On March 1, 2023 Omega Therapeutics, Inc. (Nasdaq: OMGA) ("Omega"), a clinical-stage biotechnology company pioneering the development of a new class of programmable epigenetic mRNA medicines, reported financial results for the fourth quarter and full year ended December 31, 2022 and provided a corporate update (Press release, Omega Therapeutics, MAR 1, 2023, View Source [SID1234627948]).

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"2022 was a pivotal year for Omega, marked by tremendous progress and consistent execution. Our first programmable epigenetic mRNA medicine, OTX-2002, received IND clearance and orphan drug designation from the FDA and we launched our landmark MYCHELANGELO I clinical trial for the treatment of hepatocellular carcinoma and other solid tumor types known for association with the MYC oncogene. We also made significant advancements across our pipeline, including the selection of our second development candidate, OTX-2101 for MYC-driven non-small cell lung cancer with a novel lung-targeting lipid nanoparticle, and characterized our CXCL1-8 preclinical program in multiple potential indications," said Mahesh Karande, President and Chief Executive Officer of Omega Therapeutics.

"This year, we aim to generate clinical proof-of-platform through MYCHELANGELO I and replicate our preclinical findings for OTX-2002. In addition to characterizing safety and tolerability, we are collecting translational data, assessing epigenetic state changes, correlating mRNA and protein changes, and evaluating anti-tumor activity," Karande continued. "We are excited at the prospect to deliver on the promise of epigenetics and make a meaningful impact on transforming medicine in service of patients. With additional capital from our recently completed registered direct offering further strengthening our balance sheet, we believe we are well positioned to build on our momentum through the potential value inflection milestones this year

Recent Corporate Highlights and Upcoming Anticipated Milestones

Development Pipeline and Platform

Advanced MYCHELANGELO I Clinical Trial for OTX-2002, the Company’s Lead Omega Epigenomic Controller (OEC): Enrollment continues in the Phase 1/2 trial evaluating OTX-2002 as a monotherapy (Part I) and in combination with standard of care therapies (Part 2) in patients with relapsed or refractory hepatocellular carcinoma (HCC) and other solid tumor types known for association with the c-Myc (MYC) oncogene. Trial enrollment is progressing as planned with multiple clinical sites initiated across the U.S. and Asia; additional sites are expected to activate in these regions. Preliminary data from the Phase 1 monotherapy dose escalation portion of the study are anticipated in 2023.
•
Presented a Trial-in-Progress Poster at ASCO (Free ASCO Whitepaper) Gastrointestinal Cancers Symposium: In January 2023, a trial-in-progress poster titled "A phase 1/2 open-label study to evaluate the safety, tolerability, pharmacokinetics, pharmacodynamics, and preliminary antitumor activity of OTX-2002 as a single agent and in combination with standard of care in patients with hepatocellular carcinoma and other solid tumor types known for association with the MYC oncogene (MYCHELANGELO I)" was presented at the American Society for Clinical Oncology 2023 Gastrointestinal Cancers Symposium (ASCO-GI).
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Advanced Preclinical Development of Multiple OEC Programs: The Company continues to advance multiple OECs from the OMEGA platform through preclinical studies. OTX-2101, declared as Omega’s second development candidate, is being evaluated in Investigational New Drug (IND)-enabling studies for the treatment of MYC-driven non-small cell lung cancer (NSCLC), an area of significant unmet patient need. The CXCL 1-8-targeting OEC has been characterized in preclinical studies and has potential in several indications including neutrophilic asthma, acute respiratory distress syndrome (including COVID-related), oncology, and dermatological and rheumatological indications, representing a potential franchise opportunity.

Corporate

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Strengthened Balance Sheet with Registered Direct Offering: In February 2023, the Company closed a registered direct offering of its common stock resulting in net proceeds of approximately $39.7 million. The offering included participation from new and existing investors.
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Recognized for Culture and Innovation in Industry Awards: In November 2022, BioSpace named Omega among its Best Places to Work 2023 report in the small employers category. The Company was also named as a finalist for the Reuters Events Pharma Awards USA 2022 in the Health Entrepreneur category

Fourth Quarter and Full Year 2022 Financial Results

As of December 31, 2022, the Company had cash, cash equivalents and marketable securities totaling $124.7 million. Subsequent to the close of 2022, the Company received approximately $39.7 million in net proceeds from a registered direct offering of common stock.

Research and development (R&D) expenses for the fourth quarter of 2022 were $25.7 million, compared to $14.7 million for the fourth quarter 2021. R&D expenses for 2022 were $80.0 million compared to $47.9 million in 2021. The $32.1 million increase in R&D expenses in 2022 compared to 2021 was primarily due to increases in discovery and preclinical development costs, clinical development costs, and personnel and related expenses as the Company continues to advance its pipeline and discovery portfolio.

General and administrative (G&A) expenses for the fourth quarter of 2022 were $5.4 million, compared with $5.7 million for the fourth quarter of 2021. G&A expenses for 2022 were $21.8 million, compared to $16.6 million in 2021. The $5.2 million increase in G&A expenses in 2022 compared to 2021 was primarily due to higher personnel and related expenses and increased costs to operate as a public company, in addition to higher professional fees to support business growth.

Net loss for the fourth quarter of 2022 was $30.8 million, compared with $20.9 million for the fourth quarter of 2021. Net loss for the year ended December 31, 2022 was $102.7 million, compared to a net loss of $68.3 million for the year ended December 31, 2021. The increase in net loss for 2022 compared to 2021 was primarily due to increases in R&D and G&A expenses to support the Company’s growth and operations as a public company.

On March 1, 2023 Kura Oncology, Inc. (Nasdaq: KURA), a clinical-stage biopharmaceutical company committed to realizing the promise of precision medicines for the treatment of cancer, reported that Troy Wilson, Ph.D., J.D., President and Chief Executive Officer, is scheduled to participate in the following events at upcoming investor conferences (Press release, Kura Oncology, MAR 1, 2023, View Source [SID1234627947]).

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A "Leukemia Corporate Panel" discussion at the Cowen Health Care Conference in Boston at 12:50 p.m. ET / 9:50 a.m. PT on March 8, 2023;

A fireside chat at the Cowen Health Care Conference at 2:50 p.m. ET / 11:50 a.m. PT on March 8, 2023; and

A fireside chat at the Barclays Global Healthcare Conference in Miami at 2:35 p.m. ET / 11:35 a.m. PT on March 14, 2023.
Live audio webcasts will be available in the Investors section of Kura’s website at www.kuraoncology.com, with archived replays available following the events.

On March 1, 2023 Iovance Biotherapeutics, Inc. (NASDAQ: IOVA), a late-stage biotechnology company developing novel T cell-based cancer immunotherapies, reported that senior leadership plans to present at the following conferences (Press release, Iovance Biotherapeutics, MAR 1, 2023, View Source [SID1234627946]).

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H.C. Wainwright Cell Therapy Virtual Conference
Fireside Chat: February 28, 2023, on-demand
Virtual
Cowen Health Care Conference
Fireside Chat: March 7, 2023 at 2:50 p.m. ET
Boston, MA
Oppenheimer 33rd Annual Healthcare Conference
Presentation: March 14, 2023 at 2:00 p.m. ET
Virtual
Barclays 2023 Global Healthcare Conference
Fireside Chat: March 15, 2023 at 1:35 p.m. ET
Miami, FL
The live and archived webcasts will be available at View Source

On March 1, 2023 ImmunoGen, Inc. (Nasdaq: IMGN), a leader in the expanding field of antibody-drug conjugates (ADCs) for the treatment of cancer, reported its recent progress in the business and reported financial results for the quarter and year ended December 31, 2022 (Press release, ImmunoGen, MAR 1, 2023, View Source [SID1234627945]).

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"We significantly advanced the business on multiple fronts over the last 12 months, most notably with the accelerated approval and launch of ELAHERE for patients with platinum-resistant ovarian cancer," said Mark Enyedy, ImmunoGen’s President and Chief Executive Officer. "We have seen broad and deep adoption of ELAHERE to date, with FRα testing, managed care coverage, and provider access all exceeding our expectations. Building upon this progress and in line with our goal of obtaining full approval for ELAHERE in the US and expanding into Europe, we will imminently reach the requisite number of PFS events in the confirmatory MIRASOL trial and expect to announce top-line data in the second quarter. In parallel, we are pursuing our broader development program in support of moving ELAHERE into platinum-sensitive disease and positioning ELAHERE as the combination agent of choice in ovarian cancer."

Enyedy continued, "Turning to our second pivotal program, pivekimab sunirine, we presented promising findings from our triplet expansion cohorts in AML in an oral presentation at ASH (Free ASH Whitepaper) in December, and continued enrollment in the pivotal CADENZA trial in frontline BPDCN with top-line data in de novo patients anticipated in 2024. We are also progressing our earlier-stage portfolio with the completion of dose escalation in the Phase 1 study of IMGC936, while also having dosed the first patient in our Phase 1 trial for IMGN151 in January. Combining our commitment to advance our pipeline of novel ADCs along with driving the commercial uptake of ELAHERE in the US, we are well positioned for another exciting and productive year."

RECENT PROGRESS

ELAHERE (mirvetuximab soravtansine-gynx)

Received US Food and Drug Administration (FDA) accelerated approval of ELAHERE for folate receptor alpha (FRα)-positive platinum-resistant ovarian cancer (PROC) on November 14, 2022.
Generated $2.6 million in net sales for the fourth quarter of 2022.
ELAHERE monotherapy and in combination with bevacizumab included in the National Comprehensive Cancer Network (NCCN) Clinical Practice Guidelines and compendium.
Clinical Pipeline

Published manuscript on the safety and efficacy of mirvetuximab in PROC in the SORAYA trial in the Journal of Clinical Oncology.
Published manuscript on the safety and efficacy of mirvetuximab in combination with bevacizumab in PROC in Gynecologic Oncology.
Completed enrollment in PICCOLO, a single-arm study of mirvetuximab monotherapy in FRα-high recurrent platinum-sensitive ovarian cancer (PSOC).
Presented data from expansion cohorts in the Phase 1b/2 study evaluating the pivekimab sunirine (pivekimab) triplet with Vidaza (azacitidine) and Venclexta (venetoclax) in relapsed/refractory (R/R) and initial data in frontline unfit acute myeloid leukemia (AML) in an oral presentation at the 2022 American Society of Hematology (ASH) (Free ASH Whitepaper) Annual Meeting in December.
Progressed the pivotal Phase 2 CADENZA study of pivekimab sunirine (pivekimab) in frontline and relapsed/refractory (R/R) blastic plasmacytoid dendritic cell neoplasm (BPDCN).
Completed dose escalation in the Phase 1 study of IMGC936 in multiple solid tumor types and initiated expansion cohorts in triple-negative breast cancer (TNBC) and non-small cell lung cancer (NSCLC).
Enrolled the first patient in the Phase 1 study of IMGN151 in January 2023.
Corporate Development

Announced a global, multi-target license and option agreement granting Vertex Pharmaceuticals rights to conduct research using ImmunoGen’s ADC technology to discover novel targeted conditioning agents for use with gene editing in exchange for a $15 million upfront payment and up to $337 million in potential option exercise fees, development and commercial milestones, and tiered royalties on a per target basis.
Announced a clinical collaboration with Gilead to evaluate the safety and anti-leukemia activity of pivekimab in combination with magrolimab, a potential first-in-class CD47 inhibitor, in patients with R/R CD123-positive AML.
Appointed Michael Vasconcelles, MD, as Executive Vice President, Research, Development, and Medical Affairs, and Daniel Char, JD, as Senior Vice President and Chief Legal Officer.
ANTICIPATED UPCOMING EVENTS

Report top-line data for MIRASOL in the second quarter of 2023.
Submit the Marketing Authorization Application (MAA) to the European Medicines Agency (EMA) for ELAHERE in FRα-high PROC in the second half of 2023 to support potential approval and launch.
Submit the supplemental Biologics License Application (sBLA) to the FDA in the second half of 2023 to support the conversion of the accelerated approval of ELAHERE to a full approval.
Our partner, Huadong Medicine, to submit the biologics license application (BLA) to the National Medical Products Administration (NMPA) of China for ELAHERE in FRα-high PROC in the second half of 2023 to support potential approval and launch.
Present efficacy data from the SORAYA trial by sequence of treatment and final overall survival analysis at the Society of Gynecologic Oncology (SGO) 2023 Annual Meeting in March.
Report on the primary endpoint for PICCOLO before the end of 2023.
Complete enrollment of the efficacy evaluable cohort of de novo BPDCN patients in the pivotal phase 2 CADENZA study by the end of 2023.
Initiate the combination cohort of pivekimab with magrolimab in R/R AML in collaboration with Gilead in the second half of 2023.
Report dose escalation data in Phase 1 trial of IMGC936 and initial experience in expansion cohorts in the second quarter of 2023.
FINANCIAL RESULTS
Total revenues were $41.2 million for the quarter ended December 31, 2022 compared to $28.0 million for the quarter ended December 31, 2021, and $108.8 million for the year ended December 31, 2022 compared to $69.9 million for the year ended December 31, 2021. The increase in the quarter ended December 31, 2022 was primarily driven by one-time milestone payments achieved pursuant to the Company’s license and collaboration agreements with Huadong Medicine and Viridian Therapeutics. In addition to greater partner milestones achieved, the increase for the current year was driven by one-time license fees received pursuant to agreements executed with Eli Lilly and Magenta Therapeutics in 2022, as well as greater amortization in 2022 of the $40.0 million upfront fee previously received pursuant to the Company’s collaboration agreement with Huadong Medicine. The Company also recorded $2.6 million in net product revenue from sales of ELAHERE for the quarter and year ended December 31, 2022.

Research and development expenses rose to $58.5 million for the quarter ended December 31, 2022 compared to $49.0 million for the quarter ended December 31, 2021, and $213.4 million for the year ended December 31, 2022 compared to $151.1 million for the year ended December 31, 2021. The increases in both periods were driven by greater personnel and temporary staffing costs, external manufacturing costs, and third-party service fees, including medical affairs’ activities in support of the US commercial launch of ELAHERE in the fourth quarter of 2022, as well as greater clinical trial expenses. Additionally, research and development expenses for the year ended December 31, 2022 included $8.9 million of research costs to expand our ADC pipeline, inclusive of a one-time $7.5 million upfront fee paid to Oxford BioTherapeutics.

Selling, general and administrative expenses were $42.1 million for the quarter ended December 31, 2022 compared to $13.6 million for the quarter ended December 31, 2021, and $116.1 million for the year ended December 31, 2022 compared to $43.8 million for the year ended December 31, 2021. The increases in both periods were due primarily to building our commercial infrastructure and capabilities, including personnel-related costs and sales and marketing activities in support of the US launch of ELAHERE in the fourth quarter of 2022.

Net loss for the fourth quarter of 2022 was $59.0 million, or $0.23 per diluted share, compared to net loss of $37.2 million, or $0.17 per diluted share, for the fourth quarter of 2021. Net loss for the year ended December 31, 2022 was $222.9 million, or $0.88 per diluted share, compared to a net loss of $139.3 million, or $0.68 per diluted share, for the year ended December 31, 2021.

ImmunoGen had $275.1 million in cash and cash equivalents as of December 31, 2022, compared with $478.8 million as of December 31, 2021. Cash used in operations was $229.8 million for the year ended December 31, 2022 compared with $169.4 million for the year ended December 31, 2021. Capital expenditures were $1.4 million in each of the years ended December 31, 2022 and 2021.

During the quarter ended December 31, 2022, the Company sold 5.2 million shares of its common stock through its At-the-Market facility, generating net proceeds to the Company of $25.6 million.

FINANCIAL GUIDANCE
For 2023, ImmunoGen expects:

revenues, excluding product revenue from ELAHERE, between $30 million and $35 million; and
operating expenses between $310 million and $320 million.
ImmunoGen expects to provide ELAHERE product revenue guidance later this year.

Excluding anticipated ELAHERE and collaboration revenue, our level of cash and cash equivalents as of December 31, 2022, alone is not sufficient to meet our current operating plans through March 1, 2024. With the addition of forecasted ELAHERE product revenue and milestone payments under existing collaboration agreements, we expect these amounts combined with existing cash and cash equivalents will fund operations for more than 12 months from the date of this release. The Company intends to raise additional funds through equity, debt, or other financings.

CONFERENCE CALL INFORMATION
ImmunoGen will hold a conference call today at 8:00 a.m. ET to discuss these results. To access the live call by phone, please register here. A dial-in and unique PIN will be provided to join the call. The call may also be accessed through the Investors and Media section of the Company’s website, www.immunogen.com. Following the call, a replay will be available at the same location.

ABOUT ELAHERE (MIRVETUXIMAB SORAVTANSINE-GYNX)
ELAHERE (mirvetuximab soravtansine-gynx) is a first-in-class ADC comprising a folate receptor alpha-binding antibody, cleavable linker, and the maytansinoid payload DM4, a potent tubulin inhibitor designed to kill the targeted cancer cells.

ELAHERE is indicated for the treatment of adult patients with folate receptor-alpha (FRα) positive, platinum-resistant epithelial ovarian, fallopian tube, or primary peritoneal cancer, who have received one to three prior systemic treatment regimens. Select patients for therapy based on an FDA-approved test.

This indication is approved under accelerated approval based on tumor response rate and durability of response. Continued approval for this indication may be contingent upon verification and description of clinical benefit in a confirmatory trial.

Eye problems are common with ELAHERE and can be severe. ELAHERE also can cause severe or life-threatening inflammation of the lungs that may lead to death and patients may develop nerve problems called peripheral neuropathy during treatment. Please see full Prescribing Information, including Boxed Warning, and Medication Guide for ELAHERE.

On March 1, 2023 G1 Therapeutics, Inc. (Nasdaq: GTHX), a commercial-stage oncology company, reported a corporate and financial update for the fourth quarter and full year ended December 31, 2022 (Press release, G1 Therapeutics, MAR 1, 2023, View Source [SID1234627944]).

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"Since the start of 2022, the G1 team has achieved the milestones we put forth at the beginning of the year and did so with the resolve expected of a company focused on the needs of the cancer patients we seek to treat," said Jack Bailey, Chief Executive Officer of G1 Therapeutics. "Since announcing the results of PRESERVE 1 last month, we’ve moved forward with urgency on the rest of the business. First, we remain confident in the small cell lung cancer business and have returned growth to COSELA sales through February 2023. Second, we are aggressively executing on our ongoing clinical trials, including the Phase 2 ADC and MOA trials in TNBC, each of which provided compelling initial results late in 2022 and have additional readouts expected in the second quarter of this year. And third, we have moved quickly to make necessary reductions to the organization and our expenses to extend our cash runway through each of our ongoing clinical trials."

Continued Bailey, "On behalf of the G1 team, I’d also like to express my gratitude to Jen Moses for her dedication to our company, our vision, and the patients we seek to treat. Jen has been with G1 since 2015 and became our Chief Financial Officer in 2019; her financial leadership throughout that period has been exceptional. We wish her continued success in her next professional chapter."

Fourth Quarter 2022 and Recent Highlights

Financial

Achieved $8.9 Million and $31.3 Million in Net COSELA Revenue for the Fourth Quarter and Full Year 2022: Results represent a 102% increase and a 182% increase over the corresponding periods in 2021. G1 recognized total revenues of $10.3 million and $51.3 million for the fourth quarter and full year of 2022, respectively.

Completed Public Offering Resulting in $52.0 Million in Net Proceeds: In November 2022, G1 closed an underwritten public offering of its common stock at a public offering price of $6.50 per share.

Ended the Fourth Quarter 2022 with Cash, Cash Equivalents, and Marketable Securities of $145.1 Million.
Clinical

Announced Top Line Results from Pivotal Phase 3 Trial of Trilaciclib in Patients Receiving FOLFOXIRI + Bevacizumab for Metastatic Colorectal Cancer (CRC) (PRESERVE 1): G1 announced top line results from its pivotal Phase 3 PRESERVE 1 trial showing that the trial achieved its co-primary endpoints related to severe neutropenia with statistical significance (p<0.001). These results further validate the myeloprotection benefit of trilaciclib. Despite the achievement of the co-primary endpoints and other secondary measures of myeloprotection and tolerability, early anti-tumor efficacy data, including overall response rate, favored patients receiving placebo compared to trilaciclib. Given the differential in these anti-tumor efficacy metrics and the low likelihood of achieving the progression-free survival and overall survival (OS) endpoints, G1 has discontinued PRESERVE 1. (Press release here)

Completed Enrollment in Pivotal Phase 3 Clinical Trial of Trilaciclib in Patients with mTNBC: Enrollment in PRESERVE 2 is complete at 187 patients receiving first line trilaciclib or placebo prior to gemcitabine and carboplatin (GC). The primary endpoint is to evaluate the effect of trilaciclib on OS compared with placebo in patients receiving first-line GC (press release here). The interim OS analysis will be conducted by its data monitoring committee at 70% of events. Based on recent evaluations, the number of actual events appears to be occurring more slowly than predicted. As a result, G1 now expects the interim OS analysis to be conducted in the first half of 2024. If the trial meets the interim analysis stopping rule, it will terminate, and G1 will report the top line results. If it does not, the trial will continue to the final analysis.

Announced Initial Results from Phase 2 Trial of Trilaciclib in Combination with an Antibody-Drug Conjugate: Initial Phase 2 safety data suggest on-target effect of trilaciclib to reduce (>50%) the rates of adverse events associated with the ADC sacituzumab govitecan-hziy, including myelosuppression and diarrhea, relative to the previously published sacituzumab single agent safety profile. The Company anticipates disclosure of a more comprehensive data set including safety and initial efficacy results at a medical meeting in the second quarter 2023. (Press release here)

Confirmed that Initial Results Including the Primary Endpoint of Progression Free Survival from Phase 2 Bladder Cancer Trial of Trilaciclib (PRESERVE 3) Are Anticipated Midyear 2023: G1 has reiterated that additional safety and efficacy results, including results from the primary endpoint of Progression Free Survival, are expected from PRESERVE 3 midyear 2023. (Press release here)
Medical

Presented Results from Phase 2 Mechanism of Action Trial at the San Antonio Breast Cancer Symposium (SABCS) Showing That Trilaciclib Favorably Alters the Tumor Microenvironment: G1 provided initial results from a 24 patient Phase 2 mechanism of action (MOA) trial showing favorable alterations in the tumor microenvironment from a single dose of trilaciclib monotherapy as measured by increases in the proportions of CD8+ T cells compared to T regulatory cells (Tregs) in patients with early-stage triple negative breast cancer (TNBC). (Press release here)

Presented Nonclinical Study Results at the 2022 Society for Immunotherapy of Cancer (SITC) (Free SITC Whitepaper) Conference Elucidating Immune Effects of Trilaciclib: New nonclinical data show that trilaciclib upregulates key processes within the cancer immunity cycle including that trilaciclib enhances the differentiation of CD8+ T cells into effector memory and central memory T cell populations. In addition, trilaciclib can increase antigen presentation on tumor cells by upregulating HMC Class I and II, and promote T cell recruitment to tumor cells. (Press release here)
Corporate

Reduced Headcount and Associated Expenses to Extend Cash Runway Beyond Clinical Trial Readouts: G1 completed a reduction in force of approximately 30%, though the COSELA sales team remains intact. As a result of this and other reductions in spend, G1 currently expects its 2023 operating expense to be 20% to 30% lower than that of 2022. With these adjustments to operating expenses, the top line guidance provided, and other assumptions around partner revenue, the Company believes this extends its cash runway through its upcoming readouts from its ongoing clinical trials.

Announced Executive Succession Plan: Jen Moses, G1’s Chief Financial Officer, will resign as of March 15, 2023, and will remain a senior advisor to the organization for one year. As of the date of her departure, G1’s Controller John W. Umstead V will be appointed to the role of CFO. Mr. Umstead has been with the Company since 2018. Prior to joining the Company, Mr. Umstead worked for PricewaterhouseCoopers LLP serving clients in various industries ranging from small private companies to large publicly traded corporations in a number of roles of increasing responsibility.
Fourth Quarter and Full Year 2022 Financial Results

As of December 31, 2022, cash and cash equivalents and marketable securities totaled $145.1 million, compared to $221.2 million as of December 31, 2021. This includes $52.0 million in net proceeds from a fourth quarter 2022 underwritten public offering of its common stock at a public offering price of $6.50 per share. Cowen and Raymond James acted as joint book-running managers for the offering. Needham & Company and Wedbush PacGrow acted as lead managers for the offering.

Total revenues for the fourth quarter of 2022 were $10.3 million, including $8.9 million in net product sales of COSELA and license revenue of $1.4 million, primarily related to clinical trial reimbursements from EQRx and Simcere, compared to a total of $5.8 million in total revenues in the fourth quarter of 2021. Total revenues for the full year 2022 were $51.3 million, including net product revenue of $31.3 million from sales of COSELA and license revenue of $20.0 million, compared to total revenues of $31.5 million for the prior year.

Operating expenses for the fourth quarter of 2022 were $41.1 million, compared to $43.4 million for the fourth quarter of 2021. GAAP operating expenses include stock-based compensation expense of $4.4 million for the fourth quarter of 2022, compared to $5.2 million for the fourth quarter of 2021. Operating expenses for the full year 2022 were $187.5 million, compared to $173.9 million for the prior year. Stock-based compensation expense for the full year 2022 was $20.6 million, compared to $22.3 million for the prior year.

Cost of goods sold expense for the fourth quarter of 2022 was $1.0 million compared to $0.4 million for the fourth quarter of 2021, primarily due to an increase in product sales. Cost of goods sold expense for the full year 2022 was $3.7 million, compared to $2.0 million for the prior year.

Research and development (R&D) expenses for the fourth quarter of 2022 were $16.6 million, compared to $19.8 million for the fourth quarter of 2021. The decrease in R&D expenses was primarily due to a decrease in the Company’s clinical program costs. R&D expenses for the full year 2022 were $83.3 million, compared to $76.2 million for the prior year.

Selling, general, and administrative (SG&A) expenses for the fourth quarter of 2022 were $23.6 million, compared to $23.2 million for the fourth quarter of 2021. The increase in SG&A expenses was due to increases in personnel costs and was offset by a decrease in payments to Boehringer Ingelheim and decreased professional and administrative expenses. SG&A expenses for the full year 2022 were $100.4 million, compared to $95.7 million for the prior year.

The net loss for the fourth quarter of 2022 was $33.6 million, compared to $40.0 million for the fourth quarter of 2021. Net loss for the full year 2022 was $147.6 million, compared to a net loss of $148.4 million for the prior year. The basic and diluted net loss per share for the fourth quarter of 2022 was $(0.73) compared to $(0.94) for the fourth quarter of 2021. The basic and diluted net loss per share for the full year 2022 was $(3.38) compared to $(3.54) for the prior year.

2023 Financial Guidance

G1 today provided full year 2023 financial guidance. The Company expects to generate between $50 million and $60 million in COSELA net revenue in 2023. G1’s product revenue guidance is based on expectations for continued acceleration of sales performance of COSELA in the U.S.

Webcast and Conference Call

G1 will host a webcast and conference call at 8:30 a.m. ET today to provide a corporate and financial update for the fourth quarter and full year ended December 31, 2022.

Please note that there is a new process to access the call via telephone. To register and receive a dial in number and unique PIN to access the live conference call, please follow this link to register online. While not required, it is recommended that you join 10 minutes prior to the start of the event. 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.

About COSELA (trilaciclib) for Injection

COSELA (trilaciclib) was approved by the U.S. Food and Drug Administration on February 12, 2021.

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.

This information is not comprehensive. 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.