May 9, 2016 7:01pm
The iShares Nasdaq Biotechnology ETF (IBB) traded more than 2.6% higher.
Pre-open indications batting average: 1 hit and 0 miss
Companies mentioned: BTX, CLLS, NWBO, PSTI and QURE
Earnings reported: AAVL, AGTC, BLCM, CUR, FATE, JUNO, KITE, STML and VSTM
Do you care what happened today, you should … because it has implications to Tuesday's sector activity?
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There is one thing that everyone needs, and that's interpretation and translation of intelligence, not just news or information - we get too much!
- To that end, I report a matrix of variables designed for investor’s consideration concerning the stem, cell and gene therapy regenerative medicine portfolio to track and monitor its pricing metric;
The takeaway is that investor need to decide what actions to take, or not take, based on their specific situation.
U.S. stocks closed mixed in high volume trade Monday, with gains in health care offsetting declines in materials and energy as oil prices fell.
The NASDAQ closed UP +14.05 or +0.30% to 4,750.21 and the DOW closed DOWN -34.72 or -0.20% to 17,705.91.
A day in the life of the stem, cell and gene therapy RegMed (SCGT & RM) sector – the advance/decline line scenario of our 43 covered companies.
- Opened positive with an A/DL of 23/17 and 3 flats;
- The mid-day stayed negative with an A/DL of 29/13 with 1 flat;
- The closing bell rang positive with A/DL of 26/14 with 3 flats
Henry’omics:
Stocks opened to the upside, staying positive to the mid-day and close positive.
The iShares Nasdaq Biotechnology ETF (IBB) closed nearly 2.6% higher for its best day since April 21.
A pre-open indication batting stats – 1 hit and 0 miss:
- StemCells (STEM) closed DOWN -$0.38 after a 1 for 12 reverse split – hit;
The Bottom Line:
Q2/16 is being decoded this week as Q1/16 financial results/earnings are announced!
Review my fear gauge or the CBOE Volatility Index (VIX) - dropping:
- Monday closed below 14.5;
- Friday closed below 15;
- Thursday traded at 15.9;
- Wednesday traded near 16.5;
- Tuesday traded near 15.7 – a 6.6% increase;
- Last, Monday traded near 14.8;
Out and about:
BioTime (NYSEMKT: BTX) closed UP +$0.13 to $2.81.
BTX had fallen 7.8%, the biggest move since Feb. 18, and more than quadruple its industry group. The shares fell to $2.60 from $2.82 in Friday’s session. Trading volume was 40% more than the average for this time of day. BioTime's move compares with the 1.7% drop in the Nasdaq Biotechnology Index and the 0.3% loss in the Standard & Poor's 500 Index. The stock is 65% below the Bloomberg consensus one- year target price. It returned a negative 31% so far this year and a loss of 46% in the past 52 weeks. Short interest was 35X BTX’s average daily trading and represented 14% of the shares available as of the latest quarterly filing.
Cellectis SA (CLLS) closed UP +$2.46 to $33.38
- CLLS on Friday rose 9.9% with volume at 2.7x the 3 month average. Cellectis SA said last week at a conference that a second baby with aggressive leukemia remains in remission 6 months after receiving its cell therapy, while this is not a clinical event, news is “very encouraging” as it shows the compound could be as effective as its competitors; no graft-versus-host disease phenomenon has been observed so far. CLLS’ stock has risen 17% month-to-date
Northwest Bio (NWBO) closed UP +$0.19 to $1.26.
- NWBO had announced an operations update in regard to its P1 and P2 trials, Scientific Advisory Board and NASDAQ compliance. Northwest has reached conceptual agreement with three third parties to conduct three different P2 combination trials for the treatment of three different cancers. We have seen a low of $1.07 and a high of $3.06 over the last 3 months and 2 weeks.
Pluristem Therapeutics (PSTI) closed DOWN -$0.06 to $1.56.
- Having been awarded approximately $3.3 M from the Israel Innovation Authority (IIA) - overseeing all government sponsored support of Israeli R&D – it’s basically an R&D tax credit or incentive. PSTI is required to pay royalties of 3% - 4% on sales of products and services derived from technology developed using this and other IIA grants until 100% of the dollar-linked grants amount plus interest are repaid.
uniQure (QURE)presents pre-clinical data on AAV Re-Administration, Regulated Gene Expression and Total Brain Transduction at ASGCT
- The data from several preclinical research programs focused on the development and validation of new technologies to improve gene therapy as a therapeutic approach. The results were presented in poster sessions at the American Society of Gene and Cell Therapy (ASGCT) 19^th Annual Meeting in Washington D.C. and highlight the progress uniQure has made in establishing optimized gene therapy delivery systems, re-administration protocols and vector technologies specifically in its key focus areas, liver/metabolism and CNS.
- uniQure has made several important advances in the design and optimization of gene therapy technology that we believe will significantly expand the application and overall effectiveness of our modular platform.
Earnings review:
Applied Genetic Technologies closed DOWN -$0.06 to $14.20 beating Q3 earnings expectations but, misses’ revenue forecasts.
- AGTC reported Q3/16 net income of $2 M, after reporting a loss in the same period a year earlier. On a per-share basis, AGTC had net income of $0.11 per share. The results topped “street” expectations which were for earnings of $0.04. AGTC posted revenue of $12 M, which fell short of “street” forecasts of $13.4 M. Applied Genetic Technologies shares have declined 30% since the beginning of the year. At March 31, AGTC's cash, cash equivalents and investments amounted to $180.5 M, which include payments previously received under their collaboration with Biogen (BIIB). AGTC expects that as of June 30, 2016, its cash, cash equivalents and investments will be between $163 M and $173 M. In the final minutes of trading on Monday, shares hit $14.20, a drop of 22% in the last 12 months.
Avalanche Biotechnologies (AAVL) closed DOWN -$0.11 to $4.03
- Net loss was -$15.4 M, or $0.57 per share, compared to a net loss of $9.5 M, or $0.38 per share, for Q1/15. AAVL reported Q1 results and plans to change name/ticker after closing Annapurna acquisition in Q2. The expanded pipeline will include a study of ANN-001 for A1AT deficiency, planned to begin later this year and a first-in-human study of ANN-002 for heredity angioedema, or HAE, estimated to initiate in 2017. Cash, cash equivalents and marketable securities were $247.1 M as of 3/31/16,
Bellicum Pharma (BLCM) closed UP +$0.25 to $9.41
- BLCM reported a Q1 net loss of $15.1 M, compared to a net loss of $7.8 M for Q1/15. As of March 31, 2016, cash and investments totaled $151.8 M. In March 2016, BLCM closed on a debt financing agreement that allows for borrowings of up to $30.0 M to use for the build-out of manufacturing facilities and for general corporate purposes. BLCM received initial net proceeds of $14.8 M on the closing date.
Fate Therapeutics (FATE) closed UP +$0.02 to $1.73
- Fate Therapeutics Inc. (FATE) reported a loss of $8.4 M or a per share loss of $0.29. The results fell short of “street” expectations which was for a per share loss of $0.28. FATE posted revenue of $1.3 M in the period, which topped “street” forecasts which had expectations of $842 K. Cash, cash equivalents and short-term investments as of March 31, 2016 were $55.6 M compared to $64.8 M compared to Q1/15’s end. A year ago, they were trading at $7.19.
Juno Therapeutics (JUNO) closed UP +$1.32 to $38.49
- JUNO widened its Q1 loss year-over-year, from $65 M to $71.1 M burning through more cash and recorded a bigger loss than it did this time last year’s $26.4 M in Q1/15. JUNO still has a “strong” cash position with $1.13 billion on hand as of 3/31. JUNO reported $9.8 M in Q1 revenue, which included $5.8 M in milestone payments from Novartis and $3.8 M from Celgene as part of its agreement with those companies. In after-hours trading, JUNO’s stock priced dipped nearly 4%, to $37 a share.
Kite Pharma (KITE) closed UP +$1.15 to $45.80
- KITE reported a loss of $43.9 M or a per share loss of $0.90. Losses, adjusted for stock option expense, came to $0.60 per share. The results beat “street” expectations which forecasted a loss of $1.22 per share. KITE posted revenue of $5.1 M in the period, which also topped “street” forecasts which had been expected at $4.8 M. As of March 31, KITE had $577.4 M in cash, cash equivalents, and marketable securities.
- KITE continues to expect the full year 2016 net cash burn to be $235 to $250 M, which includes approximately $20 M in capital expenditures, but excludes any inflows or outflows from business development activities. The estimated full year 2016 net cash burn is primarily driven by an estimated net loss of $295 to $310 M, which includes an estimated $80 M of non-cash stock-based compensation expense.
- Kite Pharma shares have declined 26% since the beginning of the year. Shares have decreased 18% in the last 12 months.
Neuralstem (CUR) closed UP $0.00 or +0.43% to $0.33
- After reporting a Q1/16 loss of $6.6 M with a per share loss of $0.07; cash was reported at 3/31/16 was $7.6 M. CUR had posted revenue of $2.5 M in the period. On May 6, 2016, CUR closed a 20 M share offering at $0.40 resulting in net proceeds of $7.42 M. A year ago, they were trading at $1.85.
Stemline (STML) closed UP +$0.43 to $5.51
- STML reported a Q1/16 loss of $9 M and a per share loss of $0.51 compared with a net loss of $7.7 M, or $0.46 per share, for Q1/15.The results exceeded “street” expectations. The estimate was for a loss of $0.59 per share. STML posted revenue of $206 K, also exceeding “street” forecasts of $145 K. Stemline ended 3/31/16 with $87.8 M in cash, cash equivalents and investments. STML shares have decreased 19% since the beginning of the year. The stock has fallen 62% in the last 12 months.
Verastem (VSTM) closed DOWN -$0.02 to $1.40
- VSTM reported a loss of $8.3 M or a per share loss of $0.22 as compared to a net loss of $15.2 M, or $0.46 per share in q1/15. The results beat “street” expectations for a loss of $0.32 per share. As of March 31, Verastem had cash, cash equivalents and investments of $99.5 M. Verastem used $10.8 M for operating activities during Q1 settling one-time compensation payments, severance payments and paying down accounts payable and accruals. Based on current operating plans, VSTM expects to have sufficient cash to fund R&D programs and operations into 2018. A year ago, they were trading at $8.36.
Who was leading the declines – to of the bottom 5?
- International Stem Cell (ISCO) closed down -$0.72 to $2.88;
- StemCells (STEM) -$0.37 to $2.51;
- Regenxbio (RGNX) -$0.14 to $9.89;
- Avalanche (AAVL) -$0.11 to $4.03;
- Histogenics (HSGX) closed down -$0.08 to $1.57
Who was UP – top 5:
- Spark Therapeutics (ONCE) closed +$3.18 to $35.60;
- bluebird bio (BLUE) +$2.53 to $41.05;
- Cellectis SA (CLLS) +$2.46 to $33.38;
- Juno Therapeutics (JUNO) +$1.32 to $38.49;
- Kite Pharma (KITE) closed up +$1.15 to $45.80;
Most active sector stocks + and -:
- International Stem Cell (ISCO) -20%;
- StemCells (STEM) -12.85%;
- Histogenics (HSGX) -5.13%
- Caladrius Biosciences (CLBS) -4.95%;
- Pluristem (PSTI) -3.70%
Versus …
- Northwest Bio (NWBO) +17.76%;
- Spark therapeutics (ONCE) +9.81%;
- Stemline (STML) +8.46%;
- Cellectis SA (CLLS) +7.37%;
- uniQure (QURE) +7.69%;
Who was FLAT?
- BioLife Solutions (BLFS) at $1.75;
- ReNeuron (RENE.L) at $3.50
- VistaGen (VSTA) at $7.00;
Opinions expressed are those of the author and are subject to change, and not intended to be a forecast of future events, a guarantee of future results, nor investment advice.
Whether information or intelligence is good, bad or somewhere in between; I put into context what is relevant and useful for investors. All investments are subject to risks. Investors should consider investment objectives.
Henry McCusker, the editor and publisher of RegMed Investors does not hold or have positions in securities referred to in this publication.
