Forward-Looking Statements
This Quarterly Report on Form 10-Q includes forward-looking statements within the meaning of Section 27A of the Securities Act of 1933, as amended (the "Securities Act") and Section 21E of the Securities Exchange Act of 1934, as amended (the "Exchange Act"). All statements other than statements of historical facts contained in this Quarterly Report, including statements regarding the future financial position, business strategy and plans and objectives of management for future operations, are forward-looking statements. The words "believe," "may," "will," "estimate," "continue," "anticipate," "intend," "should," "plan," "expect," and similar expressions, as they relate to us, are intended to identify forward-looking statements. We have based these forward-looking statements largely on current expectations and projections about future events and financial trends that we believe may affect our financial condition, results of operations, business strategy and financial needs. These forward-looking statements are subject to a number of risks, uncertainties and assumptions.
In addition, our business and financial performance may be affected by the
factors that are discussed under "Risk Factors" in the Annual Report on Form
10-K for the year ended
You should not rely upon forward-looking statements as predictions of future events. We cannot assure you that the events and circumstances reflected in the forward-looking statements will be achieved or occur. Although we believe that the expectations reflected in the forward-looking statements are reasonable, we cannot guarantee future results, levels of activity, performance or achievements.
The following discussion and analysis is qualified in its entirety by, and should be read in conjunction with, the more detailed information set forth in the financial statements and the notes thereto appearing elsewhere in this Quarterly Report on Form 10-Q. This discussion should not be construed to imply that the results discussed herein will necessarily continue into the future, or that any conclusion reached herein will necessarily be indicative of actual operating results in the future. Such discussion represents only the best present assessment of our management.
Overview
We are a clinical-stage biopharmaceutical company focused on the development of
GP2, an immunotherapy to prevent breast cancer recurrences in patients who have
previously undergone surgery. GP2 is a 9 amino acid transmembrane peptide of the
HER2/neu protein, a cell surface receptor protein that is expressed in a variety
of common cancers, including expression in 75% of breast cancers at low (1+),
intermediate (2+), and high (3+ or over-expressor) levels. The combination of
GP2 + GM-CSF is called GLSI-100. In a completed randomized, single-blinded,
placebo-controlled, multi-center Phase IIb clinical trial led by
We have commenced Flamingo-01, a Phase III clinical trial with
To date, we have not generated any revenue and we have incurred net losses. Our
net losses were approximately
Our net losses have resulted from costs incurred in developing the drug in our pipeline, planning and preparing for clinical trials and general and administrative activities associated with our operations. We expect to continue to incur significant expenses and corresponding increased operating losses for the foreseeable future as we continue to develop our pipeline. Our costs may further increase as we conduct clinical trials and seek regulatory approval for and prepare to commercialize our product candidate. We expect to incur significant expenses to continue to build the infrastructure necessary to support our expanded operations, clinical trials, commercialization, including manufacturing, marketing, sales and distribution functions. We will also experience increased costs associated with operating as a public company.
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Results of Operations for the Three Months Ended
Research and Development Expenses
Research and development expenses increased by
General and Administrative Expenses
General and administrative expenses decreased by
Results of Operations for the Six Months Ended
Research and Development Expenses
Research and development expenses increased by
General and Administrative Expenses
General and administrative expenses decreased by
Liquidity and Capital Resources
Since our inception in 2006, we have devoted most of our cash resources to research and development and general and administrative activities. We have not yet achieved commercialization of our product and have a cumulative net loss from our operations. We will continue to incur net losses for the foreseeable future. Our financial statements have been prepared assuming that we will continue as a going concern.
We will require additional capital to meet our long-term operating requirements.
We expect to raise additional capital through the sale of equity and/or debt
securities; however, there is no assurance that we will be successful at raising
additional capital in the future. If our plans are not achieved and/or if
significant unanticipated events occur, we may have to further modify our
business plan, which may require us to raise additional capital. As of
Cash Flow Activities for the Six Months Ended
We incurred net losses of
Operating Activities
Net cash used in operating activities was
Investing Activities
We did not use or generate cash from investing activities during the six months
ended
- 10 - Financing Activities
We used a total of
Contractual Obligations and Commitments
As of
Off-Balance Sheet Arrangements
As of
Critical Accounting Policies and Estimates
Our financial statements are prepared in conformity with
On an ongoing basis, we evaluate our estimates and judgments, including those related to accrued expenses and stock-based compensation. We base our estimates on historical experience and on various other assumptions that we believe to be reasonable under the circumstances, the results of which form the basis for making judgments about the carrying values of assets and liabilities and the reported amounts of expenses that are not readily apparent from other sources. Actual results could differ from those estimates, particularly given the significant social and economic disruptions and uncertainties associated with the ongoing coronavirus pandemic and the COVID-19 control responses.
Recent Accounting Pronouncements
As of
JOBS Act
On
We have chosen to take advantage of the extended transition periods available to emerging growth companies under the JOBS Act for complying with new or revised accounting standards until those standards would otherwise apply to private companies provided under the JOBS Act. As a result, our financial statements may not be comparable to those of companies that comply with public company effective dates for complying with new or revised accounting standards.
Subject to certain conditions set forth in the JOBS Act, as an "emerging growth
company," we intend to rely on certain of these exemptions, including, without
limitation, (i) providing an auditor's attestation report on our system of
internal controls over financial reporting pursuant to Section 404(b) of the
Sarbanes-Oxley Act and (ii) complying with any requirement that may be adopted
by the
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