Matinas BioPharma Holdings Inc
For the period ended Sep 30, 2024. Filed Nov 13, 2024.
View on SEC.govAbout this filing
A company's report for each of its first three quarters. The financial statements are not audited. It shows how the business has moved since the last annual report, and what management says changed.
Sep 30, 2024 · Filed Nov 13, 2024
MTNB$1.19+2.6%Stored close · as of Nov 6, 2026
What changed in Management’s Discussion and Analysis?
Read the current filingPrevious report: 10-Q
Period ended 2024-06-30; filed 2024-08-14.
0001493152-24-032144
Item 2. MANAGEMENT’S DISCUSSION AND ANALYSIS OF FINANCIAL CONDITION AND RESULTS OF OPERATIONSCurrent report: 10-Q
Period ended 2024-09-30; filed 2024-11-13.
0001493152-24-045201
Item 2. MANAGEMENT’S DISCUSSION AND ANALYSIS OF FINANCIAL CONDITION AND RESULTS OF OPERATIONSThe baseline is this issuer’s latest earlier reporting period of the same form that was filed before the current report. A previous 10-Q is a different quarter, not a year-over-year comparison. Amendments are excluded.
Compared 63 previous paragraphs and 64 current paragraphs.
41 unchanged; 19 reworded; 4 added; 3 removed; 0 previous and 0 current paragraphs rearranged.
Tables are not compared: 10 previous and 10 current tables excluded. Dates, whitespace, punctuation and numbering changes are ignored; changes to financial figures remain significant.
A changed paragraph is not evidence that risk increased or decreased. An unchanged paragraph does not establish that risk stayed the same.
Added paragraphs (4)
Current report
Reverse Stock Split
Current report
On August 30, 2024, we effected a 1-for-50 reverse stock split of our issued and outstanding common stock (the “Reverse Stock Split”). As a result of the Reverse Stock Split, each of our stockholders received one share of our common stock for every 50 shares such stockholder held immediately prior to the effective time of the Reverse Stock Split. Unless otherwise noted, all shares of common stock, common stock per share data and shares of common stock underlying stock-based awards and warrants convertible into shares of common stock included in these condensed consolidated financial statements, including the exercise or conversion price of such equity instruments, as applicable, have been retroactively adjusted to reflect the Reverse Stock Split for all periods presented.
Current report
In October 2024, we announced implementation of an 80% workforce reduction (the “October RIF”) and ceased all product development activities to conserve cash. We may retain an advisor to assist us with a potential transaction involving MAT2203, and will evaluate other alternatives including but not limited to winddown and dissolution of the company. While this evaluation is ongoing, we expect our R&D expenses will be limited to costs associated with supporting the Company’s MAT2203 Compassionate/Expanded Use Access Program and other costs necessary to maintain compliance with certain regulatory requirements.
Current report
We expect to continue to incur administrative expenses and operating losses as we seek a potential transaction involving MAT2203, and continue to evaluate other alternatives including but not limited to winddown and dissolution of the company. We anticipate that our expenses will increase substantially if we secure additional funding allowing us to resume product development activities and:
Removed paragraphs (3)
Previous report
We expect that most of our R&D expenses in the near-term future will be incurred in support of our current and future preclinical and clinical development programs. These expenditures are subject to numerous uncertainties relating to timing and cost to completion. We test compounds in numerous preclinical studies for safety, toxicology, and efficacy. At the appropriate time, subject to the approval of regulatory authorities, we expect to conduct early-stage clinical trials. We anticipate funding these trials ourselves, and possibly with the assistance of federal grants, contracts, or other agreements. As we obtain results from trials, we may elect to discontinue or delay clinical trials for certain products to focus our resources on more promising products. Completion of clinical trials may take several years, and the length of time varies substantially according to the type, complexity, novelty and intended use of a product candidate.
Previous report
The commencement and completion of clinical trials for our products may be delayed by many factors, including lack of efficacy during clinical trials, unforeseen safety issues, slower than expected participant recruitment, lack of funding or government delays. In addition, we may encounter regulatory delays or rejections as a result of many factors, including results that do not support the intended safety or efficacy of our product candidates, perceived defects in the design of clinical trials and changes in regulatory policy during the period of product development. As a result of these risks and uncertainties, we are unable to accurately estimate the specific timing and costs of our clinical development programs or the timing of material cash inflows, if any, from our product candidates. Our business, financial condition and results of operations may be materially adversely affected by any delays in, or termination of, our clinical trials or a determination by the FDA that the results of our trials are inadequate to justify regulatory approval, insofar as cash in-flows from the relevant drug or program would be delayed or would not occur.
Previous report
We expect to continue to incur significant expenses and increasing operating losses for the foreseeable future. We anticipate that our expenses will increase substantially if and as we:
Reworded paragraphs (19)
Previous wording
We are a clinical-stage biopharmaceutical company focused on delivering groundbreaking therapies using our lipid nanocrystal (LNC) platform delivery technology (LNC Platform). We are seeking to develop an internal pipeline of products utilizing the LNC Platform to successfully encapsulate small molecules and small oligonucleotides and facilitate targeted and extrahepatic delivery to desired cell tissues without toxicity.
Current wording
We are a clinical-stage biopharmaceutical company. In October 2024, we announced that negotiations under a previously disclosed non-binding term sheet regarding global rights to our MAT2203 (oral amphotericin B) product candidate have been terminated following notification from the prospective partner. As a result, we implemented an 80% workforce reduction and ceased all product development activities to conserve cash. We may retain an advisor to assist us with a potential transaction involving MAT2203, and will evaluate other alternatives including but not limited to winddown and dissolution of the company. Prior to ceasing product development activities, we were focused on delivering groundbreaking therapies using our lipid nanocrystal (LNC) platform delivery technology (LNC Platform) and sought to develop an internal pipeline of products utilizing the LNC Platform to successfully encapsulate small molecules and small oligonucleotides and facilitate targeted and extrahepatic delivery to desired cell tissues without toxicity.
Previous wording
Key elements of our strategy include:
Current wording
Key elements of our strategy included:
Previous wording
For the six month periods ended June 30, 2024 and 2023, our net loss was $11,543 and $11,573, respectively. We have incurred losses for each period from our inception and expect to incur additional losses for the foreseeable future. We do not believe the cash, cash equivalents and marketable debt securities on hand are sufficient to fund planned operations beyond the next twelve months from the filing date of these financial statements. We seek to fund our operations through public or private equity offerings, debt financing, government or other third-party funding, collaborations and licensing arrangements. These financing alternatives may not be available to us on acceptable terms, or at all. As a result, substantial doubt exists about our ability to continue as a going concern.
Current wording
For the nine month periods ended September 30, 2024 and 2023, our net loss was $15,818 and $17,628, respectively. We have incurred losses for each period from our inception and expect to incur additional losses for the foreseeable future. We do not believe the cash, cash equivalents and marketable debt securities on hand are sufficient to fund planned operations beyond the next twelve months from the filing date of these financial statements. We seek to fund our operations through public or private equity offerings, debt financing, government or other third-party funding, collaborations and licensing arrangements. These financing alternatives may not be available to us on acceptable terms, or at all. As a result, substantial doubt exists about our ability to continue as a going concern.
Previous wording
During the three and six months ended June 30, 2024, we did not generate any revenue. During the three and six months ended June 30, 2023, we generated $0 and $1,096, respectively, in contract research revenue resulting from the research collaborations with BioNTech SE and Genentech Inc. Our ability to generate product revenue, which we do not expect to occur for many years, if ever, will depend heavily on the successful development and eventual commercialization of our early-stage product candidates.
Current wording
During the three and nine months ended September 30, 2024, we did not generate any revenue. During the three and nine months ended September 30, 2023, we generated $0 and $1,096, respectively, in contract research revenue resulting from the research collaborations with BioNTech SE and Genentech Inc. Our ability to generate product revenue, which we do not expect to occur for many years, if ever, will depend heavily on the successful development and eventual commercialization of our early-stage product candidates.
Previous wording
The table below summarizes our direct research and development expenses for our product candidates and development platform for the three and six months ended June 30, 2024 and 2023. Our direct research and development expenses consist principally of external costs, such as fees paid to contractors, consultants, analytical laboratories and CROs and/or the NIH, in connection with our development work. We typically use our employee and infrastructure resources for manufacturing clinical trial materials, conducting product analysis, study protocol development and overseeing outside vendors. Included in “Internal staffing, overhead and other” below is the cost of laboratory space, supplies, research and development (R&D) employee costs (including stock-based compensation), travel and medical education.
Current wording
The table below summarizes our direct research and development expenses for our product candidates and development platform for the three and nine months ended September 30, 2024 and 2023. Our direct research and development expenses consist principally of external costs, such as fees paid to contractors, consultants, analytical laboratories and CROs and/or the NIH, in connection with our development work. We typically use our employee and infrastructure resources for manufacturing clinical trial materials, conducting product analysis, study protocol development and overseeing outside vendors. Included in “Internal staffing, overhead and other” below is the cost of laboratory space, supplies, research and development (R&D) employee costs (including stock-based compensation), travel and medical education.
Previous wording
General and administrative expense for the three and six months ended June 30, 2024 were $2,468 and $4,925, respectively, and the three and six months ended June 30, 2023 were $2,600 and $5,311, respectively. General and administrative expenses consist principally of salaries and related costs for personnel in executive and finance functions. Other general and administrative expenses include facility costs, insurance, investor relations expenses, professional fees for legal, patent review, consulting and accounting/audit services. We anticipate that our general and administrative expenses during 2024 will decrease slightly compared to expenses incurred during 2023.
Current wording
General and administrative expense for the three and nine months ended September 30, 2024 were $2,142 and $7,067, respectively, and the three and nine months ended September 30, 2023 were $2,839 and $8,151, respectively. General and administrative expenses consist principally of salaries and related costs for personnel in executive and finance functions. Other general and administrative expenses include facility costs, insurance, investor relations expenses, professional fees for legal, patent review, consulting and accounting/audit services. We anticipate that our general and administrative expenses during 2024 will decrease slightly compared to expenses incurred during 2023.
Previous wording
Our current R&D efforts are focused on advancing our lead LNC product candidate, MAT2203, through clinical development toward an initial indication for the treatment of CM and expanding application of our LNC Platform through both internal efforts and collaborations with third parties. Our R&D expenses consist of manufacturing work and the cost of active pharmaceutical ingredients and excipients used in such work, fees paid to consultants for work related to clinical trial design and regulatory activities, fees paid to providers for conducting various clinical studies as well as for the analysis of the results of such studies, and for other medical research addressing the potential efficacy and safety of our drugs. We believe that significant investment in product development is a competitive necessity, and we plan to continue these investments to be in a position to realize the potential of our product candidates and proprietary technologies.
Current wording
Prior to the October RIF, our R&D efforts had been focused on advancing our lead LNC product candidate, MAT2203, through clinical development toward an initial indication for the treatment of CM and expanding application of our LNC Platform through both internal efforts and collaborations with third parties. Our R&D expenses consisted of manufacturing work and the cost of active pharmaceutical ingredients and excipients used in such work, fees paid to consultants for work related to clinical trial design and regulatory activities, fees paid to providers for conducting various clinical studies as well as for the analysis of the results of such studies, and for other medical research addressing the potential efficacy and safety of our drugs. We believe that significant investment in product development is a competitive necessity.
Previous wording
Research and Development expenses. Research and Development (R&D) expense for the three months ended June 30, 2024 and 2023 was $3,371 and $3,559, respectively. The decrease in R&D expense was primarily attributable to lower stock based compensation expense.
Current wording
Research and Development expenses. Research and Development (R&D) expense for the three months ended September 30, 2024 and 2023 was $2,239 and $3,295, respectively. The decrease in R&D expense was primarily attributable to lower headcount related expenses, and lower manufacturing and clinical trial expenses.
Previous wording
General and Administrative expenses. General and Administrative (G&A) expense for the three months ended June 30, 2024 and 2023 was $2,468 and $2,600, respectively. The decrease in G&A expense was primarily attributable to lower stock based compensation expense and decreased insurance premiums.
Current wording
General and Administrative expenses. General and Administrative (G&A) expense for the three months ended September 30, 2024 and 2023 was $2,142 and $2,839, respectively. The decrease in G&A expense was primarily attributable to lower consulting fees and lower headcount related expenses.
Previous wording
Comparison of the six months ended June 30, 2024 to the six months ended June 30, 2023
Current wording
Comparison of the nine months ended September 30, 2024 to the nine months ended September 30, 2023
Previous wording
***Revenues.***During the six month periods ended June 30, 2024 and 2023, we generated revenue of $0 and $1,096. The amount earned during the prior year consists of contract research revenue resulting from the research collaboration with BioNTech SE and Genentech Inc.
Current wording
***Revenues.***During the nine month periods ended September 30, 2024 and 2023, we generated revenue of $0 and $1,096. The amount earned during the prior year consists of contract research revenue resulting from the research collaboration with BioNTech SE and Genentech Inc.
Previous wording
Research and Development expenses. R&D expense for the six month periods ended June 30, 2024 and 2023 was $6,817 and $7,530, respectively. The decrease in R&D expense was primarily attributable to lower stock based compensation expense, a decrease in other payroll related costs due to decreased headcount and the decrease in clinical trial costs.
Current wording
Research and Development expenses. R&D expense for the nine month periods ended September 30, 2024 and 2023 was $9,057 and $10,824, respectively. The decrease in R&D expense was primarily attributable to lower stock based compensation expense, a decrease in other payroll related costs due to decreased headcount and the decrease in manufacturing and clinical trial expenses.
Previous wording
General and Administrative expenses. G&A for the six month periods ended June 30, 2024 and 2023 was $4,925 and $5,311, respectively. The decrease in G&A expense was primarily attributable to lower stock based compensation expense and decreased insurance premiums.
Current wording
General and Administrative expenses. G&A for the nine month periods ended September 30, 2024 and 2023 was $7,067 and $8,151, respectively. The decrease in G&A expense was primarily attributable to lower stock based compensation expense, consulting fees and decreased insurance premiums.
Previous wording
As of June 30, 2024, we had unrestricted cash, cash equivalents and marketable debt securities totaling $14,313.
Current wording
As of September 30, 2024, we had unrestricted cash, cash equivalents and marketable debt securities totaling $10,795.
Previous wording
On April 5, 2024, the Company closed a registered direct offering of 33,333,334 shares of its common stock and warrants to purchase up to an aggregate of 33,333,334 additional shares of common stock, at a combined purchase price of $0.30 per share and accompanying warrant. The Company generated gross proceeds of approximately $10,000 and net proceeds of approximately $9,190, after deducting underwriting discounts and commissions and other offering expenses.
Current wording
On April 5, 2024, the Company closed a registered direct offering of 666,667 shares of its common stock and warrants to purchase up to an aggregate of 666,667 additional shares of common stock, at a combined purchase price of $15.00 per share and accompanying warrant. The Company generated gross proceeds of approximately $10,000 and net proceeds of approximately $9,190, after deducting underwriting discounts and commissions and other offering expenses.
Previous wording
Net cash used in operating activities was $8,875 and $6,280 for the six month periods ended June 30, 2024 and 2023, respectively. Net losses of $11,543 and $11,573 for the six month periods ended June 30, 2024 and 2023, respectively, were partially offset by working capital adjustments due to the timing of receipts and payments in the ordinary course of business and adjustments for non-cash stock based compensation expense.
Current wording
Net cash used in operating activities was $12,375 and $10,699 for the nine month periods ended September 30, 2024 and 2023, respectively. Net losses of $15,818 and $17,628 for the nine month periods ended September 30, 2024 and 2023, respectively, were partially offset by working capital adjustments due to the timing of receipts and payments in the ordinary course of business and adjustments for non-cash stock based compensation expense.
Previous wording
Net cash (used in)/provided by investing activities was ($938) and $9,198 for the six month periods ended June 30, 2024 and 2023, respectively. The increase of cash used in investing activities was primarily due to a $7,938 purchase of marketable securities and a $2,400 decrease in maturities of marketable debt securities partially offset by a $202 decrease in the purchases of leasehold improvements and equipment.
Current wording
Net cash provided by investing activities was $8,708 and $10,282 for the nine month periods ended September 30, 2024 and 2023, respectively. The decrease of cash used in investing activities was primarily due to a $8,437 purchase of marketable securities offset by a $6,645 increase in maturities of marketable debt securities and a $218 decrease in the purchases of leasehold improvements and equipment.
Previous wording
Net cash provided by/(used in) financing activities was $9,242 and ($5) for the six month periods ended June 30, 2024 and 2023, respectively. The increase in cash provided by financing activities is primarily due to the net proceeds received from the sale of our common stock in the registered direct offering, $9,190, and the net proceeds received from the sale of our common stock under the ATM with BTIG, LLC, $54.
Current wording
Net cash provided by/(used in) financing activities was $9,175 and ($6) for the nine month periods ended September 30, 2024 and 2023, respectively. The increase in cash provided by financing activities is primarily due to the net proceeds received from the sale of our common stock in the registered direct offering, $9,125, and the net proceeds received from the sale of our common stock under the ATM with BTIG, LLC, $54.
Previous wording
Until such time, if ever, that we can generate product revenues sufficient to achieve profitability, we expect to finance our cash needs through a combination of private and public equity offerings, debt financings, government or other third-party funding, collaborations, and licensing arrangements. To the extent that we raise additional capital through the sale of common stock, convertible securities or other equity securities, the ownership interest of our stockholders may be materially diluted, and the terms of these securities may include liquidation or other preferences that adversely affect your rights of our common stockholders. Debt financing and preferred equity financing, if available, would result in increased fixed payment obligations and may involve agreements that include covenants limiting or restricting our ability to take specific actions, such as incurring additional debt, making capital expenditures, or declaring dividends, that could adversely impact our ability to conduct our business. Securing additional financing could require a substantial amount of time and attention from our management and may divert a disproportionate amount of their attention away from day-to-day activities, which may adversely affect our management’s ability to oversee the development of our product candidates.
Current wording
Until such time, if ever, that we can generate product revenues sufficient to achieve profitability, we would expect to finance our cash needs through a combination of private and public equity offerings, debt financings, government or other third-party funding, collaborations, and licensing arrangements. To the extent that we raise additional capital through the sale of common stock, convertible securities or other equity securities, the ownership interest of our stockholders may be materially diluted, and the terms of these securities may include liquidation or other preferences that adversely affect your rights of our common stockholders. Debt financing and preferred equity financing, if available, would result in increased fixed payment obligations and may involve agreements that include covenants limiting or restricting our ability to take specific actions, such as incurring additional debt, making capital expenditures, or declaring dividends, that could adversely impact our ability to conduct our business. Securing additional financing could require a substantial amount of time and attention from our management and may divert a disproportionate amount of their attention away from day-to-day activities, which may adversely affect our management’s ability to oversee the development of our product candidates.