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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): July 24, 2024
SONNET
BIOTHERAPEUTICS HOLDINGS, INC.
(Exact
name of registrant as specified in its charter)
Delaware |
|
001-35570 |
|
20-2932652 |
(State
or other jurisdiction
of
incorporation) |
|
(Commission
File
Number) |
|
(IRS
Employer
Identification
No.) |
100
Overlook Center, Suite 102
Princeton,
New Jersey |
|
08540 |
(Address
of principal executive office) |
|
(Zip
Code) |
Registrant’s
telephone number, including area code: (609) 375-2227
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, $0.0001 par value per share |
|
SONN |
|
The
Nasdaq Capital 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 ☐
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
7.01 Regulation FD.
On
July 24, 2024, Sonnet BioTherapeutics Holdings, Inc. (the “Company”) issued a press release announcing data from the Phase
1b portion of its Phase 1b/2a clinical trial of SON-080 in Chemotherapy-Induced Peripheral Neuropathy (“CIPN”)
that support advancement into a Phase 2 study. A copy of the press release is attached hereto as Exhibit 99.1. On July 24, 2024, the
Company also participated in a “Virtual Investor ‘What This Means’ Segment” presentation to further discuss the
Phase 1b data. A copy of the transcript of the presentation
is attached hereto as Exhibit 99.2.
The
information in this Current Report on Form 8-K under Item 7.01, including the information contained in Exhibit 99.1, is being furnished
to the Securities and Exchange Commission (the “SEC”), and shall not be deemed to be “filed” for the purposes
of Section 18 of the Securities Exchange Act of 1934, as amended (the “Exchange Act”), or otherwise subject to the liabilities
of that section, and shall not be deemed to be incorporated by reference into any filing under the Securities Act of 1933, as amended,
or the Exchange Act, except as shall be expressly set forth by a specific reference in such filing.
Item
8.01 Other Events.
On
July 24, 2024, the Company announced data from the Phase 1b portion of its Phase 1b/2a clinical trial of SON-080 in CIPN (the “SB211
study”) that support advancement into a Phase 2 study. The data indicates that SON-080 was
well-tolerated at both doses, with no evidence of a pro-inflammatory cytokine response. Pain and quality of life survey results suggest
the potential for rapid improvement of peripheral neuropathy symptoms and post-dosing durability with both doses, compared to placebo
controls. The Company intends to seek a partnership to support initiation of a Phase 2 clinical trial of SON-080 in Diabetic Peripheral
Neuropathy (“DPN”), a mechanistically synergistic and larger, high-value indication with unmet medical need.
The
SB211 study is a double-blind, randomized, controlled trial of SON-080 conducted at two sites in Australia in patients with persistent
CIPN using a new proprietary version of recombinant human Interleukin-6 (rhIL-6) that builds upon previous work with atexakin alfa. The
goal of the Phase 1b portion of the SB211 study was to confirm safety and tolerability before continued development in Phase 2. As previously
announced in March 2024, a data and safety monitoring board reviewed the unblinded safety and tolerability of SON-080 in the first nine
patients and concluded that the symptoms were tolerable in the initial patients and the study could proceed to Phase 2.
CIPN
is a common side effect of many chemotherapeutic drugs that induce peripheral nerve damage. CIPN can last for weeks to years after treatment
has ended and patients with CIPN often experience discomfort that can result in persistent, unbearable pain, as well as motor and autonomic
dysfunction that may limit the duration of their cancer treatment. Conventional pain medications and opioids are often ineffective against
peripheral neuropathy, creating a significant unmet need for new treatment options. Low dose IL-6 has been shown to stimulate peripheral
nerve growth in preclinical models, thereby ameliorating motor and sensory functions and normalizing the associated pain or sensation
disturbance of neuropathy.
A
total of 9 patients were randomized between two different SON-080 dose groups and placebo in this portion of the study. The treatment
period was 12 weeks long and patients were followed-up for an additional 12 weeks.
The
Phase 1b data demonstrated SON-080 was well-tolerated at both 20 µg and 60 µg/dose, which was about 10-fold lower than the
maximum tolerated dose (MTD) for IL-6 that was established in previous clinical evaluations. Injection site erythema was the most prominent
treatment-related adverse event irrespective of the dose of SON-080, and was transient and mild in all but one case at each dose, where
it was moderate. Fatigue was reported occasionally and was more prominent at the higher dose. One patient who developed severe fatigue
and stopped dosing after one month was in the low-dose group. Headache, dizziness, and chills were reported infrequently in the high-dose
group; all were mild apart from a single moderate event with each symptom. All other adverse events were infrequent and mild.
The
Quality-of-Life Questionnaire-CIPN twenty-item scale (QLQ-CIPN20), a validated survey designed to assess cancer patients’ experience
of symptoms and functional limitations related to CIPN, was used as the primary indicator of response. While the number of patients in
each group was small, a trend toward improved scores within a month of starting therapy was seen for both dose groups as compared to
placebo in the overall scores. This greater improvement with SON-080 persisted after the 12 weeks of therapy had stopped, while the placebo
group scores returned to baseline. These results are in line with the preclinical model insights with low dose IL-6, although further
work with larger clinical groups is needed to substantiate this trend.
Multiple
cytokines were studied as part of the safety evaluation. There was no demonstrable drug effect on any of these inflammatory cytokine
serum levels during or after therapy with SON-080. However, there was a dose-related increase in serum amyloid alpha that persisted during
therapy, which returned to baseline once treatment was stopped. An expert consultant concluded that the degree of amyloid elevation seen
in this study for 12 weeks should be benign.
Forward-Looking
Statements
This
Current Report on Form 8-K contains certain forward-looking statements within the meaning of Section 27A of the Securities Act of 1933
and Section 21E of the Exchange Act and Private Securities Litigation Reform Act, as amended, including those relating to the outcome
of the Company’s clinical trials, the Company’s cash runway, the Company’s product development, clinical and regulatory
timelines, market opportunity, competitive position, possible or assumed future results of operations, business strategies, potential
growth opportunities and other statements that are predictive in nature. These forward-looking statements are based on current expectations,
estimates, forecasts and projections about the industry and markets in which we operate and management’s current beliefs and assumptions.
These
statements may be identified by the use of forward-looking expressions, including, but not limited to, “expect,” “anticipate,”
“intend,” “plan,” “believe,” “estimate,” “potential,” “predict,”
“project,” “should,” “would” and similar expressions and the negatives of those terms. These statements
relate to future events or the Company’s financial performance and involve known and unknown risks, uncertainties, and other factors
which may cause actual results, performance or achievements to be materially different from any future results, performance or achievements
expressed or implied by the forward-looking statements. Such factors include those set forth in the Company’s filings with the
SEC. Prospective investors are cautioned not to place undue reliance on such forward-looking statements, which speak only as of the date
of this Current Report. The Company undertakes no obligation to publicly update any forward-looking statement, whether as a result of
new information, future events or otherwise.
Item
9.01 Financial Statements and Exhibits.
(d)
Exhibits
SIGNATURE
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.
|
SONNET
BIOTHERAPEUTICS HOLDINGS, INC. |
|
|
|
Date:
July 24, 2024 |
By: |
/s/
Pankaj Mohan, Ph.D. |
|
Name: |
Pankaj
Mohan, Ph.D. |
|
Title: |
Chief
Executive Officer |
Exhibit
99.1
Sonnet BioTherapeutics Reports Encouraging Data
from Phase 1b/2a Clinical Trial of SON-080 in Chemotherapy-Induced Peripheral Neuropathy (CIPN) That Support Advancement into Phase 2
Study
● |
Data indicates that SON-080 was well-tolerated at both doses, with no evidence of a pro-inflammatory cytokine response |
● |
Pain and quality of life survey results suggest the potential for rapid improvement of peripheral neuropathy symptoms and post-dosing durability with both doses, compared to placebo controls |
● |
Sonnet intends to seek a partnership to support initiation of a Phase 2 clinical trial of SON-080 in Diabetic Peripheral Neuropathy (DPN), a mechanistically synergistic and larger, high-value indication with unmet medical need |
● |
Management highlights data findings in a Virtual Investor “What This Means” segment |
PRINCETON,
NJ / ACCESSWIRE / July 24, 2024 / Sonnet BioTherapeutics Holdings, Inc. (the “Company” or “Sonnet”) (NASDAQ:SONN),
a clinical-stage company developing targeted immunotherapeutic drugs, today announced encouraging data from the Phase 1b portion of its
Phase 1b/2a clinical trial evaluating SON-080 for the treatment of CIPN (the “SB211 study”). The SB211 study is a double-blind,
randomized, controlled trial of SON-080 conducted at two sites in Australia in patients with persistent CIPN using a new proprietary
version of recombinant human Interleukin-6 (rhIL-6) that builds upon previous work with atexakin alfa. The goal of the Phase 1b portion
of the SB211 study was to confirm safety and tolerability before continued development in Phase 2. As previously announced in March 2024,
a data and safety monitoring board reviewed the unblinded safety and tolerability of SON-080 in the first nine patients and concluded
that the symptoms were tolerable in the initial patients and the study could proceed to Phase 2. Additionally, the Company participated
in a Virtual Investor “What This Means” segment to further discuss the Phase 1b data and highlight what this means for its
development program moving forward. Click here to access the segment.
CIPN
is a common side effect of many chemotherapeutic drugs that induce peripheral nerve damage. CIPN can last for weeks to years after treatment
has ended and patients with CIPN often experience discomfort that can result in persistent, unbearable pain, as well as motor and autonomic
dysfunction that may limit the duration of their cancer treatment. Conventional pain medications and opioids are often ineffective against
peripheral neuropathy, creating a significant unmet need for new treatment options. Low dose IL-6 has been shown to stimulate
peripheral nerve growth in preclinical models, thereby ameliorating motor and sensory functions and normalizing the associated pain or
sensation disturbance of neuropathy.
“We
believe this highly encouraging data bridges the large atexakin alfa historical safety database in cancer patients and is foundational
in advancing the development of SON-080 to a Phase 2 study evaluating the neuroprotective and neuro-regenerative effects in DPN,”
said Pankaj Mohan, Ph.D., Sonnet Founder and Chief Executive Officer. “IL-6 is often dysregulated in diabetic patients, suggesting
there is disease modifying potential for the application of rhIL-6 in DPN. Given the high prevalence of neuropathy in diabetes and the
commensurate industry interest in this market, we have prioritized DPN as the best potential indication for Phase 2 development. We intend
to seek a partnership to move the asset forward towards commercialization.”
A
total of 9 patients were randomized between two different SON-080 dose groups and placebo in this portion of the study. The treatment
period was 12 weeks long and patients were followed-up for an additional 12 weeks.
The
Phase 1b data demonstrated SON-080 was well-tolerated at both 20 µg and 60 µg/dose, which was about 10-fold lower than the
maximum tolerated dose (MTD) for IL-6 that was established in previous clinical evaluations. Injection site erythema was the most prominent
treatment-related adverse event irrespective of the dose of SON-080, and was transient and mild in all but one case at each dose, where
it was moderate. Fatigue was reported occasionally and was more prominent at the higher dose. One patient who developed severe fatigue
and stopped dosing after one month was in the low-dose group. Headache, dizziness, and chills were reported infrequently in the high-dose
group; all were mild apart from a single moderate event with each symptom. All other adverse events were infrequent and mild.
“These
data suggest possible benefits in humans with various types of peripheral neuropathy due to cancer and diabetes. Interleukin-6 has been
extensively studied in cancer patients in the past, so the use of SON-080 in CIPN was expected to provide a similar adverse event profile
at low doses,” commented Richard Kenney, M.D., Sonnet’s Chief Medical Officer. “We now have a further understanding
of the adverse event profile and the opportunity to look at preliminary efficacy trends. We look forward to initiating a Phase 2 study
with a partner in the much larger DPN indication.”
The
Quality-of-Life Questionnaire-CIPN twenty-item scale (QLQ-CIPN20), a validated survey designed to assess cancer patients’ experience
of symptoms and functional limitations related to CIPN, was used as the primary indicator of response. While the number of patients in
each group was small, a trend toward improved scores within a month of starting therapy was seen for both dose groups as compared to
placebo in the overall scores. This greater improvement with SON-080 persisted after the 12 weeks of therapy had stopped, while the placebo
group scores returned to baseline. These results are in line with the preclinical model insights with low dose IL-6, although further
work with larger clinical groups is needed to substantiate this trend.
Multiple
cytokines were studied as part of the safety evaluation. There was no demonstrable drug effect on any of these inflammatory cytokine
serum levels during or after therapy with SON-080. However, there was a dose-related increase in serum amyloid alpha that persisted during
therapy, which returned to baseline once treatment was stopped. An expert consultant concluded that the degree of amyloid elevation seen
in this study for 12 weeks should be benign.
For
more information about the SB211 study, visit clinicaltrials.gov and reference identifier NCT05435742.
About
SON-080 as a Therapeutic Drug Candidate
SB211
studied a low dose of rhIL-6 called SON-080 that has an amino acid sequence identical to the native molecule. The trial targets serum
levels similar to those induced with moderate exercise, which triggers the natural healing of nerves, muscle, and bone. As a pleiotropic
cytokine, native IL-6 participates in several physiological processes, including tissue repair, glucose homeostasis, and the innate immune
response at lower levels, but it can result in acute pathological inflammation at higher serum levels. Preclinical models of CIPN and
DPN show that low dose rhIL-6 has the potential to stimulate nerve regrowth to re-establish normal sensations, thereby reducing pain
and normalizing some of the physiological conditions that had deteriorated due to nerve degeneration. Early versions of rhIL-6, including
Serono’s atexakin alfa and others, have been tested in hundreds of patients with cancer, diabetes, idiopathic aplastic anemia,
and in healthy controls, showing a maximum tolerated dose of 10 µg/kg three times a week (TIW). The IL-6-related fever, nausea,
and vomiting that were prominent adverse events at doses over 2.5 µg/kg TIW were substantially reduced at lower doses.
About
the SB211 Phase 1b/2a Trial
The
SB211 study was primarily designed to evaluate the safety, PK, PD, and initial efficacy of two dose levels of SON-080 compared to placebo.
The drug is self-administered subcutaneously three times a week in patients with CIPN lasting at least 3 months after chemotherapy. The
study was conducted at multiple sites in Australia, in a blinded fashion, comparing SON-080 to placebo. The primary endpoint explores
the safety and tolerability of SON-080, with key secondary endpoints intended to measure PK, PD, and immunogenicity. Preliminary efficacy
is being explored using standardized quality of life and pain questionnaires over the course of the trial.
About
Sonnet BioTherapeutics Holdings, Inc.
Sonnet
BioTherapeutics is an oncology-focused biotechnology company with a proprietary platform for innovating biologic drugs of single or bifunctional
action. Known as FHAB (Fully Human Albumin Binding), the technology utilizes a fully human single chain antibody fragment
(scFv) that binds to and “hitch-hikes” on human serum albumin (HSA) for transport to target tissues. Sonnet’s FHAB
was designed to specifically target tumor and lymphatic tissue, with an improved therapeutic window for optimizing the safety and efficacy
of immune modulating biologic drugs. FHAB is the foundation of a modular, plug-and-play construct for potentiating a range
of large molecule therapeutic classes, including cytokines, peptides, antibodies, and vaccines.
Forward-Looking
Statements
This
press release contains certain forward-looking statements within the meaning of Section 27A of the Securities Act of 1933 and Section21E
of the Securities Exchange Act of 1934 and Private Securities Litigation Reform Act, as amended, including those relating to the Company’s
cash runway, the Company’s product development, clinical and regulatory timelines, market opportunity, competitive position, possible
or assumed future results of operations, business strategies, potential growth opportunities and other statements that are predictive
in nature. These forward-looking statements are based on current expectations, estimates, forecasts and projections about the industry
and markets in which we operate and management’s current beliefs and assumptions.
These
statements may be identified by the use of forward-looking expressions, including, but not limited to, “expect,” “anticipate,”
“intend,” “plan,” “believe,” “estimate,” “potential, “predict,” “project,”
“should,” “would” and similar expressions and the negatives of those terms. These statements relate to future
events or our financial performance and involve known and unknown risks, uncertainties, and other factors which may cause actual results,
performance or achievements to be materially different from any future results, performance or achievements expressed or implied by the
forward-looking statements. Such factors include those set forth in the Company’s filings with the Securities and Exchange Commission.
Prospective investors are cautioned not to place undue reliance on such forward-looking statements, which speak only as of the date of
this press release. The Company undertakes no obligation to publicly update any forward-looking statement, whether as a result of new
information, future events or otherwise.
Investor
Relations Contact:
JTC Team, LLC
Jenene
Thomas
833-475-8247
SONN@jtcir.com
SOURCE:
Sonnet BioTherapeutics, Inc.
Exhibit
99.2
What
this Means: Sonnet BioTherapeutics Data from SON-080 Phase 1b/2 Study in Chemotherapy Induced Peripheral Neuropathy (CIPN)
Participants:
|
● |
Pankaj
Mohan, PhD – Founder and Chief Executive Officer |
|
● |
Richard
Kenney, M.D. – Chief Medical Officer |
|
● |
Gael
Hedou, PhD – Chief Operating Officer |
Sonnet
BioTherapeutics (Nasdaq: SONN)
Introduction:
Jenene Thomas
|
● |
Welcome
back for another What this Means segment. My name is Jenene Thomas, CEO of JTC IR and I will be the moderator today. |
Today
we are excited to welcome Sonnet BioTherapeutics to the Virtual Investor platform. I am pleased to be joined by some of the senior executives,
including Pankaj Mohan, Chief Executive Officer, Dr. Richard Kenney, Chief Medical Officer and Dr. Gael Hedou, Chief Operating Officer
of Sonnet BioTherapeutics, so happy to have you on our platform!
Before
we get started, I just want to inform our audience that Sonnet BioTherapeutics is listed on Nasdaq and trades under the ticker SONN.
During today’s discussion, the Company will be making forward-looking statements and I encourage everyone to view the Company’s
website at sonnetbio.com or the SEC’s website for their latest filings and information.
Moderated
Questions
|
1. |
These
look like encouraging data. Can you run us through what you saw Dr. Kenney? |
This
study was designed to show the efficacy and safety of Sonnet’s version of IL-6, which was manufactured using modern techniques
and builds on the extensive clinical safety database with prior versions of this recombinant cytokine. IL-6 is naturally produced at
low levels in the body in response to strenuous exercise to heal muscle and nerve cells and the doses we are giving mimic those levels.
The preclinical work suggested that injections of IL-6 could do the same thing after chemotherapy or diabetic damage.
The
trial results in the first 9 patients were pretty informative. We taught patients how to give themselves subcutaneous injections, like
a standard insulin shot. While the group size was small in this initial portion of our study, it appears that the pain and quality-of-life
scores showed a trend towards improvement after just one month compared to placebo and those improvements persisted after dosing was
stopped. While some inflammation developed at the site of injection, this was generally mild and went away after a few days. Even though
fatigue was an issue after 5% of the doses and resulted in one patient stopping early, the therapy was well-tolerated overall. Blood
tests showed no evidence of an inflammatory cytokine response, serum amyloid alpha was elevated during treatment but that returned to
baseline once treatment was stopped. We asked a national amyloid expert for an opinion and she thought this amount of exposure would
be benign.
|
2. |
Can
you give us a sense of the background for CIPN and these patients? What type of cancers did they have? What chemotherapies were they
on or are most associated with CIPN? And then how long they have had CIPN? |
CIPN
is caused by a variety of chemotherapies, like taxanes, organoplatinum compounds, or vinca alkaloids and, as one of the most common adverse
effects, is often dose-limiting. Patients had to have cancer that was stable or in remission but have CIPN that had been persistent for
more than 3 months with a pain score of at least 30/100. This is longer than most transient neuropathy and helped to standardize the
population to see if they might benefit from the SON-080 treatment.
|
3. |
The
Company intends to seek a partnership to support a Phase 2 study in diabetic peripheral neuropathy, or DPN. Dr. Hedou, as you have
been involved with this drug for over a decade, can you talk about the similarities between CIPN and DPN, and what gives the company
confidence that the signal they are seeing from this study in CIPN will translate to DPN patients? |
Neuropathic
symptoms result from the degeneration of the nerves that convey body functions, including all sensations felt at the skin level, motor
functions, and the control of autonomic organs such as digestive track, bladder, and heart. Degeneration of these nerves affect the related
function and may generate intractable pain, aberrant sensation, loss of motor functions and autonomic disturbances.
A
large number of neuropathies have been described that all point to the disturbances of nerve function. These can be perturbed by many
different external stressors, including physical, chemical, viral, oxygenation, or glucose levels. In diabetic peripheral neuropathy,
high glucose levels and deficient oxygenation of nerve terminals have been invoked to explain the degeneration of nerve fibers. IL-6
has been shown to improve blood flow around the nerves, which should improve local oxygen supply. Furthermore, IL-6 regulates glucose
homeostasis in part to normalize blood glucose levels.
IL-6
at the physiological level can stimulate expression of neuronal genes involved in axonal growth. Finally, IL-6 can enhance the proliferation
of cells that protect the neuronal axons, such as oligodendrocytes, and simulate the expression of myelin proteins, thereby reinforcing
the myelin sheath that was lost during degeneration of the axon. Taken together, the pleiotropic activities of IL-6 allow concerted actions
on a variety of physiological mechanisms pointing to a protective and regenerative action for the nerves, especially in the context of
diabetes.
|
4. |
Thinking
out loud here, you are well below your MTD, and a cancer patient with CIPN may have greater co-morbidities or a lower baseline quality
of life than a diabetic patient. So, it’s encouraging that the drug appears to be safe and well-tolerated in this CIPN population.
Dr. Kenney, can you talk about the differences between these populations and whether or not the company intends to push the dose
of SON-080 higher in the planned Phase 2 DPN study? |
The
dose has been set well below the MTD intentionally, as this is the range that helps regulate glucose and causes cell repair after exercise.
The prior clinical work showed that higher doses tend to cause adverse events. The initial efficacy trend we observed in this trial seems
to extend beyond the cessation of treatment. This is often the case when genetic and cellular components are at play, which generally
differs from the on and off switch of a receptor targeted by a very selective drug with no cellular or genetic downstream consequences.
Although further investigations are required to confirm these initial results, they nevertheless provide insights into the potential
mechanisms involved and guidance for establishment of the readouts to be included in the next trial. The DPN Phase 2 trial can be initiated
in Australia when it is approved by the Australian Safety Committee.
|
5. |
That’s
very interesting. Dr. Hedou, can
you expand upon those underlying or baseline differences in IL-6 levels between the CIPN and DPN patient that might make SON-080
more effective in DPN? |
DPN
is caused by poor oxygen and dysregulated glucose supplies to nerve endings. In the CIPN trial we were just depending on the properties
of IL-6 to regenerate the nerves that had been damaged by a chemical stressor. But IL-6 has the potential to do much more in this dose
range, as explained above. The preclinical work suggests that its role in glucose regulation and in the stimulation of endoneurial blood
flow will add to its nerve regenerative properties to tackle the specific mechanisms leading to neuropathy in diabetes patients.
|
6. |
Dr.
Kenney, can you talk about the unmet need in DPN? Medications such as pregabalin or gabapentin or antidepressants such as duloxetine
or amitriptyline are often used to treat DPN. How effective are these medications? And how can SON-080 fit into the treatment paradigm
for DPN patients? |
All
drugs currently approved for neuropathy only target pain and come with complex side effects. Unfortunately, neuropathic patients suffer
many more clinical signs and symptoms that profoundly affect their quality of life. Diabetic patients lose strength, can seriously burn
themselves, fall because they lose balance, present with digestive issues or incontinence, and experience significant itching, tingling,
numbness etc. These clinical manifestations are not relieved by current DPN medications at all. Regenerating nerves with IL-6 treatment
may restore normal nerve function and thereby normalize their sensations, as well as improving motor and autonomic capacities that are
impacting their quality of life.
|
7. |
Dr.
Mohan, what type of partnership is the company pursuing for SON-080? Is the company looking to out-license the asset or co-develop
with a partner? And can you talk about what impact securing a partnership for SON-080 might have on the rest of the pipeline? |
As
you have heard from Gael and Rick, I want to re-emphasize that SON-080 potentially addresses high unmet medical needs with multiple neuropathies
CIPN, DPN and autonomic neuropathies with significant historic clinical experience with safety, compelling preclinical data on disease
modification potential and now initial confirmation of such modification in human patients. The encouraging data is likely to potentially
accelerate our partnering efforts which are underway. Any such potential partnership may create non-dilutive funding to fund SON-1210
(first bispecific molecule) into clinical trials and further develop SON-1411.
Jenene
Transition: Closing
|
● |
With
that, this concludes the Virtual Investor What this Means segment with Sonnet BioTherapeutics. I would like to thank Drs. Pankaj
Mohan, CEO, Richard Kenney, CMO, and Gael Hedou, COO, of Sonnet BioTherapeutics for joining us today. |
|
|
|
|
● |
As
a reminder Sonnet BioTherapeutics trades on Nasdaq under the ticker SONN. |
|
|
|
|
● |
If
you like what you saw today, I encourage you to visit sonnetbio.com for more information on the Company and to sign up to follow
the company to receive their alerts as well as follow their social channels to stay current on the latest information. |
|
|
|
|
● |
You
can also visit virtualinvestorco.com for our latest segments and event calendar! |
|
|
|
|
● |
Thank
you and have a great rest of your day! |
This
presentation contains certain forward-looking statements within the meaning of Section 27A of the Securities Act of 1933 and Section21E
of the Securities Exchange Act of 1934 and Private Securities Litigation Reform Act. These forward-looking statements are based on current
expectations, estimates, forecasts and projections about the industry and markets in which we operate and management’s current
beliefs and assumptions. These statements may be identified by the use of forward-looking expressions, including, but not limited to,
“expect,” “anticipate,” “intend,” “plan,” “believe,” “estimate,”
“potential, “predict,” “project,” “should,” “would” and similar expressions and
the negatives of those terms. These statements relate to future events or the Company’s financial performance and involve known
and unknown risks, uncertainties, and other factors which may cause actual results, performance or achievements to be materially different
from any future results, performance or achievements expressed or implied by the forward-looking statements. Such factors include those
set forth in the Company’s filings with the Securities and Exchange Commission. Prospective investors are cautioned not to place
undue reliance on such forward-looking statements, which speak only as of the date of this presentation. The Company undertakes no obligation
to publicly update any forward-looking statement, whether as a result of new information, future events or otherwise.
v3.24.2
Cover
|
Jul. 24, 2024 |
Cover [Abstract] |
|
Document Type |
8-K
|
Amendment Flag |
false
|
Document Period End Date |
Jul. 24, 2024
|
Entity File Number |
001-35570
|
Entity Registrant Name |
SONNET
BIOTHERAPEUTICS HOLDINGS, INC.
|
Entity Central Index Key |
0001106838
|
Entity Tax Identification Number |
20-2932652
|
Entity Incorporation, State or Country Code |
DE
|
Entity Address, Address Line One |
100
Overlook Center
|
Entity Address, Address Line Two |
Suite 102
|
Entity Address, City or Town |
Princeton
|
Entity Address, State or Province |
NJ
|
Entity Address, Postal Zip Code |
08540
|
City Area Code |
(609)
|
Local Phone Number |
375-2227
|
Written Communications |
false
|
Soliciting Material |
false
|
Pre-commencement Tender Offer |
false
|
Pre-commencement Issuer Tender Offer |
false
|
Title of 12(b) Security |
Common
Stock, $0.0001 par value per share
|
Trading Symbol |
SONN
|
Security Exchange Name |
NASDAQ
|
Entity Emerging Growth Company |
false
|
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