GREENWICH LIFESCIENCES, INC. You should read the following discussion and analysis of our financial condition
and results of operations together with and our financial statements and the
related notes appearing elsewhere in this Quarterly Report on Form 10-Q. In
addition to historical information, this discussion and analysis contains
forward-looking statements that involve risks, uncertainties and assumptions.
Our actual results may differ materially from those discussed below. Factors
that could cause or contribute to such differences include, but are not limited
to, those identified below, and those discussed in the section titled "Risk
Factors" included in this Quarterly Report on Form 10-Q or included in our other
public disclosures or our other periodic reports or other documents or filings
filed with or furnished to the
Overview
We are a biopharmaceutical company that is developing GP2, an immunotherapy
designed to prevent the recurrence of breast cancer following surgery. GP2 is a
9 amino acid transmembrane peptide of the HER2/neu (human epidermal growth
factor receptor 2) 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. In a
completed Phase IIb clinical trial led by
Substantial Unmet Need
Following breast cancer surgery in the adjuvant setting, a HER2/neu 3+ patient receives Herceptin in the first year, with the hope that their breast cancer will not recur, with the odds of recurrence slowly decreasing over the first 5 years after surgery. Herceptin has been shown to reduce recurrence rates from 25% to 12% in the adjuvant setting. In the neoadjuvant setting, a patient receives treatment before surgery and, based on the results of a biopsy at surgery, will receive the same or more potent treatment after surgery. Kadcyla has been shown to reduce recurrence rates from 22% to 11% in the neoadjuvant setting. Accordingly, we believe that GP2 may be used to address the 50% of recurring patients who do not respond to either Herceptin or Kadcyla.
GP2 is administered in combination with the immunoadjuvant GM-CSF in years 2-4, following the first year of treatment with Herceptin, in a series of 11 intradermal injections comprising 6 primary injections over 6 months (1 injection per month) followed by 5 booster injections every 6 months thereafter. Furthermore, we believe that recently approved drugs such as Perjeta and Nerlynx do not fully address this unmet need, even in their most efficacious subpopulations, and that in the initial GP2 indication, approximately 17,000 new patients may be eligible for GP2 treatment per year, which could save approximately 1,500 to 2,000 lives per year.
Statistically Significant Phase IIb Clinical Data in HER2/neu 3+ Over-Expressors
In a randomized, single-blinded, placebo-controlled, multi-center (16 sites led
by
Potent Immune Response
In the Phase IIb clinical trial, GP2 immunotherapy elicited a potent immune response in HLA-A02 patients after they received the 6 primary intradermal injections over the first 6 months. The immune response was measured by a local skin test and immunological assays. Further, booster injections given every 6 months thereafter prolonged the immune response, thereby providing longer term protection.
-13- Well Tolerated Safety Profile
In the Phase IIb and three Phase I clinical trials where 138 patients received GP2 immunotherapy, there were no reported serious adverse events related to GP2 treatment.
Upcoming Phase III Clinical Trial
We are planning to launch a Phase III clinical trial using a similar treatment regime as the Phase IIb clinical trial. The manufacturing plan and the Phase III trial protocol have been reviewed by the FDA and final revisions to the Phase III trial protocol are under way, which may include an interim analysis/adaptive trial design. Furthermore, we have commenced GP2 manufacturing, and we are currently in the process of finalizing our engagement of contract manufacturing organizations and contract research organizations for the Phase III clinical trial.
Financial Summary
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.
Basis of Presentation
The accompanying interim unaudited financial statements are presented in
conformity with accounting principles generally accepted in
Results of Operations For the Three Months Ended
Research and Development Expenses
Research and development expenses decreased by
General and Administrative Expenses
General and administrative expenses increased by
Results of Operations For the Nine Months Ended
Research and Development Expenses
Research and development expenses decreased by
General and Administrative Expenses
General and administrative expenses decreased by
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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. As of
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 its business plan, which may require us to raise additional capital.
Cash Flow Activities for the Nine 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 nine months
ended
Financing Activities
We generated
Off-Balance Sheet Arrangements; Commitments and Contractual Obligations
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 of 2002, as amended and (ii) complying with any requirement
that may be adopted by the
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