ZYNE Shines, VBLT On Track, CALA Continues To Get Crushed

(RTTNews) - The following are some of the biotech stocks that made their way onto the Day's Gainers & Losers' list of November 14, 2017.

GAINERS

1. Zynerba Pharmaceuticals Inc. (ZYNE)

Gained 11.07% to close Tuesday's (Nov.14) trading at $13.45.

News: The Company provided an overview of its operations and reported its third quarter financial results.

Net loss for the third quarter ended September 30, 2017 was $8.31 million or $0.63 per share compared to a net loss of $5.98 million or $0.67 per share in the year-ago quarter. No revenue was generated in the two comparable quarters.

Near-term catalysts:

-- Initiate a pivotal phase III trial of ZYN002 Cannabidiol (CBD) gel in pediatric and adolescent Fragile X Syndrome patients in the first half of 2018. -- Initiate a pivotal Phase 2/3 program of ZYN002 CBD gel in adult Osteoarthritis patients in 2018. -- Results from phase I program for ZYN001 pro-drug of Tetrahydrocannabinol (THC) delivered via transdermal patch in healthy volunteers are expected in the first half of 2018. ZYN001 THC pro-drug patch is being developed for fibromyalgia and peripheral neuropathic pain.

2. Vascular Biogenics Ltd. (VBLT)

Gained 10.13% to close Tuesday's trading at $8.70.

News: The Company reported third quarter 2017 financial results and provided a corporate update.

The comprehensive loss for the quarter ended September 30, 2017 widened to $6.5 million or $0.24 per share from $3.2 million or $0.12 per share in the year-ago quarter. No revenues were reported in the comparable quarters.

Recent event:

-- On November 6, 2017, the Company signed an exclusive license agreement with NanoCarrier Co., Ltd. for the development, commercialization, and supply of VB-111 in Japan.

Vascular Biogenics received an up-front payment of $15 million, and is entitled to receive more than $100 million in development and commercial milestone payments. In addition, it will receive tiered royalties on net sales in the high-teens.

Near-term catalysts:

-- Initiate a phase III study of VB-111 in ovarian cancer by year-end 2017. -- Top-line results from phase III study of VB-111 in recurrent glioblastoma, dubbed GLOBE, are expected to be available in the first quarter of 2018.

3. Neos Therapeutics Inc. (NEOS)

Gained 8.42% to close Tuesday's trading at $10.95.

News: No news

Recent event:

-- On November 6, 2017, the Company reported third quarter 2017 financial results.

Net loss in Q3, 2017 shrunk to $16.3 million or $0.58 per share from $25.8 million or $1.61 per share for the same period in 2016. Total product revenues in the recent third quarter rose to $6.7 million from $1.6 million in the year-ago quarter.

-- PDLI BioPharma Inc.'s (PDLI) proposal to acquire Neos for $10.25 per share in cash expired on November 8, 2017.

PDL originally made public its proposal to acquire Neos on October 26, 2017. NEOS shares rose 40% that day to close at $10.05.

Near-term catalysts:

-- Launch Adzenys ER in January 2018. Adzenys ER for the treatment of ADHD in patients 6 years and older was approved by the FDA in September of this year.

4. TRACON Pharmaceuticals Inc. (TCON)

Gained 7.14% to close Tuesday's trading at $3.00.

News: The positive results from a Phase 1 clinical trial of the Company's drug candidate TRC102 plus approved chemotherapy drug Fludara in patients with advanced hematologic malignancies were published in the journal Oncotarget.

The phase 1 trial enrolled a total of 20 patients, of whom 10 had chronic lymphocytic leukemia, 3 had follicular lymphoma, 3 had diffuse large B cell lymphoma, 2 had plasma cell myeloma, 1 had mantle cell lymphoma and 1 had anaplastic large cell lymphoma.

The combination of TRC102 and Fludara produced an overall response rate of 24%, with no dose limiting toxicity, noted the Company.

LOSERS

1. Calithera Biosciences Inc. (CALA)

Lost 19.83% to close Tuesday's trading at $9.40. This is the second straight day of double-digit loss for the stock.

News: No news

Recent event:

-- On November 11, 2017, the Company reported data from its phase 1/2 study of CB-839, combined with Opdivo in patients with advanced Melanoma, Renal Cell Carcinoma, or Non-Small Cell Lung Cancer.

The overall response rate was 19% and overall disease control rate was 44% in melanoma patients. The melanoma patients were progressing on a checkpoint inhibitor at study entry.

The overall response rate was 21% in renal cell carcinoma IO naïve cohort with disease control rate of 74%.

2. Synergy Pharmaceuticals Inc. (SGYP)

Lost 16.80% to close Tuesday's trading at $2.03.

News: The Company has priced its underwritten offering of 21.70 million shares of its common stock together with accompanying warrants to purchase an aggregate of 21.70 million shares of common stock at a combined price to the public of $2.58 per share and accompanying warrant.

The gross proceeds from the offering are expected to be approximately $56 million. The offering is slated to close on or about November 15, 2017, subject to customary closing conditions.

3. Tandem Diabetes Care Inc. (TNDM)

Lost 15.49% to close Tuesday's trading at $2.51.

News: No news

Recent event:

-- On October 26, 2017, the Company reported strong third quarter financial results.

On a non-GAAP basis, sales for Q3, 2017 were $23.7 million compared to $20.7 million for the same period of 2016. Non-GAAP gross margin for the recent third quarter was 39% compared to 26% for the comparable year-ago period.

For full year 2017, non-GAAP sales are estimated to be in the range of $95 million to $100 million. Non-GAAP sales were $88.5 million in 2016.

4. Inotek Pharmaceuticals Corporation (ITEK)

Lost 14.63% to close Tuesday's trading at $2.45.

News: No news

Recent event:

-- On October 12, 2017, the Company filed with the SEC, its preliminary proxy statement related to the previously proposed combination of Inotek Pharmaceuticals and privately-held Rocket Pharmaceuticals.

Rocket shareholders are expected to own approximately 81% of the combined Company and current Inotek shareholders will own approximately 19% of the combined Company.

5. ProQR Therapeutics N.V. (PRQR)

Lost 13.67% to close Tuesday's trading at $3.00.

News: The Company has priced its underwritten public offering and concurrent registered direct offering of its ordinary shares at a price to the public of $3.25 per share.

Gross proceeds from both offerings are expected to be approximately $20 million.

6. Opko Health Inc. (OPK)

Lost 12.36% to close Thursday's trading at $4.61.

News: No news

Recent event:

-- On November 8, 2017, the Company reported a wider loss on lower revenue for the third quarter of 2017.

Net loss for the recent third quarter widened to $46.04 million or $0.08 per share from $15.0 million or $0.03 per share in the year-ago quarter. Similarly revenues declined to $263.5 million in the third quarter of 2017 from $298 million in the comparable year-ago quarter.

Near-term catalysts:

-- Initiate a phase 2b dose ranging study of OPK88004 to treat men with benign prostatic hypertrophy in Q4 2017. -- Initiate a phase 2b dose escalation study OPK88003 for type 2 diabetes and obesity in early 2018. -- Plans are now being finalized to begin a single dose Phase 2a trial of OPK88002 to treat pruritus (itching) in Stage 5 CKD patients undergoing dialysis.

7. XOMA Corp. (XOMA)

Lost 11.48% to close Tuesday's trading at $27.00.

News: No news

Recent event:

-- On November 6, 2017, the Company reported better-than-expected third quarter 2017 financial results.

8. Dova Pharmaceuticals Inc. (DOVA)

Lost 9.43% to close Tuesday's trading at $22.57.

News: No news

Pipeline:

-- The Company's lead product candidate is Avatrombopag for the treatment for thrombocytopenia in patients with chronic liver disease (CLD). The compound was tested in two pivotal clinical trials, ADAPT 1 and ADAPT 2, in which all primary and secondary endpoints were met with high statistical significance.

Recent event:

-- On September 22, 2017, the Company announced the submission of NDA for Avatrombopag for the treatment of thrombocytopenia in patients with chronic liver disease (CLD) who are scheduled to undergo a procedure.

9. KalVista Pharmaceuticals Inc. (KALV)

Lost 9.23% to close Tuesday's trading at $11.60.

News: No news

Recent event:

-- On October 10, 2017, KalVista entered into a collaboration with Merck (MRK) for KVD001, its intravitreal diabetic macular edema (DME) program, as well as future orally delivered plasma kallikrein inhibitors for DME developed by KalVista.

KalVista received $37 million non-refundable upfront fee from Merck, and is further eligible to receive payments that potentially total up to $715 million. KalVista also will receive tiered royalties on net sales for therapeutic candidates commercialized under this agreement.

Near-term catalyst:

-- Initiate Phase 2 proof-of-concept trial of intravitreal KVD001 for Diabetic Macular Edema later this year.

10. Vital Therapies Inc. (VTL)

Lost 8.62% to close Tuesday's trading at $5.30.

News: No news

Near-term catalyst:

-- Top-line data from phase III trial of ELAD System in subjects with severe alcoholic hepatitis are expected in the third quarter of next year.

As of October 24th, the trial was 79% enrolled based on its target of at least 150 subjects. If it is decided more than 150 subjects are needed to reach 55 deaths under the event-driven design of the trial, the top line data could be delayed.