Privo Technologies Receives $4.5M Funding from National Cancer Institute for Phase 3 Clinical Trial of Innovative Oral Cancer Treatment

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.

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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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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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.