ChemoCentryx to Present at the H.C. Wainwright Global Investment Conference

On May 16, 2022 ChemoCentryx, Inc., (Nasdaq: CCXI), reported that Thomas J. Schall, Ph.D., President and Chief Executive Officer, will present at the H.C. Wainwright Global Investment Conference on Tuesday, May 24, 2022 at 12:30 p.m. ET (Press release, ChemoCentryx, MAY 16, 2022, https://ir.chemocentryx.com/news-releases/news-release-details/chemocentryx-present-hc-wainwright-global-investment-conference [SID1234614671]). The conference will be held at the Fontainebleau Miami Beach Hotel in Miami, FL.

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!

A live audio webcast of the presentations can be accessed through the Investors section of the Company’s website at www.ChemoCentryx.com. A replay of the webcast will be available on the Company’s website for two weeks following the live presentation.

VYANT BIO REPORTS FIRST QUARTER 2022 RESULTS AND PROVIDES STRATEGIC AND BUSINESS HIGHLIGHTS

On May 16, 2022 Vyant Bio, Inc. ("Vyant Bio", "Company") (Nasdaq: VYNT) is an innovative biotechnology company reinventing drug discovery for complex neurodevelopmental and neurodegenerative disorders (Press release, Vyant Bio, MAY 16, 2022, View Source [SID1234614670]). The Company’s central nervous system ("CNS") drug discovery platform combines human-derived organoid models of brain disease, scaled biology, and machine learning. Today, Vyant Bio expects to file its Form 10-Q for the First Quarter 2022 with the Securities and Exchange Commission and will report its First Quarter 2022 highlights and business updates this afternoon in a conference call and webcast scheduled for 4:30 pm ET.

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!

"During the first quarter of 2022, we progressed our scientific work by using our proprietary drug discovery platform centered on human iPSC-derived neurospheroids to unveil novel targets and potentially disease-modifying therapeutics to treat patients suffering from severe neurodevelopmental and neurodegenerative diseases. We are validating important data that we believe will demonstrate our ability to de-risk the selection of therapeutics that can rescue a disease phenotype. We believe current preclinical models are not sufficiently predictive, and many current therapies for CNS disorders only address the symptoms and do not reverse the effects of neurological diseases. Our focus during the first 90 days of 2022 was to progress our platform validation efforts to advance our CNS programs that are designed to identify disease-modifying therapeutics, consistent with our plans and prior disclosures to our shareholders," stated Jay Roberts, the Company’s Chief Executive Officer.

"As we highlighted in our last earnings conference call, we believe our focus on complex neurodevelopmental and neurodegenerative disorders addresses significant unmet medical needs, and will lead to the identification of important, disease modifying therapies for major causes of death and disability worldwide. Our Rett patient-derived neural spheroids show a robust and reproducible disease-specific phenotype that can be quantified in an unbiased manner across dozens of endpoints. By phenotypic screening of our Rett neural spheroids, we identified VYNT-0126 which has consistently shown a dose-dependent unique rescue of the RTT functional phenotype with a differentiated mechanism of action from other Rett syndrome clinical candidates. Our ongoing work on CDKL5 and familial Parkinson’s disease has further established that our discovery platforms represent a new, unique robust model for human-first CNS drug discovery" stated Dr. Robert Fremeau, Chief Scientific Officer of Vyant Bio.

FIRST QUARTER 2022 FINANCIAL RESULTS

Cash and cash equivalents totaled $16.4 million as of March 31, 2022. The Company implemented two new vehicles to facilitate the raising of additional equity capital at the Company’s option with the finalization of the Lincoln Park Equity line of credit allowing access to raise up to $15 million, as well as signing a $14.5 million ATM with Canaccord Genuity. The Company’s current cash balances, future proceeds from the sale of vivoPharm and future proceeds from the equity line of credit and ATM are expected to fund operations well into 2023.

During the first quarter of 2022, the Company continued the process of divesting the vivoPharm business which is expected to complete in 2022. Therefore, the vivoPharm business is classified as a "held-for-sale" asset, and its financial information as "discontinuing operations".

The Company’s loss from continuing operations aggregated $4.4 million in the first quarter of 2022 and included non-cash depreciation and amortization as well as stock-based compensation expenses of $98 thousand and $278 thousand, respectively, and one-time severance charges of $437 thousand. Discontinuing operations net loss for the March 31, 2022 quarter aggregated $4.8 million and included a non-cash impairment charge of $4.3 million resulting from changed market conditions for contract research organizations from December 31, 2021 to March 31, 2022.

Total revenue from continuing operations increased 49.3%, or $100 thousand, to $303 thousand for the three months ended March 31, 2022, as compared with $222 thousand for the three months ended March 31, 2021.

Cost of goods sold – service from continuing operations totaled $38 thousand and $64 thousand, respectively, for the three months ended March 31, 2022 and 2021, resulting in a cost of goods sold of 40% and 66%, respectively, of service revenue.

Cost of goods sold – product costs decreased by 12%, or $48 thousand to $348 thousand for the three months ended March 31, 2022, as compared with $396 thousand for the three months ended March 31, 2021.

Research and development expenses increased by 89%, or $731 thousand, to $1.6 million for the three months ended March 31, 2022 from $820 thousand for the three months ended March 31, 2021. This increase is principally due a $336 thousand increase in payroll-related and consulting expenses, a $315 thousand increase in research and development activities at our Maple Grove facility, and $48 thousand related to moving to a new facility in California.

Selling, general and administrative expenses increased by 128%, or $1.5 million, to $2.8 million for the three months ended March 31, 2022, as compared with $1.2 million for the three months ended March 31, 2021. The 2021 period reflects the Company as a privately-held company whereas the 2022 period reflect the Company as a publicly-held company. The quarter ended March 31, 2022 includes incremental $564 thousand of payroll-related expenses, including one-time contractual severance benefits for two former employees of $437 thousand. The Company incurred incremental professional services fees of $472 thousand in the first quarter of 2022 as compared with the same prior-year period related to accounting, audit and other professional services and incurred $418 thousand of additional insurance expense.

Vyant Bio’s Conference Call and Webcast and Information

Vyant Bio’s management will host a conference call on Monday, May 16, 2022 at 4:30pm ET to discuss the first quarter 2022 results and provide strategic business updates as well as answer questions. Event information is below:

The live event will be recorded and available for replay. The conference call and webcast details are also included inside the Investors section of the Vyant Bio corporate website at www.vyantbio.com.

TRACON Pharmaceuticals To Present At The H.C. Wainwright Global Investment Conference

On May 16, 2022 TRACON Pharmaceuticals (Nasdaq: TCON), a clinical stage biopharmaceutical company focused on the development and commercialization of novel targeted cancer therapeutics and utilizing a cost efficient, CRO-independent product development platform to partner with life science companies through a profit-share, revenue share, or franchise model, reported that Charles Theuer, M.D., Ph.D., President and Chief Executive Officer, will present a corporate overview at the H.C. Wainwright Global Investment Conference, being held May 23-26, 2022 (Press release, Tracon Pharmaceuticals, MAY 16, 2022, View Source [SID1234614669]).

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 presentation will be available on-demand beginning at 7:00 AM Eastern Time on Tuesday, May 23, 2022, in the Investors section on the Company’s website at www.traconpharma.com.

Neoleukin Therapeutics Announces First Patient Treated in Combination Arm of Phase 1 Trial Evaluating NL-201 in Combination with KEYTRUDA® (pembrolizumab)

On May 16, 2022 Neoleukin Therapeutics, Inc., "Neoleukin" (NASDAQ:NLTX), a biopharmaceutical company utilizing sophisticated computational methods to design de novo protein therapeutics, reported treatment of the first patient in a combination arm evaluating the safety and efficacy of Neoleukin’s NL-201 in combination with Merck’s anti-PD-1 therapy KEYTRUDA (pembrolizumab), as part of Neoleukin’s ongoing Phase 1 trial in patients with relapsed or refractory solid tumors (Press release, Neoleukin Therapeutics, MAY 16, 2022, View Source [SID1234614668]).

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!

"We are pleased to begin the combination arm of our NL-201 trial and evaluate the potential to combine these two agents, which demonstrated encouraging preclinical anti-tumor activity in multiple tumor models," said Priti Patel, MD, Chief Medical Officer at Neoleukin. "Based on the preclinical information, we believe that adding NL-201 to pembrolizumab has the potential to provide increased benefits to patients, and we are excited to learn more through this part of the study."

Up to 132 patients will be enrolled in the combination arm of the study, which is being conducted through a clinical collaboration and supply agreement with Merck (known as MSD outside the United States and Canada). The trial is assessing safety, pharmacokinetics, pharmacodynamics, immunogenicity, and antitumor activity.

KEYTRUDA is a registered trademark of Merck Sharp & Dohme LLC, a subsidiary of Merck & Co., Inc., Rahway, NJ, USA.

About NL-201
NL-201 is a de novo agonist of the IL-2 and IL-15 receptors, designed to expand cancer-fighting CD8 T cells and natural killer (NK) cells without any bias toward cells expressing the alpha receptor subunit (CD25). Previously presented preclinical data has demonstrated the ability of NL-201 to stimulate and expand CD8+ and NK cells at low doses with minimal impact on immunosuppressive regulatory T cells. Furthermore, NL-201 has demonstrated both monotherapy and combination activity across a wide range of preclinical syngeneic tumor models.

AFFIMED PRESENTS DATA ON INNATE CELL ENGAGERS AFM24 AND AFM28 AT 19TH MEETING OF THE SOCIETY FOR NATURAL IMMUNITY

On May 16, 2022 Affimed N.V. (Nasdaq: AFMD) ("Affimed", or the "Company"), a clinical-stage immuno-oncology company committed to giving patients back their innate ability to fight cancer, reported the presentation of new data on AFM24 and AFM28 in two posters at the 19th Meeting of the Society for Natural Immunity (NK2022) (Press release, Affimed, MAY 16, 2022, View Source [SID1234614667]).

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 AFM24 presentation showed correlative science data of the exposure and pharmacodynamic effects of the compound in patients with epidermal growth factor receptor (EGFR)-expressing solid tumors from the ongoing phase 1/2a study. The poster featured an analysis of the longitudinal effects of AFM24, a CD16A/EGFR‑targeting bispecific innate cell engager (ICE), in patients treated in the AFM24-101 phase 1/2a clinical study, confirming the mechanism of action of AFM24 on the innate immune system.

The correlative science data further supports the rationale for combining different therapeutic approaches in patients with EGFR-expressing solid tumors. AFM24 engages CD16A on natural killer (NK) cells and macrophages with higher affinity than monoclonal antibodies, and triggers antibody-dependent cellular cytotoxicity (ADCC) and antibody-dependent cellular phagocytosis (ADCP), respectively, directed at EGFR-expressing cancer cells. Preclinical data have shown that AFM24 can induce NK cell-mediated killing of EGFR-positive solid tumor cell lines, independent of EGFR mutational status.

The analysis also showed activation of cytotoxic T cells in the periphery, and infiltration of T cells into the tumor bed, suggesting stimulation of anti-cancer immunity beyond the innate immune system and the possible engagement of the adaptive immune system. These data support the rationale for AFM24 as monotherapy and the two combinations that are currently under way in separate phase 1/2a studies – with autologous NK cell therapy and with immune checkpoint inhibition.

The AFM28 poster featured preclinical data on the anti-leukemic activity of the compound when pre-complexed and co-administered with allogeneic NK cells.

AFM28 is a novel ICE binding to CD16A on NK cells, and CD123 on acute myeloid leukemia (AML) and myelodysplastic syndrome (MDS) tumor cells. The novel bispecific engager binds with high affinity to NK cells stimulating them to destroy CD123-positive tumor cells via ADCC. In addition, AFM28 exhibits greater cell surface retention than conventional monoclonal antibodies, including Fc-enhanced IgG1.

Furthermore, the data presented at the conference demonstrate that AFM28 stimulates lysis of CD123-positive tumor cells in both formats, pre-complexed or when co-administered with NK cells. The poster also demonstrated the feasibility of cryopreserving AFM28 pre-complexed with NK cells whilst maintaining anti-tumor activity suggesting the promise for an off-the-shelf therapy targeting leukemic blasts and leukemic stem cells in patients with AML and MDS.

Poster details:
Title: Analysis of the Longitudinal Effects of AFM24, a CD16A/Epidermal Growth Factor Receptor Targeting (EGFR) Bispecific Innate Cell Engager, Confirms the Mechanism of Action and Supports the Rationale for Combination Approaches in Patients with EGFR-Expressing Solid Tumors
Authors: Gabriele Hintzen, Susanne Wingert, Michael Emig, Kerstin Pietzko, Uwe Reusch, Melissa M. Berrien‐Elliott, Todd A. Fehniger, Mark Foster, Paolo Nuciforo, Tyler Burns, Paulien Ravenstijn, Stefan Knackmuss, Bettina Rehbein, Joachim Koch, Arndt Schottelius, and Erich Rajkovic

Title: Novel Bispecific Innate Cell Engager AFM28 in Combination with Allogeneic NK Cells for the Treatment of CD123+ Acute Myeloid Leukemia and Myelodysplastic Syndrome
Authors: Jens Pahl, Jana-Julia Siegler, Armin Beez, Rebecca Hussong, Sabrina Purr, Lena Wagner, Nicole Schulze, Tatjana Kosbar, Uwe Reusch, Joachim Koch, Arndt Schottelius, Thorsten Ross, Christian Merz and Sheena Pinto

About AFM24
AFM24 is a tetravalent, bispecific innate cell engager (ICE) that activates the innate immune system by binding to CD16A on innate immune cells and EGFR, a protein widely expressed on solid tumors, to kill cancer cells. Generated by Affimed’s fit-for-purpose ROCK platform, AFM24 represents a distinctive mechanism of action that uses EGFR as a docking site to engage innate immune cells for tumor cell killing through antibody-dependent cellular cytotoxicity and antibody-dependent cellular phagocytosis.
Affimed is evaluating AFM24 in patients with advanced EGFR-expressing solid malignancies whose disease has progressed after treatment with previous anticancer therapies as monotherapy and in combinations with other cancer treatments. AFM24-101, a monotherapy, first-in-human phase 1/2a open-label, is a non-randomized, multi-center, multiple ascending dose escalation and expansion study. Additional details may be found at www.clinicaltrials.gov using the identifier NCT04259450. Furthermore, AFM24 is being evaluated in a phase 1/2a study in combination with Roche’s anti-PD-L1 checkpoint inhibitor atezolizumab (AFM24-102, NCT05109442). Affimed and NKGen Biotech have initiated a phase 1/2a study (AFM24-103), investigating AFM24 in combination with SNK01, NKGen Biotech’s NK cell product (NCT05099549).

About AFM28
AFM28 is a tetravalent, bispecific innate cell engager (ICE) that activates the innate immune system by binding to CD16A on innate immune cells and CD123-positive cells on myeloid malignancies. Developed on Affimed’s ROCK platform, it is designed to bring a new immunotherapeutic approach to patients with CD123-positive myeloid malignancies, including acute myeloid leukemia and myelodysplastic syndrome (MDS). AFM28 engages NK cells to initiate tumor cell killing via antibody-dependent cellular cytotoxicity (ADCC), and binds CD123-positive cancer cells even at low expression levels. Clinical development is planned as both monotherapy and in combination with allogeneic NK cells in patients with relapsed/refractory CD123-positive leukemias.