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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): February 13, 2025
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 offices) |
|
(Zip
Code) |
Registrant’s
telephone number, including area code: (609) 375-2227
N/A
(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 |
|
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
2.02. Results of Operations and Financial Condition.
On
February 13, 2025, Sonnet BioTherapeutics Holdings, Inc. (the “Company”) issued a press release regarding its financial results
for the three months ended December 31, 2024. A copy of the press release is furnished as Exhibit 99.1 hereto and is incorporated by
reference herein.
Item
7.01. Regulation FD.
See
“Item 2.02 Results of Operations and Financial Condition” above.
The
information in this Current Report on Form 8-K under Items 2.02 and 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.
Forward-Looking
Statements
This
Current Report on Form 8-K, including Exhibit 99.1 furnished herewith, 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.
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.
| |
Sonnet
BioTherapeutics Holdings, Inc. |
| |
|
| Date:
February 13, 2025 |
By: |
/s/
Pankaj Mohan, Ph.D. |
| |
Name: |
Pankaj
Mohan, Ph.D. |
| |
Title: |
Chief
Executive Officer |
Exhibit
99.1
Sonnet
BioTherapeutics Provides Fiscal Year 2025 First Quarter Business and Earnings Update
Completion
of SON-1010 (IL12-FHAB) monotherapy dose escalation in Phase 1 SB101 trial. Stable disease (SD) at four
months post-initiation of dosing was seen in 48% evaluable monotherapy patients, and one patient dosed at the MTD, resulting in a partial
response (PR)
Continued progress with clinical trials evaluating
SON-1010 in combination with Atezolizumab, for Platinum-Resistant Ovarian Cancer (PROC) and in combination with trabectedin in certain
advanced soft-tissue sarcomas (STS)
SON-1210 bifunctional Interleukins 12 and 15,
on FHAB platform, in combination with chemotherapy for the treatment of advanced solid tumors and metastatic pancreatic cancer expected
to initiate clinical trial with first patient dosed in H1 calendar year 2025
Company has initiated a licensing
partnership in India for SON-080 in October 2024 and reorganizes leadership team focused on advancing business development
opportunities
PRINCETON,
NJ / Globe Newswire / February 13, 2025 / Sonnet BioTherapeutics Holdings, Inc. (the “Company” or “Sonnet”)
(NASDAQ: SONN), a clinical-stage company developing targeted immunotherapeutic drugs, today provided its financial results for the three
months ended December 31, 2024 and provided a business update.
“We
have made strides in our Phase 1 SB101 trial with established clinical benefit including a 45% reduction in tumor size by RECIST criteria
indicating a partial response and demonstrating the effectiveness of our FHAB® platform. This
encouraging data with SON-1010 excites us with the ongoing combination trials with Atezolizumab and with the initiation of
recruitment for the combination with trabectedin (Yondelis®). Additionally, we continue to bolster our global patent
estate and differentiate our plug and play strategy from any competitive technologies that may leverage the beneficial characteristics
of binding to human serum albumin,” commented Pankaj Mohan, Ph.D., Founder and CEO of Sonnet. “As we look to the remainder
of the calendar year, our focus is on our clinical programs and building on our momentum toward meeting potentially catalytic milestones
including a number of key clinical data readouts; all of which we believe have the potential to build shareholder value.”
Recent
Highlights
| ● | Entered
into a licensing agreement with Alkem Laboratories Limited (“Alkem”) to develop
and commercialize SON-080 in India (October 2024). |
| ● | Completion
of SON-1010 (IL12-FHAB) Monotherapy Dose Escalation in Phase 1 SB101 trial
and announced topline safety data (December 2024). |
| | | |
| | ● | Closed
a registered direct offering and concurrent private placement priced at-the-market under
Nasdaq rules for aggregate gross proceeds of $3.9 million (December 2024). |
| | | |
| ● | Announced
granting of EU Patent No. EP3583125 B1 covering its FHAB®
platform technology (January 2025). |
| | | |
| ● | Expanded
its Phase 1 SB101 clinical study of SON-1010 (IL12-FHAB) in adult patients with
advanced solid tumors by adding a new patient cohort to evaluate the effect of SON-1010 in
combination with trabectedin (January 2025). |
Lead
Clinical Programs Update
SON-1010:
Targeted Immune Activation Cancer Therapy, Turning ‘Cold’ Tumors ‘Hot’, Initially Targeting Solid Tumors and
Platinum-Resistant Ovarian Cancer (PROC)
Phase
1 Trial (SB101 Trial): Advanced Solid Tumors (Monotherapy)
The
Company announced the topline safety data from the SB101 trial and completion of dose escalation in December 2024, establishing the MTD
as 1200 ng/kg. The final 1200 ng/kg dose-escalation cohort was increased in size to 6 patients to enhance the assessment of PK and PD
at the MTD. The SB101 trial employed a ‘desensitizing’ first dose of 300 ng/kg to take advantage of the known tachyphylaxis
with rhIL-12, with the intention of minimizing toxicity and allowing for higher maintenance doses.
Of
the 24 patients dosed to date, 17 (71%) had stable disease at the first follow-up CT, 12 of whom were progressing at study entry. 10
of the 21 evaluable patients (48%) remained stable at four months, suggesting SON-1010 clinical benefit, and one of those patients in
the highest dose cohort, who has clear cell sarcoma, had a PR with a 45% reduction in tumor size by RESIST criteria. As previously disclosed,
one patient in the first dose cohort with endometrial sarcoma who was progressing at study entry had evidence of improvement after 11
months, with smaller tumors and complete resolution of ascites. This patient later progressed at 23 months and started chemotherapy.
No dose-limiting toxicities or related serious adverse events (SAE) have occurred to date. The safety and toxicity profile that has developed
is typical for a Phase 1 oncology trial, with the majority of adverse events (AEs) being reported as mild. All AEs seen to date have
been transient, with no evidence of cytokine release syndrome.
The
Company recently announced expansion of its Phase 1 SB101 clinical study of SON-1010 (IL12-FHAB) in adult patients with advanced
solid tumors to add a new cohort to evaluate the effect of SON-1010 in combination with trabectedin in certain advanced soft-tissue sarcomas
(STS), following the successful completion of monotherapy dose escalation. Enrollment in this cohort is underway and is expected to be
completed in H1 calendar year 2025. Topline safety data of the combination with trabectedin is expected in H2 calendar year 2025. No
new safety concerns have been reported to date.
For
more information about the SB101 clinical trial, visit clinicaltrials.gov and reference identifier NCT05352750.
Phase
1b/2a Trial (SB221 Trial): Advanced Solid Tumors and PROC (Combo with Atezolizumab)
The
second trial is a global Phase 1b/2a multicenter, dose-escalation and randomized proof-of-concept study to assess the safety, tolerability,
PK, PD, and efficacy of SON-1010 administered subcutaneously (SC) in combination with atezolizumab given intravenously (IV) (in collaboration
with Genentech, a member of the Roche Group). Enrollment remains ongoing and an update on safety in that trial is expected in Q1 calendar
year 2025.
For
more information about the SB221 clinical trial, visit clinicaltrials.gov and reference identifier NCT05756907.
SON-1010
Upcoming Milestones
| ● | Phase
1: Solid Tumors (Monotherapy) |
| ○ | H1
Calendar Year 2025: Topline Efficacy Data |
| ● | Phase
1b/2a: PROC (Combo with Atezolizumab) |
| ○ | Q1
Calendar Year 2025: Additional Safety Data |
| ○ | H2
Calendar Year 2025: RP2D & Topline Efficacy Data |
| ● | Phase
1: STS (Combo with Trabectedin) |
| ○ | H2
Calendar Year 2025: Topline Safety Data |
SON-1210:
Proprietary, Bifunctional Version of Human Interleukins 12 (IL-12) and 15 (IL-15), Configured Using Sonnet’s Fully Human
Albumin Binding (FHAB) platform, in Combination with Chemotherapy for the Treatment of Advanced Solid Tumors and Metastatic
Pancreatic Cancer
In
August 2024, the Company entered into a Master Clinical Collaboration Agreement with the Sarcoma Oncology Center to conduct an investigator-initiated
Phase 1/2a clinical study to evaluate SON-1210 in combination with several chemotherapeutic agents including but not limited to NALIRIFOX
(the combination of liposomal irinotecan, 5-fluorouracil/leucovorin, and oxaliplatin) for the specific treatment of metastatic pancreatic
cancer. The NALIRIFOX regimen is U.S. FDA-approved for the treatment of metastatic pancreatic cancer in the front-line and refractory
settings. The Company expects to submit the IND for SON-1210 in Q1 calendar year 2025.
SON-1210
Upcoming Milestones
| ● | Q1
Calendar Year 2025: IND Submission |
| ● | H1
Calendar Year 2025: 1st Patient Dosed in Investigator-Initiated
Phase 1/2a Study |
SON-080:
Low dose of rhIL-6 for Chemotherapy-Induced Peripheral Neuropathy (CIPN) and Diabetic Peripheral Neuropathy (DPN)
In
October 2024, the Company entered into a licensing agreement with Alkem for the research, development, manufacturing, marketing, and
commercialization of its SON-080 molecule for the treatment of DPN in India and the manufacturing, marketing, and commercialization of
SON-080 for CIPN and autonomic neuropathy in India. Alkem will conduct all clinical trials it believes appropriate to obtain regulatory
approval of SON-080 in India for the treatment of DPN. Subsequent to the partnership established with Alkem, preparations are being made
to support initiation of a Phase 2 clinical trial in DPN, a mechanistically synergistic and larger, high-value indication with unmet
medical need.
SON-080
Upcoming Milestone
| ● | H2
Calendar Year 2025: Initiation of Phase 2 Trial |
Summary
of Financial Results for First Quarter Fiscal Year 2025
For
the fiscal first quarter ended December 31, 2024, Sonnet reported a net loss of $3.2 million, or $1.56 per basic and diluted share, compared
to a net loss of $1.2 million, or $2.46 per basic and diluted share, for the for the fiscal quarter ended December 31, 2023.
As
of December 31, 2024, Sonnet had cash and cash equivalents of $4.9 million.
Company
Leadership Reorganization – The Company has promoted Dr. Stephen McAndrew from his role as Senior Vice President, Business
Development, to Chief Business Officer to enhance its focus on business development, effective February 17, 2025. Mr. Jay Cross submitted
his resignation as Chief Financial Officer, effective February 21, 2025. Mr. Cross will be succeeded by Mr. Donald Griffith, CPA, who
has been promoted as the new Chief Financial Officer from his role as Controller, effective February 21, 2025. This update to the Company’s
leadership team will preserve a continued focus on advancing business development opportunities while remaining vigilant on cost controls.
About
Sonnet BioTherapeutics Holdings, Inc.
Sonnet
is an oncology-focused biotechnology company with a proprietary platform for developing targeted biologic drugs with 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 platform 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.
Sonnet’s
lead program, SON-1010, or IL-12-FHAB, is in development for the treatment of solid tumors and ovarian cancer. SON-1010 is
being evaluated in an ongoing Phase 1/2a study through a Master Clinical Trial and Supply Agreement, along with ancillary Quality and
Safety Agreements, with Roche in combination with atezolizumab (Tecentriq®) for the treatment of platinum-resistant ovarian
cancer (PROC). The Company is also evaluating its second program, SON-1210, an IL12-FHAB-IL15 for solid tumors, in collaboration
with the Sarcoma Oncology Center to commence an investigator-initiated and funded Phase 1/2a study for the treatment of pancreatic cancer.
The
Company’s SON-080 program is a low dose of rhIL-6 in development for Chemotherapy-Induced Peripheral Neuropathy (CIPN) and Diabetic
Peripheral Neuropathy (DPN). SON-080 demonstrated encouraging results in a Phase 1b/2a clinical trial, being well tolerated with no evidence
of a pro-inflammatory cytokine response. In October 2024, Sonnet announced an India license agreement with Alkem Laboratories, Inc. who
will assume responsibility for advancing development of the SON-080 program into a Phase 2 study in DPN.
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
908-824-0775
SONN@jtcir.com
v3.25.0.1
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Sonnet BioTherapeutics (NASDAQ:SONN)
Historical Stock Chart
From Jan 2025 to Feb 2025
Sonnet BioTherapeutics (NASDAQ:SONN)
Historical Stock Chart
From Feb 2024 to Feb 2025
