Rodman & Renshaw Conference Snapshots.

Advances in healthcare are thrilling. The race for rival solutions for a universal flu vaccine, treatments for cancers and HIV continues. Look at the explosion of ventures countering the harmful quality of life side effects from current cancer treatments! Look at attempts to stem a spreading pandemic. Look at biodefense efforts for us to survive nuclear radiation or   terrorist weapons of mass destruction!

By Robert J. and Brian D. Flaherty

Competing efforts to develop universal influenza, cancer and other vaccines and treatments moved forward. A surprising number of efforts to counteract side effects and other damage caused by current treatments for cancer and other ills popped up. Progress is never a straight line because each new gain comes with unintended consequences which often make patients sick.

Pioneering development of a new drug or treatment is a high stakes struggle. Most medical research winners will be gobbled up by bigger companies at huge stock premiums. The losers will disappear or just try something new.

In between, development company CEOs must endure the agony of knowing their stocks could collapse overnight if the FDA makes an unexpected negative ruling or a rival competitive breakthrough obsoletes all their hopes.

In 5,000 generations or roughly 150,000 years, we have come a long way since our ancestors stopped grunting and finally turned their noises into words. As our combined knowledge continues to increase we will achieve  future progress we can only dream about today. With so many companies researching solutions for similar problems mankind will benefit. Our life spans will continue to be extended. Truly, the best is yet to come!

PharmAthene's PIP of a Merger! Annapolis, MD -based PharmAthene, Inc. (NYSE MKTS:PIP-2.05) President and CEO Eric I. Richman's biodefense company develops and commercializes medical countermeasures against biological and chemical threats in the U.S. Few of us think about this danger but terrorists out there would love to find a way to knock off all the people in a large city. So we have to stay prepared.  

With a recent stock market capitalization of $107 million and trailing 12 months revenue of $23 million, PIP's products protect against anthrax, nerve gas and pesticides, but the company is in the red.

What a difference a proposed merger can make! PIP has a proposed merger with exciting Seattle, WA-based Theraclone. This private company develops novel monoclonal antibody therapeutics for devastating diseases which are a significant threat to human health. The goal of this corporate union is a commercially focused company with a modern platform based technology filled with a pipeline of next generation products. Both companies complement each other. The synergism should drive shareholder value. Products can be developed for commercial markets as well as government biodefense.

Think about this. All future new product development efforts will have potential sources of non-shareholder dilutive funding. Solutions for unmet commercial needs like an HIV antibody could attract large pharmaceutical partners who will offer upfront and milestone payments. PIP's own biodefense efforts will also attract non shareholder dilutive government funding.

The potential contracts which could be captured by pipeline products dwarf PIP's current modest base. Consider a universal flu treatment. Rivals also are after this prize, but PIP believes its unique approach will be the winner. The markets for other potential products and vaccines are also enormous. Sales of existing monoclonal antibody products are in the billions and create a proven regulatory path PIP plans to follow. For more information visit: www.pharathene.com.

Soligenix wins a $32.7 million OrbeShield contract to counter radiation. As nuclear proliferation spreads (not to mention the 100 or so nuclear bombs rumored to be in Israel's basement) the U.S. must be prepared to protect its people from nuclear war or terrorism. If the unthinkable happens, Princeton, NJ-based Soligenix, Inc. (SNGX-2.03) is working to develop OrbeShield, which could be a lifesaver used to treat gastrointestinal acute radiation syndrome.

The U.S. must prepare for other threats too. Anthrax gets most media space because it is easier to use. But terrorists continue to experiment how to distribute ricin, one of the world's deadliest substances. Soligenix is a world leader in ricin toxin vaccine research. In October it submitted a contract proposal which would support a multi-year, multi-million dollar contract if accepted by the government. It is for the advanced development of its RiVax as a vaccine medical countermeasures candidate for biodefense threats to protect the public from biological weapons of mass destruction.

And few of us are aware of a budding pandemic. In Northeast Thailand the Melioidosis infection has a death rate of over 40% and ranks in that region as the third most common death from infectious disease after HIV/AIDS and TB. Melioidosis already is killing in Southeast Asia, South America, Africa, the Middle East, India and Northern Vietnam. It is suspected to be in China and under reported. This incurable infection is spreading out globally with the increase in diabetes. The kill rate is comparable to the Black Death. What if terrorists sent infected volunteers into uninfected countries to  spread this killer more rapidly? Chilling thought.

Fortunately, Soligenix is working to protect us from this trio of very real dangers most people are unaware confront us. It is also working to fight painful  Oral Mucositis, which is damage done by anticancer therapies occurring in 40% of the patients receiving chemotherapy.

With a stock market cap of $38 million, trailing 12 months revenues of $3.3 million and a loss of $6.2 million, Soligenix's President and CEO Christopher J. Schaber told his audience SNGX had just raised $7.l million in the stock market. That is a sign that  its prospects are very  promising. In biodefense, besides development of OrbeShield to protect against radiation, vaccines for pre- exposure to ricin with orphan designation and vaccines for anthrax toxin with orphan and fast track potential are in the pipelines. In bio therapeutics SNGX has other fast track or orphan designation candidates for Oral Mucositis due to treatment of head and neck cancer, pediatric Crohn's disease and unresponsive illnesses like Melioidosis. Breathtaking! For more information please visit: www.soligenix.com.

CytRx hopes s to replace a popular but highly- toxic chemotherapy drug with its new protein- linker compound to treat  brain cancer: Founded in l985 and taken public by Morty Davis' D. H. Blair, Los Angeles, CA-based CytRx Corporation (Nasdaq:CYTR-2.27) is flush with about $44 million in cash. It just netted $21 million from a recent successful secondary where Aegis Capital acted as the sole book-running manager and H.C. Wainwright acted as co-lead offering manager.

This bankroll will enable President and CEO Seven A. Kriegsman to continue developing CYTR's lead drug Aldoxorubicin. If trials continue to go well, this breakthrough could replace the widely used but highly toxic cancer drug Doxorubicin in treatments of many cancers. This chemotherapy drug is effective in killing cancer cells but cannot be used up to its maximum strength needed due to its deadly side efforts on healthy cells.

The situation is unfortunately all too common. A current treatment helps but also does damage. Often the problem is enough of a drug cannot get to the cancer cells without doing serious or deadly harm to healthy tissue. The goal to solve these numerous dilemmas is to come up with an improved product or treatment. The challenge for each new drug or delivery contender is to prove its new answer is safe and that it is superior in effectiveness.

CytRx combines Doxorubicin with an albumin protein-binding linker to create a new drug treatment delivery system. The protein linker brings Aldoxorubicin directly to protein-hungry cancer cells. This means more amounts of Doxorubicin will reach the cancer cells while side effects on healthy tissue will be reduced. A global phase 2b trial demonstrated better overall response for Aldoxorubicin over just Doxorubicin alone used in initial treatment of soft tissue sarcoma cancer with chemotherapy. This drove the stock up.

The FDA granted CytRx a Special Protocol Assessment for a global Phase lll trial using Aldoxorubicin as a second line treatment with soft tissue sarcoma cancer after the patient already has been treated. CytRx also can enroll 28 patients with stage IV brain tumors which cannot be removed by surgery. Doxorubicin does not enter the brain. The hope is that Doxorubicin by being compounded in Aldoxorubicin will finally be able to slip over the "blood brain barrier" that separates the brain from the circulatory system. Tests worked on mice but trials on humans must come next. This is an exciting effort. For more information please visit: www.CytRx.com.

Attack on Plaque by AtheroNova: "High Hopes and Great Ambitions." It's mainly because of our life styles. We eat too much- especially fattening foods and  sweets we should avoid. Lack of exercise hurts. For a few it can be our gene make.  Anyway our arteries get blocked by the buildup of harmful plaque.

Enter early stage Irvine, CA-based AtheroNova Inc. (AHRO-0.42). With no revenues yet and a modest total stock market cap of $17 million this biotech plans to safely reduce or regress our atherosclerotic plaque deposits and improve our lipid (similar to fat) profiles to make a major impact on further reducing cardiovascular disease.

AltheroNova Chairman and CEO Thomas W. Gardner notes  when everyone in the audience (or reading this) was born cardiovascular disease was the Number One Killer and it's still the undefeated champion of death. Satin drugs have reduced that mortality by about 35% and that leaves the remaining 55% as unfinished business. About 90% of all adult Americans have 10% or more blockages. What a fantastic health care opportunity! Vulnerable plaque, the most dangerous kind, is the target AHRO is after.

AHRO uses sort of an internal detergent bio acid compound which has demonstrated dramatic preclinical data. But it must do well in human clinical trials and be proven safe when interacting with satin drugs taken to reduce cholesterol. Its first Phase I safety clinical trial of its lead product AHRO-001 is being conducted in Russia with a licensing partner.

With six to eight months of cash needed to carry on its mission AHRO will have a very busy 2014. Their main mission is the stabilization and compression of plaque-that is what they are.

This is CEO Tom Gardner's fourth public company and his team also has a record of successes. They know what has to be done and how to do it. For more information please visit: www.atheronova.com.

GeoVax: Why develop HIV/Aids vaccines? A critical care company spun out in 2001 from nearby Emery University, Atlanta, GA- based GeoVax Labs, Inc. (GOVX-0.39) is a biotech developing vaccines to prevent or fight human immunodeficiency virus (HIV) infections that result in AIDS. There must be two focuses, insists President and CEO Robert T. McNally. A vaccine to prevent HIV and a vaccine for those already HIV positive.

Many may think the battle against HIV/AIDS is over.  McNally stresses that it is not. Many think HIV is no longer a medical issue because those infected just take their medicine. While many live a nearly normal life, they never get rid of the virus.

Globally over 34 million are already infected with 2.5 million new infections each year. In the U.S. of the roughly 1.2 million who are HIV infected only a certain proportion are diagnosed and get on a regimen. That leaves about 25% who don't have control of their virus or are actually carriers of the disease to spread the virus. "That is why having a vaccine is really the only true way to eradicate this problem globally," insists CEO McNally.

The big medical money lies in treating patients in the developed nations. These are huge potential markets: $3 billion for a vaccine which can prevent AIDs and $8 billion for a therapeutic vaccine. With a recent market cap of $8.7 million GOVX has vaccines under current development to address the clade B subtype of the HIV virus which is the common one in the U.S. and Western Europe. While others' trials have failed and some larger rivals have dropped out, GeoVax's own trials, which are mostly National Institutes of Health sponsored, are picking up speed. For more information please visit: www.geovax.com.

ERGO is what modern man is missing! Entia Biosciences CEO Marvin S. Hausman of Sherwood, OR-based Entia Biosciences (ERGO-0.71) has a big idea at his tiny tot with market cap of only $5.5 million. Our food is making us sick.

What to do? We can't stop eating, but his start-up will provide some of what we are missing because of mankind's environmental missteps.

A NYU educated transplant surgeon turned entrepreneur, Hausman reminded his audience of  his two past successes acquired by larger pharmaceutical firms.

At 71 he is no longer a fan of chemical treatment of disease. Instead he has turned to developing medical foods and supplements. His ERGO is a food science biotech in Nutrigenomics. That means providing nutrition to program our genes or genetic background to address deficiencies in our modern diet. Restoring mankind's lost balance can help us (and horses) regain the health nature meant for us to have.

Sounding like a lecturer from your college days, here is his vision. Changes in modern agricultural practices and dietary behavior have significantly reduced the availability of vital nutrients that are genetically acquired to live longer and healthier lives. The mission of Entia is to scientifically balance and patent the benefits of these missing nutrients and commercialize them into proprietary medical food and other supplemental solutions that address multi billion market opportunities in healthcare, beauty (growing hair) and agriculture. He argues providing balance in the body could help offset the devastation of diabetes, Parkinson's and Alzheimer's.

Sounds unbelievable, but hear him out. As descendants of hunter gatherers our bodies are programmed to store vital nutrients to counter biological stress and maintain healthy cells, tissues and organs. However, as we have modified our diets through programmed farming, herbicides and pesticides there has been a dramatic increase in obesity and chronic diseases.

Only 18% or so of our diseases are genetic, Hausman claims. Over 80% are environmental and we are causing them ourselves. Using Nutrigenomics Enita is starting by trying to reverse two fundamental deficiencies in our modern diet. (There are lots of others.)

First is Ergothioneine, ergo for short, a stable highly potent antioxidant which is found in Russia. Significantly ERGO was chosen for Entia's stock symbol. Researchers in Germany discovered we all have a human gene used to be a specific transport for ergo and concluded there must be a significant role for ergo in all human health in protecting mitochondrial DNA from damage industry by free radicals.

In 2010 Enita acquired world-wide exclusive diagnostic and therapeutic rights to the Ergo Transporter from the University of Cologne and has filed patents on the use of ergo in the treatment of anemia, diabetes, auto-immune diseases and neurodegenerative diseases.

Entia has created Ergo-D2, an optimized blend of L-Ergothioneine and vitamin D2 ingredients to use in dietary food supplements and organic food products. Hausman notes the vitamin supplement market is astronomical but how much stays within your body and really works? He claims that ergo in pre-clinical trials has helped lessen an important disease. "I think we are the first company to show that a medical food, not a chemical, not a drug, can modify a devastating disease."

Entia is just starting out and has many more ideas than can fit in this tiny space. For more information please visit: www.entiabio.com.

DARA's helpful relief from cancer patients' treatment woes. Raleigh, NC -based DARA BioSciences, Inc. (Nasdaq:DARA-0.47) specializes in a space largely ignored by the oncology industry. DARA is focused on providing supportive products to relieve the mischief of cancer treatment side effects in patients. It is an oncology supportive care pharmaceutical company dedicated to providing healthcare professionals a synergistic portfolio of medicines to help cancer patients adhere to their therapy and manage side effects arising from cancer treatment.

On Oct. 22 DARA raised $2.3 million to expand its sales force. On Oct. 28 DARA announced plans to enter into an agreement with Alamo Pharma Services which will provide DARA with a 20 person dedicated sales force for the promotion of DARA's three existing commercial products Soltamox, Gelcair and Bionect. Mission Pharmacal (Alamo's parent) will also expand DARA's product line with a strawberry flavored solution for the treatment of osteoporosis, iron therapy for anemia and a protective oral spray for the treatment of anemia.

Tiny DARA is a classic case of trying to do too much too soon. It launched its three synergistic supportive products with too small a base where five to seven sales people had to cover the entire U.S. Their concept was that somehow all three supportive products could be linked together. Sales didn't flow, but were just a disappointing trickle. Now DARA will have many more people and more products to sell nationwide.

CEO David J. Drutz is sure his three lead products properly marketed will succeed. That is because each is badly needed. DARA holds exclusive U.S. marketing rights to the Soltamox. This is the only liquid form of taxoxifen citrate. Taxoxifen is vital in controlling breast cancer by reducing estrogen on which cancer feeds. Patients who have trouble swallowing need to take a liquid. In addition others just prefer a liquid over a tablet.

The second product where DARA licensed the U.S rights is Gelclair. It is an alcohol-free bioadherent oral rinse gel for rapid and effective relief of pain associated with oral mucositis caused by chemotherapy and radiation treatments. The coating protects the skin so patients can continue their chemotherapy.

The third product DARA markets is Bionect, a topical treatment for skin irritation and burns associated with radiation therapy. Taken three times a day it coats the surface of the mouth and allows for the critical process of eating and drinking so cancer patients don't lose weight. It is hard to eat when every bite hurts.

DARA also wishes to identify a strategic partner for the clinical development   of a yet to be named drug so far called KRN5500. DARA believes this drug can relieve the pain from nerve damage which accompanies certain chemotherapy drugs The FDA has designated KRN5500 as a Fast Track Drug and DARA is seeking orphan status.

The concept of a company built around providing synergistic supportive products to relieve the problems triggered by cancer treatment is great. With a total stock market cap of under $13 million and trailing 12 months sales of only $151,000, DARA is still a concept company. It needs to perform. If sales roll in and profits follow, DARA will be a big winner.

For more information please visit: www.darabio.com.

"A Very Important Day for Inovio!" Of the nine biotechs featured in this issue Blue Bell, PA-based Inovio Pharmaceuticals, Inc. (INO-1.75) with the highest total market cap of $332 million is one of just two we have written about earlier. In fact, we have followed its over 30-year Perils-of- Pauline's adventures since former surgeon turned entrepreneur former CEO Avtar Dhillon rescued INO from possible bankruptcy.

As a practicing doctor Avtar understands that while surgery is often the best solution to treat cancer it comes with harmful side effects. Healthy tissue is cut off. Lots of functions like speech not to mention a breast or in the case of prostate cancer male potency can be lost. Likewise to reach cancerous cells, toxic radiation and chemotherapy often pass through the entire body doing terrible nerve damage along the way.

Worse of all, when what's survived of the cancer drug finally completes its marathon destination and reaches the sick cells the drug encounters an entry barrier and has trouble getting inside the sick cell to kill the cancer. That is because each cell has its own protective cell membrane to keep invaders out.

Cancer surgery -not to mention chemotherapy and radiation-is barbaric. Avtar thought there has to be a better way and Inovio embraced his choice. Electroporation can electrically open pores in the protective cell membrane injected in tandem with a cancer fighting drug put directly into the cell area by a needle. The result can be a lower drug dosage used and less side effect damage to healthy tissue but over 1000% more of the drug penetrating and entering the sick cells to kill the cancer.

Alas an emerging company can't do everything; it must pick and choose wisely to succeed. In recent years under the current CEO Inovio's main effort has ambitiously focused on developing DNA vaccines for cancers and major infectious diseases. These are major efforts and take all the company can give.

The application of using electroporation to deliver a chemotherapeutic drug as an alternative cancer to surgery was sitting on the shelf because of this strategic decision to sharply focus the use of Inovio's management and capital on the vaccines. The tumor destruction technology was hidden behind Invoio's vaccine development banner.  

In 2011 frustrated Avtar Dhillon created and started up OncoSec Medical (ONCS-0.27) licensing from Inovio rights to try to spread the use of electroporation as an alternative to cancer surgery. With Avtar's nephew Punit Dhillon as CEO, ONCO also is pioneering using DNA in electroporation injections to prove it creates immune response in hard to reach parts of the body to fight spreading metastasized cancer.

ONCO faces stiff competition from older toxic cancer drugs used in new delivery systems which attract the drugs directly to cancer cells. Also getting an electroporation injection medical device approved in the U.S. has been slow going. Paraphrasing the old story teller at the end of the Jungle Book what happens to ONCO will be another story.

Meanwhile, since ONCO went its own way, Inovio under President and new CEO J. Joseph Kim has made exceptional continuous progress.

One of the good things about attending conferences is you can see a CEO in action and how he or she handles themselves or reacts to difficult questions. Until this presentation I had never seen Kim.

At Forbes my late great editor Jim Michaels always looked forward to seeing people behind the corporate logos. I can remember Jim now as he would ask, "What's he got? Why is the company so different with him in charge?"

Energy is the answer for this CEO. Kim is a trim, diminutive explosive bundle of energy. You can feel it. Now I understood why Inovio has been moving ahead and why he can make difficult decisions vital to success.

After being in a funk for years, currently INO stock is active but very controversial. At a recent price $1.75 it is down 42% from its 52 week high of $3.03 but up 298% from its low of $0.44. Bulls and bears battle over every short term move. Shorts are flyspecking management moves and warning that most drugs in development never reach commercial sales.

Yes it takes years to build a company except where money men dress up a corporate bride for a quick marriage. So let us look at what Kim is trying to do. Many other companies have tried and failed so far developing DNA and other vaccines for the big problems like cancer and a universal flu vaccine. But the rewards for success are huge and Inovio is after them.

Good news! Kim started his talk off by announcing "a tremendous deal." With a mammoth total stock market value of $235 billion  Roche Holdings AG (RHHBY-69.34) will partner on two of Inovio's preclinical candidates. Roche's  $422 million payment would be $10 million upfront and the rest in potential Phase I, II and III milestone payments plus double digit royalties if the commercial stage is achieved.

This is a company-making deal for tiny Inovio! Kim made the right decision focusing INO more narrowly.

"Our job is to save lives and to maximize shareholder growth and value," Kim went on. "We just proved that in the first of perhaps many deals to come that this deal is a great validating central approval from the world's greatest preeminent oncology company-Roche. They have exclusively licensed two of our near clinical candidates INO-5150 targeting prostate cancer and INO-1800 for hepatitis B therapy. (Roche will pick up most of the further costs of developing these drugs.) I'll have to tell you that more great things are about to come in the near future."

Constantly using  "best in class", Kim expanded that Inovio is revolutionizing vaccines to prevent and treat today's cancers and challenging infectious diseases. Its vaccines in combination with its proprietary electroporation delivery are generating best in class immune responses with therapeutic T-cell responses exceeding other technologies in terms of magnitude, breadth and response rates. Inovio's lead vaccine, a therapeutic against Human Papilloma Virus sexual disease caused pre-cancers and cancers, is in phase II. Other Phase I and preclinical programs target prostate, breast and lung cancers as well as HIV influenza, malaria and hepatitis C. The commercial markets for treating each of these diseases are in the multi-billions.

Accompanied by more of his top management than anyone other presenter, Kim went over their accomplishments and concluded, "It's the people who make our company work better than anyone else."

For more information please visit: www.inovio.com.

Champions Oncology: Of Mice and Men! "The problems of oncology are simple", says CEO Joel Ackerman of Hackensack, NJ-based Champions Oncology, Inc. (CSBR- 1.25). "Most drugs deliver little or no benefit to most of the patients who take them. Response rates are low."

His hope for cancer victims comes in the form of mice. He heads a unique personalized oncology (cancer treatment) company with a unique Tumorgraft Technology Platform. It is personalizing oncology both for individual patients and their doctors to help determine drugs to be used and in the process to create "a Living Tumor Bank." This will assist in personalized treatment for individual patients and/or the development of new drugs by pharmaceutical companies like Teva Pharmaceutical Industries.

Noting others implanted human tumors in mice earlier but without much success, Ackerman says, "We have a Champion Tumorgraft Platform. We take a full fragment of the human tumor and implant it in immune-deficient mice."

Then these tumor grafts can be used as models to predict therapy for individual cancer patients from which we have taken those tumors.

"How are we doing?" he asks his audience. Greater than a 90% rate of predicting how patients will respond. When the patient was given that cancer drug tested in mice with their own tumor patients  responded 63 out of 68 times as predicted. Naturally this means doctors could use the cancer drugs which look as if they would work first and use the supposed duds last. The difference of testing in mice could save lives.

The growing numbers in Champions' Living Tumor Bank can provide studies to pharmaceutical companies on how to develop their drugs going forward. So often millions are wasted doing Phases I and II when Phase III-whether the drugs works on people-is a big flop. Results from these living tumors in mice could provide helpful hints on what will work and what will not. This advance heads up would save drug developers a pile.

With trailing 12 months revenues of $9.3 million and a market cap of about $87 million Champions is still a very young company. Three years ago when Ackerman joined the company it served one patient a month versus 300 today. The growth is because Champion can look at several different drugs on behalf of each patient thanks to results in the implanted mice.

Besides the U.S. offices are in Europe, Israel and Singapore because the company needs scale as quickly as possible. Champion needs more patients to better provide validation and proof to attract more patients, doctors and above all payers. The mice process is not yet reimbursable. Results must demonstrate that this is a test that is worthy of being paid for.

As more patients come in and donate their tumors Champions Living Tumor Bank will not only grow bigger but have more diversity in the types of cancers. This will make the bank become more valuable for those research studies on using existing drugs or developing new drugs.

So much cancer therapy makes make patients sick. Wouldn't it be wonderful if because of some tiny mice the drugs initially selected for treatment also worked? For more information please visit: www.championsoncology.com.

A doctor who has a mouse who just might save your life or mine? How can I top that? I won't even try. That's all, folks!-RJF