On August 4, 2022 NextCure, Inc. (Nasdaq: NXTC), a clinical-stage biopharmaceutical company committed to discovering and developing novel, first-in-class immunomedicines to treat cancer and other immune-related diseases, reported second quarter 2022 financial results and provided a business update (Press release, NextCure, AUG 4, 2022, View Source [SID1234617546]).

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"We have set the stage for multiple clinical data updates in the second half of this year for our NC318, NC410, and NC762 programs as well as an IND filing for NC525," said Michael Richman, NextCure’s president and chief executive officer. "We expect our strong cash position of $185.5 million as of June 30, 2022 will fund our operations into the first quarter of 2024."

Business Highlights

NC318

Announced the publication of a paper titled "Development of an Immunohistochemical Assay for Siglec-15" in Laboratory Investigation. The publication outlines data from a study, conducted in collaboration with researchers in the Department of Pathology at Yale School of Medicine, utilizing a newly developed antibody to Siglec-15 (S15) and an immunohistochemical (IHC) assay to investigate S15 expression in solid tumors.
NC410

Presented in vivo data at the 2022 Extracellular Matrix (ECM) Pharmacology Congress in Copenhagen that demonstrated NC410 remodels tumor ECM, enhances immune cell infiltration, alleviates immunosuppression, and reduces tumor growth in a humanized mouse tumor model.
Announced that collaborator Brahm Segal, M.D., of Roswell Park Comprehensive Cancer Center shared nonclinical data from a research study that models the ability of NC410 to block neutrophil-mediated suppression of T cells in a tumor microenvironment (TME) at the 24th Translational Research Cancer Centers Consortium Annual Meeting. In addition, NextCure appointed Dr. Segal to its Scientific Advisory Board (SAB).
Expected Upcoming Milestones

The company remains on track for the following 2022 milestones:

NC318 (S15 mAb) Phase 2 update: fourth quarter of 2022 (Amended Phase 2 with patient selection and increased dosing).
NC318 (S15 mAb) anti-PD-1 combo initial data: second half of 2022 (Yale University Investigator-Initiated trial).
NC410 (LAIR-2 fusion) Phase 1 update: second half of 2022.
NC762 (B7-H4 mAb) Phase 1 initial data: second half of 2022.
NC525 (LAIR-1 mAb) Investigational New Drug (IND) Application filing: fourth quarter of 2022.
Financial Guidance

Based on its current research and development plans, NextCure expects its existing cash, cash equivalents and marketable securities will enable it to fund operating expenses and capital expenditures into the first quarter of 2024.

Financial Results for Quarter Ended June 30, 2022

Cash, cash equivalents, and marketable securities, excluding restricted cash as of June 30, 2022, were $185.5 million as compared to $219.6 million as of December 31, 2021. The decrease of $34.1 million primarily related to cash used to fund operations, cash used to purchase fixed assets, and changes in the fair value of our marketable securities.
Research and development expenses were $12.8 million for the quarter ended June 30, 2022, as compared to $11.9 million for the quarter ended June 30, 2021. The increase of $0.9 million was driven primarily by additional clinical and lab-related costs.
General and administrative expenses were $5.3 million for the quarter ended June 30, 2022, as compared to $6.0 million for the quarter ended June 30, 2021. The decrease of $0.7 million was primarily related to reduced professional services and personnel-related costs.
Net loss was $17.9 million for the quarter ended June 30, 2022, as compared with a net loss of $18.0 million for the quarter ended June 30, 2021. The changes in net loss from the previous year’s quarter was primarily due to higher interest income and lower general administrative expenses offset by increased research and development expenses.

On August 4, 2022 Geron Corporation (Nasdaq: GERN) reported that it will release its second quarter 2022 financial results after the market closes on Thursday, August 11, 2022 via press release, which will be available on the Company’s website at www.geron.com/investors (Press release, Geron, AUG 4, 2022, View Source [SID1234617562]). Geron will host a conference call to discuss the financial results as well as key upcoming expected milestones at 4:30 p.m. ET the same day.

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A live webcast of the conference call and related presentation will be available on the Company’s website at www.geron.com/investors/events. An archive of the webcast will be available on the Company’s website for 30 days.

Participants may access the webcast by registering online using the following link, View Source Participants that are unable to register online can access the conference call via telephone by dialing domestically +1 (888) 330-2434 or internationally +1 (240) 789-2725. The conference ID is 67335.

On August 4, 2022 BioVaxys Technology Corp. (CSE: BIOV) (FRA: 5LB) (OTCQB: BVAXF) ("BioVaxys" or the "Company") reported a non-brokered private placement (the "Private Placement") consisting of up to 10,000,000 units ("Units") at a price of $0.10 per Unit for total gross proceeds of up to approximately $1,000,000 (Press release, BioVaxys Technology, AUG 4, 2022, View Source [SID1234617578]). Each Unit consists of one common share (a "Common Share") and one whole Common Share purchase warrant (a "Warrant") . Each Warrant is exercisable for one additional Common Share at an exercise price of $0.20 for a period of 48 months.

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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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All securities issued pursuant to the Private Placement are subject to a statutory hold period of four months and one day from the date of issuance. The Company may pay cash finder’s fees on all or a portion of the Private Placement.

The Company intends to use the net proceeds of the Private Placement for working capital purposes. Closing of the Private Placement is subject customary conditions of closing, including the approval of the Canadian Securities Exchange, and is expected to complete on or about August 19th, 2022.

On August 4, 2022 Knight Therapeutics Inc. (TSX: GUD) ("Knight"), a leading pan-American (ex-USA) specialty pharmaceutical company, reported that will release its second quarter 2022 financial results on Thursday, August 11, 2022 prior to market opening (Press release, Knight Therapeutics, AUG 4, 2022, View Source [SID1234617594]). Following the release, Knight will hold a conference call and audio webcast. Knight cordially invites all interested parties to participate in this call.

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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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On August 4, 2022 SQZ Biotechnologies (NYSE: SQZ), focused on unlocking the full potential of cell therapies for multiple therapeutic areas, reported second quarter 2022 financial results and recent portfolio updates (Press release, SQZ Biotech, AUG 4, 2022, View Source [SID1234617609]).

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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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"We are excited by meaningful progress in our clinical trials and also the receipt of FDA Fast Track Designation for our APC clinical candidate across HPV16+ tumors," said Armon Sharei, Ph.D., CEO and Founder at SQZ Biotechnologies. "We also highlighted the progress in developing our Point-of-Care manufacturing system which supports our long-term vision to enable broad accessibility of cell therapies. Finally, I am delighted by the addition of our newest senior team member, Dr. Marshelle Smith Warren as our Chief Medical Officer, and the elevation of Micah Zajic to Chief Financial Officer."

Second Quarter 2022 and Recent Portfolio Updates

SQZ Antigen Presenting Cell ("APC") Platform in Oncology

Granted FDA Fast Track Designation for SQZ-PBMC-HPV, our APC clinical candidate, for HPV16+ advanced or metastatic tumors
Continued enrollment of high dose monotherapy and combination with checkpoint inhibitors in the Phase 1/2 (SQZ-PBMC-HPV) trial
SQZ Enhanced Antigen Presenting Cell ("eAPC") Platform in Oncology

Presented SQZ eAPC preclinical data at the American Association for Cancer Research (AACR) (Free AACR Whitepaper) annual meeting demonstrating that delivery of multiple mRNAs encoding for disease-specific antigens and immune stimulators had a synergistic effect that substantially increased killer T cell activity in humanized mouse models
Initiated enrollment and opened additional sites for the monotherapy stage of the COMMANDER-001 Phase 1/2 (SQZ-eAPC-HPV) trial
SQZ Activating Antigen Carriers ("AAC") Platform in Oncology

Published trial in progress poster at the AACR (Free AACR Whitepaper) annual meeting highlighting the SQZ AAC platforms potential to drive robust CD8 T cell activation and tumor killing
Continued enrollment and opened additional sites for the monotherapy stage of the ENVOY-001 Phase 1/2 (SQZ-AAC-HPV-101) trial
SQZ Tolerizing Antigen Carriers ("TAC") Platform in Immune Tolerance

Published comprehensive preclinical research in Frontiers in Immunology
Progressed studies supporting anticipated TAC IND submission for celiac disease in the first half of 2023; company’s POC manufacturing system intended to produce clinical batches
SQZ Point-of-Care Manufacturing

Presented non-clinical POC manufacturing performance data at the American Society for Gene and Cell Therapy (ASGCT) (Free ASGCT Whitepaper) annual meeting demonstrating reduced manufacturing time and comparable or improved product specifications relative to current cleanroom-based processes
Recent Corporate Highlights

Appointed two experienced executives to leadership roles: Marshelle Smith Warren, M.D. joined as Chief Medical Officer, and Micah Zajic was elevated to Chief Financial Officer
Second Quarter 2022 Financial Highlights

Revenue for the quarter ended June 30, 2022, was $3.2 million compared to $4.5 million for the same period in 2021
Research and development expenses for the quarter ended June 30, 2022, were $18.8 million compared to $17.7 million for the same period in 2021; the increase was primarily due to higher personnel-related costs including stock-based compensation expense, to support continued progress with the company’s pipeline
General and administrative expenses for the quarter ended June 30, 2022, were $7.0 million compared to $5.9 million for the same period in 2021; the increase was primarily due to higher personnel and other corporate-related costs, including stock-based compensation expense and other costs
Net loss for the quarter ended June 30, 2022, was $22.2 million, compared to $19.1 million for the same period in 2021
As of June 30, 2022, the Company had cash and cash equivalents of $105.6 million and anticipates this will be sufficient to fund operating expenses and capital expenditure requirements into the fourth quarter of 2023