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!

On May 5, 2021 Sana Biotechnology, Inc. (NASDAQ: SANA), a company focused on creating and delivering engineered cells as medicines, reported financial results and business highlights for the first quarter of 2021 (Press release, Sana Biotechnology, MAY 5, 2021, View Source [SID1234584006]).

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 continue to make progress across our platforms and pipeline, targeting a broad set of diseases," said Steve Harr, Sana’s President and Chief Executive Officer. "In the first quarter, we bolstered our balance sheet, continued to build our capabilities, and moved forward our science. We recently presented scientific data at a medical conference for the first time, highlighting the potential of both our in vivo delivery platform and our ex vivo hypoimmune platform to make innovative CAR T therapies for cancer patients. We look forward to presenting more scientific data and progress updates from our various pipeline programs at conferences this year."

Recent Corporate Scientific Highlights

Presented proof of concept animal studies from the in vivo fusogen T cell and ex vivo hypoimmune allogeneic T cell programs at the American Association for Cancer Research (AACR) (Free AACR Whitepaper) Annual Meeting 2021, highlighting the platforms’ ability to make potentially differentiated CAR T cells.
A single intravenous dose of targeted fusosomes enables specific delivery of a CD19 CAR transgene to CD8+ T cells, creating CAR T cells in vivo, that show a dose-dependent anti-tumor response regardless of prior T cell activation status.
Hypoimmunogenic CAR T cells show the ability to functionally evade the innate and adaptive immune system in allogeneic recipients and demonstrate tumor killing, potentially leading to universal CAR T cells that can persist without immunosuppression.
First Quarter 2021 Financial Results

GAAP Results

Cash Position: Cash, cash equivalents, and marketable securities as of March 31, 2021 were $981.9 million compared to $412.0 million as of December 31, 2020, an increase of $569.9 million. Sana successfully completed its initial public offering in February 2021 and issued 27.0 million shares of common stock, including 3.5 million shares pursuant to the full exercise of the underwriters’ option to purchase additional shares, at a price of $25.00 per share, for net proceeds of $626.4 million.
Research and Development Expenses: Research and development expenses for the three months ended March 31, 2021, inclusive of non-cash expenses, were $168.9 million compared to $27.3 million for the three months ended March 31, 2020. The increase of $141.6 million was primarily due to non-cash expenses for the increase in the estimated fair value of the success payment liabilities in aggregate and contingent consideration of $115.7 million and $11.4 million, respectively. The increase was also due to personnel-related expenses related to increased headcount to expand Sana’s research and development capabilities, costs for preclinical studies, laboratory supplies, and facility costs. Research and development expenses include stock-based compensation of $2.5 million for the three months ended March 31, 2021 and $0.6 million for the three months ended March 31, 2020.
General and Administrative Expenses: General and administrative expenses for the three months ended March 31, 2021, inclusive of non-cash expenses, were $11.8 million compared to $6.0 million for the three months ended March 31, 2020. The increases of $5.8 million was primarily due to increased personnel-related expenses attributable to an increase in headcount to build our infrastructure, consulting and legal fees, insurance associated with being a public company, and facility costs. General and administrative expenses include stock-based compensation of $1.5 million for the three months ended March 31, 2021 and $0.1 million for the three months ended March 31, 2020.
Net Loss: Net loss for the three months ended March 31, 2021 was $180.6 million, or $1.52 per share, compared to $32.9 million, or $3.04 per share, for the three months ended March 31, 2020.
Non-GAAP Measures

Non-GAAP Operating Cash Burn: Non-GAAP operating cash burn for the three months ended March 31, 2021 was $48.9 million compared to $29.5 million for the three months March 31, 2020. Non-GAAP operating cash burn is the decrease in cash, cash equivalents, and marketable securities excluding cash inflows from financing activities, cash outflows from business development activities, and the purchase of property and equipment.
Non-GAAP Research and Development Expenses: Non-GAAP research and development expenses for the three months ended March 31, 2021 were $41.9 million compared to $26.0 million for the three months ended March 31, 2020. Non-GAAP research and development expenses excludes one-time costs to acquire technology and non-cash expenses related to the change in the estimated fair value of contingent consideration and success payment liabilities.
Non-GAAP Net Loss: Non-GAAP net loss for the three months ended March 31, 2021 was $53.6 million, or $0.45 per share, compared to $31.6 million, or $2.92 per share, for the three months ended March 31, 2020. Non-GAAP net loss excludes one-time costs to acquire technology and non-cash expenses related to the change in the estimated fair value of contingent consideration and success payment liabilities.
A discussion of non-GAAP measures, including a reconciliation of GAAP and non-GAAP measures, is presented below under "Non-GAAP Financial Measures."

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]).

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 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.

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 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.

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!