On May 3, 2023 Horizon Therapeutics plc (Nasdaq: HZNP) reported first-quarter 2023 financial results (Press release, Horizon Pharma, MAY 3, 2023, View Source [SID1234630919]).

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"We generated strong first-quarter performance, with double-digit growth for KRYSTEXXA and UPLIZNA, and saw positive trends in TEPEZZA’s leading indicators as we exited the first quarter," said Tim Walbert, chairman, president and chief executive officer, Horizon. "Importantly, we announced positive topline results from our TEPEZZA clinical trial in low CAS and long-duration TED patients, as well as received FDA approval for an update to the TEPEZZA indication that reinforces the potential benefit of TEPEZZA, regardless of disease activity or duration. These important events will help us to ease the access burden so all eligible patients can benefit from TEPEZZA. I am extremely proud of what we have accomplished in a few short months and believe we are well positioned as we prepare to become part of Amgen."

Financial Highlights

(in millions except for per share amounts and percentages) Q1 23 Q1 22 %
Change
Net sales

$ 832.1 $ 885.2 (6 )
Net income

54.7 204.3 (73 )
Non-GAAP net income

194.3 315.8 (38 )
Adjusted EBITDA

232.9 371.2 (37 )
Earnings per share – diluted

0.23 0.87 (74 )
Non-GAAP earnings per share – diluted

0.83 1.34 (38 )
First-Quarter 2023 Net Sales Results

(in millions except for percentages) Q1 23 Q1 22 % Change
TEPEZZA

$ 405.3 $ 501.5 (19 )
KRYSTEXXA

187.0 140.7 33
RAVICTI

90.3 78.3 15
UPLIZNA(1)

53.8 30.5 77
PROCYSBI

50.5 49.6 2
ACTIMMUNE

29.1 31.3 (7 )
PENNSAID 2%(2)

9.2 35.4 (74 )
RAYOS

5.0 13.5 (63 )
BUPHENYL

1.4 2.2 (35 )
QUINSAIRTM

0.3 0.3 0
DUEXIS

0.1 1.1 (88 )
VIMOVO

0.1 0.9 (99 )

Total Net Sales

$ 832.1 $ 885.2 (6 )

(1)
First-quarter 2023 UPLIZNA net sales included $6.6 million in international net sales related primarily to revenue and milestone payments from the Company’s international partners. First-quarter 2022 UPLIZNA net sales included $5.2 million in international net sales.

(2)
On May 6, 2022, Apotex Inc. initiated an at-risk launch of generic PENNSAID 2% in the United States.

Key Growth Drivers

TEPEZZA: TEPEZZA net sales in the first quarter were $405 million, representing an 18 percent sequential decline compared to the fourth quarter of 2022. Net sales were impacted by seasonality, which the Company typically sees with its infused medicines in the first quarter each year. In addition, the TEPEZZA field-force expansion initiated late in 2022 has not yet substantially impacted net sales. More recently, the Company has seen the expansion drive positive momentum in the business, including increases in new prescribers, patient enrollment forms and patient starts. As new prescribers and patients work through the reimbursement process, the Company expects a more meaningful impact to net sales later in the year.

In April 2023, the Company announced positive topline results from its TEPEZZA Phase 4 clinical trial in patients with low CAS and long-duration TED and received FDA approval for an update to the indication for TEPEZZA that supports its potential benefit in TED, regardless of disease activity or duration. This reinforces the importance of unrestricted access for eligible patients across the full spectrum of TED and creates an opportunity to ease the access burden for patients and physicians and to decrease time to therapy for patients who may benefit from TEPEZZA. The Company plans to present data from the Phase 4 trial at a future medical congress and publish the data in a peer-reviewed medical journal to help educate key stakeholders, including physicians, patients and payors.

KRYSTEXXA: KRYSTEXXA first-quarter net sales were $187 million, representing a year-over-year increase of 33%. Sequentially, net sales declined by 13 percent compared to fourth-quarter 2022 due to seasonality. Strong performance in the first quarter was driven by the continued momentum in both the rheumatology and nephrology market segments, including the adoption of KRYSTEXXA with immunomodulation as the new standard of care following FDA approval in July 2022 for an expanded label to include KRYSTEXXA with methotrexate. The Company’s efforts to educate physicians and key stakeholders continues to lead to strong patient growth from both new and existing prescribers across both market segments.

UPLIZNA: UPLIZNA first-quarter 2023 net sales were $53.8 million, representing a year-over-year increase of 77%, driven by continued strong execution. Net sales in the U.S. were $47.2 million, an increase of 87%, and were driven by strong and consistent growth in new prescribers and new patient starts. The Company continues to advance its global expansion strategy with multiple planned international launches in 2023.

Conference Call

In light of the announced agreement to be acquired by Amgen Inc. and applicable securities laws, the Company will not be hosting a conference call to discuss its financial results. This earnings press release and the related Quarterly Report on Form 10-Q for the quarter ended March 31, 2023 are publicly available in the Investor Relations section of the Company’s website at View Source

On May 3, 2023 Gritstone bio, Inc. (Nasdaq: GRTS), a clinical-stage biotechnology company working to develop the world’s most potent vaccines, reported it will present its first quarter 2023 financial results and provide a corporate update following market close on Thursday, May 11, 2023 (Press release, Gritstone Bio, MAY 3, 2023, View Source [SID1234630917]). The announcement will be followed by a conference call and audio webcast, which will begin at 4:30pm ET.

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Live Conference Call & Webcast
Toll Free: 1-888-999-6281
International: 1-848-280-6550
Conference ID: 1754341
Webcast: View Source;tp_key=c6c637ac24

While not required, it is recommended you join five minutes prior to the event’s start. An archived replay will be accessible at View Source for 30 days following the event.

On May 3, 2023 GlycoMimetics, Inc. (Nasdaq: GLYC) a late clinical-stage biotechnology company discovering and developing glycobiology-based therapies for cancers and inflammatory diseases, reported its financial results and highlights for the first quarter ended March 31, 2023 (Press release, GlycoMimetics, MAY 3, 2023, View Source [SID1234630916]). Cash and cash equivalents as of March 31, 2023 were $65.0 million.

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"Thanks to the outstanding work of our team preparing the clinical trial database and evaluating the data from the recent interim utility analysis of our Phase 3 study of uproleselan in R/R AML, GlycoMimetics is well positioned to expeditiously complete final trial analysis following the final survival events trigger, which is projected to occur within the first half of 2024," said Harout Semerjian, Chief Executive Officer of GlycoMimetics. "We are optimistic and excited about the potential of uproleselan to improve overall survival in R/R AML and are fully focused on delivering on the potential of this important first-in-class therapy for patients in need of new, more effective treatment options."

Operational Highlights

Uproleselan

In February 2023, GlycoMimetics announced that the independent Data Monitoring Committee for its ongoing Phase 3 trial of uproleselan in R/R AML had conducted an interim utility analysis (IA) and subsequently recommended the study should continue to the originally planned final overall survival events trigger. A statistical plan to add an IA to the Phase 3 study was cleared with the FDA in the fourth quarter of 2022, which enabled the DMC to review efficacy data from that study at around 80% of planned survival events. The IA utilized a very conservative threshold to preserve the statistical integrity of the originally planned final overall survival analysis. The overall survival events trigger is projected to occur within the first half of 2024.
The NCI Alliance for Clinical Trials in Oncology will conduct a planned interim analysis of event-free survival in 267 patients randomized to its Phase 2/3 clinical trial evaluating uproleselan in newly diagnosed older adults with AML who are fit for chemotherapy. When available, the company will share these interim analysis results.
First Quarter 2023 Financial Results:

Cash position: As of March 31, 2023, GlycoMimetics had cash and cash equivalents of $65.0 million as compared to $47.9 million as of December 31, 2022. During the quarter the Company raised $28.7 million dollars from sales of shares of common stock under its existing ATM facility.
R&D Expenses: The Company’s research and development expenses decreased to $5.4 million for the quarter ended March 31, 2023, as compared to $9.6 million for the same period in 2022. The decreased expenses were primarily due to lower clinical trial and development costs related to our global Phase 3 clinical trial of uproleselan in individuals with relapsed/refractory AML, which completed enrollment in November 2021.
G&A Expenses: The Company’s general and administrative expenses increased to $5.5 million for the quarter ended March 31, 2023, as compared to $5.1 million for the same period in 2022, primarily due to commercial readiness expenses for uproleselan and additional patent fees.
Shares Outstanding: Shares of common stock outstanding as of March 31, 2023, were 64,245,224.
The Company will host a conference call and webcast today at 8:30 a.m. ET. To access the call by phone, please go to this registration link and you will be provided with dial in details. Participants are encouraged to connect 15 minutes in advance of the scheduled start time.

A live webcast of the call will be available on the "Investors" tab on the GlycoMimetics website. A webcast replay will be available for 30 days following the call.

About Uproleselan

Discovered and developed by GlycoMimetics, uproleselan is an investigational first-in-class, E-selectin antagonist. Uproleselan (yoo’ pro le’se lan), currently in a comprehensive Phase 3 development program in acute myeloid leukemia (AML), has received Breakthrough Therapy designation from the U.S. FDA and from the Chinese National Medical Products Administration for the treatment of adult AML patients with relapsed or refractory disease. Uproleselan is designed to block E-selectin binding and stimulation of myeloid cells. E-selectin is expressed on the surface of blood vessels, and its binding to myeloid cells confers a pro-survival effect. Uproleselan intends to provide a novel approach to disrupting established mechanisms of leukemic cell resistance.

On May 3, 2023 G1 Therapeutics, Inc. (Nasdaq: GTHX), a commercial-stage oncology company, reported a corporate and financial update for the first quarter ended March 31, 2023 (Press release, G1 Therapeutics, MAY 3, 2023, View Source [SID1234630914]).

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"Since the start of 2023, we’ve focused efforts on our three core priorities of driving significant growth in sales of COSELA, executing on our four ongoing clinical trials of trilaciclib, and efficiently managing our cash runway through each of our data readouts," said Jack Bailey, Chief Executive Officer of G1 Therapeutics. "We made good progress on all fronts during the first quarter of this year. The commercial team executed well, driving net COSELA sales growth of 18% quarter-over-quarter, and vial volume growth of 21%, as we work towards our guidance of between $50 million and $60 million in product revenue this year. Regarding the clinical pipeline, we’ve continued to move each of our trials forward, including our two Phase 2 trials in TNBC from which data are expected later this quarter, followed by results from our pivotal Phase 3 trial in TNBC which are now expected in the first quarter of next year."

First Quarter 2023 and Recent Highlights

Financial

Recognized $10.5 million in Net COSELA Revenue: Results represent an 18% increase in net sales over the fourth quarter of 2022. G1 recognized total revenues of $12.9 million for the first quarter of 2023.

Achieved 21% COSELA Vial Volume Growth Over the Fourth Quarter of 2022.

Ended the First Quarter 2023 with Cash, Cash Equivalents, and Marketable Securities of $116.3 million.

Strengthened Balance Sheet Through Non-Equity Dilutive Monetization of Simcere Milestones and Royalties: In the second quarter of 2023, G1 and Simcere reached agreement whereby Simcere will buy out the remaining milestones and royalties on sales of COSELA (trilaciclib hydrochloride for injection) in Greater China for up to $48 million, with $30 million received within the second quarter of 2023, providing additional non-equity dilutive financing that secures G1’s cash runway beyond its clinical trial readouts. All other aspects of the strategic collaboration remain in place including participation and cost-sharing in global clinical trials. G1 retains the rights to trilaciclib throughout the rest of the world, other than Greater China.
Clinical

Provided Updated Timing for Initial Results from Pivotal Phase 3 Clinical Trial of Trilaciclib in Patients with mTNBC; Interim OS Analysis Now Expected in the First Quarter of 2024: The primary endpoint of PRESERVE 2 is to evaluate the effect of trilaciclib on OS compared with placebo in patients receiving first-line gemcitabine/carboplatin. G1 now expects the interim OS analysis to be conducted by its data monitoring committee at 70% of events in the first quarter 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.

Completed Enrollment in Phase 2 Trial of Trilaciclib in Combination with the ADC Sacituzumab Govitecan-Hziy: Enrollment is complete at 30 patients in this exploratory Phase 2, multicenter, open-label, single arm study evaluating the safety and efficacy of trilaciclib administered prior to sacituzumab in patients with unresectable, locally advanced or metastatic TNBC.

Announced Upcoming Poster Presentation of Results from Trilaciclib Phase 2 ADC Combination Trial: Additional results from this trial in metastatic TNBC have been accepted for poster presentation during the European Society for Medical Oncology (ESMO) (Free ESMO Whitepaper) Breast Cancer 2023 Annual Congress. The abstract (201P) will be presented during the poster session on May 12, 2023 from 12:15PM to 1:00PM Central European Summer Time (CEST). G1 currently expects to reach the OS endpoints for this study in the first quarter of 2024. Initial Phase 2 safety data presented in November 2022 suggested an on-target effect of trilaciclib to reduce the rates of adverse events associated with sacituzumab govitecan (SG), including myelosuppression and diarrhea, relative to the previously published SG single agent safety profile. (Press release here)

Announced Upcoming Poster Presentation of Results from Phase 2 Mechanism of Action Trial of Trilaciclib in Patients with Neoadjuvant TNBC: Additional results from this trial have been accepted for poster presentation during the American Society of Clinical Oncology (ASCO) (Free ASCO Whitepaper) 2023 Annual Meeting. The abstract (603) will be presented during the poster session on June 4, 2023 from 8:00AM to 11:00AM CDT. Initial Phase 2 safety data showed 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)

Confirmed that Initial Results Including the Primary Endpoint of Progression Free Survival from the 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. The Company currently expects to reach the OS endpoints for this study in the first quarter of 2024.
First Quarter 2023 Financial Results

As of March 31, 2023, cash and cash equivalents and marketable securities totaled $116.3 million, compared to $145.1 million as of December 31, 2022. 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 first quarter of 2023 were $12.9 million, including $10.5 million in net product sales of COSELA and license revenue of $2.5 million, related to supply and manufacturing services with Simcere, royalty revenue from Simcere, and clinical trial reimbursements from EQRx and Simcere, compared to $6.9 million in total revenues in the first quarter of 2022.

Operating expenses for the first quarter of 2023 were $38.7 million, compared to $53.7 million for the first quarter of 2022. GAAP operating expenses include stock-based compensation expense of $3.8 million for the first quarter of 2023, compared to $5.8 million for the first quarter of 2022.

Cost of goods sold expense for the first quarter of 2023 was $1.5 million compared to $0.7 million for the first quarter of 2022, primarily due to an increase in product sales.

Research and development (R&D) expenses for the first quarter of 2023 were $15.5 million, compared to $26.3 million for the first quarter of 2022. The decrease in R&D expenses was primarily due to a decrease in the Company’s clinical program costs.

Selling, general, and administrative (SG&A) expenses for the first quarter of 2023 were $21.8 million, compared to $26.7 million for the first quarter of 2022. The decrease in SG&A expenses was primarily due to decreases in commercialization activities, personnel costs, and professional fees.

The net loss for the first quarter of 2023 was $27.6 million, compared to $49.2 million for the first quarter of 2022. The basic and diluted net loss per share for the first quarter of 2023 was $(0.53) compared to $(1.15) for the first quarter of 2022.

2023 Financial Guidance

G1 today reiterated its full year 2023 net revenue guidance. The Company expects to generate between $50 million and $60 million in COSELA net revenue in 2023. G1’s product revenue guidance was initially provided in its fourth quarter and full year 2022 financial results and business update, and 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 first quarter ended March 31, 2023.

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.

On May 3, 2023 Fate Therapeutics, Inc. (NASDAQ: FATE), a clinical-stage biopharmaceutical company dedicated to bringing a first-in-class pipeline of induced pluripotent stem cell (iPSC)-derived cellular immunotherapies to patients with cancer and autoimmune disorders, reported business highlights and financial results for the first quarter ended March 31, 2023 (Press release, Fate Therapeutics, MAY 3, 2023, View Source [SID1234630913]).

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"Over the first months of 2023, we have sharpened our clinical focus and significantly reduced our operating expenses, creating the necessary cash runway to achieve key milestones across our multiplexed-engineered CAR NK and CAR T-cell pipeline. We sincerely thank our employees whose patience and perseverance have allowed us to emerge through this transition period with a renewed sense of energy, commitment, and drive to bring first-in-class, iPSC-derived cellular immunotherapies to patients with cancer and autoimmune disorders," said Scott Wolchko, President and Chief Executive Officer of Fate Therapeutics. "We are now well-positioned to clinically assess higher therapeutic exposures for our FT576 BCMA-targeted CAR NK cell program in multiple myeloma and our FT819 CD19-targeted CAR T-cell program in B-cell malignancies. In addition, we aim to bring our FT522 CD19-targeted CAR NK cell program, which incorporates our proprietary ADR technology designed to enhance NK cell potency, extend functional persistence, and resist host immune cell rejection, into clinical development in the second half of 2023 for B-cell lymphoma, and intend to expand its clinical reach to include severe autoimmune disorders. Finally, we are excited to be jointly developing our clinical strategy with ONO Pharmaceutical for FT825/ONO-8250, our HER2-targeted CAR T-cell collaboration program for solid tumors for which we plan to submit an IND application in the second half of 2023."

NK Cell Programs

FT576 BCMA-targeted CAR NK Cell Program Accruing Patients in Multi-dose Escalation Cohorts for Multiple Myeloma. The Company’s Phase 1 study of FT576, its multiplexed-engineered, BCMA-targeted chimeric antigen receptor (CAR) NK cell product candidate for relapsed / refractory multiple myeloma, is currently enrolling two-dose treatment cohorts as monotherapy and in combination with CD38-targeted monoclonal antibody (mAb) therapy at 300 million cells per dose. Upon clearance of the current treatment cohorts, the Company plans to open and assess three-dose treatment cohorts starting at 1 billion cells per dose. At the 2022 American Society of Hematology (ASH) (Free ASH Whitepaper) Annual Meeting in December, the Company presented interim Phase 1 clinical data from nine heavily pre-treated patients in the single-dose cohorts, which showed encouraging clinical evidence of BCMA-targeted activity and a favorable safety profile indicating the potential for administration in the outpatient setting. Translational data from the CD38-targeted mAb combination regimen showed rapid and selective depletion of CD38-positive patient immune cells in the peripheral blood and bone marrow that extended through the first month of therapy, indicating that the regimen may uniquely serve to attenuate reconstitution of activated T cells, extend functional persistence of FT576, and enable dual-antigen targeting of myeloma cells.

Initiation of Clinical Assessment of FT522 ADR-armed, CD19-targeted CAR NK Cell Program Anticipated in 2H23. FT522 is the Company’s first product candidate to incorporate its proprietary alloimmune defense receptor (ADR) technology, which has been shown in preclinical studies to increase NK cell potency, enhance functional persistence, and confer resistance to host immune cell allo-reactivity. The Company has recently submitted an Investigational New Drug (IND) application to the U.S. Food and Drug Administration (FDA) to investigate the safety and activity of FT522 in combination with CD20-targeted mAb therapy in patients with B-cell lymphoma, including without prior administration of intensive conditioning chemotherapy. In addition, the Company is currently conducting preclinical studies to support clinical assessment of FT522 in autoimmune disease, including in combination with CD20- and CD38-targeted mAb therapy, to selectively target and durably deplete pathogenic B cells, plasma cells, and auto-reactive T cells.
T-cell Programs

First-of-kind FT819 Program Advancing in Single-dose Escalation Cohorts for B-cell Malignancies. The Company’s landmark Phase 1 clinical trial of FT819, which is the first-ever clinical investigation of a T-cell product candidate manufactured from a clonal master iPSC line, is currently enrolling patients in single-dose escalation cohorts at 540 million cells in B-cell lymphoma and at 180 million cells in chronic lymphocytic leukemia. At the 2022 ASH (Free ASH Whitepaper) Annual Meeting, the Company presented interim Phase 1 clinical data from eight patients with relapsed / refractory aggressive large B-cell lymphoma treated with a single dose of FT819 ranging from 90 million cells to 360 million cells, which demonstrated a favorable safety profile and objective responses including in patients who were not eligible for or had previously failed autologous CD19-targeted CAR T-cell therapy. FT819 incorporates several novel features including the integration of a novel CD19-targeted 1XX CAR construct into the T-cell receptor alpha constant (TRAC) locus, which is intended to promote uniform CAR expression, enhance T-cell potency, and prevent graft-versus-host disease.

2023 IND Submission Planned for HER2-targeted CAR T-cell Program for Solid Tumors. Under the Company’s collaboration with ONO Pharmaceutical Co., Ltd. (ONO), the companies are co-developing FT825/ONO-8250, an iPSC-derived CAR T-cell product candidate targeting human epidermal growth factor receptor 2 (HER2)-expressing solid tumors. IND-enabling activities for FT825/ONO-8250 are currently ongoing, and the Company plans to submit an IND application to the FDA in 2023 to jointly conduct with ONO a Phase 1 study for the treatment of patients with HER2-positive solid tumors. The multiplexed-engineered, iPSC-derived CAR T-cell product candidate incorporates seven novel synthetic controls designed to enhance effector cell function and overcome unique challenges in treating solid tumors, including a novel HER2-targeted binding domain with a differentiated targeting profile, a synthetic CXCR2 receptor to promote cell trafficking, a synthetic TGFβ receptor to redirect immunosuppressive signals in the tumor microenvironment, and a synthetic interleukin-7 receptor fusion protein to induce T-cell activation.

Strategic Pipeline Prioritization & Corporate Restructuring
During the first quarter of 2023, in connection with the termination of its collaboration with Janssen Biotech, Inc. (Janssen), the Company discontinued all collaboration activities, including withdrawing an IND application previously allowed by the FDA for a first collaboration product for the treatment of B-cell lymphoma. In addition, following a strategic review of its wholly-owned iPSC-derived NK cell and T-cell programs, the Company focused its operations on advancing its most innovative and differentiated programs and initiated the discontinuation of its FT516, FT596, FT538, and FT536 NK cell product candidates. As part of its corporate restructuring, the Company reduced its workforce to approximately 220 employees.

First Quarter 2023 Financial Results & 2023 Guidance

Cash & Investment Position: Cash, cash equivalents and investments as of March 31, 2023 were $412.8 million. In addition, as of March 31, 2023, cash receivables from collaborations were $13.5 million. The Company expects its cash, cash equivalents, and investments to exceed $300 million at year-end 2023.
Total Revenue: Revenue was $59.0 million for the first quarter of 2023, of which $52.3 million was associated with the termination of its collaboration with Janssen and $6.7 million was derived from its ongoing collaboration with ONO. Under the ONO collaboration, a one-time amount of $6.2 million was recorded as revenue for the first quarter of 2023 associated with the Company’s conduct of IND-enabling activities for FT825/ONO-8250, for which ONO exercised its development and commercialization option in November 2022. For each of the remaining three quarters of 2023, the Company expects to recognize approximately $0.8 million in revenue under the ONO collaboration in connection with its conduct of preclinical development activities for a second collaboration candidate targeting an undisclosed solid tumor antigen.
Total Operating Expenses: For the first quarter of 2023, GAAP operating expenses were $87.6 million, including research and development expenses of $65.6 million and general and administrative expenses of $21.9 million. Such amounts included $11.0 million of non-cash stock-based compensation expense and a one-time charge of $12.9 million for severance and other employee termination-related costs associated with the Company’s corporate restructuring. For the full year ending December 31, 2023, the Company expects its GAAP operating expenses to be between $265 million to $285 million.
Shares Outstanding: Common shares outstanding were 98.2 million, and preferred shares outstanding were 2.8 million, as of March 31, 2023. Each preferred share is convertible into five common shares.

Today’s Conference Call and Webcast

The Company will conduct a conference call today, Wednesday, May 3, 2023 at 5:00 p.m. ET to review financial and operating results for the quarter ended March 31, 2023. In order to participate in the conference call, please register using the conference link here. The live webcast can be accessed under "Events & Presentations" in the Investors section of the Company’s website at www.fatetherapeutics.com. The archived webcast will be available on the Company’s website beginning approximately two hours after the event.