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IMMUNOMEDICS AND EVEREST MEDICINES ANNOUNCE EXCLUSIVE LICENSE AGREEMENT FOR SACITUZUMAB GOVITECAN IN EAST AND SOUTHEAST ASIA EXCLUDING JAPAN

On April 29, 2019 Immunomedics, Inc., (NASDAQ: IMMU) ("Immunomedics" or the "Company"), a leading biopharmaceutical company in the area of antibody-drug conjugates (ADC) and Everest Medicines II Limited ("Everest Medicines"), a C-Bridge Capital-backed biopharmaceutical company, reported an exclusive license agreement to develop, register, and commercialize sacituzumab govitecan in Greater China, South Korea and certain Southeast Asian countries (Territory) (Press release, Immunomedics, APR 29, 2019, View Source [SID1234535687]).

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"We are pleased to be partnering with Everest Medicines to commercialize sacituzumab govitecan in the Asian market outside Japan and further develop the product in solid tumor indications of high unmet need in the territory," said Usama Malik, Chief Financial Officer and Chief Business Officer of Immunomedics. "This agreement sets a new benchmark for a single-asset licensing deal for regional China and exemplifies our commitment to expand the geographic footprint and clinical use of sacituzumab govitecan for the benefit of cancer patients worldwide."

"Sacituzumab govitecan is an innovative and unique ADC with a highly favorable clinical benefit rate across solid tumors and provides us the opportunity to address hard to treat cancers in key underserved regions across Asia. We look forward to partnering with Immunomedics’ clinical and regulatory teams to accelerate the development of sacituzumab govitecan across multiple indications in Greater China where there is great need for innovative cancer therapeutics of major impact," said Eric Rowinsky, M.D., U.S. Chief Medical Officer for Oncology, and Yang Shi, M.D., China Chief Medical Officer for Oncology of Everest Medicines.

Immunomedics will receive an upfront payment of $65 million and an additional $60 million based on U.S. FDA approval of sacituzumab govitecan in metastatic triple-negative breast cancer. Everest will develop and commercialize the product in various global and local indications across the Territory. The Company is eligible to receive development and sales milestone payments of up to $710 million, as well as escalating tiered royalties that begin in the mid-teens based on net sales within the Territory.

Pursuant to the agreement, Everest Medicines will be responsible for all costs associated with the clinical development and commercialization of sacituzumab govitecan in the Territory, while a Joint Steering Committee will be established between the companies to oversee the overall strategy and priorities.

"This transformative deal reinforces Everest Medicines’ position as the preeminent biopharmaceutical company to develop and commercialize globally innovative products in Greater China and other emerging Asia Pacific markets," said Ian Woo, President and Chief Financial Officer of Everest Medicines.

"Everest Medicines’ highly experienced team has a proven track record of delivering industry leading execution and we look forward to leveraging our deep knowledge and cumulative insights to address diseases with unmet need that are highly prevalent in these underserved regions," said Sean Cao, Interim CEO of Everest Medicines.

"Today’s announcement culminates a thoughtful and deliberate process, that expedites regional expansion of our lead product candidate in the world’s fastest growing pharmaceutical market and significantly enhances shareholder value. This partnership allows the Company to continue on its path to becoming a global biopharmaceutical company, and importantly maintaining the strategic optionality in core established markets worldwide," said Behzad Aghazadeh, Chairman of the Board of Directors of Immunomedics.

About Sacituzumab Govitecan

Sacituzumab govitecan, Immunomedics’ most advanced product candidate, is a novel, first-in-class antibody-drug conjugate targeting the Trop-2 receptor expressed by many solid cancers and delivering the moderately-toxic drug, SN-38, directly to the tumor. Sacituzumab govitecan has received Breakthrough Therapy Designation from the U.S. Food and Drug Administration for the treatment of patients with metastatic triple-negative breast cancer who have received two prior therapies for metastatic disease.

Nicox to Present at Upcoming Pharmaceutical Industry and Financial Events

On April 29, 2019 Nicox SA (Euronext Paris: FR0013018124, COX), an international ophthalmology company, reported that it will be presenting at the following pharmaceutical industry and financial events in Q2 2019 (Press release, NicOx, APR 29, 2019, View Source [SID1234535676]):

Michele Garufi, Chairman and CEO, will present at the 2019 Ophthalmology Innovation Summit (OIS) on May 2, 2019, prior to the 2019 American Society of Cataract and Refractive Surgery (ASCRS) Annual Meeting. The conference is being held at the Hilton San Diego Bayfront in San Diego, U.S.
Gavin Spencer, Chief Business Officer, will present at the JMP Securities Life Sciences Conference on June 20, 2019 to be held at the St. Regis hotel in New York, U.S.
Emmet Purtill, Senior Director of Business Development, will present at the BIO 2019 International Convention to be held from June 3-6, 2019 in Philadelphia, U.S.

The presentations will be available on the Nicox website (www.nicox.com) in the "Presentations & Events" section.

Nicox management will also participate in the following events for 1:1 meetings with investors:

May 16: European MidCap Event, Copenhagen, Denmark
June 18-19: European MidCap Event, Paris, France
June 24-25: HealthTech Investor Day, Paris, France

Forbius’ AVID200, a Novel TGF-beta 1 & 3 Inhibitor, Cleared by Health Canada to Commence Phase 1 Clinical Trial in Solid Tumors

On April 29, 2019 Forbius, a clinical-stage company that develops novel biologics for the treatment of cancer and fibrosis, announced that it has received a no objection letter from Health Canada for its clinical trial application (CTA) to conduct a Phase 1 trial in solid tumors with immuno-oncology candidate AVID200, a rationally designed and highly potent inhibitor of TGF-beta 1 & 3 (Press release, Forbius, APR 29, 2019, View Source [SID1234535642]).

AVID200-03 (NCT03834662) is a Phase I, open label, dose-escalation trial to establish the recommended phase 2 dose (RP2D) of AVID200 in patients with advanced or metastatic malignancies. The trial is currently enrolling patients at centers in the U.S. and will now be expanded to additional clinical sites in Canada to recruit a total of up to 36 patients.

TGF-beta 1 & 3 are the main oncogenic TGF-beta isoforms expressed by many solid tumors and represent promising immuno-oncology targets. These TGF-beta isoforms are implicated in T-cell suppression, fibrosis in the tumor microenvironment, and resistance to immunotherapeutics such as nivolumab (Opdivo) and pembrolizumab (Keytruda) (Chakravarthy et al., Nature Comm., 2018; Tauriello et al., Nature, 2018; Mariathasan et al., Nature, 2018).

About AVID200 and the AVID200-03 Trial
AVID200 is an isoform-selective and highly potent inhibitor of TGF-beta 1 & 3 undergoing Phase 1 clinical testing in solid tumors and fibrotic diseases. TGF-beta 1 & 3 are the principal disease-driving isoforms, while TGF-beta 2 is responsible for normal cardiac function and hematopoiesis.

AVID200’s selectivity for TGF-beta 1 & 3 was designed to achieve optimal efficacy while circumventing cardiac and other safety issues that have limited the applicability of older-generation, non-selective TGF-beta inhibitors. Therefore, AVID200 is positioned to be an effective and well-tolerated therapeutic in a variety of clinical settings, including in combination with anti-PD-(L)1 therapy.

AVID200-03 (NCT03834662) is an open label, multicenter, dose-escalation study to evaluate the safety, pharmacokinetics, pharmacodynamics, and antitumor effects of AVID200 in patients with advanced or metastatic solid tumor malignancies.

Teneobio Announces US FDA Approval of the Investigational New Drug Application for TNB-383B and the Initiation of Phase I Clinical Studies in Multiple Myeloma Patients

On April 29, 2019 Teneobio, Inc. and its affiliate TeneoOne, Inc. reported that their investigational new drug application (IND) for TNB-383B, a bispecific T-cell engaging antibody for the treatment of multiple myeloma, was cleared for the initiation of Phase I clinical studies by the US Food and Drug Administration (FDA) on April 24th, 2019 (Press release, TeneoBio, APR 29, 2019, View Source [SID1234535622]). The ongoing development of TNB-383B is being pursued in collaboration with AbbVie, Inc.

TNB-383B is a fully human bispecific antibody with two binding moieties for B-Cell Maturation Antigen (BCMA) on one arm and a unique anti-CD3 on the other. In preclinical studies, TNB-383B induced T-cell dependent killing of myeloma cells (which express BCMA) but with reduced cytokine secretion, a feature that could limit immune mediated toxicities while retaining cytotoxic activity.

Roland Buelow, CEO of Teneobio, Inc. added "We are looking forward to starting clinical studies with TNB-383B. We believe that Teneobio’s differentiated anti-BCMAxCD3 (TNB-383B), which incorporates a unique T-cell activation anti-CD3, will provide a better therapeutic window for the treatment of multiple myeloma than current BCMA-targeting bispecific antibodies in the clinic. Our T-cell redirecting anti-CD3 platform is also the foundation for additional therapeutics that we are rapidly advancing in our pipeline. These include TNB-486 (anti-CD19xCD3) and TNB-585 (anti-PSMAxCD3) for the treatments of lymphoma and prostate cancer, respectively. We look forward to filing INDs on these additional programs in H2 of 2020."

Precision BioSciences Reports First Quarter 2019 Financial Results

On April 29, 2019 Precision BioSciences, a genome editing company dedicated to improving life (Nasdaq: DTIL) ("Precision") through the application of its proprietary ARCUS genome editing platform, reported financial and corporate results for the first quarter 2019 and provided an overview of recent accomplishments and upcoming events (Press release, Precision Biosciences, APR 29, 2019, View Source [SID1234535619]).

Key Highlights and Recent Developments

Executed private financing and initial public offering (IPO) on Nasdaq for combined net proceeds to Precision of over $170 million

Bolstered Board of Directors with addition of Raymond Schinazi, PhD

Initiated patient dosing for Phase 1/2a clinical trial of off-the-shelf CAR T cell therapy

"The first quarter was truly transformative for Precision BioSciences, as we completed our successful initial public offering, further strengthening our ability to deliver on the promise of ARCUS genome editing," said Matt Kane, Chief Executive Officer and co-founder. "Since the completion of our IPO, we have transitioned to a clinical stage company with the dosing of the first patient in a Phase 1/2a clinical trial of our lead allogeneic CAR T therapy, targeting CD19 for the treatment of non-Hodgkin lymphoma and acute lymphoblastic leukemia. We believe our team and technology have the potential to bring meaningful benefits to the lives of many."

On March 27th, the Company priced the initial public offering of its common stock, which was underwritten by J.P Morgan, Goldman Sachs & Co. LLC, Jefferies and Barclays who served as joint book-running managers for the offering. The IPO closed on April 1, 2019 with gross proceeds to Precision of $145.3 million before underwriting discounts, commissions and offering costs. Precision issued 9,085,000 shares of common stock, inclusive of the underwriters’ overallotment option, at an offering price of $16.00 per share. The IPO was preceded by a private convertible financing of approximately $40 million. Following the closing of the IPO, Precision had approximately 50.4 million shares of common stock outstanding, including shares of preferred stock and convertible promissory notes that converted into common stock.

Earlier in the quarter, on March 14th, the Company appointed Raymond Schinazi, PhD, Hon DSc to its board of directors. Dr. Schinazi is the Frances Winship Walters Professor of Pediatrics and director of the Laboratory of Biochemical Pharmacology at Emory University. A world leader in nucleoside chemistry, he is best known for his pioneering work on HIV, HBV, and HCV drugs d4T (stavudine, Zerit), 3TC (lamivudine, Epivir), FTC (emtricitabine, Emtriva), LdT (telbivudine, Tyzeka), and sofosbuvir (Sovaldi), which are all approved by the US FDA and the EMEA. More than 94% of HIV-infected individuals in the US on combination therapy take at least one of the drugs he invented, and he has founded or co-founded several pharmaceutical companies, including Triangle Pharmaceuticals, Idenix Pharmaceuticals, and Pharmasset, Inc.

Recently, on April 17th, Precision initiated patient dosing in the Phase 1/2a clinical trial of an allogeneic CAR T cell therapy program, PBCAR0191, which is being evaluated in adult patients with relapsed or refractory (R/R) non-Hodgkin lymphoma (NHL) or R/R B-cell precursor acute lymphoblastic leukemia (B-ALL) as an off-the-shelf CAR T cell therapy. Precision believes this is the first U.S.-based clinical trial to

evaluate an allogeneic CAR T cell therapy for NHL. PBCAR0191 is made from donor-derived T cells that are modified using Precision’s ARCUS genome editing technology. These edits are designed to generate CAR T cells that specifically recognize CD19, an important target in several B-cell cancers, and to prevent graft-versus-host disease, a significant complication associated with existing donor-derived cell-based therapies.

Upcoming Events

22nd Annual Meeting of the American Society of Gene & Cell Therapy (ASGCT) (Free ASGCT Whitepaper), April 29 – May 2, 2019

Jefferies U.S. Healthcare Conference, June 4 – 7, 2019

Goldman Sachs 40th Annual Global Healthcare Conference, June 11 – 13, 2019

Raymond James Life Sciences & MedTech Conference, Jun 18 – 19, 2019

First Quarter 2019 Financial Results

Revenues: Total revenues for the quarter ended March 31, 2019 were $5.5 million, compared to $1.5 million for the quarter ended March 31, 2018. This increase was primarily related to research funding from our joint development collaboration partners.

Research and Development Expenses: Research and development expenses were $19.9 million for the first quarter of 2019, as compared to $8.1 million for the same period in 2018. This increase of $11.8 million was primarily due to increases in direct research and development expenses including contract manufacturing costs, as well as an increase in personnel costs and expenses to support our technology platform development and manufacturing capabilities.

General and Administrative Expenses: General and administrative expenses were $5.0 million for the first quarter of 2019, as compared to $2.6 million for the same period in 2018. The increase of $2.4 million was primarily due to additional personnel and facility costs associated with our growing infrastructure needs.

Net Loss: Net loss was $31.8 million, or $1.99 per share, for the first quarter of 2019, compared to a net loss of $9.0 million, or $0.57 per share, for the same period in 2018.

Cash and Cash Equivalents: As of March 31, 2019, Precision had approximately $116.5 million in cash and cash equivalents, including proceeds of approximately $40 million from a private convertible financing and excluding the net proceeds of $130.9 million from Precision’s IPO. Precision expects that existing cash and cash equivalents, together with the net proceeds from the IPO, will be sufficient to fund its operating expenses and capital expenditure requirements through 2020.