Current Report Filing (8-k)
July 13 2022 - 09:29AM
Edgar (US Regulatory)
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2022-07-13 iso4217:USD xbrli:shares iso4217:USD xbrli:shares
UNITED STATES
SECURITIES AND EXCHANGE COMMISSION
WASHINGTON, DC 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): July 13, 2022
(July
13, 2022)
PLURISTEM THERAPEUTICS INC.
(Exact Name of Registrant as Specified in Its Charter)
Nevada |
|
001-31392 |
|
98-0351734 |
(State or Other Jurisdiction
of Incorporation) |
|
(Commission File Number) |
|
(IRS Employer
Identification No.) |
MATAM Advanced Technology Park |
|
|
Building
No. 5 |
|
|
Haifa,
Israel |
|
3508409 |
(Address of Principal Executive
Offices) |
|
(Zip Code) |
011 972
74 710 7171
(Registrant’s telephone number, including area code)
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(s) |
|
Name of each exchange on which
registered |
Common Stock, par value $0.00001 per share |
|
PSTI |
|
The
Nasdaq Global Market |
Indicate by check mark whether the registrant is an emerging growth
company as defined in 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
☐
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 8.01. Other Events.
On July 13, 2022, Pluristem Therapeutics Inc., or the registrant,
announced topline results from its Phase III Study of muscle
regeneration following hip fracture surgery. The registrant
designed the study to determine the efficacy, safety, and
tolerability of intramuscular administration of allogeneic PLX-PAD
cells for the treatment of muscle injury following arthroplasty for
hip fracture.
PLX-PAD was demonstrated to be an effective accelerator of muscle
strength and regeneration. A significant increase in Hip Abduction
Strength, or HAS, was observed at week 26 and week 52 for patients
treated with PLX-PAD (n=120) in the injured leg (p=0.047, p=0.0022)
and uninjured leg (p=0.073, p=0.0046) compared to placebo (n=120).
This new data confirms the results demonstrated in the registrant’s
phase I/II study. The study did not meet the primary endpoint,
which was the Short Physical Performance Battery test, or SPPB, at
week 26. The SPPB is a series of physical performance tests used in
older persons to assess lower extremity function and mobility.
PLX-PAD was well tolerated and demonstrated a significant increase
in HAS. In the injured leg (i) patients treated with PLX-PAD cells
showed an increase of 3.2kg from reference (week 6) to week 26
compared to 1.3kg in the placebo group, a 2kg difference (p=0.047);
and (ii) patients treated with PLX-PAD cells showed an increase of
5.01kg from reference (week 6) to week 52 compared to 0.86kg in the
placebo group, a 4kg difference (p=0.0022). In the uninjured leg
(i) patients treated with PLX-PAD cells showed an increase of 2.3kg
from reference (week 6) to week 26 compared to 0.51kg in the
placebo group, a 1.8kg difference (p=0.073); and (ii) patients
treated with PLX-PAD cells showed an increase of 3.3kg from
reference (week 6) to week 52 compared to a decrease of 0.7kg in
the placebo group, a 4kg difference, (p=0.0046).
When comparing the absolute HAS between study groups (treated
versus placebo) at week 52, patients treated with PLX-PAD showed a
2.6kg higher score than placebo treated patients in the injured leg
(p=0.0511). A similar benefit was seen in the uninjured leg, with a
2.2kg difference (p=0.113).
The increase in HAS was further supported by a positive trend in a
6-minute walk test at week 52, showing an increase in walking
distance. PLX-PAD treated patients (n=36) were able to walk 296
meters versus only 266 meters in placebo treated patients (n=45).
The 6-minute walk test evaluates the global and integrated
responses of all the systems involved in walking (pulmonary,
cardiovascular, systemic and peripheral circulation,
musculoskeletal function, neuromuscular units, and muscle
metabolism), and is an acceptable functional endpoint.
The registrant intends to seek further regulatory advice to find a
way to bridge the gap between the impact on muscle strength and the
functionality score as observed in the study. In addition, the
registrant intends to explore business opportunities and
partnerships to advance the development of its PLX-PAD product
candidate.
Warning Concerning Forward Looking Statements
This Current Report on Form 8-K contains forward-looking statements
within the meaning of the “safe harbor” provisions of the Private
Securities Litigation Reform Act of 1995 and federal securities
laws. For example, forward-looking statements are being used when
the registrant discusses that it intends to seek further regulatory
advice to find a way to bridge the gap between the impact on muscle
strength and the functionality score as observed in the study and
that it intends to explore business opportunities and partnerships
to advance the development of its PLX-PAD product candidate. These
forward-looking statements and their implications are based on the
current expectations of the management of the registrant only, and
are subject to a number of factors and uncertainties that could
cause actual results to differ materially from those described in
the forward-looking statements. The following factors, among
others, could cause actual results to differ materially from those
described in the forward-looking statements: changes in technology
and market requirements; the registrant may encounter delays or
obstacles in launching and/or successfully completing its clinical
trials; the registrant’s products may not be approved by regulatory
agencies, the registrant’s technology may not be validated as it
progresses further and its methods may not be accepted by the
scientific community; the registrant may be unable to retain or
attract key employees whose knowledge is essential to the
development of our products; unforeseen scientific difficulties may
develop with our process; the registrant’s products may wind up
being more expensive than the registrant anticipates; results in
the laboratory may not translate to equally good results in real
surgical settings; results of preclinical studies may not correlate
with the results of human clinical trials; the registrant’s patents
may not be sufficient; the registrant’s products may harm
recipients; changes in legislation; inability to timely develop and
introduce new technologies, products and applications; loss of
market share and pressure on pricing resulting from competition,
which could cause the actual results or performance of the
registrant to differ materially from those contemplated in such
forward-looking statements. In addition, historic results of
scientific research do not guarantee that the conclusions of future
research would not suggest different conclusions or that historic
results would not be interpreted differently in light of additional
research or otherwise. Except as otherwise required by law, the
registrant undertakes no obligation to publicly release any
revisions to these forward-looking statements to reflect events or
circumstances after the date hereof or to reflect the occurrence of
unanticipated events. For a more detailed description of the risks
and uncertainties affecting the registrant, reference is made to
the registrant’s reports filed from time to time with the
Securities and Exchange Commission.
SIGNATURES
Pursuant to the requirements of the Securities Exchange Act of
1934, the Registrant has duly caused this report to be signed on
its behalf by the undersigned hereunto duly authorized.
|
PLURISTEM
THERAPEUTICS INC. |
|
|
|
|
By: |
/s/ Chen Franco-Yehuda |
|
Name: |
Chen Franco-Yehuda |
|
Title: |
Chief Financial
Officer |
Date: July 13, 2022
2
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