On October 6, 2022 Citius Pharmaceuticals, Inc. ("Citius" or the "Company") (NASDAQ: CTXR), a late-stage biopharmaceutical company developing and commercializing first-in-class critical care products, reported that Chairman and CEO Leonard Mazur will be presenting at the Dawson James Securities Small Cap Growth Conference on October 12, 2022 (Press release, Citius Pharmaceuticals, OCT 6, 2022, View Source [SID1234621801]).

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On October 6, 2022 Tempus, a leader in artificial intelligence and precision medicine, reported a new collaboration to develop a companion diagnostic (CDx) test with Kartos Therapeutics, a clinical stage biopharmaceutical company, in support of its ongoing Phase II study of navtemadlin (KRT-232) (Press release, Tempus, OCT 6, 2022, View Source [SID1234621800]). Tempus’ CDx test, which will be developed on Tempus’ xT platform, will be used to identify patients with TP53 wild-type (TP53WT) Merkel cell carcinoma (MCC) who may be eligible for treatment with navtemadlin. Navtemadlin is a potent, selective, orally available MDM2 inhibitor that overcomes MDM2 dysregulation by restoring p53 activity and inducing apoptosis of TP53WT tumor cells.

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Although rare, MCC is one of the most aggressive and lethal types of skin cancer, associated with a high risk of recurrence and metastasis, making it very difficult to treat. While anti-PD-1/L-1 antibodies have become standard of care for advanced or metastatic MCC, there remains an urgent need for effective therapies for patients who fail to respond, relapse or are intolerant to immunotherapy. Kartos is collaborating with Tempus to use the xT assay, a 648-gene panel, to identify patients with advanced or metastatic MCC who have retained functional (wild-type) TP53 and who have failed or are intolerant to anti-PD-1/L-1 immunotherapy.

"We are pleased to be collaborating with the Tempus team to progress our goal of developing innovative therapies that meaningfully improve the lives of patients," said Jesse McGreivy, MD, Chief Executive Officer and Chief Medical Officer at Kartos Therapeutics. "This partnership will allow us to develop a test to identify cancer patients who may benefit from treatment with navtemadlin; a therapy which offers a unique mechanism to restore the function of p53, one of the most critical tumor suppressor proteins, resulting in apoptosis of malignant cells in TP53WT MCC and other tumor types."

"Our proprietary platform provides a comprehensive suite of solutions for novel drug development programs while also giving physicians the data needed to make informed treatment decisions for their patients," said Michael Yasiejko, Executive Vice President at Tempus. "We look forward to supporting Kartos’ diagnostic efforts in identifying cancer patients who could benefit from a more personalized approach to their treatment using a widely-available assay and clinician-friendly tools."

On October 6, 2022 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 first quarter of fiscal year 2023, which ended August 31, 2022 (Press release, AngioDynamics, OCT 6, 2022, View Source [SID1234621799]).

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"We are pleased with our performance during the quarter as we continued to deliver on our long-term strategic objectives," commented Jim Clemmer, President and Chief Executive Officer of AngioDynamics, Inc. "The challenging and uncertain macro environment continued during our first fiscal quarter of 2023, with persistent inflation, as well as hospital staffing and procedural pressures. Our commitment to executing our strategic plan based on our key growth drivers: Auryon, AngioVac, AlphaVac and NanoKnife, enabled us to build on the momentum we generated in fiscal 2022 to deliver solid results even in the face of this challenging environment."

First Quarter 2023 Financial Results

Net sales for the first quarter of fiscal 2023 were $81.5 million, an increase of 5.9% 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 $22.8 million, a 29.6% 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 $8.8 million, which increased 50.0%, thrombectomy sales of $10.0 million, which increased 31.8% and NanoKnife disposable sales, which increased 12.3% compared to the first quarter of fiscal 2022.

Med Device net sales were $58.7 million, a decline of 1.1% compared to the prior-year period.

U.S. net sales in the first quarter of fiscal 2023 were $69.0 million, an increase of 7.1% from $64.5 million a year ago. International net sales were $12.5 million roughly flat compared to a year ago.

Gross margin for the first quarter of fiscal 2023 was 51.9%, a decrease of 20 basis points compared to the first quarter of fiscal 2022. Gross margin for the Med Tech business was 63.2%, a decline of 220 basis points from the first quarter of fiscal 2022. Gross margin for the Med Device business was 47.5%, a decline of 70 basis points compared to the first 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 $13.0 million, or a loss per share of $0.33, in the first quarter of fiscal 2023. This compares to a net loss of $7.0 million, or a loss per share of $0.18, a year ago.

Excluding the items shown in the non-GAAP reconciliation table below, adjusted net loss for the first quarter of fiscal 2023 was $2.5 million, and adjusted loss per share was $0.06, 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 first quarter of fiscal 2023, excluding the items shown in the reconciliation table below, was $3.0 million, compared to adjusted EBITDA of $3.6 million in the first quarter of fiscal 2022.

In the first quarter of fiscal 2023, the Company used $24.7 million in operating cash, had capital expenditures of $0.8 million and additions to Auryon placement and evaluation units of $2.2 million.

On August 31, 2022, the Company had $24.6 million in cash and cash equivalents, compared to $28.8 million in cash and cash equivalents on May 31, 2022.

During the first quarter, the Company refinanced its credit facility. The new credit facility provides for a $75 million secured revolving credit facility with a maturity date of August 30, 2027 and a $30 million delayed-draw term loan. The proceeds of the delayed-draw term loan may be used for general corporate purposes, including primarily to finance the manufacturing costs of the Auryon laser capital equipment of AngioDynamics and its subsidiaries. The Company had $25.0 million outstanding on the delayed-draw term loan and $25.0 million outstanding under its revolving credit facility at August 31, 2022.

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 first 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 13732702.

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, October 6, 2022, until 11:59 p.m. ET on Thursday, October 13, 2022. To listen to this recording, dial 1-844-512-2921 (domestic) or +1-412-317-6671 (international) and enter the passcode 13732702.

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.

On October 6, 2022 MAIA Biotechnology, Inc., (NYSE American: MAIA) ("MAIA", the "Company"), a targeted therapy, immuno-oncology company focused on developing potential first-in-class oncology drugs, reported that the management team will participate in the ThinkEquity Conference (Press release, MAIA Biotechnology, OCT 6, 2022, View Source [SID1234621798]).

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The MAIA team is scheduled to present on Wednesday, October 26th at 3:00 pm ET and will host investor meetings at the Conference.

A webcast of the presentation will be available on the News & Events page of the Investors section of the Company’s website. A replay of the webcast will be available for 30 days following the event.

On October 6, 2022 Biocept, Inc. (Nasdaq: BIOC), a leading provider of molecular diagnostic assays, products and services, reported an hour-long webinar to be held October 14 at 1 p.m. Eastern time featuring case studies presented by leading neuro-oncologists who have used the company’s CNSide assay in the management of patients with confirmed or suspected central nervous system metastasis (Press release, Biocept, OCT 6, 2022, View Source [SID1234621797]). The webinar will feature key opinion leaders Priya U. Kumthekar, MD of Northwestern University and Seema A. Nagpal, MD of Stanford University.

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"Our goals are to position Biocept as the leader in the emerging category of neurological tumor diagnostics, and to become the provider of choice for biopharma companies seeking to develop therapies to treat cancer that has metastasized to the central nervous system"

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"We appreciate Drs. Kumthekar and Nagpal’s willingness to share their real-world clinical experience with CNSide, in managing patients with a time-sensitive, life-threatening complication of cancer," said Michael Dugan, MD, Biocept’s Senior Vice President, Chief Medical Officer and Medical Director. "CNSide provides an enhanced method of cell capture with digital imaging for the quantitative evaluation of tumor cells recovered from cerebral spinal fluid (CSF). This provides a more accurate method of assessing the intracranial response to treatment than more subjective methods currently used to evaluate metastatic cancers involving the central nervous system. Additionally, CNSide can be used to identify biomarkers associated with tumor progression and metastasis to better inform physician treatment decisions and patient care plans, while providing tumor cell counts that can be used by them to more quickly assess both treatment response and disease progression or resistance to treatment."

"Our goals are to position Biocept as the leader in the emerging category of neurological tumor diagnostics, and to become the provider of choice for biopharma companies seeking to develop therapies to treat cancer that has metastasized to the central nervous system," said Sam Riccitelli, Biocept’s Chairman and interim CEO. "Our customer base has consistently grown since CNSide’s early access commercial launch in early 2020. More than 100 physicians including physicians from more than one-third of the elite 64 National Cancer Institute-designated cancer centers have used our product. We estimate the annual market opportunity for CNSide for our initial applications at $1.2 billion in the U.S. and $2 billion globally."

About the Speakers

Priya U. Kumthekar, MD is a United Counsel for Neurologic Subspecialties (UCNS)-certified neuro-oncologist from Northwestern University and is serving as the principal investigator for Biocept’s FORESEE clinical study. She is dedicated to patient care and moving the study of brain tumors forward primarily through her leadership on clinical trials. Dr. Kumthekar serves in leadership roles with the National Clinical Trials Network, particularly with the Alliance for Clinical Trials, and was named as the Alliance’s national Executive Officer of Neuro-Oncology in 2016. In this role, she oversees the conception and development of clinical trials from early phase through registration studies. Dr. Kumthekar is board certified in neurology and is a member of the American Board of Psychiatry and Neurology. She received her medical degree from Northeastern Ohio University. She previously was Chief Resident at Northwestern University, McGaw Medical Center and has led numerous trials involving primary and secondary brain tumors.

Seema A. Nagpal, MD is a board-certified neuro-oncologist and has served as Clinical Associate Professor at Stanford University since 2012. She treats patients with primary brain tumors and metastatic disease to the brain and nervous system. Her research concentrates on clinical trials for patients with late-stage central nervous system cancer and she has a special interest in leptomeningeal disease, a devastating complication of lung and breast cancers. In collaboration with Stanford scientists, including breast and lung oncologists, Dr Nagpal’s work is focused on more sensitive disease detection and the improvement of patient outcomes. She previously was a neuro-oncology fellow at Stanford hospitals and clinics, and a neurology resident at the University of California San Francisco. She received her medical degree from the University of Pennsylvania.