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| 8-K - FORM 8-K - PALISADE BIO, INC. | f8k_051520.htm |
Exhibit 99.01
Seneca Biopharma Reports 2020 First Quarter Results
GERMANTOWN, Md., May 15, 2020 -- Seneca Biopharma, Inc. (Nasdaq: SNCA), a biopharmaceutical company focused on developing novel treatments for diseases of high unmet medical need, today reported its financial results for the quarter ended March 31, 2020.
Business Highlights for 2020 to date.
During the First Quarter of 2020, the Company achieved the following business milestones:
| · | Continued progress on the Company’s out-licensing effort to partner NSI-566 and NSI-189 programs, while seeking to in-license or acquire novel therapeutics that could benefit from its development experience. |
| · | Completion of an inducement offering resulting in net proceeds of $6.7 million. |
| · | Appointed of Matthew W. Kalnik, Ph.D. as President and Chief Operating Officer and Dane R. Saglio as Chief Financial Officer. |
| · | Affirmed guidance that data readout from the Company's non-GCP Phase II trial evaluating NSI-566, for the treatment of chronic ischemic stroke, is expected during the second half of 2020. |
| · | Announced that as a result of feedback received from the FDA, Seneca believes that the existing Phase 1 and 2 trial results support moving into a Phase 3 clinical study for ALS. |
| · | Completion of the Company’s stem cell manufacturing facility in Suzhou, China which will be used to manufacture NSI-566 for clinical trials within China. |
Financial Results for the Quarter Ended March 31, 2020
Cash Position and Liquidity: At March 31, 2020, cash was approximately $10 million as compared to approximately $5.1 million at December 31, 2019. The increase in cash is attributed to the January 2020 warrant inducement transaction.
Operating Loss: Operating loss for the quarter ended March 31, 2020 was $2.0 million compared to a loss of $2.5 million for the comparable 2019 period. The decrease in operating loss for 2020 was primarily due to a decrease in R&D expenses as we continue to wind down the clinical programs. This decrease was partially offset by an increase in G&A expenses which reflects an enhanced management structure to support corporate objectives as compared to the same period of 2019.
Net Loss: Net loss for the period ended March 31, 2020 was $7.6 million, or $0.93 per share, compared to a loss of $3.1 million, or $3.42 per share on a post-reverse stock-split basis, for the same period in 2019. The change in net loss was primarily attributed to a non-cash expense of $5.6 million related to the January 2020 warrant inducement transaction.
“With Matt and Dane joining the management team we are focused on executing on the strategy of acquiring new therapeutic products for development while seeking partners for our promising neural stem cell therapeutic NSI-566” commented Dr. Kenneth Carter, Seneca’s Executive Chairman.
| Seneca Biopharma, Inc. | ||||||||
| Unaudited Condensed Consolidated Balance Sheets | ||||||||
| March 31, | December 31, | |||||||
| 2020 | 2019 | |||||||
| ASSETS | ||||||||
| CURRENT ASSETS | ||||||||
| Cash and cash equivalents | $ | 10,030,024 | $ | 5,114,917 | ||||
| Trade and other receivables | 19,014 | 21,064 | ||||||
| Prepaid expenses | 414,683 | 510,900 | ||||||
| Total current assets | 10,463,721 | 5,646,881 | ||||||
| Property and equipment, net | 31,130 | 41,036 | ||||||
| Patents, net | 649,745 | 668,936 | ||||||
| ROU and other assets | 215,953 | 227,036 | ||||||
| Total assets | $ | 11,360,549 | $ | 6,583,889 | ||||
| LIABILITIES AND STOCKHOLDERS' EQUITY | ||||||||
| CURRENT LIABILITIES | ||||||||
| Accounts payable and accrued expenses | $ | 961,026 | $ | 824,406 | ||||
| Accrued bonuses | 98,750 | 135,686 | ||||||
| Short-term note and other current liabilities | 126,450 | 264,665 | ||||||
| Total current liabilities | 1,186,226 | 1,224,757 | ||||||
| Warrant liabilities, at fair value | 59,971 | 84,596 | ||||||
| Lease liability, net of current portion | 136,395 | 148,543 | ||||||
| Total liabilities | 1,382,592 | 1,457,896 | ||||||
| STOCKHOLDERS' EQUITY | ||||||||
| Preferred stock, 7,000,000 shares authorized, $0.01 par value; 200,000 shares issued and outstanding at March 31, 2020 and December 31, 2019, respectively | 2,000 | 2,000 | ||||||
| Common stock, $0.01 par value; 300,000,000 shares authorized, 9,428,011 and 3,866,457 shares issued and outstanding at March 31, 2020 and December 31, 2019, respectively | 94,280 | 38,665 | ||||||
| Additional paid-in capital | 239,439,587 | 227,067,058 | ||||||
| Accumulated other comprehensive loss | (7,148 | ) | (6,186 | ) | ||||
| Accumulated deficit | (229,550,762 | ) | (221,975,544 | ) | ||||
| Total stockholders' equity | 9,977,957 | 5,125,993 | ||||||
| Total liabilities and stockholders' equity | $ | 11,360,549 | $ | 6,583,889 | ||||
| Seneca Biopharma, Inc. | ||||||||
| Unaudited Condensed Consolidated Statements of Operations and Comprehensive Loss | ||||||||
| Three Months Ended March 31, | ||||||||
| 2020 | 2019 | |||||||
| Revenues | $ | 6,020 | $ | 2,500 | ||||
| Operating expenses: | ||||||||
| Research and development expenses | 696,889 | 1,514,463 | ||||||
| General and administrative expenses | 1,299,595 | 944,602 | ||||||
| Total operating expenses | 1,996,484 | 2,459,065 | ||||||
| Operating loss | (1,990,464 | ) | (2,456,565 | ) | ||||
| Other income (expense): | ||||||||
| Interest income | 13,289 | 29,000 | ||||||
| Interest expense | (2,579 | ) | (2,017 | ) | ||||
| Warrant inducement expense | (5,620,089 | ) | - | |||||
| Gain (loss) in fair value of liability classified warrants | 24,625 | (340,115 | ) | |||||
| Other expense | - | (344,295 | ) | |||||
| Total other income (expense) | (5,584,754 | ) | (657,427 | ) | ||||
| Net loss | $ | (7,575,218 | ) | $ | (3,113,992 | ) | ||
| Net loss per share - basic and diluted | $ | (0.93 | ) | $ | (3.42 | ) | ||
| Weighted average common shares outstanding - basic and diluted | 8,139,159 | 910,821 | ||||||
| Comprehensive loss: | ||||||||
| Net loss | $ | (7,575,218 | ) | $ | (3,113,992 | ) | ||
| Foreign currency translation adjustment | (962 | ) | (1,743 | ) | ||||
| Comprehensive loss | $ | (7,576,180 | ) | $ | (3,115,735 | ) | ||
About Seneca Biopharma, Inc.
Seneca Biopharma, Inc., is a clinical-stage biopharmaceutical company developing novel treatments for diseases of high unmet medical need. The Company is in the process of transforming the organization through the acquisition or in-licensing of new science and technologies, to develop with the goal of providing meaningful therapies for patients.
Cautionary Statement Regarding Forward Looking Information:
This news release contains "forward-looking statements" made pursuant to the "safe harbor" provisions of the Private Securities Litigation Reform Act of 1995. Such forward-looking statements relate to future, not past, events and may often be identified by words such as "expect," "anticipate," "intend," "plan," "believe," "seek" or "will." Forward-looking statements by their nature address matters that are, to different degrees, uncertain. Specific risks and uncertainties that could cause our actual results to differ materially from those expressed in our forward-looking statements include risks inherent in the development and commercialization of potential products, uncertainty of clinical trial results or regulatory approvals or clearances, need for future capital, dependence upon collaborators and maintenance of our intellectual property rights. Actual results may differ materially from the results anticipated in these forward-looking statements. Additional information on potential factors that could affect our results and other risks and uncertainties are detailed from time to time in Seneca’s periodic reports, including its Annual Report on Form 10-K for the year ended December 31, 2019, filed with the Securities and Exchange Commission (SEC), and in other reports filed with the SEC. We do not assume any obligation to update any forward-looking statements.
Contact:
Hibiscus
Bioventures
josh@hibiscusbio.com