Tandem Diabetes down 6% on despite positive insulin pump data

Tandem Diabetes Care (TNDM -6.3%) slumps on almost 40% higher volume following its announcement of results from two studies of its t:slim X2 insulin pump with software called Control-IQ which automatically adjusts insulin delivery based on continuous glucose measurements (closed loop mode). The data were presented at the American Diabetes Association Scientific Sessions in San Francisco.

The company says both trials achieved the primary objective of increasing time in range (blood sugar is within the normal range) without any severe hypoglycemic events.

Results from the NIH-funded DCPL3 study showed that type 1 diabetics who used the device for six months experienced blood sugar levels in the normal range 71% of the time each day, superior to 59% for those using a sensor-augmented pump (control) (p<0.0001). Time spent above the upper limit of the normal range (180 mg/dL) was 27% in the X2/Control-IQ group versus 39% for control. Time spent below the lower limit of normal (70 mg/dL) was 1.4% for X2-Control-IQ compared to 1.9% for control. Investors appear to be have been expecting greater separation from the sensor-augmented pump.

Results from the Freelife Kid AP study in prepubertal children showed a 72% daily time-in-range rate (83% overnight). The time that blood sugar levels were above upper limit of normal dropped to 25% from 36% and time that levels were below the lower limit of normal decreased to 3% from 4%.

The times that the device operated in the active closed-loop mode in the two studies were 92% and 97%, respectively.

Shares may also be under pressure from the news about Provention Bio’s teplizumab for the interception of type 1 diabetes (T1D). Data from a mid-stage study showed a four-year delay in the onset of T1D in patients receiving a single 14-day regimen of the anti-CD3 antibody.

https://seekingalpha.com/news/3470144-tandem-diabetes-6-percent-despite-positive-insulin-pump-data

Atreca sets IPO terms

Atreca (BCEL) has filed a preliminary prospectus for an IPO of 7.35M Class A common shares at $16 – 18, valuing the offering at ~$125M at the midpoint.

https://seekingalpha.com/news/3470155-atreca-sets-ipo-terms

Deciphera expands cancer pipeline

– DCC-3116 Selectively Targets ULK Kinase, an Initiating Protein that Activates Autophagy –

– Company to Host a Webcast on Tuesday, June 18, 2019 at 8 a.m. ET to Discuss Autophagy Inhibition and the Treatment of Mutant RAS Cancers –

Deciphera Pharmaceuticals, Inc. (DCPH) today announced the addition of a new candidate to its pipeline, DCC-3116, a potential first-in-class small molecule designed to inhibit cancer autophagy, a key tumor survival mechanism. DCC-3116, discovered using the Company’s novel switch control inhibitor platform, is designed to inhibit autophagy by inhibiting the ULK kinase. Autophagy is a cellular pathway that has been shown to be upregulated in mutant RAS cancers and that also mediates resistance to inhibitors of the RAS signaling pathway. Subject to favorable investigational new drug (IND)-enabling studies and filing and activation of an IND, Deciphera intends to develop DCC-3116 for the potential treatment of mutant RAS cancers in combination with inhibitors of downstream effector targets including RAF, MEK, or ERK inhibitors as well as with direct inhibitors of mutant RAS.

DCC-3116 Event and Webcast Information

Deciphera will host a live event and webcast to discuss the new program on Tuesday, June 18, 2019 at 8 a.m. ET. The event will feature members of the Deciphera management team and Channing Der, Ph.D., Sarah Graham Kenan Distinguished Professor, Department of Pharmacology, UNC School of Medicine, who is a leading expert in mutant RAS cancers and autophagy.

A live audio webcast of the event and accompanying slides may be accessed through the Investors section of Deciphera’s website at www.deciphera.com. A replay of the webcast will be available for 30 days following the event.

https://finance.yahoo.com/news/deciphera-pharmaceuticals-inc-expands-pipeline-110000100.html

Insys Therapeutics Files for Bankruptcy Following Legal Trouble

Days after agreeing to pay nearly $225 million in additional fines to the U.S. government for its fraudulent marketing schemes to boost sales of Subsys, Arizona-based Insys Therapeutics has filed for bankruptcy.

This morning the beleaguered company said it entered into bankruptcy protection in order to facilitate the sale of all of the company’s assets following its extensive legal problems stemming from past practices over the fraudulent practices the company used to increase the sales of its powerful opioid Subsys. Insys said it will continue to operate its business in the ordinary course of things while it pursues a court-supervised sale. Investors were not happy with the announcement. Shares of Insys plunged in premarket trading by nearly 69% to 90 cents per share. The stock had closed at $1.31 on Friday, a jump of nearly 14%.

The company predicted it might run out of cash several months ago. In March, Insys announced in a filing with the U.S. Securities and Exchange Commission that it did not have the assets to cover its legal obligations and would likely have to resort to the sale of its assets to cover those debts. Only weeks ago, Insys noted in its quarterly report that it had available cash of $87.6 million, which was well below what the company owed from the Subsys litigation, the $225 million it agreed to pay last week, as well as a $150 million agreement with the U.S. Department of Justice the company struck last fall. That announcement came after company founder John Kapoor and four co-defendants were found guilty of orchestrating kickback schemes to encourage doctors to boost prescriptions of Subsys.

Insys has sought to divest Subsys and other opioid-related products in its pipeline as the company hoped to reinvent itself to become a leader in pharmaceutical cannabinoids. Since 2016, the company had invested more than $200 million to effect that change.

As the company goes through the bankruptcy process, Insys said it will use existing cash on hand, as well as cash generated from operations, to continue its regular business practices, including the payment of all employee wages and benefits without interruption, as well as continuing programs offered to customers. The company said it also intends to pay its vendors and suppliers in full under normal terms while the bankruptcy proceedings are ongoing.

“After conducting a thorough review of available strategic alternatives, we determined that a court-supervised sale process is the best course of action to maximize the value of our assets and address our legacy legal challenges in a fair and transparent manner,” Insys Chief Executive Officer Andrew G. Long said in a statement.

Long added that the company has an assortment of compelling assets, as well as a “highly talented team.” He said the Chapter 11 process will provide the company the forum to “negotiate an equitable resolution” with its creditors and represents the best opportunity for the company.

Over the past year, Insys had sought several cost-cutting measures due to declining revenues. In July 2018, the company slashed 45 positions, 30 of which were part of the sales and marketing team. Insys cut another 48 employees in November 2018. The cuts in November were also primarily to the sales and marketing team, with 36 positions eliminated there.

https://www.biospace.com/article/insys-therapeutics-files-for-bankruptcy/

Merck Buys Tilos for Up to $773 Million to Expand Oncology Pipeline

Kenilworth, NJ-based Merck & Co. is buying Lexington, Mass.-based Tilos Therapeutics in a deal that could hit $773 million.

Tilos focuses on developing drugs that target the latency-associated peptide (LAP)-TGF beta complex to treat cancer, fibrosis and autoimmune diseases. TGF beta stands for transforming growth factor beta. The company was founded based on the research of Galina Gabriely and Howard Weiner at the Brigham and Women’s Hospital. Weiner’s work focused on serious autoimmune diseases, which led to LAP and the expression of LAP on suppressive cell populations. The laboratory developed antibodies to LAP, which have an effect on tumor growth.

“At Merck we continue to enhance our robust pipeline through active execution of our business development strategy,” stated Dean Li, Senior Vice President of Discovery and Translational Medicine at Merck Research Laboratories. “Tilos has developed a compelling portfolio of candidates that employ a novel approach to modulating the potent signaling molecule TGF beta by binding to latency-associated peptide, with potential applications across a range of disease indications.”

Under the terms of the deal, a Merck subsidiary is buying all outstanding shares of Tilos for a total of up to $773 million, including an upfront payment and various potential milestone payments.

Tilos was founded by Boehringer Ingelheim Venture Fund and Partners Innovation Fund. Additional investment was by ShangPharma Innovation Fund.

TGF beta is secreted with LAP. LAP creates a cage around TGF beta, holding it in an inactive state until it is needed. Research has indicated that anti-LAP antibodies block the release of TGF beta from the TGFB-LAP complex.

“We are proud that the Tilos team has advanced the discoveries of our scientific founders by developing a portfolio of anti-LAP antibodies designed to realize the full potential of TGFB-modulating therapeutics,” stated Barbara Fox, chief executive officer of Tilos. “This agreement with Merck, an industry leader in biopharmaceutical research and development, provides meaningful validation for our therapeutic approach and best positions our pipeline for broad clinical and commercial success.”

TGF beta is produced by a broad spectrum of immune cells. When activated, it can promote cancer by several different mechanisms, including angiogenesis and metastasis and by stimulating the development and differentiation of Tregs (T regulatory cells) and other immunosuppressive cell types. Tilos’ approach is to prevent the activation and release of mature TGF beta.

The primary focus has been in cancer with testing of the anti-TGFB antibodies with checkpoint inhibitors. The antibodies are being investigated in melanoma, glioblastoma and colorectal cancer. Other cancers include renal, hepatocellular, lung, breast and pancreatic cancers. It also has potential for treatments for various autoimmune diseases and fibrosis.

Merck is interested in ways of broadening the potential of its checkpoint inhibitor Keytruda (pembrolizumab). Although in many ways a miracle drug, only a small percentage of patients respond to checkpoint inhibitors like Keytruda. Anti-TGFB may help with the effectiveness of checkpoint inhibitors.

This deal is the third cancer-focused deal Merck has made recently. It acquired Immune Designin February for $300 million and in May bought Peloton Therapeutics for $2.2 billion.

https://www.biospace.com/article/merck-buys-tilos-in-potential-773-million-deal/

EHealth to announce guidance boost in Q2 call

In a regulatory filing, eHealth (EHTH -1.1%) discloses that it intends to announce an upward revision to its 2019 guidance during its Q2 earnings call (~July 25).

Current guidance: Revenue: $315M – 335M; Medicare segment revenue: $281M – 297M; EPS: $0.60 – 0.79; non-GAAP EPS: $1.54 – 1.73; non-GAAP EBITDA: $55M – 60M; cash consumption by operations: $20M – 25M.

Sell Side rating is Outperform. Quant rating is Neutral.

https://seekingalpha.com/news/3470112-ehealth-announce-guidance-boost-q2-call

Evolus Nuceiva nod in Europe may be extended 90 days

Evolus (EOLS -1.4%) reports that the expected approval of Nuceiva (prabotulinumtoxinA-xvfs)(branded as Jeuveau in the U.S.) by the European Commission may be delayed 90 days to allow it to review supplementary information that it requested from the European Medicines Agency and its advisory group CHMP.

In late April, CHMP adopted a positive opinion backing approval.

https://seekingalpha.com/news/3470122-nuceiva-nod-europe-may-extended-90-days