Subsequent events | Note 10 – Subsequent events Research Collaboration On September 5, 2019, the Company entered into a research collaboration and master services agreement (the “Agreement”) with Chemveda Life Sciences India Private Limited (“Chemveda”), a contract research and manufacturing services company. The Company and Chemveda have been engaged in a collaborative joint research program since February 2017. Under the Agreement, the Company will continue the collaborative joint research program with Chemveda regarding the synthesis of Uttroside B, isolated from the leaves of Solanum nigrum, and any of its analogues for use in the clinical trials and treatment of Hepatocellular Carcinomas and any other targets and therapeutic areas (the “Program”). The term of the Agreement is for up to two years from execution. Under the Agreement and depending upon reaching certain milestones, the Company have agreed to pay Chemveda total compensation of up to $660,000, $360,000 of which will be payable in cash and $300,000 of which will be payable in stock. To date, the Company have paid Chemveda $210,000 in cash compensation under the Agreement and have made no compensation payments in stock. The Company have also agreed to pay royalties (capped at a total amount) to Chemveda based on net sales of any and all drug product(s) resulting from the collaboration, being developed by us. Subject to the terms of the Agreement, Chemveda shall have the first right of refusal and, if exercised, the exclusive right to manufacture any products developed as a result of the Program for precommercial and commercial production. Securities Purchase Agreements In September 2019, the Company executed securities purchase agreements with various investors to purchase units, each unit consisting of (i) one share of common stock and (ii) one and one half (1.5) warrants to purchase a share of common stock, at $0.86, which is 110% of the closing price of the Company’s common stock as listed on OTCQB on September 18, 2019, raising approximately $208,000 in cash. In October 2019, the Company issued 148,261 units (with each unit consisting of one share of common stock and 1.5 warrants to purchase a share of common stock) to the Company’s legal counsel in exchange for $91,922 of services provided. The Company’s Chief Legal Officer and a Director is the Managing Partner at the law firm where these services were provided. Amendment to 2018 Debentures On September 23, 2019, the Company and holder of the 2018 Debentures entered into an amendment agreement to the securities purchase agreement for the 2018 Debentures, pursuant to which, the conversion price of the 2018 Debentures was reduced to the lower of (i) $1.00, (ii) 93% of the average of the four lowest daily VWAPs during the 10 consecutive trading days immediately preceding the conversion date, provided that as long as we are not in default under the 2018 Debentures, the conversion price may never be less than $0.50, or (iii) a price agreed to by us and the investor. Additionally, the maturity date of the 2018 Debentures was extended to September 21, 2020. On September 23 and October 7, 2019, holders of the 2018 Debentures converted an aggregate of $531,992 of principal and accrued interest outstanding under the revised conversion terms and received an aggregate of 1,163,204 shares of the Company’s common stock. Had the holders converted $531,992 of principal and accrued interest under the previously existing conversion terms, the holders would have received 265,996 shares of the Company’s common stock. The additional 897,208 shares received upon conversion had an aggregate fair value of $589,223. Settlement Agreement As described in Note 6, above, the Company commenced litigation against BNI and parties related to BNI in the Supreme Court of New York, New York County o December 28, 2018. On September 23, 2019, the Company entered into a settlement agreement with BNI and parties related to BNI. Pursuant to the terms of the settlement agreement, the Company settled its dispute with BNI and all parties to the litigation dismissed their claims in exchange for entering into a Second Amendment to the License Agreement (entered into on September 23, 2019) pursuant to which: · BNI agreed to immediately transfer and/or assign to the Company all intellectual property, patents and products that is owned by BNI that is related to Strontium-Chloride 89; · The Company agreed to issue BNI 50,000 shares of its common stock upon the entry into the settlement agreement and 100,000 shares of its common stock upon the approval of the U.S. Food and Drug Administration (“FDA”) approval of BNI’s Prior Approval Supplements filing · The Company agreed to make a cash payment to BNI of $25,000 · The Company agreed to an on-going royalty payment of 3% on all gross profits derived by the Company from the sale of Strontium-Chloride 89 and MetastronTM; and · The Company agreed to assume fees and expenses related to (i) all outstanding CMO fees owed by BNI to IsoTherapeutics relating to Strontium-Chloride 89 (approximately $67,000), (ii) all outstanding fees owed by BNI to the FDA relating to Strontium-Chloride 89 (approximately $208,000) and (iii) related fees for the development and approval of Strontium-Chloride 89 following the date of the settlement agreement. The agreement to (i) make a cash payment of $25,000 to BNI, (ii) pay all outstanding CMO fees owed by BNI to IsoTherapeutics relating to Strontium-Chloride 89 (approximately $67,000), and (iii) issue to BNI 50,000 shares of the Company’s common stock are recognizable subsequent events with an aggregate fair value of approximately $125,000. All other portions of the settlement agreement are not recognizable subsequent events. As of August 31, 2019, the Company had recognized $125,000 in accrued expenses related to this matter. The agreement to assume fees owed by BNI to the FDA relating to Strontium-Chloride 89 is not a recognizable subsequent event as of August 31, 2019, as the fee is contingent as of the settlement agreement date and payment of the fee by the Company is not probable as of the settlement agreement date. Repricing of Existing Warrants On September 24, 2019, the Company reduced the exercise price of 950,000 options and warrants previously issued to Denis Corin for services as a director and for services as an officer to $1.25 per share and reduced the exercise price of 1,250,000 options and warrants previously issued to William Rosenstadt for services as a director and for services as an offer to $1.25 per share. On September 24, 2019, the Company reduced the exercise price of 360,000 options and warrants previously issued to Ari Jatwes for services as a consultant to $1.25 per share and reduced the exercise price of 50,000 warrants previously issued to Rick Panicucci for services as a director to $1.25 per share. Distribution Agreement On October 3, 2019, the Company entered into an exclusive distribution agreement for Strontium-89/Metastron™ with Jubilant Radiopharma for the U.S. market. Jubilant Radiopharma is an industry leading pharmaceutical company specializing in nuclear medicine focused on developing, manufacturing, commercializing and distributing high quality and sustainable diagnostic and therapeutic agents on a global scale. Issuance of Debentures On October 11, 2019, the Company entered into a securities purchase agreement with an accredited investor to place convertible debentures with a maturity date of eighteen months after the issuance thereof in the aggregate principal amount of up to $750,000 (the “Transaction”), provided that in case of an event of default, the debentures may become at the holder’s election immediately due and payable. The initial closing of the Transaction occurred on October 11, 2019 when the Company The holder may convert a debenture in its sole discretion at any time on or prior to maturity at the lower of $1.00 or 93% of the average of the four lowest daily VWAPs during the 10 consecutive trading days immediately preceding the conversion date, provided that as long as we are not in default under the debenture, the conversion price may never be less than $0.50. The holder may not convert any portion of a debenture if such conversion would result in the holder beneficially owning more than 4.99% of our then issued and common stock, provided that such limitation may be waived by the holder with 65 days’ notice. Any time after the six-month anniversary of the issuance of a debenture that the daily VWAP is less than $0.50 for a period of twenty consecutive trading days (the “Triggering Date”) and only for so long as such conditions exist after a Triggering Date as that term is defined in the Transaction documents, the Company shall make monthly payments beginning on the last calendar day of the month when the Triggering Date occurred. Each monthly payment shall be in an amount equal to the sum of (i) the principal amount outstanding as of the Triggering Date divided by the number of such monthly payments until maturity, (ii) a redemption premium of 20% in respect of such principal amount and (iii) accrued and unpaid interest hereunder as of each payment date. The Company may, no more than twice, obtain a thirty-day deferral of a monthly payment due as a result of a Triggering Date through the payment of a deferral fee in the amount equal to 10% of the total amount of such monthly payment. Each deferral payment may be paid by the issuance of such number of shares as is equal to the applicable deferral payment divided by a price per share equal to 93% of the average of the four lowest daily VWAPs during the 10 consecutive Trading Days immediately preceding the due date in respect of such monthly payment being deferred, provided that such shares issued will be immediately freely tradable shares in the hands of the holder. |