OREANDA-NEWS. Matinas BioPharma Holdings, Inc. (NYSE MKT:MTNB), a clinical-stage biopharmaceutical company focused on developing innovative anti-infectives for orphan indications, today announced its financial results for the quarter ended September 30, 2017 and reviewed its operational progress of its lead anti-infective products in development and expected near-term milestones.

“In the third quarter, our team worked with leading key opinion leaders and our clinical and regulatory advisors to analyze in great detail a compilation of very encouraging preclinical and clinical data generated for MAT2003. Patients undergoing treatment for acute lymphoblastic leukemia (ALL), a blood-borne cancer, are at high risk for invasive fungal infections (IFIs) due to their specific chemotherapy. The profile of MAT2203 uniquely positions it to significantly reduce the occurrence of potentially lethal IFIs in these patients. We believe the compelling MAT2203 data package, combined with the proposed clinical and regulatory pathway we have established, positions us to successfully engage with the FDA to move our MAT2203 clinical development program forward to a pivotal Phase 3 registration study for the prevention of IFIs,” stated Roelof Rongen, Chief Executive Officer of Matinas. “Our team continues to work diligently to establish a clear path forward for our development programs as we complete the remainder of 2017 and work towards creating significant value-driving events throughout 2018.”

ANTIFUNGAL MAT2203 RECENT ACHIEVMENTS

  • Reported topline data from Phase 2 clinical study of orally administered MAT2203 in the treatment of vulvovaginal candidiasis indicating that MAT2203 was safe and well tolerated while demonstrating signals of efficacy through a mechanism involving systemic absorption, including a dose response;
     
  • Announced positive interim data from NIH-conducted Phase 2a clinical study of orally administered MAT2203 for the treatment of chronic refractory mucocutaneous candidiasis providing for the safe and efficacious long-term use of MAT2203 (now longer than nine months without encountering safety issues); and
  • Presented positive preclinical efficacy data of MAT2203 in a mouse model of cryptococcal meningitis demonstrating dramatic improvement in treatment with MAT2203 and the ability to systemically cross the blood/brain barrier.
    • Mortality results were consistent with what has been seen in MAT2203 treated models of invasive candidiasis and invasive aspergillosis and the fluorescence images of brain tissue further support the unique ability of cochleates to penetrate deep into infected organs.

MAT2203 NEXT STEPS

  • Commence tolerability/PK study of MAT2203 in leukemia patients as a critical piece of the Phase 2 development program prior to commencing a pivotal Phase 3 registration trial in prevention of IFIs in patients with ALL. Initial data expected Q4 2018;
     
  • Conduct Type B Meeting (face-to-face) in early Q1 2018 with FDA to review overall data package for MAT2203, the Company’s plans to finalize Phase 2 with data from its tolerability/PK study in leukemia patients and to position MAT2203 with FDA toward a Phase 3 clinical program in prevention of IFIs in patients with ALL; and
     
  • Evaluate and commence one or more studies in cryptococcal meningitis in partnership with the University of Minnesota to demonstrate patient efficacy in invasive fungal infections as a way to supplement the overall data package for MAT2203 during 2018.

ANTIBACTERIAL MAT2501 RECENT ACHIEVEMENTS

  • Reported positive topline data from the Phase 1 single-ascending dose study of MAT2501 in healthy volunteers. 
    • No serious adverse events were reported.
    • Oral administration of MAT2501 at all tested doses yielded blood levels that were well below the safety levels recommended for injected amikacin.
    • Data supports further development of MAT2501 for the treatment of non-tuberculous mycobacterium (NTM) infections.
    • Results from Phase 1 study demonstrating systemic absorption and accumulation in the urine were encouraging toward the potential for MAT2501 to treat more acute bacterial infections, such as gram negative urinary tract infections (cUTIs).

MAT2501 NEXT STEPS

  • Commence multiple-ascending dose PK/tolerability study of MAT2501 in healthy volunteers in Q2 2018;
     
  • Announce results of PK/tolerability study in Q4 2018; and
     
  • Initiate Phase 2 NTM study in Q4 2018.


Q3 2017 SUMMARY OF FINANCIAL RESULTS

For the nine months ended September 30, 2017, the Company reported a net loss of approximately $11.9 million, or a net loss share basic and diluted of $0.33, compared to a net loss of approximately $5.7 million, or a net loss per share basic and diluted of $0.18, for the nine months ended September 30, 2016. The net loss for the nine months ended September 30, 2017 is primarily attributable to ongoing research and development activities related to MAT2203 and MAT2501 as well as the costs associated with operating as a public company. The Company ended the quarter with cash and cash equivalents of approximately $9.0 million.

About MAT2203

MAT2203 is an orally-administered, encochleated formulation of amphotericin B (a broad spectrum fungicidal agent). Little to no clinical resistance has been reported to date with amphotericin B as compared to the rapidly emerging drug resistance seen in other antifungal therapies. Currently, IV-only administered amphotericin B is the only broad spectrum fungicidal available but its IV-delivery results in significant treatment-limiting side effects, including nephrotoxicity. The ability to provide amphotericin B orally using our proprietary and novel oral formulation may offer a new and promising alternative for patients and doctors. The FDA has designated MAT2203 as a Qualified Infectious Disease Product (QIDP) for the treatment of invasive candidiasis and the treatment of aspergillosis, as well as for the prevention of invasive fungal infections due to immunosuppressive therapy. MAT2203 is also being explored for treatment of additional anti-fungal indications and may have the potential for Orphan Drug Designation in certain of these indications.

About MAT2501

MAT2501 is an orally-administered, encochleated formulation of the broad spectrum IV-only aminoglycoside antibiotic agent amikacin, which utilizes the Company’s proprietary, lipid-crystal, nanoparticle delivery technology. Amikacin is currently used to treat different types of chronic and acute bacterial infections, including non-tuberculous mycobacterium (NTM) infections and various multidrug-resistant gram-negative bacterial infections. IV-administered amikacin is associated with major side effects including nephrotoxicity and ototoxicity (permanent loss of hearing). MAT2501 is specifically designed to provide targeted delivery of the potent antibiotic amikacin while providing a significantly improved safety and tolerability profile. In preclinical studies MAT2501 demonstrated efficacy after oral bioavailability and targeted delivery of amikacin directly to the site of infection in murine models of both pulmonary (lung) and disseminated NTM infections. The FDA has designated MAT2501 as a QIDP and an Orphan Drug for the treatment of NTM infections. The Company intends to initially develop MAT2501 for the treatment of NTM infections and is also exploring the development of MAT2501 for the treatment of a multi-drug resistant, gram negative bacterial infections. If approved, Matinas believes MAT2501 would become the first orally bioavailable aminoglycoside and represent a significant improvement over existing therapies from a treatment and health economic perspective.

About Matinas BioPharma

Matinas BioPharma is a clinical-stage biopharmaceutical company focused on developing innovative anti-infectives for orphan indications. The Company's proprietary, disruptive technology utilizes lipid-crystal nano-particle cochleates to nano-encapsulate existing drugs, making them safer, more tolerable, less toxic and orally bioavailable.

       
Matinas BioPharma Holdings, Inc.
Condensed Consolidated Statements of Operations
(Unaudited)
       
    Three Months Ended  
    September 30,  
    2017     2016  
Revenue:            
Contract research revenue   $ 44,906     $ -  
                 
Costs and Expenses:                
Research and development     2,013,063       835,308  
General and administrative     1,440,141       999,803  
                 
Total costs and expenses     3,453,204       1,835,111  
                 
Loss from operations     (3,408,298 )     (1,835,111 )
                 
Other income/(expense), net     13,584       (3,325 )
                 
Net loss   $ (3,394,714 )   $ (1,838,436 )
                 
Dividend to preferred shareholders     (608,343 )     -  
                 
Convertible preferred stock beneficial conversion feature accreted as a deemed dividend     -       (4,393,809 )
                 
Net loss attributable to common shareholders   $ (4,003,057 )   $ (6,232,245 )
                 
Net loss available for common shareholders per share - basic and diluted   $ (0.04 )   $ (0.11 )
                 
Weighted average common shares outstanding:
Basic and diluted		     92,222,601       57,628,917  
       
    Nine Months Ended  
    September 30,  
    2017     2016  
Revenue:                
Contract research revenue   $ 104,781     $ -  
                 
Costs and Expenses:                
Research and development     6,711,997       2,399,595  
General and administrative     5,264,609       3,293,233  
                 
Total costs and expenses     11,976,606       5,692,828  
                 
Loss from operations     (11,871,825 )     (5,692,828 )
                 
Other income/(expense), net     13,354       (14,103 )
                 
Net loss   $ (11,858,471 )   $ (5,706,931 )
                 
Dividend to preferred shareholders     (608,343 )     -  
                 
Convertible preferred stock beneficial conversion feature accreted as a deemed dividend     -       (4,393,809 )
                 
Inducement charge from exercise of warrants     (16,741,356 )     -  
                 
Net loss attributable to common shareholders   $ (29,208,170 )   $ (10,100,740 )
                 
Net loss available for common shareholders per share - basic and diluted   $ (0.33 )   $ (0.18 )
                 
Weighted average common shares outstanding: basic and diluted     89,468,153       57,505,788  
                 
             
Matinas BioPharma Holdings Inc.
Consolidated Balance Sheets
Unaudited
             
    September 30, 2017     December 31, 2016  
    (Unaudited)     (Audited)  
ASSETS                
                 
CURRENT ASSETS                
                 
Cash and cash equivalents   $ 9,000,674     $ 4,105,451  
Restricted cash     155,404       155,610  
Prepaid expenses     1,017,372       304,427  
Total current assets     10,173,450       4,565,488  
                 
Leasehold improvements and equipment - net     1,460,455       356,143  
In-process research and development     3,017,377       3,017,377  
Goodwill     1,336,488       1,336,488  
Other assets including long term security deposit     535,999       540,845  
                 
TOTAL ASSETS   $ 16,523,769     $ 9,816,341  
                 
LIABILITIES AND STOCKHOLDERS’ EQUITY                
                 
CURRENT LIABILITIES                
                 
Accounts payable   $ 341,593     $ 475,602  
Note payable     297,912       118,046  
Accrued expenses     753,760       829,724  
Deferred revenue     74,844       -  
Deferred rent liability     395,620       11,485  
Lease liability     19,020       9,936  
Total current liabilities     1,882,749       1,444,793  
                 
LONG TERM LIABILITIES                
                 
Deferred tax liability     1,205,141       1,205,141  
Lease liability - net of current portion     47,914       16,446  
Stock dividends payable - long term     603,143       -  
                 
TOTAL LIABILITIES     3,738,947       2,666,380  
                 
STOCKHOLDERS’ EQUITY                
                 
Series A Convertible preferred stock, stated value $5.00 per share, 1,600,000 shares authorized as of September 30, 2017 and December 31, 2016; 1,507,858 and 1,600,000 shares issued and outstanding as of September 30, 2017 and December 31, 2016, respectively, (liquidation preference - $8,142,433 at September 30, 2017)     5,735,845       6,086,350  
Common stock par value $0.0001 per share, 250,000,000 and 250,000,000 shares authorized at September 30, 2017 and December 31, 2016, respectively; 92,950,096 issued and outstanding as of September 30, 2017; 58,159,495 issued and outstanding as of December 31, 2016     9,294       5,817  
                 
Additional paid in capital     54,686,207       36,237,504  
                 
Accumulated deficit     (47,646,524 )     (35,179,710 )
                 
Total stockholders’ equity     12,784,822       7,149,961  
                 
TOTAL LIABILITIES AND STOCKHOLDERS’ EQUITY   $  16,523,769     $  9,816,341