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Monday, May 6, 2019

Regulus up on improved finances

Thinly traded nano cap Regulus Therapeutics (RGLS +11.9%) is up on below-average volume on the heels of recent financing developments.
It will sell stock and warrants totaling ~$41.8M in a two-tranche private placement with institutional investors. The initial tranche, valued at ~$16.7M, consists of ~9.7M common shares and accompanying warrants at a combined price of $1.205. Certain investors have also agreed to 416K share of non-voting Class A-1 convertible preferred stock, each convertible into 10 common shares, at $10.80 per share along with five-year warrants to buy up to ~4.16M common shares at $1.08 per share at $0.125 per warrant. The transaction should close no later than May 7.
The second tranche of ~$25.1M of convertible preferred stock and accompanying warrants will be contingent on the restart of a Phase 1 study of RGLS4326 in autosomal-dominant polycystic kidney disease.
It has restructured its $14.7M term loan with Oxford Finance providing for a new 12-month period of interest-only payments and a new maturity date of May 2022.

FDA Grants Breakthrough Device Designation to Natera’s Signatera Test

Natera, Inc. NTRA, -2.27%today announced that the U.S. Food and Drug Administration (FDA) has granted “Breakthrough Device” designation for its Signatera™ test for use in the post-surgical detection and quantification of circulating tumor DNA (ctDNA) in the blood of patients previously diagnosed with certain types of cancer and in combination with certain drugs. The designation will help accelerate FDA assessment and review of Signatera as an in vitro diagnostic for use in pharmaceutical trials.
Signatera is the first ctDNA test custom-built for each patient based on the unique mutations in an individual patient’s tumor. Signatera has been shown in numerous clinical studies, across non-small cell lung, bladder, breast and colorectal cancers, to identify molecular residual disease significantly earlier (up to two years earlier) than standard imaging. [1-5 ] Studies have also shown that Signatera test status is the most significant predictor of long-term patient outcomes after surgery and treatment, relative to all other clinical and pathological factors. [1-5]

Sunscreen Chemicals Enter Bloodstream at Potentially Unsafe Levels: Study

For years, you’ve been urged to slather on sunscreen before venturing outdoors. But new U.S. Food and Drug Administration data reveals chemicals in sunscreens are absorbed into the human body at levels high enough to raise concerns about potentially toxic effects.
Bloodstream levels of four sunscreen chemicals increased dramatically after test subjects applied spray, lotion and cream for four days as directed on the label, according to the report.
The levels far exceed the FDA-set threshold which require topical medications to undergo safety studies, said Dr. Kanade Shinkai, a dermatologist with the University of California, San Francisco School of Medicine.
“It’s not like they went a little bit over,” she said. “It’s really quite high, orders of magnitude higher than that.”
However, experts are quick to say you shouldn’t stop using sunscreen because of this study. At this point, the known risk of harm from the sun’s rays exceeds the potential risk posed by these chemicals.
“I am concerned that people are going to stop wearing sunscreen,” Shinkai said. “We know ultraviolet light from the sun has very deleterious effects on the skin. It causes photoaging. It causes sunburn. And, as such, it causes melanoma and [other] skin cancer.”
Dr. Michele Green, a dermatologist with Lenox Hill Hospital in New York City, agreed.
“I think it’s confusing,” Green said. “While it’s more than the FDA recommends for their toxicology, we really don’t know what that means in terms of human health. I would not want people to stop using sunscreen based on this one study.”
Possible effects on hormones
The sunscreen study was led by the FDA’s Dr. David Strauss, and appears May 6 in the prestigious Journal of the American Medical Association, one of the nation’s leading medical journals.
Most sunscreens on the shelf use chemicals such as oxybenzone, avobenzone and octocrylene to block harmful rays. These organic chemicals absorb ultraviolet radiation and convert it into a small amount of heat.
However, animal studies have raised concerns that the chemicals, oxybenzone in particular, might disrupt normal hormone patterns in people, the FDA researchers noted in their study.
“These molecules are chemical rings, essentially, and they absorb light,” said Shinkai, who co-wrote an editorial accompanying the study. “Chemical rings are also the fundamental basis for a lot of hormones, and chemical rings tend to enter cells.”
Oxybenzone has been found in human breast milk, amniotic fluid, urine and blood, the FDA researchers said.
For its study, the FDA randomly had 24 adults apply either a sunscreen spray, lotion or cream four times a day for four days. The participants applied the sunscreen to three-quarters of their body surface.
The study took place in a lab, and the agency drew 30 blood samples from each participant over a week to see whether the chemicals in the sunscreen got absorbed through the skin.
Levels of oxybenzone, avobenzone, octocrylene and ecamsule increased in the bloodstream after sunscreen use, researchers found.
“There is definitely reason for concern, because if you think about it, any medication you buy over the counter, you would expect that everything in there has been tested, it’s safe, it’s effective,” Shinkai said. ‘This has never been proven for sunscreen.”
More real-life data needed
But it was a very small-scale laboratory study that simply shows the need for more research, said Dr. Raman Madan, a dermatologist with Northwell Health’s Huntington Hospital in Huntington, N.Y.
“While this is a starting point, the relevance of this result is unknown,” Madan said. “There needs to be further studies done to show what this really means. While it could have real-world consequences, it could very well mean nothing.”
The study also differs from real life in that people applied the sunscreen while hanging about a lab, Shinkai said.
“They weren’t doing the things people typically do when they use sunscreen,” such as swimming or working in the yard, Shinkai said. Because of this, their exposure might differ from that of everyday people.
The Consumer Healthcare Products Association (CHPA), a group representing sunscreen makers, also said it’s far too soon for consumers to have doubts about these products.
“Sunscreen manufacturers, FDA, and dermatologists are aligned on the goal of protecting the public from the harmful effects of the sun,” the group said in a statement. “Sunscreens save lives.”
CHPA said the FDA is committed to learning more about the safety of chemicals within sunscreens, however, and the new data “is consistent with these efforts.”
Options are out there
The FDA has been tussling with sunscreen manufacturers over studies to test the safety of their products, said Shinkai.
The agency has set a November 2019 deadline for manufacturers to provide safety data on their sunscreens, including evaluations of systemic absorption, the risk of cancer from the chemicals, and their effect on reproductive health, Shinkai said in her editorial.
The publication of this study might be intended to put pressure on the sunscreen industry to meet the deadline, she said.
“The FDA is a regulatory agency. It’s not a testing agency. For them to perform a research study is highly unusual,” Shinkai said. “I think that’s an important thing that suggests how concerned they were about this issue, and maybe perhaps the frustration on their part.”
People who are concerned about the safety of chemical sunscreens can opt to use mineral sunscreens, Shinkai said.
Those sunscreens rely on zinc oxide and titanium dioxide to reflect sunlight from the skin, rather than absorbing it like chemical sunscreens.
“These we know are safe,” Shinkai said of mineral sunscreens. “This is something that is evidence-based.”
More information
Harvard Medical School has more about sun protection.
SOURCES: Kanade Shinkai, M.D., Ph.D., dermatologist, University of California, San Francisco School of Medicine; Michele Green, M.D., dermatologist, Lenox Hill Hospital, New York City; Raman Madan, M.D., dermatologist, Northwell Health’s Huntington Hospital, Huntington, N.Y.; Consumer Healthcare Products Association, statement, May 6, 2019; Journal of the American Medical Association, May 6, 2019

Athenex (ATNX) Announces $100 Million Private Placement of Common Stock

Athenex, Inc. (Nasdaq: ATNX), a global biopharmaceutical company dedicated to the discovery, development and commercialization of novel therapies for the treatment of cancer and related conditions, today announced that it has directly entered into an agreement for the sale of its common stock in a private placement with three institutional investors, namely Perceptive Advisors, Avoro Capital Advisors (formerly known as venBio Select Advisor) and OrbiMed. The transaction is expected to result in gross proceeds to Athenex of approximately $100 million, before deducting offering expenses. Net proceeds from the transaction are expected to be used to fund clinical development and regulatory activities of Oraxol (oral paclitaxel and encequidar (also known as HM30181A)); clinical regulatory activities of KX2-391 ointment for the treatment of actinic keratosis; commercialization activities, including pre-launch activities for Oraxol; manufacturing infrastructure; and working capital and general corporate purposes.
The Company will issue 10 million shares of common stock for a purchase price of $10.00 per share, for aggregate gross proceeds of $100 million. The closing of the private placement is expected to occur on or about May 7, 2019, subject to customary closing conditions.
“We are extremely delighted by the support from these leading healthcare investment firms,” said Dr. Johnson Lau, Chairman and Chief Executive Officer of Athenex. “We believe the financing from this private placement will position us well to further advance our Phase 3 clinical programs for Oraxol and KX2-391 ointment and support our pre-launch and commercialization efforts.”

Cytokinetics’ reldesemtiv appears active despite trial miss, says Piper Jaffray

While Cytokinetics’ Phase III data for reldesemtiv missed the primary endpoint of slow vital capacity at 12 weeks, the drug did show benefits over placebo in amyotrophic lateral sclerosis, Piper Jaffray analyst Edward Tenthoff tells investors in a research note. He points out the company intends to advance reldesemtiv into a Phase III ALS trial. The analyst reiterates an Overweight rating on Cytokinetics and boosted his price target for the shares to $14 from $13.

Ovid up on OV101 data in rare inherited disorders

Ovid Therapeutics (NASDAQ:OVID) is up 16% premarket on robust volume on the heels of two presentations at the American Academy of Neurology Annual Meeting in Philadelphia on lead candidate OV101.
The first highlighted data from the Phase 2 STARS study in adolescents and adults with Angelman syndrome, an inherited condition affecting the central nervous system. A Phase 3 study in children with Angelman, NEPTUNE, should launch in H2.
The second pertained to the approaches to assess outcomes in Fragile X syndrome as a precursor to data the company expects to announce in H2 from the ROCKET trial.
OV101 (gaboxadol) is a delta (δ)-selective GABAA receptor agonist designed to specifically target the disruption of tonic inhibition, a central physiological process of the brain that is believed to be the cause of certain neurodevelopmental disorders.

Abbott renews smartphone-based cardiac monitor with more accurate detection

Abbott has launched a new, smarter version of its small implantable monitor for detecting irregular heartbeats, that the company says now reduces the rate of false positives by 97%.
About the size of a paperclip, the Confirm Rx insertable cardiac monitor connects directly to a smartphone app via Bluetooth, to offer continuous remote detection of arrhythmias without the need for additional transmitter hardware.
The loop recording device, which has been cleared by the FDA and received a CE mark, is placed just under the skin above the heart during an outpatient procedure. Additionally, Abbott’s mobile app is available in nearly 40 languages.
Abbott first picked up the Confirm Rx monitor and its smartphone app through its $25 billion acquisition of St. Jude Medical in January 2017. The device made its international commercial debuts later that year, including in Europe and the U.S.
The tracker is aimed at the estimated 33 million people living with the most common irregular heartbeat, atrial fibrillation, with many going undiagnosed.
It’s also designed for people with active lifestyles, and offers 24/7 monitoring compared to devices that need to be removed and placed in a charging station, which can lead to gaps in the detection of sporadic and infrequent arrhythmias.