Sonnet BioTherapeutics provides – GuruFocus.com

  • SON-1010 and SON-080 on track to initiate clinical studies in Q2 2022
  • Completion of R&D manufacturing for the non-GLP toxicity study of SON-1210 in non-human primates, with study launch planned for the first half of 2022
  • Continue to advance the preclinical development of FHAB Pipeline
  • PRINCETON, NJ/ACCESSWIRE/February 8, 2022/ Sonnet BioTherapeutics Holdings, Inc. (NASDAQ:SONN) (“Sonnet” or the “Company”), a biopharmaceutical company developing innovative targeted biologic drugs, today announced its financial results for the three months ended December 31, 2021 and provided a trade update.

    “Throughout the quarter, we continued to move towards the clinic with our proprietary all-human albumin binding (FHAB) and our partner product, SON-080,” said Pankaj Mohan, Ph.D., Founder and CEO. “We continue to generate additional clinical product stability data for SON-1010 (IL12-FHAB) for the FDA and we initiated cGMP manufacturing for SON-080 (low dose IL-6), with both assets on track to start clinical studies in the second quarter of this year. Additionally, we have completed R&D manufacturing for a non-GLP toxicology study on non-human primates for SON-1210 (IL12-FHAB-IL15), with study initiation scheduled for the first half of 2022 and have made significant progress with our SON-1410 (IL18-FHAB-IL12) and SON-3015 (Anti-IL6-FHAB-Anti-TGFβ) bispecific actives.”

    “We remain pleased with our ongoing funding strategy and continue to provide the company with the funding needed to advance our R&D activities in the clinic and grow the business in 2022,” commented Jay Cross, Chief Financial Officer.

    First Quarter of Fiscal 2022 and Recent Company Updates

    Sonnet has provided the following corporate updates for calendar year 2022:

    • Generation of additional clinical product stability data for SON-1010 for the FDA in 1Q22; SON-1010 is on track for clinical study initiation in 2Q22.
    • Completion of preparations for cGMP manufacturing of SON-080, start of manufacturing in January and on track for the start of the clinical study in 2Q22.
    • Completed R&D manufacturing for SON-1210 with initiation of non-GLP preclinical toxicity study in non-human primates on track 1H22.
    • Confirmation of completed sequence for SON-3015 and preparation for premiere live mouse studies in 2H22.
    • Lead optimization is underway to initiate CMC with cell line development for SON-1410 at 2Q22.

    Financial results for the first quarter of fiscal 2022 ended December 31, 2021

    • As of December 31, 2021, Sonnet had $19.4 million in cash.
    • Research and development expenses were $4.3 million for the three months ended December 31, 2021, compared to $3.9 million for the three months ended December 31, 2020. The increase of $0.4 million dollars is primarily due to the development of cell lines for SON-1010, SON-1210 and SON-080, and an increase in payroll and stock-based compensation expenses as we continue to grow our business.
    • General and administrative expenses were $2.1 million for the three months ended December 31, 2021, compared to $2.0 million for the three months ended December 31, 2020. The increase of $0.1 million dollars is related to an increase in consulting fees.

    About Sonnet BioTherapeutics Holdings, Inc.

    Founded in 2011, Sonnet BioTherapeutics is an oncology-focused biotechnology company with a proprietary platform for innovative single- and bispecific-acting biologic drugs. Known as FHAB (Fully Human Albumin Binding), technology uses a fully human single-chain antibody fragment (scFv) that binds and “hitchhikes” to human serum albumin (HSA) for transport to the target tissues. FHAB is the basis for a plug-and-play modular construct to potentiate 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 the Private Securities Litigation Reform Act, as amended, including those relating to product development of the Company, clinical and regulatory timelines, market opportunities, competitive position, possible or anticipated future results of operations, business strategies, potential growth opportunities and other statements of a predictive nature. These forward-looking statements are based on current expectations, estimates, forecasts and projections about the industry and markets in which we operate, as well as management’s current beliefs and assumptions.

    These statements can be identified by the use of forward-looking expressions, including, but not limited to, “expect”, “anticipate”, “intend”, “plan”, “believe”. , “estimate”, “potential”, “predict”. ,” “plan”, “should”, “would” and similar expressions and the negatives of these terms. These statements relate to future events or our financial performance and involve known and unknown risks, uncertainties and other factors that 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.These 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 these forward-looking statements, which speak only as of the date of this press release. The Company undertakes no obligation to publicly update any statement. forward-looking, whether as a result of new information, future events or otherwise.

    Sonnet Biotherapeutics Investor Contact

    Michael V. Morabito, Ph.D.
    Solebury Trout
    917-936-8430
    [email protected]

    Sonnet BioTherapeutics Holdings, Inc.
    Consolidated balance sheets
    (unaudited)

    The 31st of December, September 30,
    2021 2021

    Assets

    Current assets:

    Cash

    $ 19,409,718 $ 27,622,067

    Prepaid expenses and other current assets

    1,174,027 1,189,474

    Total current assets

    20,583,745 28,811,541

    Property and equipment, net

    55,844 59,056

    Operating lease right-of-use asset

    100,978 123 213

    Total assets

    $ 20,740,567 $ 28,993,810

    Liabilities and equity

    Current liabilities:

    Related party notes

    $ 748 $ 748

    Accounts payable

    2,112,287 3,781,299

    Increased expenses

    1,747,116 2,310,410

    Operating lease liability

    97,902 94,520

    Deferred revenue

    386,575 516,374

    Total current liabilities

    4,344,628 6,703,351

    Operating lease liability

    4,998 30,612

    Total responsibilities

    4,349,626 6,733,963

    Commitments and contingencies

    Equity:

    Preferred stock; Par value of $0.0001: 5,000,000 shares authorized. No shares issued or outstanding

    Ordinary actions; face value of $0.0001: 125,000,000 shares authorized; 60,250,637 issued and outstanding as of December 31, 2021 and September 30, 2021

    6,025 6,025

    Premium

    84 275 115 83,943,040

    Accumulated deficit

    (67,890,199 ) (61,689,218 )

    Full shareholder equity

    16,390,941 22,259,847

    Total Liabilities and Equity

    $ 20,740,567 $ 28,993,810

    See 10-Q filed today for notes to consolidated financial statements

    Sonnet BioTherapeutics Holdings, Inc.
    Consolidated Statements of Income
    (unaudited)

    2021 2020
    Quarter ended December 31
    2021 2020

    Collaboration revenue

    $ 129,799 $

    Operating costs :

    Research and development

    4,265,866 3,866,007

    general and administrative

    2,078,885 1,997,986

    Total operating expenses

    6,344,751 5,863,993

    Operating loss

    (6,214,952 ) (5,863,993 )

    Foreign exchange gain (loss)

    13,971 (13,247 )

    Net loss

    $ (6,200,981 ) $ (5,877,240 )

    Information per share:

    Net loss per share, basic and diluted

    $ (0.10 ) $ (0.34 )

    Weighted average number of shares outstanding, basic and diluted

    60 293 010 17,218,485

    See 10-Q filed today for notes to consolidated financial statements

    THE SOURCE: Sonnet BioTherapeutics, Inc.

    See the source version on accesswire.com:
    https://www.accesswire.com/687700/Sonnet-BioTherapeutics-Provides-Fiscal-Year-2022-First-Quarter-Business-and-Earnings-Update

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