Bioheart Inc. filed for an initial public offering, hoping to raise $35 million to fund an upcoming late-stage trial of MyoCell, its autologous cell-based alternative to existing heart failure treatments.
The Sunrise, Fla.-based firm is seeking a Nasdaq listing under the ticker "BHRT."
While Bioheart has not yet specified the share price or number of shares to be offered, the company said in its prospectus that proceeds will fund trials of MyoCell, a product that takes myoblasts removed from a patient's thigh muscle, grows them through a cell-culturing process and injects the cells into scar tissue within the heart wall using the company's MyoCath catheter.
MyoCell is in two ongoing Phase II studies, including a 46-patient study that Bioheart hopes to serve as the basis for European marketing approval for the sickest subgroup of heart failure patients. Final results from that study are expected in the fourth quarter.
The company submitted a protocol to the FDA for a potentially pivotal Phase II trial involving 450 patients defined as having Class II or Class III heart failure, as determined by the New York Heart Association classification. Those categories are estimated to comprise about 60 percent of the overall 5.2 million U.S. heart failure patient population.
If the agency approves the protocol, Bioheart expects to complete enrollment and treatment by the second quarter of 2008, with final trial results available in the first quarter of 2009.
If MyoCell succeeds in gaining approval, it would offer patients another option for heart failure therapy, which currently includes transplants, drugs and devices such as pacemakers and implanted metal and plastic pumps. While those products do improve cardiac function, the company said MyoCell could be the first treatment actually able to generate new muscle tissue.
Bioheart anticipates building its own sales staff to market MyoCell, with the complementary MyoCath product, a disposable endoventricular catheter for the direct myocardium delivery of biologic solutions.
Remaining proceeds from the IPO would be used to further develop the company's intellectual property portfolio, to fund development of other pipeline products and for general corporate purposes.
Behind MyoCell, Bioheart is developing several therapies and related devices, such as the TGI 100 Wound Dressing Kit, which is designed to prepare a cellulose-coated wound dressing from patient-derived fat cells, and the TGI 1200 Adipose Tissue Processing System, a device for processing patient-derived fat tissue for acute myocardial infarction and heart failure.
Earlier in the pipeline, the company has MyoCell II with SDF-1, a non-acute autologous cell-based treatment for heart damage in which the patients' myoblasts are modified to express SDF-1 protein to stimulate angiogenesis. Bioheart is preparing an investigational new drug application for that product.
Since it was founded in January 1999, the company has been funded by private placements totaling about $52.5 million. The most recent financing was a $19 million Series D round in the fall of 2005. Bioheart reported a net loss of $10.9 million for the first nine months of 2006. As of Sept. 30, its cash and cash investments totaled $5.2 million. (See BioWorld Today, Sept. 28, 2005.)
Bioheart ended January with 21.5 million shares outstanding, and a third of those - about 7.5 million - are held by company co-founder, President and CEO Howard Leonhardt, who owns about 35 percent of the firm.
BMO Capital Markets Corp. will act as sole book-running manager for the proposed offering, with Janney Montgomery Scott LLC serving as co-lead manager and Merriman Curhan Ford & Co. serving as co-manager.
In other financings news:
• Active Biotech AB, of Lund, Sweden, said its previously announced preferential rights issue, which was oversubscribed by 53 percent, brought in SEK240 million (US$34.7 million). Following the offering, the company will increase its outstanding shares to 44 million. Active Biotech focuses on researching and developing its pipeline products aimed at autoimmune/inflammatory diseases and cancer. Its most advanced projects are laquinimod, an oral small molecule for multiple sclerosis, and Anyara, a targeted cancer therapy.
• Adherex Technologies Inc., of Research Triangle Park, N.C., filed a final short-form prospectus with the regulatory authorities in British Columbia, Alberta and Ontario. It plans to sell up to US$25 million in equity, consisting of 30.3 million units at $0.33 per unit, and up to 45.46 million additional units. Each unit consists of one common share and half a warrant. Each three-year whole warrant will entitle the holder to acquire one share at $0.40 per share. The sale is being made under a previously announced agreement between Adherex and Versant Partners Inc., which already committed to purchase the first 30.2 million units ($10 million).
• BioMimetic Therapeutics Inc., of Franklin, Tenn., completed of a public offering of about 3.25 million shares at $17.15 per share, including 424,350 shares sold upon full exercise of the underwriters' overallotment option. About 2.52 million of the shares were sold by the company - for gross proceeds of about $43.2 million — with the remainder sold by stockholders. Deutsche Bank Securities Inc. was sole book-running manager, while Pacific Growth Equities LLC was co-lead manager. First Albany Capital Inc. and A.G. Edwards & Sons Inc. were co-managers. The company is developing drug-device combination products for the healing of musculoskeletal injuries and disease, including periodontal, orthopedic, spine and sports injury applications. Its first product, GEM 21S, is approved for use as a grafting material for bone and periodontal regeneration.
• Kosan Biosciences Inc., of Hayward, Calif., completed its previously announced registered direct offering of 7 million shares of common stock at $6.50 per share, for gross proceeds of $45.5 million. (See BioWorld Today, Feb. 12, 2007.)
• Pluristem Life Systems Inc., of New York, signed a binding term sheet with investors for an $8 million private equity investment. Investors will receive Pluristem restricted common stock priced at 1 cent per share and a warrant to purchase additional shares priced at 2.5 cents each. The first payment of funds totaling nearly $1.3 million has been received, and the final agreement is expected to be completed by March 15.
• SemBioSys Genetics Inc., of Calgary, Alberta, entered an underwriting agreement to offer 7 million shares priced at $3 each. Of those shares, about 4.3 million are being offering by the company to raise gross proceeds of $12.8 million. SemBioSys develops and produces products based on its plant genetic engineering skills and its Stratosome Biologics System, an oilbody-oleosin technology platform. The remaining 2.7 million shares are being offered by company stockholders, and SemBioSys will not receive proceeds from that sale. The offering is expected to close on or around Feb. 20.
• Symbollon Pharmaceuticals Inc., of Framingham, Mass., said it completed a private placement to accredited investors in December and January, raising net proceeds of $2.37 million. It sold 3.21 million Class A common shares along with 2.4 million warrants. Proceeds will be used to fund the ongoing Phase III pivotal clinical trial evaluating IoGen for the treatment of pain and tenderness associated with fibrocystic breast disease, as well as working capital needs.
• Vion Pharmaceuticals Inc., of New Haven, Conn., agreed to sell up to $60 million principal amount of its convertible senior notes due in 2012 and warrants to purchase up to 7.8 million shares of Vion common stock in a private placement. The company expects to use the proceeds for general corporate purposes. The offering is expected to close on or about Feb. 20.