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43 companies, 1 interpreter! Insight, foresight
and recommendation 

Roll Call

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Aduro (ADRO) – ADRO started January’18 priced at $7.60, slipping February 1st to $6.25 with 2/16 reflecting a pricing of $6.05 ... with three distinct immunotherapy technologies and VERY early  although ADRO has development and commercialization agreement with Genmab to evaluate five bispecific antibody product candidates targeting immune checkpoints; and collaboration agreement with Janssen Biotech, Inc. and Merck th redeeming factor.

Buy

Adverum Biotechnologies (ADVM -  January '18 opened at $3.65 rolled up to $7.70 on February '18.  After a $69 M offering of 10.22 M shares priced at $6.75 financing ... it's all about milestones and waiting for the news of catalysts.

 

Hold

Applied Genetics Technology Corporations (AGTC) In Q1/16, AGTC has clinical trial timing issues and spending woes – until clinical results are announced which are slow due to enrollments ...

Hold

Asterias Biotherapeutics (NYSE MKT: AST) -  January'18 opened at $2.15, dropping to $2.00 on February 1 yet returning to $2.10 on 2/16 ... 2018 could bring some milestones

Buy

Athersys (ATHX) – Started 1/18 at $1.81, dropping on 2/1 to $1.76 and was trading at $1.44 on 2/16 ... after initiating a follow-on equity facility to a current facility. Under the new agreement, ATHX has the right to sell up to $100 million of its common stock to Aspire Capital under certain conditions over a three-year period. In conjunction with the new facility, Aspire made an initial investment of $1 million at a price of $2.00 per share.  As of 12/31/17t, ATHX had approximately $29.3 million of cash and cash equivalents available to fund operations. DON’T look for follow through appreciation as the stock based debt facility will be selling shares into ANY strength …

Hold

AxoGen, Inc. (AXGN) –  January '18 opened at $27.95 with an upside of $28.05 on 2/1 while dropping to $27.40 on 2/16 ... since November of '17 appreciation has withstood mild drags to the downside ...

Buy

Brainstorm Cell Therapeutics (BCLI) – January '18 openaed at $3.65, dropping in February to $3.45 and continuing to drop to $3.10 on 2/12 and $3.19 on 2/16. Even with their on-going trial, I have a problem with theor corporate transparency ... tey revolve on news and the pricing falls back ...

Hold

Bellicum Pharmaceuticals (BCLM) -  January '18 opened at $9.23, slipping to a low of $6.80 on 1/31 flowed by 2/1's $5.87 yet jumping to $6.60 by 2/16. After the KITE and JUNO acquisitions, many percieve that BLCM could be percieved as an appreciator in 2018 ... We do NEED to remember; the U.S. FDA placed a clinical hold on its lead product candidate BPX-501 that's being assessed as an adjunct T-cell therapy administered after haploidentical hematopoietic stem cell transplant. The hold reportedly stems from three cases of potentially treatment-related encephalopathy (abnormal brain function) that occurred during an ongoing trial. BLCM's shares were down 1/31/18 by 33.5% on heavy volume in response to this news.

Buy

BioLife Solutions (BLFS) – Opened 2018 at $5.96, droppen into February at $5.33, seeing a low of $4.73 yet was trading up at $5.33 on 2/16 after the usual response to news. BLFS on 2/13/18 ... BLFS executed an OEM agreement to supply its CryoStor cell freeze media and HypoThermosol cell storage and shipping media under private label to MilliporeSigma, the life science business of Merck KGaA, Darmstadt, Germany.

Buy

bluebird Bio (BLUE) – BLUE has been on a tear since 8/21/17 with some dips as January opened at $181.90 with a 1/9 low of $169.50; jumping 2/1 to $205.25 slipping to $191.50 on 2/09 with a pricing of $213.25 on 2/16 ... WHO can argue with this momentum. Celgene's (CELG) option and ownership is a solid foundation ... yet, why any buy-out at this price? It will dip, slip and return but, ebb over time ... yet worth "playing" the pains and gains

Sell

Biostage (BSTG) -  The implementation of this reverse stock split will continue CEO McGorry’s “abuse and destruction of the shareholder value due to his mismanagement, misdirection and misdeeds”. It’s all about salary and “bennies” continuance, violations of fiduciary omittance and having condoned and ignored employee – male and female harassment.” And if that isn’t enough … Is Biostage (BSTG) a Ponzi or Pyramid scheme or a combination of both …? A $300 K down payment and $4 M buys a shell from which $30 M was wasted and a $47 M deficit created … 

Sell

BioTime, Inc. (BTX) -- open 1/1/18 at $2.29, rolled to $3.05 by 2/1 but, has been slipping to $2.60 on 2/16. Needs news and differentiation of the story and the definition of their multiple markets addressed ... also rolls with news yet a complacent stock ...

Hold

Capricor (CAPR)  --January started out at $1.57 with a high of $1.70 beginning February at $1.83. a high of $2.00 on 2/15 dropping to $1.85 on 2/16 … CAPR desperately NEEDS to re-finance, be ready for depreciation and dilution -

Sell

Caladrius (CLBS) --  Started 2018 at $3.70, saw a high of $4.30 dropped on February 1 to $4.12 and has been dribbling between 2/7 to 2/16 at $3.93. CLBS with all that cash from PCT's sale to Hitachi has basically done NOTHING to enhance their perception or performance ... waiting for SOMETHING actionable ...

Hold

Cellectis (CLLS) – Opened 2018 at $29.90, saw a high of $33.33; February opened at $31.01, slipping to $28.87 and regaining its altitude at $32,65 on 2/16. One key factor for 2018, The US has granted (2/13/18)  Cellectis two patents to deploy a technology known as CRISPR in T cells, which play a key role in the immune response to cancer, the company said on Tuesday. The patents come on the back of another granted last year by the European Patent Office. CLBS intended to make the three patents available for future licensing deals. The gene therapy sector has generated fierce patent disputes in recent months, as well as merger and acquisition activity.

Buy

Neuralstem (CUR) --  2018 openat at 42.03, slipped to 1.65 as February opened with a low of $1.52 and closed 2/16 at $1.63 ... a relatively flat to lowering chart. What's to watch?

Hold

Cytori (CYTX) –  Started the year seeking "strategic alternatives" with a share priced at $0.29, seeing a couple of highs of $0.47 with a 2/1 value of $0.40 which has been dropping and currently (2/16) at $0.32. A sory of missed oppurtunity thrown at the feet of its CEO ... incremental development news are minimal ... it's all about whether the FDA requests ... MORE data and trial. 

Hold

Fate Therapeutics (FATE) –  Two wordds - "on fire" having started 2018 at $6.30, saw a high of $9.39 and started February at $9.33 with a low of $7.85 jumping to $8.76 on 2/16 ... as investors kept the momentum going. It’s still in the earliest stages of development, but FATE has taken a shotgun approach to immunotherapy and cell therapy. It starts with induced pluripotent stem cells, which are then coaxed to transform into various immune cells, including natural killer cells (NKs), T-cells, and CD34+ cells. The idea is to create an off-the-shelf cellular immunotherapy production platform using stem cells. Despite the euphoria at the moment, the company's future will be determined in the clinic -- and there's a long way to go. One of MY favorites, it will twitch with dips ... near term - time will tell if it's a winner, I'd BET on this "horse" although many sessions will not stay in the gate.

Buy

Fibrocell Science (FCSC)  has always been (to me) a disappointment. January '18 opened at $0.69, rolled barely up and slightly down to open 2/1 at $0.66 and sliding into second base at $0.67 on 2/16 ...Still early with a submission of an IND Application with the U.S. FDA for FCX-013, the Company’s gene therapy candidate for the treatment of moderate to severe localized scleroderma.   

Hold

Histogenics (HSGX) --  Opened 2018 at $2.07, saw some ups at $2.92; opened February at $2.79 falling with a low of $2.50 to close 2/18 at $2.63.HSGX closed (1/25) its registered direct offering of 2,691,494 shares of its common stock, which includes 351,064 shares sold in connection with the exercise in full by the underwriter of its option to purchase additional shares. The total net proceeds of the offering are approximately $5.9 million after deducting the underwriting discounts and commissions with a solid book-running manager Canaccord Genuity. Another favorite ...

Buy

ImmunoCellular Therapeutics (IMUC) --   Always a disappointment having oipened 1/2 at $0.34, cresting to $0.25 on 2/1 closing 2/16 at $0.24. Just another day traders toy ... it's also still in a research mode - stay away.

Hold

Cesca Therapeutics (KOOL) – January '18 opened at $3.10 and it's beed downhill until February at $2.75 with some upside to $2.95 on 2/16. NOT a believer ...

Sell

MiMedx Group (MDXG) – opened 2018 at $12.98, trooped in February to $17.13 and dropped to $8.75 with a slight rebound to $9.00 on 2/21 after 2/20's shares  were halted in premarket trade on news that the company is delaying the release of Q4/17 and full-year ‘17 earnings to conduct an accounting review. The audit committee has hired legal and accounting advisers to conduct an internal investigation of allegations relating to sales and distribution practices..Executives are reviewing the accounting treatment of certain distributor contracts, among other items. "The company believes, based on information available to date, that the outcome of such investigation should not have a material impact on revenue guidance for 2018," said a statement. The company had about $33 million in cash and cash equivalents at year-end and has no debt. Shares have gained 75% in the last 12 months through Friday. Amid buzz is a short seller’s visit by the FBI, MDXG has been involved in a nasty relationship with short sellers that recently took a turn for the worse. Now, MDXG’s internal investigation is delaying the release of its financial results, including its annual statement that would detail last year’s performance - a serious hiccup yet still will be a performer after the clean-up

Buy

Mesoblast (MESO) – January '18 opened at $5.84, slipping in february to $5.50 yet falling to a low of $4.91 followed by an upswing to $5.52 on 2/21. Volume has been low as has platform news. MESO ended the recent quarter with $62.9M. Mesoblast also has a $90M equity facility that can be used over the next two years. Trials include: GVHD, MSC-100-IV: The open-label P3 trial in pediatric patients with steroid-refractory acute GVHD is expected to complete enrollment in 4Q17, with the primary endpoint data (day 28 readout) in 1Q18, followed by day 100 survival data in 2Q18. Heart failure (HF), MPC-150-IM: The P3 study in class II-III HF has enrolled over 400 patients and is on track to complete enrollment (N=600) in 2H18. The P2b study in end-stage HF (Class IV) completed enrollment (N=159) in 3Q17 with data readouts expected in 1Q18 and 3Q18. Disc Degeneration (DD), MPC-06-ID: The P3 (N=360) study is expected to complete enrollment in early 1Q18. The study is evaluating durable pain reduction and functional improvement (aiming for similar results observed in the N=100 P2 study). Rheumatoid Arthritis (RA), MPC-300-IV: Data in the P2 study demonstrated durable efficacy in anti-TNF refractory patients going out to 52 weeks. The totality of the data will be used to design a P3 program, though timing has not been disclosed. Mesoblast's strong IP estate has to be better valued … 

Buy

Spark Therapeutics (ONCE) --   Opened 1/18 at $53.31, slipped to $50.56 (1/5) ending the month at $56.05 and started February at $56.30 and has been slippin, dipping and retesting lows such as 2/20's $50.23 a believer. ONCE has built a fully integrated company dedicated to discovering, developing and delivering one-time treatments that provide long-lasting, transformative outcomes to patients, families, society and the health care system. In 2018, ONCE is focused on launching LUXTURNA in the U.S. and securing marketing authorization in the EU, advancing its global development program for SPK-8011 in hemophilia A and also continuing to progress its pipeline of other investigational gene therapies. Recent: entered into an amendment to the license agreement for SPK-9001 with Pfizer (PFE), in 11/17; including an initial $10 million cash payment and up to an additional $15 million in potential milestone payments upon completion of certain transitional activities in mid-2018 and also ntered into a supply agreement with PFE in February 2018 to begin production this quarter for one batch of drug substance expected to be used for Phase 3 development; Spark received $7 million up front and will receive up to $7 million upon delivery. Dips are always due to market conditions but, with $540.2 M in cash excludes the $105 million received from Novartis in 1/18 and is eligible to receive an additional $25 million upon approval by European Medicines Agency (EMA) and total of $40 million in aggregate additional milestones on initial sales in multiple ex-U.S. markets

Buy

Organovo Holdings (ONVO) ONVO  opened on 1/2/18 at $1.39, floating to $1.45 by 2/1 and slipping to $1.05 by 2/12. A show me stock ... the FDA recently granting orphan designation for our NovoTissues® treatment of Alpha-1 antitrypsin deficiency (“A1AT”), our path to commercializing this therapeutic comes with significant developmental and economic incentives.  With few alternative therapies and a high annual cost of care, patient need is great in treating this rare, debilitating liver disease.  ONVO has also begun new studies in a second therapeutic indication within the category of inborn errors of metabolism, Fumarylacetoacetate Hydrolase (“FAH”) deficiency, and look forward to reporting proof-of-principle data in Q2-3/18. A show me stock

 

Hold

Osiris Therapeutics (OSIR) – Late Filing,  SEC issues, officer crimminal indictments and yet another COO departs (number 5 in four years?). Started the year 2018 at $6.15, dived and jived to $6.95 by 2/1 and achieved $9.08 by 2/21. Once their "clean" it will be worth a near term topic until then "play" monopoly with the shares ... NO trust

Hold

Pluristem (PSTI) – Opened 2018 at $1.44, saw a high of $1.61 and started 2/1 at $1.47 with 2/21 having slipped to $1.38.  News is always an appreciator that is never followed through ... PSTI needs to refine its communication to shareholders and operates on assumptions. With $36M of cash on hand and pivotal studies (three) being paid for by grants, estimates assume a quarterly cash burn rate of $8M – I am still a critic expecting data readouts from three of its clinical programs in 2018. Traders "play" the shares - too often ...

Hold

Stemline (STML) -- STML opened on 3/1/16 at $4.89 and closed on 3/31 at $4.66.  This follows February’s open at $5.01 and January’s at $6.23.  On 3/14, STML reported FY/15 earnings that showed its loss widened to $37.2 M, or $2.15 per share. Revenue was reported as $654 K.  Shares in STML have dropped 16% since the beginning of the FY16 and have dropped 67% in the last 12 months.  Recommendation:  HOLD

 

 

Hold

Vericel (VCEL) – During Q1/16, VCEL received U.S. Food and Drug Administration (FDA) approval of its Epicel Humanitarian Device Exemption (HDE) supplement, which revised the Epicel label to include pediatric patients and specify the probable benefit, mainly related to survival, for adult and pediatric patients.  It allows VCEL to sell Epicel for profit on up to 360,400 grafts per year.  During the quarter, VCEL also submitted a Biologics License Application for MACI for the treatment of cartilage defects of the knee, which was accepted for review by the FDA with a PDUFA goal date of January 3, 2017.  VCEL also entered into a $10 M credit facility and $5 M term loan agreement with Silicon Valley Bank to access low-cost, non-dilutive capital.  VCEL reported a Q1/16 net loss of -$2 M or -$0.08 per share, compared to a Q1/15 net loss of -$4.5 M, or -$0.19 per share.  RECOMMENDATIONBUY

Buy

Verastem (VSTM) --   In March 2016, VCEL announced a clinical trial collaboration agreement with Pfizer (NYSE: PFE) and Merck (NYSE: MRK) to evaluate the combination of VSTM’s focal adhesion kinase (FAK) inhibitor VS-6063 and PFE /MRK’s anti-PD-L1 immunotherapy avelumab. VSTM previously reported initial signs of clinical activity in patients with ovarian cancer when VS-6063 is used in combination with paclitaxel. Under the terms of the agreement, the parties will conduct a planned P1/1b clinical trial evaluating escalating doses of the combination of VS-6063 and avelumab as a potential treatment option for patients with advanced ovarian cancer.  VCEL reported a Q1/16 net loss of -$8.3 M or -$0.22 per share, compared to a Q1/15 net loss of -$15.2. M, or -$0.46 per share.  RECOMMENDATIONBUY

Buy

VistaGen (VTGN) – On 5/11/16, VTGN’s common stock began trading on NASDAQ under the symbol ‘‘VTGN”.  VTGN also announced pricing of its public offering of 2,352,942 shares of common stock and warrants to purchase up to 2,352,942 shares of common stock, at a combined price of $4.25 for aggregate gross proceeds of approximately $10.0 M. The warrants will have an exercise price of $5.30, are exercisable immediately, and will have a term of five years.   RECOMMENDATION:  BUY

Buy

Intrexon (NYSE: XON) – During Q1/16, XON’s subsidiary Oxitec announced receipt of a special temporary registration from the National Health Surveillance Agency of Brazil (Anvisa) to deploy its genetically engineered mosquito, OX513A, known as 'Friendly Aedes aegypti', throughout the country. The World Health Organization's Vector Control Advisory Group also issued a positive recommendation for planned pilot deployment of Oxitec's self-limiting mosquito (OX513A) under operational conditions.  Additionally the Pan American Health Organization offered to provide technical support for pilot studies of OX513A as part of its response to the Zika epidemic.  In the United States, the U.S. Food and Drug Administration (FDA) Center for Veterinary Medicine published a preliminary finding of no significant impact (FONSI) on Oxitec's self-limiting OX513A Ae. aegypti mosquito for an investigational trial in the Florida Keys.  Finally, the Cayman Islands Mosquito Research and Control Unit (MRCU) plans to utilize Oxitec's solution for suppression of wild populations of Ae. aegypti to help reclaim the island from this disease-carrying pest.  The program follows a successful trial of Oxitec's mosquito in the Cayman Islands that reduced Ae. aegypti by 96%.  XON reported a Q1/16 net loss of -$65.3 M or -$0.55 per share, compared to a Q1/15 profit of +$25.8 M or +$0.26 per share.  RECOMMENDATIONBUY

 

Buy