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ATOS Skyrockets, BPMX Gets "Going Concern" Warning, Respite For KPTI

pharma daily 071918 15mar19 lt

Today's Daily Dose brings you news about the positive progress of Atossa Genetics' Oral Endoxifen as a post-mastectomy treatment for breast cancer; BioLife Solutions' stellar fourth-quarter financial results; BioPharmX Corp's anticipated milestones in 2019; revised FDA decision date of Karyopharm's Selinexor; and clinical trial catalysts of SCYNEXIS.

Read on...

Shares of Atossa Genetics Inc. (ATOS) jumped more than 350% on Thursday, following FDA approval of Oral Endoxifen for "expanded access" as post-mastectomy treatment for a U.S. breast cancer patient. This patient completed a 3-week course of Atossa's oral Endoxifen prior to her surgery under an FDA-approved expanded access program.

Commenting on the development, Steven C. Quay, President and CEO of Atossa, said, " We are extremely pleased that this patient not only benefitted from Endoxifen prior to her surgery, but that the FDA agrees that continued Endoxifen therapy is appropriate for this pre-menopausal patient."

Under the FDA expanded access IND program, the use of Atossa's proprietary oral Endoxifen is restricted solely to this patient. Approval from the Institutional Review Board (IRB) must be obtained prior to providing oral Endoxifen to this patient.

A phase II study of topical Endoxifen in women with mammographic breast density (MBD) is underway, with study completion expected in the second quarter of 2019.

ATOS closed Thursday's trading at $7.07, up 368.21%.

BioLife Solutions Inc. (BLFS) reversed to profit in the fourth quarter and full year ended December 31, 2018, helped by higher revenues.

Net income attributable to common stockholders for the fourth quarter of 2018 was $833 thousand or $0.04 per share compared with a net loss of $664 thousand or $0.05 per share for the fourth quarter of 2017.

Total revenue for the fourth quarter of 2018 increased to $5.5 million from $3.1 million in the year-ago same quarter.

Gross margin for the fourth quarter of 2018 was 69% compared with 59% in the fourth quarter of 2017.

For the full year of 2019, total revenue is expected to be in the range of $27 million to $30 million. The total revenue in 2018 was $19.7 million.

In other news, the Company announced that it has entered into an agreement to acquire Astero Bio Corporation, a privately-held innovator in the design, development and commercialization of novel automated thawing devices, for an upfront cash payment of $8.0 million.

BLFS closed Thursday's trading at $17.69, up 4.74%.

BioPharmX Corporation (BPMX) anticipates reporting top-line data from its phase IIb clinical trial of BPX-041 for the treatment of papulopustular rosacea in July 2019.

As of January 31, 2019, the Company had cash and cash equivalents of $3.1 million.

In the latest 10-K filed March 14, 2019, with SEC for the fiscal year ended on January 31, 2019, the auditor has raised substantial doubt about the Company's ability to continue as a going concern.

BPMX closed Thursday's trading at $0.10, down 1.67%.

The FDA decision on Karyopharm Therapeutics Inc.'s (KPTI) Selinexor, proposed for the treatment of patients with relapsed refractory multiple myeloma, has been extended by three months to July 6, 2019.

Selinexor is under priority review by the FDA, and the original decision date was April 6, 2019. Last month, an FDA panel, which reviewed the Selinexor New Drug Application, voted 8 to 5 recommending that the U.S. regulatory agency wait for the results from Karyopharm's phase III study of Selinexor, dubbed BOSTON, before making a final decision regarding approval.

Following the panel's review, Karyopharm submitted additional, existing clinical information as an amendment to the NDA, resulting in the FDA delaying the action by three months.

KPTI closed Thursday's trading at $4.40, down 0.45%. In after-hours, the stock was up 29.32% to $5.69.

Organogenesis Holdings Inc. (ORGO) has announced a new credit agreement with Silicon Valley Bank, the lead agent, and MidCap Financial.

The agreement provides for a credit facility in the aggregate principal amount of $100 million, consisting of a $60 million term loan facility and a $40 million revolving credit facility.

The proceeds from the term loan and revolving credit facility will be used for general corporate purposes and the repayment of the Company's existing credit facility and a lease with Eastward Capital Partners.

Organogenesis is a regenerative medicine company focused on the development, manufacture, and commercialization of product solutions for the Advanced Wound Care and Surgical and Sports Medicine market.

The Company is slated to report fourth quarter and fiscal year 2018 financial results after the market closes on Monday, March 18.

ORGO closed Thursday's trading at $9.52, up 0.21%. In after-hours, the stock was up 8.19% to $10.30.

SCYNEXIS Inc. (SCYX) expects to report top-line data from its phase III VANISH program, evaluating oral Ibrexafungerp for the treatment of acute vulvovaginal candidiasis, in the first half of 2020.

The VANISH program is comprised of two Phase 3 clinical trials (approximately 350 patients each) designed to evaluate the efficacy of a one-day 600mg oral dose of Ibrexafungerp versus placebo for the treatment of vulvovaginal candidiasis or VVC.

If all goes well as planned, the Company expects to submit Ibrexafungerp New Drug Application in the second half of 2020.

A third phase III clinical trial (approximately 350 patients) evaluating the safety and efficacy of oral 600mg Ibrexafungerp, given once-a-month for six months, versus placebo for the prevention of recurrent VVC is also track to be initiated.

A phase III study of Ibrexafungerp in patients with refractory or intolerant fungal disease, dubbed FURI, is also ongoing. The Company announced positive results from the first interim efficacy analysis of the ongoing FURI study in January of this year.

The other ongoing clinical trials are:

A phase III open-label, single-arm study evaluating oral Ibrexafungerp for the treatment of Candida auris infections, dubbed CARES study, and a phase II study of oral Ibrexafungerp in combination with voriconazole for the treatment of invasive aspergillosis, dubbed SCYNERGIA.

The Company also continues to explore the development of IV formulation of Ibrexafungerp.

SCYX closed Thursday's trading at $1.58, up 25.40%.

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