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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): March 9, 2026
Acurx Pharmaceuticals, Inc.
(Exact name of registrant as specified in its
charter)
| Delaware | |
001-40536 | |
82-3733567 |
(State or other jurisdiction
of incorporation) | |
(Commission
File Number) | |
(IRS
Employer
Identification No.) |
259 Liberty Avenue, Staten Island, NY 10305
(Address of principal executive offices) (Zip
Code)
Registrant’s telephone number, including
area code: (917) 533-1469
Not applicable
(Former name 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:
| ¨ |
Written communications pursuant to Rule 425 under the Securities Act (17 CFR 230.425) |
| ¨ |
Soliciting material pursuant to Rule 14a-12 under the Exchange Act (17 CFR 240.14a-12) |
| ¨ |
Pre-commencement communications pursuant to Rule 14d-2(b) under the Exchange Act (17 CFR 240.14d-2(b)) |
| ¨ |
Pre-commencement 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 of each class |
|
Trading
Symbol |
|
Name of each exchange
on which registered |
| Common Stock, par value $0.001 per share |
|
ACXP |
|
The Nasdaq Stock Market LLC |
Indicate by check mark whether the registrant is an emerging growth
company as defined in Rule 405 of the Securities Act of 1933 (§230.405 of this chapter) or Rule 12b-2 of the Securities Exchange
Act of 1934 (§240.12b-2 of this chapter).
Emerging
growth company x
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.
Item 5.02 Departure of Directors or Certain
Officers; Election of Directors; Appointment of Certain Officers; Compensatory Arrangements of Certain Officers.
On March 9, 2026, the Compensation Committee
of the Board of Directors (the “Compensation Committee”) of Acurx Pharmaceuticals, Inc. (the “Company”) approved,
and the executive officers listed below voluntarily agreed to, reductions to their base salaries (the “Salary Reductions”)
as part of broader leadership compensation alignment measures. The Compensation Committee also approved a 10% reduction to the cash components
of the Company’s non-employee director compensation program, including annual cash retainers for Board service and additional cash
retainers for the Chair of the Board and for committee chairs and members (the “Director Cash Reductions”).
Under the Salary Reductions, effective as of April
1, 2026, the base salaries of the following executives will be:
| Executive |
Title |
Annual Base Salary After 10% Reduction |
| David P. Luci |
President and Chief Executive Officer |
$495,000 |
| Robert J. DeLuccia |
Executive Chairman |
$495,000 |
| Robert G. Shawah |
Chief Financial Officer |
$360,000 |
The Salary Reductions are being implemented on
a fully voluntary basis at the request of the executives and were approved by the Compensation Committee following its review of market
conditions and the Company’s operating plan. The Salary Reductions do not modify the terms of any executive’s employment agreement
other than with respect to base salary. Unless otherwise determined by the Compensation Committee, (i) target bonus opportunities under
the Company’s annual incentive plan will continue to be expressed as a percentage of base salary as in effect from time to time
and (ii) long-term equity incentive awards will not be impacted by the Salary Reductions. The Salary Reductions will not constitute “good
reason” or a similar constructive termination event under any applicable employment agreement or compensatory plan.
The Director Cash Reductions will become effective
as of April 1, 2026. The Company’s non-employee director compensation program is described under Executive Officer and Director
Compensation— Director Compensation in the Company’s 2025 10-K filed with the Securities and Exchange Commission on March
17, 2025, which description is incorporated herein by reference. The Director Cash Reductions apply to the cash retainers described in
that section, including the annual cash retainer for Board service and the additional cash retainers for the Chair of the Board and for
committee chairs and committee members. Except as described herein, the equity components of the non-employee director compensation program
remain unchanged.
Item 8.01 Other Events.
On March 9, 2026, the Company announced a
new clinical development initiative to expand the ibezapolstat program into recurrent C. difficile infection (rCDI). The initiative includes
an open-label pilot trial in multiply-recurrent CDI that will enroll up to 20 patients who have experienced at least two recurrences within
the past 12 months. Trial start-up activities are scheduled to begin later this month, and first-patient enrollment is expected in
the fourth quarter of this year. The Company intends to use data from this 20-patient study to inform the design of a planned active-controlled
Phase 3 registration trial in rCDI. Following a successful pivotal Phase 3 study, the Company plans to seek the United States
Food and Drug Administration’s approval under the Limited Population Pathway for Antibacterial and Antifungal Drugs (LPAD) for treatment
and prevention of rCDI.
A copy of the press release is filed as Exhibit
99.1 to this Current Report on Form 8-K and is incorporated by reference into this Item 8.01.
Forward-Looking Statements
This Current Report on Form 8-K contains forward-looking
statements within the meaning of the Private Securities Litigation Reform Act of 1995. Forward-looking statements include, but are not
limited to, statements regarding: the expected duration of, and the Company's plans and expectations with respect to, the Salary Reductions
and the Director Cash Reductions; the Company's planned clinical development initiative to expand the ibezapolstat program into rCDI,
including the design, timing, and enrollment of the open-label pilot trial and the planned Phase 3 registration trial; anticipated trial
start-up activities and expected first-patient enrollment timelines; and the Company's intention to seek approval from the United States
Food and Drug Administration under the Limited Population Pathway for Antibacterial and Antifungal Drugs (LPAD) for treatment and prevention
of rCDI. These forward-looking statements are based on the Company's current expectations, estimates, and projections about future events
and involve known and unknown risks and uncertainties that could cause actual results to differ materially from those expressed or implied
by such statements. Important factors that could cause actual results to differ materially include, without limitation, risks related
to the Company's ability to achieve the anticipated benefits of the Salary Reductions and Director Cash Reductions, the Company's ability
to initiate and complete clinical trials on expected timelines, the uncertainty of clinical trial results, the Company's ability to obtain
regulatory approvals, competition, general economic and market conditions, and the other risk factors described in the Company's filings
with the Securities and Exchange Commission, including the Company's most recent Annual Report on Form 10-K and subsequent filings. The
Company undertakes no obligation to publicly update or revise any forward-looking statements, whether as a result of new information,
future events, or otherwise, except as required by applicable law
Item 9.01 Financial Statements and Exhibits.
(d) Exhibits.
The following exhibits are
filed with this Current Report on Form 8-K:
Exhibit
No. |
|
Description |
| 99.1 |
|
Press Release |
| 104 |
|
Cover Page Interactive Data File - the cover page XBRL tags are embedded within the Inline XBRL document |
Signatures
Pursuant to the requirements of the Securities
Exchange Act of 1934, the registrant has duly caused this report to be signed by the undersigned hereunto duly authorized.
| |
Acurx Pharmaceuticals, Inc. |
| Date: March 9, 2026 |
|
|
| |
By: |
/s/ David P. Luci |
| |
Name: |
David P. Luci |
| |
Title: |
President and Chief Executive Officer |
Exhibit 99.1
Acurx
Announces New Ibezapolstat Clinical Trial Program in Patients with Recurrent CDI That Has the Potential to Shift the Paradigm
of
Treatment and Prevention of C. difficile Infection
Acurx’s
Program in the Broader CDI Patient Population is Ready to Advance to
Phase 3 International Clinical Trials
| · | Acurx
is launching a ground-breaking clinical trial with ibezapolstat in patients with multiply-recurrent
CDI (rCDI) that has the potential to shift the paradigm of treatment and prevention of rCDI
from two agents to one |
| · | When
coupled with IBZ Phase 2 results of being highly effective (96% clinical cure of 26 patients)
in treating acute CDI with no recurrence in patients while sparing the gut microbiome, this
new trial will position IBZ as a candidate to be the first agent to demonstrate clinical
success in both the treatment of CDI and the prevention of rCDI |
| · | In
a Phase 2 trial, all 25 patients treated with IBZ who experienced a clinical cure of CDI
were free of recurrence 1 month after treatment and 5 of 5 (100%) of these patients who were
observed for 3 months after treatment remained free of recurrence |
| · | Recent
unpublished data from Dr. Kevin Garey’s laboratory at the University of Houston demonstrate
that beneficial bacterial taxa persist in fecal samples from patients with rCDI despite multiple
prior CDI treatments with the antibiotic standards of care, vancomycin and/or fidaxomicin,
indicating that, following acute treatment with IBZ, these beneficial microorganisms will
have the opportunity to repopulate the microbiome in a favorable way that may prevent recurrence
|
| · | Trial
start-up activities for this new clinical trial in rCDI will initiate later this month with
the first patient expected to enroll in the fourth quarter this year. This open-label trial
will enroll up to 20 patients whose CDI has recurred at least twice following standard of
care antibiotic treatment within the past 12 months. |
| · | Acurx
has previously been granted FDA QIDP and Fast-Track Designation and has received SME (Small
and Medium-sized Enterprise) designation by the EMA |
STATEN ISLAND, N.Y.,
March 9, 2026 /PRNewswire/Acurx Pharmaceuticals, Inc. (Nasdaq ACXP) ("Acurx" or the "Company"), a clinical
stage biopharmaceutical company developing a new class of antibiotics for difficult-to-treat bacterial infections, today announced
that it will conduct a new clinical trial in patients with recurrent C. difficile Infection (rCDI) while its program in the
broader CDI patient population is ready to advance to Phase 3 international clinical trials, subject to receiving appropriate
funding. This new clinical trial in rCDI begins with an open-label pilot trial to gain experience with IBZ in patients with
multiply-recurrent CDI with at least 3 episodes of CDI within the past 12 months. This will inform elements of a planned
active-controlled, Phase 3 registration trial in the rCDI indication to be implemented following favorable results from the
open-label 20 patient trial. Upon subsequent successful completion of the Ph3 pivotal rCDI trial, and per the operative FDA
procedure, Acurx plans to request FDA approval for treatment and prevention of rCDI under the FDA’s Limited Population Pathway
for Antibacterial and Antifungal Drugs (Guidance for Industry, 2020). Results of the above-mentioned experimental data from the
University of Houston laboratory of Dr. Kevin Garey, has been submitted in abstract form to the Anaerobe Society of the Americas
scientific conference July 7-10, 2026, at Columbia University in New York and will be publicly disclosed shortly
thereafter.
More
details about this new program will be discussed on the company’s March 13, 2026 earnings call for full year and fourth quarter
2025 financial results on Friday, March 13, 2026 at 8:00 am ET (Toll-Free (U.S.): 877-790-1503 Access ID: 13758852).
Click here for participant International Toll-Free access numbers.
Members of the Acurx R&D team will be available on the earnings call to
answer questions from stockholders or other interested parties.
Robert J. DeLuccia,
Executive Chairman of Acurx, stated "Ibezapolstat has been demonstrated in Phase 2 to be highly effective in both curing CDI and
in preventing recurrence. We believe ibezapolstat has the potential to be the first agent to demonstrate clinical success in both the
treatment of CDI and the prevention of rCDI, and such success would shift the paradigm of treatment and prevention of rCDI from two agents
to one. This would be a game changer to the public health threat that affects approximately 500,000 patients with CDI each year in the
U.S., results in approximately 30,000 deaths, and generates a related public health cost burden of approximately $5 billion, of which
$2.8 billion is related to rCDI.”
He further stated: “We’re
also very excited about the FDA’s recent announcement published in the New England Journal of Medicine ‘…that a one-trial
requirement will be FDA’s new default standard for registration’. If formalized, this would end the long-standing two-trial
dogma. We look forward to FDA’s further clarification and the potentially favorable implications to our clinical development programs,
such as the opportunity to seek marketing approval for the broader CDI population with one pivotal clinical trial. This would of course
have favorable effects for our stockholders and, very importantly, CDI patients in need.”
For
recent publications regarding above, please see our website: www.acurxpharma.com
Makary, NEJM, Feb2026;
WK Smits, Nature Communications, Nov2025; Lancet Microbe, June 2025
About
rCDI (Recurrent C. difficile Infection)
In recent studies, rCDI
ranges from 4 to 19.5% following treatment with fidaxomicin and 17 to 27% following treatment with vancomycin. In patients with multiple
prior episodes of CDI, rCDI following treatment with vancomycin is even more problematic, with an incidence of up to 40%. Consequently,
the principal unmet medical need in this disease is the prevention of recurrence. The estimated annual public health cost burden in the
U.S. annually is ~$5 billion annually with ~$2.8 billion due to recurrent CDI.
Acurx
previously announced that it had received positive regulatory guidance from the EMA during its Scientific Advice Procedure which confirmed
that the clinical, non-clinical and CMC (Chemistry Manufacturing and Controls) information package submitted to EMA supports advancement
of the ibezapolstat Phase 3 program and if the Phase 3 program is successful, supports the submission of a Marketing Authorization Application
(MAA) for regulatory approval in Europe. The information package submitted to EMA by the Company to which agreement has been reached
with EMA included details on Acurx's two planned international Phase 3 clinical trials, 1:1 randomized (designed as non-inferiority vs
vancomycin), primary and secondary endpoints, sample size, statistical analysis plan and the overall registration safety database. With
mutually consistent feedback from both EMA and FDA, Acurx is well positioned to commence our international Phase 3 registration program.
The primary efficacy analysis
will be performed using a Modified Intent-To-Treat (mITT) population. This will result in an estimated 450 subjects in the mITT population,
randomized in a 1:1 ratio to either ibezapolstat or standard- of-care vancomycin, enrolled into the initial Phase 3 trial. The trial
design not only allows determination of ibezapolstat's ability to achieve Clinical Cure of CDI as measured 2 days after 10 days of oral
treatment but also includes assessment of ibezapolstat's potential effect on reduction of CDI recurrence in the target population. In
the event non-inferiority of ibezapolstat to vancomycin is demonstrated, further analysis will be conducted to test for superiority.
About the Ibezapolstat
Phase 2 Clinical Trial
The completed multicenter,
open-label single-arm segment (Phase 2a) study was followed by a double-blind, randomized, active-controlled, non-inferiority, segment
(Phase 2b) at 28 US clinical trial sites which together comprise the Phase 2 clinical trial. This Phase 2 clinical trial was designed
to evaluate the clinical efficacy of ibezapolstat in the treatment of CDI including pharmacokinetics and microbiome changes from baseline.
from study centers in the United States. In the Phase 2a trial segment,10 patients with diarrhea caused by C. difficile were treated
with ibezapolstat 450 mg orally, twice daily for 10 days. All patients were followed for recurrence for 28± 2 days. Per protocol,
after 10 patients of the projected 20 Phase 2a patients completed treatment (100% cured infection at End of Treatment (10 of 10).
In the Phase 2b trial
segment, 32 patients with CDI were enrolled and randomized in a 1:1 ratio to either ibezapolstat 450 mg every 12 hours or vancomycin
125 mg orally every 6 hours, in each case, for 10 days and followed for 28 ± 2 days following the end of treatment for recurrence
of CDI. The two treatments were identical in appearance, dosing times, and number of capsules administered to maintain the blind. In
this Phase 2b trial segment, 15 out of 16 (94%) patients in Phase 2b in the Per Protocol Population experienced Clinical Cure (CC) and
all 15 of 15 (100%) remained free of C. difficile infection (CDI) recurrence through one month after EOT.
When Phase 2b results are
combined with Phase 2a results, the Clinical Cure rate in patients with CDI was 96% (25 out of 26 patients), based on 10 out of 10 patients
(100%) in Phase 2a in the Modified Intent to Treat Population, plus 15 out of 16 (94%) patients in Phase 2b in the Per Protocol Population,
who experienced Clinical Cure during treatment with ibezapolstat. Notably, in the combined Phase 2 trial, 100% (25 of 25) ibezapolstat-treated
patients) who had Clinical Cure at EOT) (End of Treatment) remained cured through one month after EOT, as compared to 86% (12 of 14)
for the vancomycin patient group.
Ibezapolstat was well-tolerated,
with no serious adverse events assessed by the blinded investigator to be drug- related. The Company is confident that based on the pooled
Phase 2 ibezapolstat Clinical Cure rate of 96%, Sustained Clinical Cure Rate of 100% and the historical vancomycin Clinical Cure Rate
range of 70% to 92% and a Sustained Clinical Cure historical range of 42% to 74%, we will demonstrate non-inferiority of ibezapolstat
to vancomycin in Phase 3 trials, in accordance with the applicable FDA Guidance for Industry (October 2022), with favorable differentiation
in both Clinical Cure and Sustained Clinical Cure.
In the Phase 2 clinical
trial (both trial segments), the Company also evaluated pharmacokinetics (PK) and microbiome changes and test for anti-recurrence microbiome
properties, including the change from baseline in alpha diversity and bacterial abundance, especially overgrowth of healthy gut microbiota
Actinobacteria and Firmicute phylum species during and after therapy. Phase 2a data demonstrated complete eradication of colonic C. difficile
by day three of treatment with ibezapolstat as well as the observed overgrowth of healthy gut microbiota, Actinobacteria and Firmicute
phyla species, during and after therapy. Very importantly, emerging data show an increased concentration of secondary bile acids during
and following ibezapolstat therapy which is known to correlate with colonization resistance against C. difficile. A decrease in primary
bile acids and the favorable increase in the ratio of secondary-to-primary bile acids suggest that ibezapolstat may reduce the likelihood
of CDI recurrence when compared to vancomycin. The company also reported positive extended clinical cure (ECC) data for ibezapolstat
(IBZ), its lead antibiotic candidate, from the Company's recently completed Phase 2b clinical trial in patients with CDI. This exploratory
endpoint showed that 5 of 5 IBZ patients followed for up to three months following Clinical Cure experienced no recurrence of infection.
Furthermore, ibezapolstat-treated patients showed lower concentrations of fecal primary bile acids, and higher beneficial ratio of secondary
to primary bile acids than vancomycin-treated patients.
About Ibezapolstat
Ibezapolstat is the Company's
lead antibiotic candidate planning to advance to international Phase 3 clinical trials to treat patients with C. difficile infection.
Ibezapolstat is a novel, orally administered antibiotic, being developed as a Gram-Positive Selective Spectrum (GPSS®) antibacterial.
It is the first of a new class of DNA polymerase IIIC inhibitors under development by Acurx to treat bacterial infections. Ibezapolstat's
unique spectrum of activity, which includes C. difficile but spares other Firmicutes and the important Actinobacteria phyla, appears
to contribute to the maintenance of a healthy gut microbiome.
In June 2018, ibezapolstat
was designated by the U.S. Food an Drug Administration (FDA) as a Qualified Infectious Disease Product (QIDP) for the treatment of patients
with CDI and will be eligible to benefit from the incentives for the development of new antibiotics established under the Generating
New Antibiotic Incentives Now (GAIN) Act. In 2019, FDA granted "Fast Track" designation to ibezapolstat for the treatment of
patients with CDI. The CDC has designated C. difficile as an urgent threat highlighting the need for new antibiotics to treat
CDI.
About Clostridioides difficile
Infection
According
to the 2017 Update (published February 2018) of the Clinical Practice Guidelines for C. difficile Infection by the Infectious
Diseases Society of America (IDSA) and Society or Healthcare Epidemiology of America (SHEA), CDI remains a significant medical
problem in hospitals, in long-term care facilities and in the community. C. difficile is one of the most common causes of
health care- associated infections in U.S. hospitals (Lessa, 2015, NEJM). Recent estimates suggest C. difficile approaches
500,000 infections annually in the U.S. and is associated with approximately 20,000 deaths annually. (Guh, 2020, NEJM. Based on
internal estimates, the recurrence rate for the antibiotics currently used to treat CDI is between 20% and 40% among approximately
150,000 patients treated. We believe the annual incidence of CDI in the U.S. approaches 600,000 infections and a mortality rate of
approximately 9.3%.
About the Microbiome in
C. difficile Infection and Bile Acid Metabolism
C. difficile can
be a normal component of the healthy gut microbiome, but when the microbiome is thrown out of balance, the C. difficile can thrive
and cause an infection. After colonization with C. difficile, the organism produces and releases the main virulence factors, the
two large clostridial toxins A (TcdA) and B (TcdB). (Kachrimanidou, Microorganisms 2020.) TcdA and TcdB are exotoxins that bind to human
intestinal epithelial cells and are responsible for inflammation, fluid and mucous secretion, as well as damage to the intestinal mucosa.
Bile acids perform many functional roles in the GI tract, with one of the most important being maintenance of a healthy microbiome by
inhibiting C. difficile growth. Primary bile acids, which are secreted by the liver into the intestines, promote germination of
C. difficile spores and thereby increase the risk of recurrent CDI after successful treatment of an initial episode. On the other
hand, secondary bile acids, which are produced by normal gut microbiota through metabolism of primary bile acids, do not induce C.
difficile sporulation and therefore protect against recurrent disease. Since ibezapolstat treatment leads to minimal disruption of
the gut microbiome, bacterial production of secondary bile acids continues which may contribute to an anti-recurrence effect. Beneficial
effects of bile acids include a decrease in primary bile acids and an increase in secondary bile acids in patients with CDI, which was
observed in the Company's Ph2a trial results and previously reported (Garey, CID, 2022). In the Ph2b trial, ibezapolstat-treated patients
showed lower concentrations of fecal primary bile acids, and higher beneficial ratio of secondary to primary bile acids than vancomycin-treated
patients.
About Acurx Pharmaceuticals,
Inc.
Acurx
Pharmaceuticals is a late-stage biopharmaceutical company focused on developing a new class of small molecule antibiotics for difficult-to-treat
bacterial infections. The Company's approach is to develop antibiotic candidates with a Gram-positive selective spectrum (GPSS®)
that blocks the active site of the Gram-positive specific bacterial enzyme DNA polymerase IIIC (pol IIIC), inhibiting DNA replication
and leading to Gram-positive bacterial cell death. Its R&D pipeline includes antibiotic product candidates that target Gram-positive
bacteria, including Clostridioides difficile, methicillin- resistant Staphylococcus aureus (MRSA), vancomycin resistant
Enterococcus (VRE), drug- resistant Streptococcus pneumoniae (DRSP) and B. anthracis (anthrax; a Bioterrorism Category A Threat-Level
pathogen). Acurx's lead product candidate, ibezapolstat, for the treatment of C. difficile Infection is Phase 3 ready with plans
in progress to begin international clinical trials. The Company's preclinical pipeline includes development of an oral product candidate
for treatment of ABSSSI (Acute Bacterial Skin and Skin Structure Infections), upon which a development program for treatment of inhaled
anthrax is being planned in parallel. To learn more about Acurx Pharmaceuticals and its product pipeline, please visit www.acurxpharma.com.
Forward-Looking Statements
Any statements in this
press release about our future expectations, plans and prospects, including statements regarding our strategy, future operations, prospects,
plans and objectives, and other statements containing the words "believes," "anticipates," "plans," "expects,"
and similar expressions, constitute forward-looking statements within the meaning of The Private Securities Litigation Reform Act of
1995. Actual results may differ materially from those indicated by such forward-looking statements as a result of various important factors,
including: whether ibezapolstat will benefit from the QIDP designation; whether ibezapolstat will advance through the clinical trial
process on a timely basis; whether the results of the clinical trials of ibezapolstat will warrant the submission of applications for
marketing approval, and if so, whether ibezapolstat will receive approval from the FDA or equivalent foreign regulatory agencies where
approval is sought; whether, if ibezapolstat obtains approval, it will be successfully distributed and marketed; and other risks and
uncertainties described in the Company's annual report filed with the Securities and Exchange Commission on Form 10-K for the year ended
December 31, 2024, and in the Company's subsequent filings with the Securities and Exchange Commission. Such forward-looking statements
speak only as of the date of this press release, and Acurx disclaims any intent or obligation to update these forward-looking statements
to reflect events or circumstances after the date of such statements, except as may be required by law.
Investor Contact:
Acurx Pharmaceuticals,
Inc.;
David P. Luci, President
& CEO
Tel: 917-533-1469;
Email:
davidluci@acurxpharma.com
