What's Happening Now is a quick, thoughtful, real-time briefing regarding material events in the stem cell industry...definitely not the usual stream of insignificant press releases. The most current Happenings are boxed on the left-hand side of most pages on this site. Feel free to use this page to explore the archive of all past Happening items, and subscribe to the RSS feed to stay on top of the events that move the market and the industry.
Capricor One Step Closer to Reverse Merger and Public Trading
Nov 14, 2013
Cardiac stem cell developer Capricor
, Inc. (not a SCSI component company) moved closer to completing its proposed reverse merger with failed Nile Therapeutics (OTCMKTS:NLTX) this week when the latter's shareholders approved
critical terms of the proposed deal, which would provide Capricor with much-needed access to public capital markets to fund its clinical trials.
ThermoGenesis Takes Next Step Toward Merger With TotipotentRx
Nov 8, 2013
(KOOL) filed an S-4
with the Securities and Exchange Commission, seeking shareholder approval of its planned cashless merger with little-known TotipotentRx
, whose owners would receive at least 43% of the resulting NASDAQ-traded company, to be re-named Cesca Therapeutics. A date for the shareholders' meeting to approve the proposal is still to be determined.
Fate Shares Dip Below Their IPO Price
Nov 6, 2013
(FATE) shares slipped below their October 1st $6 IPO price for the first time, despite the recent high-profile publication
of encouraging results from its Phase 1 ProHema trial and apparent progress in Phase 2 trials. FATE closed the day at $5.95.
Cellular Dynamics Begins 3,000-Patient iPSC Bank
Nov 5, 2013
Cellular Dynamics International
receipt of a Notice of Grant Award from CIRM, kicking off CDI's $16M project to bank 9,000 iPSC cell lines from 3,000 healthy and diseased donors.
Who Is Cytori's new partner, Lorem Vascular?
Nov 5, 2013
Cytori Soars on News of Asia Deal
Nov 5, 2013
(CYTX) shares were up over 60% on news
of a deal with China's Lorem Vascular. Lorem will exclusively license the Celution System for a broad range of medical indications in China, Hong Kong, Malaysia, Singapore and Australia. The deal involves upfront payments to Cytori of $14 million, plus contingent payments and royalties that could reach $500 million over 30 years.
ThermoGenesis Reorganizes, Announces Layoffs
Oct 31, 2013
On the heels of steadily declining revenues and a $3M loss last year, ThermoGenesis
(KOOL) today announced
the layoff of 11 employees.
Mesoblast Receives FDA Approval for Potentially Record-Setting Heart Failure Trial
Oct 31, 2013
(not a SCSI component) received FDA approval
for a Phase 3 trial of subsidiary Angioblast's MSCs in congestive heart failure, to be led by partner Teva Pharmaceuticals. It joins Belgium's Cardio3 as a Phase 3 heart failure contender. As planned, the trial's anticipated enrollment of 1,700 patients would be record-setting for a commercial stem cell trial.
StemCells Acquires Neural Stem Cell Patents On the Cheap
Oct 29, 2013
it acquired the Weiss/Reynolds neural stem cell patents (that it had previously licensed from the Univ. of Calgary) for a surprising 140,000 STEM shares (about $200K). StemCells and Neuralstem
are embroiled in lawsuits regarding the patents' claims.
BioTime Floats Odd Proposal to Finance Its ESC Development Program
Oct 28, 2013
(BTX) floated a proposal in a press release
suggesting its majority-owned subsidiary, Asterias Biotherapeutics (formed during BioTime's acquisition of Geron's shuttered ESC program), may offer a highly creative financing plan that could amount to a three year interest-free loan of $15 million at investors' expense. The company suggested it plans to file a registration statement with the SEC for the offer in November.
StemCells Reviews Four-Year Followup of Batten Disease Trial
Oct 21, 2013
the results of a four-year followup of 6 patients treated with its HuCNS-SC cells in its Phase 1 trial
for neuronal ceroid lipofuscinosis. No safety issues were reported, "but the clinical outcomes were generally consistent with the expected course of impairment associated with this neurodegenerative disease."
StemCells To Present Spinal Cord Injury Trial Interim Results
Oct 17, 2013
With 7 of a planned 12 patients now treated, StemCells
(STEM) collaborator Raphael Guzman will discuss
interim results from the company's spinal cord injury trial of its HuCNS-SC cells the afternoon of Oct. 23rd at the Congress of Neurological Surgeons Annual Meeting.
ThermoGenesis Partner, TotipotentRx, Releases Case Study 'White Paper' Recommending Caution
Oct 16, 2013
(KOOL) upcoming merger partner, TotipotentRx, released a 'white paper
' warning that the improvement in left ventricular ejection fraction (LVEF) of one heart attack patient receiving its volume-reduced bone marrow aspirate (up from 36% pre-treatment to 60% 24 months post-treatment) that it announced in its press release yesterday, should be "evaluated cautiously" as the study employed non-comparable LVEF measurement methods at the two time-points (2D echo and MRI, respectively).
ThermoGenesis Touts 'Case Study,' Remains Silent On Clinical Trial Outcome
Oct 14, 2013
On the brink of going public in a merger with ThermoGenesis (KOOL)
, TotipotentRx's CEO claimed in a press release
that a single heart attack patient treated with KOOL's volume-reduced bone marrow aspirate in India achieved a two-year ejection fraction improvement from 35% to 60%. The company remained silent regarding the outcome of KOOL's critical limb ischemia clinical trial, which it reported in September
had reached its primary completion point.
Osiris Sells Off Stem Cell Business
Oct 11, 2013
As we speculated in a recent essay
, Osiris Therapeutics
(OSIR) has lost interest in its stem cell business (in favor of its wound dressing product). The company announced
the sale of its stem cell assets, including Canadian-approved cell therapy Prochymal, to Australia's Mesoblast Ltd. in a transaction worth up to $100 million including milestones...a fraction of the $500 million the company's CEO recently stated Osiris had spent developing Prochymal.
Aastrom Announces Reverse Stock Split, Shares Plunge
Oct 11, 2013
Following a trend increasingly common among wilting stem cell penny stocks, Aastrom
a 1-for-20 reverse stock split intended to hike its share price above $1 to meet NASDAQ's listing requirements. At the opening bell this morning ASTM dropped 23% on the news.
Cytori's ADVANCE Trial Update Reveals Chronic Recruiting Problem
Oct 8, 2013
(CYTX) latest update
to the ClinicalTrials.gov record of its now abandoned ADVANCE trial for myocardial infarction reveals that just 23 patients (of an original goal of 360) were recruited to the trial in over 2 years of effort, validating the Nov. 2012 red flag (for insufficient progress) given this trial by our Clinical Trials Monitor
, when CYTX shares were 55% higher than today.
Pluristem Gains Israeli Approval For Trial
Oct 4, 2013
Israel-based (but U.S. incorporated) Pluristem
(PSTI) has received
government approval to include Israeli sites in its current Phase 2 trial
of PLX-PAD cells for intermittent claudication. The approval allows the company to add sites in Israel to the trial's current sites in Germany and the U.S.
StemCells Discounts New Share Offering
Oct 2, 2013
In an SEC document
filed today, StemCells
(STEM) announced its intention to sell an unspecified number of new shares plus warrants at a price of $1.45, a significant discount over yesterday's closing price of $1.68.
Fate Therapeutics IPO Comes In at Bottom of Price Range
Oct 2, 2013
Fate Therapeutics< Previous Page
(FATE) final prospectus
for its IPO, filed yesterday with the SEC, prices the offering of 7.7 million shares at $6 per share, the bottom of its previously anticipated range ($6-$8). Fate now becomes the 17th publicly traded U.S. stem cell-focused company to be covered by the SCSI.
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