Happenings Archive

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.

COMPANY:

Soon-To-Be Cesca (ThermoGenesis) Revenues and Margin Down Again; Trial Delayed
Feb 19, 2014
Following last week's shareholder approval of its merger with tiny, privately held TotipotentRx (handing more than 40% of the company to Toti's owners), ThermoGenesis (KOOL) announced results for last quarter. Revenues were down once again (-6%) as expenses increased (+36%), while gross margin declined to 40%. CFO Bessey declared the company "pleased." In further news shareholders might have judged material leading up to the merger vote, the company revealed that Toti's Indian application for a Phase Ib trial in myocardial infarction must be resubmitted, imposing at least a 7-month delay on trial launch as re-named Cesca Therapeutics continues to bleed cash (quarterly net loss $1.6 million; up 184%).
ThermoGenesis/TotipotentRx Merger Approved
Feb 13, 2014
ThermoGenesis (KOOL) shareholders approved the company's merger with TotipotentRx, a purveyor of stem cell treatments in India, to form Cesca Therapeutics.
Pluristem Phase 1/2 Muscle Repair Trial Meets Efficacy Goals
Jan 22, 2014
Israel's Pluristem (PSTI) announced achievement of efficacy goals (improved muscle contraction force and muscle volume) for its Phase 1/2 trial of placental stem cells in gluteal muscle repair. With PSTI shares having risen steadily since December in anticipation, share price was little changed on the news.
ThermoGenesis Rockets on PR
Jan 22, 2014
ThermoGenesis (KOOL) shares are up 3-fold on a press release touting "statistically significant" efficacy in an unregistered, uncontrolled, single-arm, open-label Phase I trial in India of bone marrow concentrate for critical limb ischemia. The company's entire 16 million shares outstanding have changed hands twice since yesterday.
Advanced Cell Technology's CEO Departs
Jan 22, 2014
With its share price stuck below a dime for the past two years, Advanced Cell Technology (ACTC) announced the departure of its CEO, Gary Rabin, effective immediately, for a player to be named.
ThermoGenesis Merger Plans On the Ropes?
Jan 18, 2014
ThermoGenesis' (KOOL) proposed merger with little-known and unprofitable TotipotentRx looks to be meeting with shareholder resistance. In an unusual letter to shareholders last week concerning the ongoing vote to approve the merger (ending Feb. 13th) the company states "If you have previously voted against the merger, Thermogenesis management would like to talk to you and ask you to re-evaluate your vote," suggesting that early returns are highly unfavorable.
More Trial Tribulations for Neuralstem
Jan 7, 2014
Without public discussion, Neuralstem (CUR) extended the completion date of its Phase 1 spinal cord injury clinical trial by 2+ years, earning a rare red-flag downgrade from our Monitor. This follows on the heels of a downgrade for its Phase 2 ALS trial in December.
Cytomedix Cuts Stroke Trial Enrollment by 52%, Closes Recruitment
Jan 6, 2014
Claiming a blinded interim analysis indicates its RECOVER-Stroke trial is adequately powered with just 48 existing patients (out of 100 originally planned), Cytomedix (CMXI) announced the early closure of recruitment. The company expects to announce top-line results in May. Last September it announced its intention to divest its stem cell therapeutic programs, which it acquired from Aldagen in 2012. Cytomedix "will continue to support the clinical study manufacturing requirements of the ongoing National Heart, Lung, and Blood Institute (NHLBI) sponsored Phase 2 PACE study in peripheral arterial disease," the cost of which is borne by NHLBI.
Capricor Lands $13M Collaboration with Janssen, Gives Option to License Worth $325M
Jan 6, 2014
Capricor (CAPR) announced a manufacturing collaboration for its CAP-1002 allogeneic cardiac stem cells with Johnson & Johnson family member, Janssen Biotech, which will pay Capricor $12.5M up front. Janssen earns an exclusive option to license CAP-1002, worth a potential $325M plus royalties. CAPR shares were up nearly 30% on the announcement.
Baxter Giving Up on Phase 3 Stem Cell Trial?
Dec 23, 2013
The latest record update for Baxter's (BAX) high-profile Phase 3 trial of unexpanded autologous CD34+ stem cells for myocardial ischemia suggests the company is throwing in the towel on this trial. With just two thirds of its anticipated 444 patients recruited, the trial's status has changed from "Recruiting" to "Active, Not Recruiting," all three Canadian sites were deleted, and all 41 U.S. sites' names were expunged. A local newspaper report claims "Baxter has suspended all future candidates to stem cell heart injections for UCLA." This follows the termination/withdrawal from this trial of 4 other sites since August. As of press time the company has issued no discussion.
Athersys Completes Enrollment in Ulcerative Colitis Trial; Results Pending
Dec 19, 2013
Athersys (ATHX) and partner Pfizer announced completion of patient enrollment in their Phase 2 trial of MultiStem cells for ulcerative colitis. The trial, initiated in 2010, has weathered numerous recruitment-associated delays, but now looks to report its eagerly awaited results "in the second quarter of 2014."
Two Stem Cell Companies Join NASDAQ Biotech Index, One Departs
Dec 16, 2013
As part of its annual re-ranking process, NASDAQ OMX Group announced that two SCSI component companies -- bluebird bio (BLUE) and Cellular Dynamcis International (ICEL) will be added to its NASDAQ Biotechnology Index and one, Cytori Therapeutics (CYTX), will be retired.
ThermoGenesis Faces Loss of NASDAQ Listing
Dec 14, 2013
Troubled ThermoGenesis (KOOL), whose share price has plunged more than 50% since announcing its intention to merge with privately held TotipotentRx, received warning from NASDAQ that it faces delisting for failing to maintain the required $1 minimum share price. The company has 180 days to regain compliance, but investor displeasure over management performance may complicate this.
Another Setback for Miltenyi's Autologous CD133+ Cardio Trials
Dec 10, 2013
A recent change to the ClinicalTrials.gov record for Miltenyi Biotec's (not a SCSI component company) Germany-based trial of autologous CD133+ stem cells for myocardial infarction indicates the trial's anticipated primary completion date has been moved back a full year (to Dec. 2014). The change follows the early termination last week of a similar Miltenyi-sponsored trial in the U.S., perhaps signaling systemic patient recruiting problems for Miltenyi's autologous stem cell trials program.
Mixed Signals and a Downgrade for Neuralstem Phase 2 ALS Trial
Dec 6, 2013
NeuralStem's (CUR) CEO claims a six-month follow-up period for patients in its Phase 2 ALS trial, but the trial's record states 24 months. Either way, with the first patient treated in September and recruiting still underway, the trial's anticipated primary completion date (2/2014) is unfeasible. That, plus sites' status change from "active, not recruiting" back to "recruiting," leads our Monitor to downgrade the trial from green- to yellow-flag status.
Best of Times, Worst of Times
Dec 6, 2013
Despite an encouraging start, 2013 is shaping up to be a down year for stem cell stocks. As the year draws to a close, SCSI component stocks currently at or near their lows for the year-to-date (BCLI, ISCO, KOOL, ACTC, ASTM, STEM) greatly outnumber those at or near their highs for the year (ATHX, CUR). This analysis excludes newcomers Bluebird, Cellular Dynamics, Fate, and Capricor.
Miltenyi Terminates Trial of Autologous CD133+ Cells For CABG
Dec 4, 2013
Miltenyi Biotec (not a SCSI component) terminated its Phase 1 trial of autologous CD133+ bone marrow cells in a hoped-for 23 patients receiving coronary artery bypass grafts at the Univ. of Pennsylvania, citing "lack of recruitment." The FDA-regulated trial, registered a year ago, was scheduled for completion this coming January. The company made no formal announcement, but changed the trial's ClinicalTrials.gov record's status to "terminated."
Capricor Therapeutics Completes Merger, Joins SCSI
Nov 22, 2013
Capricor Inc., developer of allogeneic cardiac stem cells for acute myocardial infarction, announced completion of its reverse merger with Nile Therapeutics. Following its 1-for-50 reverse stock split, the new Capricor Therapeutics will trade under the OTC Markets symbol NLTXD initially, changing to CAPR on Dec. 20th. Capricor Therapeutics thus becomes the 18th and newest component of the SCSI.
ThermoGenesis Q1 Performance Continues Decline As Share Price Wilts
Nov 14, 2013
ThermoGenesis (KOOL) announced Q1 results reflecting continuing decline. Revenues were down 12% as the impact of terminating GE's distributorship took hold. Operating expenses were up nearly 500% due to mounting legal expenses and a previous product line sell-off. Net loss was $2.3M, versus income of $1M last year. The company ended the quarter with less than 9 months cash. KOOL shares have declined nearly 50% since mid-July when the company proposed a merger with little-known and unprofitable TotipotentRX.
Post-IPO, Cellular Dynamics Q3 Revenues and Loss Both Up
Nov 14, 2013
On the heels of its successful July IPO, Cellular Dynamics International (ICEL) announced Q3 revenues up 108% while its net loss widened by 36%, despite a 79% gross margin. The company had 142 customers in the past 12 months, 10 of which accounted for two thirds of total revenue.
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