On September 10, 2021 Y-mAbs Therapeutics, Inc. (the "Company" or "Y-mAbs") (Nasdaq: YMAB) a commercial-stage biopharmaceutical company focused on the development and commercialization of novel, antibody-based therapeutic products for the treatment of cancer, reported that it will host a key opinion leader ("KOL") webinar on DANYELZA frontline and HITS data in high-risk neuroblastoma on Thursday, September 23, 2021 at 12 p.m. ET (Press release, Y-mAbs Therapeutics, SEP 10, 2021, View Source [SID1234587547]).

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!

This webinar will feature presentations from KOLs Jaume Mora, M.D., Ph.D., SJD Barcelona Children’s Hospital, and Shakeel Modak, M.D., MRCP, Memorial Sloan Kettering. Additionally, Thomas Gad, Chairman, Founder, and President at Y-mAbs, will provide a brief introduction followed by presentations from Steen Lisby, M.D., DMSc, SVP, Chief Scientific Officer at Y-mAbs, and Claus J. Moller San-Pedro, M.D., Ph.D., Chief Executive Officer at Y-mAbs.

Dr. Mora will present frontline data for DANYELZA in High-Risk Neuroblastoma
Dr. Modak will present HITS data for DANYELZA in High-Risk Neuroblastoma
Dr. Lisby will review Y-mAbs’ preclinical and research pipeline including its SADA technology
Dr. Moller will provide a corporate update
Thomas Gad as well as Drs. Modak, Mora, Lisby, and Moller will be available for questions following the presentations.

To register for the event, please click here.

Shakeel Modak, M.D., MRCP is a pediatric hematology-oncology doctor at Memorial Sloan Kettering Cancer Center, Department of Pediatrics in New York. He received his MBBS and M.D. degrees from TN Medical College, Bombay, as well as his MRCP degree from Royal College of Physicians, London. Dr. Modak specializes in the treatment of children and young adults with neuroblastoma and other solid tumors, such as DSRCT. He has been named to Best Doctors, New York City by Castle Connolly for the past six years in a row and in 2014. Dr. Modak has been the principal investigator on more than 12 studies in neuroblastoma and DSRCT. He has also been the co-investigator on over 50 trial protocols.

Jaume Mora, M.D., Ph.D. is the scientific director of the Oncology and Hematology area at SJD Barcelona Children’s Hospital, as well as the director of the Developmental Tumors Laboratory at SJD Barcelona Children’s Hospital. Dr. Mora is a member of several; national and international scientific societies, including the International Pediatric Oncology Society, which has awarded him the Schweisguth Prize, and the American Society of Clinical Oncology (ASCO) (Free ASCO Whitepaper) ("ASCO"), which honored him with the young investigator award ("YIA") in 2000, as well as the Career Development Award ("CDA"). In 2011, Dr. Mora was the recipient of the annual BBVA Foundation Award and, in 2006, of the First Prize of the Spanish Association Against Cancer ("AECC") award for the study of childhood cancer.

About DANYELZA (naxitamab-gqgk)

DANYELZA (naxitamab-gqgk) is indicated, in combination with granulocyte-macrophage colony-stimulating factor ("GM-CSF"), for the treatment of pediatric patients one year of age and older and adult patients with relapsed or refractory high-risk neuroblastoma in the bone or bone marrow who have demonstrated a partial response, minor response, or stable disease to prior therapy. This indication was approved by the FDA under accelerated approval based on overall response rate and duration of response. Continued approval for this indication may be contingent upon verification and description of clinical benefits in a confirmatory trial. DANYELZA includes a Boxed Warning for serious infusion-related reactions, such as cardiac arrest and anaphylaxis, and neurotoxicity, such as severe neuropathic pain and transverse myelitis. See full Prescribing Information for complete Boxed Warning and other important safety information.

On September 10, 2021 Kazia Therapeutics Limited (NASDAQ: KZIA; ASX: KZA), an oncology-focused drug development company, reported that CEO, Dr James Garner, will be presenting at the HC Wainwright 23rd Annual Global Investment Conference, to be held virtually from 13-15 September 2021 (Press release, Kazia Therapeutics, SEP 10, 2021, https://www.prnewswire.com/news-releases/kazia-therapeutics-to-present-at-hc-wainwright-23rd-annual-global-investment-conference-301373181.html [SID1234587563]).

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!

The HC Wainwright Annual Global Investment Conference is one of the key events in the investor calendar and Kazia’s participation comes at an important time for the company. Kazia’s lead program, paxalisib, is currently in a pivotal study for glioblastoma, the most common and most aggressive form of brain cancer. If successful, paxalisib has the potential to become the first new drug treatment for newly diagnosed patients in almost twenty years, addressing a market worth US$ 1.5 billion per annum. More than 12,500 patients are diagnosed with glioblastoma each year, and the current standard of care treatment, temozolomide, is ineffective for approximately two-thirds of cases.

Dr Garner will provide an overview of Kazia’s key developments during FY2021, including:

Commencement of the GBM AGILE pivotal study for paxalisib in January 2021;
Out-licensing deal with Simcere Pharmaceutical for Greater China rights to paxalisib in March 2021, realizing an US$11 million upfront consideration;
Transformative in-licensing of EVT801 from Evotec, providing the company with a highly attractive second oncology asset.
Dr Garner will also share insights on Kazia’s objectives for FY2022 and outline the rich suite of catalysts that the company expects to announce during the remainder of CY2021.

This year’s HC Wainwright Annual Global Investment Conference will be conducted virtually from Monday 13th to Wednesday 15th and will feature more than 850 presenting companies, as well as a keynote presentation from Dr Scott Gottleib, former commissioner of the FDA.

Dr Garner commented, "Kazia’s presentation will be available to attendees on-demand, while the company will also meet individually with key investors and analysts over the duration of the conference to further advocate on behalf of the company’s compelling story."

On September 10, 2021 NexImmune, Inc. (Nasdaq: NEXI), a clinical-stage biotechnology company developing a novel approach to immunotherapy designed to orchestrate a targeted immune response by directing the function of antigen-specific T cells, reported that Scott Carmer, Chief Executive Officer, will participate in a fireside chat during the Morgan Stanley 19th Annual Global Healthcare Conference today, September 10, 2021 at 1:15p.m. Eastern time.

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!

The webcast will be accessible on the Investor Relations page of NexImmune’s website at Events and Presentations | NexImmune, Inc. A replay of the presentation will be available at the same location for 30 days following the conference.

On September 10, 2021 The board of directors of AbbVie Inc. (NYSE: ABBV) reported a quarterly cash dividend of $1.30 per share (Press release, AbbVie, SEP 10, 2021, View Source [SID1234587564]).

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!

The cash dividend is payable November 15, 2021 to stockholders of record at the close of business on October 15, 2021.

Since the company’s inception in 2013, AbbVie has increased its dividend by 225 percent. AbbVie is a member of the S&P Dividend Aristocrats Index, which tracks companies that have annually increased their dividend for at least 25 consecutive years.

On September 10, 2021 Oncoinvent reported that Quarterly report Q2 2021 (Press release, Oncoinvent, SEP 10, 2021, https://www.oncoinvent.com/wp-content/uploads/Oncoinvent-Quarterly-report-Q2-2021.pdf [SID1234587581])

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

• Secured NOK 250 mill. in an oversubscribed private placement
• The Safety and Monitoring Committee approved 7 MBq as recommended clinical dose for Radspherin in the ongoing RAD-18-002 phase 1 trial in patients suffering from colorectal cancer.
• The repeated dose cohort in the RAD-18-002 phase 1 trial has been completed. Operational review During the second quarter of 2021 Oncoinvent secured NOK 250 million in an oversubscribed private placement that was syndicated by existing investors Hadean Ventures, Geveran, RADFORSK Investeringsstiftelse, Sundt, Must Invest, Canica, MP Pensjon and Watrium.

The net proceeds from the Private Placement ensures financing past the end of 2023 for the lead product candidate Radspherin, including financing of two clinical phase 2A studies (in ovarian cancer and colorectal cancer). The funding will also allow the company to initiate preclinical development of proprietary antibodies OI-1 and OI-3 to further develop the pipeline of targeted radiotherapeutics one year earlier than originally planned. As previously announced in April 2021, Oncoinvent completed the recruitment of patients in the final dose level of the ongoing RAD-18-002 Phase 1 trial, in colorectal cancer patients suffering from peritoneal carcinomatosis.

The Safety and Monitoring Committee (SMC) concluded that the 7 MBq dose of Radspherin to be safe and it was recommended as the clinically relevant dose. During the second quarter the company has recruited patients to both the repeated dose cohort and expansion cohort. The repeated dose cohort has been completed and four of the six patients in the expansion cohort have been enrolled.

The company plans to complete enrollment of the entire RAD-18-002 colorectal cancer phase 1 study before the end of the third quarter.

During the second quarter of 2021 the company also enrolled patients for third dose level (4MBq) for the RAD-18-001 Phase 1 trial in platinum sensitive recurrent ovarian cancer patients suffering from peritoneal carcinomatosis. During this quarter the recruitment for the study has been slower than anticipated, and the company is currently taking steps to improve the enrollment going forward.

Financial review Oncoinvent had an EBITDA of minus NOK 17.4 mill. in the 2nd quarter of 2021, compared to minus NOK 12.8 in 2nd quarter of 2020. The operating expenses increased during the quarter and were NOK 18.3 mill. compared to NOK 15.7 mill. in 2020.

Furthermore, the company reported EBITDA of minus NOK 35.0 mill. for YTD compared to minus NOK 25.8 mill. in 2020 after reporting NOK 36.2 mill. in operating expenses compared to NOK 28.8 mill. in 2020. The increase reflects the progress in the ongoing clinical trials and are according to plan.

The company had NOK 79.5 million in cash and cash equivalents at the end of the quarter. With the closing of the private placement at the end of the quarter the company also have gross proceeds of NOK 250 mill. that falls due in July. After the private placement the number of common shares in the company are 19 147 215.