Portage Biotech Reports Results for Fiscal Quarter Ended June 30, 2024 and Business Update

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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"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.

Mural Oncology to Present at Two Upcoming Investor Conferences

On August 27, 2024 Mural Oncology plc (Nasdaq: MURA), a clinical-stage immuno-oncology company developing novel, investigational engineered cytokine therapies designed to address areas of unmet need for patients with a variety of cancers, reported that members of its management team will participate at two upcoming investor conferences and take 1×1 meetings (Press release, Mural Oncology, AUG 27, 2024, View Source [SID1234646120]). A webcast of both presentations will be available at ir.muraloncology.com.

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Morgan Stanley 22nd Annual Global Healthcare Conference

Fireside chat with Caroline Loew, Ph.D., CEO, Vicki Goodman, MD, Chief Medical Officer, and Adam Cutler, Chief Financial Officer

Date: Friday, September 6

Time: 1:50 p.m. ET

H.C. Wainwright 26th Annual Global Investment Conference

Presentation by Caroline Loew, Ph.D.

Date: Wednesday, September 11

Time: 9:30 a.m. ET

MannKind to Present at Upcoming Conferences

On August 27, 2024 MannKind Corporation (Nasdaq: MNKD), a company focused on the development and commercialization of innovative inhaled therapeutic products and devices for patients with endocrine and orphan lung diseases, reported that Chief Executive Officer Michael Castagna, PharmD, and Chief Financial Officer Chris Prentiss will share updates during fireside chats at three upcoming investor conferences (Press release, Mannkind, AUG 27, 2024, View Source [SID1234646119]):

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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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2024 Wells Fargo Healthcare Conference in Boston
Wednesday, September 4
11:00 a.m. Eastern Time

Morgan Stanley 22nd Annual Global Healthcare Conference in New York
Friday, September 6
7:00 a.m. Eastern Time

H.C. Wainwright 26th Annual Global Investment Conference in New York
Tuesday, September 10
9:30 a.m. Eastern Time

Links to access live audio webcasts of the sessions will be available on MannKind Corporation’s website at: View Source An archived, recorded version will also be available on the website for approximately 30 days following each conference.

Lipocine to Present at H.C. Wainwright 26th Annual Global Investment Conference

On August 27, 2024 Lipocine Inc. (NASDAQ: LPCN), a biopharmaceutical company leveraging its proprietary technology platform to augment therapeutics through effective oral delivery, reported that Dr. Mahesh V. Patel, President and Chief Executive Officer, will present and meet with investors at the H.C. Wainwright 26th Annual Global Investment Conference being held in-person and virtually on September 9-11, 2024 (Press release, Lipocine, AUG 27, 2024, View Source [SID1234646118]).

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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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Presentation Details

Time: Available from 7:00 a.m. EDT onwards
Date: Monday, September 9, 2024
Webcast Link: View Source

Investors can register for the conference here. Those interested in arranging a 1×1 meeting with Lipocine should contact their H.C. Wainwright representative.

Delcath Systems, Inc. Announces Positive Outcomes from Independent Study on Hepatic Perfusion for Uveal Melanoma Patients

On August 27, 2024 Delcath Systems, Inc. (Nasdaq: DCTH) (the "Company" or "Delcath"), an interventional oncology company specializing in the treatment of primary and metastatic liver cancers, reported the publication of a retrospective study by independent investigators in the Annals of Surgical Oncology (Press release, Delcath Systems, AUG 27, 2024, View Source [SID1234646117]). The study, titled "Hepatic and Overall Progression-Free Survival After Percutaneous Hepatic Perfusion (PHP) as First-Line or Second-Line Therapy for Metastatic Uveal Melanoma," was conducted by researchers at Moffitt Cancer Center in Tampa, Florida. The 30-patient study reported that Delcath’s HEPZATO KIT (melphalan/Hepatic Delivery System (HDS)) provided better disease control in the liver and improved progression-free survival in patients with hepatic metastases from uveal melanoma, compared to both immunotherapy and other liver-directed therapies.

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Key Findings from the Study:

Overall Survival (OS): The study reported median OS of 22.4 months for patients treated with HEPZATO KIT as a first-line therapy (N=17) and 18.4 months as a second-line therapy (N=6).
Hepatic Progression-Free Survival (hPFS): Patients receiving HEPZATO KIT as first-line therapy had a median hPFS of 17.6 months (N=17), compared to 8.8 months (N=6) for immunotherapy and 9.2 months (N=7) for other liver-directed therapies. When used as a second-line therapy, HEPZATO KIT resulted in a median hPFS that was not reached (N=6), showing better outcomes than immunotherapy (14.7 months, N=5) and other liver-directed therapies (7.5 months, N=3) in this patient cohort.

Progression-Free Survival (PFS): The median overall PFS was 15.4 months (N=17) for patients receiving HEPZATO KIT as first-line therapy, compared to 8.8 months (N=6) for immunotherapy and 9.2 months (N=7) for other liver-directed therapies. In the second-line setting, HEPZATO KIT resulted in a median PFS of 22.2 months (N=6), compared to 14.7 months (N=5) for immunotherapy and 7.5 months (N=3) for other liver-directed therapies, reflecting longer disease control in this group.

Jonathan Zager, MD Chief Academic Officer and Director of Regional Therapies at Moffitt Cancer Center, remarked, "The findings from this study reaffirm the critical role of melphalan/HDS in managing liver-dominant metastatic uveal melanoma. These results highlight the potential benefits melphalan/HDS offers to patients, particularly in the context of first- and second-line treatments. My team is committed to further exploring the potential of combining melphalan/HDS with systemic therapies to continue improving patient outcomes."