A Multicenter, Randomized, Double-blind, Placebo-controlled Study of Enzastaurin for the Prevention of Arterial Events in Patients With Vascular Ehlers-Danlos Syndrome (vEDS) Confirmed With COL3A1 Mutations, Followed by an Open Label Extension (OLE)

The purpose of this study is to investigate the efficacy of enzastaurin compared to placebo in preventing arterial events (rupture, dissection, pseudoaneurysm, carotid-cavernous sinus fistula, or aneurysm, fatal or not) leading to intervention or mortality attributable to an arterial event in patients with vEDS confirmed with pathogenic heterozygous COL3A1 gene mutations predicted to derive a mutant protein.

Start Date01 Jan 2025

Sponsor / Collaborator

Aytu Biopharma, Inc.

[+1]

EUCTR2021-006574-23-BE / Unknown statusPhase 3

A multicenter, randomized, double-blind, placebo-controlled study of enzastaurin for the prevention of arterial events in patients with vascular Ehlers-Danlos Syndrome (vEDS) confirmed with COL3A1 mutations, followed by an open label extension (OLE) - PREVEnt (Prevention of Rupture with Enzastaurin in Vascular Ehlers-Danlos Syndrome Trial)

Start Date20 Jun 2022

Sponsor / Collaborator

Aytu Biopharma, Inc.

CTR20210055 / CompletedPhase 3

在新诊断为胶质母细胞瘤并且全新生物标记物DGM1 阳性患者中评估Enzastaurin联合替莫唑胺同步放化疗加辅助化疗方案的随机双盲安慰剂对照III期临床试验

[Translation] A randomized, double-blind, placebo-controlled phase III trial evaluating Enzastaurin combined with temozolomide concurrent chemoradiotherapy plus adjuvant chemotherapy in patients with newly diagnosed glioblastoma and positive for the novel biomarker DGM1

主要目的：在新诊断为胶质母细胞瘤的Denovo基因标记物1（DGM1）阳性患者中，与安慰剂对照，评估enzastaurin联合替莫唑胺同步放化疗加辅助化疗方案在患者总生存期（OS）方面的优效性。次要目的： 1. 在DGM1生物标记物阳性患者中比较治疗组间的无进展生存期（PFS）。 2. 在DGM1生物标记物阳性患者中比较治疗组间的客观缓解率（ORR）。 3. 进一步评估enzastaurin加入替莫唑胺同步放化疗加辅助化疗方案后的安全性特征。探索性目的： 1. 在DGM1生物标记物阴性患者中评估总生存期（OS）。 2. 确定色素尿的存在（尿液呈橙色/红色）是否与服用enzastaurin的患者生存期改善存在关联。 3. 分析尿液中是否存在enzastaurin和enzastaurin代谢产物（尿液药代动力学[PK]）。 4. 评估其它胚系或肿瘤生物标记物的存在是否与服用enzastaurin的患者的疗效改善存在关联。 5. 确定enzastaurin和enzastaurin代谢产物的浓度，以便纳入后续的群体PK分析中。

[Translation]

Primary Objectives: To evaluate the superiority of enzastaurin in combination with concurrent chemoradiotherapy plus adjuvant chemotherapy with temozolomide compared with placebo in terms of overall survival (OS) in patients with newly diagnosed glioblastoma who are Denovo Genetic Signature 1 (DGM1) positive. Secondary Objectives: 1. To compare progression-free survival (PFS) between treatment arms in patients who are DGM1 biomarker positive. 2. To compare objective response rate (ORR) between treatment arms in patients who are DGM1 biomarker positive. 3. To further evaluate the safety profile of enzastaurin added to concurrent chemoradiotherapy plus adjuvant chemotherapy with temozolomide. Exploratory Objectives: 1. To evaluate overall survival (OS) in patients who are DGM1 biomarker negative. 2. To determine if the presence of pigmenturia (orange/red urine) is associated with improved survival in patients taking enzastaurin. 3. To analyze the presence of enzastaurin and enzastaurin metabolites in urine (urine pharmacokinetics [PK]). 4. Evaluate whether the presence of other germline or tumor biomarkers is associated with improved efficacy in patients taking enzastaurin. 5. Determine the concentrations of enzastaurin and enzastaurin metabolites for inclusion in subsequent population PK analyses.

Start Date13 Jul 2021

Sponsor / Collaborator

Denovo Biopharma LLC

[+2]

100 Clinical Results associated with Enzastaurin Hydrochloride

100 Translational Medicine associated with Enzastaurin Hydrochloride

100 Patents (Medical) associated with Enzastaurin Hydrochloride

258

Literatures (Medical) associated with Enzastaurin Hydrochloride

01 Jun 2024·Gene

Identification of hub genes and potential therapeutic mechanisms related to HPV positive head and neck squamous carcinoma based on full transcriptomic detection and ceRNA network construction

Article

Author: Zhang, Xinran ; Li, Rui ; Pan, Boyu ; Zhang, Tingting ; Deng, Jiayin ; Wang, Kunpeng ; Li, Xia

Infection with human papillomavirus (HPV) is a major risk factor for head and neck squamous cell carcinoma (HNSCC). The objective of this study is to investigate the gene expression profiles and signaling pathways that are specific to HPV-positive HNSCC (HPV⁺ HNSCC). Moreover, a competing endogenous RNA (ceRNA) network analysis was utilized to identify the core gene of HPV⁺ HNSCC and potential targeted therapeutic drugs. Transcriptome sequencing analysis identified 3,253 coding RNAs and 3,903 non-coding RNAs (ncRNAs) that exhibited preferentially expressed in HPV⁺ HNSCC. Four key signaling pathways were selected through pathway enrichment analysis. By combining ceRNA network and protein-protein interaction (PPI) network topology analysis, RNA Polymerase II Associated Protein 2 (RPAP2), which also exhibited high expression in HPV⁺ HNSCC based on the TCGA database, was identified as the hub gene. Gene set enrichment analysis (GSEA) results revealed RPAP2's involvement in various signaling pathways, encompassing basal transcription factors, ubiquitin-mediated proteolysis, adherens junction, other glycan degradation, ATP-binding cassette (ABC) transporters, and oglycan biosynthesis. Five potential small molecule targeted drugs (enzastaurin, brequinar, talinolol, phenylbutazone, and afuresertib) were identified using the cMAP database, with enzastaurin showing the highest affinity for RPAP2. Cellular functional experiments confirmed the inhibitory effect of enzastaurin on cell viability of HPV⁺ HNSCC and RPAP2 expression levels. Additionally, enzastaurin treatment suppressed the expression levels of the top-ranked long non-coding RNA (lncRNA), circular RNA (circRNA), and microRNA (miRNA) in the ceRNA network. This study based on the ceRNA network provides valuable insights into the molecular mechanisms and potential therapeutic strategies for HPV⁺ HNSCC, and provide theoretical basis for the exploration of HPV⁺ HNSCC biomarkers and the development of targeted drugs.

15 Mar 2024·The Journal of clinical investigation

Just a spoonful of metformin helps the medicine go down

Article

Author: Tzaridis, Theophilos ; Wechsler-Reya, Robert J

Diffuse intrinsic pontine glioma (DIPG) is a devastating brain tumor with a need for novel therapies. So far, monotherapies have failed to prolong survival for these patients, and combinatorial strategies have often shown severe, dose-limiting toxicities. In this issue of the JCI, Duchatel, Jackson, and colleagues address this challenge by introducing a drug combination that mitigates side effects and overcomes resistance. After identifying the PI3K/mTOR pathway as a therapeutic vulnerability, they treated DIPG-bearing mice with paxalisib and saw responses but also observed hyperglycemia as a severe side effect. Combining paxalisib with metformin mitigated this toxicity, but also upregulated protein kinase C (PKC) signaling. To tackle this mechanism of resistance, the authors added the PKC inhibitor enzastaurin to their drug combination and showed that this triple therapy led to improved survival. This approach paves the way for improved outcomes for patients with DIPG and other brain tumors.

15 Mar 2024·The Journal of clinical investigation

PI3K/mTOR is a therapeutically targetable genetic dependency in diffuse intrinsic pontine glioma

Article

Author: Hulleman, Esther ; Manning, Elizabeth E ; de Bock, Charles E ; Vilain, Ricardo E ; Germon, Zacary P ; Dayas, Christopher V ; Findlay, Izac J ; Firestein, Ron ; Hua, Susan ; Jackson, Evangeline R ; Beitaki, Tyrone ; Aksu, Michael ; Colino-Sanguino, Yolanda ; Cairns, Murray J ; Parackal, Sarah G ; Kilburn, Lindsay B ; Jamaluddin, M Fairuz B ; Whittle, James R ; Ashley, David M ; Sun, Claire Xin ; Hocke, Emily A ; Murray, Heather C ; McEwen, Holly P ; Laternser, Sandra ; Kiltschewskij, Dylan ; Nixon, Brett ; Dun, Matthew D ; Daniel, Paul ; Koschmann, Carl ; Valvi, Santosh ; Duchatel, Ryan J ; Eisenstat, David D ; Jain, Vaibhav ; Mueller, Sabine ; Wheeler, Helen ; Nazarian, Javad ; Mannan, Abdul ; Gregory, Simon G ; Tsoli, Maria ; Raabe, Eric H ; Thomas, Bryce C ; Persson, Mika L ; Tinkle, Christopher L ; Phoenix, Timothy N ; Valdes-Mora, Fatima ; Douglas, Alicia M ; Skerrett-Byrne, David A ; Ziegler, David S ; Hansford, Jordan R ; Staudt, Dilana E ; Vitanza, Nicholas A ; Kearney, Padraic S ; Alvaro, Frank ; Cain, Jason E ; Verrills, Nicole M

Diffuse midline glioma (DMG), including tumors diagnosed in the brainstem (diffuse intrinsic pontine glioma; DIPG), are uniformly fatal brain tumors that lack effective treatment. Analysis of CRISPR/Cas9 loss-of-function gene deletion screens identified PIK3CA and MTOR as targetable molecular dependencies across patient derived models of DIPG, highlighting the therapeutic potential of the blood-brain barrier-penetrant PI3K/Akt/mTOR inhibitor, paxalisib. At the human-equivalent maximum tolerated dose, mice treated with paxalisib experienced systemic glucose feedback and increased insulin levels commensurate with patients using PI3K inhibitors. To exploit genetic dependence and overcome resistance while maintaining compliance and therapeutic benefit, we combined paxalisib with the antihyperglycemic drug metformin. Metformin restored glucose homeostasis and decreased phosphorylation of the insulin receptor in vivo, a common mechanism of PI3K-inhibitor resistance, extending survival of orthotopic models. DIPG models treated with paxalisib increased calcium-activated PKC signaling. The brain penetrant PKC inhibitor enzastaurin, in combination with paxalisib, synergistically extended the survival of multiple orthotopic patient-derived and immunocompetent syngeneic allograft models; benefits potentiated in combination with metformin and standard-of-care radiotherapy. Therapeutic adaptation was assessed using spatial transcriptomics and ATAC-Seq, identifying changes in myelination and tumor immune microenvironment crosstalk. Collectively, this study has identified what we believe to be a clinically relevant DIPG therapeutic combinational strategy.

News (Medical) associated with Enzastaurin Hydrochloride

21 Nov 2023

·www.prnewswire.com

KAZIA PROVIDES OVERVIEW OF PAXALISIB RELATED PRESENTATIONS FROM THE SOCIETY OF NEURO-ONCOLOGY 2023 ANNUAL MEETING

SYDNEY, Nov. 21, 2023 /PRNewswire/ -- Kazia Therapeutics Limited (NASDAQ: KZIA), an oncology-focused drug development company, is pleased to provide key highlights of the clinical and preclinical paxalisib related presentations given by key thought leaders at the Society of Neuro-Oncology 2023 Annual Meeting. "The 2023 SNO Annual Meeting was another successful event with the latest advances in clinical trials, diagnosis and treatment of pediatric and adult patients with CNS malignancies," stated Dr. John Friend, CEO Kazia. "We are highly encouraged with the preliminary overall survival data from the PNOC022 clinical study that we believe will provide an alternative to the current therapies considered as standard of care." Key paxalisib highlights from the meeting: Friday, November 17th Combining ONC201 and paxalisib for the treatment of diffuse midline glioma (DMG); the preclinical results underpinning the international Phase II clinical trial (NCT05009992). Presenter: Evangeline R. Jackson; University of Newcastle, NSW, Australia The mechanism of action of both paxalisib and ONC201 were reviewed as well as the synergistic effects of their combination in DMG preclinical models Specifically, the authors observed how ONC201 over activates the PI3K-AKT pathway, which is the target pathway for paxalisib Consistent and statistically significant improvements were observed with the combination of paxalisb and ONC201 in DMG preclinical mouse models Two patient case studies were discussed; each receiving the combination of paxalisib and ONC201 through compassionate access 16-year old female with advanced and relapsed diffuse intrinsic pontine glioma (DIPG) who demonstrated significant neurological improvements as well as rapid tumour regression after receiving the combination Six-year old female with DIPG who received the combination of paxalisib and ONC201 after upfront radiation therapy. Tumor regression has been maintained for more than two years on paxalisib and ONC201 Exploiting the genetic dependency on PI3K/mTOR signaling for the treatment of H3-altered Diffuse Midline Glioma Presenter: Ryan Duchatel, PhD; University of Newcastle, NSW, Australia PI3K pathway activation is observed in >80% of all DMGs and was shown to be required for DMG cell growth The authors stated that the success of a monotherapy in DMG is highly unlikely; therefore they explored several combinations [of other therapies] with paxalisib with the aim of optimizing tolerability and efficacy of such combinations in preclinical mouse studies Adding metformin to paxalisib was observed to improve hyperglycemia (elevated blood glucose) as well as extend the overall survival rate The combination of paxalisib and enzastaurin (PKC inhibitor) was observed to further extend the overall survival when combined to radiation treatment Authors concluded the triple combination of paxalisib, enzastaurin and metformin warranted further investigation in clinical trials Phase I study of paxalisib and radiotherapy for CNS disease harboring PI3K pathway mutations: pilot analysis of circulating tumor DNA for patient eligibility confirmation and post-treatment response Presenter: Brandon Imber, MD, Memorial Sloan Kettering Cancer Center, NYC, USA This is a multi-institutional, Phase I trial of concurrent paxalisib and radiation therapy in patients with brain metastases with documented PI3K pathway mutations Study has expanded after data from the initial stage identified the maximal tolerated dose (45mg once daily) along with observed signals of clinical activity (100% response rate) The authors observed that plasma circulating tumor DNA (ctDNA) was able to accurately confirm the tumor's genetic mutations at baseline and can potentially be used as a biomarker to assess patient treatment response The authors presented a representative case from the ongoing Phase I study: 70-year-old woman with metastatic breast cancer with tumor harboring PIK3CA mutation received radiation therapy in combination with paxalisib for brain metastases Her baseline plasma ctDNA test before starting treatment detected the same PIK3CA mutation as her tumor MRI scan three months after treatment demonstrated radiographic response. In addition, a 99% reduction in the amount of ctDNA with PIK3CA mutation compared to baseline was detected, indicating ctDNA can potentially be used as an accurate method to monitor response after radiation therapy in combination with paxalisib This is the first time in this patient population to demonstrate a link between MRI findings and a blood-based measure of tumor burden (ctDNA) Sunday, November 19 PNOC022: a combination therapy trial using an adaptive platform design for patients with diffuse midline gliomas (DMGs) at initial diagnosis, post-radiation therapy and at time of therapy Presenter: Sabine Mueller, MD, UCSF, San Francisco, USA 30 sites open to enrollment in North America, Europe and Australia Total enrollment to date: 137 patients Cohort 1 (newly diagnosed) = 37 patients Cohort 2 (post radiation therapy) = 69 patients (one patient was replaced due to physician preference) Cohort 3 (at the time of recurrence) = 31 patients Cohort 2 preliminary analyses (median follow-up time was approximately 9 months) Median Overall Survival rate was 16.5 months Median Progression Free Survival (PFS) was 9.9 months (central review is ongoing) Analysis of preliminary data from all cohorts is still ongoing and the protocol is subject to amendment to refine dosing with the aim of improving tolerability and efficacy at which time the enrollment of new patients will start Additional data includes ctDNA, microbiome and quality of life measures This announcement was authorized for release by Dr. John Friend, CEO. About Kazia Therapeutics Limited Kazia Therapeutics Limited (NASDAQ: KZIA) is an oncology-focused drug development company, based in Sydney, Australia. Our lead program is paxalisib, a brain-penetrant inhibitor of the PI3K / Akt / mTOR pathway, which is being developed to treat multiple forms of brain cancer. Licensed from Genentech in late 2016, paxalisib is or has been the subject of ten clinical trials in this disease. A completed Phase II study in glioblastoma reported promising signals of clinical activity in 2021, and a pivotal study, GBM AGILE, is ongoing, with final data expected in CY2023. Other clinical trials are ongoing in brain metastases, DMGs, and primary CNS lymphoma, with several of these having reported encouraging interim data. Paxalisib was granted Orphan Drug Designation for glioblastoma by the US Food and Drug Administration (US FDA) in February 2018, and Fast Track Designation for glioblastoma by the US FDA in August 2020. In addition, paxalisib was granted Rare Pediatric Disease Designation and Orphan Designation by the US FDA for DIPG in August 2020, and for atypical teratoid / rhabdoid tumors in June 2022 and July 2022, respectively. Kazia is also developing EVT801, a small-molecule inhibitor of VEGFR3, which was licensed from Evotec SE in April 2021. Preclinical data has shown EVT801 to be active against a broad range of tumor types and has provided evidence of synergy with immuno-oncology agents. A Phase I study in advanced solid tumors commenced recruitment in November 2021. For more information, please visit or follow us on Twitter @KaziaTx. Forward-Looking Statements This announcement may contain forward-looking statements, which can generally be identified as such by the use of words such as "may," "will," "estimate," "future," "forward," "anticipate," or other similar words. Any statement describing Kazia's future plans, strategies, intentions, expectations, objectives, goals or prospects, and other statements that are not historical facts, are also forward-looking statements, including, but not limited to, statements regarding: the timing for results and data related to Kazia's clinical and preclinical trials, and Kazia's strategy and plans with respect to its programs, including paxalisib and EVT801, as well as any potential future indications and timing for the release of interim or final data for such programs. Such statements are based on Kazia's current expectations and projections about future events and future trends affecting its business and are subject to certain risks and uncertainties that could cause actual results to differ materially from those anticipated in the forward-looking statements, including risks and uncertainties: associated with clinical and preclinical trials and product development, including the risk that preliminary or interim data may not reflect final results, related to regulatory approvals, and related to the impact of global economic conditions. These and other risks and uncertainties are described more fully in Kazia's Annual Report, filed on form 20-F with the United States Securities and Exchange Commission (SEC), and in subsequent filings with the SEC. Kazia undertakes no obligation to publicly update any forward-looking statement, whether as a result of new information, future events, or otherwise, except as required under applicable law. You should not place undue reliance on these forward-looking statements, which apply only as of the date of this announcement. SOURCE Kazia Therapeutics Limited

Clinical ResultPhase 1Fast TrackOrphan DrugPhase 2

01 May 2023

·www.prnewswire.com

Significant Positive Shift in the Glioma Market with 13% CAGR During the Study Period (2019-2032) Expected by Analysts at DelveInsight

The dynamics of the glioma market are anticipated to change in the coming years owing to the positive outcomes of the emerging pipeline candidates during the developmental stage by key players, such as Bayer, VBL Therapeutics, Candel Therapeutics, AstraZeneca, DNAtrix, DelMar Pharmaceuticals, Chimerix, KaryoPharma, VBI Vaccines, Kazia Therapeutics, and others LAS VEGAS, May 1, 2023 /PRNewswire/ -- DelveInsight's Glioma Market Insights report includes a comprehensive understanding of current treatment practices, glioma emerging drugs, market share of individual therapies, and current and forecasted market size from 2019 to 2032, segmented into 7MM [the United States, the EU-4 (Italy, Spain, France, and Germany), the United Kingdom, and Japan]. Key Takeaways from the Glioma Market Report As per DelveInsight analysis, the glioma market size in the 7MM was approximately USD 1 billion in 2022. According to the assessment done by DelveInsight, the estimated total incident glioma cases in the 7MM were approximately 47K in 2022. Leading glioma companies such as Bayer, Chimerix, Aivita Biomedical, Denovo Biopharma, Northwest Therapeutics, VBL Therapeutics, Laminar Pharmaceuticals, MedImmune, DNAtrix, Immunomic Therapeutics, Imvax, MimiVax, CNS Pharmaceuticals, Epitopoietic Research Corporation (ERC), Istari Oncology, SonALAsense, Kintara Therapeutics, Bristol Myers Squibb, Medicenna Therapeutics, BioMimetix, Eisai and Merck Sharp & Dohme, Kazia Therapeutics, Oblato, Genenta Science, Enterome, Inovio Pharmaceuticals, Karyopharm Therapeutics, VBI Vaccines, TME Pharma, Day One Biopharmaceuticals, Servier, Orbus Therapeutics, TVAX Biomedical, AnHeart Therapeutics, Beigene, SpringWorks Therapeutics, Forma Therapeutics, Hoffmann-La Roche, Incyte Corporation, Eli Lilly, and others are developing novel glioma drugs that can be available in the glioma market in the coming years. The promising glioma therapies in the pipeline include Regorafenib, ONC201, AV-GBM-1, Enzastaurin (DB-102), DCVax-L, Ofranergene Obadenovec (VB-111), LAM561 (2-OHOA), MEDI4736 (durvalumab), Tasadenoturev (DNX-2401), ITI-1000 (pp65 DC Vaccine), IGV-001, SurVaxM, Berubicin, GLIOVAC (Sitoiganap), Lerapolturev + Pembrolizumab, SONALA-001 + Exablate 2.0 Device, VAL-083 (dianhydrogalactitol), Pomalidomide, MDNA55, BMX-001, Lenvatinib ± Pembrolizumab, Paxalisib (GDC-0084), OKN-007, Temferon, EO2401, INO-5401+ INO-9012+ LIBTAYO (cemiplimab), Selinexor (KPT-330), Olutasidenib (FT-2102), VBI-1901, NOX-A12 (Olaptesed Pegol), Tovorafenib (DAY101), Vorasidenib (AG-881), Eflornithine, TVI-Brain-1, AB-218, BGB-290, Mirdametinib, FT-2102 (Olutasidenib), Vinblastine + Bevacizumab, Cobimetinib, PEMAZYRE (Pemigatinib), VERZENIO (abemaciclib) , and others. In December 2022, Chimerix announced the successful launch of the ONC201 Phase III ACTION study in patients with H3 K27M-mutant glioma. In June 2022, Day One Biopharmaceuticals announced positive initial data from its pivotal Phase II (FIREFLY-1) study with tovorafenib (DAY101) in relapsed pediatric low-grade glioma (pLGG). Discover which therapies are expected to grab the major glioma market share @ Glioma Market Report Glioma Overview Glioma is the most common kind of glial cell tumor in the central nervous system (CNS). Gliomas are infiltrative tumors that affect the brain tissue surrounding them. Glioblastoma is the most hazardous type of brain tumor, whereas pilocytic astrocytomas are the least dangerous. Previously, diffuse gliomas were classified into subgroups and grades depending on histopathologies, such as diffuse astrocytomas, oligodendrogliomas, or mixed gliomas/oligoastrocytomas. The specific etiology of glioma, like other primary brain tumors, remains unknown. However, certain variables may increase the risk of getting a brain tumor. Glioma symptoms vary depending on tumor type, size, location, and growth rate. Some common glioma symptoms include headache, nausea or vomiting, memory loss, urine incontinence, speech problems, and others. A medical history and a physical examination are used for glioma diagnosis. Glioma Epidemiology Segmentation DelveInsight estimates that there were approximately 47K incident cases of glioma in the 7MM in 2022. As per our analysis, the United States contributed to the largest incident population of glioma, acquiring ~40% of the 7MM in 2022. The glioma market report proffers epidemiological analysis for the study period 2019–2032 in the 7MM segmented into: Total glioma incident cases Glioma grade-specific cases Glioma age-specific cases Glioma type-specific cases Download the report to understand which factors are driving glioma epidemiology trends @ Glioma Epidemiological Insights Glioma Treatment Market Glioma treatment is based on the type of glioma, its size and location, and the patient's unique characteristics. Chemotherapy and radiation therapy will be administered after surgery, particularly in individuals when the tumor cannot be removed entirely because it has invaded critical parts of the brain or is inaccessible. The typical glioma treatment protocol comprises surgery, chemotherapy, and radiation. Chemotherapy may include carmustine (BCNU), lomustine (CCNU), or gleostine (generic), cisplatin, carboplatin, etoposide, and irinotecan in case of low-grade glioma whereas temozolomide (TEMODAR) is the standard chemotherapy used in case of high-grade glioma majorly, Gliadel wafer implants (biodegradable discs injected with BCNU) are usually given as adjunctive treatment after surgery, although usage of Gliadel wafers remains a point of controversy due to its questionable survival benefits. Avastin (Genentech) and Temodar/Temodal (Merck), among others, are approved medications for HGG. However, due to patent expiration, the generic version of Temodar and biosimilars of Avastin are available on the glioma market. As generics and biosimilars are more cost-effective for patients than new medicines, intense competition exists among them. Furthermore, due to a lack of knowledge concerning bevacizumab's overall survival benefit, it is not recommended in unselected patients with newly diagnosed GBM. Currently, only one medication for LGG is approved, Tafinlar (dabrafenib) plus Mekinist (trametinib). Moreover, the current therapeutic market lacks a viable method for curing glioblastoma; therefore, the survival rate of people diagnosed with glioma remains poor. Glioma is incurable, and treatment choices are limited. Furthermore, the tumor has a high recurrence rate and a poor patient prognosis. In addition, there is currently no approved therapy for the unmethylated MGMT patient pool. To know more about glioma treatment guidelines, visit @ Glioma Management Glioma Therapies and Key Companies Regorafenib: Bayer ONC201: Chimerix AV-GBM-1: Aivita Biomedical Enzastaurin (DB-102): Denovo Biopharma DCVax-L: Northwest Therapeutics Ofranergene Obadenovec (VB-111): VBL Therapeutics LAM561 (2-OHOA): Laminar Pharmaceuticals MEDI4736 (durvalumab): MedImmune Tasadenoturev (DNX-2401): DNAtrix ITI-1000 (pp65 DC Vaccine): Immunomic Therapeutics IGV-001: Imvax SurVaxM: MimiVax Berubicin: CNS Pharmaceuticals GLIOVAC (Sitoiganap): Epitopoietic Research Corporation (ERC) Lerapolturev + Pembrolizumab: Istari Oncology SONALA-001 + Exablate 2.0 Device: SonALAsense VAL-083 (dianhydrogalactitol): Kintara Therapeutics Pomalidomide: Bristol Myers Squibb MDNA55: Medicenna Therapeutics BMX-001: BioMimetix Lenvatinib ± Pembrolizumab: Eisai and Merck Sharp & Dohme Paxalisib (GDC-0084): Kazia Therapeutics OKN-007: Oblato Temferon: Genenta Science EO2401: Enterome INO-5401+ INO-9012+ LIBTAYO (cemiplimab): Inovio Pharmaceuticals Selinexor (KPT-330): Karyopharm Therapeutics VBI-1901: VBI Vaccines NOX-A12 (Olaptesed Pegol): TME Pharma Tovorafenib (DAY101): Day One Biopharmaceuticals Vorasidenib (AG-881): Servier Eflornithine: Orbus Therapeutics TVI-Brain-1: TVAX Biomedical AB-218: AnHeart Therapeutics BGB-290: Beigene Mirdametinib: SpringWorks Therapeutics FT-2102 (Olutasidenib): Forma Therapeutics Vinblastine + Bevacizumab: Hoffmann-La Roche Cobimetinib: Hoffmann-La Roche PEMAZYRE (Pemigatinib): Incyte Corporation VERZENIO (abemaciclib): Eli Lilly Learn more about the FDA-approved drugs for glioma @ Drugs for Glioma Treatment Glioma Market Dynamics Glioma market growth can be ascribed to various factors, including an aging population, evolving research, better diagnostic tests, developing surgical procedures, improved radiotherapy techniques, and novel systemic medicines. Commercially, there is a greater emphasis on high-grade glioma than low-grade glioma because patients with low-grade glioma often live longer than those with high-grade glioma. As a result, just a few therapies are in late-stage studies, while the majority are in early-stage trials. In the case of GBM, on the other hand, the pipeline is robust, with numerous potential therapies in late and mid-stage research that have yet to be marketed. The pipeline includes drugs with varied modes of action and administration routes. It is interesting to note that the emerging market of glioma includes budding gene therapy, i.e., ofranergene obadenovec (VB-111) by VBL Therapeutics, followed by four vaccine/immunotherapy candidates such as VBI-1901, AV-GBM-1 and ITI-1000 (pp65 DC Vaccine), tasadenoturev (DNX-2401) by VBI Vaccines, Aivita Biomedical, Immunomic Therapeutics, and DNAtrix, respectively, and these therapies are going to alter the glioma market dynamics in the upcoming years. The current glioma market has been categorized based on the dominant treatment pattern across the 7MM, which shows slight variances in the overall prescription pattern. The forecast model considers surgery, chemotherapy/radiation therapy, bevacizumab + radiotherapy/chemotherapy, and OPTUNE with temozolomide. The anticipated launch of new therapies and improved integration of early patient screening, medication in secondary care and other clinical settings, research on optimum implementation methods, and increased awareness may eventually facilitate the development of successful treatment alternatives. However, there are a few challenges to the timely identification and treatment of these patients, such as a lack of a reliable biomarker that can aid in diagnosis and patient classification and identifying recurrence and signaling medication response. Furthermore, the failure rate of high-phased drug trials is significant, making it impossible to predict trial success, exacerbating the need for medicines that could assist ease the patient segment with this severe kind of cancer. Scope of the Glioma Market Report Therapeutic Assessment: Glioma current marketed and emerging therapies Glioma Market Dynamics: Conjoint Analysis of Emerging Glioma Drugs Competitive Intelligence Analysis: SWOT analysis and Market entry strategies Unmet Needs, KOL's Views, Analyst's Views, Glioma Market Access and Reimbursement Discover more about glioma drugs in development @ Glioma Clinical Trials Table to Contents Related Reports Glioma Epidemiology Forecast Glioma Epidemiology Forecast – 2032 report delivers an in-depth understanding of the disease, historical and forecasted glioma epidemiology in the 7MM, i.e., the United States, EU5 (Germany, Spain, Italy, France, and the United Kingdom), and Japan. Glioma Pipeline Glioma Pipeline Insight – 2023 report provides comprehensive insights about the pipeline landscape, pipeline drug profiles, including clinical and non-clinical stage products, and the key glioma companies, including PTC Therapeutics, Ono Pharmaceuticals, Philogen, SpringWorks Therapeutics, Xennials Therapeutics, AnHeart Therapeutics, Istari Oncology, among others. High-Grade Glioma Pipeline High-Grade Glioma Pipeline Insight – 2023 report provides comprehensive insights about the pipeline landscape, pipeline drug profiles, including clinical and non-clinical stage products, and the key high-grade glioma companies, including PTC Therapeutics, Aadi, Lee's Pharmaceutical, among others. Malignant Glioma Pipeline Malignant Glioma Pipeline Insight – 2023 report provides comprehensive insights about the pipeline landscape, pipeline drug profiles, including clinical and non-clinical stage products, and the key malignant glioma companies, including Bexion Pharmaceuticals, Inc., Lee's Pharmaceutical Limited, Merck & Co, Oblato, Inc., OncoSynergy, Inc, among others. Recurrent Malignant Glioma Pipeline Recurrent Malignant Glioma Pipeline Insight – 2023 report provides comprehensive insights about the pipeline landscape, pipeline drug profiles, including clinical and non-clinical stage products, and the key recurrent malignant glioma companies, including Bexion Pharmaceuticals, Inc., Merck, Oblato, OncoSynergy, Inc, among others. Glioblastoma Pipeline Glioblastoma Pipeline Insight – 2023 report provides comprehensive insights about the pipeline landscape, pipeline drug profiles, including clinical and non-clinical stage products, and the key glioblastoma companies, including AstraZeneca, BioNTech, Merck, Pfizer, Roche, among others. Other Trending Reports Tay-sachs Disease Or Gm2 Gangliosidosis Market | Onycholysis Market | Diagnostic Imaging Equipment Market | Chemotherapy-induced Peripheral Neuropathy Market | Global Electrophysiology Devices Market | Anaphylaxis Market | Atherectomy Devices Market | Helicobacter Pylori Infections Market | Ophthalmic Imaging Equipment Market | Androgenetic Alopecia Market | Allergic Rhinitis Market | Chronic Inflammatory Demyelinating Polyneuropathy Market | Chronic Inflammatory Demyelinating Polyneuropathy Market | Colorectal Cancer Crc Market | Opioid Induced Constipation Market | Vertigo Market | Bone Anchored Hearing Systems Market | Wound Closure Devices Market | Hip Replacement Devices Market | Hemodynamic Monitoring Systems Market | Egfr Non-small Cell Lung Cancer Market | Helicobacter Pylori Infection Market | Hyperkalemia Market | Polycythemia Market Neurostimulation Devices Market | Carpal Tunnel Syndrome Market | Ventilator Market | Cerebral Aneurysm Market | Alpha Antitrypsin Market | Binge Eating Disorder Market | Bunion Market | Concussions Market Size | Exocrine Pancreatic Insufficiency Market | Healthcare Due Diligence Services | Minimal Residual Disease Market | Hypertrophic Scar Market | Lung Fibrosis Market | Anterior Uveitis Market | 22q11.2 deletion syndrome Market | X-Linked Retinitis Pigmentosa (XLRP) Market | Acute Radiation Syndrome Market | Alpha-1 Protease Inhibitor Deficiency Market | Androgenetic Alopecia Market | Hyperlipidemia Market | Cardiotoxicity Market | Hypertrophic Cardiomyopathy Market | Fatty Acid Oxidation Disorders (FAODs) Market | Androgen Insensitivity Syndrome Market | Emphysema Market | Canaloplasty Market | Dravet Syndrome Market | Celiac Disease Market | Chlamydia Infections Market | Syphilis Market | Renal Tubular Acidosis Market | Palmoplantar Pustulosis (PPP) Market | Aplastic Anemia Market | Bacterial Pneumonia Market | B cell Chronic Lymphocytic Leukemia Market | B cell Lymphomas Market | Behcets Disease Market Neoantigen-based Personalized Cancer therapeutic Vaccines Competitive Landscape and Market Forecast—by 2035 | Glioblastoma Market Related Healthcare Services Healthcare Consulting Healthcare Competitive Intelligence Services Healthcare Asset Prioritization Services About DelveInsight DelveInsight is a leading Business Consultant and Market Research firm focused exclusively on life sciences. It supports pharma companies by providing comprehensive end-to-end solutions to improve their performance. Get hassle-free access to all the healthcare and pharma market research reports through our subscription-based platform PharmDelve . Connect with us on LinkedIn |Facebook|Twitter Contact Us Shruti Thakur [email protected] +1(919)321-6187 Logo: SOURCE DelveInsight Business Research, LLP

Phase 3Phase 2VaccineImmunotherapy

21 Feb 2023

·www.biospace.com

Aytu BioPharma Reports Second Quarter of Fiscal Year 2023

Second Consecutive Quarter of Positive Adjusted EBITDA Quarterly Net Revenue of $26.3 Million Driven by 23% Growth in Rx Segment Company to Host Conference Call Today at 5:00pm ET ENGLEWOOD, CO / ACCESSWIRE / February 21, 2023 / Aytu BioPharma, Inc. (the Company or "Aytu") (NASDAQ:AYTU), a commercial stage pharmaceutical and consumer health company providing pediatric-focused prescription drugs and cost-effective consumer health solutions, today announced financial and operational results for the quarter ended December 31, 2022. Q2 2023 Commercial Highlights (3 months ending December 31, 2022) Total net revenue was $26.3 million, an increase of 14% over the $23.1 million in net revenue in the year ago quarter. Net revenue from the Company's Rx segment was $18.0 million during Q2 2023 compared to $14.6 million in the year ago quarter, growth of 23%. ADHD products (Adzenys XR-ODT® and Cotempla XR-ODT®) net revenue increased by 2% to $11.1 million from $10.9 million in the year ago quarter. Pediatric products (Poly-Vi-Flor®, Tri-Vi-Flor®, and Karbinal® ER) net revenue increased 95% to $6.3 million, from $3.2 million in the year ago quarter. Consumer Health revenue during Q2 2023 was $8.3 million, a decrease of 3% over the year ago quarter due largely to a shift away from the Consumer Health segment's direct mail channel to focus on the higher contribution margin OTC medicines e-commerce channel. The segment's core OTC medicines e-commerce portfolio revenue grew 70% over the year ago quarter. Gross margins increased to 66% in Q2 2023 compared to 53% in the year ago quarter. Total Adjusted EBITDA1 was a positive $0.7 million in Q2 2023 compared to $(7.6) million in the year ago quarter. Expenditures attributable to the suspended Pipeline R&D were approximately $1.3 million in Q2 2023. On October 13, 2022, the Company announced a shift of its strategy aimed at accelerating the growth of its commercial business and achieving corporate profitability. As a result, the Company announced the indefinite suspension of its clinical development programs, including AR101/enzastaurin for the treatment of Vascular Ehlers-Danlos Syndrome (VEDS). The suspension is expected to save the Company over $20.0 million in projected future study costs. ________________________ [1] Aytu uses the term EBITDA, which is a term not defined under United States Generally Accepted Accounting Principles. The Company uses this term because it is a widely accepted financial indicator utilized to analyze and compare companies on the basis of operating performance. The Company believes that presenting EBITDA by segments allows investors to evaluate the various performance of these segments. The Company's method of computation of adjusted EBITDA may or may not be comparable to other similarly titled measures used by other companies.We believe that net loss is the performance measure calculated and presented in accordance with U.S. GAAP that is most directly comparable to EBITDA. Management Discussion "I am extremely pleased with the recent momentum the business has gained as we report our second consecutive quarter of positive Adjusted EBITDA and strong top-line performance in our Rx segment," commented Josh Disbrow, Chief Executive Officer of Aytu BioPharma. "We made strategic decisions in October 2022 to accelerate the growth of our commercial businesses and indefinitely suspend our clinical development programs, both of which have put us on a faster path to profitability. Within our Rx segment, Pediatric products net revenue increased 95% driven by the leverage we're achieving through our proprietary Aytu RxConnect platform, while ADHD scripts for the quarter rose 8.1% sequentially, highlighting the growing demand for our products. This period marks the third consecutive quarter that the Rx segment achieved positive Adjusted EBITDA. This achievement demonstrates the strength and growth of our prescription business." "Our Consumer Health segment continues to execute on our objectives to improve segment profitability, with a focus on more efficient, higher contribution margin online sales channels, resulting in a significant 30% improvement in the segment's negative EBITDA over the same quarter last year. Revenues from the Consumer Health segment will likely be impacted as we phase out the direct mail channel and focus on OTC medicines and their e-commerce sales. This shift is expected to drive improvement to EBITDA within the Consumer Health segment.As we prepare to launch our C'rcle Health branding initiative later this year, we believe we are well positioned to build upon our recent gains and propel this segment to profitability." "The significant progress we have made over the past two quarters, along with the initiatives we've put in place for further improvements and cost reductions during the remainder of fiscal 2023, have put us in a stronger financial position to drive long-term shareholder value," Disbrow concluded. Segment Reporting Three Months Ended December 31, 2022 2021 (In thousands) Consolidated revenue: Rx Segment $ 18,029 $ 14,643 Consumer Health Segment 8,250 8,482 Consolidated revenue $ 26,279 $ 23,125 Rx Segment ADHD $ 11,120 $ 10,850 Pediatric 6,328 3,248 Other* 581 545 $ 18,029 $ 14,643 *Other includes discontinued or deprioritized products. Q2 2023 Financial Results Net revenue for the second quarter of fiscal 2023 was $26.3 million, compared to $23.1 million for the second quarter of fiscal 2022, a 14% increase year-over-year. Net revenue from the Rx segment in the second quarter of fiscal 2023 was $18.0 million, an increase of 23% over the same quarter last year. ADHD brands Adzenys XR-ODT and Cotempla XR-ODT experienced 2% growth in net prescription revenue to $11.1 million in the second quarter of fiscal 2023. ADHD Portfolio net revenue grew despite being affected by calendar year-end weather-related shipping delays that pushed ADHD Portfolio revenue into Q3. The Pediatric Portfolio comprised of Poly-Vi-Flor, Tri-Vi-Flor, and Karbinal ER experienced 95% growth in net revenue to $6.3 million in the second quarter of fiscal 2023. Net revenue from the Consumer Health segment was $8.3 million in the second quarter of fiscal 2023, a decrease of 3% over the same quarter last year. Net revenue was impacted by the Company's strategic decision in fiscal 2022 to pivot its efforts to the more efficient, higher margin ecommerce channel, with a primary focus on improving its visibility on, and sales of, value OTC medicines through Amazon and the Company's websites. The segment's core Amazon OTC medicines business grew 70% over the same period last year. Gross profit increased to $17.3 million, or 66% of net revenue, in the second quarter of fiscal 2023, compared to $12.3 million, or 53% of net revenue, in the same quarter last year. The improvement was primarily driven by sales gains in the higher margin Pediatric Portfolio and continuing cost reduction efforts. Operating expenses, excluding impairment expense and amortization of intangible assets, were $20.3 million in the second quarter of fiscal 2023 compared to $22.1 million in the same quarter last year, a decrease of 8%. Research and development expenses were $1.7 million in the second quarter of fiscal 2023 compared to $4.5 million in the same quarter last year. Of this $1.7 million, $1.3 million were expenses associated with the recently suspended AR101/enzastaurin pipeline program. Net loss during the second quarter of fiscal 2023 was impacted by an impairment of $2.6 million relating to the pipeline development of the NT-502 development program. The Company expects to terminate this program and the associated licensing agreement. There were no impairments during the second quarter of fiscal 2022. Net loss for the second quarter of fiscal 2023 was $(6.7) million, or $(2.15) per share, compared to $(11.5) million, or $(8.74) per share for the same quarter last year. Adjusted EBITDA (see Table A-1) was $0.7 million in the second quarter of fiscal 2023, compared to $(7.6) million in the year ago quarter. Balance Sheet and Operational Improvements Cash and cash equivalents on December 31, 2022 were $19.5 million compared to $23.8 million on September 30, 2022. As part of the Company's indefinite suspension of its clinical development programs, the Company expects to save over $20.0 million in projected future study costs. The manufacturing transfer to a global contract manufacturer of the ADHD products remains on track to be completed in calendar 2023, and this transition is expected to further improve gross margins of Adzenys XR-ODT and Cotempla XR-ODT. During the quarter, the Company announced an agreement with the Avenue Venture Opportunities Fund, L.P. ("Avenue Venture Debt Fund" or "Avenue") to extend the interest-only period of the Company's existing senior secured loan facility held with Avenue. This amendment to the original secured loan agreement extends the interest-only period to January of 2024. The maturity date of the Avenue secured loan is January 2025 and remains subject to additional interest-only period extensions upon the achievement of certain milestones by the Company. The extension of the interest-only period will conserve cash and save the Company over $3 million in calendar 2023 principal payments by deferring those payments into 2024 and 2025. In exchange for this extension, the Company and Avenue agreed to reset the exercise price of the warrants issued in conjunction with the original loan agreement to $8.60 ($0.43 before the reverse split), corresponding to the warrant exercise price associated with the Company's August 2022 equity financing. The company implemented a 1-for-20 reverse stock split, effective January 6, 2023. This action enabled the Company to regain full compliance with Nasdaq's listing requirements effective January 23, 2023. Warrant Transactions The Company evaluated the accounting for previously granted warrants included in its debt and equity transactions. The Company restated Form 10-Q for the quarter ending September 30, 2022 in order to modify the accounting for certain warrants to liabilities from equity treatment. The changes in the restated Form 10-Q resulted in a reclassification of the value of these warrants from additional paid in capital to liabilities. Going forward, the Company will value these warrants on a quarterly basis, which could result in additional income or expense and a corresponding decrease or increase in derivative warrant liabilities. These adjustments have no impact on cash, working capital, cash flows from operations or Adjusted EBITDA. Conference Call Details Aytu will host a conference call today, Tuesday, February 21st, 2023, at 5:00 PM Eastern Time to discuss financial results for the second fiscal quarter of 2023 for the quarter ended December 31, 2022. The conference call will be available via telephone by dialing toll free 888-506-0062 for U.S. callers or for international callers 973-528-0011 and using entry code 371594. A webcast of the call may be accessed at . A webcast replay will be available on the Investors News/Events section of the Company's website through. A telephone replay of the call will be available approximately one hour following the call, through February 28, 2023, and can be accessed by dialing 877-481-4010 for U.S. callers or 919-882-2331 for international callers and entering replay access code 47499. About Aytu BioPharma, Inc. Aytu BioPharma is a pharmaceutical company commercializing a portfolio of commercial prescription therapeutics and consumer health products. The Company's prescription products include Adzenys XR-ODT® (amphetamine) extended-release orally disintegrating tablets (see Full Prescribing Information, including Boxed WARNING) and Cotempla XR-ODT® (methylphenidate) extended-release orally disintegrating tablets (see Full Prescribing Information, including Boxed WARNING) for the treatment of attention deficit hyperactivity disorder (ADHD), as well as Karbinal® ER (carbinoxamine maleate), an extended-release antihistamine suspension indicated to treat numerous allergic conditions, and Poly-Vi-Flor® and Tri-Vi-Flor®, two complementary fluoride-based prescription vitamin product lines available in various formulations for infants and children with fluoride deficiency. Aytu's consumer health segment markets a range of over-the-counter medicines, personal care products, and dietary supplements addressing a range of common conditions including diabetes, allergy, hair regrowth, and gastrointestinal conditions. To learn more, please visit aytubio.com. Forward-Looking Statement This press release includes forward-looking statements within the meaning of Section 27A of the Securities Act of 1933, as amended, and Section 21E of the Securities Exchange Act of 1934, or the Exchange Act. All statements other than statements of historical facts contained in this press release, are forward-looking statements. Forward-looking statements are generally written in the future tense and/or are preceded by words such as ''may,'' ''will,'' ''should,'' ''forecast,'' ''could,'' ''expect,'' ''suggest,'' ''believe,'' ''estimate,'' ''continue,'' ''anticipate,'' ''intend,'' ''plan,'' or similar words, or the negatives of such terms or other variations on such terms or comparable terminology. All statements other than statements of historical facts contained in this presentation, are forward-looking statements. These statements are just predictions and are subject to risks and uncertainties that could cause the actual events or results to differ materially. These risks and uncertainties include, among others, risks associated with: the company's plans relating to the Company's ability to efficiently wind down clinical development and reduce spend associated with AR101 and Healight™, the Company's ability to complete the manufacturing transfer of Adzenys XR-ODT® and Cotempla XR-ODT®, the company's overall financial and operational performance, potential adverse changes to our financial position or our business, the results of operations, strategy and plans, changes in capital markets and the ability of the company to finance operations in the manner expected, risks relating to gaining market acceptance of our products, risks related to the ongoing COVID-19 pandemic and its impact on our operations, our ability to effectively integrate operations and manage integration costs following our acquisitions, our partners performing their required activities, our anticipated future cash position, regulatory and compliance challenges and future events under current and potential future collaboration. We also refer you to (i) the risks described in ''Risk Factors'' in Part I, Item 1A of Aytu's most recent Annual Report on Form 10-K and in the other reports and documents it files with the Securities and Exchange Commission. Contacts for Investors: Mark Oki, Chief Financial Officer Aytu BioPharma, Inc. moki@aytubio.com Robert Blum or Roger Weiss Lytham Partners AYTU@lythampartners.com AYTU BIOPHARMA, INC. Condensed Consolidated Statements of Operations (In thousands, except share and per-share) (Three Month Period Unaudited) Three Months Ended December 31, 2022 2021 Product revenue, net $ 26,279 $ 23,125 Cost of sales 8,986 10,826 Gross profit 17,293 12,299 Operating expenses Research and development 1,710 4,475 Selling and marketing 10,560 9,660 General and administrative 8,018 7,953 Impairment expense 2,600 - Amortization of intangible assets 1,198 1,505 Total operating expenses 24,086 23,593 Loss from operations (6,793 ) (11,294 ) Other expense Other expense, net (1,303 ) (257 ) Loss on derivative warrant liabilities 1,403 - Total other expense 100 (257 ) Loss before income tax (6,693 ) (11,551 ) Income tax benefit - (3 ) Net loss $ (6,693 ) $ (11,548 ) Weighted average number of common shares outstanding 3,110,304 1,320,623 Basic and diluted net loss per common share $ (2.15 ) $ (8.74 ) AYTU BIOPHARMA, INC. Condensed Consolidated Balance Sheets (In thousands, except share and per-share) (unaudited) December 31, June 30, 2022 2022 Assets Current assets Cash and cash equivalents $ 19,501 $ 19,360 Accounts receivable, net 25,547 21,712 Inventory, net 12,950 10,849 Prepaid expenses 11,989 7,375 Other current assets 624 633 Total current assets 70,611 59,929 Property and equipment, net 2,344 3,025 Operating lease right-of-use asset 2,675 3,271 Intangible assets, net 64,985 70,632 Other non-current assets 821 766 Total non-current assets 70,825 77,694 Total assets $ 141,436 $ 137,623 Liabilities Current liabilities Accounts payable and other $ 10,580 $ 10,987 Accrued liabilities 41,218 44,187 Short-term line of credit 7,429 3,813 Current portion of debt 90 96 Other current liabilities 7,833 5,359 Total current liabilities 67,150 64,442 Debt, net of current portion 14,533 14,279 Derivative warrant liabilities 4,155 1,796 Other non-current liabilities 9,781 12,798 Total liabilities 95,619 93,315 Commitments and contingencies Stockholders' equity Preferred Stock, par value $.0001; 50,000,000 shares authorized; no shares issued or outstanding as of December 31, 2022 and June 30, 2022 - - Common Stock, par value $.0001; 200,000,000 shares authorized; shares issued and outstanding 3,383,145 and 1,500,523, respectively, as of December 31, 2022 and June 30, 2022 - - Additional paid-in capital 340,289 331,386 Accumulated deficit (294,472 ) (287,078 ) Total stockholders' equity 45,817 44,308 Total liabilities and stockholders' equity $ 141,436 $ 137,623 Table A-1 - Segment Adjusted EBITDA (Quarterly) (in thousands) Rx Consumer Health Pipeline R&D Three Months Ended December 31, 2022 Rx Consumer Health Pipeline R&D Three Months Ended December 31, 2021 Reconciliation of net loss to Adjusted EBITDA: Net loss $ (3,996 ) $ (1,413 ) $ (1,284 ) $ (6,693 ) $ (5,387 ) $ (1,957 ) $ (4,204 ) $ (11,548 ) Addback: Depreciation and amortization 1,572 281 - 1,853 2,079 382 - 2,461 Impairment expense 2,600 - - 2,600 - - - - Stock based compensation 2,974 80 13 3,067 1,148 13 68 1,229 Other expense, net 1,321 (18 ) - 1,303 230 27 - 257 Gain on derivative warrant liabilities (1,403 ) - - (1,403 ) - - - - Income tax benefit - - - - (3 ) - - (3 ) Adjusted EBITDA $ 3,068 $ (1,070 ) $ (1,271 ) $ 727 $ (1,933 ) $ (1,535 ) $ (4,136 ) $ (7,604 ) SOURCE: Aytu BioPharma, Inc. View source version on accesswire.com:

Financial Statement

100 Deals associated with Enzastaurin Hydrochloride

External Link

KEGG	Wiki	ATC	Drug Bank
D04014	Enzastaurin Hydrochloride	-	DB06486

R&D Status

10 top R&D records.

to view more data

Indication	Highest Phase	Country/Location	Organization	Date
Ehlers-Danlos Syndrome	Phase 3	US	Aytu Biopharma, Inc.	01 Jan 2023
Diffuse Large B-Cell Lymphoma	Phase 3	US	Denovo Biopharma Co., Ltd.	28 Mar 2018
Diffuse Large B-Cell Lymphoma	Phase 3	CN	Denovo Biopharma Co., Ltd.	28 Mar 2018
Non-Hodgkin Lymphoma	Phase 3	US	Eli Lilly & Co.	01 Jun 2006
Non-Hodgkin Lymphoma	Phase 3	CN	Eli Lilly & Co.	01 Jun 2006
Non-Hodgkin Lymphoma	Phase 3	JP	Eli Lilly & Co.	01 Jun 2006
Non-Hodgkin Lymphoma	Phase 3	AU	Eli Lilly & Co.	01 Jun 2006
Non-Hodgkin Lymphoma	Phase 3	BE	Eli Lilly & Co.	01 Jun 2006
Non-Hodgkin Lymphoma	Phase 3	BR	Eli Lilly & Co.	01 Jun 2006
Non-Hodgkin Lymphoma	Phase 3	CA	Eli Lilly & Co.	01 Jun 2006

Clinical Result

Indication

Phase

Evaluation

View All Results

Study	Phase	Population	Analyzed Enrollment	Group	Results	Evaluation	Publication Date


NCT00452413 (CTgov)	Phase 1/2	Advanced Malignant Solid Neoplasm \| Non-Small Cell Lung Cancer	65	Erlotinib+Enzastaurin (Phase 1, Dose 1 and 2 (Enzastaurin and Erlotinib))	tdsbtuaitn(avibptpzhh) = grshujynxd hmtpwtgctl (ogxnuqquoz, btduvoejhg - mfciukvaox) View more	-	13 May 2021
				Erlotinib+Enzastaurin (Phase 2 (Enzastaurin 500 mg, Erlotinib 150 mg))	ykylxoimsx(ddumqblhkj) = jwbztxgxir jgbubamltt (ciuztrxivf, bpjfcrzdzu - gbevawokel) View more
NCT00308750 (CTgov)	Phase 2	Non-Small Cell Lung Cancer	218	carboplatin+enzastaurin+pemetrexed (Enzastaurin/Pemetrexed/Carboplatin)	begbqhtcct(avdjtfjczg) = yhhxrwnrya gqgdnwjmaf (fppszcqwjf, nzdzshumsy - xxvdplkohy) View more	-	13 May 2021
				carboplatin+pemetrexed (Pemetrexed/Carboplatin)	begbqhtcct(avdjtfjczg) = tyytenjygl gqgdnwjmaf (fppszcqwjf, yfcvamxfft - hqqwrupfpl) View more
NCT00533429 (H6Q-MC-S034, CTgov)	Phase 2	Non-Small Cell Lung Cancer	40	Carboplatin+Enzastaurin+Bevacizumab+Pemetrexed (Pemetrexed + Carboplatin + Bevacizumab + Enzastaurin)	vbzossezml(jjkwjfynzv) = ogujaxldgh qtyprdheyg (gaqafxiaue, wskyxefhfs - negwqwrywx) View more	-	13 May 2021
				Placebo+Carboplatin+Bevacizumab+Pemetrexed (Pemetrexed + Carboplatin + Bevacizumab + Placebo)	vbzossezml(jjkwjfynzv) = shbniehipq qtyprdheyg (gaqafxiaue, uireagydcf - xawerhmgtg) View more
NCT00420381 (CTgov)	Phase 2	Ovarian Cancer \| Recurrent Primary Peritoneal Carcinoma \| Carcinoma	28	Enzastaurin	mzpqagdzpr(zmvptihrtv) = deryamfmyj wvuzqzlygq (dghetimgfz, puhgewbsnl - ccuuhbebdr) View more	-	19 Dec 2020
NCT00428714 (CTgov)	Phase 2	Prostatic Cancer	73	enzastaurin (Enzastaurin-Cohort 1)	zsusmjurtt(tiyqxpwngk) = ipdmpbreec jsohqehhir (dlsgjhaclu, byuhakekdw - pqxdwriluh) View more	-	25 Nov 2020
				enzastaurin (Enzastaurin-Cohort 2)	fidinttanz(iioloteshw) = zfngnobqfs vegbwmlnqw (wzqiavbdyf, zyaypvmmcb - ateclccfry) View more
NCT00466440 (CTgov)	Phase 2	Metastatic castration-resistant prostate cancer	108	Prednisone+Enzastaurin+Docetaxel (Part 2: Docetaxel + Prednisone + Enzastaurin)	mxokxxojpq(fyohapltmk) = ulnciwyqpg jjpajrsphw (zrxknwidqt, fhyrvzqigi - nrobyqbwfu) View more	-	06 Nov 2020
				Placebo+Prednisone+Docetaxel (Part 2: Docetaxel + Prednisone + Placebo)	mxokxxojpq(fyohapltmk) = tuumttinbj jjpajrsphw (zrxknwidqt, bbheeubtex - qvdjcuooaa) View more
NCT00415363 (CTgov)	Phase 2	Small Cell Lung Cancer \| Non-Small Cell Lung Cancer \| Lung Cancer with Brain Metastasis	109	Enzastaurin (Enzastaurin)	cvwkuailyl(sbapwlhhal) = gaxhwsqdcn apneajaydg (pcqzwibebx, ximoeacxqs - kfyuoebhpr) View more	-	05 Nov 2020
				Placebo (Placebo)	cvwkuailyl(sbapwlhhal) = dmiwlidrym apneajaydg (pcqzwibebx, mklzzmdhje - hmifdqysng) View more
NCT00538681 (CTgov)	Phase 2	Metastatic Lung Cancer	35	enzastaurin+cisplatin+pemetrexed (Part 1- Cohort 1)	rfkfgaidna(ptgkvskweu) = rratppwtyo jbdgpcltar (rubuaellag, ooguhumnkr - fptklslrxv) View more	-	05 Nov 2020
				enzastaurin+cisplatin+pemetrexed (Part 1- Cohort 2)	rfkfgaidna(ptgkvskweu) = nfgzkkitrz jbdgpcltar (rubuaellag, rzbgublgqi - ektzuwwmsp) View more
NCT00744991 (CTgov)	Phase 2	Cutaneous T-Cell Lymphoma	25	Enzastaurin	qkkgufqxca(odditgbauc) = jntcpdahdc dtfpocpcil (mzevhqugzy, gpvwcjrszp - ssysayytmf) View more	-	19 Oct 2020
NCT00391118 (CTgov)	Phase 2	Ovarian Cancer \| Peritoneal Neoplasms \| Fallopian Tube Carcinoma	153	Carboplatin+Enzastaurin+Paclitaxel (Part 2 - Regimen A)	njcdvnhdqj(lukobxzmlc) = hqeixwdbmd kdflkotrns (qjdggrftfi, otfkcmhfrz - didrrgyppy) View more	-	19 Oct 2020
				Placebo+Carboplatin+Paclitaxel (Part 2 - Regimen B)	njcdvnhdqj(lukobxzmlc) = sfwpxuowbm kdflkotrns (qjdggrftfi, efqxxbpmnh - vmuigbdazx) View more

Translational Medicine

Boost your research with our translational medicine data.

view full example data

Deal

Boost your decision using our deal data.

view full example data

Core Patent

Boost your research with our Core Patent data.

view full example data

Clinical Trial

Identify the latest clinical trials across global registries.

view full example data

Approval

Accelerate your research with the latest regulatory approval information.

view full example data

Regulation

Understand key drug designations in just a few clicks with Synapse.

view full example data

Chat with Hiro

Get started for free today!

Accelerate Strategic R&D decision making with Synapse, PatSnap’s AI-powered Connected Innovation Intelligence Platform Built for Life Sciences Professionals.

Start your data trial now!

Synapse data is also accessible to external entities via APIs or data packages. Empower better decisions with the latest in pharmaceutical intelligence.

Bio

Bio Sequences Search & Analysis

Chemical

Chemical Structures Search & Analysis