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).

On November 7, 2018 SpringWorks Therapeutics, a clinical-stage biopharmaceutical company focused on developing life-changing medicines for patients with severe rare diseases and cancer, reported that the U.S. Food and Drug Administration (FDA) has granted Fast Track designation for nirogacestat, an investigational, oral, small molecule, selective gamma-secretase inhibitor, for the treatment of adult patients with progressive, unresectable, recurrent or refractory desmoid tumors or deep fibromatosis (Press release, SpringWorks Therapeutics, NOV 7, 2018, View Source [SID1234538851]).

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Desmoid tumors are rare and debilitating soft-tissue tumors that can occur in both children and adults. Depending on their size and location, desmoid tumors can cause severe morbidities such as pain, internal bleeding, disfigurement, and limited range-of-motion. In some cases, desmoid tumors can be fatal if they impact vital organs.1 It is estimated that 900 to 1,500 new cases of desmoid tumors are diagnosed each year in the United States.2

"The Fast Track designation recognizes that desmoid tumors have a substantial impact on the lives of patients, and that nirogacestat has the potential to address the significant needs faced by this community who currently do not have an FDA-approved treatment," said Saqib Islam, Chief Executive Officer of SpringWorks Therapeutics. "We look forward to continuing to work closely with the FDA throughout our development program with the hope of ultimately bringing this important medicine to patients."

The FDA’s Fast Track program is designed to expedite the development and review of drugs with the potential to treat serious or life-threatening conditions, and with nonclinical or clinical data that demonstrate the potential to address unmet medical needs. Fast Track designation enables a company to have frequent communication with the FDA throughout the drug development and review process.3

In June 2018, the U.S. FDA granted Orphan Drug designation for nirogacestat for the treatment of desmoid tumors. SpringWorks expects to initiate the DeFi Study, a global Phase 3, double-blind, randomized, placebo-controlled, trial in patients with desmoid tumors in the first half of 2019.

About Desmoid Tumors
Desmoid tumors (also referred to as aggressive fibromatosis or desmoid-type fibromatosis) are rare, non-metastatic tumors of connective tissue cells that can arise in any part of the body, with the most common sites being the upper and lower extremities, abdominal walls, thoracic areas, and the head and neck. The severity of desmoid tumors and associated symptoms varies based on their size and location. Desmoid tumors can cause severe morbidities such as pain, internal bleeding, disfigurement, limited range of motion, and in some cases, fatality if they impact vital organs. While they can affect children and adults, desmoid tumors are more commonly diagnosed in young adults between 20-30 years of age, with a two-to-three-fold predominance in females. 1,4 It is estimated that desmoid tumors affect 2 to 4 per million people worldwide, and that there are 900 to 1,500 new cases diagnosed per year in the United States.2 Historically, desmoid tumors were treated with surgical resection or in severe cases, amputation, but even with these interventions, high rates of tumor regrowth have been observed.5 There are currently no FDA-approved therapies for the treatment of desmoid tumors.

About Nirogacestat
Nirogacestat is an investigational, oral, small molecule, selective gamma-secretase inhibitor. Gamma secretase is an integral membrane protein that cleaves multiple different transmembrane protein complexes, including Notch, which is believed to play a role in activating pathways that contribute to desmoid tumor growth. Nirogacestat has been investigated in 24 patients with desmoid tumors across Phase 1 and Phase 2 clinical trials.

On November 7, 2018 Evotec AG (Frankfurt Stock Exchange: EVT, MDAX/TecDAX, ISIN: DE0005664809) reported that it will report its financial results for the first nine months of 2018 on Tuesday, 13 November 2018 (Press release, Evotec, NOV 7, 2018, View Source;announcements/press-releases/p/evotec-ag-to-report-first-nine-month-2018-results-on-13-november-2018-5741 [SID1234530884]).

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The Company is going to hold a conference call to discuss the results as well as to provide an update on its performance. The conference call will be held in English.

Conference call details

Date: Tuesday, 13 November 2018

Time: 02.00 pm CET (08.00 am EST, 01.00 pm GMT)

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From France: +33 170 709 502

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