New filing (see link on this page):
On April 11, 2016, the Company entered into and consummated an agreement and Plan of Merger, with LAT Acquisition Corp., a Nevada corporation and wholly-owned subsidiary of the Company, and LAT Pharma, LLC, an Illinois limited liability company ("LAT"). Pursuant to the terms of the Merger Agreement, LAT Acquisition merged with and into LAT in a statutory triangular merger with LAT surviving as a wholly-owned subsidiary of the Company.
Prior to the Merger the Company was exclusively developing novel nanotechnology anti-infective drugs to combat multi-drug resistant bacteria. Developing this technology in-house is resource-intensive with respect to time, personnel and capital necessary for scientific discovery. The Company is seeking to license additional needed technology to help advance its research. As such, we are extensively focused on identifying and negotiating licensing rights with universities and inventors for requisite technologies to advance our own nanotechnology platform. These negotiations often are unsuccessful. Thus far they have not led to a license agreement.
As a result of the merger, we acquired two product development programs, "CIP Terlipressin Technology" and a minority stake in novel modified terlipressin compounds being developed by its partner PharmaIN Corp. (Bothell, WA). The Company's LAT Pharma, held a pre-investigational new drug ("pre-IND") meeting with the FDA in early 2016, and received guidance to develop an IND submission. If accepted by the FDA, "CIP Terlipressin Technology" could enter human clinical trials as early as next year (2017).
"CIP Terlipressin Technology" is being developed by the Company with the goal of attacking ascites at the mechanistic source by alleviating the portal hypertension and correcting splanchnic vasodilation, thereby increasing effective blood volume and flow, and causing the body to reduce or stop sending chemical signals to the kidneys to retain excess salt and water.
In 2010 LAT Pharma entered into a license agreement with PharmaIN covering the companies' collaboration to develop the first-ever version of the drug terlipressin for subcutaneous outpatient injection based on PharmaIN's proprietary drug delivery technologies. These compounds have recently demonstrated promise in pre-clinical laboratory models.
LAT Pharma and PharmaIN have exchanged small (low single-digit) ownership rights to each of the company's program, and plan to work together to advance both of them towards eventual product commercialization.
The Company will initially spend most of its efforts and resources on its "CIP Terlipressin Technology". This compound is furthest along in development. We anticipate using our expertise to manage and perform what we believe at this time are the most critical aspects of our product development process which includes completion of pre-clinical studies and planning for the filing of an IND with FDA for advancing to clinical studies.
We are now engaged in organizational activities and sourcing compounds and materials. We have not obtained any funding for our drug development business plan nor do we expect to generate revenues in the near future. We may not be successful in developing our drugs, start selling our products when planned, generate revenues, or become profitable in the future. We have incurred net losses in each fiscal period since inception of our operations.
The Company's activities are subject to significant risks and uncertainties including failure to secure additional funding to properly execute the company's business plan.
We have incurred $162,254 of operating expenses for the nine months ended March 31, 2016. We anticipate incurring other costs associated with equipment purchases and general and administrative expenses, including employee salaries and benefits, legal expenses, and other costs associated with an early stage, publicly-traded company.
The amounts that we actually spend for any specific purpose may vary significantly, and will depend on a number of factors including, but not limited to, the pace of progress of our research and development, market conditions, and our ability to qualify vendors. In addition, we may use a portion of any net proceeds to acquire complementary compounds; however, we do not have plans for any acquisitions at this time. We will have significant discretion in the use of any net proceeds. Investors will be relying on the judgment of our management regarding the application of the proceeds of any sale of our Common Stock.
Requirement for Additional Capital
The Company has engaged in limited research and development activities. We currently do not have sufficient funds to meet our planned drug development for the next twelve (12) months and we may not be able to obtain the necessary financing on terms and conditions acceptable to the Company. Assuming that we are successful in raising additional financing, we plan to incur $2,000,000 in expenses over the next 12 months
The Company had approximately $233,200 of cash on hand at March 31, 2016 and will be unable to proceed with its planned drug development, meet its administrative expense requirements, capital costs, or staffing costs without obtaining additional net financing of approximately $2,500,000 to meet its budget.
The Company has limited experience with pharmaceutical drug development. As such these budget estimates may not be accurate. In addition, the actual work to be performed is not known at this time, other than a broad outline, as is normal with any scientific work. As further work is performed, additional work may become necessary or change in plans or workload may occur. Such changes may have an adverse impact on our estimated budget. Such changes may also have an adverse impact on our projected timeline of drug development.
Management intends to use capital and debt financing, as required, to fund the Company's operations. There can be no assurance that the Company will be able to obtain the additional capital resources necessary to fund its anticipated obligations for the next twelve (12) months.
Capital Resources and Liquidity
As of March 31, 2016, we had approximately $233,200 of cash on hand in our corporate bank account. The Company is considered to be a development stage company and will continue in the development stage until generating revenues from the sales of its products or services. As a result, the report of the independent registered public accounting firm on our financial statements as of June 30, 2015, contains an explanatory paragraph regarding a substantial doubt about our ability to continue as a going concern.
We do not have sufficient funds for the next (12) twelve months and must raise cash to implement our strategy and stay in business. If we are unable to raise additional funds to develop our compounds, we may be required to scale back our development plans by reducing expenditures for employees, consultants, business development, and other envisioned expenditures. This could reduce our ability to develop and implement our business plan. In that event, investors should anticipate that their entire investment may be lost and there may be no ability to profit from this investment.
We cannot assure you that our compounds will be developed, work, or receive regulatory approval; that we will ever earn revenues sufficient to support our operations or that we will ever be profitable. Furthermore, since we have no committed source of financing, we cannot assure you that we will be able to raise money as and when we need it to continue our operations. If we cannot raise funds as and when we need them, we may be required to severely curtail, or even to cease, our operations.
If we are unable to raise additional funds, we will need to do one or more of the following:
If we are unable to raise additional funds, we will need to do one or more of the following:
? delay, scale-back or eliminate some or all of our research and product development programs;
? provide licenses to third parties to develop and commercialize products or technologies that we would
otherwise seek to develop and commercialize ourselves;
? seek strategic alliances or business combinations;
? attempt to sell our company;
? cease operations; or
? declare bankruptcy.
We believe that our existing cash, cash equivalents will not be sufficient to meet our operating and capital requirements until June 30, 2016. Any debt financing secured by us in the future could involve restrictive covenants relating to our capital raising activities and other financial and operational matters, which may make it more difficult for us to obtain additional capital and to pursue business opportunities, including potential acquisitions. We may not be able to secure additional debt or equity financing in a timely manner, or at all, which could require us to scale back our business plan and operations.
The above conditions raise substantial doubt about our ability to continue as a going concern. The financial statements included elsewhere herein were prepared under the assumption that we would continue our operations as a going concern. Our financial statements do not include any adjustments that may result from the outcome of this uncertainty. Without additional funds from debt or equity financing, sales of our intellectual property or technologies, or from a business combination or a similar transaction, we will soon exhaust our resources and will be unable to continue operations. If we cannot continue as a viable entity, our stockholders may lose some or all of their investment in us.
Our management intends to attempt to secure additional required funding primarily through additional equity or debt financings. We may also seek to secure required funding through sales or out-licensing of intellectual property assets, seeking partnerships with other pharmaceutical companies or third parties to co-develop and fund research and development efforts, or similar transactions. However, there can be no assurance that we will be able to obtain required funding. If we are unsuccessful in securing funding from any of these sources, we will defer, reduce or eliminate certain planned expenditures in our research protocols. If we do not have sufficient funds to continue operations, we could be required to seek bankruptcy protection or other alternatives that could result in our stockholders losing some or all of their investment in us.
Emerging Growth Company
We are an "emerging growth company" under the federal securities laws and will be subject to reduced public company reporting requirements.
In addition, Section 107 of the JOBS Act also provides that an "emerging growth company" can take advantage of the extended transition period provided in Section 7(a)(2)(B) of the Securities Act for complying with new or revised accounting standards. In other words, an "emerging growth company" can delay the adoption of certain accounting standards until those standards would otherwise apply to private companies. We are choosing to take advantage of the extended transition period for complying with new or revised accounting standards.
Off-Balance Sheet Arrangements
The Company has no off-balance sheet arrangements that have or are reasonably likely to have a current or future effect or change on the Company's financial condition, revenues or expenses, results of operations, liquidity, capital expenditures or capital resources that are material to investors. The term "off-balance sheet arrangement" generally means any transaction, agreement or other contractual arrangement to which an entity unconsolidated with the Company is a party, under which the Company has (i) any obligation arising under a guarantee contract, derivative instrument or variable interest; or (ii) a retained or contingent interest in assets transferred to such entity or similar arrangement that serves as credit, liquidity or market risk support for such assets.
