On November 7, 2018 Sysmex Corporation reported that actual financial results during the six months ended September 30, 2018, differed in some respects from the forecast announced on May 9, 2018 (Press release, Sysmex, NOV 7, 2018, View Source [SID1234530822]). In addition, Sysmex
has revised its financial forecast for the full fiscal year ending March 31, 2019. These differences are described below.

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1. Differences between Actual and Forecast of Consolidated Financial Results for the Six Months Ended September 30, 2018 (April 1, 2018 to September 30, 2018)

Reasons for the Differences and Revision
On the consolidated sales front, in the first six months of the fiscal year ending March 31, 2019, sales in the Japan and EMEA regions were lower than previously forecast. As for profit, we worked to curtail selling, general and administrative expenses, but these reductions were unable to overcome the impact on profits of lower-than-expected sales. In addition, we recorded an exchange loss. As a result, operating profit, profit before tax and profit attributable to owners of the parent were lower than previously forecast.

Consequently, we have revised downward our forecast for the full fiscal year ending March 31, 2019, as we now expect sales, operating profit, profit before tax and profit attributable to owners of the parent to be below our previously forecast figures.

The foreign exchange assumptions used for calculating financial forecasts from the third quarter onward remain unchanged from our initial assumptions, at US$1.00 = ¥110 and €1 = ¥130.

On November 7, 2018 Karyopharm Therapeutics Inc. (Nasdaq:KPTI), a clinical-stage pharmaceutical company, reported that the U.S. Food and Drug Administration (FDA) has granted Fast Track designation to selinexor, the Company’s first-in-class, oral SINE compound for the treatment of patients with diffuse large B-cell lymphoma (DLBCL) who have received at least two prior therapies and are not eligible for high dose chemotherapy with stem cell rescue or CAR-T therapy (Press release, Karyopharm, NOV 7, 2018, View Source [SID1234530907]). Selinexor is currently being studied in the ongoing Phase 2b SADAL study in patients with relapsed or refractory DLBCL who are not eligible for stem cell transplantation for which top-line results will be presented at the upcoming American Society of Hematology (ASH) (Free ASH Whitepaper) 2018 Annual Meeting.

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Karyopharm previously received Fast Track Designation for selinexor as a potential new treatment for patients with penta-refractory multiple myeloma who have received at least three prior lines of therapy. In October 2018, the U.S. FDA accepted Karyopharm’s New Drug Application for selinexor seeking accelerated approval as a new treatment for patients with penta-refractory multiple myeloma. The FDA has assigned a Priority Review and given an action date of April 6, 2019 under the Prescription Drug User-Fee Act (PDUFA).

The FDA’s Fast Track program facilitates the development of drugs intended to treat serious conditions and that have the potential to address unmet medical needs. A drug program with Fast Track status is afforded greater access to the FDA for the purpose of expediting the drug’s development, review and potential approval. In addition, the Fast Track program allows for eligibility for Accelerated Approval and Priority Review, if relevant criteria are met, as well as for Rolling Review, which means that a drug company can submit completed sections of its New Drug Application (NDA) for review by FDA, rather than waiting until every section of the NDA is completed before the entire application can be submitted for review.

"The receipt of Fast Track designation from the FDA for selinexor in relapsed DLBCL underscores the great unmet medical need for this aggressive form of lymphoma," said Sharon Shacham, PhD, MBA, Founder, President and Chief Scientific Officer of Karyopharm. "Pending positive results from the Phase 2b SADAL study, we plan to submit a second NDA to the FDA in the first half of 2019, with a request for accelerated approval, for oral selinexor as a potential new treatment for patients with relapsed or refractory DLBCL."

About the Phase 2b SADAL Study

The multicenter, open-label Phase 2b SADAL (Selinexor Against Diffuse Aggressive Lymphoma) study is evaluating oral selinexor in patients with relapsed or refractory DLBCL who have received two to five prior therapies and who are not currently eligible for hematopoietic stem cell transplantation. In this study, approximately 125 patients will receive 60mg oral selinexor twice weekly in 4-week cycles. At least 50% of study participants must have the GCB sub-type. Objective response rate is the primary endpoint of the study, with duration of response a key secondary endpoint.

About Selinexor

Selinexor is a first-in-class, oral Selective Inhibitor of Nuclear Export (SINE) compound. Selinexor functions by binding with and inhibiting the nuclear export protein XPO1 (also called CRM1), leading to the accumulation of tumor suppressor proteins in the cell nucleus. This reinitiates and amplifies their tumor suppressor function and is believed to lead to the selective induction of apoptosis in cancer cells, while largely sparing normal cells. To date, over 2,800 patients have been treated with selinexor. In April and September 2018, Karyopharm reported positive data from the Phase 2b STORM study evaluating selinexor in combination with low-dose dexamethasone in patients with penta-refractory multiple myeloma. Selinexor has been granted Orphan Drug Designation in multiple myeloma and Fast Track designation for the patient population evaluated in the STORM study. Karyopharm’s New Drug Application (NDA) has been accepted for filing and granted Priority Review by the FDA, and oral selinexor is currently under review by the FDA as a possible new treatment for patients with penta-refractory multiple myeloma. The Company also plans to submit a Marketing Authorization Application (MAA) to the European Medicines Agency (EMA) in early 2019 with a request for conditional approval. Selinexor is also being evaluated in several other mid-and later-phase clinical trials across multiple cancer indications, including in multiple myeloma in a pivotal, randomized Phase 3 study in combination with Velcade (bortezomib) and low-dose dexamethasone (BOSTON), as a potential backbone therapy in combination with approved therapies (STOMP), in diffuse large B-cell lymphoma (SADAL), liposarcoma (SEAL), and an investigator-sponsored study in endometrial cancer (SIENDO), among others. Additional Phase 1, Phase 2 and Phase 3 studies are ongoing or currently planned, including multiple studies in combination with approved therapies in a variety of tumor types to further inform Karyopharm’s clinical development priorities for selinexor. Additional clinical trial information for selinexor is available at www.clinicaltrials.gov.

On November 7, 2018 XOMA Corporation (Nasdaq: XOMA) ("XOMA" or the "Company") reported its intent to commence a rights offering pursuant to which the Company would raise approximately $20 million through the distribution of subscription rights to holders of its common stock and Series X preferred stock, which will entitle the holders to purchase shares of XOMA’s common stock at $13.00 per share (the "Rights Offering") (Press release, Xoma, NOV 7, 2018, View Source [SID1234531171]). The offering will be fully backstopped by BVF Partners L.P., the Company’s largest stockholder, which has agreed to purchase at a minimum its as-converted pro rata share of the offering amount, and will purchase an additional amount of securities, up to a total of approximately $20 million, that are not subscribed for by the Company’s other stockholders in the rights offering.

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Under the proposed Rights Offering, the Company plans to distribute non-transferable subscription rights to purchase a portion of a share of Common Stock for each share of Common Stock outstanding and for each share of common stock issuable on conversion of the Company’s outstanding shares of Series X Preferred Stock, at a subscription price per share of $13.00, to its stockholders of record as of the close of business on November 16, 2018 (the "Record Date"). The subscription rights will be exercisable for up to an aggregate of approximately 1,538,460 shares of Common Stock, with participation to be allocated among holders of its Common Stock and Series X Preferred Stock on a pro rata basis (assuming full conversion of the Series X Preferred Stock into shares of Common Stock), subject to the aggregate offering threshold and ownership limitations. The subscription rights are non-transferable and may be exercised only during the anticipated subscription period of Monday, November 19, 2018, through 5:00 PM EDT on Friday, December 14, 2018, unless extended. Any participant in the Rights Offering that, by exercise of its subscription right would become a holder of greater than 9.9% of the outstanding number of shares of Common Stock of the Company following the offering may elect to instead purchase Series Y Preferred Stock of the Company. The company intends to sell the Series Y Preferred Stock at $13,000 per share, and any such holder so electing would have a right to purchase one one-thousandth of a share of Series Y Preferred Stock for each share of Common Stock it had a right to purchase under the subscription rights. Each share of Series Y Preferred Stock will, subject to certain limitations, be convertible into 1,000 shares of common at the election of the holder. The Series Y Preferred Stock will generally have no voting rights, except as required by law, and will participate pari passu with any distribution of proceeds to holders of Common Stock in the event of the Company’s liquidation, dissolution or winding up.

The Rights Offering will be made pursuant to the Company’s effective shelf registration statement on file with the Securities and Exchange Commission ("SEC") and only by means of a prospectus supplement and accompanying prospectus. The Company expects to mail subscription certificates evidencing the subscription rights and a copy of the prospectus supplement and accompanying prospectus for the Rights Offering shortly following the Record Date.

This press release is not intended to and does not constitute an offer to sell or the solicitation of an offer to subscribe for or buy or an invitation to purchase or subscribe for any securities in any jurisdiction, nor shall there be any sale, issuance or transfer of securities in any jurisdiction in contravention of applicable law. No offer of securities shall be made except by means of a prospectus meeting the requirements of Section 10 of the Securities Act of 1933, as amended.

BVF Partners L.P., the Company’s largest shareholder, owning approximately 17.9% of the Company’s outstanding common stock (and 48.6% on an as-converted basis), will backstop the Rights Offering and has agreed to purchase up to $20 million of Series Y Preferred Stock at price of $13,000 per share in a private placement within five days of conclusion of the Rights Offering, with the dollar amount to be purchased in such private placement reduced by the dollar amount sold by the Company (including to BVF Partners L.P., and its affiliates), in the Rights Offering.

On November 7, 2018 Navidea Biopharmaceuticals, Inc. (NYSE American: NAVB) ("Navidea" or the "Company"), a company focused on the development of precision immunodiagnostic agents and immunotherapeutics, reported its financial results for the third quarter of 2018 (Press release, Navidea Biopharmaceuticals, NOV 7, 2018, View Source [SID1234531187]). Navidea reported total revenues for the quarter of $231, 000. Net loss attributable to common stockholders was $3.8 million.

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"Navidea had a productive quarter as we advanced the business and our novel imaging pipeline," said Mr. Jed A. Latkin, Chief Executive Officer of Navidea. "We also continued to gain recognition from the scientific and medical communities, receiving acceptance into the National Institutes of Health’s ("NIH") Commercialization Accelerator Program and presenting encouraging data on Tc99m tilmanocept, the first product developed and commercialized by the Company based on the Manocept platform, at the American College of Rheumatology ("ACR") Annual Meeting. The Company also presented its Phase II data to the U.S. Food and Drug Administration ("FDA") at the end of September. These accomplishments reflect the strength of our team and the potential of our pipeline of innovative diagnostics. Importantly, acceptance into the NIH’s program in addition to a $3 million private placement by a long-term investor provides us with assistance to advance our Rheumatoid Arthritis ("RA") program and product portfolio. I am pleased with our progress and look forward to a strong finish to the year."

Third Quarter 2018 Highlights and Subsequent Events

Closed $3 million private placement with an existing investor

Announced acceptance into the NIH’s Commercialization Accelerator Program for 2018-2019

Presented data on the Manocept platform at the 2018 ACR Annual Meeting

Presented at the 2018 BIO Investor Forum in California

Held meeting with the FDA to discuss the results from the Phase II RA trial and activated macrophage data and next steps for the program

Announced leadership transition in which Dr. Michael Goldberg stepped down as CEO and Board member of Navidea and Mr. Jed Latkin was appointed CEO of Navidea

Held the Annual Shareholder Meeting

Financial Results

Our consolidated balance sheets and statements of operations have been reclassified, as required by current accounting standards, for all periods presented to reflect the line of business sold to Cardinal Health 414, LLC in March 2017 as a discontinued operation. Accordingly, this discussion focuses on describing results of our operations as if we had not operated the discontinued operation during the periods being disclosed.

Total revenues for the third quarter of 2018 were $231,000 compared to $224,000 in the third quarter of 2017. The increase was primarily due to a royalty revenue related to our license agreement with SpePharm in Europe as well as a license revenue for activities related to the sublicense of NAV4694 to Meilleur Technologies, Inc. and the sublicense of Tc99m tilmanocept to Beijing Sinotau Medical Research Co., Ltd. No royalty revenue or license revenue was recognized during the third quarter of 2017. Total revenues for the first nine months of 2018 were $1.1 million compared to $1.4 million for the same period in 2017. Revenue included royalty and license revenue as well as grant revenue, primarily related to SBIR grants from the NIH supporting Manocept development. Other revenue for the first nine months of 2018 was from our marketing partners in Europe and China related to development work performed at their request.

Research and development ("R&D") expenses for the third quarter of 2018 were $1.2 million compared to $875,000 in the third quarter of 2017. R&D expenses for the first nine months of 2018 were $3.4 million compared to $2.8 million during the same period in 2017. The increase was primarily due to net increases in drug project expenses related to increased therapeutics development costs from research consulting, regulatory consulting, and preclinical testing.

Selling, general and administrative ("SG&A") expenses for the third quarter of 2018 were $2.7 million, compared to $1.7 million in the third quarter of 2017. The net increase was primarily due to increased compensation including incentive-based awards as well as termination costs associated with the resignation of our former CEO. SG&A expenses for the first nine months of 2018 were $6.3 million, compared to $9.0 million during the same period in 2017. The net decrease was primarily due to decreased legal and professional services, as well as decreased general office, insurance, depreciation, rent, and travel expenses.

Navidea’s net loss attributable to common stockholders for the quarter ended September 30, 2018 was $3.8 million, or $0.02 per share (basic), compared to a net loss attributable to common stockholders of $1.4 million, or $0.01 per share, for the same period in 2017. Navidea’s net loss attributable to common stockholders for the nine-month period ended September 30, 2018 was $13.0 million, or $0.08 per share (basic), compared to net income attributable to common stockholders of $79.0 million, or $0.49 per share, for the same period in 2017.

Navidea ended the third quarter of 2018 with $6.5 million in cash and investments.

Conference Call Details

Investors and the public are invited to dial into the earnings call through the information listed below. Participants who would like to ask questions during the question and answer session must participate by telephone.

Event:

Third Quarter 2018 Earnings and Business Update Conference Call

Date:

Wednesday, November 7, 2018

Time:

4:30 pm (Eastern Time)

U.S. & Canada Dial-in:

877-407-0312

Conference ID:

13684819

A live audio webcast of the conference call will also be available on the investor relations page of Navidea’s corporate website at www.navidea.com. In addition, the recorded conference call can be replayed and will be available for 90 days following the call on Navidea’s website.

On November 7, 2018 IRX Therapeutics, Inc. reported that the company’s assets have been acquired by the newly formed Brooklyn ImmunoTherapeutics LLC. This name reflects the company’s focus on advancing the science of cytokine-based immunotherapy for the treatment of a range of cancers (Press release, Brooklyn ImmunoTherapeutics, NOV 7, 2018, View Source [SID1234531266]).

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"Cytokine-based immunotherapy overcomes immune suppression to activate an immune attack on tumors by upregulating multiple checkpoints and represents an exciting new approach to treating cancer," said Charles Cherington, General Partner and Board Chair of Brooklyn ImmunoTherapeutics. "In a Phase 2A clinical trial, IRX-2, our clinical drug candidate, demonstrated an improvement in progression free survival and overall survival in patients with head and neck squamous cell carcinoma. We believe this unique injectable cytokine mixture amplified from normal donor lymphocytes has the potential to improve patient outcomes both as a single agent and in combination with other anti-cancer agents. We are committed to exploring this potential in a range of solid tumors including breast cancer, cervical and vulvar neoplasms, renal cell carcinoma, hepatocellular carcinoma, gastric and esophageal cancer as well as other solid tumor indications."

A global, multicenter, randomized, double-blind, placebo-controlled Phase 2B clinical trial of IRX-2 (INSPIRE trial, clinicaltrials.gov NCT02609386) in 105 patients with head and neck squamous cell carcinoma has completed enrollment with results expected in mid-2020 (CIN: NCT03267680, Breast: NCT02950259).