On August 16, 2024 Agendia, Inc. reported that it has obtained certification from the European Union (EU) In Vitro Diagnostic Medical Device Regulation (IVDR) for three products, including its MammaPrint FFPE Microarray, BluePrint FFPE Microarray, and MammaPrint and BluePrint NGS Kit (Press release, Agendia, AUG 16, 2024, View Source [SID1234645968]). These products are classified as Class C under this regulation. This certification recognizes Agendia’s strict adherence to rigorous quality and safety standards and ensures the tests’ reliability and effectiveness in clinical settings across the EU.

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"We are very proud to receive the IVDR certification for our MammaPrint and BluePrint tests and look forward to continuing our efforts in providing accurate and effective test results to those undergoing breast cancer treatment," said Mark R. Straley, Chief Executive Officer of Agendia. "This achievement not only underscores our commitment to delivering the highest standard of care to patients, but also highlights our ability to meet the stringent regulatory requirements necessary to address the needs of breast cancer patients and clinicians around the world."

The IVDR certification marks a significant advancement in Agendia’s efforts to enhance the decision- making around treatment pathways for those with early breast cancer. For more information about the MammaPrint and BluePrint tests and Agendia’s ongoing clinical trials, please visit: www.agendia.com

On August 16, 2024 Boston Immune Technologies and Therapeutics, Inc. (BITT), a clinical stage developer of novel tumor necrosis factor superfamily receptor (TNFSR) antagonist antibodies, reported a sponsored research and exclusivity agreement with the McQuade Center for Strategic Research and Development, LLC (MSRD), a member of the global Otsuka family of pharmaceutical companies (Press release, BITT, AUG 16, 2024, View Source [SID1234645967]). MSRD will finance key non-human primate studies for the pre-clinical development of BITT’s CD40 antagonist in exchange for an exclusive right to negotiate an acquisition, license or collaboration agreement related to the asset. BITT is also announcing that it has also been awarded a $4M National Institute of Health/National Cancer Institute to support the ongoing Phase I clinical trial of BITT’s lead TNFR2 antagonist.

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"Our agreement with Otsuka will provide significant resources in furtherance of our goal of filing an IND related to our CD40 antagonist program in 2025," said Russell LaMontagne, Co-Founder and Chief Executive Officer of BITT. "This is our second NIH/NCI grant to support our TNFR2 oncology program and confirmation of the novelty of our antibody and the potential of TNFR2 as a therapeutic target."

On August 16, 2024 CASI Pharmaceuticals, Inc. (Nasdaq: CASI) ("CASI" or the "Company"), a Cayman incorporated biopharmaceutical company specializing in the development and commercialization of innovative therapeutics and pharmaceutical products, reported business updates and financial results for the three months ended June 30, 2024 (Press release, CASI Pharmaceuticals, AUG 16, 2024, View Source [SID1234645966]).

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"The second quarter of 2024 was a period of significant progress for CASI as we shifted our Company’s strategy to the development of therapeutics for organ transplant rejection and autoimmune disease," said Dr. Wei-Wu He, Chairman and CEO of CASI Pharmaceuticals. "The keystone of our strategic pivot is CID-103, an anti-CD38 antibody that we believe has potential for therapeutic use across multiple areas of unmet need, including antibody-mediated rejection (AMR) and idiopathic thrombocytopenia purpura (ITP). Ultimately, we believe CID-103 has widespread therapeutic use in many immune-mediated diseases. We are structuring our resources according to this expectation and will aim to advance our anti-CD38 programs at a brisk pace."

Dr. He continued: "For both AMR and ITP, we are anticipating clinical study initiation on an efficient timeline. We are pleased that the U.S. FDA recently cleared our Investigational New Drug (IND) application for CID-103 for the treatment of adults with ITP, and we expect to initiate our planned Phase 1 study by year end. We anticipate that we will submit an IND for CID-103 in AMR in the fourth quarter of this year. We are especially pleased to have recently announced a $15 million private placement financing by Venrock Healthcare Capital Partners, Foresite Capital, and Panacea Venture in support of our strategy and its execution."

CASI’s Board of Directors has formed a special committee to evaluate Dr. He’s proposal letter dated June 21, 2024, to acquire the entire business operations of the Company in China, including all license-in, distribution and related rights in Asia (excluding Japan), for an aggregate purchase price of $40.0 million. The offer price includes assumption of up to $20.0 million of the Company’s debt.

Second Quarter 2024 Financial Highlights

Total revenue was $4.0 million for the three months ended June 30, 2024, compared to $9.8 million for the three months ended June 30, 2023.

Costs of revenues were $1.9 million for the three months ended June 30, 2024, compared to $4.0 million for the three months ended June 30, 2023. The decrease was in line with the decrease of revenues.

Research and development expenses for the three months ended June 30, 2024, were $1.3 million, compared with $2.6 million for the three months ended June 30, 2023.

General and administrative expenses for the three months ended June 30, 2024, were $5.9 million, compared with $7.7 million for the three months ended June 30, 2023.

Selling and marketing expenses for the three months ended June 30, 2024, were $4.4 million, compared with $4.8 million for the three months ended June 30, 2023.

Net loss for the three months ended June 30, 2024, was $7.0 million, compared with $10.1 million for the three months ended June 30, 2023.

As of June 30, 2024, CASI had cash and cash equivalents of $9.5 million. In July 2024, the Company received gross proceeds of $15 million from a Private Placement.
Further information regarding the Company, including its Quarterly Report for the quarter ended June 30, 2024, can be found at www.casipharmaceuticals.com.

On August 16, 2024 Phanes Therapeutics, Inc. (Phanes), a clinical stage biotech company focused on innovative drug discovery and development in oncology, reported that the U.S. Food and Drug Administration (FDA) has granted orphan drug designation (ODD) to PT217 for the treatment of neuroendocrine carcinoma (NEC) (Press release, Phanes Therapeutics, AUG 16, 2024, View Source [SID1234645965]).

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PT217 is a first-in-class bispecific antibody targeting delta-like ligand 3 (DLL3) and cluster of differentiation 47 (CD47) being developed for patients with NEC. NEC is known to be the most aggressive subgroup of neuroendocrine neoplasms and defined as cancers with poorly differentiated morphology and a high proliferation rate. Most of them have their origin in the lung such as SCLC. Others can develop within the gastrointestinal tract, prostate, and pancreas.

PT217 was granted ODD for the treatment of SCLC by the FDA in 2022 and granted Fast Track designation by the agency in 2024 for the treatment of patients with extensive-stage small cell lung cancer (ES-SCLC) with disease progression following platinum chemotherapy with or without a checkpoint inhibitor. Earlier this year, Phanes entered into a clinical supply agreement with Roche to study PT217 in combination with Roche’s anti-PD-L1 therapy, atezolizumab.

The FDA’s Office of Orphan Products Development grants orphan designation status to drugs and biologics that are intended to treat, diagnose, or prevent rare diseases that affect fewer than 200,000 people in the United States. Orphan drug designation provides certain benefits, including financial incentives to support clinical development and the potential for up to seven years of market exclusivity in the U.S. upon regulatory approval.

On August 16, 2024 Scorpius Holdings, Inc. (NYSE American: SCPX), ("Scorpius", or the "Company"), an integrated contract development and manufacturing organization (CDMO), reported the new pricing of an underwritten public offering of 12,500,000 shares of common stock (or pre-funded warrants ("Pre-Funded Warrants") in lieu thereof) (Press release, Scorpius BioManufacturing, AUG 16, 2024, View Source [SID1234645964]). Each share of common stock (or Pre-Funded Warrant) is being offered at a public offering price of $1.00 per share (inclusive of the Pre-Funded Warrant exercise price). The gross proceeds to the Company from the offering are expected to be approximately $12,500,000, before deducting underwriting discounts and offering expenses. In addition, the Company has granted the underwriters a 45-day option to purchase up to an additional 1,875,000 shares of common stock and/or Pre-Funded Warrants solely to cover over-allotments, if any. As previously announced, the Company had terminated the pricing of its underwritten public offering that it had announced on August 6, 2024. Subsequently, the Company requested, and the NYSE American approved, a financial viability exception to the NYSE American stockholder approval rules that would allow the Company to proceed with the closing of the underwritten public offering upon the terms set forth above.

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The offering is expected to close on August 19, 2024, subject to satisfaction of customary closing conditions and trading of the Company’s common stock on the NYSE American is expected to resume that same day.

The Company intends to use the net proceeds of the offering to fund working capital and for general corporate purposes.

ThinkEquity is acting as sole book-running manager for the offering.

A registration statement on Form S-1 (File No. 333-280887), as amended, including a preliminary prospectus, relating to the securities being offered was filed with the Securities and Exchange Commission ("SEC") and became effective on August 6, 2024. This offering is being made only by means of a prospectus. Copies of the final prospectus, when available, may be obtained from ThinkEquity, 17 State Street, 41st Floor, New York, New York 10004. The final prospectus will be filed with the SEC and will be available on the SEC’s website located at View Source

This press release shall not constitute an offer to sell or a solicitation of an offer to buy, nor shall there be any sale of these securities in any state or jurisdiction in which such an offer, solicitation or sale would be unlawful prior to registration or qualification under the securities laws of any such state or jurisdiction.