for the foreseeable future. If it does not find a collaboration partner to fund additional development of apatorsen or apatorsen otherwise fails in clinical trials or does not gain regulatory approval, or if apatorsen does not achieve market acceptance, OncoGenex may never become profitable. Even if it achieves profitability in the future, OncoGenex may not be able to sustain profitability in subsequent periods.

OncoGenex cannot give any assurance that apatorsen will continue to be developed, receive regulatory approval or be successfully commercialized.

OncoGenex conducted seven randomized phase 2 clinical trials evaluating apatorsen in several cancer indications. All but one of the phase 2 clinical trials for apatorsen failed to meet their pre-defined clinical endpoints. Completing additional clinical trials will be required to establish the safety and efficacy of this product candidate. OncoGenex currently does not have sufficient capital to conduct additional clinical trials for apatorsen without collaborating with a strategic partner, raising additional funds or completing a strategic transaction committed to the development of apatorsen. OncoGenex is currently undertaking efforts to identify a third party to develop and, if approved, commercialize apatorsen. If it identifies such a third party by August 17, 2017 and its pending acquisition is completed, OncoGenex stockholders will receive contingent value rights, or CVRs, to receive 80% of the consideration, less certain offsets, received by the combined company during the five-year period after the completion of the merger as a result of the achievement of certain clinical milestones, regulatory milestones, sales-based milestones and/or up-front payment milestones relating to apatorsen. OncoGenex cannot give any assurance that it will be able to identify and enter into an agreement with a third party to develop and potentially commercialize apatorsen by August 17, 2017, or if it does, that any consideration will ever be received by the combined company or distributed to its stockholders. If OncoGenex is unable to enter into an agreement with a third party regarding the development of apatorsen by August 17, 2017, the development of apatorsen may be delayed or terminated.

If OncoGenex is able to enter into an agreement with a third party to develop apatorsen, the failure of apatorsen to be shown safe or effective in one or more indications could negatively impact the development of apatorsen in other indications, could result in the suspension or termination of apatorsen development and commercialization plans and could cause the CVRs to be of no or little value. Further, apatorsen consideration, if any, received beyond August 2022 would accrue to the benefit of the combined company stockholders generally and not to the CVR holders.

OncoGenex’s clinical development program for apatorsen may not receive regulatory approval either if apatorsen fails to demonstrate that it is safe and effective in clinical trials and consequently fail to obtain necessary approvals from the regulatory agencies, or if it has inadequate financial or other resources to advance apatorsen through the clinical trial process. If competitive products developed by third parties show significant benefit in the cancer indications in which it is developing apatorsen, any planned supportive or primary registration trials

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may be delayed, altered or not initiated and apatorsen may never receive regulatory approval. Any failure to obtain regulatory approval of apatorsen could have a material and adverse effect on OncoGenex’s business.

Because OncoGenex depends on financing from third parties for its operations, its business may fail if such financing becomes unavailable or is not available on commercially reasonable terms.

To date, OncoGenex has financed its operations primarily through the sale of its equity securities and from payments it received pursuant to the Collaboration Agreement with Teva. In April 2015, its Collaboration Agreement with Teva was terminated, and OncoGenex will not receive any future payments from Teva. OncoGenex believes that its existing capital resources and interest on such resources will be sufficient to meet its current operating requirements for at least the next 12 months. However, if the timeline to complete the recently announced merger takes longer than anticipated or is not completed, OncoGenex changes its development plans or elects to further develop apatorsen, cannot find third-party collaborators to fund further development of apatorsen, its trials proceed slower or take longer than expected to complete, it acquires rights to new product candidates, does not successfully defend litigation or engages in commercialization and product launch activities, it will need additional capital sooner than it expects. OncoGenex’s future capital requirements will depend on many factors, including, without limitation:

If OncoGenex is unable to raise funds on acceptable terms when it becomes necessary to do so, it may not be able to continue developing apatorsen, acquire or develop additional product candidates or respond to competitive pressures or unanticipated requirements. For these reasons, any inability to raise additional funds when necessary could have a material adverse effect on OncoGenex’s business.

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OncoGenex intends to partner with third-party collaborators with respect to the development and commercialization of apatorsen, and it cannot control whether it will be able to do so on favorable terms, if at all.

OncoGenex is currently undertaking efforts to identify and enter into an agreement with a third party to fund and undertake the development and potential commercialization of apatorsen. If it is not able to do so by August 2017 and the pending merger is completed, the CVRs will be terminated and the CVR holders will not realize any value from the CVRs.

OncoGenex will be competing with many other companies as it seeks partners for apatorsen and may not be able to compete successfully against those companies. If it is not able to enter into collaboration arrangements for apatorsen, OncoGenex would be required to undertake and fund further development, clinical trials, manufacturing and commercialization activities solely at its own expense and risk. If OncoGenex is unable to finance and/or successfully execute those expensive activities, or it delays such activities due to capital availability, its business could be materially and adversely affected, and potential future product launch could be materially delayed, be less successful, or it may be forced to discontinue clinical development of its product candidate.

Clinical trials may not demonstrate a clinical benefit of apatorsen.

Positive results from preclinical studies and clinical trials, including any exploratory results from the apatorsen clinical trials conducted to date should not be relied on as evidence that on-going, amended, or later-stage or large-scale clinical trials will succeed.

OncoGenex, or a collaboration partner, will be required to demonstrate with substantial evidence through well-controlled clinical trials that apatorsen is safe and effective for use in a diverse population before it or a collaboration partner can seek regulatory approvals for its commercial sale. Success in early clinical trials does not mean that future clinical trials will be successful because evaluation of apatorsen in later-stage clinical trials may fail to demonstrate sufficient safety and efficacy to the satisfaction of regulatory agencies, despite having progressed through initial clinical trials. For example, all of OncoGenex’s phase 3 clinical trials for custirsen failed to meet their clinical endpoints, even after encouraging results in earlier trials. Further, preliminary or top-line results from clinical trials may not be confirmed in final data, or may change materially.

Even after the completion of phase 3 clinical trials, regulatory agencies may disagree with OncoGenex’s clinical trial design and its interpretation of data, and may require OncoGenex to conduct additional clinical trials to demonstrate the efficacy of apatorsen.

OncoGenex may choose to make amendments to ongoing studies for any reason including to analyze final top line data earlier than planned. Any future amendments may compromise the integrity of the clinical trial results and may not be acceptable to regulators.

OncoGenex relies on third parties to manufacture and supply apatorsen and other agents used in its clinical trials and potential future commercial use. A decrease in the availability or quality of apatorsen or agents could increase clinical trial costs, delay or halt clinical development or regulatory approval or commercialization of apatorsen, resulting in additional losses and depriving OncoGenex of potential product revenue.

OncoGenex does not own or operate manufacturing facilities, and it depends on third-party contract manufacturers for production of apatorsen and relies on other companies and their manufacturers for other agents used in all of its clinical trials. OncoGenex lacks the resources and the capability to manufacture apatorsen itself. To date, its product candidates, including apatorsen, have been manufactured in limited quantities for preclinical studies and clinical trials. All active pharmaceutical ingredients, or API, and drug product for its product candidates have been manufactured for OncoGenex by third parties pursuant to a purchase order or short-term contract that has been fulfilled.

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If, in the future, apatorsen is approved for commercial sale, OncoGenex or any pharmaceutical partner that has licensed apatorsen, if any, may need to manufacture apatorsen in commercial quantities. OncoGenex cannot provide assurance that the third-party manufacturers with which it has contracted in the past will have sufficient capacity to satisfy future manufacturing needs, that additional purchases of API or drug product will be negotiated with these or alternative manufacturers on terms favorable to it, if at all, or that the pharmaceutical partner that has licensed apatorsen, if any, will have sufficient capacity or expertise to satisfy future needs.

Third-party manufacturers may fail to perform under their contractual obligations, or may fail to deliver the required commercial quantities of bulk API or finished drug product on a timely basis and at commercially reasonable prices. OncoGenex has experienced manufacturing quality issues resulting in an unusable lot of one of its product candidates in the past. Any performance failure on the part of its contract manufacturers could delay clinical development or regulatory approval or commercialization of apatorsen, depriving OncoGenex of potential product revenue and resulting in additional losses. If an alternate manufacturer is required to be identified and qualified, clinical trials, regulatory submissions, required approvals or commercialization of apatorsen may be delayed or suspended, which may cause higher costs and could prevent successful commercialization of apatorsen. If one or more replacement manufacturers capable of production at a reasonably favorable cost, in adequate volumes, of adequate quality and on a timely basis, cannot be identified, demand for apatorsen likely cannot be met and clinical trials could be delayed or OncoGenex could lose potential revenue. The ability to replace an existing API manufacturer may be difficult because the number of potential manufacturers is limited to approximately five manufacturers, and regulatory agencies must inspect any replacement manufacturer and review information related to product produced at the manufacturer before they can begin manufacturing OncoGenex’s product candidates. It may be difficult or impossible to identify and engage a replacement manufacturer on acceptable terms in a timely manner, if at all. OncoGenex expects to continue to depend on third-party contract manufacturers for the foreseeable future.

Apatorsen requires precise, high-quality manufacturing. Any of OncoGenex’s contract manufacturers will be subject to ongoing periodic unannounced inspection by regulatory agencies to ensure strict compliance with current Good Manufacturing Practices, or cGMP, and other applicable government regulations and corresponding standards. If a contract manufacturer fails to achieve and maintain high manufacturing standards in compliance with cGMP regulations, manufacturing errors may be experienced resulting in patient injury or death, product recalls or withdrawals, delays or interruptions of production or failures in product testing or delivery, delay or prevention of filing or approval of marketing applications for apatorsen, cost overruns or other problems that could seriously affect OncoGenex’s business.

Significant manufacturing scale-up may require additional validation studies, which the regulatory agencies must review and approve. Additionally, any third-party manufacturers retained to manufacture apatorsen on a commercial scale must pass regulatory agencies’ pre-approval inspection for conformance to cGMP regulations before approval of apatorsen can be obtained. If manufacturing capacity for apatorsen in conformance with cGMP regulations is not successfully increased, the regulatory approval or commercial launch of apatorsen may be delayed or there may be a shortage in supply.

OncoGenex also relies on third parties for the provision of other agents used in its clinical trials, and in some circumstances these agents are provided to it at no cost. OncoGenex has no assurance that these third-parties will continue to provide their products to it at no cost.

If its competitors develop and market products that are more effective, safer or less expensive than apatorsen, OncoGenex’s clinical trials and commercial opportunities will be negatively affected.

The life sciences industry is highly competitive, and OncoGenex faces significant competition from many pharmaceutical, biopharmaceutical and biotechnology companies that are researching and marketing products designed to address cancer indications for which apatorsen is currently being developed or for which apatorsen may be developed in the future. It is aware of several other companies that are developing therapeutics that seek

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to promote tumor cell death. Several therapies have been recently approved by the FDA in indications for which apatorsen may be developed in the future, and OncoGenex expects more to be approved in the future.

Substantial advancements in the treatment of cancer have occurred in the past two years and new products from OncoGenex’s competitors have been approved for marketing on the basis of showing a survival advantage. Apatorsen may be developed in the future by a collaboration partner in any number of cancer indications, including in bladder cancer. Any product OncoGenex may develop in the future is likely to face competition from other drugs and therapies. Many of its competitors have significantly greater financial, manufacturing, marketing and drug development resources than OncoGenex does. Large pharmaceutical companies, in particular, have extensive experience in clinical testing and in obtaining regulatory approvals for drugs. These companies also have significantly greater research and marketing capabilities than OncoGenex does. In addition, many universities and private and public research institutes are, or may become, active in cancer research, and develop products that may directly compete with OncoGenex. If its competitors market products that are more effective, safer or less expensive than its future product candidates, if any, or that reach the market sooner than its future product candidates, if any, OncoGenex may not achieve commercial success.

If new therapies become broadly used, additional clinical trials of apatorsen in combination with these new therapies may be required to demonstrate safety and efficacy of the combination. Additional trials will delay the development of apatorsen and increase OncoGenex’s costs. The failure of apatorsen to work in combination with these new therapies would have an adverse effect on its business.

As new therapies are developed, these therapies will need to be assessed to determine whether to conduct clinical trials of apatorsen in combination with them to demonstrate safety and efficacy of the combination. If it is determined appropriate to conduct additional clinical trials of apatorsen in combination with these new therapies, the development of apatorsen will be delayed and OncoGenex’s costs will be increased. If these clinical trials generate safety concerns or lack of efficacy, its business would be adversely affected.

OncoGenex relies, in part, on third parties to conduct its clinical trials for apatorsen and may rely on third parties to conduct future clinical trials, if any. If these third parties do not successfully carry out their contractual duties or meet expected deadlines, regulatory approval for or commercialization of apatorsen may not be obtained.

To implement its product development strategies, OncoGenex relies on third parties, such as collaborators, contract research organizations, medical institutions, clinical investigators and contract laboratories, to conduct clinical trials of apatorsen. Although it relies on third parties to conduct its clinical trials, OncoGenex is responsible for ensuring that each of its clinical trials is conducted in accordance with its development plan and protocol. Moreover, regulatory agencies require OncoGenex to comply with regulations and standards, commonly referred to as Good Clinical Practices, or GCPs, for conducting, monitoring, recording and reporting the results of clinical trials to ensure that the data and results are scientifically credible and accurate and that the clinical trial subjects are adequately informed of the potential risks of participating in clinical trials. Its reliance on third parties does not relieve OncoGenex of these responsibilities and requirements. If the third parties conducting its clinical trials do not perform their contractual duties or obligations, do not meet expected deadlines or need to be replaced or if the quality or accuracy of the clinical data they obtain is compromised due to the failure to adhere to GCPs or for any other reason, OncoGenex may need to enter into new arrangements with alternative third parties and its clinical trials may be extended, delayed or terminated. In addition, a failure by such third parties to perform their obligations in compliance with GCPs may cause its clinical trials to fail to meet regulatory requirements, which may require OncoGenex to repeat its clinical trials.

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OncoGenex’s clinical trial may be suspended or terminated at any time, including by regulatory agencies, by a Data Safety Monitoring Board overseeing the clinical trial at issue, by a clinical trial site or investigator, or by it. Any failure or significant delay in completing its clinical trial for apatorsen could materially harm the commercial prospects for apatorsen.

OncoGenex does not know whether its clinical trial for apatorsen will proceed or be completed on schedule, if at all, or whether it will be able to identify a collaboration partner to fund and manage any future preclinical studies or clinical trials, as applicable. The completion of its clinical trial currently in progress could also be substantially delayed or prevented by several factors, including:

Apatorsen may cause undesirable and potentially serious side effects during clinical trials that could delay or prevent its regulatory approval or commercialization.

Adverse events have been reported for patients in all of the clinical trials evaluating apatorsen, and serious adverse events were reported for approximately half the patients in a Phase 1 clinical trial evaluating apatorsen in patients with solid tumors. Since patients in OncoGenex’s clinical trials have advanced stages of cancer, OncoGenex expects that additional adverse events, including serious adverse events, will occur.

Undesirable side effects caused by apatorsen could cause OncoGenex or regulatory authorities to amend, interrupt, delay or halt clinical trials and could result in the denial of regulatory approval by regulatory agencies for any or all targeted indications or decrease the competitive opportunity of apatorsen which may decrease sales potential. This, in turn, could prevent commercialization of apatorsen and generating revenue from its sale. In addition, if apatorsen receives marketing approval and OncoGenex or others later identify undesirable side effects caused by the product:

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Any one or a combination of these events could prevent achievement or maintenance of market acceptance of apatorsen or could substantially increase the costs and expenses of commercializing the product, which in turn could delay or prevent the generation of significant revenue from the sale of the product. Historical events have raised questions about the safety of other companies’ marketed drugs and may result in increased cautiousness by regulatory agencies in reviewing new drugs based on safety, efficacy or other regulatory considerations and may result in significant delays in obtaining regulatory approvals, additional clinical trials being required, or more stringent product labeling requirements. Any delay in obtaining, or the inability to obtain, applicable regulatory approvals would prevent commercialization of apatorsen.

If OncoGenex were to be successfully sued related to its products or operations, it could face substantial liabilities that may exceed its resources.

OncoGenex may be held liable if any of its products or operations cause injury or death or are found otherwise unsuitable during product testing, manufacturing, marketing or sale. These risks are inherent in the development of pharmaceutical products. OncoGenex currently maintains commercial general and umbrella liability policies with combined limits of $10.0 million per occurrence and in the aggregate, in addition to a $10.0 million per claim and annual aggregate product liability insurance policy related to its clinical trials consistent with industry standards. When necessary for its products, OncoGenex intends to obtain additional product liability insurance. Insurance coverage may be prohibitively expensive, may not fully cover potential liabilities or may not be available in the future. Inability to obtain sufficient insurance coverage at an acceptable cost or otherwise to protect against potential product liability claims could prevent or inhibit the commercialization of its products. If OncoGenex were to be sued for any injury caused by or associated with its products or operations, the litigation could consume substantial time and attention of OncoGenex management, and the resulting liability could exceed its total assets.

Even if regulatory approval to market apatorsen is received, the market may not be receptive to the product.

Even if apatorsen obtains regulatory approval, it may not gain market acceptance among physicians, patients, healthcare payors and/or the medical community. OncoGenex believes that the degree of market acceptance will depend on a number of factors, including:

If OncoGenex’s future product candidates fail to achieve market acceptance, it may not be able to generate significant revenue or achieve or sustain profitability.

The successful commercialization of apatorsen will depend in part on the extent to which governmental authorities and health insurers establish adequate coverage and reimbursement levels and pricing policies.

Successful sales of apatorsen will depend, in part, on the extent to which coverage and reimbursement for the product will be available from government and health administration authorities, private health insurers and other third-party payors. To manage healthcare costs, many governments and third-party payors increasingly scrutinize the pricing of new products and require greater levels of evidence of favorable clinical outcomes and cost-

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effectiveness before extending coverage. In light of such challenges to prices, OncoGenex cannot be sure that coverage for apatorsen will be obtained or, if available, that the reimbursement rates will be adequate. If adequate levels of coverage and reimbursement for apatorsen cannot be attained, its marketability will be negatively and materially impacted.

Moreover, eligibility for coverage and reimbursement does not imply that a drug will be paid for in all cases or at a rate that covers costs, including research, development, manufacture, sale and distribution. In addition, obtaining and maintaining adequate coverage and reimbursement status is time-consuming and costly. Third party payors may deny coverage and reimbursement status altogether of a given drug product, or cover the product but may also establish prices at levels that are too low to enable OncoGenex to realize an appropriate return on its investment in product development. Further, one payor’s determination to provide coverage for a product does not assure that other payors will also provide coverage for the product. Because the rules and regulations regarding coverage and reimbursement change frequently, in some cases at short notice, even when there is favorable coverage and reimbursement, future changes may occur that adversely impact the favorable status.

The unavailability or inadequacy of third-party coverage and reimbursement could have a material adverse effect on the market acceptance of any of its future products and the future revenues OncoGenex may expect to receive from those products. In addition, it is unable to predict what additional legislation or regulation relating to the healthcare industry or third-party coverage and reimbursement may be enacted in the future, or what effect such legislation or regulation would have on its business.

OncoGenex may fail to acquire and develop additional products or product candidates at all or on commercially reasonable terms.

OncoGenex currently does not have internal discovery capabilities and depends on pharmaceutical and biotechnology companies and other researchers to sell or license products or product candidates to it. If it is unable to complete the merger with Achieve, OncoGenex may be required to identify alternative sources of product candidates.

To successfully build a product pipeline, OncoGenex would be required to identify, select and acquire pharmaceutical product candidates. Proposing, negotiating and implementing an economically viable product acquisition or license is a lengthy and complex process. OncoGenex competes for partnering arrangements and license agreements with pharmaceutical and biotechnology companies and academic research institutions. Its competitors may have stronger relationships with third parties with whom OncoGenex is interested in collaborating and/or may have more established histories of developing and commercializing products. As a result, its competitors may have a competitive advantage in entering into partnering arrangements with such third parties. In addition, even if OncoGenex finds promising product candidates, and generate interest in a partnering or strategic arrangement to acquire such product candidates, it may not be able to acquire rights to additional product candidates or approved products on terms that it finds acceptable, if at all. If OncoGenex fails to acquire and develop product candidates from others, it may be unable to grow its business.

OncoGenex expects that any product candidate that it acquires rights to will require additional development efforts prior to commercial sale, including extensive clinical evaluation and approval by regulatory agencies. All product candidates are subject to the risks of failure inherent in pharmaceutical product development, including the possibility that the product candidate will not be shown to be sufficiently safe and effective for approval by regulatory authorities. Even if the product candidates are approved, OncoGenex can make no assurance that it would be capable of economically producing the product or that the product would be commercially successful.

OncoGenex may be adversely affected if its controls over financial reporting fail or are circumvented.

OncoGenex regularly reviews and updates its internal controls, disclosure controls and procedures, and corporate governance policies. In addition, although not required, OncoGenex has chosen under the Sarbanes Oxley Act of

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2002 to report annually on its internal control over financial reporting. If it were to be determined that its internal control over financial reporting is not effective, such shortcoming could have an adverse effect on its business and financial results and the price of OncoGenex common stock could be negatively affected. This reporting requirement could also make it more difficult or more costly for it to obtain certain types of insurance, including director and officer liability insurance, and OncoGenex may be forced to accept reduced policy limits and coverage or incur substantially higher costs to obtain the same or similar coverage. Any system of internal controls, however well designed and operated, is based in part on certain assumptions and can provide only reasonable, not absolute, assurances that the objectives of the system are met. Any failure or circumvention of the controls and procedures or failure to comply with regulation concerning control and procedures could have a material effect on OncoGenex’s business, results of operation and financial condition. Any of these events could result in an adverse reaction in the financial marketplace due to a loss of investor confidence in the reliability of its financial statements, which ultimately could negatively affect the market price of its shares, increase the volatility of OncoGenex stock price and adversely affect its ability to raise additional funding. The effect of these events could also make it more difficult for OncoGenex to attract and retain qualified persons to serve on its Board and its Board committees and as executive officers.

Risks Related to OncoGenex’s Intellectual Property

OncoGenex’s proprietary rights may not adequately protect apatorsen.

OncoGenex’s commercial success will depend in part on its ability to obtain patents and/or regulatory exclusivity and maintain adequate protection for apatorsen in the United States and other countries. OncoGenex or a collaboration partner, if any, will be able to protect its proprietary rights from unauthorized use by third parties only to the extent that apatorsen is covered by valid and enforceable patents or are effectively maintained as trade secrets.

OncoGenex and/or a collaboration partner, if any, may apply for additional patents covering apatorsen as it deems appropriate. OncoGenex or its collaboration partner, if any, may, however, fail to apply for patents on important technologies or apatorsen in a timely fashion, if at all. Its existing patents and any future patents OncoGenex or its collaboration partner, if any, obtain may not be sufficiently broad to prevent others from practicing its technologies or from developing competing products and technologies. In addition, OncoGenex does not always control the patent prosecution of subject matter that it licenses from others. Accordingly, OncoGenex is sometimes unable to exercise a significant degree of control over such intellectual property as it would over its own.

Moreover, the patent positions of biopharmaceutical companies are highly uncertain and involve complex legal and factual questions for which important legal principles remain unresolved. As a result, the validity and enforceability of OncoGenex’s patents cannot be predicted with certainty. In addition, the U.S. Supreme Court has revised certain tests regarding granting patents and assessing the validity of patents to make it more difficult to obtain patents. As a consequence, issued patents may be found to contain invalid claims according to the revised standards. Some of its patents or those of collaborators may be subject to challenge and subsequent invalidation or significant narrowing of claim scope in a re-examination proceeding, or during litigation, under the revised criteria. OncoGenex cannot guarantee that:

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The actual protection afforded by a patent varies on a product-by-product basis, from country to country and depends on many factors, including the type of patent, the scope of its coverage, the availability of regulatory related extensions, the availability of legal remedies in a particular country and the validity and enforceability of the patents. OncoGenex’s ability or the ability of a collaboration partner, if any, to maintain and solidify its proprietary position for apatorsen will depend on its success in obtaining effective claims and enforcing those claims once granted. OncoGenex’s issued patents and those that may issue in the future, or those licensed to it or collaboration partners, if any, may be challenged, invalidated, unenforceable or circumvented, and the rights granted under any issued patents may not provide it with proprietary protection or competitive advantages against competitors with similar products. Due to the extensive amount of time required for the development, testing and regulatory review of a potential product, it is possible that, before apatorsen can be commercialized, any related patent may expire or remain in force for only a short period following commercialization, thereby reducing any advantage of the patent.

OncoGenex also relies on trade secrets to protect some of its technology, especially where it is believed that patent protection is not appropriate or obtainable. However, trade secrets are difficult to maintain. While it uses reasonable efforts to protect its trade secrets, OncoGenex or its collaboration partners’ employees, consultants, contractors or scientific and other advisors may unintentionally or willfully disclose its proprietary information to competitors. Enforcement of claims that a third party has illegally obtained and is using trade secrets is expensive, time consuming and uncertain. In addition, non-U.S. courts are sometimes less willing than U.S. courts to protect trade secrets. If its competitors independently develop equivalent knowledge, methods and know-how, OncoGenex would not be able to assert its trade secrets against them and its business could be harmed.

OncoGenex may not be able to protect its intellectual property rights throughout the world.

Filing, prosecuting and defending patents on apatorsen, when and if OncoGenex has any, in every jurisdiction would be prohibitively expensive. Competitors may use its technologies in jurisdictions where OncoGenex or its licensors have not obtained patent protection to develop their own products. These products may compete with its products, when and if OncoGenex has any, and may not be covered by any of OncoGenex or its licensors’ patent claims or other intellectual property rights.

The laws of some non-U.S. countries do not protect intellectual property rights to the same extent as the laws of the United States, and many companies have encountered significant problems in protecting and defending such rights in foreign jurisdictions. The legal systems of certain countries, particularly certain developing countries, do not favor the enforcement of patents and other intellectual property protection, particularly those relating to biotechnology and/or pharmaceuticals, which could make it difficult for OncoGenex to stop the infringement of its patents. Proceedings to enforce its patent rights in foreign jurisdictions could result in substantial cost and divert OncoGenex’s efforts and attention from other aspects of its business.

OncoGenex may become involved in disputes with past or potential future collaborators over intellectual property ownership, and publications by its research collaborators and scientific advisors could impair its ability to obtain patent protection or protect its proprietary information, which, in either case, could have a significant effect on its business.

Inventions discovered under research, material transfer or other such collaborative agreements may become jointly owned by OncoGenex and the other party to such agreements in some cases and the exclusive property of

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either party in other cases. Under some circumstances, it may be difficult to determine who owns a particular invention, or whether it is jointly owned, and disputes could arise regarding ownership of those inventions. These disputes could be costly and time consuming and an unfavorable outcome could have a significant adverse effect on its business if OncoGenex was not able to protect or license rights to these inventions. In addition, OncoGenex’s research collaborators and scientific advisors generally have contractual rights to publish its data and other proprietary information, subject to its prior review. Publications by its research collaborators and scientific advisors containing such information, either with its permission or in contravention of the terms of their agreements with OncoGenex, may impair its ability to obtain patent protection or protect its proprietary information, which could significantly harm its business.

The intellectual property protection for apatorsen depends on third parties.

OncoGenex has exclusively licensed from UBC certain issued patents and pending patent applications covering the respective antisense sequences underlying apatorsen and its commercialization and use, and it has licensed from Ionis certain issued patents and pending patent applications directed to product compositions and chemical modifications used in apatorsen for commercialization, use and the manufacturing thereof. OncoGenex has also received a sublicense from Ionis under certain third-party patent portfolios directed to such modifications.

The patents and pending patent applications underlying OncoGenex’s licenses do not fully cover all potential modifications and uses of apatorsen. In the case of patents and patent applications licensed from Ionis, OncoGenex does not have and has not had any control over the filing, prosecution or enforcement of these patents or patent applications. It cannot be certain that such prosecution efforts have been or will be conducted in compliance with applicable laws and regulations or will result in valid and enforceable patents. OncoGenex also cannot be assured that its licensors or their respective licensing partners will agree to enforce any such patent rights at its request or devote sufficient efforts to attain a desirable result. Any failure by its licensors or any of their respective licensing partners to properly protect the intellectual property rights relating to apatorsen could have a material adverse effect on OncoGenex’s financial condition and results of operation.

If OncoGenex breaches any of the agreements under which it licenses rights to apatorsen or technology from third parties, it could lose license rights that are important to its business. Certain of OncoGenex’s license agreements may not provide an adequate remedy for a breach by the licensor.

OncoGenex licenses the development and commercialization rights for apatorsen. Under such licenses, it is subject to various obligations such as sublicensing, royalty and milestone payments, annual maintenance fees, limits on sublicensing, insurance obligations and the obligation to use commercially reasonable best efforts to develop and exploit the licensed technology. If OncoGenex fails to comply with any of these obligations or otherwise breach these agreements, its licensors may have the right to terminate the license in whole or in part or to terminate the exclusive nature of the license. OncoGenex may also become involved in disputes with current or former licensors regarding the meaning of certain terms in the license agreements, including terms related to royalty and milestone payments and termination, which may result in costly and time consuming litigation. Loss of any of these licenses or the exclusivity rights provided by the licenses, or disputes with current or former licensors, could harm OncoGenex’s financial condition and results of operations. In addition, certain of its license agreements with UBC eliminate OncoGenex’s ability to obtain money damages in respect of certain claims against UBC.

The patent protection for apatorsen may expire before OncoGenex is able to maximize its commercial value, which may subject it to increased competition and reduce or eliminate its opportunity to generate product revenue.

The patents for apatorsen have varying expiration dates and, when these patents expire, OncoGenex may be subject to increased competition and it may not be able to recover its development costs. For example, certain of the U.S. patents directed to apatorsen and its use that have been licensed from UBC are expected to expire in

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2023. In some of the larger economic territories, such as the United States and Europe, patent term extension/restoration may be available to compensate for time taken during aspects of the product candidate’s regulatory review. OncoGenex cannot, however, be certain that an extension will be granted or, if granted, what the applicable time period or the scope of patent protection afforded during any extended period will be. In addition, even though some regulatory agencies may provide some other exclusivity for a product candidate under its own laws and regulations, OncoGenex may not be able to qualify the product candidate or obtain the exclusive time period.

If it is unable to obtain patent term extension/restoration or some other exclusivity, OncoGenex could be subject to increased competition and its opportunity to establish or maintain product revenue could be substantially reduced or eliminated. Furthermore, it may not have sufficient time to recover its development costs prior to the expiration of its U.S. and non-U.S. patents.

OncoGenex may incur substantial costs as a result of litigation or other proceedings relating to patent and other intellectual property rights and it may be unable to protect its rights to, or use of, its technology.

If OncoGenex chooses to go to court to stop someone else from using the inventions claimed in its patents or its licensed patents, that individual or company has the right to ask the court to rule that these patents are invalid and/or should not be enforced against that third party. These lawsuits are expensive and would consume time and other resources even if OncoGenex was successful in stopping the infringement of these patents. In addition, there is a risk that the court will decide that these patents are invalid or unenforceable and that OncoGenex does not have the right to stop the other party from using the inventions. The U.S. Supreme Court has revised certain tests regarding granting patents and assessing the validity of patents to make it more difficult to obtain patents. Some of its issued patents may be subject to challenge and subsequent invalidation under the revised criteria. There is also the risk that, even if the validity or enforceability of these patents is upheld, the court will narrow the scope of OncoGenex’s claim or will refuse to stop the other party on the grounds that such other party’s activities do not infringe its rights.

If OncoGenex wishes to use the technology or compound claimed in issued and unexpired patents owned by others, it will need to obtain a license from the owner, enter into litigation to challenge the validity or enforceability of the patents or incur the risk of litigation in the event that the owner asserts that OncoGenex infringed its patents. The failure to obtain a license to technology or the failure to challenge an issued patent that OncoGenex may require to discover, develop or commercialize apatorsen may have a material adverse effect on it.

If a third party asserts that OncoGenex infringed its patents or other proprietary rights, OncoGenex could face a number of risks that could seriously harm its results of operations, financial condition and competitive position, including:

The biotechnology industry has produced a proliferation of patents, and it is not always clear to industry participants, including OncoGenex, which patents cover various types of products or methods of use. The

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coverage of patents is subject to interpretation by the courts, and the interpretation is not always uniform. If it is sued for patent infringement, OncoGenex would need to demonstrate that apatorsen or methods of use either do not infringe the patent claims of the relevant patent, and/or that the patent claims are invalid, and/or that the patent is unenforceable and it may not be able to do this. Proving invalidity, in particular, is difficult since it requires a showing of clear and convincing evidence to overcome the presumption of validity enjoyed by issued patents.

U.S. patent laws as well as the laws of some foreign jurisdictions provide for provisional rights in published patent applications beginning on the date of publication, including the right to obtain reasonable royalties, if a patent subsequently issues and certain other conditions are met.

Because some patent applications in the United States may be maintained in secrecy until the patents are issued, because patent applications in the United States and many foreign jurisdictions are typically not published until 18 months after filing and because publications in the scientific literature often lag behind actual discoveries, OncoGenex cannot be certain that others have not filed patent applications for technology covered by its licensors’ issued patents or its pending applications or its licensors’ pending applications, or that OncoGenex or its licensors were the first to invent the technology.

Patent applications filed by third parties that cover technology similar to OncoGenex’s technology may have priority over its or its licensors’ patent applications and could further require OncoGenex to obtain rights to issued patents covering such technologies. If another party files a U.S. patent application on an invention similar to OncoGenex’s, OncoGenex may elect to participate in or be drawn into an interference proceeding declared by the U.S. Patent and Trademark Office to determine priority of invention in the United States. The costs of these proceedings could be substantial, and it is possible that such efforts would be unsuccessful, resulting in a loss of its U.S. patent position with respect to such inventions. Some of its competitors may be able to sustain the costs of complex patent litigation more effectively than OncoGenex can because they have substantially greater resources. In addition, any uncertainties resulting from the initiation and continuation of any litigation could have a material adverse effect on its ability to raise the funds necessary to continue its operations. OncoGenex cannot predict whether third parties will assert these claims against it or against the licensors of technology licensed to OncoGenex, or whether those claims will harm its business. If OncoGenex is forced to defend against these claims, whether they are with or without any merit and whether they are resolved in favor of or against it or its licensors, OncoGenex may face costly litigation and diversion of management’s attention and resources. As a result of these disputes, it may have to develop costly non-infringing technology, or enter into licensing agreements. These agreements, if necessary, may be unavailable on terms acceptable to OncoGenex, if at all, which could seriously harm its business or financial condition.

OncoGenex may be subject to damages resulting from claims that it, or its employees or consultants, have wrongfully used or disclosed alleged trade secrets of third parties.

Many of OncoGenex’s employees were previously employed, and certain of its consultants are currently employed, at universities or biotechnology or pharmaceutical companies, including its competitors or potential competitors. Although it has not received any claim to date, OncoGenex may be subject to claims that these employees or consultants or it has inadvertently or otherwise used or disclosed trade secrets or other proprietary information of these current or former employers. Litigation may be necessary to defend against these claims. If it fails in defending such claims, in addition to paying monetary damages, OncoGenex may lose valuable intellectual property rights or personnel. It may be subject to claims that employees of its partners or licensors of technology licensed by OncoGenex have inadvertently or otherwise used or disclosed trade secrets or other proprietary information of their former employers. It may become involved in litigation to defend against these claims. If it fails in defending such claims, in addition to paying monetary damages, OncoGenex may lose valuable intellectual property rights or personnel.

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Risks Related to OncoGenex Common Stock

The price for OncoGenex common stock is volatile.

The market prices for OncoGenex common stock and that of emerging life science companies generally have historically been highly volatile. For example, after the announcement of data from recent custirsen and apatorsen clinical trials, OncoGenex experienced significant decreases in its stock price. Future announcements concerning OncoGenex, its pending merger, the results of its clinical trials or its competitors may also have a significant effect on the market price of its common stock. The stock markets also experience significant price and volume fluctuation unrelated to the operating performance of particular companies. These market fluctuations may also adversely affect the market price of OncoGenex common stock.

An increase in the market price of OncoGenex common stock, which is uncertain and unpredictable, may be the sole source of gain from an investment in its common stock. An investment in its common stock may not be appropriate for investors who require dividend income. OncoGenex has never declared or paid cash dividends on its capital stock and does not anticipate paying any cash dividends on its capital stock in the foreseeable future. OncoGenex currently intends to retain all available funds and any future earnings to fund the development and growth of its business. As a result, capital appreciation, if any, of OncoGenex common stock will be the sole source of gain for stockholders for the foreseeable future. Accordingly, an investment in its common stock may not be appropriate for investors who require dividend income or investors who are not prepared to bear a significant risk of losses from such an investment.

The price of OncoGenex common stock does not meet the requirements for continued listing on The NASDAQ Capital Market. If it fails to regain compliance with the minimum listing requirements, OncoGenex common stock will be subject to delisting. OncoGenex’s ability to complete the pending merger or publicly or privately sell equity securities and the liquidity of its common stock could be adversely affected if its common stock is delisted.

The continued listing standards of The NASDAQ Capital Market require, among other things, that the minimum bid price of a listed company’s stock be at or above $1.00. If the minimum bid price is below $1.00 for a period of more than 30 consecutive trading days, the listed company will fail to be in compliance with The NASDAQ Capital Market’s listing rules and, if it does not regain compliance within the grace period, will be subject to delisting. As previously reported, on August 22, 2016, OncoGenex received a notice from the NASDAQ Listing Qualifications Department notifying it that for 30 consecutive trading days, the bid price of OncoGenex common stock had closed below the minimum $1.00 per share requirement. In accordance with The NASDAQ Capital Market’s listing rules, OncoGenex was afforded 180 calendar days, or until February 21, 2017, to regain compliance with the bid price requirement. In order to regain compliance, the bid price of its common stock must close at a price of at least $1.00 per share for a minimum of 10 consecutive trading days. On February 22, 2017, OncoGenex received a second notice from the NASDAQ Listing Qualifications Department notifying it that it had not regained compliance with the bid price requirement during the 180 calendar days, and that it may be eligible for an additional 180-day compliance period if OncoGenex meets the market value of publicly held shares requirement for continued listing, all other initial inclusion requirements for The NASDAQ Capital Market, except for the bid price requirement, and provide written notice that it intends to regain compliance with the bid price requirement during the second 180-day compliance period, by effecting a reverse stock split if necessary. OncoGenex believes it is eligible for the additional 180-day compliance period, and intends to meet the bid price requirement by effecting a reverse stock split upon the completion of its pending merger.

If OncoGenex fails to regain compliance, its common stock will be subject to delisting. Delisting from The NASDAQ Capital Market could adversely affect its ability to raise additional financing through the public or private sale of equity securities, would significantly affect the ability of investors to trade its securities and would negatively affect the value and liquidity of OncoGenex common stock. Delisting could also have other negative results, including the potential loss of confidence by employees, the loss of institutional investor interest and fewer business development opportunities. Delisting would also prevent OncoGenex from satisfying a closing

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condition for the pending merger, and, in such event, Achieve may elect not to consummate the merger. In addition, the combined company must submit a new application for listing on The NASDAQ Capital Market after the merger pursuant to the reverse merger rules, and the combined company will need to meet NASDAQ’s minimum listing requirements.

OncoGenex is at risk of securities class action litigation.

In the past, securities class action litigation has often been brought against a company following a decline in the market price of its securities, including in circumstances where such declines occur in close proximity to the announcement of clinical trial results, as well as following certain significant business transactions, such as the announcement of a merger. This risk is especially relevant for OncoGenex because it recently announced a pending merger with Achieve. Additionally, its stock price and those of other biotechnology and biopharmaceutical companies have experienced significant stock price volatility in recent years. If OncoGenex faces such litigation, it could result in substantial costs and a diversion of management’s attention and resources, which could harm its business. Any stockholder litigation challenging the pending merger may also delay completion of the merger in the expected timeframe or altogether.

If OncoGenex raises additional capital, the terms of the financing transactions may cause dilution to existing stockholders or contain terms that are not favorable to it.

To date, OncoGenex’s sources of cash have been limited primarily to proceeds from the private or public placement of its securities and reimbursement for custirsen-related development expenses from its prior strategic collaboration with Teva, which terminated in April 2015. In the future, OncoGenex may seek to raise additional financing through private placements or public offerings of its equity or debt securities. It cannot be certain that additional funding will be available on acceptable terms, if at all. To the extent that OncoGenex raises additional financing by issuing equity securities, it may do so at a price per share that represents a discount to the then-current per share trading price of its common stock and its stockholders may experience significant dilution. Any debt financing, if available, may involve restrictive covenants, such as limitations on OncoGenex’s ability to incur additional indebtedness, limitations on its ability to acquire or license intellectual property rights and other operating restrictions that could adversely affect its ability to conduct its business.

Risks Related to OncoGenex’s Industry

There is a high risk that OncoGenex’s drug development activities will not result in commercial products.

OncoGenex or a collaborator, if any, will need to complete significant additional clinical trials before it or they can demonstrate that apatorsen is safe and effective to the satisfaction of regulatory agencies. Clinical trials are expensive and uncertain processes that take years to complete. Failure can occur at any stage of the process, and successful early clinical trials do not ensure that later clinical trials will be successful. In later-stage clinical trials, apatorsen may fail to show desired efficacy and safety traits despite having progressed through initial clinical trials. For example, all of OncoGenex’s phase 3 clinical trials for custirsen and all but one of its phase 2 trials for apatorsen failed to meet their clinical endpoints, even after positive results in earlier trials. A number of companies in the pharmaceutical industry have suffered significant setbacks in advanced clinical trials, even after obtaining promising results in earlier clinical trials. In addition, a clinical trial may prove successful with respect to a secondary objective, but fail to demonstrate clinically significant benefits with respect to a primary objective. Failure to satisfy a primary objective in a phase 3 clinical trial (registration trial) would generally mean that a product candidate would not receive regulatory approval.

The regulatory approval process is expensive, time consuming and uncertain and may prevent OncoGenex from obtaining approvals for the commercialization of some or all of its product candidates.

The research, testing, manufacturing, labeling, approval, selling, marketing and distribution of drug products are subject to extensive regulation by regulatory agencies, which regulations differ from country to country.

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OncoGenex is not permitted to market its product candidate in the United States until it receives approval of an application for market approval from regulatory agencies. OncoGenex has not submitted an application for or received marketing approval for its apatorsen. Obtaining approval of an application for market approval can be a lengthy, expensive and uncertain process. In addition, failure to comply with regulatory agencies’ requirements may, either before or after product approval, if any, subject OncoGenex to administrative or judicially imposed sanctions, including:

Regulatory approval of an application for market approval or application for market approval supplement is not guaranteed, and the approval process is expensive and may take several years. Regulatory agencies also have substantial discretion in the drug approval process. Despite the time and expense exerted, failure can occur at any stage, and OncoGenex or a collaborator, if any, could encounter problems that could cause it or them to abandon clinical trials or to repeat or perform additional preclinical studies and clinical trials. The number of preclinical studies and clinical trials that will be required for regulatory agencies’ approval varies depending on the drug candidate, the disease or condition that the drug candidate is designed to address, and the regulations applicable to any particular drug candidate. Regulatory agencies can delay, limit or deny approval of a drug candidate for many reasons, including:

Even if OncoGenex or a collaborator, if any, obtains regulatory approvals for apatorsen, the terms of approvals and ongoing regulation of apatorsen may limit how it or a collaborator, if any, manufactures and markets apatorsen, which could materially affect its ability to generate revenue.

If apatorsen is approved, it and its manufacturer will be subject to continual review. Any regulatory approval that OncoGenex or a collaborator, if any, receives for apatorsen is likely to be subject to limitations on the indicated uses for which the end product may be marketed, or include requirements for potentially costly post-approval follow-up clinical trials. In addition, if regulatory agencies approve apatorsen, the labeling, packaging, adverse event reporting, storage, advertising and promotion for the end product will be subject to extensive regulatory requirements. The manufacturers of apatorsen, when and if it has any, will also be required to comply with cGMP regulations, which include requirements relating to quality control and quality assurance, as well as the

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corresponding maintenance of records and documentation. Further, regulatory agencies must approve these manufacturing facilities before they can be used to manufacture OncoGenex’s product, when and if apatorsen has any, and these facilities are subject to ongoing regulatory inspection. If the manufacturer fails to comply with the regulatory requirements of regulatory agencies, or if previously unknown problems with apatorsen are discovered, OncoGenex could be subject to administrative or judicially imposed sanctions, including:

In addition, regulatory agencies may change their policies and additional regulations may be enacted that could prevent or delay regulatory approval of apatorsen. OncoGenex cannot predict the likelihood, nature or extent of government regulation that may arise from future legislation or administrative action, either in the United States, Canada or abroad. If it is not able to maintain regulatory compliance, OncoGenex would likely not be permitted to market apatorsen and it may not achieve or sustain profitability.

If government and third-party payors fail to provide coverage and adequate reimbursement rates for apatorsen, OncoGenex’s revenue and potential for profitability will be reduced.

In the United States and elsewhere, OncoGenex’s product revenue will depend principally on the reimbursement rates established by third-party payors, including government health administration authorities, managed-care providers, public health insurers, private health insurers and other organizations. These third-party payors are increasingly challenging the price, and examining the cost-effectiveness, of medical products and services. In addition, significant uncertainty exists as to the reimbursement status, if any, of newly approved drugs, pharmaceutical products or product indications. OncoGenex or a collaborator, if any, may need to conduct post-marketing clinical trials in order to demonstrate the cost-effectiveness of apatorsen, if any. Such clinical trials may require it or a collaborator, if any, to commit a significant amount of management time and financial and other resources. If reimbursement of such product is unavailable or limited in scope or amount or if pricing is set at unsatisfactory levels, its revenue could be reduced.

In some countries other than the United States, particularly the countries of the European Union and Canada, the pricing of prescription pharmaceuticals is subject to governmental control. In these countries, obtaining pricing approval from governmental authorities can take six to 12 months or longer after the receipt of regulatory marketing approval of a product for an indication. To obtain reimbursement or pricing approval in some countries, OncoGenex or a collaborator, if any, may be required to conduct a clinical trial that compares the cost-effectiveness of apatorsen to other available therapies. If reimbursement of such product candidate is unavailable or limited in scope or amount or if pricing is set at unsatisfactory levels, its revenue could be reduced.

Domestic and foreign governments continue to propose and pass legislation designed to reduce the cost of healthcare, including drugs. In the United States, there have been, and OncoGenex expects that there will

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continue to be, federal and state proposals to implement similar governmental control. In addition, increasing emphasis on managed care in the United States will continue to put pressure on the pricing of pharmaceutical products. For example, in March 2010, the Patient Protection and Affordable Care Act, as amended by the Health Care and Education Affordability Reconciliation Act, or collectively, PPACA, became law in the United States. PPACA substantially changes the way healthcare is financed by both governmental and private insurers and significantly affects the pharmaceutical industry.

OncoGenex anticipates that the PPACA, as well as other healthcare reform measures that may be adopted in the future, may result in more rigorous coverage criteria and downward pressure on the price for any approved product, and could seriously harm its prospects. In addition, the Medicare and Medicaid program and state healthcare laws and regulations may also be modified to change the scope of covered products and/or reimbursement methodology. Cost control initiatives could decrease the established reimbursement rates that OncoGenex receives for apatorsen in the future, which would limit its revenue and profitability. Legislation and regulations affecting the pricing of pharmaceutical products, including apatorsen, may change at any time, which could further limit or eliminate reimbursement rates for apatorsen or other product candidates.

Failure to obtain regulatory approval outside of the United States and Canada would prevent OncoGenex from marketing its product candidates abroad.

OncoGenex or a collaborator may market apatorsen outside of the United States and Canada. In order to market apatorsen in the European Union and many other non-North American markets, it or a collaborator, if any, must obtain separate regulatory approvals. OncoGenex has had limited interactions with non-North American regulatory authorities. Approval procedures vary among countries and can involve additional testing, and the time required to obtain approval may differ from that required to obtain FDA approval. Approval by the FDA or other regulatory authorities does not ensure approval by regulatory authorities in other countries, and approval by one or more non-North American regulatory authorities does not ensure approval by regulatory authorities in other countries or by the FDA. The non-North American regulatory approval process may include all of the risks associated with obtaining FDA approval. OncoGenex or a collaborator, if any, may not obtain non-North American regulatory approvals on a timely basis, if at all. It or a collaborator, if any, may not be able to file for non-North American regulatory approvals and may not receive necessary approvals to commercialize apatorsen in any market.

Risks Related to Achieve

Risks Related to Achieve’s Financial Condition and Capital Requirements

Achieve has incurred losses since its inception, has a limited operating history on which to assess its business, and anticipates that it will continue to incur significant losses for the foreseeable future.

Achieve is a clinical development-stage specialty pharmaceutical company with a limited operating history. Achieve has incurred net losses in each year since its inception. The audit report on the consolidated financial statements as of December 31, 2016 and 2015 and for the year ended December 31, 2016 and period ended December 31, 2015, which appears elsewhere herein, includes an explanatory paragraph related to Achieve’s ability to continue as a going concern. As of December 31, 2016, Achieve had a cash balance of $15,000, an accumulated deficit of $1.8 million and a negative working capital balance of $3.1 million. One of the closing conditions of the merger with OncoGenex requires Achieve’s liabilities, other than expenses incurred in connection with the merger, not to exceed $1.2 million. Achieve’s management believes that Achieve may be able to convert some of the liabilities into equity prior to the consummation of the merger.

The ability of Achieve to continue as a going concern is uncertain and dependent on Achieve’s ability to consummate the merger and/or obtain additional financing. To date, Achieve has financed its operations through stockholder loans and debt financing. Achieve’s management believes that if the merger does not occur, existing Achieve shareholders have sufficient capital available to contribute to operate Achieve through December 31,

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2017, and intends to raise additional financing from alternative sources. However, Achieve will continue to require substantial additional capital to continue its clinical development and potential commercialization activities. Accordingly, Achieve will need to raise substantial additional capital to continue to fund its operations. The amount and timing of its future funding requirements will depend on many factors, including the pace and results of its clinical development efforts. Failure to raise capital as and when needed, on favorable terms or at all, would have a negative impact on its financial condition and its ability to develop cytisine.

Pharmaceutical product development is a highly speculative undertaking and involves a substantial degree of risk. Achieve has devoted substantially all of its financial resources to identify, acquire, and develop cytisine, including providing general and administrative support for its operations. To date, Achieve has financed its operations primarily through the sale of equity securities and convertible promissory notes. The amount of its future net losses will depend, in part, on the rate of its future expenditures and its ability to obtain funding through equity or debt financings, strategic collaborations, or grants.

Achieve expects to continue to incur significant expenses and increasing operating losses for the foreseeable future. Achieve further expects that its expenses will increase substantially if and as Achieve:

Further, the net losses Achieve incurs may fluctuate significantly from quarter to quarter and year to year, such that a period-to-period comparison of its results of operations may not be a good indication of its future performance.

Achieve has never generated any revenue from product sales and may never be profitable.

Achieve has no products approved for commercialization and has never generated any revenue from product sales. Achieve’s ability to generate revenue and achieve profitability depends on its ability, alone or with strategic collaborators, to successfully complete the development of, and obtain the regulatory and marketing approvals necessary to commercialize cytisine. Achieve does not anticipate generating revenue from product sales for the foreseeable future. Achieve’s ability to generate future revenue from product sales depends heavily on its success in many areas, including but not limited to:

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Even if a product candidate that Achieve develops is approved for commercial sale, Achieve anticipates incurring significant costs associated with commercializing that candidate. Additionally, if Achieve is not able to generate sufficient revenue from the sale of any approved products to cover its operating costs, Achieve may never become profitable. If Achieve obtains regulatory approval to market a product candidate, its future revenue will depend upon the size of any markets in which its product candidates may receive approval, and its ability to achieve sufficient market acceptance, pricing, reimbursement from third-party payors, and adequate market share for its product candidates in those markets.

Cytisine is currently Achieve’s sole product candidate and there is no guarantee that Achieve will be able to successfully develop and commercialize cytisine.

Achieve is currently dependent on the potential development of a single product candidate, cytisine. Achieve is still developing its sole product candidate, and cytisine cannot be marketed or sold in the United States or in foreign markets until regulatory approval has been obtained from the U.S. Food and Drug Administration, or the FDA, or applicable foreign regulatory agencies. Achieve has not yet submitted an Investigational New Drug, or IND, application or a New Drug Application, or NDA, for cytisine, and the process of obtaining regulatory approval is expensive and time consuming. The FDA and foreign regulatory authorities may never approve cytisine for sale and marketing, and even if cytisine is ultimately approved, regulatory approval may be delayed or limited in the United States or in other jurisdictions. Even if Achieve is authorized to sell and market cytisine in one or more markets, there is no assurance that Achieve will be able to successfully market cytisine or that cytisine will achieve market acceptance sufficient to generate profits. Failure to develop cytisine, to obtain regulatory approval for cytisine, to successfully market cytisine, or to generate profits from the sale of cytisine would have material adverse effects on Achieve’s business, financial condition, and results of operations.

Achieve is dependent upon a single company for the manufacture and supply of cytisine.

Achieve’s single product candidate, cytisine, has been in-licensed from a third party. Achieve is required to continue to contract with Sopharma AD, or Sopharma, to continue Achieve’s development and commercialization, if any, of cytisine pursuant to a supply agreement with Sopharma. If the supply agreement with Sopharma is terminated, Achieve will need to develop or acquire alternative supply and manufacturing capabilities for cytisine, which it may not be able to do on commercially viable terms or at all.

If Achieve is unable to successfully commercialize cytisine due to failure to obtain regulatory approval or due to other risk factors outlined herein, Achieve’s business, financial condition, and results of operations will be materially harmed as cytisine is currently Achieve’s sole product candidate.

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Raising additional capital may cause dilution to Achieve’s stockholders, restrict its operations or require Achieve to relinquish rights.

To the extent that Achieve raises additional capital through the sale of equity, convertible debt or other securities convertible into equity, the ownership interest of Achieve’s stockholders will be diluted, and the terms of these new securities may include liquidation or other preferences that adversely affect rights of Achieve’s stockholders. Debt financing, if available at all, would likely involve agreements that include covenants limiting or restricting Achieve’s ability to take specific actions, such as incurring additional debt, making capital expenditures, making additional product acquisitions, or declaring dividends. If Achieve is unable to obtain funding on a timely basis, or on terms acceptable to Achieve, or at all, Achieve may be required to delay or discontinue one or more of its development programs or the commercialization of its product candidate or be unable to expand its operations or otherwise capitalize on potential business opportunities, which could materially harm Achieve’s business, financial condition, and results of operations.

Achieve’s principal stockholders own a significant percentage of its stock and will be able to exert significant control over matters of the combined company subject to stockholder approval.

Achieve’s principal stockholders and their affiliates currently beneficially own approximately 85.9% of Achieve’s outstanding voting stock. Therefore, these stockholders have the ability, and may continue to have the ability, to influence Achieve through this ownership position. These stockholders are able to determine some or all matters involving Achieve that require stockholder approval. For example, these stockholders, acting together, are able to control elections of directors, amendments of organizational documents, or approval of any merger, sale of assets, or other major corporate transaction. This control may prevent or discourage unsolicited acquisition proposals or offers for Achieve’s common stock.

Achieve may not have sufficient resources to meet the financial reporting requirements of public companies.

Achieve has to date operated as a private company and as a private company, has not been required to comply with the regulations or incur the costs associated with being a public company, including in particular the financial reporting requirements of a public company. While Achieve intends to use the resources of OncoGenex’s already existing team with respect to public company financial reporting requirements, Achieve’s reporting systems will have to satisfy public company requirements. Complying with these requirements may require increased management time and attention, and potentially require the retention of additional employees, contractors, or third party professionals such as attorneys and accountants, to support the combined company in its financial reporting obligations. If these requirements are not met, or compliance with them diverts management’s attention from other business concerns, they could have a material adverse effect on the combined company’s business, prospects, financial condition and operating results.

Risks Related to the Development of Achieve’s Product Candidates

Results of earlier clinical trials of cytisine are not necessarily predictive of future results, and any advances of cytisine into clinical trials may not have favorable results or receive regulatory approval.

Even if Achieve’s clinical trials are completed as planned, Achieve cannot be certain that their results will be consistent with the results of the earlier clinical trials of cytisine. Positive results in pre-clinical testing and past clinical trials with respect to the safety and efficacy of cytisine do not ensure that results from subsequent clinical trials will also be positive, and Achieve cannot be sure that the results of subsequent clinical trials will replicate the results of prior clinical trials and pre-clinical testing. This failure may cause Achieve to abandon cytisine, which would negatively affect Achieve’s ability to generate any product revenues.

Clinical trials are costly, time consuming and inherently risky, and Achieve may fail to demonstrate safety and efficacy to the satisfaction of applicable regulatory authorities.

Clinical development is expensive, time consuming and involves significant risk. Achieve cannot guarantee that any clinical trial will be conducted as planned or completed on schedule, if at all. A failure of one or more

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clinical trials can occur at any stage of development. Events that may prevent successful or timely completion of clinical development include, but are not limited to:

Any inability to successfully complete clinical development and obtain regulatory approval for cytisine could result in additional costs to Achieve or impair its ability to generate revenue. In addition, if Achieve makes manufacturing or formulation changes to cytisine, Achieve may need to conduct additional pre-clinical trials or the results obtained from such new formulation may not be consistent with previous results obtained. Clinical trial delays could also shorten any periods during which its products have patent protection and may allow competitors to develop and bring products to market before Achieve does, which could impair its ability to successfully commercialize cytisine and may harm its business and results of operations.

Cytisine may cause undesirable side effects or have other properties that could delay or prevent their regulatory approval, limit the commercial viability of an approved label, or result in significant negative consequences following marketing approval, if any.

Undesirable side effects caused by cytisine could cause Achieve or regulatory authorities to interrupt, delay, or terminate clinical trials or even if approved, result in a restrictive label or delay regulatory approval by the FDA or comparable foreign authorities.

Additionally, even if cytisine receives marketing approval, and Achieve or others later identify undesirable side effects caused by cytisine, potentially significant negative consequences could result, including but not limited to:

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Any of these events could prevent Achieve from achieving or maintaining market acceptance of cytisine, even if approved, and could significantly harm its business, results of operations, and prospects.

Achieve’s product development program may not uncover all possible adverse events that patients who take cytisine or its other product candidates may experience. The number of subjects exposed to cytisine or its other product candidates and the average exposure time in the clinical development program may be inadequate to detect rare adverse events, or chance findings, that may only be detected once the product is administered to more patients and for greater periods of time.

Clinical trials by their nature utilize a sample of the potential patient population. However, Achieve cannot be fully assured that rare and severe side effects of cytisine will be uncovered. Such rare and severe side effects may only be uncovered with a significantly larger number of patients exposed to cytisine. If such safety problems occur or are identified after cytisine reaches the market in the United States, or if such safety problems occur or are identified in foreign markets where cytisine is currently marketed, the FDA may require that Achieve amend the labeling of cytisine or recall it, or may even withdraw approval for cytisine.

If the use or misuse of cytisine harms patients, or is perceived to harm patients even when such harm is unrelated to cytisine, Achieve’s regulatory approvals, if any, could be revoked or otherwise negatively impacted and Achieve could be subject to costly and damaging product liability claims. If Achieve is unable to obtain adequate insurance or is required to pay for liabilities resulting from a claim excluded from, or beyond the limits of, its insurance coverage, a material liability claim could adversely affect its financial condition.

The use or misuse of cytisine in clinical trials and the sale of cytisine if marketing approval is obtained, exposes Achieve to the risk of potential product liability claims. Product liability claims might be brought against Achieve by consumers, healthcare providers, pharmaceutical companies or others selling or otherwise coming into contact with its product. There is a risk that cytisine may induce adverse events. If Achieve cannot successfully defend against product liability claims, it could incur substantial liability and costs. During the course of treatment, patients may suffer adverse events for reasons that may be related to cytisine. Such events could subject Achieve to costly litigation, require it to pay substantial amounts of money to injured patients, delay, negatively impact or end its opportunity to receive or maintain regulatory approval to market cytisine, if any, or require Achieve to suspend or abandon its commercialization efforts. Even in a circumstance in which an adverse event is unrelated to cytisine, the investigation into the circumstance may be time-consuming or inconclusive. These investigations may delay Achieve’s regulatory approval process or impact and limit the type of regulatory approvals cytisine receives or maintains. As a result of these factors, a product liability claim, even if successfully defended, could have a material adverse effect on Achieve’s business, financial condition or results of operations.

If Achieve obtains marketing approval for cytisine, it will need to expand its insurance coverage to include the sale of commercial products. There is no way to know if Achieve will be able to continue to obtain product liability coverage and obtain expanded coverage if it requires it, in sufficient amounts to protect it against losses due to liability, on acceptable terms, or at all. Achieve may not have sufficient resources to pay for any liabilities resulting from a claim excluded from, or beyond the limits of, its insurance coverage. Where Achieve has provided indemnities in favor of third parties under its agreements with them, there is also a risk that these third

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parties could incur liability and bring a claim under such indemnities. An individual may bring a product liability claim against Achieve alleging that cytisine causes, or is claimed to have caused, an injury or is found to be unsuitable for consumer use. Any such product liability claims may include allegations of defects in manufacturing, defects in design, a failure to warn of dangers inherent in the product, negligence, strict liability, and a breach of warranties. Claims could also be asserted under state consumer protection acts. Any product liability claim brought against Achieve, with or without merit, could result in:

Product liability claims may subject Achieve to the foregoing and other risks, which could have a material adverse effect on its business, financial condition or results of operations.

The development of Achieve’s product candidate is dependent upon securing sufficient quantities of cytisine from the Laburnum anagyroides plant, which plant grows in a limited number of locations outside of the United States.

The therapeutic component of Achieve’s product candidate, cytisine, is derived from the seeds of the Laburnum anagyroides plant, which grows in the mountains of Southern Europe. Achieve currently secures cytisine exclusively from Sopharma, a Bulgarian third-party supplier. Achieve’s current supply agreement with Sopharma expires on February 1, 2030, unless extended by mutual agreement of Achieve and Sopharma. There can be no assurances that Laburnum anagyroides will continue to grow in sufficient quantities to meet commercial supply requirements or that the countries from which Achieve can secure Laburnum anagyroides will continue to allow the exportation of cytisine. Sopharma currently has planted approximately 600,000 laburnum trees, saplings and seedlings in multiple locations in Central and Eastern Bulgaria. Each tree takes approximately four to five years to reach maturity for harvesting and has a productive life expectancy of 20 to 25 years. Although Sopharma has plans to plant significant numbers of additional trees, there is no guarantee that they will do so or that the trees will produce the anticipated yield of cytisine. In the event Achieve is no longer able to obtain cytisine from Sopharma, or in sufficient quantities, Achieve may not be able to produce its proposed products and its business will be adversely affected.

Achieve’s business may be negatively affected by weather conditions and the availability of natural resources, as well as by climate change.

In recent years, extreme weather events and changing weather patterns such as storms, flooding, drought, and temperature changes, appear to have become more common. The production of cytisine from the Laburnum

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anagyroides plant depends on the availability of natural resources, including sufficient rainfall. Achieve’s exclusive supplier of cytisine, Sopharma, could be adversely affected if it experiences a shortage of fresh water due to droughts or other weather conditions. As a result of such events, Achieve could experience cytisine shortages from Sopharma, all of which could have a material adverse effect on its business, financial condition and results of operations.

In addition, the manufacturing and other operations of Sopharma are located near earthquake fault lines in Sofia, Bulgaria. In the event of a major earthquake, Achieve could experience business interruptions from the disruption of its cytisine supplies, which could have a material adverse effect on Achieve’s business, financial condition and results of operations.

Achieve may conduct clinical trials internationally, which may trigger additional risks.

If Achieve decides to conduct clinical trials in Europe or other countries outside of the United States, Achieve will have additional regulatory requirements that Achieve will have to meet in connection with its manufacturing, distribution, use of data and other matters. The failure of Achieve to meet such regulatory requirements could delay its clinical trials, the approval, if any, of cytisine by the FDA, or the commercialization of cytisine, or result in higher costs or deprive Achieve of potential product revenues.

Achieve may use its financial and human resources to pursue a particular research program or product candidate and fail to capitalize on programs or product candidates that may be more profitable or for which there is a greater likelihood of success.

Because Achieve has limited financial and human resources, it may forego or delay pursuit of opportunities with some programs or product candidates or for other indications that later prove to have greater commercial potential. Achieve’s resource allocation decisions may cause it to fail to capitalize on viable commercial products or more profitable market opportunities. Achieve’s spending on current and future research and development programs and future product candidates for specific indications may not yield any commercially viable products. Achieve may also enter into additional strategic collaboration agreements to develop and commercialize some of its programs and potential product candidates in indications with potentially large commercial markets. If Achieve does not accurately evaluate the commercial potential or target market for a particular product candidate, it may relinquish valuable rights to that product candidate through strategic collaborations, licensing or other royalty arrangements in cases in which it would have been more advantageous for Achieve to retain sole development and commercialization rights to such product candidate, or Achieve may allocate internal resources to a product candidate in a therapeutic area in which it would have been more advantageous to enter into a partnering arrangement.

Risks Related to Regulatory Approval of Cytisine and Other Legal Compliance Matters

If Achieve does not obtain the necessary regulatory approvals in the United States and/or other countries, Achieve will not be able to sell cytisine.

Achieve will need approval from the FDA, to commercialize cytisine in the United States and approvals from similar regulatory authorities in foreign jurisdictions to commercialize cytisine in those jurisdictions. In order to obtain FDA approval of cytisine, Achieve must submit first an IND application and then an NDA to the FDA, demonstrating that cytisine is safe, pure and potent, and effective for its intended use. This demonstration requires significant research including completion of clinical trials. Satisfaction of the FDA’s regulatory requirements typically takes many years, depending upon the type, complexity and novelty of the product candidate and requires substantial resources for research, development and testing. Achieve cannot predict whether its clinical trials will demonstrate the safety and efficacy of cytisine or if the results of any clinical trials will be sufficient to advance to the next phase of development or for approval from the FDA. Achieve also cannot predict whether its research and clinical approaches will result in data that the FDA considers safe and

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effective for the proposed indications of cytisine. The FDA has substantial discretion in the product approval process. The approval process may be delayed by changes in government regulation, future legislation or administrative action or changes in FDA policy that occur prior to or during Achieve’s regulatory review. While Achieve intends to begin a pivotal Phase 3 trial in the first half of 2018, the FDA may require Achieve to conduct additional Phase 3 trials, including if it deems the earlier trials involving cytisine to be insufficient or not available to support a single additional Phase 3 trial. Even if Achieve complies with all FDA requests, the FDA may ultimately reject one or more of its applications. Achieve may never obtain regulatory approval for cytisine. Failure to obtain approval from the FDA or comparable regulatory authorities in foreign jurisdictions to commercialize cytisine will leave Achieve without saleable products and therefore without any source of revenues. In addition, the FDA may require Achieve to conduct additional clinical testing or to perform post-marketing studies, as a condition to granting marketing approval of a product or permit continued marketing, if previously approved. If conditional marketing approval is obtained, the results generated after approval could result in loss of marketing approval, changes in product labeling, and/or new or increased concerns about the side effects or efficacy of a product. The FDA has significant post-market authority, including the explicit authority to require post-market studies and clinical trials, labeling changes based on new safety information and compliance with FDA-approved risk evaluation and mitigation strategies. The FDA’s exercise of its authority has in some cases resulted, and in the future could result, in delays or increased costs during product development, clinical trials and regulatory review, increased costs to comply with additional post-approval regulatory requirements and potential restrictions on sales of approved products. In foreign jurisdictions, the regulatory approval processes generally include the same or similar risks as those associated with the FDA approval procedures described above. Achieve cannot be certain that it will receive the approvals necessary to commercialize cytisine for sale either within or outside the United States.

Even if Achieve obtains regulatory approval for cytisine, Achieve will remain subject to ongoing regulatory requirements in connection with the sale and distribution of cytisine.

Even if cytisine is approved by the FDA or comparable foreign regulatory authorities, Achieve will be subject to ongoing regulatory requirements with respect to manufacturing, labeling, packaging, storage, advertising, promotion, sampling, record-keeping, conduct of post-marketing clinical trials, and submission of safety, efficacy and other post-approval information, including both federal and state requirements in the United States and the requirements of comparable foreign regulatory authorities. Compliance with such regulatory requirements will likely be costly and the failure to comply would likely result in penalties, up to and including, the loss of such approvals from the FDA or comparable foreign regulatory authorities.

Manufacturers and manufacturers’ facilities are required to continuously comply with FDA and comparable foreign regulatory authority requirements, including ensuring that quality control and manufacturing procedures conform to current Good Manufacturing Practices, or cGMP, regulations and corresponding foreign regulatory manufacturing requirements. As such, Achieve, Sopharma and other contract manufacturers, if any, will be subject to continual review and inspections to assess compliance with cGMP and adherence to commitments made in any NDA or marketing authorization application.

Ongoing post-approval monitoring and clinical trial obligations may be costly to Achieve and the failure to meet such obligations may result in the withdrawal of such approvals.

Any regulatory approvals that Achieve receives for cytisine, if any, may be subject to limitations on the approved indicated uses for which cytisine may be marketed or to the conditions of approval, or contain requirements for potentially costly post-marketing testing, including Phase 4 clinical trials, and surveillance to monitor the safety and efficacy of cytisine. Achieve will be required to report adverse reactions and production problems, if any, to the FDA and comparable foreign regulatory authorities. Any new legislation addressing product safety issues could result in delays in product development or commercialization, or increased costs to assure compliance. If its original marketing approval for cytisine was obtained through an accelerated approval pathway, Achieve could be required to conduct a successful post-marketing clinical trial in order to confirm the clinical benefit for

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its products. An unsuccessful post-marketing clinical trial or failure to complete such a trial could result in the withdrawal of marketing approval.

If a regulatory agency discovers previously unknown problems with a product, such as adverse events of unanticipated severity or frequency, or problems with the facility where the product is manufactured, or disagrees with the promotion, marketing or labeling of a product, the regulatory agency may impose restrictions on that product or Achieve, including requiring withdrawal of the product from the market. If Achieve fails to comply with applicable regulatory requirements, a regulatory agency or enforcement authority may, among other things:

Any government investigation of alleged violations of law would be expected to require Achieve to expend significant time and resources in response and could generate adverse publicity. Any failure to comply with ongoing regulatory requirements may significantly and adversely affect its ability to develop and commercialize its products and the value of Achieve and its operating results would be adversely affected.

Achieve may be subject, directly or indirectly, to federal and state healthcare fraud and abuse laws, false claims laws, and health information privacy and security laws. If Achieve is unable to comply, or has not fully complied, with such laws, it could face substantial penalties.

If Achieve obtains FDA approval for any of cytisine and begins commercializing it in the United States, Achieve’s operations may be subject to various federal and state fraud and abuse laws, including, without limitation, the federal Anti-Kickback Statute, the federal False Claims Act, and physician sunshine laws and regulations. These laws may impact, among other things, its proposed sales, marketing, and education programs. In addition, Achieve may be subject to patient privacy regulation by both the federal government and the states in which Achieve conduct its business. The laws that may affect its ability to operate include:

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Because of the breadth of these laws and the narrowness of the statutory exceptions and safe harbors available, it is possible that some of Achieve’s business activities could be subject to challenge under one or more of such laws. In addition, recent health care reform legislation has strengthened these laws. For example, the Health Care Reform Law, among other things, amends the intent requirement of the federal anti-kickback and criminal healthcare fraud statutes. A person or entity no longer needs to have actual knowledge of this statute or specific intent to violate it. Moreover, the Health Care Reform Law provides that the government may assert that a claim including items or services resulting from a violation of the federal anti-kickback statute constitutes a false or fraudulent claim for purposes of the False Claims Act.

If Achieve’s operations are found to be in violation of any of the laws described above or any other governmental regulations that apply to Achieve, Achieve may be subject to penalties, including civil and criminal penalties, damages, fines, exclusion from participation in government health care programs, such as Medicare and Medicaid, imprisonment, and the curtailment or restructuring of its operations, any of which could adversely affect its ability to operate Achieve’s business and its results of operations.

Healthcare legislative and executive reform measures may have a material adverse effect on Achieve’s business, financial condition or results of operations.

In the United States, there have been and continue to be a number of legislative initiatives to contain healthcare costs. For example, in March 2010, the Health Care Reform Law was passed, which substantially changes the way health care is financed by both governmental and private insurers, and significantly impacts the U.S. pharmaceutical industry. The Health Care Reform Law, among other things, addresses a new methodology by which rebates owed by manufacturers under the Medicaid Drug Rebate Program are calculated for products that are inhaled, infused, instilled, implanted, or injected, increases the minimum Medicaid rebates owed by manufacturers under the Medicaid Drug Rebate Program and extends the rebate program to individuals enrolled in Medicaid managed care organizations, establishes annual fees and taxes on manufacturers of specified branded prescription products, and promotes a new Medicare Part D coverage gap discount program.

On January 20, 2017, President Donald Trump issued an Executive Order to initiate the repeal of the Health Care Reform Law and Achieve expects that additional state and federal healthcare measures under the Trump administration will be adopted in the future, any of which could limit the amounts that federal and state governments will pay for healthcare products and services, which could result in reduced demand or lower pricing for cytisine, or additional pricing pressures. Currently, the Health Care Reform Law provides coverage for smoking cessation-related activities, including two counseling attempts for smoking cessation per year and

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prescription drugs for smoking cessation, but not over-the-counter treatments. If these provisions are repealed, in whole or in part, Achieve’s business, financial condition, or results of operations could be negatively affected.

The United Kingdom is currently a member state of the European Union. However, the United Kingdom has signaled its intention to withdraw from the European Union (commonly known as BREXIT). If BREXIT, which is likely to occur in 2019, does occur, the United Kingdom will no longer be a member state within the European Union. Since a significant portion of the regulatory framework in the United Kingdom is derived from the regulations of the European Union, BREXIT could materially change the regulatory framework applicable to the approval of cytisine, which could have a material adverse effect on Achieve and its operations. BREXIT may also result in other significant regulatory and legislative changes in the United Kingdom, which could, for example, affect the pricing of pharmaceutical products in the United Kingdom, which could in turn result in diminished performance for Achieve. Even if the substance of regulatory changes resulting from BREXIT does not have a significant impact on Achieve’s operations, it is reasonable to expect that Achieve would incur potentially significant costs in connection with complying with any new regulations. Further, the European Medicines Agency is currently located in the United Kingdom. It is possible that BREXIT would result in the relocation of the European Medicines Agency or disruption to the European Medicines Agency’s review process, either of which could have an adverse effect on Achieve’s operations in the United Kingdom and the European Union.

BREXIT may also have adverse effects on potential customers and collaborators of Achieve, which could indirectly have an adverse effect on Achieve.

Risks Related to Achieve’s Business Operations

It is difficult to evaluate Achieve’s current business, predict Achieve’s future prospects and forecast Achieve’s financial performance and growth.

To date Achieve’s business activities have been focused primarily on the development and regulatory approval of cytisine and its various alternative forms. Although Achieve has not generated revenue to date, Achieve expects that, after any regulatory approval, any receipt of revenue will be attributable to sales of cytisine, primarily in the United States, the European Union (including the United Kingdom) and Japan. Because Achieve devotes substantially all of its resources to the development of cytisine and relies on cytisine as its sole source of potential revenue for the foreseeable future, any factors that negatively impact this product, or result in decreasing product sales, would materially and adversely affect Achieve’s business, financial condition and results of operations.

Achieve’s future success depends in part on its ability to attract, retain, and motivate other qualified personnel.

Achieve currently has a limited number of personnel. Achieve expects to need additional scientific, technical, operational, financial and other personnel. Recruiting and retaining other qualified employees, consultants, and advisors for Achieve’s business will be important to achieve success. Achieve may not be able to attract and retain personnel on acceptable terms, if at all, given the competition among numerous pharmaceutical and biotechnology companies for individuals with similar skill sets. In addition, failure to succeed in development and commercialization of cytisine may make it more challenging to recruit and retain qualified personnel. The inability to recruit and retain qualified personnel, or the loss of the services of its current personnel may impede the progress of Achieve’s research, development, and commercialization objectives and would negatively impact Achieve’s ability to succeed in its product development strategy.

Achieve will need to expand its organization and Achieve may experience difficulties in managing this growth, which could disrupt its operations.

Its management may need to divert a disproportionate amount of its attention away from its day-to-day activities and devote a substantial amount of time to managing these growth activities. Achieve may not be able to

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effectively manage the expansion of its operations, which may result in weaknesses in its infrastructure, operational mistakes, loss of business opportunities, loss of employees, and reduced productivity among remaining employees. Achieve’s expected growth could require significant capital expenditures and may divert financial resources from other projects, such as the development of additional product candidates. If its management is unable to effectively manage its growth, its expenses may increase more than expected, its ability to generate and/or grow revenue could be reduced and Achieve may not be able to implement its business strategy. Achieve’s future financial performance and its ability to commercialize product candidates and compete effectively will depend, in part, on its ability to effectively manage any future growth.

Risks Related to Achieve’s Reliance on Third Parties

Achieve expects to continue to rely on third parties to manufacture cytisine for use in clinical trials, and Achieve intends to exclusively rely on Sopharma to produce and process cytisine, if approved. Achieve’s commercialization of cytisine could be stopped, delayed or made less profitable if Sopharma fails to obtain approval of government regulators, fails to provide Achieve with sufficient quantities of product, or fails to do so at acceptable quality levels or prices.

Achieve does not currently have nor does it currently plan to develop the infrastructure or capability internally to manufacture its clinical supplies for use in the conduct of Achieve’s clinical trials, and Achieve lacks the resources and the capability to manufacture cytisine on a clinical or commercial scale. Achieve currently exclusively relies on Sopharma to manufacture cytisine for use in clinical trials and plans to continue relying on Sopharma to manufacture cytisine on a commercial scale, if approved.

Achieve’s reliance on Sopharma exposes Achieve to the following additional risks:

Each of these risks could delay Achieve’s clinical trials, the approval, if any of cytisine by the FDA or the commercialization of cytisine or result in higher costs or deprive Achieve of potential product revenue.

The manufacture of medical products is complex and requires significant expertise and capital investment, including the development of advanced manufacturing techniques and process controls. Manufacturers of medical products often encounter difficulties in production, particularly in scaling up and validating initial production and absence of contamination. These problems include difficulties with production costs and yields, quality control, including stability of the product, quality assurance testing, operator error, shortages of qualified

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personnel, as well as compliance with strictly enforced federal, state and foreign regulations. Furthermore, if contaminants are discovered in the supply of cytisine or in the Sopharma manufacturing facilities, such manufacturing facilities may need to be closed for an extended period of time to investigate and remedy the contamination. Achieve cannot be assured that any stability or other issues relating to the manufacture of cytisine will not occur in the future. Additionally, Sopharma may experience manufacturing difficulties due to resource constraints or as a result of labor disputes or political instability in the countries in which Sopharma conducts its operations. If Sopharma were to encounter any of these difficulties, or otherwise fail to comply with their contractual obligations, Achieve’s ability to provide its product candidates to patients in clinical trials could be delayed or suspended. Any delay or interruption in the supply of clinical trial supplies could delay the completion of clinical trials, increase the costs associated with maintaining clinical trial programs and, depending upon the period of delay, require Achieve to commence new clinical trials at additional expense or terminate clinical trials completely. Similar political instability could also harm the commercial production and supply of cytisine in the event that cytisine is ultimately approved for commercial sale.

Achieve relies on third parties to conduct its clinical trials and perform other services. If these third parties do not successfully perform and comply with regulatory requirements, Achieve may not be able to successfully complete clinical development, obtain regulatory approval or commercialize cytisine and its business could be substantially harmed.

Achieve plans to rely upon third-party CROs to conduct, monitor and manage its ongoing clinical programs. Achieve relies on these parties for execution of clinical trials and manages and controls only some aspects of their activities. Achieve remains responsible for ensuring that each of its trials is conducted in accordance with the applicable protocol, legal, regulatory, and scientific standards and its reliance on the CROs does not relieve Achieve of its regulatory responsibilities. Achieve and its CROs and other vendors are required to comply with all applicable laws, regulations and guidelines, including those required by the FDA and comparable foreign regulatory authorities for all of its product candidates in clinical development. If Achieve or any of its CROs or vendors fail to comply with applicable laws, regulations and guidelines, the results generated in its clinical trials may be deemed unreliable and the FDA or comparable foreign regulatory authorities may require Achieve to perform additional clinical trials before approving its marketing applications. Achieve cannot be assured that its CROs and other vendors will meet these requirements, or that upon inspection by any regulatory authority, such regulatory authority will determine that efforts, including any of its clinical trials, comply with applicable requirements. Its failure to comply with these laws, regulations and guidelines may require Achieve to repeat clinical trials, which would be costly and delay the regulatory approval process.

If any of Achieve’s relationships with these third-party CROs terminate, Achieve may not be able to enter into arrangements with alternative CROs in a timely manner or do so on commercially reasonable terms. In addition, Achieve’s CROs may not prioritize Achieve’s clinical trials relative to those of other customers and any turnover in personnel or delays in the allocation of CRO employees by the CRO may negatively affect its clinical trials. If CROs do not successfully carry out their contractual duties or obligations or meet expected deadlines, continued development of cytisine may be delayed or terminated and Achieve may not be able to meet its current plans with respect to cytisine. CROs may also involve higher costs than anticipated, which could negatively affect Achieve’s financial condition and operations.

Achieve may not be able to establish or maintain the third-party relationships that are necessary to develop or potentially commercialize cytisine.

Achieve’s business plan relies heavily on third party collaborators, partners, licensees, clinical research organizations, clinical investigators, vendors or other third parties to support its research and development efforts and to conduct clinical trials for cytisine. Achieve cannot guarantee that it will be able to successfully negotiate agreements for, or maintain relationships with, these third parties on a commercially reasonable basis, if at all. If Achieve fails to establish or maintain such third-party relationships as anticipated, its business could be adversely effected.

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Achieve may be unable to realize the potential benefits of any collaborations which it may enter into with other companies for the development and commercialization of cytisine.

Achieve may enter into a collaboration with third parties concerning the development and/or commercialization of cytisine; however, there is no guarantee that any such collaboration will be successful. Collaborations may pose a number of risks, including:

As a result, a collaboration may not result in the successful development or commercialization of cytisine.

Achieve enters into various contracts in the normal course of its business in which Achieve indemnifies the other party to the contract. In the event Achieve has to perform under these indemnification provisions, it could have a material adverse effect on its business, financial condition and results of operations.

In the normal course of business, Achieve enters into academic, commercial, service, collaboration, licensing, consulting and other agreements that contain indemnification provisions. With respect to Achieve’s academic and other research agreements, Achieve typically indemnifies the institution and related parties from losses arising from claims relating to the products, processes or services made, used, sold or performed pursuant to the agreements for which Achieve has secured licenses, and from claims arising from Achieve’s or its sublicensees’ exercise of rights under the agreement. With respect to Achieve’s collaboration agreements, Achieve indemnifies its collaborators from any third-party product liability claims that could result from the production, use or consumption of the product, as well as for alleged infringements of any patent or other intellectual property right by a third party. With respect to consultants, Achieve indemnifies them from claims arising from the good faith performance of their services.

Should Achieve’s obligation under an indemnification provision exceed applicable insurance coverage or if Achieve were denied insurance coverage, Achieve’s business, financial condition and results of operations could be adversely affected. Similarly, if Achieve is relying on a collaborator to indemnify Achieve and the

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collaborator is denied insurance coverage or the indemnification obligation exceeds the applicable insurance coverage, and if the collaborator does not have other assets available to indemnify Achieve, its business, financial condition and results of operations could be adversely affected.

Risks Related to Commercialization of Cytisine

Achieve faces substantial competition and its competitors may discover, develop or commercialize products faster or more successfully than Achieve.

The development and commercialization of new products is highly competitive. Achieve faces competition from major pharmaceutical companies, specialty pharmaceutical companies, biotechnology companies, universities and other research institutions worldwide with respect to cytisine and the other product candidates that it may seek to develop or commercialize in the future. Achieve is aware that many companies have therapeutics marketed or in development for smoking cessation, including, Pfizer Inc., GlaxoSmithKline Plc, Merck & Co., Novartis, Invion, Embera Neurotherapeutics, Redwood Scientific Technologies, Inc., 22nd Century Group, Inc., Quit4Good, Chrono Therapeutics, NAL Pharmaceuticals, Selecta Biosciences, Aradigm and others.

Many of Achieve’s competitors have substantially greater financial, name recognition, manufacturing, marketing, research, technical and other resources than Achieve. Additional mergers and acquisitions in the biotechnology and pharmaceutical industries may result in even more resources being concentrated in its competitors. Further, Achieve’s competitors may develop new products that are safer, more effective or more cost-efficient than cytisine. Large pharmaceutical companies in particular have extensive expertise in pre-clinical and clinical testing and in obtaining regulatory approvals for products. In addition, academic institutions, government agencies, and other public and private organizations conducting research may seek patent protection with respect to potentially competitive products or technologies. These organizations may also establish exclusive collaborative or licensing relationships with Achieve’s competitors. Failure of cytisine to effectively compete against established treatment options or in the future with new products currently in development would harm Achieve’s business, financial condition, results of operations and prospects.

The commercial success of cytisine will depend upon the degree of market acceptance by physicians, patients, third-party payors, and others in the medical community. Failure to obtain or maintain adequate reimbursement or insurance coverage for products, if any, could limit Achieve’s ability to market cytisine and decrease its ability to generate revenue.

Even with the approvals from the FDA and comparable foreign regulatory authorities, the commercial success of cytisine will depend in part on the health care providers, patients, and third-party payors accepting cytisine as medically useful, cost-effective, and safe. Cytisine may not gain market acceptance by physicians, patients and third-party payors. The degree of market acceptance of cytisine will depend on a number of factors, including but not limited to:

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Even if cytisine displays a favorable efficacy and safety profile upon approval, market acceptance of cytisine remains uncertain. Efforts to educate the medical community and third-party payors on the benefits of cytisine, if any, may require significant investment and resources and may never be successful. Additionally, third-party payors, including governmental and private insurers, may also encourage the use of generic products instead of cytisine, which require a prescription. If its products fail to achieve an adequate level of acceptance by physicians, patients, third-party payors, and other health care providers, Achieve will not be able to generate sufficient revenue to become or remain profitable.

The pricing, coverage, and reimbursement of cytisine, if any, must be sufficient to support Achieve’s commercial efforts and other development programs and the availability and adequacy of coverage and reimbursement by third-party payors, including governmental and private insurers, are essential for most patients to be able to afford treatments. Sales of cytisine, if any, will depend substantially, both domestically and abroad, on the extent to which the costs of cytisine will be paid for or reimbursed by health maintenance, managed care, pharmacy benefit and similar healthcare management organizations, or government payors and private payors. If coverage and reimbursement are not available, or are available only in limited amounts, Achieve may have to subsidize or provide cytisine for free or Achieve may not be able to successfully commercialize cytisine.

In addition, there is significant uncertainty related to the insurance coverage and reimbursement for newly approved products. In the United States, the principal decisions about coverage and reimbursement for new products are typically made by CMS, an agency within the U.S. Department of Health and Human Services, as CMS decides whether and to what extent a new product will be covered and reimbursed under Medicare. Private payors tend to follow the coverage reimbursement policies established by CMS to a substantial degree. It is difficult to predict what CMS will decide with respect to reimbursement for novel product candidates such as cytisine and what reimbursement codes cytisine may receive if approved.

Outside the United States, selling operations are generally subject to extensive governmental price controls and other price-restrictive regulations, and Achieve believes the increasing emphasis on cost-containment initiatives in Europe, Canada, and other countries has and will continue to put pressure on the pricing and usage of products. In many countries, the prices of products are subject to varying price control mechanisms as part of national health systems. Price controls or other changes in pricing regulation could restrict the amount that Achieve is able to charge for its products, if any. Accordingly, in markets outside the United States, the potential revenue may be insufficient to generate commercially reasonable revenue and profits.

Moreover, increasing efforts by governmental and private payors in the United States and abroad to limit or reduce healthcare costs may result in restrictions on coverage and the level of reimbursement for new products and, as a result, they may not cover or provide adequate payment for its products. Achieve expects to experience pricing pressures in connection with products due to the increasing trend toward managed healthcare, including the increasing influence of health maintenance organizations and additional legislative changes. The downward pressure on healthcare costs in general, particularly prescription products has and is expected to continue to increase in the future. As a result, profitability of cytisine, if any, may be more difficult to achieve even if regulatory approval is received.

Sopharma may breach its supply agreement with Achieve and sell cytisine into Achieve’s territories or permit third parties to export cytisine into Achieve’s territories and negatively affect Achieve’s commercialization efforts of its products in its territories.

Achieve is currently dependent on the exclusivity provisions of its supply agreement with Sopharma to conduct its business and to prevent Sopharma from competing, directly and indirectly, with Achieve in the United States and Western Europe. If Sopharma were to breach the exclusivity provisions of the supply agreement with Achieve and sell or distribute cytisine directly into Achieve’s territories or permit third parties to export cytisine into Achieve’s territories, among other things, the increase in competition within Achieve’s anticipated markets could have a material adverse effect on Achieve’s business, results of operations and financial condition.

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The illegal distribution and sale by third parties of counterfeit versions of cytisine, stolen products, or alternative third party distribution and sale of cytisine could have a negative impact on Achieve’s financial performance or reputation.

Cytisine is not patentable in the United States as it is a naturally occurring substance. As such, third parties are able to manufacture, sell or distribute cytisine without royalties or other payments to Achieve and compete with Achieve’s products in the United States and potentially worldwide and negatively impact Achieve’s commercialization efforts of its products. Other than regulatory exclusivity or other limitations, there may be little to nothing to stop these third parties from manufacturing, selling or distributing cytisine. Because Achieve has no ability to set rigorous safety standards or control processes over third party manufacturers, sellers or distributors of cytisine, excluding Sopharma, these formulations of cytisine may be unsafe or cause adverse effects to patients and negatively impact the reputation of cytisine as a safe and effective smoking cessation aid.

Third parties could illegally distribute and sell counterfeit versions of cytisine, especially on online marketplaces, which do not meet the rigorous manufacturing and testing standards under cGMP. Counterfeit products are frequently unsafe or ineffective, and may even be life-threatening. Counterfeit medicines may contain harmful substances, the wrong dose of the active pharmaceutical ingredient or no active pharmaceutical ingredients at all. However, to distributors and users, counterfeit products may be visually indistinguishable from the authentic version.

Reports of adverse reactions to counterfeit products, increased levels of counterfeiting, or unsafe cytisine products could materially affect patient confidence in Achieve’s cytisine product. It is possible that adverse events caused by unsafe counterfeit or other non-Achieve cytisine products will mistakenly be attributed to Achieve’s cytisine product. In addition, thefts of inventory at warehouses, plants or while in-transit, which are not properly stored and which are sold through unauthorized channels could adversely impact patient safety, Achieve’s reputation, and Achieve’s business. Public loss of confidence in the integrity in cytisine as a result of counterfeiting, theft, or improper manufacturing processes could have a material adverse effect on Achieve’s business, results of operations, and financial condition.

It is illegal to sell unapproved prescription medicines in the United States. Sopharma’s cytisine brand, Tabex, is currently approved for sale in certain Central and Eastern European countries. Cytisine has not yet received a marketing approval from the FDA or the European Medicines Agency, and Achieve intends to conduct the requisite clinical trials to obtain approval for the marketing of cytisine in the United States and in Europe. Achieve is aware that products purporting to be Tabex are available, via third party internet sites, for importation in the United States and European Union. Achieve has no control over the authenticity of products purchased through these sites, which may be counterfeit or sourced from distributors in Central and Eastern Europe without authorization to sell into the United States or European Union.

Achieve may attempt to form collaborations in the future with respect to cytisine, but it may not be able to do so, which may cause it to alter its development and commercialization plans.

Achieve may attempt to form strategic collaborations, create joint ventures or enter into licensing arrangements with third parties with respect to its programs that it believes will complement or augment its existing business. Achieve may face significant competition in seeking appropriate strategic collaborators, and the negotiation process to secure appropriate terms is time consuming and complex. Achieve may not be successful in its efforts to establish such a strategic collaboration for cytisine on terms that are acceptable to it, or at all. This may be because cytisine may be deemed to be at too early of a stage of development for collaborative effort, its research and development pipeline may be viewed as insufficient, the competitive or intellectual property landscape may be viewed as too intense or risky, or cytisine’s patent protection insufficient, and/or third parties may not view cytisine as having sufficient potential for commercialization, including the likelihood of an adequate safety and efficacy profile.

Any delays in identifying suitable collaborators and entering into agreements to develop and/or commercialize cytisine could delay the development or commercialization of cytisine, which may reduce its competitiveness

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even if it reaches the market. Absent a strategic collaborator, Achieve would need to undertake development and/or commercialization activities at its own expense. If Achieve elects to fund and undertake development and/or commercialization activities on its own, it may need to obtain additional expertise and additional capital, which may not be available to it on acceptable terms or at all. If Achieve is unable to do so, it may not be able to develop its product candidates or bring them to market and its business may be materially and adversely affected.

Achieve may not be successful in any efforts to identify, license, discover, develop, or commercialize additional product candidates.

Although a substantial amount of Achieve’s effort will focus on clinical testing, approval, and potential commercialization of cytisine, Achieve’s sole product candidate, the success of Achieve’s business is also expected to depend in part upon its ability to identify, license, discover, develop, or commercialize additional product candidates. Research programs to identify new product candidates require substantial technical, financial, and human resources. Achieve may focus its efforts and resources on potential programs or product candidates that ultimately prove to be unsuccessful. Achieve’s research programs or licensing efforts may fail to yield additional product candidates for clinical development and commercialization for a number of reasons, including but not limited to the following:

If any of these events occur, Achieve may be forced to abandon its development efforts for a program or programs, or Achieve may not be able to identify, license, discover, develop, or commercialize additional product candidates, which would have a material adverse effect on its business, financial condition or results of operations and could potentially cause Achieve to cease operations.

Risks Related to Achieve’s Intellectual Property

Achieve may not be successful in obtaining or maintaining necessary rights to cytisine, product compounds and processes for its development pipeline through acquisitions and in-licenses.

Presently, Achieve has rights to the intellectual property through trade secrets, licenses from third parties and patent applications that Achieve owns. Achieve’s product candidates may require specific formulations to work effectively and efficiently and these rights may be held by others. Achieve may be unable to acquire or in-license any compositions, methods of use, processes or other third-party intellectual property rights from third parties

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that it identifies. The licensing and acquisition of third-party intellectual property rights is a competitive area, and a number of more established companies are also pursuing strategies to license or acquire third-party intellectual property rights that Achieve may consider attractive. These established companies may have a competitive advantage over Achieve due to their size, cash resources and greater clinical development and commercialization capabilities. In addition, companies that perceive Achieve to be a competitor may be unwilling to assign or license rights to it. Achieve also may be unable to license or acquire third-party intellectual property rights on terms that would allow it to make an appropriate return on its investment. If Achieve is unable to successfully obtain rights to third-party intellectual property rights, its business, financial condition and prospects for growth could suffer.

If Achieve is unable to maintain effective proprietary rights for its product candidates or any future product candidates, Achieve may not be able to compete effectively in its proposed markets.

Achieve currently relies primarily on trade secret protection and on confidentiality agreements to protect proprietary know-how that is not patentable or that Achieve elects not to patent, processes for which patents are difficult to enforce and any other elements of its product candidate discovery and development processes that involve proprietary know-how, information or technology that is not covered by patents. Trade secrets can be difficult to protect, however, and even where they are protected they generally provide less intellectual property protection to the holder of the trade secret than to a holder of a patent. Achieve seeks to protect its proprietary technology and processes, in part, by entering into confidentiality agreements with its employees, consultants, scientific advisors, and contractors. Achieve also seeks to preserve the integrity and confidentiality of its data and trade secrets by maintaining physical security of its premises and physical and electronic security of its information technology systems. While Achieve has confidence in these individuals, organizations and systems, agreements or security measures may be breached, and Achieve may not have adequate remedies for any breach. In addition, its trade secrets may otherwise become known or be independently discovered by competitors.

Although Achieve expects all of its employees and consultants to assign their inventions to Achieve, and all of its employees, consultants, advisors, and any third parties who have access to its proprietary know-how, information, or technology to enter into confidentiality agreements, Achieve cannot provide any assurances that all such agreements have been duly executed or that its trade secrets and other confidential proprietary information will not be disclosed or that competitors will not otherwise gain access to its trade secrets or independently develop substantially equivalent information and techniques. Misappropriation or unauthorized disclosure of Achieve’s trade secrets could impair its competitive position and may have a material adverse effect on its business, financial condition or results of operations. Additionally, if the steps taken to maintain its trade secrets are deemed inadequate, Achieve may have insufficient recourse against third parties for misappropriating the trade secret.

Third-party claims of intellectual property infringement may prevent or delay Achieve’s development and commercialization efforts.

Achieve is currently developing cytisine for smoking cessation. Achieve’s commercial success depends in part on its ability to develop, manufacture, market and sell its product candidates and use its proprietary technology without infringing the patent rights of third parties. Achieve is not aware of any patents or patent applications that would prevent the development, manufacture or marketing of cytisine for smoking cessation.

Achieve is aware of U.S. and foreign patents and pending patent applications owned by third parties that cover certain other therapeutic uses of cytisine. Achieve is currently monitoring these patents and patent applications. Achieve may in the future pursue available proceedings in the U.S. and foreign patent offices to challenge the validity of these patents and patent applications. In addition, or alternatively, Achieve may consider whether to seek to negotiate a license of rights to technology covered by one or more of such patents and patent applications for these certain additional therapeutic uses. If any third party patents or patent applications cover its product candidates or technologies in other therapeutic uses, Achieve may not be free to manufacture or market its

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product candidates for additional therapeutic uses, absent such a license, which may not be available to Achieve on commercially reasonable terms, or at all.

It is also possible that Achieve has failed to identify relevant third-party patents or applications. For example, applications filed before November 29, 2000 and applications filed after that date that will not be filed outside the United States remain confidential until patents issue. Moreover, it is difficult for industry participants, including Achieve, to identify all third-party patent rights that may be relevant to its product candidates and technologies because patent searching is imperfect due to differences in terminology among patents, incomplete databases and the difficulty in assessing the meaning of patent claims. Achieve may fail to identify relevant patents or patent applications or may identify pending patent applications of potential interest but incorrectly predict the likelihood that such patent applications may issue with claims of relevance to its technology. In addition, Achieve may be unaware of one or more issued patents that would be infringed by the manufacture, sale or use of a current or future product candidate, or Achieve may incorrectly conclude that a third-party patent is invalid, unenforceable or not infringed by its activities. Additionally, pending patent applications that have been published can, subject to specified limitations, be later amended in a manner that could cover Achieve’s technologies, its product candidates or the use of its product candidates.

There have been many lawsuits and other proceedings involving patent and other intellectual property rights in the pharmaceutical industries, including patent infringement lawsuits, interferences, oppositions, and reexamination proceedings before the USPTO and corresponding foreign patent offices. U.S. and foreign issued patents and pending patent applications, which are owned by third parties, exist in the fields in which Achieve is developing product candidates. As the biotechnology and pharmaceutical industries expand and more patents are issued, the risk increases that its product candidates may be subject to claims of infringement of the patent rights of third parties.

Parties making claims against Achieve may obtain injunctive or other equitable relief, which could effectively block its ability to further develop and commercialize one or more of its product candidates. Defense of these claims, regardless of their merit, would involve substantial litigation expense and would be a substantial diversion of employee resources from its business. In the event of a successful claim of infringement against Achieve, Achieve may have to pay substantial damages, including treble damages and attorneys’ fees for willful infringement, pay royalties, redesign its infringing products or obtain one or more licenses from third parties, which may be impossible or require substantial time and monetary expenditure.

Achieve intends to rely on patent rights for certain aspects of its product candidates and certain future product candidates. If Achieve is unable to obtain or maintain an adequate proprietary position from this approach, Achieve may not be able to compete effectively in its markets.

Although Achieve relies or will rely primarily on trade secret protection as part of its intellectual property rights strategies, Achieve also intends to rely on patent rights to protect certain aspects of its technologies and upon the patent rights of third parties from which it licenses certain of its technologies.

Achieve has sought to protect its proprietary position by filing patent applications in the United Kingdom and intends to file patent applications in the United States related to future product candidates. This process is expensive and time consuming, and Achieve may not be able to file and prosecute all necessary or desirable patent applications at a reasonable cost or in a timely manner or at all. It is also possible that Achieve will fail to identify patentable aspects of its research and development output before it is too late to obtain patent protection.

The patent position of pharmaceutical companies generally is highly uncertain and involves complex legal and factual questions for which legal principles remain unsolved. The patent applications that Achieve owns may fail to result in issued patents with claims that cover its product candidates in the United States or in other foreign countries. There is no assurance that all potentially relevant prior art relating to its patent applications or its patents (once issued) has been found, which can invalidate a patent or prevent a patent from issuing from a

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pending patent application. Even if patents do successfully issue, and even if such patents cover Achieve’s future product candidates, third parties may challenge their validity, enforceability, or scope, which may result in such patents being narrowed, found unenforceable or invalidated. Furthermore, even if they are unchallenged, Achieve’s patents and patent applications may not adequately protect its intellectual property, provide exclusivity for its future product candidates, or prevent others from designing around the Achieve claims. Any of these outcomes could impair Achieve’s ability to prevent competition from third parties, which may have an adverse impact on its business.

Achieve cannot offer any assurances about which, if any, patents will issue, the breadth of any such patent or whether any issued patents will be found invalid and unenforceable or will be threatened by third parties. Any successful opposition to these patents or any other patents owned by or licensed to Achieve after patent issuance could deprive Achieve of rights necessary for the successful commercialization of any future product candidates that Achieve may develop. Further, if Achieve encounters delays in regulatory approvals, the period of time during which Achieve could market a future product candidate under patent protection could be reduced.

If Achieve cannot obtain and maintain effective protection of exclusivity from its regulatory efforts and intellectual property rights, including patent protection or data exclusivity, for its product candidates, Achieve may not be able to compete effectively and its business and results of operations would be harmed.

Changes in patent law could diminish the value of patents in general, thereby impairing Achieve’s ability to protect its product candidates.

Obtaining and enforcing patents in the biopharmaceutical industry involves both technological and legal complexity, and is therefore costly, time-consuming, and inherently uncertain. In addition, the United States has recently enacted and is currently implementing wide-ranging patent reform legislation. Recent U.S. Supreme Court rulings have narrowed the scope of patent protection available in certain circumstances and weakened the rights of patent owners in certain situations. In addition to increasing uncertainty with regard to Achieve’s ability to obtain patents in the future, this combination of events has created uncertainty with respect to the value of patents once obtained, if any. Depending on decisions by the U.S. Congress, the federal courts and the U.S. Patent and Trademark Office, or the USPTO, the laws and regulations governing patents could change in unpredictable ways that would weaken Achieve’s ability to obtain new patents or to enforce its existing patents and patents that Achieve might obtain in the future.

In a recent case, Assoc. for Molecular Pathology v. Myriad Genetics, Inc. , the U.S. Supreme Court held that certain claims to naturally-occurring substances are not patentable. Cytisine is a naturally-occurring product and is not patentable. Achieve’s intellectual property strategy involves novel formulations of cytisine and there is no guarantee that such patents will be issued or if issued, will be broad enough to prevent competitors from developing competing cytisine products. Although Achieve does not believe that any patents that may issue from Achieve’s pending patent applications directed at its product candidates, if issued in their currently pending forms, as well as patent rights licensed by Achieve, will be found invalid based on this decision, Achieve cannot predict how future decisions by the courts, the U.S. Congress or the USPTO may impact the value of Achieve’s patent rights. There could be similar changes in the laws of foreign jurisdictions that may impact the value of Achieve’s patent rights or its other intellectual property rights.

Achieve may be subject to claims that its employees, consultants, or independent contractors have wrongfully used or disclosed confidential information of third parties or that its employees have wrongfully used or disclosed alleged trade secrets of their former employers.

Achieve employs individuals who were previously employed at other biotechnology or pharmaceutical companies. Although Achieve has written agreements and makes every effort to ensure that its employees, consultants, and independent contractors do not use the proprietary information or intellectual property rights of others in their work for Achieve, Achieve may in the future be subject to any claims that its employees,

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consultants, or independent contractors have wrongfully used or disclosed confidential information of third parties. Litigation may be necessary to defend against these claims. If Achieve fails in defending any such claims, in addition to paying monetary damages, Achieve may lose valuable intellectual property rights or personnel, which could adversely impact its business. Even if Achieve is successful in defending against such claims, litigation could result in substantial costs and be a distraction to management and other employees.

Risks Related to the Combined Company

In determining whether you should approve the merger, the issuance of shares of OncoGenex common stock and other matters related to the merger, as the case may be, you should carefully read the following risk factors in addition to the risks described above.

The combined company’s stock price is expected to be volatile, and the market price of its common stock may drop following the merger.

The market price of the combined company’s common stock following the merger could be subject to significant fluctuations following the merger. Market prices for securities of early-stage pharmaceutical, biotechnology and other life sciences companies have historically been particularly volatile. Some of the factors that may cause the market price of the combined company’s common stock to fluctuate include:

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Moreover, the stock markets in general have experienced substantial volatility that has often been unrelated to the operating performance of individual companies. These broad market fluctuations may also adversely affect the trading price of the combined company’s common stock.

In the past, following periods of volatility in the market price of a company’s securities, stockholders have often instituted class action securities litigation against those companies. Such litigation, if instituted, could result in substantial costs and diversion of management attention and resources, which could significantly harm the combined company’s profitability and reputation.

The combined company will incur costs and demands upon management as a result of complying with the laws and regulations affecting public companies.

The combined company will incur significant legal, accounting and other expenses that Achieve did not incur as a private company, including costs associated with public company reporting requirements. The combined company will also incur costs associated with corporate governance requirements, including requirements under the Sarbanes-Oxley Act, as well as new rules implemented by the SEC and The NASDAQ Stock Market LLC. These rules and regulations are expected to increase the combined company’s legal and financial compliance costs and to make some activities more time-consuming and costly. These rules and regulations may also make it difficult and expensive for the combined company to obtain directors’ and officers’ liability insurance. As a result, it may be more difficult for the combined company to attract and retain qualified individuals to serve on the combined company’s board of directors or as executive officers of the combined company, which may adversely affect investor confidence in the combined company and could cause the combined company’s business or stock price to suffer.

OncoGenex and Achieve do not anticipate that the combined company will pay any cash dividends in the foreseeable future.

The current expectation is that the combined company will retain its future earnings, if any, to fund the development and growth of the combined company’s business. As a result, capital appreciation, if any, of the common stock of the combined company will be your sole source of gain, if any, for the foreseeable future.

Future sales of shares by existing stockholders could cause the combined company’s stock price to decline.

If existing stockholders of OncoGenex and Achieve sell, or indicate an intention to sell, substantial amounts of the combined company’s common stock in the public market after legal restrictions on resale discussed in this proxy statement/prospectus/information statement lapse, the trading price of the common stock of the combined

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company could decline. Based on shares outstanding as of December 31, 2016 and shares expected to be issued upon completion of the merger, the combined company is expected to have outstanding a total of approximately 120.1 million shares of common stock (prior to giving effect to the proposed reverse stock split) immediately following the completion of the merger. Approximately 49.8 million of such shares of common stock will be freely tradable, without restriction, in the public market. Approximately 70.3 million of such shares will be held by directors, executive officers of the combined company and other affiliates and will be subject to volume limitations under Rule 144 under the Securities Act and various vesting agreements.

If the ownership of the combined company common stock is highly concentrated, it may prevent you and other stockholders from influencing significant corporate decisions and may result in conflicts of interest that could cause the combined company stock price to decline.

Executive officers and directors of the combined company and their affiliates are expected to beneficially own or control approximately 39.1% of the outstanding shares of the combined company common stock following the completion of the merger. Accordingly, these executive officers, directors and their affiliates, acting as a group, will have substantial influence over the outcome of corporate actions requiring stockholder approval, including the election of directors, any merger, consolidation or sale of all or substantially all of the combined company assets or any other significant corporate transactions. These stockholders may also delay or prevent a change of control of the combined company, even if such a change of control would benefit the other stockholders of the combined company. The significant concentration of stock ownership may adversely affect the trading price of the combined company’s common stock due to investors’ perception that conflicts of interest may exist or arise.

Because the merger will result in an ownership change under Section 382 of the Code for OncoGenex, pre-merger net operating loss carryforwards and certain other tax attributes will be subject to limitations.

If a corporation undergoes an “ownership change” within the meaning of Section 382 of the Code, the corporation’s net operating loss carryforwards and certain other tax attributes arising from before the ownership change are subject to limitations on use after the ownership change. In general, an ownership change occurs if there is a cumulative change in the corporation’s equity ownership by certain stockholders that exceeds fifty percentage points over a rolling three-year period. Similar rules may apply under state tax laws. The merger will result in an ownership change for OncoGenex and, accordingly, OncoGenex’s net operating loss carryforwards and certain other tax attributes will be subject to limitations on their use after the merger.

Anti-takeover provisions under Delaware law could make an acquisition of the combined company more difficult and may prevent attempts by the combined company stockholders to replace or remove the combined company management.

Because the combined company will be incorporated in Delaware, it is governed by the provisions of Section 203 of the Delaware General Corporate Law, which prohibits stockholders owning in excess of 15% of the outstanding combined company voting stock from merging or combining with the combined company. Although OncoGenex and Achieve believe these provisions collectively will provide for an opportunity to receive higher bids by requiring potential acquirors to negotiate with the combined company’s board of directors, they would apply even if the offer may be considered beneficial by some stockholders. In addition, these provisions may frustrate or prevent any attempts by the combined company’s stockholders to replace or remove then current management by making it more difficult for stockholders to replace members of the board of directors, which is responsible for appointing the members of management.

The bylaws of the combined company will provide that the Court of Chancery of the State of Delaware is the exclusive forum for substantially all disputes between the combined company and its stockholders, which could limit its stockholders’ ability to obtain a favorable judicial forum for disputes with the combined company or its directors, officers or other employees.

The bylaws of the combined company will provide that the Court of Chancery of the State of Delaware is the sole and exclusive forum for any derivative action or proceeding brought on the combined company’s behalf, any

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action asserting a breach of fiduciary duty owed by any of its directors, officers or other employees to the combined company or its stockholders, any action asserting a claim against it arising pursuant to any provisions of the Delaware General Corporation Law, its certificate of incorporation or its bylaws, or any action asserting a claim against it that is governed by the internal affairs doctrine. The choice of forum provision may limit a stockholder’s ability to bring a claim in a judicial forum that it finds favorable for disputes with the combined company or its directors, officers or other employees, which may discourage such lawsuits against the combined company and its directors, officers and other employees. If a court were to find the choice of forum provision contained in the bylaws to be inapplicable or unenforceable in an action, the combined company may incur additional costs associated with resolving such action in other jurisdictions.

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