On November 17, 2022 Novocure (NASDAQ: NVCR) reported 25 abstracts on Tumor Treating Fields (TTFields) therapy will be featured at the Society for Neuro-Oncology (SNO) 2022 Annual Meeting from Nov. 16 to Nov. 20 in Tampa (Press release, NovoCure, NOV 17, 2022, View Source [SID1234624215]). The presentations cover a broad range of topics, including TTFields’ multimodal mechanism of action, safety and tolerability, and health economics and outcomes research (HEOR).

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"We are honored and proud of the volume and depth of TTFields research featured at the SNO 2022 Annual Meeting"

New research in HEOR includes an analysis by a coalition of researchers at Central Brain Tumor Registry of the United States (CBTRUS), Duke University and the National Cancer Institute that utilized commercial claims and population-based datasets to better understand potential treatment factors associated with improved survival for glioblastoma (GBM) (Corey Neff, M.P.H., Department of Neurosurgery, Duke University School of Medicine in Durham, North Carolina, et al.) The presentation, "Improvements in survival for glioblastoma in the post-Stupp protocol era," showed that survival in GBM has continued to improve over time in the post-Stupp protocol era, which may be due to developments of new therapeutic approaches. The analysis showed post-Stupp therapeutic developments, including TTFields, significantly increase overall survival in the commercially insured population. Of the 19,414 identified adult patients with GBM, 3,061 used TTFields therapy. These patients experienced an extended median overall survival compared to patients who were not treated with TTFields (17.6 months versus 13.1 months, respectively; hazard ratio: 0.77; P<0.001).

A presentation by Maciej M. Mrugala, M.D., Ph.D., M.P.H., Director of the Neuro-Oncology Program at the Mayo Clinic College of Medicine and Science in Phoenix, analyzed post-market safety data from more than 23,000 high-grade glioma patients who received TTFields therapy in the last decade, representing the largest safety dataset to date. These global real-world data reinforced the findings from our EF-14 phase 3 pivotal study that TTFields therapy is well-tolerated in GBM patients, with no new safety signals identified. There were no observed differences by type of GBM diagnoses and by age subgroups. These data are consistent with previous findings in that TTFields therapy is not associated with added systemic toxicity; localized skin irritation is the most common adverse event and can be managed with appropriate prophylaxis and treatment strategies.

A presentation highlighting TTFields therapy as a treatment for newly diagnosed GBM includes the first results of the PriCoTTF phase 1/2 study, which met its primary endpoint demonstrating the safety and tolerability of TTFields concomitant with radiotherapy, presented by Sied Kebir, M.D., Deputy Head of the Division of Clinical Neurooncology at University Medicine Essen in Germany.

Josef Vymazal, M.D., Deputy Director of Na Homolce Hospital in Prague, will present data from 18 years of clinical practice experience with newly diagnosed GBM patients. Patients who received TTFields therapy demonstrated improvements in progression free survival and overall survival compared to controls (hazard ratio: 0.55, P=0.006; and 0.61, P=0.027 respectively). This is one of several extensive studies assessing survival outcomes in newly diagnosed GBM patients treated with TTFields therapy conducted at a single center to date.

"We are honored and proud of the volume and depth of TTFields research featured at the SNO 2022 Annual Meeting," said Frank Leonard, President of Novocure’s U.S. CNS (central nervous system) Cancers Franchise. "Over the last 15 years, SNO has been an important meeting for Novocure as Tumor Treating Fields therapy has become ingrained within the neuro-oncology community and as our science continues to evolve. We look forward to gathering and participating in this essential scientific exchange for the advancement of neuro-oncology."

ABSTRACTS

All poster presentations will occur from 7:30 p.m. to 9:30 p.m. EST Friday, Nov. 18, in West/Central Hall.

CLINICAL STUDIES

(INNV-10) Overcoming challenges and optimizing patient outcomes with Tumor Treating Fields (TTFields) therapy. Lead author and presenter: P. Gage Gwyn.

(INNV-07) Tumor Treating Fields (TTFields; 200 kHz) post-marketing safety data from patients with glioblastoma treated between 2011–2022. Lead author and presenter: Maciej M. Mrugala.

(INNV-11) Eighteen Years of Experience with Treatment of Glioblastoma Using Tumor Treating Fields (TTFields) in Newly Diagnosed Glioblastoma (ndGBM) in a single center. Lead author and presenter: Josef Vymazal.

(NCOG-22) TIGER PRO-Active Study: Investigating daily activity, sleep and neurocognitive functioning in glioblastoma patients applying TTFields therapy in Germany in Routine Clinical Care. Lead author: Martin Glas. Presenter: Sied Kebir.

(RADT-17) A case of recurrent glioblastoma effectively treated with tumor-treating-fields. Lead author and presenter: Xin Geng.

(INNV-22) A case report of multiple lesions disappearing after TMZ+TTFields+ Darafenib and trametinib in a patient with GBM. Lead author and presenter: Boning Cai.

(INNV-30) Retrospective analysis of TTFields in patients with HGG based on the criteria of 2021 WHO CNS5. Lead author: Xiaoyan Yang. Presenter: Feng Wang.

(RADT-18) Particle Beam Radiation Therapy plus Tumor Treating Fields in the Treatment of Newly Diagnosed WHO Grade 4 Gliomas: An Early Result of Phase 2 Single-arm Trial. Lead author and presenter: Xianxin Qiu.

(CTNI-47) Tumor Treating Fields Combine with Temozolomide for Newly Diagnosed Glioblastoma: A Retrospective Analysis of Chinese Patients. Lead author: Chunjui Chen. Presenter: Zhiyong Qin.

(CTIM-05) Final results of 2-THE-TOP: a pilot phase 2 study of TTFields (Optune) plus pembrolizumab plus maintenance temozolomide (TMZ) in patients with newly diagnosed glioblastoma (ndGBM). Lead author and presenter: David D. Tran. (Abstract only)

(CTNI-29) Investigating safety and efficacy of TTFields prior and concomitant to radiotherapy in newly diagnosed glioblastoma – first results of the PriCoTTF phase I/II trial. Lead author: Martin Glas. Presenter: Sied Kebir.

(INNV-09) Impact of Molecular markers on treatment outcome of Glioblastoma patients treated with concurrent Tumor-Treating Fields (TTF) and chemoradiation: secondary analysis of SPARE trial. Lead author and presenter: Louis Cappelli.

(RADT-19) Chemoradiation (CRT) treatment with or without concurrent Tumor-Treating Fields (TTFields) in patients with newly diagnosed glioblastoma (GBM). Lead author and presenter: Louis Cappelli.

PRECLINICAL STUDIES

(CSIG-41) Sensitizing cancer cells to Tumor Treating Fields (TTFields) by Inhibition of PI3K. Lead author: Anat Klein-Goldberg. Presenter: Moshe Giladi.

(DNAR-10) The efficacy of temozolomide and lomustine in glioblastoma cell lines may be enhanced by concomitant treatment with Tumor Treating Fields (TTFields). Lead author: Hila Fishman. Presenter: Moshe Giladi.

(EXTH-72) TTFields enhance the antineoplastic activity of the drug-repurposing approach CUSP9v3 in glioblastoma in vitro. Lead author: Qiyu Cao. (Abstract only)

(CCRG-04) Targeting the cell-cycle effects of Tumor Treating Fields (TTFields) to increase its efficacy. Lead author: Paul L.G. Slangen. Presenter: Gerben R. Borst.

(DNAR-12) Combining Tumour Treating Fields with therapeutic DNA damage response inhibitors to increase potency in high-grade glioblastomas using clinically relevant ex-vivo glioma stem cell models. Lead author: Aurelie Vanderlinden. Presenter: Ola Rominiyi.

INNOVATION

(MODL-07) Sensitivity of Tumor Treating Fields (TTFields) treatment planning to tumor segmentation errors. Lead author: Oshrit Ze’evi. Presenter: Eyal Abend.

(MODL-13) Sensitivity of Tumor Treating Fields (TTFields) treatment planning to healthy tissue segmentation inaccuracies. Lead author: Oshrit Ze’evi. (Abstract only)

(MODL-21) Efficacy of different layouts in treating infratentorial tumors with Tumor Treating Fields (TTFields). Lead author: Ariel Naveh. (Abstract only)

(EXTH-05) Toward 100% clinical efficacy for tumor-treating fields. Lead author and presenter: Kristen W. Carlson.

(NIMG-69) Prediction of Progression-Free Survival in Patients with Primary Glioblastoma: MRI T2 Relaxivity and Deep Learning. Lead author and presenter: Aaron Rulseh

HEALTH ECONOMICS AND OUTCOMES RESEARCH

(QOL-21) Real-world quality-of-life and health utilities for patients with CNS cancers on the XCELSIOR platform. Lead author: Sarah Ginn. Presenter: Gordon V. Chavez.

(EPID-06) Improvements in survival for glioblastoma in the post-Stupp protocol era. Lead author: Corey Neff. Presenter: Quinn T. Ostrom.

On November 17, 2022 Universal Diagnostics (Universal DX), a bioinformatics and multi-omics company on a mission to transform cancer into a curable disease, reported the results of a study evaluating putative methylation markers in biological context of early colorectal cancer (CRC) development (Press release, Universal Diagnostics, NOV 17, 2022, View Source [SID1234624214]).

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Universal DX has previously shown that non-invasive blood testing can be used to detect CRC and pre-cancerous advanced adenomas (AA) through both analysis of cell-free circulating tumor DNA (ctDNA) methylation, fragmentation and microbiome patterns with single targeted sequencing analysis and combining it with advanced computational biology and machine learning algorithms.

Today’s news is the latest in a series of findings from Universal DX, extending early-stage colorectal cancer detection to prognostics and stratification, which could lead to better outcomes and improved survival rates.

"This newest study underscores the robustness and validity of our previous results, by adding more biological value to the individual methylation marker regions," said Christian Hense, COO at Universal DX. "Investigating their impact on gene expression and putting these biomarkers in the context of biological pathways allows for better understanding of the behavior of early cancer. Extending early detection potential of the markers to further prognostics and stratification could lead to improved survival outcomes of the patients as well as potentially serve as interesting new treatment targets in the future. Every step in our research gets us closer to a day where cancer is a curable disease and we can save more lives."

Study results:

Differential signal was observed between AA and NAT and CRC and adjacent normal tissue, indicating biological signal change with adenoma progression to cancer.
Hierarchical clustering identified 3 distinct classes of patients based on methylation levels.
KEGG pathway analysis revealed that the top pathways involved were axonal guidance, ephrin receptor signaling, epithelial-mesenchymal transition and FGF signaling, all which play a significant role in the context of cancer development and progression.
Correlation of methylation signal to transcriptomics data from The Cancer Genome Atlas (TCGA) COAD and READ cohorts showed significant correlation to dysregulation of the gene expression, indicating the functional relevance of the gene methylation.
Targeted methylation sequencing on plasma samples of patients with early stage (I-IIA) colorectal cancer (26 patients from Ukraine and Germany) and age and gender matching colonoscopy-verified controls (from same cohort), showed high individual marker accuracy with AUC > 0.73.
Kaplan-Meier analysis showed significant correlation to patients’ 5- year survival prediction linked to 3 genes: FGF14 (p=0.025, HR = 1.75), DPY19L2P1 (p=0.012, HR = 1.86), PTPRO (p=0.046, HR = 1.63).
Universal DX leverages proprietary, state-of-the-art computational biology tools combined with a targeted next generation sequencing assay platform that allows for simultaneous detection of methylation, fragmentation and microbiome signals for highly-sensitive cancer signal scoring of cell-free DNA regions linked to cancer of interest.

Hense continued: "CRC is one of the deadliest cancers in the United States. The current methods of biomarker-based tests to screen for CRC are still extremely limited. At Universal DX, we are on a mission to find new and better methods. We know early detection is one of the most powerful tools for improving survival rates, so identifying these markers could be the next step towards earlier – and easier – detection."

Universal DX will present its findings live at the AACR (Free AACR Whitepaper) special conference on Precisions, Prevention, Early Detection, and Interception of Cancer in Austin, TX November 17-19.

On November 17, 2022 RenovoRx, Inc. (Nasdaq: RNXT), a biopharmaceutical company focused on the localized treatment of difficult-to-treat solid tumors through its proprietary RenovoRx Trans-Arterial Micro-Perfusion (RenovoTAMP) therapy platform, reported RenovoTAMP was highlighted in two presentations delivered at the Advanced Interventional Management Symposium (AIMsymposium) (Press release, Renovorx, NOV 17, 2022, View Source [SID1234624213]). RenovoTAMP is a unique therapy platform designed for targeted intra-arterial (IA) delivery of chemotherapy directly to tumors. This symposium was the 30th annual AIMsymposium and is being held November 14-17, 2022 at the New York Hilton.

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Presentations included:

Dr. Ripal Gandhi, Professor of Interventional Radiology at the Miami Cancer Institute and Miami Cardiac and Vascular Institute, presented "Advances in the Management of Pancreatic Cancer," and provided an overview of the clinical challenges of the standard-of-care treatment available to locally advanced pancreatic cancer (LAPC) patients. Systemic intravenous (IV) chemotherapy is considered the standard of care for LAPC and is often associated with debilitating side effects and may be ineffective in treating this type of cancer due to tumors lacking dedicated blood vessels critical for delivering chemotherapy.

Dr. Gandhi highlighted the RenovoTAMP therapy platform’s potential as a targeted oncology option for LAPC patients. The presentation reviewed RenovoRx’s RR1 Phase I/II and RR2 Observational Registry studies and RenovoTAMP’s potential to increase chemotherapy delivery directly to the tumor to increase survival and reduce systemic toxicity. Dr. Gandhi also presented the mission and protocol behind the TIGeR-PaC study.

The Phase III TIGeR-PaC study is evaluating RenovoRx’s first product candidate, RenovoGem, to treat LAPC through RenovoTAMP’s intra-arterial delivery of gemcitabine, an FDA-approved chemotherapy. Study goals include the extension of patient survival, reduction of side effects associated with systemic chemotherapy, and improved quality of life for pancreatic cancer patients.

Dr. Christopher Laing, an interventional radiologist at Sutter Medical Group, presented "Animal Studies Using a Double-Balloon Catheter Leads to Interesting Discoveries Regarding the Mechanism of Chemoperfusion for Pancreatic Cancer." Dr. Laing’s presentation discusses how RenovoTAMP and its potential benefits can be better described and optimized based on important scientific findings using animal models. For example, while some investigators have demonstrated interest in forcing chemotherapy across the wall of the bile duct for the treatment of bile duct cancer, Dr. Laing describes animal experiments that demonstrate challenges to this approach. Dr. Laing further highlights the potential for RenovoTAMP in the bile duct patient population, similar to its use in pancreatic cancer therapy. Dr. Laing also discusses recent discoveries on how the drugs may traverse through the wall of the major blood vessels adjacent to the tumor to make RenovoTAMP work which could also pave the way for expanding the therapy platform to a wide array of therapeutic agents, even beyond small molecule chemotherapeutics.
"The AIMsymposium is an insightful conference that focuses on current issues and new techniques in interventional radiology and endovascular therapy," said Ramtin Agah, M.D., Chief Medical Officer and Founder of RenovoRx. "We appreciate both Dr. Gandhi and Dr. Laing highlighting our therapy platform and its potential treatment option for patients diagnosed with difficult-to-treat cancers, like pancreatic and bile duct tumors."

Dr. Agah added, "These presentations emphasize our team’s tremendous focus on refining RenovoTAMP as a potential, more targeted therapy for difficult-to-treat cancers. Results of our studies to date suggest that utilizing approved chemotherapeutics with validated mechanisms of action and well-established safety and side effect profiles via RenovoTAMP has the potential to increase their efficacy, improve safety, and widen therapeutic windows. We continue to push the understanding of the science behind our success. Our research has identified one of the major barriers to therapeutic success in the pancreatic cancer setting: these types of tumors do not have sufficient blood vessels that would normally deliver chemotherapy. The RenovoTAMP therapy may overcome that barrier by using pressure to force chemotherapy into the tissue."

About the Phase III TIGeR-PaC Clinical Trial

TIGeR-PaC is a randomized multi-center Phase III study using RenovoRx’s innovative therapy platform, RenovoTAMP (RenovoRx Trans-Arterial Micro-Perfusion). The study is evaluating the Company’s first product candidate, RenovoGemTM, to treat locally advanced pancreatic cancer (LAPC) through the intra-arterial delivery of gemcitabine (FDA-approved chemotherapy). The study has a primary endpoint of overall survival and several secondary endpoints, including quality of life.

TIGeR-PaC is currently enrolling unresectable LAPC patients at several sites across the US. To learn more about the study and the participating clinical trial sites, visit View Source

On November 17, 2022 Bavarian Nordic A/S (OMX: BAVA) reportes the signing of a joint procurement agreement with HERA, the European Commission’s Health Emergency Preparedness and Response Authority for the supply of up to 2 million doses of the Company’s MVA-BN monkeypox vaccine during 2023 and 2024 (Press release, Bavarian Nordic, NOV 17, 2022, View Source [SID1234624212]).

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The joint procurement agreement allows EU Member States and additional countries in the European Economic Area (EEA) as well as Western Balkan countries to purchase Bavarian Nordic’s monkeypox vaccine. So far, 14 eligible countries have already confirmed their participation in the joint procurement, indicating an initial demand of a total of approximately 700,000 doses for delivery in 2023 under the framework contract.

Since June 2022, HERA has purchased more than 330,000 doses of the vaccine which are being distributed to EU Member States throughout 2022 in response to the current monkeypox outbreak. The likelihood of monkeypox spreading further in at-risk communities is still high and the new joint procurement agreement will ensure that countries remain prepared to tackle the outbreak beyond this year.

Paul Chaplin, President and CEO of Bavarian Nordic said: "We are pleased to strengthen our collaboration with the EU authorities and others on securing the continued preparedness against monkeypox across Europe. While more and more countries have started to recognize the need for building a stockpile for the longer term, most EU Member States continue to rely on the availability of the vaccine through HERA, and this joint procurement agreement will help to reinforce the response across the entire region."

About HERA
The European Health Emergency Preparedness and Response Authority (HERA) was established by the European Commission in September 2021 with the purpose to strengthen Europe’s ability to prevent, detect, and rapidly respond to cross-border health emergencies, by ensuring the development, manufacturing, procurement, and equitable distribution of key medical countermeasures.

About the monkeypox vaccine
MVA-BN or Modified Vaccinia Ankara-Bavarian Nordic (marketed as IMVANEX in Europe, JYNNEOS in the U.S. and IMVAMUNE in Canada) is a non-replicating smallpox vaccine developed in collaboration with the U.S. government to ensure supply of a smallpox vaccine for the entire population, including immunocompromised individuals who are not recommended vaccination with traditional replicating smallpox vaccines. In addition to smallpox, the U.S. Food and Drug Administration, Health Canada and the European Commission have also approved the vaccine for use against monkeypox as the only vaccine having obtained this to-date.

Bavarian Nordic has ongoing supply contracts with USA and Canada and has delivered the vaccine to a number of undisclosed countries globally as part of their national biological preparedness. During the ongoing 2022 outbreak of monkeypox, Bavarian Nordic has worked with multiple governments and supranational organizations to ensure rapid access to the vaccine in more than 70 countries to-date and is working to expand its manufacturing capacity to fulfil the global demand in the medium- to long term.

On November 17, 2022 Rakovina Therapeutics Inc. (TSX-V: RKV, the "Company") a biopharmaceutical company committed to advancing new cancer therapies based on novel DNA-damage response technologies reported the financial results for the quarter ended September 30, 2022 and provided a corporate update (Press release, Rakovina Therapeutics, NOV 17, 2022, View Source,September%2030%2C%202022%2C%20respectively. [SID1234624211]).

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Corporate Update

Rakovina Therapeutics has continued to communicate progress in the Company’s research and development programs through presentations at peer-reviewed scientific meetings and publications:

On October 31, 2022, the Company announced our presentation at the 34th Annual AACR (Free AACR Whitepaper)-NCI-EORTC Molecular Targets and Cancer Therapeutics Symposium;
On November 14, 2022, the Company announced the preprint publication of a manuscript entitled ‘A bi-functional PARP-HDAC inhibitor with activity in Ewing sarcoma’. The manuscript reports research results of our kt-3000 dual PARP-HDAC inhibitor drug candidate in HR-proficient Ewing sarcoma models.
"Our data support advancing lead compounds from our kt-3000 PARP-HDAC inhibitor series as a novel approach in the treatment of Ewing sarcoma," stated Prof. Mads Daugaard Rakovina Therapeutics’ president and chief scientific officer. "This concept will likely be relevant in the treatment of cancer indications beyond Ewing sarcoma and potentially offer an opportunity to overcome therapeutic resistance to PARP-inhibitor treatment."

Rakovina Therapeutics’ kt-3000 series is a novel class of bi-functional small-molecule drug candidates that has been designed to combine inhibition of both poly(ADP)-ribose polymerase (PARP) and histone deacetylase (HDAC) in a single molecule as a novel approach to providing meaningful clinical benefit to cancer patients.

Data presented demonstrate that the kt-3000 prototype lead compound performs 30-40 times better than the FDA-approved PARP inhibitor olaparib (Lynparza) and 5-10 times better than the FDA-approved HDAC-inhibitor vorinostat (Zolina) in Ewing sarcoma 3D spheroid models. In an Ewing sarcoma metastasis model, a kt-3000 drug candidate prevented metastatic cancer growth in the lungs of mice inoculated with an aggressive Ewing sarcoma cell line. The Company believes that these data provide proof-of-concept validation of kt-3000 drug candidates to address significant unmet needs in the treatment of Ewing sarcoma and other solid tumors.

Ewing sarcoma is a cancer that occurs primarily in the bone or soft tissues and is the second most common type of bone cancer affecting children and young adults. The development of new and improved treatments for Ewing sarcoma represents a significant unmet medical need. Approximately thirty percent of patients will experience recurrence within five years following treatment. The prognosis for patients with recurrent or progressive Ewing sarcoma is poor with average survival from the time of relapse of only 14 months.

A kt-3000 series drug candidate for the treatment of recurrent Ewing sarcoma may qualify for an FDA priority review voucher. Under this program, a sponsor who receives an approval for a drug or biologic for a "rare pediatric disease" may qualify for a voucher that can be redeemed to receive a priority review of a subsequent marketing application for a different product.

If received, a priority review voucher could be used to accelerate the regulatory review of another Rakovina Therapeutics drug candidate or it could be sold to a third party. During 2022, multiple companies sold priority review vouchers at prices ranging from US$100 million to US$110 million.

"Based on our progress to date, we are confident that we may be in a position to file regulatory documentation to begin human clinical trials with a kt-3000 series drug candidate in the second half of 2023," stated Prof. Daugaard. "Because early-stage clinical trials in the cancer field are often ‘open label’, we will have the opportunity to report continued progress of our future clinical trials at peer-reviewed scientific meetings."

The Company also reported continued progress within its other research programs.

kt-2000 series drug candidates are being optimized to achieve PARP-1 selectivity and therapeutically relevant brain penetration. Recent research has suggested an improved safety profile for PARP-1 selective compounds vs. PARP-1/2 inhibitors.

Currently, the four FDA-approved PARPi are all PARP-1/2 inhibitors with limited brain penetration. Rakovina Therapeutics believes that a PARP-1 selective brain-penetrant drug candidate from our kt-2000 series will provide attractive opportunities to establish collaborations with leading pharmaceutical companies.
kt-4000 series drug candidates combine a targeted DNA-damaging functionality with potent PARP inhibition in a single molecule. Earlier this year, the Company presented data at the American Association of Cancer Research Annual Meeting demonstrating that treatment with kt-4000 series candidates leads to G2/M cell cycle arrest and cell death in HR-proficient cancer cells, normally resistant to PARP inhibitor treatment.
Summary Financial Results for the quarter ended September 30, 2022

The Company commenced operations on March 25, 2021, concurrent with the closing of the qualifying transaction with Vincero Capital Corp. and began trading on the Toronto Venture Exchange under the symbol RKV on April 1, 2021. At September 30, 2022, the Company had positive working capital of approximately $1.4 million.

For the three and nine months ended September 30, 2022, the Company reported a net loss of $715,880 and $2,143,808 respectively. Research and development expenses were $541,447 and $1,427,949 for the three and nine months ended September 30, 2022, respectively. General and administrative expenses were $185,903 and $736,671 for the three and nine months ended September 30, 2022, respectively. Total cash expenses related to research and development and general and administrative expenses for the three months ended September 30, 2022 were $529,462.