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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): December 14, 2023
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 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 ☐
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 14, 2023, Sonnet BioTherapeutics Holdings, Inc. (the “Registrant”) issued a press release regarding its financial
results for the fiscal year ended September 30, 2023. A copy of the press release is furnished as Exhibit 99.1 hereto and is incorporated
by reference herein.
Forward-Looking
Statements
This
report, including Exhibit 99.1 furnished herewith, contains forward-looking statements within the meaning of the federal securities laws.
Forward-looking statements typically are identified by use of terms such as “may,” “will,” “should,”
“plan,” “expect,” “anticipate,” “estimate” and similar words, and the opposites of such
words, although some forward-looking statements are expressed differently. Forward-looking statements involve known and unknown risks
and uncertainties that exist in the Registrant’s operations and business environment, which may be beyond the Registrant’s
control, and which may cause actual results, performance or achievements to be materially different from future results, performance
or achievements expressed or implied by such forward-looking statements. All statements other than statements of historical fact are
statements that could be forward-looking statements. For example, forward-looking statements include, without limitation: statements
regarding prospects for additional customers; market forecasts; projections of earnings, revenues, synergies, accretion or other financial
information; and plans, strategies and objectives of management for future operations. The risks and uncertainties referred to above
include, but are not limited to, risks detailed from time to time in the Registrant’s filings with the Securities and Exchange
Commission, including its Annual Report on Form 10-K for the year ended September 30, 2023. These risks could cause actual results to
differ materially from those expressed in any forward-looking statements made by, or on behalf of, the Registrant. Forward-looking statements
represent the judgment of management of the Registrant regarding future events. Although the Registrant believes that the expectations
reflected in such forward-looking statements are reasonable at the time that they are made, the Registrant can give no assurance that
such expectations will prove to be correct. Unless otherwise required by applicable law, the Registrant assumes no obligation to update
any forward-looking statements, and expressly disclaims any obligation to do so, 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. |
|
a Delaware corporation |
|
(Registrant) |
|
|
|
Date:
December 14, 2023 |
By: |
/s/
Pankaj Mohan, Ph.D. |
|
Name: |
Pankaj
Mohan, Ph.D. |
|
Title: |
Chief
Executive Officer |
Exhibit 99.1
Sonnet
BioTherapeutics Provides Fiscal Year 2023 Business and Financial Update
PRINCETON,
NJ / ACCESSWIRE / December 14, 2023 / Sonnet BioTherapeutics Holdings, Inc. (NASDAQ:SONN) (“Sonnet” or the “Company”),
a biopharmaceutical company developing innovative targeted biologic drugs focused on oncology, announced today its financial results
for the fiscal year ended September 30th, 2023 and provided a business update.
“Sonnet
has had a very productive year, exemplified by important achievements across our pipeline. The successful completion of the Phase 1 SB102
study with SON-1010 in healthy volunteers, combined with the initial data reported from the Phase 1 SB101 study in cancer patients propelled
us forward into receiving FDA Investigational New Drug (IND) acceptance for the Phase 1b/2a SB221 combination study of SON-1010 with
Roche’s atezolizumab, in platinum-resistant ovarian cancer (PROC),” commented Pankaj Mohan, Ph.D., Founder and CEO. “Our
efforts to advance our pipeline continue and are accompanied by Janssen’s ongoing evaluation of SON-1010, SON-1210 and SON-1410
in combination with certain proprietary cell therapy assets. We are also working diligently to complete enrollment of the first portion
of the Phase 1b SB211 study of SON-080 in chemotherapy-induced peripheral neuropathy (CIPN), with the hope of having early safety data
available during the first quarter of 2024. We also expect to be able to share safety data from the SB102 and SB221 studies of SON-1010
during the first half of the year. In all, 2024 should be another exciting year for the company.”
Fiscal
Year 2023 and Recent Corporate Updates
Announced
Collaboration Agreement with Roche: On January 9, 2023, Sonnet announced a collaboration agreement with Roche for the clinical
evaluation of SON-1010 with atezolizumab. The companies have entered into a Master Clinical Trial and Supply Agreement (MCSA), along
with ancillary Quality and Safety Agreements, to study the safety and efficacy of the combination of SON-1010 and atezolizumab in a platinum-resistant
ovarian cancer (PROC) patient setting. Further, the companies will provide SON-1010 and atezolizumab, respectively, for use in the Phase
1b/Phase 2a combination safety, dose-escalation, and efficacy study (SB221). On August 16, Sonnet announced that the FDA accepted the
Investigational New Drug application (IND) for the use of SON-1010 in ovarian cancer, authorizing the companies to move forward with
the SB221 trial.
Sonnet
is pleased to provide the following updates on its pipeline assets:
SON-1010
(IL12-FHAB): In January 2023, Sonnet announced data from SB102, a single-ascending dose (SAD) Phase 1 clinical trial designed
to carefully study the pharmacokinetics (PK) and pharmacodynamics (PD) of SON-1010 in preparation for combination studies. Typical dose-related
increases were seen with SON-1010 in the serum after subcutaneous (SC) administration. Drug levels peaked at about 11 hours and the mean
elimination half-life (t½) after the 150 ng/kg dose of SON-1010 was 112 hours, compared to 12 hours for rhIL-12 given SC, as reported
in the literature.
In
April, Sonnet presented additional data from the SB101 study of SON-1010 at the 2023 AACR Annual Meeting. SB101 is a SAD trial in adult
patients with advanced solid tumors that commenced in the second quarter of 2022 and is currently enrolling the final dose cohort. Of
the 15 patients from SB101 who were evaluable for follow-up at this latest cutoff, 9 had stable disease at the first follow-up scan,
4 of which were already progressing at study entry. At the four-month follow-up, 5 of 14 patients remained stable at the second scan,
suggesting clinical benefit of SON-1010 in 36% of patients. As an example, the first patient dosed, who has an aggressive endometrial
sarcoma, had target tumor shrinkage with complete resolution of ascites at one point and has been clinically stable for over a year.
SON-1010 has been safe and tolerable at all doses tested to date. Adverse events have generally been mild/moderate and transient in nature,
with no study discontinuations for safety reasons. In addition, adverse effects have been less numerous and less intense with subsequent
doses. Comparison of the PK curves between the two studies suggests that SON-1010 may be targeting tumors, as it was designed to do.
Cytokine analysis following each dose revealed controlled and prolonged induction of interferon gamma (IFNγ) that peaked at 24
to 48 hours and returned to baseline after 2 to 4 weeks, which may improve tumor control. A small increase in IL-10 was observed with
each dose, as might be expected in response to IFNγ. There was either a minimal or no signal for IL-1β, IL-6, IL-8, and TNFα
and no indication of any potential for cytokine release syndrome (CRS) at these doses. Safety data from final dose escalation in the
SB101 study are expected during the first half of 2024.
Following
FDA acceptance of the IND in August, Sonnet launched the SB221 study with several patients currently being dosed. This trial consists
of a modified 3+3 dose-escalation design in Part 1 to establish the maximum tolerated dose (MTD) of SON-1010 with a fixed dose of atezolizumab.
Clinical benefit in PROC will be confirmed in an expansion group to establish the recommended Phase 2 dose. Part 2 of the study will
then investigate SON-1010 monotherapy, its use in combination with atezolizumab, or the standard of care (SOC) for PROC in a randomized
comparison to show proof-of-concept (POC). Initial safety data from Part 1 of the SB221 study are expected during the first half of 2024.
In
September 2023, Sonnet announced the completion of two independent in vivo proof-of-concept (POC) studies to show the biodistribution
of interleukin-FHAB molecules to the tumor microenvironment (TME), using labs with expertise in radiolabeling biologics and
in vivo biodistribution analysis. The labs employed different radiolabeling methodologies (99mTc or 89Zr)
for mIL-12 and mIL12-FHAB. The two studies were completed using the B16F10 mouse melanoma model to measure the accumulation
of radiolabeled product and tumor volume inhibition over various time points. Both studies indicated that mIL12-FHAB had significantly
higher tumor accumulation, 2.5-4.7 times higher on average at the longer time points, and increased retention when compared to mIL-12.
Accumulation was demonstrated in tumors compared to normal mice, and was transient in liver, kidney, and other organs, as expected. Importantly,
radiolabeled mIL12- FHAB also demonstrated measurable accumulation in the draining lymph nodes. Overall, these findings have
important implications for therapeutic applications of any mono-(ILx-FHAB) or bi-functional (ILx-FHAB -ILy) molecules
demonstrating enhanced tumor targeting and accumulation, as well as the potential for improved efficacy that could lead to a variety
of drug candidates.
SON-1210
(IL12-FHAB-IL15): In February 2023, Sonnet announced data from two successfully completed IND-enabling toxicology studies
with SON-1210 in non-human primates. The compound elicited no serious adverse events in repeat, subcutaneous dosing and was well-tolerated
using dosing levels at least 50x higher than the highest anticipated human clinical dose level. Sonnet is prepared to initiate the regulatory
authorization process for SON-1210, pending the outcome of any partnering activity.
SON-1410
(IL18-FHAB-IL12): Cell line development and process development are ongoing, with early experimental drug supply suitable
for formulation and analytical method development activities. After some delays in 2023, activities will continue into 2024 with the
potential to generate a drug suitable for preclinical studies and subsequent human studies.
SON-080
(low-dose IL-6): Enrollment of the first portion of the SB211 study in CIPN is nearing completion, which should position the DSMB
to complete its review of the preliminary safety data during the first calendar quarter of 2024.
John
Cini, Ph.D., Sonnet’s CSO and Co-founder commented on the fiscal year’s R&D accomplishments, saying, “The biodistribution
data we announced in September further confirmed the ability of the FHAB technology to extend therapeutic half-life and potentiate
tumor targeting, which, combined with the clinical data we presented at AACR in April, position the platform as a differentiated approach
for developing next-generation, cytokine-based oncologic drugs. We are excited about the opportunity to continue to highlight our pipeline
assets at upcoming medical conferences and through the publication of peer-reviewed articles that elucidate our findings.”
Financings
Completed: On February 10, 2023, we closed a public offering of common stock and certain warrants for net proceeds of
$13.6 million through the issuance and sale of 530,222 shares of our common stock and, to certain investors, pre-funded warrants to purchase
101,090 shares of common stock, and accompanying common warrants to purchase up to an aggregate of 1,262,618 shares of our common stock.
The public offering price of each share of common stock (or pre-funded warrant in lieu thereof) and accompanying common warrant was $23.76.
On
June 30, 2023, we closed a registered direct offering of common stock (and common stock equivalents in lieu thereof) and a concurrent
private placement of certain common stock warrants for net proceeds of $1.9 million through the issuance and sale of 166,363 shares of
our common stock and, to certain investors, pre-funded warrants to purchase 60,909 shares of common stock, and accompanying common warrants
to purchase up to an aggregate of 227,272 shares of our common stock. The offering price of each share of common stock (or pre-funded
warrant in lieu thereof) and accompanying common warrant was $9.90.
On
October 26, 2023, we closed a public offering of common stock and certain warrants for net proceeds of $4.1 million through the issuance
and sale of 1,306,250 shares of our common stock and, to certain investors, pre-funded warrants to purchase 1,537,500 shares of common
stock and accompanying common warrants to purchase up to an aggregate of 5,687,500 shares of our common stock. The public offering price
of each share of common stock (or pre-funded warrant in lieu thereof) and accompanying common warrant was $1.60.
Fiscal
Year Ended September 30, 2023 Financial Results
Jay
Cross, CFO, elaborated on Sonnet’s performance, saying, “We are very pleased with the progress we made this year in an otherwise
challenging environment for small biotechnology companies. We will continue to closely monitor our operating expenses, and we are happy
to share the preliminary approval we recently received to sell up to $4.8 million of our New Jersey state net operating losses.”
As
of September 30, 2023, Sonnet had no debt and $2.27 million cash on hand, which excludes net proceeds of $4.1 million from the October
financing. Sonnet believes its cash at September 30, 2023, together with the $4.1 million net proceeds from the October financing, will
fund its projected operations into March 2024. In addition, Sonnet expects to receive a $0.8 million net cash refund from the research
and development tax incentive program in Australia and recently received preliminary approval of its application to sell up to $4.8 million
of its New Jersey state net operating losses through the Technology Business Tax Certificate Transfer Program, subject to execution of
such sale, which together Sonnet believes will extend the funding of its projected operations into the third calendar quarter of 2024.
Research
and development expenses were $11.8 million for the year ended September 30, 2023, compared to $21.4 million for the year ended September
30, 2022. The decrease of $9.6 million was primarily due to the establishment of cost savings by transitioning product development activities
to cost advantaged locations such as India and Australia, by reducing expenditures on tertiary programs such as SON-3015, which has been
placed on a development hold, and suspending antiviral development related to SON-1010, as well as a decrease in share-based compensation
expense.
General
and administrative expenses were $7.1 million for the year ended September 30, 2023, compared to $8.6 million for the year ended September
30, 2022. The decrease of $1.5 million relates primarily to a decrease in share-based compensation, legal and business development expenses,
as we are managing expenses for liquidity purposes and are tightening our focus on the research and development projects we have assessed
to have the greatest near-term potential.
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.
Tecentriq®
(atezolizumab) is a registered trademark of Genentech, a member of the Roche Group.
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.
Sonnet
BioTherapeutics Investor Contact:
Jack
Yauch
Solebury
Strategic Communications
862-754-1024
jyauch@soleburystrat.com
Sonnet
BioTherapeutics Holdings, Inc.
Consolidated
Balance Sheets
| |
September 30, | |
| |
2023 | | |
2022 | |
Assets | |
| | | |
| | |
Current assets: | |
| | | |
| | |
Cash and cash equivalents | |
$ | 2,274,259 | | |
$ | 3,052,879 | |
Prepaid expenses and other current assets | |
| 1,677,396 | | |
| 1,643,743 | |
Income tax receivable | |
| 786,574 | | |
| 717,305 | |
Total current assets | |
| 4,738,229 | | |
| 5,413,927 | |
Property and equipment, net | |
| 33,366 | | |
| 46,211 | |
Operating lease right-of-use asset | |
| 193,689 | | |
| 256,594 | |
Deferred offering costs | |
| 49,988 | | |
| 113,280 | |
Other assets | |
| 414,206 | | |
| — | |
Total assets | |
$ | 5,429,478 | | |
$ | 5,830,012 | |
Liabilities and stockholders’ deficit | |
| | | |
| | |
Current liabilities: | |
| | | |
| | |
Related party notes | |
$ | — | | |
$ | 748 | |
Accounts payable | |
| 2,201,999 | | |
| 4,752,340 | |
Accrued expenses and other current liabilities | |
| 3,230,922 | | |
| 3,193,972 | |
Current portion of operating lease liability | |
| 73,048 | | |
| 51,328 | |
Deferred income | |
| 18,626 | | |
| 166,431 | |
Total current liabilities | |
| 5,524,595 | | |
| 8,164,819 | |
Operating lease liability, net of current portion | |
| 130,863 | | |
| 203,912 | |
Total liabilities | |
| 5,655,458 | | |
| 8,368,731 | |
Commitments and contingencies | |
| | | |
| | |
Stockholders’ deficit: | |
| | | |
| | |
Common stock, $0.0001 par value: 125,000,000 shares authorized; 1,750,426 and 251,955 issued and outstanding at September 30, 2023 and 2022, respectively | |
| 175 | | |
| 25 | |
Additional paid-in capital | |
| 110,017,598 | | |
| 88,872,315 | |
Accumulated deficit | |
| (110,243,753 | ) | |
| (91,411,059 | ) |
Total stockholders’ deficit | |
| (225,980 | ) | |
| (2,538,719 | ) |
Total liabilities and stockholders’ deficit | |
$ | 5,429,478 | | |
$ | 5,830,012 | |
See
10-K filed today for notes to consolidated financial statements
Sonnet
BioTherapeutics Holdings, Inc.
Consolidated
Statements of Operations
| |
Years ended September 30, | |
| |
2023 | | |
2022 | |
Collaboration revenue | |
$ | 147,805 | | |
$ | 349,943 | |
Operating expenses: | |
| | | |
| | |
Research and development | |
| 11,814,690 | | |
| 21,444,019 | |
General and administrative | |
| 7,125,732 | | |
| 8,575,283 | |
Total operating expense | |
| 18,940,422 | | |
| 30,019,302 | |
Loss from operations | |
| (18,792,617 | ) | |
| (29,669,359 | ) |
| |
| | | |
| | |
Foreign exchange loss | |
| (40,077 | ) | |
| (52,482 | ) |
Net loss | |
$ | (18,832,694 | ) | |
$ | (29,721,841 | ) |
Per share information: | |
| | | |
| | |
Net loss per share, basic and diluted | |
$ | (18.14 | ) | |
$ | (150.52 | ) |
Weighted average shares outstanding, basic and diluted | |
$ | 1,038,188 | | |
$ | 197,462 | |
See
10-K filed today for notes to consolidated financial statements
SOURCE:
Sonnet BioTherapeutics Holdings, Inc.
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