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Company Links |
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Major Stock Holders
(Prior To
Offering) |
Name |
Common Stock |
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Entities affiliated with Morgenthaler Partners VII, L.P |
5,454,545 |
NA |
NA |
NA |
NA |
NA |
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Entities affiliated with ProQuest Investments |
5,280,303 |
NA |
NA |
NA |
NA |
NA |
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Entities affiliated with Sofinnova Ventures, Inc. |
5,280,303 |
NA |
NA |
NA |
NA |
NA |
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Entities affiliated with Three Arch Partners |
5,280,303 |
NA |
NA |
NA |
NA |
NA |
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Pequot Capital Management, Inc. |
5,454,545 |
NA |
NA |
NA |
NA |
NA |
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Business Environment |
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The American Cancer Society estimates that 31,860 patients will be diagnosed with pancreatic cancer in the United States in 2004, and approximately 31,270 patients will die from the disease. Only 15-20% of newly diagnosed patients are eligible for surgery, which is typically followed by radiation and chemotherapy. Patients with inoperable pancreatic cancer are treated with radiation and chemotherapy, or in the case of advanced disease, chemotherapy alone as the advantages of radiation are reduced. Gemzar is the standard of care for the first-line therapy of advanced metastatic pancreatic cancer. The largest published trial of Gemzar in advanced pancreatic cancer reported a median survival of 5.4 months. In Gemzar’s Phase 3 registrational trial, median survival was 5.7 months, and no patient survived beyond two years. In this study, patients treated with 5-flurouracil, or 5-FU, the previous standard of care, had a median survival of 4.2 months, and no patient survived beyond two years during the study. None of the 126 patients treated in both arms of this study achieved tumor shrinkage. Estimated worldwide 2003 sales of Gemzar for pancreatic cancer were $422 million.
As a man ages, it is common for his prostate to enlarge. This enlargement process begins as early as age 25 but does not cause problems until later in life, when the prostate presses against the urethra and symptoms of BPH become evident. Because the prostate surrounds the urethra, BPH can restrict the flow of urine, resulting in urine retention, which can cause weakening of the bladder wall and the inability to empty the bladder completely. The most common symptoms of BPH include a weak and interrupted urine stream, urgency, leaking and frequent urination. Severe BPH can result in urinary tract infections, kidney and bladder damage, bladder stones and incontinence.
The National Institutes of Health, or NIH, estimates that more than 50% of men in their sixties and approximately 90% of men over seventy have some symptoms of BPH. Approximately 17 million men in the United States, 27 million men in five major European countries and eight million men in Japan are estimated to suffer from symptoms of the disease and could benefit from a safe and effective treatment for BPH. Approximately 21% of them have been diagnosed, of which 59% receive medical therapy. In the United States, 2.0 million men are treated with drugs. These numbers are expected to increase in the future due to increased awareness and the aging population.
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Company Strategy |
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A biotechnology company focused on the discovery, development and commercialization of drugs based on Metabolic Targeting, an approach that targets fundamental differences in metabolism between normal and certain diseased cells. |
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Product/Services Portfolio |
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The Company’s lead product candidate for cancer, glufosfamide, is a small molecule in clinical development for the treatment of pancreatic cancer. In September 2004, the Company initiated a pivotal Phase 3 trial to support marketing approval of glufosfamide for the second-line treatment of metastatic pancreatic cancer.
Glufosfamide combines the active part of an approved alkylator, a member of a widely used class of chemotherapy drugs, with a glucose molecule. Because of its glucose component and a tumor cell’s increased need for glucose, glufosfamide is preferentially transported into tumors compared to most normal tissues. Thus Metabolic Targeting offers the potential to provide increased selectivity for tumor cells and thereby improve the treatment of many solid tumors. Inside cells, the linkage between glucose and the alkylator is cleaved to release the active drug. With glucose as the side product, glufosfamide has fewer side effects than other drugs in its class, which are known to cause hemorrhagic cystitis, a serious condition characterized by severe bladder bleeding.
TH-070, the Company’s lead product candidate for the treatment of symptomatic BPH, is an orally administered small molecule that has been reported to inhibit glycolysis by inactivating hexokinase, the enzyme that catalyzes the first step in glycolysis. By inhibiting glycolysis, TH-070 kills prostate cells, reducing the size of the prostate, and therefore may provide an effective treatment for symptomatic BPH. The Company have completed enrollment and are evaluating interim clinical data from a Phase 2 trial of TH-070 for the treatment of symptomatic BPH.
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Investment Analysis |
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Research and development expenses for the nine months ended September 30, 2004 The Companyre $10.9 million compared to $4.9 million for the nine months ended September 30, 2003.
Discovery research expenses The Companyre approximately $2.0 million for the nine months ended September 30, 2004 and The Companyre $0.5 million for the nine months ended September 30, 2003.
General and administrative expenses for the nine months ended September 30, 2004 The Companyre $5.1 million versus $1.6 million for the nine months ended September 30, 2003.
Interest income for the nine months ended September 30, 2004 was $312,794 compared to $17,488 for the nine months ended September 30, 2003.
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Income Data |
| Year |
Revenues |
Costs |
Oper Income |
Taxes |
Net Income |
EPS |
| 2001
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0.00 |
236 |
0.00 |
0.00 |
-236 |
-1.29000000000000003552713678800500929355621337890625 |
| 2002
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0.00 |
2485 |
27 |
0.00 |
-2458 |
-21.190000000000001278976924368180334568023681640625 |
| 2003
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0.00 |
8309 |
65 |
0.00 |
-8303 |
-305.3700000000000045474735088646411895751953125 |
| *As of period from Oct 17, 2001 to Dec 31, 2001
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Balance Sheet Data
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Year |
Cash |
Acct Recv. |
Inventory |
Total Cur Assets |
Total Cur Liability |
PPE |
Total Assets |
LT Debt |
SH Equity |
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2002 |
6215 |
0.00 |
0.00 |
6570 |
416 |
71 |
6726 |
0.00 |
-2667 |
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2003 |
40609 |
0.00 |
0.00 |
41061 |
884 |
199 |
41270 |
0.00 |
-9695 |
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| Cash
Flow Summary
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Year |
Net Cash-Ops |
Net Cash-Inv |
Net Cash-Fin |
Net Change |
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2001 |
-51 |
0.00 |
238 |
187 |
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2002 |
-2469 |
-248 |
8745 |
6028 |
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2003 |
-6659 |
-218 |
41271 |
34394 |
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*As of period from Oct 17, 2001 to Dec 31, 2001
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