“Start-up companies are focused on advancing their research,” said Opus Biotech cofounder Dan Eramian, “but unless they can compellingly articulate the value of their unique stories to investors early on, they risk leaving their technology in the lab.”
Eramian and cofounder Charles Craig have a combined four decades experience in public relations, investor relations, government affairs and reputation building.
“Start-up companies live in a highly competitive environment,” said Craig. “They must prove now not only that their science works, but also convince a price sensitive health care system to adopt it.”
Eramian served as the first vice president of communications for the Biotechnology Industry Organization (BIO) during the industry’s transformation from fascinating science to global health care innovator. He has managed challenging communications and investor relations at public and private biotech companies and served on their management boards. Eramian was also chief spokesman for two national federal agencies, the Department of Justice and the Small Business Administration.
Craig has been on the front lines of the biotech revolution as president of Georgia Bio and as a writer, editor and communicator for the Biotechnology Industry Organization (BIO), BioWorld Today and annual Ernst & Young Global Biotechnology Report. During his 30-year career, he also worked as a writer and editor for mainstream newspapers, magazines, and television news.
For more information on Opus Biotech Communications visit www.opusbiotech.com and contact Dan Eramian at 425-306-8716 email@example.com; and Charles Craig at 404-245-0591 or firstname.lastname@example.org.
“Over the last four years, axial has curated the country’s most comprehensive database of evidence-based best practices for pain treatment,” said Nancy Brown, Venture Partner at Oak HC/FT. “The rate of opioid misuse, abuse or overdose underscores the need for a smarter, information-driven approach to pain treatment that payers, providers and patients can use. axialHealthcare has pioneered evidence-based pain management solutions and is leading the way in addressing barriers to safe and effective pain treatment. I am excited to join their Board of Directors to continue to solve these issues.”
John Donahue, chairman and CEO of axialHealthcare, said, “We are excited to welcome Oak HC/FT into the axial family and look forward to leveraging their extensive healthcare expertise. Oak HC/FT’s funding comes as we build out our operational and clinical teams, continue to innovate and enhance our capabilities, and move to operationalize on our substantial pipeline of clients. We look forward to continuing our mission to mitigate opioid misuse and improve the care and well-being for patients in chronic pain.”
Pain treatment is a $330 billion annual spend category for payers and has escalated into an epidemic as opioid use has increased 400 percent in the last 10 years. In response to this situation, axialHealthcare was founded in 2012 to identify and address the drivers of poor clinical outcomes and escalating costs of pain management. The company has since assembled the nation’s largest data repository of patient pain claims and outcomes, as well as created the only evidence-based criteria for pain clinics.
axialHealthcare’s suite of pain management capabilities includes: predictive analytics; a decision-support platform that delivers pain population analytics, provider dashboard and content, network performance monitoring, and PharmD consultation for providers; and the nation’s only mobile patient app for patients experiencing chronic pain. axialHealthcare’s team of physicians, pharmacists, scientists, technologists and healthcare operators are uniquely positioned to ensure that patients in pain are provided with personalized, evidence-based care from informed practitioners. The company began deploying its pain care offerings with industry-leading client partners last year.
Under the terms of the offering, the Company will sell approximately 17.3 million shares of its common stock at a purchase price of $0.81 per share, which was the consolidated closing bid price of the Company’s common stock on October 11, 2016.
The Company intends to use the net proceeds from the offering to fund clinical development and other research and development activities and for working capital and general corporate purposes.
The shares of common stock described above are being offered directly by GTx without an underwriter or placement agent pursuant to an effective shelf registration statement previously filed with the Securities and Exchange Commission. Such shares of common stock are being offered only by means of a prospectus, including a prospectus supplement, forming a part of the effective registration statement.
This press release shall not constitute an offer to sell or a solicitation of an offer to buy any securities described herein. There shall not be any offer, solicitation of an offer to buy or sale of securities in any state or jurisdiction in which an offering, solicitation, or sale would be unlawful prior to registration or qualification under the securities laws of any such state or jurisdiction.
GTx, Inc., headquartered in Memphis, Tenn., is a biopharmaceutical company dedicated to the discovery, development and commercialization of small molecules for the treatment of cancer, including treatments for breast and prostate cancer, and other serious medical conditions.
Women Building Bio: The XX Factor, held on September 29 at the Inova Center for Personalized Health, brought together 250 leaders from enterprise life science companies and research institutions to entrepreneurs, legislators and academias. This event marked the first time women across the industry have come together from across Virginia and the BioHealth Capital region to identify needs and opportunities, make connections and continue driving excellence in bioscience.
“We are thrilled with the outcome of our first Women Building Bio conference,” said Crystal Icenhour, CEO of Aperiomics and chairman for Virginia Bio. “Women from across the region and in the industry are proving that we are leading the way on creating stronger, healthier communities due to the advancement of biosciences.”
Attendees of Women Building Bio participated in a variety of thought-provoking sessions and panels delivered by industry leaders including Todd Stottlemyer, CEO of Inova Center for Personalized Health; Rachel King, CEO GlycoMimetics; Barbara Newhouse, president and CEO of The ALS Association; Rep. Barbara Comstock; Amy Caro, sector vice president and general manager, Health Division, Northrop Grumman Information Systems; and Mindy Goldsborough, chief science and technology Officer of American Type Culture Collection.
“Women Building Bio was a success because of the extraordinary talent and resources we have in Virginia, Maryland and D.C.,” said Jeffrey Gallagher, CEO of Virginia Bio. “To see over 250 attendees embrace collaboration and innovation, regardless of their differences, to continue building the most important industry of our time, was truly inspiring.”
Virginia Bio plans on continuing highlighting the themes of innovation, celebration and collaboration at its upcoming events across the state, including at the statewide conference THRIVE 2017, on April 6 at the Hilton Virginia Beach Oceanfront.
About the Virginia Biotechnology Association
Virginia Bio is the premier statewide non-profit trade association for life sciences, promoting the considerable scientific and economic impact of the life sciences industry in the Commonwealth of Virginia. Virginia Bio is an advocate for innovation and entrepreneurship, and for the biopharmaceutical, and other health technology industries among federal, state and local policy-makers. Virginia Bio is the official state affiliate of the Biotechnology Industry Organization (BIO), AdvaMed and the Medical Device Manufacturers Association (MDMA) and also collaborates closely with the Pharmaceutical Research and Manufacturers of America (PhRMA). To learn more, visit www.vabio.org or Follow Virginia Bio on Twitter at @VABio.
THANK YOU TO OUR SPONSORS
Women Building Bio: The XX Factor was made possible by Inova, George Mason University, Darden Executive Education, Greenberg Traurig, PhRMA, Virginia Economic Development Partnership, Squire Patton Boggs, Pfizer, Xenith, Prince William County, HHMI Janelia Research Campus, Cherry Bekaert, Merck, George Washington University, AstraZeneca/MedImmune, Silverline Communications, Loudoun Virginia Economic Development, Northrop Grumman, Illumina, New England Lab, Embody, Avison Young, Virginia Biotechnology Research Park, Euclid, Polymer Solutions and James Madison University.
“We are pleased with this vote of confidence from the Transition Therapeutics shareholders as it underscores their confidence in our ability to leverage the potential of Transition Therapeutics’ clinical programs and the opportunity for shareholders of Transition Therapeutics to participate in the continued growth and development of OPKO’s strong pipeline,” said Phillip Frost, M.D., CEO and Chairman of OPKO Health. “This acquisition provides OPKO with two late stage drug candidates, each of which holds exceptional market potential and complements OPKO’s development pipeline.”
About Transition Therapeutics
Transition Therapeutics is a biopharmaceutical development company advancing novel therapeutics for CNS, metabolic diseases and androgen deficiency indications. The company’s wholly-owned subsidiary, Transition Therapeutics Ireland Limited, has two development programs: CNS drug candidate ELND005 for the treatment of Alzheimer’s disease and Down syndrome; and selective androgen receptor modulator drug candidate TT701. Transition’s lead metabolic drug candidate is TT401 for the treatment of type 2 diabetes and accompanying obesity. For additional information about the Company, please visit www.transitiontherapeutics.com.
Durham, NC-based Novan set a preliminary target of $60 million for the IPO, a figure that may change as the company works through how many shares it will sell and at what price. In its prospectus filed with securities regulators on Wednesday, Novan says proceeds from the stock offering would fund its lead drug, a topical gel for acne known as SB204, all the way through an application for FDA approval, and help push four other compounds in its pipeline forward, as well. The company has applied for a Nasdaq listing under the stock symbol “NOVN.”
The IPO filing comes eight months after Novan raised more than $30 million for late-stage clinical trials. SB204 is in two Phase 3 clinical trials for acne that should produce data in early 2017. If all goes well in those trials and Novan completes a planned long-term safety study, the company could apply for FDA approval by the end of next year. Data from mid stage trials of another drug, SB206, a gel being studied as a treatment for the warts caused by human papillomavirus (HPV), are expected later this year.
The dermatology market was $28 billion in 2014, Novan says, citing IMS Health data. But Novan says innovation in dermatology has been stagnant and some treatments for skin conditions, such as antibiotics, raise concerns about contributing to drug resistance. Novan believes its drugs can provide an alternative to such acne treatments.
Novan says it has figured out a way to administer nitric oxide, a volatile compound that is normally a gas, in a solid form. The compound has been researched in applications such as treating microbial diseases and managing inflammation. Right now, the only FDA-approved use of nitric oxide is the treatment of newborns who have pulmonary hypertension, or high blood pressure in the arteries to their lungs. Nitric oxide is administered from a gas tank in this setting, which makes it difficult to use as a treatment for other types of diseases.
By storing nitric oxide in a solid form, Novan says its “nitric oxide on demand” technology, called Nitricil, can be used to form new drugs that make delivery of the compound stable, targeted, and safe. Novan says it has a library of more than 200 Nitricil compositions, each with a unique way of releasing nitric oxide. The company says it focused on dermatology because its technology can work with the body’s own nitric oxide producing capabilities; each of the skin’s three layers release can produce and release nitric oxide at different rates.
“Our platform allows us the ability to tune the release profile of nitric oxide and trigger its wide range of beneficial effects when host systems fail or are overwhelmed by invading microorganisms,” the company says in its filing.
Nitricil was originally developed in the laboratory of Mark Schoenfisch, a chemistry professor at the University of North Carolina at Chapel Hill. Schoenfisch co-founded Novan in 2008 with Nathan Stasko, who was one of his graduate students. Stasko is now the president and CEO of the company, which has an exclusive license from UNC to develop and commercialize the nitric oxide technology.
Novan has spent more than $64 million on R&D since its inception, according to the filing, and has taken an unusual financing path for a biotech. Rather than rely on venture capitalists for funding, the company’s first outside investment came from Neal Hunter, the co-founder and former CEO of Durham LED technologies company Cree (NASDAQ: CREE). Novan’s work has since been funded primarily by
wealthy individuals, many of them introduced to the company by Hunter, who became chairman of Novan’s board of directors. Speaking at UNC’s Kenan Flagler Business School in April 2015, Hunter said that the company’s first $40 million was raised from angel investors in North Carolina’s Research Triangle. “What does that say about the Triangle? [There is] a lot more money around here than we think,” he said.
Novan brought on its first institutional investment in March 2015, when it raised $50 million led by Malin (ISEQ: MLC), an Ireland-based life sciences investment company. Hunterstepped down from the board in February after the closing of Novan’s most recent financing, which topped $32 million. A securities filing shows that 172 investors participated in that December 2015 round, suggesting that the company stuck with its strategy of raising money from individuals rather than institutions. Malin is Novan’s largest shareholder, with a 16.25 percent stake, according to the prospectus. Hunter owns 13.83 percent of the company.
Novan didn’t start out as a dermatology company. It initially aimed to use its technology as an antimicrobial coating for medical devices, which Stasko told me in 2009 would be the fastest way to market. Medical devices featuring Novan’s nitric oxide technology may yet reach the market, but under a different company. In its filing, Novan disclosed that late last year it formed a separate, privately held company called KNOW Bio and gave it Novan’s non-dermatological assets, intellectual property valued at $1.8 million. Novan also provided the new company with $5.2 million in working capital.
Any new investors in Novan won’t have a stake in any non-skin products that emerge from the new company. But Novan does have the right of first negotiation to license from Know Bio any dermatology-related technology the new company develops within three years of the separation agreement.
Novan’s filing comes as biotech IPOs haven’t been quite as easy to pull off as they were during the boom from 2013 through 2015, according to Glen Giovannetti, global biotechnology leader at Ernst & Young. Speaking in Durham Wednesday at an event to launch the firm’s annual Beyond Borders report on the life sciences industry, Giovannetti said the IPO window is not shut, but companies that successfully go public are doing so with significant insider participation in the stock offering. “Deals can still get done but it’s a much more challenging environment,” Giovannetti said.
Examples of recent biotech stock offerings that required inside help include the $70 million IPO of Watertown, MA-based Selecta Biosciences (NASDAQ: SELB) and Syros Pharmaceuticals (NASDAQ: SYRS), a Cambridge, MA-based biotech that raised $50 million in its IPO.
Novan does not yet have any FDA-approved products. The company has previously received revenue from government contracts, including a National Institutes of Health grant to study Nitricil for antimicrobial catheter coatings, as well as a Department of Defense contract to research the technology as a potential topical wound treatment for the military.
As of June 30, Novan had $19.6 million in cash. Even if Novan raises $60 million in its IPO, it will need more money to bring its products to market. Novan spent $22.3 million on R&D in the first half of 2016, more than double its R&D costs for the same period last year. Besides the acne and HPV drugs, Novan is also studying drug candidates for fungal infections of the skin and nails, psoriasis, and eczema.
Fabior (tazarotene) Foam, 0.1% is a patent-protected topical product indicated for the treatment of acne, the largest dermatology indication in the US affecting up to 50 million Americans every year1. Sorilux (calcipotriene) Foam, 0.005% is a patent-protected topical product indicated for mild to moderate plaque psoriasis affecting up to 6 million Americans each year1.
Both Fabior and Sorilux will be marketed through Mayne Pharma’s Specialty Brands Division and existing sales team. Re-launch for both products is expected in FY17. During the intervening period GSK will continue to distribute Fabior and Sorilux under a transition services arrangement.
The non-US dermatology assets will continue to be distributed by GSK in the short term and Mayne Pharma will seek to out-license these products to new partners.
Rationale for the acquisition
Mayne Pharma’s CEO, Mr Scott Richards said “This acquisition will strengthen Mayne Pharma’s position in the US dermatology market, diversify future branded earnings and create new opportunities for growth. Both Fabior and Sorilux are a strategic fit with the existing Doryx franchise and participate in attractive and growing markets. We believe both products are differentiated assets with compelling clinical data that physicians and patients will appreciate.”
“Mayne Pharma is very attracted to the underlying fundamentals of the US dermatology market. The acquisition will leverage existing commercial infrastructure across functions including sales and marketing, customer service, compliance, medical affairs and contracts administration. We also expect to leverage the new foam capability in future branded and generic product development programs.”
Mayne Pharma expects the products to contribute modest incremental EBITDA in FY17 and have significant potential for growth in future years.
“The addition of ON Light Sciences’ innovative technology allows us to better meet the needs of aesthetic practices that focus on energy-based devices,” said Philip Burchard, CEO of Merz Pharma Group. “We have a vision to be the most innovative company in aesthetics, and this acquisition clearly complements our growing and diversified global portfolio, which includes the Ultherapy® and Cellfina™ devices.”
The DeScribe® Transparent PFD Patch is placed over tattoos prior to irradiation, allowing physicians to treat tattoos more efficiently by enabling rapid multiple laser passes in a single treatment session. It also provides significant optical clearing of tissue, protects the epidermis and inhibits potentially infectious back-splatter and fumes. In a recent clinical trial1, laser tattoo removal patients reported not only less discomfort, but faster healing post-treatment with the DeScribe® Transparent PFD Patch.
“Merz North America’s robust aesthetic portfolio continues to strategically grow through innovative products addressing conditions with fast growing demand such as tattoo removal. This latest addition to our offerings underscores the strong commitment we have to growing our US business by responding quickly to market demands,” Merz North America President and CEO Bill Humphries said.
Tattoo removal is one of the fastest-growing laser procedures (109,641 performed in 2014), up 74 percent since 2012, as reported by the American Society of Dermatologic Surgery (ASDS), and new developments in medical device technology are encouraging more individuals to consider tattoo removal procedures more seriously.
Market research indicates that an increase in tattoo prevalence is correlated with rising levels of “tattoo regret.” According to a July 2015 study conducted by laser manufacturer Syneron-Candela, 33% of tattoo wearers in the US have at least one tattoo they would consider removing or would definitely like to have removed.
“We look forward to joining Merz and expanding awareness and use of the DeScribe Transparent PFD Patch. We share Merz’s commitment to innovation that directly and positively impacts patient health and welcome the opportunity to be part of its strong product line-up.” David Sell, President and CEO of ON Light Sciences said.
“Merz continues to actively seek opportunities to partner with or acquire companies such as ON Light Sciences,” said Hans-Jörg Bergler, Head of Corporate Development for Merz Pharma Group. “Through a focused corporate development strategy and our Merz Corporate Venture Capital Initiative, we remain actively engaged in funding innovative and category-building technologies within the aesthetics space.”
Current OLS customers should continue to place product orders via the ON Light Sciences’ website at www.onlightsciences.com.
The South Carolina Biotechnology Industry Organization (SCBIO) will work with the South Carolina Department of Commerce on a strategic plan that includes attracting more life sciences sectors to the state, says Wayne Roper, president of SCBIO, which was formed in 2004 and became a self-sustaining membership-driven trade association six years ago.
“We have the expertise and the interest in developing the job,” Roper says. “We know how to get the most bang for our buck in economic development.”
The partnership will begin with an inventory of life sciences companies and assets in the state, including on-site visits to pharmaceutical, medical device, research, diagnostic and medical equipment companies and their suppliers.
Next, SCBIO and state officials will identify opportunities to attract more human life-sector companies to the state, and then they’ll support the commercialization of research for South Carolina universities, Roper says.
The state is developing expertise in biopharmaceutical manufacturing, which is a burgeoning field, created by small companies, he says.
This type of manufacturing fills a huge need as some predict that half of all prescriptions will be biopharmaceuticals within the next four years, Roper says. “We’re talking about drugs for rheumatoid arthritis, cancer, diabetes, for autoimmune diseases; these are the treatments.”
South Carolina is well positioned to attract life science industries that fit within existing companies and infrastructure, without competing with Boston or North Carolina’s Research Triangle Park, Roper says.
Ultimately, the initiative could result in more high-paying jobs and the development of more business relationships and supply chains.
“We’re going to find companies that fit with South Carolina’s economy and ability to support and grow,” he says. “The field is vast.”