On March 24, 2020 IASO Biotherapeutics (IASO BIO) reported the completion of $60 million in series B financing led by GL Ventures, which is a venture capital fund of Hillhouse Capital focusing on early-stage innovative companies (Press release, IASO BioMed, MAR 24, 2020, View Source [SID1234555793]). Biomedicine and medical devices are its key investment areas. This new funding will go toward expanding the company’s product pipeline, promoting the progress of current projects (including regulatory applications and clinical trials in China and the United States), improving the technology of a fully-human antibody development platform, expanding cooperation with leading international research and development institutions, and accelerating the construction of commercial facilities.

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IASO BIO is a clinical-stage biotechnology company dedicated to the development of innovative cell therapies for cancer. Founded in March 2017, the company is developing over 10 pipeline products, focusing on autologous and universal CAR-T products for hematological tumors. All products are based on fully-human sequence. Additional development efforts include unique TCR-like CAR-T cell therapy products for solid tumor indications such as viral infection related gastric cancer and nasopharyngeal carcinoma.

IASO BIO owns a proprietary phage display library（>2×1011）that supports the demand for fully-human antibodies required for CAR-T and lays the foundation for the development of antibody drug pipelines as well. Its in-house plasmid, lentivirus and CAR-T production technology platforms can meet the requirements of IND submissions and clinical research for multiple products.

In September 2019, IASO BIO received NMPA approval of a phase Ib/II IND application for CT103A, an anti-BCMA CAR-T co-developed with Innovent Biologics for the treatment of relapsed refractory multiple myeloma (rr/mm). In addition, a number of new drug candidates have entered the pre-clinical stage or are involved in investigator-initiated clinical trials, with several of these drugs expected to enter clinical trials in the next two years.

"IASO BIO welcomes the support and investment from Hillhouse Capital, and we view them as our long-term partner," said Brian Hall, co-Founder and Executive Vice President of Business Development, IASO BIO. "With their support and guidance, we are very confident in our ability to execute on our vision for the company. Their commitment enables us to accelerate the progress of research projects, enhance the team’s capabilities globally, bring new hope to patients, and attract the right talent with ambition to join us."

Michael Yi, Co-CIO of Hillhouse Capital, stated, "Biomedicine is one of the areas that is most thoroughly investigated and heavily involved in by Hillhouse. We are dedicated to creating value in this industry and promoting the growth of companies with ingenuity, innovation, vision and devotion. We are deeply impressed by IASO BIO’s diverse team and proactive culture. IASO BIO boasts a unique development platform for fully-human antibody, a solid CMC process for plasmid viruses and cell products, efficient corporate governance, and innovative products with excellent clinical data. IASO BIO also has strategic collaborations with leading international research institutions. What an achievement to have built up such capability and potential in a time span of just three years! It gives us great pleasure to cooperate with IASO BIO and we hope to contribute to their becoming an internationally competitive company with a portfolio of innovative drugs."

On March 24, 2020 BioInvent International AB ("BioInvent") (OMXS: BINV) reported an agreement with SkylineDx to characterize the gene expression and immunological signatures in tumors of patients pre- and post-treatment with BI-1206 (Press release, BioInvent, MAR 24, 2020, View Source [SID1234555792]).

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SkylineDx is a molecular diagnostics company which focuses on the discovery of novel gene-based biomarkers with high clinical utility for patient targeting and stratification. Headquartered in Rotterdam, the Netherlands, SkylineDx operates a CAP/CLIA certified laboratory in San Diego, California, USA.

Together the companies will research and develop predictive immunological signatures to help identify patients with non-Hodgkin lymphoma (NHL) and solid cancers who are likely to show clinical responses if treated with BI-1206, BioInvent’s lead product candidate.

Martin Welschof, CEO of BioInvent, said: "We are delighted to be working with SkylineDx, a company that has built up a great deal of expertise in molecular diagnostics, which is essential for the development of targeted cancer therapies. Identifying the right patients who are likely to respond to treatment with BI-1206 will constitute a major asset in the development of this promising treatment and, along with FcγRIIB expression levels, should support the extension of its use to other malignancies."

Dharminder Chahal, CEO of SkylineDx, said: "It is a real pleasure to announce our collaboration with Bioinvent, a true pioneer in promising new cancer treatments. As a diagnostics company, we always strive for precision medicine. Joining forces to identify true responders in early phase pharmaceutical trials, will make mark an important milestone towards that goal."

On March 24, 2020 EDAP TMS SA (Nasdaq: EDAP), the global leader in robotic energy-based therapies, reported that it will release its financial results for the fourth quarter and year ended December 31, 2019 after the markets close on Monday, March 30, 2020 (Press release, EDAP TMS, MAR 24, 2020, View Source [SID1234555791]).

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An accompanying conference call and webcast will be conducted by Marc Oczachowski, Chief Executive Officer and François Dietsch, Chief Financial Officer, to review the results. The call will be held at 8:30am EDT on Tuesday, March 31, 2020. Please refer to the information below for conference call dial-in information and webcast registration.

Conference Call & Webcast
Tuesday, March 31st @ 8:30am Eastern Time
Domestic: 877-451-6152
International: 201-389-0879
Passcode: 13700921
Webcast: View Source

On March 24, 2020 The biotechnology company focused on developing curative gene therapies for chronic systemic diseases reported that it has appointment of Julie Krop M.D. as Chief Medical Officer (CMO) with effect from 1st April 2020 (Press release, UCLB, MAR 24, 2020, View Source [SID1234555790]).

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On March 24, 2020 Sun BioPharma, Inc. (OTCQB: SNBP), a clinical stage biopharmaceutical company developing disruptive therapeutics for the treatment of pancreatic cancer, reported financial results for the year ended December 31, 2019 (Press release, Sun BioPharma, MAR 24, 2020, View Source [SID1234555789]). Sun BioPharma is developing SBP-101, a proprietary polyamine analogue designed to induce polyamine metabolic inhibition (PMI), a metabolic pathway of critical importance to cell function in multiple tumor types, including pancreatic cancer.

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"I am delighted with the progress we have made in advancing the development of SBP-101 for patients with metastatic pancreatic cancer. In the past 12 months, we have completed enrollment in the four dose escalation cohorts of our current trial, presented interim data ASCO (Free ASCO Whitepaper) GI Cancer Symposium, initiated two new clinical sites in the United States, and opened an expansion cohort to patient enrollment at what we believe to be the optimal dose and schedule," said Michael T. Cullen, MD, MBA, Chairman and CEO of Sun BioPharma. "We look forward to completing the design of a randomized phase 2 study."

Significant Progress Made in Advancing SBP-101 Clinical Development
In early 2020, enrollment was completed in the fourth cohort of the ongoing Phase 1a/1b study of SBP-101 in patients with metastatic pancreatic ductal adenocarcinoma (PDA). Based upon the study data generated to date, an expansion cohort in patients with PDA was initiated in February of 2020. This expansion phase will enroll up to 36 additional patients at the recommended dose and schedule. A total of six clinical sites are now participating in the SBP-101 clinical program.

Interim Phase 1 Results Presented in Poster Session at ASCO (Free ASCO Whitepaper) GI Cancers Symposium Interim Phase 1 clinical data for SBP-101 was presented in a poster session at the American Society for Clinical Oncology (ASCO) (Free ASCO Whitepaper) 2020 Gastrointestinal Cancers Symposium on January 24, 2020. The adverse event profile of SBP-101 below the maximal tolerated dose was manageable, and SBP-101 was well tolerated in combination with gemcitabine and nab-paclitaxel. The addition of SBP-101 to the combination of gemcitabine plus nab-paclitaxel did not increase the frequency of moderate or severe hematologic adverse events, peripheral neuropathy, nausea or diarrhea when compared to historical control data for patients who were treated with gemcitabine plus nab-paclitaxel. The most common adverse events attributed to treatment with SBP-101 were fatigue, elevated hepatic enzymes, and injection site pain.

Available study results in 13 evaluable subjects enrolled in the two highest dose cohorts (n=16) demonstrated an overall response rate (ORR) of 62% by RECIST criteria. The disease control rate (DCR) was 85% by RECIST criteria. Eleven subjects in those cohorts (69%, n=16) saw a maximum decrease in CA 19-9 of more than 60%.

Financial Results for the Three Months and Full Year Ended December 31, 2019

General and administrative (G&A) expenses were flat at $468,000 in the fourth quarter of 2019, compared with $467,000 in the fourth quarter of 2018. G&A expenses for the full year decreased 6.4% to $2.0 million in 2019, down from $2.1 million in 2018. The decrease for the full year of 2019 is primarily due to fewer staff members versus the 2018 staff level.

Research and development (R&D) expenses increased 74.9% to $787,000 in the fourth quarter of 2019 up from $450,000 in the fourth quarter of 2018. R&D expenses for the full year of 2019 increased 31.7% to $2.3 million as compared with $1.8 million for 2018. The increase in the fourth quarter resulted from the cost to begin production of drug substance for future phase 2 clinical trials. The full-year increase in R&D expenses resulted from an increase in spending on the Company’s clinical trial during 2019 and the manufacturing of drug substance initiated during the fourth quarter of 2019.

Other income, net, was $196,000 in the current quarter compared to other expense, net, of $64,000 in the fourth quarter of 2018. Other expense, net, was flat at $2.3 million for both 2019 and 2018. The amounts reflected in the fourth quarter of each year are primarily a foreign currency translation adjustment on the intercompany balance with our Australian subsidiary. For both 2018 and 2019 the full year expense is primarily the amortization of debt discount, which is recorded as interest expense.

Net loss for the quarters ended December 31, 2019 and 2018 was $1.0 million and $0.9 million, or $0.15 and $0.18 per diluted share, respectively. The net loss for the full year 2019 was $6.2 million, or $1.09 per diluted share, compared to a net loss of $5.9 million, or $1.27 per diluted share, for 2018.

Balance Sheet and Cash Flow

Total cash resources were $2.4 million as of December 31, 2019, compared to $1.4 million as of December 31, 2018. Total current assets were $3.1 million and $1.8 million as of December 31, 2019, and December 31, 2018, respectively. These increases resulted primarily from the proceeds raised from the sale of convertible promissory notes in January 2019 of $0.8 million and the sale of equity securities in the second half of 2019 totaling $3.2 million, partially offset by the Company’s use of cash to fund operations during 2019.

Current liabilities increased to $1.8 million as of December 31, 2019, compared to $1.6 million as of December 31, 2018. The increase in current liabilities is reflective of an increase in vendor payables associated with increased clinical and manufacturing activity in 2019.

Net cash used in operating activities was $2.7 million for the year ended December 31, 2019, compared to $2.4 million for the year ended December 31, 2018. The net cash used in each of these periods primarily reflected the net loss for these periods and was partially offset by stockbased compensation expense and amortization of debt discount as well as by the effects of changes in operating assets and liabilities.