Monday, June 01, 2020 10:13:28 AM
Highlights from the Quarter and Recent Weeks
-- Announced that the Accordion Pill (AP) developed for a Merck & Co. (MSD) proprietary compound met the in vitro specifications set forth in the companies' research collaboration and the Company is now in discussions with MSD regarding advancing the program into the clinic;
-- Enhanced the balance sheet with a $6.5 million public offering in February 2020 and with a $5 million registered direct offering in May 2020;
-- Received a $1.5 million payment from Novartis related to the conclusion of the Feasibility Option Agreement the Company had with Novartis;
-- Initiated AP-Carbidopa/Levodopa (AP CD/LD) commercial manufacturing stability lots with LTS Lohmann Therapie-Systeme AG (LTS);
-- Completed the redesign of AP-Tetrahydrocannabinol (AP-THC) and are awaiting delivery of synthetic THC to initiate clinical material production; and
-- Initiated next generation AP technologies to include longer retention times (e.g. 24 hour gastric retention) as well as larger molecules (e.g. peptides).
Management Commentary
"We continue to build the company's scientific and technical expertise in oral drug delivery and drug-on-film technologies. Our research and manufacturing teams continue to drive innovation as we expand our capabilities and build out our portfolio of potential applications," stated Jeffrey A. Meckler, Vice Chairman and Chief Executive Officer of Intec Pharma.
"In collaboration with our partner, LTS, we demonstrated our ability to manufacture at commercial scale. This proficiency, coupled with our recent successes in developing unique APs to meet the technical specifications set forth by Novartis and Merck, enhances our ability to engage in partnership discussions with other large biopharma companies as we actively seek to add more collaborative agreements in 2020.
"""""Our partnering activities for the AP-CD/LD program in Parkinson's disease continue and there remain multiple parties with interest in this program. Unfortunately, this has not progressed to an agreement and believe this is related to certain commercialization concerns as well as to the overall market environment as a result of the COVID-19 pandemic. In addition, we continue our discussions with Merck with an aim to advance that program into human pharmacokinetic (PK) trials.""""
"We are delighted to report the completion of a new AP design for our AP-THC program that we expect will meet our stringent PK specifications. We are currently awaiting receipt of the active pharmaceutical ingredients so we can initiate clinical material production and, hopefully, advance this program into the clinic later this year.
Recent INDP News
- Form 8-K - Current report • Edgar (US Regulatory) • 08/08/2024 12:00:34 PM
- Form 424B5 - Prospectus [Rule 424(b)(5)] • Edgar (US Regulatory) • 08/07/2024 09:28:25 PM
- Indaptus Therapeutics, Inc. Announces $3.0 Million Registered Direct Offering and Concurrent Private Placement • GlobeNewswire Inc. • 08/07/2024 11:00:00 AM
- Form 424B5 - Prospectus [Rule 424(b)(5)] • Edgar (US Regulatory) • 08/06/2024 09:23:56 PM
- Indaptus Therapeutics to Present Positive Data on Lead Product Candidate, Decoy20, at STING & TLR-Targeted Therapies Summit • GlobeNewswire Inc. • 06/11/2024 12:00:00 PM
- Form 4 - Statement of changes in beneficial ownership of securities • Edgar (US Regulatory) • 06/07/2024 09:00:16 PM
- Form 8-K - Current report • Edgar (US Regulatory) • 06/07/2024 08:30:38 PM
- Indaptus Therapeutics to Present New Positive Data on Decoy20 at Next-Gen Immuno-Oncology Conference • GlobeNewswire Inc. • 06/04/2024 12:00:00 PM
- Indaptus Therapeutics Announces New Positive Data from Ongoing Phase 1 Trial of Decoy20 • GlobeNewswire Inc. • 06/03/2024 12:00:00 PM
- Indaptus Therapeutics to Present at the Jefferies Global Healthcare Conference • GlobeNewswire Inc. • 05/30/2024 12:00:00 PM
- Indaptus Therapeutics to Present New Cohort Data Confirming Original “Pulse-Prime” Hypothesis Via Phase 1 Clinical Trial of Decoy20 at the American Society of Clinical Oncology Annual Meeting • GlobeNewswire Inc. • 05/29/2024 12:00:00 PM
- Form 8-K - Current report • Edgar (US Regulatory) • 05/22/2024 12:00:18 PM
- Indaptus Therapeutics Announces Completion of First Patient to Receive Multiple Doses of Decoy20, the Company’s Broad-Based, “Pulse-Prime” Immuno-Oncology Therapy for Advanced Solid Tumors • GlobeNewswire Inc. • 05/22/2024 12:00:00 PM
- Form 10-Q - Quarterly report [Sections 13 or 15(d)] • Edgar (US Regulatory) • 05/08/2024 12:06:38 PM
- Form 8-K - Current report • Edgar (US Regulatory) • 05/08/2024 12:05:19 PM
- Indaptus Therapeutics Reports First Quarter 2024 Financial Results and Provides Corporate Update • GlobeNewswire Inc. • 05/08/2024 12:00:00 PM
- Indaptus Therapeutics Presents Positive Mechanism of Action Data at the American Association for Cancer Research Annual Meeting • GlobeNewswire Inc. • 04/11/2024 11:30:00 AM
- Indaptus Therapeutics to Present at the MedInvest Biotech and Pharma Investor Conference • GlobeNewswire Inc. • 03/28/2024 12:00:00 PM
- Indaptus Therapeutics Previews Positive Mechanism of Action Data to be Presented at the American Association for Cancer Research Annual Meeting • GlobeNewswire Inc. • 03/25/2024 12:30:00 PM
- Indaptus Therapeutics to Participate in Tribe Public Webinar On Wednesday, March 20, 2024 • GlobeNewswire Inc. • 03/18/2024 12:00:00 PM
- Indaptus Therapeutics Reports Fourth Quarter and Year-End 2023 Financial Results and Provides Corporate Update • GlobeNewswire Inc. • 03/13/2024 11:30:00 AM
- Form 8-K - Current report • Edgar (US Regulatory) • 03/04/2024 04:01:33 PM
- Indaptus Therapeutics Announces Positive Results from Second Cohort of Phase 1 Trial; Company Initiates Multi-Dose Cohort • GlobeNewswire Inc. • 03/04/2024 12:30:00 PM
- Indaptus Therapeutics to Present at the 2024 BIO CEO & Investor Conference • GlobeNewswire Inc. • 02/15/2024 01:00:00 PM
- Indaptus Therapeutics Expands Digital Presence with Launch of Social Media Channels • GlobeNewswire Inc. • 02/08/2024 01:00:00 PM
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