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British Medical Journal Open publishes paper detailing the results of the international Phase II human trial for LSALT peptide targeting acute lung and kidney inflammation in hospitalized patients infected with SARS-CoV-2 virusPhase II findings previously disclosed support dipeptidase-1 (DPEP-1) as a relevant therapeutic target for diseases of the lung, kidneys and liver where inflammation plays a major role. New biomarker data from the pandemic Phase II trial, provides further scientific rationale for Arch to bring LSALT peptide into larger trials to inhibit DPEP-1 mediated organ inflammation. Arch is currently performing a Phase II human trial to support LSALT peptide as a first ever treatment for preventing cardiac surgery-associated acute kidney injury. TORONTO, March 18, 2024 (GLOBE NEWSWIRE) -- Arch Biopartners Inc., (“Arch” or the “Company”) (TSX Venture: ARCH and OTCQB: ACHFF), announced today that it has published a peer reviewed paper in the British Medical Journal Open (BMJ Open) detailing the results of the international Phase II human trial for LSALT peptide targeting acute lung and kidney inflammation in hospitalized patients infected with SARS-CoV-2 virus. LSALT peptide is a DPEP-1 inhibitor and the Company’s lead drug candidate for preventing and treating inflammation injury in the kidneys, lungs, and liver. The paper in BMJ Open describes the clinical highlights, outcomes and biomarker results of the study. The Phase II trial was an international, multicenter, randomized, double-blind, placebo-controlled, proof of concept study of LSALT peptide for the prevention of organ inflammation such as acute respiratory distress syndrome (ARDS) and acute kidney injury (AKI) in patients infected with SARS-CoV-2. The exploratory, adaptive trial was initiated in the early stages of the global pandemic to identify clinical signals of efficacy for LSALT peptide in the treatment of acute lung and kidney inflammation. The results of the Phase II trial provided first-ever evidence validating DPEP-1 as a mediator of organ inflammation and therapeutic target in humans. In addition, LSALT peptide was well tolerated with no safety issues related to the drug. New biomarker data for LSALT peptide was disclosed for the first time in the BMJ Open publication. An analysis of serum inflammatory biomarkers was performed from blood samples collected from study participants. Biomarkers analyzed which relate to organ inflammation included cytokines and chemokines such as IL-6, CXCL8, CXCL10, IL-1β and CCL7. Collectively, a greater proportion of inflammatory biomarkers decreased in patients receiving LSALT peptide compared with placebo. In particular, the reduction of CXCL10 in the LSALT peptide group versus the placebo group was statistically significant at the end of treatment. CXCL10 plays a role in facilitating leukocyte recruitment to various vascular beds including the lungs and kidneys. The reduction of CXCL10 and the other inflammatory biomarkers during LSALT peptide treatment is consistent with LSALT peptide’s mechanism of action as an inhibitor of DPEP-1 mediated leukocyte recruitment to the lungs and kidneys. The new data provides more scientific rationale for Arch to advance LSALT peptide to prevent leukocyte recruitment and organ inflammation for other indications, including a larger Phase II trial targeting cardiac surgery-associated AKI, which recently began recruiting patients. More information on the current trial can be found below and at clinicaltrials.gov Details of the results from the Phase II trial are reported in the peer-reviewed journal BMJ Open. The publication, titled “Multicenter, Randomized, Double-Blind, Placebo-Controlled, Proof of Concept Study of LSALT Peptide as Prevention of Acute Respiratory Distress Syndrome and Acute Kidney Injury in Patients Infected with SARS-CoV-2 (COVID-19)” by Somayaji et. al. can be found at the BMJ Open website. Quote from Richard Muruve, CEO of Arch Biopartners Inc.: “When the pandemic started and hospitals were filling up with patients with respiratory distress caused by inflammation, we postponed our plans to do a CS-AKI trial to urgently perform a Phase II trial to treat hospitalized COVID patients and reduce acute organ inflammation. Now that we have published our biomarker and clinical data from the trial, we are more confident today that inhibiting DPEP-1 mediated leukocyte recruitment to the kidneys, lungs and liver is a valid path toward first-ever treatments to prevent acute injury in these organs.” About the Phase II trial for LSALT Peptide in Pandemic Patients The Phase II trial was an international, multicenter, randomized, double-blind, placebo-controlled, proof of concept study of LSALT peptide for the prevention of organ inflammation such as acute respiratory distress syndrome (ARDS) and acute kidney injury (AKI) in patients infected with SARS-CoV-2. Six clinical sites located in Canada, United States, and Turkey participated in the Phase II trial in 2021. The composite primary endpoint of the Phase II trial reflected the severe effects often experienced by hospitalized patients in the early months of the pandemic and deemed appropriate for LSALT peptide’s novel mechanism of action in blocking consequential inflammation in the lungs, kidneys, and other organs. The exploratory study was designed to detect a clinical signal of efficacy and was not powered for statistical significance. Previously disclosed in December 2021 and included in the BMJ Open publication, there were no significant differences in adverse events between LSALT peptide and placebo treated patients. The study population of the Phase II trial did not have enough incidence of ARDS or AKI to detect a conclusion on these two particular clinical outcomes. In a secondary evaluation of patients on ventilation, despite being older by an average of 5 years, subjects in the LSALT peptide group demonstrated 22.8 ventilation-free days compared to 20.9 days in the placebo group in the unadjusted analysis at 28 days. “Ventilation” was defined as a need for high flow oxygen therapy (≥ 6L/min), non-invasive ventilation, mechanical ventilation, or extracorporeal membrane oxygenation (ECMO). In a post-hoc analysis adjusting for age, body mass index (BMI), and PaO2/FiO2 ratio (a measure of lung disease severity), the difference in ventilation-free days was 6.7 days favoring the LSALT peptide group compared to the placebo group. About Phase II trial for LSALT Peptide targeting CS-AKI Arch Biopartners is currently sponsoring a Phase II trial for LSALT peptide targeting cardiac surgery-associated acute kidney injury (CS-AKI). CS-AKI is often caused by ischemia-reperfusion injury (IRI) that reduces blood flow (ischemia) and thus oxygen in the kidney causing kidney cell damage. Once blood flow is restored to normal (reperfusion), inflammation is triggered and injury to kidney cells is exacerbated. In the worst cases of AKI, kidneys fail, leading to kidney dialysis or kidney transplant. At present, there are no therapeutic treatments available to prevent or treat CS-AKI or IRI. The CS-AKI Phase II trial is an international multi-center, randomized, double-blind, placebo-controlled study of LSALT peptide. The recruitment target for the trial is 240 patients. The primary objective of the trial is to evaluate the percentage of subjects with AKI within seven days following on-pump (heart-lung machine) cardiac surgery, defined by the KDIGO (Kidney Disease: Improving Global Outcomes) criteria. Details of the Phase II trial, entitled “Phase 2 Global, Multicenter, Randomized, Double-Blind, Placebo-Controlled Study of LSALT peptide for the Prevention or Attenuation of Acute Kidney Injury (AKI) in Patients Undergoing On-Pump Cardiac Surgery” can be viewed at clinicaltrials.gov. Recruitment of patients in the CS-AKI trial has begun in three hospital sites in Turkey with a hospital in Canada (University of Calgary) joining the trial last week. Additional sites are expected to be added in Turkey and Canada in the next few weeks. About LSALT Peptide LSALT peptide is a novel peptide drug candidate and DPEP-1 inhibitor. In August 2019, a scientific team led by Arch scientists Dr. Donna Senger and Dr. Stephen Robbins published a paper in the journal Cell describing a novel mechanism of action for organ inflammation. In the publication, DPEP-1 was identified, for the first time, as a major leukocyte (white blood cell) adhesion receptor on the lung, liver and kidney endothelium. DPEP-1 was also identified as the target of LSALT peptide, differing from typical anti-inflammatory drugs by targeting this novel adhesion receptor rather than targeting individual cytokines, of which there are many. The Cell publication, titled “Dipeptidase-1 is an adhesion receptor for neutrophil recruitment in lungs and liver” by Choudhry et. Al. can be found at the Cell journal’s website. LSALT peptide has been shown by Arch scientists and their collaborators to prevent ischemia-reperfusion injury to the kidneys in pre-clinical models (Video Link to pre-clinical proof of concept). Details of their findings were published in a Science Advances publication, titled “Dipeptidase-1 governs renal inflammation during ischemia reperfusion injury” by Lau et. al. and can be found at the Science Advances website. About Arch Biopartners Arch Biopartners Inc. is a late-stage clinical trial company focused on preventing inflammation and acute organ injury. The Company is developing new drug candidates that inhibit inflammation in the lungs, kidneys, and liver via the dipeptidase-1 (DPEP-1) pathway and are relevant for common injuries and diseases where organ inflammation is an unmet problem. For more information on Arch Biopartners' science and technologies, please visit: www.archbiopartners.com/our-science For investor information and other public documents the company has also filed on SEDAR+, please visit www.archbiopartners.com/investor-hub The Company has 62,755,633 common shares outstanding. Forward-Looking Statements This press release contains forward-looking statements within the meaning of applicable Canadian securities laws regarding expectations of our future performance, liquidity and capital resources, as well as the ongoing clinical development of our drug candidates targeting the dipeptidase-1 (DPEP-1) pathway, including the outcome of our clinical trials relating to LSALT peptide (Metablok), the successful commercialization and marketing of our drug candidates, whether we will receive, and the timing and costs of obtaining, regulatory approvals in Canada, the United States, Europe and other countries, our ability to raise capital to fund our business plans, the efficacy of our drug candidates compared to the drug candidates developed by our competitors, our ability to retain and attract key management personnel, and the breadth of, and our ability to protect, our intellectual property portfolio. These statements are based on management’s current expectations and beliefs, including certain factors and assumptions, as described in our most recent annual audited financial statements and related management discussion and analysis under the heading “Business Risks and Uncertainties”. As a result of these risks and uncertainties, or other unknown risks and uncertainties, our actual results may differ materially from those contained in any forward-looking statements. The words “believe”, “may”, “plan”, “will”, “estimate”, “continue”, “anticipate”, “intend”, “expect” and similar expressions are intended to identify forward-looking statements, although not all forward-looking statements contain these identifying words. We undertake no obligation to update forward-looking statements, except as required by law. Additional information relating to Arch Biopartners Inc., including our most recent annual audited financial statements, is available by accessing the Canadian Securities Administrators’ System for Electronic Document Analysis and Retrieval (“SEDAR”) website at www.sedarplus.ca . The science and medical contents of this release have been approved by the Company’s Chief Science Officer Neither TSX Venture Exchange nor its Regulation Services Provider (as that term is defined in the policies of the TSX Venture Exchange) accepts responsibility for the adequacy or accuracy of this release

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. View the original press release on accesswire.com

Findings show non-pharmacological approaches may be beneficial for postmenopausal women ROSEVILLE, Calif., Dec. 12, 2023 /PRNewswire/ -- A new study published in The Journal of Nutrition shows daily consumption of prunes may reduce inflammation markers connected to bone signaling pathways and reduce the effects of bone loss among postmenopausal women. "Bone loss is a significant issue impacting more than 50% of women over the age of 50, and there is no cure," said Principal Investigator Mary Jane De Souza, PhD, Professor, Department of Kinesiology, Pennsylvania State University. "While medications and hormone therapies are available, they often require lifelong management and come with risks. It's important to have a better understanding of how non-pharmacological approaches – like lifestyle and dietary choices—can also impact the progression and mitigation of bone loss." The new study's findings show significant reductions in inflammatory cytokines, which are proteins that help control inflammation, and activated monocytes, which are a major type of immune cell that has been shown to drive the chronic inflammatory response, when 50 to 100 grams of prunes (about 5-12 prunes) are included in the diet, daily. Specifically, reductions were seen in Tumor Necrosis Factor-α following 50 grams of daily prune intake, and reductions in Interleukin-1β, Interleukin-6, Interleukin-8 secretions, as well as activated monocytes, with 100 grams of prune intake, compared to diets without prunes. "These findings may be attributed to the abundance of bioactive compounds found in prunes, including vitamins, minerals, phenolic acids and polyphenols, which are likely acting synergistically to suppress activated monocytes and their secretion of bone-resorptive inflammatory cytokines," said Co-author Connie Rogers, PhD, MPH, Professor and Department Head, Department of Nutritional Sciences, University of Georgia. This is an ancillary study of a larger, single-center, parallel-arm, 12-month randomized control trial1 (PRUNE study). The PRUNE study aimed to explore immune, inflammatory and oxidative stress markers related to the bone-protective effects of prunes in nonsmoking and not severely obese postmenopausal women, aged 55-75 years who refrained from phenolic supplements or large amounts of phenolic-containing fruit (apples and blueberries) for at least 2 months prior to the start of the study. This investigation was completed by 183 participants who were split into three groups: control/no prunes (n=70), 50 grams/day prunes (n=67) and 100 grams/day prunes (n=46). After a run-in period, participants followed the prune protocol for a total of 12-months and were instructed to record the days and number of prunes eaten in a daily log, used to monitor compliance. Participants were considered compliant if they consumed more than 80% of their prescribed treatment, and all participants consumed more 90% of their prescribed treatment. Measurements of immune, inflammatory and oxidative stress markers were taken at baseline and at the end of the 12-month intervention. Beyond the prune intake protocols, all participants received a daily dose of calcium and vitamin D3 to meet the recommended dietary allowance of 1200 mg of calcium and 800 IU vitamin D3 daily from diet plus supplements, and they followed a free-living diet. "These findings add to a growing body of research and interest investigating the role of 'food as medicine' and complement other studies I have conducted using the same data," De Souza said. "For example, a previous study2 I led showed connections between hip bone integrity and daily consumption of prunes—where postmenopausal women who did not eat prunes lost 1.5% of their hip bone density compared to women who ate 5-6 prunes daily. Collectively, these findings have significant practical importance given the prevalence of bone loss among this population." "Our investment in the PRUNE study has led to many key publications and novel findings that can help improve public health and the understanding of the role foods may play in disease prevention and management," said Donn Zea, executive director, California Prune Board. "We are deeply committed to the scientific rigor of our nutrition research program which provides a license to communicate how enjoying California Prunes can have an effect on health outcomes." For about 100 calories, a serving of 4-6 California Prunes is a nutrient-dense superfood providing more than 20 different vitamins, minerals and plant compounds to the diet. As a premium dried fruit enjoyed across cultures and ethnicities, research into California Prunes' health benefits contributes to a better understanding of their role as a dietary tool to promote health and potentially lower chronic disease risk. ABOUT THE CALIFORNIA PRUNE BOARD The California Prune Board was established in 1952 to represent growers and handlers under the authority of the California Secretary of Food and Agriculture. California is the world's largest producer of prunes with orchards across 14 counties in the Sacramento and San Joaquin valleys. Promoting a lifetime of wellness through the enjoyment of California Prunes, the organization leads the premium prune category with generations of craftsmanship supported by California's leading food safety and sustainability standards. California Prunes. Prunes. For life. 1 De Souza MJ, Strock NCA, Williams NI, Lee H, Koltun KJ, Rogers C, Ferruzzi MG, Nakatsu CH, Weaver C. Prunes preserve hip bone mineral density in a 12-month randomized controlled trial in postmenopausal women: the Prune Study. Am J Clin Nutr. 2022 Oct 6;116(4):897-910. 2 De Souza MJ, Strock NCA, Williams NI, Lee H, Koltun KJ, Rogers C, Ferruzzi MG, Nakatsu CH, Weaver C. Prunes preserve hip bone mineral density in a 12-month randomized controlled trial in postmenopausal women: the Prune Study. Am J Clin Nutr. 2022 Oct 6;116(4):897-910. doi: 10.1093/ajcn/nqac189. PMID: 35798020. Contact: Amber Gray [email protected] 407-948-1560 SOURCE California Prune Board