Allos: Encouraging Data = Next Round of Financing

On the heels of Allos Therapeutics (NASDAQ: ALTH) reporting of positive interim data for their pivotal Phase II PDX (pralatrexate) trial, where a 29% of 65 T-cell lymphoma patients had either a complete or partial response, have now unveiled their follow-on financing strategy for ongoing clinical requirements in addition to preclinical R&D of pipeline candidates, manufacture of clinical trial material, pre-commercial scale-up activities for PDX, working capital and general corporate purpose needs. That is the planned sale of 9.00M shares of newly issued common stock with up to an additional 1.35M shares available to cover over allotments. Banc of America and Citigroup are acting as co-lead underwriters on the financing which is expected to be declared effective early in June. Recall Allos last issued 9M shrs about a year and a half ago raising just north of $50M; if this new financing is priced similarly at $6/share one could expect the deal to bring in approximately $62M less expenses.

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When It Rains It Pours - Replidyne Served

Replidyne (NASDAQ: RDYN) has been served with a Demand for Arbitration from MEDA Manufacturing alleging that the Company breached its obligations under a 2005 supply agreement. In April 2007, Replidyne provided notice to MEDA of its termination of the Supply Agreement in accordance with certain termination provisions, and believes that it did not have any obligations to MEDA under the Supply Agreement beyond May 2007.

The Demand seeks damages for breach of contract in the amount of approximately $2.3M plus interest and reimbursement of attorney fees and other costs incurred in proceedings. In addition, the Demand requests a judgment that Replidyne's termination of the Agreement was ineffective and that there is an obligation to continue to make annual minimum payment amounts of approximately $3.6M to MEDA remain in effect. If termination of the Agreement is determined to be ineffective Replidyne may also remain obligated additional future fees of up to approximately $2.6M (total approximating $$9.5M). Replidyne plans to vigorously defend itself against the allegations made in the Demand

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Valuation in Life Sciences: A Practical Guide

Some people read the Old Testament, others may read the New Testament, the Koran, the Bhagavad Gita, or the Guru Granth Sahib, my bible has become…Valuation in Life Sciences: A Practical Guide by Dr. Boris Bogdan and Ralph Villiger. This work has emerged as my one unambiguous go-to text when it comes to evaluation and valuation needs.

Just when I thought the risk adjusted net present value (rNPV) was the model for biotech and pharma valuation work Dr.’s Bogdan and Villiger have opened my eyes (and spreadsheets) to the world of real option valuation (ROV). What is key and fundamental to ROV theory is the development of a project (or company or patent or license or M&A transaction or stock, etc.) is dependent upon the changing market conditions of the real world and the sensitivity to incorporate this dynamic nature into the modeling versus discounted cash flow approaches where the modeling is static and predefined and thus unaccommodating to the dynamic market fluctuations of the real world.

Anyone who has ever sat down to model out a valuation of biotech or pharma assets that are yet to reach market, either pre-NDA, in the clinic or even pre-IND well there are a basket of hurdles (to say the least) associated with achieving a meaningful analysis. Leveraging the tools provided in Valuation in Life Sciences provides a road map on just how to achieve meaningful and flexible analyses. If you are in start-up mode, tech transfer, business development, finance or even still in business school do yourself a favor and pick-up a copy, you will not be disappointed!

UPDATE:

The authors are holding a one-day workshop (6 June in San Francisco, at the Fairmont Hotel and 16 June in San Diego, at the Sheraton Hotel and Marina). Sounds like it will be an incredible day focused on:

• Structure valuation models in Excel
• Source input parameters (success rates, durations, costs)
• Structure license contracts to bridge differing assumptions between licensor and licensee
• Analyze and interpret license contracts for licensor and licensee in terms of: rNPV, IRR/ROI and Value share
  

For more information and registration information click (HERE) or follow this link: http://www.avance.ch/newsletter/Invitation/Workshop_June.pdf

I hope to attend the San Diego workshop, if you are planning to attend too shoot me an email (arubenstein@ranventures.com) and let’s connect.

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Alphasniffer is now BiOptix

It is not the first, will not be the last, name change that is. Alphasniffer (Boulder) has announced a new corporate identity, introducing…BiOptix. This modification in moniker echoes how the Colorado life science ecosystem is certainly maturing from a research and discovery engine to the logical progression of more of a commercialization focus, this second corporate name change announced in 2008 validates our regions evolution.

Corporate re-branding is not unique to the life sciences. I’ve listed a few name changes that you may or may not have been aware of. See how many of the list below you would have guessed correctly, the names on the left were the predecessors:

WAS Anderson Consulting IS Acenture
WAS Philip Morris IS Altria
WAS KPMG IS Bearing Point
WAS Backrub IS Google
WAS Computing Tabulating & Recording IS IBM
WAS Kentucky Fried Chicken IS KFC
WAS Jerry’s Guide to the WWW IS Yahoo
WAS United Telephone IS Sprint
WAS Tokyo Telecom IS Sony
WAS Brad’s Drink IS Pepsi
WAS Matsushita Electric IS Panasonic

BiOptix, established in 2003, is developing a proprietary technology for real-time, sensitive, label-free detection of medically and commercially important molecules such as DNA, proteins, toxins, contaminants and other compounds. Applications using this broad technology platform include real-time detection instruments for markets such as medical research, personalized medicine and diagnostics, pharmaceutical process control, defense and homeland security, and numerous other industrial demands. The core technology, known as SPR-CPI, was invented at BiOptix by Dr. John Hall, 2005 Physics Nobel Prize Laureate. Congratulations to Misha Plam, Slava Petropavlovskikh, Oyvind Nilsen and the entire team at BiOptix for achieving this maturation milestone!

A if for Agilent, B is for Boulder, C is for Nucleic Acid

Did you know that Agilent Technologies (NYSE: A) provides bio-analytical and electronic solutions to a variety of industries; the company's bio-analytical measurement business segment provides application-focused solutions that include instruments, software, consumables, and services that enable their customers to identify, quantify, and analyze physical and biological properties. Its product categories include gas chromatography, liquid chromatography, mass spectrometry, microfluidics, microarrays, atomic force microscopy, PCR instrumentation, software and informatics, and related bioreagents, as well as consumables and services.

A portion of that bioreagent business sits squarely in the middle of Boulder, as a result of the 2006 acquisition of SynPro, where the focus is on large-scale nucleic acid synthesis and purification for pharmaceutical ingredient manufacturing. Now the $5B a year Agilent plans to grow the Boulder nucleic acids unit as a result of another recent acquisition of the Dowpharma Nucleic Acid business unit. It is expected that up to thirty new hires will be made at the Boulder campus. Bring it!

Replidyne Provides 2008 Guidance

Yesterday Replidyne (NASDAQ: RDYN) held their annual shareholder meeting and 1Q08 conference call. With an anticipated burn rate of approximately $10M per quarter Replidyne’s current cash position just north of $78M positions operations to continue well into 2009. Considering the new strategic initiatives including restructuring, cash conservation and the difficult decision to terminate enrollment of the Phase III faropenem study management laid out the company plans to move forward with the C. difficile program with the goal of initiating a Phase I trial with REP 3123 as well as identifying an IND candidate from the DNA replication inhibition program. A spectrum of business development activity appears to be transpiring, though no details have been made public, some of which include: i) partnering talks are ongoing ii) looking at M&A opportunities, whereby the large cash position may make Replidyne more attractive to enable opportunistic actions and iii) a large international investment bank has been appointed to bring forth potential US and ROW opportunities, after all...the current market is frothy with deals. Needless to say with Replidyne’s seasoned and sophisticated management team it will not be surprising to see the share price and faropenem development pulled sharply out of their nose dives.

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BioBootCamp Day 1: Getting In Shape

It was buzz cuts and pushups, nuts and bolts, project management and IP protection, reimbursement and regulatory, & compliance and management teams all crammed into Day 1 of BioBootCamp, whoa, I am exhausted and we are only half-way through. Yes sir! Not only has the content been fantastic and the presenters polished, motivated and interactive but something interesting has happened this year on the recruit side…attendance has more than doubled from years past, and now the once vast double conference room, provided by the very gracious hosts at Holland and Hart, appears to be bursting at the seams, even with the no-shows (more laps for you when you arrive today). It was a wonderful feeling to look around the room and not recognize so many people. My take home after Day 1 is that there is even a higher interest/activity in entrepreneurial endeavors than anticipated. The room was bursting with MD’s, Ph.D.’s, MD/Ph.D.’s not to mention the MBA’s, industry folks, soon-to-be, first-time and serial-entrepreneurs…just an absolutely wonderful cross-section in attendance. Looking forward to Day 2…I had better start stretching.

Where Does Pharmion Go From Here?

In a recent interview with the Star-Ledger, New Jersey-based Celgene (NASDAQ: CELG) Chief Executive Officer Sol J. Barer, Ph.D. provided some insight as to the integration plans for Pharmion products and intellectual capital. Following is a portion of that Q&A.

Q: Celgene already was expanding its presence abroad. What does adding Pharmion do for you internationally?

A: We have a sales force all over Europe right now. We have a very good infrastructure that's very leveragable. We're selling Revlimid, and doing very well right now. With the Pharmion integration, we're adding thalidomide, which is approved in first-line multiple myeloma (in Europe). Revlimid is approved in relapsed or previously treated multiple myeloma. We also have a marketing approval for Vidaza, the first therapy that will show a survivability advantage in patients. Rather than partner, what we do is retain the value for our shareholders by building our own infrastructure - clinical, regulatory - around the world. We'll use distributorships in certain countries or certain regions.

Q: What happens to Pharmion's operations? Will you keep any presence in Colorado?

A: We're going through the integration planning process. We're looking at as many positions and many levels and all the products. We're very impressed with with a lot of people there, at all levels. As you combine two commercial, public entities, you don't need two CFOs, you don't need two CEOs -- thank god. There's clearly going to be overall consolidation. What we're going to try to do is retain as many of the people that are motivated and excited to stay with Celgene.

Q: A year ago, you said you might be looking for bigger quarters around Summit because the company was growing and you disliked satellite offices. What are your plans now?

A: We'll have multiple sites. (Pharmion) has a major clinical site in Kansas City, which we'll keep. We'll probably be adding a building or buildings here on-site. We've gotta live with the fact that there'll be multiple locations with the major company we're becoming. I'm pleased to say the sun never sets on Celgene, to borrow a phrase. It's difficult. We're used to addressing the company all at once, and now that can't happen. If it's 7 o'clock in the morning here, it's 9 at night in Japan but 4 in the morning in California. So when we try to have meetings, we try to move them around.

Q: Even before Pharmion, Celgene seemed to be stepping up its licensing and partnership deals. Will that continue?

A: A lot of these are driven by specific opportunities that often are difficult to predict. There will be a period of time subsequent to the Pharmion acquisition where a lot of integration will go on. While that will not affect the smaller deals, it probably will affect the larger collaborations, which would be a lower priority while we're integrating the new company.

Q: How has your job changed in the past year?

A: One of the big challenges is really, as we grow, to maintain the entrepreneurial spirit, the almost family atmosphere that's characterized Celgene through the years. I think that's been important to our success. I view that as one of my greater challenges.

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GW Carver Award to Gevo CEO

Perhaps not on many peoples radars…yet…Gevo (Denver) a next generation bio fuels company recently moved to town from Pasadena and Cal Tech, from where their intellectual property originates. Backed by Khosla Ventures and Sir Richard Branon’s Virgin Green Fund Gevo incorporates three novel technological elements enabling the scalable production of biofuels.

Recently during the World Congress on Industrial Biotechnology and Bioprocessing, BIO presented the first annual George Washington Carver Award to Gevo CEO Pat Gruber, Ph.D., MBA in recognition of his accomplishments in creating and commercializing a new plastic made from annually renewable resources.

Prior to joining Gevo, Dr. Gruber was the President and CEO of Outlast Technologies and held several management positions at Cargill. He has also served as President and CEO of Lactech, a technology development company, and was one of the founders of NatureWorks where he was the VP of Technology and Operations and Chief Technology Officer from 1997 until 2005. Dr. Gruber has served as a member of the Federal Advisory Committee for Biomass R&D and the Advisory Committee for the Energy Future Coalition and currently serves on the board of directors of Outlast Technologies, Gevo, Segetis, and Green Harvest Technologies.

Congratulations to Dr. Gruber and the entire team at Gevo and WELCOME TO COLORADO! We are thrilled you have made your new home here!

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BIO2008 + Twitter = Follow Me @arubenstein

Though still over a month away I am gearing up for BI0 2008 and yes blogging is part of the plan however, I will be posting ‘tweets’ via Twitter documenting my live experiences throughout the entire conference, as opposed to regular blog posts that I will get to at the end of the days. Twitter is a micro-blog; it allows for very short posts yet is extremely quick & easy to use. If interested, take a look at this video (if reading this post in email or RSS feed you will have to cruise on over to http://CLSDF.com to view it) for a quick explanation of Twitter. If so moved go and set up an account at http://twitter.com be sure to follow me @arubenstein and send a tweet if you wish for me to follow you back. As BIO approaches I will talk more about how to make accessing Twitter even simpler and easier than the web browser offering. Stay tuned...


Twitter in Plain English from leelefever on Vimeo.

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Array BioPharma: Secures $80M Debt Facility

With over $116M in cash on the books as-of 31 March that did not keep management at Array BioPharma (NASDAQ: ARRY) from securing an additional $80M debt facility from Deerfield Management. Deerfield currently holds in excess of 4.7M shares of Array or nearly 10% of the company. This new debt round will be drawn down in two $40M tranches in June and December of 2008.

Needless to say how costly it is to commercialize a drug, depending on the source a common number used today is $800M and about ten years to reach the market. Now think about that cost for a single agent, small molecule, biologic etc. relative to the incredibly robust pipeline at Array where there are currently six compounds in the clinic for oncology and inflammation, and add to that the work ongoing in the discovery program…$116M simply may not provide enough dry-powder to get a single candidate to the finish line, but at this point financing events are rather often about achieving value-inflection based milestones, like demonstrating proof-of-concept, an IND filing or moving a compound into or advancing in the clinic, and not getting to market.

So how does management raise the requisite financings to achieve such milestones while protecting existing shareholders from dilutive effects? The answer is...debt, and CEO Robert Conway & Company are doing outstanding work not only stewarding the clinical and pre-clinical stage assets at Array but concurrently deploying a carefully architected fiduciary approach to the financing needs.

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Attention Thirsty Denver BioBeers Attendees!

You may (or may not) know that the May edition of BioBeers will be held in Boulder. At the moment BioBeers, Inc. is in the process of securing BioBus transportation from Denver to Boulder and back. Please take a few minutes to indicate on the side-bar survey (left column on BioBeers.com if you are reading this in email or RSS reader) if you would i) be interested in the BioBeersBoulderBioBus and ii) if you would be willing to cough-up a few bucks for the round trip.

Kindly respond with your interest/preferences by Friday 9 May. Thank you.

More details (date/time/place) of May Boulder BioBeers to follow…

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It’s Starting to Look a lot Like BIO…

The pre-event planning material for the BIO 2008 conference is pouring in fast and furious. (Do you plan to attend? Would you like to meet? Please contact me to arrange arubenstein@rnaventures.com). So whilst perusing the Product Focus Zone publication I was incredibly excited to see BaroFold (Boulder) highlighted in the Protein Therapeutics chapter. Jeff Cleland, Ph.D., VP of Therapeutic Development will be presenting BaroFold at this year’s BIO and was heavily quoted throughout the chapter highlighting the protein therapeutics market and in particular the proprietary PreEMT protein refolding technology that incorporates the use of high hydrostatic pressure to force water between protein molecules causing the dissociation of aggregates and thereby forcing the protein into its most compact form. Traditional aggregate removal techniques as part of the manufacturing process include chaotropic agents like guanidine hydrocholoride or urea to solubilize hydrophobic proteins which must then be removed. The PreEMT technology reduces the complexity of the manufacturing process and improves the quality of the protein therapeutic by increasing yield, homogeneity, stability and reducing production cost.

In other recent BaroFold news Mr. Jon Saxe, JD, LLM has joined the Board of Directors. Most recently Mr. Saxe was President of PDL Biopharma (NASDAQ: PDLI), then Protein Design Labs.

Finally, BaroFeron, a proprietary recombinant human interferon beta being developed for the treatment of Multiple Sclerosis, is expected to enter Phase I trials in 2H08. BaroFeron may be differentiated from other interferon-beta products by improved safety and greater bioavailability enabled by BaroFold's proprietary PreEMTTM technology.

It is exciting to see Colorado already shinning on the global BIO stage. Plenty more to come on BIO…

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Off to Phase IV for Letairis® and the Market for Volibris®

Among the core assets that Gilead (Nasdaq: GILD) acquired from Myogen in 2006 for $2.5B was Letairis® (ambrisentan), for the treatment of pulmonary arterial hypertension (PAH), which was then approved by the FDA in mid 2007. After about a quarter in the market Gilead has initiated a Phase IV, randomized, double-blind, placebo-controlled study evaluating Letairis® in patients with PAH who have failed to demonstrate an optimal response to sildenafil monotherapy (Viagra® is not just for ED ya know…). The primary endpoint of this study, known as Athena-1, is the change from baseline in pulmonary vascular resistance (the resistance to blood flow caused by constricted lung blood vessels) following 24 weeks of treatment. The long-term safety and efficacy measures will be examined for up to one year. There are additional planned follow-on Phase IV studies through 2009.

Folks around town may recall that GlaxoSmithKline (NYSE: GSK) owns the rights to commercialize ambrisentan for PAH in territories outside of the US. Recently GSK announced that the European Commission issued a marketing authorization for ambrisentan, under the trade name Volibris®, for the treatment of PAH in patients to improve exercise capacity, and the European product launch is now scheduled for 3Q08. Very exciting global news that can trace its roots back to Colorado! Naturally we will be closely tracking performance of Letairis® and Volibris® in the coming months and years

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BioBootCamp 2008: Drop and Give Me 50!

It is one week to go till BioBootCamp 2008 begins…are you ready to get your life-science start-up or start-up ideas in shape? Have you applied to attend? BioBootCamp is more than a 2-day business seminar, it is designed to help you jump start your new life science idea or company, this experience will provide you with not only a comprehensive overview of how to get your venture started, but will provide you exposure to experienced bioentrepreneurs and a nationally acclaimed faculty. By attending the BioBootCamp, you will learn how to avoid the legal pitfalls of starting and building a life science business, and will receive the assistance you may need to plan a solid foundation for your new business venture.

If you are interested in joining the growing numbers of Colorado life scientists eager to commercialize their ideas, click (here) for details on how to apply for this unique event (or copy/paste this link http://www.biobootcamp.com/apply.htm). This is a complimentary conference and there is no fee to apply or attend.

When: Thursday 8 May 7:30am – 5:00pm and Friday 9 May 7:30am – 2:00pm
Where: Holland & Hart 555 17th St. Suite 3200 Denver

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Insmed: Meeting Milestones!

Insmed (Nasdaq: INSM) provided a status update on their development program.

• After recently receiving approval form the UK Medicines and Healthcare Regulatory Agency to initiate a clinical trial for INS-19 [a follow-on biologic of Amgen’s (Nasdaq: AMGN) Neupogen®] patient screening has begun and the first dosing is expected next month with similarity data to be reported in June.

• INS-20 [a follow-on biologic of Amgen’s (Nasdaq: AMGN) Neulasta®], Insmed’s second follow-on biologic candidate completed pre- clinical pharmacological and pharmacokinetic studies, and plans to initiate clinical studies 4Q08.

• A Phase II study of IPLEX™, a complex of recombinant human insulin-like growth factor-I and its binding protein IGFBP-3, in Myotonic Muscular Dystrophy has been initiated and received IRB approval and is actively recruiting patients with enrollment north of 50% remains on target to complete enrollment in 1H08 with interim data analysis expected

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Bard Center Needs Your Help!

Two MBA students at the University of Colorado, Bard Center for Entrepreneurship are examining how their institution may better support the Colorado life science ecosystem via the delivery of specifically tailored graduate degrees, certificates and continuing education offerings that may ultimately empower, improve and expand the local workforce.

Kindly set aside five minutes of your time to complete their survey (HERE) or copy and paste this link in your browser: http://www.surveymonkey.com/s.aspx?sm=095p4OMPQQCjTWJJ_2ba3oTg_3d_3d.

The survey is confidential though you may add your email address at the end to request the final results. Your opinions are important! Thank you for time.

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Help Wanted: CU Technology Transfer Office

The Technology Transfer Office at the University of Colorado is seeking an entry-level Life Sciences Licensing Associate for its office at the Anschutz Medical Campus. The License Associate identifies, solicits, and evaluates invention disclosures for patent and market potential, and marketing technologies to commercial partners and tracks and develops a portfolio of associated intellectual property. The License Associate will also ensure all assigned new invention disclosures are properly evaluated for ownership, patentability, and commercial viability; reasonably exercising professional, independent judgment in the selection and use of techniques, methods, and timing of decisions to complete all assigned responsibilities.

For a full job description, including minimum and preferred qualifications, please visit the Jobs at CU site (here).

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Evolutionary Genomics: Series A Undisclosed

Evolutionary Genomics (Lafayette) an agricultural technology company who addresses the critical need to increase the availability of biofuel feedstocks has closed an undisclosed Series A financing with Denver-based Altira Group; not to be confused with the Altria Group or its much better known previous name Philip Morris (NYSE: MO).

EG’s Adapted Traits Platform is used to screen gene adaptations in biofuel feedstocks such as corn, switchgrass, sugar cane, algae and soybeans to improve yield-related traits, such as grains per plant, grain weight, yield per acre, biomass, drought resistance and disease resistance.

Altria Group focuses their fund thesis on the traditional and renewable energy sectors. The commitment to EG came from their $176M Fund V. Investments from this fund have typically been made in the $5-$10M range with follow-on investments as warranted.

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SBIR/STTR Bill Passes in House

Lest you think the Colorado Bioscience Association merely flexes its muscle in Colorado…think again. Denise Brown and Company weighed in with significant support on Capital Hill re: HR5819 or the SBIR/STTR Reauthorization Act, which passed in the U.S. House of Representatives by a vote of 369 to 43.

All Colorado Representatives (Diana DeGette, Mark Udall, John Salazar, Marilyn Musgrave, Doug Lamborn and Ed Perlmutter) sans Tom Tancredo voted for the bill. Next stop is the US Senate.

HR5819 modifies the eligibility rules affecting venture capital backed (biotech) companies. The bill will increase access to critical, early-stage sources of funding for small businesses, including small biotechnology firms, thereby facilitating economic growth, job creation, and most importantly new breakthrough therapies for patients in need. Venture Capital and SBIR dollars may now work in a complementary manner to bring new therapies and innovations to the marketplace, ultimately to benefit patients and consumers. Potential great news for Colorado and the entire industry! We'll certainly pay close attention to the bill's progress.

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