On May 15, 2019 Celsion Corporation (NASDAQ: CLSN), an oncology drug development company, reported financial results for the quarter ended March 31, 2019 and provided an update on its development programs for ThermoDox, its proprietary heat-activated liposomal encapsulation of doxorubicin, and GEN-1, an IL-12 DNA plasmid vector encased in a nanoparticle delivery system, which enables cell transfection followed by persistent, local secretion of the IL-12 protein (Press release, Celsion, MAY 15, 2019, View Source [SID1234536338]). The Company’s lead program is ThermoDox, which is currently in Phase III development for the treatment of hepatocellular carcinoma (HCC), or primary liver cancer. The Company’s immunotherapy candidate, GEN-1, is currently in Phase I/II development for the localized treatment of newly diagnosed Stage III/IV ovarian cancer.

Schedule your 30 min Free 1stOncology Demo!
Discover why more than 1,500 members use 1stOncology™ to excel in:

Early/Late Stage Pipeline Development - Target Scouting - Clinical Biomarkers - Indication Selection & Expansion - BD&L Contacts - Conference Reports - Combinatorial Drug Settings - Companion Diagnostics - Drug Repositioning - First-in-class Analysis - Competitive Analysis - Deals & Licensing

                  Schedule Your 30 min Free Demo!

"Celsion continues to make significant progress with our two ongoing clinical development programs for ThermoDox and GEN-1. With sound fundamentals and a strong balance sheet, we are well positioned to see our clinical programs through transformative milestones over the next year. We are looking forward to the first of two preplanned, interim efficacy analyses for the Phase III OPTIMA Study expected in the second half of 2019 and mid-2020, respectively. This global, pivotal study completed patient enrollment in August 2018 at over 65 clinical sites in 14 different countries, including all of the markets where primary liver cancer is a major problem," said Michael H. Tardugno, Celsion’s chairman, president and chief executive officer. "Our Phase I/II OVATION 2 Study in newly diagnosed ovarian cancer is now recruiting patients and continues to work through the activation of up to 31 clinical sites by the end of this year. Importantly, enrollment of patients in the Phase I portion of the study is expected to be complete and initial data reported by the end of 2019. This promising clinical development program in immunotherapy has generated impressive results in previous trials."

Recent Developments

ThermoDox

Issuance of New U.S. Patent for ThermoDox. On April 17, 2019, the Company announced that the United States Patent and Trademark Office granted U.S. Patent No. 10,251,901 B2 – Thermosensitive Nanoparticle Formulations and Method of Making the Same, which is directly applicable to the method of treating cancer using a new ThermoDox formulation. The claim covers a method for preparing (as well as the composition of) a doxorubicin sulfate temperature-sensitive liposome and extends coverage time over ThermoDox’s current patent portfolio to 2033. This new patent broadens our intellectual property portfolio providing for life cycle management of ThermoDox well into the future.

Publication of ThermoDox Study Results in the Peer-Reviewed Journal, Radiology. On January 17, 2019, the Company announced that results from the Phase I TARDOX trial of ThermoDox conducted at the University of Oxford, United Kingdom, were published in the peer-reviewed journal, Radiology. The findings published in Radiology serve as a companion paper to the groundbreaking work published in Lancet Oncology in July 2018. This was the first published study to evaluate ThermoDox when combined with high-intensity focused ultrasound (HIFU). The Radiology publication was accompanied by an editorial highlighting the significance of utilizing HIFU to safely deliver oncologically relevant concentrations of doxorubicin with ThermoDox.

The article, titled, "Focused Ultrasound Hyperthermia for Targeted Drug Release from Thermosensitive Liposomes: Results from a Phase I Trial," included an evaluation of the TARDOX results and the safety, efficacy and utility of treatment with ThermoDox plus targeted, non-invasive ultrasound in patients with solid liver tumors, with treatment plans based on patient-specific modeling.

The Phase I TARDOX study was carried out as a multi-disciplinary collaboration between Celsion, the Oxford University Institute of Biomedical Engineering, the Oncology Clinical Trials Office (OCTO) and the Oxford University Hospitals NHS Foundation Trust and evaluated patients with inoperable primary or secondary liver tumors who had previously received chemotherapy. In this trial, 10 patients received a single intravenous dose of 50 mg/m2 of ThermoDox, and ultrasonic heating of target tumors was monitored in six participants using a minimally invasive temperature sensor, while four patients were treated without real-time thermometry. The study demonstrated that focused ultrasound exposure with ThermoDox resulted in increased chemotherapy concentrations within liver tumors that were an average of 3.7 times greater than preheating levels across all 10 patients in the study.

Safety was assessed by analysis of magnetic resonance imaging (MRI) and biopsy specimens for evidence of thermal ablation, as well as adverse event monitoring. There was no evidence of focused ultrasound-related adverse effects, including thermal ablation.GEN-1 Immunotherapy

Presentation of GEN-1 Clinical Development Program at ASCO (Free ASCO Whitepaper)-SITC Clinical Immuno-Oncology Symposium. On March 4, 2019, the Company announced the oral presentation of data highlighting the safety, clinical response and translational data from the OVATION I Study by Premal H. Thaker, M.D., M.S., a nationally recognized expert in gynecologic oncology, Associate Professor of Obstetrics and Gynecology at the Siteman Cancer Center at the Washington University School of Medicine in St. Louis at the ASCO (Free ASCO Whitepaper)-SITC Clinical Immuno-Oncology Symposium.

Dr. Thaker’s presentation highlighted the following:

●The Phase IB OVATION I Study, which evaluated escalating doses of GEN-1 (36 mg/m2, 47 mg/m2, 61 mg/m2 and 79 mg/m2) administered intraperitoneally in combination with three cycles of neoadjuvant chemotherapy (NAC) prior to interval debulking surgery, followed by three cycles of NAC in the treatment of newly diagnosed patients with Stage III/IV ovarian cancer, demonstrated median PFS of 21 months in patients treated per protocol (n=14) and 17.1 months for the intent-to-treat population (n=18) for all dose cohorts, including three patients who dropped out of the study after 13 days or less, each of which compared favorably to the PFS historical average of 12 months for women with Stage III/IV ovarian cancer.
● Of the 14 patients who were evaluable for response, 100% of patients administered NAC plus the two higher doses of GEN-1 experienced an objective tumor response (defined as a partial or complete response) compared to only 60% of patients given the two lower doses.
●Patients in the two higher dose cohorts also had a high surgery success rate, with 88% of these patients achieving the optimal outcome of a complete (R0) resection. 100% of patients treated at the highest dose cohort had a complete R0 resection.
●Pre- and post-treatment levels of key ovarian cancer biomarkers were also measured as part of this study and showed marked reduction in immunosuppressive response across multiple biomarkers post-treatment, including FOXP3 and IDO-1 – an outcome not previously observed with NAC treatment alone.

Corporate Development

Celsion Participated in Two Investor Conferences. During May 2019, the Company attended the ThinkEquity Conference on May 2, 2019 at The Mandarin Oriental Hotel in New York City and the Deutsche Bank 44th Annual Health Care Conference on May 7-8, 2019 at The InterContinental Hotel in Boston. A webcast of Celsion’s presentation at the ThinkEquity Conference may be accessed by visiting the "News & Investors" section of Celsion’s corporate website. The format of the Deutsche Bank Health Care Conference was comprised of one-on-one and small group meetings with leading institutional investors.

Celsion Completed an Amendment to the Asset Purchase Agreement with EGEN, Inc. On March 28, 2019, the Company entered into an amendment to the June 6, 2014 Asset Purchase Agreement for the acquisition of substantially all of the assets of EGEN, Inc. The Amendment provides that payment of the $12.4 million earnout milestone liability under the Asset Purchase Agreement related to the Ovarian Cancer Indication can be made, at the Company’s sole discretion, in the following manner:

a)7.0 million in cash to EGWU within 10 business days of achieving the milestone; or

b)$12.4 million to EGWU, which is payable in cash, common stock of the Company, or a combination of either, within one year after achieving the milestone.

Additionally, the Amendment extends the Earnout Term as it applies to the Ovarian Cancer Milestone from seven (7) years to eight (8) years from the original signing date of the Asset Purchase Agreement. As consideration for entering into the Amendment, the Company will issue to EGWU 200,000 warrants to purchase common stock with an exercise price of $0.01 per share. The Company recorded this transaction in the first quarter of 2019.

Financial Results

For the quarter ended March 31, 2019, Celsion reported a net loss of $2.3 million ($0.12 per share) compared to a net loss of $4.5 million ($0.25 per share) for the quarter ended March 31, 2018. Operating expenses were $5.0 million for the quarter ended March 31, 2019, which represented a $0.6 million (13.6%) increase, from $4.4 million in the same period of 2018. During the first quarter of 2019, the Company incurred $0.7 million in non-cash stock option expense compared to $0.2 million in the comparable prior-year period.

Cash, cash equivalents, short-term investments and interest receivable at March 31, 2019 was $23.8 million. Cash provided by financing activities was approximately $1.8 million during the quarter ended March 31, 2019. Net cash used for operating activities was $5.5 million for the quarter ended March 31, 2019, compared to $4.6 million in the comparable prior-year period.

Research and development costs were $2.8 million for the quarter ended March 31, 2019 compared to $2.7 million for the quarter ended March 31, 2018. Clinical development costs for the Phase III OPTIMA Study were $0.9 million for the current quarter compared to $1.3 million for the same period of 2018. This $0.4 million decrease resulted from the completion of enrollment for this 556-patient trial in August 2018. Costs associated with the OVATION studies were $0.1 million for each of the quarters ended March 31, 2019 and 2018. The Company announced the completion of enrollment of all cohorts of the OVATION I Study in 2017 and the initiation of the follow-on Phase I/II OVATION 2 Study during 2018. Costs associated with Celsion’s wholly-owned subsidiary, CLSN Laboratories, Inc. (which includes research and development activities for GEN-1, TheraPlas and TheraSilence) were $0.6 million in each of the quarters ended March 31, 2019 and 2018 as the Company continues to expand its manufacturing capabilities and implemented programs to reduce manufacturing costs for GEN-1. In the first quarter of 2019, other clinical costs included an increase of $0.2 million in non-cash stock compensation expense compared to the same period of 2018.

General and administrative expenses were $2.2 million for the quarter ended March 31, 2019, compared to $1.7 million for the quarter ended March 31, 2018. This $0.5 million increase was due to higher compensation expenses totaling $0.5 million in 2019 compared to 2018. Compensation expenses include costs associated with new personnel additions as well as an increase of $0.3 million related to non-cash stock option compensation expense in 2019 compared to the prior year.

Other expenses included a non-cash gain of $2.7 million, net of charge a $0.4 million for the 200,000 warrant issuance related to an amendment for the potential milestone payments for the GEN-1 ovarian product candidate during the quarter ended March 31, 2019, compared to a non-cash charge of $270,000 for the quarter ended March 31, 2018. The Company realized $0.1 million of interest income from its short-term investments during the first quarter of 2019 and 2018. In connection with the Company’s new venture debt facility with Horizon in June 2018, the Company incurred interest expense of $0.4 million during the first quarter of 2019 compared to no interest expense in the first quarter of 2018.
First Quarter Conference Call

The Company is hosting a conference call to provide a business update and discuss its first quarter 2019 financial results at 11:00 a.m. EDT on Wednesday, May 15, 2019. To participate in the call, interested parties may dial 1-800-263-0877 (Toll-Free/North America) or 1-646-828-8143 (International/Toll) and ask for the Celsion Corporation First Quarter 2019 Earnings Call (Conference Code: 1231968) to register ten minutes before the call is scheduled to begin. The call will also be broadcast live on the internet at www.celsion.com. The call will be archived for replay on Wednesday, May 15, 2019 and will remain available until May 29, 2019. The replay can be accessed at 1-719-457-0820 or 1-888-203-1112 using Conference ID: 1231968. An audio replay of the call will also be available on the Company’s website, www.celsion.com, for 90 days after 2:00 p.m. EDT Wednesday, May 15, 2019.

On May 15, 2019 GRAIL, Inc., a healthcare company focused on the early detection of cancer, reported that new findings from its Circulating Cell-free Genome Atlas (CCGA) study will be presented in four poster presentations at the 2019 American Society of Clinical Oncology (ASCO) (Free ASCO Whitepaper) Annual Meeting taking place May 31 – June 4 in Chicago (Press release, Grail, MAY 15, 2019, View Source [SID1234536355]).

Schedule your 30 min Free 1stOncology Demo!
Discover why more than 1,500 members use 1stOncology™ to excel in:

Early/Late Stage Pipeline Development - Target Scouting - Clinical Biomarkers - Indication Selection & Expansion - BD&L Contacts - Conference Reports - Combinatorial Drug Settings - Companion Diagnostics - Drug Repositioning - First-in-class Analysis - Competitive Analysis - Deals & Licensing

                  Schedule Your 30 min Free Demo!

Previously reported data from the first sub-study of CCGA showed GRAIL’s prototype technology could detect the presence of multiple deadly cancer types with a low rate of false positive results (high specificity).1 An abstract posted online today ahead of the 2019 ASCO (Free ASCO Whitepaper) Annual Meeting reports data from an analysis from the first CCGA sub-study showing GRAIL’s prototype methylation technology detected the tumor tissue of origin (where the cancer originated in the body) with high accuracy (Abstract 3049). This analysis evaluated blood samples from 166 participants who had a cancer diagnosis at the time of enrollment, and whose cancer was detected using the methylation technology. Results showed the technology correctly identified the tumor’s tissue of origin in 87 percent of the blood samples evaluated (n=144/166), including 96 percent of breast cancer cases (n=22/23); 88 percent of lung cancer cases (n=29/33); 90 percent of liver cancer cases (n=9/10); and 100 percent of pancreatic cancer cases (n=17/17).

GRAIL has since selected methylation as its preferred approach and is now evaluating its refined methylation blood test in the second pre-planned sub-study of CCGA. Initial data from the second CCGA sub-study will be presented at ASCO (Free ASCO Whitepaper), reporting the ability of GRAIL’s methylation test to detect multiple cancer types and identify the tumor tissue of origin.

"Identifying the tumor tissue of origin will be a critical feature of our multi-cancer early detection test to enable doctors to appropriately direct next steps for diagnosis and care," said Alexander Aravanis, MD, PhD, Chief Scientific Officer at GRAIL. "Our unique test is designed to combine our methylation technology, a proprietary database of methylation signatures, and GRAIL’s machine-learning algorithms to both detect the presence of cancer and determine where in the body the cancer originated. We look forward to presenting initial results from our next CCGA sub-study at ASCO (Free ASCO Whitepaper)."

Survival Data (Abstract 1545)

Data presented last year showed GRAIL’s technology detected the strongest signals for the deadliest cancer types, while signal for indolent cancer types was low.1 A new analysis evaluated survival of 1,289 CCGA participants in the first CCGA sub-study with at least one year of clinical follow-up. Results showed people in the study whose cancer was detected by the methylation technology were three times more likely to die from their cancer compared to participants whose cancer was not detected by the technology, independent of clinical stage (HR=3.0, p<0.001). By comparison, participants with stage IV cancers were three times more likely to die than those with stage I-III cancers (HR=3.3, p<0.001). These data suggest detection with GRAIL’s methylation technology could have a similar ability to predict survival as clinical stage.

"Overdiagnosis of some cancer types that are slow-growing can be a concern with current screening tests," said Geoffrey Oxnard, MD, Associate Professor of Medicine at Dana-Farber Cancer Institute and Harvard Medical School. "These initial follow-up data are encouraging and add to the evidence from the CCGA study suggesting this blood test may detect the types of cancers more in need of immediate treatment, rather than contributing to the overdiagnosis of indolent cancers."

Follow-up of participants in CCGA is ongoing and outcomes will be collected for five years. These long-term data are important for determining the potential clinical impact of detecting deadly cancers in the blood before a person presents with symptoms.

Details for Posters Featuring GRAIL’s Data at ASCO (Free ASCO Whitepaper)

Abstract 3049
Minetta C. Liu, et al. Genome-wide cell-free DNA (cfDNA) methylation signatures and effect on tissue of origin (TOO) performance
Poster Session: June 1, 2019: 8:00-11:00AM CDT, Hall A, Poster Board #41

Abstract 3103
Darya Filippova, et al. The Circulating Cell-free Genome Atlas (CCGA) study: Size selection of cell-free DNA (cfDNA) fragments
Poster Session: June 1, 2019: 8:00-11:00AM CDT, Hall A, Poster Board #95

Abstract 5574
Allen Cohn, et al. The Circulating Cell-free Genome Atlas (CCGA) study: Follow-up (F/U) on non-cancer participants with cancer-like cell-free DNA signals
Poster Session: June 1, 2019: 1:15-4:15PM CDT, Hall A, Poster Board #397

Abstract 1545
Geoffrey R. Oxnard, et al. Prognostic significance of blood-based cancer detection in plasma cell-free DNA (cfDNA): Evaluating risk of overdiagnosis
Poster Session: June 3, 2019: 1:15-4:15PM CDT, Hall A, Poster Board #39

About the Circulating Cell-free Genome Atlas (CCGA) Study

The CCGA study is a prospective, observational, longitudinal study that has completed enrollment of approximately 15,000 people with and without cancer across 142 sites in the United States and Canada. GRAIL is conducting three pre-planned sub-studies within CCGA to discover, train, and validate its multi-cancer early detection test.

About GRAIL’s Methylation Technology

GRAIL is developing a next-generation sequencing (NGS) blood test for the early detection of multiple deadly cancer types. GRAIL’s high efficiency methylation technology preferentially targets the most informative regions of the genome, and is designed to use its proprietary database and machine-learning algorithms to both detect the presence of cancer and identify the tumor’s tissue of origin. GRAIL’s sequencing database of cancer and non-cancer methylation signatures is believed to be the largest of its kind, and covers approximately 30 million methylation sites across the genome. More than 20 cancer types across stages are represented within the database.

DNA methylation is a natural process used by cells to regulate gene expression. It is a chemical modification to DNA and a well-studied epigenomic feature of the genome. In cancer, abnormal methylation patterns and the resulting changes in gene expression can contribute to tumor growth. For example, hypermethylation can cause tumor-suppressor genes to be inactivated.

On May 15, 2019 Daiichi Sankyo Company, Limited (hereafter, Daiichi Sankyo) reported that it will present new data for several investigational compounds in the Daiichi Sankyo oncology pipeline at the 2019 American Society of Clinical Oncology (ASCO) (Free ASCO Whitepaper) Annual Meeting to be held May 31 to June 4 in Chicago (Press release, Daiichi Sankyo, MAY 15, 2019, https://www.prnewswire.com/news-releases/daiichi-sankyo-data-presentations-at-2019-asco-annual-meeting-highlight-depth-of-adc-pipeline-and-promises-of-oncology-portfolio-300851100.html [SID1234536371]).

Schedule your 30 min Free 1stOncology Demo!
Discover why more than 1,500 members use 1stOncology™ to excel in:

Early/Late Stage Pipeline Development - Target Scouting - Clinical Biomarkers - Indication Selection & Expansion - BD&L Contacts - Conference Reports - Combinatorial Drug Settings - Companion Diagnostics - Drug Repositioning - First-in-class Analysis - Competitive Analysis - Deals & Licensing

                  Schedule Your 30 min Free Demo!

Highlights include new data for two investigational antibody drug conjugates (ADCs) being evaluated in patients with non-small cell lung cancer (NSCLC), including first-in-human results for DS-1062, a TROP2 targeting ADC in advanced NSCLC, and the first phase 1 results for U3-1402, a HER3 targeting ADC, in EGFR mutated, TKI resistant metastatic NSCLC.

"We look forward to showcasing the broad applicability of our proprietary DXd ADC technology with initial results for DS-1062, our third ADC, which we designed to target TROP2 in lung and other cancers, and for U3-1402, which is being studied in lung and breast cancers," said Antoine Yver, MD, MSc, EVP and Global Head, Oncology Research and Development, Daiichi Sankyo. "The ASCO (Free ASCO Whitepaper) meeting presentations demonstrate the depth of our ADC pipeline beyond [fam-] trastuzumab deruxtecan (DS-8201), as well as the breadth of opportunities across our portfolio to translate our innovative science into potential new targeted cancer therapies."

Both DS-1062 and U3-1402 are designed using Daiichi Sankyo’s proprietary DXd ADC technology, which consists of a humanized monoclonal antibody attached to a novel topoisomerase I inhibitor payload by a tetrapeptide-based linker. The ADCs were constructed to target and deliver chemotherapy inside cancer cells that express a specific cell surface antigen.

Additional data to be reported at ASCO (Free ASCO Whitepaper) includes a pooled analysis of long-term treatment data from the phase 3 ENLIVEN and phase 1 extension study of pexidartinib in tenosynovial giant cell tumor (TGCT) and first-in-human phase 1 results with DS-1001 in patients with IDH1 mutant gliomas. An overview of data from the Daiichi Sankyo oncology pipeline to be presented includes:

First-in-human phase 1 study of DS-1062a in patients with advanced solid tumors (Abstract 9051. Poster Session: Lung Cancer – Non-Small Cell Metastatic. Sunday, June 2, 8:00 – 11:00 AM CDT)
Safety and preliminary antitumor activity of U3-1402: A HER3-targeted antibody drug conjugate in EGFR TKI-resistant, EGFRm NSCLC (Abstract 9010. Clinical Science Symposium: EGFR and ROS1: Targeting Resistance. Lung Cancer – Non-Small Cell Metastatic. Friday, May 31, 1:00 – 2:30 PM CDT)
A phase III, multicenter, randomized, open label trial of [fam-] trastuzumab deruxtecan (DS-8201a) versus investigator’s choice in HER2-low breast cancer (Abstract TPS1102. Poster Session: Breast Cancer – Metastatic. Sunday, June 2, 8:00 – 11:00 AM CDT)
Phase 1 study of a brain penetrant mutant IDH1 inhibitor DS-1001b in patients with recurrent or progressive IDH1 mutant gliomas (Abstract 2004. Oral Abstract Session: Central Nervous System Tumors. Monday, June 3, 1:15 – 4:15 PM CDT)
Pexidartinib for advanced tenosynovial giant cell tumor (TGCT): Long-term efficacy and safety from the phase 3 ENLIVEN and phase 1 PLX108-01 (TGCT cohort) studies (Abstract 11042. Poster Session: Sarcoma. Saturday, June 1, 8:00 – 11:00 AM CDT)
Responder analysis of Patient-Reported outcomes Measurement Information System (PROMIS) physical function (PF) and worst stiffness among patients with tenosynovial giant cell tumors (TGCT) in the ENLIVEN study (Abstract e18236; Publication Only)
Work productivity loss in patients with Tenosynovial Giant Cell Tumors (TGCT) in the United States (Abstract e22527; Publication Only)
A phase 1 study of milademetan in combination with quizartinib in patients with newly diagnosed or relapsed/refractory FLT3-ITD acute myeloid leukemia (AML) (Abstract TPS7067. Poster Session: Hematologic Malignancies – Leukemia, Myelodysplastic Syndromes, and Allotransplant. Monday, June 3, 8:00 – 11:00 AM CDT)
These are investigational agents that have not been approved for any indication in any country. Safety and efficacy have not been established.

About Daiichi Sankyo Cancer Enterprise
The mission of Daiichi Sankyo Cancer Enterprise is to leverage our world-class, innovative science and push beyond traditional thinking to create meaningful treatments for patients with cancer. We are dedicated to transforming science into value for patients, and this sense of obligation informs everything we do. Anchored by three pillars including our investigational Antibody Drug Conjugate Franchise, Acute Myeloid Leukemia Franchise and Breakthrough Science, we aim to deliver seven distinct new molecular entities over eight years during 2018 to 2025. Our powerful research engines include two laboratories for biologic/immuno-oncology and small molecules in Japan, and Plexxikon Inc., our small molecule structure-guided R&D center in Berkeley, CA. Compounds in pivotal stage development include: [fam-] trastuzumab deruxtecan, an antibody drug conjugate (ADC) for HER2 expressing breast, gastric and other cancers; quizartinib, an oral selective FLT3 inhibitor, for newly-diagnosed and relapsed/refractory FLT3-ITD acute myeloid leukemia (AML); and pexidartinib, an oral CSF1R inhibitor, for tenosynovial giant cell tumor (TGCT). For more information, please visit: www.DSCancerEnterprise.com.

On May 15, 2019 INmune Bio, Inc. (NASDAQ:INMB), an immunology company focused on developing treatments that harness the patient’s innate immune system to fight disease, reported its financial results and is providing a business update for the first quarter ended March 31, 2019 (Press release, INmune Bio, MAY 15, 2019, View Source [SID1234536418]).

Schedule your 30 min Free 1stOncology Demo!
Discover why more than 1,500 members use 1stOncology™ to excel in:

Early/Late Stage Pipeline Development - Target Scouting - Clinical Biomarkers - Indication Selection & Expansion - BD&L Contacts - Conference Reports - Combinatorial Drug Settings - Companion Diagnostics - Drug Repositioning - First-in-class Analysis - Competitive Analysis - Deals & Licensing

                  Schedule Your 30 min Free Demo!

Corporate Highlights in 2019:

·First biotechnology company to close initial public offering in 2019 and commence trading on The Nasdaq Capital Market.

·Received the Part the Cloud Award from the Alzheimer’s Association, including a $1 million grant to advance XPro1595, a novel therapy targeting neuroinflammation as a cause of Alzheimer’s disease.

"2019 has marked a transformative period for INmune Bio, as the first biotech of the year to close its IPO and list on the Nasdaq," stated RJ Tesi, M.D., Chief Executive Officer of INmune Bio. "We are focused on advancing our clinical programs for the foreseeable future."

Our clinical programs continue to advance:

·INB03, our program targeting resistance to immunotherapy caused by myeloid derived suppressor ells (MDSC), completing a monotherapy Phase I trial in patients with advanced solid tumors, will transition into a combination therapy clinical program this summer in preparation for a Phase II trial in patients resistant to checkpoint inhibitors due to increased MDSC that should begin in 2020. INB03 targets MDSC – one of the causes of resistance to checkpoint inhibitors. Treatment with INB03 should eliminate the MDSC in the tumor microenvironment to allow CPI to be therapeutically effective.

·INKmune, our NK cell therapy focused on eliminating residual disease after cancer therapy will start enrolling patients in a Phase I/II trial in women with relapsed refractory ovarian cancer later this year. In many patients, cancer relapse after seemingly effective cancer therapy is due to a failure of their NK cells to eliminate minimal residual disease (MRD). INKmune, by priming the patient’s NK cells to attack their tumor, should eliminate MRD to prevent relapse.

·The Phase I clinical trial in patients with Alzheimer’s disease (AD) should enroll its first patient this summer. The open label dose escalation trial in patients with mild to moderate AD has a novel biomarker strategy to determine if XPro1595 will eliminate neuroinflammation in patients after 3 months of therapy. XPro1595 targets microglial cells, the immune cells of the brain, that are activated in many patients with AD and is a cause of neuroinflammation that can kill nerve cells and promote synaptic dysfunction – the cause of dementia in AD. If successful, the company will consider initiating a Phase II trial in AD patients who have neuroinflammation as a cause of their dementia.

Financial Results for the First Quarter Ended March 31, 2019:

Net loss attributable to common stockholders for the first quarter ended March 31, 2019 was $1.9 million, compared to $2.8 million for the quarter ended March 31, 2018. Net loss incurred during the quarter ended March 31, 2019 included noncash stock-based compensation expense of $1.0 million.

Research and development expense totaled approximately $0.1 million for the first quarter ended March 31, 2019, compared with approximately $0.1 million for the quarter ended March 31, 2018. During the three months ended March 31, 2019, research and development expense included $0.4 million of research and development expense incurred for our clinical trials, partially offset by a grant received from the Alzheimer’s Association of which $0.3 million was recorded as contra-research and development expense.

General and administrative expense was approximately $1.8 million in the quarter ended March 31, 2019, compared to approximately $2.7 million in the quarter ended March 31, 2018. The $0.9 million decline in general and administrative expense is due to lower noncash stock-based compensation ($1.0 million for the quarter ended March 31, 2019 compared to $2.5 million for the quarter ended March 31, 2018), partially offset by higher general and administrative expenses including professional fees and payroll expense.

At March 31, 2019, the Company had cash and cash equivalents of approximately $6.0 million with no debt. Subsequently, the Company received proceeds of $4.7 million at a purchase price of $9.00 per share led by RJ Tesi, CEO, David Moss, CFO, and existing shareholders.

As of May 10, 2019 the Company had 10.3 million common and 13.3 million fully diluted shares outstanding.

About INmune Bio, Inc.

INmune Bio, Inc. is a publicly traded (INMB) clinical-stage biotechnology company developing therapies targeting the innate immune system to fight disease. INmune Bio is developing three product platforms: two products that reengineer the patient’s innate immune system’s response to cancer and one pr

On May 15, 2019 EDAP TMS SA (Nasdaq: EDAP) ("the Company"), the global leader in therapeutic ultrasound, reported financial results for the first quarter of 2019, and provided an update on strategic and operational developments (Press release, EDAP TMS, MAY 15, 2019, View Source [SID1234536434]).

Schedule your 30 min Free 1stOncology Demo!
Discover why more than 1,500 members use 1stOncology™ to excel in:

Early/Late Stage Pipeline Development - Target Scouting - Clinical Biomarkers - Indication Selection & Expansion - BD&L Contacts - Conference Reports - Combinatorial Drug Settings - Companion Diagnostics - Drug Repositioning - First-in-class Analysis - Competitive Analysis - Deals & Licensing

                  Schedule Your 30 min Free Demo!

Marc Oczachowski, EDAP’s Chief Executive Officer, said: "We are very pleased with these strong Q1 results showing high growth in our HIFU revenues which helped drive another quarter of global profitability. This is consistent with our 2018 results and demonstrates the continued momentum of our HIFU business, particularly in the U.S. We are excited by the strong interest and traction we experienced during the AUA meeting last week in Chicago. We look forward to providing further updates on potential additional sales in the U.S. and other key territories in the coming months."

First Quarter 2019 Results

Total revenue for the first quarter 2019 was EUR 10.1 million (USD 11.5 million), a 10.6% increase compared to EUR 9.2 million (USD 11.3 million) for the first quarter of 2018.

Total revenue in the HIFU business for the first quarter 2019 was EUR 3.9 million (USD 4.4 million), a 58.6% increase compared to EUR 2.4 million (USD 3.0 million) for the first quarter of 2018.

For the three months ended March 31, 2019, total revenue for the UDS division was EUR 6.3 million (USD 7.1 million), a 6.8% decrease compared to EUR 6.7 million (USD 8.3 million) during the year-ago period.

Gross profit for the first quarter 2019 was EUR 4.9 million (USD 5.5 million), compared to EUR 4.0 million (USD 4.9 million) for the year-ago period. Gross profit margin on net sales was 48.0% in the first quarter of 2019, compared to 43.8% in the year-ago period.

Operating expenses were EUR 4.7 million (USD 5.3 million) for the first quarter of 2019, compared to EUR 4.4 million (USD 5.4 million) for the same period in 2018.

Operating profit for the first quarter 2019 was EUR 0.2 million (USD 0.2 million), compared to an operating loss of EUR 0.4 million (USD 0.5 million) in the first quarter of 2018.

Net income for the first quarter 2018 was EUR 0.3 million (USD 0.4 million), or earnings of EUR 0.01 per diluted share, as compared to a net income of EUR 0.1 million (USD 0.1 million), or earnings of EUR 0.00 per diluted share in the year-ago period.

As of March 31, 2019, cash and cash equivalents were EUR 18.6 million (USD 20.8 million).

Conference Call

An accompanying conference call will be conducted by Philippe Chauveau, Chairman of the Board; Marc Oczachowski, Chief Executive Officer; and François Dietsch, Chief Financial Officer, to review the results. The call will be held at 8:30 AM ET, on Thursday May 16, 2019. Please refer to the information below for conference call dial-in information and webcast registration.

Conference Call & Webcast
Thursday, May 16 @ 8:30am Eastern Time

Domestic:
International:
Passcode:
Webcast: 877-451-6152
201-389-0879
13690430
View Source
Following the live call, a replay will be available on the Company’s website, www.edap-tms.com under "Investors Information."