NEW YORK, NY / ACCESSWIRE / April 15, 2016 / Cancer news seen on all types of media - television, radio, print, webinars, investor and scientific meetings, and grass root blogs, is covered for a reason. Up to 40% of people in the US alone develop cancer, according the National Cancer Institute. Breast cancer and leukemia get the lion's share of attention, but other cancers are just as dangerous. I believe Heat Biologics (HTBX), one of the most forward-thinking and innovative companies in cancer immunotherapy geared toward cures for non-muscle invasive bladder cancer (NMIBC) and non-small cell lung cancer (NSCLC), will be a winner in the race to bring medicine a giant step forward.

Heat's bladder cancer vaccine, if approved, could generate annual revenues of $1 Billion. Today, $4 Billion per year is spent on treating bladder cancer patients in the US, according to the National Cancer Institute, a little known fact. Bladder cancer is the most expensive of all cancers in terms of lifetime treatment costs and is the 5th most common cancer in the US. The NSCLC market is even bigger - expected to rise to $7 billion worldwide, growing at 5% per year.

Popular media tends to overlook bladder cancer, mostly because new treatments haven't been approved in 25 years. Urology is often considered a stodgy, mothballed medical science that doesn't embrace new technology, preferring a 'watch and wait' approach. This is ludicrous and bad for the patient, whose cancer could progress while the urologist sits on his hands and does nothing. Almost 500,000 Americans live with bladder cancer, the majority having the type Heat's drugs can cure. Reoccurrence happens often. Five-year survival rates are low. Currently the only effective treatment for NMIBC is removal of the bladder.

For patients who don't want to lose their bladder, Bacillus Calmette-Guerin ((BCG)) vaccine is the only treatment option. Based on bacteria used to stimulate the immune system, originally approved in 1990 to prevent tuberculosis, it stops tumor recurrence by burning the inner lining of the bladder to kill any remaining cancer cells after malignancies have been surgically removed.

Aside from showing less than desirable efficacy, other major problems exist: 25% of people taking BCG cease treatment due to toxicity. BCG causes painful and bloody urination, incontinence, groin pain and high fever when infection sets in, which is often. The 'light' side effects are vomiting, stomach pain, rash and dizziness. There's a long list of drugs BCG interacts with, and women are required to avoid pregnancy.

To make matters worse, manufacturing problems at Sanofi (NYSE:SNY), makers of BCG created a worldwide shortage when FDA found mold within the plant. Merck (NYSE:MRK), the only other producer of BCG had its own production problems. In an interview with Forbes, Dr. Joe Eid, Merck Oncology's Head of Global Medical Affairs, stated batch production of BCG was challenging. Reportedly, it takes three months for a BCG batch to mature and there is no way to tell if the yield is good or bad during that time. These problems force urologists to find new ways to treat patients and will benefit Heat.

Here, Heat comes in, and strong. Heat's bladder cancer vaccine HS-410, if as effective in later trials as it's been in early ones, can save lives and improve quality of life because side effects do not exist. The first immunotherapy in clinical trials for bladder cancer, HS-410, when approved, could easily generate more than $1 billion in annual revenues in the US. This, based on the 400,000 Americans who live with NMIBC, assuming a very modest $2500 per year in HS-410 treatment costs. Top urologists, FDA recognizing an unmet medical need, and insurers - always looking to save a buck because Heat's technology is cost-effective - have taken notice. Given the current high cost of bladder cancer treatment, I believe all parties are rooting for approval of HS-410.

FDA's coveted Fast Track Designation was approved for HS-410 last March, underlining the desperate need of people with this dreaded and unresolved sickness. The Society of Urologic Oncology Clinical Trials Consortium, a cooperative group that represents urological oncologists from over 160 clinics in North America, signed an agreement with Heat to enroll patients in its current Phase 2 and planned Phase 3 bladder cancer trials.

For NSCLC, Heat is teaming its HS-110 with Opdivo, Bristol-Myers Squibb's (BMY:NYSE) checkpoint inhibitor to power up immune response. Popular checkpoint inhibitors approved for only a handful of Big Pharmas disappoint doctors when just 40% of patients respond, and treatment must be done in the intensive care unit (ICU) of a hospital, using materials that come from any particular patient, while Heat's therapies are not required to. Medical theories say combination therapies will dominate lung cancer treatment in the future, and I agree. Unhealthy radiation and noxious chemotherapy are quickly becoming things of the past. Mid-stage trials for HS-110 are ongoing with rapid patient enrollment. I expect good news from these.

Heat's drugs, cancer vaccines are super-charged through a remarkable technology platform called ImPACT (Immune Pan-Antigen Cytotoxic Therapy), finely-tuned to hone in on malignancies and even reverse what tumors do best - suppress the immune system. ImPACT, an immunotherapy which can be applied to any cancer, transforms living allogeneic (off-the-shelf) human cancer cells into miniature pumps that continually secrete cancer antigens to activate a patient's own immune system to destroy cancer cells - that's the basis of why it works.

Bets are on Heat having very successful outcomes in all its clinical trials as they progress in their respective phases. Early results are good. Later results should be even better. News is coming up that will move the stock. Final results from Phase 2 bladder cancer trials are due to be announced in Q4, along with preparations to enter Phase 3 next year. More data from Phase 1b trials in NSCLC, that previously revealed 100% safety and astonishing efficacy, are due in Q4 as well.

Heat's current market capitalization is about equal to its cash. The company reported it had approximately $12 million in cash and equivalents on December 31, 2015 and raised an additional $6.8 million in March.

With trimmed costs and focused strategy, I believe this stock is highly undervalued, under the radar, and a huge opportunity.

RAY DIRKS suggest that Readers/Investors place no more that 1% of the funds they devote to common stocks to any one issue. It is best to diversify.

About Ray Dirks

Ray Dirks came to Wall Street with Goldman, Sachs & Co. in 1963 where he was established as the leading insurance stock analyst dealing with institutional investors and high -net worth investors both in the U.S. and internationally.

In 1973 Ray uncovered the biggest Ponzi scheme of the 20th century, the Equity Funding fraud. Over the years Ray has expanded his stock market research to include Healthcare Stocks and Special Situations. Ray has written two books, "The Great Wall Street Scandal" and "Heads You Win, Tails You Win," published by McGraw-Hill and Bantam Books respectively. He continues to provide research to institutions and individuals, and he manages money for some individual investors.

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SOURCE: Ray Dirks Research