On August 1, 2022 Navidea Biopharmaceuticals, Inc. (NYSE American: NAVB) ("Navidea" or the "Company"), a company focused on the development of precision immunodiagnostic agents and immunotherapeutics, reported a reminder to shareholders that the record date of its proposed rights offering is Wednesday, August 3, 2022 ("Record Date") (Press release, Navidea Biopharmaceuticals, AUG 1, 2022, View Source [SID1234617174]). To be a shareholder of record on the Record Date, ownership of Navidea stock must occur by market close on Monday, August 1, 2022 to account for settlement. Holders of certain of our outstanding warrants, Series D preferred stock and Series F preferred stock are also entitled to participate in the rights offering.

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The subscription rights will be non-transferable and may only be exercised during the anticipated subscription period of August 4, 2022 through 5:00 PM ET on August 17, 2022, unless extended by Navidea.

The expected calendar for the rights offering is as follows:

August 1, 2022: Ownership Day — in order to be considered a stockholder of record on August 3, shares should be acquired by this date.
August 3, 2022: Record Date
August 4, 2022: Distribution Date; Subscription Period Begins
August 17, 2022: Subscription Period Ends 5:00 PM ET (unless extended at Navidea’s sole discretion)
Holders who exercise their subscription rights in full will be entitled, if available, to subscribe for additional units that are not purchased by other stockholders, on a pro rata basis and subject to ownership limitations.

Navidea has engaged Maxim Group LLC as dealer-manager for the proposed rights offering. Questions about the rights offering or requests for copies of the preliminary and final prospectuses, when available, may be directed to Maxim Group LLC at 300 Park Avenue, New York, NY 10022, Attention Syndicate Department, or via email at [email protected] or telephone at (212) 895-3745.

A registration statement (Registration No. 333-262691) relating to these securities has been filed with the Securities and Exchange Commission ("SEC") but has not yet become effective. These securities may not be sold nor may offers to buy be accepted prior to the time the registration statement becomes effective. The rights offering, which is expected to commence following the effectiveness of the registration statement, is being made only by means of a written prospectus. A preliminary prospectus relating to and describing the proposed terms of the rights offering has been filed with the SEC as a part of the registration statement and is available on the SEC’s website at View Source Copies of the preliminary and final prospectuses for the rights offering may be obtained, when available, from Maxim Group LLC, 300 Park Avenue, New York, NY 10022, Attention Syndicate Department, email: [email protected] or telephone (212) 895-3745.

This press release does not constitute an offer to sell or the solicitation of an offer to buy these securities, nor will there be any sale of these securities in any state or other 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.

On August 1, 2022 Lantern Pharma Inc. (NASDAQ: LTRN), a clinical stage biopharmaceutical company using its proprietary RADR artificial intelligence (A.I.) and machine learning (ML) platform to transform the cost, pace, and timeline of oncology drug discovery and development, reported that it will host its second quarter 2022 financial results webcast on Monday, August 8th, 2022 at 4:30 p.m. Eastern Time / 1:30 p.m. Pacific Time (Press release, Lantern Pharma, AUG 1, 2022, View Source [SID1234617173]).

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Management intends to discuss the operating and financial results for the second quarter ended June 30, 2022 and provide guidance on upcoming milestones. Panna Sharma, President and Chief Executive Officer of Lantern Pharma, will lead the call and will be joined by other members of the management team.

A replay of the webinar will be available after the call on the investor relations section of the Company’s website: ir.lanternpharma.com.

On August 1, 2022 Aclaris Therapeutics, Inc. (NASDAQ: ACRS), a clinical-stage biopharmaceutical company focused on developing novel drug candidates for immuno-inflammatory diseases, reported the appointment of Douglas Manion, M.D., FRCP (C), as President and Chief Operating Officer (Press release, Aclaris Therapeutics, AUG 1, 2022, View Source [SID1234617172]). Dr. Manion will be responsible for overseeing day-to-day operations, continuing to develop Aclaris’ infrastructure and helping Aclaris develop its vision and overall strategic direction alongside Neal Walker, Aclaris’ CEO, and Aclaris’ board of directors.

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"We are excited to strengthen our leadership team by welcoming Dr. Manion to Aclaris," said Dr. Neal Walker, CEO of Aclaris. "Doug’s significant experience across the business, strong background in drug development, and track record of leading organizations, building teams and creating value for both large and small organizations will be extremely valuable as we continue to advance our drug development pipeline."

Dr. Manion brings over 25 years of pharmaceutical industry experience in both large and small companies. Most recently, he served as Executive Vice President of Research and Development at Arena Pharmaceuticals, Inc., where he oversaw all research and development activities until its acquisition by Pfizer Inc. Prior to that, Dr. Manion was the Chief Executive Officer of Kleo Pharmaceuticals, Inc., an immuno-oncology company, until its acquisition by Biohaven Pharmaceutical Holding Company Ltd. Dr. Manion’s previous biopharmaceutical experience included leadership roles at Bristol-Myers Squibb, GlaxoSmithKline, DuPont Pharmaceuticals and DuPont Merck Pharmaceuticals.

"Aclaris is at an exciting stage in its life, and I am thrilled to join the organization," said Dr. Manion. "I look forward to leveraging my strengths in helping Aclaris grow and execute on its strategy."

Dr. Manion’s appointment is effective August 1, 2022. In connection with his appointment, Dr. Walker will no longer serve as the President, but will continue to serve as Aclaris’ Chief Executive Officer.

On August 1, 2022 Innate Pharma SA (Euronext Paris: IPH; Nasdaq: IPHA) ("Innate" or the "Company"), reported that a planned futility interim analysis of the INTERLINK-1 Phase 3 study sponsored by AstraZeneca (LSE/STO/Nasdaq: AZN) did not meet a pre-defined threshold for efficacy (Press release, Innate Pharma, AUG 1, 2022, View Source [SID1234617171]). Based on this result and the recommendation of an Independent Data Monitoring Committee, AstraZeneca has informed Innate that the study will be discontinued. There were no new safety findings. AstraZeneca plan to share the data in due course.

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The INTERLINK-1 study, sponsored by AstraZeneca, evaluated monalizumab in combination with cetuximab vs. cetuximab in patients with recurrent or metastatic squamous cell carcinoma of the head and neck (R/M SCCHN) who have been previously treated with platinum-based chemotherapy and PD-(L)1 inhibitors.

"The INTERLINK-1 Phase 3 study was intended to further evaluate a novel immunotherapy regimen following the promising signals observed in a non-randomized Phase 1b/2 study of head and neck cancer. While we are disappointed with the outcome of this study, the findings are certain to advance our understanding of the role of immunotherapy in this setting," said Mondher Mahjoubi, Chief Executive Officer of Innate Pharma. "We remain confident in the development program for monalizumab in lung cancer, where encouraging data has been previously reported from the randomized, Phase 2 COAST and Neo-COAST studies. Our focus for monalizumab remains on the Phase 3 PACIFIC-9 study in the unresectable Stage III non-small cell lung cancer setting, as well as the Phase 2 NeoCOAST-2 study in the neoadjuvant early-stage lung cancer setting."

Susan Galbraith, Executive Vice President, Oncology R&D, AstraZeneca, said: "We are disappointed by this outcome and what it means for patients. We would like to thank the patients, investigators and healthcare professionals who dedicated their time and expertise to this trial, which has advanced our understanding of metastatic head and neck cancer. We continue to explore the impact of monalizumab in patients with non-small cell lung cancer across different trials, including the Phase 3 PACIFIC-9 trial."

Monalizumab, Innate’s lead partnered asset, is a potentially first-in-class immune checkpoint inhibitor targeting NKG2A receptors expressed on tumor infiltrating cytotoxic CD8+ T cells and NK cells. It is being studied in a Phase 3 clinical study sponsored by AstraZeneca, PACIFIC-9, evaluating durvalumab (PD-L1) in combination with monalizumab or AstraZeneca’s oleclumab (anti-CD73) in patients with unresectable, Stage III non-small cell lung cancer (NSCLC) who have not progressed following definitive platinum-based concurrent chemoradiation therapy.

About INTERLINK-1:

INTERLINK-1 was a global, multi-center, randomized, double-blind Phase 3 study of monalizumab and cetuximab vs. placebo and cetuximab designed to enroll approximately 600 patients with recurrent or metastatic squamous cell carcinoma of the head and neck (R/M SCCHN) who have been previously treated with platinum-based chemotherapy and PD-(L)1 inhibitors ("IO-pretreated").

The primary endpoint was overall survival (OS) in HPV-unrelated participants, with secondary endpoints including OS in all randomized participants, progression-free survival (PFS), overall response rate, duration of response, safety and quality of life. Additional details on the INTERLINK-1 clinical study can be found here.

About monalizumab:

Monalizumab is a potentially first-in-class immune checkpoint inhibitor targeting NKG2A receptors expressed on tumor infiltrating cytotoxic CD8+ T cells and NK cells.

NKG2A is an inhibitory checkpoint receptor for HLA-E. By expressing HLA-E, cancer cells can protect themselves from killing by NKG2A+ immune cells. HLA-E is frequently overexpressed in the cancer cells of many solid tumors and hematological malignancies. Monalizumab may reestablish a broad anti-tumor response mediated by NK and T cells, and may enhance the cytotoxic potential of other therapeutic antibodies.

The ongoing development for monalizumab is focused on investigating monalizumab in various combination strategies in different malignancies, including, in early lung cancer, the Phase 3 PACIFIC-9 study in adults with locally advanced (Stage III), unresectable NSCLC, who have not progressed following platinum-based concurrent chemoradiotherapy, and the Phase 2 NeoCOAST-2 study in the neoadjuvant early-stage setting of NSCLC.

About the Innate-AstraZeneca monalizumab agreement:

In October 2018, AstraZeneca obtained full oncology rights to monalizumab by exercising its option under the co-development and commercialization agreement initiated in 2015.

The financial terms of the agreement include potential cash payments up to $1.275 billion to Innate Pharma. Including the $50 million payment triggered by dosing the first patient in the Phase 3 PACIFIC-9 clinical study, Innate Pharma has received $450 million to date.

For any commercialized oncology indication, AstraZeneca will book all sales revenue and will pay Innate low double-digit to mid-teen percentage royalties on net sales worldwide except in Europe where Innate Pharma will receive 50% share of the profits and losses in the territory. Innate co-fund 30% of the costs of the Phase 3 development program of monalizumab with a pre-agreed limitation of Innate’s financial commitment.

On August 1, 2022 Exact Sciences Corp. (Nasdaq: EXAS), a leading provider of cancer screening and diagnostic tests, reported that company management will participate in the following conference and invited investors to participate by webcast (Press release, Exact Sciences, AUG 1, 2022, View Source [SID1234617170]).

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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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UBS Genomics 2.0 and MedTech Innovations Summit, Dana Point
Fireside chat on Wednesday, August 10, 2022 at 4:00 p.m. ET
The webcast can be accessed in the investor relations section of Exact Sciences’ website at www.exactsciences.com.