On December 17, 2021 Antengene Corporation Limited (the "Company" or "Antengene") reported that ATG-010 (selinexor, brand name: XPOVIO), a first-in-class, oral Selective Inhibitor of Nuclear Export (SINE) compound has received conditional approval for marketing by the National Medical Products Administration (the "NMPA"), applicable in combination with dexamethasone for the treatment of adults with relapsed or refractory multiple myeloma (RRMM) who have received prior therapy including a proteasome inhibitor, an immunomodulatory agent and an anti-CD38 monoclonal antibody. XPOVIO is China’s first approved XPO1 inhibitor (Press release, Antengene, DEC 17, 2021, View Source [SID1234597380]). The conditional approval of XPOVIO was based on the global Phase 2 STORM trial as well as the positive results from the Phase 2 MARCH trial. The ongoing, randomized Phase 3 BENCH study in China, evaluating selinexor in combination with bortezomib and low-dose dexamethasone for patients with multiple myeloma as early as first relapse, will serve as the confirmatory trial.

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Antengene will host conference calls for investors on December 20, 2021 (China Standard Time).

Dr. Jay Mei, M.D., Ph.D., Chairman and Chief Executive Officer of Antengene commented, "Our mission is to bring first-in-class/best-in-class medicines to the market for patients with cancer and other life-threatening diseases. I am pleased that XPOVIO is Antengene’s first product to be approved in China and the first and only XPO1 inhibitor on the market in China."

Dr. Mei continued, "We believe the approval of XPOVIO will bring important clinical benefits to Chinese patients with refractory or relapsed multiple myeloma. XPOVIO is approved in three indications in the U.S., including in second line multiple myeloma, and the product has been widely adopted into practice guidelines by major oncology networks including the Chinese Society of Clinical Oncology (CSCO) in China, the National Comprehensive Cancer Network (NCCN) in the U.S. and the European Society for Medical Oncology (ESMO) (Free ESMO Whitepaper) in the EU. These are very positive steps to enabling product acceptance and adoption."

Dr. Kevin Lynch, M.D., Chief Medical Officer of Antengene commented, "With XPOVIO’s approval in China, Antengene can offer a new, much needed therapeutic option to Chinese patients with RRMM. We believe selinexor has broad potential in oncology and are committed to advance further development of the product though our program of 10 clinical studies in China. These include the confirmatory Phase 3 BENCH study for multiple myeloma patients after at least one prior therapy, as well as studies in other oncology indications that have strong relevance for patients in China."

Dr. Lynch continued, "Antengene would like to thank all of the patients and investigators involved in the clinical study and the NMPA for their support during the priority review. Together, we are aiming to improve the care and lives of people with cancer in China and around the world."

Antengene Conference Call Details

Antengene management will hold conference calls on Monday, December 20, 2021 to discuss the approval in China of ATG-010/XPOVIO:

Pivotal STORM and MARCH Trials

The conditional approval of XPOVIO was based on results from the global Phase 2 STORM trial as well as the Phase 2 MARCH trial in China evaluating the efficacy and safety of selinexor plus dexamethasone in 82 patients with relapsed/refractory multiple myeloma (RRMM).

Results of the STORM trial showed that the overall response rate (ORR), the primary endpoint, as assessed by an Independent Review Committee (IRC), based on the International Myeloma Working Group (IMWG) Uniform Response Criteria, was 25.3% for the prespecified subgroup of 83 patients whose disease was refractory to bortezomib, carfilzomib, lenalidomide, pomalidomide, and daratumumab.

Results of the MARCH trial showed that the efficacy and safety in Chinese patients whose disease was refractory to both lenalidomide and bortezomib, as well as the last line of therapy (with some also refractory to anti-CD38 monoclonal antibody), were generally consistent with that seen in the global study. The overall response rate, the primary endpoint, as assessed by an Independent Review Committee (IRC), was 29.3%, for all treated patients in the MARCH trial and 25% for patients refractory to at least a proteasome inhibitor, an immunomodulatory agent and an anti-CD38 antibody.

The ongoing, randomized Phase 3 BENCH study evaluating selinexor in combination with bortezomib and low-dose dexamethasone will serve as the confirmatory trial.

About the SINE Compounds

SINE (Selective Inhibitor of Nuclear Export) compounds are inhibitors of the major nuclear export protein Exportin 1 (XPO1). Currently, there are three oral SINE compounds, ATG-010 (selinexor), ATG-016 (eltanexor), and ATG-527 (verdinexor), under clinical development. Antengene has an exclusive license from Karyopharm Therapeutics Inc. ("Karyopharm") to these compounds in certain APAC markets.

About ATG-010/Selinexor/ XPOVIO

Selinexor is the first and only oral XPO1 inhibitor approved by the U.S. Food and Drug Administration (FDA). By blocking the nuclear export protein XPO1, selinexor can promote the intranuclear accumulation and activation of tumor suppressor proteins and growth regulating proteins, and down-regulate the levels of multiple oncogenic proteins. This induces apoptosis without affecting normal cells. Due to its novel mechanism of action, selinexor is being evaluated for use in multiple combination regimens to improve treatment efficacy.

Selinexor is approved by the U.S. FDA for the treatment of relapsed/refractory multiple myeloma (RRMM), second line multiple myeloma and relapsed/refractory diffuse large B–cell lymphoma.

Antengene obtained approval of selinexor in South Korea through a priority review process prior to the current approval by NMPA in China. Antengene is conducting 10 studies with selinexor in mainland China (3 in collaboration with Karyopharm) for relapsed/refractory/advanced hematological malignancies and advanced solid tumors.

On December 17, 2021 TRANSGENE (Paris:TNG) reported that Management will participate in the upcoming investor events set out below (Press release, Transgene, DEC 17, 2021, View Source [SID1234597379]).

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Transgene will meet institutional investors at the 11th Annual LifeSci Advisors Corporate Access Event (virtual event) from January 5th to 7th, 2022.

The Company will also attend:

25th ODDO BHF Digital Forum (virtual): January 6, 7, 10 and 11, 2022
Biotech Showcase Investor Conference (virtual):
January 10 to 12, 2022, in conjunction with the J.P. Morgan Healthcare conference
January 17 to 19, 2022
Biomed Event (Paris): January 26, 2022

On December 17, 2021 EMD Serono, the Healthcare business sector of Merck KGaA, Darmstadt, Germany in the US and Canada, reported that the Committee for Medicinal Products for Human Use (CHMP) of the European Medicines Agency (EMA) adopted a positive opinion recommending approval of once-daily oral TEPMETKO (tepotinib) as monotherapy for the treatment of adult patients with advanced non-small cell lung cancer (NSCLC) harboring alterations leading to mesenchymal-epithelial transition factor gene exon 14 (METex14) skipping, who require systemic therapy following prior treatment with immunotherapy and/or platinum-based chemotherapy (Press release, EMD Serono, DEC 17, 2021, View Source [SID1234597378]). The CHMP positive opinion will now be reviewed by the European Commission (EC), with a decision expected in the first quarter of 2022.

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"TEPMETKO has demonstrated important clinical benefits and a manageable safety profile in the treatment of this aggressive form of lung cancer, and has the potential to advance the treatment of this type of tumor," said Danny Bar-Zohar, M.D., Global Head of Development for the Healthcare business of Merck KGaA, Darmstadt, Germany. "We look forward to the European Commission decision, and bringing the first oral MET inhibitor in NSCLC to patients in Europe."

The positive opinion is based on results from the pivotal Phase II VISION study evaluating TEPMETKO as a once-daily oral monotherapy treatment for patients with advanced NSCLC with METex14 skipping alterations. Data from the primary analysis of the VISION study were previously published in The New England Journal of Medicine, and showed TEPMETKO demonstrated consistent and durable responses in both treatment naïve and previously treated adult patients with advanced NSCLC harboring alterations leading to METex14 skipping. Additional data from the VISION study presented at IASLC 2021 World Conference on Lung Cancer include results for 123 patients from Cohort C with follow-up of at least 3 months from the start of treatment and provide additional evidence supporting the clinically meaningful responses demonstrated in the primary analysis.1

In Europe, lung cancer is estimated to be the second most common cancer, and the leading cause of cancer-related mortality, responsible for 388,000 deaths in 2018.2 Alterations of the MET signaling pathway, including METex14 skipping alterations, are found in 3% to 4% of NSCLC cases, and are associated with having advanced disease and poor prognosis.1,3-6

TEPMETKO was the first oral MET inhibitor to receive a regulatory approval anywhere in the world for the treatment of advanced NSCLC harboring MET gene alterations, with its approval in Japan in March 2020. In February 2021, the U.S. Food and Drug Administration granted accelerated approval to TEPMETKO, making it the first and only once-daily oral MET inhibitor approved for patients in the U.S. with metastatic NSCLC with METex14 skipping alterations. This indication is approved under accelerated approval based on overall response rate and duration of response. Continued approval for this indication may be contingent upon verification and description of clinical benefit in confirmatory trials. Tepotinib is available in a number of countries, and under review by various other regulatory authorities globally. To meet an urgent clinical need, tepotinib is also available in a pilot zone of China in line with the government policy to drive early access for innovative medicines approved outside of China.

About VISION Study
VISION (NCT02864992) is an ongoing pivotal Phase II, multicenter, multi-cohort, single-arm, non-randomized, open-label study investigating tepotinib as monotherapy in 275 patients with a median age of 72.6 years with advanced or metastatic NSCLC with METex14 skipping alterations.

About TEPMETKO (tepotinib)
TEPMETKO is an oral MET inhibitor that inhibits the oncogenic MET receptor signaling caused by MET (gene) alterations. Discovered and developed in-house at Merck KGaA, Darmstadt, Germany, TEPMETKO has a highly selective mechanism of action, with the potential to improve outcomes in aggressive tumors that have a poor prognosis and harbor these specific alterations.

Merck KGaA, Darmstadt, Germany is also investigating the potential role of tepotinib in treating patients with NSCLC and acquired resistance due to MET amplification in the Phase II INSIGHT 2 study of tepotinib in combination with osimertinib in MET amplified, advanced or metastatic NSCLC harboring activating EGFR mutations that has progressed following first-line treatment with osimertinib.

Important Safety Information from the US FDA-Approved Label
TEPMETKO can cause interstitial lung disease (ILD)/pneumonitis, which can be fatal. Monitor patients for new or worsening pulmonary symptoms indicative of ILD/pneumonitis (eg, dyspnea, cough, fever). Immediately withhold TEPMETKO in patients with suspected ILD/pneumonitis and permanently discontinue if no other potential causes of ILD/pneumonitis are identified. ILD/pneumonitis occurred in 2.2% of patients treated with TEPMETKO, with one patient experiencing a Grade 3 or higher event; this event resulted in death.

TEPMETKO can cause hepatotoxicity, which can be fatal. Monitor liver function tests (including ALT, AST, and total bilirubin) prior to the start of TEPMETKO, every 2 weeks during the first 3 months of treatment, then once a month or as clinically indicated, with more frequent testing in patients who develop increased transaminases or total bilirubin. Based on the severity of the adverse reaction, withhold, dose reduce, or permanently discontinue TEPMETKO. Increased alanine aminotransferase (ALT)/increased aspartate aminotransferase (AST) occurred in 13% of patients treated with TEPMETKO. Grade 3 or 4 increased ALT/AST occurred in 4.2% of patients. A fatal adverse reaction of hepatic failure occurred in one patient (0.2%). The median time-to-onset of Grade 3 or higher increased ALT/AST was 30 days (range 1 to 178).

TEPMETKO can cause embryo-fetal toxicity. Based on findings in animal studies and its mechanism of action, TEPMETKO can cause fetal harm when administered to a pregnant woman. Advise pregnant women of the potential risk to a fetus. Advise females of reproductive potential or males with female partners of reproductive potential to use effective contraception during treatment with TEPMETKO and for one week after the final dose.

Avoid concomitant use of TEPMETKO with dual strong CYP3A inhibitors and P-gp inhibitors and strong CYP3A inducers. Avoid concomitant use of TEPMETKO with certain P-gp substrates where minimal concentration changes may lead to serious or life-threatening toxicities. If concomitant use is unavoidable, reduce the P-gp substrate dosage if recommended in its approved product labeling.

Fatal adverse reactions occurred in one patient (0.4%) due to pneumonitis, one patient (0.4%) due to hepatic failure, and one patient (0.4%) due to dyspnea from fluid overload.

Serious adverse reactions occurred in 45% of patients who received TEPMETKO. Serious adverse reactions in >2% of patients included pleural effusion (7%), pneumonia (5%), edema (3.9%), dyspnea (3.9%), general health deterioration (3.5%), pulmonary embolism (2%), and musculoskeletal pain (2%).

The most common adverse reactions (≥20%) in patients who received TEPMETKO were edema, fatigue, nausea, diarrhea, musculoskeletal pain, and dyspnea.

Clinically relevant adverse reactions in <10% of patients who received TEPMETKO included ILD/pneumonitis, rash, fever, dizziness, pruritus, and headache.

Selected laboratory abnormalities (≥20%) from baseline in patients receiving TEPMETKO in descending order were: decreased albumin (76%), increased creatinine (55%), increased alkaline phosphatase (ALP) (50%), decreased lymphocytes (48%), increased alanine aminotransferase (ALT) (44%), increased aspartate aminotransferase (AST) (35%), decreased sodium (31%), decreased hemoglobin (27%), increased potassium (25%), increased gamma-glutamyltransferase (GGT) (24%), increased amylase (23%), and decreased leukocytes (23%).

The most common Grade 3 to 4 laboratory abnormalities (≥2%) in descending order were: decreased lymphocytes (11%), decreased albumin (9%), decreased sodium (8%), increased GGT (5%), increased amylase (4.6%), increased ALT (4.1%), increased AST (2.5%), and decreased hemoglobin (2%).

A clinically relevant laboratory abnormality in <20% of patients who received TEPMETKO was increased lipase in 18% of patients, including 3.7% Grades 3 to 4.

For more information about TEPMETKO, please see full Prescribing Information, and visit www.TEPMETKO.com.

Commitment to Cancer
EMD Serono is a science-led organization dedicated to delivering transformative medicines with the goal of making a meaningful difference in the lives of people affected by cancer. Our oncology research efforts aim to leverage our synergistic portfolio in oncogenic pathways, immuno-oncology, and DNA Damage Response (DDR) to tackle challenging tumor types in gastrointestinal, genitourinary, and thoracic cancers. Our curiosity drives our pursuit of treatments for even the most complex cancers, as we work to illuminate a path to scientific breakthroughs that transform patient outcomes. Learn more at www.emdseronooncology.com. Follow us on Twitter: @EMDOncologyUS and LinkedIn: EMD Serono, Inc.

References
1. Felip E, et al. WCLC 2021. Poster 170.
2. Ferlay J, et al. Eur J Cancer. 2018;103:356–387.
3. Reungwetwattana T, et al. Lung Cancer 2017;103:27-37.
4. Wolf J, et al. EORTC/NCI/AACR 2018. Poster 403.
5. Schrock AB, et al. J Thorac Oncol. 2016;11:1493–1502.
6. Tong JH, et al. Clin Cancer Res. 2016;22:3048–3056.8.

All Merck KGaA, Darmstadt, Germany, press releases are distributed by e-mail at the same time they become available on the EMD Group Website. In case you are a resident of the USA or Canada please go to www.emdgroup.com/subscribe to register again for your online subscription of this service as our newly introduced geo-targeting requires new links in the email. You may later change your selection or discontinue this service.

On December 17, 2021 Vincerx Pharma, Inc. (Nasdaq: VINC), a biopharmaceutical company aspiring to address the unmet medical needs of patients with cancer through paradigm-shifting therapeutics, reported that the first patient has been dosed in the Company’s Phase 1 dose-escalation study of VIP152 in relapsed or refractory (R/R) chronic lymphocytic leukemia (CLL) or Richter Syndrome (RS) (Press release, Vincerx Pharma, DEC 17, 2021, View Source [SID1234597377]).

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"The dosing of the first patient in Vincerx’s Phase 1 dose-escalation study of VIP152 in R/R CLL or RS marks the initiation of the second Vincerx-sponsored clinical trial this year, less than one year after becoming a publicly-listed company," said Ahmed Hamdy M.D., Chief Executive Officer of Vincerx. "Our data recently disclosed through an oral presentation at ASH (Free ASH Whitepaper) demonstrated increased selectivity and potency of VIP152 when compared with other CDK9 inhibitors currently in development, leading to cytotoxic activity in primary CLL samples as well as improved survival in a mouse model of CLL. With this compelling preclinical proof-of-concept data in hand, we are focused on advancing VIP152 across challenging indications like R/R CLL and RS, where targeted CDK9 inhibition has the potential to bring meaningful patient benefit. We are continuing our momentum in the clinic and remain on-track to initiate Phase 2 studies of VIP152 in the second half of 2022."

The Phase 1 study will evaluate VIP152 in patients with relapsed/refractory CLL who have failed a Bruton tyrosine kinase inhibitor (BTKi) and venetoclax and in patients with RS who have relapsed after, or been refractory to, at least one prior line of therapy for DLBCL and have MYC overexpression/amplification/translocation. A dose-escalation arm will be performed in R/R CLL before enrolling 20 additional patients in each of the CLL and RS cohorts.

The Phase 1 dose-escalation in CLL and RS builds upon Vincerx’s ongoing first-in-human (FIH) study (NCT04978779) in patients with advanced cancer, which consists of two expansion arms. Arm 1 will enroll up to 40 patients with relapsed/refractory aggressive lymphoma, including DLBCL, transformed follicular lymphoma, patients with mantle cell lymphoma who have failed a BTKi, as well as patients with any other type of lymphoma characterized by a MYC aberration. Arm 2 will enroll up to 40 patients with advanced solid tumors, including patients with ovarian cancer, triple negative breast cancer, castration-resistant neuroendocrine prostate cancer, and any other solid tumor with MYC aberration. All patients must have confirmed MYC overexpression or translocation.

On December 17, 2021 Sonnet BioTherapeutics Holdings, Inc. (NASDAQ:SONN) ("Sonnet" or the "Company"), a biopharmaceutical company developing innovative targeted biologic drugs, reported its financial results for the fiscal year ended September 30th, 2021 and provided a business update (Press release, Sonnet BioTherapeutics, DEC 17, 2021, View Source [SID1234597375]).

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Pankaj Mohan, Ph.D., Founder and CEO commented, "This year has been incredibly exciting for Sonnet. We identified a new bispecific candidate, SON-1410, and were granted patent-protection for our FHAB technology. Additionally, we generated compelling new data to progress our therapeutic pipeline, including successful preclinical studies for SON-1010 and SON-080, which set the stage for future clinical studies. We believe this positions us well for continued growth and advancement of our pipeline in 2022."

Fiscal Year 2021 and Recent Corporate Updates

Financings Completed: On August 24th, Sonnet successfully completed its follow-on offering of 35,294,117 shares of common stock and investor warrants for total net proceeds of approximately $27.6 million.

In June 2021, Sonnet completed the final issuance of shares of its common stock under the At-the-Market Sales Agreement, pursuant to which the Company executed issuances of an aggregate of 7,454,238 shares for total net proceeds of $15.2 million.

Issuance of U.S. Patent for Platform Technology: On June 8th, Sonnet announced the USTPO issued U.S. Patent No. 11,028,166 entitled, "Albumin Domain Fusion Proteins". The patent covers Sonnet’s Fully Human Albumin Binding (FHAB) technology and includes therapeutic fusion proteins that utilize FHAB for tumor targeting and retention and provide extended pharmacokinetics (PK). The patent carries a term effective until March 2039.

Completed Licensing Agreement with New Life Therapeutics: On May 3rd, Sonnet announced a definitive agreement with New Life Therapeutics of Singapore for the license of low-dose Interleukin 6, or IL-6, for the treatment of Diabetic Peripheral Neuropathy (DPN). The licensed territory includes the ASEAN countries of Singapore, Malaysia, Indonesia, Thailand, The Philippines, Cambodia, Brunei, Vietnam, Myanmar and Lao PDR.

Appointment of Richard Kenney and Manuel DaFonseca: On March 22nd, Sonnet announced the appointment of Richard Kenney, M.D. as Chief Medical Officer and Manuel DaFonseca, as Head of Clinical Operations.

Sonnet is pleased to provide the following updates on its pipeline assets:

SON-1010 (IL12-FHAB): On February 1st, Sonnet announced that it had successfully completed a non-human primate (NHP), non-GLP repeat-dose toxicology study of SON-1010. The drug candidate was well tolerated at doses far exceeding levels expected in future human clinical trials, without producing detectable cytokine imbalances. SON-1010 demonstrated an enhanced pharmacokinetic (PK) profile as compared to recombinant IL-12. Analysis of interferon-γ levels, a key biomarker of antitumor activity, continued to suggest potent pharmacodynamic (PD) effects in the monkeys studied.

On May 10th, Sonnet announced the completion of a successful GLP repeat dose toxicology study of SON-1010 in NHPs. The No Observed Adverse Event Level (NOAEL) following repeated administration was more than 50 times the anticipated equivalent human clinical dose in NHPs with no evidence of cytokine release syndrome. PK analysis of serum samples confirmed an enhanced profile of IL12-FHAB over recombinant human IL-12, with a half-life around 40 hours in NHPs. A significant increase in interferon-γ, a key pleiotropic cytokine associated with anti-tumor mechanisms, was observed following dosing with IL12-FHAB.

An IND for SON-1010 has been submitted to the FDA and additional product stability data will be submitted in the first quarter of 2022. Subject to FDA approval, we expect to initiate a US clinical trial in oncology patients with solid tumors during the first half of 2022. We are also preparing to initiate an Australian clinical trial in healthy volunteers during the first half of 2022 to study the compound’s PK and PD, in preparation for potential combination studies.

SON-080 (low-dose IL-6): On January 25th, Sonnet announced that Sonnet CH, a wholly owned subsidiary of Sonnet headquartered in Switzerland, had successfully completed a multiple dose NHP study of SON-080. The toxicology study demonstrated a wide safety margin with no adverse effects observed in male or female cynomolgus monkeys at the doses tested. Sonnet intends to file for an ex-US Phase 1b/2a pilot-scale efficacy study with SON-080 in CIPN during the first half of 2022. Pursuant to the license agreement the Company entered with New Life Therapeutics Pte., Ltd of Singapore in May 2021, Sonnet and New Life will be jointly responsible for developing SON-080 in DPN with the objective of initiating an ex-US pilot efficacy study in the second half of 2022.

SON-1210 (IL12-FHAB-IL15): SON-1210, Sonnet’s first bispecific candidate, is undergoing cell line and process development activities. Early development materials were used in a mouse tumor model study, and additional biodistribution studies are planned. This work will inform the Company’s decision about dosing in a forthcoming NHP study, expected to be initiated in the first half of 2022. Scale up and cGMP manufacturing is scheduled to be completed in the first half of 2022, which will support the GLP NHP study, as well as First-In-Human (FIH) studies. Sonnet expects to initiate the regulatory authorization process for solid tumor indications in the second half of 2022.

SON-1410 (IL18-FHAB-IL12): On August 30th, Sonnet announced that it had selected a novel development candidate after completing comparative studies in a mouse melanoma model. The candidate represents Sonnet’s second bispecific compound integrating interleukin 12 (IL-12) with the company’s FHAB platform. The target indications for SON-1410 will be melanoma and renal cancers.

Fiscal Year Ended September 30, 2021 Financial Results

Jay Cross, CFO, elaborated on Sonnet’s 2021 fiscal year results, saying, "The Company has made important forward progress with our balance sheet this fiscal year, and we expect to continue to deliver on our stated objectives of advancing our therapeutic pipeline. We believe we are in a good position to maintain our positive momentum through 2022."

●As of September 30, 2021, Sonnet had $27.6 million cash on hand, an increase from last quarter after a public offering in which the Company sold 33,193,485 shares of its common stock and pre-funded warrants to purchase 2,100,632 shares of common stock.
●The Company currently has outstanding 60,250,637 shares of common stock and warrants to purchase an aggregate of 51,789,522 shares of common stock, with a weighted average exercise price per share of $1.45. In the event all warrants were exercised for cash, the Company could receive up to $75.2 million of additional capital.

Research and development expenses were $16.6 million for the year ended September 30, 2021, compared to $9.9 million for the year ended September 30, 2020. The increase of $6.8 million was primarily due to the development of the cell lines for IL12-FHAB, IL12-FHAB-IL15 and SON-080, and an increase in payroll and share-based compensation expense, as we continue to expand our operations. General and administrative expenses were $8.9 million for the year ended September 30, 2021, compared to $7.5 million for the year ended September 30, 2020. The increase of $1.4 million was primarily due to an increase in payroll and share-based compensation expense and insurance expenses related to directors and officer’s insurance, as we continue to expand our operations to support our research and development efforts, partially offset by a $1.4 million decrease in professional fees and transaction related fees.