On August 8, 2023 Heidelberg Pharma AG (FSE: HPHA) reported that its partner Takeda reached a development milestone for starting a GLP (Good Laboratory Practice) toxicology study for an Antibody Targeted Amanitin Conjugate (Press release, Heidelberg Pharma, AUG 8, 2023, View Source [SID1234633972]). Upon achievement of the milestone, Heidelberg Pharma received a milestone payment. The payment was already budgeted for in Heidelberg Pharma’s financial forecast for financial year 2023.

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Prof. Andreas Pahl, CSO of Heidelberg Pharma AG, commented: "We are happy that the development of Takeda’s ATAC candidate, an Amanitin-based ADC, is progressing successfully and that the important GLP study was started. We are looking forward to the next development steps."

In 2022, Takeda exclusively licensed the worldwide development and commercialization rights from Heidelberg Pharma for the use of the ATAC technology with an antibody directed to a defined target and the resulting product candidates.

About Heidelberg Pharma’s proprietary ATAC technology

Antibody drug conjugates (ADCs) combine the high affinity and specificity of antibodies with the potency of cytotoxic small molecules for the treatment of cancer. Heidelberg Pharma works with ADCs based on its proprietary ATAC technology using Amanitin as the active ingredient. Amanitin belongs to the amatoxin molecules, bicyclic peptides that occur naturally in the green deathcap mushroom. Amanitin inhibits mRNA transcription by binding to RNA polymerase II, a mechanism that is crucial for the survival of eukaryotic cells. Inhibition of RNA polymerase II is a new mode of action for cancer therapy. In preclinical testing, ATACs have been shown to be highly efficacious, overcoming frequently encountered resistance mechanisms and combating even quiescent tumor cells.

On August 8, 2023 Halozyme Therapeutics, Inc. (NASDAQ: HALO) ("Halozyme" or the "Company") reported its financial and operating results for the second quarter ended June 30, 2023 and provided an update on its recent corporate activities and outlook (Press release, Halozyme, AUG 8, 2023, View Source [SID1234633971]).

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"Our strong second quarter results with record revenue of $221 million and non-GAAP EPS of $0.74 were complemented with significant commercial and clinical advancements with our ENHANZE product pipeline," said Dr. Helen Torley, president and chief executive officer of Halozyme. "The FDA approval for argenx’s VYVGART Hytrulo with ENHANZE for generalized myasthenia gravis expanded our commercialized partnered products to six products generating royalty revenue. In addition, argenx’s VYVGART Hytrulo achieved positive data in a second indication for CIDP and Roche’s SC ocrelizumab with ENHANZE met the phase 3 study primary and secondary endpoints, which support the near-term additional opportunities for growth. We expect our commercialized partnered products to further expand with the potential FDA approval of Roche’s SC atezolizumab later this year. We also look forward to late-stage clinical data from argenx for ITP and pemphigus, which will support our future growth trajectory. We are well positioned for another record year with our updated guidance."

Recent Partner Highlights:
•In July 2023, argenx reported positive data from the ADHERE study evaluating VYVGART Hytrulo with ENHANZE in adults with chronic inflammatory demyelinating polyneuropathy ("CIDP"). The study met its primary endpoint resulting in a 61% reduction in risk of relapse compared to placebo.
•In July 2023, Roche announced that the Phase III OCARINA II trial evaluating OCREVUS (ocrelizumab) with ENHANZE as a twice a year 10-minute subcutaneous injection met its primary and secondary endpoints in patients with relapsing forms of multiple sclerosis ("MS") or primary progressive MS ("RMS" or "PPMS").
•In June 2023, argenx received U.S. Food and Drug Administration ("FDA") approval for VYVGART Hytrulo injection with ENHANZE for SC use for the treatment of generalized myasthenia gravis in adult patients who are anti-acetylcholine receptor ("AChR") antibody

positive and in July 2023, VYVGART Hytrulo was made available to patients, triggering $33.0 million in milestone payments and the right to receive royalties on net product sales.
•In June 2023, Takeda announced positive results from a pivotal Phase 3 trial evaluating HYQVIA for maintenance treatment of chronic inflammatory demyelinating polyneuropathy ("CIDP") and confirmed regulatory applications were under review in the U.S. and European Union.
•In April 2023, Takeda announced that the FDA approved a supplemental Biologics License Application ("sBLA") to expand the use of HYQVIA to treat primary immunodeficiency in children.

Second Quarter 2023 Financial Highlights:
•Revenue in the second quarter was $221.0 million compared to $152.4 million in the second quarter of 2022. The 45% year-over-year increase was driven by growth in ENHANZE revenue streams with an increase in royalty revenue and an increase in milestone revenue due to the approval and launch of VYVGART Hytrulo as well as the addition of product sales as a result of the Antares Pharma acquisition. Revenue for the quarter included $111.7 million in royalties, an increase of 31% compared to $85.3 million in the prior year period, primarily attributable to subcutaneous DARZALEX (daratumumab).
•Cost of sales in the second quarter was $50.1 million, compared to $33.9 million in the second quarter of 2022. The increase was driven by an increase in product sales as a result of the Antares Pharma acquisition and amortization of inventory step-up associated with purchase accounting for the Antares Pharma acquisition.
•Amortization of intangibles expense in the second quarter was $17.8 million, due to the Antares Pharma acquisition, in which Halozyme acquired intangible assets that are amortized over a useful life related to the auto injector technology platform, XYOSTED and TLANDO.
•Research and development expense in the second quarter was $19.7 million, compared to $15.5 million in the second quarter of 2022. The increase is primarily due to an increase in compensation expense related to the ongoing combined larger workforce as a result of the Antares Pharma acquisition, which added device platform resources in regulatory, quality and manufacturing, as well as planned investments in ENHANZE.
•Selling, general and administrative expense in the second quarter was $38.9 million, compared to $57.5 million in the second quarter of 2022. The decrease was primarily due to one-time transaction costs in the prior year, partially offset by an increase in compensation expense related to the ongoing combined larger workforce, including the addition of commercial resources in sales and marketing for the testosterone replacement therapy products.
•Operating income in the second quarter was $94.5 million, compared to operating income of $34.1 million in the second quarter of 2022. Net Income in the second quarter was $74.8 million, compared with net income of $22.7 million in the second quarter of 2022. EBITDA in the second quarter was $115.1 million, compared with EBITDA of $46.6 million in the second quarter of 2022. Adjusted EBITDA in the second quarter was $115.1 million, compared with Adjusted EBITDA of $87.8 million in the second quarter of 2022.
•Earnings per Share: On a GAAP basis in the second quarter of 2023, diluted earnings per share was $0.56, compared with $0.16 in the second quarter of 2022. On a non-GAAP basis, diluted earnings per share was $0.74, compared with diluted earnings per share of $0.53 in the second quarter of 2022.1
•Cash, cash equivalents and marketable securities were $348.3 million on June 30, 2023, compared to $362.8 million on December 31, 2022. The decrease was primarily due to the repurchase of common stock for $150.0 million in the first quarter of 2023.

Financial Outlook for 2023

The Company is increasing the lower end of revenue and EBITDA guidance ranges to reflect strong second quarter results. In addition, the Company is increasing non-GAAP diluted earnings per share guidance to reflect the impact of share repurchases that occurred earlier in the year. For the full year 2023, the Company now expects:

•Total revenue of $825 million to $845 million, representing growth of 25% to 28% over 2022 total revenue primarily driven by continued strength in Wave 2 products, including DARZALEX SC (daratumumab) and Phesgo (pertuzumab, trastuzumab and hyaluronidase) utilizing ENHANZE, as well as full year auto-injector royalty and product contribution. The Company expects revenue from royalties of $445 million to $455 million, representing growth of 23% to 26%.
•EBITDA of $420 million to $440 million, representing growth of >30% over 2022. EBITDA excludes the impact of amortization costs related to the Antares Pharma acquisition.1
•Non-GAAP diluted earnings per share of $2.65 to $2.75, representing growth of 20% over 20221. The Company’s earnings per share guidance does not consider the impact of potential future share repurchases.

On August 8, 2023 Gossamer Bio, Inc. (Nasdaq: GOSS), a clinical-stage biopharmaceutical company focused on the development and commercialization of seralutinib for the treatment of pulmonary arterial hypertension (PAH), reported its financial results for the second quarter ended June 30, 2023 and provided a business update (Press release, Gossamer Bio, AUG 8, 2023, View Source [SID1234633970]).

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"We are very excited to begin the Phase 3 PROSERA Study, the next step on our journey to make seralutinib available to patients with PAH," said Faheem Hasnain, Chairman, Co-Founder and CEO of Gossamer Bio. "Seralutinib, as a potentially disease-modifying therapy delivered via convenient dry powder inhaler, has the chance to fundamentally alter the treatment paradigm for this progressive disease. I am so proud of our team’s efforts thus far and share in the enthusiasm for the work ahead."

Seralutinib (GB002): Inhaled PDGFR, CSF1R and c-KIT Inhibitor for PAH

•In July, Gossamer announced an interim update of its Phase 2 TORREY Study open-label extension (OLE) data and details of the design of the Phase 3 PROSERA Study. A webcast was held on July 25th to discuss this information with global PAH leaders Dr. Ray Benza, Dr. Ardi Ghofrani, and Dr. Jim White. A recording of this webcast is available at View Source
•The Phase 3 PROSERA Study in Functional Class II and III PAH patients is expected to initiate in the third quarter of 2023. The primary endpoint is change in six-minute walk distance (6MWD) from baseline at week 24.
•Gossamer expects to release further TORREY OLE data from the ongoing extension study in PAH patients in the fourth quarter of 2023 or the first quarter of 2024.

Corporate Updates

• On July 20, the Company announced the sale of 129,869,440 shares of its common stock and accompanying warrants to purchase up to 32,467,360 shares of common stock to new and existing institutional investors and certain directors and executive officers of Gossamer in a private placement, raising approximately $212 million in gross proceeds.

Financial Results for Quarter Ended June 30, 2023

•Cash, Cash Equivalents and Marketable Securities: Cash, cash equivalents and marketable securities as of June 30, 2023, were $162.1 million. The Company expects the combination of current cash, cash equivalents and marketable securities, inclusive of the proceeds from the July private placement, will be sufficient to fund its operating and capital expenditures into the first half of 2026.
•Research and Development (R&D) Expenses: For the quarter ended June 30, 2023, R&D expenses were $36.3 million, compared to $42.6 million for the same period in 2022, for a decrease of $6.3 million, which was primarily attributable to a decrease of $9.5 million of costs associated with preclinical studies and clinical trials for other programs and a decrease of $5.7 million of costs associated with preclinical studies and clinical trials for GB5121, offset by an increase of $8.9 million of costs associated with preclinical studies and clinical trials for seralutinib.
•General and Administrative (G&A) Expenses: For the quarter ended June 30, 2023, G&A expenses were $10.0 million, compared to $11.3 million for the same period in 2022.
•Net Loss: Net loss for the quarter ended June 30, 2023, was $42.5 million, or $0.45 per share, compared to a net loss of $56.5 million, or $0.74 per share, for the same period in 2022.

On August 8, 2023 Fusion Pharmaceuticals Inc. (Nasdaq: FUSN), a clinical-stage oncology company focused on developing next-generation radiopharmaceuticals as precision medicines, reported financial results for the second quarter ended June 30, 2023 and provided an update on clinical and corporate developments (Press release, Fusion Pharmaceuticals, AUG 8, 2023, View Source [SID1234633969]).

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Chief Executive Officer John Valliant, Ph.D. commented, "In the second quarter, we achieved progress across our clinical pipeline of targeted alpha therapies (TATs). Patient enrollment is ongoing for the Phase 2 clinical trial of FPI-2265, a small molecule-based TAT targeting prostate specific membrane antigen (PSMA) for the treatment of metastatic castration-resistant prostate cancer (mCRPC), and we are on track to report data in the first quarter of 2024. Patient enrollment is also ongoing in the Phase 1 study of FPI-2059 targeting neurotensin receptor 1 (NTSR1). Additionally, the U.S. Food and Drug Administration (FDA) cleared the Investigational New Drug (IND) application for FPI-2068, a bispecific TAT jointly developed with AstraZeneca for the treatment of various solid tumors that express EGFR-cMET.

Dr. Valliant continued, "We are encouraged by the interim safety, dosimetry and PK data from the dose escalation portion of the Phase 1 trial of FPI-1434 in patients with solid tumors expressing IGF-1R presented at the Society for Nuclear Medicine and Molecular Imaging (SNMMI) Annual Meeting in June. These data showed pre-administration of cold antibody has the potential to significantly enhance the therapeutic index by driving more active drug to tumor sites with an improved safety profile compared to hot-only dosing, reinforcing our belief that targeted alpha therapies (TATs) could be next generation antibody drug conjugates (ADCs) for a broad array of tumor types in areas of high unmet medical need. We are evaluating the cold/hot regimen at the next dose level in Cohort 2 and look forward to sharing data around the end of this year."

Portfolio Update

FPI-2265

In February 2023, Fusion acquired an investigational new drug application (IND) for an ongoing Phase 2 clinical trial (the "TATCIST" trial) evaluating 225Ac-PSMA I&T, a small molecule targeting PSMA expressed in prostate cancers. Following completion of the acquisition from RadioMedix, the IND was transferred to Fusion. The alpha-emitting radiopharmaceutical being evaluated in the TATCIST trial is now known as FPI-2265.

The TATCIST trial is designed to evaluate patients with mCRPC with progressive disease, including patients who are naïve to PSMA-targeted radiopharmaceuticals and those who have been pre-treated with 177Lu-based PSMA radiopharmaceuticals such as PLUVICTO. Fusion expects to report data on approximately 20 to 30 patients in the first quarter of 2024.

FPI-1434

The Phase 1, multi-center, open-label clinical trial is designed to investigate the safety, tolerability and pharmacokinetics of FPI-1434 in patients with solid tumors expressing IGF-1R. The trial is also designed to establish the maximum tolerated dose for FPI-1434 and the recommended Phase 2 dose. As part of the precision medicine approach, prior to receiving the therapeutic injection of FPI-1434, patients are administered an indium-111 imaging analogue, [111In]-FPI-1547 (FPI-1547). The images collected are used to confirm the presence of tumor uptake and ensure that estimated radiation doses to organs and tissues are below protocol-specified safety limits.

Following results from an imaging sub-study evaluating pre-administration of cold antibody prior to each dose of FPI-1547 that demonstrated a favorable gain in tumor lesion uptake versus normal tissue, the Company amended the Phase 1 trial protocol to evaluate both the hot only and cold/hot dosing regimens. Interim Phase 1 data were presented at the SNMMI Annual Meeting in June 2023. Three patients were dosed in Cohort 1 at a dose of 15 kBq/kg following pre-administration of cold antibody. In this first cohort, cold/hot dosing was observed to be safe with no treatment-related serious adverse events (SAEs) or dose limiting toxicities (DLTs). Results demonstrated pre-administration of cold antibody improved tumor uptake while also reducing hematological toxicity observed in the hot only dosing arm, potentially enhancing the therapeutic index. When normalized to 15 kBq/kg, the average lesion absorbed dose and dose/volume in the cold/hot arm were nearly double the level compared to hot only. Further, the 15 kBq/kg cold/hot dosing arm showed comparable systemic exposure to approximately 40 kBq/kg of a hot only dose but with an improved hematological profile as measured by changes in platelet count. Based on these results, Fusion has discontinued the hot-only dosing portion of the study and is currently enrolling Cohort 2 in the cold/hot dosing regimen at 25 kBq/kg. The Company expects to report data from this cohort around year-end 2023.

FPI-2059

The Phase 1, multi-center, open-label clinical trial is designed to investigate the safety, tolerability, dosimetry, biodistribution, and pharmacokinetics of FPI-2059 as well as preliminary anti-tumor activity in participants with NTSR1 expressing advanced metastatic solid tumors. Patient enrollment and dosing are ongoing. Fusion plans to provide guidance on timing for pharmacokinetic, imaging and safety data following early experience with FPI-2059 patient screening and enrollment.

FPI-2068

In April 2023, Fusion announced FDA clearance of IND applications for [225Ac]-FPI-2068 (FPI-2068) and corresponding imaging analogue [111In]-FPI-2107 (FPI-2107). Fusion is jointly developing FPI-2068 with AstraZeneca under the companies’ multi-asset collaboration agreement. FPI-2068 is a bispecific TAT designed to deliver actinium-225 to various solid tumors that express EGFR-cMET. EGFR and cMET are both validated targets that are co-expressed in multiple tumor types, including head and neck squamous cell carcinoma, non-small cell lung cancer, colorectal cancer, and pancreatic ductal adenocarcinoma. Fusion plans to provide additional guidance on timelines for the FPI-2068 program following initial experience with patient screening to better predict the cadence of patient enrollment.

Recent News

•
In June, Fusion presented at SNMMI interim data from the Phase 1 Trial of FPI-1434 in patients with solid tumors expressing IGF-1R.
•
In May, Fusion announced the opening of its state-of-the-art radiopharmaceutical manufacturing facility. The 27,000 square foot good manufacturing practice (GMP) compliant facility, which is located adjacent to the Company’s research and development labs, has clinical and commercial manufacturing scale capabilities designed to support the Company’s growing pipeline of targeted alpha therapies (TATs). The facility is expected to be fully operational in 2024.
•
In April, Fusion announced the clearance of IND applications for FPI-2068 and corresponding imaging analogue FPI-2107 to the FDA.
Second Quarter 2023 Financial Results

•
Cash and Investments: As of June 30, 2023, Fusion held cash, cash equivalents and investments of $226.5 million, compared to cash, cash equivalents and investments of $186.6 million as of December 31, 2022. Fusion expects its existing cash, cash equivalents and investments as of June 30, 2023 will be sufficient to fund operations into the second quarter of 2025.
•
Collaboration Revenue: For the second quarter of 2023, Fusion recorded less than $0.1 million of revenue under the AstraZeneca collaboration agreement, compared to $0.6 million for the same period in 2022.
•
R&D Expenses: Research and development expenses for the second quarter of 2023 were $19.0 million, compared to $12.1 million for the same period in 2022. The increase was primarily due to costs associated with the Phase 2 clinical trial of FPI-2265, as well as the wind down of FPI-1966 program-related activities and study close out costs, and an increase in personnel-related costs.
•
G&A Expenses: General and administrative expenses for the second quarter of 2023 and 2022 each were $7.8 million.
•
Net Loss: For the second quarter of 2023, Fusion reported a net loss of $25.2 million, or $0.38 per share, compared with a net loss of $19.1 million, or $0.44 per share, for the same period in 2022.

On August 8, 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 second quarter ended June 30, 2023 (Press release, Fate Therapeutics, AUG 8, 2023, View Source [SID1234633968]).

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"We have shown great resilience in advancing our most innovative and differentiated programs while reducing expenses during the first six months of 2023, creating an operating runway into the second half of 2025 that enables us to achieve key milestones across our pipeline," said Scott Wolchko, President and Chief Executive Officer of Fate Therapeutics. "We have commenced Phase 1 study start-up activities for our FT522 ADR-armed, CD19-targeted CAR NK cell program for B-cell lymphoma, where we intend to assess FT522 with and without administration of conditioning chemotherapy to patients. We have also initiated GMP manufacturing of FT825/ONO-8250 under our solid tumor collaboration with ONO Pharmaceutical, and plan to submit an IND application in the second half of 2023 for this multiplexed-engineered, HER2-targeted CAR T-cell program. Finally, we continue to preclinically assess the potential of our off-the-shelf, iPSC-derived cellular immunotherapies to selectively target and durably deplete pathogenic immune cells, and are evaluating opportunities for clinical expansion into autoimmunity."

NK Cell Programs

Phase 1 Start-up Ongoing for FT522 ADR-armed, CD19-targeted CAR NK Cell Program. FT522 is the Company’s off-the-shelf, multiplexed-engineered, induced pluripotent stem cell (iPSC)-derived natural killer (NK) cell product candidate that incorporates five synthetic controls of cell function. It is the Company’s first product candidate armed with its proprietary alloimmune defense receptor (ADR) technology, which is comprised of a synthetic engineered receptor targeting 4-1BB and is designed to promote anti-tumor activity without requiring administration of intensive conditioning chemotherapy to patients. In May, the U.S. Food and Drug Administration (FDA) allowed the Company’s Investigational New Drug (IND) application for the clinical investigation of FT522 in combination with CD20-targeted monoclonal antibody (mAb) therapy in patients with relapsed / refractory B-cell lymphoma. The dose-escalation stage of the study is designed to assess the safety and activity of FT522 with and without administration of intensive conditioning chemotherapy to patients. The Company is conducting Phase 1 study start-up activities at multiple sites, and plans to initiate patient enrollment with a three-dose treatment schedule at 300 million cells per dose. The Company is also currently evaluating in preclinical studies the potential of FT522 to induce an immunologic reset in patients with autoimmune disorders by selectively targeting and durably depleting pathogenic immune cells, including disease-causing B cells, plasma cells, and auto-reactive T cells.
FT576 BCMA-targeted CAR NK Cell Program Accruing Patients in Three-dose Treatment Cohorts. 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 patients in two, three-dose treatment cohorts at 1 billion cells per dose. The Company has treated the first patient as monotherapy, and has also treated the first patient in combination with CD38-targeted mAb to assess the therapeutic potential of dual-antigen targeting of myeloma cells. Patient enrollment in each of the three-dose treatment cohorts is proceeding independently.
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 is the first-ever clinical investigation of a T-cell product candidate manufactured from a clonal master iPSC line. FT819 incorporates several novel synthetic controls of cell function, 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. The Company is currently enrolling patients in single-dose treatment cohorts at 540 million cells in B-cell lymphoma and at 360 million cells in chronic lymphocytic leukemia.
2H23 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 that incorporates seven novel synthetic controls designed to enhance effector cell function and overcome unique challenges in treating solid tumors. The Company is currently conducting IND-enabling activities and GMP manufacturing of FT825/ONO-8250, and plans to submit an IND application to the FDA in the second half of 2023 to jointly conduct 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 a novel HER2-targeted binding domain with a differentiated activity 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 enhance T-cell function.
Second Quarter 2023 Financial Results

Cash & Investment Position: Cash, cash equivalents and investments as of June 30, 2023 were $385.2 million. In addition, as of June 30, 2023, cash receivables from the Company’s collaboration with ONO were $2.8 million.
Total Revenue: Revenue was $0.9 million for the second quarter of 2023, which was derived from the Company’s conduct of preclinical development activities for a second collaboration candidate targeting an undisclosed solid tumor antigen under its collaboration with ONO.
Total Operating Expenses: For the second quarter of 2023, GAAP operating expenses were $63.5 million, including research and development expenses of $40.9 million and general and administrative expenses of $22.6 million. Such amounts included $12.9 million of non-cash stock-based compensation expense.
Shares Outstanding: Common shares outstanding were 98.5 million, and preferred shares outstanding were 2.8 million, as of June 30, 2023. Each preferred share is convertible into five common shares.
Today’s Conference Call and Webcast
The Company will conduct a conference call today, Tuesday, August 8, 2023 at 5:00 p.m. ET to review financial and operating results for the quarter ended June 30, 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.