Form DEFA14A - Additional definitive proxy soliciting materials and Rule 14(a)(12) material
2023年8月22日 - 9:30PM
Edgar (US Regulatory)
UNITED
STATES
SECURITIES
AND EXCHANGE COMMISSION
Washington,
D.C. 20549
SCHEDULE
14A
PROXY
STATEMENT PURSUANT TO SECTION 14(A)
OF
THE SECURITIES EXCHANGE ACT OF 1934 (Amendment No. )
Filed
by the Registrant ☒
Filed
by a party other than the Registrant ☐
Check
the appropriate box:
☐ |
Preliminary Proxy Statement |
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Confidential, for Use of
the Commission Only (as permitted by Rule 14a-6(e)(2)) |
☐ |
Definitive Proxy Statement |
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Definitive Additional Materials |
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Soliciting Material under
§ 240.14a-12 |
SONNET
BIOTHERAPEUTICS HOLDINGS, INC.
(Name
of Registrant as Specified In Its Charter)
(Name(s)
of Person(s) Filing Proxy Statement, if other than the Registrant)
Payment
of Filing Fee (Check all boxes that apply):
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No fee required. |
|
|
☐ |
Fee paid previously with
preliminary materials. |
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Fee computed on table in
exhibit required by Item 25(b) per Exchange Act Rules 14a-6(i)(1) and 0-11. |
On
August 22, 2023, Sonnet BioTherapeutics Holdings, Inc. sent the following letter to its stockholders:
Dear Sonnet Shareholders, |
August 22, 2023 |
I
wanted to connect with our shareholders to provide a business update and discuss future opportunities for our assets. Since our last
shareholder meeting in September 2022, Sonnet has focused on business development, which we believe sets the stage for two potential
partnership opportunities that have been previously disclosed with Roche and Janssen, on immune checkpoint inhibitors and cell-based
therapies, respectively.
1)
The immune checkpoint inhibitors (ICIs) represent an extremely successful class of cancer therapies with close to $40 billion in
reported combined 2022 annual revenue for certain large pharmaceutical players, such as Merck, Bristol-Myers, Roche, Astra Zeneca,
Pfizer, and others. There is a significant industry initiative to enhance these ICIs with immune-activators/stimulators. However,
the toxicity associated with several immune activators in combination with that of the ICIs creates a potential impediment to
commercial approval. We believe Sonnet’s platform, which offers a longer half-life and solid tumor targeting/retention, could
enable commercialization of an ICI combination, especially in cancer indications where the ICIs have not been very effective, such
as with platinum-resistant ovarian cancer (PROC). We are collaborating with Roche to evaluate this combination in the clinic for
PROC. As you are aware, the trial was accepted by the Australian regulatory agency earlier this year and more recently, the FDA
accepted the IND to begin clinical study in the US. We expect to see the first safety data within the next few quarters.
2)
Cell-based therapy is another important advancement in medical oncology, where the patient’s isolated T-cells are genetically
engineered to fight cancer. Based on a number of publications, immune-activators have a significant role to play, especially for
solid tumors. Sonnet is collaborating with Janssen to evaluate SON-1010, SON-1210, and SON-1410 with Janssen’s CAR-T
cell-based therapy. We expect data to be available in the next few quarters.
Sonnet’s
proprietary technology, the “Fully Human Albumin Binding” (FHAB) domain, was designed to target solid tumors, to be retained
in the tumor microenvironment (TME) and to extend drug half-life. SON-1010, our lead drug candidate that presents IL-12 on our FHAB platform,
is a powerful immune-enhancer that we believe offers a differentiated approach for the therapeutic application of this cytokine. Sonnet
carefully evaluated responses to SON-1010 dosing in both normal healthy volunteers and cancer patients. The preliminary data that we
previously shared with you demonstrates potential targeting of tumor tissue in cancer patients, along with a long half-life and early
clinical benefit. SON-1210 is our first bifunctional candidate that integrates IL-12 and an additional immunomodulatory cytokine, IL-15.
Together, these two cytokines exhibited synergies in preclinical cancer models and we have shown its safety in GLP toxicology studies.
Furthermore, we have successfully manufactured SON-1210 and we believe we are ready to begin the regulatory preparations to enter the
clinic. The molecule is currently under evaluation by Janssen as part of its engineered cell-based programs. This asset is followed by
SON 1410, another bifunctional FHAB candidate comprising IL-18 and IL-12, which is also under evaluation by Janssen. Finally, SON-080,
which is a low-dose version of fully human IL-6 that we in-licensed, is currently undergoing clinical testing in chemotherapy-induced
peripheral neuropathy (CIPN). This candidate has been progressing in the clinic, though somewhat slowly due to patient recruitment challenges.
There remains persistent unmet medical need in both CIPN and the potentially much larger indication of diabetic peripheral neuropathy
(DPN), which are important drivers of our decision to continue to pursue development in these indications.
We
are excited about advancing our collaborations and the potential partnerships that could generate important data sets within the next
fiscal year and which, if successful, we believe represent an opportunity to bring non-dilutive capital into the company. Further, we
have significantly reduced the operating expenses to focus on assets with near-term partnering interest as we navigate through a tough
financial market while maintaining our Nasdaq listing. We understand your concerns about dilutive financings, and we are working diligently
to capitalize the company as efficiently as possible. Together, let us advance our initiative of innovating groundbreaking new cancer
therapies and I look forward to interacting with you in our 2023 Annual Shareholder meeting on August 31.
Sincerely,
Pankaj
Mohan, Ph.D., MBA
Founder
& CEO
Sonnet
BioTherapeutics
Sonnet BioTherapeutics (NASDAQ:SONN)
過去 株価チャート
から 4 2024 まで 5 2024
Sonnet BioTherapeutics (NASDAQ:SONN)
過去 株価チャート
から 5 2023 まで 5 2024