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Tuesday, September 11, 2018 8:54:14 PM
In September 2018, the Company plans to submit a request to FDA for an End-of-Phase 2 meeting.
Bright spot:
The Company signed a non-binding term sheet in August 2018 with a global pharmaceutical company for the licensing/rights to Brilacidin for treating oral mucositis and inflammatory bowel diseases. Initial payments, milestone payments and royalties are being negotiated in accordance with the non-binding term sheet. The pharmaceutical company is now engaged in further due diligence. Management can offer no assurances that the parties will enter into a binding definitive agreement.
We have never reported TERM SHEETS before :)
Here is something interesting:
Accrued Outsourcing Costs
Substantial portions of our preclinical studies and clinical trials are performed by third-party laboratories, medical centers, contract research organizations and other vendors, or collectively "CROs". These CROs generally bill monthly or quarterly for services performed, or bill based upon milestone achievement. For preclinical studies, we accrue expenses based upon estimated percentage of work completed and the contract milestones remaining. For clinical studies, expenses are accrued based upon the number of patients enrolled and the duration of the study. We monitor patient enrollment, the progress of clinical studies and related activities to the extent possible through internal reviews of data reported to us by the CROs, correspondence with the CROs and clinical site visits. Our estimates depend on the timeliness and accuracy of the data provided by the CROs regarding the status of each program and total program spending. We periodically evaluate the estimates to determine if adjustments are necessary or appropriate based on information we receive.
This tells me they should have an idea of what the heck was going on and why the heck would IPIX continue to fund the trial if they did not have good reports all the way through. I have a gut feeling that I said earlier that the results are phenomenal and data integrity was in question and more money was put down to make sure the study data is "ACCURATE" time will tell
Contractual Commitments
The Company has total non-cancelable contractual minimum commitments of approximately $4 million to contract research organizations as of June 30, 2018. Expenses are recognized when services are performed by the contract research organizations.
This appears to show we are 1.6 million short? Maybe we owe the CRO for other stuff? But based on cash of 2.4 and IPIX on the hook for 4 million I'd say this is for Prurisol?
Expenditures on Prurisol were approximately $4.1 million during the year ended June 30, 2018. We expect expenditures on Prurisol to continue in future reporting periods, as we complete analysis of the study. We have entered into multiple non-disclosure agreements with pharmaceutical companies that enable us to continue ongoing discussions regarding potential partnering should the trial results support such a relationship.
In the ordinary course of business, we engage in a continual review of opportunities to license our drug compounds and enter into partnering, joint development or similar arrangements with other companies. We currently, and generally at any time, have such opportunities in various stages of active review, including, for example, entry into indications of interest and term sheets and participation in preliminary discussions and negotiations. Any such transaction could be material to us.
Recent IPIX News
- Form 8-K - Current report • Edgar (US Regulatory) • 02/01/2024 01:30:25 PM
- Form 8-K - Current report • Edgar (US Regulatory) • 12/05/2023 09:25:58 PM
- Form 10-Q - Quarterly report [Sections 13 or 15(d)] • Edgar (US Regulatory) • 11/20/2023 09:05:44 PM
- Form NT 10-Q - Notification of inability to timely file Form 10-Q or 10-QSB • Edgar (US Regulatory) • 11/15/2023 01:00:19 PM
- Form 8-K - Current report • Edgar (US Regulatory) • 10/30/2023 08:15:25 PM
- Form 10-K - Annual report [Section 13 and 15(d), not S-K Item 405] • Edgar (US Regulatory) • 09/28/2023 01:00:08 PM
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