Information taken from recent 10-K VI2OLET BPX0
Post# of 223
Posted On: 05/05/2016 9:41:53 PM
Information taken from recent 10-K
VI2OLET BPX03
In addition to VI2OLET, we are also developing BPX03, a prescription drug version of our molecular iodine tablet for the treatment of moderate to severe, periodic breast pain associated with FBC and cyclic mastalgia.
We are planning to commence our first Phase 3 clinical trial for BPX03 to support FDA and foreign regulatory requirements upon completion of the non- investigational new drug application, or non-IND, study meeting with the FDA, and submission of our IND for BPX03. We expect to complete the non-IND study in calendar 2016, which would allow us to commence a Phase 3 clinical study in calendar 2017.
BPX01
"BPX01 is being developed to combine the most successful oral antibiotic drug for the treatment of moderate-severe acne (minocycline) with a targeted topical antibiotic technology specifically designed to localize the delivery of the drug while minimizing systemic side effects. At the present time, there is no FDA-approved topical solution for this drug".
An IND to initiate the first Phase 2a clinical trial of BPX01 was submitted to the FDA in January 2016, and we received a letter from the FDA in March 2016 stating that the study may proceed. We intend to immediately commence the Phase 2a clinical study. We are also preparing to conduct a bridging safety study using oral minocycline as the comparator and a Phase 2b dose-finding clinical study for BPX01.
BPX02
We are developing BPX02, an injectable utilizing biologic materials for aesthetic dermatology applications. This research stage product candidate is currently under internal development with preclinical testing expected to begin in late calendar year 2016.
Capital Resources
As of January 31, 2016, we had cash and cash equivalents of $4.0 million and working capital of $1.6 million. In June 2015, we completed a public offering of common stock, which generated net proceeds of $7.8 million. We also issued an unsecured convertible note with a principal amount of $0.5 million, which was automatically converted into common stock upon our uplisting to the NYSE MKT. In December 2015 we raised net proceeds of $5.5 million in a private offering of our common stock and, in April 2016, we raised net proceeds of approximately $3.6 million from the issuance of common stock and warrants to purchase common stock in a public offering.
In April 2016, we raised net proceeds of approximately $3.6 million, after expenses of approximately $0.7 million, excluding any proceeds for warrant exercises, from the issuance of 3,600,000 shares of common stock and 1,952,000 warrants to purchase common stock in an equity offering under shelf registration statement.
As of April 1, 2016, there were outstanding 28,817,017 shares of the registrant's common stock, $0.001 par value.
2016 Annual Meeting of Stockholders
"Information required to be provided in response to this item will be presented in our definitive proxy statement for our 2016 Annual Meeting of Stockholders to be held on or about June 15, 2016, which information is incorporated into this report by reference".
VI2OLET BPX03
In addition to VI2OLET, we are also developing BPX03, a prescription drug version of our molecular iodine tablet for the treatment of moderate to severe, periodic breast pain associated with FBC and cyclic mastalgia.
We are planning to commence our first Phase 3 clinical trial for BPX03 to support FDA and foreign regulatory requirements upon completion of the non- investigational new drug application, or non-IND, study meeting with the FDA, and submission of our IND for BPX03. We expect to complete the non-IND study in calendar 2016, which would allow us to commence a Phase 3 clinical study in calendar 2017.
BPX01
"BPX01 is being developed to combine the most successful oral antibiotic drug for the treatment of moderate-severe acne (minocycline) with a targeted topical antibiotic technology specifically designed to localize the delivery of the drug while minimizing systemic side effects. At the present time, there is no FDA-approved topical solution for this drug".
An IND to initiate the first Phase 2a clinical trial of BPX01 was submitted to the FDA in January 2016, and we received a letter from the FDA in March 2016 stating that the study may proceed. We intend to immediately commence the Phase 2a clinical study. We are also preparing to conduct a bridging safety study using oral minocycline as the comparator and a Phase 2b dose-finding clinical study for BPX01.
BPX02
We are developing BPX02, an injectable utilizing biologic materials for aesthetic dermatology applications. This research stage product candidate is currently under internal development with preclinical testing expected to begin in late calendar year 2016.
Capital Resources
As of January 31, 2016, we had cash and cash equivalents of $4.0 million and working capital of $1.6 million. In June 2015, we completed a public offering of common stock, which generated net proceeds of $7.8 million. We also issued an unsecured convertible note with a principal amount of $0.5 million, which was automatically converted into common stock upon our uplisting to the NYSE MKT. In December 2015 we raised net proceeds of $5.5 million in a private offering of our common stock and, in April 2016, we raised net proceeds of approximately $3.6 million from the issuance of common stock and warrants to purchase common stock in a public offering.
In April 2016, we raised net proceeds of approximately $3.6 million, after expenses of approximately $0.7 million, excluding any proceeds for warrant exercises, from the issuance of 3,600,000 shares of common stock and 1,952,000 warrants to purchase common stock in an equity offering under shelf registration statement.
As of April 1, 2016, there were outstanding 28,817,017 shares of the registrant's common stock, $0.001 par value.
2016 Annual Meeting of Stockholders
"Information required to be provided in response to this item will be presented in our definitive proxy statement for our 2016 Annual Meeting of Stockholders to be held on or about June 15, 2016, which information is incorporated into this report by reference".
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