If any of the securities being registered on this Form are to be offered on a delayed or continuous basis pursuant to Rule 415 under the Securities Act of 1933, check the following box.   ☐

If this Form is filed to register additional securities for an offering pursuant to Rule 462(b) under the Securities Act, please check the following box and list the Securities Act registration statement number of the earlier effective registration statement for the same offering.    ☐

If this Form is a post-effective amendment filed pursuant to Rule 462(c) under the Securities Act, check the following box and list the Securities Act registration statement number of the earlier effective registration statement for the same offering.    ☐

If this Form is a post-effective amendment filed pursuant to Rule 462(d) under the Securities Act, check the following box and list the Securities Act registration statement number of the earlier effective registration statement for the same offering.    ☐

Indicate by check mark whether the registrant is a large accelerated filer, an accelerated filer, a non-accelerated filer, or a smaller reporting company. See the definitions of “large accelerated filer,” “accelerated filer” and “smaller reporting company” in Rule 12b-2 of the Exchange Act.

The Registrant is an “emerging growth company,” as defined in Section 2(a) of the Securities Act. This registration statement complies with the requirements that apply to an issuer that is an emerging growth company.

The Registrant hereby amends this registration statement on such date or dates as may be necessary to delay its effective date until the Registrant shall file a further amendment which specifically states that this registration statement shall thereafter become effective in accordance with Section 8(a) of the Securities Act of 1933 or until the registration statement shall become effective on such date as the Commission, acting pursuant to such Section 8(a), may determine.

You should rely only on the information contained in this prospectus. Neither we nor the underwriter has authorized anyone to provide you with information different from, or in addition to, that contained in this prospectus or any free writing prospectus prepared by or on behalf of us or to which we may have referred you in connection with this offering. We take no responsibility for, and can provide no assurance as to the reliability of, any other information that others may give you. Neither we nor the underwriter is making an offer to sell or seeking offers to buy these securities in any jurisdiction where, or to any person to whom, the offer or sale is not permitted. The information in this prospectus is accurate only as of the date on the front cover of this prospectus, regardless of the time of delivery of this prospectus or of any sale of shares of our common stock, and the information in any free writing prospectus that we may provide to you in connection with this offering is accurate only as of the date of that free writing prospectus. Our business, financial condition, results of operations and future growth prospects may have changed since those dates.

Unless otherwise indicated, information contained in this prospectus concerning our industry and the markets in which we operate, including our general expectations and market position, market opportunity and market share, is based on information from our own management estimates and research, as well as from industry and general publications and research, surveys and studies conducted by third parties. Management estimates are derived from publicly available information, our knowledge of our industry and assumptions based on such information and knowledge, which we believe to be reasonable. Our management estimates have not been verified by any independent source, and we have not independently verified any third-party information. In addition, assumptions and estimates of our and our industry’s

future performance are necessarily subject to a high degree of uncertainty and risk due to a variety of factors, including those described in “Risk Factors.” These and other factors could cause our future performance to differ materially from our assumptions and estimates. See “Cautionary Note Regarding Forward-Looking Statements.”

This prospectus may include trademarks, trade names and service marks that are the property of their respective holders. Solely for convenience, trademarks and trade names referred to in this prospectus may appear without the​® and ™ symbols, but those references are not intended to indicate, in any way, that we will not assert, to the fullest extent under applicable law, our rights, or that the applicable holder will not assert its rights, to these trademarks and trade names. Use or display by us of other parties’ trademarks, trade dress or products in this prospectus is not intended to, and does not, imply a relationship with, or endorsements or sponsorship of, us by the trademark or trade dress owners.

This summary highlights selected information contained elsewhere in this prospectus. Because this is only a summary, it does not contain all of the information you should consider before investing in our common stock. You should read this prospectus carefully, especially the risks set forth under the heading “Risk Factors” and our financial statements and related notes included elsewhere in this prospectus, before making an investment decision. References in this prospectus, unless the context otherwise requires, to “Angion,” “our company,” “we,” “us” and “our” and other similar references refer to Angion Biomedica Corp.

We are a clinical stage biopharmaceutical company established in 1998 to focus on the discovery and clinical development of novel therapeutic agents to treat acute and chronic organ injury by harnessing the body’s protective, reparative and regenerative systems. The therapeutic strategy we follow and pathways we target were selected to prevent or limit acute injury, to prevent or limit acute injury from evolving into chronic disease and to stabilize, and potentially even reverse, chronic disease. We believe that these treatment objectives address significant unmet medical need. Our clinical programs are currently focused on renal transplantation, acute kidney disease and acute cardiac disease.

One of the body’s powerful regenerative systems is mediated by a growth factor called hepatocyte growth factor, or HGF, which is responsible for activating repair pathways under adverse conditions to prevent cell death and cellular dysfunction, thereby having the potential to limit long-term organ damage following injury or acute disease. We have discovered and developed a small molecule that mimics HGF’s endogenous biological roles of blocking apoptosis (or programmed cell death) and activating regenerative pathways, which can be administered during the post-injury period to achieve a therapeutic effect. Our most advanced drug candidate, BB3, has demonstrated significant benefit in several preclinical models of acute and chronic disease and injury, and is currently in Phase 2 clinical trials for the treatment of delayed graft function, or DGF, in renal transplant recipients.

Renal transplantation is our gateway indication for BB3 in order to reach the market as quickly as possible. We believe that BB3 has the potential to change the paradigm in renal transplantation by improving graft function, reducing the need for post-transplant dialysis, reducing hospitalization time and costs, and increasing the number of successful transplants for a population where demand for available organs greatly exceeds supply. In fact, many potentially useful organs are discarded because of suspected poor quality and unsuitability for transplant. We believe that BB3 has the potential to increase the number of transplantable organs that are otherwise discarded.

BB3 also has the potential to prevent or limit cardiac damage after myocardial infarction, or MI, also known as a heart attack, based on studies in several preclinical models. A significant number of survivors of a heart attack have a poor prognosis because the acute damage to the heart progresses into congestive heart failure, a chronic disease, despite early interventional procedures. By blocking apoptosis (programmed cell death) and activating repair pathways, BB3 has the potential to preserve heart tissue, and to limit expansion of the injury and its deterioration into heart failure. We initiated a Phase 2 trial of BB3 in patients having an angioplasty procedure immediately post-MI, but this trial was paused because the participation of a limited number of clinical sites resulted in inadequate patient recruitment. No safety issues were reported. This trial will be reactivated at additional sites in order to reach the recruitment target and to proceed with this indication following the present offering.

In preclinical models, BB3 has also been found to have the potential to prevent or limit acute kidney injury, or AKI, caused by toxins, including antibiotics, ischemia (i.e., the interruption or restriction of blood flow to tissues) and ischemia-reperfusion injury (i.e., tissue damage caused when blood supply returns to tissue after a period of lack of oxygen, which creates a condition in which the restoration of circulation results in inflammation and oxidative damage, rather than restoration of normal function). DGF in renal transplantation, as discussed above, is a special case of AKI that occurs in the donated, transported and then transplanted kidney. AKI occurs in approximately 7% of hospitalized patients, and significantly more often in critical care units, with high rates of progression to chronic kidney disease. Patients with

compromised renal function placed on cardiopulmonary bypass are particularly susceptible to AKI. We expect to start a Phase 2 trial in this population in the next six to nine months, with the objective of demonstrating a significant reduction in the incidence of AKI in post-cardiac surgery patients with pre-existing compromised renal function.

Our pipeline also includes ANG-3070, a kinase inhibitor with antifibrotic activities, for the treatment of chronic kidney disease and systemic sclerosis (an autoimmune connective tissue disease). This novel compound shows preclinical promise in blocking activation of cellular pathways involved in extracellular deposition of matrix (a material produced in excess by injured tissues that causes organ dysfunction and fibrosis) and scar formation.

In addition, we are conducting discovery studies to identify a therapeutically useful, proprietary compounds that target specific cytochrome P450s, or CYPs. CYPs are a large and diverse family of enzymes, some of which are responsible for the detoxification of drugs and ingested toxins, and others which are responsible for the metabolism of endogenous substances such as steroids, vitamins and lipids. We discovered a novel core chemical structure and have the technical expertise to develop derivatives with a goal of tailoring selectivity and developing individual compounds that inhibit a specific CYP and, potentially, modulate the levels of specific endogenous metabolites in order to treat certain acute and chronic diseases. Potential therapeutic applications of such compounds would be for the treatment of fibrosis and breast cancer (CYP26), solid tumors, including prostate cancer (CYP17), and chronic kidney disease, hypertension and heart failure (CYP11B2), as well as for improving the appearance of aged, maturing skin (CYP26).

Also in the discovery phase is our relaxin program. Relaxin is a naturally-occurring peptide that acts systemically on cells and tissues to inhibit fibrosis (the process of excessive collagen deposition following injury and in certain diseases) which is also responsible for major organ failure. We have discovered novel peptides that mimic relaxin’s biological activities in research model systems, and we are also developing a controlled release delivery system for relaxin in order to optimize its biological activities and avoids the need for repeated dosing and intravenous administration. In developing these programs, we are focusing on preventing or limiting cardiac damage after MI and treating chronic kidney disease.

We have had the benefit of receiving peer-reviewed, competitive grants and contracts from the National Institute of Health, or NIH, and the National Science Foundation, or NSF, under the Small Business Innovation Research, or SBIR, program. Since our inception in 1998, we have received more than $55.0 million in grant and contract funding. SBIR funding may continue to support programs from discovery through Phase 2 clinical development, and we intend to continue to compete for these funds in the future to support our programs, especially those programs in the discovery stage.

We are developing therapeutics for both orphan indications and large clinical markets of unmet medical need. In addition to our BB3 clinical programs, we have preclinical discovery and development programs that modulate or harness other cellular pathways to limit acute organ injury and chronic disease. These programs are projected to add new clinical candidates to our pipeline. We believe that our product candidates offer innovative therapeutic approaches and may provide significant advantages relative to current therapies. The following table summarizes our product candidates and programs:

We believe that there is a large unmet medical need and significant market opportunity for patient therapies that prevent or limit acute organ injury, prevent or limit acute organ injury from evolving into chronic disease, and stabilize, and even potentially reverse, chronic disease and organ damage. We believe that BB3, our other drug candidates, and compounds rising through our discovery programs will generate new medications that have the potential to transform the treatment of acute organ injury, and we strive to be the leader in improving the quality and quantity of life for large patient populations. Our principal corporate objective is the maximization of stockholder value by advancing BB3 through Phase 2 clinical development to Phase 3 in renal transplant within the next twelve months, with the goal of obtaining regulatory approval and, ultimately, commercialization. We also plan to continue and complete the multicenter Phase 2 trial of BB3 in MI, and to initiate clinical development of BB3 for AKI by either partnering or licensing out our intellectual property. These latter indications affect significantly larger populations than renal transplantation, for which we have an orphan drug designation from the FDA, and Fast Track designation for expedited regulatory review.

We are committed to applying our understanding of molecular modeling, medicinal chemistry and in vitro biology, as well as our expertise with multiple preclinical models of injury and disease to transform the lives of patients with acute and chronic debilitating and costly diseases and conditions. We also seek to support later-stage clinical development of our other clinical and preclinical candidates that we believe show significant potential to advance quickly to commercialization.

The key elements of our strategy are to:

We plan to continue in-house the clinical development of BB3 in renal transplantation to advance it into Phase 3 trials and through to regulatory approval. We are, however, considering whether we will license out any of our other programs to partners that have the expertise and resources to commercialize approved drugs or advance drug candidates rapidly into the clinic and onto the market. Currently, we have licensed to Ohr Cosmetics LLC the dermatological use of a CYP26 inhibitor from our platform CYP inhibitor program.

We are a clinical stage biopharmaceutical company, and our business and ability to execute our business strategy are subject to a number of risks of which you should be aware before you decide to invest in our common stock. In particular, you should consider the following risks, which are discussed more fully in the section entitled “Risk Factors”:

We were incorporated in the State of Delaware on April 6, 1998. Our principal executive offices are located at 51 Charles Lindbergh Boulevard, Uniondale, New York, 11553, and our telephone number is (516) 326-1200. Our website address is www.angion.com. The information contained on, or that can be accessed through, our website will not be deemed to be incorporated by reference into this prospectus and does not constitute part of this prospectus.

We qualify as an “emerging growth company” as defined in the Jumpstart Our Business Startups, or JOBS, Act of 2012. As an emerging growth company, we may take advantage of specified reduced disclosure and other requirements that are otherwise applicable generally to public companies. These provisions include:

We may take advantage of these exemptions for up to five years or such earlier time that we are no longer an emerging growth company. We would cease to be an emerging growth company on the date that is the earliest of (i) the last day of the fiscal year in which we have total annual gross revenues of $1.0 billion or more; (ii) the last day of our fiscal year following the fifth anniversary of the date of the completion of this offering; (iii) the date on which we have issued more than $1.0 billion in nonconvertible debt during the previous three years; or (iv) the date on which we are deemed to be a large accelerated filer under the rules of the Securities and Exchange Commission. We may choose to take advantage of some but not all of these exemptions. We have taken advantage of reduced reporting requirements in this prospectus. Accordingly, the information contained herein may be different than the information you receive from other public companies in which you hold stock.

The number of shares of common stock to be outstanding after this offering is based on an aggregate of 61,200 shares of common stock outstanding as of December 31, 2013, and excludes:

Unless otherwise indicated, this prospectus reflects and assumes the following:

The following tables set forth, for the periods and as of the dates indicated, our summary financial data. Our consolidated financial statements include the results of operations and financial position of NovaPark LLC, or NovaPark, a real estate entity, in which we own 10% of the membership interests, which we are required to consolidate into our financial statements under generally accepted accounting principles in the United States, or GAAP. NovaPark is excluded from this offering. The statement of operations data for the years ended December 31, 2013 and 2012, are derived from our audited consolidated financial statements included elsewhere in this prospectus. You should read this summary data together with the more detailed information contained in “Risk Factors,” “Selected Financial Data,” and “Management’s Discussion and Analysis of Financial Condition and Results of Operations” and our financial statements and related notes, all included elsewhere in this prospectus. Our historical results are not indicative of the results to be expected in the future and results of interim periods are not necessarily indicative of results for the entire year.

Investing in our common stock involves a high degree of risk. You should carefully consider the following risk factors, as well as the other information in this prospectus, including our financial statements and related notes, before deciding whether to invest in shares of our common stock. The occurrence of any of the adverse developments described in the following risk factors could materially and adversely harm our business, financial condition, results of operations or prospects. In that case, the trading price of our common stock could decline, and you may lose all or part of your investment.

We have not yet submitted any product candidates for approval by regulatory authorities in the United States or elsewhere for our lead indication, BB3, delayed graft function, or DGF, following renal transplant, or any other indication. Support for our clinical and other programs has come mainly from United States government grants. We currently have 9 funded United States government grants with remaining direct, indirect and fixed fees due to us of approximately $4.8 million as of December 31, 2013, which includes amounts payable to subcontractors who collaborate with us on our grants, such as university laboratories and clinical testing facilities. In addition, we have several NIH and Department of Defense, or DOD, grant applications pending which, if all are awarded and funded in accordance with the proposed budget, will provide an additional $3.0 to 4.0 million to us. Our working capital as of December 31, 2013, and December 31, 2012, were $1,471,616 and $959,801, respectively. Our cash and cash equivalents as of December 31, 2013 and December 31, 2012 were $2,057,250 and $1,404,493, respectively.

To date, we have devoted most of our financial resources to research and development and our corporate overhead, the former including our drug discovery research, preclinical development activities and clinical trials. We have not generated any revenues from product sales. We have received over $55.0 million in grants from the United States government that support our discovery, preclinical and clinical programs, provide overhead and provide us with a 7% fixed fee (i.e., a profit) on total direct and indirect costs, excluding subcontractor costs. As our clinical trials and preclinical development programs expand, we expect to incur losses for the foreseeable future. We expect these losses to increase as we continue our development of, and seek regulatory approvals for, BB3, our lead product candidate, and our other product candidates, prepare for and begin the commercialization of any approved products and add infrastructure and personnel to support our product development efforts and operations as a public company. We anticipate that any such losses could be significant for the next several years as we complete our Phase 2 clinical trial of BB3 in DGF and start Phase 3 trials necessary for regulatory approval, continue our Phase 2 study in MI, begin a Phase 2 study in AKI, complete preclinical development of our kinase inhibitor, ANG-3070 and our CYP26 inhibitor, ANG-3281. We also intend to advance our compounds that are currently in discovery into preclinical development and initiate Phase 1 trials on the most promising candidates. If BB3 or any of our other product candidates fail in clinical trials or do not gain regulatory approval, or if our product candidates do not achieve market acceptance, we may never become profitable. As a result of the foregoing, we expect to experience net losses and negative cash flows for the foreseeable future. These net losses and negative cash flows will have an adverse effect on our stockholders’ equity and working capital.

Topical formulations of our CYP26 inhibitor compound ANG-3522, for uses such as improving the appearance of skin resulting from conditions such as sun damage and aging are licensed to Ohr Cosmetics LLC, or Ohr Cosmetics, an affiliated company. We believe that this topical formulation will be regulated by the FDA as a cosmetic. If this product is successful, we anticipate royalty revenues, and milestone payments based on achievement of incremental gross revenues, in the future. Ohr Cosmetics has marketing rights under the patents in all countries in which a valid patent claim exists; a U.S. patent has been issued and applications are pending in Australia, Canada, China, Europe, India, Israel and Japan. We are dependent upon Ohr Cosmetics’ success in completing studies, marketing the product(s) and collecting revenues thereon in order for us to receive any revenues from milestones or royalty payments from this relationship.

Because of the numerous risks and uncertainties associated with pharmaceutical product development, we are unable to accurately predict the timing or amount of increased expenses or when, or if, we will be able to achieve profitability. In addition, our expenses could increase if we are required by the United States Food and Drug Administration, or FDA, or the European Medicines Agency, or EMA, to perform studies or trials in addition to those currently expected, or if there are any delays in completing our clinical trials or the development of any of our product candidates. The amount of future net losses will depend, in part, on the rate of future growth of our expenses and our ability to generate revenues. We also intend to partner or out-license our indications or compounds that address larger patient populations, but our ability to identify, negotiate, and complete such partnerships or licenses, and the ability of our partners or licensees to then meet their obligations and achieve market success and provide a revenue stream to us, is uncertain.

We are currently in the process of advancing BB3 through clinical development for multiple indications, and other product candidates through preclinical development. Developing pharmaceutical products, including conducting preclinical studies and clinical trials, is expensive. We will require substantial additional future capital in order to complete clinical development and commercialize BB3 and to conduct the research and development and clinical and regulatory activities necessary to bring our other product candidates to market. For instance, to complete the work necessary to submit a New Drug Application, or NDA, in the United States and a Marketing Authorization Application, or MAA, in the European Union for BB3 as a treatment for DGF, we estimate that our planned Phase 3 trial, and our planned clinical and preclinical studies, as well as other work needed to submit BB3 for the treatment of DGF for regulatory approval in the United States will cost approximately $8.0-9.0 million, including the internal resources needed to manage the program. At this stage, we are considering partnering with outside organizations to seek approval in Europe and other countries. If the FDA or EMA requires that we perform additional preclinical studies or clinical trials, our expenses would further increase beyond what we currently expect, and the anticipated timing of any potential NDA or MAA would likely be delayed.

We intend to use substantially all of the net proceeds from this offering to fund (i) the continued clinical development of BB3 in renal transplantation, advancement into Phase 3 trials and completing other work necessary for related FDA and EMA filings; (ii) conducting Phase 2 trials on BB3 for AKI; (iii) continuing BB3 Phase 2 trials in MI; (iv) completion of preclinical development of ANG-3070 and IND submission to the FDA; (v) completion of preclinical development of ANG-3281 and IND submission to the FDA; and (vi) continuing discovery work on our CYP inhibitor platform, our relaxin mimetic peptides, our relaxin delivery system and other discovery programs. Any remaining amounts will be used for general corporate purposes, general and administrative expenses, capital expenditures, working capital and prosecution and maintenance of our intellectual property. As such, the expected net proceeds from this offering will not be sufficient to complete advanced clinical development of any of our product candidates other than BB3 for DGF. Accordingly, we will continue to require substantial additional capital beyond the expected proceeds of this offering to continue our clinical development and commercialization activities. Because successful development of our product candidates is uncertain, we are unable to estimate the actual funds we will require to complete research and development and commercialize our products under development.

The amount and timing of our future funding requirements will depend on many factors, including, but not limited to:

Some of these factors are outside of our control. If we successfully complete this offering, based upon our currently expected level of operating expenditures, we believe that we will be able to fund our operations at least until the first quarter of 2016. This period could be shortened if there are any significant increases in planned spending on development programs or more rapid progress of development programs than anticipated. Other revenue may be realized from any advance payment from a licensing relationship for one or more of our programs, such as the dermatological use of our CYP26 inhibitor ANG-3522 for improving the appearance of aged skin being developed by Ohr Cosmetics LLC, as a cosmetic. However, the product’s regulatory status or FDA enforcement policy for cosmetic products like this one could change, subjecting this skin product to more regulatory scrutiny, which could require additional studies or delay or end the commercialization of this product.

We do not expect our existing capital resources, including the intended net proceeds from this offering, to be sufficient to enable us to complete the advanced development of any program except that of BB3 for DGF. See also “Use of Proceeds.” Accordingly, we expect that we will need to raise additional funds in the future.

We may seek additional funding through a combination of equity offerings, debt financings, government or other third-party funding, marketing and distribution arrangements and other collaborations, strategic alliances and licensing arrangements. Additional funding may not be available to us on acceptable terms or at all. In addition, the terms of any financing may adversely affect the holdings or the rights of our stockholders. In addition, the issuance of additional shares by us, or the possibility of such issuance, may cause the market price of our shares to decline.

If we are unable to obtain funding on a timely basis, we may be required to significantly curtail one or more of our research or development programs. We also could be required to seek funds through arrangements with collaborative partners or otherwise that may require us to relinquish rights to some of our technologies or product candidates or otherwise agree to terms unfavorable to us.

To date, our sources of revenue have been almost exclusively United States government grants, principally from the National Institutes of Health, or NIH, and National Science Foundation, or NSF. These funds have allowed us to progress our most advanced candidates into clinical development and preclinical development. These grants also provide fringe benefits and indirect costs used to support our overhead expenses, as well as a fixed fee (i.e., profit) equal to 7% of total direct and indirect costs of the grant award, excluding subcontractor costs. We currently have 9 funded grants with remaining direct, indirect and fixed fees due to us of approximately $4.8 million as of December 31, 2013, which includes amounts due to our grant subcontractors who collaborate with us on our grants, such as university laboratories and clinical testing facilities. In addition, we have several NIH and DOD grant applications pending which, if all are awarded and funded in accordance with the proposed budget, would provide an additional $3.0 to $4.0 million to us. We compete for funding under the Small Business Innovation Research, or SBIR, program. This program sets aside a certain percent of federal funds exclusively for small businesses. In the future, we will continue to seek grant funds for our earlier stage programs to continue discovery activities and advance promising discovery compounds into preclinical development. If future grants cannot be obtained, we may not be able to use the SBIR mechanism or other non-dilutive sources of funding to support our preclinical development pipeline of discovery candidates, or start any new programs to identify targets in other disease pathways and develop new therapeutic modalities.

If we are unable to develop and commercialize one or more of our product candidates, either alone or with collaborators, or if revenues from any such collaboration product candidate that receives marketing approval are insufficient, we will not achieve profitability. Even if we achieve profitability, we may not be able to sustain or increase profitability.

To be defined as a small business for SBIR purposes, a company must be more than 50 percent directly owned and controlled by one or more individuals (who are citizens or permanent resident aliens of the United States), other small business concerns (each of which, in turn, is more than 50% directly owned and controlled by individuals who are citizens or permanent resident aliens of the United States), or any combination thereof. For certain granting agencies, including NIH, a small business is not eligible if it is majority-owned by multiple venture capital operating companies, hedge funds or private equity firms. We expect to maintain, after this offering, our current ownership structure where more than 50% of our outstanding shares are privately held, thus maintaining eligibility for SBIR funding. However, whether we can maintain our ownership structure in order to qualify for SBIR grant funding after future financings or investments cannot be assured, in which case we would become ineligible for SBIR grants.

An important element of a biotechnology company’s strategy for developing, manufacturing and commercializing its drug candidates may be to enter into strategic alliances with pharmaceutical companies or other industry participants to advance its programs and enable it to maintain its financial and operational capacity. We may face significant competition in seeking appropriate alliances. If we seek such alliances, we may not be able to negotiate alliances on acceptable terms, if at all. In addition, these alliances may be unsuccessful. If we seek such alliances and then fail to create and maintain suitable alliances, we may have to limit the size or scope of, or delay, one or more of our drug development or research programs. If we elect to fund drug development or research programs on our own, we will have to increase our expenditures and will need to obtain additional funding, which may be unavailable or available only on unfavorable terms.

We are currently party to a license agreement with Ohr Cosmetics LLC. Biotechnology companies at our stage of development sometimes become dependent upon collaborative arrangements or strategic

alliances to complete the development and commercialization of drug candidates, particularly after the Phase 2 stage of clinical testing. If we elect to enter into additional collaborative arrangements or strategic alliances, these arrangements may place the development of our drug candidates outside our control, may require us to relinquish important rights or may otherwise be on terms unfavorable to us.

Dependence on collaborative arrangements or strategic alliances would subject us to a number of risks, including the risk that:

We are a clinical stage biopharmaceutical company in operation since 1998. Our operations to date have been limited to developing our technology and undertaking preclinical studies and clinical trials of our product candidates. We have not yet obtained regulatory approvals for marketing any of our product candidates. Consequently, any predictions made about our future success or viability may not be as accurate as they could be if we had a longer operating history or approved products on the market. Our financial condition and operating results have varied significantly in the past and are expected to continue to significantly fluctuate from quarter-to-quarter or year-to-year due to a variety of factors, many of which are beyond our control. Factors relating to our business that may contribute to these fluctuations include:

To date, we have mainly relied upon United States government grants to fund our operations and have operated at a profit because of a contractual profit margin contained in such grants, as well as revenues from tax credit programs. The planned expansion of our clinical and discovery programs will require significant additional funds beyond those projected to be obtainable by currently funded and future grants, and we will rely on the proceeds from this offering to expand these programs. If, in the future, our independent registered public accounting firm were to include an explanatory paragraph in its report on our financial statements stating there is substantial doubt about our ability to continue as a going concern, such an opinion could materially limit our ability to raise additional funds through the issuance of new debt or equity securities or otherwise. There is no assurance that sufficient financing will be available when needed to allow us to continue as a going concern. The perception that we may not be able to continue as a going concern may cause others to choose not to deal with us due to concerns about our ability to meet our contractual obligations.

We are required to consolidate NovaPark into our financial statements under GAAP, and we own 10% of the membership interests of NovaPark. We also guarantee NovaPark’s obligations under the mortgage on the building that NovaPark owns. As a result, we are subject to the following risks:

We will be developing BB3 for the treatment of patients with DGF, AKI, and MI. We are developing ANG-3070 for the treatment of chronic kidney disease, and dermatological uses of our CYP26 inhibitor ANG-3522 under development by our licensee, Ohr Cosmetics LLC. We also have several discovery programs advancing other compounds into preclinical development. Our business currently depends on the successful development and commercialization of BB3 for several indications, and advancing other compounds through our pipeline. Our ability to generate revenue related to product sales, if ever, will depend on the successful development and regulatory approval of BB3 for the treatment of DGF and other indications, ANG-3070 for chronic kidney disease and our other discovery program candidates.

We currently have no products approved for sale, and we cannot guarantee that we will ever have marketable products. The development of a product candidate and issues relating to its approval and marketing are subject to extensive regulation by the FDA in the United States, the EMA in the European Union and other regulatory authorities in other countries, with regulations differing from country to country. We are not permitted to market our drug product candidates in the United States or Europe until we receive approval of an NDA from the FDA or an MAA from the EMA. We have not submitted any marketing applications for any of our product candidates.

The topical formulation of CYP26 inhibitor ANG-3522 for treatment of adverse skin conditions is under development by our licensee, Ohr Cosmetics LLC. We believe that that product will be regulated as a cosmetic and will not require approval from the FDA or EMA, provided the product’s labeling and advertising does not make any claims that the FDA deems drug-like. The regulatory status or FDA enforcement policy for cosmetic products like this one could change, however, subjecting the cosmetic product to more regulatory scrutiny, which could require additional studies or delay or end the commercialization of this product.

NDAs and MAAs must include extensive preclinical and clinical data and supporting information to establish the product candidate’s safety and effectiveness for each desired indication. NDAs and MAAs must also include significant information regarding the chemistry, manufacturing and controls for the product. Obtaining approval of an NDA or an MAA is a lengthy, expensive and uncertain process, and we may not be successful in obtaining approval. The FDA and the EMA review processes can take years to complete, and approval is never guaranteed. If we submit an NDA to the FDA, the FDA must decide whether to accept or reject the submission for filing. We cannot be certain that any submission will be accepted for filing and review by the FDA. Regulators in other jurisdictions, such as the EMA, have their own procedures for approval of product candidates. Even if a product is approved, the FDA or the EMA, as the case may be, may limit the indications for which the product may be marketed, require extensive warnings on the product labeling or require expensive and time-consuming additional clinical trials or reporting as conditions of approval. Regulatory authorities in countries outside of the United States and European Union also have requirements for approval of drug candidates with which we must comply prior to marketing in those countries. Obtaining regulatory approval for marketing of a product candidate in one country does not ensure that we will be able to obtain regulatory approval in any other country. In addition, delays in approvals or rejections of marketing applications in the United States, Europe or other countries may be based upon many factors, including regulatory requests for additional analyses, reports, data, preclinical studies and clinical trials, regulatory questions regarding different interpretations of data and results, changes in regulatory policy during the period of product development and the emergence of new information regarding our product candidates or other products. Also, regulatory approval for any of our product candidates if granted may be withdrawn.

We are conducting two Phase 2 clinical trials on BB3 in DGF. We are awaiting the completion and unblinding of these trials in order to evaluate the extent of efficacy and to design the protocol for our planned pivotal Phase 3 trials to be discussed with the FDA at an end-of-Phase 2 meeting. Before we submit an NDA to the FDA or an MAA to the EMA for BB3 for the treatment of patients with DGF, we must successfully complete this planned Phase 3 trial. We cannot predict whether our future trials and studies will be successful, or whether regulators will agree with our conclusions regarding the preclinical studies and clinical trials we have conducted to date. For our preclinical development programs, we will need to conduct Phase 1, Phase 2 and Phase 3 clinical trials.

We initiated a Phase 2 trial of intravenously, or IV, administered BB3 in patients undergoing an MI, but the trial was paused because the primary clinical site did not reach the recruitment target set by the NIH. We intend to restart this clinical trial in the future at additional sites in order to reach the recruitment target and to proceed with this indication.

We conducted Phase 1 trials using IV-administered BB3 in dialysis patients and in liver fibrosis patients, which provided additional pharmacokinetics, or PK, and safety data for our clinical trials and proceeding into AKI patients in the near future. We plan to study BB3 in AKI patients with a portion of the proceeds from this offering.

If we are unable to obtain approval from the FDA, the EMA or other regulatory agencies for BB3 and our other product candidates or, if, subsequent to approval, we are unable to successfully commercialize BB3 or our other product candidates, we will not be able to generate sufficient revenue to become profitable or to continue our operations.

We planned our DGF clinical trials based on discussions with the FDA. We have an FDA orphan drug designation for BB3 (under the name Refanalin) for the DGF indication, and Fast Track status. The clinically relevant endpoints are related to renal function, the need for or the number of dialysis sessions the patient requires, as well as length of hospitalization and graft survival. We may, however, never reach an agreement with the FDA on the statistical significance of the efficacy endpoints’ data, if any, for the accelerated approval of BB3 for the treatment of DGF. The FDA, EMA and other regulators may require us to complete additional Phase 3 trials prior to the submission of an application for BB3 for the treatment of DGF.

Delays in the commencement, enrollment and completion of clinical trials could increase our product development costs or limit the regulatory approval of our product candidates. We are currently enrolling patients for our two Phase 2 trials on BB3 in DGF. We currently expect results from these trials to be available by the fourth quarter of 2014. Although we anticipate that the net proceeds from this offering will be sufficient to fund our projected operating requirements through the completion of Phase 2 and subsequent Phase 3 trials, we may not be able to complete these trials on time or we may be required to conduct additional clinical trials or preclinical studies not currently planned to receive approval for BB3 as a treatment for DGF, in which case we would require additional funding beyond the net proceeds of this offering. We are also planning to continue our Phase 2 study on BB3 in patients with MI, and initiate a Phase 2 trial on BB3 in patients with AKI. In addition, we do not know whether any future trials or studies of our other product candidates will begin on time or will be completed on schedule, if at all. The commencement, enrollment and completion of clinical trials can be delayed or suspended for a variety of reasons, including:

Changes in regulatory requirements and related guidance may also occur and we or any of our collaborators may need to amend clinical trial protocols to reflect these changes. Amendments may require us or any of our collaborators to resubmit clinical trial protocols to IRBs for re-examination, which may impact the costs, timing or successful completion of a clinical trial. In addition, a clinical trial may be suspended or terminated at any time by us, our current or future collaborators, the FDA or other regulatory authorities due to a number of factors, including:

In addition, if we or any of our collaborators are required to conduct additional clinical trials or other preclinical studies of our product candidates beyond those contemplated, our ability to obtain regulatory approval of these product candidates and generate revenue from their sales would be similarly harmed.

Clinical failure can occur at any stage of our clinical development. Clinical trials may produce negative or inconclusive results, and we or our collaborators may decide, or regulators may require us, to conduct additional clinical trials or preclinical studies. In addition, data obtained from trials and studies are susceptible to various interpretations, and regulators may not interpret our data as favorably as we do, which may delay, limit or prevent regulatory approval. Success in preclinical studies and early clinical trials does not ensure that subsequent clinical trials will generate the same or similar results or otherwise provide adequate data to demonstrate the efficacy and safety of a product candidate. A number of companies in the pharmaceutical industry, including those with greater resources and experience than us, have suffered significant setbacks in Phase 3 clinical trials, even after seeing promising results in earlier clinical trials.

Our Phase 2 clinical trials of BB3 in renal transplant patients are ongoing. We cannot assure you that these trials will achieve positive results that will allow us to advance to a Phase 3 trial. Also, if our Phase 2 trials show positive results, we cannot predict that a Phase 3 trial will also show positive results.

In addition, the design of a clinical trial can determine whether its results will support approval of a product and flaws in the design of a clinical trial may not become apparent until the clinical trial is well-advanced. We have limited experience in designing clinical trials and may be unable to design and execute a clinical trial to support regulatory approval. Further, clinical trials of potential products often reveal that it is not practical or feasible to continue development efforts.

If BB3 or our other product candidates are found to be unsafe or lack efficacy, we will not be able to obtain regulatory approval for them and our business would be harmed. For example, if the results of Phase 3 trials of BB3 do not achieve the primary efficacy endpoints or demonstrate expected safety, the prospects for approval of BB3 would be materially and adversely affected.

In some instances, there can be significant variability in safety and/or efficacy results between different trials of the same product candidate due to numerous factors, including changes in trial protocols, differences in composition of the patient populations, adherence to the dosing regimen and other trial protocols and the rate of dropout among clinical trial participants. We do not know whether any Phase 2, Phase 3 or other clinical trials we or any of our collaborators may conduct will demonstrate consistent or adequate efficacy and safety to obtain regulatory approval to market our product candidates. If we are unable to bring any of our current or future product candidates to market, or to acquire any marketed, previously approved products, our ability to create long-term stockholder value will be limited.

Even if we successfully complete the clinical trials for one or more of our product candidates, the product candidates may fail for other reasons, including the possibility that the product candidates will:

If we are unable to receive the required regulatory approvals, secure our intellectual property rights, minimize the incidence of any adverse side effects or fail to compete with our competitors’ products, our business, financial condition, and results of operations could be materially and adversely affected.

Our research has been funded principally by United States government grants. Conducting research under federal grants required us to grant the United States government a nonexclusive, nontransferable, irrevocable, paid-up license for the government to practice or have the invention practiced on its behalf throughout the world. Under certain circumstances, the government can require the grantee to license a third party, or the government may take title and grant a license itself (“march-in rights”), which might occur if the invention was not brought to practical use within a reasonable time, if health or safety issues arise, if public use of the invention was in jeopardy or if other legal requirements were not satisfied. Although, to our knowledge, the United States government has never had occasion to force a grantee to license or has it taken title and granted a license itself, these march-in rights are available to the government, and we cannot assure you that the government may not exercise such rights in the future.

BB3 was designed to mimic the biological activities of hepatocyte growth factor, or HGF, which is responsible for activating repair pathways under adverse conditions to prevent cell death and cellular dysfunction. There are no approved compounds on the market that mimic the activities of HGF. Our

clinical trials in DGF, and anticipated dosing regimen (upon approval), is three or four daily intravenous doses following kidney transplant. Our planned restart of the Phase 2 trial in MI patients includes four daily doses. Our anticipated dosing regimen for the planned clinical trials in AKI is also short term. Although our BB3 dosing regimen is based on short-term exposure, the long-term effects from exposure to this drug class are unknown. Unforeseen side effects from any of our product candidates could arise either during clinical development or, if approved, after the approved product has been marketed. The most common side effect observed to date in clinical trials of BB3 was a transient metallic taste at a high dose which is not used in our Phase 2 trials. No drug-related serious adverse effects were observed. However, additional or unforeseen side effects from these or any of our other product candidates could arise either during clinical development or, if approved, while the approved product is being marketed.

The range and potential severity of possible side effects from systemic therapies is significant. The results of future clinical trials may show that our product candidates cause undesirable or unacceptable side effects, which could interrupt, delay or halt clinical trials, and result in delay of, or failure to obtain, marketing approval from the FDA and other regulatory authorities, or result in marketing approval from the FDA and other regulatory authorities with restrictive label warnings.

If any of our product candidates receives marketing approval and we or others later identify undesirable or unacceptable side effects caused by such products:

Any of these events could prevent us or any potential future collaborators from achieving or maintaining market acceptance of the affected product or could substantially increase commercialization costs and expenses, which, in turn, could delay or prevent us from generating significant revenues from the sale of our products.

Market acceptance and sales of BB3 or any other product candidates that we develop, if approved, will depend on reimbursement policies, and may be affected by future healthcare reform measures. Government authorities and third-party payors, such as private health insurers and health maintenance organizations, decide which drugs they will cover and establish payment levels. We cannot be certain that reimbursement will be available for BB3 or any other product candidates that we develop. Also, we cannot be certain that reimbursement policies will not reduce the demand for, or the price paid for, our products. If reimbursement is not available or is available on a limited basis, we may not be able to successfully commercialize BB3 or any other product candidates that we develop.

Our business may be affected by the efforts of government and third-party payors to contain or reduce the cost of healthcare through various means. For example, the Patient Protection and Affordable Care Act and the Health Care and Education Affordability Reconciliation Act of 2010, referred to jointly as the ACA, enacted in March 2010, substantially changed the way healthcare is financed by both governmental and private insurers, and significantly impacted the pharmaceutical industry. With regard to pharmaceutical products, among other things, ACA is expected to expand and increase industry rebates for drugs covered under Medicaid programs and make changes to the coverage requirements under the Medicare D program. Although most of the ACA has withstood court challenges, there are ongoing Congressional efforts to

repeal the ACA. This adds to the uncertainty of the legislative changes enacted as part of the ACA, and we cannot predict the impact that the ACA or any other legislative or regulatory proposals will have on our business. Regardless of whether or not the ACA is overturned or repealed, we expect both government and private health plans to continue to require healthcare providers, including healthcare providers that may one day purchase our products, to contain costs and demonstrate the value of the therapies they provide.

The United States and several other jurisdictions are considering, or have already enacted, a number of legislative and regulatory proposals to change the healthcare system in ways that could affect our ability to sell our products profitably. Among policy makers and payors in the United States and elsewhere, there is significant interest in promoting changes in healthcare systems with the stated goals of containing healthcare costs, improving quality and/or expanding access to healthcare. In the United States, the pharmaceutical industry has been a particular focus of these efforts and has been significantly affected by major legislative initiatives. We expect to experience pricing pressures in connection with the sale of products that we develop, due to the trend toward cost containment and additional legislative proposals.

Even if our product candidates are approved for commercial sale by the FDA or other regulatory authorities, the degree of market acceptance of any approved product candidate by physicians, health care professionals and third-party payors, and our profitability and growth will depend on a number of factors, including:

If any product candidate that we develop does not provide a treatment regimen that is at least as beneficial as the current standard of care or otherwise does not provide some additional patient benefit over the current standard of care, that product will not achieve market acceptance and we will not generate sufficient revenues to achieve profitability.

Depending upon the timing, duration and specifics of FDA marketing approval of BB3 and our other product candidates, if any, one or more of our United States patents may be eligible for limited patent term restoration under the Drug Price Competition and Patent Term Restoration Act of 1984, referred to as the Hatch-Waxman Act. The Hatch-Waxman Act permits a patent restoration term of up to five years as compensation for patent term lost during product development and the FDA regulatory review process. However, we may not be granted an extension because, for example, of failing to apply within applicable deadlines, failing to apply prior to expiration of relevant patents or otherwise failing to satisfy applicable requirements. Moreover, the applicable time period or the scope of patent protection afforded could be less than we request. If we are unable to obtain patent term extension or restoration or the term of any such extension is less than what we request, the period during which we will have the right to exclusively market our product will be shortened and our competitors may obtain approval of competing products following our patent expiration, and our revenue could be reduced, possibly materially. In the event that we are unable to obtain any patent term extensions, the issued pharmaceutical composition patent for BB3 is expected to expire during 2024, assuming it withstands any challenge. We expect that the other patents and patent applications in our BB3 portfolio, if issued, and if the appropriate maintenance, renewal, annuity or other governmental fees are paid, would expire from 2023 to 2029.

In addition to FDA restrictions on marketing of pharmaceutical products, several other types of state and federal healthcare laws, commonly referred to as “fraud and abuse” laws, have been applied in recent years to restrict certain marketing practices in the pharmaceutical industry. Other jurisdictions, such as Europe, have similar laws. These laws include false claims and anti-kickback statutes. If we market our products and our products are paid for by governmental programs, it is possible that some of our business activities could be subject to challenge under one or more of these laws.

Federal false claims laws prohibit any person from knowingly presenting, or causing to be presented, a false claim for payment to the federal government or knowingly making, or causing to be made, a false statement to get a false claim paid. The federal healthcare program anti-kickback statute prohibits, among other things, knowingly and willfully offering, paying, soliciting or receiving remuneration to induce, or in return for, purchasing, leasing, ordering or arranging for the purchase, lease or order of any healthcare item or service covered by Medicare, Medicaid or other federally financed healthcare programs. This statute has been interpreted to apply to arrangements between pharmaceutical manufacturers, on the one hand, and prescribers, purchasers or formulary managers, on the other. Although there are several statutory exemptions and regulatory safe harbors protecting certain common activities from prosecution, the exemptions and safe harbors are drawn narrowly, and practices that involve remuneration intended to induce prescribing, purchasing or recommending may be subject to scrutiny if they do not qualify for an exemption or safe harbor. Most states also have statutes or regulations similar to the federal anti-kickback law and federal false claims laws, which apply to items and services covered by Medicaid and other state programs, or, in several states, apply regardless of the payor. Administrative, civil and criminal sanctions may be imposed under these federal and state laws.

Over the past few years, a number of pharmaceutical and other healthcare companies have been prosecuted under these laws for a variety of promotional and marketing activities, such as: providing free trips, free goods, sham consulting fees and grants and other monetary benefits to prescribers; reporting inflated average wholesale prices that were then used by federal programs to set reimbursement rates; engaging in off-label promotion; and submitting inflated best price information to the Medicaid Rebate Program to reduce liability for Medicaid rebates.

We do not intend to manufacture the pharmaceutical products that we plan to sell. We currently have agreements with third-party contract manufacturers for the production of the active pharmaceutical ingredients and the formulation of sufficient quantities of drug product for our Phase 2 trials of BB3 for the treatment of DGF. However, we do not have agreements for commercial supplies of BB3 or any of our other product candidates, and we may not be able to reach agreements with these or other contract manufacturers for sufficient supplies to commercialize BB3 if and when it is approved. Additionally, the facilities at which BB3 or any of our other product candidates are manufactured must be the subject of a satisfactory inspection before the FDA or the regulators in other jurisdictions approve the product candidate manufactured at that facility. We are completely dependent on the current Good Manufacturing Practice requirements, or cGMPs, of these third-party manufacturers for compliance with the requirements of United States and non-United States regulators for the manufacture of our finished products. If our manufacturers cannot successfully manufacture material that conform to our specifications and cGMPs of any applicable governmental agency, our product candidates will not be approved or, if already approved, may be subject to recalls. Reliance on third-party manufacturers entails risks to which we would not be subject if we manufactured the product candidates, including:

Any of these factors could delay the approval or commercialization of our product candidates, cause us to incur higher costs or prevent us from commercializing our product candidates successfully. Furthermore, if any of our product candidates are approved and contract manufacturers fail to deliver the required commercial quantities of finished product on a timely basis and at commercially reasonable prices and we are unable to find one or more replacement manufacturers capable of production at a substantially equivalent cost, in substantially equivalent volumes and quality and on a timely basis, we would likely be unable to meet demand for our products and could lose potential revenue. It may take several years to establish an alternative source of supply for our product candidates and to have any such new source approved by the government agencies that regulate our products.

Our product candidates, if approved, will also be subject to ongoing regulatory requirements for labeling, packaging, storage, advertising, promotion, record-keeping and submission of safety and other post-market information. In addition, approved products, manufacturers and manufacturers’ facilities are required to comply with extensive FDA and EMA requirements and requirements of other similar agencies, including ensuring that quality control and manufacturing procedures conform to cGMPs. As such, we and our contract manufacturers are subject to continual review and periodic inspections to assess compliance with cGMPs. Accordingly, we and others with whom we work must continue to expend time, money and effort in all areas of regulatory compliance, including manufacturing, production and quality control. We will also be required to report certain adverse reactions and production problems, if any, to the FDA and EMA and other similar agencies and to comply with certain requirements concerning advertising and promotion for our products. Promotional communications with respect to prescription drugs are subject to a variety of legal and regulatory restrictions and must be consistent with the information in the product’s approved label. Accordingly, we may not promote our approved products, if any, for indications or uses for which they are not approved.

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, it may impose restrictions on that product or us, including requiring withdrawal of the product from the market. If our product candidates fail to comply with applicable regulatory requirements, the FDA and other regulatory agencies may:

The commercial success of BB3 or our other product candidates, if approved, will depend upon their acceptance among the medical community, including physicians, health care payors and patients. There are

no approved therapies for the treatment of DGF. There are no approved therapies for the treatment of AKI other than renal replacement therapy, or dialysis. There are no approved therapies for MI to reduce infarct size or prevent ventricular remodeling in conjunction with percutaneous coronary intervention, or angioplasty. In order for BB3 to be commercially successful, we will need to demonstrate that it is safe and effective for the treatment of patients with DGF, AKI and/or MI. The degree of market acceptance of our product candidates will depend on a number of factors, including:

If our product candidates are approved, but do not achieve an adequate level of acceptance by physicians, patients, the medical community and healthcare payors, sufficient revenue may not be generated from these products and we may not become or remain profitable. In addition, efforts to educate the medical community and third-party payors on the benefits of our product candidates may require significant resources and may never be successful.

We have no sales, marketing or distribution experience. To develop internal sales, distribution and marketing capabilities, we will have to invest significant amounts of financial and management resources, some of which will be committed prior to any confirmation that BB3 or any of our other product candidates will be approved. For product candidates where we decide to perform sales, marketing and distribution functions ourselves or through third parties, we could face a number of additional risks, including:

We have entered into a licensing agreement with Ohr Cosmetics LLC for the development and commercialization of our CYP inhibitor ANG-3522 for dermatological uses, including use as a topical, cosmetic product. Other compounds may be licensed or partnered with other third parties in the future. We may have limited or no control over the sales, marketing and distribution activities of these third parties. Our future revenues may depend heavily on the success of the efforts of these third parties.

To date, we have focused the majority of our development efforts on the development of BB3 for the prevention or treatment of DGF, a rare disease. One of our strategies is to pursue clinical development of BB3 for more common indications, including MI and AKI, to the extent that we have sufficient funding.

DGF is a rare disease and, as a result, the potential market size for treatments of DGF is limited. Therefore, our ability to grow revenues will be dependent on our ability to successfully develop and commercialize BB3 for the treatment of additional indications. We intend to continue our Phase 2 trial in MI patients using a portion of the proceeds from this offering. We will also start Phase 2 clinical trials in AKI patients using a portion of the proceeds from this offering. The completion of development, securing of approval and commercialization of BB3 for these additional indications will require substantial additional funding beyond the net proceeds of this offering and are prone to the risks of failure inherent in drug development. We cannot provide you any assurance that we will be able to successfully advance any of these indications through the development process. Even if we receive FDA approval to market BB3 for the treatment of any of these additional indications, we cannot assure you that any such additional indications will be successfully commercialized, widely accepted in the marketplace or more effective than other commercially available alternatives. If we are unable to successfully develop and commercialize BB3 for these additional indications, our commercial opportunity will be limited and our business prospects will suffer.

Product candidates in clinical stages of development have a high risk of failure. We cannot predict when or if BB3 will prove effective or safe in humans or will receive regulatory approval. Side effects could be identified as we expand our clinical trials for BB3 in DGF and to other indications. If new side effects are found during the development of BB3 for any indication, we may need to abandon our development of BB3 for DGF and other potential indications. We cannot assure you that additional or severe adverse side effects with respect to BB3 will not develop in future clinical trials, which could delay or preclude regulatory approval of BB3 or limit its commercial use.

Our research and development activities involve the controlled use of potentially harmful hazardous materials, including volatile solvents and chemicals that cause cancer. Our operations also produce hazardous waste products. We face the risk of contamination or injury from the use, storage, handling or disposal of these materials. We are subject to federal, state and local laws and regulations governing the use, storage, handling, and disposal of these materials and specified waste products. The cost of compliance with these laws and regulations could be significant, and current or future environmental regulations may impair our research, development, or production efforts. If one of our employees were accidentally injured from the use, storage, handling, or disposal of these materials, the medical costs related to his or her treatment would be covered by our workers’ compensation insurance policy. However, we do not carry specific hazardous waste insurance coverage and our general liability insurance policy specifically excludes coverage for damages and fines arising from hazardous waste exposure or contamination. Accordingly, in the event of contamination or injury, we could be subject to criminal sanctions or fines or be held liable for damages, our operating licenses could be revoked, or we could be required to suspend or modify our operations and our research and development efforts.

The biotechnology and pharmaceutical industries are intensely competitive and subject to rapid and significant technological change. We have competitors in the United States, Europe and other jurisdictions, including major multinational pharmaceutical companies, established biotechnology companies, specialty

pharmaceutical and generic drug companies and universities and other research institutions. Many of our competitors have greater financial and other resources, such as larger research and development staff and more experienced marketing and manufacturing organizations. Large pharmaceutical companies, in particular, have extensive experience in clinical testing, obtaining regulatory approvals, recruiting patients and manufacturing pharmaceutical products. These companies also have significantly greater research, sales and marketing capabilities and collaborative arrangements in our target markets with leading companies and research institutions. Established pharmaceutical companies may also invest heavily to accelerate discovery and development of novel compounds or to in-license novel compounds that could make the product candidates that we develop obsolete. As a result of all of these factors, our competitors may succeed in obtaining patent protection and/or FDA approval or discovering, developing and commercializing drugs for kidney, heart, liver and other diseases that we are targeting before we do. Smaller or early-stage companies may also prove to be significant competitors, particularly through collaborative arrangements with large, established companies. Some of the pharmaceutical and biotechnology companies we may compete with include Opsona Therapeutics, Sanofi, Novartis, Anges-MG, InterMune and Reata Pharmaceuticals. In addition, many universities and private and public research institutes may become active in our target disease areas. Our competitors may succeed in developing, acquiring or licensing on an exclusive basis, technologies and drug products that are more effective or less costly than BB3 or any other product candidates that we are currently developing or that we may develop, which could render our products obsolete and noncompetitive.

We believe that our ability to successfully compete will depend on, among other things:

If our competitors market products that are more effective, safer or less expensive than our future products, if any, or that reach the market sooner than our future products, if any, we may not achieve commercial success. In addition, the biopharmaceutical industry is characterized by rapid technological change. Because our research approach integrates many technologies, it may be difficult for us to stay abreast of the rapid changes in each technology. If we fail to stay at the forefront of technological change, we may be unable to compete effectively. Technological advances or products developed by our competitors may render our technologies or product candidates obsolete, less competitive or not economical.

We outsource substantial portions of our operations to third-party service providers, including the conduct of preclinical studies and clinical trials, collection and analysis of data and manufacturing. Our agreements with third-party service providers and CROs are on a study-by-study and project-by-project

basis. Typically, we may terminate the agreements with notice and are responsible for the supplier’s previously incurred costs. In addition, any CRO that we retain will be subject to the FDA’s and EMA’s regulatory requirements and similar standards outside of the United States and Europe, and we do not have control over compliance with these regulations by these providers. Consequently, if these providers do not adhere to applicable governing practices and standards, the development and commercialization of our product candidates could be delayed or stopped, which could severely harm our business and financial condition.

Because we have relied on third parties, our internal capacity to perform these functions is limited to management oversight. Outsourcing these functions involves the risk that third parties may not perform to our standards, may not produce results in a timely manner or may fail to perform at all. We and our consultants monitor our third parties for performance and adherence to protocols. We have had to replace clinical sites because of poor enrollment. In addition, the use of third-party service providers requires us to disclose our proprietary information to these parties, which could increase the risk that this information will be misappropriated. There are a limited number of third-party service providers that specialize in or have the expertise required to achieve our business objectives. Identifying, qualifying and managing performance of third-party service providers can be difficult, time consuming and cause delays in our development programs. We currently have a small number of employees, which limits the internal resources we have available to identify and monitor third-party service providers. To the extent we are unable to identify, retain and successfully manage the performance of third-party service providers in the future, our business may be adversely affected, and we may be subject to the imposition of civil or criminal penalties if their conduct of clinical trials violates applicable law.

As we increase the number of ongoing product development programs and advance our product candidates through preclinical studies and clinical trials, we will need to increase our product development, scientific and administrative headcount to manage these programs. In addition, to meet our obligations as a public company, we will need to increase our general and administrative capabilities. Our management, personnel and systems currently in place may not be adequate to support this future growth. Our need to effectively manage our operations, growth and various projects requires that we:

If we are unable to successfully manage this growth and increased complexity of operations, our business may be adversely affected.

We may not be able to attract or retain qualified management, finance, scientific and clinical personnel and consultants due to the intense competition for qualified personnel and consultants among biotechnology, pharmaceutical and other businesses. If we are not able to attract and retain necessary personnel and consultants to accomplish our business objectives, we may experience constraints that will significantly impede the achievement of our development objectives, our ability to raise additional capital and our ability to implement our business strategy.

Our industry has experienced a high rate of turnover of management personnel in recent years. We are highly dependent on the development, regulatory, commercialization and business development expertise of Itzhak D. Goldberg, M.D., F.A.C.R., our founder, president and chief executive officer, our three vice

presidents, our senior principal investigators, our clinical study principal investigators and our regulatory consultants, among others. If we lose one or more of our executive officers or key employees or consultants, our ability to implement our business strategy successfully could be seriously harmed. Any of our executive officers or key employees or consultants may terminate their employment and/or engagement with us at any time. Replacing executive officers, key employees and consultants may be difficult and may take an extended period of time because of the limited number of individuals in our industry with the breadth of skills and experience required to develop, gain regulatory approval of and commercialize products successfully. Competition to hire and retain employees and consultants from this limited pool is intense, and we may be unable to hire, train, retain or motivate these additional key personnel and consultants. Our failure to retain key personnel or consultants could materially harm our business.

We have scientific and clinical advisors and consultants who assist us in formulating our research, development and clinical strategies. These advisors are not our employees and may have commitments to, or consulting or advisory contracts with, other entities that may limit their availability to us and typically they will not enter into non-compete agreements with us. If a conflict of interest arises between their work for us and their work for another entity, we may lose their services. In addition, our advisors may have arrangements with other companies to assist those companies in developing products or technologies that may compete with ours.

As a public company, we will operate in an increasingly demanding regulatory environment, which requires us to comply with the Sarbanes-Oxley Act of 2002, and the related rules and regulations of the SEC and NASDAQ, expanded disclosure requirements, accelerated reporting requirements and more complex accounting rules. Company responsibilities required by the Sarbanes-Oxley Act include establishing corporate oversight and adequate internal control over financial reporting and disclosure controls and procedures. Effective internal controls are necessary for us to produce reliable financial reports and are important to help prevent financial fraud.

We are in the process of implementing a system of internal controls over financial reporting and preparing the documentation necessary to perform the evaluation needed to comply with Section 404(a) of the Sarbanes-Oxley Act. However, we anticipate that we will need to retain additional finance capabilities and build our financial infrastructure as we transition to operating as a public company, including complying with the requirements of Section 404 of the Sarbanes-Oxley Act. As we begin operating as a public company following this offering, we will continue improving our financial infrastructure with the retention of additional financial and accounting capabilities, the enhancement of internal controls and additional training for our financial and accounting staff.

Section 404(a) of the Sarbanes-Oxley Act requires annual management assessments of the effectiveness of our internal control over financial reporting, starting with the second annual report that we would expect to file with the SEC. However, for as long as we remain an “emerging growth company” as defined in the JOBS Act, we intend to take advantage of certain exemptions from various reporting requirements that are applicable to other public companies that are not “emerging growth companies” including, but not limited to, not being required to comply with the auditor attestation requirements of Section 404(b) of the Sarbanes-Oxley Act. We may take advantage of these reporting exemptions until we are no longer an “emerging growth company.” We will remain an “emerging growth company” until the earliest of (i) the last day of the fiscal year in which we have total annual gross revenues of $1.0 billion or more; (ii) the last day of our fiscal year following the fifth anniversary of the date of the completion of this offering; (iii) the date on which we have issued more than $1.0 billion in nonconvertible debt during the previous three years; or (iv) the date on which we are deemed to be a large accelerated filer under the rules of the SEC.

Until we are able to expand our finance and administrative capabilities and establish necessary financial reporting infrastructure, we may not be able to prepare and disclose, in a timely manner, our financial statements and other required disclosures or comply with the Sarbanes-Oxley Act or existing or new reporting requirements. If we cannot provide reliable financial reports or prevent fraud, our business and results of operations could be harmed, we may not be current in our required periodic SEC and NASDAQ reporting subject to possible proceedings or delisting, and investors could lose confidence in our reported financial information.

We are exposed to the risk of employee fraud or other misconduct. Misconduct by employees could include intentional failures to comply with the regulations of the FDA and non-United States regulators, provide accurate information to the FDA and non-United States regulators, comply with health care fraud and abuse laws and regulations in the United States and abroad, report financial information or data accurately or disclose unauthorized activities to us. In particular, sales, marketing and business arrangements in the health care industry are subject to extensive laws and regulations intended to prevent fraud, misconduct, kickbacks, self-dealing and other abusive practices. These laws and regulations may restrict or prohibit a wide range of pricing, discounting, marketing and promotion, sales commission, customer incentive programs and other business arrangements. Employee misconduct could also involve the improper use of information obtained in the course of clinical trials, which could result in regulatory sanctions and serious harm to our reputation. We intend to adopt a code of conduct, but it is not always possible to identify and deter employee misconduct, and the precautions we take to detect and prevent this activity may not be effective in controlling unknown or unmanaged risks or losses or in protecting us from governmental investigations or other actions or lawsuits stemming from a failure to comply with these laws or regulations. If any such actions are instituted against us, and we are not successful in defending ourselves or asserting our rights, those actions could have a significant impact on our business, including the imposition of significant fines or other sanctions.

The use of our product candidates in clinical trials and the sale of any products for which we may obtain marketing approval expose us to the risk of product liability claims. Product liability claims may be brought against us or our collaborators by participants enrolled in our clinical trials, patients, health care providers or others using, administering or selling our products. If we cannot successfully defend ourselves against any such claims, we would incur substantial liabilities. Regardless of merit or eventual outcome, product liability claims may result in:

We have obtained limited product liability insurance coverage for our clinical trials in the United States and in selected other jurisdictions where we are conducting clinical trials. Our product liability insurance coverage for clinical trials in the United States is currently limited to an aggregate of $5.0 million and outside of the United States we have coverage for lesser amounts that vary by country. As such, our insurance coverage may not reimburse us or may not be sufficient to reimburse us for any expenses or losses we may suffer. Moreover, insurance coverage is becoming increasingly expensive, and, in the future, we may not be able to maintain insurance coverage at a reasonable cost or in sufficient amounts to protect us against losses due to product liability. We intend to expand our insurance coverage for products to include the sale of commercial products if we obtain marketing approval for our product candidates in development, but we may be unable to obtain commercially reasonable product liability insurance for any products approved for marketing. Large judgments have been awarded in class action lawsuits based on drugs that had unanticipated side effects. A successful product liability claim or series of claims brought against us, particularly if judgments exceed our insurance coverage, could decrease our cash resources and adversely affect our business.

We do not carry insurance for all categories of risk that our business may encounter. Some of the policies we currently maintain include property, general liability, employment benefits liability, business automobile, workers’ compensation, products liability and clinical trials (U.S and foreign), and directors’ and officers’, employment practices and fiduciary liability insurance. We do not know, however, if we will be able to maintain insurance with adequate levels of coverage. Any significant uninsured liability may require us to pay substantial amounts, which would adversely affect our financial position and results of operations.

From time to time we have considered, and we will continue to consider in the future, strategic business initiatives intended to further the expansion and development of our business. These initiatives may include acquiring businesses, technologies or products or entering into a business combination with another company. If we pursue such a strategy, we could, among other things:

Although we intend to evaluate and consider acquisitions, reorganizations and business combinations in the future, we have no agreements or understandings with respect to any acquisition, reorganization or business combination at this time.

Our financial statements have been prepared on the basis that we will continue as a going concern. We have been funded through grants from the National Institute of Health and other United States government agencies. Each grant award specifies a total dollar amount and term that that we can draw in the advancement of such projects. As of December 31, 2013, we have approximately $4.8 million remaining under awards granted. Our current grant funding substantially expires in the summer of 2014, and therefore our ability to support our operating costs without additional grant funding and/or external financing, raise substantial doubt about our ability to continue as a going concern. We have applied for significant grant awards or renewals, however, there is no assurance that we will be successful in receiving such awards.

We expect to incur significant expenses to complete clinical work and to prepare BB3 for Phase 3 trials in the United States. We may never be able to obtain regulatory approval for the marketing of BB3 or other products in the United States or internationally, and even if we are able to commercialize BB3 or any other product candidate, there can be no assurance we will generate significant revenues or ever achieve profitability. We also expect that our research and development expenses will continue to increase as we move forward with our clinical testing for BB3 and perform other trials for its diverse research and development portfolio. As a result, we expect to continue to incur substantial losses for the foreseeable future, and these losses will be increasing. We will not commence the Phase 3 clinical trial of BB3 for DGF, the Phase 2 trial for Acute Kidney Injury, or continue the Phase 2 for Myocardial Infarction unless we receive the proceeds of a contemplated initial public offering or other significant funding. Further, in the event that we do not receive additional grant awards or renewals, we will be forced to eliminate certain sub-contractors contracts and infrastructure costs.

The accompanying financial statements do not include any adjustments that may be necessary should we be unable to continue as a going concern. It is not possible for us to predict at this time the potential success of our business. The revenue and income potential of our proposed business and operations are currently unknown. If we cannot continue as a viable entity, you may lose some or all of your investment in our company.

Our commercial success will depend in part on obtaining and maintaining patent protection and trade secret protection of our current and future product candidates and the methods used to manufacture them, as well as successfully defending these patents against third-party challenges. Our ability to stop third parties from making, using, selling, offering to sell or importing our product candidates is dependent upon the extent to which we have rights under valid and enforceable patents or trade secrets that cover these activities. The patent positions of biotechnology and pharmaceutical companies can be highly uncertain and involve complex legal and factual questions for which important legal principles remain unresolved. No consistent policy regarding the breadth of claims allowed in pharmaceutical patents has emerged to date in the United States or in many jurisdictions outside of the United States. Changes in either the patent laws or interpretations of patent laws in the United States and other countries may diminish the value of our intellectual property. Accordingly, we cannot predict the breadth of claims that may be enforced in the patents that may be issued from the applications we currently or may in the future own or license from third parties. Further, if any patents we obtain or license are deemed invalid and unenforceable, our ability to commercialize or license our technology could be adversely affected.

Others have filed, and in the future are likely to file, patent applications covering products and technologies that are similar, identical or competitive to ours or important to our business. We cannot be certain that any patent application owned by a third party will not have priority over patent applications filed or in-licensed by us, or that we or our licensors will not be involved in interference, opposition or invalidity proceedings before United States or non-United States patent offices.

The degree of future protection for our proprietary rights is uncertain because legal means afford only limited protection and may not adequately protect our rights or permit us to gain or keep our competitive advantage. For example:

As of December 31, 2013, we were the owner of 11 issued or granted United States and non-United States patents relating to BB3 and BB3 analogues; with respect to BB3, the claims are directed to pharmaceutical compositions, formulations and methods of using these compounds for various indications,

and with respect to the BB3 analogues, the claims directed to pharmaceutical compounds, pharmaceutical compositions, formulations and methods of using these compounds for various indications. We were also the owner of 21 pending United States and non-United States patent applications relating to BB3 and BB3 analogues in these areas.

In addition, as of December 31, 2013, we were the owner of 1 issued United States patent relating to our product candidates other than BB3 described in development programs in this prospectus, with claims directed to pharmaceutical compounds, pharmaceutical compositions and methods of using these compounds for various indications. We were also the owner of 12 pending United States and non-United States patent applications including international patent applications relating to such other product candidates in these program areas.

Patents covering the BB3 pharmaceutical compositions expire during 2023 and 2024 if the appropriate maintenance fee renewal, annuity, or other government fees are paid. We expect that the other patents and patent applications for the BB3 portfolio, if issued, and if the appropriate maintenance, renewal, annuity or other governmental fees are paid, would expire between 2023 and 2031. We expect the issued CYP inhibitor composition-of-matter patent in the United States, if the appropriate maintenance fee, renewal, annuity, or other governmental fees are paid, to expire in 2031. We expect the other pending patent applications in the dual kinase inhibitor portfolio, if issued, and if the appropriate maintenance, renewal, annuity or other governmental fees are paid, could expire in 2033. These expirations are exclusive of any patent term extension available resulting from regulatory delays.

Without patent protection on the composition of matter, pharmaceutical compositions or formulations of our product candidates, our ability to assert our patents to stop others from using or selling our product may be limited.

Due to the patent laws of a country, or the decisions of a patent examiner in a country, or our own filing strategies, we may not obtain patent coverage for all of our product candidates or methods involving these candidates in the parent patent application. We plan to pursue divisional patent applications or continuation patent applications in the United States and other countries to obtain claim coverage for inventions which were disclosed but not claimed in the parent patent application.

We may also rely on trade secrets to protect our technology, especially where we do not believe patent protection is appropriate or feasible. However, trade secrets are difficult to protect. Although we use reasonable efforts to protect our trade secrets, our employees, consultants, contractors, outside scientific collaborators and other advisors may unintentionally or willfully disclose our information to competitors. Enforcing a claim that a third party illegally obtained and is using any of our trade secrets is expensive and time consuming, and the outcome is unpredictable. In addition, courts outside the United States are sometimes less willing to protect trade secrets. Moreover, our competitors may independently develop equivalent knowledge, methods and know-how.

If we choose to go to court to stop another party from using the inventions claimed in any patents we obtain, that individual or company has the right to ask the court to rule that such patents are invalid or should not be enforced against that third party. These lawsuits are expensive and would consume time and resources and divert the attention of managerial and scientific personnel even if we were successful in stopping the infringement of such patents. In addition, there is a risk that the court will decide that such patents are not valid and that we do not have the right to stop the other party from using the inventions. There is also a risk that, even if the validity of such patents is upheld, the court will refuse to stop the other party on the ground that such other party’s activities do not infringe our rights to such patents. In addition, the United States Supreme Court has recently modified some tests used by the United States Patent and Trademark Office, or USPTO, in granting patents over the past 20 years, which may decrease the likelihood that we will be able to obtain patents and increase the likelihood of challenge of any patents we obtain or license.

Our success will depend in part on our ability to operate without infringing the proprietary rights of third parties. We cannot guarantee that our products, or manufacture or use of our product candidates, will not infringe third-party patents. Furthermore, a third party may claim that we or our manufacturing or commercialization collaborators are using inventions covered by the third party’s patent rights and may go to court to stop us from engaging in our normal operations and activities, including making or selling our product candidates. These lawsuits are costly and could affect our results of operations and divert the attention of managerial and scientific personnel. There is a risk that a court would decide that we or our commercialization collaborators are infringing the third party’s patents and would order us or our collaborators to stop the activities covered by the patents. In that event, we or our commercialization collaborators may not have a viable way around the patent and may need to halt commercialization of the relevant product. In addition, there is a risk that a court will order us or our collaborators to pay the other party damages for having violated the other party’s patents. In the future, we may agree to indemnify our commercial collaborators against certain intellectual property infringement claims brought by third parties. The pharmaceutical and biotechnology industries have produced a proliferation of patents, and it is not always clear to industry participants, including us, which patents cover various types of products or methods of use. The coverage of patents is subject to interpretation by the courts, and the interpretation is not always uniform.

If we are sued for patent infringement, we would need to demonstrate that our products or methods either do not infringe the patent claims of the relevant patent or that the patent claims are invalid, and we may not be able to do this. Proving invalidity is difficult. For example, in the United States, proving invalidity requires a showing of clear and convincing evidence to overcome the presumption of validity enjoyed by issued patents. Even if we are successful in these proceedings, we may incur substantial costs and divert management’s time and attention in pursuing these proceedings, which could have a material adverse effect on us. If we are unable to avoid infringing the patent rights of others, we may be required to seek a license, which may not be available, defend an infringement action or challenge the validity of the patents in court. Patent litigation is costly and time consuming. We may not have sufficient resources to bring these actions to a successful conclusion. In addition, if we do not obtain a license, develop or obtain non-infringing technology, fail to defend an infringement action successfully or have infringed patents declared invalid, we may incur substantial monetary damages, encounter significant delays in bringing our product candidates to market and be precluded from manufacturing or selling our product candidates.

We cannot be certain that others have not filed patent applications for technology covered by our pending applications, or that we were the first to invent the technology, because:

Our competitors may have filed, and may in the future file, patent applications covering technology similar to ours. Any such patent application may have priority over our patent applications, which could further require us to obtain rights to issued patents covering such technologies. If another party has filed a United States patent application on inventions similar to ours, we may have to participate in an interference proceeding declared by the USPTO 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 if, unbeknownst to us, the other party had independently arrived at the same or similar invention prior to our own invention, resulting in a loss of our United States patent position with respect to such inventions. Other countries have similar laws that permit secrecy of patent applications, and may be entitled to priority over our applications in such jurisdictions.

Some of our competitors may be able to sustain the costs of complex patent litigation more effectively than we 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 our ability to raise the funds necessary to continue our operations.

Periodic maintenance fees, renewal fees, annuity fees and various other governmental fees on patents and/or applications will be due to be paid to the USPTO and various governmental patent agencies outside of the United States in several stages over the lifetime of the patents and/or applications. We have systems in place to remind us to pay these fees, and we employ an outside firm and rely on our outside counsel to pay these fees due to non-United States patent agencies. The USPTO and various non-United States governmental patent agencies require compliance with a number of procedural, documentary, fee payment and other similar provisions during the patent application process. We employ reputable law firms and other professionals to help us comply, and in many cases, an inadvertent lapse can be cured by payment of a late fee or by other means in accordance with the applicable rules. However, there are situations in which noncompliance can result in abandonment or lapse of the patent or patent application, resulting in partial or complete loss of patent rights in the relevant jurisdiction. In such an event, our competitors might be able to enter the market and this circumstance would have a material adverse effect on our business.

As is common in the biotechnology and pharmaceutical industries, we employ individuals who were previously employed at other biotechnology or pharmaceutical companies, including our competitors or potential competitors. We may be subject to claims that these employees, or we, have inadvertently or otherwise used or disclosed trade secrets or other proprietary information of their former employers. Litigation may be necessary to defend against these claims. Even if we are successful in defending against these claims, litigation could result in substantial costs and be a distraction to management.

We rely on trade secrets to protect our proprietary technologies, especially where we do not believe patent protection is appropriate or obtainable. However, trade secrets are difficult to protect. We rely in part on confidentiality agreements with our employees, consultants, outside scientific collaborators, sponsored researchers and other advisors to protect our trade secrets and other proprietary information. These agreements may not effectively prevent disclosure of confidential information and may not provide an adequate remedy in the event of unauthorized disclosure of confidential information. In addition, others may independently discover our trade secrets and proprietary information. For example, the FDA, as part of its Transparency Initiative, is currently considering whether to make additional information publicly available on a routine basis, including information that we may consider to be trade secrets or other proprietary information, and it is not clear at the present time how the FDA’s disclosure policies may change in the future, if at all. Costly and time-consuming litigation could be necessary to enforce and determine the scope of our proprietary rights, and failure to obtain or maintain trade secret protection could adversely affect our competitive business position.

Prior to this offering, there has been no public market for our common stock. An active trading market may not develop following the completion of this offering or, if developed, may not be sustained. The lack of an active market may also reduce the fair market value of your shares. An inactive market may also impair our ability to raise capital to continue to fund operations by selling shares and may impair our ability to acquire other companies or technologies by using our shares as consideration.

The initial public offering price for our shares will be determined by negotiations between us and the underwriter and may not be indicative of prices that will prevail in the trading market. The market price of shares of our common stock could be subject to wide fluctuations in response to many risk factors listed in this section, and others beyond our control, including:

Furthermore, the stock markets have experienced extreme price and volume fluctuations that have affected and continue to affect the market prices of equity securities of many companies. These fluctuations often have been unrelated or disproportionate to the operating performance of those companies. These broad market and industry fluctuations, as well as general economic, political and market conditions such as recessions, interest rate changes or international currency fluctuations, may negatively impact the market price of shares of our common stock. In addition, such fluctuations could subject us to securities class action litigation, which could result in substantial costs and divert our management’s attention from other business concerns, which could seriously harm our business. If the market price of shares of our common stock after this offering does not exceed the initial public offering price, you may not realize any return on your investment in us and may lose some or all of your investment.

Our chief executive officer, who is also a member of our board of directors, beneficially owns a substantial percentage of our outstanding equity securities. Accordingly, such officer will be able to make all business decisions, including with respect to such matters as amendments to our charter, other fundamental corporate transactions, such as mergers, asset sales and the sale of the Company, and otherwise will be able to direct our business and affairs.

We intend to use substantially all of the net proceeds from this offering to fund (i) the continued clinical development of BB3 in renal transplantation, including Phase 3 trials and other trials necessary for anticipated FDA and EMA filings; (ii) the continuation and completion of Phase 2 trials on BB3 in acute myocardial infarction; (iii) the completion of a Phase 2 clinical trial in acute kidney injury; (iv) the completion of preclinical development of ANG-3070 and IND submission to the FDA; (v) the completion

of preclinical development of ANG-3281 and an IND submission to the FDA; and (vi) continuing discovery work on our CYP selectively targeted inhibitor platform, relaxin mimetic peptides and relaxin delivery system and other discovery projects, with the goal to advance candidates into preclinical development. Any remaining amounts will be used for general corporate purposes, general and administrative expenses, capital expenditures, working capital and prosecution and maintenance of our intellectual property. Although we currently intend to use the net proceeds from this offering in such a manner, we will have broad discretion in the application of the net proceeds. Our failure to apply these funds effectively could affect our ability to continue to develop and commercialize our product candidates.

As a public company, we will incur significant legal, insurance, accounting and other expenses that we did not incur as a private company. In addition, our administrative staff will be required to perform additional tasks. For example, in anticipation of becoming a public company, we will need to adopt additional internal controls and disclosure controls and procedures, retain a transfer agent, adopt an insider trading policy and bear all of the internal and external costs of preparing and distributing periodic public reports in compliance with our obligations under the securities laws.

In addition, laws, regulations and standards applicable to public companies relating to corporate governance and public disclosure, including the Sarbanes-Oxley Act and related regulations implemented by the SEC and the NASDAQ Stock Market, are creating uncertainty for public companies, increasing legal and financial compliance costs and making some activities more time consuming. These laws, regulations and standards are subject to varying interpretations, in many cases due to their lack of specificity, and, as a result, their application in practice may evolve over time as new guidance is provided by regulatory and governing bodies. This could result in continuing uncertainty regarding compliance matters and higher costs necessitated by ongoing revisions to disclosure and governance practices. We intend to invest resources to comply with evolving laws, regulations and standards, and this investment will result in increased general and administrative expenses and may divert management’s time and attention from product development activities. If our efforts to comply with new laws, regulations and standards differ from the activities intended by regulatory or governing bodies due to ambiguities related to practice, regulatory authorities may initiate legal proceedings against us and our business may be harmed. In connection with this offering, we are increasing our directors’ and officers’ insurance coverage, which will increase our insurance cost. In the future, it will be more expensive for us to obtain director and officer liability insurance, and we may be required to accept reduced coverage or incur substantially higher costs to obtain coverage. These factors could also make it more difficult for us to attract and retain qualified members of our board of directors, particularly to serve on our audit committee and compensation committee, and qualified executive officers.

We are an “emerging growth company,” as defined in the Jumpstart Our Business Startups Act of 2012, or the JOBS Act, and we intend to take advantage of certain exemptions from various reporting requirements that are applicable to other public companies that are not “emerging growth companies” including not being required to comply with the auditor attestation requirements of Section 404(b) of the Sarbanes-Oxley Act, reduced disclosure obligations regarding executive compensation in our periodic reports and proxy statements, and exemptions from the requirements of holding a nonbinding advisory vote on executive compensation and stockholder approval of any golden parachute payments not previously approved. We cannot predict if investors will find our common stock less attractive because we may rely on these exemptions. If some investors find our common stock less attractive as a result, there may be a less active trading market for our common stock and our stock price may be more volatile. We may take advantage of these reporting exemptions until we are no longer an “emerging growth company.” We will remain an “emerging growth company” until the earliest of (i) the last day of the fiscal year in which we have total annual gross revenues of $1.0 billion or more; (ii) the last day of our fiscal year following the fifth anniversary of the date of the completion of this offering; (iii) the date on which we have issued more than $1.0 billion in nonconvertible debt during the previous three years; or (iv) the date on which we are deemed to be a large accelerated filer under the rules of the SEC.

The initial public offering price will be substantially higher than the net tangible book value per share of shares of our common stock based on the total value of our tangible assets less our total liabilities immediately following this offering. Therefore, if you purchase shares of our common stock in this offering, you will experience immediate and substantial dilution of $     per share in the price you pay for shares of our common stock as compared to its pro forma as adjusted net tangible book value, assuming an initial public offering price of $     per share, the mid-point of the price range set forth on the cover page of this prospectus. To the extent outstanding options or warrants to purchase shares of common stock that are in the money are exercised, there will be further dilution. For further information on this calculation, see “Dilution” elsewhere in this prospectus.

We expect that significant additional capital will be needed in the future to continue our planned operations. To the extent we raise additional capital by issuing equity securities, our stockholders may experience substantial dilution. We may sell common stock, convertible securities or other equity securities in one or more transactions at prices and in a manner we determine from time to time. If we sell common stock, convertible securities or other equity securities in more than one transaction, investors may be materially diluted by subsequent sales. Such sales may also result in material dilution to our existing stockholders, and new investors could gain rights superior to our existing stockholders.

As of December 31, 2013, we had issued options to purchase 3,775 shares outstanding under our 2002 Stock Option Plan. Furthermore, we plan to adopt a new equity incentive plan prior to the completion of this offering. Sales of shares granted under our 2002 Stock Option Plan and our proposed equity incentive plan, if adopted, may result in material dilution to our existing stockholders, which could cause our share price to fall.

The trading market for our common stock will depend on the research and reports that securities or industry analysts publish about us or our business. We do not have any control over these analysts. There can be no assurance that analysts will cover us or provide favorable coverage. If one or more of the analysts who cover us downgrade our stock or change their opinion of our stock, our share price would likely decline. If one or more of these analysts cease coverage of our company or fail to regularly publish reports on us, we could lose visibility in the financial markets, which could cause our share price or trading volume to decline.

We have applied to list our common stock on the NASDAQ Capital Market. In order to make a final determination of compliance with their listing criteria, NASDAQ may look to the first trading day’s activity and, particularly, the last bid price on such day. In the event the trading price for our common stock drops below the NASDAQ Capital Market’s minimum bid requirement, NASDAQ could rescind our initial listing approval. If that were to happen, the liquidity for our common stock would decrease. If we failed to list the stock on the NASDAQ Capital Market, the liquidity for our common stock would be significantly impaired, which may substantially decrease the trading price of our common stock.

In addition, we cannot assure you that, in the future, our securities will meet the continued listing requirements to be listed on NASDAQ. If NASDAQ delists our common stock from trading on its exchange, we could face significant material adverse consequences, including:

The SEC has adopted rules that regulate broker-dealer practices in connection with transactions in penny stocks. Penny stocks are generally equity securities with a price of less than $5.00, other than securities registered on certain national securities exchanges or authorized for quotation on certain automated quotation systems, provided that current price and volume information with respect to transactions in such securities is provided by the exchange or system. If we do not obtain or retain a listing on The NASDAQ Capital Market, and if the price of our common stock is less than $5.00, our common stock will be deemed a penny stock. The penny stock rules require a broker-dealer, before a transaction in a penny stock not otherwise exempt from those rules, to deliver a standardized risk disclosure document containing specified information. In addition, the penny stock rules require that before effecting any transaction in a penny stock not otherwise exempt from those rules, a broker-dealer must make a special written determination that the penny stock is a suitable investment for the purchaser and receive (i) the purchaser’s written acknowledgment of the receipt of a risk disclosure statement; (ii) a written agreement to transactions involving penny stocks; and (iii) a signed and dated copy of a written suitability statement. These disclosure requirements may have the effect of reducing the trading activity in the secondary market for our common stock, and therefore stockholders may have difficulty selling their shares.

Provisions in our restated certificate of incorporation and bylaws that will be effective upon the completion of this offering, as well as provisions of Delaware law, could make it more difficult for a third party to acquire us or increase the cost of acquiring us, even if doing so would benefit our stockholders. These provisions include:

These provisions may also frustrate or prevent any attempts by our stockholders to replace or remove our current management or members of our board of directors. In addition, we are subject to Section 203 of the Delaware General Corporation Law, which generally prohibits a Delaware corporation from engaging in any of a broad range of business combinations with an interested stockholder for a period of three years following the date on which the stockholder became an interested stockholder, unless such transactions are approved by our board of directors. This provision could have the effect of delaying or preventing a change of control, whether or not it is desired by or beneficial to our stockholders. Further, other provisions of Delaware law may also discourage, delay or prevent someone from acquiring us or merging with us.

As permitted by Section 102(b)(7) of the Delaware General Corporation Law, our restated certificate of incorporation to be in effect upon the completion of this offering will limit the liability of our directors

to the fullest extent permitted by law. In addition, as permitted by Section 145 of the Delaware General Corporation Law, our restated certificate of incorporation and restated bylaws to be in effect upon the completion of this offering will provide that we shall indemnify, to the fullest extent authorized by the Delaware General Corporation Law, each person who is involved in any litigation or other proceeding because such person is or was a director or officer of our company or is or was serving as an officer or director of another entity at our request, against all expense, loss or liability reasonably incurred or suffered in connection therewith. Our restated certificate of incorporation to be in effect upon the completion of this offering will provide that the right to indemnification includes the right to be paid expenses incurred in defending any proceeding in advance of its final disposition, provided, however, that such advance payment will only be made upon delivery to us of an undertaking, by or on behalf of the director or officer, to repay all amounts so advanced if it is ultimately determined that such director is not entitled to indemnification. If we do not pay a proper claim for indemnification in full within 60 days after we receive a written claim for such indemnification, except in the case of a claim for an advancement of expenses, in which case such period is 20 days, our restated certificate of incorporation and our restated bylaws authorize the claimant to bring an action against us and prescribe what constitutes a defense to such action.

Section 145 of the Delaware General Corporation Law permits a corporation to indemnify any director or officer of the corporation against expenses (including attorney’s fees), judgments, fines and amounts paid in settlement actually and reasonably incurred in connection with any action, suit or proceeding brought by reason of the fact that such person is or was a director or officer of the corporation, if such person acted in good faith and in a manner that he reasonably believed to be in, or not opposed to, the best interests of the corporation, and, with respect to any criminal action or proceeding, if he or she had no reason to believe his or her conduct was unlawful. In a derivative action, (i.e., one brought by or on behalf of the corporation), indemnification may be provided only for expenses actually and reasonably incurred by any director or officer in connection with the defense or settlement of such an action or suit if such person acted in good faith and in a manner that he or she reasonably believed to be in, or not opposed to, the best interests of the corporation, except that no indemnification shall be provided if such person shall have been adjudged to be liable to the corporation, unless and only to the extent that the court in which the action or suit was brought shall determine that the defendant is fairly and reasonably entitled to indemnity for such expenses despite such adjudication of liability.

The rights conferred in the restated certificate of incorporation and the restated bylaws are not exclusive, and we are authorized to enter into indemnification agreements with our directors, officers, employees and agents and to obtain insurance to indemnify such persons. We have entered into or plan to enter into indemnification agreements with each of our officers and directors, the form of which is attached as an exhibit to the registration statement of which this prospectus is a part.

The above limitations on liability and our indemnification obligations limit the personal liability of our directors and officers for monetary damages for breach of their fiduciary duty as directors by shifting the burden of such losses and expenses to us. Although we obtained coverage under our directors’ and officers’ liability insurance, certain liabilities or expenses covered by our indemnification obligations may not be covered by such insurance or the coverage limitation amounts may be exceeded. As a result, we may need to use a significant amount of our funds to satisfy our indemnification obligations, which could severely harm our business and financial condition and limit the funds available to stockholders who may choose to bring a claim against our company.

We do not anticipate paying cash dividends in the future. As a result, only appreciation of the market price of our common stock, which may never occur, will provide a return to stockholders. Investors seeking cash dividends should not invest in our common stock.

This prospectus contains forward-looking statements. All statements other than statements of historical facts contained in this prospectus, including statements regarding our strategy, future operations, future financial position, future revenue, projected costs, prospects, plans, objectives of management and expected market growth are forward-looking statements. These statements involve known and unknown risks, uncertainties and other important factors that may cause our actual results, performance or achievements to be materially different from any future results, performance or achievements expressed or implied by the forward-looking statements. The words “anticipate,” “believe,” “could,” “estimate,” “expect,” “intend,” “may,” “plan,” “potential,” “predict,” “project,” “should,” “target,” “will,” “would” and similar expressions are intended to identify forward-looking statements, although not all forward-looking statements contain these identifying words. These forward-looking statements include, but are not limited to, statements about:

These forward-looking statements are only predictions and we may not actually achieve the plans, intentions or expectations disclosed in our forward-looking statements, so you should not place undue reliance on our forward-looking statements. Actual results or events could differ materially from the plans, intentions and expectations disclosed in the forward-looking statements we make. We have based these forward-looking statements largely on our current expectations and projections about future events and trends that we believe may affect our business, financial condition and operating results. We have included important factors in the cautionary statements included in this prospectus, particularly in the “Risk Factors” section, that could cause actual future results or events to differ materially from the forward-looking statements that we make. Our forward-looking statements do not reflect the potential impact of any future acquisitions, mergers, dispositions, joint ventures or investments we may make.

The forward-looking statements in this prospectus represent our views as of the date of this prospectus. We anticipate that subsequent events and developments will cause our views to change. However, while we may elect to update these forward-looking statements at some point in the future, we have no current intention of doing so except to the extent required by applicable law. You should, therefore, not rely on these forward-looking statements as representing our views as of any date subsequent to the date of this prospectus.

We estimate that our net proceeds from the sale of              shares of common stock in this offering will be approximately $             million, assuming an initial public offering price of $             per share, the mid-point of the price range set forth on the cover page of this prospectus and after deducting underwriting discounts and commissions and estimated offering expenses payable by us. If the over-allotment option is exercised in full, we estimate that our net proceeds will be approximately $             million. A $1.00 increase (decrease) in the assumed initial public offering price per share of $            , the mid-point of the price range set forth on the cover page of this prospectus, would increase (decrease) the net proceeds to us from this offering by approximately $             million, assuming the number of shares offered by us, as set forth on the cover page of this prospectus, remains the same and after deducting underwriting discounts and estimated offering expenses payable by us. We may also increase or decrease the number of shares we are offering. Each increase (decrease) of 1.0 million in the number of shares we are offering would increase (decrease) the net proceeds to us from this offering, after deducting the estimated underwriting discounts and commissions and estimated offering expenses payable by us, by approximately $             million, assuming the assumed initial public offering price stays the same.

The principal purposes of this offering are to obtain additional capital to support our operations, to create a public market for our common stock and to facilitate our future access to the public equity markets. We intend to use the net proceeds from this offering as follows:

We believe that the intended net proceeds from this offering and continued grant funding, together with interest on cash balances, will be sufficient to fund the continued development of our clinical candidates through at least the first quarter of 2016. The amount and timing of our actual expenditures will depend upon numerous factors, including the status and results of the ongoing Phase 2 trials. Furthermore, we anticipate that we will need to secure additional funding for the further development of BB3 for acute kidney injury and myocardial infarction, and for the development of our other product candidates.

As in the past, we will continue to apply for competitive grants from the United States government under programs such as the SBIR program, among others. We believe that our eligibility to qualify as a Small Business under the SBIR guidelines will not be affected by the proposed offering; however, the eligibility could be affected by future stock issuances. To the extent that the planned studies described here can be paid for under government grants, management expects to reallocate funds budgeted for these studies to support other programs, with the primary goal of advancing compounds into the clinic.

Our expected use of net proceeds from this offering represents our current intentions based upon our present plans and business condition. As of the date of this prospectus, we cannot predict with certainty all of the particular uses for the net proceeds to be received upon the completion of this offering or the amounts that we will actually spend on the uses set forth above. The amounts and timing of our actual use of net proceeds will vary depending on numerous factors, including our ability to obtain additional financing, the relative success and cost of our research, preclinical and clinical development programs, the

amount and timing of additional revenues, if any, received from our relationships with NovaPark and Ohr Cosmetics LLC, and whether we are able to enter into future collaborations, partnerships or licensing relationships. As a result, management will have broad discretion in the application of the net proceeds, and investors will be relying on our judgment regarding the application of the net proceeds of this offering. In addition, we might decide to postpone or not pursue other clinical trials or preclinical activities if the net proceeds from this offering and the other sources of cash are less than expected.

Pending their use, we plan to invest the net proceeds from this offering in short- and intermediate-term, interest-bearing obligations, investment-grade instruments, certificates of deposit or direct or guaranteed obligations of the United States government.

We have never paid or declared any cash dividends on our common stock, and we do not anticipate paying any cash dividends on our common stock in the foreseeable future. We currently intend to retain all available funds and any future earnings to fund the development and expansion of our business. Any future determination to pay dividends will be at the discretion of our board of directors and will depend upon a number of factors, including our results of operations, financial condition, future prospects, contractual restrictions, restrictions imposed by applicable law and other factors our board of directors deems relevant.

The following table sets forth our cash and cash equivalents and capitalization as of December 31, 2013:

The pro forma and pro forma as adjusted information below is prepared for illustrative purposes only, and our capitalization following the completion of this offering will be adjusted based on the actual initial public offering price and other terms of this offering determined at pricing. You should read this table together with “Selected Financial Data,” our financial statements and the related notes appearing at the end of this prospectus and the “Management’s Discussion and Analysis of Financial Condition and Results of Operations” section of this prospectus.

The number of shares of our common stock in the table above excludes, as of December 31, 2013:

If you invest in our common stock, your ownership interest will be diluted to the extent of the difference between the initial public offering price per share and the pro forma as adjusted net tangible book value per share of our common stock immediately after this offering. Dilution results from the fact that the initial public offering price per share is substantially in excess of the book value (deficit) per share attributable to the existing stockholders for the currently outstanding stock.

As of December 31, 2013, our historical net tangible book value was $             million, or $             per share of common stock. Historical net tangible book value (deficit) per share represents the amount of our total tangible assets less total liabilities, divided by 61,200, the number of shares of common stock outstanding on December 31, 2013.

As of December 31, 2013, our pro forma net tangible book value (deficit) was $             million, or $             per share of common stock. Pro forma net tangible book value (deficit) per share represents the amount of our total tangible assets less our total liabilities, divided by the number of shares of our common stock outstanding, as of December 31, 2013, after giving effect to the recapitalization of our outstanding common stock on a 1-for-    basis.

After giving further effect to the sale of              shares of our common stock in this offering, assuming an initial public offering price of $             per share, the mid-point of the price range set forth on the cover page of this prospectus, and after deducting underwriting discounts and commissions and estimated offering expenses payable by us, our pro forma as adjusted net tangible book value as of December 31, 2013, would have been $             million, or $             per share. This amount represents an immediate increase in pro forma as adjusted net tangible book value of $             per share to our existing stockholders, and an immediate dilution in pro forma as adjusted net tangible book value of approximately $             per share to new investors purchasing shares of our common stock in this offering.

We determine dilution by subtracting the pro forma as adjusted net tangible book value per share after the offering from the amount of cash that a new investor paid for a share of common stock. The following table illustrates this dilution on a per share basis:

Each $1.00 increase (decrease) in the assumed initial public offering price of $             per share, the midpoint of the price range listed on the cover page of this prospectus, would increase (decrease) the pro forma as adjusted net tangible book value per share after this offering by approximately $            , and dilution in pro forma net tangible book value per share to new investors by approximately $            , assuming that the number of shares offered by us, as set forth on the cover page of this prospectus, remains the same and after deducting the estimated underwriting discounts and commissions and the estimated offering expenses payable by us. Each increase (decrease) of 1.0 million shares in the number of shares offered by us would increase (decrease) our pro forma as adjusted net tangible book value per share after this offering by approximately $             per share and decrease (increase) the dilution to investors participating in this offering by approximately $             per share, assuming that the assumed initial public offering price remains the same, and after deducting the estimated underwriting discounts and commissions and the estimated offering expenses payable by us.

If the underwriter exercises its option to purchase              additional shares in full in this offering, the pro forma as adjusted net tangible book value per share after giving effect to the offering would be $             per share. This represents an increase in pro forma as adjusted net tangible book value of $             per share to existing stockholders and dilution in pro forma as adjusted net tangible book value of $             per share to new investors.

The following table summarizes, on a pro forma as adjusted basis as of December 31, 2013, the total number of shares purchased from us, the total consideration paid, or to be paid, and the average price per share paid, or to be paid, by existing stockholders and by new investors in this offering at an assumed initial public offering price of $             per share, which is the midpoint of the price range listed on the cover page of this prospectus, before deducting underwriting discounts and commissions and estimated offering expenses payable by us. As the table shows, new investors purchasing shares in this offering will pay an average price per share substantially higher than our existing stockholders paid.