On March 12, 2020 INmune Bio, Inc. (NASDAQ: INMB) (the "Company"), an immunology company developing treatments that harness the patient’s innate immune system to fight disease, reported its financial results for the fourth quarter and full year ended December 31, 2019 and is providing a business update (Press release, INmune Bio, MAR 12, 2020, View Source [SID1234555480]).

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The Company will hold a conference call today at 11AM Eastern (U.S.) time. To participate in the live conference call, please dial 1-877-407-2988 five minutes prior to the scheduled conference call time and ask for the, "INmune Bio Conference Call." International callers should dial 1-201-389-0923. Participants can also use this link for instant telephone access to the event.

2019 and Recent Corporate Highlights on the DN-TNF Platform and NK Priming Platform:

·Closed an initial public offering ("IPO") and commenced trading on The Nasdaq Capital Market.
·Added two new independent members to the board of directors; Ed Baracchini former chief business officer of Xencor, Inc. who has negotiated many transactions with pharmaceutical and biotechnology companies and; Marcia Allen, a fortune 500 executive with vast accounting and finance experience.
DN-TNF Platform Highlights:

·Successfully reported Phase I clinical data that INB03 demonstrates safety and efficacy in cancer patients and has announced that the Phase II program will target trastuzumab resistance in women with HER2+ breast cancer using INB03 as part of combination therapy.
·Awarded a $1,000,000 grant from The Alzheimer’s Association allowing INMB to initiate a Phase 1 clinical trial using XPro1595 to treat patients with Alzheimer’s Disease.
·Awarded a $500,000 grant from The ALS Association to complete IND enabling pre-clinical studies with XPro1595 as a therapy for ALS.
·Initiated a program in NASH with LIVNate the third drug development program from the DN-TNF platform, joining DN-TNF platform drug candidates INB03 and XPro1595.

·XPro1595 had 9 articles published in peer review journals by academic collaborators and INB03 was one of 85 abstracts (out of 885) to be given as an oral presentation at SITC (Free SITC Whitepaper)2019.
·United States Patent and Trademark Office (USPTO) has issued Patent No. 15/776,061 on January 28, 2020, titled "CANCER PREVENTION AND THERAPY BY INHIBITING SOLUBLE TUMOR NUCROSIS FACTOR", which covers INmune’s INB03 Program utilizing dominant negative TNF (DN-TNF) technology for treating cancer.
NK Priming Platform Highlights:

·Announced publication of data on INKmune in Peer-Reviewed Journal PLOS ONE. INKmune is a novel NK cell priming platform that signals the patient’s own NK cells to target residual disease of cancer.
·Finalized and validated manufacturing and distributions processes for INKmune to support up-coming clinical trials.
Professor Lowdell, CSO INmune Bio and Professor of Cell Therapy at UCL, London, and creator of the INKmune product said, "2019 has been a landmark year for this product and is the culmination of 20 years’ of bench-to-bedside research. We have published the molecular basis of the mechanism of action in a peer-reviewed journal, developed scaled manufacture adequate for full commercial delivery and validated an efficient and easily delivered cold supply chain for the drug. I am extremely excited about our delivery of patients into two phase I trials this year in high risk MDS cancer and ovarian cancer, two very different clinical applications."

"2019 and year to date, has been a period of substantial progress," stated RJ Tesi, M.D., Chief Executive Officer of INmune Bio. "We completed our first-in-man study of our DN-TNF platform in cancer and have expanded that franchise to include Alzheimer’s Disease and NASH. Additionally, we just announced pre-clinical proof-of-concept studies in ALS. Both our NK cell priming platform and DN-TNF platform continue to generate data in the laboratory and the clinic to allow us to expand the depth and breadth of our pipeline."

Upcoming Milestones:

·Report results of Phase 1 XPro1595 in Alzheimer’s Disease, expected to complete 2H 2020.
·Enroll first patient in Phase II INB03 program, targeting trastuzumab resistant HER2+ breast cancer using INB03 as part of combination therapy, expected mid-2020.
·Enroll first patient in Phase II LIVNate for NASH, expected mid-2020.
·Enroll first patient in Phase I INKmune in High Risk MDS cancer, expected 2H 2020.
·Enroll first patient in Phase I INKmune in Ovarian cancer, expected 2H 2020.

Financial Results for the Fourth Quarter Ended December 31, 2019:

Net loss attributable to common stockholders for the fourth quarter ended December 31, 2019 was $2.3 million, compared to $1.9 million for the quarter ended December 31, 2018.

Research and development expense totaled approximately $0.9 million for the fourth quarter ended December 31, 2019, compared with approximately $1.0 million for the quarter ended December 31, 2018. The decrease in research and development expense was due to the Company recording $0.3 million of contra research and development expense as a result of the receipt of a grant from the Alzheimer’s Association. Excluding the grant, research and development expense increased during the three months ended December 31, 2019 as a result of the further advancement of our drug platforms.

General and administrative expense was approximately $1.5 million in the quarter ended December 31, 2019, compared to approximately $0.9 million in the quarter ended December 31, 2018. The $0.6 million increase in general and administrative expense is largely due to the costs associated with being a public company and due to higher compensation cost (including higher stock-based compensation).

At December 31, 2019, the Company had cash and cash equivalents of approximately $7.0 million with no debt. During the quarter ending December 31, 2019, the Company received $0.4 million of cash proceeds from Australia and $0.4 million of cash proceeds from the United Kingdom pursuant to research and development tax credits.

As of March 10, 2020, the Company had 10.7 million common shares outstanding.

On March 12, 2020 CymaBay Therapeutics, Inc. (NASDAQ: CBAY), a clinical-stage biopharmaceutical company focused on developing therapies for liver and other chronic diseases with high unmet need, reported corporate updates and financial results for the fourth quarter and fiscal year ended December 31, 2019 (Press release, CymaBay Therapeutics, MAR 12, 2020, View Source [SID1234555479]).

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"Since announcing the decision to halt the development of seladelpar last November, we have been focused on two parallel initiatives: an investigation of the unexpected histologic findings identified by study pathologists in the Phase 2b study of seladelpar in NASH, and an evaluation of strategic alternatives to maximize shareholder value," said Sujal Shah, President and CEO of CymaBay. "Our investigation includes several key activities that will be essential for us to understand the nature and significance of the findings and have the requisite follow-up dialogue with the FDA which we are planning for before the end of the second quarter."

Shah continued, "In parallel to this investigation, our executive team and board have been focused on a comprehensive evaluation of strategic alternatives and cost-cutting initiatives. While we remain committed to completing the investigation, we believe these efforts are prudent in order to make decisions expeditiously once we gain needed clarity on the potential path forward for seladelpar."

Recent Business Highlights

The development of seladelpar was halted in all indications after consulting with expert liver pathologists and hepatologists and in consideration of patient safety. The FDA agreed with this decision, formally placed the seladelpar program on clinical hold for all indications, and subsequently provided input on plans to further investigate the situation. Since then, CymaBay has commenced an in-depth review of the Phase 2b NASH findings. This investigation includes three activities intended to confirm and subsequently understand the significance of the findings identified by study pathologists:
First, a comprehensive collection and review of data including patient demographics, medical history, concomitant medications and a broad set of biochemical markers.
Second, a blinded, independent review of baseline and end of treatment biopsies by several, world-renowned liver pathologists. The independent pathology review will include an accepted pathology scoring framework, known as the Ishak Modified HAI scoring system, to quantitatively characterize features of histology present in our patient population both at baseline and at end-of-treatment. Among these features includes a scoring for the presence and severity of interface hepatitis which is not quantified in the existing framework for scoring NASH pathology.
Third, a formal pathology and clinical hepatology review panel meeting that CymaBay anticipates convening in the middle of the second quarter during which experts will review all information gathered to provide a consensus and independent determination of the role of seladelpar in the Phase 2b NASH findings. This panel will allow for a properly informed dialogue with FDA regarding seladelpar development.

Completed reading of the Phase 2b NASH end-of-treatment biopsies by study pathologists. Preliminary results reported below are for the 152 patients out of the 181 patients enrolled in the study with paired biopsies at entry and end-of-study:
Phase 2b Preliminary Topline Results

Resolution of NASH defined as patients having a NAFLD Activity Score (NAS) of 0 or 1 for lobular inflammation and 0 for hepatocellular ballooning.
Patients that did not have end-of-study biopsies are not included in reported histology endpoints.
Measured changes from baseline to end-of-treatment in liver enzymes including ALT, AST, GGT and ALP, resembled the pattern of meaningful reductions previously reported at week 12.
Implemented cost containment and restructuring program following the decision to place the seladelpar program on hold in order to minimize expenses and conserve capital. As part of this program, CymaBay froze hiring, significantly scaled-back future procurement plans, reduced its work force by more than 60% and scaled down or cancelled many existing contracts for goods and services. The size of the Board of Directors has also been decreased from nine to five seats.

As a result of these actions, CymaBay recorded a $5.1 million restructuring charge during the fourth quarter which includes $2.9 million of employee severance costs, $0.9 million of non-cash stock-based compensation expense associated with the acceleration of stock options of certain terminated employees, and $1.3 million of charges associated with the termination of certain contract manufacturing agreements.

Held $190.9 million in cash, cash equivalents and short-term investments at December 31, 2019.
Fourth Quarter and Year Ended December 31, 2019 Financial Results

Research and development expenses for the three and twelve months ended December 31, 2019 were $20.9 million and $83.8 million, respectively. This compared to R&D expenses of $16.4 million and $58.1 million for the three and twelve months ended December 31, 2018, respectively. Prior to the decision to halt development of seladelpar in November 2019, research and development expenses in the fourth quarter and twelve months ended 2019 were generally higher than in the corresponding periods in 2018 due to expanding clinical trial activities related to the PBC Phase 3 clinical trial, PSC Phase 2 clinical trial, and other NDA-enabling studies.

General and administrative expenses for the three and twelve months ended December 31, 2019 were $4.5 million and $19.2 million, respectively. This compared to $4.2 million and $14.4 million for the three and twelve months ended December 31, 2018, respectively. Prior to the decision to halt development of seladelpar, G&A expenses in the fourth quarter and twelve months ended 2019 were higher than in the corresponding periods in 2018 as a result of higher labor costs and other administrative expenses necessary to support expanding development activities.

Net loss for the three and twelve months ended December 31, 2019 was $29.4 million, or ($0.43) per diluted share, and $102.8 million, or ($1.53) per diluted share, respectively. This compared to net loss of $19.4 million, or ($0.32) per diluted share, and $72.5 million, or ($1.26) per diluted share, in the three and twelve months ended December 31, 2018, respectively. Net loss was higher largely due to increases in operating expenses, including restructuring charges.
Conference Call Details

CymaBay will host a conference call today at 4:30 p.m. ET to discuss fourth quarter and fiscal year end 2019 financial results and provide a business update. To access the live conference call, please dial 855-327-6837 from the U.S. and Canada, or 631-891-4304 internationally, Conference ID# 10008868. To access the live and subsequently archived webcast of the conference call, go to the Investors section of the company’s website at View Source

On March 12, 2020 Tyligand Bioscience, Ltd., a leader in small molecule drug discovery and development, and Context Therapeutics LLC, a clinical stage biopharmaceutical company focused on hormone driven cancers, reported the signing of collaboration agreements for the manufacturing, registration and future commercialization of onapristone extended release (ER) (Press release, Context Therapeutics, MAR 12, 2020, View Source [SID1234555478]).

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Onapristone ER is currently being evaluated in patients with progesterone receptor positive (PR+) rare ovarian and endometrial cancers in the ongoing Phase 2 ONWARD 220 clinical trial. Initiation of additional Phase 2 clinical trials in ER+, PR+, HER2- breast cancer and PR+ endometrial cancers are planned for 2020.

Under the terms of the agreements, Tyligand will be solely responsible for the design and optimization of a novel manufacturing process for onapristone ER to meet Context’s development and future commercialization needs, and standards for quality, safety and cost. Upon completion of specific performance-based milestones, Tyligand will be granted the exclusive right and will be solely responsible for the development and commercialization of onapristone ER in China, Hong Kong and Macau (the "Territory"), and Context will be eligible to receive royalties on net sales of onapristone ER in the Territory. Context will retain rest of world rights to commercialize onapristone ER.

"We are thrilled to partner with Tyligand as we accelerate onapristone ER’s Phase 2 evaluation and prepare for Phase 3," said Martin Lehr, CEO of Context. "Tyligand is renowned for its expertise in process development and has strong networks with manufacturing and clinical capabilities in China and the U.S. Partnering with Tyligand will enable Context to optimize and efficiently scale our manufacturing and clinical capacity to support the evaluation and future commercialization of onapristone ER, our experimental oral therapy, to address the unmet need in treating patients with PR+ cancers."

"Even with the major advances in cancer therapies in recent years, treatment options for patients with hormone driven cancers remain limited," said Tony Zhang, CEO of Tyligand. "Onapristone ER has the potential to be the first-in-class therapeutic agent specifically targeting progesterone receptors and the best-in-class treatment option for breast, endometrial and ovarian cancers. We are proud to partner with Context to develop onapristone ER and make this innovative medicine ultimately more accessible for patients around the world."

About Onapristone ER
Onapristone ER (extended release) is a potent and specific antagonist of the progesterone receptor that is orally administered. Currently, there are no approved therapies that selectively target progesterone receptor positive (PR+) cancers. Preclinical and clinical data suggest that onapristone ER has anticancer activity by inhibiting progesterone receptor binding to chromatin, downregulating cancer stem cell mobilization and blocking immune evasion. Onapristone ER is currently being evaluated in patients with PR+ rare ovarian and endometrial cancers in the ongoing Phase 2 ONWARD 220 clinical trial. Additional Phase 2 clinical trials in ER+, PR+, HER2- breast cancer and PR+ endometrial cancers will be initiated in 2020. Onapristone ER is an investigational drug that has not been approved for marketing by any regulatory authority.

On March 12, 2020 Harbour BioMed (HBM) reported successful completion of its Series B+ round financing of $75 million to accelerate the advancement of its clinical-stage compounds and growing portfolio of next generation biotherapeutics for treating cancer and immunological diseases (Press release, Harbour BioMed, MAR 12, 2020, View Source [SID1234555477]). New investors participating in the financing – SK Holdings, Greater Bay Area Fund, Efung Capital, Zheshang Venture Capital and Zhejiang University Future Capital and JT New Century – joined existing investors, including Legend Capital, AdvanTech and GIC Pvt. Ltd. The company previously completed an $85 million Series B financing in August 2018.

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The funds from the Series B+ will help drive these programs towards key clinical and development milestones. This round of financing further underscores both company’s existing and new investors’ confidence in HBM, and the team’s ability to execute with conviction and commitment.

"Over the past several months, HBM has made great progress in advancing two leading assets towards mid-late stage clinical trials in China, and we began international clinical studies with our first internally-discovered biotherapeutic, a next generation, fully-human anti-CTLA-4 antibody (HBM4003) for the treatment of advanced solid tumors," said Dr. Jingsong Wang, Founder, Chairman and CEO of Harbour BioMed. "Our discovery efforts have also been extremely productive, both internally and in collaboration with leading organizations around the world. In addition to HBM4003, our innovative discovery platform HBICETM has rapidly generated a robust portfolio of differentiated, fully human antibodies, including next generation bi-and multi-specifics. More recently, we have leveraged the power of our antibody discovery platform in select other areas of great unmet medical needs, such as in coronavirus disease (COVID-19), where we have entered a collaboration with Mount Sinai Heath System in New York".

The Company recently reported on major progress in its clinical development programs, including:

· Start of Phase 1 clinical studies with HBM4003 for the treatment of advanced solid tumors. HBM4003, a next generation anti-CTLA 4 therapeutic, is the first fully human antibody based on HBM’s heavy chain only (HCAb) antibody discovery technology. The trial, underway in Australia, is the first in an international development program that will inaugurate trials in the US, EU and China. HBM recently received IND approval from the FDA to initiate its trial in the US. HBM4003 has shown potential in preclinical studies for increased anti-tumor activity based on enhanced antibody dependent cell toxicity mediated Treg depletion and a favorable safety profile.

· Start of Phase 2/3 clinical trials of HBM 9161, an anti-FcRn antibody, for the treatment of multiple severe, autoimmune diseases including myasthenia gravis, adult immune thrombocytopenia, Graves’ ophthalmology and other related indications. Phase 2/3 studies for several of these indications are expected to begin in the first half of 2020 in Greater China.

· Successful completion of a Phase 2 trial of HBM 9036 for Dry Eye Disease. HBM is preparing to start a Phase 3 registration trial in Q2 2020 in China.

· Start of Phase 2 clinical trials of HBM9167, its humanized IgG1 monoclonal antibody targeting programmed death-ligand 1 (PD-L1), for the treatment of nasopharyngeal cancer (NPC). The US FDA granted HBM9167 Orphan Drug Designation (ODD) for the development in treating NPC.

HBM has built a powerful drug discovery engine based on its patented HCAb platform for generating novel, fully human heavy chain only antibodies, including bi- and multi-specifics. The technology is integrated with other advanced approaches – e.g., single cell analysis and deep profiling— to dramatically reduce the time to candidate selection from months to days.

On March 12, 2020 EXUMA Biotech Corp. (formerly F1 Oncology), a clinical-stage biotechnology company discovering and developing CAR-T therapies for solid and liquid tumors, reported a $19M Series B round of financing that includes new investments by MSD Partners and F1 BioVentures, as well as conversion of notes held by individual investors (Press release, EXUMA Biotechnology, MAR 12, 2020, View Source [SID1234555463]).

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EXUMA Biotech Corp. and its affiliates will be utilizing these proceeds to advance new logic gated CAR-T therapies for solid tumor malignancies as well as for further development and partnering of its rapid point-of-care (or "rPOC"), same-day CAR-T platform technology.

Additionally, the company has now aligned management with its international subsidiaries under one cohesive global organization (www.exumabio.com), to better reflect its new business model. "We are now moving forward together as one company. The timing was right for us to create a unified global platform to leverage our synergistic capabilities, which we believe will ultimately allow us to produce and deliver CAR-T products even more efficiently for the millions of people worldwide in need of cutting-edge treatments in their fight against cancer," said Gregory Frost, Ph.D., Chairman and CEO of EXUMA Biotech Corp.

The name change coincides with the addition of two new directors, Scott Segal and Frank McCormick, who join existing directors David Ramsay and Gregory Frost. "We are pleased to welcome these new Directors to the EXUMA board; their collective experience will be invaluable as we advance through several key inflection points in 2020," said Dr. Frost. "This will be a tremendous year for the company as we continue development of these exciting new platforms, especially rPOC, which can help make cellular therapies more readily accessible to patients around the world."

Scott Segal is a Managing Director at MSD Partners ("MSD"), where he invests across a range of sectors, in both debt and structured equity. He joined MSD in 2006 from the Boston Consulting Group, where he provided consulting services to Fortune 500 executives. Prior to the Boston Consulting Group, Mr. Segal worked at HarbourVest Partners and Salomon Brothers.

Frank McCormick, Ph.D., F.R.S., D.Sc. (Hon) currently serves as a Professor at the UCSF Helen Diller Family Comprehensive Cancer Center. Prior to this, Dr. McCormick pursued cancer-related work and held positions with several Bay area biotechnology firms, including Cetus and Chiron Corporations. In 1992, he founded Onyx Pharmaceutics, where as CSO he initiated drug discovery efforts that led to the approval of Sorafenib in 2005 for treatment of renal cell cancer, and for liver cancer in 2007. Currently, he leads the NCI’s Ras Initiative, where he oversees developmental therapies against Ras-driven cancers, which include many pancreatic, colorectal, and lung cancers. Dr. McCormick is the author of over 300 scientific publications.