– Enrollment complete in second cohort of EnACT study of MAT2203 (oral amphotericin B) in cryptococcal meningitis; Data and Safety Monitoring Board (DSMB) review of safety and efficacy data from second cohort anticipated
– Positive recent FDA feedback on MAT2501 (oral amikacin) development program allows for initiation of Phase 1 study in healthy volunteers in Q4 2021 –
– In vitro studies of lipid nanocrystal (LNC) formulations of Gilead Sciences’ remdesivir demonstrate meaningful efficacy compared to free remdesivir, with a favorable toxicity profile;
– Management to host conference call today,
Second Quarter Highlights and Looking Ahead
- Completed patient enrollment in Cohort 2 of the EnACT study (Encochleated Oral Amphotericin for Cryptococcal Meningitis Trial); DSMB evaluation of available safety and efficacy data from Cohort 2 expected in
September 2021 . The Company plans to announce efficacy and safety data from the first two cohorts of EnACT together with Dr.David Boulware , Principal Investigator, following the DSMB evaluation. - Following the EnACT data announcement, the Company plans to meet with the
U.S. Food and Drug Administration (FDA) in the fourth quarter of 2021 to discuss the potential for approval of MAT2203 under one or more accelerated regulatory pathways for important anti-infective medicines that address significant unmet medical needs in small or vulnerable patient populations. - The Company expects to initiate a Phase 1 single ascending dose (SAD) pharmacokinetic study of MAT2501 in healthy volunteers in the fourth quarter of 2021. Initiation of the Phase 1 SAD study follows positive feedback received from the FDA on the Company’s ongoing preclinical toxicology and efficacy studies of MAT2501 conducted in collaboration with the
Cystic Fibrosis Foundation (CFF). - The Company and NIAID have successfully completed in vitro studies of various LNC formulations of Gilead’s antiviral drug remdesivir. Selected LNC-remdesivir formulations were tested for antiviral activity against SARS-CoV2 WA strain in Caco-2 cells. Unformulated remdesivir active (GS-5734, in DMSO) was tested as a comparison. LNC formulations tested in this model demonstrated meaningful antiviral activity compared to free remdesivir, with a favorable toxicity profile. Based on these results, NIAID is preparing to initiate an in vivo efficacy study of the most potent LNC-remdesivir formulation. Results are expected in the fourth quarter of 2021.
“We are very excited to have provided an in-depth look at our LNC platform during our R&D Day in June. We believe that our platform has the potential to become the next generation in safe and effective intracellular drug delivery,” commented
“Finally, we are extremely pleased with the positive in vitro data that we have reviewed from NIAID with our LNC-remdesivir formulations,” continued
Second Quarter 2021 Financial Results
Cash, cash equivalents and marketable securities at
For the second quarter of 2021, net loss attributable to common shareholders was
Research and development expenses for the second quarter of 2021 were
General and administrative expenses for the second quarter of 2021 were
Conference Call and Webcast Details
The Company will host a live conference call and webcast to discuss these results today,
To participate in the call, please dial (877) 407-5976 (Toll-Free) or (412) 902-0031 (Toll) and reference conference ID 13720567. The live webcast will be accessible on the Investors section of Matinas’ website, www.matinasbiopharma.com, and archived for 90 days.
About
Preclinical and clinical data have demonstrated that this novel technology can provide solutions to many of the complex challenges in achieving safe and effective intracellular delivery, for both small molecules and larger, more complex molecules, such as mRNA, DNA plasmids, antisense oligonucleotides and vaccines. The combination of a unique mechanism of action and flexibility in both the formulation and route of administration (including oral), position Matinas’ LNC technology to potentially become the preferred next-generation intracellular drug delivery vehicle and an important improvement over both lipid nanoparticles and viral vectors.
MAT2203 is an oral, LNC formulation of the highly effective, but also highly toxic, antifungal medicine amphotericin B, primarily used as a first-line treatment for 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 nearing the completion of enrollment of its second cohort of patients, with the next DSMB evaluation of safety and efficacy data anticipated to occur in
MAT2501 is an oral, LNC formulation of the broad-spectrum aminoglycoside antibiotic amikacin, primarily used to treat chronic and acute bacterial infections. With the support of the
LYPDISO™, is a prescription-only omega-3 fatty acid-based composition, comprised primarily of EPA and DPA, intended for the treatment of cardiovascular and metabolic conditions. This next-generation omega-3 therapy has been shown in two head-to-head studies to provide effective triglyceride-lowering and significantly higher EPA blood levels than Vascepa®. The Company has initiated a process to identity and potentially secure a partner to continue development of LYPDISO.
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, 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
Condensed Consolidated Balance Sheets | |||||||||||||
(Unaudited) | (Audited) | ||||||||||||
ASSETS: | |||||||||||||
Current assets: | |||||||||||||
Cash and cash equivalents | $ | 30,352,359 | $ | 12,432,481 | |||||||||
Marketable securities | 29,490,430 | 46,246,573 | |||||||||||
Restricted cash - security deposits | 136,000 | 136,000 | |||||||||||
Prepaid expenses and other current assets | 960,422 | 2,739,791 | |||||||||||
Total current assets | 60,939,211 | 61,554,845 | |||||||||||
Non-current assets: | |||||||||||||
Leasehold improvements and equipment - net | 1,406,748 | 1,523,950 | |||||||||||
Operating lease right-of-use assets - net | 3,034,155 | 3,276,639 | |||||||||||
Finance lease right-of-use assets - net | 37,350 | 58,007 | |||||||||||
In-process research and development | 3,017,377 | 3,017,377 | |||||||||||
1,336,488 | 1,336,488 | ||||||||||||
Restricted cash - security deposits | 200,000 | 200,000 | |||||||||||
Total non-current assets | 9,032,118 | 9,412,461 | |||||||||||
Total assets | $ | 69,971,329 | $ | 70,967,306 | |||||||||
LIABILITIES AND STOCKHOLDERS' EQUITY: | |||||||||||||
Current liabilities: | |||||||||||||
Accounts payable | $ | 450,461 | $ | 349,941 | |||||||||
Accrued expenses | 2,762,736 | 2,795,329 | |||||||||||
Operating lease liabilities - current | 351,257 | 391,498 | |||||||||||
Financing lease liabilities - current | 26,870 | 30,853 | |||||||||||
Total current liabilities | 3,591,324 | 3,567,621 | |||||||||||
Non-current liabilities: | |||||||||||||
Deferred tax liability | 341,265 | 341,265 | |||||||||||
Operating lease liabilities - net of current portion | 3,123,482 | 3,304,063 | |||||||||||
Financing lease liabilities - net of current portion | 11,508 | 23,660 | |||||||||||
Total non-current liabilities | 3,476,255 | 3,668,988 | |||||||||||
Total liabilities | 7,067,579 | 7,236,609 | |||||||||||
Stockholders' equity: | |||||||||||||
Series B Convertible preferred stock | - | 3,797,705 | |||||||||||
Common stock | 21,462 | 20,010 | |||||||||||
Additional paid-in capital | 180,929,263 | 167,192,003 | |||||||||||
Accumulated deficit | (118,098,218 | ) | (107,507,193 | ) | |||||||||
Accumulated other comprehensive income | 51,243 | 228,172 | |||||||||||
Total stockholders' equity | 62,903,750 | 63,730,697 | |||||||||||
Total liabilities and stockholders' equity | $ | 69,971,329 | $ | 70,967,306 | |||||||||
Condensed Consolidated Statements of Operations and Comprehensive Loss | |||||||||||||||||
(Unaudited) | |||||||||||||||||
Three Months Ended | Six Months Ended | ||||||||||||||||
2021 | 2020 | 2021 | 2020 | ||||||||||||||
Revenue: | |||||||||||||||||
Research and development | $ | - | $ | - | $ | 33,333 | $ | - | |||||||||
Costs and expenses: | |||||||||||||||||
Research and development | 2,480,764 | 3,410,237 | 5,722,196 | 7,497,120 | |||||||||||||
General and administrative | 2,308,926 | 2,356,310 | 5,453,936 | 4,615,941 | |||||||||||||
Total costs and expenses | 4,789,690 | 5,766,547 | 11,176,132 | 12,113,061 | |||||||||||||
Loss from operations | (4,789,690 | ) | (5,766,547 | ) | (11,142,799 | ) | (12,113,061 | ) | |||||||||
Sale of | - | - | 1,328,470 | 1,073,289 | |||||||||||||
Other income, net | (1,415 | ) | 156,000 | 66,904 | 383,327 | ||||||||||||
Net loss | $ | (4,791,105 | ) | $ | (5,610,547 | ) | $ | (9,747,425 | ) | $ | (10,656,445 | ) | |||||
Preferred stock series B accumulated dividends | (184,899 | ) | (177,092 | ) | (395,799 | ) | (347,792 | ) | |||||||||
Net loss attributable to common shareholders | $ | (4,976,004 | ) | (5,787,639 | ) | $ | (10,143,224 | ) | $ | (11,004,237 | ) | ||||||
Net loss available for common shareholders per share - basic and diluted | $ | (0.02 | ) | (0.03 | ) | $ | (0.05 | ) | $ | (0.06 | ) | ||||||
Weighted average common shares outstanding - basic and diluted | 205,215,259 | 197,601,500 | 204,547,251 | 194,636,326 | |||||||||||||
Other comprehensive (loss)/income, net of tax | |||||||||||||||||
Unrealized (loss)/gains on securities available-for-sale | (85,163 | ) | (41,954 | ) | (176,929 | ) | 481,303 | ||||||||||
Reclassification to net loss | - | (2,708 | ) | - | (2,719 | ) | |||||||||||
Other comprehensive (loss)/income, net of tax | (85,163 | ) | (44,662 | ) | (176,929 | ) | 478,584 | ||||||||||
Comprehensive loss attributable to stockholders | $ | (4,876,268 | ) | $ | (5,655,209 | ) | $ | (9,924,354 | ) | $ | (10,177,861 | ) | |||||
Investor and Media Contacts
Westwicke/ICR
443-213-0505
peter.vozzo@westwicke.com
Source:
Source:
2021 GlobeNewswire, Inc., source