On April 21, 2023, HCW Biologics Inc. (the "Company") entered into a secured Development Line of Credit Agreement (the "Agreement") with Prime Capital Ventures, LLC, as lender (the "Lender"), pursuant to which the Lender shall advance loans to the Company in an aggregate principal amount not to exceed $26.25 million (the "Maximum Amount") with a scheduled maturity date of April 20, 2028 (the "Maturity Date") (Filing, HCW Biologics, APR 21, 2023, View Source [SID1234630609]). The note issued pursuant to the Agreement bears interest at a fixed rate of seven (7) percent per annum, due monthly in arrears on the first day of each month, and the outstanding principal on the note shall be due and payable in full on the Maturity Date.

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Under the Agreement, within ten (10) days of receipt of the executed Agreement by each of the Company and the Lender, the Company will be required to wire $5.25 million to Lender to serve as a reserve for the payment of interest under the Agreement. In addition, out of the initial advance, the Company shall pay to the Lender a non-refundable fee in the amount of $1.25 million. The Lender is required to make advances to the Company pursuant to the terms of the Agreement in an amount not to exceed the Maximum Amount. The initial advance from the Lender to the Company is contingent upon the Company’s (1) receipt of all necessary permits and approvals to conduct its business and (2) the compliance with all applicable laws, including zoning and environmental laws.

The Agreement contains customary representations, warranties, affirmative and negative covenants, including financial reporting covenants, events of default and indemnification provisions in favor of the Lender referred to in the Agreement. The covenants include restrictions governing the Company’s ability to amend its certificate of incorporation or bylaws in a manner adverse to the Lender, the Company’s incurrence of liens and indebtedness, the Company’s ability to make investments, and the Company’s entry into certain merger and acquisition transactions or dispositions and other matters, all subject to certain exceptions. In connection with the Agreement, the Lender has been granted a first priority lien and security interest in the Company’s new facility under construction at 3300 Corporate Way, Miramar Florida and various construction project-related bank accounts.

The foregoing description of the Agreement is not intended to be complete and is qualified in its entirety by reference to the Agreement, which is filed as Exhibit 10.1 to this Form 8-K and is incorporated herein by reference.

On April 21, 2023 PharmaEssentia Corporation (TPEx:6446, LuxSE: PHECA, PHECR), a leading fully integrated biopharmaceutical company in Taiwan, reported the closing of its Global Depositary Receipt (GDR) offering of 34,000,000 shares of common stock at US$13.61 per share, generating US$462.7 million (Press release, PharmaEssentia, APR 21, 2023, View Source [SID1234630392]).

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"This marks the largest global health care GDR offering to date in 2023 and reflects confidence in the market opportunity for our approved product and the potential of our pipeline," said Ko-Chung Lin, Ph.D., Founder and Chief Executive Officer, PharmaEssentia.

The 34,000,000 Global Depositary Shares (GDS) represented approximately 10% of total issued and outstanding shares of PharmaEssentia after the offering and were priced at a 5.8% discount to the closing price on the Taipei Exchange (TPEx) of NT$440.5 on April 13, 2023. The GDS were listed on the Luxembourg Stock Exchange (LuxSE) under the ticker symbols PHECA and PHECR.

"PharmaEssentia is pursuing growth in four areas: further penetration of BESREMi (ropeginterferon alfa-2b-njft) in key global markets, including the United States, Japan, South Korea and Europe; geographically expanding BESREMi beyond the countries where it is currently approved; developing additional indications for BESREMi in solid tumors; and advancing a pipeline of new long-acting cytokines, immunotherapy candidates and innovative cell therapies," added Dr. Lin. "This strategy coupled with the company’s strengths in R&D, production, manufacturing, and global commercialization proved attractive to many foreign investors. Demand for PharmaEssentia’s GDS was three times greater than the number of shares offered. The success of our oversubscribed offering will fuel our growth strategy and position us to pursue critical development efforts over the next several years. We believe the strong interest in our offering affirms our strategy and potential."

About BESREMi (ropeginterferon alfa-2b-njft)

BESREMi is an innovative monopegylated, long-acting interferon. With its unique pegylation technology, BESREMi has a long duration of activity in the body and is aimed to be administered once every two weeks (or every four weeks with hematological stability for at least one year), allowing dosing that helps meet the individual needs of patients. BESREMi has orphan drug designation for the treatment of polycythemia vera (PV) in adults in the United States. The product was approved by the European Medicines Agency (EMA) in 2019, in the United States in 2021, and has recently received approval in Japan. The drug candidate was invented by PharmaEssentia and the drug substance is manufactured in the company’s Taichung plant, which was cGMP certified by TFDA in 2017 and by EMA in January 2018. PharmaEssentia retains full global intellectual property rights for the product in all indications. BESREMi was approved with a boxed warning for risk of serious disorders including aggravation of neuropsychiatric, autoimmune, ischemic and infectious disorders.

Please see full Prescribing Information, including Boxed Warning.

On April 21, 2023 Oncoinvent AS, a clinical stage company advancing alpha emitter therapy across a variety of solid cancers, reported the online publication of two articles in the recent special edition of Frontiers in Medicine focused on alpha radioisotopes (Press release, Oncoinvent, APR 21, 2023, View Source [SID1234630391]). The first article, titled "Radiation safety considerations for the use of radium-224-calciumcarbonate-microparticles in patients with peritoneal metastasis," focuses on the effective radiation dose limit for hospital workers, carers, and the public from patients receiving 224Ra-CaCO3-MP. The second, titled "First experience with 224Radium-labeled microparticles (Radspherin) after CRS-HIPEC for peritoneal metastasis in colorectal cancer (a phase 1 study)," supports the favorable safety profile of Radspherin and establishes sustained tolerability in all dose levels for patients treated to date with colorectal cancer.

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"We are excited to share these compelling and important publications in this special edition of Frontiers in Medicine, which continue to demonstrate that all dose levels of Radspherin are well tolerated with no dose limiting toxicities to date," said Jan A. Alfheim, Chief Executive Officer of Oncoinvent. "Additionally, with these publications, we have shown that no precautions related to external exposure should be required for patients treated with 224Ra-CaCO3-MP – a major risk factor to consider in radiopharmaceutical development that has now been significantly reduced. We are highly encouraged by the clinical data we have obtained to date and look forward to leveraging our expertise as a leader within the radiopharmaceutical space and progressing the clinical development of Radspherin."

In the publication titled "Radiation safety considerations for the use of radium-224-calciumcarbonate-microparticles in patients with peritoneal metastasis," six patients with colorectal cancer from the phase 1 trial were injected with 7 MBq of 224Ra-CaCO3-MP. At 3, 24, and 120 hours post injection, the patients underwent measurements with an ionization chamber and a scintillator-based iodide detector as well as whole body gamma camera imaging. Researchers also collected urine and blood samples post injection to estimate activity concentration of 224Ra and 212Pb. It was found that the patients’ median effective whole-body half life of 224Ra-CaCO3-MP ranged from 2.6 to 3.7 days, with a mean value of 3.0 days. Importantly, in the scenarios with exposure at the hospital, sporadic patient contact resulted in a range of 3.9–6.8 μSv per patient, and daily contact resulted in 4.3–31.3 μSv depending on the scenario, suggesting that a single hospital worker can treat around 200-400 patients injected with 224Ra-CaCO3-MP before external exposure is exceeded. Family members and other members of the public were expected to receive well below 0.25 mSv, thereby eliminating the need for restrictions to reduce external exposure. These data demonstrate that, due to low dose rates from the patients and low amount of activity found in blood and urine, no precautions related to external exposure are required when treating patients with Radspherin.

In the publication titled "First experience with 224Radium-labeled microparticles (Radspherin) after CRS-HIPEC for peritoneal metastasis in colorectal cancer (a phase 1 study)," 23 patients were enrolled and administered Radspherin at increasing activity dose levels of 1-2-4-7 over a period of 30 days. A total of 68 grade 2 adverse events were reported for 17 patients during the first 30 days; most were considered related to CRS and/or HIPEC. No DLT was documented at the 7 MBq dose level that was then defined as the recommended dose. Additionally, the biodistribution of Radspherin showed a relatively even peritoneal distribution. These results underscore that all dose levels of Radspherin were well tolerated, and DLT was not reached. Of note, no deaths occurred, and no serious adverse events were considered related to Radspherin. This favorable safety profile in the current study is in line with documentation from other preclinical and clinical studies with other related alpha-emitting compounds administered intraperitoneally.

On April 21, 2023 Oblato, Inc. (the Company), a subsidiary company of HLB Therapeutics in Korea, reported the first enrollment for recurrent high-grade glioma patients in a Phase 1 clinical trial in the USA with an oral formulation of its proprietary compound OKN-007 (Press release, Oblato, APR 21, 2023, View Source [SID1234630390]). This is the first step using oral OKN-007 in glioblastoma clinical trials. Along with the ongoing clinical development of an injectable formulation, this Phase 1 trial is expected to broaden the possibility of a new drug approval for the treatment of glioblastoma, a rare and deadly disease.

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The Company has been developing oral formulation of OKN-007 which have many advantages, including greater convenience for the patients, continuous exposure of drugs to the body, and flexibility in development when expanding indications to other cancer types. A total of four hospitals, including Providence Saint John’s Cancer Institute and Norton Healthcare, are participating in the clinical trial. A dose escalation and pharmacokinetic analysis will be investigated in the trial. The Company will determine the dose of OKN-007 oral formulation to be used in future clinical development by integrating the safety and preliminary efficacy results from this study.

In addition, the Company is also conducting a Phase 2 clinical trial with recurrent glioblastoma multiforme (GBM) patients using a combination therapy of OKN-007 injectable formulation and temozolomide at thirteen institutions, including Henry Ford Health System. Patient enrollment was completed in October, 2022 and some patients are still being treated and follow-up for survival status is continuing.

Regarding the development of OKN-007 as a new anti-cancer drug, Ki Hong Ahn, CEO of the Company, stated, "We have decided to develop an oral formulation in consideration of convenience for the patient, which is an important aspect for future commercialization, and plan to have a strategy to increase the value of the new drug in the market with great unmet needs through diversification of treatment options. Through discussions with the FDA, we have already incorporated their suggestions on the clinical study protocol. Along with investigating the efficacy in existing clinical studies with the OKN injectable formulation, our plan for this Phase 1 clinical trial is to determine the safety of an oral dosage form of OKN-007 and define a dose for further clinical trials, thus allowing multiple options for future development".

On April 21, 2023 EDAP TMS SA (Nasdaq: EDAP) ("the Company"), the global leader in robotic energy-based therapies, reported that the Company will be showcasing its Focal One Robotic High Intensity Focused Ultrasound (HIFU) platform at the upcoming Annual Meeting of the American Urological Association (AUA), the largest gathering of urologists worldwide, which will be held April 28th through May 1st in Chicago, IL (Press release, EDAP TMS, APR 21, 2023, View Source [SID1234630389]).

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The Company will be having its largest presence ever at this year’s AUA meeting. Focal Therapy, and the Focal One HIFU platform will be represented in several topics during both plenary presentations and instructional courses throughout the meeting. Presentations will be given by leading academic urologists describing the key advantages of using HIFU therapy with its ability to meet accepted oncological standards for the management of prostate cancer while preserving sexual function and urinary control for patients. With the growing clinical acceptance of focal therapy in the management of prostate cancer, EDAP will also provide presentations delivered by several key thought leaders throughout the meeting in their booth along with hands-on Focal One simulated cases demonstrations. Additionally, EDAP will be featured in the Hands-on Ultrasound Skills Training AUA Accredited Course with the ExactVu Micro-ultrasound platform under the guidance of expert faculty.

"This year’s AUA meeting will highlight the growing adoption of EDAP’s Focal One HIFU platform in the management of prostate cancer," said Ryan Rhodes, Chief Executive Officer of EDAP USA. "Since last year’s meeting, use of Focal One therapy has continued to expand and is now widely recognized as an important technology for the comprehensive management of prostate cancer alongside other notable therapies. As Focal One use grows, major global medical meetings such as the AUA provide EDAP with a unique opportunity to reach a global physician audience to showcase the benefits of our technology and to further help physicians understand the important role and use of Robotic Focal HIFU from experienced colleague users."

About American Urological Association (AUA) Meeting

The AUA Annual Meeting is the world’s foremost meeting of urologists. It attracts more than 11,000 practicing physicians and healthcare professionals to the largest gathering of urological professionals worldwide. With over 300 technical exhibitors, more than 90 educational courses, and over 2,000 accepted abstracts, it delivers the latest in urologic medicine – providing needed tools to healthcare professionals as they continue to improve patient care. Additional information on the meeting can be found at View Source