Entry into a Material Definitive Agreement

On November 19, 2021, Xenetic Biosciences, Inc. (the "Company") reported that entered into an At The Market Offering Agreement (the "ATM Agreement") with H.C. Wainwright & Co., LLC, as the exclusive sales agent ("Wainwright"), pursuant to which the Company may offer and sell, from time to time through Wainwright, shares (the "Shares") of its common stock, par value $0.001 per share ("Common Stock") (Filing, 8-K, Xenetic Biosciences, NOV 19, 2021, View Source [SID1234595845]). The offer and sale of the Shares will be made pursuant to a shelf registration statement on Form S-3 (File No. 333-260201) and the related prospectus, as supplemented by a prospectus supplement dated November 19, 2021 (the "Prospectus Supplement") and filed with the Securities and Exchange Commission (the "SEC") on such date pursuant to Rule 424(b) under the Securities Act of 1933, as amended (the "Securities Act"), and is currently limited to a number of Shares of up to $4,000,000 of Common Stock pursuant to General Instruction I.B.6 of Form S-3.

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Pursuant to the ATM Agreement, Wainwright may sell the Shares in sales deemed to be "at-the-market" equity offerings as defined in Rule 415 promulgated under the Securities Act, including sales made directly on or through the Nasdaq Capital Market. If agreed to in a separate terms agreement, the Company may sell Shares to Wainwright as principal, at a purchase price agreed upon by Wainwright and the Company. Wainwright may also sell Shares in privately negotiated transactions with the Company’s prior approval. Sales of the Shares through Wainwright, if any, will be made in amounts and at times to be determined by the Company from time to time, but the Company has no obligation to sell any of the Shares and either the Company or Wainwright may at any time suspend offers under the Agreement or terminate the Agreement. Actual sales will depend on a variety of factors to be determined by the Company from time to time, including (among others) market conditions, the trading price of the Company’s common stock and determinations by the Company of the appropriate sources of funding for the Company. The offer and sale of the Shares pursuant to the ATM Agreement will terminate upon the earlier of (a) the issuance and sale of all of the Shares subject to the ATM Agreement or (b) the termination of the ATM Agreement by Wainwright or the Company pursuant to the terms thereof.

The Sales Agreement provides that Wainwright will be entitled to compensation of up to 3.0% of the gross sales price of any Shares sold by Wainwright under the Sales Agreement. The Company also will reimburse Wainwright for certain specified expenses in connection with entering into the ATM Agreement. The Company has agreed to provide Wainwright with customary indemnification and contribution rights, including for liabilities under the Securities Act. The ATM Agreement contains customary representations and warranties and conditions to the placements of the Shares pursuant thereto.

A copy of the ATM Agreement is filed as Exhibit 1.1 to this Current Report on Form 8-K, and the description of the terms of the ATM Agreement is qualified in its entirety by reference to such exhibit. A copy of the opinion of Westward Law LLC relating to the legality of the issuance and sale of the Shares is attached as Exhibit 5.1 hereto.

This Current Report on Form 8-K shall not constitute an offer to sell or the solicitation of an offer to buy the Shares, nor shall there be any offer, solicitation, or sale of the Shares in any state in which such offer, solicitation or sale would be unlawful prior to registration or qualification under the securities laws of any such state.

Zymeworks Announces Abstract for Zanidatamab in Late-Line HER2-Positive
Breast Cancer at the San Antonio Breast Cancer Symposium (SABCS)

On November 19, 2021 Zymeworks Inc. (NYSE: ZYME), a clinical-stage biopharmaceutical company developing multifunctional biotherapeutics, reported the publication of an abstract highlighting new clinical data for zanidatamab, a HER2-targeted bispecific antibody (Press release, Zymeworks, NOV 19, 2021, View Source [SID1234595844]). Zanidatamab in combination with chemotherapy was well tolerated, with encouraging and durable antitumor activity in heavily pretreated patients with HER2-positive breast cancer. A poster with an updated and expanded data set will be presented at SABCS taking place in San Antonio, Texas and virtually on December 7-10, 2021. In addition, Zymeworks will present a Trial in Progress poster detailing the ongoing clinical trial evaluating zanidatamab in combination with the CD47-blocker, evorpacept (ALX148).

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SABCS Data Presentation

Abstract highlights from May 3, 2021 data cut:

Twenty heavily pretreated HER2-positive breast cancer patients had been treated with zanidatamab in combination with standard of care chemotherapy (either vinorelbine, capecitabine, or paclitaxel).

The confirmed objective response rate was 37.5% and the disease control rate was 81.3% in 16 response-evaluable patients.

Treatment-related adverse events were generally consistent with previous reports of zanidatamab and/or the chemotherapy regimens, with the majority reported as Grade 1 or 2 in severity.

The abstract is available on the SABCS conference website. The presentation will be available on Wednesday, December 8 at 5:00 pm CT to conference registrants on the SABCS conference website as well as to the general public on the Zymeworks website.

Title: Zanidatamab (ZW25), a HER2-targeted bispecific antibody, in combination with chemotherapy (chemo) for HER2-positive breast cancer (BC): Results from a phase 1 study Lead Author: Philippe L. Bedard, M.D., Princess Margaret Cancer Center, Toronto, ON Canada Abstract: #93

Program Number: P2-13-07

Trials in Progress Presentation

The abstract is available on the SABCS conference website. The presentation will be available on Wednesday, December 8 at 5:00 pm CT to conference registrants on the SABCS conference website as well as to the general public on the Zymeworks website.

Title: Zanidatamab in combination with ALX148 in advanced Human Epidermal Growth Factor Receptor 2 (HER2)-expressing cancers, including breast cancer: a phase 1b/2, multicenter, open-label, dose-finding and cohort-expansion study (ZWI-ZW25-204)

Lead Author: Sara A. Hurvitz, M.D., University of California, Los Angeles; Jonsson Comprehensive Cancer Center, Los Angeles, CA, US

Abstract: #182

Program Number: OT1-14-01

About Zanidatamab

Zanidatamab is a bispecific antibody, based on Zymeworks’ Azymetric platform, that can simultaneously bind two non-overlapping epitopes of HER2, known as biparatopic binding. Zanidatamab’s unique binding properties result in multiple mechanisms of action including HER2-receptor clustering, internalization, and downregulation; inhibition of growth factor- dependent and -independent tumor cell proliferation; antibody-dependent cellular cytotoxicity and phagocytosis; and complement-dependent cytotoxicity. Zymeworks is developing zanidatamab in multiple Phase 1, Phase 2, and pivotal clinical trials globally as a targeted treatment option for patients with solid tumors that express HER2. The FDA has granted Breakthrough Therapy designation for zanidatamab in patients with previously treated HER2 gene-amplified biliary tract cancer (BTC), and two Fast Track designations to zanidatamab, one as monotherapy for refractory BTC and one in combination with standard of care chemotherapy for first-line gastroesophageal adenocarcinoma (GEA). These designations mean zanidatamab is eligible for Accelerated Approval, Priority Review and Rolling Review, as well as intensive FDA guidance on an efficient drug development program. Zanidatamab has also received Orphan Drug designations from the FDA as well as the European Medicines Agency for the treatment of biliary tract and gastric cancers.

Sensei Biotherapeutics to Participate in the Piper Sandler 33rd Annual Healthcare Conference

On November 19, 2021 Sensei Biotherapeutics, Inc. (NASDAQ: SNSE), an immunotherapy company focused on the discovery and development of next generation therapeutics for cancer, reported its participation in a fireside chat during the Piper Sandler 33rd Annual Virtual Healthcare conference being held from November 29 to December 2, 2021 (Press release, Sensei Biotherapeutics, NOV 19, 2021, View Source [SID1234595843]).

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John Celebi, president and chief executive officer and Erin Colgan, senior vice president of finance and administration of Sensei Biotherapeutics, participated in a pre-recorded fireside chat. The webcast will be made available beginning 10:00 am ET on Monday, November 22, 2021, on the Events & Presentations section of Sensei’s website at www.senseibio.com. A replay of the webcast will be on the website for approximately 90 days following the event.

Xencor to Present at Upcoming Investor Conferences

On November 19, 2021 Xencor, Inc. (NASDAQ:XNCR), a clinical-stage biopharmaceutical company developing engineered monoclonal antibodies and cytokines for the treatment of cancer and autoimmune diseases, reported that company management will participate at two upcoming investor conferences (Press release, Xencor, NOV 19, 2021, View Source [SID1234595842]):

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Piper Sandler 33rd Annual Virtual Healthcare Conference
Presentation Available: Monday, November 22, 2021, 10:00 a.m. EST / 7:00 a.m. PST
Evercore ISI 4th Annual HealthconX Conference
Presentation Date: Wednesday, December 1, 2021, 1:00 p.m. EST / 10:00 a.m. PST
Webcasts of the presentations will be available under "Events & Presentations" in the Investors section of the Company’s website located at www.xencor.com. A replay of the live Evercore ISI presentation will be posted on the Xencor website approximately one hour after the live event. Both presentations will be available on the website for at least 30 days.

Oncolytics Biotech® to Present Phase 2 Triple-Negative Breast Cancer Trial Update at the 2021 San Antonio Breast Cancer Symposium

On November 19, 2021 Oncolytics Biotech Inc. (NASDAQ: ONCY) (TSX: ONC) reported that the Company will present an update on the Phase 2 IRENE trial in a poster at the 2021 San Antonio Breast Cancer Symposium (SABCS), which is taking place December 7 – 10, 2021, both virtually and in-person, at the Henry B. González Convention Center in San Antonio, Texas (Press release, Oncolytics Biotech, NOV 19, 2021, View Source [SID1234595841]).

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Details on the poster and its corresponding abstract, available on the SABCS website, are shown below.

Program Number: OT2-25-01
Title: IRENE study: Phase 2 study of INCMGA00012 and the oncolytic virus pelareorep in metastatic triple negative breast cancer
Session Name: Ongoing Trials Poster Session 2
Session Date: December 9, 2021
Session Time: 5:00 PM – 6:30 PM CT / 6:00 PM – 7:30 PM ET
Presenter: Dr. Mridula George

About IRENE
The IRENE (INCMGA00012 and the oncolytic virus pelareorep in metastatic triple-negative breast cancer) study is a single-arm, open-label, phase 2 study evaluating the combination of pelareorep and Incyte’s anti-PD-1 checkpoint inhibitor retifanlimab (INCMGA00012) for the treatment of unresectable locally advanced or metastatic triple-negative breast cancer. The study will enroll 25 patients and is being conducted at the Rutgers Cancer Institute of New Jersey and The Ohio State University Comprehensive Cancer Center.

Study participants will receive pelareorep intravenously on days 1, 2, 15, and 16 of 28-day treatment cycles. Retifanlimab will be administered on day 3 of each cycle, with treatment cycles continuing until disease progression is observed. The co-primary endpoints of the study are safety and objective response rate. Secondary endpoints include progression-free survival, overall survival, and duration of response. Exploratory endpoints include peripheral T cell clonality and pre- vs. post-treatment change in tumor PD-L1 expression.

For more information on the IRENE study, refer to View Source