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EOLS Recovers, BLCM Awaits DATA, Time To Keep An Eye On RARX

pharma daily 052518 lt

The following are some of today's top gainers in the pharma/biotech sector.

1. Evolus Inc. (EOLS)

Gained 13.61% to close Monday's (June 11) trading at $29.05.

News: No news

The stock touched an all-time high of $39.50 on June 7, 2018, only to close at $25.57 the following day, down 35%. It recovered some of its losses today.

News: No news

Recent events:

-- On May 16, 2018, the FDA rejected the Company's Biologics License Application for DWP-450 for the treatment of glabellar lines, also known as frown lines, in adult patients, a rival to Allergan (AGN) Botox.

There were deficiencies in items related to Chemistry, Manufacturing, and Controls ("CMC") processes that led to the rejection. However, no deficiencies were related to clinical or non-clinical matters. Evolus expects to respond with a complete submission to FDA within 90 days.

-- The same day, i.e., on May 16, 2018, the Company also announced good news related to favorable completion of FDA's pre-approval inspection of Daewoong's manufacturing facility in South Korea which was purpose built for production of DWP-450.

2. Arcturus Therapeutics Ltd. (ARCT)

Gained 12.60% to close Monday's trading at $8.49.

News: No news

Recent events:

-- On February 2, 2018, Joseph Payne was terminated as President and Chief Executive Officer. Payne owns about 13.7% of the issued and outstanding shares in the Company. He had sought Court's intervention to prohibit the attempt of the Arcturus board of directors to undertake a highly dilutive equity financing.

Certain directors were attempting to sell 24.9% of Arcturus' share capital to a single purchaser at a purchase price that was more than 40% below the trading price of Arcturus common shares prior to the termination of Payne.

The Court also found that the board's decision to sell shares was not being undertaken to raise necessary working capital, and that the members of the Arcturus board are motivated by their own self-interests instead of the interests of Arcturus and its shareholders.

-- On May 29, 2018, the Company reached a settlement agreement with Joseph Payne.

-- On May 31, 2018, Peter Farrell was named as Chairman of the Board of Directors of the Company. Joseph Payne was reinstated as President and CEO and Pad Chivukula was reinstated as Chief Scientific Officer and Chief Operating Officer.

3. Bellicum Pharmaceuticals Inc. (BLCM)

Gained 12.93% to close Monday's trading at $9.52.

News: No news


The Company's lead product candidate is BPX-501 under multiple phase 1/2 clinical trials in adults and pediatric patients with leukemias, lymphomas, and genetic blood diseases in the U.S. and Europe. Also in the pipeline are BPX-601, BPX-701, and CaspaCIDe-enabled CD19 CAR-T, all under phase I studies.

Near-term Catalysts:

-- Top line data from the BPX-501 E.U. registration trial in malignant and nonmalignant pediatric patients undergoing haploidentical hematopoietic stem cell transplant is expected at the end of 2018.
-- Interim analysis of a comparator trial of malignant and nonmalignant patients receiving a matched unrelated donor (MUD) HSCT is also expected this year.
-- Initial findings from phase I clinical trials of BPX-601 in pancreatic cancer, BPX-701 in AML/MDS, and CaspaCIDe-enabled CD19 CAR-T in pediatric ALL are expected to be reported later this year.

4. CohBar Inc. (CWBR)

Gained 11.89% to close Monday's trading at $9.22.

News: No news

Clinical Trials & Near-term Catalyst:

The lead drug candidate is CB4211, for nonalcoholic steatohepatitis (NASH) and obesity. The Company plans to initiate the Phase 1a/1b clinical trial in mid-2018, with an activity readout expected in early 2019.

Recent event:

-- On December 15, 2017, CohBar's common stock was uplisted to the NASDAQ Capital Market from the OTCQX Best Marketplace.
-- On June 7, 2018, the Company announced the appointment of Philippe Calais to its Board of Directors, and to the Board's Audit Committee.

Upcoming event:

The Company will provide an update for investors via conference call and accompanying slide presentation on June 19, 2018.

5. Vascular Biogenics Ltd. (VBLT)

Gained 10% to close Monday's trading at $2.75.

News: No news

Pipeline & Catalysts:

The Company's lead product candidate is VB-111, is a targeted anti-cancer gene-based biologic agent in rGBM, ovarian cancer and thyroid cancer. Also in the pipeline are VB-600 platform of biologic agents targeting MOSPD2 for oncology and inflammatory indications.

A phase III trial of VB-111 in platinum-resistant ovarian cancer, dubbed OVAL, underway. An efficacy interim readout is expected to occur in the fourth quarter of 2019.

6. Ra Pharmaceuticals Inc. (RARX)

Gained 9.41% to close Monday's trading at $8.37.

News: No news


The Company's lead product candidate is RA101495 SC, with a potential for treating paroxysmal nocturnal hemoglobinuria (PNH), generalized myasthenia gravis (gMG), atypical hemolytic uremic syndrome (aHUS), and lupus nephritis (LN).

Near-term Catalysts:

-- Enrollment in a phase II clinical trial of RA101495 SC in gMG has been completed, with data expected in the first half of 2019.
-- A phase III clinical trial of RA101495 SC in PNH is expected to be initiated in the second half of this year.
-- A phase 1b clinical trial evaluating RA101495 SC in patients with renal impairment is ongoing. To date, eleven patients have been dosed in the study, and study results are expected mid-2018.

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