Correction Notice to Press Release Announcing Financial Results For the Fourth Quarter and Full Year 2021 Financial Results and Corporate Update

On May 18 , 2022 Allarity Therapeutics, Inc. (NASDAQ: ALLR) reported that its press release issued under the headline "Allarity Therapeutics Reports Fourth Quarter and Full Year 2021 Financial Results and Provides a Corporate Update" on May 16, 2022, included a typographical error in the section titled "Full Year 2021 and Recent Highlights", describing the size of the debt cancellation which should have read "$971 thousand" instead of "$971 million (Press release, Allarity Therapeutics, MAY 18, 2022, View Source [SID1234614870])." The corrected paragraph is set forth below:

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Full Year 2021 and Recent Highlights

In March 2022, entered into two agreements amending the LiPlaCis program. As a result of this amendment, Allarity will be exempt from any future financial obligation associated with the further development of LiPlaCis, including the cancellation of outstanding liability of $971 thousand. Allarity will also maintain its ability to receive possible future milestone payments of up to $3.5 million

Bicara Therapeutics to Present Clinical Data from Lead Bifunctional Antibody Program, BCA101, at ASCO 2022 Annual Meeting

On May 18, 2022 Bicara Therapeutics, a clinical-stage biotechnology company developing dual-action biologics designed to elicit a potent and durable immune response in the tumor microenvironment, reported that it will present updated data from the dose escalation phase of its ongoing Phase 1 trial of BCA101, a bifunctional antibody designed to target the TGF-β trap to EGFR+ tumors, in an oral presentation at the upcoming American Society of Clinical Oncology (ASCO) (Free ASCO Whitepaper) 2022 Annual Meeting (Press release, Bicara Therapeutics, MAY 18, 2022, View Source;utm_medium=rss&utm_campaign=bicara-therapeutics-to-present-clinical-data-from-lead-bifunctional-antibody-program-bca101-at-asco-2022-annual-meeting [SID1234614785]). The meeting is being held in Chicago, Illinois and virtually from June 3-7, 2022.

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Details of the presentation are as follows:

Title: A phase 1 trial of the bifunctional EGFR/TGFb fusion protein BCA101 alone and in combination with pembrolizumab in patients with advanced solid tumors

Lead Authors: Philippe L. Bedard, MD, FRCPC & Glenn J. Hanna, MD

Presentation Type: Poster Discussion Session
Session Category: Developmental Therapeutics – Immunotherapy
Date/Time: Sunday, June 5, 2022, 11:30 AM-1:00 PM CDT

Location: Hall D2

About BCA101

BCA101 is a first-in-class EGFR / TGF-β-trap bifunctional antibody designed to enhance both innate and adaptive immune responses directly at the site of the tumor by binding to the well-validated EGFR antigen and disabling TGF-β, a signaling molecule that plays a key role in suppressing the immune response in the tumor microenvironment. Promising preclinical data suggest that BCA101 is superior to the anti-EGFR antibody cetuximab in preventing tumor recurrence, as well as in restoring immune activation. An ongoing Phase 1/1b dose-escalation clinical trial of BCA101 was initiated in July 2020 and has enrolled patients with various advanced solid tumors both as a single agent, as well as in combination with pembrolizumab, a PD-1 inhibitor. A recommended dose for expansion has been declared and the expansion phase of the study is currently enrolling. For more information, please visit study number NCT04429542 at www.clinicaltrials.gov.

Kineta Presenting in Multiple Sessions at the Preclinical Immuno-oncology Online 2022

On May 18, 2022 Kineta, Inc., a clinical stage biotechnology company focused on the development of novel immunotherapies in oncology, reported its participation at Preclinical Immuno-oncology Online 2022 (Press release, Kineta, MAY 18, 2022, View Source;utm_medium=rss&utm_campaign=kineta-presenting-in-multiple-sessions-at-the-preclinical-immuno-oncology-online-2022 [SID1234614802]). Thierry Guillaudeux, PhD, EVP Research and Development at Kineta, will make a presentation on "Human Knock-In Mice For Selecting Next Generation Immune Checkpoint Inhibitors" and participate in a panel discussion on "The Future of In Vivo Models" at the virtual symposium to be held on May 18, 2022.

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As part of his presentation, Dr Guillaudeux will discuss key technology and advantages of Kineta’s proprietary PiiONEER platform. The company’s immuno-oncology platform was designed for the discovery and development of first or best-in-class immunotherapies that address the major challenges with cancer resistance to current therapies. Kineta has developed novel, innate immuno-oncology antibody therapeutics targeting VISTA and CD27.

"I am thrilled to participate in this symposium and discuss Kineta’s immuno-oncology focused PiiONEER platform", said Dr. Guillaudeux. "Kineta’s specialized in vivo preclinical models are used to characterize a therapeutic antibody’s anti-cancer efficacy, pharmacokinetics, receptor occupancy and biomarkers and are key development technologies in our innovative platform"

Kineta has developed monoclonal antibody programs targeting VISTA and CD27 through the PiiONEER platform. KVA12.1 is a potential best-in-class VISTA blocking immunotherapy. It is a fully human engineered IgG1 monoclonal antibody that was designed to bind to VISTA through a unique epitope. In preclinical models, KVA12.1 demonstrates strong single agent efficacy in cold tumors and complementary efficacy when dosed in combination with other checkpoint inhibitors (CPI’s). It is well-tolerated with no change IL6 and TNFα levels responsible for cytokine release syndrome (CRS) in preclinical toxicology studies. KVA12.1 is being developed as an intravenous infusion for patients with advanced solid tumors. Kineta plans to initiate Phase 1 clinical studies in Q4 2022. Kineta is also developing an anti-CD27 agonist monoclonal antibody for patients with solid and hematologic tumors. Kineta is in the final stage of lead selection and plans to nominate a clinical candidate in Q2 2022.

Preclinical Immuno-oncology Online 2022 is a virtual conference that assembles a wide range of senior leaders from leading healthcare, biotech, pharma and research institutions. The conference delves into the challenges and opportunities in innovative approaches to preclinical drug development with a goal to achieve translational success.

Fortress Biotech to Participate in Two Upcoming May 2022 Investor Conferences

On May 18, 2022 Fortress Biotech, Inc. (NASDAQ: FBIO) ("Fortress"), an innovative biopharmaceutical company focused on efficiently acquiring, developing and commercializing or monetizing promising therapeutic products and product candidates, reported that Lindsay A. Rosenwald, M.D., Chairman, President and Chief Executive Officer, will participate in two investor conferences in May 2022 (Press release, Fortress Biotech, MAY 18, 2022, View Source [SID1234614818]).

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Details of the events are as follows:

H.C. Wainwright Global Investment Conference: The company will present on Tuesday, May 24, 2022, at 9:30 a.m. ET and will participate in one-on-one meetings during the conference. A webcast of the presentation will be available on the Events page under the News & Media section of Fortress’ website: www.fortressbiotech.com for approximately 30 days following the meeting.
B. Riley Securities 22nd Annual Institutional Investor Conference: The company will participate in a fireside chat on Thursday, May 26, 2022, at 10:10 a.m. PT and will participate in one-on-one meetings during the conference.

Cytovia Therapeutics to Present In Vivo Multiple Myeloma Data of its CD38-Targeting Flex-NK™ Cell Engager at EHA 2022 Congress

On May 18, 2022 Cytovia Therapeutics, LLC ("Cytovia Therapeutics"), a global biotechnology company focused on harnessing the power of natural killer (NK) cells to fight cancer through multispecific antibodies and stem cell engineering, reported that it will be presenting at the the Annual European Hematology Association (EHA) (Free EHA Whitepaper)’s (EHA) (Free EHA Whitepaper) 2022 Hybrid Congress, taking place June 9 – 12, 2022 at the Messe Wien Exhibition and Congress Center in Vienna, Austria, and online (Press release, Cytovia Therapeutics, MAY 18, 2022, View Source [SID1234614834]).

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The abstract was released on May 12, 2022. The e-poster presentation will be published on the virtual congress platform on Friday, June 10.

Details of Cytovia’s poster presentation:
Title: NOVEL MULTIFUNCTIONAL TETRAVALENT CD38 NKP46 FLEX-NK ENGAGERS ACTIVELY TARGET AND KILL MULTIPLE MYELOMA CELLS
Session Title: Poster session
Session date and time: Friday, June 10, 2022 – 16:30 – 17:45 CEST
Final Abstract Code: P842
Presenting Author: Jean Christophe Bories
Summary: CYT-338 is a tetravalent IgG1-like multifunctional NK cell engager antibody with a novel FLEX-linker that simultaneously binds CD38-expressing cells and NK cells via the activation receptor NKp46. The in vitro and in vivo activity of CYT-338 was studied in myeloma models. CYT-338 showed specific dose-dependent binding to CD38 expressing MM cells with ~ 2-fold higher mean fluorescence intensity than daratumumab. Epitope mapping studies suggest binding of CYT-338 to a CD38 epitope distinct from daratumumab. CYT-338 showed greater dose dependent NK cell redirected cytolysis, degranulation, and cytokine production against MM1S cells compared to daratumumab. CYT-338 combined with peripheral blood NK cells inhibited tumor growth in a MM1S-NSG mouse model. CYT-338 showed minimal immune subset depletion, NK cell fratricide, and cytokine release compared to daratumumab in human PBMCs in-vitro. These results suggest that the CYT-338 engager has a favorable NK cell engager profile for targeting CD38-expressing multiple myeloma distinct from daratumumab.