On August 6, 2024 Senhwa Biosciences, Inc. (TPEx: 6492), a drug development company focusing on first-in-class therapeutics for oncology, rare diseases, and infectious diseases, reported receipt of a "Study May Proceed" letter from the U.S. Food and Drug Administration ("FDA") for the initiation of a Phase I/II clinical study of Silmitasertib (CX-4945) for the treatment of children and young adults with relapsed refractory solid tumors (Press release, Senhwa Biosciences, AUG 6, 2024, View Source [SID1234645442]).

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The principal investigator of this investigator-initiated trial (IIT), Dr. Giselle Saulnier Sholler, is an internationally known pediatric hematology-oncology clinician and researcher. In August 2023, she was invited to serve as the division chief of Pediatric Hematology and Oncology at Penn State Health Children’s Hospital. She brought with her the Beat Childhood Cancer Research Consortium, a worldwide network of more than 55 universities and children’s hospitals dedicated to discovering new therapies and cures for children with cancer.

The research consortium has enrolled more than 1,800 pediatric cancer patients in more than 23 trials, and has previously helped a drug obtain FDA approval for high-risk relapsed neuroblastoma treatments. This phase I/II study is funded by the Four Diamonds Foundation, with Senhwa Biosciences providing the investigational drug, Silmitasertib (CX-4945).

Senhwa Biosciences is planning to apply for Orphan Drug Designation (ODD) and Rare Pediatric Disease Designation (RPD) for Silmitasertib (CX-4945) for the treatment of neuroblastoma. If these designations are granted and the drug is successfully commercialized, the company would obtain a Priority Review Voucher (PRV). The holder of a PRV can designate any future human drug application to receive priority review, potentially shortening the review time to 6 months, which could accelerate the timeline for the company (or its partners) to bring other products to market.

The clinical trial design also includes Ewing’s sarcoma and osteosarcoma, which are common pediatric bone cancers with poor prognoses, representing unmet medical needs.

On August 6, 2024 Akeso reported the completion of the first patient enrollment in the US for the phase II clinical trial of its innovative CD47 monoclonal antibody, ligufalimab (AK117), in combination with azacitidine for patients with newly diagnosed higher-risk myelodysplastic syndrome (HR-MDS) (Press release, Akeso Biopharma, AUG 6, 2024, View Source [SID1234645441]).

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Preliminary studies show that combining AK117 with azacitidine for treating MDS is safe and significantly effective. In response to the urgent need for new therapies among global MDS patients and the evolving market landscape, Akeso has launched an international multicenter Phase II clinical trial. This initiative aims to expedite AK117’s global approval and commercialization process.

CD47-targeted drug development for treating MDS shows promising potential. AK117, a next-generation humanized IgG4 anti-CD47 antibody, effectively blocks the CD47-SIRPα interaction to enhance phagocytic activity against tumor cells by phagocytes.

Recent data presented at the 65th American Society of Hematology (ASH) (Free ASH Whitepaper) Annual Meeting demonstrated that AK117 combined with azacitidine significantly reduces anemia and transfusion requirements in MDS patients, with favorable safety and notable efficacy. This positions AK117 as a promising treatment option for MDS patients worldwide.

In the United States alone, approximately 40,000 new cases of MDS are diagnosed annually. High-risk MDS patients typically start with azacitidine as standard therapy, but only 20% to 30% achieve complete remission, underscoring significant unmet clinical needs in global MDS treatment.

In addition to ongoing clinical trials for MDS globally, a Phase II study is underway to evaluate AK117 in combination with venetoclax and AZA as frontline therapy for AML patients who are not eligible for intensive chemotherapy.

Akeso is also actively progressing the global market development of AK117 for solid tumors. Multiple clinical trials exploring AK117’s efficacy with other agents, such as PD-1/VEGF bispecific antibodies and PD-1/CTLA-4 bispecific antibodies, are enrolling participants efficiently.

About Ligufalimab (AK117)
AK117, independently developed by Akeso, is a next-generation humanized lgG4 anti-CD47 antibody without hemagglutination effect. AK117 can bind to CD47 expressed on tumor cells and block the interaction between CD47 and SIRPα, to enhance the phagocytic activity of phagocytes on tumor cells, thereby inhibiting the growth of tumors.

Currently, several phase II clinical trials are underway to investigate the potential of AK117 in combination with azacitidine for hematological tumors, as well as AK117 alone or in combination with ivonescimab and cadonilimab for various solid tumors. Preliminary studies have shown promising efficacy and safety profiles, with no observed dose-limiting toxicity events. Additionally, international multicenter clinical studies evaluating AK117 for treating MDS and AML are enrolling patients.

On August 6, 2024 Daiichi Sankyo (TSE: 4568) and Merck (NYSE: MRK), known as MSD outside of the United States and Canada, reported to have expanded their existing global co-development and co-commercialization agreement for three investigational DXd antibody-drug conjugates to include Merck’s MK-6070, an investigational delta-like ligand 3 (DLL3) targeting T-cell engager (Press release, Merck & Co, AUG 6, 2024, https://www.merck.com/news/daiichi-sankyo-and-merck-enter-into-global-development-and-commercialization-agreement-for-mk-6070/ [SID1234645440]). The companies will jointly develop and commercialize MK-6070 worldwide, except in Japan where Merck will maintain exclusive rights. Merck will be solely responsible for manufacturing and supply for MK-6070.

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MK-6070 is a T-cell engager targeting DLL3, an inhibitory canonical Notch ligand that is expressed at high levels in small cell lung cancer (SCLC) and neuroendocrine tumors, currently being evaluated in a Phase 1/2 clinical trial (NCT04471727). The companies are planning to evaluate MK-6070 in combination with ifinatamab deruxtecan (I-DXd) in certain patients with SCLC, as well as other potential combinations. Merck obtained MK-6070 through its acquisition of Harpoon Therapeutics.

"Expanding our oncology pipeline with a DLL3 T-cell engager further supports Daiichi Sankyo’s strategy to create new standards of care for patients with cancer worldwide," said Ken Takeshita, MD, global head, R&D, Daiichi Sankyo. "We look forward to continuing our relationship with Merck with the addition of MK-6070 as it provides potential synergies with our established antibody-drug conjugate collaboration, particularly ifinatamab deruxtecan, and demonstrates our shared commitment to advancing new medicines for patients."

"Small cell lung cancer is an aggressive, fast-growing form of lung cancer and new treatment approaches are urgently needed," said Dr. Dean Y. Li, president, Merck Research Laboratories. "We are pleased to build upon our collaboration with Daiichi Sankyo and look forward to evaluating the novel combination of MK-6070 and ifinatamab deruxtecan in small cell lung cancer and other forms of cancer."

Financial highlights

Under the terms of the agreement, Merck will receive an upfront cash payment of $170 million and has also satisfied a contingent quid obligation from the original collaboration agreement. The companies will share R&D and commercialization expenses as well as profits worldwide, except for Japan where Merck retains exclusive rights and Daiichi Sankyo receives a royalty based on sales. R&D expenses related to MK-6070 in combination with ifinatamab deruxtecan will be shared in a manner consistent with the original agreement for ifinatamab deruxtecan. Merck will generally record sales for MK-6070 worldwide.

About DLL3

Delta-like ligand 3 (DLL3), a Notch inhibitory ligand, is highly expressed on SCLC and other neuroendocrine tumors such as melanoma, small cell bladder cancer and metastatic castration resistant prostate cancer and is minimally expressed in normal tissues. DLL3 is a promising therapeutic target where multiple treatment approaches are being explored.

About MK-6070

MK-6070 is an investigational DLL3 directed tri-specific T-cell engager currently being evaluated in a Phase 1/2 clinical trial as a monotherapy in certain patients with advanced cancers associated with expression of DLL3 and in combination with atezolizumab in certain patients with SCLC. The U.S. Food and Drug Administration (FDA) granted Orphan Drug Designation to MK-6070 for the treatment of SCLC in March 2022.

About the Daiichi Sankyo and Merck collaboration

Daiichi Sankyo and Merck (known as MSD outside of the United States and Canada) entered into a global collaboration in October 2023 to jointly develop and commercialize patritumab deruxtecan (HER3-DXd), ifinatamab deruxtecan (I-DXd) and raludotatug deruxtecan (R-DXd), except in Japan where Daiichi Sankyo will maintain exclusive rights. Daiichi Sankyo is solely responsible for manufacturing and supply.

On August 6, 2024 Zai Lab Limited (NASDAQ: ZLAB; HKEX: 9688) reported financial results for the second quarter of 2024, along with recent product highlights and corporate updates (Press release, Zai Laboratory, AUG 6, 2024, View Source [SID1234645438]).

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"In the second quarter, we achieved impressive commercial growth, maintained financial discipline, and made significant strides across our product portfolio, highlighting our capability to execute on our strategic objectives," said Dr. Samantha Du, Founder, Chairperson, and Chief Executive Officer of Zai Lab. "The success of VYVGART underscores the urgent need for effective and safe treatments for patients living with generalized myasthenia gravis. We will continue to prioritize resources and focus investments on high-value initiatives with the potential to significantly improve human health. Recently, we expanded our global oncology pipeline with a next generation ROR1 ADC program, ZL-6301. Additionally, the progress of our pipeline, including efgartigimod, bemarituzumab, KarXT and our three global clinical-stage assets, keeps us on track to achieve the goals outlined in our five-year strategic plan."

"Our net product revenues grew 45% y-o-y in the second quarter, driven by the successful commercialization of VYVGART," said Josh Smiley, President and Chief Operating Officer of Zai Lab. "In 2024, we will maintain our focus on the strong execution of VYVGART’s launch in generalized myasthenia gravis while also preparing for the anticipated launches of several new products and indications in the near future. Our efforts to build a stronger and more efficient organization, coupled with our innovative pipeline, position us for substantial topline growth and set us on the path to achieve profitability by the end of 2025."

Second-Quarter 2024 Financial Results

•Product revenue, net was $100.1 million in the second quarter of 2024, compared to $68.9 million for the same period in 2023, representing 45% y-o-y growth and 47% y-o-y growth at CER. This increase was primarily driven by increased sales for VYVGART since its launch in September 2023 and China’s National Reimbursement Drug List (NRDL) listing in January 2024, and increased sales for ZEJULA and NUZYRA. Primary drivers of this revenue growth included the following:

–ZEJULA: $45.0 million in the second quarter of 2024, an increase of 5% y-o-y from $43.0 million for the same period in 2023, driven by increased hospital sales in first-line ovarian cancer and increased duration of treatment and supported by the renewal of ZEJULA’s NRDL listing for the maintenance treatment of adult patients with first-line and recurrent ovarian cancer, effective January 1, 2024.

–VYVGART: $23.2 million in the second quarter of 2024, compared to $0.1 million for the same period in 2023, driven by its NRDL listing for the treatment of generalized myasthenia gravis (gMG) effective January 1, 2024 and positive physician and patient reception as well as increased patient access as VYVGART is added to hospital formularies. VYVGART was launched for the treatment of gMG in September 2023.

–NUZYRA: $12.3 million in the second quarter of 2024, an increase of 165% y-o-y compared to $4.6 million for the same period in 2023, driven by the NRDL listings for the IV formulation of NUZYRA for the treatment of adults with community-acquired bacterial pneumonia (CABP) and acute bacterial skin and skin structure infections (ABSSSI) in the first quarter of 2023 and the oral formulation for these indications in the first quarter of 2024.

•Research and Development (R&D) expenses were $61.6 million in the second quarter of 2024, compared to $76.7 million for the same period in 2023. This decrease was primarily due to decreased milestone fees for our license and collaboration agreements, partially offset by increased clinical trial expenses related to newly initiated studies and progress of existing studies.

•Selling, General and Administrative expenses were $79.7 million in the second quarter of 2024, compared to $67.9 million for the same period in 2023. This increase was primarily driven by higher general selling expenses and headcount growth primarily to support VYVGART.

•Net loss was $80.3 million in the second quarter of 2024, or a loss per ordinary share attributable to common stockholders of $0.08 (or loss per American Deposit Share (ADS) of $0.82), compared to a net loss of $120.9 million for the same period in 2023, or a loss per ordinary share of $0.13 (or loss per ADS of $1.25).

•Cash and cash equivalents, short-term investments, and current restricted cash totaled $730.0 million as of June 30, 2024, compared to $750.8 million as of March 31, 2024.

Corporate Updates

Below are key corporate updates since our last earnings release:

•Business Development: In July 2024, Zai Lab entered into a strategic partnership and global license agreement with MabCare Therapeutics. Through this collaboration, the Company expanded its global oncology pipeline with a next generation ADC targeting ROR1, ZL-6301. ZL-6301 has the potential to be used in the treatment of solid tumors where ROR1 is commonly expressed and in hematological malignancies where ROR1 is a validated target. ZL-6301 has demonstrated an encouraging pre-clinical profile, and it is currently in the IND-enabling stage. Zai Lab plans to focus on advancing its global development.

•Organizational Update: In June 2024, Zai Lab appointed Dr. Rafael Amado as President, Head of Global Research and Development, expanding his role to encompass R&D efforts across all of our therapeutic areas upon the retirement of Dr. Harald Reinhart at the end of June. This leadership transition allows for continued momentum and a strategic focus on our pipeline.

Recent Pipeline Highlights

Below are key product updates since our last earnings release:

Oncology Pipeline

•Niraparib (PARP): In July 2024, Zai Lab announced that data of a Zai-supported study published in Cell provides new insights with potential to improve treatment of HRD-positive ovarian cancers, including through neoadjuvant monotherapy with niraparib and a combination of niraparib and ZL-1218, an investigational CCR8 antibody.

•Bemarituzumab (FGFR2b):

•In June 2024, Zai Lab and partner Amgen completed enrollment for the global Phase 3 FORTITUDE-101 study of bemarituzumab plus chemotherapy in first-line gastric cancer.

•The enrollment is ongoing for the global Phase 3 FORTITUDE-102 study of bemarituzumab plus chemotherapy and nivolumab in first-line gastric cancer in mainland China, Hong Kong, Macau, and Taiwan (collectively, Greater China).

•AUGTYRO (Repotrectinib) (ROS1/TRK):

•In May 2024, China’s National Medical Products Administration (NMPA) approved the New Drug Application (NDA) for repotrectinib for the treatment of adult patients with locally advanced or metastatic ROS1-positive NSCLC. The approval was based on the global TRIDENT-1 study that evaluated repotrectinib in TKI naïve and TKI-pretreated patients with ROS1-positive NSCLC. We participated in the Greater China portion of this study.

•In June 2024, Zai Lab partner Bristol Myers Squibb (BMS) announced that the U.S. Food and Drug Administration (FDA) had granted accelerated approval of AUGTYRO for the treatment of patients with NTRK-positive locally advanced or metastatic solid tumors.

•ZL-1310 (DLL3 ADC): The enrollment in the United States and Greater China is ongoing for the global Phase 1 study in relapsed and refractory second-line+ small cell lung cancer (SCLC) who have progressed on or after platinum-based chemotherapy.

•ZL-1218 (CCR8): The enrollment in the United States, Europe, and Greater China is ongoing for the global Phase 1 study of ZL-1218 as a single agent and in combination with pembrolizumab in patients with advanced solid tumor malignancies.

Immunology, Neuroscience, and Infectious Disease Pipeline

•Efgartigimod (FcRn):

•In July 2024, the NMPA approved the Biologics License Application (BLA) for efgartigimod alfa injection (subcutaneous injection) (efgartigimod SC) as an add on to standard therapy for the treatment of adult patients with gMG who are anti-acetylcholine receptor (AChR) antibody positive. This approval will provide additional flexibility and optionality for gMG patients in mainland China.

•In May 2024, the NMPA accepted the supplemental Biologics License Application (sBLA) with priority review for efgartigimod SC in chronic inflammatory demyelinating polyneuropathy (CIDP). In June 2024, Zai Lab partner argenx announced that the FDA approved VYVGART Hytrulo (efgartigimod alfa and hyaluronidase-qvfc) for this indication. We participated in the global ADHERE Study, the largest clinical trial to date studying CIDP.

•XACDURO (Sulbactam-Durlobactam or SUL-DUR): In May 2024, the NMPA approved the NDA for XACDURO for the treatment of adult patients with hospital-acquired bacterial pneumonia and ventilator-associated bacterial pneumonia (HABP/VABP) caused by susceptible isolates of Acinetobacter baumannii-calcoaceticus complex.

•Xanomeline-Trospium (KarXT) (M1/M4-agonist): In July 2024, Zai Lab joined the global Phase 3 ADEPT-2 study in Alzheimer’s disease with psychosis in Greater China.

•ZL-1102 (IL-17 Humabody): In May 2024, Zai Lab dosed the first patient in a global Phase 2 study evaluating the efficacy and safety of ZL-1102 for the treatment of chronic plaque psoriasis (CPP).

Anticipated Major Milestones in 2024 and the First Half of 2025

Potential Regulatory Submissions to the NMPA

•TTFields: Marketing Authorization Application (MAA) submission in second-line+ NSCLC following progression on or after platinum-based chemotherapy in the fourth quarter of 2024.

•Tisotumab Vedotin (Tissue Factor ADC): BLA submission in recurrent or metastatic cervical cancer following progression on or after chemotherapy.

•Repotrectinib (ROS1/TRK): supplementary NDA (sNDA) submission in NTRK+ solid tumors.

•Xanomeline-Trospium (KarXT) (M1/M4-agonist): NDA submission in schizophrenia.

Expected Clinical Development and Data Readouts

Efgartigimod (FcRn)

•Zai Lab to join the registrational study of efgartigimod SC given by prefilled syringe in Thyroid Eye Disease (TED) in Greater China in the fourth quarter of 2024.

•argenx to provide topline data from the Phase 2/3 ALKIVIA study evaluating efgartigimod across three myositis subsets (immune-mediated necrotizing myopathy (IMNM), anti-synthetase syndrome (ASyS), and dermatomyositis (DM)) in the fourth quarter of 2024. Zai Lab to join the Phase 3 portion of this study in the fourth quarter of 2024.

•Zai Lab to join the global registrational Phase 3 studies in seronegative gMG and ocular MG in early 2025, aiming to expand the label into broader MG populations.

Xanomeline-Trospium (KarXT) (M1/M4-agonist)

•Zai Lab to complete patient enrollment of the China registrational bridging study in schizophrenia, with topline data expected by the end of 2024.

•BMS to report data from the EMERGENT-4 and EMERGENT-5 trials evaluating the long-term safety for treatment of schizophrenia in the second half of 2024.

TTFields

•Novocure to provide a topline data readout from the Phase 3 PANOVA-3 clinical trial in locally advanced pancreatic cancer in the fourth quarter of 2024. We are participating in the study in Greater China.

ZL-1310 (DLL3 ADC)

•Potential dose escalation data from the global Phase 1 study in relapsed and refractory second-line+ SCLC at the end of 2024 or early 2025.

ZL-1218 (CCR8)

•Present the preliminary clinical PK and PD analysis of the global Phase 1 study in solid tumors at 2024 European Society for Medical Oncology (ESMO) (Free ESMO Whitepaper) in September 2024.

Conference Call and Webcast Information

Zai Lab will host a live conference call and webcast tomorrow, August 7, 2024, at 8:00 a.m. ET (8:00 p.m. HKT). Listeners may access the live webcast by visiting the Company’s website at View Source Participants must register in advance of the conference call.

Details are as follows:

Registration Link: https://register.vevent.com/register/BIaccafead4b094cf191720bf5d03048c6

All participants must use the link provided above to complete the online registration process in advance of the conference call. Dial-in details will be in the confirmation email which the participant will receive upon registering.

A replay will be available shortly after the call and can be accessed by visiting the Company’s website.

On August 6, 2024 Veracyte, Inc. (Nasdaq: VCYT) reported financial results for the second quarter ended June 30, 2024 (Press release, Veracyte, AUG 6, 2024, View Source [SID1234645437]).

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"Our exceptional second quarter results are a testament to the strength and robustness of Decipher and Afirma," said Marc Stapley, Veracyte’s chief executive officer. "With both tests clearly gaining share in their respective markets and plenty of headroom for durable future expansion, our confidence in their long-term prospects continues to grow. Meanwhile, our positive cash generation and class-leading profitability profile are fueling a portfolio of tests that are poised to drive meaningful advances in precision medicine."

Key Business Highlights
•Increased second quarter total revenue by 27%, to $114.4 million, compared to the second quarter of 2023.
•Grew total test volume to 39,023, an increase of 23% compared to the second quarter of 2023.
•Increased second quarter net income to $5.7 million and delivered adjusted EBITDA of $24.0 million, or 21% of revenue.
•Achieved record Decipher Prostate test volume of close to 19,900 tests, driven by recently updated NCCN* prostate cancer guidelines, in which the Decipher Prostate test received the highest-level rating among gene expression tests.
•Delivered record Afirma test volume of approximately 15,700 and received Medicare coverage for Afirma testing of patients with thyroid nodules classified as "Bethesda V," giving more patients annually access to the test.
•Reinforced Veracyte’s commitment to evidence expansion with three published Decipher Prostate test studies, including a real-world, population-based analysis of Decipher data linked to the National Cancer Institute’s SEER database demonstrating the test’s clinical utility and underscoring the power of the Veracyte Diagnostics Platform.
•Generated $26.7 million of cash during the second quarter to end the quarter with $235.9 million of cash and cash equivalents.

* National Comprehensive Cancer Network. NCCN makes no warranties of any kind whatsoever regarding their content, use or application and disclaims any responsibility for their application or use in any way.

A reconciliation of GAAP to non-GAAP financial measures has been provided in the tables included in this press release. An explanation of these measures is also included below under the heading "Note Regarding Use of Non-GAAP Financial Measures."

Second Quarter 2024 Financial Results

Total revenue for the second quarter of 2024 was $114.4 million, an increase of 27% compared to $90.3 million reported in the second quarter of 2023. Testing revenue was $107.0 million, an increase of 31% compared to $81.7

million in the second quarter of 2023, driven by the strong performance of our Decipher Prostate and Afirma tests. Product revenue was $3.9 million, a decrease of 3% compared to $4.0 million in the second quarter of 2023. Biopharmaceutical and other revenue was $3.6 million, a decrease of 22% compared to $4.6 million in the second quarter of 2023.

Total gross margin for the second quarter of 2024 was 68%, compared to 62% in the second quarter of 2023. Non-GAAP gross margin, which excludes the amortization of acquired intangible assets, stock-based compensation, other acquisition related expenses, and certain other adjustments was 71%, compared to 68% in the second quarter of 2023.

Operating expenses were $73.3 million for the second quarter of 2024. Non-GAAP operating expenses, which excludes amortization of acquired intangible assets, stock-based compensation, other acquisition related expenses, and other restructuring costs, grew 14% to $59.0 million compared to $51.7 million in the second quarter of 2023.

Net income for the second quarter of 2024 was $5.7 million, an improvement of 168% compared to the second quarter of 2023. Basic and diluted net earnings per common share was $0.07, an improvement of $0.19 compared to the second quarter of 2023. Non-GAAP diluted net earnings per common share was $0.30, an improvement of $0.18 compared to the second quarter of 2023. Net cash provided by operating activities in the first six months of 2024 was $20.6 million, an improvement of $6.1 million compared to the same period in 2023.

Adjusted EBITDA for the second quarter of 2024 was $24.0 million, an improvement of 118% compared to the second quarter of 2023, representing 21% of revenue compared to 12% of revenue respectively.

A reconciliation of GAAP to non-GAAP financial measures has been provided in the tables included in this press release. An explanation of these measures is also included below under the heading "Note Regarding Use of Non-GAAP Financial Measures."

2024 Financial Outlook

The company is raising full-year 2024 total revenue guidance to $432 million to $438 million, representing year-over-year growth of 20% to 21% and testing revenue growth of approximately 25%. This guidance range represents an increase compared to prior guidance of $402 million to $410 million. In addition, the company now expects cash, cash equivalents and short-term investments at the end of the year to be $260 million to $270 million compared to prior guidance of $236 million to $240 million.

Conference Call and Webcast Details

Veracyte will host a conference call and webcast today at 4:30 p.m. Eastern Time to discuss the company’s financial results and provide a general business update. The conference call will be webcast live from the company’s website and will be available via the following link: View Source The webcast should be accessed 10 minutes prior to the conference call start time. A replay of the webcast will be available for one year following the conclusion of the live broadcast and will be accessible on the company’s website at View Source

The conference call dial-in can be accessed by registering at the following link: https://register.vevent.com/register/BIbb7f6b70b4ce4820b6391059390d6139