Viking Therapeutics, Inc. (NASDAQ: VKTX) is a clinical-stage biopharmaceutical company focused on the development of novel, therapies for metabolic and endocrine disorders. Viking has exclusive worldwide rights to a portfolio of five therapeutic programs in clinical trials or preclinical studies, which are based on small molecules licensed from Ligand Pharmaceuticals Incorporated.
October 24, 2017.Viking announced positive final results from an eight-week study of VK2809 in an in vivo model of non-alcoholic steatohepatitis (NASH). Data from this study demonstrated statistically significant improvements in several key measures relevant to the development and progression of NASH. Additionally, an evaluation of gene expression changes demonstrated statistically significant changes in the expression of multiple genes associated with the development and progression of NASH following eight weeks of treatment with VK2809, as compared to vehicle control.
October 23, 2017. The company announced positive results from a 25-week proof-of-concept study of VK0214 in an in vivo model of X-linked adrenoleukodystrophy (X-ALD). The final study data were presented in a poster presentation at the 87th Annual Meeting of the American Thyroid Association (ATA), held October 18-22, 2017, in Victoria, British Columbia.
The results of this study showed that treatment with VK0214 led to statistically significant reductions in plasma levels of multiple very long chain fatty acids (VLCFAs), including the benchmark highly toxic C26 fatty acid, in treated animals compared with vehicle controls.
October 9, 2017. Viking Therapeutics, Inc. hosted a key opinion leader (KOL) event that featured presentations on VK5211 as well as the hip fracture market, the lack of effective osteoporosis treatments, and regulatory outcomes for therapies targeting sarcopenia and hip fracture.
VK5211 is a third-generation non-steroidal Selective Androgen Receptor Modulator (SARM) that is being developed for maintenance or improvement of lean body mass (LBM), bone mineral density (BMD), and function in patients recovering from non-elective hip fracture surgery.
The VKTX lead clinical program, VK5211, is a novel, orally available, non-steroidal selective androgen receptor modulator, or SARM, in development for the treatment of patients recovering from non-elective hip fracture surgery. VK5211 is designed to produce the therapeutic benefits of testosterone in muscle and bone with improved safety, tolerability and patient acceptance. They have initiated a Phase 2 clinical trial with VK5211 in patients recovering from non-elective hip fracture surgery.
The second pipeline program is focused on the development of novel small molecule agonists of the thyroid beta (TRb) receptor, VK2809 and VK0214. These novel TRb agonists are being developed for hypercholesterolemia and fatty liver disease and X-linked adrenoleukodystrophy, or X-ALD. The company has initiated Phase 2 clinical development of VK 2809 in hypercholesterolemia and fatty liver disease. VK0214 is in preclinical development for X-ALD.
They are also developing VK0612, a first-in-class, orally available drug
Viking Therapeutics, Inc. is a clinical-stage biopharmaceutical company focused on the development of novel, first-in-class or best-in-class therapies for metabolic and endocrine disorders. The company’s research and development activities leverage its expertise in metabolism to develop innovative therapeutics designed to improve patients’ lives. Viking has exclusive worldwide rights to a portfolio of five therapeutic programs in clinical trials or preclinical studies, which are based on small molecules licensed from Ligand Pharmaceuticals Incorporated. The company’s clinical programs include VK5211, an orally available, non-steroidal selective androgen receptor modulator, or SARM, in Phase 2 development for the treatment and prevention of lean body mass loss in patients who have undergone hip fracture surgery, VK2809, a small molecule thyroid beta agonist in Phase 2 development for hypercholesterolemia and non-alcoholic fatty liver disease, and VK0612, a first-in-class, orally available drug candidate in Phase 2 development for type 2 diabetes. Viking is also developing novel and selective agonists of the thyroid beta receptor for GSD Ia and X-linked adrenoleukodystrophy, as well as two earlier-stage programs targeting metabolic diseases and anemia.
Jul-17-17 Reiterated H.C. Wainwright Buy $5 → $7
Research and development expenses for the three months ended June 30, 2017 were $3.7 million compared to $2.4 million for the same period in 2016. The increase was primarily due to increased activities related to our clinical trials for our VK5211 and VK2809 programs, third party manufacturing of our clinical-stage drug candidates, and preclinical efforts for our VK0214 program.
General and administrative expenses for the three months ended June 30, 2017 were $1.3 million compared to $1.2 million for the same period in 2016. This small increase was primarily due to increases in salaries and benefits and legal expenses, offset by a decrease in non-cash stock compensation expense.
For the three months ended June 30, 2017, Viking reported a net loss of $5.2 million, or $0.21 per share, compared to a net loss of $3.7 million, or $0.22 per share, in the corresponding period in 2016. The increase in net loss for the three months ended June 30, 2017 was primarily due to the increase in research and development expenses noted previously.
Research and development expenses for the six months ended June 30, 2017 were $7.2 million compared to $4.2 million for the same period in 2016. The increase in research and development expenses was primarily related to increases in expenses related to clinical trial activity for our VK5211 and VK2809 programs and preclinical efforts for our VK0214 program, as well as third party manufacturing of our clinical-stage drug candidates.
General and administrative expenses for the six months ended June 30, 2017 were $2.7 million compared to $2.6 million for the same period in 2016. This small increase was primarily due to increases in salaries and benefits, offset by a decrease in non-cash stock compensation expense.
For the six months ended June 30, 2017, Viking reported a net loss of $10.4 million, or $0.45 per share, compared to a net loss of $7.3 million, or $0.56 per share, in the comparable period in 2016. The increase in net loss for the six months ended June 30, 2017 was primarily due to the increase in research and development expenses noted previously.
At June 30, 2017, Viking held cash, cash equivalents and investments totaling $12.1 million. As of July 31, 2017, Viking had 27,697,284 shares of common stock outstanding.
Viking is expected to release its Q3 earnings on or about November 9, 2017.
Stock Influences and Risk Factors
If one or more of their current drug candidates receives regulatory approval or gets commercialized, it would be a significant catalyst;
VKTX is a clinical-stage company, and expects to incur significant operating losses during the next stages of corporate development.
The company is dependent on technologies licensed from Ligand, and if they lose the license, their ability to develop existing and new drug candidates would be harmed.
The biotech space is a high-risk sector due to uncertainties associated with the novel drug development. Any adversities related with the same could upset the stock performance significantly.
On Monday, October 30, 2017, in intra-day trading, VKTX shares were at $2.33 on traded volume of 140K shares. The current RSI (14) is 53.70.
At $2.33 VKTX shares are trading above their 50-day moving average of $1.70 and their 200-day moving average of $1.38/ share.
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