On September 5, 2019 Merrimack Pharmaceuticals (Nasdaq: MACK) (the "Company" or "Merrimack") reported that the dividend amount for the previously authorized and declared $20 million special cash dividend (the "Special Dividend") announced on July 25, 2019 is $1.496675 per outstanding share of Merrimack common stock (Press release, Merrimack, SEP 5, 2019, View Source [SID1234539318]). The dividend will be paid today, September 5, 2019, as previously announced, to stockholders of record as of the close of business on August 28, 2019.

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The Company is focused on executing its carefully constructed plan to conserve cash and maximize value for shareholders, including distributing all of the more than $500 million in potential milestone payments the Company is eligible to receive, net of any taxes owed. The Special Dividend is consistent with implementing the Company’s strategic plan and, as opportunities arise, Merrimack will continue to look to distribute any excess cash deemed not essential to the Company’s minimal operations required to preserve its ability to capture all remaining potential milestones.

"Consistent with the Board of Directors’ strategic review and Merrimack’s prior communications, we are committed to maximizing the distribution of cash and milestone payments to our shareholders going forward," said Gary Crocker, Chairman of Merrimack’s Board of Directors. "This dividend is part and parcel of that steadfast commitment."

U.S. Federal Tax Treatment of the Special Dividend

Merrimack currently estimates that, for U.S. federal tax purposes, 100% of the Special Dividend (or approximately $1.50 per share) will likely be first treated as a return on capital to stockholders to the extent of their basis in Merrimack common stock, and then as capital gain.

The tax treatment of the Special Dividend will be based on Merrimack’s current and accumulated earnings and profits for Merrimack’s 2019 fiscal year ending December 31, 2019 ("FY19"). The process of determining current and accumulated earnings and profits requires a final determination of Merrimack’s financial results for FY19 and a review of certain other factors. The determination will be based in part on factors that are outside of the control of Merrimack and which cannot be ascertained at this time. Merrimack does not expect the calculation of the portion that will be treated as a taxable dividend for federal tax purposes to be finalized until after the completion of FY19. Accordingly, the portion of the Special Dividend estimated to be a taxable dividend provided in this release is based upon currently available information and is subject to change.

The precise tax impact of the Special Dividend to specific stockholders depends upon the stockholder’s individual tax situation. Stockholders are advised to consult with their personal tax advisors.

No NOL Impairment as of July 24, 2019

The Company engaged a leading global tax advisor to complete an evaluation of ownership changes through July 24, 2019 to refresh a recent study and assess whether utilization of the Company’s net operating loss carryforwards ("NOLs") would be subject to an annual limitation under Section 382 of the Internal Revenue Code. As a result of this analysis, the Company believes it can utilize all of its existing tax net operating loss carryforwards. Any future impairment of the NOLs caused by a transaction that triggers an ownership change or use of the NOLs for other purposes could reduce these returns to shareholders. Merrimack is committed to monitoring the status of the Company’s NOLs and refreshing its Section 382 study as needed on a periodic basis to prevent any future impairments in order to maximize potential future distributions to shareholders.

Merrimack’s Board has consistently been focused on the value of the Company’s NOLs. The NOLs were fully incorporated into the recent strategic review and it was determined by the Company that the best use of the NOLs would be to shield potential tax payments related to the milestones in order to maximize distributions to shareholders.

On September 5, 2019 Pfenex Inc. (NYSE American: PFNX) reported that it has earned an $11 million development milestone under its development and license agreement with Jazz Pharmaceuticals (Press release, Pfenex, SEP 5, 2019, View Source [SID1234539335]). The milestone is associated with process development activities for PF745, a recombinant crisantaspase with half-life extension technology.

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"We are very pleased with our progress on PF745 and we believe the Jazz collaboration overall further validates the versatility of our proprietary protein expression platform and the quality of our development capabilities," said Eef Schimmelpennink, Chief Executive Officer of Pfenex. "Similarly, we are appreciative of the progress recently reported by Jazz on PF743 (JZP-458) with the completion of the Phase 1 study and announcement of plans to initiate a Phase 2/3 study later in 2019."

Under the terms of the development and license agreement, Pfenex is eligible to receive an aggregate total of up to $224.5 million in development and sales milestone fees, of which $177.5 million is still eligible to be received by Pfenex. Of this $177.5 million, $18.5 million are development milestones, $34 million are regulatory milestones, and $125 million are sales milestones. Pfenex may also be eligible to receive tiered royalties on worldwide sales of any products resulting from the collaboration.

On September 5, 2019 Deciphera Pharmaceuticals, Inc. (Nasdaq:DCPH), a clinical-stage biopharmaceutical company focused on addressing key mechanisms of tumor drug resistance, reported that data from the Company’s INVICTUS pivotal Phase 3 study of ripretinib in patients with fourth-line and fourth-line plus gastrointestinal stromal tumors (GIST) has been selected as an oral presentation at the European Society for Medical Oncology (ESMO) (Free ESMO Whitepaper) 2019 Congress to be held September 27 – October 1, in Barcelona, Spain (Press release, Deciphera Pharmaceuticals, SEP 5, 2019, View Source [SID1234539302]).

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"We look forward to the first presentation of the INVICTUS Phase 3 data in an oral session at ESMO (Free ESMO Whitepaper) later this month," said Steve Hoerter, President and Chief Executive Officer of Deciphera. "The INVICTUS data have given us confidence that ripretinib has the potential to fundamentally transform the treatment paradigm for patients with advanced GIST who have no approved treatment options. We expect that these data will serve as the basis for our first NDA, which we plan to submit in the first quarter of 2020."

Presentation information is as follows:

Session Type: Late-Breaking Abstract, Proffered Paper Session
Session Title: Proffered Paper – Sarcoma (ID 249)
Title: INVICTUS: A Phase 3, INterVentional, Double-Blind, Placebo-Controlled Study to Assess the Safety and Efficacy of Ripretinib as ≥4th-Line Therapy In Patients With AdvanCed Gastrointestinal Stromal TUmorS (GIST) Who have Received Treatment With Prior Anticancer Therapies (NCT03353753) (ID 4794)
Presentation Number: LBA87
Date and Time: Monday, September 30, 2:45 – 2:57 PM CET
Location:Malaga Auditorium (Hall 5)
Speaker: Margaret von Mehren, MD, Department of Medical Oncology, Fox Chase Cancer Center, Philadelphia, Pennsylvania

About Ripretinib

Ripretinib is an investigational KIT and PDGFRα kinase switch control inhibitor in clinical development for the treatment of KIT and/or PDGFRα-driven cancers, including gastrointestinal stromal tumors, or GIST, systemic mastocytosis, or SM, and other cancers. Ripretinib was specifically designed to improve the treatment of patients with GIST by inhibiting a broad spectrum of mutations in KIT and PDGFRα. Ripretinib is a KIT and PDGFRα inhibitor that inhibits initiating and secondary KIT mutations in exons 9, 11, 13, 14, 17, and 18, involved in GIST, as well as the primary D816V exon 17 mutation involved in SM. Ripretinib also inhibits primary PDGFRα mutations in exons 12, 14 and 18, including the exon 18 D842V mutation, involved in a subset of GIST. In June 2019, the U.S. FDA granted Fast Track Designation to ripretinib for the treatment of patients with advanced GIST who have received prior treatment with imatinib, sunitinib and regorafenib.

Deciphera Pharmaceuticals has an exclusive license agreement with Zai Lab (Shanghai) Co., Ltd. for the development and commercialization of ripretinib in Greater China (MainlandChina, Hong Kong, Macau and Taiwan). Deciphera Pharmaceuticals retains development and commercial rights for ripretinib in the rest of the world.

On September 5, 2019 OncoNano Medicine, Inc. reported that ONM-100 will be featured at the World Molecular Imaging Congress (WMIC), which is being held September 4-7, 2019 in Montreal (Press release, OncoNano Medicine, SEP 5, 2019, View Source [SID1234539319]). The presentation will include results from a Phase 1 clinical trial of ONM-100 as an intraoperative tumor imaging agent as well as information about OncoNano’s pH-sensitive micelle technology platform.

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"We are excited to share these promising clinical trial results for ONM-100 at WMIC this year, as many of the world’s foremost experts in molecular imaging will be in attendance," commented Ravi Srinivasan, Ph.D., CEO of OncoNano. "ONM-100 is designed to take advantage of one of cancer’s simplest biomarkers – acidic pH – to image tumor resection borders regardless of tissue origin and meaningfully improve the accuracy of tumor detection."

OncoNano’s proprietary pH-sensitive micelles exploit a unique feature of cancer cell metabolism – excess acid. This metabolic defect creates a tumor microenvironment that is acidic relative to normal tissue and enables pH to be used as a stable biomarker of the diseased tissue. OncoNano is developing multiple product candidates using their pH-sensitive micelle platform, which are ultra-sensitive to subtle changes in pH that trigger dissociation when exposed to acidic environments. Thus, the micelle is activated preferentially in the tumor microenvironment to initiate tagging of the tumor but remains intact when exposed to normal physiological pH levels.

Full details of the presentation are listed below:

TITLE:

Metabolic Acidosis in Cancer: A New Strategy Using a pH Transistor Nanoprobe for Fluorescence-Guided Surgery in Humans

PRESENTER:

Pieter J. Steinkamp, M.D., University Medical Center Groningen, the Netherlands

DATE:

September 7, 2019

TIME:

2:30 PM EDT

LOCATION:

Palais des congrès de Montréal, Room 519a

About ONM-100
Surgical tumor resection remains a critical tool of oncology medicine, but detection of tumor borders and residual tumors is notoriously difficult. ONM-100, which utilizes OncoNano’s ultra pH-sensitive micelle platform, is a tumor-agnostic intraoperative tumor imaging agent currently in Phase 2 clinical trials. ONM-100 is designed to be injected intravenously prior to surgery and tags diseased cancerous tissue to provide real-time detection of tumor borders and residual tumors with commercially available imaging equipment. ONM-100 was partially funded for clinical research by the Cancer Prevention and Research Institute of Texas.

On September 5, 2019 AngioDynamics, Inc. (NASDAQ: ANGO), a leading provider of innovative, minimally invasive medical devices for vascular access, peripheral vascular disease, and oncology, reported that it will report financial results for the first quarter of fiscal year 2020 before the market open on Thursday, October 3, 2019 (Press release, , SEP 5, 2019, View Source [SID1234539320]). The Company’s management will host a conference call at 8:00 a.m. ET the same day to discuss the results.

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To participate in the conference call, dial 1-877-407-0784 (domestic) or +1-201-689-8560 (international) and refer to the passcode 13694372.

This conference call will also be webcast and can be accessed from the "Investors" section of the AngioDynamics website at www.angiodynamics.com. The webcast replay of the call will be available at the same site approximately one hour after the end of the call.

A recording of the call will also be available from 11:00 a.m. ET on Thursday, October 3, 2019, until 11:59 p.m. ET on Thursday, October 10, 2019. To hear this recording, dial 1-844-512-2921 (domestic) or +1-412-317-6671 (international) and enter the passcode 13694372.