8-K

UNITED STATES

SECURITIES AND EXCHANGE COMMISSION

Washington, D.C. 20549

FORM 8-K

CURRENT REPORT

Pursuant to Section 13 or 15(d) of the

Securities Exchange Act of 1934

Date of Report (Date of earliest event reported): March 27, 2009

HOLLIS-EDEN PHARMACEUTICALS, INC.

(Exact name of registrant as specified in its charter)

Delaware

(State or other jurisdiction of incorporation)

000-24672	13-3697002
(Commission File No.)	(IRS Employer Identification No.)

4435 Eastgate Mall, Suite 400

San Diego, California 92121

(Address of principal executive offices and zip code)

Registrant’s telephone number, including area code: (858) 587-9333

Not Applicable.

(Former name or former address, if changed since last report)

Check the appropriate box below if the Form 8-K filing is intended to simultaneously satisfy the filing obligation of the registrant under any of the following provisions:

¨ Written communications pursuant to Rule 425 under the Securities Act (17 CFR 230.425)

¨ Soliciting material pursuant to Rule 14a-12 under the Exchange Act (17 CFR 240.14a-12)

¨ Pre-commencement communications pursuant to Rule 14d-2(b) under the Exchange Act (17 CFR 240.14d-2(b))

¨ Pre-commencement communications pursuant to Rule 13e-4(c) under the Exchange Act (17 CFR 240.13e-4(c))

ITEM 2.02.  RESULTS OF OPERATIONS AND FINANCIAL CONDITION.

On March 31, 2009, Hollis-Eden Pharmaceuticals, Inc. (the “Company”) issued a press release announcing its financial results for the fourth quarter and year ended December 31, 2008 and certain other information. A copy of this press release is attached as Exhibit 99.1 to this report and incorporation by reference herein.

The information contained in this report, including the exhibit hereto, is being furnished and shall not be deemed “filed” for purposes of Section 18 of the Securities Exchange Act of 1934, as amended (the “Exchange Act”), or otherwise subject to the liabilities of that section, nor shall it be incorporated by reference in any filing under the Securities Act of 1933, as amended, or the Exchange Act whether made before or after the date hereof, regardless of any general incorporation language in such filing.

ITEM 5.02.  DEPARTURE OF DIRECTORS OR PRINCIPAL OFFICERS; ELECTION OF DIRECTORS; APPOINTMENT OF CERTAIN OFFICERS; COMPENSATORY ARRANGEMENTS OF CERTAIN OFFICERS.

(b) On March 29, 2009, the Company received notice from Thomas C. Merigan, Jr., M.D. that he had resigned from the Company’s board of directors effective March 29, 2009 for personal reasons.

ITEM 7.01.  REGULATION FD DISCLOSURE.

On March 27, 2009, the Special Committee (consisting entirely of non-employee directors and constituting a majority of directors) (the “Special Committee”) of the Board of Directors (the “Board”) of the Company removed Richard Hollis, the Company’s former Chief Executive Officer, as Chairman of the Board and appointed Salvatore J. Zizza, a current director, as the non-executive Chairman of the Board.

On March 31, 2009, the Company included the following disclosure on p. 7 of its Annual Report on Form 10-K filed with the Securities and Exchange Commission on the same date:

“During 2008, Hollis-Eden initiated a Phase II clinical trial with TRIOLEX in type 2 diabetes patients. This Phase II, double-blinded placebo controlled 12-week dosing trial has enrolled over 90 patients with a hemoglobin A1c (HbA1c) level in excess of 7.5 percent who are on a stable dose of metformin only, the current first-line therapy for type 2 diabetes. The primary objectives of this trial are to evaluate the change in HbA1c from baseline to week 12 in the HE3286 treated group when compared to the placebo group and to evaluate the safety and tolerance of HE3286 10 mg per day (5 mg BID) compared to placebo from baseline to week 12.

We have completed three interim analyses of data from this on-going Phase II clinical trial with TRIOLEX in type 2 diabetes patients. The first interim analysis, which we planned pursuant to the study protocol when 25 percent of the subjects reached study-day 57, was completed in December 2008. The second interim analysis was completed in January 2009 and then expanded

in January 2009. The third interim analysis was completed in February 2009. Each interim analysis determined that, as of the date of such analysis, TRIOLEX was failing to meet its primary endpoint of lowering HbA1c in subjects treated with TRIOLEX compared to subjects treated with placebo. Each of these three interim analyses showed a statistically significant reversal in favor of placebo over TRIOLEX at day 57. The second interim analysis also showed a statistically significant reversal in favor of placebo over TRIOLEX at day 84 while the third interim analysis showed a trend in favor of placebo over TRIOLEX at day 84. Beginning with the first interim analysis, each of these interim analyses indicate that this trial will not achieve its primary endpoint of a statistically significant reduction in HbA1c at the conclusion of the trial for the total patient population. There were no safety related concerns identified in the interim analyses.

Enrollment in the trial is complete with 95 subjects. All subjects have completed dosing and we expect that the trial should be completed in the second quarter of 2009. We are evaluating all available data and will analyze the results from this study prior to determining the future development strategy for TRIOLEX in type 2 diabetes.”

The information contained in this report, including the exhibit hereto, is being furnished and shall not be deemed “filed” for purposes of Section 18 of the Securities Exchange Act of 1934, as amended (the “Exchange Act”), or otherwise subject to the liabilities of that section, nor shall it be incorporated by reference in any filing under the Securities Act of 1933, as amended, or the Exchange Act whether made before or after the date hereof, regardless of any general incorporation language in such filing.

By filing this Current Report on Form 8-K and furnishing this information, the Company makes no admission as to the materiality of any information in this Item 7.01 of Current Report on Form 8-K.

ITEM 9.01.  FINANCIAL STATEMENTS AND EXHIBITS.

(d) Exhibits.

99.1 Press release dated March 31, 2009.

SIGNATURE

Pursuant to the requirements of the Securities Exchange Act of 1934, as amended, the Registrant has duly caused this report to be signed on its behalf by the undersigned hereunto duly authorized.

	HOLLIS-EDEN PHARMACEUTICALS, INC.
Dated: March 31, 2009	By:	/s/ James M. Frincke
		James M. Frincke
		Interim Chief Executive Officer

EXHIBIT INDEX

99.1 Press release dated March 31, 2009.

EX-99.1

Exhibit 99.1

For Immediate Release

HOLLIS-EDEN PHARMACEUTICALS REPORTS FOURTH QUARTER AND YEAR-END 2008 FINANCIAL RESULTS

SAN DIEGO, CA – March 31, 2009 – Hollis-Eden Pharmaceuticals, Inc. (NASDAQ:HEPH) today reported financial results for the fourth quarter and year ended December 31, 2008.

For the quarter ended December 31, 2008, Hollis-Eden reported a net loss of $5.0 million (or $0.17 per share), compared to a net loss of $5.2 million (or $0.18 per share) in the fourth quarter of 2007. For the full year, the Company reported a net loss of $21.6 million (or $0.74 per share), compared to a net loss of $23.1 million (or $0.80 per share) for the full year 2007.

The net loss for the fourth quarter and full-year 2008 included approximately $674,000 and $2.5 million, respectively, of stock-based compensation expense related to the adoption of SFAS No. 123R, compared to $673,000 and $3.2 million in the comparable periods in 2007. Results for full-year 2007 include $645,000 in revenue generated from funding of research and development expenses by Cystic Fibrosis Foundation Therapeutics, Inc. under the Company’s collaboration agreement with the Foundation. There was no revenue recorded in 2008.

Research and development expenses for the fourth quarter of 2008 totaled $3.5 million, compared to $4.2 million in the fourth quarter of 2007. For full-year 2008, research and development expenses were $16.1 million compared to $18.3 million in 2007. The decrease in research and development expenses was due primarily to a decrease in head count, bonuses, and a decline in preclinical development offset by an increase in clinical trial expenses.

Fourth quarter 2008 general and administrative expenses were $1.5 million compared to $1.9 million in the fourth quarter of 2007, and full-year 2008 general and administrative expenses were $6.5 million compared to $8.1 million in 2007. The decrease in general and administrative expenses was due mainly to a decrease in executive head count, bonuses, Directors and Officers insurance, and in accounting and consulting fees.

Total other income and expenses were $1.0 million in 2008 compared to $2.7 million in 2007. The decrease in other income and expense for 2008 compared to 2007 was due mainly to lower interest rates and lower cash balances.

Cash used in operations for full-year 2008 totaled $19.0 million versus $23.7 million for full-year 2007. Year-end 2008 cash and equivalents totaled $24.2 million, compared to $43.2 million at December 31, 2007.

More detailed information is available in the Company’s Form 10-K, which was filed today with the Securities and Exchange Commission (http://www.sec.gov/cgi-bin/browse-edgar?action=getcompany&CIK=0000899394).

About Hollis-Eden Pharmaceuticals, Inc.

Hollis-Eden Pharmaceuticals, Inc. is developing a new series of small molecule compounds that are metabolites or synthetic analogs of endogenous hormones derived by the adrenal glands from the body’s most abundant circulating adrenal steroid. The Company’s clinical drug development candidates include TRIOLEX™ (HE3286), a next-generation compound currently in clinical trials for the treatment of type 2 diabetes, ulcerative colitis and rheumatoid arthritis, and APOPTONE™ (HE3235), a next-generation compound in a clinical trial for the treatment of late-stage prostate cancer. For more information on Hollis-Eden, visit the Company’s website at www.holliseden.com.

This press release contains forward-looking statements within the meaning of the federal securities laws concerning, among other things, the potential and prospects of the Company’s drug discovery program and its drug candidates. Any statement included in this press release that are not a description of historical facts are forward-looking statements that involve risks, uncertainties, assumptions and other factors which, if they do not materialize or prove correct, could cause the Company’s actual results to differ materially from historical results or those expressed or implied by such forward-looking statements. Such statements are subject to certain risks and uncertainties inherent in the Company’s business, including, but not limited to: the ability to complete preclinical and clinical trials successfully and within specified timelines, if at all; the ability to obtain regulatory approval for TRIOLEX (HE3286), APOPTONE (HE3235) or any other investigational drug candidate; the Company’s future capital needs; the Company’s ability to obtain additional funding; the ability of the Company to protect its intellectual property rights and to not infringe the intellectual property rights of others; the development of competitive products by other companies; and other risks detailed from time to time in the Company’s filings with the Securities and Exchange Commission. Existing and prospective investors are cautioned not to place undue reliance on these forward-looking statements, which speak only as of the date of this press release. Except as required by law, the Company undertakes no obligation to update or revise the information contained in this press release as a result of new information, future events or circumstances arising after the date of this press release.

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Contact:

Scott Rieger, Vice President, Corporate Communications

Hollis-Eden Pharmaceuticals, Inc.

(858) 587-9333