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 Alphamab reported 2024 Interim Results and Business Highlights (Press release, Alphamab, AUG 16, 2024, View Source [SID1234647172]).

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On August 16, 2024 Nuntius Therapeutics reported a strategic collaboration agreement with Japan’s Taiho Pharmaceutical to develop next-generation messenger ribonucleic acid (mRNA) cancer immunotherapies (Press release, Nuntius Therapeutics, AUG 16, 2024, View Source [SID1234646069]).

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The partnership will leverage Nuntius’ nanocarrier technologies, which have shown potential in targeting cell types beyond the liver, a significant advancement in mRNA delivery.

This collaboration follows a successful feasibility study that demonstrated the capabilities of Nuntius’ cell-specific peptide dendrimer- and lipid-based nanocarriers.

Nuntius Therapeutics CEO and co-founder Benita Nagel said: "We are thrilled to embark on this collaboration with Taiho to improve treatments for cancer patients. Taiho is an excellent partner for us given their strong oncology-focused research and commercial capabilities."

The company’s programmable and scalable nanocarriers may work on cell types other than the liver and surpass current delivery technologies.

On August 16, 2024 AIM ImmunoTech Inc. (NYSE American: AIM) ("AIM" or the "Company") reported its financial results for the second quarter 2024 (Press release, AIM ImmunoTech, AUG 16, 2024, View Source [SID1234645959]). As previously announced, the Company will host a conference call and webcast today, Friday, August 16, 2024, at 8:30 AM ET (details below).

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"We continue to see great potential in Ampligen as we progress across our clinical development programs and look forward to results from our ongoing studies in the near future. Our entire team remains dedicated to patients and stockholders and will continue to drive momentum across our operational, clinical and regulatory initiatives throughout the remainder of 2024. We strongly believe in the potential of Ampligen to have a meaningful therapeutic benefit across multiple indications as well as the opportunity to unlock significant shareholder value," commented AIM Chief Executive Officer, Thomas K. Equels.

Recent Highlights

Announced new positive data on Ampligen’s anti-tumor potential when used as part of a combination therapy for the treatment of melanoma
A manuscript of the results titled, "Therapeutic Anti-Tumor Efficacy of DC-Based Vaccines Targeting TME-Associated Antigens is Improved When Combined with a Chemokine-Modulating Regimen and/or Anti-PD-L1" was published in the peer-reviewed journal Vaccines.
Released several CEO Corner segments highlighting Company news and programs
Summary of Financial Highlights for Second Quarter 2024

As of June 30, 2024, AIM reported cash, cash equivalents and marketable securities of $10.1 million.
Research and development expenses for the three months ended June 30, 2024, were $1.1 million, compared to $3.0 million for the same period in 2023. Expenses for the six months ended June 30, 2024, were $3.1 million, compared to $5.0 million for the same period in 2023.
General and administrative expenses were $2.6 million for the three months ended June 30, 2024, compared to $2.6 million for the same period 2023. Expenses were $6.4 million for the six months ended June 30, 2024, compared to $4.8 million for the same period in 2023.
The net loss from operations for the three months ended June 30, 2024, was $1.8 million, or $0.03 per share, compared to $4.9 million, or $0.10 per share, for the same period in 2023. Net loss for the six months ended June 30, 2024, was $7.7 million, or $0.15 per share, compared to $8.6 million, or $0.18 per share, for the same period in 2023.
Please refer to the full 10-Q for complete details.

Conference Call and Webcast Details

As previously announced, the Company will host a conference call and webcast to discuss the Company’s Q2 2024 operational and financial results today, August 16, 2024 at 8:30 AM ET.

The call will be hosted by members of AIM’s leadership team, Thomas K. Equels, Chief Executive Officer and Christopher McAleer, PhD, Scientific Officer. Interested participants and investors may access the conference call by dialing (877) 407-9219 (domestic) or (201) 689-8852 (international) and referencing the AIM ImmunoTech Conference Call. The webcast will be accessible on the Events page of the Investors section of the Company’s website, aimimmuno.com, and will be archived for 90 days following the live event.

On August 16, 2024 Iovance Biotherapeutics, Inc. (NASDAQ: IOVA) ("Iovance" or the "Company"), a biotechnology company focused on innovating, developing, and delivering novel polyclonal tumor infiltrating lymphocyte ("TIL") therapies for patients with cancer, reported that on August 15, 2024 (the "Date of Grant"), the Company approved the grant of inducement stock options and restricted stock units covering an aggregate of 289,710 shares of Iovance’s common stock to twenty-four new, non-executive employees (Press release, Iovance Biotherapeutics, AUG 16, 2024, View Source [SID1234645960]).

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The awards were granted under Iovance’s 2021 Inducement Plan, which was adopted on September 22, 2021 and amended on January 12, 2022, March 13, 2023, and February 26, 2024 and provides for the granting of equity awards to new employees of Iovance by the Company’s compensation committee in accordance with Nasdaq Listing Rule 5635(c)(4). Each of the stock options granted as referenced in this press release has an exercise price of $10.67, the closing price of Iovance’s common stock on the Date of Grant. Each stock option and restricted stock unit vests over a three-year period, with one-third of the shares vesting on the first anniversary of the employee’s start date (the "First Vesting Date"), and the remaining shares vesting in eight quarterly installments over the next two years, commencing with the first quarter following the First Vesting Date, subject to continued employment with the Company through the applicable vesting dates.