On May 15, 2024 Rezolute, Inc., a clinical-stage biopharmaceutical company committed to developing novel, transformative therapies for serious metabolic and rare diseases, reported financial results and provided a business update for the three months ended March 31, 2024 (Press release, Rezolute, MAY 15, 2024, View Source [SID1234643338]).

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"In the past few months, we have been focused on global site activation and patient enrollment for sunRIZE, a pivotal Phase 3 clinical study of RZ358 in patients with congenital hyperinsulinism. We have also completed dosing of patients with diabetic macular edema for our Phase 2 multi-center clinical study of RZ402 and we expect to announce topline results from that study this month," said Nevan Elam, Chief Executive Officer and Founder of Rezolute. "Additionally, in the U.S. we continue to have productive interactions with FDA as we work towards achieving liberalization of the partial clinical holds on sunRIZE."

Recent Pipeline Progress and Anticipated Milestones

Congenital Hyperinsulinism (cHI)

Patient enrollment underway in sunRIZE, a global, pivotal Phase 3 clinical study of RZ358 in patients with cHI in Europe and other geographies outside of the U.S.
Enrollment is expected to complete by the end of 2024.
Topline results expected in mid-2025.

As part of the effort to resolve the partial clinical holds in the U.S., the Company conducted and recently completed an in-vivo toxicology study in brown Norway rats using Sprague Dawley (SD) rats as a positive control.
Early results show that at the highest tested dose of 40 mg/kg, there were no observed liver abnormalities in the brown Norway rat, which is approximately four times higher than the dose that results in microvascular liver abnormalities in SD rats. Additionally, at the 40 mg/kg dose in this study, SD rats had liver abnormalities consistent with previous in-vivo studies.
The Company believes that the Norway rat study adds to the body of evidence that the rat findings are specific to the SD rat and are not otherwise relevant, based on the absence of findings in other rat strains, other rodent species (CD-1 mice), primates, and humans in studies to date.
Final data tabulations and a report for this study will be completed in the coming weeks. The company plans to submit this study as well as additional in-vitro information to the FDA this summer as part of a complete response to the partial clinical holds.
Tumor Hyperinsulinism (HI)

Alignment with FDA to conduct a potential late-stage, registrational, clinical study in both non-islet cell tumor hypoglycemia (NICTH) and insulinoma patients, which would be the second development program and rare disease indication for RZ358.
To date, five metastatic insulinoma patients have been treated with RZ358 in the Expanded Access Program (EAP).
Potential initiation of a development program for this indication is currently under evaluation by the Company. Updates will be provided later this year.

Diabetic Macular Edema (DME)

Completed patient dosing for Phase 2 U.S., multi-center clinical study in 94 participants with DME who are naïve to or have received limited anti-VEGF injections.
Primary endpoints include (i) stabilization of disease and/or change in study eye macular central subfield thickness, as measured by Spectral Domain Ocular Coherence Tomography, (ii) change in study eye visual acuity as measured by the early treatment diabetic retinopathy scale, (iii) the repeat dose pharmacokinetics of RZ402 in patients with DME, and (iv) the safety and tolerability of RZ402.
Topline results expected in May 2024.

Fiscal Third Quarter Financial Results

Cash, cash equivalents and investments in marketable securities were $81.6 million as of March 31, 2024, compared with $118.4 million as of June 30, 2023.

Research and development expenses were $12.4 million for the third quarter of fiscal 2024, compared with $14.2 million for the same period a year ago, with the decrease primarily attributable to a reduction in milestone expense of $3.0 million due to Phase 2 dosing milestone triggered in RZ402, with no comparative expense incurred in the current year, offset partially by an increase of R&D personnel-related expenses due to increased headcount.

General and administrative expenses were $3.8 million for the third quarter of fiscal 2024, compared with $2.9 million for the same period a year ago, with the increase primarily attributable to personnel-related expenses due to increased headcount.

Net loss was $17.1 million for the third quarter of fiscal 2024 compared with a net loss of $15.7 million for the same period a year ago.

On May 15, 2024 PDS Biotechnology Corporation, a late-stage immunotherapy company focused on transforming how the immune system targets and kills cancers and the development of infectious disease vaccines, reported a business update and reported financial results for the first quarter of 2024. The press release will be available in the Investor Relations section of the Company’s website at www.pdsbiotech.com (Press release, PDS Biotechnology, MAY 15, 2024, View Source [SID1234643337]).

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Recent Developments

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Hosted a Key Opinion Leader event on May 8, 2024 during which prominent experts in head and neck squamous cell cancer ("HNSCC") discussed positive, updated VERSATILE-002 data and the unmet need in HPV16-positive HNSCC. A replay of the event can be found here.

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Announced updated results from the VERSATILE-002 Phase 2 trial evaluating first line treatment of patients with HPV16-positive recurrent or metastatic HNSCC using Versamune HPV + KEYTRUDA (pembrolizumab) (n=53).

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Median overall survival is 30 months; Published results for immune checkpoint inhibitors are 7-18 months.

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The cohort met its primary endpoint of best overall response (BOR).

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BOR by investigator assessment is 34% (Combined Positive Score (CPS) ≥1; n=18/53); 48% (CPS≥20; n=10/21); Published results for ICIs are <20% (CPS>1) and <25% (CPS≥20).

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CPS is used to assess PD-L1 expression

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Progression free survival is 6.3 months (CPS≥1); 14.1 months (CPS≥20); Published results for immune checkpoint inhibitors 2-3 months.

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VERSATILE-002 data to date indicate a durable response in first line recurrent or metastatic HNSCC patients with CPS≥1.

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The combination of Versamune HPV + pembrolizumab was well tolerated.

Announced an updated clinical strategy with a two-part registrational trial focused on the triple combination of Versamune HPV + PDS01ADC + pembrolizumab as a first line treatment in HPV16-positive recurrent or metastatic HNSCC.

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PDS01ADC is the Company’s novel, investigational tumor-targeting IL-12-fused antibody-drug conjugate (ADC), which has shown promise in a clinical trial of Versamune HPV + PDS01ADC + an investigational ICI conducted by the National Cancer Institute.

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Part one of the clinical trial will focus on dose optimization with a data readout based on safety and objective response rate.

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The randomized second part of the trial will include an interim data readout with overall survival as its primary endpoint.

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Further strengthened management with the addition of Stephan Toutain, M.S., MBA, as Chief Operating Officer. Mr. Toutain brings extensive operational and commercial experience to PDS Biotech.

Versamune Platform Intellectual Property

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Company received patents granted by the Israel Patent Office and IP Australia that will extend protections for the Company’s novel investigational T cell activating Versamune platform through Dec. 2038 and Nov. 2036, respectively.

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The Israel Patent Office granted patent No. 275154 titled, "Methods and compositions comprising cationic lipids for stimulating type I interferon genes," extending protections for compositions using the Versamune platform and comprising of cationic lipid for activating type I interferons. This patent covers all formulations and compositions that include Versamune to activate a T cell response.

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IP Australia granted patent No. 2016354590 titled, "Lipids as synthetic vectors to enhance antigen processing and presentation ex-vivo in dendritic cell therapy." This patent covers the use of Versamune compositions that reduce the populations of immune suppressive cells in the tumor and its application for the development of dendritic cell-based approaches to immunotherapy.

First Quarter 2024 Financial Results
Reported net loss was approximately $10.6 million, or $0.30 per basic share and diluted share, for the three months ended March 31, 2024, compared to a net loss of $9.7 million, or $0.32 per basic share and diluted share, for the three months ended March 31, 2023. The increase was due to higher operating and net interest expenses.

Research and development expenses increased to approximately $6.7 million for the three months ended March 31, 2024, from $5.8 million for the three months ended March 31, 2023. The increase of $0.9 million was primarily attributable to an increase of $1.2 million in clinical studies and medical affairs offset by a decrease of $0.1 million in personnel costs, $0.1 million in professional fees and $0.1 million in manufacturing expenses.

General and administrative expenses decreased to approximately $3.4 million for the three months ended March 31, 2024, from approximately $3.6 million for the three months ended March 31, 2023. The decrease of $0.2 million was primarily attributable to an increase of $0.3 million in professional fees offset by a decrease of $0.5 million in personnel costs.

Total operating expenses increased to approximately $10.1 million for the three months ended March 31, 2024 from $9.4 million for the three months ended March 31, 2023.

Net interest expenses increased to approximately $0.5 million for the three months ended March 31, 2024 from $0.2 million for the three months ended March 31, 2023.

Cash and cash equivalents as of March 31, 2024, totaled approximately $66.6 million.

On May 15, 2024 Panbela Therapeutics, Inc., a clinical stage company developing disruptive therapeutics for the treatment of patients with urgent unmet medical needs, reported a business update and reports financial results for the quarter ended March 31, 2024 (Press release, Panbela Therapeutics, MAY 15, 2024, View Source [SID1234643336]). As previously announced, management is hosting earnings call today at 4:30 p.m. ET.

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Q1 2024 and recent Highlights:
Clinical
Announced revised timing for the interim data analysis for its ongoing ASPIRE trial, evaluating ivospemin (SBP-101) in combination with standard-of-care for metastatic pancreatic ductal adenocarcinoma (mPDAC). The analysis is now expected in Q1 2025 due to a lower-than-anticipated event rate, which suggests high potential for improved survival outcomes for patients in the trial.

Poster presentation of Ivospemin (SBP-101) at AACR (Free AACR Whitepaper) highlighting the efficacy of SBP-101 in combination with doxorubicin to treat platinum-resistant ovarian cancer

ASPIRE trial has exceeded 50% enrollment; complete enrollment of approximately 600 patients anticipated by Q1 2025

Publication of Clinical Data: Phase 1 study of high-dose DFMO, celecoxib, cyclophosphamide and topotecan for patients with relapsed neuroblastoma: a New Approaches to Neuroblastoma Therapy trial. Br J Cancer 130, 788–797 (2024)

Financial / Business
• Gained eligibility for quotation of common stock on the OTCQB
• Closed $9.0 million public offering of common stock and warrants
• Issuance of a New Patent in the US and Canada for Claims of a Fixed Dose Combination of Eflornithine and Sulindac

"We were thrilled to announce that our ongoing ASPIRE trial, evaluating ivospemin (SBP-101) in combination with standard-of-care for metastatic pancreatic ductal adenocarcinoma, or mPDAC, is now expected to reach its interim data analysis in the first quarter of 2025, due to a lower-than-anticipated event rate, suggesting improved survival outcomes for patients in the trial. This gives us hope for meaningful advancements in mPDAC treatment beyond the incremental benefits seen with recently approved therapies," said Jennifer K. Simpson, PhD, MSN, CRNP, President & CEO of Panbela.

"In addition to the progress in our ASPIRE trial, which has now exceeded 50% enrollment with complete enrollment of approximately 600 patients anticipated by Q1 2025, we were pleased to present a poster highlighting the efficacy of SBP-101 in combination with doxorubicin for treating platinum-resistant ovarian cancer at AACR (Free AACR Whitepaper). We also welcomed the publication of clinical data from our Phase I study of high-dose DFMO, celecoxib, cyclophosphamide, and topotecan for patients with relapsed neuroblastoma in the British Journal of Cancer. On the financial and business front, we announced the transfer of our common stock to the OTCQB market and successfully closed a $9.0 million public offering. As we look ahead, Panbela remains steadfast in its commitment to improving patient outcomes and driving value for our stockholders, with several key catalysts on the horizon, including the highly anticipated overall survival interim analysis in our Phase III ASPIRE Trial."

First Quarter ended March 31, 2024 Financial Results
General and administrative expenses were approximately $1.2 million in the quarter, compared to $1.4 million in the same period last year. The decrease is due primarily to reduced legal and other professional services.

Research and development expenses were approximately $5.5 million, compared to $3.5 million in the same period last year. This increase is primarily due to significant growth in the number of active sites and enrollment in project ASPIRE.

Net loss in the quarter was approximately $7.1 million, or $2.28 per diluted share, compared to a net loss of $5.1 million, or $392.76 per diluted share, in the same period last year. This increased loss is due to the incremental research and development expenses.

Total cash was $262,000 as of March 31, 2024. Total current assets were $1.8 million and current liabilities were $10.5 million as of the same date. In April the Company’s partner in Pediatric Neuroblastoma, US WorldMeds, provided a nondilutive payment of approximately $0.8 million in exchange for a reduction in the potential future milestone payments.

Notes payable, plus accrued interest, on the balance sheet, the result of the acquisition of CPP, totaled approximately $4.2 million. The current portion of the notes payable plus accrued interest totaled approximately $1.3 million and was paid to the noteholder in the first quarter of 2024.

During the first quarter, the Company completed a registered public offering. Net proceeds from the raise, which closed on January 31, 2024, were approximately $8.1 million.

On May 15, 2024 Outlook Therapeutics, Inc., a biopharmaceutical company working to achieve regulatory approval for the first authorized use of an ophthalmic formulation of bevacizumab for the treatment of retinal diseases, reported financial results for the second quarter of fiscal year 2024 and provided a corporate update (Press release, Outlook Therapeutics, MAY 15, 2024, View Source [SID1234643335]). As previously announced, the Company will host its inaugural quarterly conference call and live audio webcast, on Thursday, May 16, 2024, at 8:30 AM ET (details below).

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"We are extremely pleased with our corporate, clinical, and regulatory progress. On the regulatory front, we continue to drive toward anticipated marketing authorization of ONS-5010 in the EU and have also submitted our marketing application for authorization in the UK. In the US, we are executing on our NORSE EIGHT clinical trial and advancing toward a topline data readout expected in the fourth quarter of calendar year 2024. On the financial front, assuming full exercise of the warrants issued in our recent private placement transactions, we believe we now have access to sufficient capital to take ONS-5010 through potential FDA approval and funding of the commercial launch," commented Russell Trenary, President and Chief Executive Officer of Outlook Therapeutics. "We remain steadfast in our mission to enhance the standard of care in the retinal anti-VEGF space. On behalf of the entire team, I would like to thank all our partners and stakeholders for their continued support and look forward to what we believe will be an exciting remainder of the year for Outlook Therapeutics."

Lawrence Kenyon, Chief Financial Officer of Outlook Therapeutics, added, "Our adjusted financial results for the quarter met our expectations as we initiated the NORSE EIGHT clinical trial and began enrolling patients. We believe we are well positioned financially to continue executing on NORSE EIGHT enrollment, resubmission of the ONS-5010 BLA by the end of calendar 2024, and launch of ONS 5010 in 2025, if approved."

Upcoming Anticipated Milestones

MAA decision in the European Union (EU) for ONS-5010 anticipated in Q2 CY2024;
Full enrollment of NORSE EIGHT clinical trial in the US expected in Q3 CY2024;
Topline readout of NORSE EIGHT clinical trial planned in Q4 CY2024;
Resubmission of the ONS-5010 BLA targeted for the end of CY2024;
Planning underway for potential commercial launches in the EU and UK to begin in first quarter of CY2025; and
Potential for US FDA approval of ONS-5010 in 2025.

ONS-5010 / LYTENAVA (bevacizumab-vikg) Regulatory Update

As previously announced, following Type A meetings with the FDA in Q4 CY2023, the FDA informed Outlook Therapeutics that it can conduct a non-inferiority study evaluating ONS-5010 versus ranibizumab in a 3-month study of treatment naïve patients with a primary efficacy endpoint at 2 months (NORSE EIGHT). In January 2024, Outlook Therapeutics announced that it received written agreement on the NORSE EIGHT trial protocol and statistical analysis plan from the FDA under a SPA for NORSE EIGHT. The SPA also confirms in writing that if the NORSE EIGHT trial is successful, it would satisfy the FDA’s requirement for a second adequate and well-controlled clinical trial to fully address the clinical deficiency identified in the Complete Response Letter (CRL). In addition, through a Type A meeting and additional interactions, Outlook Therapeutics has identified the approaches needed to resolve the Chemistry, Manufacturing and Controls (CMC) comments in the CRL. Outlook Therapeutics has scheduled a series of Type C and Type D meetings with the FDA to address the open CMC items in the CRL and expects to resolve these comments prior to the expected completion of NORSE EIGHT.

NORSE EIGHT is a randomized, controlled, parallel-group, masked, non-inferiority study of approximately 400 newly diagnosed, wet age-related macular degeneration (wet AMD) subjects randomized in a 1:1 ratio to receive 1.25 mg ONS-5010 or 0.5 mg ranibizumab intravitreal injections. Subjects will receive injections at Day 0 (randomization), Week 4, and Week 8 visits. The primary endpoint is mean change in BCVA from baseline to week 8. Currently, over 30% of the required subjects have been enrolled in the study. Outlook Therapeutics continues to plan NORSE EIGHT enrollment completion in Q3 CY2024, with topline results expected to be reported, and the planned resubmission of the ONS-5010 BLA to occur, by the end of calendar year 2024.

In March 2024, the CHMP issued a positive opinion concerning the EU Marketing Authorization Application (MAA) of ONS-5010/LYTENAVA (bevacizumab gamma), an investigational ophthalmic formulation of bevacizumab for the treatment of wet AMD in the EU. The CHMP positive opinion was based on results from Outlook Therapeutics’ wet AMD clinical program for ONS-5010, which consists of three completed registration clinical trials – NORSE ONE, NORSE TWO and NORSE THREE, as well as studies and peer reviewed literature substituting or supporting certain tests and studies.

This positive opinion supports the grant of marketing authorization by the European Commission for Outlook Therapeutics’ application for ONS-5010 in the EU. The European Commission is expected to make a decision on approval within approximately 67 days following the CHMP opinion. The decision will apply automatically in all 27 EU Member States, and, within 30 days, also to Iceland, Norway and Liechtenstein. If approved, an initial ten years of market exclusivity in the EU is expected for ONS-5010/LYTENAVA.

Additionally, the Company recently announced the submission of its MAA to the Medicines and Healthcare products Regulatory Agency (MHRA) in the UK seeking authorization of ONS-5010/LYTENAVA (bevacizumab gamma) for the treatment of wet AMD. The submission was completed under the new International Recognition Procedure (IRP), which allows the MHRA to rely on a positive opinion by the CHMP concerning an application for grant of marketing authorization for the same product in the EU. The IRP is available for new UK MAAs of a medicinal product (having the same qualitative and quantitative composition, and the same pharmaceutical form) that has previously been authorized by a Reference Regulator (RR). In this case this is the EMA.

If ONS-5010/LYTENAVA (bevacizumab-vikg or bevacizumab gamma) is approved, Outlook Therapeutics expects to commercialize it as the first and only European Commission, MHRA or FDA approved ophthalmic formulation of bevacizumab for use in treating retinal diseases in the EU, UK, and United States. Authorization may also be sought in other European markets, Japan, and elsewhere. If approved, Outlook Therapeutics plans to commercialize ONS-5010/LYTENAVA (bevacizumab-vikg) directly in the US and is assessing both direct commercialization and partnering for ONS-5010/LYTENAVA (bevacizumab gamma) in Europe and other regions outside of the US.

Financial Highlights for the Fiscal Second Quarter Ended March 31, 2024

For the fiscal second quarter ended March 31, 2024, Outlook Therapeutics reported a net loss attributable to common stockholders of $114.3 million, or $8.01 per basic and diluted share, compared to a net loss attributable to common stockholders of $6.7 million, or $0.52 per basic and diluted share, for the same period last year. For the fiscal second quarter ended March 31, 2024, Outlook Therapeutics also reported an adjusted net loss attributable to common stockholders1 of $22.1 million, or $1.55 per basic and diluted share, as compared to an adjusted net loss attributable to common stockholders of $6.7 million, or $0.52 per basic and diluted share, for fiscal second quarter 2023.

Adjusted net loss attributable to common stockholders for the fiscal second quarter ended March 31, 2024 includes $34.1 million of warrant related expenses, $49.6 million of increase in fair value of warrant liability and $8.5 million of increase in fair value of convertible promissory notes. Adjusted net loss attributable to common stockholders was not materially different than net loss attributable to common stockholders for the fiscal second quarter ended March 31, 2023.

In March and April 2024, the Company closed its previously announced private placements of common stock and accompanying warrants. In addition to the upfront gross proceeds of $65 million, the Company has the potential to receive additional gross proceeds of up to $107 million upon the full cash exercise of the warrants issued in the private placements, before deducting placement agent fees and offering expenses.

As of March 31, 2024, Outlook Therapeutics had cash and cash equivalents of $47.2 million.

On May 15, 2024 Oncolytics Biotech, a leading clinical-stage company specializing in immunotherapy for oncology, reported that it has entered into a preliminary collaboration with the Global Coalition for Adaptive Research (GCAR) (Press release, Oncolytics Biotech, MAY 15, 2024, View Source [SID1234643333]). The purpose of the preliminary collaboration is to commence planning activities for the evaluation of pelareorep in the treatment of first-line metastatic pancreatic ductal adenocarcinoma (PDAC) as part of GCAR’s anticipated master protocol for metastatic pancreatic cancer. Activities are currently underway to finalize the seamless Phase 2/3 master protocol design that will evaluate multiple investigational therapies for the treatment of pancreatic cancer. An intent of the study is to produce registration-enabling data.

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"We are thrilled to collaborate with GCAR and are honored that pelareorep has been selected as the first therapeutic for evaluation in GCAR’s planned adaptive trial in pancreatic cancer patients. We believe this opportunity presents a strategic and efficient pathway forward for the development of pelareorep to address an urgent need for pancreatic cancer patients," said Dr. Matt Coffey, President and Chief Executive Officer of Oncolytics. "GCAR’s anticipated trial design seeks to cut registrational study time and reduce trial costs, speeding up the journey to potentially deliver effective cancer treatment sooner. Through our interactions with GCAR, we have seen the strength of their capabilities and strong engagement with disease experts in pancreatic cancer. These attributes give us great enthusiasm to begin working together right away."

Meredith Buxton, PhD, MPH, Chief Executive Officer and President of GCAR, commented, "Our unwavering mission at GCAR is to accelerate the development of treatments for patients with deadly diseases such as pancreatic cancer. We believe that adaptive platform trials have the potential to achieve that mission and to be game-changing for patients. We are enthusiastic about collaborating with Oncolytics on our planned pancreatic cancer initiative, which was announced earlier this year, and we look forward to working with Oncolytics to advance our program."

Thomas Heineman, MD, PhD, Chief Medical Officer of Oncolytics shared, "The combination of pelareorep’s impressive results to date and GCAR’s innovative trial design creates a powerful path forward. This strategy, which includes leveraging GCAR’s extensive investigator network, enhances our ability to quickly and effectively advance the development of this pelareorep-based combination therapy for PDAC. Updated data from cohort 1 of the GOBLET study, presented at the European Society for Medical Oncology (ESMO) (Free ESMO Whitepaper) Congress 2023, showed that patients treated with pelareorep combined with a checkpoint inhibitor, gemcitabine, and nab-paclitaxel experienced a 62% objective response rate, nearly triple what has been seen in historical control trials.1-4 We hope to build on these results in GCAR’s forthcoming study that will employ GCAR’s broad and established network of clinical leaders in pancreatic cancer. I am very optimistic about our program and our collaboration with GCAR and look forward to advancing the evaluation of pelareorep as soon as possible."