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NEW YORK, Oct. 17, 2024 /PRNewswire/ -- Pomerantz LLP announces that a class action lawsuit has been filed against Allarity Therapeutics, Inc. ("Allarity" or the "Company") (NASDAQ: ALLR) and certain officers. The class action, filed in the United States District Court for the Southern District of New York, and docketed under 24-cv-06952, is on behalf of a class consisting of all persons and entities other than Defendants that purchased or otherwise acquired Allarity securities bet ween May 17, 2022 and July 19, 2024, both dates inclusive (the "Class Period"), seeking to recover damages caused by Defendants' violations of the federal securities laws and to pursue remedies under Sections 10(b) and 20(a) of the Securities Exchange Act of 1934 (the "Exchange Act") and Rule 10b-5 promulgated thereunder, against the Company and certain of its top officials. If you are a shareholder who purchased or otherwise acquired Allarity securities during the Class Period, you have until November 12, 2024 to ask the Court to appoint you as Lead Plaintiff for the class. A copy of the Complaint can be obtained at . To discuss this action, contact Danielle Peyton at [email protected] or 646-581-9980 (or 888.4-POMLAW), toll-free, Ext. 7980. Those who inquire by e-mail are encouraged to include their mailing address, telephone number, and the number of shares purchased. [Click here for information about joining the class action] Allarity is a clinical-stage biopharmaceutical company that develops oncology therapeutics using drug-specific companion diagnostics generated by its Drug Response Predictor technology. Allarity's drug candidates include, inter alia, Dovitinib, a pan-tyrosine kinase inhibitor for the treatment of renal cell carcinoma ("RCC"). The Company's companion diagnostic technology for Dovitinib is referred to as "DRP®-Dovitinib" or "Dovitinib-DRP." On April 2, 2021, Allarity's predecessor parent corporation, Allarity Therapeutics A/S, announced that it had submitted a premarket approval application ("PMA") to the U.S. Food and Drug Administration ("FDA") for Dovitinib-DRP (the "Dovitinib-DRP PMA"). On December 22, 2021, Allarity issued a press release announcing that it had submitted a new drug application ("NDA") to the FDA seeking marketing approval for Dovitinib for the third-line treatment of RCC patients (the "Dovitinib NDA"). On February 18, 2022, Allarity issued a press release announcing that it had received Refusal to File ("RTF") letters from the FDA for the Dovitinib NDA and the Dovitinib-DRP PMA because "the NDA . . . and the PMA application . . . were not sufficiently complete to permit substantive reviews," noting that "the FDA's cited reasons for the RTF decision primarily include[d], but [we]re not limited to, that submitted clinical trial data do not enable a conclusion of efficacy based on non-inferiority data set" and that, because "the PMA and NDA were filed as related applications, the RTFs also apply to the DRP®-Dovitinib companion diagnostic." Following these developments, Allarity continued to represent to investors and the market that it remained committed to pursuing the Dovitinib NDA and would work with the FDA to determine a clear regulatory path forward for resubmitting that application. The Complaint alleges that, throughout the Class Period, Defendants made materially false and misleading statements regarding the Company's business, operations, and compliance policies. Specifically, Defendants made false and/or misleading statements and/or failed to disclose that: (i) Defendants had overstated the Dovitinib NDA's continued regulatory prospects; (ii) Allarity and three of its former officers had engaged in illegal, illicit, and/or otherwise improper conduct in connection with the Dovitinib NDA and/or the Dovitinib-DRP PMA; (iii) the foregoing misconduct subjected the Company to an increased risk of regulatory and/or governmental scrutiny and enforcement action, as well as significant legal, monetary, and reputational harm; (iv) following Allarity's announcement that it was, in fact, being investigated for wrongdoing in connection with the Dovitinib NDA and/or the Dovitinib-DRP PMA, the Company downplayed the substantial likelihood that an enforcement action would result from such investigation; and (v) as a result, the Company's public statements were materially false and misleading at all relevant times. On June 29, 2022, Allarity issued a press release announcing that, "[e]ffective immediately," it had appointed Defendant James G. Cullem ("Cullem"), the Company's then-current Chief Business Officer, as its interim Chief Executive Officer ("CEO"), and Defendant Joan Y. Brown ("Brown"), the Company's then-current Director of Financial Reporting, as its interim Chief Financial Officer ("CFO"), and that its former CEO Defendant Steve R. Carchedi ("Carchedi") and former CFO Defendant Jens Knudsen ("Knudsen") had both purportedly "stepped down from those roles to pursue other opportunities." The next day, Allarity disclosed in an U.S. Securities and Exchange Commission ("SEC") filing that Defendants Carchedi and Knudsen had either "resigned" or been "terminat[ed]" from all positions with the Company and its subsidiaries, while indicating that such "resignation" or "termination" may have been for cause, but without clarifying the same. Following these disclosures, Allarity's stock price fell $0.31 per share, or 19.02%, to close at $1.32 per share on June 30, 2022. On August 2, 2022, Allarity issued a press release announcing that "its Board of Directors has mandated a refocus of the Company's oncology pipeline strategy away from development of monotherapies" and, accordingly, "determined that advancing dovitinib as a monotherapy in adults is no longer commercially viable or in the best interests of its shareholders," citing "feedback that the Company recently received from the [FDA] from a Type C advisory meeting held in Q2 2022, regarding a potential Phase 3 clinical development path for dovitinib as a monotherapy third-line treatment for metastatic [RCC]." Accordingly, the Company would no longer pursue the Dovitinib NDA, which sought approval of Dovitinib as a monotherapy. On this news, Allarity's stock price fell $0.045 per share, or 3.688%, to close at $1.175 per share on August 2, 2022. On February 6, 2023, Allarity disclosed in an SEC filing that, "[i]n January 2023, we received a letter to produce documents from the SEC and that stated that the staff of the SEC is conducting an investigation . . . to determine if violations of the federal securities laws have occurred" in connection with "disclosures relating to submissions, communications and meetings with the FDA regarding our NDA for Dovitinib or Dovitinib-DRP." On this news, Allarity's stock price fell $0.009 per share, or 3.8%, to close at $0.228 per share on February 6, 2023. On December 11, 2023, Allarity disclosed in another SEC filing that, "[o]n December 8, 2023, [Defendant] Cullem was terminated as [CEO] of Allarity . . . and all other positions with the Company and its subsidiaries" and that Defendant Thomas Jensen had been appointed as the Company's new CEO on the same date. On this news, Allarity's stock price fell $0.075 per share, or 13.37%, to close at $0.486 per share on December 11, 2023. Then, on July 22, 2024, Allarity disclosed in yet another SEC filing that it had received a Wells Notice from the SEC's staff "relating to the Company's previously disclosed SEC investigation," advising that "[t]he Wells Notice relates to the Company's disclosures regarding meetings with the [FDA] regarding the Company's NDA for Dovitinib or Dovitinib-DRP, which was submitted to the FDA in 2021"; that, per the Company's understanding, "all conduct relating to the SEC Wells Notice occurred during or prior to fiscal year 2022"; and "that three of its former officers"—the same number of Company officers terminated during the Class Period—"received Wells Notices from the SEC relating to the same conduct." On this news, Allarity's stock price fell $0.004 per share, or 2.38%, to close at $0.164 per share on July 22, 2024. Finally, on September 13, 2024, Allarity disclosed in yet another SEC filing that, "[o]n September 12, 2024, the Company received a notice of resignation from [Defendant] Brown, its [CFO], effective September 12, 2024." Pomerantz LLP, with offices in New York, Chicago, Los Angeles, London, Paris, and Tel Aviv, is acknowledged as one of the premier firms in the areas of corporate, securities, and antitrust class litigation. Founded by the late Abraham L. Pomerantz, known as the dean of the class action bar, Pomerantz pioneered the field of securities class actions. Today, more than 85 years later, Pomerantz continues in the tradition he established, fighting for the rights of the victims of securities fraud, breaches of fiduciary duty, and corporate misconduct. The Firm has recovered billions of dollars in damages awards on behalf of class members. See . Attorney advertising. Prior results do not guarantee similar outcomes. CONTACT: Danielle Peyton Pomerantz LLP [email protected] 646-581-9980 ext. 7980 SOURCE Pomerantz LLP WANT YOUR COMPANY'S NEWS FEATURED ON PRNEWSWIRE.COM? 440k+ Newsrooms & Influencers 9k+ Digital Media Outlets 270k+ Journalists Opted In GET STARTED

Fourth Quarter and Recent Business Highlights: Achieved revenue of $93.7 million in the fourth quarter of 2023 versus $79.4 million in the fourth quarter of 2022, an increase of 18% on a GAAP basis and 15% on a non-GAAP constant currency basis Achieved revenue of $354.0 million for the full year of 2023 versus $313.8 million for the full year of 2022, an increase of 13% on a GAAP basis and 12% on a non-GAAP constant currency basis Net loss was ($4.0) million or ($0.10) per fully diluted share and non-GAAP net income was $4.6 million or $0.11 per fully diluted share in the fourth quarter of 2023 Non-GAAP adjusted EBITDA increased 40% to $15.3 million in the fourth quarter of 2023 compared to $11.0 million in the fourth quarter of 2022. For the full year adjusted EBITDA increased 29.5% to $53.8 million Generated $11.4 million of free cash flow for the full year of 2023 Closed non-dilutive credit agreement for $350.0 million of senior secured, interest-only, credit facilities with 6-year maturities Completed enrollment of the AMDS PERSEVERE clinical trial and presented positive results of the full IDE cohort at the STS Annual Meeting demonstrating a significant reduction of all-cause mortality and primary major adverse events (MAEs) at 30-days following AMDS implantation Appointed Lance A. Berry as Executive Vice President and Chief Financial Officer ATLANTA, Feb. 15, 2024 /PRNewswire/ -- Artivion, Inc. (NYSE: AORT), a leading cardiac and vascular surgery company focused on aortic disease, today announced financial results for the fourth quarter and full year ended December 31, 2023. "2023 was a standout year for Artivion as we exceeded our revenue and adjusted EBITDA growth targets and continued to deliver on our mission to enhance our world class, aortic focused company with a highly differentiated product portfolio and global footprint. Revenue growth in the fourth quarter was strong across all four of our product lines and all four geographies, driven by particularly strong performance in On-X with 19% constant currency growth and tissue processing with 18% constant currency growth," said Pat Mackin, Chairman, President, and Chief Executive Officer. Mr. Mackin added, "In addition to our strong commercial results, we also completed enrollment for our PERSEVERE clinical trial which met every primary endpoint and has set the stage for success with AMDS. Trial data out to 30 days demonstrated a 72% reduction in all-cause mortality and a 52% reduction in the primary composite endpoint of major adverse events, with zero occurrence of distal anastomotic new entry, or DANE, when compared to the current standard of care hemiarch procedure. We continue to work with the FDA toward PMA approval, which we anticipate in the second half of 2025." Mr. Mackin concluded, "Given our solid financial performance, improved capital structure, ongoing clinical progress and operational achievements in 2023, we enter 2024 with strong momentum and confidence in our ability to deliver profitable growth." Fourth Quarter 2023 Financial Results Total revenues for the fourth quarter of 2023 were $93.7 million, an increase of 18% on a GAAP basis and 15% on a non-GAAP constant currency basis, both compared to the fourth quarter of 2022. Net loss for the fourth quarter of 2023 was ($4.0) million, or ($0.10) per fully diluted common share, compared to net income of $2.2 million, or $0.05 per fully diluted common share for the fourth quarter of 2022. Non-GAAP net income for the fourth quarter of 2023 was $4.6 million, or $0.11 per fully diluted common share, compared to non-GAAP net income of $4.2 million, or $0.10 per fully diluted common share for the fourth quarter of 2022. Non-GAAP net income for the fourth quarter of 2023 includes pretax gains related to foreign currency revaluation of $2.2 million. Full Year 2023 Financial Results Total revenues for 2023 were $354.0 million, reflecting an increase of 13% on a GAAP basis and 12% on a non-GAAP constant currency basis compared to the full year of 2022. Net loss for 2023 was ($30.7) million, or ($0.75) per fully diluted common share, compared to net loss of ($19.2) million, or ($0.48) per fully diluted common share for the full year of 2022. Non-GAAP net income for the full year of 2023 was $8.4 million, or $0.20 per fully diluted common share, compared to non-GAAP net income of $2.1 million, or $0.05 per fully diluted common share for the full year of 2022. Non-GAAP net income for the full year of 2023 includes pretax gains related to foreign currency revaluation of $2.1 million. 2024 Financial Outlook The Company expects revenues for the full year 2024 to be in the range of $382 to $396 million, representing growth of 8% to 12% compared to 2023 on both an as reported and constant currency basis. At current exchange rates, the company expects negligible year-over-year currency impact to revenue. Artivion expects non-GAAP adjusted EBITDA, to increase between 26% and 34% for the full year 2024 compared to 2023, resulting in non-GAAP adjusted EBITDA to be in the range of $68 to $72 million in 2024. The Company's financial performance for 2024 and future periods is subject to the risks identified below. Non-GAAP Financial Measures This press release contains non-GAAP financial measures, including non-GAAP revenue, non-GAAP net income, non-GAAP adjusted EBITDA, non-GAAP general, administrative, and marketing expenses, and free cash flows. Investors should consider this non-GAAP information in addition to, and not as a substitute for, financial measures prepared in accordance with US GAAP. In addition, this non-GAAP financial information may not be the same as similar measures presented by other companies. The Company's non-GAAP revenues are adjusted for the impact of changes in currency exchange. The Company's non-GAAP net income; non-GAAP adjusted EBITDA; non-GAAP general, administrative, and marketing, and free cash flows results exclude (as applicable) depreciation and amortization expense; interest income and expense; stock-based compensation expense; loss or gain on foreign currency revaluation; income tax expense or benefit; corporate rebranding expense; business development, integration, and severance income or expense; non-cash interest expense; gain from sale of non-financial assets, and abandonment of CardioGenesis cardiac laser therapy business. The Company generally uses non-GAAP financial measures to facilitate management's review of the operational performance of the company and as a basis for strategic planning. Company management believes that these non-GAAP presentations provide useful information to investors regarding unusual non-operating transactions; the operating expense structure of the Company's existing and recently acquired operations, without regard to its on-going efforts to acquire additional complementary products and businesses, and the transaction and integration expenses incurred in connection with recently acquired and divested product lines; and the operating expense structure excluding fluctuations resulting from foreign currency revaluation and stock-based compensation expense. The Company believes it is useful to exclude certain expenses because such amounts in any specific period may not directly correlate to the underlying performance of its business operations or can vary significantly between periods as a result of factors such as impact of recent acquisitions, non-cash expense related to amortization of previously acquired tangible and intangible assets, and any related adjustments to their carrying values. The Company has adjusted for the impact of changes in currency exchange from certain revenues to evaluate comparable product growth rates on a constant currency basis. The Company does, however, expect to incur similar types of expenses and currency exchange impacts in the future, and this non-GAAP financial information should not be viewed as a statement or indication that these types of expenses will not recur. Company management encourages investors to review the Company's consolidated financial statements and publicly filed reports in their entirety, including the reconciliation of GAAP to non-GAAP financial measures. Webcast and Conference Call Information The company will hold a teleconference call and live webcast on February 15, 2024, at 4:30 p.m. ET to discuss the results, followed by a question and answer session. To participate in the conference call dial 201-689-8261 a few minutes prior to 4:30 p.m. ET. The teleconference replay will be available approximately one hour following the completion of the event and can be accessed by calling (toll free) 877-660-6853 or 201-612-7415. The conference number for the replay is 13742847. The live webcast and replay can be accessed by going to the Investors section of the Artivion website at and selecting the heading Webcasts & Presentations. About Artivion, Inc. Headquartered in suburban Atlanta, Georgia, Artivion, Inc. is a medical device company focused on developing simple, elegant solutions that address cardiac and vascular surgeons' most difficult challenges in treating patients with aortic diseases. Artivion's four major groups of products include: aortic stent grafts, surgical sealants, On-X mechanical heart valves, and implantable cardiac and vascular human tissues. Artivion markets and sells products in more than 100 countries worldwide. For additional information about Artivion, visit our website, . Forward Looking-Statements Statements made in this press release that look forward in time or that express management's beliefs, expectations, or hopes are forward-looking statements within the meaning of the Private Securities Litigation Reform Act of 1995. Such forward-looking statements reflect the views of management at the time such statements are made. These statements include, but are not limited to, that we are entering 2024 with strong momentum and confidence in our ability to drive profitable growth, given our financial performance in 2023, our improved capital structure, and our on-going clinical progress; we expect revenues for the full year 2024 to be in the range of $382 to $396 million, representing revenue growth of between 8% to 12% compared to 2023, both as reported and on a constant currency basis; expect, at current exchange rates, negligible impact year-over-year to revenue on a constant currency basis; and expect non-GAAP adjusted EBITDA, to increase between 26% and 34% for the full year 2024 compared to 2023, resulting in non-GAAP adjusted EBITDA in the range of $68 to $72 million in 2024. These forward-looking statements are subject to a number of risks, uncertainties, estimates and assumptions that may cause actual results to differ materially from current expectations, including but not limited to the benefits anticipated from the Ascyrus Medical LLC transaction and Endospan agreements and our operational improvements in our tissue business may not be achieved at all or at the levels we anticipate or had originally anticipated; and the benefits anticipated from our clinical trials and regulatory approvals not be achieved or achieved on our anticipated timelines. These risks and uncertainties include the risk factors detailed in our Securities and Exchange Commission filings, including our Form 10-K for the year ended December 31, 2023 and subsequent Quarterly Reports on Form 10-Q and annual reports on Form 10-K. Artivion does not undertake to update its forward-looking statements, whether as a result of new information, future events, or otherwise. SOURCE Artivion