Oxis International, Inc. (OTCQB: OXIS), through its wholly owned subsidiary, Oxis Biotech, Inc., develops innovative drugs focused on treatment of cancer and other unmet medical needs. Oxis’ lead drug candidate, OXS-1550 (DT2219ARL) is a novel bispecific scFv recombinant fusion protein-drug conjugate composed of variable regions of the heavy and light chains of anti-CD19 and anti-CD22 antibodies and a modified form of diphtheria toxin as its cytotoxic drug payload.
The company recently announced that the Food and Drug Administration has given clearance to its wholly owned subsidiary, Oxis Biotech Inc., to begin a Phase 2 clinical trial for its promising cancer treatment OXS-1550 for the treatment of lymphoma and leukemia. The Phase II clinical trial of OXS-1550 will be conducted with its partner, the University of Minnesota’s Masonic Cancer Center.
This achievement represents a major milestone for the company. The product candidate has performed well in its phase 1 studies in blood cancers and the management is bullish about the potential for positive results in Phase 2.
As per management, this next generation drug has the possibility of treating several different liquid tumors and, if successful, will drastically change the paradigm now being developed that relies on highly expensive autologous cell therapies.
If OXS-1550 is proven in the Phase II clinical trial, there’s a potential market for the company to exploit, once it launches this selective cancer agent to market i.e. one that only targets cancerous cells, or at least effects a small number of healthy cells. The present traditional treatment is unable to differentiate between healthy cells and cancerous ones. Clinical data for the phase-2 is not likely to be announced before June 2018, however, there is ample scope for in-between interim updates from the company, which could be a near term triggers for the stock.
The company recently entered into a sponsored research agreement with the University of Minnesota to conduct a toxicity study of its TriKE cancer treatment (OXS-3550), a required step before it can apply for a Phase 1 clinical trial with the Food and Drug Administration. There are possibilities of a positive FDA announcement from this drug development as well.
Description & about the Company:
OXIS International, Inc., through its wholly owned subsidiary Oxis Biotech, Inc, is an immuno-oncology company with a robust technology platform consisting of bispecific and trispecific scFv constructs, full-length antibodies, proprietary drug payloads, proprietary antibody-drug linkers, dual-drug payload antibody-drug conjugates (ADCs), bispecific targeted ADCs, and NK cell and T-cell antibody directed cell-mediated cytotoxic (ADDCs) agents.
OXIS does not currently own or operate manufacturing facilities to produce clinical or commercial quantities of any of its product candidates. It relies on a small number of third-party manufacturers to produce compounds, and expects to continue to do so to meet the preclinical and clinical requirements of their potential product candidates as well as for all their commercial needs.
The company’s lead drug candidate, OXS-1550 is a novel bispecific scFv recombinant fusion protein-drug conjugate, which is composed of the variable regions of the heavy and light chains of anti-CD19 and anti-CD22 antibodies and a modified form of diphtheria toxin as its cytotoxic drug payload.
Product Pipeline & stages:
Oxis International, Inc. is engaged in the development of immunotherapies for the treatment of cancer
- Source: Company’s website
- The company has recently received clearance to begin Phase 2 clinical trial for its cancer treatment OXS-1550
Risk Factors & Key Stock Influences:
Competitive landscape: The players in the biotechnology and pharmaceutical industries face competition from domestic and foreign biotechnology companies, large pharmaceutical companies, and other institutions. Several companies are pursuing the development of pharmaceuticals in similar targeted areas. According to the Pharmaceutical Manufacturers Research Association, at the end of 2015 there were 168 drugs in development for the treatment of breast cancer, and there were 135 drugs in development for the treatment of lymphomas (blood cell cancers including multiple myeloma). Therefore, the company’s business risk profile is subject to intense competition in the industry.
Clinical data for the OXS-1550 Phase-2 is not likely to be announced before June 2018, however, there is opportunity for interim updates from the company, which could be a near term triggers for the stock.
The company has constrained liquidity & financial flexibility. It is expected to continue to incur operating losses for the near future and these losses could potentially increase as Oxis continues its development initiatives. Therefore, any inability to obtain additional financing in a timely manner, could constrain the business prospects of the company.
Any additional funding raises the risk of stock dilution. Given its present liquidity situation, Oxis is going to need to raise funds for ongoing programs.
As of December 31st, 2016, the Company has generated no revenue per its financial statements. During the year ended December 31, 2016 and 2015, it incurred $975,000 and $1,000,000 of research and development expenses.
Liquidity and Capital Resources:
As of December 31, 2019, Oxis had cash and cash equivalents of $19,000. This cash and cash equivalents are in part the result of the proceeds from borrowings in 2016. The company had total current assets of $21,000, and overall working capital deficit of $18,928,000.
Based upon this cash position, may be necessary for the company to raise additional capital by the end of the next quarter to continue to fund current operations. The Company is pursuing several alternatives to address this situation, including raising additional funding through equity or debt financings. To finance existing operations and pay current liabilities over the next twelve months, Oxis would need to raise approximately $4-5 million of capital.
On Thursday, April 6, 2017, in intraday trading, OXIS shares declined by -14.63% to $0.0175 on volume of 6.52 Million shares exchanging hands. Market capitalization is $1.31 million.
In the past 52 weeks, shares of Oxis have traded as low as $0.01 and as high as $0.65.
At $.0175, shares of Oxis are trading below their 50-day moving average (MA) at $0.04 and their 200-day MA at $0.15. The current RSI is 42.96.
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