8-K
Matinas BioPharma Holdings, Inc. (MTNB)
UNITED
STATES
SECURITIES
AND EXCHANGE COMMISSION
Washington,
D.C. 20549
FORM
8-K
CURRENT
REPORT
Pursuant
to Section 13 or 15(d) of
The
Securities Exchange Act of 1934
Date
of Report (Date of earliest event reported):
August10, 2021
MATINAS
BIOPHARMA HOLDINGS, INC.
(Exactname of registrant as specified in its charter)
| Delaware | 001-38022 | 46-3011414 |
|---|---|---|
| (State or other jurisdiction <br><br> of incorporation) | (Commission <br><br> File Number) | (IRS Employer <br><br> ID Number) |
| 1545 Route 206 South, Suite 302<br><br> <br>Bedminster, New Jersey | 07921 | |
| --- | --- | |
| (Address of principal executive offices) | (Zip Code) |
Registrant’stelephone number, including area code: (908) ### 443-1860
NotApplicable
(Formername or former address, if changed since last report.)
Check the appropriate box below if the Form 8-K filing is intended to simultaneously satisfy the filing obligation of the registrant under any of the following provisions (see General Instruction A.2. below):
| ☐ | Written<br> communications pursuant to Rule 425 under the Securities Act (17 CFR 230.425) |
|---|---|
| ☐ | Soliciting<br> material pursuant to Rule 14a-12 under the Exchange Act (17 CFR 240.14a-12) |
| ☐ | Pre-commencement<br> communications pursuant to Rule 14d-2(b) under the Exchange Act (17 CFR 240.14d-2(b)) |
| ☐ | Pre-commencement<br> communications pursuant to Rule 13e-4(c) under the Exchange Act (17 CFR 240.13e-4(c)) |
Securities registered pursuant to Section 12(b) of the Act:
| Title<br> of Each Class | Trading<br> Symbol | Name<br> of Each Exchange on Which Registered |
|---|---|---|
| Common<br> Stock | MTNB | NYSE<br> American |
Indicate by check mark whether the registrant is an emerging growth company as defined in Rule 405 of the Securities Act of 1933 (17 CFR §230.405) or Rule 12b-2 of the Securities Exchange Act of 1934 (17 CFR §240.12b-2).
Emerging growth company ☐
If an emerging growth company, indicate by check mark if the registrant has elected not to use the extended transition period for complying with any new or revised financial accounting standards provided pursuant to Section 13(a) of the Exchange Act. ☐
Item2.02. Results of Operations and Financial Condition.
On August 10, 2021, Matinas BioPharma Holdings, Inc. (the “Company”) issued a press release announcing its financial results for the quarter ended June 30, 2021. The full text of the press release is furnished as Exhibit 99.1 hereto and is incorporated by reference herein.
The information in Item 2.02 of this Current Report on Form 8-K and Exhibit 99.1 attached hereto shall not be deemed “filed” for purposes of Section 18 of the Securities Exchange Act of 1934, as amended (the “Exchange Act”), or otherwise subject to the liabilities of that Section, nor shall such information be deemed incorporated by reference in any filing under the Securities Act of 1933, as amended (the “Securities Act”), or the Exchange Act, except as shall be expressly set forth by specific reference in such a filing.
Item9.01. Financial Statements and Exhibits.
(d) The following exhibits are being furnished with this report:
| Exhibit<br> No. | Description |
|---|---|
| 99.1 | Press Release, dated August 10, 2021. |
| -2- |
| --- |
SIGNATURES
Pursuant to the requirements of the Securities Exchange Act of 1934, the registrant has duly caused this report to be signed on its behalf by the undersigned hereunto duly authorized.
| MATINAS BIOPHARMA HOLDINGS, INC. | ||
|---|---|---|
| Dated:<br> August 10, 2021 | By: | /s/ Jerome D. Jabbour |
| Name: | Jerome<br> D. Jabbour | |
| Title: | Chief<br> Executive Officer |
| -3- |
| --- |
Exhibit 99.1
Matinas BioPharma Reports Second Quarter 2021 FinancialResults and Operational Highlights
– Enrollment complete in second cohort of EnACT studyof MAT2203 (oral amphotericin B) in cryptococcal meningitis; Data and Safety Monitoring Board (DSMB) review of safety and efficacy datafrom second cohort anticipated September 2021 –
– 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) formulationsof Gilead Sciences’ remdesivir demonstrate meaningful efficacy compared to free remdesivir, with a favorable toxicity profile; NationalInstitute of Allergy and Infectious Diseases (NIAID) preparing to initiate an in vivo efficacy study of LNC-remdesivir in Q3 2021 –
– Management to host conference call today, Tuesday,August 10^th^, at 8:00 a.m. ET –
BEDMINSTER, N.J., August 10, 2021 – Matinas BioPharma Holdings, Inc. (NYSE AMER: MTNB), a clinical-stage biopharmaceutical company focused on improving the intracellular delivery of critical therapeutics through its paradigm-changing lipid nanocrystal (LNC) platform delivery technology, today reported financial results for the second quarter ended June 30, 2021, along with a corporate update.
Second Quarter Highlights and Looking Ahead
| ● | Completed patient enrollment in Cohort 2 of the EnACT study (Encochleated Oral Amphotericin for CryptococcalMeningitis Trial); DSMB evaluation of available safety and efficacy data from Cohort 2 expected in September 2021. The Company plans<br>to announce efficacy and safety data from the first two cohorts of EnACT together with Dr. David Boulware, Principal Investigator, following<br>the DSMB evaluation. |
|---|---|
| ● | Following the EnACT data announcement, the Company plans to meet with the U.S. Food and Drug Administration<br>(FDA) in the fourth quarter of 2021 to discuss the potential for approval of MAT2203 under one or more accelerated regulatory pathways<br>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<br>in healthy volunteers in the fourth quarter of 2021. Initiation of the Phase 1 SAD study follows positive feedback received from the FDA<br>on the Company’s ongoing preclinical toxicology and efficacy studies of MAT2501 conducted in collaboration with the Cystic Fibrosis<br>Foundation (CFF). |
| --- | --- |
| ● | The Company and NIAID have successfully completed in vitro studies of various LNC formulations<br>of Gilead’s antiviral drug remdesivir. Selected LNC-remdesivir formulations were tested for antiviral activity against SARS-CoV2<br>WA strain in Caco-2 cells. Unformulated remdesivir active (GS-5734, in DMSO) was tested as a comparison. LNC formulations tested in this<br>model demonstrated meaningful antiviral activity compared to free remdesivir, with a favorable toxicity profile. Based on these results,<br>NIAID is preparing to initiate an in vivo efficacy study of the most potent LNC-remdesivir formulation. Results are expected in<br>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 Jerome D. Jabbour, Chief Executive Officer of Matinas. “We have made great progress with MAT2203 and MAT2501, both of which represent large potential commercial opportunities for Matinas. Completion of Cohort 2 of EnACT provides an important milestone and further validation for our LNC platform. In addition to potentially demonstrating that MAT2203 can be a safe and effective step-down oral therapy for patients with cryptococcal meningitis, we believe that the data from Cohort 2 will support a key regulatory interaction later in 2021 for a potential early registration pathway for MAT2203 as step-down therapy for patients suffering from cryptococcal meningitis. In addition, recent positive feedback from the FDA on our ongoing preclinical program with MAT2501 now positions us to initiate the Phase 1 SAD study for MAT2501 in the fourth quarter of 2021.”
“Finally, we are extremely pleased with the positive in vitro data that we have reviewed from NIAID with our LNC-remdesivir formulations,” continued Mr. Jabbour. “The success of our LNC platform in vitro has provided further evidence that our LNC platform can be utilized to orally administer drugs currently otherwise limited to intravenous delivery. An oral version of Gilead’s remdesivir could become an essential tool in the fight against COVID-19, as it may permit administration earlier in the disease course as well as potential for prophylactic use, should clinical studies validate such an approach. We are honored to continue to partner with NIAID on this important project and look forward to additional invivo data later in 2021.”
Second Quarter 2021 Financial Results
Cash, cash equivalents and marketable securities at June 30, 2021, were approximately $59.8 million, compared to $58.7 million at December 31, 2020. Based on current projections, the Company believes that cash on hand is sufficient to fund operations into 2024.
For the second quarter of 2021, net loss attributable to common shareholders was $5.0 million, or a net loss of $0.02 per share (basic and diluted), compared to a net loss attributable to common shareholders of $5.8 million, or a net loss of $0.03 per share (basic and diluted), for the same period in 2020. The decrease was due primarily to a reduction in research and development expenses, as more fully described below.
Research and development expenses for the second quarter of 2021 were $2.5 million, compared to $3.4 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 second quarter of 2021 were $2.3 million, essentially unchanged compared to $2.4 million in the same period in 2020.
Conference Call and Webcast Details
The Company will host a live conference call and webcast to discuss these results today, Tuesday, August 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 13720567. 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 paradigm-changing lipid nanocrystal (LNC) delivery platform. The Company is developing its own internal portfolio of products as well as partnering with leading pharmaceutical companies to develop new formulations that take full advantage of the unique characteristics of the LNC platform.
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 September 2021.
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 Cystic Fibrosis Foundation, MAT2501 is currently undergoing important preclinical studies and expects to enter a Phase 1 human clinical trial later in 2021. MAT2501 would be the first and only oral aminoglycoside and is being positioned with an initial indication for the treatment of nontuberculous mycobacterial (NTM) lung disease, including infections in patients with cystic fibrosis (CF).
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 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.
MatinasBioPharma Holdings Inc.
CondensedConsolidated Balance Sheets
| June<br> 30, 2021 | December<br> 31, 2020 | |||||
|---|---|---|---|---|---|---|
| (Unaudited) | (Audited) | |||||
| ASSETS: | ||||||
| Current assets: | ||||||
| Cash<br> and cash equivalents | $ | 30,352,359 | $ | 12,432,481 | ||
| Marketable<br> securities | 29,490,430 | 46,246,573 | ||||
| Restricted<br> cash - security deposits | 136,000 | 136,000 | ||||
| Prepaid<br> expenses and other current assets | 960,422 | 2,739,791 | ||||
| Total<br> current assets | 60,939,211 | 61,554,845 | ||||
| Non-current assets: | ||||||
| Leasehold<br> improvements and equipment - net | 1,406,748 | 1,523,950 | ||||
| Operating<br> lease right-of-use assets - net | 3,034,155 | 3,276,639 | ||||
| Finance<br> lease right-of-use assets - net | 37,350 | 58,007 | ||||
| In-process<br> research and development | 3,017,377 | 3,017,377 | ||||
| Goodwill | 1,336,488 | 1,336,488 | ||||
| Restricted<br> cash - security deposits | 200,000 | 200,000 | ||||
| Total<br> non-current assets | 9,032,118 | 9,412,461 | ||||
| Total<br> assets | $ | 69,971,329 | $ | 70,967,306 | ||
| LIABILITIES<br> AND STOCKHOLDERS’ EQUITY: | ||||||
| Current<br> liabilities: | ||||||
| Accounts<br> payable | $ | 450,461 | $ | 349,941 | ||
| Accrued<br> expenses | 2,762,736 | 2,795,329 | ||||
| Operating<br> lease liabilities - current | 351,257 | 391,498 | ||||
| Financing<br> lease liabilities - current | 26,870 | 30,853 | ||||
| Total<br> current liabilities | 3,591,324 | 3,567,621 | ||||
| Non-current liabilities: | ||||||
| Deferred<br> tax liability | 341,265 | 341,265 | ||||
| Operating<br> lease liabilities - net of current portion | 3,123,482 | 3,304,063 | ||||
| Financing<br> lease liabilities - net of current portion | 11,508 | 23,660 | ||||
| Total<br> non-current liabilities | 3,476,255 | 3,668,988 | ||||
| Total<br> liabilities | 7,067,579 | 7,236,609 | ||||
| Stockholders’ equity: | ||||||
| Series<br> B Convertible preferred stock | - | 3,797,705 | ||||
| Common<br> stock | 21,462 | 20,010 | ||||
| Additional<br> paid-in capital | 180,929,263 | 167,192,003 | ||||
| Accumulated<br> deficit | (118,098,218 | ) | (107,507,193 | ) | ||
| Accumulated<br> other comprehensive income | 51,243 | 228,172 | ||||
| Total<br> stockholders’ equity | 62,903,750 | 63,730,697 | ||||
| Total<br> liabilities and stockholders’ equity | $ | 69,971,329 | $ | 70,967,306 |
MatinasBioPharma Holdings, Inc.
CondensedConsolidated Statements of Operations and Comprehensive Loss
(Unaudited)
| Three<br> Months Ended June 30, | Six<br> Months Ended June 30, | |||||||||||
|---|---|---|---|---|---|---|---|---|---|---|---|---|
| 2021 | 2020 | 2021 | 2020 | |||||||||
| Revenue: | ||||||||||||
| Research<br> and development | $ | - | $ | - | $ | 33,333 | $ | - | ||||
| Costs and expenses: | ||||||||||||
| Research<br> and development | 2,480,764 | 3,410,237 | 5,722,196 | 7,497,120 | ||||||||
| General<br> and administrative | 2,308,926 | 2,356,310 | 5,453,936 | 4,615,941 | ||||||||
| Total<br> 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<br> New Jersey net operating loss & tax credits | - | - | 1,328,470 | 1,073,289 | ||||||||
| Other<br> 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<br> stock series B accumulated dividends | (184,899 | ) | (177,092 | ) | (395,799 | ) | (347,792 | ) | ||||
| Net<br> loss attributable to common shareholders | $ | (4,976,004 | ) | (5,787,639 | ) | $ | (10,143,224 | ) | $ | (11,004,237 | ) | |
| Net<br> loss available for common shareholders per share - basic and diluted | $ | (0.02 | ) | (0.03 | ) | $ | (0.05 | ) | $ | (0.06 | ) | |
| Weighted<br> average common shares outstanding - basic and diluted | 205,215,259 | 197,601,500 | 204,547,251 | 194,636,326 | ||||||||
| Other comprehensive (loss)/income,<br> net of tax | ||||||||||||
| Unrealized<br> (loss)/gains on securities available-for-sale | (85,163 | ) | (41,954 | ) | (176,929 | ) | 481,303 | |||||
| Reclassification<br> to net loss | - | (2,708 | ) | - | (2,719 | ) | ||||||
| Other<br> comprehensive (loss)/income, net of tax | (85,163 | ) | (44,662 | ) | (176,929 | ) | 478,584 | |||||
| Comprehensive<br> loss attributable to stockholders | $ | (4,876,268 | ) | $ | (5,655,209 | ) | $ | (9,924,354 | ) | $ | (10,177,861 | ) |
Investorand Media Contacts
Peter Vozzo
Westwicke/ICR
443-213-0505
peter.vozzo@westwicke.com
Source: Matinas BioPharma Holdings, Inc.