The Company is responsible for preparing, filing, prosecuting, and maintaining all patent applications and patents included in the licensed patents that we intend to pursue within the territory. Obligations to Dr. Reddy's under the Asset Purchase Agreement 10 Also under the agreement with Dr. Reddy's, the Company is required to (i) use commercially reasonable efforts to make commercially available products in the CTCL indication, peripheral T-cell lymphoma indication and immuno-oncology indication, (ii) ini ...

The Company continues to invest in capability with the goal of reducing production bottlenecks and driving productivity, including investments in automation, laser welding, and the construction of additional integrated conditioning capacity. The Company also constructed a SureSource 1500 in Torrington during fiscal year 2022, which operates as a testing facility for qualifying new supplier components and performance testing and validation of continued platform innovations, including carbon recovery. During ...

UNITED STATES SECURITIES AND EXCHANGE COMMISSION WASHINGTON, D.C. 20549 ☒ ANNUAL REPORT PURSUANT TO SECTION 13 OR 15(d) OF THE SECURITIES EXCHANGE ACT OF 1934 For the fiscal year ended September 30, 2024 OR ☐ TRANSITION REPORT PURSUANT TO SECTION 13 OR 15(d) OF THE SECURITIES EXCHANGE ACT OF 1934 For the transition period from to Commission File Number: 001-37759 Delaware 38-3982704 (State or other jurisdiction of incorporation or organization) (I.R.S. Employer Identification No.) Exchange Commission not la ...

WASHINGTON D.C. 20549 | --- | --- | --- | |------------------|------------------------|----------------------| | | September 28, 2024 | September 30, 2023 | | All items | 2.4 % | 3.7 % | | Food at home | 1.3 % | 2.4 % | | Energy | (6.8) % | (0.5) % | 12 We believe our success depends, in substantial part, on our ability to: SECURITIES AND EXCHANGE COMMISSION (Exact name of registrant as specified in its charter) 2913 U.S. Hwy. 70 West, Black Mountain, NC 28711 (Address of principal executive offices) (Zip C ...

As a result of discontinuing our retail reportable segment, we now have two reportable segments: OEM distribution and design. The OEM distribution segment sources and distributes carrying cases and other accessories for medical monitoring and diagnostic kits and a variety of other portable electronic and non-electronic devices directly to OEMs or their contract manufacturers worldwide. The design segment consists of two operating segments (IPS and Kablooe, which have been aggregated into one reportable segm ...

UNITED STATES SECURITIES AND EXCHANGE COMMISSION FORM 10-K Washington, D.C. 20549 The material weaknesses identified above did not result in any material misstatements in our financial statements or disclosures, and there were no changes to previously released financial results. However, as a result of this finding, during the first quarter of our fiscal year 2025, we began the process of addressing these material weaknesses to our ITGCs. 38 Apart from the changes discussed above we have not made any additi ...

Financial Position and Risks - Advent had an unrestricted cash balance of approximately $0.2 million as of September 30, 2024[373] - Advent is exposed to market risks including changes in interest rates, inflation, and foreign exchange fluctuations, with plans to implement foreign exchange risk mitigation features as the company scales[386] - Advent's management identified material weaknesses in internal control over financial reporting as of September 30, 2024, leading to ineffective disclosure controls and procedures[374] - Advent's deferred tax assets and liabilities are measured using enacted tax rates, with valuation allowances established to reduce deferred tax assets to the amount expected to be realized[377] Research and Development - The RHyno project aims to develop innovative fuel cells and electrolysers at a megawatt (MW) scale, focusing on enhancing power density and lifespan while reducing weight and volume[15] - Advent expects to continue receiving grant income for research and development activities and is in discussions with prospective grantors[406] Technology and Products - Advent's HT-PEM MEAs operate at temperatures higher than 180°C (360°F), targeting improved performance for aviation, heavy-duty trucks, automotive, and marine use[402] - Advent's Honey Badger fuel cell technology is designed to meet the U.S. Department of Defense's needs for lightweight, portable power solutions[404] Strategic Expansion - Advent's acquisition of SerEnergy A/S and fischer eco solutions GmbH was completed on June 25, 2021, as part of its strategic expansion[392] Non-GAAP Measures - Advent's non-GAAP measures include EBITDA, Adjusted EBITDA, and Adjusted Net Income / (Loss), used to evaluate operating performance and compare with peers[381]

Product Development and Approvals - LYTENAVA™ is the first and only approved ophthalmic formulation of bevacizumab for the treatment of wet AMD in the EU and UK, with the first commercial launch anticipated in H1 CY25[2] - The company plans to resubmit the BLA for ONS-5010 in Q1 CY2025, with final efficacy data from NORSE EIGHT expected in January 2025[6][9] - Initial commercial launches of LYTENAVA™ in Europe are planned to commence in H1 CY2025[6] - Potential US FDA approval of ONS-5010 is anticipated in H2 CY2025[6] Financial Performance - Outlook Therapeutics had cash and cash equivalents of $14.9 million as of September 30, 2024[10] - The company reported a net loss of $75.4 million, or $4.06 per basic and diluted share, for the fiscal year ended September 30, 2024, compared to a net loss of $59.0 million, or $4.72 per basic and diluted share, for the prior fiscal year[18] - Research and development expenses increased to $41.8 million in FY2024 from $26.5 million in FY2023[23] - General and administrative expenses increased to $29.9 million in FY2024 from $26.7 million in FY2023[23] - Total assets decreased to $28.8 million as of September 30, 2024, from $32.3 million as of September 30, 2023[24] - Total stockholders' deficit increased to $73.1 million as of September 30, 2024, from $14.4 million as of September 30, 2023[24]

Delaware 001-37370 51-0394637 (State or other jurisdiction of incorporation) (Commission File Number) (IRS Employer Identification No.) FORM 8-K Pursuant to Section 13 OR 15(d) of the Securities Exchange Act of 1934 MY SIZE, INC. (Exact name of registrant as specified in its charter) Registrant's telephone number, including area code +972-3-600-9030 Check the appropriate box below if the Form 8-K filing is intended to simultaneously satisfy the filing obligation of the registrant under any of the following ...

UNITED STATES SECURITIES AND EXCHANGE COMMISSION Washington, D.C. 20549 FORM 8-K CURRENT REPORT Pursuant to Section 13 OR 15(d) of The Securities Exchange Act of 1934 Date of Report (Date of earliest event reported) October 28, 2024 INGLES MARKETS, INCORPORATED (Exact name of registrant as specified in its charter) | --- | --- | --- | |-----------------------------------------------------|------------------------------|---------------------| | North Carolina | 0-14706 | 56-0846267 | | (State or other jurisd ...