– Enrollment continues in second cohort of EnACT study of MAT2203 (oral amphotericin b) in cryptococcal meningitis; Data and Safety Monitoring Board (DSMB) evaluation of safety and efficacy data from second cohort anticipated Q3 2021 –
– MAT2501 (oral amikacin) advanced into preclinical toxicology and efficacy studies; completion of Phase 1 SAD study in healthy volunteers anticipated by end of 2021 –
– Matinas to host virtual R&D Day on June 17, 2021 to highlight LNC platform and related programs –
– Data from ENHANCE-IT study of LYPDISO™ against Vascepa® reported in Q1 2021 support continued development of LYPDISO as a potential best-in-class prescription-only omega-3 for cardiovascular risk reduction; partnership process ongoing –
– Management to host conference call today, Monday, May 10th, at 8:00 a.m. ET –
BEDMINSTER, N.J., May 10, 2021 (GLOBE NEWSWIRE) -- Matinas BioPharma Holdings, Inc. (NYSE AMER: MTNB), a biopharmaceutical company focused on improving the intracellular delivery of critical therapeutics through its paradigm-changing lipid nanocrystal (LNC) delivery platform, today reported financial results for the first quarter ended March 31, 2021, along with a corporate update.
First Quarter Highlights and Looking Ahead
- Patient enrollment in Cohort Two of the EnACT study (Encochleated Oral Amphotericin for Cryptococcal Meningitis Trial) has reached approximately 70 percent; DSMB evaluation of full safety and efficacy data from Cohort Two is anticipated in the third quarter of 2021.
- The Company has advanced MAT2501 into preclinical toxicology and efficacy studies, with the goal of completing a Phase 1 single ascending dose (SAD) pharmacokinetic study in healthy volunteers by the end of 2021. The Company expects to initiate a Phase 2 program in cystic fibrosis patients with nontuberculous mycobacterial infections in 2022 following successful completion of the Phase 1 SAD study.
- Following the announcement of its collaboration with the National Institutes of Allergy and Infectious Disease (NIAID) in December 2020 to create and evaluate oral formulations of Gilead’s antiviral remdesivir, the Company recently prepared and delivered several formulations to NIAID and expects to receive data from the first in vitro studies in the near term.
- The Company is pleased to announce that it will hold a virtual R&D Day on June 17, 2021. The management team plans to provide an overview of the Company’s LNC platform, including a detailed discussion on the platform’s clinical programs.
- The process of identifying and securing one or more partners for LYPDISO is ongoing, with interested parties globally, including in the United States, European Union and China.
“We are excited by the opportunities ahead for our LNC platform and associated drug candidates, and have made meaningful progress since the beginning of 2021,” commented Jerome D. Jabbour, Chief Executive Officer of Matinas. “Specifically, we continue to advance MAT2203 in cryptococcal meningitis through Cohort 2 of the EnACT trial towards its next DSMB review, which is anticipated in the third quarter of 2021. We believe that Cohort 2 data will further validate the LNC platform and highlight its ability to facilitate oral bioavailability and carry molecules safely and effectively across the blood-brain barrier in combating this deadly invasive fungal infection. We will also take the opportunity to present these data to the U.S. Food and Drug Administration in discussions about further accelerating development of MAT2203. In addition, we have advanced MAT2501 into preclinical toxicology and efficacy studies, with the goal of developing the first oral aminoglycoside for the treatment of nontuberculous mycobacterial infections, as well as gram negative bacterial infections. Finally, we continue to expand the application of the LNC platform with our collaborations with Genentech and with the NIAID in creating an oral formulation of Gilead’s remdesivir.”
First Quarter 2021 Financial Results
Cash, cash equivalents and marketable securities at March 31, 2021, were approximately $60.7 million, compared to $58.7 million at December 31, 2020.
In July 2020, the Company entered into an At-The-Market Sales Agreement (Sales Agreement) with BTIG, LLC (BTIG), pursuant to which the Company may offer and sell, from time to time, through BTIG, shares of its common stock having an aggregate offering price of up to $50 million, subject to certain limitations on the amount of common stock that may be offered and sold by the Company set forth in the Sales Agreement. During the first quarter of 2021, BTIG sold approximately 3 million shares of the Company’s common stock under the Sales Agreement generating net proceeds to the Company of approximately $5.6 million.
Based on current projections, the Company believes that cash on hand is sufficient to fund operations into 2024.
For the first quarter of 2021, net loss attributable to common shareholders was $5.2 million, or a net loss of $0.03 per share (basic and diluted). These results are identical to those of the first quarter of 2020.
Research and development expenses for the first quarter of 2021 were $3.2 million, compared to $4.1 million for the same period in 2020. The decrease was primarily due to the completion of the ENHANCE-IT study of LYPDISO in January 2021.
General and administrative expenses for the first quarter of 2021 were $3.1 million, compared to $2.3 million in the same period in 2020. The increase was primarily due to higher compensation expense related to the exercise of stock options during the first quarter of 2021.
*Vascepa® is a registered trademark of the Amarin group of companies.
Conference Call and Webcast Details
The Company will host a live conference call and webcast to discuss these results today, Monday, May 10, 2021, at 8:00 a.m. ET.
To participate in the call, please dial (877) 407-5976 (Toll-Free) or (412) 902-0031 (Toll) and reference conference ID 13719092. The live webcast will be accessible on the Investors section of Matinas’ website, www.matinasbiopharma.com, and archived for 90 days.
About Matinas BioPharma
Matinas BioPharma is a biopharmaceutical company focused on improving the intracellular delivery of critical therapeutics through its proprietary lipid nanocrystal (LNC) delivery platform. Company leadership has a deep history and knowledge of drug development and is supported by a world-class team of scientific advisors.
Matinas is developing a portfolio of products based upon its proprietary LNC drug delivery platform, which can solve complex challenges relating to the safe and effective intracellular delivery of both small and larger, more complex molecules.
MAT2203 is an oral, LNC formulation of the well-known, but highly toxic, antifungal medicine amphotericin B, primarily used to treat serious invasive fungal infections. MAT2203 is currently in a Phase 2 open-label, sequential cohort study (EnACT) in HIV-infected patients with cryptococcal meningitis. EnACT is currently enrolling patients in its second cohort, with the next DSMB evaluation of safety and efficacy data anticipated to occur in the third quarter of 2021.
MAT2501 is an oral, LNC formulation of the broad-spectrum aminoglycoside antibiotic medicine amikacin, primarily used to treat chronic and acute bacterial infections. The Company has been awarded up to $3.75 million from the Cystic Fibrosis Foundation (CFF) to support development of MAT2501 toward an indication to treat nontuberculous mycobacterial (NTM) lung disease, including infections in patients with cystic fibrosis (CF).
Each of MAT2203 and MAT2501 has received Qualified Infectious Disease Product (QIDP) and Orphan Drug designations which, upon approval, could potentially provide up to twelve years of regulatory marketing exclusivity for each product.
LYPDISO™, the Company’s product candidate intended for the treatment of cardiovascular and metabolic conditions, is a prescription-only omega-3 fatty acid-based composition, comprised primarily of EPA and DPA, recently announced data from the ENHANCE-IT study, a head-to-head crossover study evaluating LYPDISO vs. Vascepa in patients with elevated triglycerides. Data demonstrating superior levels of eicosapentaenoic acid (EPA) in the blood with LYPDISO support the potential superior cardioprotective effect of LYPDISO vs. Vascepa. The Company has initiated a process to identity and secure a potential partner to continue development of LYPDISO toward a cardiovascular outcomes indication.
Forward Looking Statements
This release contains "forward-looking statements" within the meaning of the Private Securities Litigation Reform Act of 1995, including those relating to the LNC platform delivery technology, the Company’s strategic focus and the future development of its product candidates, including MAT2203, MAT2501 and LYPDISO, the anticipated timing of regulatory submissions, the anticipated timing of clinical studies, the anticipated timing of regulatory interactions, the Company’s ability to identify and pursue development and partnership opportunities for its products or platform delivery technology on favorable terms, if at all, and the ability to obtain required regulatory approval and other statements that are predictive in nature, that depend upon or refer to future events or conditions. All statements other than statements of historical fact are statements that could be forward-looking statements. Forward-looking statements include words such as "expects," "anticipates," "intends," "plans," "could," "believes," "estimates" and similar expressions. These statements involve known and unknown risks, uncertainties and other factors which may cause actual results to be materially different from any future results expressed or implied by the forward-looking statements. Forward-looking statements are subject to a number of risks and uncertainties, including, but not limited to, our ability to obtain additional capital to meet our liquidity needs on acceptable terms, or at all, including the additional capital which will be necessary to complete the clinical trials of our product candidates; our ability to successfully complete research and further development and commercialization of our product candidates; the uncertainties inherent in clinical testing; the timing, cost and uncertainty of obtaining regulatory approvals; our ability to protect the Company’s intellectual property; the loss of any executive officers or key personnel or consultants; competition; changes in the regulatory landscape or the imposition of regulations that affect the Company’s products; and the other factors listed under "Risk Factors" in our filings with the SEC, including Forms 10-K, 10-Q and 8-K. Investors are cautioned not to place undue reliance on such forward-looking statements, which speak only as of the date of this release. Except as may be required by law, the Company does not undertake any obligation to release publicly any revisions to such forward-looking statements to reflect events or circumstances after the date hereof or to reflect the occurrence of unanticipated events. Matinas BioPharma’s product candidates are all in a development stage and are not available for sale or use.
| Matinas BioPharma Holdings Inc. | ||||||||||||
| Condensed Consolidated Balance Sheets | ||||||||||||
| March 31, 2021 | December 31, 2020 | |||||||||||
| (Unaudited) | (Audited) | |||||||||||
| ASSETS: | ||||||||||||
| Current assets: | ||||||||||||
| Cash and cash equivalents | $ | 23,382,743 | $ | 12,432,481 | ||||||||
| Marketable securities | 37,283,697 | 46,246,573 | ||||||||||
| Restricted cash - security deposits | 136,000 | 136,000 | ||||||||||
| Prepaid expenses and other current assets | 2,333,225 | 2,739,791 | ||||||||||
| Total current assets | 63,135,665 | 61,554,845 | ||||||||||
| Non-current assets: | ||||||||||||
| Leasehold improvements and equipment - net | 1,465,303 | 1,523,950 | ||||||||||
| Operating lease right-of-use assets - net | 3,149,744 | 3,276,639 | ||||||||||
| Finance lease right-of-use assets - net | 45,992 | 58,007 | ||||||||||
| In-process research and development | 3,017,377 | 3,017,377 | ||||||||||
| Goodwill | 1,336,488 | 1,336,488 | ||||||||||
| Restricted cash - security deposits | 200,000 | 200,000 | ||||||||||
| Total non-current assets | 9,214,904 | 9,412,461 | ||||||||||
| Total assets | $ | 72,350,569 | $ | 70,967,306 | ||||||||
| LIABILITIES AND STOCKHOLDERS' EQUITY: | ||||||||||||
| Current liabilities: | ||||||||||||
| Accounts payable | $ | 421,645 | $ | 349,941 | ||||||||
| Accrued expenses | 1,405,745 | 2,795,329 | ||||||||||
| Operating lease liabilities - current | 364,566 | 391,498 | ||||||||||
| Financing lease liabilities - current | 29,396 | 30,853 | ||||||||||
| Total current liabilities | 2,221,352 | 3,567,621 | ||||||||||
| Non-current liabilities: | ||||||||||||
| Deferred tax liability | 341,265 | 341,265 | ||||||||||
| Operating lease liabilities - net of current portion | 3,214,714 | 3,304,063 | ||||||||||
| Financing lease liabilities - net of current portion | 17,134 | 23,660 | ||||||||||
| Total non-current liabilities | 3,573,113 | 3,668,988 | ||||||||||
| Total liabilities | 5,794,465 | 7,236,609 | ||||||||||
| Stockholders' equity: | ||||||||||||
| Series B Convertible preferred stock | 3,673,176 | 3,797,705 | ||||||||||
| Common stock | 20,427 | 20,010 | ||||||||||
| Additional paid-in capital | 175,189,608 | 167,192,003 | ||||||||||
| Accumulated deficit | (112,463,513 | ) | (107,507,193 | ) | ||||||||
| Accumulated other comprehensive income/(loss) | 136,406 | 228,172 | ||||||||||
| Total stockholders' equity | 66,556,104 | 63,730,697 | ||||||||||
| Total liabilities and stockholders' equity | $ | 72,350,569 | $ | 70,967,306 | ||||||||
| Matinas BioPharma Holdings, Inc. | |||||||||
| Condensed Consolidated Statements of Operations and Comprehensive Loss | |||||||||
| (Unaudited) | |||||||||
| Three Months Ended March 31, | |||||||||
| 2021 | 2020 | ||||||||
| Revenue: | |||||||||
| Contract research revenue | $ | 33,333 | $ | - | |||||
| Costs and expenses: | |||||||||
| Research and development | 3,241,432 | 4,086,883 | |||||||
| General and administrative | 3,145,010 | 2,259,631 | |||||||
| Total costs and expenses | 6,386,442 | 6,346,514 | |||||||
| Loss from operations | (6,353,109 | ) | (6,346,514 | ) | |||||
| Sale of New Jersey net operating loss | 1,328,470 | 1,073,289 | |||||||
| Other income, net | 68,319 | 227,327 | |||||||
| Net loss | $ | (4,956,320 | ) | $ | (5,045,898 | ) | |||
| Preferred stock series B accumulated dividends | (210,900 | ) | (170,700 | ) | |||||
| Net loss attributable to common shareholders | $ | (5,167,220 | ) | $ | (5,216,598 | ) | |||
| Net loss available for common shareholders per share - basic and diluted | $ | (0.03 | ) | $ | (0.03 | ) | |||
| Weighted average common shares outstanding - basic and diluted | 203,871,820 | 191,671,153 | |||||||
| Other comprehensive (loss)/income, net of tax | |||||||||
| Unrealized (loss)/gains on securities available-for-sale | (91,766 | ) | 523,246 | ||||||
| Other comprehensive (loss)/income, net of tax | (91,766 | ) | 523,246 | ||||||
| Comprehensive loss attributable to stockholders | $ | (5,048,086 | ) | $ | (4,522,652 | ) | |||
Investor and Media Contacts
Peter Vozzo
Westwicke/ICR
443-213-0505
peter.vozzo@westwicke.com
Source: Matinas BioPharma Holdings, Inc.