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Gainers & Losers Of Mar.28: CBIO, AKER, IMMY, HTGM, PAVM...

March28 032817

The following are some of the biotech stocks that made their way onto the Day's Gainers & Losers' list of March 28, 2017.

GAINERS

1. Catalyst Biosciences Inc. (CBIO)

Gained 191.46% to close Tuesday's (Mar.28) trading at $15.01.

News: The Company has received the go-ahead from the Korean Ministry of Food and Drug Safety to conduct a clinical trial with CB 2679d/ISU30, a next-generation Factor IX drug for the treatment of patients with hemophilia B.

Accordingly, Catalyst's collaborator, ISU Abxis, plans to initiate a phase 1/2 proof-of-concept study in individuals with severe hemophilia B in the second quarter of 2017.

After phase 1/2 study, ISU Abxis has an option for exclusive commercial rights in South Korea and a profit share on ex-South Korean commercialization. Catalyst retains full development and commercial rights for CB 2679d/ISU304 outside of South Korea.

2. Diffusion Pharmaceuticals Inc. (DFFN)

Gained 81.75% to close Tuesday's trading at $4.98.

News: No news

Anticipated event:

The company's lead investigational drug is Trans Sodium Crocetinate or TCS, which is being investigated to enhance the efficacy of radiation and chemotherapy.

TSC is designed to work by safely re-oxygenating oxygen deprived (hypoxic) tissue. Hypoxia is an especially critical obstacle in the treatment of cardiovascular and respiratory diseases, as well as in cancer.

A phase II study of TCS in Glioblastoma produced encouraging results - with overall survival increasing by 37% at 2 years. An end of phase II meeting with the FDA was held in May 2015 and the company was informed that a single phase III study could serve as the basis for approval.

Diffusion Pharma expects to begin enrollment in the phase III study of TSC in Glioblastoma in the first half of this year.

The company's shares were uplisted from OTC to the NASDAQ on November 9, 2016.

3. Akers Biosciences Inc. (AKER)

Gained 67.86% to close Tuesday's trading at $2.35.

News: Akers has received an initial order for its Tri-Cholesterol "Check" test from First Check Diagnostics LLC

The Tri-Cholesterol "Check" test is disposable, uses just a finger-stick blood sample and gives a result in only 5 minutes. The test has FDA 510(k) clearance in the United States as well as a CE mark for the European Economic Area.

4. Sunshine Heart Inc. (SSH)

Gained 32.76% to close Tuesday's trading at $2.31, recouping all it lost over the past 3 trading days.

News: No news

Recent event: The Company reported Q4 and full-year 2016 financial results on Mar.2, 2017.

Net loss in Q4 2016 narrowed to $2.90 million or $4.64 per share on net sales of $746 thousand. This compared with a net loss of $6.60 million or $10.81 per share on nil sales in the year ago quarter.

The Company reduced total costs and expenses by 40% and operating cash utilization by 43% in Q4, 2016 from same quarter last year.

5. Imprimis Pharmaceuticals Inc. (IMMY)

Gained 22.61% to close Tuesday's trading at $3.85, extending its gain for the second straight day.

News: No news

Recent event: On Mar.22nd, the Company announced that it had entered into agreements with two accredited investors for a registered direct placement of 1,312,000 shares of common stock at a price of $2.40 per share for aggregate gross proceeds of $3.14 million.

The Company had record growth in the fourth quarter and for the fiscal year 2016 - reporting total revenue of $5.8 million in the fourth quarter of 2016, up 65%, and total revenue of $19.9 million in 2016, up 105% compared to the year-ago periods.

6. Osiris Therapeutics, Inc. (Pink Sheets:OSIR)

Gained 19.75% to close Tuesday's trading at $4.73.

News: The Company has completed restatement of 2014 financial statements.

It should be noted that the trading of Osiris' common stock was suspended on Tuesday, March 14, 2017 for failing to comply with the NASDAQ Listing Rule by not timely filing with the SEC its Annual Report on Form 10-K for the year ended December 31, 2015 ("2015 Form 10-K"), its Quarterly Report on Form 10-Q for the quarter ended March 31, 2016 ("Q1 2016 Form 10-Q") and its Quarterly Report on Form 10-Q for the quarter ended June 30, 2016 ("Q2 2016 Form 10-Q"), respectively.

Now that it has completed restatement of 2014 financial statements, the Company's next move will be to apply for relisting of its common stock on NASDAQ once all the SEC filings are current.

Osiris also announced today that it expects to report product revenue of $89 to $92 million for 2015 and $110 to $114 million for 2016. In its November 7, 2016 press release, the Company had announced estimated ranges of product revenue of $85 to $90 million for 2015 and $100 to $110 million for 2016.

7. Selecta Biosciences Inc. (SELB)

Gained 17.28% to close Tuesday's trading at $13.98.

News: New data from the Company's ongoing phase II study of SEL-212 shows persistent clinical activity after repeat administration in symptomatic gout patients.

SEL-212 consists of proprietary SVP-Rapamycin, which is dosed in combination with the potent uricase called Pegsiticase that the Company has in licensing.

In the ongoing phase II study, patients are being enrolled in multiple ascending dose cohorts to identify the optimal dose ratio of SVP-Rapamycin and pegsiticase, the minimal effective dose level of SEL-212 for repeat monthly administration, and the dose regimen to take forward into phase III.

The recruitment for two higher dose cohorts of patients began in March 2017, and the company plans to provide the data update in May, and present initial data from this trial at a medical meeting by the end of June 2017.

8. Matinas BioPharma Holdings Inc. (MTNB)

Gained 15.69% to close Tuesday's trading at $2.95.

News: The Company will ring the NYSE closing bell on March 29th, 2017.

Recent event: On Mar.27th, the Company reported positive top-line data from its phase 1 single-ascending dose study of MAT2501 in healthy volunteers.

MAT2501 is a lipid-crystal nano-particle formulation of Amikacin, under development for Gram-negative bacterial infections.

After meeting with the FDA, Matinas plans to initiate a phase II study of MAT2501in patients with non-tuberculous mycobacterium (NTM) lung disease refractory to guideline therapy.

Near-term catalyst:

- A phase IIa study of Matinas' lead anti-infective product candidate, MAT2203, in chronic mucocutaneous candidiasis is underway, with top-line data expected to be reported in 2Q 2017.

9. KemPharm Inc. (KMPH)

Gained 12.79% to close Tuesday's trading at $4.85.

News: No news

Near-term catalysts:

- Initiate additional pharmacokinetic studies with KP415 for the treatment of ADHD in the first half of this year.
-- Report additional pharmacokinetic study data of KP415 in the second half of this year.
-- Human clinical trials of KP201/IR for the short-term treatment of acute pain are anticipated to commence in 1H 2017 - with final intranasal human abuse liability (HAL) study data expected in the second half of this year.
-- NDA submission for KP415 for the treatment of ADHD is planned for 2018.

10. ImmunoCellular Therapeutics Ltd. (IMUC)

Gained 12.63% to close Tuesday's trading at $3.30.

News: No news

Near-term catalyst:

-- Preliminary data from phase I open-label trial of ICT-121 in recurrent glioblastoma expected in June 2017.

11. CRISPR Therapeutics AG (CRSP)

Gained 11.95% to close Tuesday's trading at $20.42.

News: The European Patent Office (EPO) has announced its intention to grant a patent broadly covering the Company's in-licensed gene editing technology known as CRISPR.
CRISPR, which stands for "clustered regularly interspaced short palindromic repeats," is an advanced genetic engineering technique.

The patent covers CRISPR/Cas9 single-guide gene editing system for uses in both non-cellular and cellular settings, including in cells from vertebrate animals such as human or mammalian cells - as well as composition claims for use in any setting, including claims for use in a method of therapeutic treatment of a patient, noted the Company.

LOSERS

1. Cellect Biotechnology Ltd. (APOP)

Lost 23.85% to close Tuesday's trading at $8.30. A pullback after yesterday's gain of 74%.

Recent event: On Mar.27th, the Company announced that its first stem cell transplant procedure was successfully performed using its ApoGraft technology in its phase I/II clinical trial in a blood cancer patient.

The independent Data and Safety Monitoring Board (DSMB) has given the go-ahead for enrolling additional 2 cancer patients for ApoGraft transplantation treatments.
ApoGraft aims to become a game changer in stem cells transplantations for cancer treatments.

2. HTG Molecular Diagnostics Inc. (HTGM)

Lost 23.56% to close Tuesday's trading at $7.30. After touching a 52 week high of $13.25 during intraday trading on Mar.24th, 2017, the stock has been giving back its gains.

News: No news

3. Cancer Genetics Inc. (CGIX)

Lost 19.80% to close Tuesday's trading at $4.05. A pullback after yesterday's gain of 29.49%.

News: No news

Recent event: On Mar.23rd, the Company reported record revenue for the fourth quarter and full-year 2016.

Fourth quarter revenues were up 32% year-over-year on strong organic growth to $7.2 million while full-year 2016 revenues were up 50% year-over-year to $27 million.
Net loss improved to $2.8 million or $0.15 per share during the fourth quarter of 2016 compared to a net loss of $5.7 million or $0.48 per share during the fourth quarter of 2015.

During 2017, the Company expects its business to continue high double-digit, durable growth.

4. PAVmed Inc. (PAVM)

Lost 16.36% to close Tuesday's trading at $5.01.

News: The Company has filed a registration statement on Form S-1 with the SEC relating to private placement

Near-term catalysts:

The Company's initial product candidates are PortIO, an implantable vascular access device, and CarpX, a percutaneous carpal tunnel device, among others.

-- PAVmed expects to begin commercialization of PortIO next quarter and CarpX in Q3, 2017.

5. Galectin Therapeutics Inc. (GALT)

Lost 12.88% to close Tuesday's trading at $2.03.

News: The Company reported 2016 financial results and provided business update.

For the year ended December 31, 2016, the net loss applicable to common stockholders was $22.4 million or $0.76 per share, compared with a net loss applicable to common stockholders of $21.1 million or $0.88 per share in 2015. The increase is largely due to higher research and development expenses primarily related to the Phase 2 clinical program.

Near-term catalyst:

- A phase 2b trial of GR-MD-02 in NASH cirrhosis, dubbed NASH-CX, is underway, with top-line data readout remaining on track for early December 2017.

6. MannKind Corp. (MNKD)

Lost 10.44% to close Tuesday's trading at $1.63.

News: No news

Recent event: On March 16th, 2017, the company reported Q4 and full-year 2016 financial results.

Net income in Q4, 2016 was $53.98 million or $0.56 per share on total net revenue of $12.40 million. This compared with a net loss of $277 million or $3.30 per share on nil revenue in the year-ago quarter.

7. Reata Pharmaceuticals Inc. (RETA)

News: No news

Near-term catalysts:

The Company's lead product candidates are Bardoxolone methyl and Omaveloxolone.

- A phase III trial of Bardoxolone methyl for the treatment of pulmonary arterial hypertension, or PAH, associated with connective tissue disease, or CTD-PAH, dubbed CATALYST, is underway. Data from CATALYST are expected to be available during the first half of 2018.
- Bardoxolone methyl is also being studied in a phase II trial, known as LARIAT, for the treatment of pulmonary hypertension due to interstitial lung disease, or PH-ILD.
- A pivotal phase II/III trial of Bardoxolone methyl, known as CARDINAL, for the treatment of chronic kidney disease, or CKD, caused by Alport syndrome, is also ongoing. The phase II data is expected by the end of 2017.

Omaveloxolone is under two phase II studies - one in the indication of Friedrich's ataxia, dubbed known as MOXIe, and the other in mitochondrial myopathies, known as MOTOR. Each trial consists of two parts.

- Data from the first part of MOXIe and MOTOR are expected mid-year 2017 and the second-half of 2017, respectively.
- A phase 1b/2 trial, known as REVEAL, to evaluate Omaveloxolone in combination with existing immunotherapies for the treatment of metastatic melanoma is also ongoing.
Data from the 1b dose escalation portion of REVEAL are expected during the second half of 2017.

8. Atara Biotherapeutics Inc. (ATRA)

Lost 9.07% to close Tuesday's trading at $18.55.

News: No news

Near-term catalysts:

- Initial data from the Company's phase I trial of autologous version of ATA188 in patients with primary and secondary progressive multiple sclerosis to be presented by its collaborating investigators at a medical conference in late April.
- Atara Bio plans to initiate a Phase 1 trial of allogeneic ATA188 in patients with multiple sclerosis in the second half of 2017.

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