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.

On October 6, 2022 Scholar Rock (NASDAQ: SRRK), a Phase 3, clinical-stage biopharmaceutical company focused on the treatment of serious diseases in which protein growth factors play a fundamental role, reported it will present data from DRAGON, a Phase 1 proof-of-concept study of SRK-181 in patients with advanced solid tumors (Press release, Scholar Rock, OCT 6, 2022, View Source [SID1234621796]). Safety, efficacy, and biomarker results from Part A (dose escalation) and an update on Part B (dose expansion) will be presented as a poster at the Society for Immunotherapy of Cancer (SITC) (Free SITC Whitepaper)’s (SITC) (Free SITC Whitepaper) 37th Annual Meeting in Boston on November 8-12.

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"We are encouraged by the early clinical data from the ongoing DRAGON Phase 1 clinical trial and look forward to sharing these results at SITC (Free SITC Whitepaper), as well as at future medical meetings as more SRK-181 data from both Part A and B become available," said Nagesh Mahanthappa, Founding and Interim Chief Executive Officer of Scholar Rock. "With a novel mechanism of action and encouraging preclinical and clinical data to date, we believe that SRK-181 has promising potential for the treatment of a variety of cancers that are resistant to checkpoint inhibitors."

SRK-181 is an investigational selective inhibitor of latent TGFβ1 activation and is being developed with the aim of overcoming primary resistance to checkpoint therapy in advanced cancer patients. Combination therapy with selective TGFβ1 blockade may modulate the tumor microenvironment, allowing for immune cell infiltration and potential improvements in the response rate and survival time of cancer patients.

Details of the presentations are as follows:

Title: SRK-181, a latent TGFβ1 inhibitor: safety, efficacy, and biomarker results from the dose escalation portion of a phase I trial (DRAGON trial) in patients with advanced solid tumors
Presentation Type: Poster 780
Presenter: Timothy Yap, MBBS, PhD, FRCP, Medical Oncologist and Physician-Scientist; and Associate Professor, Department of Investigational Cancer Therapeutics, University of Texas MD Anderson Cancer Center
Location: Poster Hall
Date/Time: November 10-11, 9 a.m. to 9 p.m. ET

The abstract for this presentation is available on SITC (Free SITC Whitepaper)’s website: www.sitcancer.org/2022/abstracts/abstract-titles-publications

The presentation will be made available in the Publications & Posters section of Scholar Rock’s website following the conference.

For conference information, visit www.sitcancer.org/2022/program/annual-meeting

About SRK-181

SRK-181 is a selective inhibitor of TGFβ1 activation being developed to overcome primary resistance to checkpoint inhibitor therapy, such as anti-PD-(L)1 antibodies, in advanced cancer. TGFβ1 is the predominant TGFβ isoform expressed in many human tumor types. Based on analyses of various human tumors that are resistant to anti-PD-(L)1 therapy, data suggest TGFβ1 is a key contributor to the immunosuppressive tumor microenvironment, excluding and preventing entry of cytotoxic T cells into the tumor, thereby inhibiting anti-tumor immunity.(1) Scholar Rock believes SRK-181, which specifically targets the latent TGFβ1 isoform, has the potential to overcome this immune cell exclusion and induce tumor regression when administered in combination with anti-PD-(L)1 therapy while potentially avoiding toxicities associated with non-selective TGFβ inhibition. The DRAGON Phase 1 proof-of-concept clinical trial (NCT04291079) in patients with locally advanced or metastatic solid tumors is ongoing. The trial is currently enrolling and dosing patients in multiple proof of concept cohorts conducted in parallel, including urothelial carcinoma (UC), cutaneous melanoma (MEL), non-small cell lung cancer (NSCLC) and clear cell renal cell carcinoma (ccRCC). SRK-181 is an investigational product candidate and its efficacy and safety have not been established. SRK-181 has not been approved for any use by the FDA or any other regulatory agency.

On October 6, 2022 Mustang Bio, Inc. ("Mustang") (Nasdaq: MBIO), a clinical-stage biopharmaceutical company focused on translating today’s medical breakthroughs in cell and gene therapies into potential cures for hematologic cancers, solid tumors and rare genetic diseases, reported that the first patient has been treated in its multicenter, open-label, non-randomized Phase 1/2 clinical trial evaluating the safety and efficacy of MB-106, Mustang’s first-in-class CD20-targeted, autologous CAR T cell therapy for the treatment of relapsed or refractory B-cell non-Hodgkin lymphomas ("B-NHL") and chronic lymphocytic leukemia ("CLL") (Press release, Mustang Bio, OCT 6, 2022, View Source [SID1234621794]). The patient did not experience cytokine release syndrome ("CRS") or immune effector cell-associated neurotoxicity syndrome ("ICANS"). MB-106 is being developed in a collaboration between Mustang and Fred Hutchinson Cancer Center ("Fred Hutch"). The multicenter trial under Mustang’s Investigational New Drug Application ("IND") builds upon the initial, ongoing Phase 1/2 clinical trial taking place at Fred Hutch in a single-center study under Fred Hutch’s IND.

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Manuel Litchman, M.D., President and Chief Executive Officer of Mustang said, "The first clinical trial under Mustang’s IND is an important milestone in the ongoing development and evaluation of MB-106. Data presented at several prestigious medical meetings earlier this year from the initial, ongoing Phase 1/2 clinical trial at Fred Hutch show that MB-106 continues to demonstrate high efficacy and a favorable safety profile across patients with a wide range of hematologic malignancies. We look forward to providing updates on our multicenter MB-106 clinical trial as it progresses and anticipate reporting efficacy data in the fourth quarter of this year."

Interim data from 28 patients treated in the initial, ongoing Phase 1/2 investigator-sponsored clinical trial at Fred Hutch continue to support MB-106 as a viable CAR T cell therapy for B-NHLs and CLL. As of September 9, 2022, the interim data show:

An overall response rate of 96% and complete response ("CR") rate of 75% in a wide range of hematologic malignancies including follicular lymphoma ("FL"), CLL, diffuse large B-cell lymphoma, and Waldenstrom macroglobulinemia
Twelve patients have experienced CR for more than 12 months (10 ongoing); four patients with CR for more than two years and the longest patient with CR is at 33 months
Six patients with partial response ("PR") improved to CR and all remain in ongoing CR
All three patients previously treated with CD19 CAR T cell therapy have responded to treatment with MB-106
A favorable safety profile for MB-106 as an outpatient therapy remains with no CRS or ICANS ≥ Grade 3
CAR-T persistence results in deepening responses following initial 28-day assessments
"We are excited to broaden the evaluation of MB-106 with this multicenter clinical trial under Mustang’s IND. To date, the data from the initial, ongoing clinical trial at Fred Hutch continue to demonstrate a high rate of complete and durable responses," said Mazyar Shadman, M.D., M.P.H., Study Chair, Associate Professor and physician at Fred Hutch and University of Washington. "In addition, MB-106 has shown potential to treat patients in an outpatient setting and provide another immunotherapy option for patients treated previously with CD19-directed CAR T cell therapy."

About Mustang’s Multicenter MB-106 Phase 1/2 clinical trial
The six-center Phase 1/2 clinical trial is a three-arm study targeting CLL and B-NHL including FL, diffuse large B-cell lymphoma and mantle cell lymphoma. Included in the eligibility criteria are patients who have relapsed after treatment with CD19 CAR-T cell therapy. Additionally, the FL arm will evaluate other indolent histologies including Waldenstrom macroglobulinemia, a rare type of B-NHL for which the U.S. Food and Drug Administration recently granted MB-106 Orphan Drug Designation. Since the Mustang-sponsored multicenter clinical trial is using the same lentiviral vector as the Fred Hutch-sponsored single-center trial, the FDA has allowed dose escalation to begin at a higher dose than what was originally conducted at Fred Hutch.

An estimated 287 patients are anticipated to be enrolled in the trial. All patients must have evidence of CD20 expression in both phases of the clinical trial. In Phase 1, escalating MB-106 dose levels will be tested independently in each arm using a 3+3 design. Patients will be enrolled in one of three arms, based on their primary diagnosis.

A total of up to 18 patients are anticipated to be treated in each Phase 1 arm, including six patients at the maximum tolerated dose, prior to proceeding to the Phase 2 portion of the study for each respective arm, where a total of up to 71 patients will participate in each independent arm. Safety of each dose level will be reviewed for each arm until the maximum tolerated dose has been reached and the recommended Phase 2 dose ("RP2D") has been established for each arm. An assessment of the safety and tolerability of the dose will be made by the Safety Review Committee based on the data from the 28-day dose-limiting toxicity observation period.

In Phase 2, specific arms of relapsed or refractory CD20-positive B-cell NHL or CLL patients will be treated with MB-106 at the respective RP2D for each arm. Each arm will initially include up to 20 patients. Based on the results of the interim analysis, up to an additional 51 patients may be added to each of the arms.

Additional information about the trial can be found on clinicaltrials.gov using the identifier NCT05360238.

About MB-106 (CD20-targeted autologous CAR T Cell Therapy)
CD20 is a membrane-embedded surface molecule which plays a role in the differentiation of B-cells into plasma cells. The CAR T was developed by Mustang’s research collaborator, Fred Hutch, in the laboratories of the late Oliver Press, M.D., Ph.D., and Brian Till, M.D., Associate Professor in the Clinical Research Division at Fred Hutch, and was exclusively licensed to Mustang in 2017. The lentiviral vector drug substance used to transduce patients’ cells to create the MB-106 drug product produced at Fred Hutch has been optimized as a third-generation CAR derived from a fully human antibody. MB-106 is currently in a Phase 1/2 open-label, dose-escalation trial at Fred Hutch in patients with B-NHLs and CLL. The same lentiviral vector drug substance produced at Fred Hutch will be used to transduce patients’ cells to create the MB-106 drug product produced at Mustang Bio’s Worcester, MA, cell processing facility for administration in the multicenter Phase 1/2 clinical trial under Mustang Bio’s IND. It should be noted that Mustang Bio has introduced minor improvements to its cell processing to facilitate eventual commercial launch of the product. In addition, prior to commercial launch, Mustang Bio will replace the Fred Hutch lentiviral vector drug substance with vector produced at a commercial manufacturer. Additional information on these trials can be found at View Source using the identifier NCT05360238 for the Mustang multicenter trial and NCT03277729 for the ongoing trial at Fred Hutch.