On September 7, 2023 Strata Oncology, Inc. ("Strata"), a next-generation precision oncology company enabling smarter and earlier cancer treatment, reported new data showing its proprietary biomarker algorithm, Immunotherapy Response Score (IRS), supports informed clinical decisions for first-line treatment of patients with non-small cell lung cancer (NSCLC) beyond the standard of care biomarker PD-L1 immunohistochemistry (IHC) (Press release, Strata Oncology, SEP 7, 2023, View Source [SID1234635003]).

Schedule your 30 min Free 1stOncology Demo!
Discover why more than 1,500 members use 1stOncology™ to excel in:

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

                  Schedule Your 30 min Free Demo!

The data from Kaiser Permanente Northern California — the first of its kind for first-line treatment of patients with NSCLC — will be presented at the 2023 World Conference on Lung Cancer in Singapore on Sunday, September 10, 2023 in the Pathology and Biomarkers – Biomarkers for Immuno-Oncology poster session from 5:30 PM to 7:30 PM SGT.

A pre-specified blinded analysis of more than 200 NSCLC patients initially treated with pembrolizumab either alone or in combination with chemotherapy, showed that IRS was significantly associated with time-to-next-treatment (TTNT) independent of therapy type and PD-L1 IHC by tumor proportion score (TPS). Subgroup analysis demonstrated that among patients with PD-L1 High (TPS>=50%), IRS High patients had significantly longer single-agent pembrolizumab TTNT than IRS Low patients, illustrating the opportunity to fill a clear unmet need.

"In NSCLC with PD-L1 TPS>=50%, guidelines recommend either pembrolizumab alone or in combination with chemotherapy. IRS can potentially guide treatment selection in this important and frequent clinical scenario," said Kat Kwiatkowski, Ph.D., Strata Oncology SVP, Clinical Development. "Given the significant difference between IRS groups, IRS High status would favor treatment with pembrolizumab alone, whereas IRS Low status would favor combination therapy."

IRS has been validated as a pan-solid tumor predictive biomarker for anti-PD-1/PD-L1 checkpoint inhibitor monotherapy benefit in multiple studies, most recently in a publication in Cancer Research Communications, where the clinical utility of IRS beyond standard biomarkers used to guide anti-PD-1/PD-L1 therapy, including tumor mutation burden (TMB), microsatellite instability (MSI) and PD-L1 IHC was shown. This study also demonstrated the clinical utility of IRS as a useful tool to help guide the choice between chemotherapy alone, anti-PD-1/PD-L1 monotherapy, or anti-PD-1/PD-L1 in combination with chemotherapy, across five tumor types where this is a critical treatment decision.

"Our Immunotherapy Response Score meets a significant unmet medical need for an integrative diagnostic test that can predict benefit across tumor types, and in this case, specifically help clinicians make informed decisions for first-line treatment of patients with NSCLC," said Scott Tomlins, M.D., Ph.D., Strata Oncology co-founder and Chief Medical Officer. "This new data marks significant progress in the effort to provide clinicians with the ability to make accurate and precise treatment recommendations that patients with NSCLC require."

Immunotherapy Response Score is available clinically as part of the Strata SelectTM test, which is covered for Medicare beneficiaries with advanced solid tumors seeking additional treatment. Learn more at View Source

On September 7, 2023 Oncolytics Biotech Inc. ("Oncolytics" or the "Company") (NASDAQ: ONCY) (TSX: ONC) reported that in connection with the previously announced underwritten public offering of US$15,000,750 (the "Offering") and the underwriting agreement dated August 1, 2023 (the "Underwriting Agreement"), Leede Jones Gable Inc. (the "Underwriter") has exercised their option (the "Over-Allotment Option"), in full, to purchase 1,000,050 units (the "Optioned Units") at US$2.25 for aggregate gross proceeds of US$2,250,112 (Press release, Oncolytics Biotech, SEP 7, 2023, View Source [SID1234635002]). The Company intends to use the proceeds from the Offering to continue the advancement of its pelareorep clinical programs in metastatic breast and pancreatic cancers, as well as general corporate and working capital purposes.

Schedule your 30 min Free 1stOncology Demo!
Discover why more than 1,500 members use 1stOncology™ to excel in:

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

                  Schedule Your 30 min Free Demo!

Each Optioned Unit consists of one common share of the Company (each a "Common Share") and one Common Share purchase warrant (each a "Warrant"). Each Warrant entitles the holder thereof to purchase one Common Share at an exercise price of US$2.81 at any time up to 60 months following the Closing, subject to acceleration in certain circumstances. Pursuant to the Underwriting Agreement, in consideration for the services rendered by the Underwriter in connection with the Offering, the Company paid to the Underwriter a cash commission equal to 7.0% of the aggregate gross proceeds raised from the Offering and issued to the Underwriter such number of compensation warrants (the "Compensation Warrants") as is equal to 7.0% of the aggregate number of Optioned Units sold in the Offering. Each Compensation Warrant is exercisable into one Common Share (an "Underwriter’s Warrant Share") at an exercise price of US$2.25 per Underwriter’s Warrant Share at any time up to 60 months following the Closing.

The Offering is being made by way of a prospectus supplement to the Company’s short form base shelf prospectus filed on August 1, 2023 in each of the provinces and territories of Canada, except Quebec, pursuant to National Instrument 44-101 – Short Form Prospectus Distributions and National Instrument 44-102 – Shelf Distributions.

The securities referred to in this news release have not been, nor will they be, registered under the United States Securities Act of 1933, as amended, and may not be offered or sold within the United States or to, or for the account or benefit of, U.S. persons absent U.S. registration or an applicable exemption from the U.S. registration requirements. This press release does not constitute an offer for sale of securities, nor a solicitation for offers to buy any securities in the United States, nor in any other jurisdiction in which such offer, solicitation or sale would be unlawful. Any public offering of securities in the United States must be made by means of a prospectus containing detailed information about the company and management, as well as financial statements.

On September 7, 2023 Mustang Bio, Inc. ("Mustang") (Nasdaq: MBIO), a clinical-stage biopharmaceutical company focused on translating today’s medical breakthroughs in cell and gene therapies into potential cures for difficult-to-treat cancers and rare genetic diseases, reported that Manuel Litchman, M.D., President and Chief Executive Officer, will participate in two upcoming investor conferences in New York City (Press release, Mustang Bio, SEP 7, 2023, View Source [SID1234635001]).

Schedule your 30 min Free 1stOncology Demo!
Discover why more than 1,500 members use 1stOncology™ to excel in:

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

                  Schedule Your 30 min Free Demo!

Details of the events are as follows:

H.C. Wainwright 25th Annual Global Investment Conference: The company will present a corporate update on Monday, September 11, 2023, at 3:30 p.m. ET and will participate in one-on-one meetings during the conference.

2023 Cantor Fitzgerald Global Healthcare Conference: The company will participate in a panel presentation on Wednesday, September 27, 2023, at 8:35 a.m. ET and will participate in one-on-one meetings during the conference.

A webcast and subsequent archived replay of each of the company’s presentations will be available on the News & Events page of the Investor Relations section of Mustang’s website, www.mustangbio.com, for approximately 30 days after each meeting.

On September 7, 2023 Adamis Pharmaceuticals Corporation (NASDAQ: ADMP), a commercial-stage biopharmaceutical company, reported the company changed its name to DMK Pharmaceuticals Corporation in order to better reflect its new strategic focus on advancing small molecules for the treatment of substance use disorders (Press release, Adamis Pharmaceuticals, SEP 7, 2023, View Source [SID1234635000]). In conjunction with the name change, the company’s common stock is expected to trade under the new Nasdaq ticker symbol "DMK" on or about September 8, 2023. The CUSIP number for the common stock, 00547W307, will remain unchanged.

Schedule your 30 min Free 1stOncology Demo!
Discover why more than 1,500 members use 1stOncology™ to excel in:

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

                  Schedule Your 30 min Free Demo!

"The new DMK Pharmaceuticals is committed to developing groundbreaking and innovative therapies to establish itself as a leader in the treatment of substance abuse including opioid and alcohol use disorders," said Eboo Versi, MD, PhD, CEO of Adamis, "Rebranding the company signifies our new strategic vision and reinforces our commitment to a renewed corporate strategy. Along with our flagship approved treatment for emergency treatment of opioid overdose, ZIMHI, our lead clinical stage compound, DPI-125 will be our core focus. DPI-125 is a novel molecule for the treatment of opioid use disorder. Currently approved therapies are old and the vast majority of sufferers are not getting this medical treatment. I believe this is because they have unfavorable drug scheduling resulting in limited access, and in many cases, patients have to undergo opioid withdrawal symptoms prior to starting treatment. It is my belief that DPI-125, if successfully developed, will receive a more favorable drug scheduling and be a more ‘patient friendly’ treatment. DPI-125 is also being developed for the treatment of moderate to severe pain. If clinical studies confirm what we suspect from animal studies, this drug will not be addictive and as such could even help to reduce the incidence of opioid use disorder."

DMK expects several potential significant milestones for DPI-125 by the end of 2024 including: manufacture of a transdermal delivery system; results of a respiratory depression safety study compared to fentanyl; results of a pharmacokinetic study in humans; and results of an abuse liability study compared to current treatments for OUD and pain relief, in each case assuming the availability of adequate funding and no unexpected developments or delays. There can be no assurances that any of these milestones will be achieved or will be achieved within the anticipated time periods.

On September 7, 2023 Gilead Sciences, Inc. (Nasdaq: GILD), a biopharmaceutical company that has pursued and achieved breakthroughs in medicine for more than three decades, reported the pricing of senior unsecured notes in an aggregate principal amount of $2 billion, in an underwritten, registered public offering, consisting of $1 billion of 5.250% senior notes maturing in 2033 and $1 billion of 5.550% senior notes maturing in 2053 (Press release, Gilead Sciences, SEP 7, 2023, View Source [SID1234634999]). The offering is expected to close September 14, 2023, subject to customary closing conditions.

Schedule your 30 min Free 1stOncology Demo!
Discover why more than 1,500 members use 1stOncology™ to excel in:

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

                  Schedule Your 30 min Free Demo!

Gilead intends to use the net proceeds from this offering for general corporate purposes.

Barclays Capital Inc. and Citigroup Global Markets Inc. are acting as lead joint book-running managers in the offering. The offering of the securities is being made only by means of a prospectus supplement and the accompanying base prospectus, which is filed as part of Gilead’s effective shelf registration statement on Form S-3 (File No. 333-273745), copies of which may be obtained from:

Barclays Capital Inc.

c/o Broadridge Financial Solutions,

1155 Long Island Avenue

Edgewood, NY 11717

(888) 603-5847

Email: [email protected]

Citigroup Global Markets Inc.

c/o Broadridge Financial Solutions,

1155 Long Island Avenue

Edgewood, NY 11717

(800) 831-9146

Email: [email protected]

An electronic copy of the prospectus supplement and the accompanying base prospectus and other documents Gilead has filed with the U.S. Securities and Exchange Commission ("SEC") may also be obtained at no charge at the SEC’s website at www.sec.gov. This press release does not constitute an offer to sell or the solicitation of an offer to buy any of the securities, nor shall there be any sale of these securities 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.