LABT 10-K & 10-Q changes, risk factors and insider trading
Lakewood-Amedex Biotherapeutics Inc. · Nasdaq · Pharmaceutical Preparations · CIK 2079272 · All filings on SEC.gov
At a glance
What changed in the latest 10-K
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What changed in the latest 10-Q
Risk Factors
Not required because we are a smaller reporting company.
No wording changes found in this section.
Full comparison: every changed paragraph (0)
Management's Discussion & Analysis (MD&A)
New heading “Recent Developments”
New heading “Series C Financing”
New heading “Reverse Stock Split”
New heading “Advancement of Clinical Development”
New heading “Strengthened Financial Position”
New heading “Comparison of the six months ended June 30, 2026 and 2025”
New heading “Research and development expenses”
New heading “General and administrative expenses”
New heading “Other income (expense), net”
New heading “For the six months ended June 30, 2026 and 2025”
New heading “Investing Activities”
New heading “Operating Lease”
New heading “Public Company Costs”
Removed heading “Sources of Liquidity”
Removed heading “For the three months ended March 31, 2026 and 2025”
Largest changes
“We have incurred significant operating losses and negative cash flows from operations since our inception. Our net losses were $0.9 million and $0.5 million for the three months ended March 31, 2026 and 2025, respectively. As of March 31, 2026, we had an accumulated deficit of $54.3 million. Substantially all our net losses have resulted from costs incurred in connection with our R&D programs and, to a lesser extent, from general and administrative (“G&A”) costs associated with our operations. …”see in full comparison
Full comparison: every changed paragraph (84)
Lakewood-Amedex Biotherapeutics Inc. is a clinical-stage biotechnology company focused on the development of novel antimicrobial therapeutics for the treatment of serious infectious diseases, including infections caused by antibiotic-resistant bacteria. The Company’s lead product candidate, Nu-3 (Bisphosphocin® gel formulation), is being developed as a topical antimicrobial therapy for the treatment of iDFU. The Company is currently advancing preparations for a Phase 2a dose-comparison clinical study while continuing to develop its broader antimicrobial technology platform.
The three months ended June 30, 2026 represented a significant milestone in the Company’s evolution. During the quarter, the Company completed a private placement of its Series C Convertible Preferred Stock, generating approximately $7.5 million in gross proceeds, completed the listing of its common stock on the Nasdaq Capital Market, and substantially simplified its capital structure through the conversion of its outstanding preferred stock and convertible debt into common stock. These transactions significantly strengthened the Company’s balance sheet, enhanced its liquidity, and positioned the Company to advance its clinical development strategy.
Following the financing and Nasdaq listing, management’s primary focus shifted from capital formation to execution of the Company’s clinical development objectives. During the quarter, the Company expanded activities supporting its planned Phase 2a clinical study, including manufacturing, regulatory, and clinical planning activities necessary to advance Nu-3 toward its next stage of development. As a result, research and development expenses increased compared to the prior-year period. General and administrative expenses also increased significantly, primarily reflecting stock-based compensation, professional fees, advisory services, investor relations activities, legal and accounting costs, and other expenses associated with becoming a Nasdaq-listed public company.
The Company has incurred recurring operating losses since inception and expects to continue incurring losses as it advances the clinical development of Nu-3 and its other product candidates. While the capital raised during the quarter significantly improved the Company’s liquidity and provides financial resources to execute its near-term operating plans, the Company expects that additional capital will be required to complete clinical development, pursue regulatory approvals, and support commercialization activities. Management intends to continue evaluating a variety of financing alternatives to support the Company’s long-term strategic objectives.
Recent Developments
Series C Financing
On April 21, 2026, the Company completed a private placement of its Series C Convertible Preferred Stock, raising approximately $6.8 million in net proceeds. The financing significantly strengthened the Company’s capital resources and provided funding to support the advancement of its clinical development programs, including preparations for the planned Phase 2a clinical study of Nu-3 in iDFU. The financing also enabled the Company to satisfy key conditions necessary for its subsequent listing on the Nasdaq Capital Market.
Nasdaq Listing
On April 23, 2026, the Company’s common stock commenced trading on the Nasdaq Capital Market. Management believes the Nasdaq listing represents a significant milestone in the Company’s development by increasing its visibility within the investment community, broadening access to the public capital markets, and enhancing its ability to pursue future financing opportunities to support its long-term growth strategy.
We are a clinical-stage biopharmaceutical company focused on leveraging
unique, pioneering science to address unmet needs in the treatment of infectious diseases, improving patient outcomes, and significantly
reducing the threat posed by antibiotic-resistant bacterial strains, including methicillin resistant Staphylococcus aureus (MRSA),
vancomycin resistant Enterococci species (VRE), and others. Antimicrobial resistance (AMR) represents a growing global health crisis,
being directly responsible for 1.27 million deaths annually and contributing to nearly 5 million deaths worldwide. The rapid rise of resistant
pathogens has rendered many existing antibiotics ineffective against these pathogens, increasing the risk of severe infections, prolonged
hospital stays, and substantial economic burdens. Despite this urgent need, the development of new antibiotics has slowed, with most advancements
occurring within existing drug classes, leaving these new compounds vulnerable to resistance mechanisms.
Our product candidates consist of antimicrobials targeting acute and
chronic infectious diseases, which are delivered locally to the site of infection. As of April 2026, we hold 68 issued and 36 pending
patent applications for our products and technologies, with coverage in major pharmaceutical markets. We have successfully completed our
first exploratory human clinical trials for our lead product, the broad-spectrum Bisphosphocin® (anti-bacterial) Nu-3,
which is being developed for the topical treatment of mildly infected diabetic foot ulcers (iDFU). We plan to conduct an initial Phase
2a safety and dose response study, followed by a placebo-controlled Phase 2b dose comparative study to identify the optimal dose for Phase
3 trials and eventual commercialization. This study will also determine the most appropriate administration regimen for Nu-3 gel formation
in mildly infected diabetic foot ulcers. Additionally, we are advancing early-stage pipeline compounds and are focused on further characterizing
them to identify the best clinical indications for non-clinical and clinical evaluation. Advancement of any of our product candidates
to the commercialization stage is completely dependent on the outcome of clinical studies that are reviewed and approved by the FDA or
other comparable regulatory authorities.
CorporateSimplification Historyof andCapital Structure
In connection with the Nasdaq listing, all outstanding shares of the Company’s Series A and Series B Convertible Preferred Stock, together with the Company’s outstanding convertible promissory notes and related accrued interest, automatically converted into shares of common stock pursuant to their respective terms. These conversions significantly simplified the Company’s capital structure by eliminating multiple classes of convertible securities and reducing future financing complexity.
Reverse Stock Split
On June 19, 2026, the Company effected a one-for-ten reverse stock split of its issued and outstanding common stock. The reverse stock split was implemented to satisfy the capital structure requirements associated with the Company’s financing transactions and Nasdaq listing. All share and per-share amounts presented in this Quarterly Report have been retroactively adjusted to give effect to the reverse stock split.
Advancement of Clinical Development
Following completion of the financing and Nasdaq listing, the Company accelerated activities supporting the advancement of Nu-3 (Bisphosphocin® gel formulation) toward its planned Phase 2a clinical study. During the quarter, the Company continued manufacturing, regulatory, and clinical planning activities and entered into agreements with third-party service providers to support future clinical development. These activities contributed to the increase in research and development expenditures during the quarter as the Company transitioned from financing activities to execution of its clinical development strategy.
Strengthened Financial Position
As a result of the financing transactions completed during the quarter, the Company substantially improved its liquidity and working capital position. At June 30, 2026, the Company held cash, cash equivalents, and certificates of deposit sufficient to support its near-term operating objectives of less than 12 months. Although management believes the Company’s current capital resources will enable it to continue advancing its clinical development plans, the Company expects that additional financing will ultimately be required to complete the development of its product candidates, obtain regulatory approvals, and support future commercialization activities.
Headquartered in University Park, Florida, we were originally incorporated
in Delaware on July 11, 2006, under the name Nu Pharmas, Inc. (“Nu Pharmas”). We initially focused on antisense RNA research
and the contract manufacturing of oligonucleotides. On April 9, 2007, Nu Pharmas acquired substantially all the assets of Renaissance
Nutraceuticals, Inc., a Delaware corporation, and subsequently changed its name to Amedex Therapeutics, Inc. (“Amedex Therapeutics”).
On November 11, 2007, Amedex Therapeutics acquired substantially all the assets of Lakewood Pharmaceuticals, Inc., a Delaware corporation.
On February 1, 2008, Amedex Therapeutics changed its name to Lakewood-Amedex Inc. On June 5, 2025, the Company changed its name to Lakewood-Amedex
Biotherapeutics Inc. and redomiciled as a Nevada corporation. On September 29, 2025, the Company filed a certificate of amendment to its
articles of incorporation effecting a 1-for-5.92 reverse stock split.
From 2012 to 2013, we shifted our focus toward the development of small
molecule antimicrobials, particularly the Bisphosphocin® class of molecules, which were discovered during the early oligonucleotide
testing. Since 2014, we have continued to refine our research and development efforts to address the growing global issue of AMR.
We have incurred significant operating losses and negative cash flows
from operations since our inception. Our net losses were $0.9 million and $0.5 million for the three months ended March 31, 2026
and 2025, respectively. As of March 31, 2026, we had an accumulated deficit of $54.3 million. Substantially all our net losses have
resulted from costs incurred in connection with our R&D programs and, to a lesser extent, from general and administrative (“G&A”)
costs associated with our operations. Our net losses may fluctuate significantly from quarter-to-quarter and year-to-year, depending on
the timing of our clinical trials, preclinical studies, and our other R&D activities. In addition, we incur additional costs associated
with operating as a public company, including significant legal, audit, accounting, regulatory and tax-related services associated with
maintaining compliance with exchange listing and requirements of the Securities and Exchange Commission (“SEC”), director
and officer liability insurance costs, investor and public relations costs, and other expenses.
Because of the numerous risks and uncertainties associated with the
development of therapeutics, we are unable to accurately predict the timing or amount of increased expenses and when, or if, we will be
able to achieve or maintain profitability. Even if we are able to generate product sales, we may not become profitable. If we fail to
become profitable or are unable to sustain profitability on a continuing basis, then we may be unable to continue our operations as planned
and may be forced to reduce or terminate our operations.
We do not have any products approved for sale and have not generated
any revenue from product sales. We will not generate revenue from product sales unless and until we successfully complete clinical development
and obtain regulatory approval for our current or any future product candidates, which we expect will take a number of years or may
never occur. As a result, we will need substantial additional funding to support our continuing operations and pursue our growth strategy.
Until such time as we can generate significant revenue from product sales, if ever, we expect to finance our operations through equity
offerings, debt financings, or other capital sources, including current and potential future collaborations, license agreements, and other
similar arrangements. However, we may be unable to raise additional funds or enter into such other agreements or arrangements when needed
on favorable terms, or at all. If we fail to raise capital or enter into such agreements or arrangements as, and when needed, we may delay,
limit, reduce or terminate our product development or future commercialization efforts or grant rights to develop and market product candidates
that we would otherwise develop and market ourselves, or even cease operations.
As of March 31, 2026, we had cash and cash equivalents of $11.7
thousand. In addition, on April 21, 2026, we received net proceeds of approximately $6.8 million from a private placement of Series C
Convertible Preferred Stock. Based on our current operating plan, we estimate that our cash and cash equivalents will be sufficient to
fund our operating expenses requirements through 2026. However, we have based this estimate on assumptions that may prove to be wrong,
and we could deplete our capital resources sooner than we currently expect.
Comparison of the three months ended MarchJune 31,30, 2026 and
2025
The following table summarizes our results of operations for the three months
ended MarchJune 31,30, 2026 and 2025:
The following table summarizes our R&D expenses for the three months
ended MarchJune 31,30, 2026 and 2025:
Research and development expenses increased approximately $356 thousand, or 242%, to $503 thousand for the three months ended June 30, 2026, compared to $147 thousand for the comparable period in 2025.
Personnel-related expenses increased approximately $128 thousand, primarily reflecting increased compensation and stock-based compensation as the Company expanded activities to support its clinical development programs and the partial restoration of previously reduced executive compensation. The increase in clinical and pre-clinical expenses was primarily attributable to a $225 thousand increase expenses associated with manufacturing, regulatory, and other activities supporting the Company’s planned Phase 2a clinical study of Nu-3 in iDFU, which had previously been put on hold while the Company completed its financing and Nasdaq listing. Other research and development expenses remained relatively consistent with the prior-year period.
Research and development expenses were $182 thousand for the three months
ended March 31, 2026, compared to $170 thousand for the three months ended March 31, 2025. The increase of $12 thousand in
research and development expenses was primarily attributable to a increase of approximately $20 thousand in workforce-related expenses,
including the partial restoration of previously voluntary reduced compensation. The increase was partially offset by: (i) the promotion
of our Chief Operating Officer to Chief Executive Officer, which resulted in the prospective change in allocation of 60% of such executive’s
salary to general and administrative expenses; (ii) a decrease of approximately $13 thousand in stock-based compensation expense; and
(iii) a decrease of approximately $8 thousand in clinical and regulatory expenses related to a clinical trial.
The following table summarizes our general and administrative expenses
for the three months ended MarchJune 31,30, 2026 and 2025:
General and administrative expenses increased approximately $2.8 million, or 571%, to $3.3 million for the three months ended June 30, 2026, compared to $489 thousand for the comparable period in 2025.
The increase was primarily attributable to approximately $2.6 million increase in professional services, principally reflecting approximately $2.4 million of noncash professional service expense recognized in connection with the issuance of common stock for placement agent advisory services. The remaining increase in professional services primarily reflects higher Nasdaq listing and compliance costs, patent-related legal fees, audit and accounting fees, and other professional fees associated with the Company’s transition to operating as a Nasdaq-listed public company.
Personnel-related expenses increased approximately $127 thousand, primarily reflecting increased stock-based compensation and compensation, including changes in executive compensation allocations and the partial restoration of previously reduced executive compensation. Corporate expenses increased approximately $116 thousand, primarily due to higher directors’ and officers’ insurance premiums, investor relations activities, and other public company operating costs. Facility costs remained substantially consistent with the prior-year period.
General and administrative expenses were approximately $703 thousand
for the three months ended March 31, 2026 compared to approximately $372 thousand for the three months ended March 31,
2025. The increase of approximately $331 thousand was primarily attributable: (i) an increase of approximately $75 thousand in workforce-related
expenses, including the partial restoration of voluntary reduced compensation, the promotion of our Chief Operating Officer to Chief Executive
Officer resulting in the prospective change in allocation of such executive’s salary to general and administrative expenses, and
increased stock-based compensation expense; (ii) an increase of approximately $219 thousand in professional fees; and (iii) an increase
of approximately $37 thousand in investor relations and public relations expenses. The increases in professional fees and investor relations-related
expenses were primarily incurred in connection with the Company’s preparation for a proposed direct listing on Nasdaq.
Other income, net was approximately $18 thousand for the three months ended June 30, 2026, compared to other expense, net of approximately $19 thousand for the comparable period in 2025, representing a favorable change of approximately $36 thousand.
The improvement was primarily attributable to approximately $23 thousand increase in interest income resulting from higher average cash balances following completion of the Company’s Series C financing, together with approximately $13 thousand decrease in interest expense resulting from the automatic conversion of the Company’s outstanding convertible promissory notes into common stock upon the Company’s Nasdaq listing. As a result, the Company generated net other income during the 2026 period compared with net other expense during the comparable prior-year period.
Comparison of the six months ended June 30, 2026 and 2025
The following table summarizes our results of operations for the six months ended June 30, 2026 and 2025:
Research and development expenses
The following table summarizes our R&D expenses for the six months ended June 30, 2026 and 2025:
Research and development expenses increased approximately $369 thousand, or 116%, to $685 thousand for the six months ended June 30, 2026, compared to approximately $317 thousand for the comparable period in 2025.
Personnel-related expenses increased approximately $148 thousand, primarily due to increased compensation and stock-based compensation associated with expanded research and development activities and the partial restoration of previously reduced executive compensation. The clinical and pre-clinical expenses increase primarily reflects approximately $217 thousand increase in expenses associated with manufacturing, regulatory, and clinical development activities supporting the Company’s planned Phase 2a clinical study of Nu-3 in iDFU, which had previously been put on hold while the company completed its financing and Nasdaq listing. Other research and development expenses remained substantially consistent with the prior-year period.
General and administrative expenses
The following table summarizes our general and administrative expenses for the six months ended June 30, 2026 and 2025:
General and administrative expenses increased approximately $3.1 million, or 363%, to approximately $4.0 million for the six months ended June 30, 2026, compared to approximately $861 thousand for the comparable period in 2025.
The increase was primarily attributable to approximately $2.8 million increase in professional services, principally reflecting approximately $2.4 million of noncash professional service expense recognized in connection with the issuance of common stock for placement agent advisory services. The remaining increase in professional services primarily reflects higher Nasdaq listing and compliance costs, patent-related legal fees, audit and accounting fees, and other professional fees associated with the Company’s transition to operating as a Nasdaq-listed public company and compliance with its ongoing SEC reporting obligations.
Personnel-related expenses increased approximately $202 thousand, primarily reflecting higher stock-based compensation and compensation, including changes in executive compensation allocations. Corporate expenses increased approximately $148 thousand, primarily due to increased directors’ and officers’ insurance, investor relations activities, Nasdaq listing fees, and other public company operating costs. Facility costs remained substantially unchanged from the comparable prior-year period.
Other income (expense), net
Other expense, net was approximately $19 thousand for the six months ended June 30, 2026, compared to approximately $16 thousand for the comparable period in 2025.
Interest income increased approximately $20 thousand as a result of higher average cash balances following completion of the Series C financing. Interest expense increased approximately $24 thousand, primarily reflecting interest incurred on convertible promissory notes outstanding prior to their automatic conversion into common stock upon the Company’s Nasdaq listing.
Other income (expense), net was approximately $(37) thousand for the
three months ended March 31, 2026 compared to approximately $3 thousand for the three months ended March 31, 2025.
The decrease of approximately $40 thousand was primarily attributable to: an increase in interest expense of approximately $37 thousand
related to the issuance of convertible notes and short-term notes to provide additional working capital and support the Company’s
proposed direct listing on Nasdaq; and (ii) a decrease in interest income of approximately $3 thousand.
Since inception, the Company has financed its operations primarily through the issuance of equity securities and convertible debt. The Company has incurred recurring operating losses and negative cash flows from operations as it has advanced the development of its product candidates. At June 30, 2026, the Company had $2.6 million in cash and cash equivalents, $2.0 million in certificates of deposit, and working capital of approximately $4.2 million, compared to $236 thousand in cash and cash equivalents and a working capital deficit of approximately $2.1 million at December 31, 2025.
The significant improvement in the Company’s liquidity and financial position during the six months ended June 30, 2026 was primarily attributable to the completion of its Series C Convertible Preferred Stock financing, which generated net proceeds of approximately $6.8 million. In addition, the automatic conversion of the Company’s outstanding Series A and Series B Convertible Preferred Stock and convertible promissory notes into common stock in connection with the Nasdaq listing significantly reduced current liabilities and simplified the Company’s capital structure.
The Company continues to invest in the advancement of Nu-3 (Bisphosphocin® gel formulation), including manufacturing, regulatory, and clinical development activities supporting its planned Phase 2a clinical study. Management believes that the Company’s existing cash, cash equivalents, investments, and anticipated interest income will be sufficient to fund its currently planned operating activities for the foreseeable future of less than 12 months. Nevertheless, because the Company expects to continue incurring operating losses as it advances the clinical development of its product candidates, additional capital will ultimately be required to complete clinical development, obtain regulatory approvals, and support future commercialization activities. Management intends to continue evaluating a variety of financing alternatives, including equity financings, strategic collaborations, licensing arrangements, and other sources of capital to support the Company’s long-term business objectives.
For the six months ended June 30, 2026 and 2025
The following table summarizes our cash flows for the six months ended June 30, 2026 and 2025:
Net cash used in operating activities increased to approximately $2.5 million for the six months ended June 30, 2026 from approximately $913 thousand for the comparable period in 2025. The increase primarily reflects expanded operating activities associated with the Company’s clinical development programs and increased costs incurred in connection with operating as a Nasdaq-listed public company. Cash used in operating activities was partially offset by significant noncash charges, including approximately $2.4 million of noncash professional service expense recognized in connection with the issuance of common stock for placement agent advisory services, as well as stock-based compensation and other noncash expenses.
Investing Activities
LABT insider buying and selling (Form 4)
Since 2026-04-11, insiders reported open-market purchases in 0 Form 4 filings and open-market sales in 0 filings. Totals add up every open-market (code P and S) line in those filings, using the prices reported in the filings. Awards, option exercises, tax withholding and gifts are listed below but not counted.
No Form 4 stock transactions in this period.
Well-known investors holding LABT (13F)
None of the 59 investors we track reported a position in their latest 13F.