On January 05, 2023 Tavanta Therapeutics, a clinical-stage specialty pharmaceutical company developing a diverse pipeline of specialty drugs that bring clinically meaningful benefits to patients with serious or debilitating diseases, reported positive top-line results from its pivotal, global Phase 3 clinical trial, evaluating the safety and efficacy of TAVT-45 (abiraterone acetate) Granules for Oral Suspension ("TAVT-45"), an investigational enhanced formulation of abiraterone acetate for the treatment of metastatic prostate cancer (Press release, Tavanta Therapeutics, JAN 5, 2023, View Source [SID1234625932]). The trial met its primary objective of establishing therapeutic equivalence of TAVT-45 to Zytiga in patients with metastatic castrate-resistant prostate cancer (mCRPC) and metastatic high-risk castrate-sensitive prostate cancer (mCSPC), in addition to demonstrating a comparable safety profile.

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The primary endpoint comparing serum testosterone levels at Days 9 and 10 was met, demonstrating therapeutic equivalence between TAVT-45 and Zytiga. The key secondary endpoint (a decrease of ≥ 50% in prostate-specific antigen [PSA] levels from baseline at any time over the 84-day treatment period) showed no statistical difference between treatment arms. The safety profile of TAVT-45 in the trial was in line with that of Zytiga.

"The positive results from the TAVT45C02 trial demonstrate that TAVT-45 may provide an easy-to-swallow alternative to Zytiga, benefitting many patients with dysphagia or difficulty swallowing large tablets," said Andreas Maetzel, M.D. Ph.D., chief medical officer of Tavanta Therapeutics. "Approximately 20 to 30 percent of cancer patients, including many patients with prostate cancer, have difficulty swallowing pills and capsules.i,ii We believe these patients may benefit from an alternate formulation like TAVT-45 that would allow them to take their much-needed medications in an easier-to-take formulation."

The Phase 3 registrational trial (Study TAVT45C02; NCT04887506) is a global, randomized, multi-center, open-label trial designed to evaluate the pharmacodynamic effect and safety profile of TAVT-45 compared to Zytiga tablets, in combination with prednisone, in patients with mCRPC and high-risk mCSPC. In addition to establishing therapeutic equivalence between TAVT-45 and Zytiga tablets, the study aims to characterize the multiple-dose pharmacokinetic profile of TAVT-45.

"It is encouraging to see a familiar efficacy and safety profile for TAVT-45, which is consistent with data established for abiraterone acetate as a standard of care in the treatment of metastatic prostate cancer," said Kenneth M. Kernen, M.D., study investigator and partner in the Michigan Institute of Urology. "The positive results from this clinical study further support and validate the use of TAVT-45 as a novel, oral, easy-to-drink formulation of abiraterone acetate. As a physician, this would be a welcome potential treatment alternative that may also help patients adhere to their medication regimens and may ultimately improve clinical outcomes."

"We would like to thank the clinical study site investigators and the patients who participated in this pivotal trial," said Lynne Powell, chief executive officer of Tavanta Therapeutics. "Tavanta intends to submit our New Drug Application (NDA) to the U.S. Food and Drug Administration (FDA), while also evaluating strategic options for the commercialization of TAVT-45."

Tavanta intends to present detailed results from this Phase 3 registrational study, TAVT45C02, at an upcoming medical meeting, as well as submit for publication.

About TAVT-45 Granules
TAVT-45 (abiraterone acetate) Granules for Oral Suspension ("TAVT-45"), is an enhanced formulation of abiraterone acetate for the treatment of metastatic prostate cancer. When reconstituted with water or juice to yield an oral suspension, TAVT-45 may provide an alternative for the 20 to 30 percent of patients who suffer from dysphagia or have difficulty swallowing tablets and may increase the bioavailability of abiraterone and therefore allow a lower dose to be administered. In addition to the multiple large tablets required daily, other limitations of Zytiga include the requirement to be taken on an empty stomach and the high variability in systemic exposure. This high variability in systemic exposure has been shown to result in patients with low abiraterone plasma concentrations and exposure, which can lead to suboptimal clinical outcomes.iii,iv It is anticipated that TAVT-45 may be taken regardless of food consumption and may result in fewer patients having sub-optimal abiraterone trough plasma concentrations.

on January 5, 2023 -Pheast Therapeutics, a private biotechnology company developing novel innate immune checkpoint inhibitors to unleash the power of macrophages on aggressive, difficult-to-treat cancers, reported the appointment of Jacopo Leonardi as Chief Executive Officer. Mr. Leonardi brings more than 25 years of executive leadership spanning commercial and research and development (R&D) sectors for global pharmaceutical companies as well as experience in building new companies focused on developing novel therapeutics for high unmet medical needs (Press release, Pheast Therapeutics, JAN 5, 2023, View Source [SID1234625948]).

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Amira Barkal, M.D., Ph.D., principal founder and founding CEO of Pheast Therapeutics, will now serve as Chief Development Officer. Dr. Barkal said, "Pheast will benefit from Jacopo’s expertise in building inclusive, inspired teams that reach the ultimate goal of delivering meaningful therapeutics to patients."

"Jacopo’s proven leadership from biopharmaceutical R&D and commercial strategy to early-stage company creation, as well as his experience in advancing new therapeutics in immunology and oncology, will be instrumental in building the team and translating the breakthrough discovery of CD24 blockade into new immunotherapies," added Irving Weissman, M.D., cofounder of Pheast Therapeutics.

"I am excited to join this team of scientific experts and leaders in the field of cancer immunotherapy and innate immunity responsible for several foundational discoveries of novel, tumor-specific macrophage-activating pathways," said Mr. Leonardi. "I look forward to building a purpose-inspired, high-performing team at Pheast to deliver the next generation of innate immunotherapies and provide better treatment options for patients with aggressive, difficult-to-treat cancers."

Mr. Leonardi serves as a Venture Advisor to Agent Capital and on the Board of Directors of AIS Healthcare and recently served on the Boards of Carbon Biosciences and Pyxis Oncology. Previously, he served in key development and global leadership roles in general management, R&D, new product planning, marketing, and sales at Horizon Therapeutics, Baxalta, Baxter Healthcare, Eli Lilly, and Johnson & Johnson. At Baxalta, Mr. Leonardi was Executive Vice President and President of Immunology and was a member of the Executive Leadership Team that spun Baxalta out of Baxter Healthcare, which was subsequently acquired by Shire PLC.

Pheast completed its Series A financing of $76M in April 2022, led by high profile investors, Catalio Capital Management and Arch Venture Partners. Dr. Jacob Vogelstein, Managing Partner of Catalio and Board Director of Pheast, said, "We have been impressed with the power of Pheast’s discovery platform and the early progress being made to elucidate drug candidates that promote anti-tumor responses via interference with CD24 signaling. We look forward to helping the company take maximum advantage of its discoveries to enable the development of new and powerful approaches to the treatment of cancer."

On January 5, 2023 InnoCare Pharma (HKEX: 09969; SSE: 688428), a leading biopharmaceutical company focusing on the treatment of cancer and autoimmune diseases, reported that the Company will present the latest clinical data of FGFR inhibitor gunagratinib (ICP-192) for the treatment of cholangiocarcinoma at the 2023 American Society of Clinical Oncology (ASCO) (Free ASCO Whitepaper) Gastrointestinal (ASCO GI) Cancers Symposium on January 19-21, 2023, which will be held online and offline in San Francisco, U.S (Press release, InnoCare Pharma, JAN 5, 2023, View Source [SID1234625947]).

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The 2023 ASCO (Free ASCO Whitepaper) GI Cancers Symposium is an influential academic exchange event in the gastrointestinal cancer in the world, offering the latest innovative science, solution-focused strategies, and multidisciplinary approaches in GI cancer treatment, research, and care.

Poster Presentation

Title: Gunagratinib, a highly selective irreversible FGFR inhibitor, in patients with previously treated locally advanced or metastatic cholangiocarcinoma harboring FGFR pathway alterations: A phase IIa dose-expansion study

Abstract Number: 572
Session Title: Poster Session B: Cancers of the Pancreas, Small Bowel, and Hepatobiliary Tract
Presentation Time: 12:00 PM -1:30 PM, Jan. 20, U.S. Time
Presenter: Professor Ye Guo

On January 5, 2023 -Novocure (NASDAQ: NVCR) reported the LUNAR study met its primary endpoint, demonstrating a statistically significant and clinically meaningful improvement in overall survival over standard therapies alone (Press release, NovoCure, JAN 5, 2023, View Source [SID1234625945]). The LUNAR study is a pivotal, open-label, randomized study evaluating the safety and efficacy of Tumor Treating Fields (TTFields) together with standard therapies for stage 4 non-small cell lung cancer (NSCLC) following progression while on or after treatment with platinum-based therapy.

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The LUNAR study also showed a statistically significant and clinically meaningful improvement in overall survival when patients were treated with TTFields and immune checkpoint inhibitors (ICI), as compared to those treated with immune checkpoint inhibitors alone, and a positive trend in overall survival when patients were treated with TTFields and docetaxel versus docetaxel alone. Patient enrollment was well balanced between the ICI and docetaxel cohorts of the experimental and control arms, and control arms performed in line with prior studies. TTFields therapy was well tolerated by patients enrolled in the experimental arm of the study.

"We are pleased with the positive readout of the LUNAR study. Prior to LUNAR, the last phase 3 trial to lead to significant improvement in overall survival in late-stage, platinum-resistant non-small cell lung cancer was six years ago, underlining the difficulty in treating this disease," said William Doyle, Novocure’s Executive Chairman. "We are also pleased by the profound performance of the TTFields together with immunotherapy, which has the potential to meaningfully extend patient survival beyond what was previously possible. I would like to thank our patients and investigators for their courage and dedication in completing LUNAR. And, I would like to thank Novocure’s employees for their unrelenting commitment to patients and their perseverance in propelling Novocure to this major milestone."

Novocure plans to release the full results of the LUNAR study at a future medical conference. Novocure expects to file a Premarket Approval application with the U.S. Food and Drug Administration (FDA) in the second half of 2023. Novocure also expects to file for a CE Mark in the European Union concurrently with the FDA submission.

On January 5, 2023 AngioDynamics, Inc. (NASDAQ: ANGO), a leading and transformative medical technology company focused on restoring healthy blood flow in the body’s vascular system, expanding cancer treatment options and improving quality of life for patients, reported financial results for the second quarter of fiscal year 2023, which ended November 30, 2022 (Press release, AngioDynamics, JAN 5, 2023, View Source [SID1234625944]).

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"We drove strong performance during the second quarter, and we believe our results through the first half of the year position us well to achieve our full-year targets," commented Jim Clemmer, President and Chief Executive Officer of AngioDynamics, Inc. "I am pleased with the way the team has managed through the current macro environment as we continue to execute on our strategy of pursuing attractive markets where our med tech platforms possess a differentiated technology advantage. In addition, I am thrilled that we have surpassed the mid-point of our enrollment target on our Preserve study during the quarter, as we continue to progress toward our goal of offering treatment options aimed at improving quality of life for prostate cancer patients."

Second Quarter 2023 Financial Results

Net sales for the second quarter of fiscal 2023 were $85.4 million, an increase of 9.1% compared to the prior-year quarter. Foreign currency translation did not have a significant impact on the Company’s net sales in the quarter.

Med Tech net sales were $24.5 million, a 29.7% increase from the prior-year period. Med Tech includes the Auryon peripheral atherectomy platform, the thrombus management platform and the NanoKnife irreversible electroporation platform. Growth was driven by Auryon sales during the quarter of $10.1 million, which increased 60.6%, and NanoKnife sales of $5.5 million, which increased 49.5% compared to the second quarter of fiscal 2022. NanoKnife disposable sales were $4.2 million, which increased 45.4% compared to the second quarter of fiscal 2022.

Med Device net sales were $60.9 million, an increase of 2.6% compared to the prior-year period.

U.S. net sales in the second quarter of fiscal 2023 were $71.6 million, an increase of 9.6% from $65.4 million a year ago. International net sales were $13.8 million, an increase of 6.7% compared to a year ago.

Gross margin for the second quarter of fiscal 2023 was 52.8%, an increase of 100 basis points compared to the second quarter of fiscal 2022. Gross margin for the Med Tech business was 63.7%, a decline of 290 basis points from the second quarter of fiscal 2022. Gross margin for the Med Device business was 48.4%, an increase of 130 basis points compared to the second quarter of fiscal 2022. Gross margin was negatively impacted by macro forces including labor shortages and increased costs for labor, raw materials and freight.

The Company recorded a net loss of $8.5 million, or a loss per share of $0.21, in the second quarter of fiscal 2023. This compares to a net loss of $8.4 million, or a loss per share of $0.21, a year ago.

Excluding the items shown in the non-GAAP reconciliation table below, adjusted net income for the second quarter of fiscal 2023 was $0.4 million, and adjusted earnings per share was $0.01, compared to adjusted net loss of $0.9 million and adjusted loss per share of $0.02 in the prior-year period.

Adjusted EBITDA in the second quarter of fiscal 2023, excluding the items shown in the reconciliation table below, was $7.5 million, compared to adjusted EBITDA of $4.4 million in the second quarter of fiscal 2022.

In the second quarter of fiscal 2023, the Company generated $7.5 million in operating cash, had capital expenditures of $1.3 million and had additions to Auryon placement and evaluation units of $1.2 million.

On November 30, 2022, the Company had $29.9 million in cash and cash equivalents, compared to $28.8 million in cash and cash equivalents on May 31, 2022. The Company had $25.0 million outstanding on the delayed-draw term loan and $25.0 million outstanding under its revolving credit facility at November 30, 2022.

Six Months Financial Results

For the six months ended November 30, 2022:

Net sales were $167.0 million, an increase of 7.5%, compared to $155.3 million for the same period a year ago.

Med Tech net sales were $47.3 million, a 29.7% increase from the prior year period. Med Device net sales were $119.6 million, an increase of 0.7% from the prior year period.

Gross margin increased 30 basis points to 52.3% from 52.0% a year ago.

The Company’s net loss was $21.5 million, or a loss of $0.55 per share, compared to a net loss of $15.3 million, or a loss of $0.39 per share, a year ago.

Excluding the items shown in the non-GAAP reconciliation table, below, adjusted net loss was $2.1 million, with adjusted loss per share of $0.05, compared to adjusted net loss and adjusted loss per share of $1.7 million, and $0.04, respectively, a year ago.

Adjusted EBITDA, excluding the items shown in the reconciliation table below, was $10.4 million, compared to $8.0 million for the same period a year ago.

Fiscal Year 2023 Financial Guidance

Management is reaffirming its previously issued fiscal year 2023 guidance. Management expects net sales to be in the range of $342 to $348 million, gross margin to be approximately 52.5% to 54.5% and adjusted earnings per share in the range of $0.01 to $0.06 as it continues to invest in new product launches to drive future growth.

Conference Call

The Company’s management will host a conference call today at 8:00 a.m. ET to discuss its second quarter results.

To participate in the conference call, dial 1-877-407-0784 (domestic) or +1-201-689-8560 (international) and refer to the passcode 13734978.

This conference call will also be webcast and can be accessed from the "Investors" section of the AngioDynamics website at www.angiodynamics.com. The webcast replay of the call will be available at the same site approximately one hour after the end of the call.

A recording of the call will also be available from 11:00 a.m. ET on Thursday, January 5, 2023, until 11:59 p.m. ET on Thursday, January 12, 2023. To listen to this recording, dial 1-844-512-2921 (domestic) or +1-412-317-6671 (international) and enter the passcode 13734978.

Use of Non-GAAP Measures

Management uses non-GAAP measures to establish operational goals and believes that non-GAAP measures may assist investors in analyzing the underlying trends in AngioDynamics’ business over time. Investors should consider these non-GAAP measures in addition to, not as a substitute for or as superior to, financial reporting measures prepared in accordance with GAAP. In this news release, AngioDynamics has reported adjusted EBITDA, adjusted net income and adjusted earnings per share. Management uses these measures in its internal analysis and review of operational performance. Management believes that these measures provide investors with useful information in comparing AngioDynamics’ performance over different periods. By using these non-GAAP measures, management believes that investors get a better picture of the performance of AngioDynamics’ underlying business. Management encourages investors to review AngioDynamics’ financial results prepared in accordance with GAAP to understand AngioDynamics’ performance taking into account all relevant factors, including those that may only occur from time to time but have a material impact on AngioDynamics’ financial results. Please see the tables that follow for a reconciliation of non-GAAP measures to measures prepared in accordance with GAAP.