On November 9, 2021 Eli Lilly and Company (NYSE: LLY) reported that it will participate in the Wolfe Research Virtual Healthcare Conference on Thursday, Nov. 18, 2021 (Press release, Eli Lilly, NOV 9, 2021, View Source [SID1234594890]). Jacob Van Naarden, CEO of Loxo Oncology at Lilly and president, Lilly Oncology; Mark Mintun, senior vice president, research and development – neuroscience, and president, Avid Radiopharmaceuticals; and David Hyman, M.D., chief medical officer, Lilly Oncology, will participate in a fireside chat at 10:30 a.m., Eastern time .

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A live audio webcast will be available on the "Webcasts & Presentations" section of Lilly’s Investor website at View Source A replay of the presentation will be available on this same website for approximately 90 days.

On November 9, 2021 Avalo Therapeutics, Inc. (Nasdaq: AVTX), a leading clinical-stage precision medicine company that discovers, develops, and commercializes targeted therapeutics for patients with significant unmet clinical need in immunology, immuno-oncology, and rare genetic diseases reported that business updates and third quarter 2021 financial results (Press release, Avalo Therapeutics, NOV 9, 2021, View Source [SID1234594906]).

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"The third quarter was focused on execution ahead of a number of data readouts in multiple key pipeline programs anticipated in the coming months," said Mike Cola, Chief Executive Officer of Avalo Therapeutics. "We further solidified our balance sheet with a successful public offering in September that puts the Company in a position to support the development of our pipeline through multiple catalysts."

Business Updates:

In July 2021, the Company reported positive initial results for the low-dose cohort (1.0 mg/kg) of its Phase 1b proof-of-concept study of AVTX-002, an investigational first-in-class fully human anti-LIGHT (tumor necrosis factor superfamily member 14 (TNFSF14)) monoclonal antibody (mAb), in adult patients with moderate to severe Crohn’s disease.
Completed rebranding to Avalo Therapeutics, Inc. from Cerecor Inc., accentuating the Company’s transition to developing innovative targeted therapies in immunology, immuno-oncology, and rare genetic diseases.
In September 2021, the Company raised gross proceeds of approximately $31.5 million through a public offering of common stock, which strengthens and extends the Company’s financial resources to advance its clinical pipeline towards key development milestones. Avalo had cash and cash equivalents of $71.5 million as of September 30, 2021.
During the third quarter of 2021, the Company completed its second drawdown of $10 million and third drawdown of $5 million under its previously announced $35 million venture debt financing agreement with Horizon Technology Finance Corporation. With the closing of the second and third tranches, the Company has received the full $35 million of gross proceeds under its debt financing agreement.
Program Updates and Milestones:

AVTX-002: Anti-LIGHT mAb targeting immune-inflammatory diseases including acute respiratory distress syndrome (ARDS) and moderate-to-severe inflammatory bowel disease (Crohn’s disease and ulcerative colitis).
The Company has completed enrollment in Cohort 2 (3.0 mg/kg) of its Phase 1b proof-of-concept trial of AVTX-002 in moderate-to-severe Crohn’s disease and anticipates top-line data in the fourth quarter of 2021.
Based on the positive data from Cohort 1 (1.0 mg/kg) of its Phase 1b trial of AVTX-002 in moderate-to-severe Crohn’s disease, the Company has expanded the IBD program to include patients with moderate-to-severe ulcerative colitis who are refractory to anti-TNF alpha therapies.
The Company remains in dialogue with the FDA and is working through feedback to determine the trial design for a registrational study of AVTX-002 in COVID-19 ARDS and accompanying timelines, including the potential expansion to a larger patient population in broader ARDS.
AVTX-007: Anti-IL-18 mAb targeting immuno-oncology and immune-inflammatory diseases including multiple myeloma (MM) and adult onset Still’s disease (AOSD).
The Company anticipates top-line data from the Phase 1b clinical trial in relapsed or refractory MM patients in the fourth quarter of 2021.
The Company anticipates initial data from the Phase 1b clinical trial in AOSD patients in the first quarter of 2022.

AVTX-006: Dual mTORc1/c2 small molecule inhibitor for complex lymphatic malformations.
The Company anticipates initial data from the Phase 1b proof-of-concept clinical trial in the first quarter of 2022.
AVTX-800 programs (AVTX-801, AVTX-802, and AVTX-803): Therapeutic doses of monosaccharide therapies for congenital disorders of glycosylation (CDGs).
AVTX-801 – In collaboration with the Frontiers in Congenital Disorders of Glycosylation Consortium clinical program, data from the pivotal trial evaluating the safety and efficacy of D-galactose in Phosphoglucomutase-1 deficiency related CDG (PGM1-CDG) patients are anticipated in 2022.
AVTX-802 – Data from the pivotal trial evaluating the safety and efficacy of D-mannose in Mannose phosphate isomerase deficiency related CDG (MPI-CDG) patients are anticipated in 2022.
AVTX-803 – Data from the pivotal trial evaluating the safety and efficacy of L-fucose in Leukocyte Adhesion Deficiency II (LAD II) patients are anticipated in the first half of 2022.
Third Quarter 2021 Financial Update:

As of September 30, 2021, Avalo had $71.5 million in cash and cash equivalents, representing a $52.6 million increase as compared to December 31, 2020. The increase was primarily driven by gross proceeds of $31.5 million from an underwritten public offering completed in September 2021, $35 million from a debt financing agreement entered into in June 2021 ($20 million funded in the second quarter and remaining $15 million funded in the third quarter), and gross proceeds of $40.7 million from an underwritten public offering completed in January 2021. Such increases were partially offset by operating expenditures, the majority of which related to pipeline development.

Net product revenue of the Company’s non-core commercialized product was $1.4 million for the three months ended September 30, 2021, which was largely consistent with the net product revenue for the three months ended September 30, 2020 of $1.1 million.

Total operating expenses increased $3.4 million for the three months ended September 30, 2021 as compared to the three months ended September 30, 2020, which was the largest driver of the increase in net loss period over period. The increased operating expenses were largely driven by a $1.7 million increase in research and development expenses due to Avalo’s continued advancement of its maturing pipeline.

Condensed Consolidated Balance Sheets

(a) The unaudited condensed consolidated statements of operations for the three and nine months ended September 30, 2021 and 2020 have been derived from the reviewed financial statements but do not include all of the information and footnotes required by accounting principles generally accepted in the United States for complete financial statements.

On November 9, 2021 Nektar Therapeutics (NASDAQ:NKTR) reported that it will host a webcast analyst and investor conference call with a cancer specialist and Nektar management on Friday, November 12, 2021, at 12:00 p.m. EST during the 2021 Society for Immunotherapy of Cancer (SITC) (Free SITC Whitepaper) Annual Meeting (Press release, Nektar Therapeutics, NOV 9, 2021, https://www.prnewswire.com/news-releases/nektar-therapeutics-to-host-webcast-conference-call-for-analysts–investors-with-cancer-specialist-during-2021-society-for-immunotherapy-of-cancer-sitc-36th-annual-meeting-301419303.html [SID1234594922]). The call will be hosted by Nektar management and will include, SITC (Free SITC Whitepaper) author and presenter, Dr. Mehmet Altan, Assistant Professor, Department of Thoracic/Head and Neck Medical Oncology, Division of Cancer Medicine at The University of Texas Anderson Cancer Center and Dr. Alan Tan, Director of GU Medical Oncology and Assistant Professor in the Division of Hematology, Oncology and Cell Therapy at Rush University Medical Center.

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The event will follow the publication of the NKTR-255 poster (Abstract #957) on Friday morning. SITC (Free SITC Whitepaper) is being held in Washington, D.C. and virtually from November 10 to November 14, 2021.

Analyst Call:

Date and Time: Friday, November 12, 2021, at 12:00 p.m. EST

Dial-in: 877-881-2183 (toll-free) or 970-315-0453 (enter access code 1769208)

Investors and analysts can also view slides and listen to the live audio webcast of the presentation at View Source The event will also be available for replay for two weeks on Nektar’s website: www.nektar.com.

Details of the presentations at SITC (Free SITC Whitepaper) are as follows:

Nektar Poster Presentations at SITC (Free SITC Whitepaper)

Abstract 957: "NKTR-255 Plus Cetuximab in Patients with Solid Tumors: Interim Safety and Efficacy Results from the Phase 1b Dose Escalation Study," Altan, M., et al.

Presenter: Dr. Mehmet Altan, MD Anderson Cancer Center
ePoster and live poster will be available on Friday, November 12th, 2021, at 7:00 a.m. EST
Poster reception: Friday, November 12, 2021, from 7:00 p.m. – 8:30 p.m. EST
Additional Collaborator Presentations at SITC (Free SITC Whitepaper)

Abstract 59: "Associations between KIR/KIR-ligand genotypes and clinical outcome for patients with advanced solid tumors receiving BEMPEG plus nivolumab combination therapy in the PIVOT-02 trial," Feils, AS., et al.

ePoster will be on display on the SITC (Free SITC Whitepaper) 2021 virtual meeting platform on Friday, November 12, 2021, at 7:00 a.m. EST
Abstract 596: "Combining Bempegaldesleukin (CD122-preferential IL-2 pathway agonist) and NKTR-262 (TLR7/8 agonist) pairs local innate activation with systemic CD8+ T cell expansion to enhance anti-tumor immunity," Rolig, A., et al.

ePoster will be on display on the SITC (Free SITC Whitepaper) 2021 virtual meeting platform on Friday, November 12, 2021, at 7:00 a.m. EST
Dr. Mehmet Altan

Mehmet Altan, MD, is an Assistant Professor in the Department of Thoracic/Head and Neck Medical Oncology, Division of Cancer Medicine at The University of Texas Anderson Cancer Center. Dr. Altan is one of the lead investigators in the phase 1/2, dose-escalation and dose-expansion study of NKTR-255 in combination with cetuximab in patients with refractory 2nd and 3rd line metastatic colorectal cancer or metastatic head and neck cancer. His current research areas include identification of mechanisms for primary and secondary resistance to immunotherapies and predictive markers for immunotherapy toxicities. He also works on translational research projects for identification of spatiotemporal dynamics of the tumor microenvironment in response to immunotherapy to define potential therapeutic targets.

Dr. Alan Tan

Alan Tan, MD, is a Director of GU Medical Oncology and an Assistant Professor in the Division of Hematology, Oncology and Cell Therapy at Rush University Medical Center. He specializes in kidney cancer, urothelial/bladder cancer, prostate cancer and melanoma. Dr. Tan has clinical research interest in designing and implementing clinical trials to test novel immunotherapies and targeted therapies in these cancers. He also leads the Rush University Precision Oncology and Genomics program. He is co-chair for the Hoosier Cancer Research Network (HCRN) Melanoma Working Group.

On November 9, 2021 Australian clinical-stage drug development company Noxopharm (ASX:NOX) reported its DARRT-2 Phase 2 clinical trial has commenced with patient enrollment in the U.S (Press release, Noxopharm, NOV 9, 2021, View Source [SID1234594938]).

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DARRT (Direct and Abscopal Response to Radiotherapy) is an experimental immunotherapy cancer treatment based on the concept of Veyonda combining with a well-tolerated, low dosage of external beam radiotherapy to trigger an immune response — known as an abscopal response — which may lead to the resolution of tumors.

DARRT treatment has the potential to revolutionize cancer treatment by achieving cancer reduction without many of the unwanted side effects, cost limitations, and logistical challenges associated with other immunotherapies.

Since low dose radiotherapy is a common form of cancer therapy, the therapeutic and commercial opportunities of adding Veyonda to transform symptomatic relief into a meaningful tumor response are substantial. Noxopharm is confident of securing the value of this opportunity by patents, starting with the allowance of claims by the U.S. Patent Office.

The inaugural sites are the Beverly Hills Cancer Center and the MD Anderson Cancer Center, with remaining sites in North America, Europe, and Australia.

Noxopharm Chief Medical Officer, Dr. Gisela Mautner, said, "The participation of institutions with prestigious radiation and medical oncologists is testament to the potential of the DARRT-treatment."

On November 9, 2021 Zymeworks Inc. (NYSE: ZYME), a clinical-stage biopharmaceutical company developing multifunctional biotherapeutics, reported that Neil Josephson, M.D., who has been serving as the company’s interim Chief Medical Officer (CMO) since May of this year, will transition to the permanent CMO position, effective November 15 (Press release, Zymeworks, NOV 9, 2021, View Source [SID1234594954]).

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"Over the past six months, Neil has done an exemplary job of leading Zymeworks’ Medical organization and the advancement of our clinical pipeline," said Ali Tehrani, Ph.D., Zymeworks’ President and CEO. "I am very pleased that Neil will be at the helm as we enroll our second pivotal trial for zanidatamab in HER2-positive gastroesophageal adenocarcinomas and continue to expand the development of zanidatamab and ZW49 in additional indications, including breast cancer."

Dr. Josephson joined Zymeworks in 2019 as Vice President, Clinical Research and was promoted to Senior Vice President, Clinical Research last year, before his May appointment to interim CMO. Prior to joining Zymeworks, Dr. Josephson spent nearly six years at Seagen Inc., most recently as Vice President of Clinical Development, where he worked on multiple early and late-stage programs, including leading the approval of ADCETRIS for the 1st line treatment of advanced Hodgkin’s lymphoma. Before joining Seagen, he was an Associate Professor of Medicine in the Division of Hematology at the University of Washington. He received an M.D. degree from Columbia University and an A.B. from Dartmouth College.