AIkido Share Repurchase Continues

On October 6, 2022 AIkido Pharma Inc. (Nasdaq: AIKI) ("AIkido" or the "Company") reported an update on the Company’s share repurchase program (the "Share Repurchase Program") authorized by the Company’s Board of Directors on January 21, 2022 (Press release, AIkido Pharma, OCT 6, 2022, View Source [SID1234621803]).

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The Company reported that on October 5, 2022, the Company purchased 10,500 shares of common stock at $7.0679 per share.

Additional shares may be repurchased from time to time in open market transactions, or other means in accordance with Rule 10b5-1 of the Securities Exchange Act of 1934, as amended (the "Exchange Act"), and Rule 10b -18 of the Exchange Act. The timing, number of shares repurchased, and prices paid for the stock under this program will depend on general business and market conditions as well as corporate and regulatory limitations, including blackout period restrictions.

Illumina to Announce Third Quarter 2022 Financial Results on Thursday, November 3, 2022

On October 6, 2022 Illumina, Inc. (NASDAQ: ILMN) reported that it will issue results for the third quarter 2022 following the close of market on Thursday, November 3, 2022 (Press release, Illumina, OCT 6, 2022, View Source [SID1234621802]).

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On the same day, at 2:00 pm Pacific Time (5:00 pm Eastern Time) Francis deSouza, Chief Executive Officer, and Joydeep Goswami, Chief Strategy and Corporate Development Officer and Interim Chief Financial Officer, will host a conference call with analysts, investors, and other interested parties to discuss financial and operating results.

Conference Call Details

The conference call will begin at 2:00 pm Pacific Time (5:00 pm Eastern Time) on Thursday, November 3, 2022. Interested parties may access the live teleconference through the Investor Info section of Illumina’s website at investor.illumina.com. Alternatively, individuals can access the call by dialing 866.409.1555 or +1.313.209.4906 outside North America, both with Conference ID 7679670. To ensure timely connection, please dial in at least ten minutes before the scheduled start of the call.

A replay of the conference call will be posted on Illumina’s website after the event and will be available for at least 30 days following.

Citius Pharmaceuticals to Present at Dawson James Securities Small Cap Growth Conference on October 12, 2022

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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Tempus Announces Companion Diagnostic Collaboration with Kartos Therapeutics

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."

AngioDynamics Reports Fiscal 2023 First Quarter Financial Results; Reaffirms Guidance

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.