On September 5, 2019 Sumitomo Dainippon Pharma Co., Ltd. (TSE: 4506), a leading Japanese pharmaceutical company, and Roivant Sciences Ltd., a technology-enabled healthcare company, reported that they have entered into the Memorandum for the creation of a novel and broad Alliance to include the transfer to Sumitomo Dainippon Pharma of Roivant’s ownership interests in 5 of their biopharmaceutical companies ("Vants"), with options to acquire up to 6 additional Vants, and access to Roivant’s proprietary technology platforms, DrugOme and Digital Innovation (Press release, Sumitomo Dainippon Pharma, SEP 5, 2019, View Source [SID1234539322]). Roivant will collaborate with Sumitomo Dainippon Pharma with the continued involvement of Roivant’s senior leaders to ensure the success of the Alliance. In addition, Sumitomo Dainippon Pharma will take an equity stake of over 10% of shares outstanding in Roivant.

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"We respect Roivant’s innovative business model and underlying culture, and we look forward to deepening our relationship with Roivant, which has a rich development pipeline, technology platforms, and distinctive talents," said Hiroshi Nomura, Representative Director, President and Chief Executive Officer of Sumitomo Dainippon Pharma. "I am hopeful that through this Alliance between the two companies, Sumitomo Dainippon Pharma will not only obtain growth engines after expiry of the U.S. market exclusivity of LATUDA, but also address issues identified in the Mid-term Business Plan 2022 and contribute significantly to establish a position as a ‘Global Specialized Player’ which we aspire to be by 2033 through our transformation into a novel pharmaceutical business model leveraging data and digital technologies."

"We are pleased to enter into this relationship with Sumitomo Dainippon Pharma and we look forward to working closely with them to ensure the success of the Alliance," said Vivek Ramaswamy, Founder and Chief Executive Officer of Roivant. "Sumitomo Dainippon’s expertise in commercializing major products globally, combined with support from our technology-oriented Vants and the central Roivant platform, will enhance the value of the product portfolio included in this Alliance. We view this partnership as a major validation of the Roivant platform and we will continue to launch other innovative Vants in the future."

Structure of the Alliance

Pursuant to the Memorandum, the Sumitomo Dainippon-Roivant Alliance, a new entity to be wholly owned by Sumitomo Dainippon Pharma, is expected to assume Roivant’s ownership interests in Myovant Sciences (women’s health and prostate cancer), Urovant Sciences (urinary diseases), Enzyvant Therapeutics (pediatric rare diseases), Altavant Sciences (respiratory rare diseases), and one additional company to be specified before the execution of the definitive agreement. Sumitomo Dainippon Pharma will also gain options to acquire Roivant’s ownership interests in up to 6 additional biopharmaceutical Vants. These 11 Vants collectively have more than 25 innovative clinical programs, with multiple potential product launches expected from 2020 to 2022.

Sumitomo Dainippon Pharma plans to support the Vants in the Alliance by leveraging the potential benefits of scale and other advantages associated with Sumitomo Dainippon Pharma’s global commercial infrastructure such as market access and drug distribution. Roivant also plans to continue to support the six Vants subject to the option. Sumitomo Dainippon and Roivant will further collaborate with the goal of successfully progressing each of the Vants’ ongoing programs.

Access to Technology Platforms

Sumitomo Dainippon Pharma will gain key elements of Roivant’s proprietary technology platform, including the DrugOme, which assists in accelerating pipeline acquisition and clinical development, and Digital Innovation, which uses technology to improve business processes. These platforms will continue to be used by Roivant under separate contract for other Vants as well as future business activities. Sumitomo Dainippon Pharma also expects to enter contract agreements with Roivant Health technology Vants, including Datavant and Alyvant, to support its own ongoing and future clinical and commercialization activities and maximize the value of its product portfolio, including products in the Sumitomo Dainippon-Roivant Alliance.

Timeline for Definitive Agreement

Roivant and Sumitomo Dainippon Pharma expect to sign the definitive agreement by the end of October 2019. The transaction will be subject to customary closing conditions and any required governmental approvals. Roivant is expected to receive USD $3 billion from Sumitomo Dainippon Pharma as an upfront payment to enter the Alliance, which includes taking a substantial equity ownership interest in Roivant (over 10% of shares outstanding).

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.

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 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 Genprex, Inc. (NASDAQ: GNPX), a clinical-stage gene therapy company, reported that it will present at the H.C. Wainwright 21st Annual Global Investment Conference on September 10, 2019 in New York City (Press release, Genprex, SEP 5, 2019, View Source [SID1234539317]).

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Genprex’s Chairman and Chief Executive Officer, Rodney Varner, will lead the company’s presentation and will be available for one-on-one meetings.

Genprex will present at the H.C. Wainwright 21st Annual Global Investment Conference as follows:

Date: Tuesday, September 10, 2019

Time: 3:00-3:25 p.m. EDT

Venue: Lotte New York Palace Hotel, New York City

Room: Holmes I (4th Floor)

Several networking opportunities are still available to investors or delegates of other companies that may wish to meet the Genprex team one-on-one. Those interested in setting a meeting are asked to contact the company at [email protected].