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ELMD Breathes Easy, TNDM Ups Outlook, OPNT To Report Bulimia Nervosa Data In Q1

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Today's Daily Dose brings you news about stock offerings of AnaptysBio and Opiant Pharma; Entasis Therapeutics' IPO; Cidara's lead antifungal product candidate, Rezafungin, securing Qualified Infectious Disease Product and Fast Track designations, and Tandem Diabetes' revised sales outlook for 2018.

Read on...

AnaptysBio Inc. (ANAB) has offered to sell 2.2 million shares of common stock at a public offering price of $94.46 each. The underwriters have a 30-day option to purchase up to an additional 330,000 shares of its common stock.

Gross proceeds to AnaptysBio from the offering are expected to be approximately $207.8 million. The offering is expected to close on or about September 28, 2018 subject to customary closing conditions.

The Company recently reported positive results from its ongoing single dose phase IIa clinical trial of Etokimab in adult patients with severe eosinophilic asthma. A multi-dose phase IIb trial of Etokimab in eosinophilic asthma is expected to be initiated in 2019.

ANAB closed Tuesday's trading at $94.46, down 7.35%.

Cidara Therapeutics Inc.'s (CDTX) lead antifungal product candidate, Rezafungin for injection, a prophylaxis (prevention) development program, has been granted both Qualified Infectious Disease Product and Fast Track designations by the FDA.

Rezafungin is being studied to address unmet needs in the treatment of candidemia and invasive candidiasis as well as for prophylaxis of invasive fungal infections due to common fungal pathogens: Candida, Aspergillus and Pneumocystis.

The Company plans to commence phase III prophylaxis clinical trial of Rezafungin in patients undergoing allogeneic bone marrow transplantation, dubbed ReSPECT, in the first quarter of 2019.

CDTX closed Tuesday's trading at $4.45, up 5.95%.

Electromed Inc. (ELMD) delivered strong top and bottom-line growth for fiscal fourth quarter ended June 30, 2018.

Net income for the recent fourth quarter expanded 18.2% to $1.1 million or $0.13 per share on net revenue of $8.2 million. This compared with net income of $946,000, or $0.11 per share and net revenue of $7.3 million for the three months ended June 30, 2017.

At June 30, 2018, the Company had cash of $7.5 million, long-term debt including current maturities of $1.1 million, working capital of $17.5 million, and shareholders' equity of $21.9 million.

ELMD closed Tuesday's trading at $5.50, down 6.78%.

Entasis Therapeutics Holdings Inc. has priced its initial public offering of 5 million shares of its common stock at a public offering price of $15.00 each.
The common stock is expected to begin trading on The Nasdaq Global Market on September 26, 2018 under the trading symbol "ETTX."

The offering is expected to close on September 28, 2018, subject to customary closing conditions, and the gross proceeds to Entasis are expected to be approximately $75 million.

The underwriters have a 30-day option to purchase up to 750,000 additional shares of common stock.

The Company's most-advanced drug candidate is ETX2514SUL in the treatment of complicated urinary tract infections (cUTI) including acute pyelonephritis (kidney infection) in adults. Positive top-line results from this study were reported in August of this year. ETX2514SUL is expected to move into phase III trial in the first quarter 2019.

Also in the pipeline are Zoliflodacin, which successfully completed a phase II study in individuals with uncomplicated gonorrhea in December 2015; ETX0282, being developed as an oral therapy for infections caused by multidrug-resistant (MDR) Gram-negative pathogens, including MDR and carbapenem-resistant Enterobacteriaceae (CRE), currently in phase I trial in healthy volunteers, and NBP program for Gram-negative infections, in pre-clinical testing.

Molecular Templates Inc. (MTEM) has closed its underwritten public offering of 9.43 million shares of its common stock, which includes the exercise in full by the underwriters of their option to purchase 1,230,000 additional shares of common stock, at a price to the public of $5.50 per share.

The gross proceeds to Molecular from the offering are expected to be approximately $52 million.

The Company expects to initiate Phase II combination studies with MT-3724 in earlier lines of diffuse large B-cell lymphoma in 2H18. An update on the Phase Ib extension study of MT-3724 is expected in 4Q18, and a Phase II monotherapy study is expected to start at the end of 2018 which has the potential to be a pivotal study.

MTEM closed Tuesday's trading at $5.21, down 5.27%.

Opiant Pharmaceuticals Inc. (OPNT) has offered to sell 705,882 shares of its common stock at a price of $17.00 per share. The gross proceeds from the offering are expected to be approximately $12 million.

The underwriters have a 30-day option to purchase up to 105,882 additional shares of common stock.

The offering is expected to close on or about September 27, 2018, subject to customary closing conditions.

Near-term Catalyst:

A phase II clinical trial of OPTN001, a naloxone nasal spray, for the treatment of Bulimia Nervosa, is underway. The Company expects to report top-line data from this trial in the first quarter of 2019.

Bulimia Nervosa is a serious and potentially life-threatening eating disorder affecting mainly females, and is characterized by binge eating followed by purging, fasting, and other strategies to prevent weight gain.

OPNT closed Tuesday's trading at $17.35, down 18.62%.

Portola Pharmaceuticals' (PTLA) Cerdulatinib, an investigational, oral Syk/JAK inhibitor for the treatment of peripheral T-cell lymphoma, has been granted Orphan Drug Designation by the FDA.

Cerdulatinib is being developed to treat patients with follicular lymphoma (FL), PTCL, and other hematologic cancers, specifically those who have relapsed or who have not responded to prior therapies.

A phase IIa study evaluating the safety and efficacy of Cerdulatinib in patients with relapsed/refractory B-cell malignancies who have failed multiple therapies is underway.

PTLA closed Tuesday's trading at $27.69, up 1.99%.

Tandem Diabetes Care Inc. (TNDM) has increased its 2018 sales guidance to $150 million to $158 million from its prior forecast range of $140 million to $148 million, following continued strong domestic sales in the third quarter and the recent launch of the t:slim X2 Insulin Pump in select international markets.

In full year 2017, the Company reported sales of approximately $108 million, and the revised guidance range represents annual sales growth of 39 percent to 47 percent.

TNDM closed Tuesday's trading at $47.84, up 7.43%.

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