Attached files
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| 8-K - FORM 8-K - PALISADE BIO, INC. | f8k_111620.htm |
Exhibit 99.01
Seneca Biopharma Reports 2020 Third Quarter Results
GERMANTOWN, Md., November 10, 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 September 30, 2020.
Business Highlights for 2020 to date.
During 2020, the Company achieved the following business milestones:
| · | Completed offerings resulting in net proceeds of over $14.7 million. |
| · | Continued progress on both the Company’s out-licensing effort to partner NSI-566 and NSI-189 programs and initiative to in-license or acquire novel therapeutics. |
| · | Appointed Matthew W. Kalnik, Ph.D. as President and Chief Operating Officer and Dane R. Saglio as Chief Financial Officer. |
| · | Announced the completion of the last subject’s follow-up assessment in the Company's non-GCP Phase II trial evaluating NSI-566, for the treatment of chronic ischemic stroke. |
| · | 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 September 30, 2020
Cash Position and Liquidity: At September 30, 2020, cash was approximately $12.7 million as compared to approximately $15.8 million at June 30, 2020.
Operating Loss: Operating loss for the quarter ended September 30, 2020 was $2.3 million compared to a loss of $2.1 million for the comparable 2019 period. For the nine-month period ended September 30, 2020, the operating loss was $6.3 million versus $6.5 million for the nine months ended September 30, 2019. 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 quarter ended September 30, 2020 was $2.3 million, or $0.13 per share, compared to a loss of $1.8 million, or $0.59 per share on a post-reverse stock-split basis, for the same period in 2019. For the 2020 nine-month period the net loss was $11.8 million, or $0.93 per share versus a net loss of $6.3 million, or $4.80 per share for the same period in 2019. The 2020 increase in net loss was primarily attributed to a non-cash expense of $5.6 million related to the January 2020 warrant inducement transaction.
Seneca Biopharma, Inc.
Unaudited Condensed Consolidated Balance Sheets
| September 30, | December 31, | |||||||
| 2020 | 2019 | |||||||
| ASSETS | ||||||||
| CURRENT ASSETS | ||||||||
| Cash and cash equivalents | $ | 12,651,728 | $ | 5,114,917 | ||||
| Trade and other receivables | 8,779 | 21,064 | ||||||
| Prepaid expenses | 1,431,398 | 510,900 | ||||||
| Assets held for sale | 899,538 | - | ||||||
| Total current assets | 14,991,443 | 5,646,881 | ||||||
| Property and equipment, net | 15,040 | 41,036 | ||||||
| Patents, net | 152,625 | 668,936 | ||||||
| ROU and other assets | 10,439 | 227,036 | ||||||
| Total assets | $ | 15,169,547 | $ | 6,583,889 | ||||
| LIABILITIES AND STOCKHOLDERS' EQUITY | ||||||||
| CURRENT LIABILITIES | ||||||||
| Accounts payable and accrued expenses | $ | 577,558 | $ | 824,406 | ||||
| Accrued bonuses | 98,750 | 135,686 | ||||||
| Short-term note and other current liabilities | - | 264,665 | ||||||
| Liabilities associated with assets held for sale | 325,812 | |||||||
| Total current liabilities | 1,002,120 | 1,224,757 | ||||||
| Warrant liabilities, at fair value | 44,954 | 84,596 | ||||||
| Lease liability, net of current portion | - | 148,543 | ||||||
| Total liabilities | 1,047,074 | 1,457,896 | ||||||
| STOCKHOLDERS' EQUITY | ||||||||
| Preferred stock, 7,000,000 shares authorized, $0.01 par value; 200,000 shares issued and outstanding at September 30, 2020 and December 31, 2019 | 2,000 | 2,000 | ||||||
| Common stock, $0.01 par value; 300,000,000 shares authorized, 17,295,703 and 3,866,457 shares issued and outstanding at September 30, 2020 and December 31, 2019, respectively | 172,957 | 38,665 | ||||||
| Additional paid-in capital | 247,775,027 | 227,067,058 | ||||||
| Accumulated other comprehensive loss | (3,986 | ) | (6,186 | ) | ||||
| Accumulated deficit | (233,823,525 | ) | (221,975,544 | ) | ||||
| Total stockholders' equity | 14,122,473 | 5,125,993 | ||||||
| Total liabilities and stockholders' equity | $ | 15,169,547 | $ | 6,583,889 | ||||
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Seneca Biopharma, Inc.
Unaudited Condensed Consolidated Statements of Operations and Comprehensive Loss
| Three Months Ended September 30, | Nine Months Ended September 30, | |||||||||||||||
| 2020 | 2019 | 2020 | 2019 | |||||||||||||
| Revenues | $ | 2,500 | $ | 2,500 | $ | 11,020 | $ | 12,894 | ||||||||
| Operating expenses: | ||||||||||||||||
| Research and development expenses | 466,014 | 825,486 | 1,608,935 | 3,294,402 | ||||||||||||
| General and administrative expenses | 1,880,122 | 1,301,189 | 4,683,539 | 3,217,613 | ||||||||||||
| Total operating expenses | 2,346,136 | 2,126,675 | 6,292,474 | 6,512,015 | ||||||||||||
| Operating loss | (2,343,636 | ) | (2,124,175 | ) | (6,281,454 | ) | (6,499,121 | ) | ||||||||
| Other income (expense): | ||||||||||||||||
| Interest income | 7,731 | 15,234 | 27,935 | 55,086 | ||||||||||||
| Interest expense | (3,586 | ) | (1,913 | ) | (14,015 | ) | (4,437 | ) | ||||||||
| Warrant inducement expense | - | - | (5,620,089 | ) | - | |||||||||||
| Gain on fair value of liability classified warrants | 17,669 | 320,785 | 39,642 | 416,796 | ||||||||||||
| Other income (expense) | - | 26,935 | - | (282,371 | ) | |||||||||||
| Total other income (expense) | 21,814 | 361,041 | (5,566,527 | ) | 185,074 | |||||||||||
| Net loss | $ | (2,321,822 | ) | $ | (1,763,134 | ) | $ | (11,847,981 | ) | $ | (6,314,047 | ) | ||||
| Net loss per share - basic and diluted | $ | (0.13 | ) | $ | (0.59 | ) | $ | (0.93 | ) | $ | (4.80 | ) | ||||
| Weighted average common shares outstanding - basic and diluted | 17,306,672 | 2,975,779 | 12,713,094 | 1,316,597 | ||||||||||||
| Comprehensive loss: | ||||||||||||||||
| Net loss | $ | (2,321,822 | ) | $ | (1,763,134 | ) | $ | (11,847,981 | ) | $ | (6,314,047 | ) | ||||
| Foreign currency translation adjustment | 3,180 | (4,501 | ) | 2,200 | (7,257 | ) | ||||||||||
| Comprehensive loss | $ | (2,318,642 | ) | $ | (1,767,635 | ) | $ | (11,845,781 | ) | $ | (6,321,304 | ) | ||||
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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 filed with the Securities and Exchange Commission (SEC), including its Annual Report on Form 10-K for the year ended December 31, 2019, its Quarterly Reports on Form 10-Q as well as 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
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