-----BEGIN PRIVACY-ENHANCED MESSAGE----- Proc-Type: 2001,MIC-CLEAR Originator-Name: webmaster@www.sec.gov Originator-Key-Asymmetric: MFgwCgYEVQgBAQICAf8DSgAwRwJAW2sNKK9AVtBzYZmr6aGjlWyK3XmZv3dTINen TWSM7vrzLADbmYQaionwg5sDW3P6oaM5D3tdezXMm7z1T+B+twIDAQAB MIC-Info: RSA-MD5,RSA, J25jLj83r+OjtDUPnzx/yxaJDkOcqoSO7cSXQkFLIHdIF0dKF1m/fOfd5fkDzLp0 g7+HlE5RxuuAeEQ1hdH2Ag== 0000898430-01-001140.txt : 20010410 0000898430-01-001140.hdr.sgml : 20010410 ACCESSION NUMBER: 0000898430-01-001140 CONFORMED SUBMISSION TYPE: 10-K405 PUBLIC DOCUMENT COUNT: 3 CONFORMED PERIOD OF REPORT: 20001231 FILED AS OF DATE: 20010330 FILER: COMPANY DATA: COMPANY CONFORMED NAME: HOLLIS EDEN PHARMACEUTICALS INC /DE/ CENTRAL INDEX KEY: 0000899394 STANDARD INDUSTRIAL CLASSIFICATION: 2834 IRS NUMBER: 133697002 STATE OF INCORPORATION: DE FISCAL YEAR END: 1231 FILING VALUES: FORM TYPE: 10-K405 SEC ACT: SEC FILE NUMBER: 000-24672 FILM NUMBER: 1588434 BUSINESS ADDRESS: STREET 1: 9333 GENESEE AVENUE STREET 2: SUITE 200 CITY: SAN DIEGO STATE: CA ZIP: 92121 BUSINESS PHONE: 8585879333 MAIL ADDRESS: STREET 1: 9333 GENESEE AVENUE STREET 2: SUITE 200 CITY: SAN DIEGO STATE: CA ZIP: 92121 FORMER COMPANY: FORMER CONFORMED NAME: INITIAL ACQUISITION CORP DATE OF NAME CHANGE: 19930329 10-K405 1 0001.txt FORM 10-K - - ------------------------------------------------------------------------------- - - ------------------------------------------------------------------------------- SECURITIES AND EXCHANGE COMMISSION WASHINGTON, D.C. 20549 ---------------- FORM 10-K ANNUAL REPORT PURSUANT TO SECTION 13 OR 15(d) OF THE SECURITIES EXCHANGE ACT OF 1934 For the fiscal year ended December 31, 2000 Commission File Number 33-60134 HOLLIS-EDEN PHARMACEUTICALS, INC. (Exact name of Registrant as specified in its charter) Delaware 13-3697002 -------- ---------- (State or other jurisdiction (I.R.S. Employer of incorporation or organization) Identification No.) 9333 Genesee Avenue, Suite 200 San Diego, CA 92121 ------------- ----- (Address of principal executive offices) (Zip Code)
Registrant's telephone number, including area code: (858) 587-9333 Securities registered pursuant to Section 12(b) of the Act: None Securities registered pursuant to Section 12(g) of the Act: Common stock, $.01 par value per share Indicate by check mark whether the Registrant (1) has filed all reports required to be filed by Section 13 or 15(d) of the Securities Act of 1934 during the preceding months (or for such shorter period that the Registrant was required to file such reports), and (2) has been subject to such filing requirement for the past 90 days. YES [X] NO [_] Indicate by check mark if disclosure of delinquent filers pursuant to Item 405 of Regulation S-K is not contained herein, and will not be contained, to the best of the Registrant's knowledge, in definitive proxy or information statements incorporated by reference in Part III of this Form 10-K or any amendment to this Form 10-K. [X] The aggregate market value of the voting stock held by nonaffiliates of the Registrant as of March 15, 2001 totaled approximately $32,990,916 based on the closing stock price as reported by the Nasdaq National Market. As of March 15, 2001, there were 11,605,803 shares of the Registrant's Common Stock, $.01 par value per share, outstanding. DOCUMENTS INCORPORATED BY REFERENCE Certain portions of Registrant's Annual Report to Stockholders for the fiscal year ended December 31, 2000, are incorporated by reference into Part II of this report. Registrant's definitive proxy statement to be filed with the Securities and Exchange Commission, pursuant to regulation 14A in connection with the 2001 Annual Meeting of Stockholders to be held during June 2001, is incorporated by reference into Part III of this Report. - - ------------------------------------------------------------------------------- - - ------------------------------------------------------------------------------- HOLLIS-EDEN PHARMACEUTICALS, INC. Form 10-K For the Fiscal Year Ended December 31, 2000 INDEX
Page ---- PART I Item 1 Business.................................................... 3 Item 2 Properties.................................................. 21 Item 3 Legal Proceedings........................................... 21 Item 4 Submission of Matters to a Vote of Security Holders......... 22 PART II Item 5 Market For Registrant's Common Stock And Related Stockholder Matters..................................................... 22 Item 6 Selected Financial Data..................................... 23 Item 7 Management's Discussion and Analysis of Results of Operations and Financial Condition.......................... 23 Item 7A Quantitative and Qualitative Disclosures About Market Risk.. 25 Item 8 Financial Statements and Supplementary Data................. 25 Item 9 Changes in and Disagreements with Accountants on Accounting and Financial Disclosures................................... 25 PART III Item 10 Directors and Executive Officers of the Registrant.......... 26 Item 11 Executive Compensation...................................... 26 Security Ownership of Certain Beneficial Owners and Item 12 Management.................................................. 26 Item 13 Certain Relationships and Related Transactions.............. 26 PART IV Item 14 Exhibits, Financial Statements, Schedules and Reports on Form 8-K.................................................... 27 Signatures.................................................. 28
2 This Annual Report on Form 10-K contains certain forward-looking statements that involve risks and uncertainties. The actual future results for Hollis- Eden Pharmaceuticals, Inc. may differ materially from those discussed here. Additional information concerning factors that could cause or contribute to such differences can be found in this Annual Report on Form 10-K in Part I, Item 1 under the caption "Risk Factors," Part II, Item 7 entitled "Management's Discussion and Analysis of Results of Operations and Financial Condition" and elsewhere throughout this Annual Report. PART I Item 1. Business General Hollis-Eden Pharmaceuticals, Inc., a development-stage pharmaceutical company, is engaged in the discovery, development and commercialization of products for the treatment of infectious diseases and immune system disorders, including HIV/AIDS, hepatitis B and C and malaria. We are focusing our initial development efforts on a potent series of immune regulating hormones and hormone analogs. Our lead compound in this series, HE2000, is currently in Phase II clinical studies in HIV. HE2000 appears from early clinical studies to help reestablish immunological balance in situations such as HIV where the immune system is dysregulated. In the setting of HIV we believe that, by reestablishing this balance, the immune system may be able to better control virus levels and potentially delay or prevent the progression to AIDS. In addition, based on the mechanism of action, we believe this compound will have an attractive safety profile and will avoid issues of resistance that plague many existing antiviral drugs. The ability to restore immune system balance has the potential to have broad applicability to a wide variety of infectious diseases and oncology- related applications as well as a number of inflammatory conditions. To more fully exploit this commercial opportunity we are conducting an aggressive research program and licensing effort designed to expand both the number of compounds in development from this class and the breadth of potential therapeutic applications. Several compounds resulting from these activities have shown promising activity in preclinical models. We recently filed an investigational new drug application (an "IND") with the U.S. FDA to commence clinical trials with one of these promising compounds, HE2200. In addition, through our relationship with Aeson Theraputics, Inc. ("Aeson"), we have a right to acquire significant additional intellectual property in this field, including the rights to a compound in this class that is in Phase II clinical trials for the treatment of cardiovascular disease and actinic keratosis, a precursor to squamous cell cancer. We are pursuing a partially integrated approach to building our business. As such, we intend to utilize third parties for many of our activities such as clinical development and manufacturing. We believe by being involved in the design and supervision of these activities, but not the day-to-day execution, we can preserve our flexibility and limit our expenditures during the development phase. If we are able to successfully develop HE2000 or other pharmaceutical products, we anticipate marketing them directly in the U.S. and potentially elsewhere. For certain therapeutic indications or geographic regions, we anticipate establishing strategic collaborations to commercialize these opportunities. We have not yet generated any operating revenues. We have experienced significant operating losses due to substantial expenses incurred to acquire and fund development of our drug candidates and, as of December 31, 2000, had an accumulated deficit of approximately $48 million. We cannot guarantee that any of our drug candidates will be approved for commercial sale or that any of the foregoing proposed arrangements will be implemented or prove to be successful. 3 We have not been profitable since our inception and we expect to incur substantial additional operating losses for at least the next several years as we increase expenditures on research and development and allocate significant and increasing resources to our clinical testing and other activities. In addition, during the next few years, we may have to meet the substantial new challenge of developing the capability to market products. Accordingly, our activities to date are not as broad in depth or scope as the activities we must undertake in the future, and our historical operations and financial information are not indicative of future operating or financial condition or our ability to operate profitably as a commercial enterprise when and if we succeed in bringing any drug candidate to market. Technology Overview Our initial technology development efforts are focused on a series of potent hormones and hormone analogs that we believe are key components of the body's natural regulatory system. The first application we are pursuing for this class of compounds is a hormonal replacement therapy intended to reestablish balance to the immune system in situations of dysregulation. In the immune system, there are two types of immunity, cell-mediated and humoral, that exist in a balance. Cell-mediated immunity is useful against intracellular pathogens like viruses, certain parasites and also against some tumor cells. Humoral immunity includes antibody responses to circulating pathogens such as bacteria. As a result, cell-mediated immunity is largely ineffective against bacteria and humoral immunity is similarly ineffective against viruses. Normally, immune system homeostasis is maintained by a complex interplay of cytokines. Cytokines are protein messengers that enable cells of the immune system to communicate with one another. Certain cytokines such as interferon (IFN) gamma are termed Th1 cytokines, as they lead to the production of Th1 cells that fight viruses through cell-mediated immunity. Other cytokines such as interleukin 10 (IL-10) are classified as Th2 cytokines because they lead to the production of Th2 cells that fight bacteria and other such pathogens as part of humoral immunity. Unfortunately, a wide variety of viruses including HIV and hepatitis B and C, certain parasites such as malaria, and a number of different tumor cells have evolved ways of evading destruction by the immune system by causing the body to overproduce Th2 cytokines and underproduce Th1 cytokines. This in turn leads to a corresponding overproduction of cells unable to fight these pathogens and an underproduction of cells that can. In the setting of HIV, this generally results in an immune system that progressively losses its ability to combat infections. Hollis-Eden's technology approach is based on the observation that this complicated balance of cytokines is regulated by competing levels of certain adrenal hormones. In young, healthy adults, the balance between corticosteroids such as cortisol, which have immunosuppressive properties, and other adrenal hormones is a key determinant in whether appropriate levels of cytokines are produced to properly regulate immune responses. As we age, and under conditions of stress and chronic infections, levels of these hormones that counteract the immunosuppressive effect of corticosteroids fall significantly, leading to a decline in the ability to fight off infections that would otherwise be contained by a well functioning immune system. As described above, certain pathogens have found ways to accelerate this process through natural selection. For example, in HIV, most patients' cortisol levels rise (and counter-regulatory adrenal hormones fall) as the disease progresses from HIV to AIDS. This leads to a corresponding increase in Th2 cytokines such as IL-10 relative to Th1 cytokines such as IFN gamma. As this situation continues, the immune system is dominated by Th2 cells unable to fight viral and other infections rather than the necessary cell-mediated Th1 cells. In this state of immune system dysregulation, the patient becomes highly susceptible to infection. Certain HIV patients, however, maintain their ability to continue to produce high levels of Th1 cytokines and, in this small percentage of patients, HIV appears to take much longer to progress to AIDS. These patients 4 are termed "HIV long-term non-progressors." Similarly, in hepatitis C, a small percentage of patients are able to mount a strong Th1 response and in these patients the immune system is able to successfully clear the virus. These observations have led to the belief that if patients can be brought from a predominant Th2 immune status back towards a Th1 dominant condition through drug therapy, the immune system may be able to contain or eliminate a number of such infectious pathogens that are plaguing millions of people around the world. This Th1/Th2 imbalance is seen not just with infectious disease, but also in cancer, autoimmune and inflammatory diseases. Thus, a drug that effectively corrects immune dysregulation could have the potential to address a wide variety of human ailments. Our approach is designed to interact at what is believed to be the trigger point of this dysregulation, the hormonal balance between corticosteroids and other adrenal hormones, offering a hormone replacement therapy that potentially will lead to stimulation of the immune system in conditions of immunosuppression. We are employing the latest tools of the genomics revolution to further our expertise in adrenal hormone biochemistry, signal transduction, receptor biology and gene transcription for this important class of compounds. We are seeking to identify and develop compounds that are highly potent and that avoid androgenic and other side effects. Our lead compound in this series is HE2000, which is currently being explored in clinical trials for HIV/AIDS. Clinical trials with HE2000 in malaria, hepatitis B and C are in the process of being initialized. In addition, we have filed an IND with the FDA to begin clinical trials with HE2200, another immune regulating hormone drug candidate. This compound also has the potential to be useful in a number of conditions associated with immune dysregulation. Through our relationship with Aeson we also have access to an additional compound in this class, which is currently in Phase II clinical trials for the treatment of cardiovascular disease and actinic keratosis. HE2000 in HIV Significant strides have been made in recent years in treating HIV-infected individuals in the developed world. Through the use of a "cocktail" of potent new antiviral drugs, including protease inhibitors and reverse transcriptase inhibitors, death rates from AIDS have been reduced significantly in these countries. These expensive new therapies, however, are not ideal for a number of reasons. Despite being on successful therapy for several years, patients to date have been unable to completely eradicate the virus, which bounces back aggressively shortly after cessation of therapy. HIV mutates rapidly in the face of antiviral compounds that are designed to attack the virus directly, leading to the development of resistance. Drug resistance is a major concern of physicians, as a large portion of patients are already resistant to at least one drug in their drug cocktail and experts believe that drug resistance will increase in the future. In addition, the dosing regimen for HIV drug cocktail therapy is very complicated, with a large number of pills required to be taken daily according to a strict schedule. Failure to adhere to this regimen can lead to increased resistance. Further, side effects of these therapies can be significant, leading many of these patients to be unable or unwilling to tolerate the drug regimen. As a result of these side effects and resistance issues, the National Institutes of Health have recently altered recommendations for when to start patients on the antiviral cocktail, recommending that treatment be delayed until patients have significantly progressed towards AIDS. In the developing world, the antiviral cocktail has to date been largely impractical as a result of cost, lack of required training and infrastructure necessary to safely and effectively administer these agents, and the difficulty in complying with the dosing regimen. While significant attention has been focused on the need to treat the millions suffering from the disease in these nations, an approach which is safe, inexpensive and practical to administer has yet to be introduced. We believe HE2000 has the potential to play an important role in treating HIV/AIDS in both the developed and developing world. In the developed world, we believe that if we can demonstrate clinically that HE2000 5 restores or improves immune system activity, there may be a number of significant opportunities for use of the compound. It may be useful for long- term control of viral replication as well as delaying or preventing the progression to AIDS and preventing or clearing opportunistic infections. At a minimum, this could prove very useful in treating patients who cannot tolerate other therapies and in salvage patients for whom other drug therapies have failed and whose immune systems have generally been ravaged by HIV. In the developing world, HE2000 may be particularly attractive because we believe the drug will be administered on an intermittent (rather than daily) basis, and will have a lower manufacturing cost than existing therapies. Given its probable endocrine mechanism of action, it should also avoid issues of resistance. We began testing HE2000 in Phase I/II clinical trials in HIV/AIDS patients in the U.S. and South Africa in 1999. Although primarily designed to assess safety, these trials are also following a wide variety of immune markers that will help determine whether or not the Th1/Th2 balance is being altered in HIV-infected patients by HE2000 administration, and in turn, what effect this may have on immune function. The U.S. trials involve a single course of HE2000 injections to salvage patients. The Phase I/II clinical trial in South Africa is a dose escalation study evaluating the effect of HE2000 in three dosing groups. Patients initially receive a single intramuscular injection followed one to two weeks later by a daily injection for five consecutive days. After a six-week observation period, patients demonstrating benefit are allowed to receive additional courses of therapy (five consecutive daily injections followed by a six-week observation period). The study is now fully enrolled and interim data were recently presented at a medical meeting. Reported results were through three treatment courses over a five-month period. At the discretion of the investigator, patients may continue receiving treatment beyond this period and some patients have now been on study for over 18 months. The primary endpoint of the study is safety, and to date HE2000 has been generally well tolerated, with injection site irritation in three patients being the only drug-related serious adverse event reported in this study. While the studies are focused on collecting safety data, we have also observed significant increases relative to baseline in a wide variety of immune cell subsets associated with cell-mediated immunity during the study in South Africa. The data relating to this study presented at the medical meeting referenced above highlighted a number of these cell subsets that were statistically significantly elevated relative to baseline in an area-under- the-curve (AUC) analysis for all patients for the five-month treatment period. Included were statistically significant increases in total dendritic cells, CD11c+ dendritic cells, CD123+ dendritic cells and activated cytotoxic T- cells. These increases appeared to be long lasting despite the fact that HE2000 was only administered in intermittent treatment courses. Dendritic cells are specialized antigen processing and presenting cells that are critical in regulating immune responses. The CD11c+ dendritic cell subset that was increased in this study is a primary driver in initiating adaptive cell-mediated immunity. The adaptive portion of cell-mediated immunity is important for controlling HIV replication and combating opportunistic infections to which the immune system has previously been exposed. Medical literature indicates that the CD11c+ dendritic cell subset is dramatically depleted in HIV-infected patients and that this dysregulation persists even in patients on successful Highly Active Antiretroviral Therapy (HAART). It also has been reported in the medical literature that CD123+ dendritic cells can drive cell-mediated immunity. These cells are now believed to be a key source of stimulation of the innate portion of the immune system. This part of the immune system is particularly effective against pathogens which are newly exposed to the immune system, including a variety of opportunistic infections seen in HIV/AIDS patients. In 1999, the CD123+ cell was identified as the immune system's primary source of the cytokine interferon alpha. It has also been reported in the literature that those patients with high levels of interferon alpha tend to remain clinically stable and avoid opportunistic infections irrespective of levels of the traditional markers of viral load and CD4. 6 Activated CD8 T-cells are part of the adaptive portion of Thl immunity and are primed to recognize and destroy cells infected with a particular virus or opportunistic infection. While not an antiviral, patients in South Africa receiving HE2000 as an intermittent monotherapy overall did not experience a progression in viral load during the five months on study, and a number of these patients experienced a significant transient drop in viral load that in some cases exceeded 1 log. Further improvements in viral load for a greater duration may be obtainable with improved formulation, dosing schedule and route of administration. Additional clinical studies have now been initiated in South Africa to test these possibilities. HE2000 also had a significant effect on the hematopoetic system in the Phase I/II study in South Africa. Administration of HE2000 led to increases (versus baseline) in a number of cell types that were quite pronounced immediately after dosing. These increases were durable enough to be statistically significant in an area-under-the-curve analysis during the entire five-month treatment period. Included in these cell types are neutrophils, basophils, monocytes and platelets. This finding has potential applications for cancer therapy and is currently being explored more fully in preclinical studies. We are currently optimizing the dosing regimen of HE2000 and have initiated a Phase II clinical trial with the compound in South African AIDS patients who are experiencing, or are at a high risk for opportunistic infections. We are also considering additional clinical trials in which HE2000 would be used in combination with existing antiviral drug cocktail therapy. Significant additional clinical data will need to be generated demonstrating the safety and efficacy of HE2000 before the compound can be approved for marketing. We cannot be certain that we will have sufficient funds to complete this development, or that the results of these clinical activities will be successful and support the approval of any drug candidate. HE2000 in Other Indications The potential ability of HE2000 to shift patients from a Th2 immune status back to a Th1 status could have applications well beyond HIV/AIDS. As mentioned previously, in hepatitis C, a small percentage of patients are able to clear the virus by mounting a strong cell-mediated (Th1) response. Given the early clinical data with HE2000, which demonstrates a strong Th1 response in HIV patients, we are exploring the initiation of clinical studies for the treatment of hepatitis C as well as hepatitis B. Existing therapies for hepatitis have proven to be effective in only a portion of the patients treated. In addition, side effects of these existing therapies can be significant and the regimen is very expensive. As with HIV, resistance is a serious problem in treating the disease. Also as with HIV, cost and other aspects of existing therapies make them largely impractical in the developing world. Similarly, malarial parasites have found ways to subvert the immune system by causing a shift from Th1 to Th2. Historically, therapies with quinalone- based drugs such as chloroquine have been used to treat this condition. Recently, however, strains have developed that are resistant to chloroquine and other quinalones, making these drugs ineffective in many parts of the world. We have shown in both in vitro and in vivo preclinical studies that HE2000 is effective in treating both chloroquine sensitive and chloroquine resistant strains of malaria. We are working with the U.S. Navy to further test HE2000 preclinically in this indication and are also in the process of initiating clinical trials in this area. Other Immune Regulating Hormones in Development To expand the depth and breadth of our development pipeline, we have entered into collaborative agreements with a number of leading researchers in this field to develop additional compounds that may be more 7 potent and/or target conditions outside of infectious disease. In addition, we have licensed a large number of patents and patent applications filed on behalf of these researchers. A number of the compounds covered by these patents have demonstrated potent activity in preclinical testing in a variety of indications including applications in oncology, inflammation and certain central nervous system and metabolic disorders. In March 2001, we announced we had submitted an IND with the FDA to begin human clinical trials with HE2200, another immune regulating hormone drug candidate. HE2200 has been shown to provide significant benefit in a number of animal models of immune dysregulation. The compound was licensed to Hollis- Eden from Roger Loria Ph.D., a leading researcher in the field of immune regulating hormones and a Professor of Microbiology and Immunology at Virginia Commonwealth University. The IND seeks clearance to test HE2200 in a Phase I clinical trial in healthy adults and healthy elderly volunteers, with the primary endpoint of the trial being safety and tolerance of two dosage levels of HE2200. Other objectives of the trial will be to evaluate changes in a number of key immune markers and pharmacokinetic data in both groups of volunteers. The Phase I study is randomized, double blinded, and placebo-controlled. If results of the Phase I study are successful, we expect to commence Phase II studies with the compound in several conditions of immune dysregulation, including reversing immune deficiencies seen in the elderly. Preclinical studies with HE2200 and initial clinical results with HE2000, our lead immune regulating hormone in development, indicate that this class of compounds may improve defects in cell-mediated (Th1) immunity and may also improve hematopoiesis (restoring neutrophils and platelets). Deficiency of cell-mediated immunity has been strongly correlated with an immune system's inability to effectively fight a number of infectious diseases and cancer types. The loss of ability to mount a strong cell-mediated immune response seen in the elderly is believed to be a primary reason patients in this age group have difficulty recovering from infectious diseases such as the flu and pneumonia and also why vaccines in this population tend to be less effective. Laboratory tests with HE2200 have shown that the compound can reverse the loss of cell-mediated immunity seen in aged animals and that correcting this dysregulation with HE2200 treatment allows these animals to respond better to vaccination. A recently published study with the compound has also shown dramatic survival improvements in HE2200-treated animals versus controls in a model of radiation-induced immune suppression. The authors of the study concluded that HE2200 was providing this benefit by accelerating hematopoietic recovery. As discussed above, our lead immune regulating hormone, HE2000, has demonstrated an ability to improve hematopoiesis in initial clinical studies in HIV patients. This finding, combined with the potential ability to improve cell-mediated immunity, also makes HE2200 an attractive potential candidate for use in improving immunity and hematopoiesis in cancer patients. HE2200 may also provide benefit in a number of autoimmune conditions. Studies with the compound in a preclinical model of ulcerative colitis showed that the compound compared favorably with sulfasalazine, a current standard of care in the treatment of the disease. If further preclinical work in autoimmune models is successful, this area may also be explored in clinical studies with the compound. Through our collaboration with Humanetics, Inc., we also have human pharmaceuticals rights to an additional series of compounds in this series that are the subject of patents filed by Dr. Henry Lardy, a professor at the University of Wisconsin. Several of these compounds are being screened in preclinical models, and if these results are successful, these compounds could become candidates for clinical trials. Relationship with Aeson Therapeutics, Inc. During 2000 we obtained an exclusive worldwide sublicense to three additional issued patents in the area of adrenal hormones and hormone analogs from Aeson Therapeutics, Inc. In addition, we acquired a 21% equity stake in Aeson, which is developing molecules that are analogs with similar biological properties to HE2000. Aeson's lead compound, fluasterone (HE2500), is in Phase II clinical studies for the treatment of cardiovascular disease and actinic keratosis, a precursor to squamous cell cancer, as well as in preclinical studies for other indications. 8 We exchanged $2 million in cash and 208,681 shares of Hollis-Eden common stock for our equity interest in Aeson. The cash portion of the investment is being used by Aeson to fund specific studies with fluasterone as well as other compounds in its pipeline. As part of the transaction, Aeson and its shareholders have granted us an exclusive option to acquire the remainder of Aeson at a pre-determined price at any time through April 11, 2003. Aeson is a privately held company that was formed to commercialize the discoveries of Dr. Arthur Schwarz, a professor at Temple University and a world leader in the field of adrenal hormones. Dr. Schwarz has identified and patented numerous compounds in this series and has shown preclinical activity with these compounds in a broad array of infectious disease, autoimmune and oncology models. Phase I human clinical studies indicate fluasterone is generally well tolerated. Aeson is conducting a pilot Phase II clinical study for the treatment of actinic keratosis, a dermatologic condition, using fluasterone in a topical form. Aeson has also inititated a Phase II study using an oral form of fluasterone for the treatment of cardiovascular patients with a particular lipid profile. Aeson is also conducting preclinical studies using fluasterone in a number of other potential indications, including a collaboration with the National Cancer Institute to explore the use of fluasterone in cancer. Market Opportunities The potential market opportunities for the compounds we are developing may be quite significant. As an example, approximately 1 billion people are estimated to be infected with HIV, malaria or hepatitis B or C, the first four indications we are targeting for HE2000, our lead drug candidate. Despite considerable progress with antiviral drug cocktail therapy, today AIDS is the number one killer of Americans between the ages of 25 and 44. It is estimated by the Centers for Disease Control ("CDC") that approximately 1.1 million Americans are infected with HIV. Globally, the World Health Organization ("WHO") and the Joint United Nations Programme on HIV/AIDS reported, as of December 2000, approximately 36.1 million adults and children are living with HIV/AIDS, an 8% increase since 1998 and a 50% increase from 1991. It is also estimated that there were 5.3 million newly infected people and 3 million deaths related to HIV/AIDS in 2000. In October 2000, WHO reported that 3% of the world's populations, an estimated 170 million people, are chronic carriers of hepatitis C, including an estimated 4 million in the U.S. Of those afflicted with hepatitis C, 10% to 20% are at risk of developing cirrhosis of the liver and 1% to 5% may develop liver cancer. WHO also reported during October 2000 that more than 350 million people have chronic hepatitis B infection and more than 1 million die from the disease each year. The CDC estimates that more than 1 million people in the United States are chronically infected with the disease. As with hepatitis C, hepatitis B can lead to liver abnormalities, and the disease is believed to be the leading cause of liver cancer. Market research also indicates that 300-500 million people per year suffer from malaria. This parasite is responsible for more than 1 million deaths annually, most of them children. Most cases of malaria occur in the developing world but, as a result of increased global travel and other factors, the incidence of malaria in the developed world is increasing. Finding new approaches to the treatment of malaria has become a major priority of the U.S. military. The market for HE2200 may also be quite significant, including the potential for correcting immune dysregulation in the elderly. This is a large and rapidly growing segment of the population. Our immune regulating hormones have a number of attributes that make them potentially useful globally. Included in these attributes are the potential broad-spectrum activity, affordable cost, the attractive safety profile to date, the low likelihood of resistance and the relative ease of manufacture and dosing. Increasing focus on the 9 crisis these diseases have created in the developing world has led to a number of recent initiatives designed to provide funding for effective approaches to these diseases. If we are able to receive support from these initiatives, marketing HE2000 and our other compounds in developing countries could become more commercially feasible. Competition Given the large market opportunities we are pursuing, most major pharmaceutical companies and a number of biotechnology companies have programs directed toward finding drugs to treat indications we are exploring. Most of these approaches in infectious disease are targeted at creating new antiviral compounds rather than drugs that upregulate the immune system. As such, they will be expected to have different profiles than our compounds and may be complementary to our efforts. There can be no assurance, however, that other companies will not develop drugs that make our development efforts obsolete. Many of these competitors have substantially greater human and financial resources than we do and, even if we are successful at developing our compounds, others with greater resources may be able to market their products more successfully. Government Regulation General The manufacturing and marketing of Hollis-Eden's proposed products and its research and development activities are and will continue to be subject to regulation by federal, state and local governmental authorities in the United States and other countries. In the United States, pharmaceuticals are subject to rigorous regulation by the FDA, which reviews and approves the marketing of drugs. The Federal Food, Drug and Cosmetic Act, the regulations promulgated thereunder, and other federal and state statutes and regulations govern, among other things, the testing, manufacturing, labeling, storage, record keeping, advertising and promotion of our potential products. Approval Process The process of obtaining FDA approval for a new drug may take many years and generally involves the expenditure of substantial resources. The steps required before a new drug can be produced and marketed for human use include clinical trials and the approval of a New Drug Application. Preclinical Testing. The promising compound is subjected to extensive laboratory and animal testing to determine if the compound is biologically active and safe. Investigational New Drug (IND). Before human tests can start, the drug sponsor must file an IND application with the FDA, showing how the drug is made and the results of animal testing. IND status allows initiation of clinical investigation within 30 days of filing if the FDA does not respond with questions during the 30-day period. Human Testing (Clinical). The human clinical testing program usually involves three phases which generally are conducted sequentially, but which, particularly in the case of anti-cancer and other life saving drugs, may overlap or be combined. Clinical trials are conducted in accordance with protocols that detail the objectives of the study, the parameters to be used to monitor safety and the efficacy criteria to be evaluated. Each protocol is submitted to the FDA as part of the IND filing. Each clinical study is conducted under the auspices of an independent Institutional Review Board ("IRB") for each institution at which the study will be conducted. The IRB will consider, among other things, all existing pharmacology and toxicology information on the product, ethical factors, the risk to human subjects and the potential benefits of therapy relative to risk. In Phase I clinical trials, studies usually are conducted on healthy volunteers but, in the case of certain terminal illnesses such as AIDS, are conducted on patients with disease that usually has failed to respond to 10 other treatment to determine the maximum tolerated dose, side effects and pharmacokinetics of a product. Phase II studies are conducted on a small number of patients having a specific disease to determine initial efficacy in humans for that specific disease, the most effective doses and schedules of administration, and possible adverse effects and safety risks. Phase II/III differs from Phase II in that the trials involved may include more patients and, at the sole discretion of the FDA, be considered the pivotal trial or trials for FDA approval. Phase III normally involves the pivotal trials of a drug, consisting of wide-scale studies on patients with the same disease, in order to evaluate the overall benefits and risks of the drug for the treated disease compared with other available therapies. The FDA continually reviews the clinical trial plans and results and may suggest design changes or may discontinue the trials at any time if significant safety or other issues arise. New Drug Application (NDA). Upon successful completion of Phase III, the drug sponsor files an NDA for approval containing all information that has been gathered. The NDA must include the chemical composition of the drug, scientific rationale, purpose, animal and laboratory studies, results of human tests, formation and production details, and proposed labeling. Post Approval. If an NDA is approved, the drug sponsor is required to submit reports periodically to the FDA containing adverse reactions, production, quality control and distribution records. The FDA may also require post-marketing testing to support the conclusion of efficacy and safety of the product, which can involve significant expense. After FDA approval is obtained for initial indications, further clinical trials may be necessary to gain approval for the use of the product for additional indications. The testing and approval process is likely to require substantial time and effort, and there can be no assurance that any FDA approval will be granted on a timely basis, if at all. The approval process is affected by a number of factors, primarily the side effects of the drug (safety) and its therapeutic benefits (efficacy). Additional preclinical or clinical trials may be required during the FDA review period and may delay marketing approval. The FDA may also deny an NDA if applicable regulatory criteria are not met. Outside the United States, we will be subject to foreign regulatory requirements governing human clinical trials and marketing approval for its products. The requirements governing the conduct of clinical trials, product licensing, pricing and reimbursements vary widely from country to country. Manufacturing We do not have, and do not intend to establish, manufacturing facilities to produce our product candidates or any future products. We plan to control our capital expenditures by using contract manufacturers to make our products. We believe that there are a sufficient number of high quality FDA approved contract manufacturers available, and we have had discussions and in some cases established relationships to fulfill our near-term production needs for both clinical and commercial use. The manufacture of our product candidates or any future products, whether done by outside contractors (as planned) or in-house by ourselves, will be subject to rigorous regulations, including the need to comply with the FDA's current Good Manufacturing Practice standards. As part of obtaining FDA approval for each product, each of the manufacturing facilities must be inspected, approved by and registered with the FDA. In addition to obtaining FDA approval of the prospective manufacturer's quality control and manufacturing procedures, domestic and foreign manufacturing facilities are subject to periodic inspection by the FDA and/or foreign regulatory authorities. Patents We are engaged in an aggressive program to expand our intellectual property portfolio. As a result, as of the date of this Annual Report, we own or have obtained a license to approximately 30 issued U.S. patents, 37 issued foreign patents, 30 pending U.S patent applications and more than 80 pending foreign patent applications. In addition, based on the preclinical and clinical data that we are generating, a significant number of U.S. and foreign patent applications are in the process of being filed. 11 We consider the protection of our technology, whether owned or licensed, to the exclusion of use by others, to be vital to its business. While we intend to focus primarily on patented or patentable technology, we may also rely on trade secrets, unpatented property, know-how, regulatory exclusivity, patent extensions and continuing technological innovation to develop our competitive position. In the United States and certain foreign countries, the exclusivity period provided by patents covering pharmaceutical products may be extended by a portion of the time required to obtain regulatory approval for a product. In certain countries, pharmaceuticals are not patentable or only recently have become patentable, and enforcement of intellectual property rights in many countries has been limited or non-existent. Future enforcement of patents and proprietary rights in many countries can be expected to be problematic or unpredictable. We cannot guarantee that any patents issued or licensed to us will provide us with competitive advantages or will not be challenged by others. Furthermore, we cannot be certain that others will not independently develop similar products or will not design around patents issued or licensed to us. Patent applications in the United States are maintained in secrecy until patents issue. Publication of discoveries in the scientific or patent literature, if made, tends to lag behind actual discoveries by several months. Consequently, we cannot be certain that a licensor of its intellectual property was the first to invent certain technology or compounds covered by pending patent applications or issued patents or that it was the first to file patent applications for such inventions. In addition, the patent positions of biotechnology companies, including our own, are generally uncertain, partly because they involve complex legal and factual questions. In addition to the considerations discussed above, companies that obtain patents claiming products, uses or processes that are necessary for, or useful to, the development of our product candidates or future products could bring legal actions against us claiming infringement. Patent litigation is typically costly and time consuming, and if such an action were brought against us, it could result in significant cost and diversion of our time. We may be required to obtain licenses to other patents or proprietary rights, and we cannot guarantee that licenses would be made available on terms acceptable to us. If we do not obtain such licenses, we could encounter delays in product market introductions while we attempt to license technology designed around such patents or could find that the development, manufacture or sale of products requiring such licenses is foreclosed. Further, we cannot guarantee that patents that are issued will not be challenged, invalidated or infringed upon or designed around by others, or that the claims contained in such patents will not infringe the patent claims of others, or provide us with significant protection against competitive products, or otherwise be commercially valuable. We may need to acquire licenses under patents belonging to others for technology potentially useful or necessary to us. If any such licenses are required, we cannot be certain that they will be available on terms acceptable to us, if at all. To the extent that we are unable to obtain patent protection for our products or technology, our business may be materially adversely affected by competitors who develop substantially equivalent technology. Technology Agreements During January 2000, we entered into two new technology agreements with Patrick T. Prendergast, Colthurst Ltd. and Edenland, Inc. The first agreement, the Technology Assignment Agreement, replaced the Colthurst License Agreement dated May 18, 1994 among Hollis-Eden, Mr. Prendergast and Colthurst. This agreement assigned to us ownership of all patents, patent applications and current or future improvements of the technology under the Colthurst License Agreement, including HE2000, our lead clinical compound. The annual license fee of $500,000 and the royalty obligations under the Colthurst License Agreement were eliminated. In consideration for the foregoing, we agreed to issue to Colthurst Ltd. 660,000 shares of Common Stock and a warrant to purchase an aggregate of 400,000 shares of Common Stock at $25 per share. The agreement provided that only 132,000 of such shares of Common Stock were to be issued in 2000, with the remaining 528,000 shares to be issued over the next four years conditioned on continued compliance with the agreement and, in particular, satisfaction of the Conditions (as defined below). In addition, the agreements provided that all of the shares under 12 the warrant were to vest over the next four years conditioned on continued compliance with the agreement and satisfaction of the Conditions. As stated above, the issuance of the additional shares of Common Stock and the vesting of the warrant is dependent upon the satisfaction of certain conditions (the "Conditions"), including (i) support of the our actions by Mr. Prendergast and Colthurst, by voting their shares of our stock in favor of management and (ii) Mr. Prendergast and his affiliated companies not conducting research and development activities relating to the transferred technology. Because all of the Conditions have not been satisfied, we believe that we have no obligation to issue to Colthurst any additional shares and that the warrant will not vest as to any shares of Common Stock. Due to this fact, and after conducting further accounting analysis, we have recorded a research and development charge of $1.9 million representing the fair value of the 132,000 shares issued under the agreement. While we are confident in our analysis, if any dispute should arise in this matter, we cannot guarantee that, as a result of such dispute, additional equity will not be issued or that an additional accounting charge will not be made. The second agreement, the Sponsored Research and License Agreement, replaced both the Edenland License Agreement and the Research, Development and Option Agreement, each dated August 25, 1994, among Hollis-Eden, Mr. Prendergast and Edenland. Pursuant to the Sponsored Research and License Agreement, Edenland exclusively licensed to us a number of compounds, together with all related patents and patent applications, and we agreed to fund additional preclinical research projects conducted by Edenland. We also have exclusive license rights to all results of such research and will have royalty obligations to Edenland on sales of new products, if any, resulting from such research. We recently also entered into license agreements with Dr. Roger Loria, Dr. Henry Lardy and Humanetics Corporation, and made an equity investment in Aeson Therapeutics, Inc (described above). Through these relationships we have licensed a series of adrenal hormones and hormone analogs as well as related patents and patent applications in the areas of infectious diseases, oncology, radiation therapy, central nervous system disorders, metabolic conditions and inflammation related areas. Employees As of March 15, 2001, we had 35 full-time employees. We believe that our relations with our employees are good. Executive Officers and Senior Management Our executive officers and senior management and their ages as of March 15, 2001 are as follows:
Name Age Position - - ---- --- -------- Richard B. Hollis....... 48 Chairman of the Board, President and Chief Executive Officer Daniel D. Burgess....... 39 Chief Operating Officer and Chief Financial Officer James M. Frincke, Ph.D. ................. 50 Executive Vice President, Research and Development Eric J. Loumeau......... 38 Vice President, Corporate General Counsel Robert L. Marsella...... 48 Vice President, Business Development and Marketing Thomas C. Merigan, Jr., M.D. .................. 67 Scientific Advisor and Director Chris Reading, Ph.D. ... 53 Vice President, Scientific Development Dwight Stickney, M.D. .. 58 Medical Director, Oncology Robert W. Weber......... 50 Chief Accounting Officer and Vice President - Controller
Richard B. Hollis founded Hollis-Eden in August 1994. Mr. Hollis currently serves as Chairman, President and Chief Executive Officer. Mr. Hollis has over 25 years experience in the health care industry in a variety of senior management positions. Prior to founding Hollis-Eden, Mr. Hollis served as Chief Operating Officer of Bioject Medical from 1991 to 1994 and as Vice President Marketing and Sales/General Manager for Instromedix 13 from 1989 to 1991. From 1986 to 1989, Mr. Hollis served as a general manager of the Western business unit of Genentech, Inc., a manufacturer of biopharmaceuticals. Prior to joining Genentech, Mr. Hollis served as a divisional manager of Imed Corporation, Inc., a manufacturer of drug delivery systems. Mr. Hollis began his career in the health care industry with Baxter Travenol. Mr. Hollis received his B.A. in Psychology from San Francisco State University. Daniel D. Burgess became Chief Operating Officer and Chief Financial Officer of Hollis-Eden Pharmaceuticals, Inc. in August 1999. Mr. Burgess joined Hollis-Eden from Nanogen Inc., where he served as Vice President and Chief Financial Officer from 1998 to 1999. Prior to joining Nanogen, Mr. Burgess spent ten years with Gensia Sicor, Inc. (now Sicor, Inc.) and Gensia Automedics, Inc., a partially owned subsidiary of Gensia Sicor. He served as President and a director of Gensia Automedics, where he was responsible for all functional areas of this medical products company. In addition, he was Vice President and Chief Financial Officer of Gensia Sicor, where he was responsible for finance, investor relations, business development and other administrative functions. Mr. Burgess was instrumental in helping Gensia raise over $400 million in various public and private financings and was a key figure in a number of acquisitions and in-licensing and out-licensing transactions. Prior to joining Gensia, Mr. Burgess held positions at Castle & Cooke, Inc. and Smith Barney, Harris Upham and Company. He received a degree in Economics from Stanford University and a MBA from Harvard Business School. James M. Frincke, Ph.D. joined Hollis-Eden as Vice President, Research and Development in November 1997 and was promoted to Executive Vice President in March 1999. Dr. Frincke joined Hollis-Eden from Prolinx, Inc., where he served as Vice President, Therapeutics Research and Development from 1995 to 1997. During his 20 years in the biotechnology industry, Dr. Frincke has managed major development programs including drugs, biologicals, and cellular and gene therapy products aimed at the treatment of cancer, infectious diseases and organ transplantation. Since joining the biotechnology industry, Dr. Frincke has held vice president, research and development positions in top tier biotechnology companies including Hybritech/Eli Lilly and SyStemix (acquired by Novartis). In various capacities, he has been responsible for all aspects of pharmaceutical development including early stage research programs, product evaluation, pharmacology, manufacturing, and the management of regulatory and clinical matters of lead product opportunities. Dr. Frincke has authored or co-authored more than 100 scientific articles, abstracts and regulatory filings. Dr. Frincke received his B.S. in Chemistry and his Ph.D. in Chemistry, from the University of California, Davis. Dr. Frincke completed his postdoctoral work at the University of California, San Diego. Eric J. Loumeau became Vice President/Corporate General Counsel in September 1999. Mr. Loumeau came to Hollis-Eden from the law firm of Cooley Godward LLP, where he had primary responsibility for the Hollis-Eden account for four years. As a partner at Cooley Godward, Mr. Loumeau represented a number of private and public companies in corporate and securities law matters. Prior to joining Cooley Godward in 1995, Mr. Loumeau was an associate for four years at the law firm of Skadden, Arps, Slate, Meagher and Flom. Mr. Loumeau attended Harvard Law School and the University of California, Berkeley Boalt Hall School of Law, where he received a J.D.degree. He holds a B.S. degree in Business Administration with an emphasis in finance from Brigham Young University. Robert L. Marsella joined Hollis-Eden in September 1997 as Vice President of Business Development and Marketing. Mr. Marsella has over 20 years of medical sales, marketing, and distribution experience. From 1994 until he joined Hollis-Eden, Mr. Marsella was President of RLM Cardiac Products an exclusive distributor in the southwestern United States of various cardiac related hospital products. From 1990 until 1994 Mr. Marsella marketed and distributed implantable pacemakers and defibrillators for Telectronics Pacing Systems. From 1987 to 1990 Mr. Marsella served as Regional Manager for Genentech and launched ACTIVASE t-PATM (a biopharmaceutical drug) in the Western United States. From 1983 to 1987 Mr. Marsella marketed intravenous infusion pumps for Imed Corporation. Mr. Marsella began his healthcare career in 1980, as a field sales representative and later regional sales manager for U.S. Surgical Corporation, auto suture division. Mr. Marsella received his B.A. degree from San Diego State University in 1975. 14 Thomas C. Merigan, Jr., M.D. became Scientific Advisor and a director of Hollis-Eden in March 1996 and acts as our Medical Director for Infectious Diseases. Dr. Merigan has been George E. and Lucy Becker Professor of Medicine at Stanford University School of Medicine from 1980 to the present. Dr. Merigan has also been the Principal Investigator, NIAID Sponsored AIDS Clinical Trials Unit, from 1986 to the present and has been Director of Stanford University's Center For AIDS Research from 1988 to the present. Dr. Merigan is a member of various medical and honorary societies, has lectured extensively within and outside the United States, and authored numerous books and articles and has chaired and edited symposia relating to infectious diseases, including anti-viral agents, HIV and other retroviruses, and AIDS. From 1990 to the present, Dr. Merigan has been Chairman, Editorial Board of HIV: Advances in Research and Therapy. He is also a member of the editorial boards of Aids Research and Human Retroviruses (since 1983), International Journal of Anti-Microbial Agents (since 1990), and The Aids Reader (since 1991), among others. He is a co-recipient of ten patents which, among other things, relate to synthetic polynucleotides, modification of hepatitis B virus infection, treatment of HIV infection, purified cytomegalovirus protein and composition and treatment for herpes simplex. Dr. Merigan has been Chair, Immunology Advisory Board, Bristol Myers Squibb Corporation (1989--1995) and Chair, Scientific Advisory Board, Sequel Corp. (1993--1996). In 1994, Stanford University School of Medicine honored him with the establishment of the Annual Thomas C. Merigan Jr. Endowed Lectureship in Infectious Diseases, and, in 1996, Dr. Merigan was elected Fellow, American Association for the Advancement of Science. From 1966 to 1992, Dr. Merigan was Head, Division of Infectious Diseases, at Stanford School of Medicine. Dr. Merigan received his B.A. (with honors) from the University of California at Berkeley and his M.D. from the University of California at San Francisco. Christopher L. Reading, Ph.D. became Vice President of Scientific Development in December 1998. Prior to joining Hollis-Eden, Dr. Reading was Vice President of Product and Process Development at SyStemix Inc., a subsidiary of Novartis, Inc. During this time, he successfully filed three investigational new drug applications (INDs) in the areas of stem cell therapy technology for cancer and stem cell gene therapy for HIV/AIDS. Prior to joining SyStemix in 1993, Dr. Reading served on the faculty of the M.D. Anderson Cancer Center in Houston for 13 years. His positions there included Associate and Assistant Professor of Medicine in the Departments of Hematology and Tumor Biology. During his career, Dr. Reading has given more than 25 national and international scientific presentations, published more than 50 peer-reviewed journal articles and 15 invited journal articles as well as written nearly 20 book chapters, and has received numerous grants and contracts which supported his research activities. Dr. Reading has served on the National Science Foundation Advisory Committee for Small Business Innovative Research Grants (SBIR) as well as on the editorial boards of Journal of Biological Response Modifiers and Molecular Biotherapy. He holds numerous patents for his work with monoclonal antibodies and devices. He earned his B.A. in Cell Biology at the University of California at San Diego. Dr. Reading received his Ph.D. in Biochemistry at the University of California at Berkeley and completed postdoctoral study in tumor biology at The University of California at Irvine. Dwight Stickney, MD, was appointed Medical Director, Oncology in May 2000. Dr. Stickney joined Hollis-Eden from the Radiation Oncology Division of Radiological Associates of Sacramento Medical Group, Inc., in Sacramento, California where he served as an oncologist from 1993. While at Radiological Associates, he served as Chairman of the Radiation Oncology Division from 1997 to 1999 and was a member of the Radiation Study section of the National Institute of Health's Division of Research Grants from 1993 to 1997. He also served as the Director of Radiation Research for Scripps Clinic and Research Foundation in La Jolla, California from 1992 to 1993. Dr. Stickney has taught in medical academia as Associate Professor of Radiation Medicine at Loma Linda University School of Medicine and has served on the Board of Directors of the American Cancer Society. Earlier in his career Dr. Stickney held positions with Burroughs Wellcome and the Centers for Disease Control. He has also served as a consultant for a number of biotechnology companies on the design and conduct of clinical trials. Dr. Stickney holds a Bachelor of Science in Microbiology, a Masters of Science in Immunology, and a M.D. from Ohio State University. In addition, he is certified as a Diplomate of the American Board of Internal Medicine and Hematology, and a Diplomate of the American Board of Radiation Oncology. Robert W. Weber joined Hollis-Eden in March 1996 and currently serves as Chief Accounting Officer and Vice President-Controller. Mr. Weber has over twenty years of experience in financial management. Mr. Weber 15 has been employed at executive levels by multiple start-up companies and contributed to the success of several turnaround situations. He previously served as Vice President of Finance at Prometheus Products, a subsidiary of Sierra Semiconductor from 1994 to 1996, and Vice President Finance and Chief Financial Officer for Amercom, (a personal computer telecommunications software publishing company) from 1993 to 1994. From 1988 to 1993, Mr. Weber served as Vice President Finance and Chief Financial Officer of Instromedix, a company that develops and markets medical devices and software. Mr. Weber brings a broad and expert knowledge of many aspects of financial management. In various capacities, he has been responsible for all aspects of finance and accounting including cost accounting, cash management, SEC filings, investor relations, private and venture financing, corporate legal matters, acquisitions/divestitures as well as information services and computer automation. Mr. Weber received a B.S. from GMI Institute of Technology and a MBA from the Stanford Graduate School of Business. Risk Factors An investment in Hollis-Eden shares involves a high degree of risk. You should consider the following discussion of risks, in addition to other information contained in this annual report. This annual report also contains forward-looking statements that involve risks and uncertainties. If we do not obtain FDA regulatory approval for our products, we cannot sell our products and we will not generate revenues. Our principal development efforts are currently centered around immune regulating hormones, a class of drug candidates which we believe shows promise for the treatment of a variety of infectious diseases and immune system disorders. However, all drug candidates require U.S. FDA and foreign government approvals before they can be commercialized. Neither HE2000, our lead drug candidate, nor any of our other drug candidates have been approved for commercial sale. We expect to incur significant additional operating losses over the next several years as we fund development, clinical testing and other expenses while seeking regulatory approval. While limited clinical trials of HE2000 have to date produced favorable results, significant additional trials are required, and we may not be able to demonstrate that this drug candidate is safe or effective. We cannot guarantee that any of our product candidates will obtain required government approval. If we do not receive FDA or foreign approvals for our products, we will not be able to sell our products and will not generate revenues. If we do not successfully commercialize our products, we may never achieve profitability. We have experienced significant operating losses to date because of the substantial expenses we have incurred to acquire and fund development of our drug candidates. We have never had operating revenues and have never commercially introduced a product. Our accumulated deficit was approximately $48 million through December 31, 2000. Many of our research and development programs are at an early stage. Potential drug candidates are subject to inherent risks of failure. These risks include the possibilities that no drug candidate will be found safe or effective, meet applicable regulatory standards or receive the necessary regulatory clearances. Even safe and effective drug candidates may never be developed into commercially successful drugs. If we are unable to develop safe, commercially viable drugs, we may never achieve profitability. If we become profitable, we may not remain profitable. As a result of our intensely competitive industry, we may not gain enough market share to be profitable. The biotechnology and pharmaceutical industries are intensely competitive. We have numerous competitors in the United States and elsewhere. Our competitors include major, multinational pharmaceutical and chemical companies, specialized biotechnology firms and universities and other research institutions. Many of these competitors have greater financial and other resources, larger research and development staffs and more effective marketing and manufacturing organizations than we do. In addition, academic and government institutions have become increasingly aware of the commercial value of their research findings. These institutions are now more 16 likely to enter into exclusive licensing agreements with commercial enterprises, including our competitors, to market commercial products. Our competitors may succeed in developing or licensing technologies and drugs that are more effective or less costly than any we are developing. Our competitors may succeed in obtaining FDA or other regulatory approvals for drug candidates before we do. We cannot guarantee that our drug candidates, if approved for sale, will be able to compete successfully with our competitors' existing products under development. If we are unable to compete successfully, we may never be able to sell enough products at a sufficient price that would permit us to generate profits. Failure to protect our proprietary technology could impair our competitive position. We have developed and licensed numerous issued patents and pending applications in the U.S. and foreign counterparts. Our success will depend in part on our ability to obtain additional United States and foreign patent protection for our drug candidates and processes, preserve our trade secrets and operate without infringing the proprietary rights of third parties. We place considerable importance on obtaining patent protection for significant new technologies, products and processes. Legal standards relating to the validity of patents covering pharmaceutical and biotechnology inventions and the scope of claims made under such patents are still developing. Our patent position is highly uncertain and involves complex legal and factual questions. We cannot be certain that the applicant or inventors of subject matter covered by patent applications or patents owned by or licensed to us were the first to invent or the first to file patent applications for such inventions. We cannot guarantee that any patents will issue from any of the pending or future patent applications we own or have licensed. Existing or future patents owned by or licensed to us may be challenged, infringed upon, invalidated, found to be unenforceable or circumvented by others. Further, we cannot guarantee that any rights we may have under any issued patents will provide us with sufficient protection against competitive products or otherwise cover commercially valuable products or processes. Litigation or other disputes regarding patents and other proprietary rights may be expensive, cause delays in bringing products to market and harm our ability to operate. The manufacture, use or sale of our drug candidates may infringe on the patent rights of others. If we are unable to avoid infringement of the patent rights of others, we may be required to seek a license, 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, and fail to successfully defend an infringement action or to have infringing patents declared invalid, we may: . Incur substantial money damages; . Encounter significant delays in bringing our drug candidates to market; and/or . Be precluded from participating in the manufacture, use or sale of our drug candidates or methods of threatment without first obtaining licenses to do so. We cannot guarantee that we will be able to obtain any required license on favorable terms, if at all. In addition, if another party claims the same subject matter or subject matter overlapping with the subject matter that we have claimed in a United States patent application or patent, we may decide or be required to participate in interference proceedings in the United States Patent and Trademark Office in order to determine the priority of invention. Loss of such an interference proceeding would deprive us of patent protection sought or previously obtained and could prevent us from commercializing our products. Participation in such proceedings could result in substantial costs, whether or not the eventual outcome is favorable. These additional costs could adversely affect our financial results. 17 Confidentiality agreements with employees and others may not adequately prevent disclosure of trade secrets and other proprietary information. In order to protect our proprietary technology and processes, we also rely in part on confidentiality agreements with our corporate partners, employees, consultants, outside scientific collaborators and sponsored researchers and other advisors. 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 trade secrets and proprietary information. 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. Existing pricing regulations and reimbursement limitations may reduce our potential profits from the sale of our products. The requirements governing product licensing, pricing and reimbursement vary widely from country to country. Some countries require approval of the sale price of a drug before it can be marketed. In many countries, the pricing review period begins after product licensing approval is granted. As a result, we may obtain regulatory approval for a product in a particular country, but then be subject to price regulations that reduce our profits from the sale of the product. In some foreign markets pricing of prescription pharmaceuticals is subject to continuing government control even after initial marketing approval. In addition, certain governments may grant third-parties a license to manufacture our products without our permission. Such compulsory licenses typically would be on terms that are less favorable to us and would have the effect of reducing our profits. Varying price regulation between countries can lead to inconsistent prices and some re-selling by third parties of our products from markets where our products are sold at lower prices to markets where our products are sold at higher prices. This practice of exploiting price differences between countries can undermine our sales in markets with higher prices and reduce our potential sales. Our ability to commercialize our products successfully also will depend in part on the extent to which reimbursement for the cost of our products and related treatments will be available from government health administration authorities, private health insurers and other organizations. Third-party payors are increasingly challenging the prices charged for medical products and services. If we succeed in bringing HE2000 and/or our other potential products to the market, we cannot assure you that such products will be considered cost effective and that reimbursement will be available or will be sufficient to allow us to sell such products on a competitive basis. We will need to raise additional money before we expect to achieve profitability; if we fail to raise additional money, it would be difficult to continue our business. As of December 31, 2000 our cash and cash equivalents totaled approximately $34 million. We believe these financial resources will fund our current operations well into 2002. However, changes in our research and development plans or other events affecting our operating expenses may result in the expenditure of such cash before that time. We will require substantial additional funds in order to finance our drug discovery and development programs, fund operating expenses, pursue regulatory clearances, develop manufacturing, marketing and sales capabilities, and prosecute and defend our intellectual property rights. We intend to seek additional funding through public or private financing or through collaboration arrangements with collaborative partners. You should be aware that in the future: . we may not obtain additional financial resources when necessary or on terms favorable to us, if at all; and . any available additional financing may not be adequate. If we cannot raise additional funds when needed or on acceptable terms, we would not be able to continue to develop HE2000 or any of our other product candidates. 18 If we raise additional money by issuing equity securities, your investment will be diluted. If we raise additional funding by issuing more equity securities, the new shares will dilute the voting power of your investment on a percentage basis. We may not be able to keep up with the rapid technological change in the biotechnology and pharmaceutical industries, which could make our products obsolete and reduce our revenues. Biotechnology and related pharmaceutical technology have undergone rapid and significant change. We expect that the technologies associated with biotechnology research and development will continue to develop rapidly. Our future will depend in large part on our ability to maintain a competitive position with respect to these technologies. Any compounds, products or processes that we develop may become obsolete before we recover any expenses we have incurred in connection with developing these products. If we fail to recover our expenses because our products become obsolete, we may not be able to achieve profitability. Delays in the conduct or completion of our clinical trials or the analysis of the data from our clinical trials may result in delays in our planned filings for regulatory approvals, or adversely affect our ability to enter into collaborative arrangements. We cannot predict whether we will encounter problems with any of our completed or ongoing clinical studies that will cause us or regulatory authorities to delay or suspend our ongoing clinical studies or delay the analysis of data from our completed or ongoing clinical studies. If the results of our ongoing and planned clinical studies for HE2000 and HE2200 are not available when we expect or if we encounter any delay in the analysis of our clinical studies for HE2000 and HE2200: . we may not have the financial resources to continue research and development of any of our product candidates; and . we may not be able to enter into collaborative arrangements relating to any product subject to delay in regulatory filing. Any of the following reasons could delay or suspend the completion of our ongoing and future clinical studies: . delays in enrolling volunteers; . lower than anticipated retention rate of volunteers in a trial; . unfavorable efficacy results; or . serious side effects experienced by study participants relating to the product candidate. If the manufacturers of our products do not comply with FDA regulations, or cannot produce the amount of products we need to continue our development, we will fall behind on our business objectives. Outside manufacturers currently produce our drug candidates. Manufacturers producing our products must follow current Good Manufacturing Practices regulations enforced by the FDA through its facilities inspection program. If a manufacturer of our products does not conform to the Good Manufacturing Practices regulations and cannot be brought up to such a standard, we will be required to find alternative manufacturers that do conform. This may be a long and difficult process, and may delay our ability to receive FDA approval of our products. We also rely on our manufacturers to supply us with a sufficient quantity of our drug candidates to conduct clinical trials. If we have difficulty in the future obtaining our required quantity and quality of supply, we could experience significant delays in our development programs and regulatory process. 19 If we decide to manufacture our products ourselves, we face further FDA regulation and will require additional capital. At this time, we do not intend to manufacture any pharmaceutical products ourselves. If we decide to manufacture products ourselves in the future, we would be subject to the same risks associated with the regulatory requirements described above. We would also require substantial additional capital. We have no experience manufacturing pharmaceutical products for commercial purposes, so we cannot guarantee that we would be able to manufacture any products successfully or in a cost-effective manner. Our ability to achieve any significant revenue will depend on our ability to establish effective sales and marketing capabilities. Our efforts to date have focused on the development and evaluation of our drug candidates. As we continue clinical studies and prepare for commercialization of our drug candidates, we may need to build a sales and marketing infrastructure. We have no experience in the sales and marketing of our drug candidates. If we fail to establish a sufficient marketing and sales force, it will impair our ability to commercialize our product candidates and to enter new or existing markets. Our inability to effectively enter these markets would materially and adversely affect our ability to generate significant revenues. If we were to lose the services of Richard B. Hollis, or fail to attract or retain qualified personnel in the future, our business objectives would be more difficult to implement, adversely affecting our operations. Our ability to successfully implement our business strategy depends highly upon our Chief Executive Officer, Richard B. Hollis. The loss of Mr. Hollis' services could impede the achievement of our objectives. We also highly depend on our ability to hire and retain qualified scientific and technical personnel. The competition for these employees is intense. We cannot guarantee that we will continue to be able to hire and retain the qualified personnel needed for our business. Loss of the services of or the failure to recruit key scientific and technical personnel could adversely affect our business, operating results and financial condition. We may face product liability claims related to the use or misuse of our products which may cause us to incur significant losses. We face inherent business risk of product liability claims in the event that the use or misuse of our products results in personal injury or death. We have not experienced any such claims to date, but we cannot be certain, in particular after commercial introduction of our products, that we will not experience losses due to product liability claims. We currently maintain liability insurance on a claims-made basis. We cannot be certain that the insurance policies' coverage limits are adequate. The insurance is expensive, difficult to obtain and may not be available in the future on acceptable terms, or at all. Any claims against us, regardless of their merit, could substantially increase our costs and cause us to incur significant losses. Trading in our shares could be subject to extreme price fluctuations that could adversely affect your investment. The market prices for securities of life sciences companies, particularly those that are not profitable, have been highly volatile, especially recently. Publicized events and announcements may have a significant impact on the market price of our common stock. For example: . biological or medical discoveries by competitors; . public concern about the safety of our product candidates; . unfavorable results from clinical trials; . unfavorable developments concerning patents or other proprietary rights; or . unfavorable domestic or foreign regulatory developments; 20 may have the effect of temporarily or permanently driving down the price of our common stock. For example, our stock price has ranged from $3.62 to $19.25 between January 1, 2000 and March 15, 2001. In addition, the stock market from time to time experiences extreme price and volume fluctuations which particularly affect the market prices for emerging and life sciences companies, such as ours, and which are often unrelated to the operating performance of the affected companies. These broad market fluctuations may adversely affect the ability of a stockholder to dispose of his shares at a price equal to or above the price at which the shares were purchased. In addition, in the past, following periods of volatility in the market price of a company's securities, securities class-action litigation has often been instituted against those companies. This type of litigation, if instituted, could result in substantial costs and a diversion of management's attention and resources, which could materially adversely affect our business, financial condition and results of operations. Because stock ownership is concentrated, you and other investors will have minimal influence on stockholders' decisions. Assuming that outstanding warrants and options have not been exercised, Richard B. Hollis, our Chief Executive Officer, owns approximately 24% of our outstanding common stock. Assuming the exercise of our outstanding warrants and options, Mr. Hollis would own approximately 20% of our outstanding common stock. As a result, Mr. Hollis may be able to significantly influence the management of Hollis-Eden and all matters requiring stockholder approval, including the election of directors. Such concentration of ownership may also have the effect of delaying or preventing a change in control of Hollis-Eden. We have implemented anti-takeover provisions, any of which may reduce the market price of our common stock. Provisions of our certificate of incorporation and bylaws could make it more difficult for a third party to acquire us, even if the acquisition would be beneficial to our stockholders. Our board of directors is authorized, without any further vote by stockholders, to issue shares of preferred stock. The issuance of preferred stock with special voting, liquidation and dividend privileges may have the effect of delaying, deferring or preventing a change in control without any further action by the stockholders. Any such issuance may materially and adversely affect the price of the common stock. Our board of directors is a "classified board," with approximately one- third of our directors elected each year. Two annual meetings would be necessary to change a majority of the directors as a result of having a classified board. The existence of a classified board may, in certain circumstances, deter or delay mergers, tender offers, other possible takeover attempts or changes in management of the board of directors which may be favored by some or a majority of our stockholders. We have distributed a dividend of one right for each outstanding share of common stock pursuant to the terms of our stockholder rights plan. These rights will cause substantial dilution to the ownership of a person or group that attempts to acquire us on terms not approved by our board of directors and may have the effect of deterring hostile takeover attempts. Item 2. Properties Our corporate headquarters are located at 9333 Genesee Avenue, Suites 110 and 200, San Diego, California 92121, where we lease approximately 17,000 square feet. The leases expire in August 2002. We believe that our facilities are adequate for our current operations. Item 3. Legal Proceedings From time to time, we may be involved in litigation relating to claims arising out of our operations in the normal course of business. As of the date of this Annual Report on Form 10-K, we are not engaged in any legal proceedings that are expected, individually or in the aggregate, to have a material adverse effect on our business, financial condition or operating results. 21 Item 4. Submission of Matters to a Vote of Security Holders No matters were submitted to a vote of security holders during the fourth quarter of fiscal 2000. PART II Item 5. Market for Registrant's Common Stock and Related Stockholder Matters Our common stock is traded on the Nasdaq National Market System under the symbol HEPH. The following table sets forth the quarterly high and low bid quotations and/or selling prices for our securities during the last two fiscal years.
Common Stock High Low ------------ ------- ------- 1999 First Quarter.............................................. $25.500 $13.250 Second Quarter............................................. 18.750 10.000 Third Quarter.............................................. 16.000 11.000 Fourth Quarter............................................. 18.625 8.625 2000 First Quarter.............................................. $19.250 $10.125 Second Quarter............................................. 17.438 7.750 Third Quarter.............................................. 13.375 7.719 Fourth Quarter............................................. 9.188 4.000
On March 15, 2001, the closing price of our Common Stock as reported by the Nasdaq National Market System was $3.81 per share. There were approximately 5,000 shareholders of record plus beneficial stockholders of our Common Stock as of such date. We have not paid cash dividends on our common stock and do not intend to do so in the foreseeable future. On October 11, 2000, we issued 208,681 shares of Common Stock to Aeson Therapeutics, Inc. in connection with our purchase of a 21% equity stake in Aeson. These shares were deemed to be exempt from registration under the Securities Act by virtue of Section 4(2) and/or Regulation D promulgated thereunder. 22 Item 6. Selected Financial Data The following data summarizes certain selected financial data for each of the five years ended December 31, 2000 and the period from inception (August 15, 1994) to December 31, 2000. The information presented should be read in conjunction with the financial statements and related notes included elsewhere in this report (In thousands, except per share amounts).
Period from Inception As of or for the Year Ended December 31, (Aug. 15, 1994) -------------------------------------------------- to December 31, 2000 1999 1998 1997 1996 2000 -------- -------- ------- ------- ------ --------------- Statement of Operations Data: Research and development........... $ 17,933 (1) $ 5,731 $ 2,777 $ 3,488 $ 184 $ 31,770 General and administrative........ 4,157 11,940 (2) 3,577 2,044 511 22,476 -------- -------- ------- ------- ------ -------- Total operating expenses.............. 22,090 17,671 6,354 5,532 695 54,246 Other income (expense)............. 2,575 2,351 927 280 3 6,090 -------- -------- ------- ------- ------ -------- Net loss............... $(19,515) $(15,320) $(5,427) $(5,253) $ (692) $(48,156) ======== ======== ======= ======= ====== ======== Net loss per share, basic and diluted..... $ (1.74) $ (1.41) $ (0.69) $ (0.85) $(0.15) Weighted average number of common shares outstanding........... 11,240 10,861 7,851 6,193 4,658 Balance Sheet Data: Cash and equivalents... $ 34,298 $ 47,486 $24,190 $ 7,103 $ 18 Total assets........... 35,099 48,265 24,524 7,400 241 Accounts payable and accrued expenses...... 2,636 1,640 222 467 807 Stockholders' equity (deficit)............. $ 32,463 $ 46,625 $24,303 $ 6,933 $ (566)
- - -------- (1) 2000 Research and Development expenses include $4.5 million for non-cash charges for the purchase of technology and in-process R&D. (2) 1999 General and Administrative expenses include $7.7 million for non-cash charges, due to the acceleration of vesting of stock options for a former officer, the issuance of warrants for services, and the issuance of stock options to non-employees. Item 7. Management's Discussion and Analysis of Results of Operations and Financial Condition Management's Discussion and Analysis of Results of Operations and Financial Condition The forward-looking comments contained in the following discussion involve risks and uncertainties. Our actual results may differ materially from those discussed here. Factors that could cause or contribute to such differences can be found in the following discussion and elsewhere throughout this Annual Report on Form 10-K. General Hollis-Eden Pharmaceuticals, Inc., a development-stage pharmaceutical company, is presently engaged in the discovery and development of products for the treatment of infectious diseases and immune system disorders, including HIV/AIDS, hepatitis B and C, and malaria. We are focusing our initial development efforts on a potent series of immune regulating hormones and hormone analogs. Our lead compound in this series, HE2000, is currently in Phase II clinical studies. By altering cytokine production HE2000 appears from early clinical studies to help reestablish immune system balance in 23 situations such as HIV where the immune system is dysregulated. In the case of HIV, we believe that by reestablishing this balance the immune system may be able to better control virus levels and potentially delay or prevent the progression to AIDS. In addition, based on the mechanism of action, we believe these compounds will have an attractive safety profile and will avoid issues of resistance that plague many existing antiviral drugs. We have been unprofitable since our inception and we expect to incur substantial additional operating losses for at least the next few years as we increase expenditures on research and development and begins to allocate significant and increasing resources to clinical testing and other activities. In addition, during the next few years, we may have to meet the substantial new challenge of developing the capability to market products. Accordingly, our activities to date are not as broad in depth or scope as the activities we must undertake in the future, and our historical operations and financial information are not indicative of the future operating results or financial condition or ability to operate profitably as a commercial enterprise when and if we succeed in bringing any drug candidates to market. On March 26, 1997, Hollis-Eden, Inc., a Delaware corporation, was merged with and into us, then known as Initial Acquisition Corp. ("IAC"), a Delaware corporation. Upon consummation of the merger of Hollis-Eden, Inc. with IAC (the "Merger"), Hollis-Eden, Inc. ceased to exist, and IAC changed its name to Hollis-Eden Pharmaceuticals, Inc. Results of Operations We have not generated any revenues for the period from August 15, 1994 (inception of Hollis-Eden) through December 31, 2000. We have devoted substantially all of our resources to the payment of licensing fees and research and development expenses plus expenses related to the startup of our business. From inception until December 31, 2000, we have incurred expenses of approximately $31.8 million in research and development and $22.5 million in general and administrative expenses, which have been partially offset by $6.1 million in net interest income resulting in a loss of $48.2 million for the period. Research and development expenses were $17.9 million, $5.7 million and $2.8 million in 2000, 1999 and 1998, respectively. The research and development expenses relate primarily to the ongoing development, preclinical testing, and clinical trials for our first drug candidate, HE2000. $4.5 million of the increase in research and development in 2000 was non-cash charges related to the acquisition of technology and in-process R&D. The balance of the increase was due to increased staffing, preclinical activity, and clinical trials. 1999 research and development expenses increased compared to 1998 due to increased staffing, preclinical activity, and the initiation of clinical trials. General and administrative expenses remained flat in 2000 compared to 1999 excluding the non-cash charges in 1999 of $7.7 million. The $7.7 million of non-cash charges was due to the acceleration of vesting of stock options for a former officer of Hollis-Eden, the issuance of warrants for services (described below), and the issuance of stock options to non-employees. During 1999, general and administrative expenses increased $0.6 million from 1998 due to increased staffing and increased operating expenses for salaries, benefits, recruiting, legal, and travel. During 1999, we announced the resignation of an executive officer and accelerated the vesting of 300,000 stock options previously granted to him. This acceleration was considered to be a new grant of options and therefore we expensed a one-time non-cash charge of $4.9 million. We also entered into a three-year agreement with a financial consulting organization affiliated with a director of Hollis-Eden. We agreed to issue, as compensation for services, warrants to purchase 500,000 shares of Common Stock with an exercise price of $20.50 per share. The warrants were estimated to have a value of approximately $2.1 million, which was expensed as a non-cash charge. In 1998, we incurred additional general and administrative non-cash, non- recurring charges of $956,000. A total of $716,000 was amortized during 1998 for services in lieu of cash and for non-cash compensation. In addition, $240,000 was expensed for options granted to certain directors and consultants. 24 Liquidity and Capital Resources We have financed our operations since inception through the sale of shares of Common Stock. During the year ended December 31, 1995, we received cash proceeds of $250,000 from the sale of securities. In May 1996, we completed a private placement of shares of Common Stock, from which we received aggregate gross proceeds of $1.3 million. In March 1997, the Merger of IAC and Hollis- Eden, Inc. provided us with $6.5 million in cash and other receivables. In May 1998, we completed a private placement of shares and warrants, from which we received gross proceeds of $20 million. During January 1999, we completed two private placements raising approximately $25 million. In addition, Hollis-Eden has received a total of $13 million from the exercise of warrants and stock options. Our operations to date have consumed substantial capital without generating any revenues, and we will continue to require substantial and increasing amounts of funds to conduct necessary research and development and preclinical and clinical testing of our drug candidates, and to market any drug candidates that receive regulatory approval. We do not expect to generate revenue from operations for the foreseeable future, and our ability to meet our cash obligations as they become due and payable is expected to depend for at least the next several years on our ability to sell securities, borrow funds or some combination thereof. Based upon our current plans, we believe that our existing capital resources, together with interest thereon, will be sufficient to meet our operating expenses and capital requirements well into 2002. However, changes in our research and development plans or other events affecting our operating expenses may result in the expenditure of such cash before that time. We may not be successful in raising necessary funds. Our future capital requirements will depend upon many factors, including progress with preclinical testing and clinical trials, the number and breadth of our programs, the time and costs involved in preparing, filing, prosecuting, maintaining and enforcing patent claims and other proprietary rights, the time and costs involved in obtaining regulatory approvals, competing technological and market developments, and our ability to establish collaborative arrangements, effective commercialization, marketing activities and other arrangements. We expect to continue to incur increasing negative cash flows and net losses for the foreseeable future. Item 7A. Quantitative and Qualitative Disclosures About Market Risk Not applicable. Item 8. Financial Statements and Supplementary Data The information required by this item is provided in a separate section beginning on page F-1. Item 9. Changes in and Disagreements with Accountants on Accounting and Financial Disclosures Not applicable. 25 PART III Item 10. Directors and Executive Officers of the Registrant See the section entitled "Executive Officers and Senior Management" in Part I, Item 1 hereof for information regarding executive officers and senior management. The information required by this item with respect to directors is incorporated by reference from the information under the heading "Election of Directors," contained in Hollis-Eden's definitive Proxy Statement to be filed with the Commission pursuant to Regulation 14A in connection with the 2001 Annual Meeting (the "Proxy Statement"). Item 11. Executive Compensation The information concerning executive compensation is set forth in the Proxy Statement under the heading "Executive Compensation," which information is incorporated herein by reference. Item 12. Security Ownership of Certain Beneficial Owners and Management The information concerning security ownership of certain beneficial owners and management is set forth in the Proxy Statement under the heading "Security Ownership of Certain Beneficial Owners and Management," which information is incorporated herein by reference. Item 13. Certain Relationships and Related Transactions The information concerning certain relationships and related transactions is set forth in the Proxy Statement under the heading "Certain Transactions," which information is incorporated herein by reference. 26 PART IV Item 14. Exhibits, Financial Statement Schedules and Reports on Form 8-K (a) List of documents filed as part of this Annual Report to Stockholders on Form 10-K: 1. Financial Statements: The financial statements of Hollis-Eden Pharmaceuticals are included as Appendix F of this report. See Index to Financial Statements on page F-1. 2. Financial Statement Schedules: Financial statement schedules required under the related instructions are not applicable for the three years ended December 31, 2000, and have therefore been omitted. 3. Exhibits: The exhibits which are filed with this Report or which are incorporated herein by reference are set forth in the Exhibit Index on page E-1. (b) Reports on Form 8-K On October 20, 2000, we filed a report on Form 8-K dated October 11, 2000 with the SEC announcing that we acquired a 21% equity stake in Aeson Therapeutics and an exclusive worldwide sublicense to three issued patents in the area of adrenal steroids in exchange for $2 million in cash and 208,681 shares of Common Stock. 27 SIGNATURES Pursuant to the requirements of the Section 13 or 15(d) of the Securities Exchange Act of 1934, the registrant has duly caused this report to be signed on its behalf by the undersigned, thereunto duly authorized on March 28, 2001 HOLLIS-EDEN PHARMACEUTICALS, INC. By:/s/ Richard B. Hollis ---------------------------------- Richard B. Hollis, Chairman of the Board of Directors, and Chief Executive Officer KNOW ALL PERSONS BY THESE PRESENTS, that each person whose signature appears below constitutes and appoints RICHARD B. HOLLIS, DANIEL D. BURGESS and ROBERT W. WEBER, and each of them, as his true and lawful attorneys-in- fact and agents, with full power of substitution and resubstitution, for him and in his name, place, and stead, in any and all capacities, to sign any and all amendments to this Report, and to file the same, with all exhibits thereto, and other documents in connection therewith, with the Securities and Exchange Commission, granting unto said attorneys-in-fact and agents, and each of them, full power and authority to do and perform each and every act and thing requisite and necessary to be done in connection therewith, as fully to all intents and purposes as he might or could do in person, hereby ratifying and confirming that all said attorneys-in-fact and agents, or any of them or their or his substitute or substituted, may lawfully do or cause to be done by virtue hereof. Pursuant to the requirements of the Securities Exchange Act of 1934, this report has been signed by the following persons in the capacities and on the dates indicated.
Signature Title Date --------- ----- ---- /s/ Richard B. Hollis Chairman of the Board of March 28, 2001 ____________________________________ Directors, President and Richard B. Hollis Chief Executive Officer /s/ Daniel D. Burgess Chief Operating March 28, 2001 ____________________________________ Officer/Chief Financial Daniel D. Burgess Officer (Principal Financial Officer) /s/ Robert W. Weber Chief Accounting Officer and March 28, 2001 ____________________________________ Vice President - Controller Robert W. Weber (Principal Accounting Officer) /s/ Paul Bagley Director March 28, 2001 ____________________________________ Paul Bagley /s/ Leonard Makowka Director March 28, 2001 ____________________________________ Leonard Makowka
28
Signature Title Date --------- ----- ---- /s/ Brendan R. McDonnell Director March 28, 2001 ____________________________________ Brendan R. McDonnell /s/ Thomas C. Merigan, Jr. M.D. Scientific Advisor and March 28, 2001 ____________________________________ Director Thomas C. Merigan, Jr. M.D. /s/ William H. Tilley Director March 28, 2001 ____________________________________ William H. Tilley /s/ Salvatore J. Zizza Director March 28, 2001 ____________________________________ Salvatore J. Zizza
29 APPENDIX E HOLLIS-EDEN PHARMACEUTICALS, INC. ANNUAL REPORT ON FORM 10-K ---------------- EXHIBIT INDEX
Exhibit Number Description of Document ------- ---------------------------------------------------------------------- 3.1 Amended and Restated Certificate of Incorporation of the Registrant (incorporated by reference to Exhibit 4.1 to Registrant's Registration Statement on Form S-4 (No. 333-18725), as amended (the "Form S-4" )). 3.2 Bylaws of Registrant (incorporated by reference to Exhibit 4.2 to the Form S-4). 3.3 Certificate of Designation of Series B Junior Participating Preferred Stock (incorporated by reference to Exhibit 4.1 to Registrant's Current Report on Form 8-K dated November 15, 1999). *10.1 Registrant's 1997 Incentive Stock Option Plan (the "Option Plan") (incorporated by reference to Exhibit 10.3 to the Form S-4). *10.2 Forms of Incentive Stock Options and Nonstatutory Stock Options under the Option Plan. (incorporated by reference to Exhibit 10.5 to the Form S-4). *10.3 Employment Agreement by and between Registrant and Richard B. Hollis dated November 1, 1996 (incorporated by reference to Exhibit 10.6 to the Form S-4). *10.4 Employment Agreement by and between Registrant and Robert W. Weber dated March 16, 1996 (incorporated by reference to Exhibit 10.9 to the Registrant's Annual Report on Form 10-K for the year ended December 31, 1998). *10.5 Consulting Agreement and Warrant by and between Registrant and William H. Tilley and Jacmar/Viking, L.L.C. dated March 8, 1999 (incorporated by reference to Exhibit 10.5 to the Registrant's Annual Report on Form 10-K for the year ended December 31, 1999). *10.6 Separation and Mutual Release Agreement by and between Registrant and Terren S. Peizer effective as of February 25, 1999 (incorporated by reference to Exhibit 10.10 to the Registrant's Quarterly Report on Form 10-Q for the quarter ended March 31, 1999). *10.7 Employment Agreement by and between Registrant and Daniel D. Burgess dated July 9, 1999 (incorporated by reference to Exhibit 10.10 to Registrant's Quarterly Report on Form 10-Q for the quarter ended September 30, 1999). *10.8 Employment Agreement by and between Registrant and Eric J. Loumeau dated September 15, 1999 (incorporated by reference to Exhibit 10.10 to Registrant's Quarterly Report on Form 10-Q for the quarter ended September 30, 1999). 10.9 Settlement and Mutual Release Agreement, dated January 20, 2000, among Registrant, Colthurst Limited, Edenland, Inc. and Patrick T. Prendergast (incorporated by reference to Exhibit 99.2 to Registrant's Current Report on Form 8-K dated January 20, 2000). 10.10 Technology Assignment Agreement, dated January 20, 2000, among Registrant, Colthurst Limited and Patrick T. Prendergast (incorporated by reference to Exhibit 99.3 to Registrant's Current Report on Form 8- K dated January 20, 2000).
E-1
Exhibit Number Description of Document ------- ---------------------------------------------------------------------- 10.11 Common Stock and Warrant Agreement, dated January 20, 2000, among Registrant and Colthurst Limited (incorporated by reference to Exhibit 99.4 to Registrant's Current Report on Form 8-K dated January 20, 2000). 10.12 Warrant, dated January 20, 2000, issued to Colthurst Limited (incorporated by reference to Exhibit 99.5 to Registrant's Current Report on Form 8-K dated January 20, 2000). 10.13 Sponsored Research and License Agreement, dated January 20, 2000, among Registrant, Edenland, Inc., Colthurst Limited and Patrick T. Prendergast (incorporated by reference to Exhibit 99.6 to Registrant's Current Report on Form 8-K dated January 20, 2000). 10.14 Indemnification Agreement among Registrant and Executive Offices and Directors. 23.1 Consent of BDO Seidman, LLP. 24.1 Power of Attorney. Reference is made to signature page.
- - -------- * Management contract or compensatory plan, contract or arrangement to be filed as an exhibit pursuant to Item 14(c) of Form 10-K. E-2 APPENDIX F HOLLIS-EDEN PHARMACEUTICALS, INC. Index To Financial Statements
Page ---- Report of Independent Certified Public Accountants........................ F-2 Balance Sheets as of December 31, 2000 and 1999........................... F-3 Statements of Operations for the Fiscal Years Ended December 31, 2000, December 31, 1999, December 31, 1998 and the Period From Inception (August 15, 1994) to December 31, 2000................................... F-4 Statements of Stockholders' Equity for the Fiscal Years Ended December 31, 1995, December 31, 1996, December 31, 1997, December 31, 1998, December 31, 1999, December 31, 2000 and the Period from Inception (August 15, 1994) to December 31, 1994............................................... F-5 Statements of Cash Flow for the Fiscal Years Ended December 31, 2000, December 31 1999, December 31, 1998 and the Period from Inception (August 15, 1994) to December 31, 2000........................................... F-7 Notes to Financial Statements............................................. F-8
F-1 REPORT OF INDEPENDENT CERTIFIED PUBLIC ACCOUNTANTS To the Board of Directors and Stockholders of Hollis-Eden Pharmaceuticals, Inc. San Diego, CA We have audited the accompanying balance sheets of Hollis-Eden Pharmaceuticals, Inc. (a development stage company) as of December 31, 2000 and 1999 and the related statements of operations, stockholders' equity, and cash flows for each of the three years in the period ended December 31, 2000 and for the period from inception (August 15, 1994) to December 31, 2000. These financial statements are the responsibility of the Company's management. Our responsibility is to express an opinion on these financial statements based on our audits. We conducted our audits in accordance with auditing standards generally accepted in the United States. Those standards require that we plan and perform the audit to obtain reasonable assurance about whether the financial statements are free of material misstatement. An audit includes examining, on a test basis, evidence supporting the amounts and disclosures in the financial statements. An audit also includes assessing the accounting principles used and significant estimates made by management, as well as evaluating the overall financial statement presentation. We believe that our audits provide a reasonable basis for our opinion. In our opinion, the financial statements referred to above present fairly in all material respects, the financial position of Hollis-Eden Pharmaceuticals, Inc. as of December 31, 2000 and 1999 and the results of its operations and its cash flows for each of the three years in the period ended December 31, 2000 and for the period from inception (August 15, 1994) to December 31, 2000, in conformity with accounting principles generally accepted in the United States. BDO Seidman, LLP New York, NY January 19, 2001 F-2 HOLLIS-EDEN PHARMACEUTICALS, INC. (A Development Stage Company) BALANCE SHEETS
December 31, ------------------ 2000 1999 -------- -------- (In thousands) ASSETS: Current assets: Cash and cash equivalents.................................. $ 34,298 $ 47,486 Prepaid expenses........................................... 96 115 Deposits................................................... 27 27 -------- -------- Total current assets....................................... 34,421 47,628 Property and equipment, net of accumulated depreciation of $204 and $97.............................................. 422 392 Receivable from related party (Note 5)..................... 256 245 -------- -------- Total assets............................................... $ 35,099 $ 48,265 ======== ======== LIABILITIES AND STOCKHOLDERS' EQUITY: Current liabilities: Accounts payable and accrued expenses...................... $ 2,636 $ 1,640 -------- -------- Total current liabilities.................................. 2,636 1,640 Commitments and contingencies (Notes 8, 13, 14) Stockholders' equity: (Notes 3, 4, 7, 9, 10, 11, 12) Preferred stock, no par value, 10,000 shares authorized; no shares outstanding................................... -- -- Common stock, $.01 par value, 30,000 shares authorized; 11,590 and 11,071 shares issued and outstanding, respectively............................................ 116 111 Paid-in capital.......................................... 80,503 75,155 Deficit accumulated during development stage............. (48,156) (28,641) -------- -------- Total stockholders' equity............................. 32,463 46,625 -------- -------- Total liabilities and stockholders' equity............. $ 35,099 $ 48,265 ======== ========
The accompanying notes are an integral part of these financial statements. F-3 HOLLIS-EDEN PHARMACEUTICALS, INC. (A Development Stage Company) STATEMENTS OF OPERATIONS
Period from Inception For the year ended (Aug. 15, 1994) December 31, to December 31, --------------------------- --------------- 2000 1999 1998 2000 -------- -------- ------- --------------- (In thousands, except per share amounts) Operating expenses: Research and development R&D operating expenses.......... $ 13,407 $ 5,731 $ 2,777 $ 26,590 R&D costs related to common stock and stock option grants for collaborations and technology purchase............ 4,526 -- -- 5,180 -------- -------- ------- -------- Total research and development.................. 17,933 5,731 2,777 31,770 General and administrative G&A operating expenses.......... 4,157 4,279 2,621 12,986 G&A costs related to options/warrants granted....... -- 7,661 956 9,490 -------- -------- ------- -------- Total general and administrative............... 4,157 11,940 3,577 22,476 -------- -------- ------- -------- Total operating expenses...... 22,090 17,671 6,354 54,246 Other income (expense): Interest income................... 2,575 2,351 929 6,140 Interest expense.................. -- -- (2) (50) -------- -------- ------- -------- Total other income................ 2,575 2,351 927 6,090 -------- -------- ------- -------- Net loss.......................... $(19,515) $(15,320) $(5,427) $(48,156) ======== ======== ======= ======== Net loss per share, basic and diluted.......................... $ (1.74) $ (1.41) $ (0.69) Weighted average number of common shares outstanding............... 11,240 10,861 7,851
The accompanying notes are an integral part of these financial statements F-4 HOLLIS-EDEN PHARMACEUTICALS, INC. (A Development Stage Company) STATEMENTS OF STOCKHOLDERS' EQUITY
Preferred Deficit stock at par Common stock accumulated value at par value Capital in during ------------- ------------- excess of Deferred development (In thousands) shares amount shares amount par value compensation stage Total - - -------------- ------ ------ ------ ------ ---------- ------------ ----------- ------- Contribution by stockholder............ -- $ -- -- $ -- $ 103 $ -- $ -- $ 103 Common stock issued for cash................... -- -- 2,853 -- 25 -- -- 25 Common stock issued as consideration for the license agreements (Note 8)............... -- -- 543 -- 5 -- -- 5 Net loss................ -- -- -- -- -- -- (1,277) (1,277) --- ----- ----- ----- ------- ------- -------- ------- Balance at December 31, 1994................... -- -- 3,396 -- 133 -- (1,277) (1,144) Common stock issued for cash................... -- -- 679 -- 250 -- -- 250 Common stock issued as consideration for amendments to the license agreements (Note 8)............... -- -- 76 -- 28 -- -- 28 Net loss................ -- -- -- -- -- -- (672) (672) --- ----- ----- ----- ------- ------- -------- ------- Balance at December 31, 1995................... -- -- 4,151 -- 411 -- (1,949) (1,538) Common stock issued in conversion of debt (Note 10).............. -- -- 165 -- 371 -- -- 371 Common stock issued for cash, net of expenses (Note 10).............. -- -- 580 -- 1,234 -- -- 1,234 Common stock issued as consideration for termination of a finance agreement...... -- -- 15 -- 34 -- -- 34 Warrants issued to consultants for services rendered...... -- -- -- -- 24 -- -- 24 Net loss................ -- -- -- -- -- -- (692) (692) --- ----- ----- ----- ------- ------- -------- ------- Balance at December 31, 1996................... -- -- 4,911 -- 2,074 -- (2,641) (567) Recapitalization of Company upon the merger with Initial Acquisition Corp. (Note 3)..................... -- -- 883 58 6,213 -- -- 6,271 Warrants issued to a certain director upon the successful closure of the merger.......... -- -- -- -- 570 -- -- 570 Exercise of warrants, net of expenses........ -- -- 978 10 5,619 -- -- 5,629 Deferred compensation-- stock options (Note 12).................... -- -- -- -- 1,848 (1,848) -- -- Amortization of deferred compensation........... -- -- -- -- -- 282 -- 282 Exercise of stock options................ -- -- -- -- 1 -- -- 1 Net loss................ -- -- -- -- -- -- (5,253) (5,253) --- ----- ----- ----- ------- ------- -------- ------- Balance at December 31, 1997................... -- -- 6,772 68 16,325 (1,566) (7,894) 6,933 Exercise of warrants.... -- -- 399 4 1,196 -- -- 1,200 Exercise of stock options................ -- -- 53 1 155 -- -- 156 Private Placement, net of expenses (Note 10).. 4 -- 1,329 13 19,877 -- -- 19,890 Warrants issued for services in lieu of cash (Note 9).......... -- -- -- -- 408 -- -- 408 Stock issued for license fee (Note 8)........... -- -- 33 -- 500 -- -- 500 Stock issued for services in lieu of cash................... -- -- 6 -- 95 -- -- 95 Options issued for services in lieu of cash (Note 12)......... -- -- -- -- 240 -- -- 240 Amortization of deferred compensation........... -- -- -- -- -- 308 -- 308 Net loss................ -- -- -- -- -- -- (5,427) (5,427) --- ----- ----- ----- ------- ------- -------- ------- Balance at December 31, 1998................... 4 $ -- 8,592 $ 86 $38,796 $(1,258) $(13,321) $24,303 --- ----- ----- ----- ------- ------- -------- -------
F-5 HOLLIS-EDEN PHARMACEUTICALS, INC. (A Development Stage Company) STATEMENTS OF STOCKHOLDERS' EQUITY--Cont.
Preferred Deficit stock at par Common stock accumulated value at par value Capital in during ------------- ------------- excess of Deferred development (In thousands) shares amount shares amount par value compensation stage Total - - -------------- ------ ------ ------ ------ ---------- ------------ ----------- -------- Exercise of warrants.... -- -- 755 8 5,136 -- -- 5,144 Exercise of stock options................. -- -- 10 -- 75 -- -- 75 Private Placement, net of expenses (Note 4).... -- -- 1,368 14 24,759 -- -- 24,773 Preferred Stock Conversion (Note 10,11).................. (4) -- 346 3 (3) -- -- -- Deferred compensation- Options forfeited (Note 12)..................... -- -- -- -- (1,207) 1,258 -- 51 Amortization of non- employee options........ -- -- -- -- 559 -- -- 559 Warrants issued for services in lieu of cash (Note 9)................ -- -- -- -- 2,140 -- -- 2,140 Options accelerated vesting (Note 12)....... -- -- -- -- 4,900 -- -- 4,900 Net loss................ -- -- -- -- -- -- (15,320) (15,320) --- ----- ------ --- -------- ----- --------- -------- Balance at December 31, 1999.................... -- -- 11,071 111 75,155 -- (28,641) 46,625 Exercise of warrants.... -- -- 133 2 758 -- -- 760 Exercise of stock options................. -- -- 1 -- 5 -- -- 5 Common Stock issued for 401k/401m plan.......... -- -- 6 -- 63 -- -- 63 Common Stock issued for R&D In-Process (Note 8)...................... -- -- 209 2 1,998 -- -- 2,000 Options granted for license fee............. -- -- 38 -- 598 -- -- 598 Amortization of non- employee options........ -- -- -- -- 79 -- -- 79 Common Stock issued for purchase of technology.. -- -- 132 1 1,847 -- -- 1,848 Net loss................ -- -- -- -- -- -- (19,515) (19,515) --- ----- ------ --- -------- ----- --------- -------- Balance at December 31, 2000.................... -- $ -- 11,590 116 $ 80,503 $ -- $ (48,156) $ 32,463 === ===== ====== === ======== ===== ========= ========
The accompanying notes are an integral part of these financial statements F-6 HOLLIS-EDEN PHARMACEUTICALS, INC. (A Development Stage Company) STATEMENTS OF CASH FLOWS
Period from Inception (Aug. 15, 1994) For the year ended December 31, to December 31, ---------------------------------- --------------- 2000 1999 1998 2000 ---------- ---------- ---------- --------------- (In thousands) Cash flows from operating activities: Net loss.................. $ (19,515) $ (15,320) $ (5,427) $ (48,156) Adjustments to reconcile net loss to net cash used in operating activities: Depreciation.............. 107 68 21 204 Common stock issued for 401k/401m plan........... 63 -- -- 63 Common stock issued as consideration for amendments to the license agreements............... -- -- -- 33 Common stock issued as consideration for termination of a finance agreement................ -- -- -- 34 Common stock and options issued as consideration for license fees and services................. 677 -- 1,003 1,694 Expense related to warrants issued as consideration to consultants.............. -- 2,140 -- 2,140 Expense related to warrants issued to a director for successful closure of merger........ -- -- -- 570 Expense related to stock options issued........... -- 4,900 240 5,140 Expense related to common stock issued for the purchase of technology... 1,848 -- -- 1,848 Common stock issued as consideration for In- Process R&D.............. 2,000 -- -- 2,000 Deferred compensation expense related to options issued........... -- 620 308 1,210 Changes in assets and liabilities: Prepaid expenses.......... 19 (89) 17 (96) Deposits.................. -- (18) -- (27) Receivable--tax refund.... -- -- 105 -- Loan receivable from related party............ (12) (38) (160) (256) Accounts payable and accrued expenses......... 916 909 103 2,055 Wages payable............. 81 500 -- 581 License fees payable to related party............ -- -- -- -- R & D fees payable to related party............ -- -- (338) -- Disposal of assets........ -- 7 -- 7 ---------- ---------- --------- --------- Net cash used in operating activities.... (13,816) (6,321) (4,128) (30,956) Cash flows provided by investing activities: Purchase of property and equipment................ (137) (375) (31) (632) ---------- ---------- --------- --------- Net cash used in investing activities.... (137) (375) (31) (632) Cash flows from financing activities: Contributions from stockholder.............. -- -- -- 104 Net proceeds from sale of preferred stock.......... -- -- 4,000 4,000 Net proceeds from sale of common stock............. -- 24,773 15,890 42,172 Proceeds from issuance of debt..................... -- -- -- 371 Net proceeds from recapitalization......... -- -- -- 6,271 Net proceeds from warrants/options exercised................ 765 5,219 1,356 12,968 ---------- ---------- --------- --------- Net cash from financing activities.............. 765 29,992 21,246 65,886 Net increase in cash and equivalents................ (13,188) 23,296 17,087 34,298 Cash and equivalents at beginning of period........ 47,486 24,190 7,103 -- ---------- ---------- --------- --------- Cash and equivalents at end of period.................. $ 34,298 $ 47,486 $ 24,190 $ 34,298 ========== ========== ========= ========= Supplemental disclosure of cash flow information: Interest paid............... $ -- $ -- $ 2 $ 46 Conversion of debt to equity..................... -- -- -- 371 Options issued to consultants in lieu of cash, no vesting........... -- -- -- 24 Warrants issued in lieu of cash, commissions on private placement.......... -- 600 -- 733
The accompanying notes are an integral part of these financial statements. F-7 HOLLIS-EDEN PHARMACEUTICALS, INC. (A Development Stage Company) NOTES TO FINANCIAL STATEMENTS 1. The Company Hollis-Eden Pharmaceuticals Inc. ("Hollis Eden" or the "Company"), a development stage pharmaceutical company, is engaged in the discovery, development and commercialization of products for the treatment of infectious diseases and immune system disorders, including HIV/AIDS, hepatitis B and C and malaria. Since its inception (August 15, 1994) through March 1997, the Company's efforts were directed toward organizing, licensing technology and preparing for offerings of shares of its common stock. Since 1997, the Company has been expanding its intellectual property, developing its lead drug candidates, performing preclinical tests and has entered into several human clinical trials. The Company is focusing its initial development efforts on a potent series of immune regulating hormones and hormone analogs. The lead compound in this series, HE2000, is currently in Phase II clinical studies. To date, the Company has not developed commercial products or generated sales for the period from August 15, 1994 through December 31, 2000. 2. Summary of Accounting Policies Cash Equivalents The Company considers any liquid investments with a maturity of three months or less when purchased to be cash equivalents. Because of the short maturities of these investments, the carrying amount is a reasonable estimate of fair value. At December 31, 2000, the Company's cash equivalents totaling $34.3 million were deposited primarily in a money market mutual fund with a large financial institution. Property and Equipment Property and equipment is stated at cost and depreciated over the estimated useful lives of the assets (five and seven years) using the straight-line method. Research and development Research and development costs consist of license fee expenses related to license agreements, preclinical and clinical trial expenses, as well as research and development expenses with related parties. Such amounts paid or payable to related parties aggregated zero in 2000, and $0.5 million and $1.3 million for the years ended December 31, 1999 and 1998, respectively, and $6.3 million for the period from inception (August 15, 1994) to December 31, 2000. Such expenses are recognized as incurred. During October 2000, the Company incurred an expense of $4.0 million comprised of $2.0 million in cash and 208,681 shares of Hollis Eden Common Stock for a 21% equity stake and an exclusive worldwide sublicense to three issued patents (see Note 8, "Aeson Therapeutics"). Income Taxes The Company provides for income taxes under the principles of Statement of Financial Accounting Standards No. 109 (SFAS 109) which requires that provision be made for taxes currently due and for the expected future tax effects of temporary differences between book and tax bases of assets and liabilities. Financial instruments The Company's financial instruments consist primarily of cash, other receivables and accounts payable. These financial instruments are stated at their respective carrying values, which approximate their fair values. F-8 HOLLIS-EDEN PHARMACEUTICALS, INC. (A Development Stage Company) NOTES TO FINANCIAL STATEMENTS--(Continued) Use of estimates The preparation of financial statements in conformity with generally accepted accounting principles requires management to make estimates and assumptions that affect the reported amounts of assets and liabilities and disclosure of contingent assets and liabilities at the date of the financial statements and the reported amounts of revenues and expenses during the reporting period. Actual results could differ from those estimates. Net loss per share Net loss per share is presented as basic earnings based upon the weighted average number of common shares. Diluted earnings per share have not been presented as the common stock equivalents and their effect on earnings per share is anti-dilutive. Recent accounting pronouncements In June 1998, the FASB issued SFAS No. 133, "Accounting for Derivative Instruments and Hedging Activities." SFAS No. 133 requires companies to recognize all derivative contracts at their fair values, as either assets or liabilities on the balance sheet. If certain conditions are met, a derivative may be specifically designated as a hedge, the objective of which is to match the timing of gain or loss recognition on the hedged derivative with the recognition of (1) the changes in the fair value of the hedged asset or liability that are attributable to the hedged risk, or (2) the earnings effect of the hedged forecasted transaction. For a derivative not designated as a hedging instrument, the gain or loss is recognized as income in the period of change. SFAS No. 133 is effective for all fiscal quarters of fiscal years beginning after June 15, 2000. Historically the Company has not entered into derivative contracts either to hedge existing risks or for speculative purposes. The adoption of this new standard did not have a material effect on the financial statements. 3. Recapitalization On March 26, 1997, Hollis-Eden Inc. was merged (the "Merger") with and into the Company (then known as Initial Acquisition Corp. (IAC)). Upon consummation of the Merger, Hollis-Eden Inc. ceased to exist, and IAC changed its name to Hollis-Eden Pharmaceuticals, Inc. IAC (now called Hollis-Eden Pharmaceuticals, Inc.) remains the continuing legal entity and registrant for Securities and Exchange Commission reporting purposes. The Merger was intended to be a tax- free reorganization for federal income tax purposes and was accounted for as a recapitalization of Hollis-Eden Inc. by an exchange of Common Stock of Hollis- Eden Inc., for the net assets of IAC, consisting primarily of cash. Under the terms of the Merger agreement, each share of Hollis-Eden Inc. Common Stock outstanding immediately prior to the closing of the Merger converted into one share of Common Stock of Hollis-Eden Pharmaceuticals, Inc. Common Stock ("Company Common Stock"), and all warrants and options to purchase Hollis-Eden Inc. Common Stock outstanding immediately prior to the Merger converted into the right to receive the same number of shares of Company Common Stock. For accounting and financial reporting purposes, the Merger was treated as a recapitalization of Hollis-Eden. Since IAC had no business operations other than the search for a suitable target business, IAC's assets were recorded in the balance sheet of the Company at book value. Upon the consummation of the Merger, the Company had $6.5 million in cash and other receivables, and incurred transaction costs of approximately $230,000 associated with the Merger for net proceeds totaling $6.3 million which was recorded as equity. Upon the consummation of the Merger, pursuant to an agreement, the Company issued warrants to purchase an aggregate of 50,000 shares of Company Common Stock at an exercise price of $0.10 per share to a director and former officer. Additional paid-in capital was increased by $570,000 with an offsetting $570,000 charge recorded to operations during the three months ended March 31, 1997. F-9 HOLLIS-EDEN PHARMACEUTICALS, INC. (A Development Stage Company) NOTES TO FINANCIAL STATEMENTS--(Continued) The Company's 1997 Stock Incentive Stock Option Plan became effective on February 5, 1997 and was approved by the stockholders on March 26, 1997. A total of 2,750,000 shares of Company Common Stock have been authorized for issuance under the plan (see Note 12). 4. Financing During January 1999, the Company completed two private placements of an aggregate of 1,367,868 shares of Common Stock at prices ranging from $18.00 to $18.50 per share. In connection with the private placements, the Company issued warrants to purchase an aggregate of 90,000 shares of the Company's Common Stock, with an exercise price of $18.25 per share, as a finder's fee. The Company raised approximately $25.0 million in gross proceeds. 5. Note Receivable from Related Party On May 22, 1998, the Company entered into a promissory note with a stockholder/officer in the amount of $200,000. Interest is at 5.5% per annum. The note is due and payable in full on May 22, 2003. 6. Income Taxes The Company has available a net operating loss carryforward of approximately $35 million at December 31, 2000 which may be carried forward as an offset to taxable income, if any, in future years through its expiration in 2012 to 2020. The Company has a net deferred tax asset of approximately $13 million at December 31, 2000 comprised of capitalized start-up costs, research and development credits, and the net operating loss carryforward. The net deferred tax asset has been fully reserved due to the uncertainty of the Company being able to generate net operating income under the more likely than not criteria of SFAS 109. If certain substantial changes in the Company's ownership should occur, there would potentially be an annual limitation on the amount of the carryforwards, which could be utilized in a tax year. 7. Reverse Stock Splits In March 1996, a 1 for 2.65 split of the Company's common stock was effected. Also, on February 13, 1995 there was a 3 for 5 split of the Company's common stock. All stock splits have been retroactively restated for all periods presented. 8. Related Party Licenses and other Agreements and Commitments and Contingencies Colthurst, Edenland and Mr. Prendergast During 1994, the Company entered into two license agreements and one research, development and option agreement as discussed in the following paragraphs. Pursuant to a license agreement dated May 18, 1994 ("Colthurst License Agreement") with related parties Patrick T. Prendergast, a significant stockholder at the time, and with Colthurst Limited, a company controlled by Mr. Prendergast, the Company acquired the exclusive worldwide rights of Mr. Prendergast's patent rights, know-how and background technology relating to the treatment of human/animal immunodeficiency. The agreement was amended on August 11, 1995 to change the license fee payment terms as discussed below in paragraph four of this Note. Per the license agreement, the Company agreed to pay royalties on product revenues. F-10 HOLLIS-EDEN PHARMACEUTICALS, INC. (A Development Stage Company) NOTES TO FINANCIAL STATEMENTS--(Continued) On August 25, 1994, the Company entered into a license agreement ("Edenland License Agreement") with a related party, Edenland Inc., a company controlled by Mr. Prendergast, for the exclusive worldwide rights of Mr. Prendergast's patent rights, know-how and background technology related to the substance tradenamed HE317 and to any other pharmaceutical product that became subject to the license agreement under the research, development and option agreement discussed below. The agreement was amended on August 11, 1995 to change the license fee payment terms as discussed in the following paragraph. Per the Edenland License Agreement, the Company agreed to pay royalties on product revenues. Effective August 11, 1995, Edenland, Inc., Colthurst Limited and the Company entered into amendments concerning the license fee payment terms to the two agreements described above. Under this amendment, the Company agreed to pay a license fee by April 28, 1996 plus additional license fees within 24 months of April, 1996. The balances of these fees were paid in full by May 1997. As consideration for entering into certain amendments, the Company issued 75,472 shares of the Company's common stock to Edenland, Inc. and Colthurst Limited. Per the amended Colthurst License Agreement, a renewal annual license fee was payable commencing May 1998. The Company paid this fee in 1998 by issuing shares of its common stock and, in 1999, paid in cash. In August 1994, the Company entered into a Research, Development and Option Agreement, with Edenland, Inc. and Mr. Prendergast. The agreement provided for the development of HE317 to a certain stage of development and granted the Company the right of first option on new products developed by Edenland, Inc. The agreement committed the Company to pay for certain development costs up to the amount of $3.0 million with certain contingencies for funding. In October 1996, the Company and Edenland, Inc. entered into an amendment to the existing Research, Development and Option Agreement. This amendment accelerated the date that the $3.0 million payment for HE317 or other product development costs was to be made. A payment of $1.5 million was payable upon the closing of the Merger with IAC and the balance was contingent upon future funding events. $2.7 million of the $3.0 million was paid in 1997, with the remaining $300,000 accrued as an expense in 1997 and paid in April 1998. During November 1999, the Company filed two separate requests for arbitration with Mr. Prendergast, Colthurst and Edenland. The first arbitration sought clarification of certain operational issues with respect to roles and responsibilities set forth in the license agreement covering HE2000. The second arbitration sought to rescind both of the agreements with Edenland covering future potential drug candidates other than HE2000. On January 20, 2000, Hollis-Eden reached a settlement on its pending arbitrations with Mr. Prendergast, Colthurst and Edenland. The Settlement and Mutual Release Agreement completely disposed of all of the matters that were at issue in the pending arbitrations. In addition, the parties entered into two new technology agreements, the Technology Assignment Agreement and the Sponsored Research and License Agreement. The Technology Assignment Agreement replaces the Colthurst License Agreement. Pursuant to the Technology Assignment Agreement, Mr. Prendergast and Colthurst assigned to Hollis-Eden ownership of all patents, patent applications and current or future improvements of the technology under the Colthurst License Agreement, including HE2000, Hollis-Eden's lead clinical compound. The annual license fee of $500,000 and the royalty obligations under the Colthurst License Agreement have been eliminated. In consideration for the foregoing, Hollis-Eden agreed to issue to Colthurst 660,000 shares of Common Stock and a warrant to purchase an aggregate of 400,000 shares of Common Stock at $25 per share. Only 132,000 of such shares of Common Stock were issued in 2000, with the remaining 528,000 shares to be issued over the next four years conditioned F-11 HOLLIS-EDEN PHARMACEUTICALS, INC. (A Development Stage Company) NOTES TO FINANCIAL STATEMENTS--(Continued) on continued compliance with the agreement and, in particular, satisfaction of the Conditions (as defined below). In addition, all of the shares under the warrant vest over four years conditioned on continued compliance with the agreement and, in particular, satisfaction of the Conditions (as defined below). The Sponsored Research and License Agreement replaces the Edenland License Agreement and the Research, Development and Option Agreement. Pursuant to the Sponsored Research and License Agreement, Edenland exclusively licensed to Hollis-Eden a number of compounds, together with all related patents and patent applications, and Hollis-Eden agreed to fund additional preclinical research projects conducted by Edenland. Hollis-Eden will also have exclusive license rights to all results of such research and will have royalty obligations to Edenland on sales of new products, if any, resulting from such research. As stated above, the issuance of the additional shares of Common Stock and the vesting of the warrant is dependent upon the satisfaction of certain conditions (the "Conditions"), including (i) support of Hollis-Eden's actions by Mr. Prendergast and Colthurst, by voting their shares of Hollis-Eden stock in favor of management and (ii) Mr. Prendergast and his affiliated companies not conducting research and development activities relating to the transferred technology. In accordance with Emerging Issues Task Force No. 96-18, Accounting for Equity Instruments That Are Issued to Other Than Employees for Acquiring, or in Conjunction with Selling, Goods or Services, these future events could not be determined at the date of the agreements (January 2000). Accordingly, the shares and warrants will be accounted for as they vest or are issued. During 2000, we recorded a research and development charge for $1.9 million representing the fair value of the 132,000 shares issued under the agreement. Because all of the Conditions have not been satisfied, Hollis-Eden believes it has no obligation to issue to Colthurst any additional shares and that the warrant will not vest as to any shares of Common Stock. While Hollis-Eden is confident in its analysis, if any dispute should arise in this matter, Hollis- Eden cannot guarantee that, as a result of such dispute, additional equity will not be issued or that an additional accounting charge will not be made. Aeson Therapeutics In October 2000, the Company acquired a 21% equity stake in Aeson Therapeutics Inc. ("Aeson") for approximately $4 million and an exclusive worldwide sublicense to three issued patents in the area of adrenal steroids in exchange for $2.0 million in cash and 208,672 shares of Common Stock valued at $2 million. The cash and shares were expensed as in-process R&D during the fourth quarter of 2000. As part of the transaction, Aeson and its shareholders have granted the Company an exclusive option to acquire the remainder of Aeson at a predetermined price. If the Company elects to not exercise the option by April 11, 2002, the Company, at its option, can fund an additional $2.0 million to Aeson for development work and extend the purchase option date until April 11, 2003. Regardless of whether the Company elects to exercise this option, the Company will retain its exclusive sublicense to the three patents. 9. Common Stock Purchase Warrants Series A warrants During April 1996, in accordance with anti-dilution privileges triggered by an offering in March 1995, the Company issued 1,018,866 Series A Warrants to all stockholders of record as of March 1995 to purchase the same number of shares of common stock at a price of $11.02 per share. The warrants are exercisable until January 7, 2002, except for one warrant for 393,250 shares which expires January 7, 2006. F-12 HOLLIS-EDEN PHARMACEUTICALS, INC. (A Development Stage Company) NOTES TO FINANCIAL STATEMENTS--(Continued) Series B warrants During February 1995, the Company issued 37,736 Series B Warrants to Edenland, Inc. in consideration for an amendment to the Edenland License Agreement. The warrants were exercisable until February 5, 2000, to purchase the same number of shares of common stock at a price of $15.90 per share. These warrants have expired. Placement agent warrants During May 1996, the Company issued to the placement agent, for the completion of the private placement in April 1996 (see Note 10), a warrant to purchase an aggregate of up to 445,000 shares of common stock, at an exercise price of $2.475 per share. The fair value of the 445,000 options was deducted from the net proceeds of the private placement as a cost of raising capital and totaled approximately $133,000. Upon the successful closure of the Merger and Redemption of the Class A Common Stock Purchase Warrants and Class B Unit Purchase Warrants, the Company issued additional placement agent warrants to purchase 452,830 shares of common stock at an exercise price of $2.475 per share. These warrants have expired. IAC Management Warrants During April 1994, the Company issued warrants, to existing shareholders and management, to purchase 160,000 units (the "Units") at $10.00 per Unit, each unit to be identical to the Units issued as part of its initial public offering. The warrants were exercisable until May 15, 2000 except for one warrant to purchase 50,000 units which expires May 15, 2002. Each Unit consists of (i) one share of common stock, $.01 par value per share and (ii) one Class A Warrants entitling the holder to purchase one share of common stock at a price of $9.00 per share. The unexercised warrants with an expiration date of May 15, 2000 have expired. Representatives warrants In connection with the Company's initial public offering, the Company issued warrants to the underwriters for 60,000 Units at an exercise price of $11.00 per Unit and 24 Class B Warrants at an exercise price of $5.775 per warrant and were exercisable until May 15, 2000. Each Class B Warrant entitled the holder to purchase one Unit (i.e. one share of common stock and one Class A Warrant). The unexercised warrants have expired. Investor Relations Warrants During February 1998, as part of payment for investor relations, the Company issued 150,000 warrants with an exercise price of $14.75 per share and an expiration date of February 4, 1999. The warrants were estimated to have a value of $408,000 which was expensed in 1998. These warrants have been exercised. 1998 Private Placement Warrants In connection with the May 1998 private placement, the Company issued warrants to purchase 1,437,475 shares of common stock at an exercise price of $17.00 per share. The warrants are exercisable until May 6, 2001. Of the warrants issued, 157,000 were issued as finder fees, and 1,280,475 were issued to the private placement investors. 1999 Agent Warrants In connection with the January 1999, private placement, the Company issued warrants to purchase 90,000 shares of common stock as a finders fee. The warrants are exercisable until January 22, 2002 at an exercise price of $18.25 per share. F-13 HOLLIS-EDEN PHARMACEUTICALS, INC. (A Development Stage Company) NOTES TO FINANCIAL STATEMENTS--(Continued) 1999 Consulting Warrants During March 1999, the Company entered into a three-year agreement with a financial consulting organization affiliated with a director of the Company. The Company agreed to issue as compensation for services, warrants to purchase 500,000 shares of Common Stock with an exercise price of $20.50 per share and an expiration date of March 2002. The warrants are not subject to any vesting provisions. The warrants were estimated to have a value of approximately $2.1 million, which was expensed as a non-cash charge during the first quarter of 1999. The following table summarizes stock warrant activity for 1998 through 2000 (in thousands, except per share amounts):
Price Per Share ----------------------- Weighted Shares Range Average ------ -------------- -------- Outstanding, December 31, 1997................... 2,373 $ 2.48 - 15.90 $ 7.79 1998 Issued........................................... 1,587 14.75 - 17.00 16.79 Exercised........................................ 398 2.48 - 10.00 3.01 Outstanding, December 31, 1998................... 3,562 2.48 - 17.00 12.33 1999 Issued........................................... 590 18.25 - 20.50 20.16 Exercised........................................ 755 2.48 - 14.75 6.88 Canceled......................................... 7 11.02 11.02 Outstanding, December 31, 1999................... 3,390 2.48 - 20.50 14.91 2000 Issued........................................... 400 25.00 25.00 Exercised........................................ 133 2.48 - 9.50 5.71 Canceled......................................... 123 6.03 - 15.90 11.51 Outstanding, December 31, 2000................... 3,534 $ 9.00 - 25.00 $16.52
For various price ranges, the following table summarizes the weighted average prices of outstanding warrants as of December 31, 2000 (in thousands, except per share amounts):
Outstanding Warrants Exercisable Warrants ------------------------------ ------------------------------ Weighted Weighted Range of average average Exercise Prices Shares price Shares price --------------- ------ -------- ------ -------- $ 5.01 - $10.00 100 $ 9.50 100 $ 9.50 $10.01 - $15.00 1,007 11.02 1,007 11.02 $15.01 - $20.00 1,527 17.07 1,527 17.07 $20.01 - $25.00 900 22.50 500 20.50
10. Common Stock On January 21, 1996, the Company completed a $367,522 round of debt financing with a group of private investors. These notes, with an 8% interest rate, were due on or before the earlier of (i) January 21, 1997 or (ii) the closing of a private or public offering of securities. The Company had the option to repay these notes with common stock of the Company. Proceeds from this debt financing were used to repay the note and accounts F-14 HOLLIS-EDEN PHARMACEUTICALS, INC. (A Development Stage Company) NOTES TO FINANCIAL STATEMENTS--(Continued) payable to a related party, and accrued interest totaling $371,164. During April 1996, the debt financing, plus accrued interest, were converted into 164,962 shares of common stock at a price of $2.25 per share. During March and April of 1996, the Company privately issued 580,005 shares of the Company's Common Stock at an offering price of $2.25 per share. Total proceeds from this offering aggregated $1,234,499. During May 1998, the Company completed a private financing totaling $20.6 million in gross proceeds. The Company issued 1,329,201 shares of Common Stock, (of which 192,061 shares were subject to adjustment based on future average stock price ("Adjustable Common Stock")), 4,000 shares of 5% Series A Convertible Preferred Stock and Warrants to purchase 1,437,475 shares of Common Stock in the financing. The Warrants are exercisable for three years and entitle the holders to purchase up to a total of 1,437,475 shares of Common Stock at a price of $17.00 per share. The Convertible Preferred Stock had an initial conversion price of $20.30 for the first seven months, after which it could be adjusted, either up or down, based on the future stock prices of the Company's Common Stock. The Convertible Preferred Stock was converted to Common Stock in January 1999 (See Note 11). 11. Preferred Stock During May 1998, as part of the private placement, the Company issued 4,000 shares of Convertible Preferred Stock for proceeds of $4.0 million. During January 1999, the Company issued 346,127 shares of Common Stock in connection with the conversion of the Series A Convertible Preferred Stock and additional shares relating to the Adjustable Common Stock. The Adjustable Common Stock was issued during the private placement of May 1998 and was subject to adjustment based on the future average stock price of the Company's Common Stock as described in Note 10. Upon conversion, all outstanding Preferred shares and Adjustable Common shares were eliminated. In November 1999, the Company adopted a Shareholders Rights Plan in which Preferred Stock purchase rights ("Rights") were distributed as a dividend at the rate of one Right for each share of common stock held as of the close of business on November 29, 1999. Each right entitles stockholders to buy, upon certain events, one one-hundredth of a share of a new Series B junior participating preferred stock of the Company at an exercise price of $100.00. The Rights are designed to guard against partial tender offers and other abusive tactics that might be used in an attempt to gain control of the Company or to deprive stockholders of their interest in the long-term value of the Company. The Rights are exercisable only if a person or group acquires 15% or more of the Company's common stock or announces a tender offer of which the consummation would result in ownership by a person or group of 15% or more of the Company's common stock. The Rights are redeemable for one cent per Right at the option of the Board of Directors prior to this event occurring. The Rights expire on November 14, 2009. F-15 HOLLIS-EDEN PHARMACEUTICALS, INC. (A Development Stage Company) NOTES TO FINANCIAL STATEMENTS--(Continued) 12. Stock Options The 1997 Stock Option Plan (the "Plan") was approved by the shareholders in 1997. Under the Plan, 2,750,000 shares of common stock have been reserved for issuance to employees, officers, directors, and consultants of the Company and provides for the grant of incentive and nonstatutory stock options. Terms of the stock option agreements, including vesting requirements, are determined by the Board of Directors. The exercise price of incentive stock options must equal at least the fair market value on the date of grant. The options expire not later than ten years from the date of the grant and become exercisable immediately or generally are exercisable ratably over a three-year or four year period beginning one year from the date of the grant. The following table summarizes stock option activity under the Plan for 1997 through 2000 (in thousands, except per share amounts):
Price Per Share ----------------------- Weighted Shares Range Average ------ -------------- -------- 1997 Granted.......................................... 518 $ 6.25 - 8.70 $ 7.13 Outstanding, December 31, 1997................... 518 6.75 - 8.70 7.13 1998 Granted.......................................... 341 13.25 - 16.75 14.52 Canceled......................................... 100 8.70 8.70 Outstanding, December 31, 1998................... 759 6.75 - 16.75 10.24 1999 Granted.......................................... 776 10.56 - 16.63 12.70 Canceled......................................... 61 14.06 - 14.63 14.63 Outstanding, December 31, 1999................... 1,474 6.75 - 16.75 11.36 2000 Granted.......................................... 774 6.50 - 15.06 8.18 Exercised........................................ 1 6.75 6.75 Canceled......................................... 24 6.75 - 15.13 14.22 Outstanding, December 31, 2000................... 2,223 $ 6.50 - 16.75 $10.22
The Company entered into stock option agreements outside of the Plan with certain directors, officers and consultants. These options become exercisable according to a schedule of vesting as determined by the Board of Directors. During 1998, 1999 and 2000, the Company granted options to certain consultants and directors, and will recognize $540,000, $380,000 and $166,000 in expense related to these options ratably over the three-year vesting period. $240,000, $559,000 and $79,000 were expensed in 1998, 1999 and 2000 respectively. In February 1997, as part of an employment agreement, the Company granted a non-statutory stock option to an executive to purchase 2,400,000 shares of the Company's common stock at a price of $5.00 per share, which option vested ratably over a six-year period. The intrinsic value of the options was $1,848,000. As a result, the Company recorded as deferred compensation a non- cash charge of $1,848,000, which was being amortized ratably over the six-year vesting period. Through February 28, 1999 the Company had amortized a total of $641,333. On March 1, 1999, the Company announced the resignation of this executive. Concurrent therewith, the Company accelerated the vesting of 300,000 stock options previously granted to the executive. This acceleration is considered to be a new grant of options and, as such, the Company took a one-time non-cash charge of $4.9 million during the first quarter of 1999. F-16 HOLLIS-EDEN PHARMACEUTICALS, INC. (A Development Stage Company) NOTES TO FINANCIAL STATEMENTS--(Continued) The following table summarizes stock option activity not pursuant to the Plan for 1995 through 2000 (in thousands, except per share amounts):
Price Per Share ---------------------- Weighted Shares Range Average ------ ------------- -------- 1995 Granted........................................... 38 $ 2.65 - 7.95 $ 4.64 Outstanding, December 31, 1995.................... 38 2.65 - 7.95 4.64 1996 Granted........................................... 570 2.25 2.25 Outstanding, December 31, 1996.................... 608 2.25 - 7.95 2.40 1997 Granted........................................... 2,400 5.00 5.00 Canceled.......................................... 50 2.25 2.25 Outstanding, December 31, 1997.................... 2,958 2.25 - 7.95 4.51 1998 Exercised......................................... 53 2.25 - 5.30 2.93 Canceled.......................................... 50 2.25 2.25 Outstanding, December 31, 1998.................... 2,855 2.25 - 7.95 4.58 1999 Granted........................................... 300 16.63 16.63 Exercised......................................... 10 7.95 7.95 Canceled.......................................... 1,220 2.25 - 5.00 4.95 Outstanding, December 31, 1999.................... 1,925 2.25 - 16.63 6.16 Outstanding, December 31, 2000.................... 1,925 $2.25 - 16.63 $ 6.16
For various price ranges, weighted average characteristics of outstanding stock options at December 31, 2000 were as follows:
Exercisable options Outstanding options --------------------- ------------------------------------ Weighted Weighted Range of Remaining average average Exercise Prices Shares life (years) price Shares price --------------- --------- ------------ -------- --------- -------- $ 2.25 - $ 4.99 425,000 5.3 $ 2.25 425,000 $ 2.25 $ 5.00 - $ 8.99 2,158,366 8.3 5.72 1,183,667 5.62 $ 9.00 - $12.99 570,165 9.0 10.78 150,564 10.56 $13.00 - $16.99 994,800 8.1 15.31 622,325 15.32
Statement of Financial Accounting Standards No. 123 ("SFAS 123") During 1995, the Financial Accounting Standards Board issued SFAS 123, Accounting for Stock-Based Compensation, which defines a fair-value-based method of accounting for stock compensation plans. However, it also allows an entity to continue to measure compensation cost related to stock compensation plans using the method of accounting prescribed by the Accounting Principles Board Opinion No. 25 (APB 25), Accounting for Stock Issued to Employees. Entities electing to follow APB 25 must make pro forma disclosures of net income, as if the fair-value-based method of accounting defined in SFAS had been applied. F-17 HOLLIS-EDEN PHARMACEUTICALS, INC. (A Development Stage Company) NOTES TO FINANCIAL STATEMENTS--(Continued) The Company has elected to account for its stock-based compensation plans under APB 25; however, for pro forma disclosure purposes, the Company has computed the value of all options granted to employees during 1998 through 2000, using the Black-Scholes option pricing model with the following weighted average assumptions:
2000 1999 1998 ------- ------- ------- Risk free interest rate........................... 5.45% 5.31% 5.55% Expected dividend yield........................... 0% 0% 0% Expected lives.................................... 5 years 5 years 5 years Expected volatility............................... 137% 46.5% 46.5%
The stock options were assumed to be exercised in five to seven years. Adjustments are made for options forfeited prior to vesting. The total value of warrants and options was computed to be the following approximate amounts, which would be amortized on the straight-line basis over the vesting period of the options (in thousands): Year ended December 31, 1998......................................... $1,436 Year ended December 31, 1999......................................... $6,662 Year ended December 31, 2000......................................... $5,104
If the Company had accounted for stock options issued to employees and directors in accordance with SFAS 123, the Company's net loss would have been reported as follows (in thousands): Net loss
Year ended December 31, ---------------------- 2000 1999 1998 ------- ------- ------ As reported........................................... $19,515 $15,320 $5,427 Pro forma............................................. $24,619 $21,982 $6,863
The Black-Scholes option valuation model was developed for use in estimating the fair value of traded options that have no vesting restrictions and are fully transferable. In addition, option valuation models require the input of highly subjective assumptions including the expected stock price volatility. Because the Company's employee stock options have characteristics significantly different from those of traded options, and because changes in subjective input assumptions can materially affect the fair value estimate, in management's opinion, the existing models do not necessarily provide a reliable single measure of the fair value of the Company's options. The weighted average, estimated fair values of employee stock options granted during fiscal 2000, 1999 and 1998 were $6.59, $8.59 and $4.21 per share, respectively. 13. Employment Agreement Pursuant to an employment agreement between Hollis-Eden and Mr. Richard B. Hollis entered into in November 1996 (the "Hollis Employment Agreement"), Mr. Hollis' annual base salary was increased to $225,000 upon the consummation of the Merger, with bonuses, future salary increases and equity compensation as determined by the Hollis-Eden Pharmaceuticals Board of Directors. On January 1, 2000, Mr. Hollis' base salary was increased from $330,000 to $363,000. If Mr. Hollis' employment is terminated "without cause," "for insufficient reason" or pursuant to a "change in control" (as such terms are defined in the Hollis Employment Agreement), Mr. Hollis will receive as severance (i) an amount equal to five times his then current annual base salary plus five times the amount of the bonus awarded to him in the prior calendar year, (ii) immediate vesting of all unvested stock options of Hollis-Eden Pharmaceuticals (or the Surviving Corporation, if applicable) held by him and (iii) continued benefits under all employee benefit plans and programs for a period of three years. F-18 HOLLIS-EDEN PHARMACEUTICALS, INC. (A Development Stage Company) NOTES TO FINANCIAL STATEMENTS--(Continued) All of such payments are to be made in one lump sum within 30 days of termination. If Mr. Hollis' employment is terminated "with cause" or if Mr. Hollis resigns other than for "sufficient reason," Mr. Hollis' compensation and benefits will cease immediately and Mr. Hollis will not be entitled to severance benefits. 14. Leases Rental expenses for principally leased facilities under operating leases were approximately $431,000, $315,000 and $115,000 for 2000, 1999 and 1998, respectively. Future minimum payments for operating leases are as follows (in thousands):
Operating Leases --------- 2001............................................................ $456 2002............................................................ 320 2003............................................................ 24 2004............................................................ 10 2005............................................................ 0 ---- Total minimum lease payments.................................... $810 ====
15. Selected Quarterly Financial Information (Unaudited) A summary of quarterly financial information for each of the last two years follows:
Quarter ------------------------------------ Total March June September December Year ------- ------- --------- -------- ------- (In thousands, except per share) YEAR ENDED DECEMBER 31, 2000 R&D expenses.................... $ 4,198 $ 2,617 $ 2,147 $ 4,445 $13,407 G&A expenses.................... 1,077 1,025 771 1,284 4,157 Non-cash charges (1)............ 2,454 24 24 2,024 4,526 Net loss........................ 7,085 2,993 2,279 7,158 19,515 Net loss per share.............. (0.63) (0.27) (0.20) (0.64) (1.74) Cash and cash equivalents....... 45,044 41,140 38,776 34,298 34,298 YEAR ENDED DECEMBER 31, 1999 R&D expenses.................... $ 759 $ 1,601 $ 1,406 $ 1,965 $ 5,731 G&A expenses.................... 966 1,127 791 1,395 4,279 Non-cash charges (2)............ 7,166 148 165 182 7,661 Net loss........................ 8,393 2,277 1,754 2,896 15,320 Net loss per share.............. (0.92) (0.21) (0.16) (0.26) (1.41) Cash and cash equivalents....... 52,870 50,592 49,086 47,486 47,486
- - -------- (1) Non-cash charges during 2000 was for the purchase of technology and the licensing of technology during the first quarter and the purchase of in- process research and development during the fourth quarter. (2) Non-cash charged during the first quarter of 1999 was for the acceleration of vesting of options for a former officer of Hollis-Eden and for warrants issued with a financial consulting organization affiliated with a director of Hollis-Eden. F-19
EX-10.14 2 0002.txt INDEMNIFICATION AGREEMENT Exhibit 10.14 HOLLIS-EDEN PHARMACEUTICALS, INC. INDEMNIFICATION AGREEMENT This Indemnification Agreement ("Agreement") is effective as of _______________, by and between Hollis-Eden Pharmaceuticals, Inc., a Delaware corporation (the "Company"), and _____________________________ ("Indemnitee"). WHEREAS, the Company desires to attract and retain the services of highly qualified individuals, such as Indemnitee, to serve the Company and its related entities; WHEREAS, in order to induce Indemnitee to continue to provide services to the Company, the Company wishes to provide for the indemnification of, and the advancement of expenses to, Indemnitee to the maximum extent permitted by law; WHEREAS, the Company and Indemnitee recognize the continued difficulty in obtaining liability insurance for the Company's directors, officers, employees, agents and fiduciaries, the significant increases in the cost of such insurance and the general reductions in the coverage of such insurance; WHEREAS, the Company and Indemnitee further recognize the substantial increase in corporate litigation in general, subjecting directors, officers, employees, agents and fiduciaries to expensive litigation risks at the same time as the availability and coverage of liability insurance has been severely limited; and WHEREAS, in view of the considerations set forth above, the Company desires that Indemnitee shall be indemnified and advanced expenses by the Company as set forth herein; NOW, THEREFORE, the Company and Indemnitee hereby agree as set forth below. 1. Certain Definitions. ------------------- (a) "Change in Control" shall mean, and shall be deemed to have occurred if, on or after the date of this Agreement, (i) any "person" (as such term is used in Sections 13(d) and 14(d) of the Securities Exchange Act of 1934, as amended), other than a trustee or other fiduciary holding securities under an employee benefit plan of the Company acting in such capacity or a corporation owned directly or indirectly by the stockholders of the Company in substantially the same proportions as their ownership of stock of the Company, becomes the "beneficial owner" (as defined in Rule 13d-3 under said Act), directly or indirectly, of securities of the Company representing more than 50% of the total voting power represented by the Company's then outstanding Voting Securities, (ii) during any period of two consecutive years, individuals who at the beginning of such period constitute the Board of Directors of the Company and any new director whose election by the Board of Directors or nomination for election by the Company's stockholders was approved by a vote of at least two thirds (2/3) of the directors then still in office who either were directors at the beginning of the period or whose election or nomination for election was previously so approved, cease for any reason to constitute a majority thereof, or (iii) the stockholders of the Company approve a merger or consolidation of the Company with any other corporation other than a merger or consolidation which would result in the Voting Securities of the Company outstanding immediately prior thereto continuing to represent (either by remaining outstanding or by being converted into Voting Securities of the surviving entity) at least 80% of the total voting power represented by the Voting Securities of the Company or such surviving entity outstanding immediately after such merger or consolidation, or the stockholders of the Company approve a plan of complete liquidation of the Company or an agreement for the sale or disposition by the Company of (in one transaction or a series of related transactions) all or substantially all of the Company's assets. (b) "Claim" shall mean with respect to a Covered Event: any threatened, pending or completed action, suit, proceeding or alternative dispute resolution mechanism, or any hearing, inquiry or investigation that Indemnitee in good faith believes might lead to the institution of any such action, suit, proceeding or alternative dispute resolution mechanism, whether civil, criminal, administrative, investigative or other. (c) References to the "Company" shall include, in addition to Hollis- Eden Pharmaceuticals, Inc., any constituent corporation (including any constituent of a constituent) absorbed in a consolidation or merger to which Hollis-Eden Pharmaceuticals, Inc. (or any of its wholly owned subsidiaries) is a party which, if its separate existence had continued, would have had power and authority to indemnify its directors, officers, employees, agents or fiduciaries, so that if Indemnitee is or was a director, officer, employee, agent or fiduciary of such constituent corporation, or is or was serving at the request of such constituent corporation as a director, officer, employee, agent or fiduciary of another corporation, partnership, joint venture, employee benefit plan, trust or other enterprise, Indemnitee shall stand in the same position under the provisions of this Agreement with respect to the resulting or surviving corporation as Indemnitee would have with respect to such constituent corporation if its separate existence had continued. (d) "Covered Event" shall mean any event or occurrence related to the fact that Indemnitee is or was a director, officer, employee, agent or fiduciary of the Company, or any subsidiary of the Company, or is or was serving at the request of the Company as a director, officer, employee, agent or fiduciary of another corporation, partnership, joint venture, trust or other enterprise, or by reason of any action or inaction on the part of Indemnitee while serving in such capacity. (e) "Expenses" shall mean any and all expenses (including attorneys' fees and all other costs, expenses and obligations incurred in connection with investigating, defending, being a witness in or participating in (including on appeal), or preparing to defend, to be a witness in or to participate in, any action, suit, proceeding, alternative dispute resolution mechanism, hearing, inquiry or investigation), judgments, fines, penalties and amounts paid in settlement (if such settlement is approved in advance by the Company, which approval shall not be unreasonably withheld), actually and reasonably incurred, of any Claim and any federal, state, local or foreign taxes imposed on the Indemnitee as a result of the actual or deemed receipt of any payments under this Agreement. 2 (f) "Expense Advance" shall mean a payment to Indemnitee pursuant to Section 3 of Expenses in advance of the settlement of or final judgment in any action, suit, proceeding or alternative dispute resolution mechanism, hearing, inquiry or investigation which constitutes a Claim. (g) "Independent Legal Counsel" shall mean an attorney or firm of attorneys, selected in accordance with the provisions of Section 2(d) hereof, who shall not have otherwise performed services for the Company or Indemnitee within the last three years (other than with respect to matters concerning the rights of Indemnitee under this Agreement, or of other indemnitees under similar indemnity agreements). (h) References to "other enterprises" shall include employee benefit plans; references to "fines" shall include any excise taxes assessed on Indemnitee with respect to an employee benefit plan; and references to "serving at the request of the Company" shall include any service as a director, officer, employee, agent or fiduciary of the Company which imposes duties on, or involves services by, such director, officer, employee, agent or fiduciary with respect to an employee benefit plan, its participants or its beneficiaries; and if Indemnitee acted in good faith and in a manner Indemnitee reasonably believed to be in the interest of the participants and beneficiaries of an employee benefit plan, Indemnitee shall be deemed to have acted in a manner "not opposed to the best interests of the Company" as referred to in this Agreement. (i) "Reviewing Party" shall mean, subject to the provisions of Section 2(d), any person or body appointed by the Board of Directors in accordance with applicable law to review the Company's obligations hereunder and under applicable law, which may include a member or members of the Company's Board of Directors, Independent Legal Counsel or any other person or body not a party to the particular Claim for which Indemnitee is seeking indemnification. (j) "Section" refers to a section of this Agreement unless otherwise indicated. (k) "Voting Securities" shall mean any securities of the Company that vote generally in the election of directors. 2. Indemnification. --------------- (a) Indemnification of Expenses. Subject to the provisions of Section --------------------------- 2(b) below, the Company shall indemnify Indemnitee for Expenses to the fullest extent permitted by law if Indemnitee was or is or becomes a party to or witness or other participant in, or is threatened to be made a party to or witness or other participant in, any Claim (whether by reason of or arising in part out of a Covered Event), including all interest, assessments and other charges paid or payable in connection with or in respect of such Expenses. (b) Review of Indemnification Obligations. Notwithstanding the ------------------------------------- foregoing, in the event any Reviewing Party shall have determined (in a written opinion, in any case in which Independent Legal Counsel is the Reviewing Party) that Indemnitee is not entitled to be indemnified hereunder under applicable law, (i) the Company shall have no further obligation under Section 2(a) to make any payments to Indemnitee not made prior to such determination by such Reviewing Party, and (ii) the Company shall be entitled to be reimbursed by Indemnitee (who hereby agrees to reimburse the Company) for all Expenses theretofore paid in indemnifying 3 Indemnitee; provided, however, that if Indemnitee has commenced or thereafter commences legal proceedings in a court of competent jurisdiction to secure a determination that Indemnitee is entitled to be indemnified hereunder under applicable law, any determination made by any Reviewing Party that Indemnitee is not entitled to be indemnified hereunder under applicable law shall not be binding and Indemnitee shall not be required to reimburse the Company for any Expenses theretofore paid in indemnifying Indemnitee until a final judicial determination is made with respect thereto (as to which all rights of appeal therefrom have been exhausted or lapsed). Indemnitee's obligation to reimburse the Company for any Expenses shall be unsecured and no interest shall be charged thereon. (c) Indemnitee Rights on Unfavorable Determination: Binding Effect. -------------------------------------------------------------- If any Reviewing Party determines that Indemnitee substantively is not entitled to be indemnified hereunder in whole or in part under applicable law, Indemnitee shall have the right to commence litigation seeking an initial determination by the court or challenging any such determination by such Reviewing Party or any aspect thereof, including the legal or factual bases therefor, and, subject to the provisions of Section 15, the Company hereby consents to service of process and to appear in any such proceeding. Absent such litigation, any determination by any Reviewing Party shall be conclusive and binding on the Company and Indemnitee. (d) Selection of Reviewing Party: Change in Control. If there has not ----------------------------------------------- been a Change in Control, any Reviewing Party shall be selected by the Board of Directors, and if there has been such a Change in Control (other than a Change in Control which has been approved by a majority of the Company's Board of Directors who were directors immediately prior to such Change in Control), any Reviewing Party with respect to all matters thereafter arising concerning the rights of Indemnitee to indemnification of Expenses under this Agreement or any other agreement or under the Company's Certificate of Incorporation or Bylaws as now or hereafter in effect, or under any other applicable law, if desired by Indemnitee, shall be, Independent Legal Counsel selected by Indemnitee and approved by the Company (which approval shall not be unreasonably withheld). Such counsel, among other things, shall render its written opinion to the Company and Indemnitee as to whether and to what extent Indemnitee would be entitled to be indemnified hereunder under applicable law and the Company agrees to abide by such opinion. The Company agrees to pay the reasonable fees of the Independent Legal Counsel referred to above and to indemnify fully such counsel against any and all expenses (including attorneys' fees), claims, liabilities and damages arising out of or relating to this Agreement or its engagement pursuant hereto. Notwithstanding any other provision of this Agreement, the Company shall not be required to pay Expenses of more than one Independent Legal Counsel in connection with all matters concerning a single Indemnitee, and such Independent Legal Counsel shall be the Independent Legal Counsel for any or all other Indemnitees unless (i) the Company otherwise determines or (ii) any Indemnitee shall provide a written statement setting forth in detail a reasonable objection to such Independent Legal Counsel representing other Indemnitees. (e) Mandatory Payment of Expenses. Notwithstanding any other ----------------------------- provision of this Agreement other than Section 10 hereof, to the extent that Indemnitee has been successful on the merits or otherwise, including, without limitation, the dismissal of an action without prejudice, in defense of any Claim, Indemnitee shall be indemnified against all Expenses incurred by Indemnitee in connection therewith. 3. Expense Advances. ---------------- 4 (a) Obligation to Make Expense Advances. Upon receipt of a written ----------------------------------- undertaking by or on behalf of the Indemnitee to repay such amounts if it shall ultimately be determined that the Indemnitee is not entitled to be indemnified therefor by the Company, the Company shall make Expense Advances to Indemnitee. (b) Form of Undertaking. Any written undertaking by the Indemnitee to ------------------- repay any Expense Advances hereunder shall be unsecured and no interest shall be charged thereon. (c) Determination of Reasonable Expense Advances. The parties agree -------------------------------------------- that for the purposes of any Expense Advance for which Indemnitee has made written demand to the Company in accordance with this Agreement, all Expenses included in such Expense Advance that are certified by affidavit of Indemnitee's counsel as being reasonable shall be presumed conclusively to be reasonable. 4. Procedures for Indemnification and Expense Advances. --------------------------------------------------- (a) Timing of Payments. All payments of Expenses (including without ------------------ limitation Expense Advances) by the Company to the Indemnitee pursuant to this Agreement shall be made to the fullest extent permitted by law as soon as practicable after written demand by Indemnitee therefor is presented to the Company, but in no event later than forty-five (45) business days after such written demand by Indemnitee is presented to the Company, except in the case of Expense Advances, which shall be made no later than twenty (20) business days after such written demand by Indemnitee is presented to the Company. (b) Notice/Cooperation by Indemnitee. Indemnitee shall, as a -------------------------------- condition precedent to Indemnitee's right to be indemnified or Indemnitee's right to receive Expense Advances under this Agreement, give the Company notice in writing as soon as practicable of any Claim made against Indemnitee for which indemnification will or could be sought under this Agreement. Notice to the Company shall be directed to the Chief Executive Officer of the Company at the address shown on the signature page of this Agreement (or such other address as the Company shall designate in writing to Indemnitee). In addition, Indemnitee shall give the Company such information and cooperation as it may reasonably require and as shall be within Indemnitee's power. (c) No Presumptions: Burden of Proof. For purposes of this Agreement, -------------------------------- the termination of any Claim by judgment, order, settlement (whether with or without court approval) or conviction, or upon a plea of nolo contenders, or its equivalent, shall not create a presumption that Indemnitee did not meet any particular standard of conduct or have any particular belief or that a court has determined that indemnification is not permitted by this Agreement or applicable law. In addition, neither the failure of any Reviewing Party to have made a determination as to whether Indemnitee has met any particular standard of conduct or had any particular belief, nor an actual determination by any Reviewing Party that Indemnitee has not met such standard of conduct or did not have such belief, prior to the commencement of legal proceedings by Indemnitee to secure a judicial determination that Indemnitee should be indemnified under this Agreement or applicable law, shall be a defense to Indemnitee's claim or create a presumption that Indemnitee has not met any particular standard of conduct or did not have any particular belief. In connection with any determination by any Reviewing Party or 5 otherwise as to whether the Indemnitee is entitled to be indemnified hereunder, the burden of proof shall be on the Company to establish that Indemnitee is not so entitled. (d) Notice to Insurers. If, at the time of the receipt by the Company ------------------ of a notice of a Claim pursuant to Section 4(b) hereof, the Company has liability insurance in effect which may cover such Claim, the Company shall give prompt notice of the commencement of such Claim to the insurers in accordance with the procedures set forth in the respective policies. The Company shall thereafter take all necessary or desirable action to cause such insurers to pay, on behalf of the Indemnitee, all amounts payable as a result of such Claim in accordance with the terms of such policies. (e) Selection of Counsel. In the event the Company shall be obligated -------------------- hereunder to provide indemnification for or make any Expense Advances with respect to the Expenses of any Claim, the Company, if appropriate, shall be entitled to assume the defense of such Claim with counsel approved by Indemnitee (which approval shall not be unreasonably withheld) upon the delivery to Indemnitee of written notice of the Company's election to do so. After delivery of such notice, approval of such counsel by Indemnitee and the retention of such counsel by the Company, the Company will not be liable to Indemnitee under this Agreement for any fees or expenses of separate counsel subsequently employed by or on behalf of Indemnitee with respect to the same Claim; provided that, (i) Indemnitee shall have the right to employ Indemnitee's separate counsel in any such Claim at Indemnitee's expense and (ii) if (A) the employment of separate counsel by Indemnitee has been previously authorized by the Company, (B) Indemnitee shall have reasonably concluded that there may be a conflict of interest between the Company and Indemnitee in the conduct of any such defense, or (C) the Company shall not continue to retain such counsel to defend such Claim, then the fees and expenses of Indemnitee's separate counsel shall be Expenses for which Indemnitee may receive indemnification or Expense Advances hereunder. 5. Additional Indemnification Rights: Nonexclusivity. ------------------------------------------------- (a) Scope. The Company hereby agrees to indemnify the Indemnitee to ----- the fullest extent permitted by law, notwithstanding that such indemnification is not specifically authorized by the other provisions of this Agreement, the Company's Certificate of Incorporation, the Company's Bylaws or by statute. In the event of any change after the date of this Agreement in any applicable law, statute or rule which expands the right of a Delaware corporation to indemnify a member of its board of directors or an officer, employee, agent or fiduciary, it is the intent of the parties hereto that Indemnitee shall enjoy by this Agreement the greater benefits afforded by such change. In the event of any change in any applicable law, statute or rule which narrows the right of a Delaware corporation to indemnify a member of its board of directors or an officer, employee, agent or fiduciary, such change, to the extent not otherwise required by such law, statute or rule to be applied to this Agreement, shall have no effect on this Agreement or the parties' rights and obligations hereunder except as set forth in Section 10(a) hereof. (b) Nonexclusive. The indemnification and the payment of Expense ------------ Advances provided by this Agreement shall be in addition to any rights to which Indemnitee may be entitled under the Company's Certificate of Incorporation, its Bylaws, any other agreement, any vote of stockholders or disinterested directors, the General Corporation Law of the State of Delaware, or otherwise. The indemnification and the payment of Expense Advances provided under this 6 Agreement shall continue as to Indemnitee for any action taken or not taken while serving in an indemnified capacity even though subsequent thereto Indemnitee may have ceased to serve in such capacity. 6. No Duplication of Payments. The Company shall not be liable under -------------------------- this Agreement to make any payment in connection with any Claim made against Indemnitee to the extent Indemnitee has otherwise actually received payment (under any insurance policy, provision of the Company's Certificate of Incorporation, Bylaws or otherwise) of the amounts otherwise payable hereunder. 7. Partial Indemnification. If Indemnitee is entitled under any ----------------------- provision of this Agreement to indemnification by the Company for some or a portion of Expenses incurred in connection with any Claim, but not, however, for all of the total amount thereof, the Company shall nevertheless indemnify Indemnitee for the portion of such Expenses to which Indemnitee is entitled. 8. Mutual Acknowledgement. Both the Company and Indemnitee acknowledge ---------------------- that in certain instances, federal law or applicable public policy may prohibit the Company from indemnifying its directors, officers, employees, agents or fiduciaries under this Agreement or otherwise. Indemnitee understands and acknowledges that the Company has undertaken or may be required in the future to undertake with the Securities and Exchange Commission to submit the question of indemnification to a court in certain circumstances for a determination of the Company's right under public policy to indemnify Indemnitee. 9. Liability Insurance. To the extent the Company maintains liability ------------------- insurance applicable to directors, officers, employees, agents or fiduciaries, Indemnitee shall be covered by such policies in such a manner as to provide Indemnitee the same rights and benefits as are provided to the most favorably insured of the Company's directors, if Indemnitee is a director; or of the Company's officers, if Indemnitee is not a director of the Company but is an officer; or of the Company's key employees, agents or fiduciaries, if Indemnitee is not an officer or director but is a key employee, agent or fiduciary. 10. Exceptions. Notwithstanding any other provision of this Agreement, ---------- the Company shall not be obligated pursuant to the terms of this Agreement: (a) Excluded Action or Omissions. To indemnify Indemnitee for ---------------------------- Expenses resulting from acts, omissions or transactions for which Indemnitee is prohibited from receiving indemnification under this Agreement or applicable law; provided, however, that notwithstanding any limitation set forth in this Section 10(a) regarding the Company's obligation to provide indemnification, Indemnitee shall be entitled under Section 3 to receive Expense Advances hereunder with respect to-any such Claim unless and until a court having jurisdiction over the Claim shall have made a final judicial determination (as to which all rights of appeal therefrom have been exhausted or lapsed) that indemnitee has engaged in acts, omissions or transactions for which Indemnitee is prohibited from receiving indemnification under this Agreement or applicable law. (b) Claims Initiated by Indemnitee. To indemnify or make Expense ------------------------------ Advances to Indemnitee with respect to Claims initiated or brought voluntarily by Indemnitee and not by way of defense, counterclaim or cross-claim, except (i) with respect to actions or proceedings 7 brought to establish or enforce a right to indemnification under this Agreement or any other agreement or insurance policy or under the Company's Certificate of Incorporation or Bylaws now or hereafter in effect relating to Claims for Covered Events, (ii) in specific cases if the Board of Directors has approved the initiation or bringing of such Claim, or (iii) as otherwise required under Section 145 of the Delaware General Corporation Law, regardless of whether Indemnitee ultimately is determined to be entitled to such indemnification or insurance recovery, as the case may be. (c) Lack of Good Faith. To indemnify Indemnitee for any Expenses ------------------ incurred by the Indemnitee with respect to any action instituted (i) by Indemnitee to enforce or interpret this Agreement, if a court having jurisdiction over such action determines as provided in Section 13 that each of the material assertions made by the Indemnitee as a basis for such action was not made in good faith or was frivolous, or (ii) by or in the name of the Company to enforce or interpret this Agreement, if a court having jurisdiction over such action determines as provided in Section 13 that each of the material defenses asserted by Indemnitee in such action was made in bad faith or was frivolous. (d) Claims Under Section 16(b). To indemnify Indemnitee for expenses -------------------------- and the payment of profits arising from the purchase and sale by Indemnitee of securities in violation of Section 16(b) of the Securities Exchange Act of 1934, as amended, or any similar successor statute; provided, however, that notwithstanding any limitation set forth in this Section 10(d) regarding the Company's obligation to provide indemnification, Indemnitee shall be entitled under Section 3 to receive Expense Advances hereunder with respect to any such Claim unless and until a court having jurisdiction over the Claim shall have made a final judicial determination (as to which all rights of appeal therefrom have been exhausted or lapsed) that Indemnitee has violated said statute. 11. Counterparts. This Agreement may be executed in one or more ------------ counterparts, each of which shall constitute an original. 12. Binding Effect: Successors and Assigns. This Agreement shall be -------------------------------------- binding upon and inure to the benefit of and be enforceable by the parties hereto and their respective successors, assigns (including any direct or indirect successor by purchase, merger, consolidation or otherwise to all or substantially all of the business or assets of the Company), spouses, heirs and personal and legal representatives. The Company shall require and cause any successor (whether direct or indirect, and whether by purchase, merger, consolidation or otherwise) to all, substantially all, or a substantial part, of the business or assets of the Company, by written agreement in form and substance satisfactory to Indemnitee, expressly to assume and agree to perform this Agreement in the same manner and to the same extent that the Company would be required to perform if no such succession had taken place. This Agreement shall continue in effect regardless of whether Indemnitee continues to serve as a director, officer, employee, agent or fiduciary (as applicable) of the Company or of any other enterprise at the Company's request. 13. Expenses Incurred in Action Relating to Enforcement or Interpretation. --------------------------------------------------------------------- In the event that any action is instituted by Indemnitee under this Agreement or under any liability insurance policies maintained by the Company to enforce or interpret any of the terms hereof or thereof, Indemnitee shall be entitled to be indemnified for all Expenses incurred by Indemnitee with respect to such action (including without limitation attorneys' fees), regardless of whether Indemnitee is ultimately successful in such action, unless as a part of such action a court having 8 jurisdiction over such action makes a final judicial determination (as to which all rights of appeal therefrom have been exhausted or lapsed) that each of the material assertions made by Indemnitee as a basis for such action was not made in good faith or was frivolous; provided, however, that until such final judicial determination is made, Indemnitee shall be entitled under Section 3 to receive payment of Expense Advances hereunder with respect to such action. In the event of an action instituted by or in the name of the Company under this Agreement to enforce or interpret any of the terms of this Agreement, Indemnitee shall be entitled to be indemnified for all Expenses incurred by Indemnitee in defense of such action (including without limitation costs and expenses incurred with respect to Indemnitee's counterclaims and cross-claims made in such action), unless as a part of such action a court having jurisdiction over such action makes a final judicial determination (as to which all rights of appeal therefrom have been exhausted or lapsed) that each of the material defenses asserted by Indemnitee in such action was made in bad faith or was frivolous; provided, however, that until such final judicial determination is made, Indemnitee shall be entitled under Section 3 to receive payment of Expense Advances hereunder with respect to such action. 14. Notice. All notices, requests, demands and other communications under ------ this Agreement shall be in writing and shall be deemed duly given (i) if delivered by hand and signed for by the party addressed, on the date of such delivery, or (ii) if mailed by domestic certified or registered mail with postage prepaid, on the third business day after the date postmarked. Addresses for notice to either party are as shown on the signature page of this Agreement, or as subsequently modified by written notice. 15. Consent to Jurisdiction. The Company and Indemnitee each hereby ----------------------- irrevocably consent to the jurisdiction of the courts of the State of Delaware for all purposes in connection with any action or proceeding which arises out of or relates to this Agreement and agree that any action instituted under this Agreement shall be commenced, prosecuted and continued only in the Court of Chancery of the State of Delaware in and for New Castle County, which shall be the exclusive and only proper forum for adjudicating such a claim. 16. Severability. The provisions of this Agreement shall be severable in ------------ the event that any of the provisions hereof (including any provision within a single section, paragraph or sentence) are held by a court of competent jurisdiction to be invalid, void or otherwise unenforceable, and the remaining provisions shall remain enforceable to the fullest extent permitted by law. Furthermore, to the fullest extent possible, the provisions of this Agreement (including without limitation each portion of this Agreement containing any provision held to be invalid, void or otherwise unenforceable, that is not itself invalid, void or unenforceable) shall be construed so as to give effect to the intent manifested by the provision held invalid, illegal or unenforceable. 17. Choice of Law. This Agreement, and all rights, remedies, liabilities, ------------- powers and duties of the parties to this Agreement, shall be governed by and construed in accordance with the laws of the State of Delaware without regard to principles of conflicts of laws. 18. Subrogation. In the event of payment under this Agreement, the ----------- Company shall be subrogated to the extent of such payment to all of the rights of recovery of Indemnitee, who shall execute all documents required and shall do all acts that may be necessary to secure such rights and to enable the Company effectively to bring suit to enforce such rights. 9 19. Amendment and Termination. No amendment, modification, termination or ------------------------- cancellation of this Agreement shall be effective unless it is in writing signed by both the parties hereto. No waiver of any of the provisions of this Agreement shall be deemed to be or shall constitute a waiver of any other provisions hereof (whether or not similar), nor shall such waiver constitute a continuing waiver. 20. Integration and Entire Agreement. This Agreement sets forth the -------------------------------- entire understanding between the parties hereto and supersedes and merges all previous written and oral negotiations, commitments, understandings and agreements relating to the subject matter hereof between the parties hereto. 21. No Construction as Employment Agreement. Nothing contained in this --------------------------------------- Agreement shall be construed as giving Indemnitee any right to be retained in the employ of the Company or any of its subsidiaries or affiliated entities. IN WITNESS WHEREOF, the parties hereto have executed this Indemnification Agreement as of the date first above written. HOLLIS-EDEN PHARMACEUTICALS, INC. By:___________________________________________ Name: Richard B. Hollis Title: Chairman and CEO Address: Hollis-Eden Pharmaceuticals, Inc. 9333 Genesee Avenue, Suite 200 San Diego, CA 92121 AGREED TO AND ACCEPTED INDEMNITEE: _____________________________________ (signature) 10 EX-23.1 3 0003.txt CONSENT OF BDO SEIDMAN, LLP EXHIBIT 23.1 CONSENT OF INDEPENDENT CERTIFIED PUBLIC ACCOUNTANTS Hollis-Eden Pharmaceuticals, Inc. San Diego, CA We hereby consent to the incorporation by reference of our report dated January 19, 2001 relating to the financial statements of Hollis-Eden Pharmaceuticals, Inc., incorporated by reference into the Company's Annual Report on Form 10-K for the year ended December 31, 2000, into the prospectuses constituting a part of the following registration statements: No. 333-18725 on Form S-8 to Form S-4, No. 333-18725 on Form S-3 to Form S-4, No. 333-56155 on Form S-3, No. 333-56157 on Form S-3, No. 333-69725 on Form S-3, No. 333-69727 on Form S-3, No. 333-72853 on Form S-3, No. 333-92179 on Form S- 3, No. 333-92185 on Form S-8, No. 333-96181 on Form S-3, 333-96181 on Form S- 3, 333-34180 on Form S-3, 333-51284 on Form S-3 and 333-51286 on Form S-8. BDO Seidman, LLP New York, NY March 28, 2001
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