Fri, Feb. 13, 10:24 AM| 1 Comment
Thu, Feb. 12, 4:11 PM| Comment!
Fri, Jan. 2, 9:14 AM
Fri, Jan. 2, 7:14 AM
- The FDA does not approve Cesca Therapeutics' (NASDAQ:KOOL) investigational device exemption (IDE) application to begin a 224-patient Phase 3 study assessing its SurgWerks-CLI and VXP system for the treatment of critical limb ischemia (CLI). The company filed its application on November 20.
- In a letter to the firm, the agency noted several deficiencies in the submission. It requested additional information on the characterization of the output of the SurgWerks -CLI and VXP system, a plan for testing device output for conformity to predefined intraoperative release criteria prior to administration, modifications to the management of potential adverse events and strengthening of the language in the risk clauses in the Informed Consent Document.
- Cesca plans to submit its amended IDE in February.
- No premarket trades have been reported.
- Previously: Cesca up on IDE filing (Nov. 20, 2014)
Nov. 20, 2014, 3:50 PM
- Thinly-traded nano cap Cesca Therapeutics (KOOL +16%) enjoys an up day on a 6x surge in volume albeit on turnover of ~380K shares.
- This morning the company announced its IDE filing for a Phase 3 multicenter study to evaluate the safety and efficacy of is SurgWerks-CLI and VXP System for the treatment of advanced stages of no-option lower limb critical limb ischemia. The primary endpoint of the proposed trial will be major amputation-free survival at 12 months.
Nov. 13, 2014, 4:16 PM| Comment!
Nov. 12, 2014, 9:29 AM
Sep. 29, 2014, 10:28 AM
- Cesca Therapeutics (KOOL -3.3%) financial results:
- Fiscal Q4: Revenues: $3.8M (-7.5%); Gross Profit: $1.2M (+7.4%); Operating Expenses: $4.4M (+28.3%); Net Loss: ($2.9M) (-20.0%); Loss Per Share: ($0.08) (+42.9%); Quick Assets: $14.8M (+115.2%).
- Fiscal 2014: Revenues: $16.0M (-11.0%); Gross Profit: $5.9M (-7.5%); Operating Expenses: $14.9M (+58.3%); Net Loss: ($8.6M) (-179.7%); Loss Per Share: ($0.36) (-89.5%); Cash Burn: ($7.8M) (-154.3%).
- No financial guidance given.
Sep. 29, 2014, 6:59 AM| Comment!
Sep. 10, 2014, 7:25 AM
- Cesca Therapeutics (NASDAQ:KOOL) files suit in the U.S. District Court, Eastern District of California against SynGen et al. (Case No. 2:14-cv-02085-GEB-KJN) alleging the SynGenX-1000 and the patent application "System for Purifying Certain Cell Populations in Blood or Bone Marrow by Depleting Others" were developed using Cesca confidential information and that Cesca is the equitable owner. Cesca accuses the defendants of misappropriation of trade secrets, breach of contract and other claims.
- Cesca plans to update shareholders on the progress of the suit via its 10-Q filings.
Jun. 13, 2014, 12:46 PM
Jun. 13, 2014, 9:16 AM
- Cesca Therapeutics (KOOL) offers 7.53M units for public sale at $1.50/unit. Each unit consists of one share of common stock and one warrant to purchase 0.30 shares of common stock at $1.55/share for a term of five years. The warrants are immediately exercisable. Gross proceeds, including the exercise of all warrants, will be ~$11.3M. Closing date is June 18.
Jun. 10, 2014, 9:13 AM
May. 15, 2014, 4:53 PM
May. 1, 2014, 9:13 AM
Apr. 24, 2014, 12:46 PM
KOOL vs. ETF Alternatives
Cesca Therapeutics Inc is engaged in the research, development, and commercialization of autologous cell-based therapeutics for use in regenerative medicine. It develops and manufactures automated blood and bone marrow processing systems.
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