Looking for Some of This?

[Update | Add Domain Associates, Domain Partners, VIII $500M to the early-stage drug and device sectors; bringing recently closed funds up to $1,925M]

Recently Boston, MA-based Excel Venture Management announced the close of the new $125M Excel Medical Fund. The portfolio is a planned balance across healthcare IT and services, diagnostics, and medical devices, plus life science platforms that address adjacent markets which may include energy, chemicals, defense and agriculture. It is made unambiguously clear that single molecule drug companies need not apply – for such an approach is not of interest to their principals. Initial investments are in the $1M to $5M range and it appears at least five investments have been made to date, these include 1. Aileron Therapeutics (who is developing Stapled Peptides, an entirely new therapeutic modality that can target all human diseases) 2. BioTrove (who provides micro- and nano-scale technologies to the research and diagnostics markets) 3. Dormir (an integrated provider of sleep diagnostic services, therapy and equipment) 4. MedVentive (provider of healthcare IT business intelligence solutions) and 5. Synthetic Genomics (who is designing metabolic pathways for the production of biochemicals and next generation biofuels from a variety of feedstocks).

Additional life science funds that have closed within the last twelve months include Essex Woodlands Ventures $900M Fund VIII which invests across the spectrum of drug, device and service companies in North America, Europe and Asia, and Morgenthaler Ventures checked in with their $400M Fund IX, who in their press release indicated a continued focus on early-stage investing.

So sum it all up and approximately $1,425M in new early-stage life science capital is needing to be put to work and eventually returned at some hopeful market exceeding multiple to the fund's limited and managing partners. What are you doing to make your entity “investable”?

OnBioVC | July '09 Trend Analysis Available

Hot off the press! (and, better late than never…) The July 2009 OnBioVC | Trend Analysis study is now available for FREE via download [HERE]. Over $668M flowed into early-stage biopharma, diagnostic and device companies in the seventh month of 2009 and over $3,821M year-to-date! Find out who is investing in what and where.

Word on the street is that money is sitting on the sideline, not willing to be put to work in early-stage life science companies. A quick sort of the July data at OnBioVC.com shows that perhaps such a thesis is not on point; why in 31 days observed were 8 Series A financings raising $59.7M, or 1 in 5 deals were done as an entities first institutional round, throw in the B’s and we are talking 54% of July deals accounting for $326.4M.

A little trick for leveraging the data found at OnBioVC; say you are a pre-clinical oncology company looking to identify potential investors…simply go to the drop-down box on OnBioVC.com, select “X-Oncology”, observe the list of “Series A” financings then wa-la, you will find in each post all of the participating investors and hyperlinks to their sites. If you have any questions or problems on how to effectively mine the data at OnBioVC shoot me an email at arubenstein@rnaventures.com. Wishing you statistically significant data!

Allos THx | Significant Milestone Achieved!!!

Now, some 48-hours later, it may be considered old news that Allos Therapeutics (NASDAQ: ALTH) received from FDA accelerated approval for Folotyn™ (pralatrexate) for the treatment of patients with relapsed or refractory peripheral T-cell lymphoma (PTCL). Folotyn™ is the first and only drug approved by FDA for PTCL and represents a new treatment option for patients with relapsed or refractory PTCL. Allos anticipates entering the market with Folotyn™ in the US in October. The sound of champagne corks popping can be heard echoing up and down the Front Range as the Colorado life science ecosystem celebrates this significant and important milestone and simultaneously breaths a collective sigh of relief.

Let’s then take a bit of a closer look at Allos, their approved product, market and pipeline, shall we? (As always…if there is any erroneous data or statements identified and requiring correction please leave a comment below or email arubenstein@rnaventures.com and we will update with or without (your choice) attribution).

Hematological malignancies account for approximately 15% of all cancers and are categorized into four groups, 1. Multiple Myeloma, 2. Myelodysplastic Syndromes, 3. Leukemia – which includes acute myeloid, acute lymphoblastic, chronic myeloid, and chronic lymphocytic leukemia, and 4. Lymphoma – which is divided into Hodgkin’s and non-Hodgkin lymphoma. NHL is further grouped into:

• Cutaneous T-cell lymphoma
• Follicular lymphoma
• Mantle cell lymphoma
• Diffuse large B-cell lymphoma, and
• Peripheral T-cell lymphoma
  

According to the American Cancer Society, non-Hodgkin lymphoma incidence has grown 3.8% from 2005 to 2009. The US PTCL market is growing at an estimated incidence rate of 5% due, in part, to increased PTCL awareness; the addressable market is approximately 80-90% of estimated first-line patients treated (according to Allos), or more specifically of ~6,800 patients forecasted in 2013, ~6,200 are treatable. It has been reported that single agent treatments prescribed off label for PTCL average approximately $76,000 per patient per therapeutic and therefore one may calc the total addressable market at ~$516M to $471M per year – NOTE: this is not a market forecast for Folotyn™.

Allos maintains exclusive worldwide commercial rights to Folotyn™ for all indications and their exists the potential for co-promotion or out-licensing to reach EX-US markets. The composition of matter patent protection is in place till 2017 in the US and EU with the potential for an additional 5-year extension under Hatch-Waxman. Additional potential hematological malignancy indications for Folotyn™ that are under clinical investigation include B-cell non-Hodgkin’s lymphoma, non-Hodgkin’s lymphoma and cutaneous T-cell lymphoma, and in solid tumor indications for bladder cancer and non-small cell lung cancer.

Folotyn™, a next generation chemotherapy, is a rationally designed, for improved cancer cell uptake and retention, anti-folate. The mechanism of action of Folotyn™ is a folate analog that inhibits folate metabolism by binding to and inhibiting the enzyme DHFR. Folotyn™ has high affinity for the RFC-1 protein and is an efficient substrate for polyglutamation by the enzyme FPGS. Polyglutamated Folotyn™ has a prolonged intracellular half-life, which allows for prolonged action in malignant cells. The relative increase in cellular uptake by RFC-1 and differences in polyglutamate formation may account for the enhanced activity of Folotyn™.


Some additional players in the hematological malignancy market include Biogen Idec (NASDAQ: BIIB) who markets with Roche (VTX: ROG.VX) Rituxan® for non-Hodgkin’s lymphoma; Novartis (NYSE: NVS) who markets Gleevec® for chronic myeloid leukemia, and; Wyeth (Pfizer) (NYSE: WYE) who markets Mylotarq® for acute myeloid leukemia.

It will be fascinating to observe Allos evolve from a development-stage company to a commercial-stage entity. Needless to say this is an incredible achievement – bringing a new treatment option to market for patients with relapsed or refractory PTCL.

FDA Allos pic courtesy of http://topnews.us

Tape-Delay from the RMLSIC | 3 of 4

Today’s third of four installments covering the Rocky Mountain Life Science Investor Conference focuses on the medical device presenting companies. In addition, here are some links to the additional coverage:

Part I – The Dx companies [HERE]
Part II – The Biopharma companies [HERE]
Part iV – Summary [In the Works]

BiOptix – Boulder, CO-based BO has developed a highly sensitive biosensor for real-time detection of trace amounts (~pg/mm^2) of bacteria, viruses, proteins, miRNA and other nucleic acids, and antibodies. The patented biosensor design relies upon common path interferometric detection in combination with non-resonant surface Plasmon excitation – the design of which was conceived by University Colorado 2005 Physics Nobel Prize Laureate and BO Chief Scientific Advisor John Hall.

Coherex – Salt Lake City, UT-based commercial-stage CH is focused on catheter-based technologies for the treatment of certain structural heart defects. The initial focus is on a minimally invasive device to treat a common defect called Patent Foramen Ovale (PFO). The FlatStent™ PFO Closure System includes an implantable, self-expanding Nitinol stent with a polymer substrate designed to stimulate tissue growth within the PFO. AN exclusive multi-year distribution agreement with Abott Laboratories (NYSE: ABT) was recently announced.

Kinetic Muscles – Tempe, AZ-based KM is a preclinical-stage medical tehnology company focusing on recovery for victims of stroke, traumatic brain injury and other neurological injury via the combination of robotic therapy technology and telemedicine to create a ‘virtual clinic’ that delivers therapy to the patients home. The company recently signed a supplier contract with Healthsouth (NYSE: HLS), the largest provider of rehabilitation services in the US.

Leap Frogg – Grand Junction, CO-based LF is a clinical-stage company developing the Frogg Dynamic Compression System, a venous augmentation system for the prevention of deep vein thrombosis prevention, pulmonary embolus prevention and edema therapy.

Medipacs – Tuscon, AZ-based MP is developing the Mini-Infuser™ a disposable infusion pump drug delivery system whose pumps utilize a polymer actuator that enables precise programmed delivery. The technology lowers manufacturing costs and enables the creation of small infusion devices that may be worn by patients.

Medivance – Louisville, CO-based MV is a commercial-stage company focused on the Actic Sun™ product, a therapeutic temperature management designed to improve patient outcomes through precise control of core body temperature after traumatic events such as cardiac arrest, traumatic brain injury and hemorrhagic stroke.

Micro-Imaging Solutions – Greenwood Village, CO-based MIS has developed a technology enabling miniaturization of CMOS disposable micro-digital cameras that are low cost, high resolution and enable extreme product design flexibility in a variety of medical device applications that do or may not have previously incorporated imaging.

Numira Biosciences – Salt Lake City, UT-based NB is a specialty Contract Research Organization focusing on Virtual Histology™, a new technology for soft tissue nas skeletal imaging combining proprietary contrast agents and software with microCT imaging; and, high performance visual analytics via the graphic processing unit for accelerated image processing and analysis techniques.

Regenesis Biomedical – Scottsdale, AZ-based RB is a commercial-stage company marketing the Provant Therapy System® which delivers Cell Proliferation Induction® therapy into post-operative skin tissues to reduce pain and edema in the inflammatory phase of wound healing via triggering mitosis and gene expression of various growth factors, extracellular matrix proteins and enzymes involved in tissue repair and regenerations.

ThermImage – Salt Lake City, UT-based TI is a preclinical-stage company developing Thermaflux Scan™ for the safe and noninvasive detection of pediatric Vesicoureteral Reflux, a common and under-diagnosed condition where urine flows back to the kidneys from the bladder, exposing them to infection.

Valve Xchange – Aurora, CO-based VX is a preclinical-stage company developing the Vitality™ Exchangeable Heart Valve for adult and pediatric/congenital heart valve disease – an permanently implanted docking station and exchangeable leaflet set, when needed, using minimally invasive techniques – offering a lifetimes tissue valve alternative to mainstream heart valve patients.

Vital Access – Salt Lake City, UT-based VA a developmental-stage company focused on Vital Access Venous Window™ a fully-interventional vessel anastomosis device enabling interventionalists to percutaneously create anastomoses (connecting two different vessels) without using sutures or the need for invasive surgery. The Venous Window™ may provide quicker, easier and more reliable cannulation access to hemodialysis patient’s fistula while also potentially improving fistula longevity and patient quality of life.

Snoasis Medical | Born to Smile!

Commercial-stage Snoasis Medical (Denver, CO) is focused on the development and commercialization of products which redefine the way clinicians perform perioplastic surgery. The core technology behind Snoasis Medical’s current product offering is placental tissue. These placental tissue products are believed to be the first of its kind for dental applications and possess features and benefits which may lead to improved satisfaction for the patient and the clinician. BioCover™, the initial Snoasis product to reach the market, represents possibly the first allograft composed of amnion tissue for use as a wound covering for the treatment of gingival recession.

This novel solution to gingival recession is a processed, dehydrated graft containing multiple layers of human amnion tissue. BioCover™ technology leverages the basement membrane architecture of oral mucosal tissue and the high concentration of the adhesion factor, laminin-5. The product does not require hydration prior to use – it rehydrates upon placement and naturally self-adheres to the exposed root surface and proximal bone, this unique attribute eliminates the need to suture the graft into place – and therefore BioCover™ may become the preferred procedure to the current standard-of-care where patient tissue is first harvested from the palate and then sutured in place.

Greg Gumbel, host of the business news program, The Economic Report takes his camera and staff on a journey exploring the large market of gingival recession, or receding gum lines, (>25% of US adults, Company data) and details how and why the BioCover™ solution brought to market by Snoasis Medical is positioned to potentially transform the use of amniotic tissue and the incorporation of regenerative medicine in the dentistry market. Watch the video below, or if reading this via email or RSS-reader click [HERE] to view. Finally read the coverage of Snoasis Medical in the July 2009 issue of Orthopedics This Week [HERE].

The Program You Are Watching is a Paid Advertisement for Snoasis Medical

Anthera | Working to Thaw the Markets

CLSDF continues to maintain keen watch on the thawing of the public equity markets, calibrated in a semi-quantitative approach via the life science IPO pricings. If all three of the current filings get out priced ‘as-is’ I would then call the score FINANCING EVENT 3 & LIQUIDITY OPPORTUNITY 2. A nice balance and it makes sense as the three clinical-stage pre-revenue companies (Cumberland, Omeros and Anthera) appear to intend to use the public offering as a capital source to finance the phase III to commercialization processes.

Anthera Pharmaceuticals is the newest name to be added to the CLSDF-IPO Watch List. Hayward, CA-based Anthera Pharmaceuticals is a privately-held company committed to developing and commercializing clinical pharmaceutical products that address unmet medical needs of patients with life-threatening, chronic and acute inflammatory diseases and autoimmune disorders. The Company has acquired from Eli Lilly (NYSE: LLY) and Shionogi & Co. worldwide rights (excluding Japan) to a series of clinical and pre-clinical compounds that inhibit the enzymatic activity of members of the phospholipase family - a group of enzymes responsible for the release of arachidonic acid and subsequent production of leukotrienes‚ prostacyclins and other mediators of inflammation. These highly potent compounds inhibit novel‚ upstream steps in the inflammation cascade and have the potential to address a variety of diseases.

Tape-Delay from the RMLSIC | Part Deux

Continuing here with Part Deux of the Rocky Mountain Life Science Investor Conference presenting companies. Yesterday CLSDF posted the Diagnostic oriented entities, today we feature the biopharma folks.

ApopLogic – Aurora, CO-based AL is a biopharmaceutical company focused on the discovery, and development of therapeutic products that target apoptotic cell death pathways found in cancers, leukemias and lymphomas. The lead compound is Breceptin, a novel anti-cancer technology that antagonizes neuropeptide growth-factor receptors, targeting a broad range of cancers. The pipeline also includes Fasaret a proprietary therapy based on Fas ligand, an apoptotic cell death-inducing molecule with unique pro- inflammatory properties and Cytonil a proprietary combination of a cell-type specific growth factor and a cell signaling agonist to treat Sezary leukemia, cutaneous T cell lymphoma and psoriasis.

Allogenesis – Denver, CO-based AG is focused on pHPM, a ‘humanized’ purification of blood extracts for expansion of stem cells used for research & clinical applicications as well as wound healing in the dermal, orthopedic and additional soft tissue applications. The pHPM product is engineered to replace animal proteins in stem cell culture applications and augment existing in vitro culture media.

BioAmps – Aurora, CO-based BA is focused on focused on the discovery and development of proprietary antimicrobial peptide therapeutic solutions for the treatment of systemic infectious diseases, including methicillin-resistant Staphylococcus aureus (MRSA) and other resistant gram-negative and gram-positive bacteria. A rational design platform has produced a large portfolio of D-confirmation, alpha-helical antimocrobial peptides that are structurally manipulated to alter their hydrophobicity and amphipathicity properties. The charge substitutions and structure alterations on both the polar and non-polar faces of the peptides produce a unique “carpeted model” mechanism of action, broad spectrum of activity, and low level of toxicity to human cells.

GlobeImmune – Louisville, CO-based GI develops active immunotherapies called Tarmogens® for the treatment of cancer and infectious diseases. Tarmogens are recombinant yeast engineered to express disease antigens. Lead products include GI4000 and GI5005 both in Phase II for cancer and hepatitis C. The Tarmogen™ manufacturing process is simple and scalable with small molecule-like margins.

Inviragen – Ft. Collins, CO-based IV is focused on vaccines against emerging worldwide infectious diseases. Compounds queued up for clinical trials includes DENVax against dengue, HFMDVax against hand, foot and mouth disease and JEVax for Japanese encephalitis. In addition, are a number of ongoing vaccine research programs in chikungunya, HPV, influenza and plague vaccines.

LigoCyte Pharmaceuticals – Bozeman, MT-based LCP is a clinical-stage biologic drug development company focused on respiratory and gastrointestinal indications. The company’s virus-like particle (VLP) vaccine technologies support products that induce robust immune responses to prevent serious infections. The lead product is Norovirus VLP Vax in Phase I and the pipeline includes the biodefense vaccines against influenza and anthrax and the monoclonal antibodies Anti-CD103 partnered with Biogen Idec (NASDAQ: BIIB) and Anti-CD62 partnered with NIH.

miRagen – Boulder, CO-based MR is developing innovative microRNA (miRNA) based therapeutics for cardiovascular and muscle disease. The lead optimization pre-clinical pipeline candidates are focused on heart failure with indications of post-MI remodeling, chronic heart failure and refractory angina; broader cardiovascular disease including cardiac fibrosis, angioplasty/restenosis and arrhythmia; and, general fibrosis, muscular atrophy and amyotrophic lateral sclerosis.

Myocept – Lafayette, CO-based MC is a pre-clinical stage biopharmaceutical company focused on biotherapeutics designed to modulate signal transduction through subtypes of the cholinergic receptor family (AChR). The receptors targeted control contraction of skeletal and smooth muscle fibers, while other members of the AChR family are involved in angiogenesis, pain, additiction, down-regulation of inflammatory immune responses and progression of certain cancers.

Western States Biopharma – Aurora, CO-based WSB is a pre-clinical stage biopharmaceutical company developing novel therapies that selectively modulate adaptive immunity to treat inflammatory diseases while concurrently affecting the immune system’s natural ability to fight disease. Potential lead indications under consideration for WSBI19711A include rheumatoid arthritis, psoriasis, psoriatic arthritis, ulcerative colitis, and anklyosing spondylitis.

FDA 2.0…Really?

Now this is interesting! The Food and Drug Administration's Center for Drug Evaluation and Research, in collaboration with FDA's Center for Biologics Evaluation and Research, Center for Veterinary Medicine, and Center for Devices and Radiological Health, has announced a public hearing (scheduled for 12 & 13 November in Washington DC) to discuss issues related to the promotion of FDA-regulated medical products (including prescription drugs for humans and animals, prescription biologics, and medical devices) using the Internet and social media tools (can you say Twitter, Facebook, YouTube and the blogosphere, etc.?). FDA is seeking participation in the public hearing and written comments from all interested parties, including, but not limited to, consumers, patients, caregivers, health care professionals, patient groups, Internet vendors, advertising agencies, and the regulated industry. This meeting and the written comments are intended to help guide FDA in making policy decisions on the promotion of human and animal prescription drugs and biologics and medical devices using the Internet and social media tools. FDA is seeking input on a number of specific questions but is interested in any other pertinent information participants in the hearing would like to share. From my understanding the last discourse FDA held on the matter was in October of 1996. For a blast from the (Web 1.0) past to a look at the transcript [HERE].

Tape-Delay from the RMLSIC | Part I

I had the best intentions of bringing up to the minute information flowing through CLSDF from the content rich Rocky Mountain Life Science Investor Conference however, during the first company presentation slot it quickly became apparent that due to the richness of the subject matter in order to keep up I had to turn off the laptop and turn on my brain. So with that said here is an overview recap of the presenting entities broken out by biopharma, device and diagnostic companies. So without further adieu here are the Dx entities who presented:

Applied Microarrays – In 2007 Tempe, AZ-based AM acquired the microarray assets of GE Healthcare (NYSE: GE); the core technology capabilities include design and production of DNA and protein microarrays, circulating tumor cell capture microarrays and, expertise in surface chemistries, capture probe design, precision piezoelectric printing, assay optimization and reagent formulation.

Axial Biotech – Salt Lake City, UT-based AB ScolioScore™ AIS prognostic test is the first molecular Dx DNA-based assay for spinal disorders. The prognostic is a clinically validated test with a 99% negative predictive value that determines the likelihood of severe spine curve progression for children diagnosed with Adolescent Idiopathic Scoliosis. The product is being marketed by DePuy Spine, a Johnson & Johnson (NYSE: JNJ) company.

Beacon Biotechnology – Aurora, CO-based BB BrightSPOT System™ point-of-care diagnostic microarray chip enables up to 100 simultaneous diagnostic assays to be performed simultaneously with a single blood or other fluid sample. The handheld reader instrument moves the laboratory to the bedside. Initial therapeutic foci is on infectious diseases and diabetes.

Biodesix – Broomfield, CO-based BD is a developer of Dx tests using their proprietary platform based upon mass spectrometry. The company is advancing the revolution in personalized medicine, providing physicians with clinical information that assists with the diagnosis of disease and selecting appropriate and effective therapeutic treatments. The first product, VeriStrat®, a simple blood test used by oncologists to assist in decision making while treating non-small cell lung cancer, was marketed in 2008.

Castle Biosciences – Friendswood, TX-based CB is a biomarker-based oncology multivariate molecular Dx company focusing on orphan cancers. Their first product, DecisionDx-GBM, was taken to market in 1Q09 and targets glioblastoma multiforme, the most common form of primary brain cancer. The DecisionDx-LEA product is currently in clinical development.

High Throughput Genomics – Tuscon, AZ-based HTG is a commercial stage diagnostic company offering the quantitative Nuclease Protection Assay (qNPA™) Gene Expression Platform, a multiplexed, lysis-only assay of mRNA and miRNA with no RNA extraction, no labeling and no amplification required.

LineaGen – Salt Lake City, UT-based LG is target validation stage specialty Dx company offering tests for Autism, Osteoporosis, COPD and Multiple Sclerosis that leverage its access to the biomarker discovery research platform provided by the Utah Genetic Research Project and the Utah Population Database.

nanoMR – Albuquerque, NM-based NMR is developing a Dx for the detection and identification of bacteria and fungi in blood, the primary cause of sepsis. The assay, promising results in as little as one hour uses immune-labeling to attach magnetic beads to the blood borne pathogens that are then detected via nuclear magnetic resonance imaging.

EJ BioMed in Bed with Stryker

EJ BioMed, a spin-off from Ft. Collins, CO-based Eldon James Corporation, who focuses on production of critical use components for medical devices, recently announced an exclusive supplier deal with Stryker (NYSE: SYK) to design and produce tubing and fittings for next-gen Stryker Medical hospital mattresses. The new 105-pod cushion matrix mattress was developed to prevent pressure ulcers by incorporating a unique technology to eliminate the need for repeatedly turning patients.

Live Blogging from the RMLSIC

UPDATE (Breakfast) - Roy Davis, VP Corporate Development at Johnson & Johnson (NYSE: JNJ) and President JNJ Development Corporation opened the first full day of the RMLIC. He focused on “Creating New Business Opportunities at Johnson & Johnson” and stressed how a targeted focus on fostering innovation outside the entity (in addition to internal development) is in place which may ultimately benefit JNJ. Highlighting current P&L and capital stresses faced by the earliest start-up to the behemoth large-cap big pharma and associated headwinds in the current economic climate have increased the challenge to manage business for the long term. Red Script Ventures was founded by JNJ Dev Corp in part to help address the challenges of making the leap from not the incremental technological progression but to larger replacement technological leaps. Historically JNJ would participate in investing at the B round or later. Today Red Scrip Ventures participates in early-stage equity investing and provides value-add business acceleration and incubation services via leveraging access to the significant resources available throughout the entire JNJ enterprise. One caveat, and an obviously understandable one, Red Script must be the only strategic investor participating in a particular deal. Off to the first round of presentations…I’ve selected the Dx track.

Laptop…check, wifi…check, Conference pass…check! CLSDF is primed to live blog the 2009 Rocky Mountain Life Science Investor Conference coming to you from the Ritz-Carlton Denver in the Mile High City. Check back throughout the day for updates, likewise I’ve embedded my twitter-feed below, as certain ‘tweets’ may be more timely and serve as a good backup if the wifi is disrupted (or follow along at http://twitter.com/arubenstein). Note that I will be updating the embedded picture album below throughout the day as well. If you are reading this post in an email or RSS feed be certain to visit http://CLSDF.com to observe the updates.

The Conference got off to a delightful start at the Governor’s Residence at Boettcher Mansion, well technically our group was directed to the on premises ‘Carriage House’, simply lovely nonetheless. A few opening remarks by CBSA President John Collar before hearing a brief history of the Colorado life science ecosystem from Morgenthaler Ventures Partner Chris Christoffersen. Then it was off to the Cotes du Rhone, delectable tapas and some serious elbow rubbing.

Next up i. breakfast speaker and ii. the first group of presenting companies. Stay tuned…

1 IPO! 2 IPO?? 3 IPO???

UPDATE: Lots can happen between an early morning blog post and the end of the business day. In this case Omeros has set its IPO terms; 6.82M common shares offered between $10 and $12 per share. So the company is hoping to raise between $68.2 and $81.8M. The planned ticker to trade under is NASDAQ: OMER. Bring on the opening bell!

First Fed Chairman Bernanke says that the worst recession since the Great Depression is seemingly behind us, then my home re-appraises for 30K higher than what was hoped and prayed for, and now…all sorts of activity in the life science IPO market. What is going on here? Have we hit bottom? A quick scan to my right of the early CNBC coverage and I see that the market is up +31 at the open, green, green, green everywhere I look. Really? Hmmm…well ever the optimist, I too am swinging from Bear to Bull and in fact would like to go out on a limb here and have CLSDF call Tuesday 16 September 2009 as the bottom.

The public life science markets have been en fuego the last few months; just take a look at the NASDAQ Biotech Index (below) and similarly the 2Q09 OnBioVC Trend Analysis [HERE] shows similar positive investment growth in the private life science companies.

Last month Nashville, TN-based Cumberland Pharmaceuticals (NASDAQ: CPIX) went public raising $85M @ $17 per share and was essentially the first IPO in about two years sans the Bristol-Meyers Squibb (NASDAQ: BMY) spin-off of the Mead Johnson Nutrition (NYSE: MJN) unit. Since its debut Cumberland has more or less maintained its strength and avoided a major sell-off, at last check it is trading at $15.40. And just last week Cumberland launched their fever and pain drug Caldolor®, an injectable form of ibuprofen intended for patients who are hospitalized and cannot take oral drugs.

Now with Cumberland a public entity and certainly enjoying the time, effort and expense of remaining a public going-concern here comes the flood of filings behind them. Well OK, perhaps just a trickle, but the trickle may be the preface to the flood.

Filing paperwork with the Securities and Exchange Commission is the Seattle-based biotech Omeros, a clinical-stage company whose most advanced product candidate is OMS103HP, designed to improve postoperative joint function and reduce pain following arthroscopic anterior cruciate ligament reconstruction surgery. Currently in Phase III an NDA filing is expected to be submitted to FDA in 2H10. The planned offering would be underwritten by Deutsche Bank Securities, Wedbush Pacific Growth Life Sciences, Leerink Swann, and Needham & Company, according to the filing.

Similarly Research Triangle Park, NC-based Talecris has also filed paperwork with the SEC regulatory agency. With more than 4,500 employees and annual revenues north of $1.4B a Talecris IPO is certain to dwarf what happened with Cumberland and Omeros, if they can get out, being a pre-revenue entity. It would not be surprising to see upwards of $1B raised on this offering. Talecris is marketing Gaumnex® for immune therapy deficiencies, Prolastin® for alpha1-antitrypsin deficiency and Koate-DVI® for hemophilia.

Clearly there is a buzz of activity transpiring in the space. Where will you be positioned when the flood gates open?

Checking in with Juvaris Biotherapeutics

Recall that Steven Dow, DVM, Ph.D., Professor in the departments of Clinical Sciences and Pathology in the College of Veterinary Medicine at Colorado State University, co-founded Juvaris Biotherapeutics.

Good or bad, Juvaris is now a Burlingame, CA-based biotechnology company, developing adjuvanted vaccines for infectious diseases. Recently a definitive agreement with Antigen Discovery, Inc. was announced providing Juvaris access to ADi's proprietary high-throughput protein microarray screening system to discover novel disease-specific antigens. Juvaris will sponsor research for multiple disease targets and pay ADi upfront payments, development milestones and royalties on licensed products in exchange for full product development rights to all fields except diagnostics, which will belong to ADi.

This deal comes on the heels of reporting results demonstrating that their universal influenza vaccine produces robust antibody responses and complete protection in H1N1 and H3N2 pre-clinical challenge models. Juvaris’ universal influenza vaccine has demonstrated significant induction of immunity with a novel construct of M2e, which is a conserved sequence found on all influenza A strains. The Juvaris universal flu vaccine is composed of conserved antigenic epitopes for both influenza A and B strains combined with its proprietary adjuvant, JVRS-100. The objective of the universal influenza vaccine is to improve the reliability and quality of protection by raising cross-protective immunity to all strains of influenza.

In clinic the JVRS-100 vax appears promising as well… In a Phase I study, 128 young adult subjects in groups of 20-24 were vaccinated with a licensed trivalent influenza vaccine with or without JVRS-100. Subjects receiving JVRS-100 adjuvanted vaccine were shown to have antibody responses to influenza A that were approximately two-fold higher than recipients of unadjuvanted vaccine. The adjuvant was well tolerated, and the incidence of adverse events following vaccination with JVRS-100 at effective dose levels was similar to that in the vaccine-alone groups.

The future appears encouraging for Juvaris, with a deal with Bayer Animal Health on the books and a diverse opportunity in seasonal, pandemic and universal influenzas, and herpes simplex virus-2, look for the company to close a new round of funding soon, possibly led by Kleiner Perkins again, to be reported at OnBioVC.

The Term Sheet | ‘Don’t Miss’ Seminars

There are a couple of upcoming seminars that are architected to yield some sophisticated insight on typically complex issues around financing early-stage life science companies. The first event courtesy of the Colorado Bioscience Association is Negotiating the Venture Term Sheet (25 September 9am, @ Cooley Godward – to RSVP or for more info click [HERE]). This will be a mock role-play term sheet negotiation providing perspective from both sides of the table as well as some tips on how to resolve impasses. The second event courtesy of the Society of Physician Entrepreneurs and Holland & Hart is Fundraising and Securities Law (14 October 7:30am, @ Bioscience Park Center – to RSVP or for more info contact Molly Edwards meedwards@hollandhart.com). This seminar is focused on understanding securities laws related to fundraising from an angel investor (not VC/PE/IB) perspective (qualified accredited investors).

Aggregated below are some insights on common terms within the term sheet provided courtesy of local Boulder VC Brad Feld. Though Brad is focused on IT investing naturally there is plenty ‘o relevant overlap on the life science entity term sheets. This content should provide you with a solid foundation and load you up with relevant questions to bring to the seminars.

Keep in mind however how asymmetric views may be brought forth by all of these resources. I would love to use Colorado Life Science Deal Flow to facilitate a deeper conversation focused on fundraising, including Angel/VC/PE/IB/etc. So if you have thoughts and/or experiences to share please leave a comment at the bottom of this post at http://CLSDF.com or email me and indicate whether or not you would like your comments published in follow-on posts.

Finally, you may wish to bookmark this particular post so that the following terms discussions are easily referenced.

Term Sheet | Price
Term Sheet | Liquidation Preference
Term Sheet | Board of Directors
Term Sheet | Protective Provisions
Term Sheet | Drag Along
Term Sheet | Anti-Dilution
Term Sheet | Pay to Play
Term Sheet | Dividends
Term Sheet | Redemption Rights
Term Sheet | Conversion
Term Sheet | Conditions Precedent to Financing
Term Sheet | Vesting
Term Sheet | Information and Registration Rights
Term Sheet | Right of First Refusal
Term Sheet | Voting Rights and Employee Pool
Term Sheet | Restriction on Sales and Proprietary Info
Term Sheet | Founders Activities
Term Sheet | Initial Public Offering Shares Purchase
Term Sheet | No Shop Agreement
Term Sheet | Indemnification and Assignment
Term Sheet | Compelled Sale Right

Tom Cech | On CNBC Squawk Box

Tom Cech recently appeared on the CNBC pre-market morning program Squawk Box to discuss a variety of topics including the future of biomedical research, the Colorado Initiative in Molecular Biotechnology and the 1989 Nobel Laureate’s return to the University of Colorado where he will also be resuming teaching freshman chemistry.

It is always fascinating to listen to Dr. Cech but what made this particular interview so special was the combination of not only who was answering the questions but who was asking the questions, that was CNBC Squawk Box anchor and University of Colorado, Molecular, Cellular and Developmental Biology graduate Joe Kernen. After Joe graduated CU MCDB he went on to graduate school at the Massachusetts Institute of Technology where his work focused on erythroleukemia cells, and led to publications in CELL, Developmental Biology, and Cold Spring Harbor Symposia on Quantitative Biology, and then focused his career on Wall St.

The eight minute interview is embedded below. If you are reading this post via an email or RSS subscription please click [HERE] to watch the video at http://CLSDF.com.

SharesPost | Private Company Transactions

In the spirit of cool…I stumbled upon SharesPost – a sort of CraigsList meets ebay for buyers and sellers of private company equity. Talk about creating a new marketplace. Naturally there is a lot of legalese required to complete such a transaction, from investor qualification to transact, to escrow and indemnification agreements and beyond. Now I’m no attorney, nor do I play one in the blogosphere but it does appear, to my naive eye, that SharesPost does yeomen’s work to address all of the requisite issues in and around private placements. In addition to the marketplace platform is some very robust company research that is often challenging to come by, particularly for privately held entities.

Though the SharesPost market is not surprisingly weighted towards technology companies there are some biotechs listed including a few molecular diagnostics companies, Navigenics and XDx, and Greystone Pharmaceuticals. You can see price-per-share offers on both the buy and sell side along with implied valuations for each offering, now that is cool. And the coolness does not stop there – research analyst opinions provide estimated target prices too. I would be a bit careful here however with these reports and valuations, though they do contain relationship disclosures there are often mountains of material facts that are not accessible.

But hey…if someday you may think, geez…I sure wish I could have bought some shares of Facebook or LinkedIn before they went public, well...now you can – and it will cost you $14.75 and $11.25 per share respectively.

All material contained herein is for informational purposes only and should not be construed as an offer or solicitation of an offer to buy or sell securities.

CIMB-Caruthers Groundbreaking | 9 Sept

Some of you may have had your head buried in a text book, an .xls file or bent over the lab bench with pipette in hand (or more likely...all three) and therefore have not heard about the Colorado Initiative in Molecular Biotechnology yet. CIMB’s mission is to foster new research, teaching, and technology development at the interface of life sciences, physical sciences, mathematics, computational sciences, and engineering. The focus of this initiative is to understand and manipulate living cells and control cellular behavior through a global analysis of molecular events using methods that span a continuum from basic to applied research. The area referred to as "molecular biotechnology" includes new methods in genomics, proteomics, molecular and cellular imaging, biophysics, mathematical analysis, materials engineering and chemical synthesis, which are leading the way towards fundamental changes in experimental sciences.

On Wednesday 9 September at 4:15pm Colorado Governor Bill Ritter, University of Colorado President Bruce Benson, Nobel Laureate and CU Distinguished Professor Tom Cech, CU-Boulder Chancellor Philip DiStefano and members from the entire CU-Boulder community will gather on the CU-Boulder East Campus to celebrate the groundbreaking of the Jennie Smoly Caruthers Biotechnology Building, the new home to CIMB. Come be a part of this wonderful celebration and Colorado life science milestone.

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Back-to-School BioBeers!

It’s Back-to-School & Back-to-Denver for BioBeers. We hope the summer was a fruitful time for you. Needless to say we are excited to kick-off ( yet) another exciting season of BioBeers, coming to you from live from high above the Mile High City – 27 floors high to be exact – at the swanky Peaks Lounge in the Hyatt Regency – Denver.

Equally as exciting will be the preface to BioBeers,that is the first annual Rocky Mountain Life Science Investor Conference! The Conference features investors from San Fran to Boston and presenting companies not only from here in Colorado (like…Beacon Biotechnology, Biodesix, BiOptix, GlobeImmune, MyoCept and ValveXchange, to name a few) but also from Arizona, New Mexico, Utah and Montana (like…Axial Biotech, Castle Biosciences, LigoCyte Pharmaceuticals, Medipacs, NanoMR and Numira Biosciences, to name a few).

We would also like to extend a warm welcome to all of our guests from out of town to come join us at BioBeers and unwind after what is certain to be an exciting, though long, day of presentations and partnering meetings. Peaks Lounge is a delightful 7 short block walk from the Ritz Carleton. Hope to see you there!

Be certain to follow BioBeers on Twitter | @BioBeers

When: September, 17th @ 6:30pm
Where: Peaks Lounge @ Hyatt Regency Denver, 27th Floor (650 15th St.)

Mark your calendars and please be certain to RSVP at http://BioBeers.com for the 17 September event.

BioBeers: Connecting Bio-Entrepreneurs Since 2007

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Venrock | Building Companies for 40 years

The history of Venture Capital dates back to 1946 courtesy of the American Research and Development Corp., founded by Georges Doriot, who is subsequently considered to be the father of VC. Though many may argue the following (myself included)…The birth of biotechnology can be pegged to the 1953 presentation of the DNA double-helix structure by Watson and Crick (and others). So then one may postulate that these two industries, VC & biotech, have more or less grown-up together. Talk about symbiosis…survival of each seemingly dependent upon the other (that is when considering life science specific venture funds).

One fund in particular has been masterfully catalyzing biotechnologies now for some forty-years…Venrock, who to date has invested approximately $2.4 billion in 437 companies since fund inception yielding and incredible 124 IPO's and 129 M&A exits. Simply an amazing track record! Some of these companies include Geron (Nasdaq: GERN), Gilead Sciences (Nasdaq: GILD), Idexx Labs (Nasdaq: IDXX), Ligand Pharma (Nasdaq: LGND), Millenium Pharma (Nasdaq: MLNM) and Sepracor (Nasdaq: SEPR) just to name a few.

In celebration of their rich (pun intended…) history and 40-year milestone Venrock has published Shaping the Future: 40 Years of Innovation. If you have an entrepreneurial streak in you set aside some time to enjoy the following focus on 40 start-ups (bio and non-bio) and the entrepreneurs that created them. (If you have trouble observing the slide presentation in your CLSDF email subscription take a look [HERE]).

Venrock: Shaping the Future, 40 Years of Innovation

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