Latest capital market and finances developments compiled from 1 April—31 May 2015
Latest developments in the field of stem cell research and regenerative
medicine compiled from publicly available information and press releases
from non-academic institutions 1 April—31 May 2015, scheduled
to be published in Volume 10 Issue 6 of Regenerative Medicine.
Argos Therapeutics (NC, USA; www.argostherapeutics.com) has received US$ 6.6 million in funding from the NIH Division of AIDS for an investigator-initiated Phase IIa adult eradication study of AGS-004, the company’s investigational fully personalized immunotherapy for HIV based on proprietary Arcelis® technology platform. The Arcelis process uses only a small tumor or blood sample and the patient’s own dendritic cells, which are collected and optimized following a single leukopheresis procedure. RNA isolated from the patient’s disease sample is used to program dendritic cells to target disease specific antigens. The activated, antigen-loaded dendritic cells are then formulated into the patient’s plasma and administered via intradermal injection.
Celgene and Mesoblast
Mesoblast (Australia; www.mesoblast.com) has entered into an Agreement with Celgene (NJ, USA; www.celgene.com). Pursuant to this Agreement, Celgene will purchase Mesoblast stock and has a six-month right of first refusal to certain disease fields. Under the terms of the Agreement, Celgene will purchase 15.3 million ordinary shares in Mesoblast for a consideration of US$ 45 (A$ 58.5) million at a price of US$ 2.95 (A$ 3.82) per share. In addition, Celgene has a six-month right of first refusal with respect to Mesoblast’s proprietary mesenchymal lineage adult stem cell product candidates for the prevention and treatment of acute graft versus host disease, certain oncologic diseases, inflammatory bowel diseases, and organ transplant rejection.
BioTime’s (CA, USA; www.biotimeinc.com) subsidiary Cell Cure Neurosciences (Israel; www.cellcureneurosciences.com) has been awarded a grant for 2015 of US$ 1.61 million (6.24 million shekels) from Israel’s Office of the Chief Scientist to help finance the development of OpRegen®, a cell-based therapeutic product that consists of animal product-free RPE cells. Cell Cure is now enrolling patients at Hadassah University Medical Center in Jerusalem, Israel, in a clinical Phase I/IIa dose-escalation study evaluating the safety and efficacy of OpRegen for geographic atrophy, the severe stage of the dry form of age-related macular degeneration. The Phase I/IIa clinical trial was opened in February 2015 following regulatory clearance from the US FDA and the Israeli Ministry of Health. The trial consists of four cohorts and will evaluate three different dose regimens. Further information about this clinical trial are available at http://clinicaltrials.gov (ID: NCT02286089).
Cellular Dynamic International
Law office of Brodsky & Smith (PA, USA; http://brodsky-smith.com) is investigating potential claims against the Board of Directors of Cellular Dynamics International (WI, USA; www.cellulardynamics.com) for possible breaches of fiduciary duty and other violations of state law in connection with the sale of the Company to FUJIFILM (Japan; www.fujifilmholdings.com/en/index.html). Under the terms of the transaction, Cellular Dynamics shareholders will receive only US$ 16.50 in cash for each share of Cellular Dynamics stock they own. The investigation concerns whether the Board of Cellular Dynamics breached their fiduciary duties to stockholders by failing to adequately shop the Company before agreeing to enter into this transaction, and whether FUJIFILM is underpaying for Cellular Dynamics. The transaction may undervalue Cellular Dynamics given the growth potential of the Company’s technology platform. The technology platform enables the production of high-quality fully functioning human cells, including induced pluripotent stem cells on an industrial scale. In addition, the transaction will result in a loss for many long-term holders of Cellular Dynamics stock, which has traded at US$ 21.49 per share.
StemBioSys (TX, USA; www.stembiosys.com) has closed on US$ 8 million in Series A preferred stock financing that the company will use to help launch its initial product High Performance Microenvironment (HPMEâ„¢) advanced 3D stem cell culture system.
StemCells (CA, USA; www.stemcellsinc.com) has closed its previously announced offering of common stock and warrants. The Company sold a total of 35,715,000 shares and warrants to acquire 26,786,250 shares of common stock at a public offering price of US$ 0.70 per unit for a fixed combination of one share of common stock and a warrant to purchase three-quarters of a share of common stock. The Company also issued warrants to purchase additional 4,017,938 shares of common stock pursuant to the exercise of the underwriters’ option to acquire additional warrants covering over-allotments. The Company received total proceeds, net of offering expenses, underwriting discounts and commissions, of approximately US$ 23.35 million. The warrants have an exercise price of US$ 0.85 per share, are exercisable immediately, and will expire five years from the date of issuance. If the warrants are exercised in full, StemCells will receive additional proceeds of approximately US$ 26.2 million.