TICKERS: ABEO, ATNM, ARQL, BSTC, BPMC, CBIO, EDGE, EPZM, KPTI, LOXO, OMED, PIRS, SRNE, STML, SNDX, SGYP, SYRS, , WVE

2017 Small-Cap Biotech Watchlist Update: Up 21% at the End of Q2/17

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If an investor had purchased an equal dollar amount of each company on The Life Sciences Report's 2017 Small-Cap Biotech Watchlist at the beginning of the year, that portfolio would show a gain of about 21% as of July. This is primarily due to the performance of a handful of companies that have been moving their assets farther down the development pipeline, according to the analysts who follow them.

Overall, as of July 12, ten Watchlist companies show gains for the first half, and the other ten show losses. Biotechs on the Watchlist for 2017 were selected by three analysts at the Biotech Showcase in January.

Leading the pack is Pieris Pharmaceuticals Inc. (PIRS:NASDAQ), which was selected by Watchlist panelist and JMP Securities analyst Michael King. The company is up ~306% in the first half of 2017.

"Since filing an IND [investigational new drug application] for PRS-343 for patients with HER-2 positive solid tumors, the company has been engaged with the FDA to finalize the clinical trial protocol for the first-in-patient study," King noted in a July 6 research report. "Pieris will begin dosing the first patient following FDA approval of the IND."

King also noted other upcoming catalysts for the company, including the filing of "a separate clinical trial application with the German and Czech regulatory authorities to conduct a multi-dose, randomized, placebo controlled trial for PRS-080 in FID patients," and sponsoring trials for PRS-060 beginning in Q4/17 in Australia.

These developments, King stated, "mark the continued advancement of these three lead programs, with read-outs anticipated in 2018." Commented on the company's anticalin platform, King added, "Anticalins have demonstrated clinical effects in patients, and the company's current candidates continue to support potential advancement. We believe the asthma and immuno-oncology markets provide significant value to the Pieris pipeline and that management has the ability to deliver on this promising technology."

Pieris stock is currently trading at ~$6 per share.

Loxo Oncology Inc. (LOXO:NASDAQ) had posted an overall gain of ~142% over the first half of the year. In a June 5 research report, JMP Securities' King, who placed the company on the Watchlist, wrote, "Loxo Oncology announced striking data across all three ongoing clinical trials of larotrectinib (LOXO-101) in patients with tumors harboring tropomyosin receptor kinase (TRK) fusions at ASCO (the annual American Society of Clinical Oncology meeting)."

In his comments, King stated, "Given the impressive activity of larotrectinib and in a highly specific target patient population, as well as its Breakthrough Therapy Designation (BTD), we anticipate its rapid approval by the FDA with commercial launch taking place shortly thereafter in 2018."

JMP raised its target price for Loxo from $53 per share to $71. The stock currently trades at ~$76 per share.

"We believe investing in LOXO represents an investment in a modern model of the oncology drug development company," King concluded.

Abeona Therapeutics Inc. (ABEO:NASDAQ) was selected for the Biotech Watchlist by two of the analysts, Raghuram (Ram) Selvaraju of Rodman&Renshaw, and George Zavoico of JonesTrading Institutional Services. Abeona stock has logged an ~80% increase since the first of the year.

Commented on the company's Q1/17 results in a May 17 research report, Selvaraju noted that Abeona's "cash position remains strong." The analyst also made note of a number of catalysts, some that have been achieved, and some that can be anticipated.

"Abeona's most advanced candidate, has been accorded Fast Track designation from the FDA as well as Orphan Drug designation in both the U.S. and Europe," Selvaraju stated. "This program in Sanfilippo Syndrome A (MPS IIIA) would be eligible for a Priority Review Voucher (PRV) as well. Abeona has secured Orphan Drug designation in the European Union for its second pipeline candidate, ABO-101, for MPS IIIB and for ABO-201 in Juvenile Batten Disease. ABO-201 could enter the clinic early next year." In addition, the company's "epidermolysis bullosa program remains on track with incremental positive data presented."

Abeona stock is currently trading at ~$9 per share.

Blueprint Medicines Corp. (BPMC:NASDAQ) ranks just above Abeona in terms of percent increase over the first half, logging in at ~85%.

Selected for the Watchlist by King, in a June 5 research report the analyst commented on the company's recent announcement of "positive updated data from its ongoing Phase I clinical trial of BLU-285 in advanced gastrointestinal stromal tumor (GIST) and plans to pursue expedited development in patients with a PDGFRα D842V mutation." King also noted that Bluesprint has announced FDA approval of breakthrough therapy designation for BLU-285, and "plans to pursue expedited development of BLU-285 in this patient population."

Reflecting on the company's "products, platform [and] personnel," King wrote, "Blueprint Medicines brings all of the elements together for a highly successful and sustainable discovery-based biotechnology company that will benefit patients with its compounds and investors with returns on its shares. We remain confident that BPMC shares will accrete as we are presented with compelling data from the company's trials of BLU-258 and BLU-554. In anticipation of the success with BPMC's two lead programs, we believe investors will also attribute a higher likelihood of success to the company's pipeline prospects."

The other top-five gainer on the Watchlist is another King pick: Syndax Pharmaceuticals Inc. (SNDX:NASDAQ). The company has posted a six-month gain of ~81%.

In a June 5 research report, JMP's King, who placed this company on the Watchlist, commented on progress on its Phase 1b/2 ENCORE 601 trial "investigating the combination of entinostat, the company's lead asset and selective HDAC inhibitor, plus Keytruda (pembrolizumab [MRK, NC]), an anti-PD-1 antibody, in patients with melanoma, NSCLC (non-small cell lung cancer), and microsatellite stable colorectal cancer."

JMP believes "Syndax represents a rare investment opportunity in the small cap oncology space." King also noted that "entinostat [has] already demonstrated a meaningful benefit in both progression-free and overall survival in a large tumor category (metastatic breast cancer). In addition to its demonstrated clinical benefit, entinostat has also received breakthrough therapy designation (BTD) from the FDA. . .With such a robust asset under development, we believe Syndax could potentially clear regulatory hurdles to rapidly translate its preclinical and clinical success with entinostat into a marketed therapy."

Other companies on the 2017 Small-Cap Biotech Watchlist include:

Actinium Pharmaceuticals Inc. (ATNM:NYSE.MKT): The stock is up ~13% since the first of the year.

ArQule Inc. (ARQL:NASDAQ): The stock is up ~6% since Jan. 1.

Asterias Biotherapeutics Inc. (AST:NYSE.MKT): The stock is down ~24% since Jan. 1.

BioSpecifics Technologies Corp. (BSTC:NASDAQ): The stock is down ~11% since the first of the year.

Catalyst Biosciences Inc. (CBIO:NASDAQ): The stock is down ~97% since Jan 1.

Edge Therapeutics Inc. (EDGE:NASDAQ): The stock is down ~18% since the first of the year.

Epizyme Inc. (EPZM:NASDAQ): The stock is up about ~18% over the first half.

Karyopharm Therapeutics Inc. (KPTI:NASDAQ): The stock is down ~1% since the start of the year.

OncoMed Pharmaceuticals Inc. (OMED:NASDAQ): The stock has declined ~56% since the start of the year.

Sorrento Therapeutics Inc. (SRNE:NASDAQ): The stock has declined ~61% in the first half.

Stemline Therapeutics Inc. (STML:NASDAQ): The stock is down ~18% since the first of the year.

Synergy Pharmaceuticals Inc. (SGYP:NASDAQ): The stock is down ~28% since Jan. 1.

Syros Pharmaceuticals (SYRS:NASDAQ): The stock is up ~40% since the first of the year.

Threshold Pharmaceuticals Inc. (THLD:NASDAQ): The stock is up ~1% since the first of the year.

WAVE Life Sciences Ltd. (WVE:NASDAQ): The stock down ~36% since Jan. 1.

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1) Tracy Salcedo compiled this article for Streetwise Reports LLC and provides services to Streetwise Reports as an independent contractor. She or members of her household own securities of the following companies mentioned in this article: None. She or members of her household are paid by the following companies mentioned in this article: None.
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