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)

From Germany: +49 69 20 17 44 220

From France: +33 170 709 502

From Italy: +39 023 600 6663

From UK: +44 20 3009 2470

From USA: +1 877 423 0830

Access Code: 17611831#

On November 7, 2018 Onconova Therapeutics, Inc. (NASDAQ:ONTX), a Phase 3-stage biopharmaceutical company focused on discovering and developing novel products to treat cancer, with a primary focus on myelodysplastic syndromes (MDS), reported the appointment of Dr. Richard "Ric" Woodman as Chief Medical Officer and Senior Vice President of Research & Development. Dr. Woodman will report to Dr. Steve Fruchtman, President and former CMO of the Company (Press release, Onconova, NOV 7, 2018, View Source [SID1234530908]).

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Ric Woodman, M.D., served most recently as Senior Vice President and Head of U.S. Oncology Clinical Development and Medical Affairs for Novartis. In his role, Ric provided strategic medical and scientific leadership for both marketed and development-stage compounds. Previously, Ric served as Franchise Head for Hematology in Global Medical Affairs at Novartis Oncology with global oversight of non-registration clinical programs and has worked on the development and life-cycle management of several compounds including Tasigna, Glivec, Farydak, Rydapt, Odomzo and Kymriah.

Before joining Novartis Oncology, Dr. Woodman was Senior Medical Director with Johnson & Johnson, leading the Oncology franchise at Ortho Biotech Products, LP. Prior to Ortho Biotech, Ric held academic appointments as Professor in the Departments of Medicine and Oncology at the University of Calgary in Canada where he joined the faculty in 1990.

Dr. Woodman completed his hematology/oncology clinical fellowship and postdoctoral research fellowship at Scripps Clinic and Research Institute in the Department of Experimental Medicine.

In his welcome statement, Dr. Steve Fruchtman said, "The addition of Ric to the Onconova leadership team is an exciting boost to our expertise in drug development in malignant hematology and oncology. Ric has a proven track record and expertise in the approval of novel agents that have changed the standard of care in hematology, including an erythropoietic stimulatory agent to promote red cell production by the marrow, a common issue in patients with MDS, as well as agents for CML that have transformed the life expectancy of these patients and the management of CML from a previously lethal disease to a chronic disorder. As a key part of the team, Ric’s expertise will help optimize the development of Rigosertib for patients with unmet medical needs in MDS and cancer."

"I am excited to join Onconova at this advanced stage of development of Rigosertib and other promising pipeline assets," said Dr. Woodman. "The anticipated completion of the INSPIRE trial in higher-risk MDS and advancing the design of a pivotal combination trial of oral rigosertib and azacitidine towards a Special Protocol Assessment (SPA) are positioning the Company for late stage development, which are areas within my experience and expertise. These trials have set a solid foundation for Rigosertib in patients with MDS. While focused on advancing Rigosertib towards regulatory approval for MDS, Onconova has also created additional opportunities for advancement. I am delighted to join my new colleagues at Onconova, and have the opportunity to work with Steve again in advancing new medicines for patients with unmet medical needs."

Onconova is also pleased to announce the hiring of Matthew Parris to the position of Senior Director, Clinical Operations. Matt joined us after leadership roles in Europe and the U.S. at several Biotechnology companies, including, most recently, Inovio, and at Clinical Research Organizations (CROs), including Orion and Pharm-Olam.
Onconova also welcomes David Evans, who joined recently as Associate Director, Regulatory Affairs, after a decade-long successful career at Celgene.