BerGenBio Announces Initiation of Phase 2a in First Line Non-Small Lung Cancer Patients with a STK11 mutation

On March 20, 2024 BerGenBio ASA (OSE: BGBIO), a clinical-stage biopharmaceutical company developing novel, selective AXL kinase inhibitors for severe unmet medical needs, reported that it has initiated the Phase 2a portion of the BGBC016 clinical study of its selective AXL inhibitor bemcentinib in combination with standard of care therapy in first-line Non Small Cell Lung Cancer (NSCLC) patients harboring a STK11 mutation (STK11m) (Press release, BerGenBio, MAR 20, 2024, View Source [SID1234641303]).

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The initiation of Phase 2a follows a positive recommendation by the independent Drug Safety Monitoring Board (DSMB) which evaluated the safety of the combination of bemcentinib with pembrolizumab (Keytruda) and doublet chemotherapy in first-line (1L) NSCLC patients enrolled in the Phase 1b portion of the study.

Patients with STK11m NSCLC have a significantly poorer response to current therapies, including immune checkpoint inhibitors, when compared with patients with wild-type (non-mutated) STK11. AXL plays a significant role in the survival and spread of cancer and STK11m NSCLC patients have a high expression of AXL suggesting that AXL is an important target to prevent disease progression and resistance to existing therapies. Bemcentinib’s selective inhibition of AXL has been shown to improve the response to immune checkpoint inhibition in STK11m patient-derived preclinical models and in early clinical studies. There are currently no targeted therapies available for the STK11m NSCLC patient population, which represents up to 20% of 1L NSCLC patients.

Cristina Oliva, Chief Medical Officer of BerGenBio commented, "We are very pleased that no new safety signals have been identified and are encouraged by the recommendation of the DSMB to continue the study as planned. We have therefore, opened the Ph2a portion of the study with the goal of reporting initial efficacy data as the next step in validating the benefit of bemcentinib in combination with standard therapies in 1L NSCLC."

Martin Olin, Chief Executive Officer of BerGenBio added, "The high unmet medical need in 1L STK11m NSCLC patients is widely recognized. Bemcentinib represents a novel treatment modality which may significantly improve the outcome for patients, and we are pleased to have achieved this important milestone."

Innovent Announces 2023 Annual Results and Business Updates

On March 20, 2024 Innovent Biologics, Inc. (Innovent) (HKEX: 01801), a world-class biopharmaceutical company that develops, manufactures and commercializes high-quality medicines for the treatment of cancer, cardiovascular and metabolic, autoimmune, ophthalmology and other major diseases, reported its 2023 annual results and major business updates (Press release, Innovent Biologics, MAR 20, 2024, View Source [SID1234641302]).

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Dr. Michael Yu, Founder, Chairman and CEO of Innovent, stated:"2023 marked a transformative year for Innovent with material progress. We delivered strong revenue growth, improved operational efficiency and financial performance, and enhanced ESG management practices that underline our sustainable business model. Concurrently, we have achieved material innovation progress in both late- and early-stage R&D development, advanced pipeline portfolio across oncology and general biomedicine, and broadened our global pipeline development scope, reinforcing our global innovation strategy. These achievements underscore the dedication to our strategic goals in the second decade – sustainable growth and global innovation. We will continue our high-quality business growth and advance global innovation progress, and create sustainable value for patients, employees, shareholders and society."

Solidified business operations with strong revenue performance and improved financials

Strong revenue growth: total revenue RMB6,206.1 million in the year of 2023, an increase of 36.2% compared with the year of 2022; product sales revenue RMB5,728.3 million in the year of 2023, an increase of 38.4% compared with the prior year, reflecting robust demand for our innovative portfolio and the advantage of our sustainable business model.
Enhanced operational efficiency and financial performance : EBITDA Loss was significantly narrowed, whose key drivers include strong revenue growth, enhanced operational efficiency and remarkable financial improvement.
The selling and marketing expenses of total revenue was 49.3%, a year-over-year decrease of 7.3 percentage points
The administration and expenses of total revenue was 8.8%, a year-over-year decrease of 5.3 percentage points
R&D expenses was RMB1974.9 million; cash and short-term financial assets was RMB10969.6 million, or approximately USD1.5 billion, which enables us to focus on the long-term sustainable development
EBITDA loss was RMB600.1 million, a notable year-over-year decrease of 73.0%
Note: The financial numbers mentioned above were based on non-IFRS measure. Detailed disclosure can be found at the Company’s 2023 annual results announcement.

Solidify oncology leadership; build CVM commercialization capability

Expansion of commercial portfolio into new approved products, new indications and broader NRDL coverage[1],[2] and patient access:
Ten approved products: TYVYT, BYVASDA, SULINNO, HALPRYZA, PEMAZYRE, Olverembatinib, CYRAMZA, Retsevmo, FUCASO (new product, for the treatment of RRMM) and SINTBILO (new product, for the treatment of hypercholesterolemia and mixed dyslipidemia).
All seven approved indications of TYVYT (sintilimab injection) were included in the NRDL. It is also the only PD-1 inhibitor in the NRDL for the treatment of GC and EGFR-mutated NSCLC. As for market expansion, TVYVT (sintilimab injection) was newly approved in the Macau market in February 2024.
Olverembatinib’s first indication was included in the NRDL; and its second indication was newly approved to benefit broader CML patients.
All indications of BYVASDA (bevacizumab injection), HALPRYZA (rituximab injection) and SULINNO (adalimumab injection) were also included in the NRDL.
Oncology and general biomedicines as key growth pillars of the company:
Oncology: we have launched eight products including TYVYT (sintilimab injection), established a mature commercial presence of nearly 3,000 employees, nationwide patient access and a well-recognized brand image. We will continue to solidify leadership and expand business in oncology.
General biomedicine: we have made considerable progress in past years advancing and expanding our pipeline in general biomedicine, including cardiovascular and metabolism (CVM), autoimmune, and ophthalmology, which we believe will result in substantially increased commercial opportunities and diversified long-term growth.
Therefore, as part of the strategic plan, we have been steadily establishing our commercialization capability in the CVM field with systematic approaches. We plan to implement a comprehensive structure and form strategies for key factors, such as patient access, distribution channels, and marketing activities, to ensure all capabilities, personnel and strategies are in place to facilitate effective operations of our business, and to foster long-term brand image and competitive advantage in this new area.
Material innovation progress in both late- and early-stage clinical development

8 assets are in NDA review or pivotal registrational clinical trials, and 18 assets are in early Phase 1/2 clinical studies

Oncology: robust leadership spanning all phases of R&D and novel modalities

Deepened synergies of product portfolio with two target therapies for lung cancer under NDA priority review, which are anticipated to launch in 2024:
IBI344 (ROS1, taletrectinib): 1L and 2L ROS1 positive NSCLC
IBI351 (KRAS G12C, fulzerasib): 2L KRAS G12C mutated NSCLC
Encouraging progress in the next wave innovation of "IO+ADC"
TYVYT (sintilimab): multiple clinical trial collaborations to explore potential of combination therapy with various ADCs for solid tumors
IBI310 (CTLA-4):plan to initiate a Phase 3 clinical trial for IBI310 in combination with sintilimab in treating neoadjuvant colon cancer
IBI343 (CLDN18.2 ADC):preparing for a MRCT Phase 3 clinical trial for IBI343 in 3L GC, subject to regulatory communications; a PoC trial in PDAC is ongoing
Advancing multiple bi-/tri-specific antibodies and ADCs with global potential in early-stage clinical trials
IBI363 (PD-1/IL-2) : preliminary PoC signals in multiple IO resistant/unresponsive cancer types; plan to initiate a Phase 2 clinical trial in the U.S.
Multiple programs ongoing including IBI389(CLDN18.2/CD3), IBI334 (EGFR/B7H3), IBI3003 (GPRC5D/BCMA/CD3), IBI3001(EGFR/B7H3 ADC), IBI130 (TROP2 ADC), IBI133 (HER3 ADC)
CVM : multiple new-generation product candidates achieved substantial R&D milestones

SINTBILO (tafolecimab injection): the first domestic self-developed anti-PCSK9 monoclonal antibody, approved for the treatment of hypercholesteremia and mixed dyslipidemia
Mazdutide (GLP-1R/GCGR): globally the first GLP-1R/GCGR dual agonist in the NDA stage. First NDA of mazdutide was accepted for chronic weight management. Five Phase 3 registrational trials and more clinical trials are underway.
IBI128 (XOI): potential best-in-class XOI for the treatment of hyperuricemia in gout patients. It is undergoing overseas Phase 3 clinical trials conducted by our partner LG Chem. We plan to initiate Phase 1 and Phase 2 clinical trials in China in pace with the global registrational progress.
IBI3016(AGT siRNA): a new-generation siRNA drug candidate to address unmet need in hypertension. We will collaborate with SanageneBio and plan to initiate a Phase 1 clinical trial in 2024.
Next-generation projects will enter into IND-enabling stage in 2024, underscoring our dedication to expanding our strategic presence in the CVM field
Autoimmune: address global unmet needs in various autoimmune diseases

IBI112 (IL-23p19) : potential long-lasting efficacy advantage and convenient extended dosing intervals for psoriasis. We anticipate completing the Phase 3 registrational clinical trial in support of an NDA submission in 2024.
IBI353 (PDE4): the multi-regional Phase 2b clinical study (led by UNION) of IBI353 in psoriasis attained positive topline results.
IBI355 (CD40L) , IBI356 (OX40L) and IBI3002 (IL-4Rα/TSLP): innovative autoimmune molecules entered into first-in-human studies to explore other unmet medical needs in various types of autoimmune diseases, such as primary Sjögren’s syndrome (pSS), systemic lupus erythematosus (SLE), atopic dermatitis (AD) and asthma.
Ophthalmology: a long-standing commitment to elevate standard-of-care

IBI302 (VEGF/C): Phase 3 study initiated for the treatment of nAMD, based on the observed stable and robust visual benefit under extended dosing interval and potential inhibition effect in macular atrophy in two Phase 2 studies.
IBI311 (IGF-1R): Phase 3 clinical trial met the primary endpoint, demonstrating favorable safety and excellent efficacy; we plan to submit an NDA in 2024
IBI324 (VEGF-A/ANG-2) and IBI333 (VEGF-C/VEGF-A) : both are in the Phase 1 stage to explore the potential differentiation clinical values versus existing therapy.
Global innovation as unwavering long-term strategic priority

Innovent Academy as the innovation powerhouse:
In 2023, Innovent Academy has successfully delivered eight high quality novel molecules into IND enabling stage.
A significant portion of preclinical programs lies in key non-oncology areas, including CVM, ophthalmology and autoimmune diseases, forming another important growth pillar of global innovation as oncology counterparts.
Research innovation published in high-impact scientific journals and medical conferences, such as:
Preclinical results publication of IBI363 in Nature Cancer
Preclinical results of IBI334 (EGFR/B7H3), IBI343 (CLDN18.2 ADC), IBI3001 (EGFR/B7H3 ADC) are accepted as Late-breaking Researches by the American Association for Cancer Research (AACR) (Free AACR Whitepaper) 2024
Manufacturing capacity adhering to high-standard quality:
Suzhou manufacturing site: 60,000L antibody production capacity and ADC production lines in operation
Hangzhou manufacturing site: 170,000L production capacity (first phase of 80,000L completed construction, second phase of 90,000L in plan) to secure global supply
Shanghai R&D center will be operational in 2024
Devoted to responsible business practices and enhancing ESG management practices

Innovent has been upgraded to ‘A’ level in MSCI ESG rating, ranking at the forefront of the biotechnology industry.
In active support of the United Nations’ sustainable development goals (SDGs) and in fulfilling our social responsibilities, we continued to enhance ESG management across several key dimensions, including: "Excellent governance", "Enjoying good health", "High-quality as key", "People first" and "Green ecology".

Antengene Initiates Phase II Dose Expansion Study of Claudin 18.2 ADC ATG-022 in China and Australia

On March 20, 2024 Antengene Corporation Limited ("Antengene" SEHK: 6996.HK), a leading innovative, commercial-stage global biopharmaceutical company dedicated to discovering, developing and commercializing first-in-class and/or best-in-class therapeutics in hematology and oncology, reported that it has initiated the dose expansion portion of the Phase II CLINCH study of ATG-022 (Claudin 18.2 antibody-drug conjugate[ADC]) in China and Australia (Press release, Antengene, MAR 20, 2024, View Source [SID1234641301]). Prior to this, the CLINCH trial has already produced promising preliminary clinical results with partial response (PR) and compete response (CR).

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The CLINCH trial, consists of a dose escalation portion and a dose expansion portion, is a multi-center, open-label Phase I/II study of ATG-022 monotherapy in patients with advanced or metastatic solid tumors. The primary objective of the study is to evaluate the safety and tolerability of ATG-022 and to determine important dosing parameters including maximum tolerated dose (MTD) and recommended Phase II dose (RP2D) of ATG-022 monotherapy. The secondary objective is to characterize the pharmacology and evaluate the preliminary efficacy of ATG-022.

The dose expansion portion of the study will enroll patients with gastric cancer or other solid tumors. In May 2023, the U.S. Food and Drug Administration (FDA) consecutively granted two Orphan Drug Designations (ODDs) to ATG-022 for the treatment of pancreatic cancer and gastric cancer, separately.

Dr. Amily Zhang, Antengene’s Chief Medical Officer, said, "We are excited that the dose expansion portion of the Phase II study of ATG-022 in China and Australia. The Phase I/II CLINCH trial is supported by strong preclinical data and has already made encouraging early observations with one PR and CR in two patients with metastatic gastric cancer. With the trial entering its next critical phase, we will continue working closely with regulators and investigators to fully explore the clinical potential of ATG-022."

About ATG-022

ATG-022 is an antibody-drug-conjugate targeting Claudin 18.2. Claudins are cell adhesion molecules normally expressed within the tight junctions between cells to form a barrier that regulates cell permeability. In cancer, Claudins are expressed at the cell surface due to changes in cell polarity. The Claudin 18.2 is often overexpressed in various primary malignant tumors including gastric, esophageal, cholangiocarcinoma and pancreatic cancers.

Data from preclinical studies, including results from gastric cancer-patient derived xenograft models presented at the 2022 American Association for Cancer Research (AACR) (Free AACR Whitepaper) (2022 AACR (Free AACR Whitepaper)), showed that ATG-022 binds to Claudin 18.2 with low nanomolar affinity and demonstrated potent in vitro and in vivo antitumor effects, including in vivo efficacy demonstrated in Claudin 18.2 low expression models. This could pave the way for broad clinical utility of ATG-022 in gastric cancer patients with a wide range of Claudin 18.2 expression levels. ATG-022 demonstrated an excellent safety profile in Good Laboratory Practice (GLP) toxicology studies.

Phanes Therapeutics’ PT886 granted Fast Track designation for the treatment of patients with metastatic claudin 18.2-positive pancreatic adenocarcinoma by the FDA

On March 20, 2024 Phanes Therapeutics, Inc. (Phanes), a clinical stage biotech company focused on innovative drug discovery and development in oncology, reported that the U.S. Food and Drug Administration (FDA) has granted Fast Track designation to PT886 for the treatment of patients with metastatic claudin 18.2-positive pancreatic adenocarcinoma (Press release, Phanes Therapeutics, MAR 20, 2024, View Source [SID1234641300]). PT886 was also granted orphan drug designation for the treatment of pancreatic cancer by the FDA in 2022.

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PT886, a first-in-class native IgG-like bispecific antibody (bsAb) targeting claudin 18.2 and CD47, is being developed for the treatment of patients with gastric, gastroesophageal junction and pancreatic adenocarcinomas. PT886 was assembled using Phanes’ proprietary bispecific antibody platforms PACbody and SPECpair.

Pancreatic cancer is an aggressive form of cancer characterized by high mortality rates and significant morbidities. For patients who present with metastasis at the time of diagnosis, the 5-year survival rate is only 3%. Projections for 2024 estimate that approximately 51,000 Americans will die of pancreatic cancer this year and by 2030, is projected to exceed breast, prostate, and colorectal malignancies as the leading cause of cancer-related deaths in the US.

"PT886 has the potential to be a transformative treatment option for patients with metastatic claudin 18.2-positive pancreatic adenocarcinoma, for which current standard of care is insufficient," said Ming Wang, Founder and CEO of Phanes Therapeutics. "PT886 is a product of Phanes’ ingenious innovation in creative design of both novel therapeutic approaches and practical technologies."

The multi-center Phase I clinical trial of PT886 (NCT05482893), known as the TWINPEAK study, is currently evaluating the safety, tolerability, pharmacokinetics, pharmacodynamics, and preliminary efficacy of PT886 in patients with locally advanced or metastatic gastric, gastroesophageal junction and pancreatic cancers that have progressed after all available standard therapy or for which standard therapy has proven to be ineffective, intolerable, or is considered inappropriate.

Fusion Pharmaceuticals Reports Fourth Quarter And Full Year 2023 Financial Results And Announces Clinical Program Updates

On March 20, 2024 Fusion Pharmaceuticals Inc. (Nasdaq: FUSN), a clinical-stage oncology company focused on developing next-generation radiopharmaceuticals as precision medicines, reported financial results for the fourth quarter and full year ended December 31, 2023, and provided an update on clinical and corporate developments (Press release, Fusion Pharmaceuticals, MAR 20, 2024, View Source [SID1234641299]).

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Chief Executive Officer John Valliant, Ph.D., commented, "We entered 2024 with strong momentum focused on execution to advance our pipeline of targeted alpha therapies, and we are pleased to recently have achieved several critical milestones. For our lead program, FPI-2265, we expect to initiate the Phase 2 portion of the registrational program in metastatic castration-resistant prostate cancer (mCRPC) in the second quarter of this year. Acknowledging the substantial and expanding market for patients in the post-PLUVICTO setting we believe FPI-2265, which is positioned to be the first actinium-based PSMA targeted radiopharmaceutical to market, will effectively address a crucial unmet need for patients with progressive disease. We look forward to presenting data from the TATCIST trial at AACR (Free AACR Whitepaper) in April.

Dr. Valliant continued, "We also continue to advance our other clinical-stage programs, including the ongoing Phase 1 study of FPI-1434, which has demonstrated a promising safety profile and early evidence of antitumor activity. We expect to provide an update on this program around mid-year 2024. Underpinning our platform, which has produced a robust pipeline of targeted alpha therapies, is our state-of-the-art GMP manufacturing facility now operational and producing clinical doses of FPI-2265. With a strong balance sheet and secured actinium supply, we are well positioned to execute on our commitment of bringing this next generation of radiopharmaceuticals to patients in need."

Corporate Update

On March 19, 2024, Fusion announced the Company has entered into a definitive agreement to be acquired by AstraZeneca. Under the terms of the agreement, AstraZeneca, through a subsidiary, will acquire all of Fusion’s outstanding shares pursuant to a plan of arrangement for a price of $21.00 per share in cash at closing plus a non-transferable contingent value right (CVR) of $3.00 per share in cash payable upon the achievement of a specified regulatory milestone.

The upfront cash portion of the consideration represents a transaction value of approximately $2 billion, a 97% premium to Fusion’s closing market price of $10.64 on March 18, 2024. Combined, the upfront and maximum potential contingent value payments represent, if achieved, a transaction value of approximately $2.4 billion, a 126% premium to Fusion’s closing market price on March 18, 2024. As part of the transaction, AstraZeneca will acquire the cash, cash equivalents and short-term investments on Fusion’s balance sheet, which totaled $234 million as of December 31, 2023.

The transaction is expected to close in the second quarter of 2024, subject to customary closing conditions, including the approval of Fusion shareholders and regulatory clearances.

Portfolio Update

FPI-2265: A 225Ac based radiopharmaceutical targeting prostate specific membrane antigen (PSMA) for the treatment of patients with mCRPC.

In January 2024, the Company announced alignment with the FDA on its Phase 2/3 protocol for FPI-2265 in patients with mCRPC with progressive disease who have previously been treated with a 177Lu-based PSMA radiotherapy. The development plan includes a Phase 2 dose optimization lead-in, which aims to evaluate whether there are added safety and/or efficacy benefits of various dosing regimens in comparison to the validated regimen of 100kBq/kg every eight weeks, expected to be initiated in the second quarter of 2024. This Phase 2 portion is expected to complete enrollment of approximately 60 patients by the end of 2024. Following analysis of the Phase 2 data and an end of Phase 2 meeting to determine the recommended Phase 3 dosing regimen with the FDA, a Phase 3 global registrational trial in approximately 550 patients is expected to begin in 2025.
The TATCIST trial, which began as an investigator sponsored study, is designed to evaluate FPI-2265 in 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 radiopharmaceutical therapy, completed target enrollment of 25-30 patients. The Company announced that interim data will be presented at the upcoming 2024 American Association for Cancer Research (AACR) (Free AACR Whitepaper) Annual Meeting in April.
The Company is also pursuing the opportunity to potentially move this therapeutic candidate into earlier lines of treatment with combinations of FPI-2265 and olaparib. Fusion expects to initiate a combination trial in the first half of this year.
FPI-1434: Targeting insulin growth factor 1 receptor (IGF1R).

In January 2024, Fusion announced encouraging early findings from Cohort 2 in the cold/hot dosing arm of the ongoing Phase 1, multi-center, open-label clinical trial. The 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. No dose limiting toxicities (DLTs) were observed to date in the 25 kBq/kg dose cohort. Two out of three patients completed the DLT period, and one pancreatic cancer patient discontinued treatment due to disease progression. Evidence of anti-tumor activity was observed in a heavily pre-treated patient with Ewing sarcoma after a single dose and a second patient receiving four cycles of therapy demonstrated stable disease as best response.
The Company plans to complete and further evaluate results from Cohort 2 and hold a Safety Review Committee (SRC) meeting to evaluate the emerging data. Fusion plans to share more details on the data and the FPI-1434 development program in mid-2024.
FPI-2059: Targeting neurotensin receptor 1 (NTSR1).

Patient enrollment and dosing is ongoing in the Phase 1, multi-center, open-label clinical trial 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. 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: A bispecific IgG-based targeted alpha therapy (TAT) targeting EGFR-cMET.

FPI-2068 is currently being evaluated in a Phase 1 study and is being jointly developed with AstraZeneca under the companies’ multi-asset collaboration agreement. FPI-2068 is a bispecific IgG-based 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. The investigational new drug (IND) application has been cleared and Fusion is currently activating clinical trial sites.
Other Recent Updates

In January 2024, Fusion announced it had completed validation of its state-of-the-art GMP manufacturing facility and produced the first clinical dose of a TAT. The facility, which has clinical and commercial scale manufacturing capacity, is designed to support the Company’s growing pipeline of TATs and is expected to be capable of producing more than 100,000 doses per year.
In February 2024, Fusion announced that it has entered into a licensing agreement with Heidelberg University and Euratom represented by the European Commission, Joint Research Centre (together, the "Licensors"). The license agreement grants Fusion exclusive worldwide rights to utilize, develop, manufacture and commercialize compounds covered by the patent, which includes 225Ac-PSMA I&T ("FPI-2265") for the treatment of prostate specific membrane antigen (PSMA)-expressing cancers. In addition, Fusion and the Licensors have signed an agreement to settle the parties’ dispute related to an inter partes review ("IPR") of the patent which was instituted in August 2023 by the United States Patent and Trademark Board.
Fourth Quarter 2023 Financial Results

Cash and Investments: As of December 31, 2023, Fusion held cash, cash equivalents and investments of $247.3 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 December 31, 2023, together with net proceeds from sales of common shares under the Company’s at-the-market equity offering program received in January and February 2024 and net proceeds of $14.9 million from a draw down under the Company’s existing debt facility in January 2024, will be sufficient to fund operations into the fourth quarter of 2025.
R&D Expenses: Research and development expenses for the fourth quarter of 2023 were $20.6 million, compared to $17.6 million for the same period in 2022. The increase was primarily due to increased manufacturing-related expenditures, as well as increased personnel-related costs.
G&A Expenses: General and administrative expenses for the fourth quarter of 2023 were $7.6 million, compared to $6.9 million for the same period in 2022. The increase was primarily due to increased consulting and personnel-related costs.
Net Loss: For the fourth quarter of 2023, Fusion reported a net loss of $28.2 million, or $0.39 per share, compared with a net loss of $24.6 million, or $0.55 per share, for the same period in 2022.
Upcoming Presentations

Fusion will present data in a poster presentation at the American Association for Cancer Research (AACR) (Free AACR Whitepaper) Annual Meeting being held in San Diego, CA, April 5-10, 2024.

Title: Preliminary efficacy and safety results from the (TACIST) trial: A PSMA-directed targeted alpha therapy with FPI-2265 (225Ac-PSMA-I&T) for the treatment of metastatic castration-resistant prostate cancer (mCRPC)
Session: Phase II Clinical Trials 1
Date and Time: Tuesday April 9, 2024 9:00 AM – 12:30 PM PT
Location: Poster Section 49
Abstract Number: CT224