On May 5, 2021 G1 Therapeutics, Inc. (Nasdaq: GTHX), a commercial-stage oncology company, reported a corporate and financial update for the first quarter ended March 31, 2021 (Press release, G1 Therapeutics, MAY 5, 2021, View Source [SID1234579203]).

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"The first quarter of 2021 was a transformational period for G1 as the approval and availability of COSELA provided extensive-stage small cell lung cancer patients undergoing chemotherapy with the first proactive multilineage myeloprotection therapy to help prevent myelosuppression," said Jack Bailey, Chief Executive Officer of G1 Therapeutics. "COSELA represents an opportunity to shift the treatment paradigm away from reactive treatments with multiple different single lineage therapeutic interventions. Our commercial team has demonstrated that we can effectively launch and deliver the drug during a very challenging time. Further, though very early in the launch period, leading and lagging indicators from the first four weeks of availability are encouraging and suggest that the awareness and interest in COSELA is strong, that it is being accepted by oncologists and oncology nurses, and that it is being well covered by payers. Another important step during the quarter was the inclusion of COSELA in two sets of NCCN Guidelines, which are the standard resource for determining best course of treatment and supportive care for people living with cancer. We also maintained clinical momentum in our tumor-agnostic development program for COSELA, including the initiation of PRESERVE 2, our Phase 3 registrational trial in triple-negative breast cancer."

First Quarter 2021 and Recent Highlights

Commercial

COSELA Approved by U.S. Food and Drug Administration (FDA): On February 12, 2021, the FDA approved COSELA for injection to decrease the incidence of chemotherapy-induced myelosuppression in adult patients when administered prior to a platinum/etoposide-containing regimen or topotecan-containing regimen for extensive-stage small cell lung cancer (ES-SCLC). (Press release here)
COSELA Now Available in the U.S.: On March 2, 2021, G1 and its commercial partner Boehringer Ingelheim announced that COSELA was available through G1’s specialty distributors Amerisource Specialty Distribution, Oncology Supply, McKesson Plasma and Biologics, McKesson Specialty and Cardinal Specialty. (Press release here)
Medical

COSELA Added to Two National Comprehensive Cancer Network (NCCN) Clinical Practice Guidelines in Oncology (NCCN Guidelines): On March 25, 2021, G1 announced that COSELA had been added to the Treatment Guidelines for Small Cell Lung Cancer and to the Supportive Care Guidelines for Hematopoietic Growth Factors. These guidelines document evidence-based, consensus-driven management to ensure that all patients receive preventive, diagnostic, treatment, and supportive services that are most likely to lead to optimal outcomes. (Press release here)
Presented New Budget Impact Data for COSELA at the Academy of Managed Care Pharmacy (AMCP) Meeting: These data described a model that compared ES-SCLC treatment scenarios with and without COSELA. The incremental cost of COSELA to a third-party payer is projected to be entirely offset by a reduction in the costs of managing adverse events related to myelosuppression. Therefore, the use of COSELA is estimated to provide cost savings.
Clinical

Initiated Pivotal Trial of COSELA in Patients Receiving First or Second Line Gemcitabine and Carboplatin Chemotherapy for Locally Advanced Unresectable or Metastatic Triple-Negative Breast Cancer (mTNBC): Patient enrollment is underway in PRESERVE 2, a randomized, double-blind, placebo-controlled Phase 3 registrational trial of COSELA in patients receiving first- or second-line gemcitabine/carboplatin (GC) chemotherapy for locally advanced unresectable or metastatic TNBC. (Press release here)
Entered Clinical Trial Collaboration for Upcoming First Line Locally Advanced or Metastatic Bladder Cancer (mUC) Trial of COSELA: G1 entered a clinical trial collaboration with the alliance between Merck KGaA, Darmstadt, Germany and Pfizer whereby the alliance will contribute clinical supply of the checkpoint inhibitor avelumab to the G1-sponsored and funded first-line mUC trial.
On Track to Initiate Two Phase 2 Trials of COSELA in First Line Metastatic Bladder Cancer (mUC) and Second Line / Third Line Non-Small Cell Lung Cancer (NSCLC) in the Second Quarter of 2021: The Company expects to initiate Phase 2 trials of COSELA in first-line treatment of locally advanced or metastatic bladder cancer (locally advanced or metastatic urothelial carcinoma, or mUC) and second- and third-line treatment of NSCLC, both of which are known immunogenic tumors, in the second quarter of 2021. Both trials are designed to evaluate the anti-tumor efficacy of COSELA.
First Quarter 2021 Financial Results

As of March 31, 2021, cash and cash equivalents totaled $279.0 million, compared to $207.3 million as of December 31, 2020. This includes $86.4 million in net proceeds in the first quarter from the "At the Market" offering with Cowen and Company, LLC. This ATM offering is now closed. In addition, the Company drew the additional $10M available in the first tranche of debt on its debt financing facility with Hercules Capital. The Company has access to an additional $70 million through this facility.

Total revenue for the first quarter of 2021 was $14.2 million, including approximately $0.6 million in initial net product sales of COSELA and license revenue of $13.6 million, primarily related to development milestone payments from the Company’s license agreement with Simcere and revenue from EQRx related to delivery of clinical drug supply and manufacturing services and reimbursement of clinical trial costs with EQRx. In addition, the Company recognized revenue related to achievement of a development milestone by Genor.

Operating expenses for the first quarter of 2021 were $39.8 million, compared to $31.8 million for the first quarter of 2020. GAAP operating expenses include stock-based compensation expense of $5.9 million for the first quarter of 2021, compared to $4.7 million for the first quarter of 2020.

Cost of goods sold expense for the first quarter of 2021 were $0.2 million, compared to $0 for first quarter of 2020. The increase related to the Company’s period costs for the sales of COSELA.

Research and development (R&D) expenses for the first quarter of 2021 were $16.5 million, compared to $20.4 million for the first quarter of 2020. The decrease in R&D expenses was primarily due to a decrease in costs for manufacturing of active pharmaceutical ingredients and drug product to support clinical trials, as well as a decrease in external costs related to discovery and pre-clinical development.

Selling, general and administrative (SG&A) expenses for the first quarter of 2021 were $23.0 million, compared to $11.4 million for the first quarter of 2020. The increase in SG&A expenses was largely due to an increase in compensation due to increases in headcount and increased commercialization activities.

The net loss for the first quarter of 2021 was $26.4 million, compared to $31.0 million for the first quarter of 2020. The basic and diluted net loss per share for the first quarter of 2021 was $(0.65) compared to $(0.82) for the first quarter of 2020.

Financial Guidance

The Company expects its current financial position to be sufficient to fund its operations and capital expenditures into 2023.

Webcast and Conference Call

G1 will host a webcast and conference call at 4:30 p.m. ET today to provide a corporate and financial update for the first quarter 2021 ended March 31, 2021. The live call may be accessed by dialing (866) 763-6020 (domestic) or (210) 874-7713 (international) and entering the conference code: 2509548. A live and archived webcast will be available on the Events & Presentations page of the company’s website: www.g1therapeutics.com. The webcast will be archived on the same page for 90 days following the event.

Indication
COSELA (trilaciclib) is indicated to decrease the incidence of chemotherapy-induced myelosuppression in adult patients when administered prior to a platinum/etoposide-containing regimen or topotecan-containing regimen for extensive-stage small cell lung cancer.

Important Safety Information
COSELA is contraindicated in patients with a history of serious hypersensitivity reactions to trilaciclib.

Warnings and precautions include injection-site reactions (including phlebitis and thrombophlebitis), acute drug hypersensitivity reactions, interstitial lung disease (pneumonitis), and embryo-fetal toxicity.

The most common adverse reactions (>10%) were fatigue, hypocalcemia, hypokalemia, hypophosphatemia, aspartate aminotransferase increased, headache, and pneumonia.

Please click here for full Prescribing Information. View Source

To report suspected adverse reactions, contact G1 Therapeutics at 1-800-790-G1TX or call FDA at 1-800-FDA-1088 or visit www.fda.gov/medwatch.

On May 5, 2021 Genprex, Inc. ("Genprex" or the "Company") (NASDAQ: GNPX), a clinical-stage gene therapy company focused on developing life-changing therapies for patients with cancer and diabetes, reported that the Company has received centralized Institutional Review Board (IRB) approval of the clinical trial protocol for its upcoming Acclaim-1 clinical trial in non-small cell lung cancer (NSCLC) (Press release, Genprex, MAY 5, 2021, View Source [SID1234579219]). Acclaim-1 is an open-label, multi-center Phase 1/2 clinical trial that combines the Company’s lead drug candidate, REQORSA immunogene therapy, with AstraZeneca’s Tagrisso (osimertinib) in patients with late-stage NSCLC with mutated epidermal growth factor receptors (EGFRs), whose disease progressed after treatment with Tagrisso.

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"The purpose of IRB review is to assure that appropriate steps are taken to protect the rights and welfare of individuals participating as subjects in clinical research," said Rodney Varner, President and Chief Executive Officer of Genprex. "With this centralized IRB approval, we have achieved another significant clinical milestone. We remain focused on completing our preparations for the Acclaim-1 clinical trial, and look forward to its commencement."

An IRB is a U.S. Food and Drug Administration (FDA) registered constituted group of medical professionals that are responsible for reviewing and monitoring biomedical research involving human subjects. In accordance with FDA regulations, an IRB has the authority to approve, require modifications (to secure approval), or disapprove research. IRB group review serves an important role in the protection of the rights, safety and welfare of human research subjects.

A centralized IRB review process involves an agreement under which multiple study sites in a multicenter trial can rely on the review of a centralized IRB, other than the IRB affiliated with each individual research site. The goal of the centralized process is to increase efficiency and decrease duplicative efforts, while enabling the central IRB to take responsibility for all aspects of IRB review at each site participating in the centralized review process.

In January 2020, the Company received FDA Fast Track Designation for its Acclaim-1 patient population. Genprex has recently completed the manufacturing and scaled-up clinical grade production of REQORSA to supply drug product for its upcoming Acclaim clinical trials.

The Company expects to conduct the Acclaim-1 clinical trial at approximately 15 U.S. clinical sites with participation of approximately 92 patients (with up to 18 patients in the Phase 1 component and up to 74 patients in the Phase 2 component). An interim analysis will be performed after 25 clinical events (i.e., disease progression or death). Additional information on the Acclaim-1 clinical trial can be found by visiting ClinicalTrials.gov.

On May 5, 2021 Alkermes plc (Nasdaq: ALKS) reported that management will participate in a virtual fireside chat at the BofA Securities 2021 Healthcare Conference on Wednesday, May 12, 2021 at 2:45 p.m. ET (7:45 p.m. BST) (Press release, Alkermes, MAY 5, 2021, View Source [SID1234579236]). The presentation may be accessed under the Investors tab on www.alkermes.com and will be archived for 14 days.

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On May 5, 2021 ADC Therapeutics SA (NYSE: ADCT), a commercial-stage biotechnology company leading the development of novel antibody drug conjugates (ADCs) to treat hematological malignancies and solid tumors, reported ZYNLONTA (loncastuximab tesirine-lpyl) has been included in the latest National Comprehensive Cancer Network Clinical Practice Guidelines (NCCN Guidelines) in oncology for B-cell Lymphomas (Press release, ADC Therapeutics, MAY 5, 2021, View Source [SID1234579402]). Specifically, the NCCN Guidelines now include ZYNLONTA as a category 2A designation as a treatment option for adult patients with relapsed or refractory diffuse large B-cell lymphoma (DLBCL) after two or more lines of systemic therapy.

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"We were pleased to learn that less than two weeks after accelerated FDA approval, ZYNLONTA was added to the NCCN treatment guidelines with a category 2A recommendation," said Chris Martin, Chief Executive Officer of ADC Therapeutics. "Inclusion in the NCCN treatment guidelines highlights the high unmet medical need for a differentiated, targeted therapy in relapsed and refractory diffuse large B-cell lymphoma."

"The rapid inclusion of ZYNLONTA in the NCCN guidelines reinforces our work on behalf of patients who have been heavily pretreated and have difficult-to-treat disease," said Jay Feingold, MD, PhD, Senior Vice President and Chief Medical Officer of ADC Therapeutics. "Importantly, there is a broad range of pretreated patients needing new therapies, including those who are transplant eligible and ineligible, and patients who previously received stem cell transplant or CAR-T cell therapy."

On April 23, 2021, the U.S. Food and Drug Administration (FDA) granted accelerated approval to ZYNLONTA (loncastuximab tesirine-lpyl) for the treatment of adult patients with relapsed or refractory (r/r) large B-cell lymphoma after two or more lines of systemic therapy, including diffuse large B-cell lymphoma (DLBCL) not otherwise specified (NOS), DLBCL arising from low-grade lymphoma and also high-grade B-cell lymphoma. This indication was based on overall response rate. Continued approval for this indication may be contingent upon verification and description of clinical benefit in a confirmatory trial.

DLBCL, the most common type of non-Hodgkin lymphoma in the United States, is a rapidly progressing, aggressive disease that is heterogeneous with multiple subtypes.1 More than 40% of first-line DLBCL treatments fail.2 For patients who fail first-line therapy, prognoses are poor, worsening with each line of therapy as the chance for cure or long-term disease-free survival diminishes.3, 4

NCCN is a not-for-profit alliance of 31 leading cancer centers devoted to patient care, research, and education. NCCN is dedicated to improving and facilitating quality, effective, efficient, and accessible cancer care so patients can live better lives.

The updated NCCN guidelines are available at www.nccn.org.

About ZYNLONTATM (loncastuximab tesirine-lpyl)

ZYNLONTATM is a CD19-directed antibody drug conjugate (ADC). Once bound to a CD19-expressing cell, ZYNLONTA is internalized by the cell, where enzymes release a pyrrolobenzodiazepine (PBD) payload. The potent payload binds to DNA minor groove with little distortion, remaining less visible to DNA repair mechanisms. This ultimately results in cell cycle arrest and tumor cell death.

The U.S. Food and Drug Administration (FDA) has approved ZYNLONTA (loncastuximab tesirine-lpyl) for the treatment of adult patients with relapsed or refractory (r/r) large B-cell lymphoma after two or more lines of systemic therapy, including diffuse large B-cell lymphoma (DLBCL) not otherwise specified (NOS), DLBCL arising from low-grade lymphoma and also high-grade B-cell lymphoma. This indication is approved by the FDA under accelerated approval based on overall response rate and continued approval for this indication may be contingent upon verification and description of clinical benefit in a confirmatory trial.

ZYNLONTA is also being evaluated as a therapeutic option in combination studies in other B-cell malignancies and earlier lines of therapy.

United Therapeutics has filed a 10-Q – Quarterly report [Sections 13 or 15(d)] with the U.S. Securities and Exchange Commission .

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