Forward-Looking Statements
This Quarterly Report on Form 10-Q includes forward-looking statements within
the meaning of the Private Securities Litigation Reform Act of 1995 that reflect
management's current views with respect to future events and financial
performance including meeting our obligations under the Melior I and Melior II
license agreements and our liquidity. The following discussion should be read in
conjunction with the financial statements and related notes and the Risk Factors
contained in our Annual Report on Form 10-K, for the year ended
Forward-looking statements are inherently subject to risks and uncertainties, many of which we cannot predict with accuracy and some of which we might not even anticipate. Although we believe that the expectations reflected in such forward-looking statements are based upon reasonable assumptions at the time made, we can give no assurance that such expectations will be achieved. Future events and actual results, financial and otherwise, may differ materially from the results discussed in the forward-looking statements. Readers are cautioned not to place undue reliance on these forward-looking statements. We undertake no obligation to publicly update or revise any forward-looking statements after the date of this Quarterly Report on Form 10-Q or to conform them to actual results, new information, future events or otherwise, except as otherwise required by securities and other applicable laws.
The following factors, among others, could cause our or our industry's future results to differ materially from historical results or those anticipated:
? our ability to obtain additional funding for our company, whether pursuant to a capital raising transaction arising from the sale of our securities, a strategic transaction or otherwise; ? our ability to satisfy our disclosure obligations under the Securities Exchange Act of 1934, as amended, and to maintain the registration of our common stock thereunder; ? our ability to attract and retain qualified officers, directors, employees and consultants as necessary; ? Challenges or inability to comply with or obtain waivers or extensions under our license agreements, in which case we may be forced to suspend or terminate certain of our research and development programs; ? the cost of our research and development programs may be higher than expected, and there is no assurance that such efforts will be successful in a timely manner or at all; and ? Failure to meet our obligations under outstanding financing documents.
These statements are only predictions and involve known and unknown risks, uncertainties and other factors, including the risks in the section entitled "Risk Factors" set forth in our Annual Report on Form 10-K, any of which may cause our company's or our industry's actual results, levels of activity, performance or achievements to be materially different from any future results, levels of activity, performance or achievements expressed or implied by these forward-looking statements. These risks may cause our or our industry's actual results, levels of activity or performance to be materially different from any future results, levels of activity or performance expressed or implied by these forward-looking statements.
Although we believe that the expectations reflected in the forward-looking statements are reasonable, we cannot guarantee future results, levels of activity or performance. Moreover, neither we nor any other person assumes responsibility for the accuracy and completeness of these forward-looking statements. We are under no duty to update any forward-looking statements after the date of this report to conform these statements to actual results.
35
As used in this quarterly report and unless otherwise indicated, the terms "we,"
"us," "our" or the "Company" refer to
Corporate Overview
Nature of Business
We are an emerging specialty biotech company that, to the extent that resources and opportunities become available, is strategically evaluating its focus including a return to a drug discovery and development company.
On
On
On
On
To the extent that resources have been available, we have continued to work with our advisors in an effort to restructure our Company and to identify potential strategic transactions, including the Melior transaction described above to enhance the value of the Company. Because of our substantial unpaid debt, if we do not raise substantial additional capital in the near future, it is likely that the Company will discontinue all operations or seek bankruptcy protection.
36 Results of Operations
Comparison of the Three Months Ended
Operating Expenses
Our operating expenses for the three months endedJune 30, 2022 , and 2021 are summarized as follows: Three Months Ended June 30, June 30, Increase/ (in thousands) 2022 2021 (Decrease) Sales and marketing $ -$ 8 $ (8 ) General and administrative expenses 449 121 328 Total operating expenses$ 449 $ 129 $ 320 Sales and Marketing
Sales and marketing expenses for the three months ended
General and Administrative
General and administrative expense increased by approximately$328,000 for the three months endedJune 30, 2022 , as compared to the three months endedJune 30, 2021 . The increase was primarily due to an increase in public company fees including legal expenses, audit fees and fees paid for director and officer insurance. Other Expense Three Months Ended June 30, June 30, Increase/ (in thousands) 2022 2021 (Decrease) Interest expense$ (361 ) $ (248 ) $ 113 Gain on extinguishment of debt 210 - (210 ) Initial and change in derivative liability 1,012 (87 ) (1,099 ) Amortization of debt discount (313 ) (50 ) 263 Total other income (expense)$ 548 $ (385 ) $ 933
Interest expense for the three months ended
Comparison of the Six Months Ended
Operating Expenses
Our operating expenses for the six months endedJune 30, 2022 , and 2021 are summarized as follows: Six Months Ended June 30, June 30, Increase/ (in thousands) 2022 2021 (Decrease) Sales and marketing $ -$ 17 $ (17 ) General and administrative expenses 709 222 487 Total operating expenses$ 709 $ 239 $ 470 Sales and Marketing
Sales and marketing expenses for the six months ended
General and Administrative
General and administrative expense increased by approximately$487,000 for the six months endedJune 30, 2022 , as compared to the six months endedJune 30, 2021 . The increase was primarily due to an increase in public company fees including legal expenses, audit fees and fees paid for director and officer insurance. Other Expense Six Months Ended June 30, June 30, Increase/ (in thousands) 2022 2021 (Decrease) Interest expense$ (672 ) $ (491 ) $ 181 Gain on extinguishment of debt 215 - (215 ) Initial and change in derivative liability 1,679 (87 ) (1,766 ) Amortization of debt discount (488 ) (125 ) 363 Total other income (expense)$ 734 $ (703 ) $ 1,437
Interest expense for the six months ended
Liquidity & Capital Resources
Working Capital June 30, December 31, (in thousands) 2022 2021 Current assets$ 976 $ 196
Current liabilities (20,971 ) (25,302 )
Working capital deficit
Negative working capital as of
37 Cash Flows and Liquidity
Net cash used in Operating Activities
Net cash used in operating activities was approximately
Net cash used in operating activities was approximately
Net cash used in Investing Activities
There was no cash used in or provided by investing activities for the six months
ended
Net cash provided by Financing Activities
Net cash provided by financing activities for the six months ended
While we recently raised
Financing
In
We do not have sufficient funds to meet our working capital needs for the next 12 months. We will require additional funds in the near future to continue our business. Historically, we have raised additional capital to supplement our commercialization, clinical development and operational expenses. We will need to raise additional funds required, which may result in further dilution in the equity ownership of our shares. There can be no assurance that additional financing will be available or, if available, that it can be obtained on commercially reasonable terms. Failure to raise additional capital through one or more financings, divesting development assets or reducing discretionary spending could have a material adverse effect on our ability to achieve our intended business objectives. These factors raise substantial doubt about our ability to continue as a going concern.
Off-Balance Sheet Arrangements
As of
Critical Accounting Policies and Estimates
Our significant accounting policies are more fully described in the notes to our
consolidated financial statements included herein for the period ended
38
New and Recently Adopted Accounting Pronouncements
Any new and recently adopted accounting pronouncements are more fully described
in Note 1 to our consolidated financial statements included herein for the
period ended
© Edgar Online, source