On March 5, 2020 INmune Bio, Inc., an immunology company developing treatments that harness the patient’s innate immune system to fight disease, reported that management will present at the 32nd Annual Roth Conference at 8:30 a.m. (PT) on Tuesday, March 17, 2020 and will conduct one-on-one meetings that day (Press release, INmune Bio, MAR 5, 2020, View Source [SID1234555321]).

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The conference will be held March 15-17, 2020 at The Ritz Carlton, Laguna Niguel in Orange County, CA. The ROTH Conference, with close to 550 participating companies and over 5,100 attendees, will feature presentations from public and private companies in a variety of sectors.

Management will be available for one-on-one meetings. For more information about the conference or to schedule a one-on-one meeting with management, please contact [email protected].

On March 5, 2020, XOMA (US) LLC (the "Company" or "XOMA"), a wholly-owned subsidiary of XOMA Corporation, reported that it has entered into a Collaboration and License Agreement (the "Agreement") with Cadila Healthcare Limited ("Zydus"), a company organized and existing under the laws of India, effective as of March 3, 2020 (Filing, 8-K, Xoma, MAR 5, 2020, View Source [SID1234555316]). Pursuant to the Agreement, the Company acquired the rights to receive potential royalty payments in the single to low double-digit percentages of the aggregate net sales in India, Brazil, Mexico and certain other emerging markets (the "Zydus Territory") associated with an IL-2-based immuno-oncology drug candidate that combines Zydus’s IL-2 candidate with XOMA’s anti-IL-2 monoclonal antibody (the "Drug Candidate"). Pursuant to the Agreement, Zydus will make certain development, regulatory and commercial milestone payments to the Company in the potential aggregate amount of up to $24 million upon the occurrence of certain events as set forth in the Agreement and share with the Company revenue received from third party sublicensees in the Zydus Territory. Zydus will be solely responsible for the development of the Drug Candidate through the first Phase 2 clinical study at its sole cost.

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Subject to a right of first negotiation granted to Zydus to acquire rights to the Drug Candidate world-wide outside of the Zydus Territory (the "XOMA Territory"), which expires 180 days following the completion of the Drug Candidate’s first Phase 2 clinical study, the Company retains the rights to develop and commercialize the Drug Candidate in the XOMA Territory itself or through one or more third party sublicensees. The Company’s development and commercialization of the Drug Candidate in the XOMA Territory would be subject to the payment of low to mid teen-digit royalties to Zydus on the aggregate net sales of the Drug Candidate, or sharing with Zydus revenue received from third party sublicensees.

Unless earlier terminated, the Agreement will remain in effect until the expiration of all payment obligations by either party with respect to the Drug Candidate. The Agreement may be terminated (i) by mutual agreement, (ii) by either party for the other party’s uncured material breach, bankruptcy or competitive change of control, (iii) by Zydus prior to expiration of its right of first negotiation due to safety or technical infeasibility or (iv) by Zydus following expiration of its right of first negotiation for convenience upon 90 days prior notice if prior to the first commercial sale of the Drug Candidate in the Zydus Territory or upon 180 days prior notice if after such first commercial sale.

The description of the Agreement contained herein does not purport to be complete, and is qualified in its entirety by reference to such Agreement, together with the exhibits thereto, a copy of which will be filed as an exhibit to the Company’s Quarterly Report on Form 10-Q for the period ending March 31, 2020.

On March 5, 2020, Celsion Corporation (the "Company") reported to Aspire Capital Fund, LLC, an Illinois limited liability company ("Aspire Capital"), terminating the Common Stock Purchase Agreement dated October 28, 2019 (the "2019 Aspire Purchase Agreement") with Aspire Capital effective as of March 6, 2020. The 2019 Aspire Purchase Agreement provided that, upon the terms and subject to the conditions and limitations set forth therein, Aspire Capital was committed to purchase up to an aggregate of $10 million of shares of the Company’s common stock over the 24-month term of the 2019 Aspire Purchase Agreement at a price equal to (i) the lowest sale price of the Company’s common stock on the purchase date; or (ii) the arithmetic average of the three (3) lowest closing sale prices for the Company’s common stock during the ten (10) consecutive trading days ending on the trading day immediately preceding the purchase date (Filing, 8-K, Celsion, MAR 5, 2020, View Source [SID1234555303]). In consideration for entering into the 2019 Aspire Purchase Agreement, the Company issued to Aspire Capital 100,000 shares of the Company’s common stock.

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On November 8, 2019, the Company filed with the SEC a Registration Statement on Form S-1 registering all the shares of common stock that may be offered to Aspire Capital from time to time under the 2019 Aspire Purchase Agreement. From October 28, 2019 through the date of termination, the Company sold 1,500,000 shares of common stock under the 2019 Aspire Purchase Agreement generating proceeds of $2.3 million. Upon termination, the Company has no further obligations under the 2019 Aspire Purchase Agreement.

On March 5, 2020 City of Hope reported that $12 million federal grant enabled and collaborators to deploy a novel cloud-computing platform, making an immense amount of data from a historic 25-year study more accessible and user-friendly (Press release, City of Hope, MAR 5, 2020, View Source [SID1234555292]).

The ongoing California Teachers Study that first began in 1995 has already given researchers a bevy of data on how to better prevent and treat cancers, heart conditions and Alzheimer’s disease. In the past, this data was available only to a select few researchers. Opening the data to researchers worldwide and making it user-friendly will fast-track scientific discoveries that can improve the quality of life for people around the world, said James Lacey Jr., Ph.D., M.P.H., director of the Division of Health Analytics at City of Hope and one of the principal investigators of the study.

"We might be one of the first in the world to use secure cloud computing to build a data commons for an observational study," Lacey said, adding that observational studies are expensive, so synthesizing data from disparate sources and making the information widely available is one way to ensure that federal grant dollars "get more mileage."

"City of Hope continues to lead the health provider pack when it comes to collaborating with cutting-edge technology companies to deploy solutions that accelerate the translation of precision medicine into disease prevention and, potentially, therapies for patients," Lacey said. Precision medicine is a personalized approach to disease prevention and treatment that takes into account each person’s specific genes, environment and lifestyle choices.

The study, published on Feb. 12 in the journal Cancer Epidemiology, Biomarkers and Prevention, provides a roadmap for other population health experts who want to broaden the reach and potential impact of their own research. The novel open cloud-computing platform City of Hope, San Diego Supercomputer Center (SDSC) and UC San Diego created for the California Teachers Study has simplified the process for understanding the incidence and distribution of disease. As a result, scientists can more quickly detect patterns and trends that could be translated into better health for individuals and the public.

The California Teachers Study was created in 1995 and enrolled 133,479 current and former public-school teachers or administrators. They agreed to have their health and lifestyle tracked to help understand why teachers historically have higher rates of breast cancer. The study has since expanded to address other cancers including colon, pancreatic and bladder, as well as heart disease and even Parkinson’s and Alzheimer’s disease. More than 190 published studies have resulted from the data.

This is an example of how sharing is really caring, Lacey said. "Cancer, heart disease and Alzheimer’s disease are big problems that need the combined brainpower of the brightest minds around the world. Cloud computing directly helps cancer researchers store, share, analyze and use their data in new and more efficient ways. In short, our open website allows interested individuals to securely access, explore and generate discoveries with our California Teachers Study data."

The new platform shortens the time needed to launch a research project from weeks to days, Lacey said. Previously, every research project had to be custom built, but now with the data commons framework, users can get started quickly, apply workflow templates for their projects and start analyzing the data right away.

"It is gratifying to see the grant for the California Teachers Study infrastructure successfully deliver on its promise of building a secure, cloud-based data commons platform for the cancer epidemiology research community," said Sandeep Chandra, director of SDSC’s Sherlock Division and senior author of the study. "What is more exciting is the potential of how this data commons can serve as a model for other current, and future, observational studies through adoption of this framework; thereby, reducing time and investment to deploy data management and analysis capabilities."

Elena Martinez, Ph.D., professor in the Department of Family Medicine and Public Health at UC San Diego and one of the principal investigators of the study added, "The newly implemented California Teachers Study infrastructure exemplifies what is possible when leveraging the knowledge and experience of population scientists who work alongside data scientists to move research into the 21st century. I am proud to be a part of an innovation leader that will serve as a model for future observational studies."

The University of California, San Francisco, also contributed to the creation of the open platform. The study was supported by the National Cancer Institute of the National Institutes of Health (CA199277).

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On March 5, 2020 Kadmon Holdings, Inc. (NYSE: KDMN) reported financial and operational results for the fourth quarter and full year ended December 31, 2019 (Press release, Kadmon, MAR 5, 2020, View Source [SID1234555279]).

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"We achieved significant progress in 2019, led by positive results from the interim analysis of the pivotal trial of KD025 in cGVHD that greatly exceeded the threshold for success, achieving overall response rates of 64% and 67% with KD025 200 mg QD and 200 mg BID, respectively; we also recently presented detailed efficacy and safety data from this trial, further underscoring the therapeutic potential of KD025 in this indication," said Harlan W. Waksal, M.D., President and CEO of Kadmon. "We will meet with the FDA later this month to discuss our planned NDA submission of KD025 and expect to provide an update of that meeting, along with topline results from the primary analysis of the pivotal trial, in the second quarter of 2020. Finally, we raised approximately $123 million and fully paid off our term debt in the fourth quarter of 2019, strengthening our financial position and ability to execute on our anticipated milestones."

2020 Anticipated Key Clinical Milestones:

KD025

Hold pre-New Drug Application (NDA) meeting with the U.S. Food and Drug Administration (FDA) in March 2020 to discuss regulatory pathway for KD025 in chronic graft-versus-host disease (cGVHD); provide an update on the meeting in the second quarter of 2020
Announce topline results from primary analysis of pivotal trial in cGVHD (KD025-213) in the second quarter of 2020
Complete enrollment in ongoing Phase 2 clinical trial in systemic sclerosis (KD025-209)
KD033

Initiate clinical trial of KD033, Kadmon’s anti-PD-L1/IL-15 fusion protein for the treatment of solid tumors, in the second quarter of 2020
KD045

Continue ongoing Investigational New Drug Application (IND)-enabling activities of KD045, Kadmon’s next-generation ROCK inhibitor for the treatment of fibrotic diseases
Q4 2019 Key Business Highlights:

Closed underwritten public offering of 29.9 million shares of common stock for gross proceeds of $101.6 million, including full exercise of the underwriters’ option to purchase additional shares
Divested 1.4 million ordinary shares of MeiraGTx Holdings plc (MGTX), bringing $22 million in net proceeds
Paid off term debt in full; the Company no longer maintains any term debt obligations
Established strategic partnerships to develop KD025 in China and Japan with BioNova Pharmaceuticals Ltd. (BioNova) and Meiji Seika Pharma Co., Ltd., respectively
Financial Results

Fourth Quarter 2019 Results

Loss from operations for the three months ended December 31, 2019 was $18.3 million, compared to $27.8 million for the same period in 2018.

The decrease in loss from operations was primarily due to $4.0 million of license revenue recognized by the Company during the three months ended December 31, 2019 related to the BioNova strategic partnership. The decrease was also driven by a decrease in research and development expense due to timing of direct external costs associated with development of KD025 and compensation for research and development personnel.

Full Year 2019 Results

Loss from operations for the year ended December 31, 2019 was $89.1 million, compared to $85.9 million for the same period in 2018.

The increase in loss from operations was primarily due to an increase in research and development expenses for the year ended December 31, 2019 of $7.5 million, offset by $4.0 million of revenue associated with the BioNova strategic partnership. The increase in research and development expenses was primarily related to direct external costs of KD025 development.

Liquidity and Capital Resources

At December 31, 2019, the Company’s cash and cash equivalents totaled $139.6 million, compared to $94.7 million at December 31, 2018. In addition, as of December 31, 2019, the Company held approximately 2.1 million ordinary shares of MGTX, a publicly traded, clinical-stage gene therapy company.

About KD025

KD025 is a selective oral inhibitor of Rho-associated coiled-coil kinase 2 (ROCK2), a signaling pathway that modulates immune response as well as fibrotic pathways. In addition to the pivotal trial in cGVHD, KD025 is being studied in an ongoing Phase 2 clinical trial in adults with diffuse cutaneous systemic sclerosis (KD025-209). The FDA has granted Breakthrough Therapy Designation to KD025 for the treatment of patients with cGVHD after failure of two or more prior lines of systemic therapy. The FDA has also granted Orphan Drug Designation to KD025 for the treatment of patients with cGVHD.