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Friday, January 4, 2019

Ribon Therapeutics and Hans Bishop’s Sana Biotechnoloy Officially Launch


The new year brings new beginnings. In the biopharma industry, that means the launch of some new companies taking aim at potentially developing therapies or, even potential cures, for diseases. Two new companies have hit the ground running – Ribon Therapeutics and Sana Biotechnology.
Based in Lexington, Mass., Ribon Therapeutics launched this week with $65 million in a Series B funding round and a focus on developing first-in-class therapeutics targeting novel enzyme families activated under cellular stress conditions. The new company intends to use the proceeds from the financing round to advance its lead programs, including small molecule monoPARP inhibitors, into the clinic.

MonoPARPS are regulators of stress responses that can enable cancer cells to survive, as well as evade detection, Ribon said. Because of new science that has linked the activity of monoPARPS to disease development, the company has developed a technology platform that will harness monoPARPS for the therapeutics. Ribon’s initial focus will be to use this technology in the area of oncology, but the company said the idea is relevant in a number of disease indications, including inflammatory and neurodegenerative diseases. The focus of Ribon’s lead program is on advancing the science of PARP7 inhibitors for the treatment of cancer, beginning with squamous cell carcinoma of the lung.
Ribon will be helmed by Victoria Richon, who will serve as both president and chief executive officer. Prior to helming Ribon, Richon oversaw discovery and preclinical research in oncology at Sanofi. In a statement issued today, Richon said the company will apply its “expertise in drug discovery to develop novel and effective treatments for defined patient populations with limited therapeutic options.”
Financing for Ribon’s Series B was led by the Novartis Venture Fund, with participation from new investors JJDC and Celgene Corporation. It was also supported by The Column Group, Deerfield Management, U.S. Venture Partners, Osage University Partners, Takeda Ventures and Euclidean Capital.
On the other side of the country, Sana Biotechnology launched with a focus on creating and delivering engineered cells as medicines for patients. The Seattle-based company was co-founded by Hans Bishop, the former CEO of Juno Therapeutics. Bishop will serve as executive chairman of the company’s board of directors.
Sana was spun out of Flagship Pioneering and has been supported by investments from ARCH Venture Partners & F-Prime Capital.
In its announcement, Sana said recent advances in science have made it possible to “reprogram cells in the body or replace damaged cells and tissues,” which can create a new class of medicines to treat a broad array of diseases. Sana’s core capabilities are being built around several areas, including “making cells at scale ex vivo to replace any damaged or missing cells in the body; in vivo delivery to specific cell types of any payload – including DNA, RNA, and proteins to reprogram cells; and immunology expertise to hide allogeneic cells.”
Sana Therapeutics will be led by Steve Harr, who is also a co-founder. Harr said that cell and gene engineering provide an opportunity to address the underlying causes of disease and deliver benefits that have not before been possible.
“There are challenges in making and delivering these kinds of medicines to patients, but also the opportunity to treat illnesses that today have few if any, options. Our goal with Sana is to bring together the people, technologies, and resources needed to address these challenges, changing both how we approach treating disease and what we expect as outcomes for patients,” Harr said in a statement.
Bishop said the company launches with a “portfolio of potential medicines and technologies” from scientific innovators that include Flagship Pioneering, Harvard University, the University of California San Francisco and the University of Washington School of Medicine.

AngioDynamics Tops Q2 EPS by 5c, Revenues Beat; Offers FY19 Outlook


AngioDynamics (NASDAQ: ANGO) reported Q2 EPS of $0.22, $0.05 better than the analyst estimate of $0.17. Revenue for the quarter came in at $91.5 million versus the consensus estimate of $89.24 million.
  • Net sales of $91.5 million, an increase of 5.5% year over year
  • Gross margin expanded 440 basis points year over year to 53.7%
  • GAAP EPS of $0.06 per share; adjusted EPS of $0.22 per share
  • Cash provided by operations of $13.0 million; capital expenditures of $0.7 million
  • Announced the acquisition of RadiaDyne and its proprietary OARtrac® radiation dose monitoring platform to build the Company’s continuum of care within the oncology space
“We are very pleased with our second quarter financial results, which are marked by growth across all of our business segments, expanding gross margins, and improved profitability. Our quarterly performance was positively impacted by our recent acquisitions, validating our portfolio optimization strategy and enhancing our value proposition within oncology. In addition, we continue to make progress toward obtaining a pancreatic cancer indication for NanoKnife and recently received notification from the FDA that NanoKnife will be considered a Category B IDE once we receive approval to begin our DIRECTtm NanoKnife study for Stage III pancreatic cancer,” commented Jim Clemmer, President and Chief Executive Officer of AngioDynamics, Inc. “We are encouraged by these accomplishments and are well positioned to achieve our financial targets for the full year.”
GUIDANCE:
AngioDynamics sees FY2019 EPS of $0.82-$0.86, versus the consensus of $0.84. AngioDynamics sees FY2019 revenue of $354-359 million, versus the consensus of $356.09 million.

Mersana (MRSN) PT Lowered to $14 at Baird


Baird analyst Michael Ulz lowered the price target on Mersana (NASDAQ: MRSN) to $14.00 (from $20.00) while maintaining a Outperform

Poseida Therapeutics Prepares for IPO to Advance CAR-T Treatments


Poseida Therapeutics, which is testing CAR-T cell therapies for blood-borne and solid tumor cancers, has laid the groundwork for an initial public offering.
In documents filed with securities regulators Friday, the San Diego company set a preliminary IPO target of $115 million. The company has applied for a listing on the Nasdaq stock exchange under the symbol “PSTX.”
CAR-T therapies deploy T cells that have been engineered to kill cancer. These cells, programmed to act aggressively, have in some cases led to significant side effects, however. Results for the first two CAR-T products approved, both in 2017, have varied.
Poseida said its treatments are intended to address the challenges of early-generation CAR-T therapies, including duration, tolerability, and scalability.
The company said it plans to use the IPO proceeds to continue funding clinical development of its lead drug candidate, an CAR-T product for relapsed/refractory multiple myeloma, and to continue developing its preclinical drug candidates and research. It may also use some of the money to start a pilot manufacturing facility, which would cost as much as $15 million, Poseida said in the filing.
Poseida’s lead candidate, P-BCMA-101, is in Phase 1 testing. The investigational drug is targeting BCMA, a protein found on the surface of cancerous B cells in the bone marrow. The study is funded in part by the California Institute for Regenerative Medicine. Poseida said it plans to move the therapy into a Phase 2 trial by June.
It is also developing a CAR-T product candidate using cells from a healthy donor rather than the patient—a so-called autologous therapy. Poseida said it aims to make and store the candidate, P-BCMA-ALLO1, for future use. If all goes as planned, it will enter Phase 1 testing by early 2020, the company said.
Another autologous therapy Poseida is developing, P-PSMA-101, is being developed for patients with a form of prostate cancer that continues to spread even after a patient’s testosterone levels have been significantly reduced. The company said it plans to begin Phase 1 testing of P-PSMA-101 in the second half of this year. And P-MUC1C-101, another CAR-T that uses a patient’s own cells, is in late-stage preclinical development for multiple solid tumor cancers. That could enter clinical testing in 2020, the company said.
Even if Poseida meets its goal and raises $115 million in the IPO, eventually it will have to raise additional cash, according to the filing.
Poseida is headed by CEO Eric Ostertag. He founded Kentucky-based gene editing technology company Transposagen, which Poseida was spun out from in 2015. The company has since raised $74.8 million, borrowed $20 million, and received $15 million of a total $23.8 million awarded in grant funding from the California Institute of Regenerative Medicine, according to regulatory documents.
The company reported net losses of $19.7 million in 2017 and $31.5 million in the first nine months of 2018.

December saw the most new healthcare hires in decades


December brought the U.S. healthcare industry’s largest monthly spike in the number of new hires since at least February 1990.
Healthcare added 50,200 jobs last month, the largest numeric increase in new hires in Modern Healthcare’s monthly jobs data, which stretches back to February 1990. Hiring in the industry jumped 56% from November, according to the U.S. Bureau of Labor Statistics’ December jobs report released Friday. The last time healthcare hiring surpassed 40,000 in a single month was in October 2015, the data show.
While more than 50,000 new jobs was “an unexpectedly high number,” healthcare hiring has grown at higher rates in the recent past, said Ani Turner, co-director of sustainable health spending strategies with the consultancy Altarum. The healthcare jobs growth rate hit 2.2% in December, beating out the non-healthcare growth rate of 1.7%.
Turner said she expected healthcare hiring to level off at the end of the year rather than to increase further, especially given the fact that insurance coverage expansion has largely plateaued. It could be just the normal monthly fluctuation in jobs numbers.
“Sometimes the numbers do kind of bounce up and down,” Turner said.
Healthcare’s share of total jobs rose to an all-time high of 10.79% in December. That’s partly because healthcare continued to grow and add jobs during the Great Recession, even as the rest of the economy lost jobs and took a long time to regain them.
“It stays steady and continues to grow while everything else bottoms out,” Turner said.
Three-quarters of the new healthcare hires were in the ambulatory sector, adding 37,800 jobs in December, 97% more than in November. Within ambulatory, home health comprised the biggest increase, adding 13,300 jobs, up more than 230% from November. Dentists’ offices added 7,200 jobs, compared with just 300 in November. Physicians’ offices made 6,700 new hires, up 22% from November. Outpatient care centers added 3,100 jobs, down 47% from November.
It’s unclear why home health saw such a dramatic spike in December. Sometimes consumers who have met their insurance deductibles seek more care at the end of the year, but that doesn’t necessarily translate into more hiring, and especially not for home health providers, Turner said.
“I would not be at all surprised to see a very low number in home health next month,” she said. “Sometimes it just does fluctuate like that.”
December wasn’t a stellar month for hospitals, however, which added 7,400 jobs last month, down 42% from their November total of 12,700.
Residential mental health facilities added 2,900 jobs last month, an improvement from November, in which they lost 900 jobs. Nursing care facilities experienced a December lull in hiring, adding 700 jobs, down from 900 new hires in November. Community care facilities for the elderly added only 100 jobs.
Total nonfarm employment rose by 312,000 jobs in December, and the unemployment rate rose by 0.2 percentage points to 3.9% as more people looked for work.
Healthcare added more jobs than any other industry last month. It beat out professional and business services, which added 43,000 jobs, and food services and drinking places, which added 41,000.
Overall in 2018, healthcare added 346,000 jobs, more than the 284,000 jobs added in the industry in 2017.

Creating New and Better Habits for the New Year


Recently, Mike Bellafiore at SMB Capital has been emphasizing the idea of positive habit formation with his traders.  It’s a great focus for the new year:  developing the patterns of thought and behavior that help us achieve our goals.  Here’s an excellent video from James Clear, based on his new book,Atomic Habits.  An important point made by the video is that we can transform our experience of ourselves one small behavior at a time, as we internalize whatever it is that we do.  Of course, that can also work in reverse:  when we fall into bad habits, we can internalize the sense of being lazy, unproductive, undisciplined, etc.
Here’s an interesting video from Tony Robbins that connects changes in our behavior to changes in our emotional and physical states.  The implication is that we don’t have to repeat the common pattern of making new year’s resolutions, only to see them fall by the wayside.  We can use our emotional and physical states to trigger the right behaviors and we can change our behaviors to form new and powerful habit patterns.
In the book that I am currently writing, I describe how the great spiritual traditions of the world provide us with powerful tools for changing our states and accessing our strengths.  This has important implications for traders:  the great trades come from the soul, not the ego.  In developing ourselves spiritually, we can find greater success in the material world.  This is because we move beyond ego-based motivations and reactionsand more consistently access who we truly are.
In short, we will not transform our trading by staring at screens, hanging on each tick of profit or loss.  We will not transform our trading by pushing, pushing, pushing to get bigger, bigger, bigger in our trades.  Nor will we transform our trading by focusing on every move that we don’t monetize.
Spirituality, too, can become a habit.  Lots of good things can happen when our best practices and greatest strengths become our consistent processes.

California high court won’t review $91M fine against UnitedHealthcare


The California Supreme Court says it won’t review a lower court’s decision last year that set the stage for Minnetonka-based UnitedHealth Group paying a $91 millionfine to the state’s insurance commissioner.
In September, an appeals court ruled in favor of California regulators in their attempt to impose fines on a UnitedHealth subsidiary called PacifiCare related to more than 900,000 alleged violations of state law on insurance claims.
After the ruling, UnitedHealth said it would appeal the matter to the California Supreme Court, but the court late Thursday said it would not review the case.
“I am delighted the Supreme Court has rejected further challenges to the insurance commissioner’s authority to punish insurance companies for knowingly harming even one consumer,” said Dave Jones, the California Insurance Commissioner, in a statement on Friday.
UnitedHealth Group on Friday did not immediately provide a statement in response.
In 2005, UnitedHealth Group acquired PacifiCare for $9.2 billion in a deal that was one of the biggest health plan mergers at the time. Two years later, UnitedHealth Groupofficials acknowledged in an unusual public confession that the company had forced new technology and business practices too quickly in new markets such as California, resulting in “physician resentment, network disruptions and operational overload.”
UnitedHealth pledged to pay claims faster and repair relationships with doctors, and the California Medical Association told the Star Tribune in 2010 that PacifiCare seemed to have solved problems. The California Department of Insurance in 2008 filed an enforcement action against PacifiCare, alleging the insurer engaged in multiple unfair claims settlement practices and other violations of the insurance code. Following a hearing, the insurance commissioner found PacifiCare engaged in over 900,000 acts and practices in violation of the code.
“Customers have no choice but to rely on the integrity of their health insurance companies,” Jones said in a statement. “PacifiCare breached that trust.”