Did You Invest In These Biotech Stocks?

(RTTNews) - It's been a year since we started the column "This Day That Year" featuring some of the biotechs that have completed a year of listing. Here's a look back at the journey of those stocks so far and look ahead at some of what's in store for them.

1. The first stock featured under this column was BeyondSpring Inc. (BYSI) on March 9, 2018.

BeyondSpring is a clinical-stage biopharmaceutical company developing innovative immuno-oncology cancer therapies.

The Company's lead drug candidate is Plinabulin, a marine-derived small-molecule, in late-stage clinical development as an anticancer therapy in non-small cell lung cancer (NSCLC) and for the prevention of chemotherapy-induced neutropenia (CIN).

BYSI was trading around $26 when we published the report, and it went on to touch a high of $33.30 on April 26, 2018, which reflects a gain of 26%. Now, the stock has given back all its gains and trades around $17.

Near-term Catalysts:

-- Submission of a new drug application to the China Food and Drug Administration or National Medical Products Administration for the use of Plinabulin for the treatment of chemotherapy-induced neutropenia in early 2019. -- Submission of a new drug application to the U.S. Food and Drug Administration for the use of Plinabulin for the treatment of chemotherapy-induced neutropenia in the second half of 2019. -- Submission of a new drug application to the China Food and Drug Administration or National Medical Products Administration for the use of Plinabulin for the treatment of non-small cell lung cancer in the first half of 2019. -- Submission of a new drug application to the U.S. Food and Drug Administration for the use of Plinabulin for the treatment of non-small cell lung cancer in 2020.

2. Tocagen Inc. (TOCA)

We profiled Tocagen on April 13, 2018, when it was trading around $11. The stock price kept trending down between then and August 31, 2018, even touching a low of $8.10 on August 27, 2018, after which it reversed course and went on to touch a high of $15.80 on September 28, 2018. That implies a 43% gain from our published price. Now, the stock has given back all its gains and trades around $10.

Tocagen is a cancer-selective gene therapy company developing therapies that are designed to destroy tumors, leaving the healthy tissues unharmed.

The Company's lead drug candidate is a combination of Toca 511, an investigational injectable retroviral replicating vector (RRV) that encodes a prodrug activator enzyme, cytosine deaminase, and Toca FC, an investigational, orally administered, extended-release formulation of 5-fluorocytosine (5-FC). Toca 511 and Toca FC are to be used together.

A phase III trial of Toca 511 & Toca FC in patients with recurrent high-grade glioma, or HGG, the most common and aggressive primary brain cancer, dubbed Toca 5, is underway.

Near-term Catalysts:

-- Toca 5 second interim analysis expected in the second quarter of 2019. -- Toca 5 final analysis planned for the fourth quarter of 2019.

3. Biohaven Pharmaceutical Holding Co.Ltd. (BHVN)

Biohaven was trading around $27 when we profiled it on May 4, 2018. Since then, the stock has been trending higher, and it touched an all-time high of $49.10 on March 5, 2019. That equates to a gain of 77% based on our published price.

Biohaven is a clinical-stage biopharmaceutical company developing drugs for neurological diseases, including rare disorders.

The Company's lead drug candidate is Rimegepant (BHV-3000) for the acute treatment of Migraine. Also in the pipeline are BHV-3500 for the acute treatment and prevention of migraine; Trigriluzole for patients with Obsessive-Compulsive Disorder, BHV-0223 for patients with Amyotrophic Lateral Sclerosis, and BHV-5000, which is being developed as a potential treatment for neuropsychiatric disorders such as Rett syndrome.

Near-term Catalysts:

-- Submit New Drug Applications for Rimegepant Zydis ODT and tablet formulations for the acute treatment of migraine in 2Q, 2019. -- Completion of enrollment in phase III Rimegepant preventive treatment of migraine trial in 2Q, 2019. -- Initiation of phase II/III trial of BHV-3500, intranasal administration for acute treatment of migraine in 1Q, 2019.

4. G1 Therapeutics Inc. (GTHX)

We profiled G1 Therapeutics on May 17, 2018, when it was trading around $49. The stock rallied in the successive months and went on to touch a high of $69.57 on September 11, 2018. That implies a gain of 41% from our published price. The stock has given back all its gains and currently trades around $17.

The Company's lead drug candidate is Trilaciclib, under phase II trials in small cell lung cancer and metastatic triple-negative breast cancer. Preliminary results from the trials were reported last year, and they showed meaningful benefit for the drug candidate across different indications, lines of therapy and chemotherapy regimens.

Also in the pipeline are Lerociclib, under two phase I/II trials in breast cancer and in non-small cell lung cancer, and G1T48, under a phase I/IIa clinical trial as monotherapy for the treatment of ER+, HER2-breast cancer.

Near-term Catalysts:

-- Meet with the U.S. and European regulatory authorities in the first half of 2019 and announce the next steps for Trilaciclib development in the second quarter of 2019. -- Initiate additional randomized trials for Trilaciclib in the second half of 2019, pending feedback from regulatory authorities. -- Report additional data from all four randomized phase II Trilaciclib clinical trials. -- Present additional data from phase Ib clinical trial of Lerociclib/Faslodex in ER+, HER2- breast cancer in the second half of 2019. -- Present preliminary dose-escalation data from phase Ib clinical trial of Lerociclib/Tagrisso in non-small cell lung cancer in the second half of 2019. -- Present preliminary dose-escalation data from phase I clinical trial of G1T48, an oral selective estrogen receptor degrader (SERD), in ER+ breast cancer in the second half of 2019.

5. Athenex Inc. (ATNX)

Athenex was trading around $17 when we profiled it on June 14, 2018. The stock rallied in the successive weeks, and it touched a high of $20.90 on July 26, 2018, equating to a gain of only 19% from our published price. Now, the stock has given back all its gains and trades around $11.

Athenex is a global biopharmaceutical company focused on developing novel therapies for the treatment of cancer. The Company has an Oncology pipeline, a Commercial Platform, and a Global Supply Chain Platform.

Near-term Catalyst:

The Company is slated to release its fourth quarter and fiscal year ended December 31, 2018 earnings results on March 11, 2019, before the market opens.

6. Clementia Pharmaceuticals Inc. (CMTA)

Clementia was featured in our column on August 2, 2018, when it was trading around $10. After being in a downtrend till October 23, 2018, the stock reversed course and kept heading higher.

CMTA touched a high of $26.36 on February 25, 2019, following the acquisition of the Company by Ipsen for a total transaction value of up to US$1.31 billion.

7. Zealand Pharma A/S (ZEAL)

Zealand Pharma was trading around $14 when we profiled it on August 9, 2018. The stock rallied in the successive weeks, and it touched a high of $18.91 on September 18, 2018, reflecting a gain of 32% from our published price. Now, the stock has given back all its gains and trades around $14.

Zealand is a biotechnology company focused on developing peptide-based medicines for gastrointestinal, metabolic and other specialty diseases.

The Company has two marketed products and a couple of clinical programs.

Near-term Events & Catalysts:

-- The first patient in a phase III trial with Dasiglucagon for the treatment of congenital hyperinsulinism was dosed on March 6, 2019. -- A second phase III trial with Dasiglucagon for the treatment of congenital hyperinsulinism is anticipated to begin in 2019. -- The remaining clinical trials of Dasiglucagon HypoPal rescue pen for severe hypoglycemia are underway, with results expected in mid-2019 results. -- A phase III trial of Glepaglutide for short bowel syndrome is underway, with results expected in 2020.

8. Rhythm Pharmaceuticals Inc. (RYTM)

We profiled Rhythm Pharmaceuticals on October 5, 2018, when it was trading around $27. The stock rallied in the successive weeks and it touched a high of $32 on November 9, 2018, implying a gain of 19% from our published price.

Rhythm Pharma is a biopharmaceutical company developing therapies for the treatment of rare genetic disorders of obesity.

The Company's lead drug candidate is Setmelanotide, under two phase III clinical trials in pro-opiomelanocortin (POMC) and leptin receptor (LEPR) deficiency obesity, two ultra-rare genetic disorders.

In parallel, Setmelanotide is also under a combined pivotal phase III trial in Bardet-Biedl syndrome and Alström syndrome.

Near-term Catalysts:

-- Initial data from the two phase III trials of Setmelanotide in both POMC and LEPR deficiency obesity are expected in the third quarter of 2019. -- Enrollment in the combined phase III trial evaluating Setmelanotide in BBS and Alström syndrome is expected to be completed in the second half of 2019, with topline data anticipated in 2020.

9. OrthoPediatrics Corp. (KIDS)

We profiled OrthoPediatrics on October 12, 2018, when it was trading around $32. The stock touched a high of $43.65 on March 1, 2019, implying a gain of 34% from our published price.

OrthoPediatrics is a revenue-generating medical device company focused exclusively on pediatric orthopedics.

Recent event:

-- On March 6, 2019, the Company reported its financial results for the fourth quarter and full year ended December 31, 2018.

2018 marked the tenth consecutive year of over 20% annual revenue growth for the Company.

For the full year 2019, the Company has forecast revenue growth in a range of 21.0% to 23.0%. The total revenue for 2018 was $57.6 million, a 26.2% increase compared to $45.6 million for 2017.