Arch Therapeutics Inc. (OTCMKTS:ARTH)

Update on Northwest Biotherapeutics, Inc (OTCMKTS:NWBO)

Northwest Biotherapeutics, Inc (OTCMKTS:NWBO)

Northwest Biotherapeutics, Inc (OTCMKTS:NWBO), headquartered in Bethesda, MD, is a clinical stage biotechnology company that develops personalized cancer vaccines to treat a wide range of solid tumor cancers. The company has a market capitalization of over $35 million and trades less than 1.5 million shares daily based on their 30-day average. Today NWBO share volumes are trading at four times their averages.

At the center of their strategic advantage is the DCVax technology platform. DCVax uses activated dendritic cells (the master cells of the immune system) to educate the body’s entire immune system on how to attack a cancer. Conventional cancer treatments use one active agent to hit one target on the cancer while DCVax uses many active agents to hit many targets on the cancer. Northwest Biotherapeutics, Inc (OTCMKTS:NWBO) believes there are three aspects of the DCVax system that have indicated promise for the technology. First, the DCVax system mobilizes the entire immune system, not just a single immune agent. Secondly, DCVax targets all of the biomarkers on a cancer patient’s tumor, not just one. Lastly, DCVax uses the patient’s own tumor to develop the specific treatment. This highly customized approach has, to date, produced positive results. DCVax has achieved clinical benefits. Over 80% of the patients who were treated with the DCVax system approach experienced a longer delay in the cancer’s progression and an extension of survival when compared to patients who received a more traditional standard of care.

Three drug candidates are in the Northwest Biotherapeutics, Inc (OTCMKTS:NWBO) pipeline. DCVax-L is in Phase 3 trails for the indication of brain cancer and in Phase 2 trials for the indication of metastatic overian cancer. DCVax-Direct has a Phase 1/2 trial underway currently. DCVax-Prostate has been cleared by the FDA for Phase 3 trials and Northwest Biotherapeutics, Inc (OTCMKTS:NWBO) is currently searching for an appropriate partner to begin the trial.

Over a month ago, Northwest Biotherapeutics, Inc (OTCMKTS:NWBO) closed on a $7.5 million fund raise with several institutional investors. The common shares were priced at $0.26 per share while the class C warrants were priced at an exercise price of$0.25 with $0.01 to be paid per share when exercised. This was done in order to ensure all of the investor’s equity stayed below 5%.

I have no positions in any stocks mentioned, and no plans to initiate any positions within the next 96 hours. All information, or data, is provided with no guarantees of accuracy.

About the author: Steve Clark is a 23-year Wall St professional with stints in M&A, risk management, and algorithm trading.

Company overview: Bionik Laboratories Corp (OTCMKTS:BNKL)

Bionik Laboratories Corp (OTCMKTS:BNKL)  is in the medical devices and robotics business. Its products are used to provide rehabilitation and mobility support to people afflicted by neurological disorders.

On February 15, the company provided an update of its financials and operations, primarily releasing a summary of its financial performance in the most recent quarter compared to a year ago and hitting about how it intends to drive future growth.

Financials update

Bionik booked an EPS loss of $0.01 in the December quarter, which is its fiscal 3Q2016. That was an improvement from EPS loss of $0.02 in the year ago quarter. Revenue for the latest quarter was $0.4 million, up significantly from the prior year when it generated no revenue.

Interactive Motion Technologies Inc. (IMT), an asset that Bionik acquired in 2016, was a major revenue contributor in the latest quarter. The business generated revenue of nearly $1 million in the December 2015 quarter, but that was before Bionik completed its acquisition.

Even after Bionik completed the acquisition of IMT, its contribution to the topline in 2016 was significantly limited because it didn’t have a commercial team due funding shortage. Bionik has now hired a sales and marketing team for IMT and it expects sales from the business to begin accelerating. The company is banking on strong clinical profile and a motivated sales team to drive significant sales of IMT products.

Bionik’s operations consumed slightly more than $1.6 million in the latest quarter, up from $1.1 million in the year-ago quarter. The major cost drivers in the latest quarter were sales and marketing expenses that increased $0.38 million from the prior year. Research and development costs were $0.57 million, down slightly from $0.59 million a year earlier. General and administration costs of $0.41 million in the latest quarter decreased from $0.44 million in the prior year.

Bionik concluded the December 2016 quarter with cash and equivalents of slightly more than $0.58 million. It had a working capital deficit of more than $3.4 million at the end of that quarter. However, the management said the working capital would be more than $0.85 million if certain items such as warrant derivative liabilities are factored out.

Operations financing

Bionik said it is evaluating financing options to ensure that it can continue with its operations. The financing options being explored include strategic partnerships. As part of its financial restructuring, Bionik announced on February 27 that it had entered into an agreement with an entity called Park Hill Capital Inc. to extend the maturity of certain promissory notes. The maturity of those notes has been extended to July 1, 2017, allowing Bionik a bit of financial flexibility especially as it struggles with working capital deficit.

Operating updates

Bionik said its products have been tested in more than 240 locations in 20 countries with the tests generating clinical data that further strengthen the foundation for their commercialization success. It further said that it has come up with a development and commercialization strategy that will guide the building of leading robotic products targeting hospital and homes.

The management of Bionik also said it is focused on expanding the company’s global footprint as part of the efforts to drive future growth. The company is also focused on expanding its line of products to unlock more revenue growth and shareholder value.

Addressable robotics market

The market for healthcare robots is expanding steadily. Research firm Tractica estimates the market for medical robots will grow at a compound annual growth rate (CAGR) of 9.7% between 2016 and 2021. As such, the size of the market is expected to be $2.8 billion by 2021 compared to $1.7 billion in 2016.

Bionik is eyeing the $2.8 billion market by 2021 as it works to develop new robotic products and expand into more global locations. Bionik’s ambitions clash with those of Transenterix Inc (NYSEMKT:TRXC), Accuray Incorporated (NASDAQ:ARAY), Corindus Vascular Robotics Inc (NYSEMKT:CVRS) and Immersion Corporation (NASDAQ:IMMR) because these companies are also training their eyes on the market.

While surgical robots currently represents the largest share of healthcare robotics,  Tractica survey shows that is likely to change in the coming years with exoskeletons and prosthetics robots taking the lead.

Talent hiring

On February 27, Bionik announced that it hired Malcolm G. Bock to be its VP of engineering. It said that Bock is a veteran of medical devices industry and that his contribute would help advance the company’s growth strategy.

Bock joined Bionik from an entity called Respiratory Motion, where he served as VP of Engineering and oversaw the development of new products and technologies. He was also senior director of global R&D and Covidien where he oversaw the launch of at least 15 new products over a period of 10 years. His contribution earned him the Covidien Inventor of the Year award.

Uplisting on the NASDAQ

Bionik is planning to uplist on the NASDAQ. That led to the company to change its financial year-end from December to March as part of the preparation for NASDAQ listing.