On August 27, 2024 Rezolute, Inc. (Nasdaq: RZLT) ("Rezolute" or the "Company"), a late-stage rare disease company focused on significantly improving outcomes for individuals with hypoglycemia caused by hyperinsulinism (HI), reported that management will participate in the following investor conferences (Press release, Rezolute, AUG 27, 2024, View Source [SID1234646126]):

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Event: H.C. Wainwright 26th Annual Global Investment Conference
Date: September 9-11, 2024

Event: Cantor Global Healthcare Conference
Date: September 17-19, 2024

Management will be participating in one-on-one investor meetings throughout the conferences. Investors interested in scheduling a meeting with the Rezolute management team should contact their H.C. Wainwright and Cantor representatives.

On August 27, 2024 Autolus Therapeutics plc (Nasdaq: AUTL), a clinical-stage biopharmaceutical company developing next-generation programmed T cell therapies, reported a poster presentation at the Society of Hematologic Oncology (SOHO) Annual Meeting being held September 4-7, 2024 in Houston, Texas (Press release, Autolus, AUG 27, 2024, View Source [SID1234646125]). These data demonstrate the rationale for tumor burden (TB)-guided dosing in adult patients with Relapsed/Refractory B-Cell Acute Lymphoblastic Leukemia (r/r B-ALL) by analyzing the impact of bone marrow (BM) blast percentage prior to lymphodepletion in patients treated with obe-cel in the FELIX Phase 1b/2 study.

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"Unlike other CD19 CAR T-cell therapies, obe-cel is administered to patients as two infusions using a tumor burden-guided dosing schedule," said Dr. Christian Itin, Chief Executive Officer of Autolus. "The data demonstrate the importance of administering both split doses of obe-cel to patients with r/r B-ALL and highlight the differentiation of obe-cel based on its unique binding properties and tumor burden-guided dosing approach."

Poster presentation:
Title: Obecabtagene autoleucel (obe-cel) for Relapsed/Refractory Adult B-Cell Acute Lymphoblastic Leukemia (r/r B-ALL): Impact of Chimeric Antigen Receptor T-Cell (CAR T) and Tumor Burden-Guided Dosing in the FELIX Phase 1b/2 Study

Session date and time: Wednesday, September 4, 6:15 pm
Session room: Hall B3
Poster Number: ALL-502
Presenting Author: Dr. Elias Jabbour, Professor, Department of Leukemia, Division of Cancer Medicine, MD Anderson Cancer Center, Houston, TX

Summary:
Tumor burden (TB) is a recognized driver of immunotoxicity from CAR T therapy for B-ALL. Obe-cel is a novel autologous CAR T with a differentiated fast off-rate CD19 binding domain and a 4-1BB co-stimulatory domain, designed to improve CAR T persistence and immunotoxicity. Obe-cel is an investigational therapy being evaluated in adult r/r B-ALL in the FELIX Phase Ib/II study (NCT04404660), utilizing TB-guided dosing based on bone marrow (BM) blast percentage prior to lymphodepletion. We report outcomes by TB, demonstrating the rationale for TB-guided dosing in adult r/r B-ALL.

Of 127 patients infused with obe-cel, 120 (94%) received the planned two doses (low TB: n=48 [40%]; high TB: n=72 [60%]). Overall, high CAR T expansion was observed, which progressively increased with TB; a TB increase of 50% was associated with a 1.754-fold increase in Cmax and a 2.068-fold increase in AUC0–28days. In both groups, peak expansion was reached after Dose 2 (low/high TB: Day 15 [6–55]/Day 11 [2–28]), demonstrating the need for both doses regardless of TB. Overall remission rate was 90% and 75% in low and high TB groups, respectively.

In summary, TB-guided dosing was associated with high CAR-T cell expansion and while providing a manageable adverse event profile. This supports the TB guided-dosing approach in adult r/r B-ALL.

On August 27, 2024 Syros Pharmaceuticals (NASDAQ:SYRS), a biopharmaceutical company committed to advancing new standards of care for the frontline treatment of hematologic malignancies, reported that it will present additional data from the randomized portion of the SELECT-AML-1 Phase 2 clinical trial at the Society of Hematologic Oncology (SOHO) Annual Meeting taking place September 4-7, in Houston, Texas (Press release, Syros Pharmaceuticals, AUG 27, 2024, View Source [SID1234646123]). Additionally, Syros announced that company management will participate in the H.C. Wainwright 26th Annual Global Investment Conference, being held September 9-11 in New York City.

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Details are as follows:

12th Annual Meeting of the Society of Hematologic Oncology (SOHO 2024)

Presentation Title: SELECT-AML-1: Phase 2 Randomized Trial of Tamibarotene in Combination With Venetoclax and Azacitidine in Adult Patients With Previously Untreated AML With RARA Overexpression, Who Are Ineligible for Standard Induction Therapy
Session Date & Time: Wednesday, September 4, 2024, 5:15-6:30 PM CT (6:15-7:30 PM ET)
Location: George R. Brown Convention Center
Poster Number: AML-347

The poster will be available on the Publications and Abstracts section of the Syros website at www.syros.com following the session.

H.C. Wainwright 26th Annual Global Investment Conference

Presentation Date & Time: Monday, September 9, 2024, 11:30 AM ET
Location: Lotte New York Palace

A live webcast of the presentation will be available on the Investors & Media section of the Syros website at www.syros.com. An archived replay of the webcast will be available for approximately 30 days following the presentation.

On August 27, 2024 Privo Technologies reported the receipt of $4.5 million in funding from the National Cancer Institute to support our pivotal Phase 3 clinical trial for a groundbreaking nanotechnology-based treatment targeting carcinoma in situ of the oral cavity (Stage 0 oral cancer) (Press release, Privo Technologies, AUG 27, 2024, View Source;utm_medium=rss&utm_campaign=privo-technologies-receives-4-5m-funding-from-national-cancer-institute-for-phase-3-clinical-trial-of-innovative-oral-cancer-treatment [SID1234646122]). This funding is a critical milestone in our journey toward seeking regulatory approval for PRV111, our innovative treatment designed to revolutionize the standard of care for patients with rare, orphan diseases.

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The continued support from the National Cancer Institute not only affirms the potential of our technology but also accelerates our ability to move forward in the regulatory process. With these resources, Privo can conduct the necessary research and clinical studies to demonstrate the safety and efficacy of our treatment, bringing us closer to delivering new therapies to patients who have limited options. This funding is instrumental in advancing our mission to make a meaningful impact on the lives of those battling rare forms of cancer, as we strive to bring this promising treatment to market.

On August 27, 2024 Portage Biotech Inc. ("Portage" or the "Company") (NASDAQ: PRTG), a clinical-stage immuno-oncology company with a portfolio of novel multi-targeted therapies for use as monotherapy and in combination, reported its financial results for the fiscal quarter ended June 30, 2024 (Press release, Portage Biotech, AUG 27, 2024, View Source [SID1234646121]).

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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 continue to explore strategic alternatives. These may include finding a partner for one or more of our assets, a sale of our company, a merger, restructurings (both in and out of court), a company wind down, further financing efforts, or other strategic actions," said Dr. Ian Walters, Chief Executive Officer and Chairman of Portage. "We are encouraged by the two advanced patients that continue on PORT-6 beyond 6 months who we continue to follow, and we plan to replace one patient in the ADPORT-601 trial who withdrew prior to dose limiting toxicity assessment for an unrelated adverse event. We also continue our collaborations with numerous experts to further understand the biology and utility of our product candidates," continued Dr. Walters.

Financial Results for the Quarter Ended June 30, 2024

The Company incurred a net loss of approximately $1.7 million during the three months ended June 30, 2024 (the "Fiscal 2025 Quarter"), compared to a net loss of approximately $4.2 million during the three months ended June 30, 2023 (the "Fiscal 2024 Quarter"), representing a $2.5 million decrease in net loss.

Operating expenses, including research and development ("R&D") costs and general and administrative ("G&A") expenses, were $2.8 million in the Fiscal 2025 Quarter, down from $5.0 million in the Fiscal 2024 Quarter, a decrease of $2.2 million, as detailed below.

R&D costs decreased by approximately $2.3 million, or 64%, from $3.6 million in the Fiscal 2024 Quarter, to $1.3 million in the Fiscal 2025 Quarter. This reduction was primarily due to the winding down of clinical trial costs (principally CRO-related), which decreased by $0.3 million, from $1.0 million in the Fiscal 2024 Quarter to $0.7 million in the Fiscal 2025 Quarter, as the Company paused enrollment in its sponsored clinical trials in the third and fourth quarters of the fiscal year ended March 31, 2024. Manufacturing-related costs decreased by $0.7 million, from $0.8 million in the Fiscal 2024 Quarter to $0.1 million in the Fiscal 2025 Quarter. These decreases reflect reduced clinical activity and manufacturing costs following the Company’s decision to discontinue the iNKT program and pause further patient accrual in the adenosine program. Additionally, R&D non-cash share-based compensation expense decreased from $0.4 million in the Fiscal 2024 Quarter to nil in the Fiscal 2025 Quarter. Payroll-related expenses also decreased by $0.2 million, from $0.5 million in the Fiscal 2024 Quarter to $0.3 million in the Fiscal 2025 Quarter, due to the resignation of two employees in January 2024. Further, in the Fiscal 2024 Quarter, the Company incurred a $0.5 million milestone payment for dosing its first adenosine patients. Consulting fees decreased by $0.1 million, from $0.2 million in the Fiscal 2024 Quarter to $0.1 million in the Fiscal 2025 Quarter, reflecting the decline in consulting-related activity. Lastly, there was a $0.1 million decrease in fees paid related to the transition of the iNKT study before its discontinuation.

G&A expenses increased by $0.1 million, or 7%, from $1.4 million in the Fiscal 2024 Quarter to $1.5 million in the Fiscal 2025 Quarter. Professional fees increased by $0.1 million, from $0.5 million in the Fiscal 2024 Quarter to $0.6 million in the Fiscal 2025 Quarter, primarily due to legal fees associated with regulatory filings, corporate matters, and related audit fees. Payroll-related expenses increased by $0.4 million from $0.2 million in the Fiscal 2024 Quarter to $0.6 million in the Fiscal 2025 Quarter due to the amounts associated with retention agreements executed with an employee and a consultant. Additionally, G&A non-cash share-based compensation expense decreased by $0.2 million due to the continued vesting of stock options with higher fair values, partially offset by recording all Fiscal 2025 Quarter share-based compensation expense as G&A expenses as the result of the discontinuation of the iNKT study and the pause of further patient accrual in the adenosine program. Directors’ fees also decreased by $0.1 million in the Fiscal 2025 Quarter, as all directors, except for two who resigned in April 2024, waived their fees.

The primary reasons for the quarter-over-quarter differences in the Company’s pre-tax items of income and expense were the $1.1 million non-cash gain from the change in the fair value of certain warrants accounted for as liabilities, issued in connection with an equity offering in October 2023, in the Fiscal 2025 Quarter, and the non-cash loss from the increase in the fair value of the deferred purchase price payable to the former Tarus shareholders and the deferred obligation for the iOx milestone, totaling $1.1 million, in the Fiscal 2024 Quarter.

As of June 30, 2024, the Company had cash and cash equivalents of approximately $3.3 million and total current liabilities of approximately $3.0 million.