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OLGC Orthologic (MM)

0.865
0.00 (0.00%)
19 Jul 2024 - Closed
Delayed by 15 minutes
Share Name Share Symbol Market Type
Orthologic (MM) NASDAQ:OLGC NASDAQ Common Stock
  Price Change % Change Share Price Bid Price Offer Price High Price Low Price Open Price Shares Traded Last Trade
  0.00 0.00% 0.865 0 01:00:00

OrthoLogic Reports First Quarter 2005 Results; Company Announces Completion of Patient Enrollment for Pivotal Phase 3 Trial of C

10/05/2005 12:00pm

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OrthoLogic Corp. (Nasdaq:OLGC) today announced financial results for the quarter ended March 31, 2005. The company also reported that patient enrollment has been completed in a pivotal Phase 3 human clinical trial evaluating Chrysalin in patients with unstable distal radius (wrist) fractures. Chrysalin, or TP508, is a 23-amino acid synthetic peptide representing a receptor-binding domain of the human thrombin molecule, a naturally occurring molecule in the body responsible for both blood clotting and the potential to accelerate the natural cascade of healing events in both soft tissue and bone repair. OrthoLogic reported a net loss of $5.5 million, or $(0.14) per share, for the quarter ended March 31, 2005. First quarter operating expenses totaled $6.1 million, an increase of $2.2 million compared to the first quarter of 2004. The increase was the result of the company's expanded efforts in research, development and clinical activities, and was in line with expectations. Collection Process Begins for Phase 3 Data A total of 502 patients with unstable and/or displaced distal radius fractures have now been enrolled in 27 U.S. centers, which constitutes full enrollment for this Phase 3 human clinical trial. The primary efficacy endpoint in the trial is to measure how quickly wrist fractures in patients injected with Chrysalin heal as measured by the removal of immobilization, which allows the patients to initiate hand therapy and regain full function of their wrists and hands. The clinical trial's secondary efficacy endpoints include radiographic healing, as well as clinical, functional and patient outcome parameters. To date, no adverse events have been reported to be related to Chrysalin in this trial. "We have achieved an important milestone in the development of this novel product candidate," said James M. Pusey, M.D., president and chief executive officer. "With the conclusion of patient enrollment, we now are working diligently to collect the data and expect to release initial efficacy results in the first half of 2006." The pivotal trial is a Phase 3 double-blind, randomized, placebo-controlled trial to compare the safety and efficacy of a single percutaneous injection of Chrysalin in saline at 10 ug/ml versus a saline placebo control. The trial includes physician evaluations and radiographs at multiple points in the study, from the time of a patient's first visit to a final safety evaluation at 52 weeks. The trial's hypothesis is that time to removal of rigid immobilization is shorter in the recipients of a single 10 ug/ml dose of Chrysalin than in the recipients of the saline placebo. Preclinical development of Chrysalin for fracture repair began in 1998, and clinical studies were initiated in 2000. In addition to the Phase 3 clinical trial, a Phase 2b dosing trial is underway to explore the impact on the time to removal of all rigid immobilization of Chrysalin at several doses versus a placebo control. "I am impressed with the profile of the Chrysalin peptide and the potential therapeutic value of the Chrysalin Product Platform," continued Dr. Pusey. "Our Chrysalin Product Platform includes three formulations and indications designed to address unmet medical needs. The board of directors and I believe the diabetic foot ulcer healing, spinal fusion and cartilage defect repair indications represent compelling development opportunities for our gel and microsphere formulations." Update on Chrysalin Clinical Trials and Preclinical Studies Fracture Repair: OrthoLogic is currently collecting the data for the fully enrolled Phase 3 study and expects to release initial efficacy results in the first half of 2006. During the first quarter of 2005, the company experienced a disruption in its supply of the Chrysalin-based injectable used in the Phase 2b dose-ranging human clinical trial. The interruption was resolved by amending the Investigational New Drug (IND) protocol for the Phase 2b trial to utilize a different supply source of Chrysalin. Enrollment in this trial has been slowed as the company continues to obtain Institutional Review Board (IRB) approvals of the amended protocol from the clinical trial sites. Diabetic Foot Ulcer Healing: The company is developing a gel formulation for a Chrysalin-based product candidate for diabetic foot ulcer healing in preparation for the next human clinical trial for this indication. The start date for this study will depend on successful completion of the gel formulation work, formulation-bridging preclinical studies and the submission of a formulation amendment to the existing and active IND application for this indication. Spinal Fusion: OrthoLogic is currently collecting data from its pilot Phase 1/2 clinical trial for spine fusion, which completed enrollment in the spring of 2004, and expects to have preliminary results this summer. To date, there have been no adverse events in this trial that were reported to be related to Chrysalin and patient follow-up has been excellent. Cartilage Defect Repair: OrthoLogic has completed several steps necessary to submit an IND application for a Chrysalin-based product candidate for cartilage defect repair. The company is working on completing the remaining steps and submitting an IND application for this indication. Cardiovascular Repair: OrthoLogic is evaluating various delivery mechanisms for a Chrysalin product candidate for myocardial revascularization, as well as completing a series of preclinical studies to support clinical development for this indication. "For the remainder of 2005 and beyond, OrthoLogic is committed to focusing on completing patient enrollment and analyzing data from the fracture repair clinical trials, and accelerating the development timeline for the additional product formulations. This is a very exciting time to lead the OrthoLogic team," concluded Dr. Pusey. OrthoLogic management will provide an update on the Chrysalin development program during its conference call later today. Conference Call Information As previously announced, a conference call hosted by OrthoLogic management is scheduled for later today at 12:00 p.m. EDT (9:00 a.m. PDT). To participate, please use the following numbers: 877-297-4509 (domestic) or 973-935-2402 (international). No reservation number is required. A replay of this call will be available beginning May 10, 2005 at 2 p.m. EDT until May 17, 2005 at 12 p.m. EDT. To access the replay, dial 877-519-4471 (domestic) or 973-341-3080 (international) and enter the following access code: 5989795. A live Webcast and Internet replay of the call will also be provided and can be accessed by visiting http://www.viavid.net/detailpage.aspx?sid=000024E3. The live Webcast and Internet replay can also be accessed from the Investor Relations section of OrthoLogic's Web site at www.orthologic.com. Additionally, all StreetEvents subscribers can access the Webcast from www.streetevents.com. About Chrysalin(R) Chrysalin (TP508) is a 23-amino acid peptide that represents the receptor-binding domain of the human thrombin molecule, the naturally occurring agent responsible for blood clotting and initiating many of the cellular events responsible for repair in both soft tissue and bone. All cells contain high-affinity thrombin receptors, which led to the hypothesis that thrombin did more than form blood clots after wounding. It was discovered that thrombin acted as a signaling molecule to initiate the early stages of tissue repair. The basis for the development of Chrysalin started in 1985, when a class of synthetic peptides was developed representing a specific receptor-binding domain of thrombin that activates specific wound-healing signals. Drugs based on the Chrysalin peptide can be used to mimic part of the thrombin response without stimulating the events associated with blood clotting and therefore have the potential to accelerate the natural cascade of healing events. About OrthoLogic Corp. OrthoLogic is a drug-development company focused on commercializing several potential therapeutics comprising the Chrysalin(R) Product Platform, a series of product candidates aimed at treating traumatic and chronic orthopedic indications in bone and soft tissue as well as cardiovascular repair and wound healing. All of these potential products are based on the Chrysalin synthetic peptide, also known as TP508. OrthoLogic owns an exclusive license for all worldwide medical indications for the peptide, and is actively pursuing five orthopedic indications for Chrysalin. These include fracture repair and spine fusion, which are in human clinical trials, and cartilage defect repair, which is in late-stage preclinical trials. Ligament and tendon repair indications are in the preclinical studies stage. In non-orthopedic areas, a human clinical trial for chronic diabetic foot ulcers has been completed. OrthoLogic's product development pipeline also includes Chrysalin-based product candidates for dental bone formation and myocardial revascularization. For more information, please visit the company's Web site: www.orthologic.com. Statements in this press release or otherwise attributable to OrthoLogic regarding our business that are not historical facts are made pursuant to the safe harbor provisions of the Private Securities Litigation Reform Act of 1995. These forward-looking statements, which include the timing and acceptability of FDA filings and the efficacy and marketability of potential products, involve risks and uncertainties that could cause actual results to differ materially from predicted results. These risks include: delays in obtaining or inability to obtain FDA, institutional review board or other regulatory approvals of preclinical or clinical testing; unfavorable outcomes in our preclinical and clinical testing; the development by others of competing technologies and therapeutics that may have greater efficacy and/or lower cost; interruptions in the availability of our supply of Chrysalin for clinical trials; delays in obtaining or inability to obtain FDA or other necessary regulatory approval of our products; our inability to successfully and cost effectively develop or outsource manufacturing and marketing of any products we are able to bring to market; changes in FDA or other regulations that affect our ability to obtain regulatory approval of our products, increase our manufacturing costs or limit our ability to market our products; our possible need for additional capital in the future to fund the continued development of our Chrysalin Product Platform; and other factors discussed in our Form 10-K for the fiscal year ended December 31, 2004, and other documents we file with the Securities and Exchange Commission. Note to Editors: A "u" represents the micron symbol when used as part of "um/gl" throughout this release. -0- *T ORTHOLOGIC CORP. (A Development Stage Company) STATEMENTS OF OPERATIONS (in thousands, except per share data) (Unaudited) Three months As a Development ended March 31, Stage Company ------------------ OPERATING EXPENSES 2005 2004 8/5/04-3/31/05 ------------------------------------ General and administrative $910 $555 $2,788 Research and development 5,403 3,371 13,483 CPM divestiture and related gains (250) (111) (375) CBI in process research and development 0 0 25,840 -------- -------- ------------------ Total operating expense (6,063) (3,815) (41,736) Interest income, net 552 306 1,303 -------- -------- ------------------ Loss from continuing operations before taxes (5,511) (3,509) (40,433) Income tax benefit (12) (294) (654) -------- -------- ------------------ Net loss from continuing operations $(5,499) $(3,215) $(39,779) Discontinued operations Net gain on the sale of the Bone Device Business, net of tax benefit of ($363) 0 0 2,048 -------- -------- ----------------- Net income from discontinued operations 0 0 2,048 -------- -------- ----------------- NET INCOME (LOSS) $(5,499) $(3,215) $(37,731) ======== ======== ================= Per Share Information: Net loss from continuing operations Basic $(0.14) $(0.09) ======== ======== Diluted $(0.14) $(0.09) ======== ======== Net income from discontinued operations Basic $(0.00) $(0.00) ======== ======== Diluted $(0.00) $(0.00) ======== ======== Net income (loss) Basic $(0.14) $(0.09) ======== ======== Diluted $(0.14) $(0.09) ======== ======== Basic and diluted shares outstanding 38,047 34,310 ======== ======== ORTHOLOGIC CORP. (A Development Stage Company) BALANCE SHEETS (in thousands except share and per share data) March 31, December 31, ---------------- -------------- 2005 2004 -------------------------------------- ---------------- -------------- ASSETS (Unaudited) Current assets: Cash and cash equivalents $29,993 $38,377 Short-term investments 61,828 53,642 Accounts receivable 29 34 Prepaids and other current assets 1,104 1,019 ---------------- -------------- Total current assets $92,954 $93,072 Furniture and equipment, net 424 478 Escrow receivable, net 6,857 6,828 Long-term investments 5,347 11,558 Deferred income taxes -- non-current 1,106 1,106 Trademarks 2,142 2,142 ---------------- -------------- Total assets $108,830 $115,184 ================ ============== LIABILITIES AND STOCKHOLDERS' EQUITY Current liabilities: Accounts payable 501 833 Accrued compensation 302 648 Accrued taxes 80 114 Excess space reserve 461 559 Accrued clinical 1,230 1,236 Other accrued liabilities 706 727 ---------------- -------------- Total current liabilities 3,280 4,117 ---------------- -------------- Deferred rent and capital lease obligation 119 137 ---------------- -------------- Total liabilities $3,399 $4,254 ---------------- -------------- Stockholders' Equity Common stock, $.0005 par value; 100,000,000 and 50,000,000 shares authorized; 38,211,642 and 38,011,642 shares issued and outstanding 19 19 Additional paid-in capital 170,905 170,905 Accumulated deficit (65,493) (59,994) Total stockholders' equity 105,431 110,930 ---------------- -------------- Total liabilities and stockholders' equity $108,830 $115,184 ================ ============== *T

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