false 0001106838 0001106838 2024-12-17 2024-12-17 iso4217:USD xbrli:shares iso4217:USD xbrli:shares

 

 

 

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): December 17, 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 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 December 17, 2024, Sonnet BioTherapeutics Holdings, Inc. (the “Registrant”) issued a press release regarding its financial results for the fiscal year ended September 30, 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 Operation 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.

 

Exhibit No.   Exhibit
     
99.1   Press Release, dated December 17, 2024
104   Cover Page Interactive Data File (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 on its behalf by the undersigned hereunto duly authorized.

 

  Sonnet BioTherapeutics Holdings, Inc.
  a Delaware corporation
  (Registrant)
   
Date: December 17, 2024 By: /s/ Pankaj Mohan, Ph.D.
  Name: Pankaj Mohan, Ph.D.
  Title: Chief Executive Officer

 

 

 

Exhibit 99.1

 

 

Sonnet BioTherapeutics Reports Fiscal Year 2024 Financial Results and Provides Corporate Update

 

Continued progress with both clinical trials of lead program, SON-1010, for solid tumors and Platinum-Resistant Ovarian Cancer (PROC)

 

Executed licensing agreement to support initiation of a Phase 2 clinical trial of SON-080 in Diabetic Peripheral Neuropathy (DPN)

 

Multiple value-driving milestones expected throughout calendar year 2025 as well as pipeline expansion opportunities across the solid tumor market

 

Total annual operating expenses reduced by an approximate 37% as compared to fiscal year 2023

 

Approximately 43% of total annual operating expenses during fiscal year 2024 were covered by non-dilutive funding received during fiscal year 2024 from the New Jersey Tax Certificate Transfer and Australia R&D Tax Incentive Programs

 

PRINCETON, NJ / ACCESSWIRE / December 17, 2024 / Sonnet BioTherapeutics Holdings, Inc. (the “Company” or “Sonnet”) (NASDAQ: SONN), a clinical-stage company developing targeted immunotherapeutic drugs, reported today financial results for the fiscal year ended September 30, 2024 and provided a corporate update.

 

“We are very pleased with the progress we have made across all facets of the company’s operations. On the financial front, we have delivered on our stated objective of cutting costs through an approximate 37% reduction in total operating expenses versus last year, which will help to extend our cash runway, combined with being able to leverage non-dilutive funding and capital markets financings. Additionally, we have executed on our partnership plans to advance both our SON-080 program and SON-1210 program to their respective next stages of development and continue to believe in their potential to address indications of significant unmet need,” commented Pankaj Mohan, Ph.D., Founder and Chief Executive Officer of Sonnet. “Looking ahead, our focus is on advancing our lead program, SON-1010, and we are pleased to be on track for key data readouts from our ongoing SB101 trial for solid tumors and our SB221 trial for PROC. We look forward to the upcoming data readouts to help further unlock the intrinsic value of our FHAB technology platform.”

 

Recent Highlights

 

  Announced topline safety data following successful completion of SON-1010 monotherapy dose escalation in the Phase 1 SB101 trial;
     
  Announced the publication of extensive discovery, development, and preclinical data regarding SON-1010, demonstrating its mechanism of action in a paper entitled, “SON-1010: an albumin-binding IL-12 fusion protein that improves cytokine half-life, targets tumors, and enhances therapeutic efficacy,” in Frontiers in Immunology;

 

 
 

 

  Granted U.S. Patent No. 12,134,635 covering two of its novel drug candidates, SON-1411 (IL-18BPR-FHAB-IL12) and SON-1400 (IL-18BPR-FHAB), each containing a modified version of recombinant human interleukin-18 (BPR = Binding Protein Resistant);
     
  Entered into a licensing agreement with Alkem Laboratories Limited for the research, development, manufacturing, marketing, and commercialization of the SON-080 molecule for the treatment of DPN in India;
     
  Received preliminary approval for the sale of tax credits from the New Jersey Technology Business Tax Certificate Transfer Program administered by the New Jersey Economic Development Authority (NJEDA); and
     
  Entered into a Master Clinical Collaboration Agreement with the Sarcoma Oncology Center to advance the development of SON-1210 in combination with chemotherapy for the treatment of metastatic pancreatic cancer.

 

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)

 

This first-in-human study is primarily designed to evaluate the safety, tolerability, PK, and PD of multiple ascending doses of SON-1010 in cancer patients and is being conducted at several sites across the United States. The Company recently completed enrollment and dose escalation in the Phase 1 SB101 clinical trial of SON-1010 (IL12-FHAB) in adult patients with advanced solid tumors. Additionally, the Company reported that results of SON-1010 at the highest dose have been formally evaluated by the Safety Review Committee. The study has enrolled 24 subjects to date. Primary outcome measures for the study were to evaluate the safety and tolerability of SON-1010 and establish the MTD.

 

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). This study was recently expanded to include the MTD of SON-1010 from SB101. Enrollment remains ongoing and an update on safety at the MTD in that trial is expected in Q1 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

 

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

 

As previously announced, the Company successfully completed two IND-enabling toxicology studies of SON-1210 in non-human primates (NHPs), which demonstrated no overt toxicity in the GLP study apart from the expected and mild, on-target changes in hematology and clinical chemistry parameters that resolved completely within 14 to 21 days post-dosing. A significant increase in interferon gamma (IFNγ), which was controlled and prolonged, was noted as early as one day following administration, with no apparent increase in other proinflammatory cytokines. IFNγ is a well-known pharmacodynamic biomarker that is required for anti-tumor efficacy in preclinical models. Other signs of cytokine imbalance, or uncontrolled increase of pro-inflammatory cytokines (including TNF-α, IL-1β, and IL-6) were notably absent from all dose levels tested in the study.

 

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.

 

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 (the “Licensing Agreement”) with Alkem Laboratories Limited (“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 chemotherapy induced neuropathy (CIPN) and autonomic neuropathy in India. Alkem will conduct all clinical trials it believes appropriate to obtain regulatory approval in India of SON-080 for the treatment of DPN.

 

 
 

 

Summary of Financial Results for the Fiscal Year 2024

 

As of September 30, 2024, Sonnet had $0.1 million cash on hand. The Company believes that based on cash on hand at September 30, 2024, together with the approximate $7.7 million recently received through the sale of common stock and warrants in November and December 2024, $0.7 million received from the R&D Tax Incentive Program in Australia in November 2024 to satisfy the Company’s incentive tax receivable, and $0.5 million received in October 2024 as an upfront payment related to the License Agreement, which after tax withholdings resulted in a net payment of $0.4 million, it has sufficient funds for projected operations into July 2025.

 

Research and development expenses were $5.7 million for the year ended September 30, 2024, compared to $11.8 million for the year ended September 30, 2023.

 

General and administrative expenses were $6.1 million for the year ended September 30, 2024, compared to $7.1 million for the year ended September 30, 2023.

 

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 Section 21E of the Securities Exchange Act of 1934 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 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

 

 
 

 

Sonnet BioTherapeutics Holdings, Inc.

Consolidated Balance Sheets

 

   September 30, 
   2024   2023 
Assets          
Current assets:          
Cash and cash equivalents  $149,456   $2,274,259 
Prepaid expenses and other current assets   1,206,409    1,677,396 
Incentive tax receivable   762,078    786,574 
Total current assets   2,117,943    4,738,229 
Property and equipment, net   20,523    33,366 
Operating lease right-of-use asset   123,417    193,689 
Deferred offering costs   15,000    49,988 
Other assets   494,147    414,206 
Total assets  $2,771,030   $5,429,478 
Liabilities and stockholders’ deficit          
Current liabilities:          
Accounts payable  $2,183,416   $2,201,999 
Accrued expenses and other current liabilities   942,489    3,230,922 
Current portion of operating lease liability   84,291    73,048 
Deferred income       18,626 
Total current liabilities   3,210,196    5,524,595 
Operating lease liability, net of current portion   46,573    130,863 
Total liabilities   3,256,769    5,655,458 
Commitments and contingencies (Note 5)          
Stockholders’ deficit:          
Preferred stock, $0.0001 par value: 5,000,000 shares authorized; no shares issued or outstanding        
Common stock, $0.0001 par value: 125,000,000 shares authorized; 650,284 and 218,786 issued and outstanding at September 30, 2024 and 2023, respectively   65    22 
Additional paid-in capital   117,195,181    110,017,751 
Accumulated deficit   (117,680,985)   (110,243,753)
Total stockholders’ deficit   (485,739)   (225,980)
Total liabilities and stockholders’ deficit  $2,771,030   $5,429,478 

 

 
 

 

Sonnet BioTherapeutics Holdings, Inc.

Consolidated Statements of Operations

 

   Years ended September 30, 
   2024   2023 
Collaboration revenue  $18,626   $147,805 
Operating expenses:          
Research and development   5,737,252    11,814,690 
General and administrative   6,130,845    7,125,732 
Total operating expense   11,868,097    18,940,422 
Loss from operations   (11,849,471)   (18,792,617)
Foreign exchange gain (loss)   84,293    (40,077)
Other income   4,327,946     
Net loss  $(7,437,232)  $(18,832,694)
           
Per share information:          
Net loss per share, basic and diluted  $(11.35)  $(145.13)
Weighted average shares outstanding, basic and diluted   655,240    129,760 

 

 

 

v3.24.4
Cover
Dec. 17, 2024
Cover [Abstract]  
Document Type 8-K
Amendment Flag false
Document Period End Date Dec. 17, 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
Trading Symbol SONN
Security Exchange Name NASDAQ
Entity Emerging Growth Company false

Sonnet BioTherapeutics (NASDAQ:SONN)
Gráfica de Acción Histórica
De Nov 2024 a Dic 2024 Haga Click aquí para más Gráficas Sonnet BioTherapeutics.
Sonnet BioTherapeutics (NASDAQ:SONN)
Gráfica de Acción Histórica
De Dic 2023 a Dic 2024 Haga Click aquí para más Gráficas Sonnet BioTherapeutics.