OncoSec Medical, Inc. (OTCQB:ONCS) appears to be one of the best-kept secrets in the biotech sector. As I have watched the developments over the last few months and see what could be in store in coming weeks and months, I can't help but think the upside for this $19 million company could be substantial for shareholders. However, with each spike in volume and share price as promising events unfold, the company's common shares seem to settle back to its current level of support around $0.20 per share. My view on the strange behavior of the company's stock price is fairly simple. Traders rather than shareholders have been creating liquidity and spikes in the share price with each positive PR. It is my opinion that these traders are content with quick 10-20% gains as they exit the stock and never look back. However, once true investors who are more interested in midterm and longer-term holdings begin buying the shares as they gain more of an understanding of what the company and its OMS platform is about, I anticipate a steadier uptrend to expected catalysts. It is these true long holders that will control the fate of the company's share price as they consume the float and traders have fewer shares to work with as the investors hold strong. However, until these shareholders understand where this company could be going, the stock chart could remain in the current tight range it is currently trading in.
I contacted OncoSec CEO and president, Punit Dhillon, in order to help us gain a better understanding of the company's plans and future prospects. He was gracious enough to answer a few questions to give us a better feel for where the company could be heading in the coming weeks, months, and years ahead.
[CF] Mr. Dhillon, thank you for taking time from your busy schedule to speak with me and your company's shareholders. It says a lot about a company's management when it is willing to step out of its comfort zone and address shareholders directly.
[CEO] Thank you. I appreciate the opportunity to address any concerns and provide some answers for the shareholders who put faith and trust in our joint venture of company and investors.
[CF] Could you give us a status on the ongoing statistical re-evaluation of the NeoPulse phase III data?
[CEO] We have completed analysis of the phase III H&N cancer data and presented these results at this year's International Head and Neck Cancer Conference (July 2012 - Toronto, Canada). The abstract for this data presentation can be found here and our press release regarding the data here. Currently, we are evaluating the extensive database of information obtained from both the phase III and IV NeoPulse trials pertaining to the pharmacoeconomic benefit for our therapy. These results will likely be published in Q1 2013.
[CF] Would it be wise to have a third party review the data to present a more unbiased interpretation of the results?
[CEO] Yes, it is always beneficial to have a third party review data from your clinical trials. However, with only so many resources and a strong focus on the ImmunoPulse program, it is currently not a priority for the company. Our focus for the NeoPulse program is to present the data to a number of specifically targeted potential partners for their evaluation as a license opportunity. If we can land a partner for this program, which we see as a near-term commercial opportunity, then we feel that this would be a significant validation of our data and the NeoPulse program.
[CF] Will interim data for the two most advanced phase II ImmunoPulse trials come out in Q4 or could it be Q1 2013?
[CEO] Interim analysis is currently on going for both the melanoma trial (OMS-I100) and the Merkel cell carcinoma trial (OMS-I110). These results are expected to be presented at a scientific conference before the end of 2012.
[CF] I love the obvious adaptability of your OMS electroporation platform to potentially use any of a number of cancer treatment agents. Are there any plans on trying different chemotherapy or immunotherapy agents in the short to mid term?
[CEO] Yes, the company is continuing to evaluate several different agents, both chemotherapeutic and immunotherapeutic, in combination with our OMS electroporation device.
[CF] The trial data seems impressive so far. Can you put a "real world" perspective on the treatment in terms of its effect on an individual patient or patients?
[CEO] Certainly. In a recent article in the San Francisco Chronicle, David Amoroso, a patient undergoing a clinical trial at UCSF using ImmunoPulse for metastatic melanoma, had only a 24% chance of living to see the next decade. He started the study in March 2012, and our OMS treatment "seemingly zapped all but two of the six cancerous lumps that are evident." Mr. Amoroso commented "the fact that four tumors are gone," he said, "to me, seems successful." Mr. Amoroso elaborated comically on the only real side effects of the treatment "you're getting 1,300 volts, and all of a sudden it just hits you and you're in shock for about two seconds and there's no residual pain following it. It really feels like somebody whacked you with a two-by-four on the side of your head without pain."
[CF] What would you like to convey to potential shareholders from a financial and investment standpoint?
[CEO] I believe OncoSec is extremely undervalued considering our data and efficacy results. Our phase I data are best in class for any metastatic melanoma program in history. We have met every milestone that we have set out to reach from the birth of the company, have been extremely aggressive in our timelines and have exceeded our enrollment expectations for our programs. We have exciting milestones coming up - all to be complete by the end of 2012. These include but certainly aren't limited to revealing subset data from our melanoma and Merkel cell program and potentially providing updates on deals pertaining to our NeoPulse program.
[CF] Share price isn't there yet, but are there plans on uplisting to the big boards?
[CEO] Yes, the plan to uplist is in our future.
[CF] What sets OncoSec and its platform apart from the rest of the novel cancer therapies currently in development?
[CEO] OncoSec is uniquely positioning itself in the cancer immunotherapy space. For many years, scientists and clinicians have known that many cancers are caused by a dysfunction of the immune system, and as a result they have identified numerous immunological targets with potentially powerful benefits. Unfortunately, until now, the significance of these discoveries in terms of translation into success in the clinic has been disappointing largely in part due to the inability to properly deliver enough of these new agents to elicit a response while maintaining an acceptable level of safety for the patient.
Recently, new methods of delivery have been established such as viral vectors, cationic liposomes or autologous cell delivery, which carry DNA, or molecular instructions, directly to the cell to produce an immunogenic agent. This has been a revolution in cancer drug delivery because this route of administration not only targets the tumor directly, it also reduces the amount of agent required to elicit a therapeutic effect - therefore theoretically leading to potential improved responses and patient safety. Clinical trials using these routes of administration have demonstrated some success, but they have also come with some pitfalls. Early trials using adenoviral vectors resulted in significant safety issues, which have unfortunately delayed the development of this approach. Fortunately, it appears that these safety issues have been resolved and a number of companies have continued to develop immunotherapies using this viral vector approaches, however, it still remains unclear as to the long-term effects for the patient when delivering a biologic agent such as a virus. Cationic liposomes have demonstrated safety and some efficacy as well, however, the transfection efficiency (i.e. the ability to deliver the DNA to the cell with minimal effort and energy) is in question. As a result, clinical trials using this delivery method often require a number of treatments which can extend as long as 6-8 weeks. Lastly, the autologous cell delivery approach has recently received significant attention in cancer immunotherapy because it is the mode of delivery of choice of PROVENGE, the first cancer immunotherapy ever approved in the US. However, the attention received has been quite negative, particularly because it appears that this method, though effect, has proven to be prohibitively expensive for many patients and healthcare providers to consider as a primary or even secondary treatment option.
On the other hand, OncoSec has an established delivery method, electroporation, which provides the same benefits, while reducing the mitigating concerns related to other intralesional therapies. The OMS device uses electric fields to efficiently deliver DNA into cells. These electric fields are inert and dissipate once the electroporation is stopped, thus there is no concern about residual long-term effects. Moreover, the efficiency of delivery using electroporation is significantly better than other approaches. Where other treatments can last several weeks, results from our phase I study demonstrated that only 1-week of treatment could result in clinical benefit for late-stage cancer patients. Lastly, OncoSec's approach is simple and cost-effective. It is being developed as a potential out-patient clinic treatment, and the cost of goods for the company (i.e. device and DNA) is minimal. Taken all together, the ImmunoPulse treatment has demonstrated improved safety, efficacy and cost.
[CF] Sounds impressive and promising. Are any regulatory filings/trials planned for international markets?
[CEO] Yes, the company does expect to eventually target international markets. However, our focus is currently on the success of our ongoing clinical trials and executing on the development plan for the ImmunoPulse program.
[CF] Any final words for current or potential shareholders?
[CEO] In less than two years, OncoSec has started three phase II clinical trials. Two of which have already exceeded enrollment goals. When you look at our data and efficacy results, along with our clinical pipeline and company milestones, it can definitely be argued that OncoSec is extremely undervalued. We are targeting a deadly disease that is only growing and escalating year-by-year, and current treatment options have shown to be expensive with major quality of life consequences. OncoSec has hit every milestone we have set out to reach and plan to continue this trend. We have exciting milestones coming up and plan to announce subset data on our melanoma program and Merkel cell carcinoma program in upcoming months.