What changed in this filing

/stocks — the workspaceLOADING

Item 2. Management’s Discussion and Analysis

2024-11-13 compared with 2024-08-14 · 128 added, 125 removed, 172 unchanged (60% of the section changed)

26 unchanged sentences

These factors include, but are not limited to:

our possible retention of an advisor to assist with a potential transaction

involving MAT2203 and the evaluation of other alternatives including but not limited to winddown and dissolution of the Company;

our reduction by 80% of our workforce and the cessation of all product

development activities;

ability to raise additional capital to fund our operations and to develop our product candidates;

23 unchanged sentences

and projections relating to our competitors or our industry;

operations, business and financial results could be adversely impacted by global instability caused by armed conflicts, pandemics

and geo-political uncertainty;

factors listed under the heading “Risk Factors” in our Annual Report on Form 10-K for the year ended December 31, 2023,

10 unchanged sentences

or projections will result or be achieved or accomplished.

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

elements of our strategy include:

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.

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.

elements of our strategy included:

MAT2203 into the ORALTO trial for the treatment of invasive aspergillosis in patients with limited treatment options by securing

10 unchanged sentences

for their complex small molecules and small oligonucleotides, including ASOs and siRNAs.

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.

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

2 unchanged sentences

Operations Overview

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

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.

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.

and Development Expenses

9 unchanged sentences

expenses, including salaries and stock-based compensation expense for those employees involved in the research and development process.

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.

Three months ended June 30,

Six months ended June 30,

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

Three months ended

September 30,

Nine months ended

September 30,

Direct research and development expenses:

12 unchanged sentences

and Administrative Expenses

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.

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.

income, net is largely comprised of interest income/(expense) and dividends.

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.

of Critical Accounting Policies and Accounting Estimates

13 unchanged sentences

Operating Trends

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.

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.

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.

and we plan to continue these investments to be in a position to realize the potential of our product candidates and proprietary technologies.

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.

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.

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.

of Operations

of the three months ended June 30, 2024 to the three months ended June 30, 2023

of the three months ended September 30, 2024 to the three months ended September 30, 2023

following tables summarize our revenues and operating expenses for the periods presented:

Three Months Ended June 30,

Three Months Ended September 30,

Research and development

1 unchanged sentence

Operating Expenses

During the three months ended June 30, 2024 and 2023, we did not generate any revenue.

During the three months ended September 30, 2024 and 2023, we did not generate any revenue.

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.

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.

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.

of the six months ended June 30, 2024 to the six months ended June 30, 2023

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.

of the nine months ended September 30, 2024 to the nine months ended September 30, 2023

following tables summarize our revenues and operating expenses for the periods presented:

Six Months Ended June 30,

Nine Months Ended September 30,

Research and development

1 unchanged sentence

Operating Expenses

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.

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.

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.

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.

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.

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

and capital resources

have funded our operations since inception primarily through private placements and public offerings of our equity securities.

June 30, 2024, we have raised a total of $166,907 in gross proceeds and $153,445, net, from sales of our equity securities.

of June 30, 2024, we had unrestricted cash, cash equivalents and marketable debt securities totaling $14,313.

September 30, 2024, we have raised a total of $166,907 in gross proceeds and $153,445, net, from sales of our equity securities.

of September 30, 2024, we had unrestricted cash, cash equivalents and marketable debt securities totaling $10,795.

Registered Direct Offering

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.

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.

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.

following table sets forth the primary sources and uses of cash, cash equivalents and restricted cash for each of the periods set forth

Six Months Ended June 30,

Nine Months Ended September 30,

Cash used in operating activities

Cash (used in)/provided by investing activities

Cash provided by investing activities

Cash provided by/(used in) financing activities

Net (decrease)/increase in cash and cash equivalents and restricted cash

cash used in operating activities was $8,875 and $6,280 for the six month periods ended June 30, 2024 and 2023, respectively.

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

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.

cash provided by/(used in) financing activities was $9,242 and ($5) for the six month periods ended June 30, 2024 and 2023, respectively.

Net increase/(decrease) in cash and cash equivalents and restricted cash

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.

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.

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

1 unchanged sentence

Requirements and Other Liquidity Matters

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:

further preclinical and clinical studies of MAT2203, our lead product candidate, even if such studies are financed with non-dilutive

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:

further preclinical and clinical studies of MAT2203, our lead product candidate;

to discover and develop additional product candidates;

9 unchanged sentences

doubt exists about the Company’s ability to continue as a going concern.

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.

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.

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.

we raise additional funds through collaborations, strategic alliances or marketing, distribution, or licensing arrangements with third

16 unchanged sentences

Compared sentence by sentence after normalising whitespace, quotation marks, case and digits, so re-formatting and restated figures do not read as changed language. Wording changes appear as one removal and one addition. The current filing and the prior one are authoritative.

What changed 10-Q

Item 2. Management’s Discussion and Analysis