Plenty to talk about now this is just a bit of trivia from the IPO
QUESTION
What are milestone shares ?
10.3 Milestone Shares
(a) On the Milestone Shares Completion Date, Cortendo must pay to ATL (in cleared funds) the Milestone Shares Subscription Price.
(b) Subject to receiving the Milestone Shares Subscription Price, ATL must:
(i) issue the Milestone Shares to Cortendo on the Milestone Shares Completion Date;
(ii) enter Cortendo into ATL’s Issuer Sponsored Subregister as the holder of the Milestone Shares on the Milestone Shares Completion Date; and
(iii) subject to clause 10.3(c), within 5 Business Days after the day on which the Milestone Shares are issued, give to ASX a cleansing notice under sections 708A(5) and (6) of the Corporations Act.
(c) if ATL forms the view, acting reasonably, that it is unable to give ASX a cleansing notice under clause 10.3(b)(iii), due to ATL being unable to include excluded information (as defined in section 708A(7) of the Corporations Act) in an ASX cleansing notice, ATL may elect not to give such a notice and must communicate such decision to Cortendo prior to the expiry of the 5 Business Day period referred to in that clause. For the avoidance of doubt, the failure to give such a notice does not affect the validity of the issue of the Milestone Shares, however Cortendo acknowledges that it will be restricted from any on-sale of the Milestone Shares during the Moratorium Period (in addition to the restrictions imposed by clause 10.7.
SO am i reading this correct AS WE ADD VALUE they collect shares AT WHAT COST not happy with the success on their own books they want to dib in our pie aswell by the looks of things
Is this the reason it has been kept in the dark i would think management will have to come forward now and clarify this agreement before more confusion sets in because this is about as clear as mud to me and the last thing we need is more doubt around
I am just not sure i dont mind saying its over my head i will have to ring for peace of mind, if below are the actual milestones then we are a long way of recieving any payment, but dont take this as gospel as i am just not sure below is the link to the Filing
Overview of COR-004 and COR-005—Phase 2 Product Candidates for the Treatment of Acromegaly
We are developing COR-004 and COR-005 for the treatment of acromegaly. We in-licensed COR-004 and acquired COR-005 in 2015 as part of our strategy to build our rare endocrine franchise. Acromegaly is a rare endocrine disorder that most commonly results from a benign tumor of the pituitary gland, leading to excess production of GH and IGF-1. The treatment goal is the normalization of IGF-1, which is the main cause of the detrimental clinical signs and symptoms of acromegaly.
COR-004 is a second-generation antisense oligonucleotide in Phase 2 clinical development for the treatment of acromegaly patients who do not adequately respond to SSAs. COR-004, which was discovered by ISIS Pharmaceuticals, has a novel mechanism of action targeting GHR mRNA, a molecule that is necessary for the synthesis of human growth hormone receptor, or GHR, protein. Antisense oligonucleotides work by binding to mRNA, triggering its destruction by enzymes before it can be translated into the protein. COR-004 binds to GHR mRNA, thereby preventing GHR from being expressed on cell surfaces. Absence of GHR leads to reduced concentrations of circulating IGF-1, which is responsible for the disease signs and symptoms in acromegaly. COR-004 recently completed a Phase 2 clinical trial that showed a statistically significant reduction in IGF-1 levels at the twice per week 200 mg dose, and a safety profile comparable to that of other second-generation antisense drugs in late-stage development for other indications. We intend to seek orphan drug designation for COR-004 from the FDA and the EMA. We plan to initiate nonclinical animal studies during 2015 and plan to have a pre-IND meeting with the FDA in the second half of 2015 before filing an IND for COR-004 in the United States, and IND-equivalent filings in other regulatory jurisdictions. We anticipate that at least one pivotal registration clinical trial with at least six months of controlled treatment will be needed to evaluate efficacy, along with at least six additional months of treatment observation to evaluate safety. However, depending on advice from regulatory authorities, we may be required to complete an additional clinical trial prior to initiating our pivotal program
Completed Clinical Trials
COR-004 has been dosed as subcutaneous injection in 50 subjects in two clinical trials to date, including a Phase 1 safety and pharmacokinetic clinical trial in 36 healthy subjects, 12 of which received placebo, as well as a Phase 2 efficacy clinical trial in 26 patients with acromegaly. In both clinical trials, COR-004 showed a dose-dependent tolerability profile consistent with other antisense oligonucleotides. The Phase 2 clinical trial showed a statistically significant reduction in IGF-1 levels. A second Phase 2 clinical trial with a higher dose of COR-004 is currently being conducted in four patients by Antisense Therapeutics Limited, or Antisense Therapeutics, from whom we in-licensed this product candidate. All studies to date have been conducted outside of the United States. We plan to conduct Phase 3-enabling chronic toxicology studies in two animal species and in parallel to seek a pre-IND meeting with the FDA in the second half of 2015 to discuss requirements for entry into Phase 3 clinical development.
Ongoing Phase 2 Clinical Trial
1103-CT03 Clinical Trial
This clinical trial, 1103-CT03, is a randomized, open-label dose ranging Phase 2 clinical trial to evaluate the efficacy, pharmacokinetics, safety and tolerability of subcutaneous doses of COR-004 in adult patients with acromegaly. This study is being conducted by Antisense Therapeutics. This clinical trial is a 13 week treatment of twice weekly subcutaneous injections of 300 mg of COR-004 in four patients with acromegaly. Patient recruitment is underway. The primary and secondary endpoints are similar to those in Study 1103-CT02.
License Agreements
Our exclusive license agreement with ATL provides us with development and commercialization rights to ATLs' product candidate, ATL1103, for endocrinology applications. We refer to this product candidate as COR-004. Under the terms of the agreement, we paid ATL an initial upfront license fee of $3.0 million in cash, and we also paid $2.0 million for 15,025,075 shares of ATL common stock. On May 13, 2015, the date of the agreement, ATLs common stock had a fair value of $0.095 per share, which was the quoted market price of the ATL common stock on the ASX (Australian Securities Exchange). As ATL is a publicly listed entity and under the terms of the agreement, we may not contractually sell ATL's common shares for 24 months from the date of purchase, we fair valued our investment and determined an estimated discount rate for the lack of marketability of $0.022 per share using an option pricing model that estimated the value of a protective put option using inputs that included quoted market prices and observable inputs other than quoted market prices. We recorded the net amount of the ATL common stock of $1.1 million as a non current asset in our consolidated balance sheet as at June 30, 2015. The difference between the amount paid for the ATL common stock of $2.0 million and the fair value of the ATL common stock on the date of transaction of, $1.1 million, has been recorded as research and development expense as of June 30, 2015, as we determined that the difference constitutes part of the cost of the license.
We may become obligated to make additional payments, contingent upon achieving specific development and commercialization milestones, of up to $105.0 million over the lifetime of the agreement. We may also be required to make royalty payments based on a percentage, ranging from the mid-single digits to the mid-teens, of net sales of COR-004, if approved.
7.8 Performance obligations
(a) Cortendo must:
(i) use, and must cause each Sub-Licensee to use, Commercially Reasonable Efforts to cause each Milestone to be met, and the full amount of each Milestone Fee to be paid, as soon as possible; and
(ii) without limiting its obligations under paragraph (i), but subject to any extension of time due to a Delay as determined pursuant to clauses 7.8(f) — (h):
(A) meet the Toxicology Milestone by the Toxicology Milestone Date; and
(B) meet the In-Human Trial Milestone by the In-Human Trial Milestone Date.
(b) Cortendo must use, and must cause each Sub-Licensee to use, Commercially Reasonable Efforts to:
(i) file for Marketing Approval (excluding Pricing Approval) to sell an ATL1103 Product in each of the US, Canada, the United Kingdom, France, Germany, Italy and Spain within one year of US Approval or EU Approval (whichever occurs first) of that ATL1103 Product; and
(ii) sell ATL1103 Products in each Major Market within one year of obtaining Marketing Approval in that Major Market.
(c) If Cortendo does not comply with an obligation in clause 7.8(b)(i) or 7.8(b)(ii) in respect of a market, but subject to any extension of time due to a Delay as determined pursuant to clauses 7.8(f) — (h), and after compliance with clause 7.8(l), as applicable, ATL may notify Cortendo that the Territory no longer includes the relevant Major Market with effect from the date of the notice (or any later date specified in the notice) and such Major Market will form part of the ATL Territory from the date of that notice.
(d) Cortendo must use, and must cause each Sub-Licensee to use, Commercially Reasonable Efforts to sell any ATL1103 Products in any country (other than a Major Market) where an existing Marketing Approval allows it to sell such ATL1103 Product in that market (due to mutual recognition laws).
26.18 Entire agreement
This agreement (together with all Schedules to this agreement) constitutes the entire agreement between the parties in connection with its subject matter and supersedes all previous agreements or understandings between the parties in connection with its subject matter, including the Non-Disclosure Agreement
1 For the avoidance of doubt, if the In-Human Trial Milestone is a Phase III Trial, then the Milestone Fees in the second column of the above table apply and the third column of the above table no longer has any application or relevance under this agreement.
26.18 Entire agreement
This agreement (together with all Schedules to this agreement) constitutes the entire agreement between the parties in connection with its subject matter and supersedes all previous agreements or understandings between the parties in connection with its subject matter, including the Non-Disclosure Agreement.
66 mce-anchor
Schedule 1- Technology
Column 1
0
[****]
67 mce-anchor
Column 1
0
Schedule 2 — Milestones
1. Clinical and Regulatory Milestones 1
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Column 1
Column 2
Column 3
0
Milestone
Milestone Fee
1
WITH RESPECT TO THE FIRST ACROMEGALY INDICATION
Column 1
Column 2
Column 3
Column 4
Column 5
0
If In-Human Trial Milestone was a Phase III Trial
If In-Human Trial Milestone was a Phase II B Trial
1
Start of the first Phase III Trial for an ATL1103 Product for the first Acromegaly Indication in any jurisdiction in the Territory
US$[****], comprising:
- $US[****] to be paid in accordance with clause 9.6; and - the Milestone Shares Subscription Price to be paid in accordance with clause 10.3
US$[****]
2
Filing of an NDA in the U.S. for an ATL1103 Product for the first Acromegaly Indication
US$[****]
US$[****]
3
Filing of an MAA in the EU:
(a) through the centralized procedure; or (b) in at least 3 of the 5 major markets in the EU comprised of the United Kingdom, France, Germany, Italy or Spain); or (c) the date that is six calendar months after filing in at least 1 of the one of the following countries; the United Kingdom, France, Germany, Italy or Spain, whichever occurs first, for an ATL1103 Product for the first Acromegaly Indication
US$[****]
US$[****]
4
US Approval (excluding Pricing Approval) for an ATL1103 Product for the first Acromegaly Indication
US$[****]
US$[****]
5
EU Approval (excluding Pricing Approval) for an ATL1103 Product for the first Acromegaly Indication
US$[****]
US$[****]
6
Japanese Approval (excluding Pricing Approval) for an ATL1103 Product for the first Acromegaly Indication
US$[****]
US$[****]
1 For the avoidance of doubt, if the In-Human Trial Milestone is a Phase III Trial, then the Milestone Fees in the second column of the above table apply and the third column of the above table no longer has any application or relevance under this agreement.
ANP Price at posting:
8.9¢ Sentiment: Hold Disclosure: Held
