This is a great analysis and I wish I could afford this service! CB Insights does an outstanding job of analyzing the markets both public and private. Click: http://www.cbinsights.com/blog/trends/capital-efficient-venture-capital-value-creatio this particular analysis is telling in two ways, first it tells us that the market valuation increase versus the amount of equity capital raised in an IPO or M&A exit of over $100MM is 38 to 1! That means the companies that raised $1 in equity at the IPO had an average of a $38 in valuation. Second, not a bad ramp, indicating that maybe the valuation slump really is gone? Who could forget the disastrous decade since the internet bubble burst, followed by the Biotech bubble and then the double whammy of the 2007 RECESSION? Since this bull market started in 2009 (recent opines from Security Analysts who by the way didn’t see it at the time!), the S&P 500 index has gone up 173% or about 34.6% average per year (most of that gain has been in the last couple of years) so the Bull is full on. The 15 companies that were evaluated were mostly internet and social media or social network companies so the data is a little skewed when trying to extrapolate this to the healthcare sector and facts are that there is no equity investment capital to extrapolate to the healthcare market, Drugs, Diagnostics and Devices is still paltry. Steve Burrill Click: http://www.burrillandco.com/ at the recent Moffitt Cancer Center meeting in Tampa, FL commented that only “1 out of 150 life science startups get VC funding”. A really poor funding system and a paltry pool of capital for fueling new life science and helping to create new technologies, lower health care costs and treat diseases in the best market in the world. A second comment by a retired J&J Venture Capital Fund manager is that the VC arm of J&J “…turned down 99% of the business plans.” What’s that say about VC funding, industry funding? I’ve said this several times in meeting Deval Patrick, our esteemed Governor “…there is a better way to fund Biotech.” Can we blame the VC’s? Of course not? 160 characters on a cell phone is much safer company to fund and faster to ROI than funding a multi-hundred million dollar drug development program to treat some obscure disease…Am I being sarcastic? Yes of course!
The GLG Pharma STAT Blog
GLG Pharma, LLC has a pharmaceutical and diagnostic product engine that has already generated three lead compounds for interrupting the STAT3 proliferation mechanism in targeted diseases. The Company and its partners, not-for-profit foundations, have selected the target diseases that have no approved treatment regime at this time. Besides combining a diagnostic with a drug therapy for liver cancer patients with Alpha-1 antitrypsin deficiency, the compounds can also be used to treat Polycystic Kidney Disease (PKD) and the underlying hypertension associated with the advancing disease. We are seeking the support of both the Alpha-1 Foundation and the PKD Foundation along with their patient advocacy and scientific research groups to help raise money for GLG Pharma and their foundations to complete both missions: Get Approved Therapies to Market for Alpha-1 and PKD patients as soon as possible!
In addition, the National Cancer Institute's Prevent Program is supporting the evaluation of GLG-302 for long term prevention in Breast Cancer patients. The drug candidate, GLG-302 is performing remarkably well in NCI sponsored evaluations and is showing little to no dose limiting toxicities at very high dose (500 mg/kg when GLG believes that the therapeutic treatment is 25-75mg/kg) and long term treatments (now out to almost 90 day toxicity study with no side effects in the mouse and rat) in the animal models is very encouraging. GLG and the NCI are very excited by these results and will push together to make the therapy available to Breast Cancer patients for long term, preventive care therapy.
The real advantage for GLG therapies is a tailored diagnostic test to go along with the therapeutic treatment. This combination of Drug and Diagnostic along with the evolving cancer genetics data and the patient’s genetic information, all this information can add to the focused treatment for specific diseases. While cancer remains the single largest therapeutic area, there are now well over 800 cancer drug therapies in development. Focusing on rare and under treated diseases helps speed products to market and then GLG will expand into therapies for cancer and the development of diagnostic tests. Since venture capital is nearly always focused on return on investment, capital available for long term therapy treatments has diminished considerably. GLG and Poliwogg believe that there is a better way to fund Biotech but we need your help, support and investment. If you don’t invest in GLG, then donate to either the PKD foundation or Alpha-1 or do both. Your investment will be well managed and your dollars well spent!
Poliwogg is a new kind of funding vehicle and we are using Regulation D 506(c) regulations. Want to find out more about the team at Poliwogg? Or want to listen to Greg Simon? Just click the links and your there!
The most important difference is that GLG Pharma are not starting from scratch. We are veterans of many drug discovery, development, launch and successful drug treatment products. Many new companies that were launched and are being launched today in the Biotech and Pharma markets; were and are, started with such marketing and funding concepts as:
- Transformational (new technology that changes an application within a defined market and industry)
- Paradigm Shifting (new technology that changes an industry)
- Innovative Transformations (new applications that open new markets of established market, technology and industry)
- Ground Breaking Technologies (never before discovered technologies that opens completely new markets)
- Lots of Investment Capital (Drugs, devices and diagnostics all require large amounts of capital)
- Lots of equity dilution (founder’s equity is usually reduced to 1-5% of holdings after IPO’s, as a general rule)
GLG Pharma was started with a much simpler and understandable strategy for achieving drug and regulatory approval, a strategy that has two principles. Know your science and know your patient, coupled with shorter to market revenue generating products.
Many drug companies today have that strategy, but they are already funded. These companies are now selling products into a market and now they have become post-transactional savvy, compared to when they were first funded or seeking investment. So what has changed in the Biotech and Pharma world? In our opinion, a lot has changed.
Pharma and Biotech companies and startups have evolved as have the Pharma and Biotech markets in which we all operate. Today, investment for transformational, paradigm shifting and ground breaking technologies out of the high end institutions is still happening and will continue to do so; but the real question is; is this how a new Biotech and Pharmaceutical company should be launched? There is a reduced risk way to fund Pharma and Biotech. At GLG we have combined near term revenue opportunities in cancer with our pipeline development strategy. Our focus remains on the science and the patients, supported by investment and revenue from targeted approved products for prescription and over the counter products. These early stage revenue generators can help fuel and reduce the need for additional investment and subsequent dilution.
Each disease, whether it is AIDS, Influenza, Cancer, Schizophrenia, Alzheimer’s, Autosomal Dependent Polycystic Kidney Disease or any other terminal or chronic illness, have families and friends concerned for the patient. The patient is attended to by a cadre of physicians and clinicians who manage the disease and its treatment. It is a very complicated and sometimes a frustrating process, especially in the United States and also in Europe. It is frustrating not only for the patients and their families, but also for startup companies and entrepreneurs who want to launch new products and therapies for those patients. GLG’s focus on the science of disease and a patients therapy in treating proliferative diseases that have p-STAT3 as a mechanism, could help usher in new lower toxicity drugs that improve overall patient care. GLG can also monitor p-STAT3 levels in patients with a disease, alerting clinicians and patients as to the success or failure of a treatment regime.
Since the second great depression; starting in 2007 with the hedge fund collapse, life science technology companies; especially the Biotech and Pharma industries have been declining in value. However, the decline shortly after 9/11 in 2001; drug, biotech and diagnostic stocks and the startups have been on the proverbial slide down the slippery slope of little to no liquidity. Low liquidity for investors, low liquidity in equity markets, little to no availability of capital in bond markets. Adding to the downward spiral is the apparent unending series of regulatory disasters that have left the investment community shying away from anything remotely represented by or requiring an FDA filing and approval. Part of the regulatory perception problem was caused by large Pharma and large Biotech, by sometimes ignoring their responsibility to self-regulate their products, operations and clinical development in accordance with FDA and EMA regulations. A few very visible FDA actions against the industry can affect the entire investment and market landscape, Vioxx, Genzyme’s production failures and a whole host of other disasters, tangibly affected the investor psyche.
GLG’s management team have a performance history; out of the 16 drugs that have been developed and submitted to FDA review and approval by our collective team of professionals and the several FDA site audits of our former operations, 15 of those drugs were approved and none of us received or were cited in a FDA audit for any violations of 21CFR guidelines.
The same principle of respect for the regulatory process, applies to our respect for the patients; that our drugs will be treating. GLG are looking for a series of molecules that will be efficacious for the treatment of patients and have as little side effects as possible. All drugs have side effects that affect some or all patients, so having a chemotherapy agent that does not have side effects are rare. So why did we choose GLG-302, GLG-801, GLG-202, GLG-101 and 401 to advance into clinical development. GLG-302 is a compound that has proven itself in our pre-clinical evaluations as well as by a host of independent laboratories around the world. We have encouraged other laboratories to duplicate our findings and we have built up a successful and prominent following of researchers that now believe that inhibition of p-STAT3 is one of the keys to shutting down cancer cells that have become resistant or are proliferating at an exponential rate.
We are also looking at GLG-302 in combination with other standard chemotherapy agents as this compound has reversed chemotherapy resistant cells in vivo and in vitro, allowing a second course of treatment which eradicates the resistant tumors. This research has also led us to study cancer stem cells which survive standard chemotherapy treatments, these cancer progenitor cells go into a sort of remission and then spread throughout the body and start reproduction at a much higher rate. Cancer stem cells are resistant to chemotherapy treatments and are believed to be one of the major cause for cancer cell metastases. Cancer stem cells appear to be 100% up regulated with p-STAT3.
GLG Pharma: Drugs, Diagnostics and Devices- delivering more than a drug ©
GLG Pharma’s STAT3 Signaling Inhibitor Selected for NCI’s PREVENT Cancer Preclinical Drug Development Program.
Jupiter, FL. July 16, 2013 – GLG Pharma, LLC announces scientific and financial resources of the PREVENT Cancer program of the National Cancer Institute of the NIH have been approved to study the effects of its STAT3 signaling inhibitor, GLG-302 as a breast cancer chemopreventive. The PREVENT Program is a National Cancer Institute-supported pipeline to bring new and novel cancer preventing interventions and biomarkers through preclinical development towards clinical trials.
The selected GLG Pharma study entitled “Evaluate GLG-302 in the Prevention of Mammary Cancers in the ER(+) Methylnitrosourea Rat Model and the ER(–) MMTV-NEU Mouse Model” using well established models of breast cancer will focus on the following areas:
1) Evaluate the MTD, effect on STAT3 in normal mammary tissue and oral efficacy of GLG-302 in mouse models of breast cancer.
2) Assess effects on tumor latency, incidence, multiplicity, and body weight.
This key study is an in-depth continuation of preliminary studies already conducted by GLG Pharma. In these studies GLG-302 was shown to suppress tumor growth in a number of animal models, to have a wide therapeutic index and was well tolerated.
In recommending approval of resources for the project, the PREVENT panel of external experts observed “This pathway is implicated in multiple cancer types. The value of the study goes beyond validating the pathway.”
According to the Centers for Disease Control and Prevention, aside from non-melanoma skin cancer, breast cancer is the most common cancer among women in the United States. It is also one of the leading causes of cancer death among women of all races. In the US in 2010, over 200,000 new cases and more than 40,000 deaths due to breast cancer occurred. The greatest achievement for this disease would be to treat high risk women who don’t have detectable breast cancer with an agent that is safe and well tolerated, and would prevent malignant conversion of normal breast cells to cancer.
Hector J. Gomez, MD, PhD, Chairman and CEO of GLG Pharma commented: “The NIH grant confirms the high level of scientific interest and the significant potential of our patented STAT3 signaling inhibitors in cancer prevention. This research program will provide important findings and form the basis for further evaluation and development of new therapeutic and chemopreventive agents in the prevention of breast and other cancers”. STAT3 inhibitors are important targets for cancer prevention and cancer treatment. Developed in collaboration with the Moffitt Cancer Center in Tampa, FL along with a companion diagnostic test, STAT3 targeting and monitoring is a program that the NCI has spent significant early research money to evaluate and advance. GLG is advancing these discoveries to the clinic and approval.
About GLG Pharma
Founded in 2009 and located in Jupiter, Florida, GLG Pharma, LLC is a privately held, early stage, biotechnology company developing personalized therapies for patients with cancer and other proliferative diseases. GLG Pharma’s therapeutics are expected to aid in the treatment of a wide variety of cancers and address unmet needs in the multi-billion dollar anti-cancer market with potentially greater efficacy and fewer side effects than existing therapies. For more information on GLG Pharma visit: http://www.glgpharma.com
Institute for the Commercialization of Public Research Funds Jupiter Biotech Company
GLG Pharma Approved for Seed Capital Accelerator Program
Boca Raton and Gainesville, FL – June 1, 2012 - The Institute for the Commercialization of Public Research (the Institute) announced today that it has provided early-stage funding to GLG Pharma (GLG), a Jupiter-based company developing treatments based on technology licensed from the Moffitt Cancer Center in Tampa, for cancer and other proliferative diseases wherein cells grow or multiply rapidly. The Institute works with Florida’s research universities and institutions to support new company and job creation, and participants in the program must match Institute funding with private capital raised from angel investors and other sources.
GLG Pharma is developing a series of patented inhibitors of activated Signal Transducer and Activators of Transcription 3 (p-STAT3). The p-STAT3 protein is encoded by the STAT3 gene and is unique in the ability both to respond to extracellular signals and to regulate other genes directly. In normal cells, the formation of the p-STAT3 protein is switched on and off in response to signals that control cellular function. The presence of persistent levels of p-STAT3 is thought to play a key role in a number of diseases including cancer, psoriasis, polycystic kidney disease and Crohn’s disease. GLG Pharma’s initial therapeutics are expected to aid in the treatment of a wide variety of cancers with potentially greater efficacy and significantly fewer side effects than existing therapies in the $75-80 billion anti-cancer market.
GLG’s Executive VP Michael W, Lovell, Ph.D. stated that “this funding will enable us to advance the development of three product candidates and expand our collaborations with other research institutions in Florida. We appreciate Florida’s commitment to advancing the Life Sciences sector and these funds will enable us to raise additional capital to support our product commercialization efforts.”
“Companies like GLG Pharma demonstrate the promise of a diversified, knowledge-based economy in our state, and we are pleased to offer programs that help early-stage companies such as GLG Pharma achieve critical development milestones, said Jamie Grooms, Institute president and CEO. “GLG Pharma also represents the statewide connectivity provided by the Institute, which facilitated bringing together technology from West and Central Florida, management from Northeast Florida, and funding from Southeast Florida.”
About the Institute
Founded in 2007 as a non-profit organization, the Institute is Florida’s One-Stop-Shop for investors and entrepreneurs who seek to identify new opportunities based on technologies developed through publicly-funded research. The Institute delivers programs that facilitate new venture and job creation through commercially-viable technologies in major industries that are driving the global economy. The Institute also administers the Florida Research Commercialization Matching Grant Program launched in 2010, and the Seed Capital Accelerator Program launched in 2011. For more information, visit .
About GLG Pharma
Located in Jupiter, Florida, GLG Pharma, LLC is a privately held, early stage, biotechnology company founded in 2009 to develop personalized therapies for patients with cancer and other proliferative diseases. GLG Pharma’s therapeutics are expected to aid in the treatment of a wide variety of cancers and address unmet needs in the multi-billion dollar anti-cancer market with potentially greater efficacy and fewer side effects than existing therapies. For more information on GLG Pharma visit: http://glgpharma.com
STAT 3 publications are numerous and we hope that the following links will help you better understand it's importance in cancer cell metabolism and cancer cell death. Inhibiting STAT 3 is an important mechanism for encouraging cancer cell death. Using STAT 3 inhibitors with other traditional cancer chemotherapy should help improve patient outcomes. Linking a diagnostic with a STAT 3 inhibitor will also help reduce patient side effects as well as potentially improve patient outcomes.