Prospectus Supplement filed pursuant to Rule 424(b)(3)
in connection with Registration Statement No. 333-115523
Aeolus Pharmaceuticals, Inc.
(f/k/a Incara Pharmaceuticals Corporation)
Prospectus Supplement No. 7 dated November 16, 2004
(To Prospectus dated May 27, 2004)
6,156,000 shares of common stock
This Prospectus Supplement supplements information contained in that certain Prospectus, dated May 27, 2004, as amended or supplemented, relating to the offer and sale by the selling stockholders listed in the Prospectus of up to 6,156,000 shares of common stock of Aeolus Pharmaceuticals, Inc. (f/k/a Incara Pharmaceuticals Corporation). This Prospectus Supplement is not complete without, and may not be delivered or used except in connection with, the original Prospectus. We will not receive any proceeds from the sale of the shares of common stock by selling stockholders.
As a result of the name change, which was effective on July 16, 2004, our common stock is traded on the OTC Bulletin Board under the symbol “AOLS.”
Filing of Current Report on Form 8-K
On November 16, 2004, James D. Crapo, our Chief Executive Officer, gave a presentation at the New York Society of Security Analysts 8th Annual Healthcare Industry Conference in New York, New York. Immediately prior to this presentation, we filed a Current Report on Form 8-K attached to which is a copy of that presentation. That Form 8-K is attached hereto in its entirety.
Investing in our common stock involves a high degree of risk. See “Risk Factors” beginning on page 3 of the original Prospectus.
NEITHER THE SEC NOR ANY STATE SECURITIES COMMISSION HAS APPROVED OR DISAPPROVED OUR SECURITIES OR DETERMINED THAT THE PROSPECTUS OR THIS PROSPECTUS SUPPLEMENT IS TRUTHFUL OR COMPLETE. IT IS ILLEGAL FOR ANYONE TO TELL YOU OTHERWISE.
The date of this Prospectus Supplement No. 7 is November 16, 2004
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) November 16, 2004
AEOLUS PHARMACEUTICALS, INC.
(Exact name of registrant as specified in its charter)
Delaware
(State or other jurisdiction of incorporation)
| 0-50481 | 56-1953785 | |
| (Commission File Number) | (IRS Employer ID Number) |
P.O. Box 14287
79 T. W. Alexander Drive
4401 Research Commons, Suite 200
| Research Triangle Park, North Carolina | 27709 | |
| (Address of principal executive offices) | (Zip Code) |
Registrant’s telephone number, including area code (919) 558-8688
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 7.01. | Regulation FD Disclosure. |
On November 16, 2004, at 12:00 noon Eastern Time, James D. Crapo, Chief Executive Officer of Aeolus Pharmaceuticals, Inc. (“Aeolus”), will give a presentation at the New York Society of Security Analysts 8th Annual Healthcare Industry Conference in New York, New York. A copy of that presentation is attached as an exhibit to this report and is incorporated herein by reference. An audio webcast replay of the presentation is expected to be available on Aeolus’ website, www.aeoluspharma.com, beginning on Monday, November 22, 2004.
The information furnished in this Item 7.01 shall not be deemed “filed” for purposes of Section 18 of the Securities Exchange Act of 1934, as amended, or otherwise subject to the liabilities of that section, nor shall such information be deemed incorporated by reference in any filing under the Securities Act of 1933, as amended, except as shall be expressly set forth by specific release in such a filing.
| Item 9.01. | Financial Statements and Exhibits. |
| (c) | Exhibits |
| Exhibit 99.1 | Slide presentation made at the New York Society of Security Analysts 8th Annual Healthcare Industry Conference on November 16, 2004 | |
2
SIGNATURE
Pursuant to the requirements 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.
| AEOLUS PHARMACEUTICALS, INC. | ||||
| Date: November 16, 2004 | ||||
| /s/ RICHARD W. REICHOW | ||||
| Richard W. Reichow | ||||
| Executive Vice President and Chief Financial Officer | ||||
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Exhibit 99.1
Exhibit 99.1
Developing Drugs for Cancer and Neurodegenerative Diseases
Except for historical information, all of the statements, expectations and assumptions discussed in today’s presentation, including statements and expectations regarding Aeolus’ scientific and preclinical studies, FDA filings and clinical trials, are forward-looking statements that involve a number of risks and uncertainties. Factors that could cause actual results and timetables to differ include uncertainties relating to scientific studies and preclinical and clinical trials, regulatory reviews and the need for additional funds for operations. Additional factors that could cause actual results and timetables to differ are set forth in Aeolus’ SEC filings. All forward-looking statements are based on information available as of the date of this presentation.
Aeolus Highlights
Revolutionary Compounds
Advancing in Clinic
Changing the Paradigm in Cancer Therapy
New Management
Aeolus
New Class of Small Molecule Antioxidants
10,000 times more potent than current antioxidant therapies
ALS Treatment
Phase 1 by subcutaneous route started Oct 2004
Preclinical testing of intrathecal route
Cancer / Radiation Protection
IND filing planned Q4 2004
Phase 1 in 1st half 2005
Phase 2 in 2nd half 2005
Antioxidants
aTocopherol
Non Enzymatic
1
Efficiency
Enzymatic
1,000 – 10,000
Ascorbate
ß Carotene
NAC
Superoxide Dismutase
Catalase
Mimetics
1,000 – 10,000
AEOL 10150
AEOL 10150
M.W. 1033.25
Water Soluble
Stable – Long Half-Life
Five-Step Synthesis
Molecular Formula: C48H56N12Cl5Mn
New Catalytic Antioxidants 200-compound SAR
CuZn SOD Enzyme
SOD Activity (U/mg)
5,100
Lead Compounds
AEOL 10150
AEOL 10113
14,789
10,648
Alternative Compounds
AEOL 10123
AEOL 10143
AEOL 10153
AEOL 10158
17,061
14,038
23,467
14,342
Intellectual Property
14 Patents Issued
41 Patents Pending
Composition Claims for Lead Molecules through 2020
Licenses from Duke University and National Jewish Medical and Research Center
Mechanisms of Action
Redox Active
Scavenge Reactive Oxygen Species
Cell Signaling
NO•
NF?B
Aeolus Focus
AEOL 10150 SC: ALS
AEOL 10150 SC: Cancer-Radiation Rx
AEOL 10113 SC: Cancer-Radiation Rx
Outlicense Opportunities
AEOL 10150 Ex Vivo: Transplant
AEOL 10150 IV: Stroke
AEOL 10113 IV: BPD
AEOL 10113 Aerosol: COPD
P/C IND Phase I Phase II
Pipeline
Aeolus – The Opportunity
Phase 1 ALS Patients
Phase 2
ALS
Phases 1 and 2
Cancer
Radiation Therapy
US 5,000 / year
US: 30,000 patients
US: 500,000 / year
ALS Amyotrophic Lateral Sclerosis
Progressive motor neuron degeneration and muscular atrophy
80% of patients die within 5 years of diagnosis
average lifespan 2-3 years post-onset
ALS treatments are “Fast Track” drugs
eligible for conditional approval based on one clinical study
J.P. Crow, unpublished, 2002-03
AEOL 10150 Prolongs Survival in ALS 2.5 mg/kg/day IP beginning with onset of symptoms
95
100
105
110
115
120
125
130
135
140
145
150
0.0
0.2
0.4
0.6
0.8
1.0
Cumulative Survival Probability
Age (days)
Control
AEOL 10150
G93A Mouse Videos
White mouse is a control.
Black mouse treated since symptom onset with AEOL 10150. Deficit is similar to that seen on first day of symptoms.
Conclusions – ALS
G93A Mouse – Enhanced Survival with Good Function – Dr. John Crow
Need to Determine if Efficacy Can Be Further Improved with Intrathecal Therapy
Cancer – Radiation Therapy A Unique Dual Mechanism
Protects Normal Tissues
Prevents Tumor Regrowth after Radiation Therapy
H2O
H
OH
DNA Damage
O2-
TGFB
Inflammation
Tissue Injury
Tumor
O2-
HIF-1
VEGF
Vessel Regrowth (angiogenesis)
Tumor Regrowth
X
X
Cancer Radiation Therapy – Dual Mechanisms of Action
Cancer – Radiation Therapy
Mimetics Prevent Tumor Regrowth following Radiation Therapy
Adenocarcinoma
4T1
RP9 Prostate Carcinoma
Aeolus Compounds Inhibit Adenocarcinoma Regrowth
R3230 Mammary Adenocarcinoma in F344 Rats
0.8
1
1.2
1.4
1.6
1.8
2
2.2
2.4
0
5
10
15
20
25
Relative tumor size
Days
AEOL 10113 stopped
* Radiation
Control
AEOL 10113
*
*
Aeolus Compounds Inhibit 4T1 Tumor Regrowth
Moeller et al. Cancer Cell 5:429, 2004
8
7
6
5
4
3
2
1
0
0
10
20
30
Time Post-Rx (Days)
Radiation + AEOL 10113
10mg/Kg at
0, 24 + 48 hr.
Radiation
Sham
Relative Tumor Volume
Radiation = 15 Gy in 3 fractions at 24-hour intervals in mice
Our Compounds Inhibit Prostate Tumor Regrowth
RP9 Tumors, 1-2 mice/group
AEOL 10150 injected i.p. daily from days 0-11
3500
3000
2500
2000
1500
1000
500
0
Days after 10 Gy Irradiation
Sham
Radiation
Radiation + AEOL 10150
1
8
10
12
15
19
21
Tumor Volume (mm3)
Gridley et al., Loma Linda
Tumor Adaptation to Radiation Therapy
HIF-1
Transillumination
Tumor Adaptation to Radiation Therapy
HRE-GP
White light
RT
+24 hours
+48 hours
Tumor Adaptation to Radiation Therapy
HRE-GFP
white light
RTSOD
+24 hours
+48 hours
HRE-GFP
white light
HIF-1 Activation
and
Angiogenesis
Blocked by Mimetic
Tumor Adaptation to Radiation Therapy
HRE-GFP
white light
RTSOD
+24 hours
+48 hours
HRE-GFP
white light
Aeolus Compounds Protect Normal Tissues
Oral Mucosa
Lung
Brain
Rectal Mucosa
28 Gy of right hemithoracic irradiation
p < 0.02
Rx 5 days
Aeolus Compounds Protect Lung against Radiation Damage
Breathing Rate
Weeks
100
120
140
160
180
200
220
0
2
4
6
8
10
12
14
16
18
20
Control
Radiation + AEOL 10113
Radiation
6 mg/kg/d IP for 5 days; n=9 rats per treatment
CONTROL
Lung Histology
Radiation
Radiation + AEOL10113
Aeolus Compounds Protect Lung against Radiation Damage
28 Gy of right hemithoracic irradiation
6 mg/kg/d IP for 5 days; n=9 rats per treatment
Conclusions: Cancer – Radiation Rx
Protection of Normal Tissues
No effective radioprotectant currently available
Inhibition of Tumor Regrowth following Radiation Therapy
Blocks tumor angiogenesis following radiation therapy
Clear Development Pathway
Phase 2 trial opportunities in multiple tumor types
Large Market
50% of cancers in US receive radiation therapy
Development Timeline
AEOL 10150: ALS
AEOL 10150:
AEOL 10113:
2004 2005 2006 2007
Phase 2
Phase 1b
Phase 1 SC
P 1
Phase 1
Phase 2
Cancer
Radiation Rx
Cancer
Radiation Rx
Phase 3
Phase 3
Phase 2
Phase 2
Safety
CEO – James Crapo
CFO Richard Reichow
CSO Brian Day
President, COO Regulatory Clinical Affairs Shayne Gad
Administrative Assistant
Asst Director Administration Ann Redick
SVP R&D Being Recruited
VP Chemistry
Bushra Agha
Scientific Collaborations
Cancer Mark Dewhirst, Ph.D. Duke University Zeljko Vujaskovic, M.D., Ph.D. Duke University James Slater, M.D. Loma Linda University
Neurodegenerative Disease David Warner, M.D. Duke University John Crow, Ph.D. University of Arkansas Robert Brown, M.D. Massachusetts General Flint Beal, M.D. Cornell University
Diabetes Michael Brownlee, M.D. Albert Einstein University Jon Piganelli, Ph.D. University of Pittsburgh
Respiratory Kent Pinkerton, Ph.D. University of California, Davis Russell Bowler, M.D., Ph.D. National Jewish Med. Center
Drug Synthesis Irwin Fridovich, Ph.D. Duke University Inez Batinic-Harberle, Ph.D. Duke University
Aeolus – Current Funding
$10,000,000 Institutional Support – April 2004
Phase 1 Safety Testing in ALS Patients
Scale Up and Synthesis of AEOL 10150
Support through 3rd Q 2005
SBIR from National Cancer Institute
$850,000 through May 2006
IND Filing for Cancer/Radiation Therapy
Aeolus – The Future
Phase 1 2004 in ALS Patients
Phase 2
ALS
Phase 1/2 – 1st half 2005
Cancer Radiation Therapy
Islet Cell Transplantation
Diabetes
COPD
Stroke
Cancer
Chemotherapy