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would be subject to delisting unless we do not regain compliance within the allotted compliance period(s), including any extensionstimely request a hearing before a Nasdaq Hearings Panel (the "Panel"). Additionally, on March 18, 2019, we received an additional letter from NASDAQ notifying us that may be granted by Nasdaq or failwe failed to comply with or other requirementsthe minimum $2.5 million stockholders' equity requirement for continued listing under Nasdaq Listing Rule 5550(b) (the "Stockholders' Equity Rule"). Nasdaq indicated that this matter served as an additional basis for delisting our common stock maysecurities from Nasdaq and that the Panel will consider this matter. We requested a hearing before the Panel, which was held on April 11, 2019. On May 3, 2019, the Panel notified us that they have accepted our compliance plan and granted us an extension until August 26, 2019 to regain compliance with the above noted criteria. While the Panel has accepted our compliance plan, there can be delisted andno assurance that we will be able to evidence compliance with such plan within the priceperiod of our common stock and our abilitytime that the Panel granted us to access the capital markets could be negatively impacted.do so.

        A delisting of our common stock from theThe Nasdaq Capital Market could materially reduce the liquidity of our common stock and result in a corresponding material reduction in the price of our common stock. In addition, delisting could harm our ability to raise capital through alternative financing sources on terms acceptable to us, or at all, and may result in the potential loss of confidence by investors, employees and fewer business development opportunities.

The warrants are speculative in nature.

The warrants do not confer any rights of common stock ownership on its holders, such as voting rights or the right to receive dividends, but rather merely represent the right to acquire shares of common stock at a fixed price (subject to adjustment therein) for a limited period of time. Specifically, for a period of five years commencing upon the date of issuance, holders of the warrants may exercise their right to acquire the common stock and pay an exercise price equal to $            (        % of the offering price per Class A Unit.Unit). Moreover, the market value of the warrants is uncertain and the warrants will not be listed or quoted for trading on any market or exchange. There can be no assurance that the market price of the common stock will ever equal or exceed the exercise price of the warrants, and consequently, whether it will ever be profitable for holders of the warrants to exercise the warrants.

A large number of shares issued in this offering may be sold in the market following this offering, which may depress the market price of our common stock.

A large number of shares issued in this offering may be sold in the market following this offering, which may depress the market price of our common stock. Sales of a substantial number of shares of our common stock in the public market following this offering could cause the market price of our common stock to decline. If there are more shares of common stock offered for sale than buyers are willing to purchase, then the market price of our common stock may decline to a market price at which buyers are willing to purchase the offered shares of common stock and sellers remain willing to sell the shares. All of the shares of common stock issued in the offering will be freely tradable without restriction or further registration under the Securities Act.

There is no public market for the warrants or the Series DE Preferred.

There is no established public trading market for the warrants or the Series DE Preferred offered in this offering, and we do not expect a market to develop. In addition, we do not intend to apply to list the warrants or the Series DE Preferred on any national securities exchange or other nationally recognized trading system, including the Nasdaq Capital Market. Without an active market, the liquidity of the warrants and the Series DE Preferred will be limited.

We have not paid dividends in the past and have no immediate plans to pay dividends.

We plan to reinvest all of our earnings, to the extent we have earnings, in order to further develop our productsproduct candidate and to cover operating costs. We do not plan to pay any cash dividends with respect to our securities in the foreseeable future. We cannot assure you that we would, at any time, generate sufficient surplus cash that would be available for distribution to the holders of our common stock as a dividend. Therefore, you should not expect to receive cash dividends on the common stock we are offering.

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CAUTIONARY STATEMENT REGARDING FORWARD-LOOKING STATEMENTS

This prospectus contains forward-looking statements, which reflect our current expectations and projections about future events and financial trends that we believe may affect our business, financial condition and results of operations. These forward-looking statements speak only as of the date of this prospectus and are subject to a number of risks, uncertainties and assumptions described under the sectionssection entitled “Risk Factors” and “Management’s Discussion and Analysis of Financial Condition and Results of Operations.”"Risk Factors."

These statements are not guarantees of future performance and involve risks and uncertainties that are difficult to predict or are beyond our control. A number of important factors could cause actual outcomes and results to differ materially from those expressed in these forward-looking statements. Consequently, readers should not place undue reliance on such forward-looking statements. In addition, these forward-looking statements relate to the date on which they are made.

The forward-looking statements reflect our current expectations and are based on information currently available to us and on assumptions we believe to be reasonable. Forward-looking information is subject to known and unknown risks, uncertainties and other factors that may cause our actual results, activities, performance or achievements to be materially different from that expressed or implied by such forward-looking statements. These forward-looking statements include, but are not limited to:

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·Market conditions;

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Our capital position;

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Our ability to compete with larger, better financed pharmaceutical companies;

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Our uncertainty of developing marketable products;

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Our ability to develop and commercialize our products;

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Our ability to obtain regulatory approvals;

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Our ability to maintain and protect intellectual property rights;

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The inability to raise additional future financing and lack of financial and other resources;

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Our ability to control product development costs;

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We may not be able to attract and retain key employees;

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We may not be able to compete effectively;

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We may not be able enter into new strategic collaborations;

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Changes in government regulation affecting product candidates could increase our development costs;

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Our involvement in patent and other intellectual property litigation could be expensive and could divert management’smanagement's attention;

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The possibility that there will be no market acceptance for our products; and

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Changes in third-party reimbursement policies could adversely affect potential future sales of any of our products that are approved for marketing.

Although we have attempted to identify important factors that could cause actual actions, events or results to differ materially from those described in forward-looking information, there may be other factors that cause actions, events or results to differ from those anticipated, estimated or intended. The forward-looking information contained herein is made as of the date of this prospectus and, other than

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as required by law, we do not assume any obligation to update any forward-looking information, whether as a result of new information, future events or results or otherwise.

You should also read the matters described in “Risk Factors”"Risk Factors" and the other cautionary statements made in this prospectus as being applicable to all related forward-looking statements wherever they appear in this prospectus. The forward-looking statements in this prospectus may not prove to be accurate and therefore you are encouraged not to place undue reliance on forward-looking statements. You should read this prospectus completely.

This prospectus also includes estimates and other statistical data made by independent parties and

by us relating to market size and growth and other data about our industry. This data involves a number of assumptions and limitations, and you are cautioned not to give undue weight to such estimates. In addition, projections, assumptions and estimates of our future performance and the future performance of the markets in which we operate are necessarily subject to a high degree of uncertainty and risk.

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USE OF PROCEEDS

We estimate that the net proceeds of this offering will be approximately $[        ] million, from the sale of our securities in this offering after deducting the placement agent fees and estimated offering expenses payable by us. The public offering price per unit waswill be negotiated between us and the placement agentsinvestors based on market conditions at the time of pricing, and representsmay represent a discount to the current market price of our common stock. This amount excludes the proceeds, if any, from the exercise of warrants in this offering. If all of the warrants sold in this offering were to be exercised in cash at an assumed exercise price of $[        ] per share, we would receive additional net proceeds of approximately $[        ] million. We cannot predict when or if these warrants will be exercised. It is possible that these warrants may expire and may never be exercised.

        We anticipate that approximately $1.25 million of the net proceeds from the offering will be used to repay a promissory note issued in March 2019. The promissory note bears no interest per annum and matures on June 30, 2019.

We intend to use the netremainder of the proceeds from this offering to fund our research and development activities and for general corporate purposes, including working capital. We may use the net proceeds from this offering to fund possible acquisitions of other companies, products or technologies, though no such acquisitions are currently contemplated.

This expected use of our net proceeds from this offering represents our intentions based upon our current plans and business conditions, which could change in the future as our plans and business conditions evolve. The amounts and timing of our actual expenditures may vary significantly depending on numerous factors, including the progress of our drug candidate development, the status of and results from clinical trials, as well as any collaborations that we may enter into with third parties for our drug candidates,candidate, and any unforeseen cash needs.

As a result, our management will retain broad discretion over the allocation of the net proceeds from this offering, and investors will be relying on the judgment of our management regarding the application of the net proceeds from this offering. The timing and amount of our actual expenditures will be based on many factors, including cash flows from operations and the anticipated growth of our business.

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·an actual basis; and

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a pro forma basis, to give effect to (i) the paymentredemption of $1,000,000principal and the issuance of 100,723 shares (approximately $55,000 valueinterest expense on the date of issuance) of our common stock to the Ciclofilin shareholders in October 2018 upon achievement of a milestone (as partial payment of contingent consideration for which the corresponding liability is not shown in the table below) and (ii) the $1,112,500 repayment of investor notes issued to IRT duringIliad on April 2, 2019 and April 3, 2019 such redemption consisting of issuances of 1,304,058 shares of common stock for a total value of $200,000, (ii) the period from November 1, 2018 through January 28,issuance of 17.8 million shares of common stock in the April 2019 Financing for total net proceeds of $1.9 million, net of placement agent fees and expenses, and (iii) the issuance of 1.4 million shares of common stock relating to the exercise of warrants in April 2019; and

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a pro forma, as adjusted basis giving further effect to the sale by us in this offering of [            ] Class A Units, at the assumed public offering price of $[            ] per Class A Unit andor up to [            ] Class B Units, at the public offering price of $1,000 per Class B Unit, assuming conversion of all Series DE Preferred Shares included in the Class B Units, after deducting placement agent fees and expenses and commissions and estimated offering expenses payable by us.

The pro forma information set forth inus and the table below is illustrative only and will be adjusted based onpayment of $             million of the actual public offering price and other termsnet proceeds of this offering determined at pricing.

to repay certain indebtedness, as described under "Use of Proceeds".

As of September 30, 2018

The above table is based on 16,315,14020,790,029 shares of common stock outstanding as of September 30, 2018March 31, 2019 and unless otherwise indicated, excludes:

·                       830,027

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630,936 shares of our common stock issuable upon exercise of outstanding options at a weighted average price of $11.89$10.63 per share;

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7,839,180 shares of our common stock issuable upon exercise of outstanding warrants with a weighted-average exercise price of 4.48$4.38 per share;

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                       100,723

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1,304,058 shares of our common stock issued to Iliad Research and Trading, L.P. ("Iliad") upon a redemption equalling $200,000 (including interest thereon) of the Ciclofilin shareholders as a milestone paymentoutstanding balance of the convertible promissory note issued by the Company to Iliad in October 2018;

May 2018 (the "Iliad Note") on April 2, 2019 and April 3, 2019;·



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222,867 shares of our common stock issuable upon conversion of outstanding shares of Series A Convertible Preferred Stock;

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                       1,453,550

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1,243,872 shares of our common stock issuable upon conversion of outstanding shares of Series C Convertible Preferred Stock;

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                       507,473

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706,564 shares of our common stock that are reserved for equity awards that may be granted under our equity incentive plans;

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17,833,334 shares of our common stock in the April 2019 Financing comprised of 13,491,666 shares of our common stock and 4,341,668 common stock equivalents subsequently issued upon conversion of 521 Series D Preferred Stock;



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18,546,667 warrants issued in the April 2019 financing of which 1,400,000 warrants were exercised into our common stock resulting in 17,146,667 shares of our common stock issuable upon conversionexercise of warrants issued in the Series D Preferred offered hereby;

April 2019 Financing, with an exercise price of $0.12 per share;·



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[            ] shares of our common stock issuable upon exercise of the warrants offered hereby; and

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[            ] shares of our common stock issuable upon exercise of the warrant to be issued to the placement agents in connection with this offering.

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DESCRIPTION OF SECURITIES WE ARE OFFERING

We are offering up to [            ] Class A Units consisting of one share of our common stock and one warrant to purchase            shares of our common stock, at an exercise price equal to $            (        % of the public offering price of the Class A Units per share of common stock,Units), which warrants will be exercisable upon issuance and will expire five (5) years from date of issuance. The sharesshare of common stock and warrantswarrant that are part of a Class A Unit are immediately separable and will be issued separately in this offering.

We are also offering to those purchasers, if any, whose purchase of Class A Units in this offering would otherwise result in the purchaser, together with its affiliates and certain related parties, beneficially owning more than 4.99% of our outstanding common stock immediately following the consummation of this offering, the opportunity, in lieu of purchasing Class A Units, to purchase Class B Units. Each Class B Unit will consist of one share of our newly designated Series DE Preferred with a stated value of $1,000 and convertible into shares of our common stock at the public offering price of the Class A Units, together with the equivalent number of warrants as would have been issued to such purchaser of Class B Units if they had purchased Class A Units. For each Class B Unit we sell, the number of Class A Units we are offering will be decreased on a one-for-one basis.by $1,000 divided by the Class A Unit public offering price. The shares of Series DE Preferred and warrants that are part of a Class B Unit are immediately separable and will be issued separately in this offering. We are also offering the shares of common stock issuable upon exercise of the warrants and conversion of the Series DE Preferred.

General

We are authorized to issue up to 120,000,000 shares of common stock, $0.0001 par value per share, and 20,000,000 shares of preferred stock, $0.0001 par value per share.

As of September 30, 2018,March 31, 2019, there were 16,315,14020,790,029 shares of our common stock issued and outstanding, 85,581 shares of Series A convertible preferred stock outstanding, and 2,2531,928 shares of Series C convertible preferred stock outstanding.

Common Stock

Holders of common stock are entitled to receive ratably dividends out of funds legally available, if and when declared from time to time by our Board. We have never paid any cash dividends on our common stock and our Board does not anticipate that we will pay cash dividends in the foreseeable future. The future payment of dividends, if any, on our common stock is within the discretion of the Board and will depend upon earnings, capital requirements, financial condition and other relevant factors. Holders of common stock are entitled to one vote for each share held on each matter to be voted on by stockholders. There is no cumulative voting in the election of directors. In the event of liquidation, dissolution or winding up of the affairs of us, holders of common stock are to share in all assets remaining after the payment of liabilities and any preferential distributions payable to preferred stockholders, if any. The holders of common stock have no preemptive or conversion rights and are not subject to further calls or assessments. There are no redemption or sinking fund provisions applicable to the common stock. The rights of the holders of the common stock are subject to any rights that may be fixed for holders of preferred stock, if any. All of the outstanding shares of common stock are fully paid and non-assessable.

Preferred Stock

The following is a summary of the material terms of our Series A Convertible Preferred Stock, Series C Convertible Preferred Stock, Series D Convertible Preferred Stock and the Series DE Preferred. This summary is not complete. The following summary is qualified in its entirety by reference to the Certificate of Designation of the Series A Convertible Preferred Stock, the Certificate of Designation of the Series C Convertible Preferred Stock, the Certificate of Designation of the Series C Convertible Preferred Stockand