On February 13, 2025 GenomOncology, a precision medicine software company, and Pillar Biosciences, a leader in Decision Medicine, reported a co-marketing partnership aimed at advancing precision oncology care (Press release, GenomOncology, FEB 13, 2025, View Source [SID1234650268]). The collaboration will integrate GenomOncology’s cutting-edge clinical decision support platform with Pillar’s research-use-only (RUO) targeted Next Generation Sequencing (NGS) panels to enable healthcare providers with comprehensive workflows to advance personalized cancer insights.

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Early/Late Stage Pipeline Development - Target Scouting - Clinical Biomarkers - Indication Selection & Expansion - BD&L Contacts - Conference Reports - Combinatorial Drug Settings - Companion Diagnostics - Drug Repositioning - First-in-class Analysis - Competitive Analysis - Deals & Licensing

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This collaboration aims to provide personalized and effective cancer treatment guidance by integrating genomic data through GenomOncology’s Pathology Workbench reporting, enabling a seamless workflow from the NGS sequencer to the report. Together, the companies will leverage genomic data, enabling healthcare providers to advance informed decisions based on the unique genomic profiles of individual patients. By combining their expertise, GenomOncology and Pillar Biosciences are committed to optimizing and accelerating the use of genomic data to support precision medicine in oncology, while streamlining the implementation of their respective and now integrated solutions.

"Partnering with Pillar Biosciences will allow us to enhance our offering and provide clinicians with an integrated, data-driven sample to answer approach to precision cancer management," said Garreth Hippe, Chief Commercial Officer of GenomOncology. "This collaboration enables us to provide more comprehensive, actionable insights for cancer care, empowering healthcare providers to make better, more informed decisions."

"We are excited to collaborate with GenomOncology to further expand our portfolio and provide complete solutions to researchers and treating clinicians," said Dan Harma, Chief Commercial Officer of Pillar Biosciences. "By combining our next-generation sequencing capabilities with their decision support platform, we can help deliver more rapid personalized cancer data that may help improve oncology patient management."

On February 13, 2025 Aptose Biosciences Inc. ("Aptose" or the "Company") (NASDAQ: APTO, TSX: APS), a clinical-stage precision oncology company developing the tuspetinib (TUS)-based triple drug frontline therapy to treat patients with newly diagnosed AML, reported it has entered into a common share purchase agreement and registration rights agreement with an institutional investor (Press release, Aptose Biosciences, FEB 13, 2025, View Source [SID1234650266]).

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Early/Late Stage Pipeline Development - Target Scouting - Clinical Biomarkers - Indication Selection & Expansion - BD&L Contacts - Conference Reports - Combinatorial Drug Settings - Companion Diagnostics - Drug Repositioning - First-in-class Analysis - Competitive Analysis - Deals & Licensing

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The Committed Equity Facility agreement provides Aptose the right, in its sole option and discretion without obligation, to sell and issue up to $25 million of its common shares (the "Common Shares") over the course of 24 months to the Investor, subject to certain conditions being met, and subject to certain limitations and conditions imposed by the Nasdaq Capital Market ("Nasdaq"), the U.S. Securities and Exchange Commission (the "SEC") and other regulators. The securities offered have not been registered under the Securities Act of 1933 and may not be offered or sold in the United States absent registration or an applicable exemption from registration requirements. No Common Shares will be sold on the Toronto Stock Exchange ("TSX") or other trading market in Canada under the common share purchase agreement. The TSX has conditionally approved the committed equity facility based on the exemption set forth in Section 602.1 of the TSX Company Manual.

Aptose also announced it has entered into a sales agreement to issue and sell Common Shares through "at-the-market" (ATM) distributions on the Nasdaq. Aptose will decide the timing, price, and number of shares sold. Prospectus supplements (the "Prospectus Supplements") have been filed with the SEC qualifying the offer and sale of Common Shares (i) to the Investor with an aggregate offering price of up to US $25 million and (ii) pursuant to the sales agreement with an aggregate offering price of up to US $1 million. The Prospectus Supplements and accompanying prospectus are available on EDGAR at www.sec.gov and can also be accessed on the SEC’s website at View Source Investors should review the Prospectus Supplements and other filed documents for comprehensive information about the issuer and the offering before making any investments.

This press release does not constitute an offer to sell or the solicitation of offers to buy any securities of Aptose, and shall not constitute an offer, solicitation, or sale of any security in any state or jurisdiction in which such offer, solicitation or sale would be unlawful prior to registration or qualification under the securities laws of any such state or jurisdiction.

On February 13, 2025 Oncotelic Therapeutics, Inc (OTCQB:OTLC). Oncotelic Therapeutics, a leader in RNA-based therapeutics, reported that Vuong Trieu, Ph.D., Chairman & CEO, will be delivering a featured presentation at the SWCR 2025 Conference on March 24th (Press release, Oncotelic, FEB 13, 2025, View Source [SID1234650261]). His talk will highlight the central role of Transforming Growth Factor Beta 2 (TGFB2) in the convergence of disease pathways spanning cancer, lupus, and aging, as well as its potential as a therapeutic target in immuno-oncology.

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Dr. Trieu’s presentation, titled "Transforming Growth Factor Beta 2 in Aging, Cancer, Lupus, and Immuno-Oncology: A Convergence of Disease Pathways and Therapeutic Potential," will delve into the immunosuppressive mechanisms of TGFB2 and its profound impact on solid tumors, autoimmune disorders, and age-related diseases. His research underscores how high TGFB2 expression fosters tumor-associated macrophage infiltration, disrupts antigen presentation, and drives resistance to immunotherapy-ultimately contributing to poor patient outcomes.

A key focus of the presentation will be the clinical development of OT-101, an antisense therapeutic targeting TGFB2, which is currently in Phase 3 clinical trials (STOP-PC study) for pancreatic ductal adenocarcinoma (PDAC). The talk will explore how TGFB2 inhibition-alone or in combination with immune checkpoint inhibitors or interferon-based strategies-may reshape the tumor microenvironment, boost immune response, and enhance therapeutic efficacy.

Dr. Vuong Trieu’s Vision for TGFB2 as a Therapeutic Target

"TGFB2 has emerged as a master regulator of immune suppression, not just in cancer but across multiple chronic diseases," said Dr. Trieu. "Our work on OT-101 aims to neutralize TGFB2-driven resistance, unlocking the full potential of immunotherapy and improving outcomes for patients with pancreatic cancer, gliomas, and beyond."

On February 13, 2025 Ultragenyx Pharmaceutical Inc. (NASDAQ: RARE), a biopharmaceutical company focused on the development and commercialization of novel therapies for serious rare and ultrarare genetic diseases, reported its financial results for the quarter and full year ended December 31, 2024 and shared financial guidance for 2025 (Press release, Ultragenyx Pharmaceutical, FEB 13, 2025, View Source [SID1234650260]).

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Early/Late Stage Pipeline Development - Target Scouting - Clinical Biomarkers - Indication Selection & Expansion - BD&L Contacts - Conference Reports - Combinatorial Drug Settings - Companion Diagnostics - Drug Repositioning - First-in-class Analysis - Competitive Analysis - Deals & Licensing

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"We have created a next-generation rare disease company on a pathway to profitability with meaningful revenue growth from multiple global products and a series of potential new drug approvals," said Emil D. Kakkis, M.D., Ph.D., chief executive officer and president of Ultragenyx. "The major regulatory and clinical catalysts ahead of us this year are the pending PDUFA decision for our gene therapy to treat Sanfilippo syndrome, submission of our second gene therapy biologics license application in Glycogen Storage Disease Type Ia, readout of our pivotal Phase 3 results in osteogenesis imperfecta, and completion of enrollment in our Phase 3 trial in Angelman syndrome."

Fourth Quarter and Full Year 2024 Selected Financial Data Tables and Financial Results

Revenues (dollars in thousands), (unaudited)
Three Months Ended December 31, Year Ended December 31,
2024 2023 2024 2023
Crysvita
Product sales $ 22,415 $ 18,379 $ 134,709 $ 75,697
Revenue in Profit-Share Territory 85,534 70,124 248,966 231,574
Royalty revenue in European Territory 7,473 5,612 25,849 20,783
Total Crysvita Revenue 115,422 94,115 409,524 328,054
Dojolvi 31,103 23,286 88,194 70,633
Evkeeza 10,374 2,102 32,162 3,642
Mepsevii 7,978 7,889 30,350 30,441
Other — — — 1,479
Total revenues $ 164,877 $ 127,392 $ 560,230 $ 434,249

Total Revenues
Ultragenyx reported $165 million in total revenue for the fourth quarter of 2024, which represents 29% growth compared to the same period in 2023. Fourth quarter 2024 Crysvita revenue was $115 million, which represents 23% growth compared to the same period in 2023. This includes product sales of $22 million from Latin America and Turkey, which represents 22% growth compared to the same period in 2023. Dojolvi revenue in the fourth quarter 2024 was $31 million, which represents 34% growth compared to the same period in 2023. Evkeeza revenue in the fourth quarter 2024 was $10 million.

Total revenue for the year ended December 31, 2024 was $560 million, which represents 29% growth compared to the prior year. Full year 2024 Crysvita revenue was $410 million, which represents 25% growth compared to the prior year. This includes product sales of $135 million from Latin America and Turkey, which represents 78% growth compared to the prior year. Dojolvi revenue in 2024 was $88 million, which represents 25% growth compared to the prior year. Evkeeza revenue in 2024 was $32 million, as demand continues to build following launches in the company’s territories outside of the United States.

Selected Financial Data (dollars in thousands, except per share amounts), (unaudited)
Three Months Ended December 31, Year Ended December 31,
2024 2023 2024 2023
Total revenues $ 164,877 $ 127,392 $ 560,230 $ 434,249
Operating expenses:
Cost of sales 16,894 12,051 76,728 45,209
Research and development 187,766 160,557 697,865 648,449
Selling, general and administrative 82,495 76,833 321,610 309,799
Total operating expenses 287,155 249,441 1,096,203 1,003,457
Net loss $ (133,385 ) $ (123,190 ) $ (569,183 ) $ (606,639 )
Net loss per share, basic and diluted $ (1.39 ) $ (1.52 ) $ (6.29 ) $ (8.25 )

Operating Expenses
Total operating expenses for the fourth quarter of 2024 were $287 million, including non-cash stock-based compensation of $40 million. Total operating expenses for the year ended December 31, 2024 were $1,096 million, including $158 million of non-cash stock-based compensation.

Net Loss
For the fourth quarter of 2024, Ultragenyx reported net loss of $133 million, or $1.39 per share basic and diluted, compared with a net loss for the fourth quarter of 2023 of $123 million, or $1.52 per share basic and diluted. For the year ended December 31, 2024, Ultragenyx reported net loss of $569 million, or $6.29 per share basic and diluted, compared with a net loss the prior year of $607 million, or $8.25 per share, basic and diluted.

Cash Balance and Net Cash Used in Operations
Cash, cash equivalents, and marketable debt securities were $745 million as of December 31, 2024. Net cash used in operations for the year ended December 31, 2024 was $414 million.

2025 Financial Guidance
Revenues are expected to grow approximately 14-20% compared to 2024. The company will continue to prioritize expense management, focusing its investments on the execution of multiple upcoming commercial launches and advancing multiple Phase 3 programs. Together, this is expected to lead to a reduction in 2025 net cash used in operations compared to 2024.

For the full year 2025:

Total revenue to be in the range of $640 million to $670 million
Crysvita revenue to be in the range of $460 million to $480 million
Dojolvi revenue to be in the range of $90 million to $100 million
Recent Updates and Clinical Milestones

UX143 (setrusumab) monoclonal antibody for osteogenesis imperfecta (OI): Phase 3 Orbit study progressing to second interim analysis (IA2) expected in mid-2025

Patients continue dosing in the ongoing Phase 3 Orbit and Cosmic clinical trials, which evaluate setrusumab in pediatric and young adult patients with OI. The randomized, placebo-controlled Phase 3 portion of the Orbit study is progressing towards the second interim analysis in mid-2025 or a final analysis in the fourth quarter 2025. Conduct of the study is going well and patient safety in the Phase 3 is consistent with the Phase 2. Patients in the Cosmic study also are continuing to be treated with either setrusumab or intravenous bisphosphonates (IV-BP) therapy and will be evaluated in parallel with the Orbit interim and final analyses.

GTX-102 an antisense oligonucleotide for Angelman syndrome: Phase 3 study enrolling; expect enrollment completion in second half of 2025

Enrollment in the global Phase 3 Aspire study began in December 2024 and is expected to enroll approximately 120 children ages four to 17 with Angelman syndrome with a genetically confirmed diagnosis of full maternal UBE3A gene deletion. Participants will be randomized 1:1 to receive GTX-102 by intrathecal injection via lumbar puncture or to the sham comparator group during the 48-week primary efficacy analysis period. The primary endpoint will be improvement in cognition assessed by Bayley-4 cognitive raw score, and the key secondary endpoint (with a 10% allocation of alpha) will be the Multi-domain Responder Index (MDRI) across the five domains of cognition, receptive communication, behavior, gross motor function, and sleep. Enrollment in the Phase 3 Aspire study is expected to complete in the second half of 2025.

The Phase 2/3 Aurora study, which will evaluate GTX-102 in other Angelman syndrome genotypes and ages, is expected to initiate in 2025.

UX111 AAV gene therapy for Sanfilippo syndrome type A (MPS IIIA): Biologics license application (BLA) submitted; expect Prescription Drug User Fee Act (PDUFA) decision on the application and potential launch in second half of 2025

In December 2024, Ultragenyx submitted a BLA to the U.S. Food and Drug Administration for UX111 supported by the available data, including from the ongoing pivotal Transpher A study. New clinical data were recently presented at WORLDSymposium 2025, that demonstrated treatment with UX111 led to a statistically significant improvement in the Bayley-III raw scores for the subdomains of cognition, receptive communication and expressive communication in patients with MPS IIIA compared to natural history data from untreated patients. These clinical endpoints were correlated with substantial and sustained reduction in levels of heparan sulfate in cerebrospinal fluid. A PDUFA decision and potential launch are expected in the second half of 2025.

DTX401 AAV gene therapy for Glycogen Storage Disease Type Ia (GSDIa): BLA filing expected in mid-2025

Ultragenyx previously announced positive topline results from the Phase 3 GlucoGene study for the treatment of patients aged eight years and older. The study achieved its primary endpoint, demonstrating that treatment with DTX401 resulted in a statistically significant and clinically meaningful reduction in daily cornstarch intake compared with placebo at Week 48.

After the 48-week primary efficacy analysis period, crossover patients (previously treated with placebo) were eligible to receive DTX401. These patients were able to titrate cornstarch much more rapidly once they were confirmed to have been treated and had timely direct access to their glucose levels. Patients from the original DTX401 treatment arm who have reached 78 weeks also continued to reduce their daily cornstarch intake, while maintaining glycemic control. DTX401 has demonstrated a consistent and acceptable safety profile with no new safety concerns identified as of the data cut-off.

These results have been discussed with regulatory authorities in a pre-BLA meeting and will be included as part of a BLA submission in mid-2025.

DTX301 AAV gene therapy for Ornithine Transcarbamylase (OTC) Deficiency: Enrollment in Phase 3 study complete

Enrollment in the Phase 3 Enh3ance study has been completed with a total of 37 patients. The pivotal study enrolled participants 12 years of age and older, randomized 1:1 to DTX301 or placebo. The primary endpoints are response as measured by change in 24-hour ammonia levels and removal of ammonia-scavenger medications and protein-restricted diet. Based on the recently amended protocol, the change in 24-hour ammonia levels will be measured through Week 36 after which the study would unblind and patients will be followed for a total of up to 64 weeks to determine the complete responders able to remove safely both ammonia-scavenger medications and protein-restricted diet control.

UX701 AAV gene therapy for Wilson Disease: Phase 1/2/3 study ongoing; expect Cohort 4 enrollment completion in second half of 2025

In Stage 1 of the Phase 1/2/3 Cyprus2+ study, 15 patients across three sequential dose cohorts were enrolled and demonstrated clinical activity as well as improvements in copper metabolism. Multiple responders completely tapered off their standard-of-care treatment with responses seen in all three dose cohorts.

The company expects to enroll a fourth cohort in Stage 1 at a moderately increased dose and with an optimized immunomodulation regimen to enhance the efficiency and efficacy of the gene therapy, with the objective of having the majority of patients come off standard-of-care treatment before selecting a dose for the randomized placebo-controlled stage of the study. Enrollment in Cohort 4 is expected to complete in the second half of 2025.

Conference Call and Webcast Information

Ultragenyx will host a conference call today, Thursday, February 13, 2025, at 2 p.m. PT/5 p.m. ET to discuss the fourth quarter and full year 2024 financial results and provide a corporate update. The live and replayed webcast of the call will be available through the company’s website at View Source The replay of the call will be available for three months.

On February 13, 2025 Sonnet BioTherapeutics Holdings, Inc. (the "Company" or "Sonnet") (NASDAQ: SONN), a clinical-stage company developing targeted immunotherapeutic drugs, reported its financial results for the three months ended December 31, 2024 and provided a business update (Press release, Sonnet BioTherapeutics, FEB 13, 2025, View Source [SID1234650259]).

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"We have made strides in our Phase 1 SB101 trial with established clinical benefit including a 45% reduction in tumor size by RECIST criteria indicating a partial response and demonstrating the effectiveness of our FHAB platform. This encouraging data with SON-1010 excites us with the ongoing combination trials with Atezolizumab and with the initiation of recruitment for the combination with trabectedin (Yondelis). Additionally, we continue to bolster our global patent estate and differentiate our plug and play strategy from any competitive technologies that may leverage the beneficial characteristics of binding to human serum albumin," commented Pankaj Mohan, Ph.D., Founder and CEO of Sonnet. "As we look to the remainder of the calendar year, our focus is on our clinical programs and building on our momentum toward meeting potentially catalytic milestones including a number of key clinical data readouts; all of which we believe have the potential to build shareholder value."

Recent Highlights

● Entered into a licensing agreement with Alkem Laboratories Limited ("Alkem") to develop and commercialize SON-080 in India (October 2024).

● Completion of SON-1010 (IL12-FHAB) Monotherapy Dose Escalation in Phase 1 SB101 trial and announced topline safety data (December 2024).

● Closed a registered direct offering and concurrent private placement priced at-the-market under Nasdaq rules for aggregate gross proceeds of $3.9 million (December 2024).

● Announced granting of EU Patent No. EP3583125 B1 covering its FHAB platform technology (January 2025).

● Expanded its Phase 1 SB101 clinical study of SON-1010 (IL12-FHAB) in adult patients with advanced solid tumors by adding a new patient cohort to evaluate the effect of SON-1010 in combination with trabectedin (January 2025).

Lead Clinical Programs Update

SON-1010: Targeted Immune Activation Cancer Therapy, Turning ‘Cold’ Tumors ‘Hot’, Initially Targeting Solid Tumors and Platinum-Resistant Ovarian Cancer (PROC)

Phase 1 Trial (SB101 Trial): Advanced Solid Tumors (Monotherapy)

The Company announced the topline safety data from the SB101 trial and completion of dose escalation in December 2024, establishing the MTD as 1200 ng/kg. The final 1200 ng/kg dose-escalation cohort was increased in size to 6 patients to enhance the assessment of PK and PD at the MTD. The SB101 trial employed a ‘desensitizing’ first dose of 300 ng/kg to take advantage of the known tachyphylaxis with rhIL-12, with the intention of minimizing toxicity and allowing for higher maintenance doses.

Of the 24 patients dosed to date, 17 (71%) had stable disease at the first follow-up CT, 12 of whom were progressing at study entry. 10 of the 21 evaluable patients (48%) remained stable at four months, suggesting SON-1010 clinical benefit, and one of those patients in the highest dose cohort, who has clear cell sarcoma, had a PR with a 45% reduction in tumor size by RESIST criteria. As previously disclosed, one patient in the first dose cohort with endometrial sarcoma who was progressing at study entry had evidence of improvement after 11 months, with smaller tumors and complete resolution of ascites. This patient later progressed at 23 months and started chemotherapy. No dose-limiting toxicities or related serious adverse events (SAE) have occurred to date. The safety and toxicity profile that has developed is typical for a Phase 1 oncology trial, with the majority of adverse events (AEs) being reported as mild. All AEs seen to date have been transient, with no evidence of cytokine release syndrome.

The Company recently announced expansion of its Phase 1 SB101 clinical study of SON-1010 (IL12-FHAB) in adult patients with advanced solid tumors to add a new cohort to evaluate the effect of SON-1010 in combination with trabectedin in certain advanced soft-tissue sarcomas (STS), following the successful completion of monotherapy dose escalation. Enrollment in this cohort is underway and is expected to be completed in H1 calendar year 2025. Topline safety data of the combination with trabectedin is expected in H2 calendar year 2025. No new safety concerns have been reported to date.

For more information about the SB101 clinical trial, visit clinicaltrials.gov and reference identifier NCT05352750.

Phase 1b/2a Trial (SB221 Trial): Advanced Solid Tumors and PROC (Combo with Atezolizumab)

The second trial is a global Phase 1b/2a multicenter, dose-escalation and randomized proof-of-concept study to assess the safety, tolerability, PK, PD, and efficacy of SON-1010 administered subcutaneously (SC) in combination with atezolizumab given intravenously (IV) (in collaboration with Genentech, a member of the Roche Group). Enrollment remains ongoing and an update on safety in that trial is expected in Q1 calendar year 2025.

For more information about the SB221 clinical trial, visit clinicaltrials.gov and reference identifier NCT05756907.

SON-1010 Upcoming Milestones

● Phase 1: Solid Tumors (Monotherapy)

○ H1 Calendar Year 2025: Topline Efficacy Data

● Phase 1b/2a: PROC (Combo with Atezolizumab)

○ Q1 Calendar Year 2025: Additional Safety Data
○ H2 Calendar Year 2025: RP2D & Topline Efficacy Data

● Phase 1: STS (Combo with Trabectedin)

○ H2 Calendar Year 2025: Topline Safety Data

SON-1210: Proprietary, Bifunctional Version of Human Interleukins 12 (IL-12) and 15 (IL-15), Configured Using Sonnet’s Fully Human Albumin Binding (FHAB) platform, in Combination with Chemotherapy for the Treatment of Advanced Solid Tumors and Metastatic Pancreatic Cancer

In August 2024, the Company entered into a Master Clinical Collaboration Agreement with the Sarcoma Oncology Center to conduct an investigator-initiated Phase 1/2a clinical study to evaluate SON-1210 in combination with several chemotherapeutic agents including but not limited to NALIRIFOX (the combination of liposomal irinotecan, 5-fluorouracil/leucovorin, and oxaliplatin) for the specific treatment of metastatic pancreatic cancer. The NALIRIFOX regimen is U.S. FDA-approved for the treatment of metastatic pancreatic cancer in the front-line and refractory settings. The Company expects to submit the IND for SON-1210 in Q1 calendar year 2025.

SON-1210 Upcoming Milestones

● Q1 Calendar Year 2025: IND Submission
● H1 Calendar Year 2025: 1st Patient Dosed in Investigator-Initiated Phase 1/2a Study

SON-080: Low dose of rhIL-6 for Chemotherapy-Induced Peripheral Neuropathy (CIPN) and Diabetic Peripheral Neuropathy (DPN)

In October 2024, the Company entered into a licensing agreement with Alkem for the research, development, manufacturing, marketing, and commercialization of its SON-080 molecule for the treatment of DPN in India and the manufacturing, marketing, and commercialization of SON-080 for CIPN and autonomic neuropathy in India. Alkem will conduct all clinical trials it believes appropriate to obtain regulatory approval of SON-080 in India for the treatment of DPN. Subsequent to the partnership established with Alkem, preparations are being made to support initiation of a Phase 2 clinical trial in DPN, a mechanistically synergistic and larger, high-value indication with unmet medical need.

SON-080 Upcoming Milestone

● H2 Calendar Year 2025: Initiation of Phase 2 Trial

Summary of Financial Results for First Quarter Fiscal Year 2025

For the fiscal first quarter ended December 31, 2024, Sonnet reported a net loss of $3.2 million, or $1.56 per basic and diluted share, compared to a net loss of $1.2 million, or $2.46 per basic and diluted share, for the for the fiscal quarter ended December 31, 2023.

As of December 31, 2024, Sonnet had cash and cash equivalents of $4.9 million.

Company Leadership Reorganization – The Company has promoted Dr. Stephen McAndrew from his role as Senior Vice President, Business Development, to Chief Business Officer to enhance its focus on business development, effective February 17, 2025. Mr. Jay Cross submitted his resignation as Chief Financial Officer, effective February 21, 2025. Mr. Cross will be succeeded by Mr. Donald Griffith, CPA, who has been promoted as the new Chief Financial Officer from his role as Controller, effective February 21, 2025. This update to the Company’s leadership team will preserve a continued focus on advancing business development opportunities while remaining vigilant on cost controls.